Sysmex SF-3000 Instruction manual

OPERATOR’S MANUAL
AUTOMATED HEMATOLOGY ANALYZER
SF-3000
SYSMEX CORPORATION
KOBE, JAPAN
Copyright © 1995 - 2001 by SYSMEX CORPORATION
All rights reserved. No part of this Operator’s Manual may be Code No. 461-2459-3 reproduced in any form or by any means whatsoever without PRINTED IN JAPAN prior written permission of SYSMEX CORPORATION. Date of Last Revision: March 2001
SF-3000/06.95
Sysmex is a registered trademark of SYSMEX CORPORATION. CELLPACK, CELLCLEAN, STROMATOLYSER, SULFOLYSER, SF CHECK are trademarks of SYSMEX CORPORATION.
Canon is a registered trademark of Canon, Inc. Cubitainer is a registered trademark of Hedwin Corporation. DeskJet and LaserJet are registered trademarks of Hewlett-Packard Corporation. EPSON is a registered trademark of Seiko Epson Corporation. SMI and SMI Micro/Pettor are registered trademarks of Scientific Manufacturing Industries, Inc. Teflon is a registered trademark of E.I. du Pont de Nemours & Co., Inc. VENOJECT is a registered trademark of Terumo Corporation. OKI and MICROLINE are registered trademarks of Oki Electric Industry Co., Ltd.
Other trademarks referenced are property of their respective owners.
Patient names and doctor names are entered for information and illustration purposes only, and do not imply real specific persons.
Revised September 1998
RECEIVING INSTRUCTIONS
The SF-3000 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 SF-3000 system and its components have arrived.
Wait for your service representative to unpack the system and open the packages.
Follow the unpacking and storage instructions provided on the outside of the package. Special requirements such as refrigeration are clearly marked on the outside of the carton and will be included in the unpacking instructions and package inserts.
WARRANTY INFORMATION
All instruments manufactured by Sysmex® are warranted against defective materials or workmanship for a period of one year commencing on the installation date at the customer's required location.
This Warranty does not cover any defect, malfunction, or damage due to:
1. Accident, neglect or willful mistreatment of the product
2. Failure to use, operate, service, or maintain the product in accordance with the applicable Sysmex Operator's Manual
3. Failure to use the appropriate reagents or chemicals specified for the product
Sysmex SF-3000 Operator's Manual -- Revised September 1995
SF-3000 OPERATOR'S MANUAL
TABLE OF CONTENTS
CHAPTER 1: INTRODUCTION
1. INTRODUCTION.................................................................................... 1-1
2. OPERATOR'S MANUAL ORGANIZATION........................................ 1-2
3. INFORMATIONAL HEADINGS ........................................................... 1-3
3.1 NOTE, CAUTION and WARNING ...................................... 1-3
3.2 Document Conventions .......................................................... 1-3
4. SYSTEM OVERVIEW............................................................................ 1-4
5. SYSTEM OPTIONS ................................................................................ 1-5
6. SAFETY................................................................................................... 1-6
6.1 General Safety ........................................................................ 1-6
6.2 Hazardous and Biohazardous Material................................... 1-6
6.3 Reagent Safety........................................................................ 1-6
6.4 Laser Safety............................................................................ 1-7
7. OPERATIONAL SUMMARY ................................................................ 1-8
8. ANALYSIS PARAMETERS................................................................... 1-9
9. DISPLAY SCREEN............................................................................... 1-10
9.1 LCD (Liquid Crystal Display) Screen.................................. 1-10
9.2 Root Menus .......................................................................... 1-14
9.3 Hard Copy ............................................................................ 1-16
10. PASSWORD .......................................................................................... 1-17
11. EMERGENCY SHUTDOWN PROCEDURE ...................................... 1-18
12. ALARMS ............................................................................................... 1-18
13. INSTALLATION REQUIREMENTS................................................... 1-19
13.1 Relocation Information......................................................... 1-19
13.2 Electrical Requirements ....................................................... 1-19
13.3 Space Requirements ............................................................. 1-20
13.4 Installation Environment ...................................................... 1-20
14. SYSTEM SPECIFICATIONS ............................................................... 1-21
CHAPTER 2: SAMPLE PROCESSING
1. INTRODUCTION.................................................................................... 2-1
1.1 Summary of Operation Mode ................................................ 2-1
1.2 Operational Procedures in Each Mode .................................. 2-2
2. START-UP PROCEDURE...................................................................... 2-3
2.1 Operator Checks .................................................................... 2-3
2.2 Turning On the Power ........................................................... 2-4
2.3 Self-Checks............................................................................ 2-4
2.4 Pressure Gauge Check ........................................................... 2-6
2.5 Auto Output Settings Check .................................................. 2-6
3. QUALITY CONTROL ANALYSIS........................................................ 2-7
3.1 QC Analysis : Manual Mode ................................................. 2-7
3.2 QC Analysis : Auto Mode ................................................... 2-12
3.3 QC Analysis : Manual Closed Mode................................... 2-13
3.4 QC Analysis : Manual CP Mode ......................................... 2-17
(To be continued)
Sysmex SF-3000 Operator's Manual -- Revised December 1995 i
4. ANALYSIS MODE PROCEDURES....................................................2-18
4.1 Manual Mode ......................................................................2-18
4.2 Capillary Mode.................................................................... 2-23
4.3 Auto Mode...........................................................................2-29
4.4 Manual Closed Mode..........................................................2-37
4.5 Manual CP Mode.................................................................2-43
5. SHUTDOWN......................................................................................... 2-49
5.1 Shutdown Procedure............................................................2-49
6. TIMER MODE ......................................................................................2-51
6.1 Restarting the Pneumatic Unit.............................................2-51
CHAPTER 3: WORK LIST
1. INTRODUCTION ...................................................................................3-1
1.1 Order Inquiry Method........................................................... 3-1
2. EXECUTING A WORK LIST PROGRAM ...........................................3-2
2.1 Work List Display.................................................................3-2
2.2 Data Entry............................................................................. 3-3
3. DOWNLOAD LIST.................................................................................3-6
3.1 From Host Computer (HC)................................................... 3-6
3.2 From Floppy Disk (FD)........................................................3-8
4. DELETE.................................................................................................3-10
4.1 All Data...............................................................................3-10
4.2 Marked Data........................................................................3-11
4.3 Current Data........................................................................3-12
5. GP OUTPUT..........................................................................................3-13
6. BACKUP............................................................................................... 3-14
CHAPTER 4: RESULT INTERPRETATION/REPORTS
1. INTRODUCTION ................................................................................... 4-1
2. INTERPRETIVE (IP) MESSAGES........................................................4-2
3. LIST DISPLAY/STORED DATA...........................................................4-8
3.1 Sample Information Screen (Page 1)...................................4-10
3.2 CBC8 Screen (Page 2).........................................................4-13
3.3 WBC+5Diff# Screen (Page 3).............................................4-14
3.4 WBC+5Diff% Screen (Page 4)...........................................4-15
3.5 RBC/PLT Screen (Page 5) .................................................. 4-16
3.6 IP Messages Screen (Page 6)...............................................4-18
4. GRAPHIC DISPLAY............................................................................ 4-20
5. DATA VALIDATION...........................................................................4-24
