BC-3600&3300 Service Manual V1.0

7/24/2019 BC-3600&3300 Service Manual V1.0

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BC-3600

BC-3300

Auto Hematology Analyzer

Service Manual


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I

Copyright

2008-2011 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.

For this Service Manual, the issued Date is 2011-02 (Version: 1.0).

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)

owns the intellectual property rights to this Mindray product and this manual. This manual may

refer to information protected by copyrights or patents and does not convey any license under

the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability

arising out of any infringements of patents or other rights of third parties.

Mindray intends to maintain the contents of this manual as confidential information. Disclosure

of the information in this manual in any manner whatsoever without the written permission of

Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rent, adaptation and translation of this

manual in any manner whatsoever without the written permission of Mindray is strictly

forbidden.

. , are the registered trademarks or trademarks owned by

Mindray in China and other countries. All other trademarks that appear in this manual are

used only for editorial purposes without the intention of improperly using them. They are the

property of their respective owners.

Responsibility on the Manufacturer Party

Contents of this manual are subject to changes without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable for

errors contained herein nor for incidental or consequential damages in connection with the

furnishing, performance, or use of this manual.

Mindray is responsible for safety, reliability and performance of this product only in the

condition that:

all installation operations, expansions, changes, modifications and repairs of this

product are conducted by Mindray authorized personnel;

the electrical installation of the relevant room complies with the applicable national


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and local requirements;

the product is used in accordance with the instructions for use.

This equipment must be operated by skilled/trained medicalprofessionals.

It is important for the hospital or organization that employs this equipment

to carry out a reasonable service/maintenanceplan. 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.


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III

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 PerformanceMindray is not responsible for the effects on safety, reliability and performance of BC-2800Vet,

if:

Assembly operations, extensions, re-adjusts, modifications or repairs are carried out

by persons other than those authorized by Mindray.

Personnel unauthorized by Mindray repairs or modifies the instrument.

Return Policy

Return Procedure

In the event that it becomes necessary to return this product or part of this product to Mindray,

the following procedure should be followed:

1. Obtain return authorization: Contact the Mindray Service Department and obtain a

Customer Service Authorization (Mindray) number. The Mindray number must appear

on the outside of the shipping container. Returned shipments will not be accepted ifthe Mindray number is not clearly visible. Please provide the model number, serial


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number, and a brief description of the reason for return;

2. Freight policy: The customer is responsible for freight charges when this product is

shipped to Mindray for service (this includes customs charges);

3. Return address: Please send the part(s) or equipment to the address offered by

Customer Service department.

Company Contact

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: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: Eiffestrae 80, 20537 Hamburg Germany

Phone: 0049-40-2513175

Fax: 0049-40-255726


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Table of Contents

CopyrightIIntellectual Property StatementI

Responsibility on the Manufacturer Party I

WarrantyIII

Exemptions III

Return Policy III

1 Using This Manual 1-1

1.1. Scope 1-2

1.2. Introduction 1-2

1.3. Conventions Used in This Manual 1-3

1.4. Special Terms Used in This Manual 1-3

1.5. Symbols 1-4

1.6. Definitions 1-12

2 Analyzer Structure 2-1

2.1 Product Name 2-1

2.2 System Introduction 2-1

2.3 System Composition 2-7

2.4 Software Structure 2-82.5 LIS Connection 2-19

3 Upgrade 3-1

3.1 Software upgrade 3-1

4 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

5 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

6 Hardware System 6-16.1 Introduction 6-1


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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

