automated hematology analyzer sf-3000

605 Pages·1999·3.98 MB·English

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.
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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)
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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/cm2 ........................................................9-4
3.2 Adjusting the Vacuum ............................................................9-5
4. MAIN UNIT ADJUSTMENT ..................................................................9-5
4.1 Adjusting to 0.6 kg/cm2 .........................................................9-6
4.2 Adjusting to 0.5 kg/cm2 .........................................................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