BC-5150/BC-5000 AUTO HEMATOLOGY ANALYZER
SERVICE MANUAL
Introduction Before starting to service this instrument, please read this manual thoroughly for proper service. After reading this manual, make sure it is well kept so that it is available when needed. Product Name: Auto Hematology Analyzer Model: BC-5150/BC5-5000 Registered Address: F1-4, Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen Production Address: Building A3, Honghualing Industrial Park, Liuxian Road, Nanshan, Shenzhen
Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this manual and the relevant product. © 2012 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved. Release, amendment, reproduction, distribution, rent, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
,
,
,
are registered trademarks or trademarks
owned by Mindray. Microsoft Corporation owns the copyright of SQL SERVER 2005 EXPRESS EDITION. ©2005 Microsoft Corporation. All rights reserved.
Statement Mindray is responsible for safety, reliability and performance of this product only in the condition that: all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; all replacement parts and supporting accessories and consumables involved in the service are original Mindray parts or Mindray authorized parts;
Ⅰ
the relevant electrical installation complies with the applicable national requirements; the product is operated in accordance with this service manual.
Repair Service Free Service: Free service is provided for any product within the scope specified by Mindray warranty rules. Paid Service: Mindray offers paid service for any product beyond the scope specified by Mindray warranty rules;
even during the warranty period, only paid service is available if the need for service is caused by the following reasons: artificial damage; improper use; grid voltage beyond the specified range of the device; irresistible natural disasters; replacement with parts and consumables not authorized by Mindray or service work by personnel not authorized by Mindray.
Return Procedure In the event that it becomes necessary to return this product or part of this product to Mindray, the following procedure should be followed:: Obtain return authorization: Contact the Mindray Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Returned shipments will not be accepted if the Mindray number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return. Freight policy: The customer is responsible for freight charges when shipping the product to Mindray for service (including customs charges).
Company Contact Manufacturer:: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen Postal Code: 518057 Website: www.mindray.com 24-hour Service Hotline: 4007005652 Phone: +86 755 81888998 Fax:
+86 755 26582680
II
This system is only intended for use by qualified service personnel trained by Mindray or Mindray's agents. It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or injury of human health. Be sure to operate the analyzer under the situation specified in this manual; otherwise, the analyzer will not work normally and the analysis results will be unreliable, which would damage the analyzer components and cause personal injury.
This manual is only provided for qualified service personnel trained by Mindray or Mindray's agents.
III
Table of Contents 1 1.1 1.2 1.3 1.4 1.5 1.6
Overview .................................................................................................................... 1-1 Overview ..................................................................................................................... 1-1 Who Should Read This Manual .................................................................................. 1-1 How to Find Information ............................................................................................ 1-1 Conventions Used in This Manual .............................................................................. 1-2 Special Terms Used in This Manual............................................................................ 1-2 Symbol ........................................................................................................................ 1-4
2
Specifications ............................................................................................................. 2-1 2.1. Product Name .............................................................................................................. 2-1 2.1.1 Physical Specifications ....................................................................................... 2-2 2.1.2 Electrical Specifications ..................................................................................... 2-2 2.1.3 Environment Requirements ................................................................................ 2-3 2.1.4 Specifications ..................................................................................................... 2-3 2.2. Testing Parameters ...................................................................................................... 2-3 2.3. Performance Requirements ......................................................................................... 2-5 2.3.1 Background/Blank Count ................................................................................... 2-5 2.3.2 Carryover ........................................................................................................... 2-5 2.3.3 Repeatability ...................................................................................................... 2-6 2.3.4 Linearity Range .................................................................................................. 2-7 2.4. Display Range ............................................................................................................. 2-8 2.5. Product Description..................................................................................................... 2-8 Main unit ................................................................................................................... 2-12 Power/Status indicator............................................................................................... 2-12 Power switch ............................................................................................................. 2-12 [Aspirate] key ............................................................................................................ 2-13 USB port ................................................................................................................... 2-13 2.6. Product Configuration ............................................................................................... 2-13 2.7. Reagents, Controls and Calibrators ........................................................................... 2-13 2.7.1 Reagents ........................................................................................................... 2-14 2.7.2Reagent Consumption Volume .................................................................................... 2-14 2.7.3 Controls and Calibrators................................................................................... 2-15 2.8. Information Storage Capacity ................................................................................... 2-15
3
Operation Principles ................................................................................................. 3-1 Overview ..................................................................................................................... 3-1 Workflow..................................................................................................................... 3-1 Sample aspiration ........................................................................................................ 3-2 White Blood Cell Measurement .................................................................................. 3-2 Laser flow cytometry .................................................................................................. 3-2
3.1 3.2 3.3 3.4
1
Table of Contents 3.5
Hemoglobin Concentration Measurement................................................................... 3-3 Colorimetric method ................................................................................................... 3-3 Hemoglobin concentration parameters ........................................................................ 3-3 Impedance method ...................................................................................................... 3-3 Time Measurement ...................................................................................................... 3-4 Red blood cell parameters ........................................................................................... 3-4 Platelet parameters ...................................................................................................... 3-5 3.6 Parameter Flags ............................................................................................................... 3-6
4
Software and Interface.............................................................................................. 4-1 4.1. Start-up ........................................................................................................................ 4-1 Version Check ............................................................................................................. 4-1 4.2. Login ........................................................................................................................... 4-2 4.2.1 Log in using service level username and password............................................ 4-2 4.2.2 Login Check ....................................................................................................... 4-2 4.3. Review ........................................................................................................................ 4-4 4.3.1 Stability Trend Graph ......................................................................................... 4-4 4.3.2 Trend Graph ....................................................................................................... 4-5 4.4. Calibration ................................................................................................................... 4-5 4.4.1 Calibration Factor and Transfer Factor .............................................................. 4-5 4.4.2 Calibration .......................................................................................................... 4-7 4.5. Sample Probe Debug ................................................................................................... 4-8 4.6. Temperature Calibration.............................................................................................. 4-8 4.7. Gain Calibration .......................................................................................................... 4-9 4.8. Gain Setting................................................................................................................4-11 4.9. Performance .............................................................................................................. 4-12 4.9.1 Background test................................................................................................ 4-12 4.9.2 Reproducibility................................................................................................. 4-13 4.9.3 Carryover ......................................................................................................... 4-14 4.9.4 Reference range of normal samples ................................................................. 4-14 4.10. Advance Toolbox ...................................................................................................... 4-15 4.10.1 System Configuration..................................................................................... 4-15 4.10.2 One-key Export .............................................................................................. 4-16 4.11. Software Update ........................................................................................................ 4-17 4.12. Status Indicator.......................................................................................................... 4-18 4.13. Buzzer ....................................................................................................................... 4-18
5
Data Transmission ..................................................................................................... 5-1 5.1. LIS Connection ........................................................................................................... 5-1 5.2. Data Management Software Setup .............................................................................. 5-3 5.3. Communication Error Analysis ................................................................................... 5-4 5.3.1 Physical Connection ........................................................................................... 5-4 5.3.2 Communication Setup ........................................................................................ 5-4 5.3.3 Network Firewall ............................................................................................... 5-4 2
Table of Contents 6 6.1.
6.2.
6.3. 6.4.
7
Optical System ........................................................................................................... 6-1 Introduction to the Principles of Optical System ........................................................ 6-1 6.1.1 Operation Principles ........................................................................................... 6-1 6.1.2 Beam Path of the Optical system ....................................................................... 6-2 Physical Structure........................................................................................................ 6-2 6.2.1 Overall Structure ................................................................................................ 6-2 6.2.2 Light Source Assembly ...................................................................................... 6-4 6.2.3 Flow Cell Assembly ........................................................................................... 6-4 6.2.4 Optical Substrate Assembly ............................................................................... 6-5 6.2.5 Preamplifier and Shield Shell............................................................................. 6-5 6.2.6 Shield Shell Assembly........................................................................................ 6-6 6.2.7 Scattering Detection Assembly .......................................................................... 6-6 6.2.8 Laser Control Board ........................................................................................... 6-7 Determinating the Optical System Status .................................................................... 6-7 Maintenance and Replacement of the Optical System ................................................ 6-9 6.4.1 Maintenance of the Optical System.................................................................... 6-9 6.4.2 Replacement of the Optical System ................................................................. 6-14
Fluidics ....................................................................................................................... 7-1 7.1. Measurement Flow ...................................................................................................... 7-1 7.1.1 WBC&HGB Channel ......................................................................................... 7-2 7.1.2 RBC/PLT Channel.............................................................................................. 7-4 7.2. Sample Volume ........................................................................................................... 7-4 7.3. Temperature of Fluidics .............................................................................................. 7-5 7.4. Reagent Consumption Volume .................................................................................... 7-5 7.5. Introduction to Fluidic Parts........................................................................................ 7-6 7.5.1 Mindray Valves .................................................................................................. 7-6 7.5.2 2-way Mindray Pressure-proof Valve ................................................................. 7-6 7.5.3 LVM Fluidic Valve ............................................................................................. 7-7 7.5.4 Pinch Valve......................................................................................................... 7-7 7.5.5 Liquid Filter ....................................................................................................... 7-8 7.5.6 Syringe Linkage ................................................................................................. 7-9 7.5.7 Electromagnetic Metering Pump ........................................................................ 7-9 7.5.8 preheat bath ...................................................................................................... 7-10 7.5.9 Vacuum Pump ...................................................................................................7-11 7.5.10 Sample Probe ................................................................................................. 7-12 7.5.11 Probe Wipes.................................................................................................... 7-12 7.5.12 Hydraulic pressure sensor .............................................................................. 7-13 7.5.13 1-way Valve .................................................................................................... 7-14 7.5.14 Baths............................................................................................................... 7-14 7.6. Detailed Introduction of Fluidic Structure ................................................................ 7-14 7.6.1 Sampling and dispensing channel .................................................................... 7-15 7.6.2 WBC&HGB Channel ....................................................................................... 7-15 7.6.3 RBC/PLT Channel............................................................................................ 7-17 3
Table of Contents 7.6.4 Precautions for Assembly and Service ............................................................. 7-18 7.7. Introduction to Sequences ......................................................................................... 7-19 7.7.1 Measurement sequence in WB-CBC+DIFF mode ........................................... 7-19 7.7.2 Measurement sequence in PD-CBC+DIFF mode ............................................ 7-32 7.7.3 Measurement sequence in CBC mode.............................................................. 7-33 7.7.4 Introduction to the Maintenance Sequences ..................................................... 7-33 8 8.1.
8.2.
8.3.
8.4.
8.5.
8.6.
8.7.
8.8.
8.9.
Hardware System ...................................................................................................... 8-1 Hardware System Overview........................................................................................ 8-1 8.1.1 Functional Block Diagram ................................................................................. 8-1 8.1.2 Electrical Connection Block Diagram................................................................ 8-2 8.1.3 System Troubleshooting ..................................................................................... 8-2 Digital Control Board.................................................................................................. 8-4 8.2.1 Overview ............................................................................................................ 8-4 8.2.2 Components........................................................................................................ 8-4 8.2.3 Adjustment and Tests ......................................................................................... 8-8 8.2.4 Troubleshooting.................................................................................................8-11 Analog Drive Board .................................................................................................. 8-15 8.3.1 Overview .......................................................................................................... 8-15 8.3.2 Components...................................................................................................... 8-15 8.3.3 Sockets and Indicators...................................................................................... 8-19 8.3.4 Troubleshooting................................................................................................ 8-23 Power Board .............................................................................................................. 8-26 8.4.1 Overview .......................................................................................................... 8-26 8.4.2 Replacement and Connection ........................................................................... 8-27 8.4.3 Troubleshooting................................................................................................ 8-27 Optical Boards........................................................................................................... 8-28 8.5.1 Optical Path and Optical System Workflow ..................................................... 8-28 8.5.2 Functions of Optical Boards............................................................................. 8-29 8.5.3 Troubleshooting................................................................................................ 8-31 Touchscreen Drive Board .......................................................................................... 8-33 8.6.1 Overview .......................................................................................................... 8-33 8.6.2 Components...................................................................................................... 8-33 8.6.3 Troubleshooting................................................................................................ 8-33 Indicator Board ......................................................................................................... 8-34 8.7.1 Overview .......................................................................................................... 8-34 8.7.2 Components...................................................................................................... 8-34 8.7.3 Troubleshooting................................................................................................ 8-35 Motor, Photocoupler and Microswitch ...................................................................... 8-35 8.8.1 Overview .......................................................................................................... 8-35 8.8.2 Troubleshooting................................................................................................ 8-36 Liquid sensor board ................................................................................................... 8-37 8.9.1 Overview .......................................................................................................... 8-37 8.9.2 Composition ..................................................................................................... 8-37 4
Table of Contents 8.9.3 Troubleshooting................................................................................................ 8-37 9
Heating System .......................................................................................................... 9-1 9.1. Heating System Overview........................................................................................... 9-1 9.2. Heating System ........................................................................................................... 9-1 9.2.1 Diluent Heating System ..................................................................................... 9-1 9.2.2 Optical heating system ....................................................................................... 9-3
10
Mechanical System .................................................................................................. 10-1 10.1. Mechanical System Overview................................................................................... 10-1 Front view ................................................................................................................. 10-1 Back view.................................................................................................................. 10-2 Left view ................................................................................................................... 10-4 Left view ................................................................................................................... 10-6 10.2. Components .............................................................................................................. 10-6 10.2.1 Introduction .................................................................................................... 10-6 10.2.2 Overall ............................................................................................................ 10-7 10.2.3 Main unit ........................................................................................................ 10-8 10.2.4 Panel Module (BC-5150) ............................................................................. 10-12 10.2.5 Panel Module (BC-5000) ............................................................................. 10-13 10.2.6 Syringe Assembly......................................................................................... 10-14 10.2.7 Sample Probe Assembly ............................................................................... 10-15 10.2.8 RBC count pool module ............................................................................... 10-16 10.2.9 HGB count pool module .............................................................................. 10-17 10.2.10 Pump Assembly.......................................................................................... 10-18 10.2.11 Power Backplane Assembly ....................................................................... 10-18 10.2.12 Optical System ........................................................................................... 10-20 10.2.13 Power Assembly ......................................................................................... 10-21 10.3. Removal and Installation......................................................................................... 10-21 10.3.1 Tools ............................................................................................................. 10-21 10.3.2 Preparation for Disassembly ........................................................................ 10-21 10.4. Disassembling the Main Unit .................................................................................. 10-22 10.4.1 Removing the Back plate ............................................................................. 10-23 10.4.2 Removing the Analog drive board PCBA .................................................... 10-23 10.4.3 Removing the Pinaster board or the SD card ............................................... 10-24 10.4.4 Removing the power backplate Assembly ................................................... 10-25 10.4.5 Removing the Fan Assembly........................................................................ 10-26 10.4.6 Removing the Right Panel............................................................................ 10-26 10.4.7 Removing the RBC count pool module(FRU) ............................................. 10-27 10.4.8 Removing the Ruby Red Cell Counter(D50um) .......................................... 10-28 10.4.9 Removing the HGB amp module ................................................................. 10-29 10.4.10 Removing the Liquid detect board PCBA .................................................. 10-31 10.4.11 Removing the Reagent Bottle plate cosmetic piece ................................... 10-31 10.4.12 Removing the preheat Assembly ................................................................ 10-32 5
Table of Contents 10.4.13 Removing the Electromagnet Pinch Valve Assembly ................................ 10-33 10.4.14 Removing the Right Valve Assembly ......................................................... 10-34 10.4.15 Removing the Pump ................................................................................... 10-35 10.4.16 Removing the Vacuum Chamber Assembly ............................................... 10-36 10.4.17 Removing the Top Cover ........................................................................... 10-36 10.4.18Removing the Temperature detection assembly .......................................... 10-37 10.4.19 Removing the Sampling Probe Assembly .................................................. 10-37 10.2.20 Replace the Horizontal Motor of the Sampling Probe Assembly............... 10-38 10.4.21 Replace the Vertical Motor of the Sampling Probe Assembly ................... 10-39 10.4.22 Removing the Probe wipe .......................................................................... 10-39 10.4.23 Replacing the Sample Probe ...................................................................... 10-40 10.4.24 Removing the Syringe Motor Position Sensor ........................................... 10-41 10.4.25 Removing the transducer discreteness ....................................................... 10-42 10.4.26 Removing the Panel Module ...................................................................... 10-43 10.4.27 Removing the Indicator board PCBA ........................................................ 10-43 10.4.28 Removing the 6301 touch control board PCBA ......................................... 10-44 10.4.29 Removing the Touch Panel......................................................................... 10-45 10.4.30 Removing the LCD Module ....................................................................... 10-46 10.4.31 Removing the Microswitch Assembly ....................................................... 10-46 10.4.32 Removing the Syringe ................................................................................ 10-47 10.4.33 Removing the Syringe Motor ..................................................................... 10-48 10.3.34 Removing the Syringe Motor Position Sensor Assembly .......................... 10-49 10.4.35 Removing the liquid detect assembly......................................................... 10-49 10.4.36 Removing the Electromagnetic Pump/Valve from the Front Panel............ 10-50 10.4.37 Removing the Left Door Assembly ............................................................ 10-51 10.4.38 Removing the Optical System .................................................................... 10-52 10.4.39 Removing the Optical System Cover ......................................................... 10-52 10.4.40 Replacing the RBC/WBC Isolation Chamber Filter .................................. 10-52 10.4.41 Replacing the Power Board PCBA ............................................................ 10-53 11
Troubleshooting ........................................................................................................11-1
12
Debug........................................................................................................................ 12-1 12.1 Mechanical Position Adjustment ................................................................................. 12-1 12.2 Commissioning of detection elements ........................................................................ 12-2 12.2.1 Calibrate and verify the preheat temperature ................................................. 12-2 12.2.2 Counting channel measurement .................................................................. 12-3
13
Commissioning and Verification After Servicing ................................................. 13-1
14
Service BOM ............................................................................................................ 14-1
15
Appendices ............................................................................................................... 15-1
6
Table of Contents A.
Fluidic diagram ........................................................................................................ A-1
B.
Connection and Tube ................................................................................................ B-1
C.
Hardware block diagram......................................................................................... C-1
D.
Cables and Wires ...................................................................................................... D-2
E.
Appendix Table .......................................................................................................... E-1
7
1 Overview 1.1 Overview This chapter describes how to use the service manual. In this manual, the repair methods of BC-5150/BC-5000 are described in detail. Before servicing BC-5150/BC-5000, please carefully read and understand the content in order to properly carry out equipment maintenance and ensure the safety of service personnel. This manual must be used in conjunction with the BC-5150/BC-5000 Operator’s manual. It does not contain information and procedures already covered in the Operator’s manual of BC-5150/BC-5000.
Be sure to operate and service the analyzer strictly as instructed in this manual and the operator’s manual.
1.2 Who Should Read This Manual To use this manual effectively, you need to have the following capacities:
Comprehensive knowledge of electric circuit and fluidic system; Comprehensive knowledge of reagents; Comprehensive knowledge of quality control; Thorough understanding of troubleshooting; The ability to operate the analyzer skillfully The ability to use basic mechanical tools and understand related terminology; The ability to use a digital voltmeter and an oscilloscope masterly; And the ability to read pneumatic/hydraulic schematics and understand related terminology.
1.3 How to Find Information This manual contains 14 chapters and 4 appendices. Refer to the table below to find the information you need. If you want to
See
BC-5150/BC-5000's physical specifications
Chapter 2 Specifications
BC-5150/BC-5000's parameters, respective ranges and test principle
Chapter 3 Operation Principles
interface introduction and upgrading of BC-5150/BC-5000's software
Chapter 4 Software and Interface 1-1
Overview
BC-5150/BC-5000's external interface settings
Chapter 5 Data Transmission
learn about the optical system of BC-5150/BC-5000's and
Chapter 6 Optical System
its maintenance methods
composition, dosage, basic channels and time sequence of BC-5150/BC-5000's fluidic system
Chapter 7 Fluidic System
BC-5150/BC-5000's hardware structure; composition, commissioning and testing point and troubleshooting of each board
Chapter 8 Hardware System
BC-5150/BC-5000's heating principle
Chapter 9 Heating System
BC-5150/BC-5000's error and troubleshooting
Chapter 10 Troubleshooting
BC-5150/BC-5000's structure, disassembly and verification
Chapter 11 Mechanical System
Debug after BC-5150/BC-5000 being serviced
Chapter 12 Debug
Debug and verification after BC-5150/BC-5000 being serviced
Chapter 13 Debug and Verification After Servicing
BC-5150/BC-5000's service BOM
Chapter 14 Service BOM
BC-5150/BC-5000's fluidic diagrams
Appendix A Fluidic Diagrams
BC-5150/BC-5000's fluidic tube connectors
Appendix B Lists of tube connectors
BC-5150/BC-5000's hardware diagrams
Appendix C Hardware Diagrams
BC-5150/BC-5000's cables and wires
Appendix D Cables and Wires
1.4 Conventions Used in This Manual This manual uses certain typographical conventions to clarify meaning in the text:
Format
Meaning
[××]
all capital letters enclosed in [ ] indicate a key name (either on the pop-up keyboard or the external keyboard)
“××”
letters included in " " indicate text you can find on the screen of BC-5150/BC-5000 italic letters indicate titles of the chapters that are referred
×× to
All illustrations in this manual are provided as examples only. They may not necessarily reflect your analyzer setup or data displayed.
1.5 Special Terms Used in This Manual You will find the following symbols in this manual. When you read <
It means <
1-2
Overview read the statement below the symbol. The statement is alerting you to a potentially biohazardous condition. read the statement below the symbol. The statement is alerting
WARNING
you to an operating hazard that can cause personnel injury. read the statement below the symbol. The statement is alerting
CAUTION
you to a possibility of analyzer damage or unreliable analysis results.
NOTE
read the statement below the symbol. The statement is alerting you to information that requires your attention.
All the substances (samples, controls, calibrators, reagents and liquid wastes) and areas in contact with these substances are potentially infectious. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when accessing these substances and areas in the laboratory. In the event of main unit leak, the leaking fluid is biohazardous.
WARNING It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or injury of human health. Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g. ethanol) around the analyzer. Otherwise, the risk of explosion may exist. When servicing the analyzer, be sure to turn off the power. Servicing the analyzer when it is on may bring risk of electric shock or damage to electronic components. Please connect the analyzer to a socket having sole fuse and protective switch. Do not use the same fuse and protective switch with other equipment (e.g. life supporting equipment). Otherwise, the equipment failure, over current or impulse current that occurs at the startup moment may lead to tripping. To prevent personal injury during the maintenance, keep your clothes, hairs and hands from the moving parts, such as sample probe, pincher and piercer. Possible mechanical movement of the warned position may lead to personal injury during normal operation, removal and service verification. Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
1-3
Overview
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory. If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION Improper maintenance may damage the analyzer. Maintain the analyzer strictly as instructed by the service manual and inspect the analyzer carefully after the maintenance. For problems not mentioned in the service manual, contact Mindray customer service department for maintenance advice. To prevent personal injury or damage to equipment components, remove metal jewelry before maintaining or servicing electronic components of the equipment. Electrostatic discharge may damage electronic components. If there is a possibility of ESD damage with a procedure, then do that procedure at an ESD workstation, or wear an antistatic wrist strap.
NOTE The operator is required to follow the instructions below this symbol. The instructions will emphasize important information or information that requires particular attention of the operator.
1.6 Symbol Symbols used in this service manual:
Symbol
Meaning The operator is required to follow the instructions below this symbol. Failure to do so may place the operator at a potential risk of biohazard.
WARNING CAUTION
The operator is required to follow the instructions below this symbol. Failure to do so may cause personal injury. The operator is required to follow the instructions below this symbol. Failure to do so may cause malfunction or damage of the product or affect the test results.
1-4
Overview
NOTE
The operator is required to follow the instructions below this symbol. The instructions will emphasize important information or information that requires particular attention of the operator.
The analyzer system may contain the following symbols:
CAUTION Ensure the labels are in good condition and not damaged while servicing the analyzer.
When you see
It means CAUTION, CONSULT ACCOMPANYING DOCUMENTS.
Note: It is recommended that the reader refers to the accompanying documents for important safety information. BIOLOGICAL RISK
WARNING, LASER BEAM
PROTECTIVE EARTH (GROUND)
USB port
Network interface
ALTERNATING CURRENT
FOR IN VITRO DIAGNOSTIC USE
Batch code
1-5
Overview USE BY (YYYY-MM-DD)
Serial number
MEASUREMENT AUTHORIZATION SYMBOL DATE OF MANUFACTURE
Pricking danger
Manufacturer
TEMPERATURE LIMITATION
CONSULT INSTRUCTIONS FOR USE
The device fully complies with requirements of EU IVD Directive 98/79/EC This electronic product contains certain toxic substances, and has an Environmental Protection Use Period (EPUP) of 20 years. It can be used safely during the EPUP, but shall be recycled after the EPUP.
1-6
2 Specifications 2.1. Product Name Name: Auto Hematology Analyzer Model: BC-5150/BC-5000 BC-5150 Appearance
BC-5000 Appearance
2-1
Specifications
2.1.1 Physical Specifications
Height
Depth Width Table 2-1
Dimensions and weight
Overall
BC-5150/BC-5000
Width ≤ 325 mm Height ≤ 435 mm (rubber feet Dimensions included) Depth ≤ 410 mm Weight
≤25Kg
2.1.2 Electrical Specifications Table 2-2
Main unit power supply
Parameter Voltage
Value (100V-240V~) ±10% ≤300VA
Input Power
50/60±1Hz
Frequency
2-2
Specifications
Only fuses of specified specification shall be used. Fuse Specification: 250V
3.15A
D5X20
2.1.3 Environment Requirements Operating environment, storage environment and running environment Table 2-3
Overall environment requirements
Operating Environment
Storage Environment
Running Environment
Requirements
Requirements
Requirements
10℃～30℃
-10℃～40℃
10℃～35℃
20%～85%
10%～90%
10%～90%
70kPa～106kPa
50kPa～106kPa
70kPa～106kPa
Ambient Temperature Relative Humidity Atmospheric Pressure
2.1.4 Specifications Measurement mode Two measurement modes are provided: CBC and CBC+DIFF.
Sample mode Three sample modes are provided: whole blood mode, prediluted mode and Capillary Whole Blood mode. Each of the three sample modes can be used in both CBC and CBC+DIFF measurement mode.
Measurement speed BC-5000's testing speed for OV-WB/OV-PD/OV_PWB modes is not lower than 40 samples per hour. BC-5150's testing speed for OV-WB/OV-PD/OV_PWB modes is not lower than 60 samples per hour.
2.2. Testing Parameters The analyzer provides quantified results for 25 report parameters and 4 research parameters(as shown in the table below), 3 histograms and 1 scattergram, and 2 measurement modes (CBC and CBC+DIFF). Parameter Series
English Name
Abbreviation
2-3
CBC
CBC + DIFF
Specifications
White blood cell parameters (15 items), including 4 research parameters
White Blood Cell count
WBC
√
√
Basophils number
Bas#
/
√
Basophils percentage
Bas%
/
√
Neutrophils number
Neu#
/
√
Neutrophils percentage
Neu%
/
√
Eosinophils number
Eos#
/
√
Eosinophils percentage
Eos%
/
√
Lymphocytes number
Lym#
/
√
Lymphocytes percentage
Lym%
/
√
Monocytes number
Mon#
/
√
Monocytes percentage
Mon%
/
√
Abnormal Lymphocytes
ALY#
/
√
ALY%
/
√
LIC#
/
√
LIC%
/
√
Red Blood Cell count
RBC
√
√
Hemoglobin Concentration
HGB
√
√
Mean Corpuscular Volume
MCV
√
√
Mean Corpuscular
MCH
√
√
MCHC
√
√
RDW-CV
√
√
RDW-SD
√
√
Hematocrit
HCT
√
√
Platelet count
PLT
√
√
Mean Platelet Volume
MPV
√
√
Platelet Distribution Width
PDW
√
√
Plateletcrit
PCT
√
√
Platelet larger cell ratio
P-LCR
√
√
Platelet larger cell count
P-LCC
√
√
number Abnormal Lymphocytes percentage Large Immature Cells number Large Immature Cells percentage
Red blood cell parameters (8 items)
Hemoglobin Mean Corpuscular Hemoglobin Concentration Red Blood Cell Distribution Width - Coefficient of Variation Red Blood Cell Distribution Width - Standard Deviation
Platelet
parameters (6 items)
Histogram English Name
Abbreviation
CBC
CBC + DIFF
White Blood Cell Histogram
WBC Histogram
√
√
Red Blood Cell Histogram
RBC Histogram
√
√
2-4
Specifications Platelet Histogram
PLT Histogram
√
√
Scattergram Name
Differential Scattergram
Abbreviation
CBC
CBC + DIFF
Diff Scattergram
/
√
“√”means available in this measurement mode, and “/”means not available in this measurement mode. ALY%, LIC%, ALY# and LIC# are research parameters which are only intended for research purpose and can not serve as basis for clinical diagnosis. For more information on research parameters, please refer to 5.2.2 General Settings Research Parameters.
2.3. Performance Requirements 2.3.1 Background/Blank Count Background refers to the background count performed automatically by the analyzer during the startup process; its result shall meet the requirements in the following table. The blank count requirements apply to both whole blood and predilute modes. Blank count test method: run diluent on the analyzer for 3 times in a row, the highest value among the 3 results shall meet the requirements in the following table. Table 2-4 Background/blank count requirements
Parameter
Background/blank count requirements ≤ 0.20× 109 / L
WBC RBC
≤ 0.02× 1012/ L
HGB
≤1g/L
HCT
≤ 0.5 %
PLT
≤ 10 × 109 / L
2.3.2 Carryover Carryover refers to the transfer of blood cells from high concentration sample to low concentration sample. Verification method: Prepare a high concentration sample (centrifugated high value control or
2-5
Specifications
special high value linearity control) which is within the range specified in Table 13, mix and then test it for 3 consecutive times, the test results are i1, i2 and i3; prepare a low concentration sample (diluted low value control, dilution ratio: 1:10) which is within the range specified in Table 13, test it for 3 consecutive times, the test results are j1, j2 and j3. Calculate the carryover according to the following equation, the result shall meet the requirements in Table 12.
Table 2-5 Carryover Requirements
Parameter
Carryover
WBC
≤0.5％
RBC
≤0.5％
HGB
≤0.6％
HCT
≤0.5％
PLT
≤1.0％
Table 2-6 Sample Concentration Range of Carryover Test
Parameter
Unit
WBC
×10 /L
RBC HGB HCT PLT
High concentration range > 15.00
9
12
×10 /L g/L 9
×10 /L 9
×10 /L
Low concentration range < 3.00
> 6.00
< 2.00
> 200
< 40
> 54%
<18%
> 300
< 100
2.3.3 Repeatability Test a sample which meets repeatability requirement on the analyzer for 10 consecutive times, calculate the CV(%) and absolute deviation (d) of each parameter, the results shall meet the requirements in the following table.
