BC-5300Vet Auto Hematology Analyzer
© 2009-2010 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issued Date is 2010-12.
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
, , are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.
Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
all installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national
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.
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure. Malfunction or damage caused by unstable or out-of-range power input. Malfunction or damage caused by force majeure such as fire and earthquake. Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough. Others not caused by instrument or part itself.
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. E-mail Address: [email protected]
Tel: +86 755 26582479 26582888 Fax: +86 755 26582934 26582500
EC-Representative: Shanghai International Holding Corp. GmbH(Europe) Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: 0049-40-2513175 Fax: 0049-40-255726
Table of Contents
1 Using This Manual... 1-1
1.1 Introduction... 1-1 1.2 Who Should Read This Manual... 1-2 1.3 How to Find Information ... 1-3 1.4 Conventions Used in This Manual... 1-4 1.5 Symbols... 1-5 2 System Structure... 2-1 2.1 Introduction... 2-1 2.2 Fluidic System ... 2-2 2.3 Hardware System ... 2-2 2.4 Main Unit... 2-2 2.5 Software structure ... 2-9 2.5.1 Menu structure ... 2-9 2.5.2 Passwords... 2-18
3 Instrument Installation and Software Upgrade... 3-1
3.1 Preparations ... 3-1 3.1.1 Purpose ... 3-1 3.1.2 Tools ... 3-1 3.1.3 Accessories ... 3-1 3.2 Installation Requirements ... 3-2 3.2.1 Space Requirements ... 3-2 3.2.2 Power Requirements... 3-2 3.2.3 Environment Requirements... 3-2 3.2.4 PC Configuration Requirements ... 3-3 3.3 Package Checking and Unpacking ... 3-7 3.3.1 Checks before unpacking... 3-7 3.3.2 Unpacking Main Unit ... 3-7 3.3.3 Checking packing list... 3-9 3.4 Removal and Installation ... 3-10 3.5 Connections... 3-17 3.6 Start-up ... 3-21 3.6.1 Inspection before Startup ... 3-21 3.7 Setup and Adjustment ... 3-30 3.8 Testing Other Functions... 3-35 3.9 Confirming Gain... 3-36 3.10 Calibration and Performance Test ... 3-41 3.11 Software upgrade ... 3-50
4.1.3 Pumps ... 4-1 4.1.4 Syringes ... 4-1 4.1.5 Valves... 4-1 4.1.6 Baths ... 4-2 4.1.7 Volumetric tube... 4-2 4.1.8 Filters... 4-2 4.2 Fluidic System ... 4-3 4.2.1 Reagent volume required... 4-3 4.2.2 Fluidic System Drawing... 4-5 4.2.3 WBC Measurement Procedures ... 4-6 4.2.4 RBC/PLT Measurement Procedures... 4-7 4.2.5 HGB Measurement Procedures ... 4-7 4.3 Sequence of Whole Blood CBC+DIFF Measurement... 4-8 4.3.1 Sampling and dispensing procedures... 4-8 4.3.2 DIFF Channel ... 4-10 4.3.3 WBC/HGB Channel... 4-12 4.3.4 RBC/PLT Channel ... 4-15 4.3.5 Sequence of Predilute Mode CBC+DIFF Measurement... 4-17 4.3.6 Sequence of CBC Measurement ... 4-17
5 Hardware System ... 5-1
5.1 Mother board ... 5-3 5.1.1 Introduction... 5-3 5.1.2 Board Composition... 5-3 5.1.3 Adjustment and Test Points... 5-26 5.1.4 Removal ... 5-27 5.1.5 Troubleshooting... 5-29 5.2 Data board ... 5-31 5.2.1 Introduction... 5-31 5.2.2 Board composition... 5-31 5.2.3 Adjustment and Test Points... 5-43 5.2.4 Disassembly and assembly method... 5-47 5.2.5 Troubleshooting... 5-48 5.3 Drive board ... 5-56 5.3.1 Introduction... 5-56 5.3.2 Board composition... 5-56 5.3.3 Adjustment and Test Points... 5-71 5.3.4 Disassembly and assembly method... 5-74 5.3.5 Troubleshooting... 5-76 5.4 Power board ... 5-95 5.4.1 Introduction... 5-95 5.4.2 Board Composition... 5-96 5.4.3 Adjustment and Test Points... 5-101
5.7.1 Introduction... 5-126 5.7.2 Board Composition... 5-126 5.7.3 Adjustment and Test Points... 5-129 5.7.4 Assembly and disassembly... 5-130 5.7.5 Troubleshooting... 5-130 5.8 Pre-amplification board... 5-133 5.8.1 Introduction... 5-133 5.8.2 Board Composition... 5-133 5.8.3 Adjustment and Test Points... 5-137 5.8.4 Disassembly and assembly... 5-137 5.8.5 Troubleshooting... 5-138 5.9 Indicator Board ... 5-140 5.9.1 Introduction... 5-140 5.9.2 Board Composition... 5-140 5.9.3 Disassembly and assembly method... 5-141 5.9.4 Troubleshooting... 5-142
6 Maintenance... 6-1
6.1 Maintenance Module and the Corresponding Settings ... 6-1 6.2 General... 6-3 6.3 Disassembling the Panels ... 6-3 6.3.1 Removing the left door ... 6-3 6.3.2 Removing the right door... 6-4 6.3.3 Removing the top cover ... 6-5 6.3.4 Removing the back panel... 6-6 6.3.5 Removing the front cover assembly... 6-7 6.4 Replacing the Valves, Pumps and Syringes... 6-9 6.4.1 Replacing the valve... 6-11 6.4.2 Replacing the Pressure Chamber ... 6-14 6.4.3 Replacing the Vacuum Chamber ... 6-15 6.4.4 Replacing the Syringe Assembly... 6-17 6.4.5 Replacing the Waste Pump... 6-22 6.5 Replacing the Bath/Aperture Assembly... 6-24 6.6 Replacing the Sampling Module and Adjusting Position ... 6-27 6.6.1 Replacing the Sample Probe and Wipe ... 6-27 6.6.2 Replacing the Optical Sensor... 6-29 6.6.3 Removing the Sampling Module ... 6-31 6.6.4 Adjusting sample probe position ... 6-34 6.7 Maintaining and Replacing the DIFF Reaction Bath ... 6-35
7 Optical System... 7-1
7.1 Optical System Adjustment and Troubleshooting... 7-1 7.2 Removing and Installing Optical System Assemblies... 7-2 7.2.1 Laser driver board ... 7-2 7.2.2 Front light assembly ... 7-3 7.2.3 Flow cell assembly ... 7-4 7.2.4 Rear light collimator assembly ... 7-6 7.2.5 Beam splitter assembly ... 7-6 7.2.6 Rear light collector assembly ... 7-7 7.2.7 Rear light detector assembly... 7-9
7.3.4 Gain setup ... 7-23 7.4 Troubleshooting ... 7-25 7.4.1 Laser spot-deviation... 7-25 7.4.2 Flow cell clog... 7-25 7.4.3 Dirty flow cell ... 7-26
8 Troubleshooting ... 8-1
8.1 Error code and information... 8-1 8.2 Errors indicated by error messages ... 8-7 8.2.1 Pressure errors... 8-7 8.2.2 Reagent errors ... 8-7 8.2.3 Hardware errors ... 8-8 8.2.4 Measurement errors... 8-8 8.2.5 Temperature errors... 8-10 9 Appendixes ... A-1 A. Accessories ...A-1 B. List of Wearing Parts ...B-1 C. Fluidic diagram ... C-1 D. Pump and Valve Function Table ... D-1 E. Tubing...E-1 F. Error Module and the Classified Errors ...F-1 G. Maintenance Module and the Corresponding Settings ... G-1 H. Method to identify cross network cable and direct-connected network cable ... H-1
1
Using This Manual
1.1 Introduction
The chapter explains how to use the hematology analyzer service manual. This manual provides the reference information and procedures. Before servicing hematology analyzer, read and understand the manual carefully for servicing the equipment properly and for your safety.
