BC-20s/BC-30s AUTO HEMATOLOGY ANALYZER
SERVICE MANUAL
© 2012－2015 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issued Date is 2015-03.
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 changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor 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 and local requirements. the product is used in accordance with the instructions for use.
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.
Ⅰ
NOTE This equipment must be operated by skilled/trained clinical professionals.
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.
Customer Service Department Manufacturer:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:
Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057,P.R.China
Website:
www.mindray.com
E-mail Address:
[email protected]
Tel:
+86 755 81888998
Fax:
+86 755 26582680 EC-Representative:
Shanghai International Holding Corp. GmbH(Europe)
Address:
Eiffestraβe 80, Hamburg 20537, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
II
Table of Contents 1 Using This Manual ................................................................................................................... 1-1 1.1 Overview ..................................................................................................................... 1-1 1.2 Who Should Read This Manual .................................................................................. 1-1 1.3 Using This Manual ...................................................................................................... 1-1 1.4 Conventions Used in This Manual .............................................................................. 1-2 1.5 Safety Information ...................................................................................................... 1-2 1.6 When you see... ........................................................................................................... 1-4 2 Product Specifications ............................................................................................................. 2-1 2.1 Product Name .............................................................................................................. 2-1 2.2 Physical Specifications................................................................................................ 2-2 2.3 Electrical Specifications .............................................................................................. 2-2 2.4 Environment Requirements ......................................................................................... 2-3 2.5 Product Specifications ................................................................................................. 2-3 2.5.1 Sample mode ................................................................................................. 2-3 2.5.2 Throughput .................................................................................................... 2-3 2.6 Testing Parameters ...................................................................................................... 2-3 2.7 Performance Requirements ......................................................................................... 2-4 2.7.1 Background/Blank Count .............................................................................. 2-4 2.7.2 Carryover....................................................................................................... 2-4 2.7.3 Repeatability ................................................................................................. 2-5 2.7.4 Linearity ........................................................................................................ 2-6 2.8 Display Range ............................................................................................................. 2-7 2.9 Product Description..................................................................................................... 2-7 2.9.1 Main unit ....................................................................................................... 2-9 2.9.2 Power/status indicator ................................................................................... 2-9 2.9.3 Power input connector................................................................................... 2-9 2.9.4 [Aspiration] Key.......................................................................................... 2-10 2.9.5 USB ports .................................................................................................... 2-10 2.10 Product Configuration ............................................................................................... 2-10 2.11 Reagents, Controls and Calibrators ........................................................................... 2-10 2.11.1 Reagents ...................................................................................................... 2-10 2.11.2 Reagent Consumption Volume .....................................................................2-11 2.11.3 Controls and Calibrators...............................................................................2-11 2.1. Information Storage Capacity ....................................................................................2-11 3 System Principles ..................................................................................................................... 3-1 3.1 Introduction ................................................................................................................. 3-1 3.2 Analyzer Workflow ..................................................................................................... 3-1 3.3 Aspiration .................................................................................................................... 3-2 3.4 Dilution ....................................................................................................................... 3-2 1
Table of Contents 3.5
3.6
3.7 3.8
WBC Measurement ..................................................................................................... 3-2 3.5.1 Measurement Principle:................................................................................. 3-2 3.5.2 WBC-Related Parameters ............................................................................. 3-3 3.5.3 HGB Measurement........................................................................................ 3-5 RBC/PLT Measurement .............................................................................................. 3-5 3.6.1 Impedance Method ........................................................................................ 3-5 3.6.2 RBC-Related Parameters............................................................................... 3-6 3.6.3 PLT-Related Parameters ................................................................................ 3-7 Wash ............................................................................................................................ 3-8 Troubleshooting .......................................................................................................... 3-8 3.8.1 Flags .............................................................................................................. 3-8 3.8.2 Shielding Protocol ....................................................................................... 3-10
4 Software and Interface ............................................................................................................ 4-1 4.1. Login ........................................................................................................................... 4-1 4.1.1 User ID and Password for Service Level Access .......................................... 4-1 4.1.2 System Self-test When Logging in at Service Access Level ......................... 4-1 4.2 Review ........................................................................................................................ 4-3 4.2.1 Trend Graph .................................................................................................. 4-3 4.3 Calibration ................................................................................................................... 4-4 4.3.1 Calibration Factors ........................................................................................ 4-4 4.3.2 Calibration with Calibrator............................................................................ 4-5 4.4 Sample Probe Debug ................................................................................................... 4-6 4.5 Temperature Calibration.............................................................................................. 4-6 4.6 Gain Calibration .......................................................................................................... 4-7 4.7 Gain Setup ................................................................................................................... 4-8 4.8 Performance .............................................................................................................. 4-10 4.8.1 Background Count ...................................................................................... 4-10 4.8.2 Reproducibility .............................................................................................4-11 4.8.3 Carryover..................................................................................................... 4-12 4.9 Advanced Toolbox .................................................................................................... 4-12 4.9.1 Language Setup ........................................................................................... 4-13 4.9.2 One-key Export ........................................................................................... 4-13 4.10 Software Update ........................................................................................................ 4-14 4.11 Status Indicator.......................................................................................................... 4-16 4.12 Buzzer ....................................................................................................................... 4-16 5 Data Transmission .................................................................................................................... 5-1 5.1 LIS Connection ........................................................................................................... 5-1 5.1.1 Network communication ............................................................................... 5-1 5.1.2 Serial Interface Communication.................................................................... 5-3 5.1.3 Transmission Mode ....................................................................................... 5-4 5.2 Setup of Data Management Software.......................................................................... 5-5 5.2.1 Communication Parameter Setup .................................................................. 5-5
2
Table of Contents
5.3
5.2.2 Communication Instrument Management ..................................................... 5-6 Troubleshooting for Communication Errors ............................................................... 5-6
6 Fluidics ..................................................................................................................................... 6-1 6.1 Introduction to Fluidic Parts........................................................................................ 6-1 6.1.1 Mindray valves .............................................................................................. 6-1 6.1.2 LVM fluidic valve ......................................................................................... 6-2 6.1.3 Linkage Syringe Device ................................................................................ 6-2 6.1.4 Preheating bath .............................................................................................. 6-3 6.1.5 Vacuum pump................................................................................................ 6-3 6.1.6 Air pump ....................................................................................................... 6-4 6.1.7 Sample probe ................................................................................................. 6-5 6.1.8 Probe wipes ................................................................................................... 6-5 6.1.9 Baths.............................................................................................................. 6-6 6.1.10 Filters..................................................................................................... 6-6 6.2 Sample Dilution Flow Chart ....................................................................................... 6-7 6.2.1 Whole Blood Mode ....................................................................................... 6-7 6.2.2 Predilute Mode .............................................................................................. 6-8 6.3 Introduction to Fluidic Channels ................................................................................. 6-9 6.3.1 WBC/HGB channel ....................................................................................... 6-9 6.3.2 RBC/PLT channel........................................................................................ 6-10 6.4 Sample Volume ......................................................................................................... 6-10 6.5 Temperature of Fluidics ............................................................................................ 6-10 6.5.1 Introduction to the Thermo System ............................................................. 6-10 6.5.2 Diluent Heating System ...............................................................................6-11 6.6 Reagent Consumption Volume ...................................................................................6-11 6.7 Introduction to Sequences ......................................................................................... 6-12 6.7.1 Analysis Sequence under Whole Blood Mode ............................................ 6-12 6.7.2 Analysis Sequence under Predilute Mode ................................................... 6-15 6.7.3 Introduction to Major Maintenance Sequences ........................................... 6-15 7 Hardware System ..................................................................................................................... 7-1 7.1 Hardware System Function Block Diagram................................................................ 7-1 7.2 Electrical Connection Diagram ................................................................................... 7-2 7.3 Main Control Board .................................................................................................... 7-2 7.3.1 Overview ....................................................................................................... 7-2 7.3.2 Components................................................................................................... 7-3 7.3.3 Debugging and Troubleshooting ................................................................... 7-7 7.4 Power board ................................................................................................................ 7-9 7.4.1 Overview ....................................................................................................... 7-9 7.4.2 Power Board Replacing and Wiring ............................................................ 7-10 7.5 Touch Screen Control Board ......................................................................................7-11 7.5.1 Introduction ..................................................................................................7-11 7.5.2 Components..................................................................................................7-11
3
Table of Contents 7.6
7.7 7.8
7.9
Indicator Board ..........................................................................................................7-11 7.6.1 Introduction ..................................................................................................7-11 7.6.2 Components................................................................................................. 7-12 Motors, Photocouplers and Micro-switches .............................................................. 7-12 7.7.1 Introduction ................................................................................................. 7-12 Liquid Detection Board ............................................................................................. 7-12 7.8.1 Introduction ................................................................................................. 7-12 7.8.2 Components................................................................................................. 7-13 Hardware Troubleshooting ........................................................................................ 7-13 7.9.1 System Error................................................................................................ 7-13 7.9.2 Troubleshooting for Main Control Board.................................................... 7-15 7.9.3 Power Board Errors ..................................................................................... 7-19 7.9.4 Touch Screen Control Board Errors ............................................................ 7-19 7.9.5 Indicator Board Errors................................................................................. 7-20 7.9.6 Motor and Photocoupler Errors ................................................................... 7-21 7.9.7 Liquid detection board error ........................................................................ 7-21
8 Mechanical System................................................................................................................... 8-1 8.1 Introduction to Mechanical Structure .......................................................................... 8-1 8.1.1 Front of the Analyzer..................................................................................... 8-1 8.1.2 Back of the Analyzer ..................................................................................... 8-3 8.1.3 Left Side of the Analyzer .............................................................................. 8-4 8.1.4 Right Side of the Analyzer ............................................................................ 8-5 8.2 Overview of Assemblies ............................................................................................. 8-5 8.2.1 Introduction ................................................................................................... 8-5 8.2.2 Whole Device ................................................................................................ 8-6 8.2.3 Main Unit ...................................................................................................... 8-7 8.2.4 Front Cover Assembly (8.4 in) .................................................................... 8-10 8.2.5 Front Cover Assembly (10.4 inch) ...............................................................8-11 8.2.6 Syringe Assembly........................................................................................ 8-12 8.2.7 Sample Probe Assembly .............................................................................. 8-13 8.2.8 WBC Bath Assembly .................................................................................. 8-14 8.2.9 RBC Bath Assembly.................................................................................... 8-15 8.2.10 Pump Assembly........................................................................................... 8-16 8.2.11 Power Unit .................................................................................................. 8-17 8.2.12 Reagent Detection Assembly ...................................................................... 8-18 8.3 Disassembly and Installation..................................................................................... 8-18 8.3.1 Tools ............................................................................................................ 8-18 8.3.2 Before disassembly ..................................................................................... 8-19 8.4 Removing the Main Unit........................................................................................... 8-20 8.4.1 Remove Left Door Assembly ...................................................................... 8-20 8.4.2 Remove Main Control Board ...................................................................... 8-21 8.4.3 Remove the right door ................................................................................. 8-23 8.4.4 Remove the RBC Bath Assembly ............................................................... 8-23
4
Table of Contents 8.4.5 8.4.6 8.4.7 8.4.8 8.4.9 8.4.10 8.4.11 8.4.12 8.4.13 8.4.14 8.4.15 8.4.16 8.4.17 8.4.18 8.4.19 8.4.20 8.4.21 8.4.22 8.4.23 8.4.24 8.4.25 8.4.26 8.4.27 8.4.28 8.4.29 8.4.30
Remove WBC bath and HGB Light Assembly ........................................... 8-24 Remove Preheating Assembly ..................................................................... 8-25 Remove Right Side Valve Assembly ........................................................... 8-26 Remove Liquid Detection Board PCBA ..................................................... 8-27 Remove Waste Pump................................................................................... 8-28 Remove the Air Pump ................................................................................. 8-28 Remove Vacuum Chamber Assembly ......................................................... 8-29 Remove the Diluent Temperature Sensor .................................................... 8-30 Remove the Top Cover ................................................................................ 8-30 Remove the Aspiration Module................................................................... 8-31 Remove the Motor Horizontal Photocoupler Assembly of Aspiration Module8-32 Replace Sample Probe................................................................................. 8-32 Remove the Probe Wipe .............................................................................. 8-33 Remove the Aspiration Module Photocoupler in Vertical Direction ........... 8-34 Remove the Front Cover Assembly............................................................. 8-35 Remove Indicator PCBA............................................................................. 8-37 Remove the Touch Screen Control Board ................................................... 8-38 Remove the Touch Screen Assembly .......................................................... 8-39 Remove the Touch Screen ........................................................................... 8-39 Remove the Micro-switch Assembly .......................................................... 8-40 Remove the Syringe .................................................................................... 8-41 Remove the Syringe Motor ......................................................................... 8-42 Remove the Syringe Motor Position Photocoupler Assembly .................... 8-43 Replace RBC/WBC Isolation Chamber Filter ............................................. 8-44 Replace Power Unit..................................................................................... 8-44 Remove the Recorder .................................................................................. 8-45
9 Troubleshooting ........................................................................................................................ 9-1 10 Adjustment............................................................................................................................ 10-1 10.1 Adjusting Mechanical Positions ................................................................................ 10-1 10.2 Adjusting Mechanical Positions ................................................................................ 10-3 10.3 Adjusting Analysis Components ............................................................................... 10-4 10.3.1 Preheating Temperature Calibration and Validation .................................. 10-4 10.3.2 Counting Channel Test .............................................................................. 10-5 11 Debugging and Validation After Servicing ..........................................................................11-1 12 Service BOM......................................................................................................................... 12-1 13 Appendices ............................................................................................................................ 13-1 A.
Fluidic diagram ........................................................................................................ A-1
5
Table of Contents B.
Connection and Tube ................................................................................................ B-1
C.
Hardware block diagram......................................................................................... C-1
D.
Cables and Wires ...................................................................................................... D-2
E.
Menu Tree .................................................................................................................. E-3
F.
Appendix Table .......................................................................................................... F-1
6
1Using This Manual 1.1 Overview This chapter describes how to use the service manual. In this manual, the repair methods of BC-20s/BC-30s are described in detail. Before servicing BC-20s/BC-30s, please carefully read and understand the content in order to properly carry out maintenance procedures and ensure the safety of service personnel. This manual must be used in conjunction with the BC-20s/BC-30s Operator’s manual. It does not contain information and procedures already covered in the Operator’s manual of BC-20s/BC-30s.
