Mindray BS-120, BS-130, BS-190, BS-180 Service Manual
BS-120/BS-130/BS-180/BS-190
Chemistry Analyzer
Service Manual
i
© 2007-2010 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights
Reserved.
For this Service Manual, the issued Date is 2010-04 (Version: 4.0).
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this manual.
This manual may refer to information protected by copyrights or patents and does not
convey any license under the patent rights of Mindray, nor the rights of others.
Mindray does not assume any liability arising out of any infringements of patents or
other rights of third parties.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the
written permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rent, 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.
Upon request, Mindray may provide, with compensation, necessary circuit diagrams,
calibration illustration list and other information to help qualified technician to maintain
and repair some parts, which Mindray may define as user serviceable.
ii
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
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.
NOTE:
This equipment is to be operated only by medical professionals trained
and authorized by Mindray or Mindray-authorized distributors.
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:
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.
Freight policy: The customer is responsible for freight charges when this product
is shipped to Mindray for service (this includes customs charges).
Return address: Please send the part(s) or equipment to the address offered by
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, ShenZhen 518057, P.R.China,
Tel:
Fax:
+86 755 26582479 26582888
+86 755 26582934 26582500
iv
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 BS-120/BS-130/BS-180/BS-190. Please service the
system strictly as instructed by this manual.
Conventions Used in This Manual
Foreword
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
In this manual, the signal words
and NOTE are used regarding safety and other important instructions. The signal
words and their meanings are defined as follows. Please understand their meanings
clearly before reading this manual.
When you see… Then…
WARNING
BIOHAZARD
CAUTION
Read the statement following the symbol. The
statement is alerting you to an operating hazard that
can cause personal injury.
Read the statement following the symbol. The
statement is alerting you to a potentially
biohazardous condition.
Read the statement following the symbol. The
statement is alerting you to a possibility of system
damage or unreliable results.
BIOHAZARD, WARNING, CAUTION
NOTE
Read the statement following the symbol. The
statement is alerting you to information that requires
your attention.
1
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
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
In Vitro diagnostic equipment
Biohazard warning: Risk of potentially biohazardous infection
Warning: Risk of personal injury or equipment damage
Protective ground terminal
Time limit in use for environmental protection (20 years)
ON (Main Power)
OFF (Main Power)
ON (Power)
OFF (Power)
Serial communication port
Graphics
All graphics, including screens and printout, are for illustration purposes only and
must not be used for any other purpose.
2
EC Representative
Name: Shanghai International Holding Corp. GmbH(Europe)
Address:
Eiffestrasse 80 D-20537 Hamburg Germany
Tel:
Fax:
+49 40 2513174
+49 40 255726
3
Safety Precautions
Observe the following safety precautions when using the 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.
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.
Preventing Personal Injury Caused by Moving Parts
Please observe the following instructions to prevent personal injury caused by
moving parts.
WARNING
Do not touch the moving parts when system is in operation. The
moving parts include sample probe, mixing bar, sample/reagent disk
and reaction disk.
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 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.
4
Preventing Infection
Please observe the following instructions to protect against the biohazardous
infection.
BIOHAZARD
Inappropriately handling samples, controls and calibrators 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, control or calibrator, follow
standard laboratory safety procedure and consult a doctor.
Handling Reagents and Wash Solution
WARNING
Some reagents and wash solution may be corrosive to human skins.
Plaase handle the reagents and concentrated wash solution carefully
and avoid direct contact.In case your skin or clothes contact the
reagents or wash solution, wash them off with water. In case the
reagents or wash solution spill into your eyes, rinse them with much
water and consult an oculist.
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.
5
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.
6
Precautions on Use
To use the BS-120/BS-130/BS-180/BS-190 Chemistry Analyzer safely and
efficiently, please pay much attention to the following operation notes.
Intended Use
WARNING
The BS-120/BS-130/BS-180/BS-190 is a fully-automated and
computer-controlled chemistry 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 BS-120/BS-130/BS-180/BS-190 is to be operated only by
clinical professionals, doctors or laboratory experimenters trained 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.
