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BC-3600 BC-3300

Auto Hematology Analyzer

Service Manual

Copyright © 2008-2015 Shenzhen Mindray Bio-medical Electronics Co., Ltd.

All rights Reserved.

For this Service Manual, the issued Date is 2015-06 (Version: 2.0).

Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rent, adaptation and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

.

,

are the registered trademarks or trademarks owned by

Mindray in China and other countries.

All other trademarks that appear in this manual are

used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for safety, reliability and performance of this product only in the condition that: 

all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;



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

I

and local requirements; 





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

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

It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or injury of human health.



Be sure to operate the analyzer under the situation specified in this manual; otherwise, the analyzer will not work normally and the analysis results will be unreliable, which would damage the analyzer components and cause personal injury.

II

Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to: 

any Mindray product which has been subjected to misuse, negligence or accident;



any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed;



any product of any other manufacturer.

Safety, Reliability and Performance Mindray is not responsible for the effects on safety, reliability and performance of BC-2800Vet, if: 

Assembly operations, extensions, re-adjusts, modifications or repairs are carried out by persons other than those authorized by Mindray.



Personnel unauthorized by Mindray repairs or modifies the instrument.

Return Policy Return Procedure In the event that it becomes necessary to return this product or part of this product to Mindray, the following procedure should be followed:

1.

Obtain return authorization: Contact the Mindray Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Returned shipments will not be accepted if the Mindray number is not clearly visible. Please provide the model number, serial

III

number, and a brief description of the reason for return; 2.

Freight policy: The customer is responsible for freight charges when this product is shipped to Mindray for service (this includes customs charges);

3.

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

Company Contact Manufacturer: Address:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, ShenZhen 518057, P.R.China,

Phone:

+86 755 81888998

Fax:

+86 755 26582680

EC-Representative:

Shanghai International Holding Corp. GmbH(Europe)

Address:

Eiffestraβe 80, 20537 Hamburg Germany

Phone:

0049-40-2513175

Fax:

0049-40-255726

IV

Table of Contents Copyright ···I Intellectual Property Statement ···········································································I Responsibility on the Manufacturer Party ······························································I Warranty······································································································III Exemptions ··································································································III Return Policy ································································································III 1

2

3

Using This Manual 1.1.

Scope ····························································································1-2

1.2.

Introduction ····················································································1-2

1.3.

Conventions Used in This Manual ························································1-3

1.4.

Special Terms Used in This Manual ······················································1-3

1.5.

Symbols ·························································································1-4

1.6.

Definitions ····················································································1-12

Analyzer Structure

5

6

2-1

2.1

Product Name ······················································································2-1

2.2

System Introduction ··············································································2-1

2.3

System Composition ·············································································2-7

2.4

Software Structure ················································································2-8

2.5

LIS Connection ··················································································2-19

Upgrade 3.1

4

1-1

3-1

Software upgrade ·················································································3-1

Mechanical System

4-1

4.1

Front of the Analyzer ·············································································4-1

4.2

Back of the Analyzer ··············································································4-3

4.3

Left of the Analyzer ···············································································4-4

4.4

Right of the Analyzer ·············································································4-6

Fluidic System

51

5.1

Fluidic Components and Functions ···························································5-1

5.2

Reagent Consumption ···········································································5-2

5.3

Sample Dilution Flowchart ······································································5-3

5.4

Introduction of Fluidic Channels ·······························································5-5

5.5

Introduction of Basic Sequence································································5-6

Hardware System 6.1

6-1

Introduction ·························································································6-1 1

Table of Contents

7

8

6.2

Data Board ··························································································6-5

6.3

Drive Board ·······················································································6-18

6.4

Power Board ·····················································································6-25

6.5

USB Interface Board ···········································································6-30

6.6

Touchscreen Control Board ···································································6-31

6.7

Volumetric Board ················································································6-32

6.8

Sample Compartment Connection Board ·················································6-34

6.9

Indicator Board···················································································6-35

Servicing

7-1

7.1

General ······························································································7-1

7.2

Disassembling the Panels ······································································7-2

7.3

Replacing the Hardware parts and Cable connection ····································7-6

7.4

Replacing the Power Supply Assembly ····················································7-16

7.5

Replacing the Display Assembly ····························································7-17

7.6

Replacing the Touch Screen··································································7-18

7.7

Replacing the Recorder Assembly ··························································7-19

7.8

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

7.9

Replacing the counting bath assembly ····················································7-29

7.10

Replacing the syringe assembly ························································7-35

7.11

Replacing the sample probe assembly················································7-37

7.12

Replacing the sample compartment assembly ······································7-47

7.13

Replacing the start key ····································································7-56

7.14

Micro-Switch Assembly Replacement ·················································7-57

7.15

Fluidic Support-bracket Assembly ······················································7-58

7.16

Front Panel Detection Assembly ························································7-59

7.17

Ambient Temperature Sensor Replacement ·········································7-60

7.18

Cap Assembly ···············································································7-61

7.19

Gain Adjustment ············································································7-62

7.20

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

7.21

The Check List After Material Replacement ·········································7-64

Maintaining your analyzer

8-1

8.1 General Guidelines ··················································································8-1 8.2 Operation guidance of Quality Control and Calibration ·····································8-2 9

10

Error Information

9-1

9.1

Error Information and Code ·····································································9-1

9.2

Error analysis and processing ·································································9-2

9.3

Error diagnosis assisted by abnormal histogram ········································9-12

9.4

Error diagnosis assisted by abnormal pulse figure ·····································9-21 Appendices

A-1

2

1

Using This Manual

This chapter explains how to use this service manual. This manual states in detail the way to service the BC-3600 and BC-3300 analyzers. Before servicing the BC-3600 and BC-3300, read and understand the manual carefully for servicing the equipment properly and for your safety. This manual is to be used in conjunction with the operator's manuals of BC-3600 and BC-3300.It does not contain information and procedures already covered in the operator's manuals of BC-3600 and BC-3300.



Be sure to operate and service the analyzer strictly as instructed in this manual and the operator's manuals.

1-1

Using This Manual

1.1. Scope To use this manual effectively, you need the following capabilities: 

Comprehensive knowledge of circuit and fluidics;



Comprehensive knowledge of reagents;



Comprehensive knowledge of controls;



Comprehensive knowledge of troubleshooting;



Mastering the way to operate this analyzer;



Using basic mechanical tools and understand related terminology;



Using a digital voltmeter (DVM) and an oscilloscope;



Reading pneumatic/hydraulic schematics and understand related terminology.

1.2. Introduction This manual comprises 9 chapters and 6 appendices. Refer to the table below to find the information you need. If you want to …

See …

learn about the system and software structures of BC-3600

Chapter 2 System Structure

and BC-3300 learn about the installation requirements and the way to

Chapter 3 System Installation

upgrade the software of BC-3600 and BC-3300

and Software Upgrade

learn about the mechanical system structure of BC-3600 and

Chapter 4 Mechanical System

BC-3300 learn about the fluidic system, reagent dosage, channels and

Chapter 5 Fluidic System

basic sequence of BC-3600 and BC-3300 learn about the hardware system and board composition,

Chapter 6 Hardware System

adjustment and test points and general troubleshooting methods of BC-3600 and BC-3300 learn about how to service the BC-3600 and BC-3300

Chapter 7 Servicing

learn about how to maintain the BC-3600 and BC-3300

Chapter 8 Maintenance

learn about how to troubleshoot the common errors of

Chapter 9 Troubleshooting

BC-3600 and BC-3300 learn about the main spare parts of BC-3600 and BC-3300

Appendix A List of Spare parts

learn about the main wearing parts of BC-3600 and

Appendix B List of Wearing

BC-3300

Parts

learn about the circuit diagram of BC-3600 and BC-3300

Appendix C Circuit Diagram

learn about the schematic diagram of the fluidic system of

Appendix D Fluidic Diagram

1-2

Using This Manual BC-3600 and BC-3300 learn about the function of each valve and pump of BC-3600

Appendix E Pump and Valve

and BC-3300

Function Diagram

learn about the tubing connection of BC-3600 and BC-3300

Appendix F Tubing

1.3. Conventions Used in This Manual This manual uses certain typographical conventions to clarify meaning in the text: Format

Meaning ××all capital letters enclosed in [ ] indicate a key name (either on

[××]

the pop-up keyboard or the external keyboard) ××letters included in " " indicate text you can find on the screen

“××”

of BC-3600 and BC-3300 ××为 italic letters indicate titles of the chapters that are referred

××

to

"Menu" the "

" button on the screen.

All illustrations in this manual are provided as examples only. They may not necessarily reflect your analyzer setup or data displayed.