This manual is to be used in conjunction with the operator’s manual of hematology analyzer. It does not contain information and procedures already covered in the operator’s manual.
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 service manual effectively, the reader should posses: A thorough understanding of
Basic electronic and fluidics principles and devices Reagent systems
Quality control
Troubleshooting concepts The ability to
Use basic mechanical tools and understand related terminology Use a digital voltmeter (DVM) and an oscilloscope
Read fluidics schematics and understand related terminology Read electronic schematics and understand related terminology
1.3 How to Find Information
This service manual comprises 8 chapters and 5 appendices. Refer to the table below to find the information you need.
If you want to … See …
learn about the system structure and the basic principle of the hematology analyzer
Chapter 2 System Structure
learn about the installation requirements and how to upgrade the hematology analyzer software
Chapter 3 System Installation and Software Upgrade
learn about the fluidic system Chapter 4 Fluidic System
learn about the hardware system Chapter 5 Hardware System
learn about how to maintain Chapter 6 Maintenance
learn about the optical system Chapter 7 Optical System
learn about how to troubleshoot the common errors Chapter 8 Troubleshooting
learn about the main spare parts Appendix A List of Spare Parts
learn about the main wearing parts Appendix B List of Wearing Parts
learn about the schematic diagram of the fluidic system
Appendix C Fluidic Diagram
learn about the function of each valve and pump Appendix D Pump and Valve Function Table
learn about the tubing connection Appendix E Tubing
learn about the error module and the classified errors Appendix F Error Module and the
Classified Errors
learn about the maintenance module and the corresponding settings
Appendix G Maintenance Module and the Corresponding Settings
1.4 Conventions Used in This Manual
This manual uses certain typographical conventions to clarify meaning in the text:
all capital letters enclosed in [ ] indicate a key name (either on the pop-up keyboard or the external keyboard), such as [ENTER].
bold letters included in “ ” indicate text you can find on the screen, such as “Clean”. bold letters indicate chapter titles, such as Chapter 1 Using This Manual.
All illustrations in this manual are provided as examples only. They may not necessarily reflect your analyzer setup or data displayed.
1.5 Symbols
You will find the following symbols in this manual:
When you see… Then…
Read the statement below the symbol. The statement is alerting you to an operating hazard that can cause personnel injury.
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 you to information that requires your attention.
Read the statement below the symbol. The statement is alerting you to a potentially biohazardous condition.
You may find the following symbols on the analyzer, reagents, controls or calibrators.
When you see… It means…
CAUTION, CONSULT ACCOMPANYING DOCUMENTS.
BIOLOGICAL RISK
HIGH VOLTAGE
WARNING, LASER BEAM
EARTH (GROUND)
ALTERNATING CURRENT
BATCH CODE
USE BY
SERIAL NUMBER
CATALOG NUMBER (FOR CONTROLS)
DATE OF MANUFACTURE
MANUFACTURER
TEMPERATURE LIMITATION
CONSULT INSTRUCTIONS FOR USE
BRINGING POTENTIAL NEGATIVE CONSEQUENCES TO THE
ENVIRONMENT AND HUMAN HEALTH. FOR MORE DETAILED INFORMATION WITH REGARD TO RETURNING AND RECYCLING THIS PRODUCT, PLEASE CONSULT THE DISTRIBUTOR FROM WHOM YOU PURCHASED THE PRODUCT.
Be sure to observe the following precautions for the safety of patients, operators and yours when you are servicing the analyzer.
It is important for the laboratory 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.
Contacting exposed electronic components while the equipment is attached to power can cause personal injury from electric shock or damage to electronic components. Power down before removing covers to access electronic components.
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.
Possible mechanical movement of the warned position may lead to personal injury during the normal operation, removal and maintenance.
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
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.
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.
This equipment must be operated by skilled/trained professionals.
Samples, controls, calibrators and waste are potentially infectious. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
All the analyzer components and surfaces are potentially infectious.
Take proper protective measures for operation or maintenance.
The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.
2
System Structure
2.1 Introduction
Hardware
Hardware collects signals, controls and drives moving parts, and processes and displays information. It mainly consists of the mother board, drive board, data board, power board, laser control board, FS pre-amplification board, SS pre-amplification board, volumetric board, indicator board and liquid-level detecting board.
Interface
The system mainly consists of two parts, the main unit (analyzer) and the external computer, which are connected through the network port. Other connections are realized through the interfaces of the external computer.
Software operating environment
The system software consists of the main unit software and the operation software. The main unit software is operated on the data board inner the analyzer; the operation software is operated under the WINDOWS platform of the external computer. The main unit software analyzes the sequence, collects and identifies data. The operation software displays and prints the results and stores them into the database, and realizes the interaction of the functions including count, QC, calibration, maintenance, data management and communication, etc.
Fluidic System
The fluidic system indicates the tubing where reagents, samples and air pass in the analyzer. The fluidic system controls the correlatively jointed fluidic parts in a set sequence by the software and driving of the hardware to control the distribution and direction of the medium.
