Mindray BA-88A Service Manual

BA-88A Semi-auto Chemistry Analyzer

Service Manual

i

© 2008-2009 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2009-03 (Version: 1.1).

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, rental, adaption and translation of this
manual in any manner whatsoever without the written permission of Mindray is strictly
forbidden.

, , , , , BeneView, WATO,

BeneHeart, 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 the effects on safety, reliability and performance of this product,
only if:

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

product are conducted by Mindray authorized personnel;

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

and local requirements;

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

ii

NOTE:

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

WARNING:

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

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.

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 Return authorization: Contact the Customer Service Department and obtain

a Customer Service Authorization number. This number must appear on the
outside of the shipping container. Returned shipments will not be accepted if
the number is not clearly visible. Please provide the model number, serial
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 the Customer Service department

iii

Company Contact

Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan, ShenZhen518057, P.R. China

Tel:

[phone] 26582888

Fax:

[phone] 26582500

EC Representative

Name:

Shanghai International Holding Corp. GmbH
(Europe)

Address:

Eiffestraβe 80, 20537Hamburg, Germany

Phone:

0049-40-2513175

Fax:

0049-40-255726

Foreward 1

Foreword

Who Should Read This Manual

This manual is geared for service personnel authorized by Mindray.

What Can You Find in This Manual

This manual covers principles, installation procedures, theories, maintenance and
troubleshooting guidelines of the BA-88A. Please service the system strictly as instructed
by this manual.

Conventions Used in This Manual

This manual uses the following typographical conventions to clarify meanings in the text.
Bold and Italic font indicates text displayed on the screen, such as Sample Request.

Safety Symbols

This chart explains the symbols used in this manual.

When you see… Then…

WARNING

Read the statement following the symbol. The
statement is alerting you to an operating hazard
that can cause personal injury.

BIOHAZARD

Read the statement following the symbol. The
statement is alerting you to a potentially
biohazardous condition.

CAUTION

Read the statement following the symbol. The
statement is alerting you to a possibility of system
damage or unreliable results.

NOTE

Read the statement following the symbol. The
statement is alerting you to information that
requires your attention.

Labels Used On the System

The labels attached to the panels of the system use symbols to clarify the meaning of the
text. The chart below explains the symbols on the labels.

Serial Number

Foreward 2

Date of Manufacture

Manufacturer
CE marking. The device is fully in conformity with the

Council Directive Concerning In Vitro Diagnostic
Medical Devices 98/79/EC.

Authorized Representative in the European
Community

The following definition of the WEEE label applies to
EU member states only: The use of this symbol
indicates that this product should not be treated as
household waste. By ensuring that this product is
disposed of correctly, you will help prevent bringing
potential negative consequences to the environment
and human health. For more detailed information with
regard to returning and recycling this product, please
consult the distributor from whom you purchased the
product.

In Vitro diagnostic equipment

Biohazard warning: risk of potentially biohazardous
infection

Warning: Risk of personal injury or equipment damage

Protective ground terminal

ON (Power)

Graphics

All graphics, including screens and printout, are for illustration purposes only and must
not be used for any other purpose.

EC Representative

Name: Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestraβe 80, 20537 Hamburg Germany
Phone: [phone]
Fax: [phone]

Foreward 3

Safety Precautions

Observe theses safety precautions when using the system. Ignoring any of the
precautions may lead to personal injury or equipment damage.

WARNING

If the instrument is used in a manner not specified by our company, the
protection provided by the system may be impaired.

Preventing Electric Shock

Please observe the following instructions to prevent electric shock.

WARNING

When the instrument is turned on, users must not open the cover.
Spillage of reagent or sample on the analyzer may cause equipment

failure and even electric shock. Do not place sample and reagent on
the analyzer. In case of spillage, switch off the power immediately,
remove the spillage and contact our company customer service
department or your local distributor.

This instrument is supplied with a slow-blow fuse (250V, 3.15A), which
must not be replaced by the user.

Power supply: 100-240V~, 50/60Hz.
The instrument is supplied with a three-wire power cord and should be

properly grounded during application.

Preventing Personal Injury Caused by Moving Parts

Please observe the following instructions to prevent personal injury caused by moving
parts.

WARNING

Do not put your finger or hand into any open part when the system is in
operation.

