Mindray BS-200 User manual

BS-200
Chemistry Analyzer
Operation Manual

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© 2006 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operation Manual, the issued Date is 2006-03 (Version: 1.2).
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, adaption 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 and local requirements;
 the product is used in accordance with the instructions for use.
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 injury of human
health.

ii
NOTE:
This equipment is to be operated only by medical professionals trained
and authorized by Mindray or Mindray-authorized distributors.
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 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 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
Manufacture: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan, Shenzhen, P.R.China, 518057
Phone: [phone] 26582888
Fax: [phone] 26582501

1
Preface
Before using the BS-200 Chemistry Analyzer, please read this operation manual
thoroughly for relevant operation instructions.
Who Should Read This Manual
This manual is written for clinical laboratory professionals to
 perform daily operating tasks;
 perform system maintenance and troubleshooting;
 learn about the BS-200 hardware and software.
WARNING:
The BS-200 Chemistry Analyzer is to be operated only by medical
professionals trained and authorized by Mindray or Mindray-authorized
distributors.
What Can You Find in This Manual
This operation manual covers principles, operations, daily maintenance and
troubleshooting of the system. Please operate and service the system strictly as
instructed by this manual.
Conventions Used in This Manual
This manual uses certain typographical conventions to clarify meanings in the text.
Bold font indicates a chapter title, such as 4 Maintenance
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.

Preface
2
When you see … Then …
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 with the text to clarify
the meaning of the text. The chart below explains the symbols on the labels.
Serial Number
Date of Manufacture
Manufacturer
The device is fully in conformance with the Council Directive
Concerning In Vitro Diagnostic Medical Devices 98/79/EC.
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
Warning: risk of electric shock
Warning: risk of burn
～Alternating current (AC)
ON (MAIN POWER)
OFF (MAIN POWER)

Preface
3
ON (Power)
OFF (Power)
Graphics
All graphics, including screens and printout, are for illustration purpose only and
must not be used for any other purposes.
EC Representative
Name: Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestrasse 80 D-20537 Hamburg Germany
Phone: [phone]
Fax: [phone]

Preface
4
Safety Precautions
Observe the following safety precautions when using the BS-200 Chemistry Analyzer.
Ignoring any of these safety precautions may lead to personal injury or equipment
damage.
WARNING:
If the system is used in a manner not specified by Mindray, the
protection provided by the system may be impaired.
Preventing Electric Shock
Please observe the following instructions to prevent electric shock.
WARNING:
When the MAIN POWER is on, users must not open the rear cover or
side cover.
Liquid ingression may lead to electric shock or equipment damage. In
case of liquid ingression, shut off the power supply and contact
Mindray Service Department or your local distributor.
Preventing Personal Injury Caused by Moving Parts
Please observe the following instructions to prevent personal injury caused by
moving parts.
WARNING:
Do not touch such moving parts as probe and mixing bar, when the
system is in operation.
Do not put your finger or hand into any open part when the system is
in operation.
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 30 minutes for the lamp to cool down
before touching it. Do not touch the lamp before it cools down, or you
may get burned.

Preface
5
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 procedure and consult a doctor.
Certain reagents are strongly acid or alkaline. Exercise caution when
using the reagents. In case your skin or clothes contact the reagents,
wash them off with soap and clean water. In case the reagents spill
into your eyes, rinse them with much water and consult an oculist.
Treating Waste
Please observe the following instructions to prevent environmental pollution and
personal injury caused by waste.
BIOHAZARD:
Dispose of the waste in accordance with your local or national
guidelines for biohazard waste disposal and consult the manufacturer
or distributor of the reagents for details.
Preventing Fire or Explosion
Please observe the following instructions to prevent fire and explosion.
WARNING:
Do not use flammable substance around the system.

Preface
6
Precautions on Use
To use the BS-200 Chemistry Analyzer safely and efficiently, please pay attention to
the following operation notes.
Intended Use
WARNING:
The BS-200 Chemistry Analyzer is a chemistry system that is designed
for the in vitro quantitative determination of clinical chemistries in
serum, plasma, urine or 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 BS-200 Chemistry Analyzer is to be operated only by medical
professionals trained and authorized by Mindray or Mindray-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 Mindray 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. 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.
Do not use other medical instruments around the system that may
generate electromagnetic noise to interfere with their operations.