2.2 Fluidic System
Refer to Chapter 4 Fluidic System of this manual
2.3 Hardware System
Refer to Chapter 5 Hardware System of this manual
Figure2-2 Back of the main unit
1 --- V-53D Diluent sensor connector 2 --- V-53D Diluent inlet 3 --- V-53 cleanser inlet 4 --- V-53LH Lyse inlet 5 --- V-53LEO(Ⅱ)Lyse inlet 6 --- V-53LEO(Ⅰ)Lyse Inlet 7 --- Waste outlet 8 --- Waste sensor connector 9 --- AC input 10 --- Network interface
Figure2-3 Left side of the main unit
1--- Door Lock 2---Sample Probe
Figure2-4 Right side of the main unit
Figure2-5 Front of the main unit (front cover removed)
1 --- Sampling Module 2 --- Aspirate Key
3 --- Sampling syringe assembly 4 --- Sample injection syringe assembly 5 --- Sheath fluid syringe assembly 6 --- Relieve valve assembly
Figure2-6 Left side of the main unit (left door removed)
1 --- Front door assembly 2 --- Diluent syringe assembly 3 --- Lyse syringe assembly 4 --- Pressure chamber assembly
5 --- Air pumps 6 --- Left door
7 --- liquid level detection unit 8 --- Valve assembly (2) 9 --- Valve assembly (1) 10 --- Power switch 11 --- Drive board 12 --- Data board 13 --- Mother board 14 --- Top cover
Figure2-7 Right side of the main unit (right door removed)
1 --- Optical system 2 --- Fluidic valves 3 --- Isolation chamber 4 --- Sampling assembly 5 --- Volumetric unit 6 --- Fluidic valves 7 --- Vacuum chamber assembly 8 --- Right door
9 --- Waste pump assembly 10 --- Valve assembly (3)
2.5 Software structure
The software system consists of the main unit software which operates on the data board inner the analyzer and the operation software which operates under the WINDOWS platform of the external computer. The main unit software analyzes sequence, collects data and calculates the parameters. The operation software realizes the interaction of the functions including count, QC, calibration, maintenance, data management and parameter setup, etc.
2.5.1 Menu structure
1. Shortcut button area
When switching to any screen, a guidance bar will always be displayed on the left of the screen containing 8 frequently used shortcut buttons. Click them to perform the corresponding operations. The menu structure of the shortcut buttons is shown in Figure2-8.
Figure2-8 Menu structure of the shortcut button area
2. Review screen
The Review menu has four submenus: Count, Table, Data Export and Compare. The “Table” review includes the function of auto-backup, which will be performed automatically by the software when the condition of backup is fulfilled. The menu structures of each screen of the “Review” screen are shown below.
Figure2-9 Menu structure of the Count screen
Table
3. QC screen
The menu structure of the QC program is shown in Figure2-11. QC
Run Settings
Graph
Have Preset Values
Table Set Limits Start QC Run Pos./Total New Vial Data Compare Display Order Calculate Preset Values
Save Preset Values Outliers Delete Pos./Total Delete Pos./Total Save Print Print Print Communication Data Backup Data Export History Print
Figure2-11 Menu structure of the QC program
4. Service
“Maintenance” screen
The menu structure of the “Maintenance” screen is shown in Figure2-12. Maintenance Clean Replace Reagent Maintain LEO(I) Lyse Maintain the whole device LEO(II) Lyse Diluent WBC Bath RBC Bath Unclog Zap Apertures Flush Apertures Probe Cleanser Soak
Cleanser Soak Soak DIFF Bath Soak WBC Bath
Empty DIFF Bath Fluidics Initialization LH Lyse Cleanser All Reagents DIFF Bath Flow Cell Sample Probe Soak RBC Bath Empty WBC Bath Empty RBC Bath
Figure2-13 Menu structure of the “Status” screen
“Self-test” screen
Self-test Others Motor Valve Sample Injection Syringe Motor Lyse Syringe Motor
Diluent Syringe Motor
Sheath Fluid Syringe Motor Sampling Syringe Motor Sample Probe Horizontal Motor Print Valve 1-15 Valve 21-39 Print WBC Volumetric Tube Filter RBC Volumetric Tube Filter WBC Aperture Voltage RBC Aperture Voltage Print Sample Probe Vertical Motor All Valves Count Time
Debug Sample ProbeDIFF Bath Backward Forward Start Up Down Ok
Figure2-15 Menu structure of the “Debug” screen
“Counter” screen
The menu structure of the “Counter” screen is shown in Figure2-16.
Figure2-16 Menu structure of the “Counter” screen
“Log” screen
5. “Setup” screen
The “Setup” screen contains screens of “Gain”, “Data Format”, “Reagent”, “Auxiliary”, “Para. Unit”, “Ref. Range”, “Print”, “Auto Maintenance”, “User and Password”, “Lab Info”, “Advanced”, “Algorithmic parameter”, “Species Name” and “Diff Algorithm”. The menu structure of the “Setup” screen is shown in Figure2-19.
Auxiliary Reagent Date Format Para. Unit Ref. Range Print Setup Communication Advanced Maintain
User and Password
Delete Edit New Reset password Change password Close Auto-maintain Gain Lab Info. Algorithmic Parameter Species Name Diff Algorithm
Figure2-19 Menu structure of the “Setup” screen
6. “Calibration” screen
7. Shutdown
The menu structure of “SHUTDOWN” is shown in Figure2-21.
SHUTDOWN Sleep
Shutdown
Figure2-21 Menu structure of “SHUTDOWN”
8. Exit
The menu structure of “EXIT” is shown in Figure2-22.
EXIT Logout
Exit
Figure2-22 Menu structure of “EXIT”
2.5.2 Passwords
The passwords are divided into three levels: common user, administrator and service engineer. An administrator is enabled all authorities of a common user, and a service engineer is enabled all authorities of an administrator. Tables below introduce the authorities enabled for each password level.
Table2-1 Authorities enabled for common user level
Count Data/Count, Saving of DIFF, Print, Data Browse (the buttons of “Validate”, “Edit Result” and “Restore Result” are available, but when you click them, a message box will pop up for authority identification.) Saving of the “Microscopic Exam.” screen, Print and Data Browsing.
TABLE Save, Print, Communication, Deselect, Search, Trend Graph, CV, arrow buttons above the “Pos./Total” control (the buttons of “Validate”, “Batch Validate”, “Edit Result” and “Restore Result” are available, but when you click them, a message box will pop up for authority identification.)