6. MARK DATA........................................................................................4-25
7. SELECT DISPLAY...............................................................................4-26
7.1 Select By Flagging..............................................................4-27
7.2 Select By Date.....................................................................4-29
7.3 Select By No Output............................................................4-31
7.4 QC Data...............................................................................4-33
7.5 All Samples.........................................................................4-34
7.6 Read FD...............................................................................4-35
(To be continued)
ii Sysmex SF-3000 Operator's Manual -- Revised September 1995
Sysmex SF-3000 Operator's Manual -- Revised July 1996
8. SEARCH STORED DATA.................................................................... 4-38
7.1 Top/Bottom.......................................................................... 4-38
7.2 By Sample No...................................................................... 4-39
7.3 Same Day............................................................................. 4-40
7.4 By Date ................................................................................ 4-41
9. SORT STORED DATA ......................................................................... 4-43
9.1 Sequence Order.................................................................... 4-43
9.2 Sample No. Order ................................................................ 4-45
10. EDIT SAMPLE INFORMATION ......................................................... 4-46
10.1 Sample No. .......................................................................... 4-47
10.2 ID Read Status ..................................................................... 4-48
10.3 POS to NEG......................................................................... 4-48
11. OUTPUT STORED DATA.................................................................... 4-49
11.1 Current Data......................................................................... 4-51
11.2 Marked Data ........................................................................ 4-52
11.3 All Data................................................................................ 4-52
11.4 Cancel .................................................................................. 4-53
11.5 Backup (FD) ........................................................................ 4-54
12. DELETE................................................................................................. 4-58
12.1 Current Data......................................................................... 4-59
12.2 Marked Data ........................................................................ 4-60
12.3 All Data................................................................................ 4-61
13. AUTO OUTPUT .................................................................................... 4-62
CHAPTER 5: MAINTENANCE AND SUPPLIES
1. INTRODUCTION .................................................................................... 5-1
2. SF-3000 MAINTENANCE CHECK LIST .............................................. 5-3
3. DAILY MAINTENANCE........................................................................ 5-4
3.1 Clean Detector Chamber and Manometer (Shutdown) ......... 5-4
3.2 Remove Fluid from Pneumatic Unit Trap Chamber.............. 5-6
4. WEEKLY MAINTENANCE ................................................................... 5-7
4.1 Clean SRV Tray..................................................................... 5-7
4.2 Execute Clean WBC Detector Sequence............................... 5-9
5. MONTHLY MAINTENANCE.............................................................. 5-14
5.1 Clean Orifice........................................................................ 5-14
5.2 Execute Clean Waste Chamber Sequence ........................... 5-16
5.3 Clean Sample Rotor Valve (SRV)....................................... 5-21
6. YEARLY MAINTENANCE.................................................................. 5-26
6.1 Visual Inspection for Laser Safety ...................................... 5-26
7. AS NEEDED MAINTENANCE............................................................ 5-29
7.1 Clean Manual Rinse Mechanism......................................... 5-29
7.2 Execute RBC Aperture Clog Removal Sequence................ 5-31
7.3 Execute Clean RBC Transducer Sequence.......................... 5-33
7.4 Clean RBC Detector Aperture............................................. 5-38
7.5 Execute Remove Flow Cell Air Bubbles Sequence ............ 5-41
7.6 Execute Replace Sheath Flow Reagent Sequence............... 5-43
7.7 Replace Waste Container (if used) ...................................... 5-45
(To be continued)
Sysmex SF-3000 Operator's Manual -- Revised September 1995 iii
8. REPLACEMENTS................................................................................. 5-46
8.1 Replace Reagent .................................................................. 5-46
8.2 Replace the Piercer (Auto Sampler Unit) ............................ 5-51
8.3 Replace the Piercer (Manual CP Unit) ................................ 5-58
8.4 Replace the Hand Clipper.................................................... 5-62
8.5 Replace the Rubber Plate No. 39......................................... 5-63
8.6 Replace the Anti-Shock Rubber No. 49 .............................. 5-64
8.7 Replace the Fuses ................................................................ 5-65
8.8 Replace the Belt No. 6......................................................... 5-67
9. RESET THE COUNTER ....................................................................... 5-69
10. FORMAT FD.......................................................................................... 5-72
11. SUPPLIES AND REPLACEMENT PARTS LISTING......................... 5-74
CHAPTER 6: QUALITY CONTROL
1. INTRODUCTION.................................................................................... 6-1
1.1 Types of QC Method............................................................. 6-2
1.2 QC Parameters To Be Monitored.......................................... 6-2
2. DELETE FILE ......................................................................................... 6-3
3. SYSTEM SETTINGS .............................................................................. 6-5
4. QC PARAMETER SELECTION ............................................................ 6-7
4.1 Selecting QC Parameter ( X /L-J Control) ........................... 6-7
4.2 Selecting QC Parameter ( X M Control) .............................. 6-8
5. SETTING X M CONTROL ................................................................. 6-10
5.1 Executing the X M Control Settings Program ................... 6-10
6. TARGET/LIMIT.................................................................................... 6-13
6.1 Display................................................................................. 6-13
6.2 Read FD (Floppy Disk) ....................................................... 6-15
6.3 Help ..................................................................................... 6-19
6.4 Auto Setting......................................................................... 6-21
6.5 Manual Change.................................................................... 6-25
6.6 Lot Information ................................................................... 6-28
7. QC CHART............................................................................................ 6-31
7.1 Select File............................................................................ 6-33
7.2 Output QC Chart/Data......................................................... 6-34
7.3 Mean/SD (Calculation)........................................................ 6-36
7.4 Delete Plot ........................................................................... 6-38
7.5 Cal. History ......................................................................... 6-40
8. MANUAL QC ANALYSIS ................................................................... 6-41
9. SAMPLER QC ANALYSIS (L-J) ......................................................... 6-44
10. QC METHODS AND APPLICATIONS............................................... 6-47
10.1 X Control .......................................................................... 6-47
10.2 L-J Control .......................................................................... 6-47
10.3 X M Control....................................................................... 6-48
11. VARIABLE TARGET FUNCTION...................................................... 6-51
11.1 How Target Values Are Calculated..................................... 6-51
11.2 Variable Target Function and Erroneous Data.................... 6-52
12. CONTROL CHART DEFINITION....................................................... 6-53
iv Sysmex SF-3000 Operator's Manual -- Revised September 1995
CHAPTER 7: CALIBRATION
1. INTRODUCTION.................................................................................... 7-1
1.1 Calibration Implementation Standards .................................. 7-1
1.2 Calibration Samples............................................................... 7-2
1.3 Reference Values................................................................... 7-2