1.4. Special Terms Used in This Manual When you read …

It means … to press the desired item lightly with your finger; or to

Click

left-CLICK it with the mouse. to CLICK the desired edit box and use the external keyboard or the pop-up keyboard to enter the desired characters or

ENTER

digits; or to scan the number by using the bar-code scanner. to move the cursor to the character or digit that you want to delete by clicking the left button of the mouse or using [←][→][Home][End], and then delete the character after the

DELETE

cursor by pressing [Del], or delete the character before the cursor by pressing [BackSpace] ([←] on the upper right part of the soft keyboard).

SELECT from

××

pull-down list (for pull-down list)

to CLICK the down arrow button of the desired box to display the pull-down list, (and DRAG SCROLL BAR) to browse and then CLICK the desired item; or to press the keys ([↑][↓][PageUp][PageDown]) to browse the current list and

1-3

Using This Manual press [ENTER] to select the desired item.

1.5. Symbols You will find the following symbols in this manual. When you see…

Then… read the statement below the symbol. The statement is alerting you to an operating hazard that can cause personnel injury. read the statement below the symbol. The statement is alerting you to a possibility of analyzer damage or unreliable analysis results. read the statement below the symbol. The statement is alerting you to information that requires your attention. read the statement below the symbol. The statement is alerting you to a potentially biohazardous condition.

You may find the following symbols on the analyzer, reagents, controls or calibrators. When you see…

It means… CAUTION, CONSULT ACCOMPANYING DOCUMENTS. BIOLOGICAL RISK

HIGH VOLTAGE

EXERCISE CAUTION WHEN WORKING AROUND TO AVIOD PRICKING PROTECTIVE EARTH (GROUND)

ALTERNATING CURRENT

1-4

Using This Manual FOR IN VITRO DIAGNOSTIC USE

BATCH CODE

USE BY (YYYY-MM-DD)

SERIAL NUMBER

MEASUREMENT AUTHORIZATION SYMBOL DATE OF MANUFACTURE

MANUFACTURER

THIS ELECTRO-INFORMATIONAL PRODUCT CONTAINS CERTAIN POISONOUS OR HARMFUL SUBSTANCE. ITS ENVIRONMENTAL LIFT TIME IS 20 YEARS. IT CAN BE USED WHTHIN 20 YEARS, AFTER THAT IT SHALL BE RECYCLED. Be sure to observe the following precautions for the safety of patients and operators when you are servicing the analyzer.



It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or harm to human health.



Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g. ethanol) around the analyzer. Otherwise, the risk of explosion may exist.



When servicing the analyzer, be sure to turn off the power. Servicing the analyzer when it is on may bring risk of electric shock or damage to electronic components.



Connect the analyzer to a socket having sole fuse and protective switch. Do

1-5

Using This Manual not use the same fuse and protective switch with other equipment (e.g. life supporting equipment). Otherwise, the equipment failure, over current or impulse current that occurs at the startup moment may lead to tripping. 

To prevent personal injury during maintenance, keep your clothes, hairs and hands from the moving parts, such as sample probe, clipper and piercer.



Possible mechanical movement of the warned position may lead to personal injury during the normal operation, removal and maintenance.



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



The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.



If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.



Improper maintenance may damage the analyzer. Maintain the analyzer strictly as instructed by the service manual and inspect the analyzer carefully after the maintenance.



For problems not mentioned in the service manual, contact Mindray customer service department for maintenance advice.



To prevent personal injury or damage to equipment components, remove metal jewelry before maintaining or servicing electronic components of the equipment.



Electrostatic discharge may damage electronic components. If there is a possibility of ESD damage with a procedure, then do that procedure at an ESD workstation, or wear an antistatic wrist strap.



When the front cover is open, be sure to close the sample compartment door, or the sample compartment assembly or the front cover may be damaged.



When transporting the analyzer, the screw at its bottom may scratch your hands, please exercise caution or wear gloves.

1-6

Using This Manual



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



Samples, controls, calibrators and waste are potentially infectious. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.



All the analyzer components and surfaces are potentially infectious. Take proper protective measures for operation or maintenance.



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

Figure 1-1

1-7

Using This Manual

① Warning, potential biohazardous risk.

② 

Make sure the analyzer is properly grounded.



To avoid electric shock, disconnect power cord prior to removing or replacing fuse.



Use fuse only with the type and rating specified.

1-8

Using This Manual

Figure 1-2

① Warning, the sample probe is sharp and may contain biohazardous substance. Exercise caution to avoid contact with the probe when working around it.

1-9

Using This Manual

Figure 1-3

① Warning, make sure the protective cover is properly installed before operation.

② Warning 

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



Warning, the sample probe is sharp and may contain biohazardous substance. Exercise caution to avoid contact with the probe when working around it.

③ Warning, the sample probe is sharp and may contain biohazardous substance. Exercise

1-10

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

Figure 1-4

① Warning, risk of electric shock.

1-11

Using This Manual

1.6. Definitions There are two sampling mode: open vial mode and closed tube mode. 

Open vial mode

The operator presents the tube or open vial evacuated collection tube containing blood sample to the sample probe, and press the "Aspirate" key to collect sample. The analyzer of which the sampling mode is open vial is called open vial analyzer. 

Closed tube mode

The operator puts the capped tube into the sample compartment, the analyzer collects sample by piercing through the tube cap. The analyzer of which the sampling mode is closed tube is called closed tube analyzer.

1-12

2

Analyzer Structure

2.1 Product Name Name: Auto Hematology Analyzer. Models: BC-3600, BC-3300.

2.2 System Introduction BC-3600 and BC-3300 are in-vitro diagnosis equipments with the functions of blood cell counting, WBC 3-differential and measurement of HGB concentration under proper working environment. The purpose of the analyzers is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies. 

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



Environment of use: the analyzers shall be used in medical laboratories with standardized management; they can not be used as portable equipment.



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

2.2.1 System Configuration The whole system includes the analyzer, accessories and reagents; users can choose to configure data management software, scanner, printer or PC.

2.2.2 Electrical Parameters Table2-1 Power supply of the analyzer Voltage

(100V-240V～)±10%

Input Power

≤180 VA

Frequency

50/60±1Hz



Only install fuses of specified specification on the analyzer.

Specification of the fuse: 250V

T3.15AH 2-1

Analyzer Structure

2.2.3 Dimension and Weight

Height Depth Width Figure 2-1Dimensional sketch map Table2-2Dimension and weight Width (mm)

Depth (mm)

Height (mm)

≤395

≤450

≤445 (without foot)

Weight (Kg) ≤28

2.2.4 Throughput The throughput of open vial analyzers under whole blood mode is no less than 60 samples per hour; the time needed for the analysis of one sample is no more than 60s (the sample dilution time is not included for predilute mode). The throughput of closed tube analyzers under whole blood mode is no less than 60 samples per hour; the time needed for the analysis of one sample is no more than 60s (the sample dilution time is not included for predilute mode).

2.2.5 Parameters The analyzer determines 21 parameters (WBC, RBC, PLT, HGB, etc.) and 3 histograms (WBC, RBC and PLT) of blood samples. Table 2-3Table of parameters English name

Abbreviation

White Blood Cell count

WBC

Lymphocyte number

Lymph#

Mid-sized Cell number

Mid#

Granulocyte number

Gran#

Lymphocyte percentage

Lymph%

2-2

Analyzer Structure Mid-sized Cell percentage

Mid%

Granulocyte percentage

Gran%

Red Blood Cell count

RBC

Hemoglobin concentration

HGB

Mean Corpuscular Volume

MCV

Mean Corpuscular Hemoglobin

MCH

Mean Corpuscular Hemoglobin Concentration

MCHC

Red Blood Cell Distribution Width Coefficient of

RDW-CV

Variation Red Blood Cell Distribution Width Standard

RDW-SD

Deviation Hematocrit

HCT

Platelet count

PLT

Mean Platelet Volume

MPV

Platelet Distribution Width

PDW

Plateletcrit

PCT

Platelet Larger Cell Ratio

P-LCR

Platelet Larger Cell Count

P-LCC

Table2-4Table of histograms White Blood Cell Histogram

WBC Histogram

Red Blood Cell Histogram

RBC Histogram

Platelet Cell Histogram

PLT Histogram

2.2.6 Performance Specifications 2.2.6.1 Background or Blank Counting Background counting is performed by the analyzer automatically when it is started up. The following requirements must be met. Blanking counting: test the diluent for 3 consecutive times, and take the highest result. The following requirements must be met. Table 2-5 Requirements on background or blank counting Parameter WBC

Requirement 9 ≤ 0.3  10 / L

RBC

≤ 0.03 10 / L

HGB

≤1g/L

HCT

≤ 0.5 %

PLT

≤ 5 10 / L

12

9

2-3

Analyzer Structure

2.2.6.2 Reproducibility Run the sample meeting the reproducibility requirements for 10 consecutive times on the analyzer, then calculate the CV(%) and SD, the requirements in Table 2-6 and 2-7 must be met.