Data Export Data Export Review
Auto-backup Auto-backup
QC L-J QC setup: switch the file No. to browse file information of different lot No.(but can not edit the QC settings)
L-J QC count: QC Run, Data browse and Print
L-J QC graph: New Vial, Data Compare, Display Order, Calculate Preset Values, Save Preset Values, Outliers, Print and Data browse function of the “Pos./Total” control.
L-J QC table: Print, Communication, Data Backup, Data Export, History and Browse
Maintenance Replace Reagent, Clean, Maintain the whole device, Maintain
Status Temperature&Pressure, Voltage&Current, Sensor&Photocoupler, check the status
information of the “Signal Collection” screen, export and print Current Screen Status and All Status
Self-test Self-test for motors, valves and other items and print the test results
Counter Check the statistics data of the counter, print the data
Log Check, print and modify logs including “Set Paras”, “Other Logs” and “All Logs”
Date Format Date Format
Reagent Exp. Date and Lot No.
Auxiliary
Enable or disable the prompt box in the Predilute Mode
Method of Entry for Sample ID Prefix of the Sample ID
All the contents of the “Other” items of the “Auxiliary” screen
User and Password
Check the information of the “User list” screen, but New, Edit, Delete and Reset password are disabled.
When log in as common user level, the password of the current login user can be modified.
Setup
Lab Information
Lab Information can be browsed but can not be edited.
Shortcut Code
Shortcut Code
Shortcut code can be browsed but operation including New, Edit and Delete are disabled.
Calibration Calibration Factors
Browse and print the User Calibration Factors
Help Help Check the help information SHUTDOWN
SHUTDOWN Perform the Sleep and Shutdown procedures
EXIT EXIT Log out and exit the system
Table2-2 Authorities enabled for administrator level
Level Module Screen Authorities enabled
Run Sample All screens except the “QC Administrator
TABLE Validate, Batch Validate, Edit Result and Delete
Data Export
Auto-backup
QC L-J QC setup: Set the QC files which have not obtained the QC run results; set and save the Ref. range and Limits L-J QC count: all functions
L-J QC graph: Delete L-J QC table: Delete Maintenance
Status Print sets
Self-test Counter
Log Check, print and modify the “Error Info.” log Service
Version and Config.
Information
General Setup
“Authority” setting items of the “Auxiliary” screen
Para. Unit, Ref. Range, Print,, Communication, Gain, Automaintain, check and set the parameters of each screen
User and Password
New, Edit, delete user, reset the passwords of all users and change the own password Lab
Information Check and edit the Lab Information Species Name Rename Species Name
Setup
Diff Algorithm Setting Diff Algorithm of custom species Shortcut Code Shortcut Code New, Edit and Delete the shortcut code
Calibration Factors
Browse, print, save and restore the User Calibration Factors
Calibration
Calibrator
Calibration in the OV-WB mode
Calibrate one or more parameters among WBC, RBC, HGB, MCV and PLT.
Table 2-3 Authorities enabled for service engineer level
Level Module Screen Authorities enabled
Run Sample All screens except the “QC Run” and “Service” (Maintenance, Status, Self-test and Debug)
Graph Special Info.
TABLE Optical Data Export
Review
Auto-backup QC
Maintenance Replace All Reagents
Empty WBC Bath, Empty RBC Bath and Empty DIFF Bath at the “Maintenance” screen
Status Export the Analyzer Information Self-test
Counter Initialize the statistics of all items except the number times of samples being run; check the detail information of number of times of effective samples being run, QC and calibration.
Log Export Log; check, print and modify the log of “RunSequence” Debug Debug Service Version and Config. Service Engineer
Lab Information Shortcut Code
Advanced Maintain Species Name Rename Species
Diff Algorithm Setting Diff Algorithm of custom species
Calibration Factors
Browse and print the User Calibration Factors; browse, print, save and restore the Factory Calibration Factors; Initialize User Calibration Factors and Factory Calibration Factors
Calibration
Calibrator
1. Factory calibrator calibration in the WB-CBC, WB-CBC+DIFF, PD-CBC and PD-CBC+DIFF mode.
2. Calibrate one or more parameters among WBC, RBC, HGB, MCV, PLT and MPV.
Help Help SHUTDOWN SHUTDOWN
3
Instrument Installation and Software
Upgrade
3.1 Preparations
3.1.1 Purpose
Install the instrument properly as per the procedures introduced in this chapter.
3.1.2 Tools
Blade or clipper
Clamp used for locating the volumetric tube USB flash drive
Pipette (200μl)
Cross-headed screwdriver
The software copied in the U-drive must be the specified one for the analyzer of the specified model. Otherwise, you can not proceed to install.
3.1.3 Accessories
Plastic test tube Pipette
7μm standard particle Gloves
Tissues
3.2 Installation Requirements
3.2.1 Space Requirements
Check the site for proper space allocation. In addition to the space required for the main unit itself, arrange for:
at least100 cm on both left and right sides; at least 50 cm behind ;
enough room on or below the countertop to accommodate the Reagent Kit.
3.2.2 Power Requirements
1. Make sure the main unit is properly grounded. Before turning on the main unit, make sure the input voltage meets the requirements.
2. Using pinboard may bring the electrical interference and the analysis results may be unreliable. Please place the main unit near the electrical outlet to avoid using the plug-board.
3. Please use the original electrical wire shipped with the main unit. Other electrical wire may damage the analyzer or cause unreliable analysis results.
Voltage: A.C. 100V-240V Input power: ≤300 VA Frequency: 50/60 Hz
3.2.3 Environment Requirements
The installation environment of main unit must meet the following requirements: 1. Optimal operating temperature: 15 ℃- 30 ℃
2. Optimal operating humidity: 30 % - 85 % 3. Atmospheric pressure: 70 kPa - 106 kPa
4. The environment should be as free as possible from dust, mechanical vibrations, loud noises, pollution and electrical interference.
5. It is advisable to evaluate the electromagnetic environment prior to the operation of this main unit. Make sure the electromagnetic interference is less than CLASS B. Do not use
Make sure the installation environment meets the above 8 requirements. Otherwise, the performance of the main unit might be affected.
3.2.4 PC Configuration Requirements
1. Startup the computer, then right-click “My Computer” and select “Properties” to enter the property screen shown in Figure 3-2. You can check the operation system and RAM of the computer here. They should meet the following requirements:
Operation system：Windows XP Home/XP Professional + SP2 / SP3, Windows Vista Home/Ultimate 32bit , Windows 7 Home/Ultimate 32bit .
