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Automatic biochemistry analyzer BK-200 user manual

Automatic Biochemistry Analyzer


User Manual

BK-200 (SAPPHIRE)

Jinan Biobase Biotech Co., Ltd.


Automatic biochemistry analyzer BK-200 user manual

Content
Preface................................................................................................................................................. 1
Guarantee.................................................................................................................................... 2
Product manual.......................................................................................................................... 4
Transportation and storage......................................................................................................... 5
Safety Information...................................................................................................................... 7
Safety Symbols........................................................................................................................... 7
Safety Precautions...................................................................................................................... 8
Operation Precautions...............................................................................................................11
Instrument operation.................................................................................................................12
Chapter 1 Main Introduction.............................................................................................................17
1.1 System Composition...........................................................................................................17
1.2 Instrument parameters........................................................................................................ 17
1.3 Introduction of analysis parts............................................................................................. 20
1.3.1 Instrument Appearance........................................................................................... 20
1.3.2 Instrument roof structure.........................................................................................23
1.3.3 Instrument Structure................................................................................................24
1.4 Structure and function........................................................................................................ 24
1.4.1 Operation Part......................................................................................................... 25
1.4.2 Analysis Part............................................................................................................25
1.4.2.1 Reagent & Sample tray...............................................................................26
1.4.2.2 Dispensing System......................................................................................27
1.4.2.3 Reaction Tray System................................................................................. 30
1.4.2.4 Stirring arm................................................................................................. 32
1.4.2.5 Washing Arm...............................................................................................34
1.4.2.6 Cooling system........................................................................................... 34
1.4.2.7 Optical inspection system........................................................................... 36
1.4.2.8 water system.............................................................................................. 36
1.4.2.9 Alarm system............................................................................................. 38
Chapter 2 Installation........................................................................................................................ 39
2.1 Unpacking...........................................................................................................................39
2.1.1 Unpacking Steps......................................................................................................39
2.1.2 Instrument Transporting..........................................................................................40
2.2 Installation Requirement.................................................................................................... 40
Automatic biochemistry analyzer BK-200 user manual

2.2.1 Space Requirement................................................................................................. 41


2.2.2 Power Requirement.................................................................................................42
2.2.3 Environmental requirement.................................................................................... 43
2.3 Water supply and drainage..................................................................................................44
2.4 Installation steps............................................................................................................... 44
2.4.1 Hardware installation.............................................................................................. 44
2.4.2 Software Installation............................................................................................... 45
2.4.2.1 Preparation before installation....................................................................45
2.4.2.2 Install necessary components..................................................................... 45
2.4.2.3 Installation Procedure................................................................................. 45
2.4.3 USB driver installation............................................................................................49
2.4.4 Software Uninstallation...........................................................................................57
2.4.5 Printer installation and inspection...........................................................................57
2.4.6 Scanner installation................................................................................................. 57
2.4.7 First boot................................................................................................................. 57
Chapter 3 Software Operation.......................................................................................................... 59
3.1 Software Operation.............................................................................................................59
3.1.2 Language Selection................................................................................................. 60
3.2 Software Interface...............................................................................................................62
3.2.1 Software Composition.............................................................................................62
3.2.2 Keyboard function...................................................................................................65
3.2.3 Software Function Chart......................................................................................... 65
3.3 Software Operation.............................................................................................................66
3.3.1 Movement method of the cursor............................................................................. 67
3.3.2 Choosing method of button.....................................................................................67
3.3.3 Forms Open.............................................................................................................67
3.3.4 Operation of list box and the scroll bar...................................................................68
3.3.5 Radio box and check boxes.....................................................................................69
Chapter 4 Testing Process................................................................................................................70
4.1 Equipment Standard........................................................................................................... 70
4.2.1 Test Procedure.........................................................................................................70
4.2.2 Clean probe action sequence...................................................................................70
4.2.3 Optical measurement operation sequence...............................................................70
4.2.4 Reagent cooling system.......................................................................................... 71
Automatic biochemistry analyzer BK-200 user manual

Chapter 5 Instrument Operation Principle....................................................................................... 72