Table 2-6 Whole blood reproducibility requirements Condition

Parameter

CV%/SD ≤ 2.5

7.0 ~ 15.0  10 / L 9

WBC

4.0 ~ 6.9  10 / L

RBC

3.50 ~ 6.50  10

HGB

100 ~ 180 g/L

≤ 1.5

MCV

70.0~ 110.0 fL

≤ 0.5

9

≤ 3.5

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

RBC

3.50 ~ 6.50 10

12

≤ 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

100.1～200×10 /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

0～67%

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≤ 67%; 9

② When testing PLT linearity range 1001～3000×10 /L, use sample of which the RBC≤ 6.

2.2.6.4 Carryover The carryover impact of high concentration sample to low concentration sample. Test method: mix the high value sample (centrifuged high value control or specialized high value linearity control) within the range of

Table 2-9, test the sample for 3 consecutive times,

and then mix and test the low value sample (diluted low value control, dilution rate 1:10) within the range of Table 2-9 for 3 consecutive times, then calculate the carryover. The requirements in Table 2-10 must be met. Table 2-9 Requirements on high and low value controls of carryover calculation Parameter

Unit

High concentration

9

WBC

×10 /L

Low concentration

> 15.0

< 3.0

RBC

12

×10 /L

> 6.0

< 2.00

HGB

g/L

> 200

< 40

9

> 300

< 100

PLT

×10 /L

Table 2-10 Carryover requirements Parameter

Carryover

WBC

≤0.5％

RBC

≤0.5％

HGB

≤0.5％

PLT

≤1.0％

2.2.7 Functions 2.2.7.1 Startup and Shutdown When starting up the analyzer, initialization will be performed to prepare the analyzer for counting. Different startup cleaning sequence will be performed base on the latest shutdown status to ensure the success of background counting. The analyzer provides the function to skip fluidics initialization to the users of service level and above.

2-5

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

2.2.7.2 Password and User Management In order to protect the security of product setup and data, you have to possess the password to be able to adjust the parameters and perform the extra functions.

2.2.7.3 Screen Navigation The analyzer provides screen navigation function so that users can easily go to their target screen.

2.2.7.4 Status Indication The analyzer/system status indication function is provided on the analyzer screen or by configuring LED in the hardware system.

2.2.7.5 Setup Users can customize the settings of the analyzer on the software screen. 1.

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: 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. Reagent s

Quantify reagents

S a m pl e

Pierce

WBC inspectio n

WBC reaction

Open vial

RBC dilution

sampling/ distributio n

HGB reaction

RBC inspectio n

Signal proces sing

HGB inspectio n

Sample detection

Data man agement

Schedule control and information processing

Sample preparation

Clean

Para. analy sis

Waste collection

Power

Status monitor

Clean and maintenance Fluid

Human machine interface

Air flow

2-7

Reagents

Signal stream

Analyzer Structure Figure 2-2 System function block diagram

2.3.2 Reagents In order to ensure the accuracy of analysis results, you shall use the reagents, controls and calibrators specified by Shenzhen Mindray Bio-medical Electronics Co., Ltd. For details, refer to Table 2-12. Table 2-12 Applicable reagents, controls calibrators Item

Name

Diluent

M-30D DILUENT

Lyse

M-30CFL LYSE

Rinse

M-30R RINSE

Probe cleanser

PROBE CLEANSER

Control

B30 or BC-3D

Calibrator

S30 or SC-CAL PLUS

2.4 Software Structure 2.4.1 Menu Structure The top level structure of the system menu includes 8 functional options: analysis, review, QC, calibration, setup, service, logoff and shutdown. Operators can enter the screens to perform the functions of the analyzer through the system menu. The " " indicates there is sub-menu under the option. Refer to Figure 2-3 -- Figure 2-7 for the full menu structure. The menu structure of service access level:

2-8

Analyzer Structure

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

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

2-9

Analyzer Structure

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

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

2-10

Analyzer Structure

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

2.4.2 Password The login service ID is "Service", password is "s 3600!", case sensitive and space required. With service access level, you can perform all functions that are open to common users and some other special functions: 1、 Transfer factor calibration function: 1） Under whole blood mode, click "Menu"—>"Calibration"—>"Calibrator", finish the calibration successfully, exit and save the calibration factors. 2） Click "Menu"—>"Calibration"—>"Transfer factor" to enter the screen in Figure 2-8, run the sample used in the above step for 5 consecutive times under whole blood mode, check if CV(%) meets the requirements in Table 2-13; if not, cancel a abnormal result and calculate again (results of at least 5 analyses required), then check if the requirements in Table 2-13 are met.

2-11

Analyzer Structure

Figure 2-8Analysis screen of transfer factor under whole blood mode Table 2-13 Whole blood CV range Param

WBC

RBC

HGB

MCV

PLT

≤2.0%

≤1.5%

≤1.5%

≤0.5%

≤4.0%

eter CV value 3） Click the "Predilute" button to switch to the screen of predilute mode, as Figure 2-9 shows;

2-12

Analyzer Structure

Figure 2-9 Analysis screen of transfer factor under predilute mode 4） Click the Diluent icon, perform diluent dispensing for 7 consecutive times; 5） Add 140μl of calibrator in to the diluent, mix thoroughly and then run the mixture for more than 5 times under the predilute mode. The CV(%) values must meet the requirements of Table 2-14, and the calibration factors are within the range [0.75, 1.25]. Table 2-14 Range of CV value under predilute mode Param

WBC

RBC

HGB

MCV

PLT

≤4.0%

≤2.0%

≤2.0%

≤1.5%

≤8.0%

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

2-13

Analyzer Structure

Figure 2-10 Gain setup screen 3、 In the service setup screen, you can set up languages, software upgrade, volume of the volumetric tube, analyzer SN, sample probe positioning adjustment, background information monitoring (auto adjust of analysis time), rinse photocoupler calibration, etc. The following section will introduce the sample probe positioning adjustment and rinse photocoupler calibration functions. 1) Sample probe positioning adjustment: Tool: the positioning calibration clamp of sample probe sampling position Procedure: open the cover as Figure 2-11 shows, open the sample compartment door, take out the tube holder adapter from the compartment, put the positioning calibration clamp to the sample compartment, and then close the compartment door.

2-14

Analyzer Structure

Figure 2-11 Sample compartment Click the "Aspirate pos." under the "X direction motor" as shown in Figure 2-12, and click "Start", then click the "Move Left" or "Move Right" button to move the sample probe to the top of the positioning hole of the fixture, check if the tip of the probe is right against the positioning hole, then click "Save" to save the setting.

Figure 2-12 Sample probe positioning adjustment Note: the tip of the probe must be right against the positioning hole (judge by visual inspection). 2) Rinse photocoupler calibration Tool: 101 slot-headed screwdriver Procedure:

as

Figure

2-13

shows,

click

"Menu""Setup""Service

Setup""Photocoupler Cal.", the dialog box shown in Figure 2-14 will pop up.

2-15

Analyzer Structure

Figure2-13 Rinse photocoupler calibration menu

Figure2-14 Rinse photocoupler calibration screen

2-16

Analyzer Structure ① Click "Start" and then click "OK", the dialog box "Priming diluent" will pop up, then an instruction message will be displayed, use the slot-headed screwdriver to rotate the potentiometer VR1(RINSE) on the drive board (see Figure 2-15) counter-clockwise until the D22 (RINSE-LED) turns on. Note: continue to rotate the VR1 for 180 degrees after the D22 turns on.

Figure 2-15 ② Connect the connector of the rinse pickup tube to the fitting on the back panel of the analyzer, click "OK" and then click "Finish", the dialog box "Priming rinse" will pop up, check the calibration status then: if "Pass" is displayed (see Figure 2-16), that means the calibration succeeded. The reference voltage and measured voltage are displayed as "Reference(V)" (1.8-3.0V) and Actual(V) in Figure 2-16.

"PASS" displayed

Figure 2-16 Note: ① Rotate the VR1 for 180 degrees more after the D22 turns on, and make sure the LED is illuminated. ② Do not modify the value in the edit box Max(V), Min(V) and Factor(V); ③ If calibration cannot be done successfully due to the quality of the photocoupler itself and the PCBA or photocoupler must be replaced, then recalibration is needed. The dialog box "Remove the Rinse tube from the container and press [OK] to continue." will pop up, press [OK] to drain the tubing; then do as instructed by the prompt - "1. Adjust rinse photocoupler potentiometer till the RINSE-LED turns on; 2 Put the Rinse tube into the container and press [OK]to close the dialog box; 3. Click [Finish] button" to prime rinse after calibration is done.

2-17

Analyzer Structure

4、 The reproducibility and carryover functions are available.

Figure 2-17 Menu of reproducibility and

carryover

5、 Check the replacement status of boards and CF card automatically. If the software system is started and logged in by user of service level, then a prompt will guide the user to restore the critical data.