2. HGB/HCT AUTO .................................................................................... 7-3
2.1 Overview of the HGB/HCT Auto Program........................... 7-3
2.2 Setting (Entering Reference Values) ..................................... 7-6
2.3 Analyze (Analyzing).............................................................. 7-8
2.4 Exclude (Excluding and Recovering Data) ......................... 7-10
2.5 Exe. Cal. (Calibrating)......................................................... 7-12
2.6 Graphic (Displaying Graphs)............................................... 7-14
3. HGB/HCT MANUAL............................................................................ 7-15
3.1 Calculating the Compensation Factor.................................. 7-15
3.2 Executing the HGB/HCT Manual Program......................... 7-16
4. CALIBRATION HISTORY................................................................... 7-18
4.1 Displaying the Cal. History ................................................. 7-18
4.2 Deleting the Cal. History ..................................................... 7-19
4.3 Outputting the Cal. History.................................................. 7-20
CHAPTER 8: TROUBLESHOOTING
1. INTRODUCTION.................................................................................... 8-1
2. TROUBLESHOOTING BY ERROR MESSAGES ................................ 8-2
2.1 Alphabetical Error Message Index ........................................ 8-2
2.2 Contents (Error Messages By Function)................................ 8-5
2.3 Troubleshooting Guide .......................................................... 8-9
3. TEST PROGRAMS ............................................................................... 8-59
3.1 Executing a Test Program.................................................... 8-59
3.2 Test SRV.............................................................................. 8-62
3.3 Test Motor ........................................................................... 8-63
3.4 Test PDA PCB..................................................................... 8-69
3.5 Test Laser Unit .................................................................... 8-70
3.6 Test Sampler ........................................................................ 8-71
3.7 Test Bar Code Reader.......................................................... 8-74
3.8 Test Memory........................................................................ 8-75
3.9 Test Floppy Disk.................................................................. 8-76
3.10 Test LCD Display................................................................ 8-78
3.11 Test Touch Panel ................................................................. 8-79
3.12 Test Output .......................................................................... 8-80
3.13 Version Check ..................................................................... 8-83
3.14 Service Data......................................................................... 8-85
4. STATUS DISPLAY............................................................................... 8-90
5. ERROR LOG ......................................................................................... 8-94
Sysmex SF-3000 Operator's Manual -- Revised September 1995 v
CHAPTER 9: ADJUSTMENT
1. INTRODUCTION.................................................................................... 9-1
2. PRESSURE/VACUUM DISPLAY ......................................................... 9-1
2.1 Pneumatic Gauges .................................................................. 9-1
2.2 Displaying the Monitored Values on the LCD....................... 9-2
3. PNEUMATIC UNIT ADJUSTMENT..................................................... 9-3
3.1 Adjusting the 2.0 kg/cm
2
........................................................ 9-4
3.2 Adjusting the Vacuum............................................................ 9-5
4. MAIN UNIT ADJUSTMENT.................................................................. 9-5
4.1 Adjusting to 0.6 kg/cm
4.2 Adjusting to 0.5 kg/cm
2
......................................................... 9-6
2
......................................................... 9-7
4.3 Adjusting the 250 mmHg Vacuum......................................... 9-8
5. LCD CONTRAST ADJUSTMENT......................................................... 9-9
6. ID BAR CODE READER ADJUSTMENT (Option)............................ 9-10
CHAPTER 10: FUNCTIONAL DESCRIPTION
1. INTRODUCTION.................................................................................. 10-1
2. DETECTION PRINCIPLES .................................................................. 10-2
2.1 Flow Cytometry by Semiconductor Laser........................... 10-2
2.2 DC Detection Method.......................................................... 10-3
2.3 SLS-Hemoglobin ................................................................. 10-3
3. SAMPLE FLOW BLOCK DIAGRAM ................................................. 10-4
4. RBC/PLT/HGB ANALYSIS ................................................................. 10-5
4.1 RBC/PLT Analysis Flow..................................................... 10-5
4.2 HGB Analysis Flow............................................................. 10-6
4.3 Red Blood Cell (RBC) Indices ............................................ 10-7
5. WBC CLASSIFICATION ..................................................................... 10-8
5.1 4DIFF Analysis.................................................................... 10-8
5.2 WBC/BASO Analysis ......................................................... 10-9
6. WBC SCATTERGRAMS.................................................................... 10-10
7. RBC/PLT PARTICLE SIZE DISTRIBUTION ANALYSIS .............. 10-12
7.1 RBC Particle Size Distribution.......................................... 10-12
7.2 PLT Particle Size Distribution........................................... 10-13
7.3 Particle Size Distribution Representation.......................... 10-14
7.4 Histogram Flags................................................................. 10-15
8. MAIN UNIT ELECTRONIC SYSTEM .............................................. 10-16
9. MAIN UNIT COMPONENTS............................................................. 10-18
9.1 Front................................................................................... 10-18
9.2 Rear.................................................................................... 10-20
9.3 Right Side .......................................................................... 10-22
9.4 Left Side............................................................................. 10-24
9.5 Front Interior...................................................................... 10-25
9.6 Left Interior........................................................................ 10-26
9.7 Right Interior ..................................................................... 10-30
(To be continued)
vi Sysmex SF-3000 Operator's Manual -- Revised September 1995
10. PNEUMATIC UNIT COMPONENTS................................................ 10-32
10.1 Front................................................................................... 10-32
10.2 Right Side .......................................................................... 10-33
10.3 Top Interior........................................................................ 10-34
10.4 Right Interior ..................................................................... 10-34
11. CAP PIERCING SAMPLER UNIT (OPTION) .................................. 10-35
11.1 Top..................................................................................... 10-35
11.2 Top Interior........................................................................ 10-36
12. MANUAL CP UNIT (OPTION).......................................................... 10-37
13. REAGENT SYSTEM........................................................................... 10-38
CHAPTER 11: SYSTEM SETUP
1. INTRODUCTION.................................................................................. 11-1
2. AUTO MANAGEMENT PROGRAMS................................................ 11-3
2.1 Auto Output Condition ........................................................ 11-6
2.2 Auto Output Mode (Data Specification).............................. 11-8
2.3 Auto Erase ........................................................................... 11-9
2.4 Auto Validation ................................................................. 11-11
3. DATA CRITERIA ............................................................................... 11-13
3.1 Mark Limits ....................................................................... 11-16
3.2 Critical Limits.................................................................... 11-18
3.3 Sampler Stop Limits .......................................................... 11-20
3.4 Sampler Stop Condition..................................................... 11-22
4. FLAG SYSTEM................................................................................... 11-24
4.1 WBC .................................................................................. 11-27
4.2 RBC ................................................................................... 11-29
4.3 PLT .................................................................................... 11-30
5. PERIPHERAL CONFIGURATION.................................................... 11-32
