OPERATOR’S MANUAL
AUTOMATED HEMATOLOGY ANALYZER
KX-21N(North American Edition)
CHAPTER 1: INTRODUCTION
CHAPTER 2: SAMPLE ANALYSIS
CHAPTER 3: DISPLAY AND PROCESSING OF ANALYSIS RESULTS
CHAPTER 4: MAINTENANCE AND SUPPLIES REPLACEMENT
CHAPTER 5: QUALITY CONTROL
CHAPTER 6: CALIBRATION
CHAPTER 7: TROUBLESHOOTING
CHAPTER 8: ADJUSTMENT
CHAPTER 9: FUNCTIONAL DESCRIPTION
CHAPTER 10: INSTRUMENT SETUP
APPENDIX A: INSTALLATION
APPENDIX B: TECHNICAL INFORMATION
INDEX
SYSMEX CORPORATION
KOBE, JAPAN
Copyright  1999 - 2003 by SYSMEX CORPORATION
All rights reserved. No part of this Operator’s Manual may be Code No. 461-2264-1
reproduced in any form or by any means whatsoever without PRINTED IN JAPAN
prior written permission of SYSMEX CORPORATION. Date of Last Revision: May 2003
Sysmex KX-21N Operator’s Manual -- Revised February 2000
• Sysmex is a registered trademark of SYSMEX CORPORATION.
• CELLCLEAN, CELLPACK, EIGHTCHECK-3WP, and STROMATOLYSER-WH are
trademarks of SYSMEX CORPORATION.
• Cubitainer is a registered trademark of Hedwin Corporation.
• ESC/P is a registered trademark of Seiko Epson Corporation.
• PCL is a registered trademark of Hewlett-Packard Company.
• Teflon is a registered trademark of E.I. du Pont de Nemours & Co., Inc.
• VENOJECT is a registered trademark of Terumo Corporation.
• Other trademarks referenced are property of their respective owners.
• It is prohibited to reproduce part or all of the contents of this Manual without permission.
• The display screens carried in this Manual may in some cases differ from actual screens.
• We reserve the right to make further improvements and incorporate them in our products,
which then will have some points that differ from descriptions in this Manual.
• Patient names and doctor names are entered for information and illustration purposes only,
and do not imply real specific persons.
Sysmex KX-21N Operator’s Manual -- October 1999 I
RECEIVING INSTRUCTIONS
The KX-21N has been thoroughly tested before shipment, and has been packaged
carefully to prevent damage from shipping and handling. Reagents and options have
also been sent and will arrive at approximately the same time as the analyzer. Follow
these guidelines when the system arrives:
• Check to see that the arrows on the sides of the packages are pointing up. If the
arrows do not point up, remark this information on the bill of lading.
• Visually inspect the outside of the package for rips, dents, or possible shipping
damage. Document any sign of damage on the bill of lading, regardless of how
insignificant it may appear. This is for your protection!
• Notify your service representative that the KX-21N system and its components
have arrived.
• Wait for your service representative to unpack the system and open the
packages.
• Follow the unpacking and storage instructions provided on the outside of the
package. Special requirements such as refrigeration are clearly marked on the
outside of the carton and will be included in the unpacking instructions and
package inserts.
WARRANTY INFORMATION
All instruments manufactured by Sysmex® are warranted against defective materials
or workmanship for a period of one year commencing on the installation date at the
customer's required location.
This Warranty does not cover any defect, malfunction, or damage due to:
1. Accident, neglect or willful mistreatment of the product
2. Failure to use, operate, service, or maintain the product in accordance with the
applicable Sysmex Operator's Manual
3. Failure to use the appropriate reagents or chemicals specified for the product
Sysmex KX-21N Operator’s Manual -- October 1999II
ENSURE SAFE OPERATION OF THE INSTRUMENT
Before operating this instrument, carefully read the "Ensure Safe Operation of the Instrument"
and OPERATOR’S MANUAL, and strictly follow the instructions given in them.
This manual carries a variety of illustrations to make sure that the product can be used safely
and correctly, thus preventing you and others from suffering injuries and damage to property.
The illustrations and meaning are described in the following.
Do understand what they mean before proceeding to the text of the MANUAL.
Meaning of Signs
• If this sign is ignored and the instrument is operated incorrectly, there is
a potentially hazardous situation which could result in death or serious
injury of an operator, or grave property damage.
• If this sign is ignored and the instrument is operated incorrectly, there is
a potentially hazardous situation which may result in injury of an
operator, adverse effect on output results, or will cause property
damage.
Caution on Diagnosis
• This product is a clinical instrument for screening of abnormalities.
Clinical judgments by physicians should take into account results from
clinical examinations and other test results besides hematology result.
WARNING
CAUTION
CAUTION
Sysmex KX-21N Operator’s Manual -- October 1999 III
WARNING
• In the event the instrument emits abnormal odor or any smoke, turn off the power
immediately and disconnect the power plug from the wall socket.
If the instrument is used continuously in that state, there is a hazard that fire, electrical shock, or
injury may result.
Contact your Sysmex service representative for inspection.
• Take care not to spill blood or reagent, or drop wire staples or paper clips into the
instrument.
Those might cause short circuit or smoke emission. If such trouble should occur, turn off the power
supply immediately and pull off the power plug from the wall socket. Then contact Sysmex service
representative for inspection.
• Do not touch the electrical circuits inside the cover. Especially if your hands are
wet, there is a hazard that electrical shock may result.
• Always wear rubber gloves when performing maintenance work or inspection.
Use specified tools and parts.
After work is over, wash your hands with disinfectant.
There is a possibility that those areas of the hand which came in contact with blood could suffer
infection, electrical shock, or burn.
• Be careful when handling samples.
Always wear rubber gloves; otherwise infection by bacteria could result. If bacteria happen to enter
your eye or a cut, wash it off with plenty of water, and immediately see a doctor.
• When discarding waste liquid, or disassembling/assembling the related parts, do
not touch the waste liquid.
If it is contaminated with blood, infection of bacteria may result. If you should touch the waste liquid
inadvertently, wash it off with disinfectant first, then wash it off with soap.
When Handling Reagent
• If a reagent happens to enter your eye, wash it off immediately using plenty of
water, and take medical treatment at once.
• If you should swallow it inadvertently, call for a doctor immediately, drink plenty of
water, and throw up.
• If it happens to adhere to the hand or the skin of other area, wash it off using
plenty of water.
• When discarding waste liquid and instrument consumable, take proper disposing
steps as medical, ineffective, and industrial wastes.
If they are contaminated with blood, infection of bacteria may result.
• Do not modify the instrument. (Modification is prohibited by Pharmaceutical
Affairs Law in Japan.) Check the regulations that apply to laboratories in your
country.
Sysmex KX-21N Operator’s Manual -- October 1999IV
WARNING
Power Supply, Connection, and Grounding
• Never put the power plug in any socket other than the specified voltage.
Otherwise, fire or electrical shock will result.
• When installing the instrument, be sure to ground it.
Otherwise, fire or electrical shock will result.
Handling Power Supply Cord
• Take care not to damage the power cord, place a heavy device on it, or pull it
forcibly.
Otherwise, the wire may break causing fire or electrical shock.
• When connecting the instrument to a peripheral (host computer, printer), be sure
to switch off the power supply beforehand.
Otherwise, electrical shock or instrument failure may result.
Sysmex KX-21N Operator’s Manual -- October 1999 V
CAUTION
Use of Reagents
• After unpacking, be sure not to allow dust, dirt, or bacteria to come in touch with
the reagent.
• Do not use reagents which are out of the expiration date.
• Handle a reagent gently to prevent formation of bubbles.
• Take care not to spill a reagent. If it spills, wipe it off immediately using a wet
cloth or the like.
• Follow other instructions described on the Package Insert on each reagent.
Use of Instrument
• When performing maintenance work or inspection, use specified tools and parts.
Do not use substitute parts, or modify the instrument. It is hazardous.
• Do not bring your body or clothes close to the instrument.
• Those who have no or only limited experience in using reagents are
recommended to have guidance or assistance of those with sufficient
experience.
• If the instrument has developed a trouble by any chance, a person in charge of it
should take steps within the range specified in the OPERATOR’S MANUAL. As to
troubles other than mentioned in it, contact Sysmex service representative for
repair.
• Unpacking, installation, and confirmation of initial operation must be done by
Sysmex service representative.
Environment for Use
• Install the instrument in a place which is not subject to water splash.
• Install the instrument in a place which is not subject to adverse effects of high
temperature, high humidity, dust, direct sunlight, etc.
• Do not give the instrument a strong vibration or impact.
• Do not install the instrument near a chemical storage or a place where a gas is
generated.
Sysmex KX-21N Operator’s Manual -- October 1999 N.A.VI
STRUCTURE OF THIS MANUAL
Read this manual carefully so you will be able to use the instrument to its full extent, and
operate it correctly. This manual contains ten Chapters and APPENDICES as listed in the
following:
Chapter 1: Introduction Describes overview of this instrument, including the
outline of the instrument, operation procedure, and
messages, and cautions during installation.
Chapter 2: Sample Analysis Describes procedures for start-up of the instrument,
measurement of the sample, and shut-down.
Summarizes the operation method for analyzing the
sample.
Chapter 3: Display and Processing of
Analysis Results
Describes the displayed content of the analysis data,
and the process of the latest sample/stored data.
Also describes the manual analysis and the external
output.
Chapter 4: Maintenance and Supplies
Replacement
Describes scheduled maintenance and replacement
method of supplies such as reagent.
Chapter 5: Quality Control Describes execution procedures of the X control and L-
J control for quality control.
Chapter 6: Calibration Describes procedures for automatic, manual, and
calibrator calibration.
Chapter 7: Troubleshooting Describes error messages and troubleshooting.
Chapter 8: Adjustment Describes the method of pressure adjustment based on
the troubleshooting.
Chapter 9: Functional Description Describes the analyzing principles of this instrument
and names of the components.
Chapter 10: Instrument Setup Describes the system environment setting such as
date, time, and unit, and the data analysis setting such
as data error judgment.
Appendix A: Installation Describes the installation method of the KX-21N.
Appendix B: Technical Information Technical reference data describing the specification for
host output format.
Sysmex KX-21N Operator’s Manual -- October 1999 VII
INTRODUCTION
Thank you for purchasing the Sysmex®
Automated Hematology Analyzer KX-21N.
Carefully read the OPERATOR'S MANUAL for correct use of the unit.
Keep this MANUAL handy after reading. It will continue to be of your service in finding
specific information about this instrument.
Ordering of Supplies and Replacement Parts
If you need to order supplies or replacement parts, please contact your local Sysmex
representative.
Service and Maintenance
Please contact the Service Department of your local Sysmex representative.
Training courses
For further information please contact the Sysmex representative in your country.
Sysmex KX-21N Operator’s Manual -- Revised August 2001
Sysmex KX-21N Operator’s Manual -- Revised May 2002 N.A.VIII
PREMISES FOR SIGNS
Meaning of Signs
• If this sign is ignored and the instrument is operated incorrectly, there is
a potentially hazardous situation which could result in death or serious
injury of an operator, or grave property damage.
• If this sign is ignored and the instrument is operated incorrectly, there is
a potentially hazardous situation which may result in injury of an
operator, adverse effect on output results, or will cause property
damage.
CAUTION: • Indicates what we would like you to know to maintain instrument
performance and prevent its damage.
NOTE: • Indicates information which will come handy in operating the instrument.
Document Conventions
In explaining operation, this manual uses the conventions as shown below.
• The keys on the panel keyboard are expressed within square brackets.
For example: [SELECT], [ENTER], [ ]
• The display on LCD appears within quotation marks.
For example: "Stand-by," "WB"
• The name of menu appears within quotation marks.
For example: "2: Quality Control," "6: Settings"
NOTE: • LCD and printing described in this manual may differ from that in
practice.
• Due to the improvement of the product, the content of this manual may
not conform with the product.
WARNING
CAUTION
Sysmex KX-21N Operator’s Manual -- October 1999 i
KX-21N OPERATOR’S MANUAL
TABLE OF CONTENTS
CHAPTER 1: INTRODUCTION
1. INTRODUCTION.......................................................................................1-1
2. OVERVIEW OF INSTRUMENT...............................................................1-2
3. OPTION UNITS..........................................................................................1-3
4. OUTLINE OF OPERATION......................................................................1-4
5. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT ....................1-4
6. ANALYSIS PARAMETERS......................................................................1-5
7. PANEL KEYBOARD.................................................................................1-7
8. GRAPHIC SCREEN ...................................................................................1-8
8.1 Contents of Display............................................................................1-8
8.2 Status Display Messages....................................................................1-9
8.3 LCD Brightness Adjustment............................................................1-12
9. EMERGENCY STOP PROCEDURE.......................................................1-12
10. ALARM SOUNDS....................................................................................1-13
11. CONTENTS OF PACKAGE.....................................................................1-13
12. INSTALLATION ENVIRONMENT........................................................1-14
12.1 Installation and Relocation...............................................................1-14
12.2 Grounding.........................................................................................1-14
12.3 Installation Space .............................................................................1-15
12.4 Installation Environment..................................................................1-16
13. INSTRUMENT SPECIFICATIONS.........................................................1-17
14. MENU TREE.............................................................................................1-20
CHAPTER 2: SAMPLE ANALYSIS
1. INTRODUCTION.......................................................................................2-1
1.1 Overview of Analysis Modes.............................................................2-1
1.2 Analysis Procedure Flow Chart..........................................................2-2
2. START-UP PROCEDURE..........................................................................2-3
2.2 Inspection before Turning ON the Power ..........................................2-3
2.2 Turning ON the Power and Self-Check .............................................2-5
3. QUALITY CONTROL................................................................................2-8
4. PROCEDURES IN EACH ANALYSIS MODE.........................................2-9
4.1 Whole Blood (WB) Mode.................................................................2-9
4.2 Pre-Diluted (PD) Mode....................................................................2-16
5. DISPLAY AND PRINTING OF ANALYSIS RESULT..........................2-24
5.1 Display of Analysis Result...............................................................2-24
5.2 Printing of Analysis Result...............................................................2-25
5.3 Output of Analysis Result to Host Computer...................................2-27
6. LIMITATIONS..........................................................................................2-28
6.1 Cell Count Parameters......................................................................2-28
6.2 Limitation of Hemoglobin................................................................2-29
7. EXPECTED RESULTS.............................................................................2-30
8. STOPPING THE PNEUMATIC UNIT.....................................................2-31
9. EXECUTION OF SHUTDOWN ..............................................................2-32
9.1 Shutdown Procedure.........................................................................2-32
ii Sysmex KX-21N Operator’s Manual -- Revised June 2001
CHAPTER 3: DISPLAY AND PROCESSING OFANALYSIS
RESULTS
1. INTRODUCTION...................................................................................... 3-1
2. PROCESSING LATEST SAMPLES......................................................... 3-2
2.1 Display of Analysis Result................................................................ 3-2
2.2 Manual Discrimination...................................................................... 3-7
2.3 External Output ............................................................................... 3-11
3. PROCESSING STORED DATA............................................................. 3-14
3.1 Executing and Quitting Stored Data Processing Program............... 3-14
3.2 Stored Data Screen.......................................................................... 3-15
3.3 Deletion........................................................................................... 3-20
3.4 External Output ............................................................................... 3-21
3.5 Correcting a Sample Number.......................................................... 3-23
CHAPTER 4: MAINTENANCE AND SUPPLIES REPLACEMENT
1. INTRODUCTION...................................................................................... 4-1
2. KX-21N MAINTENANCE CHECKLIST................................................. 4-2
3 DAILY MAINTENANCE AND PROCEDURE....................................... 4-4
3.1 Clean TD Chamber and Diluted Sample Line (Shutdown)............... 4-4
3.2 Check Trap Chamber Level and Discard.......................................... 4-6
4. WEEKLY MAINTENANCE AND PROCEDURE................................... 4-7
4.1 Clean SRV Tray .................................................................................4-7
5. MONTHLY MAINTENANCE AND PROCEDURE................................ 4-9
5.1 Clean Waste Chamber (Rinse Sequence)...........................................4-9
5.2 Clean Transducer (Rinse Sequence).................................................4-12
6. EVERY 3-MONTH MAINTENANCE AND PROCEDURE................. 4-16
6.1 Clean Sample Rotor Valve (SRV)....................................................4-16
6.2 Reset SRV Cycle Counter ...............................................................4-22
7. AS-NEEDED MAINTENANCE AND PROCEDURE........................... 4-24
7.1 Auto Rinse........................................................................................4-24
7.2 Clean Rinse Cup...............................................................................4-26
7.3 Clean WBC/RBC Transducer Aperture...........................................4-28
7.4 Replace Waste Tank.........................................................................4-32
8. SUPPLIES REPLACEMENT.................................................................. 4-33
8.1 Replenish Reagent............................................................................4-33
8.2 Replace Fuse.....................................................................................4-36
8.3 Replace Printer Paper.......................................................................4-37
8.4 Supplies List.....................................................................................4-40
9. CONFIRMATION OF CYCLE NUMBER ............................................. 4-41
9.1 Operation Procedure........................................................................ 4-41
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. iii
CHAPTER 5: QUALITY CONTROL
1. INTRODUCTION................................................................. 5-1
1.1 X Control ................................................................... 5-1
1.2 Levy-Jennings Control (L-J) .............................................. 5-1
1.3 QC Chart Screen............................................................ 5-2
2. QC ANALYSIS PROCEDURE ................................................. 5-4
2.1 QC Analysis Procedure Flow Chart...................................... 5-4
2.2 Execute QC Program....................................................... 5-5
2.3 Select QC File............................................................... 5-6
2.4 Erase All ..................................................................... 5-7
2.5 Set TARGET/LIMIT Values.............................................. 5-8
2.6 Execute X Control.........................................................5-10
2.7 Execute L-J Control .......................................................5-19
2.8 Exit from QC Control Program..........................................5-26
3. DELETION........................................................................5-27
4. EXTERNAL OUTPUT ..........................................................5-31
4.1 Printing to Printer..........................................................5-31
4.2 Output to Host Computer.................................................5-35
CHAPTER 6: CALIBRATION
1. INTRODUCTION ................................................................ 6-1
1.1 Calibration .................................................................. 6-1
1.2 Calibrator Calibration Program .......................................... 6-1
2. PREPARATION FOR CALIBRATION....................................... 6-2
2.1 Precision Check ............................................................ 6-2
2.2 Precision Check Sample .................................................. 6-2
2.3 HGB/HCT Calibration Samples ......................................... 6-3
2.4 Reference Values .......................................................... 6-3
2.4.1 Calibrator Calibration ............................................. 6-3
2.4.2 HGB/HCT Calibration ............................................ 6-3
2.5 Calibration Flow Chart.................................................... 6-4
3. AUTOMATIC CALIBRATION ................................................ 6-5
3.1 Executing Automatic Calibration Program............................. 6-5
3.2 Automatic Calibration Procedure........................................ 6-6
4. MANUAL CALIBRATION....................................................6-11
4.1 Calculating Calibration Value...........................................6-11
4.2 Manual Calibration Procedure ..........................................6-12
5. CALIBRATOR CALIBRATION..............................................6-15
5.1 Executing Calibrator Calibration Program ............................6-15
5.2 Calibrator Calibration Procedure .......................................6-17
6. CALIBRATION HISTORY PRINT...........................................6-25
iv Sysmex KX-21N Operator’s Manual -- Revised June 2001
CHAPTER 7: TROUBLESHOOTING
1. INTRODUCTION...................................................................................... 7-1
2. WHEN YOU SUSPECT A TROUBLE..................................................... 7-2
2.1 Alphabetical List of Error Messages
Displayed on Analysis Screen.......................................................... 7-3
2.2 Alphabetical List of Error Messages Displayed on HELP Screen... 7-4
2.3 Functional List of Error Messages ................................................... 7-5
3. TROUBLESHOOTING GUIDE................................................................ 7-7
3.1 Pressure/Vacuum Errors................................................................... 7-7
3.2 Chamber Errors .............................................................................. 7-10
3.3 Motor Errors................................................................................... 7-13
3.4 Transducer Errors........................................................................... 7-15
3.5 Temperature Errors......................................................................... 7-16
3.6 Analysis Errors............................................................................... 7-17
3.7 Memory Errors............................................................................... 7-23
3.8 Others ............................................................................................. 7-25
3.9 Maintenance Errors ........................................................................ 7-27
3.10 Printer Errors.................................................................................. 7-30
3.11 External Device Errors................................................................... 7-33
4. STATUS DISPLAY................................................................................. 7-34
5. ERROR HISTORY PRINT...................................................................... 7-36
6. PROGRAM VERSION............................................................................ 7-37
CHAPTER 8: ADJUSTMENT
1. INTRODUCTION.......................................................................................8-1
2. ADJUSTMENT OF PRESSURE AND VACUUM ...................................8-2
2.1 Location of Control Knobs................................................................8-2
2.2 Pressure and Vacuum Display...........................................................8-3
2.3 Adjusting Pressure to 0.05 MPa........................................................8-5
2.4 Adjusting Vacuum to 0.0333 MPa....................................................8-6
Sysmex KX-21N Operator’s Manual -- October 1999 v
CHAPTER 9: FUNCTIONAL DESCRIPTION
1. INTRODUCTION...................................................................................... 9-1
2. DETECTION PRINCIPLE......................................................................... 9-2
2.1 DC Detection Method ....................................................................... 9-2
2.2 Non-Cyanide Hemoglobin Analysis Method.................................... 9-2
3. MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM...... 9-4
4. CBC ANALYSIS........................................................................................ 9-5
4.1 WBC/HGB Analysis Flow................................................................ 9-5
4.2 RBC/PLT Analysis Flow................................................................... 9-7
4.3 Calculation of RBC Constant............................................................ 9-9
5. BLOOD CELL DISCRIMINATION CIRCUIT...................................... 9-10
5.1 WBC Discriminator......................................................................... 9-10
5.2 RBC Discriminator.......................................................................... 9-10
5.3 PLT Discriminator........................................................................... 9-10
6. ANALYSIS OF HISTOGRAM................................................................ 9-11
6.1 Analysis of WBC Histogram........................................................... 9-11
6.2 Analysis of RBC/PLT Histogram.................................................... 9-20
7. ELECTRIC SYSTEM .............................................................................. 9-28
8. NAMES AND FUNCTIONS OF INSTRUMENTS................................ 9-30
8.1 Front Panel ...................................................................................... 9-30
8.2 Front Interior ................................................................................... 9-31
8.3 Right Side Panel.............................................................................. 9-32
8.4 Left Side Panel ................................................................................ 9-33
8.5 Left Side Interior............................................................................. 9-34
8.6 Rear Panel........................................................................................ 9-35
CHAPTER 10: INSTRUMENT SETUP
1. INTRODUCTION.................................................................................... 10-1
2. SYSTEM SETUP ..................................................................................... 10-3
3. DATE/TIME SETTINGS......................................................................... 10-8
4. PATIENT LIMIT.................................................................................... 10-11
5. QC SETTINGS....................................................................................... 10-14
6. HOST SETTINGS.................................................................................. 10-17
7. PRINTER SETTINGS............................................................................ 10-22
7.1 DP Output Settings........................................................................ 10-23
7.2 GP/LP Output Settings.................................................................. 10-25
7.3 IP Output Settings ......................................................................... 10-27
8. ID READER SETTINGS....................................................................... 10-30
9. PASSWORD SETTINGS....................................................................... 10-32
10. PRINT SET VALUES............................................................................ 10-35
11. PERIPHERAL SETTINGS.................................................................... 10-36
12. FACTORY SETTINGS.......................................................................... 10-38
vi Sysmex KX-21N Operator’s Manual -- Revised June 2001
APPENDIX A: INSTALLATION
1. INTRODUCTION......................................................................................A-1
2. CHECK BEFORE INSTALLATION ........................................................A-2
3. INSTALLATION SPACE..........................................................................A-3
4. REMOVE SHIPPING CLAMPS ...............................................................A-4
5. CONNECT TUBE......................................................................................A-6
5.1 Prepare Reagent.................................................................................A-6
5.2 Connect CELLPACK........................................................................A-6
5.3 Connect STROMATOLYSER-WH..................................................A-8
5.4 Connect Waste Line ..........................................................................A-9
6. SET PRINTER PAPER............................................................................A-10
7. CONNECT POWER CORD AND CONNECTING CABLES ...............A-12
7.1 Connect Host Computer, Printer, and Hand Held Barcode Reader A-12
7.2 Connect Power Cord .......................................................................A-12
8. TURN POWER ON..................................................................................A-13
9. REINSTALLING THE PROGRAM........................................................A-13
APPENDIX B: TECHNICAL INFORMATION
1. OUTPUT FORMAT FOR HOST COMPUTER........................................B-1
1.1 HARDWARE....................................................................................B-1
1.2 SOFTWARE .....................................................................................B-3
2. HAND HELD BAR CODE READER SPECIFICATIONS....................B-15
INDEX
Sysmex KX-21N Operator’s Manual -- October 1999
CHAPTER 1 INTRODUCTION
1. INTRODUCTION ................................................................. 1-1
2. OVERVIEW OF INSTRUMENT................................................ 1-2
3. OPTION UNITS................................................................... 1-3
4. OUTLINE OF OPERATION..................................................... 1-4
5. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT................ 1-4
6. ANALYSIS PARAMETERS..................................................... 1-5
7. PANEL KEYBOARD ............................................................. 1-7
8. GRAPHIC SCREEN.............................................................. 1-8
8.1 Contents of Display......................................................... 1-8
8.2 Status Display Messages ................................................... 1-9
8.3 LCD Brightness Adjustment..............................................1-12
9. EMERGENCY STOP PROCEDURE..........................................1-12
10. ALARM SOUNDS ...............................................................1-13
11. CONTENTS OF PACKAGE....................................................1-13
12. INSTALLATION ENVIRONMENT...........................................1-14
12.1 Installation and Relocation ................................................1-14
12.2 Grounding ................................................................. .1-14
12.3 Installation Space...........................................................1-15
12.4 Installation Environment ..................................................1-16
13. INSTRUMENT SPECIFICATIONS...........................................1-17
14. MENU TREE......................................................................1-20
INTRODUCTION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 1-1
1 . INTRODUCTION
The Sysmex® KX-21N is an automatic multi-parameter blood cell counter for in vitro
diagnostic use in clinical laboratories.
The KX-21N processes approximately 60 samples an hour and displays on the LCD screen
the particle distribution curves of WBC, RBC, and platelets, along with data of 17
parameters, as the analysis results.
Chapter 1 introduces the overview of the instrument, analysis procedure, etc. that we
recommend you to read before using the KX-21N. The main contents of Chapter 1 are as
follows:
Overview of Instrument
The important functions of the KX-21N and the options for efficient operation are explained.
Main Points of Analysis Procedure
Explanation is given on the procedure for implementing each analysis mode, descriptions and
functions of the keys on panel keyboard, and the messages on the LCD screen.
Precautions at Time of Installation
Explanation is given on the matters that need to be confirmed before installation, such as
installation space, required equipment, environmental conditions.
Instrument Specifications
The instrument specifications are described.
Menu Tree
This chapter describes the KX-21N menu tree and the corresponding chapters which explain
the usage of the menus.
Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
INTRODUCTION
1-2 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
2 . OVERVIEW OF INSTRUMENT
The KX-21N performs speedy and accurate analysis of 17 parameters in blood and detects
the abnormal samples. To assure easy sorting of abnormal samples in the laboratory, the
instrument displays abnormal analysis data with abnormal marks attached on the LCD
screen. Thus displayed analysis data allows detecting those samples which are outside the
tolerance and need further analysis and reconsideration.
The KX-21N employs three detector blocks and two kinds of reagents for blood analysis.
The WBC count is measured by the WBC detector block using the DC detection method.
The RBC count and platelets are taken by the RBC detector block, also using the DC
detection method. The HGB detector block measures the hemoglobin concentration using
the non-cyanide hemoglobin method.
Figure 1-2-1: Overview of KX-21N
Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
INTRODUCTION
Sysmex KX-21N Operator’s Manual -- October 1999 1-3
3 . OPTION UNITS
This instrument offers several option units to ensure its efficient operation. The options that
can be used with the KX-21N are:
• Graphic Printer: Prints the analysis data obtained from the KX-21N on
letter or A4-size paper.
• Data Printer: Prints the analysis data obtained from the KX-21N onto a
ticket format.
DP-510: 943-0571-9 (N.America, 117 V)
943-0581-6 (Europe, 220 V)
943-0591-3 (U.K., 240 V)
Figure 1-3-1: Data Printer
• Hand Held Barcode Reader: During analysis, reads the barcode that are affixed to the
tubes, and automatically sets the sample ID numbers.
Figure 1-3-2: Hand Held Barcode Reader
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INTRODUCTION
1-4 Sysmex KX-21N Operator’s Manual -- October 1999
4 . OUTLINE OF OPERATION
Two analysis modes are available with the KX-21N: whole blood mode and pre-diluted
mode. Analysis procedures in these modes are listed below.
Whole blood mode Pre-diluted mode
Check before turning ON the power.
Turn ON the power.
• Self-check
• Background check
Ready
Select whole blood mode. Select pre-diluted mode.
Set sample No. Prepare analysis samples in pre-diluted mode
(1:26 dilution).
Set sample No.
Set sample to the sample probe.
Press the start switch.
• Execute analysis.
• End analysis.
Ready
Check after analysis.
Execute shutdown.
Turn off the power.
Table 1-4-1: Outline of Operation
• The work by an operator is shown in shaded cells.
• : "Ready" is displayed on the LCD screen. In this state, various operations
including analysis, settings, and data processing can be performed.
5 . AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT
The KX-21N, when left non-operating for 15 minutes, automatically stops the pneumatic
unit. This function saves power consumption and extends component service life. In
addition, with this function, analysis-ready status can be resumed faster than by turning on
the power.
It is also possible to manually stop the pneumatic unit through the Select Menu screen.
Pressing the Start switch, the instrument will return to “Ready” status.
Ready
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INTRODUCTION
Sysmex KX-21N Operator’s Manual -- October 1999 1-5
6 . ANALYSIS PARAMETERS
This instrument analyzes the following parameters using three detector blocks and two kinds
of reagents:
1) WBC (white blood cell) (Analysis principle: DC detection method)
WBC count in 1 µL of whole blood
2) LYM% [W-SCR] (WBC-Small Cell Ratio)
Ratio (%) of lymphocytes (small cells) to whole WBC
3) MXD% [W-MCR] (WBC-Middle Cell Ratio)
Ratio (%) of the summation of basophils, eosinophils and monocytes (middle cells) to
whole WBC
4) NEUT% [W-LCR] (WBC-Large Cell Ratio)
Ratio (%) of neutrophils (large cells) to whole WBC
5) LYM# [W-SCC] (WBC-Small Cell Count)
Absolute count of lymphocytes (small cells) in 1 µL of whole blood
6) MXD# [W-MCC] (WBC-Middle Cell Count)
Absolute count of the basophils, eosinophils and monocytes (middle cells) in 1 µL of
whole blood
7) NEUT# [W-LCC] (WBC-Large Cell Count)
Absolute count of neutrophils (large cells) in 1 µL of whole blood
8) RBC (red blood cell) (Analysis principle: DC detection method)
RBC count in 1 µL of whole blood
9) HGB (Hemoglobin) (Analysis principle: Non-Cyanide hemoglobin analysis method)
Volume (gram) of hemoglobin in 1 dL of whole blood
10) HCT (Hematocrit value) (Analysis principle: RBC pulse height detection method)
Ratio (%) of whole RBC volume in whole blood
11) MCV (Mean RBC volume)
Mean RBC volume (fL) in whole blood, which is calculated by 10 × Hct (%)/ RBC
(× 106
/µL).
12) MCH (Mean RBC hemoglobin)
Mean hemoglobin volume (pg) per RBC, which is calculated by 10 × Hgb (g/dL)/
RBC (× 106
/µL).
13) MCHC (Mean RBC hemoglobin concentration)
Mean hemoglobin concentration (g/dL), which is calculated by 100 × Hgb (g/dL)/ Hct
(%).
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INTRODUCTION
1-6 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
14) RDW-CV (RBC distribution width - CV)
RBC distribution width (%) calculated from the points defining 68.26% of the entire
area spreading from the peak of the RBC particle distribution curve.
15) RDW-SD (RBC distribution width - SD)
The distribution width (fL) at the height of 20% from the bottom when the peak RBC
particle distribution curve is taken as 100%.
16) PLT (Platelet) (Analysis principle: DC detection method)
Platelet count in 1 µL of whole blood
17) MPV (Mean platelet volume)
Mean volume of platelet (fL)
NOTE: • When analyzing in the pre-diluted mode, only the CBC8 parameters
are output.
Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
INTRODUCTION
Sysmex KX-21N Operator’s Manual -- October 1999 1-7
7 . PANEL KEYBOARD
The KX-21N is provided with the 22-key panel keyboard.
7 8 9
4 5 6
1 2 3
0 -/. C
SAMPLE No.
ENTER
SELECT
MODE
HELP
SHUTDOWN
Figure 1-7-1: Panel Keyboard
Name Function
SAMPLE No. Used to set a sample No.
ENTER Used to fix a sample No., selected menu, etc.
SELECT Used to select a menu. Press this key to display the Select Menu screen. When
you press it while the Select Menu screen is displayed, the Analysis screen returns.
MODE Used to changeover analysis mode (whole blood mode/pre-diluted mode).
HELP Used when an error has occurred.
SHUTDOWN Used to execute shutdown program.
0 - 9 Used to enter numerics such as a sample No. and set value.
−/. Used to enter "−" (hyphen) of a sample No., the decimal point of a set value.
C Used to delete characters when entering numerics, and stop the alarm.
, Used to select a menu. Each time a key is pressed, the cursor moves to the
previous or the next item.
, Used to select conditions when setting, and to select Manual Discriminator.
Table 1-7-1: Functions of Panel Keyboard
CAUTION: • When the alarm is sounding after an error, etc. occurred, press [C] key
to stop it or press [HELP] key to display the HELP screen. By
pressing [HELP] key, the alarm stops and the HELP screen appears.
While the alarm is sounding, the keys other than [C] key and [HELP]
key cannot be used.
INTRODUCTION
1-8 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
8 . GRAPHIC SCREEN
8.1 Contents of Display
31/12 10:20No.0 WB
No.1
PLT 0 P-LCR 0.0
MCHC 0.0 MPV 0.0
MCH 0.0 PDW 0.0
MCV 0.0 RDW-CV 0.0
HCT 0.0 RDW-SD 0.0
HGB 0.0 NEUT% 0.0 0.0
RBC 0.00 MXD% 0.0 0.0
WBC 0.0 LYM% 0.0 0.0
1:M.Discri. 2:Output
Ready
Next Sample No. Analysis Progress StatusStatus Display
Sample Analysis Mode
Menu Display Area
Analysis Result
Display Area
Figure 1-8-1: Graphic LCD
Name Contents of Display
Next Sample No. Displays the sample No. to be analyzed next.
Sample Analysis
Mode
Displays the analysis mode for the sample.
: whole blood mode
: pre-diluted mode
Analysis Progress
Status
With the start-to-end analysis progress classified into six steps, the
present progress status is displayed.
Status Display Status of the unit is displayed.
Menu Display Area Useable menus for each screen are displayed.
Analysis Result
Display Area
The area for displaying analysis result
Table 1-8-1: Contents of Display
Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
INTRODUCTION
Sysmex KX-21N Operator’s Manual -- October 1999 1-9
8.2 Status Display Messages
The KX-21N displays instrument status message on the LCD screen.
This section gives the meanings of status messages displayed on the LCD screen.
Display Message Meaning
Sysmex KX-21N
[00-01]
Please wait.
The instrument is making self-check. When
the power is turned ON, the instrument
checks itself automatically. When the power
is turned ON, [00-01] appears briefly in the
right lower corner, which indicates the version
of the unit control program.
*Auto Rinse*
Please wait.
The hydraulic system is undergoing Auto
Rinse. When the power is turned ON, the
instrument starts self-check and motor check,
followed by auto rinse of the hydraulic
system. Auto rinse is also performed when
"5: Auto Rinse" in the Select menu is
executed and when [SHUTDOWN] key is
pressed. When an automatic background
check shows a background count exceeding
the permissible background count level, rinse
sequence is automatically extended.
INTRODUCTION
1-10 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
Display Message Meaning
31/12 10:20No.0 WB
No.1
PLT 0 P-LCR 0.0
MCHC 0.0 MPV 0.0
MCH 0.0 PDW 0.0
MCV 0.0 RDW-CV 0.0
HCT 0.0 RDW-SD 0.0
HGB 0.0 NEUT% 0.0 0.0
RBC 0.00 MXD% 0.0 0.0
WBC 0.0 LYM% 0.0 0.0
1:M.Discri. 2:Output
Ready
The instrument is ready for analysis in the
whole blood mode. "No." in the left upper
corner indicates the sample No. to be
analyzed next.
31/12 10:20No.0 PD
No.1
PLT WL+000.0 P-LCR WL+000.0
MCHC WL+000.0 MPV WL+000.0
MCH WL+000.0 PDW WL+000.0
MCV WL+000.0 RDW-CV WL+000.0
HCT WL+000.0 RDW-SD WL+000.0
HGB WL+000.0 NEUT% WL+000.0 +000.0
RBC WL+00.00 MXD% WL+000.0 +000.0
WBC WL+000.0 LYM% WL+000.0 +000.0
Ready
1:M.Discri. 2:Output
The instrument is ready for pre-diluted mode
analysis. "No." in the left upper corner shows
the sample No. to be analyzed next.
FILE No.1 QC
X1 X2 X Judgement
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
Ready
The instrument is ready for X control. "FILE
No. 1" in the left upper corner shows QC file
No.
FILE No.1 QC
Data Judgement
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
Ready
The instrument is ready for L-J control. "FILE
No. 1" in the left upper corner shows QC file
No.
INTRODUCTION
Sysmex KX-21N Operator’s Manual -- October 1999 1-11
Display Message Meaning
*Change Mode*
Please wait.
The whole blood mode is turning into the pre-
diluted mode, or the pre-diluted mode is
turning into the whole blood mode.
No.123456789-12345
Aspirating
The sample is being aspirated in whole blood
mode analysis.
No.123456789-12345
Aspirating
The sample is being aspirated in pre-diluted
mode analysis.
No.123456789-12345
Analyzing
Samples are being aspirated, diluted, and
counted.
No.123456789-12345
Rinsing
Hydraulic line is being rinsed.
No.123456789-12345 Replenish Diluent
Not Ready
An error occurs, making analysis impossible.
(When an error occurs, the error message
appears in reversed display in the right upper
area of the LCD screen.)
No.123456789-12345 PU Sleeping
Not Ready
When operation has been suspended over
15 minutes, the compressor power is turned
OFF and this message is displayed. Press
the [START] switch to get ready for analysis.
Momentary power failure occurred.
When the power is turned off without making
shutdown process or when power outage
caused the instrument to stop, this message
appears when the unit is started next time.
*
Ready
When data is automatically output to the host
computer, " * " mark lights up in the right
upper corner of the screen.
INTRODUCTION
1-12 Sysmex KX-21N Operator’s Manual -- October 1999
8.3 LCD Brightness Adjustment
Open the front cover of the instrument. LCD brightness can be adjusted using the brightness
adjustment knob under the panel keyboard. Turning to the right dims the light and turning to
the left brightens it.
DarkLight
Figure 1-8-2: Brightness adjustment knob
NOTE: • If a key input or an operation has not been performed for a fixed time,
the LCD back-light will become slightly dimmer (back-light darkening
function). To return the LCD to its original brightness, press any key.
9 . EMERGENCY STOP PROCEDURE
When there arises the need to stop the instrument urgently because of power outage, etc., in
the laboratory, turn off the instrument power switch.
INTRODUCTION
Sysmex KX-21N Operator’s Manual -- October 1999 1-13
10. ALARM SOUNDS
The KX-21N indicates different situations by five kinds of alarm sounds:
1. Key sound (single beep)
Sounds about 0.1 second when a key on the panel keyboard is pressed.
2. Input error sound (short beep)
Sounds about 1 second when a wrong key is pressed on the panel keyboard.
3. Analysis error sound (long beep)
Sounds when an error occurs in the instrument and continues until you press [C] key
or [HELP] key on the panel keyboard.
4. Sound at sample aspiration
Usually: A single "beep" when the start switch is pressed; "beep, beep" when
aspiration is finished.
Sample No. "0" or in pre-diluted mode: Beep sounds (beep, beep, ...) continue from
pressing the start switch until aspiration ends.
11. CONTENTS OF PACKAGE
The instrument is fully inspected before leaving the factory and carefully packed to withstand
shocks in transit. Upon arrival, check the package to see that there is no external damage.
Sysmex service representative will unpack, install the instrument, and make initial settings.
To confirm the contents of the package, refer to "Appendix A: Installation."
INTRODUCTION
1-14 Sysmex KX-21N Operator’s Manual -- October 1999
12. INSTALLATION ENVIRONMENT
12.1 Installation and Relocation
The KX-21N is installed by Sysmex Service representative. In case relocation becomes
necessary after installation, contact your Sysmex service representative.
Pay careful attention to this because if relocation, etc. of the instrument should be conducted
by the customer, resulting in any trouble, warranty would not be applied even in the
warranty period.
12.2 Grounding
The instrument power supply cord uses the 3-prong plug. When the power supply socket is
3-prong with grounding, simply plug it to the socket.
117 VAC Spec. 220 VAC Spec. 240 VAC Spec.
Figure 1-12-1: Plugs
• Make sure to ground the instrument. Inadequate grounding could cause
electrical shocks.
NOTE: • The number of power supply sockets required is 3 including optional
Graphic Printer and optional Data Printer.
WARNING
INTRODUCTION
Sysmex KX-21N Operator’s Manual -- October 1999 1-15
12.3 Installation Space
To ensure that the instrument fulfills its function, it is important to install it at an appropriate
place:
• Choose a place that is close to the power supply and proper waterway.
• Secure a place spacious enough for maintenance and service. Giving consideration to
heat radiation by the instrument, provide at least 50 cm distance from the wall to side,
rear, and top panels. You may need some more desktop space if optional Graphic Printer
and Data Printer are provided.
• Choose a place where reagent is easy to handle.
The instrument dimensions are shown below. The power supply cord is 1.8 m long, the
waste tube up to 6 m long, and the diluent (CELLPACK) tube up to 2 m long.
Width (mm) Depth (mm) Height (mm) Weight (kg)
Main Unit 420 355 480 30
Table 1-12-1: Instrument Dimensions
480
355
420
Figure 1-12-2: Instrument Dimensions
CAUTION: • When the diluent (CELLPACK) tube is more than 2 m long, it may be
impossible to have reagent aspirated. Avoid setting CELLPACK at a
level higher than the instrument; otherwise, reagent may flow into the
vacuum line, possibly damaging the instrument.
INTRODUCTION
1-16 Sysmex KX-21N Operator’s Manual -- October 1999
12.4 Installation Environment
• Use the instrument at an ambient temperature of 15°C - 30°C (optimum: 23°C).
• Use it at a relative humidity range of 30% - 85%.
• When air conditioning is used, the maximum cooling capacity of about 172 kcal/hour is
required to offset the heat from the instrument.
• Avoid a place that can become extremely hot or cold.
• Avoid a place that can be exposed to direct sunlight.
• Choose a well-ventilated place.
• Avoid a place close to a wireless telegraph or communication facility where high
frequency waves can be generated or radio interference can occur.
INTRODUCTION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 1-17
13. INSTRUMENT SPECIFICATIONS
Analysis parameters:
WBC (White Bloodcell Count), RBC (Red Bloodcell Count), HGB (hemoglobin), HCT
(hematocrit), MCV (mean corpuscular volume), MCH (mean corpuscular hemoglobin),
MCHC (mean corpuscular hemoglobin concentration), PLT (platelet), RDW-SD (RBC
distribution width-standard deviation), RDW-CV (RBC distribution width-coefficient of
variation), MPV (mean platelet volume), LYM% (W-SCR), MXD% (W-MCR), NEUT%
(W-LCR), LYM# (W-SCC), MXD# (W-MCC), NEUT# (W-LCC)
However, the parameters in pre-diluted mode are eight: WBC, RBC, HGB, HCT, MCV,
MCH, MCHC, PLT.
Display range
WBC 0.0 - 299.9 (×103
/µL)
RBC 0.00 - 19.99 (×106
/µL)
HGB 0 - 25.0 (g/dL)
PLT 0 - 1999 (×103
/µL)
Reagent
Diluent: CELLPACK
WBC/HGB lyse reagent: STROMATOLYSER-WH
Detergent
CELLCLEAN
Consumption of reagent (per sample)
Diluent (CELLPACK): Approx. 30 mL
WBC/HGB lyse reagent (STROMATOLYSER-WH): Approx. 1.0 mL
Throughput
Approx. 60 samples/hour
Analysis principle
WBC: DC detection method
RBC: DC detection method
HGB: Non-cyanide hemoglobin analysis method
INTRODUCTION
1-18 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
Reproducibility
Reproducibility is within the following range at the reliability level of 95%.
1) Whole blood mode
WBC (4.0 × 103
/µL or over) 3.5% or less
RBC (4.00 × 106
/µL or over) 2.0% or less
HGB 1.5% or less
HCT 2.0% or less
MCV 2.0% or less
MCH 2.0% or less
MCHC 2.0% or less
PLT (100 × 103
/µL or over) 6.0% or less
LYM# (W-SCC) 15.0% or less
MXD# (W-MCC) (1.0 × 103
/µL or over) 30.0% or less
NEUT# (W-LCC) 15.0% or less
LYM% (W-SCR) 15.0% or less
MXD% (W-MCR) (12% or over) 30.0% or less
NEUT% (W-LCR) 15.0% or less
RDW-SD or RDW-CV 4.0% or less
MPV 5.0% or less
2) Pre-diluted mode
WBC (4.0 × 103
/µL or over) 6.0% or less
RBC (4.00 × 106
/µL or over) 3.0% or less
HGB 2.5% or less
HCT 3.0% or less
MCV 3.0% or less
MCH 3.0% or less
MCHC 3.0% or less
PLT (100 × 103
/µL or over) 9.0% or less
Accuracy
1) Whole blood mode
WBC: ±3% or ±0.2 × 103
/µL
RBC: ±2% or ±0.03 × 106
/µL
PLT: ±5% or ±10 × 103
/µL
2) Pre-diluted mode
WBC: ±5% or ±0.3 × 103
/µL
RBC: ±3% or ±0.05 × 106
/µL
PLT: ±8% or ±15 × 103
/µL
Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.
INTRODUCTION
Sysmex KX-21N Operator’s Manual -- October 1999 1-19
Linearity
1) Whole blood mode
WBC: 1.0 - 9.9 (× 103
/µL) ±0.3 (× 103
/µL)
10.0 - 99.9 (× 103
/µL) ±3%
RBC: 0.30 - 0.99 (× 106
/µL) ±0.03 (× 106
/µL)
1.00 - 7.00 (× 106
/µL) ±3%
HGB: 0.1 - 10.0 (g/dL) ±0.2 (g/dL)
10.0 - 25.0 (g/dL) ±2%
HCT: 10.0 - 33.3 (HCT%) ±1.0 (HCT%)
33.4 - 60.0 (HCT%) ±3%
PLT: 10 - 199 (× 103
/µL) ±10 (× 103
/µL)
200 - 999 (× 103
/µL) ±5%
(However, RBC < 7.00 × 106
/µL)
Carryover
WBC: 3% or less
RBC: 1.5% or less
HGB: 1.5% or less
HCT: 1.5% or less
PLT: 5% or less
Blood volume aspirated
Whole blood mode: Approx. 50 µL
Pre-diluted mode: Approx. 200 µL (Diluted blood sample)
Blood volume required for the pre-dilution is 20 µL or over.
Power supply
117/220/230/240 VAC ± 10% (50/60 Hz)
Power consumption
Approx. 230 VA or less
Heat Compensation Required
Approx. 785 BTU/h (198 kcal/h)
Dimensions
Main Unit: 420 (W) × 355 (D) × 480 (H) mm
Weight
Main Unit: Approx. 30.0 kg
Protection Type
Class I Equipment
EMC (Electro-magnetic compatibility)
This equipment is in conformity to the following IEC (EN) standard.
IEC 61326-1: 97+A1: 98 (EN 61326: 97+A1) Electrical equipment for measurement, control
and laboratory use -EMC requirements-
-EMI (Class A)
-EMS (Minimum Immunity test requirements)
Sysmex KX-21N Operator’s Manual -- Revised August 2001
INTRODUCTION
1-20 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
14. MENU TREE
*
*
*
*
*
*
*: If set, password has to be entered.
SELECT
SAMPLE No.
MODE
HELP
SHUTDOWN
1: Stored Data
Chapter 4
Ana. Screen
4: Replace
Lyse
3: Calibration
8: Periph.
Settings
7: Maintenance
2: Clean Transducer
3: Reset SRV Counter
4: Drain TD Chamber
5: Status Display
6: Error History
7: Program Maintenance
1: HGB
2: HGB/HCT
3: HCT
1: M. Discri.
2: Output
Chapter 3, 2.2
Chapter 3, 3.3
Chapter 3, 3.4
Chapter 3
Chapter 5, 2
Chapter 5, 2.5
Chapter 5, 2.4
Chapter 6, 2
Chapter 6, 3
Chapter 3, 2.3
Chapter 4, 8.1
Chapter 4, 7.1
Chapter 3
Chapter 5
Chapter 6
Chapter 10 Chapter 10, 2
Chapter 10, 3
Chapter 10, 4
Chapter 10, 5
Chapter 10, 6
Chapter 10, 7
Chapter 10, 8
Chapter 10, 9
Chapter 10,10
Chapter 4, 5.1
Chapter 4, 5.2
Chapter 4, 6.2
Chapter 4, 7.3
Chapter 7, 4
Chapter 7, 5
Chapter 7, 6
Chapter 6, 2
Chapter 6, 2
Chapter 6, 2
1: System Setup
2: Date/Time
3: Patient Limit
4: QC Settings
5: Host Settings
6: Printer Settings
7: ID Reader Settings
8: Password Settings
9: Print Set Values
Chapter 10, 9
00: PU Sleep Chapter 2, 6
Chapter 2, 4
Chapter 2, 4
Chapter 2, 6
Chapter 7, 1
2: Output
3: Chg. Disp.
1: Delete
1: QC Analyze
3: Erase All
2: Settings
6: Settings
1: Auto Cal.
2: Manual Cal.
Chapter 63: Calibrator
Chapter 6, 44: Print Rev. History
5: Auto Rinse
1: Clean W. Chamber
2: Quality
Control
Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
Sysmex KX-21N Operator’s Manual -- October 1999
CHAPTER 2 SAMPLE ANALYSIS
1. INTRODUCTION ................................................................. 2-1
1.1 Overview of Analysis Modes.............................................. 2-1
1.2 Analysis Procedure Flow Chart ........................................... 2-2
2. START-UP PROCEDURE....................................................... 2-3
2.2 Inspection before Turning ON the Power................................ 2-3
2.2 Turning ON the Power and Self-Check ................................. . 2-5
3. QUALITY CONTROL ............................................................ 2-8
4. PROCEDURES IN EACH ANALYSIS MODE ............................... 2-9
4.1 Whole Blood (WB) Mode.................................................. 2-9
4.2 Pre-Diluted (PD) Mode....................................................2-16
5. DISPLAY AND PRINTING OF ANALYSIS RESULT ....................2-24
5.1 Display of Analysis Result................................................2-24
5.2 Printing of Analysis Result ...............................................2-26
5.3 Output of Analysis Result to Host Computer...........................2-27
6. LIMITATIONS....................................................................2-28
6.1 Cell Count Parameters.....................................................2-28
6.2 Limitation of Hemoglobin.................................................2-29
7. EXPECTED RESULTS..........................................................2-30
8. STOPPING THE PNEUMATIC UNIT .......................................2-31
9. EXECUTION OF SHUTDOWN ...............................................2-32
9.1 Shutdown Procedure ......................................................2-32
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-1
1 . INTRODUCTION
This instrument works in two analysis modes: whole blood mode and pre-diluted mode.
This chapter describes the general operation procedures from instrument start-up to
shutdown, with the procedures in respective analysis modes.
1.1 Overview of Analysis Modes
• Whole blood mode
This is the mode of analyzing collected blood sample in the whole blood status. The tube
cap is opened and the sample is aspirated through the sample probe one after another.
• Pre-diluted mode
This mode is used in analyzing a minute amount of child's blood, for instance, collected
from the earlobe or fingertip. In this mode, blood sample diluted into 1:26 before
analysis is used. The sample aspiration procedure is the same as in the whole blood
mode.
NOTE: • In the pre-diluted mode, particle distribution curve and particle
distribution analysis data are not output, and the output is confined to
only the CBC8 parameter.
SAMPLE ANALYSIS
2-2 Sysmex KX-21N Operator’s Manual -- October 1999
1.2 Analysis Procedure Flow Chart
Shown below is the Flow Chart for the operation procedure with pages to refer to.
Inspection before Turning ON
the Power
Turning ON the Power and
Self-Check
Execution of Quality Control
Display and Printing of
Analysis Result
Execution of Shutdown
Turning OFF the Power
Page 2-3
Page 2-5
Page 2-8
Whole Blood Mode
Analysis
Pre-Diluted Mode
Analysis
Page 2-16Page 2-9
Page 2-24
Page 2-32
Table 2-1-1: Analysis Procedure Flow Chart
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-3
2 . START-UP PROCEDURE
2.1 Inspection before Turning ON the Power
1 . Inspection of reagents
Check to see that the reagents needed for the number of the samples to be processed
for the day are available. If the number available is such as might become short during
the day, make ready the reagents for use in replenishment. When reagents run out
during analysis, the instrument will automatically come to a stop. Replenish the
reagent that gave an error. Until replenishment is completed, analysis cannot be
resumed. The number of samples that can be analyzed with one pack of reagent is
listed below:
• Number of the samples that can be analyzed with one pack of reagent
CELLPACK: Approx. 600 samples/20 L (cubitainer)
STROMATOLYSER-WH: Approx. 470 samples/500 mL (bottle)
(The above values are the result of continuous analyses performed in one day in the
whole blood mode. Depending on the use conditions of the instrument, the result
may differ.)
• Replenishing reagent
• Make ready a new reagent and make sure that it has not passed its expiration
date. (For detail, refer to Chapter 4, Section 8: SUPPLIES REPLACEMENT.)
• Use a reagent that has been left at room temperature (15 - 30°C) for
more than 24 hours.
• If CELLPACK that has just arrived is used, "Background Error" may
occur.
• After replenishing a reagent, make sure that its background count is low
before starting sample analysis.
• As to a reagent that may have frozen, handle it in accordance with the
precautions stated on the Package Insert. Otherwise, there is a
possibility that proper analysis cannot be performed.
• When replacing the reagent container, take care not to have dust
adhere to the cubitainer spout kit.
• After unpacking, take care to prevent entry of dust, dirt, bacteria, etc.
which could impair proper analysis.
CELLPACK 20 L
STROMATOLYSER-WH 500 mL
60 days
90 days
Table 2-2-1: Expiration After Opening the Seal
CAUTION
SAMPLE ANALYSIS
2-4 Sysmex KX-21N Operator’s Manual -- October 1999
• We recommend preparing "Reagent Replenishment Record" in which to enter date
of replenishment, name of reagent, reagent lot No., expiration date, name of person
who replenished. Such record would come handy.
2 . Inspection of the instrument
Inspect the connection of tubings and cords to see that there are no broken tubes and
the power cord is properly plugged in the outlet.
3 . Inspection of waste
If waste is found to have collected in the trap chamber on the left side of the unit and
the waste tank (when provided), discard the waste.
4 . Inspection of printer paper
Open the front cover and check if printer paper needed for processing the samples for
the day is available.
Figure 2-2-1: Inspection of Printer Paper (Built-in Printer)
CAUTION: • Use the printer paper specified by Sysmex. Avoid using print paper
that has its end fixed to the core. Such paper can cause failure.
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-5
2.2 Turning ON the Power and Self-Check
Turn ON the power switch on the right side of the unit. Self-check, auto rinse, and
background check will be automatically performed, and the "Ready" (ready for analysis) will
appear.
1 . Turn ON the power switch
(1) The initial display appears on the LCD screen. The program version (Example: [00-
01]) appears at the right lower area of the screen.
Sysmex KX-21N
[00-01]
Figure 2-2-2: Initial Display
(2) Next, the instrument makes self-check of motor operation, scheduled maintenance
items, etc. The LCD screen displays "Please wait." during this period.
Please wait.
Figure 2-2-3: LCD Screen during Self-check
SAMPLE ANALYSIS
2-6 Sysmex KX-21N Operator’s Manual -- October 1999
CAUTION: • When self-check reveals any error, an error message will appear on the
LCD screen. In this case, turn OFF the power once, then turn it ON
again. If the error still occurs, contact Sysmex service representative.
• To ensure optimum operation of the instrument, service counters are
provided for the components which require scheduled maintenance. If
upon the power turn-on, the counter is found exceeding the
predetermined times, the screen advising scheduled maintenance is
displayed. When the Scheduled Maintenance screen appears, press
[C] key to stop the alarm sound, then perform maintenance operation
by following the instructions on the screen.
For detail, refer to Chapter 4: INSTRUMENT MAINTENANCE AND
SUPPLIES REPLACEMENT.
(3) When self-check is normally completed, auto rinse and background check are
performed.
*Auto Rinse*
Please wait.
Figure 2-2-4: LCD Screen during Auto Rinse
NOTE: • Auto rinse is repeated 3 - 5 times. If the background count of any
parameter exceeds tolerance after rinsing a maximum of 5 times, the
message "Background Error" is displayed and the alarm sounds. In this
case, press [HELP] key to stop the alarm and display the Action
Message screen. In accordance with the Action Message screen, take
an appropriate action.
(Refer to Chapter 7: TROUBLESHOOTING.)
• Permissible background counts
WBC 0.3 [×103
/µL] or less
RBC 0.02 [×106
/µL] or less
HGB 0.1 [g/dL] or less
PLT 10 [×103
/µL] or less
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2-7
2 . Confirming the "Ready"
When auto rinse and background check are normally completed, the buzzer (single
beep) sounds briefly and "Ready" is displayed. The LCD screen displays the result of
background check (sample No. "0").
31/12 10:20No.0 WB
No.1
PLT 0 P-LCR 0.0
MCHC 0.0 MPV 0.0
MCH 0.0 PDW 0.0
MCV 0.0 RDW-CV 0.0
HCT 0.0 RDW-SD 0.0
HGB 0.0 NEUT% 0.0 0.0
RBC 0.00 MXD% 0.0 0.0
WBC 0.0 LYM% 0.0 0.0
1:M.Discri. 2:Output
Ready
Figure 2-2-5: Ready Status
NOTE: • When the power is on, the next sample No. is displayed "1."
SAMPLE ANALYSIS
2-8 Sysmex KX-21N Operator’s Manual -- October 1999
3 . QUALITY CONTROL
Quality control is of great importance for obtaining highly reliable data over a long period of
time, as is the constant monitoring of the instrument for preventing troubles or for early
detection of problems. Before starting sample analysis, analyze control blood
(EIGHTCHECK-3WP) using X control or L-J control program. The analysis mode used in
analyzing control blood is described below.
• Analysis mode to analyze a control blood
Control blood is analyzed in the QC analysis mode. For analysis procedure and
examination of analysis result, refer to Chapter 5: QUALITY CONTROL.
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-9
4 . PROCEDURES IN EACH ANALYSIS MODE
With this instrument, sample mixing, cap removal, and tube setting are performed manually.
Sample analysis can be executed when the instrument is in the Ready status.
4.1 Whole Blood (WB) Mode
Samples are processed in the following steps:
1. Collecting and preparing samples
2. Selecting whole blood mode
3. Inputting sample No.
4. Analyzing samples
1 . Collecting and preparing samples
A specified amount of sample, corresponding to the amount of EDTA anticoagulant, is
collected from the vein.
• Some anticoagulants alter test results due to their effects on RBC
hemolysis or platelet agglutination. As anticoagulant, use EDTA-2K,
EDTA-3K, or EDTA-2Na.
• In the case of refrigerated blood, leave the blood taken from the
refrigerator for 30 minutes until it equilibrated to room temperature.
• When the reagent might have frozen, handle it according to the
precautions stated on the Package Insert of each reagent. Otherwise,
improper analysis may result.
Tubes up to 80 mm in height should be used. The volume of sample that can be
aspirated is as follows:
Volume of sample aspirated Approx. 50 µL
CAUTION
SAMPLE ANALYSIS
2-10 Sysmex KX-21N Operator’s Manual -- October 1999
2 . Selecting whole blood mode
When the line on the side of the system status area on the LCD screen is " ", the
pre-diluted (PD) mode is in use for analysis, so change it over to the whole blood
(WB) mode by the following procedure:
(1) Confirm the Ready status.
(2) Press [MODE] key to display the Change Mode screen.
*Change Mode*
Whole Blood(WB) Pre-Diluted(PD)Pre-Diluted(PD)
Change mode with [ ]or[ ]. Press [ENTER] to Set.
Figure 2-4-1: Change Mode Screen
(3) Press [ ] or [ ] key to select "Whole Blood (WB)."
*Change Mode*
Whole Blood(WB) Pre-Diluted(PD)
Change mode with [ ]or[ ]. Press [ENTER] to Set.
Figure 2-4-2: Selecting WB Mode
(4) Press [ENTER] key to changeover the analysis mode and return to the Analysis
screen.
NOTE: • The analysis mode selected here is maintained after completion of
analysis, until it is switched to the other analysis mode.
• At the time of turning-on the power, the system is in the whole blood
mode.
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-11
3 . Inputting sample No.
The sample No. can be input by the following two methods.
• Input from the panel keyboard
• Input using the hand held barcode reader (option)
NOTE: • The sample number is set by the incremented value for each analysis.
Input the sample number when changing.
• Input from the panel keyboard
(1) Press [SAMPLE No.] key in the Ready status. In the system status area on the LCD
screen, the next sample No. turns to the reverse display and the system is waiting for
Sample No. input (in the "Not Ready" status).
No.123456789012345
Not Ready
Figure 2-4-3: Waiting for Sample No. input
(2) The cursor appears under sample No. Input sample No. using the numeric keys.
[Example] Input of sample No. 5
Press [5] key on the numeric keys.
CAUTION: • Sample No. "0" (zero) is treated as a special sample number.
1) Judgment on patient limit is not made for analysis data.
2) Analysis data is not stored.
3) Data is not transferred to the host computer.
4) Sample No. is not incremented.
5) Judgment on abnormal histogram is not made.
6) When one attempts to make analysis with the sample No. of "0"
(zero), the buzzer sounds during sample aspiration.
NOTE: • When entering the sample No. (on the screen of the previous page),
press [C] key first. This will clear the entire sample No. Then, enter a
new sample No.
• In the course of entering the sample No., each time you press [C] key,
one character disappears with the cursor moving to the left.
• A sample No. of a maximum of 15 digits, comprising numerics and a
hyphen, can be used.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
SAMPLE ANALYSIS
2-12 Sysmex KX-21N Operator’s Manual -- October 1999
(3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready,
namely, ready for analysis.
NOTE: • When all sample Nos. are cleared, [ENTER] key is not accepted.
When you attempt to do so, an alarm sounds.
• In the status of waiting for sample No. input ("Not Ready"), press
[SAMPLE No.] or [SELECT] key. The screen returns to the Analysis
screen without updating sample No.
• Input using the hand held barcode reader (option)
(1) Press [SAMPLE No.] key in the Ready status. In the system status area on the LCD
screen, the next sample No. turns to the reverse display and the system is waiting for
Sample No. input (in the "Not Ready" status).
No.123456789012345
Not Ready
Figure 2-4-4: Waiting for Sample No. input
(2) Read the barcode affixed to the test tube with the hand held barcode reader.
Figure 2-4-5: Reading the Barcode
When reading has been carried out normally, the read sample number will appear.
(3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready,
namely, ready for analysis.
NOTE: • In the status of waiting for sample No. input ("Not Ready"), press
[SAMPLE No.] or [SELECT] key. The screen returns to the Analysis
screen without updating sample No.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-13
4 . Analyzing samples
• When analyzing samples, always wear rubber gloves. After
completion of work, wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can occur.
(1) Mix the sample sufficiently.
Figure 2-4-6: Mixing the Sample
(2) Remove the plug while taking care not to allow blood scatter.
Figure 2-4-7: Removing the Plug
(3) Set the tube to the sample probe, and in that condition, press the start switch.
Start Switch
Figure 2-4-8: Pressing the Start Switch
WARNING
SAMPLE ANALYSIS
2-14 Sysmex KX-21N Operator’s Manual -- October 1999
(4) The buzzer sounds two times - "beep, beep" - and when the LCD screen displays
"Analyzing," remove the tube. After that, the unit executes automatic analysis and
displays the result on the LCD screen. Then the unit turns to the Ready status,
becoming ready for analysis of the next samples.
The screens from the start to the end of analysis are as shown in the following:
(Ready)
No.123456789-12345
Ready
(Aspirating)
No.123456789-12345
Aspirating
(Analyzing)
No.123456789-12345
Analyzing
(Rinsing)
No.123456789-12345
Rinsing
(Ready)
No.123456789-12346
Ready
Figure 2-4-9: LCD Screen (in WB Mode)
• While the LCD screen is displaying "Aspirating," keep holding the tube
in the aforementioned status. If the tube is removed during its display,
correct analysis result may not be obtained.
CAUTION: • Several seconds after the buzzer sounds "beep, beep" and
"Aspirating" appears on the LCD screen, the rinse cup lowers. By that
time, remove the tube.
• To remove the tube, lower it straight down. Take care not to bend the
sample probe.
NOTE: • The sample probe is automatically rinsed, so there is no need to wipe it
clean.
CAUTION
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-15
(5) When the LCD screen displays "Ready," prepare the next samples and repeat the
procedure (1) to (4).
NOTE: • Sample No., if not changed, is automatically incremented by 1, although
"0" (zero) is not incremented.
[Example] 123 → 124
999999999999999 → 1
12-3 → 12-4
12-999 → 12-000
SAMPLE ANALYSIS
2-16 Sysmex KX-21N Operator’s Manual -- October 1999
4.2 Pre-Diluted (PD) Mode
In this mode, a sample is diluted into 1:26 before analysis. This mode is applied in analyzing
a capillary blood collected from the earlobe or fingertip. Samples are processed by the
following steps:
1. Collecting and preparing samples
2. Preparing analysis samples in PD mode (dilution of 1:26)
3. Selecting Pre-Diluted mode
4. Inputting sample No.
5. Analyzing samples
1 . Collecting and preparing samples
Dilute samples to the ratio of 1:26 using CELLPACK dispensed beforehand in
containers.
[Example]
20 µL of blood is diluted in 500 µL of CELLPACK.
• Dilute and analyze a capillary blood collected from the earlobe or
fingertip immediately to avoid possible platelet agglutination.
A correct result might not be obtained if 30 minutes are passed after
dilution.
• With a sample of blood collected from the earlobe or fingertip, blood cell
count is generally higher than normal, with lower reproducibility. If
possible, analyze the same diluted sample twice and compare the
results. When the blood collection tube containing a commercial anti-
coagulant is used, there is a possibility that RBC hemolysis or platelet
agglutination occurs depending on the types of anticoagulant, with a
consequent change in analysis result. As anti-coagulant, use EDTA-
2K, EDTA-3K, or EDTA-2Na.
Tubes up to 80 mm in height should be used. The volume of sample is as follows:
Volume of whole blood required Approx. 20 µL or more
Volume of sample aspirated Approx. 200 µL
CAUTION
Sysmex KX-21N Operator’s Manual -- Revised February 2000
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-17
2 . Preparing analysis samples in PD mode (1:26 Dilution)
(1) Clean a container such as erlenmeyer flask, beaker, etc. with CELLPACK and remove
any dirt.
(2) Using a syringe, etc., take CELLPACK into a cleaned container.
(3) Using a 500 µL transfer pipette, dispense 500 µL of CELLPACK into a micro-tube.
(4) Using a capillary tube, etc., collect 20 µL of blood and dispense it into the micro-tube.
(5) Attach the cap and mix well.
• When preparing PD-mode analysis samples, always wear rubber
gloves. After completion of work, wash hands with disinfectant. If
your hands are contaminated by blood, etc., infection of bacteria or
the like can occur.
• A 1:26 dilution sample is prone to platelet agglutination. So, analyze
the sample within 30 minutes after blood dispensing and diluting. If
diluent is dispensed in advance, evaporation and dirt mixing will result
in errors in analysis values. Therefore prepare one sample at a time.
When preparing a 1:26 dilution sample, use the tools listed below:
• Diluent (CELLPACK)
• Micro-tube (MT-40, etc.)
• Capillary tube
• A 500 µL transfer pipette
• A container, such as erlenmeyer flask or beaker
• A syringe
WARNING
CAUTION
SAMPLE ANALYSIS
2-18 Sysmex KX-21N Operator’s Manual -- October 1999
3 . Selecting Pre-Diluted mode
When the line on the side of the system status area on the LCD screen is " ", the
whole blood (WB) mode is in use for analysis, so change it over to the pre-diluted
(PD) mode by the following procedure:
(1) Confirm the Ready status.
(2) Press [MODE] key to display the Change Mode screen.
*Change Mode*
Whole Blood(WB) Pre-Diluted(PD)
Change mode with [ ]or[ ]. Press [ENTER] to Set.
Figure 2-4-10: Change Mode Screen
(3) Press [ ] or [ ] key to select "Pre-Diluted (PD)."
*Change Mode*
Whole Blood(WB) Pre-Diluted(PD)Pre-Diluted(PD)
Change mode with [ ]or[ ]. Press [ENTER] to Set.
Figure 2-4-11: Selecting PD Mode
(4) Press [ENTER] key to changeover the analysis mode and return to the Analysis
screen.
NOTE: • The analysis mode selected here is maintained after completion of
analysis, until it is switched to the other analysis mode.
• At the time of turning-on the power, the system is in the whole blood
mode.
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-19
4 . Inputting sample No.
The sample No. can be input by the following two methods.
• Input from the panel keyboard
• Input using the hand held barcode reader (option)
NOTE: • The sample number is set by the incremented value for each analysis.
Input the sample number when changing.
• Input from the panel keyboard
(1) Press [SAMPLE No.] key in the Ready status. The next Sample No. in the system
status area on the LCD screen turns to the reverse display and the system waits for
Sample No. input (in the "Not Ready" status).
No.123456789012345
Not Ready
Figure 2-4-12: Waiting for Sample No. input
(2) The cursor appears under sample No. Input sample No. using the numeric keys.
[Example] Input of Sample No. 5
Press [5] key on the numeric keys.
CAUTION: • Sample No. "0" (zero) is treated as a special sample number.
1) Judgment on patient limit is not made for analysis data.
2) Analysis data is not stored.
3) Data is not transferred to the host computer.
4) Sample No. is not incremented.
5) Judgment on abnormal histogram is not made.
6) When one attempts to make analysis with the sample No. of "0"
(zero), the buzzer sounds during sample aspiration.
NOTE: • When entering the sample No. (on the screen of the previous page),
press [C] key first. This will clear the entire sample No. Then, enter a
new sample No.
• In the course of entering the sample No., each time you press [C] key,
one character disappears with the cursor moving to the left.
• A sample No. of a maximum of 15 digits, comprising numerics and a
hyphen, can be used.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
SAMPLE ANALYSIS
2-20 Sysmex KX-21N Operator’s Manual -- October 1999
(3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready,
namely, ready for analysis.
NOTE: • When all sample Nos. are cleared, [ENTER] key is not accepted.
When you attempt to do so, an alarm sounds.
• In the status of waiting for sample No. input ("Not Ready"), press
[SAMPLE No.] or [SELECT] key. The screen returns to the Analysis
screen without updating sample No.
• Input using the hand held barcode reader (option)
(1) Press [SAMPLE No.] key in the Ready status. In the system status area on the LCD
screen, the next sample No. turns to the reverse display and the system is waiting for
Sample No. input (in the "Not Ready" status).
No.123456789012345
Not Ready
Figure 2-4-13: Waiting for Sample No. input
(2) Read the barcode affixed to the test tube with the hand held barcode reader.
Figure 2-4-14: Reading the Barcode
When reading has been carried out normally, the read sample number will appear.
(3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready,
namely, ready for analysis.
NOTE: • In the status of waiting for sample No. input ("Not Ready"), press
[SAMPLE No.] or [SELECT] key. The screen returns to the Analysis
screen without updating sample No.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-21
5 . Analyzing samples
• When analyzing samples, always wear rubber gloves, and after
completion of work, wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can occur.
(1) Mix the sample sufficiently.
Figure 2-4-15: Mixing the Sample
(2) Remove the plug while taking care not to allow blood scatter.
Figure 2-4-16: Removing the Plug
(3) Set the micro-tube to the sample probe, and in that condition, press the start switch.
Start Switch
Figure 2-4-17: Pressing the Start Switch
WARNING
SAMPLE ANALYSIS
2-22 Sysmex KX-21N Operator’s Manual -- October 1999
(4) The buzzer sounds two times - "beep, beep" - and when the LCD screen displays
"Analyzing," remove the micro-tube. After that, the unit executes automatic analysis
and displays the result on the LCD screen. Then the unit turns to the Ready status,
becoming ready for analysis of the next samples.
The screens from the start to the end of analysis are as shown in the following:
(Ready)
No.123456789-12345
Ready
(Aspirating)
No.123456789-12345
Aspirating
(Analyzing)
No.123456789-12345
Analyzing
(Rinsing)
No.123456789-12345
Rinsing
(Ready)
No.123456789-12346
Ready
Figure 2-4-18: LCD Screen (in PD Mode)
• While the LCD screen is displaying "Aspirating," keep holding the
micro-tube in the aforementioned status. If the micro-tube is removed
during its display, correct analysis result may not be obtained.
CAUTION: • Several seconds after the buzzer sounds "beep, beep" and
"Aspirating" appears on the LCD screen, the rinse cup lowers. By that
time, remove the micro-tube.
• To remove the micro-tube, lower it straight down. Take care not to
bend the sample probe.
NOTE: • The sample probe is automatically rinsed, so there is no need to wipe it
clean.
CAUTION
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-23
(5) When the LCD screen displays "Ready," prepare a next sample and repeat the
procedure (1) to (4).
NOTE: • Sample No., if not changed, is automatically incremented by 1, although
"0" (zero) is not incremented.
[Example] 123 → 124
999999999999999 → 1
12-3 → 12-4
12-999 → 12-000
SAMPLE ANALYSIS
2-24 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
5 . DISPLAY AND PRINTING OF ANALYSIS RESULT
5.1 Display of Analysis Result
The result of each analysis is displayed on the LCD screen.
The display screen of analysis result consists of five pages, and pages are turned over by
using [ ] or [ ] key.
For the contents of display, refer to Chapter 3, Section 2.1: Display of Analysis Result.
Examples of display (For the Whole Blood mode)
31/12 10:59No.123456789-12345 WB
No.123456789-12346
PLT 180 P-LCR - 9.5
MCHC + 44.8 MPV 9.3
MCH 37.0 PDW - 7.9
MCV - 82.6 RDW-CV 20.5
HCT 32.8 RDW-SD - 25.6
HGB 14.7 NEUT% 49.2 3.5
RBC 3.97 MXD% 19.6 1.4
WBC 7.1 LYM% 31.2 2.2
31/12 10:59No.123456789-12345 WB
No.123456789-12346
PLT 180 ×103
/µL
MCHC + 44.8 g/dL
MCH 37.0 pg
MCV - 82.6 fL
HCT 32.8 %
HGB 14.7 g/dL
RBC 3.97 ×106
/µL
WBC 7.1 ×103
/µL
31/12 10:59No.123456789-12345 WB
No.123456789-12346
P-LCR - 9.5 %
MPV 9.3 fL
PDW - 7.9 fL
RDW-CV 20.5 %
RDW-SD - 25.6 fL
NEUT% 49.2 % 3.5
MXD% 19.6 % 1.4
LYM% 31.2 % 2.2
31/12 10:59No.123456789-12345 WB
No.123456789-12346
WBC
RBC
PLT
31/12 10:59No.123456789-12345 WB
No.123456789-12346
WBC
RBC
PLT
PLT 180 ×103
/µL
MCHC + 44.8 g/dL
MCH 37.0 pg
MCV - 82.6 fL
HCT 32.8 %
HGB 14.7 g/dL
RBC 3.97 ×106
/µL
WBC 7.1 ×103
/µL
P-LCR - 9.5 %
MPV 9.3 fL
PDW - 7.9 fL
RDW-CV 20.5 %
RDW-SD - 25.6 fL
NEUT% 49.2 % 3.5
MXD% 19.6 % 1.4
LYM% 31.2 % 2.2
P1. All Analysis Data Display Screen P2. CBC8 Parameter & Patient Limit Graph
Display Screen
P3. Calculation Parameter & Patient Limit
Graph Display Screen
P5. CBC8 Parameter & Particle Distribution
Display Screen
P4. Calculation Parameter & Particle Distribution
Display Screen
Ready
1:M.Discri. 2:Output
Ready
1:M.Discri. 2:Output
Ready
1:M.Discri. 2:Output
Ready
1:M.Discri. 2:Output
Ready
1:M.Discri. 2:Output
Figure 2-5-1: Analysis Result Display Screen
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2-25
5.2 Printing of Analysis Result
Analysis result can be printed out on the built-in or the external printer. (The external printer
is an option)
For the contents of the print and the printing procedure, refer to Chapter 3, Section 2.3:
External Output.
Examples of printing with the Built-in Printer
WBC
[fL]
RBC
[fL]
PLT
[fL]
[Type 1] [Type 2] [Type 3]
No. 123456789-12345
Date 31/10/1999
Time 10:02
Mode WB [W][R][P]
WBC 7.3 ×103
/µL
RBC 4.52 ×106
/µL
HGB 14.8 g/dL
HCT 36.2 %
MCV 80.1 fL
MCH 32.7 Pg
MCHC 40.9 g/dL
PLT 206 ×103
/µL
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103
/µL
MXD# 1.0 ×103
/µL
NEUT# 4.3 ×103
/µL
RDW-SD 8.3 fL
RDW-CV 15.0 %
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
No. 123456789-12345
Date 31/10/1999
Time 10:02
Mode WB [W][R][P]
WBC 7.3 ×103
/µL
RBC 4.52 ×106
/µL
HGB 14.8 g/dL
HCT 36.2 %
MCV 80.1 fL
MCH 32.7 Pg
MCHC 40.9 g/dL
PLT 206 ×103
/µL
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103
/µL
MXD# 1.0 ×103
/µL
NEUT# 4.3 ×103
/µL
RDW-SD 8.3 fL
RDW-CV 15.0 %
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
No. 123456789-12345
Date 31/10/1999
Time 10:02
Mode WB [W][R][P]
WBC 7.3 ×103
/µL
RBC 4.52 ×106
/µL
HGB 14.8 g/dL
HCT 36.2 %
MCV 80.1 fL
MCH 32.7 Pg
MCHC 40.9 g/dL
PLT 206 ×103
/µL
Figure 2-5-2: Printing of Analysis Result (Built-in Printer)
NOTE: • One print format can be selected from among Types 1, 2, and 3.
For the selecting procedure, refer to Chapter 10, Section 7.3: IP Output
Settings.
SAMPLE ANALYSIS
2-26 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
Examples of printing with the Graphic Printer
Sample No.:123456789-12345 31/10/1999 16:40
Mode:WB Manual Ana:[W][R][P]
[ERROR]
WBC 7.3 [×103
/µL]
RBC 4.52 [×106
/µL]
HGB 14.8 [g/dL]
HCT 36.2 [%]
MCV 80.1 [fL]
MCH 32.7 [Pg]
MCHC 40.9 [g/dL]
PLT 206 [×103
/µL]
LYM% 27.2 [%]
MXD% 13.4 [%]
NEUT% 59.4 [%]
LYM# 2.0 [×103
/µL]
MXD# 1.0 [×103
/µL]
NEUT# 4.3 [×103
/µL]
RDW-SD 8.3 [fL]
RDW-CV 15.0 [%]
PDW 8.3 [fL]
MPV 9.1 [fL]
P-LCR 14.8 [%]
PLT
RBC
WBC
Figure 2-5-3: Printing of Analysis Result (Graphic Printer)
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2-27
Examples of printing with the Data Printer
HEMATOLOGY
Doctor
Age
Data
Sample No.
WBC
×103/µL
RBC
×106/µL
HGB
g/dL
HCT
%
MCV
fL
MCH
pg
MCHC
g/dL
PLT
Myelo-
blast
×103/µL
W-SCR
%
W-MCR
%
W-LCR
%
W-SCC
×103/µL
W-MCC
×103/µL
W-LCC
×103/µL
RDW-SD
fL
MPV
fL
W-SCR WBC-Small Cell Ratio
10/12/1999
123456789012345
Retic
Pro
Myelo
Meta
Neutro
Stab
Seg
Eosino
Baso
Mono
Lymph
5.6+
3.58
8.0
34.1
80.1
M
F
Carte No.
Name
PRINT TICKET No.22
W-MCR WBC-Middle Cell Ratio
W-LCR WBC-Large Cell Ratio
W-SCC WBC-Small Cell Count
W-MCC WBC-Middle Cell Count
W-LCC WBC-Large Cell Count
RDW-CV RBC Distrib. Width-CV
PDW PLT Distrib. Width
MPV Mean Platelet Vol
P-LCR PLT-Large Cell Ratio
32.7
40.9
206
28.3
18.8
52.9
1.6
1.0
3.0
68.5
10.0
Figure 2-5-4: Printing of Analysis Result (Data Printer)
5.3 Output of Analysis Result to Host Computer
The analysis result can be output to the host computer.
For the output procedure to the host computer, refer to Chapter 3, Section 2.3: External
Output.
SAMPLE ANALYSIS
2-28 Sysmex KX-21N Operator’s Manual -- October 1999
6 . LIMITATIONS
6.1 Cell Count Parameters
Some abnormal samples may give incorrect results by automated cell counting methods. The
following table shows examples of specific specimens that could cause errors.
Parameter Specimen Error Possible Indication of Error
WBC Cold Agglutinin
Platelet aggregation
Erythroblastosis
Nucleated RBC
Cryoglobulins
(+)
(+)
(+)
(+)
(+)
↑MCV, ↓HCT, red cell clumping on smear
Platelet aggregates on smear
Erythroblasts on smear
NRBC on smear
RBC Cold Agglutinin
Severe Microcytosis
Fragmented RBC
Leukocytosis
(>100,000/µL)
(-)
(-)
(-)
(+)
↑MCV, ↓HCT, red cell clumping on smear
Elevation of WBC
HGB Leukocytosis
(>100,000/µL)
Lipemia
Abnormal Protein
(+)
(+)
(+)
Elevation of WBC
↑MCHC, “milky” appearance of plasma
↑MCHC, Lysed Hgb/WBC sample turns
cloudy
HCT Cold Agglutinin
Leukocytosis
(>100,000/µL)
Abnormal Red Cell Fragility
Spherocytosis
(-)
(+)
(?)
(?)
↑MCV, ↓HCT, red cell clumping on smear
Elevation of WBC
↓MCV, spherocytes on smear
PLT Pseudothrombocytopenia
Platelet Aggregation
Increased Microcytosis
Megalocytic Platelets
(-)
(-)
(+)
(-)
Platelet Satellitism on smear
Platelet Aggregation on smear
↓MCV
(+): Instrument count is affected by an increase in the result.
(-): Instrument count is affected by a decrease in the result.
(?): Instrument count is affected by either an increase or decrease in the result which is
sample dependent.
CAUTION: • WBC results may be elevated erroneously due to unlysed red cells in
patients with hemoglobinopathies, severe liver disease or in neonates.
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-29
6.2 Limitation of Hemoglobin
1. Hemoglobin measurements may be falsely elevated due to the influences of abnormal
samples including leukocytosis above 100,000/µL, lipemia or abnormal proteins in
blood plasma. The affect of lipemia and abnormal proteins may be removed by plasma
replacement or plasma blank procedures.
2. Performance specifications for hemoglobin results are assured only when instrument
environment and sample requirements are observed.
3. The hemoglobin method available for this analyzer cannot detect sulfhemoglobin,
verdohemoglobin choleglobin or other unusual degradation products of hemoglobin.
SAMPLE ANALYSIS
2-30 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
7 . EXPECTED RESULTS
Reference intervals (normal population reference ranges) were developed for the KX-21N
using normal individuals. The ranges for each parameter --- WBC, RBC, Hemoglobin,
Hematocrit, MCV, MCH, MCHC, RDW-CV, RDW-SD, Platelet, MPV, Lym% and #,
Mxd% and #, and Neut% and # were determined and displayed in Table 1-16-1.
Parameter Range for
Females n=117
Range for Males
n = 1 2 4
WBC 3.1 - 10.3 2.6 - 8.8
RBC 3.2 - 4.6 3.6 - 5.3
Hgb 9.9 -13.6 11.3 - 15.7
Hct 30.2 - 42.3 32.6 - 47.5
MCV 78.6 - 102.2 80.3 - 103.4
MCH 25.2 - 34.7 26 - 34.4
MCHC 31.3 - 35.4 31.8 - 36.3
Plt 128 - 434 134 - 377
Lym% 15 - 45.8 17.5 - 47.9
Mxd% 1.3 - 25.9 1.9 - 24.6
Neut% 43.7 - 77.1 38.3 - 69
Lym# 0.9 - 2.8 0.8 - 2.7
Mxd# 0.1 - 1.6 0.1 - 1.5
Neut# 1.6 - 6.9 1.2 - 5.3
RDW-CV 10.6 - 15.7 10.8 - 14.9
RDW-SD 35.3 - 48.9 33.4 - 49.2
MPV 8.5 - 12.4 8.1 - 12.4
Table 2-7-1: Normal Population Reference Ranges
NOTE: • The age range for females was 17 - 66 years with a mean age of 33.4.
• The age range for males was 17 - 72 years with a mean age of 42.2.
Sysmex recommends that each laboratory establish its own expected reference intervals
based upon the laboratory’s patient population encountered during daily operation. Expected
reference intervals may vary due to differences in sex, age, diet, fluid intake, geographic
location, etc. The NCCLS Document C28A1, “How to Define and Determine Reference
Intervals in the Clinical Laboratory; Approved Guideline”. This document contains
guidelines for determining reference values and intervals for quantitative clinical laboratory
test.
1 NCCLS, 771 East Lancaster Avenue, Villanova, PA 19085, USA.
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-31
8 . STOPPING THE PNEUMATIC UNIT
The KX-21N, when left non-operating for 15 minutes, automatically stops the pneumatic
unit. It is also possible to manually stop the pneumatic unit using the following procedures:
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "00: PU Sleep."
*SELECT*
1:Stored Data
2:Quality Control
3:Calibration
4:Replace Lyse
5:Auto Rinse
6:Settings
7:Maintenance
8:Periph. Settings
00:PU Sleep
Figure 2-8-1: Select Menu Screen
(3) Press [ENTER] key. This stops the pneumatic unit.
NOTE: • Press the start switch to return to the ready status.
SAMPLE ANALYSIS
2-32 Sysmex KX-21N Operator’s Manual -- October 1999
9 . EXECUTION OF SHUTDOWN
When analyses of all samples are finished, execute shutdown before turning the power off.
By executing shutdown, the TD chamber and diluted sample line are cleaned. Execute
shutdown after the day's work is finished, and also when this instrument is used
continuously, shut it down at least once in 24 hours.
CAUTION: • If the power is turned OFF before executing shutdown, failures could
occur, such as fluid dripping from the rinse cup and crystals forming
around the rinse cup.
9.1 Shutdown Procedure
(1) Press [SHUTDOWN] key in the Ready status. The Shutdown screen appears.
3:Cancel
*Shutdown*
Aspirate CELLCLEAN.
It will take approx. 5 minutes.
Ready
Figure 2-9-1: Shutdown Screen
NOTE: • When [3] key is pressed, shutdown is canceled and the Analysis
screen returns.
SAMPLE ANALYSIS
Sysmex KX-21N Operator’s Manual -- October 1999 2-33
(2) When executing shutdown, set CELLCLEAN to the sample probe and press the start
switch in that status. While "Aspirating" is being displayed on the screen, keep
holding CELLCLEAN in the same status.
Start Switch
Figure 2-9-2: Pressing the Start Switch
• Because CELLCLEAN is a strong alkaline detergent, take care not to
have it adhere to the skin or clothes. If the skin or clothes should
come in touch with it, flush it away using plenty of water. Otherwise,
it can damage the skin or clothes.
NOTE: • Once shutdown is executed, it cannot be canceled until it is completed.
(3) When the buzzer sounds two times - beep, beep- , informing the completion of
aspiration, remove CELLCLEAN from the sample probe.
After that, shutdown is executed automatically.
*Shutdown*
Please wait.
Rinsing
Figure 2-9-3: Shutdown Execution Screen
CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to bend
the sample probe.
WARNING
SAMPLE ANALYSIS
2-34 Sysmex KX-21N Operator’s Manual -- October 1999
(4) When shutdown is finished and the following message is displayed, turn off the power
switch on the right side of the unit.
1:Re-boot
Shut-down sequence was completed.
Turn OFF the power.
*Shutdown*
Figure 2-9-4: Shutdown Completion Message Screen
NOTE: • Shutdown will take approximately 5 minutes.
• When the [1] key is pressed, the unit will restart.
Sysmex KX-21N Operator’s Manual -- October 1999
CHAPTER 3 DISPLAY AND PROCESSING
OF ANALYSIS RESULTS
1. INTRODUCTION ................................................................. 3-1
2. PROCESSING LATEST SAMPLES ...........................................3-2
2.1 Display of Analysis Result.................................................3-2
2.2 Manual Discrimination......................................................3-7
2.3 External Output............................................................ 3-11
3. PROCESSING STORED DATA .............................................. 3-14
3.1 Executing and Quitting Stored Data Processing Program ............ 3-14
3.2 Stored Data Screen........................................................ 3-15
3.3 Deletion..................................................................... 3-20
3.4 External Output............................................................ 3-21
3.5 Correcting a Sample Number............................................ 3-23
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 3-1
1 . INTRODUCTION
This instrument displays analysis result and information that assists in breaking down
analysis result and outputs such data to external devices. This chapter describes the
processing of analysis result, such as displaying latest or stored data on the screen or
outputting them to external devices. The gist of the contents is as follows:
Processing of Latest Samples
When analysis is finished, analysis result is displayed in three kinds of screens. The display
contents of Analysis Result screen, what they mean, and how to process them are explained
here.
Processing of Stored Data
The analysis data stored in the instrument can be read at anytime. Description is made on the
display contents of stored data, what they mean, deletion by marking, and output to external
devices.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-2 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
2 . PROCESSING LATEST SAMPLES
2.1 Display of Analysis Result
The analysis result is displayed in the Analysis Result Display Area on the LCD screen. In
the Analysis Result Display Area, the analysis result is displayed each time a new sample is
analyzed. When the analysis result is displayed, the menu display area displays the menu of
"1: M. Discri." and "2: Output," which can each be executed using the numeric keys.
The Analysis screen consists of five pages that differ from each other in "Analysis Result
Display Area."
Use [ ] key or [ ] key to change over pages.
P1. All Analysis Data Display Screen
P2. CBC8 Parameter & Patient Limit Graph
Display Screen
P3. Calculation Parameter & Patient Limit
Graph Display Screen
P5. CBC8 Parameter & Particle Distribution
Display Screen
P4. Calculation Parameter & Particle
Distribution Display Screen
Figure 3-2-1: Page Selection in the Analysis Screen
P1. All Analysis Data Display Screen
31/12 10:59No.123456789-12345 WB
No.123456789-12346
PLT 180 P-LCR - 9.5
MCHC + 44.8 MPV 9.3
MCH 37.0 PDW - 7.9
MCV - 82.6 RDW-CV 20.5
HCT 32.8 RDW-SD - 25.6
HGB 14.7 NEUT% 49.2 3.5
RBC 3.97 MXD% 19.6 1.4
WBC 7.1 LYM% 31.2 2.2
Ready
1:M.Discri. 2:Output
Latest Sample No.
Mode Indication
Menu Display Area
Analysis Result Display Area
Date/Time Analyzed
System Status Display Area
Figure 3-2-2: All Analysis Data Display Screen
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 3-3
P2. CBC8 Parameter & Patient Limit Graph Display Screen
31/12 10:59No.123456789-12345 WB
No.123456789-12346
PLT 180 ×103
/µL
MCHC + 44.8 g/dL
MCH 37.0 pg
MCV - 82.6 fL
HCT 32.8 %
HGB 14.7 g/dL
RBC 3.97 ×106
/µL
WBC 7.1 ×103
/µL
1:M.Discri. 2:Output
Ready
Patient Limit Graph
Latest Sample No.
Mode Indication
Date/Time Analyzed
Figure 3-2-3: CBC8 Parameter & Patient Limit Graph Display Screen
P3. Calculation Parameter & Patient Limit Graph Display Screen
NOTE: • When analysis is made in the pre-diluted mode, particle distribution
analysis parameters are displayed in "- - -. -." The particle distribution
curve is not displayed.
31/12 10:59No.123456789-12345 WB
No.123456789-12346
P-LCR - 9.5 %
MPV 9.3 fL
PDW - 7.9 fL
RDW-CV 20.5 %
RDW-SD - 25.6 fL
NEUT% 49.2 % 3.5
MXD% 19.6 % 1.4
LYM% 31.2 % 2.2
1:M.Discri. 2:Output
Ready
Latest Sample No.
Mode Indication
Date/Time Analyzed
Patient Limit Graph
Figure 3-2-4: Calculation Parameter & Patient Limit Graph Display Screen
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-4 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
P4. Calculation Parameter & Particle Distribution Display Screen
31/12 10:59No.123456789-12345 WB
No.123456789-12346
WBC
RBC
PLT
P-LCR - 9.5 %
MPV 9.3 fL
PDW - 7.9 fL
RDW-CV 20.5 %
RDW-SD - 25.6 fL
NEUT% 49.2 % 3.5
MXD% 19.6 % 1.4
LYM% 31.2 % 2.2
1:M.Discri. 2:Output
Ready
WBC Particle
Distribution Chart
RBC Particle
Distribution Chart
PLT Particle
Distribution Chart
Latest Sample No.
Mode Indication
Date/Time Analyzed
Figure 3-2-5: Calculation Parameter & Particle Distribution Display Screen
P5. CBC8 Parameter & Particle Distribution Display Screen
31/12 10:59No.123456789-12345 WB
No.123456789-12346
WBC
RBC
PLT
PLT 180 ×103
/µL
MCHC + 44.8 g/dL
MCH 37.0 pg
MCV - 82.6 fL
HCT 32.8 %
HGB 14.7 g/dL
RBC 3.97 ×106
/µL
WBC 7.1 ×103
/µL
1:M.Discri. 2:Output
Ready
Latest Sample No.
Mode Indication
Date/Time Analyzed
WBC Particle
Distribution Chart
RBC Particle
Distribution Chart
PLT Particle
Distribution Chart
Figure 3-2-6: CBC8 Parameter & Particle Distribution Display Screen
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 3-5
Display Contents of Analysis Data Display Screens
1 ) System Status Display Area
This area displays the status of the instrument. For details, refer to Chapter 1, Section
8.1: Contents of Display.
2 ) Latest Sample No.
The latest sample No. is displayed.
3 ) Mode Indication
The latest sample's analysis mode is displayed.
The whole blood mode is displayed as "WB" and the pre-diluted mode as "PD."
4 ) Date/Time Analyzed
Date and time when analysis result was obtained are displayed.
5 ) Analysis Data
The analysis data of the following 17 parameters or part of them are displayed
depending on the screen:
Analysis parameters (8): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT
Calculation parameters (9): LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#,
RDW-SD, RDW-CV, MPV
The marks to the left of analysis data indicate the following:
1. ! : The data is out of the linearity limit.
2. * : The data is low in reliability because of a histogram error.
3. + : The data exceeds the upper Mark Limits.
- : The data exceeds the lower Mark Limits.
NOTE: • The marks are added with the priority order of 1, 2, and 3.
• The Mark Limits with "+" and "-" can be set by the customer. For
details, refer to Chapter 10, Section 4: Patient Limit.
When an analysis error, etc. has caused errors in analysis data, the marks below are
attached to the affected data:
1. + + +. +: When data has exceeded the display range.
2. * * *. *: When data could not be calculated due to instrument failure.
3. - - -. -: When data could not be calculated due to data error.
NOTE: • When analysis is made in the pre-diluted mode, particle distribution
analysis parameters are displayed in "- - -. -."
Sysmex KX-21N Operator’s Manual -- Revised May 2003 N.A.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-6 Sysmex KX-21N Operator’s Manual -- October 1999
When an error is found in particle distribution, a histogram error flag among the
following is displayed:
1. WL: Relative frequency of WBC-LD has exceeded the range.
2. WU: Relative frequency of WBC-UD has exceeded the range.
3. T1: T1 discriminator position cannot be determined.
4. T2: T2 discriminator position cannot be determined.
5. F1: Relative frequency of T1 has exceeded the range.
6. F2: Relative frequency of T1 or T2 has exceeded the range.
7. F3: Relative frequency of T2 has exceeded the range.
8. RL: Relative frequency of RBC-LD has exceeded the range.
9. RU: Relative frequency of RBC-UD has exceeded the range.
10. DW: Distribution width cannot be calculated.
11. MP: There are multiple peaks.
12. PL: Relative frequency of PLT-LD has exceeded the range.
13. PU: Relative frequency of PLT-UD has exceeded the range.
14. AG: The particle count equal to or less than WBC-LD has exceeded the range.
NOTE: • When analysis is made in the pre-diluted mode, no flag is displayed to
particle distribution analysis parameters. For details, refer to Chapter 9,
Section 6: Particle Distribution Analysis.
6 ) Menu Display Area
The Menu is displayed in accordance with the screen. For details, refer to Chapter 1,
Section 8.1: Contents of Display.
7 ) Patient Limit Graph
Synchronize with setting the Mark Limits value, and display whereabouts location of
the analysis value for a standard range.
