BC-3600 BC-3300
Auto Hematology Analyzer
Service Manual
Copyright © 2008-2011 Shenzhen Mindray Bio-medical Electronics Co., Ltd.
All rights Reserved.
For this Service Manual, the issued Date is 2011-02 (Version: 1.0).
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 copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties. 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, rent, adaptation and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
.
,
are the registered trademarks or trademarks owned by
Mindray in China and other countries.
All other trademarks that appear in this manual are
used only for editorial purposes without the intention of improperly using them. 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 safety, reliability and performance of this product only in the condition that:
all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national
I
and local requirements;
the product is used in accordance with the instructions for use.
This equipment must be operated by skilled/trained medical professionals.
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.
II
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:
any Mindray product which has been subjected to misuse, negligence or accident;
any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed;
any product of any other manufacturer.
Safety, Reliability and Performance Mindray is not responsible for the effects on safety, reliability and performance of BC-2800Vet, if:
Assembly operations, extensions, re-adjusts, modifications or repairs are carried out by persons other than those authorized by Mindray.
Personnel unauthorized by Mindray repairs or modifies the instrument.
Return Policy Return Procedure In the event that it becomes necessary to return this product or part of this product to Mindray, the following procedure should be followed:
1.
Obtain return authorization: Contact the Mindray Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Returned shipments will not be accepted if the Mindray number is not clearly visible. Please provide the model number, serial
III
number, and a brief description of the reason for return; 2.
Freight policy: The customer is responsible for freight charges when this product is shipped to Mindray for service (this includes customs charges);
3.
Return address: Please send the part(s) or equipment to the address offered by Customer Service department.
Company Contact Manufacturer: Address:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, ShenZhen 518057, P.R.China,
Phone:
+86 755 26582479 26582888
Fax:
+86 755 26582934 26582500
EC-Representative:
Shanghai International Holding Corp. GmbH(Europe)
Address:
Eiffestraβe 80, 20537 Hamburg Germany
Phone:
0049-40-2513175
Fax:
0049-40-255726
IV
Table of Contents Copyright ···· I Intellectual Property Statement ····························································································I Responsibility on the Manufacturer Party ············································································I Warranty·····························································································································III Exemptions ························································································································III Return Policy······················································································································III 1
2
3
Using This Manual 1.1.
Scope ··············································································································· 1-2
1.2.
Introduction ······································································································ 1-2
1.3.
Conventions Used in This Manual ··································································· 1-3
1.4.
Special Terms Used in This Manual································································· 1-3
1.5.
Symbols ··········································································································· 1-4
1.6.
Definitions ······································································································ 1-12
Analyzer Structure
5
6
2-1
2.1
Product Name········································································································ 2-1
2.2
System Introduction······························································································· 2-1
2.3
System Composition······························································································ 2-7
2.4
Software Structure ································································································· 2-8
2.5
LIS Connection ···································································································· 2-19
Upgrade 3.1
4
1-1
3-1
Software upgrade ·································································································· 3-1
Mechanical System
4-1
4.1
Front of the Analyzer ····························································································· 4-1
4.2
Back of the Analyzer······························································································ 4-3
4.3
Left of the Analyzer ································································································ 4-4
4.4
Right of the Analyzer ····························································································· 4-6
Fluidic System
51
5.1
Fluidic Components and Functions ······································································· 5-1
5.2
Reagent Consumption··························································································· 5-2
5.3
Sample Dilution Flowchart····················································································· 5-3
5.4
Introduction of Fluidic Channels ············································································ 5-5
5.5
Introduction of Basic Sequence············································································· 5-6
Hardware System 6.1
6-1
Introduction ············································································································ 6-1 1
Table of Contents
7
8
6.2
Data Board············································································································· 6-5
6.3
Drive Board·········································································································· 6-18
6.4
Power Board ········································································································ 6-25
6.5
USB Interface Board···························································································· 6-30
6.6
Touchscreen Control Board ················································································· 6-31
6.7
Volumetric Board ································································································· 6-32
6.8
Sample Compartment Connection Board···························································· 6-34
6.9
Indicator Board ···································································································· 6-35
Servicing
7-1
7.1
General ·················································································································· 7-1
7.2
Disassembling the Panels ····················································································· 7-2
7.3
Replacing the Hardware parts and Cable connection ··········································· 7-6
7.4
Replacing the Power Supply Assembly······························································· 7-16
7.5
Replacing the Display Assembly ········································································· 7-17
7.6
Replacing the Touch Screen················································································ 7-18
7.7
Replacing the Recorder Assembly ······································································ 7-19
7.8
Replacing the valve, pumps, and other liquid system parts ································ 7-20
7.9
Replacing the counting bath assembly································································ 7-29
7.10
Replacing the syringe assembly ···································································· 7-35
7.11
Replacing the sample probe assembly·························································· 7-37
7.12
Replacing the sample compartment assembly·············································· 7-47
7.13
Replacing the start key ·················································································· 7-56
7.14
Micro-Switch Assembly Replacement···························································· 7-57
7.15
Fluidic Support-bracket Assembly ································································· 7-58
7.16
Front Panel Detection Assembly···································································· 7-59
7.17
Ambient Temperature Sensor Replacement·················································· 7-60
7.18
Cap Assembly ································································································ 7-61
7.19
Gain Adjustment····························································································· 7-62
7.20
Motor Type, Position and Different Application List ······································· 7-64
7.21
The Check List After Material Replacement ·················································· 7-64
Maintaining your analyzer
8-1
8.1 General Guidelines ··································································································· 8-1 8.2 Operation guidance of Quality Control and Calibration ············································ 8-2 9
10
Error Information
9-1
9.1
Error Information and Code ··················································································· 9-1
9.2
Error analysis and processing ··············································································· 9-2
9.3
Error diagnosis assisted by abnormal histogram ················································ 9-12
9.4
Error diagnosis assisted by abnormal pulse figure ············································· 9-21 Appendices
A-1
2
1
Using This Manual
This chapter explains how to use this service manual. This manual states in detail the way to service the BC-3600 and BC-3300 analyzers. Before servicing the BC-3600 and BC-3300, read and understand the manual carefully for servicing the equipment properly and for your safety. This manual is to be used in conjunction with the operator's manuals of BC-3600 and BC-3300.It does not contain information and procedures already covered in the operator's manuals of BC-3600 and BC-3300.
Be sure to operate and service the analyzer strictly as instructed in this manual and the operator's manuals.
1-1
Using This Manual
1.1. Scope To use this manual effectively, you need the following capabilities:
Comprehensive knowledge of circuit and fluidics;
Comprehensive knowledge of reagents;
Comprehensive knowledge of controls;
Comprehensive knowledge of troubleshooting;
Mastering the way to operate this analyzer;
Using basic mechanical tools and understand related terminology;
Using a digital voltmeter (DVM) and an oscilloscope;
Reading pneumatic/hydraulic schematics and understand related terminology.
1.2. Introduction This manual comprises 9 chapters and 6 appendices. Refer to the table below to find the information you need.
If you want to …
See …
learn about the system and software structures of BC-3600
Chapter 2 System Structure
and BC-3300 learn about the installation requirements and the way to
Chapter 3 System Installation
upgrade the software of BC-3600 and BC-3300
and Software Upgrade
learn about the mechanical system structure of BC-3600 and
Chapter 4 Mechanical System
BC-3300 learn about the fluidic system, reagent dosage, channels and
Chapter 5 Fluidic System
basic sequence of BC-3600 and BC-3300 learn about the hardware system and board composition,
Chapter 6 Hardware System
adjustment and test points and general troubleshooting methods of BC-3600 and BC-3300 learn about how to service the BC-3600 and BC-3300
Chapter 7 Servicing
learn about how to maintain the BC-3600 and BC-3300
Chapter 8 Maintenance
learn about how to troubleshoot the common errors of
Chapter 9 Troubleshooting
BC-3600 and BC-3300 learn about the main spare parts of BC-3600 and BC-3300
Appendix A List of Spare parts
learn about the main wearing parts of BC-3600 and
Appendix B List of Wearing
BC-3300
Parts
learn about the circuit diagram of BC-3600 and BC-3300
Appendix C Circuit Diagram
learn about the schematic diagram of the fluidic system of
Appendix D Fluidic Diagram
1-2
Using This Manual BC-3600 and BC-3300 learn about the function of each valve and pump of BC-3600
Appendix E Pump and Valve
and BC-3300
Function Diagram
learn about the tubing connection of BC-3600 and BC-3300
Appendix F Tubing
1.3. 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-3600 and BC-3300 ××为 italic letters indicate titles of the chapters that are referred
××
to
"Menu" the "
" button on the screen.
All illustrations in this manual are provided as examples only. They may not necessarily reflect your analyzer setup or data displayed.
1.4. Special Terms Used in This Manual When you read …
It means … to press the desired item lightly with your finger; or to
Click
left-CLICK it with the mouse. to CLICK the desired edit box and use the external keyboard or the pop-up keyboard to enter the desired characters or
ENTER
digits; or to scan the number by using the bar-code scanner. to move the cursor to the character or digit that you want to delete by clicking the left button of the mouse or using [←][→][Home][End], and then delete the character after the
DELETE
cursor by pressing [Del], or delete the character before the cursor by pressing [BackSpace] ([←] on the upper right part of the soft keyboard).
SELECT from
××
pull-down list (for pull-down list)
to CLICK the down arrow button of the desired box to display the pull-down list, (and DRAG SCROLL BAR) to browse and then CLICK the desired item; or to press the keys ([↑][↓][PageUp][PageDown]) to browse the current list and
1-3
Using This Manual press [ENTER] to select the desired item.
1.5. Symbols You will find the following symbols in this manual. When you see…
Then… read the statement below the symbol. The statement is alerting you to an operating hazard that can cause personnel injury. read the statement below the symbol. The statement is alerting you to a possibility of analyzer damage or unreliable analysis results. read the statement below the symbol. The statement is alerting you to information that requires your attention. read the statement below the symbol. The statement is alerting you to a potentially biohazardous condition.
You may find the following symbols on the analyzer, reagents, controls or calibrators. When you see…
It means… CAUTION, CONSULT ACCOMPANYING DOCUMENTS. BIOLOGICAL RISK
HIGH VOLTAGE
EXERCISE CAUTION WHEN WORKING AROUND TO AVIOD PRICKING PROTECTIVE EARTH (GROUND)
ALTERNATING CURRENT
1-4
Using This Manual FOR IN VITRO DIAGNOSTIC USE
BATCH CODE
USE BY (YYYY-MM-DD)
SERIAL NUMBER
MEASUREMENT AUTHORIZATION SYMBOL DATE OF MANUFACTURE
MANUFACTURER
THIS ELECTRO-INFORMATIONAL PRODUCT CONTAINS CERTAIN POISONOUS OR HARMFUL SUBSTANCE. ITS ENVIRONMENTAL LIFT TIME IS 20 YEARS. IT CAN BE USED WHTHIN 20 YEARS, AFTER THAT IT SHALL BE RECYCLED. Be sure to observe the following precautions for the safety of patients and operators when you are servicing the analyzer.
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 harm to human health.
Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g. ethanol) around the analyzer. Otherwise, the risk of explosion may exist.
When servicing the analyzer, be sure to turn off the power. Servicing the analyzer when it is on may bring risk of electric shock or damage to electronic components.
Connect the analyzer to a socket having sole fuse and protective switch. Do
1-5
Using This Manual 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 maintenance, keep your clothes, hairs and hands from the moving parts, such as sample probe, clipper and piercer.
Possible mechanical movement of the warned position may lead to personal injury during the normal operation, removal and maintenance.
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
Improper maintenance may damage the analyzer. Maintain the analyzer strictly as instructed by the service manual and inspect the analyzer carefully after the maintenance.
For problems not mentioned in the service manual, contact Mindray customer service department for maintenance advice.
To prevent personal injury or damage to equipment components, remove metal jewelry before maintaining or servicing electronic components of the equipment.
Electrostatic discharge may damage electronic components. If there is a possibility of ESD damage with a procedure, then do that procedure at an ESD workstation, or wear an antistatic wrist strap.
When the front cover is open, be sure to close the sample compartment door, or the sample compartment assembly or the front cover may be damaged.
When transporting the analyzer, the screw at its bottom may scratch your hands, please exercise caution or wear gloves.
1-6
Using This Manual
This equipment must be operated by skilled/trained medical professionals.
Samples, controls, calibrators and waste are potentially infectious. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
All the analyzer components and surfaces are potentially infectious. Take proper protective measures for operation or maintenance.
The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.
Figure 1-1
1-7
Using This Manual
① Warning, potential biohazardous risk.
②
Make sure the analyzer is properly grounded.
To avoid electric shock, disconnect power cord prior to removing or replacing fuse.
Use fuse only with the type and rating specified.
1-8
Using This Manual
Figure 1-2
① Warning, the sample probe is sharp and may contain biohazardous substance. Exercise caution to avoid contact with the probe when working around it.
1-9
Using This Manual
Figure 1-3
① Warning, make sure the protective cover is properly installed before operation.
② Warning
Do not put your hands close to the sampling assembly when the analyzer is running.
Warning, the sample probe is sharp and may contain biohazardous substance. Exercise caution to avoid contact with the probe when working around it.
③ Warning, the sample probe is sharp and may contain biohazardous substance. Exercise
1-10
Using This Manual caution to avoid contact with the probe when working around it.
Figure 1-4
① Warning, risk of electric shock.
1-11
Using This Manual
1.6. Definitions There are two sampling mode: open vial mode and closed tube mode.
Open vial mode
The operator presents the tube or open vial evacuated collection tube containing blood sample to the sample probe, and press the "Aspirate" key to collect sample. The analyzer of which the sampling mode is open vial is called open vial analyzer.
Closed tube mode
The operator puts the capped tube into the sample compartment, the analyzer collects sample by piercing through the tube cap. The analyzer of which the sampling mode is closed tube is called closed tube analyzer.
1-12
2
Analyzer Structure
2.1 Product Name Name: Auto Hematology Analyzer. Models: BC-3600, BC-3300.
2.2 System Introduction BC-3600 and BC-3300 are in-vitro diagnosis equipments with the functions of blood cell counting, WBC 3-differential and measurement of HGB concentration under proper working environment. The purpose of the analyzers is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.
Scope: the products can be applied for clinical diagnosing reference and scientific research.
Environment of use: the analyzers shall be used in medical laboratories with standardized management; they can not be used as portable equipment.
Operator: the operators must be skilled/trained medical professionals.
2.2.1 System Configuration The whole system includes the analyzer, accessories and reagents; users can choose to configure data management software, scanner, printer or PC.
2.2.2 Electrical Parameters Table2-1 Power supply of the analyzer Voltage
(100V-240V~)±10%
Input Power
≤180 VA
Frequency
50/60±1Hz
Only install fuses of specified specification on the analyzer.
Specification of the fuse: 250V
T3.15AH 2-1
Analyzer Structure
2.2.3 Dimension and Weight
Height Depth Width Figure 2-1Dimensional sketch map Table2-2Dimension and weight Width (mm)
Depth (mm)
Height (mm)
≤395
≤450
≤445 (without foot)
Weight (Kg) ≤28
2.2.4 Throughput The throughput of open vial analyzers under whole blood mode is no less than 60 samples per hour; the time needed for the analysis of one sample is no more than 60s (the sample dilution time is not included for predilute mode). The throughput of closed tube analyzers under whole blood mode is no less than 60 samples per hour; the time needed for the analysis of one sample is no more than 60s (the sample dilution time is not included for predilute mode).
2.2.5 Parameters The analyzer determines 21 parameters (WBC, RBC, PLT, HGB, etc.) and 3 histograms (WBC, RBC and PLT) of blood samples. Table 2-3Table of parameters English name
Abbreviation
White Blood Cell count
WBC
Lymphocyte number
Lymph#
Mid-sized Cell number
Mid#
Granulocyte number
Gran#
Lymphocyte percentage
Lymph%
2-2
Analyzer Structure Mid-sized Cell percentage
Mid%
Granulocyte percentage
Gran%
Red Blood Cell count
RBC
Hemoglobin concentration
HGB
Mean Corpuscular Volume
MCV
Mean Corpuscular Hemoglobin
MCH
Mean Corpuscular Hemoglobin Concentration
MCHC
Red Blood Cell Distribution Width Coefficient of
RDW-CV
Variation Red Blood Cell Distribution Width Standard
RDW-SD
Deviation 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
Table2-4Table of histograms White Blood Cell Histogram
WBC Histogram
Red Blood Cell Histogram
RBC Histogram
Platelet Cell Histogram
PLT Histogram
2.2.6 Performance Specifications 2.2.6.1 Background or Blank Counting Background counting is performed by the analyzer automatically when it is started up. The following requirements must be met. Blanking counting: test the diluent for 3 consecutive times, and take the highest result. The following requirements must be met. Table 2-5 Requirements on background or blank counting Parameter WBC
Requirement 9 ≤ 0.3 × 10 / L
RBC
≤ 0.03× 10 / L
HGB
≤1g/L
HCT
≤ 0.5 %
PLT
≤ 5× 10 / L
12
9
2-3
Analyzer Structure
2.2.6.2 Reproducibility Run the sample meeting the reproducibility requirements for 10 consecutive times on the analyzer, then calculate the CV(%) and SD, the requirements in Table 2-6 and 2-7 must be met.
Table 2-6 Whole blood reproducibility requirements Condition
Parameter
CV%/SD
7.0 ~ 15.0 × 10 / L
≤ 2.5
WBC
4.0 ~ 6.9 × 10 / L
≤ 3.5
RBC
3.50 ~ 6.50 × 10
HGB
100 ~ 180 g/L
≤ 1.5
MCV
70.0~ 110.0 fL
≤ 0.5
9
9
12
≤ 2.0
/L
≤ 4.0
150 ~ 500 × 10 / L 9
PLT
9
100~149× 10 / L
≤ 5.0
30~50%
≤ 3.0
Lymph%
20%~50%
≤ 1.5(SD)
Mid%
2%~13%
≤ 1.5(SD)
Gran%
30%~70%
≤ 3.0(SD)
HCT
Table 2-7 Predilute reproducibility requirements Parameter
Condition
CV%
WBC
4.0 ~ 15.0 × 10 / L 9
12
RBC
3.50 ~ 6.50× 10
≤ 4.0 ≤ 2.0
/L
HGB
110 ~ 180 g/L
≤ 2.0
MCV
80.0 ~ 110.0 fL
≤ 1.5
9
PLT
≤ 8.0
100~500× 10 / L
2.2.6.3 Linearity Requirements Prepare and analyze samples of different concentration, calculate the slope and intercept by linearity regression equation, then calculate the theoretical value, and the deviation between the theoretical value and the test value, the requirements in Table 2-8 must be met. Table 2-8 Linearity Requirements Parameter
Linearity range
Deviation
range
blood mode) WBC
9
0.0~100.0×10 /L 9
100.1~300×10 /L
9
(Whole
Deviation range (Predilute mode) 9
±0.30×10 /L 或±5%
±0.50×10 /L or ±5%
±9%
±18%
2-4
Analyzer Structure
RBC① HGB PLT②
12
12
±0.05×10 /L or ±5%
±0.05×10 /L or ±5%
0~280g/L
±2g/L or ±2%
±2g/L or ±3%
9
9
0~1000×10 /L 9
1001~3000×10 /L HCT
12
0~8.00×10 /L
0~60%
9
±10×10 /L or ±10%
±10×10 /L or ±10%
±12%
±20%
±4% (HCT value) or ±6%
/
(deviation)
Test suggestion: 12
① When testing RBC linearity range 7.00~8.00×10 /L, use sample of which the HCT≤ 60%; 9
② When testing PLT linearity range 1001~3000×10 /L, use sample of which the RBC≤ 6.
2.2.6.4 Carryover The carryover impact of high concentration sample to low concentration sample. Test method: mix the high value sample (centrifuged high value control or specialized high value linearity control) within the range of
Table 2-9, test the sample for 3 consecutive times,
and then mix and test the low value sample (diluted low value control, dilution rate 1:10) within the range of Table 2-9 for 3 consecutive times, then calculate the carryover. The requirements in Table 2-10 must be met. Table 2-9 Requirements on high and low value controls of carryover calculation Parameter
Unit
High concentration
9
WBC
×10 /L
Low concentration
> 15.0
< 3.0
RBC
12
×10 /L
> 6.0
< 2.00
HGB
g/L
> 200
< 40
9
> 300
< 100
PLT
×10 /L
Table 2-10 Carryover requirements Parameter
Carryover
WBC
≤0.5%
RBC
≤0.5%
HGB
≤0.5%
PLT
≤1.0%
2.2.7 Functions 2.2.7.1 Startup and Shutdown When starting up the analyzer, initialization will be performed to prepare the analyzer for counting. Different startup cleaning sequence will be performed base on the latest shutdown status to ensure the success of background counting. The analyzer provides the function to skip fluidics initialization to the users of service level and above.
2-5
Analyzer Structure The shutdown procedure will be performed according to different shutdown status.
2.2.7.2 Password and User Management In order to protect the security of product setup and data, you have to possess the password to be able to adjust the parameters and perform the extra functions.
2.2.7.3 Screen Navigation The analyzer provides screen navigation function so that users can easily go to their target screen.
2.2.7.4 Status Indication The analyzer/system status indication function is provided on the analyzer screen or by configuring LED in the hardware system.
2.2.7.5 Setup Users can customize the settings of the analyzer on the software screen. 1. 2.
The configuration files are saved in the analyzer. The analyzer must allow users to modify certain configurations. E.g.: Users can set up date/time, reference range, parameter unit, communication-related parameters, print format, etc.
3.
For the FDA model, users can set whether to display or print RUO parameters through the authorization protocol.
4.
For the FDA model, users can set "QC lockout", if this function is activated, sample analysis can be started only after the daily QC passes.
2.2.7.6 Standby The analyzer will enter standby mode when no fluidic operation has been performed for a certain period of time. The analyzer will exit the standby mode when operation is triggered by users.
2.2.7.7 Self Test The analyzer system provides self test and inspection function to ensure proper running.
2.2.7.8 Sample Review After analyzing a sample, the analyzer saves the sample information and analysis result automatically. Operators can review all parameters and histograms of the saved samples.
2.2.8 Sample Compartment The tube holder in sample compartment can be fitted with adapters of different specifications. The specifications of supported tubes are:
Evacuated collection tube: diameter: 10~13.5mm; height (with cap): 40~85mm.
Capillary collection tube: diameter: 10~13.5mm; height (with cap): 40~65mm.
Centrifugal tubes.
2-6
Analyzer Structure
2.2.9 Operating, Storing and Running Environment Table 2-11 Temperature and Humidity Requirements Optimal operating
Storage environment
environment
Running environment
Temperature
15℃~30℃
-10℃~40℃
15℃~35℃
Humidity
30%~85%
10%~93%
30%~85%
Atmospheric
70kPa~106kPa
50kPa~106kPa
70kPa~106kPa
pressure
2.3 System Composition 2.3.1 Functional Composition The analyzer system has the following functions: reagent system, sample distribution, sample preparation, sample analysis, signal processing, parameter analysis, data management, status monitoring, schedule control, information processing, human-machine interface, power source, cleaning and maintenance. The relations of the functional modules are shown in Figure 2-2. Under the control of the schedule control and information processing functional module, the other modules work together according to the designed procedure and requirement to realize the core task of the analyzer - sample analysis.
Fluid
Air flow
2-7
Reagents
Signal stream
Analyzer Structure Figure 2-2 System function block diagram
2.3.2 Reagents In order to ensure the accuracy of analysis results, you shall use the reagents, controls and calibrators specified by Shenzhen Mindray Bio-medical Electronics Co., Ltd. For details, refer to Table 2-12. Table 2-12 Applicable reagents, controls calibrators Item
Name
Diluent
M-30D DILUENT
Lyse
M-30CFL LYSE
Rinse
M-30R RINSE
Probe cleanser
PROBE CLEANSER
Control
B30 or BC-3D
Calibrator
S30 or SC-CAL PLUS
2.4 Software Structure 2.4.1 Menu Structure The top level structure of the system menu includes 8 functional options: analysis, review, QC, calibration, setup, service, logoff and shutdown. Operators can enter the screens to perform the functions of the analyzer through the system menu. The " " indicates there is sub-menu under the option. Refer to Figure 2-3 -- Figure 2-7 for the full menu structure. The menu structure of service access level:
2-8
Analyzer Structure
Figure 2-3 Top level menu and QC sub-menu
Figure 2-4 Top level menu and calibration sub-menu
2-9
Analyzer Structure
Figure 2-5 Top level menu and setup sub-menu
Figure 2-6 Top level menu and setup sub-menu(2)
2-10
Analyzer Structure
Figure 2-7 Top level menu and service sub-menu
2.4.2 Password The login service ID is "Service", password is "s 3600!", case sensitive and space required. With service access level, you can perform all functions that are open to common users and some other special functions: 1、 Transfer factor calibration function: 1) Under whole blood mode, click "Menu"—>"Calibration"—>"Calibrator", finish the calibration successfully, exit and save the calibration factors. 2) Click "Menu"—>"Calibration"—>"Transfer factor" to enter the screen in Figure 2-8, run the sample used in the above step for 5 consecutive times under whole blood mode, check if CV(%) meets the requirements in Table 2-13; if not, cancel a abnormal result and calculate again (results of at least 5 analyses required), then check if the requirements in Table 2-13 are met.
2-11
Analyzer Structure
Figure 2-8Analysis screen of transfer factor under whole blood mode Table 2-13 Whole blood CV range Param
WBC
RBC
HGB
MCV
PLT
≤2.0%
≤1.5%
≤1.5%
≤0.5%
≤4.0%
eter CV value 3) Click the "Predilute" button to switch to the screen of predilute mode, as Figure 2-9 shows;
2-12
Analyzer Structure
Figure 2-9 Analysis screen of transfer factor under predilute mode 4) Click the Diluent icon, perform diluent dispensing for 7 consecutive times; 5) Add 140µl of calibrator in to the diluent, mix thoroughly and then run the mixture for more than 5 times under the predilute mode. The CV(%) values must meet the requirements of Table 2-14, and the calibration factors are within the range [0.75, 1.25]. Table 2-14 Range of CV value under predilute mode Param
WBC
RBC
HGB
MCV
PLT
≤4.0%
≤2.0%
≤2.0%
≤1.5%
≤8.0%
eter CV value 2、 The gain of WBC and RBC can be adjusted, see Figure 2-10;
2-13
Analyzer Structure
Figure 2-10 Gain setup screen 3、 In the service setup screen, you can set up languages, software upgrade, volume of the volumetric tube, analyzer SN, sample probe positioning adjustment, background information monitoring (auto adjust of analysis time), rinse photocoupler calibration, etc. The following section will introduce the sample probe positioning adjustment and rinse photocoupler calibration functions. 1) Sample probe positioning adjustment: Tool: the positioning calibration clamp of sample probe sampling position Procedure: open the cover as Figure 2-11 shows, open the sample compartment door, take out the tube holder adapter from the compartment, put the positioning calibration clamp to the sample compartment, and then close the compartment door.
2-14
Analyzer Structure
Figure 2-11 Sample compartment Click the "Aspirate pos." under the "X direction motor" as shown in Figure 2-12, and click "Start", then click the "Move Left" or "Move Right" button to move the sample probe to the top of the positioning hole of the fixture, check if the tip of the probe is right against the positioning hole, then click "Save" to save the setting.
Figure 2-12 Sample probe positioning adjustment Note: the tip of the probe must be right against the positioning hole (judge by visual inspection). 2) Rinse photocoupler calibration Tool: 101 slot-headed screwdriver Procedure:
as
Figure
2-13
shows,
click
"Menu""Setup""Service
Setup""Photocoupler Cal.", the dialog box shown in Figure 2-14 will pop up.
2-15
Analyzer Structure
Figure2-13 Rinse photocoupler calibration menu
Figure2-14 Rinse photocoupler calibration screen
2-16
Analyzer Structure ① Click "Start" and then click "OK", the dialog box "Priming diluent" will pop up, then an instruction message will be displayed, use the slot-headed screwdriver to rotate the potentiometer VR1(RINSE) on the drive board (see Figure 2-15) counter-clockwise until the D22 (RINSE-LED) turns on. Note: continue to rotate the VR1 for 180 degrees after the D22 turns on.