In the equation:
s ---- standard deviation of sample test results; x ---- mean value of sample test results;
xi ---- actual test result of the sample; d ---- absolute deviation of the sample test results. 2-6
Specifications Table 2-7
Whole Blood Repeatability Requirements
Condition
Parameter
Whole
Blood
Predilute
Repeatability
Repeatability
(CV/absolute
(CV/absolute
deviation d)
deviation d)
9
4.00×10 /L～15.00× 10 / 9
≤2.0％
≤4.0％
WBC L Neu%
50.0％～70.0％
±4.0(d)
±8.0(d)
Lym%
20.0％～40.0％
±3.0(d)
±6.0(d)
Mon%
5.0%～10.0％
±2.0(d)
±4.0(d)
Eos%
2.0％～5.0％
±1.5(d)
±2.5(d)
Bas%
0.5％～1.5％
±0.8(d)
±1.2(d)
3.50 × 1012 / L ~ 6.00 × 1012 /
≤1.5%
≤3.0%
≤1.5%
≤3.0%
≤1.0%
≤2.0%
100 × 10 / L ~ 149 × 10 / L
≤6.0%
≤10.0%
150 × 109 / L ~ 500 × 109 / L
≤4.0%
≤8.0%
/
≤4.0%
≤8.0%
RBC L HGB
110 g/L ~ 180 g/L
MCV
70 fL～120 fL 9
PLT MPV
9
2.3.4 Linearity Range Linearity was determined by running diluted samples. Samples of different concentrations were tested in both whole blood and predilute modes; the slope and intercept were calculated per the linear regression equation, and then the deviation between the theoretical value and test result was obtained, which shall meet the requirements in the following table. Table 2-8 Linearity Requirements
Parameter
WBC
Linearity Range 0.00 × 109/L ～ 100.00
Deviation Range (Whole
Deviation
Blood)
(Predilute)
±0.30×109/L or ±5％
±0.60×109/L or ±6％
±10％
±12％
×109/L (for both BC-5000 and BC-5150) 100.01 × 109/L ～ 500.00×109/L (for BC-5150 only) 2-7
Range
Specifications
RBC
0.00×1012/L～8.00×
±0.05×1012/L or ±5％
±0.10×1012/L or ±10％
1012/L HGB
0 g/L～250g/L
±2g/L or ±2％
±4g/L or ±4％
PLT
0 × 109/L ～ 1000 ×
±10×109/L or ±8％
±20×109/L or ±16％
±12％
±20％
109/L (for both BC-5000 and BC-5150) 1001×109/L ~ 5000× 9
10 /L (for BC-5150 only) HCT
0%~67%
±2% (HCT value)
or
±3% (deviation percent)
±4%(HCTvalue) or
±6%
(deviation percent)
Note: The linearity ranges above are expressed in both absolute deviation and deviation percent, meeting either of the ranges are OK.
2.4. Display Range Table 2-9 Display Range
Parameter
Display Range
WBC
0.00×109/L～999.99×109/L
RBC
0.00×1012/L～18.00×1012/L
HGB
0 g/L～300g/L
PLT
0×109/L～9999×109/L
HCT
0%~80%
2.5. Product Description BC-5150 AUTO HEMATOLOGY ANALYZER composed mainly of analysis unit, information management unit, output unit and accessories. The illustrations in this manual are based on BC-5150. The structures of BC-5000 and BC-5150 are basically the same.
2-8
Specifications
This analyzer is heavy and may cause personal injury if handled by only one person. If necessary, it is recommended to use two person for handling the analyzer. It is important to follow appropriate safety rules and use appropriate tools while handling.
2-9
Figure 2-1 Front view of the main unit
1 ----
[Aspirate] key
2 ---- Sample probe
3 ---- Power/Status indicator
4 ---- Display
2-10
Specifications
Figure 2-2 Back view of the main unit
1 --- M-52D diluent inlet
2 --- Waste outlet
3 --- Waste sensor
4 --- Power input socket
5 --- Power switch
2-11
Specifications
Figure 2-3 Left view of the main unit
1 --- Access door
2 --- Panel Module
3 --- Left door assembly
4 --- Network interface and USB port
Main unit The machine for analysis and data processing is the main part of the product.
Power/Status indicator The Power/Status indicator is located in the middle of the right side of the analyzer (front side). It tells you about the status of the analyzer including ready, running, error, sleep and on/off, etc.
Power switch The power switch is located on the rear side of the main unit. This switch can be used to turn on/off the main unit.
To avoid damage, do not turn on/off the power of the analyzer continually in a short time.
2-12
Specifications
[Aspirate] key The [Aspirate] key is located on the middle of the right front side (the right one). You can press the key to start the selected analysis cycle, dispense diluent or wake up the system from sleep
USB port There are 4 USB ports on the left side of the main unit for peripheral connection or data transmission.
2.6. Product Configuration The system configuration is composed mainly of main analyzer unit, accompanying accessories and reagent system. The user can choose an optional external scanner/printer. The USB port can be used to connect the following printer models: EPSON LQ-590K, HP Laser Jet P1505n, HP Office Jet Pro K5300, and HP LaserJet P1606dn.
2.7. Reagents, Controls and Calibrators As the analyzer, reagents, controls, and calibrators are components of a system, performance of the system depends on the combined integrity of all components. You should only use the Mindray-specified reagents, which are formulated specifically for the fluidic system of your analyzer in order to provide optimal system performance. Do not use the analyzer with reagents from multiple suppliers. In such use, the analyzer may not meet the performance specified in this manual and may provide unreliable results. All references related to reagents in this manual refer to the reagents specifically formulated for this analyzer. Each reagent package must be examined before use. Product integrity may be compromised in packages that have been damaged. Inspect the package for signs of leakage or moisture. If there is evidence of leakage or improper handling, do not use the reagent.
Store and use the reagents as instructed by instructions for use of the reagents. When you have changed the diluent, lyses or cleansers, run a background to see if the results meet the requirement. Pay attention to the expiration dates and open-container stability days of all the reagents. Be sure not to use expired reagents. After installing a new container of reagent, keep it still for a while before use.
2-13
Specifications
2.7.1 Reagents M-52 D DILUENT
Used for diluting the blood samples to achieve functions such as blood cell counting, volume measurement and hemoglobin measurement.
M-52 DIFF LYSE
Used for lysing red blood cells to categorize quartile groups of white blood cells.
M-52 LH LYSE
Used for lysing red blood cells to achieve functions such as white blood cell counting, classification of basophils and hemoglobin measurement.
PROBE CLEANSER
Used for cleansing the instrument regularly.
2.7.2Reagent Consumption Volume Table 2-10 3107 reagent volume
Diluent
Sample Mode
DIFF Lyse (ml)
LH Lyse (ml) Probe cleanser
(ml)
(ml)
CD
27.5
1
0.2
0
CBC
23.2
0
0.2
0
CD
27.5
1
0.2
0
CBC
23.2
0
0.2
0
CD
27.6
1
0.2
0
CBC
22.9
0
0.2
0
Shutdown
60.9
1
0.2
2
Normal Startup
65
1
0.2
0
Exit Standby 1
3.7
0
0
0
Exit Standby 2
16.9
0
0
0
Exit Standby 3
65
3
0.2
0
Whole Blood Mode
Capillary Blood Mode
Prediluted Mode
2-14
Specifications
2.7.3 Controls and Calibrators The controls and calibrators are used for calibration and quality control of the analyzer. The control is an industrial whole blood product, used for monitoring and evaluating the accuracy of the hematology analyzer. They are available in low, normal, and high levels. The control is also an industrial whole blood product, used for the calibration of this analyzer to establish metrological traceability for measurement results. For use and storage of controls and calibrators, please refer to the instructions for use of the controls and calibrators. All references related to controls and calibrators in this manual refer to the controls and calibrators specifically formulated for this analyzer by Mindray.
2.8. Information Storage Capacity 3.
Table 2-11
Data storage requirements
Storage Capacity
BC-5000's storage capacity of sample data is not less than 20000 BC-5150's storage capacity of sample data is not less than 40000
Storage Contents
The storage contents shall include at least the following information: counting results and diagrams (including histograms and scattergrams), sample information, patient information, alarm message, special information of the instrument
2-15
3 Operation Principles 3.1 Overview This analyzer employs Coulter principle to test the number of RBC and PLT, colorimetric method to measure the hemoglobin concentration, and semiconductor laser flow cytometry to obtain differential statistics of white blood cells. The analyzer will calculate the other parameters based on these results.
3.2 Workflow The whole system contains the following main functions: reagent system, sample allocation, sample preparation, sample testing, signal processing, parameter analysis, data management, status monitoring, scheduling control and information processing, human machine interface, power supply, cleaning and maintenance. The relationship between these functions are as shown in the chart below.
The scheduling control and information processing function block controls other function blocks, which collaborate in accordance with the designed processes and requirements to 3-1
Operation Principles
complete the core task of the whole system, i.e. sample measurement and analysis.
3.3 Sample aspiration he analyzer will aspire 15μL (in CBC+DIFF mode) or 11.5μL (in CBC mode) of whole blood sample in the OV-WB mode. In OV-PD mode, the operator shall mix 20 μL of capillary blood sample and 480 μL of diluent outside the analyzer to obtain a diluted sample with the dilution ratio of 1:25, and send this diluted sample to the analyzer. In this event, the analyzer will aspirate 200 μL of diluted sample.
3.4 White Blood Cell Measurement Laser flow cytometry
Figure 3-1 White blood cell measurement
After the blood sample is mixed by the lyse, the red blood cells will be lysed, and the white blood cells will be dyed. Through the sample probe, the dyed fragments of white blood cell and red blood cell are injected into the flow cell, which is filled with the diluent. Wrapped in the sheath fluid formed by the diluent, the cells go through the laser detection zone in rows after a secondary acceleration. When the cells are exposed to laser beam, the scattered light is related to the cell size and the refractive index of both the cell membrane and the internal structure. These scattered light signals are received and converted into electrical pulses by the photodiode. From these electrical pulses, a two-dimensional distribution map of the cell size and internal information and be obtained, which is called a scattergram. From the WBC scattergram and histogram, the white blood cell differential and count can be obtained.
3-2
Operation Principles
3.5 Hemoglobin Concentration Measurement Colorimetric method After the diluted sample is added into the lyse, the red blood cells will lyse and release hemoglobin, which combines the lyse to form hemoglobin complexes. According to the Lambert-Beer's law, with the radiation of LED monochromatic light with a central wave length of 530 nm, it is possible to measure the transmitted light density of the hemoglobin complexes in the solution and background, by which the hemoglobin concentration can be calculated.
Hemoglobin concentration parameters The concentration of hemoglobin (HGB) in g/L can be calculated from the following equation.
Blank Photocurrent HGB(g/L) = Constant × Ln Sample Photocurrent Red blood cell/Platelet measurement
Impedance method This analyzer employs the impedance method to count the RBC/PLT. There is a small opening in the RBC bath, which is called inspection aperture. A pair of electrodes on both sides of the aperture are connected to a constant current power supply. Since the cells are poor conductor of electricity, when the cells in the diluted sample pass through the aperture under a constant negative pressure, the resistance between the electrodes changes to generate a pulse signal across the electrodes, which is proportional to the cell size. The number of the pulses is equal to the number of cells that pass the aperture, and the amplitude of the pulses is proportional to the cell size.
3-3
Operation Principles
Figure 3-2 The counting principle
The collected electric pulses are amplified and then compared with the channel voltage threshold corresponding to the size range of normal red blood cells/platelets, in order to calculate the number of the pulses which amplitude are within the red blood cell/platelet channel. Therefore, the collected electric pulses are classified according to the channel voltage threshold. The numbers of the electric pulses within the red blood cell/platelet channel are the numbers of the red blood cells/platelets. The size distribution of the cells is determined by the numbers of the cells in each channel, which are classified according to the pulse voltage amplitude. The two-dimensional diagram, in which the horizontal axis represents the cell size and the vertical axis represents the relative number of the cells, are the histogram that reflects the distribution of the cell groups.
Time Measurement The basis of time measurement is under certain vacuum pressure and with fixed aperture dimension, the sample volume passes through the aperture within a certain period of time is definite. Thus analysis results can be obtained by calculating sample volume from analysis duration, dilution ratio, etc. And analysis accuracy can be ensured by controlling vacuum generating process and monitoring real-time vacuum pressure and aperture voltage. Monitor and determine clogging: by monitoring aperture and sample particle information, relevant characteristic information is concluded, and the judgment is made in combination with the threshold.
Red blood cell parameters Red blood cell counts 3-4
Operation Principles
RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes passing through the aperture. Mean red blood cell volume Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and expresses the result in fL. Hematocrit, mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows, where the RBC is expressed in 1012/L, MCV in fL and HGB in g/L.
HCT =
RBC × MCV 10
MCH =
HGB RBC
MCHC =
HGB × 100 HCT
where the RBC is in 1012/L, the MCV is in fL, and the HGB is in g/L. The coefficient variation of the red cell distribution width Based on the RBC histogram, this analyzer calculates the CV (Coefficient of Variation, %) of the erythrocyte distribution width. The standard deviation of the red cell distribution width RDW-SD (RBC Distribution Width – Standard Deviation, fL) is obtained by calculating the standard deviation of the red blood cell size distribution.
Platelet parameters Platelet count PLT (109/L) is measured directly by counting the platelets passing through the aperture. Mean platelet volume Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL). Platelet distribution width Platelet distribution width (PDW) is the geometric standard deviation (GSD) of the platelet size distribution. Each PDW result is derived from the platelet histogram data and is reported as 10(GSD). Plateletcrit 3-5
Operation Principles
This analyzer calculates the PCT as follows and express it in ％, where the PLT is expressed in 109/L and the MPV in fL. where the PLT is in 109/L and the MPV is in fL.
3.6 Parameter Flags 3.6.1 Flags The following table lists all 22 flags and their indications. Flag Type
Flag
Meaning
Judgment criterion
Interference of PLT clump or 1. The DIFF and BASO WBC Abnormal
NRBC to WBC count and channels differential may exist:
Immature Cell?
Immature cells or blasts may exist
Many scatter-points in the immature cell area of the scattergram
Abnormal Abn./Atypical Lym?
are
unproportionate.
atypical
lymphocytes lymphocytes
or may
exist.
Many scatter-points in the abnormal/
atypical
lymphocytes area of the scattergram
Leucopenia
Low WBC analysis results
WBC < 2.50×10^9/L
Leucocytosis
High WBC analysis results
WBC > 18.00×10^9/L
Neutropenia
Low
neutrophils
analysis NEUT# < 1.00×10^9/L
results
WBC Neutrophilia Lymphopenia Lymphocytosis Monocytosis Eosinophilia Basophilia
High
neutrophils
analysis NEUT# > 11.00×10^9/L
results Low
lymphocytes
analysis LYMPH# < 0.80×10^9/L
results High
lymphocytes
analysis LYMPH# > 4.00×10^9/L
results High
monocytes
analysis MONO# > 1.50×10^9/L
results High
eosinophils
analysis EO# > 0.70×10^9/L
results High basophils analysis results BASO# > 0.20×10^9/L Wbc < 4.0×10^9/L and Rbc <
Pancytopenia
WBC, RBC and PLT low
3.5×12^9/L and Plt < 100 ×10^9/L
RBC
RBC Histogram Abn.
Possible
presence
microcytes,
3-6
of The
distribution
of
macrocytes, histogram is abnormal
RBC
Operation Principles anisocytosis,
RBC
agglutination
and
dimorphic
histogram HGB HGB Abn./Interfere?
abnormal
or
RBC
agglutination, or interference may exist (e.g., WBC high)
MCHC > 380 g/L or HGB interference
Microcytosis
MCV low
Mcv < 70fL
Macrocytosis
MCV high
Mcv > 110fL
Anemia
Anemia
HGB < 90g/L
Erythrocytosis
RBC high
RBC > 6.5×10^12/L
Possible
presence
PLT Scattergram Abn. microcytes,
red
blood
of cell
debris, giant PLT or PLT clump
The
distribution
of
PLT
scattergram is abnormal
PLT Thrombopenia
PLT low
PLT < 60×10^9/L
Thrombocytosis
PLT high
PLT > 600×10^9/L
3.6.2 Shielding Protocol See the following table for the shielding relations of each flag. Flag Type
Flag
Shielding Relation
WBC Abnormal
R/？Flag parameter: WBC, related DIFF parameters
Immature Cell?
R/？Flag parameter: Neu％#, Mon％#, Bas％#.
Abn./Atypical
R/？Flag parameter: Lym％#, Mon％#, Bas％#, etc. Differ slightly based on the situation.
Lym? Leucopenia
/
Leucocytosis
/
Neutropenia
/
Neutrophilia
/
Lymphopenia
/
Lymphocytosis
/
Monocytosis
/
Eosinophilia
/
Basophilia
/
Pancytopenia
/
WBC
RBC
RBC Histogram Abn.
R/？Flag parameter: RBC, HCT, RDW－CV, RDW－SD, etc. Position of the “?” differs slightly based on the situation.
HGB Abn./Interfere?
R/？Flag parameter: HGB, MCH, MCHC.
Microcytosis
/
Macrocytosis
/ 3-7
Operation Principles Anemia
/
Erythrocytosis
/
PLT Scattergram Abn. R/？Flag parameter: PLT, MPV, PDW, PCT, PLCR, PLCC, etc.
PLT
Thrombopenia
/
Thrombocytosis
/
3.6.3 Sensitivity Adjusting Mechanism The sensitivity adjusting mechanism allows adjustment of flag rate to meet the needs of all hospitals (see “Flag alarm sensitivity” in the Operator’s Manual).
3-8
4 Software and Interface 4.1. Start-up Version Check At startup, the machine will automatically check the software version. If the software version does not match, a window will pop up as shown below:
Figure 4-1The software version match window Please prepare the software upgrade package, select the appropriate language and click the “OK” button. The system will perform the software upgrade progress. Detection of unmatched software version at startup is caused by upgrading individual software component, such as digital version FPGA chip writing software, drive board FPGA writing software, MCU writing software, sequence and system software.
Always use controlled software upgrade package for software upgrade.
4-1
Software and Interface
4.2. Login 4.2.1 Log in using service level username and password Username: "Service" Password: "Se s700"(there is a space between Se and s700).
The login password is case sensitive.
4.2.2 Login Check After login with service level password, the machine will automatically check the board backup data and SD card data. If any board or SD card has been changed, or abnormal shutdown occurs after configuration, a recovery or backup operation of the instrument data will be prompted after login with service level password.
Figure 4-2Login check prompt window Click “OK” to enter the Data Backup and Recovery screen, and perform data backup and recovery according to the prompts.
4-2
Software and Interface
Figure 4-3 Data Backup and Recovery screen 1) If a new SD card is replaced, please follow the subsequent text guide and select “Restore” to restore the important parameters to the SD card. 2) If the MPU is replaced, please follow the subsequent text guide and select “Backup” to back up the data in the new MPU. 3) If abnormal shutdown occurs after configuration has been changed, please select “Backup” to back up the data in the new MPU.
4-3
Software and Interface
4.3. Review 4.3.1 Stability Trend Graph
Figure 4-4 Stability trend graph screen The stability and the limit of the RBC and PLT particles are considered to be 15% of the mean by default; the stability and limit of other particles are considered to be 10% if the mean by default; the limits of the fluids pressure, RBC aperture voltage, HGB voltage and vacuum in the vacuum chamber are considered to be 10% of the mean by default.
The limit can be set manually; the data length is 6 digits; If the limit is larger than the mean, the total low limit is 0.
4-4
Software and Interface
4.3.2 Trend Graph
Figure 4-5 Trend Graph Screen If the mean of the parameter can be gained by calculation of the selected data, then the y-axis of mean central line, upper limit data line, lower limit data line are as follow by default: Mean, Mean + Mean * 10%, Mean – Mean * 10%; If the results of the “Mean+ deviation” do not meet the requirements of the data format of the parameter, then obtain the y-axis of the upper and lower data line by the rounding-off principle. If the limit is larger than the mean, set the low limit as 0; If the upper limit exceeds the parameter display range, click the “OK” button, the “OK” dialog box will prompt”The upper limit exceeds the parameter display range, please reset”.
4.4. Calibration 4.4.1 Calibration Factor and Transfer Factor The purpose of calibration is to obtain accurate blood analysis results. The calibration method is multiplying the result by the calibration factor, so that the final analysis result is close to the target. The calculation equation of the calibration factor is:
4-5
Software and Interface There are two different analysis modes, CBC+DIFF and CBC. The two analysis modes respectively correspond to two fluidics sequence. Therefore, the analysis results of the same sample in different modes are different. However, this difference is relatively fixed. During calibration, it is only required to obtain the calibration factor of one mode. The calibration factor of the other mode can be calculated by multiplying this fixed difference coefficient, which is called the transfer factor. The calculation equation of the transfer factor is:
There are two different sample modes, whole blood mode and prediluted mode, which also correspond to different fluidics sequence. Therefore, different sample modes need to be calibrated separately. The calibration factors can be classified as factory calibration factor and user calibration factor. For the CBC+DIFF mode, the analysis result will be calculated by the following equation: Analysis result=measurement value × factory calibration factor × user calibration factor For the CBC mode, the analysis result will be calculated by the following equation: Analysis result=measurement value × factory calibration factor × transfer factor × user calibration factor The calibration will only generates calibration factors and transfer factors of five traceable parameters: WBC, RBC, HGB, MCV and PLT.
If login with service level password, the calibration will modify the factory calibration factor and transfer factor, and will modify the user calibration factor to 100.00%.
4-6
Software and Interface
4.4.2 Calibration
Figure 4-6Service level calibration screen The service level calibration with calibrators will generate the factory calibration factor and transfer factor at a time. The first 6 counts are performed in CBC+DIFF mode, and the last 6 counts are performed in CBC mode. After all the 12 counts are completed, the new calibration factor and transfer factor will be automatically calculated. The operator will be prompted to save the calibration factor when exiting this screen. Before the calibration, be sure to set up the Calibrator Lot No., the Calibrator Exp. Date, Analysis Mode and Calibration Targets. The range of Calibration factor is [0/75, 1.25]. .
Please use specified calibrators for calibration before their expiration date.
If the calibration factor and CV are beyond the above range, they will be displayed in red, and the current result will not be saved.
4-7
Software and Interface
4.5. Sample Probe Debug The purpose of sample probe debug is to check if the probe can move to each working position properly.
Figure 4-7Sample probe debug screen Enter the sample probe debug screen and click the “Initial position” button. Wait until the initialization is completed before start the sample probe debug. For detailed information, please refer to Section 12.1 “Mechanical position debug” in Chapter 12.
4.6. Temperature Calibration The purpose of temperature calibration is to minimize the difference between the measurement and the actual temperature in order to ensure the accuracy of sample analysis.
4-8
Software and Interface
Figure 4-8Temperature calibration screen There are four quantities in this screen: total difference, new difference, machine measurement value and meter measurement value. This screen does not include one quantity: the actual measurement value, which is the actual temperature measured by the temperature sensor. These quantities satisfy the following equation: New difference = Meter measurement value – Actual measurement value After clicking “Save”, the new difference is assigned to the total difference: Total difference = New difference Machine measurement value = Actual measurement value + Total difference
4.7. Gain Calibration Gain calibration includes gain calibration of the optical channel, the impedance channel and HGB. The purpose of optical channel gain calibration is to ensure the accuracy of the algorithm categorization, and the purpose of impedance channel and HGB gain calibration is to ensure accurate values of MCV and HGB to be calculated. If the scattergram is normal but there is no categorization results or obvious deviation in the categorization results, check the optical system or recalibrate the optical gain. If the HGB background voltage in the status screen is beyond the range, recalibrate the HGB gain.
4-9
Software and Interface
Figure 4-9 Service level calibration screen The optical gain, MCV gain and HGB gain can be calibrated simultaneously in the Gain Calibration screen. As a software gain, the optical gain can be calibrated by mean method. Selecting the “Select” box of the single count to involve this count in the mean calculation. As hardware gains, the MCV gain and the HGB gain can be calibrated by successive approximation, and the “Select” box has no effect on the results of the MCV gain and HGB gain. Whether the gain calibration is successful is marked by color. Unsuccessful calibration result will be displayed in red, which means a recalibration is necessary. If a target has not been set up, then the corresponding gain factor will not be calibrated, as G.S. MCV in the figure above. Note: The G.S. MCV target is not the same as MCV calibration target, they are not the same value. When exiting the Gain Calibration screen, the operator will be prompted whether to save the gain factor.
Only calibration with calibrators is supported in the Gain Calibration screen.
4-10
Software and Interface
Please use specified calibrators for gain calibration before their expiration date. For the targets, please refer to the calibrator target sheet.
4.8. Gain Setting The optical gain, MCV gain and HGB gain can be set up in the Gain Setting screen. The purpose of gain setting and gain calibration is the same. Gain setting can be considered as manual gain calibration.
Figure 4-10 Gain Setting screen The optical gain is a software gain and shall be filled with the gain factor, which can be calculated by the following equation:
The gain factor is a percentage value. The Gain Setting screen allows the gain factor to be set as accurate to two decimal places. The MCV gain and HGB gain are software gains, which require the digital potentiometer to be set. The range of gain setting is [0, 255]. The MCV gain setting can be calculated by the following equation:
4-11
Software and Interface
The HGB gain setting does not need to be calculated by an equation. Just modify the setting until the background voltage is equal to 4.5V.
The gain settings will have effect on the affectivity of the measurement. Please be careful with the setting. While the analyzer is in standby, the HGB voltage will not reflect the background voltage. In this event, the operator must exit the standby mode before adjusting the HGB gain.
4.9. Performance 4.9.1 Background test
Figure 4-11 Background Count screen In the Background Count screen, pressing the aspirate key without using any sample will start the background count. In the Background Count screen, if “pass” is displayed in the Result column,
4-12
Software and Interface then the background test is passed.
4.9.2 Reproducibility
Figure 4-12 Reproducibility Test screen Select the samples that satisfy the reproducibility range and perform 10 consecutive measurements on the analyzer. Calculate the CV (%) or absolute deviation d of each measured parameter and check if the reproducibility requirement is met.
Normal controls are usually used for reproducibility application at the client end.
4-13
Software and Interface
4.9.3 Carryover
Figure 4-13 Carryover Test screen
Test method: Under the stable condition of the analyzer, perform three consecutive measurements on the high-level sample immediately followed by three consecutive measurements on the low- level sample. The carryover can be calculated from the following equation: Carryover (%) =
First low - level sample result－Third low - level sample result × 100％ Third high - level sample result－Third low - level sample result
Advanced Toolbox
4.9.4 Reference range of normal samples Parameter NEU_LAS_P NEU_MAS_P NEU_WAS_P NEU_EQWIDTH_P NEU_LAS_CV(%) NEU_MAS_CV(%) NEU_WAS_CV(%) NEU_EQWIDTH_CV(%)
Mean 139.91 123.87 39.40 14.57 6.83 12.95 20.88 1.12 4-14
Deviation Range 6.01 9.84 4.80 0.30 3.15 2.35 2.35 0.65
Software and Interface
4.10. Advance Toolbox 4.10.1 System Configuration
Figure 4-14System Configuration screen In the System Configuration tab of the advanced toolbox, you can modify the language type, the analyzer serial No. and data type to be saved. After the “Save inf file” option is selected, the inf file will be saved to directory /mnt/hd/soft/dat/rawdata. The inf files save the analyzer status and sample analysis data for diagnostics of analyzer performance. After the “Save raw data” option is selected, the dat file will be saved to directory /mnt/hd/soft/dat/dat. The dat files save the raw pulse signals collected by the MPU FPGA for diagnostics of analyzer performance.
The modification to language type will not take effect until after the analyzer is restarted. The saved inf files and raw data files will occupy relatively large amounts of disk (SD card) space. 4-15
Software and Interface
At most 500 inf files can be saved. After 500 files are saved, the new files will overwrite the old files.
4.10.2 One-key Export
Figure 4-15One-key Export screen The contents that can be exported by One-Key operation include: Inf files Special information files Analyzer information: includes version information, configuration parameter (gain and calibration), algorithm parameters, analyzer status, software language and analyzer name Software debug information: includes parameter setting, error log, upgrade log and system log. Closed-reagent information: includes closed-reagent information and counter information
The USB flash drive has been pre-formatted as FAT32. The following USB drive models are recommended: Kingston 8/16G, SanDisk 8/16G, 4-16
Software and Interface
Maxell 4/8G. There is enough free space in the USB drive. It is recommended to reserve 4G space.
4.11. Software Update Create an upgrade USB drive Unzip update.rar and copy the unzipped “update” directory to the root directory of the USB drive.
The USB flash drive has been pre-formatted as FAT32. The directory structure of USB drive: the root directory contains a directory named update, which contains two directories: step1 and step2.
Upgrade Insert the USB drive into the USB port on the analyzer. Enter the Advanced Toolbox and launch Upgrade to upgrade the software according to the prompts. The upgrade process can be divided into two steps. Step 1: upgrade the guidance and operation system, Step 2: upgrade the software components. When upgrading the boot and operation system, the operator will be prompted to restart the analyzer between step 1 and step 2. When upgrading the software components, the upgrade process will directly go to step 2.
Never disconnect the USB drive or the power supply during the upgrade process. Otherwise the analyzer may not be able to start.
The duration of the upgrade process varies with the upgrade contents. Typically it will last for around 10 minutes. Interaction is needed during the process. Please do not leave when upgrading the analyzer.
4-17
Software and Interface Troubleshooting If the upgrade fails, try again.
4.12. Status Indicator The system status is indicated by the three color indicator on the panel door. All the flash cycles are 2 seconds. The indicator changes with the analyzer status as shown in the table below: Table 4-1 Indication of the main unit status indicator
Analyzer Status
Indicator
Comments
Ready
Green light on
Sequence is allowed
Running
Green light flashing
Sequence is being performed
Running with error
Red light flashing
An error is present and the system is running
Stop with fault
Red light on
An error occurs and the system is not running
No fault is present, but
Yellow light on
Initialization and standby
fluidics action is not
status of sequence is not
allowed
involved in the startup process
Enter/Exit standby
Yellow light flashing
Enter/Exit standby status
status
4.13. Buzzer When an error occurs, the buzzer will beep. The alarm will be automatically cleared by tapping the touchscreen or correcting the error. The buzzer alarm will stop when all the error are cleared. It prompts to instruct the user with possible actions by the beep.