Analysis value
Abnormal range Abnormal range
Center Mark Limit
Upper Mark LimitLower Mark Limit
Figure 3-2-7: Patient Limit Graph
8 ) WBC Particle Distribution Chart
The WBC Particle distribution chart is displayed.
9 ) RBC Particle Distribution Chart
The RBC Particle distribution chart is displayed.
10) PLT Particle Distribution Chart
The PLT Particle distribution chart is displayed.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 3-7
2.2 Manual Discrimination
This menu allows relocation of particle distribution discrimination position and re-calculation
of data.
CAUTION: • Manual Discrimination can be performed only on the latest sample
displayed on the Analysis screen, but not on the data with sample
number 0.
NOTE: • "1: M. Discri." on the menu is valid only for the analysis result in the
whole blood mode.
Execution of Manual Discrimination
(1) Press [1] key on the Analysis screen displaying analysis result and select "1: M.
Discri."
The pop-up menu to select the particle distribution for the manual discrimination will
appear.
1 : W B C
2 : R B C
3 : P L T
Figure 3-2-8: Pop-up Menu
(2) Using [ ] key or [ ] key to select a desired particle distribution for the manual
discrimination, and press [ENTER] key.
The Manual Discrimination screen appears.
M. Discri. Screen (WBC)
31/12 10:59No.123456789-12345 WB
WBC
NEUT# 3.5×103
/µL
MXD# 1.4×103
/µL
LYM# - 2.0×103
/µL
NEUT% 49.2%
MXD% 19.6%
LYM% 31.2%
WBC 7.1×103
/µL
T2 144 fL
T1 90 fL
LD 30 fL
*M.Discri.*
[ ][ ] for item, [ ][ ] for cursor
Figure 3-2-9: M. Discri. Screen (WBC)
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-8 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
M. Discri. Screen (RBC)
31/12 10:59No.123456789-12345 WB
RBC
RDW - 25.6fL
MCHC + 44.8g/dL
MCH 37.0pg
MCV - 82.6fL
HCT 32.8%
HGB 14.7g/dL
RBC 3.97×106
/µL
UD 250 fL
LD 25 fL
*M.Discri.*
[ ][ ] for item, [ ][ ] for cursor
Figure 3-2-10: M. Discri. Screen (RBC)
M. Discri. Screen (PLT)
31/12 10:59No.123456789-12345 WB
PLT
P-LCR - 9.5%
MPV 9.3fL
PDW - 7.9fL
PLT 180×103
/µL
UD 30 fL
LD 2 fL
*M.Discri.*
[ ][ ] for item, [ ][ ] for cursor
Figure 3-2-11: M. Discri. Screen (PLT)
(3) Using [ ] key or [ ] key, move the cursor to select the discriminator for manual
discrimination.
The discriminator selected on the Particle Distribution Chart is shown with solid line.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 3-9
(4) Using [ ] key or [ ] key, move the Discri. position on the Particle Distribution
Chart. The Discri. position relocated is displayed.
The range within which each Discri. position can move is shown below.
Table 3-2-1: M. Discri. Screen (WBC)
Discri. to Move Lower Limit Upper Limit
LD 6 fL (0ch) T1
T1 LD T2
T2 T1 UD
WBC particle distribution covers 50 channels of 0 to 49 (6 fL per channel), and the
channel changes by one at a time.
The relation between WBC particle distribution channel and fL display is as follows:
Discri. position (fL) = (Channel No. + 1) × 6
Table 3-2-2: M. Discri. Screen (RBC)
Discri. to Move Lower Limit Upper Limit
LD 5 fL (0ch) UD
UD LD 250 fL (49ch)
RBC particle distribution covers 50 channels of 0 to 49 (5 fL per channel), and the
channel changes by one at a time.
The relation between RBC particle distribution channel and fL display is as follows:
Discri. position (fL) = (Channel No. + 1) × 5
Table 3-2-3: M. Discri. Screen (PLT)
Discri. to Move Lower Limit Upper Limit
LD 1 fL (0ch) UD
UD LD 40 fL (39ch)
PLT particle distribution covers 40 channels of 0 to 39 (1 fL per channel), and the
channel changes by one at a time.
The relation between PLT particle distribution channel and fL display is as follows:
Discri. position (fL) = (Channel No. + 1) × 1
(5) After Discri. movement, press [ENTER] key.
The Discri. position is set and analysis data is re-calculated on the basis of new Discri.
position.
When [SELECT] key is pressed without pressing [ENTER] key, the Discri. position is
not changed, and the status returns to the Discri. position selection status.
(6) When you want to change another Discri., repeat the above (2) - (6) operation.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-10 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
(7) When Discri. change is finished, press [SELECT] key. The Setting Change
Confirmation Message appears.
OK to set? Cont. Set Cancel
Figure 3-2-12: Setting Change Confirmation Message
(8) Using [ ] key or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel,"
then press [ENTER] key.
[Cont.]: Returns to the M. Discri. screen and allows M. Discri. operation.
[Set]: Updates the contents and returns to the Analysis screen.
[Cancel]: Cancels the changed contents and returns to the Analysis screen.
(9) When you update the contents, analysis values changed in M. Discri. on the Analysis
screen are reverse-displayed.
31/12 10:59No.123456789-12345 WB
No.123456789-12346
PLT 180 P-LCR - 9.5
MCHC + 44.8 MPV 9.3
MCH 37.0 PDW - 7.9
MCV - 82.6 RDW-CV 20.5
HCT 32.8 RDW-SD - 25.6
HGB 14.7 NEUT% 49.2 3.5
RBC 39.7 MXD% 19.6 1.419.6 1.4
WBC 7.1 LYM% 31.2 2.231.2 2.2
Ready
1:M.Discri. 2:Output
Figure 3-2-13: Analysis Screen
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 3-11
2.3 External Output
This menu can be used to print out the latest sample's analysis result from the built-
in/external printer or output to the host computer. (The external printer is an option)
Printing to Printer
(1) Press [2] key on the Analysis screen and select "2: Output."
The pop-up menu to select the output destination will appear.
1 : H o s t
2 : D P
3 : G P
4 : L P
5 : I P
6 : I P F e e d
7:StopOutput
Figure 3-2-14: Pop-up Menu
(2) Using [ ] key or [ ] key to move the cursor to the desired printer, and press
[ENTER] key.
[1: Host]: Output the data to the host computer. Refer to "Output to Host
Computer" described later.
[2: DP]: The data printer starts printing the analysis result of the latest sample.
[3: GP]: The graphic printer starts graphic printing the analysis result of the
latest sample.
[4: LP]: This cannot be selected.
[5: IP]: The built-in printer starts printing the analysis result of the latest
sample.
[6: IP Feed]: Carries out the paper feed of the built-in printer.
[7: StopOutput]: This cannot be selected.
Contents of Printing
Contents of print with built-in printer
No. 123456789-12345
Date 31/10/1999
Time 10:02
Mode WB [W][R][P]
WBC WL+ 11.3 ×103
/µL
RBC 3.80 ×106
/µL
Mode Indication Parameter Discriminated Manually
Sample No.
Date Analyzed
Time Analyzed
Figure 3-2-15: Printing of Analysis Result (Built-in Printer)
NOTE: • For printing format of built-in printer, refer to Chapter 2, Section 5.2:
Printing of Analysis Result. To change the printing format, refer to
Chapter 10, Section 7.3: IP Output Settings.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-12 Sysmex KX-21N Operator’s Manual -- October 1999
Contents of print with graphic printer
Sample No.:123456789-12345 31/10/1999 16:40
Mode:WB Manual Ana:[W][R][P]
[ERROR]
WBC 7.3 [×103
/µL]
RBC 4.52 [×106
/µL]
HGB 14.8 [g/dL]
HCT 36.2 [%]
MCV 80.1 [fL]
MCH 32.7 [Pg]
MCHC 40.9 [g/dL]
WBC
Mode Indication
Parameter Discriminated
Manually
Sample No. Date Analyzed
Time Analyzed
Figure 3-2-16: Analysis Result Graphic Print (Graphic Printer)
Contents of print with data printer
HEMATOLOGY
Doctor
Age
Data
Sample No.
WBC
×103/µL
RBC
×106/µL
HGB
g/dL
HCT
%
MCV
fL
MCH
pg
MCHC
g/dL
W-SCR
%
W-MCR
%
W-LCR
%
W-SCC
×103/µL
W-MCC
×103/µL
W-LCC
×103/µL
RDW-CV
fL
10/12/1999
123456789012345
M
F
Carte No.
Name
Sample No.
Date Analyzed
5.6+
3.58
8.0
34.1
80.1
32.7
28.3
18.8
52.9
1.6
1.0
3.0
Figure 3-2-17: Analysis Result List Print (Data Printer)
1 ) Sample No.
The latest sample No. is printed.
2 ) Mode Indication
The mode in which sample was analyzed is printed. The whole blood mode is
printed as "WB" and the pre-diluted mode as "PD."
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 3-13
3 ) Date/Time Analyzed
Date and time when analysis result was obtained are printed.
4) Parameter Discriminated Manually
When M. Discri is used, the parameter discriminated manually are printed.
Output to Host Computer
(1) Press [2] key on the Analysis screen and select "2: Output."
The pop-up menu to select the output destination will appear.
(2) Using [ ] key or [ ] key to move the cursor to [1: Host], and press [ENTER] key.
Output the analysis data of the latest sample to the host computer.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-14 Sysmex KX-21N Operator’s Manual -- October 1999
3 . PROCESSING STORED DATA
This instrument is capable of storing data of up to 300 samples. The stored data is retained
after the power is turned off and can be called up unless deleted.
NOTE: • When the stored data exceeds 300, the oldest data are automatically
deleted.
3.1 Executing and Quitting Stored Data Processing Program
Executing the Program
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "1: Stored Data."
(3) Press [ENTER] key. The Stored Data screen [1/7] appears.
Date
31/12
31/12
31/12
31/12
31/12
31/12
31/12
31/12
No.123456789-12345 31/12 10:59 [1/7]
Time
09:59
10:05
10:10
10:25
10:28
10:30
10:40
10:50
No
123456789-12341*B WB DGH
QC01 M QC DGH
123456789-12335 M WB DGH
123456789-12337 M WB DGH
123456789-12344 M PD DGH E
123456789-12345 A PD DG
123456789-12346 A WB GH
123456789-12341*M WB D
*Stored Data*
[ENTER] to mark. 3:Chg.Disp.
Figure 3-3-1: Stored Data Screen
Quitting the Program
(1) Press [SELECT] key on the Stored Data screen. The Analysis screen returns.
NOTE: • The sample No. and analysis mode on the Analysis screen return to
the status before the execution of the stored data processing program.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 3-15
3.2 Stored Data Screen
The Stored Data screen lists data of up to eight samples in the order of analysis. When the
first Stored Data screen is displayed after turning on the power, the data of the last eight
samples on the list are displayed. When a new sample is analyzed, its data is automatically
added to the last line of the list.
As to analysis data, up to four parameters are displayed on one page, and can be switched to
the screen over seven pages with [ ] key or [ ] key. The analyzed date and information
on the analysis data such as error mark etc. will appear on the first page ([1/7]).
P1. Stored Data Screen [1/7]
P2. Stored Data Screen [2/7]
P7. Stored Data Screen [7/7]
P3. Stored Data Screen [3/7]
P6. Stored Data Screen [6/7]
P4. Stored Data Screen [4/7]
P5. Stored Data Screen [5/7]
Figure 3-3-2: Page Selection in the Stored Data Screen
Date
31/12
31/12
31/12
31/12
31/12
31/12
31/12
31/12
No.123456789-12345 31/12 10:59 [1/7]
Time
09:59
10:05
10:10
10:25
10:28
10:30
10:40
10:50
No
123456789-12341*B WB DGH
QC01 M QC DGH
123456789-12335 M WB DGH
123456789-12337 M WB DGH
123456789-12344 M PD DGH E
123456789-12345 A PD DG
123456789-12346 A WB GH
123456789-12341*M WB D
*Stored Data*
[ENTER] to mark. 3:Chg.Disp.
Figure 3-3-3: Stored Data Screen [1/7]
No.
-12341* WB 7.7+
QC 7.5
-12346 WB 7.5+
-12345 WB 7.1
-12344 PD 7.2
-12337 PD 5.5-
-12335 WB 7.0
-12341* WB 7.6+
No.123456789-12341 31/12 10:50 [2/7]
WBC RBC
3.97
4.51
3.85
4.30+
3.91
3.90
4.05
3.98
HGB
14.7
14.1
13.8
12.2
14.3
15.1
18.5
15.0
HCT
32.8
34.7
30.5
29.5-
32.0
40.2+
31.4
35.1
*Stored Data*
[ENTER] to mark. 3:Chg.Disp.
Figure 3-3-4: Stored Data Screen [2/7]
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-16 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
Key Operation for Stored Data Screen
[ ] key: Moves up the underline cursor by one sample. When the underline
cursor is at the top, the list scrolls down.
[ ] key: Moves down the underline cursor by one sample. When the
underline cursor is at the bottom, the list scrolls up.
[ ], [ ] key: Changes over the page.
[ENTER] key: Attaches or deletes marks.
[SAMPLE No.] key: Allows you to correct the sample number at the underline cursor.
[3] key: Displays the data at the underline cursor by the same form as
Analysis screen.
1:M.Discri. 2:Output 3:Chg.Disp.
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
+ 7.7
3.97
14.7
32.8
- 82.6
37.0
44.8
180
No.123456789-12341 WB 31/12 10:50
LYM%
MXD%
NEUT%
RDW-SD
RDW-CV
PDW
MPV
P-LCR
31.2
19.6
49.2
- 25.6
20.6
- 7.9
9.3
- 9.5
2.2
1.4
3.5
*Stored Data*
Figure 3-3-5: Stored Data Screen
The screen can be switched with [ ] key or [ ] key as well as
Analysis screen, and press [3] key to return to Stored Data screen.
For details on how to display Analysis screen, refer to Chapter 3,
Section 2.1: Display of Analysis Result.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 3-17
Marking
To mark the analysis data, specify an analysis data using the underline cursor and press
[ENTER] key.
The marked analysis data has a added to its left end and the underline cursor moves to the
next analysis data. When an analysis data is marked, the Menu Display Area displays:
“1: Delete”, “2: Output”, “3: Chg. Disp.” When the mark is already attached, press [ENTER]
key to delete it.
NOTE: • When you keep pressing [ENTER] key, the marking is made
continuously.
• When you return to the Analysis screen, all the marks on analysis data
are deleted.
No.
-12341* WB 7.7+
QC 7.5
-12335 WB 7.5+
-12337 WB 7.1
-12344 PD 7.2
-12345 PD 5.5-
-12346 WB 7.0
-12341* WB 7.6+
No.123456789-12345 31/12 10:30 [2/7]
WBC RBC
3.97
4.51
3.85
4.30+
3.91
3.90
4.05
3.98
HGB
14.7
14.1
13.8
12.2
14.3
15.1
18.5
15.0
HCT
32.8
34.7
30.5
29.5-
32.0
40.2+
31.4
35.1
1:Delete 2:Output 3:Chg.Disp.
*Stored Data*
Figure 3-3-6: Marking the Data
Display Contents of Stored Data Screen
Date
31/12
31/12
31/12
31/12
31/12
31/12
31/12
31/12
No.123456789-12335 31/12 10:10 [1/7]
Time
09:59
10:05
10:10
10:25
10:28
10:30
10:40
10:50
No
123456789-12341*B WB DGH
QC01 M QC DGH
123456789-12335 M WB DGH
123456789-12337 M WB DGH
123456789-12344 M PD DGH E
123456789-12345 A PD DG
123456789-12346 A WB GH
123456789-12341*M WB D
*Stored Data*
[ENTER] to mark. 3:Chg.Disp.
Not-output Mark
Error Mark
Data at Underline
Cursor
Sample No. Input Attributes
Mode Indication
Sample No.
Date Analyzed
Time Analyzed
Figure 3-3-7: Stored Data Screen [1/7]
Sysmex KX-21N Operator’s Manual -- Revised June 2001
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-18 Sysmex KX-21N Operator’s Manual -- October 1999
No.
-12341* WB 7.7+
QC 7.5
-12335 WB 7.5+
-12337 WB 7.1
-12344 PD 7.2
-12345 PD 5.5-
-12346 WB 7.0
-12341* WB 7.6+
No.123456789-12335 31/12 10:10 [2/7]
WBC RBC
3.97
4.51
3.85
4.30+
3.91
3.90
4.05
3.98
HGB
14.7
14.1
13.8
12.2
14.3
15.1
18.5
15.0
HCT
32.8
34.7
30.5
29.5-
32.0
40.2+
31.4
35.1
*Stored Data*
[ENTER] to mark. 3:Chg.Disp.
Data at Underline
Cursor
Mode Indication Analysis Data
Sample No.
Figure 3-3-8: Stored Data Screen [2/7]
1 ) Data/Time Analyzed
The date and the time when analyzed the analysis data are displayed.
2 ) Sample No.
The sample No. of stored data is displayed.
The sample number is displayed by all of the 15 digits on [1/7] screen, but displayed
by only 6 last digits on [2/7] to [7/7] screens.
Identical sample Nos. processed on an identical analysis date are marked with * at the
ends of the Nos. QC data are displayed in the format of "QC + File No."
3 ) Sample No. Input Attributes
How to input the sample number is displayed by the marks
1. M: The sample number was input with the panel keyboard.
2. B: The sample number was input with the hand held barcode reader.
3. A: The sample number was input by automatic increment.
4 ) Mode Indication
The analysis mode for stored data is displayed.
"PD" is indicated for the pre-diluted mode while no indication is given for the whole
blood mode.
1. WB: Whole blood mode
2. PD: Pre-diluted mode
3. QC: QC data
5 ) Not-output Mark
It is displayed whether to output data to an external printer or the host computer by the
marks.
1. D : The data has not been printed to the data printer. The mark disappears when
printed.
2. G : The data has not been printed to the graphic printer. The mark disappears when
printed.
3. H : The data is not output to the host computer. The mark disappears when output.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 3-19
6 ) Error Mark
The E mark is displayed in data which an error occurs.
7 ) Analysis Data
Analysis data of 17 parameters are displayed on over six pages of [2/7] to [7/7].
Stored Data Screen [2/7]: WBC, RBC, HGB, HCT
Stored Data Screen [3/7]: MCV, MCH, MCHC, PLT
Stored Data Screen [4/7]: WBC, LYM%, MXD%, NEUT%
Stored Data Screen [5/7]: WBC, LYM#, MXD#, NEUT#
Stored Data Screen [6/7]: RDW-SD, RDW-CV
Stored Data Screen [7/7]: MPV
• Manual Discrimination Data
As to data changed through manual discrimination, analysis values are reverse-
displayed.
• Abnormal Marks
The marks on the left of analysis data indicate the following:
1. ! : The data is out of the linearity limit.
2. * : The data is low in reliability because of a histogram error.
3. + : The data exceeds the upper Mark Limits.
- : The data exceeds the lower Mark Limits.
NOTE: • The marks are added with the priority order of 1, 2, and 3.
• The Mark Limits with "+" and "-" can be set by the customer. For
details, refer to Chapter 10, Section 4: Patient Limit.
• Indication when Error
When an analysis error, etc. has caused errors in analysis data, the marks below are
attached to the affected data:
1. + + +. +: When data has exceeded the display range.
2. * * *. *: When data could not be calculated due to instrument failure.
3. - - -. -: When data could not be calculated due to data error.
NOTE: • When analysis is made in the pre-diluted mode, particle distribution
analysis parameters are displayed in "- - -. -."
8 ) Data at Underline Cursor
The sample number (15 digits), the analyzed date, and the analyzed time of the analysis
data on the underline cursor are displayed.
Sysmex KX-21N Operator’s Manual -- Revised May 2003 N.A.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-20 Sysmex KX-21N Operator’s Manual -- October 1999
3.3 Deletion
This menu allows deletion of marked analysis data from stored data.
Execution of Deletion
(1) Using the underline cursor, specify the analysis data you want to delete and press
[ENTER] key. This puts the mark on the analysis data.
(2) Press [1] key to select "1: Deletion." The Deletion Confirmation message appears.
Delete? YES NO
Figure 3-3-9: Deletion Confirmation Message
(3) Using [ ] key or [ ] key, move the cursor to select "Yes" or "NO."
[Yes]: Deletes the marked analysis data.
[NO]: Cancels deletion.
(4) Press [ENTER] key to execute the selected process.
When you press [SELECT] key, the process is canceled.
NOTE: • Before deleting data, make sure the KX-21N completes any output
operation to the printer or host computer.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 3-21
3.4 External Output
This menu allows the marked analysis data to be printed by the built-in/external printer, or
output to the host computer. (The external printer is an option.)
Printing to Printer
(1) Using the underline cursor, specify the analysis data you want to print and press
[ENTER] key. This puts the mark on the analysis data.
(2) Press [2] key to select "2: Output."
The pop-up menu to select the output destination will appear.
1 : H o s t
2 : D P
3 : G P
4 : L P
5 : I P
6 : I P F e e d
7:StopOutput
Figure 3-3-10: Pop-up Menu
(3) Using [ ] key or [ ] key to move the cursor to the desired printer, and press
[ENTER] key.
[1: Host]: Output the data to the host computer. Refer to "Output to Host
Computer" described later.
[2: DP]: This cannot be selected.
[3: GP]: The graphic printer starts graphic printing the marked analysis data.
[4: LP]: The graphic printer starts list printing the marked analysis data.
[5: IP]: The built-in printer starts printing the marked analysis data.
[6: IP Feed]: Carries out the paper feed of the built-in printer.
[7: StopOutput]: When two or more analysis data are output, this can be selected,
and the output will be interrupted when you select this.
When the print to the printer is completed, disappearing the not-output mark for the
printer which corresponding to the printed analysis data.
NOTE: • For print format other than the LP (list print with the graphic printer),
refer to Chapter 2, Section 5.2: Printing of Analysis Result or Chapter
3, Section 2.3 External Output.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
3-22 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
Contents of Printing
List print with the graphic printer
Print Date 31/10/1999
Print Time 16:40
Sample No.
Date
Ana.Inf.
123456789-12344
31/10/1999 12:15
W R P
Mode Err.
P E
WBC
RDW-SD
LMY%
7.3
8.3
27.2
RBC
RDW-CV
MXD% NEUT% LMY# MXD# NEUT#
4.52 14.8 36.2 80.1 32.7
15.0 8.3
13.4 59.4 2.0 2.0 4.3
40.9
9.1
206
14.8
HGB HCT MCV MCH MCHC PLT
PDW MPV P-LCR
page( 1)
Figure 3-3-11: Stored Data List Print
Output to Host Computer
(1) Using the underline cursor, specify the analysis data you want to output to the host
computer and press [ENTER] key. This puts the mark on the analysis data.
(2) Press [2] key to select "2: Output."
The pop-up menu to select the output destination will appear.
1 : H o s t
2 : D P
3 : G P
4 : L P
5 : I P
6 : I P F e e d
7:StopOutput
Figure 3-3-12: Pop-up Menu
(3) Using [ ] key or [ ] key to move the cursor to [1: Host], and press [ENTER] key.
The analysis data is output to the host computer in order that the mark is put.
The not-output of the output analysis data to the host computer disappears when the
output to the host computer is completed.
Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Sysmex KX-21N Operator’s Manual -- October 1999 3-23
3.5 Correcting a Sample Number
Use the [SAMPLE No.] key to correct a sample number of analysis data.
(1) Use the underline cursor to select the desired analysis data, then press the [SAMPLE
No.] key. The sample number on the bottom of the screen will be highlighted.
No.123456789-12345 31/12 10:30 [2/7]
-12345 PD 5.5-
-12346 WB 7.0
-12341* WB 7.6+
3.90
4.05
3.98
15.1
18.5
15.0
40.2+
31.4
35.1
[ENTER] to mark. 3:Chg.Disp.
Figure 3-3-13: Correcting a Sample Number
(2) Use the numeric keypad to enter a new sample number, then press the [ENTER] key.
(3) When the confirmation message appears, select the [Set] button.
The sample number is changed, and the sample number input attribute becomes "M".
Sysmex KX-21N Operator’s Manual -- October 1999
CHAPTER 4 MAINTENANCE AND
SUPPLIES REPLACEMENT
1. INTRODUCTION ................................................................. 4-1
2. KX-21N MAINTENANCE CHECKLIST ..................................... 4-2
3 DAILY MAINTENANCE AND PROCEDURE ............................... 4-4
3.1 Clean TD Chamber and Diluted Sample Line (Shutdown)............. 4-4
3.2 Check Trap Chamber Level and Discard ................................. 4-6
4. WEEKLY MAINTENANCE AND PROCEDURE............................ 4-7
4.1 Clean SRV Tray............................................................. 4-7
5. MONTHLY MAINTENANCE AND PROCEDURE ......................... 4-9
5.1 Clean Waste Chamber (Rinse Sequence)................................. 4-9
5.2 Clean Transducer (Rinse Sequence) .....................................4-12
6. EVERY 3-MONTH MAINTENANCE AND PROCEDURE .............. 4-16
6.1 Clean Sample Rotor Valve (SRV)........................................4-16
6.2 Reset SRV Cycle Counter ................................................4-22
7. AS-NEEDED MAINTENANCE AND PROCEDURE...................... 4-24
7.1 Auto Rinse ..................................................................4-24
7.2 Clean Rinse Cup ...........................................................4-26
7.3 Clean WBC/RBC Transducer Aperture .................................4-28
7.4 Replace Waste Tank .......................................................4-32
8. SUPPLIES REPLACEMENT.................................................. 4-33
8.1 Replenish Reagent .........................................................4-33
8.2 Replace Fuse................................................................4-36
8.3 Replace Printer Paper......................................................4-37
8.4 Supplies List................................................................4-40
9. CONFIRMATION OF CYCLE NUMBER................................... 4-41
9.1 Operation Procedure ...................................................... 4-41
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-1
1 . INTRODUCTION
To ensure that the instrument can function in its best state, it is necessary to give scheduled
maintenance. Perform maintenance according to the schedule below and record the result in
the Maintenance Checklist.
• Daily Maintenance
Clean the TD chamber and diluted sample line. (Execute shutdown.)
Check trap chamber level, and discard if necessary.
• Weekly Maintenance
Clean the sample rotor valve (SRV) tray.
• Monthly Maintenance (or Every 2500 Samples)
Clean the waste chamber (rinse sequence).
Clean the transducer (rinse sequence).
• Every 3-Month Maintenance (or Every 7500 Samples)
Clean the sample rotor valve (SRV).
• As-Needed Maintenance
Auto Rinse
Clean the rinse cup.
Clean WBC/RBC transducer aperture.
Replace the waste tank.
This chapter describes supplies replacement together with these maintenance items.
• Supplies Replacement
Replenish reagent.
Replace fuses.
Replace printer paper.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-2 Sysmex KX-21N Operator’s Manual -- October 1999
2 . KX-21N MAINTENANCE CHECKLIST
Signature
12345678910111213141516171819202122232425262728293031
DailyMaintenance
Executeshutdown
Checktrapchamber
levelanddrain
Signature
12345
Cleansamplingvalve(SRV)tray
WeeklyMaintenance
MaintenanceItem
Day
MaintenanceItemWeek
Date,SignatureMaintenanceitem
Cleanwastechamber(Rinsesequence)
Cleantransducer(Rinsesequence)
MonthlyMaintenance
Date,Signature
Maintenanceitem
Replaceprinterpaper
Date,Signature
Replenishreagent
Replacefuse
SuppliesReplacement
Cleansamplerotorvalve(SRV)
MaintenanceitemDate,Signature
Every3-MonthMaintenance
Date,Signature
MaintenanceitemDate,Signature
CleanWBC/RBCtransduceraperture
Replacewastetank
Cleanrinsecup
Autorinse
As-NeededMaintenance
Year:Month:
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-3
Reagent Replenishment Record
CELLPACK
STROMATOLYSER-WH
Lot No. DateExpiry Signature Expiry
Date Expiry Expiry
Date
DateLot No.Lot No.
Lot No.
Signature
Signature
Signature
MAINTENANCE AND SUPPLIES REPLACEMENT
4-4 Sysmex KX-21N Operator’s Manual -- October 1999
3 . DAILY MAINTENANCE AND PROCEDURE
3.1 Clean TD Chamber and Diluted Sample Line (Shutdown)
By executing shutdown, the transducer chamber and diluted sample line are cleaned.
Perform shutdown after completion of the day's work, and also at least once every 24 hours
when this instrument is used continuously.
(1) Press [SHUTDOWN] key in the Ready status. The Shutdown screen appears.
3:Cancel
*Shutdown*
Aspirate CELLCLEAN.
It will take approx. 5 minutes.
Ready
Figure 4-3-1: Shutdown Screen
NOTE: • When [3] key is pressed, shutdown is canceled and the Analysis
screen returns.
(2) In executing shutdown, set CELLCLEAN to the sample probe and press the start
switch in that status. While "Aspirating" is being displayed on the screen, keep
holding CELLCLEAN in the same state.
Start Switch
Figure 4-3-2: Pressing the Start Switch
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-5
• Because CELLCLEAN is a strong alkaline detergent, take care not to
have it adhere to the skin or clothes. If the skin or clothes should come
in touch with it, flush it away using plenty of water. Otherwise, it can
damage the skin or clothes.
NOTE: • Once shutdown is executed, it cannot be canceled until completed.
(3) When the buzzer sounds two times - beep, beep, - informing the completion of
aspiration, remove CELLCLEAN from the sample probe. After that, shutdown is
executed automatically.
Rinsing
*Shutdown*
Please wait.
Figure 4-3-3: Shutdown Execution Screen
CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to bend
the sample probe.
(4) When shutdown is completed and the following message is displayed, turn off the
power switch on the right side of the unit.
1:Re-boot
Shut-down sequence was completed.
Turn OFF the power.
*Shutdown*
Figure 4-3-4: Shutdown Completion Message Screen
WARNING
MAINTENANCE AND SUPPLIES REPLACEMENT
4-6 Sysmex KX-21N Operator’s Manual -- October 1999
NOTE: • Shutdown will take approximately 5 minutes.
• When the [1] key is pressed, the unit will restart.
3.2 Check Trap Chamber Level and Discard
After completion of analyses for the day, check trap chamber level and discard any liquid that
has collected.
(1) Turn off the power and wait approximately 30 seconds.
(2) Turn the chamber on the left side of the unit counterclockwise and remove.
Trap Chamber
Loosen
Float
Figure 4-3-5: Checking the Trap Chamber
(3) After discarding the liquid, mount the chamber. Make sure the float is inside.
• When discarding the trap chamber liquid, always wear rubber gloves.
After completion of operation, wash hands with disinfectant. If your
hands are contaminated by the liquid, infection of bacteria or the like can
occur.
• If liquid collects everyday, the hydraulic system may have failed.
Contact Sysmex service representative.
• Pay attention to the direction of the float in the chamber. Place it with its
pointed end facing upward.
WARNING
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-7
4 . WEEKLY MAINTENANCE AND PROCEDURE
4.1 Clean SRV Tray
Clean the sample rotor valve (SRV) tray once a week in the following procedure:
• When cleaning the SRV tray, always wear rubber gloves. After
completion of operation, wash hands with disinfectant. If your hands
are contaminated by blood, etc., infection of bacteria or the like can
occur.
(1) Turn off the power of the main unit and wait approximately 30 seconds.
(2) Open the front cover of the main unit.
(3) Remove the SRV tray.
Tray
Probe Fixing Screw
Figure 4-4-1: Removing the SRV Tray
• When removing the tray, take care not to loosen the probe fixing screw.
If analysis is made with the screw loosened, air can enter the system
and affect the data.
(4) Wash the SRV tray using tap water.
Tray
Figure 4-4-2: Washing the SRV Tray
WARNING
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
4-8 Sysmex KX-21N Operator’s Manual -- October 1999
(5) Make sure no contaminants remain, then wipe off water.
(6) Re-mount the SRV tray to the original state.
• After mounting the tray, make sure the probe fixing screw is not loose.
If analysis is made with the screw loosened, air can enter the system
and affect the data.
CAUTION: • Mount the SRV tray properly as to the face/bottom and the direction.
(7) Close the front cover of the main unit.
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-9
5 . MONTHLY MAINTENANCE AND PROCEDURE
5.1 Clean Waste Chamber (Rinse Sequence)
When the power is turned on, the message is displayed once a month or for every 2500
samples to instruct the scheduled maintenance.
1:Exec.Clean 3:Cancel
*Scheduled Maint.*
Clean the Waste Chamber.
It will take approx. 15 minutes.
Cycle No. after cleaning. 2515
Date last serviced 1/12/1999
Figure 4-5-1: Scheduled Maintenance Message Screen
When this message appears, press [1] key to select "1: Exec. Clean," and clean the waste
chamber by the following procedure:
NOTE: • When you press [3] key and select "3: Cancel," the start-up process
continues without cleaning the waste chamber. Until the waste
chamber is cleaned, the above message is displayed at start-up.
• Even when the above message is not displayed, you can execute the
waste chamber cleaning by choosing "7: Maintenance" on the Select
Menu screen, then "1: Clean W. Chamber" on the Maintenance Menu
screen.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-10 Sysmex KX-21N Operator’s Manual -- October 1999
(1) Press [1] key to select "1: Exec. Clean" on the Scheduled Maintenance Message
screen. The Clean W. Chamber screen will display the message instructing the
following operation:
*Clean W.Chamber*
Cycle No. after cleaning. 2515
Date last serviced 1/12/1999
3:Cancel
Ready
Aspirate CELLCLEAN
It will take approx. 15 minutes.
Figure 4-5-2: Clean W. Chamber Screen
NOTE: • When you press [3] key and select "3: Cancel," the start-up process
continues without cleaning the waste chamber. Until the waste
chamber is cleaned, the above message is displayed at start-up.
(2) Set CELLCLEAN to the sample probe and press the start switch in that status. While
"Aspirating" is being displayed on the screen, keep holding CELLCLEAN in the same
status.
Start Switch
Figure 4-5-3: Pressing the Start Switch
• Since CELLCLEAN is a strong alkaline detergent, take care not to have
it adhere to the skin or clothes. If the skin or clothes should come in
touch with it, flush it away using plenty of water. Otherwise, it can
damage the skin or clothes.
WARNING
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-11
(3) When the buzzer sounds two times - beep, beep , - informing completion of aspiration,
remove CELLCLEAN from the sample probe. After that, the waste chamber cleaning
is executed automatically.
*Clean W.Chamber*
Please wait.
Figure 4-5-4: Screen during Waste Chamber Cleaning
CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to bend
the sample probe.
(4) When the waste chamber cleaning is completed, the auto rinse and background check
are executed, then the system turns to the Ready status.
(5) Check to see that no background error occurs. Should background error occur,
execute the auto rinse.
NOTE: • When this operation is completed, the waste chamber cycle counter is
automatically reset. For the confirmation of waste chamber cycle
number, refer to Chapter 4, Section 9: CONFIRMATION OF CYCLE
NUMBER.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-12 Sysmex KX-21N Operator’s Manual -- October 1999
5.2 Clean Transducer (Rinse Sequence)
When the power is turned on, the message is displayed once a month or for every 2500
samples to instruct the scheduled maintenance.
1:Exec. Clean
Clean the Transducer.
It will take approx. 7 minutes.
*Scheduled Maint.*
Cycle No. after cleaning. 2515
Date last serviced 1/12/1999
3:Cancel
Figure 4-5-5: Scheduled Maintenance Message Screen
When this message appears, press [1] key to select "1: Exec. Clean," and clean the
transducer by the following procedure:
In addition, the error message of clogging is displayed. Even when the clogging is not
removed, clean the transducer using the same procedure.
NOTE: • When you press [3] key and select "3: Cancel," the start-up process
continues without cleaning the transducer. Until the transducer is
cleaned, the above message is displayed at start-up.
• Even when the above message is not displayed, you can execute the
transducer cleaning by choosing "7: Maintenance" on the Select Menu
screen, then "2: Clean Transducer" on the Maintenance Menu screen.
• If this rinse sequence fails to remove clogging, clean with the brush.
Regarding cleaning with the brush, refer to Chapter 4, Section 7.3:
Clean WBC/RBC Transducer Aperture.
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-13
(1) Press [1] key to select "1: Exec. Clean" on Scheduled Maintenance Message screen.
Fluid in the transducer is drained and the Clean Transducer screen appears.
*Clean Transducer*
Pour CELLCLEAN in transducer chamber
and press START switch.
Cycle No. after cleaning. 2515
Date last serviced 1/12/1999
3:Cancel
Ready
Figure 4-5-6: Clean Transducer Screen
NOTE: • When you press [3] key and select "3: Cancel," the start-up process
continues without cleaning the transducer. Until the transducer is
cleaned, the above message is displayed at start-up.
(2) Open the front cover of the main unit.
(3) Open the transducer cover.
Figure 4-5-7: Opening the Transducer Cover
MAINTENANCE AND SUPPLIES REPLACEMENT
4-14 Sysmex KX-21N Operator’s Manual -- October 1999
(4) Using the filler provided with the unit, pour approximately 1 mL each of
CELLCLEAN into the WBC transducer and RBC transducer.
Filler
Figure 4-5-8: Pouring CELLCLEAN
• Since CELLCLEAN is a strong alkaline detergent, take care not to have
it adhere to the skin or clothes. If the skin or clothes should come in
touch with it, flush it away using plenty of water. Otherwise, it can
damage the skin or clothes.
• Do not pour more than 1 mL of detergent (CELLCLEAN) into the
chamber. It may overflow, possibly causing electric shocks or leakage.
CAUTION: • Take care not to have detergent (CELLCLEAN) adhere to the chamber
side wall.
(5) Close the transducer cover.
(6) Close the front cover of the main unit.
WARNING
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-15
(7) Press the start switch. The transducer cleaning is executed.
*Clean Transducer*
Please wait.
Figure 4-5-9: Screen during Transducer Cleaning
(8) When the transducer cleaning is completed, the auto rinse and background check are
executed, then the system turns to the Ready status.
(9) Check to see that no background error occurs. Should background error occur,
execute the auto rinse.
NOTE: • When this operation is completed, the transducer cycle counter is
automatically reset. For the confirmation of transducer cycle number,
refer to Chapter 4, Section 9: CONFIRMATION OF CYCLE
NUMBER.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-16 Sysmex KX-21N Operator’s Manual -- October 1999
6 . EVERY 3-MONTH MAINTENANCE AND PROCEDURE
6.1 Clean Sample Rotor Valve (SRV)
When the power is turned on, the message is displayed once every three months or for every
7500 samples to instruct the scheduled maintenance.
*Scheduled Maint.*
Cycle No. after cleaning. 7515
Date last serviced 1/12/1999
1:Exec.Clean
Clean the SRV.
Reset the cycle counter for SRV,
and you can turn OFF the power.
[1]
[3] Continue to start up. SRV cycle
counter will not be reset.
3:Cancel
Figure 4-6-1: Scheduled Maintenance Message Screen
When this message appears, press [1] key to select "1: Exec. Clean," and reset the cycle
counter. Then clean the sample rotor valve (SRV) by the following procedure:
• When cleaning the sample rotor valve (SRV), always wear rubber
gloves. After completion of operation, wash hands with disinfectant. If
your hands are contaminated by blood, etc., infection of bacteria or the
like can occur.
• Because CELLCLEAN is a strong alkaline detergent, take care not to
have it adhere to the skin or clothes. If the skin or clothes should come
in touch with it, flush it away using plenty of water. Otherwise, it can
damage the skin or clothes.
NOTE: • When you press [3] key and select "3: Cancel," the start-up process
continues without cleaning the sample rotor valve (SRV). Until the
sample rotor valve (SRV) is cleaned, the above message is displayed
at start-up.
• When you want to clean before this message appears, or when you
selected "3: Cancel" on the Scheduled Maint. screen and executed
cleaning when the power was off, reset the cycle counter, making
reference to Chapter 4, Section 6.2: Reset SRV Cycle Counter.
WARNING
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-17
(1) Press [1] key to select "1: Exec. Clean" on the Scheduled Maintenance Message
screen. The SRV cycle counter is reset and the unit is ready to be turned off.
*Scheduled Maint.*
SRV cycle counter was reset.
Turn OFF the power.
Figure 4-6-2: Clean SRV Screen
CAUTION: • Before turning the power off, always select "1: Exec. Clean," making
the unit ready to be turned off.
(2) Turn off the power of the main unit and wait approximately 30 seconds.
(3) Open the front cover of the main unit.
(4) Remove the sample rotor valve (SRV) tray.
Tray
Probe Fixing Screw
Figure 4-6-3: Removing the Tray
MAINTENANCE AND SUPPLIES REPLACEMENT
4-18 Sysmex KX-21N Operator’s Manual -- October 1999
• When removing the tray, take care not to loosen the probe fixing screw.
If analysis is made with the screw loosened, air can enter the system
and affect the data.
(5) Gently push down the rinse cup using both hands. Make sure the rinse cup is
removed completely from the sample probe.
Sample Probe
Rinse Cup
Figure 4-6-4: Pushing Down the Rinse Cup
CAUTION: • If the rinse cup is not completely removed from the sample probe, there
is a possibility that the sample probe may bend when the sample rotor
valve (SRV) is removed.
(6) Remove the SRV fixing screw.
SRV Fixing Screw
Loosen
Figure 4-6-5: Removing the SRV Fixing Screw
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-19
(7) Remove the entire sample rotor valve (SRV).
Sample Rotor Valve
Figure 4-6-6: Removing the Entire SRV
CAUTION: • Take care not to pull out the valve excessively. This is to prevent
applying excess force to the tube connected to the valve.
• When removing the valve, take care not to bend the sample probe.
(8) Remove the rotary valve.
Rotary Valve
Figure 4-6-7: Removing the Rotary Valve
• When removing the valve, reagent could leak from the tube. If it does,
wipe it clean using cloth. If left as it is, it can cause current leakage or
electric shocks.
NOTE: • The valve components are in close contact with one another. They
can be easily removed when you gently twist and slide each one.
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
4-20 Sysmex KX-21N Operator’s Manual -- October 1999
(9) Clean the rotary valve using distilled water or 1:10 dilution of CELLCLEAN detergent.
After cleaned with CELLCLEAN, always clean it with distilled water.
(10) Clean the contact surfaces of the fixed and rotary valves using a gauze moistened with
distilled water. By using CELLCLEAN together with distilled water, stuck objects,
dirt, etc. can be removed easily.
Figure 4-6-8: Cleaning the Contact Faces
• Take care not to inflict flaws or scratches on valve surfaces, since flaws
or scratches can cause blood leakage and incorrect analysis results.
CAUTION: • Do not use any detergent other than CELLCLEAN. Although the
sample rotor valve (SRV) is corrosion-resistant against CELLCLEAN,
wipe it off completely to prevent troubles to the unit or other
components.
(11) Make sure the valve contact surfaces are completely free from dirt or dust.
• If the device is used with dirt or dust attaching on valve contact
surfaces, blood leakage can occur and correct analysis results may not
be obtained.
(12) Install one each valve at a time, and assemble the sample rotor valve (SRV) in the
reverse order to disassembly.
CAUTION
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-21
CAUTION: • Mount the rotary valve with the notch facing upward and the metal
knob coming between the stoppers.
Stopper
Metal Knob
Groove
Guide Pin for Rotary Valve
(View of Left Side)
Figure 4-6-9: Rotary Valve
• Confirm that the metal knob is between the stoppers. If it is not,
malfunction will occur.
(13) Mount the SRV tray to the original position and gently push up the rinse cup to the top
using both hands.
CAUTION: • Mount the SRV tray properly as to its face/bottom and the direction.
• Make sure the rinse cup is pushed all the way up with the sample
probe inserted in the hole. If the power is turned on with the rinse cup
staying lowered, "Rinse Motor Error" will occur, making it impossible to
continue the operation.
(14) Close the front cover of the main unit.
(15) Turn on the main unit and make sure that the background error has not occurred.
(16) Perform quality control and make sure that there is no functional problem.
NOTE: • When this operation is completed, the SRV cycle counter is
automatically reset. For confirmation of SRV cycle number, refer to
Chapter 4, Section 9: CONFIRMATION OF CYCLE NUMBER.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-22 Sysmex KX-21N Operator’s Manual -- October 1999
6.2 Reset SRV Cycle Counter
If you have cleaned the SRV other than the time when instructed on the Scheduled
Maintenance screen, always reset the SRV cycle counter manually.
NOTE: • If you continue using the unit without resetting the SRV cycle counter,
the message will instruct you to perform scheduled maintenance within
three months (or before analyzing 7500 samples).
• For SRV cleaning procedure, refer to Chapter 4, Section 6.1: Clean
Sample Rotor Valve (SRV).
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Use [ ] key or [ ] key, move the cursor to select "7: Maintenance."
(3) Press [ENTER] key. The Maintenance Menu screen appears.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
Figure 4-6-10: Maintenance Menu Screen
(4) Use [ ] key or [ ] key, move the cursor to select "3: Reset SRV Counter."
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-23
(5) Press [ENTER] key. The Rest SRV Counter screen appears.
*Reset SRV Counter*
3:Cancel1:Reset
1 SRV cycle counter will be reset.[ ]
Cycle No. after cleaning. 6015
Date last serviced 1/12/1999
Figure 4-6-11: Reset SRV Counter Screen
(6) Press [1] key to select "1: Reset." "Cycle No. after cleaning" is reset to "0," the date
of the present day is entered in the "Date last serviced" column, then the Analysis
screen returns.
NOTE: • Press [3] key to select "3: Cancel." The cycle counter is not reset, and
the Analysis screen returns.
• For confirmation of SRV cycle counter, refer to Chapter 4, Section 9:
CONFIRMATION OF CYCLE NUMBER.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-24 Sysmex KX-21N Operator’s Manual -- October 1999
7 . AS-NEEDED MAINTENANCE AND PROCEDURE
When the transducer is clogged or the waste tank becomes full, perform the necessary
maintenance.
7.1 Auto Rinse
Execute the Auto Rinse at background check or when the unit has been left idle without
shutdown performed. The Auto Rinse cleans all the lines in the unit and drains all waste.
Background check is also implemented to allow checking whether the unit is in normal status
or not.
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "5: Auto Rinse."
*SELECT*
1:Stored Data
2:Quality Control
3:Calibration
4:Replace Lyse
5:Auto Rinse
6:Settings
7:Maintenance
8:Periph. Settings
00:PU Sleep
Figure 4-7-1: Select Menu Screen
(3) Press [ENTER] key. Auto Rinse and background check are performed.
NOTE: • On the Menu screen, each menu can be selected directly by entering a
numeral from the numeric keys.
*Auto Rinse*
Please wait.
Figure 4-7-2: Auto Rinse Execution Screen
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-25
NOTE: • After Auto Rinse, background check is executed. When the background
value of any parameter exceeds tolerance, background check is
repeated a maximum of twice. In case background value still exceeds
tolerance, the message "Background Error" appears while the alarm
starts sounding. Press [HELP] key. This stops the alarm and the
Action Message screen appears. Follow the Action Message screen
and take appropriate action. (Refer to Chapter 7:
TROUBLESHOOTING).
• Background tolerance
WBC 0.3 [×103
/µL] or less
RBC 0.02 [×106
/µL] or less
HGB 0.1 [g/dL] or less
PLT 10 [×103
/µL] or less
Table 4-7-1: Background tolerance
MAINTENANCE AND SUPPLIES REPLACEMENT
4-26 Sysmex KX-21N Operator’s Manual -- October 1999
7.2 Clean Rinse Cup
When the rinse cup has any blood on it or is clogged, clean it by the following procedure:
• When cleaning the rinse cup, always wear rubber gloves. After
completion of operation, wash hands with disinfectant. If your hands
are contaminated by blood, etc., infection of bacteria or the like can
occur.
(1) Turn off the power of the main unit and wait approximately 30 seconds.
(2) Open the front cover of the main unit.
(3) Gently push down the rinse cup using both hands. Make sure the rinse cup is
removed completely from the sample probe.
Sample Probe
Rinse Cup
Figure 4-7-3: Pushing Down the Rinse Cup
(4) Remove the rinse cup in the order of 1, 2, and 3 as shown below.
Rinse Cup
3
2
1
Figure 4-7-4: Removing the Rinse Cup
WARNING
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-27
(5) Clean the rinse cup using tap water.
Figure 4-7-5: Cleaning the Rinse Cup
(6) Make sure no contaminant remains on the rinse cup and wipe off water.
(7) Mount the rinse cup in the reverse order of removal. Route the thin tubes around the
rear of the rinse cup.
Rinse Cup
3
2
1
Figure 4-7-6: Mounting the Rinse Cup
(8) Gently push up the rinse cup to the top using both hands.
CAUTION: • Make sure the rinse cup is pushed all the way up with the sample
probe inserted in the hole. If the power is turned on with the rinse cup
staying lowered, "Rinse Motor Error" will occur, making it impossible to
continue the operation.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-28 Sysmex KX-21N Operator’s Manual -- October 1999
7.3 Clean WBC/RBC Transducer Aperture
If the transducer aperture clogging persists, clean the transducer aperture using the brush by
the following procedure:
• When cleaning the aperture, always wear rubber gloves. After
completion of operation, wash hands with disinfectant. If your hands
are contaminated by blood, etc., infection of bacteria or the like can
occur.
• Since CELLCLEAN is a strong alkaline detergent, take care not to have
it adhere to the skin or clothes. If the skin or clothes should come in
touch with it, flush it away using plenty of water. Otherwise, it can
damage the skin or clothes.
1 . Preparation
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Use [ ] key or [ ] key, move the cursor to select "7: Maintenance."
(3) Press [ENTER] key. The Maintenance Menu screen appears.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
Figure 4-7-7: Maintenance Menu Screen
(4) Use [ ] key or [ ] key, move the cursor to select "4: Drain TD Chamber."
(5) Press [ENTER] key. Reagent in the transducer chamber is automatically drained.
NOTE: • On the Menu screen, each menu can be selected directly by entering a
numeral from the numeric keys.
WARNING
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-29
(6) When reagent in the transducer chamber is drained, the message instructing turning-off
of the power is displayed, which indicates that it is ready for cleaning with the brush.
*Drain TD Chamber.*
3:Cancel
Fluid in T.D.Chamber was drained.
Turn power OFF and dab the aperture
with transducer brush.
See the Operator's Manual.
Figure 4-7-8: Drain TD Chamber Screen
NOTE: • When you press [3] key, cleaning with brush is canceled and the
Analysis screen returns.
2 . Clean Transducer Aperture
(1) Turn off the power and wait approximately 30 seconds.
(2) Open the front cover of the main unit.
(3) Loosen the screw and open the transducer cover.
Transducer Cover
Loosen
Screw
Figure 4-7-9: Opening the Transducer Cover
• When the power is on, never open the transducer cover. This is to
prevent possible electric shocks.
WARNING
MAINTENANCE AND SUPPLIES REPLACEMENT
4-30 Sysmex KX-21N Operator’s Manual -- October 1999
(4) Confirm that reagent in the transducer chamber has been drained.
RBC Transducer
WBC Transducer
Figure 4-7-10: Checking the WBC/RBC Transducer
(5) Remove the transducer chamber plug.
Plug
Figure 4-7-11: Removing the Plug
• A small volume of reagent occasionally remains. When reagent has
leaked, wipe it off immediately using wet cloth or the like. If left as it is, it
can cause current leakage or electric shocks.
(6) Apply CELLCLEAN on the brush provided, and dab by lightly prodding the brush
against the transducer aperture.
Brush
Aperture
Figure 4-7-12: Cleaning the Aperture
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-31
NOTE: • After using the brush, wash it in water thoroughly to remove
CELLCLEAN before storing it.
(7) Mount the transducer chamber plug.
• The transducer chamber plug should be mounted securely. Otherwise,
current leakage or electric shocks can occur.
(8) Close the transducer cover and main unit front cover. Then turn on the power.
(9) Check to see that background error has not occurred.
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
4-32 Sysmex KX-21N Operator’s Manual -- October 1999
7.4 Replace Waste Tank
When the waste tank has become full, replace it by the following procedure:
• When replacing the waste tank, always wear rubber gloves. After
replacing, wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria or the like can occur.
(1) Turn off the power of the main unit and wait approximately 30 seconds.
(2) Make ready an empty waste container and remove the cap.
(3) Pull the tube off the waste container.
(4) Insert the tube in the new waste container and fix it using tape or the like.
Tube
Waste
Tape
Figure 4-7-13: Waste Container
• When using a used reagent container as the waste container, make
sure to clearly mark it that it is the waste container.
WARNING
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-33
8 . SUPPLIES REPLACEMENT
8.1 Replenish Reagent
When reagent becomes insufficient during analysis, the instrument comes to a stop, while the
screen displays the error message. Press [HELP] key to change to the replenishment
operation.
Error
Message
(Analysis
Screen)
HELP Screen Reagent to
Replenish
Replenish
Diluent
*Help*
Replenish Diluent Container.
ERR CODE:XXXXX.X.X
Reaspirating Diluent[1]
1:Asp. Reag. 3:Cancel
CELLPACK
Replenish
Lyse
1:Asp.Reag.
ERR CODE:12490.0.0
*Help*
3:Cancel
Replenish Lyse Container.
Reaspirating Lyse[1]
STROMATOLYSER-WH
NOTE: • Press [3] key on the HELP screen and select "3: Cancel" to return to
the Analysis screen. Although Analysis screen displays the Not
Ready status, the processing, etc. of stored data can be performed.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-34 Sysmex KX-21N Operator’s Manual -- October 1999
(1) Make ready a new reagent and check to see that expiration date is not passed.
• CELLPACK, if used just after delivery via transit, sometimes develop a
background error.
• In handling a reagent that may have frozen, follow the precautions
given on the Package Insert. Otherwise, correct analysis result may
not be obtained.
• Leave the reagent at room temperature (15 - 30°C) for at least 24 hours
before using.
• After unpacking, take care to prevent entry of dirt, dust, and bacteria.
Table 4-8-1: Expiration After Opening the Seal
(2) Remove the cap from the new
reagent bottle.
(3) Remove the cap from the empty
reagent bottle and pull out the
cubitainer spout set straight up.
(4) Insert the cubitainer spout set
straight down into the new reagent
bottle and tighten the cap.
Figure 4-8-1: Pulling Out the Cubitainer
Spout Set
• Take care not to grasp the tube dipping into the reagent and not allow
dust, etc. to adhere to the tube. If dust, etc. adheres to the tube, wash
it away with reagent in use before mounting. Otherwise, correct
analysis results may not be obtained.
• Replace only fresh and fully bottled lyse reagent. Old or collected lyse
reagent will affect the analysis results.
• Take care not to spill reagent. If it spills, wipe it off immediately using
wet cloth, etc. to prevent the floor color fading.
• When replacing lyse, you do not need to disconnect the float switch. If
disconnected, connect it securely in prior to starting analysis. Starting
analysis with disconnected float switch will give you an error message
"No Lyse".
CAUTION
CAUTION
CELLPACK 20 L 60 days
STROMATOLYSER-WH 500 mL 90 days
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-35
(5) When reagent replenishment is over, follow the instruction on the screen and press [1]
key to select "1: Asp. Reag." Reagent is automatically aspirated, and then background
check is performed. The check is made here to see that background error has not
occurred.
(6) Enter the contents of replenishment in Reagent Replenishment Record.
NOTE: • If you replenish lyse before error message "No Reagent" appears,
execute "4: Replace Lyse" on the Select Menu screen.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-36 Sysmex KX-21N Operator’s Manual -- October 1999
8.2 Replace Fuse
The main unit employs overcurrent protective fuses. When a fuse is blown, replace it by the
following procedure:
(1) Disconnect the power cord on the right side of the main unit.
• Before replacing the fuse, always turn off the power and disconnect the
power cord to prevent possible electric shocks.
(2) Pressing the notch upward with a regular screwdriver, remove the fuse cap holder.
Fuse
Fuse Cap Holder Notch
Figure 4-8-2: Removing the Fuse Cap Holder
(3) Replace the fuse and mount the fuse cap holder.
Specification Part No. Description Fuse Type
117 VAC 266-5109-1 Fuse 250 V 3.15 A ST4-3.15A-N1 Time Lag
220/240 VAC 266-5292-6 Fuse 250 V 2 A No. 19195 Time Lag
Table 4-8-2: Fuse Rating
• For continued protection against risk of fire, use the fuse of the specified
type and rating.
WARNING
CAUTION
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-37
8.3 Replace Printer Paper
When the "IP paper empty" message appears on the screen, press [HELP] key and replace
printer paper of the built-in printer by the following procedure:
*Help*
IP paper empty
ERR CODE:XXXXX.X.X
Restarting to print
Stop printing on IP
[1]
[3]
To make IP on-line,
press [SELECT], then
[Periph. Settings]
1:Print 2:Paper Feed 3:Stop Output
Figure 4-8-3: "IP paper empty" Message Screen
NOTE: • On the HELP screen, press [3] and select "3: Stop Output" to stop
printing on built-in printer. Analysis is executed as usual but printing is
not. When you want to use built-in printer again, select "8: Periph.
Settings" to set. (Refer to Chapter 10, Section 11: Peripheral
Settings.)
(1) Open the front cover of the main unit.
(2) Turn the release lever up to free the paper.
Release Lever
Figure 4-8-4: Releasing the Lever
MAINTENANCE AND SUPPLIES REPLACEMENT
4-38 Sysmex KX-21N Operator’s Manual -- October 1999
(3) Remove the bare paper core and mount a new printer paper.
New Printer Paper
Figure 4-8-5: Mounting a New Printer Paper
NOTE: • When any printer paper remains, remove it together with the paper
core.
(4) Pass the printer paper as shown below, and turn the release lever down to secure.
Figure 4-8-6: Securing the Release Lever
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-39
(5) Cut off any printer paper extending from the upper part of the printer.
Figure 4-8-7: Cutting Off Paper
(6) Close the front cover of the main unit.
(7) Press [1] key and output any print data that is remaining on the memory.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-40 Sysmex KX-21N Operator’s Manual -- October 1999
8.4 Supplies List
1 . Reagents List
Product Code Product Name General Name
834-0161-8 CELLCLEAN (50 mL) Detergent
884-0871-1 CELLPACK (20 L) Diluent
974-0521-6 STROMATOLYSER-WH (500 mL × 3) WBC/HGB Lyse
Table 4-8-3: Reagents List
2 . Consumable List
Product Code Product Name Chapter & Section for Reference
933-3601-9 TRANSDUCER
BLUSH NO.1
Chapter 4, Section 7.3: Clean WBC/RBC
Transducer Aperture.
943-1781-1 CUBITAINER SPOUT
KIT NO. 1 (20 L)
Chapter 4, Section 8.1: Replace Reagent
(Replacement of spout kit is suggested if
background count will not drop when
diluent has been replaced.)
973-3041-7 FLOAT SWITCH NO.
23 ASSY
Chapter 4, Section 8.1: Replace Reagent
(Replacement of float switch is
suggested if WBC/HGB background
count will not drop when lyse has been
replaced.)
266-5292-6 FUSE 250 V, 2 A NO.
19195
Chapter 4, Section 8.2: Replace Fuse
(220/240 VAC Spec.)
266-5109-1 FUSE 250 V, 3.15 A
ST4-3.15A-N1
Chapter 4, Section 8.2: Replace Fuse
(117 VAC Spec.)
921-0351-8 PAPER THERMAL
F1-2
(5/BOX)
Chapter 4, Section 8.3: Replace Printer
Paper
(Heat-Sensitive Paper)
Table 4-8-4: Consumable List
NOTE: • If you need to order supplies or replacement parts, please contact your
local Sysmex representative.
Sysmex KX-21N Operator’s Manual -- Revised August 2001
MAINTENANCE AND SUPPLIES REPLACEMENT
Sysmex KX-21N Operator’s Manual -- October 1999 4-41
9 . CONFIRMATION OF CYCLE NUMBER
To let you know when to perform maintenance, this unit has the functions of cycle No.
display and automatic reset. As to the waste chamber, transducer, and sample rotor valve
(SRV), the next maintenance period is informed in accordance with the operation cycle No.
or date, whichever comes first.
Cleaning of waste chamber Every 2500 cycles or every month
Cleaning of transducer Every 2500 cycles or every month
Cleaning of sample rotor valve (SRV) Every 7500 cycles or every 3 months
Table 4-9-1: Maintenance Timing
Current cycle No. of each item can be checked by the following procedure:
9.1 Operation Procedure
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance."
(3) Press [ENTER] key. The Maintenance Menu screen appears.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
Figure 4-9-1: Maintenance Menu Screen
(4) Using [ ] key or [ ] key, move the cursor to select "5: Status Display."
(5) Press [ENTER] key. The Status Display screen 1 appears.
NOTE: • On the Menu screen, each menu can be selected directly by entering a
numeral from the numeric keys.
MAINTENANCE AND SUPPLIES REPLACEMENT
4-42 Sysmex KX-21N Operator’s Manual -- October 1999
(6) Using [ ] key or [ ] key, turn over the page to display the Status Display screen 2.
COUNTER 1234567
SRV 7567
DETECTOR 2567
WASTE CHAMBER 2567
WB
Ready
*Status*
Cycle No. after cleaning waste chamber
Cycle No. after cleaning transducer
Cycle No. after cleaning SRV
Change screen with [ ] or [ ].
Figure 4-9-2: Status Display Screen 2
NOTE: • Cycle number is the number of operations after the last maintenance.
• When the power is turn-on and the counter exceeds the predetermined
cycle number (or number of days), the message instructing the
maintenance is displayed on the screen. At this time, the cycle number
and the date of the last service are displayed.
1:Exec.Clean 3:Cancel
*Scheduled Maint.*
Clean the Waste Chamber.
It will take approx. 15 minutes.
Cycle No. after cleaning. 2515
Date last serviced 1/12/1999
Figure 4-9-3: Scheduled Maintenance Message Screen
Sysmex KX-21N Operator’s Manual -- October 1999
CHAPTER 5 QUALITY CONTROL
1. INTRODUCTION ................................................................. 5-1
1.1 X Control.................................................................... 5-1
1.2 Levy-Jennings Control (L-J) .............................................. 5-1
1.3 QC Chart Screen ............................................................ 5-2
2. QC ANALYSIS PROCEDURE.................................................. 5-4
2.1 QC Analysis Procedure Flow Chart ...................................... 5-4
2.2 Execute QC Program ....................................................... 5-5
2.3 Select QC File ............................................................... 5-6
2.4 Erase All...................................................................... 5-7
2.5 Set TARGET/LIMIT Values............................................... 5-8
2.6 Execute X Control .........................................................5-10
2.7 Execute L-J Control........................................................5-19
2.8 Exit from QC Control Program...........................................5-26
3. DELETION ........................................................................5-27
4. EXTERNAL OUTPUT ..........................................................5-31
4.1 Printing to Printer ..........................................................5-31
4.2 Output to Host Computer .................................................5-35
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-1
1 . INTRODUCTION
Quality Control checks are performed to monitor an instrument’s performance over time.
EIGHTCHECK-3WP is the quality control material recommended by Sysmex to monitor the
performance of the KX-21N analyzer. This product is supplied with three control levels, at
least two levels should be run every 8 hours of operation or in accordance to regulations
applicable to your laboratory. Quality control material should be run after component
replacement or after a service call. The KX-21N has two quality control methods.
1.1 X Control
In X control, control blood is analyzed twice and the mean of the two is used to evaluate
analyzer performance.
1.2 Levy-Jennings Control (L-J)
The L-J control uses the data from a single control blood analysis to evaluated analyzer
performance.
NOTE: • Selection of the one of the two methods can be performed using QC
method in the QC Settings program. Refer to "Chapter 10, Section 5:
QC Settings."
QUALITY CONTROL
5-2 Sysmex KX-21N Operator’s Manual -- October 1999
1.3 QC Chart Screen
When the QC program is executed, the QC File List screen appears first.
Six QC Files are displayed in the file list. Select the QC File used from among that, and
display the QC Chart screen.
The QC Chart can display QC data up to the latest 60 points. When a new data comes in, the
oldest data is erased.
The control parameters indicated in the QC Chart are displayed on multiple pages. [ ] key
or [ ] key can be used to change over the screen.
The Menu Display Area displays "1: QC Analyze," "2: Settings," and "3: Erase All." The
menu can be executed using the numeric keys.
P6. QC Chart Screen [6/8] P5. QC Chart Screen [5/8]P7. QC Chart Screen [7/8]
P4. QC Chart Screen [4/8]P8. QC Chart Screen [8/8]
P2. QC Chart Screen [2/8] P3. QC Chart Screen [3/8]P1. QC Chart Screen [1/8]
Figure 5-1-1: Page Selection in QC Chart Screen
(N=30) 31/10
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
FILE No.1 [1234567890][07/11/1999]
Line cursor
Exp.DateLot.No.
1:QC Analyze 2:Settings 3:Erase All
Figure 5-1-2: QC Chart Screen
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 5-3
The QC Chart screen displays QC data as shown below:
1 ) FILE No.
FILE No. of QC Chart displayed on the screen
2 ) Lot. No.
Lot number set in the QC File.
3 ) Exp. Data
Expiration date set in the QC File.
4 ) N
The number of control data plotted currently. In the case of X control, the average
represents a data.
5 ) Control parameter
Analysis parameters of control data are displayed on multiple pages:
QC Chart screen [1/8]: WBC, RBC, HGB
QC Chart screen [2/8]: HCT, MCV, MCH
QC Chart screen [3/8]: MCHC, PLT
QC Chart screen [4/8]: LYM%, MXD%, NEUT%
QC Chart screen [5/8]: LYM#, MXD#, NEUT#
QC Chart screen [6/8]: RDW-SD, RDW-CV
QC Chart screen [7/8]: MPV
QC Chart screen [8/8]: W-SMV, W-LMV
6 ) LIMIT (UL)
The upper control limit. An analysis value exceeding this limit is a QC error.
7 ) LIMIT (LL)
The lower control limit. An analysis value exceeding this limit is a QC error.
8 ) Target value
QC Target value
9 ) DATA
The QC data of the plot specified by the vertical line cursor. In the case of X control, it
is the mean value of two consecutive analyses.
10) MEAN
The mean of QC data plotted currently
11) Line Cursor
The vertical line cursor can be moved to the right or left using [ ] key or [ ] key.
The QC data of the plot shown by the line cursor, along with analysis date, are
displayed.
QUALITY CONTROL
5-4 Sysmex KX-21N Operator’s Manual -- October 1999
2 . QC ANALYSIS PROCEDURE
2.1 QC Analysis Procedure Flow Chart
Execute QC program
Select QC File
Page 5-5
Page 5-6
New QC
YES
NO
Erase All QC Data
Set TARGET Values/
LIMIT Values
Page 5-7
Page 5-8
Execute L-J ControlExecute X Control
Page 5-19Page 5-10
Exit from QC Program
Delete QC Data External Output
Page 5-27
Page 5-26
Page 5-31
Figure 5-2-1: QC Analysis Procedure Flow Chart
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-5
2.2 Execute QC Program
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "2: Quality Control."
(3) Press [ENTER] key. The QC File List screen appears.
1 :1 : [1234567890][07.11.1999]
2 : [1234567891][14.11.1999]
3 : [1234567892][21.11.1999]
4 : [1234567893][28.11.1999]
5 : [1234567894][01.12.1999]
6 : [1234567895][06.12.1999]
Lot.No. Exp.Date
*Quality Control*
Figure 5-2-2: QC File List screen
QUALITY CONTROL
5-6 Sysmex KX-21N Operator’s Manual -- October 1999
2.3 Select QC File
This instrument stores six QC Files. To execute QC analysis, settings, file erasing, or HC
output, display the QC Chart screen for a desired file as follows.
How to Select QC File
(1) Using [ ] key or [ ] key to move the cursor on the QC File List screen, and select a
QC file to be selected.
(2) Press [ENTER] key. The QC Chart screen for the selected QC file appears.
NOTE: • The QC File can be selected directly by inputting file number of the
QC File with numeric keys.
• Press [SELECT] key to return from the QC Chart screen to the QC File
List screen.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:QC Analyze 2:Settings 3:Erase All
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-2-3: QC Chart Screen
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-7
2.4 Erase All
To start quality control newly, the control data in the QC File has to be erased. When a
control blood lot has changed, use the menu of "3: Erase All" to erase all control data in the
QC File.
How to Erase All QC Data
(1) Display the QC Chart screen for the QC File you want to erase.
For how to select the QC File, refer to Section 2.3: Select QC File in this chapter.
(2) Press [3] key to select "3. Erase All." The Erase All Confirmation message appears.
OK to erase all? Yes No
Figure 5-2-4: Erase All Confirmation Message
(3) Using [ ] key or [ ] key, move the cursor to select "Yes" or "No."
[Yes]: Erases the plot display on the QC Chart screen and displays the second Erase
All Confirmation message.
[No]: Cancels the erasing of the plot display on the QC Chart screen and returns to
the QC Chart screen.
All are erasing. Execute Cancel
Figure 5-2-5: Second Erase All Confirmation Message
(4) Using [ ] key or [ ] key, move the cursor to select "Execute" or "Cancel."
[Execute]: Completely erases QC data and returns to the QC Chart screen.
[Cancel]: Cancels QC data erase and returns to the QC Chart screen.
(5) Press [ENTER] key to execute the selected process.
QUALITY CONTROL
5-8 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
2.5 Set TARGET/LIMIT Values
Before executing Quality Control anew, you have to set TARGET and LIMIT values for the
QC File using "2: Settings" on the menu. Also, the lot number and the expiration date of the
control blood can be registered at the same time as setting these.
How to Set QC File
(1) Display the QC Chart screen for the QC File you want to set.
For how to select the QC File, refer to Section 2.3: Select QC File in this chapter.
(2) Press [2] key to select "2: Settings."
The QC File Setting screen appears.
FILE No.1
TARGET LIMIT
WBC 0.0 0.0 ×103
/µL
RBC 0.00 0.00 ×106
/µL
HGB 0.0 0.0 g/dL
HCT 0.0 0.0 %
MCV 0.0 0.0 fL
MCH 0.0 0.0 pg
MCHC 0.0 0.0 g/dL
PLT 0 0 ×103
/µL
Lot.No [ ]
Exp.Date [ ]
Press [SELECT] to exit.
Figure 5-2-6: QC File Setting Screen
(3) Move the cursor with [ ] key or [ ] key, and select Lot.No. (lot number), Exp.Date
(expiration date) or the control parameter.
Move the cursor with [ ] key or [ ] key, and select TARGET or LIMIT in the
control parameter.
NOTE: • There are 19 control parameters, but all the control parameters cannot
be listed in one screen, so scroll the screen with [ ] key or [ ] key.
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-9
(4) Enter the set values using the numeric keys.
NOTE: • Each time you press [C] key in the middle of entering, one character
disappears and the cursor moves to the left.
For setting the lot number
• The Lot number can be input up to 10 digits.
• Also, the lot number can be input with the hand held barcode reader
(option).
For setting the expiration date
• The expiration date can be input up to 10 digits.
• Even if the expiration date is input, processing which judging the date
in the program is not carried out.
This is just a memo input for managing the QC File.
For setting the control parameter
• As a set value, up to five digits including decimal point can be entered.
• The decimal point position is linked to the Unit System established in
System Setup. For detail, refer to Chapter 10: INSTRUMENT
SETTING, Section 2: System Setup.
(5) Press [ENTER] key.
The contents of settings are set and the cursor moves to the next item.
NOTE: • The contents of settings are also set when [ ] key, [ ] key, [ ] key,
or [ ] key is pressed after entering.
(6) When settings are completed, press [SELECT] key. The Setting Confirmation
message appears.
OK to set? Cont. Set Cancel
Figure 5-2-7: Setting Confirmation Message
(7) Using [ ] key or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the QC File Setting screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the QC Chart screen.
[Cancel]: Cancels the changed settings and returns to the QC Chart screen.
(8) Press [ENTER] key to execute the selected process.
NOTE: • QC chart will be drawn only if the TARGET and LIMIT values are both
entered appropriately.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
QUALITY CONTROL
5-10 Sysmex KX-21N Operator’s Manual -- October 1999
2.6 Execute X Control
The X control method for analyzing control blood is described here.
(1) Display the QC Chart screen for the QC File in which to enter QC data. For how to
select the QC File, refer to Chapter 2.3: Select QC File in this chapter.
NOTE: • QC analysis is executed by control method (X control or L-J control)
set in QC Settings. For setting procedures, refer to Chapter 10,
Section 5: QC Settings.
• While the X Control Analysis screen is displayed, the QC File cannot
be changed.
(2) Press [1] key to select "1: QC Analyze." The X Control Analysis screen appears.
FILE No.1 QC
X1 X2 X Judgement
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
Ready
Figure 5-2-8: X Control Analysis Screen
NOTE: • QC analysis is made in the whole blood mode. When the pre-diluted
mode is selected as analysis mode, the Mode Change Sequence is
activated to change over to the whole blood mode.
(3) Confirm that "Ready" is displayed for QC analysis.
• In analyzing control blood, always wear rubber gloves. After
completion of work, wash the hands with disinfectant. If your hands
are contaminated by blood, etc., infection of pathogenic bacteria can
occur.
WARNING
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-11
(4) Mix control blood according to the package insert.
Figure 5-2-9: Mixing the Control Blood
(5) Remove the cap while taking care not to allow blood to scatter.
Figure 5-2-10: Removing the Cap
(6) Set the control blood container to the sample probe and press the start switch in that
status.
Start switch
Figure 5-2-11: Pressing the Start Switch
(7) When the buzzer sounds two times - beep, beep, - and "Analyzing" is displayed on the
X Control Analysis screen, remove the control blood container. Then, automatic
analysis is executed.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
QUALITY CONTROL
5-12 Sysmex KX-21N Operator’s Manual -- October 1999
The screens from the start to the end of analysis are as shown below.
(Ready)
FILE No.1 QC
Ready
(Aspirating)
Aspirating
FILE No.1 QC
(Analyzing)
Analyzing
FILE No.1 QC
(Rinsing)
Rinsing
FILE No.1 QC
Figure 5-2-12: X Control Analysis Screen
• While the screen is displaying "Aspirating," keep holding the control
blood container in the aforementioned status. If the container is
removed during its display, correct analysis may not be obtained.
CAUTION: • Several seconds after the buzzer sounds "beep, beep" and
"Analyzing" appears on the screen, the rinse cup lowers. Remove the
control blood container by that time.
• To remove the container, lower it straight down. Take care not to bend
the sample probe.
NOTE: • The sample probe is automatically rinsed, so there is no need to wipe it
clean.
CAUTION
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 5-13
(8) Under the "X1" column on the Analysis Result screen, the 1st time analysis result is
displayed.
The analysis result comprises three screens which can be changed over by pressing
[ ] key or [ ] key.
P2. WBC Screen P3. RBC/PLT ScreenP1. CBC8 Parameter Screen
Figure 5-2-13: Page Selection in QC Analysis Result Screen
FILE No.1 QCQC
X1 X2 X Judgement
WBC 7.3
RBC 4.52
HGB 14.8
HCT 36.2
MCV 80.1
MCH 32.7
MCHC 40.9
PLT 206
Accept Data?
1:OK 2:NG 3:Print
Figure 5-2-14: P1. CBC8 Parameter Screen
Accept Data?
1:OK 2:NG 3:Print
31/12 10:02No.QC01-1
W-LMV 172.4fL
W-SMV 56.3fL
NEUT# 4.3×103
/µL
WBC
MXD# 1.0×103
/µL
LYM# 2.0×103
/µL
NEUT% 59.4%
MXD% 13.4%
LYM% 27.2%
WBC 7.3×103
/µL
FILE No.1 QC
Figure 5-2-15: P2. WBC Screen
Accept Data?
1:OK 2:NG 3:Print
31/10 10:02No.QC01-1
P-LCR 14.8%
MPV 9.1fL
PDW 8.3fL
RBC
PLT
PLT 206×103
/µL
RDW-CV 11.4%
RDW-SD 27.4fL
MCV 80.1fL
RBC 4.52×106
/µL
FILE No.1 QCQC
Figure 5-2-16: P3. RBC/PLT Screen
QUALITY CONTROL
5-14 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
If the data is acceptable, press [1] key to confirm. Press [2] key to reject.
Press [3] key and select "3: Print" to print the contents of analysis result on the built-in
printer.
WBC
[fl]
RBC
[fl]
PLT
[fl]
No. QC01-1
Date 31/10/1999
Time 10:02
Mode QC
WBC 7.3 ×103
/µL
RBC 4.52 ×106
/µL
HGB 14.8 g/dL
HCT 36.2 %
MCV 80.1 fL
MCH 32.7 Pg
MCHC 40.9 g/dL
PLT 206 ×103
/µL
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103
/µL
MXD# 1.0 ×103
/µL
NEUT# 4.3 ×103
/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RDW-SD 27.4 fL
RDW-CV 11.4 %
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
Figure 5-2-17: Example of Analysis Result Printing
NOTE: • Print of analysis result is valid until the data is set. If the data is set by
pressing [1] key or [2] key, analysis result cannot be printed.
• This print format cannot be changed since it is the special format for QC
analysis.
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-15
(9) Set the data using [1] key or [2] key.
[1: OK]: Accepts analysis result as the 1st time QC data. And the system turns to be
ready for the 2nd analysis.
[2: NG]: Cancels the 1st time analysis result. And the system remains to be ready for
another 1st time analysis.
CAUTION: • When an error occurs during QC analysis, error message is displayed
in the system status area.
Press [HELP] key and perform the error recovery process. For the error
recovery process, refer to Chapter 7: TROUBLESHOOTING.
When you press [SELECT] key before setting the 1st QC data, the QC Cancel
Confirmation message is displayed.
OK to cancel? Yes No
Figure 5-2-18: QC Cancel Confirmation Message
Using [ ] key or [ ] key, move the cursor to select "Yes" or "No."
[Yes]: Rejects analysis result, exits from QC program, and returns to the Analysis
screen.
[No]: Returns to the QC Analysis screen and allows continuous QC analysis.
Press [ENTER] key to execute the selected process.
(10) When the 1st analysis data is accepted, the (3) - (7) procedure is repeated for the 2nd
analysis.
(11) The 2nd analysis result is displayed under "X2" on the Analysis Result screen, the
mean values of the 1st and the 2nd analyses under "X," and the comparison result with
control limits under the "Judgment" column.
The Analysis Result screen, as in the 1st analysis, can be changed over using [ ] key
or [ ] key.
The data confirmation message is displayed and you are asked to decide whether or not
to accept the analysis result as QC data.
QUALITY CONTROL
5-16 Sysmex KX-21N Operator’s Manual -- October 1999
Accept Data?
1:OK 2:NG 3:Print
FILE No.1 QC
X1 X2 X Judgement
WBC 7.3 7.5 7.4
RBC 4.52 4.49 4.51
HGB 14.8 14.7 14.8
HCT 36.2 35.6 35.9
MCV 80.1 79.3 79.7
MCH 32.7 32.7 32.7
MCHC 40.9 41.3 41.1
PLT 206 209 208
Figure 5-2-19: Analysis Result Screen
A parameters in which the mean of the 1st and the 2nd analyses fell outside the control
limits is indicated with + or − under the "Judgment" column, while the alarm sounds
and the QC error message appears.
X1 X2 X Judgement
WBC 7.3 7.5 7.4
RBC 4.52 4.49 4.51
HGB 14.8 14.7 14.8
HCT 42.5 43.0 42.8 +
MCV 94.0 95.8 94.9 +
MCH 32.7 32.7 32.7
MCHC 34.8 34.1 34.5 -
PLT 106 109 108 -
FILE No.1 QC QC Error
Accept Data?
1:OK 2:NG 3:Print
Figure 5-2-20: QC Error Message Screen
(12) Set the data using [1] key or [2] key.
[1: OK]: QC data is accepted and the plot is entered to the QC Chart. This QC data
(mean) is kept in the stored data also.
[2: NG]: Cancels the 2nd analysis result. And the system remains to be ready for the
2nd analysis again.
CAUTION: • When an error occurs during QC analysis, the error message appears
in the system status area.
Press [HELP] key and perform the error recovery process. For the error
recovery process, refer to Chapter 7: TROUBLESHOOTING.
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 5-17
(13) The set data (mean) is printed on the built-in printer.
No. QC01-1
Date 31/10/1999
Time 10:02
Mode QC
WBC 7.4 ×103
/µL
RBC 4.51 ×106
/µL
HGB 14.8 g/dL
HCT 35.9 %
MCV 79.7 fL
MCH 32.7 Pg
MCHC 41.1 g/dL
PLT 208 ×103
/µL
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103
/µL
MXD# 1.0 ×103
/µL
NEUT# 4.3 ×103
/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RDW-SD 27.4 fL
RDW-CV 11.4 %
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
Figure 5-2-21: Example of Printing
NOTE: • Printing in QC settings is valid only when the "Built-in Printer" is
selected. For detail, refer to Chapter 10, Section 5: QC Settings.
• This print format cannot be changed since it is the special format for QC
analysis.
(14) The set data (mean) is output to the host computer.
NOTE: • Transmission to the host is valid only when the "Host Output" is
selected. For detail, refer to Chapter 10, Section 5: QC Settings.
• As to the host output format, refer to Appendix B: Technical Information.
QUALITY CONTROL
5-18 Sysmex KX-21N Operator’s Manual -- October 1999
When you press [SELECT] key before setting the 2nd QC data, the QC Cancel
Confirmation message appears.
OK to cancel? Yes No
Figure 5-2-22: QC Cancel Confirmation Message
Using [ ] key or [ ] key, move the cursor to select "Yes" or "No."
[Yes]: Rejects analysis result, exists from the QC program, and returns to the Analysis
screen.
[No]: Returns to the QC Analysis screen and allows continuous QC analysis.
Press [ENTER] key to execute the selected process.
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-19
2.7 Execute L-J Control
How to analyze control blood by L-J control is described here.
(1) Display the QC Chart screen for the QC File in which to enter QC data. For how to
select the QC File, refer to Chapter 2.3: Select QC File in this chapter.
NOTE: • QC analysis is executed by control method (X control or L-J control)
set in QC Settings. For setting procedures, refer to Chapter 10,
Section 5: QC Settings.
• While the L-J Control Analysis screen is displayed, the QC File cannot
be changed.
(2) Press [1] key to select "1: QC Analyze." The L-J Control Analysis screen appears.
FILE No.1 QC
Data Judgement
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
Ready
Figure 5-2-23: L-J Control Analysis Screen
NOTE: • QC analysis is made in the whole blood mode. When the pre-diluted
mode is selected as analysis mode, the Mode Change Sequence is
activated to change over to the whole blood mode.
(3) Confirm that "Ready" is displayed for QC analysis.
• In analyzing control blood, always wear rubber gloves. After
completion of work, wash the hands with disinfectant. If your hands
are contaminated by blood, etc., infection of pathogenic bacteria can
occur.
WARNING
QUALITY CONTROL
5-20 Sysmex KX-21N Operator’s Manual -- October 1999
(4) Mix control blood according to the package insert.
Figure 5-2-24: Mixing the Control Blood
(5) Remove the cap while taking care not to allow blood to scatter.
Figure 5-2-25: Removing the Cap
(6) Set the control blood container to the sample probe and press the start switch in that
status.
Start switch
Figure 5-2-26: Pressing the Start Switch
(7) When the buzzer sounds two times - beep, beep, - and "Analyzing" is displayed on the
L-JControl Analysis screen, remove the control blood container. Then, automatic
analysis is executed.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-21
The screens from the start to the end of analysis are as shown below.
(Ready)
FILE No.1 QC
Ready
(Aspirating)
Aspirating
FILE No.1 QC
(Analyzing)
Analyzing
FILE No.1 QC
(Rinsing)
Rinsing
FILE No.1 QC
Figure 5-2-27: L-J Control Analysis Screen
• While the screen is displaying "Aspirating," keep holding the control
blood container in the aforementioned status. If the container is
removed during its display, correct analysis may not be obtained.
CAUTION: • Several seconds after the buzzer sounds "beep, beep" and
"Analyzing" appears on the screen, the rinse cup lowers. Remove the
control blood container by that time.
• To remove the container, lower it straight down. Take care not to bend
the sample probe.
NOTE: • The sample probe is automatically rinsed, so there is no need to wipe it
clean.
CAUTION
QUALITY CONTROL
5-22 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
(8) Analysis result is given under the "Data" column on the Analysis Result screen and
comparison result with QC limits under the "Judgment" column.
The analysis result comprises three screens which can be changed over by pressing
[ ] key or [ ] key.
P2. WBC Screen P3. RBC/PLT ScreenP1. CBC8 Parameter Screen
Figure 5-2-28: Page Selection in QC Analysis Result Screen
Data Judgement
WBC 7.3
RBC 4.52
HGB 14.8
HCT 36.2
MCV 80.1
MCH 32.7
MCHC 40.9
PLT 206
FILE No.1 QC
Accept Data?
1:OK 2:NG 3:Print
Figure 5-2-29: P1. CBC8 Parameter Screen
Accept Data?
1:OK 2:NG 3:Print
31/10 10:02No.QC01-1
W-LMV 172.4fL
W-SMV 56.3fL
NEUT# 4.3×103
/µL
WBC
MXD# 1.0×103
/µL
LYM# 2.0×103
/µL
NEUT% 59.4%
MXD% 13.4%
LYM% 27.2%
WBC 7.3×103
/µL
FILE No.1 QC
Figure 5-2-30: P2. WBC Screen
Accept Data?
1:OK 2:NG 3:Print
31/10 10:02No.QC01-1
P-LCR 14.8%
MPV 9.1fL
PDW 8.3fL
RBC
PLT
PLT 206×103
/µL
RDW-CV 11.4%
RDW-SD 27.4fL
MCV 80.1fL
RBC 4.52×106
/µL
FILE No.1 QCQC
Figure 5-2-31: P3. RBC/PLT Screen
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-23
As to those parameters whose analysis fell beyond control limits, + or − is displayed
under the "Judgment" column, while the alarm sounds with the QC error message
displayed.
Accept Data?
1:OK 2:NG 3:Print
Data Judgement
WBC 7.5
RBC 4.49
HGB 14.7
HCT 43.0 +
MCV 95.6 +
MCH 32.7
MCHC 34.1 -
PLT 109 -
FILE No.1 QC QC Error
Figure 5-2-32: QC Error Message Screen
If the data is acceptable, press [1] key to confirm. Press [2] key to reject.
Press [3] key and select "3: Print" to print the contents of analysis result on the built-in
printer.
QUALITY CONTROL
5-24 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
WBC
[fl]
RBC
[fl]
PLT
[fl]
No. QC01-1
Date 31/10/1999
Time 10:02
Mode QC
WBC 7.3 ×103
/µL
RBC 4.52 ×106
/µL
HGB 14.8 g/dL
HCT 36.2 %
MCV 80.1 fL
MCH 32.7 Pg
MCHC 40.9 g/dL
PLT 206 ×103
/µL
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103
/µL
MXD# 1.0 ×103
/µL
NEUT# 4.3 ×103
/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RDW-SD 27.4 fL
RDW-CV 11.4 %
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
Figure 5-2-33: Example of Analysis Result Printing
CAUTION: • Print of analysis result is valid until the data is set. If the data is set by
pressing [1] key or [2] key, analysis result cannot be printed.
• This print format cannot be changed since it is the special format for QC
analysis.
(9) Set the data using [1] key or [2] key.
[1: OK]: Sets QC data, and the plot is entered to the QC Chart. This QC data is kept
in the stored data.
[2: NG]: Cancels the analysis result, and the system remains to be ready for another
analysis .
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 5-25
CAUTION: • When an error occurs during QC analysis, error message is displayed
in the system status area.
Press [HELP] key and perform the error recovery process. For the error
recovery process, refer to Chapter 7: TROUBLESHOOTING.
(10) The set data is printed on the built-in printer.
No. QC01-1
Date 31/10/1999
Time 10:02
Mode QC
WBC 7.4 ×103
/µL
RBC 4.51 ×106
/µL
HGB 14.8 g/dL
HCT 35.9 %
MCV 79.7 fL
MCH 32.7 Pg
MCHC 41.1 g/dL
PLT 208 ×103
/µL
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103
/µL
MXD# 1.0 ×103
/µL
NEUT# 4.3 ×103
/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RDW-SD 27.4 fL
RDW-CV 11.4 %
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
Figure 5-2-34: Example of Printing
NOTE: • Printing in QC settings is valid only when the "Built-in Printer" is
selected. For detail, refer to Chapter 10, Section 5: QC Settings.
• This print format cannot be changed since it is the special format for QC
analysis.
(11) The set data is output to the host computer.
NOTE: • Transmission to the host is valid only when the "Host Output" is
selected. For detail, refer to Chapter 10, Section 5: QC Settings.
• As to the host output format, refer to Appendix B: Technical Information.
QUALITY CONTROL
5-26 Sysmex KX-21N Operator’s Manual -- October 1999
When you press [SELECT] key before setting the QC data, the QC Cancel
Confirmation message appears.
OK to cancel? Yes No
Figure 5-2-35: QC Cancel Confirmation Message
Using [ ] key or [ ] key, move the cursor to select "Yes" or "No."
[Yes]: Rejects analysis result, exist from the QC program, and returns to the Analysis
screen.
[No]: Returns to the QC Analysis screen and allows continuous QC analysis.
Press [ENTER] key to execute the selected process.
2.8 Exit from QC Control Program
(1) Press [SELECT] key on the QC Chart screen. The QC File List screen returns.
(2) Press [SELECT] key. The Analysis screen returns.
NOTE: • The sample No. and analysis mode on the Analysis screen return to
those displayed before execution of the QC program.
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-27
3 . DELETION
This menu can delete one data or the range specified data of QC data in the line cursor
position.
How to delete QC Data (Deletion only of one data)
(1) Display the QC Chart screen of QC file that contains the data you want to delete.
For how to select QC file, refer to Chapter 2.3: Select QC File in this chapter.
(2) Using [ ] key or [ ] key, move the line cursor to the position of the data to be
deleted.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:QC Analyze 2:Settings 3:Erase All
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-3-1: QC Chart Screen
(3) Press [ENTER] key.
The line cursor changes from dotted line to solid line, and the menu in the Menu
Display Area changes over to "1: Delete," "2: Output," "3: RangeSpec.".
NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the
menu in the Menu Display Area change to the original status.
• The line cursor that has changed to solid line cannot be moved.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:Delete 2:Output 3:RangeSpec.
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-3-2: QC Chart Screen (At Data Selection)
QUALITY CONTROL
5-28 Sysmex KX-21N Operator’s Manual -- October 1999
(4) Press [1] key to select "1: Delete."
The Deletion confirmation message appears.
OK to Delete? Yes No
Figure 5-3-3: Deletion Confirmation Message
(5) Using [ ] key or [ ] key, move the cursor to select "Yes" or "No."
[Yes]: Deletes QC data of the plot shown by the line cursor and returns the line cursor
to the dotted line.
[No]: Cancels deletion of QC data and returns the line cursor to the dotted line.
(6) Press [ENTER] key to execute the selected process.
How to delete QC Data (Deletion of range specified data)
(1) Display the QC Chart screen of QC file that contains the data you want to delete.
For how to select QC file, refer to Chapter 2.3: Select QC File in this chapter.
(2) Using [ ] key or [ ] key, move the line cursor to the end of the data within the
deleted range.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:QC Analyze 2:Settings 3:Erase All
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-3-4: QC Chart Screen
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-29
(3) Press [ENTER] key.
The line cursor changes from dotted line to solid line, and the menu in the Menu
Display Area changes over to "1: Delete," "2: Output," "3: RangeSpec.".
NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the
menu in the Menu Display Area change to the original status.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:Delete 2:Output 3:RangeSpec.
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-3-5: QC Chart Screen (At Data Selection)
(4) Press [3] key to select "3: RangeSpec.".
Move the line cursor of the dotted line for range specification of the other end.
(5) Using [ ] key or [ ] key, move the line cursor to the other end of the data within the
deleted range.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:Delete 2:Output 3:RangeSpec.
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-3-6: QC Chart Screen (At Data Range Specification)
(6) Press [ENTER] key.
The line cursor changes from dotted line to solid line.
QUALITY CONTROL
5-30 Sysmex KX-21N Operator’s Manual -- October 1999
(7) Press [1] key to select "1: Delete."
The Deletion confirmation message appears.
OK to Delete? Yes No
Figure 5-3-7: Deletion Confirmation Message
(8) Using [ ] key or [ ] key, move the cursor to select "Yes" or "No."
[Yes]: Deletes QC data of the plot shown by two line cursors and returns the line
cursor to the dotted line.
[No]: Cancels deletion of QC data and returns the line cursor to the dotted line.
(9) Press [ENTER] key to execute the selected process.
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-31
4 . EXTERNAL OUTPUT
Using this menu, QC data in the line cursor position can be printed out from the built-
in/external printer or output to the host computer. (The external printer is an option).
4.1 Printing to Printer
How to print QC Data
(1) Display the QC Chart screen of QC file that contains the data you want to print.
For how to select QC file, refer to Chapter 2.3: Select QC File in this chapter.
(2) Using [ ] key or [ ] key, move the line cursor to the position of the data to be
printed.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:QC Analyze 2:Settings 3:Erase All
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-4-1: QC Chart Screen
QUALITY CONTROL
5-32 Sysmex KX-21N Operator’s Manual -- October 1999
(3) Press [ENTER] key.
The line cursor changes from dotted line to solid line, and the menu in the Menu
Display Area changes over to "1: Delete," "2: Output," "3: RangeSpec.".
NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the
menu in the Menu Display Area change to the original status.
• The line cursor that has changed to solid line cannot be moved.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:Delete 2:Output 3:RangeSpec.
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-4-2: QC Chart Screen (At Data Selection)
(4) Press [3] key to select "3: RangeSpec.".
Move the line cursor of the dotted line for range specification of the other end.
(5) Using [ ] key or [ ] key, move the line cursor to the other end of the data within the
printing range.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:Delete 2:Output 3:RangeSpec.
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-4-3: QC Chart Screen (At Data Range Specification)
(6) Press [ENTER] key.
The line cursor changes from dotted line to solid line.
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-33
(7) Press [2] key to select "2: Output."
The pop-up menu to select the output destination will appear.
1 : H o s t
2 : D P
3 : G P
4 : L P
5 : I P
6 : I P F e e d
7:StopOutput
Figure 5-4-4: Pop-up Menu
(8) Using [ ] key or [ ] key to move the cursor to the desired printer, and press
[ENTER] key.
[1: Host]: Output the data to the host computer. Refer to 4.2: Output to Host
Computer in this chapter.
[2: DP]: This cannot be selected.
[3: GP]: The graphic printer starts graphic printing the QC data of the plot
which the line cursor shows.
[4: LP]: The graphic printer starts list printing the QC data of the plot which
the line cursor shows.
[5: IP]: The built-in printer starts printing the QC data of the plot which the
line cursor shows.
[6: IP Feed]: Carries out the paper feed of the built-in printer.
[7: StopOutput]: When two or more analysis data are output, this can be selected, and
the output will be interrupted when you select this.
When the print to the printer is completed, the line cursor returns to the dotted line, and
the menus of the menu display area returns to "1: QC Analyze", "2: Settings" and "3:
Erase All."
Contents of Printing
Contents of print with built-in printer
No. QC01-01
Date 31/10/1999
Time 10:02
Mode QC
WBC 7.3 ×103
/µL
RBC 4.52 ×106
/µL
HGB 14.8 g/dL
HCT 36.2 %
MCV 80.1 fL
MCH 32.7 Pg
MCHC 40.9 g/dL
PLT 206 ×103
/µL
Time Analyzed
Analysis Mode
Date Analyzed
File No.
Figure 5-4-5: Contents of print with built-in printer
Sysmex KX-21N Operator’s Manual -- Revised February 2000
QUALITY CONTROL
5-34 Sysmex KX-21N Operator’s Manual -- October 1999
Contents of graphic print with graphic printer
....
Print Date 31/10/1999
Print Time 10:26
File No.1
7/10/1999 - 30/10/1999(N=60)
WBC
Target/Limit
8.1
7.6 7.8 7.3 0
7.1
Mean SD CV%
Lot.No.[1234567890] Exp.Date[07.11.1999]
page( 1)
PBC
4.70
4.50 4.55 4.52 0
4.30
HGB
15.5
15.0 15.0 14.8 0
14.0
UL
LL
UL
LL
UL
LL
Figure 5-4-6: Contents of graphic print with graphic printer
Contents of list print with graphic printer
This is printed by the same format as the stored data list print.
Refer to Chapter 3, Section 3.4: External Output.
1 ) File No.
File No. of QC file is printed.
2 ) Analysis Mode
In the case of QC data, "QC" is printed.
3 ) Date/Time Analyzed
Printed is the date and time when analysis result was obtained.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-35
4.2 Output to Host Computer
Using this menu, QC data in the line cursor position can be output to the host computer
(option).
How to output QC Data to HC
(1) Display the QC Chart screen of QC file that contains the data you want to output to the
host computer.
For how to select QC file, refer to Chapter 2.3: Select QC File in this chapter.
(2) Using [ ] key or [ ] key, move the line cursor to the position of the data you want
to output to HC.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:QC Analyze 2:Settings 3:Erase All
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-4-7: QC Chart Screen
QUALITY CONTROL
5-36 Sysmex KX-21N Operator’s Manual -- October 1999
(3) Press [ENTER] key.
The line cursor changes from dotted line to solid line, and the menu in the Menu
Display Area changes over to "1: Delete," "2: Output," "3: RangeSpec.".
NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the
menu in the Menu Display Area change to the original status.
• The line cursor that has changed to solid line cannot be moved.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:Delete 2:Output 3:RangeSpec.
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-4-8: QC Chart Screen (At Data Selection)
(4) Press [3] key to select "3: RangeSpec.".
Move the line cursor of the dotted line for range specification of the other end.
(5) Using [ ] key or [ ] key, move the line cursor to the other end of the data within the
output range.
(N=30)
UL
WBC
RBC
HGB
LL
UL
LL
UL
LL
FILE No.1 [1234567890][07/11/1999]
31/10
1:Delete 2:Output 3:RangeSpec.