Figure 2-18 1) If a new CF card is replaced, follow the guidance to select "Restore" and restore the critical data to the CF card. 2) If a new data board is replaced, follow the guidance to select "Backup" and backup the data to the data board. 3) If only the drive board is replaced, no special action shall be taken, the data will not be

2-18

Analyzer Structure lost. 6、 Users of the service level can export special information, see the figure below.

Figure 2-19

2.5 LIS Connection 2.5.1 LIS Setup and Adjustment 1. Click "Menu""Setup""System Setup""Communication", the following screen will be displayed.

Figure 2-20 Communication setup screen

2-19

Analyzer Structure 2. Select network communication or serial port communication base on the physical medium used. 3. If serial port communication is selected, communication can be realized when the parameter settings of the serial port are identical with those of the LIS software. The handshake function shall also be set up base on the LIS software used. 4. If network communication is selected, it is recommended that direct-coupled network wire is used, and the major IP addresses such as 192.168.0. or 10.0.0.* are set up. When connected to LAN, set up the IP address per the IP rules of the LAN. ACK synchronous transmission shall also be set up base on the LIS software settings. If you are not sure about that, use the default setup.

2.5.2 Connection Testing It is recommended that you use Mindray data management software to perform actual communication testing, or you can use the testing software developed by a compatible software developer.

2.5.3 Analysis of Communication Failure 1. For abnormal serial port connection, check parameter settings. If the settings are identical to those of the analyzer, replace serial port wire. 2. For abnormal network connection, check parameter settings. If the settings are correct, check if the connection is normal by using ping. (If network firewall is installed in the computer of the LIS end, turn off the firewall). If the ping command fails to restore the connection, check if the network wire is well connected. If physical connection is good, and the communication parameters and protocol settings are correct, but communication failure persists, check if the LIS software complies with the communication protocol. Refer to the operator's manual for the communication protocols.

2-20

3

Upgrade

3.1 Software upgrade 3.1.1 Preparation 1、The whole software upgrade procedure will take about 6~11mins. 2、What to do if there is an ERROR during the upgrade 1）If there is a Mounting Failure，please restart the analyzer and run software upgrade again. 2） If there is a Upgrade Failure, please check the upgrade package in your USB flash disk and run software upgrade again. Do NOT restart or power off the analyzer immediately. 3、Requirements of the USB flash disk used in this upgrade. 1）Please use well-known brand USB flash disk. 2）Format(FAT32) the USB flash disk before use it. 3）Do NOT remove the USB flash disk during the upgrade.

3.1.2 Upgrade procedure 1、Copy the update file to a formatted USB flash disk. 2、Insert the USB flash disk into the USB interface of analyzer (See figure 3-1)

Figure 3-1 3、Log in the BC-3600 with Service Engineer username and password. 4、Run Setup Service Setup Setup Start Upgrade (see figure 3-2), and then click “Yes” in the dialog box (see figure 3-3).

3-1

Upgrade

Figure 3-2

Figure 3-3

NOTES: 1）Make sure the UBS storage connected well to the USB interface of the Analyzer. 2）After you click ‘Yes’ to start the upgrade, the system will start to read and analyze the configuration in the UBS storage and this will last for about 1min. Please wait for the pop-up upgrade confirmation dialog box. 3）Do NOT remove the USB flash disk during the upgrade.

3-2

Upgrade 5、software upgrade. 1) See the following software upgrade screen:

Figure 3-4 2) Click the ‘Upgrade’ button to start the upgrade. You will see the upgrade preparation dialog. (See figure 3-5)

Figure 3-5 3) The upgrade preparation lasts for about 1 min, after that, you will see the upgrade confirm dialog. (See figure 3-6)

Figure 3-6 4) Click ‘Yes’ to start the upgrade. (See figure 3-7)

3-3

Upgrade

Figure 3-7 5) You may need to restart the instrument for several times during the upgrade. (See figure 3-8)

Figure 3-8 6) Upgrade succeeded. (See figure 3-9)

Figure 3-9 7) Upgrade failed. (See figure 3-10)

3-4

Upgrade

Figure 3-10 8) After you finish all the process, please restart the instrument. (See figure 3-11)

Figure 3-11 6、After upgrade finished, log in with the service engineer username and password. Run Service Version to check upgrade items. (See figure 3-12)

Figure 3-12

3-5

Upgrade

3.1.3 Notes and Prompts of Errors 1、During the upgrade, the software will check whether the hardware and software are matched. If not, select the proper language, click OK to start upgrade. (See figure 3-13)

Figure 3-13 2、If upgrade failed, export the debug data. (See figure 3-14)

Figure 3-14

3-6

4

Mechanical System

4.1 Front of the Analyzer

Figure 4-1 Front of the analyzer(closed tube model)

1 --- Touchscreen

2 --- Indicator

3 --- Sample compartment door

4 --- USB interface

5 --- Recorder

4-1

Mechanical System

Figure 4-2 Front of the analyzer(open vial model)

1 --- Touchscreen

2 --- Indicator

3 --- Sample probe

4 --- Aspirate key

5 --- USB interface

6 --- Recorder

4-2

Mechanical System

4.2 Back of the Analyzer

Figure 4-3 Back of the analyzer

1 --- USB interface 1

2 --- USB interface 2

3 --- Network interface

4 --- Serial port

5 --- Power switch

6 --- Waste outlet

7 --- Rinse outlet

8 --- Diluent outlet

4-3

Mechanical System

4.3 Left of the Analyzer

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

1 --- Top cover

2 --- Front cover assembly

3 ---

4 --- Back panel assembly

Side door of electrical system

5 --- Bottom panel assembly

4-4

Mechanical System

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

1 --- Top cover

2 --- Front cover assembly

3 --- Side door of electrical system

4 --- Back panel assembly

5 --- Bottom panel assembly

4-5

Mechanical System

4.4 Right of the Analyzer

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

1 --- Top cover

2 --- Front cover assembly

3 ---

4 --- Door lock

Side door of fluidic system

5 --- Aspirate key

6 --- Back panel assembly

7 --- Bottom panel assembly

4-6

Mechanical System

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

1 --- Top cover

2 --- Front cover assembly

3 ---

4 --- Door lock

Side door of fluidic system

5 --- Aspirate key

6 --- Back panel assembly

7 --- Bottom panel assembly

4-7

5

Fluidic System

5.1 Fluidic Components and Functions 5.1.1 Sample Probe Aspirating and dispensing sample.

5.1.2 Probe Wipe Cleaning the exterior and interior walls of the sample probe.

5.1.3 Pump 

Gas pump (GP): provide pressure to the vacuum chamber for generation of bubbles.



Waste pump (LP): draining probe wipe, WBC bath, RBC bath and vacuum chamber and building vacuum.

5.1.4 Syringes 

Sampling syringe (Asp-Syringe): full measuring range is 100μl; aspirating fixed quantity of sample, dispensing the sample and aspirating the diluted sample again.



Diluent syringe (Dil-Syringe): full measuring range is 10ml; dispensing fixed quantity of diluent to WBC and RBC bath, providing diluent to probe wipe.



Lyse syringe (Lyse-Syringe): full measuring range is 2.5ml, motivated by the same motor with the diluent syringe; dispensing lyse.

5.1.5 Valves 

Fluid valve and magnetic valve: diaphragm form, controlled by electric magnetic power. Controlling the directional flow of fluid or air.

5.1.6 Baths 

WBC bath: composed of front bath, back bath and aperture. Providing room for the mixing of WBC sample; measuring HGB and WBC.



RBC bath: composed of front bath, back bath and aperture. Providing room for the mixing of RBC sample; measuring RBC/PLT.



Vacuum chamber: build and store stable vacuum for the impedance counting of WBC and RBC, clean the back baths and drain volumetric tubes.



Pressure chamber: build and store stable pressure for generation of bubbles in all baths.

5-1

Fluidic System 

WBC isolation chamber: providing air lock to block outside disturbance.



RBC isolation chamber: providing air lock to block outside disturbance.

5.1.7 Volumetric Tubes 

WBC volumetric tube: its volume is 300ul, measuring volume of the WBC sample to be analyzed.



RBC volumetric tube: its volume is 200ul, measuring volume of the RBC sample to be analyzed.

5.1.8 Filters 

Filter of WBC volumetric tube: filtrate the air entering the WBC volumetric tube.



Filter of RBC volumetric tube: filtrate the air entering the RBC volumetric tube.



GP filter: filtrate the air entering the gas pump.



Customized filter: filtrate the impurities and scraps from the probe wipe.



Filter of the isolation chamber: filtrate the impurities and scraps from the baths.