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.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.
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 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 open the covers of the sample/reagent disk cover when the
system is in operation.
Do not open the reaction disk cover when 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
BS-120/BS-130/BS-180/BS-190 operating 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.
Computer virus may destroy the operating software or test data. Do
not use this computer for other purposes or connect it to the Internet.
Do not touch the display, mouse or keyboard with wet hands or
hands with chemicals.
Do not place the Main Power to ON again within 10 seconds since
placing it to OFF; otherwise the system may enter protection status.
If it does so, switch off the Main Power and switch it on again.
Service and Maintenance
CAUTION
Maintain the system strictly as instructed by this manual.
Inappropriate maintenance may lead to unreliable results, or even
equipment damage and personal injury.
Dust may accumulate on the system surface when the system is
exposed to the outside for a long time.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, photometer, sample
probe, mixer and syringe plunger assembly must be followed by a
calibration.
8
Setting up the System
CAUTION
To define such parameters as sample volume, reagent volume and
wavelength, follow the instructions in this manual and the package
insert of the reagents.
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 samples may
lead to unreliable results.
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
BS-120/BS-130/BS-180/BS-190 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.
The system has specific requirements on the sample volume. Refer
to this manual for details.
Load the sample to correct position on the sample disk before the
analysis begins; otherwise you will not obtain correct results.
9
10
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, Mindray or
Mindray-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.
Backing up Data
NOTE
The system can automatically store data to the built-in hard disk of
the PC. 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 portable storage device.
Computer and Printer
NOTE
Refer to the operation manuals of computer and printer for details.
External Equipment
WARNING
External equipment connected to the system, such as PC and printer,
shall be consistent with IEC 60950/EN 60950/ GB4943, EN55022
(Class B) /GB 9254 (Class B) and EN55024/ GB-T 17618.
Contents
Intellectual Property Statement ........................................................................................... i
Responsibility on the Manufacturer Party............................................................................ i
Warranty..............................................................................................................................ii
Return Policy .......................................................................................................................ii
Foreword .......................................................................................................................................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 ............................................................................................................7
Contents.........................................................................................................................................I
1
System Description..........................................................................................................1-1
1.1 Overview...............................................................................................................1-1
1.2 System Components ............................................................................................1-1
1.3 Functions ..............................................................................................................1-3
2
System Performace and Workflow ..................................................................................2-1
2.1 Technical Specifications........................................................................................2-1
2.1.1 System Specifications..............................................................................2-1
2.1.2 Specifications for Sample System...........................................................2-2
2.1.3 Specifications for Reagent System..........................................................2-3
2.1.4 Specifications of Reaction System ..........................................................2-4
2.1.5 Specifications of Operation......................................................................2-5
2.1.6 Installation Requirements ........................................................................2-5
2.1.7 Optional Modules.....................................................................................2-6
2.2 Workflow (BS-120/BS-130)...................................................................................2-6
2.2.1 Overview..................................................................................................2-6
2.2.2 Timing......................................................................................................2-6
2.2.3 Test Workflow...........................................................................................2-9
2.2.4 Measuring Points................................................................................... 2-11
2.3 Workflow (BS-180/BS-190).................................................................................2-11
2.3.1 Overview................................................................................................2-11
2.3.2 Timing......................................................................................................2-8
2.3.3 Test Workflow...........................................................................................2-9
3
Installation........................................................................................................................3-1
3.1 Environmental Requirements ...............................................................................3-1
3.2 Installation Requirements.....................................................................................3-2
3.2.1 Space and Accessibility Requirements....................................................3-2
3.2.2 Power Requirements ...............................................................................3-2
3.2.3 Water Supply and Drainage Requirements.............................................3-3
3.3 Installation Procedures.........................................................................................3-3