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 This manual is intended to be read by service professionals who: Have comprehensive knowledge of circuitry and fluidics; Have comprehensive knowledge of reagents; Have comprehensive knowledge of quality control; Have comprehensive knowledge of troubleshooting; Are familiar with the operations of the system; Are able to use basic mechanical tools and understand the terminology; Are skilled users of the digital voltmeter and oscillograph; Are able to analyze the circuit diagrams and fluidic charts.
1.3 Using This Manual This manual comprises 12 chapters and 6 appendices. Refer to the table below to find the information you need. If you want to … learn about BC-20s/BC-30s's physical specifications
See... Chapter 2 Specifications
learn about BC-20s/BC-30s's parameters, respective ranges and test principle
Chapter 3 Operation Principles
learn about interface introduction and upgrading of BC-20s/BC-30
Chapter Interface
1-1
4
Software
and
Using This Manual
learn about BC-20s/BC-30s's external interface settings
Chapter 5 Data Transmission
learn about the composition, dosage, basic channels and time sequence of BC-20s/BC-30s's fluidic system
Chapter 6 Fluidic System
learn about BC-20s/BC-30s's hardware structure; composition, adjusting, testing points and troubleshooting of each board
Chapter 7 Hardware System
learn about BC-20s/BC-30s's structure, disassembly and verification
Chapter 8 Mechanical System
learn about BC-20s/BC-30s's errors and troubleshooting
Chapter 9 Troubleshooting
Debug after BC-20s/BC-30s being serviced
Chapter 10 Debugging
Debugging and verification after BC-20s/BC-30s being serviced
Chapter 11 Debugging Verification After Servicing
learn about BC-20s/BC-30s's service BOM
Chapter 12 Service BOM
learn about BC-20s/BC-30s's fluidic diagrams
Appendix A Fluidic diagrams
learn about BC-20s/BC-30s's fluidic tube connectors
Appendix B Connectors
learn about BC-20s/BC-30s's hardware diagrams
Appendix C Hardware Diagrams
learn about BC-20s/BC-30s's cables and wires
Appendix D Cables and Wires
learn about BC-20s/BC-30s menus and functions for different access levels
Appendix E Menus and Functions of Different Access Levels
/
Appendix F Debugging Verification Record
Lists
of
and
Tube
and
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-20s/BC-30s
××
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 Safety Information You will find the following symbols in this manual. Symbols
Meaning
1-2
Using This Manual read the statement below the symbol. The statement is alerting you to a potentially biohazardous condition. read the statement below the symbol. The statement is alerting
WARNING
you to an operating hazard that can cause personnel injury. read the statement below the symbol. The statement is alerting
CAUTION
you to a possibility of analyzer damage or unreliable analysis results.
NOTE
read the statement below the symbol. The statement is alerting you to information that requires your attention.
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory. If the main unit of the instrument leaks, the leaked liquid is potentially biohazardous.
WARNING It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or injury of human health. Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g. ethanol) around the analyzer. Otherwise, the risk of explosion may exist. 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 the sample probe. Possible mechanical movement of the warned position may lead to personal injury during normal operation, removal, maintenance and verification. Be sure to dispose of reagents, waste, samples, consumables, etc. according to 1-3
Using This Manual 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.
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 When you see... Symbols used in this service manual:
Symbol
Meaning The operator is required to follow the instructions below this symbol. Failure to do so may place the operator at a potential risk of biohazard.
WARNING CAUTION
The operator is required to follow the instructions below this symbol. Failure to do so may cause personal injury. The operator is required to follow the instructions below this symbol. Failure to do so may cause malfunction or damage of the product or affect the test results. 1-4
Using This Manual
NOTE
The operator is required to follow the instructions below this symbol. The instructions will emphasize important information or information that requires particular attention of the operator.
The analyzer system may contain the following symbols:
CAUTION Ensure the labels are in good condition and not damaged while servicing the analyzer.
When you see*
It means* CAUTION, CONSULT ACCOMPANYING DOCUMENTS.
Note: It is recommended that the reader refers to the accompanying documents for important safety information. BIOLOGICAL RISK
WARNING, LASER BEAM
PROTECTIVE EARTH (GROUND)
USB port
Network interface
ALTERNATING CURRENT
FOR IN VITRO DIAGNOSTIC USE
Batch code
1-5
Using This Manual USE BY (YYYY-MM-DD)
Serial number
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
1-6
2 Product Specifications 2.1 Product Name Name: Auto Hematology Analyzer Model: BC-20s, BC-30s BC-20s Appearance
BC-30s Appearance
2-1
2.2 Physical Specifications
Height
Depth Width Table 2-1 BC-20s/ BC-30s
Dimensions and weight
Whole device
BC-20s Dimensions
Length : 295 mm Height : 398 mm (rubber feet included) Depth : 407 mm
BC-30s Dimensions
Length : 295 mm Height : 398 mm (rubber feet included) Depth : 398 mm
Weight
20Kg
2.3 Electrical Specifications Table 2-2 Main unit power supply
Parameter
Value
Voltage
(100V-240V~) ±10%
Input Power
≤300VA
Frequency
50/60±1Hz
Only fuses of specified specification shall be used. Fuse Specification: 250V
3.15A
D5X20 2-2
Product Specifications
2.4 Environment Requirements Operating environment, storage environment and running environment Table 2-3
Overall environment requirements
Operating Environment
Storage Environment
Running Environment
Requirements
Requirements
Requirements
10℃～30℃
-10℃～40℃
10℃～40℃
20%～85%
10%～90%
10%～90%
70kPa～106kPa
50kPa～106kPa
70kPa～106kPa
Ambient Temperature Relative Humidity Atmospheric Pressure
2.5 Product Specifications 2.5.1 Sample mode Two sample modes are provided: whole blood mode, and prediluted mode.
2.5.2 Throughput The throughput of BC-20s in OV-WB/OV-PD is no less than 40 samples/hour; The throughput of BC-30s in OV-WB/OV-PD is no less than 70 samples/h;
2.6 Testing Parameters The analyzer provides quantified results for 21 report parameters (WBC, RBC, PLT, HGB, etc.) and 3 histograms (WBC, RBC, and PLT). See the table below for details. Table 1 Parameters
Name
Abbreviation
White Blood Cell count
WBC
Lymphocyte number
Lymph#
Mid-sized Cell number
Mid#
Granulocyte number
Gran#
Lymphocyte percentage
Lymph%
Mid-sized Cell percentage
Mid%
Granulocyte percentage
Gran%
Red Blood Cell count
RBC
Hemoglobin concentration
HGB
Mean Corpuscular Volume
MCV
Mean Corpuscular Hemoglobin
MCH 2-3
Product Specifications
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
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*
*Note: for BC-30s only. Table 2 Histograms
White Blood Cell Histogram
WBC Histogram
Red Blood Cell Histogram
RBC Histogram
Platelet Cell Histogram
PLT Histogram
2.7 Performance Requirements 2.7.1 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 consecutively for 3 times, the highest value among the 3 results shall meet the requirements in the following table. Table 2-4 Background/blank count requirements
Parameter
Background/blank count requirements 9
WBC
≤ 0.20× 10 / L
RBC
≤ 0.02× 10 / L
HGB
≤1 g/L
HCT
≤ 0.5 %
PLT
≤ 5 × 10 / L
12
9
2.7.2 Carryover Carryover refers to the transfer of blood cells from high concentration sample to low concentration sample. Verification method: Prepare a high concentration sample (centrifuged high value control or special high value linearity control) which is within the range specified in Table 2-6, mix and then test it 2-4
Product Specifications consecutively for 3 times, and 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 2-6, test it consecutively for 3 times, and the test results are j1, j2, and j3. Calculate the carryover according to the following equation, and the result shall meet the requirements in Table 2-5.
Table 2-5 Carryover Requirements
Parameter
Carryover WBC
≤0.5％
RBC
≤0.5％
HGB
≤0.6%
PLT
≤1.0%
Table 2-6 Sample Concentration Range of Carryover Test
Parameter WBC RBC HGB PLT
Unit
High concentration range
Low concentration range
9
> 15.00
< 3.00
12
> 6.00
< 1.50
> 200
< 50
> 300
< 30
×10 /L ×10 /L g/L 9
×10 /L
2.7.3 Repeatability Test a sample which meets repeatability requirement on the analyzer consecutively for 10 times, calculate the CV(%) and absolute deviation (d) of each parameter, and the results shall meet the requirements in the following table.
In the equation:
s ----standard deviation of sample test results; x ----mean value of sample test results;
xi
----actual test result of the sample;
d ----absolute deviation of the sample test results. Table 2-7 Whole Blood Repeatability Requirements 2-5
Product Specifications
Parameter
Whole Blood Repeatability (CV/absolute deviation d)
Predilute Repeatability (CV/absolute deviation d)
4.0 ~ 6.9 × 10 / L
≤2.0％ ≤ 3.5
≤4.0％
≤1.5%
≤2.0%
HGB
3.50 ~ 6.50 × 1012 / L 100 ~ 180 g/L
≤1.5%
≤2.0%
MCV
70.0～110.0 fL
≤1.0%
≤1.5%
WBC RBC
Condition 7.0～15.00× 109 / L 9
100 ~ 149 × 10 / L
≤5.0%
150 ~ 500 × 10 / L
≤4.0%
9
PLT
≤8.0%
9
HCT Lymph%
30～50% Lymph%≥15% WBC≥4.0×109/L
/
≤ 2.5
≤12%
≤12%
Mid%
Mid%≥5% WBC≥4.0×109/L
≤25%
≤25%
Gran%
Gran%≥30% WBC≥4.0×109/L
≤12%
≤12%
RDW-CV
-
≤3.5%
≤3.5%
RDW-SD
-
≤3.5%
≤3.5%
MPV
-
≤4.0%
≤5.0%
2.7.4 Linearity Linearity was determined by running diluted samples. Samples of different concentrations were tested in both whole blood and predilute modes; the slope and intercept were calculated per the linear regression equation, and then the deviation between the theoretical value and test result was obtained, which shall meet the requirements in the following table. Table 2-8 Linearity Requirements Para
Linearity Range
meter WBC
Deviation Range (Whole Blood)
0.0～100.0×109/L
Deviation Range (Predilute)
9
±0.30×10 /L or 5％
±0.50×109/L or 5％
( for both BC-20s and BC-30s) 100.1～200.0×109/L
±9％
±18%
(for BC-30s only) RBC
0.0～8.00×1012/L
±0.05 × 1012/L
or
±0.05 × 1012/L
±5％
±5％
or
HGB
0～280g/L
±2g/L or ±2％
±2g/L or ±3％
PLT
0～1000×109/L
±10×109/L or ±10%
±10×109/L or ±10%
±12%
±20%
( for both BC-20s and BC-30s) 1001 ~ 4000×109/L (for BC-30s only)
2-6
Product Specifications HCT
0~67%
±4% (HCT value) 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.
2.8 Display Range 2.
Table 2-9 Display Range
Parameter
Display Range
WBC
0.00×10 /L～999.99×10 /L
RBC
0.00×10 /L～18.00×10 /L
HGB
0 g/L～300g/L
PLT
0×10 /L～9999×10 /L
HCT
0%~80%
9
9
12
12
9
9
2.9 Product Description BC-20s/BC-30s Auto Hematology Analyzer is mainly composed of the analysis module, information management module, result output module and accessories. Figures, pictures and drawings in this manual are prepared based on BC-30s, of which the structure is basically the same as that of BC-20s.
The analyzer is heavy. Do not try to carry it by oneself, or serious injury may be caused. It requires at least two persons to transport the analyzer. Use necessary tools if possible.
2-7
Product Specifications
Figure 2-1 Front of the analyzer
1 ----Display screen 3 ----Probe wipe block 5 ----[Aspirate] Key
2 ---- Power/status indicator 4 ----Sample probe
Figure 2-2 Back of the analyzer
2-8
Product Specifications
1 ---- USB interface 3 ---Power input socket 5 ---Waste outlet
2 --- Network interface 4 --- Waste sensor connector 6 --- M-3D diluent inlet
Figure 2-3 Left side of the analyzer
1 --- Recorder
2 --- Side door
2.9.1 Main unit The main unit performs sample analysis and data processing. It is the main part of the instrument.
2.9.2 Power/status indicator The power/status indicator locates at the middle position, right side of the front panel on the main unit. It tells you about the status of the analyzer including ready, running, error, standby and on/off, etc.
2.9.3 Power input connector The power input socket is at the back of the main unit. It is used to turn on or off the analyzer.
CAUTION Once you turn on/off the analyzer, do not operate the power switch again in 10 seconds, or it may cause damage to the analyzer.
2-9
Product Specifications
2.9.4 [Aspiration] Key The [Aspiration] key locates at the front panel of the analyzer, in the middle part of the right side. It is used to start the analysis, dispense diluent or exit the standby mode.
2.9.5 USB ports The analyzer has 4 USB ports on the left panel of the main unit to connect peripherals and transmit data.
2.10 Product Configuration By standard configuration, the instrument includes the main unit, standard accessories and the reagents. We also provide external barcode scanner and printer as optional accessories. Connect the printer through the USB ports. Supported printer models include: EPSON LQ-590K,HP Laser Jet P1505n, HP OfficeJet Pro K5300, and HP LaserJet P1606dn.
2.11 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 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 any sign of leakage or moisture is found, do not use the reagent.
Store and use the reagents as instructed by instructions for use of the reagents. When you have changed the diluent, lyses, 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.