7 Servicing 7-1

7.1 General 7-1

7.2 Disassembling the Panels 7-2

7.3 Replacing the Hardware parts and Cable connection 7-6

7.4 Replacing the Power Supply Assembly 7-16

7.5 Replacing the Display Assembly 7-17

7.6 Replacing the Touch Screen 7-18

7.7 Replacing the Recorder Assembly 7-19

7.8 Replacing the valve, pumps, and other liquid system parts 7-20

7.9 Replacing the counting bath assembly 7-29

7.10 Replacing the syringe assembly 7-35

7.11 Replacing the sample probe assembly 7-37

7.12 Replacing the sample compartment assembly 7-47

7.13 Replacing the start key 7-56

7.14 Micro-Switch Assembly Replacement 7-57

7.15 Fluidic Support-bracket Assembly 7-58

7.16 Front Panel Detection Assembly 7-59

7.17 Ambient Temperature Sensor Replacement 7-60

7.18 Cap Assembly 7-61

7.19 Gain Adjustment 7-62

7.20 Motor Type, Position and Different Application List 7-64

7.21 The Check List After Material Replacement 7-64

8 Maintaining your analyzer 8-1

8.1 General Guidelines 8-18.2 Operation guidance of Quality Control and Calibration 8-2

9 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

10 Appendices A-1


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1-1

1 Using This Manual

This chapter explains how to use this service manual. This manual states in detail the way toservice 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.


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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

and BC-3300

Chapter 2 System Structure

learn about the installation requirements and the way to

upgrade the software of BC-3600 and BC-3300

Chapter 3 System Installation

and Software Upgrade

learn about the mechanical system structure of BC-3600 and

BC-3300

Chapter 4 Mechanical System

learn about the fluidic system, reagent dosage, channels and

basic sequence of BC-3600 and BC-3300

Chapter 5 Fluidic System

learn about the hardware system and board composition,

adjustment and test points and general troubleshooting

methods of BC-3600 and BC-3300

Chapter 6 Hardware System

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

BC-3600 and BC-3300

Chapter 9 Troubleshooting

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

BC-3300

Appendix B List of Wearing

Parts

learn about the circuit diagram of BC-3600 and BC-3300 Appendix C Circuit Diagramlearn about the schematic diagram of the fluidic system of Appendix D Fluidic Diagram


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BC-3600 and BC-3300

learn about the function of each valve and pump of BC-3600

and BC-3300

Appendix E Pump and Valve

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

italic letters indicate titles of the chapters that are referred

to

"Menu"the " " button on the screen.

All illustrations in this manual are provided as examples only. They may not necessarily reflect

your analyzer setup or data displayed.

1.4. Special Terms Used in This Manual

When you read It means

Clickto press the desired item lightly with your finger; or to

left-CLICK it with the mouse.

ENTER

to CLICKthe desired edit box and use the external keyboard

or the pop-up keyboard to enter the desired characters or

digits; or to scan the number by using the bar-code scanner.

DELETE

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

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 CLICKthe 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


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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.


alerting you to a possibility of analyzer damage or unreliable

analysis results.


alerting you to information that requires your attention.


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


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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


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not use the same fuse and protective switch with other equipment (e.g. life

supporting equipment). Otherwise, the equipment failure, over current or

impulse current that occurs at the startup moment may lead to tripping.

To prevent personal injury during maintenance, keep your clothes, hairs and

hands from the moving parts, such as sample probe, clipper and piercer.

Possible mechanical movement of the warned position may lead to personal

injury during the normal operation, removal and maintenance.

Be sure to dispose of reagents, waste, samples, consumables, etc.

according to government regulations.

The reagents are irritating to eyes, skin and mucosa. Wear proper personal

protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory

procedures when handling them in the laboratory.

If the reagents accidentally spill on your skin, wash them off with plenty of

water and if necessary, go see a doctor; if the reagents accidentally spill into

your eyes, wash them off with plenty of water and immediately go see a

doctor.

Improper maintenance may damage the analyzer. Maintain the analyzer

strictly as instructed by the service manual and inspect the analyzer

carefully after the maintenance.

For problems not mentioned in the service manual, contact Mindray

customer service department for maintenance advice.

To prevent personal injury or damage to equipment components, remove

metal jewelry before maintaining or servicing electronic components of the

equipment.

Electrostatic discharge may damage electronic components. If there is a

possibility of ESD damage with a procedure, then do that procedure at an

ESD workstation, or wear an antistatic wrist strap.

When the front cover is open, be sure to close the sample compartment door,

or the sample compartment assembly or the front cover may be damaged.

When transporting the analyzer, the screw at its bottom may scratch your

hands, please exercise caution or wear gloves.


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This equipment must be operated by skilled/trained medical professionals.

Samples, controls, calibrators and waste are potentially infectious. Wear

proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow

safe laboratory procedures when handling them in the laboratory.

All the analyzer components and surfaces are potentially infectious. Take

proper protective measures for operation or maintenance.