3.3.1 Unpacking................................................................................................3-3
3.3.2 Installation................................................................................................3-5
3.3.3 Operating Software Installation................................................................3-7
3.3.4 Run Operating Software ..........................................................................3-9
3.3.5 Setting up the System............................................................................3-10
3.3.6 Test ........................................................................................................3-14
Contents I
3.3.7 Exit the System......................................................................................3-15
4
Units Description .............................................................................................................4-1
4.1 Enclosure and Panel Unit.....................................................................................4-1
4.1.1 Components.............................................................................................4-1
4.1.2 Dismounting/Mounting of Enclosure Unit ................................................4-2
4.2 Probe Unit.............................................................................................................4-5
4.2.1 Function Introduction ...............................................................................4-5
4.2.2 Components of Probe Unit ......................................................................4-5
4.2.3 Dismounting/mounting Sample Probe Unit..............................................4-6
4.3 Sample/Reagent Disk Unit .................................................................................4-10
4.3.1 Function Introduction .............................................................................4-10
4.3.2 Components of Sample/Reagent Disk Unit...........................................4-10
4.3.3 Dismounting Sample/Reagent Disk Unit ............................................... 4-11
4.4 Reaction Disk Unit ..............................................................................................4-17
4.4.1 Function Introduction .............................................................................4-17
4.4.2 Components of Reaction Disk Unit........................................................4-18
4.4.3 Dismounting Reaction Disk Unit ............................................................4-19
4.5 Mixing Unit..........................................................................................................4-22
4.5.1 Function Introduction .............................................................................4-22
4.5.2 Components of Mixing Unit....................................................................4-22
4.5.3 Dismounting Mixing Unit........................................................................4-23
4.6 Photometric Unit .................................................................................................4-26
4.6.1 Introduction............................................................................................4-26
4.6.2 Components of Photometric Unit...........................................................4-26
4.6.3 Dismounting and Mounting Photometric Unit........................................4-30
4.6.4 Adjustment of Photometer .....................................................................4-32
4.7 Power Supply Unit ..............................................................................................4-38
4.7.1 Function and Components.....................................................................4-38
4.7.2 Dismounting Power Supply Unit............................................................4-38
4.8 ISE Unit (Optional)..............................................................................................4-39
4.8.1 Introduction............................................................................................4-39
4.8.2 Components of ISE Unit ........................................................................4-39
4.8.3 Installling and Removing ISE Unit .........................................................4-40
5
Fluid System....................................................................................................................5-1
5.1 Main Functions .....................................................................................................5-1
5.2 Functional Structure..............................................................................................5-1
5.3 Fluid System Chart ...............................................................................................5-2
5.4 Major Components and Their Functions ..............................................................5-3
5.5 Connectors ...........................................................................................................5-4
5.6 Tubing...................................................................................................................5-5
5.7 Fluid System Connections and Layout.................................................................5-6
5.8 External DI Water Tank and Waste Tank ..............................................................5-8
5.9 Key Components ..................................................................................................5-9
5.9.1 Solenoid Valve.............................................................................................5-9
5.9.2 Check Valve.................................................................................................5-9
5.9.3 Liquid Level Float ......................................................................................5-10
5.9.4 Syringe Assembly......................................................................................5-10
5.9.5 Diaphragm Pump.......................................................................................5-11
5.9.6 Probe .........................................................................................................5-11
5.9.7 Filter.......................................................................................................5-12
6
Hardware System............................................................................................................6-1
6.1 Overview...............................................................................................................6-1
II
Contents
6.2 Safety Precautions................................................................................................6-1
6.3 Circuit boards........................................................................................................6-2