2.11.1 Reagents M-30PD diluent
M-30PD diluent is formulated to dilute the blood samples. It is used to determine the count and size distribution of blood cells and the measurement of HGB. M-30PCFL lyse 2-10
Product Specifications
M-30PCFL lyse breaks down the red cells and achieve WBC 3-part differential. Probe Cleanser
Probe Cleanser is used for the regular cleaning of the analyzer
2.11.2 Reagent Consumption Volume Table 2-10 Reagent Consumption Volume Sample Presentation Mode
Diluent (ml)
Lyse(ml)
Probe Cleanser (ml)
Whole blood mode
19.96
0.31
0
Predilute mode
19.93
0.31
0
Dispensing diluent
1.4
0
0
Shutdown
36.1
0
1
44.04
0
Exit standby1
4.29
0
0
Exit standby2
33.28
0
0
Exit standby3
44.04
0
0
Exit standby4
44.35
0.31
0
Startup (exclude the consumption during background check)
2.11.3
0
Controls and Calibrators
The controls and calibrators are used for the analysis quality control and calibration of the analyzer. The controls are suspension of stimulated human blood, specifically manufactured to monitor and evaluate the analysis precision of the analyzer. The controls are prepared with three levels, namely low, normal and high. The calibrators are also suspension of stimulated human blood, specifically manufactured for the calibration of the analyzer, so as to build the metrological traceability of analysis results. For the use and storage of controls and calibrators, please refer to the Instruction for Use of each product. All references related to the controls and calibrators in this manual refer to the "controls" and "calibrators" Mindray specifically formulated for BC20s/30s by Mindray.
2.1. Information Storage Capacity Table 2-11
Data storage requirements
Data storage capacity
BC-20s: no less than 200,000 samples BC-30s: no less than 500,000 samples
Information
The information stored should at least include the following: (histogram), sample information, patient information, flags as well as any special information of the analyzer.
2-11
3 System Principles 3.1 Introduction The analyzer uses the electrical impedance method to determine the count and size distribution of RBC, WBC and PLT; and uses the colorimetric method to determine HGB. Based on the above data, the analyzer calculates other parameters.
3.2 Analyzer Workflow We have defined the whole operation workflow of the analyzer by its major functions: reagent system, sample loading and distribution, sample preparation, sample measurement, signal processing, parameter analysis, status monitoring, scheduling control and information processing, man-machine interface, power as well as cleaning and maintenance. The relationships between the functions are illustrated as below:
The scheduling control and information processing module coordinates and regulates other functional modules to work by defined process and requirements, so as to ensure the completing of sample measurement, the ultimate task of the analyzer.
3-1
System Principles
3.3 Aspiration If you are to analyze a whole blood sample, present the sample to the analyzer directly, and the analyzer will aspirate 9 μL of the whole blood sample. If you are to analyze a capillary blood sample under the pre-dilute mode, you should first manually dilute the sample (20 μL capillary sample needs to be diluted by 0.7 mL of diluent to form a 1:36 dilution), and then present the pre-diluted sample to the analyzer, which will aspirate 198uL of the sample.
3.4 Dilution Usually in blood samples, the cells are too close to each other to be identified or counted. For this reason, the diluent is used to separate the cells so that they draw through the aperture one at a time as well as to create a conductive environment for cell counting. Moreover, red blood cells usually outnumber white blood cells by 1,000 times. Because red blood cells usually have no nucleus, they are eliminated when the lyse breaks down their cell walls. For this reason, lyse need to be added to the sample to eliminate the red cells before the WBC counting. The analyzer provides whole blood mode and predilute mode for the analysis of different sample types.
3.5 WBC Measurement 3.5.1 Measurement Principle: WBC measurement principle
The WBCs are counted by the impedance method. The analyzer aspirates certain volume of sample, dilutes it with certain volume of conductive solution, and delivers the dilution to the metering unit. The metering unit has a little opening which is called "aperture". A pair of electrodes is positioned on both sides of the aperture, and creates a constant-current supply. As cells are poor conductors, when each particle in the diluted sample passes through the aperture under the constant negative pressure, a transitory change in the direct-current resistance between the electrodes is produced. The change in turn produces a measurable electrical pulse which is proportional to the particle size. And when the particles pass the aperture in succession, a series of pulses are produced between the electrodes. The number of pulses generated indicates the number of particles passed through the aperture; and the amplitude of each pulse is proportional to the volume of each particle. Each pulse is amplified and compared to the internal reference voltage channel, which only accepts the pulses of certain amplitude. All the collected pulses are thus classified based on the reference voltage ranges of different channels, and the number of the pluses in the WBC channel indicates the number of the WBC particles. The cell size distribution width is represented by the number of particles falling in each channel.
3-2
System Principles
Figure 3-1 Metering diagram
3.5.2 WBC-Related Parameters White Blood Cell count
WBC (109/L) is the number of leukocytes measured directly by counting the leukocytes passing through the aperture. Sometimes there are nucleated red blood cells (NRBC) presenting in the sample. While the lyse will not be able to break their nuclear membrane, these NRBCs will also be counted as WBCs. Therefore when NRBCs are found during microscopic exam, follow below formula to modify the WBC count:
In the formula, WBC′ is corrected WBC count result; WBC is the WBC count provided by the analyzer; and NRBC indicates the number of NRBCs found when every 100 WBCs are counted.
3-DIFF of WBC
Lyses and diluents change the sizes of each type of WBCs in various ways and at different time. The WBCs are thus separated into 3 parts (from the largest size to the smallest): lymphocytes, mid-sized cells (including monocytes, eosinophils, and basophils) and granulocytes. The analyzer then calculate the lymphocyte percentage (Lym%), mid-sized cell percentage (Mid％) and granulocyte percentage (Gran%) (All presented in %) based on the WBC histograms and in accordance with below formulae:
3-3
System Principles
In the formulae: PL indicates the number of cells falling in the lymphocyte region, PM the number of cells falling in the mid-sized cell region, and PG the number of cells falling in the granulocyte region. All three parameters are presented in 109/L. When the three percentages are obtained, the analyzer automatically proceeds to calculate the lymphocyte number (Lym#), mid-sized cell number (Mid#) and granulocyte number (Gran#) by below formulae , all parameters expressed in 109/L.
Lym％, Mid％ and Gran％ are expressed in %, while WBC is in 109/L. White blood cell histogram
Besides the count results, the analyzer also provides a WBC histogram which shows the WBC size distribution, with the x-axis representing the cell size (in fL) and the Y-axis representing relative cell number (in 109/L)(as shown below). The WBC histogram of a normal blood sample (lysed and processed) should show display 3 clear parts: the small cell (about 20~70fl) region represents the LYM group (lymphocytes); the mid-sized cell (about 70~150fl) region represents the Mid group (including monocytes, eosinophils and basophiles); and the large cell (over 150fl) region represents the Gran group (granulocytes).
3-4
System Principles
After each analysis cycle, you can either check the WBC histogram in the analysis result area on the "Sample Analysis" screen or review the histogram on the "Review" screen.
3.5.3 HGB Measurement The HGB is determined by the colorimetric method. The diluted sample is delivered to the WBC count bath where it is bubble mixed with a certain amount of lyse, which breaks red blood cells, and converts hemoglobin to a hemoglobin complex. An LED is mounted on one side of the bath and emits a beam of monochromatic light with 530~535nm central wavelength of 530~535nm. The light is received by an optical sensor mounted on the opposite side, where the light signal is first converted to current signal and then to voltage signal. The voltage signal is then amplified and measured and compared to the blank reference reading (reading taken when there is only diluent in the bath), and the HGB (g/L) is measured and calculated automatically. The whole measurement and calculation process is completed automatically. You can review the results in the analysis result area on the "Sample Analysis" screen. HGB is expressed in g/L.
Blank Photocurrent HGB(g/L) = Constant × Ln Sample Photocurrent
3.6 RBC/PLT Measurement 3.6.1 Impedance Method RBCs/PLTs are counted by the electrical impedance method. The analyzer aspirates certain volume of sample, dilutes it with certain volume of conductive solution, and delivers the dilution to the metering unit. The metering unit has a little opening which is called "aperture". A pair of electrodes is positioned on both sides of the aperture, and creates a constant-current supply. As cells are poor conductors, when each particle in the diluted sample passes through the aperture under the constant negative pressure, a transitory change in the direct-current resistance between the electrodes is produced. The change in turn produces a measurable electrical pulse which is proportional to the particle size. And when the particles pass the aperture in succession, a series of pulses are produced between the electrodes. The number of pulses generated indicates the number of particles passed through the aperture; and the amplitude of each pulse is proportional to the volume of each particle. Each pulse is amplified and compared to the internal reference voltage channel, which only accepts the pulses of certain amplitude. All the collected pulses are thus classified based on the reference voltage thresholds of different channels, and the number of the pluses in the RBC/PLT channel indicates the number of the RBC/PLT particles. The cell size distribution width is represented by the number of particles falling in each channel.
3-5
System Principles
Figure 3-2 Metering diagram
3.6.2 RBC-Related Parameters Red Blood Cell count
RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes passing through the aperture.
Mean Corpuscular Volume
The analyzer calculates the mean cell volume (MCV, in fL) based on the RBC histogram.
HCT, MCH and MCHC
The hematocrit (HCT, %), mean corpuscular hemoglobin (MCH, pg.) and mean corpuscular hemoglobin concentration (MCHC, g/L) are calculated as follows:
Where RBC is expressed in 1012/L, MCV is expressed in fL and HGB is expressed in g/L.
3-6
System Principles RDW-CV
Red Blood Cell Distribution Width - Coefficient of Variation (RDW-CV) is derived based on RBC histogram. It is expressed in %, and indicates the variation level of RBC size distribution.
RDW-SD
Red blood cells distribution width - standard deviation (RDW-SD, in fL) measures the width of the 20% level (with the peak taken as 100%) on the RBC histogram, as shown in Figure 3-3.
Figure 3-3 Red blood Cell Histogram
Besides the count results, the analyzer also provides a RBC histogram which shows the RBC size distribution, with the x-axis representing the cell size (in fL) and the Y-axis representing relative cell number (in 1012/L)(as shown below). With a normal blood samples, the RBCs mostly fall in the region of 70~120fl.
After each analysis cycle, you can either check the RBC histogram in the analysis result area on the "Sample Analysis" screen or review the histogram on the "Review" screen.
3.6.3 PLT-Related 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).
PDW 3-7
System Principles
Platelet distribution width (PDW) is derived from the platelet histogram, and is reported as 10 geometric standard deviation (10 GSD).
PCT
The analyzer calculates the PCT (％) as follows: where the PLT is expressed in 109/L and the MPV in fL.
Platelet-Large Cell Ratio
The analyzer calculates the number of platelets larger than 12fl in size based on the platelet histogram and then derives the large platelet ratio (％). Platelet Histogram
Besides the count results, the analyzer also provides a PLT histogram which shows the PLT size distribution, As shown in below, most PLTs of a normal blood sample should fall into the 0~20fl region. with the x-axis representing the cell size (in fL) and the Y-axis representing relative cell number (in 109/L).
After each analysis cycle, you can either check the PLT histogram in the analysis result area on the "Sample Analysis" screen or review the histogram on the "Review" screen.
3.7 Wash After each analysis cycle, each element of the analyzer is washed: The sample probe is washed internally and externally with diluent; The baths are washed with diluent; Other elements of the fluidic system are also washed diluent.
3.8 Troubleshooting 3.8.1 Flags The analyzer provides 26 algorithm flags. Refer to below table for flag meanings and conditions. 3-8
System Principles
Flag type
Flag Message
Indication
Conditions
WBC Histogram R1
Possible presence of platelet coagulation, large platelets, nucleated red blood cells (NRBC), red cells which are not broken down, protein with large molecular weight and lipid particulars. It may also suggest electrical noise interference.
Abnormal cell size distribution of WBC histogram in the left of the LYM region
WBC Histogram R2
Possible presence of atypical/abnormal lymphocytes, plasma cells and blasts. Or extra-high numbers of eosinophils and basophiles.
Abnormal cell size distribution of WBC histogram in the region between the lymphocyte peak and the mid-sized cell region.
WBC Histogram R3
Possible presence of immature cells and blasts; or eosinophilia.
Abnormal cell size distribution of WBC histogram in the region between the mid-sized cell region and the granulocyte peak.
WBC Histogram R4
Possible presence of large immature cells, blasts, WBC agglutination or high absolute number of granulocyte.
Abnormal cell size distribution of WBC histogram in the right of the granulocyte peak.
WBC Histogram Rm
More than one abnormal cell size distribution type exists.
At least 2 WBC histogram R flags are reported.
Abnormal WBC size distribution
WBC histogram R flag is reported
Abnormal WBC histogram
Leucopenia
Low WBC count
WBC < 2.50×10^9/L
Leucocytosis
High WBC count
WBC > 18.00×10^9/L
Granulopenia
Low granulocyte count
GRAN# < 1.00×10^9/L
Granulocytosis
Low granulocyte number
GRAN # > 11.00×10^9/L
lymphopenia
Low lymphocyte number
LYMPH# < 0.80×10^9/L
Lymphocytosis
High lymphocyte number
LYMPH# > 4.00×10^9/L
High mid-sized cell number
High mid-sized cell number
MID# > 1.80×10^9/L
Pancytopenia
Low WBC, RBC and PLT count
WBC < 4.0×10^9/L and RBC < 3.5 ×10^9/L and PLT < 100×10^9/L
Abnormal RBC size distribution
Possible presence of microcytosis, macrocytosis, anisocytosis, RBC
Abnormal RBC histogram
WBC
RBC
3-9
System Principles
agglutination and diamorphologic histogram.
PLT
HGB Abn./Interfere?
HGB results may be abnormal or interference may exist (for example, high WBC count)
MCHC > 380 g/L or interfering parameters of HGB exceed allowable ranges
Microcytosis
Small MCV
MCV < 70fL
Macrocytosis
Large MCV
MCV > 110fL
Anemia
Anemia
HGB < 90g/L
Erythrocytosis
High RBC count
RBC > 6.5×10^12/L
PLT Histogram Ps
High number platelets.
of
small
PLT Histogram P1
High number platelets.
of
large
PLT Pm
Possible presence of microcytosis, RBC debris, large platelet and platelet coagulation.
The boundary of the PLT/RBC is too confusing for the system to define.
Platelet distribution abnormal
Abnormal PLT histogram
PLT histogram Pm flag is reported
Thrombopenia
Low PLT count
PLT < 60×10^9/L
Thrombocytosis
High PLT count
PLT > 600×10^9/L
Histogram
PLCR < 15% PLCR > 50%
3.8.2 Shielding Protocol Refer to the table below to see how related parameters will be marked when a certain flag is reported. Flag type
WBC
RBC
Flag Message
Shielding Relation
Abnormal WBC size distribution
R/？* : WBC and infected WBC differential parameters. Different WBC parameters may be marked by R or * depending on different situations.