Figure 2-15 ② Connect the connector of the rinse pickup tube to the fitting on the back panel of the analyzer, click "OK" and then click "Finish", the dialog box "Priming rinse" will pop up, check the calibration status then: if "Pass" is displayed (see Figure 2-16), that means the calibration succeeded. The reference voltage and measured voltage are displayed as "Reference(V)" (1.8-3.0V) and Actual(V) in Figure 2-16.
"PASS" displayed
Figure 2-16 Note: ① Rotate the VR1 for 180 degrees more after the D22 turns on, and make sure the LED is illuminated. ② Do not modify the value in the edit box Max(V), Min(V) and Factor(V); ③ If calibration cannot be done successfully due to the quality of the photocoupler itself and the PCBA or photocoupler must be replaced, then recalibration is needed. The dialog box "Remove the Rinse tube from the container and press [OK] to continue." will pop up, press [OK] to drain the tubing; then do as instructed by the prompt - "1. Adjust rinse photocoupler potentiometer till the RINSE-LED turns on; 2 Put the Rinse tube into the container and press [OK]to close the dialog box; 3. Click [Finish] button" to prime rinse after calibration is done.
2-17
Analyzer Structure
4、 The reproducibility and carryover functions are available.
Figure 2-17 Menu of reproducibility and
carryover
5、 Check the replacement status of boards and CF card automatically. If the software system is started and logged in by user of service level, then a prompt will guide the user to restore the critical data.
Figure 2-18 1) If a new CF card is replaced, follow the guidance to select "Restore" and restore the critical data to the CF card. 2) If a new data board is replaced, follow the guidance to select "Backup" and backup the data to the data board. 3) If only the drive board is replaced, no special action shall be taken, the data will not be
2-18
Analyzer Structure lost. 6、 Users of the service level can export special information, see the figure below.
Figure 2-19
2.5 LIS Connection 2.5.1 LIS Setup and Adjustment 1. Click "Menu""Setup""System Setup""Communication", the following screen will be displayed.
Figure 2-20 Communication setup screen
2-19
Analyzer Structure 2. Select network communication or serial port communication base on the physical medium used. 3. If serial port communication is selected, communication can be realized when the parameter settings of the serial port are identical with those of the LIS software. The handshake function shall also be set up base on the LIS software used. 4. If network communication is selected, it is recommended that direct-coupled network wire is used, and the major IP addresses such as 192.168.0. or 10.0.0.* are set up. When connected to LAN, set up the IP address per the IP rules of the LAN. ACK synchronous transmission shall also be set up base on the LIS software settings. If you are not sure about that, use the default setup.
2.5.2 Connection Testing It is recommended that you use Mindray data management software to perform actual communication testing, or you can use the testing software developed by a compatible software developer.
2.5.3 Analysis of Communication Failure 1. For abnormal serial port connection, check parameter settings. If the settings are identical to those of the analyzer, replace serial port wire. 2. For abnormal network connection, check parameter settings. If the settings are correct, check if the connection is normal by using ping. (If network firewall is installed in the computer of the LIS end, turn off the firewall). If the ping command fails to restore the connection, check if the network wire is well connected. If physical connection is good, and the communication parameters and protocol settings are correct, but communication failure persists, check if the LIS software complies with the communication protocol. Refer to the operator's manual for the communication protocols.
2-20
3
Upgrade
3.1 Software upgrade 3.1.1 Preparation 1、The whole software upgrade procedure will take about 6~11mins. 2、What to do if there is an ERROR during the upgrade 1)If there is a Mounting Failure,please restart the analyzer and run software upgrade again. 2) If there is a Upgrade Failure, please check the upgrade package in your USB flash disk and run software upgrade again. Do NOT restart or power off the analyzer immediately. 3、Requirements of the USB flash disk used in this upgrade. 1)Please use well-known brand USB flash disk. 2)Format(FAT32) the USB flash disk before use it. 3)Do NOT remove the USB flash disk during the upgrade.
3.1.2 Upgrade procedure 1、Copy the update file to a formatted USB flash disk. 2、Insert the USB flash disk into the USB interface of analyzer (See figure 3-1)
Figure 3-1 3、Log in the BC-3600 with Service Engineer username and password. 4、Run Setup Service Setup Setup Start Upgrade (see figure 3-2), and then click “Yes” in the dialog box (see figure 3-3).
3-1
Upgrade
Figure 3-2
Figure 3-3
NOTES: 1)Make sure the UBS storage connected well to the USB interface of the Analyzer. 2)After you click ‘Yes’ to start the upgrade, the system will start to read and analyze the configuration in the UBS storage and this will last for about 1min. Please wait for the pop-up upgrade confirmation dialog box. 3)Do NOT remove the USB flash disk during the upgrade.
3-2
Upgrade 5、software upgrade. 1) See the following software upgrade screen:
Figure 3-4 2) Click the ‘Upgrade’ button to start the upgrade. You will see the upgrade preparation dialog. (See figure 3-5)
Figure 3-5 3) The upgrade preparation lasts for about 1 min, after that, you will see the upgrade confirm dialog. (See figure 3-6)
Figure 3-6 4) Click ‘Yes’ to start the upgrade. (See figure 3-7)
3-3
Upgrade
Figure 3-7 5) You may need to restart the instrument for several times during the upgrade. (See figure 3-8)
Figure 3-8 6) Upgrade succeeded. (See figure 3-9)
Figure 3-9 7) Upgrade failed. (See figure 3-10)
3-4
Upgrade
Figure 3-10 8) After you finish all the process, please restart the instrument. (See figure 3-11)
Figure 3-11 6、After upgrade finished, log in with the service engineer username and password. Run Service Version to check upgrade items. (See figure 3-12)
Figure 3-12
3-5
Upgrade
3.1.3 Notes and Prompts of Errors 1、During the upgrade, the software will check whether the hardware and software are matched. If not, select the proper language, click OK to start upgrade. (See figure 3-13)
Figure 3-13 2、If upgrade failed, export the debug data. (See figure 3-14)
Figure 3-14
3-6
4
Mechanical System
4.1 Front of the Analyzer
Figure 4-1 Front of the analyzer(closed tube model)
1 --- Touchscreen
2 --- Indicator
3 --- Sample compartment door
4 --- USB interface
5 --- Recorder
4-1
Mechanical System
Figure 4-2 Front of the analyzer(open vial model)
1 --- Touchscreen
2 --- Indicator
3 --- Sample probe
4 --- Aspirate key
5 --- USB interface
6 --- Recorder
4-2
Mechanical System
4.2 Back of the Analyzer
Figure 4-3 Back of the analyzer
1 --- USB interface 1
2 --- USB interface 2
3 --- Network interface
4 --- Serial port
5 --- Power switch
6 --- Waste outlet
7 --- Rinse outlet
8 --- Diluent outlet
4-3
Mechanical System
4.3 Left of the Analyzer
Figure 4-4 Left of the analyzer (open vial model)
1 --- Top cover
2 --- Front cover assembly
3 ---
4 --- Back panel assembly
Side door of electrical system
5 --- Bottom panel assembly
4-4
Mechanical System
Figure 4-5 Left of the analyzer (closed tube model)
1 --- Top cover
2 --- Front cover assembly
3 --- Side door of electrical system
4 --- Back panel assembly
5 --- Bottom panel assembly
4-5
Mechanical System
4.4 Right of the Analyzer
Figure 4-6 Right of the analyzer (open vial model)
1 --- Top cover
2 --- Front cover assembly
3 ---
4 --- Door lock
Side door of fluidic system
5 --- Aspirate key
6 --- Back panel assembly
7 --- Bottom panel assembly
4-6
Mechanical System
Figure 4-7 Right of the analyzer (closed tube model)
1 --- Top cover
2 --- Front cover assembly
3 ---
4 --- Door lock
Side door of fluidic system
5 --- Aspirate key
6 --- Back panel assembly
7 --- Bottom panel assembly
4-7
5
Fluidic System
5.1 Fluidic Components and Functions 5.1.1 Sample Probe Aspirating and dispensing sample.
5.1.2 Probe Wipe Cleaning the exterior and interior walls of the sample probe.
5.1.3 Pump
Gas pump (GP): provide pressure to the vacuum chamber for generation of bubbles.
Waste pump (LP): draining probe wipe, WBC bath, RBC bath and vacuum chamber and building vacuum.
5.1.4 Syringes
Sampling syringe (Asp-Syringe): full measuring range is 100µl; aspirating fixed quantity of sample, dispensing the sample and aspirating the diluted sample again.
Diluent syringe (Dil-Syringe): full measuring range is 10ml; dispensing fixed quantity of diluent to WBC and RBC bath, providing diluent to probe wipe.
Lyse syringe (Lyse-Syringe): full measuring range is 2.5ml, motivated by the same motor with the diluent syringe; dispensing lyse.
5.1.5 Valves
Fluid valve and magnetic valve: diaphragm form, controlled by electric magnetic power. Controlling the directional flow of fluid or air.
5.1.6 Baths
WBC bath: composed of front bath, back bath and aperture. Providing room for the mixing of WBC sample; measuring HGB and WBC.
RBC bath: composed of front bath, back bath and aperture. Providing room for the mixing of RBC sample; measuring RBC/PLT.
Vacuum chamber: build and store stable vacuum for the impedance counting of WBC and RBC, clean the back baths and drain volumetric tubes.
Pressure chamber: build and store stable pressure for generation of bubbles in all baths.
5-1
Fluidic System
WBC isolation chamber: providing air lock to block outside disturbance.
RBC isolation chamber: providing air lock to block outside disturbance.
5.1.7 Volumetric Tubes
WBC volumetric tube: its volume is 300ul, measuring volume of the WBC sample to be analyzed.
RBC volumetric tube: its volume is 200ul, measuring volume of the RBC sample to be analyzed.
5.1.8 Filters
Filter of WBC volumetric tube: filtrate the air entering the WBC volumetric tube.
Filter of RBC volumetric tube: filtrate the air entering the RBC volumetric tube.
GP filter: filtrate the air entering the gas pump.
Customized filter: filtrate the impurities and scraps from the probe wipe.
Filter of the isolation chamber: filtrate the impurities and scraps from the baths.
5.2 Reagent Consumption There are four counting modes: OV-WB, OV-PD, CT-WB and CT-PD. See Table 5- 1 for the reagent volume consumed in one analysis cycle of a sample. Table 5- 1Reagent consumed in one analysis cycle of a sample Reagent consumed in Item
one analysis cycle of a
Name
sample Whole blood
Predilute
Diluent
M-30D DILUENT
≤ 28mL
≤ 28mL
Lyse
M-30CFL LYSE
≤ 0.35mL
≤ 0.35mL
Rinse
M-30R RINSE
≤ 8mL
≤ 8mL
0
0
Probe cleanser
PROBE CLEANSER
Control
B30、BC-3D
/
Calibrator
S30、SC-CAL PLUS
/
5-2
Fluidic System
5.3 Sample Dilution Flowchart 5.3.1 Whole Blood Mode The whole blood analysis cycle completes in 60s. The analysis procedure is as follows: 1) Aspirate 17ul of sample, the sample probe ascends and the exterior wall of the probe is cleaned; 2) Dispense 6ul of sample to the probe wipe to wash it off; 3) Add diluent into the WBC bath and dispense 9ul of sample into the WBC bath, mix them to get the first dilution sample for WBC and HGB measurement. 4) The sample probe ascends and its exterior wall is cleaned, the residual sample is washed off by diluent in the probe wipe. 5) The sample probe descends to the WBC bath and aspirate 34ul of sample again, diluent is added and the second dilution sample is dispensed into the RBC bath, and mix them for RBC/PLT counting. 6) Add lyse into the WBC bath, and mix thoroughly; 7) Analyzing the sample; 8) When the analysis completes, clean and zap the WBC/RBC bath, release the pressure in the vacuum chamber. See Figure 5-1 for the dilution procedure of whole blood mode:
Figure 5-1 Dilution procedure of whole blood mode
5-3
Fluidic System
5.3.2 Predilute Mode The predilute analysis cycle includes 3 function sequences (2 for closed tube models): diluent dispensing sequence, cleaning sequence (open vial models) and analyzing sequence. The procedure is as follows: 1) The sample probe dispense 380ul of diluent to a centrifugal tube and 20ul of sample in the capillary tube is added in to the centrifugal tube, mix them to form the diluted sample; 2) The sample probe aspirate 146.34ul of sample, and diluent is added into the WBC bath to form the first dilution sample for WBC and HGB measurement; 3) The sample probe ascends and its exterior and interior walls are cleaned; 4) The sample probe descends to the WBC bath and aspirate 37.39ul of sample again, diluent is added and the second dilution sample is dispensed into the RBC bath, and mix them for RBC/PLT counting. 5) Add lyse into the WBC bath, and mix thoroughly; 6) Analyzing the sample; 7) When the analysis completes, clean and zap the WBC/RBC bath, release the pressure in the vacuum chamber. You can see from the above procedures that the analysis cycles of predilute mode and whole blood mode are only different in the operations of sampling and dispensing into WBC bath, therefore this section will only introduce the different parts. See Figure 5-2 for the dilution procedure of predilute mode:
5-4
Fluidic System
Figure 5-2 Dilution procedure of predilute mode
5.4 Introduction of Fluidic Channels 5.4.1 WBC/HGB Channel
All reagents:1)M-30PCFL lyse (lysing HGB, PLT and separating basophils from other WBCs ); 2) M-30PD diluent (cleaning, providing reaction and measurement environment)
Analysis principles: impedance method (analyzing WBC); colorimetric method (analyzing HGB)
Analysis parameters: WBC, HGB
Graphic information: WBC histogram
Dilution ratio:1:302 (WB); 1:369.77 (PD)
Measurement volume: 300µl
Function description: Mix 9ul of blood and 2.35ml of diluent in the WBC bath, provide 34ul of first dilution sample to the RBC bath and add 0.35ml of lyse into it, mix them; then aspirate the mixed sample into the back bath through the aperture by the vacuum of the vacuum chamber. The cells are analyzed when they pass the aperture. Volume of the sample analyzed is measured by the volumetric tube.
5-5
Fluidic System
5.4.2 RBC/PLT Channel
All reagents: diluent (diluting, cleaning, providing conductive environment, isometric processing of cells)
Analysis principles: impedance method
Analysis parameters: RBC, PLT
Graphic information: RBC histogram, PLT histogram
Dilution ratio:1:20000 (WB); 1:22333.07 (PD)
Measurement volume: 200µl
Function description: the sample probe aspirates 34ul of sample (dilution ratio: 1:262.11) from the WBC bath, add 0.8ml of mixture of the sample and diluent into the RBC bath to form the sample of dilution ratio 1:20000 with another 1.8ml of diluent; Mix them and aspirate the sample by vacuum of the vacuum chamber into the back bath through the aperture. The cells are analyzed when they pass the aperture. Volume of the sample analyzed is measured by the volumetric tube.
5.5 Introduction of Basic Sequence 5.1.1 Whole Blood Analysis Sequence This section introduces the working procedure of sample probe in the measurement sequence first, then all the other working procedures are introduced in detail.
5.5.1.1 Sampling and dispensing procedure The working procedure of sample probe is indicated in Figure 5- 3. See section 5.3 for the sample dilution procedure. The working procedure of sample probe: a) Sample aspirating ① piercing(closed tube models) ② aspirating 17ul of sample. b) First dilution ① When aspiration finishes, the sample probe ascends; ② The sample probe moves to the top of the WBC bath; ③ The sample probe descends to the WBC bath and dispenses 9ul of sample. c) Aspirating sample from the WBC bath ① The sample probe ascends from the WBC bath, and removes the residual sample in the probe wipe; ② The sample probe descends to the WBC bath and aspirates 34ul of first dilution sample. d) Second dilution in the RBC bath ① When aspiration finishes, the sample probe ascends from the WBC bath; ② The sample probe moves to the top of the RBC bath; ③ The sample probe descends to the RBC bath, and dispenses 0.8ml of mixture of the sample and diluent. 5-6
Fluidic System ④ Initialize position of the sample probe by command INIT.
? ? RBC
WBC
Diluent
a)
?
Blood sample
b) ?
?
? RBC
RBC
WBC
c)
?
First dilutio n sampl e
Secon d dilution sample
? WBC
d)
Figure 5- 3 Sampling and dispensing procedure
5.5.1.2 The measurement procedure This section highlights the whole blood measurement sequence of the closed tube models. The measurement sequence consists of sample aspiration, dispensing, dilution, mixing, counting, and cleaning.
Sampling (0~12.6s)
The actions are:
Pre-piercing: the pre-piercing process of sample probe (for closed tube models) to release the pressure in the tube before sample aspiration.
Cleaning the exterior and interior walls of sample probe: when piercing finishes, the sample probe ascends to home position, meanwhile its exterior and interior walls are washed. See the following figure.
5-7
Fluidic System V01
V01 Diluent V02
V02
V04
Diluent
V04 10ml
10ml 100ul
100ul
V19
V19
Waste
Waste a) Wash exterior wall of sample probe
b) Wash interior wall of sample probe
Figure 5- 4 Fluidic passages of sample probe cleaning
The sample probe descends to the sampling position, and then moves to the piercing position, the syringe withdraws for 2ul to create separating bubbles. Then the sample probe descends to the lowest aspirating position to prepare for sample aspirating. Besides, the fluidic passages of draining and dispensing of the WBC bath are indicated in Figure 5- 5 and Figure 5- 6; Under the effect of vacuum, rinse flows through and washes the WBC and RBC back baths and their volumetric tubes, the fluidic passage of washing the WBC back bath and volumetric tube is indicated in Figure 5- 7; When the washing progress ends, Valve 5 and 6 opens to drain the volumetric tubes.
5-8
Fluidic System
V01 Diluent V04 V02
V03 10mL (SR3)
2.5mL (SR1)
WBC bath
Lyse
Isolation chamber
V16 Waste Figure 5- 5 Fluidic passage of draining of the WBC bath
V01 Diluent V04 V02
V03 2.5mL (SR1)
WBC bath
10mL (SR3)
lyse
Figure 5- 6 Fluidic passage of dispensing of the WBC bath
5-9
Fluidic System
V05
V07
Atmosp heric pressure
WBC bath Volumetric board
Pressure
V14 Rinse Vacuum chamber
V09
Isolation chamber
V10 V18 V16
Waste
Figure 5- 7Fluidic passages of washing WBC back bath and volumetric tube
Aspirating sample: the sampling syringe aspirates 17ul of sample at 6.5~8.5s; and 800ul of diluent is added to the RBC bath after it is drained;
Ascending to home position: the sample probe ascends to home position at 9.3~11.6s, and its exterior wall is washed; by now, the sampling procedure is finished.
Other actions finished during the sampling procedure:
After sample dispensing of the WBC bath finishes (7s) and the fluid level stabilizes, the HGB voltage and WBC aperture voltage (the constant-current source is opened at 10.5s in advance) is read at 10.5s.
Sample Dispensing, Dilution and Mixing (11.5~30.8s)
The actions are: Dispensing sample for the first time: the sample probe removes 6ul of sample in the probe wipe at 11.5~12.3s.
Dispensing sample for the second time: the sample probe moves to the top of WBC bath and descends into the bath; the diluent syringe dispenses 1150 ul of diluent into the WBC bath, then the sample probe dispensed 9 ul of sample and swings; when sample dispensing finishes, the diluent syringe dispenses 1200ul of diluent into the WBC bath again; Valve 10 opens, and blows one small bubble and 3 big bubbles into the WBC bath in turn. By now, the first dilution of sample finishes.
The sample probe ascends with its exterior and interior walls washed: when the second sample dispensing finishes, the sample probe ascends to home position with its exterior and interior walls washed; besides, 2700ul of diluent is dispensed into the RBC bath. 5-10
Fluidic System
Second aspiration in the WBC bath: the sample probe descends to the WBC bath and aspirates 34 ul of fluid at 19.9~21s.Valve 17 opens, and the RBC bath is drained.
The sample probe ascends: when the second aspiration finishes, the sample probe ascends to home position with its exterior wall washed; besides, 1800 ul of diluent is added to the RBC bath at 24.5~25.5s.
Adding sample to RBC bath, and lyse to WBC bath: the sample probe moves to the RBC bath and descends into the bath; the lyse syringe dispenses 350ul of lyse into the WBC bath, the fluidic passage is indicated in Figure 5- 8; the diluent syringe discharges 800 ul of fluid (mixture of first dilution sample and diluent) through the sample probe. Valve 10 opens at 26.65~27.25s, the pressure chamber blows bubbles into the WBC bath; then a bubble that can last for 0.05s is blowed into the WBC bath, and 3 bubbles are blowed into the RBC bath in turn; Finally, the sample probe restores to the original position with its exterior wall washed.
V03 2.5mL (SR1) WBC bath
Lyse
Figure 5- 8 Fluidic passage of lyse dispensing of the WBC bath
Other actions finished during the sample dispensing, dilution and mixing procedure:
Build the vacuum needed for analysis, total time consumed is 7.9s;
Build the pressure needed for bubble generation;
RBC aperture voltage inspection: same as WBC aperture voltage inspection;
The sample compartment door opens at 12s to prepare for the next analysis cycle.
Analysis
The actions are:
Measuring volume of volumetric tube: valve 7 opens after WBC bubbling finishes for a while and valve 8 opens after RBC bubbling finishes for a while, the fluidic passage is indicated in Figure 5- 9; the closing of valve 7 and valve 8 is finished by the ending cleaning cycle started when the WBC and RBC down photocouplers are triggered. 5-11
Fluidic System
V07
V05
V06
V08
Volumetric board
RBC bath
WBC bath
Volumetric board
V14 Vacuum chamber
V15 Rinse
V18 Waste
Figure 5- 9 Fluidic passages of WBC and RBC analysis
The photocoupler of volumetric board is opened at 25.7s.
Cleaning when analysis ends
The actions are:
The ending cleaning sequence is an independent sequence, it is started by the software automatically base on the information obtained during the analysis;
Fluid discharging of RBC and WBC baths: open valve 17, the RBC bath starts to discharge fluid; open valve 16, the WBC bath starts to discharge fluid;
Fluid dispensing of RBC and WBC baths: 1400 ul of fluid is dispensed into the RBC and WBC bath respectively;
Washing RBC and WBC back baths: when valve 8 and valve 15 open at the same time, the RBC back bath will be washed by rinse under the effect of vacuum; when valve 7 and valve 14 open at the same time, the WBC back bath will be washed by rinse under the effect of vacuum.
Draining the vacuum chamber: open valve 9 to drain the vacuum chamber. Resetting of the diluent syringe and sample probe assembly: the diluent syringe aspirates 2100 ul of fluid, then valve 1 opens, the syringe returns to home position and dispenses fluid to the RBC bath at the same time; the sample probe assembly returns to home position.
The sample probe aspirates air bar and returns to home position: the sample probe moves to the piercing position and withdraws for 2ul and then returns to home position.
Zapping: zapping starts when fluid dispensing of WBC bath completes for a while.
Calculating the volume of rinse consumed: the software reads from the command to calculate the volume of rinse consumed.
Detecting rinse status: sensor in the analyzer detects if the rinse container is empty; when alarming for no rinse, the residual volume of rinse must be able to support the on-going analysis.
The major difference between the whole blood analysis sequences of open vial models and closed tube models lies in the sampling procedure, the open vial sequence involves no piercing action, but its sampling time point and the cleaning action after sampling are the same 5-12
Fluidic System with those of the closed tube sequence, therefore the whole blood analysis sequences of open vial models will not introduced in detail.
5.1.2 Predilute Measurement Sequence The predilute analysis cycle includes 3 function sequences (2 for closed tube models): diluent dispensing sequence, cleaning sequence (open vial models) and analyzing sequence. The predilute measurement procedure: (1)The sample probe dispense 380ul of diluent to a centrifugal tube and 20ul of sample in the capillary tube is added in to the centrifugal tube, mix them to form the diluted sample. (2)The sample probe aspirate 146.34ul of sample, and diluent is added into the WBC bath to form the first dilution sample for WBC and HGB measurement. (3)The sample probe ascends and its exterior and interior walls are cleaned. (4)The sample probe descends to the WBC bath and aspirate 37.39ul of sample again, diluent is added and the second dilution sample is dispensed into the RBC bath, and mix them for RBC/PLT counting. (5)Add lyse into the WBC bath, and mix thoroughly; (6)Analysis. (7)When the analysis completes, clean and zap the WBC/RBC bath, release the pressure in the vacuum chamber. You can see from the above procedures that the analysis cycles of predilute mode and whole blood mode are only different in the operations of sampling and dispensing into WBC bath, therefore this section will only introduce the different parts. See section 5.3.2 for the dilution procedure of predilute mode.
5.5.2.1 Dilution dispensing sequence The procedure is indicated in Figure 5- 10:
a) closed tube models
b) open vial models
Figure 5- 10 Diluent dispensing flowchart
5.5.2.2 Cleaning sequence after diluent dispensing Introduction: 5-13
Fluidic System 1. This sequence applies to open vial models only. 2. The sequence cleans the exterior wall of the sample probe, initializes diluent syringe by command INIT; the sampling syringe withdraws for 2ul to create a separating air bar, the system restores to "Ready" status.
5.5.2.3 Predilute Measurement Sequence Introduction:
Sampling:
1. The diluent syringe withdraws for 100ul through the probe wipe tube; 2. WBC/RBC bath is zapped for 3s; 3. The diluent syringe aspirates 146.34ul of sample; 4. When aspirating finishes, valve 01 closes 0.1s after valve 04 closes.
Sample dispensing of WBC bath:
1. The diluent syringe pushes sample in the sampling tube into the WBC bath to form the first dilution sample; 2. Sample volume of the second aspiration is 37.39ul; 3. The predilute measurement takes 1.5s more than the whole blood measurement due to the zapping action added before analysis; 4. The other parts of sequence are the same as those of the whole blood measurement sequence, only the fluid volumes are different in some steps. 5. The major difference between the closed tube and open vial models is the position of the sample probe under the "Ready" status.
5.1.3 Startup/Shutdown Sequence 5.5.3.1 Startup sequence There are three types of startup sequence: 1 startup after normal shutdown; 2 startup after abnormal shutdown; 3 startup after performing "Prepare To Ship" procedure.
Startup after normal shutdown
This sequence includes the troubleshooting sequence 1, fluidics initializing sequence and startup sequence after normal shutdown. 1. Troubleshooting sequence 1, refer to the corresponding section. 2. Fluidics initializing sequence, refer to the corresponding section. 3. Startup after normal shutdown
5-14
Fluidic System
Figure 5- 11Startup procedure after normal shutdown Introduction: (1)
There are zapping and flushing operations at the beginning to avoid clogging after long term of probe cleanser soak.
(2)
0.5ml of lyse is discharged to make sure the tube mouth is filled with reagent.
(3)
Push back 200ul of diluent to the cleanser tube to wash off the cleanser at the closed end of valve 12.
(4)
Empty RBC charging line to avoid crystallizing of the cleanser spills on the wall of the bath which may influence the PLT background.
(5)
Empty the sample probe and dispense fluid: after emptying the sampling tube, 5-15
Fluidic System dispense fluid at a higher speed so that the bubbles in the sampling tube can be removed effectively. (6)
The sample probe dispenses fluid in the WBC bath: removing all the bubbles in the sampling tube.
(7)
Cleaning the two baths: cleanser volumes of WBC bath 4ml, 4.6ml, 5.5ml; cleanser volumes of RBC bath 4ml, 4ml, 5ml, generating bubbles during the cleaning process to strengthen the cleaning effect.
(8)
Emptying WBC, RBC baths and the back baths, switching among valve 16 ,17, 7 and 8 to strengthen the cleaning effect.
