KX21 Operator Manual

OPERATOR’S MANUALAUTOMATED HEMATOLOGY ANALYZER KX-21N CHAPTER 1: CHAPTER 2: CHAPTER 3: CHAPTER 4: CHAPTER 5: CHAPTER 6: CHAPTER 7: CHAPTER 8: CHAPTER 9: CHAPTER 10: APPENDIX A: APPENDIX B: INDEX INTRODUCTION SAMPLE ANALYSIS DISPLAY AND PROCESSING OF ANALYSIS RESULTS MAINTENANCE AND SUPPLIES REPLACEMENT QUALITY CONTROL CALIBRATION TROUBLESHOOTING ADJUSTMENT FUNCTIONAL DESCRIPTION INSTRUMENT SETUP INSTALLATION TECHNICAL INFORMATION SYSMEX CORPORATION KOBE, JAPAN Copyright © 1999 by SYSMEX CORPORATION All rights reserved. No part of this Operator’s Manual may be reproduced in any form or by any means whatsoever without prior written permission of SYSMEX CORPORATION. Code No. 461-2265-5 PRINTED IN JAPAN Date of Issue: October 1999 • • • • • • 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. 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 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. 2. 3. Accident, neglect or willful mistreatment of the product Failure to use, operate, service, or maintain the product in accordance with the applicable Sysmex Operator's Manual Failure to use the appropriate reagents or chemicals specified for the product Sysmex KX-21N Operator’s Manual -- October 1999 I 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. WARNING • If this sign is ignored and the instrument is operated incorrectly, there is CAUTION 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. CAUTION Clinical judgments by physicians should take into account results from clinical examinations and other test results besides hematology result. II Sysmex KX-21N Operator’s Manual -- October 1999 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 1999 III 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. IV Sysmex KX-21N Operator’s Manual -- October 1999 direct sunlight. If it spills. • Handle a reagent gently to prevent formation of bubbles. Sysmex KX-21N Operator’s Manual -. dirt. • Do not use reagents which are out of the expiration date. It is hazardous. Use of Instrument • When performing maintenance work or inspection. Do not use substitute parts. use specified tools and parts. and confirmation of initial operation must be done by Sysmex service representative. contact Sysmex service representative for repair. • Unpacking. • Do not install the instrument near a chemical storage or a place where a gas is generated. Environment for Use • Install the instrument in a place which is not subject to water splash. wipe it off immediately using a wet cloth or the like. • Do not give the instrument a strong vibration or impact. • Those who have no or only limited experience in using reagents are recommended to have guidance or assistance of those with sufficient experience. a person in charge of it should take steps within the range specified in the OPERATOR’S MANUAL. • Do not bring your body or clothes close to the instrument. or bacteria to come in touch with the reagent. installation.CAUTION Use of Reagents • After unpacking. be sure not to allow dust. • Take care not to spill a reagent. As to troubles other than mentioned in it. etc. dust. or modify the instrument.October 1999 V . high humidity. • If the instrument has developed a trouble by any chance. • Install the instrument in a place which is not subject to adverse effects of high temperature. • Follow other instructions described on the Package Insert on each reagent. and the data analysis setting such as data error judgment. Describes scheduled maintenance and replacement method of supplies such as reagent. Describes procedures for start-up of the instrument. and unit. and the process of the latest sample/stored data. Describes the installation method of the KX-21N. Describes the displayed content of the analysis data. Describes execution procedures of the X control and LJ control for quality control. Chapter 3: Display and Processing of Analysis Results Maintenance and Supplies Replacement Quality Control Calibration Troubleshooting Adjustment Functional Description Instrument Setup Installation Technical Information Chapter 4: Chapter 5: Chapter 6: Chapter 7: Chapter 8: Chapter 9: Chapter 10: Appendix A: Appendix B: VI Sysmex KX-21N Operator’s Manual -. and shut-down. Describes error messages and troubleshooting. measurement of the sample.STRUCTURE OF THIS MANUAL Read this manual carefully so you will be able to use the instrument to its full extent. Describes the method of pressure adjustment based on the troubleshooting. Describes procedures for automatic/manual calibration. and operate it correctly. time. Technical reference data describing the specification for host output format. Also describes the manual analysis and the external output. This manual contains ten Chapters and APPENDICES as listed in the following: Chapter 1: Chapter 2: Introduction Sample Analysis Describes overview of this instrument. including the outline of the instrument. Describes the system environment setting such as date. and messages. operation procedure. Describes the analyzing principles of this instrument and names of the components. Summarizes the operation method for analyzing the sample. and cautions during installation.October 1999 . Carefully read the OPERATOR'S MANUAL for correct use of the unit. It will continue to be of your service in finding specific information about this instrument.INTRODUCTION Thank you for purchasing the Sysmex® Automated Hematology Analyzer KX-21N.October 1999 VII . Keep this MANUAL handy after reading. Sysmex KX-21N Operator’s Manual -. " "WB" • The name of menu appears within quotation marks. VIII Sysmex KX-21N Operator’s Manual -. For example: "Stand-by. For example: "2: Quality Control. CAUTION: • Indicates what we would like you to know to maintain instrument performance and prevent its damage. For example: [SELECT]. WARNING CAUTION • If this sign is ignored and the instrument is operated incorrectly. [ ] • The display on LCD appears within quotation marks. • Due to the improvement of the product. this manual uses the conventions as shown below. Document Conventions In explaining operation. there is a potentially hazardous situation which could result in death or serious injury of an operator. • The keys on the panel keyboard are expressed within square brackets.PREMISES FOR SIGNS Meaning of Signs • If this sign is ignored and the instrument is operated incorrectly. NOTE: • Indicates information which will come handy in operating the instrument. or grave property damage. adverse effect on output results. or will cause property damage. [ENTER]. there is a potentially hazardous situation which may result in injury of an operator.October 1999 ." "6: Settings" NOTE: • LCD and printing described in this manual may differ from that in practice. the content of this manual may not conform with the product. ............................................................. 1-8 8.................................... 2-1 1. 14....................................1 Whole Blood (WB) Mode ............. 1-5 PANEL KEYBOARD ............................................................1-12 ALARM SOUNDS.1-20 9..............1 Display of Analysis Result .............................................. 8............... 3...................................................... 5.2 Grounding ..........2-24 5.2 Printing of Analysis Result..............2-25 5...........................................2 Limitation of Hemoglobin...2-31 EXECUTION OF SHUTDOWN.................................................................................................... 2........1-16 INSTRUMENT SPECIFICATIONS .... 2-8 PROCEDURES IN EACH ANALYSIS MODE..... 1-3 OUTLINE OF OPERATION ................... 9. 13...................................................... 2-3 2.......1 Cell Count Parameters . 2-9 4........................................... 1-8 8............2 Analysis Procedure Flow Chart................. 4.....1 Shutdown Procedure .. 4...........................................................................................1-14 12... 2...............October 1999 i ...... Sysmex KX-21N Operator’s Manual -.... 2-9 4..2 Status Display Messages........2-32 9.................................1-17 MENU TREE ........................................................ 7..................2-28 6.......2-30 STOPPING THE PNEUMATIC UNIT ................2-16 DISPLAY AND PRINTING OF ANALYSIS RESULT ............................................1 Installation and Relocation .......1-13 INSTALLATION ENVIRONMENT ..... CHAPTER 2: SAMPLE ANALYSIS 1.2-28 6......2-29 EXPECTED RESULTS .....................................................................1-14 12......... INTRODUCTION.............................................................. 8....................................................................... INTRODUCTION............... 1-1 OVERVIEW OF INSTRUMENT...... 1-7 GRAPHIC SCREEN .............................2-24 5...............1-13 CONTENTS OF PACKAGE .. 2-1 1..2 Inspection before Turning ON the Power ...............2-32 6................................... 10............ 3...................................................................................... 2-5 QUALITY CONTROL ...................4 Installation Environment .......................................3 LCD Brightness Adjustment .... 2-3 2...............KX-21N OPERATOR’S MANUAL TABLE OF CONTENTS CHAPTER 1: INTRODUCTION 1......................................................................2-27 LIMITATIONS .............................................3 Installation Space ..... 1-9 8............................................ 11......................................... 5..................1 Contents of Display ................... 1-2 OPTION UNITS... 1-4 ANALYSIS PARAMETERS .................. 7............. 2-2 START-UP PROCEDURE...........................................................2 Turning ON the Power and Self-Check ............................1 Overview of Analysis Modes ......3 Output of Analysis Result to Host Computer .......................1-12 EMERGENCY STOP PROCEDURE ..1-14 12................... 12..................................................... 1-4 AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT............................................... 6....................1-15 12.....................2 Pre-Diluted (PD) Mode ....................................... .........................4 Supplies List.................................. 4-9 5.....2 Clean Rinse Cup .........3 Deletion ......................................................4-32 SUPPLIES REPLACEMENT ............October 1999 ................4-16 6............................................. 4-1 KX-21N MAINTENANCE CHECKLIST ............. 4-41 ii Sysmex KX-21N Operator’s Manual -...1 Executing and Quitting Stored Data Processing Program... 3-23 CHAPTER 4: 1.............. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3......... 4-2 DAILY MAINTENANCE AND PROCEDURE ....1 Clean SRV Tray .....2 Replace Fuse ..................1 Clean TD Chamber and Diluted Sample Line (Shutdown) ..........2 Reset SRV Cycle Counter ..2 Check Trap Chamber Level and Discard ............... MAINTENANCE AND SUPPLIES REPLACEMENT 8...................................... 4-7 4............................................................................................................................4 Replace Waste Tank..................................................... 2............ 3-20 3...................................... INTRODUCTION. 3-2 2............ 3-11 PROCESSING STORED DATA ............ 4-16 6.................... 4-41 9............................4-24 7....... 6................ 3-15 3................................. 3 4... 9....1 Operation Procedure .......................................4-37 8.4-36 8.......5 Correcting a Sample Number ......................................................3 Replace Printer Paper ................................4-26 7.............................4-22 AS-NEEDED MAINTENANCE AND PROCEDURE ....................................2 Stored Data Screen .......................4-40 CONFIRMATION OF CYCLE NUMBER............................... 4-4 3......................... 4-24 7......4 External Output ..............3 Clean WBC/RBC Transducer Aperture . INTRODUCTION... 4-4 3..................................1 Clean Sample Rotor Valve (SRV)................................... 3-2 2......... 4-33 8...................4-12 EVERY 3-MONTH MAINTENANCE AND PROCEDURE............................................................................4-28 7.... 5. 3-7 2...............................................................................1 Clean Waste Chamber (Rinse Sequence)........................................................ 4-9 5.....................................4-33 8........................3 External Output ................................... 3-14 3.......................... 7.1 Replenish Reagent.... 4-7 MONTHLY MAINTENANCE AND PROCEDURE.1 Display of Analysis Result ..........2 Clean Transducer (Rinse Sequence) ............................. 2.................... 3-14 3..............................2 Manual Discrimination .............................................. 3-21 3............... 4-6 WEEKLY MAINTENANCE AND PROCEDURE ........ 3-1 PROCESSING LATEST SAMPLES ....................CHAPTER 3: 1.1 Auto Rinse....................... ......................................................2 Output to Host Computer..4 Calibration Flow Chart..................................................5-31 4..........7 Execute L-J Control .......................................................... 6-1 1...................................... 4...................5-27 EXTERNAL OUTPUT .......................... 5-4 2.... 5-1 1............... INTRODUCTION...................................................... 5-1 1.............CHAPTER 5: QUALITY CONTROL 1... 3................................3 QC Chart Screen ....................................6-13 2................. 6-2 AUTOMATIC CALIBRATION .................... 5-8 2..6-10 CALIBRATION HISTORY PRINT ........ CHAPTER 6: CALIBRATION 1.......... 6-9 3....5 Set TARGET/LIMIT Values................... 6-1 1.5-31 4...........2 Manual Calibration Procedure ......1 Executing Automatic Calibration Program ..............1 X Control ................................................................................................................................. 5-2 QC ANALYSIS PROCEDURE .........................3 Select QC File......... 6-1 1......5-10 2.................3 Reference Values .......................... 3..........1 Calculating Calibration Value ...... 5-1 1.............2 Automatic Calibration Procedure......2 Execute QC Program..................................................... 5-6 2......................................6 Execute X Control..... 5-4 2..................................................... 6-4 MANUAL CALIBRATION ...................................................October 1999 iii ..... Sysmex KX-21N Operator’s Manual -..........1 Calibration Execution Timing ........................................................................ 5-7 2..................... 5-5 2.......................................5-26 DELETION............................ 6-3 2.................8 Exit from QC Control Program ................................1 QC Analysis Procedure Flow Chart.................................................. 6-9 3.....................4 Erase All ..........................................................5-19 2........2 Samples Used for Calibration...5-35 2...... INTRODUCTION............................................................. 6-1 1..........2 Levy-Jennings Control (L-J) ........................................................................................1 Printing to Printer......................................... 6-3 2... 4. ............ 7-13 3........ 7-23 3.......... 8-6 iv Sysmex KX-21N Operator’s Manual -....................2 Chamber Errors ........ INTRODUCTION ........9 Maintenance Errors .................................... 7-37 3.......... 8-1 ADJUSTMENT OF PRESSURE AND VACUUM . 7-36 PROGRAM VERSION............ 7-30 3............................................ 8-3 2...................................... 5............................................................................................................................3 Adjusting Pressure to 0............................. 7-15 3........................................... 2......................1 Alphabetical List of Error Messages Displayed on Analysis Screen..........3 Motor Errors ...... 7-3 2.....................................CHAPTER 7: TROUBLESHOOTING 1.................................. 7-16 3.......................................................6 Analysis Errors .................. 7-5 TROUBLESHOOTING GUIDE .. 8-5 2................ 4................................4 Adjusting Vacuum to 250 mmHg ..............................................3 Functional List of Error Messages............................................ 7-25 3................. 7-4 2...7 Memory Errors ....... 8-2 2...................................... 2..........8 Others.......................................................... 7-27 3..............................................10 Printer Errors .... 6.................... 8-2 2.............. 7-33 STATUS DISPLAY ... INTRODUCTION .................October 1999 ....................................... CHAPTER 8: ADJUSTMENT 1..............................1 Pressure/Vacuum Errors ......................5 Temperature Errors ............................................ 7-10 3..5 kg/cm2 .................................... 7-7 3............11 External Device Errors ........................... 7-17 3....................2 Alphabetical List of Error Messages Displayed on HELP Screen .... 7-34 ERROR HISTORY PRINT .............2 Pressure and Vacuum Display .......................1 Location of Control Knobs . 7-1 WHEN YOU SUSPECT A TROUBLE.. 7-7 3..................................................... 7-2 2.......4 Transducer Errors .............................. ......3 Right Side Panel ....................... 9-30 8............................................... 9-34 8.... 7..........2 GP/LP Output Settings........................... 9-10 5............................... 9-5 4................................................................................... 9-9 BLOOD CELL DISCRIMINATION CIRCUIT .......... 9..... 10-22 7.................................1 WBC/HGB Analysis Flow ................................................... 9-2 MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM...... 9-4 CBC ANALYSIS.....6 Rear Panel ..............2 Non-Cyanide Hemoglobin Analysis Method ............CHAPTER 9: FUNCTIONAL DESCRIPTION 1........ 9-7 4............. 10..............................................1 DC Detection Method............... 10-35 PERIPHERAL SETTINGS . 6.1 Analysis of WBC Histogram........ 2.................... 7............. 9-10 5......... INTRODUCTION............. 10-30 PASSWORD SETTINGS ....................................................... 10-38 8...................1 Front Panel . 10-32 PRINT SET VALUES ..............5 Left Side Interior...... 10-17 PRINTER SETTINGS ..................... 10-36 FACTORY SETTINGS ............... 4........ 9-2 2..................................................................................................................... 10-3 DATE/TIME SETTINGS .................................4 Left Side Panel ...........2 Analysis of RBC/PLT Histogram .......................................................................................................................... 9-1 DETECTION PRINCIPLE...........October 1999 v ...................................................... 11............... 9-11 6................ 9-5 4.......................................................2 RBC/PLT Analysis Flow ................................ 3....................................................... CHAPTER 10: INSTRUMENT SETUP 1................................................ 10-23 7.............................3 IP Output Settings .... 9-35 5.................2 Front Interior ..... 10-1 SYSTEM SETUP...... 6........3 PLT Discriminator......1 DP Output Settings ................................................................................................ 9-30 8.... 8............................... 10-8 PATIENT LIMIT.. 9-32 8...2 RBC Discriminator ... 9-11 6......... 9-33 8..... 9-31 8............................. 10-27 ID READER SETTINGS.................................................................................................................. 9-20 ELECTRIC SYSTEM ........................................................ 9-28 NAMES AND FUNCTIONS OF INSTRUMENTS..................... 2...... 5.......3 Calculation of RBC Constant ........................................................ 4......... 10-14 HOST SETTINGS...... 9-10 5............................................................................... 9-10 ANALYSIS OF HISTOGRAM ........................... 10-11 QC SETTINGS ...................................................................................1 WBC Discriminator .. 3....................... 9-2 2..... 12..................................... Sysmex KX-21N Operator’s Manual -........................... INTRODUCTION.............................. 10-25 7................. ......APPENDIX A: INSTALLATION 1...3 Connect STROMATOLYSER-WH......4 Connect Waste Line ...................................................1 Connect Host Computer....... A-9 SET PRINTER PAPER (OPTION) ............ A-12 7.... INTRODUCTION............................................................... OUTPUT FORMAT FOR HOST COMPUTER (Option) ............................ A-6 5... 5.... A-12 TURN POWER ON ..................... and Handy Barcode Reader ......... 2...B-1 1..... A-4 CONNECT TUBE......................... A-1 CHECK BEFORE INSTALLATION ........................................ A-13 REINSTALLING THE PROGRAM.........................B-1 1......................1 Prepare Reagent..............................................................................................................2 Software............... A-10 CONNECT POWER CORD AND CONNECTING CABLES ................................................................2 Connect CELLPACK ..................... A-2 INSTALLATION SPACE... 8...........................1 Hardware................... 9.......... A-3 REMOVE SHIPPING CLAMPS............October 1999 .. Printer.......................................... 4............. A-6 5..B-3 INDEX vi Sysmex KX-21N Operator’s Manual -...... APPENDIX B: TECHNICAL INFORMATION 1..... A-12 7.............2 Connect Power Cord ................................................. A-6 5.................................................... 7... A-13 6........ A-8 5.............. 3............................................ ..... 2..................... 13............1-12 EMERGENCY STOP PROCEDURE.......................................2 Grounding ........................................ 1-4 ANALYSIS PARAMETERS..............................CHAPTER 1 INTRODUCTION 1............................................................3 Installation Space..............................................................1-12 ALARM SOUNDS .............. 1-14 12.... 1-8 8............................................................................. 14..............2 Status Display Messages ..............................................................................................................................4 Installation Environment .......... 1-13 CONTENTS OF PACKAGE............... 7... Sysmex KX-21N Operator’s Manual -.1-16 INSTRUMENT SPECIFICATIONS...... 12......... 1-2 OPTION UNITS...............................1-14 12.......... 1-7 GRAPHIC SCREEN........... 1-15 12................ 8...............1-17 MENU TREE............... 6....1 Contents of Display............October 1999 ................................. 3................ 1-5 PANEL KEYBOARD .................. 1-13 INSTALLATION ENVIRONMENT.. 11....... 1-3 OUTLINE OF OPERATION...........................1 Installation and Relocation ............ INTRODUCTION ............................................ 1-20 9....... 1-4 AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT..............................................................................1-14 12............................................................................................ 4.............. 1-1 OVERVIEW OF INSTRUMENT.......................3 LCD Brightness Adjustment.................. 5..................... 1-9 8............. 1-8 8.............. 10..................................... The KX-21N processes approximately 60 samples an hour and displays on the LCD screen the particle distribution curves of WBC. INTRODUCTION The Sysmex® KX-21N is an automatic multi-parameter blood cell counter for in vitro diagnostic use in clinical laboratories. and platelets. as the analysis results. Instrument Specifications The instrument specifications are described. and the messages on the LCD screen. required equipment. RBC. Sysmex KX-21N Operator’s Manual -. 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. along with data of 19 parameters. Precautions at Time of Installation Explanation is given on the matters that need to be confirmed before installation. descriptions and functions of the keys on panel keyboard. Main Points of Analysis Procedure Explanation is given on the procedure for implementing each analysis mode. environmental conditions. Menu Tree This chapter describes the KX-21N menu tree and the corresponding chapters which explain the usage of the menus. such as installation space. analysis procedure.INTRODUCTION 1. etc.October 1999 1-1 . Chapter 1 introduces the overview of the instrument. also using the DC detection method. The HGB detector block measures the hemoglobin concentration using the non-cyanide hemoglobin method. The RBC count and platelets are taken by the RBC detector block. The KX-21N employs three detector blocks and two kinds of reagents for blood analysis. OVERVIEW OF INSTRUMENT The KX-21N performs speedy and accurate analysis of 19 parameters in blood and detects the abnormal samples. The WBC count is measured by the WBC detector block using the DC detection method.INTRODUCTION 2.October 1999 . the instrument displays abnormal analysis data with abnormal marks attached on the LCD screen. Figure 1-2-1: Overview of KX-21N 1-2 Sysmex KX-21N Operator’s Manual -. Thus displayed analysis data allows detecting those samples which are outside the tolerance and need further analysis and reconsideration. To assure easy sorting of abnormal samples in the laboratory. Page P (LP-1700): 660-0121-9 Color P (BCJ-430J): 660-0135-1 Prints the analysis data obtained from the KX-21N onto a ticket format. BCH5402-9019: 281-9138-8 Figure 1-3-2: Handy Barcode Reader Sysmex KX-21N Operator’s Manual -. reads the barcode that are affixed to the tubes. DP-510: 943-0571-9 (N.October 1999 1-3 . 240 V) • Data Printer: Figure 1-3-1: Data Printer • Handy Barcode Reader: During analysis. 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.K. 117 V) 943-0581-6 (Europe..America.INTRODUCTION 3. 220 V) 943-0591-3 (U. and automatically sets the sample ID numbers. Set sample to the sample probe. Select pre-diluted mode.INTRODUCTION 4. Prepare analysis samples in pre-diluted mode (1:26 dilution). when left non-operating for 15 minutes. Table 1-4-1: Outline of Operation • The work by an operator is shown in shaded cells. Execute shutdown. Ready Check after analysis. 5. • Ready : "Ready" is displayed on the LCD screen.October 1999 . automatically stops the pneumatic unit. Set sample No. and data processing can be performed. • End analysis. with this function. Set sample No. 1-4 Sysmex KX-21N Operator’s Manual -. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT The KX-21N. Press the start switch. • Self-check • Background check Ready Select whole blood mode. In this state. Whole blood mode Pre-diluted mode Check before turning ON the power. • Execute analysis. In addition. Turn off the power. settings. 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. analysis-ready status can be resumed faster than by turning on the power. various operations including analysis. This function saves power consumption and extends component service life. Turn ON the power. It is also possible to manually stop the pneumatic unit through the Select Menu screen. INTRODUCTION 6. which is calculated by Hgb/RBC. MCH (Mean RBC hemoglobin) Mean hemoglobin volume (pg) per RBC. MCHC (Mean RBC hemoglobin concentration) Mean hemoglobin concentration (g/dL).October 1999 1-5 . which is calculated by Hgb/Hct. eosinophils and monocytes (middle cells) to whole WBC NEUT% [W-LCR] (WBC-Large Cell Ratio) Ratio (%) of neutrophils (large cells) to whole WBC LYM# [W-SCC] (WBC-Small Cell Count) Absolute count of lymphocytes (small cells) in 1 µL of whole blood MXD# [W-MCC] (WBC-Middle Cell Count) Absolute count of the basophils. eosinophils and monocytes (middle cells) in 1 µL of whole blood NEUT# [W-LCC] (WBC-Large Cell Count) Absolute count of neutrophils (large cells) in 1 µL of whole blood RBC (red blood cell) (Analysis principle: DC detection method) RBC count in 1 µL of whole blood HGB (Hemoglobin) (Analysis principle: Non-Cyanide hemoglobin analysis method) Volume (gram) of hemoglobin in 1 dL of whole blood HCT (Hematocrit value) (Analysis principle: RBC pulse height detection method) Ratio (%) of whole RBC volume in whole blood MCV (Mean RBC volume) Mean RBC volume (fL) in whole blood. 4) 5) 6) 7) 8) 9) 10) 11) 12) 13) Sysmex KX-21N Operator’s Manual -. which is calculated by Hct/RBC. ANALYSIS PARAMETERS This instrument analyzes the following parameters using three detector blocks and two kinds of reagents: 1) 2) 3) WBC (white blood cell) (Analysis principle: DC detection method) WBC count in 1 µL of whole blood LYM% [W-SCR] (WBC-Small Cell Ratio) Ratio (%) of lymphocytes (small cells) to whole WBC MXD% [W-MCR] (WBC-Middle Cell Ratio) Ratio (%) of the summation of basophils. Not a reportable parameter. RDW-SD (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.SD) The distribution width (fL) at the height of 20% from the bottom when the peak RBC particle distribution curve is taken as 100%. only the CBC8 parameters are output. MPV (Mean platelet volume) Mean volume of platelet (fL) P-LCR (Large platelet ratio) * Ratio (%) of large platelet volume exceeding 12 fL to the platelet volume • When analyzing in the pre-diluted mode. 15) 16) 17) 18) 19) NOTE: * For Investigational Use Only in the United States of America.October 1999 .INTRODUCTION 14) RDW-CV (RBC distribution width . 1-6 Sysmex KX-21N Operator’s Manual -. PLT (Platelet) (Analysis principle: DC detection method) Platelet count in 1 µL of whole blood PDW (Platelet distribution width)* The distribution width (fL) at the height of 20% from the bottom with the peak of platelet particle distribution curve taken as 100%. the alarm stops and the HELP screen appears. 7 4 1 0 8 5 2 -/.. By pressing [HELP] key. . the cursor moves to the previous or the next item. Used to enter numerics such as a sample No.INTRODUCTION 7. Used to execute shutdown program. the decimal point of a set value. and set value. Press this key to display the Select Menu screen. C . Sysmex KX-21N Operator’s Manual -. PANEL KEYBOARD The KX-21N is provided with the 22-key panel keyboard. etc. ENTER SELECT MODE HELP SHUTDOWN 0-9 − /. Used to delete characters when entering numerics. Used when an error has occurred.October 1999 1-7 . Table 1-7-1: Functions of Panel Keyboard CAUTION: • When the alarm is sounding after an error. Function Used to set a sample No. and to select Manual Discriminator. While the alarm is sounding. 9 6 3 C SAMPLE No. ENTER SELECT MODE HELP SHUTDOWN Figure 1-7-1: Panel Keyboard Name SAMPLE No.. Used to fix a sample No. the Analysis screen returns. and stop the alarm. occurred. etc. Each time a key is pressed. Used to changeover analysis mode (whole blood mode/pre-diluted mode). When you press it while the Select Menu screen is displayed. the keys other than [C] key and [HELP] key cannot be used. Used to select a menu. selected menu. Used to select a menu. press [C] key to stop it or press [HELP] key to display the HELP screen. Used to select conditions when setting. Used to enter "−" (hyphen) of a sample No. 0 0. GRAPHIC SCREEN 8 .00 0. Status of the unit is displayed.0 0.0 0. Displays the analysis mode for the sample.0 0. The area for displaying analysis result Table 1-8-1: Contents of Display 1-8 Sysmex KX-21N Operator’s Manual -.0 0.0 0.0 0.0 WBC RBC HGB HCT MCV MCH MCHC PLT 0. Sample Analysis Mode Analysis Progress Status Status Display Menu Display Area Analysis Result Display Area Contents of Display Displays the sample No.0 0.0 0. Useable menus for each screen are displayed. Status Display Analysis Progress Status No. 1 Contents of Display Next Sample No.1 No.0 Analysis Result Display Area LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR 1:M.0 0 Ready WB Sample Analysis Mode 31/12 10:20 0. to be analyzed next. : whole blood mode : pre-diluted mode With the start-to-end analysis progress classified into six steps.0 0.Discri. 2:Output Menu Display Area Figure 1-8-1: Graphic LCD Name Next Sample No.0 0. the present progress status is displayed.0 0.October 1999 .INTRODUCTION 8.0 0.0 0.0 0. Sysmex KX-21N [00-01] Please wait.October 1999 1-9 . When the power is turned ON. Auto rinse is also performed when "5: Auto Rinse" in the Select menu is executed and when [SHUTDOWN] key is pressed. 2 Status Display Messages The KX-21N displays instrument status message on the LCD screen. When the power is turned ON. This section gives the meanings of status messages displayed on the LCD screen. followed by auto rinse of the hydraulic system. which indicates the version of the unit control program. *Auto Rinse* Please wait. the instrument starts self-check and motor check. rinse sequence is automatically extended. When an automatic background check shows a background count exceeding the permissible background count level. The hydraulic system is undergoing Auto Rinse. [00-01] appears briefly in the right lower corner. the instrument checks itself automatically. Display Message Meaning The instrument is making self-check. When the power is turned ON.INTRODUCTION 8 . Sysmex KX-21N Operator’s Manual -. 0 WL+000.0 WL+000.0 0.0 WL+000.0 0. WL+000.0 WL+000. to be analyzed next.0 0.0 WL+000.0 WL+000.0 WL+000.0 WL+00.0 WL+000.0 0. FILE No.0 0.0 WL+000.1 X1 WBC RBC HGB HCT MCV MCH MCHC PLT 2:Output QC Ready X2 X Judgement The instrument is ready for X control.0 0.October 1999 .1 No.0 +000. "FILE No.0 +000." in the left upper corner indicates the sample No.0 0.0 +000. FILE No.0 WL+00000 LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR 1:M.0 0.0 WL+000.1 No. "FILE No.0 0 Ready WB LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR 31/12 10:20 0.0 0.Discri.0 0.0 Meaning The instrument is ready for analysis in the whole blood mode.0 The instrument is ready for pre-diluted mode analysis.1 WBC RBC HGB HCT MCV MCH MCHC PLT QC Ready Data Judgement The instrument is ready for L-J control.0 0.Discri.0 0.0 0." in the left upper corner shows the sample No.0 WBC RBC HGB HCT MCV MCH MCHC PLT 0.INTRODUCTION Display Message No.0 WL+000. 1" in the left upper corner shows QC file No.0 0.0 0.0 WBC RBC HGB HCT MCV MCH MCHC PLT 2:Output Ready PD 31/12 10:20 WL+000. 1:M. "No.00 WL+000. 1-10 Sysmex KX-21N Operator’s Manual -. No.00 0. to be analyzed next. "No. 1" in the left upper corner shows QC file No. * Ready Sysmex KX-21N Operator’s Manual -.INTRODUCTION Display Message *Change Mode* Meaning The whole blood mode is turning into the prediluted mode. the compressor power is turned OFF and this message is displayed. Press the [START] switch to get ready for analysis.123456789-12345 PU Sleeping Not Ready An error occurs. No. When data is automatically output to the host computer. Please wait.123456789-12345 Rinsing No. No. Momentary power failure occurred.123456789-12345 Replenish Diluent Not Ready No. the error message appears in reversed display in the right upper area of the LCD screen.October 1999 1-11 . " * " mark lights up in the right upper corner of the screen. and counted. diluted. (When an error occurs.123456789-12345 Aspirating The sample is being aspirated in pre-diluted mode analysis. No. making analysis impossible. Hydraulic line is being rinsed.123456789-12345 Aspirating The sample is being aspirated in whole blood mode analysis.) When operation has been suspended over 15 minutes. this message appears when the unit is started next time. No.123456789-12345 Analyzing Samples are being aspirated. When the power is turned off without making shutdown process or when power outage caused the instrument to stop. or the pre-diluted mode is turning into the whole blood mode. turn off the instrument power switch.INTRODUCTION 8 . Light Dark Figure 1-8-2: Brightness adjustment knob NOTE: • If a key input or an operation has not been performed for a fixed time. etc.October 1999 . the LCD back-light will become slightly dimmer (back-light darkening function). 1-12 Sysmex KX-21N Operator’s Manual -. EMERGENCY STOP PROCEDURE When there arises the need to stop the instrument urgently because of power outage. in the laboratory. press any key.. 3 LCD Brightness Adjustment Open the front cover of the instrument. 9. To return the LCD to its original brightness. 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. . beep" when aspiration is finished. "beep. Input error sound (short beep) Sounds about 1 second when a wrong key is pressed on the panel keyboard. 2. check the package to see that there is no external damage. To confirm the contents of the package. beep. 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.) continue from pressing the start switch until aspiration ends. Sound at sample aspiration Usually: A single "beep" when the start switch is pressed...INTRODUCTION 1 0 . ALARM SOUNDS The KX-21N indicates different situations by five kinds of alarm sounds: 1. 4. "0" or in pre-diluted mode: Beep sounds (beep. 3. refer to "Appendix A: Installation. Key sound (single beep) Sounds about 0. Sysmex service representative will unpack. CONTENTS OF PACKAGE The instrument is fully inspected before leaving the factory and carefully packed to withstand shocks in transit.October 1999 1-13 . Upon arrival. Sample No. install the instrument. and make initial settings.1 second when a key on the panel keyboard is pressed. 1 1 ." Sysmex KX-21N Operator’s Manual -. NOTE: • The number of power supply sockets required is 3 including optional Graphic Printer and optional Data Printer.October 1999 .INTRODUCTION 1 2 . resulting in any trouble. INSTALLATION ENVIRONMENT 12. simply plug it to the socket. 220 VAC Spec. In case relocation becomes necessary after installation. warranty would not be applied even in the warranty period. 117 VAC Spec. contact your Sysmex service representative. Inadequate grounding could cause electrical shocks.1 Installation and Relocation The KX-21N is installed by Sysmex Service representative. etc. WARNING • Make sure to ground the instrument. of the instrument should be conducted by the customer. When the power supply socket is 3-prong with grounding. Pay careful attention to this because if relocation. 12.2 Grounding The instrument power supply cord uses the 3-prong plug. 1-14 Sysmex KX-21N Operator’s Manual -. Figure 1-12-1: Plugs 240 VAC Spec. and the diluent (CELLPACK) tube up to 2 m long. The power supply cord is 1. the waste tube up to 6 m long. The instrument dimensions are shown below. it is important to install it at an appropriate place: • Choose a place that is close to the power supply and proper waterway. provide at least 50 cm distance from the wall to side.October 1999 1-15 . it may be impossible to have reagent aspirated.3 Installation Space To ensure that the instrument fulfills its function. possibly damaging the instrument. Sysmex KX-21N Operator’s Manual -. Avoid setting CELLPACK at a level higher than the instrument.8 m long. otherwise. Width (mm) 420 Depth (mm) 355 Height (mm) 480 Weight (kg) 30 Main Unit Table 1-12-1: Instrument Dimensions 480 420 355 Figure 1-12-2: Instrument Dimensions CAUTION: • When the diluent (CELLPACK) tube is more than 2 m long. reagent may flow into the vacuum line. and top panels. • Choose a place where reagent is easy to handle. You may need some more desktop space if optional Graphic Printer and Data Printer are provided.INTRODUCTION 12. Giving consideration to heat radiation by the instrument. rear. • Secure a place spacious enough for maintenance and service. • Use it at a relative humidity range of 30% . • Avoid a place that can be exposed to direct sunlight.INTRODUCTION 12. • When air conditioning is used.4 Installation Environment • Use the instrument at an ambient temperature of 15°C .85%. 1-16 Sysmex KX-21N Operator’s Manual -. • Choose a well-ventilated place.October 1999 . • Avoid a place close to a wireless telegraph or communication facility where high frequency waves can be generated or radio interference can occur. the maximum cooling capacity of about 172 kcal/hour is required to offset the heat from the instrument.30°C (optimum: 23°C). • Avoid a place that can become extremely hot or cold. 1.0 . MCV (mean corpuscular volume). MXD# (W-MCC). PLT (platelet).1999 (×103/µL) Reagent Diluent: CELLPACK WBC/HGB lyse reagent: STROMATOLYSER-WH Detergent CELLCLEAN Consumption of reagent (per sample) Diluent (CELLPACK): Approx.9 (×103/µL) RBC 0. Not a reportable parameter.00 .0 mL Throughput Approx. MPV (mean platelet volume). RBC (Red Bloodcell Count). Display range WBC 0.INTRODUCTION 1 3 . RDW-CV (RBC distribution width-coefficient of variation).October 1999 1-17 . 60 samples/hour Analysis principle WBC: DC detection method RBC: DC detection method HGB: Non-cyanide hemoglobin analysis method Sysmex KX-21N Operator’s Manual -. P-LCR (platelet large cell ratio)*. HCT (hematocrit). HCT. LYM# (WSCC). MXD% (W-MCR). MCV. * For Investigational Use Only in the United States of America. RDW-SD (RBC distribution width-standard deviation). NEUT% (W-LCR). PLT. MCH (mean corpuscular hemoglobin). MCHC.99 (×106/µL) HGB 0 .19. MCHC (mean corpuscular hemoglobin concentration). the parameters in pre-diluted mode are eight: WBC. INSTRUMENT SPECIFICATIONS Analysis parameters: WBC (White Bloodcell Count). PDW (platelet distribution width)*. HGB.299. HGB (hemoglobin).25.0 (g/dL) PLT 0 . MCH. LYM% (W-SCR). NEUT# (W-LCC) However. RBC. 30 mL WBC/HGB lyse reagent (STROMATOLYSER-WH): Approx. 00 × 106/µL or over) 2.05 × 106/µL or less ±8% or ±15 × 103/µL or less 1-18 Sysmex KX-21N Operator’s Manual -.0% or less 3.0% or less PDW 12.0 × 103/µL or over) RBC (4.03 × 106/µL or less ±5% or ±10 × 103/µL or less ±5% or ±0.0% or less RDW-SD or RDW-CV 4.0% or less LYM% (W-SCR) 15.0% or less NEUT% (W-LCR) 15.0 × 103/µL or over) 30.0% or less 9.0% or less 3.0% or less MXD% (W-MCR) (12% or over) 30.5% or less HCT 2.0% or less HGB 1.0% or less MPV 5.0% or less PLT (100 × 103/µL or over) 6.5% or less 3.0% or less NEUT# (W-LCC) 15.0% or less MCHC 2.0% or less MCV 2. 1) Whole blood mode WBC (4.00 × 106/µL or over) HGB HCT MCV MCH MCHC PLT (100 × 103/µL or over) 6.0% or less Accuracy 1) Whole blood mode WBC: RBC: PLT: 2) Pre-diluted mode WBC: RBC: PLT: ±3% or ±0.0% or less 2) Pre-diluted mode WBC (4.5% or less RBC (4.0% or less 3.October 1999 .INTRODUCTION Reproducibility Reproducibility is within the following range at the reliability level of 95%.0% or less LYM# (W-SCC) 15.0% or less MXD# (W-MCC) (1.0 × 103/µL or over) 3.3 × 103/µL or less ±3% or ±0.0% or less 2.2 × 103/µL or less ±2% or ±0.0% or less MCH 2.0% or less 3.0% or less P-LCR 20. 0 .199 (× 103/µL) 200 .2 (g/dL) or less ±2% or less ±1.999 (× 103/µL) (However.0 .0 (g/dL) HCT: 10.0 (g/dL) 10.0 (HCT%) or less ±3% or less ±10 (× 103/µL) or less ±5% or less Blood volume aspirated Whole blood mode: Approx.0 (HCT%) PLT: 10 .9 (× 103/µL) 10.1 .30 .03 (× 106/µL) or less ±3% or less ±0.10. 230 VA or less Dimensions Main Unit: 420 (W) × 355 (D) × 480 (H) mm Weight Main Unit: Approx.7.5% or less PLT: 5% or less ±0.0 kg Sysmex KX-21N Operator’s Manual -.60.00 (× 106/µL) HGB: 0. 30.3 (× 103/µL) or less ±3% or less ±0.99.INTRODUCTION Linearity 1) Whole blood mode WBC: 1. 200 µL (Diluted blood sample) Blood volume required for the pre-dilution is 20 µL or over.00 × 106/µL) Carryover WBC: 3% or less RBC: 1.5% or less HCT: 1.0.0 .9.33.99 (× 106/µL) 1.0 .25.00 .9 (× 103/µL) RBC: 0.October 1999 1-19 . Power supply 117/220/230/240 VAC ± 10% or less (50/60 Hz) Power consumption Approx.3 (HCT%) 33.4 . 