The sample probe tip is sharp and may contain biohazardous materials.Exercise caution to avoid contact with the probe when working around it.

Figure 1-1


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Warning, potential biohazardous risk.

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.


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Figure 1-2

Warning, the sample probe is sharp and may contain biohazardous substance. Exercise

caution to avoid contact with the probe when working around it.


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Figure 1-3

Warning, make sure the protective cover is properly installed before operation.

Warning

Do not put your hands close to the sampling assembly when the analyzer is running.

Warning, the sample probe is sharp and may contain biohazardous substance.

Exercise caution to avoid contact with the probe when working around it.

Warning, the sample probe is sharp and may contain biohazardous substance. Exercise


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caution to avoid contact with the probe when working around it.

Figure 1-4

Warning, risk of electric shock.


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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.


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2 Analyzer Structure

2.1 Product Name

Name: Auto Hematology Analyzer.

Models: BC-3600, BC-3300.

2.2 System Introduction

BC-3600 and BC-3300 are in-vitro diagnosis equipments with the functions of blood cell

counting, WBC 3-differential and measurement of HGB concentration under proper working

environment. The purpose of the analyzers is to identify the normal patient, with all normal

system-generated parameters, and to flag or identify patient results that require additional

studies.

Scope: the products can be applied for clinical diagnosing reference and scientific

research.

Environment of use: the analyzers shall be used in medical laboratories with

standardized management; they can not be used as portable equipment.

Operator: the operators must be skilled/trained medical professionals.

2.2.1 System Configuration

The whole system includes the analyzer, accessories and reagents; users can choose to

configure data management software, scanner, printer or PC.

2.2.2 Electrical Parameters

Table2-1 Power supply of the analyzer

Voltage (100V-240V)10%

Input Power 180 VA

Frequency 50/601Hz

Only install fuses of specified specification on the analyzer.

Specification of the fuse: 250V T3.15AH


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2.2.3 Dimension and Weight

Figure 2-1Dimensional sketch map

Table2-2Dimension and weight

Width (mm) Depth (mm) Height (mm) Weight (Kg)

395 450 445 (without foot) 28

2.2.4 ThroughputThe 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 ParametersThe 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%

Width

Height

Depth


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Mid-sized Cell percentage Mid%

Granulocyte percentage Gran%

Red Blood Cell count RBC

Hemoglobin concentration HGB

Mean Corpuscular Volume MCVMean Corpuscular Hemoglobin MCH

Mean Corpuscular Hemoglobin Concentration MCHC

Red Blood Cell Distribution Width Coefficient of

Variation

RDW-CV

Red Blood Cell Distribution Width Standard

Deviation

RDW-SD

Hematocrit HCT

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 Requirement

WBC 0.3 109/ L

RBC 0.031012

/ L

HGB 1 g / L

HCT 0.5 %

PLT 5109/ L


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RBC 08.001012

/L 0.051012

/L or 5 0.051012

/L or 5

HGB 0280g/L 2g/L or 2 2g/L or 3

01000109/L 1010

9/L or 10 1010

9/L or 10PLT

10013000109/L 12 20

HCT 060%4% (HCT value) or 6%

(deviation)

/

Test suggestion:

When testing RBC linearity range 7.008.001012

/L, use sample of which the HCT 60%;

When testing PLT linearity range 10013000109/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 Low concentration

WBC 109

/L > 15.0 < 3.0

RBC 1012

/L > 6.0 < 2.00

HGB g/L > 200 < 40

PLT 109/L > 300 < 100

Table 2-10 Carryover requirements

Parameter Carryover

WBC 0.5

RBC 0.5

HGB 0.5

PLT 1.0

2.2.7 Functions

2.2.7.1 Startup and Shutdown

When starting up the analyzer, initialization will be performed to prepare the analyzer for

counting. Different startup cleaning sequence will be performed base on the latest shutdown

status to ensure the success of background counting. The analyzer provides the function to

skip fluidics initialization to the users of service level and above.


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

2.2.7.2 Password and User Management

In order to protect the security of product setup and data, you have to possess the password to

be able to adjust the parameters and perform the extra functions.

2.2.7.3 Screen Navigation

The analyzer provides screen navigation function so that users can easily go to their target

screen.