Startup after abnormal shutdown
This sequence includes the troubleshooting sequence 1, fluidics initializing sequence and startup sequence after normal shutdown. 1. Troubleshooting sequence 1, refer to the corresponding section. 2. Fluidics initializing sequence, refer to the corresponding section. 3. Startup after normal shutdown
Figure 5- 12 Startup procedure after abnormal shutdown Introduction: (1)
When starting up the analyzer after abnormal shutdown, there may be some
5-16
Fluidic System residual sample in the fluidic components, so the exterior and interior walls of the sample probe must be cleaned repeatedly by fluid discharging of the sample probe and probe wipe. (2) (3)
0.5ml of lyse is discharged to make sure the tube mouth is filled with reagent. Push back 200ul of diluent to the cleanser tube to wash off the cleanser at the closed end of valve 12.
(4)
Remove the bubbles in the sampling tube through fluid discharging for multiple times.
(5)
Clean the two baths repeatedly to remove the possible residual sample.
(6)
Zapping for 4s to avoid clogging.
(7)
Wash tubes of the back baths twice to remove the residual sample in the tubes or volumetric tubes.
Startup after performing "Prepare To Ship" procedure
This sequence includes the troubleshooting sequence 1, fluidics initializing sequence and overall reagent priming sequence. 1. Troubleshooting sequence 1, refer to the corresponding section. 2. Fluidics initializing sequence, refer to the corresponding section. 3. See section 5.5.3.5 for the overall reagent priming sequence.
5.5.3.2 Shutdown sequence The probe cleanser soak sequence (general and intensified, refer to 5.5.4.7 and 5.5.4.8 for details), intensified shutdown unclogging sequence (refer to 5.5.4.2 for details) and shutting down sequence will be performed in turn during the shutdown process. As per the different probe cleanser soak sequences, the shutdown sequence can be classified into two kinds: 1 shutdown after general probe cleanser soak, 2 shutdown after intensified probe cleanser soak. The operations of the shutting down sequence are: washing the exterior wall of the sample probe and soaking the probe in the WBC bath.
5.1.4 Cleaning/Maintenance Sequence 5.5.4.1 Unclogging sequence Introduction: 1. Drain the two baths. 2. Valve 9 opens to connect the pressure chamber and vacuum chamber and build pressure. 3. Flush the aperture for 4s and drain the fluid. 4. Add 3.5ml of fluid in the two baths respectively. 5. Zap the two baths for 4s respectively. 5-17
Fluidic System 6. Wash the tubes of the back baths. Empty the vacuum chamber and release vacuum.
5.5.4.2 Zapping sequence Introduction: 1. Build vacuum in the vacuum chamber, zap the two baths for 4s. 2. Drain the two baths and add 3.5ml of fluid in the two baths respectively. 3. Wash the tubes of the back baths. Empty the vacuum chamber and release vacuum.
5.5.4.3 Flushing sequence Introduction: 1 The flushing sequence is almost the same as the unclogging sequence, only it involves no zapping operation.
5.5.4.4 Draining sequence of the baths Introduction: 1 Drain the two baths for 3s.
5.5.4.5 Priming sequence of the baths Introduction: 1. Drain the two baths and add 3.5ml of fluid in the two baths respectively. 2. The function is activated after the baths are drained. The baths may need to be serviced during the draining process, the tubes of the back baths need to be washed. 3. Drain the vacuum chamber and release vacuum.
5.5.4.6 Cleaning sequence of the baths Introduction: 1. 4.5ml of fluid is added to the two baths respectively, and bubbles are generated to strengthen the cleaning effect. 2. Drain the two baths and add 3.5ml of fluid into the two baths respectively, open valve 18 and the fluidic pump for a while to release pressure in the pressure chamber.
5.5.4.7 General probe cleanser soak sequence This sequence includes soaking sequence and the cleaning sequence after soaking.
Soaking procedure:
5-18
Fluidic System
Figure 5-13 Soaking procedure
Introduction: the soaking process consists of three steps. Step 1: soak the WBC aperture and interior wall of the sample probe with 100% probe cleanser. Step 2: soak the WBC and RBC front/back baths with 30.77% and 38.46% probe cleanser respectively. Step 3: soak the WBC and RBC front/back baths with 26.32% and 21.05% probe cleanser respectively. The operations are: 1. The sampling syringe withdraws for 2ul to form a separating air bar. 2. The sample probe aspirates 1.8ml of probe cleanser, the two baths are drained, the sample probe ascends with its exterior wall washed. 3. The sample probe dispenses 1ml of probe cleanser into the WBC bath to form 100% probe cleanser. 4. The sample probe dispenses 2.6ml of mixture of probe cleanser and diluent into the RBC bath to form the high concentration compound (30.77%) for the first soak. 5. The sample probe dispenses 1.6ml of diluent into the WBC bath to form the high concentration compound (38.46%) for the first soak. 5-19
Fluidic System 6. After soaking for about 2 minutes, dispenses 1.2ml of diluent to the two baths to dilute the probe cleanser, which will be used for the long term soaking of the front and back baths (WBC:26.32%; RBC:21.05%). 7. Build vacuum and aspirate fluid: aspirate for 6s from the WBC bath, the volume aspirated is about 232ul; aspirate for 8s from the RBC bath, the volume aspirated is about 236ul; When the aspiration finishes, release the vacuum in the vacuum chamber. 8. Meanwhile, the sample probe aspirates 50ul of fluid from the RBC bath for soaking of the interior wall of sample probe and the tube. 9. Soak the tubes for 2 minutes and then start the cleaning procedure.
Cleaning procedure:
5-20
Fluidic System
Figure 5-14Cleaning procedure
Introduction: the front and back baths, sampling tube, waste valve shall be cleaned to remove residual probe cleanser. 1. Add probe cleanser to the WBC bath; when draining the WBC bath, switch on/off valve 16 for multiple times to soak the waste valve with probe cleanser (for about 5s) to remove residual probe cleanser. 2. Add probe cleanser to the RBC bath; when draining the RBC bath, switch on/off valve 17 for multiple times to soak the waste valve with probe cleanser (for about 5s) to remove residual probe cleanser. 5-21
Fluidic System 3. The sample probe dispenses 7.8ml of probe cleanser to the RBC bath to clean the sampling tube and remove bubbles in the tubing. 4. Discharge fluid to the probe wipe twice, meanwhile the sample probe ascends to avoid residual probe cleanser on the exterior wall of the sample probe or in the probe wipe. 5. Build vacuum, wash tube of the back bath, switch on/off valve 7 and 8 for multiple times. 6. Empty the vacuum chamber, switch on/off valve 18 for multiple times. 7. Drain the baths and build pressure to 40kpa. 8. Flushing the apertures. 9. Drain the two baths and add 3.5ml of fluid into the baths respectively, zap the baths for 4s and build vacuum to -24kp. 10. Wash the back baths, switch on/off valve 7 and 8 for multiple times to strengthen the cleaning effect of the valves and remove residual probe cleanser. 11. Empty the vacuum, switch on/off valve 18 for multiple times to strengthen the cleaning effect of the valves and remove residual probe cleanser. 12. Release the pressure, the analyzer restores to "Ready" status.
5.5.4.8 Intensified probe cleanser soak sequence Soaking procedure:
5-22
Fluidic System
Figure 5-15 Soaking procedure
Introduction: the intensified probe cleanser soak procedure is almost the same as the general probe cleanser soak procedure, the only difference lies in the dilution ratio of probe cleanser. 5-23
Fluidic System
Cleaning procedure: The cleaning operations of the intensified and general probe cleanser soak procedure are almost the same, the only difference lies in the occurrence time of the operation.
5.5.4.9 Draining sequence of the tubing Procedure:
Figure 5- 16Draining procedure of the tubing
Introduction: 1.
Build vacuum in the vacuum chamber to drain the back bath and rinse tubes.
2.
Drain the RBC bath, the diluent syringe withdraws for 1.3ml to drain the charging line of RBC bath.
3.
The lyse syringe aspirates and discharges lyse to the WBC bath for multiple times to drain the lyse tube.
5-24
Fluidic System 4.
The diluent syringe aspirates and discharges diluent to the WBC bath for multiple times to drain the diluent tube.
5.
The sampling syringe aspirates 80ul of fluid.
6.
The sample probe goes inside the WBC bath to drain the sampling tube.
7.
Drain the charging line and the waste tube of the probe wipe.
8.
Push the 80ul of fluid to the syringe inlet.
9.
After build vacuum in the vacuum chamber, open the rinse tubes and empty tubes of the back baths.
10. Empty the vacuum chamber and build vacuum at the same time, open V5 and V6 of the volumetric tube and dry the volumetric tube. 11. Release vacuum and pressure, the syringes return to home position, the sample probe returns to the sampling position.
5-25
6
Hardware System
6.1 Introduction The hardware system consists of 8 boards, which are power board, data board, drive board, indicator board, touch screen control board, volumetric boars, sample compartment connector board, and USB interface board; the system also includes the drive and detect components that require power supply (such as motors, valves, pumps, sensors, display, and filter of input power) and the wires connecting boards and components.
6.1.1 Function Diagram See Figure 6-1 for the function diagram of the hardware system.
Figure 6-1Function diagram of the hardware system The hardware system consists of five modules, which are system power, data stream channel, central system, drive components and peripherals. The function of each module is as follows: 1.
System power: providing power of various specifications to the boards, components and devices.
2.
Data stream channel: extracting, adjusting, amplifying and collecting and preprocessing of signals.
3.
Central control system: data collection and processing, result display, sample storage, etc. Besides, the central control system controls and responds to all peripherals.
4.
Drive/detect components: controlling valves, pumps and motors, monitoring photocouplers and other major parameters, collecting detection information and 6-1
Hardware System sending alarms. 5.
Peripherals and interfaces: display/touchscreen, recorder, USB interfaces (for printer, keyboard and barcode scanner), Ethernet interface and LIS serial port. Besides, peripherals includes status indicator, key-presses and aspirate key input.
6.1.2 Electric Connection Diagram See Figure 6-2 for the electric connection diagram of the hardware system.
6-2
Hardware System
Figure 6-2 Electric connection diagram of the hardware system
6-3
Hardware System
6.1.3 Troubleshooting the System The errors of the hardware system include board errors, wire errors and component errors. Generally ,the troubleshooting methods of the three types of errors can be found in the following sections; however, if the power supply of the hardware system cannot be ensured (the analyzer cannot be electrified, or self-shields right after power on), the errors shall be fixed on the system level. 1 Troubleshooting procedure when the analyzer cannot be electrified (the indicators of the drive board and the data board are both off) (1) Check if the AC input wire outside the analyzer is firmly connected, if not, re-plug the wire. (2) Power off the analyzer, check if the wire of the power input filter is firmly connected, if not, re-plug the wire. (3) If step (1) and (2) cannot remove the error, replace the power input filter (see Figure 6-3); if the error persists, do step (4).
Figure 6-3 Power input filter (4) Replace the power board or assembly. 2 Troubleshooting procedure when the analyzer self-shields right after power on (1) First, unplug the wires of the drive board and data board (see Figure 6-4), see if the power can be started; if not, check if the wire is damaged; if so, replace the wire; otherwise replace the power board or assembly. If the power can be started normally, the problem of power assembly can be excluded.
Figure 6-4Sockets of drive board and power board
6-4
Hardware System (2) After completing step (1), plug the two wires on of the drive board in turn to see if the power can be started; if yes, the problem of the drive board can be excluded, the data board needs to be replace; if no, unplug the wire of the volumetric board; if the power can be started, that means the volumetric board or its wire is short-circuited, the volumetric board or its wire shall be replaced; if not, that means the drive board is short-circuited, the drive board shall be replaced. If the power can be started normally, troubleshoot the error per the following sections.
6.2 Data Board 6.2.1 Introduction The data board consists of the analog and digital parts, the analog part filters, amplifies, outputs and processes signals to obtain the signals that are suitable for A/D data conversion. The digital part processes, outputs, controls and transmits data. It is the core part of the data board or even the entire hardware system. Section 6.2 is the servicing and troubleshooting guideline of the data board.
6.2.2 Structure Introduction of Functions See Figure 6-5 for the structural diagram of the data board.
Figure 6-5Structural diagram of the data board You can see from Figure 6-5, the data board consists of the analog circuit and digital circuit. The analog circuit adjusts and amplifies the WBC, RBC, PLT and HGB signals to make sure the signals are turn and suitable for A/D conversion; the A/D module is the interface of the analog circuit and digital circuit, it collects the sensing signals and other monitoring signals, and converts analog signals into digital signals; the digital circuit processes data, stores and outputs results. Besides, the digital circuit takes on the control and communication tasks, it is the core part of the data board or even the entire hardware system. 1. Analog module 6-5
Hardware System
Figure 6-6 Structural diagram of the analog module The analog module of the data board consists of RBC/PLT channel, WBC channel, HGB channel and A/D conversion part, its functions are:
Adjusting analog power
Adjusting volume signal
Data collection
2. Digital module
Figure 6-7 Structural diagram of the digital module The structure of the digital module is "CPU+FPGA", see Figure 6-7.The functions of the digital module are:
Preprocessing of data
Supporting peripherals interfaces 6-6
Hardware System
Extending control interfaces
Description
Adjusting analog power
Converting the input power into the power that meets the requirement of the board.
Adjusting volume signal
Driving, collecting, adjusting, amplifying the RBC, PLT, WBC and HGB signals, and sending the signal to A/D part for conversion.
Data collection
The A/D circuit converts the analog signals in to digital signals that can be recognized by the digital module (FPGA and CPU), and sends the signals to FPGA for processing.
Preprocessing of data
The FPGA filters the digital signals collected by the A/D part, saves the particle parameters and sends the data to CPU through Flexbus by means like interrupt, etc.
Supporting peripherals interfaces
The CPU module provides the platform for software operation to the system, and provides interfaces for peripherals, including interfaces of the drive board, LIS system, recorder, indicator board, touchscreen control board, LCD display, Ethernet, USB printer, USB barcode scanner, keyboard and USB, etc. It also provides JTAG interface for the online programming of FPGA configuration chip and BDM interface for CPU debugging.
Extending control interfaces
The FPGA provides control logic and interfaces for LCD, recorder, CF card, touchscreen and door detector.
Definition of Interfaces There are 19 interface sockets on the data board, the functions of the interfaces are listed in Table 6-1. See Figure 6-8 for the position of the interfaces. Table 6-1 Functions of data board interfaces Interface
Function
No. of pins
Description
P1
Interface of CF card
50
/
J1
Interface of RBC/PLT sensor
3
Connect RBC/PLT sensor
J2
Interface of WBC sensor
4
Connect WBC sensor
J3
Interface of HGB sensor
4
Connect HGB sensor
J4
+/-12V power interface of the analog
3
Connect +/-12V analog
circuit
power
6-7
Hardware System
J5
120V power interface for aperture
3
zapping
Connect zapping power
J7
Interface of recorder
6
/
J8
JTAG interface for FPGA debugging
10
/
J9
Interface of LCD display
20
/
J12
RS232 serial port of LIS system
11
/
J13
BDM interface for CPU debugging
26
/
J14
Interface for door detector
2
/
J16
Interface of touchscreen control
24
/
board, indicator board and inverter J17
Interface of power drive board
20
/
J18
+5V, +12V power interface of the
4
/
analog circuit J20
Double-port USB-A interface
12
/
J22
Ethernet interface
10
/
J29
Single-port USB-A interface
6
/
J30
Single-port USB-A interface
6
/
6-8
Hardware System
J17
J14
J7
J16
J9
J8
J3
J4
J30
J29 J5 J20
J22
J2
J12
J1 J13
J18
P1
Figure 6-8 Position of the interfaces on the data board
6.2.3 Adjustment and Testing All the adjustable parameters of the board can be adjusted by command. You can set up the parameters on the software interface of the analyzer.
Function Definition of LEDs See Table 6-2 for the function definition of data board LEDs. Table 6-2 Function of data board LEDs Indicator
Function
+5V_POWER
+5V power indicator of the digital circuit
+12V_POWER
+12V power indicator of the digital circuit
FPGA_LED
Indicator of FPGA logical work, it filters when the logical work goes on normally
D3/D7/D8/D9
Indicator for software debugging
D17
-12V power indicator of the analog circuit
6-9
Hardware System
D20
+12V power indicator of the analog circuit
D21
-5V power indicator of the analog circuit
D22
+5V power indicator of the analog circuit
D38
Indicator for completing of FPGA configuration
D44
Indicator of network collision, flickers when collision occurs
D45
100M network indicator, flickers when transmitting data
D46
10M network indicator, flickers when transmitting data
D47
Indicator of network connection
D48
Indicator of the network full-duplex mode
D70
Power indicator of J30 single-port USB
D71/D72
Power indicator of J20 double-port USB
D73
Power indicator of J29 single-port USB
D100/D101
Connection indicator of J20 double-port USB
D102
Connection indicator of J29 single-port USB
D103
Indicator of USB-HUB chip connection
Function Definition of Test Points See Table 6-3 for the function definition of data board test points. Table 6-3 Function of data test points No.
Name or location of test points
Description
1
VCC
Digital 5V power
2
VDD
Digital 3.3V power
3
D_1V8
Digital 1.8V power
4
D_1V5
Digital 1.5V power
5
D_2V5
Digital 2.5V power
6
D_1V25VRF
Digital 1.25V power
7
D_1V25VTT
Digital 1.25V power 6-10
Hardware System 8
D_1V2_FPGA
Digital 1.2V power
9
TP36
5V power of USB interfaces
10
TP37
5V power of USB interfaces
11
TP38
5V power of USB interfaces
12
TP39
5V power of USB interfaces
13
TP168
Voltage of button battery, 1.8V~4V
14
IRQ1
Interrupt signal when FPGA inputs to CPU
15
IRQ2
Interrupt signal when FPGA inputs to CPU
16
IRQ3
Interrupt signal when FPGA inputs to CPU
17
IRQ4
Interrupt signal when FPGA inputs to CPU
18
IRQ5
Interrupt signal when PCI-to-USB chip inputs to CPU
19
IRQ6
Interrupt signal when FPGA inputs to CPU
20
IRQ7
Interrupt signal when FPGA inputs to CPU
14
+12V
Analog 12V power
15
-12V
Analog -12V power
16
+5V
Analog 5V power
17
-5V
Analog -5V power
18
+56V
56V voltage of constant-current source
19
NCONST
On/off control signal of constant-current source, the RBC/WBC constant-current source is on when electrical level is low RBC constant-current source/zapping on/off control signal; zapping
20
NSEL_R
when the electrical level is low, RBC constant-current source when it is high WBC constant-current source/zapping on/off control signal; zapping
21
NSEL_W
when the electrical level is low, WBC constant-current source when it is high Zapping power on/off control signal, the zapping power is on when
22
NBURN
23
NHLED
24
RBC1
RBC signal that has been amplified (level 1)
25
RBC2
RBC signal that has been amplified (level 2)
26
RBC5
RBC signal that has been amplified (level 3)
27
RBC
Final output of RBC signal
28
RBCF
RBC signal at ADC entry
29
PLT1
PLT signal that has been amplified (level 1)
30
PLT2
PLT signal that has been amplified (level 2)
31
PLT
Final output of PLT signal
32
PLTF
PLT signal at ADC entry
33
WBC1
WBC signal that has been amplified (level 1)
34
WBC2
WBC signal that has been amplified (level 2)
35
WBC3
WBC signal that has been amplified (level 3)
the electrical level is low HGB lamp on/off control signal, the lamp is on when the electrical level is low
6-11
Hardware System 36
WBC
Final output of WBC signal
37
WBCF
WBC signal at ADC entry
38
HGB1
39
HGB
Final output of HGB voltage
40
VR_H
ADC reference source voltage of HGB channel
41
VR_W
ADC reference source voltage of WBC channel
42
VR_R
ADC reference source voltage of RBC channel
43
VR_P
ADC reference source voltage of PLT channel
44
HGND
Digital ground
45
-12VM
Monitoring voltage of analog -12V power
46
+12VM
Monitoring voltage of analog +12V power
47
+56VM
Monitoring voltage of 56V constant-current source
48
RHOLE
RBC aperture voltage
49
WHOLE
WBC aperture voltage
HGB voltage that has been amplified (primary level), normally it is negative
Note: refer to Table 6-3 for the location of all test points.
Definition of Keys See Table 6-4 for the definition of keys on the data board: Table 6-4 Definition of keys on the data board No.
Function
S12
Manual resetting of the system
6.2.4 Troubleshooting Table 6-5 lists the common errors and troubleshooting methods of the data board from the hardware point of view, the errors caused by software are not included. But many hardware errors must be inspected by the software. You need to check the following items before troubleshooting the errors: 1. Check if the wires are firmly connected to the data board; 2. Check if the wires are connected to the sockets of the same No., and if the wires are cracked or damaged. 3. Check if the input power of socket L18 is normal (test +5V and +12V with a multimeter). 4. Check if the indicator of the data board is in normal condition according to Table 6-5. After confirming all the above items are in normal condition, do as instructed in Table 6-5 to troubleshoot the errors. Table 6-5 Analyzing and handling data board errors No. 1
Phenomenon LCD
blanks
Judging criteria 1: Press the reset button S12 on the data board, if the 6-12
Solution Press S12
Hardware System out
error is cleared, it can be concluded as a program failure; if not, do step 2. Replug 2: Check if the data board if firmly connected to the inverter and LCD display. Replug the connection wires, if the error is cleared, it can be concluded as an insecure connection error; if not, do step 3.
the
connection wires
of
the
data board and the
inverter
and
LCD
display. Replace 3: Replace the connection wires of the data board and the inverter and LCD display, if the error is cleared, it can be concluded as a connection wire failure; if not, do step 4.
the
connection wires
of
the
data board and the
inverter
and
LCD
display. 4:Test the resistance of F4 with multimter, if the result is not 0, the error is caused by the protective tube F4; if not, do step 5. 5: Test voltage of the test point VDD with the multimeter, if the result is not 3.135V~3.465V, U62 failure can be concluded; if not, do step 6. 6: Test voltage of the test point D_2V5 with the multimeter, if the result is not 2.375V~2.625V, U60 failure can be concluded; if not, do step 7. 7: Test voltage of the test point D_1V8 with the multimeter, if the result is not 1.71V~1.89V, U63 failure can be concluded; if not, do step 8. 8: Test voltage of the test point D_1V5 with the multimeter, if the result is not 1.425V~1.575V, U61 failure can be concluded; if not, do step 9. 9: Test voltages of the test points D_1V25VRF and D_1V25VTT with the multimeter, if the results are not 1.188V~1.313V, U65 failure can be concluded; if not, do step 10.
6-13
Replace data board
the
Hardware System
10: Test voltage of R27 with the multimeter, if the result is 0V, then X6 failure can be concluded; if not, do step 11. 11: Test voltage of R27 with the multimeter, if the result is 1.6V, but the voltage of R31 is 0V, then U11 failure can be concluded; if not, do step 12. 12: Test voltage of R273 with the multimeter, if the result is 0V, then X2 failure can be concluded; if not, do step 13. 13: If D38 is off, reprogram correct version of FPGA logic; if D38 is still off, then FPGA chip (U49) failure can be concluded; if not, do step 14. 14: Replace LCD display and the inverter (display
Replace
assembly), if the error is cleared, then the display
display
assembly failure can be concluded.
assembly
the
Replug 1: Replug the connection wires of the data board and the inverter and LCD display, if the error is cleared, it can be concluded as an insecure connection failure; if not, do step 2.
the
connection wires
of
the
data board and the
inverter
and
LCD
display. Replace 2: Replace the connection wires of the data board and 2
LCD display
the inverter and LCD display, if the error is cleared, it
flickers
can be concluded as a connection wire failure; if not, do step 3.
the
connection wires
of
the
data board and the
inverter
and
LCD
display. 3: Replace the data board, if the error is cleared, the display memory (U4) failure or crystal oscillator (X6) failure can be concluded; if not, do step 4.
Replace data board
4: Replace the inverter and LCD display (display
Replace
assembly), if the error is cleared, then the display
display
assembly failure can be concluded.
assembly
6-14
the
the
Hardware System
1: Check if the data board if firmly connected to the LCD display. Replug the connection wires, if the error is cleared, it can be concluded as an insecure connection error; if not, do step 2.
Replug
the
connection wire of the data board and LCD display Replace
3
2: Replace the connection wires of the data board and
connection
the LCD display, if the error is cleared, it can be
wire of the data
concluded as a connection wire failure; if not, do step 3.
board and LCD display
Spotted LCD display
the
3: Check if there is solder joint on U6 weld, if yes, cut off the solder joint when power is off. Reconnect the power, see if the error is cleared, if yes, the solder joint failure can be concluded; if not, do step 4.
Cut
off
solder
the joint
with a knife.
4: Replace the data board, if the error is cleared, the
Replace
data board failure can be concluded; if not, do step 5.
data board
5: Replace the inverter and LCD display (display
Replace
assembly), if the error is cleared, then the display
display
assembly failure can be concluded.
assembly
the
the
1: Check whether the IP set on the PC is in the same network segment (10.0.0.x) as the data board, if not, reset the IP of the PC to 10.0.0.3. If the error is cleared, then failure of incorrect IP address can be concluded; if
Set IP of the PC to 10.0.0.3
not, do step 2. Fail to 3
connect
2: D47 and D48 is off when power is connected,
network
network chip (U36) failure can be concluded, or else, do step 3.
2: D47 and D48 is on, poor connection of the network wire, or the wire is damaged.
The USB 5
interfaces cannot be used
1: Check if the kernel software version of MCU and the data board version are matched. View the kernel version information by click "Service-> Version Info. " on the analyzer screen. If result is not matched, upgrade the kernel to the correct version; or else, do step 2.
6-15
Replace
the
data board
Replug
or
replace
the
network wire
Upgrade
the
kernel to the correct version.
Hardware System
2: When power is connected, D70, D71, D72 and D73 are not all on, USB power chip or PCI-to-USB chip failure can be concluded, or else, do step 3. 3: When power is connected, D70, D71, D72 and D73 are all on but hot, the U85 and U86 failure can be concluded, or else, do step 4.
Replace
the
data board
Replace
the
data board
4: When power is connected, D70, D71, D72 and D73
Replug
are all on, replug the wire connected to the USB port. If
wire connected
the error is cleared, it can be concluded as an insecure
to
connection error; if not, do step 5.
port
5: When power is connected, D70, D71, D72 and D73 are all on, replace devices connected to the USB port (mouse, keyboard or USB). If the replaced ones can be used, then the device failure can be concluded; if not, do step 6.
the
the USB
Replace devices connected
to
the USB port
6: When power is connected, D70, D71, D72 and D73 are all on, test the USB port with a USB mouse or keyboard, if they can be used, but the USB printer cannot be used, check if the connection wire is marked with 1P/28AWG+2C/24AWG, USB SHIELDED HIGH SPEED, USB 2.0 VERSION. If not, replace the connection wire of the printer. If the error is cleared, the
Replace
the
connection wire of printer with a qualified one
connection wire failure can be concluded. 1: Test voltage of pin 1 or pin 4 of X5 with the multimeter, if the result is 0V, then X5 failure can be The clock 6
concluded; if not, do step 2.
Replace
the
data board
resets each time after
2: Cut off the power, test the voltage of capacitor C24
startup
with the buttery on by a multimater, if the result is <1.8V,
Replace
then insufficient quantity of the battery can be
button battery
the
concluded. 12V
analog
voltage 7
abnormal
1 Condition: the power wire is firmly connected. 2 If D20 is off, that indicates the data board failure; if not, do step 3. 3 Test voltage of the test point +12V or +12VM with the multimeter, if the result is outside [11.4~12.6]V, then
6-16
Replace data board
the
Hardware System data board failure can be concluded. 1 Condition: the power wire is firmly connected. 2 If D17 is off, that indicates the data board failure; if -12V analog 8
not, do step 3.
voltage
3 Test voltage of the test point -12V with the multimeter,
abnormal
if the result is outside [-11.4~-12.6]V, then data board
Replace
the
data board
failure can be concluded. or test voltage of the test point -12VM, if the result is outside [2.28~2.52]V, it also data board failure. 1 Condition: the power wire is firmly connected, and the input power is normal. 9
56V voltage abnormal
Replace 2 Test voltage of the test point +56V or +56VM with the
the
data board
multimeter, if the result is outside [47.6~64.4]V, then data board failure can be concluded. 1 Condition: the power wire is firmly connected, and the input +/-12V power is normal. Analog 5V 10
voltage abnormal
2 If D22 is off, that indicates the data board failure; if not, do step 3.
Replace
the
data board
3 Test voltage of the test point +5V with the multimeter, if the result is outside [4.75~5.25]V, then data board failure can be concluded. 1 Condition: the power wire is firmly connected, and the input +/-12V power is normal.
