BC-5150/BC-500 0 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 manual is only provided for qualified service personnel trained by Mindray or Mindray's agents. ● 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. III Table of Contents 1 Overview .................................................................................................................... 1-1 1.1 Overview ..................................................................................................................... 1-1 1.2 Who Should Read This Manual .................................................................................. 1-1 1.3 How to Find Information ............................................................................................ 1-1 1.4 Conventions Used in This Manual .............................................................................. 1-2 1.5 Special Terms Used in This Manual ............................................................................ 1-2 1.6 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 3.1 Overview ..................................................................................................................... 3-1 3.2 Workflow..................................................................................................................... 3-1 3.3 Sample aspiration ........................................................................................................ 3-2 3.4 White Blood Cell Measurement .................................................................................. 3-2 Laser flow cytometry .................................................................................................. 3-2 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 Optical System ........................................................................................................... 6-1 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 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 6.3. Determinating the Optical System Status .................................................................... 6-7 6.4. 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 7 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 Hardware System ...................................................................................................... 8-1 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 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 8.3. 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 8.4. Power Board .............................................................................................................. 8-26 8.4.1 Overview .......................................................................................................... 8-26 8.4.2 Replacement and Connection ........................................................................... 8-27 8.4.3 Troubleshooting................................................................................................ 8-27 8.5. 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 8.6. Touchscreen Drive Board .......................................................................................... 8-33 8.6.1 Overview .......................................................................................................... 8-33 8.6.2 Components...................................................................................................... 8-33 8.6.3 Troubleshooting................................................................................................ 8-33 8.7. Indicator Board ......................................................................................................... 8-34 8.7.1 Overview .......................................................................................................... 8-34 8.7.2 Components...................................................................................................... 8-34 8.7.3 Troubleshooting................................................................................................ 8-35 8.8. Motor, Photocoupler and Microswitch ...................................................................... 8-35 8.8.1 Overview .......................................................................................................... 8-35 8.8.2 Troubleshooting................................................................................................ 8-36 8.9. 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 its maintenance methods 1-2 Chapter 6 Optical System 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 ... 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. WARNING CAUTION read the statement below the symbol. The statement is alerting you to a possibility of analyzer damage or unreliable analysis results. read the statement below the symbol. The statement is alerting NOTE 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. 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 you to an operating hazard that can cause personnel injury. 1-3 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 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. WARNING CAUTION is required to follow the instructions Overvimbol. Failure to do so may place the potential risk of biohazard. The operator follow the instructions below this symbol. so may cause personal injury. or damage of the product or affect the test he operator is required to follow the instructions elow this symbol. Failure to do so may cause 1-4 he operator. he operator is required to follow the instructions below is symbol. The instructions will emphasize important formation or information that requires particular NOTE 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... Overview 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 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. 