LIMIT DATA
(MEAN)
8.1
7.6 7.3
7.1( 7.8)
4.70
4.50 4.52
4.30( 4.55)
15.5
15.0 14.8
14.5( 15.0)
Figure 5-4-9: QC Chart Screen (At Data Range Specification)
(6) Press [ENTER] key.
The line cursor changes from dotted line to solid line.
QUALITY CONTROL
Sysmex KX-21N Operator’s Manual -- October 1999 5-37
(7) Press [2] key to select "2: Output."
The pop-up menu to select the output destination will appear.
1 : H o s t
2 : D P
3 : G P
4 : L P
5 : I P
6 : I P F e e d
7:StopOutput
Figure 5-4-10: Pop-up Menu
(8) Using [ ] key or [ ] key to move the cursor to [1: Host], and press [ENTER] key.
QC data of the plot shown by the line cursor is output to the host computer.
NOTE: • For the output format, refer to Appendix B: Technical Information.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
CHAPTER 6 CALIBRATION
1. INTRODUCTION ................................................................. 6-1
1.1 Calibration ................................................................... 6-1
1.2 Calibrator Calibration Program............................................ 6-1
2. PREPARATION FOR CALIBRATION ........................................ 6-2
2.1 Precision Check ............................................................. 6-2
2.2 Precision Check Sample.................................................... 6-2
2.3 HGB/HCT Calibration Samples........................................... 6-3
2.4 Reference Values............................................................ 6-3
2.4.1 Calibrator Calibration.............................................. 6-3
2.4.2 HGB/HCT Calibration ............................................ 6-3
2.5 Calibration Flow Chart ..................................................... 6-4
3. AUTOMATIC CALIBRATION.................................................. 6-5
3.1 Executing Automatic Calibration Program ............................... 6-5
3.2 Automatic Calibration Procedure.......................................... 6-6
4. MANUAL CALIBRATION .....................................................6-11
4.1 Calculating Calibration Value.............................................6-11
4.2 Manual Calibration Procedure ............................................6-12
5. CALIBRATOR CALIBRATION ...............................................6-15
5.1 Executing Calibrator Calibration Program ..............................6-15
5.2 Calibrator Calibration Procedure .........................................6-17
6. CALIBRATION HISTORY PRINT............................................6-25
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-1
1 . INTRODUCTION
Upon installation of the KX-21N, the Sysmex trained service representative will perform
instrument calibration. Calibration is required at installation, and then calibration is verified
at least daily with QC material.
This chapter covers procedures necessary to calibrate the instrument for WBC (white blood
cell count), RBC (red blood cell count), HGB (hemoglobin), HCT (hematocrit) and PLT
(platelet count). WBC differential parameters are calibrated at the factory prior to shipment
and are verified by the Sysmex representative at installation. They do not need to be
calibrated at the laboratory.
1.1 Calibration
It is recommended that the laboratory performs calibration when any of the following occurs:
• Major preventative maintenance has been performed or critical parts replaced such as
manometers apertures or detector circuit boards.
• Controls that reflect an unusual trend or are outside of acceptable limits, and cannot be
corrected by maintenance or troubleshooting the instrument.
• The Sysmex trained service representative has advised to calibration.
1.2 Calibrator Calibration Program
Calibrate the WBC, RBC, HGB, HCT and PLT of the KX-21N using the SCS-1000
calibrator. The calibration program consists of the following two functions.
(1) Precision Check
Using fresh human blood, the instrument reproducibility is checked against
manufacturer's specifications for precision.
(2) Calibration
Using the SCS-1000 calibrator, the instrument calibration is checked and recalibration
is performed as required.
NOTE: • Do not use EIGHTCHECK-3WP for calibration. It is used for quality
control. Calibration should be performed at the room temperature within
25±5°C.
CALIBRATION
6-2 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
2 . PREPARATION FOR CALIBRATION
2.1 Precision Check
Analyze a fresh human blood 11 times consecutively in the whole blood mode.
The system program automatically discards the first analysis and calculates the precision
(reproducibility) with the remaining 10 data.
The following has to be verified prior to starting the precision check:
• Transducer apertures are clog free. If not, perform the aperture cleaning procedures by
referring to Chapter 4.
• Check if the reagent volume in each reagent container is enough to complete the
calibration procedure.
• Check if the reagent is within the expiration date.
• If a waste container is used, check if the waste container has enough room to complete
the calibration procedure.
• Check if the background values fall within the following ranges;
WBC ≤ 0.3 x 103/µL
RBC ≤ 0.02 x 106/µL
HGB ≤ 0.1 g/dL
PLT ≤ 10 x 103/µL
2.2 Precision Check Sample
One sample of fresh normal whole blood should be used for the precision check. The
sample should be analyzed within six hours of collection and stored at room temperature.
Observe the following recommendations when selecting blood for precision check purposes.
• The sample should be collected from a person who is not on medication.
• The sample should be morphologically and numerically normal, as;
WBC ≥ 4.00 x 103/µL
RBC ≥ 4.00 x 106/µL
PLT ≥ 100 x 103/µL
• Lipemic, icteric, and hemolyzed specimens must be avoided.
• The anticoagulant should be the proper type and in proportion with the sample.
• The volume of whole blood per sample should be greater than 2 mL (smaller volumes
may indicate poor sample collection and increase the risk of hemolysis or have
incorrect anticoagulant proportions).
NOTE: • Do not use the control blood for precision check. System program for
the precision check is designed to analyze human blood.
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-3
2.3 HGB/HCT Calibration Samples
Five to ten samples of fresh normal whole blood should be used for the HGB/HCT
calibration. The samples should be analyzed within six hours of collection and kept at room
temperature. Observe the following recommendations when selecting blood for HGB/HCT
calibration purposes.
• Blood of a healthy person who is not taking any medicine
• Blood added with appropriate anticoagulant
• Per-sample whole blood volume to exceed 2 mL
• HGB value to exceed 10.0 g/dL
• HCT value to be within 35.5% - 55.5%
NOTE: • For calibration, do not use EIGHTCHECK-3WP, which was not
prepared for calibration but for the use as control blood.
2.4 Reference Values
2.4.1 Calibrator Calibration
The Assay Target values provided for each calibrator will be the reference values for
Calibrator calibration samples.
2.4.2 HGB/HCT Calibration
Five or more normal blood samples prepared for calibration of HGB and HCT should be
accurately analyzed three times each in accordance with the reference method. The
measurements thus obtained are used as reference values.
HGB values: Cyanmethemoglobin method
HCT values: Microhematocrit method
(Five samples are used for automatic calibration.)
NOTE: • HGB reference value will be influenced by WBC count, diluent, lyse
reagent, HGB light source, temperature, and etc.
• HCT reference value decreases significantly due to excessive
anticoagulant.
CALIBRATION
6-4 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
2.5 Calibration Flow Chart
HGB/HCT calibration start
Completion of HGB/HCT calibration
Calibrator calibration start
Analyze samples by the reference method to determine
reference value (target value).
Automatic calibration: 5 samples
Manual calibration: Over 5 samples
Completion of calibrator calibration
Page 6-3
Automatic
calibration
Manual
calibration
Update calibration
value. Page 6-14
Enter calibration
value. Page 6-13
Select manual
calibration
program. Page 6-12
Calculate calibration
value.
Page 6-11
Analyze in whole
blood mode. Page 6-11
Update calibration
value. Page 6-24
Analyze in
calibrator
analysis mode. Page 6-22
Enter assay target
value.
Page 6-19
Precision check
Page 6-17
Select calibrator
calibration
program. Page 6-15
Select automatic
calibration
program. Page 6-5
Select calibration parameter.
1: HGB
2: HGB and HCT
3: HCT
Page 6-6
Enter target value.
Analyze in whole
blood mode.
Page 6-8
Update calibration
value. Page 6-10
Page 6-7
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-5
3 . AUTOMATIC CALIBRATION
In automatic calibration, five or more fresh, normal blood samples are used for automatic
calibration of HGB and HCT values.
3.1 Executing Automatic Calibration Program
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "3: Calibration."
(3) Press [ENTER] key. The Calibration Menu screen appears.
*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
4:Print Rev. History
Figure 6-3-1: Calibration Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "1: Auto Cal."
(5) Press [ENTER] key. The Automatic Calibration Menu screen appears.
*Auto Cal.*
1:HGB
2:HGB/HCT
3:HCT
Figure 6-3-2: Automatic Calibration Menu Screen
On the Automatic Calibration Menu screen, an automatic calibration parameter can be selected
from among "1: HGB," "2: HGB/HCT," and "3: HCT."
NOTE: • Each menu can be selected directly by entering a numeral from the
numeric keys.
CALIBRATION
6-6 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
3.2 Automatic Calibration Procedure
1 . Selecting Automatic Calibration Parameter
(1) Using [ ] or [ ] key, move the cursor to select an automatic calibration parameter on
the Automatic Calibration Menu Screen:
[1: HGB]: Calibrates HGB alone.
[2: HGB/HCT]: Calibrates two parameters of HGB and HCT at the same time.
[3: HCT]: Calibrates HCT alone.
NOTE: • Each menu can be selected directly by entering a numeral from the
numeric keys.
(2) Press [ENTER] key.
The Automatic Calibration screen for the selected parameter appears.
Target
HGB
1
2
3
4
5
Data
HGB
Compensation
HGB
Current Cal.(%)100.0
New Cal.(%)
*Auto Cal.*
Press [SELECT] to Set.
Figure 6-3-3: HGB Automatic Calibration Screen
Target
HGB HCT HCT HCT
1
2
3
4
5
Data
HGB
Compensation
HGB
Current Cal.(%)100.0 100.0
New Cal.(%)
*Auto Cal.*
Press [SELECT] to Set.
Figure 6-3-4: HGB/HCT Automatic Calibration Screen
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-7
Target
HCT
Current Cal.(%)100.0
New Cal.(%)
1
2
3
4
5
Data
HCT
Compensation
HCT
*Auto Cal.*
Press [SELECT] to Set.
Figure 6-3-5: HCT Automatic Calibration Screen
2 . Entering Target Values
(1) Using the numeric keys, enter the HGB or HCT reference values obtained by the
reference method in the target column.
NOTE: • Press [C] key to delete one letter at a time.
(2) Press [ENTER] key to fix the entered value and move the reverse display to the next
target column.
Target
HGB
12.5
HCT HCT HCT
Current Cal.(%)100.0 100.0
New Cal.(%)
1
2
3
4
5
Data
HGB
Compensation
HGB
*Auto Cal.*
Press [SELECT] to Set.
Figure 6-3-6: Entering Target Values
NOTE: • After entering the 5th target value, pressing [ENTER] key does not
move the reverse display to the next target column.
• An entered value can be set also by pressing [ ] or [ ] key after
entering the target value.
CALIBRATION
6-8 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
(3) When all target values have been entered, press [SELECT] key.
The Target Value Setting Confirmation message appears.
OK to set? Cont. Set Cancel
Figure 6-3-7: Target Value Setting Confirmation Message
(4) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the status for entering target values. And the setting operation
can be continued.
[Set]: Sets target values and charges to the Sample Analysis Waiting status.
[Cancel]: Cancels automatic calibration and returns to the Analysis screen.
(5) Press [ENTER] key to execute the selected process.
3 . Analysis for Automatic Calibration
(1) When the target values are set, the system turns to the Ready status for automatic
calibration analysis.
NOTE: • Automatic calibration analysis is performed in the whole blood mode.
When the analysis mode is set in the pre-diluted mode, the mode
changeover sequence is activated to switch to the whole blood mode.
Target
HGB
12.5
13.0
13.5
11.0
15.0
HCT
50.0
45.2
51.5
40.8
52.5
HCT
*Auto Cal.* WB
Ready
HCT HCT
1
2
3
4
5
Data
HGB
Compensation
HGB
Current Cal.(%)100.0 100.0
New Cal.(%)
Figure 6-3-8: Automatic Calibration Screen (Before Analysis)
(2) Analyze the samples used for determining the standard value.
The sample being analyzed is indicated by the underline cursor.
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-9
(3) After completion of analysis, analysis result appears in the data column and
compensation rate in the compensation column, then the underline cursor moves to the
next sample. Upon completion of more than one sample, average compensation rate is
automatically calculated and displayed at the bottom of the compensation column.
Target
HGB
12.5
13.0
13.5
11.0
15.0
HCT
50.0
45.2
51.5
40.8
52.5
HCT
48.0
43.9
50.0
95.6 103.4
HCT
104.2
103.0
103.0
1
2
3
4
5
Data
HGB
13.0
13.7
14.1
Compensation
HGB
96.2
94.9
95.7
WB*Auto Cal.*
Ready
Current Cal.(%)100.0 100.0
New Cal.(%)
Figure 6-3-9: Automatic Calibration Screen (After Analysis)
CAUTION: • When an error occurs during automatic calibration analysis, the error
message appears in the system status display area. The result of
analysis in which an error has occurred is masked with "---.-," which is
not calculated for compensation rate and not used for average
compensation rate calculation, either.
• If "0" is input to the target value, compensation rate for the sample is
not calculated and the analysis result is not used for average
compensation rate calculation, either.
CALIBRATION
6-10 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
4 . Updating Calibration Value
(1) When all analyses are finished, press [SELECT] key.
New compensation values will be calculated and the Calibration Value Change
Confirmation message will appear.
Change? Yes No
Figure 6-3-10: Calibration Value Change Confirmation Message
NOTE: • The new compensation value is calculated as follows:
New compensation
value (%)
Current compensation value (%) × Average compensation rate (%)
100
=
• When the compensation rate exceeds the following range, "Calibration
Error" is displayed and the Calibration Value Change Confirmation
message does not appear.
Average compensation rate > 105%
Average compensation rate < 95%
New compensation value > 120%
New compensation value < 80%
*Auto Cal.* Calibration Error
Figure 6-3-11: Calibration Error Message
About calibration errors, refer to Chapter 7: TROUBLESHOOTING.
(2) Using [ ] or [ ], move the cursor to select "YES" or "NO."
[YES] : Updates the calibration value and returns to the Analysis screen.
[NO] : Does not update the calibration value and returns to the Analysis screen.
(3) Press [ENTER] key to execute the selected process.
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-11
4 . MANUAL CALIBRATION
In manual calibration, calculated calibration value can be entered using the numeric keys.
4.1 Calculating Calibration Value
(1) Analyze more than five samples, each three times, by the reference method and average
HGB, HCT, WBC, RBC and PLT values.
(2) Gently mix the same samples sufficiently and analyze them in the whole blood mode.
(3) When there is a difference between data gained by analysis with this instrument and the
reference value gained by the reference method, use the following formula to calculate
the new calibration value:
= ×
[Example]
Average of HGB values gained by the reference method = 15.6 g/dL
Average of HGB values gained by this instrument = 15.5 g/dL
Previous calibration value of HGB = 100.0%
100.0 × = 100.65 = 100.7%15.6
15.5
.
.
Therefore, the new calibration value of HGB needs to be set at 100.7%. This means
that the calibration value increased 0.7%.
New calibration
value
Previous
calibration value
Average of values gained
by reference method
Average of values gained
by this instrument
CALIBRATION
6-12 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
4.2 Manual Calibration Procedure
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "3: Calibration."
(3) Press [ENTER] key. The Calibration Menu screen appears.
*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
4:Print Rev. History
Figure 6-4-1: Calibration Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "2: Manual Cal."
(5) Press [ENTER] key. The Manual Calibration screen appears.
HGB
HCT
WBC
RBC
PLT
100.0
100.0
100.0
100.0
100.0
*Manual Cal.*
Press [SELECT] to Set.
Figure 6-4-2: Manual Calibration Screen
NOTE: • Each menu can be selected directly by entering a numeral from the
numeric keys.
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-13
1 . Entering Calibration Value
(1) Using [ ] or [ ] key, move the cursor to select "HGB" or "HCT."
(2) Using the numeric keys, enter the calibration value obtained by calculation.
NOTE: • Press [C] key to delete one letter at a time.
(3) Press [ENTER] key to set the entered value and move the reverse display to the next
parameter.
HGB
HCT
WBC
RBC
PLT
100.7
100.0
100.0
100.0
100.0
*Manual Cal.*
Press [SELECT] to Set.
Figure 6-4-3: Entering Calibration Value
NOTE: • An entered value can be set also by pressing [ ] or [ ] key after
entering the calibration value.
• If no input is made or a space is input, it cannot be set.
CALIBRATION
6-14 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
2 . Updating Calibration Value
(1) When all calibration values are entered, press [SELECT] key.
The Calibration Value Change Confirmation message appears.
Change? Yes No
Figure 6-4-4: Calibration Value Change Confirmation Message
NOTE: • When there is no calibration value changed, the Calibration Value Change
Confirmation message is not displayed and the system returns to the
Analysis screen.
• When the compensation rate exceeds the following range, "Calibration
Error" is displayed and the Calibration Value Change Confirmation
message does not appear.
Compensation rate =
Average of values gained by reference method
Average of values gained by this instrument
X 100
Compensation rate > 105%
Compensation rate < 95%
New compensation value > 120%
New compensation value < 80%
*Manual Cal.* Calibration Error
Figure 6-4-5: Calibration Error Message
About calibration errors, refer to Chapter 7: TROUBLESHOOTING.
(2) Using [ ] or [ ], move the cursor to select "YES" or "NO."
[YES]: Updates the calibration value and returns to the Analysis screen.
[NO]: Does not update the calibration value and returns to the Analysis screen.
(3) Press [ENTER] key to execute the selected process.
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-15
5 . CALIBRATOR CALIBRATION
Calibrate the WBC, RBC, HGB, HCT and PLT using the SCS-1000 calibrator.
5.1 Executing Calibrator Calibration Program
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "3: CALIBRATION."
(3) Press [ENTER] key. The Calibration Menu screen appears.
*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
4:Print Rev. History
Figure 6-5-1: Calibration Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "3: Calibrator."
(5) Press [ENTER] key. The Precision Check screen appears.
The Precision Check screen consists of 2 pages. Use the [ ] and [ ] keys to switch
pages.
Precision Check Screen 1: Displays analysis data.
Precision Check Screen 2: Displays statistical values.
The upper limits of the acceptable precision (reproducibility)
values are displayed in the LMT(%) column for each
parameter.
NOTE: • Each menu can be selected directly by entering a numeral from the
numeric keys.
CALIBRATION
6-16 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
WBC RBC HGB HCT PLT
*Preci.Check* WB
Ready
1
2
3
4
5
6
7
8
9
10
Figure 6-5-2: Precision Check Screen 1
WBC RBC HGB HCT PLT
*Preci.Check* WB
Ready
Mean
SD
CV(%)
LMT(%) 3.5 2.0 1.5 2.0 6.0
Figure 6-5-3: Precision Check Screen 2
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-17
5.2 Calibrator Calibration Procedure
1 . Precision Check
(1) Analyze the sample in the whole blood mode.
The sample being analyzed is indicated by the underline cursor.
After the analysis is completed, the results will be displayed and the underline cursor
will move to the next line.
NOTE: • Precision check analysis is performed in the whole blood mode. When
the analysis mode is set in the pre-diluted mode, the mode changeover
sequence is activated to switch to the whole blood mode.
WBC RBC HGB HCT PLT
*Preci.Check* WB
Analyzing
1 7.0 4.79 15.5 41.2 220
2
3
4
5
6
7
8
9
10
Figure 6-5-4: Precision Check Screen 1 (Analyzing)
(2) When at least three analyses are complete, the average, the standard deviation (SD) and
coefficient of variation (CV%) will be automatically calculated and displayed in the
"Mean", "SD" and "CV(%)" columns, respectively.
NOTE: • The first analysis data is not included in the calculation.
The first analysis data is overwritten by the second analysis data.
• When an error occurs during precision check analysis, the error
message appears in the system status display area. The analysis
result with an error is masked with "---.-." At this time, the underline
cursor will not move to the next line and the next sample is analyzed
using the same number.
CALIBRATION
6-18 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
(3) Analyze the sample a total of 11 times.
If the obtained CV(%) values for all five parameters are within the Precision Limit
(CV%) values, the menu will be displayed in the menu display area.
WBC RBC HGB HCT PLT
*Preci.Check* WB
Mean 6.9 4.82 14.0 40.9 212
SD 0.048 0.043 0.056 0.532 1.69
CV(%) 0.7 0.9 0.4 1.3 0.8
LMT(%) 3.5 2.0 1.5 2.0 6.0
1:Calibration 3:Cancel
Figure 6-5-5: Precision Check Passed Screen
(4) Using the numeric keys, select "1: Calibrate" or "3: Cancel."
[1: Calibrate]: The SCS-1000 Analyzing Calibrator screen appears.
[3: Cancel]: Returns to the Analysis screen.
If any of the obtained CV(%) values exceed the LMT (%) value, the CV (%) value will
be reverse display and the "1: Calibrate" menu will not be displayed.
Refer to Chapter 7 "Troubleshooting" and take corrective action. If assistance is
required, contact a Sysmex service representative.
WBC RBC HGB HCT PLT
*Preci.Check* WB
Mean 6.90 4.82 15.1 40.9 212
SD 0.255 0.043 0.056 0.532 1.69
CV(%) 3.7 0.9 0.4 1.3 0.8
LMT(%) 3.5 2.0 1.5 2.0 6.0
3:Cancel
Figure 6-5-6: Precision Check Failed Screen
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-19
2 . Entering Target Values
To perform calibrator calibration, you must enter the Assay Target values exactly as provided
with the Sysmex SCS-1000 Calibrator product. Verify that the assay sheet matches the
Lot # of calibrator.
(1) When the precision check is completed and "1: Calibration" is selected, the Analyzing
Calibrator screen appears.
The Analyzing Calibrator screen consists of 2 pages. Use the [ ] and [ ] keys to
switch pages.
Analyzing Calibrator Screen 1: Displays the Target values and analysis data.
Analyzing Calibrator Screen 2: Displays statistical values.
When the Analyzing Calibrator screen 1 is displayed, the area to input the WBC Target
value is reverse display.
*Calibrator*
Target
0
1
2
3
4
5
Press [SELECT] to Set.
WBC RBC HGB HCT PLT
Figure 6-5-7: Analyzing Calibrator Screen 1
WBC RBC HGB HCT PLT
*Calibrator*
Range V.
MaxRange 0.7 0.20 0.5 1.8 35
Mean V.
Delta%
ACPT LMT 3.95 1.54 0.76 2.21 3.53
SERV LMT 14.00 5.00 5.00 5.00 15.00
Current 102.1 99.9 101.6 98.4 100.4
New
Figure 6-5-8: Analyzing Calibrator Screen 2
CALIBRATION
6-20 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
Explanation of Displayed Items
Target : Assay Target values provided with calibrator are entered.
Range V. : The highest value minus the lowest value within five consecutive
analyses is displayed.
MaxRange : The maximum Range Value allowed is automatically calculated from
the Assay Target and displayed.
Mean V. : Mean value of five consecutive analysis results.
Delta% :
Assay Target - Mean Value
Mean Value
x 100 (%) is automatically calculated
and displayed.
ACPT LMT : Maximum Upper Limit of Delta Percent (%). Calibration is not
necessary when the Delta Percent is within this limit.
SERV LMT : If the Delta Percent exceeds this limit, technical assistance may be
necessary and your instrument system needs service. Calibration
will not be allowed.
Current : Current calibration value, which was obtained in the previous
calibration procedure.
New : New calibration value calculated from the calibrator analysis.
(2) Using the numerical keys, enter the assay target value exactly for the WBC parameter.
Press [Enter] key, and the input value is displayed in the "Target" column.
The reverse display then moves to the next parameter.
Enter the assay target values for all 5 parameters.
*Calibrator*
Target 7.0
0
1
2
3
4
5
Press [SELECT] to Set.
WBC RBC HGB HCT PLT
Figure 6-5-9: Entering Target Value
NOTE: • Press [C] key to delete entirely.
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-21
(3) When the assay target values for all five parameters are entered, make sure once again
the entered values are correct with the Assay Sheet. If correction is required, select the
parameter using the [ ] and [ ] keys, and enter the correct value.
*Calibrator*
Target 7.0 4.80 15.0 40.8 220
0
1
2
3
4
5
WBC RBC HGB HCT PLT
Press [SELECT] to Set.
Figure 6-5-10: Verifying Target Value Screen
(4) When all assay target values have been entered, press [SELECT] key.
The Target values setting confirmation message appears.
OK to set? Cont. Set Cancel
Figure 6-5-11: Target Value Setting Confirmation Message
(5) Using [ ] and [ ] key, move the cursor to select "Cont.", "Set" or "Cancel."
[Cont.]: Returns to the status for entering assay target values. And the setting
operation can be continued.
[Set]: Sets assay target values and charges to the calibrator analysis waiting
status.
[Cancel]: Cancels calibrator calibration and returns to the Analysis screen.
(6) Press [ENTER] key to execute the selected process.
CALIBRATION
6-22 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
3 . Analysis for Calibrator Calibration
(1) When the target values are set, the system turns to the Ready status for calibrator
analysis.
NOTE: • Calibrator analysis is performed in the whole blood mode. When the
analysis mode is set in the pre-diluted mode, the mode changeover
sequence is activated to switch to the whole blood mode.
In the whole blood mode, "CL" in the calibrator analysis mode is
displayed in the system status display area.
*Calibrator*
Target 7.0 4.80 15.0 40.8 220
0
1
2
3
4
5
WBC RBC HGB HCT PLT
CL
Ready
Figure 6-5-12: Analyzing Calibrator Screen 1 (1)
*Calibrator*
Target 7.0 4.80 15.0 40.8 220
0 6.9 4.77 15.3 40.8 214
1
2
3
4
5
WBC RBC HGB HCT PLT
CL
Analyzing
Figure 6-5-13: Analyzing Calibrator Screen 1 (2)
(2) When an analysis is complete, the results will be displayed and the underline cursor
will move to the next line.
(3) When the six analysis data are completed, "Range V.", "Mean V.", "Delta%" and
"New" will begin to be automatically calculated and displayed in their respective
columns.
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-23
NOTE: • The first analysis data is not included in the calculation.
• When an error occurs during calibrator analysis, the error message
appears in the system status display area. The analysis result with
an error is masked with "---.-" or "***.*". At this time, the underline
cursor will not move to the next line and the next sample is analyzed
using the same number.
*Calibrator*
Target 7.0 4.80 15.0 40.8 220
0 6.9 4.77 15.3 40.8 214
1 6.9 4.82 15.1 40.2 210
2 7.0 4.79 14.9 41.3 213
3 7.0 4.89 15.1 41.4 212
4 7.0 4.88 15.0 41.5 211
5 7.0 4.78 15.1 41.4 213
WBC RBC HGB HCT PLT
Figure 6-5-14: Analyzing Calibrator Screen 1
WBC RBC HGB HCT PLT
*Calibrator*
Range V. 0.1 0.12 0.4 1.3 4
MaxRange 0.7 0.20 0.5 1.8 35
Mean V. 6.9 4.83 15.0 41.2 212
Delta% 0.03 0.66 0.27 0.87 3.87
ACPT LMT 3.95 1.54 0.76 2.21 3.53
SERV LMT 14.00 5.00 5.00 5.00 15.00
Current 102.1 99.9 101.6 98.4 100.4
New 102.1 99.9 101.6 98.4 104.2
Figure 6-5-15: Analyzing Calibrator Screen 2
CALIBRATION
6-24 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
If the Range values exceed the MaxRange values, the Range value will be reverse
display.
If the Delta% values exceed SERV LMT values, the Delta% value will be reverse
display.
Calibration will not be allowed.
WBC RBC HGB HCT PLT
*Calibrator*
Range V. 0.1 0.12 0.6 1.3 4
MaxRange 0.7 0.20 0.5 1.8 35
Mean V. 6.9 4.83 15.0 41.2 212
Delta% 0.03 4.66 0.27 0.87 3.87
ACPT LMT 3.95 1.54 0.76 2.21 3.53
SERV LMT 14.00 5.00 5.00 5.00 15.00
Current 102.1 99.9 101.6 98.4 100.4
New 102.1 99.9 101.6 98.4 104.2
Figure 6-5-16: Rang V. > MaxRange or Delta% > SERV LMT Screen
1) When there are:
Range V. > MaxRange
or Delta% > SERV LMT
or Delta% ACPT LMT,
New = Current
2) Other than above,
New = (Target/Mean V.) × Current
4 . Updating Calibration Value
(1) After the statistical values are calculated, press [SELECT] key.
New compensation values will be calculated and the Calibration Value Change
Confirmation message will appear.
Change? Yes No
Figure 6-5-17: Calibration Value Change Confirmation Message
(2) Using [ ] or [ ], move the cursor to select "Yes" or "No."
[Yes] : Updates the calibration value and returns to the Analysis screen.
[No] : Does not update the calibration value and returns to the Analysis screen.
(3) Press [ENTER] key to execute the selected process.
CALIBRATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-25
6 . CALIBRATION HISTORY PRINT
Using this menu, a recent five times calibration history can be printed from the built-in
printer.
Execution of Calibration History Print
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "3: Calibration."
(3) Press [ENTER] key. The Calibration Menu screen appears.
*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
4:Print Rev. History
Figure 6-6-1: Calibration Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "4: Print Rev. History."
(5) Press [ENTER] key.
The built-in printer prints the calibration history.
Print Example
....
Date 31/10/1999
Time 10:23
*Cal.History*
Date 29/10/1999
Time 08:23
HGB 95.6
HCT 103.4
Date 30/10/1999
Time 08:23
HGB 99.3
HCT 101.2
Figure 6-6-2: Calibration History Print
Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.
Sysmex KX-21N Operator’s Manual -- October 1999
CHAPTER 7 TROUBLESHOOTING
1. INTRODUCTION................................................................. 7-1
2. WHEN YOU SUSPECT A TROUBLE ........................................7-2
2.1 Alphabetical List of Error Messages
Displayed on Analysis Screen ............................................7-3
2.2 Alphabetical List of Error Messages Displayed on HELP Screen ....7-4
2.3 Functional List of Error Messages .......................................7-5
3. TROUBLESHOOTING GUIDE ................................................7-7
3.1 Pressure/Vacuum Errors...................................................7-7
3.2 Chamber Errors........................................................... 7-10
3.3 Motor Errors .............................................................. 7-13
3.4 Transducer Errors ........................................................ 7-15
3.5 Temperature Errors....................................................... 7-16
3.6 Analysis Errors ........................................................... 7-17
3.7 Memory Errors ........................................................... 7-23
3.8 Others...................................................................... 7-25
3.9 Maintenance Errors....................................................... 7-27
3.10 Printer Errors ............................................................. 7-30
3.11 External Device Errors................................................... 7-33
4. STATUS DISPLAY............................................................. 7-34
5. ERROR HISTORY PRINT .................................................... 7-36
6. PROGRAM VERSION ......................................................... 7-37
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-1
1 . INTRODUCTION
If the running instrument develops any symptom that you suspect to be a trouble, check it
making reference to "2. WHEN YOU SUSPECT A TROUBLE" which begins from the next
page. When there is not any item that confirms to the trouble in question or if "Action" fails
to eliminate the symptom, contact your Sysmex service representative for assistance.
When a trouble occurs, the instrument displays an error message on the LCD screen. When
there occurs an error unique to a sample analyzed, analysis data is displayed with a flag.
This chapter describes the cause of a trouble on which an error message is displayed, along
with actions that the customer can take in checking and repairing.
HELP Function
When a trouble has occurred, the warning alarm sounds and an error message is displayed
on the screen. By pressing [HELP] key on the panel keyboard, you can stop the alarm and
change over to the HELP screen that shows what action to take against the error.
Supplementary explanation for that function is given here.
In the event multiple errors occur at the same time, press [HELP] key. The errors that have
occurred are listed in the order from higher priority.
*Help*
Multiple errors occurred.
Pressure/Vac Error
Rinse Motor Error
Waste Not Draining
Sampling Error
Room Temp. High
Press[HELP] for more information.
Figure 7-1-1: Help Screen (Error List)
Press [HELP] key again. The screen changes to the HELP screen for the error listed at top.
NOTE: • When you contact your Sysmex service representative, inform him of
"ERR CODE" given on the HELP screen. By doing so, you can inform
him of the instrument's status easier and more correctly.
• When you repair in accordance with TROUBLESHOOTING, be sure
to turn the power OFF except when you have to confirm displays and
instructions on the screen.
If you repair with the power turned ON, you have a risk of electric
shock hazard and you may give a permanent damage to electric parts.
WARNING
TROUBLESHOOTING
7-2 Sysmex KX-21N Operator’s Manual -- October 1999
2 . WHEN YOU SUSPECT A TROUBLE
1. Turning the power ON does not start the
unit.
• Is the power cord connected securely?
• Isn't the fuse blown?
Refer to Chapter 4, Section 8.2: Replace Fuse.
• Is the power supplied to AC outlet?
2. When the power is ON, nothing is
displayed and "beep" keeps sounding.
• There is a possibility that memory error has occurred.
Turn OFF the power, and turn it ON again 1 - 2
minutes later.
3. The screen displays nothing. • Isn't LCD brightness properly adjusted?
Refer to Chapter 1, Section 8.3: LCD Brightness
Adjustment.
4. The screen displays "PU Sleeping"
message and no key entry is accepted.
• Timer mode turned OFF the pneumatic unit power.
To return the instrument to the ready status, press
the [SELECT] key to return to the analysis result
screen, and then the [Start] switch.
5. Fluid leaks from the unit. • Turn OFF the power and wipe off leaking fluid. If fluid
leakage persists after turning ON the power, contact
your Sysmex service representative.
6. Data has error. • Check QC data of control blood.
• Referring to Chapter 4: INSTRUMENT
MAINTENANCE AND SUPPLIES
REPLACEMENT, conduct the maintenance
below:
Chapter 4, Section 5.2: Clean Transducer
Chapter 4, Section 6.1: Clean SRV
7. An error occurs. Search the following message lists for an error in
question and refer to the corresponding pages in
TROUBLESHOOTING:
1) Message List
To search the pages, the error messages are
listed in "Alphabetical" and "Functional" orders.
2) TROUBLESHOOTING
Cause and action for each trouble are
described for respective error message.
• When operating, always wear rubber gloves. After completion of work,
wash hands with disinfectant. If your hands are contaminated by
blood, etc., infection of bacteria can result.
WARNING
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-3
2.1 Alphabetical List of Error Messages Displayed on Analysis
Screen
[A]
Abnormal DP (when data printer is incorporated)---------------------------------------------- 7-31
Abnormal GP (when graphic printer is incorporated)-----------------------------------7-31, 7-32
Abnormal IP ---------------------------------------------------------------------------------7-30, 7-32
Analysis Error -------------------------------------------------------------------------------7-21, 7-22
[B]
Background Error ----------------------------------------------------------------------------------7-17
[C]
Calibration Error------------------------------------------------------------------------------------7-26
Clean SRV. -----------------------------------------------------------------------------------------7-27
Clean Transducer-----------------------------------------------------------------------------------7-29
Clean Waste Chamber. ----------------------------------------------------------------------------7-28
[H]
HGB Error ------------------------------------------------------------------------------------------7-20
Host Comm. Error ---------------------------------------------------------------------------------7-33
[M]
Momentary Power Failure-------------------------------------------------------------------------7-24
Memory Error---------------------------------------------------------------------------------------7-23
[P]
Pressure/Vac Error ----------------------------------------------------------------------- 7-7, 7-8, 7-9
[Q]
QC Error---------------------------------------------------------------------------------------------7-25
[R]
RBC Aperture Clog --------------------------------------------------------------------------------7-15
Replenish Diluent-----------------------------------------------------------------------------------7-11
Replenish Lyse -------------------------------------------------------------------------------------7-12
Rinse Motor Error---------------------------------------------------------------------------7-13, 7-14
Room Temp. High ---------------------------------------------------------------------------------7-16
Room Temp. Low----------------------------------------------------------------------------------7-16
[S]
Sampling Error ------------------------------------------------------------------------------7-18, 7-19
Set Value Error ------------------------------------------------------------------------------7-23, 7-24
[W]
Waste Not Draining --------------------------------------------------------------------------------7-10
WBC Aperture Clog -------------------------------------------------------------------------------7-15
Sysmex KX-21N Operator’s Manual -- Revised February 2000
TROUBLESHOOTING
7-4 Sysmex KX-21N Operator’s Manual -- October 1999
2.2 Alphabetical List of Error Messages Displayed on HELP
Screen
0.05 MPa Pressure Error----------------------------------------------------------------------------7-7
0.05 MPa Pressure Error at count------------------------------------------------------------------7-9
0.0333 MPa Vacuum Error -------------------------------------------------------------------------7-8
[A]
Abnormal detection sensitivity-------------------------------------------------------------------- 7-22
[B]
Background count exceeds tolerance.------------------------------------------------------------ 7-17
[C]
Calibration value is out of range. ----------------------------------------------------------------7-26
Clean the SRV. -------------------------------------------------------------------------------------7-27
Clean the Transducer. ----------------------------------------------------------------------------7-29
Clean the Waste Chamber. ----------------------------------------------------------------------- 7-28
Clog in the aperture (RBC)------------------------------------------------------------------------7-15
Clog in the aperture (WBC)----------------------------------------------------------------------- 7-15
[D]
DP printout error (when data printer is incorporated)------------------------------------------ 7-31
[E]
Error has occurred during counting (PLT). ---------------------------------------------------- 7-18
Error has occurred during counting (RBC). ---------------------------------------------------- 7-18
Error has occurred during counting (WBC).---------------------------------------------------- 7-18
Error occurred during HGB analysis. ----------------------------------------------------------- 7-20
Error on IP ------------------------------------------------------------------------------------------7-30
Error on Rinse Cup -------------------------------------------------------------------------7-13, 7-14
[G]
GP paper empty (when graphic printer is incorporated)--------------------------------------- 7-32
GP printout error (when graphic printer is incorporated)-------------------------------------- 7-31
[H]
Host Output Error ----------------------------------------------------------------------------------7-33
[I]
IP paper empty--------------------------------------------------------------------------------------7-32
[M]
Memory error occurred. (Repairing) ------------------------------------------------------------ 7-23
Memory error occurred. (Turn OFF then ON the power.) ----------------------------7-23, 7-24
Momentary power failure occurred.-------------------------------------------------------------- 7-24
[Q]
QC data falls out of control limits. --------------------------------------------------------------- 7-25
[R]
Replenish Diluent Container. --------------------------------------------------------------------- 7-11
Replenish Lyse Container. ----------------------------------------------------------------------- 7-12
Room Temp. Error --------------------------------------------------------------------------------7-16
[S]
Sampling Error has occurred. -------------------------------------------------------------------- 7-19
[W]
Waste Not Drained ---------------------------------------------------------------------------------7-10
WBC/HGB Analysis Error------------------------------------------------------------------------7-21
Sysmex KX-21N Operator’s Manual -- Revised February 2000
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-5
2.3 Functional List of Error Messages
NOTE: • [ ] indicates error naming that is displayed on the Analysis screen.
1 . Pressure/Vacuum Errors
0.05 MPa Pressure Error [Pressure/Vac Error]-------------------------------------------7-7
0.0333 MPa Vacuum Error [Pressure/Vac Error] ----------------------------------------7-8
0.05 MPa Pressure Error at count [Pressure/Vac Error] ---------------------------------7-9
2 . Chamber Errors
Waste Not Drained [Waste Not Draining]----------------------------------------------- 7-10
Replenish Diluent Container. [Replenish Diluent]-------------------------------------- 7-11
Replenish Lyse Container. [Replenish Lyse] ------------------------------------------- 7-12
3 . Motor Errors
Error on Rinse Cup [Rinse Motor Error]-----------------------------------------7-13, 7-14
4 . Aperture Errors
Clog in the aperture (WBC) [WBC Aperture Clog]------------------------------------ 7-15
Clog in the aperture (RBC) [RBC Aperture Clog] ------------------------------------- 7-15
5 . Temperature Errors
Room Temp. Error [Room Temp. High]------------------------------------------------ 7-16
Room Temp. Error [Room Temp. Low] ------------------------------------------------ 7-16
6 . Analysis Errors
Background count exceeds tolerance. [Background Error] --------------------------- 7-17
Error has occurred during counting. (PLT) [Sampling Error] ------------------------ 7-18
Error has occurred during counting. (RBC) [Sampling Error] ----------------------- 7-18
Error has occurred during counting. (WBC) [Sampling Error]----------------------- 7-18
Sampling Error has occurred. [Sampling Error]---------------------------------------- 7-19
Error occurred during HGB analysis. [HGB Error] ----------------------------------- 7-20
WBC/HGB Analysis Error [Analysis Error]-------------------------------------------- 7-21
Abnormal detection sensitivity [Analysis Error]---------------------------------------- 7-22
7 . Memory Errors
Memory error occurred. (Turn OFF then ON the power.) [Memory Error]-------- 7-23
Memory error occurred. (Repairing) [Set Value Error]-------------------------------- 7-23
Memory error occurred. (Turn OFF then ON the power.) [Set Value Error] ------ 7-24
Momentary power failure occurred. [-]-------------------------------------------------- 7-24
8 . Others
QC data falls out of control limits. [QC Error]------------------------------------------ 7-25
Calibration value is out of range. [Calibration Error] ---------------------------------- 7-26
Sysmex KX-21N Operator’s Manual -- Revised February 2000
TROUBLESHOOTING
7-6 Sysmex KX-21N Operator’s Manual -- October 1999
9 . Maintenance Errors
Clean the SRV. [Clean SRV.] ------------------------------------------------------------ 7-27
Clean the Waste Chamber. [Clean Waste Chamber.] ---------------------------------- 7-28
Clean the Transducer. [Clean Transducer.] --------------------------------------------- 7-29
1 0 . Printer Errors
Error on IP [Abnormal IP]-----------------------------------------------------------------7-30
GP printout error [Abnormal GP]--------------------------------------------------------- 7-31
DP printout error [Abnormal DP] --------------------------------------------------------- 7-31
IP paper empty [Abnormal IP] ------------------------------------------------------------ 7-32
GP paper empty [Abnormal GP]---------------------------------------------------------- 7-32
1 1 . External Option Errors
Host Output Error [Host Comm. Error]------------------------------------------------- 7-33
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-7
3 . TROUBLESHOOTING GUIDE
3.1 Pressure/Vacuum Errors
Error Message Meaning of Message
"Pressure/Vac Error"
0.034 [0.039 - 0.059]
ERR CODE:XXXXX.X.X
*Help*
0.05 MPa Pressure Error
Adjust 0.05 MPa Pressure.
Restarting to monitor the pressure
1:End of Adj
[1]
0.05 MPa is out of the monitor range in Ready
status.
Monitor range: 0.039 - 0.059 MPa
Cause 1) 0.05 MPa pressure adjustment error
2) Pneumatic unit pressure error
3) Air leakage from pressure line
Action 1) Adjust Pressure to 0.05 MPa.
The HELP screen displays pressure value in real time.
Adjust pressure referring to Chapter 8, Section 2.3: Adjusting
Pressure to 0.05 MPa.
2) Check Pressure Line
Check the pressure line for loosened nipple or tube, or breakage.
If any abnormality is noted, reconnect or replace.
After adjustment or check, press [1] key to return to the original
screen.
Analysis after error
occurrence
Not Ready until the error is resolved.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
TROUBLESHOOTING
7-8 Sysmex KX-21N Operator’s Manual -- October 1999
Error Message Meaning of Message
"Pressure/Vac Error"
ERR CODE:XXXXX.X.X
*Help*
0.0333 MPa Vacuum Error
Adjust 0.0333 MPa Vacuum.
Restarting to monitor the vacuum[1]
1:End of Adj
0.0287 [0.0307 - 0.0360]
0.0333 MPa vacuum is out of the monitor range
in Ready status.
Monitor range: 0.0307 - 0.0360 MPa
Cause 1) 0.0333 MPa vacuum adjustment error
2) Fluid back-flows into the trap chamber.
3) Pneumatic unit vacuum error
4) Air leakage from vacuum line
Action 1) Adjust Vacuum to 0.0333 MPa
The HELP screen displays vacuum value in real time.
Adjust vacuum referring to Chapter 8, Section 2.4: Adjusting
Vacuum to 0.0333 MPa.
2) Discard fluid in Trap Chamber
Discard fluid if collected. Refer to Chapter 4, Section 3.2: Check
Trap Chamber Level and Discard.
3) Check Vacuum Line
Check the vacuum line for loosened nipple or tube, or breakage. If
any abnormality is noted, reconnect or replace.
After adjustment or check, press [1] key to return to the original
screen.
Analysis after error
occurrence
Not Ready until the error is resolved.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-9
Error Message Meaning of Message
"Pressure/Vac Error"
ERR CODE:XXXXX.X.X
*Help*
0.05 MPa Pressure Error at count
Turn OFF then ON the power.
3:Ana.Screen
0.05 MPa pressure is out of the monitor range
during analysis.
Monitor range: 0.029 - 0.069 MPa
Cause 1) 0.05 MPa pressure adjustment error
2) Pneumatic unit pressure error
3) Air leakage from pressure line
Action 1) Adjust Pressure to 0.05 MPa
Turn the power OFF, and turned it ON again. Then adjust pressure
referring to Chapter 8, Section 2.3: Adjust 0.05 MPa Pressure.
2) Check Pressure Line
Check the pressure line for loosened nipple or tubing, or
breakage. If any abnormality is noted, reconnect or replace.
After adjustment or check, press [1] key to return to the original
screen.
Analysis after error
occurrence
The power needs to be turned OFF then ON again.
NOTE: • Press [3] key to return to the Analysis screen. The status is not
ready for analysis, but the processing, etc. of stored data in Select
Menu can be performed.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
TROUBLESHOOTING
7-10 Sysmex KX-21N Operator’s Manual -- October 1999
3.2 Chamber Errors
Error Message Meaning of Message
"Waste Not Draining"
ERR CODE:XXXXX.X.X
Waste Not Drained
Check kinked or blocked tubings.
Retrying to drain the waste
*Help*
3:Cancel1:Draining
[1]
Waste in the waste chamber can not be drained
within the prescribed draining time.
Cause 1) Breakage or clogging of waste chamber or waste line tube
2) Pneumatic unit pressure error
3) Air leakage from pressure line
4) Float switch malfunction
5) Faulty operation of solenoid or master valve
Action 1) Check Waste Line Tube
Check the waste drain line for breakage, clogging, etc. If any
abnormality is present, clean or replace the tube. Specially check
for contaminant or clogging near the drain outlet nipple.
2) Check Pressure Line
Check the pressure line for loosened nipple or tubing, or
breakage. If any abnormality is noted, reconnect or replace.
After adjustment or check, press [1] key to return to the original
screen.
Analysis after error
occurrence
Not Ready until the error is resolved.
NOTE: • Press [3] key to return to the Analysis screen. The status is not
ready for analysis, but the processing, etc. of stored data in Select
Menu can be performed.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-11
Error Message Meaning of Message
"Replenish Diluent"
ERR CODE:XXXXX.X.X
*Help*
1:Asp. Reag. 3:Cancel
Replenish Diluent Container.
Reaspirating Diluent[1]
Diluent (CELLPACK) can not be aspirated
within the prescribed diluent aspiration time.
Cause 1) Lack of diluent (CELLPACK)
2) Diluent aspiration line error
3) Air leakage from vacuum line
4) Float switch malfunction
5) Faulty operation of solenoid valve or master valve
Action 1) Replenish Diluent (CELLPACK)
If there is no diluent, replenish with a new diluent container.
2) Check Tube
Check the diluent line tubing for breakage and the nipple for
looseness. If any abnormality is noted, reconnect or replace.
After replenishment or check, press [1] to return to the original
screen.
3) Check Vacuum Line
Check the vacuum line for breakage and loosened nipple or
tubing.
Analysis after error
occurrence
Not Ready until the error is resolved.
NOTE: • Press [3] key to return to the Analysis screen. The status is not
ready for analysis, but the processing, etc. of stored data in Select
Menu can be performed.
TROUBLESHOOTING
7-12 Sysmex KX-21N Operator’s Manual -- October 1999
Error Message Meaning of Message
"Replenish Lyse"
ERR CODE:XXXXX.X.X
*Help*
1:Asp. Reag. 3:Cancel
Replenish Lyse Container.
Reaspirating Lyse[1]
No lyse remains.
Cause 1) Lack of lyse (STROMATOLYSER-WH)
2) Float switch malfunction
Action 1) Replenish Lyse (STROMATOLYSER-WH)
When no lyse is left, replenish with a new lyse container.
After replenishment or check, press [1] key to return to the original
screen.
Analysis after error
occurrence
Not Ready until the error is resolved.
NOTE: • Press [3] key to return to the Analysis screen. The status is not
ready for analysis, but the processing, etc. of stored data in Select
Menu can be performed.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-13
3.3 Motor Errors
Error Message Meaning of Message
"Rinse Motor Error"
ERR CODE:XXXXX.X.X
*Help*
Error on Rinse Cup
Turn OFF then ON the power.
If Rinse Cup is out of position,
Turn power OFF and correct manually.
3:Ana.Screen
The rinse cup is at lower position at start-up
(This happens only when the power is ON.)
Cause 1) Rinse cup drive motor malfunction
2) The power was turned ON with the rinse cup remaining lowered.
Action 1) Turn OFF the power, manually raise the rinse cup with both hands
to the original top position, then turn ON the power.
Analysis after error
occurrence
The power needs to be turned OFF then ON again.
NOTE: • Press [3] key to return to the Analysis screen. The status is not
ready for analysis, but the processing, etc. of stored data in Select
Menu can be performed.
TROUBLESHOOTING
7-14 Sysmex KX-21N Operator’s Manual -- October 1999
Error Message Meaning of Message
"Rinse Motor Error"
ERR CODE:XXXXX.X.X
*Help*
Error on Rinse Cup
Turn OFF then ON the power.
3:Ana.Screen
The rinse cup is not operating normally.
Cause 1) Rinse cup drive motor malfunction
2) Error of the rinse cup drive motor controller
Faulty operation of CPU due to sudden noise interference, etc.
Action 1) Turn OFF the power and check to see that tubing, etc. are not in
contact with the top or bottom of rinse cup.
2) Turn OFF the power and clean the rinse cup.
Refer to Chapter 4, Section 7.2: Clean Rinse Cup.
Analysis after error
occurrence
The power needs to be turned OFF then ON again.
NOTE: • Press [3] key to return to the Analysis screen. The status is not
ready for analysis, but the processing, etc. of stored data in Select
Menu can be performed.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-15
3.4 Transducer Errors
Error Message Meaning of Message
"WBC Aperture Clog"
"RBC Aperture Clog"
Clog in the aperture
Parameter: WBC RBC
1 Execute clog removal sequence.
If clog persists,
press[SELECT],then
[Maintenance]->[Clean Transducer]
or dab with brush after [SELECT],
[Maintenance]->[Drain TD Chamber]
ERR CODE:XXXXX.X.X
1:Clog Remove
*Help*
3:Cancel
The monitor value for aperture clog is out of the
prescribed range.
Cause 1) Transducer aperture clogging
Action 1) Remove Aperture Clogging.
Press [1] key to execute automatic clog removal sequence.
2) Transducer Rinse Sequence
Pour 1 mL each of CELLCLEAN in the transducer chamber to
perform auto rinse sequence.
Refer to Chapter 4, Section 5.2: Clean Transducer.
3) Clean the Transducer with Brush
Clean the aperture with brush.
Refer to Chapter 4, Section 7.3: Clean WBC/RBC Transducer
Aperture.
Analysis after error
occurrence
Ready for analysis (although the next sample could be affected)
NOTE: • Press [3] key to return to the Analysis screen. Although the system
is ready for analysis, the error may occur in the next analysis.
TROUBLESHOOTING
7-16 Sysmex KX-21N Operator’s Manual -- October 1999
3.5 Temperature Errors
Error Message Meaning of Message
"Room Temp. High"
"Room Temp. Low"
ERR CODE:XXXXX.X.X
*Help*
Room Temp.Error
Analysis data has lower reliability.
Check the room temperature.
41.5˚C [10.0 - 40.0]
3:Return
Temperature in the unit (around the transducer)
is out of the monitor range.
Monitor range: 10.0 - 40.0°C
Cause 1) Temperature in the transducer is high (or low.)
Action 1) Check the Ambient Temperature
Check to see that the ambient temperature is between 15°C -
30°C.
Analysis after error
occurrence
Ready for analysis (although the next sample could be affected)
NOTE: • Press [3] key to return to the Analysis screen. Although the system
is ready for analysis, the error may occur in the next analysis.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-17
3.6 Analysis Errors
Error Message Meaning of Message
"Background Error"
Background count exceeds tolerance.
WBC 0.1 [<=0.3] (×103/µL)
RBC 0.05 [<=0.02](×106/µL)
HGB 0.0 [<=0.1] (g/dL)
PLT 12 [<=10] (×103/µL)
ERR CODE:XXXXX.X.X
*Help*
3:Cancel1:Auto Rinse
Suspected a dirty aperture or SRV.
Execute an Auto Rinse.[1]
In Auto Rinse, background check reveals that
the background count of any parameter
exceeds the tolerance.
Tolerance: WBC 0.3×103
/µL or less
RBC 0.02×106
/µL or less
HGB 0.1g/dL or less
PLT 10×103
/µL or less
Cause 1) Dirty aperture
2) Dirty HGB flow cell
3) Bubbles mixing
4) Faulty reagent
Action 1) Auto Rinse
Press [1] key to perform Auto Rinse.
2) Clean Transducer
Refer to Chapter 4, Section 5.2: Clean Transducer or Chapter 4,
Section 7.3: Clean WBC/RBC Transducer Aperture.
3) Clean SRV
Refer to Chapter 4, Section 6.1: Clean Sampling Valve (SRV).
4) Replenish Reagent
Faulty lyse will affect background for WBC or HGB. In case diluent
is faulty, it will affect all parameters, notably PLT background count.
Analysis after error
occurrence
Ready for analysis (although the next sample could be affected)
NOTE: • Press [3] key to return to the Analysis screen. Although the system
is ready for analysis, the error may occur in the next analysis.
TROUBLESHOOTING
7-18 Sysmex KX-21N Operator’s Manual -- October 1999
Error Message Meaning of Message
"Sampling Error"
ERR CODE:XXXXX.X.X
Execute clog removal sequence.
If clog persists,
press[SELECT], then
[Maintenance]->[Clean Transducer]
or dab with brush after [SELECT]
[Maintenance]->[Drain T.D.Chamber]
[1]
1:Clog Remove
*Help*
Error has occurred during counting.
Parameter: WBC PLT
Suspected a clogged aperture.
3:Cancel
Sampling data falls into disorder.
Sampling data refers to the count taken every
0.5 seconds during counting. The system
monitors the counts.
Cause 1) Dirty aperture
2) Effect of external noise interference
Action 1) Clean Transducer
1. Remove Aperture Clogging
Press [1] key to execute automatic clog removal sequence.
2. Transducer Rinse Sequence
Pour 1 mL each of CELLCLEAN in the transducer chamber to
perform auto rinse sequence. Refer to Chapter 4, Section 5.2:
Clean Transducer.
3. Clean the Transducer with Brush
Clean the aperture using brush. Refer to Chapter 4, Section
7.3: Clean WBC/RBC Transducer Aperture.
2) Remove Source of External Noise
Move the noise source away from the unit.
Analysis after error
occurrence
Ready for analysis (although the next sample could be affected)
NOTE: • Press [3] key to return to the Analysis screen. Although the system
is ready for analysis, the error may occur in the next analysis.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-19
Error Message Meaning of Message
"Sampling Error"
ERR CODE:XXXXX.X.X
*Help*
Sampling Error has occurred.
3:Retuen
Sampling data falls into disorder.
Sampling data refers to the count taken every
0.5 seconds during counting. The system
monitors the counts taken.
Cause 1) CPU malfunction due to sudden noise interference, etc.
Action 1) Turn OFF then ON the power again.
If the error persists after turning ON the power again, contact your
Sysmex service representative.
Analysis after error
occurrence
Ready for analysis (although the next sample could be affected)
NOTE: • Press [3] key to return to the Analysis screen. Although the system
is ready for analysis, the error may occur in the next analysis.
TROUBLESHOOTING
7-20 Sysmex KX-21N Operator’s Manual -- October 1999
Error Message Meaning of Message
"HGB Error"
*Help*
3:Cancel
Clean TD Chamber will be performed.
(It will take approx. 7 minutes.)
[1]
Error occurred during HGB analysis.
Flow Cell may be dirty.
ERR CODE:XXXXX.X.X
1:Exec. Clean
HGB converted value is out of the prescribed
range.
1. Blank value is out of the range.
2. Blank value exceeds sample value.
Cause 1) Dirty HGB flow cell
2) Bubbles mixed in HGB sample line
3) Dirty WBC TD chamber
Action 1) Clean Transducer
Press [1] key to execute the transducer rinse sequence.
Refer to Chapter 4, Section 5.2: Clean Transducer.
Analysis after error
occurrence
Ready for analysis (although the next sample could be affected)
NOTE: • Press [3] key to return to the Analysis screen. Although the system
is ready for analysis, the error may occur in the next analysis.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-21
Error Message Meaning of Message
"Analysis Error"
ERR CODE:XXXXX.X.X
*Help*
3:Return
WBC/HGB Analysis Error
WBC (including HGB) analysis error is
continuing.
Cause 1) Faulty lyse (STROMATOLYSER-WH)
Action 1) Replenish Lyse
After replenishing lyse, always execute "4: Replace Reagent" in
the Select Menu, making reference to Chapter 4, Section 8.1:
Replenish Reagent. After replenishment and checking, analyze
the control blood and confirm that there is no abnormality.
Analysis after error
occurrence
Ready for analysis (although the next sample could be affected)
NOTE: • Press [3] key to return to the Analysis screen. Although the system
is ready for analysis, the error may occur in the next analysis.
TROUBLESHOOTING
7-22 Sysmex KX-21N Operator’s Manual -- October 1999
Error Message Meaning of Message
"Analysis Error"
ERR CODE:XXXXX.X.X
*Help*
3:Return
Abnormal detection sensitivity
Sensitivity in the transducer exceeds the
prescribed range.
Cause 1) Faulty diluent (CELLPACK)
Action 1) Replenish Diluent
After replenishing diluent, execute "5: Auto Rinse" in the Select
Menu, and perform background check. In addition, analyze the
control blood to see that there is no abnormality.
Analysis after error
occurrence
Ready for analysis (although the next sample could be affected)
NOTE: • Press [3] key to return to the Analysis screen. Although the system
is ready for analysis, the error may occur in the next analysis.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-23
3.7 Memory Errors
Error Message Meaning of Message
"Memory Error"
ERR CODE:XXXXX.X.X
*Help*
Memory error occurred.
Turn OFF then ON the power.
Error occurs on the Read Only Memory (ROM)
or Random Access Memory (RAM). The alarm
keeps sounding.
Cause 1) Momentary power failure, sudden noise interference, etc. causes
CPU malfunction.
Action 1) Turn OFF then ON the power again.
Analysis after error
occurrence
Inoperative (The power could be turned OFF.)
Error Message Meaning of Message
"Set Value Error"
ERR CODE:XXXXX.X.X
*Help*
Memory error occurred.
Stored data,and
QC data
will be repaired.
Repairing may end incomplete.
2 Deleting files and initializing.
[1]
[2]
1:Repairing 2:Initialize
Errors occur in the set values of the following:
• Stored data
• Quality Control data
• Customer-set values
Cause 1) Momentary power failure, sudden noise interference, etc. causes
analysis value errors.
Action 1) Repair
Press [1] key to execute repairing.
2) Initializing
If execution of "1: Repairing" fails to correct the error, initialize
using [2] key. Initializing deletes all stored data and QC data, and
set values return to initial values.
After completion of initializing, perform all settings referring to Chapter
10: INSTRUMENT SETUP.
Analysis after error
occurrence
Not Ready until the error is resolved.
TROUBLESHOOTING
7-24 Sysmex KX-21N Operator’s Manual -- October 1999
Error Message Meaning of Message
"Set Value Error"
ERR CODE:XXXXX.X.X
*Help*
Memory error occurred.
Turn OFF then ON the power.
Errors occur in the set values of the following:
• Stored data
• Quality Control data
• Customer-set values
• Factory-set values
Cause 1) Momentary power failure or sudden noise interference causes set
value errors.
Action 1) Turn OFF then ON the power again.
If the error persists even after the power is turned OFF then ON,
contact your Sysmex service representative for assistance.
Analysis after error
occurrence
Inoperative (The power could be turned OFF.)
Error Message Meaning of Message
Momentary Power Failure
Momentary power failure occurred, or
[SHUT DOWN]has not been performed
in the last time.
Perform[SHUT DOWN]in prior to
turning OFF the power.
Continue to start up.
1:Continue
[1]
The program had not been normally quitted the
last time the power was turned off.
Cause 1) Momentary power failure, etc. caused the unit to stop temporarily.
2) Shutdown had not been performed the last time the unit was
turned OFF.
Action Press [1] key to start up the unit. Perform SHUTDOWN before turning
OFF the power.
Analysis after error
occurrence
Ready for analysis (This error occurs at starting.)
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-25
3.8 Others
Error Message Meaning of Message
"QC Error"
ERR CODE:XXXXX.X.X
*Help*
3:Return
QC data falls out of control limits.
This error occurs only when executing Quality
Control.
Analysis data is out of QC limits.
Cause 1) Control blood aspiration error
2) Control blood insufficient mixing
3) Faulty control blood
4) Instrument failure
Action 1) Reanalyze Control Blood
Press [3] key to return to the QC screen and perform reanalysis.
2) Analyze using New Vial.
3) Maintenance Service of Unit
When the above 1) and 2) steps fail to resolve the error, a hardware
problem may be suspected. Refer to Chapter 4: INSTRUMENT
MAINTENANCE AND SUPPLIES REPLACEMENT and clean the
transducer, SRV, etc.
Analysis after error
occurrence
Ready for analysis
TROUBLESHOOTING
7-26 Sysmex KX-21N Operator’s Manual -- October 1999
Error Message Meaning of Message
"Calibration Error"
ERR CODE:XXXXX.X.X
*Help*
Calibration value is out of range.
If error persists,
>=5% difference from the last calib.
Calib. factor is out of 80%-120%.
3:Return
The set calibration value does not meet the
conditions:
• Difference from the last calibration must not
exceed 5%.
• Calibration value must be in the range of
80% - 120%.
Cause 1) Input error of target or calibration values
2) Instrument failure caused data to shift.
Action 1) Checking Entered Values
Press [3] key to return to the Calibration screen and check the
target or calibration value.
• In case of input error of target value in automatic calibration
Select "No" on the Update screen for calibration value and
execute Auto Calibration again from the beginning.
• In case of input error of calibration value in manual calibration
Select "No" on the Update screen for calibration value and enter
calibration value again.
2) Maintenance of Instrument
Check QC data, and if data is found to have shifted, a hardware
problem is conceivable. Referring to Chapter 4: INSTRUMENT
MAINTENANCE AND SUPPLIES REPLACEMENT, clean the
transducer, SRV, etc.
Analysis after error
occurrence
Not Ready until calibration value is fixed.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-27
3.9 Maintenance Errors
Error Message Meaning of Message
*Scheduled Maint.*
1:Exec.Clean
Clean the SRV.
Cycle No. after cleaning. 7567
Date last serviced 1/12/1999
Reset the cycle counter for SRV,
and you can turn OFF the power.
[1]
[3] Continue to start up. SRV cycle
counter will not be reset.
3:Cancel
It is time to clean the SRV.
Three months have passed from the previous
cleaning.
7500 samples have been analyzed from the
previous cleaning.
Cause
Action Press [1] key. Following the instructions on the screen, turn OFF the
power and clean the sample rotor valve (SRV). (Refer to Chapter 4:
Section 6.1: Clean Sample Rotor Valve (SRV) ).
If you perform cleaning later, press [3] key. This activates the usual
startup sequence and makes the system Ready.
∗ The same message will appear the next time you start the unit; it will
be displayed at each startup until the cleaning is performed.
Analysis after error
occurrence
Ready for analysis
NOTE: • When you clean SRV without pressing [1] key, execute "7:
Maintenance," and then "3: Reset Counter" in the Select Menu.
TROUBLESHOOTING
7-28 Sysmex KX-21N Operator’s Manual -- October 1999
Error Message Meaning of Message
*Scheduled Maint*
1:Exec.Clean
Cycle No. after cleaning. 2567
Date last serviced 1/12/1999
3:Cancel
Clean the Waste Chamber.
It will take approx. 15 minutes.
It is time to clean the waste chamber.
One month has passed from the previous
cleaning.
2500 samples have been analyzed from the
previous cleaning.
Cause
Action Press [1] key. Following the instructions on the screen, clean the
waste chamber. (Refer to Chapter 4, Section 5.1: Clean Waste
Chamber ).
If you perform cleaning later, press [3] key. This activates the usual
startup sequence and makes the system Ready.
∗ The same message will appear the next time you start the unit; it will
be displayed at each startup until the cleaning is performed.
Analysis after error
occurrence
Ready for analysis
NOTE: • When the waste chamber rinse sequence has been completed, the
cycle counter is automatically reset.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-29
Error Message Meaning of Message
*Scheduled Maint*
1:Exec.Clean
Cycle No. after cleaning. 2567
Date last serviced 1/12/1999
3:Cancel
Clean the Transducer.
It will take approx. 7 minutes.
It is time to clean the transducer.
One month has passed from the previous
cleaning.
2500 samples have been analyzed from the
previous cleaning.
Cause
Action Press [1] key. Following the instructions on the screen, clean the
transducer (Refer to Chapter 4, Section 5.2: Clean Transducer).
If you perform cleaning later, press [3] key. This activates the usual
startup sequence and makes the system Ready.
∗ The same message will appear the next time you start the unit; it will
be displayed at each startup until the cleaning is performed.
Analysis after error
occurrence
Ready for analysis
NOTE: • When the transducer rinse sequence has been completed, the
cycle counter is automatically reset.
TROUBLESHOOTING
7-30 Sysmex KX-21N Operator’s Manual -- October 1999
3.10 Printer Errors
Error Message Meaning of Message
"Abnormal IP "
ERR CODE:XXXXX.X.X
*Help*
Error on IP
Press the paper guide lever down.
Restarting to print
Stop printing on IP
[1]
[3]
To make IP on-line,
press[SELECT], then
[Periph.Settings]
1:Printing 2:Paper Feed 3:Stop Output
The printer has an error.
Cause 1) The paper release lever is not in the secured position.
Action 1) Confirming the Printer
Check the printer, and make it to a normal status.
After checking, press [1] key to print the not completed data.
2) Make the Built-in Printer Off-line
Press [3] key to make the printer off-line. The main unit becomes
Ready but cannot print. When you want to try printing again, refer
to Chapter 10: INSTRUMENT SETUP and make settings for
connecting the printer.
Analysis after error
occurrence
Not Ready until the error is resolved.
For the built-in printer (IP), paper-feed can be performed by pressing
[2] key.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-31
Error Message Meaning of Message
"Abnormal GP, Abnormal DP "
ERR CODE:XXXXX.X.X
*Help*
## printout error
Check ##
Restart printing
Stop printing on ##
[1]
[3]
To make ## on-line
press[SELECT], then
[Periph.Settings]
1:Printing 2:Paper Feed 3:Stop Output
The printer has an error.
("GP" (graphic printer) or "DP" (data printer) is
displayed in "##" of the screen.)
Cause 1) The printer is not connected.
2) There is no power to the printer.
3) Abnormality of connected cable
Action 1) Confirming the Printer
Check the printer, and make it to a normal status.
After checking, press [1] key to print the not completed data
2) Make the Printer Off-line
Press [3] key to make the printer off-line. The main unit becomes
Ready but cannot print. When you want to try printing again, refer
to Chapter 10: INSTRUMENT SETUP and make settings for
connecting the printer.
Analysis after error
occurrence
Not Ready until the error is resolved.
TROUBLESHOOTING
7-32 Sysmex KX-21N Operator’s Manual -- October 1999
Error Message Meaning of Message
"Abnormal IP, Abnormal GP"
ERR CODE:XXXXX.X.X
*Help*
## paper empty
Restarting to print
Stop printing on ##
[1]
[3]
To make ## on-line,
press[SELECT], then
[Periph.Settings]
1:Printing 2:Paper Feed 3:Stop Output
Paper found empty .
("IP" (built-in printer) or "GP" (graphic printer) is
displayed in "##" of the screen.)
Cause 1) No printer paper in the printer
Action 1) Replace Print Paper
Refer to Chapter 4, Section 8.3: Replace Printer Paper. After
replacing, press [1] key to print the data that has not yet printed.
2) Make the Printer Off-line
When you press [3], the printer is made off-line. The main unit
becomes Ready but cannot print. When you want to try printing,
refer to Chapter 10: INSTRUMENT SETUP and make settings for
connecting the printer.
Analysis after error
occurrence
Not Ready until the error is resolved.
NOTE: • For the built-in printer (IP), paper-feed can be performed by
pressing [2] key.
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-33
3.11 External Device Errors
Error Message Meaning of Message
"Host Comm. Error"
ERR CODE:XXXXX.X.X
*Help*
Host Output Error
*Host ACK Time Out Error*
Check Host Condition
Retries to transmit to Host
Stop transmitting to Host
[1]
[3]
To make Host Computer on-line,
press[SELECT], then
[Periph.Settings]
1:Re-sending 3:Stop Output
Communications cannot be made with the host
computer. There are four cases:
• Host Off-line
• Host ACK Time Out Error
• Host NAK Retry Error
• Host Transmission Time Out Error
Cause 1) Computer connecting cable failure
2) Computer is not turned ON or not ready for communication.
3) Host computer serial interface error
Action 1) Inspect Host Computer Cable
2) Inspect Connection Cable
When you press [1] key after inspection, data transmission is
resumed.
3) Disconnecting Host Computer
When you press [3] key, transmission to the host computer is
canceled and the host is off-lined in the main unit. The main unit is
now Ready but cannot output to the host computer.
To resume transmission to the host computer, refer to Chapter 10:
INSTRUMENT SETUP and make settings for connecting the host
computer.
Analysis after error
occurrence
Not Ready until the error is resolved.
TROUBLESHOOTING
7-34 Sysmex KX-21N Operator’s Manual -- October 1999
4 . STATUS DISPLAY
The unit has the Status Display screen by which you can confirm the status of the instrument.
The Status Display screen displays in real time a currently-running sequence,
pressure/vacuum readings, sensor status, and solenoid valve operating status. You can also
confirm on the screen HGB Converted value, cycle Nos. after performing the last
maintenance, and currently-registered cycle No.
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance."
(3) Press [ENTER] key. The Maintenance Menu screen appears.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
Figure 7-4-1: Maintenance Menu Screen
(4) Using [ ] key or [ ] key, move the cursor to select "5: Status Display."
(5) Press [ENTER] key. The Status Display screen appears.
NOTE: • On the Menu screen, each menu can be selected directly by entering a
numeral from the numeric keys.
The Status Display screen comprises two pages; you can turn over the pages using
[ ] key or [ ] key.
Page Selection in Status Dislay Screen
P1. Status Display Screen 1 P2. Status Display Screen 2
Figure 7-4-2: Page Selection in Status Display Screen
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-35
SEQ.No. 12
1 2 3 4
SV 1 2 3 4 5 6 7 8 9 0
SENSOR 1 2 3 4 5 6 7
HGB CONVERT 550
VACUUM 0.0320
1 2 3 4 5 6 7 8 9 0
PRESSURE 0.051
WB
0.0333 MPa Vacuum
HGB Converted Value
Sensor status
Solenoid valve operating status
Change screen with [ ] or [ ]
Ready
*Status*
Sequence No.
0.05 MPa Pressure
Figure 7-4-3: P1. Status Display Screen 1
*Status*
COUNTER 1234567
SRV 7567
DETECTOR 2567
WASTE CHAMBER 2567
WB
Cycle No. after cleaning waste chamber
Cycle No.
Cycle No. after cleaning transducer
Cycle No. after cleaning SRV
Change screen with [ ] or [ ]
Ready
Figure 7-4-4: P2. Status Display Screen 2
Sysmex KX-21N Operator’s Manual -- Revised February 2000
TROUBLESHOOTING
7-36 Sysmex KX-21N Operator’s Manual -- October 1999
5 . ERROR HISTORY PRINT
Recent occurred ten times error history can be printed from the built-in printer.
Execution of Error History Print
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance."
(3) Press [ENTER] key. The Maintenance Menu screen appears.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
Figure 7-5-1: Maintenance Menu Screen
(4) Using [ ] key or [ ] key, move the cursor to select "6: Print Error History."
(5) Press [ENTER] key. The built-in printer prints the error history.
Print Example
....
Date 31/12/2000
Time 23:59
*Error History*
Date 31/12/2000
Time 13:00
Pressure/Vac Error
XXXXXX.XXXXXX.XXXXXX
Date 24/12/2000
Time 09:15
Waste Not Draining
XXXXXX.XXXXXX.XXXXXX
Date 24/12/2099
Time 12:30
Host Comm. Error
XXXXXX.XXXXXX.XXXXXX
Figure 7-5-2: Error History Print
TROUBLESHOOTING
Sysmex KX-21N Operator’s Manual -- October 1999 7-37
6 . PROGRAM VERSION
This menu can be used to display the program version.
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance."
(3) Press [ENTER] key. The Maintenance Menu screen appears.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
Figure 7-6-1: Maintenance Menu Screen
(4) Using [ ] key or [ ] key, move the cursor to select "7: Program Version."
(5) Press [ENTER] key. The Program Version screen appears.
Program Version [1KXNF ##-##]
*Program Version*
Figure 7-6-2: Program Version Screen
Sysmex KX-21N Operator’s Manual -- Revised February 2000
CHAPTER 8 ADJUSTMENT
1. INTRODUCTION................................................................. 8-1
2. ADJUSTMENT OF PRESSURE AND VACUUM........................... 8-2
2.1 Location of Control Knobs................................................ 8-2
2.2 Pressure and Vacuum Display ............................................ 8-3
2.3 Adjusting Pressure to 0.05 MPa.......................................... 8-5
2.4 Adjusting Vacuum to 0.0333 MPa ....................................... 8-6
ADJUSTMENT
Sysmex KX-21N Operator’s Manual -- Revised February 2000 8-1
1 . INTRODUCTION
The adjustment procedures described here are important in maintaining accuracy of this
instrument. Your Sysmex service representative will perform initial adjustment. Should it
require any adjustment subsequently, follow the procedures given below.
The following adjustment procedures are explained in this chapter.
• Pressure: 0.05 MPa
• Vacuum: 0.0333 MPa
ADJUSTMENT
8-2 Sysmex KX-21N Operator’s Manual -- Revised February 2000
2 . ADJUSTMENT OF PRESSURE AND VACUUM
Pressure and vacuum from the built-in Pneumatic Unit are regulated to 0.05 MPa and 0.0333
MPa. The pressure and vacuum are always monitored by pressure sensors. When an error
occurs, an error message is displayed.
If the pressure or vacuum error message is displayed, check tubing connections or the like
for any air leakage. If there is no such error, display the Status Display screen and adjust
pressure or vacuum as required.
2.1 Location of Control Knobs
0.05 MPa Regulator
0.0333 MPa Bellows Unit
Figure 8-2-1: Location of Control Knobs
NOTE: • When an error has occurred, press [HELP] key to check pressure or
vacuum value on the Help screen.
(Refer to Chapter 7: TROUBLESHOOTING.)
*Help*
0.05 MPa Pressure Error
0.034 [0.039 - 0.059]
ERR CODE: XXXX.X.X
Adjust 0.05 MPa Pressure
1 Restarting to monitor the pressure
1:End of Adj
Figure 8-2-2: Help Screen
ADJUSTMENT
Sysmex KX-21N Operator’s Manual -- Revised February 2000 8-3
2.2 Pressure and Vacuum Display
(1) Press [SELECT] key when the status is "Ready." The Select Menu screen appears.
(2) Move the cursor using [ ] key or [ ] key, and select "7: Maintenance."
(3) Press [ENTER] key.
The Maintenance Menu screen appears.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
Figure 8-2-3: Maintenance Menu Screen
(4) Move the cursor using [ ] key or [ ] key, and select "5: Status Display."
(5) Press [ENTER] key.
The Status Display screen appears.
SEQ.No. 12
1 2 3 4
SV 1 2 3 4 5 6 7 8 9 0
SENSOR 1 2 3 4 5 6 7
HGB CONVERT 550
VACUUM 0.0320
1 2 3 4 5 6 7 8 9 0
PRESSURE 0.051
WB
Ready
*Status*
Change screen with [ ] or [ ]
Figure 8-2-4: Status Display Screen
NOTE: • Each menu can be selected directly on the Menu screen by entering a
numeral from the numeric keys.
ADJUSTMENT
8-4 Sysmex KX-21N Operator’s Manual -- Revised February 2000
NOTE: • The Status Display screen shows current pressure and vacuum.
SEQ.No. 12
1 2 3 4
SV 1 2 3 4 5 6 7 8 9 0
SENSOR 1 2 3 4 5 6 7
HGB CONVERT 550
VACUUM 0.0320
1 2 3 4 5 6 7 8 9 0
PRESSURE 0.051
WB
Ready
*Status*
Vacuum: 0.0333 MPa
(displaying 0.0320 MPa)
Pressure: 0.05 MPa
(displaying 0.051 MPa)
Change screen with [ ] or [ ]
Figure 8-2-5: Status Display Screen
(6) Adjust the pressure and vacuum by following the procedures given on the next page
and later.
ADJUSTMENT
Sysmex KX-21N Operator’s Manual -- Revised February 2000 8-5
2.3 Adjusting Pressure to 0.05 MPa
(1) Using the procedure of "2.2 Pressure and vacuum Display," display the Status Display
screen.
(2) Loosen the 0.05 MPa regulator locking nut on the left side of the unit.
(3) While watching the pressure and vacuum indication on the Status Display screen, turn
the adjusting knob to regulate pressure and vacuum. Turn the adjusting knob
clockwise to increase pressure and vacuum.
Adjustment range: 0.05±0.01 MPa
Low
High
Locking nut
Adjusting knob
Loosen
Figure 8-2-6: Adjusting the Pressure
CAUTION: • Always adjust pressure and vacuum so as to increase to the
predetermined levels. Should any of them be too high, lower it to
below that level once, then raise it to the set level. Unless adjustment
is properly conducted, accurate adjustment may not be possible.
(4) When adjustment is finished, tighten the locking nut while taking care not to allow the
adjusting knob to rotate.
(5) Press [SELECT] key to return to the Ready status.
ADJUSTMENT
8-6 Sysmex KX-21N Operator’s Manual -- Revised February 2000
2.4 Adjusting Vacuum to 0.0333 MPa
(1) Using the procedure of "2.2 Pressure and Vacuum Display," display the Status
Display screen.
(2) By turning counterclockwise, loosen the locking nut for the bellows unit on the left
side of the unit.
(3) While watching the pressure and vacuum indication on the Status Display screen, turn
the adjusting knob to regulate pressure and vacuum. Turn the adjusting knob
clockwise to increase pressure and vacuum.
Adjustment range: 0.0333±0.0013 MPa
HighLow
Locking nut
Adjusting knob
Loosen
Figure 8-2-7: Adjusting the Vacuum
CAUTION: • Always adjust pressure and vacuum so as to increase to the
predetermined levels. Should any of them be too high, lower it to
below that level once, then raise it to the set level. Unless adjustment
is properly conducted, accurate adjustment may not be possible.
(4) When adjustment is finished, tighten the locking nut while taking care not to allow the
adjusting knob to rotate.
(5) Press [SELECT] key to return to the Ready status.
Sysmex KX-21N Operator’s Manual -- October 1999
CHAPTER 9 FUNCTIONAL DESCRIPTION
1. INTRODUCTION ................................................................. 9-1
2. DETECTION PRINCIPLE ....................................................... 9-2
2.1 DC Detection Method....................................................... 9-2
2.2 Non-Cyanide Hemoglobin Analysis Method ............................ 9-2
3. MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM ...... 9-4
4. CBC ANALYSIS .................................................................. 9-5
4.1 WBC/HGB Analysis Flow ................................................ 9-5
4.2 RBC/PLT Analysis Flow .................................................. 9-7
4.3 Calculation of RBC Constant.............................................. 9-9
5. BLOOD CELL DISCRIMINATION CIRCUIT.............................. 9-10
5.1 WBC Discriminator....................................................... 9-10
5.2 RBC Discriminator........................................................ 9-10
5.3 PLT Discriminator ........................................................ 9-10
6. ANALYSIS OF HISTOGRAM ................................................ 9-11
6.1 Analysis of WBC Histogram ............................................ 9-11
6.2 Analysis of RBC/PLT Histogram....................................... 9-20
7. ELECTRIC SYSTEM ........................................................... 9-28
8. NAMES AND FUNCTIONS OF INSTRUMENTS ........................ 9-30
8.1 Front Panel................................................................. 9-30
8.2 Front Interior .............................................................. 9-31
8.3 Right Side Panel........................................................... 9-32
8.4 Left Side Panel ............................................................ 9-33
8.5 Left Side Interior .......................................................... 9-34
8.6 Rear Panel.................................................................. 9-35
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-1
1 . INTRODUCTION
This chapter describes blood cell count detection principle and analysis method used in this
instrument, and flow of individual analysis. Also the hardware elements are explained.
• Detection Principle: Principle each of DC detection method and non-cyanide
hemoglobin analysis method is described.
• Flow of Analysis: Flow of each analysis parameter on the main unit and
analysis method for particle distribution are described.
• Function of Measuring Unit: Names and functions of the measuring unit's elements
are briefly described.
FUNCTIONAL DESCRIPTION
9-2 Sysmex KX-21N Operator’s Manual -- October 1999
2 . DETECTION PRINCIPLE
This instrument performs blood cell count by DC detection method.
2.1 DC Detection Method
Blood sample is aspirated, measured to a predetermined volume, diluted at the specified
ratio, then fed into each transducer. The transducer chamber has a minute hole called the
aperture. On both side of the aperture, there are the electrodes between which flows direct
current. Blood cells suspended in the diluted sample pass through the aperture, causing
direct current resistance to change between the electrodes. As direct current resistance
changes, the blood cell size is detected as electric pulses.
Blood cell count is calculated by counting the pulses, and a histogram of blood cell sizes is
plotted by determining the pulse sizes. Also, analyzing a histogram makes it possible to
obtain various analysis data.
Internal Electrode -
External Electrode +
Blood Cell Suspension
Aperture
DC Supply
Resistance
DC
Transducer Chamber
Figure 9-2-1: DC Detection Method
2.2 Non-Cyanide Hemoglobin Analysis Method
To analyze hemoglobin by automated methods, the Cyanmethemoglobin method or
Oxyhemoglobin method have so far been the main stream.
Cyanmethemoglobin method was recommended as the international standard method in 1966
by ICSH (International Committee for Standardization in Hematology). This method,
however, is so low in hemoglobin conversion rate that it cannot be said an appropriate
method in the automated process in which multi-sample processing is the pre-condition. In
addition, this method uses the reagent of cyanide compound which is a poisonous substance
and requires waste processing; thus, it can hardly be called an environmentally favorable
method.
At present, this method cannot be said suitable for a fully-automated instrument which is
required to handle a large amount of waste.
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-3
The Oxyhemoglobin method, on the other hand, is faster in hemoglobin conversion rate; in
fact, blood hemoglobin is converted instantaneously into oxyhemoglobin. Also, it does not
contain poisonous substance as cyanmethemoglobin method, making the method suitable for
automation. This method, however, is unable to convert methemoglobin into
oxyhemoglobin. Consequently, when a great amount of methemoglobin is contained as in
control blood, lower-than-real values result, although usual human blood poses no
problems.
Non-cyanide hemoglobin analysis method utilizes the advantages of both of the above
methods. Non-cyanide hemoglobin analysis method rapidly converts blood hemoglobin as
the Oxyhemoglobin method and contains no poisonous substance, making it suitable for
automated method.
Being capable of analyzing methemoglobin, this method can accurately analyze control
blood, etc. which contain methemoglobin.
FUNCTIONAL DESCRIPTION
9-4 Sysmex KX-21N Operator’s Manual -- October 1999
3 . MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM
<Whole Blood Mode>
SampleRotorValve
(SRV)
Diluent
WBC/HGB Lyse
1.996 mL
1.960 mL
1.994 mL
1.0 mL
4.0 µL (1:500)
6 µL
40 µL (1:25000)
(1:500)
(1:500)
Whole Blood Sample (50 µL)
Mixing Chamber
RBC
TD Chamber
WBC
TD Chamber
HGB Flow Cell
Figure 9-3-1: Hydraulic System in Whole Blood Mode
<Pre-diluted Mode>
1.99792 mL
2.08 µL
1.922 mL
78 µL
1.0 mL
SampleRotorValve
(SRV)
Diluent
WBC/HGB Lyse
(1:1000)
(1:1000)
(1:25000)
1:26 Diluted Sample (200 µL)
Mixing Chamber
RBC
TD Chamber
WBC
TD Chamber
HGB Flow Cell
Figure 9-3-2: Hydraulic System in Pre-diluted Mode
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-5
4 . CBC ANALYSIS
4.1 WBC/HGB Analysis Flow
In WBC and HGB analysis, the volume of WBC and hemoglobin in the blood are measured.
The flow of WBC/HGB analysis is described below:
WBC Transducer
Sample Rotor Valve
Whole Blood Mode : Diluent 1.994 mL
Whole Blood 6 µL
Pre-diluted Mode : Diluent 1.922 mL
1:26 Diluted Sample 78 µL
Whole Blood Mode 1 mL
Pre-diluted Mode 1 mL
WBC/HGB Lyse:
Whole Blood Mode 1.0 mL
Pre-diluted Mode 1.0 mL
HGB Flow Cell
Tube or Microtube
Whole Blood Mode: 50 µL
Pre-diluted Mode: 1:26 Diluted Sample 200 µL
Diluent: 2.0 mL
Figure 9-4-1: WBC/HGB Analysis Flow
• Whole Blood Mode
(1) Blood is aspirated from the sample probe into the sample rotor valve.
(2) 6 µL of blood measured by the sample rotor valve is transferred to the WBC
transducer chamber along with 1.994 mL of diluent. At the same time, 1.0 mL of
WBC/HGB lyse is added to prepare 1:500 dilution sample.
When the solution is made to react in this status for approximately 10 seconds, RBC is
hemolyzed and platelets shrink, with WBC membrane held as they are. At the same
time, hemoglobin is converted into red colored methemoglobin.
(3) Of the diluted/hemolyzed sample in the WBC transducer chamber, approximately 1 mL
is transferred to the HGB flow cell.
FUNCTIONAL DESCRIPTION
9-6 Sysmex KX-21N Operator’s Manual -- October 1999
(4) 500 µL of sample in the WBC transducer is aspirated through the aperture. The pulses
of the blood cells when passing through the aperture are counted by the DC detection
method.
(5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting
diode (LED) is applied to the sample in the HGB flow cell. Concentration of this
sample is measured as absorbance. This absorbance is compared with that of the
diluent alone that was measured before addition of the sample, thereby calculating
HGB (hemoglobin value).
• Pre-diluted Mode
(1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. This
sample is aspirated from the sample probe into the sample rotor valve.
(2) 78 µL of diluted blood measured by the sample rotor valve is transferred to the WBC
transducer chamber along with 1.922 mL of diluent. At this time, 1.0 mL of
WBC/HGB lyse is added to prepare 1:1000 dilution sample.
When the solution is made to react in this status for approximately 10 seconds, RBC is
hemolyzed and platelets shrink, with WBC membrane held as they are. At the same
time, hemoglobin is converted into red colored methemoglobin.
(3) Of the diluted/hemolyzed sample in the WBC transducer chamber, approximately 1 mL
is transferred to the HGB flow cell.
(4) 500 µL of sample in the WBC transducer chamber is aspirated through the aperture.
The pulses of the blood cells when passing through the aperture are counted by the DC
detection method.
(5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting
diode (LED) is applied to the sample in the HGB flow cell. Concentration of this
sample is measured as absorbance. This absorbance is compared with that of the
diluent alone that was measured before addition of the sample, thereby calculating
HGB (hemoglobin value).
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-7
4.2 RBC/PLT Analysis Flow
In RBC/PLT analysis, RBC and platelet count in the blood are measured. The flow of
RBC/PLT analysis is described below:
• Whole Blood Mode
Mixing Chamber
(1:500 Diluted Sample: 40 µL)
Tube
(Whole Blood: 50 µL)
Sample Rotor Valve
Diluent: 2.0 mL Diluent 1.996 mL
Whole Blood 4 µL
Diluent 1.960 mL
1:500 Diluted Sample 40 µL
RBC/PLT Transducer
Figure 9-4-2: RBC/PLT Analysis Flow in Whole Blood Mode
(1) Blood is aspirated from the sample probe into the sample rotor valve.
(2) 4.0 µL of blood measured by the sample rotor valve is diluted into 1:500 with 1.996
mL of diluent and brought to the mixing chamber as diluted sample. (1st step dilution)
(3) Out of the 1:500 dilution sample, 40 µL is measured by the sample rotor valve, diluted
into 1:25000 with 1.960 mL of diluent, then transferred to the RBC/PLT transducer
chamber. (2nd step dilution)
(4) 250 µL of the sample in the RBC/PLT transducer chamber is aspirated through the
aperture. At this time, RBC and PLT are counted by the DC detection method.
At the same time, HCT (hematocrit value) is calculated by RBC pulse height detection
method.
FUNCTIONAL DESCRIPTION
9-8 Sysmex KX-21N Operator’s Manual -- October 1999
• Pre-diluted Mode
Microtube
(1:26 Diluted Sample: 200 µL)
RBC/PLT Transducer
Diluent 1.99792 mL
1:26 Diluted Sample 2.08 µL
Sample Rotor Valve
Diluent : 2.0 mL
Figure 9-4-3: RBC/PLT Analysis Flow in Pre-diluted Mode
(1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. This
sample is aspirated from the sample probe into the sample rotor valve.
(2) 2.08 µL of diluted blood measured by the sample rotor valve is transferred in 1.99792
mL of diluent to the RBC/PLT transducer chamber, and is made into 1:25000 dilution
sample.
(3) Of the sample in the RBC/PLT transducer chamber, 250 µL is aspirated through the
aperture. At this time, RBC and PLT are calculated by the DC detection method. At
the same time, HCT (hematocrit value) is calculated by RBC pulse height detection
method.
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-9
4.3 Calculation of RBC Constant
RBC constant (mean RBC volume, mean RBC hemoglobin, mean RBC hemoglobin
concentration) is calculated from RBC, HGB, and HCT.
1. Mean RBC Volume (MCV)
Calculation is made from RBC and HCT by the formula below:
MCV (fL) =
HCT (%)
RBC (×10
6
/µL)
×10
2. Mean RBC Hemoglobin (MCH)
Calculation is made from RBC and HGB by the formula below:
MCH (pg) =
HGB (g/dL)
RBC (×10
6
/µL)
×10
3. Mean RBC Hemoglobin Concentration (MCHC)
Calculation is made from HCT and HGB by the formula below:
MCHC (g/dL) =
HGB (g/dL)
HCT (%)
×100
FUNCTIONAL DESCRIPTION
9-10 Sysmex KX-21N Operator’s Manual -- October 1999
5 . BLOOD CELL DISCRIMINATION CIRCUIT
WBC, RBC, and PLT are discriminated and calculated by the following blood cell
discriminator.
5.1 WBC Discriminator
As to WBC LOWER discriminator, the optimum position in 30 - 60 fL is automatically
determined by the microcomputer. WBC is calculated from the particle counts more than this
LOWER discriminator.
5.2 RBC Discriminator
As to RBC LOWER discriminator and UPPER discriminator, the optimum position in 25 -
75 fL and 200 - 250 fL, respectively, are automatically determined by the microcomputer.
RBC is calculated from the particle counts between this LOWER discriminator and UPPER
discriminator.
5.3 PLT Discriminator
As to PLT LOWER discriminator and UPPER discriminator, the optimum position in 2 - 6
fL and 12 - 30 fL, respectively, are automatically determined by the microcomputer. PLT
count is calculated from the particle counts between this LOWER discriminator and UPPER
discriminator.
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-11
6 . ANALYSIS OF HISTOGRAM
Analysis of histogram allows use of the flagging system that suggests sample error or
instrument error.
Histograms of WBC, RBC, and PLT can be calculated respectively within the ranges given
below.
WBC: Approx. 30 - 300 fL (particle after lyse dripping)
RBC: Approx. 25 - 250 fL
PLT: Approx. 2 - 30 fL
6.1 Analysis of WBC Histogram
1 . WBC Histogram
The WBC histogram is discriminated into small, middle, and large WBC by 3-part
differential method using 4 discriminators. The LOWER discriminator (LD) is
automatically determined at an optimum position between 30 and 60 fL. The UPPER
discriminator (UD) is fixed at 300 fL, which is used as the monitor for histogram
error. The WBC histogram troughs in the (LD)-to-(UD) range are determined; the 1st
one is defined TROUGH Discriminator 1 (T1) and the 2nd one TROUGH
Discriminator 2 (T2).
• WBC Histogram
300
WBC
UD
Lymphocytes Mixed cells Neutrophils
200100
LD T1 T2
[fL]
Figure 9-6-1: WBC Histogram
1 ) LYM# [W-SCC (WBC-Small Cell Count) ]
Lymphocytes between discriminator (LD) and (T1), which is considered highly
correlated with lymphocyte count.
2 ) MXD# [W-MCC (WBC-Middle Cell Count) ]
Mixed cells between discriminator (T1) and (T2), which is considered highly
correlated with the sum of monocytes, basophils, and eosinophils.
3 ) NEUT# [W-LCC (WBC-Large Cell Count)]
Neutrophils more than discriminator (T2), which is considered highly correlated
with neutrophils.
FUNCTIONAL DESCRIPTION
9-12 Sysmex KX-21N Operator’s Manual -- October 1999
4 ) LYM% [W-SCR (WBC-Small Cell Ratio) ]
Ratio of lymphocytes to whole WBC
5 ) MXD% [W-MCR (WBC-Middle Cell Ratio) ]
Ratio of mixed cells to whole WBC
6 ) NEUT% [W-LCR (WBC-Large Cell Ratio) ]
Ratio of neutrophils to whole WBC
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-13
2 . WBC Histogram Error Flag
When the WBC histogram is normal with three peaks, there are a lower trough (T1)
and a higher trough (T2) between LOWER discriminator (LD) and UPPER
discriminator (UD).
• Output Example of Normal WBC Three-Peak Histogram
300
WBC
UD
200100
LD T1 T2
[fL]
WBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
6.7
28.3
17.4
54.3
1.9
1.2
3.6
[×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
Figure 9-6-2: Normal WBC Three-Peak Histogram
When TROUGH Discriminator (T1) or (T2) cannot be set or when frequency for a set
discriminator position is higher than the range, it is flagged as WBC histogram error.
Those histogram error flags are listed below in the order of higher priority. If more
than one flag are applied, the flag of the highest priority is taken.
WL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable
cause is inclusion of numerous platelet agglutinations, large platelets, and etc.
T1: Lower TROUGH Discriminator, that distinguishes lymphocytes and mixed cells,
cannot be not determined.
T2: Higher TROUGH Discriminator, that distinguishes mixed cells and neutrophils,
cannot be not determined.
F1: Small cell histogram error. Relative frequency for T1 exceeds the range.
F2: Middle cell histogram error. Relative frequency for T1 or T2 exceeds the range.
F3: Large cell histogram error. Relative frequency for T2 exceeds the range.
WU: Relative frequency for UPPER discriminator (UD) exceeds the range.
Applicable cases are those in which hemolysis is insufficient (for instance,
samples whose RBC membrane has extremely strong resistance against lyse) or
in which numerous abnormal blood cells are present.
AG: The particle count equal to or less than the LD exceeds a prescribed range.
Probable cause is platelet agglutination, which does not alter WBC count but
may result in decreased platelet count. Therefore, this flag is added to the PLT
parameter.
FUNCTIONAL DESCRIPTION
9-14 Sysmex KX-21N Operator’s Manual -- October 1999
• WBC and Calculation Parameters versus Analysis Value Error Flags
O
WBC Histogram Error Flag Output
[1] [2]
[1] : Output flag to LCD screen, printer.
[2] : Output flag to host computer.
O : Analysis result of each discriminator is normal
High : Frequency for each discriminator is higher than the range.
× : A trough is not clear and cannot be detected.
: Any of "O ," "×," and "High" is applicable.
Case
No. LD T1 T2 UD WBC LYM% MXD% NEUT% LYM# MXD# NEUT# HOST
1
2A
2B
3A
3B
3C
3D
4A
4B
4C
4D
5A
5B
6
High
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
O
OO
O
O
O
O
OO O
×
×
High
High
High
High
High
High
×
×
×
×
High
High
High
High
High
High
High
High
High
High
High
WL
WU
WU
WU
WU
WU
WU
WU
WL
T1
T1
F1
F1
F1
F1
F1
F1
WL
T1
T1
T2
T2
T2
T2
F2
F2
F2
F2
F2
F2
WL
T1
T1
T2
T2
T2
T2
F3
F3
F3
F3
WL
T1
T1
F1
F1
F1
F1
F1
F1
WL
T1
T1
T2
T2
T2
T2
F2
F2
F2
F2
F2
F2
WL
T1
T1
T2
T2
T2
T2
F3
F3
F3
F3
1
5
5
6
6
6
6
7
7
7
7
8
8
2
7 (The particle count equal to
or less than LD is higher than
the range)
PLT parameter is flagged with AG. 2
Table 9-6-1: WBC Histogram Error Flags
NOTE: • When analyzing in the pre-diluted mode, since CBC8 parameters only
are output, flagging is limited to a WBC parameter.
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-15
1 ) 1A Histogram having high LD frequency with troughs T1 and T2
WL flag is added to all WBC parameters (WBC, LYM%, MXD%, NEUT%,
LYM#, MXD#, NEUT#).