Analog -5V 11
voltage abnormal
2 If D21 is off, that indicates the data board failure; if not, do step 3.
Replace
the
data board
3 Test voltage of the test point -5V with the multimeter, if the result is outside [-4.75~-5.25]V, then data board failure can be concluded.
HGB blank 10
voltage
1. Condition: check if the power wire and the wire of
Replace
HGB sensor are firmly connected, and if +/-12V and
HGB lamp
+/-5V are under normal status. The error cannot be cleared by software operation and cleaning,
abnormal 2. See if the HGB lamp is off, if so, then the HGB lamp failure can be concluded; if not, proceed with the
6-17
the
Hardware System next step. 1. Test voltage of the HGB test point with the multimeter, if the result is outside [3.2V~4.9V], that indicates the ADC failure, the data board shall be replaced; if the result is outside [3.2V ~ 4.9V],
Replace
the
data board
proceed with the next step. 2. Enter the HGB gain calibration screen, modify HGB gain manually, see if the HGB background voltage changes accordingly. If the HGB background voltage changes, but is still lower than 3.2V when the gain has been modified to 255, that indicates
Replace
the
HGB lamp
aging of the HGB lamp; the lamp shall be replaced. Or else, proceed with the next step. 3. If HGB gain is modified, but HGB background voltage does not change, that indicates the data board failure.
Replace
the
data board
6.3 Drive Board 6.3.1 Introduction The drive board responds to the commands sent by the data board, controls the mechanical (e.g. motor transmission assembly) and fluid components (e.g. valves and pumps) of the analyzer and reports information like temperature and voltage to the data board. When controlling the mechanical components, the drive board detects the position of the components (by photocouplers, etc.), and when controlling the fluid components, it also monitors their pressure.
6.3.2 Structure The drive board consists of the power supply, central control module, detection module and power drive module.
6-18
Hardware System
Figure 6-9 Structure of the drive board 1 The power supply provides power to all the electrical components on the drive board, including the input power of the drive board and the power that has been passed through the power chip on the drive board. 2 The central control module communicates with the data board and schedules tasks. 3 The detection module collects information of temperature, pressure, voltage and fluid in tubing. 4 The power drive board drives the power components like motors, valves and pumps.
6.3.3 Sockets and Indicators
6-19
Hardware System Figure 6-10 View of the drive board sockets and indicators
6.3.4 Test Points and Calibration Resistance
Figure 6-11 Test points and calibration potentiometer
6.3.5 Adjustment and Testing After replacing the drive board or the rinse photocoupler assembly, the rinse photocoupler calibration potentiometer must be readjusted per the following procedure: 1 Log in with service access level or above, select "Setup""Service Setup""Photocoupler Calibration" to enter the screen; confirm whether the threshold needs to be modified. 2 Click "Start", the dialog box "Remove the Rinse tube from the container and press [OK] to continue." will pop up, do accordingly and then click "OK". 3 A progress bar will be displayed; after the progress ends, a dialog box will pop up. 4 Do as instructed by the dialog box. 1) Adjust rinse photocoupler calibration potentiometer VR1 (see Figure 6-11) manually until the rinse sensor calibration indicator D22 (see Figure 6-10) turns on. 2) Put the rinse tube back to the container (make sure there is rinse in the rinse container), click "OK" to close the dialog box. 3) Then click "Finish". 5 The rinse priming progress bar will be displayed; after the progress ends, the new background voltage, measured voltage and calibration status will be displayed; if the result is Fail, you need to re-perform calibration from step 1.If the result is Pass, that means the calibration succeeded.
6-20
Hardware System
6.3.6 Troubleshooting 1) Checks before troubleshooting Before troubleshooting the drive board, you should first check if the wires are firmly connected, if they are connected to the sockets of the same No., and if the wires are damaged. When you suspect that drive board failure occurs, check if the indicators are under normal status per the following table. Table 6-6 Status of drive board indicators Indicator
No.
Normal
Abnormal
Description If the indicator is off, that means the 5V power supply is abnormal. Cut off the power of the analyzer, test the resistance of the 5V
5V indicator
fuse (see Figure 6-11) with the multimeter, if D8
On
Off
the result is over 1 ohm, that indicates the 5V fuse is damaged and the drive board needs to be replaced; if not, check if the 5V output voltage of the power board is within the range [4.75V,5.25V]. If the indicator is off ,that means the 3.3V power supply is abnormal, which can be
3.3V indicator
caused by the abnormal 5V power supply or D11
On
Off
damaged drive board (you can determine which the case is by observing the 5V indicator or testing the voltage between VCC and GND). If the indicator is off, that means the 12V power supply is abnormal, which will result in the breakdown of all valves and pumps. Cut off the power of the analyzer, test the
12V indicator
resistance of the 12V fuse (see Figure 6-1) D10
On
Off
with the multimeter, if the result is over 1 ohm, that indicates the 12V fuse is damaged and the drive board needs to be replaced; if not, check if the 12V output voltage of the power board is within the range [11.4V, 12.6V].
24V indicator
D9
On
If the indicator is off, that means the 24V
Off
power supply is abnormal, which will result in
6-21
Hardware System the breakdown of all motors. Cut off the power of the analyzer, test the resistance of the 24V fuse (see Figure 6-11) with the multimeter, if the result is over 1 ohm, that indicates the 24V fuse is damaged and the drive board needs to be replaced; if not, check if the 24V output voltage of the power board is within the range [22V,30V]. If the indicator does not flicker, that means the MCU is not working normally. First check if the 3.3V power is under normal status (voltage range [3.15V,3.45V]) by observing MCU indicator
D49
Flickers
Does not
every 1s
flicker
the 3.3V power indicator or testing the voltage between VDD and GND, if error of the 3.3V power supply is found, replace the drive board or upgrade the MCU program of the drive board per the upgrade instruction. If the indicator still does not flicker after the upgrade, the drive board must be replaced. If the indicator does not flicker, that means the FPGA is not working normally. First check if the 3.3V power supply is normal (voltage range [3.15V,3.45V]) by observing the 3.3V indicator or testing the voltage between VDD and GND. And check if the 1.5V power
FPGA indicator
D51
Flickers
Does not
supply is normal (voltage range [1.45V,
every 1s
flicker
1.55V]) by testing the voltage between 1V5 and GND. If error of the power supplies is found, replace the drive board or upgrade the FPGA program of the drive board per the upgrade instruction. If the indicator still does not flicker after the upgrade, the drive board must be replaced.
If all the indicators are confirmed to be ok, check if the MCU and FPGA versions are correct on the software screen (Click the menu option"Service" "Version Info."); if yes, troubleshoot the error as instructed in the following section. 2) Troubleshooting You can roughly locate the error by the alarm, then accurately locate the error by its type and dispose it, see Table 6-7. Table 6-7 Troubleshooting methods No.
Type
Description
Troubleshooting Methods 6-22
Hardware System
1 Check if the power supply of the board is normal; 2 Check if the wires of motors and photocouplers of all channels are firmly connected, if they are connected to the sockets of the same No., and if the wires are damaged. This type of
3 After completing step 1 and 2, click "Clear Error"
errors include
or perform self-test on the software screen to see if
but are not limited to:
Check
if
the
luminous
surface
of
the
photocoupler is covered by dust or fluid spills, if so
breakdown;
clean and reinstall the photocoupler to see if the
working, but motor or photocoupler Motors and
4
a Motor
b Motor is
1
the error can be cleared.
error is reported;
photocouplers
error can be cleared. If the error persists, replace the photocoupler. 5 If the error cannot be cleared by replacing the photocoupler, replace the drive board. 6 If the error persists, replace the motor of the corresponding channel. 7 If the above step fails to clear the error, it may be caused by the failure of mechanical components (e.g. the friction force is too great), you should handle it as a mechanical error. 1 Check if wires of the motors are firmly connected and if they are damaged, if so, replug or replace the wires when power is off. 2 Check if the fixing screws of the mechanical
Abnormal
assembly are loose, if so, tighten the screws.
sounding of motors
3 If the above problems are excluded, the error may be caused by drive board failure, replace the drive board. 4 If step 3 fails to clear the error, replace the motor assembly. 1 First check if the valve can be open and closed
Breakdown of 2
Valves
valves is suspected
normally (you can hear a clatter) at the self-test screen; if yes, that means the valve drive is ok, you should consider the error as a fluidic error. 2 If the valves cannot be open and closed normally, check if its wire is firmly connected or damaged. If 6-23
Hardware System yes, replug or replace the wire. 3 If step 2 cannot clear the error, connect the wire of another valve to the valve, then check if the error lies in the valve drive circuit or the valve itself at the self-test screen (if failure of valve 2 is suspected, connect the wire of valve 3 to valve 2, then open and close valve 3 at the self-test screen, if it can be open and closed normally, that means the drive board has been damaged and shall be replaced; otherwise valve 2 is damaged and shall be replaced). 1 Check if the pumps can work normally at the self-test screen, if yes, the error shall be a Abnormal
3
Pumps
considered as a gas path error.
pressure is
2 If the valves cannot work normally, check if its
reported
wire is firmly connected or damaged. If yes, replug
b Breakdown of pumps
or replace the wire. 3 If the error cannot be cleared by step 2, replace the drive board. 4 If the error persists, replace the pump. 1 Check if the indicators of the data board and drive board are under normal status, if not, replace the boards. 2 Check if the wire between the data board and
4
Communication
Communication
drive board is firmly connected, if not, replug the
error is reported
wire. 3 If the error cannot be cleared, replace the wire. 4 If the error persists, replace the drive board and data board in turn. 1 Perform rinse photocoupler calibration to see if the error can be cleared. If the calibration cannot be perform successfully, replace the drive board
5
Rinse photocoupler
Rinse
and then recalibrate.
photocoupler error is reported
2 Disassemble the rinse photocoupler assembly, check if the photocoupler is cover by fluid spills or dust, if yes, clean the photocoupler. 3 If the error cannot be cleared, replace the rinse 6-24
Hardware System photocoupler assembly. 4 If the error persists, it may be caused by aging of the rinse tube. 1 Check if the waste wire is loose or damaged, if 6
Waste sensor
Incorrect alarm
yes, pull off and clean the wire and then replug it,
of waste status
or replace the waste wire. 2 If no, replace the waste cap assembly.
a The aspirate
1 Check if the wires of the aspirate key and the
key does not
sample compartment connection board are loose
respond when being pressed. 7
Micro-switch
or damaged, if yes, replug or replace the wires. 2 if the error cannot be cleared, disassemble the
b The sample
switch of the aspirate key and the sample
compartment
compartment connection board to see if they are
door cannot be
covered by fluid spills. If yes, clean and then
closed.
reinstall them.
6.4 Power Board 6.4.1 Introduction In the BC-3600 Auto Hematology Analyzer, the power board provides 6 groups of stable power output, including D5V, A+12V, A-12V, AC120V, P12V, P24V. Section 6.4 is the servicing and troubleshooting guideline of the power board.
6.4.2 Structure Function The functional diagram of the power system is as follows:
6-25
Hardware System
Figure 6-12Functional diagram of the power board
Description: The power board works under the 100-240V(±10%) AC input voltage 50/60Hz(±2Hz).Once the AC power switch is on, all the circuits start to work, the D5V, A+12V, A-12V, AC130V, P12V, and P24V all output. The load of each circuit is listed in the following table: Table 6-8 Properties of output voltage Voltage
Load
regulatio
regulatio
n factor
n factor
5A
±1%
0.3A
0.3A
0.01A
0.2A
0.2A
2A
Minimum
Normal
Peak
Load
Load
Load
D5V
1.5A
3A
A+12V
0.05A
A-12V P12V
Voltage
Range of
Ripple&
output voltage
Noise
±3%
4.85~5.25V
100mV
±1%
±3%
11. 5~12. 5V
100mV
0.2A
±1%
±3%
-11.5~-12.5V
100mV
4A
±1%
±3%
11.5~12.5V
150mV
6-26
Hardware System
P24V
0A
0.3A
1.5A
±1%
±10%
22~30V
150mV
AC120V
0mA
0mA
60mA
/
/
110~140V(RMS)
/
11W
53W
123W
Output Power
Peak load means the Peak Load current of P12V and P24V in the cycle of 60S is no more than 1S. D5V has a single ground, A±12V share one ground, P12V and P24V share one ground; AC120V shall be alternate current(square wave), frequency is 50Hz+/-10Hz. Definition of Interfaces The power board has 6 outgoing interfaces, 4 of them (J1, J2, J3 and J4) are connected by sockets; The AC input wires L and N are connected to external sockets, PCB No.s are L and N; the inverse board is connected to the power board by a socket, PCB No. is PCBA1.See the following figure for the position of each interface on the board.
Figure 6-13Mounting of the power board See the following table for the function of each interface: Figure 6-9 Input AC wires Definition L, live wire end of the power N, neutral wire end of the power
Table 6-10Interface socket PCBA of power board and small board PIN
Definition 6-27
Hardware System Connected to the positive end of the P24V
1/2#
output voltage Connected to the positive end of the P12V
3/4#
output voltage
5/6/7/8#
Connected to PGND end
9/10#
Connected to AC1 end
11/12#
NC
13/14#
Connected to AC2 end
Table 6-11 Definition of output interface sockets Name
Socket
Socket Model
No.
D5V
M32-032005-00, HEADER WTB 3.96mm DIP1*3SIDE VHseries
J1
P12V, P24V
M32-069002-00, HEADER WTB 4.2mm DIP2*3SIDE POWER
J2
A+12V, A-12V
M39-000139---, HEADER WTB 4.14MM DIP3SIDE
J3
AC120V
M33-022002-01, HEADER WTB 3.96mm DIP1*2SIDE
J4
6.4.3 Adjustment and Testing The following test points are important in the servicing process: Table 6-12Definition of debug and test points No.
Location
Function
Reference Value
1
C123.+
PFC output voltage
390±20V
2
U12.9
PFC chip reference voltage output
7.5V
3
C107.+
VCC voltage
17V~22.5V
4
C19
VDD voltage
12±1V
5
U1.8
Reference voltage of U1
5V
6
C111.+
Output voltage and ripple voltage of
5±0.5V
D5V 7
C117.+
A+12V output
12±0.5V
8
C115.-
A-12V output
-12±0.5V
6-28
Hardware System
9
C121.+
U3 power supply voltage
12±1V
10
U3.14
U3 reference voltage
5V
11
C119.+
P24V output voltage and ripple voltage
22~27V
12
C120.+
P12V output voltage and ripple voltage
12±0.5V
6.4.4 Replacing and Wiring Methods Purpose: the power board is a critical component of the analyzer, it must be replaced and serviced in time when related errors are found to ensure the proper running of the analyzer. Replace the power board per the following procedure. Tools: 107 cross-headed screwdriver, multimeter Disassembling: 1 power off the analyzer and pull out the AC wire. 2、 Take out the power supply assembly from the chassis of the analyzer. 3 Disassemble the power supply casing per the instructions in the operator's manual, remove the 4 fixing screws of the power board and take out the board from the power supply casing.
When servicing the boards, wear antistatic gloves.
When disassembling and installing the boards, cut off the power and pull out the power wire.
Installing: Do the above steps in reverse order Verification: 1 Check if the ground wire of AC input socket on the casing is securely connected to the conductive part of the analyzer chassis. 7、 Connect the power wire and switch on the AC switch, the analyzer enters initializing status and the indicators on the board turn on.
Make sure the power supply assembly and the analyzer chassis are fastened by screws.
The disassembling operation must be done after the power board and the surrounded parts cool down.
6.4.5 Troubleshooting The errors of the power board can be troubleshooted per the following procedure.
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Hardware System
Figure 6-14 Troubleshooting errors of the power board
6.5 USB Interface Board 6.5.1 Introduction The USB interface board is extended to the front cover of the analyzer by extension wire to provide users with a USB interface. The USB interface board does not need to be adjusted.
6-30
Hardware System
Figure 6-15 USB interface board
6.5.2 Troubleshooting When the USB interface on the front cover cannot be used, do as follows: 1、Check if the data board is working properly, if not, handle the problem of the data board first. 2、Check if the wire connecting the USB interface board and the data board is loose or damaged, if yes, replug or replace the wire; if not, check if the USB interface board is cover by fluid spills, replace the board if so. 3、If the problems mentioned in the above step are excluded, replace the data board.
6.6 Touchscreen Control Board 6.6.1 Introduction Touchscreen control board is the interface of the touchscreen to the data board, it converts the touch operations of users to signals recognizable to the data board. The touchscreen control board does not need to be adjusted.
6-31
Hardware System Figure 6-16 Touchscreen Control Board
6.6.2 Troubleshooting No.
Phenomenon
Possible Cause
Solution 1、 、 Check if the data board is working properly, if not, handle the problem of the data board first. of
2 、 Check if the wire connecting the
touchscreen control
touchscreen control board and the data
board/Failure
board is loose or damaged; if it is loose,
Failure The 1
touchscreen
does not respond to touch operation
of
touchscreen/the
replug the wire, if it is damaged, replace
connection wire is
the whole front cover signal wire.
loose
3、 、If the above problems are excluded, replace the touchscreen control board. 4、 、If the error cannot be cleared, replace the touchscreen.
The wire connecting
1、 、 Check if there is any crack on the
touchscreen,
the
touchscreen
touchscreen,
cursor
can
control board and
touchscreen.
move
the touchscreen is
When the the 2
pressing
only
horizontally or
loose/the touchscreen
vertically
The cursor cannot 3
move to a certain area
if
yes,
replace
the
2、 、Replug the wire
is
cracked
The touchscreen is
1、 、Perform touchscreen calibration.
not
2 If the error cannot be cleaned, check if
calibrated/the
touchscreen
is
cracked
the touchscreen is cracked; if so, replace the touchscreen.
6.7 Volumetric Board 6.7.1 Introduction The volumetric board detects the pressure of the pressure and vacuum chambers and measures fluid volume. The board has been calibrated in factory, so you do not need to calibrate it before using it.
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Hardware System
Figure 6-17 Volumetric Board
6.7.2 Troubleshooting No.
Type
Description
Troubleshooting Methods 1、 、Click "Service" "System Test", and then click the "WBC Test Time" and "RBC Test Time" buttons
Including
Abnormal 1
detection of fluid
but
on the screen to see if the error can be cleared.
not limited to the
2、 、If the error cannot be cleared, check if the data
following errors:
board is working properly; if not, resolve the problem
1) )WBC clog 2) )WBC bubbles 3) )RBC clog 4) )RBC bubbles
of data board first. 3、 、If data board error is excluded, check if the wires connecting the volumetric board, the drive board and the data board are loose or damaged; if the wires are loose, replug them; if they are damaged, replace them. 3、 、Check if there are bubbles in the WBC or RBC tubes during analyzing process; if yes, clear the error 6-33
Hardware System first. 4、 、Check if the fluid in the WBC or RBC tube is not flowing or is flowing slowly; if yes, clear the error first. 5、 、The analysis starting indicator shall turn on when fluid reaches the analysis starting photocoupler, and when fluid reaches the analysis ending photocoupler, the analysis ending indicator shall turn on, then both indicators turn off at the same time. If you did see the above situation, replace the volumetric board. 1、 、Click "Service" "System Test", and then click the Vacuum Of VC, Pressure Of VC and Pressure Of PC buttons on the screen to see if the error can be cleared. 2、 、If the error cannot be cleared, check if the data board is working properly; if not, resolve the problem of data board first. 1) 2
Pressure
Abnormal
buildup fails
pressure
2)
3、 、Check if the detection channels of the vacuum and pressure chambers are connected reversely; if yes,
Vacuum
switch the two channels.
buildup fails 4 、 If the data board and detection channels connection errors are excluded, check if the wires connecting the volumetric board, the drive board and the data board are loose or damaged; if the wires are loose, replug them; if they are damaged, replace them. 5、 、If the wires are ok, replace the volumetric board.
6.8 Sample Compartment Connection Board 6.8.1 Introduction The sample compartment connection board is in the closed tube sampling assembly of closed tube analyzers, it detects the open/close status of the compartment door and the type of tube holder adapters. The sample compartment connection board does not need to be adjusted.
6-34
Hardware System
Figure 6-18 -Sample compartment connection board
6.8.2 Troubleshooting The phenomenon of sample compartment connection board error is the analyzer does not respond to closing operation. Clear the error per the following procedure: 1 Check if the drive board is working properly, if not, handle the problem of the drive board first. 2 Check if the wire of the sample compartment connection board (including J8 of drive board, J1 and the transfer socket of sample compartment connection board) is loose or damaged, if so, replug or replace the wire. 3 If the problem mentioned in step 1 can be excluded, disassemble the board, check if there are fluid spills in the switch; if yes, replace the board. 4 If not, replace the drive board.
6.9 Indicator Board 6.9.1 Introduction The indicator board tells users the status of analyzer through sound and light.
Figure 6-19 Indicator board
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Hardware System
6.9.2 Structure The indicator board consists of indicators of three colors- red, yellow and green, their control circuits and the drive circuit of buzzer. The indicator board does not need to be adjusted.
6.9.3 Troubleshooting No.
Type
Description
Troubleshooting Methods There are 7 LEDs for an indicator of one color. If the indicator is dim, that means some of the 7 LEDs are damaged. Disassemble the indicator board, see if the
1
The indicator is
7 LEDs are all on; if not, the board is damaged and
dim
shall be replaced; if yes, test the voltage of pin 6 and
Indicator
7 of J1 on the board with the multimter, if the voltage is lower than 4.5V, check if the 5V power supply of the data board is normal. The
indicator
cannot turn on The buzzer does not beep 2
Buzzer
when the analyzer sends alarm
1 Check if the data board is working properly, if not, handle the problem of the data board first. 2 Check if the wire of the board is loose or damaged; if it is loose, replug it; if it is damaged, replace the whole front cover signal wire. 3 If the problem of the wire is excluded, replace the indicator board.
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7
Servicing
7.1 General You can service the BC-3600 and BC-3300 as per Section 7.2 –7.21. For the repairing with verification, you must follow the procedures strictly to verify the maintenance.
7-1
Servicing
7.2 Disassembling the Panels 7.2.1 Opening the Front Panel Assembly Purpose:Bath Assembly and Sampling Assembly are located behind the Front Panel, Screen Assembly and Recorder are located on the Front Panel, to maintenance or disassemble the parts mentioned above, need to follow the procedures to open the Front Panel Assembly. Tools:N/A Removal: 1 Power off the analyzer and unplug the power cord from the wall outlet; 2 Resume the Sample compartment to work place (If the Sample compartment is already on workplace, skip this step; for open vial configuration, also skip this step); 3 Pull the slot on right side(see Figure7-1) and open the Front Panel.
Figure 7-1 Opening the Front Panel Assembly
Make sure the door of sample compartment is closed when opening the Front Panel, or it may cause damage on the sample compartment and the Front Panel.
Installation: Install the Front Panel according to the steps stated above in reverse order. Verification: Pull the Front Panel to check whether it’s locked tightly; Power on the analyzer and verify your replacement.
7-2
Servicing
7.2.2 Removing the Left Door Purpose: Follow the procedure to remove the left door to disassemble the hardware parts inside the analyzer Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Open the Front Panel as per 7.2.1. For ease of operation, the opening angle should be no less than 60°; 3. Use the 107 screwdriver to unscrew the 2 cross-headed screws as per Figure 7-2; 4. Use the 107 screwdriver to unscrew the 3 cross-headed screws as per Figure 7-3, and then remove the Left door.;
Figure 7-2 Inside of the left door
Figure 7-3 Outside of the left door
Installation: Install the Left Door according to the steps stated above in reverse order. Verification: Pull the Left Door to check whether it’s locked tightly.
7.2.3 Opening the Right Door Purpose: Follow the procedures to open the right door to disassemble the fluidic parts inside the right side of the analyzer as needed. Tools: Flat-headed screwdriver Removal: Insert the flat-headed screwdriver into the slot of the right door lock, and turn 90° counterclockwise and open the door(see Figure 7-4).
7-3
Servicing
Figure 7-4 Opening the Right Door Installation: Install the Right Door according to the steps stated above in reverse order. Verification: Pull the Right Door to check whether it’s locked tightly.
7.2.4 Removing the Top Cover Purpose: Follow the procedures to remove the top cover to disassemble the Pressure Chamber, Power supply assembly and cables. Tools: 107 cross-headed screwdriver Removal: Power off the analyzer and unplug the power cord from the wall outlet; Use the 107 screwdriver to unscrew the 3cross-headed screws on the back of analyzer as per Figure 7-5; Remove the Top Cover.
Figure 7-5 Removing the Top Cover
7-4
Servicing Installation: Install the Top Cover according to the steps stated above in reverse order. Verification: Check Whether the Top Cover is installed properly.
7.2.5 Removing the Front Panel Assembly Purpose: Follow the procedures to remove the Front Panel Assembly, for the ease and space of repairing or replacing the USB port inside. Tools: Nipper pliers, 107 cross-headed screwdriver Removal: 1.
Turn off the analyzer and unplug the power cord from the wall outlet;
2.
Open the Front Panel as per 7.2.1, unplug all cables connected between the Front Panel and the Main unit;
3.
Open the Left Door as per 7.2.2;
4.
Use a sharp nose pliers to straighten the forelock on the hinge and then pull it out;
5.
Lift the Front Panel Assembly for about 5mm, and then take out the assembly.
7-5
Servicing
Figure 7-6 Removing the Front Panel Installation: Install the Front Panel Assembly according to the steps stated above in reverse order. Verification: 1. Check whether all components are installed and fixed in place; 2. Check whether the left and right side doors are locked tightly; 3. Check whether the front panel is locked tightly; 4. Power on the analyzer and verify your replacement.
7.3 Replacing
the
Hardware
parts
and
Cable
connection 7.3.1 Replacing the Data board Purpose: Follow the procedures to replace the data board as needed. Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Open the left door as per 7.2.2; 3. Unplug all cables on the power driver board; 4. Use the 107 cross-headed screwdriver to unscrew the 7 cross-headed screw driver on power driver board(see Figure 7.7); 5. Take out the data board.
7-6
Servicing
Figure 7-7 Removing the Data Board Installation: Install the Data board according to the steps stated above in reverse order Verification: 1. Check whether the cables are connected correctly; 2. Power on the analyzer and verify the power and working indicators on the data board; 3. Execute Background test. If there is any error message, please do the troubleshooting accordingly.
7.3.2 Replacing the Power Driver board Purpose: Follow the procedures to replace the Power Driver board as needed. Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Open the Left Door as per 7.2.2; 3. Unplug the cables on the Power Driver board; 4. Use the 107 cross-headed screwdriver to unscrew the 6 cross-headed screws on the Power driver board(see Figure 7-8); 5. Take out the Power Driver board.
7-7
Servicing
Figure 7-8 Removing the Power Driver Board Installation: Install the Power Driver board according to the steps stated above in reverse order Verification: 1. Check whether the cables are connected correctly; 2. Power on the analyzer and verify the power and working indicators on the Power Driver board; 3. Execute Background test. If there is any error message, please do the troubleshooting accordingly.
7.3.3 Replacing the Touch screen control board Purpose: Follow the procedures to replace the Touch screen control board as needed. Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Open the Front panel as per 7.2.1; 3. Use the 107 cross-headed screwdriver to unscrew the 2 screws fixing the shielding cover; 4. Use the 107 cross-headed screwdriver to unscrew the 2 screws fixing the touch screen control board; 5. Take out the Touch screen control board.
7-8
Servicing
Figure 7-9 Removing the Touch Screen Control Board Installation: Install the touch screen control board according to the steps stated above in reverse order Verification: 1. Check whether the cables are connected correctly; 2. Power on the analyzer and verify the replacement.