Foreward 4

Preventing Personal Injury Caused by Photometer Lamp

Please observe the following instructions to prevent personal injury caused by
photometer lamp.

WARNING

Light sent by the photometer lamp may hurt your eyes. Do not stare into
the lamp when the system is in operation.

If you want to replace the photometer lamp, first switch off the Main
Power and then wait at least 15 minutes for the lamp to cool down
before touching it. Do not touch the lamp before it cools down, or you
may get burned.

Preventing Infection

Please observe the following instructions to protect against the biohazardous infection.

BIOHAZARD

Inappropriately handling samples may lead to biohazardous infection. Do
not touch the sample, mixture or waste with your hands. Wear gloves and
lab coat and, if necessary, goggles.

In case your skin contacts the sample, follow standard laboratory safety
procedures and consult a doctor.

Handling Reagents and Wash Solution

WARNING

Reagents and enhanced wash solution may hurt human skins. Exercise
caution when using the reagents and enhanced wash solution. In case
your skin or clothes contact them, wash them off with clean water. In
case the reagents or wash solution spill into your eyes, rinse them with
much water and consult an oculist.

Foreward 5

Treating Waste Liquids

Please observe the following instructions to prevent environmental pollution and personal
injury caused by waste.

BIOHAZARD

Some substances in reagent, control, enhanced wash solution and
waste are subject to regulations of contamination and disposal. Dispose
of them in accordance with your local or national guidelines for
biohazard waste disposal and consult the manufacturer or distributor of
the reagents for details.

Wear gloves and lab coat and, if necessary, goggles.

Treating Waste Analyzer

Please observe the following instructions to dispose of the waste analyzer.

WARNING

Materials of the analyzer are subject to contamination regulations. Dispose
of the waste analyzer in accordance with your local or national guidelines
for waste disposal.

Preventing Fire or Explosion

Please observe the following instructions to prevent fire and explosion.

WARNING

Ethanol is flammable substance. Please exercise caution while using the
ethanol.

Foreward 6

Precautions on Use

To use the system safely and efficiently, please pay much attention to the following
operation notes.

Intended Use

WARNING

The system is an analyzer designed for in vitro quantitative
determination of clinical chemistries in serum, plasma, urine and CSF
samples. Please consult Mindray first if you want to use the system for
other purposes.

To draw a clinical conclusion, please also refer to the patient’s clinical
symptoms and other test results.

Operator

WARNING

The system is to be operated only by clinical professionals, doctors or
laboratory experimenters trained by our company or our authorized
distributors.

Environment

CAUTION

Please install and operate the system in an environment specified by this
manual. Installing and operating the system in other environment may lead
to unreliable results and even equipment damage.

To relocate the system, please contact our customer service department or
your local distributor.

Foreward

7

Preventing Interference by Electromagnetic Noise

CAUTION

Electromagnetic noise may interfere with operations of the system. Do
not install devices generating excessive electromagnetic noise around
the system. The electromagnetic environment should be evaluated
prior to operation of the device. Do not use such devices as mobile
phones or radio transmitters in the room housing the system. Do not
use other CRT displays around the system. The electromagnetic noise
might lead to system failures.

Do not use other medical instruments around the system that may
generate electromagnetic noise to interfere with their operations.

NOTE

It is the manufacturer's responsibility to provide equipment
electromagnetic compatibility information to the customer or user.

NOTE

It is the user's responsibility to ensure that a compatible
electromagnetic environment for the equipment can be maintained in
order that the device will perform as intended.

Operating the System

CAUTION

Operate the system strictly as instructed by this manual. Inappropriate use
of the system may lead to unreliable test results or even equipment
damage or personal injury.

Before using the system for the first time, run the calibration program and
QC program to make sure the system is in normal status.

Be sure to run the QC program every time you use the system, otherwise
the result may be unreliable.

Do not touch the screen with wet hands or hands contaminated by
chemicals.

Do not place the Power to ON again within 10 seconds since placing it to
OFF;

Foreward 8

Maintaining the System

CAUTION

Maintain the system strictly as instructed by this manual. Inappropriate
maintenance may lead to unreliable results, or even equipment damage
and personal injury.

To wipe off dust from the system surface, use a soft, clean and wet (not too
wet) cloth, soaked with mild soap solution if necessary, to clean the
surface. Do not use such organic solvents as ethanol for cleaning. After
cleaning, wipe the surface with dry cloth.