• WBC Histogram Error-WL (1A)
WBC
UDLD T1 T2
8.5
39.3
17.6
43.1
3.4
1.5
3.6
[×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
300200100 [fL]
WL
WL
WL
WL
WL
WL
WL
WBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Figure 9-6-3: WBC Histogram Error-WL (1A)
2 ) 1B Histogram with high LD and trough T1 but without T2
WL flag is added to all analysis results for WBC, LYM% and LYM#. WL flag
is added to mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#,
NEUT#) and their data are not output. ([---.-])
• WBC Histogram Error-WL (1B)
WL
WL
WL
WL
WL
WL
WL
WBC
UDLD T1
2.8
45.9
---.-
---.-
1.3
---.-
---.-
[×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
300200100 [fL]
WBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Figure 9-6-4: WBC Histogram Error-WL (1B)
3 ) 1C Histogram with high LD but without T1
WL flag is added to WBC and other parameters are not output. Note [+] on
WBC numeric data in the example below. This WBC value exceeds the upper
Patient Mark Limits mentioned earlier.
• WBC Histogram Error-WL (1C)
WL
WL
WL
WL
WL
WL
WL
WBC
UD
+16.4
---.-
---.-
---.-
---.-
---.-
---.-
LD
. [×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
300200100 [fL]
WBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Figure 9-6-5: WBC Histogram Error-WL (1C)
FUNCTIONAL DESCRIPTION
9-16 Sysmex KX-21N Operator’s Manual -- October 1999
4 ) 2A Histogram without T1
Although the histogram error flag is not added to WBC, all other parameters are
flagged with T1 and their data are not output. Note that WBC in the graph
exceeds the upper Patient Mark Limits.
• WBC Histogram Error-T1 (2A)
WBC
UDLD
+15.4
---.-
---.-
---.-
---.-
---.-
---.-
[×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
300200100 [fL]
T1
T1
T1
T1
T1
T1
WBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Figure 9-6-6: WBC Histogram Error-T1 (2A)
5 ) 2B Histogram having high UD but without T1
WBC is flagged with WU. All other parameters are flagged with T1 and their
data are not output.
6 ) 3A Histogram with high T1 but without T2
WBC is not flagged. F1 flag is added to lymphocyte parameters (LYM%,
LYM#). Mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#,
NEUT#) are flagged with T2 and their data are not output.
• WBC Histogram Error-T2 (3A)
WBC
UDLD T1
5.2
29.7
---.-
---.-
1.5
---.-
---.-
[×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
300200100 [fL]
F1
T2
T2
F1
T2
T2
WBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Figure 9-6-7: WBC Histogram Error-T2 (3A)
7 ) 3B Histogram with high T1 but without T2, and high in UD
frequency
WBC is flagged with WU and lymphocyte parameters (LYM%, LYM#) are
flagged with F1. Mixed cell and neutrophil parameters (MXD%, NEUT%,
MXD#, NEUT#) are flagged with T2 and their data are not output.
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-17
8 ) 3C Histogram with T1 but without T2
WBC and lymphocyte parameters (LYM%, LYM#) are not flagged as the
histogram error. Mixed cell and neutrophil parameters (MXD%, NEUT%,
MXD#, NEUT#) are flagged with T2 and data are not output.
WBC shown below exceeds the upper Patient Mark Limits.
• WBC Histogram Error-T2 (3C)
300
WBC
UDLD T1
[fL]
+15.2
12.9
---.-
---.-
1.6
---.-
---.-
[×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
200100
T2
T2
T2
T2
WBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Figure 9-6-8: WBC Histogram Error-T2 (3C)
9 ) 3D Histogram with high T1 but no T2, and with high UD
WBC is flagged with WU. Lymphocyte parameters (LYM%, LYM#) are not
flagged. Mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#,
NEUT#) are flagged with T2 and their data are not output.
10) 4A Histogram with high T1
WBC and neutrophil parameters (NEUT%, NEUT#) are not flagged.
Lymphocyte parameters (LYM%, LYM#) are flagged with F1 and mixed cell
parameters (MXD%, MXD#) are flagged with F2.
• WBC Histogram Error - F1 (4A)
WBC
LD T1 T2
6.7
28.3
17.4
54.3
1.9
1.2
3.6
UD
[×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
300200100 [fL]
F1
F2
F1
F2
WBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Figure 9-6-9: WBC Histogram Error - F1 (4A)
11) 4B Histogram with high T1 and UD
WBC is flagged with WU, lymphocyte parameters (LYM%, LYM#) are flagged
with F1, and mixed cell parameters (MXD%, MXD#) with F2. Neutrophil
parameters (NEUT%, NEUT#) are not flagged.
FUNCTIONAL DESCRIPTION
9-18 Sysmex KX-21N Operator’s Manual -- October 1999
12) 4C Histogram with high T1 and high T2
WBC is not flagged. Lymphocyte parameters (LYM%, LYM#) are flagged with
F1, mixed cell parameters (MXD%, MXD#) with F2, and neutrophil parameters
(NEUT%, NEUT#) with F3.
• WBC Histogram Error - F1 (4C)
WBC
UDLD T1 T2
10.7
20.8
11.2
68.0
2.2
1.2
7.3
[×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
300200100 [fL]
F1
F2
F3
F1
F2
F3
WBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Figure 9-6-10: WBC Histogram Error - F1 (4C)
13) 4D Histogram high in all T1, T2, and UD
WBC data are output with WU flag, lymphocyte parameters (LYM%, LYM#)
with F1 flag, mixed cell parameters (MXD%, MXD#) with F2 flag, and
neutrophil parameters (NEUT%, NEUT#) with F3 flag.
14) 5A Histogram with high T2
Histogram error flag is not added to WBC and lymphocyte parameters (LYM%,
LYM#). Mixed cell parameters (MXD%, MXD#) are flagged with F2, and
neutrophil parameters (NEUT%, NEUT#) with F3 flag. WBC and MXD%
exceed the upper Patient Mark Limits.
• WBC Histogram Error - F2 (5A)
WBC
UDLD T1 T2
+18.5
9.5
+23.7
66.8
1.1
2.7
7.7
[×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
300200100 [fL]
F2
F3
F2
F3
WBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Figure 9-6-11: WBC Histogram Error - F2 (5A)
15) 5B Histogram with high T2 and high UD
WBC is flagged with WU and lymphocyte parameters (LYM%, LYM#) are not
flagged. Mixed cell parameters (MXD%, MXD#) are flagged with F2, and
neutrophil parameters (NEUT%, NEUT#) with F3.
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-19
16) 6 Histogram with high UD
WBC is flagged with WU and other parameters are not flagged. WBC in this
instance exceeds the upper Patient Mark Limits.
• WBC Histogram Error - WU (6)
WBC
UDLD T1 T2
+ 15.4
24.5
7.5
68
3.3
1.0
8.1
[×103
/µL]
[%]
[%]
[%]
[×103
/µL]
[×103
/µL]
[×103
/µL]
300200100 [fL]
WUWBC
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Figure 9-6-12: WBC Histogram Error - WU (6)
17) 7 The particle count equal to or less than LD is higher than the
range.
PLT is flagged with AG and other parameters are not flagged.
FUNCTIONAL DESCRIPTION
9-20 Sysmex KX-21N Operator’s Manual -- October 1999
6.2 Analysis of RBC/PLT Histogram
1 . RBC Histogram
As mentioned earlier, RBC are determined as particle counts between two
discriminators (LD) and (UD) which are automatically counted in the ranges of 25 - 75
fL and 200 - 250 fL, respectively.
As to histogram, check is made for relative frequency errors on respective
discriminator levels, for more than one peak, and for distribution width error.
In addition, this instrument is capable of expressing RBC distribution width (RDW) by
two methods below:
RDW-CV (RBC Distribution Width - Coefficient of Variation) is calculated by the
formula below, after determining points L1 and L2 for 68.26% of the entire particle
area. The unit applied is %.
• Calculation of RDW-CV
RDW-CV (%) =
L2 - L1
L2 + L1
×100
L2L1
68.26% of Entire Distribution Area
Figure 9-6-13: Calculation of RDW-CV
RDW-SD (RBC Distribution Width - Standard Deviation) is set on 20% frequency
level with the peak taken as 100%. The unit applied is fL (femto-liter = 10-15
L).
• Definition of RDW-SD
100%
20%
RDW-SD
Figure 9-6-14: Definition of RDW-SD
Sysmex KX-21N Operator’s Manual -- Revised February 2000
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 9-21
2 . PLT Histogram
Platelet histogram is analyzed using three discriminators: two discriminators (LD) and
(UD) - determined automatically between 2 - 6 fL and between 12 - 30 fL, respectively
-and the fixed discriminator at 12 fL. Regarding PLT histogram, check is made to see
that there are no relative frequency errors at discriminators (LD) and (UD), distribution
width error, and there is a single peak.
1 ) MPV (Mean Platelet Volume)
MPV is calculated by the following formula:
MPV (fL) =
PCT (%)
PLT (×10
3
/µL)
×1000
Where PCT (%) represents the value weighted with PLT frequency and is called
platelet-crit or platelet volume ratio. The analysis method used is the same as
mentioned in HCT analysis principle 4.2 RBC/PLT Analysis Flow in this chapter.
FUNCTIONAL DESCRIPTION
9-22 Sysmex KX-21N Operator’s Manual -- October 1999
3 . RBC Histogram Error Flag
When RBC histogram is not normal, a histogram error flag is added to the
corresponding parameter of the analysis value. Those histogram error flags are listed
in the order of higher priority. When two or more flags are applicable to a parameter,
the highest-priority flag is used.
RL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable
cause is the effect of noise, RBC morphological change, platelet coagulation, or
the like.
RU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable
cause is the effect of noise.
MP: Two or more peaks in histogram.
DW: Particle distribution width error for 20% frequency with the peak taken as 100%.
When the 20% frequency does not cross the histogram two times, this flag is
attached.
• Matching of eight kinds of RBC histogram error flags
RBC Histogram Error Flag Output
[1] [2]
[1]: Output flag to LCD screen, printer.
[2]: Output flag to host computer.
O: • When analysis results of LD and UD are normal
• In the case of DW, when RDW-SD could be analyzed
• In the case of MP, when RBC histogram has a single peak
High: Frequencies of LD and UD are higher than the range
×: • In the case of DW, when RDW-SD could not be analyzed
• In the case of MP, when RBC histogram has two or more peaks
: Any of "O ," "×," and "High" is applicable.
Case
No. LD UD DW MP RBC HCT MCV MCH MCHC PLT
RDW
-SD
HOST
1A
1B
1C
2A
2B
2C
3
4
High
High
High
O
O
O
O
O
High
High
High
O
O
O
×
×
O
O
×
O
O
×
O
×
RL
RL
RL
RU
RU
RU
RL
RL
RL
RU
RU
RU
RL
RL
RL
RU
RU
RU
RL
RL
RL
RU
RU
RU
RL
RL
RL
RU
RU
RU
RL
RL
RL
RU
RU
RU
RL
DW
MP
RU
DW
MP
DW
MP
RDW
-CV
RL
RL
MP
RU
RU
MP
MP
1
1
1
2
2
2
3
4
O
×
Table 9-6-2: RBC Histogram Error Flags
NOTE: • Since CBC8 parameters only are output in the pre-diluted mode, a flag
is not output to RDW-SD or RDW-CV.
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 9-23
1 ) 1A Histogram with high frequency for LD
RBC, HCT, MCV, MCH, MCHC, PLT, and particle distribution width data
parameters are flagged with RL. MCV and RDW-SD exceed the upper Patient
Mark Limits, and MCHC falls below the lower Patient Mark Limits.
• RBC Histogram Error - RL (1A)
3.57
11.5
41.8
+117.1
32.2
-27.5
+91.7
185
[×106
/µL]
[g/dL]
[%]
[fL]
[pg]
[g/dL]
[fL]
[×103
/µL]
RBC
250200100 [fL]
RBC
HGB
HCT
MCV
MCH
MCHC
RDW-SD
PLT
RL
RL
RL
RL
RL
RL
RL
Figure 9-6-15: RBC Histogram Error - RL (1A)
2 ) 1B High frequency for LD with 20% particle distribution width
error
RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RL.
Of the particle distribution width data, RDW-CV is flagged with RL and its data
are output. RDW-SD parameter is flagged with DW and its data are not output.
3 ) 1C High LD with two or more peaks
RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RL.
RDW-CV is flagged with MP and its data are output, while RDW-SD is flagged
with MP but its data are not output.
4 ) 2A Frequency high for UD
RBC, HCT, MCV, MCH, MCHC, PLT, and particle distribution width data
parameters are flagged with RU. In this instance, flags to indicate that their data
are out of Patient Mark Limits are added to MCV, MCHC, and RDW-SD.
• RBC Histogram Error - RU (2A)
3.57
11.5
41.8
+117.1
32.2
-27.5
+91.7
185
RBC
[×106
/µL]
[g/dL]
[%]
[fL]
[pg]
[g/dL]
[fL]
[×103
/µL]
250200100 [fL]
RBC
HGB
HCT
MCV
MCH
MCHC
RDW-SD
PLT
RU
RU
RU
RU
RU
RU
RU
Figure 9-6-16: RBC Histogram Error - RU (2A)
FUNCTIONAL DESCRIPTION
9-24 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
5 ) 2B High UD with 20%-frequency distribution width error
RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged. Out of the
particle distribution width data, RDW-CV is flagged with RU and its data are
output.
RDW-SD is flagged with DW and its data are not output. In this instance, MCV
and MCHC are out of Patient Mark Limits.
• RBC Histogram Error - RU, DW (2B)
3.57
11.5
52.9
+148.2
32.2
-21.7
---.-
185
RBC
[×106
/µL]
[g/dL]
[%]
[fL]
[pg]
[g/dL]
[fL]
[×103
/µL]
250200100 [fL]
RBC
HGB
HCT
MCV
MCH
MCHC
RDW-SD
PLT
RU
RU
RU
RU
RU
DW
RU
Figure 9-6-17: RBC Histogram Error - RU, DW (2B)
6 ) 2C High UD with two or more peaks
RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RU.
As to particle distribution width data, RDW-CV is flagged with MP and its data
are output, while RDW-SD is also flagged with MP but its data are not output.
7 ) 3 20%-frequency particle distribution width error
RBC, HCT, MCV, MCH, MCHC, and PLT parameters are not flagged. As to
the particle distribution width data, RDW-CV data are output without flagging,
while RDW-SD data are flagged with DW and their data are not output.
8 ) 4 Two or more peaks
RBC, HCT, MCV, MCH, MCHC, and PLT parameters are not flagged. As to
the particle distribution width data, RDW-CV data are output with MP flag.
RDW-SD is flagged with MP and its data are not output. In this instance, RDW-
CV is out of Patient Mark Limits.
• RBC Histogram Error - MP (4)
4.80
14.2
41.5
86.5
29.6
-34.2
+33.3
216
RBC
[×106
/µL]
[g/dL]
[%]
[fL]
[pg]
[g/dL]
[%]
[×103
/µL]
250200100 [fL]
RBC
HGB
HCT
MCV
MCH
MCHC
RDW- CV
PLT
MP
Figure 9-6-18: RBC Histogram Error - MP (4)
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 9-25
4 . Platelet Histogram Error Flag
When the platelet histogram is not normal, a histogram error flag is added to the
corresponding parameter of the analysis value. Those histogram error flags - used
with the particle distribution analysis unit mounted, are listed in the order of higher
priority.
When two or more flags are applicable to a parameter, the highest priority flag is used.
PL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable
cause is the effect of noise and etc.
PU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable
cause is the effect of platelet agglutination, noise interference, and etc.
MP: Two or more peaks in histogram
DW: Particle distribution width error for 20% frequency with the peak taken as 100%.
When the 20% frequency does not cross the histogram two times, this flag is
attached.
• Matching of eight kinds of platelet histogram error flags
Platelet Histogram Error Flag Output
[1] [2]
[1]: Output flag to LCD screen, printer.
[2]: Output flag to host computer.
O: • When analysis results of LD and UD are normal
• In the case of MP, when PLT histogram has a single peak
High: Frequencies of LD and UD are higher than the range.
×: • In the case of MP, when PLT histogram has two or more peaks
: Any of "O ," "×," and "High" is applicable.
Case
No. LD UD DW MP PLT MPV HOST
1A
1B
1C
2A
2B
2C
3
4
High
High
High
O
O
O
O
O
High
High
High
O
O
O
×
×
O
O
×
O
O
×
O
×
PL
PL
PL
PU
PU
PU
PL
PL
PL
PU
PU
PU
DW
MP
1
1
1
2
2
2
3
4
O
×
Table 9-6-3: Platelet Histogram Error Flags
NOTE: • Since CBC8 parameters only are output in the pre-diluted mode, flag
output is limited to a PLT parameter.
FUNCTIONAL DESCRIPTION
9-26 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
1 ) 1A High frequency for LD
PLTM and MPV parameters are flagged with PL.
• Platelet Histogram Error - PL (1A)
211
12.5
9.3
-22.6
PLT
[×103
/µL]
[fL]
[fL]
[%]
302010 [fL]
PLT
PDW
MPV
P-LCR
PL
PL
PL
PL
Figure 9-6-19: Platelet Histogram Error - PL (1A)
2 ) 1B High LD with 20%-frequency distribution width error
PLT parameter is flagged with PL.
MPV is flagged with PL and its data is not output.
3 ) 1C High LD with two or more peaks
PLT parameter is flagged with PL.
MPV is flagged with PL and its data is not output.
4 ) 2A High UD
PLT and MPV parameters are flagged with PU.
5 ) 2B High UD with 20%-frequency particle distribution width error
PLT parameter is flagged with PU.
MPV is flagged with PU and its data is not output.
• Platelet Histogram Error - PU (2B)
171
---.-
---.-
---.-
PLT
[×103
/µL]
[fL]
[fL]
[%]
302010 [fL]
PLT
PDW
MPV
P-LCR
PU
DW
PU
PU
Figure 9-6-20: Platelet Histogram Error - PU (2B)
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 9-27
6 ) 2C High UD with two or more peaks
PLT parameter is flagged with PU.
MPV is flagged with PU and its data is not output.
7 ) 3 20%-frequency particle distribution width error
PLT is not flagged. MPV is flagged with DW and its data is not output.
• Platelet Histogram Error - DW (3)
91
---.-
---.-
---.-
PLT
[×103
/µL]
[fL]
[fL]
[%]
302010 [fL]
PLT
PDW
MPV
P-LCR
DW
DW
DW
Figure 9-6-21: Platelet Histogram Error - DW (3)
8 ) 4 Two or more peaks
PLT is not flagged. Other parameters are flagged with MP and their data are not
output.
• Platelet Histogram Error - MP (4)
155
---.-
---.-
---.-
PLT
[×103
/µL]
[fL]
[fL]
[%]
302010 [fL]
PLT
PDW
MPV
P-LCR
MP
MP
MP
Figure 9-6-22: Platelet Histogram Error - MP (4)
FUNCTIONAL DESCRIPTION
9-28 Sysmex KX-21N Operator’s Manual -- October 1999
7 . ELECTRIC SYSTEM
The microprocessor in the main unit controls the hydraulic system's solenoid valves and
master valves, thus regulating the flow of samples, reagents, and waste in the hydraulic
system.
Electric signals received from various transducers go through the analogue circuit for
electrical waveform-processing, and to the microcomputer. The microcomputer converts the
analogue signals into digital signals for the calculation.
The WBC, RBC, and PLT cell signals are sent to the respective waveform-processing
circuits in the analogue circuit, where the noise in signals is eliminated to acquire the required
cell signals only. The microcomputer converts the A/D-converted cell signals into particle
distribution data, and outputs them to the printer or to the host computer.
To calculate HGB, absorbance of only the diluent (background) is deducted from samples'
absorbance. The beam that has passed through the fluid is detected by the photo diode. And
the signals is photoelectrically converted, A/D converted, and then sent to the HGB counting
circuit for the calculation of the absorbance.
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-29
Electric Diagram
WBC
Transducer
WBCDetection
Circuit
WBC
Amplification
Waveform
Processing
Circuit
RBC,PLT
Transducer
RBC,PLT
DetectionCircuit
HGB
Transducer
HGB
Amplification
Circuit
WBCCountingCircuit
RBCCountingCircuit
PLTCountingCircuit
HGBCountingCircuit
WBCA-D
Conversion
Circuit
RBCA-D
Conversion
Circuit
PLTA-D
Conversion
Circuit
Pressure
Monitoring
Unit
Driver
Solenoid
Motor
Input-
Output
Interface
RBC
Amplification
Waveform
Processing
Circuit
PLT
Amplification
Waveform
Processing
Circuit
HGB
Conversion
Circuit
MicrocomputerCircuit
WBCCalculator RBCCalculator
AnalogueCircuit
LCD
Interface
Interface
Printer
Interface
LCDscreen
PanelSwitch
Built-inPrinter
MainUnit
Transducer
PDAUnit
SerialInterface
Memory
Processor
(Computer)
DisplayUnit
Operation
Unit
Built-in
Printer
Interface
Interface
Interface
Interface
Interface Interface
Bus
HandHeldBarcodeReader
GraphicPrinter
DataPrinter
(Option)
(Option)
(Option)
Figure 9-7-1: Electric Diagram
Sysmex KX-21N Operator’s Manual -- Revised February 2000
FUNCTIONAL DESCRIPTION
9-30 Sysmex KX-21N Operator’s Manual -- October 1999
8 . NAMES AND FUNCTIONS OF INSTRUMENTS
8.1 Front Panel
Sysmex
4) Graphic Screen
5) Panel Keyboard
1) Front Cover
2) Sample Probe
3) START switch
Figure 9-8-1: Front Panel
1 ) Front Cover
The front cover can be opened to the right by your hands. It is opened to replace lyse
containers, check or clean the interior of measuring unit.
2 ) Sample Probe
The sample probe is used to aspirate sample in the whole blood and pre-diluted modes.
3 ) START Switch
This switch starts whole blood mode analysis and pre-diluted mode analysis.
4 ) Graphic Screen
This displays Sample Nos., analysis results, instrument status, error messages, etc.
For detail, refer to Chapter 1, Section 8: GRAPHIC SCREEN.
5 ) Panel Keyboard
This keyboard allows basic operations such as entry of Sample No. and selection of
analysis parameters. For detail, refer to Chapter 1, Section 7: PANEL KEYBOARD.
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-31
8.2 Front Interior
1) Detector Block
5) Built-in Printer
2) Sample Rotor Valve (SRV)
3) Rinse Cup
4) WBC/HGB Lyse
(STROMATOLYSER-WH)
Figure 9-8-2: Front Interior
1 ) Detector Block
Incorporates RBC transducer, WBC transducer, and HGB flow cell.
2 ) Sample Rotor Valve (SRV)
Makes volumetric measurement of aspirated blood.
3 ) Rinse Cup
Cleans the sample probe.
4 ) WBC/HGB Lyse (STROMATOLYSER-WH)
Reagent to measure WBC/HGB
5 ) Built-in Printer
Prints analysis data, error messages, etc.
FUNCTIONAL DESCRIPTION
9-32 Sysmex KX-21N Operator’s Manual -- October 1999
8.3 Right Side Panel
2) Power Supply Switch
1) Fuse
3) Power Supply Connector
Figure 9-8-3: Right Side Panel
1 ) Fuse
Replace with provided time-lag type fuse. The rating will be different depending on
the instrument specification.
Specification Part No. Description Fuse Type
117 VAC 266-5109-1 Fuse 250 V 3.15 A ST4-3.15A-N1 Time Lag
220/240 VAC 266-5292-6 Fuse 250 V 2 A No. 19195 Time Lag
• To avoid risk of electrical shock, disconnect the power cord before
replacing the fuses.
• For continued protection against risk of fire, use the fuse of specified
type and rating.
2 ) Power Supply Switch
Turns on and off the main unit power supply.
CAUTION: • Avoid turning this switch ON and OFF continuously in short duration.
This will overload the fuse and may cause fuse blown.
3 ) Power Supply Connector
Using the furnished power supply cord, this connector supplies power from the outlet.
WARNING
CAUTION
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-33
8.4 Left Side Panel
3) 0.0333 MPa Bellows Unit
4) Air filter
2) 0.05 MPa Regulator
1) Trap Chamber
Figure 9-8-4: Left Side Panel
1 ) Trap Chamber
Prevents reagent, etc. from flowing into the vacuum pump of the compressor when an
error occurs with the instrument.
2 ) 0.05 MPa Regulator
Regulates pressure to 0.05 MPa.
3 ) 0.0333 MPa Bellows Unit
Regulates vacuum to 0.0333 MPa vacuum.
4 ) Air Filter
Prevents dirt and dust from entering the bellows.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
FUNCTIONAL DESCRIPTION
9-34 Sysmex KX-21N Operator’s Manual -- October 1999
8.5 Left Side Interior
1) Waste Chamber
2) Pneumatic Unit
Figure 9-8-5: Left Side Interior
1 ) Waste Chamber
Collects wastes from transducers and mixing chambers.
2 ) Pneumatic Unit
Supplies pressure and vacuum.
CAUTION: • Do no open the left face unless your Sysmex service representative
asks you to.
FUNCTIONAL DESCRIPTION
Sysmex KX-21N Operator’s Manual -- October 1999 9-35
8.6 Rear Panel
1) ID Reader Connector
2) GP Connector
3) DP Connector
5) Drain Outlet Nipple
6) Diluent Inlet Nipple
(CELLPACK)
4) Serial Interface
7) Card Slot Protective Cover
Figure 9-8-6: Rear Panel
1 ) ID Reader Connector
Connects an optional hand held barcode reader.
2 ) GP Connector
Connects an optional graphic printer.
3 ) DP Connector
Connects an optional data printer.
4 ) Serial Interface
Connector for communicating with the host computer.
5 ) Drain Outlet Nipple
This nipple drains waste. It connects with the drain sewer or waste tank.
6 ) Diluent Inlet Nipple (CELLPACK)
This nipple aspirates diluent. It connects with the diluent container.
7 ) Card Slot Protective Cover
This is a protective cover for the slot to insert the program card.
Sysmex KX-21N Operator’s Manual -- Revised May 2003
Sysmex KX-21N Operator’s Manual -- October 1999
CHAPTER 10 INSTRUMENT SETUP
1. INTRODUCTION ............................................................... 10-1
2. SYSTEM SETUP................................................................ 10-3
3. DATE/TIME SETTINGS ....................................................... 10-8
4. PATIENT LIMIT ...............................................................10-11
5. QC SETTINGS ................................................................. 10-14
6. HOST SETTINGS..............................................................10-17
7. PRINTER SETTINGS.........................................................10-22
7.1 DP Output Settings.......................................................10-23
7.2 GP/LP Output Settings ..................................................10-25
7.3 IP Output Settings........................................................10-27
8. ID READER SETTINGS ......................................................10-30
9. PASSWORD SETTINGS .....................................................10-32
10. PRINT SET VALUES .........................................................10-35
11. PERIPHERAL SETTINGS ...................................................10-36
12. FACTORY SETTINGS........................................................10-38
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-1
1 . INTRODUCTION
Your Sysmex service representative performs the settings of the instrument at time of
installation. The settings can be changed by using this program.
This chapter describes how to use this setting program.
System Setup
Sets up the instrument system status.
Date/Time
Sets date/time of the built-in clock.
Patient Limit
Sets upper and lower Patient Mark Limits to check for error in analysis data.
QC Settings
Selects between X control and L-J control as the QC method, and sets the output method of
QC data.
Host Settings
Sets the interface conditions for transferring data to the host computer.
Printer Settings
Sets the output selection and output conditions of the built-in printer or the external printers
(Data Printer, Graphic Printer: option).
ID Reader Settings
Sets whether to Use or Not Use of the hand held barcode reader (option).
Password Settings
Sets and changes the password.
Print Set Values
Prints all the contents of the settings by the built-in printer.
Peripheral Setting
Sets whether to Use or Not Use of the printer, hand held barcode reader (option), or the host
computer output.
CAUTION: • The setting program can be run only when the instrument is ready.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTRUMENT SETUP
10-2 Sysmex KX-21N Operator’s Manual -- October 1999
NOTE: • Menu selection method
(1) Cursor selection (explained in this Manual)
Using [ ] or [ ] key, move the cursor to a desired program and
press [ENTER] key to set.
(2) Direct key selection
Using the numeric keys, enter a menu number of the program you
want to set, thus selecting the menu.
The menu number is displayed on the Menu screen.
• Change set values and move the cursor to the next parameter using
[ ] or [ ] key ([ ] or [ ] key also can be used in Patient Limit setting)
or press [ENTER] key. This sets the settings.
• When the password is set, the following programs cannot be used if
the password is not input.
• System Setup
• Patient Limit
• QC Settings
• Password Settings
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-3
2 . SYSTEM SETUP
This program is used to set unit system, display language, and WBC analysis parameters.
How to Setup System Status
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "6: Settings."
(3) Press [ENTER] key. The Setting Menu screen appears.
*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
Figure 10-2-1: Setting Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "1: System Setup."
INSTRUMENT SETUP
10-4 Sysmex KX-21N Operator’s Manual -- October 1999
(5) Press [ENTER] key. The current setting status is displayed on the System Setup
screen.
Units Type2
Parameter Naming LYM%
Language English
*System Setup*
Press [SELECT] to exit.
Figure 10-2-2: System Setup Screen
NOTE: • When the password is set, the Password Input screen appears, and
input the password, and then press [ENTER] key
(6) Using [ ] or [ ] key, move the cursor to select the desired set parameter.
For System Setup, three parameters can be set.
(7) Using [ ] or [ ] key, select the content of settings. Each time you press the key, the
content of settings changes.
(8) Press [ENTER] key. The content of settings is set and the cursor moves to the next set
parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1 ) Unit Setting
Sets the unit system for displaying analysis data. The unit can be selected from
the following six kinds:
Settings Unit System Settings Unit System
Type 1 For Japan Type 4 Dutch SI
Type 2 For General Export Type 5 Standard SI
Type 3 Canada SI Type 6 Hong Kong SI
Table 10-2-1: Unit Setting
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 10-5
For the detail of unit system, refer to the following table:
For Japan For General Export Canada SI
Item Decimal
point
Unit Decimal
point
Unit Decimal
point
Unit
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
RDW-SD
RDW-CV
MPV
####
####
###.#
###.#
###.#
###.#
###.#
###.#
###.#
###.#
###.#
####
####
####
###.#
###.#
###.#
×102
/µL
×104
/µL
g/dL
%
fL
pg
g/dL
×104
/µL
%
%
%
×102
/µL
×102
/µL
×102
/µL
fL
%
fL
###.#
##.##
###.#
###.#
###.#
###.#
###.#
####
###.#
###.#
###.#
###.#
###.#
###.#
###.#
###.#
###.#
×103
/µL
×106
/µL
g/dL
%
fL
pg
g/dL
×103
/µL
%
%
%
×103
/µL
×103
/µL
×103
/µL
fL
%
fL
###.#
##.##
####
#.###
###.#
###.#
####
####
#.###
#.###
#.###
###.#
###.#
###.#
###.#
#.###
###.#
×109
/L
×1012
/L
g/L
L/L
fL
pg
g/L
×109
/L
×109
/L
×109
/L
×109
/L
fL
fL
Dutch SI Standard SI Hong Kong SI
Item Decimal
point
Unit Decimal
point
Unit Decimal
point
Unit
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
RDW-SD
RDW-CV
MPV
###.#
##.##
###.#
#.###
###.#
####
###.#
####
#.###
#.###
#.###
###.#
###.#
###.#
###.#
#.###
###.#
×109
/L
×1012
/L
mmol/L
L/L
fL
amol
mmol/L
×109
/L
×109
/L
×109
/L
×109
/L
fL
fL
###.#
##.##
####
#.###
###.#
###.#
####
####
#.###
#.###
#.###
###.#
###.#
###.#
###.#
#.###
###.#
×109
/L
×1012
/L
g/L
fL
pg
g/L
×109
/L
×109
/L
×109
/L
×109
/L
fL
fL
###.#
##.##
###.#
#.###
###.#
###.#
###.#
####
###.#
###.#
###.#
###.#
###.#
###.#
###.#
###.#
###.#
×109
/L
×1012
/L
g/dL
fL
pg
g/dL
×109
/L
%
%
%
×109
/L
×109
/L
×109
/L
fL
%
fL
Table 10-2-2: Details of Unit System
Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
INSTRUMENT SETUP
10-6 Sysmex KX-21N Operator’s Manual -- October 1999
2 ) Language Setting
Set the language for displaying on the screen. The language can be selected from
the eight kinds listed below:
Settings Display language
Japanese Japanese
English English
Chinese Chinese
French French
German German
Spanish Spanish
Italian Italian
Portuguese Portuguese
Table 10-2-3: Language Setting
3 ) Parameter Name Setting
Set WBC analysis parameter names. The parameter can be selected from the
following two kinds:
Settings Analysis Parameter Name
W-SCR W-SCR
W-MCR
W-LCR
W-SCC
W-MCC
W-LCC
LYM% LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Table 10-2-4: Parameter Name Setting
NOTE: • The settings of language become valid from the next time you turn ON
the instrument power.
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-7
(9) When the setting of each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
Change? Cont. Set Cancel
Figure 10-2-3: Setting Change Confirmation Message
(10) Using[ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the System Setup screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(11) Press [ENTER] to execute the selected process.
INSTRUMENT SETUP
10-8 Sysmex KX-21N Operator’s Manual -- October 1999
3 . DATE/TIME SETTINGS
This instrument displays date/time on analysis data, using the built-in clock.
This program is used to set the date/time for the built-in clock and date format.
How to Set Date/Time
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "6: Settings."
(3) Press [ENTER] key. The Setting Menu screen appears.
*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
Figure 10-3-1: Setting Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "2: Date/Time."
(5) Press [ENTER] key. The current setting status is displayed on the Date/Time screen.
Date Format dd/mm/yyyy
dd 31
mm 12
yy 1999
mm 59
hh 23
*Date/Time*
Press [SELECT] to exit.
Figure 10-3-2: Date/Time Screen
(6) Using [ ] or [ ] key, move the cursor to select the desired set parameter.
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-9
(7) Using [ ], [ ], or the numeric keys, set each parameter.
In setting the date format, use [ ] or [ ] key. Year, month, day, hour, and minute
are entered using the numeric keys.
(8) Press [ENTER] key. The content of the settings is set and the cursor moves to the
next set parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1 ) Date Format Setting
Using [ ] or [ ] key, select the date format.
The date format can be selected from the following three types. It changes each
time you press the key.
Settings Example of display
yyyy/mm/dd 1999/12/31
mm/dd/yyyy 12/31/1999
dd/mm/yyyy 31/12/1999
Table 10-3-1: Date Format Setting
2 ) Year Setting
Enter in the dominical year using the numeric keys.
3 ) Month Setting
Enter the numerical value of 1 - 12 using the numeric keys.
4 ) Day Setting
Enter the numerical value of 1 - 31 using the numeric keys.
5 ) Hour Setting
Enter the numerical value of 0 - 23 by 24-hour system with using the numeric
keys
6 ) Minute Setting
Enter the numerical value of 0 - 59 using the numeric keys
INSTRUMENT SETUP
10-10 Sysmex KX-21N Operator’s Manual -- October 1999
(9) When the setting of each parameter is completed, press [SELECT] key.
The date entered is checked and when there is no setting error, the Setting Change
Confirmation message is displayed.
If there is any setting error, the alarm sounds and the Setting Change Confirmation
message is not displayed.
NOTE: • About the date setting, the following items are checked:
Leap year check: whether 2/29 is set in non-leap year
Month/day check: whether 4/31, e.g., is set
Change? Cont. Set Cancel
Figure 10-3-3: Setting Change Confirmation Message
(10) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Date/Time screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(11) Press [ENTER] key to execute the selected process.
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-11
4 . PATIENT LIMIT
For Patient Limit, you can set Mark Limits.
The Mark Limits are the values set to determine whether analysis values are within the
normal range or not. This program can be used to set the upper and lower Mark Limits for
each analysis parameter.
When analysis data exceeds the upper Mark Limit, it is flagged with [+] mark, and when it
exceeds the lower Mark Limit, it is flagged with [-] mark. Analysis data output to the built-in
printer or the host computer is also attached with either marks.
How to Set Mark Limits
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "6: Settings."
(3) Press [ENTER] key. The Setting Menu screen appears.
*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
Figure 10-4-1: Setting Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "3: Patient Limit."
INSTRUMENT SETUP
10-12 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
(5) Press [ENTER] key. The current setting status is displayed on the Patient Limit
screen.
LL UL
HGB 8.0 17.0 g/dL
RBC 2.50 5.50 ×106
/µL
WBC 3.0 15.0 ×103
/µL
MCV 86.0 110.0 fL
HCT 26.0 50.0 %
MCH 26.0 38.0 pg
PLT 50 400 ×103
/µL
MCHC 31.0 37.0 g/dL
LYM% 5.0 55.0 %
MXD% 1.0 20.0 %
*Patient Limit*
Press [SELECT] to exit.
Figure 10-4-2: Patient Limit Screen
NOTE: • When the password is set, the Password Input screen appears, and
input the password, and then press [ENTER] key
(6) Using [ ] or [ ] key, move the cursor to select the desired set parameter.
NOTE: • Total 17 setting parameters of Patient Limit are displayed. But not all of
them can be displayed in one screen at a time. Therefore, scroll the
screen using [ ] or [ ] key.
LL UL
LYM# 0 0 ×103
/µL
NEUT% 45.0 95.0 %
MXD% 1.0 20.0 %
NEUT# 0 0 ×103
/µL
MXD# 0 0 ×103
/µL
RDW-SD 37.0 54.0 fL
PDW 9.0 17.0 %
RDW-CV 11.0 16.0 %
MPV 9.0 13.0 fL
P-LCR 13.0 43.0 %
*Patient Limit*
Press [SELECT] to exit.
Figure 10-4-3: Scrolling the Screen
(7) Using [ ] or [ ] key, move the cursor to select LL (Lower Limit) or UL (Upper
Limit).
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-13
(8) Enter the settings using the numeric keys.
(9) Press [ENTER] key. The content of settings is set and the cursor moves to the next set
parameter.
NOTE: • When [ ], [ ], [ ], or [ ] key is pressed after entering, the contents
of settings are also set.
• When both the upper and lower limits are set at "0," the judgment on
patient limit is not executed.
(10) When the setting of each parameter is completed, press [SELECT] key.
When the set values are checked and there is no setting error, the Setting Change
Confirmation message is displayed.
In case Upper Limit < Lower Limit is set, the alarm sounds and the Setting Change
Confirmation message is not displayed.
Change? Cont. Set Cancel
Figure 10-4-4: Setting Change Confirmation Message
(11) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Patient Limit screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(12) Press [ENTER] key to execute the selected process.
INSTRUMENT SETUP
10-14 Sysmex KX-21N Operator’s Manual -- October 1999
5 . QC SETTINGS
This program is used to set QC method and output method of QC data. Two kinds of QC
methods are available with this instrument: X control and L-J control. Select either of them
that suits your purpose.
X Control: Control blood is subjected to two consecutive analyses and the mean of
them is used as the QC data. This method causes little influence on
reproducibility in analysis.
L-J Control: This control uses the data from a single analysis of control blood as QC
data. The control width in the L-J control is prone to influence in
reproducibility in analysis, so that the control width is wider than in the
case of X control.
How to Set QC Settings
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "6: Settings."
(3) Press [ENTER] key. The Setting Menu screen appears.
*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
Figure 10-5-1: Setting Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "4: QC Settings."
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-15
(5) Press [ENTER] key. The current setting status is displayed on the QC Settings screen.
Data Output Print
*QC Settings*
Press [SELECT] to exit.
QC Method X
Figure 10-5-2: QC Settings Screen
NOTE: • When the password is set, the Password Input screen appears, and
input the password, and then press [ENTER] key
(6) Using [ ] or [ ] key, move the cursor to select the set parameter. QC settings can be
made on three parameters.
(7) Using [ ] or [ ] key, select the content of settings.
The content of settings changes each time you press the key.
(8) Press [ENTER] key. The content of setting is set and the cursor moves to the next
analysis parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1 ) QC Method Setting
Set the QC method. The QC method can be selected from the following two
kinds: 17
Settings QC Method
X X Control
L-J L-J Control
Table 10-5-1: QC Method Setting
INSTRUMENT SETUP
10-16 Sysmex KX-21N Operator’s Manual -- October 1999
2 ) Data Output Setting
Set the QC data output method. The QC data output can be selected from the
following four kinds:
Settings QC data output
None Not output
Print Print on built-in printer
Host Output to host computer
Print, Host Print on built-in printer and output to host computer
Table 10-5-2: Data Output Setting
NOTE: • For print format to the built-in printer, refer to Chapter 5, Section 2.6:
Execute X Control or Chapter 5, Section 2.7: Execute L-J Control.
• For output format to the host computer, refer to Appendix B: Technical
Information.
• The data output format for quality control differs from the format for usual
analysis.
(9) When the setting for each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
Change? Cont. Set Cancel
Figure 10-5-3: Setting Change Confirmation Message
(10) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the QC Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(11) Press [ENTER] key to execute the selected process.
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-17
6 . HOST SETTINGS
This program is used to set the interface conditions for transferring data to the host computer.
How to Set Host Output
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "6: Settings."
(3) Press [ENTER] key. The Setting Menu screen appears.
*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
Figure 10-6-1: Setting Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "5: Host Settings."
(5) Press [ENTER] key. The current setting status is displayed on the Host Settings
screen.
Auto Output On
Output Format K-1000
Data Length 7bits
Baud Rate 2400
Stop Bit 2bits
Protocol Class A
Interval 2
RTS/CTS Ignore
Parity Check Even
*Host Settings*
Press [SELECT] to exit.
Connect Not Use
Figure 10-6-2: Host Settings Screen
INSTRUMENT SETUP
10-18 Sysmex KX-21N Operator’s Manual -- October 1999
(6) Using [ ] or [ ] key, move the cursor to select the desired set parameter. For Host
Settings, twelve parameters can be set.
NOTE: • There are 12 setting parameters for Host Settings, but all the setting
parameters cannot be listed in one screen, so scroll the screen with [ ]
key or [ ] key.
RDW Output RDW-CV
ID Padding 0 Padding
*Host Settings*
Press [SELECT] to exit.
Figure 10-6-3: Host Settings Screen
(7) Using [ ] or [ ] key, select the condition. The condition changes each time you
press the key.
(8) Press [ENTER] key. The content of settings is set and the cursor moves to the next set
parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1 ) Connect Settings
Set whether to connect the host computer or not.
Settings Connection
Use Connect
Not Use Not Connect
Table 10-6-1: Host Output Settings
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-19
2 ) Output Format Settings
Set output format of analysis data to the host computer. This can be selected
from the following three kinds:
Settings Output Format
KX-21N Standard output format of KX-21N
Refer to Appendix B: Technical Information.
K-1000 ASCII data is output in the published format.
Refer to Appendix B: Technical Information.
K-DPS Binary data is output for connecting with K-DPS.
Data format is not published.
Table 10-6-2: Output Format Settings
3 ) Auto Output Settings
Set whether to make auto output to the host computer or not.
Settings Auto Output
On Auto Output
Off Not Auto Output
Table 10-6-3: Auto Output Settings
4 ) Baud Rate Settings
Set the baud rate. This can be selected from the following four kinds:
Settings Baud Rate
1200 1200 bps
2400 2400 bps
4800 4800 bps
9600 9600 bps
Table 10-6-4: Baud Rate Settings
5 ) Data Length Settings
Set the data length. This can be selected from the following two kinds:
Settings Data Length
7 bits 7 bits
8 bits 8 bits
Table 10-6-5: Data Length Settings
INSTRUMENT SETUP
10-20 Sysmex KX-21N Operator’s Manual -- October 1999
6 ) Stop Bit Settings
Set the stop bit. This can be set selected from the following two kinds:
Settings Stop Bit
1 bit 1 bit
2 bits 2 bits
Table 10-6-6: Stop Bit Settings
7 ) Parity Check Settings
Set the parity check method. This can be set selected from the following three
kinds:
Settings Parity Check
None None
Odd Odd
Even Even
Table 10-6-7: Parity Check Settings
8 ) Protocol Settings
Set the protocol. This can be set selected from the following two kinds:
Settings Protocol
Class A Class A
Class B Class B
Table 10-6-8: Protocol Settings
9 ) Transmission interval Settings
Select a transmission interval from the following:
Settings Interval
0 0 second
2 2 seconds
3 3 seconds
5 5 seconds
7 7 seconds
10 10 seconds
15 15 seconds
Table 10-6-9: Transmission Interval
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-21
10) RTS/CTS control Settings
Specify whether or not the RTS/CTS flow control takes place.
Settings RTS/CTS control
Refer Allowed
Ignore Not allowed
Table 10-6-10: RTS/CTS control
11) RDW Output
When the K-1000 format is selected, RDW Output can be set by selecting from
following two types.
Settings RDW Output
RDW-SD Outputs RDW-SD
RDW-CV Outputs RDW-CV
Table 10-6-11: RDW Output
12) ID Padding
The sample ID can be set whether to make padding by selecting from following
two types.
Settings Padding
0 Padding Allowed 0 padding
None Not allowed 0 padding
Table 10-6-12: ID Padding
NOTE: • ID Padding will set how to pad the most significant digits output to the
host computer, if the number of the sample ID digits is 14 or less.
ex) When the Sample ID No. is “12345”
0 Padding “000000000012345”
None “∆∆∆∆∆∆∆∆∆∆12345” “∆” means “a space”.
(9) When the setting of each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
Change? Cont. Set Cancel
Figure 10-6-4: Setting Change Confirmation Message
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTRUMENT SETUP
10-22 Sysmex KX-21N Operator’s Manual -- October 1999
(10) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Host Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(11) Press [ENTER] key to execute the selected process.
7 . PRINTER SETTINGS
This program is used to set the output selection and output conditions for the built-in printer
or the external printers (Data Printer, Graphic Printer).
How to Set Printer Output
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "6: Settings."
(3) Press [ENTER] key. The Setting Menu screen appears.
*Settings*
1:System Setup1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
Figure 10-7-1: Setting Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "6: Printer Settings."
(5) Press [ENTER] key. The Printer Settings Menu screen appears.
1 :1 : DP
2 : GP/LP
3 : IP
*Settings*
Figure 10-7-2: Printer Settings Menu Screen
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-23
NOTE: • When you press [ENTER] key on this screen, the screen returns to the
Analysis screen.
(6) Using [ ] or [ ] key, move the cursor and select the printer to be set.
(7) Press [ENTER] key.
The Printer Settings screen for the selected printer appears.
For how to set the printer output of DP (Data Printer), refer to Section 7.1: DP Output
Settings in this chapter.
For how to set the printer output of GP/LP (Graphic Printer), refer to Section 7.2:
GP/LP Output Settings in this chapter.
For how to set the printer output of IP (Built-in Printer), refer to Section 7.3: IP
Output Settings in this chapter.
7.1 DP Output Settings
Select "1: DP" on Printer Settings Menu screen and press [ENTER] key. The DP Settings
screen for Data Printer appears.
DP Auto Output On
*DP*
Press [SELECT] to exit.
ConnectConnect Use
Figure 10-7-3: DP Settings Screen
(1) Using [[ ] or [ ] key, move the cursor to select the desired setting parameter.
In the output setting for the data printer, you can set two parameters.
(2) Using [ ] or [ ] key, select the content of settings.
The content of settings changes each time you press the key.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTRUMENT SETUP
10-24 Sysmex KX-21N Operator’s Manual -- October 1999
(3) Press [ENTER] key. The content of setting is set and the cursor moves to the next
analysis parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1 ) Connect Settings
Set whether to use the data printer or not.
Settings Connection
Use Connect
Not Use Not Connect
Table 10-7-1: Data Printer Settings
2 ) DP Auto Output Settings
Whether the analysis data is output to the data printer by the automatic operation
can be set.
Settings Auto Output
On Auto Output
Off Not Auto Output
Table 10-7-2: Auto Output Settings
(4) When the setting of each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
Change? Cont. Set Cancel
Figure 10-7-4: Setting Change Confirmation Message
(5) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the DP Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(6) Press [ENTER] key to execute the selected process.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-25
7.2 GP/LP Output Settings
Select "2: GP/LP" on Printer Settings Menu screen and press [ENTER] key. The GP/LP
Settings screen for Graphics Printer appears.
Printer type Type1
*GP/LP*
Press [SELECT] to exit.
Connect Use
GP Auto Output On
Figure 10-7-5: GP/LP Settings Screen
(1) Using [[ ] or [ ] key, move the cursor to select the desired setting parameter.
In the output setting for the data printer, you can set three parameters.
(2) Using [ ] or [ ] key, select the condition.
The condition changes each time you press the key.
(3) Press [ENTER] key. The content of setting is set and the cursor moves to the next
analysis parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1 ) Connect Settings
Set whether to use the graphic printer or not.
Settings Connection
Use Connect
Not Use Not Connect
Table 10-7-3: Graphic Printer Settings
INSTRUMENT SETUP
10-26 Sysmex KX-21N Operator’s Manual -- October 1999
2 ) Printer type Settings
The type of graphic printer to be connected can be set by selecting from
following two types.
Settings Printer type
Type 1 Printer of ESC/P system
Type 2 Printer of PCL5 system
Table 10-7-4: Printer type Settings
3 ) GP Auto Output Settings
Whether the analysis data is output to the graphic printer by the automatic
operation can be set.
Settings Auto Output
On Auto Output
Off Not Auto Output
Table 10-7-5: Auto Output Settings
(4) When the setting of each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
Change? Cont. Set Cancel
Figure 10-7-6: Setting Change Confirmation Message
(5) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the GP/LP Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(6) Press [ENTER] key to execute the selected process.
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-27
7.3 IP Output Settings
Select "3: IP" on Printer Settings Menu screen and press [ENTER] key. The IP Settings
screen for Built-in Printer appears.
Print Format Type1
Press [SELECT] to exit.
*IP*
Print Condition All Data
Connect Use
Figure 10-7-7: IP Settings Screen
(1) Using [ ] or [ ] key, move the cursor to select the set parameter. Printer settings can
be made on three parameters.
(2) Using [ ] or [ ] key, select the condition.
The condition changes each time you press the key.
(3) Press [ENTER] key. The content of settings is set and the cursor moves to the next set
parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1 ) Connect Settings
Set whether to use the built-in printer or not.
Settings Connection
Use Connect
Not Use Not Connect
Table 10-7-6: Built-in Printer Settings
INSTRUMENT SETUP
10-28 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
2 ) Print Condition Settings
Set the auto print condition for the built-in printer. This can be selected from the
following three kinds:
Settings Auto Print Conditions
All Data Print All Samples
Abnormal Data Print Abnormal Data Only
None Not Auto Print
Table 10-7-7: Print Condition Settings
NOTE: • Data printed as abnormal data:
• Data in which analysis error occurred
• Data in which noise error occurred
• Data with flags other than Mark Limits
• Data with histogram flag
• Data out of the linearity limit
• For print conditions of QC data, refer to Chapter 10, Section 5: QC
Settings.
3 ) Print Format Settings
Set the print format for the built-in printer. This can be selected from the
following three kinds:
Settings Print Format
Type 1 Print 17 parameters + histograms.
Type 2 Print 17 parameters.
Type 3 Print 8 parameters.
Table 10-7-8: Print Format Settings
NOTE: • For print format, refer to Chapter 2, Section 5.2 Printing of Analysis
Result.
• For print format for quality control, refer to Chapter 5, Section 2.6:
Execute X Control or Chapter 5, Section 2.7: Execute L-J Control.
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-29
(4) When the setting of each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
Change? Cont. Set Cancel
Figure 10-7-8: Setting Change Confirmation Message
(5) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Printer Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(6) Press [ENTER] key to execute the selected process.
INSTRUMENT SETUP
10-30 Sysmex KX-21N Operator’s Manual -- October 1999
8 . ID READER SETTINGS
This program can set whether to Use or Not Use of the hand held barcode reader (option)
which is for reading the sample IDs.
How to Set ID Reader
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "6: Settings."
(3) Press [ENTER] key. The Setting Menu screen appears.
*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
Figure 10-8-1: Setting Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "7: ID Reader Settings."
(5) Press [ENTER] key. The current setting status appears on ID Reader Settings screen.
Press [SELECT] to exit.
*IP Reader*
Connect Use
Figure 10-8-2: ID Reader Settings Screen
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-31
(6) Using [ ] or [ ] key, select "Use" or "Not Use."
The display of "Use" and "Not Use" changes whenever the key is pressed.
(7) Press [ENTER] key. The setting contents can be confirmed.
(8) Press [SELECT] key. The Setting Change Confirmation message appears.
Change? Cont. Set Cancel
Figure 10-8-3: Setting Change Confirmation Message
(9) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Printer Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(10) Press [ENTER] key to execute the selected process.
INSTRUMENT SETUP
10-32 Sysmex KX-21N Operator’s Manual -- October 1999
9 . PASSWORD SETTINGS
This program can set and change the password.
NOTE: • In order to execute under the control of the instrument manager, an
important program is protected by the password.
• For the programs protected by the password, refer to Chapter 1,
Section 14: MENU TREE.
• When the program protected by the password is executed, the
Password Input window appears. When the set password is input,
and [ENTER] key is pressed, the program is executed.
How to Set Password
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "6: Settings."
(3) Press [ENTER] key. The Setting Menu screen appears.
*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
Figure 10-9-1: Setting Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "8: Password Settings."
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-33
(5) Press [ENTER] key. The Password Settings screen appears.
New Password [ ]
Enter Again [ ]
Press [SELECT] to exit.
*Password*
Figure 10-9-2: Password Settings Screen
NOTE: • When you have already set the password, the Password Input screen
is displayed, and then input a correct password.
Password [ ]
Press [SELECT] to exit.
*Password*
Figure 10-9-3: Password Input Screen
In the input of a correct password, and pressing [ENTER] key, the
Password Settings screen appears.
• On the screen, all the values of the password display part are
displayed by "*". The purpose of this is to make other people not
seen the password when setting it.
• Press [SELECT] key to discontinue the password setting, and to return
to Analysis screen.
INSTRUMENT SETUP
10-34 Sysmex KX-21N Operator’s Manual -- October 1999
(6) Input the set password to the New Password column with numeric keys, and press
[ENTER] key.
Set the password up to 10 digits by using the figure (0-9) or the hyphen (-).
If [ENTER] key is pressed, the status becomes the input waiting for the Enter Again
column.
NOTE: • When you do not set the password, the password can be deleted by
the following operating.
• Press [ENTER] key at the status of no password input.
(7) Again, input the set password to the Enter Again column with numeric keys, and press
[ENTER] key.
If the password input to the New Password column and the password input to the
Enter Again are different, set over again from the input of the New Password column.
If they are the same, the Setting Change Confirmation message appears.
Change? Cont. Set Cancel
Figure 10-9-4: Setting Change Confirmation Message
(8) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Printer Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(9) Press [ENTER] key. The Setting Menu screen appears.
NOTE: • When the password has been forgotten, contact Sysmex service
representative.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-35
10. PRINT SET VALUES
To backup the set values, all the contents of the settings can be printed by the built-in printer.
How to Print Set Values
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "6: Settings."
(3) Press [ENTER] key. The Setting Menu screen appears.
*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
Figure 10-10-1: Setting Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select "9: Print Set Values."
(5) Press [ENTER] key. The built-in printer starts printing all the set values.
NOTE: • If any faulty operation occurs, contact your Sysmex service
representative. Keep the printed contents of the settings in good
condition because the service representative may have to confirm the
contents of settings.
• When the QC method of the QC Setting is “X”, it is printed as “X”.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTRUMENT SETUP
10-36 Sysmex KX-21N Operator’s Manual -- October 1999
11. PERIPHERAL SETTINGS
When you want to temporarily cancel external output due to error occurrence, use this
program to set "Use" or "Not use" of the built-in/external printer, host computer output or
the hand held barcode reader.
NOTE: • For peripheral settings, refer to "5: "Host Settings" and "6: Printer
Settings" which carry description of similar settings.
How to Set Peripheral Connection
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
*SELECT*
1:Stored Data
2:Quality Control
3:Calibration
4:Replace Lyse
5:Auto Rinse
6:Settings
7:Maintenance
8:Periph. Settings
00:PU Sleep
Figure 10-11-1: Select Menu Screen
(2) Using [ ] or [ ] key, move the cursor to select "8: Periph. Settings."
(3) Press [ENTER] key. This displays connection status of external devices on the
Peripheral Settings screen.
*Periph.Settings*
DP Use
Host Output Use
ID Reader Use
Press [SELECT] to exit.
IP Use
GP/ LP Use
(Data Printer)
(Graphic Printer)
(Built-in Printer)
Figure 10-11-2: Peripheral Settings Screen
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-37
(4) Using [ ] or [ ] key, move the cursor to select the desired external device.
(5) Using [ ] or [ ] key, select "Use" or "Not Use". "Use" and "Not Use" change over
each time you press the key.
(6) Press [ENTER] key. The content of the settings is set and moves the cursor to the
next set parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
(7) Press [SELECT] key. The Setting Change Confirmation message appears.
Change? Cont. Set Cancel
Figure 10-11-3: Setting Change Confirmation Message
(8) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Peripheral Settings screen. And the setting operation can
be continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(9) Press [ENTER] key to execute the selected process.
INSTRUMENT SETUP
10-38 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
12. FACTORY SETTINGS
The settings made at the factory are listed below:
• System Settings
Units Type 2
Language English
Parameter Naming LYM%
• Date/Time
Date Format dd/mm/yyyy
• Patient Limits LL UL
WBC 3.0 15.0
RBC 2.50 5.50
HGB 8.0 17.0
HCT 26.0 50.0
MCV 86.0 110.0
MCH 26.0 38.0
MCHC 31.0 37.0
PLT 50 400
LYM% 5.0 55.0
MXD% 1.0 20.0
NEUT% 45.0 95.0
LYM# 0.0 0.0
MXD# 0.0 0.0
NEUT# 0.0 0.0
RDW-SD 37.0 54.0
RDW-CV 11.0 16.0
MPV 9.0 13.0
• QC Settings
QC Method L-J
Data Output Print
• Host Settings
Connect Not use
Output format KX-21N
Auto Output Off
Baud Rate 2400 bps
Data Length 7 bits
Stop Bit 2 bits
Parity Check Even
Protocol Class A
Interval 2
RTS/CTS Ignore
RDW Output RDW-CV
ID Padding 0 Padding
Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.
INSTRUMENT SETUP
Sysmex KX-21N Operator’s Manual -- October 1999 10-39
• Printer Settings (DP)
Connect Not use
DP Auto Output Off
• Printer Settings (GP/LP)
Connect Not use
Printer type Type 1
GP Auto Output Off
• Printer Settings (IP)
Connect Use
Print Condition All Data
Print Format Type 1
• ID Reader
Connect Not Use
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTALLATION
APPENDIX A: INSTALLATION
1. INTRODUCTION ........................................................................A-1
2. CHECK BEFORE INSTALLATION ..................................................A-2
3. INSTALLATION SPACE ...............................................................A-3
4. REMOVE SHIPPING CLAMPS .......................................................A-4
5. CONNECT TUBE ........................................................................A-6
5.1 Prepare Reagent ....................................................................A-6
5.2 Connect CELLPACK..............................................................A-6
5.3 Connect STROMATOLYSER-WH..............................................A-8
5.4 Connect Waste Line................................................................A-9
6. SET PRINTER PAPER ................................................................ A-10
7. CONNECT POWER CORD AND CONNECTING CABLES.................... A-12
7.1 Connect Host Computer, Printer, and Hand Held Barcode Reader........ A-12
7.2 Connect Power Cord ............................................................ A-12
8. TURN POWER ON .................................................................... A-13
9. REINSTALLING THE PROGRAM ................................................. A-13
INSTALLATION
Sysmex KX-21N Operator’s Manual -- October 1999 A-1
1 . INTRODUCTION
This product is a clinical test instrument. Sysmex representative is responsible for
unpacking, installing, and initial setup of the product to ensure its proper and safe operation.
The next several pages will give some essential information on this instrument.
NOTE: • When the optional external printers (Data Printer and Graphic Printer) or
Hand Held Barcode Reader is intended to incorporate to this instrument,
contact your Sysmex service representative.
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTALLATION
A-2 Sysmex KX-21N Operator’s Manual -- October 1999
2 . CHECK BEFORE INSTALLATION
Make sure the KX-21N is free from external damages and check the quantities of the
provided supply parts.
Quantity
No. Part No. Description 117 V 220 V 240 V
1
1
2
2
2
3
4
5
6
7
8
9
10
10
11
12
13
14
461-2264-1
461-2265-5
923-8092-8
265-4731-5
265-4728-3
943-1781-1
973-3041-7
367-1051-9
442-5338-7
442-5340-5
423-1776-2
933-3601-9
266-5109-1
266-5292-6
266-6743-4
369-8234-6
462-4842-7
993-2811-6
OPERATOR'S MANUAL KX-21N (N.A.)
OPERATOR'S MANUAL KX-21N (ENGLISH)
POWER CORD NO. 15 (C-2/N. AMERICA)
POWER CORD 4622-007-0092 (EUROPE)
POWER CORD NO. 7650
CUBITAINER SPOUT KIT NO. 1 (20 L)
FLOAT SWITCH NO. 23 ASSY
TRAY NO. 20
TUBE POLYURETHANE 4 MM ID × 6 MM OD
TUBE POLYURETHANE 6 MM ID × 9 MM OD
MINI-PET NO. 10 (1 ML)
TRANSDUCER BRUSH NO. 1
FUSE 250V 3.15A ST4-3.15A-N1
FUSE 250V 2A NO. 19195 (EUROPE)
CLAMP LWS-8S-2.5W
CAUTION MARK NO.170
PAPER THERMAL F1-2 (5/BOX)
PROGRAM CARD 1KXNH ASSY
1
0
1
-
-
1
1
1
3 M
6 M
2
1
2
-
1
1
1
1
0
1
-
1
-
1
1
1
3 M
6 M
2
1
-
2
1
1
1
1
0
1
-
-
1
1
1
1
3 M
6 M
2
1
-
2
1
1
1
1
Table A-2-1: KX-21N Unpacking Checklist
NOTE: • Item No. 4 (973-3041-7 Float Switch No. 23 Assy) is pre-installed in
the Main Unit Front Interior at the factory.
• Affix the Caution Mark No.170 to some place on the front panel that is
easily visible.
• If you need to order supplies or replacement parts, please contact your
local Sysmex representative.
Sysmex KX-21N Operator’s Manual -- Revised August 2001
INSTALLATION
Sysmex KX-21N Operator’s Manual -- October 1999 A-3
3 . INSTALLATION SPACE
To ensure that the instrument performs to its full extent, it should be installed at an
appropriate place.
• Select a place where the power supply is located close.
• Secure a space for maintenance and service. Giving consideration to heat radiation by the
instrument, provide at least 50 cm clearance between the wall and the instrument's side
rear, and top panels. You may need some more desktop space if optional Data Printer and
Graphic Printer are provided.
Each dimension of the instrument is shown below. The power cord is 1.8 m long.
Width (mm) Depth (mm) Height (mm) Weight (kg)
Main Unit 420 355 480 30
Table A-3-1: Instrument Dimensions
480
355
420
Figure A-3-1: Instrument Dimensions
INSTALLATION
A-4 Sysmex KX-21N Operator’s Manual -- Revised May 2002 N.A.
4 . REMOVE SHIPPING CLAMPS
(1) Peel off the fixing tape of the outer cover gently.
Figure A-4-1: Removing the Tape
(2) Open the front cover of the main unit.
(3) Remove the protection sheets of the sampling valve.
1) Remove the SRV fixing screw.
2) With the fixed and rotary valves separated sufficiently, remove the protection
sheets.
3) Return the valves and the SRV fixing screw to their original positions.
4) Set the provided sample rotor valve tray.
Protection Sheets
SRV Fixing Screw
Tray No. 20
Figure A-4-2: Removing the Protection Sheets
INSTALLATION
Sysmex KX-21N Operator’s Manual -- October 1999 A-5
(4) Remove the pneumatic unit fixing screws (2 pcs). Keep these screws for future use.
Fixing Screws
Figure A-4-3: Removing the Screws
(5) Remove the rubber caps of the reagent connection nipples. Keep these rubber caps for
future use.
Rubber Caps
Figure A-4-4: Removing the Rubber Caps
Sysmex KX-21N Operator’s Manual -- Revised May 2003
INSTALLATION
A-6 Sysmex KX-21N Operator’s Manual -- October 1999
5 . CONNECT TUBE
5.1 Prepare Reagent
Prepare the reagents and connection kits shown below.
Reagent Part No. Type Part Name Connection Kit
884-0871-1 PK-30L CELLPACK Cubitainer spout kit No. 1 (for 20L)
974-0521-6 SWH-200A STROMATOLYSER-WH Float switch No. 23
5.2 Connect CELLPACK
(1) Prepare the following reagent tube.
Tube Polyurethane 4 mmID × 6 mmOD : 1 pc
NOTE: • Cut the tube to an appropriate length, and connect it.
(2) Connect the diluent (CELLPACK) inlet aspiration nipple behind the unit and the nipple
of the cubitainer spout kit No. 1 with the tube polyurethane 4 mmID × 6 mmOD.
(3) Set the cubitainer spout kit No. 1 to the CELLPACK container.
CELLPACK
Cap
Cubitainer Spout Kit No. 1
Figure A-5-1: Setting the Cubitainer Spout Kit
INSTALLATION
Sysmex KX-21N Operator’s Manual -- October 1999 A-7
Tube Polyurethane 4 mmID × 6 mmOD
Diluent Inlet Nipple
Cubitainer Spout Kit No. 1
CELLPACK
Figure A-5-2: Connecting the CELLPACK
• Take care not to spill a reagent on to the instrument. If it spills, wipe it
off immediately using a wet cloth or the like.
• If it happens to adhere to your skin, wash it off using plenty of water.
• If a reagent happens to enter your eye, wash it off immediately using
plenty of water, and take medical treatment at once.
• After unpacking, be sure not to allow dust or dirt to come into the
instrument. Use up CELLPACK within 60 days from the unpacking
date, and STROMATOLYSER-WH within 90 days.
CAUTION: • When the diluent (CELLPACK) tube is more than 2 m long, it may be
impossible to have reagent aspirated. Avoid setting CELLPACK at a
level higher than the instrument; otherwise, reagent may flow into the
vacuum line, possibly damaging the instrument.
CAUTION: • After connecting the tube, do not pull it by force for reagent
replacement.
CAUTION
Sysmex KX-21N Operator’s Manual -- Revised May 2003
INSTALLATION
A-8 Sysmex KX-21N Operator’s Manual -- October 1999
5.3 Connect STROMATOLYSER-WH
(1) Gently remove the provided float switch No. 23 from the dust-protection bag.
(2) Install the float switch No. 23 to STROMATOLYSER-WH. Then, set it to the table.
STROMATOLYSER-WH
Float switch No. 23
Figure A-5-3: Installing the STROMATOLYSER-WH
INSTALLATION
Sysmex KX-21N Operator’s Manual -- October 1999 A-9
5.4 Connect Waste Line
(1) Prepare the following waste line tube.
Tube Polyurethane 6 mmID × 9 mmOD : 1 pc
(2) Connect an end of the tube polyurethane 6 mmID × 9 mmOD to the drain outlet nipple
behind the unit. Connect the other end of the tube to the waste sewer in the lab.
If the waste sewer is not available, connect it to a waste tank.
The maximum waste line length is 6 m.
NOTE: • Cut the tube to an appropriate length, and connect it.
• Since waste is removed from the system by pressurized air, the waste
tank may be located at the same height as, or lower than, the drain
outlet nipple. Otherwise the waste may be flown back into the
system, which will result of a malfunction.
(3) Arrange and tie the diluent and waste line tubings as shown in the figure using the
provided clamp.
Drain Outlet Nipple
Tube Polyurethane 6 mmID × 9 mmOD
Waste Sewer
or
Waste Tank
Clamp
Diluent Inlet Nipple
Figure A-5-4: Connecting the Waste Line and Clamping Tubings
Sysmex KX-21N Operator’s Manual -- Revised May 2003
INSTALLATION
A-10 Sysmex KX-21N Operator’s Manual -- October 1999
6 . SET PRINTER PAPER
(1) Open the front cover of the main unit.
(2) Turn the release lever up to free the paper.
Release Lever
Figure A-6-1: Releasing the Lever
(3) Mount a printer paper.
Printer Paper
Figure A-6-2: Mounting a Printer Paper
Sysmex KX-21N Operator’s Manual -- Revised February 2000
INSTALLATION
Sysmex KX-21N Operator’s Manual -- October 1999 A-11
(4) Pass the printer paper as shown below, and turn the release lever down to secure.
Figure A-6-3: Securing the Release Lever
(5) Cut off any printer paper extending from the upper part of the printer.
Figure A-6-4: Cutting Off Paper
(6) Close the front cover of the main unit.
INSTALLATION
A-12 Sysmex KX-21N Operator’s Manual -- October 1999
7 . CONNECT POWER CORD AND CONNECTING CABLES
7.1 Connect Host Computer, Printer, and Hand Held Barcode
Reader
Connect to each instrument with connecting cables.
ID Reader Connector
GP Connector
DP Connector
Serial Interface
Figure A-7-1: Connecting the Connecting Cables
NOTE: • Perform setting concerning the output referring to Chapter 10,
Section 6: HOST SETTINGS, Chapter 10, Section 7: PRINTER
SETTINGS or Chapter 10, Section 8: ID READER SETTINGS to
use the connected external instruments.
7.2 Connect Power Cord
Connect the provided power cord to the power supply outlet.
Connect to the Power Supply Outlet
Power Cord
Figure A-7-2: Connecting the Power Cord
Sysmex KX-21N Operator’s Manual -- Revised May 2003
INSTALLATION
Sysmex KX-21N Operator’s Manual -- October 1999 A-13
8 . TURN POWER ON
It is necessary to run the service sequence at the initial start-up.
Your Sysmex service representative is responsible for the operation.
9 . REINSTALLING THE PROGRAM
The program is installed in the KX-21N in the factory, but when there is a necessity for
reinstalling the program by a problem or any other reason, reinstall the program according to
the following procedures.
(1) Turn OFF the power of the main unit.
(2) Loosen the screws of the card slot protective cover on the rear panel, and open the card
slot protective cover.
(3) Insert the program card in the card slot.
Figure A-8-1: Insert the Program Card
(4) Close the card slot protective cover, and turn ON the power.
(5) When "*Program Upgrade*" is displayed on the screen, press [1] key, and then install
the program.
When the installation is completed, the message "Installation was successful" will be
displayed.
(6) Turn OFF the power, and extract the program card.
(7) Close the card slot protective cover, and turn ON the power.
Sysmex KX-21N Operator’s Manual -- Revised May 2003
Sysmex KX-21N Operator’s Manual -- October 1999
TECHNICAL INFORMATION
APPENDIX B: TECHNICAL INFORMATION
1. OUTPUT FORMAT FOR HOST COMPUTER ......................................B-1
1.1 HARDWARE.......................................................................B-1
1.2 SOFTWARE........................................................................B-3
2. HAND HELD BAR CODE READER SPECIFICATIONS........................ B-15
Sysmex KX-21N Operator’s Manual -- Revised June 2001
TECHNICAL INFORMATION
Sysmex KX-21N Operator’s Manual -- October 1999 B-1
1 . OUTPUT FORMAT FOR HOST COMPUTER
The bit serial voltage type, which conforms to the RS-232C interface, is used for host
computer output of the KX-21N. The serial interface port for the connection with the host
computer is on the rear panel of the main unit.
1.1 Hardware
1 . Connector
• The connector for the output to the host computer is located on the rear panel.
• Use a 9-pin D-SUB, female connector.
• Fixing screws for this connector are in inch-specification.
2 . Connector Signals
Pin No. Signal Name Signal Direction
1
2 Receive data (R×D) From Host to KX-21N
3 Transmit Data (T×D) To Host from KX-21N
4 Data Terminal Ready (DTR) To Host from KX-21N
5 Signal Ground (SG)
6 Data Set Ready (DSR) From Host to KX-21N
7 Request to Send (RTS) To Host from KX-21N
8 Clear to Send (CTS) From Host to KX-21N
9
Table B-1-1: Pin Assignment
3 . Communication Format
The data is communicated in the asynchronous, full duplex mode.
4 . Signal Level
Signal level conforms to JIS C6361.
Level Data signal Control signal
+3V or higher Logic "1", Start bit ON
-3V or lower Logic "0", Stop bit OFF
Table B-1-2: Signal Level
Sysmex KX-21N Operator’s Manual -- Revised June 2001
TECHNICAL INFORMATION
B-2 Sysmex KX-21N Operator’s Manual -- October 1999
5 . Interface Circuit
• Output circuit
300 Ω
OUT
EMI filter
MC145407 Driver
Vss
VDD
Figure B-1-1: Interface Output Circuit
• Input circuit
IN
EMI filter
5.4 kΩ
MC145407 Receiver
15 kΩ
VDD
Vss
Figure B-1-2: Interface Input Circuit
TECHNICAL INFORMATION
Sysmex KX-21N Operator’s Manual -- October 1999 B-3
1.2 Software
1 . Communication Format
1 ) Code
ASCII codes are used for output.
(Except for K-DPS output)
2 ) Structure of text
"STX" (02 H) is sent prior to data and "ETX" (03 H) is sent at the end of data.
(Except for K-DPS output)
S
T
X
E
T
X
Order of transmission
Figure B-1-3: Order of Transmission
3 ) Communication protocol
The following 2 protocols are provided in the system, and can be selected according to
the system status.
• Class A
One-way transmission to the host computer without requiring ACK nor NAK from
host computer.
• Class B
The KX-21N transmits data and then waits for ACK or NAK to complete the data
transmission.
Analysis data is sent.
Analysis data transmission
is completed correctly.
Communication error
occurs.
Analysis data is sent
automatically (retrying up
to 3 times). If the reply is
still NAK after 3 retries,
instruction is made whether
the same data is sent again
or the transmission is
canceled by key input.
Analysis data is received.
When an error does not
occur, ACK (06H) is sent.
When an error occurs, NAK
(15H) is sent.
KX-21N Host computer
ACK
NAK
Figure B-1-4: Data Transmission
TECHNICAL INFORMATION
B-4 Sysmex KX-21N Operator’s Manual -- October 1999
4 ) Transmission errors
If the KX-21N detects a transmission error, the data transmission is canceled and an
error message is displayed. Re-transmission of the data ([1] key) or cancellation of the
transmission ([3] key) can be selected. Transmission errors occur in the following
situations.
• The computer is off line.
• The control signal DSR is off.
• After the data is transmitted, there is no response from the computer in 15 seconds.
(Class B only)
• After the data is transmitted, other than ACK or NAK is sent from the computer.
(Class B only)
• After the data is transmitted, the fourth NAK is sent. (Class B only. The KX-21N
resends the data automatically up to 3 times when NAK is sent.)
5 ) Timing, subject, and content of transmission
Serial interface
↓
Host computer
Normal analysis Analysis data (A)
Quality control QC data (A)
Table B-1-3: Content of Transmission
• Analysis data includes the date, sample ID No., parameter data, and the flag.
• QC data is X or L-J data.
• The setting of the connecting device is changed in the setting program.
2 . Text Format
The following three types of formats are used for computer output.
• KX-21N: Format for connecting to the host computer
• K-1000: Format for connecting to the host computer
• K-DPS: Special format for connecting to K-DPS
NOTE: • KX-21N format is selected at the time of shipping from the factory.
The details of KX-21N and K-1000 format are as follows.
• KX-21N format
KX-21N format has two formats; one is "analysis data format" for output of the
sample data, and the other is "QC data format" for output of the QC data. They
differ in length and content of the text. (They are distinguished by the sample
distinction code.)
The text distinction code II is fixed at "1".
However, when the text exceeds 256 bytes in a future modification, the text is
divided into 2 or more blocks. The number in text distinction code II shows the
order of the blocks. The ETB (17 H) is not used.
Sysmex KX-21N Operator’s Manual -- Revised June 2001
TECHNICAL INFORMATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. B-5
(1) Analysis data format
Parameter No. of Characters Example
STX 1 (02 H)
Text distinction code I 1 "D"
Text distinction code ll 1 "1"
Sample distinction code 1 "U"
Year 4 "1999"
Month 2 "09"
Day 2 "30"
Analysis information 1 (O)
Sample ID No. 15 (OOOOOOOOOOOOOOO)
PDA information 6 (OOOOOO)
Reserve 1 "O"
WBC [×103
/µL] 5 XXX.XF
RBC [×106
/µL] 5 XX.XXF
HGB [g/dL] 5 XXX.XF
HCT [%] 5 XXX.XF
MCV [fL] 5 XXX.XF
MCH [pg] 5 XXX.XF
MCHC [g/dL] 5 XXX.XF
PLT [×103
/µL] 5 XXXXF
LYM% (W-SCR) [%] 5 XXX.XF
MXD% (W-MCR) [%] 5 XXX.XF
NEUT% (W-LCR) [%] 5 XXX.XF
LYM# (W-SCC) [×103
/µL] 5 XXX.XF
MXD# (W-MCC) [×103
/µL] 5 XXX.XF
NEUT# (W-LCC) [×103
/µL] 5 XXX.XF
RDW-SD [fL] 5 XXX.XF
RDW-CV [%] 5 XXX.XF
(Dummy) 5 XXX.XF
MPV [fL] 5 XXX.XF
(Dummy) 5 XXX.XF
ETX 1 (03 H)
Total 131
Table B-1-4: Analysis Data Format
Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
TECHNICAL INFORMATION
B-6 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
(2) QC data format
Parameter No. of Characters Example
STX 1 (02 H)
Text distinction code I 1 "D"
Text distinction code II 1 "1"
Sample distinction code 1 "C"
Data distinction code 1 "X" or "L"
Year 4 "1999"
Month 2 "09"
Day 2 "30"
Hour 2 "09"
Minute 2 "59"
QC File Number 1 "5"
Not used 1 "0"
Reserve 1 "0"
WBC [×103
/µL] 4 XXX.X
LYM% (W-SCR) [%] 4 XXX.X
MXD% (W-MCR) [%] 4 XXX.X
NEUT% (W-LCR) [%] 4 XXX.X
LYM# (W-SCC) [×103
/µL] 4 XXX.X
MXD# (W-MCC) [×103
/µL] 4 XXX.X
NEUT# (W-LCC) [×103
/µL] 4 XXX.X
RBC [×106
/µL] 4 XX.XX
HGB [g/dL] 4 XXX.X
HCT [%] 4 XXX.X
MCV [fL] 4 XXX.X
MCH [pg] 4 XXX.X
MCHC [g/dL] 4 XXX.X
RDW- SD [fL] 4 XXX.X
RDW- CV [%] 4 XXX.X
PLT [×103
/µL] 4 XXXX
(Dummy) 4 XXX.X
MPV [fL] 4 XXX.X
(Dummy) 4 XXX.X
W-SMV [fL] 4 XXX.X
W-LMV [fL] 4 XXX.X
ETX 1 (03 H)
Total 105
Table B-1-5: QC data format
Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
TECHNICAL INFORMATION
Sysmex KX-21N Operator’s Manual -- October 1999 B-7
(3) Details of the analysis data output in KX-21N format
1) The order of output is from the top parameter to the bottom. The data is sent
from the upper line without performing zero suppression.
2) Because the decimal point is not sent, the decimal point specified in each
parameter has to be added and represented by numeric value at the host
computer.
3) Analysis information shows the following content of the analysis.
Manual No. input
WB mode analysis "0"
Pre-diluted mode analysis "5"
Table B-1-6: Analysis Information
4) PDA information consists of the following 6 items.
Item No. of Characters
WBC histogram information 1
WBC histogram flag 1
RBC histogram information 1
RBC histogram flag 1
PLT histogram information 1
PLT histogram flag 1
Table B-1-7: PDA Information
Code Description
"0" Histogram is normal.
"1" Histogram is abnormal.
"2" Manually discriminated
Table B-1-8: Histogram Information
Sysmex KX-21N Operator’s Manual -- Revised June 2001
TECHNICAL INFORMATION
B-8 Sysmex KX-21N Operator’s Manual -- October 1999
Code Description
"0" Normal
WBC/RBC/PLT
"1" (L) discriminator degree is high.
WBC/RBC/PLT
"2" (U) discriminator degree is high.
WBC/RBC/PLT
"3" Analysis is impossible because there is no pair of intersection on the 20%
degree level for calculation of DW.
RBC/PLT
"4" Two peaks are recognized in the particle distribution.
RBC/PLT
"5" (T1) discriminator cannot be determined.
WBC
"6" (T2) discriminator cannot be determined.
WBC
"7" (T1) discriminator level is high, and the data is not reliable.
WBC
"8" (T1) or (T2) discriminator level is high, and the data is not reliable.
WBC
"9" (T2) discriminator level is high, and the data is not reliable.
WBC
"A" The particle count equal to or less than (L) discriminator exceeds the range.
WBC
Table B-1-9: Histogram Flag
The histogram flag corresponds to the flagging characters of the LCD and the printer as
follows.
Particle distribution Flagging characters of LCD and printer
FLAG WBC RBC PLT
“0”
“1” WL RL PL
“2” WU RU PU
“3” DW DW
“4” MP MP
“5” T1
“6” T2
“7” F1
“8” F2
“9” F3
"A" AG
Table B-1-10: Flagging Character
Sysmex KX-21N Operator’s Manual -- Revised June 2002
TECHNICAL INFORMATION
Sysmex KX-21N Operator’s Manual -- October 1999 B-9
5) The numerical data configuration in the Analysis Data Format is as follows.
Upper digit Lower digit
Data Flag
Figure B-1-5: Numerical Data Configuration
Code Description
"0" Normal
"1" Abnormality judgment is "+."
"2" Abnormality judgment is "-."
"3" Out of linearity limit
"4" Reliability is low.
Table B-1-11: Details of Flag
6) In case of analysis error, or if the data lacks some data such as the calculation
parameter in pre-diluted mode, the data is transmitted as follows:
*0000
• K-1000 format
K-1000 format has two formats; one is "analysis data format" for output of the
sample data, and the other is "QC data format" for output of the QC data. They
differ in length and content of the text. (They are distinguished by the sample
distinction code.)
The text distinction code II is fixed at "1".
However, when the text exceeds 256 bytes in a future modification, the text is
divided into 2 or more blocks. The number in text distinction code II shows the
order of the blocks. The ETB (17 H) is not used.
Sysmex KX-21N Operator’s Manual -- Revised June 2002
TECHNICAL INFORMATION
B-10 Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
(1) Analysis data format
Parameter No. of Characters Example
STX 1 (02 H)
Text distinction code I 1 "D"
Text distinction code ll 1 "1"
Sample distinction code 1 "U"
Year 2 "99"
Month 2 "09"
Day 2 "30"
Analysis information 1 (O)
Sample ID No. 12 (OOOOOOOOOOOO)
PDA information 6 (OOOOOO)
RDW select information 1 "S" or "C"
WBC [×103
/µL] 5 XXX.XF
RBC [×106
/µL] 5 XX.XXF
HGB [g/dL] 5 XXX.XF
HCT [%] 5 XXX.XF
MCV [fL] 5 XXX.XF
MCH [pg] 5 XXX.XF
MCHC [g/dL] 5 XXX.XF
PLT [×103
/µL] 5 XXXXF
LYM% (W-SCR) [%] 5 XXX.XF
MXD% (W-MCR) [%] 5 XXX.XF
NEUT% (W-LCR) [%] 5 XXX.XF
LYM# (W-SCC) [×103
/µL] 5 XXX.XF
MXD# (W-MCC) [×103
/µL] 5 XXX.XF
NEUT# (W-LCC) [×103
/µL] 5 XXX.XF
RDW-SD/CV [fL/%] 5 XXX.XF
(Dummy) 5 XXX.XF
MPV [fL] 5 XXX.XF
(Dummy) 5 XXX.XF
ETX 1 (03 H)
Total 121
Table B-1-12: Analysis Data Format
Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
TECHNICAL INFORMATION
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. B-11
(2) QC data format
Parameter No. of Characters Example
STX 1 (02 H)
Text distinction code I 1 "D"
Text distinction code II 1 "1"
Sample distinction code 1 "C"
Data distinction code 1 "X" or "L"
Year 2 "97"
Month 2 "09"
Day 2 "30"
Hour 2 "09"
Minute 2 "59"
QC File Number 1 "5"
Not used 1 "0"
RDW select information 1 "C"
WBC [×103
/µL] 4 XXX.X
LYM% (W-SCR) [%] 4 XXX.X
MXD% (W-MCR) [%] 4 XXX.X
NEUT% (W-LCR) [%] 4 XXX.X
LYM# (W-SCC) [×103
/µL] 4 XXX.X
MXD# (W-MCC) [×103
/µL] 4 XXX.X
NEUT# (W-LCC) [×103
/µL] 4 XXX.X
RBC [×106
/µL] 4 XX.XX
HGB [g/dL] 4 XXX.X
HCT [%] 4 XXX.X
MCV [fL] 4 XXX.X
MCH [pg] 4 XXX.X
MCHC [g/dL] 4 XXX.X
RDW-(CV/SD) [%/fL] 4 XXX.X
PLT [×103
/µL] 4 XXXX
(Dummy) 4 XXX.X
MPV [fL] 4 XXX.X
(Dummy) 4 XXX.X
W-SMV [fL] 4 XXX.X
W-LMV [fL] 4 XXX.X
ETX 1 (03 H)
Total 99
Table B-1-13: QC data format
Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
TECHNICAL INFORMATION
B-12 Sysmex KX-21N Operator’s Manual -- October 1999
(3) Details of the analysis data output in K-1000 format
1) The order of output is from the top parameter to the bottom. The data is sent
from the upper line without performing zero suppression.
2) Because the decimal point is not sent, the decimal point specified in each
parameter has to be added and represented by numeric value at the host
computer.
3) Analysis information shows the following content of the analysis.
Manual No. input
WB mode analysis "0"
Pre-diluted mode analysis "5"
Table B-1-14 Analysis Information
4) The sample ID No. is 15-digit numerals, but 12 digits are output in this format.
The upper 3 digits are deleted. Depending on the usage, "-" (2D H) may be
inserted in the numeral column. In this case, "-" is included in the 12 digits.
5) PDA information consists of the following 6 items.
Item No. of Characters
WBC histogram information 1
WBC histogram flag 1
RBC histogram information 1
RBC histogram flag 1
PLT histogram information 1
PLT histogram flag 1
Table B-1-15: PDA Information
Code Description
"0" Histogram is normal.
"1" Histogram is abnormal.
"2" Manually discriminated
Table B-1-16: Histogram Information
Sysmex KX-21N Operator’s Manual -- Revised June 2001
TECHNICAL INFORMATION
Sysmex KX-21N Operator’s Manual -- October 1999 B-13
Code Description
"0" Normal
WBC/RBC/PLT
"1" (L) discriminator degree is high.
WBC/RBC/PLT
"2" (U) discriminator degree is high.
WBC/RBC/PLT
"3" Analysis is impossible because there is no pair of intersection on the 20%
degree level for calculation of DW.
RBC/PLT
"4" Two peaks are recognized in the particle distribution.
RBC/PLT
"5" (T1) discriminator cannot be determined.
WBC
"6" (T2) discriminator cannot be determined.
WBC
"7" (T1) discriminator level is high, and the data is not reliable.
WBC
"8" (T1) or (T2) discriminator level is high, and the data is not reliable.
WBC
"9" (T2) discriminator level is high, and the data is not reliable.
WBC
"A" The particle count equal to or less than (L) discriminator exceeds the range.
WBC
Table B-1-17: Histogram Flag
The histogram flag corresponds to the flagging characters of the LCD and the printer as
follows.
Particle distribution Flagging characters of LCD and printer
FLAG WBC RBC PLT
“0”
“1” WL RL PL
“2” WU RU PU
“3” DW DW
“4” MP MP
“5” T1
“6” T2
“7” F1
“8” F2
“9” F3
"A" AG
Table B-1-18: Flagging Character
Sysmex KX-21N Operator’s Manual -- Revised June 2002
TECHNICAL INFORMATION
B-14 Sysmex KX-21N Operator’s Manual -- October 1999
6) RDW select information
It shows whether RDW-CV or RDW-SD is output.
"C": RDW-CV
"S": RDW-SD
NOTE: • RDW-SD is selected at the initial setting of K-1000.
• To output RDW-CV, refer to Chapter 10, Section 6: HOST
SETTINGS.
7) The numerical data configuration in the Analysis Data Format is as follows.
Upper digit Lower digit
Data Flag
Figure B-1-6: Numerical Data Configuration
Code Description
"0" Normal
"1" Abnormality judgment is "+."
"2" Abnormality judgment is "-."
"3" Out of linearity limit
"4" Reliability is low.
Table B-1-19: Details of Flag
8) In case of analysis error, or if the data lacks some data such as the calculation
parameter in pre-diluted mode, the data is transmitted as follows:
*0000
Sysmex KX-21N Operator’s Manual -- Revised June 2002
TECHNICAL INFORMATION
Sysmex KX-21N Operator’s Manual -- October 1999 B-15
2. HAND HELD BAR CODE READER SPECIFICATIONS
1. Hardware Specifications
1) Specification
(1) The kind of Bar Code: UPC-A, UPC-E, CODE39, CODE128, ITF, NW-7
(2) Decoder: Built-in a reading head.
(3) Interface: RS-232C
(4) Connector: DIN 8P
(5) Power Supply: DC5V+/-5%
2) Pin Arrangement of Connector (DIN 8P)
Pin No. Signal name Direction of signal
1 TXD Transmitting Data to HOST
2 RXD Receiving Data from HOST
3 RTS Request to Send to HOST
4 CTS Clear to Send from HOST
5 NC
6 DTR Data Terminal ready to HOST
7 SG Signal Ground
8 +5V from HOST
3) Data Transmission Procedure
PRE (ID) DATA POST
PRE: STX
POST: ETX
2. Software Specifications
1) Communication Protocol
Baud Rate 2400
Code 7-bit
Stop Bit 2-bit
Parity Even
RTS/CTS Use
Protocol None
Preamble Transmit STX
Postamble Transmit ETX
Sysmex KX-21N Operator’s Manual -- Revised November 2000
TECHNICAL INFORMATION
B-16 Sysmex KX-21N Operator’s Manual -- October 1999
2) Protocol
RTS/CTS Effective
Non Protocol
3) Format
STX DATA ETX
4) The Kind of Bar Code
(1) CODE39
Data can be transmitted without Check Digits, since Check Digits (MOD-43) is judged within
Bar Code Reader.
All data may be transmitted with Check Digits, but with no-effect.
(2) JAN, UPC-A, UPC-E, EAN13, EAN8
Data can be transmitted without Check Digits, since Check Digits (MOD-10) is judged within
Bar Code Reader.
(3) NW-7
Data can be transmitted without Check Digits, since Check Digits (MOD-16) is judged within
Bar Code Reader.
All data except Start/Stop Code may be transmitted by the setup of the Check Digits, but with
no-effect.
(4) ITF
Data can be transmitted without Check Digits, since Check Digits (MOD-10) is judged within
Bar Code Reader.
All data may be transmitted with Check Digits, but with no-effect.
(5) CODE128
Data can be transmitted without Check Digits, since Check Digits (MOD-103) is judged
within Bar Code Reader.
3. Setting for Each Bar Code Symbology
Set the optional manual ID Bar Code Reader, as specified for each bar code symbology.
1) Code39
Check Digit=Use
Check Digit=Not transmit
ST/SP=Not transmit
Full ASCII=Non
Multi-read=No
ID Character=Not transmit
Sysmex KX-21N Operator’s Manual -- Revised November 2000
TECHNICAL INFORMATION
Sysmex KX-21N Operator’s Manual -- October 1999 B-17
2) NW-7
Check Digit=Not transmit
ST/SP=Not transmit
ST/SP Character=a, b, c, d
Hex Format=No
ID Character=Not transmit
3) UPC-A, UPC-E, EAN13, EAN8
Check Digit=Not transmit
Add-On=No
ID Character=Not transmit
4) ITF
Check Digit=Not transmit
ID Character=Not transmit
5) Code128
Check Digit=Use
Check Digit=Not transmit
ID Character=Not transmit
Sysmex KX-21N Operator’s Manual -- Revised November 2000
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. i
INDEX
A
Adjusting Pressure to 0.05 MPa --------------8-5
Adjusting Vacuum to 0.0333 MPa-----------8-6
Adjustment of Pressure and Vacuum --------8-2
Alarm Sounds -------------------------------- 1-13
Alphabetical List of Error Messages
Displayed on Analysis Screen ---------7-3
Alphabetical List of Error Messages
Displayed on HELP Screen ------------7-4
Analysis Errors------------------------------- 7-17
Analysis of Histogram----------------------- 9-11
Analysis of RBC/PLT Histogram ----------- 9-20
Analysis of WBC Histogram ---------------- 9-11
Analysis Parameters----------------------------1-5
Analysis Procedure Flow Chart --------------2-2
As-Needed Maintenance and Procedure--- 4-24
Auto Rinse------------------------------------ 4-24
Automatic Calibration -------------------------6-5
Automatic Calibration Procedure-------------6-6
Automatic Stop Function of Pneumatic Unit1-4
B
Blood Cell Discrimination Circuit ---------- 9-10
C
Calculating Calibration Value--------------- 6-11
Calculation of RBC Constant -----------------9-9
Calibration--------------------------------------6-1
Calibration Flow Chart ------------------------6-4
Calibration History Print -------------------- 6-25
Calibrator Calibration-------------------6-3, 6-15
Calibrator Calibration Procedure ----------- 6-17
Calibrator Calibration Program---------------6-1
CBC Analysis-----------------------------------9-5
Cell Count Parameters ----------------------- 2-28
Chamber Errors ------------------------------ 7-10
Check before Installation--------------------- A-2
Check Trap Chamber Level and Discard ----4-6
Clean Rinse Cup------------------------------ 4-26
Clean Sample Rotor Valve (SRV) ---------- 4-16
Clean SRV Tray--------------------------------4-7
Clean TD Chamber and Diluted Sample
Line (Shutdown) ------------------------4-4
Clean Transducer (Rinse Sequence)-------- 4-12
Clean Waste Chamber (Rinse Sequence)-----4-9
Clean WBC/RBC Transducer Aperture ----- 4-28
Confirmation of Cycle Number ------------ 4-41
Connect Cables-------------------------------A-12
Connect CELLPACK ------------------------- A-6
Connect Host Computer---------------------A-12
Connect Hand Held Barcode Reader-------A-12
Connect Power Cord-------------------------A-12
Connect Printer-------------------------------A-12
Connect STROMATOLYSER-WH ---------- A-8
Connect Tube --------------------------------- A-6
Connect Waste Line--------------------------- A-9
Contents of Display----------------------------1-8
Connects of Package------------------------- 1-13
Correcting a Sample Number--------------- 3-23
D
Daily Maintenance and Procedure -----------4-4
Date/Time Settings --------------------------- 10-8
DC Detection Method -------------------------9-2
Deletion--------------------------------------- 5-27
Deletion (Stored Data)----------------------- 3-20
Detection Principle-----------------------------9-2
Display and Printing of Analysis Result --- 2-24
Display of Analysis Result -------------2-24, 3-2
DP Output Settings--------------------------10-23
E
Electric System------------------------------- 9-28
Emergency Stop Procedure----------------- 1-12
Erase All ----------------------------------------5-7
Error History Print -------------------------- 7-36
Every 3-Month Maintenance and
Procedure ----------------------------- 4-16
Execute X Control--------------------------- 5-10
Execute L-J Control ------------------------- 5-19
Execute QC Program --------------------------5-5
Executing and Quitting Stored Data
Processing Program------------------- 3-14
Executing Automatic Calibration Program- 6-5
Executing Calibrator Calibration Program 6-15
Execution of Shutdown --------------------- 2-32
Exit from QC Control Program------------- 5-26
Expected Results ----------------------------- 2-30
External Device Errors ---------------------- 7-33
External Output ----------------- 3-11,3-21,5-31
Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.
ii Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
F
Factory Setting ------------------------------10-38
Front Interior--------------------------------- 9-31
Front Panel ----------------------------------- 9-30
Functional List of Error Messages------------7-5
G
GP/LP Output Settings----------------------10-25
Graphic Screen---------------------------------1-8
Grounding------------------------------------ 1-14
H
Hand Held Bar Code
Reader Specifications-----------------B-15
Hardware--------------------------------------- B-1
HGB/HCT Calibration -------------------------6-3
HGB/HCT Calibration Samples ---------------6-3
Host Settings---------------------------------10-17
I
ID Reader Settings --------------------------10-30
Inspection before Turning ON the Power ---2-3
Installation and Relocation------------------ 1-14
Installation Environment ------------- 1-14, 1-16
Installation Space ---------------------- 1-15, A-3
Instrument Specifications ------------------- 1-17
IP Output Settings---------------------------10-27
K
KX-21N Maintenance Checklist--------------4-2
L
LCD Brightness Adjustment ---------------- 1-12
Left Side Interior----------------------------- 9-34
Left Side Panel ------------------------------- 9-33
Levy-Jennings Control (L-J)------------------5-1
Limitation of Hemoglobin ------------------ 2-29
Limitations------------------------------------ 2-28
Location of Control Knobs -------------------8-2
M
Maintenance Errors-------------------------- 7-27
Manual Calibration -------------------------- 6-11
Manual Calibration Procedure-------------- 6-12
Manual Discrimination ------------------------3-7
Measuring Unit Hydraulic System
Block Diagram --------------------------9-4
Memory Errors------------------------------- 7-23
Menu Tree------------------------------------ 1-20
Monthly Maintenance and Procedure--------4-9
Motor Errors --------------------------------- 7-13
N
Names and Functions of Instruments ------ 9-30
Non-Cyanide Hemoglobin Analysis
Method ----------------------------------9-2
O
Operation Procedure------------------------- 4-41
Option Units------------------------------------1-3
Others ----------------------------------------- 7-25
Outline of Operation---------------------------1-4
Output Format for Host Computer ---------- B-1
Output of Analysis Result to Host
Computer ------------------------------ 2-27
Output to Host Computer ------------------- 5-35
Overview of Analysis Modes------------------2-1
Overview of Instrument------------------------1-2
P
Panel Keyboard --------------------------------1-7
Password Settings ---------------------------10-32
Patient Limit---------------------------------10-11
Peripheral Settings --------------------------10-36
PLT Discriminator --------------------------- 9-10
Pre-Diluted (PD) Mode---------------------- 2-16
Precision Check --------------------------------6-2
Precision Check Sample-----------------------6-2
Preparation for Calibration--------------------6-2
Prepare Reagent------------------------------- A-6
Pressure and Vacuum Display ---------------8-3
Pressure/Vacuum Errors-----------------------7-7
Print Set Values -----------------------------10-35
Printer Errors -------------------------------- 7-30
Printer Settings ------------------------------10-22
Printing of Analysis Result------------------ 2-25
Printing to Printer---------------------------- 5-31
Procedures in each Analysis Mode-----------2-9
Processing Latest Samples---------------------3-2
Processing Stored Data ---------------------- 3-14
Program Version----------------------------- 7-37
Q
QC Analysis Procedure------------------------5-4
QC Analysis Procedure Flow Chart-----------5-4
QC Chart Screen -------------------------------5-2
QC Settings ----------------------------------10-14
Quality Control---------------------------------2-8
Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
Sysmex KX-21N Operator’s Manual -- October 1999 N.A. iii
R
RBC Discriminator--------------------------- 9-10
RBC/PLT Analysis Flow -----------------------9-7
Rear Panel ------------------------------------ 9-35
Reference Values-------------------------------6-3
Reinstalling the Program --------------------A-13
Remove Shipping Clamps-------------------- A-4
Replace Fuse---------------------------------- 4-36
Replace Printer Paper------------------------ 4-37
Replace Waste Tank-------------------------- 4-32
Replenish Reagent --------------------------- 4-33
Reset SRV Cycle Counter ------------------- 4-22
Right Side Panel------------------------------ 9-32
S
Select QC File ----------------------------------5-6
Set Printer Paper -----------------------------A-10
Set TARGET/LIMIT Values ------------------5-8
Shutdown Procedure------------------------- 2-32
Software---------------------------------------- B-3
Start-up Procedure-----------------------------2-3
Status Display -------------------------------- 7-34
Status Display Messages ----------------------1-9
Stopping the Pneumatic Unit --------------- 2-31
Stored Data Screen--------------------------- 3-15
Supplies List---------------------------------- 4-40
Supplies Replacement ----------------------- 4-33
System Setup --------------------------------- 10-3
T
Temperature Errors-------------------------- 7-16
Transducer Errors---------------------------- 7-15
Troubleshooting Guide------------------------7-7
Turn Power ON ------------------------------A-13
Turning ON the Power and Self-Check------2-5
W
WBC Discriminator -------------------------- 9-10
WBC/HGB Analysis Flow----------------------9-5
Weekly Maintenance and Procedure ---------4-7
When You Suspect a Trouble -----------------7-2
Whole Blood (WB) Mode---------------------2-9
X
X Control---------------------------------------5-1
Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.

