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 ed 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: 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 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

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 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 s ····················································································· 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 -bracket Assembly ································································· 7-58

7.16

Front 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 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 ing 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, 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 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 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 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 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; s 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 s of service level and above.

2-5

Analyzer Structure The shutdown procedure will be performed according to different shutdown status.

2.2.7.2 and Management In order to protect the security of product setup and data, you have to possess the 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 s 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 s 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 s to modify certain configurations. E.g.: s can set up date/time, reference range, parameter unit, communication-related parameters, print format, etc.

3.

For the FDA model, s can set whether to display or print RUO parameters through the authorization protocol.

4.

For the FDA model, s can set "QC lockout", if this function is activated, sample analysis can be started only after the daily QC es.

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 s.

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 ed 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 The service ID is "Service", is "s 3600!", case sensitive and space required. With service access level, you can perform all functions that are open to common s 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 of the analyzer, click "OK" and then click "Finish", the dialog box "Priming rinse" will pop up, check the calibration status then: if "" 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.

"" 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 of service level, then a prompt will guide the 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、 s 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、 the BC-3600 with Service Engineer name and . 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, with the service engineer name and . 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 assembly

Side door of electrical system

5 --- Bottom 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 assembly

5 --- Bottom 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 assembly

7 --- Bottom 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 assembly

7 --- Bottom 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 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 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 ages 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 ages 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 age 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 age of draining of the WBC bath

V01 Diluent V04 V02

V03 2.5mL (SR1)

WBC bath

10mL （SR3）

lyse

Figure 5- 6 Fluidic age 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 ages 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 age 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 age 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 age 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 ages 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 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 "U＋FPGA", see Figure 6-7.The functions of the digital module are:

Preprocessing of data



ing 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 U), 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 U through Flexbus by means like interrupt, etc.

ing peripherals interfaces

The U 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 U 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 U 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 U

15

IRQ2

Interrupt signal when FPGA inputs to U

16

IRQ3

Interrupt signal when FPGA inputs to U

17

IRQ4

Interrupt signal when FPGA inputs to U

18

IRQ5

Interrupt signal when PCI-to-USB chip inputs to U

19

IRQ6

Interrupt signal when FPGA inputs to U

20

IRQ7

Interrupt signal when FPGA inputs to U

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 t on U6 weld, if yes, cut off the solder t when power is off. Reconnect the power, see if the error is cleared, if yes, the solder t failure can be concluded; if not, do step 4.

Cut

off

solder

the t

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 ed 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 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 , 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.

6-29

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 s 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 s 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.

6-32

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 s the status of analyzer through sound and light.

Figure 6-19 Indicator board

6-35

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.

6-36

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 the maintenance.

7-1

Servicing

7.2 Disassembling the s 7.2.1 Opening the Front Assembly Purpose：Bath Assembly and Sampling Assembly are located behind the Front , Screen Assembly and Recorder are located on the Front , to maintenance or disassemble the parts mentioned above, need to follow the procedures to open the Front 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 .

Figure 7-1 Opening the Front Assembly



Make sure the door of sample compartment is closed when opening the Front , or it may cause damage on the sample compartment and the Front .

Installation: Install the Front according to the steps stated above in reverse order. Verification: Pull the Front to check whether it’s locked tightly; Power on the analyzer and 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 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 Assembly Purpose: Follow the procedures to remove the Front 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 as per 7.2.1, unplug all cables connected between the Front 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 Assembly for about 5mm, and then take out the assembly.

7-5

Servicing

Figure 7-6 Removing the Front Installation: Install the Front 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 is locked tightly; 4. Power on the analyzer and 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 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 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 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 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 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 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 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 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 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 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 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 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 (as per section 7.2.3), Disassemble the lyse bottle and cap assembly. 4. Open the top (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 (as per section 7.2.3), Disassemble the lyse bottle and cap 7-21

Servicing

assembly. 4. Open the top (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 (as per section 7.2.3), Disassemble the lyse bottle and cap assembly. 4. Open the top (as per section 7.2.4); 5. Open the front 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 ; 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 (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 (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

Servicing

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 .



All the samples, controls, calibrators, reagents, wastes and areas ed 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 ed 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 .

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

Servicing

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 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 .

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

Servicing

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 assembly(as per section 7.2.1); 4. Open the right side (as per section 7.2.3)； 5. Open the top (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 .

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

Servicing

Removal: 1. Empty the liquid system; 2. Power off the instrument and unplug the power cable. 3. Open the front assembly(as per section 7.2.1); 4. Open the right side (as per section 7.2.3)； 5. Open the top (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 .

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

Servicing

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 .

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 assembly(as per section 7.2.1); 4. Open the right side (as per section 7.2.3)； 5. Open the top (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

Servicing

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 .

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 .