5.2 Reagent Consumption There are four counting modes: OV-WB, OV-PD, CT-WB and CT-PD. See Table 5- 1 for the reagent volume consumed in one analysis cycle of a sample. Table 5- 1Reagent consumed in one analysis cycle of a sample Reagent consumed in Item

one analysis cycle of a

Name

sample Whole blood

Predilute

Diluent

M-30D DILUENT

≤ 28mL

≤ 28mL

Lyse

M-30CFL LYSE

≤ 0.35mL

≤ 0.35mL

Rinse

M-30R RINSE

≤ 8mL

≤ 8mL

0

0

Probe cleanser

PROBE CLEANSER

Control

B30、BC-3D

/

Calibrator

S30、SC-CAL PLUS

/

5-2

Fluidic System

5.3 Sample Dilution Flowchart 5.3.1 Whole Blood Mode The whole blood analysis cycle completes in 60s. The analysis procedure is as follows: 1) Aspirate 17ul of sample, the sample probe ascends and the exterior wall of the probe is cleaned; 2) Dispense 6ul of sample to the probe wipe to wash it off; 3) Add diluent into the WBC bath and dispense 9ul of sample into the WBC bath, mix them to get the first dilution sample for WBC and HGB measurement. 4) The sample probe ascends and its exterior wall is cleaned, the residual sample is washed off by diluent in the probe wipe. 5) The sample probe descends to the WBC bath and aspirate 34ul of sample again, diluent is added and the second dilution sample is dispensed into the RBC bath, and mix them for RBC/PLT counting. 6) Add lyse into the WBC bath, and mix thoroughly; 7) Analyzing the sample; 8) When the analysis completes, clean and zap the WBC/RBC bath, release the pressure in the vacuum chamber. See Figure 5-1 for the dilution procedure of whole blood mode: Whole blood sample 9uL

8uL removed

Aspirate 17uL of blood

Diluent 1.15ml+1.2ml

The sample dilution ratio is 1：262.11

Aspirate 34uL of sample

1.8mL of diluent

0.8mL of mixture of blood and diluent

0.35ml of lyse

WBC sample dilution ratio is 1：302

RBC sample dilution ratio is 1：20000

Figure 5-1 Dilution procedure of whole blood mode

5-3

Fluidic System

5.3.2 Predilute Mode The predilute analysis cycle includes 3 function sequences (2 for closed tube models): diluent dispensing sequence, cleaning sequence (open vial models) and analyzing sequence. The procedure is as follows: 1) The sample probe dispense 380ul of diluent to a centrifugal tube and 20ul of sample in the capillary tube is added in to the centrifugal tube, mix them to form the diluted sample; 2) The sample probe aspirate 146.34ul of sample, and diluent is added into the WBC bath to form the first dilution sample for WBC and HGB measurement; 3) The sample probe ascends and its exterior and interior walls are cleaned; 4) The sample probe descends to the WBC bath and aspirate 37.39ul of sample again, diluent is added and the second dilution sample is dispensed into the RBC bath, and mix them for RBC/PLT counting. 5) Add lyse into the WBC bath, and mix thoroughly; 6) Analyzing the sample; 7) When the analysis completes, clean and zap the WBC/RBC bath, release the pressure in the vacuum chamber. You can see from the above procedures that the analysis cycles of predilute mode and whole blood mode are only different in the operations of sampling and dispensing into WBC bath, therefore this section will only introduce the different parts. See Figure 5-2 for the dilution procedure of predilute mode:

5-4

Fluidic System

Figure 5-2 Dilution procedure of predilute mode

5.4 Introduction of Fluidic Channels 5.4.1 WBC/HGB Channel 

All reagents:1)M-30PCFL lyse (lysing HGB, PLT and separating basophils from other WBCs ); 2) M-30PD diluent (cleaning, providing reaction and measurement environment)



Analysis principles: impedance method (analyzing WBC); colorimetric method (analyzing HGB)



Analysis parameters: WBC, HGB



Graphic information: WBC histogram



Dilution ratio:1:302 (WB); 1:369.77 (PD)



Measurement volume: 300μl



Function description: Mix 9ul of blood and 2.35ml of diluent in the WBC bath, provide 34ul of first dilution sample to the RBC bath and add 0.35ml of lyse into it, mix them; then aspirate the mixed sample into the back bath through the aperture by the vacuum of the vacuum chamber. The cells are analyzed when they pass the aperture. Volume of the sample analyzed is measured by the volumetric tube.

5-5

Fluidic System

5.4.2 RBC/PLT Channel 

All reagents: diluent (diluting, cleaning, providing conductive environment, isometric processing of cells)



Analysis principles: impedance method



Analysis parameters: RBC, PLT



Graphic information: RBC histogram, PLT histogram



Dilution ratio:1:20000 (WB); 1:22333.07 (PD)



Measurement volume: 200μl



Function description: the sample probe aspirates 34ul of sample (dilution ratio: 1:262.11) from the WBC bath, add 0.8ml of mixture of the sample and diluent into the RBC bath to form the sample of dilution ratio 1:20000 with another 1.8ml of diluent; Mix them and aspirate the sample by vacuum of the vacuum chamber into the back bath through the aperture. The cells are analyzed when they pass the aperture. Volume of the sample analyzed is measured by the volumetric tube.

5.5 Introduction of Basic Sequence 5.1.1 Whole Blood Analysis Sequence This section introduces the working procedure of sample probe in the measurement sequence first, then all the other working procedures are introduced in detail.

5.5.1.1 Sampling and dispensing procedure The working procedure of sample probe is indicated in Figure 5- 3. See section 5.3 for the sample dilution procedure. The working procedure of sample probe: a) Sample aspirating ① piercing(closed tube models) ② aspirating 17ul of sample. b) First dilution ① When aspiration finishes, the sample probe ascends; ② The sample probe moves to the top of the WBC bath; ③ The sample probe descends to the WBC bath and dispenses 9ul of sample. c) Aspirating sample from the WBC bath ① The sample probe ascends from the WBC bath, and removes the residual sample in the probe wipe; ② The sample probe descends to the WBC bath and aspirates 34ul of first dilution sample. d) Second dilution in the RBC bath ① When aspiration finishes, the sample probe ascends from the WBC bath; ② The sample probe moves to the top of the RBC bath; ③ The sample probe descends to the RBC bath, and dispenses 0.8ml of mixture of the sample and diluent. 5-6

Fluidic System ④ Initialize position of the sample probe by command INIT.

? ? RBC

WBC

Diluent

a)

?

Blood sample

b) ?

?

? RBC

RBC

WBC

c)

?

First dilutio n sampl e

Secon d dilution sample

? WBC

d)

Figure 5- 3 Sampling and dispensing procedure

5.5.1.2 The measurement procedure This section highlights the whole blood measurement sequence of the closed tube models. The measurement sequence consists of sample aspiration, dispensing, dilution, mixing, counting, and cleaning.

 Sampling (0~12.6s) 

The actions are: 

Pre-piercing: the pre-piercing process of sample probe (for closed tube models) to release the pressure in the tube before sample aspiration.

Cleaning the exterior and interior walls of sample probe: when piercing finishes, the sample probe ascends to home position, meanwhile its exterior and interior walls are washed. See the following figure.

5-7

Fluidic System V01

V01 Diluent V02

V02

V04

Diluent

V04 10ml

10ml 100ul

100ul

V19

V19

Waste

Waste a) Wash exterior wall of sample probe

b) Wash interior wall of sample probe

Figure 5- 4 Fluidic passages of sample probe cleaning 

The sample probe descends to the sampling position, and then moves to the piercing position, the syringe withdraws for 2ul to create separating bubbles. Then the sample probe descends to the lowest aspirating position to prepare for sample aspirating. Besides, the fluidic passages of draining and dispensing of the WBC bath are indicated in Figure 5- 5 and Figure 5- 6; Under the effect of vacuum, rinse flows through and washes the WBC and RBC back baths and their volumetric tubes, the fluidic passage of washing the WBC back bath and volumetric tube is indicated in Figure 5- 7; When the washing progress ends, Valve 5 and 6 opens to drain the volumetric tubes.

5-8

Fluidic System

V01 Diluent V04 V02

V03 10mL （SR3）

2.5mL (SR1)

WBC bath

Lyse

Isolation chamber

V16 Waste Figure 5- 5 Fluidic passage of draining of the WBC bath

V01 Diluent V04 V02

V03 2.5mL (SR1)

WBC bath

10mL （SR3）

lyse

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

5-9

Fluidic System

V05

V07

Atmosp heric pressure

WBC bath Volumetric board

Pressure

V14 Rinse Vacuum chamber

V09

Isolation chamber

V10 V18 V16

Waste

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

Aspirating sample: the sampling syringe aspirates 17ul of sample at 6.5~8.5s; and 800ul of diluent is added to the RBC bath after it is drained;



Ascending to home position: the sample probe ascends to home position at 9.3~11.6s, and its exterior wall is washed; by now, the sampling procedure is finished.