Preface
7
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 analyzer is in proper state.
Be sure to run the QC program every time you use the system,
otherwise the result may be unreliable.
Do not open the cover of the sample/reagent disk when the system is
in operation.
The RS-232 port on the analyzing unit is to be used for connection with
the operation unit only. Do not use it for other connections. Only use
the supplied cable for the connection.
The operation unit is a personal computer with the control software
installed. Installing other software or hardware on this computer may
interfere with the system operation. Do not run other software when the
system is working.
Do not use this computer for other purposes. Inappropriate use of it will
probably introduce computer virus, which may spread into the system
through floppy disks, software or network.
Do not touch the display, mouse or keyboard with wet hands or hands
with chemicals.
Don’t place the MAIN POWER to ON again within 10 seconds since
placing it to OFF; otherwise the system may enter the protection
status. If it does so, place the MAIN POWER to OFF and place it to ON
again.
Maintaining the System
CAUTION:
Maintain the system strictly as instructed by this manual. Inappropriate
maintenance may lead to unreliable results or equipment damage or
personal injury.
To wipe off dust from the system surface, use a soft, clean and wet (not
too wet) cloth, soaked with soap water if necessary, to clean the
surface. Do not use such organic solvents as ethanol for cleaning. After
cleaning, wipe the surface dry with dry cloth.
Switch off all the powers and disconnect the power plug 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 photometer, probe, mixing bar and
syringe plunger assembly must be followed by a calibration.

Preface
8
Samples
CAUTION:
Use serum samples that are completely separated from blood clots or
urine samples that are free from suspended matter. If fibrin exists in the
serum samples or suspended matter exists in the urine samples, the
probe may be blocked.
Medicines, anticoagulants or preservative in the samples may lead to
unreliable results.
Hemolysis, jaundice or chylomicron in the samples may lead to
unreliable test results, so sample blanks are 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.
Not all the tests the reagents claim capable of analyzing can be
analyzed on the system. Consult the reagent suppliers for details.
Certain samples need to be processed before being analyzed by the
system. Consult the reagent suppliers for details.
The system has a specific requirement on the sample volume. Refer to
this manual for proper sample volume.
Load the sample to proper tube position on the sample disk before the
analysis begins; otherwise you will not obtain correct results.
Reagents, Calibrators and Controls
CAUTION:
Use proper reagents, calibrators and controls in the system.
Select appropriate reagents according to performance characteristics
of the system. Consult the reagent suppliers, Mindray or
Mindray-authorized distributor for details, if you are not sure about your
reagent choice.
Store and use the reagents, calibrators and controls strictly as
instructed by the suppliers. Otherwise, you may not obtain reliable
results or best performance of the system.
Perform calibration after changing the reagents. Otherwise, you may
not obtain reliable results.
Contamination caused by carryover among reagents may lead to
unreliable test results. Consult the reagent suppliers for details.

Preface
9
Setting up the System
CAUTION:
To define such parameters as sample volume, reagent volume and
wavelength, follow the instructions in this manual and the instructions
of reagents.
Backing up Data
NOTE:
The system automatically stores the data to the built-in hard disk.
However, data loss is still possible due to mis-deletion or physical
damage of the hard disk. Mindray recommends you to regularly back
up the data to such medium as CDs.
Computer and Printer
NOTE:
Refer to their operation manuals for details.
External Equipment
WARNING:
External equipment connected to the system, such as PC and printer,
shall be consistent with IEC 60950 or EN 60950.