7.3.4 Replacing the Inverter Purpose: When the Inverter is broken, display will have black screen trouble. In this case, please follow the procedures to replace the Inverter. Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Open the Front Panel as per 7.2.1; 3. Use the 107 cross-headed screwdriver to unscrew the 2 screws fixing the shielding cover, and then take out shielding cover; 4. Use the 107 cross-headed screwdriver to unscrew the 2 screws fixing the Inverter, remove and keep the screws with gaskets; 5. Take out the Inverter.
7-9
Servicing
Figure 7-10 Removing the Inverter Installation: Install the Inverter according to the steps stated above in reverse order Verification: 1. Check whether the cables are connected correctly; 2. Check whether the screws are fastened tightly; 3. Power on the analyzer and verify your replacement.
7.3.5 Replacing the USB Interface Board Purpose: Follow the procedures to replace the USB Interface board as needed. Tools: 107 cross-headed screwdriver, nipper pliers Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Remove the Front Panel as per 7.2.5; 3. Use the 107 cross-headed screwdriver to unscrew the 2 screws fixing the shielding cover. Remove the Shielding cover; 4. Use the 107 cross-headed screwdriver to unscrew the 2 screws fixing the Inverter and the grounding screw; 5. Take out the USB Interface board together with USB cable.
7-10
Servicing
Figure 7-11 Removing the USB Interface Board Installation: Install the USB Interface board according to the steps stated above in reverse order Verification: 1. Check whether the cable is connected correctly; 2. Connect the mouse with the USB interface to check whether the cursor on the display is moving normally. If not, please do the troubleshooting needed.
7.3.6 Replacing the Volumetric Board Purpose: Follow the procedures to replace the Volumetric Board. Tools: 107 cross-headed screwdriver Removal: 1. Empty the fluidic system in the software. Power off the analyzer and unplug the power cord from the wall outlet; 2. Open the Front Panel as per 7,2,1; 3. Use the 107 cross-headed screwdriver to unscrew the 2 screws fixing the shielding cover, and take out the shielding cover; 4. Use the 107 cross-headed screwdriver to unscrew the 2 screws fixing the Volumetric board; 5. Take out the Volumetric board.
7-11
Servicing
Figure 7-12 Removing the Volumetric Board Installation: Install the Volumetric board according to the steps stated above in reverse order Verification: 1. Check whether the cable connection between the Volumetric board and power
7-12
Servicing driver board is correct. Check Whether the Pressure and Vacuum sensor are connected correctly; 2. Turn on the analyzer. Check whether the background is within range, if not, please do the troubleshooting needed.
7.3.7 Replacing the Sample compartment connection board Purpose: Follow the procedures to replace the Sample compartment connection board. Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Open the Front Panel as per 7.2.1; 3. Take out the Tube holder adapter, and turn the Sample Compartment upside down(see Figure 7-13); 4. Use the 107 cross headed screwdriver to unscrew the 2 M3x8 Cross-recessed panhead screws fixing the cover(see Figure 7-14); 5. Use the 107 cross headed screwdriver to unscrew the 4 M3x8 Cross-recessed panhead screws fixing the Sample compartment connection board, and unplug the cables connected on the board. Take out the Sample compartment connection board(see Figure 7-15).
Figure 7-13 Preparation before disassembling
7-13
Servicing
Figure 7-14 Disassembling cover of the micro-switch 1 -- Cover of micro-switch
2-- Cross-recessed panhead screw M3X8
Figure 7-15 Disassembling PCBA of sample compartment connection board 1 -- PCBA of Sample compartment connection board
2 -- Cross-recessed panhead screw M3X8
Make sure the sample probe is always located on the upper position during 7-14
Servicing the disassembly.
Installation: Install the Sample compartment connection board according to the steps stated above in reverse order Verification: 1. Check whether the cables are connected correctly between the Sample compartment connection board and the Power driver board; 2. Turn on the analyzer and check whether the sample compartment is working normally.
7.3.8 Replacing the Indicator board Purpose: Follow the procedures to replace the Indicator board Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Open the Front Panel as per 7.2.1; 3. Use the 107 cross-headed screwdriver to unscrew the 2 screws fixing the Shielding cover and remove it; 4. Use the 107 cross-headed screwdriver to unscrew the 2 screws fixing the Indicator board; 5. Take out the Indicator board with cable.
7-15
Servicing Figure 7-16 Removing the Indicator Board Installation: Install the indicator board according to the steps stated above in reverse order. Verification: 1.
Check whether the cable connection between the Indicator board and the Data board is correct;
2.
Turn on the analyzer. Check whether the indicator can show red, yellow and green colors correctly when error message displayed, and if the buzzer is working normally.
7.4 Replacing the Power Supply Assembly Purpose: Follow the procedures to replace the Power Supply Assembly as needed. Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Unplug USB cable, network cable and serial cable connectors on the power fixing board; 3. Open the left side door as per 7.2.2; Remove the Top Cover as per 7.2.4; 4. Use 107 cross-headed screwdriver to unscrew the grounding screw of Power supply assembly, unplug all the cable connection. Insert all the cables into the analyzer; 5. Use 107 cross-headed screwdriver to unscrew the 4 cross-headed sunk screws on the power fixing board; 6. Take out the Power Supply Assembly.
7-16
Servicing Figure 7-17 Removing the Power Supply Assembly Installation: Verification: 1. Check whether the power connections meet the requirement; 2. Check whether the indicators on the data board and power driver board are on good condition; 3. Check whether the monitoring voltages are within range in Self-test screen.
7.5 Replacing the Display Assembly Purpose: Follow the procedures to replace the Display assembly as needed. Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Open the Front Panel as per 7.2.1; 3. Remove the touch screen control board and the shielding cover as per 7.3.3; 4. Use 107 cross-headed screwdriver to loosen the grounding screw(yellow and green color) on the assembly; 5. Open the Left side door as per 7.2.2; 6. Remove the Top cover as per 7.2.4; 7. Disconnect the cables connected with the Display assembly from the Data Board; 8. Use 107 cross-headed screwdriver to unscrew the fixing screws; 9. Take out the Display Assembly.
7-17
Servicing Figure 7-18 Removing the Displaying Assembly Installation: Install the Display assembly according the steps stated above in reverse order. Verification: 1. Check whether all components are installed and fixed in place; Check whether the cables are connected correctly; 2. Start up the analyzer and check the displaying of the screen.
7.6 Replacing the Touch Screen Purpose: Follow the procedures to replace the Touch Screen as needed Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Remove the Display assembly as per the step2,3,8,9 of chapter 7.5. Note you do not have to disconnect the cable; 3. Use 107 cross-headed screwdriver to loosen the plates fixing the Touch Screen; 4. Take out the Touch Screen.
Figure 7-19 Removing the Touch Screen Installation: Install the Touch Screen according the step1-3 stated above in reverse order. Verification: 1. Check whether all components are installed and fixed in place; Check whether 7-18
Servicing the cables are connected correctly; 2. Start up the analyzer and check the touching and displaying of the screen.
7.7 Replacing the Recorder Assembly Purpose: Follow the procedures to replace the Recorder Assembly as needed Tools: 107 cross-headed screwdriver Removal: 1. Power off the analyzer and unplug the power cord from the wall outlet; 2. Open the Front Panel as per chapter 7.2.1; 3. Unplug all cable connection of the recorder include the grounding wire; 4. Open the door of the recorder; 5. Use the 107 cross-headed screwdriver to unscrew the 2 screws inside; 6. Pull the pins on both sides manually until the recorder is loose, and then take out the recorder. Or open the cover, press the buckle (the grayed area) on the left of the recorder at full tilt and then pull it out with one hand, when the buckle leaves its original location, take off the recorder with another hand from outside of the front cover.
7-19
Servicing
Figure 7-20 Removing the Recorder Installation: Install the Recorder according the steps stated above in reverse order. Verification: Start up the analyzer and check the printing of the recorder.
7.8 Replacing the valve, pumps, and other liquid system parts 7.8.1 Replacing the valve Purpose: Electromagnetic valve is used to control the liquid flow inside the tube, or control the access way between different tubes, the failure modes usually are clogged or rusty. In case of malfunction, please replace it in time. Following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the right side panel (as per section 7.2.3), Disassemble the lyse bottle and cap assembly. 4. Open the top panel(as per section 7.2.4); 5. Unplug the all the tubes on the valve; 6. Disconnect the cable connector between the fluidic diaphragm and electric diaphragm; 7. As following Figure shows, Use the 107 cross-headed screwdriver to remove the two M3 panhead screws 8. Take out the valve assembly.
7-20
Servicing
Please empty the liquid system before replacing the valve, otherwise the reagents
might
leak
out
of
instrument
and
cause
the
biological
contamination.
Figure 7-21 Electromagnetic valve disassembly
Installation: The installation procedures are the reverse order of step 1~8, during the installation, the direction of the valve month should be in accordance with previous one. Verification: 1. Check if the parts are assembled properly; 2. Make sure the tube connection and power cable connection are correct; 3. Turn on the instrument, and press “Menu” in counting screen to pop-up the system menu, choose “service”-> “Valve test” to test the related valve.
7.8.2 Replacing the waste pump assembly Purpose: Waste pump provides the power to the draining waste and establishing the vacuum, it runs longer and more frequently, is a rapid wear part. In case of malfunction, please replace it in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the right side panel (as per section 7.2.3), Disassemble the lyse bottle and cap 7-21
Servicing
assembly. 4. Open the top panel(as per section 7.2.4); 5. Unplug the all the tubes connected with the waste pump, please don’t disassemble the fluid pump protecting plate; 6. Disconnect the cable connector between the fluidic diaphragm and electric diaphragm; 7. As following Figure shows, Use the 107 cross-headed screwdriver to remove the four M3 sunk screws and four spacers. 8. Take out the waste pump assembly.
Please empty the liquid system before replacing the pump assembly, otherwise the reagents might leak out of instrument and cause the biological contamination.
Figure 7-22 Waste pump disassembly
Installation: The installation procedures are the reverse order of step 1~8, during the installation, the direction of the pump month should be in accordance with previous one. Verification: 1. Check if the parts are assembled properly or not; 2. Make sure the tube connection and power cable connection are correct; 3. Turn on the instrument, and press “Menu” in counting screen to pop-up the system menu, choose “service”-> “system test” to access the “Vacuum Test” to test the vacuum.
7.8.3 Replacing the pressure pump and chamber assembly Purpose: Pressure pump and chamber is used to establish and store the pressure, when they’re broken, the pressure will be abnormal, thereby to influence the function of bubble mixing and flushing. In case of malfunction, please replace the 7-22
Servicing
assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the right side panel(as per section 7.2.3), Disassemble the lyse bottle and cap assembly. 4. Open the top panel(as per section 7.2.4); 5. Open the front panel assembly(as per section 7.2.1); 6. Unplug the all the liquid tubes and electric cable connected with the pressure pump and chamber assembly; 7. As following Figure shows. Use the 107 cross-headed screwdriver to remove the two M3 sunk screws fixing the assembly, take out the assembly from the back of front panel; 8. As Figure 7-23 shows. Use the 107 cross-headed screwdriver to remove the four M3 pan head screws fixing the pump, cut the tie fixed the pump, take out the pump assembly; 9. As Figure 7-23 shows. Use the 107 cross-headed screwdriver to remove the two M3 pan head screws fixing the chamber, remove the hoop and pad, then take out the chamber;
7-23
Servicing
Figure e 7-23 Pressure pump and chamber disassembly
Installation: The installation procedures are the reverse order of step 1~9, during the installation, the direction of the pump and chamber assembly and connection should be in accordance with previous one. Verification: 1. Check if the parts are assembled properly or not; 2. Make sure the tube connection and power cable connection are correct; 3. Turn on the instrument, and press “Menu” in counting screen to pop-up the system menu, choose “service”-> “system test” to access the “Pressure Test” to test the pressure.
7-24
Servicing
7.8.4 Replacing the vacuum chamber assembly Purpose: Vacuum chamber assembly is used to store the negative pressure for counting and cleaning. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the right side panel(as per section 7.2.3), Disassemble the lyse bottle and cap assembly. 4. Unplug the all the liquid tubes connected with the vacuum chamber assembly; 5. As following Figure shows. Use the 107 cross-headed screwdriver to remove the two M3 pan head screws fixing the assembly, remove the hoop and pad one by one, then take out the chamber;
Figure 7-24 Vacuum chamber disassembly
1 ―――Vacuum Chamber Assembly
2 ―――Pad
3 ―――Hoop
4―――M3x8 pan head screw
Installation: The installation procedures are the reverse order of step 1~5, during the installation, the direction of the pump and chamber assembly and connection should be in accordance with previous one. Verification: 7-25
Servicing
1. Check if the parts are assembled properly or not; 2. Make sure the tube connection and power cable connection are correct; 3. Turn on the instrument, and press “Menu” in counting screen to pop-up the system menu, choose “service”-> “system test” to access the “Vacuum Test” to test the vacuum.
7.8.5 Replacing the volumetric tube assembly Purpose: Volumetric tube is a key part, which is used to measure the liquid volume during testing. If there are impurities or other particles, they’ll give bad influence to test result. Furthermore, if the optical sensor in the assembly is down, it’ll also influence the regular service. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: The detail procedures of disassembly, please refer to Section 7.3.5 Installation: The installation procedures are the reverse order of disassembly procedures, during the installation, please keep the top of the tube is the same with previous one, and arrange the position of tubing properly. Verification: 1. Check if the parts are assembled properly or not; 2. Make sure the tube connection and power cable connection are correct; 3. Turn on the instrument, disassemble the shielding cover of the volumetric board, and then do background test, observe the liquid flow inside of the volumetric tube, meanwhile care for the counting time. If the volumetric sensor is normal, the instrument will return back to counting screen after counting, otherwise it’ll give alarm.
7.8.6 Replacing the rinse detecting assembly Purpose: This part is used to detect the volume of rinse. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the right side panel (as per section 7.2.3), disassemble the lyse bottle and cap assembly. 4. Unplug the tube on the filter assembly; 5. As following Figure shows. Use the 107 cross-headed screwdriver to remove the two M3 pan head screws fixing the filter, remove the rinse detecting assembly;
7-26
Servicing
Figure 7-25 Rinse detecting unit disassembly
1 ―――M3x6 pan head screws
2 ―――Rinse detecting rack
3 ―――Rinse detecting plate
4―――Sensor with connecting cable
5 ―――Rinse detecting cover
6―――Filter assembly
Installation: The installation procedures are the reverse order of step 1~5. Verification: 1. Check if the parts are assembled properly or not; 2. Make sure the tube connection and power cable connection are correct; 3. Turn on the instrument, go to counting screen, unplug the rinse cap assembly, don’t let the rinse go into the instrument. Count, observe if instrument could 7-27
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give the alarm. If it could reflect the real situation, that means the sensor works well.
7.8.7 Replacing the isolation chamber Purpose: Isolation chamber is used to filter the impurities and chippings from counting bath. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the counting bath; 2. Disassemble the shielding box of counting bath, do as Section 7.9.1; 3. Unplug the tube on the isolation chamber. Installation: The installation procedures are the reverse order of above steps. Verification: 1. Check if the parts are assembled properly or not; 2. Make sure the tube connection and power cable connection are correct; 3. Turn on the instrument to verify.
All the samples, controls, calibrators, reagents, wastes and areas contacted them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
7.8.8 Replacing the air filter Purpose: Air filter is used to filter the air in the instrument, to prevent the impurities to go into the tube and air pump. In case of malfunction, please replace the assembly in time, following is the detail steps. Tools: flat-headed screwdriver Removal: 1. Use the flat-headed screwdriver to rotate the lock on right door, to open the right side door.(see Figure 7-26)
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Figure 7-26 Open the side door
2.
The position of air filter is showed as following Figure;
Figure 7-27 Air filter
3. Remove air filter; Installation: Insert the new air filter to the tube, and close the right side door. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
7.9 Replacing the counting bath assembly 7.9.1 Disassemble the shielding box assembly Purpose: Shielding box is used to prevent interference during the counting process, it should be disassembled, while replacing the counting bath assembly, following is 7-29
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the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the front panel assembly(as per section 7.2.1); 4. Adjust the position of sample probe, keep the probe is out of the via hole of the shielding box; 5. As following Figure shows. Use the 107 cross-headed screwdriver to remove the four M3×8 pan head screws fixing the shielding box, take out the shielding box;
Please adjust the sample probe position, before disassemble the shielding box, make sure the sample probe is out of the shielding box to prevent the probe is bended or hurt the operator.
Figure 7-28 Shielding box disassembly
1 ――Shielding box
2 ――M3x8 cross-headed pan head screws
Installation: The installation procedures are the reverse order of step 1~5, please make sure not to press the liquid tube while cover the shielding box. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
7.9.2 Replacing the whole counting bath assembly Purpose: This part is used to count sample. In case of malfunction, please replace the assembly in time, following is the detail steps. 7-30
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Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the front panel assembly(as per section 7.2.1); 4. Open the right side panel(as per section 7.2.3); 5. Open the top panel(as per section 7.2.4); 6. Disassemble the shielding box(as per section 7.9.1); 7. Unplug the tubes and cable connectors on the counting bath; 8. As following Figure shows. Use the 107 cross-headed screwdriver to loose the four M3×6 pan head screws fixing the shielding box, but don’t remove them; 9. Lift the counting bath about 5mm manually, make the four screws located in the big hole, then take out the assembly.
Figure 7-29 Counting bath unit disassembly
Installation: The installation procedures are the reverse order of step 1~9, during installation, hang the assembly on the four screws via the gourd hole, tighten the screws. Then connect and arrange tubes. Make sure it’ s the same with previous, and never make any tubes bended and pressed. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
7.9.3 Replacing the WBC counting assembly WBC Purpose: This part is used to mix the sample and let sample react. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) 7-31
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Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the front panel assembly(as per section 7.2.1); 4. Open the right side panel(as per section 7.2.3); 5. Open the top panel(as per section 7.2.4); 6. Disassemble the shielding box(as per section 7.9.1); 7. Unplug the tubes and cable connectors on the counting bath; 8. As following Figure shows. Use the 107 cross-headed screwdriver to remove the two M3×6 pan head screws fixing the counting bath, and remove the counting bath cover board; 9. Take out the WBC counting bath.
Figure 7-30 WBC counting bath disassembly
1 --- Counting bath assembly
2 --- WBC assembly
3 --- Counting bath cover board
4 --- M3×6 cross-headed screw
Installation: The installation procedures are the reverse order of step 1~9, during installation, pay attention to the direction of the counting bath, Make sure it’ s the same with previous, and never make any tubes bended and pressed. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
7.9.4 Replacing the HGB assembly Purpose: HGB assembly is used to measure HGB. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) 7-32
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Removal: 1. Disassemble the WBC assembly(as per section 7.9.3); 2. Use the cross-headed screwdriver to remove the two M2X10 screws, disassemble the HGB assembly from counting bath.
Figure 7-31 HGB assembly disassemble
1 --- M2×22 cross-headed screw
2 --- HGB right part
3 --- O gasket 6×1
4 --- counting bath
5 --- HGB lift part Installation: The installation procedures are the reverse order of disassembly procedures. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
7.9.5 Replacing RBC counting bath assembly Purpose: This part is used to mix the sample and let sample react. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the front panel assembly(as per section 7.2.1); 4. Open the right side panel(as per section 7.2.3); 5. Open the top panel(as per section 7.2.4); 6. Disassemble the shielding box(as per section 7.9.1); 7. Unplug the tubes and cable connectors on the counting bath; 8. As following Figure shows. Use the 107 cross-headed screwdriver to remove 7-33
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9.
the two M3×6 pan head screws fixing the counting bath, and remove the counting bath cover board; Use cross-headed screwdriver to remove the ground cable, take out the WBC counting bath.
Figure 7-32 Disassemble the RBC counting bath
Installation: The installation procedures are the reverse order of step 1~9, during installation, pay attention to the direction of the counting bath, Make sure it’ s the same with previous, and never make any tubes bended and pressed. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
7.9.6 Replacing the ruby aperture and rear bath Purpose: This part is the flow path of the blood cell. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Disassemble the WBC assembly, and disassemble the HGB assembly, refer to Section 7.8.4(If disassemble RBC aperture, please disassemble the RBC assembly, refer to Section 7.8.5); 2. Use the cross-headed screwdriver to remove the two M3X10 screws, disassemble the rear bath, ruby aperture and front bath.
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Figure 7-33 Disassemble the ruby aperture and rear bath 1 --- Rear bath electrode
2 --- O gasket 6×1
3 --- Rear bath
4 --- Fluorubber gasket
5 --- ruby aperture
6 --- front bath gasket
7 --- Front bath
8 ---Cross-headed screw M3×10
Installation: The installation procedures are the reverse order of disassembly procedures. During installation, please pay attention to the direction of ruby aperture, the big hole should be face to front bath, it can not reverse. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
7.10 Replacing the syringe assembly Purpose: This part is used to dispense the fixed volume reagent or sample. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the top panel(as per section 7.2.4); 4. Open the right side panel (as per section 7.2.3), disassemble the lyse bottle and cap assembly. 5. Unplug all the tubes on the syringe; 6. Unplug the ground cable of filter, and unplug the syringe motor cable connector inside of instrument; 7. As following Figure shows. Use the 107 cross-headed screwdriver to remove 7-35
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the M3 pan head screws, remove the gasket, then take out the 10ml syringe assembly or dual-syringe assembly.
Please empty the liquid system, before replacing the syringe assembly. Otherwise, it’ll cause reagent leak or biological contamination. The syringe assembly is a little heavy, during replacement, please support the syringe assembly by hand, to prevent it drops and hurt people or instrument.
Figure 7-34 Disassemble the syringe assembly 1 ―――Dual-syringe assembly
2 ―――10ml syringe assembly
3 ―――gasket
4―――M3×12 cross-headed screw
5 ―――syringe grounding cable
6―――M3×12 cross-headed screw assembly
Installation: The installation procedures are the reverse order of disassembly steps 1~7. During installation, please make sure the connection and arrangement of the syringe assembly tubes are same with previous. Verification: 1. Check if the parts are assembled properly or not; 2. Make sure the tube connection and power cable connection are correct; 3. Turn on the instrument to verify.
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7.11 Replacing the sample probe assembly 7.11.1 Replacing the whole sample assembly Purpose: This assembly is used to aspirate and dispense the sample. In case of malfunction, please replace the assembly in time, following is the detail steps. Tools: 107 cross-headed screwdriver (107X75), positioning calibration fixture of sample probe Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the front panel assembly(as per section 7.2.1); 4. Open the top panel(as per section 7.2.4); 5. Open the right side panel (as per section 7.2.3), Disassemble the lyse bottle and cap assembly. 6. Unplug the all the tubes connected with the sample probe assembly; 7. Disconnect the cable connector for the motor and sensors; 8. As following Figure shows, Use the 107 cross-headed screwdriver to remove all the M3×8 pan head screws fixing the drive belt and sample probe assembly, then take out the whole assembly.
Figure 7-35 Disassemble the sample probe assembly 1 ―――Sample probe assembly
2 ―――M3×8 pan head screw
During installation, please care about the probe, to prevent the pricks. After installation, please recalibrate the horizontal and vertical position.
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Installation: The installation procedures are the reverse order of installation procedures, After installation, the horizontal and vertical position of sample probe needs to be recalibrated. Verification: 1. Go to “Setup”-> “service setting”-> “adjustment”, pop-up the screen as Figure 7-36 shows; Constant level adjustment
Constant level adjustment
of
of
WBC
bath
sample
dispensing position
RBC
bath
sample
dispensing position
Probe wipe constant level adjustment
Figure 7-36 The screen to adjust the sample probe and wipe block 2. Adjust the wipe block: For closed-reagent system: First, open the front panel(At this time, it’ll show “front panel is open” error message in screen, to take care of it after adjustment), see Figure-6B, Disassemble the tube baffle, remove the wipe block, and assemble the positioning calibration fixture of sample probe on the wipe block supporter by probe wipe fixing pin; Press “wipe block position” in “Y-direction motor” as Figure 7-36 shows, then press “start” button, after initialization, press “up” or “down” button to adjust the positioning calibration fixture of sample probe, make its bottom is in the same level with sample needle-point, see Figure-6C ; Then press “save” to save the setting; Remove the fixture, and assemble the wipe block and probe wipe fixing pin, tighten tube baffle to finish adjustment. For the open-reagent system: open the front panel, remove the wipe block, and assemble the positioning calibration fixture of sample probe on the wipe block supporter by probe wipe fixing pin, the adjustment steps are same with above, then remove the fixture, and assemble the wipe block to finish the adjustment.
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Tube baffle
Figure 7-37 Tube baffle
The bottom of the fixture is on the same level with the sample probe tip
Figure 7-38 Sample probe is in the same level with the wipe block 3.
Adjust WBC bath injection position: First, disassemble the shielding box, then remove counting bath diaphragm as Figure 7-39 shows, Press “WBC bath” in “X-direction motor” as Figure-6A shows. Then press “start”, press “right” to move the sample probe to the right side, then place the WBC/RBC bath calibration fixture properly and stably on the WBC bath as Figure 7-40 shows, Press “lift” button in the software screen to move the probe just into the aperture of fixture, then press “save”.
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Counting bath diaphragm
Figure 7-39 Counting bath diaphragm
Figure 7-40 Calibrate WBC bath injection position 4.
Adjust the RBC bath injection position: The same with above procedures, Press “RBC bath” in “X-direction motor” to adjust the RBC bath injection position and save the setting as Figure-6F shows.
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5. 6. 7.
Figure 7-41 Calibrate the RBC bath injection position Fix the counting bath diaphragm on the bath assembly, during the installation, please make sure there is no any tube crimped. Confirm the connection cable, tube, screws is assembled properly and tightly, and keep the position of tube is the same with previous. Turn on the instrument to verify.
All the samples, controls, calibrators, reagents, wastes and areas contacted them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
7.11.2 Replacing the vertical movement assembly Purpose: Vertical movement assembly is used to drive and locate the sample probe in vertical direction. In case of malfunction, please replace the assembly in time, following is the detail steps. Tools: 2.5 Allen Key, Positioning calibration fixture of sample probe Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the front panel assembly(as per section 7.2.1); 4. Open the right side panel(as per section 7.2.3), Disassemble the lyse bottle and cap assembly. 5. Unplug the tubes and cable connectors on the sample probe assembly; 6. As following Figure shows. Use the 2.5 Allen key to remove the two M3 Allen type socket screws, pull out the parallel guidance bar from lift side; 7. In the back of the panel, use the 2.5 Allen key to loose the M3 Allen type 7-41
Servicing
socket screws, then take out the vertical movement assembly in front.
Figure 7-42 Disassemble the vertical movement assembly 1 ―――Parallel guidance bar
2 ―――slide block
3 ―――M3×6 Allen type stock screw
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Installation: The installation procedures are the reverse order of disassembly, before tightening the two Allen type stock screws on slide block, move the horizontal part to right side, and keep it is closed with the end face of slide block, then tighten the crews. After installation, please recalibrate the position of sample probe. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
Please pay attention to the sample probe during installation, to prevent to be pricked; after installing the vertical movement assembly, please recalibrate the probe vertical movement.
During adjustment, please wait for the “Menu” to become the normal ground color before operation, otherwise, the “system is busy, please try again later” warning message will pop-up;
Please make sure the tube baffle is installed properly, otherwise there is a risk to happen interference;
After counting bath diaphragm installation, please make sure the counting bath diaphragm is not crimped.
7.11.3 Replacing the horizontal movement assembly Purpose: Vertical movement assembly is used to drive and locate the sample probe in vertical direction. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Disassemble the whole sample assembly, steps and attention as Section 7.11.1 mentioned; 4. As following Figure shows. Use the 107 crossing screw driver to remove the three M3 screws fixing the fluidic tube support assembly, take out the liquid tube assembly; 5. Disassemble the vertical movement assembly, steps and attention as Section 7.11.2 mentioned; 6. Disassemble the sample probe assembly, steps and attention as Section 7.11.4 mentioned, to remove horizontal movement assembly.