Leucopenia
/
Leucocytosis
/
Granulopenia
/
Granulocytosis
/
lymphopenia
/
Lymphocytosis
/
High mid-sized cell number
/
Pancytopenia
/
Abnormal RBC size distribution
Infected parameters marked by R/？ : RBC, HCT, RDW－CV, RDW－SD etc. Different RBC parameters may be marked
3-10
System Principles
depending on different situations.
PLT
HGB Abn./Interfere?
Infected parameters marked by R/？ : HGB, MCH and MCHC.
Microcytosis
/
Macrocytosis
/
Anemia
/
Erythrocytosis
/
Platelet distribution abnormal
size
Infected parameters marked by R/？ : PLT, MPV, PDW, PCT, PLCR and PLCC.
Thrombopenia
/
Thrombocytosis
/
3-11
4 Software and Interface 4.1. Login 4.1.1 User ID and Password for Service Level Access User ID: Service Password: Se s700 (note there is a blank space between Se and s700).
NOTE Password is case sensitive.
4.1.2 System Self-test When Logging in at Service Access Level When you log in at service access level, the analyzer will automatically run a check matching the backup data on the board card with the data in the SD card. If the board card or SD card has been replaced before, or the analyzer detects configuration change before abnormal shutdown, you will be prompted to restore the system or back up data.
Figure 4-1 System self-test prompt Tap "OK" to enter the
screen and follow the instructions to enter below screen and follow the
instruction to backup and restore the data:
4-1
Software and Interface
Figure 4-2 Backup and restore data
1) When the SD card has been replaced, follow the instruction and "restore" the important parameters to the new SD card. 2) When the main control board has been replaced, follow the instruction and "backup" the data to the new main control board,
NOTE Always perform the shutdown procedure before replacing the SD card or main control board, so the data will be automatically backed up.
4-2
Software and Interface
4.2 Review 4.2.1 Trend Graph
Figure 4-3 Trend graph screen When the mean value of the selected parameter results are calculated, then the ordinates corresponding to the mean value point, the upper limit point and the lower limit point are Mean, Mean + Mean * 10%, and Mean – Mean * 10%. Calculate the upper or lower limit of certain parameter result by "Mean+Deviation". If a result does not confirms to the acceptable data format, round it up to get the corresponding ordinates. Tap the "Setup" button on the trend graph screen to enter the parameter limit setup screen (as shown below):
4-3
Software and Interface
Figure 4-4 Setting up parameter limits
4.3 Calibration 4.3.1 Calibration Factors Calibration is performed to ensure the analyzer may deliver accurate sample analysis results. During the calibration process, a calibrator factor will be calculated. This factor will be used to multiply with the analysis results to output the final results. When running a calibrator, the analysis results after being adjusted by the factor should be as close to its assigned targets. Thus the calibrator factor is derived by below formula:
Calibration with fresh blood includes two modes of "WB" and "PD", which use different fluidic sequences. Perform calibration for each of the two modes separately. Besides the calibration factor of the manufacturer, the factor of the users is also used to calculate the results. For example ,under the CBC+DIFF mode, the final analysis results output by the analyzer are calculated as follow:
Only the 5 traceable parameters are used in the calibration including: WBC, RBC, HGB, MCV and PLT. 4-4
Software and Interface
CAUTION When you perform calibration at the service access level, the calibration factors of manufacturer will be modified, and the calibration factors of user will change to 100.00%.
4.3.2 Calibration with Calibrator
Figure 4-5 Calibration at Service Access Level When performing calibration with calibrator at service access level, the analyzer calculates all factory calibration factors automatically. You need to run at least 5 calibrations to calculate and save calibration factors. When 10 calibrations are done, a dialog box will be displayed prompting that calibration has been completed; and you will be prompted to save the new calibration factors when exiting the screen. Before calibration, make sure to set up the lot numbers, expiration dates, analysis modes and the target values for the calibrators. The calibration factors should fall into the range of [75%, 125%].
CAUTION Never use expired calibrators.
4-5
Software and Interface
NOTE If the calibrated factors or CVs are out of allowable range, they will be displayed in red, and the values cannot be saved.
4.4 Sample Probe Debug The action is performed to test if the sample probe may properly move to each position.
Figure 4-6 Sample Probe Debug
When you enter the "Sample Probe Debug" screen, press the "Initialize" button first. The sample probe debugging will only start after initialization. For details, please refer to Section 10.2 Adjustment of Mechanical Positions.
4.5 Temperature Calibration The action is performed to make sure the temperature values reported by temperature sensors are as close to the actual temperature as possible, so as to ensure the analysis accuracy.
4-6
Software and Interface
Figure 4-7 Temperature Calibration As you can see from the figure above, four values are displayed on this screen, namely Total difference, New difference, Machine measurement value and Meter measurement value. Machine measurement value refers to the temperature displayed on the "Temp & Pressure screen", while the "Meter measurement" displays the temperature measured by thermograph. "Total difference" and "New difference" are calculated values. However, the real measured value, which is measured by the temperature sensor, is also used but not displayed.
Enter the "Meter measurement" value and tap "Calculate new diff." to get the new difference. New difference = Meter measurement – Real measurement Tap "Save" to assign the new difference value to the "Total difference", e.g., Total difference = New difference. Machine measurement = Real measurement + Total difference
4.6 Gain Calibration The function is used to calibrate the gains for the RBC, WBC and HGB parameters, including MCP, WCP, HGB, RBC effective width and WBC effective width. The purpose is to ensure each channel may deliver reliable results.
4-7
Software and Interface
Figure 4-8 Gain Calibration
You can calibrate the gain factors for all parameters displayed above at the same time. Among the parameters, the WBC/RBC effective width is calibrated by software with averaging method. Tap the "Select" boxes to select the results used to calculate the mean values. WCP, MCP and HGB gains instead are hardware gains and calibrated with successive "approximation method". They are not affected whether any group of results is "selected". Invalid calibration results will be displayed in red. In this case, do the calibration again. If the target of a parameter is not set, the parameter will not be calibrated (like MCP on above figure). The system will ask if you want to save the calibration factors when exiting the Gain Calibration screen.
CAUTION The function only supports the calibration with calibrators. Never use expired calibrators. Refer to the calibrator target sheet provided manufacturer.
4.7 Gain Setup You can set up the gain for HGB on the "Gain Setup" screen. Gains for other parameters are obtained by gain calibration and cannot be edited.
4-8
Software and Interface
Figure 4-9 Gain Setup As the HGB gain is hardware gain, you will be adjusting digital potentiometer when you setup it. Tap the "Auto Cal. to 4.2V" button, and the HGB blank voltage will be set to 4.2V automatically.
NOTE As the gain settings affect the validity of analysis results, be careful when you adjust them.
4-9
Software and Interface
4.8 Performance 4.8.1 Background Count
Figure 4-10 Background count Enter the "Background count" screen and press the [Aspirate] key to start background count. You do not need to run actual samples. The background is acceptable only when all the result boxes display "pass" on the background count screen.
4-10
Software and Interface
4.8.2 Reproducibility
Figure 4-11 Reproducibility test Test a sample which meets reproducibility requirement on the analyzer for 10 times, and calculate the CV (%) and absolute deviation (d) of each parameter, and the results shall meet the reproducibility requirements.
NOTE End users usually use normal controls to calculate the reproducibility.
4-11
Software and Interface
4.8.3 Carryover
Figure 4-12 Carryover test Make sure the analyzer is working properly and steadily. Run a high value sample consecutively for 3 times and then run a low value sample consecutively for 3 times. Calculate the carryover per below formula:
Carryover(%) =
First low - level sample result－Third low - level sample result × 100％ Third high - level sample result－Third low - level sample result
4.9 Advanced Toolbox The "Advanced Toolbox" provides three functions: software update, language switch and data export. (see below).
4-12
Software and Interface
Figure 4-13 Advanced toolbox
4.9.1 Language Setup The analyzer supports the Chinese and English languages.
NOTE When you change the language setting, the new language will only become effective after restart.
4.9.2 One-key Export You can use this function to export instrument information, software debug information, reproducibility test results, accuracy test results, factory calibration results, background test results, carryover results, aging data, as well as gain calibration results, system self-test results, version information, configuration information, inf. files, and user operation logs. The exported Spec Info folder only contains an AllSpecialInfo.csv file.
NOTE The USB should have been formatted to FAT32 before you copy and paste the "update" directory to it.
4-13
Software and Interface Recommended USB models: Kingston 8/16G, SanDisk 8/16G and Maxell 4/8G. Make sure there is enough free space (at least 4G) on the USB.
4.10 Software Update Prepare the USB for update Unzip the file named "update.tar.gz", and then copy the "update" directory in the unzipped file to the root directory of the formatted USB.
NOTE The USB should have been formatted to FAT32 before you copy and paste the "update" directory to it. When the USB is ready, it should have an "update" folder under the root directory, and the "update" folder further contains two sub-folders named "step1" and "step2". Update Insert the USB to one of the USB ports on the analyzer, and perform update following either of the below methods: Advanced Toolbox-Start Update
Figure 4-14 Advanced toolbox: update 4-14
Software and Interface Version Info.- Start Update
Figure 4-15 Version Info.: Update The "Update" process includes two steps: Step 1: update the guide and operation system; Step 2: update the software module. If the update guide and the operation system also need to be updated, the system will prompt you to restart the analyzer between step 1 and step 2; if only the software module need to be updated, the update will start from step 2 directly.
CAUTION Do not pull the USB or disconnect power during the update; otherwise the analyzer may not start.
NOTE The update usually takes about 10 minutes but depends on the number of modules to be updated. Do not leave the analyzer as the process requires user operation.
When update fails If the update fails, try again. 4-15
Software and Interface
4.11 Status Indicator The indicator on the front panel of the analyzer may light in 3 colors. When it flickers, it flickers at the frequency of 2 seconds. The relationships between the indicator status and the analyzer status are listed below: Table 4-1 Status indicator
Analyzer status
Indicator
Remarks
Ready
Static green
Waiting for actions
Running
Flickering green
Performing actions
Running with error
Flickering red
Running, but there is/are error(s)
Error and not running
Static red
There is/are error(s), and the analyzer is not running
No error, but fluidic actions are not
Static yellow
Startup initialization or standby,
allowed
not involving fluidic actions
Enter/exit standby
Flickering yellow
Enter/exit standby
4.12 Buzzer When there is any error, the buzzer gives out an alarm sound. Tap the touch screen to silent the buzzer; or when the errors are removed the alarm sound will stop automatically. The buzzer also sounds in other ways indicating different system status. Table When...
4-2 Buzzer sounds The
buzzer
Remarks
sounds Startup process completed
a short beep
Startup process is completed when the analyzer is started and ready for analysis
Sample
presentation/aspiration
2 short beeps
under open-vial mode is completed On the analysis related screens
A long beep
When there are dialog boxes
(e.g. screens of sample analysis,
popped out prompting further
QC,
carryover,
action,
or
sound.
reproducibility,
background,
aging
gain
the
buzzer
may not
calibration), press the [Aspiration] key to start analysis Error
Long
beeps
4-16
at
Tap the "Remove error" button to
Software and Interface
Analyzer ready
intervals
silent the buzzer
1 short beeps
Analyzer gets ready from other status
The
analyzer
screen
becomes
Silent
When there is/are error(s) during
black, and prompts "Please turn off
shut down process, the buzzer
the power of the analyzer!"
stops when the analyzer screen becomes black.
4-17
5 Data Transmission 5.1 LIS Connection Communication Setup (Menu > Setup > System Setup > Communication) You can set the following on the "Communication" screen: Network communication Serial interface communication Transmission Mode
5.1.1 Network communication
Figure 5-1 Communication setup Network Types Network type: supports both "Wireless" and "Wired" devices. Wireless network card chip: rtl8192cu Recommended network card models:
NETGEAR: WNA3100M； EDUP：EP-N8508GS. When using a wired network, you only need to set up the protocol; when using a wireless network, insert the wireless network card, and tap the button on the right of the "Network Type" pull 5-1
Data Transmission down list. Then set the Wi-Fi on the popped-out dialog box.
Figure 5-2 Wi-Fi connection setup Protocol Setup
IP Address: Setup the IP for the analyzer; 10.0.0.2 by default Subnet mask: Subnet mask for the analyzer network; generally being 255.255.255.0 Default gateway: Gateway IP Mac Address: The Mac address of the analyzer is fixed by manufacturer and cannot be changed. Communication protocol:
Tap the pull down list to select a suitable communication protocol.
ACK Synchronous Transmission:
Tap the "ACK synchronous transmission" check box to activate the function. When the function is activated, ACK overtime is 10 seconds by default.
NOTE The IP address for the analyzer is assigned statically. Ask your network administrator for the
5-2
Data Transmission IP address to avoid IP conflict. If the communication involves more than one subnet, ask your network administrator for correct subnet mask and gateway. Ensure the wireless network card is properly inserted before setting up the Wi-Fi network.
5.1.2 Serial Interface Communication The 3008 serial interface communication uses the USB-serial method. Ensure the USB-serial cable is properly connected before setup. Network Types
Chip model: FTDI-FT232.
Figure 5-3 Serial communication setup Protocol Setup
Baud rate: the transmission rate for serial communication; 19200 by default; Check Bit: parity bit, empty by default; Data Bit: 8 by default; Stop Bit: 1 by default; Comm Protocol: support HL7, 8ID and 10ID serial communication protocols
5-3
Data Transmission
5.1.3 Transmission Mode You can choose to select the functions based on your needs by tapping on the check boxes. Auto Retransmit The option can only be activated when the "ACK Synchronous Transmission" check box is checked. When "Auto Retransmit" is selected, if ACK is not received in specified time, the software will automatically re-send the data. Auto Communicate When the option is selected, software will automatically send the sample information and analysis results to the LIS. Transmit as Print Bitmap Data When the option is selected, the histograms will be sent to LIS as printed data with white background.