50 µL Pre-diluted mode: Approx.5% or less HGB: 1. RBC < 7. Settings Chapter 10.2 4: Drain TD Chamber Chapter 4. 6 Chapter 10. 5. History Chapter 6. 8 8: Password Settings Chapter 10. 1 Chapter 2. Chamber Chapter 4.1 5: Auto Rinse Chapter 4. 5.1 2: Clean Transducer Chapter 4.2 3: Reset SRV Counter Chapter 4.1 6: Settings Chapter 10 1: System Setup 2: Date/Time 3: Patient Limit 4: QC Settings 5: Host Settings 6: Printer Settings Chapter 10. 9 9: Print Set Values 7: Maintenance Chapter 4 Chapter 10. 2.4 Chapter 6. 8. 3.2 Chapter 3. Screen 1: M. 2. 6 00: PU Sleep Chapter 2. 4 Chapter 7. MODE HELP SHUTDOWN Chapter 2. 3 Chapter 6. 2. 4 4: Replace Lyse Chapter 4. MENU TREE Ana. 2 Chapter 5. 6.3 5: Status Display 6: Print Error History 7: Program Version 8: Periph. 7 * * * 7: ID Reader Settings Chapter 10.5 Chapter 5. 4 Chapter 7. 6 *: If set. 5 Chapter 10. 2. 2 Chapter 10.4 Chapter 5. 3 Chapter 10. 2 Chapter 6. 3. 7.October 1999 .INTRODUCTION 1 4 . 4 Chapter 2. 5 Chapter 7. Chapter 3. 2 Chapter 6. 7.3 1: Delete 2: Output 2: Quality Control Chapter 5 1: QC Analyze 2: Settings 3: Erase All 3: Calibration Chapter 6 1: Auto Cal. 2 1: Stored Data Chapter 3 4: Print Rev.3 Chapter 3. Discri. 10 * 1: Clean W. 1-20 Sysmex KX-21N Operator’s Manual -. 4 Chapter 10. 6 SAMPLE No. 9 Chapter 7. 2 1: HGB 2: HGB/HCT 3: HCT 2: Manual Cal. password has to be entered. Chapter 6. 2: Output SELECT Chapter 3. ........... INTRODUCTION .............................. 2-3 2............... 8.1 Display of Analysis Result.............................2-28 6...... 2-9 4...............................3 Output of Analysis Result to Host Computer........2-27 LIMITATIONS.............. 2-5 QUALITY CONTROL .... 2-3 2...........................................................2-30 STOPPING THE PNEUMATIC UNIT ...................October 1999 .................2 Limitation of Hemoglobin............... 2-2 START-UP PROCEDURE.. 6............... 2-1 1...2-24 5....................2 Printing of Analysis Result .................2-31 EXECUTION OF SHUTDOWN ...2-25 5..2-28 6......................2-29 EXPECTED RESULTS............ 4......... 7............................................................................................2 Analysis Procedure Flow Chart ...................................1 Overview of Analysis Modes.................................... 2-1 1.......2-16 DISPLAY AND PRINTING OF ANALYSIS RESULT ........................................... 2-9 4....2 Turning ON the Power and Self-Check .....CHAPTER 2 SAMPLE ANALYSIS 1.............................. Sysmex KX-21N Operator’s Manual -............................................ 2-8 PROCEDURES IN EACH ANALYSIS MODE .................2 Pre-Diluted (PD) Mode......................2-32 2.........1 Cell Count Parameters.. 5..........................................................................................2-24 5..................................................................................... 3................................2-32 9..............1 Shutdown Procedure ...................1 Whole Blood (WB) Mode.... 9.........................................2 Inspection before Turning ON the Power...... for instance. with the procedures in respective analysis modes. 1 . NOTE: • In the pre-diluted mode. Sysmex KX-21N Operator’s Manual -. The sample aspiration procedure is the same as in the whole blood mode. 1 Overview of Analysis Modes • • Whole blood mode This is the mode of analyzing collected blood sample in the whole blood status. blood sample diluted into 1:26 before analysis is used. and the output is confined to only the CBC8 parameter. This chapter describes the general operation procedures from instrument start-up to shutdown.SAMPLE ANALYSIS 1. collected from the earlobe or fingertip. INTRODUCTION This instrument works in two analysis modes: whole blood mode and pre-diluted mode. particle distribution curve and particle distribution analysis data are not output.October 1999 2-1 . In this mode. 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. 2 Analysis Procedure Flow Chart Shown below is the Flow Chart for the operation procedure with pages to refer to.SAMPLE ANALYSIS 1 .October 1999 . Inspection before Turning ON the Power Page 2-3 Turning ON the Power and Self-Check Page 2-5 Execution of Quality Control Page 2-8 Whole Blood Mode Analysis Page 2-9 Pre-Diluted Mode Analysis Page 2-16 Display and Printing of Analysis Result Page 2-24 Execution of Shutdown Page 2-32 Turning OFF the Power Table 2-1-1: Analysis Procedure Flow Chart 2-2 Sysmex KX-21N Operator’s Manual -. analysis cannot be resumed. • After unpacking. take care not to have dust adhere to the cubitainer spout kit. • If CELLPACK that has just arrived is used. • As to a reagent that may have frozen. take care to prevent entry of dust. Depending on the use conditions of the instrument.SAMPLE ANALYSIS 2. • When replacing the reagent container. CELLPACK STROMATOLYSER-WH 20 L 500 mL 60 days 90 days Table 2-2-1: Expiration After Opening the Seal Sysmex KX-21N Operator’s Manual -. the result may differ. When reagents run out during analysis. (For detail. If the number available is such as might become short during the day.30°C) for more than 24 hours. etc. Section 8: SUPPLIES REPLACEMENT. the instrument will automatically come to a stop. refer to Chapter 4.) Replenishing reagent • Make ready a new reagent and make sure that it has not passed its expiration date. Otherwise. START-UP PROCEDURE 2 . Until replenishment is completed. Inspection of reagents Check to see that the reagents needed for the number of the samples to be processed for the day are available.) • CAUTION • Use a reagent that has been left at room temperature (15 . 600 samples/20 L (cubitainer) STROMATOLYSER-WH: Approx. make ready the reagents for use in replenishment. which could impair proper analysis. "Background Error" may occur.October 1999 2-3 . there is a possibility that proper analysis cannot be performed. 470 samples/500 mL (bottle) (The above values are the result of continuous analyses performed in one day in the whole blood mode. Replenish the reagent that gave an error. handle it in accordance with the precautions stated on the Package Insert. make sure that its background count is low before starting sample analysis. 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. bacteria. 1 Inspection before Turning ON the Power 1. dirt. • After replenishing a reagent. October 1999 . reagent lot No.. discard the waste. 2-4 Sysmex KX-21N Operator’s Manual -. expiration date. Such paper can cause failure. 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. Avoid using print paper that has its end fixed to the core. name of reagent. Inspection of printer paper Open the front cover and check if printer paper needed for processing the samples for the day is available. 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). Such record would come handy. Figure 2-2-1: Inspection of Printer Paper (Built-in Printer) CAUTION: • Use the printer paper specified by Sysmex. 2. name of person who replenished. 4.SAMPLE ANALYSIS • We recommend preparing "Reagent Replenishment Record" in which to enter date of replenishment. The LCD screen displays "Please wait. 1. etc. and the "Ready" (ready for analysis) will appear. 2 Turning ON the Power and Self-Check Turn ON the power switch on the right side of the unit.SAMPLE ANALYSIS 2 ." during this period. The program version (Example: [0001]) appears at the right lower area of the screen. and background check will be automatically performed.October 1999 2-5 . Self-check. auto rinse. (1) Turn ON the power switch The initial display appears on the LCD screen. scheduled maintenance items. Sysmex KX-21N [00-01] Figure 2-2-2: Initial Display (2) Next. Figure 2-2-3: LCD Screen during Self-check Sysmex KX-21N Operator’s Manual -. Please wait. the instrument makes self-check of motor operation. 1 [g/dL] or less 10 [×103/µL] or less Sysmex KX-21N Operator’s Manual -. then turn it ON again. refer to Chapter 4: INSTRUMENT MAINTENANCE AND SUPPLIES REPLACEMENT. press [HELP] key to stop the alarm and display the Action Message screen.October 1999 2-6 . In accordance with the Action Message screen. contact Sysmex service representative. If the background count of any parameter exceeds tolerance after rinsing a maximum of 5 times. • To ensure optimum operation of the instrument. the message "Background Error" is displayed and the alarm sounds.) • Permissible background counts WBC RBC HGB PLT 0. In this case. then perform maintenance operation by following the instructions on the screen. an error message will appear on the LCD screen. auto rinse and background check are performed. turn OFF the power once. the counter is found exceeding the predetermined times. take an appropriate action. When the Scheduled Maintenance screen appears. If upon the power turn-on. service counters are provided for the components which require scheduled maintenance.3 [×103/µL] or less 0. For detail. If the error still occurs.02 [×106/µL] or less 0. *Auto Rinse* Please wait. the screen advising scheduled maintenance is displayed. (3) When self-check is normally completed.5 times. press [C] key to stop the alarm sound. (Refer to Chapter 7: TROUBLESHOOTING. Figure 2-2-4: LCD Screen during Auto Rinse NOTE: • Auto rinse is repeated 3 .SAMPLE ANALYSIS CAUTION: • When self-check reveals any error. In this case. 0 0.0 1:M.0 0.0 0.0 0. "0").0 0.0 0.0 0. is displayed "1.1 No.October 1999 2-7 . Confirming the "Ready" When auto rinse and background check are normally completed.0 0." Sysmex KX-21N Operator’s Manual -.0 0.0 0.Discri.0 0. The LCD screen displays the result of background check (sample No.0 WBC RBC HGB HCT MCV MCH MCHC PLT 0. the next sample No.0 0. 2:Output Figure 2-2-5: Ready Status NOTE: • When the power is on.0 0.SAMPLE ANALYSIS 2.0 0.0 0 Ready WB LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR 31/12 10:20 0. No.00 0.0 0. the buzzer (single beep) sounds briefly and "Ready" is displayed. Before starting sample analysis. For analysis procedure and examination of analysis result. refer to Chapter 5: QUALITY CONTROL. • Analysis mode to analyze a control blood Control blood is analyzed in the QC analysis mode. QUALITY CONTROL Quality control is of great importance for obtaining highly reliable data over a long period of time. 2-8 Sysmex KX-21N Operator’s Manual -.SAMPLE ANALYSIS 3. analyze control blood (EIGHTCHECK-3WP) using X control or L-J control program. as is the constant monitoring of the instrument for preventing troubles or for early detection of problems.October 1999 . The analysis mode used in analyzing control blood is described below. October 1999 2-9 . • When the reagent might have frozen. PROCEDURES IN EACH ANALYSIS MODE With this instrument. and tube setting are performed manually. is collected from the vein. handle it according to the precautions stated on the Package Insert of each reagent. Collecting and preparing samples A specified amount of sample. or EDTA-2Na. CAUTION • Some anticoagulants alter test results due to their effects on RBC hemolysis or platelet agglutination. improper analysis may result. cap removal. 1 Whole Blood (WB) Mode Samples are processed in the following steps: 1. Tubes up to 80 mm in height should be used. corresponding to the amount of EDTA anticoagulant. As anticoagulant. EDTA-3K. Sample analysis can be executed when the instrument is in the Ready status. sample mixing. Selecting whole blood mode 3. Otherwise. 4. Collecting and preparing samples 2. 4 . leave the blood taken from the refrigerator for 30 minutes until it equilibrated to room temperature. Inputting sample No. • In the case of refrigerated blood.SAMPLE ANALYSIS 4. use EDTA-2K. Analyzing samples 1. 50 µL Sysmex KX-21N Operator’s Manual -. The volume of sample that can be aspirated is as follows: Volume of sample aspirated Approx. NOTE: • The analysis mode selected here is maintained after completion of analysis. Figure 2-4-2: Selecting WB Mode (4) Press [ENTER] key to changeover the analysis mode and return to the Analysis screen. the system is in the whole blood mode. Press [ENTER] to Set. *Change Mode* Whole Blood(WB) Pre-Diluted(PD) (1) (2) Change mode with [ ]or[ ]. Press [MODE] key to display the Change Mode screen. 2-10 Sysmex KX-21N Operator’s Manual -.October 1999 . until it is switched to the other analysis mode." *Change Mode* Whole Blood(WB) Pre-Diluted(PD) Change mode with [ ]or[ ]. • At the time of turning-on the power. Selecting whole blood mode When the line on the side of the system status area on the LCD screen is " ". so change it over to the whole blood (WB) mode by the following procedure: Confirm the Ready status. Figure 2-4-1: Change Mode Screen (3) Press [ ] or [ ] key to select "Whole Blood (WB).SAMPLE ANALYSIS 2. Press [ENTER] to Set. the pre-diluted (PD) mode is in use for analysis. In the system status area on the LCD screen. Inputting sample No. press [C] key first. NOTE: • When entering the sample No. NOTE: • (1) Input from the panel keyboard Press [SAMPLE No. each time you press [C] key. turns to the reverse display and the system is waiting for Sample No. using the numeric keys. The sample No. • In the course of entering the sample No. 6) When one attempts to make analysis with the sample No. 3) Data is not transferred to the host computer.123456789012345 Not Ready Figure 2-4-3: Waiting for Sample No. This will clear the entire sample No. • A sample No. Input sample No. "0" (zero) is treated as a special sample number. of "0" (zero).October 1999 2-11 . input (2) The cursor appears under sample No. (on the screen of the previous page). is not incremented. No. can be used. 2) Analysis data is not stored. comprising numerics and a hyphen. 5) Judgment on abnormal histogram is not made. of a maximum of 15 digits. 5 Press [5] key on the numeric keys. Then. the next sample No. the buzzer sounds during sample aspiration. can be input by the following two methods. 4) Sample No. one character disappears with the cursor moving to the left. [Example] Input of sample No. Input the sample number when changing. • Input from the panel keyboard • Input using the handy barcode reader (option) • The sample number is set by the incremented value for each analysis. CAUTION: • Sample No. Sysmex KX-21N Operator’s Manual -. input (in the "Not Ready" status).. enter a new sample No.] key in the Ready status. 1) Judgement on patient limit is not made for analysis data.SAMPLE ANALYSIS 3. an alarm sounds.] key in the Ready status. (3) Press [ENTER] key. NOTE: • When all sample Nos. When you attempt to do so. This will fix the sample No. input ("Not Ready"). • (1) Input using the handy barcode reader (option) Press [SAMPLE No. the next sample No. ready for analysis.] or [SELECT] key. press [SAMPLE No.] or [SELECT] key. 2-12 Sysmex KX-21N Operator’s Manual -. input ("Not Ready"). turns to the reverse display and the system is waiting for Sample No. and the status becomes Ready. No. In the system status area on the LCD screen. the read sample number will appear. namely. press [SAMPLE No. This will fix the sample No. ready for analysis.October 1999 . [ENTER] key is not accepted. input (2) Read the barcode affixed to the test tube with the handy barcode reader.SAMPLE ANALYSIS (3) Press [ENTER] key. The screen returns to the Analysis screen without updating sample No. and the status becomes Ready.123456789012345 Not Ready Figure 2-4-4: Waiting for Sample No. • In the status of waiting for sample No. are cleared. namely. input (in the "Not Ready" status). The screen returns to the Analysis screen without updating sample No. NOTE: • In the status of waiting for sample No. Figure 2-4-5: Reading the Barcode When reading has been carried out normally. etc. (1) Mix the sample sufficiently.October 1999 2-13 . Figure 2-4-7: Removing the Plug (3) Set the tube to the sample probe. Start Switch Figure 2-4-8: Pressing the Start Switch Sysmex KX-21N Operator’s Manual -. Figure 2-4-6: Mixing the Sample (2) Remove the plug while taking care not to allow blood scatter. and in that condition. always wear rubber gloves. infection of bacteria can occur.. Analyzing samples • When analyzing samples. After WARNING completion of work. If your hands are contaminated by blood. press the start switch.SAMPLE ANALYSIS 4. wash hands with disinfectant. By that time. lower it straight down.SAMPLE ANALYSIS (4) The buzzer sounds two times . NOTE: • The sample probe is automatically rinsed. remove the tube. The screens from the start to the end of analysis are as shown in the following: (Ready) No.123456789-12345 Analyzing (Rinsing) No. Take care not to bend the sample probe. the rinse cup lowers. correct analysis result may not be obtained. 2-14 Sysmex KX-21N Operator’s Manual -.and when the LCD screen displays "Analyzing." remove the tube.123456789-12345 Rinsing (Ready) No.123456789-12346 Ready Figure 2-4-9: LCD Screen (in WB Mode) • While the LCD screen is displaying "Aspirating. beep" . After that. the unit executes automatic analysis and displays the result on the LCD screen. so there is no need to wipe it clean.123456789-12345 Aspirating (Analyzing) No. If the tube is removed during its display." keep holding the tube in the aforementioned status. • To remove the tube."beep. CAUTION CAUTION: • Several seconds after the buzzer sounds "beep. becoming ready for analysis of the next samples. Then the unit turns to the Ready status.123456789-12345 Ready (Aspirating) No. beep" and "Aspirating" appears on the LCD screen.October 1999 . although "0" (zero) is not incremented." prepare the next samples and repeat the procedure (1) to (4). if not changed. is automatically incremented by 1.October 1999 2-15 . • Sample No.SAMPLE ANALYSIS (5) When the LCD screen displays "Ready. [Example] 123 → 124 999999999999999 → 1 12-3 → 12-4 12-999 → 12-000 NOTE: Sysmex KX-21N Operator’s Manual -.. 20 µL or more Approx. 3. Collecting and preparing samples Preparing analysis samples in PD mode (dilution of 1:26) Selecting Pre-Diluted mode Inputting sample No. 2. use EDTA2K. If possible. blood cell count is generally higher than normal. 200 µL 2-16 Sysmex KX-21N Operator’s Manual -. Samples are processed by the following steps: 1. • A capillary blood collected from the earlobe or fingertip is prone to platelet agglutination. CAUTION Tubes up to 80 mm in height should be used. The volume of sample is as follows: Volume of whole blood required Volume of sample aspirated Approx. When the blood collection tube containing a commercial anticoagulant is used. with a consequent change in analysis result. As anti-coagulant. A correct result might not be obtained if analyzing after 30 minutes are passed. with lower reproducibility. • With a sample of blood collected from the earlobe or fingertip. EDTA-3K.October 1999 . 5.SAMPLE ANALYSIS 4 . 4. Analyzing samples 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. a sample is diluted into 1:26 before analysis. so dilute and analyze it within 30 minutes. 2 Pre-Diluted (PD) Mode In this mode. or EDTA-2Na. analyze the same diluted sample twice and compare the results. 1. there is a possibility that RBC hemolysis or platelet agglutination occurs depending on the types of anticoagulant. This mode is applied in analyzing a capillary blood collected from the earlobe or fingertip. (1) (2) (3) (4) (5) Preparing analysis samples in PD mode (1:26 Dilution) Clean a container such as erlenmeyer flask.. dispense 500 µL of CELLPACK into a micro-tube. collect 20 µL of blood and dispense it into the micro-tube. So. Using a syringe. CAUTION • A 1:26 dilution sample is prone to platelet agglutination.October 1999 2-17 . Using a capillary tube. take CELLPACK into a cleaned container. beaker.. Attach the cap and mix well.SAMPLE ANALYSIS 2. etc. wash hands with disinfectant. etc. with CELLPACK and remove any dirt. Using a 500 µL transfer pipette. Therefore prepare one sample at a time. infection of bacteria or the like can occur. etc. use the tools listed below: • Diluent (CELLPACK) • Micro-tube (MT-40.. analyze the sample within 30 minutes after blood dispensing and diluting.) • Capillary tube • A 500 µL transfer pipette • A container. • When preparing PD-mode analysis samples. If diluent is dispensed in advance. such as erlenmeyer flask or beaker • A syringe Sysmex KX-21N Operator’s Manual -. etc. When preparing a 1:26 dilution sample. After completion of work. always wear rubber gloves. evaporation and dirt mixing will result in errors in analysis values. etc. If WARNING your hands are contaminated by blood. Figure 2-4-10: Change Mode Screen (3) Press [ ] or [ ] key to select "Pre-Diluted (PD). Figure 2-4-11: Selecting PD Mode (4) Press [ENTER] key to changeover the analysis mode and return to the Analysis screen. Press [ENTER] to Set. the system is in the whole blood mode. the whole blood (WB) mode is in use for analysis. • At the time of turning-on the power. Press [ENTER] to Set. *Change Mode* Whole Blood(WB) Pre-Diluted(PD) (1) (2) Change mode with [ ]or[ ]. so change it over to the pre-diluted (PD) mode by the following procedure: Confirm the Ready status. Press [MODE] key to display the Change Mode screen." *Change Mode* Whole Blood(WB) Pre-Diluted(PD) Change mode with [ ]or[ ]. Selecting Pre-Diluted mode When the line on the side of the system status area on the LCD screen is " ".October 1999 .SAMPLE ANALYSIS 3. until it is switched to the other analysis mode. • The analysis mode selected here is maintained after completion of analysis. NOTE: 2-18 Sysmex KX-21N Operator’s Manual -. The next Sample No. Then. in the system status area on the LCD screen turns to the reverse display and the system waits for Sample No.. NOTE: • (1) Input from the panel keyboard Press [SAMPLE No. of a maximum of 15 digits. is not incremented. 3) Data is not transferred to the host computer. No. press [C] key first.SAMPLE ANALYSIS 4. The sample No. 5) Judgment on abnormal histogram is not made. 4) Sample No. CAUTION: • Sample No. enter a new sample No. 1) Judgement on patient limit is not made for analysis data. the buzzer sounds during sample aspiration. Input sample No. NOTE: • When entering the sample No. can be used.October 1999 2-19 . comprising numerics and a hyphen. can be input by the following two methods. (on the screen of the previous page). Inputting sample No. "0" (zero) is treated as a special sample number. each time you press [C] key. 6) When one attempts to make analysis with the sample No. • A sample No.123456789012345 Not Ready Figure 2-4-12: Waiting for Sample No. one character disappears with the cursor moving to the left. • Input from the panel keyboard • Input using the handy barcode reader (option) • The sample number is set by the incremented value for each analysis. Sysmex KX-21N Operator’s Manual -. • In the course of entering the sample No. 2) Analysis data is not stored. input (in the "Not Ready" status).] key in the Ready status. This will clear the entire sample No. 5 Press [5] key on the numeric keys. [Example] Input of Sample No. Input the sample number when changing. of "0" (zero). using the numeric keys. input (2) The cursor appears under sample No. are cleared. The screen returns to the Analysis screen without updating sample No. (3) Press [ENTER] key. NOTE: • (1) Input using the handy barcode reader (option) Press [SAMPLE No. an alarm sounds.] or [SELECT] key. and the status becomes Ready. [ENTER] key is not accepted. ready for analysis. In the system status area on the LCD screen. input (in the "Not Ready" status). input (2) Read the barcode affixed to the test tube with the handy barcode reader. press [SAMPLE No. This will fix the sample No. the read sample number will appear. • In the status of waiting for sample No. The screen returns to the Analysis screen without updating sample No. 2-20 Sysmex KX-21N Operator’s Manual -. Figure 2-4-14: Reading the Barcode When reading has been carried out normally.123456789012345 Not Ready Figure 2-4-13: Waiting for Sample No. namely. the next sample No. When you attempt to do so.October 1999 . turns to the reverse display and the system is waiting for Sample No.] or [SELECT] key. NOTE: • In the status of waiting for sample No. No. This will fix the sample No.SAMPLE ANALYSIS (3) Press [ENTER] key. input ("Not Ready"). input ("Not Ready"). • When all sample Nos.] key in the Ready status. press [SAMPLE No. ready for analysis. and the status becomes Ready. namely. press the start switch. wash hands with disinfectant. Start Switch Figure 2-4-17: Pressing the Start Switch Sysmex KX-21N Operator’s Manual -.October 1999 2-21 . and in that condition. Figure 2-4-15: Mixing the Sample (2) Remove the plug while taking care not to allow blood scatter. always wear rubber gloves. etc. infection of bacteria can occur. Analyzing samples • When analyzing samples.SAMPLE ANALYSIS 5.. WARNING (1) Mix the sample sufficiently. and after completion of work. Figure 2-4-16: Removing the Plug (3) Set the micro-tube to the sample probe. If your hands are contaminated by blood. 123456789-12345 Rinsing (Ready) No.and when the LCD screen displays "Analyzing. Take care not to bend the sample probe.October 1999 . beep" ." keep holding the micro-tube in the aforementioned status.123456789-12345 Aspirating (Analyzing) No. CAUTION CAUTION: • Several seconds after the buzzer sounds "beep. beep" and "Aspirating" appears on the LCD screen. By that time. Then the unit turns to the Ready status.123456789-12345 Analyzing (Rinsing) No. The screens from the start to the end of analysis are as shown in the following: (Ready) No. • To remove the micro-tube. lower it straight down. correct analysis result may not be obtained. becoming ready for analysis of the next samples. remove the micro-tube.123456789-12345 Ready (Aspirating) No. If the micro-tube is removed during its display.123456789-12346 Ready Figure 2-4-18: LCD Screen (in PD Mode) • While the LCD screen is displaying "Aspirating. so there is no need to wipe it clean. After that. the unit executes automatic analysis and displays the result on the LCD screen. 2-22 Sysmex KX-21N Operator’s Manual -. NOTE: • The sample probe is automatically rinsed. the rinse cup lowers." remove the micro-tube."beep.SAMPLE ANALYSIS (4) The buzzer sounds two times . • Sample No. is automatically incremented by 1.. if not changed. [Example] 123 → 124 999999999999999 → 1 12-3 → 12-4 12-999 → 12-000 NOTE: Sysmex KX-21N Operator’s Manual -." prepare a next sample and repeat the procedure (1) to (4). although "0" (zero) is not incremented.October 1999 2-23 .SAMPLE ANALYSIS (5) When the LCD screen displays "Ready. 25.7.123456789-12345 WB LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR 31.82.Discri.4 3.3 .8 .5 .Discri.9 9.5 % % % fL % fL fL 2. Calculation Parameter & Particle Distribution Display Screen No.97 14.9 9.1 3. CBC8 Parameter & Particle Distribution Display Screen No.1: Display of Analysis Result.Discri.6 20. Examples of display (For the Whole Blood mode) P1.0 pg + 44.123456789-12346 Ready No.6 49.0 pg + 44.123456789-12346 Ready No.8 g/dL 03/µL 180 ×1 3 31/12 10:59 WBC RBC PLT 1:M.5 % % % fL % fL fL % P4. and pages are turned over by using [ ] or [ ] key.4 3.5 % 1:M.6 20.123456789-12345 WB LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR 31.82.2 1.2 19.7 32.Discri. 2:Output P3.7 g/dL 32.8 % . refer to Chapter 3.5 31/12 10:59 1:M.3 .97 ×1 06/µL 14.82. 2:Output 1:M.5 31/12 10:59 WBC RBC PLT 31/12 10:59 2.6 fL 37.Discri.25.SAMPLE ANALYSIS 5. CBC8 Parameter & Patient Limit Graph Display Screen No.9. For the contents of display. The display screen of analysis result consists of five pages.25.2 . 1 Display of Analysis Result The result of each analysis is displayed on the LCD screen.123456789-12346 Ready No.5 2.2 .123456789-12345 WB WBC RBC HGB HCT MCV MCH MCHC PLT 7.8 g/dL 03/µL 180 ×1 3 31/12 10:59 31.2 1.8 180 LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR P2.6 49. 2:Output 1:M. All Analysis Data Display Screen No.2 19.9.123456789-12345 WB WBC RBC HGB HCT MCV MCH MCHC PLT 7.6 37.97 ×1 06/µL 14.3 .8 % .6 49.October 1999 . Section 2.9.7.2 19.123456789-12346 Ready No.5 . 2:Output P5. 2:Output Figure 2-5-1: Analysis Result Display Screen 2-24 Sysmex KX-21N Operator’s Manual -.6 20.9 9.6 fL 37. Calculation Parameter & Patient Limit Graph Display Screen No.0 + 44.1 ×1 0 /µL 3. DISPLAY AND PRINTING OF ANALYSIS RESULT 5 .5 .7 g/dL 32.2 1.7.4 3.2 .1 ×1 3.123456789-12346 Ready No.123456789-12345 WB WBC RBC HGB HCT MCV MCH MCHC PLT 0 /µL 7. 9 206 27. 2.9 206 ×1 03/µL ×1 06/µL g/dL % fL Pg g/dL ×1 03/µL [fL] LYM% MXD% NEUT% LYM# MXD# NEUT# 27.2 80.4 2.3 fL 15.9 206 ×1 03/µL ×1 06/µL g/dL % fL Pg g/dL ×1 03/µL WBC WBC RBC HGB HCT MCV MCH MCHC PLT LYM% MXD% NEUT% LYM# MXD# NEUT# RDW-SD RDW-CV PDW MPV P-LCR 7.0 % PLT [fL] PDW MPV P-LCR 8.1 14.8 36.2 13.52 14. (The external printer is an option) For the contents of the print and the printing procedure.7 40.3 9. Examples of printing with the Built-in Printer [Type 1] No. and 3.3 % % % ×1 03/µL ×1 03/µL ×1 03/µL RBC [fL] RDW-SD RDW-CV 8.1 32. Sysmex KX-21N Operator’s Manual -. 123456789-12345 Date 31/10/1999 Time 10:02 Mode WB [W][R][P] [Type 2] No.4 59.1 32.3 4.4 2. For the selecting procedure.1 32.3 fL 9.3 4.2 80.8 36. 123456789-12345 Date 31/10/1999 Time 10:02 Mode WB [W][R][P] [Type 3] No.4 59. refer to Chapter 10.October 1999 2-25 . Section 7.SAMPLE ANALYSIS 5 .8 ×1 03/µL ×1 06/µL g/dL % fL Pg g/dL ×1 03/µL % % % ×1 03/µL ×1 03/µL ×1 03/µL fL % fL fL % WBC RBC HGB HCT MCV MCH MCHC PLT 7. refer to Chapter 3.8 % Figure 2-5-2: Printing of Analysis Result (Built-in Printer) NOTE: • One print format can be selected from among Types 1.52 14.3 4.8 36.7 40.1 fL 14.0 1.0 4.3 15.0 8.3: External Output. Section 2.0 4. 123456789-12345 Date 31/10/1999 Time 10:02 Mode WB [W][R][P] WBC RBC HGB HCT MCV MCH MCHC PLT 7.2 13.0 1.3: IP Output Settings.3 8.2 80.7 40. 2 Printing of Analysis Result Analysis result can be printed out on the built-in or the external printer.52 14. 52 [×1 14.4 [%] 03/µL] 2.3 [×1 8.0 [×1 03/µL] 1.9 [g/dL] 03/µL] 206 [×1 27.0 [×1 03/µL] 4.8 [%] PLT RBC WBC 31/10/1999 16:40 Manual Ana:[W][R][P] Figure 2-5-3: Printing of Analysis Result (Graphic Printer) 2-26 Sysmex KX-21N Operator’s Manual -.3 [fL] 15.2 [%] 80.2 [%] 13.:123456789-12345 Mode:WB [ERROR] WBC RBC HGB HCT MCV MCH MCHC PLT LYM% MXD% NEUT% LYM# MXD# NEUT# RDW-SD RDW-CV PDW MPV P-LCR 03/µL] 7.1 [fL] 32.SAMPLE ANALYSIS Examples of printing with the Graphic Printer Sample No.1 [fL] 14.3 [fL] 9.4 [%] 59.0 [%] 8.7 [Pg] 40.October 1999 .3 [×1 06/µL] 4.8 [g/dL] 36. Sysmex KX-21N Operator’s Manual -.3 18. Width Mean Platelet Vol PLT-Large Cell Ratio PRINT TICKET No.1 32.0 14.0 68. 3 Output of Analysis Result to Host Computer The analysis result can be output to the host computer. Width-CV PDW MPV P-LCR PLT Distrib. For the output procedure to the host computer.9 206 ×10 3/µL ×10 6/µL Data Sample No.5 10. Section 2.SAMPLE ANALYSIS Examples of printing with the Data Printer HEMATOLOGY Carte No.58 8.0 3.6 1.0 34.3: External Output.7 40.9 1.5 10.October 1999 2-27 .6+ 3.1 80. Name Doctor Age M F 10/12/1999 123456789012345 5. refer to Chapter 3.8 52.7 W-SCR % % % WBC RBC g/dL % fL W-MCR W-LCR W-SCC ×10 3/µL ×10 3/µL ×10 3/µL fL fL fL HGB HCT MCV MCH pg W-MCC W-LCC RDW-SD PDW MPV P-LCR % MCHC g/dL ×10 3/µL PLT Retic Myeloblast Pro Neutro Myelo Meta Stab Seg Eosino Baso Mono Lymph W-SCR WBC-Small Cell Ratio 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. 28.22 Figure 2-5-4: Printing of Analysis Result (Data Printer) 5 . CAUTION: • WBC results may be elevated erroneously due to unlysed red cells in patients with hemoglobinopathies. red cell clumping on smear Elevation of WBC Elevation of WBC ↑MCHC.000/µL) HGB Leukocytosis (>100. Parameter Specimen WBC Cold Agglutinin Platelet aggregation Erythroblastosis Nucleated RBC Cryoglobulins RBC Cold Agglutinin Severe Microcytosis Fragmented RBC Leukocytosis (>100. (?): Instrument count is affected by either an increase or decrease in the result which is sample dependent.000/µL) Abnormal Red Cell Fragility Spherocytosis Pseudothrombocytopenia Platelet Aggregation Increased Microcytosis Megalocytic Platelets Error (+) (+) (+) (+) (+) (-) (-) (-) (+) (+) (+) (+) (-) (+) (?) (?) (-) (-) (+) (-) Possible Indication of Error ↑MCV. The following table shows examples of specific specimens that could cause errors. (-): Instrument count is affected by a decrease in the result. red cell clumping on smear Elevation of WBC ↓MCV. ↓HCT. 2-28 Sysmex KX-21N Operator’s Manual -. “milky” appearance of plasma ↑MCHC. red cell clumping on smear Platelet aggregates on smear Erythroblasts on smear NRBC on smear ↑MCV. LIMITATIONS 6 . ↓HCT. Lysed Hgb/WBC sample turns cloudy ↑MCV. 1 Cell Count Parameters Some abnormal samples may give incorrect results by automated cell counting methods. ↓HCT.SAMPLE ANALYSIS 6.October 1999 .000/µL) Lipemia Abnormal Protein HCT Cold Agglutinin Leukocytosis (>100. severe liver disease or in neonates. spherocytes on smear Platelet Satellitism on smear Platelet Aggregation on smear ↓MCV PLT (+): Instrument count is affected by an increase in the result. The hemoglobin method available for this analyzer cannot detect sulfhemoglobin. 3. Performance specifications for hemoglobin results are assured only when instrument environment and sample requirements are observed.000/µL.SAMPLE ANALYSIS 6 . The affect of lipemia and abnormal proteins may be removed by plasma replacement or plasma blank procedures. 2. verdohemoglobin choleglobin or other unusual degradation products of hemoglobin. Hemoglobin measurements may be falsely elevated due to the influences of abnormal samples including leukocytosis above 100. Sysmex KX-21N Operator’s Manual -. 2 Limitation of Hemoglobin 1. lipemia or abnormal proteins in blood plasma.October 1999 2-29 . 47.9 . fluid intake.8 1.2 .6 30. Villanova.4 10.9 9.8 .1 .8.3 134 .5 .1 8.7 35.3 78.9 33.4 31.14.9 1.3 11. diet. Hemoglobin.7 0.4. MCV. Sysmex recommends that each laboratory establish its own expected reference intervals based upon the laboratory’s patient population encountered during daily operation.3 .77.6 .5. 1 NCCLS.4 .4.8 3. Mxd% and #.1.0 8.7 .6.October 1999 2-30 .2 9. Parameter WBC RBC Hgb Hct MCV MCH MCHC Plt Lym% Mxd% Neut% Lym# Mxd# Neut# RDW-CV RDW-SD PDW MPV P-LCR Range for Females n=117 3. The NCCLS Document C28A1.66 years with a mean age of 33. Hematocrit.1 .24.7 32.2. Platelet. RDW-SD.42. etc.6 .4 128 .10. MCHC.5 .34. “How to Define and Determine Reference Intervals in the Clinical Laboratory.36.1 0. • The age range for males was 17 .2 25. and Neut% and # were determined and displayed in Table 1-16-1.6 1.3 . MCH.2.9 .5 1.69 0.18.6 9. This document contains guidelines for determining reference values and intervals for quantitative clinical laboratory test. USA.3 .3 10.6 .4 14.6 . P-LCR*.35.72 years with a mean age of 42.34. RDW-CV.1 . geographic location.8 . Lym% and #.103. PDW*.SAMPLE ANALYSIS 7.2 . age. * For Investigational Use Only in the United States of America.44 Range for Males n=124 2.377 17. Expected reference intervals may vary due to differences in sex.18.9 43.3 .8 .2 .434 15 .15. Not a reportable parameter.25.5.48.15.8 .47.0 Table 2-7-1: Normal Population Reference Ranges NOTE: • The age range for females was 17 .5 80.7 31.7 .3 . The ranges for each parameter --.1. Approved Guideline”. PA 19085.3 3.8 0.12.2 .4 . MPV.102.2.1 .3 .6 38.6 . EXPECTED RESULTS Reference intervals (normal population reference ranges) were developed for the KX-21N using normal individuals.WBC. Sysmex KX-21N Operator’s Manual -.45.45.9 -13.12.6 .3 . 771 East Lancaster Avenue.49.4 26 .9 10. RBC. " *SELECT* 1:Stored Data 2:Quality Control 3:Calibration 4:Replace Lyse 5:Auto Rinse 6:Settings 7:Maintenance 8:Periph. It is also possible to manually stop the pneumatic unit using the following procedures: (1) (2) Press [SELECT] key in the Ready status. NOTE: Sysmex KX-21N Operator’s Manual -. STOPPING THE PNEUMATIC UNIT The KX-21N.October 1999 2-31 . when left non-operating for 15 minutes. The Select Menu screen appears. automatically stops the pneumatic unit. Settings 00:PU Sleep Figure 2-8-1: Select Menu Screen (3) Press [ENTER] key. Using [ ] key or [ ] key. move the cursor to select "00: PU Sleep.SAMPLE ANALYSIS 8. • Press the start switch to return to the ready status. This stops the pneumatic unit. By executing shutdown.October 1999 . failures could occur. shutdown is canceled and the Analysis screen returns. CAUTION: • If the power is turned OFF before executing shutdown. 5 minutes. Execute shutdown after the day's work is finished.SAMPLE ANALYSIS 9. 2-32 Sysmex KX-21N Operator’s Manual -. EXECUTION OF SHUTDOWN When analyses of all samples are finished. execute shutdown before turning the power off. 1 Shutdown Procedure (1) Press [SHUTDOWN] key in the Ready status. such as fluid dripping from the rinse cup and crystals forming around the rinse cup. 9 . *Shutdown* Ready Aspirate CELLCLEAN. shut it down at least once in 24 hours. the TD chamber and diluted sample line are cleaned. 3:Cancel Figure 2-9-1: Shutdown Screen NOTE: • When [3] key is pressed. The Shutdown screen appears. and also when this instrument is used continuously. It will take approx. take care not to have it adhere to the skin or clothes. If the skin or clothes should come in touch with it. Take care not to bend the sample probe. keep holding CELLCLEAN in the same status. set CELLCLEAN to the sample probe and press the start switch in that status.beep. While "Aspirating" is being displayed on the screen. After that.October 1999 2-33 . informing the completion of aspiration. Start Switch Figure 2-9-2: Pressing the Start Switch • Because CELLCLEAN is a strong alkaline detergent. *Shutdown* Rinsing Please wait. lower it straight down.. Otherwise. it can damage the skin or clothes.SAMPLE ANALYSIS (2) When executing shutdown. it cannot be canceled until it is completed. flush it away using plenty of water. remove CELLCLEAN from the sample probe. Sysmex KX-21N Operator’s Manual -. shutdown is executed automatically. Figure 2-9-3: Shutdown Execution Screen CAUTION: • To remove CELLCLEAN. beep. (3) When the buzzer sounds two times . WARNING NOTE: • Once shutdown is executed. • When the [1] key is pressed. the unit will restart. Turn OFF the power. turn off the power switch on the right side of the unit.SAMPLE ANALYSIS (4) When shutdown is finished and the following message is displayed. 2-34 Sysmex KX-21N Operator’s Manual -. 1:Re-boot Figure 2-9-4: Shutdown Completion Message Screen NOTE: • Shutdown will take approximately 5 minutes.October 1999 . *Shutdown* Shut-down sequence was completed. ..... 2.......... 3-7 2......... 3-1 PROCESSING LATEST SAMPLES ... INTRODUCTION ............................................1 Executing and Quitting Stored Data Processing Program .......................... 3-2 2..................CHAPTER 3 DISPLAY AND PROCESSING OF ANALYSIS RESULTS 1..................................... 3-2 2..................... 3......... Sysmex KX-21N Operator’s Manual -..............2 Stored Data Screen..........1 Display of Analysis Result.....................................2 Manual Discrimination...................................5 Correcting a Sample Number.....October 1999 ............................................. 3..................... 3..................3 External Output....................................... 3-14 3-14 3-15 3-20 3-21 3-23 3..................... 3.......................... 3-11 PROCESSING STORED DATA ..........3 Deletion..................................................................... 3..................4 External Output..................... and output to external devices. INTRODUCTION This instrument displays analysis result and information that assists in breaking down analysis result and outputs such data to external devices. and how to process them are explained here. Sysmex KX-21N Operator’s Manual -. what they mean. what they mean. Description is made on the display contents of stored data. Processing of Stored Data The analysis data stored in the instrument can be read at anytime. analysis result is displayed in three kinds of screens. The gist of the contents is as follows: Processing of Latest Samples When analysis is finished. The display contents of Analysis Result screen.October 1999 3-1 . such as displaying latest or stored data on the screen or outputting them to external devices.DISPLAY AND PROCESSING OF ANALYSIS RESULTS 1. This chapter describes the processing of analysis result. deletion by marking. 2:Output Menu Display Area Figure 3-2-2: All Analysis Data Display Screen 3-2 Sysmex KX-21N Operator’s Manual -.8 . When the analysis result is displayed.DISPLAY AND PROCESSING OF ANALYSIS RESULTS 2.5 .1 3.7. In the Analysis Result Display Area. Calculation Parameter & Particle Distribution Display Screen Figure 3-2-1: Page Selection in the Analysis Screen P1.4 3.123456789-12346 Ready No.0 + 44.9 9.9.123456789-12345 WB WBC RBC HGB HCT MCV MCH MCHC PLT 7.5 Date/Time Analyzed LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR Analysis Result Display Area 1:M." and "2: Output.6 20.October 1999 . All Analysis Data Display Screen No.3 . 1 Display of Analysis Result The analysis result is displayed in the Analysis Result Display Area on the LCD screen.6 37.82. Mode Indication 31/12 10:59 31.2 19. PROCESSING LATEST SAMPLES 2 . Discri. P1." Use [ ] key or [ ] key to change over pages.2 . The Analysis screen consists of five pages that differ from each other in "Analysis Result Display Area.5 2.97 14. Calculation Parameter & Patient Limit Graph Display Screen P5. the analysis result is displayed each time a new sample is analyzed.6 49.8 180 System Status Display Area Latest Sample No. the menu display area displays the menu of "1: M. All Analysis Data Display Screen P2. CBC8 Parameter & Patient Limit Graph Display Screen P3.25.2 1." which can each be executed using the numeric keys.7 32.Discri. CBC8 Parameter & Particle Distribution Display Screen P4. Mode Indication No. Calculation Parameter & Patient Limit Graph Display Screen NOTE: • When analysis is made in the pre-diluted mode.123456789-12345 WB LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR 31.9 9.25.2 19.123456789-12346 Ready No.7.6 49.123456789-12345 WB WBC RBC HGB HCT MCV MCH MCHC PLT 03/µL 7.5 31/12 10:59 Date/Time Analyzed Patient Limit Graph 1:M.-.3 .0 pg + 44.5 .. 2:Output Figure 3-2-3: CBC8 Parameter & Patient Limit Graph Display Screen P3.97 ×1 06/µL 14.Discri. 2:Output Figure 3-2-4: Calculation Parameter & Patient Limit Graph Display Screen Sysmex KX-21N Operator’s Manual -.October 1999 3-3 .6 20. -.82.7 g/dL 32.1 ×1 3.2 1.Discri." The particle distribution curve is not displayed.5 % % % fL % fL fL % 2. Mode Indication 31/12 10:59 Date/Time Analyzed Patient Limit Graph 1:M. Latest Sample No.6 fL 37. particle distribution analysis parameters are displayed in ".2 . CBC8 Parameter & Patient Limit Graph Display Screen No.8 g/dL 03/µL 180 ×1 Latest Sample No.DISPLAY AND PROCESSING OF ANALYSIS RESULTS P2.4 3.123456789-12346 Ready No.9.8 % . 0 pg + 44.97 ×1 14.2 .5 Latest Sample No.Discri. 2:Output Figure 3-2-5: Calculation Parameter & Particle Distribution Display Screen P5.October 1999 .123456789-12346 Ready No.2 1.4 3.6 fL 37.2 19.DISPLAY AND PROCESSING OF ANALYSIS RESULTS P4.5 . Mode Indication 31/12 10:59 WBC RBC PLT Date/Time Analyzed WBC Particle Distribution Chart RBC Particle Distribution Chart PLT Particle Distribution Chart 1:M. CBC8 Parameter & Particle Distribution Display Screen No.Discri.7 g/dL 32.8 % . Mode Indication 31/12 10:59 WBC RBC PLT Date/Time Analyzed WBC Particle Distribution Chart RBC Particle Distribution Chart PLT Particle Distribution Chart 1:M.6 20.3 .6 49.123456789-12345 WB WBC RBC HGB HCT MCV MCH MCHC PLT 03/µL 7.82.7.5 % % % fL % fL fL % 2.1 ×1 06/µL 3.8 g/dL 180 ×1 03/µL Latest Sample No.123456789-12345 WB LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR 31. Calculation Parameter & Particle Distribution Display Screen No. 2:Output Figure 3-2-6: CBC8 Parameter & Particle Distribution Display Screen 3-4 Sysmex KX-21N Operator’s Manual -.9.9 9.25.123456789-12346 Ready No. DISPLAY AND PROCESSING OF ANALYSIS RESULTS 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) 3) Latest Sample No. The latest sample No. is displayed. 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." Date/Time Analyzed Date and time when analysis result was obtained are displayed. Analysis Data The analysis data of the following 19 parameters or part of them are displayed depending on the screen: Analysis parameters (8): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT Calculation parameters (11): LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#, RDW-SD, RDW-CV, PDW, MPV, P-LCR The marks to the left of analysis data indicate the following: 1. ! : The data is out of the linearity limit. 