6.4 Layout of the Boards.............................................................................................6-4
6.5 Detaching and Assembling Circuit Boards ...........................................................6-4
6.6 Function of the Boards .........................................................................................6-5
6.6.1 Control Framework ..................................................................................6-5
6.6.2 Main Board ..............................................................................................6-5
6.6.3 Drive Board..............................................................................................6-6
6.6.4 Pre-amp Board ........................................................................................6-7
6.6.5 AD Conversion Board..............................................................................6-7
6.6.6 Reagent Refrigeration Board...................................................................6-8
6.6.7 Level Detection Board .............................................................................6-8
6.6.8 Reaction Disk Temperature Sampling Board...........................................6-9
6.6.9 Three Probes Connection Board.............................................................6-9
6.6.10 ISE Power Board ...................................................................................6-9
6.6.11 Heater Voltage Selecting Board.............................................................6-9
6.7 On Board LED Indication......................................................................................6-9
6.8 Power Supply Unit ..............................................................................................6-11
6.8.1 Features of Power Supply Unit..............................................................6-12
6.8.2 Protective Function of Power Supply Unit.............................................6-13
6.8.3 Block Diagram .......................................................................................6-13
6.9 Connection Diagram...........................................................................................6-14
7
Service and Maintenance................................................................................................7-1
7.1 Preparation ...........................................................................................................7-1
7.1.1 Tools.........................................................................................................7-2
7.1.2 Wash Solution..........................................................................................7-2
7.1.3 Others......................................................................................................7-2
7.2 Daily Maintenance ................................................................................................7-3
7.2.1 Checking Remaining Deionized Water....................................................7-3
7.2.2 Emptying Waste Tank ..............................................................................7-3
7.2.3 Checking Connection of Deionized Water...............................................7-4
7.2.4 Checking Connection of Waste Water.....................................................7-4
7.2.5 Checking Syringe.....................................................................................7-4
7.2.6 Checking/Cleaning Sample Probe...........................................................7-5
7.2.7 Checking/Cleaning Mixing Bar ................................................................7-6
7.2.8 Checking Printer/Printing Paper ..............................................................7-6
7.2.9 Checking ISE Unit (Optional)...................................................................7-6
7.3 Weekly Maintenance ............................................................................................7-8
7.3.1 Cleaning Sample Probe...........................................................................7-8
7.3.2 Cleaning Mixing Bar.................................................................................7-9
7.3.3 Cleaning Sample/Reagent Compartment..............................................7-10
7.3.4 Cleaning Panel of Analyzing Unit ..........................................................7-11
7.3.5 Washing Deionized Water Tank.............................................................7-11
7.3.6 Washing Waste Tank .............................................................................7-12
7.4 Monthly Maintenance..........................................................................................7-13
7.4.1 Cleaning Wash pool of Probe................................................................7-13
7.4.2 Cleaning Wash pool of Mixing Bar.........................................................7-14
7.4.3 Cleaning Sample/Reagent Rotor...........................................................7-15
7.5 Three-month Maintenance .................................................................................7-15
7.5.1 Washing Dust Screen............................................................................7-15
7.5.2 Replacing Filter Assemby......................................................................7-17
7.6 Irregular Maintenance.........................................................................................7-18
7.6.1 Checking photoelectric system performance.........................................7-18
Contents III
7.6.2 Replacing the lamp................................................................................7-18
7.6.3 Replacing the Filter................................................................................7-21
7.6.4 Unclogging Sample Probe.....................................................................7-23
7.6.5 Replacing Probe ....................................................................................7-29
7.6.6 Replacing Mixing Bar.............................................................................7-30
7.6.7 Replacing Plunger Assembly of Syringe................................................7-32
7.6.8 Removing Air Bubbles ...........................................................................7-35
7.6.9 Replacing Dust Screen..........................................................................7-36
7.6.10 Replacing Waste Tubing......................................................................7-36
7.7 Maintaining ISE Module (Optional).....................................................................7-36
7.7.1 Replace Reagent Pack..........................................................................7-36
7.7.2 Replacing Electrodes.............................................................................7-37
7.7.3 Replacing Tubing...................................................................................7-38