I
Contents
Preface.......................................................................................................................................... 1
Who Should Read This Manual ............................................................................................. 1
What Can You Find in This Manual........................................................................................ 1
Conventions Used in This Manual ......................................................................................... 1
Safety Precautions ................................................................................................................. 4
Precautions on Use................................................................................................................ 6
1System Description .......................................................................................................... 1-1
1.1 Hardware Introduction ......................................................................................... 1-1
1.1.1 Analyzing Unit ...................................................................................... 1-1
1.1.2 Operation Unit ...................................................................................... 1-6
1.1.3 Output Unit ........................................................................................... 1-6
1.2 Software Introduction........................................................................................... 1-6
1.2.1 Software Interface ................................................................................ 1-6
1.2.2 Main Interface Components ................................................................. 1-8
2Installation ......................................................................................................................... 2-1
2.1 Unpacking............................................................................................................ 2-1
2.2 Installation Requirements .................................................................................... 2-1
2.2.1 Installation Environment Requirements................................................ 2-1
2.2.2 Power Requirements............................................................................ 2-2
2.2.3 Temperature and Humidity Requirements............................................ 2-2
2.2.4 Water Supply and Drain Requirements................................................ 2-3
2.2.5 Space and Accessibility Requirements................................................. 2-3
2.3 Connecting Deionized Water Tank ...................................................................... 2-4
2.4 Connecting Waste Tank....................................................................................... 2-5
2.5 Installing/Removing Sample/Reagent Disk .........................................................2-5
2.6 Installing/Removing Sample Tubes ..................................................................... 2-6
2.7 Installing/Removing Reagent Bottles................................................................... 2-7
2.8 Installing/Removing Cuvettes .............................................................................. 2-7
3Basic Operations .............................................................................................................. 3-1
3.1 Daily Procedure ................................................................................................... 3-1
3.2 Preparing for Analysis.......................................................................................... 3-2
3.2.1 Checking before Startup....................................................................... 3-2
3.2.2 Power-on .............................................................................................. 3-3
3.2.3 Starting the Control Software ............................................................... 3-3
3.2.4 Setting Up the Analyzer........................................................................ 3-4
3.2.5 Preparing Reagents..............................................................................3-5
3.3 Starting Analysis .................................................................................................. 3-5
3.3.1 Reagent Blank ...................................................................................... 3-5
3.3.2 Calibration ............................................................................................ 3-5
3.3.3 QC ........................................................................................................ 3-6
3.3.4 Samples................................................................................................ 3-6
3.4 Processing Results .............................................................................................. 3-7
3.4.1 Editing Results of Samples ..................................................................3-7
3.4.2 Printing Results of Samples ................................................................. 3-7
3.5 Finishing Analysis ................................................................................................ 3-7
3.5.1 Exiting the Control Software................................................................. 3-7
3.5.2 Shutdown.............................................................................................. 3-7
3.5.3 Operations after Shutdown................................................................... 3-8

Contents
II
4Advanced Operations....................................................................................................... 4-1
4.1 Sample Request .................................................................................................. 4-1
4.1.1 Sample Information .............................................................................. 4-3
4.1.2 Delete a Sample ................................................................................... 4-5
4.1.3 Change Position ................................................................................... 4-6
4.1.4 Requesting Samples or Modifying Information .................................... 4-7
4.2 QC Request ......................................................................................................... 4-7
4.3 Start ...................................................................................................................4-10
4.4 Probe Stop......................................................................................................... 4-11
4.5 Stop....................................................................................................................4-12
4.6 Current Results..................................................................................................4-13
4.7 Replace.............................................................................................................. 4-15
4.8 Re-log ................................................................................................................4-17
4.9 Exit..................................................................................................................... 4-17
4.10 History................................................................................................................ 4-18
4.10.1 Conditions........................................................................................... 4-20
4.10.2 Add Off-system Test Results ..............................................................4-22
4.10.3 Compensate Results ..........................................................................4-23
4.10.4 Edit Results ........................................................................................4-25
4.10.5 Reaction Curve...................................................................................4-27
4.10.6 Delete Results ....................................................................................4-28
4.10.7 Print Results .......................................................................................4-29
4.10.8 Result Trend Curve ............................................................................ 4-30
4.11 Reagent ............................................................................................................. 4-32
4.12 Calibration.......................................................................................................... 4-33
4.12.1 Calibration Request............................................................................ 4-33
4.12.2 Results................................................................................................ 4-37
4.12.3 Calibrator ............................................................................................ 4-45
4.13 QC .....................................................................................................................4-47
4.13.1 Real-time QC......................................................................................4-48
4.13.2 Daily QC ............................................................................................. 4-49
4.13.3 Day to Day QC ...................................................................................4-52
4.13.4 Control ................................................................................................4-55
4.14 Status................................................................................................................. 4-57
4.14.1 Sample Disk .......................................................................................4-58
4.14.2 Reagent Disk...................................................................................... 4-61
4.14.3 Reaction Disk ..................................................................................... 4-65
4.15 Statistics............................................................................................................. 4-65
4.15.1 Worklist............................................................................................... 4-66
4.15.2 Results................................................................................................ 4-67
4.15.3 Workload ............................................................................................4-70
4.15.4 Charges .............................................................................................. 4-72
4.16 Setup .................................................................................................................4-74
4.16.1 Test ..................................................................................................... 4-75
4.16.2 Profile .................................................................................................4-85
4.16.3 Calculation..........................................................................................4-87
4.16.4 Off-system Test...................................................................................4-89
4.16.5 Carryover............................................................................................4-90
4.16.6 System................................................................................................ 4-91
4.16.7 Hospital............................................................................................... 4-96
4.16.8 User .................................................................................................... 4-98
4.16.9 Print ..................................................................................................4-101
4.17 Maintenance ....................................................................................................4-105
4.17.1 Daily Maintenance............................................................................4-105
4.17.2 Log.................................................................................................... 4-107
4.17.3 Import/Export.................................................................................... 4-109
4.17.4 Commission...................................................................................... 4-111
5Maintenance ...................................................................................................................... 5-1