2.2.7.4 Status Indication

The analyzer/system status indication function is provided on the analyzer screen or by

configuring LED in the hardware system.

2.2.7.5 Setup

Users can customize the settings of the analyzer on the software screen.

1. The configuration files are saved in the analyzer.2. The analyzer must allow users to modify certain configurations. E.g.: Users can set

up date/time, reference range, parameter unit, communication-related parameters,

print format, etc.

3. For the FDA model, users can set whether to display or print RUO parameters

through the authorization protocol.

4. For the FDA model, users can set "QC lockout", if this function is activated, sample

analysis can be started only after the daily QC passes.

2.2.7.6 Standby

The analyzer will enter standby mode when no fluidic operation has been performed for a

certain period of time. The analyzer will exit the standby mode when operation is triggered

by users.

2.2.7.7 Self Test

The analyzer system provides self test and inspection function to ensure proper running.

2.2.7.8 Sample Review

After analyzing a sample, the analyzer saves the sample information and analysis result

automatically. Operators can review all parameters and histograms of the saved samples.

2.2.8 Sample Compartment

The tube holder in sample compartment can be fitted with adapters of different specifications.

The specifications of supported tubes are:

Evacuated collection tube: diameter: 1013.5mm; height (with cap): 4085mm.

Capillary collection tube: diameter: 1013.5mm; height (with cap): 4065mm.

Centrifugal tubes.


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2.2.9 Operating, Storing and Running Environment

Table 2-11 Temperature and Humidity Requirements

Optimal operating

environment

Storage environmentRunning environment

Temperature 1530 -1040 1535

Humidity 30%85% 10%93% 30%85%

Atmospheric

pressure

70kPa106kPa 50kPa106kPa70kPa106kPa

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 SignalstreamReagentsAirflow


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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

RinseM-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:


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Figure 2-3 Top level menu and QC sub-menu

Figure 2-4 Top level menu and calibration sub-menu


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Figure 2-5 Top level menu and setup sub-menu

Figure 2-6 Top level menu and setup sub-menu(2)


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Figure 2-7 Top level menu and service sub-menu

2.4.2 Password

The login service ID is "Service", password is "s 3600!", case sensitive and space required.

With service access level, you can perform all functions that are open to common users and

some other special functions:

1Transfer factor calibration function:

1Under whole blood mode, click "Menu">"Calibration">"Calibrator", finish the

calibration successfully, exit and save the calibration factors.

2Click "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.


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Figure 2-8Analysis screen of transfer factor under whole blood mode

Table 2-13 Whole blood CV range

Param

eter

WBC RBC HGB MCV PLT

CV

value

2.0% 1.5% 1.5% 0.5% 4.0%

3Click the "Predilute" button to switch to the screen of predilute mode, as Figure 2-9

shows;


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Figure 2-9 Analysis screen of transfer factor under predilute mode

4Click the Diluent icon, perform diluent dispensing for 7 consecutive times;

5Add 140l 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

eter

WBC RBC HGB MCV PLT

CV

value

4.0% 2.0% 2.0% 1.5% 8.0%

2The gain of WBC and RBC can be adjusted, see Figure 2-10;


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Figure 2-10 Gain setup screen

3In 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.


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Analyzer Structure

2-15

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.


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Analyzer Structure

2-16

Figure2-13 Rinse photocoupler calibration menu

Figure2-14 Rinse photocoupler calibration screen


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Analyzer Structure

2-17

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

Connect the connector of the rinse pickup tube to the fitting on the back panel of the

analyzer, click "OK" and then click "Finish", the dialog box "Priming rinse" will pop up,

check the calibration status then: if "Pass" is displayed (see Figure 2-16), that means

the calibration succeeded. The reference voltage and measured voltage are displayed

as "Reference(V)" (1.8-3.0V) and Actual(V) in Figure 2-16.

Figure 2-16

Note:

Rotate the VR1 for 180 degrees more after the D22 turns on, and make sure the LED

is illuminated.

Do not modify the value in the edit box Max(V), Min(V) and Factor(V);

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.

"PASS"

displayed


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Analyzer Structure

2-18

4The reproducibility and carryover functions are available.

