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)