2 Specifications 2.1. Product Name ∎ Name: Auto Hematology Analyzer ∎ Model: BC-5150/BC-5000 ∎ BC-5150 Appearance ∎ BC-5000 Appearance 2-1 2.1.1 Physical Specifications Height Depth Width Table 2-1 Dimensions and weight BC-5150/BC-5000 Overall Dimensions Width ≤ 325 mm Height ≤ 435 mm (rubber feet included) Depth ≤ 410 mm Weight ≤25Kg 2.1.2 Electrical Specifications Table 2-2 Main unit power supply Parameter Value Voltage (100V-240V~) ±10% Input Power ≤300VA Frequency 50/60±1Hz 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 Requirements Storage Environment Requirements Running Environment Requirements 10°C~30°C -10°C~40°C 10°C~35°C Ambient Temperature Relative Humidity 20%~85% 10%~90% 10%~90% Atmospheric 70kPa~106kPa 50kPa~106kPa 70kPa~106kPa 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 CBC CBC + DIFF Specifications 2-3 Specifications 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# / √ number Abnormal Lymphocytes percentage 2-4 ALY% / √ Large Immature Cells number White blood cell parameters (15 items), including 4 research parameters LIC# Large Immature Cells LIC% / / √ √ percentage Red blood cell parameters (8 items) Red Blood Cell count RBC √ √ Hemoglobin Concentration HGB √ √ Mean Corpuscular Volume MCV √ √ Mean Corpuscular Hemoglobin MCH √ √ Mean Corpuscular Hemoglobin Concentration MCHC √ √ Red Blood Cell Distribution Width - Coefficient of Variation RDW-CV √ √ Red Blood Cell Distribution Width - Standard Deviation RDW-SD √ √ Hematocrit HCT √ √ parameters (6 items) Platelet 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 √ √ √ √ √ √ √ √ √ √ √ √ Histogram English Name Abbreviation CBC CBC + DIFF White Blood Cell Histogram WBC Histogram √ √ Red Blood Cell Histogram RBC Histogram √ √ ● “√”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 Table Table Table 2-4 Background/blank count requirements Background/blank count requirements Background/blank count requirements Background/blank count requirements Parameter Background/blank count requirements WBC RBC HGB HCT PLT ≤ 0.20× 109 /L ≤ 0.02× 1012 /L ≤1g/L ≤ 0.5 % ≤ 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 Platelet Histogram PLT Histogram √ √ Scattergram Name Abbreviation CBC CBC + DIFF Differential Scattergram Diff Scattergram / √ 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 Table Table Table 2-5 Carryover Carryover Carryover Carryover Requirements Requirements Requirements Requirements Parameter Carryover WBC ≤0.5% RBC ≤0.5% HGB ≤0.6% HCT ≤0.5% PLT ≤1.0% Table Table Table Table 2-6 6 6 6 Sample Sample Sample Sample Concentration Concentration Concentration Concentration Range Range Range Range of of of of Carryover Carryover Carryover Carryover Test Test Test Test Parameter Unit High concentration range Low concentration range WBC ×109/L > 15.00 < 3.00 RBC ×1012/L > 6.00 < 2.00 HGB g/L > 200 < 40 HCT ×109/L > 54% <18% PLT ×109/L > 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; x i ---- actual test result of the sample; d ---- absolute deviation of the sample test results. Specifications 2-6 Specifications Table 2-7 Whole Blood Repeatability Requirements Parameter Condition Whole Blood Repeatability (CV/absolute deviation d) 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 Table Table Table 2-8 Linearity Linearity Linearity Linearity Requirements Requirements Requirements Requirements 2-7 Predilute Repeatability (CV/absolute deviation d) WBC 4.00×109 /L~15.00× 109 / L ≤2.0% ≤4.0% 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 RBC /LL ~ 6.00 × 1012 / ≤1.5% ≤3.0% HGB 110 g/L ~ 180 g/L ≤1.5% ≤3.0% MCV 70 fL~120 fL ≤1.0% ≤2.0% 100 × 109 PLT / L ~ 149 × 109 / L ≤6.0% 150 × 109 / L ~ 500 × 109 / L ≤4.0% ≤10.0% ≤8.0% MPV / ≤4.0% ≤8.0% Parameter Linearity Range Deviation Range (Whole Blood) Deviation Range (Predilute) WBC 0.00 × 109/L~ 100.00 ×109/L (for both BC-5000 and BC-5150) ±0.30×109/L or ±5% ±0.60×10 9/L or ±6% 100.01 × 109/L ~ 500.00×109/L (for BC-5150 only) ±10% ±12% Specifications RBC 0.00×1012/L~8.00× ±0.05×1012/L or ±5% ±0.10×10 12/L or ±10% 1012/L HGB 0 g/L~250g/L ±2g/L or ±2% ±4g/L or ±4% PLT 0 × 109/L ~ 1000 × 109/L (for both BC-5000 and BC-5150) 2-8 ±10×109/L or ±8% ±20×10 9/L or ±16% 1001×109/L ~ 5000× 109/L (for BC-5150 only) ±12% ±20% 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 Table Table Table 2-9 Display Display Display Display Range Range Range 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. 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 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 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. 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. Specifications ● 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 Sample Mode Diluent (ml) 2-14 DIFF Lyse (ml) LH Lyse (ml) Probe cleanser (ml) CD 27.5 1 0.2 0 CD 27.5 1 0.2 0 CD 27.6 1 0.2 0 Whole Blood Mode CBC 23.2 0 0.2 0 Capillary Blood Mode CBC 23.2 0 0.2 0 Prediluted Mode 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 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 2-15 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 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 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. 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 Operation Principles 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. =× Sample Photocurre nt 3-3 HGB(g/L) Constant Ln Blank Photocurre nt 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. 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 Operation Principles 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. 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 HCT = RBC × MCV 10 MCH = HGB RBC MCHC = HGB HCT × 100 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. Type Flag Flag Meaning Judgment criterion Interference of PLT clump or NRBC to WBC count and differential may exist: WBC 3-6 1. The DIFF and BASO WBC Abnormal channels are unproportionate. Immature cells or blasts may Immature Cell? exist Many scatter-points in the immature cell area of the scattergram Abn./Atypical Lym? Abnormal Many atypical exist. lymphocytes lymphocytes may or abnormal/ lymphocytes scatter-points area in the atypical 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 Low neutrophils analysis Neutropenia results NEUT# < 1.00×10^9/L Neutrophilia High neutrophils results analysis NEUT# > 11.00×10^9/L Lymphopenia Low lymphocytes results analysis LYMPH# < 0.80×10^9/L Lymphocytosis High lymphocytes results analysis LYMPH# > 4.00×10^9/L Monocytosis High monocytes results analysis MONO# > 1.50×10^9/L Eosinophilia High eosinophils results analysis EO# > 0.70×10^9/L Basophilia High basophils analysis results BASO# > 0.20×10^9/L Pancytopenia WBC, RBC and PLT low Wbc < 4.0×10^9/L and Rbc < 3.5×12^9/L and Plt < 100 ×10^9/L Possible presence of