Histogram transmitted as
Select the histogram transmission method from the pull down list: Not to be transmitted Histograms will not be transmitted when this option is selected. Bitmap When this option is selected, the histograms will be transmitted in the format of bitmap to LIS. Data When this option is selected, histograms will be transmitted to LIS as digital data in Mindray-specified format and only can be reviewed with Mindray data management software
5-4
Data Transmission
5.2 Setup of Data Management Software 5.2.1 Communication Parameter Setup
Figure 5-4 Communication Parameter Setup on Data Management Software As seen on above figure, the IP address and protocol should be set as the same as those of the analyzer. The port is fixed to be 5100.
5-5
Data Transmission
5.2.2 Communication Instrument Management
Figure 5-5 Communication Instrument Management with Data Management Software Set the analyzer as server, and LIS and the data management software as the client. The connection must be initialized from the client.
5.3 Troubleshooting for Communication Errors Physical connection Check whether the network cable is properly connected; and whether the network physical connection is correct.
Communication setup Check whether the network settings (including the communication setup for both analyzer and LIS) are correct.
Network firewall To check whether there is a network firewall, open the network connection licenses for LIS, data management software and the 5100 port.
5-6
6 Fluidics 6.1 Introduction to Fluidic Parts 6.1.1 Mindray valves Symbol:
2-way valve
3-way valve
Appearance:
2-way valve
3-way valve
Spring pole Function: 2-way valve: to build up or cut off a passage. When power off, the passage from the inlet of the valve to outlet is cut off; when power on, the passage is built up. 3-way valve: to switch among passages. When power off, the public end and the NO (normally open) end are connected; when power on, the public end and the N.O.(normally open) end are connected. Note: the operating voltage of Mindray valves is 12V, and maximal bearable pressure is 200KPa. The internal movement of the valves is driven by electromagnet and the restoration is driven by the spring, so it is recommended not put the valves power-on for too long. When the electromagnet valve is working, the spring pole will lower down, and it will rise to the initial position when power off. You can touch the spring pole and feel the descending or ascending, in order to determine whether it is in action.
6-1
Fluidics
6.1.2 LVM fluidic valve Symbol
Same as Mindray valves Appearance
3-way LVM fluidic valve
Function: same as of the Mindray valves. Compared with the 2-way valve, this valve bears higher pressure and has a pump with smaller action volume; so it may adapts to more strict flow control and greater temperature and pressure changes in Note: the maximal bearable pressure of the LVM fluidic valve is 200KPa, and the CV of the flow is about 0.03. The SV02 in the fluidic charts is LVM fluidic valve.
6.1.3 Linkage Syringe Device Symbol: SR
Function: the linkage syringe device, driven by a motor and a unit of driving assembly, consists of two syringes: one with a high dispensing volume, the other with a low dispensing volume. Table 6-1
Syringe specifications and functions
Specificati
Name
Function on
6-2
Fluidics
Low volume syringe
Aspirate and dispense blood sample of precise
Full range 250ul volume, and perform second aspiration Dispense fixed volume of diluent to the WBC and
High volume syringe
RBC bathes, dispense liquid to the probe wipes, and
Full range: 10ml supports the cleaning of the interior and exterior of sample probe as well as the baths.
6.1.4 Preheating bath Symbol
Preheating bath Appearance:
Function: dispense diluent and ensure the reaction temperature in the WBC bath.
6.1.5 Vacuum pump Symbol
6-3
Fluidics
Appearance:
Function: to empty probe wipes, WBC bath and RBC bath; empty the vacuum chamber and build vacuum pressure in the chamber
6.1.6 Air pump Symbol
Appearance:
6-4
Fluidics
Function: to provide pressure and generate bubbles
6.1.7 Sample probe Symbol
Appearance: N/A Function: provides a rigid, blood corrosion-resistant cavity for aspiration and dispensing of sample and probe cleanser.
6.1.8 Probe wipes Symbol:
6-5
Fluidics
Appearance:
Open-vial probe wipe Function: provide a cavity where the interior and exterior walls of open-vial probe or piercing probe can be cleaned by liquid flow; and the waste thus produced is also collected here.
6.1.9 Baths WBC bath: consists of front bath, back bath and an aperture. It is where the WBC sample is mixed for analysis; supports the measurement of HGB and WBC. RBC bath: consists of front bath, back bath and an aperture. It is where the RBC sample is mixed for analysis; supports the measurement of RBC/PLT. Vacuum chamber: where a stable vacuum is built and stored to support WBC and RBC count (impedance method); and the front and back baths as well as the sample probe wipe are cleaned. WBC isolation chamber: provides an air space to isolate exterior interference. RBC isolation chamber: provides an air space to isolate exterior interference.
6.1.10 Filters Isolation chamber filters: filter the impurities and debris from the WBC bath.
6-6
Fluidics
6.2 Sample Dilution Flow Chart 6.2.1 Whole Blood Mode Compared to old models, the analyzer adopts a "single aspiration" method for whole blood analysis. The basic procedure is as follows: 1) The sample probe aspirates 9uL of sample blood and ascends. In the meanwhile, the exterior wall of the sample probe is cleaned. 2) Dispense the initial volume and 9uL of sample to the WBC bath, where they are well mixed to prepare the diluted sample for WBC and HGB measurement. 3) The sample probe ascends. In the meanwhile, its exterior wall is cleaned. Where the sample probe ascends to the probe wipe, it dispenses some of the diluent in it to clean its interior wall. 4) The sample probe whirls descending to the RBC bath, and dispenses initial volume to the bath. 5) The sample probe whirls descending to the WBC to aspirate 23.1ul of diluted sample and then dispense the sample and additional diluent to the RBC bath. In the meanwhile, additional diluent is added to the RBC bath. The further diluted sample is used for RBC/PLT count. 6) Add and mix lyse to the WBC bath for reaction; 7) Run the analysis; 8) When the analysis completes, clean the WBC and RBC baths, zap the apertures, and release the vacuum pressure. The dilution procedure under whole blood mode is illustrated Figure 6- 1 as below:
6-7
Fluidics
Figure 6- 1 Dilution under whole blood mode
6.2.2 Predilute Mode The analysis under predilute mode contains 3 function-based sequences: diluent dispensing sequence, cleaning (open-vial) sequence and analysis sequence. The basic procedure is as follows: 1) Sample probe dispenses 700uL of diluent to the centrifugal tube. Then use a capillary tube to add the 20uL of sample blood to the centrifugal tube. Well mix the sample. 2) Sample probe aspirates and dispenses 198uL of the prepared sample to the WBC bath. Add diluent to the bath to fairly mix with the sample for WBC and HGB measurement. 3) Sample probe ascends. Its interior and exterior walls are cleaned. 4) The sample probe descends to the WBC to aspirate 37.7ul of diluted sample and then dispense the sample to the RBC bath. In the meanwhile, additional diluent is added to the RBC bath. The further diluted sample is used for RBC/PLT count. 5) Add and mix lyse to the WBC bath for reaction; 6) Run the analysis; 7) When the analysis completes, clean the WBC and RBC baths, zap the apertures, and release the vacuum pressure. You can see the analysis procedures under whole blood and predilute modes are basically the 6-8
Fluidics same except for the sample aspiration procedure and the sample dispensing procedure to WBC bath. The dilution procedure under predilute mode is illustrated Figure 6- 2 as below:
Figure 6- 2 Dilution under predilute mode
6.3 Introduction to Fluidic Channels 6.3.1 WBC/HGB channel Reagent used: 1) M-30PCFL cyanide-free lyse (break out RBCs and PLTs and 3-differentiate WBCs based on cell size); 2) M-30PD diluent (used for cleaning, and providing appropriate environment for reaction and measurement) Measurement principle: impedance method (for WBC count); colorimetric method (for HGB measurement) Measurement parameters: WBC and HGB Output graph: WBC histogram Dilution ratio: 1：305.2 (whole blood mode); 1：500.8 (predilute mode) Aperture diameter: 100um 6-9
Fluidics
Sample volume needed: 400μl; analysis time: 10s Function description: 9ul blood sample and 1.55ml diluent are mixed in the WBC bath to get diluted sample; of which 23.1ul is dispensed to the RBC bath, and mixed 0.31ul of lyse. The sample solution after full reaction is then sucked into the back bath by vacuum pressure in the vacuum chamber. The cells are counted when they pass the aperture. Sample volume is calculated based on analysis time.
6.3.2 RBC/PLT channel Reagent used: diluent (dilution, cleaning, providing conductive environment and processing cell sizes) Measurement principle: impedance method Measurement parameters: RBC and PLT Graphics: RBC histogram; PLT histogram Dilution ratio: 1：16497.3 (whole blood mode); 1：16445.7 (predilute mode) Aperture diameter: 70um Sample volume needed: about 200μl; analysis time: 10s Function description: sample probe aspirates 23.1ul of the diluted sample (dilution rate: 1：173.22) from the WBC bath, and dispenses the sample as well as additional diluent to the RBC bath, where the sample and the diluent are further mixed with existing initial volume of diluent (in all 2.2 ml diluent is used in this process) to get a dilution of 1：16497.3. After full mixing and reaction, the sample solution is then sucked into the back bath by vacuum pressure in the vacuum chamber. The cells are counted when they pass the aperture. Sample volume is calculated based on analysis time.
6.4 Sample Volume Table 6-2 Sample Volume Whole Blood Mode
Predilute mode Manual dilution: 20uL blood sample and 700uL diluent;
9µL aspirate 198µL
6.5 Temperature of Fluidics 6.5.1 Introduction to the Thermo System The thermo system of this analyzer refers to the diluent heating module, which ensures the best reaction temperature for the WBC bath. The diluent heating system consists of the diluent temperature detection unit and the preheating unit. The heating control of the heating units is detected and managed by the diluent temperature
6-10
Fluidics sensor and preheating sensor. The temperature ranges at various detection positions are as follows: Name Diluent detection unit temperature Preheating unit temperature
Temperature range (° °C) 10~40
Floating value, determined by diluent temperature. [Target temperature] -1.5, Target temperature +3]
6.5.2 Diluent Heating System
Diluent temperature detection unit structure
Symbol:
Appearance:
Function: a. check whether the diluent temperature fall in the range of [10°C，40°C]. When it is out of the range, the analyzer will stop working and gives out alarm; b. provide diluent temperature needed for the calculation of bath temperature.
6.6 Reagent Consumption Volume The analyzer supports both Whole Blood and Predilute modes. See Table 6-4 for the reagent consumption volumes for each single-sample analysis cycle, as well as the reagent volumes consumed in other major functions.
6-11
Fluidics Table 6-4 Sample
Presentation
Reagent Consumption Volume Probe Cleanser
Diluent (ml)
Lyse(ml)
Whole blood mode
19.96
0.31
0
Predilute mode
19.93
0.31
0
Dispensing diluent
1.4
0
0
Shutdown
36.1
0
1
44.04
0
0
Exit standby1
4.29
0
0
Exit standby2
33.28
0
0
Exit standby3
44.04
0
0
Exit standby4
44.35
0.31
0
Replace diluent
80.92
0
0
Replace lyse
25.55
7
0
Unclogging
14.98
0
0
Probe Cleanser maintenance
37.1
0
1
Overall cleaning
33.28
0
0
Mode
Startup
(exclude
consumption
(ml)
the during
background check)
6.7 Introduction to Sequences 6.7.1 Analysis Sequence under Whole Blood Mode This section introduces the sampling procedure, analysis procedure as well as the cleaning procedure.
6.7.1.1
Sampling Procedure
The sample probe workflow is shown in Figure 6- 3. See section 6.2 for the sample dilution procedure. The sample probe workflow can be divided into following steps:
a) Aspiration ① Aspirate 9ul of sample blood. b) First dilution ① Sample probe aspirates required volume of sample, and move from the tube; ② Sample probe move horizontally to the position above the WBC bath; ③ Sample probe descends to the WBC bath and dispenses 9ul of sample. c) Dispense initial volume to RBC bath ① Sample probe ascends from the WBC bath to the probe wipe where its interior and exterior walls are cleaned; ② Sample probe whirls descending to the RBC bath, and dispenses initial volume to the bath. d) Aspirate sample dilution from WBC bath ③
Sample probe ascends from the RBC bath and whirls to the position above WBC 6-12
Fluidics
bath; ④ Sample probe descends into the WBC bath and aspirate 23.1ul of sample after first dilution. e) Second dilution in RBC bath ① Sample probe aspirates required volume of sample, and move from the WBC bath; ② Sample probe move horizontally to the position above the RBC bath; ③ Sample probe descends into the RBC bath and dispenses the sample dilution. ④ Sample probe returns to its original position.
6-13
Fluidics Figure 6- 3 Sampling
6.7.1.2
Analysis Procedure
After the sample aspiration and dispensing procedure, the analysis will start. See Figure 6-4 for the procedure. Build in the vacuum chamber a -30KPa vacuum which presses the sample solution in the front baths of WBC and RBC baths to flow through the apertures to the back baths. The sample solution in both the two back baths will then flow to the vacuum chamber in the direction indicated by the red arrows.
Figure 6-4 Analysis Procedure
6.7.1.3
Cleaning Procedure
As the analyzer only has two baths, the cleaning procedure is comparably simple : 1. Empty and prime the WBC bath; 6-14
Fluidics 2. Zap apertures, clean the back baths; 3. Empty and prime the RBC bath; 4. Clean the back baths again; 5. Empty and prime the WBC bath.
6.7.2 Analysis Sequence under Predilute Mode Analysis sequence under predilute mode for a large part is the same as that of whole blood mode except for sample and the diluent consumption.
6.7.3 Introduction to Major Maintenance Sequences 6.7.3.1
Probe Cleanser Maintenance (Shutdown Sequence)
The probe cleanser maintenance during the shutdown process involves the following parts: the front and back baths of WBC and RBC baths, back bath tubing, sample probe as well as sampling tubing. The analyzer will perform "enhanced" probe cleanser maintenance after every 300 analyses. Compared with normal probe cleanser maintenance, the enhanced process uses a longer probe cleanser soak time (1 minute longer than normal maintenance). Tap "Fluidic" on the "Maintenance" screen, the analyzer will perform enhanced probe cleanser maintenance.
6.7.3.2
Cleaning Procedure during Startup
The fluidic actions during the startup consist of the following parts: 1 Initialization of fluidic components: initialize the aspiration module and syringe module, build and release vacuum. 2 Overall cleaning: clean all the tubes, parts and components of the analyzer. Remove bubbles in the diluent preheating bath. No lyse is consumed. 3 Background check: under whole blood mode. If the background does not pass, the analyzer will perform the overall cleaning procedure one more time, and then check the background again. When the analyzer starts after abnormal shutdown, it will perform the overall cleaning procedure twice.