Switch off all the powers and unplug the power cord before cleaning. Take
necessary measures to prevent water ingression into the system,
otherwise it may lead to equipment damage or personal injury.

Replacement of such major parts as lamp assembly must be followed by a
calibration.

Check the pump tubing for leakage as needed and replace the tubing in
time. Otherwise, the normal aspiration of the system might be affected. It is
recommended that the inner system tubing should be replaced every 24
months to avoid possible blockage or invalidation brought about by aging.

Setting up the System

CAUTION

To define such parameters as calculation method and wavelength, follow
the instructions in this manual and the package insert of the reagents.

Foreward 9

Samples

CAUTION

Use samples that are completely free of insoluble substances like fibrin, or
suspended matter; otherwise the probe may be blocked.

Medicines, anticoagulants or preservative in the samples may lead to
unreliable results.

Hemolysis, icterus or lipemia in the samples may lead to unreliable test
results, so a sample blank is recommended.

Store the samples properly. Improper storage may change the
compositions of the samples and lead to unreliable results.

Sample volatilization may lead to unreliable results. Do not leave the
sample open for a long period.

Some samples may not be analyzed on the system based on parameters
the reagents claim capable of testing. Consult the reagent manufacturer or
distributor for details.

Certain samples need to be processed before being analyzed by the
system. Consult the reagent manufacturer or distributor for details.

Reagents, Calibrators and Controls

CAUTION

Use appropriate reagents, calibrators and controls on the system.
Select appropriate reagents according to performance characteristic of the

system. Consult the reagent suppliers, our company or our authorized
distributor for details, if you are not sure about your reagent choice.

Store and use reagents, calibrators and controls strictly as instructed by
the suppliers. Otherwise, you may not obtain reliable results or best
performance of the system.

Improper storage of reagents, calibrators and controls may lead to
unreliable results and bad performance of the system even in validity
period.

Perform a calibration after changing reagents. Otherwise, you may not
obtain reliable results.

Contamination caused by carryover among reagents may lead to
unreliable test results. Consult the reagent manufacturer or distributor for
details.

Foreward 10

External Equipment

WARNING

External equipment connected to the analogue and digital interfaces
must be complied with the relevant Safety and EMC standards (e.g., IEC
60950 Safety of Information Technology Equipment Standard and CISPR
22 EMC of Information Technology Equipment Standard (CLASS B)).
Any person, who connects additional equipment to the signal input or
output ports and configures an IVD system, is responsible for ensuring
that the system work normally and complies with the safety and EMC
requirements. If you have any problem, consult the technical services
department of your local representative.

Communication interface

CAUTION

The system is equipped with two USB ports which can be used in
connecting the keyboard, mouse, printer and other external
equipments or in system upgrading. RS232 is used in connecting the
PC with the analyzer to transfer data.

These three ports should not be used to operate the system for usage
other than those mentioned above. Otherwise, system might be
damaged.

Contents

I

Contents

Contents.................................................................................................................. I

1

System Specifications .............................................................................. 1-1

1.1 System specifications............................................................................................. 1-1

1.2 Parameters ............................................................................................................ 1-1

1.3 Instrument Configuration ........................................................................................ 1-2

1.4 Overview................................................................................................................ 1-2

2

System Installation.................................................................................... 2-1

2.1 Basic...................................................................................................................... 2-1

2.2 Installation Procedures........................................................................................... 2-2

3

System Description................................................................................... 3-1

3.1 Operating Procedures ............................................................................................ 3-1

3.2 Component Structure and Functions....................................................................... 3-2

3.2.1 Photometer Assembly................................................................................ 3-2

3.2.2 Lamp assembly ......................................................................................... 3-3

3.2.3 Lamp Base Assembly ................................................................................ 3-5

3.2.4 Flow Cell Base Assembly........................................................................... 3-9

3.2.5 Base Plate Assembly............................................................................... 3-12

3.2.6 Enclosure Assembly ................................................................................ 3-13

4

Hardware....................................................................................................4-1

4.1 Overview................................................................................................................ 4-1

4.2 Safety Precautions................................................................................................. 4-1

4.3 Introduction of the Modules .................................................................................... 4-1

4.4 CPU Board............................................................................................................. 4-2