Table 4-2 Main unit buzzer prompts Event
Buzzer
Comments
Prompts Startup completed
One short beep
Startup completed means the whole startup process has been completed and the analyzer is ready for operation
Open-vial aspiration completed
Two short beeps
When count operation can not be
One long beep
4-18
If these screens have already
Software and Interface
started in count related screens
prompted, then the buzzer need
(including Sample Analysis, QC,
not be responded again.
Calibration, Reproducibility, Carryover, Background, Aging and Optical Gain Calibration Count, etc.), press the aspirate key Error
Analyzer is ready
Long intermittent
Tap the touchscreen to stop the
beeps
buzzer
One short beep
Analyzer enters ready status from other status
When the screen is black prompting
Silence
“Please power off the analyzer”
If an error occurs during the shutdown process, the buzzer will beeping when the screen is black
4-19
5 Data Transmission 5.1. LIS Connection Communication setup (“Menu”>“Setup”>“System Setup”>“Communication Setup”)
The operator can perform the following setups in the “Communication Setup” screen Protocol setup Transmission mode
Figure 5-1 Communication Setup screen Protocol setup
IP address: The IP address setting of the analyzer defaulted as 10.0.0.2 Subnet mask: The subnet mask of the analyzer. A typical subnet mask is 255.255.255.0 Default gateway: IP address of the gateway. Mac address: The Mac address of the analyzer, given by the factory. Can not be changed. Comm. Protocol: For selecting the protocol type. Click the pull-down list and select the appropriate communication protocol type from the options. 5-1
Data Transmission
ACK synchronous transmission: This function can be activated by selecting the “ACK synchronous transmission” checkbox. When this function is active, the ACK overtime is defaulted as “10” seconds. The operator can adjust this value in the edit box.
The IP address of the analyzer is statically allocated. Before setup, please consult your network administrator to avoid IP conflict. For communication across subnets, the subnet mask and the gateway must be correct. Please consult your network administrator.
Transmission mode
The operator can select required options by clicking the following checkboxes to activate corresponding communication setup as needed: Auto retransmit The “Auto retransmit” can only be selected when the “ACK synchronous transmission” is selected, if ACK is not selected after overtime, the software will transmitted the content that has transmitted before automatically. Auto communication If it is selected, the software will transmit the sample information and count result to the LIS automatically after the sample analysis. Transmit as print bitmap data If it is selected, the scattergram and histogram that transmitted to the LIS are the same as the print graph, whose background are white. Transmission method for histograms and scattergrams
Click the pulldown list and select the transmission method for histograms and scattergrams as required from the following options: Not transmitted If it is selected, the graphic and image data will not be transmitted. Bitmap If it is selected, the image data will be transmitted, all the scattergram and histogram of the LIS received are bitmap. Data If it is selected, the graph data will be transmitted during the transmission, the scattergram and histogram that LIS received is the data, the data format is customized; it can only be viewed by the Mindray data management software.
5-2
Data Transmission
5.2. Data Management Software Setup Communication parameter setup
Figure 5-2 Communication Parameter Setup screen for data management software
As illustrated above, IP Address refers to the analyzer IP address, Port is fixed as 5100, and Protocol shall match the analyzer configuration. Communication instrument management
5-3
Data Transmission
Figure 5-3 Communication Instrument Management screen for data management software The analyzer is the server, and the LIS and data management software is the client. The connection needs to be initiated by the client.
5.3. Communication Error Analysis 5.3.1 Physical Connection Check if the network cable works properly and if the physical network connections are correct.
5.3.2 Communication Setup Check if the network setup is correct, including the communication setup of the analyzer and LIS.
5.3.3 Network Firewall Please open the network connection license of LIS and data management software, and open the network connection license of port 5100 to check for the firewall.
5-4
6 Optical System 6.1. Introduction to the Principles of Optical System 6.1.1 Operation Principles The basic principle of optical system is the employment of flow cytometry-based laser scattering method. As shown in Figure 6-1, wrapped in the diluent sheath, the processed and diluted blood forms a sample stream carrying cells. This sample stream becomes very thin due to the focusing effect of the sheath, forcing the cells to flow one by one through the center of the chamber with a certain space between each other. Elongated elliptical Gaussian beam goes through the optical zone of the flow cell, irradiates individual cells to generate scattered light, which is received by the detector and transformed into photoelectric signals necessary for cell counting and categorizing.
Figure 6-1 Laser scatter principle Since the sample stream has a certain width, different cells will pass the beam zone at slightly different positions. In order to ensure the consistency of cell scatter signals, the Gaussian beam shall has a certain width in the direction perpendicular to the cell movement to minimize the density variation of the beam coving the sample stream, as shown in Figure 6-1. Meanwhile, in order to prevent the beam from radiating several cells at the same time, the beam shall be small enough in the direction of the cell movement, just being able to cover the entire cell. Therefore, the beam used for radiating the sample stream shall be an elongated elliptical beam.
6-1
Optical System
6.1.2 Beam Path of the Optical system As a component of the optical path, the optical zone of the flow cell is the zone that the laser beam passes which are shown as follows:
Light source assembly: Beam shaping function component, which shapes the divergent elliptical beam generated by the semiconductor laser to elongated beam and directs it into the flow cell. Flow cell assembly: Both an optical component and a fluidic component. As the fluidic interface of the optical system, it provides stable sample streams. The optical performance of this component is also critical. Dirt, contamination or dust in the optical zone on the inside and outside surface of the flow cell may have great impact on the performance of the optical system. Scattering detection assembly: consists of aperture and photoelectric sensor. Used for collecting the scattered light generated by the cells. There are three photoelectric sensors in the optical system for collecting scattered light of three angle ranges, including Low Angle Scatter (LAS), Medium Angle Scatter (MAS) and Wide Angle Scatter (WAS).
Figure 6-2 Optical path diagram of the optical system The relative positional relationship between the three parts of the optical path is achieved by precise commissioning and fastening with special instruments, and therefore is not field serviceable.
6.2. Physical Structure 6.2.1 Overall Structure The overall structure of the optical system is shown in Figure 6-3. According to different functions, the system can be divided into the following parts:
6-2
Optical System
Figure 6-3 Overall structure model of the optical system
1 ---Light source assembly
2 ---Flow cell assembly
3 ---Substrate assembly
4 ---Preamplifier and shield shell
5 ---Shield assembly
6 ---Scattering detection assembly
7 ---Laser control board
Figure 6-4 Physical structure of the optical system
6-3
Optical System
6.2.2 Light Source Assembly The light source assembly is used for providing light source output and beam shaping for the optical system, as shown in Figure 6-5. Both the removal of internal parts of the light source assembly and the removal of the assembly from the substrate are forbidden. Generally, if the light source assembly is determined to be faulty, the whole optical system shall be replaced.
Figure 6-5 Light source assembly
6.2.3 Flow Cell Assembly The flow cell assembly is the fluidic interface of the optical system. The fluidics are turned into stable sheath stream under the pressure of the shield fluid bath. After reaction, the cells are injected by the sample syringe into the flow cell assembly and are wrapped by the sheath. Then the cells go through the flow cell one by one for laser irradiation, as shown in Figure 6-6.
(a) Physical view of the flow cell assembly
(b) Operation principle of the flow cell
6-4
Optical System Figure 6-6 Flow cell assembly Both the removal of internal parts of the flow cell assembly and the removal of the assembly from the substrate are forbidden. Generally, if the flow cell assembly is determined to be faulty, the whole optical system shall be replaced.
6.2.4 Optical Substrate Assembly The substrate assembly provides support, fixation and shock absorption for the optical system, as shown in Figure 6-7. The screws in the substrate assembly is not removable. If loose screws result in abnormal condition of the optical system, please replace the whole optical system.
Figure 6-7 Optical substrate assembly
6.2.5 Preamplifier and Shield Shell The preamplifier and shield shell are used for pre-amplifying the optical system signals and shielding signal noise. The preamplifier is connected by the preamplifier shield shell with the optical system shield shell. If the preamplifier is determined to be faulty, it is possible to remove and replace it from the optical system, as shown in Figure 6-8.
6-5
Optical System
Figure 6-8 Preamplifier and shield shell
6.2.6 Shield Shell Assembly The shield shell is used for isolating the optical system from the outside to avoid interference of dust, stray light and electromagnetic noise, and for connecting the optical system to the analyzer, as shown in Figure 6-9.
Figure 6-9 Shield shell assembly
6.2.7 Scattering Detection Assembly As the detection unit of the optical system, the scattering detection assembly consists of medium/small angle PD and large angle PD and corresponding medium/small angle aperture and 6-6
Optical System large angle aperture and support structure. The 3D model and physical view are shown in Figure 6-10. The scattering assembly is a whole unit and can not be removed from the optical substrate, although the large angle PD assembly is removable. When the scattering detection assembly is determined to be faulty, it is necessary to replace the whole optical system.
Figure 6-10 Scattering detection assembly
6.2.8 Laser Control Board The laser control board is used for providing stable driving current for the laser to keep a full and stable laser output power, as shown in Figure 6-11. If the laser control board is determined to be faulty, it is possible to remove and replace it from the optical system.
Figure 6-11 Las
6.3. Determinating the Optical System Status When abnormal sample scattergram causes failed or incorrect categorization, and the reagent and fluidic connections are determined to be normal, it will be necessary to check the optical system status. In this section, the optical system status is tested with standard particles. Prior to the test, prepare the following items: Consumables: 4k-07 Std. part. (7µm) and 1.5 mL centrifuge tube, slobe cleanser. The detailed procedure is as follows.
1.
First, add 0.5 mL of deionized water to a 1.5mL centrifuge tube. Shake the 7 μm std. 6-7
Optical System
part. bottle until the solution is well mixed, then add 3 drops of the solution in to the 1.5mL centrifuge tube. Cap the tube and shake it until this solution become well mixed, as shown in Figure 6-12.
Figure 6-12 Preparation of the 7µm std. part. solution
2.
3.
Select the Maintenance menu and enter the “Optical” screen. Perform counting with the prepared std. part. solution. After the counting is completed, the result will be automatically displayed in the screen, as shown in Figure 6-13. Determine the optical system status by the parameter Particle 1 according to the counting result. The optical system is OK if all the following requirements are met: Parameter
Total
LAS MAS WAS 4.
1500~3000
CG Position
CV
38~45
≤6.50
100~158
≤3.00
100~200
≤8.00
Generally, if the parameters fail to meet the requirements, it may be caused by a dirty flow cell. The built-in maintenance program can be used to solve this problem. The method is as follows: click the “Maintenance-->Maintenance” menu and select “Flow Cell Cleaning” in the “Cleaning” screen. The machine will automatically complete the cleaning operation (in about 1 minute).
After the maintenance, repeat step 2 and 3 and check if the result meets the requirements. If not, probe cleanser should be used to clean the flow cell: click the “Maintenance-->Maintenance” menu and select “Overall Soak” in the “Maintenance” screen, and carry out the operation of the program. After the maintenance above, repeat step 2 and 3 again, and check if the result meets the requirements. If still not, the manual maintenance is required. For details, please see the next chapter.
6-8
Optical System
Figure 6-13 Optical screen of the stanadard particle
6.4. Maintenance and Replacement of the Optical System When the optical system is determined as abnormal according to Section 6.3, and can not be restored by automatic maintenance, then manual maintenance will be necessary. Furthermore, if the optical system is determined as normal according to Section 6.3, but the scattergram or categorization of the blood sample is abnormal, then other problems except the optical system shall be taken into account. Before performing maintenance and replacement on the optical system, prepare the following items: Tools: A crosshead screwdriver and an allen wrench set. Consumables: 4k-07 Std. part. (7µm), 1.5 mL centrifuge tube, microfiber clean cloth, dehydrated alcohol and probe cleanser.
6.4.1 Maintenance of the Optical System Before maintenance of the optical system, it is necessary to open the top cover of the optical system shield shell. As shown in Figure 14, use a crosshead screwdriver to remove the locking screw. Open the top cover carefully to reveal the internal structure of the optical system, as shown in Figure 6-4. 6-9
Optical System Tap "Status" > "Voltage&Current" in the menu to enter the Voltage&Current screen, the laser will illuminate automatically.
Figure 6-14 Location of the screws on the shield shell Precautions before proceeding to the next step are as follows: Never look directly into the laser with eyes or through an optical instrument; During test of optical system with the top cover open, please shelter the optical system to prevent bright environmental light from irradiating the detector inside the optical system. Generally, the following steps can be followed to determine which part needs to be maintained. 1.
Check if the wires are firmly connected inside the optical system and if the optical path is blocked by wires.
2.
Check if the output spot is normal. Place a small piece of white paper near the output exit and observe the light spot. The ideal spot shape is a vertical ellipse which is clipped at both top and bottom, as shown in the left in Figure 6-15. The actual spot is shown in the right in Figure 6-15 with a faint halo around it.
6-10
Optical System
Figure 6-15 Light spot at the output exit Abnormal spots can be different, including dark spot, spot clustered into a dot, spot with dark lines, spot with a scattered halo, seriously damaged spot, spot with multiple dark dots in the center, as shown in Figure 6-16.
Figure 6-16 Example of abnormal output spots Abnormal light spots are usually caused by damage or contamination of the laser control board, the laser or the lens in the light source assembly. Missing parts, dark lines or dark dots in the spot are usually caused by contaminated lens in the light source assembly. A clean cloth dampened with dehydrated alcohol may be used to wipe the lens gently, spiraling outward from the center. Be careful not to touch the interior of the lens barrel. If the light spot disappears, darkens or diverges, then the laser control board may be damaged. After the problem is determined, replace the laser control board (be aware of electrostatic) separately and adjust the variable resistor on the board. Perform a std. part. test in accordance with 6.3 to ensure the std. part. indicators to meet the requirements. After replacement, a gain calibration in accordance with Section 4.6 as well as a calibration in accordance with Section 4.3 shall be performed on the optical system. 6-11
Optical System If the light spot disappears, converges, darkens or diverges, and the laser control board is determined to be in good condition, then the laser could have been burned. Since the light source assembly can not be replaced separately, it will be necessary to replace the optical system. 3.
Observe the light spots on the surface and inside the flow cell from the following angles, as shown in Figure 6-17. If the exterior of the flow cell is very bright, then the exterior may be stained. Use a clean cloth dampened with dehydrated alcohol to wipe the exterior, until the bright part darkens or disappears, as shown in the right in Figure 6-17. If the interior of the flow cell is very bright and can not be darkened by the built-in cleaning procedure, then it will be necessary to manually rinse the inside of the flow cell.
Figure 6-17 Flow cell before and after cleansing The cleansing procedure is as follows: Prepare a syringe with a 100 mm long Teflon tube, a 200 mm long Teflon tube and probe cleanser, as shown in Figure 6-18. Shutdown the analyzer, remove the tubes at the waste outlet and the sheath inlet of the flow cell. Connect the syringe to the waste outlet. Connect one end of the other Teflon tube to the sheath inlet, and put another end into the probe cleanser. Draw the probe cleanser with the syringe until the probe cleanser enters the syringe. At this time, the flow cell will be filled with the probe cleanser. After soaking for about 10 minutes, use clean water instead of the cleanser. Draw the syringe forcefully for 2 to 3 times, until the bright spots in the flow cell darken or disappear. Connect the optical path and the tubes and verify the connection, and then turn on the analyzer power.
6-12
Optical System
Figure 6-18 Preparation before cleaning the flow cell interior 4.
Check if the output light is perpendicular to the flow cell. Place an inner hexagon spanner at the output exit. The output spot and the spot reflected by the flow cell shall appear simultaneously and strictly coincide with each other, as shown in Figure 6-19.
Figure 6-19 Output spot and reflection spot After the maintenance is completed, verify if the optical system is working correctly in accordance with the steps in Section 6.3: If the std. part. CV meets the requirement, but the CG position is too low or too high, slightly adjust the variable resistor on the laser control board as shown in Figure 6-11, until the CG position meets the requirement. After maintenance according to this procedure, a gain calibration in accordance with Section 4.6 as well as a calibration in accordance with Section 4.3 shall be performed on the optical system. If the CG position meets the requirement but the CV doesn't, then the maintenance is not qualified. Perform another check and maintenance in accordance with this section. If the CG position and the CV can not meet the requirements after the maintenance, then it will be necessary to replace the optical system.
6-13
Optical System
6.4.2 Replacement of the Optical System If the problem is not solved after maintenance, or if the problem is not serviceable, then it is necessary to replace the optical system with a new one. The replacement procedure is as follows: 1.
Power off the analyzer.
2.
First, gently disconnect the waste outlet tube from the optical system, and connect to a syringe. Disconnect other tubes, aspirate remaining fluid with the syringe from the system. Unscrew the screws and disconnect the signal line from the optical system, as shown in Figure 6-20. Note: Follow the procedure and prevent the corrosive fluid from falling onto the frame!
Figure 6-20 Remove the optical system 3.
Remove the optical system carefully and short the tubes of the optical system in accordance with Figure 6-21.
6-14
Optical System
Figure 6-21 Short the tubes of the optical system together 4.
Install the new optical system into the analyzer. Connect the signal wires, fluidics and optical path. Turn on the analyzer and verify the status of the new system in accordance with the steps in Section 6.3. Note: The fluidic interfaces of the optical system are very fragile. Be careful to avoid knocking them when connecting the tubes during installation!
5.
Perform a gain calibration in accordance with Section 4.6 as well as a calibration in accordance with Section 4.3 on the optical system.
6-15
7 Fluidics 7.1. Measurement Flow The fluidics of the analyzer can be divided into two measurement channels: WBC&HGB Channel RBC&PLT Channel The system flowchart of the WB-CBC+DIFF mode is shown below (DIFF lyse and DIFF sample configuration & measurement are not available in CBC mode):
Figure 7-1Fluidics flowchart (WB-CD mode)
7-1
Fluidics
The system flowchart of the PD-CBC+DIFF mode is shown below (DIFF lyse and DIFF sample configuration & measurement are not available in CBC mode):
Figure 7-2Fluidics flowchart (PD-CD mode)
7.1.1 WBC&HGB Channel DIFF Measurement Reagents: 7-2
Fluidics
DIFF reagent: used for lysis of red blood cells and specialization of different white blood cells; Diluent: background solution used for providing sheath fluid and cleansing Measurement principle: flow cytometry and laser scatter Measurement parameters: MONO#, MONO%, LYMPH#, LYMPH %, NEUT#, NEUT%, EOS#, EOS% Graphics: 4 Differential scattergram Dilution ratio: 1:105.8 Counting duration: 9.1 s Counting flow: 0.008575417ml/s Counting volume: the flow of the sample stream is constant, which can be converted to counting volume by controlling the counting duration Function description: Mix 15 µL of blood sample and 550 µL of diluent in the WBC bath. After the secondary aspiration, add 1 mL of DIFF lyse. After the reaction has been on for a certain time, place the prepared sample at the bottom end of the flow cell. The sample will be wrapped by a sheath stream generated by the large volume syringe of the syringe linkage and be pushed by the small volume syringe into the flow cell for the measurement.
WBC Count and BASO Measurement Reagents:
LH lyse: used for lysing red blood cells and platelets and separating the basophiles by volume from the other white blood cells Diluent: used for providing sheath fluid and cleansing Measurement principle: flow cytometry and laser scatter Measurement parameters: WBC, BASO# and BASO% Graphics: WBC histogram Dilution ratio: 1:123.8*
1
Counting duration: 11.5 s Counting flow: 0.008575417ml/s Counting volume: the flow of the sample stream is constant, which can be converted to counting volume by controlling the counting duration Function description: After DIFF reaction, add 200 µL of LH reagent to the sample. After adequate reaction, place the prepared sample at the bottom end of the flow cell. The sample will be wrapped by a sheath stream generated by the large volume syringe of the syringe linkage and be pushed by the small volume syringe into the flow cell for the measurement.
∗1
Dilution ratio refers to the Dilution ratio in the whole blood mode.
7-3
Fluidics
HGB Count Reagents:
Diluent: used for diluting and cleansing LH lyse: used for lysing red blood cells and combining hemoglobin Measurement principle: colorimetric method Measurement parameters: HGB Dilution ratio: 1:123.8
Function description: The measurement principle of HGB channel is the colorimetric method, which obtains HGB concentration by comparing the transmitted light intensity between background and blood.
7.1.2 RBC/PLT Channel Reagents:
Diluent: used for diluting, cleansing and equal volume processing conductive environment and cells Measurement principle: impedance method Measurement parameters: RBC and PLT Graphics: RBC histogram and PLT histogram Dilution ratio: 1:7533.3 Counting duration: 9 s Counting pressure: -30kpa Measurement volume: The measurement volume is controlled by controlling the vacuum and counting duration. Keep a stable vacuum to ensure a stable flow out of the aperture. The measurement volume can be calculated by controlling the counting duration Function description: Aspirate 21.6 µL of sample (dilution ratio 1:69.75) with the sample probe from the WBC bath. Move the probe to the RBC bath and mix this sample with 2.4 mL of diluent to prepare a sample with dilution ratio of 1:7533.3. After mixing, aspirate the sample with negative pressure in the vacuum chamber through the aperture into the secondary bath. The cells will be measured while passing through the aperture.
7.2. Sample Volume Table 7-1 Sample volume
Item
Whole
Capillary
Prediluted Mode
7-4
Fluidics
Blood
Blood Mode
Mode CBC+DIFF
15µL
15µL
CBC
11.7µL
11.7µL
Dilution outside the analyzer: 20µL of blood sample; 480 µL of diluent, 200µL aspirated Dilution outside the analyzer: 20µL of blood sample; 480 µL of diluent, 200µL aspirated
7.3. Temperature of Fluidics Table 7-2 Temperature of Fluidics
preheat bath
Item
Optical system
Diluent
Target Temperature/ ℃
Varies with the diluent temperature
/
/
Alarm Temperature/ ℃
＜target temperature -1.5, ＞target temperature +3
＞40
＜10, ＞40
7.4. Reagent Consumption Volume Table 7-3 3107 reagent volume
Diluent
Sample Mode
DIFF Lyse (ml)
LH Lyse (ml) Probe cleanser
(ml)
(ml)
CD
27.5
1
0.2
0
CBC
23.2
0
0.2
0
CD
27.5
1
0.2
0
CBC
23.2
0
0.2
0
CD
27.6
1
0.2
0
CBC
22.9
0
0.2
0
Shutdown
60.9
1
0.2
2
Normal Startup
65
1
0.2
0
Exit Standby 1
3.7
0
0
0
Exit Standby 2
16.9
0
0
0
Exit Standby 3
65
3
0.2
0
Whole Blood Mode
Capillary Blood Mode
Prediluted Mode
7-5
Fluidics
7.5. Introduction to Fluidic Parts A brief introduction to the fluidic parts and their respective functions is provided in this section. The symbols mentioned below refer to the symbols in the fluidics diagram.
7.5.1 Mindray Valves Symbol: 2-way valve
3-way valve
Appearance: 2-way valve
3-way valve
Spring pole Function: 2-way valve: to build up or cut off a passage. When power off, the passage from the inlet of the valve to outlet is cut off; when power on, the passage is build up. 3-way valve: to switch among passages. When power off, the public end and the NO (normally open) end are connected; when power on, the public end and the N.O.(normally open) end are connected. Note: the operating voltage of Mindray valves is 12V, and maximal bearable pressure is 200KPa. The internal movement of the valves is driven by electromagnet and the restoration is driven by the spring, so it is recommended not put the valves power-on for too long. When the electromagnet valve is working, the spring pole will lower down, and it will rise to the initial position when power off. You can touch the spring pole and feel the descending or ascending, in order to determine whether it is in action.
7.5.2 2-way Mindray Pressure-proof Valve Symbol Same as the 2-way Mindray valve. Appearance
7-6
Fluidics
Function: Compared with regular 2-way Mindray valve, the 2-way Mindray pressure-proof valve can endure higher reverse pressure. The operation principle of the 2-way Mindray pressure-proof valve is the same with that of regular 2-way Mindray valve. Note: When replacing the valves, please note the distinction between regular 2-way valves and pressure-proof valves. SV03 in Liquid Flow Diagram is a 2-way pressure-proof valve.
7.5.3 LVM Fluidic Valve Symbol Same as the Mindray valves. Appearance 3-way LVM fluidic valve
Function: Same as the Mindray valves. Compared with 2-way Mindray valves, this valve provides higher pressure resistance and smaller pump volume for preciser flow control and broader range of temperature and pressure. Note: the maximal bearable pressure of the LVM fluidic valve is 200KPa, and the CV of the flow is about 0.03. SV11 in the fluidics diagram is a LVM fluidic valve.
7.5.4 Pinch Valve Symbol:
7-7
Fluidics
Appearance:
Function: A clamp-on type valve switched by electromagnetic force. Used for switching the fluid flow.
7.5.5 Liquid Filter Symbol:
Appearance: LF
7-8
Fluidics
Function: Used for filtering the impurities in the diluent.
7.5.6 Syringe Linkage Symbol: SR
Appearance: N/A Function: Composed of a large volume syringe and a small volume syringe, the syringe linkage is driven by a motor and a linkage. The parameter and the function of the syringe linkage are shown in the table below: Table 7-4 Parameter and function list of the syringe linkage
Name
Specific
Function
ation
Used for quantitative aspiration, distribution Small volume syringe
Full scale 250µL
and secondary aspiration of blood samples, and for injecting the sample into the flow cell for measurement Used for quantitative addition of diluent to
Large volume syringe
Full scale 10mL
WBC and RBC bath, wipe fluid supply, cleaning of interior and exterior of sample probe and reaction bath, forcing the sheath into the flow cell, cleaning of the flow cell and sample preparation.
7.5.7 Electromagnetic Metering Pump Symbol
7-9
Fluidics
DP1, DP2 Appearance:
Function: DP1: 1mL volume. Used for addition of DIFF reagent DP2: 200µL volume. Used for addition of LH reagent
7.5.8 preheat bath Symbol
preheat Bath Appearance:
7-10
Fluidics
Function: Used for heating DIFF reagents to ensure the temperature of DIFF reaction.
7.5.9 Vacuum Pump Symbol
Appearance:
Function: LP: Used for draining the wipe, WBC bath, RBC bath and vacuum chamber, and for creating vacuum in the vacuum chamber
7-11
Fluidics
7.5.10 Sample Probe Symbol
Appearance: Open-vial sample probe
Function: Used for providing a rigid cavity with resistance to blood sample corrosion, which can sample and dispense the blood as well as aspirate and dispense probe cleanser. Note: the sample probe is flat-tipped with a side opening to ensure normal aspiration in case that the tip touches the bottom of the sample tube.
7.5.11 Probe Wipes Symbol:
7-12
Fluidics
Appearance:
Open-vial probe wipe Function: Provide a cavity for cleaning open-vial probe or piercing probe by liquid flow and collecting waste fluids on the interior or exterior.
7.5.12 Hydraulic pressure sensor Symbol:
Appearance:
Function: Used for monitoring the fluid pressure. When the pressure is obviously abnormal or beyond the setting range, the sensor will send an alarm signal. 7-13
Fluidics
7.5.13 1-way Valve Symbol:
Appearance:
Function: Used for controlling the flow direction of the DIFF tube to prevent reverse aspiration
7.5.14 Baths WBC bath: Used for providing a place for WBC sample reactions and supplying well reacted DIFF and BASO samples, and for HGB measurement. RBC bath: Composed of primary bath, secondary bath and aperture. Used for providing a place for RBC sample reactions and for RBC/PLT measurement. Vacuum chamber: Used for creating and keeping a stable negative pressure for RBC impedance count. preheat bath: Used for heating DIFF reagents to ensure the temperature of DIFF reaction. WBC isolation chamber: Provide a gas chamber to block interference signals from outside RBC isolation chamber: Provide a gas chamber to block interference signals from outside
7.6. Detailed Introduction of Fluidic Structure The fluidic structure diagram is shown as follows: Please refer to Appendix A.
7-14
Fluidics
7.6.1 Sampling and dispensing channel The structure of sampling and dispensing channel is shown below:
1.
2.
3.
Main function: Aspirate and dispense samples. Aspirate 15 μL of blood sample by conjunctive use of small volume syringe of the syringe linkage (SR) and the sample probe (SPB), and dispense the blood sample. Clean the interior and exterior of the sample probe. The interior is cleaned by the collaboration of the large volume syringe of the syringe linkage and SV03 and 11 valves. The exterior is cleaned by the diluent which is forced by the large volume syringe through SV08, SV07, secondary RBC bath and SV09 into the wipe, with waste fluid recovered by probe wipe, vacuum chamber and waste pump. Aspirate and dispense probe cleanser. During the aspiration, the SV03 is energized. 2mL of probe cleanser will be aspirated by the SR from the SPB and stored mainly in the cleanser tanks (T7 and T8). During the dispensation, the SPB is transported by the sampling assembly to the RBC bath and WBC bath, and the SV03 is kept energized. A certain volume of probe cleanser in the SPB will be dispensed by the SR to the reaction baths.
7.6.2 WBC&HGB Channel Part of the fluidic structure is shown as follows: The blue lines are diluent flows; red lines are DIFF lyse flows; green lines are LH lyse flows; orange lines are sample flows; purple lines are waste fluid flows. Similarly hereinafter.
7-15
Fluidics
DIFF measurement As the background solution, the diluent flows through the large volume syring, SV03, SV11, PV18 into the WBC bath. After the blood sample is dispensed by the sample probe to the WBC bath, the DIFF lyse is added by the electromagnetic metering pump (DP1) through the SV01 and the preheat bath. The diluent is forced by the SR through SV06, T13 and T14 into the isolation chamber 1, generating bubbles which mix the sample fluid in the WBC bath. The sample is then supplied along the illustrated orange lines to the bottom end of the flow cell. A sheath flow is generated by the large volume syringe along the illustrated blue lines, and the sample is forced by the small volume syringe into the flow cell for measurement to obtain the differential results of the white blood cells. After the measurement, use the sheath to clean the flow cell and the sample probe. Force the diluent through the SV03, SV11, C11, T35, SV14 and T36 into the isolation chamber 2 to clean the sample supply tube.
BASO measurement & WBC count After DIFF sample enters the sample supply tube, the LH lyse is added by the electromagnetic metering pump DP2 through SV02 to the WBC bath. The diluent is forced by the SR through SV06, T13 and T14 into the isolation chamber 1, generating bubbles which mix the sample fluid in the WBC bath. After the DIFF sample measurement is completed and the sample supply tube is cleaned, the BASO sample is supplied along the illustrated orange lines to the bottom end of the flow cell. A sheath flow is generated by the large volume syringe along the illustrated blue lines, and the sample is forced by the small volume syringe into the flow cell 7-16
Fluidics
for measurement to obtain BASO differential result and WBC count. After the measurement, use the sheath to clean the flow cell and the sample probe. Force the diluent through the SV03, SV11 and PV18 into the WBC bath to clean the sample supply tube and the WBC bath. During the cleaning process, part of the diluent flow away through C11, T35, SV14 and T36 to clean the 3-way connector C11. Finally, the WBC bath is drained by SV15, vacuum chamber (VC) and waste pump.