6.7.3.3
Standby
The analyzer enters "Standby" mode when there is no action perform for 15~30 minutes
6-15
Fluidics (configurable, 15 minutes by default) When the analyzer is standby, you can still perform operations not involving fluidic actions. Exit standby status1: standby for less than 1 hour Clean the exterior wall of sample probe and WBC bath, re-build isolation bubbles. The process does not consume lyse. Exit standby status1: standby for more than 1 hour, but no longer than 3 hours. Clean both the exterior and interior walls of sample probe, clean the WBC and RBC baths, re-build isolation bubbles. The process does not consume lyse. Exit standby status3: standby for more than 3 hours, but no longer than 12 hours. Equivalent of overall cleaning; all the tubing, parts and components will be cleaned, remove bubbles in the diluent preheating bath, remove the crystallization and bubbles at the diluent inlet. Exit standby status4: standby for more than 12 hours. Base on Exit standby status3, increase to remove bubbles in lyse tubing.
6-16
7 Hardware System The hardware system not only consists of power board, main control board, indicator board, touch screen control board and liquid detection board, but also the electrified drives and components (e.g. motors, valves, pumps, sensors, screens, and power filters), as well as the cables connecting different boards or connecting boards and components.
7.1 Hardware System Function Block Diagram The function block diagram of the hardware system is shown as below.
The hardware system consists of 5 major modules: system power, data flow channel, main control system, drive parts and peripheral interfaces.
Figure 7-1 Function Block Diagram of the Hardware System The functions of each module are shown below: 1.
System power: provide power of required specifications to all boards, parts and devices
2.
Data flow channel: detect, condition, amplify, collect and pre-process signals.
3.
Main control system: collect and process data, display results and store sample information. Besides, main control system acts as the control and management center which controls and responds to all other components and devices.
4.
Drives/detectors: control valves, pumps and motors; monitor the photocouplers and other important parameters; collect information during analysis and send out flags.
5.
Peripheral interfaces: include interfaces to display/touch screen, USB ports (connecting to 7-1
Hardware System printer, keyboard, and barcode scanner) and Ethernet interface. Besides, peripheral interfaces also include those to the working status indicator and the [Aspirate] key.
7.2 Electrical Connection Diagram The electrical connection of the analyzer is shown as below:
Figure 7-2 Electrical Connection For a more detailed electrical connection diagram, please see Appendix C.
7.3 Main Control Board 7.3.1 Overview The main control board consists of analog module, digital module and power drive module; among which, the analog module conditions and amplifies the signals from the impedance channel and HGB channel as well as other analog signals like monitoring voltages, and converts them into digital signals through the A/D converter. The digital module is responsible for the drive and control 7-2
Hardware System of mechanical parts as well as the processing, outputting and communication of data. The power drive follows the instruction of CPU to drive the motors, valves, pumps and heaters. For troubleshooting information of the main control board, please refer to section 7.2.
7.3.2 Components The structure of the main control board is illustrated in figure 8-6. It mainly consists of digital circuits and several ADC circuits for A/D conversion. The digital circuit module is responsible for processing data, saving and outputting results. Furthermore, as the core of the main control board and even the whole hardware system, it takes the management and communication job. ADC circuits uses A/D converters to convert analog value monitoring signals (like WBC, RBC, PLT counts etc.) to digital signals. The control function of the main control board is realized with a "CPU+FPGA" structure. The main control board mainly provides the following functions: A/D conversion Data processing Peripheral interface enabling Control interface extending
Figure 7-3 Main control board structure Introduction Drive module Consists of motor drive and power component drive A/D conversion 7-3
Hardware System Converts analog signals to digital signals which can be processed by FPGA or CPU. Data processing FPGA filters the digital signals collected during A/D sampling and saves the particular parameters. It then transmits the data to CPU by various means (like interrupt control) for further processing. The processed data will be displayed on the LCD screen. Peripheral interface enabling CPU module acts as the platform for software operation . It also enables the peripheral interfaces like indicator board interface, LCD display interface, Ethernet interface, USB printer interface, and the ports to barcode scanner, keyboard and USB. Besides, it provides a JTAG interface for FPGA online programing, and a CPU debugging interface. Control interface extending Provide control logic and interfaces to the LCD screen, SD card, touch screen and recorder.
7-4
Hardware System
J7
J8
J9 J11 J10 J12 J13 J14 J15
J6
J16 J20 J19
J25 J24 J26 J5 J42
J27 J28
J41
J43
J29 J30
J4
Figure 7-4 Sockets on the main control board
Definition of sockets The main control board has 13 sockets. See Table 7-1 for the socket functions; see Figure 7-4 for their positions.
Table 7-1 Socket functions on the main control board 7-5
Hardware System Sockets J4
Function Socket
to
analog circuit
PIN function description PIN1: 12V
Description /
PIN2: 12V_N PIN4: AC120V_A PIN5: AC120V_B PIN3,PIN6: GND
J5
Socket
to
digital circuit J6
Socket
PIN1,2: 5V
/
PIN3,4: GND to
power circuit
PIN1,2: 24V
Control motors, valves, pumps,
PIN3,4: 12V
heaters and LCD backlight
PIN5~8: GND J7
Socket
to
/
/
to
/
/
Socket to valve
/
/
to
PIN1,3: 24V
/
to
/
/
sampling motor J8
Socket syringe motor
J9
and pump drive J11
Socket heaters
J12
Socket photocoupler signals
J14
Socket to liquid
PIN2: reagent detection
detection board
signals PIN5:
diluent
detection
signals PIN1,6: GND PIN3,4: 3.3V J15
Socket
to
[Aspirate] and
key waste
detection
PIN1:
[Aspirate]
key
/
signals PIN3: floater signals PIN2,4: GND
floater J16
Socket
to
/
/
to
/
/
Socket for LCD
/
/
/
/
printer interface J19
Socket keypad interface
J24
signal processing J25
Socket for LCD backlight control
7-6
Hardware System J26
Socket to touch
/
/
screen pinboard J27
J28
Socket
to
PIN1,3:
temperature
/
temperature
sensors
sensor
PIN2,4: GND
Socket to HGB
/
/
/
/
/
/
assembly J29
Socket for RBC signal processing
J30
Socket WBC
for signal
processing
7.3.3 Debugging and Troubleshooting All the configurable parameters on the main board can be adjusted to command. Adjust the parameters on the software screens. LED indicator functions The functions of the LED indicators on the main control board are defined in Table 7-2: Table 7-2 Functions of LED indicators on the main control board Indicators D1, D2
Possible causes when the LED does
Functions
not light
Network socket indicator: when
Network not connected, network
the network cable is properly
cable damaged, error with main control
connected to the PC, D2 lights on,
board
while D1 flickers D5~D12
USB indicators. D10 and D12 always on; D6~D9 respectively corresponds
to
the
4
Power board error, DC circuit cable error, and main control board error.
USB
interfaces and only lights on when a USB device is inserted. D13~D18
Motor indicator; flicker when a
Power error, main control board error
motor is moving D21
FPGA Operation indicator
CPU buckle plate error, SD card error, main control board error
D28
-5V power indicator
Power board error, DC circuit cable error, main control board short-circuited
D26
12V power indicator
Power board error, DC circuit cable error, main control board short-circuited
D27
24V power indicator
Power board error, DC circuit cable
7-7
Hardware System error, main control board short-circuited D28
-5V power indicator
Power board error, DC circuit cable error, main control board short-circuited
D30
-12V power indicator
Power board error, DC circuit cable error, main control board short-circuited
D31
12V power indicator
Power board error, DC circuit cable error, main control board short-circuited
Test points The functions of the test points on the main control board are listed in Table 7-3. Also refer to Figure 7-7 for positions and numbering of the test points.
If power errors are suspected, first pull out all other cables other than power cables to rule out the possibility of any short-circuited peripheral. Table 7-3 Functions of test points on the main control board No.
Test Points
1
TP3
Touch screen interrupt signal
/
2
TP4
Touch screen reset signal
/
3
TP5
Digital cable
/
4
TP7
Backlight enabling signal
5
TP8
Backlight signal
PWM
6
TP9
Backlight signal
GND
7
TP61
5V voltage monitoring point
Voltage is not 5V; main control board or power board error
8
TP69
VDD 3.3V voltage monitoring point
Voltage is not 3.3V; main control board or power board error
9
TP70
VDD18 1.8 V voltage monitoring point
Voltage is not 1.8V; main control board or power board error
10
TP71
VDD12 1.2 V voltage monitoring point
Voltage is not 1.2V; main control board or power board error
11
TP80
VDD25 2.5 V voltage monitoring point
Voltage is not 2.5V; main control board or power board error
12
TP84
Analog ground
13
TP87
12V voltage monitoring point
Introduction
ground
Troubleshooting
Voltage is 3.3V; main control board error Voltage is out of the range of 0.7V~1.2V; main control board error /
/ Voltage is not 12V; main control board or power board error (ground for the voltage is not GND, but J68_PIN2)
7-8
Hardware System 14
TP108
ADC U29 5.0V reference voltage
Voltage is not 5.0V; main control board error
15
TP109
ADC U30 5.0V reference voltage
Voltage is not 5.0V; main control board error
16
TP110
ADC U28 2.5V reference voltage
Voltage is not 2.5V; main control board error
7.4 Power board 7.4.1 Overview The power board provides the analyzer with 6 units of reliable power output, including D5V, A+12V, A-12V, AC120V. P24V and P12V.
Definition of interfaces There are 6 interfaces to external systems on the power board; among which J1 to J4 are sockets, L and N are AC input connecting cables, wiring from the side of the board to the sockets; the inverter mini-board is directly inserted to the main board through a socket. The interface positions on the power board are illustrated as below:
A small inverter board Figure 7-5 Interface connections on the power board The functions of the interfaces are listed below: Table 7-4 AC input connection cable PIN
Definition L
Live line terminal to AC
N
Zero line terminal to AC
7-9
Hardware System Table 7-5 Outlet sockets Name
Socket No.
D5V
Description PIN1: GND
J1 PIN2, PIN3: 5V P12V, P24V
PIN1: GND J2
PIN2: 12V PIN3: 24V
A+12V, A-12V
PIN1, PIN4: GND J3
PIN2, PIN3, PIN5: -12V PIN6: 12V
AC120V
J4
AC
7.4.2 Power Board Replacing and Wiring The power board plays a very important part in the device, and any error with the board may endanger the operation of the whole. Follow below steps to replace the power board when needed: Tools: 107 cross-headed screwdriver, multimeter. Disassembly: 1. Shut down the analyzer and pull out the AC cables; 2. Take out the power assembly from the main unit case; 3. Open the power unit, remove the 4 fixing screws on the power board, and take out the board from the power unit.
WARNING Wear an antistatic wrist strap while removing the board; Always shut down the power and pull out the power cable before removing the board. Installation: Install the power board in the reversed order of the disassembly steps. Check: 1. Check whether all the screws on the board are properly fixed; 2. Connect the power cable, and turn on the AC switch. The analyzer starts its initialization, and all the indicators on the board light on.
7-10
Hardware System
CAUTION Ensure the power unit is tightly fixed to the main unit case with screws. Before disassemble the power board, ensure the power board and its peripherals have cooled off.
7.5 Touch Screen Control Board 7.5.1 Introduction As the interface between the touch screen and the main control board, the touch screen control board transfers the touch actions from the users to recognizable signals by main control board. You may need to make some adjustment to the touch screen control board during use.
7.5.2 Components With the 4-wire touch screen controller chip TSC2004IRTJR as its core chip, the board communicates with the main control board about touch point positions through an I2C interface.
Figure 7-6 Connection of touch screen
7.6 Indicator Board 7.6.1 Introduction The indicator board informs about the working status of the analyzer by sending out sounds and lights.
7-11
Hardware System Figure 7-7 Indicator board
7.6.2 Components The indicator board consists of a three color indicator (red, yellow and green) with its control circuit as well as the buzzer drive circuit. You do not need to make adjustment to the indicator board during use.
7.7 Motors, Photocouplers and Micro-switches 7.7.1 Introduction Motors drive the aspiration module and syringe module etc.; photocouplers detect the motor movements; and micro-switches are used to start analysis process. See below for the illustrations of motors and photocouplers.
7.8 Liquid Detection Board 7.8.1 Introduction The liquid detection board detects whether there is liquid in the tubes by monitoring the index of refraction. 7-12
Hardware System
Figure 7-8 Liquid detection board
7.8.2 Components The most important components of the board are the photocouplers. There is an LED indicator on the back of the board, which will light off when the photocoupler is blocked between its transmitting and receiving tubes, and light on when the photocoupler is blocked. You can use a piece of paper to block the photocoupler and check whether the board is working properly.
7.9 Hardware Troubleshooting 7.9.1 System Error Hardware system errors mainly include board errors, cable errors and component errors. The subsequent sections should have provided troubleshooting methods for most of such errors; but when the power supply to the hardware system is abnormal (for example, the analyzer cannot be powered on, or would start self-protect mechanism immediately after being powered on), you need to start troubleshooting from the system level. Figure 7- 9 demonstrates the troubleshooting procedure for power supply errors. Figure 7-10 displays a filter locating at the lower part at the rear of the analyzer. The filter controls the power supply and frequency filtering of the analyzer.
7-13
Hardware System
Figure 7-9 Troubleshooting for power supply errors
Figure 7-10 Filter Figure 7-11 shows the troubleshooting flowchart for power-on protection.
7-14
Hardware System
Figure 7-11 Troubleshooting for power-on protection errors
7.9.2 Troubleshooting for Main Control Board Table 7-4 lists the errors commonly found on the main control board as well as their solutions. However, the list only includes hardware errors and sometimes software errors may cause similar problem. Also many errors need to be detected by software. Check the following items before troubleshooting the main control board: 1.
Check whether the cables connecting to the main control board get loose or insecure.
2.
Check whether the position no. marked on the cable correspond to the sockets there are connected to; and whether the cables are broken or damaged;
3.
Check whether the input power of sockets J4~J6 on the board are normal (measure the voltages with a multimeter; refer to "Definition of sockets" for the pin functions).