RAM：1024MB at least
Figure 3-2 System properties
2. Right-click the desktop and select “Properties”, and then click the “Settings” tag to enter the screen shown in Figure 3-4. You can check the resolution of the display here. It should meet the following requirements:
Resolution：1024 x 768 or higher (adjust as shown in Figure )；
Operating system
Figure 3-4 Setting screen resolution
3. Double-click “My Computer” to enter the screen shown in Figure 3-5. You can check the space available on each disk here. It should meet the following requirements:
Hard disk space：4GB available on one disk at least.
Figure 3-5 My computer
Disk space Screen resolution
The PC hardware configuration and operation system must meet the
3.3 Package Checking and Unpacking
3.3.1 Checks before unpacking
Please check if the package is intact before unpacking.
3.3.2 Unpacking Main Unit
1. The appearance of the main unit is shown in Figure 3-6. Cut off the binding belt before unpacking.
Figure 3-6 External package of main unit
2. Cut off the binding belt and remove the wooden cover. Then, remove the accessory box shown in the figure below.
Figure3-7 Remove wooden cover
3. Lift the carton to expose the main unit.
Figure3-8 Remove accessory box
Figure3-9 Remove carton
5. Remove the plastic bag from the main unit. Grab the bottom of the main unit and lift it onto a countertop. Note that the main unit must be lifted by at least two persons.
Figure 3-10 Lift main unit
When lifting the main unit, keep it as level as possible.
3.3.3 Checking packing list
3.4 Removal and Installation
1. Open the right door of the main unit, remove the plastic cable tie vertically fixing the sampling assembly and remove the clamp fixing the synchronous belt, as Figure 3-11 shows.
Figure 3-11 Remove the plastic cable tie and the clamp
2. Copy the installation files from the disk to the U drive. Then, plug the U drive to the USB interface and then open the installation folder.
3. Double-click “Setup.exe” to install the software.
4. A progress bar shown in Figure 3-12 will pop up. Please wait while the software is installing the components needed.
5. An installation directory box will pop up with the default directory: D:\Mindray\Auto Hematology Analyzer. You can click “Browse” to change the directory if necessary. Then, click “Next” to continue installing as shown in Figure 3-13.
Figure 3-13 Selecting directory
6. A progress bar shown in Figure 3-14 will pop up. Please wait while the software is being installed.
Figure 3-14 Progress bar
7. When the copying operation of the software is finished, a process bar shown in Figure 3-15 will pop up. Please wait while the software is performing post-installation tasks.
Figure 3-16 Installation finished.
If it is found that the main unit software mismatches the PC software, you
should upgrade the main unit software as per the procedures specified in 3.11.2 to match it with the software of the PC-end.
9. Install the driver program of the printer properly on the PC.
10. The hematology analyzer consists of the IPU PC and the main unit as designed. Only basic interactive keys are located on the main unit like the [Aspirate] key. The rest of the operations are realized through the IPU PC. The IPU PC has two network interfaces, one connecting the main unit and the other one may connect to other information devices (e.g. LIS system) or the LAN of the hospital, which are used to export data. There are two icons of “Local Area Connection” for the two network interfaces existed. follow the procedures to configure the network interfaces of the IPU PC:
Figure 3-18 Connection properties
(3) At the “Local Area Connection Properties” screen, select “Internet Protocol (TCP/IP)” and then click “Properties”. At the pop-up screen, select “Use the following IP address”, and then enter 10.0.0.1 into the “IP address” box and 255.255.255.0 into the “Subnet mask” box, as shown in Figure 3-19 .
(4) Then, click “OK” to save all the settings.
Never set the “Default gateway” and DNS server for the network interface
(10.0.0.1) connecting the main unit. Otherwise, you may not access to the network connecting the other network interface.
If other computers or network are connected to the IPU PC (through the
other network interface), be sure that the IP address 10.0.0.1 (used by the IPU PC) or 10.0.0.2 (used by the main unit) is not applied to other computers or computers in the other network.
11. The LIS computer is used to transmit data by connecting the IPU computer. Do as follows to check and set the IP for the LIS computer.
(1) At the desktop of the LIS computer, right click “My Network Places” and select “Properties” from the pop-up dialog box, as shown in Figure 3-20 .
Figure 3-20 “Network Neighbor” (LIS computer)
(2) Right click the “Local Area Connection” icon and select “Properties”, as shown in Figure 3-21 .
Then, the following box will pop up:
Figure 3-22 Connection properties (LIS computer)
(3) At the “Local Area Connection Properties” screen, double click “Internet Protocol
Figure 3-23 Setting IP address
(4) Check and record the IP address shown in the screen. It will be used to set the IP information on the main unit.
(5) If the IP address is not displayed here, you should set it manually (do not set the gateway and DNS server). After setting the IP address, the subnet mask will be generated automatically. Then, click “OK” to save the settings.
3.5 Connections
1. See Figure 3-24 for connections of reagent and waste containers. Note that the V-53LEO(I) lyse, V-53LEO(II) lyse, V-53LH lyse and the analyzer should be placed in a plane of the same level, and the V-53D diluent, V-53 cleanser, and waste containers should be placed under the countertop.
Figure 3-24 Connections of reagent and waste containers
Make sure the tubes are electrically isolated.
See Figure 3-25 for proper connections of reagent and waste containers. Note that the tube connectors and their counterparts on the analyzer are of the same colors.
power outlet.
Figure 3-26 Connection of PC and power supply
3. Connect the Main Unit with the IPU computer by a cross network cable, as shown in Figure 3-27 .
(1) Connect the hematology analyzer with the LIS computer by a cross network cable, as shown in Figure 3-28 .
Figure 3-28 Connecting the main unit and the LIS computer
Be sure to use the cross network cable to connect the analyzer and the LIS computer.
The two ends of a cross network cable can be randomly plugged into the two computers respectively.
(2) Connect the IPU computer to the LAN of the hospital, as shown in Figure 3-29 .
Figure 3-29 Connecting the IPU computer and LAN
Be sure to use the direct-connected network cable to connect the IPU computer to the LAN.
Adopt one of the two ways to finish the network connection according to the condition of the hospital or doctor’s requirement.
5. Connect the printer with the IPU computer with specified cable and connect the power cord properly.
3.6 Start-up
3.6.1 Inspection before Startup
Check and make sure the marks on the relieve valve are on the same line, as shown in Figure 3-30. Change the relieve valve if the marks are not on the same line.
Figure 3-30 Marks on relieve valve
1. Check and make sure the sampling tube and the two pipes connected the probe wipe are not bended and clogged at the place of the flatten cable clamp (at top of the sampling assembly), as shown in Figure 3-31.