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Figure 7-43 Disassemble the horizontal movement assembly 1 ―――Sample probe assembly
2 ―――Fluidic assembly
tube
support
3 ―――M3×8 crossing screw Installation: The installation procedures are the reverse order of disassembly。 Verification: 1. After installation, move the assembly repeatedly, make sure it moves smoothly, there are not stagnation and noise; 2. Check if the parts are assembled properly or not; 3. Turn on the instrument to verify.
7.11.4 Replacing the sample probe assembly Purpose: Sample probe is an important part for sample collection, in case of attrition or deformation, please replace the assembly in time, following is the detail steps. Tool: 107 cross-headed screwdriver (107X75),Positioning calibration fixture of sample probe Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable; 3. Open the front panel assembly(as per section 7.2.1); 4. Unplug the all the tubes connected with the sample probe assembly; 5. As following Figure shows. Use the 107 crossing screw driver to remove the two M3 screws fixing the pressure plate, take out the pressure plate; 7-44
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6.
Disassemble the sample probe.
Figure 7-44 Disassemble the sample probe Installation: The installation procedures are the reverse order of disassembly procedures. During the installation, please pay attention to the direction of probe; After installation, please re-calibrate the probe. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
All the samples, controls, calibrators, reagents, wastes and areas contacted them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
7.11.5 Replacing the probe wipe fixing pin Purpose: Probe wipe fixing pin is used to fix the probe wipe. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: Nothing. Removal: 1. Power off the instrument and unplug the power cable. 2. Open the front panel assembly(as per section 7.2.1); 7-45
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3.
Pull the probe wipe fixing pin downward by hand as following Figure shows;
Figure 7-45 Disassemble the probe wipe fixing pin Installation: Before installation, please install the sample probe and probe wipe in advance, and lift up the probe wipe, let its top shore up the bottom of wipe supporter, then push the probe wipe fixing pin to probe wipe along the underside of supporter, make the circle of the pin is faced to the fillister in the probe wipe. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
7.11.6 Replacing the probe wipe Purpose: Probe wipe assembly is used to clean the outside of the probe. In case of malfunction, please replace the assembly in time, following is the detail steps. Tool: Nothing. Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the front panel assembly(as per section 7.2.1); 4. Unplug the all the tubes connected with the probe wipe; 5. Disassemble the sample probe assembly, steps and attention as Section 7.11.4 mentioned; 6. Disassemble the probe wipe fixing pin, steps and attention as Section 7.11.5 mentioned; 7. Pull out the probe wipe assembly.
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Figure 7-46 Disassemble the probe wipe assembly 1 ―――Probe wipe fixing pin
3 ―――Probe wipe assembly
2 ―――Probe wipe supporter Installation: The installation procedures are the reverse order of disassembly procedures. During the installation, please pay attention to the direction of probe; After installation, please re-calibrate the probe. Verification: 1. Check if the parts are assembled properly or not; 2. Turn on the instrument to verify.
All the samples, controls, calibrators, reagents, wastes and areas contacted them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
7.12 Replacing the sample compartment assembly 7.12.1 Sample Compartment Assembly Purpose: The sample compartment assembly can be removed or replaced as instructed by this section. Tool: 107 cross-headed screwdriver(107X75) Removal: 7-47
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1. 2. 3. 4.
5. 6. 7.
Empty the liquid system; Power off the instrument and unplug the power cable; Open the front panel assembly(as per section 7.2.1); Open the right side panel(as per section 7.2.3), Disassemble the lyse bottle and cap assembly. Unplug the all the cables connected with the sample probe assembly; Disconnect the cable connector for the motor and sensors; Use the 107 cross-headed screwdriver to remove all the four M3×8 pan head screws; Take out the sample compartment assembly, take care of the cables.
Figure 7-47 Disassemble the sample compartment assembly 1 ―――Sample compartment assembly
2 ―――front panel
3 ―――M3X8 screw
During disassembly and installation, please keep the sample probe always in upper position.
Installation: 7-48
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1.
When replacing the sample compartment assembly, the installation procedures are the reverse order of above steps 1 to step 3; 2. Adjust the goodness of fit between the sample compartment door and front panel.(Refer to Section 7.12.2) Verification: 1. Check if all the cables(include motor) are connected well or not; 2. Close front panel, check the goodness of fit between the compartment door and front panel; 3. Plug the power cable, turn on the instrument; 4. Perform initialization, observe the door to open and close; 5. Further check, go to “Menu”-> “service”, perform sample compartment many times, to observe whether the door can open and close normally.
7.12.2 Sample compartment door Purpose: The sample compartment door can be replaced or adjusted as instructed in this section. Tools: 107 cross-headed screwdriver(107X75), 2.5mm hex wrench. Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the front panel assembly(as per section 7.2.1); 4. Use the 2.5mm hex wrench to remove four M3×8 pan head screws, take out the sample compartment door.
Figure 7-48 Disassemble the sample compartment door 1 ―――Sample compartment door
2 ―――Door supporter
3 ―――M3x8 screw
4―――M3x16 socket head screw
Installation: 7-49
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1. When disassembling the sample compartment door separately, install the door on the assembly, then slightly screw the four M3x8 screws to fix the door, not too tight; 2. Close the front panel, move the door, make the upper gap and side gap almost same; 3. Open the front panel, make sure the compartment door not to be implicated;(please hold the door by your hand) 4. Tighten the four M3x8 screws to finish the installation and adjustment; 5. When replacing the whole sample compartment assembly, loose the two M3x16 stock head screws fixing the door supporter; 6. Repeat the step 1 to step3; 7. Tighten the two M3x16 stock head screws and four M3x8 screws to finish the installation and adjustment.
Figure 7-49 Adjust the sample compartment door Verification: 1. Close front panel, check the goodness of fit between the compartment door and front panel; 2. Plug the power cable, turn on the instrument; 3. Perform initialization, observe the door to open and close; 4. Further check, go to “Menu”-> “service”, perform sample compartment many times, to observe whether the door can open and close normally.
7.12.3 Replacing the fixture of tube holder adapter Purpose: The fixture of tube holder adapter can be replaced or adjusted as instructed in this section. Tools: 3mm hex wrench. Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the front panel assembly(as per section 7.2.1); 4. Use the 3mm hex wrench to remove M4x10 socket head screws fixing the card, take out the card.
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Figure 7-50 Fixture of tube holder adapter 1 ―――Fixture of tube holder adapter
2 ―――M4x8 socket head screw
Installation: Insert the fixture of tube holder adapter to corresponding card slot, and tighten the M4x12 socket head screws. Verification: Make sure all the parts are assembled properly.
7.12.4 Replacing the tube baffle Purpose: The tube baffle can be replaced or adjusted as instructed in this section. Tools: 107 cross-headed screwdriver(107X75) Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable; 3. Open the front panel assembly(as per section 7.2.1); 4. Use the 107 cross-headed screwdriver to remove two screws, take out the tube baffle.
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Figure7-51 Disassemble the tube baffle 1 ―――Tube baffle Installation: Verification:
2 ―――screw
Locate the tube baffle as the position of screws, tighten the two screws. Make sure all the parts are assembled properly.
7.12.5 Further disassembly for sample compartment assembly Purpose: The closing door assembly, open-close detecting switch, driver motor and flanged deep-slot ball bearing can be replaced as instructed in this section. Tools: 107 cross-headed screwdriver(107X75), 2.5mm hex wrench, 1.5mm hex wrench. Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable; 3. Open the front panel assembly(as per section 7.2.1); 4. Open the right side panel(as per section 7.2.3), Disassemble the lyse bottle and cap assembly. 5. Disassemble the sample compartment assembly;(as per section 7.12.1) 6. Use the cross-headed screwdriver to remove two M3×8 pan head screws, disassemble the closing door assembly;
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Figure 7-52 Closing door assembly 1 ―――Closing door assembly
2 ―――pan head screw M3X8
Disassemble the driver motor: 1. Use the cross-headed screwdriver to remove two M3×8 pan head screws, disassemble the closing door assembly; 2. Use the 1.5mm hex wrench to loose the two M3x5 screws to remove the small synchromesh gear.
Figure 7-53 Disassemble driver motor 7-53
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1 ―――Driver motor
2 ―――Small band wheel MXL16
3 ―――M3x5screw
4 ―――pan head screw M3X8
Disassemble the open-close detecting switch: 1. Use the cross-headed screwdriver to remove four M3×8 pan head screws, disassemble the driver step motor; 2. Use the cross-headed screwdriver to loose the two M3×8 pan head screws to remove the open-close detecting switch with the supporter together; 3. Use the cross-headed screwdriver to loose the two M3×8 pan head screws to remove the open-close detecting switch from the supporter.
Figure 7-54 Disassemble the open-close detecting switch 1 ―――Pan head screw M3X8
2 ―――open-close detecting switch
3 ―――supporter
4 ―――Pan head screw M3X8
Disassemble the flanged deep-slot ball bearing: 1. Disassemble the flanged deep-slot ball bearing in left side(without motor). Use the cross-headed screwdriver to loose the two M3×8 pan head screws to remove the flanged deep-slot ball bearing;
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Figure 7-55 Disassemble the flanged deep-slot ball bearing in left side 1 ―――flanged deep-slot ball bearing 5x14x3.5
2 ―――pan head screw M3X8
2. Disassemble the flanged deep-slot ball bearing in left side(with motor). Use the cross-headed screwdriver to loose the four M3×8 pan head screws to remove the synchronous belt; 3. Use the 2.5mm hex wrench to loose the two M3x12 screws to remove the big band wheel; 4. Use cross-head driver to loose the two M3x8 small pan head screws, remove the right side flanged deep-slot ball bearing.
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Figure 7-56 Disassemble the right side flanged deep-slot ball bearing 1―――synchronous belt
2―――big band wheel
3 ―――M3X12 Allen type stock screw
4 ―――Pan head screw M3X8
5 ―――flanged deep-slot ball bearing 5x14x3.5 Installation: 1. The installation procedures are the reverse order of disassembly; 2. The outside of the big band wheel should be parallel with the shaft surface; 3. Tighten the screws; 4. The tension of synchronous belt. Don’t tighten the four screws fixing the motor at the first, push the motor to force the synchronous belt tight(about 1kg force), then use the cross-head driver to tighten the four screws. Verification: The same with Section 7.11.1.
7.13 Replacing the start key Purpose: The start key can be replaced or adjusted as instructed in this section. Tools: 2.5mm hex wrench; Removal: 1. Power off the instrument and unplug the power cable. 2. Open the front panel assembly(as per section 7.2.1); 3. Open the right side panel(as per section 7.2.3), Disassemble the lyse bottle and cap assembly. 7-56
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4.
As following Figure shows, Use the 2.5mm hex wrench to remove two M3×6 Allen type socket screws, take out the start key;
Figure 7-57 Disassemble the start key Installation: Please put the start key in front and the lower end faces to the limit-lead. Verification: Check whether the start key can move normally without any barriers. And check the gap between start key and front panel, it should be uniform.
7.14 Micro-Switch Assembly Replacement Purpose: Need replacement when micro-switch is faulty. Tools: 107x75 Cross screw driver Removal: 1. Turn-off main unit, and plug out power cable 2. Open the front panel, the related steps and notice as 7.2.1 indicates. 3. Open Right panel, the related steps and notice as 7.2.3 indicates. 4. As Figure 7-58, loose two M2x10 cross-head screws with 107x75 cross screw driver and take down the screws.
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Figure 7-58 Disassemble Micro-switch 1 ―――M2×10 cross pan-head screw
2 ―――micro switch
3 ―――Press Button Installation: Installation procedure is reverse steps to disassemble. Verification: No stuck with press button, meantime, check the gap between button and panel, make sure it’s consistent.
7.15 Fluidic Support-bracket Assembly Purpose: Need replacement when the tubing support-bracket faulty. Tools: 107x75 cross screwdriver Removal: 1. Run drain program firstly. 2. Power-off the main unit and plug out power cord. 3. Open the front panel, the steps and notice as 7.2.1 indicates. 4. Pull out the tube connected to sample probe. 5. As Figure 7-59, take out three M3x8 stainless cross pan-head screws assembly with 107x75 cross screw driver, and take out tubing assembly.
7-58
Servicing
Figure 7-59 Disassemble Fluidic Support-bracket 1 ―――Sampling assembly
2―――Tubing Support-bracket
3 ―――M3×8 stainless cross pan-head screw assembly Installation: Installation procedure is reverse steps to disassemble Verification: Make sure all parts well installed and fixed, and tubing is smooth.
7.16 Front Panel Detection Assembly Purpose: Detection assembly is used to detect if the front panel is open or not, when it’s defective, need to replace. Tools: 107x75 cross screw driver Removal:1. Power-off the main unit and plug out power cord. 2. Open the front panel, the steps and notice as 7.2.1 indicates. 3. Open the top panel, the steps and notice as 7.2.4 indicates. 4.As figure 7-60, loose the three M3x6 cross countersunk head screws,and take down the open-close detection assembly.
7-59
Servicing
Figure 7-60 Disassemble front panel detection assembly 1 ―――Front panel detection assembly
2 ―――Front board
3 ―――M3 × 6 cross countersunk head screws Installation: Installation procedure is reverse steps to disassemble Verification: Repeatedly press detection assembly of front panel and make sure move smooth and no stuck.
7.17 Ambient Temperature Sensor Replacement Purpose: When the Temp. Sensor is defective, it need replacement. Tools: Plier or wrench Disassembly: 1. Power-off the main unit and plug out power cord. 2. Open the front panel, the steps and notice as 7.2.1 indicates. 3. Open the top panel, the steps and notice as 7.2.4 indicates. 4. Take out M5 screws with pliers or wrench, which used to fix temp. sensor. 5. Take out ambient temperature sensor and connection cable. Installation: Installations reverse steps to disassemble, please notice not to ignore rubber o-ring in installation procedure. Verification: Please verify the temperature sensor is reliable and the indicated temperature is correct.
7-60
Servicing
7.18 Cap Assembly Purpose: When reagent cap assembly is broken, Tools: None Removal (Lyse Cap Assembly): 1.Please run drain program firstly 2. Please plug-out power cord after power-off 3. Open the right panel door, the steps and notices as 7.2.3 indicates. 4. Please take out orange connecter in counter-clockwise, and move up the connecter and tubes in case of some left fluidic drops. 5. Then loosing cap assembly in counter-clockwise, then pull up the whole lyse cap assembly.
Figure 7-61 Lyse Cap Assembly Disassembly Diluent Cap Assembly, Rinse Cap Assembly, Waste Cap Assembly: Removal: 1. Run the drain program firstly; 2. Please plug out power cord after turn-off; 3. Please loose the cap assembly related colored connectors in counter-clockwise (waste cap assembly need to loose BNC connecter); Diluent cap connecter is green, Rinse cap connecter is blue , the waste cap connecter is red; 4. Loose the cap and pull up the whole assembly. Installation: Please insert the tube into reagent bottle firstly, and tighten the connecter and cap in clockwise (waste cap need to tighten BNC connecter as well) . Verification: Make sure the assembly is well tightening, no kinkled tube, and run some tests to verify. 7-61
Servicing
All the samples, controls, calibrators, reagents, wastes and areas contacted them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
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.
When loose the Cap connecter, and be careful with left liquid drops on the instrument or table.
Please tighten the reagent cap in case of the reagent contaminated when the reagent and analyzer was connected.
7.19 Gain Adjustment Purpose: Gain Setup, to ensure instrument work in defined status. Adjustment Method: 1. With service login, press Menu ‘Setup’ ’Gain Setup’ to enter following ‘Gain Setup’ screen as shown in Figure 7-62.
7-62
Servicing
Figure 7-62 Gain Adjustment Screen 2、Only the edit is activated, you can adjust the gain value. If the gain setup exceeding the effective range or the value is empty, the system will give ‘Input invalid’, and recover the values back to original. 3、After input the valves, you can press the menu or other figure button, it will pop up following dialogue. Press ‘Yes’, Save the setting and switch the screen; click’ No’ to exit the dialogue without save.
Figure 7-63 Save Screen Caution: 1、Before Setup, please press ‘Menu’ ‘Service’ ‘Maintenance’ ‘Prime’ ‘All Reagents’,After finish ‘prime’, press ‘Menu’ ‘Setup’ ‘Service’ ‘Background data monitoring’, then go to background data monitoring screen, press ‘background’ screen, and press’ background’ button, execute daily check, and observe if there are bubbles in RBC bath during courting process? 2、As shown in figure 7-64, please check if WBC bath full with reagents and HGB light is turned on, meanwhile observe if any bubble in inner bath wall. if it is, please make trouble-shooting, then input the new gain value and make the HGB blank voltage around 4.5±0.2V , then ‘save’ to exit.
7-63
Servicing
Figure 7-64 WBC counting bath and HGB assembly (Right panel)
7.20 Motor Type, Position and Different Application List No
Motor Type
Position
Application
Step motor
Horizontal Movement Assembly
Drive the sampling assembly to move in horizontal direction
2
Step motor
Vertical Movement Assembly
Drive the sampling assembly to move in vertical direction and accomplish puncture, sampling and sample dispense.
3
Step motor
Sampling Assembly
1
Door Accomplish the sampling door open-close action.
7.21 The Check List After Material Replacement No
Material Description
Steps to Replace and Verify 1. Empty fluidics and shut down the analyzer
Home-made three-way
1
electromagnetic valve service kit
2. Replace the valve and start up the analyzer according to standard procedures 3. Make sure there is no leakage in tube connections 4. Go to the valve test screen to verify if the valve works properly
7-64
Servicing 1. Empty fluidics and shut down the analyzer Home-made two-way
2
electromagnetic valve service kit
2. Replace the valve and start up the analyzer according to standard procedures 3. Make sure there is no leakage in tube connections 4. Go to the valve test screen to verify if the valve works properly 1. Empty fluidics and shut down the analyzer 2. Replace the tube and start up the analyzer according to standard procedures. 3. Make sure there is no leakage in tubing connections
3
and no liquid suspending on the wall of the
Volumetric Tubing Assembly
volumetric tube 4. Set up the volume of the volumetric tubing at the corresponding screen 5. Monitor the background information. 6. Calibrate in the whole-blood mode 7. Calibrate in the predilute mode
4
Filter
N/A 6.
Empty fluidics and shut down the analyzer. Replace the bath, and then start up the analyzer according to standard procedures, make sure the tubes are connected properly and there is no leakage
7.
Perform gain calibration
8.
Verify the HGB and MCV values, as well as the lymphocyte peak value in the WBC histogram after gain calibration
9.
5
WBC bath assembly
Monitor the background information
10. Calibrate in the whole-blood mode 11. Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 12. Calibrate in the predilute mode 13. Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 14. Test repeatability using normal-level control in the whole-blood mode and predilute mode 1.
Empty fluidics and shut down the analyzer. Replace the bath, and then start up the analyzer according to standard procedures, make sure the tubes are
6
RBC bath Assembly
connected properly and there is no leakage 2.
Perform gain calibration
3.
Verify t MCV values, as well as RBC histogram after gain calibration 7-65
Servicing 4.
Monitor the background information
5.
Calibrate in the whole-blood mode
6.
Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS
7.
Calibrate in the predilute mode
8.
Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS Test repeatability using normal-level control in the whole-blood mode and predilute mode.
1.
Empty fluidics and shut down the analyzer. Replace the aperture, and then start up the analyzer according to standard procedures. Make sure the tubes are properly connected and there is no leakage
2.
Perform gain calibration
3.
Verify the HGB and MCV values, as well as the peak values in the WBC histogram after gain calibration
7
Aperture sensor (D80um)
4.
Monitor the background information
5.
Calibrate in the whole-blood mode
6.
Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS
7.
Calibrate in the predilute mode
8.
Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS
9.
Test repeatability using normal-level control in the whole-blood mode and predilute mode
1. Empty fluidics and shut down the analyzer. Replace the bath, and then start up the analyzer according to standard procedures. Make sure the tubes are properly connected and there is no leakage 2. Perform gain calibration 3. Verify the HGB and MCV values, as well as the peak
8
WBC bath service parts (without aperture)
values in the WBC histogram after gain calibration 4. Monitor the background information 5. Calibrate in the whole-blood mode 6. Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 7. Calibrate in the predilute mode 8. Run the calibrator after finishing calibration, and
7-66
Servicing verify the result according to the specifications in the PRS 9. Test repeatability using normal-level control in the whole-blood mode and predilute mode 1、 Empty fluidics and shut down the analyzer. Replace the bath, and then start up the analyzer according to standard procedures. Make sure the tubes are properly connected and there is no leakage 2、 Perform gain calibration 3、 Verify the MCV values, as well as RBC histogram after gain calibration 4、 Monitor the background information
9
RBC bath service parts
5、 Calibrate in the whole-blood mode
(without aperture)
6、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 7、 、 Calibrate in the predilute mode 8、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 9、 Test repeatability using normal-level control in the whole-blood mode and predilute mode 1、 Empty fluidics and shut down the analyzer. Replace the bath, and then start up the analyzer according to standard procedures. Make sure the tubes are properly connected and there is no leakage 2、 Perform gain calibration 3、 Verify the HGB and MCV values, as well as the peak values in the WBC histogram after gain calibration 4、 Monitor the background information
10
WBC bath service parts
5、 Calibrate in the whole-blood mode
(without HGB)
6、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 7、 、 Calibrate in the predilute mode 8、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 9、 Test repeatability using normal-level control in the whole-blood mode and predilute mode 1、 Empty fluidics and shut down the analyzer. Replace
11
Bath Washer Service Parts
the bath, and then start up the analyzer according to standard procedures 2、 Make sure the tubes are connected properly and
7-67
Servicing there is no leakage 3、 Perform gain calibration 4、 Verify the HGB and MCV values, as well as the peak values in the WBC histogram after gain calibration 5、 Monitor the background information 6、 Calibrate in the whole-blood mode 7、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 8、 、 Calibrate in the predilute mode 9、 、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 1、 Empty fluidics and shut down the analyzer 2、 Replace the syringe and start up the analyzer according to standard procedures 3、 Make sure the tubes are connected properly and there is no leakage 4、 Calibrate in the whole-blood mode 5、 Run the calibrator after finishing calibration, and
12
2.5ml home-made syringe (fluorine rubber)
verify the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 8、 Test repeatability using the normal-level control in the whole-blood mode 9、 Test repeatability using the normal-level control in the predilute mode 1、 Empty fluidics and shut down the analyzer. Replace the syringe, and then start up the analyzer according to standard procedures 2、 Make sure the tubes are connected properly and there is no leakage 3、 Remove bubbles in the 100ul syringe
13
100µL assembly
syringe
service
4、 Calibrate in the whole-blood mode 5、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS
7-68
Servicing 8、 Test repeatability using the normal-level control in the whole-blood mode 9、 Test repeatability using the normal-level control in the predilute mode 1、 Empty fluidics and shut down the analyzer. Replace the syringe, and then start up the analyzer according to standard procedures 2、 Make sure the tubes are connected properly and there is no leakage 3、 Calibrate in the whole-blood mode 4、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the
14
10ml home-made syringe
PRS 5、 、 Calibrate in the predilute mode 6、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 7、 Test repeatability using the normal-level control in the whole-blood mode 8、 Test repeatability using the normal-level control in the predilute mode 1、 Empty fluidics and shut down the analyzer 2、 Replace the isolation chamber, and then start up the analyzer according to standard procedures. Make
15
Isolation chamber
sure that the waste can be drained through the isolation chamber 3、 Make sure the tubes are connected properly and there is no leakage 1、 Empty fluidics and shut down the analyzer 2、 Replace the probe and start up the analyzer according to standard procedures 3、 Refix the position of the probe wipe 4、 Calibrate in the whole-blood mode 5、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the
16
Open-vial sample probe
PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 8、 Test repeatability using the normal-level control in the whole-blood mode 9、 Test repeatability using the normal-level control in the predilute mode
7-69
Servicing 1、 Empty fluidics and shut down the analyzer 2、 Replace the probe wipe and start up the analyzer according to standard procedures 3、 Make sure there is no leakage in the new probe wipe 4、 Calibrate in the whole-blood mode 5、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the
17
Probe Wipe
PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 8、 Test repeatability using the normal-level control in the whole-blood mode 9、 Test repeatability using the normal-level control in the predilute mode 1、 Empty fluidics and shut down the analyzer 2、 Replace the probe and start up the analyzer according to standard procedures 3、 Refix the position of the probe wipe 4、 Calibrate in the whole-blood mode 5、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the
18
Piercing probe
PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 8、 Test repeatability using the normal-level control in the whole-blood mode 9、 Test repeatability using the normal-level control in the predilute mode 1、 Perform rinse priming, and make sure that the rinse
19
Rinse cap assembly
can be aspirated into the analyzer 2、 No leakage around the rinse connector in the rear panel 1、 Perform lyse priming, and make sure that the lyse
20
Lyse cap assembly
can be aspirated into the analyzer 2、 No leakage around the lyse connector in the back panel 1、 Perform diluent priming, and make sure that the
21
Diluent cap assembly
diluent can be aspirated into the analyzer 2、 No leakage around the diluent connector in the back panel 7-70
Servicing 1、 Remove the BNC connector of the waste cap
22
Waste cap assembly (drain
assembly in the back panel, and check if
waste to waste container)
container full error is reported. Put the connector
the waste
back, and the error is removed 1、 Make sure that the fluidic pump is working properly
23
Fluidic pump assembly
and there is no leakage 2、 Go to the system test screen to test the vacuum pressure, and check if the result is OK
24
Air pump assembly
1、 Go to the system test screen to test the pressure of the pressure chamber, and check if the result is OK 1、 Empty fluidics first
25
Rinse detection assembly
2、 Replace the rinse detection assembly, and then adjust the potentiometer on the driver board 3、 Go to the adjustment screen to make adjustment
26
Vacuum chamber assembly Rubber pipe. 3/32"X5/32",
27
S-50-HL(replace with the wider rubber pipe of the towline) Rubber
28
pipe.1/16"X1/8",
S-50-HL(replace with the narrower rubber pipe of the towline)
N/A 1、 Empty fluidics and shut down the analyzer 2、 Replace the pipe and start up the analyzer according to standard procedures 1、 Empty fluidics and shut down the analyzer 2、 Replace the pipe and start up the analyzer according to standard procedures
Rubber pipe. PTFE,
29
1/32"X1/16",30 (0.78
1、 Empty fluidics and shut down the analyzer
TEFLON; replace with the
2、 Replace the pipe and start up the analyzer according
0.78 TEFLON pipe of the
to standard procedures
RBC isolation chamber) Rubber pipe. PTFE,
30
0.066"X0.098"X (1.5
1、 Empty fluidics and shut down the analyzer
TEFLON; replace with the
2、 Replace the pipe and start up the analyzer according
T20 storage pipe between
to standard procedures
V4 and V12) Rubber pipe OD3mm
31
ID1mm EVA (narrow EVA,
1、 Empty fluidics and shut down the analyzer
sampling pipe, use the pipe
2、 Replace the pipe and start up the analyzer according
connecting the towline and
to standard procedures
the sample probe)
32
CF card (1G) service kit
1、 Export parameters
(with software)
2、 Restore parameters 1、 Export parameters
33
Data board
2、 Replace the data board and start up the analyzer according to standard procedures 3、 Restore parameters 7-71
Servicing 1、 Export parameters
34
2、 Replace the data board and start up the analyzer
Driver board
according to standard procedures 3、 Restore parameters 1、 Connect to the power supply, and make sure that you can start up and shut down the analyzer by pressing
35
Power board
the power button 2、 In the system status screen, make sure all the voltage values are in specified ranges 1、 Make sure that the interval between the shielding cover of the interface board and the side door of the circuit is even
36
Interface board
2、 Test all the USB interface with the USB interface of the keyboard to make sure all the interfaces function properly 3、 Test the serial interfaces 1、 Empty fluidics and shut down the analyzer. Replace the volumetric board, and then start up the analyzer according to standard procedures 2、 Check and make sure the pressures of the vacuum chamber and pressure chamber are OK 3、 Monitor the background information 4、 Calibrate in the whole-blood mode 5、 Run the calibrator after finishing calibration, and
37
Volumetric metering board
verify the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 8、 Test repeatability using the normal-level control in the whole-blood mode 9、 Test repeatability using the normal-level control in the predilute mode
38 39 40
1、 Open the front cover, check if the indicator is red and
Indicator Board Sample
the buzzer buzzes
compartment
connection board TR60-D
compartment test. Make sure the test result is OK
recorder
driver
board
41
Touch Screen
42
Inverter
43
Photocoupler
1、 Go to the system test screen and perform the sample 1、 Print at the count screen and make sure the printout is OK
1、 Calibration on Touch Screen after replacement 1、 Make sure the analyzer can be started up and the screen displays properly and
its
1、 Run a background cycle and make sure the sampling 7-72
Servicing connecting
cables
(the
assembly functions properly
vertical photocoupler of the sampling assembly) 1、 Empty fluidics and shut down the analyzer. Start up the analyzer according to standard procedures after replacing the HGB. Set up the HGB blank voltage gain 2、 Perform gain calibration 3、 Verify the HGB and MCV values, as well as the peak values in the WBC histogram after gain calibration 4、 Calibrate in the whole-blood mode 5、 Run the calibrator after finishing calibration, and
44
HGB assembly
verify the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 8、 Test repeatability using the normal-level control in the whole-blood mode 9、 Test repeatability using the normal-level control in the predilute mode
45
1、 Print at the count screen and make sure the printout
Recorder
is OK 1、 Adjust the interval between the compartment and the cover
46
Sample
compartment
assembly
2、 Test the sample compartment in the system test screen, and make sure the result is OK 3、 Adjust the position of the sample probe relative to the tube in the sample compartment
47 48
Sample compartment door
Door secure assembly
1、 Adjust the interval between the door and the cover 1、 Test the sample compartment in the system test screen, and make sure the result is OK 1、 Fix the position of the sample probe wipe 2、 Adjust the position of the sample probe in the WBC/RBC bath and the sample compartment 3、 Calibrate in the whole-blood mode
49
Sampling assembly
4、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 5、 、 Calibrate in the predilute mode 6、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the 7-73
Servicing PRS 7、 Test repeatability using the normal-level control in the whole-blood mode 8、 Test repeatability using the normal-level control in the predilute mode 1、 Fix the position of the sample probe wipe 2、 Adjust the position of the sample probe in the WBC/RBC bath and the sample compartment 3、 Calibrate in the whole-blood mode 4、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS
50
Vertical motion assembly
5、 、 Calibrate in the predilute mode 6、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 7、 Test repeatability using the normal-level control in the whole-blood mode 8、 Test repeatability using the normal-level control in the predilute mode 1、 Empty fluidics and shut down the analyzer
51
Fluidic
Pipe
Bracket
Assembly
2、 Replace the assembly and start up the analyzer according to standard procedures. Make sure there is no leakage 1、 Empty fluidics first. Replace the syringe, and then start
up
the
analyzer
according
to
standard
procedures 2、 Make sure the tubes are connected properly and there is no leakage 3、 Remove bubbles in the 100ul syringe 4、 Calibrate in the whole-blood mode 5、 Run the calibrator after finishing calibration, and
52
Double Syringe Assembly
verify the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 8、 Test repeatability using the normal-level control in the whole-blood mode 9、 Test repeatability using the normal-level control in the predilute mode
53
Double Assembly
Syringe
Drive
1、 Empty fluidics first. Replace the syringe, and then start 7-74
up
the
analyzer
according
to
standard
Servicing procedures 2、 Make sure the tubes are connected properly and there is no leakage 3、 Remove bubbles in the 100ul syringe 4、 Calibrate in the whole-blood mode 5、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 8、 Test repeatability using the normal-level control in the whole-blood mode 9、 Test repeatability using the normal-level control in the predilute mode 1、 Empty fluidics first. Replace the syringe, and then start
up
the
analyzer
according
to
standard
procedures 2、 Make sure the tubes are connected properly and there is no leakage 3、 Calibrate in the whole-blood mode 4、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the
54
10ml Syringe Assembly
PRS 5、 、 Calibrate in the predilute mode 6、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 7、 Test repeatability using the normal-level control in the whole-blood mode 8、 Test repeatability using the normal-level control in the predilute mode 1、 Empty fluidics first. Replace the syringe, and then start
up
the
analyzer
according
to
standard
procedures 2、 Make sure the tubes are connected properly and
55
Single Assembly
Syringe
Drive
there is no leakage 3、 Calibrate in the whole-blood mode 4、 Run the calibrator after finishing calibration, and verify the result according to the specifications in the PRS 5、 、 Calibrate in the predilute mode 6、 Run the calibrator after finishing calibration, and 7-75
Servicing verify the result according to the specifications in the PRS 7、 Test repeatability using the normal-level control in the whole-blood mode 8、 Test repeatability using the normal-level control in the predilute mode 1、 Start up the analyzer and make sure the screen
56
Screen assembly
57
Adapter Assembly 1
N/A
58
Adapter Assembly 2
N/A
display is OK
1、 Connect to the power supply, and make sure that you
59
Power Supply Assembly
can start up and shut down the analyzer by pressing the power button 2、 In the system status screen, make sure all the voltage values are in specified ranges 1、 Make sure the key can sink and resile smoothly and
60
Aspirate Key
the probe functions properly while the aspirate key is pressed
61
Front
Cover
Status
Detection Assembly
1、 Make sure there is alarm sound while the front cover is open and the error can be removed manually after the cover is closed 1、 Start
62
Power Cord for Zapping
up
the
procedures.