HGB Count The measurement principle of HGB channel is the colorimetric method, which obtains HGB concentration by comparing the transmitted light intensity between background and blood. The transmitted light intensity of the pure diluent in the WBC bath is measured at the beginning of the count. The transmitted light intensity of the diluent with blood is measured after the BASO reaction is completed (before preparation of the BASO sample). The HGB value can be calculated by comparing the above two values.
7.6.3 RBC/PLT Channel Part of the fluidic structure is shown as follows:
7-17
Fluidics The diluent is added by the SR along the blue line (T3, T18, SV05, T21) to the RBC bath. The diluted blood sample is dispensed by the sample probe to the RBC bath, and then is mixed by the bubbles generated when waste cleaning fluid (for cleaning the DIFF sample fluid in the sample supply tube) enters the isolation chamber 2 through SV14 and T36. The sample is aspirated by the negative pressure in the vacuum chamber into the secondary bath (orange lines in the illustration). The cells will be measured while passing through the aperture. The sample volume is calculated from the count duration. After the measurement, the RBC bath is drained by the waste pump, the vacuum chamber and the SV13. In order to clean the secondary bath, the diluent is forced by the syringe through SV07, T51 and T52 into the secondary bath, then through T43 and SV09 into the probe wipe, and drained by the waste pump.
7.6.4 Precautions for Assembly and Service Precautions for installation of sampling assembly No.
Precautions
Strap the tube above the sample probe at the positioning hole to prevent the tube connector from being stressed by the vertical motion of the sample probe
1
2
Move the sampling assembly horizontally and vertically to ensure that the sample tube is unobstructed with no folding and interference with the preamplifier, fluidics separator, right door, motor, valves and tube straps
3
Ensure the sample tube is not squeezed or deformed at the tube straps
4
Ensure there is no folding or interference when the wipe fluid tube is moving horizontally or vertically in the sampling assembly
5
When the sample probe is in the top position, keep a distance of 5±0.1mm between the probe tip and the lower end of the wipe
Precautions for installation of reaction bath assembly No.
Precautions
1
Case T59 and T60 with flexible tubes
2
The waste tube for the reaction bath needs to be wrapped in the vertical direction to a height above the liquid level with 3mL of liquid in the bath
3
Install the aperture so that the surface with the tapered bore faces the primary bath
Precautions for Servicing the Whole Fluidics No.
Precautions
1
The tubes shall be unobstructed with no twisting, squeezing, creases and folds
2
Never bend any of the tubes. Pay special attention to the Teflon tubes. If any Teflon tube is folded, be sure to replace it with a new tube. When a change in direction is needed, use a large arc for transition.
3
When cutting the tubes, the cutting face shall be perpendicular to the axis of the tube. 7-18
Fluidics
4
When connecting the adapter with the Teflon tube, make sure the insertion depth is 13~15mm. Keep no clearance between the two connected rigid tubes as far as possible. Keep the end of the Teflon tubes smooth and unwrinkled.
5
Strap the connections between any 1.0 Teflon tubes and the adapter. Strap at a position near the end of the Teflon tube, and leave 3-5 mm of Telfon tube aside.
6
When connecting hoses with connectors, valve ports or dosing tubes on the reaction bath, the end of the hose shall be fully inserted beyond the barbs.
7
It is not necessary to over tighten the straps for fastening the tubes.
8
For T-adapters, the side ports and the middle port shall be treated differently. Please assemble in strictly accordance with the illustration. There are strict tolerance requirements for lengths of the following tubes: T4 and
9
T33: ±1 mm, T63: ±2 mm， T7, T8: ±3 mm. Tolerances for the other tubes: for length less than 50 mm, the tolerance is ±1 mm; for length between 50 and 400 mm, the tolerance is ±2 mm; for length more than 400 mm, the tolerance is ±5 mm.
10
When connecting or replacing tubes on the analyzer, never use any blades or other sharp tools.
11
Never scald any hose with hot water.
12
Before or after assembly or maintenance, keep all the hoses, connectors or fluidic components intact and in good condition without any scratches, deformation or distortion.
13
Thick 50 tubes can not be used again after disconnected from valve ports or connectors
14
Cut T75 and case it between T34 and C11
15
Assemble the check valves so that the bigger end is connected to the preheat bath
16
Assemble the filters in the right direction so that the words 43 μm is shown from top to bottom
7.7. Introduction to Sequences Taking the WB-CBC+DIFF mode as an example:
7.7.1 Measurement sequence in WB-CBC+DIFF mode Measurement time in WB-CBC+DIFF mode adds up to 60 s. The sequence is as follows:
7-19
Fluidics
0~0.9 s The small volume syringe of the SR syringe linkage aspirate 15 µL of blood sample from the sample probe The large volume syringe aspirates 600 µl of diluent from the diluent tank 0.1 s Measure the HGB blank voltage 0.3~2.8 s The liquid pump (LP) is turned on to drain the WBC bath 1~2.7 s Aspirate 5360 µl of diluent with the SR (with SV03 and PV18 energized and SV11 open to T64) 0.1~3.1s
Burn the aperture on the RBC bath
7-20
Fluidics
2.8~3.8 s The sample probe travels up to the wipe position 4.2~5.5 s The sampling assembly swings to the position above the WBC bath 2.9~4.2s Use the SR to clean the interior and exterior of the sample probe, and keep the LP pumping the waste fluid during the whole process 4.2~5.3 s The WBC bath is drained for the second time
7-21
Fluidics
5.5~6 s SR injects 240 μL of background solution to the WBC bath 5.2~6 s The sample probe travels down into the WBC bath 6.1~6.5 s The small volume syringe of the SR slowly injects 18 μL of blood through the interior of the sample probe The large volume syringe injects 720 μl of fluid to clean the inlet of the RBC bath 6.55~7.4 s The syringe quickly injects 312 μl of fluid to clean the sample probe (with SV03 energized) 5.3~7.3 s The RBC bath is drained
7-22
Fluidics
7.5~8 s Inject the diluent through SV06 into the isolation chamber 1 to generate bubbles which mix the sample fluid in the WBC bath 7.4~8.1 s The sample probe travels up to the wipe position and the LP draws waste fluid from the wipe 8.1~8.4 s The interior of the sample probe is cleaned and the LP draws waste fluid from the wipe (to 9.2 s) 8.5~9.1 s The syringe aspirates 1580 μl of diluent from the diluent tank 8.8~9.6 s The sample probe travels down into the WBC bath 8.6~10.6 s DP1 aspirates the DIFF reagents
7-23
Fluidics
9.6~10.3 s The small syringe aspirates 12 μl of diluted sample through the probe from the WBC bath; the large syringe aspirates 480 μl of diluent from the diluent tank 10.3~11.3 s The sample probe travels up to the wipe position; the exterior of the probe is cleaned by the wipe; the LP draws waste fluid from the wipe 10.6~11.6 s Use DP1 to add DIFF reagent to the WBC bath 11.4~12.3 s Inject the diluent through SV06 into the isolation chamber 1 to generate bubbles which mix the sample fluid in the WBC bath 11.2~11.9 s The sampling assembly swings to the position above the RBC bath 9.2~10.1 s ,11.4~12.1 s The RBC bath is drained.
7-24
Fluidics
12.4~13.3 s SR injects 1600 μL of background solution through SV05 to the RBC bath. 12.3~13.2 s The sample probe travels down into the RBC bath 13.4~14.9 s The sample probe dispenses the blood and clean the interior with 800 μL of fluid 15.4~16.6 s The sample probe travels up to the wipe position and the LP draws waste fluid from the wipe
7-25
Fluidics
SV08
CV1 J29 Preheat Bath
T26
T72
T54
T70
DIFF Reagent Bottle T55 C7
T16 T41 T46
C16
C8 T58
SV10
Transducer T56
T57
T67
T66
T43
T74
SV09 T44
Waste Tank
WASTE C25
C24 T69
LP T68
SR
15~17.3 s The syringe aspirates the fluid 17.7~18.8 s Aspirate 380 μL of DIFF sample fluid from the WBC bath into the sample supply tube (T63 and T65) 19.2~19.8 s Aspirate 200 μL of diluent through C11, T35 and SV14 into T63; adjust the position of the DIFF sample fluid in the sample supply tube 18.1~19.5 s DP2 aspirates the LH reagent 17~18 s The sampling assembly swings to the top sampling position
7-26
T73
VC
Diluent Tank
SPB
J1-T4J2
J27-T22-J28
J3-T5
T2 T1
C9
SV15
J5-T7-J6T8
J4-T6
SV03
T39
T42
T10
T53
SV13 T38
T37
T36
T11
C20 C21
SV12 C13 T62
T40
T15
T14
J18-T60J19
C12 T61
C6
Isolation Chamber 2
C5
T52
T33
SV11 C26
T51
C10
J16-T59J17 Isolation Chamber 1
T34
Case T75
SV14
T13
Hydraulic Sensor
RBC
C18 C19 T71
T29
J9 C11
J10-T35J11
J12-T45J13
J22-T64-J23-T65J24
T3 T9
SV06 T12
C4
SV16
LH Reagent Bottle
J30-T78J31
T18
WBC PV18
J20-T63J21
C1
T47
SV07
J25-T23-J26
C2
T50
SV02 DP2
SV04
C3
C15
DP1
Case T79
Temperature Sensor
C23
T49
J14-T48-J15-T80-J32
T77
T17
C27
C22
T30 SV01
T32
T20
T24
T21 SV05
T76
DILUENT
C14
T25 J7-T31J8
LF
C17
T19
Fluidics
19.5~20.5 s Use DP2 to add LH reagent to the WBC bath 19.8~20.5 s Inject the diluent through SV06 into the isolation chamber 1 to generate bubbles which mix the sample fluid in the WBC bath 20.5~31.6s The large syringe injects the diluent through SV04 into the flow cell to form the sheath 20.5~20.7 s SV03 ON; the sample in T65 enters the flow cell quickly by the help of the large syringe 20.7~31.6 s SV03 OFF; the small syringe injects the sample from the supply tube into the flow cell to form a stable sample stream 22.2~31.3 s DIFF measurement 31.2 s Measure the HGB voltage
7-27
Fluidics
SV08
J29
J7-T31-J8
SV01
PV18
T72
T54 DIFF Reagent Bottle T55
T70
J18-T60-J19
T41 C16
C8
T57
T58 SV10
Transducer T67
T66
T43
T44
Waste Tank
WASTE C25
C24 T69
LP T68
SR
31.7~33.6 s The large volume syringe aspirates the diluent from the diluent tank ; the small syringe aspirates 156.3 μl of sample fluid from the WBC bath 34~35.5 s Clean the sample supply tube with SV11 and SV14; clean the flow cell with SV04 and SV16; inject the waste fluid into the isolation chamber 2 to generate bubbles for mixing the sample in the RBC bath 31.5~39.1 s Create negative pressure in the vacuum chamber
7-28
T73
VC SV09
Diluent Tank
SPB
T74
J1-T4-J2
C7
T16
T46
J27-T22-J28
J3-T5
SV03
T1
C1
C9
T42
T10
T53
T39
SV15
J5-T7-J6-T8
J4-T6
T2
C2
C26
SV13 T38
T37
T36
T11
C20 C21
SV12 C13 T62
T40
T15
T14
SV11 Hydraulic Sensor
T71
C6
T56
C5
C18 C19
T52
T33
C12 T61
SV14
T13
C10
Isolation Chamber 2
T34
Case T75
J16-T59-J17 Isolation Chamber 1
SV16
C11 J10-T35-J11
T3 T9
J12-T45-J13
J22-T64-J23-T65-J24
J20-T63-J21
C3
RBC
T51
WBC
SV06
LH Reagent Bottle
J9
T29
SV07
J25-T23-J26
T12
T47 SV02 DP2
SV04
C4
T50
J30-T78-J31
T18
Case T79
Temperature Sensor
C15
DP1
J14-T48-J15-T80-J32
T77
T17
C27
C23
T49
T26
T32
C22
T30
SV05 Preheat Bath
T20
T24
T21
T76
DILUENT
C14
T25
CV1
LF
C17
T19
Fluidics
SV08
CV1 T21
J29
SV05 Preheat Bath
J7-T31J8
C27
T20
C22
C23
T49
T30 SV01
T32
T76
DILUENT
C14
T25
LF
C17
T19
C15
DP1
T50
J14-T48-J15-T80-J32
T47 SV02 DP2
Case T79
C18 C19
SV07
SV04
WBC
RBC
PV18
J25-T23-J26 J20-T63J21 Temperature Sensor
C11 T34
Case T75
C10
T52
T33
C6
C20 C21
SV12 SV16
C12 T61
SV14
C13 T62
SV06 C5
T13
T12
C4
SV13 T14
T37
T38 T39 C9
T36 C3
SV11
C2
Hydraulic Sensor
C26
T53
SV15
J5-T7-J6T8
T46
J4-T6
C16
C8
T57 C1
C7
T16
T11
Transducer
T58 T67
SV10
SV03
T66
T43
SPB VC SV09
WASTE
T44
Waste Tank
C25
C24 T69
LP T68
SR
35.8~37.1 s Aspirate 800 μL of BASO sample fluid from the WBC bath into the sample supply tube (T63 and T65) 37.4~51.2 s The large syringe injects the diluent through SV04 into the flow cell to form the sheath 37.4~37.6s SV03 ON; the sample in T65 enters the flow cell quickly by the help of the large syringe 37.6~51.2 s SV03 OFF; the small syringe injects the sample from the supply tube into the flow cell to form a stable sample stream 39.6~51.1 s Perform BASO measurement and WBC count 35 s The constant current source of RBC bath turns ON 35 s~49 s SV12 valve ON; the fluid in the primary RBC bath is forced by the vacuum through the aperture into the secondary bath 39.8~48.8 s Perform RBC and PLT counts
7-29
Fluidics
51.3~52 s PV18 stays ON; the sample supply tube and the 3-way connector C11 is cleaned by SV03, SV11, and SV14 Clean the flow cell and the sample probe by SV04 52.1~53.8 s The syringe aspirates the fluid 51.1~52.9 s The RBC bath is drained
7-30
Fluidics
SV08
J29
J7-T31-J8
SV01
T72
T54
Bottle
DIFF Reagent
T70
J18-T60-J19
T41 C16
C8 T58
SV10
Transducer T56
T57
T67
T66
T43
T74
SV09 Waste Tank
WASTE C25
C24 T69
SR
The WBC bath is drained SV14 ON; C11 is flushed SV04 ON, the sample probe is flushed PV18 OFF; the pneumatic pinch tube and the WBC bath are flushed The WBC bath is drained
7-31
LP T68
T73
VC
Diluent Tank
SPB
T44
52.9~54.2 s 53.8~54.3 s 53.9~54.2 s 54.1~55.7 s 55.5~56.9 s
T55 C7
T16
T46
J27-T22-J28
J3-T5 J1-T4-J2
C9
T42
T10 T2 T1
SV03
T39
SV15
J4-T6
C1
SV13 T38
T37
T36
T11
C20 C21
SV12 C13 T62
T40
T15
T14
Isolation Chamber 2
C6
C5
J5-T7-J6-T8
T71
T52
T33
SV11
T53
T51
C10
C12 T61
SV14
T13
T12
T34
Case T75
J16-T59-J17 Isolation Chamber 1
SV16
C11 J10-T35-J11
T3 T9
SV06
J12-T45-J13
J22-T64-J23-T65-J24
J20-T63-J21
C2
RBC
PV18
Temperature Sensor
LH Reagent Bottle
T29
J9
WBC
C26
C18 C19
SV07
J25-T23-J26
Hydraulic Sensor
T47 SV02 DP2
SV04
C3
T50
J30-T78-J31
T18
Case T79
C4
C15
DP1
J14-T48-J15-T80-J32
T77
T17
C27
C23
T49
T26
T32
C22
T30
SV05 Preheat Bath
T20
T24
T21
T76
DILUENT
C14
T25
CV1
LF
C17
T19
Fluidics
55.8~56.9 s 57~58.9 s 59.1~60 s 59.1~59.4 s 58.3~59.4 s 59.4~60 s
Add 2560 μL of diluent to the RBC bath with syringe Add 2018 μL of diluent to the WBC bath with syringe The sample probe travels to the sampling position Use the small syringe to create a 4 μL isolation bubble in the sample probe The liquid pump (LP) is turned on to drain the wipe SV10 ON; the vacuum is released
7.7.2 Measurement sequence in PD-CBC+DIFF mode Measurement sequence in PD-CBC+DIFF mode is basically the same with the sequence in WB-CBC+DIFF mode, except that: 1. Because the blood sample has been prediluted outside the analyzer, 200 μL of blood is aspirated in the PD mode.
7-32
Fluidics
7.7.3 Measurement sequence in CBC mode Compared with the sequence in CBC+DIFF mode, the measurement sequence in CBC mode is basically the same except that it does not include the fluidic actions of DIFF and optical channels. The main differences are as follows: 1. Sample volume. The sample volume is 15 μL in the WB-CBC+DIFF mode, 11.7 μL in the WB-CBC mode. The sample volume is the same between the PD-CBC+DIFF mode and PD-CBC mode. 2. There is no actions related to DIFF measurement, including addition of DIFF reagent, preparation of DIFF samples, DIFF measurement, and cleaning process of the tubes and the flow cell after the DIFF measurement.
7.7.4 Introduction to the Maintenance Sequences Probe cleanser maintenance (shutdown sequence) The locations soaked by the probe cleanser are shown below. The orange lines are the locations soaked by the probe cleanser, and the blue lines are the locations passed by the probe cleanser. An enhanced probe cleanser maintenance sequence will be called every 300 times of sample measurement. The main difference between the enhanced and the regular probe cleanser maintenance sequence is the soaking time. The soaking time of enhanced maintenance is 6.67 minutes longer than regular maintenance. In the Maintenance screen, the probe cleanser maintenance is defaulted as enhanced probe cleanser maintenance.
7-33
T24
T72
T71
LH Reagent Bottle
T51
T70
DIFF Reagent T40
Bottle
T54
J18-T60-J19
Isolation Chamber 1
J16-T59-J17 Isolation Chamber 1
J10-T35-J11
J12-T45-J13
J22-T64-J23-T65-J24
T3 T9
T73 T74
Startup cleaning The fluidic actions on startup can be divided into three procedures: 1. Initialization of fluidics components: initialization of sampling assembly and syringe assembly; 1 metering pump action (without consumption of reagents); creating vacuum and releasing vacuum. 2. Cleanup: including cleaning of all the tubes and components on the analyzer; removing bubbles from the flow cell; discarding 1 ml of DIFF reagent and 0.2 ml of LH reagent. 3. Background: WB-CBC+DIFF measurement If the background fails, perform the cleanup again and measure the background. For startup after an abnormal shutdown, perform the cleanup twice.
Standby The instrument will enter standby status after idling for 15 to 30 minutes (defaulted as 15 minutes). After entering standby status, operations without fluidic actions can be performed from the screen. Exit standby status 1: Standby for less than 1 hour. Clean the exterior of the sample probe and the WBC bath and rebuild the 7-34
Diluent Tank
T56
T42
J27-T22-J28
J1-T4-J2
J3-T5
T10
T41
T15
T55
J9
T29
J30-T78-J31
T18
T77
T17
T26
Fluidics
Fluidics
isolation bubble without consumption of lyse. Exit standby status 2: Standby for more than 1 hour and less than 5 hour. Clean the interior and exterior of the sample probe, the WBC bath, the RBC bath, the sample supply tube and the flow cell, and rebuild the isolation bubble without consumption of lyse. Exit standby status 3: Standby for not less than 5 hour. The same as cleanup on startup, including cleaning of all the tubes and components on the analyzer; removing bubbles from the flow cell; discarding 3 ml of DIFF reagent to eliminate the effects of bubbles in the preheat bath tube; discarding 0.2 ml of LH reagent to eliminate the effects of crystal and bubbles at the inlet.
7-35
8 Hardware System 8.1. Hardware System Overview The hardware system consists of not only power board, main control board, indicator board and analog drive board for touchscreen, but also drivers and components that requires power supply, such as motors, valves, pumps, sensors, display and input power filter, and connecting wires between different boards and components.
8.1.1 Functional Block Diagram The functional block diagram of the hardware system is shown in Figure 8-1.
Data Channel Sensor
Signal preprocess
Master Control Signal sampling
Signal preprocess
Channel Control
Sample review
Touch screen
Result display
TFT monitor
Result print
USB printer
Data storage Data manager
Network interface
Input module
Bar-code scanner
Drive/Detect Control Valve and pump control
Motor control
Optical switch control
Alarm control
POWER supervise
POWER
Start key
Supervisor system
Indicator board
State supervise
Figure 8-1 Functional block diagram of the hardware system The hardware system consists of five modules, including power supply, data stream channel, control system, drive components and peripherals. The functions of each modules are as follows: 1.
Power supply: provides all kinds of power for each board, component and devices in the hardware system;
2.
Data stream channel: for extraction, modulation, amplification, collection and preprocessing of signals;
3.
Control system: for data collection, data processing, result display and sample storage. The
8-1
Hardware System control system is also the scheduling and managing center, which controls and responds to all the peripherals and devices; 4.
Drive/monitor: for controlling valves, pumps and motors, monitoring photocoupler and other important parameters, collecting measurement data and triggering alarms;
5.
Peripheral interface: includes display/touchscreen, USB ports (for printer, keyboard and barcode scanner) and Ethernet interface. Peripherals also includes operation indicators and key inputs.
8.1.2 Electrical Connection Block Diagram The diagram below is the hardware connection block diagram. For electrical connection diagram of the optical system, please refer to the optical system hardware section.
Figure 8-2 Electrical connection block diagram of the hardware system The detailed electrical connection diagram of the hardware system is shown in Appendix C.
8.1.3 System Troubleshooting Common hardware system failures can be divided into board failures, wire failures and component failures. Generally, the troubleshooting procedures of these failures can be found in the board troubleshooting section below. However, when the system power supply can not be guaranteed 8-2
Hardware System (such as failure to power up or immediate system self-protection after power-up), it will be necessary to start troubleshooting from the system level. Figure 8-3 shown the flowchart for power anomaly check. Figure 8-4 shows the filter which is located below the rear of the analyzer, used for controlling power supply and frequency filtering.
Figure 8-3 Abnomal power troubleshooting flowchart
Figure 8-4 Actual picture of the filter Figure 8-5 shows the troubleshooting flowchart for immediate self-protection after power-up.
8-3
Hardware System
Figure 8-5 Troubleshooting flowchart for power-up protection
8.2. Digital Control Board 8.2.1 Overview The digital control board consists mainly of a digital part and an analog part. The analog part implements mainly the A/D conversion of analog signals into digital signals, such as optical channel and monitoring voltage. As the essential part of the digital control board and the whole hardware system, the digital part implements data processing, output, control and communication. Section 8.2 of this manual is the guideline for service and troubleshooting of the control board.
8.2.2 Components The block diagram of the control board is shown in Figure 8-6. The control board consists mainly of digital circuit, plus part of the ADC circuit which implements the A/D conversion. The digital circuit module implements data processing, result saving and output. As the essential part of the digital control board and the whole hardware system, the digital circuit is also responsible for control and communication. The ADC circuit is mainly responsible for digitizing WBC, RBC/PLT, optical signals and all kinds of analog monitoring signals with an A/D converter. The control part of the control board employs the “CPU+FPGA” structure to achieve the following main functions: A/D conversion Data processing Peripheral interface implementation Control interface extension
8-4
Hardware System
Figure 8-6 Block diagram of the control board Description A/D conversion Converts the analog signals to digital signals which can be processed by FPGA or CPU. Data processing The digital signals obtained by FPGA from A/D samples are digitally filtered to save the particle parameters. The data then is transmitted to CPU by interruption or other methods for further processing. After processing, the results will be shown on the LCD. Peripheral interface implementation The CPU module provides a platform for system software, interfaces for peripherals including indicator board, LCD, Ethernet, USB printer, USB barcode scanner, keyboard and USB drive, etc., the JTAG interface for online programming the FPGA configuration chip, and the CPU debug interface. Control interface extension Provides control logic and interface for LCD, SD card and touchscreen, etc.
8-5
Hardware System
Figure 8-7 Schematic of the digital control board module Interface definition The functions of the 13 socket interfaces on the control board is listed in Table 8-1. The locations of each interface on the board is shown in Figure 8-8.
J78 Indicator
J99 Start KEY
J81 Communication interface
J68 POWER
J86 supervise signal interaface J77 control for Analog&driver board and optical system
J2 USB J3 USB J1 Network
J85 Optical signal input interface
J16 TFT Monitor
8-6
J4 TFT Monitor Backlight
J67 Touch Screen
Hardware System
Figure 8-8 Interface locations of the digital control board Table 8-1 Function list of the control board interfaces
Interface
Function
PIN Function Description
Description
J1
Ethernet interface
/
Network interface
J2
USB port
/
Connect different USB peripherals
J3
USB port
/
Connects different USB peripherals
J4
LCD backlight
PIN1: Backlight power
Drives backlight and
control interface
supply, 12V
control the
PIN3: Backlight power
brightness
supply, GND PIN5: Enables backlight, 3.3V PIN6: Drives backlight, 0.7~1.2V J16
LCD signal
PIN3: Power supply, 3.3V
Provides differential
interface
PIN5: GND
signal for the LCD to display data
J67
J68
Touchscreen
PIN1: Power supply, 3.3V
Connects the
signal interface
PIN4: GND
touchscreen
Power interface
PIN1: Power supply, 5V,
Supply power for
GND
the boards
PIN2: Power supply, 12V GND PIN3: Power supply, 5V PIN4: Power supply, 12V J77
J78
Analog board
PIN1: GND
Analog board
control and optical
PIN22: 3.3V
control and optical
SPI interface
PIN24: 5V
SPI interface
Indicator board
PIN1: 5V
Drives indicator and
interface
PIN2: RED_LED
buzzer
PIN4: GREEN_LED PIN6: YELLOW_LED 8-7
Hardware System
PIN9: GND J81
Analog board and
/
Analog board and
control board SPI
control board SPI
interface
communication interface
J85
Optical signal
PIN1: FS Signal
Interface for optical
input interface
PIN3: SS Signal
signal inputs
PIN5: SF Signal
amplified by the
PIN7: WBC Signal
analog board
PIN9: RBC Signal PIN11: 5V PIN12: 5V PIN13: GND PIN14: GND J86
Analog board
PIN13: 5V
Provides supervisory
supervisory signal
PIN20: GND
signals for the
interface J99
control board
Aspirate key
PIN2: GND
Aspirate key switch
switch interface
interface
8.2.3 Adjustment and Tests All the adjustable parameters of this board are adjusted by commands. To adjust the parameters, perform parameter adjustment in the software interface. Function definition of LED indicators Functions of LED indicators on the control board are shown in Table 8-2: Table 8-2 Function definition of LED indicators on the control board
Indicator D6
Function
LED OFF Diagnosis
Network interface indicator
Network disconnected, network cable
which flashes after
failure, control board failure
connected with network cable and PC D7
Network interface indicator
Network disconnected, network cable
which is illuminated after
failure, control board failure
connected with network cable and PC
8-8
Hardware System
D40
D44
USB related signals.
USB peripheral failure, control board
Illuminated after power-up.
failure
power chip indication signal.
Power board failure, control board
Illuminated after power-up.
failure
Function definition of test points The function of test points are defined in Table 8-3. The zone code of test points are shown in Figure 8-7. In order to exclude problems caused by shorted peripherals, remove all the wires except the power cable before diagnosing a power supply problem. Table 8-3 Function definition of test points on the control board
No. 1
Test Point TP1
Description
Zone
VDD18 1.8 V
Zone 6
voltage monitoring
Diagnosis The voltage is not 1.8V: control board failure or power board failure
point 2
TP2
VDD 3.3V voltage
Zone 6
monitoring point 3
TP3
VDD12 1.2 V
The voltage is not 3.3V: control board failure or power board failure
Zone 6
voltage monitoring
The voltage is not 1.2V: control board failure or power board failure
point 4
TP4
Backlight enable
Zone 5
The voltage is not 3.3V: control board failure
Zone 5
The voltage is not 0.7~1.2V: control board
signal 5
TP5
Backlight PWM signal
6
TP6
Backlight GND
failure Zone 5
/
signal 8
TP9
Analog ground
Zone 1
/
9
TP10
ADC U79 SPI
Zone 1
/
Zone 1
/
Zone 1
The voltage is not 2.5V: control board failure
clock signal 10
TP11
ADC U78 SPI clock signal
11
TP12
ADC U79 2.5V reference voltage
or connection failure between control board J86 and analog drive board
12
TP13
ADC U78 2.5V
Zone 1 8-9
The voltage is not 2.5V: control board failure
Hardware System
reference voltage
or connection failure between control board J86 and analog drive board
13
TP14
FS analog signal
Zone 7
/
14
TP15
FS analog GND
Zone 7
/
15
TP16
FS AD conversion
Zone 7
/
clock 16
TP17
SF analog signal
Zone 7
/
17
TP18
SF analog GND
Zone 7
/
18
TP19
SF AD conversion
Zone 7
/
clock 19
TP20
SS analog signal
Zone 7
/
20
TP21
SS analog GND
Zone 7
/
21
TP22
SS AD conversion
Zone 7
/
Zone 7
/
clock 22
TP23
RBC AGND
23
TP24
RBC analog signal
Zone 7
/
24
TP25
RBC AD analog
Zone 7
/
signal 25
TP26
RBC VREF
Zone 7
/
reference voltage 26
TP27
WBC VREF
Zone 7
/
reference voltage 27
TP28
WBC AGND
Zone 7
/
28
TP29
WBC analog
Zone 7
/
Zone 7
/
Zone 5
/
Zone 5
/
signal 29
TP30
WBC AD conversion clock
31
TP32
Touchscreen interruption signal
32
TP33
Touchscreen reset signal
33
TP34
Digital ground
Zone 5
/
34
TP35
VDD25 2.5 V
Zone 6
The voltage is not 2.5V: control board failure
voltage monitoring
or power board failure
point 8-10
Hardware System
35
TP36
5 V voltage
Zone 6
monitoring point 36
TP37
12V voltage
The voltage is not 5V: control board failure or power board failure
Zone 8
monitoring point
The voltage is not 12V: control board failure or power board failure (the ground connection of this voltage is J68_PIN2 instead of GND)
37
TP44
DDR2 0.9V
Zone 6
voltage monitoring
The voltage is not 0.9V: control board failure or power board failure
point 38
TP45
DDR2 0.9V
Zone 6
reference voltage
The voltage is not 0.9V: control board failure or power board failure
monitoring point 39
TP38,
Digital ground
Zone 6
/
3.3 V voltage
Zone 5
The voltage is not 3.3V: control board failure
TP39, TP40, TP41, TP42, TP43, TP46, TP47 40
TP48
monitoring point
or power board failure
8.2.4 Troubleshooting Table 8-4 lists common symptoms and relative corrections for the control board only from the hardware side, not including symptoms caused by software. However, many problems will need to be tested by software. Before troubleshooting problems related to the control board, perform the following checks: 1.
whether there is any loose connecting wire or unreliable connection on the control board;
2.
whether the bit numbers on the wires are matching the bit numbers on the control board sockets; whether there is any broken or damaged wire;
3.
whether the input power of board socket J68 is working properly (measured with a multimeter, the voltage between PIN1 and PIN3 shall be 5V, and the voltage between PIN2 and PIN4 shall be 12V);
4.