Figure 3-31 Sampling and probe wipe tubing
2. Before starting up, remove the right door of the analyzer, and then check and make sure the tubes connecting the V25, V26 and the tee-connector of the volumetric tube are not bended and clogged, as Figure 3-32 shows.
Marks on relieve valve
Check and make sure the sampling tube and the two pipes connected the probe wipe are not bended and clogged here.
Figure 3-32 Tubing free from bending and clogging
3. Check and make sure the thick 50 tube connecting the V27 is not bended and clogged, as Figure 3-33 shows.
Figure 3-33 Tubing free from bending and clogging
4. Check and make sure the two-way connector and the tee connector connecting tube 1 are in the same distance towards the pinch valve, as shown in Figure 3-34 .
Check and make sure the tubes connecting the V25, V26 and the tee-connector of the volumetric tube are not bended and clogged
Check and make sure the thick 50 tube connecting the V27 is not bended and clogged
Figure 3-34 Checking the pinch valve
3.6.2 Start up for the first time
1. Turn on the main unit, wait a moment and then a prompt will appear on the task bar. It means the local-connection-related network interface connects the main
unit already. Similarly, if the other prompt appears on the task bar, it means the local-connection-2-related network interface doesn’t connect the main unit, and it is available to connect the LAN of the hospital. If the two prompts are all
then, you should unplug the network cable connecting the main unit from the IPU computer, and then plug it into the other network interface; then, plug the network cable connecting the LIS computer into the rest network interface. 2. Double click the “Auto Hematology Analyzer” icon on the desktop of the IPU computer to
start up the software. Then, enter the user name “service” and the password “Se s700” (note: there is a space between “e” and ”s”) into the login box, as shown in Figure 3-35 , and then click “OK” to initialize the analyzer.
Tube 1
Tee connector Two-way
Figure 3-35 Logging in
3. During the initialization, a dialog box “Skip fluidic initialization?” will pop up. Click “No” to continue the initialization.
Figure 3-36 “Skip fluidic initialization?”
4. When initialization is finished, click “Menu” “Setup” “Communication” to enter the screen shown below. Set the IP address and Port here, and then click “OK” to save the settings.
Figure 3-37 Communication setup
The IP address you set here should be the one of the LIS computer connecting the IPU computer. The Port you set here should be the interception port of the LIS computer. The IP address of external server cannot be 10.0.0.1 and 10.0.0.2, and format like 10.0.0.* is not recommended.
5. Before transmitting data, make sure the LIS computer connecting the IPU computer is working. Thus, the IPU program could locate the destination for transmitting.
6. If the connection is established between the IPU computer and the LIS computer, the “LIS” icon in the IPU screen will turn to colorful, as shown in Figure 3-38, indicating you can start transmitting data now.
The data communication will be terminated automatically once the IPU software is closed. The LIS computer is the server terminal and the IPU software is the customer terminal. The IPU software keeps trying to connect after starting up, if it is intercepted correctly by the server terminal, then the connection will be established and ready for communication.
The IPU computer can connect LIS computer through cross network cable; connect LIS computer in the same network through devices like HUBs or exchangers; connect LIS computer in a different network through devices like routers.
3.6.3 Inspection after Startup
1. Click “Menu”→“Service”→“Version and Config. Information”, as shown in Figure 3-39 to enter the version and configuration information screen shown in Figure 3-40.
Figure 3-40 Version and config. Info.
2. Boot Software, Application Software, Operating System, Driver Board FPGA, Driver Board MCU, Data board FPGA, Fluidics Sequence and Algorithm Library, as shown in Figure 3-40, and then close the message box.
3. Do the background count once again. Check if there is fluid hanging on the exterior wall or the tip of the sample probe. If the fluid were found, find out the cause and remove the error. Then, do the background count again until there is no fluid.
Figure 3-41 Observing the sample probe
4. Use the cross-headed screw driver to remove the screws fixing the shielding cover of the bath, and then remove the shielding cover as shown in Figure 3-42. Then, do the background count once. Check and make sure there is no spill when WBC and RBC bath dispensing fluid but the bath bubbles normally during the count, as shown in Figure 3-43.
Figure 3-42 Removing bath shielding cover
M3X8 assembled scrwes
Two dispensing
tubes of WBC bath Dispensing tubes of
RBC bath
Bubbling area of
WBC bath Bubbling area of
Figure 3-44 Observing liquid level of volumetric tubes
Liquid level of WBC
3.7 Setup and Adjustment
3.7.1 Setting Parameters
1. At the main screen, click “Menu”→“Setup”→“Reagent” to enter the reagent screen where you can set the expiration date for the reagents, as shown in Figure 3-45.
Figure 3-45 Clicking “Reagent”
2. Set the expiration date for the following reagents: “Diluent”, “LEO (I) Lyse”, “LEO (II)
Figure 3-46 Setting the expiration date
3. At the main screen, click “Menu”→“Setup”→“Advanced” to enter the screen shown in Figure 3-48.
Figure 3-48 “Advance” screen
4. Confirm whether the WBC and RBC count mean time that you recorded previously complies with the time displayed in the screen, as shown in Figure 3-48. Enter the recorded mean time if the time displayed doesn’t comply with the recorded one. Then, use the cross-headed screw driver to re-assemble the screws, fixing the shielding cover of the volumetric board and the bath.
3.7.2 Adjusting Position
1. Press the [Aspirate] key. Then, the analyzer will run a background count once.
2. At the Count screen, click the “Special info.” button as shown in Figure 3-49 to enter the special information screen shown in Figure 3-50.
Figure 3-49 Clicking “Special info.”
Figure 3-50 “Special info.” screen
3. Firstly, make sure the DIFF pulse data length is less than 200. Otherwise, do the background count till the DIFF pulse data length is less than 200, as shown in Figure 3-50. Use the cross-headed screw driver to remove the shielding cover of the volumetric board, as shown in Figure 3-51. Make sure the WBC Start signal delay is within [2.5, 3] and the RBC Start signal delay is within [4, 4.5]. If they are found out of the limit, use the positioning fixture to measure the distance between the tee connector under the volumetric tube and the lower fixing plate of the volumetric board, and according to the
tube downwards; When RBC start signal delay is more than 4.5s, fine adjust the RBC volumetric tube upwards. When the WBC and RBC Start signal delay are within the limit, do the background count three times consecutively to check and make sure the two values are within the range every time, and then record the values of the last time. Meanwhile, check the WBC and RBC count time and calculate the mean time. Then, close the special info. message box.