5.1 HC Setting (Host Computer) ............................................. 11-35
5.2 GP Setting (Graphic Printer) ............................................. 11-37
5.3 DP Setting (Data Printer)................................................... 11-38
6. GENERAL SET UP ............................................................................. 11-41
6.1 Date/Time .......................................................................... 11-44
6.2 Units................................................................................... 11-45
6.3 Password............................................................................ 11-47
6.4 Timer Mode ....................................................................... 11-48
6.5 Normal Range Display ...................................................... 11-49
6.6 Date Format ....................................................................... 11-51
6.7 ID Reader........................................................................... 11-52
6.8 Blood Sensor...................................................................... 11-54
6.9 Work List........................................................................... 11-56
7. OUTPUT SET VALUES ..................................................................... 11-57
7.1 Output to GP....................................................................... 11-57
7.2 Backup to FD...................................................................... 11-57
Sysmex SF-3000 Operator's Manual -- Revised March 1996 vii
APPENDIX A: MENU TREE
APPENDIX B: INSTALLATION
1. PREINSTALLATION............................................................................. B-2
1.1 Unpacking Check List .......................................................... B-2
1.2 Supplementary Parts Information......................................... B-5
2. LAYOUT AND WORK SPACE ............................................................ B-6
3. REMOVING PACKING MATERIAL................................................... B-7
3.1 Front Cover........................................................................... B-7
3.2 Front Panel............................................................................ B-7
3.3 Main Unit Chassis................................................................. B-9
3.4 SRV..................................................................................... B-10
3.5 Rear Panel........................................................................... B-10
3.6 Pneumatic Unit ................................................................... B-11
4. TRAY .................................................................................................... B-11
5. BAR CODE ID READER (Optional)................................................... B-12
6. CP SAMPLER UNIT (Optional) .......................................................... B-13
6.1 Main Unit............................................................................ B-13
6.2 Sampler Unit....................................................................... B-14
6.3 Connection to Main Unit .................................................... B-15
7. MANUAL CP UNIT (Optional) ........................................................... B-17
7.1 Main Unit............................................................................ B-17
7.2 Manual CP Unit .................................................................. B-18
7.3 Connection to Main Unit .................................................... B-18
8. TUBE CONNECTION.......................................................................... B-22
8.1 Vacuum Line ...................................................................... B-22
8.2 Pressure Line ...................................................................... B-22
8.3 Reagent Container Preparation........................................... B-23
8.4 Reagent Lines ..................................................................... B-26
8.5 Waste Container.................................................................. B-27
9. BATTERY BACKUP ........................................................................... B-28
10. CABLE AND POWER CORD CONNECTIONS................................ B-29
10.1 Output Connections ............................................................ B-29
10.2 Pneumatic Cable Connections ............................................ B-30
10.3 Power Cord Connections .................................................... B-30
11. POWER ON AND SYSTEM SETUP................................................... B-31
11.1 Power On ............................................................................ B-31
11.2 System Setup ...................................................................... B-31
11.3 System Check ..................................................................... B-32
viii Sysmex SF-3000 Operator's Manual -- Revised December 1995
APPENDIX C: TECHNICAL INFORMATION
1. SERIAL INTERFACE FOR HOST COMPUTER................................. C-2
1.1 Connection............................................................................ C-2
1.2 Input/Output Signals............................................................. C-2
1.3 Communication Format........................................................ C-2
1.4 Baud Rate/Character Structure ............................................. C-2
1.5 Signal Level.......................................................................... C-3
1.6 Interface Circuit.................................................................... C-3
1.7 Software................................................................................ C-4
2. TEXT FORMAT ..................................................................................... C-8
2.1 Sample Data Format ............................................................. C-8
2.2 Quality Control Data Format.............................................. C-12
2.3 Inquiry Data Format ........................................................... C-14
2.4 Order Information Data Format.......................................... C-15
3. ID BAR CODE...................................................................................... C-17
3.1 Applicable Bar Codes......................................................... C-17
3.2 Dimensions of Elements..................................................... C-18
3.3 Requirements on Wide/Narrow Ratio ................................ C-18
3.4 Optical Requirements ......................................................... C-18
3.5 Dimensions of Bar Code Label........................................... C-20
3.6 Check-Digit......................................................................... C-20
3.7 Applicable Characters......................................................... C-28
3.8 Effective Bar Code Length ................................................. C-28
Sysmex SF-3000 Operator's Manual -- Revised September1995 ix
CHAPTER 1 INTRODUCTION
1. INTRODUCTION ............................................................... 1-1
2. OPERATOR'S MANUAL ORGANIZATION............................... 1-2
3. INFORMATIONAL HEADINGS ............................................. 1-3
3.1 NOTE, CAUTION and WARNING.................................... 1-3
3.2 Document Conventions ................................................... 1-3
4. SYSTEM OVERVIEW .......................................................... 1-4
5. SYSTEM OPTIONS............................................................. 1-5
6. SAFETY ........................................................................ 1-6
6.1 General Safety ............................................................. 1-6
6.2 Hazardous and Biohazardous Material................................. . 1-6
6.3 Reagent Safety ............................................................. 1-6
6.4 Laser Safety ................................................................ 1-7
7. OPERATIONAL SUMMARY.................................................. 1-8
8. ANALYSIS PARAMETERS ................................................... 1-9
9. DISPLAY SCREEN ........................................................... 1-10
9.1 LCD (Liquid Crystal Display) Screen................................. 1-10
9.2 Root Menus .............................................................. 1-14
9.3 Hard Copy................................................................ 1-16
10. PASSWORD.................................................................... 1-17
11. EMERGENCY SHUTDOWN PROCEDURE ............................. 1-18
12. ALARMS........................................................................ 1-18
13. INSTALLATION REQUIREMENTS....................................... 1-19
13.1 Relocation Information.................................................. 1-19
13.2 Electrical Requirements ................................................. 1-19
13.3 Space Requirements..................................................... 1-20
13.4 Installation Environment................................................ 1-20
14. SYSTEM SPECIFICATIONS................................................ 1-21
Revised September 1995
INTRODUCTION
1. INTRODUCTION
The Sysmex® SF-3000 is a technically advanced, computerized, fully automated hematology analyzer with many features, for in vitro diagnostic use in clinical laboratories. The SF-3000 provides accurate screening for patients whose hematological abnormalities indicate the need for further testing. In addition, it can contribute in the diagnosis and therapeutic monitoring of patients.