7.7.4 Storage of ISE Module (Optional)..........................................................7-38
8
Test and Maintenance Software......................................................................................8-1
8.1 Basic Operations ..................................................................................................8-1
8.1.1 Installation................................................................................................8-1
8.1.2 Overview..................................................................................................8-1
8.2 Operating Commands...........................................................................................8-3
8.2.1 Main Unit..................................................................................................8-4
8.2.2 Mixing Unit...............................................................................................8-4
8.2.3 Reagent Unit............................................................................................8-5
8.2.4 Sample Unit .............................................................................................8-6
8.2.5 Reaction Unit ...........................................................................................8-7
8.2.6 ISE Module ..............................................................................................8-8
8.2.7 Temperature Unit...................................................................................8-10
8.3 Parameter...........................................................................................................8-12
8.3.1 The Precondition for Parameter Configuration......................................8-13
8.3.2 Detailed Operations...............................................................................8-15
8.4 Temperature........................................................................................................8-17
8.4.1 Functions ...............................................................................................8-17
8.4.2 Operation Details...................................................................................8-17
8.5 Photoelectric.......................................................................................................8-18
8.5.1 Filter Offset ............................................................................................8-18
8.5.2 Photoelectric Gain .................................................................................8-19
8.5.3 Light Source Background ......................................................................8-20
8.5.4 Dark Current Test...................................................................................8-21
8.5.5 Other Functions of the Photoelectric Test..............................................8-22
8.6 Macro Instructions ..............................................................................................8-22
8.6.1 Function.................................................................................................8-22
8.6.2 Detailed Operations...............................................................................8-22
9
Troubleshooting...............................................................................................................9-1
9.1 Error Message Classification................................................................................9-1
9.2 Classification of Error Messages..........................................................................9-2
9.3 Operation Unit Error..............................................................................................9-5
9.4 Analyzing Unit Error............................................................................................9-12
9.4.1 Main Unit................................................................................................9-12
9.4.2 Sample/Reagent Unit.............................................................................9-14
9.4.3 Reaction Disk Unit .................................................................................9-19
9.4.4 Temperature Unit...................................................................................9-23
9.4.5 Mixing Unit.............................................................................................9-25
9.4.6 ISE Unit..................................................................................................9-28
9.4.7 Other Units Failures...............................................................................9-49
IV
Contents
10 Caculation Methods.......................................................................................................10-1
10.1
Reaction Type.................................................................................................10-1
10.1.1 Endpoint...............................................................................................10-1
10.1.2 Fixed-Time...........................................................................................10-2
10.1.3 Kinetic..................................................................................................10-3
10.2
Calculation Process ........................................................................................10-4
10.2.1 Calculating Absorbance.......................................................................10-5
10.2.2 Calculating Response..........................................................................10-6
10.2.3 Calculating Calibration Parameters.....................................................10-8
10.2.4 Calculating Concentration.................................................................. 10-11
10.2.5 QC Rule.............................................................................................10-12
Contents V
1
System Description
1.1 Overview
The BS-120/BS-130/BS-180/BS-190 is a fully-automated and
computer-controlled chemistry analyzer designed for in vitro quantitative
determination of clinical chemistries in serum, plasma, urine and CSF
(Cerebrospinal fluid) samples. BS-120/BS-130/BS-180/BS-190 Chemistry
Analyzer consists of the analyzing unit (analyzer), operation unit (personal
computer), output unit (printer) and consumables.
1.2 System Components
BS-120/BS-130/BS-180/BS-190 Chemistry Analyzer realizes the ”two-disk +
one-probe + one-mixing bar” scheme, which means one reaction disk, one
sample/reagent disk, one sample probe and one mixing bar. Reaction disk is
where cuvettes are placed; sample/reagent disk is where sample and reagent
containers are placed; sample probe is used for dispensing R1/R2/S; mixing
bar is used for mixing after S or R2 has been added. The photometric system
adopts filter wheel photometer. The cuvettes are replaced manually after the
tests are finished.