4.4.1 LED Indicator............................................................................................. 4-2

4.4.2 Memory Module......................................................................................... 4-2

4.4.3 Clock Module............................................................................................. 4-3

4.4.4 Interface Module........................................................................................ 4-3

4.5 CPU Extension Board ............................................................................................ 4-3

4.5.1 Overview ................................................................................................... 4-3

4.5.2 LED Indicator............................................................................................. 4-4

4.5.3 USB Functions........................................................................................... 4-4

4.5.4 LCD&Touchscreen Driver Control .............................................................. 4-5

4.5.5 Serial Port Communication ........................................................................ 4-5

4.5.6 Driver of the Step Motor............................................................................. 4-6

4.5.7 Driver of the Peristaltic Pump..................................................................... 4-6

4.5.8 Driver of the Refrigeration Plate ................................................................. 4-6

4.5.9 Detection of the Input Signal ...................................................................... 4-7

4.5.10 Analogue Board Control........................................................................... 4-7

Contents II

4.6 Analogue Board ..................................................................................................... 4-7

4.7 LCD&Touchscreen Board....................................................................................... 4-8

4.8 Power board .......................................................................................................... 4-9

4.8.1 Overview ................................................................................................... 4-9

4.8.2 The Basic Feature of the Power Module..................................................... 4-9

4.9 LCD Background Adjustment ............................................................................... 4-10

4.10 Connection of the Hardware System..................................................................4-11

4.10.1 Definition of the CPU Board + CPU Extension Board Interface................4-11

4.10.2 Analogue Board Interface ...................................................................... 4-12

4.10.3 Power Board Interface ........................................................................... 4-12

4.10.4 LCD&Touchscreen Board Interface ........................................................ 4-13

5

Service and Maintenance..........................................................................5-1

5.1 Maintenance .......................................................................................................... 5-2

5.1.1 Daily Maintenance ..................................................................................... 5-2

5.1.2 Weekly Maintenance.................................................................................. 5-2

5.1.3 Irregular Maintenance................................................................................ 5-2

5.2 Software Upgrading................................................................................................ 5-3

5.2.1 Software Structure..................................................................................... 5-3

5.2.2 Software List.............................................................................................. 5-4

5.2.3 Upgrading Procedures for Software on CPU Board.................................... 5-5

5.2.4 Upgrading Procedures for Software on CPU Extension Board.................... 5-7

5.3 Maitenance .......................................................................................................... 5-12

5.3.1 Replacing the tubing................................................................................ 5-12

5.3.2 Replacing Aspiration Tubing..................................................................... 5-16

5.3.3 Replacing Lamp....................................................................................... 5-17

5.3.4 Replacing CPU Board.............................................................................. 5-19

6

Troubleshooting ........................................................................................6-1

6.1 Alarm Message Classification................................................................................. 6-1

6.2 Levels.................................................................................................................... 6-1

6.2.1 Errors to Warn User (0).............................................................................. 6-2

6.2.2 Errors to Invalidate Tests(1) ....................................................................... 6-2

6.2.3 Errors to Forbid Test(2).............................................................................. 6-2

6.3 Error Display.......................................................................................................... 6-2

6.3.1 Dialog Box................................................................................................. 6-2

6.3.2 Sound........................................................................................................ 6-2

6.4 Details.................................................................................................................... 6-3

1 Systemystem Specifications 1-1

1 System Specifications

1.1 System specifications

 Dimension: ≤420mm ×350mm ×158mm(L×W×H)
 Weight: ≤7Kg
 Power supply: 100-240V～, 50/60Hz;
 Power consumption: maximum 140VA;
 Operating methods: touchscreen, USB key board and mouse.

1.2 Parameters

 Reaction type: Endpoint, Kinetics, Fixed-time, Absorbance;
 Analyzing methods: single/double- wavelength;
 Clinical chemistries, immunoassays, TDM (Therapeutic Drug Monitoring)
 Aspiration volume: 200μl-9000μl ;

 Temperature: room temperature, 25℃, 30℃, 37℃;
 Capable of storing and outputting various data and tables/graphs, and

calculating among different tests

 Storage capacity: capable of storing more than 3000 test results.

1 Systemystem Specifications 1-2

1.3 Instrument Configuration

 Wavelengths: 6 wavelengths (available): 340nm, 405nm, 510nm, 546nm,

578nm and 630nm.2 wavelengths (optional): 450nm and 670nm.