The SF-3000 has the capability of analyzing up to 80 samples per hour, and display 4 different patterns -- WBC 5 differential, scattergrams for white blood cells and basophils, and cell size distribution curves for red blood cells and platelets, as well as 23 analysis data parameters on the color LCD (liquid crystal display) screen.
Chapter 1 is an introduction to this manual, major system components, system operation and other general considerations. This chapter should be read before operating the SF-3000. Chapter 1 contains the following subjects:
Manual Organization
A description of the Operator's Manual and explanation of important informational headings.
System Overview
An introduction to the main elements of the SF-3000 analyzer, including a description of the options available to enhance the instrument's operation.
Safety Summary
Covers major safety considerations when using and servicing the SF-3000.
Operational Summary
A summary of the operating procedures for each mode, the LCD screen display, functions of touch panel, etc.
Installation Requirements
Includes space requirements, necessary equipment, installation environment and other essential information to be reviewed before installation of the SF-3000.
Instrument Specifications
The instrument's specifications are given in a reference table.
Sysmex SF-3000 Operator's Manual -- Revised September 1995 1-1
INTRODUCTION
2. OPERATOR'S MANUAL ORGANIZATION
The SF-3000 Operator's Manual has been designed with the operator in mind. Each chapter has its own table of contents and is designed to facilitate rapid location of appropriate information.
Table 1-1: Manual Organization
CHAPTER 1 Introduction
CHAPTER 2 Sample Processing
CHAPTER 3 Work List
CHAPTER 4 Result Interpretation/ Reports
CHAPTER 5 Maintenance and Supplies
CHAPTER 6 Quality Control
CHAPTER 7 Calibration
Contains basic information about the instrument; operating procedures, screen displays, touch panel, installation and safety. This chapter must be read prior to operating the Sysmex SF-3000.
Explains sampling procedure from start-up to shutdown. All sampling operation procedures are contained in this chapter.
Explains how to enter order information with the display and management of the records.
Explains procedures for displaying and processing Stored Data, and procedures for analyzed result output. Also explains IP messages.
Explains periodic maintenance, and the procedures for replacing consumables and reagents.
Explains how to run the Quality Control Program. Also explains, for your reference, the quality control system used in this instrument.
Explains the procedures for auto-calibration and manual calibration.
CHAPTER 8 Troubleshooting
CHAPTER 9 Adjustments
CHAPTER 10 Functional Descriptions
CHAPTER 11 System Setup
APPENDICES A, B, C Menu Tree, Installation and Technical Information
Explains error messages and their troubleshooting. Also explains service data and system test functions.
Explains how to adjust pressure and other adjustments.
Gives the main principles of analysis performed by the instrument. Also contains system nomenclature.
Explains how to set date, time, units, sample analysis stop and other system conditions. Also contains data analysis settings -- for abnormal data judgments, etc.
Contains program menu tree, technical information including unpacking check lists, installation procedures, bar-code labeling parameters and host communication protocols.
1-2 Sysmex SF-3000 Operator's Manual -- Revised September 1995
INTRODUCTION
3. INFORMATIONAL HEADINGS
3.1 NOTE, CAUTION and WARNING
NOTE, CAUTION and WARNING boxes throughout this manual are meant to get to attention to important safety and operational information. Always follow the instructions contained in the boxes. Failure to do so may affect the safety or precision features of the SF-3000 analyzer. The boxes are defined as follows:
NOTE: Highlights important facts, gives helpful information, and clarifies
procedures.
CAUTION: Provides information on the correct operation of the SF-3000 analyzer.
Information contained in CAUTION boxes is crucial to prevent damage and to maintain performance of the analyzer.
WARNING! Indicates potentially hazardous situations that could result in serious
injury or infection to laboratory personnel.
3.2 Document Conventions
The SF-3000 Operator's Manual uses the following conventions:
"Quotations": Screen commands, messages, and status information that the SF­3000 system displays appear within quotation marks. For example:
"All Samples", "Ready" or "Input Password"
[Square Brackets]: Names of function keys such as control or operational keys, number keys, or arrow keys that you select on the SF-3000 appear within square brackets. For example:
[Enter], [Sampler], [2] or [↑]
Italics: Application names and reference material appear in italic form. For example:
Refer to Chapter 2: Sample Processing.