Other actions finished during the sampling procedure: 

After sample dispensing of the WBC bath finishes (7s) and the fluid level stabilizes, the HGB voltage and WBC aperture voltage (the constant-current source is opened at 10.5s in advance) is read at 10.5s.

 Sample Dispensing, Dilution and Mixing (11.5~30.8s)  

The actions are: Dispensing sample for the first time: the sample probe removes 6ul of sample in the probe wipe at 11.5~12.3s.



Dispensing sample for the second time: the sample probe moves to the top of WBC bath and descends into the bath; the diluent syringe dispenses 1150 ul of diluent into the WBC bath, then the sample probe dispensed 9 ul of sample and swings; when sample dispensing finishes, the diluent syringe dispenses 1200ul of diluent into the WBC bath again; Valve 10 opens, and blows one small bubble and 3 big bubbles into the WBC bath in turn. By now, the first dilution of sample finishes.



The sample probe ascends with its exterior and interior walls washed: when the second sample dispensing finishes, the sample probe ascends to home position with its exterior and interior walls washed; besides, 2700ul of diluent is dispensed into the RBC bath. 5-10

Fluidic System 

Second aspiration in the WBC bath: the sample probe descends to the WBC bath and aspirates 34 ul of fluid at 19.9~21s.Valve 17 opens, and the RBC bath is drained.



The sample probe ascends: when the second aspiration finishes, the sample probe ascends to home position with its exterior wall washed; besides, 1800 ul of diluent is added to the RBC bath at 24.5~25.5s.



Adding sample to RBC bath, and lyse to WBC bath: the sample probe moves to the RBC bath and descends into the bath; the lyse syringe dispenses 350ul of lyse into the WBC bath, the fluidic passage is indicated in Figure 5- 8; the diluent syringe discharges 800 ul of fluid (mixture of first dilution sample and diluent) through the sample probe. Valve 10 opens at 26.65~27.25s, the pressure chamber blows bubbles into the WBC bath; then a bubble that can last for 0.05s is blowed into the WBC bath, and 3 bubbles are blowed into the RBC bath in turn; Finally, the sample probe restores to the original position with its exterior wall washed.

V03 2.5mL (SR1) WBC bath

Lyse

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

Other actions finished during the sample dispensing, dilution and mixing procedure: 

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



Build the pressure needed for bubble generation;



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



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

 Analysis 

The actions are: 

Measuring volume of volumetric tube: valve 7 opens after WBC bubbling finishes for a while and valve 8 opens after RBC bubbling finishes for a while, the fluidic passage is indicated in Figure 5- 9; the closing of valve 7 and valve 8 is finished by the ending cleaning cycle started when the WBC and RBC down photocouplers are triggered. 5-11

Fluidic System

V05

V07

V06

V08

Volumetric board

RBC bath

WBC bath

Volumetric board

V14 Vacuum chamber

V15 Rinse

V18 Waste

Figure 5- 9 Fluidic passages of WBC and RBC analysis  

The photocoupler of volumetric board is opened at 25.7s.

Cleaning when analysis ends 

The actions are: 

The ending cleaning sequence is an independent sequence, it is started by the software automatically base on the information obtained during the analysis;



Fluid discharging of RBC and WBC baths: open valve 17, the RBC bath starts to discharge fluid; open valve 16, the WBC bath starts to discharge fluid;



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



Washing RBC and WBC back baths: when valve 8 and valve 15 open at the same time, the RBC back bath will be washed by rinse under the effect of vacuum; when valve 7 and valve 14 open at the same time, the WBC back bath will be washed by rinse under the effect of vacuum.



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



Resetting of the diluent syringe and sample probe assembly: the diluent syringe aspirates 2100 ul of fluid, then valve 1 opens, the syringe returns to home position and dispenses fluid to the RBC bath at the same time; the sample probe assembly returns to home position.



The sample probe aspirates air bar and returns to home position: the sample probe moves to the piercing position and withdraws for 2ul and then returns to home position.



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



Calculating the volume of rinse consumed: the software reads from the command to calculate the volume of rinse consumed.



Detecting rinse status: sensor in the analyzer detects if the rinse container is empty; when alarming for no rinse, the residual volume of rinse must be able to support the on-going analysis.

The major difference between the whole blood analysis sequences of open vial models and closed tube models lies in the sampling procedure, the open vial sequence involves no piercing action, but its sampling time point and the cleaning action after sampling are the same 5-12

Fluidic System with those of the closed tube sequence, therefore the whole blood analysis sequences of open vial models will not introduced in detail.

5.1.2 Predilute Measurement Sequence The predilute analysis cycle includes 3 function sequences (2 for closed tube models): diluent dispensing sequence, cleaning sequence (open vial models) and analyzing sequence. The predilute measurement procedure: (1)The sample probe dispense 380ul of diluent to a centrifugal tube and 20ul of sample in the capillary tube is added in to the centrifugal tube, mix them to form the diluted sample. (2)The sample probe aspirate 146.34ul of sample, and diluent is added into the WBC bath to form the first dilution sample for WBC and HGB measurement. (3)The sample probe ascends and its exterior and interior walls are cleaned. (4)The sample probe descends to the WBC bath and aspirate 37.39ul of sample again, diluent is added and the second dilution sample is dispensed into the RBC bath, and mix them for RBC/PLT counting. (5)Add lyse into the WBC bath, and mix thoroughly; (6)Analysis. (7)When the analysis completes, clean and zap the WBC/RBC bath, release the pressure in the vacuum chamber. You can see from the above procedures that the analysis cycles of predilute mode and whole blood mode are only different in the operations of sampling and dispensing into WBC bath, therefore this section will only introduce the different parts. See section 5.3.2 for the dilution procedure of predilute mode.

5.5.2.1 Dilution dispensing sequence The procedure is indicated in Figure 5- 10:

a) closed tube models

b) open vial models

Figure 5- 10 Diluent dispensing flowchart

5.5.2.2 Cleaning sequence after diluent dispensing Introduction: 5-13

Fluidic System 1. This sequence applies to open vial models only. 2. The sequence cleans the exterior wall of the sample probe, initializes diluent syringe by command INIT; the sampling syringe withdraws for 2ul to create a separating air bar, the system restores to "Ready" status.

5.5.2.3 Predilute Measurement Sequence Introduction: 

Sampling:

1. The diluent syringe withdraws for 100ul through the probe wipe tube; 2. WBC/RBC bath is zapped for 3s; 3. The diluent syringe aspirates 146.34ul of sample; 4. When aspirating finishes, valve 01 closes 0.1s after valve 04 closes. 

Sample dispensing of WBC bath:

1. The diluent syringe pushes sample in the sampling tube into the WBC bath to form the first dilution sample; 2. Sample volume of the second aspiration is 37.39ul; 3. The predilute measurement takes 1.5s more than the whole blood measurement due to the zapping action added before analysis; 4. The other parts of sequence are the same as those of the whole blood measurement sequence, only the fluid volumes are different in some steps. 5. The major difference between the closed tube and open vial models is the position of the sample probe under the "Ready" status.

5.1.3 Startup/Shutdown Sequence 5.5.3.1 Startup sequence There are three types of startup sequence: 1 startup after normal shutdown; 2 startup after abnormal shutdown; 3 startup after performing "Prepare To Ship" procedure. 

Startup after normal shutdown

This sequence includes the troubleshooting sequence 1, fluidics initializing sequence and startup sequence after normal shutdown. 1. Troubleshooting sequence 1, refer to the corresponding section. 2. Fluidics initializing sequence, refer to the corresponding section. 3. Startup after normal shutdown

5-14

Fluidic System

Figure 5- 11Startup procedure after normal shutdown Introduction: （1）

There are zapping and flushing operations at the beginning to avoid clogging after long term of probe cleanser soak.

（2）

0.5ml of lyse is discharged to make sure the tube mouth is filled with reagent.

（3）

Push back 200ul of diluent to the cleanser tube to wash off the cleanser at the closed end of valve 12.

（4）

Empty RBC charging line to avoid crystallizing of the cleanser spills on the wall of the bath which may influence the PLT background.

（5）

Empty the sample probe and dispense fluid: after emptying the sampling tube, 5-15

Fluidic System dispense fluid at a higher speed so that the bubbles in the sampling tube can be removed effectively. （6）

The sample probe dispenses fluid in the WBC bath: removing all the bubbles in the sampling tube.

（7）

Cleaning the two baths: cleanser volumes of WBC bath 4ml, 4.6ml, 5.5ml; cleanser volumes of RBC bath 4ml, 4ml, 5ml, generating bubbles during the cleaning process to strengthen the cleaning effect.

（8）

Emptying WBC, RBC baths and the back baths, switching among valve 16 ,17, 7 and 8 to strengthen the cleaning effect.