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Kx 21 n-na_0305

  • 1. OPERATOR’S MANUAL AUTOMATED HEMATOLOGY ANALYZER KX-21N(North American Edition) CHAPTER 1: INTRODUCTION CHAPTER 2: SAMPLE ANALYSIS CHAPTER 3: DISPLAY AND PROCESSING OF ANALYSIS RESULTS CHAPTER 4: MAINTENANCE AND SUPPLIES REPLACEMENT CHAPTER 5: QUALITY CONTROL CHAPTER 6: CALIBRATION CHAPTER 7: TROUBLESHOOTING CHAPTER 8: ADJUSTMENT CHAPTER 9: FUNCTIONAL DESCRIPTION CHAPTER 10: INSTRUMENT SETUP APPENDIX A: INSTALLATION APPENDIX B: TECHNICAL INFORMATION INDEX SYSMEX CORPORATION KOBE, JAPAN Copyright  1999 - 2003 by SYSMEX CORPORATION All rights reserved. No part of this Operator’s Manual may be Code No. 461-2264-1 reproduced in any form or by any means whatsoever without PRINTED IN JAPAN prior written permission of SYSMEX CORPORATION. Date of Last Revision: May 2003
  • 2. Sysmex KX-21N Operator’s Manual -- Revised February 2000 • Sysmex is a registered trademark of SYSMEX CORPORATION. • CELLCLEAN, CELLPACK, EIGHTCHECK-3WP, and STROMATOLYSER-WH are trademarks of SYSMEX CORPORATION. • Cubitainer is a registered trademark of Hedwin Corporation. • ESC/P is a registered trademark of Seiko Epson Corporation. • PCL is a registered trademark of Hewlett-Packard Company. • Teflon is a registered trademark of E.I. du Pont de Nemours & Co., Inc. • VENOJECT is a registered trademark of Terumo Corporation. • Other trademarks referenced are property of their respective owners. • It is prohibited to reproduce part or all of the contents of this Manual without permission. • The display screens carried in this Manual may in some cases differ from actual screens. • We reserve the right to make further improvements and incorporate them in our products, which then will have some points that differ from descriptions in this Manual. • Patient names and doctor names are entered for information and illustration purposes only, and do not imply real specific persons.
  • 3. Sysmex KX-21N Operator’s Manual -- October 1999 I RECEIVING INSTRUCTIONS The KX-21N has been thoroughly tested before shipment, and has been packaged carefully to prevent damage from shipping and handling. Reagents and options have also been sent and will arrive at approximately the same time as the analyzer. Follow these guidelines when the system arrives: • Check to see that the arrows on the sides of the packages are pointing up. If the arrows do not point up, remark this information on the bill of lading. • Visually inspect the outside of the package for rips, dents, or possible shipping damage. Document any sign of damage on the bill of lading, regardless of how insignificant it may appear. This is for your protection! • Notify your service representative that the KX-21N system and its components have arrived. • Wait for your service representative to unpack the system and open the packages. • Follow the unpacking and storage instructions provided on the outside of the package. Special requirements such as refrigeration are clearly marked on the outside of the carton and will be included in the unpacking instructions and package inserts. WARRANTY INFORMATION All instruments manufactured by Sysmex® are warranted against defective materials or workmanship for a period of one year commencing on the installation date at the customer's required location. This Warranty does not cover any defect, malfunction, or damage due to: 1. Accident, neglect or willful mistreatment of the product 2. Failure to use, operate, service, or maintain the product in accordance with the applicable Sysmex Operator's Manual 3. Failure to use the appropriate reagents or chemicals specified for the product
  • 4. Sysmex KX-21N Operator’s Manual -- October 1999II ENSURE SAFE OPERATION OF THE INSTRUMENT Before operating this instrument, carefully read the "Ensure Safe Operation of the Instrument" and OPERATOR’S MANUAL, and strictly follow the instructions given in them. This manual carries a variety of illustrations to make sure that the product can be used safely and correctly, thus preventing you and others from suffering injuries and damage to property. The illustrations and meaning are described in the following. Do understand what they mean before proceeding to the text of the MANUAL. Meaning of Signs • If this sign is ignored and the instrument is operated incorrectly, there is a potentially hazardous situation which could result in death or serious injury of an operator, or grave property damage. • If this sign is ignored and the instrument is operated incorrectly, there is a potentially hazardous situation which may result in injury of an operator, adverse effect on output results, or will cause property damage. Caution on Diagnosis • This product is a clinical instrument for screening of abnormalities. Clinical judgments by physicians should take into account results from clinical examinations and other test results besides hematology result. WARNING CAUTION CAUTION
  • 5. Sysmex KX-21N Operator’s Manual -- October 1999 III WARNING • In the event the instrument emits abnormal odor or any smoke, turn off the power immediately and disconnect the power plug from the wall socket. If the instrument is used continuously in that state, there is a hazard that fire, electrical shock, or injury may result. Contact your Sysmex service representative for inspection. • Take care not to spill blood or reagent, or drop wire staples or paper clips into the instrument. Those might cause short circuit or smoke emission. If such trouble should occur, turn off the power supply immediately and pull off the power plug from the wall socket. Then contact Sysmex service representative for inspection. • Do not touch the electrical circuits inside the cover. Especially if your hands are wet, there is a hazard that electrical shock may result. • Always wear rubber gloves when performing maintenance work or inspection. Use specified tools and parts. After work is over, wash your hands with disinfectant. There is a possibility that those areas of the hand which came in contact with blood could suffer infection, electrical shock, or burn. • Be careful when handling samples. Always wear rubber gloves; otherwise infection by bacteria could result. If bacteria happen to enter your eye or a cut, wash it off with plenty of water, and immediately see a doctor. • When discarding waste liquid, or disassembling/assembling the related parts, do not touch the waste liquid. If it is contaminated with blood, infection of bacteria may result. If you should touch the waste liquid inadvertently, wash it off with disinfectant first, then wash it off with soap. When Handling Reagent • If a reagent happens to enter your eye, wash it off immediately using plenty of water, and take medical treatment at once. • If you should swallow it inadvertently, call for a doctor immediately, drink plenty of water, and throw up. • If it happens to adhere to the hand or the skin of other area, wash it off using plenty of water. • When discarding waste liquid and instrument consumable, take proper disposing steps as medical, ineffective, and industrial wastes. If they are contaminated with blood, infection of bacteria may result. • Do not modify the instrument. (Modification is prohibited by Pharmaceutical Affairs Law in Japan.) Check the regulations that apply to laboratories in your country.
  • 6. Sysmex KX-21N Operator’s Manual -- October 1999IV WARNING Power Supply, Connection, and Grounding • Never put the power plug in any socket other than the specified voltage. Otherwise, fire or electrical shock will result. • When installing the instrument, be sure to ground it. Otherwise, fire or electrical shock will result. Handling Power Supply Cord • Take care not to damage the power cord, place a heavy device on it, or pull it forcibly. Otherwise, the wire may break causing fire or electrical shock. • When connecting the instrument to a peripheral (host computer, printer), be sure to switch off the power supply beforehand. Otherwise, electrical shock or instrument failure may result.
  • 7. Sysmex KX-21N Operator’s Manual -- October 1999 V CAUTION Use of Reagents • After unpacking, be sure not to allow dust, dirt, or bacteria to come in touch with the reagent. • Do not use reagents which are out of the expiration date. • Handle a reagent gently to prevent formation of bubbles. • Take care not to spill a reagent. If it spills, wipe it off immediately using a wet cloth or the like. • Follow other instructions described on the Package Insert on each reagent. Use of Instrument • When performing maintenance work or inspection, use specified tools and parts. Do not use substitute parts, or modify the instrument. It is hazardous. • Do not bring your body or clothes close to the instrument. • Those who have no or only limited experience in using reagents are recommended to have guidance or assistance of those with sufficient experience. • If the instrument has developed a trouble by any chance, a person in charge of it should take steps within the range specified in the OPERATOR’S MANUAL. As to troubles other than mentioned in it, contact Sysmex service representative for repair. • Unpacking, installation, and confirmation of initial operation must be done by Sysmex service representative. Environment for Use • Install the instrument in a place which is not subject to water splash. • Install the instrument in a place which is not subject to adverse effects of high temperature, high humidity, dust, direct sunlight, etc. • Do not give the instrument a strong vibration or impact. • Do not install the instrument near a chemical storage or a place where a gas is generated.
  • 8. Sysmex KX-21N Operator’s Manual -- October 1999 N.A.VI STRUCTURE OF THIS MANUAL Read this manual carefully so you will be able to use the instrument to its full extent, and operate it correctly. This manual contains ten Chapters and APPENDICES as listed in the following: Chapter 1: Introduction Describes overview of this instrument, including the outline of the instrument, operation procedure, and messages, and cautions during installation. Chapter 2: Sample Analysis Describes procedures for start-up of the instrument, measurement of the sample, and shut-down. Summarizes the operation method for analyzing the sample. Chapter 3: Display and Processing of Analysis Results Describes the displayed content of the analysis data, and the process of the latest sample/stored data. Also describes the manual analysis and the external output. Chapter 4: Maintenance and Supplies Replacement Describes scheduled maintenance and replacement method of supplies such as reagent. Chapter 5: Quality Control Describes execution procedures of the X control and L- J control for quality control. Chapter 6: Calibration Describes procedures for automatic, manual, and calibrator calibration. Chapter 7: Troubleshooting Describes error messages and troubleshooting. Chapter 8: Adjustment Describes the method of pressure adjustment based on the troubleshooting. Chapter 9: Functional Description Describes the analyzing principles of this instrument and names of the components. Chapter 10: Instrument Setup Describes the system environment setting such as date, time, and unit, and the data analysis setting such as data error judgment. Appendix A: Installation Describes the installation method of the KX-21N. Appendix B: Technical Information Technical reference data describing the specification for host output format.
  • 9. Sysmex KX-21N Operator’s Manual -- October 1999 VII INTRODUCTION Thank you for purchasing the Sysmex® Automated Hematology Analyzer KX-21N. Carefully read the OPERATOR'S MANUAL for correct use of the unit. Keep this MANUAL handy after reading. It will continue to be of your service in finding specific information about this instrument. Ordering of Supplies and Replacement Parts If you need to order supplies or replacement parts, please contact your local Sysmex representative. Service and Maintenance Please contact the Service Department of your local Sysmex representative. Training courses For further information please contact the Sysmex representative in your country. Sysmex KX-21N Operator’s Manual -- Revised August 2001
  • 10. Sysmex KX-21N Operator’s Manual -- Revised May 2002 N.A.VIII PREMISES FOR SIGNS Meaning of Signs • If this sign is ignored and the instrument is operated incorrectly, there is a potentially hazardous situation which could result in death or serious injury of an operator, or grave property damage. • If this sign is ignored and the instrument is operated incorrectly, there is a potentially hazardous situation which may result in injury of an operator, adverse effect on output results, or will cause property damage. CAUTION: • Indicates what we would like you to know to maintain instrument performance and prevent its damage. NOTE: • Indicates information which will come handy in operating the instrument. Document Conventions In explaining operation, this manual uses the conventions as shown below. • The keys on the panel keyboard are expressed within square brackets. For example: [SELECT], [ENTER], [ ] • The display on LCD appears within quotation marks. For example: "Stand-by," "WB" • The name of menu appears within quotation marks. For example: "2: Quality Control," "6: Settings" NOTE: • LCD and printing described in this manual may differ from that in practice. • Due to the improvement of the product, the content of this manual may not conform with the product. WARNING CAUTION
  • 11. Sysmex KX-21N Operator’s Manual -- October 1999 i KX-21N OPERATOR’S MANUAL TABLE OF CONTENTS CHAPTER 1: INTRODUCTION 1. INTRODUCTION.......................................................................................1-1 2. OVERVIEW OF INSTRUMENT...............................................................1-2 3. OPTION UNITS..........................................................................................1-3 4. OUTLINE OF OPERATION......................................................................1-4 5. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT ....................1-4 6. ANALYSIS PARAMETERS......................................................................1-5 7. PANEL KEYBOARD.................................................................................1-7 8. GRAPHIC SCREEN ...................................................................................1-8 8.1 Contents of Display............................................................................1-8 8.2 Status Display Messages....................................................................1-9 8.3 LCD Brightness Adjustment............................................................1-12 9. EMERGENCY STOP PROCEDURE.......................................................1-12 10. ALARM SOUNDS....................................................................................1-13 11. CONTENTS OF PACKAGE.....................................................................1-13 12. INSTALLATION ENVIRONMENT........................................................1-14 12.1 Installation and Relocation...............................................................1-14 12.2 Grounding.........................................................................................1-14 12.3 Installation Space .............................................................................1-15 12.4 Installation Environment..................................................................1-16 13. INSTRUMENT SPECIFICATIONS.........................................................1-17 14. MENU TREE.............................................................................................1-20 CHAPTER 2: SAMPLE ANALYSIS 1. INTRODUCTION.......................................................................................2-1 1.1 Overview of Analysis Modes.............................................................2-1 1.2 Analysis Procedure Flow Chart..........................................................2-2 2. START-UP PROCEDURE..........................................................................2-3 2.2 Inspection before Turning ON the Power ..........................................2-3 2.2 Turning ON the Power and Self-Check .............................................2-5 3. QUALITY CONTROL................................................................................2-8 4. PROCEDURES IN EACH ANALYSIS MODE.........................................2-9 4.1 Whole Blood (WB) Mode.................................................................2-9 4.2 Pre-Diluted (PD) Mode....................................................................2-16 5. DISPLAY AND PRINTING OF ANALYSIS RESULT..........................2-24 5.1 Display of Analysis Result...............................................................2-24 5.2 Printing of Analysis Result...............................................................2-25 5.3 Output of Analysis Result to Host Computer...................................2-27 6. LIMITATIONS..........................................................................................2-28 6.1 Cell Count Parameters......................................................................2-28 6.2 Limitation of Hemoglobin................................................................2-29 7. EXPECTED RESULTS.............................................................................2-30 8. STOPPING THE PNEUMATIC UNIT.....................................................2-31 9. EXECUTION OF SHUTDOWN ..............................................................2-32 9.1 Shutdown Procedure.........................................................................2-32
  • 12. ii Sysmex KX-21N Operator’s Manual -- Revised June 2001 CHAPTER 3: DISPLAY AND PROCESSING OFANALYSIS RESULTS 1. INTRODUCTION...................................................................................... 3-1 2. PROCESSING LATEST SAMPLES......................................................... 3-2 2.1 Display of Analysis Result................................................................ 3-2 2.2 Manual Discrimination...................................................................... 3-7 2.3 External Output ............................................................................... 3-11 3. PROCESSING STORED DATA............................................................. 3-14 3.1 Executing and Quitting Stored Data Processing Program............... 3-14 3.2 Stored Data Screen.......................................................................... 3-15 3.3 Deletion........................................................................................... 3-20 3.4 External Output ............................................................................... 3-21 3.5 Correcting a Sample Number.......................................................... 3-23 CHAPTER 4: MAINTENANCE AND SUPPLIES REPLACEMENT 1. INTRODUCTION...................................................................................... 4-1 2. KX-21N MAINTENANCE CHECKLIST................................................. 4-2 3 DAILY MAINTENANCE AND PROCEDURE....................................... 4-4 3.1 Clean TD Chamber and Diluted Sample Line (Shutdown)............... 4-4 3.2 Check Trap Chamber Level and Discard.......................................... 4-6 4. WEEKLY MAINTENANCE AND PROCEDURE................................... 4-7 4.1 Clean SRV Tray .................................................................................4-7 5. MONTHLY MAINTENANCE AND PROCEDURE................................ 4-9 5.1 Clean Waste Chamber (Rinse Sequence)...........................................4-9 5.2 Clean Transducer (Rinse Sequence).................................................4-12 6. EVERY 3-MONTH MAINTENANCE AND PROCEDURE................. 4-16 6.1 Clean Sample Rotor Valve (SRV)....................................................4-16 6.2 Reset SRV Cycle Counter ...............................................................4-22 7. AS-NEEDED MAINTENANCE AND PROCEDURE........................... 4-24 7.1 Auto Rinse........................................................................................4-24 7.2 Clean Rinse Cup...............................................................................4-26 7.3 Clean WBC/RBC Transducer Aperture...........................................4-28 7.4 Replace Waste Tank.........................................................................4-32 8. SUPPLIES REPLACEMENT.................................................................. 4-33 8.1 Replenish Reagent............................................................................4-33 8.2 Replace Fuse.....................................................................................4-36 8.3 Replace Printer Paper.......................................................................4-37 8.4 Supplies List.....................................................................................4-40 9. CONFIRMATION OF CYCLE NUMBER ............................................. 4-41 9.1 Operation Procedure........................................................................ 4-41
  • 13. Sysmex KX-21N Operator’s Manual -- October 1999 N.A. iii CHAPTER 5: QUALITY CONTROL 1. INTRODUCTION................................................................. 5-1 1.1 X Control ................................................................... 5-1 1.2 Levy-Jennings Control (L-J) .............................................. 5-1 1.3 QC Chart Screen............................................................ 5-2 2. QC ANALYSIS PROCEDURE ................................................. 5-4 2.1 QC Analysis Procedure Flow Chart...................................... 5-4 2.2 Execute QC Program....................................................... 5-5 2.3 Select QC File............................................................... 5-6 2.4 Erase All ..................................................................... 5-7 2.5 Set TARGET/LIMIT Values.............................................. 5-8 2.6 Execute X Control.........................................................5-10 2.7 Execute L-J Control .......................................................5-19 2.8 Exit from QC Control Program..........................................5-26 3. DELETION........................................................................5-27 4. EXTERNAL OUTPUT ..........................................................5-31 4.1 Printing to Printer..........................................................5-31 4.2 Output to Host Computer.................................................5-35 CHAPTER 6: CALIBRATION 1. INTRODUCTION ................................................................ 6-1 1.1 Calibration .................................................................. 6-1 1.2 Calibrator Calibration Program .......................................... 6-1 2. PREPARATION FOR CALIBRATION....................................... 6-2 2.1 Precision Check ............................................................ 6-2 2.2 Precision Check Sample .................................................. 6-2 2.3 HGB/HCT Calibration Samples ......................................... 6-3 2.4 Reference Values .......................................................... 6-3 2.4.1 Calibrator Calibration ............................................. 6-3 2.4.2 HGB/HCT Calibration ............................................ 6-3 2.5 Calibration Flow Chart.................................................... 6-4 3. AUTOMATIC CALIBRATION ................................................ 6-5 3.1 Executing Automatic Calibration Program............................. 6-5 3.2 Automatic Calibration Procedure........................................ 6-6 4. MANUAL CALIBRATION....................................................6-11 4.1 Calculating Calibration Value...........................................6-11 4.2 Manual Calibration Procedure ..........................................6-12 5. CALIBRATOR CALIBRATION..............................................6-15 5.1 Executing Calibrator Calibration Program ............................6-15 5.2 Calibrator Calibration Procedure .......................................6-17 6. CALIBRATION HISTORY PRINT...........................................6-25
  • 14. iv Sysmex KX-21N Operator’s Manual -- Revised June 2001 CHAPTER 7: TROUBLESHOOTING 1. INTRODUCTION...................................................................................... 7-1 2. WHEN YOU SUSPECT A TROUBLE..................................................... 7-2 2.1 Alphabetical List of Error Messages Displayed on Analysis Screen.......................................................... 7-3 2.2 Alphabetical List of Error Messages Displayed on HELP Screen... 7-4 2.3 Functional List of Error Messages ................................................... 7-5 3. TROUBLESHOOTING GUIDE................................................................ 7-7 3.1 Pressure/Vacuum Errors................................................................... 7-7 3.2 Chamber Errors .............................................................................. 7-10 3.3 Motor Errors................................................................................... 7-13 3.4 Transducer Errors........................................................................... 7-15 3.5 Temperature Errors......................................................................... 7-16 3.6 Analysis Errors............................................................................... 7-17 3.7 Memory Errors............................................................................... 7-23 3.8 Others ............................................................................................. 7-25 3.9 Maintenance Errors ........................................................................ 7-27 3.10 Printer Errors.................................................................................. 7-30 3.11 External Device Errors................................................................... 7-33 4. STATUS DISPLAY................................................................................. 7-34 5. ERROR HISTORY PRINT...................................................................... 7-36 6. PROGRAM VERSION............................................................................ 7-37 CHAPTER 8: ADJUSTMENT 1. INTRODUCTION.......................................................................................8-1 2. ADJUSTMENT OF PRESSURE AND VACUUM ...................................8-2 2.1 Location of Control Knobs................................................................8-2 2.2 Pressure and Vacuum Display...........................................................8-3 2.3 Adjusting Pressure to 0.05 MPa........................................................8-5 2.4 Adjusting Vacuum to 0.0333 MPa....................................................8-6
  • 15. Sysmex KX-21N Operator’s Manual -- October 1999 v CHAPTER 9: FUNCTIONAL DESCRIPTION 1. INTRODUCTION...................................................................................... 9-1 2. DETECTION PRINCIPLE......................................................................... 9-2 2.1 DC Detection Method ....................................................................... 9-2 2.2 Non-Cyanide Hemoglobin Analysis Method.................................... 9-2 3. MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM...... 9-4 4. CBC ANALYSIS........................................................................................ 9-5 4.1 WBC/HGB Analysis Flow................................................................ 9-5 4.2 RBC/PLT Analysis Flow................................................................... 9-7 4.3 Calculation of RBC Constant............................................................ 9-9 5. BLOOD CELL DISCRIMINATION CIRCUIT...................................... 9-10 5.1 WBC Discriminator......................................................................... 9-10 5.2 RBC Discriminator.......................................................................... 9-10 5.3 PLT Discriminator........................................................................... 9-10 6. ANALYSIS OF HISTOGRAM................................................................ 9-11 6.1 Analysis of WBC Histogram........................................................... 9-11 6.2 Analysis of RBC/PLT Histogram.................................................... 9-20 7. ELECTRIC SYSTEM .............................................................................. 9-28 8. NAMES AND FUNCTIONS OF INSTRUMENTS................................ 9-30 8.1 Front Panel ...................................................................................... 9-30 8.2 Front Interior ................................................................................... 9-31 8.3 Right Side Panel.............................................................................. 9-32 8.4 Left Side Panel ................................................................................ 9-33 8.5 Left Side Interior............................................................................. 9-34 8.6 Rear Panel........................................................................................ 9-35 CHAPTER 10: INSTRUMENT SETUP 1. INTRODUCTION.................................................................................... 10-1 2. SYSTEM SETUP ..................................................................................... 10-3 3. DATE/TIME SETTINGS......................................................................... 10-8 4. PATIENT LIMIT.................................................................................... 10-11 5. QC SETTINGS....................................................................................... 10-14 6. HOST SETTINGS.................................................................................. 10-17 7. PRINTER SETTINGS............................................................................ 10-22 7.1 DP Output Settings........................................................................ 10-23 7.2 GP/LP Output Settings.................................................................. 10-25 7.3 IP Output Settings ......................................................................... 10-27 8. ID READER SETTINGS....................................................................... 10-30 9. PASSWORD SETTINGS....................................................................... 10-32 10. PRINT SET VALUES............................................................................ 10-35 11. PERIPHERAL SETTINGS.................................................................... 10-36 12. FACTORY SETTINGS.......................................................................... 10-38
  • 16. vi Sysmex KX-21N Operator’s Manual -- Revised June 2001 APPENDIX A: INSTALLATION 1. INTRODUCTION......................................................................................A-1 2. CHECK BEFORE INSTALLATION ........................................................A-2 3. INSTALLATION SPACE..........................................................................A-3 4. REMOVE SHIPPING CLAMPS ...............................................................A-4 5. CONNECT TUBE......................................................................................A-6 5.1 Prepare Reagent.................................................................................A-6 5.2 Connect CELLPACK........................................................................A-6 5.3 Connect STROMATOLYSER-WH..................................................A-8 5.4 Connect Waste Line ..........................................................................A-9 6. SET PRINTER PAPER............................................................................A-10 7. CONNECT POWER CORD AND CONNECTING CABLES ...............A-12 7.1 Connect Host Computer, Printer, and Hand Held Barcode Reader A-12 7.2 Connect Power Cord .......................................................................A-12 8. TURN POWER ON..................................................................................A-13 9. REINSTALLING THE PROGRAM........................................................A-13 APPENDIX B: TECHNICAL INFORMATION 1. OUTPUT FORMAT FOR HOST COMPUTER........................................B-1 1.1 HARDWARE....................................................................................B-1 1.2 SOFTWARE .....................................................................................B-3 2. HAND HELD BAR CODE READER SPECIFICATIONS....................B-15 INDEX
  • 17. Sysmex KX-21N Operator’s Manual -- October 1999 CHAPTER 1 INTRODUCTION 1. INTRODUCTION ................................................................. 1-1 2. OVERVIEW OF INSTRUMENT................................................ 1-2 3. OPTION UNITS................................................................... 1-3 4. OUTLINE OF OPERATION..................................................... 1-4 5. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT................ 1-4 6. ANALYSIS PARAMETERS..................................................... 1-5 7. PANEL KEYBOARD ............................................................. 1-7 8. GRAPHIC SCREEN.............................................................. 1-8 8.1 Contents of Display......................................................... 1-8 8.2 Status Display Messages ................................................... 1-9 8.3 LCD Brightness Adjustment..............................................1-12 9. EMERGENCY STOP PROCEDURE..........................................1-12 10. ALARM SOUNDS ...............................................................1-13 11. CONTENTS OF PACKAGE....................................................1-13 12. INSTALLATION ENVIRONMENT...........................................1-14 12.1 Installation and Relocation ................................................1-14 12.2 Grounding ................................................................. .1-14 12.3 Installation Space...........................................................1-15 12.4 Installation Environment ..................................................1-16 13. INSTRUMENT SPECIFICATIONS...........................................1-17 14. MENU TREE......................................................................1-20
  • 18. INTRODUCTION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 1-1 1 . INTRODUCTION The Sysmex® KX-21N is an automatic multi-parameter blood cell counter for in vitro diagnostic use in clinical laboratories. The KX-21N processes approximately 60 samples an hour and displays on the LCD screen the particle distribution curves of WBC, RBC, and platelets, along with data of 17 parameters, as the analysis results. Chapter 1 introduces the overview of the instrument, analysis procedure, etc. that we recommend you to read before using the KX-21N. The main contents of Chapter 1 are as follows: Overview of Instrument The important functions of the KX-21N and the options for efficient operation are explained. Main Points of Analysis Procedure Explanation is given on the procedure for implementing each analysis mode, descriptions and functions of the keys on panel keyboard, and the messages on the LCD screen. Precautions at Time of Installation Explanation is given on the matters that need to be confirmed before installation, such as installation space, required equipment, environmental conditions. Instrument Specifications The instrument specifications are described. Menu Tree This chapter describes the KX-21N menu tree and the corresponding chapters which explain the usage of the menus. Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
  • 19. INTRODUCTION 1-2 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2 . OVERVIEW OF INSTRUMENT The KX-21N performs speedy and accurate analysis of 17 parameters in blood and detects the abnormal samples. To assure easy sorting of abnormal samples in the laboratory, the instrument displays abnormal analysis data with abnormal marks attached on the LCD screen. Thus displayed analysis data allows detecting those samples which are outside the tolerance and need further analysis and reconsideration. The KX-21N employs three detector blocks and two kinds of reagents for blood analysis. The WBC count is measured by the WBC detector block using the DC detection method. The RBC count and platelets are taken by the RBC detector block, also using the DC detection method. The HGB detector block measures the hemoglobin concentration using the non-cyanide hemoglobin method. Figure 1-2-1: Overview of KX-21N Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
  • 20. INTRODUCTION Sysmex KX-21N Operator’s Manual -- October 1999 1-3 3 . OPTION UNITS This instrument offers several option units to ensure its efficient operation. The options that can be used with the KX-21N are: • Graphic Printer: Prints the analysis data obtained from the KX-21N on letter or A4-size paper. • Data Printer: Prints the analysis data obtained from the KX-21N onto a ticket format. DP-510: 943-0571-9 (N.America, 117 V) 943-0581-6 (Europe, 220 V) 943-0591-3 (U.K., 240 V) Figure 1-3-1: Data Printer • Hand Held Barcode Reader: During analysis, reads the barcode that are affixed to the tubes, and automatically sets the sample ID numbers. Figure 1-3-2: Hand Held Barcode Reader Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 21. INTRODUCTION 1-4 Sysmex KX-21N Operator’s Manual -- October 1999 4 . OUTLINE OF OPERATION Two analysis modes are available with the KX-21N: whole blood mode and pre-diluted mode. Analysis procedures in these modes are listed below. Whole blood mode Pre-diluted mode Check before turning ON the power. Turn ON the power. • Self-check • Background check Ready Select whole blood mode. Select pre-diluted mode. Set sample No. Prepare analysis samples in pre-diluted mode (1:26 dilution). Set sample No. Set sample to the sample probe. Press the start switch. • Execute analysis. • End analysis. Ready Check after analysis. Execute shutdown. Turn off the power. Table 1-4-1: Outline of Operation • The work by an operator is shown in shaded cells. • : "Ready" is displayed on the LCD screen. In this state, various operations including analysis, settings, and data processing can be performed. 5 . AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT The KX-21N, when left non-operating for 15 minutes, automatically stops the pneumatic unit. This function saves power consumption and extends component service life. In addition, with this function, analysis-ready status can be resumed faster than by turning on the power. It is also possible to manually stop the pneumatic unit through the Select Menu screen. Pressing the Start switch, the instrument will return to “Ready” status. Ready Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 22. INTRODUCTION Sysmex KX-21N Operator’s Manual -- October 1999 1-5 6 . ANALYSIS PARAMETERS This instrument analyzes the following parameters using three detector blocks and two kinds of reagents: 1) WBC (white blood cell) (Analysis principle: DC detection method) WBC count in 1 µL of whole blood 2) LYM% [W-SCR] (WBC-Small Cell Ratio) Ratio (%) of lymphocytes (small cells) to whole WBC 3) MXD% [W-MCR] (WBC-Middle Cell Ratio) Ratio (%) of the summation of basophils, eosinophils and monocytes (middle cells) to whole WBC 4) NEUT% [W-LCR] (WBC-Large Cell Ratio) Ratio (%) of neutrophils (large cells) to whole WBC 5) LYM# [W-SCC] (WBC-Small Cell Count) Absolute count of lymphocytes (small cells) in 1 µL of whole blood 6) MXD# [W-MCC] (WBC-Middle Cell Count) Absolute count of the basophils, eosinophils and monocytes (middle cells) in 1 µL of whole blood 7) NEUT# [W-LCC] (WBC-Large Cell Count) Absolute count of neutrophils (large cells) in 1 µL of whole blood 8) RBC (red blood cell) (Analysis principle: DC detection method) RBC count in 1 µL of whole blood 9) HGB (Hemoglobin) (Analysis principle: Non-Cyanide hemoglobin analysis method) Volume (gram) of hemoglobin in 1 dL of whole blood 10) HCT (Hematocrit value) (Analysis principle: RBC pulse height detection method) Ratio (%) of whole RBC volume in whole blood 11) MCV (Mean RBC volume) Mean RBC volume (fL) in whole blood, which is calculated by 10 × Hct (%)/ RBC (× 106 /µL). 12) MCH (Mean RBC hemoglobin) Mean hemoglobin volume (pg) per RBC, which is calculated by 10 × Hgb (g/dL)/ RBC (× 106 /µL). 13) MCHC (Mean RBC hemoglobin concentration) Mean hemoglobin concentration (g/dL), which is calculated by 100 × Hgb (g/dL)/ Hct (%). Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 23. INTRODUCTION 1-6 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 14) RDW-CV (RBC distribution width - CV) RBC distribution width (%) calculated from the points defining 68.26% of the entire area spreading from the peak of the RBC particle distribution curve. 15) RDW-SD (RBC distribution width - SD) The distribution width (fL) at the height of 20% from the bottom when the peak RBC particle distribution curve is taken as 100%. 16) PLT (Platelet) (Analysis principle: DC detection method) Platelet count in 1 µL of whole blood 17) MPV (Mean platelet volume) Mean volume of platelet (fL) NOTE: • When analyzing in the pre-diluted mode, only the CBC8 parameters are output. Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
  • 24. INTRODUCTION Sysmex KX-21N Operator’s Manual -- October 1999 1-7 7 . PANEL KEYBOARD The KX-21N is provided with the 22-key panel keyboard. 7 8 9 4 5 6 1 2 3 0 -/. C SAMPLE No. ENTER SELECT MODE HELP SHUTDOWN Figure 1-7-1: Panel Keyboard Name Function SAMPLE No. Used to set a sample No. ENTER Used to fix a sample No., selected menu, etc. SELECT Used to select a menu. Press this key to display the Select Menu screen. When you press it while the Select Menu screen is displayed, the Analysis screen returns. MODE Used to changeover analysis mode (whole blood mode/pre-diluted mode). HELP Used when an error has occurred. SHUTDOWN Used to execute shutdown program. 0 - 9 Used to enter numerics such as a sample No. and set value. −/. Used to enter "−" (hyphen) of a sample No., the decimal point of a set value. C Used to delete characters when entering numerics, and stop the alarm. , Used to select a menu. Each time a key is pressed, the cursor moves to the previous or the next item. , Used to select conditions when setting, and to select Manual Discriminator. Table 1-7-1: Functions of Panel Keyboard CAUTION: • When the alarm is sounding after an error, etc. occurred, press [C] key to stop it or press [HELP] key to display the HELP screen. By pressing [HELP] key, the alarm stops and the HELP screen appears. While the alarm is sounding, the keys other than [C] key and [HELP] key cannot be used.
  • 25. INTRODUCTION 1-8 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 8 . GRAPHIC SCREEN 8.1 Contents of Display 31/12 10:20No.0 WB No.1 PLT 0 P-LCR 0.0 MCHC 0.0 MPV 0.0 MCH 0.0 PDW 0.0 MCV 0.0 RDW-CV 0.0 HCT 0.0 RDW-SD 0.0 HGB 0.0 NEUT% 0.0 0.0 RBC 0.00 MXD% 0.0 0.0 WBC 0.0 LYM% 0.0 0.0 1:M.Discri. 2:Output Ready Next Sample No. Analysis Progress StatusStatus Display Sample Analysis Mode Menu Display Area Analysis Result Display Area Figure 1-8-1: Graphic LCD Name Contents of Display Next Sample No. Displays the sample No. to be analyzed next. Sample Analysis Mode Displays the analysis mode for the sample. : whole blood mode : pre-diluted mode Analysis Progress Status With the start-to-end analysis progress classified into six steps, the present progress status is displayed. Status Display Status of the unit is displayed. Menu Display Area Useable menus for each screen are displayed. Analysis Result Display Area The area for displaying analysis result Table 1-8-1: Contents of Display Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
  • 26. INTRODUCTION Sysmex KX-21N Operator’s Manual -- October 1999 1-9 8.2 Status Display Messages The KX-21N displays instrument status message on the LCD screen. This section gives the meanings of status messages displayed on the LCD screen. Display Message Meaning Sysmex KX-21N [00-01] Please wait. The instrument is making self-check. When the power is turned ON, the instrument checks itself automatically. When the power is turned ON, [00-01] appears briefly in the right lower corner, which indicates the version of the unit control program. *Auto Rinse* Please wait. The hydraulic system is undergoing Auto Rinse. When the power is turned ON, the instrument starts self-check and motor check, followed by auto rinse of the hydraulic system. Auto rinse is also performed when "5: Auto Rinse" in the Select menu is executed and when [SHUTDOWN] key is pressed. When an automatic background check shows a background count exceeding the permissible background count level, rinse sequence is automatically extended.
  • 27. INTRODUCTION 1-10 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. Display Message Meaning 31/12 10:20No.0 WB No.1 PLT 0 P-LCR 0.0 MCHC 0.0 MPV 0.0 MCH 0.0 PDW 0.0 MCV 0.0 RDW-CV 0.0 HCT 0.0 RDW-SD 0.0 HGB 0.0 NEUT% 0.0 0.0 RBC 0.00 MXD% 0.0 0.0 WBC 0.0 LYM% 0.0 0.0 1:M.Discri. 2:Output Ready The instrument is ready for analysis in the whole blood mode. "No." in the left upper corner indicates the sample No. to be analyzed next. 31/12 10:20No.0 PD No.1 PLT WL+000.0 P-LCR WL+000.0 MCHC WL+000.0 MPV WL+000.0 MCH WL+000.0 PDW WL+000.0 MCV WL+000.0 RDW-CV WL+000.0 HCT WL+000.0 RDW-SD WL+000.0 HGB WL+000.0 NEUT% WL+000.0 +000.0 RBC WL+00.00 MXD% WL+000.0 +000.0 WBC WL+000.0 LYM% WL+000.0 +000.0 Ready 1:M.Discri. 2:Output The instrument is ready for pre-diluted mode analysis. "No." in the left upper corner shows the sample No. to be analyzed next. FILE No.1 QC X1 X2 X Judgement WBC RBC HGB HCT MCV MCH MCHC PLT Ready The instrument is ready for X control. "FILE No. 1" in the left upper corner shows QC file No. FILE No.1 QC Data Judgement WBC RBC HGB HCT MCV MCH MCHC PLT Ready The instrument is ready for L-J control. "FILE No. 1" in the left upper corner shows QC file No.
  • 28. INTRODUCTION Sysmex KX-21N Operator’s Manual -- October 1999 1-11 Display Message Meaning *Change Mode* Please wait. The whole blood mode is turning into the pre- diluted mode, or the pre-diluted mode is turning into the whole blood mode. No.123456789-12345 Aspirating The sample is being aspirated in whole blood mode analysis. No.123456789-12345 Aspirating The sample is being aspirated in pre-diluted mode analysis. No.123456789-12345 Analyzing Samples are being aspirated, diluted, and counted. No.123456789-12345 Rinsing Hydraulic line is being rinsed. No.123456789-12345 Replenish Diluent Not Ready An error occurs, making analysis impossible. (When an error occurs, the error message appears in reversed display in the right upper area of the LCD screen.) No.123456789-12345 PU Sleeping Not Ready When operation has been suspended over 15 minutes, the compressor power is turned OFF and this message is displayed. Press the [START] switch to get ready for analysis. Momentary power failure occurred. When the power is turned off without making shutdown process or when power outage caused the instrument to stop, this message appears when the unit is started next time. * Ready When data is automatically output to the host computer, " * " mark lights up in the right upper corner of the screen.
  • 29. INTRODUCTION 1-12 Sysmex KX-21N Operator’s Manual -- October 1999 8.3 LCD Brightness Adjustment Open the front cover of the instrument. LCD brightness can be adjusted using the brightness adjustment knob under the panel keyboard. Turning to the right dims the light and turning to the left brightens it. DarkLight Figure 1-8-2: Brightness adjustment knob NOTE: • If a key input or an operation has not been performed for a fixed time, the LCD back-light will become slightly dimmer (back-light darkening function). To return the LCD to its original brightness, press any key. 9 . EMERGENCY STOP PROCEDURE When there arises the need to stop the instrument urgently because of power outage, etc., in the laboratory, turn off the instrument power switch.
  • 30. INTRODUCTION Sysmex KX-21N Operator’s Manual -- October 1999 1-13 10. ALARM SOUNDS The KX-21N indicates different situations by five kinds of alarm sounds: 1. Key sound (single beep) Sounds about 0.1 second when a key on the panel keyboard is pressed. 2. Input error sound (short beep) Sounds about 1 second when a wrong key is pressed on the panel keyboard. 3. Analysis error sound (long beep) Sounds when an error occurs in the instrument and continues until you press [C] key or [HELP] key on the panel keyboard. 4. Sound at sample aspiration Usually: A single "beep" when the start switch is pressed; "beep, beep" when aspiration is finished. Sample No. "0" or in pre-diluted mode: Beep sounds (beep, beep, ...) continue from pressing the start switch until aspiration ends. 11. CONTENTS OF PACKAGE The instrument is fully inspected before leaving the factory and carefully packed to withstand shocks in transit. Upon arrival, check the package to see that there is no external damage. Sysmex service representative will unpack, install the instrument, and make initial settings. To confirm the contents of the package, refer to "Appendix A: Installation."
  • 31. INTRODUCTION 1-14 Sysmex KX-21N Operator’s Manual -- October 1999 12. INSTALLATION ENVIRONMENT 12.1 Installation and Relocation The KX-21N is installed by Sysmex Service representative. In case relocation becomes necessary after installation, contact your Sysmex service representative. Pay careful attention to this because if relocation, etc. of the instrument should be conducted by the customer, resulting in any trouble, warranty would not be applied even in the warranty period. 12.2 Grounding The instrument power supply cord uses the 3-prong plug. When the power supply socket is 3-prong with grounding, simply plug it to the socket. 117 VAC Spec. 220 VAC Spec. 240 VAC Spec. Figure 1-12-1: Plugs • Make sure to ground the instrument. Inadequate grounding could cause electrical shocks. NOTE: • The number of power supply sockets required is 3 including optional Graphic Printer and optional Data Printer. WARNING
  • 32. INTRODUCTION Sysmex KX-21N Operator’s Manual -- October 1999 1-15 12.3 Installation Space To ensure that the instrument fulfills its function, it is important to install it at an appropriate place: • Choose a place that is close to the power supply and proper waterway. • Secure a place spacious enough for maintenance and service. Giving consideration to heat radiation by the instrument, provide at least 50 cm distance from the wall to side, rear, and top panels. You may need some more desktop space if optional Graphic Printer and Data Printer are provided. • Choose a place where reagent is easy to handle. The instrument dimensions are shown below. The power supply cord is 1.8 m long, the waste tube up to 6 m long, and the diluent (CELLPACK) tube up to 2 m long. Width (mm) Depth (mm) Height (mm) Weight (kg) Main Unit 420 355 480 30 Table 1-12-1: Instrument Dimensions 480 355 420 Figure 1-12-2: Instrument Dimensions CAUTION: • When the diluent (CELLPACK) tube is more than 2 m long, it may be impossible to have reagent aspirated. Avoid setting CELLPACK at a level higher than the instrument; otherwise, reagent may flow into the vacuum line, possibly damaging the instrument.
  • 33. INTRODUCTION 1-16 Sysmex KX-21N Operator’s Manual -- October 1999 12.4 Installation Environment • Use the instrument at an ambient temperature of 15°C - 30°C (optimum: 23°C). • Use it at a relative humidity range of 30% - 85%. • When air conditioning is used, the maximum cooling capacity of about 172 kcal/hour is required to offset the heat from the instrument. • Avoid a place that can become extremely hot or cold. • Avoid a place that can be exposed to direct sunlight. • Choose a well-ventilated place. • Avoid a place close to a wireless telegraph or communication facility where high frequency waves can be generated or radio interference can occur.
  • 34. INTRODUCTION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 1-17 13. INSTRUMENT SPECIFICATIONS Analysis parameters: WBC (White Bloodcell Count), RBC (Red Bloodcell Count), HGB (hemoglobin), HCT (hematocrit), MCV (mean corpuscular volume), MCH (mean corpuscular hemoglobin), MCHC (mean corpuscular hemoglobin concentration), PLT (platelet), RDW-SD (RBC distribution width-standard deviation), RDW-CV (RBC distribution width-coefficient of variation), MPV (mean platelet volume), LYM% (W-SCR), MXD% (W-MCR), NEUT% (W-LCR), LYM# (W-SCC), MXD# (W-MCC), NEUT# (W-LCC) However, the parameters in pre-diluted mode are eight: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT. Display range WBC 0.0 - 299.9 (×103 /µL) RBC 0.00 - 19.99 (×106 /µL) HGB 0 - 25.0 (g/dL) PLT 0 - 1999 (×103 /µL) Reagent Diluent: CELLPACK WBC/HGB lyse reagent: STROMATOLYSER-WH Detergent CELLCLEAN Consumption of reagent (per sample) Diluent (CELLPACK): Approx. 30 mL WBC/HGB lyse reagent (STROMATOLYSER-WH): Approx. 1.0 mL Throughput Approx. 60 samples/hour Analysis principle WBC: DC detection method RBC: DC detection method HGB: Non-cyanide hemoglobin analysis method
  • 35. INTRODUCTION 1-18 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. Reproducibility Reproducibility is within the following range at the reliability level of 95%. 1) Whole blood mode WBC (4.0 × 103 /µL or over) 3.5% or less RBC (4.00 × 106 /µL or over) 2.0% or less HGB 1.5% or less HCT 2.0% or less MCV 2.0% or less MCH 2.0% or less MCHC 2.0% or less PLT (100 × 103 /µL or over) 6.0% or less LYM# (W-SCC) 15.0% or less MXD# (W-MCC) (1.0 × 103 /µL or over) 30.0% or less NEUT# (W-LCC) 15.0% or less LYM% (W-SCR) 15.0% or less MXD% (W-MCR) (12% or over) 30.0% or less NEUT% (W-LCR) 15.0% or less RDW-SD or RDW-CV 4.0% or less MPV 5.0% or less 2) Pre-diluted mode WBC (4.0 × 103 /µL or over) 6.0% or less RBC (4.00 × 106 /µL or over) 3.0% or less HGB 2.5% or less HCT 3.0% or less MCV 3.0% or less MCH 3.0% or less MCHC 3.0% or less PLT (100 × 103 /µL or over) 9.0% or less Accuracy 1) Whole blood mode WBC: ±3% or ±0.2 × 103 /µL RBC: ±2% or ±0.03 × 106 /µL PLT: ±5% or ±10 × 103 /µL 2) Pre-diluted mode WBC: ±5% or ±0.3 × 103 /µL RBC: ±3% or ±0.05 × 106 /µL PLT: ±8% or ±15 × 103 /µL Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.
  • 36. INTRODUCTION Sysmex KX-21N Operator’s Manual -- October 1999 1-19 Linearity 1) Whole blood mode WBC: 1.0 - 9.9 (× 103 /µL) ±0.3 (× 103 /µL) 10.0 - 99.9 (× 103 /µL) ±3% RBC: 0.30 - 0.99 (× 106 /µL) ±0.03 (× 106 /µL) 1.00 - 7.00 (× 106 /µL) ±3% HGB: 0.1 - 10.0 (g/dL) ±0.2 (g/dL) 10.0 - 25.0 (g/dL) ±2% HCT: 10.0 - 33.3 (HCT%) ±1.0 (HCT%) 33.4 - 60.0 (HCT%) ±3% PLT: 10 - 199 (× 103 /µL) ±10 (× 103 /µL) 200 - 999 (× 103 /µL) ±5% (However, RBC < 7.00 × 106 /µL) Carryover WBC: 3% or less RBC: 1.5% or less HGB: 1.5% or less HCT: 1.5% or less PLT: 5% or less Blood volume aspirated Whole blood mode: Approx. 50 µL Pre-diluted mode: Approx. 200 µL (Diluted blood sample) Blood volume required for the pre-dilution is 20 µL or over. Power supply 117/220/230/240 VAC ± 10% (50/60 Hz) Power consumption Approx. 230 VA or less Heat Compensation Required Approx. 785 BTU/h (198 kcal/h) Dimensions Main Unit: 420 (W) × 355 (D) × 480 (H) mm Weight Main Unit: Approx. 30.0 kg Protection Type Class I Equipment EMC (Electro-magnetic compatibility) This equipment is in conformity to the following IEC (EN) standard. IEC 61326-1: 97+A1: 98 (EN 61326: 97+A1) Electrical equipment for measurement, control and laboratory use -EMC requirements- -EMI (Class A) -EMS (Minimum Immunity test requirements) Sysmex KX-21N Operator’s Manual -- Revised August 2001
  • 37. INTRODUCTION 1-20 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 14. MENU TREE * * * * * * *: If set, password has to be entered. SELECT SAMPLE No. MODE HELP SHUTDOWN 1: Stored Data Chapter 4 Ana. Screen 4: Replace Lyse 3: Calibration 8: Periph. Settings 7: Maintenance 2: Clean Transducer 3: Reset SRV Counter 4: Drain TD Chamber 5: Status Display 6: Error History 7: Program Maintenance 1: HGB 2: HGB/HCT 3: HCT 1: M. Discri. 2: Output Chapter 3, 2.2 Chapter 3, 3.3 Chapter 3, 3.4 Chapter 3 Chapter 5, 2 Chapter 5, 2.5 Chapter 5, 2.4 Chapter 6, 2 Chapter 6, 3 Chapter 3, 2.3 Chapter 4, 8.1 Chapter 4, 7.1 Chapter 3 Chapter 5 Chapter 6 Chapter 10 Chapter 10, 2 Chapter 10, 3 Chapter 10, 4 Chapter 10, 5 Chapter 10, 6 Chapter 10, 7 Chapter 10, 8 Chapter 10, 9 Chapter 10,10 Chapter 4, 5.1 Chapter 4, 5.2 Chapter 4, 6.2 Chapter 4, 7.3 Chapter 7, 4 Chapter 7, 5 Chapter 7, 6 Chapter 6, 2 Chapter 6, 2 Chapter 6, 2 1: System Setup 2: Date/Time 3: Patient Limit 4: QC Settings 5: Host Settings 6: Printer Settings 7: ID Reader Settings 8: Password Settings 9: Print Set Values Chapter 10, 9 00: PU Sleep Chapter 2, 6 Chapter 2, 4 Chapter 2, 4 Chapter 2, 6 Chapter 7, 1 2: Output 3: Chg. Disp. 1: Delete 1: QC Analyze 3: Erase All 2: Settings 6: Settings 1: Auto Cal. 2: Manual Cal. Chapter 63: Calibrator Chapter 6, 44: Print Rev. History 5: Auto Rinse 1: Clean W. Chamber 2: Quality Control Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
  • 38. Sysmex KX-21N Operator’s Manual -- October 1999 CHAPTER 2 SAMPLE ANALYSIS 1. INTRODUCTION ................................................................. 2-1 1.1 Overview of Analysis Modes.............................................. 2-1 1.2 Analysis Procedure Flow Chart ........................................... 2-2 2. START-UP PROCEDURE....................................................... 2-3 2.2 Inspection before Turning ON the Power................................ 2-3 2.2 Turning ON the Power and Self-Check ................................. . 2-5 3. QUALITY CONTROL ............................................................ 2-8 4. PROCEDURES IN EACH ANALYSIS MODE ............................... 2-9 4.1 Whole Blood (WB) Mode.................................................. 2-9 4.2 Pre-Diluted (PD) Mode....................................................2-16 5. DISPLAY AND PRINTING OF ANALYSIS RESULT ....................2-24 5.1 Display of Analysis Result................................................2-24 5.2 Printing of Analysis Result ...............................................2-26 5.3 Output of Analysis Result to Host Computer...........................2-27 6. LIMITATIONS....................................................................2-28 6.1 Cell Count Parameters.....................................................2-28 6.2 Limitation of Hemoglobin.................................................2-29 7. EXPECTED RESULTS..........................................................2-30 8. STOPPING THE PNEUMATIC UNIT .......................................2-31 9. EXECUTION OF SHUTDOWN ...............................................2-32 9.1 Shutdown Procedure ......................................................2-32
  • 39. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-1 1 . INTRODUCTION This instrument works in two analysis modes: whole blood mode and pre-diluted mode. This chapter describes the general operation procedures from instrument start-up to shutdown, with the procedures in respective analysis modes. 1.1 Overview of Analysis Modes • Whole blood mode This is the mode of analyzing collected blood sample in the whole blood status. The tube cap is opened and the sample is aspirated through the sample probe one after another. • Pre-diluted mode This mode is used in analyzing a minute amount of child's blood, for instance, collected from the earlobe or fingertip. In this mode, blood sample diluted into 1:26 before analysis is used. The sample aspiration procedure is the same as in the whole blood mode. NOTE: • In the pre-diluted mode, particle distribution curve and particle distribution analysis data are not output, and the output is confined to only the CBC8 parameter.
  • 40. SAMPLE ANALYSIS 2-2 Sysmex KX-21N Operator’s Manual -- October 1999 1.2 Analysis Procedure Flow Chart Shown below is the Flow Chart for the operation procedure with pages to refer to. Inspection before Turning ON the Power Turning ON the Power and Self-Check Execution of Quality Control Display and Printing of Analysis Result Execution of Shutdown Turning OFF the Power Page 2-3 Page 2-5 Page 2-8 Whole Blood Mode Analysis Pre-Diluted Mode Analysis Page 2-16Page 2-9 Page 2-24 Page 2-32 Table 2-1-1: Analysis Procedure Flow Chart
  • 41. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-3 2 . START-UP PROCEDURE 2.1 Inspection before Turning ON the Power 1 . Inspection of reagents Check to see that the reagents needed for the number of the samples to be processed for the day are available. If the number available is such as might become short during the day, make ready the reagents for use in replenishment. When reagents run out during analysis, the instrument will automatically come to a stop. Replenish the reagent that gave an error. Until replenishment is completed, analysis cannot be resumed. The number of samples that can be analyzed with one pack of reagent is listed below: • Number of the samples that can be analyzed with one pack of reagent CELLPACK: Approx. 600 samples/20 L (cubitainer) STROMATOLYSER-WH: Approx. 470 samples/500 mL (bottle) (The above values are the result of continuous analyses performed in one day in the whole blood mode. Depending on the use conditions of the instrument, the result may differ.) • Replenishing reagent • Make ready a new reagent and make sure that it has not passed its expiration date. (For detail, refer to Chapter 4, Section 8: SUPPLIES REPLACEMENT.) • Use a reagent that has been left at room temperature (15 - 30°C) for more than 24 hours. • If CELLPACK that has just arrived is used, "Background Error" may occur. • After replenishing a reagent, make sure that its background count is low before starting sample analysis. • As to a reagent that may have frozen, handle it in accordance with the precautions stated on the Package Insert. Otherwise, there is a possibility that proper analysis cannot be performed. • When replacing the reagent container, take care not to have dust adhere to the cubitainer spout kit. • After unpacking, take care to prevent entry of dust, dirt, bacteria, etc. which could impair proper analysis. CELLPACK 20 L STROMATOLYSER-WH 500 mL 60 days 90 days Table 2-2-1: Expiration After Opening the Seal CAUTION
  • 42. SAMPLE ANALYSIS 2-4 Sysmex KX-21N Operator’s Manual -- October 1999 • We recommend preparing "Reagent Replenishment Record" in which to enter date of replenishment, name of reagent, reagent lot No., expiration date, name of person who replenished. Such record would come handy. 2 . Inspection of the instrument Inspect the connection of tubings and cords to see that there are no broken tubes and the power cord is properly plugged in the outlet. 3 . Inspection of waste If waste is found to have collected in the trap chamber on the left side of the unit and the waste tank (when provided), discard the waste. 4 . Inspection of printer paper Open the front cover and check if printer paper needed for processing the samples for the day is available. Figure 2-2-1: Inspection of Printer Paper (Built-in Printer) CAUTION: • Use the printer paper specified by Sysmex. Avoid using print paper that has its end fixed to the core. Such paper can cause failure.
  • 43. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-5 2.2 Turning ON the Power and Self-Check Turn ON the power switch on the right side of the unit. Self-check, auto rinse, and background check will be automatically performed, and the "Ready" (ready for analysis) will appear. 1 . Turn ON the power switch (1) The initial display appears on the LCD screen. The program version (Example: [00- 01]) appears at the right lower area of the screen. Sysmex KX-21N [00-01] Figure 2-2-2: Initial Display (2) Next, the instrument makes self-check of motor operation, scheduled maintenance items, etc. The LCD screen displays "Please wait." during this period. Please wait. Figure 2-2-3: LCD Screen during Self-check
  • 44. SAMPLE ANALYSIS 2-6 Sysmex KX-21N Operator’s Manual -- October 1999 CAUTION: • When self-check reveals any error, an error message will appear on the LCD screen. In this case, turn OFF the power once, then turn it ON again. If the error still occurs, contact Sysmex service representative. • To ensure optimum operation of the instrument, service counters are provided for the components which require scheduled maintenance. If upon the power turn-on, the counter is found exceeding the predetermined times, the screen advising scheduled maintenance is displayed. When the Scheduled Maintenance screen appears, press [C] key to stop the alarm sound, then perform maintenance operation by following the instructions on the screen. For detail, refer to Chapter 4: INSTRUMENT MAINTENANCE AND SUPPLIES REPLACEMENT. (3) When self-check is normally completed, auto rinse and background check are performed. *Auto Rinse* Please wait. Figure 2-2-4: LCD Screen during Auto Rinse NOTE: • Auto rinse is repeated 3 - 5 times. If the background count of any parameter exceeds tolerance after rinsing a maximum of 5 times, the message "Background Error" is displayed and the alarm sounds. In this case, press [HELP] key to stop the alarm and display the Action Message screen. In accordance with the Action Message screen, take an appropriate action. (Refer to Chapter 7: TROUBLESHOOTING.) • Permissible background counts WBC 0.3 [×103 /µL] or less RBC 0.02 [×106 /µL] or less HGB 0.1 [g/dL] or less PLT 10 [×103 /µL] or less
  • 45. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2-7 2 . Confirming the "Ready" When auto rinse and background check are normally completed, the buzzer (single beep) sounds briefly and "Ready" is displayed. The LCD screen displays the result of background check (sample No. "0"). 31/12 10:20No.0 WB No.1 PLT 0 P-LCR 0.0 MCHC 0.0 MPV 0.0 MCH 0.0 PDW 0.0 MCV 0.0 RDW-CV 0.0 HCT 0.0 RDW-SD 0.0 HGB 0.0 NEUT% 0.0 0.0 RBC 0.00 MXD% 0.0 0.0 WBC 0.0 LYM% 0.0 0.0 1:M.Discri. 2:Output Ready Figure 2-2-5: Ready Status NOTE: • When the power is on, the next sample No. is displayed "1."
  • 46. SAMPLE ANALYSIS 2-8 Sysmex KX-21N Operator’s Manual -- October 1999 3 . QUALITY CONTROL Quality control is of great importance for obtaining highly reliable data over a long period of time, as is the constant monitoring of the instrument for preventing troubles or for early detection of problems. Before starting sample analysis, analyze control blood (EIGHTCHECK-3WP) using X control or L-J control program. The analysis mode used in analyzing control blood is described below. • Analysis mode to analyze a control blood Control blood is analyzed in the QC analysis mode. For analysis procedure and examination of analysis result, refer to Chapter 5: QUALITY CONTROL.
  • 47. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-9 4 . PROCEDURES IN EACH ANALYSIS MODE With this instrument, sample mixing, cap removal, and tube setting are performed manually. Sample analysis can be executed when the instrument is in the Ready status. 4.1 Whole Blood (WB) Mode Samples are processed in the following steps: 1. Collecting and preparing samples 2. Selecting whole blood mode 3. Inputting sample No. 4. Analyzing samples 1 . Collecting and preparing samples A specified amount of sample, corresponding to the amount of EDTA anticoagulant, is collected from the vein. • Some anticoagulants alter test results due to their effects on RBC hemolysis or platelet agglutination. As anticoagulant, use EDTA-2K, EDTA-3K, or EDTA-2Na. • In the case of refrigerated blood, leave the blood taken from the refrigerator for 30 minutes until it equilibrated to room temperature. • When the reagent might have frozen, handle it according to the precautions stated on the Package Insert of each reagent. Otherwise, improper analysis may result. Tubes up to 80 mm in height should be used. The volume of sample that can be aspirated is as follows: Volume of sample aspirated Approx. 50 µL CAUTION
  • 48. SAMPLE ANALYSIS 2-10 Sysmex KX-21N Operator’s Manual -- October 1999 2 . Selecting whole blood mode When the line on the side of the system status area on the LCD screen is " ", the pre-diluted (PD) mode is in use for analysis, so change it over to the whole blood (WB) mode by the following procedure: (1) Confirm the Ready status. (2) Press [MODE] key to display the Change Mode screen. *Change Mode* Whole Blood(WB) Pre-Diluted(PD)Pre-Diluted(PD) Change mode with [ ]or[ ]. Press [ENTER] to Set. Figure 2-4-1: Change Mode Screen (3) Press [ ] or [ ] key to select "Whole Blood (WB)." *Change Mode* Whole Blood(WB) Pre-Diluted(PD) Change mode with [ ]or[ ]. Press [ENTER] to Set. Figure 2-4-2: Selecting WB Mode (4) Press [ENTER] key to changeover the analysis mode and return to the Analysis screen. NOTE: • The analysis mode selected here is maintained after completion of analysis, until it is switched to the other analysis mode. • At the time of turning-on the power, the system is in the whole blood mode.
  • 49. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-11 3 . Inputting sample No. The sample No. can be input by the following two methods. • Input from the panel keyboard • Input using the hand held barcode reader (option) NOTE: • The sample number is set by the incremented value for each analysis. Input the sample number when changing. • Input from the panel keyboard (1) Press [SAMPLE No.] key in the Ready status. In the system status area on the LCD screen, the next sample No. turns to the reverse display and the system is waiting for Sample No. input (in the "Not Ready" status). No.123456789012345 Not Ready Figure 2-4-3: Waiting for Sample No. input (2) The cursor appears under sample No. Input sample No. using the numeric keys. [Example] Input of sample No. 5 Press [5] key on the numeric keys. CAUTION: • Sample No. "0" (zero) is treated as a special sample number. 1) Judgment on patient limit is not made for analysis data. 2) Analysis data is not stored. 3) Data is not transferred to the host computer. 4) Sample No. is not incremented. 5) Judgment on abnormal histogram is not made. 6) When one attempts to make analysis with the sample No. of "0" (zero), the buzzer sounds during sample aspiration. NOTE: • When entering the sample No. (on the screen of the previous page), press [C] key first. This will clear the entire sample No. Then, enter a new sample No. • In the course of entering the sample No., each time you press [C] key, one character disappears with the cursor moving to the left. • A sample No. of a maximum of 15 digits, comprising numerics and a hyphen, can be used. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 50. SAMPLE ANALYSIS 2-12 Sysmex KX-21N Operator’s Manual -- October 1999 (3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready, namely, ready for analysis. NOTE: • When all sample Nos. are cleared, [ENTER] key is not accepted. When you attempt to do so, an alarm sounds. • In the status of waiting for sample No. input ("Not Ready"), press [SAMPLE No.] or [SELECT] key. The screen returns to the Analysis screen without updating sample No. • Input using the hand held barcode reader (option) (1) Press [SAMPLE No.] key in the Ready status. In the system status area on the LCD screen, the next sample No. turns to the reverse display and the system is waiting for Sample No. input (in the "Not Ready" status). No.123456789012345 Not Ready Figure 2-4-4: Waiting for Sample No. input (2) Read the barcode affixed to the test tube with the hand held barcode reader. Figure 2-4-5: Reading the Barcode When reading has been carried out normally, the read sample number will appear. (3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready, namely, ready for analysis. NOTE: • In the status of waiting for sample No. input ("Not Ready"), press [SAMPLE No.] or [SELECT] key. The screen returns to the Analysis screen without updating sample No. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 51. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-13 4 . Analyzing samples • When analyzing samples, always wear rubber gloves. After completion of work, wash hands with disinfectant. If your hands are contaminated by blood, etc., infection of bacteria can occur. (1) Mix the sample sufficiently. Figure 2-4-6: Mixing the Sample (2) Remove the plug while taking care not to allow blood scatter. Figure 2-4-7: Removing the Plug (3) Set the tube to the sample probe, and in that condition, press the start switch. Start Switch Figure 2-4-8: Pressing the Start Switch WARNING
  • 52. SAMPLE ANALYSIS 2-14 Sysmex KX-21N Operator’s Manual -- October 1999 (4) The buzzer sounds two times - "beep, beep" - and when the LCD screen displays "Analyzing," remove the tube. After that, the unit executes automatic analysis and displays the result on the LCD screen. Then the unit turns to the Ready status, becoming ready for analysis of the next samples. The screens from the start to the end of analysis are as shown in the following: (Ready) No.123456789-12345 Ready (Aspirating) No.123456789-12345 Aspirating (Analyzing) No.123456789-12345 Analyzing (Rinsing) No.123456789-12345 Rinsing (Ready) No.123456789-12346 Ready Figure 2-4-9: LCD Screen (in WB Mode) • While the LCD screen is displaying "Aspirating," keep holding the tube in the aforementioned status. If the tube is removed during its display, correct analysis result may not be obtained. CAUTION: • Several seconds after the buzzer sounds "beep, beep" and "Aspirating" appears on the LCD screen, the rinse cup lowers. By that time, remove the tube. • To remove the tube, lower it straight down. Take care not to bend the sample probe. NOTE: • The sample probe is automatically rinsed, so there is no need to wipe it clean. CAUTION
  • 53. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-15 (5) When the LCD screen displays "Ready," prepare the next samples and repeat the procedure (1) to (4). NOTE: • Sample No., if not changed, is automatically incremented by 1, although "0" (zero) is not incremented. [Example] 123 → 124 999999999999999 → 1 12-3 → 12-4 12-999 → 12-000
  • 54. SAMPLE ANALYSIS 2-16 Sysmex KX-21N Operator’s Manual -- October 1999 4.2 Pre-Diluted (PD) Mode In this mode, a sample is diluted into 1:26 before analysis. This mode is applied in analyzing a capillary blood collected from the earlobe or fingertip. Samples are processed by the following steps: 1. Collecting and preparing samples 2. Preparing analysis samples in PD mode (dilution of 1:26) 3. Selecting Pre-Diluted mode 4. Inputting sample No. 5. Analyzing samples 1 . Collecting and preparing samples Dilute samples to the ratio of 1:26 using CELLPACK dispensed beforehand in containers. [Example] 20 µL of blood is diluted in 500 µL of CELLPACK. • Dilute and analyze a capillary blood collected from the earlobe or fingertip immediately to avoid possible platelet agglutination. A correct result might not be obtained if 30 minutes are passed after dilution. • With a sample of blood collected from the earlobe or fingertip, blood cell count is generally higher than normal, with lower reproducibility. If possible, analyze the same diluted sample twice and compare the results. When the blood collection tube containing a commercial anti- coagulant is used, there is a possibility that RBC hemolysis or platelet agglutination occurs depending on the types of anticoagulant, with a consequent change in analysis result. As anti-coagulant, use EDTA- 2K, EDTA-3K, or EDTA-2Na. Tubes up to 80 mm in height should be used. The volume of sample is as follows: Volume of whole blood required Approx. 20 µL or more Volume of sample aspirated Approx. 200 µL CAUTION Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 55. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-17 2 . Preparing analysis samples in PD mode (1:26 Dilution) (1) Clean a container such as erlenmeyer flask, beaker, etc. with CELLPACK and remove any dirt. (2) Using a syringe, etc., take CELLPACK into a cleaned container. (3) Using a 500 µL transfer pipette, dispense 500 µL of CELLPACK into a micro-tube. (4) Using a capillary tube, etc., collect 20 µL of blood and dispense it into the micro-tube. (5) Attach the cap and mix well. • When preparing PD-mode analysis samples, always wear rubber gloves. After completion of work, wash hands with disinfectant. If your hands are contaminated by blood, etc., infection of bacteria or the like can occur. • A 1:26 dilution sample is prone to platelet agglutination. So, analyze the sample within 30 minutes after blood dispensing and diluting. If diluent is dispensed in advance, evaporation and dirt mixing will result in errors in analysis values. Therefore prepare one sample at a time. When preparing a 1:26 dilution sample, use the tools listed below: • Diluent (CELLPACK) • Micro-tube (MT-40, etc.) • Capillary tube • A 500 µL transfer pipette • A container, such as erlenmeyer flask or beaker • A syringe WARNING CAUTION
  • 56. SAMPLE ANALYSIS 2-18 Sysmex KX-21N Operator’s Manual -- October 1999 3 . Selecting Pre-Diluted mode When the line on the side of the system status area on the LCD screen is " ", the whole blood (WB) mode is in use for analysis, so change it over to the pre-diluted (PD) mode by the following procedure: (1) Confirm the Ready status. (2) Press [MODE] key to display the Change Mode screen. *Change Mode* Whole Blood(WB) Pre-Diluted(PD) Change mode with [ ]or[ ]. Press [ENTER] to Set. Figure 2-4-10: Change Mode Screen (3) Press [ ] or [ ] key to select "Pre-Diluted (PD)." *Change Mode* Whole Blood(WB) Pre-Diluted(PD)Pre-Diluted(PD) Change mode with [ ]or[ ]. Press [ENTER] to Set. Figure 2-4-11: Selecting PD Mode (4) Press [ENTER] key to changeover the analysis mode and return to the Analysis screen. NOTE: • The analysis mode selected here is maintained after completion of analysis, until it is switched to the other analysis mode. • At the time of turning-on the power, the system is in the whole blood mode.
  • 57. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-19 4 . Inputting sample No. The sample No. can be input by the following two methods. • Input from the panel keyboard • Input using the hand held barcode reader (option) NOTE: • The sample number is set by the incremented value for each analysis. Input the sample number when changing. • Input from the panel keyboard (1) Press [SAMPLE No.] key in the Ready status. The next Sample No. in the system status area on the LCD screen turns to the reverse display and the system waits for Sample No. input (in the "Not Ready" status). No.123456789012345 Not Ready Figure 2-4-12: Waiting for Sample No. input (2) The cursor appears under sample No. Input sample No. using the numeric keys. [Example] Input of Sample No. 5 Press [5] key on the numeric keys. CAUTION: • Sample No. "0" (zero) is treated as a special sample number. 1) Judgment on patient limit is not made for analysis data. 2) Analysis data is not stored. 3) Data is not transferred to the host computer. 4) Sample No. is not incremented. 5) Judgment on abnormal histogram is not made. 6) When one attempts to make analysis with the sample No. of "0" (zero), the buzzer sounds during sample aspiration. NOTE: • When entering the sample No. (on the screen of the previous page), press [C] key first. This will clear the entire sample No. Then, enter a new sample No. • In the course of entering the sample No., each time you press [C] key, one character disappears with the cursor moving to the left. • A sample No. of a maximum of 15 digits, comprising numerics and a hyphen, can be used. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 58. SAMPLE ANALYSIS 2-20 Sysmex KX-21N Operator’s Manual -- October 1999 (3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready, namely, ready for analysis. NOTE: • When all sample Nos. are cleared, [ENTER] key is not accepted. When you attempt to do so, an alarm sounds. • In the status of waiting for sample No. input ("Not Ready"), press [SAMPLE No.] or [SELECT] key. The screen returns to the Analysis screen without updating sample No. • Input using the hand held barcode reader (option) (1) Press [SAMPLE No.] key in the Ready status. In the system status area on the LCD screen, the next sample No. turns to the reverse display and the system is waiting for Sample No. input (in the "Not Ready" status). No.123456789012345 Not Ready Figure 2-4-13: Waiting for Sample No. input (2) Read the barcode affixed to the test tube with the hand held barcode reader. Figure 2-4-14: Reading the Barcode When reading has been carried out normally, the read sample number will appear. (3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready, namely, ready for analysis. NOTE: • In the status of waiting for sample No. input ("Not Ready"), press [SAMPLE No.] or [SELECT] key. The screen returns to the Analysis screen without updating sample No. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 59. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-21 5 . Analyzing samples • When analyzing samples, always wear rubber gloves, and after completion of work, wash hands with disinfectant. If your hands are contaminated by blood, etc., infection of bacteria can occur. (1) Mix the sample sufficiently. Figure 2-4-15: Mixing the Sample (2) Remove the plug while taking care not to allow blood scatter. Figure 2-4-16: Removing the Plug (3) Set the micro-tube to the sample probe, and in that condition, press the start switch. Start Switch Figure 2-4-17: Pressing the Start Switch WARNING
  • 60. SAMPLE ANALYSIS 2-22 Sysmex KX-21N Operator’s Manual -- October 1999 (4) The buzzer sounds two times - "beep, beep" - and when the LCD screen displays "Analyzing," remove the micro-tube. After that, the unit executes automatic analysis and displays the result on the LCD screen. Then the unit turns to the Ready status, becoming ready for analysis of the next samples. The screens from the start to the end of analysis are as shown in the following: (Ready) No.123456789-12345 Ready (Aspirating) No.123456789-12345 Aspirating (Analyzing) No.123456789-12345 Analyzing (Rinsing) No.123456789-12345 Rinsing (Ready) No.123456789-12346 Ready Figure 2-4-18: LCD Screen (in PD Mode) • While the LCD screen is displaying "Aspirating," keep holding the micro-tube in the aforementioned status. If the micro-tube is removed during its display, correct analysis result may not be obtained. CAUTION: • Several seconds after the buzzer sounds "beep, beep" and "Aspirating" appears on the LCD screen, the rinse cup lowers. By that time, remove the micro-tube. • To remove the micro-tube, lower it straight down. Take care not to bend the sample probe. NOTE: • The sample probe is automatically rinsed, so there is no need to wipe it clean. CAUTION
  • 61. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-23 (5) When the LCD screen displays "Ready," prepare a next sample and repeat the procedure (1) to (4). NOTE: • Sample No., if not changed, is automatically incremented by 1, although "0" (zero) is not incremented. [Example] 123 → 124 999999999999999 → 1 12-3 → 12-4 12-999 → 12-000
  • 62. SAMPLE ANALYSIS 2-24 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 5 . DISPLAY AND PRINTING OF ANALYSIS RESULT 5.1 Display of Analysis Result The result of each analysis is displayed on the LCD screen. The display screen of analysis result consists of five pages, and pages are turned over by using [ ] or [ ] key. For the contents of display, refer to Chapter 3, Section 2.1: Display of Analysis Result. Examples of display (For the Whole Blood mode) 31/12 10:59No.123456789-12345 WB No.123456789-12346 PLT 180 P-LCR - 9.5 MCHC + 44.8 MPV 9.3 MCH 37.0 PDW - 7.9 MCV - 82.6 RDW-CV 20.5 HCT 32.8 RDW-SD - 25.6 HGB 14.7 NEUT% 49.2 3.5 RBC 3.97 MXD% 19.6 1.4 WBC 7.1 LYM% 31.2 2.2 31/12 10:59No.123456789-12345 WB No.123456789-12346 PLT 180 ×103 /µL MCHC + 44.8 g/dL MCH 37.0 pg MCV - 82.6 fL HCT 32.8 % HGB 14.7 g/dL RBC 3.97 ×106 /µL WBC 7.1 ×103 /µL 31/12 10:59No.123456789-12345 WB No.123456789-12346 P-LCR - 9.5 % MPV 9.3 fL PDW - 7.9 fL RDW-CV 20.5 % RDW-SD - 25.6 fL NEUT% 49.2 % 3.5 MXD% 19.6 % 1.4 LYM% 31.2 % 2.2 31/12 10:59No.123456789-12345 WB No.123456789-12346 WBC RBC PLT 31/12 10:59No.123456789-12345 WB No.123456789-12346 WBC RBC PLT PLT 180 ×103 /µL MCHC + 44.8 g/dL MCH 37.0 pg MCV - 82.6 fL HCT 32.8 % HGB 14.7 g/dL RBC 3.97 ×106 /µL WBC 7.1 ×103 /µL P-LCR - 9.5 % MPV 9.3 fL PDW - 7.9 fL RDW-CV 20.5 % RDW-SD - 25.6 fL NEUT% 49.2 % 3.5 MXD% 19.6 % 1.4 LYM% 31.2 % 2.2 P1. All Analysis Data Display Screen P2. CBC8 Parameter & Patient Limit Graph Display Screen P3. Calculation Parameter & Patient Limit Graph Display Screen P5. CBC8 Parameter & Particle Distribution Display Screen P4. Calculation Parameter & Particle Distribution Display Screen Ready 1:M.Discri. 2:Output Ready 1:M.Discri. 2:Output Ready 1:M.Discri. 2:Output Ready 1:M.Discri. 2:Output Ready 1:M.Discri. 2:Output Figure 2-5-1: Analysis Result Display Screen
  • 63. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2-25 5.2 Printing of Analysis Result Analysis result can be printed out on the built-in or the external printer. (The external printer is an option) For the contents of the print and the printing procedure, refer to Chapter 3, Section 2.3: External Output. Examples of printing with the Built-in Printer WBC [fL] RBC [fL] PLT [fL] [Type 1] [Type 2] [Type 3] No. 123456789-12345 Date 31/10/1999 Time 10:02 Mode WB [W][R][P] WBC 7.3 ×103 /µL RBC 4.52 ×106 /µL HGB 14.8 g/dL HCT 36.2 % MCV 80.1 fL MCH 32.7 Pg MCHC 40.9 g/dL PLT 206 ×103 /µL LYM% 27.2 % MXD% 13.4 % NEUT% 59.4 % LYM# 2.0 ×103 /µL MXD# 1.0 ×103 /µL NEUT# 4.3 ×103 /µL RDW-SD 8.3 fL RDW-CV 15.0 % PDW 8.3 fL MPV 9.1 fL P-LCR 14.8 % No. 123456789-12345 Date 31/10/1999 Time 10:02 Mode WB [W][R][P] WBC 7.3 ×103 /µL RBC 4.52 ×106 /µL HGB 14.8 g/dL HCT 36.2 % MCV 80.1 fL MCH 32.7 Pg MCHC 40.9 g/dL PLT 206 ×103 /µL LYM% 27.2 % MXD% 13.4 % NEUT% 59.4 % LYM# 2.0 ×103 /µL MXD# 1.0 ×103 /µL NEUT# 4.3 ×103 /µL RDW-SD 8.3 fL RDW-CV 15.0 % PDW 8.3 fL MPV 9.1 fL P-LCR 14.8 % No. 123456789-12345 Date 31/10/1999 Time 10:02 Mode WB [W][R][P] WBC 7.3 ×103 /µL RBC 4.52 ×106 /µL HGB 14.8 g/dL HCT 36.2 % MCV 80.1 fL MCH 32.7 Pg MCHC 40.9 g/dL PLT 206 ×103 /µL Figure 2-5-2: Printing of Analysis Result (Built-in Printer) NOTE: • One print format can be selected from among Types 1, 2, and 3. For the selecting procedure, refer to Chapter 10, Section 7.3: IP Output Settings.
  • 64. SAMPLE ANALYSIS 2-26 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. Examples of printing with the Graphic Printer Sample No.:123456789-12345 31/10/1999 16:40 Mode:WB Manual Ana:[W][R][P] [ERROR] WBC 7.3 [×103 /µL] RBC 4.52 [×106 /µL] HGB 14.8 [g/dL] HCT 36.2 [%] MCV 80.1 [fL] MCH 32.7 [Pg] MCHC 40.9 [g/dL] PLT 206 [×103 /µL] LYM% 27.2 [%] MXD% 13.4 [%] NEUT% 59.4 [%] LYM# 2.0 [×103 /µL] MXD# 1.0 [×103 /µL] NEUT# 4.3 [×103 /µL] RDW-SD 8.3 [fL] RDW-CV 15.0 [%] PDW 8.3 [fL] MPV 9.1 [fL] P-LCR 14.8 [%] PLT RBC WBC Figure 2-5-3: Printing of Analysis Result (Graphic Printer)
  • 65. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2-27 Examples of printing with the Data Printer HEMATOLOGY Doctor Age Data Sample No. WBC ×103/µL RBC ×106/µL HGB g/dL HCT % MCV fL MCH pg MCHC g/dL PLT Myelo- blast ×103/µL W-SCR % W-MCR % W-LCR % W-SCC ×103/µL W-MCC ×103/µL W-LCC ×103/µL RDW-SD fL MPV fL W-SCR WBC-Small Cell Ratio 10/12/1999 123456789012345 Retic Pro Myelo Meta Neutro Stab Seg Eosino Baso Mono Lymph 5.6+ 3.58 8.0 34.1 80.1 M F Carte No. Name PRINT TICKET No.22 W-MCR WBC-Middle Cell Ratio W-LCR WBC-Large Cell Ratio W-SCC WBC-Small Cell Count W-MCC WBC-Middle Cell Count W-LCC WBC-Large Cell Count RDW-CV RBC Distrib. Width-CV PDW PLT Distrib. Width MPV Mean Platelet Vol P-LCR PLT-Large Cell Ratio 32.7 40.9 206 28.3 18.8 52.9 1.6 1.0 3.0 68.5 10.0 Figure 2-5-4: Printing of Analysis Result (Data Printer) 5.3 Output of Analysis Result to Host Computer The analysis result can be output to the host computer. For the output procedure to the host computer, refer to Chapter 3, Section 2.3: External Output.
  • 66. SAMPLE ANALYSIS 2-28 Sysmex KX-21N Operator’s Manual -- October 1999 6 . LIMITATIONS 6.1 Cell Count Parameters Some abnormal samples may give incorrect results by automated cell counting methods. The following table shows examples of specific specimens that could cause errors. Parameter Specimen Error Possible Indication of Error WBC Cold Agglutinin Platelet aggregation Erythroblastosis Nucleated RBC Cryoglobulins (+) (+) (+) (+) (+) ↑MCV, ↓HCT, red cell clumping on smear Platelet aggregates on smear Erythroblasts on smear NRBC on smear RBC Cold Agglutinin Severe Microcytosis Fragmented RBC Leukocytosis (>100,000/µL) (-) (-) (-) (+) ↑MCV, ↓HCT, red cell clumping on smear Elevation of WBC HGB Leukocytosis (>100,000/µL) Lipemia Abnormal Protein (+) (+) (+) Elevation of WBC ↑MCHC, “milky” appearance of plasma ↑MCHC, Lysed Hgb/WBC sample turns cloudy HCT Cold Agglutinin Leukocytosis (>100,000/µL) Abnormal Red Cell Fragility Spherocytosis (-) (+) (?) (?) ↑MCV, ↓HCT, red cell clumping on smear Elevation of WBC ↓MCV, spherocytes on smear PLT Pseudothrombocytopenia Platelet Aggregation Increased Microcytosis Megalocytic Platelets (-) (-) (+) (-) Platelet Satellitism on smear Platelet Aggregation on smear ↓MCV (+): Instrument count is affected by an increase in the result. (-): Instrument count is affected by a decrease in the result. (?): Instrument count is affected by either an increase or decrease in the result which is sample dependent. CAUTION: • WBC results may be elevated erroneously due to unlysed red cells in patients with hemoglobinopathies, severe liver disease or in neonates.
  • 67. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-29 6.2 Limitation of Hemoglobin 1. Hemoglobin measurements may be falsely elevated due to the influences of abnormal samples including leukocytosis above 100,000/µL, lipemia or abnormal proteins in blood plasma. The affect of lipemia and abnormal proteins may be removed by plasma replacement or plasma blank procedures. 2. Performance specifications for hemoglobin results are assured only when instrument environment and sample requirements are observed. 3. The hemoglobin method available for this analyzer cannot detect sulfhemoglobin, verdohemoglobin choleglobin or other unusual degradation products of hemoglobin.
  • 68. SAMPLE ANALYSIS 2-30 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 7 . EXPECTED RESULTS Reference intervals (normal population reference ranges) were developed for the KX-21N using normal individuals. The ranges for each parameter --- WBC, RBC, Hemoglobin, Hematocrit, MCV, MCH, MCHC, RDW-CV, RDW-SD, Platelet, MPV, Lym% and #, Mxd% and #, and Neut% and # were determined and displayed in Table 1-16-1. Parameter Range for Females n=117 Range for Males n = 1 2 4 WBC 3.1 - 10.3 2.6 - 8.8 RBC 3.2 - 4.6 3.6 - 5.3 Hgb 9.9 -13.6 11.3 - 15.7 Hct 30.2 - 42.3 32.6 - 47.5 MCV 78.6 - 102.2 80.3 - 103.4 MCH 25.2 - 34.7 26 - 34.4 MCHC 31.3 - 35.4 31.8 - 36.3 Plt 128 - 434 134 - 377 Lym% 15 - 45.8 17.5 - 47.9 Mxd% 1.3 - 25.9 1.9 - 24.6 Neut% 43.7 - 77.1 38.3 - 69 Lym# 0.9 - 2.8 0.8 - 2.7 Mxd# 0.1 - 1.6 0.1 - 1.5 Neut# 1.6 - 6.9 1.2 - 5.3 RDW-CV 10.6 - 15.7 10.8 - 14.9 RDW-SD 35.3 - 48.9 33.4 - 49.2 MPV 8.5 - 12.4 8.1 - 12.4 Table 2-7-1: Normal Population Reference Ranges NOTE: • The age range for females was 17 - 66 years with a mean age of 33.4. • The age range for males was 17 - 72 years with a mean age of 42.2. Sysmex recommends that each laboratory establish its own expected reference intervals based upon the laboratory’s patient population encountered during daily operation. Expected reference intervals may vary due to differences in sex, age, diet, fluid intake, geographic location, etc. The NCCLS Document C28A1, “How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline”. This document contains guidelines for determining reference values and intervals for quantitative clinical laboratory test. 1 NCCLS, 771 East Lancaster Avenue, Villanova, PA 19085, USA.
  • 69. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-31 8 . STOPPING THE PNEUMATIC UNIT The KX-21N, when left non-operating for 15 minutes, automatically stops the pneumatic unit. It is also possible to manually stop the pneumatic unit using the following procedures: (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Using [ ] key or [ ] key, move the cursor to select "00: PU Sleep." *SELECT* 1:Stored Data 2:Quality Control 3:Calibration 4:Replace Lyse 5:Auto Rinse 6:Settings 7:Maintenance 8:Periph. Settings 00:PU Sleep Figure 2-8-1: Select Menu Screen (3) Press [ENTER] key. This stops the pneumatic unit. NOTE: • Press the start switch to return to the ready status.
  • 70. SAMPLE ANALYSIS 2-32 Sysmex KX-21N Operator’s Manual -- October 1999 9 . EXECUTION OF SHUTDOWN When analyses of all samples are finished, execute shutdown before turning the power off. By executing shutdown, the TD chamber and diluted sample line are cleaned. Execute shutdown after the day's work is finished, and also when this instrument is used continuously, shut it down at least once in 24 hours. CAUTION: • If the power is turned OFF before executing shutdown, failures could occur, such as fluid dripping from the rinse cup and crystals forming around the rinse cup. 9.1 Shutdown Procedure (1) Press [SHUTDOWN] key in the Ready status. The Shutdown screen appears. 3:Cancel *Shutdown* Aspirate CELLCLEAN. It will take approx. 5 minutes. Ready Figure 2-9-1: Shutdown Screen NOTE: • When [3] key is pressed, shutdown is canceled and the Analysis screen returns.
  • 71. SAMPLE ANALYSIS Sysmex KX-21N Operator’s Manual -- October 1999 2-33 (2) When executing shutdown, set CELLCLEAN to the sample probe and press the start switch in that status. While "Aspirating" is being displayed on the screen, keep holding CELLCLEAN in the same status. Start Switch Figure 2-9-2: Pressing the Start Switch • Because CELLCLEAN is a strong alkaline detergent, take care not to have it adhere to the skin or clothes. If the skin or clothes should come in touch with it, flush it away using plenty of water. Otherwise, it can damage the skin or clothes. NOTE: • Once shutdown is executed, it cannot be canceled until it is completed. (3) When the buzzer sounds two times - beep, beep- , informing the completion of aspiration, remove CELLCLEAN from the sample probe. After that, shutdown is executed automatically. *Shutdown* Please wait. Rinsing Figure 2-9-3: Shutdown Execution Screen CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to bend the sample probe. WARNING
  • 72. SAMPLE ANALYSIS 2-34 Sysmex KX-21N Operator’s Manual -- October 1999 (4) When shutdown is finished and the following message is displayed, turn off the power switch on the right side of the unit. 1:Re-boot Shut-down sequence was completed. Turn OFF the power. *Shutdown* Figure 2-9-4: Shutdown Completion Message Screen NOTE: • Shutdown will take approximately 5 minutes. • When the [1] key is pressed, the unit will restart.
  • 73. Sysmex KX-21N Operator’s Manual -- October 1999 CHAPTER 3 DISPLAY AND PROCESSING OF ANALYSIS RESULTS 1. INTRODUCTION ................................................................. 3-1 2. PROCESSING LATEST SAMPLES ...........................................3-2 2.1 Display of Analysis Result.................................................3-2 2.2 Manual Discrimination......................................................3-7 2.3 External Output............................................................ 3-11 3. PROCESSING STORED DATA .............................................. 3-14 3.1 Executing and Quitting Stored Data Processing Program ............ 3-14 3.2 Stored Data Screen........................................................ 3-15 3.3 Deletion..................................................................... 3-20 3.4 External Output............................................................ 3-21 3.5 Correcting a Sample Number............................................ 3-23
  • 74. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 3-1 1 . INTRODUCTION This instrument displays analysis result and information that assists in breaking down analysis result and outputs such data to external devices. This chapter describes the processing of analysis result, such as displaying latest or stored data on the screen or outputting them to external devices. The gist of the contents is as follows: Processing of Latest Samples When analysis is finished, analysis result is displayed in three kinds of screens. The display contents of Analysis Result screen, what they mean, and how to process them are explained here. Processing of Stored Data The analysis data stored in the instrument can be read at anytime. Description is made on the display contents of stored data, what they mean, deletion by marking, and output to external devices.
  • 75. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-2 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2 . PROCESSING LATEST SAMPLES 2.1 Display of Analysis Result The analysis result is displayed in the Analysis Result Display Area on the LCD screen. In the Analysis Result Display Area, the analysis result is displayed each time a new sample is analyzed. When the analysis result is displayed, the menu display area displays the menu of "1: M. Discri." and "2: Output," which can each be executed using the numeric keys. The Analysis screen consists of five pages that differ from each other in "Analysis Result Display Area." Use [ ] key or [ ] key to change over pages. P1. All Analysis Data Display Screen P2. CBC8 Parameter & Patient Limit Graph Display Screen P3. Calculation Parameter & Patient Limit Graph Display Screen P5. CBC8 Parameter & Particle Distribution Display Screen P4. Calculation Parameter & Particle Distribution Display Screen Figure 3-2-1: Page Selection in the Analysis Screen P1. All Analysis Data Display Screen 31/12 10:59No.123456789-12345 WB No.123456789-12346 PLT 180 P-LCR - 9.5 MCHC + 44.8 MPV 9.3 MCH 37.0 PDW - 7.9 MCV - 82.6 RDW-CV 20.5 HCT 32.8 RDW-SD - 25.6 HGB 14.7 NEUT% 49.2 3.5 RBC 3.97 MXD% 19.6 1.4 WBC 7.1 LYM% 31.2 2.2 Ready 1:M.Discri. 2:Output Latest Sample No. Mode Indication Menu Display Area Analysis Result Display Area Date/Time Analyzed System Status Display Area Figure 3-2-2: All Analysis Data Display Screen
  • 76. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 3-3 P2. CBC8 Parameter & Patient Limit Graph Display Screen 31/12 10:59No.123456789-12345 WB No.123456789-12346 PLT 180 ×103 /µL MCHC + 44.8 g/dL MCH 37.0 pg MCV - 82.6 fL HCT 32.8 % HGB 14.7 g/dL RBC 3.97 ×106 /µL WBC 7.1 ×103 /µL 1:M.Discri. 2:Output Ready Patient Limit Graph Latest Sample No. Mode Indication Date/Time Analyzed Figure 3-2-3: CBC8 Parameter & Patient Limit Graph Display Screen P3. Calculation Parameter & Patient Limit Graph Display Screen NOTE: • When analysis is made in the pre-diluted mode, particle distribution analysis parameters are displayed in "- - -. -." The particle distribution curve is not displayed. 31/12 10:59No.123456789-12345 WB No.123456789-12346 P-LCR - 9.5 % MPV 9.3 fL PDW - 7.9 fL RDW-CV 20.5 % RDW-SD - 25.6 fL NEUT% 49.2 % 3.5 MXD% 19.6 % 1.4 LYM% 31.2 % 2.2 1:M.Discri. 2:Output Ready Latest Sample No. Mode Indication Date/Time Analyzed Patient Limit Graph Figure 3-2-4: Calculation Parameter & Patient Limit Graph Display Screen
  • 77. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-4 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. P4. Calculation Parameter & Particle Distribution Display Screen 31/12 10:59No.123456789-12345 WB No.123456789-12346 WBC RBC PLT P-LCR - 9.5 % MPV 9.3 fL PDW - 7.9 fL RDW-CV 20.5 % RDW-SD - 25.6 fL NEUT% 49.2 % 3.5 MXD% 19.6 % 1.4 LYM% 31.2 % 2.2 1:M.Discri. 2:Output Ready WBC Particle Distribution Chart RBC Particle Distribution Chart PLT Particle Distribution Chart Latest Sample No. Mode Indication Date/Time Analyzed Figure 3-2-5: Calculation Parameter & Particle Distribution Display Screen P5. CBC8 Parameter & Particle Distribution Display Screen 31/12 10:59No.123456789-12345 WB No.123456789-12346 WBC RBC PLT PLT 180 ×103 /µL MCHC + 44.8 g/dL MCH 37.0 pg MCV - 82.6 fL HCT 32.8 % HGB 14.7 g/dL RBC 3.97 ×106 /µL WBC 7.1 ×103 /µL 1:M.Discri. 2:Output Ready Latest Sample No. Mode Indication Date/Time Analyzed WBC Particle Distribution Chart RBC Particle Distribution Chart PLT Particle Distribution Chart Figure 3-2-6: CBC8 Parameter & Particle Distribution Display Screen
  • 78. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 3-5 Display Contents of Analysis Data Display Screens 1 ) System Status Display Area This area displays the status of the instrument. For details, refer to Chapter 1, Section 8.1: Contents of Display. 2 ) Latest Sample No. The latest sample No. is displayed. 3 ) Mode Indication The latest sample's analysis mode is displayed. The whole blood mode is displayed as "WB" and the pre-diluted mode as "PD." 4 ) Date/Time Analyzed Date and time when analysis result was obtained are displayed. 5 ) Analysis Data The analysis data of the following 17 parameters or part of them are displayed depending on the screen: Analysis parameters (8): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT Calculation parameters (9): LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#, RDW-SD, RDW-CV, MPV The marks to the left of analysis data indicate the following: 1. ! : The data is out of the linearity limit. 2. * : The data is low in reliability because of a histogram error. 3. + : The data exceeds the upper Mark Limits. - : The data exceeds the lower Mark Limits. NOTE: • The marks are added with the priority order of 1, 2, and 3. • The Mark Limits with "+" and "-" can be set by the customer. For details, refer to Chapter 10, Section 4: Patient Limit. When an analysis error, etc. has caused errors in analysis data, the marks below are attached to the affected data: 1. + + +. +: When data has exceeded the display range. 2. * * *. *: When data could not be calculated due to instrument failure. 3. - - -. -: When data could not be calculated due to data error. NOTE: • When analysis is made in the pre-diluted mode, particle distribution analysis parameters are displayed in "- - -. -." Sysmex KX-21N Operator’s Manual -- Revised May 2003 N.A.