4.
Check whether the indicators on the main control board work properly against Table 7-2. When you have confirmed all the cables are properly connected, all the input power and
indicators work normally, follow the instruction in Table 7-6 for troubleshooting. Table 7-6 Troubleshooting for main control board No. 1
Error LCD
Troubleshooting
Solution
1. Check whether the cable connecting the
Unplug
7-15
and
Hardware System screen
main control board and the backlight socket, and
reconnect the cable
becomes
the cable connecting the main control board and
connecting the main
black.
the LCD screen are properly connected. Unplug
control board and
and then reconnect such cables. Power on the
the backlight and the
analyzer again and see whether the error is
cable connecting the
removed. If not, proceed to next step.
main control board and the LCD screen.
2. Replace the cable connecting the main
Replace
the
control board and the backlight and the cable
cable connecting the
connecting the main control board and the LCD
main control board
screen. If the error still exists, proceed to next
and
step.
and
the
backlight
the
cable
connecting the main control board and the LCD screen. 3. Use a multimeter to measure the voltage between PIN1 and PIN3 of J25, when the result
Replace
the
main control board
is not within the range of 10.5~13.5, then the power supply to backlight is with error. If not the case, proceed to next step. 4. Use a multimeter to measure the voltage between TP8 and TP9, when the result is not within the range of 0.7~1.1V, then there is backlight brightness control error. If not the case, proceed to next step. 5. Use a multimeter to measure the voltage between TP7 and TP9, when the result is not within the range of 3.10~3.50V, then there is backlight enabling error. If not the case, proceed to next step. 6. Replace the LCD screen. If the error remains, proceed to next step. 2
LCD
1. Reconnect the cable connecting the main
Replace
the
LCD screen Unplug
and
display
control board and the backlight socket, and the
reconnect the cable
flickers
cable connecting the main control board and the
connecting the main
7-16
Hardware System LCD screen. Power on the analyzer again and
control board and
see whether the error is removed. If not, proceed
the backlight and the
to next step.
cable connecting the main control board and the LCD screen.
2. Replace the cable connecting the main
Replace
the
control board and the backlight and the cable
cable connecting the
connecting the main control board and the LCD
main control board
screen. If the error still exists, proceed to next
and
step.
and
the
backlight
the
cable
connecting the main control board and the LCD screen. 3. Replace the main control board. If the error is removed, then the problem is caused by
Replace
the
main control board
differential conversion chip (U10) or board AM1808 failure. If not, proceed to next step. 4.
Replace
the
LCD
screen
(screen
assembly). If the error is removed, then the
Replace
the
screen assembly
problem was caused by LCD assembly failure. 3
LCD
1. Reconnect the cable connecting the main
Reconnect
the
displays
control board and the LCD screen. Power on the
cable connecting the
strange
analyzer again and see whether the error is
main control board
patterns
removed. If not, proceed to next step.
and the LCD screen.
2. Replace the cable connecting the main
Replace
the
control board and the LCD screen. If the error
cable connecting the
still exists, proceed to next step.
main control board and the LCD screen.
4. Replace the main control board. If the error remains, proceed to next step. 5.
Replace
the
LCD
screen
Replace
the
main control board (screen
assembly). If the error is removed, then the
Replace
the
screen assembly
problem was caused by LCD assembly failure. 4
Bad network
1. Check whether the IP of the PC falls in the same network segment of the main control
7-17
Set the IP of the PC to 10.0.0.3.
Hardware System connection
board IP (10.0.0.X). When it is not, reset the IP of the PC to 10.0.0.3, and see whether the network connection is OK. If the network connection still fails, proceed to next step. 2. When the analyzer is powered on and
Reconnect
or
connected to PC, but D1 and D2 do not light on,
replace the network
then the network connection is bad or the
cable.
network cable is damaged. If not the case, proceed to next step. 3. D1 and D2 off, but network connection is OK. 5
USB
Replace
the
main control board 1. If D10 and D12 do not light on when the
ports fail to
analyzer is powered on, then the USB HUB chip
response.
(U1) is with error. If not the case, proceed to next
Replace
the
main control board
step 2. If D10 and D12 do light on when the
Replace
the
analyzer is powered on, replace the peripherals
devices connecting
connected to the USB ports (mouse, keyboard or
to the USB ports.
USB disk etc.). If the peripherals still cannot be used, proceed to next step. 3. If the error still remains after all above steps, replace the main control board. 6
Clock time
1. Power off the analyzer, and use a
resets
multimeter to measure the voltage between the
every time
two ends of the button cell B1. When the
after
measured voltage is "Sample Probe Debug". Go to the screen shown in Figure 2.1. Tap "Height-fixed pos.";
2.2
Loosen the 2 screws shown in Figure 2.2, and then take the sample probe out of the probe wipe;
Figure 2.3
2.3
2.4
Point of Control
Criteria of Control
Place the positioner around the probe wipe as shown in Figure 2.3, and then put the sample probe into the wipe. Secure the 2 screws shown in Figure 2.2;
Insert the sample probe in the wipe until it reaches the end position;
1、 Secure screws;
Tap "Initial position", and then tap any of following buttons: "WBC Bath", "Aspiration pos.", and "RBC Bath". Check whether there is interference between the sample probe and other components.
Adjust the position of the sample probe.
There should be no interference between the sample probe and other components.
Watch through this hole to see whether the bottom of the sample probe contacts the positioner
10-3
the
Adjustment
10.3 Adjusting Analysis Components 10.3.1 Preheating Temperature Calibration and Validation Figure 3.1`
Value measured by the instrument
Enter the sum of the measured value and the value in FRU
Step
Action
3.1
Tap MENU>"Service">"Temperature calibration" to go to the temperature calibration screen. Tap the "Preheat bath temperature" to go to the screen shown in Figure 3.1;
3.2
Record the "Machine measurement value", and enter the sum of this value and the value in service FRU in the "Meter measurement value" field.
10-4
Point of Control
Test for the calibration factor of the preheat bath temperature
Criteria of Control
Adjustment
10.3.2 Counting Channel Test Figure 4.1
Step
Action
4.1
Open the shielding box of the counting bath, and run blank counts for several times in whole blood mode;
4.2
Observe the whole counting process, and make sure there is no gas column in the aspiration tubing and no liquid suspended at the sample probe. Otherwise, replace the tubing. Check and make sure that there is no gas column in the sample preparation tubing, and tubes of the WBC bath and RBC bath are fulfilled with liquid without any bubble.
10-5
Point of Control
Aspiration tubing, sample probe, counting bath
Criteria of Control
No gas column in the aspiration tubing and sample preparation, no liquid suspended at the sample probe, related tubes fulfilled with liquid without gas column.
Adjustment
Observe the whole counting process, and check whether the liquid level is normal after dispensing liquid in WBC/RBC bath; whether the sample probe tip is immersed in the liquid when the probe gets into the bath, whether there are splashes while dispensing liquid, and whether there are bubbles when making bubbles; whether bubbles come into contact with the liquid dispensing tube; whether the WBC bath and RBC bath can be emptied normally.
WBC bath, RBC bath
No splashes when dispensing liquid in WBC/RBC bath; bubbles can be made effectively; bubbles does not come into contact with the liquid dispensing tube; sample probe tip is immersed in the liquid; WBC and RBC baths can be emptied normally, no liquid reside on the wall of the bath;
Aperture voltage
4.4
Tap "Service">"Self-Test" to go to the self-test screen shown in Figure 4.1. Tap "Aperture voltage RBC" and "Aperture voltage WBC".
Aperture voltage normal; no error message.
4.5
Install the shielding box of the bath and fix it with M3X8 screws. Secure the screws using a cross-head screwdriver.
Secure screws.
4.6
Start the count again. Observe the sample probe action in the whole process. There should be no interference between the sample probe and the shielding box while mixing the liquid in the bath.
Sample probe position in relation to the bath shielding box position
4.3
the
Sample probe position in relation to the bath shielding box position
Note: the gas column mentioned above is a large bubble that divides the liquid into segments in the tubing.
10-6
11 Debugging and Validation After Servicing Component Name Master Board PCBA
Service Material ID 051-001714-00
Adjustment Requirement 1.
Back
configuration
Validation
up
the
data
as
Version information correct
instructed by the prompt on the screen; 2.
Check
the
version
information at the "Version Info" screen.
Syringe assembly
transfer
10ml Syringe
115-020624-00
Calibrate again
Check the repeatability
1. Make sure that there is
Check the repeatability
801-3003-00027 -00
Optical Sensor block of injector
3101-20-68304
special bolt 3
041-005167-00
250ul syringe (with nozzle)
115-027479-00
Sampling Assembly
115-025638-00
no bent-over of tubes, and no interference between the
Rotation Motor Pos Sensor Assy
801-3003-00015
tubes and the front plate,
-00
fluidic component partition, right door, motors, valves,
Sensor Package
801-3001-00055 -00
wire
harness
retainers
when the aspiration module is
moving
vertically
or
horizontally;
Sample Probe Wipe Block
801-1805-00004 -00
2. Make sure that the tubes are not deformed when passing through the wire harness retainers;
Sample probe
801-1805-00003 -00
3. Make sure that the inlet and outlet tubes of the probe wipe are not bent over
and
interference
there
is
when
no the
aspiration module is moving vertically or horizontally; 11-1
Debugging and Validation After Servicing 4. Adjust the mechanical position
of
the
sample
probe in relation to the WBC\RBC bath; 5. Calibrate again.
RBC bath
115-025644-00
1. Adjust the mechanical position
of
the
Check the repeatability
sample
probe in relation to the bath; 2. The waste tube of the bath need to be wound one lap in the vertical direction, the height of the twined tube should be higher than that of 3ml liquid; 3. Perform gain calibration; 4. Calibrate again.
WBC reaction bath assembly
115-025645-00
1. Adjust the mechanical position
of
the
sample
probe in relation to the bath;
1. Check the repeatability; 2. Make sure the HGB blank voltage is 4.2V.
2. The waste tube of the bath need to be wound one lap in the vertical direction, the height of the twined tube should be higher than that of 3ml liquid; 3. Perform gain calibration; 4. Calibrate again.
Shielding bottom plate welding piece
042-011786-00
Adjust
the
mechanical
position of the RBC bath
Make
sure
that
the
aspiration module does not come into contact with the RBC bath when it moves up and down above the RBC bath
HGB assembly
115-025640-00
Perform calibration
Vaccum/Pressure Chamber
115-025641-00
Waste assembly
pump
115-025643-00
2-way (Mindray)
Valve
3-way (Mindray)
Valve
/
HGB
gain
Make sure the HGB blank voltage is 4.2V. Make sure that bath can be emptied
normally,
and
vacuum can be built up normally.
801-3201-00002
/
1. Make sure the inlet and
-00
outlet
are
801-3201-00003
directions;
in
correct
2. The rubber tube should
-00
be inserted to the bottom; 11-2
Debugging and Validation After Servicing 3. If
a
wide
50 tube
connected to a valve or connector
is
unplugged,
discard it and use a new one for reconnection.
SMC hydraulic (3106)
3-way valve
115-015967-00
/
1. Make sure that the connections to N.C, N.O, and public ends are correct; 2. The rubber tube should be inserted to the end; 3. If
a
wide
50 tube
connected to a valve or connector
is
unplugged,
discard it and use a new one for reconnection.
Panel (BC-30S)
assembly
043-005464-00
Make sure that the touch screen works properly
10 Inch Touch Screen Long Gasket
047-005527-00
10 Inch Touch Screen Short Gasket
047-005528-00
Panel (BC-20S)
Perform screen calibration
assembly
043-005463-00
Long Gasket, IPM8 Touch Screen
047-005535-00
Short Gasket, IPM8 Touch Screen
047-005536-00
Touch 10.4″,
screen,
Touch resistive 4-wires
panel 8.4inch
021-000073-00
LCD (10.4″)
assembly
115-025652-00
LCD
assembly
115-025651-00
(8.4″) Diluent Pre-heating assembly
115-025649-00
801-3110-00184 -00
1.
The
J9
and
3-way
Make
sure
that
the
connector C10 must be
temperature values are in
inserted to the end;
specified
2. Enter the parameters recorded by FRU in the temperature screen
to
calibration attain
temperature values. 11-3
new
ranges
status screen
at
the
Debugging and Validation After Servicing
Lithium battery 3V 35mAh D12.5*2.0
SD card 8GB Class10
M05-010R03---
023-001056-00
Set time and date at the
The date displayed after
Date/Time Setup screen.
restarting the analyzer is
Save the setting and shut
the same as that before the
down the analyzer.
shutdown.
1. Back up the data before replacing the SD card (if possible); 2.
Restore
configuration data.