Figure 2-17 Menu of reproducibility and carryover

5Check the replacement status of boards and CF card automatically. If the software

system is started and logged in by user of service level, then a prompt will guide the user

to restore the critical data.

Figure 2-18

1) If a new CF card is replaced, follow the guidance to select "Restore" and restore the

critical data to the CF card.

2) If a new data board is replaced, follow the guidance to select "Backup" and backup the

data to the data board.

3) If only the drive board is replaced, no special action shall be taken, the data will not be


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Analyzer Structure

2-19

lost.

6Users 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


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Analyzer Structure

2-20

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.


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3-1

3 Upgrade

3.1 Software upgrade

3.1.1 Preparation

1The whole software upgrade procedure will take about 6~11mins.

2What to do if there is an ERRORduring the upgrade

1If there is a Mounting Failureplease restart the analyzer and run software upgrade again.

2If 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.

3Requirements of the USB flash disk used in this upgrade.

1Please use well-known brand USB flash disk.

2Format(FAT32) the USB flash disk before use it.

3Do NOT remove the USB flash disk during the upgrade.

3.1.2 Upgrade procedure

1Copy the update fileto a formatted USB flash disk.

2Insert the USB flash disk into the USB interface of analyzer (See figure 3-1)

Figure 3-1

3Log in the BC-3600 with Service Engineer username and password.

4Run SetupService SetupSetupStart Upgrade (see figure 3-2), and then click Yes

in the dialog box (see figure 3-3).


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Figure 3-2

Figure 3-3

NOTES:

1Make sure the UBS storage connected well to the USB interface of the Analyzer.

2After 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.

3Do NOT remove the USB flash disk during the upgrade.


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Upgrade

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5software 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)


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Upgrade

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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)


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Upgrade

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Figure 3-10

8) After you finish all the process, please restart the instrument. (See figure 3-11)

Figure 3-11

6After upgrade finished, log in with the service engineer username and password. Run

ServiceVersion to check upgrade items. (See figure 3-12)

Figure 3-12


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Upgrade

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3.1.3 Notes and Prompts of Errors

1During 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

2If upgrade failed, export the debug data. (See figure 3-14)

Figure 3-14


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4-1

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


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4-2

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


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Mechanical System

4-3

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


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4.3 Left of the Analyzer

Figure 4-4 Left of the analyzer (open vial model)

1 --- Top cover 2 --- Front cover assembly

3 --- Side door of electrical system 4 --- Back panel assembly

5 --- Bottom panel assembly


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Mechanical System

4-5

Figure 4-5 Left of the analyzer (closed tube model)


3 --- Side door of electrical system 4 --- Back panel assembly



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4.4 Right of the Analyzer

Figure 4-6 Right of the analyzer (open vial model)


3 --- Side door of fluidic system 4 --- Door lock

5 --- Aspirate key 6 --- Back panel assembly



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4-7

Figure 4-7 Right of the analyzer (closed tube model)


3 --- Side door of fluidic system 4 --- Door lock

5 --- Aspirate key 6 --- Back panel assembly



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5-1

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 100l; 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.


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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

one analysis cycle of a

sampleItem Name

Whole blood Predilute

Diluent M-30D DILUENT 28mL 28mL

LyseM-30CFL LYSE

0.35mL 0.35mL

Rinse M-30R RINSE 8mL 8mL

Probe

cleanserPROBE CLEANSER

0 0

Control B30BC-3D /

Calibrator S30SC-CAL PLUS /


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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 forRBC/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


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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:


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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: 300l

Function description: Mix 9ul of blood and 2.35ml of diluent in the WBC bath,

provide 34ul of first dilution sample to the RBC bath and add 0.35ml of lyse into it,

mix them; then aspirate the mixed sample into the back bath through the aperture by

the vacuum of the vacuum chamber. The cells are analyzed when they pass the

aperture. Volume of the sample analyzed is measured by the volumetric tube.


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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: 200l

Function description: the sample probe aspirates 34ul of sample (dilution ratio:

1:262.11) from the WBC bath, add 0.8ml of mixture of the sample and diluent into the

RBC bath to form the sample of dilution ratio 1:20000 with another 1.8ml of diluent;

Mix them and aspirate the sample by vacuum of the vacuum chamber into the back

bath through the aperture. The cells are analyzed when they pass the aperture.