2. + : The data exceeds the upper Mark Limits. - : The data exceeds the lower Mark Limits. 3. * : The data is low in reliability. 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. 4) 5) 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 -- October 1999 3-5 DISPLAY AND PROCESSING OF ANALYSIS RESULTS 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. Patient Limit Graph Synchronize with setting the Mark Limits value, and display whereabouts location of the analysis value for a standard range. Abnormal range Analysis value Abnormal range 7) Lower Mark Limit Upper Mark Limit Center Mark Limit Figure 3-2-7: Patient Limit Graph 8) 9) WBC Particle Distribution Chart The WBC Particle distribution chart is displayed. RBC Particle Distribution Chart The RBC Particle distribution chart is displayed. 1 0 ) PLT Particle Distribution Chart The PLT Particle distribution chart is displayed. 3-6 Sysmex KX-21N Operator’s Manual -- October 1999 DISPLAY AND PROCESSING OF ANALYSIS RESULTS 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:WBC 2:RBC 3:PLT 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) *M.Discri.* No.123456789-12345 WBC WB WBC LYM% MXD% NEUT% LYM# MXD# NEUT# 31/12 10:59 7.1×1 03/µL 31.2% 19.6% 49.2% - 2.0×1 03/µL 1.4×1 03/µL 03/µL 3.5×1 LD 30 fL T1 90 fL T2 144 fL [ ][ ] for item, [ ][ ] for cursor Figure 3-2-9: M. Discri. Screen (WBC) Sysmex KX-21N Operator’s Manual -- October 1999 3-7 DISPLAY AND PROCESSING OF ANALYSIS RESULTS M. Discri. Screen (RBC) *M.Discri.* No.123456789-12345 RBC WB RBC HGB HCT MCV MCH MCHC RDW 31/12 10:59 3.97×1 06/µL 14.7g/dL 32.8% - 82.6fL 37.0pg + 44.8g/dL - 25.6fL LD 25 fL UD 250 fL [ ][ ] for item, [ ][ ] for cursor Figure 3-2-10: M. Discri. Screen (RBC) M. Discri. Screen (PLT) *M.Discri.* No.123456789-12345 PLT WB PLT PDW MPV P-LCR 2 fL 30 fL 31/12 10:59 180×1 03/µL 7.9fL 9.3fL 9.5% LD UD [ ][ ] 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. 3-8 Sysmex KX-21N Operator’s Manual -- October 1999 DISPLAY AND PROCESSING OF ANALYSIS RESULTS (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 LD T1 T2 Lower Limit 6 fL (0ch) LD T1 Upper Limit T1 T2 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 LD UD Lower Limit 5 fL (0ch) LD Upper Limit UD 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 LD UD Lower Limit 1 fL (0ch) LD Upper Limit UD 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. When you want to change another Discri., repeat the above (2) - (6) operation. (6) Sysmex KX-21N Operator’s Manual -- October 1999 3-9 DISPLAY AND PROCESSING OF ANALYSIS RESULTS (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. When you update the contents, analysis values changed in M. Discri. on the Analysis screen are reverse-displayed. No.123456789-12346 Ready No.123456789-12345 WB WBC RBC HGB HCT MCV MCH MCHC PLT 7.1 39.7 14.7 32.8 - 82.6 37.0 + 44.8 180 LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR (9) 31/12 10:59 31.2 19.6 49.2 - 25.6 20.5 - 7.9 9.3 - 9.5 2.2 1.4 3.5 1:M.Discri. 2:Output Figure 3-2-13: Analysis Screen 3-10 Sysmex KX-21N Operator’s Manual -- October 1999 (The external printer is an option) Printing to Printer (1) Press [2] key on the Analysis screen and select "2: Output.3: IP Output Settings. Refer to "Output to Host Computer" described later. 1:Host 2:DP 3:GP 4:LP 5:IP 6:IP Feed 7:Cancel Figure 3-2-14: Pop-up Menu (2) Using [ ] key or [ ] key to move the cursor to the desired printer. and press [ENTER] key. [6:IP Feed]: Carries out the paper feed of the built-in printer.2: Printing of Analysis Result. [7: Cancel]: This cannot be selected. 3 External Output This menu can be used to print out the latest sample's analysis result from the builtin/external printer or output to the host computer.DISPLAY AND PROCESSING OF ANALYSIS RESULTS 2 . [2: DP]: The data printer starts printing the analysis result of the latest sample. Sysmex KX-21N Operator’s Manual -.80 ×1 06/µL Sample No. refer to Chapter 10. Date Time Mode WBC RBC 123456789-12345 31/10/1999 10:02 WB [W][R][P] WL+ 11. Section 7. Section 5. Contents of Printing Contents of print with built-in printer No. Date Analyzed Time Analyzed Parameter Discriminated Manually Mode Indication Figure 3-2-15: Printing of Analysis Result (Built-in Printer) NOTE: • For printing format of built-in printer. [1: Host]: Output the data to the host computer.3 ×1 03/µL 3. [3: GP]: The graphic printer starts graphic printing the analysis result of the latest sample. [5: IP]: The built-in printer starts printing the analysis result of the latest sample. [4: LP]: This cannot be selected.October 1999 3-11 . refer to Chapter 2." The pop-up menu to select the output destination will appear. To change the printing format. " 3-12 Sysmex KX-21N Operator’s Manual -.2 [%] 80.3 [×1 06/µL] 4.8 [g/dL] 36. 28.58 8.0 W-SCR % % % WBC RBC g/dL % fL W-MCR W-LCR W-SCC ×10 3/µL ×10 3/µL ×10 3/µL fL HGB HCT MCV MCH pg W-MCC W-LCC RDW-CV MCHC g/dL Figure 3-2-17: Analysis Result List Print (Data Printer) 1) 2) Sample No.9 [g/dL] WBC Parameter Discriminated Manually Time Analyzed Date Analyzed 31/10/1999 16:40 Manual Ana:[W][R][P] Figure 3-2-16: Analysis Result Graphic Print (Graphic Printer) Contents of print with data printer HEMATOLOGY Carte No. Mode Indication The mode in which sample was analyzed is printed.6 1.3 18.October 1999 .9 1.0 3.6+ 3.7 ×10 3/µL ×10 6/µL Data Sample No. Name Doctor Age M F Date Analyzed Sample No. is printed.7 [Pg] 40. 10/12/1999 123456789012345 5.1 32.52 [×1 14.DISPLAY AND PROCESSING OF ANALYSIS RESULTS Contents of print with graphic printer Mode Indication Sample No.1 80.8 52. The whole blood mode is printed as "WB" and the pre-diluted mode as "PD.:123456789-12345 Mode:WB [ERROR] WBC RBC HGB HCT MCV MCH MCHC 03/µL] 7.0 34.1 [fL] 32. The latest sample No. Sample No. Output to Host Computer (1) Press [2] key on the Analysis screen and select "2: Output.DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3) 4) Date/Time Analyzed Date and time when analysis result was obtained are printed. and press [ENTER] key. Parameter Discriminated Manually When M.October 1999 3-13 ." The pop-up menu to select the output destination will appear. (2) Using [ ] key or [ ] key to move the cursor to [1: Host]. Discri is used. Output the analysis data of the latest sample to the host computer. the parameter discriminated manually are printed. Sysmex KX-21N Operator’s Manual -. and analysis mode on the Analysis screen return to the status before the execution of the stored data processing program." Press [ENTER] key. 3-14 Sysmex KX-21N Operator’s Manual -. the oldest data are automatically deleted. move the cursor to select "1: Stored Data.123456789-12345 [ENTER] to mark. The Stored Data screen [1/7] appears. 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. 31/12 10:59 [1/7] 3:Chg. NOTE: • The sample No. 1 Executing and Quitting Stored Data Processing Program Executing the Program (1) Press [SELECT] key in the Ready status. (2) (3) Using [ ] key or [ ] key.DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3. 3 .October 1999 . Figure 3-3-1: Stored Data Screen Quitting the Program (1) Press [SELECT] key on the Stored Data screen. The Analysis screen returns. PROCESSING STORED DATA This instrument is capable of storing data of up to 300 samples.Disp. The Select Menu screen appears. *Stored Data* Date 31/12 31/12 31/12 31/12 31/12 31/12 31/12 31/12 Time 09:59 10:05 10:10 10:25 10:28 10:30 10:40 10:50 No 123456789-12341*B QC01 M 123456789-12335 M 123456789-12337 M 123456789-12344 M 123456789-12345 A 123456789-12346 A 123456789-12341*M WB QC WB WB PD PD WB WB DGH DGH DGH DGH DGH E DG GH D No. 90 4. up to four parameters are displayed on one page. Stored Data Screen [5/7] Figure 3-3-2: Page Selection in the Stored Data Screen *Stored Data* Date 31/12 31/12 31/12 31/12 31/12 31/12 31/12 31/12 Time 09:59 10:05 10:10 10:25 10:28 10:30 10:40 10:50 No 123456789-12341*B QC01 M 123456789-12335 M 123456789-12337 M 123456789-12344 M 123456789-12345 A 123456789-12346 A 123456789-12341*M WB QC WB WB PD PD WB WB DGH DGH DGH DGH DGH E DG GH D No.532. When a new sample is analyzed.3 15.October 1999 3-15 .5 29.1 18. the data of the last eight samples on the list are displayed.5 15.05 3.0 HCT 32.0 7. -12341* WB QC -12346 WB -12345 WB -12344 PD -12337 PD -12335 WB -12341* WB WBC 7.51 3. Figure 3-3-4: Stored Data Screen [2/7] Sysmex KX-21N Operator’s Manual -. Stored Data Screen [7/7] P6.5 7. Figure 3-3-3: Stored Data Screen [1/7] *Stored Data* No. When the first Stored Data screen is displayed after turning on the power.91 3.30+ 3.DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3 . 2 Stored Data Screen The Stored Data screen lists data of up to eight samples in the order of analysis.123456789-12341 [ENTER] to mark.8 34.57. Stored Data Screen [3/7] P4.98 HGB 14.97 4. Stored Data Screen [4/7] P7. will appear on the first page ([1/7]).1 7.4 35.7+ 7.Disp.2+ 31.2 5.123456789-12345 [ENTER] to mark.1 No. Stored Data Screen [6/7] P5. The analyzed date and information on the analysis data such as error mark etc.2 14. Stored Data Screen [1/7] P2.7 30.85 4.7 14. As to analysis data. 31/12 10:59 [1/7] 3:Chg.6+ RBC 3.1 13.8 12. Stored Data Screen [2/7] P3.5+ 7.0 40. its data is automatically added to the last line of the list. 31/12 10:50 [2/7] 3:Chg. and can be switched to the screen over seven pages with [ ] key or [ ] key.Disp. P1. 2 19. and press [3] key to return to Stored Data screen.1: Display of Analysis Result.123456789-12341 WBC RBC HGB HCT MCV MCH MCHC PLT + 7. the list scrolls down.2 1. For details on how to display Analysis screen. Figure 3-3-5: Stored Data Screen The screen can be switched with [ ] key or [ ] key as well as Analysis screen.October 1999 .0 44.6 .7 3.6 37.8 180 WB 31/12 10:50 31.Disp. refer to Chapter 3.7 32.9 9. [ENTER] key: Attaches or deletes marks.6 20.2 .3 .25.DISPLAY AND PROCESSING OF ANALYSIS RESULTS Key Operation for Stored Data Screen [ ] key: Moves up the underline cursor by one sample.5 2. When the underline cursor is at the bottom. 2:Output 3:Chg.6 49. 3-16 Sysmex KX-21N Operator’s Manual -. [ ] key: Moves down the underline cursor by one sample.5 LYM% MXD% NEUT% RDW-SD RDW-CV PDW MPV P-LCR 1:M.97 14. Section 2.] key: Allows you to correct the sample number at the underline cursor. [ ] key: Changes over the page. [3] key: Displays the data at the underline cursor by the same form as Analysis screen.7. [SAMPLE No. [ ].Discri.4 3.8 . *Stored Data* No.82. the list scrolls up. When the underline cursor is at the top.9. *Stored Data* No. • When you return to the Analysis screen.2 5.8 12.5 15.51 3.123456789-12345 1:Delete 31/12 10:30 [2/7] 3:Chg." "2: Output.90 4.2+ 31.7+ 7.30+ 3. the marking is made continuously. -12341* WB QC -12335 WB -12337 WB -12344 PD -12345 PD -12346 WB -12341* WB WBC 7.3 15.6+ RBC 3. Sample No.DISPLAY AND PROCESSING OF ANALYSIS RESULTS Marking To mark the analysis data.532. Input Attributes Mode Indication Not-output Mark Date 31/12 31/12 31/12 31/12 31/12 31/12 31/12 31/12 Data at Underline Cursor Time 09:59 10:05 10:10 10:25 10:28 10:30 10:40 10:50 No 123456789-12341*B QC01 M 123456789-12335 M 123456789-12337 M 123456789-12344 M 123456789-12345 A 123456789-12346 A 123456789-12341*M WB QC WB WB PD PD WB WB DGH DGH DGH DGH DGH E DG GH D Error Mark No.5 7. 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." When the mark is already attached.2 14.91 3.98 HGB 14.57.5+ 7.4 35. NOTE: • When you keep pressing [ENTER] key.Disp.7 30.8 34. 31/12 10:10 [1/7] 3:Chg. press [ENTER] key to delete it.97 4. 2:Output Figure 3-3-6: Marking the Data Display Contents of Stored Data Screen Time Analyzed Date Analyzed *Stored Data* Sample No.0 40.1 18.October 1999 3-17 .0 7.1 7. all the marks on analysis data are deleted. specify an analysis data using the underline cursor and press [ENTER] key.Disp.0 HCT 32.123456789-12335 [ENTER] to mark.05 3.5 29. the Menu Display Area displays: "1: Deletion.1 No. Figure 3-3-7: Stored Data Screen [1/7] Sysmex KX-21N Operator’s Manual -.85 4.7 14.1 13. Sample No. QC data are displayed in the format of "QC + File No.1 No. D : The data has not been printed to the data printer.98 HGB 14.51 3.1 13.57. 1. The mark disappears when output.7+ 7.8 12.0 7. *Stored Data* Analysis Data No. The mark disappears when 2.532.8 34.5+ 7.7 14. 31/12 10:10 [2/7] 3:Chg. The sample number is displayed by all of the 15 digits on [1/7] screen. A: The sample number was input by automatic increment. PD: Pre-diluted mode 3. 3.1 18. 1. but displayed by only 6 last digits on [2/7] to [7/7] screens.123456789-12335 [ENTER] to mark. 2. Mode Indication The analysis mode for stored data is displayed.2 14. Sysmex KX-21N Operator’s Manual -.2 5.Disp. processed on an identical analysis date are marked with * at the ends of the Nos.DISPLAY AND PROCESSING OF ANALYSIS RESULTS Mode Indication Sample No. printed.30+ 3.05 3.7 30." Sample No. The sample No.85 4.0 40.2+ 31. B: The sample number was input with the handy barcode reader.0 HCT 32. QC: QC data Not-output Mark It is displayed whether to output data to an external printer or the host computer by the marks. WB: Whole blood mode 2.6+ RBC 3. The mark disappears when printed.4 35. Input Attributes How to input the sample number is displayed by the marks 1. M: The sample number was input with the panel keyboard. of stored data is displayed.October 1999 3) 4) 5) 3-18 .97 4. 3. Identical sample Nos.1 7. Figure 3-3-8: Stored Data Screen [2/7] 1) 2) Data/Time Analyzed The date and the time when analyzed the analysis data are displayed.5 29. -12341* WB QC -12335 WB -12337 WB -12344 PD -12345 PD -12346 WB -12341* WB Data at Underline Cursor WBC 7.5 15. G : The data has not been printed to the graphic printer.91 3.3 15. "PD" is indicated for the pre-diluted mode while no indication is given for the whole blood mode.5 7. H : The data is not output to the host computer.90 4. + : The data exceeds the upper Mark Limits. RDW-CV Stored Data Screen [7/7]: PDW.. . MXD%. -.-. NOTE: • When analysis is made in the pre-diluted mode. . Section 4: Patient Limit. 2.: The data exceeds the lower Mark Limits." 8) Data at Underline Cursor The sample number (15 digits). For details. has caused errors in analysis data. MPV. * : The data is low in reliability. * * * . RBC. * : When data could not be calculated due to instrument failure. MCHC. HCT Stored Data Screen [3/7]: MCV. 3. +: When data has exceeded the display range. 3. P-LCR • Manual Discrimination Data As to data changed through manual discrimination. HGB. LYM%. the marks below are attached to the affected data: 1. MXD#. analysis values are reversedisplayed. 2. -: When data could not be calculated due to data error.October 1999 3-19 . and 3.DISPLAY AND PROCESSING OF ANALYSIS RESULTS 6) 7) Error Mark The E mark is displayed in data which an error occurs.. + + +. the analyzed date. Analysis Data Analysis data of 19 parameters are displayed on over six pages of [2/7] to [7/7]. NEUT# Stored Data Screen [6/7]: RDW-SD. 2. particle distribution analysis parameters are displayed in ". • Indication when Error When an analysis error. PLT Stored Data Screen [4/7]: WBC. Sysmex KX-21N Operator’s Manual -. Stored Data Screen [2/7]: WBC. • The Mark Limits with "+" and "-" can be set by the customer. NEUT% Stored Data Screen [5/7]: WBC. and the analyzed time of the analysis data on the underline cursor are displayed. NOTE: • The marks are added with the priority order of 1.-. LYM#. ! : The data is out of the linearity limit. etc. MCH. refer to Chapter 10. • Abnormal Marks The marks on the left of analysis data indicate the following: 1. When you press [SELECT] key.DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3 . (2) Press [1] key to select "1: Deletion. 3 Deletion This menu allows deletion of marked analysis data from stored data. specify the analysis data you want to delete and press [ENTER] key. make sure the KX-21N completes any output operation to the printer or host computer. (4) NOTE: • Before deleting data. the process is canceled." The Deletion Confirmation message appears. Execution of Deletion (1) Using the underline cursor. Press [ENTER] key to execute the selected process. [NO]: Cancels deletion. Delete? YES NO Figure 3-3-9: Deletion Confirmation Message (3) Using [ ] key or [ ] key. move the cursor to select "Yes" or "NO. 3-20 Sysmex KX-21N Operator’s Manual -.October 1999 ." [Yes]: Deletes the marked analysis data. This puts the mark on the analysis data. 3 External Output. 1:Host 2:DP 3:GP 4:LP 5:IP 6:IP Feed 7:Cancel Figure 3-3-10: Pop-up Menu (3) Using [ ] key or [ ] key to move the cursor to the desired printer." The pop-up menu to select the output destination will appear. (2) Press [2] key to select "2: Output. [1: Host]: Output the data to the host computer. This puts the mark on the analysis data. (The external printer is an option. refer to Chapter 2.) Printing to Printer (1) Using the underline cursor. When the print to the printer is completed. Refer to "Output to Host Computer" described later. Section 2.DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3 . Section 5. NOTE: • For print format other than the LP (list print with the graphic printer). 4 External Output This menu allows the marked analysis data to be printed by the built-in/external printer. [6:IP Feed]: Carries out the paper feed of the built-in printer. [2: DP]: This cannot be selected. disappearing the not-output mark for the printer which corresponding to the printed analysis data. specify the analysis data you want to print and press [ENTER] key. this can be selected. or output to the host computer.October 1999 3-21 . [3: GP]: The graphic printer starts graphic printing the marked analysis data. Sysmex KX-21N Operator’s Manual -. [7: Cancel]: When two or more analysis data are printed. and press [ENTER] key. [4: LP]: The graphic printer starts list printing the marked analysis data. and the print will be interrupted when you select this.2: Printing of Analysis Result or Chapter 3. [5: IP]: The built-in printer starts printing the marked analysis data. 9 9.0 2.52 15.October 1999 . 1:Host 2:DP 3:GP 4:LP 5:IP 6:IP Feed 7:Cancel Figure 3-3-12: Pop-up Menu (3) Using [ ] key or [ ] key to move the cursor to [1: Host].4 59. specify the analysis data you want to output to the host computer and press [ENTER] key.8 MCHC MPV PLT P-LCR page( 1) RDW-SD RDW-CV Figure 3-3-11: Stored Data List Print Output to Host Computer (1) Using the underline cursor. Date Ana. 123456789-12344 31/10/1999 12:15 W R P P E Mode Err." The pop-up menu to select the output destination will appear.DISPLAY AND PROCESSING OF ANALYSIS RESULTS Contents of Printing List print with the graphic printer Print Date 31/10/1999 Print Time 16:40 Sample No.0 HGB NEUT% 14.4 2.7 8.Inf. and press [ENTER] key.2 RBC MXD% 4. The not-output of the output analysis data to the host computer disappears when the output to the host computer is completed.2 MCV MXD# 80. 3-22 Sysmex KX-21N Operator’s Manual -. (2) Press [2] key to select "2: Output.3 4.3 40. The analysis data is output to the host computer in order that the mark is put. WBC LMY% 7. This puts the mark on the analysis data.3 8.1 206 14.8 HCT LMY# 36.1 MCH PDW NEUT# 32.3 27.0 13. 0 7. -12345 PD -12346 WB -12341* WB 5.6+ 3. The sample number is changed.98 15.1 No.0 40. When the confirmation message appears.] key to correct a sample number of analysis data.5 15. Sysmex KX-21N Operator’s Manual -.123456789-12345 [ENTER] to mark. Figure 3-3-13: Correcting a Sample Number (2) (3) Use the numeric keypad to enter a new sample number. and the sample number input attribute becomes "M". 5 Correcting a Sample Number Use the [SAMPLE No. The sample number on the bottom of the screen will be highlighted.] key.4 35. 31/12 10:30 [2/7] 3:Chg. then press the [SAMPLE No. then press the [ENTER] key. select the [Set] button.05 3.October 1999 3-23 .2+ 31. (1) Use the underline cursor to select the desired analysis data.1 18.90 4.57.Disp.DISPLAY AND PROCESSING OF ANALYSIS RESULTS 3 . ..........................................1 Replenish Reagent .. 4-2 DAILY MAINTENANCE AND PROCEDURE ....... 4-41 9......1 Clean Sample Rotor Valve (SRV)......................2 Reset SRV Cycle Counter .......................... 4-41 4........2 Clean Rinse Cup .......................4-36 8.... 4-9 5...............4-26 7... 9............................... 3 INTRODUCTION ...................4 Supplies List.......4-40 CONFIRMATION OF CYCLE NUMBER............................... 5.................................. 8.. 4-7 4........................... 4-16 6............... 6..........................4 Replace Waste Tank .........2 Clean Transducer (Rinse Sequence) ................................................................................................................4-28 7..................................................................................2 Check Trap Chamber Level and Discard .... Sysmex KX-21N Operator’s Manual -...... 4-1 KX-21N MAINTENANCE CHECKLIST ..............................October 1999 .........4-24 7............4-32 SUPPLIES REPLACEMENT............ 4-33 8.................................... 4-4 3........1 Clean TD Chamber and Diluted Sample Line (Shutdown)................. 4-24 7.......1 Clean SRV Tray.........................1 Clean Waste Chamber (Rinse Sequence)........... 4-7 MONTHLY MAINTENANCE AND PROCEDURE .. 4-9 5......................... 7..4-16 6..........4-33 8....................1 Operation Procedure ..............4-37 8......CHAPTER 4 MAINTENANCE AND SUPPLIES REPLACEMENT 1..................................4-22 AS-NEEDED MAINTENANCE AND PROCEDURE..........4-12 EVERY 3-MONTH MAINTENANCE AND PROCEDURE ..........3 Replace Printer Paper................. 4-4 3................................2 Replace Fuse................................................................. 2.........3 Clean WBC/RBC Transducer Aperture ...............1 Auto Rinse .............................................. 4-6 WEEKLY MAINTENANCE AND PROCEDURE......................................................... Replace fuses.October 1999 4-1 . it is necessary to give scheduled maintenance. As-Needed Maintenance Auto Rinse Clean the rinse cup. INTRODUCTION To ensure that the instrument can function in its best state. Perform maintenance according to the schedule below and record the result in the Maintenance Checklist. Clean WBC/RBC transducer aperture. Replace printer paper. and discard if necessary. Sysmex KX-21N Operator’s Manual -. Monthly Maintenance (or Every 2500 Samples) Clean the waste chamber (rinse sequence). Every 3-Month Maintenance (or Every 7500 Samples) Clean the sample rotor valve (SRV). This chapter describes supplies replacement together with these maintenance items.MAINTENANCE AND SUPPLIES REPLACEMENT 1.) Check trap chamber level. Replace the waste tank. Clean the transducer (rinse sequence). • Supplies Replacement Replenish reagent. • • • • • Daily Maintenance Clean the TD chamber and diluted sample line. Weekly Maintenance Clean the sample rotor valve (SRV) tray. (Execute shutdown. Signature KX-21N MAINTENANCE CHECKLIST Monthly Maintenance Maintenance item Clean waste chamber (Rinse sequence) Supplies Replacement Maintenance item Replenish reagent Replace fuse Replace printer paper Date. Signature Date.October 1999 Clean sample rotor valve (SRV) . 4-2 Year: Month: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 2122 23 24 25 26 27 28 29 30 31 Daily Maintenance Maintenance Item Day Execute shutdown Check trap chamber level and drain Signature Weekly Maintenance 1 Auto rinse Clean rinse cup As-Needed Maintenance 2 3 4 5 Maintenance item Date. Signature MAINTENANCE AND SUPPLIES REPLACEMENT Week Maintenance Item Clean sampling valve (SRV) tray Signature Clean WBC/RBC transducer aperture Replace waste tank Date. Signature Maintenance item Sysmex KX-21N Operator’s Manual -. Signature Date. Signature Clean transducer (Rinse sequence) Every 3-Month Maintenance Date.2. Date Expiry Signature STROM ATOLYSER.MAINTENANCE AND SUPPLIES REPLACEMENT Reagent Replenishment Record CELLPACK Lot No. Date Expiry Signature Lot No. Date Expiry Signature Sysmex KX-21N Operator’s Manual -.W H Lot No. Date Expiry Signature Lot No.October 1999 4-3 . MAINTENANCE AND SUPPLIES REPLACEMENT 3. 5 minutes. 1 Clean TD Chamber and Diluted Sample Line (Shutdown) By executing shutdown. set CELLCLEAN to the sample probe and press the start switch in that status.October 1999 . *Shutdown* Ready Aspirate CELLCLEAN. the transducer chamber and diluted sample line are cleaned. 3:Cancel Figure 4-3-1: Shutdown Screen NOTE: • When [3] key is pressed. and also at least once every 24 hours when this instrument is used continuously. While "Aspirating" is being displayed on the screen. (1) Press [SHUTDOWN] key in the Ready status. shutdown is canceled and the Analysis screen returns. (2) In executing shutdown. It will take approx. The Shutdown screen appears. Start Switch Figure 4-3-2: Pressing the Start Switch 4-4 Sysmex KX-21N Operator’s Manual -. DAILY MAINTENANCE AND PROCEDURE 3 . Perform shutdown after completion of the day's work. keep holding CELLCLEAN in the same state. 1:Re-boot Figure 4-3-4: Shutdown Completion Message Screen Sysmex KX-21N Operator’s Manual -. *Shutdown* Rinsing Please wait. Figure 4-3-3: Shutdown Execution Screen CAUTION: • To remove CELLCLEAN. Otherwise. it can damage the skin or clothes. shutdown is executed automatically. After that. take care not to have it adhere to the skin or clothes. remove CELLCLEAN from the sample probe. it cannot be canceled until completed. beep. lower it straight down. flush it away using plenty of water.informing the completion of aspiration.beep. (4) When shutdown is completed and the following message is displayed. turn off the power switch on the right side of the unit. NOTE: • Once shutdown is executed. Turn OFF the power.MAINTENANCE AND SUPPLIES REPLACEMENT WARNING • Because CELLCLEAN is a strong alkaline detergent. . (3) When the buzzer sounds two times .October 1999 4-5 . Take care not to bend the sample probe. If the skin or clothes should come in touch with it. *Shutdown* Shut-down sequence was completed. T ra p C hamber Fl oat Loosen Figure 4-3-5: Checking the Trap Chamber (3) After discarding the liquid. mount the chamber. If your hands are contaminated by the liquid. After completion of operation.October 1999 . Turn the chamber on the left side of the unit counterclockwise and remove.MAINTENANCE AND SUPPLIES REPLACEMENT NOTE: • Shutdown will take approximately 5 minutes. Make sure the float is inside. infection of bacteria or the like can occur. (1) (2) Turn off the power and wait approximately 30 seconds. • When the [1] key is pressed. Contact Sysmex service representative. 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. Place it with its pointed end facing upward. • Pay attention to the direction of the float in the chamber. wash hands with disinfectant. 3 . 4-6 Sysmex KX-21N Operator’s Manual -. the hydraulic system may have failed. CAUTION • If liquid collects everyday. WARNING • When discarding the trap chamber liquid. the unit will restart. always wear rubber gloves. Probe Fixing Screw Tray Figure 4-4-1: Removing the SRV Tray • When removing the tray. always wear rubber gloves. Open the front cover of the main unit. 1 Clean SRV Tray Clean the sample rotor valve (SRV) tray once a week in the following procedure: WARNING • When cleaning the SRV tray.MAINTENANCE AND SUPPLIES REPLACEMENT 4. etc. air can enter the system and affect the data. take care not to loosen the probe fixing screw. After completion of operation. Remove the SRV tray. Tray Figure 4-4-2: Washing the SRV Tray Sysmex KX-21N Operator’s Manual -. If analysis is made with the screw loosened. If your hands are contaminated by blood.October 1999 4-7 . WEEKLY MAINTENANCE AND PROCEDURE 4 . CAUTION (4) Wash the SRV tray using tap water. wash hands with disinfectant. (1) (2) (3) Turn off the power of the main unit and wait approximately 30 seconds.. infection of bacteria or the like can occur. (7) Close the front cover of the main unit.October 1999 . If analysis is made with the screw loosened. then wipe off water. CAUTION CAUTION: • Mount the SRV tray properly as to the face/bottom and the direction.MAINTENANCE AND SUPPLIES REPLACEMENT (5) (6) Make sure no contaminants remain. Re-mount the SRV tray to the original state. make sure the probe fixing screw is not loose. air can enter the system and affect the data. 4-8 Sysmex KX-21N Operator’s Manual -. • After mounting the tray. 2515 Date last serviced 1/12/1999 1:Exec.October 1999 4-9 ." the start-up process continues without cleaning the waste chamber. Cycle No. you can execute the waste chamber cleaning by choosing "7: Maintenance" on the Select Menu screen. the above message is displayed at start-up. MONTHLY MAINTENANCE AND PROCEDURE 5 .Clean 3:Cancel Figure 4-5-1: Scheduled Maintenance Message Screen When this message appears.MAINTENANCE AND SUPPLIES REPLACEMENT 5. the message is displayed once a month or for every 2500 samples to instruct the scheduled maintenance. • Even when the above message is not displayed. then "1: Clean W. Until the waste chamber is cleaned. Sysmex KX-21N Operator’s Manual -. *Scheduled Maint. It will take approx. Chamber" on the Maintenance Menu screen. 15 minutes. after cleaning. Clean.* Clean the Waste Chamber." and clean the waste chamber by the following procedure: NOTE: • When you press [3] key and select "3: Cancel. 1 Clean Waste Chamber (Rinse Sequence) When the power is turned on. press [1] key to select "1: Exec. Otherwise. (2) Set CELLCLEAN to the sample probe and press the start switch in that status. 4-10 Sysmex KX-21N Operator’s Manual -. The Clean W.Chamber* Ready Aspirate CELLCLEAN It will take approx. it can damage the skin or clothes. 2515 Date last serviced 1/12/1999 3:Cancel Figure 4-5-2: Clean W. keep holding CELLCLEAN in the same status.October 1999 .MAINTENANCE AND SUPPLIES REPLACEMENT (1) Press [1] key to select "1: Exec. take care not to have it adhere to the skin or clothes. flush it away using plenty of water. Start Switch Figure 4-5-3: Pressing the Start Switch WARNING • Since CELLCLEAN is a strong alkaline detergent. Until the waste chamber is cleaned. Chamber Screen NOTE: • When you press [3] key and select "3: Cancel. Chamber screen will display the message instructing the following operation: *Clean W. the above message is displayed at start-up. While "Aspirating" is being displayed on the screen." the start-up process continues without cleaning the waste chamber. Clean" on the Scheduled Maintenance Message screen. If the skin or clothes should come in touch with it. after cleaning. Cycle No. 15 minutes. Figure 4-5-4: Screen during Waste Chamber Cleaning CAUTION: • To remove CELLCLEAN. After that. *Clean W. beep .beep. NOTE: • When this operation is completed. then the system turns to the Ready status. (4) (5) When the waste chamber cleaning is completed. the auto rinse and background check are executed. Check to see that no background error occurs. For the confirmation of waste chamber cycle number. the waste chamber cleaning is executed automatically. Sysmex KX-21N Operator’s Manual -. execute the auto rinse.October 1999 4-11 . the waste chamber cycle counter is automatically reset.Chamber* Please wait. Should background error occur. lower it straight down. . Take care not to bend the sample probe.informing completion of aspiration. Section 9: CONFIRMATION OF CYCLE NUMBER. remove CELLCLEAN from the sample probe.MAINTENANCE AND SUPPLIES REPLACEMENT (3) When the buzzer sounds two times . refer to Chapter 4. *Scheduled Maint. 4-12 Sysmex KX-21N Operator’s Manual -. 7 minutes. the above message is displayed at start-up. Even when the clogging is not removed. • If this rinse sequence fails to remove clogging. NOTE: • When you press [3] key and select "3: Cancel. clean the transducer using the same procedure. the message is displayed once a month or for every 2500 samples to instruct the scheduled maintenance. then "2: Clean Transducer" on the Maintenance Menu screen. 2 Clean Transducer (Rinse Sequence) When the power is turned on.MAINTENANCE AND SUPPLIES REPLACEMENT 5 .October 1999 . • Even when the above message is not displayed. Cycle No.3: Clean WBC/RBC Transducer Aperture. Regarding cleaning with the brush. Clean 3:Cancel Figure 4-5-5: Scheduled Maintenance Message Screen When this message appears. clean with the brush. Clean. after cleaning. refer to Chapter 4. Section 7.* Clean the Transducer." and clean the transducer by the following procedure: In addition. 2515 Date last serviced 1/12/1999 1:Exec. It will take approx. the error message of clogging is displayed." the start-up process continues without cleaning the transducer. press [1] key to select "1: Exec. you can execute the transducer cleaning by choosing "7: Maintenance" on the Select Menu screen. Until the transducer is cleaned. Cycle No. Clean" on Scheduled Maintenance Message screen. Open the transducer cover.October 1999 4-13 . 2515 Date last serviced 1/12/1999 3:Cancel 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. *Clean Transducer* Ready Pour CELLCLEAN in transducer chamber and press START switch. the above message is displayed at start-up.MAINTENANCE AND SUPPLIES REPLACEMENT (1) Press [1] key to select "1: Exec. (2) (3) Open the front cover of the main unit. Figure 4-5-7: Opening the Transducer Cover Sysmex KX-21N Operator’s Manual -. Fluid in the transducer is drained and the Clean Transducer screen appears. after cleaning. Until the transducer is cleaned. October 1999 . take care not to have it adhere to the skin or clothes.MAINTENANCE AND SUPPLIES REPLACEMENT (4) Using the filler provided with the unit. it can damage the skin or clothes. possibly causing electric shocks or leakage. Close the front cover of the main unit. pour approximately 1 mL each of CELLCLEAN into the WBC transducer and RBC transducer. CAUTION • Do not pour more than 1 mL of detergent (CELLCLEAN) into the chamber. (5) (6) Close the transducer cover. 4-14 Sysmex KX-21N Operator’s Manual -. flush it away using plenty of water. If the skin or clothes should come in touch with it. CAUTION: • Take care not to have detergent (CELLCLEAN) adhere to the chamber side wall. Filler Figure 4-5-8: Pouring CELLCLEAN WARNING • Since CELLCLEAN is a strong alkaline detergent. Otherwise. It may overflow. NOTE: • When this operation is completed. Check to see that no background error occurs. then the system turns to the Ready status. Sysmex KX-21N Operator’s Manual -. Figure 4-5-9: Screen during Transducer Cleaning (8) (9) When the transducer cleaning is completed. For the confirmation of transducer cycle number. the transducer cycle counter is automatically reset. Should background error occur. refer to Chapter 4. *Clean Transducer* Please wait.October 1999 4-15 . The transducer cleaning is executed. Section 9: CONFIRMATION OF CYCLE NUMBER. execute the auto rinse.MAINTENANCE AND SUPPLIES REPLACEMENT (7) Press the start switch. the auto rinse and background check are executed. October 1999 . screen and executed cleaning when the power was off. Cycle No. after cleaning. take care not to have it adhere to the skin or clothes. the above message is displayed at start-up. etc. SRV cycle counter will not be reset. If your hands are contaminated by blood. always wear rubber gloves. or when you selected "3: Cancel" on the Scheduled Maint. • When you want to clean before this message appears. If the skin or clothes should come in touch with it.2: Reset SRV Cycle Counter. Otherwise. reset the cycle counter.. press [1] key to select "1: Exec. Until the sample rotor valve (SRV) is cleaned. making reference to Chapter 4. 1 Clean Sample Rotor Valve (SRV) When the power is turned on. 4-16 Sysmex KX-21N Operator’s Manual -. Then clean the sample rotor valve (SRV) by the following procedure: WARNING • When cleaning the sample rotor valve (SRV). NOTE: • When you press [3] key and select "3: Cancel. After completion of operation. Clean.Clean 3:Cancel Figure 4-6-1: Scheduled Maintenance Message Screen When this message appears.MAINTENANCE AND SUPPLIES REPLACEMENT 6. EVERY 3-MONTH MAINTENANCE AND PROCEDURE 6 . infection of bacteria or the like can occur. flush it away using plenty of water. [3] Continue to start up.* Clean the SRV. Section 6. it can damage the skin or clothes. *Scheduled Maint." the start-up process continues without cleaning the sample rotor valve (SRV). [1] Reset the cycle counter for SRV. • Because CELLCLEAN is a strong alkaline detergent. 7515 Date last serviced 1/12/1999 1:Exec." and reset the cycle counter. wash hands with disinfectant. the message is displayed once every three months or for every 7500 samples to instruct the scheduled maintenance. and you can turn OFF the power. Turn OFF the power.October 1999 4-17 . Open the front cover of the main unit." making the unit ready to be turned off.* SRV cycle counter was reset. always select "1: Exec. Figure 4-6-2: Clean SRV Screen CAUTION: • Before turning the power off. The SRV cycle counter is reset and the unit is ready to be turned off. Clean" on the Scheduled Maintenance Message screen.MAINTENANCE AND SUPPLIES REPLACEMENT (1) Press [1] key to select "1: Exec. Probe Fixing Screw Tray Figure 4-6-3: Removing the Tray Sysmex KX-21N Operator’s Manual -. Clean. Remove the sample rotor valve (SRV) tray. (2) (3) (4) Turn off the power of the main unit and wait approximately 30 seconds. *Scheduled Maint. MAINTENANCE AND SUPPLIES REPLACEMENT CAUTION • When removing the tray. take care not to loosen the probe fixing screw. SRV Fixing Screw Loosen Figure 4-6-5: Removing the SRV Fixing Screw 4-18 Sysmex KX-21N Operator’s Manual -. (6) Remove the SRV fixing screw. If analysis is made with the screw loosened. (5) Gently push down the rinse cup using both hands. there is a possibility that the sample probe may bend when the sample rotor valve (SRV) is removed. air can enter the system and affect the data. 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.October 1999 . take care not to bend the sample probe. If left as it is. it can cause current leakage or electric shocks. If it does. Rotary Valve Figure 4-6-7: Removing the Rotary Valve • When removing the valve. reagent could leak from the tube. Sample Rotor Valve Figure 4-6-6: Removing the Entire SRV CAUTION: • Take care not to pull out the valve excessively. • When removing the valve. This is to prevent applying excess force to the tube connected to the valve.MAINTENANCE AND SUPPLIES REPLACEMENT (7) Remove the entire sample rotor valve (SRV). They can be easily removed when you gently twist and slide each one. CAUTION NOTE: • The valve components are in close contact with one another. (8) Remove the rotary valve.October 1999 4-19 . wipe it clean using cloth. Sysmex KX-21N Operator’s Manual -. CAUTION CAUTION: • Do not use any detergent other than CELLCLEAN. By using CELLCLEAN together with distilled water. since flaws or scratches can cause blood leakage and incorrect analysis results. Although the sample rotor valve (SRV) is corrosion-resistant against CELLCLEAN. can be removed easily. 4-20 Sysmex KX-21N Operator’s Manual -. always clean it with distilled water. CAUTION (12) Install one each valve at a time. (11) Make sure the valve contact surfaces are completely free from dirt or dust. wipe it off completely to prevent troubles to the unit or other components. etc. blood leakage can occur and correct analysis results may not be obtained. and assemble the sample rotor valve (SRV) in the reverse order to disassembly.October 1999 . After cleaned with CELLCLEAN. Figure 4-6-8: Cleaning the Contact Faces • Take care not to inflict flaws or scratches on valve surfaces. dirt. (10) Clean the contact surfaces of the fixed and rotary valves using a gauze moistened with distilled water. • If the device is used with dirt or dust attaching on valve contact surfaces. stuck objects.MAINTENANCE AND SUPPLIES REPLACEMENT (9) Clean the rotary valve using distilled water or 1:10 dilution of CELLCLEAN detergent. October 1999 4-21 . NOTE: • When this operation is completed. CAUTION: • Mount the SRV tray properly as to its face/bottom and the direction. (15) Turn on the main unit and make sure that the background error has not occurred. • Make sure the rinse cup is pushed all the way up with the sample probe inserted in the hole. (14) Close the front cover of the main unit. refer to Chapter 4. (16) Perform quality control and make sure that there is no functional problem. If it is not.MAINTENANCE AND SUPPLIES REPLACEMENT CAUTION: • Mount the rotary valve with the notch facing upward and the metal knob coming between the stoppers. (13) Mount the SRV tray to the original position and gently push up the rinse cup to the top using both hands. Metal Knob Guide Pin for Rotary Valve Stopper Groove (View of Left Side) Figure 4-6-9: Rotary Valve • Confirm that the metal knob is between the stoppers. "Rinse Motor Error" will occur. Sysmex KX-21N Operator’s Manual -. the SRV cycle counter is automatically reset. making it impossible to continue the operation. For confirmation of SRV cycle number. If the power is turned on with the rinse cup staying lowered. Section 9: CONFIRMATION OF CYCLE NUMBER. malfunction will occur. Use [ ] key or [ ] key.MAINTENANCE AND SUPPLIES REPLACEMENT 6 . move the cursor to select "3: Reset SRV Counter.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. *Maintenance* 1:Clean W. • For SRV cleaning procedure.October 1999 .1: Clean Sample Rotor Valve (SRV)." 4-22 Sysmex KX-21N Operator’s Manual -. 2 Reset SRV Cycle Counter If you have cleaned the SRV other than the time when instructed on the Scheduled Maintenance screen. The Maintenance Menu screen appears. the message will instruct you to perform scheduled maintenance within three months (or before analyzing 7500 samples). refer to Chapter 4. always reset the SRV cycle counter manually. NOTE: • If you continue using the unit without resetting the SRV cycle counter. Section 6. The Select Menu screen appears." Press [ENTER] key. (1) (2) (3) Press [SELECT] key in the Ready status. move the cursor to select "7: Maintenance. October 1999 4-23 . after cleaning" is reset to "0. then the Analysis screen returns. after cleaning. Cycle No. *Reset SRV Counter* [1] SRV cycle counter will be reset. The Rest SRV Counter screen appears. NOTE: • Press [3] key to select "3: Cancel." "Cycle No. Sysmex KX-21N Operator’s Manual -. 6015 Date last serviced 1/12/1999 1:Reset 3:Cancel Figure 4-6-11: Reset SRV Counter Screen (6) Press [1] key to select "1: Reset." the date of the present day is entered in the "Date last serviced" column.MAINTENANCE AND SUPPLIES REPLACEMENT (5) Press [ENTER] key. • For confirmation of SRV cycle counter. and the Analysis screen returns." The cycle counter is not reset. Section 9: CONFIRMATION OF CYCLE NUMBER. refer to Chapter 4. Settings 00:PU Sleep Figure 4-7-1: Select Menu Screen (3) Press [ENTER] key. The Select Menu screen appears. Using [ ] key or [ ] key. Background check is also implemented to allow checking whether the unit is in normal status or not. The Auto Rinse cleans all the lines in the unit and drains all waste. AS-NEEDED MAINTENANCE AND PROCEDURE When the transducer is clogged or the waste tank becomes full.October 1999 . perform the necessary maintenance. Auto Rinse and background check are performed. *Auto Rinse* NOTE: Please wait.MAINTENANCE AND SUPPLIES REPLACEMENT 7. Figure 4-7-2: Auto Rinse Execution Screen 4-24 Sysmex KX-21N Operator’s Manual -. each menu can be selected directly by entering a numeral from the numeric keys. (1) (2) Press [SELECT] key in the Ready status. • On the Menu screen. 1 Auto Rinse Execute the Auto Rinse at background check or when the unit has been left idle without shutdown performed." *SELECT* 1:Stored Data 2:Quality Control 3:Calibration 4:Replace Lyse 5:Auto Rinse 6:Settings 7:Maintenance 8:Periph. 7 . move the cursor to select "5: Auto Rinse. This stops the alarm and the Action Message screen appears. In case background value still exceeds tolerance. background check is repeated a maximum of twice. When the background value of any parameter exceeds tolerance.1 [g/dL] or less 10 [×103/µL] or less Table 4-7-1: Background tolerance Sysmex KX-21N Operator’s Manual -. (Refer to Chapter 7: TROUBLESHOOTING ). Press [HELP] key. Follow the Action Message screen and take appropriate action.MAINTENANCE AND SUPPLIES REPLACEMENT NOTE: • After Auto Rinse.02 [×106/µL] or less 0. • Background tolerance WBC RBC HGB PLT 0.3 [×103/µL] or less 0.October 1999 4-25 . background check is executed. the message "Background Error" appears while the alarm starts sounding. (1) (2) (3) Turn off the power of the main unit and wait approximately 30 seconds. etc. always wear rubber gloves. and 3 as shown below.MAINTENANCE AND SUPPLIES REPLACEMENT 7 . 