11-4
the
/
12 Service BOM ID
Name
115-025638-00
Sampling Assembly
801-1805-00003-00
Sample Probe
801-1805-00004-00
Sample Probe Wipe Block
801-3003-00015-00
Rotation Motor Pos Sensor Assy
801-3001-00055-00
Sensor Package
115-025639-00
Syringe assembly
801-3003-00027-00
10ml Syringe
115-027479-00
250ul Syringe(with nozzle)
115-025641-00
Vaccum/Pressure Chamber
115-025642-00
Reagent Detector Assembly
051-001621-00
Liquid Detect Board PCBA
043-000829-00
Reagent detection tube
115-025643-00
Waste pump assembly
115-025649-00
Diluent pre-heating assembly
115-025715-00
Air pump assembly
801-3201-00003-00
3-way Valve (Mindray)
115-015967-00
SMC 3-way hydraulic valve (3106)
801-3201-00002-00
2-way Valve (Mindray)
115-025644-00
RBC bath assembly
115-025645-00
WBC bath assembly
115-025640-00
HGB module
043-000711-00
Filter
801-1805-00023-00
Isolation chamber
042-011528-00
Shielding box
115-025646-00
Power box assembly
051-001714-00
Master Board PCBA
042-005949-00
Bottom signal shield
042-005948-00
Top signal shield
042-011531-00
Key mounting plate
115-025647-00
[Aspirate] key assembly
801-3007-00014-00
3007 Switch(FRU)
115-025648-00
Left Door Assembly
042-011533-00
Right door
042-011538-00
Top cover
M05-010R03---
Lithium battery 3V 35mAh D12.5*2.0
023-001056-00
SD card 8GB Class10
801-2800-00016-00
Recorder Module
115-015677-00
Diluent temperature detecting asm
Service BOM
115-028170-00
Tube package
115-025653-00
Front cover assembly (8.4″)
115-025651-00
LCD assembly(8.4")
047-005535-00
Long Gasket, IPM8 Touchscreen
047-005536-00
Short Gasket, IPM8 Touchscreen
021-000073-00
Touch panel resistive 8.4inch 4-wires
051-001857-00
3008 indicator board PCBA
043-005463-00
Panel assembled(BC-20S)
043-005810-00
[Aspirate] key(BC-20S)
115-025654-00
Front cover assembly (10.4″)
047-016362-00
10Inch Touchscreen Long Gasket
047-016363-00
10Inch Touchscreen Short Gasket
801-3110-00184-00
Touch screen, 10.4″
115-025652-00
LCD assembly(10.4")
043-005464-00
Panel assembled(BC-30S)
043-005353-00
[Aspirate] key
023-000866-00
Handheld Barcode Scanner
801-3007-00029-00
3007 CAP Component for LYSE(FRU)
115-013091-00
Waste capsule assembly
801-2800-00018-00
CAP Component for Diluent
801-3110-00167-00
Support panel for diluent bottle
115-030832-00
SD card
041-020880-00
Swab adjuster
12-2
13 Appendices A.
Fluidic diagram
Reagent Detection C23 T7
T54
J11
T47 T11
SV07
T23
T13
C4
T6
T8
C5
SV05
RBC
WBC
C22
Isolation Chamber 2
T37 SPB
T38
T20
T3
T36
T51
SV02
C3
C7
Isolation Chamber 1
C19 C1
C6
T25
T18
T35
J3-T34-J4
C20 J9-T52-J10
T4
T10
T14
SV04
SV09
SV08
T12
T43
Temperature sensor
T40
T17
C16
T26
SV06 C15
T2
T42
T29
C24
J7-T45-J8
T55
T1
T15
T28
C11
C12 C21
T53
VC
T46
T22 SV03
SV01
C9 T27
C8
J5-T44-J6
C10
T39 T41
T9
T21
T16
C17
WASTE SR
Waste Container
A-1
C18
LP
C17 T31
T30
T50
C18
Diluent Container
Transducer
T32
C13 C14 T49 T49
Lyse Container
Preheating bath
J1-T33-J2
T48
T19
T5
T24
C2
GP
B.
Connection and Tube
Information of Materials in the Fluidic Diagram Name in the Location in No. Material Type Material ID Unit Diagram the Diagram 1 Syringe SR 115-015652-00 D3 EA 2 WBC bath WBC 115-025645-00 A4 EA 3 RBC bath RBC 115-025644-00 A5 EA 4 Vacuum chamber VC 115-015673-00 C5 EA 5 Liquid pump LP 3001-10-07252 D4 EA 6 Gas pump GP 082-000221-00 D5 EA 7 Sample probe SPB 3001-10-07059 B3 EA 8 Probe wipe Probe wipe 3001-30-06957 C3 EA Isolation 9 Isolation chamber 115-002439-00 B4 EA chamber 1 Isolation 10 Isolation chamber 3003-20-34949 B5 EA chamber 2 11 Heating bath Preheating bath 115-009948-00 B2 EA Temperature 12 Sensor 115-015677-00 A2 EA sensor Electromagnetic 13 SV1 115-010088-00 C2 EA valve Electromagnetic 14
15 16 17 18 19 20 21
25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
valve Electromagnetic valve Electromagnetic valve Electromagnetic valve Electromagnetic valve Electromagnetic valve Electromagnetic valve Electromagnetic valve Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube
Quantity 1 1 1 1 1 1 1 1 1 1 1 1 1
SV2
115-015967-00
B3
EA
1
SV3
115-010089-00
C4
EA
1
SV4
115-010089-00
B4
EA
1
SV5
115-010088-00
A3
EA
1
SV6
115-010088-00
B2
EA
1
SV7
115-010088-00
A2
EA
1
SV8
115-010088-00
B5
EA
1
SV9
115-010088-00
B4
EA
1
T1 T2 T3 T4 T5 T6 T7 T8 T9 T10 T11 T12 T13 T14 T15 T16
082-000108-00 082-000108-00 082-000108-00 M90-000025--M90-000025--3001-10-07069 3001-10-07069 3001-10-07069 082-000108-00 M6G-020055--082-000108-00 082-000108-00 082-000108-00 M6G-020055--M6G-020054--082-000108-00
C2 C2 B2 B2 B2 A2 A3 A4 C2 B2 A2 C2 A2 B2 C2 C3
mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm
240 210 270 20 20 250 60 60 50 1200 50 20 20 270 1500 440
B-1
Appendices
41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95
Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Rubber tube Transfer tube Transfer tube Transfer tube Transfer tube Transfer tube Transfer tube Transfer tube Transfer tube Transfer tube Transfer tube Transfer tube Tube connector Tube connector Tube connector Tube connector Tube connector
T17 T18 T19 T20 T21 T22 T23 T24 T25 T26 T27 T28 T29 T30 T31 T32 T33 T34 T35 T36 T37 T38 T39 T40 T41 T42 T43 T44 T45 T46 T47 T48 T49 T50 T51 T52 T53 T54 T55 J1 J2 J3 J4 J5 J6 J7 J8 J9 J10 J11 C1 C2 C3 C4 C5
082-000108-00 M6G-020007--3001-10-07069 3001-10-07069 3001-10-07069 M90-100071--3001-10-07069 3001-10-07069 3001-10-07069 3001-10-07069 M90-000025--M90-000025--M90-100071--M90-000025--M90-000025--M6G-020055--M90-100031--M90-100031--M6G-020006--M6G-020006--M90-100071--M90-100071--M90-100071--M90-100071--M90-100071--M90-100071--M90-100071--M90-000026--M90-000026--M6G-020006--M6G-020056--3001-10-07069 A21-000002--A21-000002--3001-10-07069 M90-100031--3001-10-07069 M6G-020056--M90-100071--M90-100071--M6G-020006--M90-100071--M6G-020006--0030-20-13339 0030-20-13339 0030-20-13339 0030-20-13339 082-000055-00 082-000055-00 082-000055-00 M90-100066--M90-100027--M90-100027--M90-100066--M90-100027--B-2
C3 B3 B3 B3 C4 C4 A3 B4 B4 B4 C4 C5 C5 D5 D4 D4 B4 B5 B4 B5 B4 B5 C4 C5 C5 C5 C5 C5 C5 C5 A2 A2 B1 D2 B3 B3 C5 A1 C5 B4 B4 B5 B5 C5 C5 C5 C5 B3 B3 A2 B2 A2 C2 A2 B2
mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm EA EA EA EA mm mm mm EA EA EA EA EA
230 580 300 465 235 390 310 180 330 320 20 60 300 120 100 1500 160 160 20 20 210 220 70 30 130 140 90 300 300 80 420 300 180 300 80 260 40 600 45 25 25 25 25 1 1 1 1 20 20 20 1 1 1 1 1
Appendices
96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114
Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector Tube connector
C6 C7 C8 C9 C10 C11 C12 C13 C14 C15 C16 C17 C18 C19 C20 C21 C22 C23 C24
M90-100026--M90-100026--M90-100027--M90-100028--M90-100028-01 M90-100028-01 M90-100028-03 M90-100024--M90-100009--M6Q-030111--M90-100009--M6Q-030111--M90-100009--M90-100027-00 M90-100027-00 M90-100028-01 043-000892-00 043-000892-00 M90-100100---
B-3
B4 B5 C4 C5 C5 C5 C5 B1 B1 C2 C2 D2 D2 B3 B3 C5 A1 A2 C5
EA EA EA EA EA EA EA EA EA EA EA EA EA EA EA EA EA EA EA
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
C.
Hardware block diagram
C-1
D.
Cables and Wires
Material ID 009-002857-00
Name Heater connecting wire
009-002858-00
Temperature sensor connecting wire Indicator board connecting wire Analog board supervisory signal wire Optical signal output wire Analog main control board SPI signal wire Optical control signal wire Syringe motor connecting wire Digital power connecting wire Analog power connecting wire Sampling motor connecting wire Electromagnetic metering pump connecting wire Valve connecting wire Waste pump connecting wire Float switch connecting wire Sampling photocoupler connecting wire Touchscreen control cable
009-002863-00 009-002865-00 009-002866-00 009-002867-00 009-002869-00 009-002870-00 009-002871-00 009-002872-00 009-002875-00 009-002877-00 009-002878-00 009-002880-00 009-002881-00 009-002882-00 009-002911-00 009-002913-00 009-002967-00 009-002988-00 009-002989-00 009-003176-00
009-003322-00 009-003381-00 009-003642-00 2800-20-28762 009-004057-00
LCD signal wire RBC connecting wire Safety ground Component ground Syringe assembly photocoupler connecting wire Start key connecting wire Fan adapter cable Hydraulic sensor adapter cable HGB connecting wire LH&DIFF detect board wire
Connection Connects A-J21 with heater and temperature switch Connects A-J10 with temperature sensor Connects B-J78 with indicator board Connects A-J2 and B-J86 Connects A-J4 and B-J85 Connects A-J31 and B-J81 Connects A-J3 and B-J77 Connects A-J32 and syringe motor Connects C-J1/C-J2 and A-J22/B-J68 Connects A-J8 and C-J3 C-J4 Connects A-J24 and sampling motor Connects A-J16 and electromagnetic metering pump Connects A-J14 A-J15 and valves Connects A-J20 and waste pump Connects A-J1 and float switch Connects A-J12 and sampling photocoupler Connects B-J67 and touchscreen drive board Connects B-J4/B-J16 and LCD/backlight Connects A-J6 and RBC bath / / Connects A-J13 and syringe assembly photocoupler Connects B-J99 and start key Connects A-J17 A-J18 and fan Connects A-J11 and hydraulic sensor
Connects A-J5 and HGB bath Connects A-J26 and Liquid detect board PCBA Note: A refers to the analog drive board, B refers to the main control board, and C refers to the power board
D-1
Appendices
E. Level 1
Level 2
Menu Tree
Level 3
Access Level Operator Administrator √ √
Service √
Sample Analysis
/
/
Table Review
/
/
√
√
√
Setup
√
√
√
L-J QC
Count
√
√
√
Setup
√
√
√
Graph
√
√
√
Manual
/
×
√
√
Calibrator
/
×
√
√
Fresh blood
/
×
√
√
Background
/
×
√
√
Reproducibility
/
×
×
√
/
×
×
√
Date/Time Setup
√
√
√
Print setup
√
√
√
Communication
√
√
√
Shortcut Code Setup
√
√
√
Lab Info Setup
×
√
√
/
×
√
√
/
√
√
√
Reference Unit Setup
×
√
√
Reference Range Setup
×
√
√
/
×
√
√
Reagent Setup
/
√
√
√
Gain Setup
/
×
√
√
QC X-B QC
Calibration
Performance
Carryover
System Setup
Setup
Access Management Auxiliary Setup Setting Parameters Maintenance
Service
Status
Maintenance
/
√
√
√
Self-Test Sample Probe Debug Gain Calibration Temperature calibration Screen Cal. Advanced Toolbox Log
/
√
√
√
/
×
√
√
/
×
√
√
/
×
√
√
/
√
√
√
/
×
√
√
/
√
√
√
/
√
√
√
/
√
√
√
/
√
√
√
/
√
√
√
Counter Temp Pressure Voltage Sensor Version Info
Logout Shutdown
/ /
&
View
√
√
√
Upgrade
×
√
√
/
√
√
√
/
√
√
√
"√" indicates that this menu item is available at the access level; "× ×" indicates that this menu item is not available at the access level.
E-3
F. Product Model Inspection No. Item
Appendix Table SN
Description
Requirement
1
Electrical connections
Safe and earthing
2
Beeping alarm
/
3
Time and date
Time and date
4
Version
Version configuration information
5
Mechanical position validation
Sample probe position in relation to the WBC bath
6
Mechanical position validation
Sample probe position in relation to the RBC bath
Counting 7
Channel Test
reliable
Result
Conclusion
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
No bubble
□OK □NG
□PASS □FAIL
No suspended liquid
□OK □NG
□PASS □FAIL
Sample probe lower position normal
□OK □NG
□PASS □FAIL
There are bubbles when making bubbles
□OK □NG
□PASS □FAIL
There are bubbles when making bubbles
□OK □NG
□PASS □FAIL
No overflow or contact
□OK □NG
□PASS □FAIL
No overflow or contact
□OK □NG
□PASS □FAIL
See the diagrams in the appendices Having beeping alarm Correct time and date
and
Whether there is bubble in the aspiration tubing Whether there is liquid suspended at the sample probe tip Sample probe is under the surface of the liquid and does not contact the bottom of the bath Whether there are bubbles when making bubbles in the WBC bath Whether there are bubbles when making bubbles in the RBC bath In the process of making bubbles in the WBC bath, whether there is overflow, and whether the bubbles contact the inlet tube In the process of making bubbles in the RBC bath, whether there is
Correct version See the section of "Adjusting Mechanical Positions" See the section of "Adjusting Mechanical Positions"
F-1
Connection and Tube
overflow, and whether the bubbles contact the inlet tube Whether the WBC bath is emptied normally Whether the RBC bath is emptied normally Bath shielding box installation
8
9
Instrument maintenance
Background test
Emptied normally
□OK □NG
□PASS □FAIL
Emptied normally
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
Screws are well fixed No interference Sample probe action when the sample probe is in action No interference between the probe Sample probe tubing sample tubing and other structures Perform Refer to the maintenance and operator's cleaning manual WBC ≤0.2×109/L
□PASS □FAIL
12
RBC
≤0.02×10 /L
□PASS □FAIL
HGB
≤1g/L
□PASS □FAIL
HCT
≤0.5%
□PASS □FAIL 9
PLT 10
Recorder
Print analysis results
11
Shutdown
Shutdown process
≤5×10 /L Able to print properly No error message or alarm
Tested by:
Date:
F-2
□PASS □FAIL □OK □NG
□PASS □FAIL
□OK □NG
□PASS □FAIL
P/N: 046-007130-00(3.0)