Be sure to adjust the position of the volumetric tube by your hand directly. Never pull the tee connector hard to adjust, otherwise, the tee connector may leak.
Figure 3-51 Removing the shielding cover of the volumetric board
3.8 Testing Other Functions
Click “Menu”→“Setup”→“Print” to enter the print screen. You can set the connection between the IPU computer and the printer here, as shown in Figure 3-53.
3.9 Confirming Gain
3.9.1 HGB blank voltage
After the transportation and initialization, the HGB blank voltage required may differ from the factory settings.
Thus, confirming and adjusting the HGB blank voltage through gain setup is necessary. 1. Entering the setup screen
At the main screen, click “Menu→ Setup→Gain” to enter the screen.
Thus, adjusting the gain of the optical system is necessary. Do as follows to adjust:
1. At the “Count” screen, select Next Sample as “Dog - WB - CBC+DIFF” and then perform the background count once and make sure the background results meet the specified requirement.
2. At the “Count” screen, select the work mode as “Dog - WB - CBC+DIFF”. Then, prepare the standard particle sample at the ratio that dispenses 3 drops of standard particles into 1ml distilled water. Then, well mix the sample and run the sample once.
Be sure to use the distilled water to prepare the standard particle sample. Prepared standard particle sample should be run within 12 hours.
3. When finish running, enter the “Table” screen and select the standard particle sample just run, and then click the “Optical” button.
Figure 3-55 “Table” review screen
Figure 3-56 Optical screen
5. If the peak position and 0.1max width of the standard particles do not meet the requirements, calibrate the optical gain as per Section 3.9.3 Gain of Optical System.
3.9.3 Gain of Optical System
1、At the “Count” screen, select the work mode as “Dog - WB - CBC+DIFF”. Then, prepare the standard particle sample at the ratio that dispenses 3 drops of standard particles into 1ml distilled water. Then, well mix the sample and run the sample once.
Be sure to use the distilled water to prepare the standard particle sample. Prepared standard particle sample should be run within 12 hours.
Figure 3-57 “Table” review screen
3、At the “Optical” screen, click the “Calculate” button. Then enter the target of the standard particle into the peak target of FS and SS of particle 1, FS taget:18.1;SS target:104.2. The analyzer will automatically calculate and record the proper gain for FS and SS. Click the “Gain Setup” button to apply all species FS and SS values. Click “Close” to exit the optical screen.
Figure 3-58 Optical screen
3.10 Calibration and Performance Test
3.10.1
Background Count
Back to the “Count” screen and perform the background count in “Dog – WB - CBC+DIFF” mode. The background results shall meet the specified requirement: WBC:≤0.1×109/L, RBC:≤0.03×1012/L, HGB:≤1g/L, HCT:≤0.5%, PLT:≤5×109/L.
3.10.2
Carryover
Follow the procedure 3 instructed in section 9.3.1 of the Operator’s Manual to make sure the carryover of the analyzer meets the requirements listed in the table below:
Parameter Carryover WBC ≤0.5％ RBC ≤0.5％ HGB ≤0.6％ HCT ≤0.5％ PLT ≤1.0％
3.10.3
Reproducibility
In the “Dog – WB - CBC+DIFF” mode, make sure the reproducibility of the analyzer meets the requirements specified in Appendix B 5.4 of the Operator’s Manual
The CV requirements for whole blood mode:
Para. Condition CV% / absolute deviation d (WB)
WBC (6.00-15.00)×109/L ≤3.0％
RBC (3.50-10.00)×1012/L ≤2.0%
HGB (110-180) g/L ≤2.0%
MCV (60-95) fL ≤1.0%
PLT (150-500)×109/L ≤6.0%
The CV requirements for predilute mode:
Para. Condition CV% / absolute deviation d (PD)
WBC (6.00-15.00)×109/L ≤4.0％
3.10.4
Calibration
1. Click “Menu→Calibration”, and then click “Calibrator” to enter the screen. Select the calibration mode as “Whole Blood”; enter the lot No. and the expiration date of the calibrator, and then enter the WBC, RBC, HGB, MCV, PLT and WBCO targets of the calibrator into the table. Enter the WBC target value in the WBCO target field (the WBC and WBCO target values are the same).
Figure 3-60 Calibration (WB)
Figure 3-61 Calibration (WB)
3. Well mix the calibrator and then open the cap and present the calibrator under the sample probe, making sure the sample probe is plunged into the calibrator, and then press the aspirate key. When you hear the beep, remove the calibrator. The analyzer will start running automatically. Run the calibrator consecutively for 12 times.
Figure 3-62 Calibration (WB)
When “Calibrator calibration done!” pops up, Click “OK”.
Figure 3-63 Calibration (WB)
Click “Yes” to save the new calibration factors while closing the message box and switching to another screen.
Click “No” to close the message box without saving and switch to another screen. Click “Cancel” close the message box.
4. Click “Diluent” and then present the tube under the sample probe, and then press the aspirate key to start dispensing the diluent, as Figure 3-64 shows. Dispense the diluent into the tube for 6 times consecutively.
Figure 3-64 Dispensing diluent
Figure 3-65 Mix the sample
7. Back to the “Calibrator” screen, and then select the calibration mode as “Predilute” and enter the lot No. and the expiration date of the calibrator, and then enter the WBC, RBC, HGB, MCV, PLT and WBCO targets of the calibrator into the table. Enter the WBC target value in the WBCO target field (the WBC and WBCO target values are the same).
8. Click the “Start” button.
Figure 3-67 Calibration (PD)
9. Present the calibrator well mixed as instructed by procedure 6 under the sample probe, making sure the sample probe is plunged into the calibrator, and then press the aspirate key, as Figure 3-68 shows. When you hear the beep, remove the calibrator. The analyzer will start running automatically. Run the calibrator consecutively for 12 times.
Be sure to immerse the tip of the sample probe into the calibrator.
Figure 3-69 Calibration (PD)
When “Calibrator calibration done!” pops up, Click “OK”.
Figure 3-70 Calibration (PD)
Click “Yes” to save the new calibration factors while closing the message box and switching to another screen.
Click “No” to close the message box without saving and switch to another screen. Click “Cancel” close the message box.
3.11 Software upgrade
3.11.1
Upgrading the PC installed software
1. Release the Installation package on the disk and copy them to the U drive. Plug the U drive to the USB interface and open the folder containing the installation package. Double click the “setup.exe” to start the installation, a progress bar will pop up as shown in Figure 3-71 Please wait when software is installing components needed.