Verify if the indicator on the data board is normal according to Table 8-2.
After the wire connections, input power and indicators are verified to be normal, troubleshoot the problem in accordance with Table 8-4.
8-11
Hardware System Table 8-4 Troubleshoot the control board
No. 1
Symptom
Evidence
LCD black
1. Check if the connecting wires between the
screen
Solution Reconnect the
control board and the backlight interface and
connecting wires
LCD is reliable. If the problem is solved after
from the control
reconnection and power-up, then the problem is
board to the backlight
caused by unreliable wire connection. Otherwise,
and LCD
proceed to the next step. 2. Replace the connecting wires from the
Replace the
control board to the backlight and LCD. If the
connecting wires
problem is solved, then the problem is caused by
from the control
connection failure. Otherwise, proceed to the next
board to the backlight
step.
and LCD 3. Measure the voltage between PIN1 and
PIN3 at J4 with a multimeter. If the measured
Replace the control board
value is not between 11.50~12.50, then the problem is caused by backlight power failure. Otherwise, proceed to the next step. 4. Measure the voltage between TP5 and TP6 with a multimeter. If the measured value is not between 0.7~1.1V, then the problem is caused by backlight brightness control failure. Otherwise, proceed to the next step. 5. Measure the voltage between TP4 and TP6 with a multimeter. If the measured value is not between 3.10~3.50V, then the problem is caused by backlight enable control failure. 6. Replace the LCD. If the problem is solved, then the problem is caused by LCD
Replace the LCD
component failure. Otherwise, proceed to the next step. 2
LCD
1. Reconnect the connecting wires from the
Reconnect the
display
control board to the backlight and LCD. If the
connecting wires
flickers
problem is solved after reconnection and
from the control
power-up, then the problem is caused by
board to the backlight
8-12
Hardware System
unreliable wire connection. Otherwise, proceed to
and LCD
the next step. 2. Replace the connecting wires from the
Replace the
control board to the backlight and LCD. If the
connecting wires
problem is solved, then the problem is caused by
from the control
connection failure. Otherwise, proceed to the next
board to the backlight
step.
and LCD 3. Replace the control board. If the problem
is solved, then the problem is caused by
Replace the control board
differential conversion chip (U22) or AM1808 board failure. Otherwise, proceed to the next step. 4. Replace the LCD (LCD component). If the problem is solved, then the problem is caused
Replace the screen assembly
by LCD component failure. 3
LCD
1. Reconnect the connecting wires from the
Reconnect the
displays
control board to the LCD. If the problem is
connecting wires
strange
solved after reconnection and power-up, then the
from the control
patterns
problem is caused by unreliable wire connection.
board to the LCD
Otherwise, proceed to the next step. 2. Replace the connecting wires from the
Replace the
control board to the LCD. If the problem is
connecting wires
solved, then the problem is caused by connection
from the control
failure. Otherwise, proceed to the next step.
board to the LCD
4. Replace the control board. If the problem is solved, then the problem is caused by control
Replace the control board
board failure. Otherwise, proceed to the next step. 5. Replace the LCD (LCD component). If the problem is solved, then the problem is caused
Replace the screen assembly
by LCD component failure. 4
Failed
1. Check if the configured IP of the PC is
Set the IP
network
within the same network segment with the control
address to 10.0.0.3
connection
board (10.0.0.X). If not, set the IP to 10.0.0.3. If the problem is solved, then the problem is caused by incorrect IP address. Otherwise, proceed to the next step. 8-13
Hardware System
2. D6 and D7 are not illuminated after
Reconnect or
power-up and connected with PC, and there is
replace the network
poor contact or bad network cable. Otherwise,
cable
proceed to the next step. 3. D6 and D7 are not illuminated, but the network cable contact is normal. 5
USB port
1. If D40 is not illuminated after power-up,
is not
then the USB HUB chip (U56) fails. Otherwise,
working
proceed to the next step.
properly
2. If D40 is illuminated after power-up, replace the USB peripherals (USB mouse, USB
Replace the control board Replace the control board
Replace the USB peripherals
keyboard or USB drive). If the problem is solved, then the problem is caused by USB peripheral failure. Otherwise, proceed to the next step. 3. After all these steps, if the problem still exists, replace the digital control board. 6
Clock
1. Turn off the power and measure the
reset at
voltage between the two end of Battery clip B1
every
with a multimeter with the battery in place. If the
startup
measured value is less than 1.8V, then the
Replace the control board Replace the button battery
problem is caused by a low battery. Otherwise, proceed to the next step. 2. Measure the voltage of pin 1 or pin 4 at X10 with a multimeter. If the measured value is 0V, then the problem is caused by crystal resonator X10. 7
No
1 Check if the connecting wire of the
response
aspirate key is loose or broken. If so, reconnect or
when
replace the wire.
pressing the
2. If step 1 does not solve the problem,
aspirate key
remove the aspirate key switch plate to check if there is fluid inside. If so, clean the fluid and reinstall the switch plate.
8-14
Replace the control board
Hardware System
8.3. Analog Drive Board 8.3.1 Overview The functions of analog drive board includes measuring and amplifying the signals from the RBC channel, the HGB channel and the optical channel, and outputting them to external boards; responding commands of the control board; controlling mechanical components (such as motor drive assembly) and fluidics components (such as valves and pumps); detecting component position when controlling mechanical components (through the photocoupler); detecting pressure when controlling fluidics components (such as pumps); reporting necessary information (temperature, voltage, etc.) to the control board.
8.3.2 Components The analog drive board can be divided by modules into four modules: power module, master control module, detection module and power driving module. The modules are shown in Figure 8-9.
Analog part Analog power
Temp sensor and optical signal amplifier
1
2
Digital part
Liquid pressure sensor
Pump and Valve Driver
4
3
Motor Driver
5 7
RBC
11 12 9 HGB
Signal preprocess
8 Supervise signal
6 Communication Module
13 Master Control
Figure 8-9 Module division of the analog drive board The analog part modulates and amplifies the WBC, RBC/PLT and HGB signals so that the signals are basically real and ready for A/D conversion before entering A/D. The A/D module is the interface between the analog circuit and the digital circuit for sampling the above-mentioned sensor signals and other supervisory signals and converting analog signals to digital signals for digital circuit.
8-15
For Debug
Air pressure sensor
10
Hardware System 1. The power supplies power for all the electronic devices on the analog drive board, including both input power from the analog drive board, and the power converted by the power chip; 2. The master control module is responsible for communicating with the control board and task scheduling; 3. The detection module is responsible for collecting information such as temperature, pressure, voltage and fluid in the tubes; 4. The power driving module is responsible for driving the power components such as motor, heater, fan, valves and pumps; 5. The RBC detection circuit provides the RBC module with constant current source and functions such like RBC signal modulation; 6. Provides functions such like modulation of optical signals and HGB signals.
Figure 8-10 Location of connectors on the analog drive board
Table 8-5 Function list of the analog drive board interfaces
Interface J1
Function Float sensor
PIN
Description
PIN2: GND
Detect float status
Analog drive board
PIN1: Optical
Outputs board status
status signal output
temperature
information to the
PIN2: Aperture
control board
interface J2
supervisory voltage 8-16
Hardware System
PIN3: Gas pressure PIN4: AGND PIN5: Fluid pressure PIN6: -12V supervise PIN7: Constant current source supervise PIN8: Power 24V supervise PIN9: Laser current supervise PIN10: Power 12V supervise PIN11: Analog 12V supervise PIN13: Analog 5V output PIN20: AGND J3
Optical board control signal
PIN22: 3.3V, provided by the control board
Controls the optical boards. This signal is
PIN24: 5V provided by
only buffered by the
the control board to DPM
analog drive board.
PIN23: GND J4
Optical analog signal output
PIN1: FS output
Optical signal
PIN3: SS output
output modulated by
PIN5: SF output
the analog drive
PIN9: RBC output
board
PIN14: AGND J5
HGB bath interface
PIN1: AGND PIN2: HGB LED+ PIN4: HGB current input PIN5: HGB LED-
J6
RBC bath interface
PIN1: Aperture electrode B PIN2: Aperture
8-17
HGB bath interface
Hardware System
electrode A PIN3: AGND J8
Analog power
PIN1: AC120_A
interface
PIN2: AC120_B
Supply analog power for the boards
PIN4: Analog 12V PIN5: Analog -12V PIN3: AGND PIN6: AGND J9
Optical system
PIN3: FS input
Optical board
signal input and
PIN7: SS input
analog signal output
control output
PIN11: SF input
and control signal
PIN15: Laser current
input
output PIN18: Laser control PIN16: AGND J10
Temperature sensor
/
3-way temperature
interface J11
Hydraulic sensor
sensor interface /
Hydraulic sensor
interface J12
J13
Photocoupler
interface /
Photocoupler
interface for
interface for
sampling assembly
sampling assembly
Photocoupler
/
Photocoupler
interface for
interface for syringe
syringe assembly
assembly
J14
Valve 13-18 driver
/
Drives valve 13-18
J15
Valve 1-12 driver
/
Drives valve 1-12
Fan interface
/
Fan interface
Waste pump
/
Waste pump
J17, J18, J19 J20
interface
interface
J21
Heater interface
/
Heater interface
J22
Power interface for
PIN1: Power 12V
Digital power
digital part of the
PIN3: Power 5V
interface
analog board
PIN5: Power 24V 8-18
Hardware System
PIN2: GND J23
Motor driver
/
Motor driver
interface J24
interface
Motor driver
/
Motor driver
interface J31
interface
Controls analog
/
Controls analog
drive board DPM
drive board DPM by
by the control
the control board and
board and other
other preserved
preserved
interfaces
interfaces
8.3.3 Sockets and Indicators Function definition of LED indicators Functions of LED indicators on the analog drive board are shown in Table 8-6: Table 8-6 Function definition of LED indicators on the analog drive board
Indicator D102
Function Heater status indicator
D104-D109
Diagnosis LED OFF indicates the heater is not working
Motor status indicator
LED OFF indicates the motor is not working
D112
MCU status indicator
LED OFF indicates MCU is not working. May be caused by analog drive board failure
D115-D117
FPGA controlled LED
LED OFF indicates FPGA is not working. May be caused by analog drive board failure
D118
D119
Digital 24 V power
LED OFF indicates power failure.
indicator
Check the power board and the analog
Digital 12V power
drive board
indicator D120
Digital 5V power indicator
D121
Digital 3.3V power indicator
8-19
Hardware System
D122
Analog 12V power indicator
D123
Analog -12V power indicator
D124
Analog 5V power indicator
D125
Analog -5V power indicator
Function definition of test points Functions of test points on the analog drive board are shown in Table 8-7. The zone codes are shown in Figure 8-8. Table 8-7 Function definition of test points on the analog drive board
Test Point TP19
Description Analog 12V voltage AD
TP21
Diagnosis
Zone
If the voltage is not 2.28V, then the Zone 8
problem may be caused by power failure or
monitoring point
analog drive board failure
FS baseline
/
voltage AD
Zone 8
monitoring point TP22
Analog -12V voltage AD
TP23
If the voltage is not 2.82V, then the Zone 8
problem may be a power failure or analog
monitoring point
drive board failure
56V voltage
If the voltage is not between 1.25~1.5V,
monitoring point
Zone 8
then the problem may be a power failure or analog drive board failure
TP26
Hydraulic sensor output voltage
TP29
Pressure sensor 2.5V voltage
TP30
Zone 3
/
If the voltage is not 2.5V, then the problem Zone 10
may be a power failure or analog drive
monitoring point
board failure
Pressure sensor
/
output voltage
Zone 12
monitoring point TP39,
Motor lock
Zone 5
/ 8-20
Hardware System
TP40,
voltage
TP49, TP58 TP59
Reset chip
Above
Low signal indicates the chip is in reset
output signal
Zone 7
status
TP68
Digital ground
Zone 6
/
TP43,
Motor pulse
TP44,
output
TP51
monitoring point
TP69
D115 signal monitoring point
TP86
Zone 5
Zone 7
Digital 1.2V power
TP87
/
If the voltage is not 1.2V, then the problem Zone 6
board failure
Digital 2.5V
If the voltage is not 2.5V, then the problem Zone 13
monitoring point Digital 3.3V power monitoring point TP89
Digital 12V power monitoring point
TP90
Digital 24V power monitoring point
TP91
may be a power failure or analog drive board failure
Right to Zone 11
Right to Zone 4
Right to Zone 4
Digital 5V power
TP92
may be a power failure or analog drive
monitoring point
power
TP88
/
If the voltage is not 3.3V, then the problem may be a power failure or analog drive board failure If the voltage is not 12V, then the problem may be a power failure or analog drive board failure If the voltage is not 24V, then the problem may be a power failure or analog drive board failure If the voltage is not 5V, then the problem
Zone 5
may be a power failure or analog drive
monitoring point
board failure
AD U41
/
conversion chip voltage
Zone 3
monitoring point TP112
HGB analog voltage output
Zone 9
/
8-21
Hardware System
TP113
HGB assembly current to voltage
/ Zone 9
monitoring point TP115
HGB LED 2.5V monitoring point
If the voltage is not 2.5V, then the problem Zone 9
may be a power failure or analog drive board failure
TP116
Burning voltage switch
TP117
Constant current source switch
TP119,
Laser control
TP120
switch
TP121
RBC relay control signal
TP122
Zone 12
Zone 12
Zone 12
Analog 12V voltage
TP123
Zone 12
/
/
/
If the voltage is not 12V, then the problem Zone 1
may be a power failure or analog drive
monitoring point
board failure
AVDD analog
If the voltage is not 5V, then the problem
5V voltage
Zone 1
monitoring point TP111,
/
Analog GND
may be a power failure or analog drive board failure
Zone 11
TP124,
shield is
TP125
the analog
/
ground TP126
Analog -12V voltage
TP127
If the voltage is not -12V, then the problem Zone 1
monitoring point
board failure
AVEE analog
If the voltage is not -5V, then the problem
-5V voltage
Zone 1
monitoring point TP128
may be a power failure or analog drive
NE555 U75 pulse output
may be a power failure or analog drive board failure
Zone 1
/
Key definitions Functions of keys on the analog drive board are shown in Table 8-9: 8-22
Hardware System Table 8-8 Function definition of keys on the analog drive board
Bit No.
Function
S2
Manually reset the system
8.3.4 Troubleshooting 1) Validation before troubleshooting Before troubleshooting driver related problems, check whether there is any loose connecting wire or unreliable connection on the analog drive board, and whether the bit numbers on the wires are matching the bit numbers on the analog drive board sockets; whether there is any broken or damaged wire. When analog drive board failure is suspected, verify whether the indicators on the analog board are normal in accordance with the table below. After all the indicators is verified to be normal, verify the MCU and FPGA from the software interface (click Menu → click “Status” →“Version information”). If all the versions are correct, troubleshoot the problem according to the problem types listed in (2). 2) Troubleshooting Initially locate the problem by the alarm indication, then troubleshoot the problem according to the type as shown in Table 6-7. Table 8-11 Troubleshooting and solutions
No.
Problem Type
Description
Troubleshooting and solutions
1
Motor and
This problem
1. Check if the board power supply is working
photocoupler
type includes
properly;
but is not
2. Check if the connection between the motor of
limited to:
corresponding channel and the photocoupler is
a. the motor
reliable, if the connectors on both ends are connected
does not work;
properly, if the marks on the photocoupler and motor
b. the motor
connecting wires match their respective locations,
works, but
and if there is any broken or damaged wire;
motor failure or
3. After verifying 1 and 2, try correcting the problem
photocoupler
by performing Remove Error or Self-Test from the
failure is
software screen;
reported
4. Check if the photocoupler surface of the corresponding channel is contaminated by dust or fluids. If so, clean and reinstall the photocoupler. If
8-23
Hardware System
the problem is not solved, replace this photocoupler; 5. If the problem still exits after replacing the photocoupler, replace the analog drive board; 6. If the problem persists, replace the corresponding channel motor; 7. If the problem persists, then the problem may be caused by mechanical component failure (such like too much friction), please troubleshoot this problem as a mechanical problem. Abnormal
1. Check if the corresponding channel motor
motor noise
connecting wire is loose, broken or damaged. If so, please reconnect or replace the wire with the power off; 2. Check if any fastening screw of the mechanical component is loose. If so, please tighten this screw; 3. If both 1 and 2 can be excluded, the problem may be caused by analog drive board failure. Please replace the analog drive board; 4. If the problem persists, it will be necessary to replace the motor assembly.
2
Valves
The valve is not
1. From the Valve Self-test screen, check if the valve
working
is opening and closing correctly (a clap will be heard
properly
on normal open/close of the valve). If so, then the problem is not in the valve drive. Please search for the cause in the fluidics; 2. If the valve is not opening and closing correctly, please check if there is any loose or broken wires or unreliable connection. If so, please reconnect or replace the connecting wire; 3. If the problem persists, use wires of other valves to connect this valve, and check if the problem is in the valve start circuit or in the valve from the Valve Self-test screen (for example, if valve 2 is suspected, use wires of valve 3 to connect valve 2; open and close valve from the Valve Self-test screen; if the
8-24
Hardware System
valve is opening and closing correctly, then the analog drive board is damaged and needs to be replaced; if the valve is not opening and closing correctly, then the valve 2 is damaged and needs to be replaced). 3
Pumps
a. abnormal
1. Check if the pump is able to work properly from
pressure
the Pump Seft-test screen. If it is, search for the
b. the pump
problem in the gas circuit;
does not work
2. If the pump is not opening and closing correctly, please check if there is any loose or broken wires or unreliable connection. If so, please reconnect or replace the connecting wire; 3. If the problem persists, replace the analog drive board; 4. If the problem persists, it will be necessary to replace the corresponding pump.
4
Communication
Communication
1. Check if the control board indicator and the analog
failure reported
board indicator are normal. If not, then replace corresponding board(s); 2. Check if the connecting wire between the control board and the analog board is loose. If so, then reconnect the wire; 3. If the problem persists, replace the connecting wire between the control board and the analog board; 4. If the problem persists, replace the analog drive board and the control board one after another. Most problems will be solved in this way.
5
Waste sensor
False alarm of
1. Check if the connecting wire on the waste
waste status
connector is loose, wet or broken. If so, please disconnect and reconnect the connector, or reconnect the connector after cleaning the fluid, or replace the connecting wire. 2. If not, replace the waste cap assembly.
8-25
Hardware System
8.4. Power Board 8.4.1 Overview The power board provides the analyzer with 6 reliable power outputs, including D5V, A+12V, A-12V, AC120V and P24V. Interface definition There are 6 interfaces for external connections on the power board. 4 interfaces are in socket form, namely J1, J2, J3 and J4; the AC input wire L and N are led from the board side to the plug for external connection; the small inverter board is directly connected to the power board by the interface socket. The locations of each interface on the board are shown below:
A small inverter board Figure 8-11 Schematic diagram of the power board The functions of each interface are listed below: Table 8-12 AC input wires
PIN
Definition
L
Connected to utility live wire
N
Connected to utility neutral wire
Table 8-13 Output socket connectors
Name D5V
Socket No. J1
Description PIN1: GND PIN2, PIN3: 5V
P12V, P24V
J2
PIN1: GND PIN2: 12V 8-26
Hardware System
PIN3: 24V A+12V, A-12V
J3
PIN1, PIN4: GND PIN2, PIN3, PIN5: -12V PIN6: 12V
AC120V
J4
AC
8.4.2 Replacement and Connection Purpose: The power board is one of the key components in the analyzer. If any board problem occurs, it is required to replace or repair the board timely to ensure normal operation of the analyzer. Please use the following procedure to replace the power board. Tool: A 107 cross-head screwdriver and a multimeter. Removal: 1. Shutdown the analyzer and disconnect the AC power cable; 2. Remove the power assembly from the main unit; 3. Open the power housing, remove 4 fastening screws on the power board, and remove the power board from the housing.
Please wear antistatic gloves when removing the board; Please make sure the power is off and disconnect the power cable before removing the boards. Installation: Reverse the removal procedure. Verification: 1. Check if all the screws are installed on the board; 2. Connect the power cable and turn on the AC control switch. Now the analyzer will be initialized, and all the board indicators will be illuminated.
Make sure the power assembly is firmly connected by screws with the main unit. Only perform these removal procedures after the power board and the surroundings are cooled down.
8.4.3 Troubleshooting The troubleshooting procedures for the power board are shown below.
8-27
Hardware System
Figure 8-12 Troubleshooting flowchart of the power board
8.5. Optical Boards 8.5.1 Optical Path and Optical System Workflow
Figure 8-13 shows the schematic diagram of the optical path. The laser is a semiconductor laser with wavelength of 670 nm. The laser irradiates the cells in the flow cell, which generate scattered light. This scattered light intensity is measured by photodiode (PD) from various angles. The measurement signal is then modulated, amplified, and transmitted to analog drive board for further processing. The scatter measured by the photodiode can be divided into three angles: low angle scatter, medium angle scatter and high angle scatter. The type and size of the cell can then be determined by the distribution of scatter intensity on these angles.
8-28
Hardware System
Figure 8-14 Electrical connection diagram of the optical system
Figure 8-14 shows the electrical connection diagram of the optical system. The analog drive board controls the laser. When the PDs detect the light signal, they will transmit current signals through the signal wire to the preamplifier. After I/V conversion, modulation and amplification, the signals will be transmitted through the signal wire to the analog drive board for further processing. A protective microswitch is connected between the analog drive board and the laser analog board. When the optical system housing is opened, the microswitch will be turned off, and the laser will stop working. Therefore, in order to test the laser, press the microswitch manually to connect the electrical circuit (make sure the wire is connected to the “C” pin and “ON” pin of the microswitch).
8.5.2 Functions of Optical Boards SF PD board and FS/SS PD board The SF PD board and FS/SS PD board are mainly used for photoelectric conversion, which converts the light irradiated on the PD to electrical current and transmits the current signal to the preamplifier for further processing.
Preamplifier Overview The preamplifier is mainly used for photoelectric conversion and amplification of the three scatters from the flow cell (forward scatter (FS, also called low angle signal), side medium angle scatter (SS, also called medium angle signal) and side high angle scatter (SF, also called large angle signal)). The FS/SS preamplifier and the SF preamplifier share a common PCB, and achieve the required amplification through welded resistors. Note: LAS and FS refer to low angle signal, MAS and SS refer to medium angle signal, and WAS and SF refer to large angle signal, unless otherwise noted. Corresponding abbreviations refer to the same objects. 8-29
Hardware System Function
The function of the preamplifier includes power modulation, I/V conversion and signal modulation. Power modulation: filters the -12V power supplied by the analog board. The filtered ripples will be less than 50 mV. Signal modulation: converts the current signals to voltage signals by I/V. The signals are then sent to the amplification unit and processed to meet the input requirements of the analog drive board.
Figure 8-15 Functional block diagram of the preamplifier
Laser Control Board Overview
The laser control board controls the laser to provide stable and moderate-intensity laser. Function
The functions of the laser control board include power modulation, laser driving current monitoring and laser power control. Power modulation: filters the ±12V power supplied by the analog board. The filtered ripples will be less than 100mV. Laser driving current monitoring: measures the electrical current of the laser and send the results to the analog board for monitoring. Laser power control: the laser is controlled by a constant power control method. The laser output power is monitored in real time by a photodetector inside the laser. The result forms a loop system by negative feedback to achieve constant output power. The power is controlled within the range of 3 mW~5 mW by adjusting the potentiometer VR1 on the board.
8-30
Hardware System
Figure 8-16 Functional block diagram of the laser control board Adjusting laser driving current: when a laser overcurrent problem is reported, it is usually necessary to adjust the adjustable potentiometer VR1 on the laser analog board to adjust the laser current. when adjusting, observe the laser current changes in the “Voltage and Current” screen in the Analyzer Status screen. If the current does not change and is not zero when VR1 is being adjusted, then either the laser analog board or the laser fails. Otherwise the problem may be caused by wire failure, and it is required to check the wires before adjustment. It is also necessary to adjust the current after replacing the laser analog board to keep the current within the acceptance. The adjusting method is the same with above.
8.5.3 Troubleshooting Table 8-14 Troubleshooting and solutions of optical problems
No.
Symptom
Possible Cause
Solution
1
Laser does
Power/microswitch
1. Check if the connecting wire between the
not work
/laser abnormality
optical system and analog drive board is loose or broken. If loose, reconnect the wire. If broken, replace the wire. Otherwise, proceed to the next step. 2. Check if the microswitch is working properly. Press the microswitch with power off. Measure the continuity between “ON” and “C” pin with a multimeter. If the measured resistance is greater than 10 ohms, replace the microswitch. 8-31
Hardware System
Otherwise, proceed to the next step. 3. Check the power supply of the optical system by measuring the analog drive board at J9.1 (AVSS，-12.6~-11.4V), J9.2 (AVCC， 11.4~12.6V), J9.13 (AVSS，-12.6~-11.4V), J9.17 (AVCC，11.4~12.6V), J9.20 (AVDD， 4.75~5.25V), J9.4~J9.16 (GND). If any measurement is abnormal, check if there is problem in the power board or the analog drive board. Otherwise, proceed to the next step. 4. Check if the analog drive board J9.18 is low. If not, check if the power board and the analog drive board are working properly. 5. If 1 to 4 are all excluded, then the problem is in the power board or the analog drive board. Replace the laser analog board. If the problem persists, replace the optical system. 2
No signal output
1. Check if the connecting wire between the
Power/control signal/other abnormality
optical system and analog drive board is loose or
from FS,
broken. If loose, reconnect the wire. If broken,
SS and SF
replace the wire. Otherwise, proceed to the next
channel
step. 2. Check the power supply of the optical system by measuring the analog drive board at J9.1 (AVSS，-12.6~-11.4V), J9.2 (AVCC， 11.4~12.6V), J9.13 (AVSS，-12.6~-11.4V), J9.17 (AVCC，11.4~12.6V), J9.20 (AVDD， 4.75~5.25V). If any measurement is abnormal, check if there is problem in the power board or the analog drive board. Otherwise, proceed to the next step. 3. Check if the analog drive board J9.18 is low. If not, check if the power board and the analog drive board are working properly. 4. If all the above problems are excluded,
8-32
Hardware System
replace the preamplifier and check if the problem is solved. If the problem persists, replace the optical system.
8.6. Touchscreen Drive Board 8.6.1 Overview The touchscreen drive board provides the interface between the touchscreen and the control board, converting the user's touch operation to identifiable signals for the control board. The touchscreen drive board needs to be adjusted before use.
8.6.2 Components The core of this board is a 4-wire touchscreen control chip TSC2004IRTJR, which communicates with the control board through the I2C interface to transmit the position information of the touch points.
Figure 8-17 Touchscreen connection
8.6.3 Troubleshooting Table 8-15 Troubleshooting and solutions of the touchscreen
No. 1
Symptom The
Possible Cause
Solution
Touchscreen analog
1. Check if the control board is working
touchscreen
board
properly. If not, please solve the control board
will not
failure/Touchscreen
problem first.
respond to
failure/Loose
touch
connection
2. Check if the connecting wire between the touchscreen analog board and the control board is loose or broken. If loose, reconnect the wire. If broken, replace the wire. 3. If the problems in 1 and 2 are excluded, then replace the touchscreen analog board and see if the problem is solved. 8-33
Hardware System
4. After the replacement, if the problem persists, replace the touchscreen. 2
3
The cursor
Loose connection
1. Check if there is any crack on the
can only move
between the
touchscreen. If there is, it will be necessary to
horizontally or
touchscreen analog
replace the touchscreen.
vertically
board and the
when touching
touchscreen/Broken
the screen
touchscreen
The cursor can not move
2. Reconnect the wire between the touchscreen analog board and the touchscreen.
Un-calibrated/Brok en touchscreen
1. Perform touchscreen calibration in accordance with the calibration procedure from the
to certain area
screen (if the deviation is too much between the touch point and the actual cursor position to enter the touchscreen calibration screen, use a USB mouse to enter the screen and start the calibration procedure). 2. If the problem persists, check if the touchscreen is broken. If so, please replace the touchscreen.
8.7. Indicator Board 8.7.1 Overview The indicator board provides the user with sound or light indications to inform the current analyzer status.
Figure 8-14 Indicator Board
8.7.2 Components The indicator board consists of red, yellow and green indicators, control circuits and buzzer drive circuit. The indicator board does not need to be adjusted before use. 8-34
Hardware System
8.7.3 Troubleshooting Table 8-16 Troubleshooting and solutions of the indicator board
No.
Problem
Description
Troubleshooting and solutions
Dim indicator
There are 7 LEDs for each color. A dim color
Type 1
Indicator
indicated some LED(s) of this color is damaged. Remove the indicator board and check if all the 7 LEDs are illuminated. If the number of illuminated LEDs is less than 7, then the board is damaged and needs to be replaced. IF not, please measure the voltage between pin 6 and pin7 at J1 of the indicator board. If the voltage is less than 4.5V, please check if the 5V power supply of the control board is working properly. The indicator is not illuminated.
1. Check if the control board is working properly. If not, please solve the control board problem first; 2. Check if the connecting wire of the indicator board is loose or broken. If loose, reconnect the wire. If broken, it is necessary to replace all the front panel signal wires together. 3. If there is no problem in the wires, please replace the indicator board.
8.8. Motor, Photocoupler and Microswitch 8.8.1 Overview The motor is used for driving assemblies such like sampling assembly and syringe assembly. The photocoupler is used for detecting the motor position. The microswitch is used for starting the blood test process. The schematic diagram of the motor and the photocoupler is shown below.