Volume of the sample analyzed is measured by the volumetric tube.

5.5 Introduction of Basic Sequence

5.1.1 Whole Blood Analysis Sequence

This section introduces the working procedure of sample probe in the measurement sequence

first, then all the other working procedures are introduced in detail.

5.5.1.1 Sampling and dispensing procedure

The working procedure of sample probe is indicated in Figure 5- 3. See section 5.3 for the

sample dilution procedure. The working procedure of sample probe:

a) Sample aspirating

piercing(closed tube models)

aspirating 17ul of sample.

b) First dilution

When aspiration finishes, the sample probe ascends;

The sample probe moves to the top of the WBC bath; The sample probe descends to the WBC bath and dispenses 9ul of sample.

c) Aspirating sample from the WBC bath

The sample probe ascends from the WBC bath, and removes the residual

sample in the probe wipe;

The sample probe descends to the WBC bath and aspirates 34ul of first dilution

sample.

d) Second dilution in the RBC bath

When aspiration finishes, the sample probe ascends from the WBC bath;

The sample probe moves to the top of the RBC bath;

The sample probe descends to the RBC bath, and dispenses 0.8ml of mixture of

the sample and diluent.


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Fluidic System

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Initialize position of the sample probe by command INIT.

RBC WBC

?

?

?

RBC WBC

? ?

RBC WBC

?

a) b)

c) d)

?

?

Secon

d

dilutionsam le

First

dilutio

n

sampl

DiluentBlood

sample

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.


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Fluidic System

5-8

Diluent

Waste

V01

V04V02

100ul

10ml

V19

Diluent

Waste

V01

V04V02

V19

b) Wash interior wall of

sample probe

a) Wash exterior wall of

sample probe

100ul

10ml

Figure 5- 4 Fluidic passages of sample probe cleaning

The sample probe descends to the sampling position, and then moves to the

piercing position, the syringe withdraws for 2ul to create separating bubbles.

Then the sample probe descends to the lowest aspirating position to prepare for

sample aspirating. Besides, the fluidic passages of draining and dispensing of

the WBC bath are indicated in Figure 5- 5 and Figure 5- 6; Under the effect of

vacuum, rinse flows through and washes the WBC and RBC back baths and

their volumetric tubes, the fluidic passage of washing the WBC back bath and

volumetric tube is indicated in Figure 5- 7; When the washing progress ends,

Valve 5 and 6 opens to drain the volumetric tubes.


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Fluidic System

5-9

Diluent

Waste

V01

Isolationchamber

WBC

bath

V16

V03

Lyse

V04

V02

10mL

SR3

2.5mL

(SR1)

Figure 5- 5 Fluidic passage of draining of the WBC bath

DiluentV01

WBC

bath

V03

lyse

V04

V02

10mL

SR32.5mL

(SR1)

Figure 5- 6 Fluidic passage of dispensing of the WBC bath


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Fluidic System

5-10

Rinse

Waste

V09Isolation

chamber

WBC

bath

V10

V16

V14

Volumetricboard

V05 V07

V18

Vacuum

chamber

Pressure

Atmosp

heric

pressure

Figure 5- 7Fluidic passages of washing WBC back bath and volumetric tube

Aspirating sample: the sampling syringe aspirates 17ul of sample at 6.5~8.5s;

and 800ul of diluent is added to the RBC bath after it is drained;

Ascending to home position: the sample probe ascends to home position at

9.3~11.6s, and its exterior wall is washed; by now, the sampling procedure isfinished.

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 isdispensed into the RBC bath.


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Second aspiration in the WBC bath: the sample probe descends to the WBC

bath and aspirates 34 ul of fluid at 19.9~21s.Valve 17 opens, and the RBC bath

is drained.

The sample probe ascends: when the second aspiration finishes, the sample

probe ascends to home position with its exterior wall washed; besides, 1800 ul

of diluent is added to the RBC bath at 24.5~25.5s.