2 Clean Rinse Cup When the rinse cup has any blood on it or is clogged. Make sure the rinse cup is removed completely from the sample probe. After completion of operation. Sample Probe Rinse Cup Figure 4-7-3: Pushing Down the Rinse Cup (4) Remove the rinse cup in the order of 1.October 1999 . Rinse Cup 1 2 3 Figure 4-7-4: Removing the Rinse Cup 4-26 Sysmex KX-21N Operator’s Manual -. wash hands with disinfectant. 2.. If your hands are contaminated by blood. infection of bacteria or the like can occur. Open the front cover of the main unit. clean it by the following procedure: WARNING • When cleaning the rinse cup. Gently push down the rinse cup using both hands. MAINTENANCE AND SUPPLIES REPLACEMENT (5) Clean the rinse cup using tap water. Figure 4-7-5: Cleaning the Rinse Cup (6) (7) Make sure no contaminant remains on the rinse cup and wipe off water. 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. Sysmex KX-21N Operator’s Manual -- October 1999 4-27 MAINTENANCE AND SUPPLIES REPLACEMENT 7 . 3 Clean WBC/RBC Transducer Aperture If the transducer aperture clogging persists, clean the transducer aperture using the brush by the following procedure: WARNING • 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. (1) (2) (3) Preparation Press [SELECT] key in the Ready status. The Select Menu screen appears. Use [ ] key or [ ] key, move the cursor to select "7: Maintenance." 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) (5) Use [ ] key or [ ] key, move the cursor to select "4: Drain TD Chamber." 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. 4-28 Sysmex KX-21N Operator’s Manual -- October 1999 MAINTENANCE AND SUPPLIES REPLACEMENT (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.* Fluid in T.D.Chamber was drained. Turn power OFF and dab the aperture with transducer brush. See the Operator's Manual. 3:Cancel 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. (1) (2) (3) Clean Transducer Aperture Turn off the power and wait approximately 30 seconds. Open the front cover of the main unit. Loosen the screw and open the transducer cover. Loosen Screw Transducer Cover Figure 4-7-9: Opening the Transducer Cover WARNING • When the power is on, never open the transducer cover. This is to prevent possible electric shocks. Sysmex KX-21N Operator’s Manual -- October 1999 4-29 MAINTENANCE AND SUPPLIES REPLACEMENT (4) Confirm that reagent in the transducer chamber has been drained. WBC Transducer RBC 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. CAUTION (6) Apply CELLCLEAN on the brush provided, and dab by lightly prodding the brush against the transducer aperture. Aperture Brush Figure 4-7-12: Cleaning the Aperture 4-30 Sysmex KX-21N Operator’s Manual -- October 1999 MAINTENANCE AND SUPPLIES REPLACEMENT 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. CAUTION (8) (9) Close the transducer cover and main unit front cover. Then turn on the power. Check to see that background error has not occurred. Sysmex KX-21N Operator’s Manual -- October 1999 4-31 MAINTENANCE AND SUPPLIES REPLACEMENT 7 . 4 Replace Waste Tank When the waste tank has become full, replace it by the following procedure: WARNING • 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) (2) (3) (4) Turn off the power of the main unit and wait approximately 30 seconds. Make ready an empty waste container and remove the cap. Pull the tube off the waste container. Insert the tube in the new waste container and fix it using tape or the like. Tube Tape Waste 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. CAUTION 4-32 Sysmex KX-21N Operator’s Manual -- October 1999 Error Message (Analysis Screen) Replenish Diluent *Help* HELP Screen Reagent to Replenish CELLPACK Replenish Diluent Container. Sysmex KX-21N Operator’s Manual -. Although Analysis screen displays the Not Ready status. 1 Replenish Reagent When reagent becomes insufficient during analysis. while the screen displays the error message. of stored data can be performed.0 1:Asp.October 1999 4-33 .X. 3:Cancel Replenish Lyse *Help* STROMATOLYSER-WH Replenish Lyse Container.0. Reag.X 1:Asp. [1] Reaspirating Lyse ERR CODE:12490. the instrument comes to a stop. [1] Reaspirating Diluent ERR CODE:XXXXX. etc.Reag.MAINTENANCE AND SUPPLIES REPLACEMENT 8. the processing. SUPPLIES REPLACEMENT 8 . Press [HELP] key to change to the replenishment operation. 3:Cancel NOTE: • Press [3] key on the HELP screen and select "3: Cancel" to return to the Analysis screen. connect it securely in prior to starting analysis.30°C) for at least 24 hours before using. If it spills. to adhere to the tube. to prevent the floor color fading. sometimes develop a background error. • Take care not to spill reagent. CELLPACK 20 L 60 days 90 days CAUTION STROMATOLYSER-WH 500 mL Table 4-8-1: Expiration After Opening the Seal (2) Remove the cap from the new reagent bottle. and bacteria. • Replace only fresh and fully bottled lyse reagent. wash it away with reagent in use before mounting. etc. adheres to the tube. Starting analysis with disconnected float switch will give you an error message "No Lyse". correct analysis result may not be obtained. wipe it off immediately using wet cloth.October 1999 . If dust. take care to prevent entry of dirt. • After unpacking. Otherwise. CAUTION 4-34 Sysmex KX-21N Operator’s Manual -. correct analysis results may not be obtained. you do not need to disconnect the float switch. etc. • Leave the reagent at room temperature (15 .MAINTENANCE AND SUPPLIES REPLACEMENT (1) Make ready a new reagent and check to see that expiration date is not passed. Old or collected lyse reagent will affect the analysis results. dust. follow the precautions given on the Package Insert. • CELLPACK. if used just after delivery via transit. If disconnected. • When replacing lyse. 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. (4) Insert the cubitainer spout set straight down into the new reagent bottle and tighten the cap. etc. • In handling a reagent that may have frozen. Otherwise. (3) Remove the cap from the empty reagent bottle and pull out the cubitainer spout set straight up. The check is made here to see that background error has not occurred.MAINTENANCE AND SUPPLIES REPLACEMENT (5) When reagent replenishment is over. Enter the contents of replenishment in Reagent Replenishment Record. and then background check is performed. execute "4: Replace Lyse" on the Select Menu screen." Reagent is automatically aspirated. (6) NOTE: • If you replenish lyse before error message "No Reagent" appears.October 1999 4-35 . Reag. Sysmex KX-21N Operator’s Manual -. follow the instruction on the screen and press [1] key to select "1: Asp. replace it by the following procedure: (1) Disconnect the power cord on the right side of the main unit. WARNING • Before replacing the fuse. 117 VAC 266-5109-1 220/240 VAC 266-5292-6 Description Fuse 250 V 3. (2) Pressing the notch upward with a regular screwdriver. Fuse Type Time Lag Time Lag CAUTION 4-36 Sysmex KX-21N Operator’s Manual -. 19195 Table 4-8-2: Fuse Rating • For continued protection against risk of fire. Specification Part No. Fuse Fuse Cap Holder Notch Figure 4-8-2: Removing the Fuse Cap Holder (3) Replace the fuse and mount the fuse cap holder. When a fuse is blown. remove the fuse cap holder.MAINTENANCE AND SUPPLIES REPLACEMENT 8 . use the fuse of the specified type and rating.15 A ST4-3. 2 Replace Fuse The main unit employs overcurrent protective fuses.15A-N1 Fuse 250 V 2 A No. always turn off the power and disconnect the power cord to prevent possible electric shocks.October 1999 . Section 11: Peripheral Settings. then [Periph.) (1) (2) Open the front cover of the main unit. When you want to use built-in printer again. (Refer to Chapter 10. select "8: Periph. Release Lever Figure 4-8-4: Releasing the Lever Sysmex KX-21N Operator’s Manual -. press [HELP] key and replace printer paper of the built-in printer by the following procedure: *Help* IP paper empty [1] Restarting to print [3] Stop printing on IP To make IP on-line. Analysis is executed as usual but printing is not. Settings" to set. 3 Replace Printer Paper When the "IP paper empty" message appears on the screen.X 1:Print 2:Paper Feed 3:Stop Output Figure 4-8-3: "IP paper empty" Message Screen NOTE: • On the HELP screen. Settings] ERR CODE:XXXXX.X. press [3] and select "3: Stop Output" to stop printing on built-in printer.MAINTENANCE AND SUPPLIES REPLACEMENT 8 .October 1999 4-37 . press [SELECT]. Turn the release lever up to free the paper. MAINTENANCE AND SUPPLIES REPLACEMENT (3) Remove the bare paper core and mount a new printer paper. and turn the release lever down to secure. remove it together with the paper core. (4) Pass the printer paper as shown below. Figure 4-8-6: Securing the Release Lever 4-38 Sysmex KX-21N Operator’s Manual -. New Printer Paper Figure 4-8-5: Mounting a New Printer Paper NOTE: • When any printer paper remains.October 1999 . Figure 4-8-7: Cutting Off Paper (6) (7) Close the front cover of the main unit. Sysmex KX-21N Operator’s Manual -.October 1999 4-39 . Press [1] key and output any print data that is remaining on the memory.MAINTENANCE AND SUPPLIES REPLACEMENT (5) Cut off any printer paper extending from the upper part of the printer. 1 Chapter & Section for Reference Chapter 4.October 1999 . 4 Supplies List 1.) Chapter 4.) Chapter 4.1: Replace Reagent (Replacement of float switch is suggested if WBC/HGB background count will not drop when lyse has been replaced. 3. Reagents List Product Code 834-0161-8 884-0871-1 974-0521-6 Product Name CELLCLEAN (50 mL) CELLPACK (20 L) STROMATOLYSER-WH (500 mL × 3) General Name Detergent Diluent WBC/HGB Lyse Table 4-8-3: Reagents List 2. Consumable List Product Code 933-3601-9 943-1781-1 Product Name Brush No. Section 7. Section 8.3: Replace Printer Paper 973-3041-7 Float Switch No. Section 8. 2 A No. Section 8.3: Clean WBC/RBC Transducer Aperture. 23 266-5292-6 266-5109-1 921-0351-8 Fuse 250 V. Section 8.MAINTENANCE AND SUPPLIES REPLACEMENT 8 .) Chapter 4.15 A ST4-3.1: Replace Reagent (Replacement of spout kit is suggested if background count will not drop when diluent has been replaced. 1 Assembly Cubitainer Spout Kit No.15A-N1 Paper Thermal F1-2 Heat-Sensitive Paper (5 rolls per pack) Table 4-8-4: Consumable List 4-40 Sysmex KX-21N Operator’s Manual -. 19195 Fuse 250 V. Section 8.) Chapter 4.2: Replace Fuse (117 VAC Spec. Chapter 4.2: Replace Fuse (220/240 VAC Spec. 1 Operation Procedure (1) (2) (3) Press [SELECT] key in the Ready status. The Select Menu screen appears. this unit has the functions of cycle No. The Maintenance Menu screen appears. display and automatic reset. each menu can be selected directly by entering a numeral from the numeric keys." Press [ENTER] key. whichever comes first.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) (5) Using [ ] key or [ ] key. The Status Display screen 1 appears." Press [ENTER] key. and sample rotor valve (SRV). move the cursor to select "7: Maintenance. NOTE: • On the Menu screen.October 1999 4-41 . CONFIRMATION OF CYCLE NUMBER To let you know when to perform maintenance.MAINTENANCE AND SUPPLIES REPLACEMENT 9. Cleaning of waste chamber Cleaning of transducer Cleaning of sample rotor valve (SRV) Every 2500 cycles or every month Every 2500 cycles or every month Every 7500 cycles or every 3 months Table 4-9-1: Maintenance Timing Current cycle No. move the cursor to select "5: Status Display. As to the waste chamber. Sysmex KX-21N Operator’s Manual -. Using [ ] key or [ ] key. *Maintenance* 1:Clean W. the next maintenance period is informed in accordance with the operation cycle No. or date. of each item can be checked by the following procedure: 9 . transducer. the cycle number and the date of the last service are displayed. Cycle No. the message instructing the maintenance is displayed on the screen.Clean 3:Cancel Figure 4-9-3: Scheduled Maintenance Message Screen 4-42 Sysmex KX-21N Operator’s Manual -. It will take approx. At this time.October 1999 . WB Ready 1234567 2567 2567 7567 Cycle No. after cleaning. after cleaning waste chamber Cycle No. turn over the page to display the Status Display screen 2. 15 minutes.MAINTENANCE AND SUPPLIES REPLACEMENT (6) Using [ ] key or [ ] key. • When the power is turn-on and the counter exceeds the predetermined cycle number (or number of days). after cleaning transducer Cycle No. Figure 4-9-2: Status Display Screen 2 NOTE: • Cycle number is the number of operations after the last maintenance. *Scheduled Maint. after cleaning SRV *Status* COUNTER WASTE CHAMBER DETECTOR SRV Change screen with [ ] or [ ]. 2515 Date last serviced 1/12/1999 1:Exec.* Clean the Waste Chamber. . 5-1 1..........................1 X Control.3 QC Chart Screen ............... INTRODUCTION .................................5-31 4........................ 5-5 2.....................5-27 EXTERNAL OUTPUT ...............5-26 DELETION .....................................1 QC Analysis Procedure Flow Chart .........................5-35 2.............................................................4 Erase All......................1 Printing to Printer .....................5-10 2.... 4............................................8 Exit from QC Control Program....................................................................................................5-19 2.....6 Execute X Control .... 3...........................................................................3 Select QC File ...............................7 Execute L-J Control......2 Output to Host Computer .......................................... 5-2 QC ANALYSIS PROCEDURE.......October 1999 ................. Sysmex KX-21N Operator’s Manual -................................... 5-6 2.................................... 5-4 2.................. 5-7 2........2 Execute QC Program ..... 5-1 1..........2 Levy-Jennings Control (L-J) ...........................................CHAPTER 5 QUALITY CONTROL 1....................................5 Set TARGET/LIMIT Values..............5-31 4..................................................................... 5-1 1........................................ 5-4 2.... 5-8 2................... Quality control material should be run after component replacement or after a service call. NOTE: • Selection of the one of the two methods can be performed using QC method in the QC Settings program. This product is supplied with three control levels. 1 .October 1999 5-1 ." Sysmex KX-21N Operator’s Manual -. 1 X Control In X control. Refer to "Chapter 10. INTRODUCTION Quality Control checks are performed to monitor an instrument’s performance over time.QUALITY CONTROL 1. 1 . control blood is analyzed twice and the mean of the two is used to evaluate analyzer performance. 2 Levy-Jennings Control (L-J) The L-J control uses the data from a single control blood analysis to evaluated analyzer performance. EIGHTCHECK-3WP is the quality control material recommended by Sysmex to monitor the performance of the KX-21N analyzer. The KX-21N has two quality control methods. at least two levels should be run every 8 hours of operation or in accordance to regulations applicable to your laboratory. Section 5: QC Settings. 8 15." and "3: Erase All.No. QC Chart Screen [5/8] Figure 5-1-1: Page Selection in QC Chart Screen Lot. When a new data comes in. QC Chart Screen [7/8] P6.5 15. and display the QC Chart screen.52 4.55) 14.October 1999 .Date (N=30) UL WBC LL UL RBC LL UL HGB LL 31/10 LIMIT DATA (MEAN) 7. QC Chart Screen [6/8] P5. 3 QC Chart Screen When the QC program is executed.30( 15. P1. [ ] key or [ ] key can be used to change over the screen.0 14.3 7. the oldest data is erased. QC Chart Screen [3/8] P8." The menu can be executed using the numeric keys.50 4. The control parameters indicated in the QC Chart are displayed on multiple pages. the QC File List screen appears first.5( Line cursor 1:QC Analyze 2:Settings 3:Erase All Figure 5-1-2: QC Chart Screen 5-2 Sysmex KX-21N Operator’s Manual -. The Menu Display Area displays "1: QC Analyze. Select the QC File used from among that.1 7.0) 8. QC Chart Screen [1/8] P2. QC Chart Screen [8/8] P4.8) 4. QC Chart Screen [2/8] P3. QC Chart Screen [4/8] P7.QUALITY CONTROL 1 .6 7.1( 4. Six QC Files are displayed in the file list.1 [1234567890][07/11/1999] Exp. The QC Chart can display QC data up to the latest 60 points. FILE No.70 4." "2: Settings. In the case of X control. No.QUALITY CONTROL The QC Chart screen displays QC data as shown below: 1 ) FILE No. Control parameter Analysis parameters of control data are displayed on multiple pages: QC Chart screen [1/8]: WBC. NEUT# QC Chart screen [6/8]: RDW-SD. The QC data of the plot shown by the line cursor. RBC. W-LMV 6) 7) 8) 9) LIMIT (UL) The upper control limit. FILE No. Sysmex KX-21N Operator’s Manual -. PLT QC Chart screen [4/8]: LYM%. Target value QC Target value DATA The QC data of the plot specified by the vertical line cursor. RDW-CV QC Chart screen [7/8]: PDW. An analysis value exceeding this limit is a QC error.October 1999 5-3 . the average represents a data. HGB QC Chart screen [2/8]: HCT. MXD#. An analysis value exceeding this limit is a QC error. In the case of X control. Exp. of QC Chart displayed on the screen 2) 3) 4) Lot. Lot number set in the QC File. Data Expiration date set in the QC File. MCH QC Chart screen [3/8]: MCHC. N The number of control data plotted currently. it is the mean value of two consecutive analyses. MXD%. along with analysis date. MPV. P-LCR QC Chart screen [8/8]: W-SMV. LIMIT (LL) The lower control limit. NEUT% QC Chart screen [5/8]: LYM#. MCV. 5) 1 0 ) MEAN The mean of QC data plotted currently 1 1 ) Line Cursor The vertical line cursor can be moved to the right or left using [ ] key or [ ] key. are displayed. QUALITY CONTROL 2.1 QC Analysis Procedure Flow Chart Execute QC program Page 5-5 Select QC File Page 5-6 YES New QC NO Erase All QC Data Page 5-7 Set TARGET Values/ LIMIT Values Page 5-8 Execute X Control Page 5-10 Execute L-J Control Page 5-19 Delete QC Data Page 5-27 External Output Page 5-31 Exit from QC Program Page 5-26 Figure 5-2-1: QC Analysis Procedure Flow Chart 5-4 Sysmex KX-21N Operator’s Manual -.October 1999 . QC ANALYSIS PROCEDURE 2. 1999] : [1234567895][06.1999] : [1234567894][01. 1 2 3 4 5 6 Exp.12.11. The Select Menu screen appears.12.1999] : [1234567892][21.11. move the cursor to select "2: Quality Control. *Quality Control* Lot. Using [ ] key or [ ] key. The QC File List screen appears.No.1999] : [1234567893][28.October 1999 5-5 .QUALITY CONTROL 2 . 2 Execute QC Program (1) (2) (3) Press [SELECT] key in the Ready status.11." Press [ENTER] key.1999] : [1234567891][14.11.Date : [1234567890][07.1999] Figure 5-2-2: QC File List screen Sysmex KX-21N Operator’s Manual -. October 1999 .1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:QC Analyze 2:Settings 31/10 LIMIT DATA (MEAN) 7. and select a QC file to be selected.70 4. (2) Press [ENTER] key. How to Select QC File (1) Using [ ] key or [ ] key to move the cursor on the QC File List screen.8 15. file erasing. settings.5( 3:Erase All Figure 5-2-3: QC Chart Screen 5-6 Sysmex KX-21N Operator’s Manual -. The QC Chart screen for the selected QC file appears.5 15. or HC output. 3 Select QC File This instrument stores six QC Files.0) 8.30( 15.1 7. NOTE: FILE No. • The QC File can be selected directly by inputting file number of the QC File with numeric keys.3 7.1( 4. display the QC Chart screen for a desired file as follows.50 4.QUALITY CONTROL 2 .52 4. • Press [SELECT] key to return from the QC Chart screen to the QC File List screen.55) 14.8) 4. To execute QC analysis.0 14.6 7. Execute Cancel Figure 5-2-5: Second Erase All Confirmation Message (4) Using [ ] key or [ ] key. the control data in the QC File has to be erased. (5) Sysmex KX-21N Operator’s Manual -." [Execute]: Completely erases QC data and returns to the QC Chart screen.October 1999 5-7 . Erase All. [No]: Cancels the erasing of the plot display on the QC Chart screen and returns to the QC Chart screen.QUALITY CONTROL 2 . How to Erase All QC Data (1) Display the QC Chart screen for the QC File you want to erase. use the menu of "3: Erase All" to erase all control data in the QC File. All are erasing. [Cancel]: Cancels QC data erase and returns to the QC Chart screen. OK to erase all? Yes No Figure 5-2-4: Erase All Confirmation Message (3) Using [ ] key or [ ] key. When a control blood lot has changed." [Yes]: Erases the plot display on the QC Chart screen and displays the second Erase All Confirmation message. move the cursor to select "Yes" or "No. 4 Erase All To start quality control newly. For how to select the QC File. (2) Press [3] key to select "3. Press [ENTER] key to execute the selected process. move the cursor to select "Execute" or "Cancel.3: Select QC File in this chapter. refer to Section 2." The Erase All Confirmation message appears. 0 0. you have to set TARGET and LIMIT values for the QC File using "2: Settings" on the menu. 5-8 Sysmex KX-21N Operator’s Manual -.Date WBC RBC HGB HCT MCV MCH MCHC PLT [ ] [ ] TARGET LIMIT 0.0 0. (lot number). FILE No. so scroll the screen with [ ] key or [ ] key. Exp. refer to Section 2. Figure 5-2-6: QC File Setting Screen (3) Move the cursor with [ ] key or [ ] key.No. and select Lot.0 0.0 0. Also.0 0.0 0 0 ×1 03/µL ×1 06/µL g/dL % fL pg g/dL ×1 03/µL Press [SELECT] to exit. For how to select the QC File. How to Set QC File (1) Display the QC Chart screen for the QC File you want to set. NOTE: • There are 21 control parameters. but all the control parameters cannot be listed in one screen.00 0.0 0.QUALITY CONTROL 2 .0 0.Date (expiration date) or the control parameter. the lot number and the expiration date of the control blood can be registered at the same time as setting these.00 0. Move the cursor with [ ] key or [ ] key.3: Select QC File in this chapter. (2) Press [2] key to select "2: Settings.October 1999 . and select TARGET or LIMIT in the control parameter.0 0.1 Lot." The QC File Setting screen appears.0 0.0 0. 5 Set TARGET/LIMIT Values Before executing Quality Control anew.0 0.No Exp. For setting the lot number • The Lot number can be input up to 10 digits.. • The contents of settings are also set when [ ] key. The contents of settings are set and the cursor moves to the next item. refer to Chapter 10: INSTRUMENT SETTING. NOTE: (5) Press [ENTER] key.QUALITY CONTROL (4) Enter the set values using the numeric keys. move the cursor to select "Cont.October 1999 5-9 . up to five digits including decimal point can be entered. OK to set? Cont. Sysmex KX-21N Operator’s Manual -. Set Cancel Figure 5-2-7: Setting Confirmation Message (7) Using [ ] key or [ ] key. processing which judging the date in the program is not carried out. (8) NOTE: • QC chart will be drawn only if the TARGET and LIMIT values are both entered appropriately. [ ] key. [Set]: Updates the settings and returns to the QC Chart screen. • Even if the expiration date is input. The Setting Confirmation message appears. [Cancel]: Cancels the changed settings and returns to the QC Chart screen. • Each time you press [C] key in the middle of entering. NOTE: (6) When settings are completed. one character disappears and the cursor moves to the left. For detail. the lot number can be input with the handy barcode reader (option). press [SELECT] key." "Set. Press [ENTER] key to execute the selected process. • Also. ] key. Section 2: System Setup. For setting the expiration date • The expiration date can be input up to 10 digits.]: Returns to the QC File Setting screen." [Cont. [ or [ ] key is pressed after entering. This is just a memo input for managing the QC File. For setting the control parameter • As a set value." or "Cancel. • The decimal point position is linked to the Unit System established in System Setup. And the setting operation can be continued. (1) Display the QC Chart screen for the QC File in which to enter QC data. • While the X Control Analysis screen is displayed. the Mode Change Sequence is activated to change over to the whole blood mode. 5-10 Sysmex KX-21N Operator’s Manual -. (2) Press [1] key to select "1: QC Analyze.October 1999 .1 X1 WBC RBC HGB HCT MCV MCH MCHC PLT QC Ready X2 X Judgement Figure 5-2-8: X Control Analysis Screen NOTE: • QC analysis is made in the whole blood mode.. After completion of work. etc. When the pre-diluted mode is selected as analysis mode. NOTE: • QC analysis is executed by control method ( X control or L-J control) set in QC Settings. wash the hands with disinfectant. refer to Chapter 10." The X Control Analysis screen appears. (3) Confirm that "Ready" is displayed for QC analysis. the QC File cannot be changed. FILE No. For setting procedures. If your hands are contaminated by blood. Section 5: QC Settings. always wear rubber gloves. refer to Chapter 2. infection of pathogenic bacteria can occur. For how to select the QC File. 6 Execute X Control The X control method for analyzing control blood is described here.QUALITY CONTROL 2 .3: Select QC File in this chapter. WARNING • In analyzing control blood. remove the control blood container.October 1999 5-11 .beep.QUALITY CONTROL (4) Mix control blood sufficiently.and "Analyzing" is displayed on the X Control Analysis screen. Sysmex KX-21N Operator’s Manual -. beep. Start switch Figure 5-2-11: Pressing the Start Switch (7) When the buzzer sounds two times . Then. automatic analysis is executed. . 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. Figure 5-2-9: Mixing the Control Blood (5) Remove the cap while taking care not to allow blood to scatter. NOTE: • The sample probe is automatically rinsed.1 QC Rinsing Figure 5-2-12: X Control Analysis Screen • While the screen is displaying "Aspirating. Take care not to bend the sample probe." keep holding the control blood container in the aforementioned status. the rinse cup lowers.October 1999 . so there is no need to wipe it clean.1 QC Analyzing (Rinsing) FILE No.QUALITY CONTROL The screens from the start to the end of analysis are as shown below.1 QC Aspirating (Analyzing) FILE No. beep" and "Analyzing" appears on the screen. lower it straight down. • To remove the container. correct analysis may not be obtained. Remove the control blood container by that time.1 QC Ready (Aspirating) FILE No. (Ready) FILE No. CAUTION CAUTION: • Several seconds after the buzzer sounds "beep. 5-12 Sysmex KX-21N Operator’s Manual -. If the container is removed during its display. 4% 03/µL 206×1 8.1 No.QC01-1 RBC PLT PLT PDW MPV P-LCR Accept Data? 1:OK 2:NG 3:Print RBC MCV RDW-SD RDW-CV QC 31/12 10:02 4.1 WBC RBC HGB HCT MCV MCH MCHC PLT X1 7.1 No.4% 2.4% 59.9 206 QC X2 X Judgement Accept Data? 1:OK 2:NG 3:Print Figure 5-2-14: P1.8% Figure 5-2-16: P3. WBC Screen FILE No. WBC Screen P3.7 40. RBC/PLT Screen Sysmex KX-21N Operator’s Manual -.3 4. The analysis result comprises three screens which can be changed over by pressing [ ] key or [ ] key.2 80.October 1999 5-13 .52×1 06/µL 80. P1.1fL 27.8 36.3×1 27.52 14. RBC/PLT Screen Figure 5-2-13: Page Selection in QC Analysis Result Screen FILE No.1 32.QC01-1 WBC WBC LYM% MXD% NEUT% LYM# MXD# NEUT# W-SMV W-LMV 2:NG QC 31/12 10:02 03/µL 7.2% 13. the 1st time analysis result is displayed.0×1 03/µL 03/µL 4.1fL 14.4fL 3:Print Accept Data? 1:OK Figure 5-2-15: P2.4fL 11. CBC8 Parameter Screen FILE No.3fL 172.3fL 9. CBC8 Parameter Screen P2.0×1 03/µL 1.3×1 56.QUALITY CONTROL (8) Under the "X1" column on the Analysis Result screen. 9 206 ×1 03/µL ×1 06/µL g/dL % fL Pg g/dL ×1 03/µL WBC [fl] LYM% MXD% NEUT% LYM# MXD# NEUT# W-SMV W-LMV 27.7 40. Press [3] key and select "3: Print" to print the contents of analysis result on the built-in printer.4 % % % ×1 03/µL ×1 03/µL ×1 03/µL fL fL RBC [fl] RDW-SD RDW-CV 27.8 % Figure 5-2-17: Example of Analysis Result Printing NOTE: • Print of analysis result is valid until the data is set. 5-14 Sysmex KX-21N Operator’s Manual -. Press [2] key to reject.2 13. If the data is set by pressing [1] key or [2] key.1 32.1 fL 14.4 59. press [1] key to confirm.0 4.3 fL 9.4 % PLT [fl] PDW MPV P-LCR 8. analysis result cannot be printed.2 80.8 36.4 2.0 1.4 fL 11.October 1999 .3 4. Date Time Mode WBC RBC HGB HCT MCV MCH MCHC PLT QC01-1 31/10/1999 10:02 QC 7.QUALITY CONTROL If the data is acceptable. • This print format cannot be changed since it is the special format for QC analysis.3 56.3 172. No.52 14. Press [HELP] key and perform the error recovery process. The data confirmation message is displayed and you are asked to decide whether or not to accept the analysis result as QC data. And the system remains to be ready for another 1st time analysis. CAUTION: • When an error occurs during QC analysis. When you press [SELECT] key before setting the 1st QC data. the (3) . For the error recovery process. the mean values of the 1st and the 2nd analyses under " X .QUALITY CONTROL (9) Set the data using [1] key or [2] key.October 1999 5-15 . and returns to the Analysis screen. [1: OK]: Accepts analysis result as the 1st time QC data. the QC Cancel Confirmation message is displayed. Press [ENTER] key to execute the selected process. move the cursor to select "Yes" or "No. [2: NG]: Cancels the 1st time analysis result.(7) procedure is repeated for the 2nd analysis. (10) When the 1st analysis data is accepted." and the comparison result with control limits under the "Judgment" column. refer to Chapter 7: TROUBLESHOOTING. error message is displayed in the system status area. can be changed over using [ ] key or [ ] key. OK to cancel? Yes No Figure 5-2-18: QC Cancel Confirmation Message Using [ ] key or [ ] key. And the system turns to be ready for the 2nd analysis. Sysmex KX-21N Operator’s Manual -. (11) The 2nd analysis result is displayed under "X2" on the Analysis Result screen. [No]: Returns to the QC Analysis screen and allows continuous QC analysis. exits from QC program. The Analysis Result screen." [Yes]: Rejects analysis result. as in the 1st analysis. 1 208 Judgement Accept Data? 1:OK 2:NG 3:Print 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. refer to Chapter 7: TROUBLESHOOTING.3 32.4 4.1 109 QC Error X 7.3 4.8 36.4 4.7 34.October 1999 .52 14.52 14.3 209 X 7.8 42. [1: OK]: QC data is accepted and the plot is entered to the QC Chart. Press [HELP] key and perform the error recovery process. And the system remains to be ready for the 2nd analysis again.8 106 QC X2 7.7 40.7 41.7 34.2 80.9 206 QC X2 7.49 14.7 43.5 94.9 79. 5-16 Sysmex KX-21N Operator’s Manual -.7 32.8 32.5 4.7 41. CAUTION: • When an error occurs during QC analysis.9 32. while the alarm sounds and the QC error message appears.49 14. This QC data (mean) is kept in the stored data also.1 WBC RBC HGB HCT MCV MCH MCHC PLT X1 7.3 4.51 14.6 79.0 95.7 35.1 WBC RBC HGB HCT MCV MCH MCHC PLT X1 7. For the error recovery process. FILE No. [2: NG]: Cancels the 2nd analysis result.5 4. the error message appears in the system status area.8 94.5 108 Judgement + + - 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.8 35.1 32.7 34.8 42.QUALITY CONTROL FILE No.51 14.0 32. Date Time Mode WBC RBC HGB HCT MCV MCH MCHC PLT LYM% MXD% NEUT% LYM# MXD# NEUT# W-SMV W-LMV RDW-SD RDW-CV PDW MPV P-LCR QC01-1 31/10/1999 10:02 QC 7.0 4. No.4 8.0 1.8 ×1 03/µL ×1 06/µL g/dL % fL Pg g/dL ×1 03/µL % % % ×1 03/µL ×1 03/µL ×1 03/µL fL fL fL % fL fL % Figure 5-2-21: Example of Printing NOTE: • Printing in QC settings is valid only when the "Built-in Printer" is selected.51 14.October 1999 5-17 . Sysmex KX-21N Operator’s Manual -.7 32.8 35.9 79.4 4. Section 5: QC Settings. For detail.1 208 27. • This print format cannot be changed since it is the special format for QC analysis.3 9. refer to Chapter 10.4 2.4 59.4 27.QUALITY CONTROL (13) The set data (mean) is printed on the built-in printer. • As to the host output format.1 14.7 41.2 13.4 11. (14) The set data (mean) is output to the host computer. Section 5: QC Settings.3 172. NOTE: • Transmission to the host is valid only when the "Host Output" is selected.3 56. For detail. refer to Appendix B: Technical Information. refer to Chapter 10. exists from the QC program. Press [ENTER] key to execute the selected process.October 1999 . 5-18 Sysmex KX-21N Operator’s Manual -. move the cursor to select "Yes" or "No. and returns to the Analysis screen." [Yes]: Rejects analysis result. the QC Cancel Confirmation message appears. [No]: Returns to the QC Analysis screen and allows continuous QC analysis. OK to cancel? Yes No Figure 5-2-22: QC Cancel Confirmation Message Using [ ] key or [ ] key.QUALITY CONTROL When you press [SELECT] key before setting the 2nd QC data. NOTE: • QC analysis is executed by control method ( X control or L-J control) set in QC Settings. refer to Chapter 10.3: Select QC File in this chapter. For how to select the QC File.October 1999 5-19 . (3) Confirm that "Ready" is displayed for QC analysis. If your hands are contaminated by blood. After completion of work. For setting procedures. FILE No.QUALITY CONTROL 2 . Sysmex KX-21N Operator’s Manual -." The L-J Control Analysis screen appears. Section 5: QC Settings. (2) Press [1] key to select "1: QC Analyze. When the pre-diluted mode is selected as analysis mode.. always wear rubber gloves.1 WBC RBC HGB HCT MCV MCH MCHC PLT QC Ready Data Judgement Figure 5-2-23: L-J Control Analysis Screen NOTE: • QC analysis is made in the whole blood mode. wash the hands with disinfectant. the QC File cannot be changed. (1) Display the QC Chart screen for the QC File in which to enter QC data. 7 Execute L-J Control How to analyze control blood by L-J control is described here. refer to Chapter 2. the Mode Change Sequence is activated to change over to the whole blood mode. • While the L-J Control Analysis screen is displayed. etc. infection of pathogenic bacteria can occur. WARNING • In analyzing control blood. 5-20 Sysmex KX-21N Operator’s Manual -.beep. Then. remove the control blood container. 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. Figure 5-2-24: Mixing the Control Blood (5) Remove the cap while taking care not to allow blood to scatter. . Start switch Figure 5-2-26: Pressing the Start Switch (7) When the buzzer sounds two times .QUALITY CONTROL (4) Mix control blood sufficiently. beep.and "Analyzing" is displayed on the L-J Control Analysis screen. automatic analysis is executed.October 1999 . QUALITY CONTROL The screens from the start to the end of analysis are as shown below. NOTE: • The sample probe is automatically rinsed. Sysmex KX-21N Operator’s Manual -. (Ready) FILE No. Remove the control blood container by that time. so there is no need to wipe it clean.1 QC Analyzing (Rinsing) FILE No. the rinse cup lowers. beep" and "Analyzing" appears on the screen. lower it straight down. • To remove the container. Take care not to bend the sample probe.October 1999 5-21 ." keep holding the control blood container in the aforementioned status. If the container is removed during its display. correct analysis may not be obtained.1 QC Ready (Aspirating) FILE No.1 QC Aspirating (Analyzing) FILE No. CAUTION CAUTION: • Several seconds after the buzzer sounds "beep.1 QC Rinsing Figure 5-2-27: L-J Control Analysis Screen • While the screen is displaying "Aspirating. 3×1 27.8 36.2% 13. WBC Screen FILE No.October 1999 .2 80.4fL 3:Print Accept Data? 1:OK Figure 5-2-30: P2.3×1 56.8% Figure 5-2-31: P3. The analysis result comprises three screens which can be changed over by pressing [ ] key or [ ] key.9 206 Judgement Figure 5-2-29: P1. WBC Screen P3.1fL 14.1 No.QC01-1 WBC WBC LYM% MXD% NEUT% LYM# MXD# NEUT# W-SMV W-LMV 2:NG QC 31/10 10:02 03/µL 7.3 4. CBC8 Parameter Screen P2. RBC/PLT Screen Figure 5-2-28: Page Selection in QC Analysis Result Screen FILE No.7 40.0×1 03/µL 1.1fL 27.1 No.1 WBC RBC HGB HCT MCV MCH MCHC PLT Accept Data? 1:OK 2:NG 3:Print QC Data 7.52 14.3fL 9.52×1 80. CBC8 Parameter Screen FILE No.QUALITY CONTROL (8) Analysis result is given under the "Data" column on the Analysis Result screen and comparison result with QC limits under the "Judgment" column.0×1 03/µL 03/µL 4.4% 03/µL 206×1 8.1 32. RBC/PLT Screen 5-22 Sysmex KX-21N Operator’s Manual -.4% 59.QC01-1 RBC PLT PLT PDW MPV P-LCR Accept Data? 1:OK 2:NG 3:Print RBC MCV RDW-SD RDW-CV QC 31/10 10:02 06/µL 4.4fL 11.3fL 172.4% 2. P1. Press [2] key to reject.1 WBC RBC HGB HCT MCV MCH MCHC PLT QC Data 7. Sysmex KX-21N Operator’s Manual -.7 34.7 43.QUALITY CONTROL As to those parameters whose analysis fell beyond control limits. + or − is displayed under the "Judgment" column. Press [3] key and select "3: Print" to print the contents of analysis result on the built-in printer. press [1] key to confirm.6 32. FILE No.0 95.5 4.October 1999 5-23 . while the alarm sounds with the QC error message displayed.1 109 QC Error Judgement + + - Accept Data? 1:OK 2:NG 3:Print Figure 5-2-32: QC Error Message Screen If the data is acceptable.49 14. 3 4.1 32.QUALITY CONTROL No.9 206 ×1 03/µL ×1 06/µL g/dL % fL Pg g/dL ×1 03/µL WBC [fl] LYM% MXD% NEUT% LYM# MXD# NEUT# W-SMV W-LMV 27. If the data is set by pressing [1] key or [2] key.4 % % % ×1 03/µL ×1 03/µL ×1 03/µL fL fL RBC [fl] RDW-SD RDW-CV 27.3 172.0 4. and the system remains to be ready for another analysis.52 14.3 56.4 fL 11.4 2.3 fL 9.8 36. Date Time Mode WBC RBC HGB HCT MCV MCH MCHC PLT QC01-1 31/10/1999 10:02 QC 7.October 1999 5-24 . analysis result cannot be printed.1 fL 14.0 1. (9) Set the data using [1] key or [2] key.4 59. • This print format cannot be changed since it is the special format for QC analysis.7 40. and the plot is entered to the QC Chart.2 13.4 % PLT [fl] PDW MPV P-LCR 8. Sysmex KX-21N Operator’s Manual -.2 80.8 % Figure 5-2-33: Example of Analysis Result Printing CAUTION: • Print of analysis result is valid until the data is set. [1: OK]: Sets QC data. [2: NG]: Cancels the analysis result. This QC data is kept in the stored data. refer to Chapter 10.4 4.8 35. Sysmex KX-21N Operator’s Manual -.8 ×1 03/µL ×1 06/µL g/dL % fL Pg g/dL ×1 03/µL % % % ×1 03/µL ×1 03/µL ×1 03/µL fL fL fL % fL fL % Figure 5-2-34: Example of Printing NOTE: • Printing in QC settings is valid only when the "Built-in Printer" is selected. For detail. error message is displayed in the system status area.4 2.2 13.51 14.4 8. No. Press [HELP] key and perform the error recovery process. refer to Appendix B: Technical Information. Section 5: QC Settings.QUALITY CONTROL CAUTION: • When an error occurs during QC analysis. Section 5: QC Settings. refer to Chapter 10. • This print format cannot be changed since it is the special format for QC analysis. NOTE: • Transmission to the host is valid only when the "Host Output" is selected.9 79. For the error recovery process. refer to Chapter 7: TROUBLESHOOTING.7 32. For detail.3 56.4 59.7 41.0 4.1 14. Date Time Mode WBC RBC HGB HCT MCV MCH MCHC PLT LYM% MXD% NEUT% LYM# MXD# NEUT# W-SMV W-LMV RDW-SD RDW-CV PDW MPV P-LCR QC01-1 31/10/1999 10:02 QC 7.4 11.1 208 27.0 1. (10) The set data is printed on the built-in printer. (11) The set data is output to the host computer. • As to the host output format.October 1999 5-25 .4 27.3 9.3 172. move the cursor to select "Yes" or "No.October 1999 . and analysis mode on the Analysis screen return to those displayed before execution of the QC program. 8 Exit from QC Control Program (1) (2) Press [SELECT] key on the QC Chart screen. The Analysis screen returns.QUALITY CONTROL When you press [SELECT] key before setting the QC data. 5-26 Sysmex KX-21N Operator’s Manual -. the QC Cancel Confirmation message appears. OK to cancel? Yes No Figure 5-2-35: QC Cancel Confirmation Message Using [ ] key or [ ] key. Press [SELECT] key. and returns to the Analysis screen. [No]: Returns to the QC Analysis screen and allows continuous QC analysis. The QC File List screen returns." [Yes]: Rejects analysis result. exist from the QC program. 2 . NOTE: • The sample No. Press [ENTER] key to execute the selected process. 0) 8. Figure 5-3-2: QC Chart Screen (At Data Selection) Sysmex KX-21N Operator’s Manual -.8 15.0 14.55) 14.8 15.5 15.3 7. and the line cursor returns to dotted line and the menu in the Menu Display Area change to the original status.October 1999 5-27 .5( 3:Erase All Figure 5-3-1: QC Chart Screen (3) Press [ENTER] key.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:Delete 2:Output 31/10 LIMIT DATA (MEAN) 7.55) 14. FILE No. DELETION This menu can delete one data or the range specified data of QC data in the line cursor position." "3: RangeSpec." "2: Output.1( 4.3: Select QC File in this chapter.52 4.6 7. (2) Using [ ] key or [ ] key.5 15.30( 15. 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.50 4.6 7.30( 15. refer to Chapter 2. NOTE: • Press [SELECT] key.1 7. The line cursor changes from dotted line to solid line. FILE No.".70 4. and the menu in the Menu Display Area changes over to "1: Delete.8) 4. For how to select QC file. move the line cursor to the position of the data to be deleted.50 4.3 7.1 7.52 4.70 4.1( 4.QUALITY CONTROL 3.5( 3:RangeSpec.0) 8.0 14. • The line cursor that has changed to solid line cannot be moved.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:QC Analyze 2:Settings 31/10 LIMIT DATA (MEAN) 7.8) 4. QUALITY CONTROL (4) Press [1] key to select "1: Delete.3 7.50 4.October 1999 .6 7.0 14.8) 4. move the line cursor to the end of the data within the deleted range.1( 4." [Yes]: Deletes QC data of the plot shown by the line cursor and returns the line cursor to the dotted line.55) 14.5 15.5( 3:Erase All Figure 5-3-4: QC Chart Screen 5-28 Sysmex KX-21N Operator’s Manual -. For how to select QC file.0) 8.52 4. FILE No. OK to Delete? Yes No Figure 5-3-3: Deletion Confirmation Message (5) Using [ ] key or [ ] key.8 15. (2) Using [ ] key or [ ] key." The Deletion confirmation message appears.70 4.1 7. (6) 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. move the cursor to select "Yes" or "No.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:QC Analyze 2:Settings 31/10 LIMIT DATA (MEAN) 7. Press [ENTER] key to execute the selected process.30( 15. [No]: Cancels deletion of QC data and returns the line cursor to the dotted line.3: Select QC File in this chapter. refer to Chapter 2. Sysmex KX-21N Operator’s Manual -.".6 7. move the line cursor to the other end of the data within the deleted range." "3: RangeSpec.3 7. FILE No.70 4.0 14.8) 4.70 4.0) 8.". Figure 5-3-5: QC Chart Screen (At Data Selection) (4) (5) Press [3] key to select "3: RangeSpec. and the menu in the Menu Display Area changes over to "1: Delete. Figure 5-3-6: QC Chart Screen (At Data Range Specification) (6) Press [ENTER] key.1( 4.1 7.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:Delete 2:Output 31/10 LIMIT DATA (MEAN) 7.5( 3:RangeSpec.0 14. NOTE: • Press [SELECT] key.52 4.30( 15.30( 15.55) 14.0) 8.8 15. Move the line cursor of the dotted line for range specification of the other end.8 15.5 15.October 1999 5-29 . Using [ ] key or [ ] key.8) 4. FILE No.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:Delete 2:Output 31/10 LIMIT DATA (MEAN) 7." "2: Output. The line cursor changes from dotted line to solid line.6 7.5( 3:RangeSpec.50 4.52 4. and the line cursor returns to dotted line and the menu in the Menu Display Area change to the original status.50 4.5 15.3 7.1( 4.55) 14.QUALITY CONTROL (3) Press [ENTER] key.1 7. The line cursor changes from dotted line to solid line. move the cursor to select "Yes" or "No. OK to Delete? Yes No Figure 5-3-7: Deletion Confirmation Message (8) Using [ ] key or [ ] key.QUALITY CONTROL (7) Press [1] key to select "1: Delete.October 1999 ." [Yes]: Deletes QC data of the plot shown by two line cursors and returns the line cursor to the dotted line. (9) 5-30 Sysmex KX-21N Operator’s Manual -. [No]: Cancels deletion of QC data and returns the line cursor to the dotted line. Press [ENTER] key to execute the selected process." The Deletion confirmation message appears. (2) Using [ ] key or [ ] key. FILE No.1( 4.50 4. EXTERNAL OUTPUT Using this menu.0) 8.55) 14. 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.October 1999 5-31 .5( 3:Erase All Figure 5-4-1: QC Chart Screen Sysmex KX-21N Operator’s Manual -. QC data in the line cursor position can be printed out from the builtin/external printer or output to the host computer.QUALITY CONTROL 4. move the line cursor to the position of the data to be printed. For how to select QC file.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:QC Analyze 2:Settings 31/10 LIMIT DATA (MEAN) 7.8) 4.6 7. (The external printer is an option).8 15.3: Select QC File in this chapter.1 7. 4 . refer to Chapter 2.52 4.30( 15.3 7.5 15.70 4.0 14. 6 7.55) 14.50 4."." "3: RangeSpec.30( 15.October 1999 . Figure 5-4-3: QC Chart Screen (At Data Range Specification) (6) Press [ENTER] key. Using [ ] key or [ ] key. move the line cursor to the other end of the data within the printing range. FILE No.0) 8.5 15.70 4. 