  • 79. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-6 Sysmex KX-21N Operator’s Manual -- October 1999 When an error is found in particle distribution, a histogram error flag among the following is displayed: 1. WL: Relative frequency of WBC-LD has exceeded the range. 2. WU: Relative frequency of WBC-UD has exceeded the range. 3. T1: T1 discriminator position cannot be determined. 4. T2: T2 discriminator position cannot be determined. 5. F1: Relative frequency of T1 has exceeded the range. 6. F2: Relative frequency of T1 or T2 has exceeded the range. 7. F3: Relative frequency of T2 has exceeded the range. 8. RL: Relative frequency of RBC-LD has exceeded the range. 9. RU: Relative frequency of RBC-UD has exceeded the range. 10. DW: Distribution width cannot be calculated. 11. MP: There are multiple peaks. 12. PL: Relative frequency of PLT-LD has exceeded the range. 13. PU: Relative frequency of PLT-UD has exceeded the range. 14. AG: The particle count equal to or less than WBC-LD has exceeded the range. NOTE: • When analysis is made in the pre-diluted mode, no flag is displayed to particle distribution analysis parameters. For details, refer to Chapter 9, Section 6: Particle Distribution Analysis. 6 ) Menu Display Area The Menu is displayed in accordance with the screen. For details, refer to Chapter 1, Section 8.1: Contents of Display. 7 ) Patient Limit Graph Synchronize with setting the Mark Limits value, and display whereabouts location of the analysis value for a standard range. Analysis value Abnormal range Abnormal range Center Mark Limit Upper Mark LimitLower Mark Limit Figure 3-2-7: Patient Limit Graph 8 ) WBC Particle Distribution Chart The WBC Particle distribution chart is displayed. 9 ) RBC Particle Distribution Chart The RBC Particle distribution chart is displayed. 10) PLT Particle Distribution Chart The PLT Particle distribution chart is displayed.
  • 80. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 3-7 2.2 Manual Discrimination This menu allows relocation of particle distribution discrimination position and re-calculation of data. CAUTION: • Manual Discrimination can be performed only on the latest sample displayed on the Analysis screen, but not on the data with sample number 0. NOTE: • "1: M. Discri." on the menu is valid only for the analysis result in the whole blood mode. Execution of Manual Discrimination (1) Press [1] key on the Analysis screen displaying analysis result and select "1: M. Discri." The pop-up menu to select the particle distribution for the manual discrimination will appear. 1 : W B C 2 : R B C 3 : P L T Figure 3-2-8: Pop-up Menu (2) Using [ ] key or [ ] key to select a desired particle distribution for the manual discrimination, and press [ENTER] key. The Manual Discrimination screen appears. M. Discri. Screen (WBC) 31/12 10:59No.123456789-12345 WB WBC NEUT# 3.5×103 /µL MXD# 1.4×103 /µL LYM# - 2.0×103 /µL NEUT% 49.2% MXD% 19.6% LYM% 31.2% WBC 7.1×103 /µL T2 144 fL T1 90 fL LD 30 fL *M.Discri.* [ ][ ] for item, [ ][ ] for cursor Figure 3-2-9: M. Discri. Screen (WBC)
  • 81. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-8 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. M. Discri. Screen (RBC) 31/12 10:59No.123456789-12345 WB RBC RDW - 25.6fL MCHC + 44.8g/dL MCH 37.0pg MCV - 82.6fL HCT 32.8% HGB 14.7g/dL RBC 3.97×106 /µL UD 250 fL LD 25 fL *M.Discri.* [ ][ ] for item, [ ][ ] for cursor Figure 3-2-10: M. Discri. Screen (RBC) M. Discri. Screen (PLT) 31/12 10:59No.123456789-12345 WB PLT P-LCR - 9.5% MPV 9.3fL PDW - 7.9fL PLT 180×103 /µL UD 30 fL LD 2 fL *M.Discri.* [ ][ ] for item, [ ][ ] for cursor Figure 3-2-11: M. Discri. Screen (PLT) (3) Using [ ] key or [ ] key, move the cursor to select the discriminator for manual discrimination. The discriminator selected on the Particle Distribution Chart is shown with solid line.
  • 82. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 3-9 (4) Using [ ] key or [ ] key, move the Discri. position on the Particle Distribution Chart. The Discri. position relocated is displayed. The range within which each Discri. position can move is shown below. Table 3-2-1: M. Discri. Screen (WBC) Discri. to Move Lower Limit Upper Limit LD 6 fL (0ch) T1 T1 LD T2 T2 T1 UD WBC particle distribution covers 50 channels of 0 to 49 (6 fL per channel), and the channel changes by one at a time. The relation between WBC particle distribution channel and fL display is as follows: Discri. position (fL) = (Channel No. + 1) × 6 Table 3-2-2: M. Discri. Screen (RBC) Discri. to Move Lower Limit Upper Limit LD 5 fL (0ch) UD UD LD 250 fL (49ch) RBC particle distribution covers 50 channels of 0 to 49 (5 fL per channel), and the channel changes by one at a time. The relation between RBC particle distribution channel and fL display is as follows: Discri. position (fL) = (Channel No. + 1) × 5 Table 3-2-3: M. Discri. Screen (PLT) Discri. to Move Lower Limit Upper Limit LD 1 fL (0ch) UD UD LD 40 fL (39ch) PLT particle distribution covers 40 channels of 0 to 39 (1 fL per channel), and the channel changes by one at a time. The relation between PLT particle distribution channel and fL display is as follows: Discri. position (fL) = (Channel No. + 1) × 1 (5) After Discri. movement, press [ENTER] key. The Discri. position is set and analysis data is re-calculated on the basis of new Discri. position. When [SELECT] key is pressed without pressing [ENTER] key, the Discri. position is not changed, and the status returns to the Discri. position selection status. (6) When you want to change another Discri., repeat the above (2) - (6) operation.
  • 83. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-10 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. (7) When Discri. change is finished, press [SELECT] key. The Setting Change Confirmation Message appears. OK to set? Cont. Set Cancel Figure 3-2-12: Setting Change Confirmation Message (8) Using [ ] key or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel," then press [ENTER] key. [Cont.]: Returns to the M. Discri. screen and allows M. Discri. operation. [Set]: Updates the contents and returns to the Analysis screen. [Cancel]: Cancels the changed contents and returns to the Analysis screen. (9) When you update the contents, analysis values changed in M. Discri. on the Analysis screen are reverse-displayed. 31/12 10:59No.123456789-12345 WB No.123456789-12346 PLT 180 P-LCR - 9.5 MCHC + 44.8 MPV 9.3 MCH 37.0 PDW - 7.9 MCV - 82.6 RDW-CV 20.5 HCT 32.8 RDW-SD - 25.6 HGB 14.7 NEUT% 49.2 3.5 RBC 39.7 MXD% 19.6 1.419.6 1.4 WBC 7.1 LYM% 31.2 2.231.2 2.2 Ready 1:M.Discri. 2:Output Figure 3-2-13: Analysis Screen
  • 84. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 3-11 2.3 External Output This menu can be used to print out the latest sample's analysis result from the built- in/external printer or output to the host computer. (The external printer is an option) Printing to Printer (1) Press [2] key on the Analysis screen and select "2: Output." The pop-up menu to select the output destination will appear. 1 : H o s t 2 : D P 3 : G P 4 : L P 5 : I P 6 : I P F e e d 7:StopOutput Figure 3-2-14: Pop-up Menu (2) Using [ ] key or [ ] key to move the cursor to the desired printer, and press [ENTER] key. [1: Host]: Output the data to the host computer. Refer to "Output to Host Computer" described later. [2: DP]: The data printer starts printing the analysis result of the latest sample. [3: GP]: The graphic printer starts graphic printing the analysis result of the latest sample. [4: LP]: This cannot be selected. [5: IP]: The built-in printer starts printing the analysis result of the latest sample. [6: IP Feed]: Carries out the paper feed of the built-in printer. [7: StopOutput]: This cannot be selected. Contents of Printing Contents of print with built-in printer No. 123456789-12345 Date 31/10/1999 Time 10:02 Mode WB [W][R][P] WBC WL+ 11.3 ×103 /µL RBC 3.80 ×106 /µL Mode Indication Parameter Discriminated Manually Sample No. Date Analyzed Time Analyzed Figure 3-2-15: Printing of Analysis Result (Built-in Printer) NOTE: • For printing format of built-in printer, refer to Chapter 2, Section 5.2: Printing of Analysis Result. To change the printing format, refer to Chapter 10, Section 7.3: IP Output Settings. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 85. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-12 Sysmex KX-21N Operator’s Manual -- October 1999 Contents of print with graphic printer Sample No.:123456789-12345 31/10/1999 16:40 Mode:WB Manual Ana:[W][R][P] [ERROR] WBC 7.3 [×103 /µL] RBC 4.52 [×106 /µL] HGB 14.8 [g/dL] HCT 36.2 [%] MCV 80.1 [fL] MCH 32.7 [Pg] MCHC 40.9 [g/dL] WBC Mode Indication Parameter Discriminated Manually Sample No. Date Analyzed Time Analyzed Figure 3-2-16: Analysis Result Graphic Print (Graphic Printer) Contents of print with data printer HEMATOLOGY Doctor Age Data Sample No. WBC ×103/µL RBC ×106/µL HGB g/dL HCT % MCV fL MCH pg MCHC g/dL W-SCR % W-MCR % W-LCR % W-SCC ×103/µL W-MCC ×103/µL W-LCC ×103/µL RDW-CV fL 10/12/1999 123456789012345 M F Carte No. Name Sample No. Date Analyzed 5.6+ 3.58 8.0 34.1 80.1 32.7 28.3 18.8 52.9 1.6 1.0 3.0 Figure 3-2-17: Analysis Result List Print (Data Printer) 1 ) Sample No. The latest sample No. is printed. 2 ) Mode Indication The mode in which sample was analyzed is printed. The whole blood mode is printed as "WB" and the pre-diluted mode as "PD."
  • 86. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 3-13 3 ) Date/Time Analyzed Date and time when analysis result was obtained are printed. 4) Parameter Discriminated Manually When M. Discri is used, the parameter discriminated manually are printed. Output to Host Computer (1) Press [2] key on the Analysis screen and select "2: Output." The pop-up menu to select the output destination will appear. (2) Using [ ] key or [ ] key to move the cursor to [1: Host], and press [ENTER] key. Output the analysis data of the latest sample to the host computer.
  • 87. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-14 Sysmex KX-21N Operator’s Manual -- October 1999 3 . PROCESSING STORED DATA This instrument is capable of storing data of up to 300 samples. The stored data is retained after the power is turned off and can be called up unless deleted. NOTE: • When the stored data exceeds 300, the oldest data are automatically deleted. 3.1 Executing and Quitting Stored Data Processing Program Executing the Program (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Using [ ] key or [ ] key, move the cursor to select "1: Stored Data." (3) Press [ENTER] key. The Stored Data screen [1/7] appears. Date 31/12 31/12 31/12 31/12 31/12 31/12 31/12 31/12 No.123456789-12345 31/12 10:59 [1/7] Time 09:59 10:05 10:10 10:25 10:28 10:30 10:40 10:50 No 123456789-12341*B WB DGH QC01 M QC DGH 123456789-12335 M WB DGH 123456789-12337 M WB DGH 123456789-12344 M PD DGH E 123456789-12345 A PD DG 123456789-12346 A WB GH 123456789-12341*M WB D *Stored Data* [ENTER] to mark. 3:Chg.Disp. Figure 3-3-1: Stored Data Screen Quitting the Program (1) Press [SELECT] key on the Stored Data screen. The Analysis screen returns. NOTE: • The sample No. and analysis mode on the Analysis screen return to the status before the execution of the stored data processing program.
  • 88. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 3-15 3.2 Stored Data Screen The Stored Data screen lists data of up to eight samples in the order of analysis. When the first Stored Data screen is displayed after turning on the power, the data of the last eight samples on the list are displayed. When a new sample is analyzed, its data is automatically added to the last line of the list. As to analysis data, up to four parameters are displayed on one page, and can be switched to the screen over seven pages with [ ] key or [ ] key. The analyzed date and information on the analysis data such as error mark etc. will appear on the first page ([1/7]). P1. Stored Data Screen [1/7] P2. Stored Data Screen [2/7] P7. Stored Data Screen [7/7] P3. Stored Data Screen [3/7] P6. Stored Data Screen [6/7] P4. Stored Data Screen [4/7] P5. Stored Data Screen [5/7] Figure 3-3-2: Page Selection in the Stored Data Screen Date 31/12 31/12 31/12 31/12 31/12 31/12 31/12 31/12 No.123456789-12345 31/12 10:59 [1/7] Time 09:59 10:05 10:10 10:25 10:28 10:30 10:40 10:50 No 123456789-12341*B WB DGH QC01 M QC DGH 123456789-12335 M WB DGH 123456789-12337 M WB DGH 123456789-12344 M PD DGH E 123456789-12345 A PD DG 123456789-12346 A WB GH 123456789-12341*M WB D *Stored Data* [ENTER] to mark. 3:Chg.Disp. Figure 3-3-3: Stored Data Screen [1/7] No. -12341* WB 7.7+ QC 7.5 -12346 WB 7.5+ -12345 WB 7.1 -12344 PD 7.2 -12337 PD 5.5- -12335 WB 7.0 -12341* WB 7.6+ No.123456789-12341 31/12 10:50 [2/7] WBC RBC 3.97 4.51 3.85 4.30+ 3.91 3.90 4.05 3.98 HGB 14.7 14.1 13.8 12.2 14.3 15.1 18.5 15.0 HCT 32.8 34.7 30.5 29.5- 32.0 40.2+ 31.4 35.1 *Stored Data* [ENTER] to mark. 3:Chg.Disp. Figure 3-3-4: Stored Data Screen [2/7]
  • 89. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-16 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. Key Operation for Stored Data Screen [ ] key: Moves up the underline cursor by one sample. When the underline cursor is at the top, the list scrolls down. [ ] key: Moves down the underline cursor by one sample. When the underline cursor is at the bottom, the list scrolls up. [ ], [ ] key: Changes over the page. [ENTER] key: Attaches or deletes marks. [SAMPLE No.] key: Allows you to correct the sample number at the underline cursor. [3] key: Displays the data at the underline cursor by the same form as Analysis screen. 1:M.Discri. 2:Output 3:Chg.Disp. WBC RBC HGB HCT MCV MCH MCHC PLT + 7.7 3.97 14.7 32.8 - 82.6 37.0 44.8 180 No.123456789-12341 WB 31/12 10:50 LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR 31.2 19.6 49.2 - 25.6 20.6 - 7.9 9.3 - 9.5 2.2 1.4 3.5 *Stored Data* Figure 3-3-5: Stored Data Screen The screen can be switched with [ ] key or [ ] key as well as Analysis screen, and press [3] key to return to Stored Data screen. For details on how to display Analysis screen, refer to Chapter 3, Section 2.1: Display of Analysis Result.
  • 90. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 3-17 Marking To mark the analysis data, specify an analysis data using the underline cursor and press [ENTER] key. The marked analysis data has a added to its left end and the underline cursor moves to the next analysis data. When an analysis data is marked, the Menu Display Area displays: “1: Delete”, “2: Output”, “3: Chg. Disp.” When the mark is already attached, press [ENTER] key to delete it. NOTE: • When you keep pressing [ENTER] key, the marking is made continuously. • When you return to the Analysis screen, all the marks on analysis data are deleted. No. -12341* WB 7.7+ QC 7.5 -12335 WB 7.5+ -12337 WB 7.1 -12344 PD 7.2 -12345 PD 5.5- -12346 WB 7.0 -12341* WB 7.6+ No.123456789-12345 31/12 10:30 [2/7] WBC RBC 3.97 4.51 3.85 4.30+ 3.91 3.90 4.05 3.98 HGB 14.7 14.1 13.8 12.2 14.3 15.1 18.5 15.0 HCT 32.8 34.7 30.5 29.5- 32.0 40.2+ 31.4 35.1 1:Delete 2:Output 3:Chg.Disp. *Stored Data* Figure 3-3-6: Marking the Data Display Contents of Stored Data Screen Date 31/12 31/12 31/12 31/12 31/12 31/12 31/12 31/12 No.123456789-12335 31/12 10:10 [1/7] Time 09:59 10:05 10:10 10:25 10:28 10:30 10:40 10:50 No 123456789-12341*B WB DGH QC01 M QC DGH 123456789-12335 M WB DGH 123456789-12337 M WB DGH 123456789-12344 M PD DGH E 123456789-12345 A PD DG 123456789-12346 A WB GH 123456789-12341*M WB D *Stored Data* [ENTER] to mark. 3:Chg.Disp. Not-output Mark Error Mark Data at Underline Cursor Sample No. Input Attributes Mode Indication Sample No. Date Analyzed Time Analyzed Figure 3-3-7: Stored Data Screen [1/7] Sysmex KX-21N Operator’s Manual -- Revised June 2001
  • 91. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-18 Sysmex KX-21N Operator’s Manual -- October 1999 No. -12341* WB 7.7+ QC 7.5 -12335 WB 7.5+ -12337 WB 7.1 -12344 PD 7.2 -12345 PD 5.5- -12346 WB 7.0 -12341* WB 7.6+ No.123456789-12335 31/12 10:10 [2/7] WBC RBC 3.97 4.51 3.85 4.30+ 3.91 3.90 4.05 3.98 HGB 14.7 14.1 13.8 12.2 14.3 15.1 18.5 15.0 HCT 32.8 34.7 30.5 29.5- 32.0 40.2+ 31.4 35.1 *Stored Data* [ENTER] to mark. 3:Chg.Disp. Data at Underline Cursor Mode Indication Analysis Data Sample No. Figure 3-3-8: Stored Data Screen [2/7] 1 ) Data/Time Analyzed The date and the time when analyzed the analysis data are displayed. 2 ) Sample No. The sample No. of stored data is displayed. The sample number is displayed by all of the 15 digits on [1/7] screen, but displayed by only 6 last digits on [2/7] to [7/7] screens. Identical sample Nos. processed on an identical analysis date are marked with * at the ends of the Nos. QC data are displayed in the format of "QC + File No." 3 ) Sample No. Input Attributes How to input the sample number is displayed by the marks 1. M: The sample number was input with the panel keyboard. 2. B: The sample number was input with the hand held barcode reader. 3. A: The sample number was input by automatic increment. 4 ) Mode Indication The analysis mode for stored data is displayed. "PD" is indicated for the pre-diluted mode while no indication is given for the whole blood mode. 1. WB: Whole blood mode 2. PD: Pre-diluted mode 3. QC: QC data 5 ) Not-output Mark It is displayed whether to output data to an external printer or the host computer by the marks. 1. D : The data has not been printed to the data printer. The mark disappears when printed. 2. G : The data has not been printed to the graphic printer. The mark disappears when printed. 3. H : The data is not output to the host computer. The mark disappears when output. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 92. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 3-19 6 ) Error Mark The E mark is displayed in data which an error occurs. 7 ) Analysis Data Analysis data of 17 parameters are displayed on over six pages of [2/7] to [7/7]. Stored Data Screen [2/7]: WBC, RBC, HGB, HCT Stored Data Screen [3/7]: MCV, MCH, MCHC, PLT Stored Data Screen [4/7]: WBC, LYM%, MXD%, NEUT% Stored Data Screen [5/7]: WBC, LYM#, MXD#, NEUT# Stored Data Screen [6/7]: RDW-SD, RDW-CV Stored Data Screen [7/7]: MPV • Manual Discrimination Data As to data changed through manual discrimination, analysis values are reverse- displayed. • Abnormal Marks The marks on the left of analysis data indicate the following: 1. ! : The data is out of the linearity limit. 2. * : The data is low in reliability because of a histogram error. 3. + : The data exceeds the upper Mark Limits. - : The data exceeds the lower Mark Limits. NOTE: • The marks are added with the priority order of 1, 2, and 3. • The Mark Limits with "+" and "-" can be set by the customer. For details, refer to Chapter 10, Section 4: Patient Limit. • Indication when Error When an analysis error, etc. has caused errors in analysis data, the marks below are attached to the affected data: 1. + + +. +: When data has exceeded the display range. 2. * * *. *: When data could not be calculated due to instrument failure. 3. - - -. -: When data could not be calculated due to data error. NOTE: • When analysis is made in the pre-diluted mode, particle distribution analysis parameters are displayed in "- - -. -." 8 ) Data at Underline Cursor The sample number (15 digits), the analyzed date, and the analyzed time of the analysis data on the underline cursor are displayed. Sysmex KX-21N Operator’s Manual -- Revised May 2003 N.A.
  • 93. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-20 Sysmex KX-21N Operator’s Manual -- October 1999 3.3 Deletion This menu allows deletion of marked analysis data from stored data. Execution of Deletion (1) Using the underline cursor, specify the analysis data you want to delete and press [ENTER] key. This puts the mark on the analysis data. (2) Press [1] key to select "1: Deletion." The Deletion Confirmation message appears. Delete? YES NO Figure 3-3-9: Deletion Confirmation Message (3) Using [ ] key or [ ] key, move the cursor to select "Yes" or "NO." [Yes]: Deletes the marked analysis data. [NO]: Cancels deletion. (4) Press [ENTER] key to execute the selected process. When you press [SELECT] key, the process is canceled. NOTE: • Before deleting data, make sure the KX-21N completes any output operation to the printer or host computer.
  • 94. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 3-21 3.4 External Output This menu allows the marked analysis data to be printed by the built-in/external printer, or output to the host computer. (The external printer is an option.) Printing to Printer (1) Using the underline cursor, specify the analysis data you want to print and press [ENTER] key. This puts the mark on the analysis data. (2) Press [2] key to select "2: Output." The pop-up menu to select the output destination will appear. 1 : H o s t 2 : D P 3 : G P 4 : L P 5 : I P 6 : I P F e e d 7:StopOutput Figure 3-3-10: Pop-up Menu (3) Using [ ] key or [ ] key to move the cursor to the desired printer, and press [ENTER] key. [1: Host]: Output the data to the host computer. Refer to "Output to Host Computer" described later. [2: DP]: This cannot be selected. [3: GP]: The graphic printer starts graphic printing the marked analysis data. [4: LP]: The graphic printer starts list printing the marked analysis data. [5: IP]: The built-in printer starts printing the marked analysis data. [6: IP Feed]: Carries out the paper feed of the built-in printer. [7: StopOutput]: When two or more analysis data are output, this can be selected, and the output will be interrupted when you select this. When the print to the printer is completed, disappearing the not-output mark for the printer which corresponding to the printed analysis data. NOTE: • For print format other than the LP (list print with the graphic printer), refer to Chapter 2, Section 5.2: Printing of Analysis Result or Chapter 3, Section 2.3 External Output. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 95. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3-22 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. Contents of Printing List print with the graphic printer Print Date 31/10/1999 Print Time 16:40 Sample No. Date Ana.Inf. 123456789-12344 31/10/1999 12:15 W R P Mode Err. P E WBC RDW-SD LMY% 7.3 8.3 27.2 RBC RDW-CV MXD% NEUT% LMY# MXD# NEUT# 4.52 14.8 36.2 80.1 32.7 15.0 8.3 13.4 59.4 2.0 2.0 4.3 40.9 9.1 206 14.8 HGB HCT MCV MCH MCHC PLT PDW MPV P-LCR page( 1) Figure 3-3-11: Stored Data List Print Output to Host Computer (1) Using the underline cursor, specify the analysis data you want to output to the host computer and press [ENTER] key. This puts the mark on the analysis data. (2) Press [2] key to select "2: Output." The pop-up menu to select the output destination will appear. 1 : H o s t 2 : D P 3 : G P 4 : L P 5 : I P 6 : I P F e e d 7:StopOutput Figure 3-3-12: Pop-up Menu (3) Using [ ] key or [ ] key to move the cursor to [1: Host], and press [ENTER] key. The analysis data is output to the host computer in order that the mark is put. The not-output of the output analysis data to the host computer disappears when the output to the host computer is completed. Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.
  • 96. DISPLAY AND PROCESSING OF ANALYSIS RESULTS Sysmex KX-21N Operator’s Manual -- October 1999 3-23 3.5 Correcting a Sample Number Use the [SAMPLE No.] key to correct a sample number of analysis data. (1) Use the underline cursor to select the desired analysis data, then press the [SAMPLE No.] key. The sample number on the bottom of the screen will be highlighted. No.123456789-12345 31/12 10:30 [2/7] -12345 PD 5.5- -12346 WB 7.0 -12341* WB 7.6+ 3.90 4.05 3.98 15.1 18.5 15.0 40.2+ 31.4 35.1 [ENTER] to mark. 3:Chg.Disp. Figure 3-3-13: Correcting a Sample Number (2) Use the numeric keypad to enter a new sample number, then press the [ENTER] key. (3) When the confirmation message appears, select the [Set] button. The sample number is changed, and the sample number input attribute becomes "M".
  • 97. Sysmex KX-21N Operator’s Manual -- October 1999 CHAPTER 4 MAINTENANCE AND SUPPLIES REPLACEMENT 1. INTRODUCTION ................................................................. 4-1 2. KX-21N MAINTENANCE CHECKLIST ..................................... 4-2 3 DAILY MAINTENANCE AND PROCEDURE ............................... 4-4 3.1 Clean TD Chamber and Diluted Sample Line (Shutdown)............. 4-4 3.2 Check Trap Chamber Level and Discard ................................. 4-6 4. WEEKLY MAINTENANCE AND PROCEDURE............................ 4-7 4.1 Clean SRV Tray............................................................. 4-7 5. MONTHLY MAINTENANCE AND PROCEDURE ......................... 4-9 5.1 Clean Waste Chamber (Rinse Sequence)................................. 4-9 5.2 Clean Transducer (Rinse Sequence) .....................................4-12 6. EVERY 3-MONTH MAINTENANCE AND PROCEDURE .............. 4-16 6.1 Clean Sample Rotor Valve (SRV)........................................4-16 6.2 Reset SRV Cycle Counter ................................................4-22 7. AS-NEEDED MAINTENANCE AND PROCEDURE...................... 4-24 7.1 Auto Rinse ..................................................................4-24 7.2 Clean Rinse Cup ...........................................................4-26 7.3 Clean WBC/RBC Transducer Aperture .................................4-28 7.4 Replace Waste Tank .......................................................4-32 8. SUPPLIES REPLACEMENT.................................................. 4-33 8.1 Replenish Reagent .........................................................4-33 8.2 Replace Fuse................................................................4-36 8.3 Replace Printer Paper......................................................4-37 8.4 Supplies List................................................................4-40 9. CONFIRMATION OF CYCLE NUMBER................................... 4-41 9.1 Operation Procedure ...................................................... 4-41
  • 98. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-1 1 . INTRODUCTION To ensure that the instrument can function in its best state, it is necessary to give scheduled maintenance. Perform maintenance according to the schedule below and record the result in the Maintenance Checklist. • Daily Maintenance Clean the TD chamber and diluted sample line. (Execute shutdown.) Check trap chamber level, and discard if necessary. • Weekly Maintenance Clean the sample rotor valve (SRV) tray. • Monthly Maintenance (or Every 2500 Samples) Clean the waste chamber (rinse sequence). Clean the transducer (rinse sequence). • Every 3-Month Maintenance (or Every 7500 Samples) Clean the sample rotor valve (SRV). • As-Needed Maintenance Auto Rinse Clean the rinse cup. Clean WBC/RBC transducer aperture. Replace the waste tank. This chapter describes supplies replacement together with these maintenance items. • Supplies Replacement Replenish reagent. Replace fuses. Replace printer paper.
  • 99. MAINTENANCE AND SUPPLIES REPLACEMENT 4-2 Sysmex KX-21N Operator’s Manual -- October 1999 2 . KX-21N MAINTENANCE CHECKLIST Signature 12345678910111213141516171819202122232425262728293031 DailyMaintenance Executeshutdown Checktrapchamber levelanddrain Signature 12345 Cleansamplingvalve(SRV)tray WeeklyMaintenance MaintenanceItem Day MaintenanceItemWeek Date,SignatureMaintenanceitem Cleanwastechamber(Rinsesequence) Cleantransducer(Rinsesequence) MonthlyMaintenance Date,Signature Maintenanceitem Replaceprinterpaper Date,Signature Replenishreagent Replacefuse SuppliesReplacement Cleansamplerotorvalve(SRV) MaintenanceitemDate,Signature Every3-MonthMaintenance Date,Signature MaintenanceitemDate,Signature CleanWBC/RBCtransduceraperture Replacewastetank Cleanrinsecup Autorinse As-NeededMaintenance Year:Month:
  • 100. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-3 Reagent Replenishment Record CELLPACK STROMATOLYSER-WH Lot No. DateExpiry Signature Expiry Date Expiry Expiry Date DateLot No.Lot No. Lot No. Signature Signature Signature
  • 101. MAINTENANCE AND SUPPLIES REPLACEMENT 4-4 Sysmex KX-21N Operator’s Manual -- October 1999 3 . DAILY MAINTENANCE AND PROCEDURE 3.1 Clean TD Chamber and Diluted Sample Line (Shutdown) By executing shutdown, the transducer chamber and diluted sample line are cleaned. Perform shutdown after completion of the day's work, and also at least once every 24 hours when this instrument is used continuously. (1) Press [SHUTDOWN] key in the Ready status. The Shutdown screen appears. 3:Cancel *Shutdown* Aspirate CELLCLEAN. It will take approx. 5 minutes. Ready Figure 4-3-1: Shutdown Screen NOTE: • When [3] key is pressed, shutdown is canceled and the Analysis screen returns. (2) In executing shutdown, set CELLCLEAN to the sample probe and press the start switch in that status. While "Aspirating" is being displayed on the screen, keep holding CELLCLEAN in the same state. Start Switch Figure 4-3-2: Pressing the Start Switch
  • 102. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-5 • Because CELLCLEAN is a strong alkaline detergent, take care not to have it adhere to the skin or clothes. If the skin or clothes should come in touch with it, flush it away using plenty of water. Otherwise, it can damage the skin or clothes. NOTE: • Once shutdown is executed, it cannot be canceled until completed. (3) When the buzzer sounds two times - beep, beep, - informing the completion of aspiration, remove CELLCLEAN from the sample probe. After that, shutdown is executed automatically. Rinsing *Shutdown* Please wait. Figure 4-3-3: Shutdown Execution Screen CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to bend the sample probe. (4) When shutdown is completed and the following message is displayed, turn off the power switch on the right side of the unit. 1:Re-boot Shut-down sequence was completed. Turn OFF the power. *Shutdown* Figure 4-3-4: Shutdown Completion Message Screen WARNING
  • 103. MAINTENANCE AND SUPPLIES REPLACEMENT 4-6 Sysmex KX-21N Operator’s Manual -- October 1999 NOTE: • Shutdown will take approximately 5 minutes. • When the [1] key is pressed, the unit will restart. 3.2 Check Trap Chamber Level and Discard After completion of analyses for the day, check trap chamber level and discard any liquid that has collected. (1) Turn off the power and wait approximately 30 seconds. (2) Turn the chamber on the left side of the unit counterclockwise and remove. Trap Chamber Loosen Float Figure 4-3-5: Checking the Trap Chamber (3) After discarding the liquid, mount the chamber. Make sure the float is inside. • When discarding the trap chamber liquid, always wear rubber gloves. After completion of operation, wash hands with disinfectant. If your hands are contaminated by the liquid, infection of bacteria or the like can occur. • If liquid collects everyday, the hydraulic system may have failed. Contact Sysmex service representative. • Pay attention to the direction of the float in the chamber. Place it with its pointed end facing upward. WARNING CAUTION
  • 104. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-7 4 . WEEKLY MAINTENANCE AND PROCEDURE 4.1 Clean SRV Tray Clean the sample rotor valve (SRV) tray once a week in the following procedure: • When cleaning the SRV tray, always wear rubber gloves. After completion of operation, wash hands with disinfectant. If your hands are contaminated by blood, etc., infection of bacteria or the like can occur. (1) Turn off the power of the main unit and wait approximately 30 seconds. (2) Open the front cover of the main unit. (3) Remove the SRV tray. Tray Probe Fixing Screw Figure 4-4-1: Removing the SRV Tray • When removing the tray, take care not to loosen the probe fixing screw. If analysis is made with the screw loosened, air can enter the system and affect the data. (4) Wash the SRV tray using tap water. Tray Figure 4-4-2: Washing the SRV Tray WARNING CAUTION
  • 105. MAINTENANCE AND SUPPLIES REPLACEMENT 4-8 Sysmex KX-21N Operator’s Manual -- October 1999 (5) Make sure no contaminants remain, then wipe off water. (6) Re-mount the SRV tray to the original state. • After mounting the tray, make sure the probe fixing screw is not loose. If analysis is made with the screw loosened, air can enter the system and affect the data. CAUTION: • Mount the SRV tray properly as to the face/bottom and the direction. (7) Close the front cover of the main unit. CAUTION
  • 106. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-9 5 . MONTHLY MAINTENANCE AND PROCEDURE 5.1 Clean Waste Chamber (Rinse Sequence) When the power is turned on, the message is displayed once a month or for every 2500 samples to instruct the scheduled maintenance. 1:Exec.Clean 3:Cancel *Scheduled Maint.* Clean the Waste Chamber. It will take approx. 15 minutes. Cycle No. after cleaning. 2515 Date last serviced 1/12/1999 Figure 4-5-1: Scheduled Maintenance Message Screen When this message appears, press [1] key to select "1: Exec. Clean," and clean the waste chamber by the following procedure: NOTE: • When you press [3] key and select "3: Cancel," the start-up process continues without cleaning the waste chamber. Until the waste chamber is cleaned, the above message is displayed at start-up. • Even when the above message is not displayed, you can execute the waste chamber cleaning by choosing "7: Maintenance" on the Select Menu screen, then "1: Clean W. Chamber" on the Maintenance Menu screen.
  • 107. MAINTENANCE AND SUPPLIES REPLACEMENT 4-10 Sysmex KX-21N Operator’s Manual -- October 1999 (1) Press [1] key to select "1: Exec. Clean" on the Scheduled Maintenance Message screen. The Clean W. Chamber screen will display the message instructing the following operation: *Clean W.Chamber* Cycle No. after cleaning. 2515 Date last serviced 1/12/1999 3:Cancel Ready Aspirate CELLCLEAN It will take approx. 15 minutes. Figure 4-5-2: Clean W. Chamber Screen NOTE: • When you press [3] key and select "3: Cancel," the start-up process continues without cleaning the waste chamber. Until the waste chamber is cleaned, the above message is displayed at start-up. (2) Set CELLCLEAN to the sample probe and press the start switch in that status. While "Aspirating" is being displayed on the screen, keep holding CELLCLEAN in the same status. Start Switch Figure 4-5-3: Pressing the Start Switch • Since CELLCLEAN is a strong alkaline detergent, take care not to have it adhere to the skin or clothes. If the skin or clothes should come in touch with it, flush it away using plenty of water. Otherwise, it can damage the skin or clothes. WARNING
  • 108. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-11 (3) When the buzzer sounds two times - beep, beep , - informing completion of aspiration, remove CELLCLEAN from the sample probe. After that, the waste chamber cleaning is executed automatically. *Clean W.Chamber* Please wait. Figure 4-5-4: Screen during Waste Chamber Cleaning CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to bend the sample probe. (4) When the waste chamber cleaning is completed, the auto rinse and background check are executed, then the system turns to the Ready status. (5) Check to see that no background error occurs. Should background error occur, execute the auto rinse. NOTE: • When this operation is completed, the waste chamber cycle counter is automatically reset. For the confirmation of waste chamber cycle number, refer to Chapter 4, Section 9: CONFIRMATION OF CYCLE NUMBER.
  • 109. MAINTENANCE AND SUPPLIES REPLACEMENT 4-12 Sysmex KX-21N Operator’s Manual -- October 1999 5.2 Clean Transducer (Rinse Sequence) When the power is turned on, the message is displayed once a month or for every 2500 samples to instruct the scheduled maintenance. 1:Exec. Clean Clean the Transducer. It will take approx. 7 minutes. *Scheduled Maint.* Cycle No. after cleaning. 2515 Date last serviced 1/12/1999 3:Cancel Figure 4-5-5: Scheduled Maintenance Message Screen When this message appears, press [1] key to select "1: Exec. Clean," and clean the transducer by the following procedure: In addition, the error message of clogging is displayed. Even when the clogging is not removed, clean the transducer using the same procedure. NOTE: • When you press [3] key and select "3: Cancel," the start-up process continues without cleaning the transducer. Until the transducer is cleaned, the above message is displayed at start-up. • Even when the above message is not displayed, you can execute the transducer cleaning by choosing "7: Maintenance" on the Select Menu screen, then "2: Clean Transducer" on the Maintenance Menu screen. • If this rinse sequence fails to remove clogging, clean with the brush. Regarding cleaning with the brush, refer to Chapter 4, Section 7.3: Clean WBC/RBC Transducer Aperture.
  • 110. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-13 (1) Press [1] key to select "1: Exec. Clean" on Scheduled Maintenance Message screen. Fluid in the transducer is drained and the Clean Transducer screen appears. *Clean Transducer* Pour CELLCLEAN in transducer chamber and press START switch. Cycle No. after cleaning. 2515 Date last serviced 1/12/1999 3:Cancel Ready Figure 4-5-6: Clean Transducer Screen NOTE: • When you press [3] key and select "3: Cancel," the start-up process continues without cleaning the transducer. Until the transducer is cleaned, the above message is displayed at start-up. (2) Open the front cover of the main unit. (3) Open the transducer cover. Figure 4-5-7: Opening the Transducer Cover
  • 111. MAINTENANCE AND SUPPLIES REPLACEMENT 4-14 Sysmex KX-21N Operator’s Manual -- October 1999 (4) Using the filler provided with the unit, pour approximately 1 mL each of CELLCLEAN into the WBC transducer and RBC transducer. Filler Figure 4-5-8: Pouring CELLCLEAN • Since CELLCLEAN is a strong alkaline detergent, take care not to have it adhere to the skin or clothes. If the skin or clothes should come in touch with it, flush it away using plenty of water. Otherwise, it can damage the skin or clothes. • Do not pour more than 1 mL of detergent (CELLCLEAN) into the chamber. It may overflow, possibly causing electric shocks or leakage. CAUTION: • Take care not to have detergent (CELLCLEAN) adhere to the chamber side wall. (5) Close the transducer cover. (6) Close the front cover of the main unit. WARNING CAUTION
  • 112. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-15 (7) Press the start switch. The transducer cleaning is executed. *Clean Transducer* Please wait. Figure 4-5-9: Screen during Transducer Cleaning (8) When the transducer cleaning is completed, the auto rinse and background check are executed, then the system turns to the Ready status. (9) Check to see that no background error occurs. Should background error occur, execute the auto rinse. NOTE: • When this operation is completed, the transducer cycle counter is automatically reset. For the confirmation of transducer cycle number, refer to Chapter 4, Section 9: CONFIRMATION OF CYCLE NUMBER.
  • 113. MAINTENANCE AND SUPPLIES REPLACEMENT 4-16 Sysmex KX-21N Operator’s Manual -- October 1999 6 . EVERY 3-MONTH MAINTENANCE AND PROCEDURE 6.1 Clean Sample Rotor Valve (SRV) When the power is turned on, the message is displayed once every three months or for every 7500 samples to instruct the scheduled maintenance. *Scheduled Maint.* Cycle No. after cleaning. 7515 Date last serviced 1/12/1999 1:Exec.Clean Clean the SRV. Reset the cycle counter for SRV, and you can turn OFF the power. [1] [3] Continue to start up. SRV cycle counter will not be reset. 3:Cancel Figure 4-6-1: Scheduled Maintenance Message Screen When this message appears, press [1] key to select "1: Exec. Clean," and reset the cycle counter. Then clean the sample rotor valve (SRV) by the following procedure: • When cleaning the sample rotor valve (SRV), always wear rubber gloves. After completion of operation, wash hands with disinfectant. If your hands are contaminated by blood, etc., infection of bacteria or the like can occur. • Because CELLCLEAN is a strong alkaline detergent, take care not to have it adhere to the skin or clothes. If the skin or clothes should come in touch with it, flush it away using plenty of water. Otherwise, it can damage the skin or clothes. NOTE: • When you press [3] key and select "3: Cancel," the start-up process continues without cleaning the sample rotor valve (SRV). Until the sample rotor valve (SRV) is cleaned, the above message is displayed at start-up. • When you want to clean before this message appears, or when you selected "3: Cancel" on the Scheduled Maint. screen and executed cleaning when the power was off, reset the cycle counter, making reference to Chapter 4, Section 6.2: Reset SRV Cycle Counter. WARNING
  • 114. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-17 (1) Press [1] key to select "1: Exec. Clean" on the Scheduled Maintenance Message screen. The SRV cycle counter is reset and the unit is ready to be turned off. *Scheduled Maint.* SRV cycle counter was reset. Turn OFF the power. Figure 4-6-2: Clean SRV Screen CAUTION: • Before turning the power off, always select "1: Exec. Clean," making the unit ready to be turned off. (2) Turn off the power of the main unit and wait approximately 30 seconds. (3) Open the front cover of the main unit. (4) Remove the sample rotor valve (SRV) tray. Tray Probe Fixing Screw Figure 4-6-3: Removing the Tray
  • 115. MAINTENANCE AND SUPPLIES REPLACEMENT 4-18 Sysmex KX-21N Operator’s Manual -- October 1999 • When removing the tray, take care not to loosen the probe fixing screw. If analysis is made with the screw loosened, air can enter the system and affect the data. (5) Gently push down the rinse cup using both hands. Make sure the rinse cup is removed completely from the sample probe. Sample Probe Rinse Cup Figure 4-6-4: Pushing Down the Rinse Cup CAUTION: • If the rinse cup is not completely removed from the sample probe, there is a possibility that the sample probe may bend when the sample rotor valve (SRV) is removed. (6) Remove the SRV fixing screw. SRV Fixing Screw Loosen Figure 4-6-5: Removing the SRV Fixing Screw CAUTION
  • 116. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-19 (7) Remove the entire sample rotor valve (SRV). Sample Rotor Valve Figure 4-6-6: Removing the Entire SRV CAUTION: • Take care not to pull out the valve excessively. This is to prevent applying excess force to the tube connected to the valve. • When removing the valve, take care not to bend the sample probe. (8) Remove the rotary valve. Rotary Valve Figure 4-6-7: Removing the Rotary Valve • When removing the valve, reagent could leak from the tube. If it does, wipe it clean using cloth. If left as it is, it can cause current leakage or electric shocks. NOTE: • The valve components are in close contact with one another. They can be easily removed when you gently twist and slide each one. CAUTION
  • 117. MAINTENANCE AND SUPPLIES REPLACEMENT 4-20 Sysmex KX-21N Operator’s Manual -- October 1999 (9) Clean the rotary valve using distilled water or 1:10 dilution of CELLCLEAN detergent. After cleaned with CELLCLEAN, always clean it with distilled water. (10) Clean the contact surfaces of the fixed and rotary valves using a gauze moistened with distilled water. By using CELLCLEAN together with distilled water, stuck objects, dirt, etc. can be removed easily. Figure 4-6-8: Cleaning the Contact Faces • Take care not to inflict flaws or scratches on valve surfaces, since flaws or scratches can cause blood leakage and incorrect analysis results. CAUTION: • Do not use any detergent other than CELLCLEAN. Although the sample rotor valve (SRV) is corrosion-resistant against CELLCLEAN, wipe it off completely to prevent troubles to the unit or other components. (11) Make sure the valve contact surfaces are completely free from dirt or dust. • If the device is used with dirt or dust attaching on valve contact surfaces, blood leakage can occur and correct analysis results may not be obtained. (12) Install one each valve at a time, and assemble the sample rotor valve (SRV) in the reverse order to disassembly. CAUTION CAUTION
  • 118. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-21 CAUTION: • Mount the rotary valve with the notch facing upward and the metal knob coming between the stoppers. Stopper Metal Knob Groove Guide Pin for Rotary Valve (View of Left Side) Figure 4-6-9: Rotary Valve • Confirm that the metal knob is between the stoppers. If it is not, malfunction will occur. (13) Mount the SRV tray to the original position and gently push up the rinse cup to the top using both hands. CAUTION: • Mount the SRV tray properly as to its face/bottom and the direction. • Make sure the rinse cup is pushed all the way up with the sample probe inserted in the hole. If the power is turned on with the rinse cup staying lowered, "Rinse Motor Error" will occur, making it impossible to continue the operation. (14) Close the front cover of the main unit. (15) Turn on the main unit and make sure that the background error has not occurred. (16) Perform quality control and make sure that there is no functional problem. NOTE: • When this operation is completed, the SRV cycle counter is automatically reset. For confirmation of SRV cycle number, refer to Chapter 4, Section 9: CONFIRMATION OF CYCLE NUMBER.
  • 119. MAINTENANCE AND SUPPLIES REPLACEMENT 4-22 Sysmex KX-21N Operator’s Manual -- October 1999 6.2 Reset SRV Cycle Counter If you have cleaned the SRV other than the time when instructed on the Scheduled Maintenance screen, always reset the SRV cycle counter manually. NOTE: • If you continue using the unit without resetting the SRV cycle counter, the message will instruct you to perform scheduled maintenance within three months (or before analyzing 7500 samples). • For SRV cleaning procedure, refer to Chapter 4, Section 6.1: Clean Sample Rotor Valve (SRV). (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Use [ ] key or [ ] key, move the cursor to select "7: Maintenance." (3) Press [ENTER] key. The Maintenance Menu screen appears. *Maintenance* 1:Clean W.Chamber 2:Clean Transducer 3:Reset SRV Counter 4:Drain TD Chamber 5:Status Display 6:Print Error History 7:Program Version Figure 4-6-10: Maintenance Menu Screen (4) Use [ ] key or [ ] key, move the cursor to select "3: Reset SRV Counter."
  • 120. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-23 (5) Press [ENTER] key. The Rest SRV Counter screen appears. *Reset SRV Counter* 3:Cancel1:Reset 1 SRV cycle counter will be reset.[ ] Cycle No. after cleaning. 6015 Date last serviced 1/12/1999 Figure 4-6-11: Reset SRV Counter Screen (6) Press [1] key to select "1: Reset." "Cycle No. after cleaning" is reset to "0," the date of the present day is entered in the "Date last serviced" column, then the Analysis screen returns. NOTE: • Press [3] key to select "3: Cancel." The cycle counter is not reset, and the Analysis screen returns. • For confirmation of SRV cycle counter, refer to Chapter 4, Section 9: CONFIRMATION OF CYCLE NUMBER.
  • 121. MAINTENANCE AND SUPPLIES REPLACEMENT 4-24 Sysmex KX-21N Operator’s Manual -- October 1999 7 . AS-NEEDED MAINTENANCE AND PROCEDURE When the transducer is clogged or the waste tank becomes full, perform the necessary maintenance. 7.1 Auto Rinse Execute the Auto Rinse at background check or when the unit has been left idle without shutdown performed. The Auto Rinse cleans all the lines in the unit and drains all waste. Background check is also implemented to allow checking whether the unit is in normal status or not. (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Using [ ] key or [ ] key, move the cursor to select "5: Auto Rinse." *SELECT* 1:Stored Data 2:Quality Control 3:Calibration 4:Replace Lyse 5:Auto Rinse 6:Settings 7:Maintenance 8:Periph. Settings 00:PU Sleep Figure 4-7-1: Select Menu Screen (3) Press [ENTER] key. Auto Rinse and background check are performed. NOTE: • On the Menu screen, each menu can be selected directly by entering a numeral from the numeric keys. *Auto Rinse* Please wait. Figure 4-7-2: Auto Rinse Execution Screen
  • 122. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-25 NOTE: • After Auto Rinse, background check is executed. When the background value of any parameter exceeds tolerance, background check is repeated a maximum of twice. In case background value still exceeds tolerance, the message "Background Error" appears while the alarm starts sounding. Press [HELP] key. This stops the alarm and the Action Message screen appears. Follow the Action Message screen and take appropriate action. (Refer to Chapter 7: TROUBLESHOOTING). • Background tolerance WBC 0.3 [×103 /µL] or less RBC 0.02 [×106 /µL] or less HGB 0.1 [g/dL] or less PLT 10 [×103 /µL] or less Table 4-7-1: Background tolerance
  • 123. MAINTENANCE AND SUPPLIES REPLACEMENT 4-26 Sysmex KX-21N Operator’s Manual -- October 1999 7.2 Clean Rinse Cup When the rinse cup has any blood on it or is clogged, clean it by the following procedure: • When cleaning the rinse cup, always wear rubber gloves. After completion of operation, wash hands with disinfectant. If your hands are contaminated by blood, etc., infection of bacteria or the like can occur. (1) Turn off the power of the main unit and wait approximately 30 seconds. (2) Open the front cover of the main unit. (3) Gently push down the rinse cup using both hands. Make sure the rinse cup is removed completely from the sample probe. Sample Probe Rinse Cup Figure 4-7-3: Pushing Down the Rinse Cup (4) Remove the rinse cup in the order of 1, 2, and 3 as shown below. Rinse Cup 3 2 1 Figure 4-7-4: Removing the Rinse Cup WARNING
  • 124. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-27 (5) Clean the rinse cup using tap water. Figure 4-7-5: Cleaning the Rinse Cup (6) Make sure no contaminant remains on the rinse cup and wipe off water. (7) Mount the rinse cup in the reverse order of removal. Route the thin tubes around the rear of the rinse cup. Rinse Cup 3 2 1 Figure 4-7-6: Mounting the Rinse Cup (8) Gently push up the rinse cup to the top using both hands. CAUTION: • Make sure the rinse cup is pushed all the way up with the sample probe inserted in the hole. If the power is turned on with the rinse cup staying lowered, "Rinse Motor Error" will occur, making it impossible to continue the operation.
  • 125. MAINTENANCE AND SUPPLIES REPLACEMENT 4-28 Sysmex KX-21N Operator’s Manual -- October 1999 7.3 Clean WBC/RBC Transducer Aperture If the transducer aperture clogging persists, clean the transducer aperture using the brush by the following procedure: • When cleaning the aperture, always wear rubber gloves. After completion of operation, wash hands with disinfectant. If your hands are contaminated by blood, etc., infection of bacteria or the like can occur. • Since CELLCLEAN is a strong alkaline detergent, take care not to have it adhere to the skin or clothes. If the skin or clothes should come in touch with it, flush it away using plenty of water. Otherwise, it can damage the skin or clothes. 1 . Preparation (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Use [ ] key or [ ] key, move the cursor to select "7: Maintenance." (3) Press [ENTER] key. The Maintenance Menu screen appears. *Maintenance* 1:Clean W.Chamber 2:Clean Transducer 3:Reset SRV Counter 4:Drain TD Chamber 5:Status Display 6:Print Error History 7:Program Version Figure 4-7-7: Maintenance Menu Screen (4) Use [ ] key or [ ] key, move the cursor to select "4: Drain TD Chamber." (5) Press [ENTER] key. Reagent in the transducer chamber is automatically drained. NOTE: • On the Menu screen, each menu can be selected directly by entering a numeral from the numeric keys. WARNING
  • 126. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-29 (6) When reagent in the transducer chamber is drained, the message instructing turning-off of the power is displayed, which indicates that it is ready for cleaning with the brush. *Drain TD Chamber.* 3:Cancel Fluid in T.D.Chamber was drained. Turn power OFF and dab the aperture with transducer brush. See the Operator's Manual. Figure 4-7-8: Drain TD Chamber Screen NOTE: • When you press [3] key, cleaning with brush is canceled and the Analysis screen returns. 2 . Clean Transducer Aperture (1) Turn off the power and wait approximately 30 seconds. (2) Open the front cover of the main unit. (3) Loosen the screw and open the transducer cover. Transducer Cover Loosen Screw Figure 4-7-9: Opening the Transducer Cover • When the power is on, never open the transducer cover. This is to prevent possible electric shocks. WARNING
  • 127. MAINTENANCE AND SUPPLIES REPLACEMENT 4-30 Sysmex KX-21N Operator’s Manual -- October 1999 (4) Confirm that reagent in the transducer chamber has been drained. RBC Transducer WBC Transducer Figure 4-7-10: Checking the WBC/RBC Transducer (5) Remove the transducer chamber plug. Plug Figure 4-7-11: Removing the Plug • A small volume of reagent occasionally remains. When reagent has leaked, wipe it off immediately using wet cloth or the like. If left as it is, it can cause current leakage or electric shocks. (6) Apply CELLCLEAN on the brush provided, and dab by lightly prodding the brush against the transducer aperture. Brush Aperture Figure 4-7-12: Cleaning the Aperture CAUTION
  • 128. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-31 NOTE: • After using the brush, wash it in water thoroughly to remove CELLCLEAN before storing it. (7) Mount the transducer chamber plug. • The transducer chamber plug should be mounted securely. Otherwise, current leakage or electric shocks can occur. (8) Close the transducer cover and main unit front cover. Then turn on the power. (9) Check to see that background error has not occurred. CAUTION
  • 129. MAINTENANCE AND SUPPLIES REPLACEMENT 4-32 Sysmex KX-21N Operator’s Manual -- October 1999 7.4 Replace Waste Tank When the waste tank has become full, replace it by the following procedure: • When replacing the waste tank, always wear rubber gloves. After replacing, wash hands with disinfectant. If your hands are contaminated by blood, etc., infection of bacteria or the like can occur. (1) Turn off the power of the main unit and wait approximately 30 seconds. (2) Make ready an empty waste container and remove the cap. (3) Pull the tube off the waste container. (4) Insert the tube in the new waste container and fix it using tape or the like. Tube Waste Tape Figure 4-7-13: Waste Container • When using a used reagent container as the waste container, make sure to clearly mark it that it is the waste container. WARNING CAUTION
  • 130. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-33 8 . SUPPLIES REPLACEMENT 8.1 Replenish Reagent When reagent becomes insufficient during analysis, the instrument comes to a stop, while the screen displays the error message. Press [HELP] key to change to the replenishment operation. Error Message (Analysis Screen) HELP Screen Reagent to Replenish Replenish Diluent *Help* Replenish Diluent Container. ERR CODE:XXXXX.X.X Reaspirating Diluent[1] 1:Asp. Reag. 3:Cancel CELLPACK Replenish Lyse 1:Asp.Reag. ERR CODE:12490.0.0 *Help* 3:Cancel Replenish Lyse Container. Reaspirating Lyse[1] STROMATOLYSER-WH NOTE: • Press [3] key on the HELP screen and select "3: Cancel" to return to the Analysis screen. Although Analysis screen displays the Not Ready status, the processing, etc. of stored data can be performed.
  • 131. MAINTENANCE AND SUPPLIES REPLACEMENT 4-34 Sysmex KX-21N Operator’s Manual -- October 1999 (1) Make ready a new reagent and check to see that expiration date is not passed. • CELLPACK, if used just after delivery via transit, sometimes develop a background error. • In handling a reagent that may have frozen, follow the precautions given on the Package Insert. Otherwise, correct analysis result may not be obtained. • Leave the reagent at room temperature (15 - 30°C) for at least 24 hours before using. • After unpacking, take care to prevent entry of dirt, dust, and bacteria. Table 4-8-1: Expiration After Opening the Seal (2) Remove the cap from the new reagent bottle. (3) Remove the cap from the empty reagent bottle and pull out the cubitainer spout set straight up. (4) Insert the cubitainer spout set straight down into the new reagent bottle and tighten the cap. Figure 4-8-1: Pulling Out the Cubitainer Spout Set • Take care not to grasp the tube dipping into the reagent and not allow dust, etc. to adhere to the tube. If dust, etc. adheres to the tube, wash it away with reagent in use before mounting. Otherwise, correct analysis results may not be obtained. • Replace only fresh and fully bottled lyse reagent. Old or collected lyse reagent will affect the analysis results. • Take care not to spill reagent. If it spills, wipe it off immediately using wet cloth, etc. to prevent the floor color fading. • When replacing lyse, you do not need to disconnect the float switch. If disconnected, connect it securely in prior to starting analysis. Starting analysis with disconnected float switch will give you an error message "No Lyse". CAUTION CAUTION CELLPACK 20 L 60 days STROMATOLYSER-WH 500 mL 90 days
  • 132. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-35 (5) When reagent replenishment is over, follow the instruction on the screen and press [1] key to select "1: Asp. Reag." Reagent is automatically aspirated, and then background check is performed. The check is made here to see that background error has not occurred. (6) Enter the contents of replenishment in Reagent Replenishment Record. NOTE: • If you replenish lyse before error message "No Reagent" appears, execute "4: Replace Lyse" on the Select Menu screen.
  • 133. MAINTENANCE AND SUPPLIES REPLACEMENT 4-36 Sysmex KX-21N Operator’s Manual -- October 1999 8.2 Replace Fuse The main unit employs overcurrent protective fuses. When a fuse is blown, replace it by the following procedure: (1) Disconnect the power cord on the right side of the main unit. • Before replacing the fuse, always turn off the power and disconnect the power cord to prevent possible electric shocks. (2) Pressing the notch upward with a regular screwdriver, remove the fuse cap holder. Fuse Fuse Cap Holder Notch Figure 4-8-2: Removing the Fuse Cap Holder (3) Replace the fuse and mount the fuse cap holder. Specification Part No. Description Fuse Type 117 VAC 266-5109-1 Fuse 250 V 3.15 A ST4-3.15A-N1 Time Lag 220/240 VAC 266-5292-6 Fuse 250 V 2 A No. 19195 Time Lag Table 4-8-2: Fuse Rating • For continued protection against risk of fire, use the fuse of the specified type and rating. WARNING CAUTION
  • 134. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-37 8.3 Replace Printer Paper When the "IP paper empty" message appears on the screen, press [HELP] key and replace printer paper of the built-in printer by the following procedure: *Help* IP paper empty ERR CODE:XXXXX.X.X Restarting to print Stop printing on IP [1] [3] To make IP on-line, press [SELECT], then [Periph. Settings] 1:Print 2:Paper Feed 3:Stop Output Figure 4-8-3: "IP paper empty" Message Screen NOTE: • On the HELP screen, press [3] and select "3: Stop Output" to stop printing on built-in printer. Analysis is executed as usual but printing is not. When you want to use built-in printer again, select "8: Periph. Settings" to set. (Refer to Chapter 10, Section 11: Peripheral Settings.) (1) Open the front cover of the main unit. (2) Turn the release lever up to free the paper. Release Lever Figure 4-8-4: Releasing the Lever
  • 135. MAINTENANCE AND SUPPLIES REPLACEMENT 4-38 Sysmex KX-21N Operator’s Manual -- October 1999 (3) Remove the bare paper core and mount a new printer paper. New Printer Paper Figure 4-8-5: Mounting a New Printer Paper NOTE: • When any printer paper remains, remove it together with the paper core. (4) Pass the printer paper as shown below, and turn the release lever down to secure. Figure 4-8-6: Securing the Release Lever
  • 136. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-39 (5) Cut off any printer paper extending from the upper part of the printer. Figure 4-8-7: Cutting Off Paper (6) Close the front cover of the main unit. (7) Press [1] key and output any print data that is remaining on the memory.
  • 137. MAINTENANCE AND SUPPLIES REPLACEMENT 4-40 Sysmex KX-21N Operator’s Manual -- October 1999 8.4 Supplies List 1 . Reagents List Product Code Product Name General Name 834-0161-8 CELLCLEAN (50 mL) Detergent 884-0871-1 CELLPACK (20 L) Diluent 974-0521-6 STROMATOLYSER-WH (500 mL × 3) WBC/HGB Lyse Table 4-8-3: Reagents List 2 . Consumable List Product Code Product Name Chapter & Section for Reference 933-3601-9 TRANSDUCER BLUSH NO.1 Chapter 4, Section 7.3: Clean WBC/RBC Transducer Aperture. 943-1781-1 CUBITAINER SPOUT KIT NO. 1 (20 L) Chapter 4, Section 8.1: Replace Reagent (Replacement of spout kit is suggested if background count will not drop when diluent has been replaced.) 973-3041-7 FLOAT SWITCH NO. 23 ASSY Chapter 4, Section 8.1: Replace Reagent (Replacement of float switch is suggested if WBC/HGB background count will not drop when lyse has been replaced.) 266-5292-6 FUSE 250 V, 2 A NO. 19195 Chapter 4, Section 8.2: Replace Fuse (220/240 VAC Spec.) 266-5109-1 FUSE 250 V, 3.15 A ST4-3.15A-N1 Chapter 4, Section 8.2: Replace Fuse (117 VAC Spec.) 921-0351-8 PAPER THERMAL F1-2 (5/BOX) Chapter 4, Section 8.3: Replace Printer Paper (Heat-Sensitive Paper) Table 4-8-4: Consumable List NOTE: • If you need to order supplies or replacement parts, please contact your local Sysmex representative. Sysmex KX-21N Operator’s Manual -- Revised August 2001
  • 138. MAINTENANCE AND SUPPLIES REPLACEMENT Sysmex KX-21N Operator’s Manual -- October 1999 4-41 9 . CONFIRMATION OF CYCLE NUMBER To let you know when to perform maintenance, this unit has the functions of cycle No. display and automatic reset. As to the waste chamber, transducer, and sample rotor valve (SRV), the next maintenance period is informed in accordance with the operation cycle No. or date, whichever comes first. Cleaning of waste chamber Every 2500 cycles or every month Cleaning of transducer Every 2500 cycles or every month Cleaning of sample rotor valve (SRV) Every 7500 cycles or every 3 months Table 4-9-1: Maintenance Timing Current cycle No. of each item can be checked by the following procedure: 9.1 Operation Procedure (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance." (3) Press [ENTER] key. The Maintenance Menu screen appears. *Maintenance* 1:Clean W.Chamber 2:Clean Transducer 3:Reset SRV Counter 4:Drain TD Chamber 5:Status Display 6:Print Error History 7:Program Version Figure 4-9-1: Maintenance Menu Screen (4) Using [ ] key or [ ] key, move the cursor to select "5: Status Display." (5) Press [ENTER] key. The Status Display screen 1 appears. NOTE: • On the Menu screen, each menu can be selected directly by entering a numeral from the numeric keys.
  • 139. MAINTENANCE AND SUPPLIES REPLACEMENT 4-42 Sysmex KX-21N Operator’s Manual -- October 1999 (6) Using [ ] key or [ ] key, turn over the page to display the Status Display screen 2. COUNTER 1234567 SRV 7567 DETECTOR 2567 WASTE CHAMBER 2567 WB Ready *Status* Cycle No. after cleaning waste chamber Cycle No. after cleaning transducer Cycle No. after cleaning SRV Change screen with [ ] or [ ]. Figure 4-9-2: Status Display Screen 2 NOTE: • Cycle number is the number of operations after the last maintenance. • When the power is turn-on and the counter exceeds the predetermined cycle number (or number of days), the message instructing the maintenance is displayed on the screen. At this time, the cycle number and the date of the last service are displayed. 1:Exec.Clean 3:Cancel *Scheduled Maint.* Clean the Waste Chamber. It will take approx. 15 minutes. Cycle No. after cleaning. 2515 Date last serviced 1/12/1999 Figure 4-9-3: Scheduled Maintenance Message Screen
  • 140. Sysmex KX-21N Operator’s Manual -- October 1999 CHAPTER 5 QUALITY CONTROL 1. INTRODUCTION ................................................................. 5-1 1.1 X Control.................................................................... 5-1 1.2 Levy-Jennings Control (L-J) .............................................. 5-1 1.3 QC Chart Screen ............................................................ 5-2 2. QC ANALYSIS PROCEDURE.................................................. 5-4 2.1 QC Analysis Procedure Flow Chart ...................................... 5-4 2.2 Execute QC Program ....................................................... 5-5 2.3 Select QC File ............................................................... 5-6 2.4 Erase All...................................................................... 5-7 2.5 Set TARGET/LIMIT Values............................................... 5-8 2.6 Execute X Control .........................................................5-10 2.7 Execute L-J Control........................................................5-19 2.8 Exit from QC Control Program...........................................5-26 3. DELETION ........................................................................5-27 4. EXTERNAL OUTPUT ..........................................................5-31 4.1 Printing to Printer ..........................................................5-31 4.2 Output to Host Computer .................................................5-35
  • 141. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-1 1 . INTRODUCTION Quality Control checks are performed to monitor an instrument’s performance over time. EIGHTCHECK-3WP is the quality control material recommended by Sysmex to monitor the performance of the KX-21N analyzer. This product is supplied with three control levels, at least two levels should be run every 8 hours of operation or in accordance to regulations applicable to your laboratory. Quality control material should be run after component replacement or after a service call. The KX-21N has two quality control methods. 1.1 X Control In X control, control blood is analyzed twice and the mean of the two is used to evaluate analyzer performance. 1.2 Levy-Jennings Control (L-J) The L-J control uses the data from a single control blood analysis to evaluated analyzer performance. NOTE: • Selection of the one of the two methods can be performed using QC method in the QC Settings program. Refer to "Chapter 10, Section 5: QC Settings."
  • 142. QUALITY CONTROL 5-2 Sysmex KX-21N Operator’s Manual -- October 1999 1.3 QC Chart Screen When the QC program is executed, the QC File List screen appears first. Six QC Files are displayed in the file list. Select the QC File used from among that, and display the QC Chart screen. The QC Chart can display QC data up to the latest 60 points. When a new data comes in, the oldest data is erased. The control parameters indicated in the QC Chart are displayed on multiple pages. [ ] key or [ ] key can be used to change over the screen. The Menu Display Area displays "1: QC Analyze," "2: Settings," and "3: Erase All." The menu can be executed using the numeric keys. P6. QC Chart Screen [6/8] P5. QC Chart Screen [5/8]P7. QC Chart Screen [7/8] P4. QC Chart Screen [4/8]P8. QC Chart Screen [8/8] P2. QC Chart Screen [2/8] P3. QC Chart Screen [3/8]P1. QC Chart Screen [1/8] Figure 5-1-1: Page Selection in QC Chart Screen (N=30) 31/10 UL WBC RBC HGB LL UL LL UL LL LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) FILE No.1 [1234567890][07/11/1999] Line cursor Exp.DateLot.No. 1:QC Analyze 2:Settings 3:Erase All Figure 5-1-2: QC Chart Screen
  • 143. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 5-3 The QC Chart screen displays QC data as shown below: 1 ) FILE No. FILE No. of QC Chart displayed on the screen 2 ) Lot. No. Lot number set in the QC File. 3 ) Exp. Data Expiration date set in the QC File. 4 ) N The number of control data plotted currently. In the case of X control, the average represents a data. 5 ) Control parameter Analysis parameters of control data are displayed on multiple pages: QC Chart screen [1/8]: WBC, RBC, HGB QC Chart screen [2/8]: HCT, MCV, MCH QC Chart screen [3/8]: MCHC, PLT QC Chart screen [4/8]: LYM%, MXD%, NEUT% QC Chart screen [5/8]: LYM#, MXD#, NEUT# QC Chart screen [6/8]: RDW-SD, RDW-CV QC Chart screen [7/8]: MPV QC Chart screen [8/8]: W-SMV, W-LMV 6 ) LIMIT (UL) The upper control limit. An analysis value exceeding this limit is a QC error. 7 ) LIMIT (LL) The lower control limit. An analysis value exceeding this limit is a QC error. 8 ) Target value QC Target value 9 ) DATA The QC data of the plot specified by the vertical line cursor. In the case of X control, it is the mean value of two consecutive analyses. 10) MEAN The mean of QC data plotted currently 11) Line Cursor The vertical line cursor can be moved to the right or left using [ ] key or [ ] key. The QC data of the plot shown by the line cursor, along with analysis date, are displayed.
  • 144. QUALITY CONTROL 5-4 Sysmex KX-21N Operator’s Manual -- October 1999 2 . QC ANALYSIS PROCEDURE 2.1 QC Analysis Procedure Flow Chart Execute QC program Select QC File Page 5-5 Page 5-6 New QC YES NO Erase All QC Data Set TARGET Values/ LIMIT Values Page 5-7 Page 5-8 Execute L-J ControlExecute X Control Page 5-19Page 5-10 Exit from QC Program Delete QC Data External Output Page 5-27 Page 5-26 Page 5-31 Figure 5-2-1: QC Analysis Procedure Flow Chart
  • 145. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-5 2.2 Execute QC Program (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Using [ ] key or [ ] key, move the cursor to select "2: Quality Control." (3) Press [ENTER] key. The QC File List screen appears. 1 :1 : [1234567890][07.11.1999] 2 : [1234567891][14.11.1999] 3 : [1234567892][21.11.1999] 4 : [1234567893][28.11.1999] 5 : [1234567894][01.12.1999] 6 : [1234567895][06.12.1999] Lot.No. Exp.Date *Quality Control* Figure 5-2-2: QC File List screen
  • 146. QUALITY CONTROL 5-6 Sysmex KX-21N Operator’s Manual -- October 1999 2.3 Select QC File This instrument stores six QC Files. To execute QC analysis, settings, file erasing, or HC output, display the QC Chart screen for a desired file as follows. How to Select QC File (1) Using [ ] key or [ ] key to move the cursor on the QC File List screen, and select a QC file to be selected. (2) Press [ENTER] key. The QC Chart screen for the selected QC file appears. NOTE: • The QC File can be selected directly by inputting file number of the QC File with numeric keys. • Press [SELECT] key to return from the QC Chart screen to the QC File List screen. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:QC Analyze 2:Settings 3:Erase All LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-2-3: QC Chart Screen
  • 147. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-7 2.4 Erase All To start quality control newly, the control data in the QC File has to be erased. When a control blood lot has changed, use the menu of "3: Erase All" to erase all control data in the QC File. How to Erase All QC Data (1) Display the QC Chart screen for the QC File you want to erase. For how to select the QC File, refer to Section 2.3: Select QC File in this chapter. (2) Press [3] key to select "3. Erase All." The Erase All Confirmation message appears. OK to erase all? Yes No Figure 5-2-4: Erase All Confirmation Message (3) Using [ ] key or [ ] key, move the cursor to select "Yes" or "No." [Yes]: Erases the plot display on the QC Chart screen and displays the second Erase All Confirmation message. [No]: Cancels the erasing of the plot display on the QC Chart screen and returns to the QC Chart screen. All are erasing. Execute Cancel Figure 5-2-5: Second Erase All Confirmation Message (4) Using [ ] key or [ ] key, move the cursor to select "Execute" or "Cancel." [Execute]: Completely erases QC data and returns to the QC Chart screen. [Cancel]: Cancels QC data erase and returns to the QC Chart screen. (5) Press [ENTER] key to execute the selected process.
  • 148. QUALITY CONTROL 5-8 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2.5 Set TARGET/LIMIT Values Before executing Quality Control anew, you have to set TARGET and LIMIT values for the QC File using "2: Settings" on the menu. Also, the lot number and the expiration date of the control blood can be registered at the same time as setting these. How to Set QC File (1) Display the QC Chart screen for the QC File you want to set. For how to select the QC File, refer to Section 2.3: Select QC File in this chapter. (2) Press [2] key to select "2: Settings." The QC File Setting screen appears. FILE No.1 TARGET LIMIT WBC 0.0 0.0 ×103 /µL RBC 0.00 0.00 ×106 /µL HGB 0.0 0.0 g/dL HCT 0.0 0.0 % MCV 0.0 0.0 fL MCH 0.0 0.0 pg MCHC 0.0 0.0 g/dL PLT 0 0 ×103 /µL Lot.No [ ] Exp.Date [ ] Press [SELECT] to exit. Figure 5-2-6: QC File Setting Screen (3) Move the cursor with [ ] key or [ ] key, and select Lot.No. (lot number), Exp.Date (expiration date) or the control parameter. Move the cursor with [ ] key or [ ] key, and select TARGET or LIMIT in the control parameter. NOTE: • There are 19 control parameters, but all the control parameters cannot be listed in one screen, so scroll the screen with [ ] key or [ ] key.
  • 149. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-9 (4) Enter the set values using the numeric keys. NOTE: • Each time you press [C] key in the middle of entering, one character disappears and the cursor moves to the left. For setting the lot number • The Lot number can be input up to 10 digits. • Also, the lot number can be input with the hand held barcode reader (option). For setting the expiration date • The expiration date can be input up to 10 digits. • Even if the expiration date is input, processing which judging the date in the program is not carried out. This is just a memo input for managing the QC File. For setting the control parameter • As a set value, up to five digits including decimal point can be entered. • The decimal point position is linked to the Unit System established in System Setup. For detail, refer to Chapter 10: INSTRUMENT SETTING, Section 2: System Setup. (5) Press [ENTER] key. The contents of settings are set and the cursor moves to the next item. NOTE: • The contents of settings are also set when [ ] key, [ ] key, [ ] key, or [ ] key is pressed after entering. (6) When settings are completed, press [SELECT] key. The Setting Confirmation message appears. OK to set? Cont. Set Cancel Figure 5-2-7: Setting Confirmation Message (7) Using [ ] key or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the QC File Setting screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the QC Chart screen. [Cancel]: Cancels the changed settings and returns to the QC Chart screen. (8) Press [ENTER] key to execute the selected process. NOTE: • QC chart will be drawn only if the TARGET and LIMIT values are both entered appropriately. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 150. QUALITY CONTROL 5-10 Sysmex KX-21N Operator’s Manual -- October 1999 2.6 Execute X Control The X control method for analyzing control blood is described here. (1) Display the QC Chart screen for the QC File in which to enter QC data. For how to select the QC File, refer to Chapter 2.3: Select QC File in this chapter. NOTE: • QC analysis is executed by control method (X control or L-J control) set in QC Settings. For setting procedures, refer to Chapter 10, Section 5: QC Settings. • While the X Control Analysis screen is displayed, the QC File cannot be changed. (2) Press [1] key to select "1: QC Analyze." The X Control Analysis screen appears. FILE No.1 QC X1 X2 X Judgement WBC RBC HGB HCT MCV MCH MCHC PLT Ready Figure 5-2-8: X Control Analysis Screen NOTE: • QC analysis is made in the whole blood mode. When the pre-diluted mode is selected as analysis mode, the Mode Change Sequence is activated to change over to the whole blood mode. (3) Confirm that "Ready" is displayed for QC analysis. • In analyzing control blood, always wear rubber gloves. After completion of work, wash the hands with disinfectant. If your hands are contaminated by blood, etc., infection of pathogenic bacteria can occur. WARNING
  • 151. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-11 (4) Mix control blood according to the package insert. Figure 5-2-9: Mixing the Control Blood (5) Remove the cap while taking care not to allow blood to scatter. Figure 5-2-10: Removing the Cap (6) Set the control blood container to the sample probe and press the start switch in that status. Start switch Figure 5-2-11: Pressing the Start Switch (7) When the buzzer sounds two times - beep, beep, - and "Analyzing" is displayed on the X Control Analysis screen, remove the control blood container. Then, automatic analysis is executed. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 152. QUALITY CONTROL 5-12 Sysmex KX-21N Operator’s Manual -- October 1999 The screens from the start to the end of analysis are as shown below. (Ready) FILE No.1 QC Ready (Aspirating) Aspirating FILE No.1 QC (Analyzing) Analyzing FILE No.1 QC (Rinsing) Rinsing FILE No.1 QC Figure 5-2-12: X Control Analysis Screen • While the screen is displaying "Aspirating," keep holding the control blood container in the aforementioned status. If the container is removed during its display, correct analysis may not be obtained. CAUTION: • Several seconds after the buzzer sounds "beep, beep" and "Analyzing" appears on the screen, the rinse cup lowers. Remove the control blood container by that time. • To remove the container, lower it straight down. Take care not to bend the sample probe. NOTE: • The sample probe is automatically rinsed, so there is no need to wipe it clean. CAUTION
  • 153. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 5-13 (8) Under the "X1" column on the Analysis Result screen, the 1st time analysis result is displayed. The analysis result comprises three screens which can be changed over by pressing [ ] key or [ ] key. P2. WBC Screen P3. RBC/PLT ScreenP1. CBC8 Parameter Screen Figure 5-2-13: Page Selection in QC Analysis Result Screen FILE No.1 QCQC X1 X2 X Judgement WBC 7.3 RBC 4.52 HGB 14.8 HCT 36.2 MCV 80.1 MCH 32.7 MCHC 40.9 PLT 206 Accept Data? 1:OK 2:NG 3:Print Figure 5-2-14: P1. CBC8 Parameter Screen Accept Data? 1:OK 2:NG 3:Print 31/12 10:02No.QC01-1 W-LMV 172.4fL W-SMV 56.3fL NEUT# 4.3×103 /µL WBC MXD# 1.0×103 /µL LYM# 2.0×103 /µL NEUT% 59.4% MXD% 13.4% LYM% 27.2% WBC 7.3×103 /µL FILE No.1 QC Figure 5-2-15: P2. WBC Screen Accept Data? 1:OK 2:NG 3:Print 31/10 10:02No.QC01-1 P-LCR 14.8% MPV 9.1fL PDW 8.3fL RBC PLT PLT 206×103 /µL RDW-CV 11.4% RDW-SD 27.4fL MCV 80.1fL RBC 4.52×106 /µL FILE No.1 QCQC Figure 5-2-16: P3. RBC/PLT Screen
  • 154. QUALITY CONTROL 5-14 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. If the data is acceptable, press [1] key to confirm. Press [2] key to reject. Press [3] key and select "3: Print" to print the contents of analysis result on the built-in printer. WBC [fl] RBC [fl] PLT [fl] No. QC01-1 Date 31/10/1999 Time 10:02 Mode QC WBC 7.3 ×103 /µL RBC 4.52 ×106 /µL HGB 14.8 g/dL HCT 36.2 % MCV 80.1 fL MCH 32.7 Pg MCHC 40.9 g/dL PLT 206 ×103 /µL LYM% 27.2 % MXD% 13.4 % NEUT% 59.4 % LYM# 2.0 ×103 /µL MXD# 1.0 ×103 /µL NEUT# 4.3 ×103 /µL W-SMV 56.3 fL W-LMV 172.4 fL RDW-SD 27.4 fL RDW-CV 11.4 % PDW 8.3 fL MPV 9.1 fL P-LCR 14.8 % Figure 5-2-17: Example of Analysis Result Printing NOTE: • Print of analysis result is valid until the data is set. If the data is set by pressing [1] key or [2] key, analysis result cannot be printed. • This print format cannot be changed since it is the special format for QC analysis.
  • 155. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-15 (9) Set the data using [1] key or [2] key. [1: OK]: Accepts analysis result as the 1st time QC data. And the system turns to be ready for the 2nd analysis. [2: NG]: Cancels the 1st time analysis result. And the system remains to be ready for another 1st time analysis. CAUTION: • When an error occurs during QC analysis, error message is displayed in the system status area. Press [HELP] key and perform the error recovery process. For the error recovery process, refer to Chapter 7: TROUBLESHOOTING. When you press [SELECT] key before setting the 1st QC data, the QC Cancel Confirmation message is displayed. OK to cancel? Yes No Figure 5-2-18: QC Cancel Confirmation Message Using [ ] key or [ ] key, move the cursor to select "Yes" or "No." [Yes]: Rejects analysis result, exits from QC program, and returns to the Analysis screen. [No]: Returns to the QC Analysis screen and allows continuous QC analysis. Press [ENTER] key to execute the selected process. (10) When the 1st analysis data is accepted, the (3) - (7) procedure is repeated for the 2nd analysis. (11) The 2nd analysis result is displayed under "X2" on the Analysis Result screen, the mean values of the 1st and the 2nd analyses under "X," and the comparison result with control limits under the "Judgment" column. The Analysis Result screen, as in the 1st analysis, can be changed over using [ ] key or [ ] key. The data confirmation message is displayed and you are asked to decide whether or not to accept the analysis result as QC data.
  • 156. QUALITY CONTROL 5-16 Sysmex KX-21N Operator’s Manual -- October 1999 Accept Data? 1:OK 2:NG 3:Print FILE No.1 QC X1 X2 X Judgement WBC 7.3 7.5 7.4 RBC 4.52 4.49 4.51 HGB 14.8 14.7 14.8 HCT 36.2 35.6 35.9 MCV 80.1 79.3 79.7 MCH 32.7 32.7 32.7 MCHC 40.9 41.3 41.1 PLT 206 209 208 Figure 5-2-19: Analysis Result Screen A parameters in which the mean of the 1st and the 2nd analyses fell outside the control limits is indicated with + or − under the "Judgment" column, while the alarm sounds and the QC error message appears. X1 X2 X Judgement WBC 7.3 7.5 7.4 RBC 4.52 4.49 4.51 HGB 14.8 14.7 14.8 HCT 42.5 43.0 42.8 + MCV 94.0 95.8 94.9 + MCH 32.7 32.7 32.7 MCHC 34.8 34.1 34.5 - PLT 106 109 108 - FILE No.1 QC QC Error Accept Data? 1:OK 2:NG 3:Print Figure 5-2-20: QC Error Message Screen (12) Set the data using [1] key or [2] key. [1: OK]: QC data is accepted and the plot is entered to the QC Chart. This QC data (mean) is kept in the stored data also. [2: NG]: Cancels the 2nd analysis result. And the system remains to be ready for the 2nd analysis again. CAUTION: • When an error occurs during QC analysis, the error message appears in the system status area. Press [HELP] key and perform the error recovery process. For the error recovery process, refer to Chapter 7: TROUBLESHOOTING.
  • 157. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 5-17 (13) The set data (mean) is printed on the built-in printer. No. QC01-1 Date 31/10/1999 Time 10:02 Mode QC WBC 7.4 ×103 /µL RBC 4.51 ×106 /µL HGB 14.8 g/dL HCT 35.9 % MCV 79.7 fL MCH 32.7 Pg MCHC 41.1 g/dL PLT 208 ×103 /µL LYM% 27.2 % MXD% 13.4 % NEUT% 59.4 % LYM# 2.0 ×103 /µL MXD# 1.0 ×103 /µL NEUT# 4.3 ×103 /µL W-SMV 56.3 fL W-LMV 172.4 fL RDW-SD 27.4 fL RDW-CV 11.4 % PDW 8.3 fL MPV 9.1 fL P-LCR 14.8 % Figure 5-2-21: Example of Printing NOTE: • Printing in QC settings is valid only when the "Built-in Printer" is selected. For detail, refer to Chapter 10, Section 5: QC Settings. • This print format cannot be changed since it is the special format for QC analysis. (14) The set data (mean) is output to the host computer. NOTE: • Transmission to the host is valid only when the "Host Output" is selected. For detail, refer to Chapter 10, Section 5: QC Settings. • As to the host output format, refer to Appendix B: Technical Information.
  • 158. QUALITY CONTROL 5-18 Sysmex KX-21N Operator’s Manual -- October 1999 When you press [SELECT] key before setting the 2nd QC data, the QC Cancel Confirmation message appears. OK to cancel? Yes No Figure 5-2-22: QC Cancel Confirmation Message Using [ ] key or [ ] key, move the cursor to select "Yes" or "No." [Yes]: Rejects analysis result, exists from the QC program, and returns to the Analysis screen. [No]: Returns to the QC Analysis screen and allows continuous QC analysis. Press [ENTER] key to execute the selected process.
  • 159. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-19 2.7 Execute L-J Control How to analyze control blood by L-J control is described here. (1) Display the QC Chart screen for the QC File in which to enter QC data. For how to select the QC File, refer to Chapter 2.3: Select QC File in this chapter. NOTE: • QC analysis is executed by control method (X control or L-J control) set in QC Settings. For setting procedures, refer to Chapter 10, Section 5: QC Settings. • While the L-J Control Analysis screen is displayed, the QC File cannot be changed. (2) Press [1] key to select "1: QC Analyze." The L-J Control Analysis screen appears. FILE No.1 QC Data Judgement WBC RBC HGB HCT MCV MCH MCHC PLT Ready Figure 5-2-23: L-J Control Analysis Screen NOTE: • QC analysis is made in the whole blood mode. When the pre-diluted mode is selected as analysis mode, the Mode Change Sequence is activated to change over to the whole blood mode. (3) Confirm that "Ready" is displayed for QC analysis. • In analyzing control blood, always wear rubber gloves. After completion of work, wash the hands with disinfectant. If your hands are contaminated by blood, etc., infection of pathogenic bacteria can occur. WARNING
  • 160. QUALITY CONTROL 5-20 Sysmex KX-21N Operator’s Manual -- October 1999 (4) Mix control blood according to the package insert. Figure 5-2-24: Mixing the Control Blood (5) Remove the cap while taking care not to allow blood to scatter. Figure 5-2-25: Removing the Cap (6) Set the control blood container to the sample probe and press the start switch in that status. Start switch Figure 5-2-26: Pressing the Start Switch (7) When the buzzer sounds two times - beep, beep, - and "Analyzing" is displayed on the L-JControl Analysis screen, remove the control blood container. Then, automatic analysis is executed. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 161. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-21 The screens from the start to the end of analysis are as shown below. (Ready) FILE No.1 QC Ready (Aspirating) Aspirating FILE No.1 QC (Analyzing) Analyzing FILE No.1 QC (Rinsing) Rinsing FILE No.1 QC Figure 5-2-27: L-J Control Analysis Screen • While the screen is displaying "Aspirating," keep holding the control blood container in the aforementioned status. If the container is removed during its display, correct analysis may not be obtained. CAUTION: • Several seconds after the buzzer sounds "beep, beep" and "Analyzing" appears on the screen, the rinse cup lowers. Remove the control blood container by that time. • To remove the container, lower it straight down. Take care not to bend the sample probe. NOTE: • The sample probe is automatically rinsed, so there is no need to wipe it clean. CAUTION
  • 162. QUALITY CONTROL 5-22 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. (8) Analysis result is given under the "Data" column on the Analysis Result screen and comparison result with QC limits under the "Judgment" column. The analysis result comprises three screens which can be changed over by pressing [ ] key or [ ] key. P2. WBC Screen P3. RBC/PLT ScreenP1. CBC8 Parameter Screen Figure 5-2-28: Page Selection in QC Analysis Result Screen Data Judgement WBC 7.3 RBC 4.52 HGB 14.8 HCT 36.2 MCV 80.1 MCH 32.7 MCHC 40.9 PLT 206 FILE No.1 QC Accept Data? 1:OK 2:NG 3:Print Figure 5-2-29: P1. CBC8 Parameter Screen Accept Data? 1:OK 2:NG 3:Print 31/10 10:02No.QC01-1 W-LMV 172.4fL W-SMV 56.3fL NEUT# 4.3×103 /µL WBC MXD# 1.0×103 /µL LYM# 2.0×103 /µL NEUT% 59.4% MXD% 13.4% LYM% 27.2% WBC 7.3×103 /µL FILE No.1 QC Figure 5-2-30: P2. WBC Screen Accept Data? 1:OK 2:NG 3:Print 31/10 10:02No.QC01-1 P-LCR 14.8% MPV 9.1fL PDW 8.3fL RBC PLT PLT 206×103 /µL RDW-CV 11.4% RDW-SD 27.4fL MCV 80.1fL RBC 4.52×106 /µL FILE No.1 QCQC Figure 5-2-31: P3. RBC/PLT Screen
  • 163. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-23 As to those parameters whose analysis fell beyond control limits, + or − is displayed under the "Judgment" column, while the alarm sounds with the QC error message displayed. Accept Data? 1:OK 2:NG 3:Print Data Judgement WBC 7.5 RBC 4.49 HGB 14.7 HCT 43.0 + MCV 95.6 + MCH 32.7 MCHC 34.1 - PLT 109 - FILE No.1 QC QC Error Figure 5-2-32: QC Error Message Screen If the data is acceptable, press [1] key to confirm. Press [2] key to reject. Press [3] key and select "3: Print" to print the contents of analysis result on the built-in printer.
  • 164. QUALITY CONTROL 5-24 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. WBC [fl] RBC [fl] PLT [fl] No. QC01-1 Date 31/10/1999 Time 10:02 Mode QC WBC 7.3 ×103 /µL RBC 4.52 ×106 /µL HGB 14.8 g/dL HCT 36.2 % MCV 80.1 fL MCH 32.7 Pg MCHC 40.9 g/dL PLT 206 ×103 /µL LYM% 27.2 % MXD% 13.4 % NEUT% 59.4 % LYM# 2.0 ×103 /µL MXD# 1.0 ×103 /µL NEUT# 4.3 ×103 /µL W-SMV 56.3 fL W-LMV 172.4 fL RDW-SD 27.4 fL RDW-CV 11.4 % PDW 8.3 fL MPV 9.1 fL P-LCR 14.8 % Figure 5-2-33: Example of Analysis Result Printing CAUTION: • Print of analysis result is valid until the data is set. If the data is set by pressing [1] key or [2] key, analysis result cannot be printed. • This print format cannot be changed since it is the special format for QC analysis. (9) Set the data using [1] key or [2] key. [1: OK]: Sets QC data, and the plot is entered to the QC Chart. This QC data is kept in the stored data. [2: NG]: Cancels the analysis result, and the system remains to be ready for another analysis .
  • 165. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 5-25 CAUTION: • When an error occurs during QC analysis, error message is displayed in the system status area. Press [HELP] key and perform the error recovery process. For the error recovery process, refer to Chapter 7: TROUBLESHOOTING. (10) The set data is printed on the built-in printer. No. QC01-1 Date 31/10/1999 Time 10:02 Mode QC WBC 7.4 ×103 /µL RBC 4.51 ×106 /µL HGB 14.8 g/dL HCT 35.9 % MCV 79.7 fL MCH 32.7 Pg MCHC 41.1 g/dL PLT 208 ×103 /µL LYM% 27.2 % MXD% 13.4 % NEUT% 59.4 % LYM# 2.0 ×103 /µL MXD# 1.0 ×103 /µL NEUT# 4.3 ×103 /µL W-SMV 56.3 fL W-LMV 172.4 fL RDW-SD 27.4 fL RDW-CV 11.4 % PDW 8.3 fL MPV 9.1 fL P-LCR 14.8 % Figure 5-2-34: Example of Printing NOTE: • Printing in QC settings is valid only when the "Built-in Printer" is selected. For detail, refer to Chapter 10, Section 5: QC Settings. • This print format cannot be changed since it is the special format for QC analysis. (11) The set data is output to the host computer. NOTE: • Transmission to the host is valid only when the "Host Output" is selected. For detail, refer to Chapter 10, Section 5: QC Settings. • As to the host output format, refer to Appendix B: Technical Information.
  • 166. QUALITY CONTROL 5-26 Sysmex KX-21N Operator’s Manual -- October 1999 When you press [SELECT] key before setting the QC data, the QC Cancel Confirmation message appears. OK to cancel? Yes No Figure 5-2-35: QC Cancel Confirmation Message Using [ ] key or [ ] key, move the cursor to select "Yes" or "No." [Yes]: Rejects analysis result, exist from the QC program, and returns to the Analysis screen. [No]: Returns to the QC Analysis screen and allows continuous QC analysis. Press [ENTER] key to execute the selected process. 2.8 Exit from QC Control Program (1) Press [SELECT] key on the QC Chart screen. The QC File List screen returns. (2) Press [SELECT] key. The Analysis screen returns. NOTE: • The sample No. and analysis mode on the Analysis screen return to those displayed before execution of the QC program.
  • 167. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-27 3 . DELETION This menu can delete one data or the range specified data of QC data in the line cursor position. How to delete QC Data (Deletion only of one data) (1) Display the QC Chart screen of QC file that contains the data you want to delete. For how to select QC file, refer to Chapter 2.3: Select QC File in this chapter. (2) Using [ ] key or [ ] key, move the line cursor to the position of the data to be deleted. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:QC Analyze 2:Settings 3:Erase All LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-3-1: QC Chart Screen (3) Press [ENTER] key. The line cursor changes from dotted line to solid line, and the menu in the Menu Display Area changes over to "1: Delete," "2: Output," "3: RangeSpec.". NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the menu in the Menu Display Area change to the original status. • The line cursor that has changed to solid line cannot be moved. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:Delete 2:Output 3:RangeSpec. LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-3-2: QC Chart Screen (At Data Selection)
  • 168. QUALITY CONTROL 5-28 Sysmex KX-21N Operator’s Manual -- October 1999 (4) Press [1] key to select "1: Delete." The Deletion confirmation message appears. OK to Delete? Yes No Figure 5-3-3: Deletion Confirmation Message (5) Using [ ] key or [ ] key, move the cursor to select "Yes" or "No." [Yes]: Deletes QC data of the plot shown by the line cursor and returns the line cursor to the dotted line. [No]: Cancels deletion of QC data and returns the line cursor to the dotted line. (6) Press [ENTER] key to execute the selected process. How to delete QC Data (Deletion of range specified data) (1) Display the QC Chart screen of QC file that contains the data you want to delete. For how to select QC file, refer to Chapter 2.3: Select QC File in this chapter. (2) Using [ ] key or [ ] key, move the line cursor to the end of the data within the deleted range. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:QC Analyze 2:Settings 3:Erase All LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-3-4: QC Chart Screen
  • 169. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-29 (3) Press [ENTER] key. The line cursor changes from dotted line to solid line, and the menu in the Menu Display Area changes over to "1: Delete," "2: Output," "3: RangeSpec.". NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the menu in the Menu Display Area change to the original status. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:Delete 2:Output 3:RangeSpec. LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-3-5: QC Chart Screen (At Data Selection) (4) Press [3] key to select "3: RangeSpec.". Move the line cursor of the dotted line for range specification of the other end. (5) Using [ ] key or [ ] key, move the line cursor to the other end of the data within the deleted range. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:Delete 2:Output 3:RangeSpec. LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-3-6: QC Chart Screen (At Data Range Specification) (6) Press [ENTER] key. The line cursor changes from dotted line to solid line.
  • 170. QUALITY CONTROL 5-30 Sysmex KX-21N Operator’s Manual -- October 1999 (7) Press [1] key to select "1: Delete." The Deletion confirmation message appears. OK to Delete? Yes No Figure 5-3-7: Deletion Confirmation Message (8) Using [ ] key or [ ] key, move the cursor to select "Yes" or "No." [Yes]: Deletes QC data of the plot shown by two line cursors and returns the line cursor to the dotted line. [No]: Cancels deletion of QC data and returns the line cursor to the dotted line. (9) Press [ENTER] key to execute the selected process.
  • 171. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-31 4 . EXTERNAL OUTPUT Using this menu, QC data in the line cursor position can be printed out from the built- in/external printer or output to the host computer. (The external printer is an option). 4.1 Printing to Printer How to print QC Data (1) Display the QC Chart screen of QC file that contains the data you want to print. For how to select QC file, refer to Chapter 2.3: Select QC File in this chapter. (2) Using [ ] key or [ ] key, move the line cursor to the position of the data to be printed. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:QC Analyze 2:Settings 3:Erase All LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-4-1: QC Chart Screen
  • 172. QUALITY CONTROL 5-32 Sysmex KX-21N Operator’s Manual -- October 1999 (3) Press [ENTER] key. The line cursor changes from dotted line to solid line, and the menu in the Menu Display Area changes over to "1: Delete," "2: Output," "3: RangeSpec.". NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the menu in the Menu Display Area change to the original status. • The line cursor that has changed to solid line cannot be moved. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:Delete 2:Output 3:RangeSpec. LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-4-2: QC Chart Screen (At Data Selection) (4) Press [3] key to select "3: RangeSpec.". Move the line cursor of the dotted line for range specification of the other end. (5) Using [ ] key or [ ] key, move the line cursor to the other end of the data within the printing range. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:Delete 2:Output 3:RangeSpec. LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-4-3: QC Chart Screen (At Data Range Specification) (6) Press [ENTER] key. The line cursor changes from dotted line to solid line.
  • 173. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-33 (7) Press [2] key to select "2: Output." The pop-up menu to select the output destination will appear. 1 : H o s t 2 : D P 3 : G P 4 : L P 5 : I P 6 : I P F e e d 7:StopOutput Figure 5-4-4: Pop-up Menu (8) Using [ ] key or [ ] key to move the cursor to the desired printer, and press [ENTER] key. [1: Host]: Output the data to the host computer. Refer to 4.2: Output to Host Computer in this chapter. [2: DP]: This cannot be selected. [3: GP]: The graphic printer starts graphic printing the QC data of the plot which the line cursor shows. [4: LP]: The graphic printer starts list printing the QC data of the plot which the line cursor shows. [5: IP]: The built-in printer starts printing the QC data of the plot which the line cursor shows. [6: IP Feed]: Carries out the paper feed of the built-in printer. [7: StopOutput]: When two or more analysis data are output, this can be selected, and the output will be interrupted when you select this. When the print to the printer is completed, the line cursor returns to the dotted line, and the menus of the menu display area returns to "1: QC Analyze", "2: Settings" and "3: Erase All." Contents of Printing Contents of print with built-in printer No. QC01-01 Date 31/10/1999 Time 10:02 Mode QC WBC 7.3 ×103 /µL RBC 4.52 ×106 /µL HGB 14.8 g/dL HCT 36.2 % MCV 80.1 fL MCH 32.7 Pg MCHC 40.9 g/dL PLT 206 ×103 /µL Time Analyzed Analysis Mode Date Analyzed File No. Figure 5-4-5: Contents of print with built-in printer Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 174. QUALITY CONTROL 5-34 Sysmex KX-21N Operator’s Manual -- October 1999 Contents of graphic print with graphic printer .... Print Date 31/10/1999 Print Time 10:26 File No.1 7/10/1999 - 30/10/1999(N=60) WBC Target/Limit 8.1 7.6 7.8 7.3 0 7.1 Mean SD CV% Lot.No.[1234567890] Exp.Date[07.11.1999] page( 1) PBC 4.70 4.50 4.55 4.52 0 4.30 HGB 15.5 15.0 15.0 14.8 0 14.0 UL LL UL LL UL LL Figure 5-4-6: Contents of graphic print with graphic printer Contents of list print with graphic printer This is printed by the same format as the stored data list print. Refer to Chapter 3, Section 3.4: External Output. 1 ) File No. File No. of QC file is printed. 2 ) Analysis Mode In the case of QC data, "QC" is printed. 3 ) Date/Time Analyzed Printed is the date and time when analysis result was obtained. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 175. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-35 4.2 Output to Host Computer Using this menu, QC data in the line cursor position can be output to the host computer (option). How to output QC Data to HC (1) Display the QC Chart screen of QC file that contains the data you want to output to the host computer. For how to select QC file, refer to Chapter 2.3: Select QC File in this chapter. (2) Using [ ] key or [ ] key, move the line cursor to the position of the data you want to output to HC. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:QC Analyze 2:Settings 3:Erase All LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-4-7: QC Chart Screen
  • 176. QUALITY CONTROL 5-36 Sysmex KX-21N Operator’s Manual -- October 1999 (3) Press [ENTER] key. The line cursor changes from dotted line to solid line, and the menu in the Menu Display Area changes over to "1: Delete," "2: Output," "3: RangeSpec.". NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the menu in the Menu Display Area change to the original status. • The line cursor that has changed to solid line cannot be moved. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:Delete 2:Output 3:RangeSpec. LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-4-8: QC Chart Screen (At Data Selection) (4) Press [3] key to select "3: RangeSpec.". Move the line cursor of the dotted line for range specification of the other end. (5) Using [ ] key or [ ] key, move the line cursor to the other end of the data within the output range. (N=30) UL WBC RBC HGB LL UL LL UL LL FILE No.1 [1234567890][07/11/1999] 31/10 1:Delete 2:Output 3:RangeSpec. LIMIT DATA (MEAN) 8.1 7.6 7.3 7.1( 7.8) 4.70 4.50 4.52 4.30( 4.55) 15.5 15.0 14.8 14.5( 15.0) Figure 5-4-9: QC Chart Screen (At Data Range Specification) (6) Press [ENTER] key. The line cursor changes from dotted line to solid line.