RBC RBC Histogram Abn. microcytes, macrocytes, The distribution of RBC histogram is abnormal Operation Principles anisocytosis, RBC agglutination and dimorphic histogram HGB abnormal or RBC HGB Abn./Interfere? agglutination, or interference may exist (e.g., WBC high) 3-7 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 PLT Possible presence of microcytes, red blood cell debris, giant PLT or PLT clump The distribution of PLT scattergram is abnormal 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 PLT Scattergram Abn. WBC Abnormal R/?Flag parameter: WBC, related DIFF parameters Immature Cell? R/?Flag parameter: Neu%#, Mon%#, Bas%#. Abn./Atypical Lym? R/?Flag parameter: Lym%#, Mon%#, Bas%#, etc. Differ slightly based on the situation. Leucopenia / Leucocytosis / Neutropenia / Neutrophilia / Lymphopenia / Lymphocytosis / Monocytosis / Eosinophilia / Basophilia / Pancytopenia / 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 / Operation Principles Anemia / Erythrocytosis / PLT 3-8 PLT Scattergram Abn. R/?Flag parameter: PLT, MPV, PDW, PCT, PLCR, PLCC, etc. / 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). 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 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. 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. Software and Interface 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. 4.3. Review 4.3.1 Stability Trend Graph Software and Interface 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: 4.3.2 Trend Graph Software and Interface 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. 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: Software and Interface ∎ 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 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]. . 4.4.2 Calibration ∎ Please use specified calibrators for calibration before their expiration date. Software and Interface ∎ 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 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. 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. 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. Software and Interface ∎ Only calibration with calibrators is supported in the Gain Calibration screen. 4-10 ∎ 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: 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, Software and Interface 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. then the background test is passed. 4.9.2 Reproducibility Software and Interface ∎ Normal controls are usually used for reproducibility application at the client end. 4-13 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: T - level-high sample result -T level-low sample result 100 % (%) = First level-low sample result hird result Carryover T hird level-low sample hird × Advanced Toolbox 4.9.4 Reference range of normal samples Parameter Mean Deviation Range NEU_LAS_P 139.91 6.01 NEU_MAS_P 123.87 9.84 NEU_WAS_P 39.40 4.80 NEU_EQWIDTH_P 14.57 0.30 NEU_LAS_CV(%) 6.83 3.15 NEU_MAS_CV(%) 12.95 2.35 NEU_WAS_CV(%) 20.88 2.35 NEU_EQWIDTH_CV(%) 1.12 0.65 4.9.3 Carryover Software and Interface 4-14 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. Software and Interface ∎ 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 ∎ 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 Software and Interface ∎ 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 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. Software and Interface ∎ 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 fluidics action is not allowed 4-18 Yellow light on Initialization and standby status of sequence is not involved in the startup process Enter/Exit standby status Yellow light flashing Enter/Exit standby 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 Prompts Comments 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 If these screens have already Software and 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 Long intermittent bee 4-19 Tap the touchscreen to stop the buzzer Analyzer is ready One short beep Analyzer enters ready status from other status When the screen is black prompting “Please power off the analyzer” Silence If an error occurs during the shutdown process, the buzzer black 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 5-1 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. ∎ 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. 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. 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 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. Data Transmission 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 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. 6-1 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: 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 Optical System Figure 6-4 Physical structure of the optical system 6-3 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. 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. (a) Physical view of the flow cell assembly (b) Operation principle of the flow cell 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. 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 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 6-11 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. 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. Optical System Figure 6-12 Preparation of the 7μm std. part. solution 2. 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. 3. 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 CG Position CV LAS 1500~3000 38~45 ≤6.50 MAS 100~158 ≤3.00 WAS 100~200 ≤8.00 4. 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. 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. Optical System 6-8 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. 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. 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. 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. Optical System 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. 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. 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. 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. Optical System 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 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: Fluidics