5-32 Sysmex KX-21N Operator’s Manual -.52 4.5 15.0 14. The line cursor changes from dotted line to solid line.52 4.0 14. NOTE: • Press [SELECT] key.55) 14. The line cursor changes from dotted line to solid line.8 15. Figure 5-4-2: QC Chart Screen (At Data Selection) (4) (5) Press [3] key to select "3: RangeSpec.8) 4.".1( 4.8 15.1( 4.3 7.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:Delete 2:Output 31/10 LIMIT DATA (MEAN) 7.70 4." "2: Output.QUALITY CONTROL (3) Press [ENTER] key. and the menu in the Menu Display Area changes over to "1: Delete.50 4. • The line cursor that has changed to solid line cannot be moved.3 7.6 7.1 7.1 7. FILE No.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:Delete 2:Output 31/10 LIMIT DATA (MEAN) 7.0) 8.5( 3:RangeSpec.30( 15. Move the line cursor of the dotted line for range specification of the other end.5( 3:RangeSpec.8) 4. and the line cursor returns to dotted line and the menu in the Menu Display Area change to the original status. 8 36. [5: IP]: The built-in printer starts printing the QC data of the plot which the line cursor shows.7 40. [4: LP]: The graphic printer starts list printing the QC data of the plot which the line cursor shows. Date Time Mode WBC RBC HGB HCT MCV MCH MCHC PLT QC01-01 File No.2: Output to Host Computer in this chapter.October 1999 5-33 ." Contents of Print • Contents of print with built-in printer No. this can be selected. and the print will be interrupted when you select this. and press [ENTER] key." The pop-up menu to select the output destination will appear. [7: Cancel]: When two or more analysis data are printed. and the menus of the menu display area returns to "1: QC Analyze". 31/10/1999 Date Analyzed 10:02 Time Analyzed QC 7. "2: Settings" and "3: Erase All.1 32. the line cursor returns to the dotted line.3 4. [3: GP]: The graphic printer starts graphic printing the QC data of the plot which the line cursor shows.52 14.9 206 ×1 03/µL ×1 06/µL Analysis Mode g/dL % fL Pg g/dL ×1 03/µL Figure 5-4-5: Contents of print with built-in printer Sysmex KX-21N Operator’s Manual -.QUALITY CONTROL (7) Press [2] key to select "2: Output. When the print to the printer is completed. [2: DP]: This cannot be selected. 1:Host 2:DP 3:GP 4:LP 5:IP 6:IP Feed 7:Cancel Figure 5-4-4: Pop-up Menu (8) Using [ ] key or [ ] key to move the cursor to the desired printer. [6:IP Feed]: Carries out the paper feed of the built-in printer. [1: Host]: Output the data to the host computer.2 80. Refer to 4. 70 4.55 4.8 7.50 4. 1) 2) 3) File No.4: External Output. of QC file is printed.October 1999 .[1234567890] Exp.11.. .0 14.5 15.1999] Target/Limit UL WBC LL UL PBC LL UL HGB LL 8. Section 3.1 Lot. Date/Time Analyzed Printed is the date and time when analysis result was obtained. Refer to Chapter 3.52 0 7.1 7. 5-34 Sysmex KX-21N Operator’s Manual -. Analysis Mode In the case of QC data.Date[07.. File No.30/10/1999(N=60) 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.0 15.3 0 Mean SD CV% page( 1) 7/10/1999 .1 4.0 14. "QC" is printed..30 15.No.6 7.8 0 4.QUALITY CONTROL • Contents of graphic print with graphic printer Print Date 31/10/1999 Print Time 10:26 File No. 0) 8.5 15.1( 4.1 7.6 7.3: Select QC File in this chapter. 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. refer to Chapter 2.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:QC Analyze 2:Settings 31/10 LIMIT DATA (MEAN) 7.8) 4.55) 14.5( 3:Erase All Figure 5-4-7: QC Chart Screen Sysmex KX-21N Operator’s Manual -.30( 15. 2 Output to Host Computer Using this menu.50 4.70 4. FILE No. For how to select QC file.October 1999 5-35 .0 14. (2) Using [ ] key or [ ] key.8 15.52 4. move the line cursor to the position of the data you want to output to HC.3 7.QUALITY CONTROL 4 . QUALITY CONTROL (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. FILE No.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:Delete 2:Output 31/10 LIMIT DATA (MEAN) 7.3 7.8) 4.52 4.55) 14.8 15.0) 8.1 7.6 7.1( 4.70 4.50 4.30( 15.5 15.0 14.5( 3:RangeSpec. Figure 5-4-8: QC Chart Screen (At Data Selection) (4) (5) Press [3] key to select "3: RangeSpec.". Move the line cursor of the dotted line for range specification of the other end. Using [ ] key or [ ] key, move the line cursor to the other end of the data within the output range. FILE No.1 [1234567890][07/11/1999] (N=30) UL WBC LL UL RBC LL UL HGB LL 1:Delete 2:Output 31/10 LIMIT DATA (MEAN) 7.3 7.8) 4.52 4.55) 14.8 15.0) 8.1 7.6 7.1( 4.70 4.50 4.30( 15.5 15.0 14.5( 3:RangeSpec. 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. 5-36 Sysmex KX-21N Operator’s Manual -- October 1999 QUALITY CONTROL (7) Press [2] key to select "2: Output." The pop-up menu to select the output destination will appear. 1:Host 2:DP 3:GP 4:LP 5:IP 6:IP Feed 7:Cancel 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 -- October 1999 5-37 CHAPTER 6 CALIBRATION 1. INTRODUCTION ................................................................. 6-1 1.1 Calibration Execution Timing.............................................. 6-1 1.2 Samples Used for Calibration ............................................. 6-1 1.3 Reference Values............................................................ 6-1 1.4 Calibration Flow Chart ..................................................... 6-2 AUTOMATIC CALIBRATION.................................................. 6-3 2.1 Executing Automatic Calibration Program ............................... 6-3 2.2 Automatic Calibration Procedure.......................................... 6-4 MANUAL CALIBRATION ...................................................... 6-9 3.1 Calculating Calibration Value.............................................. 6-9 3.2 Manual Calibration Procedure ............................................6-10 CALIBRATION HISTORY PRINT............................................6-13 2. 3. 4. Sysmex KX-21N Operator’s Manual -- October 1999 CALIBRATION 1. INTRODUCTION Calibration is performed to compensate for any inaccuracies of the pneumatic, hydraulic, and electric systems which will affect analysis results. This is very important in maintaining the system accuracy. Calibration is carried out by entering calibration values into the unit. Your Sysmex service representative will perform initial calibration of your unit at installation. After installation, the operator should make periodical calibration and proper quality control to maintain the accuracy. This chapter describes calibration procedure. 1 . 1 Calibration Execution Timing Calibration need not be performed in specified intervals, but when QC data varies with time, HGB and HCT should be calibrated. When abnormal QC data occur as a result of instrument problem, reagent degradation, or deterioration of control blood, however, do not perform calibration. 1 . 2 Samples Used for Calibration For calibration, use five or more samples of fresh normal blood that meets the following conditions: • 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. 1 . 3 Reference Values 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.) Sysmex KX-21N Operator’s Manual -- October 1999 6-1 CALIBRATION 1 . 4 Calibration Flow Chart HGB/HCT calibration start Analyze samples by the reference method to determine reference value (target value). Automatic calibration: 5 samples Manual calibration: Over 5 samples Page 6-1 Automatic calibration Manual calibration Select automatic calibration program. Page 6-3 Analyze in whole blood mode. Page 6-9 Select calibration parameter. 1: HGB 2: HGB and HCT 3: HCT Calculate calibration value. Page 6-4 Select manual calibration program. Page 6-5 Page 6-9 Enter target value. Page 6-10 Analyze in whole blood mode. Enter calibration value. Page 6-6 Page 6-11 Update calibration value. Page 6-8 Update calibration value. Page 6-12 Completion of HGB/HCT calibration 6-2 Sysmex KX-21N Operator’s Manual -- October 1999 CALIBRATION 2. AUTOMATIC CALIBRATION In automatic calibration, five or more fresh, normal blood samples are used for automatic calibration of HGB and HCT values. 2 . 1 Executing Automatic Calibration Program (1) (2) (3) Press [SELECT] key in the Ready status. The Select Menu screen appears. Using [ ] or [ ] key, move the cursor to select "3: Calibration." Press [ENTER] key. The Calibration Menu screen appears. *Calibration* 1:Auto Cal. 2:Manual Cal. 4:Print Rev. History Figure 6-2-1: Calibration Menu Screen (4) (5) Using [ ] or [ ] key, move the cursor to select "1: Auto Cal." Press [ENTER] key. The Automatic Calibration Menu screen appears. *Auto Cal.* 1:HGB 2:HGB/HCT 3:HCT Figure 6-2-2: 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. Sysmex KX-21N Operator’s Manual -- October 1999 6-3 2 Automatic Calibration Procedure 1. *Auto Cal. (1) Selecting Automatic Calibration Parameter Using [ ] or [ ] key.0 New Cal. NOTE: • Each menu can be selected directly by entering a numeral from the numeric keys.CALIBRATION 2 .0 New Cal. 100.(%) Press [SELECT] to Set.(%)100. [2: HGB/HCT]: Calibrates two parameters of HGB and HCT at the same time.(%)100. (2) Press [ENTER] key.0 HCT Data HGB HCT Compensation HGB HCT Figure 6-2-4: HGB/HCT Automatic Calibration Screen 6-4 Sysmex KX-21N Operator’s Manual -.* Target HGB 1 2 3 4 5 Current Cal.October 1999 .(%) Press [SELECT] to Set. Data HGB Compensation HGB Figure 6-2-3: HGB Automatic Calibration Screen *Auto Cal. The Automatic Calibration screen for the selected parameter appears. [3: HCT]: Calibrates HCT alone. move the cursor to select an automatic calibration parameter on the Automatic Calibration Menu Screen: [1: HGB]: Calibrates HGB alone.* Target HGB 1 2 3 4 5 Current Cal. 0 New Cal. enter the HGB or HCT reference values obtained by the reference method in the target column.(%)100.CALIBRATION *Auto Cal.0 Figure 6-2-6: Entering Target Values NOTE: • After entering the 5th target value. Sysmex KX-21N Operator’s Manual -. pressing [ENTER] key does not move the reverse display to the next target column.October 1999 6-5 . Data HCT Compensation HCT Figure 6-2-5: HCT Automatic Calibration Screen 2.5 2 3 4 5 HCT Data HGB HCT Compensation HGB HCT Current Cal. • Press [C] key to delete one letter at a time.(%)100.* Target HCT 1 2 3 4 5 Current Cal. NOTE: (2) Press [ENTER] key to fix the entered value and 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. 100. (1) Entering Target Values Using the numeric keys.(%) Press [SELECT] to Set.* Target HGB 1 12.(%) Press [SELECT] to Set. *Auto Cal.0 New Cal. 0 New Cal. [Cancel]: Cancels automatic calibration and returns to the Analysis screen. the system turns to the Ready status for automatic calibration analysis.(%)100.0 2 13. (5) 3." or "Cancel. move the cursor to select "Cont. OK to set? Cont." [Cont.5 50. Press [ENTER] key to execute the selected process.0 40.]: Returns to the status for entering target values. [Set]: Sets target values and charges to the Sample Analysis Waiting status.5 4 11. Set Cancel Figure 6-2-7: Target Value Setting Confirmation Message (4) Using [ ] or [ ] key.0 45.2 3 13. (1) NOTE: • Automatic calibration analysis is performed in the whole blood mode. The sample being analyzed is indicated by the underline cursor.October 1999 .CALIBRATION (3) When all target values have been entered. And the setting operation can be continued.8 5 15. When the analysis mode is set in the pre-diluted mode. 6-6 Sysmex KX-21N Operator’s Manual -.(%) 100.5 *Auto Cal. press [SELECT] key.0 Figure 6-2-8: Automatic Calibration Screen (Before Analysis) (2) Analyze the samples used for determining the standard value.." "Set.* Current Cal. WB Ready Data Compensation Target HGB HGB HGB HCT HCT HCT 1 12. the mode changeover sequence is activated to switch to the whole blood mode. The Target Value Setting Confirmation message appears. Analysis for Automatic Calibration When the target values are set.0 52.5 51. compensation rate for the sample is not calculated and the analysis result is not used for average compensation rate calculation.2 13.-.0 Figure 6-2-9: Automatic Calibration Screen (After Analysis) CAUTION: • When an error occurs during automatic calibration analysis. then the underline cursor moves to the next sample.2 51.0 45. The result of analysis in which an error has occurred is masked with "---.October 1999 6-7 .6 Current Cal. Sysmex KX-21N Operator’s Manual -.7 43.1 50. average compensation rate is automatically calculated and displayed at the bottom of the compensation column. analysis result appears in the data column and compensation rate in the compensation column. *Auto Cal.8 52.5 4 11.5 2 13. • If "0" is input to the target value. either.* Target HGB 1 12.0 48.7 103.0 95.5 WB Ready Data Compensation HGB HGB HCT HCT 13.(%)100.(%) 103.2 104. the error message appears in the system status display area.0 HCT 50.0 14." which is not calculated for compensation rate and not used for average compensation rate calculation.0 New Cal.4 100. either.CALIBRATION (3) After completion of analysis.0 96.9 103.9 94. Upon completion of more than one sample.5 40.0 95.0 3 13.0 5 15. Change? Yes No Figure 6-2-10: Calibration Value Change Confirmation Message NOTE: • The new compensation value is calculated as follows: New compensation = Current compensation value (%) × Average compensation rate (%) value (%) 100 • When the compensation rate exceeds the following range. move the cursor to select "YES" or "NO. (2) Using [ ] or [ ]. press [SELECT] key. "Calibration Error" is displayed and the Calibration Value Change Confirmation message does not appear. (1) Updating Calibration Value When all analyses are finished.* Calibration Error Figure 6-3-11: Calibration Error Message About calibration errors.October 1999 . refer to Chapter 7: TROUBLESHOOTING. (3) 6-8 Sysmex KX-21N Operator’s Manual -. Average compensation rate > 105% Average compensation rate < 95% New compensation value > 120% New compensation value < 80% *Auto Cal.CALIBRATION 4. New compensation values will be calculated and the Calibration Value Change Confirmation message will appear. [NO] : Does not update the calibration value and returns to the Analysis screen. Press [ENTER] key to execute the selected process." [YES] : Updates the calibration value and returns to the Analysis screen. calculated calibration value can be entered using the numeric keys.65 .7% 15. MANUAL CALIBRATION In manual calibration. = .6 g/dL Average of HGB values gained by this instrument = 15.5 g/dL Previous calibration value of HGB = 100. by the reference method and average HGB and HCT values. When there is a difference between data gained by analysis with this instrument and the reference value gained by the reference method.7%.0% 100. 100. Gently mix the same samples sufficiently and analyze them in the whole blood mode. each three times. use the following formula to calculate the new calibration value: Average of values gained by reference method New calibration = Previous × value calibration value Average of values gained by this instrument [Example] Average of HGB values gained by the reference method = 15. This means that the calibration value increased 0.7%.0 × 15.6 = 100. Sysmex KX-21N Operator’s Manual -. the new calibration value of HGB needs to be set at 100.CALIBRATION 3.October 1999 6-9 . 3 .5 Therefore. 1 Calculating Calibration Value (1) (2) (3) Analyze more than five samples. CALIBRATION 3 . 2 Manual Calibration Procedure (1) (2) (3) Press [SELECT] key in the Ready status. The Select Menu screen appears. Using [ ] or [ ] key, move the cursor to select "3: Calibration." Press [ENTER] key. The Calibration Menu screen appears. *Calibration* 1:Auto Cal. 2:Manual Cal. 4:Print Rev. History Figure 6-3-1: Calibration Menu Screen (4) (5) Using [ ] or [ ] key, move the cursor to select "2: Manual Cal." Press [ENTER] key. The Manual Calibration screen appears. *Manual Cal.* HGB HCT 100.0 100.0 Press [SELECT] to exit. Figure 6-3-2: Manual Calibration Screen NOTE: • Each menu can be selected directly by entering a numeral from the numeric keys. 6-10 Sysmex KX-21N Operator’s Manual -- October 1999 CALIBRATION 1. (1) (2) Entering Calibration Value Using [ ] or [ ] key, move the cursor to select "HGB" or "HCT." 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. *Manual Cal.* HGB HCT 100.7 100.0 Press [SELECT] to exit. Figure 6-3-3: 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. Sysmex KX-21N Operator’s Manual -- October 1999 6-11 CALIBRATION 2. (1) Updating Calibration Value When all calibration values are entered, press [SELECT] key. The Calibration Value Change Confirmation message appears. Change? Yes No Figure 6-3-4: 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 X 100 Average of values gained by this instrument Compensation rate > 105% Compensation rate < 95% New compensation value > 120% New compensation value < 80% *Manual Cal.* Calibration Error Figure 6-3-5: 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. Press [ENTER] key to execute the selected process. (3) 6-12 Sysmex KX-21N Operator’s Manual -- October 1999 CALIBRATION 4. 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) (3) Using [ ] or [ ] key, move the cursor to select "3: Calibration." Press [ENTER] key. The Calibration Menu screen appears. *Calibration* 1:Auto Cal. 2:Manual Cal. 4:Print Rev. History Figure 6-4-1: Calibration Menu Screen (4) (5) Using [ ] or [ ] key, move the cursor to select "4: Print Rev. History." Press [ENTER] key. The built-in printer prints the calibration history. Date Time 10/31/1999 10:23 Print Example *Cal.History* Date 10/29/1999 Time 08:23 HGB 95.6 HCT 103.4 Date Time HGB HCT 10/30/1999 08:23 99.3 101.2 . . . . Figure 6-4-2: Calibration History Print Sysmex KX-21N Operator’s Manual -- October 1999 6-13 CHAPTER 7 TROUBLESHOOTING 1. 2. INTRODUCTION................................................................. 7-1 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 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 STATUS DISPLAY............................................................. 7-34 ERROR HISTORY PRINT .................................................... 7-36 PROGRAM VERSION ......................................................... 7-37 3. 4. 5. 6. Sysmex KX-21N Operator’s Manual -- October 1999 TROUBLESHOOTING 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. WARNING • 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. Sysmex KX-21N Operator’s Manual -- October 1999 7-1 nothing is displayed and "beep" keeps sounding.. 6. Fluid leaks from the unit.TROUBLESHOOTING 2. 1. The screen displays "PU Sleeping" message and no key entry is accepted. Turn OFF the power. 7-2 Sysmex KX-21N Operator’s Manual -. Section 5. Data has error. To return the instrument to the ready status. 5.2: Replace Fuse. conduct the maintenance below: Chapter 4. and then the [Start] switch. If fluid leakage persists after turning ON the power. WARNING • When operating. etc. • Isn't LCD brightness properly adjusted? Refer to Chapter 1. Section 8. 4. Turning the power ON does not start the unit. press the [SELECT] key to return to the analysis result screen. WHEN YOU SUSPECT A TROUBLE • Is the power cord connected securely? • Isn't the fuse blown? Refer to Chapter 4.3: LCD Brightness Adjustment. 2) TROUBLESHOOTING Cause and action for each trouble are described for respective error message. wash hands with disinfectant. • Is the power supplied to AC outlet? • There is a possibility that memory error has occurred. Section 8. An error occurs. contact your Sysmex service representative. infection of bacteria can result. After completion of work.2: Clean Transducer Chapter 4. If your hands are contaminated by blood. Section 6. and turn it ON again 1 . the error messages are listed in "Alphabetical" and "Functional" orders.2 minutes later. 1) Message List To search the pages. • Check QC data of control blood. • Referring to Chapter 4: INSTRUMENT MAINTENANCE AND SUPPLIES REPLACEMENT. 2.1: Clean SRV Search the following message lists for an error in question and refer to the corresponding pages in TROUBLESHOOTING: 7. • Timer mode turned OFF the pneumatic unit power. • Turn OFF the power and wipe off leaking fluid. always wear rubber gloves. 3. The screen displays nothing.October 1999 . When the power is ON. 7-15 Replenish Diluent----------------------------------------------------------------------------------. 7-9 [Q] QC Error--------------------------------------------------------------------------------------------. 7-8.7-31 [G] Abnormal GP (when graphic printer is incorporated)----------------------------------.7-24 Memory Error--------------------------------------------------------------------------------------.7-7.7-33 [I] Abnormal IP ---------------------------------------------------------------------------------7-30.7-28 [D] Abnormal DP (when data printer is incorporated)---------------------------------------------. 7-32 [H] HGB Error -----------------------------------------------------------------------------------------.7-20 Host Comm.7-29 Clean Waste Chamber.7-26 Clean SRV. 7-22 [B] Background Error ---------------------------------------------------------------------------------.7-31.7-11 Replenish Lyse ------------------------------------------------------------------------------------. 7-19 Set Value Error ------------------------------------------------------------------------------7-23. Error --------------------------------------------------------------------------------.7-16 [S] Sampling Error ------------------------------------------------------------------------------7-18. Low---------------------------------------------------------------------------------. 7-14 Room Temp.7-23 [P] Pressure/Vac Error ----------------------------------------------------------------------. ---------------------------------------------------------------------------.7-17 [C] Calibration Error-----------------------------------------------------------------------------------.7-25 [R] RBC Aperture Clog -------------------------------------------------------------------------------. 1 Alphabetical List of Error Messages Displayed on Analysis Screen [A] Analysis Error -------------------------------------------------------------------------------7-21.TROUBLESHOOTING 2 . High --------------------------------------------------------------------------------.7-13.7-15 Sysmex KX-21N Operator’s Manual -. 7-32 [M] Momentary Power Failure------------------------------------------------------------------------.7-12 Rinse Motor Error--------------------------------------------------------------------------. 7-24 [W] Waste Not Draining -------------------------------------------------------------------------------.7-10 WBC Aperture Clog ------------------------------------------------------------------------------. ----------------------------------------------------------------------------------------.October 1999 7-3 .7-16 Room Temp.7-27 Clean Transducer----------------------------------------------------------------------------------. (Turn OFF then ON the power. ----------------------------------------------------------------------. ---------------------------------------------------------------------------.7-18 Error has occurred during counting (RBC). --------------------------------------------------------------------.7-16 [S] Sampling Error has occurred.7-26 Clean the SRV.7-15 [D] DP printout error (when data printer is incorporated)-----------------------------------------.7-18 Error occurred during HGB analysis.7-29 Clean the Waste Chamber.7-32 [M] Memory error occurred.7-21 7-4 Sysmex KX-21N Operator’s Manual -.TROUBLESHOOTING 2 .5 kg/cm2 Pressure Error at count-----------------------------------------------------------------7-9 250 mmHg Vacuum Error---------------------------------------------------------------------------7-8 [A] Abnormal detection sensitivity-------------------------------------------------------------------.7-30 Error on Rinse Cup -------------------------------------------------------------------------7-13. ------------------------------------------------------------------------------------.-------------------------------------------------------------. --------------------------------------------------------------.5 kg/cm2 Pressure Error---------------------------------------------------------------------------7-7 0. ----------------------------------------------------------.---------------------------------------------------.7-32 GP printout error (when graphic printer is incorporated)-------------------------------------.7-19 [W] Waste Not Drained --------------------------------------------------------------------------------.7-11 Replenish Lyse Container. ---------------------------------------------------.7-22 [B] Background count exceeds tolerance.7-10 WBC/HGB Analysis Error-----------------------------------------------------------------------.7-31 [H] Host Output Error ---------------------------------------------------------------------------------.) ----------------------------7-23. -------------------------------------------------------------------.7-24 [Q] QC data falls out of control limits.7-12 Room Temp. ----------------------------------------------------------------------.October 1999 .7-27 Clean the Transducer.7-20 Error on IP -----------------------------------------------------------------------------------------. 7-24 Momentary power failure occurred.7-25 [R] Replenish Diluent Container. (Repairing) -----------------------------------------------------------.7-33 [I] IP paper empty-------------------------------------------------------------------------------------. Error -------------------------------------------------------------------------------.7-28 Clog in the aperture (RBC)-----------------------------------------------------------------------.7-15 Clog in the aperture (WBC)----------------------------------------------------------------------. 7-14 [G] GP paper empty (when graphic printer is incorporated)--------------------------------------.-----------------------------------------------------------.7-31 [E] Error has occurred during counting (PLT).7-23 Memory error occurred. ---------------------------------------------------. 2 Alphabetical List of Error Messages Displayed on HELP Screen 0.7-18 Error has occurred during counting (WBC).7-17 [C] Calibration value is out of range. ---------------------------------------------------------------. 7-16 Room Temp.7-23 Memory error occurred.) [Memory Error]-------. Low] -----------------------------------------------.7-24 Momentary power failure occurred. 8. [-]-------------------------------------------------.7-18 Error has occurred during counting. (Turn OFF then ON the power. 3.7-25 Calibration value is out of range.7-20 WBC/HGB Analysis Error [Analysis Error]-------------------------------------------. [Background Error] --------------------------. [Replenish Diluent]-------------------------------------.October 1999 7-5 .7-18 Error has occurred during counting.7-15 Temperature Errors Room Temp. [Calibration Error] ---------------------------------.7-23 Memory error occurred.5 kg/cm2 Pressure Error [Pressure/Vac Error] -----------------------------------------7-7 250 mmHg Vacuum Error [Pressure/Vac Error] -----------------------------------------7-8 0.7-21 Abnormal detection sensitivity [Analysis Error]---------------------------------------. (Turn OFF then ON the power.7-12 Motor Errors Error on Rinse Cup [Rinse Motor Error]-----------------------------------------7-13.7-22 Memory Errors Memory error occurred. (PLT) [Sampling Error] -----------------------.7-11 Replenish Lyse Container.5 kg/cm2 Pressure Error at count [Pressure/Vac Error] --------------------------------7-9 Chamber Errors Waste Not Drained [Waste Not Draining]----------------------------------------------. High]-----------------------------------------------. 6. Sysmex KX-21N Operator’s Manual -.7-10 Replenish Diluent Container.7-17 Error has occurred during counting. Pressure/Vacuum Errors 0. Error [Room Temp.7-24 Others QC data falls out of control limits.7-18 Sampling Error has occurred. 7-14 Aperture Errors Clog in the aperture (WBC) [WBC Aperture Clog]-----------------------------------. (RBC) [Sampling Error] ----------------------. [QC Error]-----------------------------------------. 5. 1.7-19 Error occurred during HGB analysis.7-26 2. (WBC) [Sampling Error]----------------------.7-16 Analysis Errors Background count exceeds tolerance. (Repairing) [Set Value Error]-------------------------------.) [Set Value Error] -----. [HGB Error] ----------------------------------.TROUBLESHOOTING 2 . 4. 3 Functional List of Error Messages NOTE: • [ ] indicates error naming that is displayed on the Analysis screen. [Replenish Lyse] ------------------------------------------. 7. [Sampling Error]---------------------------------------. Error [Room Temp.7-15 Clog in the aperture (RBC) [RBC Aperture Clog] ------------------------------------. TROUBLESHOOTING 9. Maintenance Errors Clean the SRV.7-32 GP paper empty [Abnormal GP]---------------------------------------------------------.7-28 Clean the Transducer.7-29 1 0 . [Clean Transducer.7-32 1 1 .7-27 Clean the Waste Chamber.] --------------------------------------------.7-30 GP printout error [Abnormal GP]--------------------------------------------------------.] ---------------------------------. [Clean Waste Chamber. Printer Errors Error on IP [Abnormal IP]----------------------------------------------------------------.7-31 IP paper empty [Abnormal IP] -----------------------------------------------------------. [Clean SRV.7-33 7-6 Sysmex KX-21N Operator’s Manual -. Error]------------------------------------------------.] -----------------------------------------------------------. External Option Errors Host Output Error [Host Comm.October 1999 .7-31 DP printout error [Abnormal DP] --------------------------------------------------------. Not Ready until the error is resolved.35 [0. Adjust pressure referring to Chapter 8.40 .40 . 1 Pressure/Vacuum Errors Error Message "Pressure/Vac Error" *Help* 0.5 kg/cm2 pressure adjustment error Pneumatic unit pressure error Air leakage from pressure line Adjust Pressure to 0.0. 2) Check Pressure Line Check the pressure line for loosened nipple or tube. press [1] key to return to the original screen.TROUBLESHOOTING 3.5 kg/cm2 is out of the monitor range in Ready status. If any abnormality is noted.60] Meaning of Message 0. reconnect or replace.October 1999 7-7 . or breakage. After adjustment or check.X.X 1:End of Adj Cause Action 1) 2) 3) 1) Analysis after error occurrence 0. The HELP screen displays pressure value in real time. TROUBLESHOOTING GUIDE 3 .60 kg/cm2 Adjust 0.5kg/cm2 Pressure.5 kg/cm2.5kg/cm2 Pressure Error 0.3: Adjusting Pressure to 0.5 kg/cm2. [1] Restarting to monitor the pressure ERR CODE:XXXXX.0. Monitor range: 0. Section 2. Sysmex KX-21N Operator’s Manual -. press [1] key to return to the original screen. After adjustment or check.X 1:End of Adj Cause Action 1) 2) 3) 4) 1) Analysis after error occurrence 250 mmHg vacuum adjustment error Fluid back-flows into the trap chamber. Pneumatic unit vacuum error Air leakage from vacuum line Adjust Vacuum to 250 mmHg The HELP screen displays vacuum value in real time. 2) Discard fluid in Trap Chamber Discard fluid if collected. Adjust vacuum referring to Chapter 8.4: Adjusting Vacuum to 250 mmHg. Section 3.X.October 1999 .TROUBLESHOOTING Error Message "Pressure/Vac Error" *Help* 250 mmHg Vacuum Error 215 [230 . reconnect or replace. Not Ready until the error is resolved. Section 2.270] Meaning of Message 250 mmHg vacuum is out of the monitor range in Ready status. Refer to Chapter 4. If any abnormality is noted. or breakage. [1] Restarting to monitor the vacuum ERR CODE:XXXXX. Monitor range: 230 .270 mmHg Adjust 250mmHg Vacuum. 3) Check Vacuum Line Check the vacuum line for loosened nipple or tube. 7-8 Sysmex KX-21N Operator’s Manual -.2: Check Trap Chamber Level and Discard. 5 kg/cm pressure is out of the monitor range during analysis.TROUBLESHOOTING Error Message "Pressure/Vac Error" *Help* 0. but the processing.3: Adjust 0.5 kg/cm2 pressure adjustment error Pneumatic unit pressure error Air leakage from pressure line Adjust Pressure to 0.5kg/cm2 Pressure Error at count Turn OFF then ON the power. The power needs to be turned OFF then ON again.X. Monitor range: 0.X 3:Ana.5 kg/cm2 Turn the power OFF. press [1] key to return to the original screen. After adjustment or check. Then adjust pressure referring to Chapter 8. of stored data in Select Menu can be performed.70 2 ERR CODE:XXXXX. Meaning of Message 0. and turned it ON again.30 .0. etc. Sysmex KX-21N Operator’s Manual -.October 1999 7-9 .5 kg/cm2 Pressure. reconnect or replace. The status is not ready for analysis. 0.Screen Cause Action 1) 2) 3) 1) Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. Section 2. 2) Check Pressure Line Check the pressure line for loosened nipple or tubing. If any abnormality is noted. or breakage. The status is not ready for analysis. 2 Chamber Errors Error Message "Waste Not Draining" *Help* Waste Not Drained Check kinked or blocked tubings. ERR CODE:XXXXX. clean or replace the tube. Specially check for contaminant or clogging near the drain outlet nipple. After adjustment or check. reconnect or replace. If any abnormality is noted. If any abnormality is present. Breakage or clogging of waste chamber or waste line tube Pneumatic unit pressure error Air leakage from pressure line Float switch malfunction Faulty operation of solenoid or master valve Check Waste Line Tube Check the waste drain line for breakage. or breakage. clogging.X. Not Ready until the error is resolved. [1] Retrying to drain the waste Meaning of Message Waste in the waste chamber can not be drained within the prescribed draining time. press [1] key to return to the original screen. but the processing.TROUBLESHOOTING 3 . 7-10 Sysmex KX-21N Operator’s Manual -.October 1999 . etc. of stored data in Select Menu can be performed. etc.X 1:Draining 3:Cancel Cause Action 1) 2) 3) 4) 5) 1) Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. 2) Check Pressure Line Check the pressure line for loosened nipple or tubing. TROUBLESHOOTING Error Message "Replenish Diluent" *Help* Replenish Diluent Container.X. but the processing. etc. of stored data in Select Menu can be performed. Sysmex KX-21N Operator’s Manual -. After replenishment or check.October 1999 7-11 . ERR CODE:XXXXX. 3) Check Vacuum Line Check the vacuum line for breakage and loosened nipple or tubing.X 1:Asp. If any abnormality is noted. 3:Cancel Cause Action 1) 2) 3) 4) 5) 1) Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. press [1] to return to the original screen. reconnect or replace. Not Ready until the error is resolved. replenish with a new diluent container. The status is not ready for analysis. Reag. Lack of diluent (CELLPACK) Diluent aspiration line error Air leakage from vacuum line Float switch malfunction Faulty operation of solenoid valve or master valve Replenish Diluent (CELLPACK) If there is no diluent. 2) Check Tube Check the diluent line tubing for breakage and the nipple for looseness. [1] Reaspirating Diluent Meaning of Message Diluent (CELLPACK) can not be aspirated within the prescribed diluent aspiration time. Reag. but the processing.X.TROUBLESHOOTING Error Message "Replenish Lyse" *Help* Replenish Lyse Container. ERR CODE:XXXXX. 3:Cancel Cause Action Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. press [1] key to return to the original screen. 7-12 Sysmex KX-21N Operator’s Manual -. Not Ready until the error is resolved. The status is not ready for analysis. [1] Reaspirating Lyse Meaning of Message No lyse remains. 1) Lack of lyse (STROMATOLYSER-WH) 2) Float switch malfunction 1) Replenish Lyse (STROMATOLYSER-WH) When no lyse is left. etc. replenish with a new lyse container.October 1999 . of stored data in Select Menu can be performed. After replenishment or check.X 1:Asp. Meaning of Message The rinse cup is at lower position at start-up (This happens only when the power is ON. then turn ON the power. 1) Rinse cup drive motor malfunction 2) The power was turned ON with the rinse cup remaining lowered.Screen Cause Action Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. The power needs to be turned OFF then ON again.) ERR CODE:XXXXX. of stored data in Select Menu can be performed. 3 Motor Errors Error Message "Rinse Motor Error" *Help* Error on Rinse Cup Turn OFF then ON the power. If Rinse Cup is out of position. etc. but the processing. Sysmex KX-21N Operator’s Manual -.X 3:Ana.October 1999 7-13 . The status is not ready for analysis.X. manually raise the rinse cup with both hands to the original top position. 1) Turn OFF the power. Turn power OFF and correct manually.TROUBLESHOOTING 3 . Screen Cause Action Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. 1) Rinse cup drive motor malfunction 2) Error of the rinse cup drive motor controller Faulty operation of CPU due to sudden noise interference. The power needs to be turned OFF then ON again.2: Clean Rinse Cup.October 1999 . Meaning of Message The rinse cup is not operating normally. etc.X 3:Ana. Section 7.TROUBLESHOOTING Error Message "Rinse Motor Error" *Help* Error on Rinse Cup Turn OFF then ON the power. etc.X. but the processing. of stored data in Select Menu can be performed. 7-14 Sysmex KX-21N Operator’s Manual -. 2) Turn OFF the power and clean the rinse cup. etc. The status is not ready for analysis. 1) Turn OFF the power and check to see that tubing. are not in contact with the top or bottom of rinse cup. ERR CODE:XXXXX. Refer to Chapter 4. Refer to Chapter 4. 4 Transducer Errors Error Message "WBC Aperture Clog" "RBC Aperture Clog" *Help* Clog in the aperture Parameter: WBC RBC 1 Execute clog removal sequence.then [Maintenance]->[Clean Transducer] or dab with brush after [SELECT]. Ready for analysis (although the next sample could be affected) Sysmex KX-21N Operator’s Manual -.2: Clean Transducer.TROUBLESHOOTING 3 . press[SELECT].X. 1) Transducer aperture clogging 1) Remove Aperture Clogging. the error may occur in the next analysis. Although the system is ready for analysis.3: Clean WBC/RBC Transducer Aperture. [Maintenance]->[Drain TD Chamber] ERR CODE:XXXXX.October 1999 7-15 . Section 7. 2) Transducer Rinse Sequence Pour 1 mL each of CELLCLEAN in the transducer chamber to perform auto rinse sequence.X 1:Clog Remove 3:Cancel Meaning of Message The monitor value for aperture clog is out of the prescribed range. Section 5. Cause Action Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. If clog persists. 3) Clean the Transducer with Brush Clean the aperture with brush. Press [1] key to execute automatic clog removal sequence. Refer to Chapter 4. TROUBLESHOOTING 3 . Low" *Help* Room Temp. High" "Room Temp.0°C Analysis data has lower reliability. ERR CODE:XXXXX.X.X 3:Return Cause Action Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. Although the system is ready for analysis. 5 Temperature Errors Error Message "Room Temp.40.5˚C [10.) 1) Check the Ambient Temperature Check to see that the ambient temperature is between 15°C 30°C. 1) Temperature in the transducer is high (or low.0 . Monitor range: 10.October 1999 .0 . Ready for analysis (although the next sample could be affected) 7-16 Sysmex KX-21N Operator’s Manual -.0] Meaning of Message Temperature in the unit (around the transducer) is out of the monitor range. Check the room temperature. the error may occur in the next analysis.Error 41.40. 3] (×103/µL) RBC 0.3×103/µL or less RBC 0. Dirty aperture Dirty HGB flow cell Bubbles mixing Faulty reagent Auto Rinse Press [1] key to perform Auto Rinse. background check reveals that the background count of any parameter exceeds the tolerance. the error may occur in the next analysis. WBC 0.05 [<=0.X 1:Auto Rinse 3:Cancel Meaning of Message In Auto Rinse. Although the system is ready for analysis. In case diluent is faulty.1 [<=0.3: Clean WBC/RBC Transducer Aperture. 6 Analysis Errors Error Message "Background Error" *Help* Background count exceeds tolerance. 2) Clean Transducer Refer to Chapter 4.0 [<=0.1g/dL or less PLT 10×103/µL or less Cause Action 1) 2) 3) 4) 1) Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. Section 7. Ready for analysis (although the next sample could be affected) Sysmex KX-21N Operator’s Manual -. Tolerance: WBC 0.October 1999 7-17 . Section 5.02×106/µL or less HGB 0. [1] Execute an Auto Rinse.TROUBLESHOOTING 3 . it will affect all parameters.2: Clean Transducer or Chapter 4.02](×106/µL) HGB 0. 3) Clean SRV Refer to Chapter 4.X. 4) Replenish Reagent Faulty lyse will affect background for WBC or HGB.1: Clean Sampling Valve (SRV). notably PLT background count. ERR CODE:XXXXX.1] (g/dL) PLT 12 [<=10] (×103/µL) Suspected a dirty aperture or SRV. Section 6. Transducer Rinse Sequence Pour 1 mL each of CELLCLEAN in the transducer chamber to perform auto rinse sequence.X 1:Clog Remove 3:Cancel Meaning of Message Sampling data falls into disorder.X. Cause Action Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. Sampling data refers to the count taken every 0. Refer to Chapter 4.2: Clean Transducer.5 seconds during counting. press[SELECT]. 2) Remove Source of External Noise Move the noise source away from the unit. 1) Dirty aperture 2) Effect of external noise interference 1) Clean Transducer 1. then [Maintenance]->[Clean Transducer] or dab with brush after [SELECT] [Maintenance]->[Drain T.3: Clean WBC/RBC Transducer Aperture. Although the system is ready for analysis. The system monitors the counts. [1] Execute clog removal sequence.October 1999 .Chamber] ERR CODE:XXXXX. If clog persists. 3. Section 7. the error may occur in the next analysis. Clean the Transducer with Brush Clean the aperture using brush. Ready for analysis (although the next sample could be affected) 7-18 Sysmex KX-21N Operator’s Manual -. Section 5. Parameter: WBC PLT Suspected a clogged aperture.D. 2. Remove Aperture Clogging Press [1] key to execute automatic clog removal sequence. Refer to Chapter 4.TROUBLESHOOTING Error Message "Sampling Error" *Help* Error has occurred during counting. X. ERR CODE:XXXXX.5 seconds during counting. Ready for analysis (although the next sample could be affected) Sysmex KX-21N Operator’s Manual -. The system monitors the counts taken.TROUBLESHOOTING Error Message "Sampling Error" *Help* Sampling Error has occurred. 1) Turn OFF then ON the power again. Meaning of Message Sampling data falls into disorder. 1) CPU malfunction due to sudden noise interference. If the error persists after turning ON the power again. Sampling data refers to the count taken every 0. the error may occur in the next analysis. etc. Although the system is ready for analysis. contact your Sysmex service representative.October 1999 7-19 .X 3:Retuen Cause Action Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. Blank value exceeds sample value.October 1999 . 2.) Meaning of Message HGB converted value is out of the prescribed range.2: Clean Transducer.X. Dirty HGB flow cell Bubbles mixed in HGB sample line Dirty WBC TD chamber Clean Transducer Press [1] key to execute the transducer rinse sequence. 7 minutes. Ready for analysis (although the next sample could be affected) 7-20 Sysmex KX-21N Operator’s Manual -. the error may occur in the next analysis. Refer to Chapter 4. (It will take approx. [1] Clean TD Chamber will be performed. Section 5.TROUBLESHOOTING Error Message "HGB Error" *Help* Error occurred during HGB analysis. ERR CODE:XXXXX. Although the system is ready for analysis. 1. Flow Cell may be dirty. Blank value is out of the range. Clean 3:Cancel Cause Action 1) 2) 3) 1) Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen.X 1:Exec. always execute "4: Replace Reagent" in the Select Menu. Section 8. making reference to Chapter 4. analyze the control blood and confirm that there is no abnormality.X 3:Return Cause Action Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen.October 1999 7-21 .1: Replenish Reagent. the error may occur in the next analysis. After replenishment and checking. Although the system is ready for analysis. ERR CODE:XXXXX. 1) Faulty lyse (STROMATOLYSER-WH) 1) Replenish Lyse After replenishing lyse.X. Ready for analysis (although the next sample could be affected) Sysmex KX-21N Operator’s Manual -.TROUBLESHOOTING Error Message "Analysis Error" *Help* WBC/HGB Analysis Error Meaning of Message WBC (including HGB) analysis error is continuing. and perform background check. Ready for analysis (although the next sample could be affected) 7-22 Sysmex KX-21N Operator’s Manual -.X.TROUBLESHOOTING Error Message "Analysis Error" *Help* Abnormal detection sensitivity Meaning of Message Sensitivity in the transducer exceeds the prescribed range. ERR CODE:XXXXX. Although the system is ready for analysis. In addition. 