1 System Description 1-1
Figure1-1 Layout of the System Panel
Figure 1-2 System Structure-Front View
1 System Description 1-2
Figure 1-3 System Structure-left Panel View
1.3 Functions
The general working procedure of the BS-120/BS-130/BS-180/BS-190 is as
follows:
1. All mechanical units are initialized.
2. The sample/reagent disk rotates to R1 aspirating position, and the probe
aspirates reagent from a bottle on the sample/reagent disk.
3. The reaction disk carries the cuvettes to the sample/reagent dispensing
position, and the probe dispenses reagent to a cuvette.
4. R1 is incubated in reaction cuvette for several periods.
5. The sample/reagent disk rotates to sample aspirating position, and the
reaction disk carries the cuvettes to the sample/reagent dispensing
position, then the probe dispenses the sample in the reaction cuvette.
6. With sample dispensed, the reaction cuvette rotates to mixing position for
stirring.
7. In case of single-reagent tests, the reaction begins. When defined time is
over, the reaction ends.
8. In case of double-reagent tests, when sample is dispensed and sirred, the
sample/reagent disk rotates to the R2 aspirating position, and the probe
aspirates reagent from the specified bottle on the reagent disk.
9. The reaction disk carries the cuvettes to the sample/reagent dispensing
position, and the probe dispenses reagent to a cuvette.
10. With R2 dispensed, the reaction cuvette is carried to the mixing position
for stirring.
11. During the first and second rotation of each period, the reaction cuvette
receives photometric measurement.
1 System Description 1-3
12.
When a batch of analysis is finished or all the cuvettes are used up,
replace the cuvettes manually.
Table 1-1 Functions of System Units
UNIT NAME DESCRIPTION
Sample probe unit
Sample/Reagent
Disk Unit
Reaction Disk Unit
Mixing Unit
Photometric Unit
ISE Unit (optional)
Aspirates and dispenses samples and reagents for all
chemical and ISE tests.
36 positions.
Default: 1~8# sample position; 9~36# reagent position.
Able to hold 40 cuvettes. It provides an environment in
which sample reacts with reagents.
Used to stir the mixture in reaction cuvette when
sample or R2 is dispensed.
Adopts filter wheel structure and performs photometric
measurement (absorbance reading) at 8 wavelengths.
ISE (Ion Selective Electrode) module (not installed on
domestic product).
1 System Description 1-4
2
System Performace and
2.1 Technical Specifications
2.1.1 System Specifications
System
Random, multi-channel, multi-test
Sample type
Serum, urine, plasma and CSF (Cerebrospinal fluid)
Number of simultaneous measurements
Workflow
13/26 single-/double-reagent tests
Throughput
BS-120/BS-130: 100 tests/hour, or 300 tests/hour with ISE unit.
BS-180/BS-190: 220 tests/hour, or 440 tests/hour with ISE unit.
Reaction types
Endpoint, Kinetic, Fixed-time; single-/double-reagent test;
single-/double-wavelength test
Reaction time
Maximum 10 minutes for single-reagent analysis; maximum 5 minutes for
double-reagent analysis.
2 System Performance and Workflow
2-1
Reaction liquid volume
BS-120/BS-130: 180-500µl
BS-180/BS-190: 150-500µl
Reaction temperature
37℃
Test scope
Clinical chemistries, immunoassays, TDM (Treatment Drug Monitoring)
Auto dilution
Dilution ratio 4~150; dilution is done in reaction cuvette.
Operation mode
System and tests are configured via the operating software. Profiles and
calculation tests are allowed.
Calibration method
Linear (one-point, two-point and multi-point), Logit-Log 4p, Logit-Log 5p, Spline,
Exponential, Polynomial and Parabola
Programming Controls
Westgard Multi-rule, Cumulative sum check, Twin plot
Data processing
Capable of storing and outputting various data and tables/graphs, and calculating
among different tests
Dimensions
l×b×h:690 mm×570 mm×595 mm.
Weight
≤75kg
Emergent samples
Emergent samples can be inserted during test at any time.