analyzer
Click
the
according "Zap"
to
button
standard at
the
maintenance screen, and make sure you can hear the hiss while zapping
Sample
63
Micro-switch
Compartment Switching
Cable
64
Valve Control Connecting Wiring
1、 Start
65
Wiring (closed model)
the
analyzer
according
to
standard
procedures. Test the sample compartment at the system test screen, and make sure the result is OK 1、 Start
up
the
analyzer
according
to
standard
procedures. Perform valve test and make sure all the valves work properly 1、 Start
Motor Control Connecting
up
up
the
analyzer
according
to
standard
procedures. At the system test screen: click "ASP/LS motor", "DIL motor", "X motor" and "Y motor" in turn, and make sure the test results are OK 2、 Test the sample compartment in the system test screen, and make sure the result is OK
7-76
8
Maintaining your analyzer
8.1 General Guidelines Maintenance Period
Content of Maintenance
Every day
If you are to use the analyzer 24 hours a day, be sure to perform the “probe cleanser cleaning” procedure everyday. To get reliable result, run QC program everyday before sample test. See chapter 8 QC in operation manual for details.
Every week
If you shut down your analyzer every day and follow the specified shutdown procedure to do that, you need to perform the “Probe cleanser cleaning” procedure every week.
As needed
When you think the baths might be contaminated, perform the “Clean the baths” procedure. For closed tube model, the tube baffle should be cleaned regularly to avoid possible biohazards. See Cleaning the Tube Baffle in operation manual. When the analyzer reports bubbles in volumetric tubes frequently, you need to check if the air filters are covered by dust; if so, please replace the air filters. For closed tube model, it is recommended that you change the pierce needle whenever 30,000 samples have been analyzed. When this analyzer is not to be used for two weeks, be sure to perform the “Prepare to ship” procedure to empty and wash the fluidic lines and then wipe the analyzer dry and wrap it up for storage. If you see other error messages, see chapter troubleshooting in operation manual, for solutions.
8-1
Maintaining your analyzer
8.2 Operation guidance of Quality Control and Calibration 8.2.1 Quality control Mindray recommends you run the QC program daily with low, normal and high level controls. A new lot of controls should be analyzed in parallel with the current lot prior to their expiration dates. This may be accomplished by running the new lot of controls twice a day for five days using any empty QC files. The QC files calculate the mean, standard deviation and coefficient of variation for each selected parameter. The instrument-calculated means of these ten runs should be within the expected ranges published by the manufacturer. See Chapter Using the QC programs in operation manual.
8.2.2 Calibration Calibration is a procedure to standardize the analyzer by determining its deviation under certain specified conditions. In order to get accurate sample analysis results, you should calibrate the analyzer per the procedure below when necessary. See Chapter Using the calibration programs in operation manual.
8.2.3 Guidance for mixing skills of Mindray controls and calibrations Daily storing It is recommended that controls and calibrations are stored in refrigerator with temperature 2~8℃. Notes 1. Only use the controls and calibrations within expiry date. After being taken out of the refrigerator, the controls and calibrations should be placed in environment with room temperature for 15mins before mixed or used. 2. Mark the open-box date on the package bottle of those new lots of controls and calibrations. Mixing skills After placing the controls and calibrations for 15mins, mix them as followings. Mixing time for each tube should be NOT less than 5mins with enough time for each step. 1. Tube heads upward. Rub the tube with two hands in low speed, for 1.5~2mins.
Figure 8-1 Tube top upward
8-2
Maintaining your analyzer 2. Tube heads downward. Rub the tube with two hands in low speed, for 1.5~2mins.
Figure 8-2 Tube top downward 3. Make tube parallel to the ground, and rub the tube with two hands in low speed, for 1.5~2mins.
Figure 8-3 Tube placed horizontally 4. Place the tube in headstand after mixing to check the result. Mix the controls and calibrations until reaching the following standard.
Good result. There is no clot or black residue.
Bad result. The bottom is covered by clot and black residue.
Figure 8-4 Comparison of well mixed sample and poorly mixed sample 5. Cap the tube well after each test of controls or calibrations to ensure their stability. 6. After mixing well, you need only to shake the controls or calibrations slightly before each test. 7. After a group tests or being placed for more than 5mins, controls or calibrations should be mixed as well as STEP 4 before they are use again.
8-3
Maintaining your analyzer NOTES 1. Put the controls and calibrations back to the refrigerator for more than 1 hour after using. 2. NOT place the controls and calibrations uncapped during the whole process, in case that the evaporation impacts the result. 3. During the breaks of a group of tests, you need only to shake the controls or calibrations slightly, in case that severe shaking impacts the result. 4. After opened, the period of validity is 14 days for controls is and 7 days for calibrations in refrigeration environment. Controls and calibrations out of period of validity are prohibited to use again.
8-4
9
Error Information
9.1 Error Information and Code Error Name X direction movement error of the sampling assembly Y direction movement error of the sampling assembly
Error code
Error Name
Error code
0x30000200
Vacuum is out of the range
0x30000603
Building pressure is not 0x30000204
allowed in the vacuum
0x30000621
chamber.
Steps error occurs when sampling assembly adjusts in
0x30000221
WBC clog
0x30000700
the X direction Steps error occurs when sampling assembly adjusts in
WBC bubbles (liquid 0x30000224
the Y direction Sampling assembly is working. Sampling assembly X motor movement overtime Sampling assembly action forbidden Sampling assembly Y motor movement overtime Sampling assembly action forbidden Sampling assembly Y motor piercing error ASP/LS syringe fails to find the home position
remains in the volumetric
0x30000701
tube) 0x30000227
RBC clog
0x30000702
RBC bubbles (liquid 0x30000228
remains in the volumetric
0x30000703
tube) 0x30000229 0x3000022B 0x3000022C 0x3000022E 0x30000300
HGB blank voltage abnormal HGB value abnormal Temperature out of the operating range No rinse (hardware reported) No rinse (reported by software) No diluent (reported by
0x30000720 0x30000721 0x30000500 0x30000521 0x3000052A
ASP/LS motor is working
0x30000320
ASP/LS motor action failure 1
0x30000321
ASP/LS motor action failure 2
0x30000322
Waste container is full.
0x30000528
0x30000323
Diluent expired
0x30000A01
0x30000324
Rinse expired
0x30000A02
0x30000325
Lyse expired
0x30000A03
Action 1 is not allowed by ASP/LS motor. Action 2 is not allowed by ASP/LS motor. ASP/LS motor action overtime
9-1
software) No lyse (reported by software)
0x30000523 0x30000525
Error Information DIL syringe fails to find the
0x30000301
Reagent kit expired
0x30000A05
DIL motor is working.
0x30000326
56V voltage abnormal
0x30000540
DIL motor action failure 1
0x30000327
DIL motor action failure 2
0x30000328
home position.
Aspiration and draining action 1 is not allowed by DIL motor. Aspiration and draining action 2 is not allowed by DIL motor. DIL motor action overtime Sample compartment
0x30000329 0x3000032A 0x3000032B
12V analogue voltage abnormal -12V analogue voltage abnormal 24V power voltage abnormal 12V power voltage abnormal Driver board 5V voltage abnormal
0x30000541 0x30000542 0x30000543 0x30000544 0x30000545
0x30000400
Printer out of paper
0x30000B00
0x30000403
Other errors of the printer
0x30000B02
0x30000420
Recorder out of paper
0x30000C00
0x30000421
Recorder overheat
0x30000C02
0x30000423
Recorder fails to respond.
0x30000C03
Building pressure error
0x30000600
Data communication error
0x30000D00
Pressure out of range
0x30000602
Front cover is opened.
0x30000580
0x30000620
Background abnormal
0x30000A00
movement error Sample compartment micro-switch error Sample compartment is not in the close position Sample compartment motor is working. Sample compartment action overtime
Building pressure is not allowed in the pressure chamber. Building vacuum error
0x30000601
9.2 Error analysis and processing If Remove Error does not work in the following error mode, check and deal with the errors as instructed in the following table.
9.2.1 Vacuum and Pressure errors Error Name
Causes analysis
Troubleshooting
9-2
Error Information 1. The vacuum pump is abnormal, check if the pump is working when building the pressure and whether there is air leakage in the pump. When the time for
2. Check if there is air leakage in the vacuum chamber.
Building
building pressure in the
3. Check if there is air leakage in the tubes, valve and
vacuum
vacuum chamber is up,
volumetric tube connected to the vacuum chamber or
error
the final pressure value
vacuum pump.
is lower than expected.
4. Check whether the pressure sensor and its tubing on the volumetric board are normal. 5. If the problem persists, consider to change the volumetric board or driver board. 1. The vacuum pump is abnormal, check if the pump is working when building the pressure and whether there is air leakage in the pump.
Vacuum is out of the range
The pressure value in the vacuum chamber checked is out of the assigned range.
2. Check if there is air leakage in the vacuum chamber. 3. Check if there is air leakage in the tubing, valve and volumetric tube connected to the vacuum chamber or vacuum pump. 4. Check whether the pressure sensor and its tubing on the volumetric board are normal. 5. If the problem persists, consider to change the volumetric board or driver board.
Building pressure is not allowed in the vacuum
Instruction collision when building pressure
Change driver board or data board.
in the vacuum chamber
chamber. 1. The pressure pump is abnormal, check if the pump is working when building the pressure and whether air leakage exists in the pump and pressure filter. When the time for
2. Check if there is air leakage in the pressure
Building
building pressure in the
chamber.
pressure
pressure chamber is up,
3. Check if there is air leakage in the tubing and valve
error
the final pressure value
connected to the pressure chamber or pressure pump.
is lower than expected.
4. Check whether the pressure sensor and its tubing on the volumetric board are normal. 5. If the problem persists, consider to change the volumetric board or driver board.
The pressure value in Pressure
the pressure chamber
out of range
checked is out of the assigned range.
1. The pressure pump is abnormal, check if the pump is working when building the pressure and whether air leakage exists in the pump and pressure filter. 2. Check if there is air leakage in the pressure chamber. 9-3
Error Information 3. Check if there is air leakage in the tubing and valve connected to the pressure chamber or pressure pump. 4. Check whether the pressure sensor and its tubing on the volumetric board are normal. 5. If the problem persists, consider to change the volumetric board or driver board. Building pressure is not allowed in the pressure
Instruction collision when building pressure
Change driver board or data board.
in the pressure chamber
chamber.
9.2.2 Reagent errors Error Name
Causes
Troubleshooting
analysis
1. Check if there are reagents in the rinse reagent bottle. 2. If there is enough amount in the reagent bottle, check the bubble number in the rinse The tubing
tubing. If there are many bubbles, check if there
No rinse (hardware
status checked
is air leakage in the rinse tubing.
reported)
in assigned time
3. If there is no bubble in the tubing, then
is empty.
calibrate the rinse photocoupler again; see section 2.4.2 for the methods. 4. If the problem persists after the calibration of the rinse photocoupler, check the photocoupler or driver board and change the ineffective parts.
No rinse (reported by software) No diluent (reported by software) No lyse (reported by software)
The residual amount is lower than 5%. The residual amount is lower than 5%. The residual amount is lower than 5%.
Change for new reagents or change the residual amount of the reagent. Change for new reagents or change the residual amount of the reagent. Change for new reagents or change the residual amount of the reagent. If the error is still reported when the waste
Waste container is full.
The dobber has already floated.
container is not full: 1. Check if the waste sensor inlet is connected reliably to the BNC connector at the back of the analyzer. 9-4
Error Information 2. Take the dobber out of the waste container to see if the dobber drops reliably. Expiration date Diluent expired
Change for new reagent or change the
is out of the set
expiration date.
range. Expiration date Rinse expired
Change for new reagent or change the
is out of the set
expiration date.
range. Expiration date Lyse expired
Change for new reagent or change the
is out of the set
expiration date.
range. Expiration date Reagent kit expired
Change for new reagent or change the
is out of the set
expiration date.
range.
9.2.3 Hardware errors Error Name X direction movement error of the sampling assembly Y direction movement error of the sampling assembly
Causes analysis
Troubleshooting
X direction motor photocoupler error, or the
1. Check whether the photocoupler is normal.
motor fails to run to the
2. Check if the motor and drive assembly miss
photocoupler due to missing
the steps or are resisted.
steps or being resisted. Y direction motor photocoupler error, or the
1. Check whether the photocoupler is normal.
motor fails to run to the
2. Check if the motor and drive assembly miss
photocoupler due to missing
the steps or are resisted.
steps or being resisted.
Steps error occurs when sampling
The adjusted steps in X
assembly
direction exceed the limit.
Adjust again
adjusts in the X direction Steps error occurs when sampling
The adjusted steps in Y
assembly
direction exceed the limit.
Adjust again
adjusts in the Y direction Sampling assembly is working.
Control instruction collision of the sampling assembly
9-5
Change driver board or data board.
Error Information Sampling assembly X motor movement
X motor actual action
Change driver board or data board.
overtime
overtime Sampling assembly action forbidden
When the sampling assembly
1. Check whether the photocoupler is normal.
is working, the X motor is not
2. Check if the motor and drive assembly miss
in the allowed position.
the steps or are resisted.
Sampling assembly Y motor movement
Y motor actual movement
Change driver board or data board.
overtime
overtime Sampling assembly action forbidden
When the sampling assembly
1. Check whether the photocoupler is normal.
is working, the Y motor is not
2. Check if the motor and drive assembly miss
in the allowed position.
steps or are resisted.
Sampling
When Y motor is piercing, the
assembly Y
baffle fails to pass the piercing
motor piercing
center of the photocoupler
error
area.
1. Check whether the photocoupler is normal. 2. Check the piercing action of the sample probe.
ASP motor photocoupler ASP/LS syringe fails to find the home position.
error, or the motor fails to run to the photocoupler position for missing steps or the motor cannot drive the sample
1. Check whether the photocoupler is normal. 2. Check if the motor and drive assembly miss steps or are resisted.
probe to pierce the cap. ASP/LS motor
Control instruction collision of
is working.
the ASP motor
Change driver board or data board.
After the movement: The moving steps of the ASP ASP/LS motor
motor displayed that it shall
action failure 1
be in the photocoupler area,
1. Check whether the photocoupler is normal. 2. Check if the motor and drive assembly miss steps or are resisted.
and the photocoupler is not blocked. After the movement: The moving steps of the ASP ASP/LS motor
motor displayed that it shall
action failure 2
not be in the photocoupler
1. Check whether the photocoupler is normal. 2. Check if the motor and drive assembly miss steps or are resisted.
area, but the photocoupler is blocked. Action 1 is not
Before the movement: The
1. Check whether the photocoupler is normal.
allowed by
moving steps of the ASP
2. Check if the motor and drive assembly miss 9-6
Error Information ASP/LS motor.
motor displayed that it shall
steps or are resisted.
be in the photocoupler area, and the photocoupler is not blocked. Before the movement: The Action 2 is not allowed by ASP/LS motor.
moving steps of the ASP
1. Check whether the photocoupler is normal.
motor displayed that it shall
2. Check if the motor and drive assembly miss
not be in the photocoupler
steps or are resisted.
area, but the photocoupler is blocked.
ASP/LS motor movement overtime
ASP motor actual movement overtime
Change driver board or data board.
DIL motor photocoupler error, DIL syringe fails to find the home position.
or the motor fails to run to the photocoupler position for
1. Check whether the photocoupler is normal. 2. Check if the motor and drive assembly miss
missing steps or the motor
steps or are resisted.
cannot drive the sample probe to pierce the cap.
DIL motor is
Control instruction collision of
working.
the DIL motor
Change driver board or data board.
After the movement: The DIL motor action failure 1
moving steps of the DIL motor
1. Check whether the photocoupler is normal.
displayed that it shall be in the
2. Check if the motor and drive assembly miss
photocoupler area, and the
steps or are resisted.
photocoupler is not blocked. After the movement: The DIL motor action failure 2
moving steps of the DIL motor
1. Check whether the photocoupler is normal.
displayed that it shall not be in
2. Check if the motor and drive assembly miss
the photocoupler area, but the
steps or are resisted.
photocoupler is blocked. Aspiration and draining action 1 is not allowed by DIL motor. Aspiration and draining action 2 is not allowed by DIL motor. DIL motor movement overtime
Before the movement: The moving steps of the DIL motor
1. Check whether the photocoupler is normal.
displayed that it shall be in the
2. Check if the motor and drive assembly miss
photocoupler area, and the
steps or are resisted.
photocoupler is not blocked. Before the movement: The moving steps of the DIL motor
1. Check whether the photocoupler is normal.
displayed that it shall not be in
2. Check if the motor and drive assembly miss
the photocoupler area, but the
steps or are resisted.
photocoupler is blocked. X motor actual movement
Change driver board or data board.
overtime
9-7
Error Information Photocoupler error of the close position of the sample
Sample
1. Check whether the photocoupler is normal.
compartment, or the sample
compartment movement error
compartment misses steps or fails drive the sample probe to
2. Check if the motor and drive assembly miss steps or are resisted.
pierce the cap. Sample
Micro-switch error or the
compartment
sample compartment closes
micro-switch
when the adapter is not
error
placed.
Sample compartment is not in the close position Sample compartment motor is working.
1. Check if the adapter is placed in the correct position. 2. Check whether the micro-switch is normal.
When the sampling assembly is moving downward at the
1. Check whether the photocoupler is normal. 2. Check whether the micro-switch is normal.
aspirating position, the
3. Check whether the sample compartment is
sample compartment does
pressed and closed reliably when closes.
not close. Control instruction collision of the sample compartment
Change driver board or data board.
motor
Sample compartment
Sample compartment motor
movement
actual movement overtime
Change driver board or data board.
overtime Recorder out of paper
Recorder out of paper or the recorder paper is not positioned in the right place
Recorder
Recorder thermal head
overheat
overheat
Recorder fails to respond.
Install new recorder paper. Continuous printing time is too long; the problem is removed when it is cooled down and prints again.
Abnormal recorder driver board, thermal head or cables and so on
Check whether the recorder and cables are normal.
The front cover is opened or
1. Check if the front cover is closed.
Front cover is
the connecting line of the front
2. If the problem persists when the front cover
opened.
cover detecting sensor is
is closed, then check whether the connecting
damaged.
line of the sensor is reliable.
9.2.4 Voltage errors Error Name
Causes analysis
56V voltage
The voltage detected is
abnormal
out of range
Troubleshooting 1. Check whether the 56V test point on the data board is normal. 2. Check whether the analogue +12V test point on the 9-8
Error Information data board is normal. 3. Remove J4 from the data board; check whether the analogue 12V voltage from the power supply is normal. 4. Change the data board or power supply board based on the checking results. 1. Check whether the analogue +12V test point on the data board is normal.
12V analogue
The voltage detected is
voltage
out of range
abnormal
2. Remove J4 from the data board; check whether the analogue +12V voltage from the power supply is normal. 3. Change the data board or power supply board based on the checking results. 1. Check whether the analogue -12V test point on the data board is normal.
-12V analogue
The voltage detected is
voltage
out of range
abnormal
2. Remove J4 from the data board; check whether the analogue -12V voltage from the power supply is normal. 3. Change the data board or power supply board based on the checking results. 1. Check the whether 24V test point on the driver
24V power voltage abnormal
board is normal. The voltage detected is
2. Remove J5 from the data board; check whether the
out of range
24V voltage from the power supply is normal. 3. Change the driver board or power supply board based on the checking results. 1. Check whether the 12V test point on the driver
12V power voltage abnormal
board is normal. The voltage detected is
2. Remove J5 from the data board; check whether the
out of range
12V voltage from the power supply is normal. 3. Change the driver board or power supply board based on the checking results. 1. Check whether the 5V test point on the driver board
Driver board 5V voltage abnormal
is normal. The voltage detected is
2. Remove J4 from the data board; check whether the
out of range
5V voltage from the power supply is normal. 3. Change the driver board or power supply board based on the checking results.
9.2.5 Measurement errors Error Name
Causes analysis
Troubleshooting
9-9
Error Information 1. Check whether the reagents are connected correctly. Especially note that whether the waste is connected to the reagent inlet. 2. Perform background counting after all the reagents are changed. 3. If the problem persists, open the front cover and Background
Background out of
shielding box, and then perform background counting.
abnormal
range
Observe whether the fluid dispensing of WBC and RBC bath are normal, if the charging tube or sample probe build many small bubbles into the bath, then check the error of the tubing and the sample probe.(Note: Before the photocoupler of the volumetric tube is triggered, close the cover of the shielding box). 4. Check the shielding structure of the bath. 1. Ensure the HGB assembly lighting source lightens, the fluidic level covers the HGB light, and then adjust the gain in the gain adjusting screen, the HGB blank
HGB blank
HGB blank voltage
voltage is 4.5±0.1V.
voltage
not within the range
2. Check whether the fluid dispensing of WBC bath is
abnormal
of [3.2V,4.9V]
normal; ensure that there are no abnormal conditions such as insufficient fluids and building bubbles. 3. If the problem persists after the above checking, then change the HGB assembly. 1. Ensure the HGB assembly lighting source lightens, the fluidic level covers the HGB light, and then adjust the gain in the gain adjusting screen, the HGB blank
HGB value
The output HGB
abnormal
value is lower than 0.
voltage is 4.5±0.1V. 2. Check whether the fluid dispensing of WBC bath is normal; ensure that there are no abnormal conditions such as insufficient fluids and building bubbles. 3. If the problem persists after the above checking, then change the HGB assembly. 1. Enter the maintenance screen, zap and flush for
The triggering time of the first WBC WBC clog
photocoupler or the count time is too long
more than 3 times. 2. If the problem persists, then soak with the probe cleanser. 3. If the problem persists, check if there is air leakage in the tubing from the back bath to the volumetric tube. 4. If the problem persists, then remove the aperture; check whether the aperture is clogged.
WBC bubbles
The triggering time
1. Check whether liquid remains in the volumetric tube.
(liquid remains
of the first WBC
2. Check whether there is air leakage in the volumetric
in the
photocoupler or the
tube and the tee connector which enable the bubbles
volumetric
count time is too
to get into the volumetric tube. 9-10
Error Information tube)
short. The triggering time of the first RBC
RBC clog
photocoupler or the
Use the same troubleshooting method as WBC clog
count time is too long. RBC bubbles
The triggering time
(liquid remains
of the first RBC
in the
photocoupler or the
volumetric
count time is too
tube)
short.
Use the same troubleshooting method as WBC bubbles
9.2.6 External connection errors Error Name
Causes analysis Printer out of paper or
Printer out of
improper printing paper
paper
placing
Other errors
Status of the printer is
of the printer
abnormal
Troubleshooting Place in the printing paper again, trigger the printer to go on printing (Different operations are used by different models of the printers, see the printer operator's manual for details). Check whether the status of the printer is normal and remove relevant errors. (see the printer operator's manual for details)
9.2.7 Temperature errors Error Name Temperature out of operating range
Causes analysis The temperature detected by the temperature sensor is out of the operating range.