1) Faulty diluent (CELLPACK) 1) Replenish Diluent After replenishing diluent.October 1999 . the error may occur in the next analysis.X 3:Return Cause Action Analysis after error occurrence N O T E : • Press [3] key to return to the Analysis screen. execute "5: Auto Rinse" in the Select Menu. analyze the control blood to see that there is no abnormality. After completion of initializing. 1) Turn OFF then ON the power again. [2] 2 Deleting files and initializing.X Cause Action Analysis after error occurrence 1) Momentary power failure.October 1999 7-23 . perform all settings referring to Chapter 10: INSTRUMENT SETUP. and set values return to initial values.and QC data Meaning of Message Errors occur in the set values of the following: • Stored data • Quality Control data • Customer-set values [1] will be repaired.X. 7 Memory Errors Error Message "Memory Error" *Help* Memory error occurred. causes CPU malfunction. ERR CODE:XXXXX. sudden noise interference.X 1:Repairing 2:Initialize Cause Action Analysis after error occurrence 1) Momentary power failure. 1) Repair Press [1] key to execute repairing. Initializing deletes all stored data and QC data. 2) Initializing If execution of "1: Repairing" fails to correct the error. Turn OFF then ON the power. Not Ready until the error is resolved. etc. The alarm keeps sounding.) Error Message "Set Value Error" *Help* Memory error occurred. etc. Meaning of Message Error occurs on the Read Only Memory (ROM) or Random Access Memory (RAM). causes analysis value errors. Repairing may end incomplete. Inoperative (The power could be turned OFF. sudden noise interference. initialize using [2] key.X. ERR CODE:XXXXX. Sysmex KX-21N Operator’s Manual -. Stored data.TROUBLESHOOTING 3 . Meaning of Message Errors occur in the set values of the following: • Stored data • Quality Control data • Customer-set values • Factory-set values ERR CODE:XXXXX. 1) Turn OFF then ON the power again. Inoperative (The power could be turned OFF.TROUBLESHOOTING Error Message "Set Value Error" *Help* Memory error occurred. Turn OFF then ON the power. Ready for analysis (This error occurs at starting. Perform SHUTDOWN before turning OFF the power. Perform[SHUT DOWN]in prior to turning OFF the power. etc. 1:Continue Cause Action Analysis after error occurrence 1) Momentary power failure.X Cause Action Analysis after error occurrence 1) Momentary power failure or sudden noise interference causes set value errors. 2) Shutdown had not been performed the last time the unit was turned OFF. or [SHUT DOWN]has not been performed in the last time.) 7-24 Sysmex KX-21N Operator’s Manual -.October 1999 .) Error Message Momentary Power Failure Meaning of Message The program had not been normally quitted the last time the power was turned off. contact your Sysmex service representative for assistance. [1] Continue to start up. Momentary power failure occurred. Press [1] key to start up the unit. If the error persists even after the power is turned OFF then ON.X. caused the unit to stop temporarily. Analysis data is out of QC limits. a hardware problem may be suspected.X. 2) Analyze using New Vial. etc. Ready for analysis Sysmex KX-21N Operator’s Manual -. 3) Maintenance Service of Unit When the above 1) and 2) steps fail to resolve the error.TROUBLESHOOTING 3 . Refer to Chapter 4: INSTRUMENT MAINTENANCE AND SUPPLIES REPLACEMENT and clean the transducer. Meaning of Message This error occurs only when executing Quality Control.X 3:Return Cause Action 1) 2) 3) 4) 1) Analysis after error occurrence Control blood aspiration error Control blood insufficient mixing Faulty control blood Instrument failure Reanalyze Control Blood Press [3] key to return to the QC screen and perform reanalysis. SRV. ERR CODE:XXXXX.October 1999 7-25 . 8 Others Error Message "QC Error" *Help* QC data falls out of control limits. factor is out of 80%-120%. • 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. etc. Meaning of Message The set calibration value does not meet the conditions: • Difference from the last calibration must not exceed 5%.TROUBLESHOOTING Error Message "Calibration Error" *Help* Calibration value is out of range. 1) Checking Entered Values Press [3] key to return to the Calibration screen and check the target or calibration value. >=5% difference from the last calib. clean the transducer. Calib. If error persists. a hardware problem is conceivable. and if data is found to have shifted. • 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. Not Ready until calibration value is fixed.X. 7-26 Sysmex KX-21N Operator’s Manual -. SRV. 2) Maintenance of Instrument Check QC data. ERR CODE:XXXXX.X 3:Return Cause Action Analysis after error occurrence 1) Input error of target or calibration values 2) Instrument failure caused data to shift.October 1999 . • Calibration value must be in the range of 80% .120%. Referring to Chapter 4: INSTRUMENT MAINTENANCE AND SUPPLIES REPLACEMENT. it will be displayed at each startup until the cleaning is performed. after cleaning. If you perform cleaning later.Clean 3:Cancel Meaning of Message It is time to clean the SRV. execute "7: Maintenance. 9 Maintenance Errors Error Message *Scheduled Maint.1: Clean Sample Rotor Valve (SRV) ). and you can turn OFF the power. press [3] key. Three months have passed from the previous cleaning. [1] Reset the cycle counter for SRV. Cause Action Analysis after error occurrence N O T E : • When you clean SRV without pressing [1] key. Press [1] key. Following the instructions on the screen. turn OFF the power and clean the sample rotor valve (SRV). Cycle No. This activates the usual startup sequence and makes the system Ready. ∗ The same message will appear the next time you start the unit." and then "3: Reset Counter" in the Select Menu. 7567 Date last serviced 1/12/1999 1:Exec.October 1999 7-27 . Ready for analysis Sysmex KX-21N Operator’s Manual -. 7500 samples have been analyzed from the previous cleaning. [3] Continue to start up.* Clean the SRV. SRV cycle counter will not be reset.TROUBLESHOOTING 3 . (Refer to Chapter 4: Section 6. If you perform cleaning later. 2500 samples have been analyzed from the previous cleaning. Cycle No.TROUBLESHOOTING Error Message *Scheduled Maint* Clean the Waste Chamber. after cleaning. This activates the usual startup sequence and makes the system Ready. Ready for analysis 7-28 Sysmex KX-21N Operator’s Manual -. ∗ The same message will appear the next time you start the unit. Meaning of Message It is time to clean the waste chamber.1: Clean Waste Chamber ). clean the waste chamber. Section 5. One month has passed from the previous cleaning.Clean 3:Cancel Cause Action Analysis after error occurrence N O T E : • When the waste chamber rinse sequence has been completed. It will take approx. 2567 Date last serviced 1/12/1999 1:Exec. press [3] key. (Refer to Chapter 4.October 1999 . Press [1] key. 15 minutes. the cycle counter is automatically reset. Following the instructions on the screen. it will be displayed at each startup until the cleaning is performed. the cycle counter is automatically reset.2: Clean Transducer). Ready for analysis Sysmex KX-21N Operator’s Manual -.TROUBLESHOOTING Error Message *Scheduled Maint* Meaning of Message It is time to clean the transducer. after cleaning.Clean 3:Cancel Cause Action Analysis after error occurrence N O T E : • When the transducer rinse sequence has been completed. Following the instructions on the screen. If you perform cleaning later. 2500 samples have been analyzed from the previous cleaning. clean the transducer (Refer to Chapter 4.October 1999 7-29 . One month has passed from the previous cleaning. Cycle No. Section 5. Clean the Transducer. It will take approx. it will be displayed at each startup until the cleaning is performed. Press [1] key. 7 minutes. press [3] key. ∗ The same message will appear the next time you start the unit. This activates the usual startup sequence and makes the system Ready. 2567 Date last serviced 1/12/1999 1:Exec. [1] Restarting to print [3] Stop printing on IP To make IP on-line.X. then [Periph. When you want to try printing again. and make it to a normal status. paper-feed can be performed by pressing [2] key. Cause Action Analysis after error occurrence 1) The paper release lever is not in the secured position. refer to Chapter 10: INSTRUMENT SETUP and make settings for connecting the printer. For the built-in printer (IP). press[SELECT]. After checking.October 1999 . press [1] key to print the not completed data.X 1:Printing 2:Paper Feed 3:Stop Output Meaning of Message The printer has an error. 2) Make the Built-in Printer Off-line Press [3] key to make the printer off-line.Settings] ERR CODE:XXXXX. 1) Confirming the Printer Check the printer. 1 0 Printer Errors Error Message "Abnormal IP " *Help* Error on IP Press the paper guide lever down. 7-30 Sysmex KX-21N Operator’s Manual -. The main unit becomes Ready but cannot print. Not Ready until the error is resolved.TROUBLESHOOTING 3 . When you want to try printing again. The main unit becomes Ready but cannot print. refer to Chapter 10: INSTRUMENT SETUP and make settings for connecting the printer. ("GP" (graphic printer) or "DP" (data printer) is displayed in "##" of the screen. There is no power to the printer. Abnormality of connected cable Confirming the Printer Check the printer. press [1] key to print the not completed data 2) Make the Printer Off-line Press [3] key to make the printer off-line. Sysmex KX-21N Operator’s Manual -. Abnormal DP " *Help* ## printout error Check ## [1] Restart printing [3] Stop printing on ## To make ## on-line press[SELECT]. then [Periph.X 1:Printing 2:Paper Feed 3:Stop Output Meaning of Message The printer has an error.) Cause Action 1) 2) 3) 1) Analysis after error occurrence The printer is not connected. Not Ready until the error is resolved.TROUBLESHOOTING Error Message "Abnormal GP.X. After checking. and make it to a normal status.October 1999 7-31 .Settings] ERR CODE:XXXXX. 7-32 Sysmex KX-21N Operator’s Manual -. 1) No printer paper in the printer 1) Replace Print Paper Refer to Chapter 4. After replacing. then [Periph. Abnormal GP" *Help* ## paper empty [1] Restarting to print [3] Stop printing on ## To make ## on-line. ("IP" (built-in printer) or "GP" (graphic printer) is displayed in "##" of the screen.X.X 1:Printing 2:Paper Feed 3:Stop Output Meaning of Message Paper found empty .Settings] ERR CODE:XXXXX. The main unit becomes Ready but cannot print.TROUBLESHOOTING Error Message "Abnormal IP. press [1] key to print the data that has not yet printed. Section 8.) Cause Action Analysis after error occurrence N O T E : • For the built-in printer (IP). paper-feed can be performed by pressing [2] key. When you want to try printing. 2) Make the Printer Off-line When you press [3]. refer to Chapter 10: INSTRUMENT SETUP and make settings for connecting the printer.3: Replace Printer Paper. press[SELECT]. the printer is made off-line. Not Ready until the error is resolved.October 1999 . Settings] ERR CODE:XXXXX. data transmission is resumed. Sysmex KX-21N Operator’s Manual -.X.TROUBLESHOOTING 3 . Not Ready until the error is resolved.X 1:Re-sending 3:Stop Output Meaning of Message Communications cannot be made with the host computer. 1 1 External Device Errors Error Message "Host Comm. transmission to the host computer is canceled and the host is off-lined in the main unit. To resume transmission to 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 Action 1) 2) 3) 1) 2) Analysis after error occurrence Computer connecting cable failure Computer is not turned ON or not ready for communication. 3) Disconnecting Host Computer When you press [3] key. refer to Chapter 10: INSTRUMENT SETUP and make settings for connecting the host computer. Host computer serial interface error Inspect Host Computer Cable Inspect Connection Cable When you press [1] key after inspection. The main unit is now Ready but cannot output to the host computer. Error" *Help* Host Output Error *Host ACK Time Out Error* Check Host Condition [1] Retries to transmit to Host [3] Stop transmitting to Host To make Host Computer on-line. press[SELECT].October 1999 7-33 . then [Periph. October 1999 ." Press [ENTER] key. sensor status.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) (5) Using [ ] key or [ ] key. NOTE: • On the Menu screen. *Maintenance* 1:Clean W. Using [ ] key or [ ] key. each menu can be selected directly by entering a numeral from the numeric keys. The Status Display screen appears. cycle Nos. The Maintenance Menu screen appears. after performing the last maintenance. The Status Display screen displays in real time a currently-running sequence.TROUBLESHOOTING 4. move the cursor to select "5: Status Display. and currently-registered cycle No." Press [ENTER] key. Status Display Screen 1 P2. The Select Menu screen appears. and solenoid valve operating status. move the cursor to select "7: Maintenance. (1) (2) (3) Press [SELECT] key on the Analysis screen. The Status Display screen comprises two pages. Status Display Screen 2 Figure 7-4-2: Page Selection in Status Display Screen 7-34 Sysmex KX-21N Operator’s Manual -. STATUS DISPLAY The unit has the Status Display screen by which you can confirm the status of the instrument. you can turn over the pages using [ ] key or [ ] key. pressure/vacuum readings. Page Selection in Status Dislay Screen P1. You can also confirm on the screen HGB Converted value. Status Display Screen 2 Sysmex KX-21N Operator’s Manual -.TROUBLESHOOTING *Status* SEQ.52 240 550 Sequence No.No. Cycle No. PRESSURE VACUUM HGB CONVERT SENSOR SV WB Ready 12 0.October 1999 7-35 .5 kg/cm2 Pressure 250 mmHg Vacuum HGB Converted Value Sensor status Solenoid valve operating status 1 2 3 4 5 6 7 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 Change screen with [ ] or [ ] Figure 7-4-3: P1. after cleaning SRV Change screen with [ ] or [ ] Figure 7-4-4: P2. after cleaning transducer Cycle No. Status Display Screen 1 *Status* WB Ready 1234567 2567 2567 7567 COUNTER WASTE CHAMBER DETECTOR SRV Cycle No. 0. after cleaning waste chamber Cycle No. XXXXXX Date 24/12/2000 Time 09:15 Waste Not Draining XXXXXX. ERROR HISTORY PRINT Recent occurred ten times error history can be printed from the built-in printer. The Maintenance Menu screen appears.XXXXXX. move the cursor to select "6: Print Error History. Error XXXXXX." Press [ENTER] key.XXXXXX Date 24/12/2099 Time 12:30 Host Comm.October 1999 . move the cursor to select "7: Maintenance. .TROUBLESHOOTING 5. Date Time 31/12/2000 23:59 Print Example *Error History* Date 31/12/2000 Time 13:00 Pressure/Vac Error XXXXXX.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) (5) Using [ ] key or [ ] key. *Maintenance* 1:Clean W. Figure 7-5-2: Error History Print 7-36 Sysmex KX-21N Operator’s Manual -. . The Select Menu screen appears." Press [ENTER] key. Execution of Error History Print (1) Press [SELECT] key on the Analysis screen. The built-in printer prints the error history.XXXXXX. (2) (3) Using [ ] key or [ ] key.XXXXXX .XXXXXX. . " Press [ENTER] key.October 1999 7-37 .TROUBLESHOOTING 6. The Select Menu screen appears. *Maintenance* 1:Clean W. PROGRAM VERSION This menu can be used to display the program version." Press [ENTER] key. The Program Version screen appears. (1) (2) (3) Press [SELECT] key on the Analysis screen. The Maintenance Menu screen appears. move the cursor to select "7: Program Version. move the cursor to select "7: Maintenance. *Program Version* Program Version [1KXNF ##-##] Figure 7-6-2: Program Version Screen Sysmex KX-21N Operator’s Manual -. Using [ ] key or [ ] key.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) (5) Using [ ] key or [ ] key. ........................... 8-2 2........3 Adjusting Pressure to 0.....................................................5 kg/cm2 ...1 Location of Control Knobs........ 8-6 Sysmex KX-21N Operator’s Manual -........ 8-5 2...........................CHAPTER 8 ADJUSTMENT 1...........................October 1999 .................... 8-3 2. 2..4 Adjusting Vacuum to 250 mmHg .........................2 Pressure and Vacuum Display .............. 8-1 ADJUSTMENT OF PRESSURE AND VACUUM...... 8-2 2...................... INTRODUCTION...................... Should it require any adjustment subsequently. Your Sysmex service representative will perform initial adjustment. The following adjustment procedures are explained in this chapter.October 1999 8-1 .ADJUSTMENT 1.5 kg/cm2 • Vacuum: 250 mmHg Sysmex KX-21N Operator’s Manual -. INTRODUCTION The adjustment procedures described here are important in maintaining accuracy of this instrument. • Pressure: 0. follow the procedures given below. If the pressure or vacuum error message is displayed.5kg/cm2 Pressure [1] Restarting to monitor the pressure ERR CODE: XXXX.X.ADJUSTMENT 2. an error message is displayed. The pressure and vacuum are always monitored by pressure sensors. When an error occurs. 1 Location of Control Knobs 250 mmHg Bellows Unit 0.60] Adjust 0. If there is no such error. press [HELP] key to check pressure or vacuum value on the Help screen. (Refer to Chapter 7: TROUBLESHOOTING.0.40 . 2 .October 1999 . check tubing connections or the like for any air leakage.5 kg/cm2 and 250 mmHg.5 kg/cm2 Regulator Figure 8-2-1: Location of Control Knobs NOTE: • When an error has occurred.X 1:End of Adj Figure 8-2-2: Help Screen 8-2 Sysmex KX-21N Operator’s Manual -.5kg/cm2 Pressure Error 0.) *Help* 0. ADJUSTMENT OF PRESSURE AND VACUUM Pressure and vacuum from the built-in Pneumatic Unit are regulated to 0. display the Status Display screen and adjust pressure or vacuum as required.35 [0. Move the cursor using [ ] key or [ ] key. PRESSURE VACUUM HGB CONVERT SENSOR SV WB Ready 12 0. Sysmex KX-21N Operator’s Manual -.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) (5) Move the cursor using [ ] key or [ ] key.ADJUSTMENT 2 . The Maintenance Menu screen appears." Press [ENTER] key.No. and select "5: Status Display. The Status Display screen appears. 2 Pressure and Vacuum Display (1) (2) (3) Press [SELECT] key when the status is "Ready. and select "7: Maintenance." Press [ENTER] key.52 240 550 1 2 3 4 5 6 7 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 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. *Status* SEQ." The Select Menu screen appears.October 1999 8-3 . *Maintenance* 1:Clean W. 52 kg/cm 2 ) Vacuum: 250 mmHg (displaying 240 mmHg) 1 2 3 4 5 6 7 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 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.52 240 550 Pressure: 0.ADJUSTMENT NOTE: • The Status Display screen shows current pressure and vacuum. *Status* SEQ.October 1999 .5 kg/cm 2 (displaying 0. 8-4 Sysmex KX-21N Operator’s Manual -.No. PRESSURE VACUUM HGB CONVERT SENSOR SV WB Ready 12 0. Loosen the 0. 3 Adjusting Pressure to 0." display the Status Display screen. then raise it to the set level.October 1999 8-5 . Should any of them be too high.5± 0.1 kg/cm2 Low Loosen High Locking nut Adjusting knob Figure 8-2-6: Adjusting the Pressure CAUTION: • Always adjust pressure and vacuum so as to increase to the predetermined levels. While watching the pressure and vacuum indication on the Status Display screen. lower it to below that level once. (4) (5) When adjustment is finished.5 kg/cm2 regulator locking nut on the left side of the unit. Adjustment range: 0. Sysmex KX-21N Operator’s Manual -.2 Pressure and vacuum Display. Unless adjustment is properly conducted. turn the adjusting knob to regulate pressure and vacuum.ADJUSTMENT 2 . accurate adjustment may not be possible.5 kg/cm2 (1) (2) (3) Using the procedure of "2. tighten the locking nut while taking care not to allow the adjusting knob to rotate. Press [SELECT] key to return to the Ready status. Turn the adjusting knob clockwise to increase pressure and vacuum. lower it to below that level once. 8-6 Sysmex KX-21N Operator’s Manual -. Press [SELECT] key to return to the Ready status. loosen the locking nut for the bellows unit on the left side of the unit. While watching the pressure and vacuum indication on the Status Display screen. 4 Adjusting Vacuum to 250 mmHg (1) (2) (3) Using the procedure of "2. By turning counterclockwise. then raise it to the set level.ADJUSTMENT 2 . tighten the locking nut while taking care not to allow the adjusting knob to rotate." display the Status Display screen. accurate adjustment may not be possible. Adjustment range: 250± 10 mmHg Low High Loosen Adjusting knob Locking nut Figure 8-2-7: Adjusting the Vacuum CAUTION: • Always adjust pressure and vacuum so as to increase to the predetermined levels.2 Pressure and Vacuum Display. (4) (5) When adjustment is finished. Turn the adjusting knob clockwise to increase pressure and vacuum.October 1999 . turn the adjusting knob to regulate pressure and vacuum. Unless adjustment is properly conducted. Should any of them be too high. ..........................................4 Left Side Panel ....... 9-9 BLOOD CELL DISCRIMINATION CIRCUIT........ 8.. 9-28 NAMES AND FUNCTIONS OF INSTRUMENTS ......................................................... 8............1 Analysis of WBC Histogram ...................................................... 9-5 4..............2 Non-Cyanide Hemoglobin Analysis Method ........... Sysmex KX-21N Operator’s Manual -.CHAPTER 9 FUNCTIONAL DESCRIPTION 1.............................3 Calculation of RBC Constant...................... 9-1 DETECTION PRINCIPLE .........................October 1999 .1 WBC Discriminator......... 8.......................3 Right Side Panel.........................2 RBC Discriminator............................................. 4..................................................................................................................1 WBC/HGB Analysis Flow ......... 6................................ INTRODUCTION .. 8...............................................1 DC Detection Method.......... 5.......... 9-10 9-10 9-10 9-10 3....5 Left Side Interior ............ 9-30 9-30 9-31 9-32 9-33 9-34 9-35 7....................................................................................... 9-7 4...........1 Front Panel....... 9-2 MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM ................................... 5............... 9-2 2.... 8....................................... ANALYSIS OF HISTOGRAM ......................................... 8..3 PLT Discriminator .... 9-11 6............................ 9-5 4. 9-2 2................... 9-11 6...................... 5.................................................. 9-20 ELECTRIC SYSTEM .2 Analysis of RBC/PLT Histogram.. 2.........................2 Front Interior ............................................................................................................ 5.......................6 Rear Panel.................................. 9-4 CBC ANALYSIS ........... 8...........................2 RBC/PLT Analysis Flow ... FUNCTIONAL DESCRIPTION 1. INTRODUCTION This chapter describes blood cell count detection principle and analysis method used in this instrument.October 1999 9-1 . • Flow of Analysis: Flow of each analysis parameter on the main unit and analysis method for particle distribution are described. Also the hardware elements are explained. • Function of Measuring Unit: Names and functions of the measuring unit's elements are briefly described. Sysmex KX-21N Operator’s Manual -. and flow of individual analysis. • Detection Principle: Principle each of DC detection method and non-cyanide hemoglobin analysis method is described. diluted at the specified ratio. and a histogram of blood cell sizes is plotted by determining the pulse sizes. 2 . the blood cell size is detected as electric pulses. however. In addition. the Cyanmethemoglobin method or Oxyhemoglobin method have so far been the main stream. analyzing a histogram makes it possible to obtain various analysis data. causing direct current resistance to change between the electrodes. this method cannot be said suitable for a fully-automated instrument which is required to handle a large amount of waste. Cyanmethemoglobin method was recommended as the international standard method in 1966 by ICSH (International Committee for Standardization in Hematology). The transducer chamber has a minute hole called the aperture. 1 DC Detection Method Blood sample is aspirated.October 1999 . then fed into each transducer. As direct current resistance changes. this method uses the reagent of cyanide compound which is a poisonous substance and requires waste processing.FUNCTIONAL DESCRIPTION 2. there are the electrodes between which flows direct current. DC DC Supply Transducer Chamber External Electrode + Blood Cell Suspension Resistance Aperture Internal Electrode - Figure 9-2-1: DC Detection Method 2 . This method. On both side of the aperture. Blood cells suspended in the diluted sample pass through the aperture. 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. 9-2 Sysmex KX-21N Operator’s Manual -. it can hardly be called an environmentally favorable method. DETECTION PRINCIPLE This instrument performs blood cell count by DC detection method. Blood cell count is calculated by counting the pulses. At present. 2 Non-Cyanide Hemoglobin Analysis Method To analyze hemoglobin by automated methods. thus. measured to a predetermined volume. Also. FUNCTIONAL DESCRIPTION The Oxyhemoglobin method. etc. however. making the method suitable for automation. blood hemoglobin is converted instantaneously into oxyhemoglobin. in fact. on the other hand. making it suitable for automated method. Non-cyanide hemoglobin analysis method utilizes the advantages of both of the above methods. lower-than-real values result. is unable to convert methemoglobin into oxyhemoglobin. Consequently. Sysmex KX-21N Operator’s Manual -. although usual human blood poses no problems. it does not contain poisonous substance as cyanmethemoglobin method. is faster in hemoglobin conversion rate.October 1999 9-3 . this method can accurately analyze control blood. Being capable of analyzing methemoglobin. when a great amount of methemoglobin is contained as in control blood. which contain methemoglobin. Non-cyanide hemoglobin analysis method rapidly converts blood hemoglobin as the Oxyhemoglobin method and contains no poisonous substance. Also. This method. FUNCTIONAL DESCRIPTION 3.0 µL WBC/HGB Lyse Sample Rotor Valve (SRV) (1:500) 1. MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM <Whole Blood Mode> 1.October 1999 .0 mL 78 µL WBC TD Chamber (1:1000) HGB Flow Cell (1:1000) 1:26 Diluted Sample (200 µL) Figure 9-3-2: Hydraulic System in Pre-diluted Mode 9-4 Sysmex KX-21N Operator’s Manual -.960 mL Diluent 1.922 mL 1.996 mL Mixing Chamber 4.0 mL 6 µL WBC TD Chamber (1:500) RBC TD Chamber (1:25000) 40 µL HGB Flow Cell (1:500) Whole Blood Sample (50 µL) Figure 9-3-1: Hydraulic System in Whole Blood Mode <Pre-diluted Mode> 1.08 µL RBC TD Chamber (1:25000) WBC/HGB Lyse Sample Rotor Valve (SRV) 1.994 mL 1.99792 mL Diluent Mixing Chamber 2. At the same time. Of the diluted/hemolyzed sample in the WBC transducer chamber. (3) Sysmex KX-21N Operator’s Manual -.0 mL of WBC/HGB lyse is added to prepare 1:500 dilution sample. with WBC membrane held as they are. 1.FUNCTIONAL DESCRIPTION 4.994 mL Whole Blood 6 µL Pre-diluted Mode : Diluent 1.0 mL Sample Rotor Valve Whole Blood Mode 1 mL Pre-diluted Mode 1 mL HGB Flow Cell Whole Blood Mode : Diluent 1. approximately 1 mL is transferred to the HGB flow cell.0 mL Pre-diluted Mode 1.922 mL 1:26 Diluted Sample 78 µL WBC Transducer Tube or Microtube Whole Blood Mode: 50 µL Pre-diluted Mode: 1:26 Diluted Sample 200 µL Figure 9-4-1: WBC/HGB Analysis Flow • (1) (2) Whole Blood Mode Blood is aspirated from the sample probe into the sample rotor valve. RBC is hemolyzed and platelets shrink.0 mL WBC/HGB Lyse: Whole Blood Mode 1. 1 WBC/HGB Analysis Flow In WBC and HGB analysis.994 mL of diluent. The flow of WBC/HGB analysis is described below: Diluent: 2. At the same time. 6 µL of blood measured by the sample rotor valve is transferred to the WBC transducer chamber along with 1.October 1999 9-5 . CBC ANALYSIS 4 . the volume of WBC and hemoglobin in the blood are measured. hemoglobin is converted into red colored methemoglobin. When the solution is made to react in this status for approximately 10 seconds. hemoglobin is converted into red colored methemoglobin. This absorbance is compared with that of the diluent alone that was measured before addition of the sample. Concentration of this sample is measured as absorbance. When the solution is made to react in this status for approximately 10 seconds. At the same time. The pulses of the blood cells when passing through the aperture are counted by the DC detection method. Of the diluted/hemolyzed sample in the WBC transducer chamber. In the HGB flow cell. thereby calculating HGB (hemoglobin value). The pulses of the blood cells when passing through the aperture are counted by the DC detection method. Concentration of this sample is measured as absorbance. 500 µL of sample in the WBC transducer chamber is aspirated through the aperture. (5) • (1) (2) (3) (4) (5) 9-6 Sysmex KX-21N Operator’s Manual -. thereby calculating HGB (hemoglobin value).0 mL of WBC/HGB lyse is added to prepare 1:1000 dilution sample. This absorbance is compared with that of the diluent alone that was measured before addition of the sample.922 mL of diluent. RBC is hemolyzed and platelets shrink. 1. 555 nm wavelength beam irradiated from the light emitting diode (LED) is applied to the sample in the HGB flow cell. with WBC membrane held as they are. approximately 1 mL is transferred to 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. This sample is aspirated from the sample probe into the sample rotor valve. 78 µL of diluted blood measured by the sample rotor valve is transferred to the WBC transducer chamber along with 1.FUNCTIONAL DESCRIPTION (4) 500 µL of sample in the WBC transducer is aspirated through the aperture. In the HGB flow cell. Pre-diluted Mode Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK.October 1999 . At this time. FUNCTIONAL DESCRIPTION 4 . (1st step dilution) Out of the 1:500 dilution sample. HCT (hematocrit value) is calculated by RBC pulse height detection method.996 mL of diluent and brought to the mixing chamber as diluted sample. (4) Sysmex KX-21N Operator’s Manual -. The flow of RBC/PLT analysis is described below: • Whole Blood Mode Diluent: 2.960 mL of diluent. (2nd step dilution) 250 µL of the sample in the RBC/PLT transducer chamber is aspirated through the aperture. then transferred to the RBC/PLT transducer chamber.0 µL of blood measured by the sample rotor valve is diluted into 1:500 with 1. RBC and platelet count in the blood are measured.960 mL 1:500 Diluted Sample 40 µL RBC/PLT Transducer (1:500 Diluted Sample: 40 µL) Tube (Whole Blood: 50 µL) Mixing Chamber Figure 9-4-2: RBC/PLT Analysis Flow in Whole Blood Mode (1) (2) (3) Blood is aspirated from the sample probe into the sample rotor valve. RBC and PLT are counted by the DC detection method.0 mL Diluent 1. diluted into 1:25000 with 1. 2 RBC/PLT Analysis Flow In RBC/PLT analysis. 40 µL is measured by the sample rotor valve. At this time. At the same time. 4.996 mL Whole Blood 4 µL Sample Rotor Valve Diluent 1.October 1999 9-7 . 08 µL Sample Rotor Valve Microtube (1:26 Diluted Sample: 200 µL) RBC/PLT Transducer Figure 9-4-3: RBC/PLT Analysis Flow in Pre-diluted Mode (1) (2) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. At this time.October 1999 .0 mL Diluent 1.FUNCTIONAL DESCRIPTION • Pre-diluted Mode Diluent : 2.08 µL of diluted blood measured by the sample rotor valve is transferred in 1. Of the sample in the RBC/PLT transducer chamber. This sample is aspirated from the sample probe into the sample rotor valve. HCT (hematocrit value) is calculated by RBC pulse height detection method. 2. RBC and PLT are calculated by the DC detection method. and is made into 1:25000 dilution sample.99792 mL of diluent to the RBC/PLT transducer chamber. 250 µL is aspirated through the aperture. (3) 9-8 Sysmex KX-21N Operator’s Manual -.99792 mL 1:26 Diluted Sample 2. At the same time. HGB. 1. and HCT. Mean RBC Volume (MCV) Calculation is made from RBC and HCT by the formula below: MCV (fL) = HCT (%) RBC (×10 /µL) 6 ×10 2. Mean RBC Hemoglobin (MCH) Calculation is made from RBC and HGB by the formula below: MCH (pg) = HGB (g/dL) RBC (×10 /µL) 6 ×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 Sysmex KX-21N Operator’s Manual -.October 1999 9-9 . 3 Calculation of RBC Constant RBC constant (mean RBC volume.FUNCTIONAL DESCRIPTION 4 . mean RBC hemoglobin concentration) is calculated from RBC. mean RBC hemoglobin. 30 fL. are automatically determined by the microcomputer. 5 . 5 .250 fL.6 fL and 12 . respectively. BLOOD CELL DISCRIMINATION CIRCUIT WBC.FUNCTIONAL DESCRIPTION 5. 3 PLT Discriminator As to PLT LOWER discriminator and UPPER discriminator. 9-10 Sysmex KX-21N Operator’s Manual -. 5 . WBC is calculated from the particle counts more than this LOWER discriminator.60 fL is automatically determined by the microcomputer. 1 WBC Discriminator As to WBC LOWER discriminator. respectively. RBC. are automatically determined by the microcomputer. 2 RBC Discriminator As to RBC LOWER discriminator and UPPER discriminator. PLT count is calculated from the particle counts between this LOWER discriminator and UPPER discriminator. and PLT are discriminated and calculated by the following blood cell discriminator. the optimum position in 2 . the optimum position in 25 75 fL and 200 .October 1999 . the optimum position in 30 . RBC is calculated from the particle counts between this LOWER discriminator and UPPER discriminator. 250 fL PLT: Approx. which is considered highly correlated with lymphocyte count. 25 .FUNCTIONAL DESCRIPTION 6. WBC: Approx. 1 Analysis of WBC Histogram 1. and eosinophils. 30 . and PLT can be calculated respectively within the ranges given below.30 fL 6 . MXD# [W-MCC (WBC-Middle Cell Count) ] Mixed cells between discriminator (T1) and (T2). which is used as the monitor for histogram error. NEUT# [W-LCC (WBC-Large Cell Count)] Neutrophils more than discriminator (T2). basophils.October 1999 9-11 . RBC. The WBC histogram troughs in the (LD)-to-(UD) range are determined. ANALYSIS OF HISTOGRAM Analysis of histogram allows use of the flagging system that suggests sample error or instrument error. Histograms of WBC. which is considered highly correlated with neutrophils. • WBC Histogram WBC LD T1 T2 UD 100 Lymphocytes Mixed cells 200 Neutrophils 300 [fL] Figure 9-6-1: WBC Histogram 1) LYM# [W-SCC (WBC-Small Cell Count) ] Lymphocytes between discriminator (LD) and (T1). WBC Histogram The WBC histogram is discriminated into small. 2 . The UPPER discriminator (UD) is fixed at 300 fL. and large WBC by 3-part differential method using 4 discriminators. middle. The LOWER discriminator (LD) is automatically determined at an optimum position between 30 and 60 fL. 2) 3) Sysmex KX-21N Operator’s Manual -. the 1st one is defined TROUGH Discriminator 1 (T1) and the 2nd one TROUGH Discriminator 2 (T2).300 fL (particle after lyse dripping) RBC: Approx. which is considered highly correlated with the sum of monocytes. FUNCTIONAL DESCRIPTION 4) 5) 6) LYM% [W-SCR (WBC-Small Cell Ratio) ] Ratio of lymphocytes to whole WBC MXD% [W-MCR (WBC-Middle Cell Ratio) ] Ratio of mixed cells to whole WBC NEUT% [W-LCR (WBC-Large Cell Ratio) ] Ratio of neutrophils to whole WBC 9-12 Sysmex KX-21N Operator’s Manual -.October 1999 . F2: Middle cell histogram error.4 54. Applicable cases are those in which hemolysis is insufficient (for instance. which does not alter WBC count but may result in decreased platelet count. Probable cause is platelet agglutination. WL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable cause is inclusion of numerous platelet agglutinations. and etc. samples whose RBC membrane has extremely strong resistance against lyse) or in which numerous abnormal blood cells are present. Sysmex KX-21N Operator’s Manual -. T2: Higher TROUGH Discriminator. this flag is added to the PLT parameter.7 28. F3: Large cell histogram error. large platelets.3 17.October 1999 9-13 . that distinguishes lymphocytes and mixed cells. T1: Lower TROUGH Discriminator. WBC Histogram Error Flag When the WBC histogram is normal with three peaks. Relative frequency for T1 exceeds the range. If more than one flag are applied. Those histogram error flags are listed below in the order of higher priority. Therefore. there are a lower trough (T1) and a higher trough (T2) between LOWER discriminator (LD) and UPPER discriminator (UD). WU: Relative frequency for UPPER discriminator (UD) exceeds the range. Relative frequency for T1 or T2 exceeds the range. it is flagged as WBC histogram error. • Output Example of Normal WBC Three-Peak Histogram LD WBC T1 T2 UD 100 200 300 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# 6. AG: The particle count equal to or less than the LD exceeds a prescribed range. that distinguishes mixed cells and neutrophils.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.FUNCTIONAL DESCRIPTION 2.3 1. cannot be not determined.9 1. cannot be not determined.2 3. Relative frequency for T2 exceeds the range. F1: Small cell histogram error. the flag of the highest priority is taken. " "×. 1 2A 2B 3A 3B 3C 3D 4A 4B 4C 4D 5A 5B 6 7 LD High O O O O O O O O O O O O O T1 × × High High O O High High High High O O O T2 UD WBC LYM% MXD% NEUT% LYM# WL WL T1 WU WU WU F1 WU WU WU WU F1 F1 F1 T1 F1 F1 WL T1 T1 T2 T2 T2 T2 F2 F2 F2 F2 F2 F2 WL T1 T1 T2 T2 T2 T2 WL T1 T1 F1 F1 O High × × × × O O High High High High O O High O High O High O High O High High (The particle count equal to or less than LD is higher than the range) : : : : : : [1] [2] O High × Output flag to LCD screen. since CBC8 parameters only are output. A trough is not clear and cannot be detected. Any of "O . printer. Table 9-6-1: WBC Histogram Error Flags NOTE: • When analyzing in the pre-diluted mode. 2 Case No.October 1999 . 9-14 Sysmex KX-21N Operator’s Manual -. Output flag to host computer.FUNCTIONAL DESCRIPTION • WBC and Calculation Parameters versus Analysis Value Error Flags WBC Histogram Error Flag Output [1] [2] MXD# NEUT# HOST WL T1 T1 T2 T2 T2 T2 F1 F1 F3 F3 F3 F3 F1 F1 F2 F2 F2 F2 F2 F2 F3 F3 F3 F3 WL T1 T1 T2 T2 T2 T2 1 5 5 6 6 6 6 7 7 7 7 8 8 2 PLT parameter is flagged with AG." and "High" is applicable. Analysis result of each discriminator is normal Frequency for each discriminator is higher than the range. flagging is limited to a WBC parameter. NEUT#). NEUT#) and their data are not output. LYM% and LYM#. WL flag is added to mixed cell and neutrophil parameters (MXD%.FUNCTIONAL DESCRIPTION 1) 1A Histogram having high LD frequency with troughs T1 and T2 WL flag is added to all WBC parameters (WBC.. WBC Histogram Error-WL (1C) LD WBC UD • WBC LYM% MXD% NEUT% LYM# MXD# NEUT# WL +16.[%] 1. WBC Histogram Error-WL (1A) LD T1 WBC T2 UD • WBC LYM% MXD% NEUT% LYM# WL 8.[%] ---..1 [%] WL 3..4 . Note [+] on WBC numeric data in the example below. LYM%..[×103/µL] ---.[×103/µL] ---. [×103/µL] WL WL WL WL WL WL ---. MXD#...[×103/µL] 100 200 300 [fL] Figure 9-6-5: WBC Histogram Error-WL (1C) Sysmex KX-21N Operator’s Manual -. This WBC value exceeds the upper Patient Mark Limits mentioned earlier.3 [×103/µL] ---.. MXD#. LYM#.6 [×103/µL] 100 200 300 [fL] 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.[%] ---.[%] ---. MXD%.[×103/µL] 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.October 1999 9-15 .-]) WBC Histogram Error-WL (1B) LD T1 WBC UD • 100 200 300 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# WL WL WL WL WL WL WL 2.8 [×103/µL] 45.9 [%] ---.6 [%] WL 43.[×103/µL] ---. NEUT%.5 [×103/µL] WL 39..5 [×103/µL] WL 3..[%] ---. NEUT%. ([---.3 [%] WL 17.4 [×103/µL] WL 1.. [×103/µL] ---. Mixed cell and neutrophil parameters (MXD%.. Note that WBC in the graph exceeds the upper Patient Mark Limits.[%] ---. WBC Histogram Error-T2 (3A) LD T1 WBC UD 6) • 100 200 300 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# F1 T2 T2 F1 T2 T2 5. All other parameters are flagged with T1 and their data are not output. NEUT#) are flagged with T2 and their data are not output.5 [×103/µL] ---.[%] ---.FUNCTIONAL DESCRIPTION 4) 2A Histogram without T1 Although the histogram error flag is not added to WBC. MXD#. MXD#.. NEUT%.7 [%] ---....[%] ---. Mixed cell and neutrophil parameters (MXD%. WBC Histogram Error-T1 (2A) LD WBC UD • 100 200 300 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# T1 T1 T1 T1 T1 T1 +15. NEUT%.4 [×103/µL] ---. 3A Histogram with high T1 but without T2 WBC is not flagged. all other parameters are flagged with T1 and their data are not output.. LYM#) are flagged with F1.[×103/µL] ---..October 1999 . 9-16 Sysmex KX-21N Operator’s Manual -. NEUT#) are flagged with T2 and their data are not output..[×103/µL] ---.[%] ---.[×103/µL] Figure 9-6-7: WBC Histogram Error-T2 (3A) 7) 3B Histogram with high T1 but without T2.2 [×103/µL] 29. LYM#).[%] 1. and high in UD frequency WBC is flagged with WU and lymphocyte parameters (LYM%...[×103/µL] Figure 9-6-6: WBC Histogram Error-T1 (2A) 5) 2B Histogram having high UD but without T1 WBC is flagged with WU. F1 flag is added to lymphocyte parameters (LYM%. Mixed cell and neutrophil parameters (MXD%.3 [%] F1 1.6 [×103/µL] T2 ---.9 [×103/µL] F2 1. 1 0 ) 4A Histogram with high T1 WBC and neutrophil parameters (NEUT%.3 [%] F2 17.2 [×103/µL] 3. and with high UD WBC is flagged with WU.7 [×103/µL] F1 28. MXD#.[%] T2 ---.[×103/µL] Figure 9-6-8: WBC Histogram Error-T2 (3C) 9) 3D Histogram with high T1 but no T2.F1 (4A) LD T1 WBC T2 UD 100 200 300 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# 6. MXD#) with F2.6 [×103/µL] Figure 9-6-9: WBC Histogram Error . • WBC Histogram Error . NEUT%. MXD#) are flagged with F2. WBC Histogram Error-T2 (3C) LD T1 WBC UD • 100 200 300 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# +15. LYM#) are not flagged. MXD#. Sysmex KX-21N Operator’s Manual -. LYM#) are not flagged as the histogram error. NEUT#) are not flagged. LYM#) are flagged with F1 and mixed cell parameters (MXD%.[%] 1. NEUT#) are flagged with T2 and their data are not output.F1 (4A) 1 1 ) 4B Histogram with high T1 and UD WBC is flagged with WU. NEUT#) are not flagged.. lymphocyte parameters (LYM%. NEUT#) are flagged with T2 and data are not output.. Neutrophil parameters (NEUT%. Lymphocyte parameters (LYM%. and mixed cell parameters (MXD%.. WBC shown below exceeds the upper Patient Mark Limits.9 [%] T2 ---.4 [%] 54.[×103/µL] T2 ---. NEUT%.2 [×103/µL] 12. LYM#) are flagged with F1. Mixed cell and neutrophil parameters (MXD%. Lymphocyte parameters (LYM%.October 1999 9-17 ..FUNCTIONAL DESCRIPTION 8) 3C Histogram with T1 but without T2 WBC and lymphocyte parameters (LYM%. and neutrophil parameters (NEUT%.F2 (5A) 1 5 ) 5B Histogram with high T2 and high UD WBC is flagged with WU and lymphocyte parameters (LYM%.7 [×103/µL] Figure 9-6-11: WBC Histogram Error . lymphocyte parameters (LYM%.F2 (5A) LD T1 WBC T2 UD 100 200 300 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# F2 F3 F2 F3 +18.8 [%] 1. LYM#).1 [×103/µL] 2. mixed cell parameters (MXD%. 1 4 ) 5A Histogram with high T2 Histogram error flag is not added to WBC and lymphocyte parameters (LYM%. • WBC Histogram Error . NEUT#) with F3. Mixed cell parameters (MXD%.October 1999 .7 [×103/µL] 20. MXD#) with F2. and UD WBC data are output with WU flag. mixed cell parameters (MXD%. WBC and MXD% exceed the upper Patient Mark Limits.3 [×103/µL] Figure 9-6-10: WBC Histogram Error . • WBC Histogram Error . LYM#) are not flagged.FUNCTIONAL DESCRIPTION 1 2 ) 4C Histogram with high T1 and high T2 WBC is not flagged. and neutrophil parameters (NEUT%. LYM#) are flagged with F1. NEUT#) with F3 flag. MXD#) are flagged with F2. MXD#) with F2 flag.7 [%] 66. Mixed cell parameters (MXD%. and neutrophil parameters (NEUT%. NEUT#) with F3.2 [%] 68. MXD#) are flagged with F2. Lymphocyte parameters (LYM%. and neutrophil parameters (NEUT%.8 [%] 11.F1 (4C) LD T1 WBC T2 UD 100 200 300 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# F1 F2 F3 F1 F2 F3 10. NEUT#) with F3 flag. LYM#) with F1 flag.2 [×103/µL] 1. 9-18 Sysmex KX-21N Operator’s Manual -.2 [×103/µL] 7.0 [%] 2.5 [%] +23.7 [×103/µL] 7. T2.F1 (4C) 1 3 ) 4D Histogram high in all T1.5 [×103/µL] 9. 1 [×103/µL] Figure 9-6-12: WBC Histogram Error .4 [×103/µL] 24.3 [×103/µL] 1.FUNCTIONAL DESCRIPTION 1 6 ) 6 Histogram with high UD WBC is flagged with WU and other parameters are not flagged.5 [%] 7.5 [%] 68 [%] 3. Sysmex KX-21N Operator’s Manual -.October 1999 9-19 .0 [×103/µL] 8.WU (6) 1 7 ) 7 The particle count equal to or less than LD is higher than the range.WU (6) LD T1 T2 WBC UD 100 200 300 [fL] WBC LYM% MXD% NEUT% LYM# MXD# NEUT# WU+ 15. WBC in this instance exceeds the upper Patient Mark Limits. • WBC Histogram Error . PLT is flagged with AG and other parameters are not flagged. 