Network connection
Able to be connected with LIS (Laboratory Information Management System)
2.1.2 Specifications for Sample System
Sample tube type
Microtube: Φ10×37mm, Φ12×37mm;
Blood collecting tube: Φ12×68.5mm, Φ12×99, Φ12.7×75, Φ12.7×100, Φ13×75,
Φ13×100;
2-2
2 System Performance and Workflow
Plastic tube: Φ12×68.5mm, Φ12×99, Φ12.7×75, Φ12.7×100, Φ13×75,
Φ13×100.
Minimum sample volume
Minimum sample volume=dead volume of the sample+total sample volume
needed for all the tests
Dead volume of the sample: Microtube ≤300, Blood collecting tube≤500ul, Plastic
tube≤500ul.
Sample position
Sample and reagent share one sample/reagent disk which is of single-circle
structure. No.1-No.8 are sample positions which can be set as routine, QC, STAT
positions.
STAT sample
Emergent samples can be inserted during test at any time and then run with high
priority.
Sample volume
3µl-45µl, with increment of 0.5µl
Sample probe
Sample and reagent share one probe, which is capable of detecting liquid level,
protecting the probe against collision in the vertical direction and tracking liquid
level.
Sample probe washing
Inside and outside of the probe are washed with carryover less than 0.1%.
Sample input mode
Enter manually
When hand-held bar code system is installed, the sample information can be
entered by using the bar code. Refer to the documents accompanying the
optional hand-held bar code reader.
2.1.3 Specifications for Reagent System
Reagent refrigeration
24 hours non-stop refrigeration, refrigeration temperature: 4-15℃
Reagent dispensing
Reagent is aspirated and dispensed precisely by syringes.
Reagent types
1 to 2 reagent types, R1 and R2
2 System Performance and Workflow
2-3
Reagent volume
30µl-450µl, with increment of 1µl
Reagent position assignment
Sample and reagent share one sample/reagent disk which is of single-circle
structure. No.9-No.36 are reagent positions and No. 35 is fixed for wash solution
and No. 36 is fixed for dilution.Other positions can be assigned for R1 or R2. If
ISE module is installed, No.34 is fixed for ISE wash solution.
Reagent input mode
Enter manually
When hand-held bar code system is installed, the reagent information can be
entered using the bar code. Refer to the documents accompanying the optional
hand-held bar code reader.
Reagent probe
Sample and reagent share one probe, which is capable of detecting liquid level,
protecting the probe against collision in the vertical direction and tracking liquid
level.
Reagent probe washing
Inside and outside of the probe are washed with carryover less than 0.1%.
2.1.4 Specifications of Reaction System
Optical path of reaction cuvette
5mm
Material of reaction cuvette
5mm×6mm×30mm, disposable reaction cuvette
Number of reaction cuvettes
40
Mixing method
One mixing bar, which starts to stir after adding a samples or R2
Photometric System
Filter wheel optical system
2-4
Wavelength
8 wavelengths：340nm、405nm、450nm、510nm、546nm、578nm、630nm、
670nm
Wavelength accuracy
±2nm
2 System Performance and Workflow
5
Light source
12V, tungsten-halogen lamp, 20W
Photometric measurement method
Photodiode
Measurement range
0～3.5A（for 10mm optical path）
2.1.5 Specifications of Operation
Display
17/15’’ LCD and CRT, resolution: 1024×768, refresh rate: 70Hz
Operating System
Windows XP, Windows Vista
Communication interface
RS-232
Printer
Ink jet printer, laser printer (black-white) and stylus printer
Input device
Keyboard, hand-held barcode scanner connected to the network (optional)
Output device
Display, printer and LIS host
Storage device
Hard disk, USB port
2.1.6 Installation Requirements
Power requirement
100V-130V, 200V-240V
Power frequency
50/60Hz (±3Hz fluctuation)
Power of analyzing unit
350VA
Water consumption
Less than 2.5L/hour
2 System Performance and Workflow
2-
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