Startup after abnormal shutdown

This sequence includes the troubleshooting sequence 1, fluidics initializing sequence and startup sequence after normal shutdown. 1. Troubleshooting sequence 1, refer to the corresponding section. 2. Fluidics initializing sequence, refer to the corresponding section. 3. Startup after normal shutdown

Figure 5- 12 Startup procedure after abnormal shutdown Introduction: （1）

When starting up the analyzer after abnormal shutdown, there may be some

5-16

Fluidic System residual sample in the fluidic components, so the exterior and interior walls of the sample probe must be cleaned repeatedly by fluid discharging of the sample probe and probe wipe. （2）

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）

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

J 9

J12

J13

B

A

B

BN

A

AN

B

BN

A

B

BN

A

AN

J11 Air pump×1

Aspirate key switch

J6/J7 GND

J8 GND

GND

Aspirate signal

Volumetric signal

AN

B

BN

A

AN

D5V

GND

PGND

analog ± 12V power cord

JTAG/TTL electric level

J15

Drive board

FPGA

J4

UART/TTL electric level

Sample compartment connection board

J1

Photocoupler HOA0880T51(open vial×5， closed tube×6)

Sample compartment detection switch×4

Temper ature sensor ×1

VCC GND WORK FAULT

Indicator board

BUZ

J17

J18

nCS DCLK SDO SDI BUSY PENIRQ VDD GND

J5

J4

Data board

J30

J14

LCD_CTRL VBAT P12V PGND

USB×3 Network J22 port J12

RBC bath

WBC bath HGB bath

Recorder

#DOOR

GND

RXD

J14

TXD

GND

VCC

P12V

J7

PGND

J3

AGND

J2

HGB+ HGBHGB_IN

J1

WHOLE_B

Serial port

WHOLE_A

USB interface board

USB_VBUS GND USB_D+ USB_DSGND

AGND

Power board

J16

GND

J3

J14

Waste pump×1

AC120V zapping power cord

J1

AC power socket, filter and switch

P12V

J2

RHOLE_B

N L

J 4

RHOLE_A

AC input wire

J 2

Volumetric signal

J 5

D5V power cord

EMITTER GND DETECTOR GND

P12V/P24V power cord

Pressure signal of VC and PC

J 1

Customized valve (3-way magnetic valve×5， 2-way magnetic valve×13)

BN

Sample comparment motor×1(KA5 0KM2005,closed tube)

Sample probe motor×2 (43F4J-05-010, open vial & closed tube)

AN

Syringe motor×2(SST42D2120, open vial & closed tube)

Volumetric board

Door opening detection switch

Figure 6-2 Electric connection diagram of the hardware system

6-3

Touchscreen control board

Inverter

X+ Y+ XY-

H.V FB

Touchscreen VDD GND RXIN0+ RXIN0RXIN1+ RXIN1RXIN2+ RXIN2CLKOUT+ CLKOUT-

L C D display

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

Analog part Analog power

A±12V AC120V Analog power adjusting module

RBC/PLT sensor

RBC/PLT signal adjusting RBC/PLT constantcurrent source module and zap control module

WBC sensor

WBC signal adjusting

Gain control RBC PLT RBC/PLT HOLE constant-current source and zap control Gain control WBC WBC HOLE

Monitor module Digital part A/D

WBC constant-current source control and zap HGB control HGB sensor

HGB signal adjusting HGB luminotron constant-current source drive

Gain control HGB

GPIO

Drive control

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 Digital part

SRAM

DDR SDRAM

FLASH

AD module

SDRAMC

FEC

Interrupt

Display assembly

Flex Bus

PSC

CPU

CF card I2C

JTAG/configuration chip

Digital power

Recorder Power drive board

PCI

Volumetric board

Touchscreen control board

Ethernet port LIS

FPGA

Recorder

PHY

ISP1516

USB port

BDM

Real-time clock

BDM port

Figure 6-7 Structural diagram of the digital module The structure of the digital module is "CPU＋FPGA", see Figure 6-7.The functions of the digital module are: 

Preprocessing of data



Supporting peripherals interfaces 6-6

Hardware System 

Extending control interfaces

Description 

Adjusting analog power

Converting the input power into the power that meets the requirement of the board. 

Adjusting volume signal

Driving, collecting, adjusting, amplifying the RBC, PLT, WBC and HGB signals, and sending the signal to A/D part for conversion. 

Data collection

The A/D circuit converts the analog signals in to digital signals that can be recognized by the digital module (FPGA and CPU), and sends the signals to FPGA for processing. 

Preprocessing of data

The FPGA filters the digital signals collected by the A/D part, saves the particle parameters and sends the data to CPU through Flexbus by means like interrupt, etc. 

Supporting peripherals interfaces

The CPU module provides the platform for software operation to the system, and provides interfaces for peripherals, including interfaces of the drive board, LIS system, recorder, indicator board, touchscreen control board, LCD display, Ethernet, USB printer, USB barcode scanner, keyboard and USB, etc. It also provides JTAG interface for the online programming of FPGA configuration chip and BDM interface for CPU debugging. 

Extending control interfaces

The FPGA provides control logic and interfaces for LCD, recorder, CF card, touchscreen and door detector.

Definition of Interfaces There are 19 interface sockets on the data board, the functions of the interfaces are listed in Table 6-1. See Figure 6-8 for the position of the interfaces. Table 6-1 Functions of data board interfaces Interface

Function

No. of pins

Description

P1

Interface of CF card

50

/

J1

Interface of RBC/PLT sensor

3

Connect RBC/PLT sensor

J2

Interface of WBC sensor

4

Connect WBC sensor

J3

Interface of HGB sensor

4

Connect HGB sensor

J4

+/-12V power interface of the analog

3

Connect +/-12V analog

circuit

power

6-7

Hardware System

J5

120V power interface for aperture

3

zapping

Connect zapping power

J7

Interface of recorder

6

/

J8

JTAG interface for FPGA debugging

10

/

J9

Interface of LCD display

20

/

J12

RS232 serial port of LIS system

11

/

J13

BDM interface for CPU debugging

26

/

J14

Interface for door detector

2

/

J16

Interface of touchscreen control

24

/

board, indicator board and inverter J17

Interface of power drive board

20

/

J18

+5V, +12V power interface of the

4

/

analog circuit J20

Double-port USB-A interface

12

/

J22

Ethernet interface

10

/

J29

Single-port USB-A interface

6

/

J30

Single-port USB-A interface

6

/

6-8

Hardware System

J17

J14

J7

J16

J9

J8

J3

J4

J30

J29 J5 J20

J22

J2

J12

J1 J13

J18

P1

Figure 6-8 Position of the interfaces on the data board

6.2.3 Adjustment and Testing All the adjustable parameters of the board can be adjusted by command. You can set up the parameters on the software interface of the analyzer.

Function Definition of LEDs See Table 6-2 for the function definition of data board LEDs. Table 6-2 Function of data board LEDs Indicator

Function

+5V_POWER

＋5V power indicator of the digital circuit

+12V_POWER

＋12V power indicator of the digital circuit

FPGA_LED

Indicator of FPGA logical work, it filters when the logical work goes on normally

D3/D7/D8/D9

Indicator for software debugging

D17

-12V power indicator of the analog circuit

6-9

Hardware System

D20

+12V power indicator of the analog circuit

D21

-5V power indicator of the analog circuit

D22

+5V power indicator of the analog circuit

D38

Indicator for completing of FPGA configuration

D44

Indicator of network collision, flickers when collision occurs

D45

100M network indicator, flickers when transmitting data

D46

10M network indicator, flickers when transmitting data

D47

Indicator of network connection

D48

Indicator of the network full-duplex mode

D70

Power indicator of J30 single-port USB

D71/D72

Power indicator of J20 double-port USB

D73

Power indicator of J29 single-port USB

D100/D101

Connection indicator of J20 double-port USB

D102

Connection indicator of J29 single-port USB

D103

Indicator of USB-HUB chip connection

Function Definition of Test Points See Table 6-3 for the function definition of data board test points. Table 6-3 Function of data test points

No.