8-35
Hardware System
8.8.2 Troubleshooting Table 8-17 Troubleshooting and solutions of motor, photocoupler and microswitch
No.
Problem
Description
Troubleshooting and solutions
Type 1
Motor
The motor does 1、 Check the analog drive board. If there is problem with the analog drive board, solve it first. not turn 2、 Check there is any loose or broken wire between the motor and the analog drive board. If there is, replace the corresponding wire. 3、 If there is no problem in the wires, replace the motor. The motor won't stop at the specified position
2
Photocouple
The motor can
r
not move to
1、 Check the analog drive board. If there is problem with the analog drive board, solve it first. 2、 Check there is any loose or broken wire between the photocoupler and the analog drive board. If there is, replace the corresponding wire. 3. If there is no problem in the wires, replace the photocoupler.
certain position
8-36
Hardware System
8.9. Liquid sensor board 8.9.1 Overview The liquid sensor board is used to detect whether there is liquid in the tube, judge whether there is liquid or not by the refractive ratio for the refractive ratio is not the same when there is liquid or not.
Figure 8-15 Liquid sensor board
8.9.2 Composition The main part of the board is photocoupler, there is a LED indicator at the back of the board, if there is not barrier between the photocoupler transmitting tube and receiving tube, the LED light is off; if the photocoupler is blocked, the LED light is on. When testing the board function, use the card to perform photocoupler barrier testing.
8.9.3 Troubleshooting When testing the reagent, if there is reagent, the board TP4 output is low electrical level (lower than 0.8V) and the LED light is off, if there is no reagent, output the high electrical level (higher than 2V) and the LED light is on, when the error occurs, troubleshoot by the LED light status and whether there is reagent at the testing point.
8-37
9 Heating System 9.1. Heating System Overview The heating system consists of diluent heating system and optical heating system. The diluent heating system provides the best temperature range for the RBC bath and the WBC bath. The optical heating system provides the temperature range for normal operation of the optical instruments. The diluent heating system consists of temperature detection assembly and preheat assembly. A diluent sensor and a preheat sensor work together to detect and control the heating temperature of the preheat assembly. The optical heating system consists of power assembly and fan assembly. The optical system is heated by the heat generated by the power board. When the optical system temperature exceeds a specified limit, a temperature sensor inside the Optical System will start the fan assembly, which draws heat from the bottom of the power assembly and controls the temperature of the Optical System. The temperature ranges of each detection point are listed below:
Name
Temperature Range °C
Temperature of the diluent
10~40
detection assembly Temperature of preheat assembly
Variable. A range can be calculated by the diluent temperature
Internal temperature of optical
15~40
system
9.2. Heating System 9.2.1 Diluent Heating System
Structure diagram 1. Temperature detection assembly Symbol:
9-1
Heating System
Appearance:
Function:
a. Determine if the diluent temperature is within [10°C, 40°C]. If not, the analyzer
will stop working and beep; b. provides the diluent temperature to calculate the bath temperature.
2. Reagent preheating unit: Symbol:
Appearance:
Function: perform and control heating of diluent, and detect the bath temperature after heating.
9-2
Heating System
9.2.2 Optical heating system Optical System Temperature Testing Unit
J10 Analog Drive Board
J17 J18 J19
Fan System
Function: Power assembly: continuously heats the optical system; Optical System: detects the temperature and determine whether to work; Fan assembly: cools the optical system. Starts when the optical system temperature is higher than 30℃, and stops when the optical system temperature is lower than 25℃.
9-3
10 Mechanical System 10.1. Mechanical System Overview This section lists the locations of major analyzer components for the service personnel to remove and replace the components. The diagrams in this manual is based on BC-5150. BC-5000 and BC-5150 are basically the same.
Front view
Figure 10-1 Front view of the main unit
1 ---- Display
2 ---- Power/Status indicator
3 ---- Key supporting pad (wipe baffle)
4 ---- Sample probe
5 ---- [Aspirate] key
10-1
Mechanical System
Figure 10-2 Front view of the main unit (cover open)
1 --- Fluidic valve
2 --- Syringe
3 --- Metering pump
4 ---
5 --- Sampling assembly
6 --- Pressure & Temperature testing unit
Back view
10-2
[Aspirate] key
Mechanical System
Figure 10-3 Back view of the main unit
1 --- Diluent Inlet
2 --- Waste Outlet
3 --- Waste sensor
4 --- Power input socket
5 --- Power switch
6 --- Power backplane
7 --- Back panel
10-3
Mechanical System
Figure 10-4 Back view of the main unit (internal structure)
1 --- Analog drive board
2 --- Pinaster board
3 --- Fan assembly
Left view
Figure 10-5 Left view of the main unit
10-4
Mechanical System
1 --- Access door
2 --- Panel Module
3 --- Left door assembly
4 --- Network interface and USB port
Figure 10-6 Left of the analyzer (left door open)
1 --- Left door
2 --- DIFF reagent bottle
3 --- LH reagent bottle
4 --- Front Panel Module
5 --- Network port, USB port
10-5
Mechanical System
Left view
Figure 10-7 Right view of the main unit (right door open)
1 --- Fluid port
2 --- Waste water pump subassembly
3 --- Vacuum chamber assembly
4 --- valve
5 --- Temperature sensor
6 --- Sampling assembly
7 --- Panel Module
8 --- RBC unit
9 --- WBC unit
10.2. Components 10.2.1 Introduction This section provides exploded view of the analyzer and material IDs for the service personnel to understand the relationship between the components when removing and replacing the components. Note
All the material IDs listed in the “Material ID” column of all the parts lists are only used for the service personnel to search the corresponding spare part ID. Please provide the spare part ID when purchasing a spare part.
10-6
Mechanical System
10.2.2 Overall Exploded view
Parts list No.
Material ID
1
Material Description
Spare Part ID
Comments
Panel Module (BC-5150)
/
/
Top Cover (BC-5150)
/
/
Panel Module(BC-5000)
/
/
Top Cover (BC-5000)
/
/
The M3X8 Combination Bolt
/
/
Right Door
/
/
Assembly, Left door
/
/
Main Unit
/
/
115-014325-00 3 1 115-014323-00 3 4
/
2 5
115-015670-00
7 6
/
Screw, Flat Head Phillips M3X6
/
/
8
115-016034-00
DIFF Lyse Cap Assembly
115-016034-00
/
9
115-016035-00
LH Lyse Cap Assembly
115-016035-00
/
10
115-007635-00
801-3201-00053-00
/
M-68D CAP Component for Diluent
11
115-013091-00
Waste Cap assm
115-013091-00
/
12
3102-20-69094
Diluent Assembly holder
801-3110-00167-00
/
10-7
Mechanical System
10.2.3 Main unit Exploded view
10-8
Mechanical System
10-9
Mechanical System
Parts list No.
Material ID
Material Description
Spare Part ID
Comments
1
/
Mainframe
/
/
2
/
syringe assembly
/
See Section 11.2.6
3
115-014601-00
1ml Pump(eject)
115-014601-00
/
4
115-015678-00
Switch assembly
115-015678-00
/
5
/
3-way Valve (Mindray)
801-3201-00003-00
/
6
0030-30-07587
2-way Valve (Mindray)
0030-30-07587
/
115-007667-00
/
mirco solenoid valve of 7
115-007667-00
two-way(higher operating pressure)
8
/
exoteric sampling keystroke
801-3100-00194-00
/
8
043-002703-00
exoteric sampling keystroke
043-002703-00
/
9
/
key support plate
/
/
10
115-014598-00
200ul pump
115-014598-00
/
11
115-017730-00
liquid detect assembly
115-017730-00
/
12
115-015673-00
Vacuum/Pressure Chamber
115-015673-00
/
13
/
RBC isolated washer
/
/
14
/
/
/ /
RBC shielding bottom plate welding piece
15
115-015672-00
Reagent preheating unit
115-015672-00
16
/
RBC count pool module
/
See Section 11.2.8
17
043-000711-00
filter
043-000711-00
/
18
/
Isolation chamber clamp
801-3003-00045-00
/
19
042-007065-00
RBC shielding box
042-007065-00
/
20
/
WBC heat preservation box
/
/
21
115-015676-00
Sample Probe Assembly
115-015676-00
/
22
/
right door
/
/
23
115-014726-00
TAKASAGO value assem
115-014726-00
/
24
/
GHB count pool module
/
LVMvalve assembly
115-015675-00
See Section
25
115-015675-00
26
/
27
115-015677-00
28
115-015680-00
29
/
waste water pump subassembly
11.2.8 / See Section / 11.2.10
Temperature detection assembly
115-015677-00
/ See Section
Power Assembly
15-015680-00
reagent bottle plate cosmetic
/
11.2.13
10-10
/
Mechanical System
No.
Material ID
Material Description
Spare Part ID
Comments
piece 30
115-016034-00
DIFF Lyse Cap Assembly
115-016034-00
/
31
/
Reagent bottle,500ml
/
/
32
/
Reagent bottle,220ml
/
/
33
115-015681-00
Assembly, Left door
/
/
34
115-016035-00
LH Lyse Cap Assembly
115-016035-00
/
35
/
Plate, fixing liquid detect board
/
/
36
051-001621-00
Liquid detect board PCBA
051-001621-00
/
37
043-000829-00
Reagent detection tube
043-000829-00
/
38
/
/
/
Male Lure Lock Ring,For MTLP or LC23,Green 39
/
Plate,fixing liquid fetect board
/
/
40
051-001621-00
Liquid detect board PCBA
051-001621-00
/
41
043-000829-00
Reagent detection tube
043-000829-00
/
42
/
Optical System
115-018419-00
/
43
115-017923-00
assembly, fan
115-017923-00
/
44
/
Assembly, power back plate
/
/
back plate
/
/
/
USB grounging sheet
/
/
/
Conductive Fabric Gasket
/
/
051-001159-00
/
45
See Section 11.2.11
46
47
051-001159-00
Pinaster board(5 ALL_AM1808)
48
/
Analog Drive Board PCBA
115-018411-00
49
115-017477-00
3107 wire assembly
/
/
50
115-017475-00
tube package
/
/
51
023-000549-00
023-000549-00
/
801-3100-00226-00
/
Secure Digital Memory Card 8GB
52
/
Lithium battery 3V 35mAh D12.5*2.0
10-11
Mechanical System
10.2.4 Panel Module (BC-5150) Exploded view
Parts list No.
Material ID
Material Description
Spare Part ID
Comments
1
043-002706-00
BC-5150 front cover
043-002706-00
/
2
045-000016-01
Touch Panel Defend cushion
/
/
3
/
Touch Panel
801-3110-00184-00
/
4
/
screen module(BC-5150)
/
5
/
The M3X8 combination Bolt
/
6
/
touch panel shield box
7
051-000881-00
6301 touch control board PCBA
11
/
115-018418-00
/ /
M4 Strap Natural Nylon Color / 94ULV-2 8
051-000675-00
Indication board PCBA
051-000675-00
/
9
/
shield(5150)
/
/
10
/
/
/
Cross pinhead screw with washer M3X10
10-12
Mechanical System
10.2.5 Panel Module (BC-5000) Exploded view
Parts list No.
Material ID
Material Description
Spare Part ID
Comments
1
043-002705-00
BC-5000 front cover
043-002705-00
/
2
045-000016-01
Touch Panel Defend cushion
/
/
3
021-000005-00
Touch Panel
801-3110-00184-00
/
4
/
screen module(BC-5000)
/
5
/
The M3X8 combination Bolt
/
6
/
Touch panel shield box
7
051-000881-00
6301 touch control board PCBA
11
/
115-018417-00
/ /
M4 Strap Natural Nylon Color / 94ULV-2 8
051-001062-00
Indicator board PCBA
051-001062-00
/
9
/
Shield(5000)
/
/
10
/
/
/
Cross pinhead screw with washer M3X10
10-13
Mechanical System
10.2.6 Syringe Assembly Exploded view
Parts list No.
Material ID
Material Description
Spare Part ID
Comments
1
024-000366-00
Stepping motorSST42D2120
024-000366-00
/
2
/
coupling
/
/
3
/
Rubber Ring + Positioning Sleeve
/
/
4
041-005167-00
special bolt 3
041-005167-00
/
5
115-011902-00
10ml syringe(3107)
115-011902-00
/
6
/
The M3X8 combination Bolt
/
/
7
/
the fixed plate of two injecter
/
/
8
115-012708-00
250ul syringe(with nozzle)
115-012708-00
/
9
/
801-3003-00015-00
/
/
/
/
/
Syringe Motor Position Sensor Assembly
10
/
Screw, Pan Head W/Washer Phillips M3X6
11
/
M3X12 Hexagon socket screws
10-14
Mechanical System
10.2.7 Sample Probe Assembly Exploded view
Parts list No.
Material ID
Material Description
Spare Part ID
Comments
1
/
Elevator Motor(2S42Q-05640A)
801-1805-00013-00
/
2
/
Upper Positioning Sleeve
/
/
3
/
M3X5 Hexagon Socket Set Screw
/
/
4
/
Transducer discreteness
801-3001-00055-00
/
5
/
SCREW M3X4
/
/
6
/
801-3003-00015-00
/
Syringe Motor Position Sensor Assembly
7
/
Lower Positioning Sleeve
/
/
8
/
probe wipe
801-3102-00057-00
/
9
/
/
/
Cross pinhead screw with washer M3X10
10
/
probe wipe clamp
801-3900-00096-00
/
11
/
Sample Probe
801-3101-00002-00
/
12
/
The M3X8 combination Bolt
/
/
13
/
probe press plate
/
/
10-15
Mechanical System
10.2.8 RBC count pool module Exploded view
Parts list No.
Material ID
Material Description
Spare Part ID
1
/
Add liquid connector
Comments /
115-018414-00 2
/
3
/
pool cover
/
M3X6 Stainless Steel Cross Recess /
/
Pinhead Screw 4
/
Count pool support plate
/
/
5
/
Count pool adjusting plate
/
/
6
/
RBC count pool
7
/
Front bath washer
9
/
RBC back pool
8
045-000809-00
Ruby Red Cell Counter(D50um)
/ 115-018412-00
/ /
10-16
045-000809-00
/
Mechanical System
10.2.9 HGB count pool module Exploded view
Parts list No.
Material ID
Material Description
1
/
add liquid connector
Spare Part ID
Comments /
115-018413-00 2
/
3
/
pool cover
/
M3X6 Stainless Steel Cross Recess /
/
Pinheads Screw 4
/
Count pool support plate
/
/
5
/
Count pool adjusting plate
/
/
6
043-002923-00
HGB count pool
043-002923-00
/
7
/
HGB amp module
115-018415-00
/
10-17
Mechanical System
10.2.10 Pump Assembly Exploded view
Parts list No.
Material ID
Material Description
Spare Part ID
Comments
1
/
pump mounting plate
/
/
2
/
The M3X8 combination Bolt
/
/
3
/
Rubber Ring Positioning Sleeve
/
/
4
/
Rubber Ring
/
/
5
/
Rotation (Waste) pump
/ 115-018416-00
6
/
cable of waste pump
/
10.2.11 Power Backplane Assembly Exploded view
10-18
Mechanical System
Parts list No.
Material ID
Material Description
Spare Part ID
Comments
1
/
power back plate
/
/
2
/
LockNut,1/4-28UNF,Red Nylon
/
/
3
/
/
/
/
/
/
/
Lock Nut, Panel Mount,1/4-28UNF,White Nylon 4
/
5
/
Coded Lock Ring, Red Coded Lock Ring, For FTLLB or FTLB,White
6
/
Female Luer,1/4-28UNF,1/8ID
/
/
7
/
BNC socket
/
/
8
/
Screw, Flat Head Phillips M3X6
/
/
9
0030-10-13055
Filter power 115/250VAC6A panel mount 10
M07-00131F---
FUSE Time-lag 250V 3.15AD5X20
10-19
Mechanical System
10.2.12 Optical System Exploded view
Parts list No.
Material ID
Material Description
Spare Part ID
Comments
1
051-001142-00
3107 Preamplifier
051-001142-00
/
2
/
Shield of Preamp PCBA
/
/
3
M07-00143S---
SWITCH
/
/
4
/
SUS316 Flat Washer - A Class 4
/
/
5
/
Laser control board
/
/
6
/
Coverplate of Optics Shield
/
/
10-20
Mechanical System
10.2.13 Power Assembly Exploded view
Parts list No.
Material ID
Material Description
Spare Part ID
Comments
1
/
power cover plate
/
/
2
051-001319-00
3107 Power Source PCBA
051-001319-00
/
3
/
Power bottom plate
/
/
4
/
The M3X8 combination Bolt
/
/
10.3. Removal and Installation 10.3.1 Tools The following tools may be needed during removal and replacement of components: Crosshead screwdriver (107) Flathead screwdriver Tweezers Pliers Cutting pliers Hex wrench set
10.3.2 Preparation for Disassembly Before disassembling the analyzer, please make the following preparations:
10-21
Mechanical System
Stop the blood tests. Adjust the sample probe to the horizontal sampling position. Shut down the analyzer and disconnect all the connections with accessories and peripherals. Disconnect the external power supply.
All the analyzer components and surfaces are potentially infectious. Take proper protective measures for operation and maintenance.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory. If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor. Please eliminate static electricity before disassembly. While removing the components with electrostatic sensitive mark, please wear protective equipment such like an antistatic wrist strap or antistatic gloves to avoid ESD damage to the components. During reassembly, please connect the wires correctly and keep them in proper positions to avoid short circuit caused by damaged wires. Use screws of suitable models during reinstallation. Using wrong screws may result in equipment damage. Furthermore, during usage after reinstallation, a wrong screw may become loose and fall off, resulting in unexpected product damage or personal injury. Please disassemble the equipment in the correct order. Failure to do so may result in irreversible damage to the equipment. Please make sure all connections have been disconnected before disassembling the components. Be careful not to break the wires or the connectors during disassembly. Please store the removed screws and other parts in separate places for reinstallation purpose. Be careful not to drop, contaminate or lose these parts. During disassembly, separate the materials by module to avoid misusing or missing materials during reassembly. During reassembly, please assemble first the components then the main unit. Be careful with the wire connections. Place the wires in proper position.
10.4. Disassembling the Main Unit
During the disassembly, make sure the site is smooth without foreign materials to avoid screen scratches.
10-22
Mechanical System All operations must be done by professionals. Insulating gloves must be worn when servicing. After assembly, check all the fluidic tubes. Folding is strictly prohibited.
10.4.1 Removing the Back plate Place the analyzer flat on the table as shown below. Unscrew the 4 M3×8 combination screws and remove the back plate.
10.4.2 Removing the Analog drive board PCBA 1. Remove the back plate in accordance with Section 10.4.1. 2. Remove the 3 M3×8 combination screws as shown below. Remove the top cover of the shield box and disconnect the RBC_PLT signal wire connector.
3. Remove all the cables from the analog drive board as shown below. Unscrew the 8 M3×8 combination screws and remove the analog drive board.
10-23
Mechanical System
Installation: Reverse the removal procedure. Verification: 1. Check all the connections on the analog drive board and make sure there is no mistakes. 2. Start the analyzer and power on the analog drive board. Check if the analog drive board power and indicators are working properly. 3. Perform blank background count. If no alarm occurs, then the analog drive board is successfully replaced. Otherwise troubleshooting is needed.
10.4.3 Removing the Pinaster board or the SD card 1. Remove the back plate in accordance with Section 10.4.1. 2. Remove all the cables from the Pinaster board as shown below. Unscrew the 6 M3×8 combination screws and remove the analog drive board.
3. As shown below, unscrew the 2 M3×8 combination screws and remove the USB ground plate and conductive foam as a unit.
10-24
Mechanical System
4. Remove the SD card from the board. Installation: Reverse the removal procedure. Verification: 1. Check all the connections on the Pinaster board and make sure there is no mistakes. 2. Start the analyzer and power on the Pinaster board. Check if the Pinaster board power and indicators are working properly. 3. Perform blank background count. If no alarm occurs, then the Pinaster board is successfully replaced. Otherwise troubleshooting is needed.
10.4.4 Removing the power backplate Assembly 1. Remove the power backplate in accordance with Section 10.4.1. 2. Place the analyzer flat on the table as shown below. Unscrew the 4 M3x8 combination screws. Remove the diluent and waste tubes, and cables and ground wires connected with the power board.
10-25
Mechanical System During installation, verify that the ground wire is connected to the correct ground pin properly.
10.4.5 Removing the Fan Assembly 1. Remove the power backplate assembly in accordance with Section 10.4.4. 2. Remove all the cables from the fan as shown below. Unscrew the 2 M3×8 combination screws and remove the fan assembly.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the electrical connections are correct. 3. After startup, press the “
” button from the system menu, select
“Maintenance”→“Self-test”→“Fan Self-test”→click “Spin”. When the “Spin” column displays “spin”, check if the fans on the both sides of the back plate power switch can spin properly. If so, click the “Stop” button and check if the fan is stopped when the “Stop” column displays “stop”.
10.4.6 Removing the Right Panel Place the analyzer flat on the table as shown below. Unscrew the 2 M3x8 combination screws and remove the back plate.
10-26
Mechanical System
10.4.7 Removing the RBC count pool module(FRU) 1. Follow step 1 and 2 in Section 10.4.2 to remove the top cover from the analog board shield box and disconnect the RBC_PLT signal wire connector. 2. Remove the right door in accordance with Section 10.4.6. 3. As shown below, unscrew the 2 M3×8 combination screws and remove the RBC shield box.
4. As shown below, rotate the RBC back pool 90° counterclockwise and remove the RBC back pool. Use tweezers to remove the front bath washer and the Ruby Red Cell Counter(D50um).
10-27
Mechanical System
5. As shown below, rotate the secondary RBC bath 90° counterclockwise and remove the secondary RBC bath. Use tweezers to remove the primary bath washer and the microsensor.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the tube connections and the electrical connections are correct. 3. Verify normal operations by starting the analyzer.
Before removing the reaction bath shield box, please adjust the sample probe position so that the sample probe leaves the shield box. Otherwise the sample probe may bend or hurt the operator. Install the Ruby Red Cell Counter(D50um) so that the concave of the sensor is facing the center of the RBC count pool. pool
10.4.8 Removing the Ruby Red Cell Counter(D50um) 1. Follow step 2 and 3 in Section 10.4.7 to remove the RBC shield box. 10-28
Mechanical System
2. As shown below, cut off the straps which fasten the tube between the reaction bath to the isolation chamber filter. Rotate the secondary RBC bath 90° counterclockwise and remove the secondary RBC bath.
3. As shown below, unscrew the 2 M3 screws which fasten the RBC count pool module. Remove the RBC count pool module. Use tweezers to remove the ront bath washer and the Ruby Red Cell Counter(D50um).
Note: Use angled tweezers to push the Ruby Red Cell Counter(D50um) out from the RBC count pool center
Before removing the reaction bath shield box, please adjust the sample probe position so that the sample probe leaves the shield box. Otherwise the sample probe may bend or hurt the operator. Install the Ruby Red Cell Counter(D50um) so that the concave of the sensor is facing the center of the RBC count pool. pool
10.4.9 Removing the HGB amp module 1. Remove the right door in accordance with Section 10.4.6. 2. As shown below, unscrew the 2 M3×8 combination screws and remove the WBC heat preservation box.
10-29
Mechanical System
3. Follow the steps in Section 10.4.1 to remove the back plate, and disconnect the HGB unit connector. 4. As shown below, unscrew the 2 M3 screws which fasten the pool cover. Remove the lower part of the HGB count pool module. Rotate the bath counterclockwise 90° and remove the HGB amp module.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the tube connections and the electrical connections are correct. 3. Verify normal operations by starting the analyzer.
Before removing the WBC heat preservation box,, please adjust the sample probe position so that the sample probe leaves the shield box. Otherwise the sample probe may bend or hurt the operator.
10-30
Mechanical System
10.4.10 Removing the Liquid detect board PCBA 1. Place the analyzer flat on the table as shown below. Unlock and open the left access door. Loosen the strap which fastens the reagent bottle tubes and move the tubes towards the top end of the reagent bottle plate cosmetic piece. Remove the reagent bottle (with the tubes) and put it away.
2. Unscrew the M3×8 compound screw, remove the liquid sensor board installation kit and PCBA assembly of the liquid sensor board.
3. Remove the pipe and wires of the liquid sensor board and cancel the liquid sensor board PCBA. Note: During the installation, connect the PCBA connector at the square hole to the DIFF reagent pipe, connect the PCBA connector at the round aperture to the LH reagent pipe.
10.4.11 Removing the Reagent Bottle plate cosmetic piece 10-31
Mechanical System
1.Perform step1and step 2 of section 10.4.10, take off the liquid sensor board installation kit and PCBA assembly of the liquid sensor board. 2.Unscrew the 3 M3×8 combination screws and remove the reagent bottle plate cosmetic piece.
10.4.12 Removing the preheat Assembly 1. Follow step 1 and 2 in Section 10.4.9 to remove WBC heat preservation box. 2. As shown below, remove the tubes from the Reagent preheating unit . Unscrew the 2 M3x8 combination screws and remove the Reagent preheating unit . Pull the connector out from the hole. Disconnect the cable connector of the Reagent preheating unit (leave the connector at the left side for installation purpose).
10-32
Mechanical System
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the electrical connections are correct; 3. After startup, press the “
” button from the system menu, select
“Maintenance”→“Temp.& Press. Calibration” and check if the “preheat bath temperature” column is displayed in red. Note: If the wire head retracts back from the hole, please follow the steps in Section 11.4.10 to remove the reagent bottle baffle.
Before removing the WBC shield box, please adjust the sample probe position so that the sample probe leaves the shield box. Otherwise the sample probe may bend or hurt the operator.
10.4.13 Removing the Electromagnet Pinch Valve Assembly 1. Follow step 1 and 2 in Section 10.4.9 to remove the WBC shield box. 2. As shown below, remove the tubes from the pinch valve. Unscrew the 2 M3x12 screws and remove the valve assembly. Pull the connector out from the hole. Disconnect the cable connector of the Reagent preheating unit (leave the connector at the left side for installation purpose).
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the electrical connections are correct; 3. After startup, press the “
” button from the system menu, select 10-33
Mechanical System
“maintenance”→“Self-test”→“Valve Self-test” and click on valve 18 to see if it is working correctly. Note: If the wire head retracts back from the hole, please follow the steps in Section 11.4.10 to remove the reagent bottle plate cosmetic.
Before removing the WBC shield box, please adjust the sample probe position so that the sample probe leaves the shield box. Otherwise the sample probe may bend or hurt the operator.
10.4.14 Removing the Right Valve Assembly 1. Remove the right door in accordance with Section 10.4.6. 2. As shown below, remove the tubes from the valve which needs service. Unscrew the 2 M3x12 screws and remove the valve assembly. Pull the connector out from the hole. Disconnect the cable connector of the Reagent preheating unit (leave the connector at the left side for installation purpose).
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the tube connections and the electrical connections are correct. 3. After startup, press the “
” button from the system menu, select
“maintenance”→“Self-test”→“Valve Self-test” and click on the number (which is printed on the fluidics separator) to see if the corresponding valve is working correctly. Note: If the wire head retracts back from the hole, please follow the steps in Section 11.4.10 10-34
Mechanical System
to remove the reagent bottle plate cosmetic.
10.4.15 Removing the Pump 1. Remove the right door in accordance with Section 10.4.6. 2. As shown below, remove the tubes from the pump. Unscrew the 4 M3x12 screws and washers and remove the pump assembly. Pull the connector out from the hole. Disconnect the cable connector of the Reagent preheating unit (leave the connector at the left side for installation purpose).
4. As shown below, unscrew the 4 M3×8 combination screws and remove the pump.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the tube connections and the electrical connections are correct. 10-35
Mechanical System
3. Verify normal operations by starting the analyzer. Note: If the wire head retracts back from the hole, please follow the steps in Section 11.4.10 to remove the reagent bottle baffle.
10.4.16 Removing the Vacuum Chamber Assembly 1. Remove the right door in accordance with Section 10.4.6. 2. Remove the tubes from the vacuum chamber. Unscrew the 2 M3×8 screws and remove the vacuum chamber assembly.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the tube connections and the electrical connections are correct. 3. After startup, press the “
” button from the system menu, select
“Status”→“Temp.& Pressure” and check if the “Vacuum” column is displayed in red. 4. Verify normal operations by starting the analyzer.
10.4.17 Removing the Top Cover As shown below, unscrew the 2 M3×8 screws. Lift and remove the top cover from the rear edge.
10-36
Mechanical System
10.4.18Removing the Temperature detection assembly 1. Remove the top cover in accordance with Section 10.4. 17. 2. Remove the cable connectors from the temperature detection assembly.
Installation: Reverse the removal procedure. Verification: 1. Verify the tube connections and the electrical connections are correct. 2. After startup, press the “
” button from the system menu, select
“Status”→“Temp.& Pressure” and check if the “Diluent temperature” column is displayed in red.
10.4.19 Removing the Sampling Probe Assembly 10-37
Mechanical System
1. Remove the right door in accordance with Section 10.4.6. 2. Follow the steps in Section 11.4.17 to remove the top cover, and disconnect the cable connectors of the motor and the upper/lower sensors from the sample probe assembly. 3. As shown below, remove the tubes from the sample probe. Unscrew the 4 M3×12 screws and washers, and remove the sample probe assembly.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the tube connections and the electrical connections are correct. 3. After startup, press the “
” button from the system menu, select
“Maintenance”→“Sample Probe Debug” to verify the three posiaons of the sample probe (“Initial position”, “Up"," Middle position” and “Down position” of “RBC bath” and “WBC bath”) and ensure the reliable operation of the sample probe. 4. Verify normal operations by starting the analyzer.
10.2.20 Replace the Horizontal Motor of the Sampling Probe Assembly 1. Remove the sample probe assembly in accordance with Section 10.4.19. 2. As shown below, first remove 2 set screws, then remove the 4 M3×10 screws, the Lower positioning sleeve and the motor.
10-38
Mechanical System
10.4.21 Replace the Vertical Motor of the Sampling Probe Assembly 1. Remove the sample probe assembly in accordance with Section 10.4.18. 2. As shown below, unscrew the 1 M3×4 screw and remove the Transducer discreteness.
3. As shown below, first remove 2 set screws from the fixing hole, then remove the 4 M3×10 screws, the Upper positioning sleeve and the motor.
10.4.22 Removing the Probe wipe 1. After startup, press the “
” button from the system menu, select
“Maintenance”→“Sample Probe Debug”. Click on the “Initial position”, the “RBC bath”， then click on the “Up” to adjust the sample probe to above the RBC bath. 10-39
Mechanical System
2. Follow step 1 and 2 in Section 10.4.7 to remove the right panel and the RBC shield box. 3. As shown below, remove the probe wipe clamp and the Probe wipe. Disconnect the tube from the Probe wipe.