Troubleshooting 1. Check whether the temperature shown by the device matches the real temperature. 2. Check whether the cables and connectors of the temperature sensor are normal. 3. If the problem persists, then change the driver board.
9.2.8 Software errors Error Name
Causes analysis
Troubleshooting 1. Check whether correct cable connections
Data
Abnormal connection
(network cable/serial port wire) are used between
communication
or incorrect
the LIS computer and the main unit.
error
communication setting
2. Check whether the LIS software is corresponding to the communication setting of the main unit. 9-11
Error Information
9.3 Error diagnosis assisted by abnormal histogram Note: The following figures are got from the R & D debug platform and are only used to assist the error diagnosis with the help of the histograms.
9.3.1 WBC histogram diagnosis Comparison of normal and abnormal WBC histogram: WBC histogram of normal sample is as shown in Figure 9- 1, the three-part differentiate is clear, and the WBC value is 7.1.
Figure 9-1 Normal WBC histogram If the lyse reaction is abnormal in the WBC channel, the shape of the WBC histogram varies as shown in the following Figure 9-2.
Figure 9-2 WBC histogram of abnormal blood
Possible causes analysis: The error shown in Figure 9-2 occurs because WBC fails to generate bubbles in the lyse reaction phase. The WBC fails to react fully because of no generation of bubbles, and creates main peak in the 50~100fL channel, the WBC particles which are not fully reacted and part of the RBCs which are not sufficiently lysed. The statistics shows that the WBC value is 34.6.
Key point of maintenance and repair: 9-12
Error Information Observe the variation of the WBC histogram. If the peak of the histogram moves slightly to the right, generally it is because of insufficient reaction, check whether the adding of reagents in WBC bath is normal, or change for another batch of reagents. If the WBC histogram varies seriously,it is possibly caused by insufficient lyse, check the adding of reagents, and also relevant factors such as the mixing up the WBC bath, liquid level of the front bath, bubbles in the back bath and so on.
9.3.2 RBC/PLT histogram diagnosis Comparison of normal and abnormal RBC/PLT histogram:
Figure 9-3 Normal RBC/PLT histogram
Figure 9-4 Abnormal RBC/PLT histogram
Possible causes analysis: If there are many bubbles in the RBC back bath, the histogram of abnormal data may be got as shown. The bubbles of back bath may be caused by the following reasons: 1. There is insufficient fluid in the RBC bath, when the samples flow by the aperture, the fluid level is lower than the aperture, so that the RBC back bath aspirates the bubbles from the front bath. 2. There is air leakage in the back bath; bubbles are aspirated through the gap of the assembly when counting. 3. The back bath is not cleaned thoroughly because of the valve error; the bubbles generated by zapping gather in the back bath and fail to be flushed away. Meanwhile, the pulse signals are totally irregular and the baseline disappears, the RBC histogram is totally abnormal, the main PLT area of PLT histogram uplifts.
Key point of maintenance and repair: 1. Observe the fluid level of the front bath carefully. 2. Observe whether the bubbles are flushed away when cleaning the back bath. 9-13
Error Information
9.3.3 Histogram examples of typical samples The numbers in the following histogram indicate relevant position of the discriminator. The numbers do not carry the unit fL; the histograms are only used for reference.
1. Normal sample Parameter result
Histogram
Figure 9-5 Histogram of normal sample
2. Iron deficiency anemia Parameter result
Histogram
Figure 9-6 Histogram of iron deficiency anemia sample
9-14
Error Information
3. Hemolytic anemia Parameter result
Histogram
Figure 9-7 Histogram of hemolytic anemia sample
4. Acute lymphoblastic leukemia Parameter result
Histogram
Figure 9-8 Histogram of acute lymphoblastic leukemia sample
9-15
Error Information
5. Acute promyelocytic leukemia (M3, granulocyte polymorpho nuclear which causes the histogram of the granulocytes shifts to the left) Parameter result
Histogram
R3
Figure 9-9 Histogram of acute promyelocytic leukemia sample
6. Acute monocytic leukemia (M5b) Parameter result
Histogram
R2R3Rm
Figure 9-10 Histogram of acute monocytic leukemia sample
9-16
Error Information
7. Chronic myelocytic leukemia, (CML) Parameter result
Histogram
R2R3R4Rm
Figure 9-11 Histogram of chronic myelocytic leukemia sample
8. Acute megakaryocytic leukemia (M7) Parameter result
Histogram
R2R3Rm
Figure 9-12 Histogram of acute megakaryocytic leukemia sample
9-17
Error Information
9. During the treatment of chronic myelocytic leukemia--interference of nucleated red blood cells (NRBCs) Parameter result
Histogram
R1R3Rm
Pm Figure 9-13 Histogram of the chronic myelocytic leukemia sample during the treatment with interference of NRBC
10. Reason for leukopenia-inteference of RBC debris Parameter result
Histogram
Pm Pl Figure 9-14 Reason for leucopenia - Histogram with interference of RBC debris
9-18
Error Information
11. Thrombocytosis Parameter result
Histogram
Figure 9-15 Histogram of thrombocytosis
12. Acute myeloblastic leukemia -partial maturity (transferred from MDS) Parameter result
Histogram
R1R2R3Rm
Figure 9-16 Histogram of sample of acute myeloblastic leukemia-partial maturity
9-19
Error Information
13. Neutrophil granulocyte increases Parameter result
Histogram
Figure 9-17 Histogram of neutrophil granulocyte increase sample
14. Lymphocytosis Parameter result
Histogram
R3
Pm Figure 9-18Histogram of lymphocytosis sample
9-20
Error Information
15. Monocytosis Parameter result
Histogram
R2R3Rm
Figure 9-19 Histogram of monocytosis sample
9.4 Error diagnosis assisted by abnormal pulse figure The browse function of the present sample pulse of the system helps the analyzer a lot to diagnose the complicated errors.
9-21
Error Information
9.4.1 Pulse of background count
Figure 9-20 WBC pulse of background count
Figure 9-21
RBC pulse of background count
9-22
Error Information
Figure 9-22
PLT pulse of background count
When the background is clean, most part of the channels of background count is saturated pulse formed by the small bubbles as shown in the above figure. Only a small quantity of particles scatter everywhere in the pulse figure.
9.4.2 Pulse of normal sample
Figure 9-23 WBC pulse of normal sample 9-23
Error Information
Figure 9-24
RBC pulse of normal sample
Figure 9-25
RBC pulse of normal sample
In normal condition, the pulse width of WBC, RBC and PLT are generally consistent, but the pulse peak of WBC is distributed unevenly, while the pulse heights of RBC are distributed consistently, and the pulse peak of PLT is the lowest. When refer to the pulse spacing, the pulse distribution of WBC are sparse, while the RBC distribution is dense, the PLT is generally scattered between other pulses.
9-24
Error Information
9.4.3 Interference pulse
Figure 9-26 WBC interference of background count
Figure 9-27
RBC interference of background count
Figure 9-28 WBC interference of background count The above figure shows the interference pulses of each channel when the shielding of the bath is ineffective. Feature: The shapes of the pulses are irregular, the pulses overlap a lot, and the pulse width is narrow, while the heights are distributed unevenly.
9-25
Error Information
9.4.4 Pulse of back bath of no fluid
Figure 9-29
RBC pulse when there is no fluid in the back bath
Figure 9-30 PLT pulse when there is no fluid in the back bath When there is no fluid at the back bath or when a lot of bubbles are aspirated, the RBC/PLT signal baseline will disappear; in the meantime, the pulse will be fully saturated.
9-26
10 A
Appendices
List of Spare Parts
Please provide the code and name of the MINDRAY spare parts listed in this manual when you order and purchase spare parts from MINDRAY. This will help us offer you the spare parts you need as soon as possible. Choosing spare parts by MINDRAY will ensure the perfect working state of you analyzer.
A.1 List of Spare PCBA No.
Description
MINDRAY
Remark
code/model 1
Power supply board
801-3007-00001-00
2
Data board
801-3007-00002-00
3
Driver board
801-3007-00003-00
4
Touchscreen control board
801-3007-00004-00
5
Indicator board
801-3007-00005-00
6
Recorder driver board
801-3007-00006-00
7
USB interface board
801-3007-00007-00
8
Volumetric board
801-3007-00008-00
9
Sample compartment connecting board
801-3007-00009-00
only applicable to closed tube model
A.2 List of Spare parts No.
Description
MINDRAY code/model
1
Touchscreen
801-3900-00037-00
2
CF card with software
801-3007-00010-00
3
Screen assembly
801-3007-00011-00
4
Recorder assembly
801-3007-00012-00
5
Power supply assembly
801-3007-00013-00
6
HGB assembly
801-3900-00041-00
7 8 9 10
801-3900-00061-00 Front cover door detect assembly Photocoupler and connecting cable
801-3900-00039-00
Liquid-level photocoupler and connecting cable
801-3900-00040-00
Sensor assembly of the syringe
801-3900-00059-00 A-1
Remark
Appendices motor 11
Micro-switch
801-3007-00014-00
12
WBC bath assembly
801-3900-00001-00
13
RBC bath assembly
801-3007-00015-00
14 15 16 17
WBC bath (without aperture) maintenance and repair part
801-3900-00003-00
RBC bath (without aperture) maintenance and repair part
801-3900-00004-00
WBC bath (without HGB unit) maintenance and repair part
801-3900-00005-00
Maintenance and repair part of bath washer
801-3900-00006-00
18
Tube kit under the bath
801-3007-00016-00
19
Aperture sensor (D80um)
801-2800-00013-00
20
RBC aperture (D70um)
801-3110-00078-00
21
HGB bath O-ring
801-3900-00095-00
22
Sampling assembly
801-3007-00017-00
23
Vertical action assembly
801-3007-00018-00
24
Horizontal action assembly
801-3007-00019-00
25 26 27 28
only applicable to Probe wipe clamp (Open vial)
801-3900-00013-00
only applicable to Probe wipe clamp (Closed tube)
801-3900-00014-00
Closed-tube sample probe
801-3900-00015-00
29
10ml syringe assembly
801-3900-00054-00
30
Single syringe drive assembly
801-3900-00053-00
31
10ml syringe
801-3900-00009-00
32
Double syringe assembly
801-3900-00051-00
33
Double syringe drive assembly
801-3900-00052-00
34
2.5ml syringe
801-3900-00007-00
37 38 39
open vial model only applicable to
801-3101-00002-00
36
closed tube model only applicable to
Open-vial sample probe
35
open vial model
closed tube model
100ul syringe maintenance and repair part Sample compartment assembly Sample compartment door for sales Sample compartment door for bidding Predilute adapter
801-3900-00008-00 801-3007-00020-00 801-3007-00021-00 801-3007-00022-00 801-3007-00023-00
A-2
only applicable to closed tube model only applicable to closed tube model only applicable to closed tube model only applicable to closed tube model
Appendices
40
Adapter assembly 1
801-3007-00024-00
41
Adapter assembly2
801-3007-00025-00
42
Probe wipe fixing pin
801-3900-00096-00
43 44 45
801-3007-00026-00
Aspirate key for sales
801-3007-00027-00
Aspirate key for bidding
801-3900-00094-00
46
Sample holder tighten assembly
801-3900-00046-00
47
Rinse cap assembly
801-3007-00028-00
48
Lyse cap assembly
801-3007-00029-00
49
Diluent cap assembly
801-2800-00018-00
Waste cap assembly (drain waste to waste container)
801-3900-00020-00
51
Tube bracket assembly
801-3007-00030-00
52
Fluidic pump assembly
801-3900-00022-00
53
Gas pump assembly
801-3007-00031-00
54
Shielding box assembly
801-3007-00032-00
55
Maintenance and repair par of volumetric tube
801-3101-00047-00
56
Waste pump filter assembly
801-3900-00024-00
57
Filter of the isolation chamber
801-3900-00010-00
58
Air filter
801-1805-00026-00
59
Pressure chamber assembly
801-1805-00006-00
60
Vacuum chamber assembly
801-1805-00005-00
61
Customized mini tee electromagnetic valve maintenance package
801-0030-00001-00
Customized Two-way mini 62
electromagnetic valve maintenance package
801-0030-00002-00
63
Back board connector package
801-3007-00033-00
64
Tubing package
801-3900-00083-00
65
Thick 50 tubing package
801-3900-00097-00
66
Thin 50 tubing package
801-3900-00098-00
67
1.5 TEFLON tube package
801-3900-00099-00
68
3603 thick tube package
801-3900-00100-00
69
MPF tube package
801-3900-00101-00
70
Middle silica gel tube package
801-3900-00102-00
71
closed tube model only applicable to closed tube model only applicable to open vial model only applicable to open vial model only applicable to
Tube barrier
50
only applicable to
Middle silica gel transferring tube package
801-3900-00103-00
A-3
closed tube model
Appendices 72 73
1.0 TEFLON tube package
801-3900-00104-00
Small silica gel transferring tube package
801-3900-00105-00
74
0.8 TEFLON tube package
801-3900-00106-00
75
Sampling tube package
801-3900-00107-00
76
Thick EVA tube package
801-3900-00108-00
77
Black transferring tube package
801-3900-00109-00
78
Thick TPU tube package
801-3900-00110-00
79
Cable package
801-3007-00034-00
80
Screw package
801-3007-00035-00
81
Connector package
801-3900-00092-00
82
Tools kit
801-3007-00036-00
83
On-site Maintenance Package
801-3007-00037-00
84 85 86 87
801-3007-00038-00
BC-3600 open vial cover
801-3007-00039-00
BC-3600 closed-tube cover
801-3007-00040-00
BC-3300 open vial cover
801-3007-00043-00
BC-3600 closed-tube cover
only applicable to open vial model only applicable to closed tube model only applicable to open vial model only applicable to closed tube model
A.3 Cable list No.
Description
MINDRAY
Bidding
no.
code/model
corresponding to appendix C
1
D5V/P12V/P24V power cord
009-001367-00
(1)
2
Zap power cord
009-001366-00
(2)
3
Data board A12V power cord
009-001368-00
(3)
Communication cable of the 4
volumetric board
3900-20-85357
(4)
Connecting wire harness of 5
the motor control (open vial)
009-001363-00
(5)
Connecting wire harness of the motor control (closed
(5)
6
tube)
009-001417-00
7
Safe ground wire of syringe
009-001195-00
Connecting wire harness of 8
valve control Pump
9
control
Connecting
wire Connecting
10
009-001376-00 009-001373-00 wire
temperature sensor
of 3900-20-85347
A-4
(6) (7) (8) (9)
Remark
Appendices Connecting wire harness of photocoupler signal (closed 11
tube)
009-001365-00
Connecting wire harness of 12
photocoupler
009-001412-00
Sample 13
compartment
micro-switch transferring wire Connecting
wire
of
009-001375-00
data
(10) (11) (12) (13)
14
board and power driver board
3900-20-85342
15
USB Connecting wire
009-001419-00
(14)
16
RBC signal wire
3900-20-85345
(15)
17
WBC signal wire
3900-20-85344
(16)
18
HGB signal wire
3900-20-85343
(17)
19
Connecting wire of recorder
3900-20-85341
(18)
20
Ground wire of recorder
009-001364-00
(19)
Signal detecting wire of door 21
opening
3900-20-85379
Connecting 22
wire
of
LCD
screen signal
009-001418-00
Signal wire of front cover 23
009-001369-00
assembly Ground wire of the screen
24
backboard Transferring
25
009-001374-00 wire
of
LCD
screen backlight board
2800-20-28768
Photocoupler and Connecting 26
wire (rinse detecting)
3900-21-85368
WIRE three-core power cord 27
509B-10-05996
of national standards
(20) (21) (22) (23) (24) (25) /
A.4 Consumable list No.
Description
MINDRAY code/model
1.
Thermal print paper of the recorder
A30-000001---
2.
Tubing package
801-3900-00083-00
3.
only Centrifugal tube (1.5ml)
A21-000013---
4.
Cellular sampling cup
A22-000005---
5.
Plastic test tube 12*100 (5ml)
A21-000012---
6.
Mindray
B30
controls
P
(high
0031-30-84473
Mindray B30 controls P (normal
0031-30-84476
level/3ml) 7.
Remark
level/3ml) A-5
applicable
closed tube model
to
Appendices 8.
Mindray
B30
controls
P
(low
0031-30-84479
level/3ml) 9.
Mindray S30 calibrators (3ml)
0031-30-84549
10.
Mindray M-30PD diluent (20L)
A12-000099---
11.
Mindray
M-30PCFL
cyanide-free
lyse (150ml) 12.
Mindray
A11-000079---
M-30PCFL
cyanide-free
lyse (250ml) 13.
Mindray
A12-000103--M-30PCFLcyanide-free
lyse (500ml)
A12-000104---
14.
Mindray rinse (5.5L*2)
A12-000107---
15.
Mindray probe cleanser (50ml)
105-000385-00
A-6
Appendices
B
List of Damageable and Consumable Parts
No.
Material name
MINDRAY code/model
Remark
801-3900-00013-00
only applicable open vial model
801-3900-00014-00
only applicable to closed tube model
Closed-tube sample probe
801-3900-00015-00
only applicable to closed tube model
Air filter
801-1805-00026-00
1 Probe wipe clamp (open vial) 2
Probe wipe clamp (closed tube)
3 4
B-1
to
Appendices
C
Electricity Connection Diagram of the Analyzer
Description of the electricity connection diagram of the analyzer 1) The dashes marked with ⑤ in the following diagram only indicates the connection of closed tube model, the real line marked with ⑤ indicates that the connections of the open vial model and closed tube model are the same; 2) The dashes marked with ⑩ in the following diagram only indicates the connection of close tube model, there is no such connection for the open vial model; 3) The dashes marked with
12
in the following diagram indicates the connection of closed
tube model; 4) The rest of the connections are the same for closed tube model and open vial model; 5) See Appendix A.3 for the details of the list of cable codes. 6) The electricity connection diagram of the analyzer is shown as follows.
C-1
Appendices
C-2
Appendices
D
Fluidic Diagram
D-1
Appendices
E
Pump and Valve Function Table
E.1 Fluidic Valve Function Table Description V01 V02 V03 V04
Function
2-way/3-way
Switching the aspirating and draining operations of the diluent syringe Providing diluent to probe wipe, connecting the diluent syringe with the probe wipe inlet when V02 is open Switching between aspiration and draining of the lyse Providing diluent to sample probe, connecting the diluent syringe with the sample probe when the V04 is open
3 3 3 3
V05
Draining the WBC volumetric tubes
2
V06
Draining the RBC volumetric tubes
2
V07
Use for the control of WBC count
2
V08
Use for the control of RBC count
2
V09 V10 V11 V13
Control the connection between the vacuum chamber and pressure chamber Control the connection between the pressure chamber and the isolation chamber of WBC bath, generate bubbles in the WBC bath Control the connection between the pressure chamber and the isolation chamber of RBC bath, generate bubbles in the RBC bath Adding diluent into the RBC bath, connecting the diluent syringe passage to the fluidic adding tube of RBC bath
2 2 2 3
V14
Control the washing of the WBC back bath together with V07
2
V15
Control the washing of the RBC back bath together with V08
2
V16 V17 V18 V19
Control the connection between isolation chamber and the waste pump, and drain the WBC bath Control the connection between isolation chamber and the waste pump, and drain the RBC bath Control the connection between vacuum chamber and the waste pump, use for building vacuum and draining the waste Control the draining of probe wipe waste
2 2 2 2
E.2 Pump Function Table Description Gas
pump
Function Building pressure in the pressure chamber, generating bubbles and flushing
(GP)
the aperture with the pressure
Waste pump
Draining the vacuum chamber and building vacuum in the vacuum chamber;
(LP)
Draining the waste in the WBC bath, RBC bath and the probe wipe.
E-1
Appendices
E.3 Syringe Function Table Description Sampling syringe (100ul) Lyse syringe (2.5ml) Diluent syringe (10ml)
Function Aspirating and dispensing sample Adding lyse to WBC bath Adding diluents to the WBC bath and the RBC bath, cleaning the sample probe and adding diluents to the probe wipe
E-2
Appendices
F
Tubing
F.1 Fluidic Disposition Chart C21
T47
DILUNET
T48
T2
RINSE
J5-T20J6 T49
SV2 SV1
J3-T56J4
SV13
T3 SV4
SV7
SV5
C26
J9-T64J10
T34
GF3
SV3
C4 T31
C16
T14
T15
T35
GF4
T53
Rinse container
SV6 T32 GF1 SV8 C15
C13
T13
T30
C3
T12
T33
T39
GF2
T54
Pressure sensor
Pressure sensor T50 T40
SPB
T85 T28
T68
T51
T79 T52
Volumetric tube 1
C27
PC
T80
LF
C1
VC
C23
C24
T81
T83
RBC bath
T88
T97
Probe wipe
C14
C22 T87
Rinse detectin g sensor
WBC bath
T82T84 C2
T67
C25
T66
SV14
SV15 T36
SV9 T11
T6
SV11 T10 T41
C18
T7
SV10
J1 C9 7
C2 8
C8 J19
T77
J21J22-T63-J24J23
Isolation chamber 1
C11
Waste interface
T99
C19
GF6
LP
T9
SV18
T70
T69
SV19
SV17
SV16
T29 T29
T27
T26 C7
Waste tank
C10
T78
T8
C17 T42 T43 GF5
C20 T38
J18-T62J20
T18
GP
T37
T86
T98
T22
T24 T25
C6
T23
C5
F-1
T21
Isolation chamber 2
Lyse bottl e
Appendices
F.2 Tubing Model MINDRAY
Position in the
code/model
fluidic chart
No.
Name
1
T1
M6G-020005---
A1
55
2
T2
M6G-020005---
A1
60
3
T3
M6G-020005---
A2
30
4
T4
M6G-020005---
B2
15
5
T5
M6G-020005---
B5
35
6
T6
M90-100071---
C1
160
7
T7
M90-100071---
C2
15
8
T8
M90-100071---
C1
50
9
T9
M90-100071---
C3
75
10
T10
M90-100071---
C1
15
11
T11
M90-100071---
C2
80
12
T12
3001-10-07069
B3
51
13
T13
3001-10-07069
B3
43
14
T14
3001-10-07069
B3
41
15
T15
3001-10-07069
B3
51
16
T16
M90-000025---
B3
38
17
T17
M90-000025---
C3
35
18
T18
M90-100071---
C3
45
19
T20
M90-100031---
A2
430
20
T21
M90-100071---
D4
120
21
T22
M90-100071---
D3
30
22
T23
M90-000025---
D3
40
23
T24
M90-100071---
D2
30
24
T25
M90-000025---
D2
40
25
T26
M90-100071---
D2
30
26
T27
M90-000025---
D2
160
27
T28
A21-000007---
C3
50
28
T29
M90-000025---
D1
90
29
T30
M90-100071---
B2
20
30
T31
M90-100071---
B2
20
31
T32
M90-100071---
B2
15
32
T33
M90-100071---
B2
15
33
T34
M90-100071---
B2
15
34
T35
M90-100071---
B2
15
35
T36
A21-000007---
C1
35
36
T37
M90-100071---
C5
20
37
T38
M90-100071---
C4
90
38
T39
M90-100071---
B5
300
39
T40
A21-000007---
C1
50
40
T41
A21-000007---
C1
30
F-2
Length (mm)
Appendices
41
T42
M90-100071---
C1
15
42
T43
M90-100071---
C1
15
43
T47
M90-100071---
A1
70
44
T48
M90-000025---
A4
280
45
T49
3001-10-07069
A5
400
46
T50
A21-000007---
C1
60
47
T51
A21-000007---
C1
30
48
T52
M90-100071---
C1
80
49
T53
3001-10-07069
B4
460
50
T54
3001-10-07069
B3
480
51
T55
M90-100031---
B2
950
52
T56
M90-100031---
A5
610
53
T57
M90-000025---
C6
300
54
T58
A21-000002---
B5
300
55
T60
A21-000002---
B5
180
56
T61
3001-10-07069
B1
830
57
T62
M90-000026
C3
500
58
T63
M90-000026
C4
500
59
T64
M90-100031---
A4
75
60
T65
M90-100031---
B4
80
61
T66
M90-100071---
C4
210
62
T67
M90-100071---
C3
240
63
T68
M90-100071---
C2
660
64
T69
M90-100071---
D3
160
65
T70
M90-100071---
D4
160
66
T72
M6G-020007---
B2
500
67
T73
0040-10-32301
B4
60
68
T74
M90-100031---
B4
60
69
T75
M90-100031---
B4
105
70
T76
M6G-020005---
A2
25
71
T77
M90-100071---
C4
110
72
T78
M90-100071---
C4
50
73
T79
M90-100071---
C1
200
74
T80
M90-100071---
C3
210
75
T81
3001-10-07069
C4
25
76
T82
3001-10-07069
C4
25
77
T83
M90-100071---
C4
15
78
T84
M90-100071---
C4
15
79
T85
3001-10-07069
C3
25
80
T86
3001-10-07069
C3
25
81
T87
M90-100071---
C3
15
82
T88
M90-100071---
C3
15
83
T89
M90-100031---
C4
120
F-3
Appendices
84
T90
M90-100031---
C4
120
85
T92
M6G-020054---
B6
1500
86
T93
M6G-020054---
A5
1000
87
T95
M6G-020055---
D1
1500
88
T97
M90-000025---
C2
70
89
T98
M90-000025---
C2
85
90
T99
M90-100071---
C2
120
F.3 Connector Models MINDRAY
Position in the
code/model
fluidic chart
C1
M90-100028---
C3
1
2
C2
M90-100028---
C4
1
3
C3
M90-100028---
B3
1
4
C4
M90-100028---
B3
1
5
C5
M90-100065---
D3
1
6
C6
M90-100065---
D2
1
7
C7
M90-100065---
D2
1
8
C8
M90-100028-01
C3
1
9
C9
M90-100028-01
C3
1
10
C10
M90-100028-01
C4
1
11
C11
M90-100028-01
C4
1
12
C13
M90-100027-00
B2
1
13
C14
3001-10-07066
C1
1
14
C15
M90-100028-03
B2
1
15
C16
M90-100028-03
B2
1
16
C17
M90-100028-03
C1
1
17
C18
M90-100028-03
C1
1
18
C19
M90-100028-03
C1
1
19
C20
M90-100028-03
C5
1
20
C21
M90-100027---
A2
1
21
C22
M90-100100---
C3
1
22
C23
M90-100100---
C3
1
23
C24
M90-100100---
C4
1
24
C25
M90-100100---
C4
1
25
C26
M90-100100---
B2
1
26
C27
M90-100027---
C2
1
27
C28
M90-100027---
C2
1
No.
Name
1
F-4
Amount
Appendices
F.4 Transferring Tube Models No.
Name
MINDRAY code/model
Position in the fluidic chart
Length (mm)
1
J1
082-000055-00
B2
20
2
J2
082-000055-00
B2
20
3
J3
082-000055-00
A5
20
4
J4
082-000055-00
A5
20
5
J5
082-000055-00
A2
20
6
J6
082-000055-00
A2
20
7
J7
082-000055-00
B4
20
8
J8
082-000055-00
B4
20
9
J9
082-000055-00
B4
20
10
J10
082-000055-00
B4
20
11
J11
082-000055-00
B4
20
12
J12
082-000055-00
B4
20
13
J13
M90-100071---
C4
50
14
J14
M90-100071---
C4
25
15
J15
M90-100071---
C4
50
16
J16
M90-100071---
C4
25
17
J17
M6G-020006---
C3
15
18
J18
M6G-020009---
C3
15
19
J19
M6G-020006---
C3
15
20
J20
M6G-020009---
C3
15
21
J21
M6G-020006---
C4
15
22
J22
M6G-020009---
C4
15
23
J23
M6G-020006---
C4
15
24
J24
M6G-020009---
C4
15
25
J25
2000-20-03314
B4
1
26
J26
2000-20-03314
B4
1
27
J27
2000-20-03314
B4
1
28
J28
2000-20-03314
C4
1
29
J29
2000-20-03314
C4
1
30
J30
2000-20-03314
C4
1
31
J31
2000-20-03314
C4
1
32
J32
0030-20-13339
B4
1
F-5
P/N: :046-001623-00( (1.0) )