  • 177. QUALITY CONTROL Sysmex KX-21N Operator’s Manual -- October 1999 5-37 (7) Press [2] key to select "2: Output." The pop-up menu to select the output destination will appear. 1 : H o s t 2 : D P 3 : G P 4 : L P 5 : I P 6 : I P F e e d 7:StopOutput Figure 5-4-10: Pop-up Menu (8) Using [ ] key or [ ] key to move the cursor to [1: Host], and press [ENTER] key. QC data of the plot shown by the line cursor is output to the host computer. NOTE: • For the output format, refer to Appendix B: Technical Information. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 178. Sysmex KX-21N Operator’s Manual -- October 1999 N.A. CHAPTER 6 CALIBRATION 1. INTRODUCTION ................................................................. 6-1 1.1 Calibration ................................................................... 6-1 1.2 Calibrator Calibration Program............................................ 6-1 2. PREPARATION FOR CALIBRATION ........................................ 6-2 2.1 Precision Check ............................................................. 6-2 2.2 Precision Check Sample.................................................... 6-2 2.3 HGB/HCT Calibration Samples........................................... 6-3 2.4 Reference Values............................................................ 6-3 2.4.1 Calibrator Calibration.............................................. 6-3 2.4.2 HGB/HCT Calibration ............................................ 6-3 2.5 Calibration Flow Chart ..................................................... 6-4 3. AUTOMATIC CALIBRATION.................................................. 6-5 3.1 Executing Automatic Calibration Program ............................... 6-5 3.2 Automatic Calibration Procedure.......................................... 6-6 4. MANUAL CALIBRATION .....................................................6-11 4.1 Calculating Calibration Value.............................................6-11 4.2 Manual Calibration Procedure ............................................6-12 5. CALIBRATOR CALIBRATION ...............................................6-15 5.1 Executing Calibrator Calibration Program ..............................6-15 5.2 Calibrator Calibration Procedure .........................................6-17 6. CALIBRATION HISTORY PRINT............................................6-25
  • 179. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-1 1 . INTRODUCTION Upon installation of the KX-21N, the Sysmex trained service representative will perform instrument calibration. Calibration is required at installation, and then calibration is verified at least daily with QC material. This chapter covers procedures necessary to calibrate the instrument for WBC (white blood cell count), RBC (red blood cell count), HGB (hemoglobin), HCT (hematocrit) and PLT (platelet count). WBC differential parameters are calibrated at the factory prior to shipment and are verified by the Sysmex representative at installation. They do not need to be calibrated at the laboratory. 1.1 Calibration It is recommended that the laboratory performs calibration when any of the following occurs: • Major preventative maintenance has been performed or critical parts replaced such as manometers apertures or detector circuit boards. • Controls that reflect an unusual trend or are outside of acceptable limits, and cannot be corrected by maintenance or troubleshooting the instrument. • The Sysmex trained service representative has advised to calibration. 1.2 Calibrator Calibration Program Calibrate the WBC, RBC, HGB, HCT and PLT of the KX-21N using the SCS-1000 calibrator. The calibration program consists of the following two functions. (1) Precision Check Using fresh human blood, the instrument reproducibility is checked against manufacturer's specifications for precision. (2) Calibration Using the SCS-1000 calibrator, the instrument calibration is checked and recalibration is performed as required. NOTE: • Do not use EIGHTCHECK-3WP for calibration. It is used for quality control. Calibration should be performed at the room temperature within 25±5°C.
  • 180. CALIBRATION 6-2 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2 . PREPARATION FOR CALIBRATION 2.1 Precision Check Analyze a fresh human blood 11 times consecutively in the whole blood mode. The system program automatically discards the first analysis and calculates the precision (reproducibility) with the remaining 10 data. The following has to be verified prior to starting the precision check: • Transducer apertures are clog free. If not, perform the aperture cleaning procedures by referring to Chapter 4. • Check if the reagent volume in each reagent container is enough to complete the calibration procedure. • Check if the reagent is within the expiration date. • If a waste container is used, check if the waste container has enough room to complete the calibration procedure. • Check if the background values fall within the following ranges; WBC ≤ 0.3 x 103/µL RBC ≤ 0.02 x 106/µL HGB ≤ 0.1 g/dL PLT ≤ 10 x 103/µL 2.2 Precision Check Sample One sample of fresh normal whole blood should be used for the precision check. The sample should be analyzed within six hours of collection and stored at room temperature. Observe the following recommendations when selecting blood for precision check purposes. • The sample should be collected from a person who is not on medication. • The sample should be morphologically and numerically normal, as; WBC ≥ 4.00 x 103/µL RBC ≥ 4.00 x 106/µL PLT ≥ 100 x 103/µL • Lipemic, icteric, and hemolyzed specimens must be avoided. • The anticoagulant should be the proper type and in proportion with the sample. • The volume of whole blood per sample should be greater than 2 mL (smaller volumes may indicate poor sample collection and increase the risk of hemolysis or have incorrect anticoagulant proportions). NOTE: • Do not use the control blood for precision check. System program for the precision check is designed to analyze human blood.
  • 181. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-3 2.3 HGB/HCT Calibration Samples Five to ten samples of fresh normal whole blood should be used for the HGB/HCT calibration. The samples should be analyzed within six hours of collection and kept at room temperature. Observe the following recommendations when selecting blood for HGB/HCT calibration purposes. • Blood of a healthy person who is not taking any medicine • Blood added with appropriate anticoagulant • Per-sample whole blood volume to exceed 2 mL • HGB value to exceed 10.0 g/dL • HCT value to be within 35.5% - 55.5% NOTE: • For calibration, do not use EIGHTCHECK-3WP, which was not prepared for calibration but for the use as control blood. 2.4 Reference Values 2.4.1 Calibrator Calibration The Assay Target values provided for each calibrator will be the reference values for Calibrator calibration samples. 2.4.2 HGB/HCT Calibration Five or more normal blood samples prepared for calibration of HGB and HCT should be accurately analyzed three times each in accordance with the reference method. The measurements thus obtained are used as reference values. HGB values: Cyanmethemoglobin method HCT values: Microhematocrit method (Five samples are used for automatic calibration.) NOTE: • HGB reference value will be influenced by WBC count, diluent, lyse reagent, HGB light source, temperature, and etc. • HCT reference value decreases significantly due to excessive anticoagulant.
  • 182. CALIBRATION 6-4 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2.5 Calibration Flow Chart HGB/HCT calibration start Completion of HGB/HCT calibration Calibrator calibration start Analyze samples by the reference method to determine reference value (target value). Automatic calibration: 5 samples Manual calibration: Over 5 samples Completion of calibrator calibration Page 6-3 Automatic calibration Manual calibration Update calibration value. Page 6-14 Enter calibration value. Page 6-13 Select manual calibration program. Page 6-12 Calculate calibration value. Page 6-11 Analyze in whole blood mode. Page 6-11 Update calibration value. Page 6-24 Analyze in calibrator analysis mode. Page 6-22 Enter assay target value. Page 6-19 Precision check Page 6-17 Select calibrator calibration program. Page 6-15 Select automatic calibration program. Page 6-5 Select calibration parameter. 1: HGB 2: HGB and HCT 3: HCT Page 6-6 Enter target value. Analyze in whole blood mode. Page 6-8 Update calibration value. Page 6-10 Page 6-7
  • 183. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-5 3 . AUTOMATIC CALIBRATION In automatic calibration, five or more fresh, normal blood samples are used for automatic calibration of HGB and HCT values. 3.1 Executing Automatic Calibration Program (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "3: Calibration." (3) Press [ENTER] key. The Calibration Menu screen appears. *Calibration* 1:Auto Cal. 2:Manual Cal. 3:Calibrator 4:Print Rev. History Figure 6-3-1: Calibration Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "1: Auto Cal." (5) Press [ENTER] key. The Automatic Calibration Menu screen appears. *Auto Cal.* 1:HGB 2:HGB/HCT 3:HCT Figure 6-3-2: Automatic Calibration Menu Screen On the Automatic Calibration Menu screen, an automatic calibration parameter can be selected from among "1: HGB," "2: HGB/HCT," and "3: HCT." NOTE: • Each menu can be selected directly by entering a numeral from the numeric keys.
  • 184. CALIBRATION 6-6 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 3.2 Automatic Calibration Procedure 1 . Selecting Automatic Calibration Parameter (1) Using [ ] or [ ] key, move the cursor to select an automatic calibration parameter on the Automatic Calibration Menu Screen: [1: HGB]: Calibrates HGB alone. [2: HGB/HCT]: Calibrates two parameters of HGB and HCT at the same time. [3: HCT]: Calibrates HCT alone. NOTE: • Each menu can be selected directly by entering a numeral from the numeric keys. (2) Press [ENTER] key. The Automatic Calibration screen for the selected parameter appears. Target HGB 1 2 3 4 5 Data HGB Compensation HGB Current Cal.(%)100.0 New Cal.(%) *Auto Cal.* Press [SELECT] to Set. Figure 6-3-3: HGB Automatic Calibration Screen Target HGB HCT HCT HCT 1 2 3 4 5 Data HGB Compensation HGB Current Cal.(%)100.0 100.0 New Cal.(%) *Auto Cal.* Press [SELECT] to Set. Figure 6-3-4: HGB/HCT Automatic Calibration Screen
  • 185. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-7 Target HCT Current Cal.(%)100.0 New Cal.(%) 1 2 3 4 5 Data HCT Compensation HCT *Auto Cal.* Press [SELECT] to Set. Figure 6-3-5: HCT Automatic Calibration Screen 2 . Entering Target Values (1) Using the numeric keys, enter the HGB or HCT reference values obtained by the reference method in the target column. NOTE: • Press [C] key to delete one letter at a time. (2) Press [ENTER] key to fix the entered value and move the reverse display to the next target column. Target HGB 12.5 HCT HCT HCT Current Cal.(%)100.0 100.0 New Cal.(%) 1 2 3 4 5 Data HGB Compensation HGB *Auto Cal.* Press [SELECT] to Set. Figure 6-3-6: Entering Target Values NOTE: • After entering the 5th target value, pressing [ENTER] key does not move the reverse display to the next target column. • An entered value can be set also by pressing [ ] or [ ] key after entering the target value.
  • 186. CALIBRATION 6-8 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. (3) When all target values have been entered, press [SELECT] key. The Target Value Setting Confirmation message appears. OK to set? Cont. Set Cancel Figure 6-3-7: Target Value Setting Confirmation Message (4) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the status for entering target values. And the setting operation can be continued. [Set]: Sets target values and charges to the Sample Analysis Waiting status. [Cancel]: Cancels automatic calibration and returns to the Analysis screen. (5) Press [ENTER] key to execute the selected process. 3 . Analysis for Automatic Calibration (1) When the target values are set, the system turns to the Ready status for automatic calibration analysis. NOTE: • Automatic calibration analysis is performed in the whole blood mode. When the analysis mode is set in the pre-diluted mode, the mode changeover sequence is activated to switch to the whole blood mode. Target HGB 12.5 13.0 13.5 11.0 15.0 HCT 50.0 45.2 51.5 40.8 52.5 HCT *Auto Cal.* WB Ready HCT HCT 1 2 3 4 5 Data HGB Compensation HGB Current Cal.(%)100.0 100.0 New Cal.(%) Figure 6-3-8: Automatic Calibration Screen (Before Analysis) (2) Analyze the samples used for determining the standard value. The sample being analyzed is indicated by the underline cursor.
  • 187. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-9 (3) After completion of analysis, analysis result appears in the data column and compensation rate in the compensation column, then the underline cursor moves to the next sample. Upon completion of more than one sample, average compensation rate is automatically calculated and displayed at the bottom of the compensation column. Target HGB 12.5 13.0 13.5 11.0 15.0 HCT 50.0 45.2 51.5 40.8 52.5 HCT 48.0 43.9 50.0 95.6 103.4 HCT 104.2 103.0 103.0 1 2 3 4 5 Data HGB 13.0 13.7 14.1 Compensation HGB 96.2 94.9 95.7 WB*Auto Cal.* Ready Current Cal.(%)100.0 100.0 New Cal.(%) Figure 6-3-9: Automatic Calibration Screen (After Analysis) CAUTION: • When an error occurs during automatic calibration analysis, the error message appears in the system status display area. The result of analysis in which an error has occurred is masked with "---.-," which is not calculated for compensation rate and not used for average compensation rate calculation, either. • If "0" is input to the target value, compensation rate for the sample is not calculated and the analysis result is not used for average compensation rate calculation, either.
  • 188. CALIBRATION 6-10 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 4 . Updating Calibration Value (1) When all analyses are finished, press [SELECT] key. New compensation values will be calculated and the Calibration Value Change Confirmation message will appear. Change? Yes No Figure 6-3-10: Calibration Value Change Confirmation Message NOTE: • The new compensation value is calculated as follows: New compensation value (%) Current compensation value (%) × Average compensation rate (%) 100 = • When the compensation rate exceeds the following range, "Calibration Error" is displayed and the Calibration Value Change Confirmation message does not appear. Average compensation rate > 105% Average compensation rate < 95% New compensation value > 120% New compensation value < 80% *Auto Cal.* Calibration Error Figure 6-3-11: Calibration Error Message About calibration errors, refer to Chapter 7: TROUBLESHOOTING. (2) Using [ ] or [ ], move the cursor to select "YES" or "NO." [YES] : Updates the calibration value and returns to the Analysis screen. [NO] : Does not update the calibration value and returns to the Analysis screen. (3) Press [ENTER] key to execute the selected process.
  • 189. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-11 4 . MANUAL CALIBRATION In manual calibration, calculated calibration value can be entered using the numeric keys. 4.1 Calculating Calibration Value (1) Analyze more than five samples, each three times, by the reference method and average HGB, HCT, WBC, RBC and PLT values. (2) Gently mix the same samples sufficiently and analyze them in the whole blood mode. (3) When there is a difference between data gained by analysis with this instrument and the reference value gained by the reference method, use the following formula to calculate the new calibration value: = × [Example] Average of HGB values gained by the reference method = 15.6 g/dL Average of HGB values gained by this instrument = 15.5 g/dL Previous calibration value of HGB = 100.0% 100.0 × = 100.65 = 100.7%15.6 15.5 . . Therefore, the new calibration value of HGB needs to be set at 100.7%. This means that the calibration value increased 0.7%. New calibration value Previous calibration value Average of values gained by reference method Average of values gained by this instrument
  • 190. CALIBRATION 6-12 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 4.2 Manual Calibration Procedure (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "3: Calibration." (3) Press [ENTER] key. The Calibration Menu screen appears. *Calibration* 1:Auto Cal. 2:Manual Cal. 3:Calibrator 4:Print Rev. History Figure 6-4-1: Calibration Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "2: Manual Cal." (5) Press [ENTER] key. The Manual Calibration screen appears. HGB HCT WBC RBC PLT 100.0 100.0 100.0 100.0 100.0 *Manual Cal.* Press [SELECT] to Set. Figure 6-4-2: Manual Calibration Screen NOTE: • Each menu can be selected directly by entering a numeral from the numeric keys.
  • 191. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-13 1 . Entering Calibration Value (1) Using [ ] or [ ] key, move the cursor to select "HGB" or "HCT." (2) Using the numeric keys, enter the calibration value obtained by calculation. NOTE: • Press [C] key to delete one letter at a time. (3) Press [ENTER] key to set the entered value and move the reverse display to the next parameter. HGB HCT WBC RBC PLT 100.7 100.0 100.0 100.0 100.0 *Manual Cal.* Press [SELECT] to Set. Figure 6-4-3: Entering Calibration Value NOTE: • An entered value can be set also by pressing [ ] or [ ] key after entering the calibration value. • If no input is made or a space is input, it cannot be set.
  • 192. CALIBRATION 6-14 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2 . Updating Calibration Value (1) When all calibration values are entered, press [SELECT] key. The Calibration Value Change Confirmation message appears. Change? Yes No Figure 6-4-4: Calibration Value Change Confirmation Message NOTE: • When there is no calibration value changed, the Calibration Value Change Confirmation message is not displayed and the system returns to the Analysis screen. • When the compensation rate exceeds the following range, "Calibration Error" is displayed and the Calibration Value Change Confirmation message does not appear. Compensation rate = Average of values gained by reference method Average of values gained by this instrument X 100 Compensation rate > 105% Compensation rate < 95% New compensation value > 120% New compensation value < 80% *Manual Cal.* Calibration Error Figure 6-4-5: Calibration Error Message About calibration errors, refer to Chapter 7: TROUBLESHOOTING. (2) Using [ ] or [ ], move the cursor to select "YES" or "NO." [YES]: Updates the calibration value and returns to the Analysis screen. [NO]: Does not update the calibration value and returns to the Analysis screen. (3) Press [ENTER] key to execute the selected process.
  • 193. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-15 5 . CALIBRATOR CALIBRATION Calibrate the WBC, RBC, HGB, HCT and PLT using the SCS-1000 calibrator. 5.1 Executing Calibrator Calibration Program (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "3: CALIBRATION." (3) Press [ENTER] key. The Calibration Menu screen appears. *Calibration* 1:Auto Cal. 2:Manual Cal. 3:Calibrator 4:Print Rev. History Figure 6-5-1: Calibration Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "3: Calibrator." (5) Press [ENTER] key. The Precision Check screen appears. The Precision Check screen consists of 2 pages. Use the [ ] and [ ] keys to switch pages. Precision Check Screen 1: Displays analysis data. Precision Check Screen 2: Displays statistical values. The upper limits of the acceptable precision (reproducibility) values are displayed in the LMT(%) column for each parameter. NOTE: • Each menu can be selected directly by entering a numeral from the numeric keys.
  • 194. CALIBRATION 6-16 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. WBC RBC HGB HCT PLT *Preci.Check* WB Ready 1 2 3 4 5 6 7 8 9 10 Figure 6-5-2: Precision Check Screen 1 WBC RBC HGB HCT PLT *Preci.Check* WB Ready Mean SD CV(%) LMT(%) 3.5 2.0 1.5 2.0 6.0 Figure 6-5-3: Precision Check Screen 2
  • 195. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-17 5.2 Calibrator Calibration Procedure 1 . Precision Check (1) Analyze the sample in the whole blood mode. The sample being analyzed is indicated by the underline cursor. After the analysis is completed, the results will be displayed and the underline cursor will move to the next line. NOTE: • Precision check analysis is performed in the whole blood mode. When the analysis mode is set in the pre-diluted mode, the mode changeover sequence is activated to switch to the whole blood mode. WBC RBC HGB HCT PLT *Preci.Check* WB Analyzing 1 7.0 4.79 15.5 41.2 220 2 3 4 5 6 7 8 9 10 Figure 6-5-4: Precision Check Screen 1 (Analyzing) (2) When at least three analyses are complete, the average, the standard deviation (SD) and coefficient of variation (CV%) will be automatically calculated and displayed in the "Mean", "SD" and "CV(%)" columns, respectively. NOTE: • The first analysis data is not included in the calculation. The first analysis data is overwritten by the second analysis data. • When an error occurs during precision check analysis, the error message appears in the system status display area. The analysis result with an error is masked with "---.-." At this time, the underline cursor will not move to the next line and the next sample is analyzed using the same number.
  • 196. CALIBRATION 6-18 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. (3) Analyze the sample a total of 11 times. If the obtained CV(%) values for all five parameters are within the Precision Limit (CV%) values, the menu will be displayed in the menu display area. WBC RBC HGB HCT PLT *Preci.Check* WB Mean 6.9 4.82 14.0 40.9 212 SD 0.048 0.043 0.056 0.532 1.69 CV(%) 0.7 0.9 0.4 1.3 0.8 LMT(%) 3.5 2.0 1.5 2.0 6.0 1:Calibration 3:Cancel Figure 6-5-5: Precision Check Passed Screen (4) Using the numeric keys, select "1: Calibrate" or "3: Cancel." [1: Calibrate]: The SCS-1000 Analyzing Calibrator screen appears. [3: Cancel]: Returns to the Analysis screen. If any of the obtained CV(%) values exceed the LMT (%) value, the CV (%) value will be reverse display and the "1: Calibrate" menu will not be displayed. Refer to Chapter 7 "Troubleshooting" and take corrective action. If assistance is required, contact a Sysmex service representative. WBC RBC HGB HCT PLT *Preci.Check* WB Mean 6.90 4.82 15.1 40.9 212 SD 0.255 0.043 0.056 0.532 1.69 CV(%) 3.7 0.9 0.4 1.3 0.8 LMT(%) 3.5 2.0 1.5 2.0 6.0 3:Cancel Figure 6-5-6: Precision Check Failed Screen
  • 197. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-19 2 . Entering Target Values To perform calibrator calibration, you must enter the Assay Target values exactly as provided with the Sysmex SCS-1000 Calibrator product. Verify that the assay sheet matches the Lot # of calibrator. (1) When the precision check is completed and "1: Calibration" is selected, the Analyzing Calibrator screen appears. The Analyzing Calibrator screen consists of 2 pages. Use the [ ] and [ ] keys to switch pages. Analyzing Calibrator Screen 1: Displays the Target values and analysis data. Analyzing Calibrator Screen 2: Displays statistical values. When the Analyzing Calibrator screen 1 is displayed, the area to input the WBC Target value is reverse display. *Calibrator* Target 0 1 2 3 4 5 Press [SELECT] to Set. WBC RBC HGB HCT PLT Figure 6-5-7: Analyzing Calibrator Screen 1 WBC RBC HGB HCT PLT *Calibrator* Range V. MaxRange 0.7 0.20 0.5 1.8 35 Mean V. Delta% ACPT LMT 3.95 1.54 0.76 2.21 3.53 SERV LMT 14.00 5.00 5.00 5.00 15.00 Current 102.1 99.9 101.6 98.4 100.4 New Figure 6-5-8: Analyzing Calibrator Screen 2
  • 198. CALIBRATION 6-20 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. Explanation of Displayed Items Target : Assay Target values provided with calibrator are entered. Range V. : The highest value minus the lowest value within five consecutive analyses is displayed. MaxRange : The maximum Range Value allowed is automatically calculated from the Assay Target and displayed. Mean V. : Mean value of five consecutive analysis results. Delta% : Assay Target - Mean Value Mean Value x 100 (%) is automatically calculated and displayed. ACPT LMT : Maximum Upper Limit of Delta Percent (%). Calibration is not necessary when the Delta Percent is within this limit. SERV LMT : If the Delta Percent exceeds this limit, technical assistance may be necessary and your instrument system needs service. Calibration will not be allowed. Current : Current calibration value, which was obtained in the previous calibration procedure. New : New calibration value calculated from the calibrator analysis. (2) Using the numerical keys, enter the assay target value exactly for the WBC parameter. Press [Enter] key, and the input value is displayed in the "Target" column. The reverse display then moves to the next parameter. Enter the assay target values for all 5 parameters. *Calibrator* Target 7.0 0 1 2 3 4 5 Press [SELECT] to Set. WBC RBC HGB HCT PLT Figure 6-5-9: Entering Target Value NOTE: • Press [C] key to delete entirely.
  • 199. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-21 (3) When the assay target values for all five parameters are entered, make sure once again the entered values are correct with the Assay Sheet. If correction is required, select the parameter using the [ ] and [ ] keys, and enter the correct value. *Calibrator* Target 7.0 4.80 15.0 40.8 220 0 1 2 3 4 5 WBC RBC HGB HCT PLT Press [SELECT] to Set. Figure 6-5-10: Verifying Target Value Screen (4) When all assay target values have been entered, press [SELECT] key. The Target values setting confirmation message appears. OK to set? Cont. Set Cancel Figure 6-5-11: Target Value Setting Confirmation Message (5) Using [ ] and [ ] key, move the cursor to select "Cont.", "Set" or "Cancel." [Cont.]: Returns to the status for entering assay target values. And the setting operation can be continued. [Set]: Sets assay target values and charges to the calibrator analysis waiting status. [Cancel]: Cancels calibrator calibration and returns to the Analysis screen. (6) Press [ENTER] key to execute the selected process.
  • 200. CALIBRATION 6-22 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 3 . Analysis for Calibrator Calibration (1) When the target values are set, the system turns to the Ready status for calibrator analysis. NOTE: • Calibrator analysis is performed in the whole blood mode. When the analysis mode is set in the pre-diluted mode, the mode changeover sequence is activated to switch to the whole blood mode. In the whole blood mode, "CL" in the calibrator analysis mode is displayed in the system status display area. *Calibrator* Target 7.0 4.80 15.0 40.8 220 0 1 2 3 4 5 WBC RBC HGB HCT PLT CL Ready Figure 6-5-12: Analyzing Calibrator Screen 1 (1) *Calibrator* Target 7.0 4.80 15.0 40.8 220 0 6.9 4.77 15.3 40.8 214 1 2 3 4 5 WBC RBC HGB HCT PLT CL Analyzing Figure 6-5-13: Analyzing Calibrator Screen 1 (2) (2) When an analysis is complete, the results will be displayed and the underline cursor will move to the next line. (3) When the six analysis data are completed, "Range V.", "Mean V.", "Delta%" and "New" will begin to be automatically calculated and displayed in their respective columns.
  • 201. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-23 NOTE: • The first analysis data is not included in the calculation. • When an error occurs during calibrator analysis, the error message appears in the system status display area. The analysis result with an error is masked with "---.-" or "***.*". At this time, the underline cursor will not move to the next line and the next sample is analyzed using the same number. *Calibrator* Target 7.0 4.80 15.0 40.8 220 0 6.9 4.77 15.3 40.8 214 1 6.9 4.82 15.1 40.2 210 2 7.0 4.79 14.9 41.3 213 3 7.0 4.89 15.1 41.4 212 4 7.0 4.88 15.0 41.5 211 5 7.0 4.78 15.1 41.4 213 WBC RBC HGB HCT PLT Figure 6-5-14: Analyzing Calibrator Screen 1 WBC RBC HGB HCT PLT *Calibrator* Range V. 0.1 0.12 0.4 1.3 4 MaxRange 0.7 0.20 0.5 1.8 35 Mean V. 6.9 4.83 15.0 41.2 212 Delta% 0.03 0.66 0.27 0.87 3.87 ACPT LMT 3.95 1.54 0.76 2.21 3.53 SERV LMT 14.00 5.00 5.00 5.00 15.00 Current 102.1 99.9 101.6 98.4 100.4 New 102.1 99.9 101.6 98.4 104.2 Figure 6-5-15: Analyzing Calibrator Screen 2
  • 202. CALIBRATION 6-24 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. If the Range values exceed the MaxRange values, the Range value will be reverse display. If the Delta% values exceed SERV LMT values, the Delta% value will be reverse display. Calibration will not be allowed. WBC RBC HGB HCT PLT *Calibrator* Range V. 0.1 0.12 0.6 1.3 4 MaxRange 0.7 0.20 0.5 1.8 35 Mean V. 6.9 4.83 15.0 41.2 212 Delta% 0.03 4.66 0.27 0.87 3.87 ACPT LMT 3.95 1.54 0.76 2.21 3.53 SERV LMT 14.00 5.00 5.00 5.00 15.00 Current 102.1 99.9 101.6 98.4 100.4 New 102.1 99.9 101.6 98.4 104.2 Figure 6-5-16: Rang V. > MaxRange or Delta% > SERV LMT Screen 1) When there are: Range V. > MaxRange or Delta% > SERV LMT or Delta% ACPT LMT, New = Current 2) Other than above, New = (Target/Mean V.) × Current 4 . Updating Calibration Value (1) After the statistical values are calculated, press [SELECT] key. New compensation values will be calculated and the Calibration Value Change Confirmation message will appear. Change? Yes No Figure 6-5-17: Calibration Value Change Confirmation Message (2) Using [ ] or [ ], move the cursor to select "Yes" or "No." [Yes] : Updates the calibration value and returns to the Analysis screen. [No] : Does not update the calibration value and returns to the Analysis screen. (3) Press [ENTER] key to execute the selected process.
  • 203. CALIBRATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 6-25 6 . CALIBRATION HISTORY PRINT Using this menu, a recent five times calibration history can be printed from the built-in printer. Execution of Calibration History Print (1) Press [SELECT] key in the Ready status. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "3: Calibration." (3) Press [ENTER] key. The Calibration Menu screen appears. *Calibration* 1:Auto Cal. 2:Manual Cal. 3:Calibrator 4:Print Rev. History Figure 6-6-1: Calibration Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "4: Print Rev. History." (5) Press [ENTER] key. The built-in printer prints the calibration history. Print Example .... Date 31/10/1999 Time 10:23 *Cal.History* Date 29/10/1999 Time 08:23 HGB 95.6 HCT 103.4 Date 30/10/1999 Time 08:23 HGB 99.3 HCT 101.2 Figure 6-6-2: Calibration History Print Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.
  • 204. Sysmex KX-21N Operator’s Manual -- October 1999 CHAPTER 7 TROUBLESHOOTING 1. INTRODUCTION................................................................. 7-1 2. WHEN YOU SUSPECT A TROUBLE ........................................7-2 2.1 Alphabetical List of Error Messages Displayed on Analysis Screen ............................................7-3 2.2 Alphabetical List of Error Messages Displayed on HELP Screen ....7-4 2.3 Functional List of Error Messages .......................................7-5 3. TROUBLESHOOTING GUIDE ................................................7-7 3.1 Pressure/Vacuum Errors...................................................7-7 3.2 Chamber Errors........................................................... 7-10 3.3 Motor Errors .............................................................. 7-13 3.4 Transducer Errors ........................................................ 7-15 3.5 Temperature Errors....................................................... 7-16 3.6 Analysis Errors ........................................................... 7-17 3.7 Memory Errors ........................................................... 7-23 3.8 Others...................................................................... 7-25 3.9 Maintenance Errors....................................................... 7-27 3.10 Printer Errors ............................................................. 7-30 3.11 External Device Errors................................................... 7-33 4. STATUS DISPLAY............................................................. 7-34 5. ERROR HISTORY PRINT .................................................... 7-36 6. PROGRAM VERSION ......................................................... 7-37
  • 205. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-1 1 . INTRODUCTION If the running instrument develops any symptom that you suspect to be a trouble, check it making reference to "2. WHEN YOU SUSPECT A TROUBLE" which begins from the next page. When there is not any item that confirms to the trouble in question or if "Action" fails to eliminate the symptom, contact your Sysmex service representative for assistance. When a trouble occurs, the instrument displays an error message on the LCD screen. When there occurs an error unique to a sample analyzed, analysis data is displayed with a flag. This chapter describes the cause of a trouble on which an error message is displayed, along with actions that the customer can take in checking and repairing. HELP Function When a trouble has occurred, the warning alarm sounds and an error message is displayed on the screen. By pressing [HELP] key on the panel keyboard, you can stop the alarm and change over to the HELP screen that shows what action to take against the error. Supplementary explanation for that function is given here. In the event multiple errors occur at the same time, press [HELP] key. The errors that have occurred are listed in the order from higher priority. *Help* Multiple errors occurred. Pressure/Vac Error Rinse Motor Error Waste Not Draining Sampling Error Room Temp. High Press[HELP] for more information. Figure 7-1-1: Help Screen (Error List) Press [HELP] key again. The screen changes to the HELP screen for the error listed at top. NOTE: • When you contact your Sysmex service representative, inform him of "ERR CODE" given on the HELP screen. By doing so, you can inform him of the instrument's status easier and more correctly. • When you repair in accordance with TROUBLESHOOTING, be sure to turn the power OFF except when you have to confirm displays and instructions on the screen. If you repair with the power turned ON, you have a risk of electric shock hazard and you may give a permanent damage to electric parts. WARNING
  • 206. TROUBLESHOOTING 7-2 Sysmex KX-21N Operator’s Manual -- October 1999 2 . WHEN YOU SUSPECT A TROUBLE 1. Turning the power ON does not start the unit. • Is the power cord connected securely? • Isn't the fuse blown? Refer to Chapter 4, Section 8.2: Replace Fuse. • Is the power supplied to AC outlet? 2. When the power is ON, nothing is displayed and "beep" keeps sounding. • There is a possibility that memory error has occurred. Turn OFF the power, and turn it ON again 1 - 2 minutes later. 3. The screen displays nothing. • Isn't LCD brightness properly adjusted? Refer to Chapter 1, Section 8.3: LCD Brightness Adjustment. 4. The screen displays "PU Sleeping" message and no key entry is accepted. • Timer mode turned OFF the pneumatic unit power. To return the instrument to the ready status, press the [SELECT] key to return to the analysis result screen, and then the [Start] switch. 5. Fluid leaks from the unit. • Turn OFF the power and wipe off leaking fluid. If fluid leakage persists after turning ON the power, contact your Sysmex service representative. 6. Data has error. • Check QC data of control blood. • Referring to Chapter 4: INSTRUMENT MAINTENANCE AND SUPPLIES REPLACEMENT, conduct the maintenance below: Chapter 4, Section 5.2: Clean Transducer Chapter 4, Section 6.1: Clean SRV 7. An error occurs. Search the following message lists for an error in question and refer to the corresponding pages in TROUBLESHOOTING: 1) Message List To search the pages, the error messages are listed in "Alphabetical" and "Functional" orders. 2) TROUBLESHOOTING Cause and action for each trouble are described for respective error message. • When operating, always wear rubber gloves. After completion of work, wash hands with disinfectant. If your hands are contaminated by blood, etc., infection of bacteria can result. WARNING
  • 207. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-3 2.1 Alphabetical List of Error Messages Displayed on Analysis Screen [A] Abnormal DP (when data printer is incorporated)---------------------------------------------- 7-31 Abnormal GP (when graphic printer is incorporated)-----------------------------------7-31, 7-32 Abnormal IP ---------------------------------------------------------------------------------7-30, 7-32 Analysis Error -------------------------------------------------------------------------------7-21, 7-22 [B] Background Error ----------------------------------------------------------------------------------7-17 [C] Calibration Error------------------------------------------------------------------------------------7-26 Clean SRV. -----------------------------------------------------------------------------------------7-27 Clean Transducer-----------------------------------------------------------------------------------7-29 Clean Waste Chamber. ----------------------------------------------------------------------------7-28 [H] HGB Error ------------------------------------------------------------------------------------------7-20 Host Comm. Error ---------------------------------------------------------------------------------7-33 [M] Momentary Power Failure-------------------------------------------------------------------------7-24 Memory Error---------------------------------------------------------------------------------------7-23 [P] Pressure/Vac Error ----------------------------------------------------------------------- 7-7, 7-8, 7-9 [Q] QC Error---------------------------------------------------------------------------------------------7-25 [R] RBC Aperture Clog --------------------------------------------------------------------------------7-15 Replenish Diluent-----------------------------------------------------------------------------------7-11 Replenish Lyse -------------------------------------------------------------------------------------7-12 Rinse Motor Error---------------------------------------------------------------------------7-13, 7-14 Room Temp. High ---------------------------------------------------------------------------------7-16 Room Temp. Low----------------------------------------------------------------------------------7-16 [S] Sampling Error ------------------------------------------------------------------------------7-18, 7-19 Set Value Error ------------------------------------------------------------------------------7-23, 7-24 [W] Waste Not Draining --------------------------------------------------------------------------------7-10 WBC Aperture Clog -------------------------------------------------------------------------------7-15 Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 208. TROUBLESHOOTING 7-4 Sysmex KX-21N Operator’s Manual -- October 1999 2.2 Alphabetical List of Error Messages Displayed on HELP Screen 0.05 MPa Pressure Error----------------------------------------------------------------------------7-7 0.05 MPa Pressure Error at count------------------------------------------------------------------7-9 0.0333 MPa Vacuum Error -------------------------------------------------------------------------7-8 [A] Abnormal detection sensitivity-------------------------------------------------------------------- 7-22 [B] Background count exceeds tolerance.------------------------------------------------------------ 7-17 [C] Calibration value is out of range. ----------------------------------------------------------------7-26 Clean the SRV. -------------------------------------------------------------------------------------7-27 Clean the Transducer. ----------------------------------------------------------------------------7-29 Clean the Waste Chamber. ----------------------------------------------------------------------- 7-28 Clog in the aperture (RBC)------------------------------------------------------------------------7-15 Clog in the aperture (WBC)----------------------------------------------------------------------- 7-15 [D] DP printout error (when data printer is incorporated)------------------------------------------ 7-31 [E] Error has occurred during counting (PLT). ---------------------------------------------------- 7-18 Error has occurred during counting (RBC). ---------------------------------------------------- 7-18 Error has occurred during counting (WBC).---------------------------------------------------- 7-18 Error occurred during HGB analysis. ----------------------------------------------------------- 7-20 Error on IP ------------------------------------------------------------------------------------------7-30 Error on Rinse Cup -------------------------------------------------------------------------7-13, 7-14 [G] GP paper empty (when graphic printer is incorporated)--------------------------------------- 7-32 GP printout error (when graphic printer is incorporated)-------------------------------------- 7-31 [H] Host Output Error ----------------------------------------------------------------------------------7-33 [I] IP paper empty--------------------------------------------------------------------------------------7-32 [M] Memory error occurred. (Repairing) ------------------------------------------------------------ 7-23 Memory error occurred. (Turn OFF then ON the power.) ----------------------------7-23, 7-24 Momentary power failure occurred.-------------------------------------------------------------- 7-24 [Q] QC data falls out of control limits. --------------------------------------------------------------- 7-25 [R] Replenish Diluent Container. --------------------------------------------------------------------- 7-11 Replenish Lyse Container. ----------------------------------------------------------------------- 7-12 Room Temp. Error --------------------------------------------------------------------------------7-16 [S] Sampling Error has occurred. -------------------------------------------------------------------- 7-19 [W] Waste Not Drained ---------------------------------------------------------------------------------7-10 WBC/HGB Analysis Error------------------------------------------------------------------------7-21 Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 209. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-5 2.3 Functional List of Error Messages NOTE: • [ ] indicates error naming that is displayed on the Analysis screen. 1 . Pressure/Vacuum Errors 0.05 MPa Pressure Error [Pressure/Vac Error]-------------------------------------------7-7 0.0333 MPa Vacuum Error [Pressure/Vac Error] ----------------------------------------7-8 0.05 MPa Pressure Error at count [Pressure/Vac Error] ---------------------------------7-9 2 . Chamber Errors Waste Not Drained [Waste Not Draining]----------------------------------------------- 7-10 Replenish Diluent Container. [Replenish Diluent]-------------------------------------- 7-11 Replenish Lyse Container. [Replenish Lyse] ------------------------------------------- 7-12 3 . Motor Errors Error on Rinse Cup [Rinse Motor Error]-----------------------------------------7-13, 7-14 4 . Aperture Errors Clog in the aperture (WBC) [WBC Aperture Clog]------------------------------------ 7-15 Clog in the aperture (RBC) [RBC Aperture Clog] ------------------------------------- 7-15 5 . Temperature Errors Room Temp. Error [Room Temp. High]------------------------------------------------ 7-16 Room Temp. Error [Room Temp. Low] ------------------------------------------------ 7-16 6 . Analysis Errors Background count exceeds tolerance. [Background Error] --------------------------- 7-17 Error has occurred during counting. (PLT) [Sampling Error] ------------------------ 7-18 Error has occurred during counting. (RBC) [Sampling Error] ----------------------- 7-18 Error has occurred during counting. (WBC) [Sampling Error]----------------------- 7-18 Sampling Error has occurred. [Sampling Error]---------------------------------------- 7-19 Error occurred during HGB analysis. [HGB Error] ----------------------------------- 7-20 WBC/HGB Analysis Error [Analysis Error]-------------------------------------------- 7-21 Abnormal detection sensitivity [Analysis Error]---------------------------------------- 7-22 7 . Memory Errors Memory error occurred. (Turn OFF then ON the power.) [Memory Error]-------- 7-23 Memory error occurred. (Repairing) [Set Value Error]-------------------------------- 7-23 Memory error occurred. (Turn OFF then ON the power.) [Set Value Error] ------ 7-24 Momentary power failure occurred. [-]-------------------------------------------------- 7-24 8 . Others QC data falls out of control limits. [QC Error]------------------------------------------ 7-25 Calibration value is out of range. [Calibration Error] ---------------------------------- 7-26 Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 210. TROUBLESHOOTING 7-6 Sysmex KX-21N Operator’s Manual -- October 1999 9 . Maintenance Errors Clean the SRV. [Clean SRV.] ------------------------------------------------------------ 7-27 Clean the Waste Chamber. [Clean Waste Chamber.] ---------------------------------- 7-28 Clean the Transducer. [Clean Transducer.] --------------------------------------------- 7-29 1 0 . Printer Errors Error on IP [Abnormal IP]-----------------------------------------------------------------7-30 GP printout error [Abnormal GP]--------------------------------------------------------- 7-31 DP printout error [Abnormal DP] --------------------------------------------------------- 7-31 IP paper empty [Abnormal IP] ------------------------------------------------------------ 7-32 GP paper empty [Abnormal GP]---------------------------------------------------------- 7-32 1 1 . External Option Errors Host Output Error [Host Comm. Error]------------------------------------------------- 7-33
  • 211. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-7 3 . TROUBLESHOOTING GUIDE 3.1 Pressure/Vacuum Errors Error Message Meaning of Message "Pressure/Vac Error" 0.034 [0.039 - 0.059] ERR CODE:XXXXX.X.X *Help* 0.05 MPa Pressure Error Adjust 0.05 MPa Pressure. Restarting to monitor the pressure 1:End of Adj [1] 0.05 MPa is out of the monitor range in Ready status. Monitor range: 0.039 - 0.059 MPa Cause 1) 0.05 MPa pressure adjustment error 2) Pneumatic unit pressure error 3) Air leakage from pressure line Action 1) Adjust Pressure to 0.05 MPa. The HELP screen displays pressure value in real time. Adjust pressure referring to Chapter 8, Section 2.3: Adjusting Pressure to 0.05 MPa. 2) Check Pressure Line Check the pressure line for loosened nipple or tube, or breakage. If any abnormality is noted, reconnect or replace. After adjustment or check, press [1] key to return to the original screen. Analysis after error occurrence Not Ready until the error is resolved. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 212. TROUBLESHOOTING 7-8 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message Meaning of Message "Pressure/Vac Error" ERR CODE:XXXXX.X.X *Help* 0.0333 MPa Vacuum Error Adjust 0.0333 MPa Vacuum. Restarting to monitor the vacuum[1] 1:End of Adj 0.0287 [0.0307 - 0.0360] 0.0333 MPa vacuum is out of the monitor range in Ready status. Monitor range: 0.0307 - 0.0360 MPa Cause 1) 0.0333 MPa vacuum adjustment error 2) Fluid back-flows into the trap chamber. 3) Pneumatic unit vacuum error 4) Air leakage from vacuum line Action 1) Adjust Vacuum to 0.0333 MPa The HELP screen displays vacuum value in real time. Adjust vacuum referring to Chapter 8, Section 2.4: Adjusting Vacuum to 0.0333 MPa. 2) Discard fluid in Trap Chamber Discard fluid if collected. Refer to Chapter 4, Section 3.2: Check Trap Chamber Level and Discard. 3) Check Vacuum Line Check the vacuum line for loosened nipple or tube, or breakage. If any abnormality is noted, reconnect or replace. After adjustment or check, press [1] key to return to the original screen. Analysis after error occurrence Not Ready until the error is resolved. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 213. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-9 Error Message Meaning of Message "Pressure/Vac Error" ERR CODE:XXXXX.X.X *Help* 0.05 MPa Pressure Error at count Turn OFF then ON the power. 3:Ana.Screen 0.05 MPa pressure is out of the monitor range during analysis. Monitor range: 0.029 - 0.069 MPa Cause 1) 0.05 MPa pressure adjustment error 2) Pneumatic unit pressure error 3) Air leakage from pressure line Action 1) Adjust Pressure to 0.05 MPa Turn the power OFF, and turned it ON again. Then adjust pressure referring to Chapter 8, Section 2.3: Adjust 0.05 MPa Pressure. 2) Check Pressure Line Check the pressure line for loosened nipple or tubing, or breakage. If any abnormality is noted, reconnect or replace. After adjustment or check, press [1] key to return to the original screen. Analysis after error occurrence The power needs to be turned OFF then ON again. NOTE: • Press [3] key to return to the Analysis screen. The status is not ready for analysis, but the processing, etc. of stored data in Select Menu can be performed. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 214. TROUBLESHOOTING 7-10 Sysmex KX-21N Operator’s Manual -- October 1999 3.2 Chamber Errors Error Message Meaning of Message "Waste Not Draining" ERR CODE:XXXXX.X.X Waste Not Drained Check kinked or blocked tubings. Retrying to drain the waste *Help* 3:Cancel1:Draining [1] Waste in the waste chamber can not be drained within the prescribed draining time. Cause 1) Breakage or clogging of waste chamber or waste line tube 2) Pneumatic unit pressure error 3) Air leakage from pressure line 4) Float switch malfunction 5) Faulty operation of solenoid or master valve Action 1) Check Waste Line Tube Check the waste drain line for breakage, clogging, etc. If any abnormality is present, clean or replace the tube. Specially check for contaminant or clogging near the drain outlet nipple. 2) Check Pressure Line Check the pressure line for loosened nipple or tubing, or breakage. If any abnormality is noted, reconnect or replace. After adjustment or check, press [1] key to return to the original screen. Analysis after error occurrence Not Ready until the error is resolved. NOTE: • Press [3] key to return to the Analysis screen. The status is not ready for analysis, but the processing, etc. of stored data in Select Menu can be performed.
  • 215. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-11 Error Message Meaning of Message "Replenish Diluent" ERR CODE:XXXXX.X.X *Help* 1:Asp. Reag. 3:Cancel Replenish Diluent Container. Reaspirating Diluent[1] Diluent (CELLPACK) can not be aspirated within the prescribed diluent aspiration time. Cause 1) Lack of diluent (CELLPACK) 2) Diluent aspiration line error 3) Air leakage from vacuum line 4) Float switch malfunction 5) Faulty operation of solenoid valve or master valve Action 1) Replenish Diluent (CELLPACK) If there is no diluent, replenish with a new diluent container. 2) Check Tube Check the diluent line tubing for breakage and the nipple for looseness. If any abnormality is noted, reconnect or replace. After replenishment or check, press [1] to return to the original screen. 3) Check Vacuum Line Check the vacuum line for breakage and loosened nipple or tubing. Analysis after error occurrence Not Ready until the error is resolved. NOTE: • Press [3] key to return to the Analysis screen. The status is not ready for analysis, but the processing, etc. of stored data in Select Menu can be performed.
  • 216. TROUBLESHOOTING 7-12 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message Meaning of Message "Replenish Lyse" ERR CODE:XXXXX.X.X *Help* 1:Asp. Reag. 3:Cancel Replenish Lyse Container. Reaspirating Lyse[1] No lyse remains. Cause 1) Lack of lyse (STROMATOLYSER-WH) 2) Float switch malfunction Action 1) Replenish Lyse (STROMATOLYSER-WH) When no lyse is left, replenish with a new lyse container. After replenishment or check, press [1] key to return to the original screen. Analysis after error occurrence Not Ready until the error is resolved. NOTE: • Press [3] key to return to the Analysis screen. The status is not ready for analysis, but the processing, etc. of stored data in Select Menu can be performed.
  • 217. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-13 3.3 Motor Errors Error Message Meaning of Message "Rinse Motor Error" ERR CODE:XXXXX.X.X *Help* Error on Rinse Cup Turn OFF then ON the power. If Rinse Cup is out of position, Turn power OFF and correct manually. 3:Ana.Screen The rinse cup is at lower position at start-up (This happens only when the power is ON.) Cause 1) Rinse cup drive motor malfunction 2) The power was turned ON with the rinse cup remaining lowered. Action 1) Turn OFF the power, manually raise the rinse cup with both hands to the original top position, then turn ON the power. Analysis after error occurrence The power needs to be turned OFF then ON again. NOTE: • Press [3] key to return to the Analysis screen. The status is not ready for analysis, but the processing, etc. of stored data in Select Menu can be performed.
  • 218. TROUBLESHOOTING 7-14 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message Meaning of Message "Rinse Motor Error" ERR CODE:XXXXX.X.X *Help* Error on Rinse Cup Turn OFF then ON the power. 3:Ana.Screen The rinse cup is not operating normally. Cause 1) Rinse cup drive motor malfunction 2) Error of the rinse cup drive motor controller Faulty operation of CPU due to sudden noise interference, etc. Action 1) Turn OFF the power and check to see that tubing, etc. are not in contact with the top or bottom of rinse cup. 2) Turn OFF the power and clean the rinse cup. Refer to Chapter 4, Section 7.2: Clean Rinse Cup. Analysis after error occurrence The power needs to be turned OFF then ON again. NOTE: • Press [3] key to return to the Analysis screen. The status is not ready for analysis, but the processing, etc. of stored data in Select Menu can be performed.
  • 219. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-15 3.4 Transducer Errors Error Message Meaning of Message "WBC Aperture Clog" "RBC Aperture Clog" Clog in the aperture Parameter: WBC RBC 1 Execute clog removal sequence. If clog persists, press[SELECT],then [Maintenance]->[Clean Transducer] or dab with brush after [SELECT], [Maintenance]->[Drain TD Chamber] ERR CODE:XXXXX.X.X 1:Clog Remove *Help* 3:Cancel The monitor value for aperture clog is out of the prescribed range. Cause 1) Transducer aperture clogging Action 1) Remove Aperture Clogging. Press [1] key to execute automatic clog removal sequence. 2) Transducer Rinse Sequence Pour 1 mL each of CELLCLEAN in the transducer chamber to perform auto rinse sequence. Refer to Chapter 4, Section 5.2: Clean Transducer. 3) Clean the Transducer with Brush Clean the aperture with brush. Refer to Chapter 4, Section 7.3: Clean WBC/RBC Transducer Aperture. Analysis after error occurrence Ready for analysis (although the next sample could be affected) NOTE: • Press [3] key to return to the Analysis screen. Although the system is ready for analysis, the error may occur in the next analysis.
  • 220. TROUBLESHOOTING 7-16 Sysmex KX-21N Operator’s Manual -- October 1999 3.5 Temperature Errors Error Message Meaning of Message "Room Temp. High" "Room Temp. Low" ERR CODE:XXXXX.X.X *Help* Room Temp.Error Analysis data has lower reliability. Check the room temperature. 41.5˚C [10.0 - 40.0] 3:Return Temperature in the unit (around the transducer) is out of the monitor range. Monitor range: 10.0 - 40.0°C Cause 1) Temperature in the transducer is high (or low.) Action 1) Check the Ambient Temperature Check to see that the ambient temperature is between 15°C - 30°C. Analysis after error occurrence Ready for analysis (although the next sample could be affected) NOTE: • Press [3] key to return to the Analysis screen. Although the system is ready for analysis, the error may occur in the next analysis.
  • 221. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-17 3.6 Analysis Errors Error Message Meaning of Message "Background Error" Background count exceeds tolerance. WBC 0.1 [<=0.3] (×103/µL) RBC 0.05 [<=0.02](×106/µL) HGB 0.0 [<=0.1] (g/dL) PLT 12 [<=10] (×103/µL) ERR CODE:XXXXX.X.X *Help* 3:Cancel1:Auto Rinse Suspected a dirty aperture or SRV. Execute an Auto Rinse.[1] In Auto Rinse, background check reveals that the background count of any parameter exceeds the tolerance. Tolerance: WBC 0.3×103 /µL or less RBC 0.02×106 /µL or less HGB 0.1g/dL or less PLT 10×103 /µL or less Cause 1) Dirty aperture 2) Dirty HGB flow cell 3) Bubbles mixing 4) Faulty reagent Action 1) Auto Rinse Press [1] key to perform Auto Rinse. 2) Clean Transducer Refer to Chapter 4, Section 5.2: Clean Transducer or Chapter 4, Section 7.3: Clean WBC/RBC Transducer Aperture. 3) Clean SRV Refer to Chapter 4, Section 6.1: Clean Sampling Valve (SRV). 4) Replenish Reagent Faulty lyse will affect background for WBC or HGB. In case diluent is faulty, it will affect all parameters, notably PLT background count. Analysis after error occurrence Ready for analysis (although the next sample could be affected) NOTE: • Press [3] key to return to the Analysis screen. Although the system is ready for analysis, the error may occur in the next analysis.
  • 222. TROUBLESHOOTING 7-18 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message Meaning of Message "Sampling Error" ERR CODE:XXXXX.X.X Execute clog removal sequence. If clog persists, press[SELECT], then [Maintenance]->[Clean Transducer] or dab with brush after [SELECT] [Maintenance]->[Drain T.D.Chamber] [1] 1:Clog Remove *Help* Error has occurred during counting. Parameter: WBC PLT Suspected a clogged aperture. 3:Cancel Sampling data falls into disorder. Sampling data refers to the count taken every 0.5 seconds during counting. The system monitors the counts. Cause 1) Dirty aperture 2) Effect of external noise interference Action 1) Clean Transducer 1. Remove Aperture Clogging Press [1] key to execute automatic clog removal sequence. 2. Transducer Rinse Sequence Pour 1 mL each of CELLCLEAN in the transducer chamber to perform auto rinse sequence. Refer to Chapter 4, Section 5.2: Clean Transducer. 3. Clean the Transducer with Brush Clean the aperture using brush. Refer to Chapter 4, Section 7.3: Clean WBC/RBC Transducer Aperture. 2) Remove Source of External Noise Move the noise source away from the unit. Analysis after error occurrence Ready for analysis (although the next sample could be affected) NOTE: • Press [3] key to return to the Analysis screen. Although the system is ready for analysis, the error may occur in the next analysis.
  • 223. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-19 Error Message Meaning of Message "Sampling Error" ERR CODE:XXXXX.X.X *Help* Sampling Error has occurred. 3:Retuen Sampling data falls into disorder. Sampling data refers to the count taken every 0.5 seconds during counting. The system monitors the counts taken. Cause 1) CPU malfunction due to sudden noise interference, etc. Action 1) Turn OFF then ON the power again. If the error persists after turning ON the power again, contact your Sysmex service representative. Analysis after error occurrence Ready for analysis (although the next sample could be affected) NOTE: • Press [3] key to return to the Analysis screen. Although the system is ready for analysis, the error may occur in the next analysis.
  • 224. TROUBLESHOOTING 7-20 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message Meaning of Message "HGB Error" *Help* 3:Cancel Clean TD Chamber will be performed. (It will take approx. 7 minutes.) [1] Error occurred during HGB analysis. Flow Cell may be dirty. ERR CODE:XXXXX.X.X 1:Exec. Clean HGB converted value is out of the prescribed range. 1. Blank value is out of the range. 2. Blank value exceeds sample value. Cause 1) Dirty HGB flow cell 2) Bubbles mixed in HGB sample line 3) Dirty WBC TD chamber Action 1) Clean Transducer Press [1] key to execute the transducer rinse sequence. Refer to Chapter 4, Section 5.2: Clean Transducer. Analysis after error occurrence Ready for analysis (although the next sample could be affected) NOTE: • Press [3] key to return to the Analysis screen. Although the system is ready for analysis, the error may occur in the next analysis.
  • 225. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-21 Error Message Meaning of Message "Analysis Error" ERR CODE:XXXXX.X.X *Help* 3:Return WBC/HGB Analysis Error WBC (including HGB) analysis error is continuing. Cause 1) Faulty lyse (STROMATOLYSER-WH) Action 1) Replenish Lyse After replenishing lyse, always execute "4: Replace Reagent" in the Select Menu, making reference to Chapter 4, Section 8.1: Replenish Reagent. After replenishment and checking, analyze the control blood and confirm that there is no abnormality. Analysis after error occurrence Ready for analysis (although the next sample could be affected) NOTE: • Press [3] key to return to the Analysis screen. Although the system is ready for analysis, the error may occur in the next analysis.
  • 226. TROUBLESHOOTING 7-22 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message Meaning of Message "Analysis Error" ERR CODE:XXXXX.X.X *Help* 3:Return Abnormal detection sensitivity Sensitivity in the transducer exceeds the prescribed range. Cause 1) Faulty diluent (CELLPACK) Action 1) Replenish Diluent After replenishing diluent, execute "5: Auto Rinse" in the Select Menu, and perform background check. In addition, analyze the control blood to see that there is no abnormality. Analysis after error occurrence Ready for analysis (although the next sample could be affected) NOTE: • Press [3] key to return to the Analysis screen. Although the system is ready for analysis, the error may occur in the next analysis.
  • 227. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-23 3.7 Memory Errors Error Message Meaning of Message "Memory Error" ERR CODE:XXXXX.X.X *Help* Memory error occurred. Turn OFF then ON the power. Error occurs on the Read Only Memory (ROM) or Random Access Memory (RAM). The alarm keeps sounding. Cause 1) Momentary power failure, sudden noise interference, etc. causes CPU malfunction. Action 1) Turn OFF then ON the power again. Analysis after error occurrence Inoperative (The power could be turned OFF.) Error Message Meaning of Message "Set Value Error" ERR CODE:XXXXX.X.X *Help* Memory error occurred. Stored data,and QC data will be repaired. Repairing may end incomplete. 2 Deleting files and initializing. [1] [2] 1:Repairing 2:Initialize Errors occur in the set values of the following: • Stored data • Quality Control data • Customer-set values Cause 1) Momentary power failure, sudden noise interference, etc. causes analysis value errors. Action 1) Repair Press [1] key to execute repairing. 2) Initializing If execution of "1: Repairing" fails to correct the error, initialize using [2] key. Initializing deletes all stored data and QC data, and set values return to initial values. After completion of initializing, perform all settings referring to Chapter 10: INSTRUMENT SETUP. Analysis after error occurrence Not Ready until the error is resolved.
  • 228. TROUBLESHOOTING 7-24 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message Meaning of Message "Set Value Error" ERR CODE:XXXXX.X.X *Help* Memory error occurred. Turn OFF then ON the power. Errors occur in the set values of the following: • Stored data • Quality Control data • Customer-set values • Factory-set values Cause 1) Momentary power failure or sudden noise interference causes set value errors. Action 1) Turn OFF then ON the power again. If the error persists even after the power is turned OFF then ON, contact your Sysmex service representative for assistance. Analysis after error occurrence Inoperative (The power could be turned OFF.) Error Message Meaning of Message Momentary Power Failure Momentary power failure occurred, or [SHUT DOWN]has not been performed in the last time. Perform[SHUT DOWN]in prior to turning OFF the power. Continue to start up. 1:Continue [1] The program had not been normally quitted the last time the power was turned off. Cause 1) Momentary power failure, etc. caused the unit to stop temporarily. 2) Shutdown had not been performed the last time the unit was turned OFF. Action Press [1] key to start up the unit. Perform SHUTDOWN before turning OFF the power. Analysis after error occurrence Ready for analysis (This error occurs at starting.)
  • 229. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-25 3.8 Others Error Message Meaning of Message "QC Error" ERR CODE:XXXXX.X.X *Help* 3:Return QC data falls out of control limits. This error occurs only when executing Quality Control. Analysis data is out of QC limits. Cause 1) Control blood aspiration error 2) Control blood insufficient mixing 3) Faulty control blood 4) Instrument failure Action 1) Reanalyze Control Blood Press [3] key to return to the QC screen and perform reanalysis. 2) Analyze using New Vial. 3) Maintenance Service of Unit When the above 1) and 2) steps fail to resolve the error, a hardware problem may be suspected. Refer to Chapter 4: INSTRUMENT MAINTENANCE AND SUPPLIES REPLACEMENT and clean the transducer, SRV, etc. Analysis after error occurrence Ready for analysis
  • 230. TROUBLESHOOTING 7-26 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message Meaning of Message "Calibration Error" ERR CODE:XXXXX.X.X *Help* Calibration value is out of range. If error persists, >=5% difference from the last calib. Calib. factor is out of 80%-120%. 3:Return The set calibration value does not meet the conditions: • Difference from the last calibration must not exceed 5%. • Calibration value must be in the range of 80% - 120%. Cause 1) Input error of target or calibration values 2) Instrument failure caused data to shift. Action 1) Checking Entered Values Press [3] key to return to the Calibration screen and check the target or calibration value. • In case of input error of target value in automatic calibration Select "No" on the Update screen for calibration value and execute Auto Calibration again from the beginning. • In case of input error of calibration value in manual calibration Select "No" on the Update screen for calibration value and enter calibration value again. 2) Maintenance of Instrument Check QC data, and if data is found to have shifted, a hardware problem is conceivable. Referring to Chapter 4: INSTRUMENT MAINTENANCE AND SUPPLIES REPLACEMENT, clean the transducer, SRV, etc. Analysis after error occurrence Not Ready until calibration value is fixed.
  • 231. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-27 3.9 Maintenance Errors Error Message Meaning of Message *Scheduled Maint.* 1:Exec.Clean Clean the SRV. Cycle No. after cleaning. 7567 Date last serviced 1/12/1999 Reset the cycle counter for SRV, and you can turn OFF the power. [1] [3] Continue to start up. SRV cycle counter will not be reset. 3:Cancel It is time to clean the SRV. Three months have passed from the previous cleaning. 7500 samples have been analyzed from the previous cleaning. Cause Action Press [1] key. Following the instructions on the screen, turn OFF the power and clean the sample rotor valve (SRV). (Refer to Chapter 4: Section 6.1: Clean Sample Rotor Valve (SRV) ). If you perform cleaning later, press [3] key. This activates the usual startup sequence and makes the system Ready. ∗ The same message will appear the next time you start the unit; it will be displayed at each startup until the cleaning is performed. Analysis after error occurrence Ready for analysis NOTE: • When you clean SRV without pressing [1] key, execute "7: Maintenance," and then "3: Reset Counter" in the Select Menu.
  • 232. TROUBLESHOOTING 7-28 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message Meaning of Message *Scheduled Maint* 1:Exec.Clean Cycle No. after cleaning. 2567 Date last serviced 1/12/1999 3:Cancel Clean the Waste Chamber. It will take approx. 15 minutes. It is time to clean the waste chamber. One month has passed from the previous cleaning. 2500 samples have been analyzed from the previous cleaning. Cause Action Press [1] key. Following the instructions on the screen, clean the waste chamber. (Refer to Chapter 4, Section 5.1: Clean Waste Chamber ). If you perform cleaning later, press [3] key. This activates the usual startup sequence and makes the system Ready. ∗ The same message will appear the next time you start the unit; it will be displayed at each startup until the cleaning is performed. Analysis after error occurrence Ready for analysis NOTE: • When the waste chamber rinse sequence has been completed, the cycle counter is automatically reset.
  • 233. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-29 Error Message Meaning of Message *Scheduled Maint* 1:Exec.Clean Cycle No. after cleaning. 2567 Date last serviced 1/12/1999 3:Cancel Clean the Transducer. It will take approx. 7 minutes. It is time to clean the transducer. One month has passed from the previous cleaning. 2500 samples have been analyzed from the previous cleaning. Cause Action Press [1] key. Following the instructions on the screen, clean the transducer (Refer to Chapter 4, Section 5.2: Clean Transducer). If you perform cleaning later, press [3] key. This activates the usual startup sequence and makes the system Ready. ∗ The same message will appear the next time you start the unit; it will be displayed at each startup until the cleaning is performed. Analysis after error occurrence Ready for analysis NOTE: • When the transducer rinse sequence has been completed, the cycle counter is automatically reset.
  • 234. TROUBLESHOOTING 7-30 Sysmex KX-21N Operator’s Manual -- October 1999 3.10 Printer Errors Error Message Meaning of Message "Abnormal IP " ERR CODE:XXXXX.X.X *Help* Error on IP Press the paper guide lever down. Restarting to print Stop printing on IP [1] [3] To make IP on-line, press[SELECT], then [Periph.Settings] 1:Printing 2:Paper Feed 3:Stop Output The printer has an error. Cause 1) The paper release lever is not in the secured position. Action 1) Confirming the Printer Check the printer, and make it to a normal status. After checking, press [1] key to print the not completed data. 2) Make the Built-in Printer Off-line Press [3] key to make the printer off-line. The main unit becomes Ready but cannot print. When you want to try printing again, refer to Chapter 10: INSTRUMENT SETUP and make settings for connecting the printer. Analysis after error occurrence Not Ready until the error is resolved. For the built-in printer (IP), paper-feed can be performed by pressing [2] key.
  • 235. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-31 Error Message Meaning of Message "Abnormal GP, Abnormal DP " ERR CODE:XXXXX.X.X *Help* ## printout error Check ## Restart printing Stop printing on ## [1] [3] To make ## on-line press[SELECT], then [Periph.Settings] 1:Printing 2:Paper Feed 3:Stop Output The printer has an error. ("GP" (graphic printer) or "DP" (data printer) is displayed in "##" of the screen.) Cause 1) The printer is not connected. 2) There is no power to the printer. 3) Abnormality of connected cable Action 1) Confirming the Printer Check the printer, and make it to a normal status. After checking, press [1] key to print the not completed data 2) Make the Printer Off-line Press [3] key to make the printer off-line. The main unit becomes Ready but cannot print. When you want to try printing again, refer to Chapter 10: INSTRUMENT SETUP and make settings for connecting the printer. Analysis after error occurrence Not Ready until the error is resolved.
  • 236. TROUBLESHOOTING 7-32 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message Meaning of Message "Abnormal IP, Abnormal GP" ERR CODE:XXXXX.X.X *Help* ## paper empty Restarting to print Stop printing on ## [1] [3] To make ## on-line, press[SELECT], then [Periph.Settings] 1:Printing 2:Paper Feed 3:Stop Output Paper found empty . ("IP" (built-in printer) or "GP" (graphic printer) is displayed in "##" of the screen.) Cause 1) No printer paper in the printer Action 1) Replace Print Paper Refer to Chapter 4, Section 8.3: Replace Printer Paper. After replacing, press [1] key to print the data that has not yet printed. 2) Make the Printer Off-line When you press [3], the printer is made off-line. The main unit becomes Ready but cannot print. When you want to try printing, refer to Chapter 10: INSTRUMENT SETUP and make settings for connecting the printer. Analysis after error occurrence Not Ready until the error is resolved. NOTE: • For the built-in printer (IP), paper-feed can be performed by pressing [2] key.
  • 237. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-33 3.11 External Device Errors Error Message Meaning of Message "Host Comm. Error" ERR CODE:XXXXX.X.X *Help* Host Output Error *Host ACK Time Out Error* Check Host Condition Retries to transmit to Host Stop transmitting to Host [1] [3] To make Host Computer on-line, press[SELECT], then [Periph.Settings] 1:Re-sending 3:Stop Output Communications cannot be made with the host computer. There are four cases: • Host Off-line • Host ACK Time Out Error • Host NAK Retry Error • Host Transmission Time Out Error Cause 1) Computer connecting cable failure 2) Computer is not turned ON or not ready for communication. 3) Host computer serial interface error Action 1) Inspect Host Computer Cable 2) Inspect Connection Cable When you press [1] key after inspection, data transmission is resumed. 3) Disconnecting Host Computer When you press [3] key, transmission to the host computer is canceled and the host is off-lined in the main unit. The main unit is now Ready but cannot output to the host computer. To resume transmission to the host computer, refer to Chapter 10: INSTRUMENT SETUP and make settings for connecting the host computer. Analysis after error occurrence Not Ready until the error is resolved.
  • 238. TROUBLESHOOTING 7-34 Sysmex KX-21N Operator’s Manual -- October 1999 4 . STATUS DISPLAY The unit has the Status Display screen by which you can confirm the status of the instrument. The Status Display screen displays in real time a currently-running sequence, pressure/vacuum readings, sensor status, and solenoid valve operating status. You can also confirm on the screen HGB Converted value, cycle Nos. after performing the last maintenance, and currently-registered cycle No. (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance." (3) Press [ENTER] key. The Maintenance Menu screen appears. *Maintenance* 1:Clean W.Chamber 2:Clean Transducer 3:Reset SRV Counter 4:Drain TD Chamber 5:Status Display 6:Print Error History 7:Program Version Figure 7-4-1: Maintenance Menu Screen (4) Using [ ] key or [ ] key, move the cursor to select "5: Status Display." (5) Press [ENTER] key. The Status Display screen appears. NOTE: • On the Menu screen, each menu can be selected directly by entering a numeral from the numeric keys. The Status Display screen comprises two pages; you can turn over the pages using [ ] key or [ ] key. Page Selection in Status Dislay Screen P1. Status Display Screen 1 P2. Status Display Screen 2 Figure 7-4-2: Page Selection in Status Display Screen
  • 239. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-35 SEQ.No. 12 1 2 3 4 SV 1 2 3 4 5 6 7 8 9 0 SENSOR 1 2 3 4 5 6 7 HGB CONVERT 550 VACUUM 0.0320 1 2 3 4 5 6 7 8 9 0 PRESSURE 0.051 WB 0.0333 MPa Vacuum HGB Converted Value Sensor status Solenoid valve operating status Change screen with [ ] or [ ] Ready *Status* Sequence No. 0.05 MPa Pressure Figure 7-4-3: P1. Status Display Screen 1 *Status* COUNTER 1234567 SRV 7567 DETECTOR 2567 WASTE CHAMBER 2567 WB Cycle No. after cleaning waste chamber Cycle No. Cycle No. after cleaning transducer Cycle No. after cleaning SRV Change screen with [ ] or [ ] Ready Figure 7-4-4: P2. Status Display Screen 2 Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 240. TROUBLESHOOTING 7-36 Sysmex KX-21N Operator’s Manual -- October 1999 5 . ERROR HISTORY PRINT Recent occurred ten times error history can be printed from the built-in printer. Execution of Error History Print (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance." (3) Press [ENTER] key. The Maintenance Menu screen appears. *Maintenance* 1:Clean W.Chamber 2:Clean Transducer 3:Reset SRV Counter 4:Drain TD Chamber 5:Status Display 6:Print Error History 7:Program Version Figure 7-5-1: Maintenance Menu Screen (4) Using [ ] key or [ ] key, move the cursor to select "6: Print Error History." (5) Press [ENTER] key. The built-in printer prints the error history. Print Example .... Date 31/12/2000 Time 23:59 *Error History* Date 31/12/2000 Time 13:00 Pressure/Vac Error XXXXXX.XXXXXX.XXXXXX Date 24/12/2000 Time 09:15 Waste Not Draining XXXXXX.XXXXXX.XXXXXX Date 24/12/2099 Time 12:30 Host Comm. Error XXXXXX.XXXXXX.XXXXXX Figure 7-5-2: Error History Print
  • 241. TROUBLESHOOTING Sysmex KX-21N Operator’s Manual -- October 1999 7-37 6 . PROGRAM VERSION This menu can be used to display the program version. (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance." (3) Press [ENTER] key. The Maintenance Menu screen appears. *Maintenance* 1:Clean W.Chamber 2:Clean Transducer 3:Reset SRV Counter 4:Drain TD Chamber 5:Status Display 6:Print Error History 7:Program Version Figure 7-6-1: Maintenance Menu Screen (4) Using [ ] key or [ ] key, move the cursor to select "7: Program Version." (5) Press [ENTER] key. The Program Version screen appears. Program Version [1KXNF ##-##] *Program Version* Figure 7-6-2: Program Version Screen
  • 242. Sysmex KX-21N Operator’s Manual -- Revised February 2000 CHAPTER 8 ADJUSTMENT 1. INTRODUCTION................................................................. 8-1 2. ADJUSTMENT OF PRESSURE AND VACUUM........................... 8-2 2.1 Location of Control Knobs................................................ 8-2 2.2 Pressure and Vacuum Display ............................................ 8-3 2.3 Adjusting Pressure to 0.05 MPa.......................................... 8-5 2.4 Adjusting Vacuum to 0.0333 MPa ....................................... 8-6
  • 243. ADJUSTMENT Sysmex KX-21N Operator’s Manual -- Revised February 2000 8-1 1 . INTRODUCTION The adjustment procedures described here are important in maintaining accuracy of this instrument. Your Sysmex service representative will perform initial adjustment. Should it require any adjustment subsequently, follow the procedures given below. The following adjustment procedures are explained in this chapter. • Pressure: 0.05 MPa • Vacuum: 0.0333 MPa
  • 244. ADJUSTMENT 8-2 Sysmex KX-21N Operator’s Manual -- Revised February 2000 2 . ADJUSTMENT OF PRESSURE AND VACUUM Pressure and vacuum from the built-in Pneumatic Unit are regulated to 0.05 MPa and 0.0333 MPa. The pressure and vacuum are always monitored by pressure sensors. When an error occurs, an error message is displayed. If the pressure or vacuum error message is displayed, check tubing connections or the like for any air leakage. If there is no such error, display the Status Display screen and adjust pressure or vacuum as required. 2.1 Location of Control Knobs 0.05 MPa Regulator 0.0333 MPa Bellows Unit Figure 8-2-1: Location of Control Knobs NOTE: • When an error has occurred, press [HELP] key to check pressure or vacuum value on the Help screen. (Refer to Chapter 7: TROUBLESHOOTING.) *Help* 0.05 MPa Pressure Error 0.034 [0.039 - 0.059] ERR CODE: XXXX.X.X Adjust 0.05 MPa Pressure 1 Restarting to monitor the pressure 1:End of Adj Figure 8-2-2: Help Screen
  • 245. ADJUSTMENT Sysmex KX-21N Operator’s Manual -- Revised February 2000 8-3 2.2 Pressure and Vacuum Display (1) Press [SELECT] key when the status is "Ready." The Select Menu screen appears. (2) Move the cursor using [ ] key or [ ] key, and select "7: Maintenance." (3) Press [ENTER] key. The Maintenance Menu screen appears. *Maintenance* 1:Clean W.Chamber 2:Clean Transducer 3:Reset SRV Counter 4:Drain TD Chamber 5:Status Display 6:Print Error History 7:Program Version Figure 8-2-3: Maintenance Menu Screen (4) Move the cursor using [ ] key or [ ] key, and select "5: Status Display." (5) Press [ENTER] key. The Status Display screen appears. SEQ.No. 12 1 2 3 4 SV 1 2 3 4 5 6 7 8 9 0 SENSOR 1 2 3 4 5 6 7 HGB CONVERT 550 VACUUM 0.0320 1 2 3 4 5 6 7 8 9 0 PRESSURE 0.051 WB Ready *Status* Change screen with [ ] or [ ] Figure 8-2-4: Status Display Screen NOTE: • Each menu can be selected directly on the Menu screen by entering a numeral from the numeric keys.
  • 246. ADJUSTMENT 8-4 Sysmex KX-21N Operator’s Manual -- Revised February 2000 NOTE: • The Status Display screen shows current pressure and vacuum. SEQ.No. 12 1 2 3 4 SV 1 2 3 4 5 6 7 8 9 0 SENSOR 1 2 3 4 5 6 7 HGB CONVERT 550 VACUUM 0.0320 1 2 3 4 5 6 7 8 9 0 PRESSURE 0.051 WB Ready *Status* Vacuum: 0.0333 MPa (displaying 0.0320 MPa) Pressure: 0.05 MPa (displaying 0.051 MPa) Change screen with [ ] or [ ] Figure 8-2-5: Status Display Screen (6) Adjust the pressure and vacuum by following the procedures given on the next page and later.
  • 247. ADJUSTMENT Sysmex KX-21N Operator’s Manual -- Revised February 2000 8-5 2.3 Adjusting Pressure to 0.05 MPa (1) Using the procedure of "2.2 Pressure and vacuum Display," display the Status Display screen. (2) Loosen the 0.05 MPa regulator locking nut on the left side of the unit. (3) While watching the pressure and vacuum indication on the Status Display screen, turn the adjusting knob to regulate pressure and vacuum. Turn the adjusting knob clockwise to increase pressure and vacuum. Adjustment range: 0.05±0.01 MPa Low High Locking nut Adjusting knob Loosen Figure 8-2-6: Adjusting the Pressure CAUTION: • Always adjust pressure and vacuum so as to increase to the predetermined levels. Should any of them be too high, lower it to below that level once, then raise it to the set level. Unless adjustment is properly conducted, accurate adjustment may not be possible. (4) When adjustment is finished, tighten the locking nut while taking care not to allow the adjusting knob to rotate. (5) Press [SELECT] key to return to the Ready status.
  • 248. ADJUSTMENT 8-6 Sysmex KX-21N Operator’s Manual -- Revised February 2000 2.4 Adjusting Vacuum to 0.0333 MPa (1) Using the procedure of "2.2 Pressure and Vacuum Display," display the Status Display screen. (2) By turning counterclockwise, loosen the locking nut for the bellows unit on the left side of the unit. (3) While watching the pressure and vacuum indication on the Status Display screen, turn the adjusting knob to regulate pressure and vacuum. Turn the adjusting knob clockwise to increase pressure and vacuum. Adjustment range: 0.0333±0.0013 MPa HighLow Locking nut Adjusting knob Loosen Figure 8-2-7: Adjusting the Vacuum CAUTION: • Always adjust pressure and vacuum so as to increase to the predetermined levels. Should any of them be too high, lower it to below that level once, then raise it to the set level. Unless adjustment is properly conducted, accurate adjustment may not be possible. (4) When adjustment is finished, tighten the locking nut while taking care not to allow the adjusting knob to rotate. (5) Press [SELECT] key to return to the Ready status.
  • 249. Sysmex KX-21N Operator’s Manual -- October 1999 CHAPTER 9 FUNCTIONAL DESCRIPTION 1. INTRODUCTION ................................................................. 9-1 2. DETECTION PRINCIPLE ....................................................... 9-2 2.1 DC Detection Method....................................................... 9-2 2.2 Non-Cyanide Hemoglobin Analysis Method ............................ 9-2 3. MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM ...... 9-4 4. CBC ANALYSIS .................................................................. 9-5 4.1 WBC/HGB Analysis Flow ................................................ 9-5 4.2 RBC/PLT Analysis Flow .................................................. 9-7 4.3 Calculation of RBC Constant.............................................. 9-9 5. BLOOD CELL DISCRIMINATION CIRCUIT.............................. 9-10 5.1 WBC Discriminator....................................................... 9-10 5.2 RBC Discriminator........................................................ 9-10 5.3 PLT Discriminator ........................................................ 9-10 6. ANALYSIS OF HISTOGRAM ................................................ 9-11 6.1 Analysis of WBC Histogram ............................................ 9-11 6.2 Analysis of RBC/PLT Histogram....................................... 9-20 7. ELECTRIC SYSTEM ........................................................... 9-28 8. NAMES AND FUNCTIONS OF INSTRUMENTS ........................ 9-30 8.1 Front Panel................................................................. 9-30 8.2 Front Interior .............................................................. 9-31 8.3 Right Side Panel........................................................... 9-32 8.4 Left Side Panel ............................................................ 9-33 8.5 Left Side Interior .......................................................... 9-34 8.6 Rear Panel.................................................................. 9-35
  • 250. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-1 1 . INTRODUCTION This chapter describes blood cell count detection principle and analysis method used in this instrument, and flow of individual analysis. Also the hardware elements are explained. • Detection Principle: Principle each of DC detection method and non-cyanide hemoglobin analysis method is described. • Flow of Analysis: Flow of each analysis parameter on the main unit and analysis method for particle distribution are described. • Function of Measuring Unit: Names and functions of the measuring unit's elements are briefly described.
  • 251. FUNCTIONAL DESCRIPTION 9-2 Sysmex KX-21N Operator’s Manual -- October 1999 2 . DETECTION PRINCIPLE This instrument performs blood cell count by DC detection method. 2.1 DC Detection Method Blood sample is aspirated, measured to a predetermined volume, diluted at the specified ratio, then fed into each transducer. The transducer chamber has a minute hole called the aperture. On both side of the aperture, there are the electrodes between which flows direct current. Blood cells suspended in the diluted sample pass through the aperture, causing direct current resistance to change between the electrodes. As direct current resistance changes, the blood cell size is detected as electric pulses. Blood cell count is calculated by counting the pulses, and a histogram of blood cell sizes is plotted by determining the pulse sizes. Also, analyzing a histogram makes it possible to obtain various analysis data. Internal Electrode - External Electrode + Blood Cell Suspension Aperture DC Supply Resistance DC Transducer Chamber Figure 9-2-1: DC Detection Method 2.2 Non-Cyanide Hemoglobin Analysis Method To analyze hemoglobin by automated methods, the Cyanmethemoglobin method or Oxyhemoglobin method have so far been the main stream. Cyanmethemoglobin method was recommended as the international standard method in 1966 by ICSH (International Committee for Standardization in Hematology). This method, however, is so low in hemoglobin conversion rate that it cannot be said an appropriate method in the automated process in which multi-sample processing is the pre-condition. In addition, this method uses the reagent of cyanide compound which is a poisonous substance and requires waste processing; thus, it can hardly be called an environmentally favorable method. At present, this method cannot be said suitable for a fully-automated instrument which is required to handle a large amount of waste.
  • 252. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-3 The Oxyhemoglobin method, on the other hand, is faster in hemoglobin conversion rate; in fact, blood hemoglobin is converted instantaneously into oxyhemoglobin. Also, it does not contain poisonous substance as cyanmethemoglobin method, making the method suitable for automation. This method, however, is unable to convert methemoglobin into oxyhemoglobin. Consequently, when a great amount of methemoglobin is contained as in control blood, lower-than-real values result, although usual human blood poses no problems. Non-cyanide hemoglobin analysis method utilizes the advantages of both of the above methods. Non-cyanide hemoglobin analysis method rapidly converts blood hemoglobin as the Oxyhemoglobin method and contains no poisonous substance, making it suitable for automated method. Being capable of analyzing methemoglobin, this method can accurately analyze control blood, etc. which contain methemoglobin.
  • 253. FUNCTIONAL DESCRIPTION 9-4 Sysmex KX-21N Operator’s Manual -- October 1999 3 . MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM <Whole Blood Mode> SampleRotorValve (SRV) Diluent WBC/HGB Lyse 1.996 mL 1.960 mL 1.994 mL 1.0 mL 4.0 µL (1:500) 6 µL 40 µL (1:25000) (1:500) (1:500) Whole Blood Sample (50 µL) Mixing Chamber RBC TD Chamber WBC TD Chamber HGB Flow Cell Figure 9-3-1: Hydraulic System in Whole Blood Mode <Pre-diluted Mode> 1.99792 mL 2.08 µL 1.922 mL 78 µL 1.0 mL SampleRotorValve (SRV) Diluent WBC/HGB Lyse (1:1000) (1:1000) (1:25000) 1:26 Diluted Sample (200 µL) Mixing Chamber RBC TD Chamber WBC TD Chamber HGB Flow Cell Figure 9-3-2: Hydraulic System in Pre-diluted Mode
  • 254. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-5 4 . CBC ANALYSIS 4.1 WBC/HGB Analysis Flow In WBC and HGB analysis, the volume of WBC and hemoglobin in the blood are measured. The flow of WBC/HGB analysis is described below: WBC Transducer Sample Rotor Valve Whole Blood Mode : Diluent 1.994 mL Whole Blood 6 µL Pre-diluted Mode : Diluent 1.922 mL 1:26 Diluted Sample 78 µL Whole Blood Mode 1 mL Pre-diluted Mode 1 mL WBC/HGB Lyse: Whole Blood Mode 1.0 mL Pre-diluted Mode 1.0 mL HGB Flow Cell Tube or Microtube Whole Blood Mode: 50 µL Pre-diluted Mode: 1:26 Diluted Sample 200 µL Diluent: 2.0 mL Figure 9-4-1: WBC/HGB Analysis Flow • Whole Blood Mode (1) Blood is aspirated from the sample probe into the sample rotor valve. (2) 6 µL of blood measured by the sample rotor valve is transferred to the WBC transducer chamber along with 1.994 mL of diluent. At the same time, 1.0 mL of WBC/HGB lyse is added to prepare 1:500 dilution sample. When the solution is made to react in this status for approximately 10 seconds, RBC is hemolyzed and platelets shrink, with WBC membrane held as they are. At the same time, hemoglobin is converted into red colored methemoglobin. (3) Of the diluted/hemolyzed sample in the WBC transducer chamber, approximately 1 mL is transferred to the HGB flow cell.
  • 255. FUNCTIONAL DESCRIPTION 9-6 Sysmex KX-21N Operator’s Manual -- October 1999 (4) 500 µL of sample in the WBC transducer is aspirated through the aperture. The pulses of the blood cells when passing through the aperture are counted by the DC detection method. (5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting diode (LED) is applied to the sample in the HGB flow cell. Concentration of this sample is measured as absorbance. This absorbance is compared with that of the diluent alone that was measured before addition of the sample, thereby calculating HGB (hemoglobin value). • Pre-diluted Mode (1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. This sample is aspirated from the sample probe into the sample rotor valve. (2) 78 µL of diluted blood measured by the sample rotor valve is transferred to the WBC transducer chamber along with 1.922 mL of diluent. At this time, 1.0 mL of WBC/HGB lyse is added to prepare 1:1000 dilution sample. When the solution is made to react in this status for approximately 10 seconds, RBC is hemolyzed and platelets shrink, with WBC membrane held as they are. At the same time, hemoglobin is converted into red colored methemoglobin. (3) Of the diluted/hemolyzed sample in the WBC transducer chamber, approximately 1 mL is transferred to the HGB flow cell. (4) 500 µL of sample in the WBC transducer chamber is aspirated through the aperture. The pulses of the blood cells when passing through the aperture are counted by the DC detection method. (5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting diode (LED) is applied to the sample in the HGB flow cell. Concentration of this sample is measured as absorbance. This absorbance is compared with that of the diluent alone that was measured before addition of the sample, thereby calculating HGB (hemoglobin value).
  • 256. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-7 4.2 RBC/PLT Analysis Flow In RBC/PLT analysis, RBC and platelet count in the blood are measured. The flow of RBC/PLT analysis is described below: • Whole Blood Mode Mixing Chamber (1:500 Diluted Sample: 40 µL) Tube (Whole Blood: 50 µL) Sample Rotor Valve Diluent: 2.0 mL Diluent 1.996 mL Whole Blood 4 µL Diluent 1.960 mL 1:500 Diluted Sample 40 µL RBC/PLT Transducer Figure 9-4-2: RBC/PLT Analysis Flow in Whole Blood Mode (1) Blood is aspirated from the sample probe into the sample rotor valve. (2) 4.0 µL of blood measured by the sample rotor valve is diluted into 1:500 with 1.996 mL of diluent and brought to the mixing chamber as diluted sample. (1st step dilution) (3) Out of the 1:500 dilution sample, 40 µL is measured by the sample rotor valve, diluted into 1:25000 with 1.960 mL of diluent, then transferred to the RBC/PLT transducer chamber. (2nd step dilution) (4) 250 µL of the sample in the RBC/PLT transducer chamber is aspirated through the aperture. At this time, RBC and PLT are counted by the DC detection method. At the same time, HCT (hematocrit value) is calculated by RBC pulse height detection method.
  • 257. FUNCTIONAL DESCRIPTION 9-8 Sysmex KX-21N Operator’s Manual -- October 1999 • Pre-diluted Mode Microtube (1:26 Diluted Sample: 200 µL) RBC/PLT Transducer Diluent 1.99792 mL 1:26 Diluted Sample 2.08 µL Sample Rotor Valve Diluent : 2.0 mL Figure 9-4-3: RBC/PLT Analysis Flow in Pre-diluted Mode (1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. This sample is aspirated from the sample probe into the sample rotor valve. (2) 2.08 µL of diluted blood measured by the sample rotor valve is transferred in 1.99792 mL of diluent to the RBC/PLT transducer chamber, and is made into 1:25000 dilution sample. (3) Of the sample in the RBC/PLT transducer chamber, 250 µL is aspirated through the aperture. At this time, RBC and PLT are calculated by the DC detection method. At the same time, HCT (hematocrit value) is calculated by RBC pulse height detection method.
  • 258. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-9 4.3 Calculation of RBC Constant RBC constant (mean RBC volume, mean RBC hemoglobin, mean RBC hemoglobin concentration) is calculated from RBC, HGB, and HCT. 1. Mean RBC Volume (MCV) Calculation is made from RBC and HCT by the formula below: MCV (fL) = HCT (%) RBC (×10 6 /µL) ×10 2. Mean RBC Hemoglobin (MCH) Calculation is made from RBC and HGB by the formula below: MCH (pg) = HGB (g/dL) RBC (×10 6 /µL) ×10 3. Mean RBC Hemoglobin Concentration (MCHC) Calculation is made from HCT and HGB by the formula below: MCHC (g/dL) = HGB (g/dL) HCT (%) ×100
  • 259. FUNCTIONAL DESCRIPTION 9-10 Sysmex KX-21N Operator’s Manual -- October 1999 5 . BLOOD CELL DISCRIMINATION CIRCUIT WBC, RBC, and PLT are discriminated and calculated by the following blood cell discriminator. 5.1 WBC Discriminator As to WBC LOWER discriminator, the optimum position in 30 - 60 fL is automatically determined by the microcomputer. WBC is calculated from the particle counts more than this LOWER discriminator. 5.2 RBC Discriminator As to RBC LOWER discriminator and UPPER discriminator, the optimum position in 25 - 75 fL and 200 - 250 fL, respectively, are automatically determined by the microcomputer. RBC is calculated from the particle counts between this LOWER discriminator and UPPER discriminator. 5.3 PLT Discriminator As to PLT LOWER discriminator and UPPER discriminator, the optimum position in 2 - 6 fL and 12 - 30 fL, respectively, are automatically determined by the microcomputer. PLT count is calculated from the particle counts between this LOWER discriminator and UPPER discriminator.
  • 260. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-11 6 . ANALYSIS OF HISTOGRAM Analysis of histogram allows use of the flagging system that suggests sample error or instrument error. Histograms of WBC, RBC, and PLT can be calculated respectively within the ranges given below. WBC: Approx. 30 - 300 fL (particle after lyse dripping) RBC: Approx. 25 - 250 fL PLT: Approx. 2 - 30 fL 6.1 Analysis of WBC Histogram 1 . WBC Histogram The WBC histogram is discriminated into small, middle, and large WBC by 3-part differential method using 4 discriminators. The LOWER discriminator (LD) is automatically determined at an optimum position between 30 and 60 fL. The UPPER discriminator (UD) is fixed at 300 fL, which is used as the monitor for histogram error. The WBC histogram troughs in the (LD)-to-(UD) range are determined; the 1st one is defined TROUGH Discriminator 1 (T1) and the 2nd one TROUGH Discriminator 2 (T2). • WBC Histogram 300 WBC UD Lymphocytes Mixed cells Neutrophils 200100 LD T1 T2 [fL] Figure 9-6-1: WBC Histogram 1 ) LYM# [W-SCC (WBC-Small Cell Count) ] Lymphocytes between discriminator (LD) and (T1), which is considered highly correlated with lymphocyte count. 2 ) MXD# [W-MCC (WBC-Middle Cell Count) ] Mixed cells between discriminator (T1) and (T2), which is considered highly correlated with the sum of monocytes, basophils, and eosinophils. 3 ) NEUT# [W-LCC (WBC-Large Cell Count)] Neutrophils more than discriminator (T2), which is considered highly correlated with neutrophils.
  • 261. FUNCTIONAL DESCRIPTION 9-12 Sysmex KX-21N Operator’s Manual -- October 1999 4 ) LYM% [W-SCR (WBC-Small Cell Ratio) ] Ratio of lymphocytes to whole WBC 5 ) MXD% [W-MCR (WBC-Middle Cell Ratio) ] Ratio of mixed cells to whole WBC 6 ) NEUT% [W-LCR (WBC-Large Cell Ratio) ] Ratio of neutrophils to whole WBC
  • 262. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-13 2 . WBC Histogram Error Flag When the WBC histogram is normal with three peaks, there are a lower trough (T1) and a higher trough (T2) between LOWER discriminator (LD) and UPPER discriminator (UD). • Output Example of Normal WBC Three-Peak Histogram 300 WBC UD 200100 LD T1 T2 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# 6.7 28.3 17.4 54.3 1.9 1.2 3.6 [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] Figure 9-6-2: Normal WBC Three-Peak Histogram When TROUGH Discriminator (T1) or (T2) cannot be set or when frequency for a set discriminator position is higher than the range, it is flagged as WBC histogram error. Those histogram error flags are listed below in the order of higher priority. If more than one flag are applied, the flag of the highest priority is taken. WL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable cause is inclusion of numerous platelet agglutinations, large platelets, and etc. T1: Lower TROUGH Discriminator, that distinguishes lymphocytes and mixed cells, cannot be not determined. T2: Higher TROUGH Discriminator, that distinguishes mixed cells and neutrophils, cannot be not determined. F1: Small cell histogram error. Relative frequency for T1 exceeds the range. F2: Middle cell histogram error. Relative frequency for T1 or T2 exceeds the range. F3: Large cell histogram error. Relative frequency for T2 exceeds the range. WU: Relative frequency for UPPER discriminator (UD) exceeds the range. Applicable cases are those in which hemolysis is insufficient (for instance, samples whose RBC membrane has extremely strong resistance against lyse) or in which numerous abnormal blood cells are present. AG: The particle count equal to or less than the LD exceeds a prescribed range. Probable cause is platelet agglutination, which does not alter WBC count but may result in decreased platelet count. Therefore, this flag is added to the PLT parameter.
  • 263. FUNCTIONAL DESCRIPTION 9-14 Sysmex KX-21N Operator’s Manual -- October 1999 • WBC and Calculation Parameters versus Analysis Value Error Flags O WBC Histogram Error Flag Output [1] [2] [1] : Output flag to LCD screen, printer. [2] : Output flag to host computer. O : Analysis result of each discriminator is normal High : Frequency for each discriminator is higher than the range. × : A trough is not clear and cannot be detected. : Any of "O ," "×," and "High" is applicable. Case No. LD T1 T2 UD WBC LYM% MXD% NEUT% LYM# MXD# NEUT# HOST 1 2A 2B 3A 3B 3C 3D 4A 4B 4C 4D 5A 5B 6 High O O O O O O O O O O O O O O O O O O O OO O O O O OO O × × High High High High High High × × × × High High High High High High High High High High High WL WU WU WU WU WU WU WU WL T1 T1 F1 F1 F1 F1 F1 F1 WL T1 T1 T2 T2 T2 T2 F2 F2 F2 F2 F2 F2 WL T1 T1 T2 T2 T2 T2 F3 F3 F3 F3 WL T1 T1 F1 F1 F1 F1 F1 F1 WL T1 T1 T2 T2 T2 T2 F2 F2 F2 F2 F2 F2 WL T1 T1 T2 T2 T2 T2 F3 F3 F3 F3 1 5 5 6 6 6 6 7 7 7 7 8 8 2 7 (The particle count equal to or less than LD is higher than the range) PLT parameter is flagged with AG. 2 Table 9-6-1: WBC Histogram Error Flags NOTE: • When analyzing in the pre-diluted mode, since CBC8 parameters only are output, flagging is limited to a WBC parameter.
  • 264. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-15 1 ) 1A Histogram having high LD frequency with troughs T1 and T2 WL flag is added to all WBC parameters (WBC, LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#). • WBC Histogram Error-WL (1A) WBC UDLD T1 T2 8.5 39.3 17.6 43.1 3.4 1.5 3.6 [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] 300200100 [fL] WL WL WL WL WL WL WL WBC LYM% MXD% NEUT% LYM# MXD# NEUT# Figure 9-6-3: WBC Histogram Error-WL (1A) 2 ) 1B Histogram with high LD and trough T1 but without T2 WL flag is added to all analysis results for WBC, LYM% and LYM#. WL flag is added to mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#, NEUT#) and their data are not output. ([---.-]) • WBC Histogram Error-WL (1B) WL WL WL WL WL WL WL WBC UDLD T1 2.8 45.9 ---.- ---.- 1.3 ---.- ---.- [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] 300200100 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# Figure 9-6-4: WBC Histogram Error-WL (1B) 3 ) 1C Histogram with high LD but without T1 WL flag is added to WBC and other parameters are not output. Note [+] on WBC numeric data in the example below. This WBC value exceeds the upper Patient Mark Limits mentioned earlier. • WBC Histogram Error-WL (1C) WL WL WL WL WL WL WL WBC UD +16.4 ---.- ---.- ---.- ---.- ---.- ---.- LD . [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] 300200100 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# Figure 9-6-5: WBC Histogram Error-WL (1C)
  • 265. FUNCTIONAL DESCRIPTION 9-16 Sysmex KX-21N Operator’s Manual -- October 1999 4 ) 2A Histogram without T1 Although the histogram error flag is not added to WBC, all other parameters are flagged with T1 and their data are not output. Note that WBC in the graph exceeds the upper Patient Mark Limits. • WBC Histogram Error-T1 (2A) WBC UDLD +15.4 ---.- ---.- ---.- ---.- ---.- ---.- [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] 300200100 [fL] T1 T1 T1 T1 T1 T1 WBC LYM% MXD% NEUT% LYM# MXD# NEUT# Figure 9-6-6: WBC Histogram Error-T1 (2A) 5 ) 2B Histogram having high UD but without T1 WBC is flagged with WU. All other parameters are flagged with T1 and their data are not output. 6 ) 3A Histogram with high T1 but without T2 WBC is not flagged. F1 flag is added to lymphocyte parameters (LYM%, LYM#). Mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#, NEUT#) are flagged with T2 and their data are not output. • WBC Histogram Error-T2 (3A) WBC UDLD T1 5.2 29.7 ---.- ---.- 1.5 ---.- ---.- [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] 300200100 [fL] F1 T2 T2 F1 T2 T2 WBC LYM% MXD% NEUT% LYM# MXD# NEUT# Figure 9-6-7: WBC Histogram Error-T2 (3A) 7 ) 3B Histogram with high T1 but without T2, and high in UD frequency WBC is flagged with WU and lymphocyte parameters (LYM%, LYM#) are flagged with F1. Mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#, NEUT#) are flagged with T2 and their data are not output.