Adding sample to RBC bath, and lyse to WBC bath: the sample probe moves to

the RBC bath and descends into the bath; the lyse syringe dispenses 350ul of

lyse into the WBC bath, the fluidic passage is indicated in Figure 5- 8; the diluent

syringe discharges 800 ul of fluid (mixture of first dilution sample and diluent)

through the sample probe. Valve 10 opens at 26.65~27.25s, the pressure

chamber blows bubbles into the WBC bath; then a bubble that can last for 0.05s

is blowed into the WBC bath, and 3 bubbles are blowed into the RBC bath in

turn; Finally, the sample probe restores to the original position with its exterior

wall washed.

WBC

bath

V03

Lyse

2.5mL

(SR1)

Figure 5- 8 Fluidic passage of lyse dispensing of the WBC bath

Other actions finished during the sample dispensing, dilution and mixing

procedure:

Build the vacuum needed for analysis, total time consumed is 7.9s;

Build the pressure needed for bubble generation;

RBC aperture voltage inspection: same as WBC aperture voltage inspection;

The sample compartment door opens at 12s to prepare for the next analysis

cycle.

Analysis

The actions are:

Measuring volume of volumetric tube: valve 7 opens after WBC bubbling

finishes for a while and valve 8 opens after RBC bubbling finishes for a while,

the fluidic passage is indicated in Figure 5- 9; the closing of valve 7 and valve 8

is finished by the ending cleaning cycle started when the WBC and RBC downphotocouplers are triggered.


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5-12

RBC

bath

Volumetric

board

Rinse

Waste

V06 V08

V15

WBC

bath

V14

Volumetric

board

V05 V07

V18

Vacuum

chamber

Figure 5- 9 Fluidic passages of WBC and RBC analysis

The photocoupler of volumetric board is opened at 25.7s.

Cleaning when analysis ends

The actions are:

The ending cleaning sequence is an independent sequence, it is started by the

software automatically base on the information obtained during the analysis;

Fluid discharging of RBC and WBC baths: open valve 17, the RBC bath starts to

discharge fluid; open valve 16, the WBC bath starts to discharge fluid;

Fluid dispensing of RBC and WBC baths: 1400 ul of fluid is dispensed into the

RBC and WBC bath respectively;

Washing RBC and WBC back baths: when valve 8 and valve 15 open at the

same time, the RBC back bath will be washed by rinse under the effect ofvacuum; when valve 7 and valve 14 open at the same time, the WBC back bath

will be washed by rinse under the effect of vacuum.

Draining the vacuum chamber: open valve 9 to drain the vacuum chamber.

Resetting of the diluent syringe and sample probe assembly: the diluent syringe

aspirates 2100 ul of fluid, then valve 1 opens, the syringe returns to home

position and dispenses fluid to the RBC bath at the same time; the sample probe

assembly returns to home position.

The sample probe aspirates air bar and returns to home position: the sample

probe moves to the piercing position and withdraws for 2ul and then returns to

home position.

Zapping: zapping starts when fluid dispensing of WBC bath completes for a

while.

Calculating the volume of rinse consumed: the software reads from the

command to calculate the volume of rinse consumed.

Detecting rinse status: sensor in the analyzer detects if the rinse container is

empty; when alarming for no rinse, the residual volume of rinse must be able to

support the on-going analysis.

The major difference between the whole blood analysis sequences of open vial models and

closed tube models lies in the sampling procedure, the open vial sequence involves nopiercing action, but its sampling time point and the cleaning action after sampling are the same


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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:


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5-14

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


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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,


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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


startup sequence after normal shutdown.



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


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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 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 theclosed 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


overall reagent priming sequence.



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.


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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:


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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 highconcentration compound (38.46%) for the first soak.


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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 aspiratedis 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:


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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.


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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:


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Figure 5-15 Soaking procedure

Introduction: the intensified probe cleanser soak procedure is almost the same as the generalprobe cleanser soak procedure, the only difference lies in the dilution ratio of probe cleanser.


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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.


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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.


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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 DiagramSee Figure 6-1 for the function diagram of the hardware system.

Figure 6-1Function diagram of the hardware system

The hardware system consists of f ive 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, monitoringphotocouplers and other major parameters, collecting detection information and


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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.


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Figure 6-2 Electric connection diagram of the hardware system


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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


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(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 digitalpart 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


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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 "CPUFPGA", see Figure 6-7.The functions of the

BC-3600&3300 Service Manual V1.0

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Transcript of BC-3600&3300 Service Manual V1.0