Sysmex SF-3000 Operator's Manual -- Revised September 1995 1-3
INTRODUCTION
4. SYSTEM OVERVIEW
The purpose of the SF-3000 is to provide accurate results on 23 parameters and to detect abnormalities in the sample. To assist the laboratory in the screening of abnormalities, the SF-3000 analyzes and processes the data obtained from the analyzer unit, and the LCD displays and outputs either a POSITIVE or a NEGATIVE message for each sample. A NEGATIVE message signifies that parameter values for the sample are within acceptable limits and the sample does not require any additional verification of those values. A POSITIVE message signifies that the sample is not within the acceptable limits and requires further review and investigation. Proper use of the instrument requires each laboratory to establish the acceptable limits for results.
The SF-3000 uses the optical detector block incorporating the semiconductor laser to analyze the WBC population. In the DIFF channel, lymphocytes, monocytes, eosinophils, and the group of neutrophils and basophils are analyzed to determine the WBC 4-differentials using flow cytometry. Basophil determination and WBC number counting are performed in the BASO channel. RBCs and PLTs are analyzed by the RBC detector block using the DC detection method. HGB determination is performed using the SLS hemoglobin detection method.
The SF-3000 consists of two major systems.
• Main Unit : Houses the hydraulic and electronic systems and their control components. The unit analyzes, processes and displays the data on the LCD screen.
• Pneumatic Unit : Supplies the required pressure and vacuum for analysis.
Main Unit
Sampler Unit (Optional)
Pneumatic Unit
Figure 1-1: Sysmex SF-3000 Hematology Analyzer
1-4 Sysmex SF-3000 Operator's Manual -- Revised September 1995
INTRODUCTION
5. SYSTEM OPTIONS
Several options are available to enhance system efficiency. Available options for the SF-3000 are:
• ID Bar Code Reader : Reads the ID numbers of bar code labeled samples, and inputs the numbers automatically.
• Color Graphics Printer : Prints out analysis results (cell size distribution
or Page Printer graphs, scattergrams) and hard copies of screens in
color or black and white. Printing can be done both in graphic and list format.
• Data Printer : Prints the analysis data in ticket format.
• (Cap Piercing) Sampler Unit : Consists of a mixer and a cap piercer unit, and loads up to 5 sample racks (50 sample tubes) that enable an automated closed sampling system.
• Manual CP Unit : Consists of a mixer and a cap piercer unit which enables a manual closed sampling system.
Sysmex SF-3000 Operator's Manual -- Revised September 1995 1-5
INTRODUCTION
6. SAFETY
The operator must follow the instructions in this section. It contains important information to operate the SF-3000 analyzer safely.
6.1 General Safety
While operating, maintaining, servicing or repairing the system, follow all procedures contained in this manual. The operator must observe all NOTES, CAUTIONS and WARNINGS posted anywhere on the instrument or given in this manual.
Do NOT touch the electrical circuits behind the enclosure panels of the SF-3000. Touching the circuits is dangerous and may give you an electrical shock, especially if your hands are wet.
Use only designated tools and parts for service and repair. Substitute parts should never be used, and the SF-3000 should not be modified in any way.
Keep hair, clothing and fingers away from all moving parts. Install the Sampler Unit on a table or work bench to prevent the system from accidentally
falling.
6.2 Hazardous and Biohazardous Material
All surfaces and components in contact or potentially in contact with patient blood samples should be considered contaminated. Use of protective garments and gloves is strongly recommended when operating, maintaining, or servicing the SF-3000.
Do not touch the waste when disposing of it or assembling/disassembling the associated parts. If accidental contact with waste or any other potentially biohazardous material occurs, flush the affected area immediately with water and follow your laboratory's prescribed cleaning and decontamination procedures.
Consider all regulations applicable to your laboratory when operating the Sysmex SF-3000 instrument.
6.3 Reagent Safety
If reagent comes into contact with skin or clothing, flush it with water. If eyes are affected, flush with copious amounts of water and obtain medical advice if necessary.
1-6 Sysmex SF-3000 Operator's Manual -- Revised September 1995
INTRODUCTION, Safety
6.4 Laser Safety
The SF-3000 uses a semiconductor laser unit. Though this laser unit is placed in the shield box, the operator must observe all NOTES, CAUTIONS and WARNINGS concerning laser handling.
WARNING!: DO NOT remove the shield box cover of the Laser Unit.
NOTE: This caution label is located
inside the Laser Unit Cover.
< Top View >
Semiconductor Laser Unit Cover
< Left Side View >
Figure 1-2: Location of Laser Unit and Labels
(Left Interior of the Main Unit)
Refer to Chapter 5, Section 6 for further information on laser handling.
Sysmex SF-3000 Operator's Manual -- Revised September 1995 1-7
INTRODUCTION
7. OPERATIONAL SUMMARY
The SF-3000 has two basic operating modes: the Manual Open Mode and Capillary Mode. Additional three operating modes are available by means of optional units: the Sampler Mode and Manual Closed Mode by means of Cap Piercing Sampler Unit, and Manual CP Mode by means of Manual CP Unit.
Table 1-2: Operation Modes
Manual Open
Mode
Select
manual mode
Set manual
sample ID
Set sample at manual Place sample in rack Place sample
aspiration pipette
Press the Start Switch
Capillary Mode Sampler Mode Manual Closed
Mode
Operator checks
Turn ON power
Self-check
Auto rinse
Ready
Select
capillary mode
Prepare
capillary
analysis
sample
(1:5 dilution) Set capillary
sample ID
Analysis performed
Analysis complete
Post-analysis check
Perform shutdown
Press
[Sampler]
Set sample ID
(or read bar
code label)
Set rack No.
Set tube No.
Set rack on sampler in Manual CP
Press [Start] Press the
Power OFF
Select
closed mode
Set closed
sample ID
Start Switch
Manual CP
closed mode
Set closed
sample ID
Unit
Press the
Start Switch
Mode
Select
Operations performed by the operator are indicated in bold print. Ready: READY LED turns on and "Ready" message is displayed on the LCD screen.
In this state, various operations can be performed, including analysis setting and data processing.