  • 266. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-17 8 ) 3C Histogram with T1 but without T2 WBC and lymphocyte parameters (LYM%, LYM#) are not flagged as the histogram error. Mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#, NEUT#) are flagged with T2 and data are not output. WBC shown below exceeds the upper Patient Mark Limits. • WBC Histogram Error-T2 (3C) 300 WBC UDLD T1 [fL] +15.2 12.9 ---.- ---.- 1.6 ---.- ---.- [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] 200100 T2 T2 T2 T2 WBC LYM% MXD% NEUT% LYM# MXD# NEUT# Figure 9-6-8: WBC Histogram Error-T2 (3C) 9 ) 3D Histogram with high T1 but no T2, and with high UD WBC is flagged with WU. Lymphocyte parameters (LYM%, LYM#) are not flagged. Mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#, NEUT#) are flagged with T2 and their data are not output. 10) 4A Histogram with high T1 WBC and neutrophil parameters (NEUT%, NEUT#) are not flagged. Lymphocyte parameters (LYM%, LYM#) are flagged with F1 and mixed cell parameters (MXD%, MXD#) are flagged with F2. • WBC Histogram Error - F1 (4A) WBC LD T1 T2 6.7 28.3 17.4 54.3 1.9 1.2 3.6 UD [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] 300200100 [fL] F1 F2 F1 F2 WBC LYM% MXD% NEUT% LYM# MXD# NEUT# Figure 9-6-9: WBC Histogram Error - F1 (4A) 11) 4B Histogram with high T1 and UD WBC is flagged with WU, lymphocyte parameters (LYM%, LYM#) are flagged with F1, and mixed cell parameters (MXD%, MXD#) with F2. Neutrophil parameters (NEUT%, NEUT#) are not flagged.
  • 267. FUNCTIONAL DESCRIPTION 9-18 Sysmex KX-21N Operator’s Manual -- October 1999 12) 4C Histogram with high T1 and high T2 WBC is not flagged. Lymphocyte parameters (LYM%, LYM#) are flagged with F1, mixed cell parameters (MXD%, MXD#) with F2, and neutrophil parameters (NEUT%, NEUT#) with F3. • WBC Histogram Error - F1 (4C) WBC UDLD T1 T2 10.7 20.8 11.2 68.0 2.2 1.2 7.3 [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] 300200100 [fL] F1 F2 F3 F1 F2 F3 WBC LYM% MXD% NEUT% LYM# MXD# NEUT# Figure 9-6-10: WBC Histogram Error - F1 (4C) 13) 4D Histogram high in all T1, T2, and UD WBC data are output with WU flag, lymphocyte parameters (LYM%, LYM#) with F1 flag, mixed cell parameters (MXD%, MXD#) with F2 flag, and neutrophil parameters (NEUT%, NEUT#) with F3 flag. 14) 5A Histogram with high T2 Histogram error flag is not added to WBC and lymphocyte parameters (LYM%, LYM#). Mixed cell parameters (MXD%, MXD#) are flagged with F2, and neutrophil parameters (NEUT%, NEUT#) with F3 flag. WBC and MXD% exceed the upper Patient Mark Limits. • WBC Histogram Error - F2 (5A) WBC UDLD T1 T2 +18.5 9.5 +23.7 66.8 1.1 2.7 7.7 [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] 300200100 [fL] F2 F3 F2 F3 WBC LYM% MXD% NEUT% LYM# MXD# NEUT# Figure 9-6-11: WBC Histogram Error - F2 (5A) 15) 5B Histogram with high T2 and high UD WBC is flagged with WU and lymphocyte parameters (LYM%, LYM#) are not flagged. Mixed cell parameters (MXD%, MXD#) are flagged with F2, and neutrophil parameters (NEUT%, NEUT#) with F3.
  • 268. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-19 16) 6 Histogram with high UD WBC is flagged with WU and other parameters are not flagged. WBC in this instance exceeds the upper Patient Mark Limits. • WBC Histogram Error - WU (6) WBC UDLD T1 T2 + 15.4 24.5 7.5 68 3.3 1.0 8.1 [×103 /µL] [%] [%] [%] [×103 /µL] [×103 /µL] [×103 /µL] 300200100 [fL] WUWBC LYM% MXD% NEUT% LYM# MXD# NEUT# Figure 9-6-12: WBC Histogram Error - WU (6) 17) 7 The particle count equal to or less than LD is higher than the range. PLT is flagged with AG and other parameters are not flagged.
  • 269. FUNCTIONAL DESCRIPTION 9-20 Sysmex KX-21N Operator’s Manual -- October 1999 6.2 Analysis of RBC/PLT Histogram 1 . RBC Histogram As mentioned earlier, RBC are determined as particle counts between two discriminators (LD) and (UD) which are automatically counted in the ranges of 25 - 75 fL and 200 - 250 fL, respectively. As to histogram, check is made for relative frequency errors on respective discriminator levels, for more than one peak, and for distribution width error. In addition, this instrument is capable of expressing RBC distribution width (RDW) by two methods below: RDW-CV (RBC Distribution Width - Coefficient of Variation) is calculated by the formula below, after determining points L1 and L2 for 68.26% of the entire particle area. The unit applied is %. • Calculation of RDW-CV RDW-CV (%) = L2 - L1 L2 + L1 ×100 L2L1 68.26% of Entire Distribution Area Figure 9-6-13: Calculation of RDW-CV RDW-SD (RBC Distribution Width - Standard Deviation) is set on 20% frequency level with the peak taken as 100%. The unit applied is fL (femto-liter = 10-15 L). • Definition of RDW-SD 100% 20% RDW-SD Figure 9-6-14: Definition of RDW-SD Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 270. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 9-21 2 . PLT Histogram Platelet histogram is analyzed using three discriminators: two discriminators (LD) and (UD) - determined automatically between 2 - 6 fL and between 12 - 30 fL, respectively -and the fixed discriminator at 12 fL. Regarding PLT histogram, check is made to see that there are no relative frequency errors at discriminators (LD) and (UD), distribution width error, and there is a single peak. 1 ) MPV (Mean Platelet Volume) MPV is calculated by the following formula: MPV (fL) = PCT (%) PLT (×10 3 /µL) ×1000 Where PCT (%) represents the value weighted with PLT frequency and is called platelet-crit or platelet volume ratio. The analysis method used is the same as mentioned in HCT analysis principle 4.2 RBC/PLT Analysis Flow in this chapter.
  • 271. FUNCTIONAL DESCRIPTION 9-22 Sysmex KX-21N Operator’s Manual -- October 1999 3 . RBC Histogram Error Flag When RBC histogram is not normal, a histogram error flag is added to the corresponding parameter of the analysis value. Those histogram error flags are listed in the order of higher priority. When two or more flags are applicable to a parameter, the highest-priority flag is used. RL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable cause is the effect of noise, RBC morphological change, platelet coagulation, or the like. RU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable cause is the effect of noise. MP: Two or more peaks in histogram. DW: Particle distribution width error for 20% frequency with the peak taken as 100%. When the 20% frequency does not cross the histogram two times, this flag is attached. • Matching of eight kinds of RBC histogram error flags RBC Histogram Error Flag Output [1] [2] [1]: Output flag to LCD screen, printer. [2]: Output flag to host computer. O: • When analysis results of LD and UD are normal • In the case of DW, when RDW-SD could be analyzed • In the case of MP, when RBC histogram has a single peak High: Frequencies of LD and UD are higher than the range ×: • In the case of DW, when RDW-SD could not be analyzed • In the case of MP, when RBC histogram has two or more peaks : Any of "O ," "×," and "High" is applicable. Case No. LD UD DW MP RBC HCT MCV MCH MCHC PLT RDW -SD HOST 1A 1B 1C 2A 2B 2C 3 4 High High High O O O O O High High High O O O × × O O × O O × O × RL RL RL RU RU RU RL RL RL RU RU RU RL RL RL RU RU RU RL RL RL RU RU RU RL RL RL RU RU RU RL RL RL RU RU RU RL DW MP RU DW MP DW MP RDW -CV RL RL MP RU RU MP MP 1 1 1 2 2 2 3 4 O × Table 9-6-2: RBC Histogram Error Flags NOTE: • Since CBC8 parameters only are output in the pre-diluted mode, a flag is not output to RDW-SD or RDW-CV.
  • 272. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 9-23 1 ) 1A Histogram with high frequency for LD RBC, HCT, MCV, MCH, MCHC, PLT, and particle distribution width data parameters are flagged with RL. MCV and RDW-SD exceed the upper Patient Mark Limits, and MCHC falls below the lower Patient Mark Limits. • RBC Histogram Error - RL (1A) 3.57 11.5 41.8 +117.1 32.2 -27.5 +91.7 185 [×106 /µL] [g/dL] [%] [fL] [pg] [g/dL] [fL] [×103 /µL] RBC 250200100 [fL] RBC HGB HCT MCV MCH MCHC RDW-SD PLT RL RL RL RL RL RL RL Figure 9-6-15: RBC Histogram Error - RL (1A) 2 ) 1B High frequency for LD with 20% particle distribution width error RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RL. Of the particle distribution width data, RDW-CV is flagged with RL and its data are output. RDW-SD parameter is flagged with DW and its data are not output. 3 ) 1C High LD with two or more peaks RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RL. RDW-CV is flagged with MP and its data are output, while RDW-SD is flagged with MP but its data are not output. 4 ) 2A Frequency high for UD RBC, HCT, MCV, MCH, MCHC, PLT, and particle distribution width data parameters are flagged with RU. In this instance, flags to indicate that their data are out of Patient Mark Limits are added to MCV, MCHC, and RDW-SD. • RBC Histogram Error - RU (2A) 3.57 11.5 41.8 +117.1 32.2 -27.5 +91.7 185 RBC [×106 /µL] [g/dL] [%] [fL] [pg] [g/dL] [fL] [×103 /µL] 250200100 [fL] RBC HGB HCT MCV MCH MCHC RDW-SD PLT RU RU RU RU RU RU RU Figure 9-6-16: RBC Histogram Error - RU (2A)
  • 273. FUNCTIONAL DESCRIPTION 9-24 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 5 ) 2B High UD with 20%-frequency distribution width error RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged. Out of the particle distribution width data, RDW-CV is flagged with RU and its data are output. RDW-SD is flagged with DW and its data are not output. In this instance, MCV and MCHC are out of Patient Mark Limits. • RBC Histogram Error - RU, DW (2B) 3.57 11.5 52.9 +148.2 32.2 -21.7 ---.- 185 RBC [×106 /µL] [g/dL] [%] [fL] [pg] [g/dL] [fL] [×103 /µL] 250200100 [fL] RBC HGB HCT MCV MCH MCHC RDW-SD PLT RU RU RU RU RU DW RU Figure 9-6-17: RBC Histogram Error - RU, DW (2B) 6 ) 2C High UD with two or more peaks RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RU. As to particle distribution width data, RDW-CV is flagged with MP and its data are output, while RDW-SD is also flagged with MP but its data are not output. 7 ) 3 20%-frequency particle distribution width error RBC, HCT, MCV, MCH, MCHC, and PLT parameters are not flagged. As to the particle distribution width data, RDW-CV data are output without flagging, while RDW-SD data are flagged with DW and their data are not output. 8 ) 4 Two or more peaks RBC, HCT, MCV, MCH, MCHC, and PLT parameters are not flagged. As to the particle distribution width data, RDW-CV data are output with MP flag. RDW-SD is flagged with MP and its data are not output. In this instance, RDW- CV is out of Patient Mark Limits. • RBC Histogram Error - MP (4) 4.80 14.2 41.5 86.5 29.6 -34.2 +33.3 216 RBC [×106 /µL] [g/dL] [%] [fL] [pg] [g/dL] [%] [×103 /µL] 250200100 [fL] RBC HGB HCT MCV MCH MCHC RDW- CV PLT MP Figure 9-6-18: RBC Histogram Error - MP (4)
  • 274. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 9-25 4 . Platelet Histogram Error Flag When the platelet histogram is not normal, a histogram error flag is added to the corresponding parameter of the analysis value. Those histogram error flags - used with the particle distribution analysis unit mounted, are listed in the order of higher priority. When two or more flags are applicable to a parameter, the highest priority flag is used. PL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable cause is the effect of noise and etc. PU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable cause is the effect of platelet agglutination, noise interference, and etc. MP: Two or more peaks in histogram DW: Particle distribution width error for 20% frequency with the peak taken as 100%. When the 20% frequency does not cross the histogram two times, this flag is attached. • Matching of eight kinds of platelet histogram error flags Platelet Histogram Error Flag Output [1] [2] [1]: Output flag to LCD screen, printer. [2]: Output flag to host computer. O: • When analysis results of LD and UD are normal • In the case of MP, when PLT histogram has a single peak High: Frequencies of LD and UD are higher than the range. ×: • In the case of MP, when PLT histogram has two or more peaks : Any of "O ," "×," and "High" is applicable. Case No. LD UD DW MP PLT MPV HOST 1A 1B 1C 2A 2B 2C 3 4 High High High O O O O O High High High O O O × × O O × O O × O × PL PL PL PU PU PU PL PL PL PU PU PU DW MP 1 1 1 2 2 2 3 4 O × Table 9-6-3: Platelet Histogram Error Flags NOTE: • Since CBC8 parameters only are output in the pre-diluted mode, flag output is limited to a PLT parameter.
  • 275. FUNCTIONAL DESCRIPTION 9-26 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 1 ) 1A High frequency for LD PLTM and MPV parameters are flagged with PL. • Platelet Histogram Error - PL (1A) 211 12.5 9.3 -22.6 PLT [×103 /µL] [fL] [fL] [%] 302010 [fL] PLT PDW MPV P-LCR PL PL PL PL Figure 9-6-19: Platelet Histogram Error - PL (1A) 2 ) 1B High LD with 20%-frequency distribution width error PLT parameter is flagged with PL. MPV is flagged with PL and its data is not output. 3 ) 1C High LD with two or more peaks PLT parameter is flagged with PL. MPV is flagged with PL and its data is not output. 4 ) 2A High UD PLT and MPV parameters are flagged with PU. 5 ) 2B High UD with 20%-frequency particle distribution width error PLT parameter is flagged with PU. MPV is flagged with PU and its data is not output. • Platelet Histogram Error - PU (2B) 171 ---.- ---.- ---.- PLT [×103 /µL] [fL] [fL] [%] 302010 [fL] PLT PDW MPV P-LCR PU DW PU PU Figure 9-6-20: Platelet Histogram Error - PU (2B)
  • 276. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 9-27 6 ) 2C High UD with two or more peaks PLT parameter is flagged with PU. MPV is flagged with PU and its data is not output. 7 ) 3 20%-frequency particle distribution width error PLT is not flagged. MPV is flagged with DW and its data is not output. • Platelet Histogram Error - DW (3) 91 ---.- ---.- ---.- PLT [×103 /µL] [fL] [fL] [%] 302010 [fL] PLT PDW MPV P-LCR DW DW DW Figure 9-6-21: Platelet Histogram Error - DW (3) 8 ) 4 Two or more peaks PLT is not flagged. Other parameters are flagged with MP and their data are not output. • Platelet Histogram Error - MP (4) 155 ---.- ---.- ---.- PLT [×103 /µL] [fL] [fL] [%] 302010 [fL] PLT PDW MPV P-LCR MP MP MP Figure 9-6-22: Platelet Histogram Error - MP (4)
  • 277. FUNCTIONAL DESCRIPTION 9-28 Sysmex KX-21N Operator’s Manual -- October 1999 7 . ELECTRIC SYSTEM The microprocessor in the main unit controls the hydraulic system's solenoid valves and master valves, thus regulating the flow of samples, reagents, and waste in the hydraulic system. Electric signals received from various transducers go through the analogue circuit for electrical waveform-processing, and to the microcomputer. The microcomputer converts the analogue signals into digital signals for the calculation. The WBC, RBC, and PLT cell signals are sent to the respective waveform-processing circuits in the analogue circuit, where the noise in signals is eliminated to acquire the required cell signals only. The microcomputer converts the A/D-converted cell signals into particle distribution data, and outputs them to the printer or to the host computer. To calculate HGB, absorbance of only the diluent (background) is deducted from samples' absorbance. The beam that has passed through the fluid is detected by the photo diode. And the signals is photoelectrically converted, A/D converted, and then sent to the HGB counting circuit for the calculation of the absorbance.
  • 278. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-29 Electric Diagram WBC Transducer WBCDetection Circuit WBC Amplification Waveform Processing Circuit RBC,PLT Transducer RBC,PLT DetectionCircuit HGB Transducer HGB Amplification Circuit WBCCountingCircuit RBCCountingCircuit PLTCountingCircuit HGBCountingCircuit WBCA-D Conversion Circuit RBCA-D Conversion Circuit PLTA-D Conversion Circuit Pressure Monitoring Unit Driver Solenoid Motor Input- Output Interface RBC Amplification Waveform Processing Circuit PLT Amplification Waveform Processing Circuit HGB Conversion Circuit MicrocomputerCircuit WBCCalculator RBCCalculator AnalogueCircuit LCD Interface Interface Printer Interface LCDscreen PanelSwitch Built-inPrinter MainUnit Transducer PDAUnit SerialInterface Memory Processor (Computer) DisplayUnit Operation Unit Built-in Printer Interface Interface Interface Interface Interface Interface Bus HandHeldBarcodeReader GraphicPrinter DataPrinter (Option) (Option) (Option) Figure 9-7-1: Electric Diagram Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 279. FUNCTIONAL DESCRIPTION 9-30 Sysmex KX-21N Operator’s Manual -- October 1999 8 . NAMES AND FUNCTIONS OF INSTRUMENTS 8.1 Front Panel Sysmex 4) Graphic Screen 5) Panel Keyboard 1) Front Cover 2) Sample Probe 3) START switch Figure 9-8-1: Front Panel 1 ) Front Cover The front cover can be opened to the right by your hands. It is opened to replace lyse containers, check or clean the interior of measuring unit. 2 ) Sample Probe The sample probe is used to aspirate sample in the whole blood and pre-diluted modes. 3 ) START Switch This switch starts whole blood mode analysis and pre-diluted mode analysis. 4 ) Graphic Screen This displays Sample Nos., analysis results, instrument status, error messages, etc. For detail, refer to Chapter 1, Section 8: GRAPHIC SCREEN. 5 ) Panel Keyboard This keyboard allows basic operations such as entry of Sample No. and selection of analysis parameters. For detail, refer to Chapter 1, Section 7: PANEL KEYBOARD.
  • 280. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-31 8.2 Front Interior 1) Detector Block 5) Built-in Printer 2) Sample Rotor Valve (SRV) 3) Rinse Cup 4) WBC/HGB Lyse (STROMATOLYSER-WH) Figure 9-8-2: Front Interior 1 ) Detector Block Incorporates RBC transducer, WBC transducer, and HGB flow cell. 2 ) Sample Rotor Valve (SRV) Makes volumetric measurement of aspirated blood. 3 ) Rinse Cup Cleans the sample probe. 4 ) WBC/HGB Lyse (STROMATOLYSER-WH) Reagent to measure WBC/HGB 5 ) Built-in Printer Prints analysis data, error messages, etc.
  • 281. FUNCTIONAL DESCRIPTION 9-32 Sysmex KX-21N Operator’s Manual -- October 1999 8.3 Right Side Panel 2) Power Supply Switch 1) Fuse 3) Power Supply Connector Figure 9-8-3: Right Side Panel 1 ) Fuse Replace with provided time-lag type fuse. The rating will be different depending on the instrument specification. Specification Part No. Description Fuse Type 117 VAC 266-5109-1 Fuse 250 V 3.15 A ST4-3.15A-N1 Time Lag 220/240 VAC 266-5292-6 Fuse 250 V 2 A No. 19195 Time Lag • To avoid risk of electrical shock, disconnect the power cord before replacing the fuses. • For continued protection against risk of fire, use the fuse of specified type and rating. 2 ) Power Supply Switch Turns on and off the main unit power supply. CAUTION: • Avoid turning this switch ON and OFF continuously in short duration. This will overload the fuse and may cause fuse blown. 3 ) Power Supply Connector Using the furnished power supply cord, this connector supplies power from the outlet. WARNING CAUTION
  • 282. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-33 8.4 Left Side Panel 3) 0.0333 MPa Bellows Unit 4) Air filter 2) 0.05 MPa Regulator 1) Trap Chamber Figure 9-8-4: Left Side Panel 1 ) Trap Chamber Prevents reagent, etc. from flowing into the vacuum pump of the compressor when an error occurs with the instrument. 2 ) 0.05 MPa Regulator Regulates pressure to 0.05 MPa. 3 ) 0.0333 MPa Bellows Unit Regulates vacuum to 0.0333 MPa vacuum. 4 ) Air Filter Prevents dirt and dust from entering the bellows. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 283. FUNCTIONAL DESCRIPTION 9-34 Sysmex KX-21N Operator’s Manual -- October 1999 8.5 Left Side Interior 1) Waste Chamber 2) Pneumatic Unit Figure 9-8-5: Left Side Interior 1 ) Waste Chamber Collects wastes from transducers and mixing chambers. 2 ) Pneumatic Unit Supplies pressure and vacuum. CAUTION: • Do no open the left face unless your Sysmex service representative asks you to.
  • 284. FUNCTIONAL DESCRIPTION Sysmex KX-21N Operator’s Manual -- October 1999 9-35 8.6 Rear Panel 1) ID Reader Connector 2) GP Connector 3) DP Connector 5) Drain Outlet Nipple 6) Diluent Inlet Nipple (CELLPACK) 4) Serial Interface 7) Card Slot Protective Cover Figure 9-8-6: Rear Panel 1 ) ID Reader Connector Connects an optional hand held barcode reader. 2 ) GP Connector Connects an optional graphic printer. 3 ) DP Connector Connects an optional data printer. 4 ) Serial Interface Connector for communicating with the host computer. 5 ) Drain Outlet Nipple This nipple drains waste. It connects with the drain sewer or waste tank. 6 ) Diluent Inlet Nipple (CELLPACK) This nipple aspirates diluent. It connects with the diluent container. 7 ) Card Slot Protective Cover This is a protective cover for the slot to insert the program card. Sysmex KX-21N Operator’s Manual -- Revised May 2003
  • 285. Sysmex KX-21N Operator’s Manual -- October 1999 CHAPTER 10 INSTRUMENT SETUP 1. INTRODUCTION ............................................................... 10-1 2. SYSTEM SETUP................................................................ 10-3 3. DATE/TIME SETTINGS ....................................................... 10-8 4. PATIENT LIMIT ...............................................................10-11 5. QC SETTINGS ................................................................. 10-14 6. HOST SETTINGS..............................................................10-17 7. PRINTER SETTINGS.........................................................10-22 7.1 DP Output Settings.......................................................10-23 7.2 GP/LP Output Settings ..................................................10-25 7.3 IP Output Settings........................................................10-27 8. ID READER SETTINGS ......................................................10-30 9. PASSWORD SETTINGS .....................................................10-32 10. PRINT SET VALUES .........................................................10-35 11. PERIPHERAL SETTINGS ...................................................10-36 12. FACTORY SETTINGS........................................................10-38
  • 286. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-1 1 . INTRODUCTION Your Sysmex service representative performs the settings of the instrument at time of installation. The settings can be changed by using this program. This chapter describes how to use this setting program. System Setup Sets up the instrument system status. Date/Time Sets date/time of the built-in clock. Patient Limit Sets upper and lower Patient Mark Limits to check for error in analysis data. QC Settings Selects between X control and L-J control as the QC method, and sets the output method of QC data. Host Settings Sets the interface conditions for transferring data to the host computer. Printer Settings Sets the output selection and output conditions of the built-in printer or the external printers (Data Printer, Graphic Printer: option). ID Reader Settings Sets whether to Use or Not Use of the hand held barcode reader (option). Password Settings Sets and changes the password. Print Set Values Prints all the contents of the settings by the built-in printer. Peripheral Setting Sets whether to Use or Not Use of the printer, hand held barcode reader (option), or the host computer output. CAUTION: • The setting program can be run only when the instrument is ready. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 287. INSTRUMENT SETUP 10-2 Sysmex KX-21N Operator’s Manual -- October 1999 NOTE: • Menu selection method (1) Cursor selection (explained in this Manual) Using [ ] or [ ] key, move the cursor to a desired program and press [ENTER] key to set. (2) Direct key selection Using the numeric keys, enter a menu number of the program you want to set, thus selecting the menu. The menu number is displayed on the Menu screen. • Change set values and move the cursor to the next parameter using [ ] or [ ] key ([ ] or [ ] key also can be used in Patient Limit setting) or press [ENTER] key. This sets the settings. • When the password is set, the following programs cannot be used if the password is not input. • System Setup • Patient Limit • QC Settings • Password Settings
  • 288. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-3 2 . SYSTEM SETUP This program is used to set unit system, display language, and WBC analysis parameters. How to Setup System Status (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "6: Settings." (3) Press [ENTER] key. The Setting Menu screen appears. *Settings* 1:System Setup 2:Date/Time 3:Patient Limit 4:QC Settings 5:Host Settings 6:Printer Settings 7:ID Reader Settings 8:Password Settings 9:Print Set Values Figure 10-2-1: Setting Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "1: System Setup."
  • 289. INSTRUMENT SETUP 10-4 Sysmex KX-21N Operator’s Manual -- October 1999 (5) Press [ENTER] key. The current setting status is displayed on the System Setup screen. Units Type2 Parameter Naming LYM% Language English *System Setup* Press [SELECT] to exit. Figure 10-2-2: System Setup Screen NOTE: • When the password is set, the Password Input screen appears, and input the password, and then press [ENTER] key (6) Using [ ] or [ ] key, move the cursor to select the desired set parameter. For System Setup, three parameters can be set. (7) Using [ ] or [ ] key, select the content of settings. Each time you press the key, the content of settings changes. (8) Press [ENTER] key. The content of settings is set and the cursor moves to the next set parameter. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. 1 ) Unit Setting Sets the unit system for displaying analysis data. The unit can be selected from the following six kinds: Settings Unit System Settings Unit System Type 1 For Japan Type 4 Dutch SI Type 2 For General Export Type 5 Standard SI Type 3 Canada SI Type 6 Hong Kong SI Table 10-2-1: Unit Setting
  • 290. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 10-5 For the detail of unit system, refer to the following table: For Japan For General Export Canada SI Item Decimal point Unit Decimal point Unit Decimal point Unit WBC RBC HGB HCT MCV MCH MCHC PLT LYM% MXD% NEUT% LYM# MXD# NEUT# RDW-SD RDW-CV MPV #### #### ###.# ###.# ###.# ###.# ###.# ###.# ###.# ###.# ###.# #### #### #### ###.# ###.# ###.# ×102 /µL ×104 /µL g/dL % fL pg g/dL ×104 /µL % % % ×102 /µL ×102 /µL ×102 /µL fL % fL ###.# ##.## ###.# ###.# ###.# ###.# ###.# #### ###.# ###.# ###.# ###.# ###.# ###.# ###.# ###.# ###.# ×103 /µL ×106 /µL g/dL % fL pg g/dL ×103 /µL % % % ×103 /µL ×103 /µL ×103 /µL fL % fL ###.# ##.## #### #.### ###.# ###.# #### #### #.### #.### #.### ###.# ###.# ###.# ###.# #.### ###.# ×109 /L ×1012 /L g/L L/L fL pg g/L ×109 /L ×109 /L ×109 /L ×109 /L fL fL Dutch SI Standard SI Hong Kong SI Item Decimal point Unit Decimal point Unit Decimal point Unit WBC RBC HGB HCT MCV MCH MCHC PLT LYM% MXD% NEUT% LYM# MXD# NEUT# RDW-SD RDW-CV MPV ###.# ##.## ###.# #.### ###.# #### ###.# #### #.### #.### #.### ###.# ###.# ###.# ###.# #.### ###.# ×109 /L ×1012 /L mmol/L L/L fL amol mmol/L ×109 /L ×109 /L ×109 /L ×109 /L fL fL ###.# ##.## #### #.### ###.# ###.# #### #### #.### #.### #.### ###.# ###.# ###.# ###.# #.### ###.# ×109 /L ×1012 /L g/L fL pg g/L ×109 /L ×109 /L ×109 /L ×109 /L fL fL ###.# ##.## ###.# #.### ###.# ###.# ###.# #### ###.# ###.# ###.# ###.# ###.# ###.# ###.# ###.# ###.# ×109 /L ×1012 /L g/dL fL pg g/dL ×109 /L % % % ×109 /L ×109 /L ×109 /L fL % fL Table 10-2-2: Details of Unit System Sysmex KX-21N Operator’s Manual -- October 1999 N.A.
  • 291. INSTRUMENT SETUP 10-6 Sysmex KX-21N Operator’s Manual -- October 1999 2 ) Language Setting Set the language for displaying on the screen. The language can be selected from the eight kinds listed below: Settings Display language Japanese Japanese English English Chinese Chinese French French German German Spanish Spanish Italian Italian Portuguese Portuguese Table 10-2-3: Language Setting 3 ) Parameter Name Setting Set WBC analysis parameter names. The parameter can be selected from the following two kinds: Settings Analysis Parameter Name W-SCR W-SCR W-MCR W-LCR W-SCC W-MCC W-LCC LYM% LYM% MXD% NEUT% LYM# MXD# NEUT# Table 10-2-4: Parameter Name Setting NOTE: • The settings of language become valid from the next time you turn ON the instrument power.
  • 292. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-7 (9) When the setting of each parameter is completed, press [SELECT] key. The Setting Change Confirmation message appears. Change? Cont. Set Cancel Figure 10-2-3: Setting Change Confirmation Message (10) Using[ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the System Setup screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (11) Press [ENTER] to execute the selected process.
  • 293. INSTRUMENT SETUP 10-8 Sysmex KX-21N Operator’s Manual -- October 1999 3 . DATE/TIME SETTINGS This instrument displays date/time on analysis data, using the built-in clock. This program is used to set the date/time for the built-in clock and date format. How to Set Date/Time (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "6: Settings." (3) Press [ENTER] key. The Setting Menu screen appears. *Settings* 1:System Setup 2:Date/Time 3:Patient Limit 4:QC Settings 5:Host Settings 6:Printer Settings 7:ID Reader Settings 8:Password Settings 9:Print Set Values Figure 10-3-1: Setting Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "2: Date/Time." (5) Press [ENTER] key. The current setting status is displayed on the Date/Time screen. Date Format dd/mm/yyyy dd 31 mm 12 yy 1999 mm 59 hh 23 *Date/Time* Press [SELECT] to exit. Figure 10-3-2: Date/Time Screen (6) Using [ ] or [ ] key, move the cursor to select the desired set parameter.
  • 294. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-9 (7) Using [ ], [ ], or the numeric keys, set each parameter. In setting the date format, use [ ] or [ ] key. Year, month, day, hour, and minute are entered using the numeric keys. (8) Press [ENTER] key. The content of the settings is set and the cursor moves to the next set parameter. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. 1 ) Date Format Setting Using [ ] or [ ] key, select the date format. The date format can be selected from the following three types. It changes each time you press the key. Settings Example of display yyyy/mm/dd 1999/12/31 mm/dd/yyyy 12/31/1999 dd/mm/yyyy 31/12/1999 Table 10-3-1: Date Format Setting 2 ) Year Setting Enter in the dominical year using the numeric keys. 3 ) Month Setting Enter the numerical value of 1 - 12 using the numeric keys. 4 ) Day Setting Enter the numerical value of 1 - 31 using the numeric keys. 5 ) Hour Setting Enter the numerical value of 0 - 23 by 24-hour system with using the numeric keys 6 ) Minute Setting Enter the numerical value of 0 - 59 using the numeric keys
  • 295. INSTRUMENT SETUP 10-10 Sysmex KX-21N Operator’s Manual -- October 1999 (9) When the setting of each parameter is completed, press [SELECT] key. The date entered is checked and when there is no setting error, the Setting Change Confirmation message is displayed. If there is any setting error, the alarm sounds and the Setting Change Confirmation message is not displayed. NOTE: • About the date setting, the following items are checked: Leap year check: whether 2/29 is set in non-leap year Month/day check: whether 4/31, e.g., is set Change? Cont. Set Cancel Figure 10-3-3: Setting Change Confirmation Message (10) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the Date/Time screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (11) Press [ENTER] key to execute the selected process.
  • 296. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-11 4 . PATIENT LIMIT For Patient Limit, you can set Mark Limits. The Mark Limits are the values set to determine whether analysis values are within the normal range or not. This program can be used to set the upper and lower Mark Limits for each analysis parameter. When analysis data exceeds the upper Mark Limit, it is flagged with [+] mark, and when it exceeds the lower Mark Limit, it is flagged with [-] mark. Analysis data output to the built-in printer or the host computer is also attached with either marks. How to Set Mark Limits (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "6: Settings." (3) Press [ENTER] key. The Setting Menu screen appears. *Settings* 1:System Setup 2:Date/Time 3:Patient Limit 4:QC Settings 5:Host Settings 6:Printer Settings 7:ID Reader Settings 8:Password Settings 9:Print Set Values Figure 10-4-1: Setting Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "3: Patient Limit."
  • 297. INSTRUMENT SETUP 10-12 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. (5) Press [ENTER] key. The current setting status is displayed on the Patient Limit screen. LL UL HGB 8.0 17.0 g/dL RBC 2.50 5.50 ×106 /µL WBC 3.0 15.0 ×103 /µL MCV 86.0 110.0 fL HCT 26.0 50.0 % MCH 26.0 38.0 pg PLT 50 400 ×103 /µL MCHC 31.0 37.0 g/dL LYM% 5.0 55.0 % MXD% 1.0 20.0 % *Patient Limit* Press [SELECT] to exit. Figure 10-4-2: Patient Limit Screen NOTE: • When the password is set, the Password Input screen appears, and input the password, and then press [ENTER] key (6) Using [ ] or [ ] key, move the cursor to select the desired set parameter. NOTE: • Total 17 setting parameters of Patient Limit are displayed. But not all of them can be displayed in one screen at a time. Therefore, scroll the screen using [ ] or [ ] key. LL UL LYM# 0 0 ×103 /µL NEUT% 45.0 95.0 % MXD% 1.0 20.0 % NEUT# 0 0 ×103 /µL MXD# 0 0 ×103 /µL RDW-SD 37.0 54.0 fL PDW 9.0 17.0 % RDW-CV 11.0 16.0 % MPV 9.0 13.0 fL P-LCR 13.0 43.0 % *Patient Limit* Press [SELECT] to exit. Figure 10-4-3: Scrolling the Screen (7) Using [ ] or [ ] key, move the cursor to select LL (Lower Limit) or UL (Upper Limit).
  • 298. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-13 (8) Enter the settings using the numeric keys. (9) Press [ENTER] key. The content of settings is set and the cursor moves to the next set parameter. NOTE: • When [ ], [ ], [ ], or [ ] key is pressed after entering, the contents of settings are also set. • When both the upper and lower limits are set at "0," the judgment on patient limit is not executed. (10) When the setting of each parameter is completed, press [SELECT] key. When the set values are checked and there is no setting error, the Setting Change Confirmation message is displayed. In case Upper Limit < Lower Limit is set, the alarm sounds and the Setting Change Confirmation message is not displayed. Change? Cont. Set Cancel Figure 10-4-4: Setting Change Confirmation Message (11) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the Patient Limit screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (12) Press [ENTER] key to execute the selected process.
  • 299. INSTRUMENT SETUP 10-14 Sysmex KX-21N Operator’s Manual -- October 1999 5 . QC SETTINGS This program is used to set QC method and output method of QC data. Two kinds of QC methods are available with this instrument: X control and L-J control. Select either of them that suits your purpose. X Control: Control blood is subjected to two consecutive analyses and the mean of them is used as the QC data. This method causes little influence on reproducibility in analysis. L-J Control: This control uses the data from a single analysis of control blood as QC data. The control width in the L-J control is prone to influence in reproducibility in analysis, so that the control width is wider than in the case of X control. How to Set QC Settings (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "6: Settings." (3) Press [ENTER] key. The Setting Menu screen appears. *Settings* 1:System Setup 2:Date/Time 3:Patient Limit 4:QC Settings 5:Host Settings 6:Printer Settings 7:ID Reader Settings 8:Password Settings 9:Print Set Values Figure 10-5-1: Setting Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "4: QC Settings."
  • 300. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-15 (5) Press [ENTER] key. The current setting status is displayed on the QC Settings screen. Data Output Print *QC Settings* Press [SELECT] to exit. QC Method X Figure 10-5-2: QC Settings Screen NOTE: • When the password is set, the Password Input screen appears, and input the password, and then press [ENTER] key (6) Using [ ] or [ ] key, move the cursor to select the set parameter. QC settings can be made on three parameters. (7) Using [ ] or [ ] key, select the content of settings. The content of settings changes each time you press the key. (8) Press [ENTER] key. The content of setting is set and the cursor moves to the next analysis parameter. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. 1 ) QC Method Setting Set the QC method. The QC method can be selected from the following two kinds: 17 Settings QC Method X X Control L-J L-J Control Table 10-5-1: QC Method Setting
  • 301. INSTRUMENT SETUP 10-16 Sysmex KX-21N Operator’s Manual -- October 1999 2 ) Data Output Setting Set the QC data output method. The QC data output can be selected from the following four kinds: Settings QC data output None Not output Print Print on built-in printer Host Output to host computer Print, Host Print on built-in printer and output to host computer Table 10-5-2: Data Output Setting NOTE: • For print format to the built-in printer, refer to Chapter 5, Section 2.6: Execute X Control or Chapter 5, Section 2.7: Execute L-J Control. • For output format to the host computer, refer to Appendix B: Technical Information. • The data output format for quality control differs from the format for usual analysis. (9) When the setting for each parameter is completed, press [SELECT] key. The Setting Change Confirmation message appears. Change? Cont. Set Cancel Figure 10-5-3: Setting Change Confirmation Message (10) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the QC Settings screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (11) Press [ENTER] key to execute the selected process.
  • 302. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-17 6 . HOST SETTINGS This program is used to set the interface conditions for transferring data to the host computer. How to Set Host Output (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "6: Settings." (3) Press [ENTER] key. The Setting Menu screen appears. *Settings* 1:System Setup 2:Date/Time 3:Patient Limit 4:QC Settings 5:Host Settings 6:Printer Settings 7:ID Reader Settings 8:Password Settings 9:Print Set Values Figure 10-6-1: Setting Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "5: Host Settings." (5) Press [ENTER] key. The current setting status is displayed on the Host Settings screen. Auto Output On Output Format K-1000 Data Length 7bits Baud Rate 2400 Stop Bit 2bits Protocol Class A Interval 2 RTS/CTS Ignore Parity Check Even *Host Settings* Press [SELECT] to exit. Connect Not Use Figure 10-6-2: Host Settings Screen
  • 303. INSTRUMENT SETUP 10-18 Sysmex KX-21N Operator’s Manual -- October 1999 (6) Using [ ] or [ ] key, move the cursor to select the desired set parameter. For Host Settings, twelve parameters can be set. NOTE: • There are 12 setting parameters for Host Settings, but all the setting parameters cannot be listed in one screen, so scroll the screen with [ ] key or [ ] key. RDW Output RDW-CV ID Padding 0 Padding *Host Settings* Press [SELECT] to exit. Figure 10-6-3: Host Settings Screen (7) Using [ ] or [ ] key, select the condition. The condition changes each time you press the key. (8) Press [ENTER] key. The content of settings is set and the cursor moves to the next set parameter. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. 1 ) Connect Settings Set whether to connect the host computer or not. Settings Connection Use Connect Not Use Not Connect Table 10-6-1: Host Output Settings Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 304. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-19 2 ) Output Format Settings Set output format of analysis data to the host computer. This can be selected from the following three kinds: Settings Output Format KX-21N Standard output format of KX-21N Refer to Appendix B: Technical Information. K-1000 ASCII data is output in the published format. Refer to Appendix B: Technical Information. K-DPS Binary data is output for connecting with K-DPS. Data format is not published. Table 10-6-2: Output Format Settings 3 ) Auto Output Settings Set whether to make auto output to the host computer or not. Settings Auto Output On Auto Output Off Not Auto Output Table 10-6-3: Auto Output Settings 4 ) Baud Rate Settings Set the baud rate. This can be selected from the following four kinds: Settings Baud Rate 1200 1200 bps 2400 2400 bps 4800 4800 bps 9600 9600 bps Table 10-6-4: Baud Rate Settings 5 ) Data Length Settings Set the data length. This can be selected from the following two kinds: Settings Data Length 7 bits 7 bits 8 bits 8 bits Table 10-6-5: Data Length Settings
  • 305. INSTRUMENT SETUP 10-20 Sysmex KX-21N Operator’s Manual -- October 1999 6 ) Stop Bit Settings Set the stop bit. This can be set selected from the following two kinds: Settings Stop Bit 1 bit 1 bit 2 bits 2 bits Table 10-6-6: Stop Bit Settings 7 ) Parity Check Settings Set the parity check method. This can be set selected from the following three kinds: Settings Parity Check None None Odd Odd Even Even Table 10-6-7: Parity Check Settings 8 ) Protocol Settings Set the protocol. This can be set selected from the following two kinds: Settings Protocol Class A Class A Class B Class B Table 10-6-8: Protocol Settings 9 ) Transmission interval Settings Select a transmission interval from the following: Settings Interval 0 0 second 2 2 seconds 3 3 seconds 5 5 seconds 7 7 seconds 10 10 seconds 15 15 seconds Table 10-6-9: Transmission Interval
  • 306. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-21 10) RTS/CTS control Settings Specify whether or not the RTS/CTS flow control takes place. Settings RTS/CTS control Refer Allowed Ignore Not allowed Table 10-6-10: RTS/CTS control 11) RDW Output When the K-1000 format is selected, RDW Output can be set by selecting from following two types. Settings RDW Output RDW-SD Outputs RDW-SD RDW-CV Outputs RDW-CV Table 10-6-11: RDW Output 12) ID Padding The sample ID can be set whether to make padding by selecting from following two types. Settings Padding 0 Padding Allowed 0 padding None Not allowed 0 padding Table 10-6-12: ID Padding NOTE: • ID Padding will set how to pad the most significant digits output to the host computer, if the number of the sample ID digits is 14 or less. ex) When the Sample ID No. is “12345” 0 Padding “000000000012345” None “∆∆∆∆∆∆∆∆∆∆12345” “∆” means “a space”. (9) When the setting of each parameter is completed, press [SELECT] key. The Setting Change Confirmation message appears. Change? Cont. Set Cancel Figure 10-6-4: Setting Change Confirmation Message Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 307. INSTRUMENT SETUP 10-22 Sysmex KX-21N Operator’s Manual -- October 1999 (10) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the Host Settings screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (11) Press [ENTER] key to execute the selected process. 7 . PRINTER SETTINGS This program is used to set the output selection and output conditions for the built-in printer or the external printers (Data Printer, Graphic Printer). How to Set Printer Output (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "6: Settings." (3) Press [ENTER] key. The Setting Menu screen appears. *Settings* 1:System Setup1:System Setup 2:Date/Time 3:Patient Limit 4:QC Settings 5:Host Settings 6:Printer Settings 7:ID Reader Settings 8:Password Settings 9:Print Set Values Figure 10-7-1: Setting Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "6: Printer Settings." (5) Press [ENTER] key. The Printer Settings Menu screen appears. 1 :1 : DP 2 : GP/LP 3 : IP *Settings* Figure 10-7-2: Printer Settings Menu Screen Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 308. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-23 NOTE: • When you press [ENTER] key on this screen, the screen returns to the Analysis screen. (6) Using [ ] or [ ] key, move the cursor and select the printer to be set. (7) Press [ENTER] key. The Printer Settings screen for the selected printer appears. For how to set the printer output of DP (Data Printer), refer to Section 7.1: DP Output Settings in this chapter. For how to set the printer output of GP/LP (Graphic Printer), refer to Section 7.2: GP/LP Output Settings in this chapter. For how to set the printer output of IP (Built-in Printer), refer to Section 7.3: IP Output Settings in this chapter. 7.1 DP Output Settings Select "1: DP" on Printer Settings Menu screen and press [ENTER] key. The DP Settings screen for Data Printer appears. DP Auto Output On *DP* Press [SELECT] to exit. ConnectConnect Use Figure 10-7-3: DP Settings Screen (1) Using [[ ] or [ ] key, move the cursor to select the desired setting parameter. In the output setting for the data printer, you can set two parameters. (2) Using [ ] or [ ] key, select the content of settings. The content of settings changes each time you press the key. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 309. INSTRUMENT SETUP 10-24 Sysmex KX-21N Operator’s Manual -- October 1999 (3) Press [ENTER] key. The content of setting is set and the cursor moves to the next analysis parameter. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. 1 ) Connect Settings Set whether to use the data printer or not. Settings Connection Use Connect Not Use Not Connect Table 10-7-1: Data Printer Settings 2 ) DP Auto Output Settings Whether the analysis data is output to the data printer by the automatic operation can be set. Settings Auto Output On Auto Output Off Not Auto Output Table 10-7-2: Auto Output Settings (4) When the setting of each parameter is completed, press [SELECT] key. The Setting Change Confirmation message appears. Change? Cont. Set Cancel Figure 10-7-4: Setting Change Confirmation Message (5) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the DP Settings screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (6) Press [ENTER] key to execute the selected process. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 310. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-25 7.2 GP/LP Output Settings Select "2: GP/LP" on Printer Settings Menu screen and press [ENTER] key. The GP/LP Settings screen for Graphics Printer appears. Printer type Type1 *GP/LP* Press [SELECT] to exit. Connect Use GP Auto Output On Figure 10-7-5: GP/LP Settings Screen (1) Using [[ ] or [ ] key, move the cursor to select the desired setting parameter. In the output setting for the data printer, you can set three parameters. (2) Using [ ] or [ ] key, select the condition. The condition changes each time you press the key. (3) Press [ENTER] key. The content of setting is set and the cursor moves to the next analysis parameter. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. 1 ) Connect Settings Set whether to use the graphic printer or not. Settings Connection Use Connect Not Use Not Connect Table 10-7-3: Graphic Printer Settings
  • 311. INSTRUMENT SETUP 10-26 Sysmex KX-21N Operator’s Manual -- October 1999 2 ) Printer type Settings The type of graphic printer to be connected can be set by selecting from following two types. Settings Printer type Type 1 Printer of ESC/P system Type 2 Printer of PCL5 system Table 10-7-4: Printer type Settings 3 ) GP Auto Output Settings Whether the analysis data is output to the graphic printer by the automatic operation can be set. Settings Auto Output On Auto Output Off Not Auto Output Table 10-7-5: Auto Output Settings (4) When the setting of each parameter is completed, press [SELECT] key. The Setting Change Confirmation message appears. Change? Cont. Set Cancel Figure 10-7-6: Setting Change Confirmation Message (5) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the GP/LP Settings screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (6) Press [ENTER] key to execute the selected process.
  • 312. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-27 7.3 IP Output Settings Select "3: IP" on Printer Settings Menu screen and press [ENTER] key. The IP Settings screen for Built-in Printer appears. Print Format Type1 Press [SELECT] to exit. *IP* Print Condition All Data Connect Use Figure 10-7-7: IP Settings Screen (1) Using [ ] or [ ] key, move the cursor to select the set parameter. Printer settings can be made on three parameters. (2) Using [ ] or [ ] key, select the condition. The condition changes each time you press the key. (3) Press [ENTER] key. The content of settings is set and the cursor moves to the next set parameter. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. 1 ) Connect Settings Set whether to use the built-in printer or not. Settings Connection Use Connect Not Use Not Connect Table 10-7-6: Built-in Printer Settings
  • 313. INSTRUMENT SETUP 10-28 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 2 ) Print Condition Settings Set the auto print condition for the built-in printer. This can be selected from the following three kinds: Settings Auto Print Conditions All Data Print All Samples Abnormal Data Print Abnormal Data Only None Not Auto Print Table 10-7-7: Print Condition Settings NOTE: • Data printed as abnormal data: • Data in which analysis error occurred • Data in which noise error occurred • Data with flags other than Mark Limits • Data with histogram flag • Data out of the linearity limit • For print conditions of QC data, refer to Chapter 10, Section 5: QC Settings. 3 ) Print Format Settings Set the print format for the built-in printer. This can be selected from the following three kinds: Settings Print Format Type 1 Print 17 parameters + histograms. Type 2 Print 17 parameters. Type 3 Print 8 parameters. Table 10-7-8: Print Format Settings NOTE: • For print format, refer to Chapter 2, Section 5.2 Printing of Analysis Result. • For print format for quality control, refer to Chapter 5, Section 2.6: Execute X Control or Chapter 5, Section 2.7: Execute L-J Control.
  • 314. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-29 (4) When the setting of each parameter is completed, press [SELECT] key. The Setting Change Confirmation message appears. Change? Cont. Set Cancel Figure 10-7-8: Setting Change Confirmation Message (5) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the Printer Settings screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (6) Press [ENTER] key to execute the selected process.
  • 315. INSTRUMENT SETUP 10-30 Sysmex KX-21N Operator’s Manual -- October 1999 8 . ID READER SETTINGS This program can set whether to Use or Not Use of the hand held barcode reader (option) which is for reading the sample IDs. How to Set ID Reader (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "6: Settings." (3) Press [ENTER] key. The Setting Menu screen appears. *Settings* 1:System Setup 2:Date/Time 3:Patient Limit 4:QC Settings 5:Host Settings 6:Printer Settings 7:ID Reader Settings 8:Password Settings 9:Print Set Values Figure 10-8-1: Setting Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "7: ID Reader Settings." (5) Press [ENTER] key. The current setting status appears on ID Reader Settings screen. Press [SELECT] to exit. *IP Reader* Connect Use Figure 10-8-2: ID Reader Settings Screen Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 316. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-31 (6) Using [ ] or [ ] key, select "Use" or "Not Use." The display of "Use" and "Not Use" changes whenever the key is pressed. (7) Press [ENTER] key. The setting contents can be confirmed. (8) Press [SELECT] key. The Setting Change Confirmation message appears. Change? Cont. Set Cancel Figure 10-8-3: Setting Change Confirmation Message (9) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the Printer Settings screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (10) Press [ENTER] key to execute the selected process.
  • 317. INSTRUMENT SETUP 10-32 Sysmex KX-21N Operator’s Manual -- October 1999 9 . PASSWORD SETTINGS This program can set and change the password. NOTE: • In order to execute under the control of the instrument manager, an important program is protected by the password. • For the programs protected by the password, refer to Chapter 1, Section 14: MENU TREE. • When the program protected by the password is executed, the Password Input window appears. When the set password is input, and [ENTER] key is pressed, the program is executed. How to Set Password (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "6: Settings." (3) Press [ENTER] key. The Setting Menu screen appears. *Settings* 1:System Setup 2:Date/Time 3:Patient Limit 4:QC Settings 5:Host Settings 6:Printer Settings 7:ID Reader Settings 8:Password Settings 9:Print Set Values Figure 10-9-1: Setting Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "8: Password Settings."
  • 318. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-33 (5) Press [ENTER] key. The Password Settings screen appears. New Password [ ] Enter Again [ ] Press [SELECT] to exit. *Password* Figure 10-9-2: Password Settings Screen NOTE: • When you have already set the password, the Password Input screen is displayed, and then input a correct password. Password [ ] Press [SELECT] to exit. *Password* Figure 10-9-3: Password Input Screen In the input of a correct password, and pressing [ENTER] key, the Password Settings screen appears. • On the screen, all the values of the password display part are displayed by "*". The purpose of this is to make other people not seen the password when setting it. • Press [SELECT] key to discontinue the password setting, and to return to Analysis screen.
  • 319. INSTRUMENT SETUP 10-34 Sysmex KX-21N Operator’s Manual -- October 1999 (6) Input the set password to the New Password column with numeric keys, and press [ENTER] key. Set the password up to 10 digits by using the figure (0-9) or the hyphen (-). If [ENTER] key is pressed, the status becomes the input waiting for the Enter Again column. NOTE: • When you do not set the password, the password can be deleted by the following operating. • Press [ENTER] key at the status of no password input. (7) Again, input the set password to the Enter Again column with numeric keys, and press [ENTER] key. If the password input to the New Password column and the password input to the Enter Again are different, set over again from the input of the New Password column. If they are the same, the Setting Change Confirmation message appears. Change? Cont. Set Cancel Figure 10-9-4: Setting Change Confirmation Message (8) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the Printer Settings screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (9) Press [ENTER] key. The Setting Menu screen appears. NOTE: • When the password has been forgotten, contact Sysmex service representative. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 320. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-35 10. PRINT SET VALUES To backup the set values, all the contents of the settings can be printed by the built-in printer. How to Print Set Values (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. (2) Using [ ] or [ ] key, move the cursor to select "6: Settings." (3) Press [ENTER] key. The Setting Menu screen appears. *Settings* 1:System Setup 2:Date/Time 3:Patient Limit 4:QC Settings 5:Host Settings 6:Printer Settings 7:ID Reader Settings 8:Password Settings 9:Print Set Values Figure 10-10-1: Setting Menu Screen (4) Using [ ] or [ ] key, move the cursor to select "9: Print Set Values." (5) Press [ENTER] key. The built-in printer starts printing all the set values. NOTE: • If any faulty operation occurs, contact your Sysmex service representative. Keep the printed contents of the settings in good condition because the service representative may have to confirm the contents of settings. • When the QC method of the QC Setting is “X”, it is printed as “X”. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 321. INSTRUMENT SETUP 10-36 Sysmex KX-21N Operator’s Manual -- October 1999 11. PERIPHERAL SETTINGS When you want to temporarily cancel external output due to error occurrence, use this program to set "Use" or "Not use" of the built-in/external printer, host computer output or the hand held barcode reader. NOTE: • For peripheral settings, refer to "5: "Host Settings" and "6: Printer Settings" which carry description of similar settings. How to Set Peripheral Connection (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears. *SELECT* 1:Stored Data 2:Quality Control 3:Calibration 4:Replace Lyse 5:Auto Rinse 6:Settings 7:Maintenance 8:Periph. Settings 00:PU Sleep Figure 10-11-1: Select Menu Screen (2) Using [ ] or [ ] key, move the cursor to select "8: Periph. Settings." (3) Press [ENTER] key. This displays connection status of external devices on the Peripheral Settings screen. *Periph.Settings* DP Use Host Output Use ID Reader Use Press [SELECT] to exit. IP Use GP/ LP Use (Data Printer) (Graphic Printer) (Built-in Printer) Figure 10-11-2: Peripheral Settings Screen Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 322. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-37 (4) Using [ ] or [ ] key, move the cursor to select the desired external device. (5) Using [ ] or [ ] key, select "Use" or "Not Use". "Use" and "Not Use" change over each time you press the key. (6) Press [ENTER] key. The content of the settings is set and moves the cursor to the next set parameter. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. (7) Press [SELECT] key. The Setting Change Confirmation message appears. Change? Cont. Set Cancel Figure 10-11-3: Setting Change Confirmation Message (8) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel." [Cont.]: Returns to the Peripheral Settings screen. And the setting operation can be continued. [Set]: Updates the settings and returns to the Analysis screen. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (9) Press [ENTER] key to execute the selected process.
  • 323. INSTRUMENT SETUP 10-38 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. 12. FACTORY SETTINGS The settings made at the factory are listed below: • System Settings Units Type 2 Language English Parameter Naming LYM% • Date/Time Date Format dd/mm/yyyy • Patient Limits LL UL WBC 3.0 15.0 RBC 2.50 5.50 HGB 8.0 17.0 HCT 26.0 50.0 MCV 86.0 110.0 MCH 26.0 38.0 MCHC 31.0 37.0 PLT 50 400 LYM% 5.0 55.0 MXD% 1.0 20.0 NEUT% 45.0 95.0 LYM# 0.0 0.0 MXD# 0.0 0.0 NEUT# 0.0 0.0 RDW-SD 37.0 54.0 RDW-CV 11.0 16.0 MPV 9.0 13.0 • QC Settings QC Method L-J Data Output Print • Host Settings Connect Not use Output format KX-21N Auto Output Off Baud Rate 2400 bps Data Length 7 bits Stop Bit 2 bits Parity Check Even Protocol Class A Interval 2 RTS/CTS Ignore RDW Output RDW-CV ID Padding 0 Padding Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.
  • 324. INSTRUMENT SETUP Sysmex KX-21N Operator’s Manual -- October 1999 10-39 • Printer Settings (DP) Connect Not use DP Auto Output Off • Printer Settings (GP/LP) Connect Not use Printer type Type 1 GP Auto Output Off • Printer Settings (IP) Connect Use Print Condition All Data Print Format Type 1 • ID Reader Connect Not Use
  • 325. Sysmex KX-21N Operator’s Manual -- Revised February 2000 INSTALLATION APPENDIX A: INSTALLATION 1. INTRODUCTION ........................................................................A-1 2. CHECK BEFORE INSTALLATION ..................................................A-2 3. INSTALLATION SPACE ...............................................................A-3 4. REMOVE SHIPPING CLAMPS .......................................................A-4 5. CONNECT TUBE ........................................................................A-6 5.1 Prepare Reagent ....................................................................A-6 5.2 Connect CELLPACK..............................................................A-6 5.3 Connect STROMATOLYSER-WH..............................................A-8 5.4 Connect Waste Line................................................................A-9 6. SET PRINTER PAPER ................................................................ A-10 7. CONNECT POWER CORD AND CONNECTING CABLES.................... A-12 7.1 Connect Host Computer, Printer, and Hand Held Barcode Reader........ A-12 7.2 Connect Power Cord ............................................................ A-12 8. TURN POWER ON .................................................................... A-13 9. REINSTALLING THE PROGRAM ................................................. A-13
  • 326. INSTALLATION Sysmex KX-21N Operator’s Manual -- October 1999 A-1 1 . INTRODUCTION This product is a clinical test instrument. Sysmex representative is responsible for unpacking, installing, and initial setup of the product to ensure its proper and safe operation. The next several pages will give some essential information on this instrument. NOTE: • When the optional external printers (Data Printer and Graphic Printer) or Hand Held Barcode Reader is intended to incorporate to this instrument, contact your Sysmex service representative. Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 327. INSTALLATION A-2 Sysmex KX-21N Operator’s Manual -- October 1999 2 . CHECK BEFORE INSTALLATION Make sure the KX-21N is free from external damages and check the quantities of the provided supply parts. Quantity No. Part No. Description 117 V 220 V 240 V 1 1 2 2 2 3 4 5 6 7 8 9 10 10 11 12 13 14 461-2264-1 461-2265-5 923-8092-8 265-4731-5 265-4728-3 943-1781-1 973-3041-7 367-1051-9 442-5338-7 442-5340-5 423-1776-2 933-3601-9 266-5109-1 266-5292-6 266-6743-4 369-8234-6 462-4842-7 993-2811-6 OPERATOR'S MANUAL KX-21N (N.A.) OPERATOR'S MANUAL KX-21N (ENGLISH) POWER CORD NO. 15 (C-2/N. AMERICA) POWER CORD 4622-007-0092 (EUROPE) POWER CORD NO. 7650 CUBITAINER SPOUT KIT NO. 1 (20 L) FLOAT SWITCH NO. 23 ASSY TRAY NO. 20 TUBE POLYURETHANE 4 MM ID × 6 MM OD TUBE POLYURETHANE 6 MM ID × 9 MM OD MINI-PET NO. 10 (1 ML) TRANSDUCER BRUSH NO. 1 FUSE 250V 3.15A ST4-3.15A-N1 FUSE 250V 2A NO. 19195 (EUROPE) CLAMP LWS-8S-2.5W CAUTION MARK NO.170 PAPER THERMAL F1-2 (5/BOX) PROGRAM CARD 1KXNH ASSY 1 0 1 - - 1 1 1 3 M 6 M 2 1 2 - 1 1 1 1 0 1 - 1 - 1 1 1 3 M 6 M 2 1 - 2 1 1 1 1 0 1 - - 1 1 1 1 3 M 6 M 2 1 - 2 1 1 1 1 Table A-2-1: KX-21N Unpacking Checklist NOTE: • Item No. 4 (973-3041-7 Float Switch No. 23 Assy) is pre-installed in the Main Unit Front Interior at the factory. • Affix the Caution Mark No.170 to some place on the front panel that is easily visible. • If you need to order supplies or replacement parts, please contact your local Sysmex representative. Sysmex KX-21N Operator’s Manual -- Revised August 2001
  • 328. INSTALLATION Sysmex KX-21N Operator’s Manual -- October 1999 A-3 3 . INSTALLATION SPACE To ensure that the instrument performs to its full extent, it should be installed at an appropriate place. • Select a place where the power supply is located close. • Secure a space for maintenance and service. Giving consideration to heat radiation by the instrument, provide at least 50 cm clearance between the wall and the instrument's side rear, and top panels. You may need some more desktop space if optional Data Printer and Graphic Printer are provided. Each dimension of the instrument is shown below. The power cord is 1.8 m long. Width (mm) Depth (mm) Height (mm) Weight (kg) Main Unit 420 355 480 30 Table A-3-1: Instrument Dimensions 480 355 420 Figure A-3-1: Instrument Dimensions
  • 329. INSTALLATION A-4 Sysmex KX-21N Operator’s Manual -- Revised May 2002 N.A. 4 . REMOVE SHIPPING CLAMPS (1) Peel off the fixing tape of the outer cover gently. Figure A-4-1: Removing the Tape (2) Open the front cover of the main unit. (3) Remove the protection sheets of the sampling valve. 1) Remove the SRV fixing screw. 2) With the fixed and rotary valves separated sufficiently, remove the protection sheets. 3) Return the valves and the SRV fixing screw to their original positions. 4) Set the provided sample rotor valve tray. Protection Sheets SRV Fixing Screw Tray No. 20 Figure A-4-2: Removing the Protection Sheets
  • 330. INSTALLATION Sysmex KX-21N Operator’s Manual -- October 1999 A-5 (4) Remove the pneumatic unit fixing screws (2 pcs). Keep these screws for future use. Fixing Screws Figure A-4-3: Removing the Screws (5) Remove the rubber caps of the reagent connection nipples. Keep these rubber caps for future use. Rubber Caps Figure A-4-4: Removing the Rubber Caps Sysmex KX-21N Operator’s Manual -- Revised May 2003
  • 331. INSTALLATION A-6 Sysmex KX-21N Operator’s Manual -- October 1999 5 . CONNECT TUBE 5.1 Prepare Reagent Prepare the reagents and connection kits shown below. Reagent Part No. Type Part Name Connection Kit 884-0871-1 PK-30L CELLPACK Cubitainer spout kit No. 1 (for 20L) 974-0521-6 SWH-200A STROMATOLYSER-WH Float switch No. 23 5.2 Connect CELLPACK (1) Prepare the following reagent tube. Tube Polyurethane 4 mmID × 6 mmOD : 1 pc NOTE: • Cut the tube to an appropriate length, and connect it. (2) Connect the diluent (CELLPACK) inlet aspiration nipple behind the unit and the nipple of the cubitainer spout kit No. 1 with the tube polyurethane 4 mmID × 6 mmOD. (3) Set the cubitainer spout kit No. 1 to the CELLPACK container. CELLPACK Cap Cubitainer Spout Kit No. 1 Figure A-5-1: Setting the Cubitainer Spout Kit
  • 332. INSTALLATION Sysmex KX-21N Operator’s Manual -- October 1999 A-7 Tube Polyurethane 4 mmID × 6 mmOD Diluent Inlet Nipple Cubitainer Spout Kit No. 1 CELLPACK Figure A-5-2: Connecting the CELLPACK • Take care not to spill a reagent on to the instrument. If it spills, wipe it off immediately using a wet cloth or the like. • If it happens to adhere to your skin, wash it off using plenty of water. • If a reagent happens to enter your eye, wash it off immediately using plenty of water, and take medical treatment at once. • After unpacking, be sure not to allow dust or dirt to come into the instrument. Use up CELLPACK within 60 days from the unpacking date, and STROMATOLYSER-WH within 90 days. CAUTION: • When the diluent (CELLPACK) tube is more than 2 m long, it may be impossible to have reagent aspirated. Avoid setting CELLPACK at a level higher than the instrument; otherwise, reagent may flow into the vacuum line, possibly damaging the instrument. CAUTION: • After connecting the tube, do not pull it by force for reagent replacement. CAUTION Sysmex KX-21N Operator’s Manual -- Revised May 2003
  • 333. INSTALLATION A-8 Sysmex KX-21N Operator’s Manual -- October 1999 5.3 Connect STROMATOLYSER-WH (1) Gently remove the provided float switch No. 23 from the dust-protection bag. (2) Install the float switch No. 23 to STROMATOLYSER-WH. Then, set it to the table. STROMATOLYSER-WH Float switch No. 23 Figure A-5-3: Installing the STROMATOLYSER-WH
  • 334. INSTALLATION Sysmex KX-21N Operator’s Manual -- October 1999 A-9 5.4 Connect Waste Line (1) Prepare the following waste line tube. Tube Polyurethane 6 mmID × 9 mmOD : 1 pc (2) Connect an end of the tube polyurethane 6 mmID × 9 mmOD to the drain outlet nipple behind the unit. Connect the other end of the tube to the waste sewer in the lab. If the waste sewer is not available, connect it to a waste tank. The maximum waste line length is 6 m. NOTE: • Cut the tube to an appropriate length, and connect it. • Since waste is removed from the system by pressurized air, the waste tank may be located at the same height as, or lower than, the drain outlet nipple. Otherwise the waste may be flown back into the system, which will result of a malfunction. (3) Arrange and tie the diluent and waste line tubings as shown in the figure using the provided clamp. Drain Outlet Nipple Tube Polyurethane 6 mmID × 9 mmOD Waste Sewer or Waste Tank Clamp Diluent Inlet Nipple Figure A-5-4: Connecting the Waste Line and Clamping Tubings Sysmex KX-21N Operator’s Manual -- Revised May 2003
  • 335. INSTALLATION A-10 Sysmex KX-21N Operator’s Manual -- October 1999 6 . SET PRINTER PAPER (1) Open the front cover of the main unit. (2) Turn the release lever up to free the paper. Release Lever Figure A-6-1: Releasing the Lever (3) Mount a printer paper. Printer Paper Figure A-6-2: Mounting a Printer Paper Sysmex KX-21N Operator’s Manual -- Revised February 2000
  • 336. INSTALLATION Sysmex KX-21N Operator’s Manual -- October 1999 A-11 (4) Pass the printer paper as shown below, and turn the release lever down to secure. Figure A-6-3: Securing the Release Lever (5) Cut off any printer paper extending from the upper part of the printer. Figure A-6-4: Cutting Off Paper (6) Close the front cover of the main unit.
  • 337. INSTALLATION A-12 Sysmex KX-21N Operator’s Manual -- October 1999 7 . CONNECT POWER CORD AND CONNECTING CABLES 7.1 Connect Host Computer, Printer, and Hand Held Barcode Reader Connect to each instrument with connecting cables. ID Reader Connector GP Connector DP Connector Serial Interface Figure A-7-1: Connecting the Connecting Cables NOTE: • Perform setting concerning the output referring to Chapter 10, Section 6: HOST SETTINGS, Chapter 10, Section 7: PRINTER SETTINGS or Chapter 10, Section 8: ID READER SETTINGS to use the connected external instruments. 7.2 Connect Power Cord Connect the provided power cord to the power supply outlet. Connect to the Power Supply Outlet Power Cord Figure A-7-2: Connecting the Power Cord Sysmex KX-21N Operator’s Manual -- Revised May 2003
  • 338. INSTALLATION Sysmex KX-21N Operator’s Manual -- October 1999 A-13 8 . TURN POWER ON It is necessary to run the service sequence at the initial start-up. Your Sysmex service representative is responsible for the operation. 9 . REINSTALLING THE PROGRAM The program is installed in the KX-21N in the factory, but when there is a necessity for reinstalling the program by a problem or any other reason, reinstall the program according to the following procedures. (1) Turn OFF the power of the main unit. (2) Loosen the screws of the card slot protective cover on the rear panel, and open the card slot protective cover. (3) Insert the program card in the card slot. Figure A-8-1: Insert the Program Card (4) Close the card slot protective cover, and turn ON the power. (5) When "*Program Upgrade*" is displayed on the screen, press [1] key, and then install the program. When the installation is completed, the message "Installation was successful" will be displayed. (6) Turn OFF the power, and extract the program card. (7) Close the card slot protective cover, and turn ON the power. Sysmex KX-21N Operator’s Manual -- Revised May 2003
  • 339. Sysmex KX-21N Operator’s Manual -- October 1999 TECHNICAL INFORMATION APPENDIX B: TECHNICAL INFORMATION 1. OUTPUT FORMAT FOR HOST COMPUTER ......................................B-1 1.1 HARDWARE.......................................................................B-1 1.2 SOFTWARE........................................................................B-3 2. HAND HELD BAR CODE READER SPECIFICATIONS........................ B-15 Sysmex KX-21N Operator’s Manual -- Revised June 2001
  • 340. TECHNICAL INFORMATION Sysmex KX-21N Operator’s Manual -- October 1999 B-1 1 . OUTPUT FORMAT FOR HOST COMPUTER The bit serial voltage type, which conforms to the RS-232C interface, is used for host computer output of the KX-21N. The serial interface port for the connection with the host computer is on the rear panel of the main unit. 1.1 Hardware 1 . Connector • The connector for the output to the host computer is located on the rear panel. • Use a 9-pin D-SUB, female connector. • Fixing screws for this connector are in inch-specification. 2 . Connector Signals Pin No. Signal Name Signal Direction 1 2 Receive data (R×D) From Host to KX-21N 3 Transmit Data (T×D) To Host from KX-21N 4 Data Terminal Ready (DTR) To Host from KX-21N 5 Signal Ground (SG) 6 Data Set Ready (DSR) From Host to KX-21N 7 Request to Send (RTS) To Host from KX-21N 8 Clear to Send (CTS) From Host to KX-21N 9 Table B-1-1: Pin Assignment 3 . Communication Format The data is communicated in the asynchronous, full duplex mode. 4 . Signal Level Signal level conforms to JIS C6361. Level Data signal Control signal +3V or higher Logic "1", Start bit ON -3V or lower Logic "0", Stop bit OFF Table B-1-2: Signal Level Sysmex KX-21N Operator’s Manual -- Revised June 2001
  • 341. TECHNICAL INFORMATION B-2 Sysmex KX-21N Operator’s Manual -- October 1999 5 . Interface Circuit • Output circuit 300 Ω OUT EMI filter MC145407 Driver Vss VDD Figure B-1-1: Interface Output Circuit • Input circuit IN EMI filter 5.4 kΩ MC145407 Receiver 15 kΩ VDD Vss Figure B-1-2: Interface Input Circuit
  • 342. TECHNICAL INFORMATION Sysmex KX-21N Operator’s Manual -- October 1999 B-3 1.2 Software 1 . Communication Format 1 ) Code ASCII codes are used for output. (Except for K-DPS output) 2 ) Structure of text "STX" (02 H) is sent prior to data and "ETX" (03 H) is sent at the end of data. (Except for K-DPS output) S T X E T X Order of transmission Figure B-1-3: Order of Transmission 3 ) Communication protocol The following 2 protocols are provided in the system, and can be selected according to the system status. • Class A One-way transmission to the host computer without requiring ACK nor NAK from host computer. • Class B The KX-21N transmits data and then waits for ACK or NAK to complete the data transmission. Analysis data is sent. Analysis data transmission is completed correctly. Communication error occurs. Analysis data is sent automatically (retrying up to 3 times). If the reply is still NAK after 3 retries, instruction is made whether the same data is sent again or the transmission is canceled by key input. Analysis data is received. When an error does not occur, ACK (06H) is sent. When an error occurs, NAK (15H) is sent. KX-21N Host computer ACK NAK Figure B-1-4: Data Transmission
  • 343. TECHNICAL INFORMATION B-4 Sysmex KX-21N Operator’s Manual -- October 1999 4 ) Transmission errors If the KX-21N detects a transmission error, the data transmission is canceled and an error message is displayed. Re-transmission of the data ([1] key) or cancellation of the transmission ([3] key) can be selected. Transmission errors occur in the following situations. • The computer is off line. • The control signal DSR is off. • After the data is transmitted, there is no response from the computer in 15 seconds. (Class B only) • After the data is transmitted, other than ACK or NAK is sent from the computer. (Class B only) • After the data is transmitted, the fourth NAK is sent. (Class B only. The KX-21N resends the data automatically up to 3 times when NAK is sent.) 5 ) Timing, subject, and content of transmission Serial interface ↓ Host computer Normal analysis Analysis data (A) Quality control QC data (A) Table B-1-3: Content of Transmission • Analysis data includes the date, sample ID No., parameter data, and the flag. • QC data is X or L-J data. • The setting of the connecting device is changed in the setting program. 2 . Text Format The following three types of formats are used for computer output. • KX-21N: Format for connecting to the host computer • K-1000: Format for connecting to the host computer • K-DPS: Special format for connecting to K-DPS NOTE: • KX-21N format is selected at the time of shipping from the factory. The details of KX-21N and K-1000 format are as follows. • KX-21N format KX-21N format has two formats; one is "analysis data format" for output of the sample data, and the other is "QC data format" for output of the QC data. They differ in length and content of the text. (They are distinguished by the sample distinction code.) The text distinction code II is fixed at "1". However, when the text exceeds 256 bytes in a future modification, the text is divided into 2 or more blocks. The number in text distinction code II shows the order of the blocks. The ETB (17 H) is not used. Sysmex KX-21N Operator’s Manual -- Revised June 2001
  • 344. TECHNICAL INFORMATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. B-5 (1) Analysis data format Parameter No. of Characters Example STX 1 (02 H) Text distinction code I 1 "D" Text distinction code ll 1 "1" Sample distinction code 1 "U" Year 4 "1999" Month 2 "09" Day 2 "30" Analysis information 1 (O) Sample ID No. 15 (OOOOOOOOOOOOOOO) PDA information 6 (OOOOOO) Reserve 1 "O" WBC [×103 /µL] 5 XXX.XF RBC [×106 /µL] 5 XX.XXF HGB [g/dL] 5 XXX.XF HCT [%] 5 XXX.XF MCV [fL] 5 XXX.XF MCH [pg] 5 XXX.XF MCHC [g/dL] 5 XXX.XF PLT [×103 /µL] 5 XXXXF LYM% (W-SCR) [%] 5 XXX.XF MXD% (W-MCR) [%] 5 XXX.XF NEUT% (W-LCR) [%] 5 XXX.XF LYM# (W-SCC) [×103 /µL] 5 XXX.XF MXD# (W-MCC) [×103 /µL] 5 XXX.XF NEUT# (W-LCC) [×103 /µL] 5 XXX.XF RDW-SD [fL] 5 XXX.XF RDW-CV [%] 5 XXX.XF (Dummy) 5 XXX.XF MPV [fL] 5 XXX.XF (Dummy) 5 XXX.XF ETX 1 (03 H) Total 131 Table B-1-4: Analysis Data Format Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
  • 345. TECHNICAL INFORMATION B-6 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. (2) QC data format Parameter No. of Characters Example STX 1 (02 H) Text distinction code I 1 "D" Text distinction code II 1 "1" Sample distinction code 1 "C" Data distinction code 1 "X" or "L" Year 4 "1999" Month 2 "09" Day 2 "30" Hour 2 "09" Minute 2 "59" QC File Number 1 "5" Not used 1 "0" Reserve 1 "0" WBC [×103 /µL] 4 XXX.X LYM% (W-SCR) [%] 4 XXX.X MXD% (W-MCR) [%] 4 XXX.X NEUT% (W-LCR) [%] 4 XXX.X LYM# (W-SCC) [×103 /µL] 4 XXX.X MXD# (W-MCC) [×103 /µL] 4 XXX.X NEUT# (W-LCC) [×103 /µL] 4 XXX.X RBC [×106 /µL] 4 XX.XX HGB [g/dL] 4 XXX.X HCT [%] 4 XXX.X MCV [fL] 4 XXX.X MCH [pg] 4 XXX.X MCHC [g/dL] 4 XXX.X RDW- SD [fL] 4 XXX.X RDW- CV [%] 4 XXX.X PLT [×103 /µL] 4 XXXX (Dummy) 4 XXX.X MPV [fL] 4 XXX.X (Dummy) 4 XXX.X W-SMV [fL] 4 XXX.X W-LMV [fL] 4 XXX.X ETX 1 (03 H) Total 105 Table B-1-5: QC data format Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
  • 346. TECHNICAL INFORMATION Sysmex KX-21N Operator’s Manual -- October 1999 B-7 (3) Details of the analysis data output in KX-21N format 1) The order of output is from the top parameter to the bottom. The data is sent from the upper line without performing zero suppression. 2) Because the decimal point is not sent, the decimal point specified in each parameter has to be added and represented by numeric value at the host computer. 3) Analysis information shows the following content of the analysis. Manual No. input WB mode analysis "0" Pre-diluted mode analysis "5" Table B-1-6: Analysis Information 4) PDA information consists of the following 6 items. Item No. of Characters WBC histogram information 1 WBC histogram flag 1 RBC histogram information 1 RBC histogram flag 1 PLT histogram information 1 PLT histogram flag 1 Table B-1-7: PDA Information Code Description "0" Histogram is normal. "1" Histogram is abnormal. "2" Manually discriminated Table B-1-8: Histogram Information Sysmex KX-21N Operator’s Manual -- Revised June 2001
  • 347. TECHNICAL INFORMATION B-8 Sysmex KX-21N Operator’s Manual -- October 1999 Code Description "0" Normal WBC/RBC/PLT "1" (L) discriminator degree is high. WBC/RBC/PLT "2" (U) discriminator degree is high. WBC/RBC/PLT "3" Analysis is impossible because there is no pair of intersection on the 20% degree level for calculation of DW. RBC/PLT "4" Two peaks are recognized in the particle distribution. RBC/PLT "5" (T1) discriminator cannot be determined. WBC "6" (T2) discriminator cannot be determined. WBC "7" (T1) discriminator level is high, and the data is not reliable. WBC "8" (T1) or (T2) discriminator level is high, and the data is not reliable. WBC "9" (T2) discriminator level is high, and the data is not reliable. WBC "A" The particle count equal to or less than (L) discriminator exceeds the range. WBC Table B-1-9: Histogram Flag The histogram flag corresponds to the flagging characters of the LCD and the printer as follows. Particle distribution Flagging characters of LCD and printer FLAG WBC RBC PLT “0” “1” WL RL PL “2” WU RU PU “3” DW DW “4” MP MP “5” T1 “6” T2 “7” F1 “8” F2 “9” F3 "A" AG Table B-1-10: Flagging Character Sysmex KX-21N Operator’s Manual -- Revised June 2002
  • 348. TECHNICAL INFORMATION Sysmex KX-21N Operator’s Manual -- October 1999 B-9 5) The numerical data configuration in the Analysis Data Format is as follows. Upper digit Lower digit Data Flag Figure B-1-5: Numerical Data Configuration Code Description "0" Normal "1" Abnormality judgment is "+." "2" Abnormality judgment is "-." "3" Out of linearity limit "4" Reliability is low. Table B-1-11: Details of Flag 6) In case of analysis error, or if the data lacks some data such as the calculation parameter in pre-diluted mode, the data is transmitted as follows: *0000 • K-1000 format K-1000 format has two formats; one is "analysis data format" for output of the sample data, and the other is "QC data format" for output of the QC data. They differ in length and content of the text. (They are distinguished by the sample distinction code.) The text distinction code II is fixed at "1". However, when the text exceeds 256 bytes in a future modification, the text is divided into 2 or more blocks. The number in text distinction code II shows the order of the blocks. The ETB (17 H) is not used. Sysmex KX-21N Operator’s Manual -- Revised June 2002
  • 349. TECHNICAL INFORMATION B-10 Sysmex KX-21N Operator’s Manual -- October 1999 N.A. (1) Analysis data format Parameter No. of Characters Example STX 1 (02 H) Text distinction code I 1 "D" Text distinction code ll 1 "1" Sample distinction code 1 "U" Year 2 "99" Month 2 "09" Day 2 "30" Analysis information 1 (O) Sample ID No. 12 (OOOOOOOOOOOO) PDA information 6 (OOOOOO) RDW select information 1 "S" or "C" WBC [×103 /µL] 5 XXX.XF RBC [×106 /µL] 5 XX.XXF HGB [g/dL] 5 XXX.XF HCT [%] 5 XXX.XF MCV [fL] 5 XXX.XF MCH [pg] 5 XXX.XF MCHC [g/dL] 5 XXX.XF PLT [×103 /µL] 5 XXXXF LYM% (W-SCR) [%] 5 XXX.XF MXD% (W-MCR) [%] 5 XXX.XF NEUT% (W-LCR) [%] 5 XXX.XF LYM# (W-SCC) [×103 /µL] 5 XXX.XF MXD# (W-MCC) [×103 /µL] 5 XXX.XF NEUT# (W-LCC) [×103 /µL] 5 XXX.XF RDW-SD/CV [fL/%] 5 XXX.XF (Dummy) 5 XXX.XF MPV [fL] 5 XXX.XF (Dummy) 5 XXX.XF ETX 1 (03 H) Total 121 Table B-1-12: Analysis Data Format Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
  • 350. TECHNICAL INFORMATION Sysmex KX-21N Operator’s Manual -- October 1999 N.A. B-11 (2) QC data format Parameter No. of Characters Example STX 1 (02 H) Text distinction code I 1 "D" Text distinction code II 1 "1" Sample distinction code 1 "C" Data distinction code 1 "X" or "L" Year 2 "97" Month 2 "09" Day 2 "30" Hour 2 "09" Minute 2 "59" QC File Number 1 "5" Not used 1 "0" RDW select information 1 "C" WBC [×103 /µL] 4 XXX.X LYM% (W-SCR) [%] 4 XXX.X MXD% (W-MCR) [%] 4 XXX.X NEUT% (W-LCR) [%] 4 XXX.X LYM# (W-SCC) [×103 /µL] 4 XXX.X MXD# (W-MCC) [×103 /µL] 4 XXX.X NEUT# (W-LCC) [×103 /µL] 4 XXX.X RBC [×106 /µL] 4 XX.XX HGB [g/dL] 4 XXX.X HCT [%] 4 XXX.X MCV [fL] 4 XXX.X MCH [pg] 4 XXX.X MCHC [g/dL] 4 XXX.X RDW-(CV/SD) [%/fL] 4 XXX.X PLT [×103 /µL] 4 XXXX (Dummy) 4 XXX.X MPV [fL] 4 XXX.X (Dummy) 4 XXX.X W-SMV [fL] 4 XXX.X W-LMV [fL] 4 XXX.X ETX 1 (03 H) Total 99 Table B-1-13: QC data format Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
  • 351. TECHNICAL INFORMATION B-12 Sysmex KX-21N Operator’s Manual -- October 1999 (3) Details of the analysis data output in K-1000 format 1) The order of output is from the top parameter to the bottom. The data is sent from the upper line without performing zero suppression. 2) Because the decimal point is not sent, the decimal point specified in each parameter has to be added and represented by numeric value at the host computer. 3) Analysis information shows the following content of the analysis. Manual No. input WB mode analysis "0" Pre-diluted mode analysis "5" Table B-1-14 Analysis Information 4) The sample ID No. is 15-digit numerals, but 12 digits are output in this format. The upper 3 digits are deleted. Depending on the usage, "-" (2D H) may be inserted in the numeral column. In this case, "-" is included in the 12 digits. 5) PDA information consists of the following 6 items. Item No. of Characters WBC histogram information 1 WBC histogram flag 1 RBC histogram information 1 RBC histogram flag 1 PLT histogram information 1 PLT histogram flag 1 Table B-1-15: PDA Information Code Description "0" Histogram is normal. "1" Histogram is abnormal. "2" Manually discriminated Table B-1-16: Histogram Information Sysmex KX-21N Operator’s Manual -- Revised June 2001
  • 352. TECHNICAL INFORMATION Sysmex KX-21N Operator’s Manual -- October 1999 B-13 Code Description "0" Normal WBC/RBC/PLT "1" (L) discriminator degree is high. WBC/RBC/PLT "2" (U) discriminator degree is high. WBC/RBC/PLT "3" Analysis is impossible because there is no pair of intersection on the 20% degree level for calculation of DW. RBC/PLT "4" Two peaks are recognized in the particle distribution. RBC/PLT "5" (T1) discriminator cannot be determined. WBC "6" (T2) discriminator cannot be determined. WBC "7" (T1) discriminator level is high, and the data is not reliable. WBC "8" (T1) or (T2) discriminator level is high, and the data is not reliable. WBC "9" (T2) discriminator level is high, and the data is not reliable. WBC "A" The particle count equal to or less than (L) discriminator exceeds the range. WBC Table B-1-17: Histogram Flag The histogram flag corresponds to the flagging characters of the LCD and the printer as follows. Particle distribution Flagging characters of LCD and printer FLAG WBC RBC PLT “0” “1” WL RL PL “2” WU RU PU “3” DW DW “4” MP MP “5” T1 “6” T2 “7” F1 “8” F2 “9” F3 "A" AG Table B-1-18: Flagging Character Sysmex KX-21N Operator’s Manual -- Revised June 2002
  • 353. TECHNICAL INFORMATION B-14 Sysmex KX-21N Operator’s Manual -- October 1999 6) RDW select information It shows whether RDW-CV or RDW-SD is output. "C": RDW-CV "S": RDW-SD NOTE: • RDW-SD is selected at the initial setting of K-1000. • To output RDW-CV, refer to Chapter 10, Section 6: HOST SETTINGS. 7) The numerical data configuration in the Analysis Data Format is as follows. Upper digit Lower digit Data Flag Figure B-1-6: Numerical Data Configuration Code Description "0" Normal "1" Abnormality judgment is "+." "2" Abnormality judgment is "-." "3" Out of linearity limit "4" Reliability is low. Table B-1-19: Details of Flag 8) In case of analysis error, or if the data lacks some data such as the calculation parameter in pre-diluted mode, the data is transmitted as follows: *0000 Sysmex KX-21N Operator’s Manual -- Revised June 2002
  • 354. TECHNICAL INFORMATION Sysmex KX-21N Operator’s Manual -- October 1999 B-15 2. HAND HELD BAR CODE READER SPECIFICATIONS 1. Hardware Specifications 1) Specification (1) The kind of Bar Code: UPC-A, UPC-E, CODE39, CODE128, ITF, NW-7 (2) Decoder: Built-in a reading head. (3) Interface: RS-232C (4) Connector: DIN 8P (5) Power Supply: DC5V+/-5% 2) Pin Arrangement of Connector (DIN 8P) Pin No. Signal name Direction of signal 1 TXD Transmitting Data to HOST 2 RXD Receiving Data from HOST 3 RTS Request to Send to HOST 4 CTS Clear to Send from HOST 5 NC 6 DTR Data Terminal ready to HOST 7 SG Signal Ground 8 +5V from HOST 3) Data Transmission Procedure PRE (ID) DATA POST PRE: STX POST: ETX 2. Software Specifications 1) Communication Protocol Baud Rate 2400 Code 7-bit Stop Bit 2-bit Parity Even RTS/CTS Use Protocol None Preamble Transmit STX Postamble Transmit ETX Sysmex KX-21N Operator’s Manual -- Revised November 2000
  • 355. TECHNICAL INFORMATION B-16 Sysmex KX-21N Operator’s Manual -- October 1999 2) Protocol RTS/CTS Effective Non Protocol 3) Format STX DATA ETX 4) The Kind of Bar Code (1) CODE39 Data can be transmitted without Check Digits, since Check Digits (MOD-43) is judged within Bar Code Reader. All data may be transmitted with Check Digits, but with no-effect. (2) JAN, UPC-A, UPC-E, EAN13, EAN8 Data can be transmitted without Check Digits, since Check Digits (MOD-10) is judged within Bar Code Reader. (3) NW-7 Data can be transmitted without Check Digits, since Check Digits (MOD-16) is judged within Bar Code Reader. All data except Start/Stop Code may be transmitted by the setup of the Check Digits, but with no-effect. (4) ITF Data can be transmitted without Check Digits, since Check Digits (MOD-10) is judged within Bar Code Reader. All data may be transmitted with Check Digits, but with no-effect. (5) CODE128 Data can be transmitted without Check Digits, since Check Digits (MOD-103) is judged within Bar Code Reader. 3. Setting for Each Bar Code Symbology Set the optional manual ID Bar Code Reader, as specified for each bar code symbology. 1) Code39 Check Digit=Use Check Digit=Not transmit ST/SP=Not transmit Full ASCII=Non Multi-read=No ID Character=Not transmit Sysmex KX-21N Operator’s Manual -- Revised November 2000
  • 356. TECHNICAL INFORMATION Sysmex KX-21N Operator’s Manual -- October 1999 B-17 2) NW-7 Check Digit=Not transmit ST/SP=Not transmit ST/SP Character=a, b, c, d Hex Format=No ID Character=Not transmit 3) UPC-A, UPC-E, EAN13, EAN8 Check Digit=Not transmit Add-On=No ID Character=Not transmit 4) ITF Check Digit=Not transmit ID Character=Not transmit 5) Code128 Check Digit=Use Check Digit=Not transmit ID Character=Not transmit Sysmex KX-21N Operator’s Manual -- Revised November 2000
  • 357. Sysmex KX-21N Operator’s Manual -- October 1999 N.A. i INDEX A Adjusting Pressure to 0.05 MPa --------------8-5 Adjusting Vacuum to 0.0333 MPa-----------8-6 Adjustment of Pressure and Vacuum --------8-2 Alarm Sounds -------------------------------- 1-13 Alphabetical List of Error Messages Displayed on Analysis Screen ---------7-3 Alphabetical List of Error Messages Displayed on HELP Screen ------------7-4 Analysis Errors------------------------------- 7-17 Analysis of Histogram----------------------- 9-11 Analysis of RBC/PLT Histogram ----------- 9-20 Analysis of WBC Histogram ---------------- 9-11 Analysis Parameters----------------------------1-5 Analysis Procedure Flow Chart --------------2-2 As-Needed Maintenance and Procedure--- 4-24 Auto Rinse------------------------------------ 4-24 Automatic Calibration -------------------------6-5 Automatic Calibration Procedure-------------6-6 Automatic Stop Function of Pneumatic Unit1-4 B Blood Cell Discrimination Circuit ---------- 9-10 C Calculating Calibration Value--------------- 6-11 Calculation of RBC Constant -----------------9-9 Calibration--------------------------------------6-1 Calibration Flow Chart ------------------------6-4 Calibration History Print -------------------- 6-25 Calibrator Calibration-------------------6-3, 6-15 Calibrator Calibration Procedure ----------- 6-17 Calibrator Calibration Program---------------6-1 CBC Analysis-----------------------------------9-5 Cell Count Parameters ----------------------- 2-28 Chamber Errors ------------------------------ 7-10 Check before Installation--------------------- A-2 Check Trap Chamber Level and Discard ----4-6 Clean Rinse Cup------------------------------ 4-26 Clean Sample Rotor Valve (SRV) ---------- 4-16 Clean SRV Tray--------------------------------4-7 Clean TD Chamber and Diluted Sample Line (Shutdown) ------------------------4-4 Clean Transducer (Rinse Sequence)-------- 4-12 Clean Waste Chamber (Rinse Sequence)-----4-9 Clean WBC/RBC Transducer Aperture ----- 4-28 Confirmation of Cycle Number ------------ 4-41 Connect Cables-------------------------------A-12 Connect CELLPACK ------------------------- A-6 Connect Host Computer---------------------A-12 Connect Hand Held Barcode Reader-------A-12 Connect Power Cord-------------------------A-12 Connect Printer-------------------------------A-12 Connect STROMATOLYSER-WH ---------- A-8 Connect Tube --------------------------------- A-6 Connect Waste Line--------------------------- A-9 Contents of Display----------------------------1-8 Connects of Package------------------------- 1-13 Correcting a Sample Number--------------- 3-23 D Daily Maintenance and Procedure -----------4-4 Date/Time Settings --------------------------- 10-8 DC Detection Method -------------------------9-2 Deletion--------------------------------------- 5-27 Deletion (Stored Data)----------------------- 3-20 Detection Principle-----------------------------9-2 Display and Printing of Analysis Result --- 2-24 Display of Analysis Result -------------2-24, 3-2 DP Output Settings--------------------------10-23 E Electric System------------------------------- 9-28 Emergency Stop Procedure----------------- 1-12 Erase All ----------------------------------------5-7 Error History Print -------------------------- 7-36 Every 3-Month Maintenance and Procedure ----------------------------- 4-16 Execute X Control--------------------------- 5-10 Execute L-J Control ------------------------- 5-19 Execute QC Program --------------------------5-5 Executing and Quitting Stored Data Processing Program------------------- 3-14 Executing Automatic Calibration Program- 6-5 Executing Calibrator Calibration Program 6-15 Execution of Shutdown --------------------- 2-32 Exit from QC Control Program------------- 5-26 Expected Results ----------------------------- 2-30 External Device Errors ---------------------- 7-33 External Output ----------------- 3-11,3-21,5-31 Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.
  • 358. ii Sysmex KX-21N Operator’s Manual -- October 1999 N.A. F Factory Setting ------------------------------10-38 Front Interior--------------------------------- 9-31 Front Panel ----------------------------------- 9-30 Functional List of Error Messages------------7-5 G GP/LP Output Settings----------------------10-25 Graphic Screen---------------------------------1-8 Grounding------------------------------------ 1-14 H Hand Held Bar Code Reader Specifications-----------------B-15 Hardware--------------------------------------- B-1 HGB/HCT Calibration -------------------------6-3 HGB/HCT Calibration Samples ---------------6-3 Host Settings---------------------------------10-17 I ID Reader Settings --------------------------10-30 Inspection before Turning ON the Power ---2-3 Installation and Relocation------------------ 1-14 Installation Environment ------------- 1-14, 1-16 Installation Space ---------------------- 1-15, A-3 Instrument Specifications ------------------- 1-17 IP Output Settings---------------------------10-27 K KX-21N Maintenance Checklist--------------4-2 L LCD Brightness Adjustment ---------------- 1-12 Left Side Interior----------------------------- 9-34 Left Side Panel ------------------------------- 9-33 Levy-Jennings Control (L-J)------------------5-1 Limitation of Hemoglobin ------------------ 2-29 Limitations------------------------------------ 2-28 Location of Control Knobs -------------------8-2 M Maintenance Errors-------------------------- 7-27 Manual Calibration -------------------------- 6-11 Manual Calibration Procedure-------------- 6-12 Manual Discrimination ------------------------3-7 Measuring Unit Hydraulic System Block Diagram --------------------------9-4 Memory Errors------------------------------- 7-23 Menu Tree------------------------------------ 1-20 Monthly Maintenance and Procedure--------4-9 Motor Errors --------------------------------- 7-13 N Names and Functions of Instruments ------ 9-30 Non-Cyanide Hemoglobin Analysis Method ----------------------------------9-2 O Operation Procedure------------------------- 4-41 Option Units------------------------------------1-3 Others ----------------------------------------- 7-25 Outline of Operation---------------------------1-4 Output Format for Host Computer ---------- B-1 Output of Analysis Result to Host Computer ------------------------------ 2-27 Output to Host Computer ------------------- 5-35 Overview of Analysis Modes------------------2-1 Overview of Instrument------------------------1-2 P Panel Keyboard --------------------------------1-7 Password Settings ---------------------------10-32 Patient Limit---------------------------------10-11 Peripheral Settings --------------------------10-36 PLT Discriminator --------------------------- 9-10 Pre-Diluted (PD) Mode---------------------- 2-16 Precision Check --------------------------------6-2 Precision Check Sample-----------------------6-2 Preparation for Calibration--------------------6-2 Prepare Reagent------------------------------- A-6 Pressure and Vacuum Display ---------------8-3 Pressure/Vacuum Errors-----------------------7-7 Print Set Values -----------------------------10-35 Printer Errors -------------------------------- 7-30 Printer Settings ------------------------------10-22 Printing of Analysis Result------------------ 2-25 Printing to Printer---------------------------- 5-31 Procedures in each Analysis Mode-----------2-9 Processing Latest Samples---------------------3-2 Processing Stored Data ---------------------- 3-14 Program Version----------------------------- 7-37 Q QC Analysis Procedure------------------------5-4 QC Analysis Procedure Flow Chart-----------5-4 QC Chart Screen -------------------------------5-2 QC Settings ----------------------------------10-14 Quality Control---------------------------------2-8 Sysmex KX-21N Operator’s Manual -- Revised June 2001 N.A.
  • 359. Sysmex KX-21N Operator’s Manual -- October 1999 N.A. iii R RBC Discriminator--------------------------- 9-10 RBC/PLT Analysis Flow -----------------------9-7 Rear Panel ------------------------------------ 9-35 Reference Values-------------------------------6-3 Reinstalling the Program --------------------A-13 Remove Shipping Clamps-------------------- A-4 Replace Fuse---------------------------------- 4-36 Replace Printer Paper------------------------ 4-37 Replace Waste Tank-------------------------- 4-32 Replenish Reagent --------------------------- 4-33 Reset SRV Cycle Counter ------------------- 4-22 Right Side Panel------------------------------ 9-32 S Select QC File ----------------------------------5-6 Set Printer Paper -----------------------------A-10 Set TARGET/LIMIT Values ------------------5-8 Shutdown Procedure------------------------- 2-32 Software---------------------------------------- B-3 Start-up Procedure-----------------------------2-3 Status Display -------------------------------- 7-34 Status Display Messages ----------------------1-9 Stopping the Pneumatic Unit --------------- 2-31 Stored Data Screen--------------------------- 3-15 Supplies List---------------------------------- 4-40 Supplies Replacement ----------------------- 4-33 System Setup --------------------------------- 10-3 T Temperature Errors-------------------------- 7-16 Transducer Errors---------------------------- 7-15 Troubleshooting Guide------------------------7-7 Turn Power ON ------------------------------A-13 Turning ON the Power and Self-Check------2-5 W WBC Discriminator -------------------------- 9-10 WBC/HGB Analysis Flow----------------------9-5 Weekly Maintenance and Procedure ---------4-7 When You Suspect a Trouble -----------------7-2 Whole Blood (WB) Mode---------------------2-9 X X Control---------------------------------------5-1 Sysmex KX-21N Operator’s Manual -- Revised February 2000 N.A.