Contents
III
5.1 Preparation .......................................................................................................... 5-1
5.2 Daily Maintenance ............................................................................................... 5-2
5.2.1 Checking Remaining Deionized Water................................................. 5-2
5.2.2 Emptying Waste Tank........................................................................... 5-3
5.2.3 Checking Connection of Deionized Water............................................ 5-3
5.2.4 Checking Connection of Wastewater ................................................... 5-4
5.2.5 Checking Syringe ................................................................................. 5-5
5.2.6 Checking Probe .................................................................................... 5-6
5.2.7 Checking Mixing Bar ............................................................................ 5-7
5.3 Weekly Maintenance ........................................................................................... 5-7
5.3.1 Cleaning Probe..................................................................................... 5-7
5.3.2 Cleaning Mixing Bar ............................................................................. 5-8
5.3.3 Washing Deionized Water Tank ........................................................... 5-9
5.3.4 Washing Waste Tank ..........................................................................5-10
5.3.5 Cleaning Sample/Reagent Compartment .......................................... 5-11
5.3.6 Cleaning Panel of Analyzing Unit ....................................................... 5-11
5.4 Monthly Maintenance ........................................................................................5-12
5.4.1 Cleaning Wash Well of Probe............................................................. 5-12
5.4.2 Cleaning Wash Well of Mixing Bar ..................................................... 5-12
5.5 Maintenance Every Six Months .........................................................................5-12
5.6 Irregular Maintenance........................................................................................ 5-13
5.6.1 Unclogging Probe...............................................................................5-13
5.6.2 Replacing Probe................................................................................. 5-16
5.6.3 Replacing Mixing Bar .........................................................................5-17
5.6.4 Replacing Plunger Assembly of Syringe ............................................5-18
5.6.5 Replacing Lamp ................................................................................. 5-20
5.7 Maintenance Log ...............................................................................................5-22
6Troubleshooting................................................................................................................6-1
7Calculation Methods......................................................................................................... 7-1
7.1 Analytical Methods .............................................................................................. 7-1
7.1.1 Endpoint ............................................................................................... 7-1
7.1.2 Fixed-Time............................................................................................ 7-2
7.1.3 Kinetic................................................................................................... 7-3
7.2 Calculation Process ............................................................................................. 7-5
7.2.1 Absorbance .......................................................................................... 7-5
7.2.2 Response ............................................................................................. 7-6
7.2.3 Calibration Parameters......................................................................... 7-9
7.2.4 Concentration ..................................................................................... 7-12
7.2.5 QC rules ............................................................................................. 7-14
Appendix A Specifications............................................................................................ A-1
A.1 Technical Specifications.......................................................................................A-1
A.2 Power Requirements ...........................................................................................A-1
A.3 Environmental Requirements ..............................................................................A-2
A.3.1 Storage Requirements..........................................................................A-2
A.3.2 Operation Requirements ......................................................................A-2
A.4 Dimension and Weight ........................................................................................A-2
A.5 Other Specifications.............................................................................................A-2
A.6 Input/Output Devices ...........................................................................................A-2
A.7 Interface...............................................................................................................A-3
Appendix B Supplies ..................................................................................................... B-1
Appendix C Index........................................................................................................... C-1

1-1
1 System Description
This chapter includes the following two sections:
 Hardware Introduction
 Software Introduction
The BS-200 Chemistry Analyzer is a chemistry system that is designed for the in
vitro quantitative determination of clinical chemistries in serum, plasma, urine or CSF
samples.
NOTE:
Not all the tests the reagents claim capable of analyzing can be
analyzed on the system. Consult the reagent suppliers for details.
1.1 Hardware Introduction
The system consists of the following three units – the analyzing unit, operation unit
and output unit.
1.1.1 Analyzing Unit
The analyzing unit consists of the following major parts:
 Sample/Reagent Disk
 Dispenser
 Mixer
 Reaction Disk
 Photometric System

System Description
1-2
Figure 1-1 Analyzing unit
MAIN POWER
Power
Cover
Sample/Reagent Disk
Reaction Disk
Dispenser
Mixer
Lower Cabinet (optional)
Syringe
Upper Cabinet
1.1.1.1 Sample/Reagent Disk
The sample/reagent disk holds sample tubes and reagent bottles.
Figure 1-2 Sample/Reagent disk
Sample/reagent Disk
The disk is composed of two circles – sample disk on the outer circle and reagent
disk on the inner circle.