Installation: Reverse the removal procedure. Verification: 1. Verify the tube connection is correct. 2. After startup, press the “
” button from the system menu, select
“Maintenance”→“Sample Probe Debug” to verify the three posiaons of the sample probe (“Initial position”, “Up", "Middle position” and “Down position” of “RBC bath” and “WBC bath”) and ensure the reliable operation of the sample probe. 3. Start the analyzer and perform the sample probe cleaning sequence. Check if any fluid flows out from the bottom of the wipe.
10.4.23 Replacing the Sample Probe 1. After startup, press the “
” button from the system menu, select
“Maintenance”→“Sample Probe Debug”. Click on the “Initial position”, the “RBC bath”， then click on the “Up” to adjust the sample probe to above the RBC bath. 2. Remove the probe wipe in accordance with Section 10.4.22. 3. As shown below, remove the tubes from the sample probe. Remove the M3 screws and the probe press plate, and remove the sample probe.
10-40
Mechanical System
Installation: Reverse the removal procedure. Verification: 1. Verify the tube connection is correct. 2. After startup, press the “
” button from the system menu, select
“Maintenance”→“Sample Probe Debug” to verify the three positions of the sample probe (“Initial position”, “Up"," Middle position” and “Down position” of “RBC bath” and “WBC bath”) and ensure the reliable operation of the sample probe.
10.4.24 Removing the Syringe Motor Position Sensor 1.
Place the analyzer flat on the table. Follow the steps in Section 10.4.10 to remove the
reagent bottle cosmetic piece, and disconnect the cable connectors of the photocoupler assembly of the sampling assembly motor. 2. As shown below, unscrew the 4 M3×4 screws and remove the Syringe Motor Position Sensor Assembly.
10-41
Mechanical System
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the electrical connections are correct; 3. After startup, press the “
” button from the system menu, select
“Maintenance”→“Sample Probe Debug”→“Iniaal posiaon” so that the sample probe goes back into the initial position. Then click on “RBC bath” and “WBC bath” respectively to verify normal operations of the sample probe. 4. Verify normal operations by starting the analyzer.
10.4.25 Removing the transducer discreteness 1. Follow the steps in Section 10.4.17 to remove the top cover, and disconnect the cable connectors from the photocoupler assembly of the sample probe assembly motor. 2. Remove the right door in accordance with Section 10.4.6. 3. Move the sample probe by hand to above the WBC bath. Cut the strap fastening the sensor assembly with diagonal pliers and remove the cable connectors. 4. Move the sample probe by hand to the front side. As shown below, unscrew the M3×4 screws, and remove the sensor assembly from the front side.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the electrical connections are correct; 3. After startup, press the “
” button from the system menu, select
“Maintenance”→“Sample Probe Debug”→“Iniaal posiaon” so that the sample probe goes back into the initial position. Then click on “Up”, “Middle position” and “Down position” 10-42
Mechanical System
respectively to verify normal operations of the sample probe. 4. Verify normal operations by starting the analyzer.
10.4.26 Removing the Panel Module 1. Place the analyzer flat on the table. Unlock and open the left access door. 2. Remove the right door in accordance with Section 10.4.6. 3. Remove the top cover in accordance with Section 10.4.17. 4. As shown below, unscrew the 6 M3×6 flathead screws. Remove the Panel Module and place it flat on the table.
5. Follow the steps in Section 10.4.1 to remove the back plate, and disconnect the cable connectors of the Panel Module from the Pinaster board. 6. Follow the steps in Section 10.4.10 to remove the reagent bottle baffle. Move the front cover signal wire from the back to the front and remove it.
Note: During installation, the excess part of the signal wire shall be completely inserted into the analyzer. Failure to do so will result in signal interference.
10.4.27 Removing the Indicator board PCBA 1. Follow step 1-4 in Section 10.4.26 to remove the top cover, and put it on the table. Remove the cable connector from the indicator. 2. As shown below, unscrew the 2 M3×10 screws and remove the indicator board cover and the indicator board PCBA.
10-43
Mechanical System
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the cable connections are correct; 3. Start the analyzer and verify the indicators can be illuminated.
10.4.28 Removing the 6301 touch control board PCBA 1. Follow step 1-4 in Section 10.4.26 to remove the top cover, and put it on the table. Remove the cable connector from the touchscreen drive board. 2. As shown below, unscrew the 2 M3×8 combination screws and remove the Touch panel shield box.
3. As shown below, remove the cables from the touchscreen. Unscrew the 2 M3×8 combination screws and remove 6301 touch control board PCBA.
10-44
Mechanical System
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the cable connections are correct; 3. Start the analyzer and verify normal operations of the touchscreen.
10.4.29 Removing the Touch Panel 1. Follow step 1 and 2 in Section 10.4.28 to remove the shield box and disconnect the cables. 2. As shown below, unscrew the 6 M3×8 combination screws which fasten the LCD Module, and remove the Touch Panel (without disconnecting the cables).
3. Remove the touchscreen from the front cover. Installation: Reverse the removal procedure. Verification: 1. Check if each connecting wire between the LCD Module and the Pinaster board is locked. 2. Check if all the components are installed and fastened in position. 3. Calibrate the touchscreen. 4. Start the analyzer and verify normal operations of the touchscreen. 10-45
Mechanical System
10.4.30 Removing the LCD Module 1. Follow step 1-4 in Section 10.4.26 to remove the top cover, and put it on the table. Cut all the straps fastening the screen assembly with diagonal pliers. 2. Follow step 1 and 2 in Section 10.4.28 to remove the Touch panel shield box and disconnect the cables. 3. As shown below, unscrew the 6 M3×8 combination screws which fasten the LCD Module, and the 2 screws which fasten the strap. Remove the LCD Module and disconnect all the cables from the screen.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the cable connections are correct; 3. Start the analyzer and verify that the screen is working correctly.
10.4.31 Removing the Microswitch Assembly 1. Follow step 1-4 in Section 10.4.26 to remove the top cover, and put it on the table. 2. Remove the back plate in accordance with Section 10.4.1. Disconnect the connections from the microswitch. 3. As shown below, unscrew the 2 M3×4 screws and remove the exoteric sampling keystroke and the key support plate as a unit.
10-46
Mechanical System
4. As shown below, unscrew the 2 M3×8 combination screws and remove the microswitch from the small hole in the front panel.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the cable connections are correct; 3. The Start key can be pressed down and released normally with an audible “click”. 4. Verify normal operations by starting the analyzer.
10.4.32 Removing the Syringe 1. Follow step 1-4 in Section 10.4.26 to remove the top cover, and put it on the table. 2. Remove the tubes from the syringe assembly. 10-47
Mechanical System
3. As shown below, unscrew the 4 M3×12 screws and flat washers. Remove the syringe assembly and remove the cables from the syringe.
4. As shown below, unscrew the 3 M3×8 combination screws and special bolt 3, then remove the syringe.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the cable connections and the tube connections are correct; 3. Verify normal operations by starting the analyzer.
10.4.33 Removing the Syringe Motor 1. Follow step 1-3 in Section 10.4.32 to remove the syringe assembly. 2. As shown below, first remove the 2 M3×12 hex screws which lock the coupler, then remove the 4 M3×12 hex screws which fasten the motor. Finally, remove the motor.
10-48
Mechanical System
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the cable connections and the tube connections are correct; 3. Verify normal operations by starting the analyzer.
10.3.34 Removing the Syringe Motor Position Sensor Assembly 1. Follow step 1-3 in Section 10.4.30 to remove the syringe assembly. 2. As shown below, unscrew the 2 M3×6 screws which lock the coupler, and remove the motor position sensor assembly.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the cable connections and the tube connections are correct; 3. Verify normal operations by starting the analyzer.
10.4.35 Removing the liquid detect assembly 1. Follow step 1-4 in Section 10.4.26 to remove the top cover, and put it on the table. 10-49
Mechanical System
2. Remove the tubes from the hydraulic detection assembly, and disconnect the cable connections from the top. 3. As shown below, unscrew the 2 M3×8 combination screws and remove the liquid detect assembly.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the tube connections and the electrical connections are correct. 3. Verify normal operations by starting the analyzer.
10.4.36 Removing the Electromagnetic Pump/Valve from the Front Panel 1. Follow step 1-4 in Section 10.4.26 to remove the top cover, and put it on the table. 2. Remove the tubes from the assembly. 3. As shown below, unscrew the 2 M3x8 combination screws and remove the electromagnetic pump/valve. Pull the connector out from the hole. Disconnect the cable connectors (leave the connectors at the left side for installation purpose).
10-50
Mechanical System
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the tube connections and the electrical connections are correct. 3. Verify normal operations by starting the analyzer.
10.4.37 Removing the Left Door Assembly 1. Place the analyzer flat on the table. Unlock and open the left access door. 2. As shown below, unscrew the 2 M3×8 combination screws and remove the left door assembly.
Note: When installing the left door assembly, the hook at the bottom of the left door shall engage the bottom plate so that the access door in the left door will not swing.
10-51
Mechanical System
10.4.38 Removing the Optical System Please refer to Section 6.4.2 Replacement of the Optical System.
10.4.39 Removing the Optical System Cover 1. Remove the left door assembly in accordance with Section 10.4.37. 2. Remove the top cover in accordance with Section 10.4.17. 3. As shown below, unscrew the 4 M3×8 combination screws and remove the top cover of the optical system shield.
4. Please refer to Section 6.4 Maintenance of the Optical System.
10.4.40 Replacing the RBC/WBC Isolation Chamber Filter 10-52
Mechanical System
1. Follow step 1 and 2 in Section 10.4.7 to remove the right panel and the RBC/WBC shield box. 2. As shown below, unscrew the 1 M3×8 screw. Remove the clip on the chamber and disconnect the tubes from the filter. Remove the isolation chamber filter.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the tube connections are correct; 3. Verify normal operations by starting the analyzer.
10.4.41 Replacing the Power Board PCBA 1. Remove the left door assembly in accordance with Section 10.4.37. 2. Remove the top cover in accordance with Section 10.4.17. 3. Remove all the cable connections from above the power box and place the DIFF reagent bottle in a front position on the table. 4. As shown below, unscrew the 2 M3×8 combination screws Remove the power box assembly and disconnect the connecting wires of the power socket from inside.
10-53
Mechanical System
5. As shown below, unscrew the 2 M3×8 combination screws on both sides and remove the cover plate.
6. As shown below, unscrew the 4 M3×8 combination screws on both sides and remove the power board PCBA.
Installation: Reverse the removal procedure. Verification: 1. Check if all the components are installed and fastened in position. 2. Verify the cable connections are correct;
10-54
Mechanical System
3. Verify normal operations by starting the analyzer.
10-55
11 Troubleshooting Repair Guide Error
Error
Trigger
Related
Potential
Code
Mechanism
Factors
Failure
Related Screen
Comm 0x0100 unicatio
0001
n failure
1. Serial communicati
Analog drive
Damaged
board
communicatio
on protocol error.
/
2. No header,
between the digital board J81 and the analog drive board J31.
Damaged
For regular problems:
communicatio
jumbo
n module
1. Check the connection
frames, insufficient
Connection
frame length,
between the
checksum
control board
error,
For occasional problems: 1. Check the connection
n module Control board
Troubleshooting Procedure
between the control board J81
Loose wire
and the analog drive board J31. 2. Replace the related boards.
J81 and the
unrecognizabl analog board J31 e command Control 0x0100 board failure
0002
AD is not
Control board
within
Analog drive
&
board
Current
[2.44-2.55]
/
Power board and connecting wires
Voltage
1. Check if the parameters are within normal ranges in the Voltage & Current Status screen
Status
2. If so, replace the control
screen
board 3. Otherwise, check if the power board and connecting wires and the connection between the analog drive board J2 and control board J86 are normal 4. If so, replace the analog drive board
11-1
Troubleshooting
System clock
0x0100 0004
failure
Check the
Button battery
/
/
1. Check if the button battery is
system clock
installed on the digital board
is earlier than
2. If the battery is installed,
January 1, 2000
Control board
replace the battery and reset date
/
and time in the Setup screen. Save and exit and reset the analyzer 3. If the problem persists, replace the control board /
Diluent 0x0100
The diluent
Reagent
is used
level is lower
information
Setup
Reagent Setup screen
setup
screen
2. Verify there is sufficient
0104
up
than 4%
Reagent
1. Verify there is no alarm in the
reagent in the diluent tank
LH lyse 0x0100 is used
0105
up
The LH lyse level is lower than 10%
Reagent
1. Metering
Reagent
information
pump failure
Setup
Reagent Setup screen
setup
2. Leaking or
screen
2. Verify there is enough reagent
folding lyse DIFF
0x0100
The DIFF
lyse is
0106
lyse level is
used up
1. Verify there is no alarm in the
in the reagent tank
related tubes and valves
lower than 3%
Waste
0x0100
level is
0110
Float status
Waste sensor
Unable to
Sensor
1. Check if the indicated
assembly
change the
Status
information is as expected from
status
11-2
Troubleshooting
full
correctly due
screen
to foreign
the Sensor Status screen 2. Check if the connecting wire
matter on the
of the waste sensor is correct
float
3. Check if the float is able to change the status correctly
BNC connector of the waste sensor is not connected Power
0x0100
failure
0201
56V power is
Power board
Damaged
power board & Current
not within [47, 60]
0x0100
12V power is
0202
not within
Voltage
Power cable
Unreliable
1. Check if the Voltage & Current Status screen shows
Status
expected information
screen
2. Check if the voltage at the test port of the related power
power cable
board is as expected
[11.5, 12.5] 0x0100
-12V power
Analog drive
Damaged
0203
is not within
board
board
3. Check if the connection between the power board and the analog drive board is normal
[-12.5, -11.5]
4. Check if there is no short 0x0100 0204
P12V power Peripherals and Short circuit
circuit in analog peripherals,
is not within
connection power drive
connections
[11.5, 12.5]
tempera
/
connections
/
0x0100
P24V power
0205
is not within
5. Replace the analog drive
[22.0, 29.0]
board
preheat 0x0100 bath
peripherals and their respective
0401
The preheat
preheat bath
bath temperature
ture
reading at the
sensor
analog drive
failure
board is 0 or 70
Temperature
Damaged
Temp.&
1. Verify the corresponding
temperature
Pressure
temperature value from the
sensor
Status
Status screen
screen
2. First, check if the ambient
Loose wire
temperature is overheating
sensor
3. If the temperature reads “0”,
connection
11-3
Troubleshooting
Optical 0x0100
The optical
assembl
assembly
0402
y
Optical system
temperature
tempera
reading at the
ture
analog drive
sensor
board is 0 or
failure
70
Diluent 0x0100
The optical
tempera
assembly
0403
ture
temperature
sensor
reading at the
failure
analog drive
Damaged
the temperature sensor is
temperature
shorted. Replace related components
sensor Temperature
4. If the temperature reads “70”,
Loose wire
the temperature sensor is open.
sensor
First check for an unreliable
connection
connection, then replace related
Temperature
Loose wire or
sensor
damaged
connection
temperature
components
sensor
board is 0 or 70 preheat 0x0100
After startup,
assembl
the preheat
0404
y failure
preheat
Damaged
assembly
heater
bath
Status screen
then there is an assembly failure
temperature
rises less than
2. If the problem persists after
sensor
1 degree per
preheat bath temperature is less than 35℃ or greater than 55℃,
Damaged
temperature
1. Enter the Status screen. If the
reconnecting the wires, replace
minute for
Damaged
consecutive 3
the preheat assembly
temperature
minutes
switch Assembly
Loose wire
related connections Laser
0x0100
failure
0809
Laser current Optical system is not within [20, 70]
Damaged
Voltage
laser
& Current
Laser drive
Damaged
board
board
1. First, check for an abnormal laser current from the Status
Status
screen
screen
2. Open the optical system shield box and turn the box
Optical system
Damaged shield box 11-4
switch on and off manually. If
Troubleshooting
switch
the laser is not illuminated, check in turn if the connections
Optical system
Loose wire
of optical system, box switch
related
and laser are reliable. If there is
connections
no connection problem, check if the laser drive board and analog drive board are working properly according to the hardware troubleshooting procedures. 3. If the laser is illuminated properly, then check if the laser drive board is working properly according to the hardware troubleshooting procedures. Otherwise, replace the optical system. 4. If the laser is damaged, replace the optical system
Syringe
/
Photocoupler
Damaged
System
1. Confirm the problem from
assembl
photocoupler
Self-test
the System Self-test screen
y failure
or dirty
2. Check the wires, the
surface
photocoupler, the motor and
Syringe motor
Damaged motor
Related
Loose wire
connections Drive
Movement
mechanism
limited by mechanical interference or other causes
11-5
motion interference
Troubleshooting
/
Sampli ng
/
Vertical photocoupler
assembl
Lifting motor
y lifting
System
1. Confirm the problem from
Self-test
the System Self-test screen 2. Check the wires, the
/
photocoupler, the motor and
mechan
Mechanical
Motion
ism
stop
interference
Related
Loose wire
failure
motion interference
connections /
Sampli ng
/
Horizontal photocoupler
assembl
Self-test
the System Self-test screen 2. Check the wires, the photocoupler, the motor and
motor
swingin
motion interference
g
Mechanical
Motion
mechan
stop
interference
Related
Loose wire
ism failure
connections
Backgr 0x0100 ound
1. Confirm the problem from
/
Deflecting
y
System
0702
abnorm
Background
Reagent
unqualified at
contaminated
startup
ality
1. Verify the reagent quality
Reagent
2. If the background PLT is too
or expired Analyzer tubes
high, verify the impedance channel shield (please refer to
Abnormal
the treatment of impedance
shutdown
channel signal interference Bad
alarm)
maintenance
3. Verify the cleanness of the
practice
reaction bath and correct maintenance practice 4. Check there is no leaks in tube connections and valves
HGB blank
0x0100
HGB voltage WBC reaction in not within
There is
Voltage
foreign matter & Current
11-6
1. Check there is no foreign
Troubleshooting
voltage
0801
[3.2, 4.9]
bath
abnorm
in the bath The bath is
al
Status
matter in the WBC bath
screen
2. Check the bath is correctly filled with reagent
not filled with
3. Verify the HGB blank voltage
diluent while
from the Voltage & Current
measuring Analyzer setup
Status screen
HGB gain
4. Verify the HGB gain settings
setup incorrect HGB assembly
5. Check the HGB assembly
Damaged HGB assembly
Fluid
0x0100
pressure
0803
overloa d
MCU reports
Hydraulic
Related tubes
absolute
sensor related
folded
pressure
tubes
Valve
above 320
Status screen
Status screen
failure Optical system
close to current local atmospheric pressure from the
blockage or
kPa
1. Check if the fluid pressure is
2. Check there is no folding tube, blocked or broken valve in
Severely
analyzer tubes
blocked
3. Check if there is obstruction Hydraulic
Loose
sensor and
connection or
connection
damaged
in the sample probe or optical system 4. Check if there is loose
sensor
connection in hydraulic sensor and its connecting wire
Abnor
0x0100
mal
0804
vacuum
Vacuum is
Waste pump
not within the
Dirt blockage or failure
range
Status screen
1. Enter the Status screen. Check if the pressure building process is normal (e.g. if the
specified by
Related
Dirt blockage
the sequence
solenoids
or failure
Related tubes
Leakage
waste pump is working properly) 2. Check if the pressure can be maintained from the Status screen. If not, check if there is
Analog drive
Damaged 11-7
gas leaking in related tubes or
Troubleshooting
board
board
valves; 3. If pressure building fails, check if the waste pump fails or if the tubes are leaking 4. If the waste pump is not working properly, check if the related connection and the analog drive board is working correctly
Abnor
0x0100
preheat bath
Temperature
Loose wire or
mal
0805
temperature
sensor
damaged
tempera
out of range
connection
temperature
temperature is as expected from
ture of
[expected
sensor
the Status screen. Determine if
preheat
temperature
the abnormal status is caused by
-1.5, expected
too great temperature difference
temperature
during diluent replacement
+3]
(recoverable, not a problem)
bath
Status
1. Check if the preheat bath
screen
temperature and the diluent
2. Solve the problem of the sensor according to Temperature Sensor Failure Refer to preheat Assembly Failure
preheat assembly High
0x0100
analyze
0806
r tempera ture
Optical
Fan assembly Damaged fan
Status
or loose wire
screen
temperature is above 40℃
Analyzer air
Air
inlet/outlet
inlet/outlet blockage
1. Check if the optical system temperature is as expected from the Status screen 2. Check if the fan assembly is working correctly (check for fan assembly damage or analog
Optical system Loose wire or damaged temperature sensor
11-8
drive board damage), and if the air inlet/outlet is blocked 3. Solve the problem of the
Troubleshooting
log drive board
sensor according to Temperature
Damaged
Sensor Failure
board Diluent 0x0100
Diluent
tempera
temperature
080C
ture
above 40℃
above upper
Fan assembly Damaged fan
Status
or loose wire
screen
Ambient
Room
Temperature
temperature
temperature is as expected from the Status screen 2. Check if the fan assembly is working correctly, and if the air
too high
limit
1. Check if the diluent
inlet/outlet is blocked Temperature
Loose wire or
sensor
damaged
connection
temperature
3. Solve the problem of the sensor according to Temperature Sensor Failure
sensor
4. Check if the ambient temperature is within the specified operation temperature range of the product Diluent 0x0100
Diluent
tempera
temperature
080D
ture
below 10℃
below lower
Ambient
Temperature
Temperature
too low
Diluent
Temperature
temperature
too low
Status screen
1. Check if the diluent temperature is as expected from the Status screen 2. Solve the problem of the sensor according to Temperature
limit
Sensor Failure 3. Check if the ambient temperature is within the specified operation temperature range of the product
Blocka 0x0100 ge
0901
Aperture
RBC bath
Aperture
System
voltage is too
assembly
blockage or
Self-test
high (24V) or changes dramatically
bad connection between primary bath and secondary
11-9
/
Troubleshooting
bath Apertur 0x0100 e
0902
voltage
Aperture
Aperture
voltage below 17V
is too
(temperature
low
corrected)
Wrong
System
1. Run aperture voltage test
aperture
Self-test
from the System Self-test screen
specification Diluent
Loose wire or
temperature
damaged
sensor
temperature
assembly
sensor
to verify low aperture voltage 2. If the aperture has been replaced, check if there is wrong aperture specification, installation problem or cracked aperture 3. Troubleshoot the temperature sensor according to Diluent Temperature Sensor Failure
Impeda 0x0100 nce
0903
channel
PLT noise
RBC bath
Loose shield
proportion
assembly
wire
RBC bath
Loose shield
shield box
box
Lab
Unreliable
electromagneti
ground
c environment
connection
Analog drive
Loose
board
impedance
over 10%
signal interfer ence
/
/
/
1. Problem 1: Clean the flow
channel shield box Abnor
0x0100
mal
0904
optical
Abnormal
Flow cell
Dirt blockage
sample
cell
stream
2. Problem 2: Replace the
system
optical system
signal
11-10
12 Debug 12.1 Mechanical Position Adjustment Figure 1.1
Tooling Fixture
Materials Consumables
Operation Procedure 1.1 1.2
Figure 1.2
Figure 1.3
1.3
Operation Content Click on “Service → Sample Probe Debug”. Enter the Debug screen as shown in Figure 1.1. First, click on the “Initial position” so that the sample probe is above the RBC bath, as shown in Figure 1.1. Click on the “WBC bath”(or “RBC bath”) button from the screen shown in Figure 1.1. Click the “Middle position” button so that the probe wipe is shown. Check if the sample probe is basically in the center of the bath. If there is any deviation, loosen the four screws shown in Figure 1.3 and slightly adjust the bath in left/right and front/back directions so that the sample probe is in the center of the bath. Then tighten one screw in each direction.
Quality Control QC Point
Adjust the sample probe position Fine tuning of the relative position between the sample probe and the reaction bath
QC Standard
The sample probe is basically in the center of the bath
Adjustment screw for front and back position Adjust ment screw for left and right positio n
Note: 1. In Figure 1.1, before clicking on Initialization, all the buttons except the “Initialization” button will be grey. Only after clicking on Initialization, the three buttons in the “Sample probe horizontal position” column will be illuminated and available for use. The “Middle position” and “Down position” buttons will not be available until clicking on the “WBC bath” or “RBC bath” button.
12-1
Debug
12.2 Commissioning of detection elements 12.2.1 Calibrate and verify the preheat temperature Process
Temperature Calibration
Figure 2.1 Materials
Tooling Fixture
Operation Procedure
2.1
Machine measurement value
Fill in the sum of the machine measurement value and the FRU value
2.2
12-2
Operation Content Click the Start Menu bar, then click “Service→ Temp.& Press. Calibration” to enter the “Temperature calibration” screen. Click on the “Preheat bath temperature calibration” button to enter the screen shown in Figure 2.1 Record the machine measurement value, and enter the sum of the machine measurement value and the value on the service FRU as the meter measurement value
Quality Control QC Point
Measure the preheat bath temperature calibration factor
QC Standard
Debug
12.2.2
Counting channel measurement
Figure 3.1
Tooling Fixture
Crosshead screwdriver
Operation Procedure 3.1
3.2
3.3
Operation Content Open the reaction bath shield box, run several blank counts in the “WB-CBC+DIFF” mode. Ensure that there is no gas bubble in the sample tube and no fluid residue in the sample probe during a complete count. Otherwise, replace the sample tube. Check there is no gas in the sample supply tube and no bubble in the WBC/RBC bath related tubes. Check if the fluid level of the WBC and RBC reaction bath is normal during the whole count process; if the probe tip is below the fluid level every time the probe enters the bath; if there is any splash or bubble when adding fluids; if the bubbles contact with the filling tube; if the WBC and RBC bath can be drained correctly.
12-3
Materials
Quality Control QC Point
QC Standard
Sample tube, sample probe, DIFF bath
No gas bubble in the sample tube, no fluid residue in the sample probe, no gas in the sample supply tube and no bubble in the related tubes.
WBC and RBC reaction bath
There is no splash when WBC or RBC bath is filled; bubbles can be correctly generated; bubbles do not contact with the filling tube; the probe tip is below the fluid level every time the probe enters the bath; the WBC and RBC bath can be correctly drained; no fluid residue is on the bath wall.
Debug
3.4
3.5
3.6
Click “Service→Self-test” from the main menu bar to enter the “Self-test” screen, as shown in Figure 3.1. Click on the “Aperture voltage” button and record the date generated in the Status Screen in the record sheet Installed the shield cover with M3×8 stainless steel panhead combination screws and tighten the screws with a crosshead screwdriver. Run a count again and observe the sample probe assembly during the whole process. The sample probe shall not interfere with the shield box while the reaction bath is mixing.
Aperture voltage
Aperture voltage is normal and no alarm is triggered.
Tighten the screws
The relative position between the sample probe and the reaction bath shield box
The relative position between the sample probe and the reaction bath shield box
Note: The above-mentioned “gas bubble” refers to big bubble which separates the fluid in the tube.