1-8 Sysmex SF-3000 Operator's Manual -- Revised September 1995
INTRODUCTION
8. ANALYSIS PARAMETERS
The SF-3000 uses 4 detection methods and 5 types of reagents to analyze the following 23 parameters:
Table 1-3: Analysis Parameters
Parameter Acronym Detection Method
White Blood Cell Count WBC Flow Cytometry by Semiconductor Laser Red Blood Cell Count RB C DC Hemoglobin Concentration HGB SLS hemoglobin Hematocrit (true relative percentage volume
of erythrocytes) Mean Corpuscular (erythrocyte) Volume MCV Computed from RBC and HCT Mean Corpuscular Hemoglobin MCH Computed from RBC and HGB Mean Corpuscular Hemoglobin
Concentration Platelet Count PLT DC Neutrophil Percent NEUT% Lymphocyte Percent LYMPH% Monocyte Percent MONO% Flow Cytometry by Semiconductor Laser Eosinophil Percent EO% Basophil Percent BASO% Neutrophil Count NEUT# Lymphocyte Count LYMPH# Monocyte Count MONO# Flow Cytometry by Semiconductor Laser Eosinophil Count EO# Basophil Count BASO# RBC Distribution Width RDW-SD Computed RBC Distribution Width RDW-CV Computed Platelet Distribution Width PDW Computed Mean Platelet Volume MPV Computed Platelet Large Cell Ratio P-LCR Computed
H CT RBC Cumulative Pulse Height Detection
MCHC Computed from HCT and HGB
NOTE:
Customers in the United States:
Platelet Distribution Width (PDW) and Platelet Large Cell Ratio (P-LCR) parameters have not been approved for reporting by the Food & Drug Administration (FDA). The obtained values should be excluded from all print forms until reporting approval has been obtained. See
Chapter 11
for information on excluding these
values.
Sysmex SF-3000 Operator's Manual -- Revised September 1995 1-9
INTRODUCTION
9. DISPLAY SCREEN
9.1 LCD (Liquid Crystal Display) Screen
The LCD screen is divided into 3 parts: the System Status Area, the Data Processing Area, and the Menu Area.
1. System Status Area
2. Data Processing Area
3. Menu Area
Figure 1-3: Display Screen
1 . System Status Area
The System Status Area appears as the top two lines of the screen (Figure 1-4). This area displays Main Unit status information such as analysis status, errors, etc.
It also displays data processing status information such as Peripherals, X M, etc. The [Sysmex] and [Sampler] function keys also appear in this area.
Sysmex
Ready Manual Mode DP: 1234567890123 XM H C G P D P S U I D
Next No.1234567890123
Sampler
Figure 1-4: System Status Area
• Analysis Status
System status -- "Ready", "Not Ready", etc. is displayed to the left of the top line. Analysis mode and the next sample ID number --
Analysis mode in which the system is set, and the next sample number to be analyzed in the selected analysis mode are displayed. Pressing this keypad displays the Sample No. Setting Screen for the Open Sampling, Closed Sampling, or Capillary Sampling Manual mode. Using this setting screen, the analysis mode, next sample ID number for the selected analysis mode can be set up. When the Capillary mode is selected, this area is displayed in yellow back-light.
1-10 Sysmex SF-3000 Operator's Manual -- Revised September 1995
INTRODUCTION, LCD Screen
NOTE: To set the next Sample ID No., Rack No. and Tube Position No. to be
analyzed in the auto mode by means of Sampler Unit, press [Sampler] keypad to display the auto mode setting window.
The DP No. is displayed below the system status. If the Data Printer (DP) is the selected output device, the DP No. displayed indicates the next sample data number to be printed out.
Errors -- "2.0 kg/cm
2
Error", "Rack Move Error", etc. is displayed below the system status, in place of the DP No. If 2 or more errors occur simultaneously, they are displayed in order of importance. When an error is displayed, press [Sysmex] key to display the action/help messages provided in the Error Log program. Refer to Chapter 8: Troubleshooting for the action message display.
• Data Processing Status
X M : Indicates the status of X M control (one file of the QC program) in the
following way:
No indication : X M control is not in use (Stop).
X M :XM control is in use (Start). X M (with red back-light) : X M Limit Error has occurred.
HC : Indicates transmission status of data to the Host Computer.
No indication : The Host Computer is set to "Not Connected". HC : Ready for transmission to Host Computer. HC (with green back-light) : Now transmitting to Host Computer. HC (with red back-light) : Transmission to Host Computer not occurring
because of abnormality in Host Computer.
HC (with yellow back-light) : Error ("Not Transmissible", "No Ack" or "Ack
Code Err") has occurred between SF-3000 and Host Computer.
GP : Indicates the status of the Graphic Printer (or Line Printer).
No indication : The Graphic Printer is set to "Not Connected". GP : The Graphic Printer is ready. GP (with green back-light) : Data being output to Graphic Printer. GP (with red back-light) : Printing not possible because of abnormality in
Graphic Printer.
DP : Indicates the status of the Data Printer.
No indication : The Data Printer is set to "Not Connected". DP : The Data Printer is ready. DP (with green back-light) : Data being output to Data Printer. DP (with red back-light) : Printing not possible because of abnormality in
Data Printer.
Sysmex SF-3000 Operator's Manual -- Revised September 1995 1-11
INTRODUCTION, LCD Screen
SU : Indicates the status of the Sampler Unit.
No indication : The Sampler Unit is not connected. SU : Sampler Unit ready for sampler analysis. SU (with red back-light) : Sampler not operational because of abnormality
in Sampler Unit.
CP : Indicates the status of the Manual Cap Piercing (CP) Unit.
No indication : The Manual CP Unit is not connected. CP : Manual CP Unit ready for manual closed mode
analysis.
CP (with red back-light) : Manual closed mode not operational because of
abnormality in Manual CP Unit.
ID : Indicates the status of the ID Bar Code Reader.
No indication : The Bar Code Reader is set to "Not
Connected". ID : The Bar Code Reader is ready. ID (with red back-light) : "ID Unit Com. Error" has occurred between
SF-3000 and Bar Code Reader.
HD (with green backlight) : Appears when the system hard disk is being accessed.
• Function Keys
The [Sysmex] and [Sampler] keypads appear at each end of this area. [Sysmex] -- Press this key to obtain the hard copy of screen and to access the Error Log.
Refer to Section 9.3 in this chapter for hard copy output. Refer to Chapter 8: Troubleshooting for Error Log. When an error occurs, this key changes to [Alarm Reset] with red backlight. Press to stop the alarm.
[Sampler] -- Press to display the sampler start check window, where the Sample ID No., Rack No. and Tube Position No. for the next auto mode analysis can be set up. This keypad changes to [Sampler Stop] during auto mode analysis.
