Mindray BA-88A User manual

BA-88A Semi-auto Chemistry Analyzer
Operation Manual

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© 2008 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2008-09 (Version: 1.0).
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this
manual. This manual may refer to information protected by copyrights or patents and
does not convey any license under the patent rights of Mindray, nor the rights of
others. Mindray does not assume any liability arising out of any infringements of
patents or other rights of third parties.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the
written permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, 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.

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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

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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, Hamburg 20537, Germany
Phone: [phone]
Fax: [phone]

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Preface
Before using the system, please read this operation manual thoroughly for relevant operation instructions.
Please keep this manual properly for convenient use.
Intended Reader
This manual is geared for clinical professionals to:
Operate the system;
Maintain and troubleshoot the system;
Learn about the system operation.
What Can You Find in This Manual
The system should be operated and maintained strictly as instructed by this manual. This operation manual
covers principles, operations, daily maintenance and troubleshooting of the equipment. Please operate and
service the equipment strictly as instructed by this manual.
Conventions
Safety Symbols
Safety symbols alert you to potentially dangerous conditions and information that requires your attention.
These safety symbols, together with related text, apply to specific procedures and appear as needed
throughout 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.
NOTE
Read the statement following the symbol. The
statement is alerting you to information that
requires your attention.
CAUTION
Read the statement following the symbol. The
statement is alerting you to a possibility of system
damage or unreliable results.

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Labels
The labels attached to the surface of the instrument use symbols to clarify the
meaning of the text. If any of the labels peels off, contact our company customer
service department or your local distributor for replacement. The chart below
explains the symbols on the labels.
Serial number
Manufacture date
Manufacturer
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
Protective ground terminal
Warning: Risk of personal injury or equipment
damage
100-240V～,50/60Hz AC 100-240V, 50/60Hz
Power ON
Power OFF
Serial port to connect the equipment to PC
USB port, which complies with the USB 2.0
protocol.

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

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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.

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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.

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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.

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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.
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.

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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;

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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.

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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.

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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.

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Contents
Preface ............................................................................................................................... 1
Contents .............................................................................................................I
1System Description ..............................................................................1-1
1.1 Introduction ........................................................................................................... 1-1
1.1.1 Overview.................................................................................................. 1-1
1.1.2 Outlook .................................................................................................... 1-1
1.2 Parameters ........................................................................................................... 1-3
1.3 Touchpen and Popup Keypad .............................................................................. 1-3
1.3.1 Touchpen ................................................................................................. 1-3
1.3.2 Popup Keypad ......................................................................................... 1-4
1.4 Printer ................................................................................................................... 1-4
1.4.1 Internal Thermal Recorder....................................................................... 1-4
1.4.2 External Printer ........................................................................................ 1-5
2Installation.............................................................................................2-1
2.1 Unpacking............................................................................................................. 2-1
2.2 Installation............................................................................................................. 2-1
2.2.1 System Specifications.............................................................................. 2-1
2.2.2 Environmental Requirements .................................................................. 2-1
2.2.3 Space and Accessibility Requirements.................................................... 2-2
2.2.4 Water Requirements................................................................................ 2-2
2.2.5 Waste Bottle............................................................................................. 2-2
2.3 Installation............................................................................................................. 2-3
2.3.1 Connecting Power Cord .......................................................................... 2-3
2.4 Storage for a Short Period .................................................................................... 2-4
2.5 Storage for Long Period........................................................................................ 2-4
3Basic Operations ..................................................................................3-1
3.1 Preparation for Powering On ................................................................................ 3-1
3.2 Timing Principle .................................................................................................... 3-2
3.2.1 Flow Cell Mode ........................................................................................ 3-2
3.2.2 Cuvette Mode .......................................................................................... 3-5
3.3 Edit........................................................................................................................ 3-6
3.4 Shutdown.............................................................................................................. 3-6
4Advanced Operations...........................................................................4-1
4.1 Powering On ......................................................................................................... 4-1
4.2 Parameter ............................................................................................................. 4-2

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4.2.1 Routine..................................................................................................... 4-2
4.2.2 Profile.......................................................................................................4-9
4.2.3 Calculation ...............................................................................................4-9
4.2.4 Off-system..............................................................................................4-12
4.3 Test .....................................................................................................................4-13
4.3.1 Request.................................................................................................. 4-13
4.3.2 Test ........................................................................................................4-15
4.4 Calibration...........................................................................................................4-19
4.5 QC....................................................................................................................... 4-22
4.6 Result..................................................................................................................4-23
4.6.1 Result.....................................................................................................4-24
4.6.2 Edit.........................................................................................................4-27
4.7 Setup...................................................................................................................4-30
4.7.1 Basic ......................................................................................................4-31
4.7.2 Dictionary ............................................................................................... 4-32
4.7.3 Print Features ........................................................................................4-33
4.7.4 Carryover ...............................................................................................4-34
4.7.5 LIS Setup ...............................................................................................4-35
4.8 Maintenance .......................................................................................................4-36
4.8.1 Database................................................................................................4-36
4.8.2 Log .........................................................................................................4-37
4.8.3 Maintenance ..........................................................................................4-38
4.8.4 Shutdown ...............................................................................................4-39
5Maintenance ......................................................................................... 5-1
5.1 Daily Maintenance ................................................................................................5-1
5.2 Weekly Maintenance ............................................................................................5-2
5.3 Irregular Maintenance...........................................................................................5-2
5.3.1 Cleaning Flow Cell................................................................................... 5-2
5.3.2 Adjusting the Photoelectric Gain ............................................................. 5-3
5.3.3 Calibrating the Peristaltic Pump...............................................................5-3
5.3.4 Replacing the tubing ................................................................................5-3
5.3.5 Replacing Aspiration Tubing ....................................................................5-7
5.3.6 Replacing Lamp.......................................................................................5-8
6Calculating Calibration Parameters and QC Rule ............................. 6-1
6.1 Calculating Linear Calibration Parameters ........................................................... 6-1
6.2 Calculating Nonlinear Calibration Parameters...................................................... 6-2
6.3 Calculating Concentration.....................................................................................6-4
6.3.1 Calculating Concentration of Linearly Calibrated Sample/control ...........6-4
6.3.2 Calculating Concentration of Nonlinearly Calibrated Sample/control......6-5
6.4 QC Rule ................................................................................................................6-6
6.4.1 Westgard Multi-rule..................................................................................6-6
Appendix A Specifications........................................................................A-1
Appendix B Error Messages .....................................................................B-1