12-4
13 Commissioning and Verification After Servicing Component Name
Material ID
Commissioning
Items
Requirements After Replacement Pinaster board(5
051-001159-00
ALL_AM1808)
1. Perform data
Version
backup according to
information is
the prompts
correct
2. Check the corresponding version information from the “Version Info.” screen Analog Drive Board
115-018411-00
1. Perform HGB gain calibration
HGB blank voltage is 4.5V
2. Recalibrate the MCV gain Syringe transfer assembly
115-020624-00
10ml syringe
115-011902-00
Optical Sensor block of
3101-20-68304
Recalibration
Verify the reproducibility
injector special bolt 3
041-005167-00
10ml syringe FRU
115-015338-00
250ul syringe(with
115-012708-00
nozzle) Stepping motor
024-000366-00
Sampling Assembly
115-015676-00
Elevator
801-1805-00013-
Motor(2S42Q-05640A) Rotation Motor Position Sensor Assembly sensor package
sampling assembly horizontally and
00 801-3003-00015-
vertically to ensure that the sample line is
00 801-3001-00055-
unobstructed with no folding and
00 Ф1.5 mop FRU
1. Move the
801-3102-00057-
13-1
interference with the
Verify the reproducibility
Commissioning and Verification After Servicing
00 Sample Probe(for BC-5300 only)
pre-amplifier, fluidics
801-3101-00002-
separator, right door, motor, valves and line
00
straps 2. Ensure the sample line is not squeezed or deformed at the line straps 3. Ensure there is no folding or interference when the wipe fluid line is moving horizontally or vertically in the sample assembly 4. Mechanical commissioning of the relative position between the sample probe and the WBC/RBC bath 5. Recalibration RBC cound pool
115-018412-00
module(FRU)
1. Mechanical commissioning of the relative position between the sample probe and the bath 2. The waste line for the reaction bath needs to be wrapped in the vertical direction to a height above the liquid level with 3mL of liquid in the bath 3. Perform HGB gain
13-2
Verify the reproducibility
Commissioning and Verification After Servicing
calibration 4. Recalibration HGB cound pool module
115-015987-00
1. Mechanical commissioning of the relative position between the sample
1. Verify the reproducibility 2. HGB blank voltage is 4.5V
probe and the bath 2. The waste line for the reaction bath needs to be wrapped in the vertical direction to a height above the liquid level with 3mL of liquid in the bath 3. Perform HGB gain calibration Front bath washer (molding WH02-205) Microsensor (D50µm)
801-3005-0005700 045-000809-00
1. Install the aperture
1. Verify the
so that the surface with
reproducibility
the tapered bore faces
2. Verify the
the primary bath
aperture voltage
2. Recalibration RBC shielding bottom
042-007064-00
plate welding piece
Mechanical position
Verify that the
adjustment of RBC
sampling assembly
bath
will not contact with the RBC bath when moving vertically in the RBC bath position
HGB FRU
115-018415-00
Perform HGB gain calibration
Vacuum unit
115-015673-00
Waste pump assembly
115-018416-00
/
HGB blank voltage is 4.5V Verify that the reaction baths can be correctly
(FRU)
drained and vacuum can be
13-3
Commissioning and Verification After Servicing
correctly built 2-way Valve (Mindray)
801-3201-00002-
/
00 2-way Valve (Mindray)
1. Verify the orientation of the inlet/outlet is
801-3201-00004-
correct;
00
2. The hose shall be fully inserted; 3. Thick 50 tubes can not be used again after disconnected from valve ports or connectors 3-way Valve (Mindray)
801-3201-00003-
/
00
1. Verify the NO, NC and Common terminals are connected correctly; 2. The hose shall be fully inserted; 3. Thick 50 tubes can not be used again after disconnected from valve ports or connectors
LVM valve assembly
115-015675-00
Recalibration
1. Verify the NO, NC and Common terminals are connected correctly; 2. The hose shall be fully inserted; 3. Verify the reproducibility
13-4
Commissioning and Verification After Servicing
1ml Pump(eject)
115-014601-00
Recalibration
/
200ul pump
115-014598-00
Recalibration
/
TAKASAGO value assem
115-014726-00
/
1. Verify the pinch valve assembly (T34) is properly positioned in the valve; 2. Cut T75 and case it between T34 and C11
BC-5000 front cover
043-002705-00
BC-5150 front cover
043-002706-00
Touch Panel
801-3110-00184-
Perform touchscreen calibration
Verify normal operations of the touchscreen
00 LCD Module(5000)
115-018417-00
LCD Module(5150)
115-018418-00
Reagent preheating unit
115-015672-00
1. J9 and C10 must be full inserted 2. FRU record
Verify the temperatures are within the ranges
parameters enters new
from the Status
temperature value
screen
from the Temperature Calibration screen Battery Lithium 3V 35mAh D12.5*2.0
801-3100-0022600
Reset date and time
After startup, the
in the Setup screen.
date remains the
Save and reset the
same
analyzer Fan assembly
115-017923-00
/
Verify if the fan rotates
Secure Digital Memory
023-000549-00
Card 8GB
1. Backup the data
/
before replacing the SD card (if possible); 2. Restore the configuration data;
exoteric sampling
043-002703-00 13-5
Adjust the 2 M3 hex
1. Verify there is
Commissioning and Verification After Servicing
keystoke Start key for open-vial mode
801-3100-0019400
screws which fasten
a uniform gap
the aspirate key, in
between the key
order to achieve a
and the front cover
uniform gap between the key and the front
2. Key operation is normal
cover tube package
115-017475-00
/
See the Fluidic System Precautions for Assembly and Service section in the Service Manual
connector package
115-017476-00
/
See the Fluidic System Precautions for Assembly and Service section in the Service Manual
13-6
14 Service BOM Part N.O.
Part Name
051-001159-00
Pinaster board (5 ALL_AM1808)
115-018411-00
Analog Drive Board
051-001319-00
3107 Power board PCBA
051-001062-00
Indicator board PCBA
051-000881-00
6301 touch control board PCBA
115-020624-00
Syringe transfer assembly
115-011902-00
10ml syringe
3101-20-68304
Optical Sensor block of injector
041-005167-00
special bolt 3
115-015338-00
10ml syringe FRU
115-012708-00
250ul syringe(with nozzle)
024-000366-00
Stepping motor
115-015676-00
Sampling Assembly
801-1805-00013-00
Elevator Motor(2S42Q-05640A)
801-3003-00015-00
Rotation Motor Position Sensor Assembly
042-007187-00
probe press plate
801-3001-00055-00
sensor package
801-3102-00057-00
Ф1.5 mop FRU
801-3101-00002-00
Sample Probe(for BC-5300 only)
3005-20-44746
probe wipe clamp
115-018412-00
RBC count pool module(FRU)
042-007065-00
RBC shielding box
115-015987-00
HGB count pool module
Service BOM
043-000711-00
filter
801-3003-00045-00
Isolation chamber clamp
801-3005-00057-00
Preventive Kit
045-000809-00
Ruby Red Cell Counter(D50um)
M6M-010063---
Seal for pressure sampling connector
042-007064-00
RBC shielding bottom plate welding piece
115-018414-00
RBC pool cover
115-018415-00
HGB FRU
115-015673-00
Vacuum unit
115-018416-00
waste water pump assembly
801-1805-00006-00
Vacuum chamber assembly
801-3201-00002-00
2-way Valve (Mindray)
801-3201-00003-00
3-way Valve (Mindray)
801-3201-00004-00
2-way Valve (Mindray)
115-015675-00
LVM valve assembly
115-014601-00
1ml Pump(eject)
115-014598-00
200ul pump
115-014726-00
TAKASAGO value assem
043-002705-00
BC-5000 front cover
043-002706-00
BC-5150 front cover
801-3110-00184-00
Touch Panel, resistive, 10.4″, four wire
115-018417-00
LCD Module(5000)
115-018418-00
LCD Module (5150)
115-015672-00
Reagent preheating unit
115-015678-00
Micro-switch assembly
M07-00131F---
FUSE Time-lag 250V 3.15AD5X20
0030-10-13055
Power filter
14-2
Service BOM
115-015677-00
Diluent temperature testing unit
115-017730-00
liquid detect assembly
801-3100-00226-00
Battery Lithium 3V 35mAh D12.5*2.0
115-017923-00
Fan assembly
509B-10-05996
Chinese power cord
801-3201-00053-00
M-68D CAP Assembly
115-016034-00
DIFF Lyse Cap Assembly
115-013091-00
Waste bottle cap assembly
801-3110-00167-00
Diluent Assembly holder
023-000549-00
Secure Digital Memory Card 8GB
110-002557-00
Installer CD
043-002703-00
exoteric sampling keystoke
801-3100-00194-00
Start key for open-vial mode
115-017475-00
tube package
115-017476-00
connector package
051-001621-00
Liquid detect board PCBA
043-000829-00
Reagent detection tube
14-3
15 Appendices A.
Fluidic diagram
A-1
B.
Connection and Tube
ID
Material type
1 2 3 4 5 6 7
syringe WBC RBC Vacuum Pump probe probe wipe
chamber 8 9 Valve 10 Valve Valve 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Valve Valve Valve Valve Valve Valve Valve Valve Valve Valve Valve Valve Valve valVe
Name in the diagram
Part NO.
Name
SR WBC RBC VC LP SPB SPB Isolation chamber1,I solation chamber2 SV1 SV2
115-015652-00 115-015987-00 115-015986-00 115-015673-00 115-015674-00 3101-20-68488 3102-20-69178
syringe assembly GHB cound pool module RBC cound pool module Vacuum/Pressure Chamber waste water pump subassembly sampling probe probe wipe
115-002439-00
Isolation chamber filter
115-010088-00 115-010088-00
SV3
115-007667-00 115-010089-00 115-010089-00 115-010089-00 115-010089-00 115-010088-00 115-010089-00 115-010089-00 082-000446-00 115-010089-00 115-010089-00 115-010089-00 115-010089-00 115-010089-00 115-014726-00
3-way Valve (Mindray) 3-way Valve (Mindray) mirco solenoid valve of two-way(higher operating pressure) 2-way Valve (Mindray) 2-way Valve (Mindray) 2-way Valve (Mindray) 2-way Valve (Mindray) 3-way Valve (Mindray) 2-way Valve (Mindray) 2-way Valve (Mindray) Valve.3-way -75~250kPa DC12V 2-way Valve (Mindray) 2-way Valve (Mindray) 2-way Valve (Mindray) 2-way Valve (Mindray) 2-way Valve (Mindray) TAKASAGO value assem
115-017730-00
liquid detect assembly
SV4 SV5 SV6 SV7 SV8 SV9 SV10 SV11 SV12 SV13 SV14 SV15 SV16 PV18 Hydraulic Sensor 26 Sensor Preheat Preheat Bath 27 Bath 28 Pump DP1 29 Pump DP2 30 Valve CV1 Temperatur 31 Sensor e Sensor 32 Filter LF 33 / / 34 / / 35 Tube T1 36 Tube T2 37 Tube T3 38 Tube T4 39 Tube T5 40 Tube T6 41 Tube T7 42 Tube T8 43 Tube T9 44 Tube T10 45 Tube T11 46 Tube T12 47 Tube T13
Position in the Fluidic diagram D2 B3 B4 D5 D4 D2 D2
C3,C4
A4 A4 C2 B2 C2 A2 B5 A4 D3 C3 C2 B5 C5 C3 C3 C2 B3 C2
115-015672-00
Preheat Bath
A3
115-014601-00 115-014598-00 BA40-10-62038
1ml Pump(eject) 200ul pump Check Valve A of WU
A4 B4 A3
115-015677-00 0010-10-12408 / / 082-000108-00 082-000108-00 082-000108-00 0040-10-32301 M90-100031--M90-100031--M90-100031--M6G-020007--082-000108-00 082-000108-00 082-000108-00 082-000108-00 M90-100071---
Diluent temperature testing unit B1 Inline Filter 43um 1/8” I.D. Tubing A5 / / / / Tube.M-87-D3,2mmX3.5mm,AV31X2103 C1 Tube.M-87-D3,2mmX3.5mm,AV31X2103 C1 Tube.M-87-D3,2mmX3.5mm,AV31X2103 B1 Tubing. FEP,0.040"X0.066"（1feet） D2 tube.PTFE,1.7mmIDX2.55mmOD C2 tube.PTFE,1.7mmIDX2.55mmOD C2 tube.PTFE,1.7mmIDX2.55mmOD C2 Tube OD3mm ID1mm EVA C2 Tube.M-87-D3,2mmX3.5mm,AV31X2103 C1 Tube.M-87-D3,2mmX3.5mm,AV31X2103 C1 Tube.M-87-D3,2mmX3.5mm,AV31X2103 C1 Tube.M-87-D3,2mmX3.5mm,AV31X2103 C2 Tubing.3/32"X5/32",S-50-HL AAX02004,Tygon(20feet) C2
B-1
Appendices
Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube
T14 T15 T16 T17 T18 T19 T20 T21 T22 T23 T24 T25 T26 T27 T28 T29 T30 T31 T32 T33 T34 T35 T36
M90-100071--M90-100071--M90-100071--082-000108-00 082-000108-00 082-000108-00 M90-000025--082-000108-00 M90-100031--M90-100031--082-000108-00 082-000055-00 082-000055-00 082-000108-00 082-000108-00 082-000108-00 082-000055-00 M90-100031--M90-100031--M6G-020009--M6G-020034--0040-10-32301 3001-10-07069
Position in the Material description Fluidic diagram Tubing.3/32"X5/32",S-50-HL AAX02004,Tygon(20feet) C3 Tube.3/32"X5/32",S-50-HLAAX02004,Tygon C3 Tube.3/32"X5/32",S-50-HLAAX02004,Tygon C4 Tube.M-87-D3,2mmX3.5mm,AV31X2103 A1 B1 Tube.M-87-D3,2mmX3.5mm,AV31X2103 A4 Tube.M-87-D3,2mmX3.5mm,AV31X2103 A5 Tube.1/8"X1/4",R-3603 AAC02007,Tygon A2 Tube.M-87-D3,2mmX3.5mm,AV31X2103 C2 Tube.PTFE,0.066"IDX0.098"OD B2 Tube.PTFE,0.066"IDX0.098"OD B5 Tube.M-87-D3,2mmX3.5mm,AV31X2103 A4 Tube.1/16"X3/16",F-5500-A,Fluran A4 Tube.1/16"X3/16",F-5500-A,Fluran Tube.M-87-D3,2mmX3.5mm,AV31X2103 B3 Tube.M-87-D3,2mmX3.5mm,AV31X2103 B3 Tube.M-87-D3,2mmX3.5mm,AV31X2103 B4 Tube.1/16"X3/16",F-5500-A,Fluran A4 A3 Tube.PTFE,0.066"IDX0.098"OD A3 Tube.PTFE,0.066"IDX0.098"OD B3 Tubing. Silica gel 0.031"ID 0.156"OD B3 3-way valve tubing(1.6*3.2 B3 Tube.PTFE,0.040"IDX0.066"OD C3 Tube.1/16"X1/8",S-50-HLAAX02002,Tygon
71 Tube
T37
M90-100071---
Tube.3/32"X5/32",S-50-HLAAX02004,Tygon
72 Tube
T38
73 Tube
T39
74 Tube 75 Tube
T40
M90-100071---
Tube.3/32"X5/32",S-50-HLAAX02004,Tygon
T41
M90-100071---
Tube.3/32"X5/32",S-50-HLAAX02004,Tygon
C5 C5
T42
M90-100071--3001-10-07069 3001-10-07069 0040-10-32301 M90-100071--082-000055-00 M90-100031--M6G-020056--M6G-020056--3001-10-07069 3001-10-07069 082-000108-00 3001-10-07069 3001-10-07069 M90-000025--M90-100071--M90-100071--M90-100031--M90-100031--M6G-020006--M6G-020006---
Tube.3/32"X5/32",S-50-HLAAX02004,Tygon
C5
Tube.1/16"X1/8",S-50-HLAAX02002,Tygon Tube.1/16"X1/8",S-50-HLAAX02002,Tygon Tube.PTFE,0.040"IDX0.066"OD Tube.3/32"X5/32",S-50-HLAAX02004,Tygon Tube.1/16"X3/16",F-5500-A,Fluran Tube.PTFE,0.066"IDX0.098"OD Tube.EVA,ID:1/16＂,OD：1/8＂，clear Tube.EVA,ID:1/16＂,OD：1/8＂，clear Tube.1/16"X1/8",S-50-HLAAX02002,Tygon Tube.1/16"X1/8",S-50-HLAAX02002,Tygon Tube.M-87-D3,2mmX3.5mm,AV31X2103 Tube.1/16"X1/8",S-50-HLAAX02002,Tygon Tube.1/16"X1/8",S-50-HLAAX02002,Tygon Tube.1/8"X1/4",R-3603 AAC02007,Tygon Tube.3/32"X5/32",S-50-HLAAX02004,Tygon Tube.3/32"X5/32",S-50-HLAAX02004,Tygon Tube.PTFE,0.066"IDX0.098"OD Tube.PTFE,0.066"IDX0.098"OD Tube.Silicone,1/16"X3/16",TYGON 3350 Tube.Silicone,1/16"X3/16",TYGON 3350
C4 D3 B2 C3 A4 A4 A4 A5 B5 B4 C2 B5 C5 C5 C2 C4 B3 B4 B3 B4
Material ID type 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70
76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96
Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube
Name in the diagram
Part NO.
C4 M90-100071---
Tube.3/32"X5/32",S-50-HLAAX02004,Tygon C4
M90-100071---
Tube.3/32"X5/32",S-50-HLAAX02004,Tygon C4
T43 T44 T45 T46 T47 T48 T49 T50 T51 T52 T53 T54 T55 T56 T57 T58 T59 T60 T61 T62
B-2
Appendices
ID
Material type
97 Tube 98 Tube 99 Tube 100 Tube 101 Tube
Name in the diagram T63 T64 T65
0040-10-32301 M90-100031--0040-10-32301
Tube.PTFE,0.040"IDX0.066"OD Tube.PTFE,0.066"IDX0.098"OD Tube.PTFE,0.040"IDX0.066"OD
T66
M90-000025---
Tube.1/8"X1/4",R-3603 AAC02007,Tygon
T67 T68
M90-100071--M90-000025---
Tube.3/32"X5/32",S-50-HLAAX02004,Tygon Tube.1/8"X1/4",R-3603 AAC02007,Tygon
Part NO.
Material description
Position in the Fluidic B3 B2 B2 C5 C5
102 103 104 105 106 107 108 109 110 111 112
Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube Tube
T69 T70 T71 T72 T73 T74 T75 T76 T77 T78
M90-000025--M6G-020034--M6G-020034--M6G-020055--M90-000025--M6G-020055--M90-000025--M90-000025--M6G-020006--0040-10-32301
Tube.1/8"X1/4",R-3603 AAC02007,Tygon 3-way valve tubing(1.6*3.2) 3-way valve tubing(1.6*3.2) Tube.TPU,ID：1/8＂,OD：1/4＂,clear Tube.1/8"X1/4",R-3603 AAC02007,Tygon Tube.TPU,ID：1/8＂,OD：1/4＂,clear Tube.1/8"X1/4",R-3603 AAC02007,Tygon Tube.1/8"X1/4",R-3603 AAC02007,Tygon Tube.Silicone,1/16"X3/16",TYGON 3350 Tube.PTFE,0.040"IDX0.066"OD
D5 D4 C5 B5 B5 D5 D4 B3 A4 B2 B2
113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144
T79 Tube Transit tube J1 Transit tube J2 Transit tube J3 Transit tube J4 Transit tube J5 Transit tube J6 Transit tube J7 Transit tube J8 Transit tube J9 Transit tube J10 Transit tube J11 Transit tube J12 Transit tube J13 Transit tube J14 Transit tube J15 Transit tube J16 Transit tube J17 Transit tube J18 Transit tube J19 Transit tube J20 Transit tube J21 Transit tube J22 Transit tube J23 Transit tube J24 Transit tube J25 Transit tube J26 Transit tube J27 Transit tube J28 Transit tube J29 Transit tube J30 Transit tube J31
M90-100071--M6G-020009--M6G-020009--082-000055-00 082-000055-00 082-000055-00 M6G-020006--082-000055-00 082-000055-00 082-000055-00 M6G-020009--M6G-020009--M6G-020009--0030-20-13339 082-000055-00 0030-20-13339 M90-100071--M6G-020006--M90-100071--M6G-020006--M6G-020009--M6G-020009--082-000055-00 0030-20-13339 M6G-020009--082-000055-00 0030-20-13339 082-000055-00 082-000055-00 082-000055-00 0030-20-13339 0030-20-13339
Tube.3/32"X5/32",S-50-HLAAX02004,Tygon Tubing. Silica gel 0.031"ID 0.156"OD（1feet） Tubing. Silica gel 0.031"ID 0.156"OD（1feet） Tube.1/16"X3/16",F-5500-A,Fluran Tube.1/16"X3/16",F-5500-A,Fluran Tube.1/16"X3/16",F-5500-A,Fluran Tube.Silicone,1/16"X3/16",TYGON 3350 Tube.1/16"X3/16",F-5500-A,Fluran Tube.1/16"X3/16",F-5500-A,Fluran Tube.1/16"X3/16",F-5500-A,Fluran Tubing. Silica gel 0.031"ID 0.156"OD（1feet） Tubing. Silica gel 0.031"ID 0.156"OD（1feet） Tubing. Silica gel 0.031"ID 0.156"OD（1feet） Transit tube(1.5mm-3mm)(Mould MR13339) Tube.1/16"X3/16",F-5500-A,Fluran Transit tube(1.5mm-3mm)(Mould MR13339) Tube.3/32"X5/32",S-50-HLAAX02004,Tygon Tube.Silicone,1/16"X3/16",TYGON 3350 Tube.3/32"X5/32",S-50-HLAAX02004,Tygon Tube.Silicone,1/16"X3/16",TYGON 3350 Tubing. Silica gel 0.031"ID 0.156"OD（1feet） Tubing. Silica gel 0.031"ID 0.156"OD（1feet） Tube.1/16"X3/16",F-5500-A,Fluran Transit tube(1.5mm-3mm)(MouldMR13339) Tubing. Silica gel 0.031"ID 0.156"OD（1feet） Tube.1/16"X3/16",F-5500-A,Fluran Transit tube(1.5mm-3mm)(MouldMR13339) Tube.1/16"X3/16",F-5500-A,Fluran Tube.1/16"X3/16",F-5500-A,Fluran Tube.1/16"X3/16",F-5500-A,Fluran Transit tube(1.5mm-3mm)(MouldMR13339) Transit tube(1.5mm-3mm)(MouldMR13339)
B2 D2 C2 C2 C2 C2 C2 A3 A3 B3 B3 B3 B2 B2 A4 A4 B3 B3 B4 B4 B2 B3 B2 B2 B2 B2 B2 C2 C2 A3 B2 B2
B-3
Appendices
ID
145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177
Material type Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Connection Tube Transit tube Transit tube Transit tube Tube Tube
Name in the diagr am C1 C2 C3 C4 C5 C6 C7 C8 C9 C10 C11 C12 C13 C14 C15 C16 C17 C18 C19 C20 C21 C22 C23 C24 C25 C26 C27 T80 J32 J33 J34 T81 T82
Part NO.
M90-100028--M90-100028--M90-100028--M90-100028--M90-100028--M90-100028--M90-100028--M90-100028--M90-100028--043-000880-00 M90-100028-03 M90-100026--M90-100026--043-000892-00 043-000892-00 M90-100027--M90-100027--082-001140-00 082-001141-00 082-001140-00 082-001141-00 M90-100009--M90-100025--M90-100009--M90-100025--M90-100100--M90-100100--0040-10-32301 0030-20-13339 082-000055-00 082-000055-00 M6G-020056--M6G-020056---
Material description
3/32 PE TEE FITTING-WHITE NYL T420-1 3/32 PE TEE FITTING-WHITE NYL T420-1 3/32 PE TEE FITTING-WHITE NYL T420-1 3/32 PE TEE FITTING-WHITE NYL T420-1 3/32 PE TEE FITTING-WHITE NYL T420-1 3/32 PE TEE FITTING-WHITE NYL T420-1 3/32 PE TEE FITTING-WHITE NYL T420-1 3/32 PE TEE FITTING-WHITE NYL T420-1 3/32 PE TEE FITTING-WHITE NYL T420-1 8.5mm three way connector Connection.Y,400Barb,3/32"ID,White Nylon Nylon plug (located at the reagent inlet) Nylon plug (located at the reagent inlet) straight tube tie-in straight tube tie-in Connection.Straight Through Reduction,1/8"&3/32"ID Connection.Straight Through Reduction,1/8"&3/32"ID Connection.Male Luer 2mm"ID natural PVDF Connection.FemaleLuer,1/4-28UNF,1/8"ID Connection.Male Luer 2mm"ID natural PVDF Connection.FemaleLuer,1/4-28UNF,1/8"ID Connection.FemaleLuer,1/4-28UNF,1/8"ID Connection.Male Luer,1/8"Barb,White Nylon Connection.FemaleLuer,1/4-28UNF,1/8"ID Connection.Male Luer,1/8"Barb,White Nylon Connection.Elbow,400Barb,3/32"ID,White,L420-1 Connection.Elbow,400Barb,3/32"ID,White,L420-1 Tube.PTFE,0.040"IDX0.066"OD Transit tube(1.5mm-3mm)(Mould MR13339) Tube.1/16"X3/16",F-5500-A,Fluran Tube.1/16"X3/16",F-5500-A,Fluran Tube.EVA,ID:1/16＂,OD：1/8＂，clear Tube.EVA,ID:1/16＂,OD：1/8＂，clear
B-4
Position in the fluidic diagram C1 C1 C1 C1 C3 B5 C5 C5 C4 B3 B3 B3 B4 A4 A4 C5 A5 B5 B5 B5 B5 A5 A5 B4 B4 C2 A2 A4 A4 C2 C2 B5 A5
C.
Hardware block diagram
C-1
D.
Cables and Wires
Material ID 009-002857-00
Name Heater connecting wire
009-002858-00
Temperature sensor connecting wire Indicator board connecting wire Analog board supervisory signal wire Optical signal output wire Analog main control board SPI signal wire Optical control signal wire Syringe motor connecting wire Digital power connecting wire Analog power connecting wire Sampling motor connecting wire Electromagnetic metering pump connecting wire Valve connecting wire Waste pump connecting wire Float switch connecting wire Sampling photocoupler connecting wire Touchscreen control cable
009-002863-00 009-002865-00 009-002866-00 009-002867-00 009-002869-00 009-002870-00 009-002871-00 009-002872-00 009-002875-00 009-002877-00 009-002878-00 009-002880-00 009-002881-00 009-002882-00 009-002911-00 009-002913-00 009-002967-00 009-002988-00 009-002989-00 009-003176-00
009-003322-00 009-003381-00 009-003642-00 2800-20-28762 009-004057-00
LCD signal wire RBC connecting wire Safety ground Component ground Syringe assembly photocoupler connecting wire Start key connecting wire Fan adapter cable Hydraulic sensor adapter cable HGB connecting wire LH&DIFF detect board wire
Connection Connects A-J21 with heater and temperature switch Connects A-J10 with temperature sensor Connects B-J78 with indicator board Connects A-J2 and B-J86 Connects A-J4 and B-J85 Connects A-J31 and B-J81 Connects A-J3 and B-J77 Connects A-J32 and syringe motor Connects C-J1/C-J2 and A-J22/B-J68 Connects A-J8 and C-J3 C-J4 Connects A-J24 and sampling motor Connects A-J16 and electromagnetic metering pump Connects A-J14 A-J15 and valves Connects A-J20 and waste pump Connects A-J1 and float switch Connects A-J12 and sampling photocoupler Connects B-J67 and touchscreen drive board Connects B-J4/B-J16 and LCD/backlight Connects A-J6 and RBC bath / / Connects A-J13 and syringe assembly photocoupler Connects B-J99 and start key Connects A-J17 A-J18 and fan Connects A-J11 and hydraulic sensor
Connects A-J5 and HGB bath Connects A-J26 and Liquid detect board PCBA Note: A refers to the analog drive board, B refers to the main control board, C refers to the power board
E. No.
Appendix Table Product Model Inspection Item
Description
1
Electrical connection
Power cable connection
2
Indicator color
Color
3
Indicator sound
Sound
4
Touchscreen
Touchscreen
5
Time and date
Enter time and date
6
Version
7
Syringe and sampling mechanism self-test
8
Valves self-test
9
Fan self-test
10
Mechanical position adjustment
11
Mechanical position adjustment
12
Pressure verification
13
Temperature calibration
14
Temperature calibration
15
Temperature calibration
16 17
Counting channel measurement Counting channel measurement Counting channel measurement
18
19 20 21
Counting channel measurement Counting channel measurement Counting channel measurement
SERIAL NUMBER Requirement Refer to related graphic files in the appendix Red indicates problems, green indicates OK Alarms when problems exist Touchscreen calibration completed Correct time and date entry
Result
Conclusion
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
In latest versions
□OK □NG
□PASS □FAIL
Normal operation
□OK □NG
□PASS □FAIL
Valves
Normal operation
□OK □NG
□PASS □FAIL
Fan
Normal operation
□OK □NG
□PASS □FAIL
Refer to Mechanical position adjustment
□OK □NG
□PASS □FAIL
Refer to Mechanical position adjustment
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
Version and configuration information Syringe and sampling mechanism self-test
Adjustment of the relative position between the sample probe and the WBC bath Adjustment of the relative position between the sample probe and the RBC bath Vacuum Preheat bath temperature calibration Preheat bath temperature calibration Preheat bath temperature calibration Bubbles in sample tube or not Fluid residue on the sample probe Sample probe below the fluid level and clear from the reaction bath Bubbles in sample supply tube or not Bubbles in WBC bath or not Bubbles in RBC bath or not
Pressure within range Machine measurement value
□PASS □FAIL
FRU value
□PASS □FAIL
Overall difference
□PASS □FAIL
No bubbles
□OK □NG
□PASS □FAIL
No residue
□OK □NG
□PASS □FAIL
Normal down position
□OK □NG
□PASS □FAIL
No bubbles
□OK □NG
□PASS □FAIL
Bubbles in bath
□OK □NG
□PASS □FAIL
Bubbles in bath
□OK □NG
□PASS □FAIL
E-1
Connection and Tube
22
Counting channel measurement Counting channel measurement
23 Counting channel measurement 24
25
Counting channel measurement
26
Counting channel measurement
Aperture voltage splash when WBC bubbling or not, bubbles on filling tube or not splash when RBC bubbling or not, bubbles on filling tube or not WBC bath can be drained correctly or not RBC bath can be drained correctly or not
[16, 21]V
□PASS □FAIL
No splash and no contact
□OK □NG
□PASS □FAIL
No splash and no contact
□OK □NG
□PASS □FAIL
Drained correctly
□OK □NG
□PASS □FAIL
Drained correctly
□OK □NG
□PASS □FAIL
WBC bath wall
No residue
□OK □NG
□PASS □FAIL
RBC bath wall
No residue
□OK □NG
□PASS □FAIL
29
Counting channel measurement Counting channel measurement Counting channel measurement
RBC bath shield box installation
Screws tightened
□OK □NG
□PASS □FAIL
30
Counting channel measurement
Sample probe movement
□OK □NG
□PASS □FAIL
31
Counting channel measurement
Sample probe tube
□OK □NG
□PASS □FAIL
32
Maintenance
Perform maintenance and cleaning
Refer to the user's manual
□OK □NG
□PASS □FAIL
RBC aperture voltage
[16, 21]V
□PASS □FAIL
RBC
≤0.02×1012/L
□PASS □FAIL
HGB
≤1g/L
□PASS □FAIL
HCT
≤0.5%
□PASS □FAIL
PLT
≤10×109/L
□PASS □FAIL
27 28
Sample probe moves with no interference Sample probe tube does not interfere with other structures
37
Reaction bath voltage measurement and setup Analyzer status verification - count Analyzer status verification - count Analyzer status verification - count Analyzer status verification - count
38
Optical system tube connection
Connect the optical tubes and fill with fluids
Refer to the service instructions
39
Analyzer voltage
Power (+12V)
[11.5, 12.5]V
□PASS □FAIL
Analyzer voltage
Power (+24V)
[22.0, 29.0]V
□PASS □FAIL
Analyzer voltage
Analog (+12V)
[11.5, 12.5]V
□PASS □FAIL
Analyzer voltage
Constant current source voltage (directly measured)
[47.0, 60.0]V
□PASS □FAIL
Analyzer voltage
LAS blank voltage
[0, 0.5]V
□PASS □FAIL
44
Analyzer current
Laser current
[20, 70]mA
□PASS □FAIL
45
Background Count
WBC
≤0.2×109/L
□PASS □FAIL
46
Background Count
RBC
≤0.02×1012/L
□PASS □FAIL
Background Count
HGB
≤1g/L
□PASS □FAIL
33 34 35 36
40 41 42 43
47
E-2
□OK □NG
□PASS □FAIL
Connection and Tube
48 49 50 51 52 53 54 55 56 57 58
Background Count
HCT
≤0.5%
□PASS □FAIL
Background Count
PLT
≤10×109/L
□PASS □FAIL
Standard particle graphic parameter test Standard particle graphic parameter test Standard particle graphic parameter test Standard particle graphic parameter test Standard particle graphic parameter test Standard particle graphic parameter test Standard particle graphic parameter test Standard particle graphic parameter test Standard particle graphic parameter test Optical gain
Total LAS
1500~3000
LAS CG Position
38~42
LAS CV
≤6.50%
Total MAS
1500~3000
MAS CG Position
107~158
MAS CV
≤3.0%
Total WAS
1500~3000
WAS CG Position
135~220
WAS CV
≤8.0%
59 Optical gain 60 Optical gain 61 Optical gain 62 Impedance gain 63 HGB gain 64 65
Shutdown
LAS MAS WAS Width RBC HGB Shutdown process
N/A: Not applicable N/A: Not applicable N/A: Not applicable N/A: Not applicable N/A: Not applicable N/A: Not applicable No failure or alarm occurs
Tested by:
E-3
□PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □PASS □FAIL □OK □NG Date:
□PASS □FAIL
P/N: 046-008515-00(3.0)