Name or location of test points

Description

1

VCC

Digital 5V power

2

VDD

Digital 3.3V power

3

D_1V8

Digital 1.8V power

4

D_1V5

Digital 1.5V power

5

D_2V5

Digital 2.5V power

6

D_1V25VRF

Digital 1.25V power

7

D_1V25VTT

Digital 1.25V power 6-10

Hardware System 8

D_1V2_FPGA

Digital 1.2V power

9

TP36

5V power of USB interfaces

10

TP37

5V power of USB interfaces

11

TP38

5V power of USB interfaces

12

TP39

5V power of USB interfaces

13

TP168

Voltage of button battery, 1.8V~4V

14

IRQ1

Interrupt signal when FPGA inputs to CPU

15

IRQ2

Interrupt signal when FPGA inputs to CPU

16

IRQ3

Interrupt signal when FPGA inputs to CPU

17

IRQ4

Interrupt signal when FPGA inputs to CPU

18

IRQ5

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

19

IRQ6

Interrupt signal when FPGA inputs to CPU

20

IRQ7

Interrupt signal when FPGA inputs to CPU

14

+12V

Analog 12V power

15

-12V

Analog -12V power

16

+5V

Analog 5V power

17

-5V

Analog -5V power

18

+56V

56V voltage of constant-current source

19

NCONST

On/off control signal of constant-current source, the RBC/WBC constant-current source is on when electrical level is low RBC constant-current source/zapping on/off control signal; zapping

20

NSEL_R

when the electrical level is low, RBC constant-current source when it is high WBC constant-current source/zapping on/off control signal; zapping

21

NSEL_W

when the electrical level is low, WBC constant-current source when it is high Zapping power on/off control signal, the zapping power is on when

22

NBURN

23

NHLED

24

RBC1

RBC signal that has been amplified (level 1)

25

RBC2

RBC signal that has been amplified (level 2)

26

RBC5

RBC signal that has been amplified (level 3)

27

RBC

Final output of RBC signal

28

RBCF

RBC signal at ADC entry

29

PLT1

PLT signal that has been amplified (level 1)

30

PLT2

PLT signal that has been amplified (level 2)

31

PLT

Final output of PLT signal

32

PLTF

PLT signal at ADC entry

33

WBC1

WBC signal that has been amplified (level 1)

34

WBC2

WBC signal that has been amplified (level 2)

35

WBC3

WBC signal that has been amplified (level 3)

the electrical level is low HGB lamp on/off control signal, the lamp is on when the electrical level is low

6-11

Hardware System 36

WBC

Final output of WBC signal

37

WBCF

WBC signal at ADC entry

38

HGB1

39

HGB

Final output of HGB voltage

40

VR_H

ADC reference source voltage of HGB channel

41

VR_W

ADC reference source voltage of WBC channel

42

VR_R

ADC reference source voltage of RBC channel

43

VR_P

ADC reference source voltage of PLT channel

44

HGND

Digital ground

45

-12VM

Monitoring voltage of analog -12V power

46

+12VM

Monitoring voltage of analog +12V power

47

+56VM

Monitoring voltage of 56V constant-current source

48

RHOLE

RBC aperture voltage

49

WHOLE

WBC aperture voltage

HGB voltage that has been amplified (primary level), normally it is negative

Note: refer to Table 6-3 for the location of all test points.

Definition of Keys See Table 6-4 for the definition of keys on the data board: Table 6-4 Definition of keys on the data board No.

Function

S12

Manual resetting of the system

6.2.4 Troubleshooting Table 6-5 lists the common errors and troubleshooting methods of the data board from the hardware point of view, the errors caused by software are not included. But many hardware errors must be inspected by the software. You need to check the following items before troubleshooting the errors: 1. Check if the wires are firmly connected to the data board; 2. Check if the wires are connected to the sockets of the same No., and if the wires are cracked or damaged. 3. Check if the input power of socket L18 is normal (test +5V and +12V with a multimeter). 4. Check if the indicator of the data board is in normal condition according to Table 6-5. After confirming all the above items are in normal condition, do as instructed in Table 6-5 to troubleshoot the errors. Table 6-5 Analyzing and handling data board errors No. 1

Phenomenon LCD

blanks

Judging criteria 1: Press the reset button S12 on the data board, if the

6-12

Solution Press S12

Hardware System out

error is cleared, it can be concluded as a program failure; if not, do step 2. Replug 2: Check if the data board if firmly connected to the inverter and LCD display. Replug the connection wires, if the error is cleared, it can be concluded as an insecure connection error; if not, do step 3.

the

connection wires

of

the

data board and the

inverter

and

LCD

display. Replace 3: Replace the connection wires of the data board and the inverter and LCD display, if the error is cleared, it can be concluded as a connection wire failure; if not, do step 4.

the

connection wires

of

the

data board and the

inverter

and

LCD

display. 4：Test the resistance of F4 with multimter, if the result is not 0, the error is caused by the protective tube F4; if not, do step 5. 5: Test voltage of the test point VDD with the multimeter, if the result is not 3.135V~3.465V, U62 failure can be concluded; if not, do step 6. 6: Test voltage of the test point D_2V5 with the multimeter, if the result is not 2.375V~2.625V, U60 failure can be concluded; if not, do step 7. Replace 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

data board

the

Hardware System

10: Test voltage of R27 with the multimeter, if the result is 0V, then X6 failure can be concluded; if not, do step 11. 11: Test voltage of R27 with the multimeter, if the result is 1.6V, but the voltage of R31 is 0V, then U11 failure can be concluded; if not, do step 12. 12: Test voltage of R273 with the multimeter, if the result is 0V, then X2 failure can be concluded; if not, do step 13. 13: If D38 is off, reprogram correct version of FPGA logic; if D38 is still off, then FPGA chip (U49) failure can be concluded; if not, do step 14. 14: Replace LCD display and the inverter (display

Replace

assembly), if the error is cleared, then the display

display

assembly failure can be concluded.

assembly

the

Replug 1: Replug the connection wires of the data board and the inverter and LCD display, if the error is cleared, it can be concluded as an insecure connection failure; if not, do step 2.

the

connection wires

of

the

data board and the

inverter

and

LCD

display. Replace 2: Replace the connection wires of the data board and 2

LCD display

the inverter and LCD display, if the error is cleared, it

flickers

can be concluded as a connection wire failure; if not, do step 3.

the

connection wires

of

the

data board and the

inverter

and

LCD

display. 3: Replace the data board, if the error is cleared, the display memory (U4) failure or crystal oscillator (X6) failure can be concluded; if not, do step 4.

Replace data board

4: Replace the inverter and LCD display (display

Replace

assembly), if the error is cleared, then the display

display

assembly failure can be concluded.

assembly

6-14

the

the

Hardware System

1: Check if the data board if firmly connected to the LCD display. Replug the connection wires, if the error is cleared, it can be concluded as an insecure connection error; if not, do step 2.

Replug

the

connection wire of the data board and LCD display Replace

3

2: Replace the connection wires of the data board and

connection

the LCD display, if the error is cleared, it can be

wire of the data

concluded as a connection wire failure; if not, do step 3.

board and LCD display

Spotted LCD display

the

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

Cut

off

solder

the joint

with a knife.

4: Replace the data board, if the error is cleared, the

Replace

data board failure can be concluded; if not, do step 5.

data board

5: Replace the inverter and LCD display (display

Replace

assembly), if the error is cleared, then the display

display

assembly failure can be concluded.

assembly

the

the

1: Check whether the IP set on the PC is in the same network segment (10.0.0.x) as the data board, if not, reset the IP of the PC to 10.0.0.3. If the error is cleared, then failure of incorrect IP address can be concluded; if

Set IP of the PC to 10.0.0.3

not, do step 2. Fail to 3

connect

2: D47 and D48 is off when power is connected,

network

network chip (U36) failure can be concluded, or else, do step 3.

2: D47 and D48 is on, poor connection of the network wire, or the wire is damaged.

The USB 5

interfaces cannot be used

1: Check if the kernel software version of MCU and the data board version are matched. View the kernel version information by click "Service-> Version Info. " on the analyzer screen. If result is not matched, upgrade the kernel to the correct version; or else, do step 2.

6-15

Replace

the

data board

Replug

or

replace

the

network wire

Upgrade

the

kernel to the correct version.

Hardware System

2: When power is connected, D70, D71, D72 and D73 are not all on, USB power chip or PCI-to-USB chip failure can be concluded, or else, do step 3. 3: When power is connected, D70, D71, D72 and D73 are all on but hot, the U85 and U86 failure can be concluded, or else, do step 4.

Replace

the

data board

Replace

the

data board

4: When power is connected, D70, D71, D72 and D73

Replug

are all on, replug the wire connected to the USB port. If

wire connected

the error is cleared, it can be concluded as an insecure

to

connection error; if not, do step 5.

port

5: When power is connected, D70, D71, D72 and D73 are all on, replace devices connected to the USB port (mouse, keyboard or USB). If the replaced ones can be used, then the device failure can be concluded; if not, do step 6.

the

the USB

Replace devices connected

to

the USB port

6: When power is connected, D70, D71, D72 and D73 are all on, test the USB port with a USB mouse or keyboard, if they can be used, but the USB printer cannot be used, check if the connection wire is marked with 1P/28AWG+2C/24AWG, USB SHIELDED HIGH SPEED, USB 2.0 VERSION. If not, replace the connection wire of the printer. If the error is cleared, the

Replace

the

connection wire of printer with a qualified one

connection wire failure can be concluded. 1: Test voltage of pin 1 or pin 4 of X5 with the multimeter, if the result is 0V, then X5 failure can be The clock 6

concluded; if not, do step 2.

Replace

the

data board

resets each time after

2: Cut off the power, test the voltage of capacitor C24

startup

with the buttery on by a multimater, if the result is