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.250 fL. check is made for relative frequency errors on respective discriminator levels. • Definition of RDW-SD 100% 20% RDW-SD Figure 9-6-14: Definition of RDW-SD 9-20 Sysmex KX-21N Operator’s Manual -.26% of the entire particle area: • Calculation of RDW-CV RDW-CV (%) = L2 . RBC Histogram As mentioned earlier.FUNCTIONAL DESCRIPTION 6 .75 fL and 200 . after determining points L1 and L2 for 68. 2 Analysis of RBC/PLT Histogram 1.26% of Entire Distribution Area L1 L2 Figure 9-6-13: Calculation of RDW-CV RDW-SD (RBC Distribution Width . for more than one peak. respectively.Standard Deviation) is set on 20% frequency level with the peak taken as 100%. As to histogram.L1 L2 + L1 ×100 68.October 1999 . RBC are determined as particle counts between two discriminators (LD) and (UD) which are automatically counted in the ranges of 25 . Sysmex KX-21N Operator’s Manual -. 3) P-LCR (Large Platelet Ratio) This is the ratio of large platelets exceeding 12 fL discriminator and is calculated as the ratio of the particle count between the 12-fL fixed discriminator and Upper discriminator (UD) to the particle count between Lower discriminator (LD) and Upper discriminator (UD). The analysis method used is the same as mentioned in HCT analysis principle 4. respectively -and the fixed discriminator at 12 fL.30 fL. PLT Histogram Platelet histogram is analyzed using three discriminators: two discriminators (LD) and (UD) . Regarding PLT histogram.6 fL and between 12 . and there is a single peak.2 RBC/PLT Analysis Flow in this chapter. distribution width error. 1) PDW (PLT Distribution Width) PDW is the distribution width on 20% frequency level with the peak taken as 100%. Definitions of PDW and P-LCR • 100% P-LCR 20% (LD) (12fL) PDW (UD) Figure 9-6-15: Definitions of PDW and P-LCR 2) MPV (Mean Platelet Volume) MPV is calculated by the following formula: MPV (fL) = PCT (%) PLT (×10 /µL) 3 ×1000 Where PCT (%) represents the value weighted with PLT frequency and is called platelet-crit or platelet volume ratio. check is made to see that there are no relative frequency errors at discriminators (LD) and (UD).October 1999 9-21 .determined automatically between 2 . The unit applied is fL (femto = 10-15L).FUNCTIONAL DESCRIPTION 2. when RBC histogram has a single peak High: Frequencies of LD and UD are higher than the range ×: • In the case of DW.October 1999 . when RBC histogram has two or more peaks : Any of "O . RBC morphological change. a flag is not output to RDW-SD or RDW-CV. printer. Probable cause is the effect of noise. Probable cause is the effect of noise. When the 20% frequency does not cross the histogram two times. when RDW-SD could not be analyzed • In the case of MP. • Matching of eight kinds of RBC histogram error flags RBC Histogram Error Flag Output [1] Case No. 1A 1B 1C 2A 2B 2C 3 4 [1]: [2]: O: LD High High High O O O O O UD DW O × MP O O × O O × O × RBC RL RL RL RU RU RU HCT RL RL RL RU RU RU MCV RL RL RL RU RU RU MCH MCHC RL RL RL RU RU RU RL RL RL RU RU RU PLT RL RL RL RU RU RU RDW -SD RL DW MP RU DW MP DW MP [2] RDW -CV HOST RL 1 RL MP RU RU MP MP 1 1 2 2 2 3 4 High High High O O O × × Output flag to LCD screen. this flag is attached. Output flag to host computer. RL: Relative frequency for LOWER discriminator (LD) exceeds the range. • When analysis results of LD and UD are normal • In the case of DW. platelet coagulation. when RDW-SD could be analyzed • In the case of MP. 9-22 Sysmex KX-21N Operator’s Manual -. When two or more flags are applicable to a parameter. the highest-priority flag is used." and "High" is applicable. or the like. a histogram error flag is added to the corresponding parameter of the analysis value. Table 9-6-2: RBC Histogram Error Flags NOTE: • Since CBC8 parameters only are output in the pre-diluted mode. MP: Two or more peaks in histogram. Those histogram error flags are listed in the order of higher priority. RU: Relative frequency for UPPER discriminator (UD) exceeds the range. RBC Histogram Error Flag When RBC histogram is not normal.FUNCTIONAL DESCRIPTION 3. DW: Particle distribution width error for 20% frequency with the peak taken as 100%." "×. MCHC. and PLT parameters are flagged with RL. and particle distribution width data parameters are flagged with RL. and PLT parameters are flagged with RL. HCT.1 [fL] 32. RDW-CV is flagged with MP and its data are output. while RDW-SD is flagged with MP but its data are not output. MCV.57 [×106/µL] 11. PLT. MCH.RU (2A) RBC 3) 4) • 100 200 250 [fL] RBC HGB HCT MCV MCH MCHC RDW-SD PLT RU RU RU RU RU RU RU 3.5 [g/dL] 41. RDW-CV is flagged with RL and its data are output. MCHC. MCH.RU (2A) Sysmex KX-21N Operator’s Manual -.2 [pg] -27. MCH.7 [fL] 185 [×103/µL] Figure 9-6-17: RBC Histogram Error . MCH. MCHC. RBC Histogram Error . 1C High LD with two or more peaks RBC.5 [g/dL] +91. HCT. MCV.1 [fL] 32.8 [%] +117. MCHC. 2A Frequency high for UD RBC. and RDW-SD. MCV and RDW-SD exceed the upper Patient Mark Limits. RDW-SD parameter is flagged with DW and its data are not output.7 [fL] 185 [×103/µL] Figure 9-6-16: RBC Histogram Error .RL (1A) RBC • 100 200 250 [fL] RBC HGB HCT MCV MCH MCHC RDW-SD PLT RL RL RL RL RL RL RL 3.57 [×106/µL] 11. and MCHC falls below the lower Patient Mark Limits. HCT. MCV. RBC Histogram Error . In this instance. MCV. MCHC. Of the particle distribution width data.8 [%] +117.5 [g/dL] +91. flags to indicate that their data are out of Patient Mark Limits are added to MCV.5 [g/dL] 41.2 [pg] -27. and particle distribution width data parameters are flagged with RU.RL (1A) 2) 1B High frequency for LD with 20% particle distribution width error RBC. PLT.October 1999 9-23 . HCT.FUNCTIONAL DESCRIPTION 1) 1A Histogram with high frequency for LD RBC. RDW-CV data are output with MP flag. MCH.2 [g/dL] 41. MCH.5 [fL] 29. HCT.MP (4) 9-24 Sysmex KX-21N Operator’s Manual -. and PLT parameters are flagged. DW (2B) 6) 2C High UD with two or more peaks RBC.5 [g/dL] 52.RU. In this instance. and PLT parameters are not flagged. RBC Histogram Error .57 [×106/µL] 11. RDWCV is out of Patient Mark Limits. while RDW-SD data are flagged with DW and their data are not output.October 1999 .2 [g/dL] +33. HCT. Out of the particle distribution width data. MCV. while RDW-SD is also flagged with MP but its data are not output. As to particle distribution width data. RDW-CV is flagged with MP and its data are output. RBC Histogram Error .5 [%] 86.80 [×106/µL] 14.FUNCTIONAL DESCRIPTION 5) 2B High UD with 20%-frequency distribution width error RBC. As to the particle distribution width data. MCV. MCV and MCHC are out of Patient Mark Limits. In this instance. MCHC.9 [%] +148.RU.[fL] 185 [×103/µL] Figure 9-6-18: RBC Histogram Error . 4 Two or more peaks RBC.2 [pg] -21. As to the particle distribution width data. MCH. MCHC.3 [%] 216 [×103/µL] Figure 9-6-19: RBC Histogram Error . MCHC. RDW-CV data are output without flagging. DW (2B) RBC • 100 200 250 [fL] RBC HGB HCT MCV MCH MCHC RDW-SD PLT RU RU RU RU RU DW RU 3.CV PLT MP 4. RDW-CV is flagged with RU and its data are output.. and PLT parameters are flagged with RU. MCHC. MCV. MCH. 3 20%-frequency particle distribution width error RBC. RDW-SD is flagged with DW and its data are not output. MCV. HCT.2 [fL] 32.7 [g/dL] ---. HCT. RDW-SD is flagged with MP and its data are not output.6 [pg] -34.MP (4) RBC 7) 8) • 100 200 250 [fL] RBC HGB HCT MCV MCH MCHC RDW. and PLT parameters are not flagged. PL: Relative frequency for LOWER discriminator (LD) exceeds the range.October 1999 9-25 . Probable cause is the effect of noise and etc.used with the particle distribution analysis unit mounted. when PLT histogram has a single peak High: Frequencies of LD and UD are higher than the range. when PLT histogram has two or more peaks : Any of "O ." and "High" is applicable. • Matching of eight kinds of platelet histogram error flags Platelet Histogram Error Flag Output [1] Case No. printer. the highest priority flag is used. O: • When analysis results of LD and UD are normal • In the case of DW. a histogram error flag is added to the corresponding parameter of the analysis value. and etc. when PDW could be analyzed • In the case of MP.FUNCTIONAL DESCRIPTION 4. Those histogram error flags . When the 20% frequency does not cross the histogram two times. When two or more flags are applicable to a parameter. 1A 1B 1C 2A 2B 2C 3 4 LD High High High O O O O O High High High O O × O × UD DW O × MP O O × O O × O × PLT PL PL PL PU PU PU PDW PL DW MP PU DW MP DW MP [2] MPV P-LCR HOST PL PL PL PU PU PU DW MP PL PL PL PU PU PU DW MP 1 1 1 2 2 2 3 4 [1]: Output flag to LCD screen. MP: Two or more peaks in histogram DW: Particle distribution width error for 20% frequency with the peak taken as 100%. [2]: Output flag to host computer. this flag is attached. when PDW could not be analyzed • In the case of MP. PU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable cause is the effect of platelet agglutination. noise interference. ×: • In the case of DW. Table 9-6-3: Platelet Histogram Error Flags Sysmex KX-21N Operator’s Manual -. are listed in the order of higher priority. Platelet Histogram Error Flag When the platelet histogram is not normal." "×. 2B High UD with 20%-frequency particle distribution width error PLT parameter is flagged with PU. MPV and P-LCR are flagged with PU and their data are not output. and P-LCR parameters are flagged with PU. Particle distribution width (PDW) is flagged with DW and its data are not output. 2A High UD PLT. MPV. MPV. flag output is limited to a PLT parameter.6 [%] Figure 9-6-20: Platelet Histogram Error . Platelet Histogram Error .[%] Figure 9-6-21: Platelet Histogram Error .FUNCTIONAL DESCRIPTION NOTE: • Since CBC8 parameters only are output in the pre-diluted mode...PU (2B) PLT 3) 4) 5) • PLT PDW MPV P-LCR 10 20 30 [fL] PU DW PU PU 171 [×103/µL] ---.PL (1A) PLT • PLT PDW MPV P-LCR 10 20 30 [fL] PL PL PL PL 211 [×103/µL] 12.3 [fL] -22. Particle distribution width (PDW) is flagged with MP and its data are not output. 1) 1A High frequency for LD PLT.October 1999 .5 [fL] 9.[fL] ---. MPV and P-LCR are flagged with PL and their data are not output. 1C High LD with two or more peaks PLT parameter is flagged with PL.. Platelet Histogram Error .[fL] ---. Particle distribution width (PDW) is flagged with DW and its data are not output. PDW.PL (1A) 2) 1B High LD with 20%-frequency distribution width error PLT parameter is flagged with PL. PDW.PU (2B) 9-26 Sysmex KX-21N Operator’s Manual -. and P-LCR parameters are flagged with PL. MPV and P-LCR are flagged with PL and their data are not output. October 1999 9-27 .. MPV and P-LCR are flagged with PU and their data are not output.[%] Figure 9-6-23: Platelet Histogram Error . and P-LCR are flagged with DW and their data are not output.DW (3) PLT 7) • PLT PDW MPV P-LCR 10 20 30 [fL] 91 [×103/µL] DW ---. Platelet Histogram Error . 3 20%-frequency particle distribution width error PLT is not flagged.FUNCTIONAL DESCRIPTION 6) 2C High UD with two or more peaks PLT parameter is flagged with PU.MP (4) Sysmex KX-21N Operator’s Manual -. PDW.[fL] DW ---. MPV. Platelet Histogram Error .MP (4) PLT • PLT PDW MPV P-LCR 10 20 30 [fL] 155 [×103/µL] MP ---.[fL] MP ---.[%] Figure 9-6-22: Platelet Histogram Error ..[fL] DW ---.. Other parameters are flagged with MP and their data are not output.DW (3) 8) 4 Two or more peaks PLT is not flagged. Particle distribution width (PDW) is flagged with MP and its data are not output...[fL] MP ---.. October 1999 . and then sent to the HGB counting circuit for the calculation of the absorbance. and outputs them to the printer or to the host computer. and waste in the hydraulic system. The microcomputer converts the analogue signals into digital signals for the calculation. The beam that has passed through the fluid is detected by the photo diode.FUNCTIONAL DESCRIPTION 7. Electric signals received from various transducers go through the analogue circuit for electrical waveform-processing. And the signals is photoelectrically converted. and to the microcomputer. reagents. thus regulating the flow of samples. absorbance of only the diluent (background) is deducted from samples' absorbance. where the noise in signals is eliminated to acquire the required cell signals only. RBC. The WBC. The microcomputer converts the A/D-converted cell signals into particle distribution data. A/D converted. ELECTRIC SYSTEM The microprocessor in the main unit controls the hydraulic system's solenoid valves and master valves. and PLT cell signals are sent to the respective waveform-processing circuits in the analogue circuit. 9-28 Sysmex KX-21N Operator’s Manual -. To calculate HGB. PLT Detection Circuit WBC Calculator Bus RBC Amplification Waveform Processing Circuit Interface RBC A-D Conversion Circuit PLT A-D Conversion Circuit Interface Sysmex KX-21N Operator’s Manual -.October 1999 WBC A-D Conversion Circuit Interface Data Printer (Option) Serial Interface (Computer) LCD Interface Display Unit LCD screen HGB Conversion Circuit PDA Unit Pressure Monitoring Unit Driver Solenoid Motor Interface InputOutput Interface Operation Unit Panel Switch Built-in Printer Printer Interface Built-in Printer Figure 9-7-1: Electric Diagram HGB Transducer HGB Amplification Circuit FUNCTIONAL DESCRIPTION 9-29 .Microcomputer Circuit WBC Counting Circuit Interface Main Unit Transducer RBC Counting Circuit PLT Counting Circuit Processor HGB Counting Circuit Interface Memory Electric Diagram Analogue Circuit WBC Transducer WBC Detection Circuit WBC Amplification Waveform Processing Circuit Handy Barcode Reader (Option) Interface Graphic Printer (Option) RBC. PLT Transducer PLT Amplification Waveform Processing Circuit RBC Calculator RBC. 1 Front Panel 4) Graphic Screen Sysmex 1) Front Cover 2) Sample Probe 3) START switch 5) Panel Keyboard Figure 9-8-1: Front Panel 1) Front Cover The front cover can be opened to the right by your hands. 2) 3) 4) 5) 9-30 Sysmex KX-21N Operator’s Manual -. check or clean the interior of measuring unit. START Switch This switch starts whole blood mode analysis and pre-diluted mode analysis. refer to Chapter 1. analysis results. refer to Chapter 1. instrument status. For detail. It is opened to replace lyse containers. Panel Keyboard This keyboard allows basic operations such as entry of Sample No. For detail. error messages. Section 8: GRAPHIC SCREEN. Graphic Screen This displays Sample Nos.October 1999 . Section 7: PANEL KEYBOARD.FUNCTIONAL DESCRIPTION 8.. Sample Probe The sample probe is used to aspirate sample in the whole blood and pre-diluted modes. NAMES AND FUNCTIONS OF INSTRUMENTS 8 . etc. and selection of analysis parameters. FUNCTIONAL DESCRIPTION 8 . Sysmex KX-21N Operator’s Manual -. 2 Front Interior 1) Detector Block 2) Sample Rotor Valve (SRV) 3) Rinse Cup 4) WBC/HGB Lyse (STROMATOLYSER-WH) 5) Built-in Printer Figure 9-8-2: Front Interior 1) 2) 3) 4) 5) Detector Block Incorporates RBC transducer. and HGB flow cell. etc. error messages. Sample Rotor Valve (SRV) Makes volumetric measurement of aspirated blood.October 1999 9-31 . WBC transducer. WBC/HGB Lyse (STROMATOLYSER-WH) Reagent to measure WBC/HGB Built-in Printer Prints analysis data. Rinse Cup Cleans the sample probe. 15A-N1 Fuse 250 V 2 A No.15 A ST4-3. This will overload the fuse and may cause fuse blown. CAUTION • For continued protection against risk of fire. 3) Power Supply Connector Using the furnished power supply cord. 19195 Fuse Type Time Lag Time Lag WARNING • To avoid risk of electrical shock. 266-5109-1 266-5292-6 Description Fuse 250 V 3. use the fuse of specified type and rating.October 1999 . 2) Power Supply Switch Turns on and off the main unit power supply. this connector supplies power from the outlet. 3 Right Side Panel 1) Fuse 2) Power Supply Switch 3) Power Supply Connector Figure 9-8-3: Right Side Panel 1) Fuse Replace with provided time-lag type fuse. CAUTION: • Avoid turning this switch ON and OFF continuously in short duration. The rating will be different depending on the instrument specification. Specification 117 VAC 220/240 VAC Part No. 9-32 Sysmex KX-21N Operator’s Manual -. disconnect the power cord before replacing the fuses.FUNCTIONAL DESCRIPTION 8 . 4 Left Side Panel 3) 250 mmHg Bellows Unit 4) Air filter 1) Trap Chamber 2) 0.FUNCTIONAL DESCRIPTION 8 . 2) 3) 4) Sysmex KX-21N Operator’s Manual -. Air Filter Prevents dirt and dust from entering the bellows. 250 mmHg Bellows Unit Regulates vacuum to 250 mmHg vacuum.5 kg/cm2 Regulator Regulates pressure to 0.October 1999 9-33 . etc. 0. from flowing into the vacuum pump of the compressor when an error occurs with the instrument.5 kg/cm2.5 kg/cm2 Regulator Figure 9-8-4: Left Side Panel 1) Trap Chamber Prevents reagent. CAUTION: • Do no open the left face unless your Sysmex service representative asks you to.October 1999 . 5 Left Side Interior 1) Waste Chamber 2) Pneumatic Unit Figure 9-8-5: Left Side Interior 1) 2) Waste Chamber Collects wastes from transducers and mixing chambers.FUNCTIONAL DESCRIPTION 8 . Pneumatic Unit Supplies pressure and vacuum. 9-34 Sysmex KX-21N Operator’s Manual -. 6 Rear Panel 1) ID Reader Connector 2) GP Connector 5) Drain Outlet Nipple 3) DP Connector 4) Serial Interface 6) Diluent Inlet Nipple (CELLPACK) 7) Card Slot Protective Cover Figure 9-8-6: Rear Panel 1) 2) 3) 4) 5) 6) 7) ID Reader Connector Connects an optional handy barcode reader. It connects with the diluent container. Card Slot Protective Cover This is a protective cover for the slot to insert the program card. DP Connector Connects an optional data printer.October 1999 9-35 . GP Connector Connects an optional graphic printer. Diluent Inlet Nipple (CELLPACK) This nipple aspirates diluent. Serial Interface Connector for communicating with the host computer Drain Outlet Nipple This nipple drains waste.FUNCTIONAL DESCRIPTION 8 . It connects with the drain sewer or waste tank. Sysmex KX-21N Operator’s Manual -. ..................CHAPTER 10 INSTRUMENT SETUP 1................ 5... 2... 10-11 QC SETTINGS . 10-32 PRINT SET VALUES ....... INTRODUCTION ........... 10-8 PATIENT LIMIT ...................................... 7................................................................... 10-23 7................ 10-22 7.......................................................... 10-3 DATE/TIME SETTINGS .... Sysmex KX-21N Operator’s Manual -.............................. 10-36 FACTORY SETTINGS......................................................... 10-25 7............................................... 9........ 10-27 ID READER SETTINGS ............................................ 10.. 12........3 IP Output Settings............................................................................... 4..................................................................... 10-1 SYSTEM SETUP.......... 10-30 PASSWORD SETTINGS ............. 6............................... 11.......... 10-38 8...1 DP Output Settings................................... 3..............................October 1999 ......................................2 GP/LP Output Settings .............. 10-17 PRINTER SETTINGS...... 10-35 PERIPHERAL SETTINGS ................................................................... 10-14 HOST SETTINGS................................... INSTRUMENT SETUP 1. Patient Limit Sets upper and lower Patient Mark Limits to check for error in analysis data. and sets the output method of QC data. Date/Time Sets date/time of the built-in clock. Graphic Printer). CAUTION: • The setting program can be run only when the instrument is ready. Sysmex KX-21N Operator’s Manual -. The settings can be changed by using this program. This chapter describes how to use this setting program. handy barcode reader (option). Host Settings Sets the interface conditions for transferring data to the host computer. Peripheral Setting Sets whether to Use or Not Use of the printer. Password Settings Sets and changes the password. System Setup Sets up the instrument system status. ID Reader Settings Sets whether to Use or Not Use of the handy barcode reader (option). INTRODUCTION Your Sysmex service representative performs the settings of the instrument at time of installation. or the host computer output. QC Settings Selects between X control and L-J control as the QC method.October 1999 10-1 . Printer Settings Sets the output selection and output conditions of the built-in printer or the external printers (Data Printer. Print Set Values Prints all the contents of the settings by the built-in printer. (2) Direct key selection Using the numeric keys. enter a menu number of the program you want to set. The menu number is displayed on the Menu screen.INSTRUMENT SETUP NOTE: • Menu selection method (1) Cursor selection (explained in this Manual) Using [ ] or [ ] key.October 1999 . • 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 10-2 Sysmex KX-21N Operator’s Manual -. thus selecting the menu. This sets the settings. move the cursor to a desired program and press [ENTER] key to set. • 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. The Setting Menu screen appears. move the cursor to select "6: Settings. The Select Menu screen appears. (2) (3) Using [ ] or [ ] key. move the cursor to select "1: System Setup." Sysmex KX-21N Operator’s Manual -." Press [ENTER] key.October 1999 10-3 .INSTRUMENT SETUP 2. display language. SYSTEM SETUP This program is used to set unit system. and WBC analysis parameters. How to Setup System Status (1) Press [SELECT] key on the Analysis screen. *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. Figure 10-2-2: System Setup Screen NOTE: • When the password is set. and then press [ENTER] key (6) (7) (8) Using [ ] or [ ] key. Press [ENTER] key. three parameters can be set. and input the password. move the cursor to select the desired set parameter.October 1999 . The current setting status is displayed on the System Setup screen. The unit can be selected from the following six kinds: Settings Type 1 Type 2 Type 3 Unit System For Japan For General Export Canada SI Settings Type 4 Type 5 Type 6 Unit System Dutch SI Standard SI Hong Kong SI Table 10-2-1: Unit Setting 10-4 Sysmex KX-21N Operator’s Manual -. the content of settings changes. For System Setup. The content of settings is set and the cursor moves to the next set parameter. Each time you press the key.INSTRUMENT SETUP (5) Press [ENTER] key. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. *System Setup* Units Language Parameter Naming Type2 English LYM% Press [SELECT] to exit. Using [ ] or [ ] key. select the content of settings. the Password Input screen appears. 1) Unit Setting Sets the unit system for displaying analysis data. # × 10 9/L ###.# % ###.### L/L fL ###.# Kong SI Unit × 10 9/L ×1012/L g/dL fL pg g/dL × 10 9/L % % % × 10 9/L × 10 9/L × 10 9/L fL % fL fL % Item WBC RBC HGB HCT MCV MCH MCHC PLT LYM% MXD% NEUT% LYM# MXD# NEUT# RDW-SD RDW-CV MPV PDW P-LCR Table 10-2-2: Details of Unit System Sysmex KX-21N Operator’s Manual -.# ###.# g/dL #### × 10 3/ µ L ###.# × 10 2/ µ L #### × 10 2/ µ L #### × 10 2/ µ L #### fL ###.### Hong Decimal point ###.# % % ###.# pg ###.# × 10 9/L ###.# × 10 9/L ###.# × 10 9/L ###.### Canada SI Decimal Unit point ###.# ###.### ###.# #.# Standard SI Decimal Unit point ###.# pg #### g/L #### × 10 9/L #.# ###.# × 10 3/ µ L ###.# #### amol ###.# % ###.### × 10 9/L ###.# × 10 9/L ##.## ###.### × 10 9/L ###.# % ###.# fL ###.# × 10 9/L ###.# % ###.### #.# fL ###.## mmol/L ###.# fL ###.# fL ###.October 1999 10-5 .### #.# × 10 9/L ###.# #.# fL ###.### #.# pg ###.# fL ###.# mmol/L #### × 10 9/L #.# fL ###.### For General Export Decimal Unit point ###.# × 10 9/L ×1012/L ##.# #### ###.# #.## ×1012/L #### g/L #.# ###.# ###.# ###.### #.### #.### L/L ###.# % ###.# #. refer to the following table: Item WBC RBC HGB HCT MCV MCH MCHC PLT LYM% MXD% NEUT% LYM# MXD# NEUT# RDW-SD RDW-CV MPV PDW P-LCR For Japan Decimal Unit point #### × 10 2/ µ L × 10 4/ µ L #### g/dL ###.# #.# #.# % ###.# × 10 4/ µ L ###.# ###.# ##.# fL ###.# fL ###.# ###.# fL ###.# g/dL ###.# % ###.### #.# Dutch SI Decimal Unit point ###.# % ###.# ###.# × 10 3/ µ L ###.### fL ###.# % ###.# ###.### fL ###.# ###.# × 10 3/ µ L ###.# ###.## ×1012/L #### g/L #.# fL #.# % ###.INSTRUMENT SETUP For the detail of unit system.# g/dL ###.# × 10 9/L ##.# fL #.# × 10 3/ µ L ##.# fL ###.# × 10 9/L ###.# fL ###.### ###.## × 10 6/ µ L ###.### ###.# fL ###.### ###.# pg #### g/L #### × 10 9/L #.# fL ###. The parameter can be selected from the following two kinds: Settings W-SCR Analysis Parameter Name W-SCR W-MCR W-LCR W-SCC W-MCC W-LCC LYM% MXD% NEUT% LYM# MXD# NEUT# LYM% Table 10-2-4: Parameter Name Setting NOTE: • The settings of language become valid from the next time you turn ON the instrument power. The language can be selected from the eight kinds listed below: Settings Japanese English Chinese French German Spanish Italian Portuguese Display language Japanese English Chinese French German Spanish Italian Portuguese Table 10-2-3: Language Setting 3) Parameter Name Setting Set WBC analysis parameter names.INSTRUMENT SETUP 2) Language Setting Set the language for displaying on the screen. 10-6 Sysmex KX-21N Operator’s Manual -.October 1999 . Set Cancel Figure 10-2-3: Setting Change Confirmation Message (10) Using[ [Cont. move the cursor to select "Cont." or "Cancel.INSTRUMENT SETUP (9) When the setting of each parameter is completed. Change? Cont. Sysmex KX-21N Operator’s Manual -. Updates the settings and returns to the Analysis screen. press [SELECT] key. (11) Press [ENTER] to execute the selected process.October 1999 10-7 .]: [Set]: [Cancel]: ] or [ ] key.. Cancels the changed settings and returns to the Analysis screen." Returns to the System Setup screen. The Setting Change Confirmation message appears." "Set. And the setting operation can be continued. How to Set Date/Time (1) Press [SELECT] key on the Analysis screen.INSTRUMENT SETUP 3. move the cursor to select "2: Date/Time. move the cursor to select the desired set parameter. move the cursor to select "6: Settings. The Select Menu screen appears. using the built-in clock. DATE/TIME SETTINGS This instrument displays date/time on analysis data." Press [ENTER] key. (2) (3) Using [ ] or [ ] key. 10-8 Sysmex KX-21N Operator’s Manual -. *Date/Time* Date Format yy mm dd hh mm dd/mm/yyyy 1999 12 31 23 59 Press [SELECT] to exit. 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) (5) Using [ ] or [ ] key. The current setting status is displayed on the Date/Time screen. This program is used to set the date/time for the built-in clock and date format." Press [ENTER] key. Figure 10-3-2: Date/Time Screen (6) Using [ ] or [ ] key.October 1999 . 12 using the numeric keys. The content of the settings is set and the cursor moves to the next set parameter. month. Press [ENTER] key.INSTRUMENT SETUP (7) Using [ ]. hour. Year. Month Setting Enter the numerical value of 1 . In setting the date format. Settings yyyy/mm/dd mm/dd/yyyy dd/mm/yyyy Example of display 1999/12/31 12/31/1999 31/12/1999 Table 10-3-1: Date Format Setting 2) 3) 4) 5) Year Setting Enter in the dominical year using the numeric keys. select the date format. (8) NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings.31 using the numeric keys. and minute are entered using the numeric keys. set each parameter. 1) Date Format Setting Using [ ] or [ ] key. It changes each time you press the key. use [ ] or [ ] key.October 1999 10-9 . The date format can be selected from the following three types.23 by 24-hour system with using the numeric keys Minute Setting Enter the numerical value of 0 . Hour Setting Enter the numerical value of 0 .59 using the numeric keys 6) Sysmex KX-21N Operator’s Manual -. Day Setting Enter the numerical value of 1 . or the numeric keys. [ ]. day. press [SELECT] key. 10-10 Sysmex KX-21N Operator’s Manual -. move the cursor to select "Cont." or "Cancel. [Set]: Updates the settings and returns to the Analysis screen.]: Returns to the Date/Time screen. e.October 1999 . The date entered is checked and when there is no setting error. the Setting Change Confirmation message is displayed. the following items are checked: Leap year check: whether 2/29 is set in non-leap year Month/day check: whether 4/31. (11) Press [ENTER] key to execute the selected process. is set Change? Cont." "Set.. And the setting operation can be continued. Set Cancel Figure 10-3-3: Setting Change Confirmation Message (10) Using [ ] or [ ] key. the alarm sounds and the Setting Change Confirmation message is not displayed.g.. If there is any setting error. NOTE: • About the date setting.INSTRUMENT SETUP (9) When the setting of each parameter is completed. [Cancel]: Cancels the changed settings and returns to the Analysis screen." [Cont. The Setting Menu screen appears. you can set Mark Limits." Press [ENTER] key. *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. This program can be used to set the upper and lower Mark Limits for each analysis parameter. move the cursor to select "3: Patient Limit. The Mark Limits are the values set to determine whether analysis values are within the normal range or not. and when it exceeds the lower Mark Limit. move the cursor to select "6: Settings. PATIENT LIMIT For Patient Limit. (2) (3) Using [ ] or [ ] key." Sysmex KX-21N Operator’s Manual -. it is flagged with [+] mark.October 1999 10-11 . Analysis data output to the built-in printer or the host computer is also attached with either marks. When analysis data exceeds the upper Mark Limit. it is flagged with [-] mark. How to Set Mark Limits (1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.INSTRUMENT SETUP 4. *Patient Limit* WBC RBC HGB HCT MCV MCH MCHC PLT LYM% MXD% LL 3. and then press [ENTER] key (6) Using [ ] or [ ] key.0 95. *Patient Limit* MXD% NEUT% LYM# MXD# NEUT# RDW-SD RDW-CV PDW MPV P-LCR LL 1.50 17.October 1999 .0 UL 15.0 9.0 0 0 0 54.INSTRUMENT SETUP (5) Press [ENTER] key.0 20.50 8. But not all of them can be displayed in one screen at a time.0 UL 20.0 86.0 50 5.0 110. move the cursor to select the desired set parameter.0 1.0 % % ×1 03/µL ×1 03/µL ×1 03/µL fL % % fL % Press [SELECT] to exit. scroll the screen using [ ] or [ ] key.0 50.0 2. Figure 10-4-2: Patient Limit Screen NOTE: • When the password is set.0 38.0 43. move the cursor to select LL (Lower Limit) or UL (Upper 10-12 Sysmex KX-21N Operator’s Manual -.0 17.0 45.0 0 0 0 37.0 400 55.0 13.0 26. and input the password. ] or [ ] key. NOTE: • Total 19 setting parameters of Patient Limit are displayed.0 31.0 13.0 ×1 03/µL ×1 06/µL g/dL % fL pg g/dL ×1 03/µL % % Press [SELECT] to exit. the Password Input screen appears.0 9.0 26.0 11. The current setting status is displayed on the Patient Limit screen. Figure 10-4-3: Scrolling the Screen (7) Using [ Limit). Therefore.0 16.0 37.0 5. the contents of settings are also set. • When both the upper and lower limits are set at "0. Change? Cont. move the cursor to select "Cont. [Cancel]: Cancels the changed settings and returns to the Analysis screen." [Cont. press [SELECT] key." the judgment on patient limit is not executed. [Set]: Updates the settings and returns to the Analysis screen. And the setting operation can be continued. In case Upper Limit < Lower Limit is set.. (10) When the setting of each parameter is completed. NOTE: • When [ ]. Sysmex KX-21N Operator’s Manual -. or [ ] key is pressed after entering.October 1999 10-13 . (12) Press [ENTER] key to execute the selected process. the alarm sounds and the Setting Change Confirmation message is not displayed. [ ]. Set Cancel Figure 10-4-4: Setting Change Confirmation Message (11) Using [ ] or [ ] key.INSTRUMENT SETUP (8) (9) Enter the settings using the numeric keys." "Set. [ ]. Press [ENTER] key.]: Returns to the Patient Limit screen. The content of settings is set and the cursor moves to the next set parameter. the Setting Change Confirmation message is displayed. When the set values are checked and there is no setting error." or "Cancel. (2) (3) Using [ ] or [ ] key. Select either of them that suits your purpose.INSTRUMENT SETUP 5. L-J Control: How to Set QC Settings (1) Press [SELECT] key on the Analysis screen. X Control: Control blood is subjected to two consecutive analyses and the mean of them is used as the QC data. QC SETTINGS This program is used to set QC method and output method of QC data. move the cursor to select "6: Settings." 10-14 Sysmex KX-21N Operator’s Manual -. *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." Press [ENTER] key. The Select Menu screen appears. Two kinds of QC methods are available with this instrument: X control and L-J control. The control width in the L-J control is prone to influence in reproducibility in analysis. move the cursor to select "4: QC Settings. The Setting Menu screen appears.October 1999 . This method causes little influence on reproducibility in analysis. This control uses the data from a single analysis of control blood as QC data. so that the control width is wider than in the case of X control. the Password Input screen appears.October 1999 10-15 . select the content of settings. Press [ENTER] key. *QC Settings* QC Method Data Output X Print Press [SELECT] to exit. QC settings can be made on three parameters. 1) QC Method Setting Set the QC method. and then press [ENTER] key (6) (7) (8) Using [ ] or [ ] key. move the cursor to select the set parameter. The content of settings changes each time you press the key. Using [ ] or [ ] key. and input the password.INSTRUMENT SETUP (5) Press [ENTER] key. The QC method can be selected from the following two kinds: 17 Settings X L-J QC Method X Control L-J Control Table 10-5-1: QC Method Setting Sysmex KX-21N Operator’s Manual -. The current setting status is displayed on the QC Settings screen. Figure 10-5-2: QC Settings Screen NOTE: • When the password is set. 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. The QC data output can be selected from the following four kinds: Settings None Print Host Print. [Cancel]: Cancels the changed settings and returns to the Analysis screen. refer to Appendix B: Technical Information. Host QC data output Not output Print on built-in printer Output to host computer 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. Section 2. (11) Press [ENTER] key to execute the selected process. (9) When the setting for each parameter is completed. press [SELECT] key.6: Execute X Control or Chapter 5." [Cont..INSTRUMENT SETUP 2) Data Output Setting Set the QC data output method.7: Execute L-J Control. • For output format to the host computer. refer to Chapter 5.October 1999 . [Set]: Updates the settings and returns to the Analysis screen.]: Returns to the QC Settings screen." "Set. • The data output format for quality control differs from the format for usual analysis. 10-16 Sysmex KX-21N Operator’s Manual -. move the cursor to select "Cont. Change? Cont. Section 2. Set Cancel Figure 10-5-3: Setting Change Confirmation Message (10) Using [ ] or [ ] key. The Setting Change Confirmation message appears. And the setting operation can be continued." or "Cancel. " Press [ENTER] key. *Host Settings* Connect Output Format Auto Output Baud Rate Data Length Stop Bit Parity Check Protocol Interval RTS/CTS Not Use K-1000 On 2400 7bits 2bits Even Class A 2 Ignore Press [SELECT] to exit. 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) (5) Using [ ] or [ ] key. The current setting status is displayed on the Host Settings screen. Figure 10-6-2: Host Settings Screen Sysmex KX-21N Operator’s Manual -. (2) (3) Using [ ] or [ ] key." Press [ENTER] key. HOST SETTINGS This program is used to set the interface conditions for transferring data to the host computer.INSTRUMENT SETUP 6. The Select Menu screen appears. How to Set Host Output (1) Press [SELECT] key on the Analysis screen.October 1999 10-17 . move the cursor to select "6: Settings. move the cursor to select "5: Host Settings. The content of settings is set and the cursor moves to the next set parameter. NOTE: • There are 12 setting parameters for Host Settings. select the condition. Figure 10-6-3: Host Settings Screen (7) (8) Using [ ] or [ press the key.INSTRUMENT SETUP (6) Using [ ] or [ ] key. *Host Settings* RDW Output ID Padding RDW-CV 0 Padding Press [SELECT] to exit. 1) Connect Settings Set whether to connect the host computer or not. so scroll the screen with [ ] key or [ ] key. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. For Host Settings. move the cursor to select the desired set parameter. but all the setting parameters cannot be listed in one screen. The condition changes each time you Press [ENTER] key. eight parameters can be set.October 1999 . ] key. Settings Use Not Use Connection Connect Not Connect Table 10-6-1: Host Output Settings 10-18 Sysmex KX-21N Operator’s Manual -. ASCII data is output in the published format. Binary data is output for connecting with K-DPS. Refer to Appendix B: Technical Information.October 1999 10-19 . Data format is not published. Settings On Off Auto Output Auto Output Not Auto Output Table 10-6-3: Auto Output Settings 4) Baud Rate Settings Set the baud rate.INSTRUMENT SETUP 2) Output Format Settings Set output format of analysis data to the host computer. This can be selected from the following two kinds: Settings 7 bits 8 bits Data Length 7 bits 8 bits Table 10-6-5: Data Length Settings Sysmex KX-21N Operator’s Manual -. Table 10-6-2: Output Format Settings 3) Auto Output Settings Set whether to make auto output to the host computer or not. This can be selected from the following four kinds: Settings 1200 2400 4800 9600 1200 2400 4800 9600 Baud Rate bps bps bps bps Table 10-6-4: Baud Rate Settings 5) Data Length Settings Set the data length. This can be selected from the following three kinds: Settings KX-21N K-1000 K-DPS Output Format Standard output format of KX-21N Refer to Appendix B: Technical Information. This can be set selected from the following two kinds: Settings 1 bit 2 bits 1 bit 2 bits Stop Bit Table 10-6-6: Stop Bit Settings 7) Parity Check Settings Set the parity check method. This can be set selected from the following two kinds: Settings Class A Class B Protocol Class A Class B Table 10-6-8: Protocol Settings 9) Transmission interval Settings Select a transmission interval from the following: Settings 0 2 3 5 7 10 15 Interval 0 second 2 seconds 3 seconds 5 seconds 7 seconds 10 seconds 15 seconds Table 10-6-9: Transmission Interval 10-20 Sysmex KX-21N Operator’s Manual -.October 1999 . This can be set selected from the following three kinds: Settings None Odd Even Parity Check None Odd Even Table 10-6-7: Parity Check Settings 8) Protocol Settings Set the protocol.INSTRUMENT SETUP 6) Stop Bit Settings Set the stop bit. " [Cont. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (11) Press [ENTER] key to execute the selected process. Settings RDW-SD RDW-CV RDW Output Outputs RDW-SD Outputs RDW-CV Table 10-6-11: RDW Output 1 2 ) ID Padding It can be set whether to make the sample ID padding by selecting from following two types.October 1999 10-21 . Change? Cont.. [Set]: Updates the settings and returns to the Analysis screen. The Setting Change Confirmation message appears.INSTRUMENT SETUP 1 0 ) RTS/CTS control Settings Specify whether or not the RTS/CTS flow control takes place." "Set. And the setting operation can be continued. press [SELECT] key." or "Cancel. Settings 0 Padding None Padding Allowed 0 padding Not allowed 0 padding Table 10-6-12: ID Padding (9) When the setting of each parameter is completed.]: Returns to the Host Settings screen. move the cursor to select "Cont. Sysmex KX-21N Operator’s Manual -. Set Cancel Figure 10-6-4: Setting Change Confirmation Message (10) Using [ ] or [ ] key. Settings Refer Ignore RTS/CTS control Allowed Not allowed Table 10-6-10: RTS/CTS control 1 1 ) RDW Output RDW Output can be set by selecting from following two types. " Press [ENTER] key. Graphic Printer). move the cursor to select "6: Printer Settings. (2) (3) Using [ ] or [ ] key. How to Set Printer Output (1) Press [SELECT] key on the Analysis screen. *Settings* 1 : DP 2 : GP/LP 3 : IP Figure 10-7-2: Printer Settings Menu Screen NOTE: • When you press [ENTER] key on this screen. 10-22 Sysmex KX-21N Operator’s Manual -.October 1999 . *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 10-7-1: Setting Menu Screen (4) (5) Using [ ] or [ ] key. The Printer Settings Menu screen appears. The Select Menu screen appears. move the cursor to select "6: Settings. The Setting Menu screen appears. 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. the screen returns to the Analysis screen.INSTRUMENT SETUP 7." Press [ENTER] key. *DP* Connect DP Auto Output Use On Press [SELECT] to exit. The content of settings changes each time you press the key. 1 DP Output Settings Select "1: DP" on Printer Settings Menu screen and press [ENTER] key. Figure 10-7-3: DP Settings Screen (1) (2) (3) Using [[ ] or [ ] key. you can set two parameters.1: DP Output Settings in this chapter. Using [ ] or [ ] key. For how to set the printer output of IP (Built-in Printer). refer to Section 7. 7 . The content of setting is set and the cursor moves to the next analysis parameter. Press [ENTER] key. move the cursor to select the desired setting parameter. select the content of settings. Sysmex KX-21N Operator’s Manual -.2: GP/LP Output Settings in this chapter. refer to Section 7.3: IP Output Settings in this chapter. For how to set the printer output of GP/LP (Graphic Printer). For how to set the printer output of DP (Data Printer). The Printer Settings screen for the selected printer appears. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings.October 1999 10-23 . In the output setting for the data printer. Press [ENTER] key. The DP Settings screen for Data Printer appears. move the cursor and select the printer to be set.INSTRUMENT SETUP (6) (7) Using [ ] or [ ] key. refer to Section 7. October 1999 . [Cancel]: Cancels the changed settings and returns to the Analysis screen. move the cursor to select "Cont. Press [ENTER] key to execute the selected process. Change? Cont. Set Cancel Figure 10-7-4: Setting Change Confirmation Message (5) Using [ ] or [ ] key. And the setting operation can be continued." or "Cancel. Settings Use Not Use Connection Connect 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. [Set]: Updates the settings and returns to the Analysis screen.." [Cont. press [SELECT] key. The Setting Change Confirmation message appears. Settings On Off Auto Output Auto Output Not Auto Output Table 10-7-2: Auto Output Settings (4) When the setting of each parameter is completed.INSTRUMENT SETUP 1) Connect Settings Set whether to use the data printer or not.]: Returns to the DP Settings screen." "Set. (6) 10-24 Sysmex KX-21N Operator’s Manual -. Settings Use Not Use Connection Connect Not Connect Table 10-7-3: Graphic Printer Settings Sysmex KX-21N Operator’s Manual -. you can set three parameters. *GP/LP* Connect Printer type GP Auto Output Use Type1 On Press [SELECT] to exit. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. select the condition.October 1999 10-25 . The GP/LP Settings screen for Graphics Printer appears. move the cursor to select the desired setting parameter. The content of setting is set and the cursor moves to the next analysis parameter. Using [ ] or [ ] key.INSTRUMENT SETUP 7 . In the output setting for the data printer. 2 GP/LP Output Settings Select "2: GP/LP" on Printer Settings Menu screen and press [ENTER] key. The condition changes each time you press the key. 1) Connect Settings Set whether to use the graphic printer or not. Press [ENTER] key. Figure 10-7-5: GP/LP Settings Screen (1) (2) (3) Using [[ ] or [ ] key. [Cancel]: Cancels the changed settings and returns to the Analysis screen. And the setting operation can be continued." "Set. [Set]: Updates the settings and returns to the Analysis screen. Settings Type 1 Type 2 Printer type Printer of ESC/P system 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. Press [ENTER] key to execute the selected process. Set Cancel Figure 10-7-6: Setting Change Confirmation Message (5) Using [ ] or [ ] key. move the cursor to select "Cont.INSTRUMENT SETUP 2) Printer type Settings The type of graphic printer to be connected can be set by selecting from following two types. Settings On Off Auto Output Auto Output Not Auto Output Table 10-7-5: Auto Output Settings (4) When the setting of each parameter is completed. press [SELECT] key." [Cont. The Setting Change Confirmation message appears. Change? Cont..October 1999 . (6) 10-26 Sysmex KX-21N Operator’s Manual -.]: Returns to the GP/LP Settings screen." or "Cancel. 