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 (as per section 7.2.4); 4. Open the right side (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

Servicing

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 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 .

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Servicing

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 assembly(as per section 7.2.1); 4. Open the top (as per section 7.2.4); 5. Open the right side (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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Servicing

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 (At this time, it’ll show “front 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 er 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 , remove the wipe block, and assemble the positioning calibration fixture of sample probe on the wipe block er 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”.

7-39

Servicing

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.

7-40

Servicing

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 .

All the samples, controls, calibrators, reagents, wastes and areas ed 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 ed 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 assembly(as per section 7.2.1); 4. Open the right side (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 , 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

7-42

Servicing

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 .



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 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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Servicing

Figure 7-43 Disassemble the horizontal movement assembly 1 ―――Sample probe assembly

2 ―――Fluidic assembly

tube



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 .

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 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

Servicing

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 .



All the samples, controls, calibrators, reagents, wastes and areas ed 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 ed 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 assembly(as per section 7.2.1); 7-45

Servicing

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 er, then push the probe wipe fixing pin to probe wipe along the underside of er, 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 .

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 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.

7-46

Servicing

Figure 7-46 Disassemble the probe wipe assembly 1 ―――Probe wipe fixing pin

3 ―――Probe wipe assembly

2 ―――Probe wipe er 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 .



All the samples, controls, calibrators, reagents, wastes and areas ed 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 ed 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

Servicing

1. 2. 3. 4.

5. 6. 7.

Empty the liquid system; Power off the instrument and unplug the power cable; Open the front assembly(as per section 7.2.1); Open the right side (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

3 ―――M3X8 screw



During disassembly and installation, please keep the sample probe always in upper position.

Installation: 7-48

Servicing

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 .(Refer to Section 7.12.2) Verification: 1. Check if all the cables(include motor) are connected well or not; 2. Close front , check the goodness of fit between the compartment door and front ; 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 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 er

3 ―――M3x8 screw

4―――M3x16 socket head screw

Installation: 7-49

Servicing

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 , move the door, make the upper gap and side gap almost same; 3. Open the front , 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 er; 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 , check the goodness of fit between the compartment door and front ; 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 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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Servicing

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 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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Servicing

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 assembly(as per section 7.2.1); 4. Open the right side (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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Servicing

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

Servicing

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 er 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 er.

Figure 7-54 Disassemble the open-close detecting switch 1 ―――Pan head screw M3X8

2 ―――open-close detecting switch

3 ―――er

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;

7-54

Servicing

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.

7-55

Servicing

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 assembly(as per section 7.2.1); 3. Open the right side (as per section 7.2.3), Disassemble the lyse bottle and cap assembly. 7-56

Servicing

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 , 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 , the related steps and notice as 7.2.1 indicates. 3. Open Right , 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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Servicing

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 , make sure it’s consistent.

7.15 Fluidic -bracket Assembly Purpose: Need replacement when the tubing -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 , 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 -bracket 1 ―――Sampling assembly

2―――Tubing -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 Detection Assembly Purpose: Detection assembly is used to detect if the front 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 , the steps and notice as 7.2.1 indicates. 3. Open the top , 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 detection assembly 1 ―――Front 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 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 , the steps and notice as 7.2.1 indicates. 3. Open the top , 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 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 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 . 7-61

Servicing



All the samples, controls, calibrators, reagents, wastes and areas ed 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 ed 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 , 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 )

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 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 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 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.

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 the result according to the specifications in the PRS 12. Calibrate in the predilute mode 13. Run the calibrator after finishing calibration, and 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.

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 the result according to the specifications in the PRS

7.

Calibrate in the predilute mode

8.

Run the calibrator after finishing calibration, and 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.

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 the result according to the specifications in the PRS

7.

Calibrate in the predilute mode

8.

Run the calibrator after finishing calibration, and 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. 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 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 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、 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 the result according to the specifications in the PRS 7、 、 Calibrate in the predilute mode 8、 Run the calibrator after finishing calibration, and 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、 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 the result according to the specifications in the PRS 7、 、 Calibrate in the predilute mode 8、 Run the calibrator after finishing calibration, and 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、 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 the result according to the specifications in the PRS 8、 、 Calibrate in the predilute mode 9、 、 Run the calibrator after finishing calibration, and 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)

the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and 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 the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and 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 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 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 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 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 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 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 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 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 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 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 7-70

Servicing 1、 Remove the BNC connector of the waste cap

22

Waste cap assembly (drain

assembly in the back , 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

the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and 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、 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

the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and 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 the result according to the specifications in the PRS 5、 、 Calibrate in the predilute mode 6、 Run the calibrator after finishing calibration, and 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 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 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

the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and 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 the result according to the specifications in the PRS 6、 、 Calibrate in the predilute mode 7、 Run the calibrator after finishing calibration, and 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 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 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 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 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 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 age 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） ）