 Reaction container: flow cell or cuvette.
 Printing: thermal recorder.

1.4 Overview

 Colorimetric system: The colorimetric analysis is realized through the

combination of optical collimating, mono-color filter, mechanical parts and
software, hardware module.

 Aspiration system: it is used to aspirate the matter to be tested or to wash the

tubing system (only for flow cell system).

 Software/hardware system: it is used to set tests, enter operating instructions,

control the data collection, calculate and save the results.

2 System Installation 2-1

2 System Installation

2.1 Basic

 Make sure the installation site of the hospital meet the system installation

requirements on space, power supply and environment. Please refer to the
operator’s manual for details.

 If data management software or test and maintaenance software is used on PC,

please make sure the configuration of the PC meet the system requirement.

1 PC requirement for test and maintenance software:

 CPU: Celeron 1.7 or above;
 Memory: 256M or above;
 Resolution of the screen: 1024*768;
 Operating system: windows 2000(professional/server SP4), windows

xp(home/professional SP1 or above)
 Communication interface: RS-232C
2 PC requirement for data management software:

 CPU: Pentinum II or above;
 Memory: at least 1G for Vista operating system; at least 512 M for other

operating system.

 Resolution of the screen: 1024*768 or above;
 Operating system: Windows XP/Vista/Windows 2000

2 System Installation 2-2

 Databse: SqlServer 2005 Express
 Network communication: 10/100M 10/100M
 Communication interface: RS-232C
 Hard disk ( the disk on which the software is installed): 10G
 Printer (connected with PC)

2.2 Installation Procedures

1 When you receive the system, carefully inspect the package. After opening

the package, check the delivered goods against the packing list.

2 Move the instrument to the installation site and remove all the package and

protective materials.
3 Connect the instrument to waste container.
4 Connect the power cable and power on the analyzer. After self-check and

tubing wash is completed, the main screen is displayed.
5 After the system is stable, request one or two routine tests and run. Assess

the test results. Please refer to the operator’s manual for details.
6 Follow the normal procedure to shutdown the analyzer.
7 Training:

Can the customer complete daily tests?

Yes □ No □

Is the customer familiar with the daily, weekly and monthly maintenance and

relevant maintenance methods? Yes □ No □

Is the customer familiar with cleaning and washing the system?

Yes □ No □

Is the customer familiar with troubleshooting the common failures?

Yes □ No □

Is the customer familiar with replacing the peristaltic pump tubing and

calibrating the flow volume? Yes □ No □

Is the customer familiar with replacing the aspiration tubing? Is the customer

familiar with replacing the lamp? Yes □ No □

3 System Description 3-1

3

System Description

3.1 Operating Procedures

The typical operating procedure of BA-88A is shown as follows:
Figure 3-1 Operating procedure

Lamp
stabilization

Reaction

All the

tests

finished

Temperature
stabilization

Other
tests

Procedures:

1 Empty the waste. Connect the waste tubing to the waste container. Prepare

the samples, reagents and distilled water;

2 Connect power cable correctly. Power on the analyzer. The instrument will

under go the initialization processes, including; system startup, hardware
self-check, parameters download, dark current testing. After initialization,
wait until the temperature and the light source are stable. The whole
process lasts for about 15 minutes;

3 After the system is stable, set the parameters of the tests, such as

wavelength, temperature, methods and etc. Start the test.

3 System Description 3-2

4 After the test is completed, run other tests if necessary. Washing should be

inserted between two tests to minimize the carryover, when the
concentrations of the two tests are too different or the two tests are different.

5 After all the tests are completed, shutdown the analyzer. Cut off the

instrument power after washing is completed.

3.2 Component Structure and Functions

3.2.1 Photometer Assembly

3.2.1.1 Introduction

Photometer assembly is the core of BA-88A, integrating optical system, temperature
control system and photoelectrical collection system. The photometer assembly is the
key for reliability of the system. Photometer assembly includes lamp assembly, lamp
base assembly, flow cell assembly and other components, which are used to position
and install the optical components, thermal components and analogue board.

3.2.1.2 Components and Structure

The basic structure of the photometer assembly is shown as figure 3-2.
Figure 3-2 Photometer assembly structure

3.2.1.3 Assembly and Disassembly of the Photometer
Assembly

Photometer assembly is fixed on the instrument base by 3 M4 socket head screws.