1) Connect Settings Set whether to use the built-in printer or not.INSTRUMENT SETUP 7 . The content of settings is set and the cursor moves to the next set parameter. The IP Settings screen for Built-in Printer appears. Press [ENTER] key.October 1999 10-27 . NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. Figure 10-7-7: IP Settings Screen (1) (2) (3) Using [ ] or [ ] key. move the cursor to select the set parameter. 3 IP Output Settings Select "3: IP" on Printer Settings Menu screen and press [ENTER] key. Printer settings can be made on three parameters. Settings Use Not Use Connection Connect Not Connect Table 10-7-6: Built-in Printer Settings Sysmex KX-21N Operator’s Manual -. *IP* Connect Print Condition Print Format Use All Data Type1 Press [SELECT] to exit. select the condition. The condition changes each time you press the key. Using [ ] or [ ] key. Section 5: QC Settings. refer to Chapter 5. Section 5. • For print format for quality control. Print 8 parameters. Table 10-7-8: Print Format Settings NOTE: • For print format. • 3) Print Format Settings Set the print format for the built-in printer.2 Printing of Analysis Result.7: Execute L-J Control. Section 2. 10-28 Sysmex KX-21N Operator’s Manual -.6: Execute X Control or Chapter 5. Print 19 parameters. This can be selected from the following three kinds: Settings Type 1 Type 2 Type 3 Print Format Print 19 parameters + histograms.INSTRUMENT SETUP 2) Print Condition Settings Set the auto print condition for the built-in printer. refer to Chapter 2. Section 2. refer to Chapter 10. This can be selected from the following three kinds: Settings All Data Abnormal Data None Auto Print Conditions Print All Samples Print Abnormal Data Only 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.October 1999 . " "Set.October 1999 10-29 . [Set]: Updates the settings and returns to the Analysis screen.INSTRUMENT SETUP (4) When the setting of each parameter is completed. Change? Cont. Press [ENTER] key to execute the selected process. move the cursor to select "Cont. press [SELECT] key. (6) Sysmex KX-21N Operator’s Manual -. The Setting Change Confirmation message appears." [Cont.]: Returns to the Printer Settings screen. And the setting operation can be continued. [Cancel]: Cancels the changed settings and returns to the Analysis screen." or "Cancel. Set Cancel Figure 10-7-8: Setting Change Confirmation Message (5) Using [ ] or [ ] key.. move the cursor to select "6: Settings. The current setting status appears on ID Reader Settings screen. The Setting Menu screen appears.INSTRUMENT SETUP 8. *IP Reader* Connect Use Press [SELECT] to exit.October 1999 . How to Set ID Reader (1) Press [SELECT] key on the Analysis screen. move the cursor to select "7: ID Reader Settings. *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) (5) Using [ ] or [ ] key." Press [ENTER] key. (2) (3) Using [ ] or [ ] key. The Select Menu screen appears. Figure 10-8-2: ID Reader Settings Screen 10-30 Sysmex KX-21N Operator’s Manual -. ID READER SETTINGS This program can set whether to Use or Not Use of the handy barcode reader (option) which is for reading the sample IDs." Press [ENTER] key. " [Cont. Change? Cont. [Cancel]: Cancels the changed settings and returns to the Analysis screen. And the setting operation can be continued." or "Cancel.]: Returns to the Printer Settings screen. move the cursor to select "Cont. [Set]: Updates the settings and returns to the Analysis screen. Sysmex KX-21N Operator’s Manual -. The Setting Change Confirmation message appears.." The display of "Use" and "Not Use" changes whenever the key is pressed. Press [ENTER] key.INSTRUMENT SETUP (6) (7) (8) Using [ ] or [ ] key. Press [SELECT] key." "Set. (10) Press [ENTER] key to execute the selected process. Set Cancel Figure 10-8-3: Setting Change Confirmation Message (9) Using [ ] or [ ] key. select "Use" or "Not Use.October 1999 10-31 . The setting contents can be confirmed. *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." 10-32 Sysmex KX-21N Operator’s Manual -. Section 14: MENU TREE. the Password Input window appears.INSTRUMENT SETUP 9. • When the program protected by the password is executed. When the set password is input." Press [ENTER] key. (2) (3) Using [ ] or [ ] key. NOTE: • In order to execute under the control of the instrument manager. an important program is protected by the password. refer to Chapter 1. and [ENTER] key is pressed. the program is executed. move the cursor to select "8: Password Settings. • For the programs protected by the password. The Select Menu screen appears. PASSWORD SETTINGS This program can set and change the password. move the cursor to select "6: Settings. The Setting Menu screen appears. How to Set Password (1) Press [SELECT] key on the Analysis screen.October 1999 . Sysmex KX-21N Operator’s Manual -. and then input a correct password.INSTRUMENT SETUP (5) Press [ENTER] key. *Password* Password [ ] Press [SELECT] to exit. • On the screen. Figure 10-9-2: Password Settings Screen NOTE: • When you have already set the password. The Password Settings screen appears. and pressing [ENTER] key. *Password* New Password [ Enter Again [ ] ] Press [SELECT] to exit.October 1999 10-33 . and to return to Analysis screen. all the values of the password display part are displayed by "*". the Password Settings screen appears. the Password Input screen is displayed. The purpose of this is to make other people not seen the password when setting it. Figure 10-9-3: Password Input Screen In the input of a correct password. • Press [SELECT] key to discontinue the password setting. [Cancel]: Cancels the changed settings and returns to the Analysis screen. (7) Again. Change? Cont.October 1999 . input the set password to the Enter Again column with numeric keys. and press [ENTER] key. and press [ENTER] key. If [ENTER] key is pressed. If they are the same." or "Cancel. Set Cancel Figure 10-9-4: Setting Change Confirmation Message (8) Using [ ] or [ ] key. Press [ENTER] key. NOTE: • When you do not set the password. move the cursor to select "Cont." "Set. The Setting Menu screen appears. set over again from the input of the New Password column.]: Returns to the Printer Settings screen. Set the password up to 10 digits by using the figure (0-9) or the hyphen (-). (9) 10-34 Sysmex KX-21N Operator’s Manual -. If the password input to the New Password column and the password input to the Enter Again are different. the password can be deleted by the following operating.. the Setting Change Confirmation message appears. the status becomes the input waiting for the Enter Again column. And the setting operation can be continued.INSTRUMENT SETUP (6) Input the set password to the New Password column with numeric keys." [Cont. [Set]: Updates the settings and returns to the Analysis screen. • Press [ENTER] key at the status of no password input. move the cursor to select "9: Print Set Values. The Setting Menu screen appears." Press [ENTER] key. Keep the printed contents of the settings in good condition because the service representative may have to confirm the contents of settings. all the contents of the settings can be printed by the built-in printer. The Select Menu screen appears. (2) (3) Using [ ] or [ ] key.October 1999 10-35 .INSTRUMENT SETUP 1 0 . The built-in printer starts printing all the set values. How to Print Set Values (1) Press [SELECT] key on the Analysis screen. move the cursor to select "6: Settings. contact your Sysmex service representative." Press [ENTER] key. PRINT SET VALUES To backup the set values. *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) (5) Using [ ] or [ ] key. NOTE: • If any faulty operation occurs. Sysmex KX-21N Operator’s Manual -. The Select Menu screen appears.Settings* Data Printer Graphic Printer Printer (Roll) Host Output ID Reader Press [SELECT] to exit. Use Use Use Use Use Figure 10-11-2: Peripheral Settings Screen 10-36 Sysmex KX-21N Operator’s Manual -. move the cursor to select "8: Periph. Settings. refer to "5: "Host Settings" and "6: Printer Settings" which carry description of similar settings. *SELECT* 1:Stored Data 2:Quality Control 3:Calibration 4:Replace Lyse 5:Auto Rinse 6:Settings 7:Maintenance 8:Periph. 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. Settings 00:PU Sleep Figure 10-11-1: Select Menu Screen (2) (3) Using [ ] or [ ] key. This displays connection status of external devices on the Peripheral Settings screen. *Periph." Press [ENTER] key. host computer output or the handy barcode reader. How to Set Peripheral Connection (1) Press [SELECT] key on the Analysis screen.INSTRUMENT SETUP 1 1 . NOTE: • For peripheral settings.October 1999 . [Cancel]: Cancels the changed settings and returns to the Analysis screen. move the cursor to select the desired external device. (7) Press [SELECT] key. move the cursor to select "Cont." [Cont.." or "Cancel. Using [ ] or [ ] key. Change? Cont. "Use" and "Not Use" change over each time you press the key. select "Use" or "Not Use".]: Returns to the Peripheral Settings screen. Press [ENTER] key. The Setting Change Confirmation message appears. And the setting operation can be continued. The content of the settings is set and moves the cursor to the next set parameter.INSTRUMENT SETUP (4) (5) (6) Using [ ] or [ ] key. Set Cancel Figure 10-11-3: Setting Change Confirmation Message (8) Using [ ] or [ ] key." "Set. (9) Sysmex KX-21N Operator’s Manual -. NOTE: • The settings can also be set when you press [ ] or [ ] key after changing the content of settings. [Set]: Updates the settings and returns to the Analysis screen. Press [ENTER] key to execute the selected process.October 1999 10-37 . 0 20.0 13.0 26.0 400 55.0 45.0 0 0 0 54.0 9.0 50.0 86.0 37.0 16.0 L-J Print Not use KX-21N Off 2400 bps 7 bits 2 bits Even Class A 2 Ignore RDW-CV 0 Padding UL 15.0 95.INSTRUMENT SETUP 1 2 .0 9.0 1.50 8.October 1999 .0 50 5.0 38.0 43.0 110.50 17.0 31.0 10-38 Sysmex KX-21N Operator’s Manual -.0 13.0 26.0 11.0 17.0 2.0 0 0 0 37. FACTORY SETTINGS The settings made at the factory are listed below: • System Settings Units Language Parameter Naming • Date/Time Date Format • Patient Limits WBC RBC HGB HCT MCV MCH MCHC PLT LYM% MXD% NEUT% LYM# MXD# NEUT# RDW-SD RDW-CV PDW MPV P-LCR • QC Settings QC Method Data Output • Host Settings Connect Output format Auto Output Baud Rate Data Length Stop Bit Parity Check Protocol Interval RTX/CTS RDW Output ID Padding Type 2 English LYM% dd/mm/yyyy LL 3.0 5. INSTRUMENT SETUP • 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 -.October 1999 10-39 . ......... A-12 7.................October 1999 ........................ A-12 TURN POWER ON ...................................... A-13 REINSTALLING THE PROGRAM ................................. A-10 CONNECT POWER CORD AND CONNECTING CABLES......2 Connect Power Cord ............................ A-13 6...... A-12 7....... 4....1 Connect Host Computer...................A-6 5..................... Printer.............A-1 CHECK BEFORE INSTALLATION ..... 5....................A-3 REMOVE SHIPPING CLAMPS ..............................2 Connect CELLPACK........................A-6 5.....................A-6 5.. and Handy Barcode Reader.....................3 Connect STROMATOLYSER-WH.. Sysmex KX-21N Operator’s Manual -.............................. 7............A-4 CONNECT TUBE ................A-9 SET PRINTER PAPER (OPTION).....................................................A-8 5.............. INTRODUCTION ................................ 3.................................................................................................................................. 8....................... 9.INSTALLATION APPENDIX A: INSTALLATION 1........................A-2 INSTALLATION SPACE ...................................... 2.....................1 Prepare Reagent ..............4 Connect Waste Line.......................................................................... INSTALLATION 1. contact your Sysmex service representative. installing. NOTE: • When the optional external printers (Data Printer and Graphic Printer) or Handy Barcode Reader is intended to incorporate to this instrument. Sysmex KX-21N Operator’s Manual -. The next several pages will give some essential information on this instrument.October 1999 A -1 . Sysmex representative is responsible for unpacking. INTRODUCTION This product is a clinical test instrument. and initial setup of the product to ensure its proper and safe operation. 4 (973-3041-7 Float Switch No. Q'ty 220 V 0 1 1 1 1 1 3m 6m 2 1 2 1 1 No.INSTALLATION 2. Amer) Power Cord 4622-007-0092 (Europe) Power Cord No. 20 Tube Polyurethane 4 mm ID × 6 mm OD Tube Polyurethane 6 mm ID × 9 mm OD Mini Pipette No. 7650 (U.October 1999 .170 117 V 1 0 1 1 1 1 3m 6m 2 1 2 1 1 240 V 0 1 1 1 1 1 3m 6m 2 1 2 1 1 Table A-2-1: KX-21N Unpacking Checklist NOTE: • Item No. 15 (C-2/N.K. 1 Float Switch No.5W Caution Mark No. 23) is pre-installed in the Main Unit Front Interior at the factory. 1 Assy Fuse 250V 3. 1 1 2 2 2 3 4 5 6 7 8 9 10 10 11 12 Part No.) Cubitainer Spout Kit No.15A-N1 Fuse 250V 2A No. 19195 (Europe) Clamp LWS-8S-2. CHECK BEFORE INSTALLATION Make sure the KX-21N is free from external damages and check the quantities of the accessories. 461-2264-1 461-2265-5 923-8092-8 265-4719-0 265-4728-3 943-1781-1 973-3041-7 367-1051-9 442-5338-7 442-5340-5 423-1776-2 933-3601-9 266-5109-1 266-5292-6 266-6743-4 369-8234-6 Description Operator's Manual KX-21N (North American) Operator's Manual KX-21N (English) Power Cord No.15A ST4-3. 10 (1 mL) Brush No. A -2 Sysmex KX-21N Operator’s Manual -. 23 Tray No. • Select a place where the power supply is located close. Each dimension of the instrument is shown below.October 1999 A -3 . You may need some more desktop space if optional Data Printer and Graphic Printer are provided.8 m long. INSTALLATION SPACE To ensure that the instrument performs to its full extent.INSTALLATION 3. • Secure a space for maintenance and service. it should be installed at an appropriate place. provide at least 50 cm clearance between the wall and the instrument's side rear. Width (mm) 420 Depth (mm) 355 Height (mm) 480 Weight (kg) 30 Main Unit Table A-3-1: Instrument Dimensions 480 420 355 Figure A-3-1: Instrument Dimensions Sysmex KX-21N Operator’s Manual -. and top panels. Giving consideration to heat radiation by the instrument. The power cord is 1. 1) Remove the SRV fixing screw.October 1999 . SRV Fixing Screw Tray No. Figure A-4-1: Removing the Tape (2) (3) Open the front cover of the main unit. 3) Return the valves and the SRV fixing screw to their original positions. Remove the protection sheets of the sampling valve. 2) With the fixed and rotary valves separated sufficiently. 4) Set the provided sample rotor valve tray. REMOVE SHIPPING CLAMPS (1) Peel off the fixing tape of the outer cover gently. 20 Protection Sheets Figure A-4-2: Removing the Protection Sheets A -4 Sysmex KX-21N Operator’s Manual -.INSTALLATION 4. remove the protection sheets. Keep these screws for future use. Rubber Caps Figure A-4-4: Removing the Rubber Caps Sysmex KX-21N Operator’s Manual -. Keep these rubber caps for future use.INSTALLATION (4) Remove the pneumatic unit fixing screws (2 pcs). Fixing Screws Figure A-4-3: Removing the Screws (5) Remove the rubber caps of the reagent connection nipples.October 1999 A -5 . October 1999 . 1 with the tube polyurethane 4 mmID × 6 mmOD. and connect it. 2 Connect CELLPACK (1) Prepare the following reagent tube. 1 CE LL PA CK Figure A-5-1: Setting the Cubitainer Spout Kit A -6 Sysmex KX-21N Operator’s Manual -. Tube Polyurethane 4 mmID × 6 mmOD : 1 pc • Cut the tube to an appropriate length. CONNECT TUBE 5 . Cap Cubitainer Spout Kit No. 884-0871-1 974-0521-6 Type PK-30L SWH-200A Part Name CELLPACK STROMATOLYSER-WH Connection Kit Cubitainer spout kit No. 1 (for 20L) Float switch No. 1 Prepare Reagent Prepare the reagents and connection kits shown below.INSTALLATION 5. NOTE: (2) (3) Connect the diluent (CELLPACK) inlet aspiration nipple behind the unit and the nipple of the cubitainer spout kit No. Set the cubitainer spout kit No. 1 to the CELLPACK container. 23 5 . Reagent Part No. INSTALLATION Diluent Inlet Nipple Tube Polyurethane 4 mmID × 6 mmOD Cubitainer Spout Kit No. wash it off immediately using plenty of water. reagent may flow into the vacuum line. wash it off using plenty of water. 1 CELLPACK Figure A-5-2: Connecting the CELLPACK • Take care not to spill a reagent on to the instrument. Use up CELLPACK within 60 days from the unpacking date. If it spills. • If it happens to adhere to your skin. Avoid setting CELLPACK at a level higher than the instrument. Sysmex KX-21N Operator’s Manual -. wipe it off immediately using a wet cloth or the like. be sure not to allow dust or dirt to come into the instrument. do not pull it by force for reagent replacement. CAUTION: • After connecting the tube. and take medical treatment at once. CAUTION CAUTION: • When the diluent (CELLPACK) tube is more than 2 m long.October 1999 A -7 . it may be impossible to have reagent aspirated. • If a reagent happens to enter your eye. • After unpacking. and STROMATOLYSER-WH within 90 days. otherwise. possibly damaging the instrument. October 1999 . Install the float switch No. 23 to STROMATOLYSER-WH. set it to the table. 3 Connect STROMATOLYSER-WH (1) (2) Gently remove the provided float switch No.INSTALLATION 5 . Then. 23 from the dust-protection bag. Float switch No. 23 STROMATOLYSER-WH Figure A-5-3: Installing the STROMATOLYSER-WH A -8 Sysmex KX-21N Operator’s Manual -. Tube Polyurethane 6 mmID × 9 mmOD : 1 pc Connect an end of the tube polyurethane 6 mmID × 9 mmOD to the drain outlet nipple behind the unit. (3) Arrange and tie the diluent and waste line tubings as shown in the figure using the provided clamp. • Since waste is removed from the system by pressurized air. The maximum waste line length is 6 m.INSTALLATION 5 . the waste tank may be located at the same height as. If the waste sewer is not available. Otherwise the waste may be flown back into the system. Connect the other end of the tube to the waste sewer in the lab. Diluent Inlet Nipple Drain Outlet Nipple Tube Polyurethane 6 mmID × 9 mmOD Waste Sewer or Waste Tank Clamp Figure A-5-4: Connecting the Waste Line and Clamping Tubings Sysmex KX-21N Operator’s Manual -. NOTE: • Cut the tube to an appropriate length. or lower than. and connect it. 4 Connect Waste Line (1) (2) Prepare the following waste line tube. the drain outlet nipple.October 1999 A -9 . which will result of a malfunction. connect it to a waste tank. October 1999 . Turn the release lever up to free the paper. Release Lever Figure A-6-1: Releasing the Lever (3) Mount a printer paper.INSTALLATION 6. Printer Paper Figure A-6-2: Mounting a Printer Paper A -10 Sysmex KX-21N Operator’s Manual -. (1) (2) SET PRINTER PAPER (OPTION) Open the front cover of the main unit. Figure A-6-4: Cutting Off Paper (6) Close the front cover of the main unit. Figure A-6-3: Securing the Release Lever (5) Cut off any printer paper extending from the upper part of the printer.INSTALLATION (4) Pass the printer paper as shown below. Sysmex KX-21N Operator’s Manual -. and turn the release lever down to secure.October 1999 A -11 . Printer. 1 Connect Host Computer.INSTALLATION 7. 2 Connect Power Cord Connect the provided power cord to the power supply outlet. Section 8: ID READER SETTINGS to use the connected external instruments. Section 6: HOST SETTINGS. Chapter 10. and Handy Barcode Reader Connect to each instrument with connecting cables. Power Cord Connect to the Power Supply Outlet Figure A-7-2: Connecting the Power Cord A -12 Sysmex KX-21N Operator’s Manual -. CONNECT POWER CORD AND CONNECTING CABLES 7 . Section 7: PRINTER SETTINGS or Chapter 10.October 1999 . 7 . 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. When the installation is completed. and open the card slot protective cover. and turn ON the power. reinstall the program according to the following procedures. press [1] key. when there is necessary for reinstalling the program by the disorder etc. the message of "Installation was successful" will be displayed. TURN POWER ON It is necessary to run the service sequence at the initial start-up. (6) (7) Sysmex KX-21N Operator’s Manual -. When "*Program Upgrade*" is displayed on the screen. Close the card slot protective cover. 9. (1) (2) (3) (4) (5) Turn OFF the power of the main unit. of the hardware. Turn OFF the power. Loosen the screws of the card slot protective cover on the rear panel.INSTALLATION 8. Insert the program card in the card slot. REINSTALLING THE PROGRAM The program is installed in the KX-21N beforehand but. and extract the program card. Your Sysmex service representative is responsible for the operation. Close the card slot protective cover. and then install the program. and turn ON the power.October 1999 A -13 . ...........................1 Hardware.........October 1999 ..................2 Software............. OUTPUT FORMAT FOR HOST COMPUTER (OPTION)..............B-1 1.....................................B-3 Sysmex KX-21N Operator’s Manual -.............B-1 1......................TECHNICAL INFORMATION APPENDIX B: TECHNICAL INFORMATION 1.............................. Level +3V or higher -3V or lower Data signal Logic "1". Start bit Logic "0". following optional part should be ordered in prior to the installation so that Sysmex service representative could install at once. Stop bit Control signal ON OFF Table B-1-2: Signal Level Sysmex KX-21N Operator’s Manual -. 1 2 3 4 5 6 7 8 9 Signal Name Receive data Transmit Data Data Terminal Ready Signal Ground Data Set Ready Request to Send Clear to Send (R×D) (T×D) (DTR) (SG) (DSR) (RTS) (CTS) Signal Direction From Host to KX-21N To Host from KX-21N To Host from KX-21N From Host to KX-21N To Host from KX-21N From Host to KX-21N 2. Signal Level Signal level conforms to JIS C6361.October 1999 B-1 . is used for host computer output of the KX-21N. 973-4531-1 OUTPUT UNIT NO. NOTE: • When the optional serial interface function is intended to incorporate to this instrument. OUTPUT FORMAT FOR HOST COMPUTER (OPTION) The bit serial voltage type. which conforms to the RS-232C interface.TECHNICAL INFORMATION 1. • Fixing screws for this connector are in inch-specification. 1 KX-21N 1 . Communication Format The data is communicated in the asynchronous. full duplex mode. Table B-1-1: Pin Assignment 3. female connector. • Use a 9-pin D-SUB. 4. The serial interface port for the connection with the host computer is on the rear panel of the main unit. Connector Signals Pin No. 1 Hardware 1. when an option is incorporated. Connector • The connector for the output to the host computer is located on the rear panel. October 1999 .TECHNICAL INFORMATION 5.4 kΩ Vss MC145407 Receiver EMI filter Figure B-1-2: Interface Input Circuit B-2 Sysmex KX-21N Operator’s Manual -. Interface Circuit • Output circuit VDD 300 Ω Vss MC145407 Driver OUT EMI filter Figure B-1-1: Interface Output Circuit • Input circuit VDD 15 kΩ IN 5. • Class A One-way transmission to the host computer without requiring ACK nor NAK from host computer. Figure B-1-4: Data Transmission Sysmex KX-21N Operator’s Manual -. instruction is made whether the same data is sent again or the transmission is canceled by key input. (Except for K-DPS output) 2) 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. If the reply is still NAK after 3 retries.TECHNICAL INFORMATION 1 . • Class B The KX-21N transmits data and then waits for ACK or NAK to complete the data transmission. KX-21N Host computer Analysis data is sent. Analysis data is received. ACK (06H) is sent. Analysis data is sent automatically (retrying up to 3 times). ACK When an error does not occur. Analysis data transmission is completed correctly. NAK (15H) is sent. Communication error occurs. (Except for K-DPS output) Structure of text "STX" (02 H) is sent prior to data and "ETX" (03 H) is sent at the end of data.October 1999 B-3 . and can be selected according to the system status. 2 Software 1. 1) Communication Format Code ASCII codes are used for output. NAK When an error occurs. October 1999 . NOTE: The details of KX-21N and K-1000 format are as follows. • The setting of the connecting device is changed in the setting program. • The control signal DSR is off. sample ID No. • The computer is off line. They differ in length and content of the text.TECHNICAL INFORMATION 4) Transmission errors If the KX-21N detects a transmission error. • KX-21N format KX-21N format has two formats. However. (They are distinguished by the sample distinction code. the text is divided into 2 or more blocks. the data transmission is canceled and an error message is displayed. the fourth NAK is sent. Text Format The following three types of formats are used for computer output. one is "analysis data format" for output of the sample data..) 5) Timing. and the other is "QC data format" for output of the QC data. (Class B only) • After the data is transmitted. 18-parameter data. The ETB (17 H) is not used. The KX-21N resends the data automatically up to 3 times when NAK is sent. there is no response from the computer in 15 seconds. other than ACK or NAK is sent from the computer. and content of transmission Serial interface ↓ Host computer Analysis data (A) QC data (A) Normal analysis Quality control Table B-1-3: Content of Transmission • Analysis data includes the date. • 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 • KX-21N format is selected at the time of shipping from the factory. B-4 Sysmex KX-21N Operator’s Manual -. subject. The number in text distinction code II shows the order of the blocks. • After the data is transmitted.) The text distinction code II is fixed at "1". and the flag. Transmission errors occur in the following situations. (Class B only) • After the data is transmitted. when the text exceeds 256 bytes in a future modification. • QC data is X or L-J data. Re-transmission of the data ([1] key) or cancellation of the transmission ([3] key) can be selected. 2. (Class B only. of Characters 1 1 1 1 4 2 2 1 15 6 1 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 1 Total 131 Example (02 H) "D" "1" "U" "1999" "09" "30" (O) (OOOOOOOOOOOOOOO) (OOOOOO) "O" XXX. PDA information Reserve WBC RBC HGB HCT MCV MCH MCHC PLT LYM% (W-SCR) MXD% (W-MCR) NEUT% (W-LCR) LYM# (W-SCC) MXD# (W-MCC) NEUT# (W-LCC) RDW-SD RDW-CV PDW MPV P-LCR ETX [× 10 3/µ L] [× 10 6/µ L] [g/dL] [%] [fL] [pg] [g/dL] [× 10 3/µ L] [%] [%] [%] [× 10 3/µ L] [× 10 3/µ L] [× 10 3/µ L] [fL] [%] [fL] [fL] [%] Table B-1-4: Analysis Data Format Sysmex KX-21N Operator’s Manual -.XF XXX.October 1999 B-5 .XF XXX.XF (03 H) STX Text distinction code I Text distinction code ll Sample distinction code Year (Month or Day) Month (or Day) Day (or Year) Analysis information Sample ID No.XF XXX.XF XXX.XXF XXX.XF XXX.XF XXX.XF XXX.XF XXXXF XXX.XF XXX.XF XXX.XF XXX.XF XXX.TECHNICAL INFORMATION (1) Analysis data format Parameter No.XF XX.XF XXX.XF XXX.XF XXX. October 1999 .X (03 H) STX Text distinction code I Text distinction code II Sample distinction code Data distinction code Year (Month or Day) Month (or Day) Day (or Year) Hour Minute QC File Number Not used Reserve WBC LYM% (W-SCR) MXD% (W-MCR) NEUT% (W-LCR) LYM# (W-SCC) MXD# (W-MCC) NEUT# (W-LCC) RBC HGB HCT MCV MCH MCHC RDW.X XX.X XXX. of Characters 1 1 1 1 1 4 2 2 2 2 1 1 1 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 1 Total 105 Example (02 H) "D" "1" "C" "X" or "L" "1999" "09" "30" "09" "59" "5" "0" "0" XXX.XX XXX.X XXX.X XXX.CV PLT PDW MPV P-LCR W-SMV W-LMV ETX [× 10 3/µ L] [%] [%] [%] [× 10 3/µ L] [× 10 3/µ L] [× 10 3/µ L] [× 10 6/µ L] [g/dL] [%] [fL] [pg] [g/dL] [fL] [%] [× 10 3/µ L] [fL] [fL] [%] [fL] [fL] Table B-1-5: QC data format B-6 Sysmex KX-21N Operator’s Manual -.X XXX.X XXXX XXX.X XXX.X XXX.X XXX.X XXX.X XXX.X XXX.X XXX.X XXX.X XXX.X XXX.TECHNICAL INFORMATION (2) QC data format Parameter No.X XXX.SD RDW.X XXX. October 1999 B-7 . Item WBC histogram information WBC histogram flag RBC histogram information RBC histogram flag PLT histogram information PLT histogram flag No. Histogram is abnormal. the decimal point specified in each parameter has to be added and represented by numeric value at the host computer. Manual No.TECHNICAL INFORMATION (3) 1) 2) Details of the analysis data output in KX-21N format The order of output is from the top parameter to the bottom. The order of the date conforms to the format in the setting program in the setting program. of Characters 1 1 1 1 1 1 Table B-1-7: PDA Information Code "0" "1" "2 " Description Histogram is normal. The data is sent from the upper line without performing zero suppression. input "0" "5" 3) 4) WB mode analysis Pre-diluted mode analysis Table B-1-6: Analysis Information 5) PDA information consists of the following 6 items. Because the decimal point is not sent. Manually discriminated Table B-1-8: Histogram Information Sysmex KX-21N Operator’s Manual -. Analysis information shows the following content of the analysis. RBC/PLT (T1) discriminator cannot be determined. WBC (T1) or (T2) discriminator level is high. WBC Table B-1-9: Histogram Flag The histogram flag corresponds to the flagging characters of the LCD and the printer as follows. WBC/RBC/PLT Analysis is impossible because there is no pair of intersection on the 20% degree level for calculation of DW.TECHNICAL INFORMATION Code "0" "1" "2" "3" "4" "5" "6" "7" "8" "9" "A" Description Normal WBC/RBC/PLT (L) discriminator degree is high. WBC (T2) discriminator cannot be determined. WBC The particle count equal to or less than (L) discriminator exceeds the range. and the data is not reliable.October 1999 . Particle distribution FLAG “0” “1” “2” “3” “4” “5” “6” “7” “8” “9” "A" Flagging characters of LCD and printer WBC RBC PLT WL WU RL RU DW MP RL RU DW MP T1 T2 F1 F2 F3 AG Table B-1-10: Flagging Character B-8 Sysmex KX-21N Operator’s Manual -. and the data is not reliable. WBC/RBC/PLT (U) discriminator degree is high. WBC (T1) discriminator level is high. WBC (T2) discriminator level is high. and the data is not reliable. RBC/PLT Two peaks are recognized in the particle distribution. However. it is indicated as follows: *0003 In case of analysis error.) The text distinction code II is fixed at "1"." Out of linearity limit Reliability is low." Abnormality judgment is "-. They differ in length and content of the text. Upper digit Lower digit Data Flag Figure B-1-5: Numerical Data Configuration Code "0" "1" "2" "3" "4" Description Normal Abnormality judgment is "+. the text is divided into 2 or more blocks. Table B-1-11: Details of Flag 7) 8) If the data over-flows.October 1999 B-9 . Sysmex KX-21N Operator’s Manual -. the data is transmitted as follows: *0000 • K-1000 format K-1000 format has two formats.TECHNICAL INFORMATION 6) The numerical data configuration in the Analysis Data Format is as follows. The number in text distinction code II shows the order of the blocks. or if the data lacks some data such as the calculation parameter in pre-diluted mode. when the text exceeds 256 bytes in a future modification. The ETB (17 H) is not used. and the other is "QC data format" for output of the QC data. one is "analysis data format" for output of the sample data. (They are distinguished by the sample distinction code. XF XXX.October 1999 .XF XXX.XF XXX.XF (03 H) STX Text distinction code I Text distinction code ll Sample distinction code Year (Month or Day) Month (or Day) Day (or Year) Analysis information Sample ID No.XF XXX.XF XX.XF XXX.XF XXX.XF XXXXF XXX.XF XXX.XF XXX.TECHNICAL INFORMATION (1) Analysis data format Parameter No.XF XXX.XXF XXX.XF XXX.XF XXX. PDA information RDW select information WBC RBC HGB HCT MCV MCH MCHC PLT LYM% (W-SCR) MXD% (W-MCR) NEUT% (W-LCR) LYM# (W-SCC) MXD# (W-MCC) NEUT# (W-LCC) RDW-SD/CD PDW MPV P-LCR ETX [× 10 3/µ L] [× 10 6/µ L] [g/dL] [%] [fL] [pg] [g/dL] [× 10 3/µ L] [%] [%] [%] [× 10 3/µ L] [× 10 3/µ L] [× 10 3/µ L] [fL/%] [fL] [fL] [%] Table B-1-12: Analysis Data Format B-10 Sysmex KX-21N Operator’s Manual -. of Characters 1 1 1 1 2 2 2 1 12 6 1 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 1 Total 121 Example (02 H) "D" "1" "U" "99" "09" "30" (O) (OOOOOOOOOOOO) (OOOOOO) "S" or "C" XXX.XF XXX.XF XXX. X XXXX XXX.X XXX.TECHNICAL INFORMATION (2) QC data format Parameter No.X XXX.X XXX. of Characters 1 1 1 1 1 2 2 2 2 2 1 1 1 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 1 Total 99 Example (02 H) "D" "1" "C" "X" or "L" "97" "09" "30" "09" "59" "5" "0" "C" XXX.X XXX.XX XXX.X XXX.X XXX.X XXX.X XXX.X XXX.X XX.X XXX.X XXX.X (03 H) STX Text distinction code I Text distinction code II Sample distinction code Data distinction code Year (Month or Day) Month (or Day) Day (or Year) Hour Minute QC File Number Not used RDW select information WBC LYM% (W-SCR) MXD% (W-MCR) NEUT% (W-LCR) LYM# (W-SCC) MXD# (W-MCC) NEUT# (W-LCC) RBC HGB HCT MCV MCH MCHC RDW-(CV/SD) PLT PDW MPV P-LCR W-SMV W-LMV ETX [× 10 3/µ L] [%] [%] [%] [× 10 3/µ L] [× 10 3/µ L] [× 10 3/µ L] [× 10 6/µ L] [g/dL] [%] [fL] [pg] [g/dL] [%/fL] [× 10 3/µ L] [fL] [fL] [%] [fL] [fL] Table B-1-13: QC data format Sysmex KX-21N Operator’s Manual -.October 1999 B-11 .X XXX.X XXX.X XXX.X XXX. input "0" "5" 3) 4) WB mode analysis Pre-diluted mode analysis Table B-1-14 Analysis Information 5) The sample ID No. Item WBC histogram information WBC histogram flag RBC histogram information RBC histogram flag PLT histogram information PLT histogram flag No. Manual No. In this case. Histogram is abnormal. but 12 digits are output in this format. "-" (2D H) may be inserted in the numeral column. The data is sent from the upper line without performing zero suppression. Depending on the usage. The order of the date conforms to the format in the setting program in the setting program. of Characters 1 1 1 1 1 1 6) Table B-1-15: PDA Information Code "0" "1" "2 " Description Histogram is normal. Because the decimal point is not sent.October 1999 . is 15-digit numerals. the decimal point specified in each parameter has to be added and represented by numeric value at the host computer. PDA information consists of the following 6 items. "-" is included in the 12 digits. Analysis information shows the following content of the analysis.TECHNICAL INFORMATION (3) 1) 2) Details of the analysis data output in K-1000 format The order of output is from the top parameter to the bottom. Manually discriminated Table B-1-16: Histogram Information B-12 Sysmex KX-21N Operator’s Manual -. The upper 3 digits are deleted. WBC (T1) or (T2) discriminator level is high.October 1999 B-13 . RBC/PLT Two peaks are recognized in the particle distribution. RBC/PLT (T1) discriminator cannot be determined. WBC Table B-1-17: Histogram Flag The histogram flag corresponds to the flagging characters of the LCD and the printer as follows. and the data is not reliable. Particle distribution FLAG “0” “1” “2” “3” “4” “5” “6” “7” “8” “9” "A" Flagging characters of LCD and printer WBC RBC PLT WL WU RL RU DW MP RL RU DW MP T1 T2 F1 F2 F3 AG Table B-1-18: Flagging Character Sysmex KX-21N Operator’s Manual -. WBC (T2) discriminator level is high. WBC/RBC/PLT Analysis is impossible because there is no pair of intersection on the 20% degree level for calculation of DW. and the data is not reliable.TECHNICAL INFORMATION Code "0" "1" "2" "3" "4" "5" "6" "7" "8" "9" "A" Description Normal WBC/RBC/PLT (L) discriminator degree is high. WBC (T1) discriminator level is high. WBC/RBC/PLT (U) discriminator degree is high. and the data is not reliable. WBC The particle count equal to or less than (L) discriminator exceeds the range. WBC (T2) discriminator cannot be determined. Table B-1-19: Details of Flag 9) 10) If the data over-flows. "C": RDW-CV "S": RDW-SD NOTE: • RDW-SD is selected at the initial setting of K-1000. 8) The numerical data configuration in the Analysis Data Format is as follows." Out of linearity limit Reliability is low. or if the data lacks some data such as the calculation parameter in pre-diluted mode. Section 6: HOST SETTINGS. Upper digit Lower digit Data Flag Figure B-1-6: Numerical Data Configuration Code "0" "1" "2" "3" "4" Description Normal Abnormality judgment is "+. it is indicated as follows: *0003 In case of analysis error. refer to Chapter 10.TECHNICAL INFORMATION 7) RDW select information It shows whether RDW-CV or RDW-SD is output.October 1999 ." Abnormality judgment is "-. • To output RDW-CV. the data is transmitted as follows: *0000 B-14 Sysmex KX-21N Operator’s Manual -. INDEX A Adjusting Pressure to 0.5-19 Execute QC Program --------------------------5-5 Executing and Quitting Stored Data Processing Program------------------.9-11 Analysis of RBC/PLT Histogram ----------.2-28 Chamber Errors -----------------------------.9-31 Front Panel ----------------------------------.4-26 Clean Sample Rotor Valve (SRV) ---------.1-12 Erase All ----------------------------------------5-7 Error History Print -------------------------.A-8 Sysmex KX-21N Operator’s Manual -.3-11.7-10 Check before Installation--------------------.3-21.2-30 External Device Errors ---------------------.4-16 Execute X Control--------------------------.5 kg/cm2 -------------8-5 Adjusting Vacuum to 250 mmHg------------8-6 Adjustment of Pressure and Vacuum --------8-2 Alarm Sounds -------------------------------.A-2 Check Trap Chamber Level and Discard ----4-6 Clean Rinse Cup-----------------------------.A-6 Connect Waste Line--------------------------.4-24 Automatic Calibration -------------------------6-3 Automatic Calibration Procedure-------------6-4 Automatic Stop Function of Pneumatic Unit1-4 B Blood Cell Discrimination Circuit ---------. 3-2 DP Output Settings--------------------------10-23 E Electric System------------------------------.6-3 Execution of Shutdown --------------------.1-13 Correcting a Sample Number--------------.5-27 Deletion (Stored Data)----------------------.10-8 DC Detection Method -------------------------9-2 Deletion--------------------------------------.A-6 Connect Host Computer---------------------A-12 Connect Handy Barcode Reader------------A-12 Connect Power Cord-------------------------A-12 Connect Printer-------------------------------A-12 Connect STROMATOLYSER-WH ---------.7-33 External Output ----------------.7-36 Every 3-Month Maintenance and Procedure ----------------------------.4-16 Clean SRV Tray--------------------------------4-7 Clean TD Chamber and Diluted Sample Line (Shutdown) ------------------------4-4 Clean Transducer (Rinse Sequence)-------.9-28 Emergency Stop Procedure----------------.5-31 F Factory Setting ------------------------------10-38 Front Interior--------------------------------.4-41 Connect Cables-------------------------------A-12 Connect CELLPACK ------------------------.4-24 Auto Rinse-----------------------------------.3-23 D Daily Maintenance and Procedure -----------4-4 Date/Time Settings --------------------------.9-30 Functional List of Error Messages------------7-5 G GP/LP Output Settings----------------------10-25 Graphic Screen---------------------------------1-8 Grounding-----------------------------------.October 1999 Connect Tube --------------------------------.3-14 Executing Automatic Calibration Program.2-32 Exit from QC Control Program------------.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------------------------------.9-11 Analysis Parameters----------------------------1-5 Analysis Procedure Flow Chart --------------2-2 As-Needed Maintenance and Procedure--.2-24 Display of Analysis Result ------------.1-14 i .6-13 CBC Analysis-----------------------------------9-5 Cell Count Parameters ----------------------.3-20 Detection Principle-----------------------------9-2 Display and Printing of Analysis Result --.9-20 Analysis of WBC Histogram ---------------.4-12 Clean Waste Chamber (Rinse Sequence)-----4-9 Clean WBC/RBC Transducer Aperture ----.A-9 Contents of Display----------------------------1-8 Connects of Package------------------------.4-28 Confirmation of Cycle Number -----------.9-10 C Calculating Calibration Value-----------------6-9 Calculation of RBC Constant -----------------9-9 Calibration Execution Timing ----------------6-1 Calibration Flow Chart ------------------------6-2 Calibration History Print -------------------.5-26 Expected Results ----------------------------.2-24.7-17 Analysis of Histogram----------------------.5-10 Execute L-J Control ------------------------. B-1 Host Settings---------------------------------10-17 I ID Reader Settings --------------------------10-30 Inspection before Turning ON the Power ---2-3 Installation and Relocation-----------------.7-27 Manual Calibration ----------------------------6-9 Manual Calibration Procedure-------------.7-13 N Names and Functions of Instruments -----.4-37 Replace Waste Tank-------------------------.2-28 Location of Control Knobs -------------------8-2 M Maintenance Errors-------------------------.9-33 Levy-Jennings Control (L-J)------------------5-1 Limitation of Hemoglobin -----------------.B-3 Start-up Procedure-----------------------------2-3 Status Display -------------------------------.4-41 Option Units------------------------------------1-3 Others ----------------------------------------.10-3 Sysmex KX-21N Operator’s Manual -.1-12 Left Side Interior----------------------------.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 R RBC Discriminator--------------------------.3-14 Program Version----------------------------.9-10 Pre-Diluted (PD) Mode---------------------.1-20 Monthly Maintenance and Procedure--------4-9 Motor Errors --------------------------------.2-31 Stored Data Screen--------------------------.2-32 Software---------------------------------------.October 1999 ii .4-33 System Setup --------------------------------. A-3 Instrument Specifications ------------------.6-10 Manual Discrimination ------------------------3-7 Measuring Unit Hydraulic System Block Diagram --------------------------9-4 Memory Errors------------------------------.7-23 Menu Tree-----------------------------------.1-17 IP Output Settings---------------------------10-27 K KX-21N Maintenance Checklist--------------4-2 L LCD Brightness Adjustment ---------------.9-10 RBC/PLT Analysis Flow -----------------------9-7 Rear Panel -----------------------------------.2-16 Prepare Reagent------------------------------.A-4 Replace Fuse---------------------------------.4-33 Reset SRV Cycle Counter ------------------.1-15.1-14.7-25 Outline of Operation---------------------------1-4 Output Format for Host Computer (Option) B-1 Output of Analysis Result to Host Computer -----------------------------.9-35 Reference Values-------------------------------6-1 Reinstalling the Program --------------------A-13 Remove Shipping Clamps-------------------.7-34 Status Display Messages ----------------------1-9 Stopping the Pneumatic Unit --------------.9-30 Non-Cyanide Hemoglobin Analysis Method ----------------------------------9-2 O Operation Procedure------------------------.4-22 Right Side Panel-----------------------------.H Hardware--------------------------------------.4-32 Replenish Reagent --------------------------.9-34 Left Side Panel ------------------------------.4-40 Supplies Replacement ----------------------.A-6 Pressure and Vacuum Display ---------------8-3 Pressure/Vacuum Errors-----------------------7-7 Print Set Values -----------------------------10-35 Printer Errors -------------------------------.4-36 Replace Printer Paper-----------------------.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 --------------------------.2-29 Limitations-----------------------------------. 1-16 Installation Space ---------------------.9-32 S Samples Used for Calibration-----------------6-1 Select QC File ----------------------------------5-6 Set Printer Paper (Option)-------------------A-10 Set TARGET/LIMIT Values ------------------5-8 Shutdown Procedure------------------------.2-27 Output to Host Computer ------------------.1-14 Installation Environment ------------.5-31 Procedures in each Analysis Mode-----------2-9 Processing Latest Samples---------------------3-2 Processing Stored Data ---------------------.3-15 Supplies List---------------------------------.2-25 Printing to Printer---------------------------.7-30 Printer Settings ------------------------------10-22 Printing of Analysis Result-----------------. 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 -.7-15 Troubleshooting Guide------------------------7-7 Turn Power ON ------------------------------A-13 Turning ON the Power and Self-Check------2-5 W WBC Discriminator -------------------------.T Temperature Errors-------------------------.October 1999 iii .7-16 Transducer Errors---------------------------.