Figure 3-71 Installing components needed
2. At the pop-up box shown in Figure 3-72, select “Upgrade” and click “Next” to upgrade the program. (If you need to install the software as a new one, select “Install” and click “Next”).
3. Then, a progress bar shown in Figure 3-73 will appear. Pleas wait when software is copying files.
Figure 3-73 Copying files
4. After the copying operation is finished, a progress bar will pop up when software is performing post-installation operations.
Figure 3-74 Upgrade complete
5. When the upgrade is finished, a dialog box shown in Figure 3-75 will pop up. Click “OK” to complete the upgrade of the PC installed software.
Figure 3-75 Upgrade complete
3.11.2
Upgrading the software of the main unit (analyzer)
1. Click “Start”→“All Programs”→“Auto Hematology Analyzer software”→“Analyzer
Upgrade”, as shown in Figure 3-76, and then a message shown in Figure 3-77 will pop up.
Click “Analyzer Upgrade” and a login message box will pop up. Enter the user name: “service”, and password: “Se s700”, and then click “OK”, as shown in Figure 3-78.
Figure 3-78 Login box
2. If the software version is lower than 1.5(EDH002), “Upgrade Preparing” operation is needed. Please wait until the operation is finished. Then follow the pop-up message to restart the analyzer.
Figure 3-79 Upgrade Preparing finished.
3. An upgrade directory message box will then pop up. Click “Browse”, and then select the “update” folder of the main unit upgrade files, and then click “OK”, as shown in Figure 3-80. Then, click “OK” in the pop-up message box, as shown in Figure 3-81. Then, the message box as shown in Figure 3-82 will pop up, click “OK” to enter the screen shown in Figure 3-83, where you can select the upgrade items, and then click “OK”.
Figure 3-80 Selecting upgrade files
Figure 3-83 Upgrade items screen
4. Then, the selected items will be upgraded automatically, as shown in Figure 3-84. Please wait for moment. When finish upgrading, a message box will pop up to ask you to restart the main unit as shown in Figure 3-85, click “OK” to close it.
Figure 3-85 Upgrade complete
5. Then, restart the main unit to complete the upgrade.
Never try to delete the files under ftp://10.0.0.2/3101 before upgrading.
4
Fluidic System
4.1 Introduction of Fluidic Parts
4.1.1 Sample probe
Aspirates and dispenses the blood sample
4.1.2 Probe Wipe
Washes the interior and exterior of the sample probe
4.1.3 Pumps
P1: provides pressure for the pressure chamber to generate bubbles. P2: empties the DIFF bath and vacuum chamber and creates vacuum. P3: empties the probe wipe, WBC bath and RBC bath.
4.1.4 Syringes
Aspiration-Syringe: full volume 100 μl; it aspirates and dispenses samples and aspirates the second diluted sample.
Diluent-Syringe: full volume 12ml; it dispenses diluent into the WBC and RBC bath and supplies the diluent to the probe wipe.
Lyse-Syringe: full volume 2.5ml; 3 syringes are driven by a motor; it dispenses M-53Leo (I), M-53Leo (II) and M-53H.
Sheath-Syringe: full volume 12ml; it dispenses the sheath into the flow cell, cleans the flow cell and DIFF bath, and is also be used for sample preparation.
Sample-Syringe: full volume 250μl; it dispenses the sample into the flow cell.
4.1.5 Valves
Fluidic valve: turns on and off by electromagnetic force; controls the fluidic or air flow direction.
4.1.6 Baths
WBC bath: consists of a front bath, back bath and aperture. The WBC sample mixes and reacts here and it is used for the measurement of HGB and WBC.
RBC bath: consists of a front bath, back bath and aperture. The RBC sample mixes and reacts here and it is used for the measurement of RBC/PLT.
DIFF bath: DIFF sample mixes and reacts here.
Vacuum chamber: creates and stores stable vacuum for counting the WBC and RBC by impedance method; cleans the back bath and empties the volumetric tube.
Pressure chamber: creates and stores stable pressure to generate bubbles for the baths. WBC isolation chamber: provides air buffer to isolate outside interference
RBC isolation chamber: provides air buffer to isolate outside interference
4.1.7 Volumetric tube
WBC volumetric tube: volume 500ul; it measures the volume of the WBC sample RBC volumetric tube: volume 300ul; it measures the volume of the RBC sample
4.1.8 Filters
Filter of WBC volumetric tube: it filters the air entered the WBC volumetric tube Filter of RBC volumetric tube: it filters the air entered the RBC volumetric tube P1 filter: it filters the air entered the air pump.
4.2 Fluidic System
4.2.1 Reagent volume required
Sample analysis for a single sample each time
2 analysis modes: Open vial-whole blood mode and open vial-predilute mode.
Table 4-1 Reagent volume required when running samples
Volume of single analysis Reagents Name CBC+DIFF CBC Diluent V -53D Diluent 45mL 30mL V -53LEO(I) Lyse 1.8ml 0 V -53LEO(II) Lyse 0.15ml 0 Lyse V -53LH Lyse 0.5ml
Normal startup function (excluding background) Reagents volume required:
Table 4-2 Reagents volume required when starting up normally
Reagents Name Volume of normal startup
Diluent V -53D Diluent 89ml V -53LEO(I) Lyse 0 V -53LEO(II) Lyse 0 Lyse V -53LH Lyse 2ml Cleanser V -53 Cleanser 0
Abnormal startup function (excluding background) Reagents volume required:
Table 4-3 reagents volume required when starting up abnormally
Reagents Name Volume of abnormal startup Diluent V -53D Diluent 172ml V -53LEO(I) Lyse 0 V -53LEO(II) Lyse 0 Lyse V -53LH Lyse 2ml Cleanser V -53 Cleanser 0
Reagents volume required:
Table 4-4 reagents volume required for starting up a drained system (after the Prepare to Ship procedure has been done)
Reagents Name
Volume of starting up a drained system (after the prepare to ship procedure has been done)
Diluent V -53D Diluent 207ml V -53LEO(I) Lyse 12ml V -53LEO(II) Lyse 12ml Lyse V -53LH Lyse 12ml Cleanser V -53 Cleanser 8ml
Normal shutdown function Reagents volume required:
Table 4-5 reagents volume required when normally shutting down
Reagents Name Volume of normal shutdown
Diluent V -53D Diluent 53ml V -53LEO(I) Lyse 0 V -53LEO(II) Lyse 0 Lyse V -53LH Lyse 0 Cleanser V -53 Cleanser 29ml
4.2.2 Fluidic System Drawing
Figure 4-1 Fluidic system (Whole Blood Mode)