2 . Data Processing Area
Analysis and sample information, including analysis data, scattergrams, cell size distributions, QC menus, action messages, sub-program menu keypads, etc. are displayed in the center area of the display screen.
1-12 Sysmex SF-3000 Operator's Manual -- Revised September 1995
INTRODUCTION, LCD Screen
3 . Menu Area
The available menu choices are displayed in the bottom line of the display screen. Touch the desired keypad on the LCD to access and proceed for the program. In the Main Screen, the Root Menus appear in this area. Refer to Section 9.2 in this chapter for the root menus.
NOTE: The program keys masked as shown below do not function when
pressed.
Figure 1-5: Example of Masked Program Keys
4 . Power Saving Function
The LCD contrast will automatically decrease for the LCD power saving if the Main Unit does not detect any key operation on the LCD for 5 minutes. Touch anywhere on the LCD to exit the power saving mode.
Sysmex SF-3000 Operator's Manual -- Revised September 1995 1-13
INTRODUCTION
9.2 Root Menus
When the instrument power is ON, the Main Screen with the Root Menus is displayed as the initial screen. By pressing the [Return] key on any screen, the visible display returns to the previous screen, finally to the Main Screen. The SF-3000 provides twelve Root Menus. The Main Screen displays seven Root Menus on the menu line at a time. When you want to change a menu, press the [More] key to alternate root menu.
The Root Menus is listed below. Each Root Menu consists a second menu(s) or menu choices to proceed for the corresponding program.
[Status]
Use this menu to check the analyzer condition, analysis process, sensor status, etc. at any time. (This menu does not display analysis errors.)
[Work List]
Use this menu to display, register, and process the analysis information, including Sample No., Rack No., Tube Position, Order Information, etc. Refer to Chapter 3: Work List for more information.
[Stored Data]
This menu provides options to display analysis results up to 1,000 samples stored in the memory. The Stored Data List includes Date and Time analyzed, Sequential No., Sample No., Rack No., Tube Position, output status to the peripherals, flag information and analysis results. Refer to Chapter 4: Result Interpretation/Reports for more information.
[QC]
The SF-3000 quality control program provides X or L-J, and X M control applications. The QC Root Menu performs QC analysis, displays and/or outputs the QC
Chart, establishes the QC settings, etc. Refer to Chapter 6: Quality Control for more information.
[GP Print]
Use this menu to get options to output the data currently displayed on the screen to the Graphic Printer.
[DP Print]
Use this menu to get options to output the data currently displayed on the screen to the Data Printer.
[Replace Reagent]
Use this menu after replacing a reagent container to prime the reagent into internal reservoir chamber.
1-14 Sysmex SF-3000 Operator's Manual -- Revised September 1995
INTRODUCTION, Root Menu
[Mainte.]
Use this menu to perform the customer maintenance programs, such as waste chamber cleaning, clog removal, etc. and to perform the system test programs.
[Settings]
Use this menu to set the system parameters and conditions, such as date, time, units, analysis stop condition, etc. Also this program contains data analysis settings to establish certain standards for the SF-3000 system. System's operational parameters can be set up to meet individual laboratory preferences to customize the operation of the SF-3000. Refer to Chapter 11: System Setup for the setup procedure.
[Calib.]
Use this menu to calibrate the SF-3000 for specified parameter(s) automatically or manually. Refer to Chapter 7: Calibration for the procedure.
[Shutdown]
Use this menu to clean the detector chambers and all hydraulic lines in the SF-3000 system with detergent.
[Auto Rinse]
Use this menu to rinse the hydraulic lines with the diluents, and check the background values after rinsing. If the background values exceed the preset limit values, a "Background Error" occurs.
Sysmex SF-3000 Operator's Manual -- Revised September 1995 1-15
INTRODUCTION
9. 3 Hard Copy
The [Sysmex] keypad always appears on the left of the top line of the screen. Press this key to display the Sysmex submenu window as shown in Figure 1-6.
Sysmex
Status
Ready
DP:1234567890123
Hard Copy
Error
Log
Cancel
Work
List
Manual Mode Next No.1234567890123
NO. R :
WBC NEUT
LYMPH MONO
EO BASO RBC
HGB HCT
MCV MCH MCHC
RDW-SD RDW-CV
PLT PDW MPV
P-LCR
Q C
G P
Print
Stored
Data
B A S O
40fL
XM HC GP DP SU
3
[x10 /uL]
6
[x10 /uL] [g/dL]
[%] [fL]
[pg] [g/dL] [fL]
[%]
3
[x10 /uL] [fL]
[fL] [%]
D P
Print
Replace Reagent
[%] [%]
[%] [%]
[%]
Sampler
WBC Flag
RBC Flag
PLT Flag
More
Figure 1-6: Sysmex Submenu Window
[Hard Copy]
Pressing this key outputs the hard copy of screen (screen shot), as displayed on the LCD at the time of pressing the [Hard Copy] keypad, to the Graphic Printer. This function is available in any status of instrument operation. The window will close automatically after pressing this key.
[Error Log]
Pressing this key displays the error log and action/help messages for a specified error. Refer to Chapter 8: Troubleshooting.
[Cancel]
Pressing this key closes the Sysmex submenu window.
1-16 Sysmex SF-3000 Operator's Manual -- Revised September 1995
INTRODUCTION
10. PASSWORD
Some programs in Q.C., Settings and Calibration require a password entry to prevent unauthorized changes of the important settings and values. When such a program is selected, the Password Input Screen appears with the message "Input Password". Enter the registered password and press the [Enter] key. If the entered password is correct, the program will be executed.
Sysmex
Ready
DP:1234567890123
Manual Mode Next No.1234567890123
XM HC GP DP SU
Input Password
Password
***
7 8
4
1 2 3
0 Ð Enter
C
.
Cancel
Sampler
9
65
Figure 1-7: Password Entry Screen
The password is important for the management of the SF-3000, so be sure to memorize it and/or have aids to help you remember it. Should you forget it, consult your Sysmex service representative.
The password can consist of up to 12 digits. If you set the password to "0", no password check will be performed, and the programs will be executed without the need of password input.
For the procedures for setting and changing the password, refer to Chapter 11, "System
Setup".
Sysmex SF-3000 Operator's Manual -- Revised September 1995 1-17
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