5.1 Initialization Principle........................................................................................................ 72
5.1.1 Action Position........................................................................................................ 72
5.1.2 Analysis Process......................................................................................................72
5.1.3 Optical Characteristics............................................................................................ 72
5.2 Analysis Method................................................................................................................. 73
5.2.1 Analysis Types.........................................................................................................73
5.2.2 Calibration Method................................................................................................. 78
5.2.3 Calibration Type......................................................................................................87
Chapter 6 Instrument Operation........................................................................................................89
6.2 Detailed Operation..............................................................................................................91
6.2.1 Inspection before test.............................................................................................. 91
6.2.2 Power on and Login................................................................................................ 91
6.2.3 Light checking.........................................................................................................92
6.2.4 Confirm the temperature of the reaction tray......................................................... 93
6.2.5 Confirm analysis condition..................................................................................... 93
6.2.5.1 Confirm the parameter of items..................................................................93
6.2.5.3 Settings of the calculating items.................................................................95
6.2.6 Preparation of reagent (reagent information)........................................................ 96
6.2.6.1 Use and precautions of reagent...................................................................96
6.2.6.2 Reagent Login.............................................................................................96
6.2.6.3 Residual amount of reagent....................................................................... 98
6.2.7 Login Calibration.................................................................................................... 98
6.2.8 Login Quality control............................................................................................100
6.2.9 Sample Input and Testing.....................................................................................101
6.2.10 Test result Query................................................................................................. 105
6.2.11 Sample Retest...................................................................................................... 108
6.2.11 Operation after test.............................................................................................. 109
Chapter 7 Calibration and Quality Control.....................................................................................109
7.1 Calibration........................................................................................................................ 109
7.1.1 Calibration Parameters Settings............................................................................109
7.1.2 Calibration test...................................................................................................... 110
7.1.3 Calibration test result Query................................................................................. 111
7.2 Quality Control................................................................................................................. 113
Automatic biochemistry analyzer BK-200 user manual

7.2.1 QC setting ( See Section 6.2.8 )............................................................................ 113


7.2.2 QC test...................................................................................................................113
7.2.3Quality Control query............................................................................................ 113
7.3 Factor correction.............................................................................................................. 114
.7.4 Calibration and quality control flow chart...................................................................... 115
Chapter 8 User Mangement and About...........................................................................................115
8.1 User Mangement...............................................................................................................115
8.2 About.................................................................................................................................116
Chapter 9 Maintenance................................................................................................................... 117
9.1 Prepare before System Maintenance................................................................................ 117
9.1.1 Required Tools...................................................................................................... 117
9.1.2 Purified water........................................................................................................ 117
9.1.3 Washing Solution.................................................................................................. 117
9.2 Software Maintenance...................................................................................................... 118
9.2.1 Initialization...........................................................................................................118
9.2.2 Instrument Adjustment.......................................................................................... 118
9.2.2 .1 Position Adjustment...............................................................................118
9.2.3 Optical System Maintenance................................................................................ 119
9.2.3 .1 Light Spot Inspection.............................................................................119
9.2.3 .2 AD Stability Adjustment........................................................................119
9.2.3.3 AD Absorbance Test............................................................................... 119
9.2.4 Thermostat System................................................................................................120
9.2.5 Water System Maintenance...................................................................................120
9.3 Check before test.............................................................................................................. 121
9.3.1 Power on Checking............................................................................................... 121
9.3.2 Purified water, waste water and cooling alarm checking..................................... 122
9.3.3 Pump Air Out........................................................................................................ 122
9.4 Software Problem............................................................................................................. 122
9.4.1 Printing Problem................................................................................................... 122
9.4.1.1 change print paper type.............................................................................122
9.4.1.2 Edit Test Report........................................................................................ 123
9.4.2 Closed Software can not be opened...................................................................... 125
9.4.3 Mismatching of the software and the machine..................................................... 125
9.4.4 Database Operation Error......................................................................................127
Automatic biochemistry analyzer BK-200 user manual

9.4.5 Other problems......................................................................................................127


9.5 Equipment Maintenance................................................................................................... 128
9.5.1 Regular clean, inspection and replace parts..........................................................128
9.5.2 Users regular replacement accessories sheet........................................................ 129
9.5.3 Maintenance procedure......................................................................................... 130
9.5.3.1 Dispensing probe maintenance.................................................................130
9.5.3.2 Reaction plate maintenance...................................................................... 138
9.5.3.3 Maintenance of the light source lamp...................................................... 143
9.5.3.4 Cleaning mechanism maintenance........................................................... 145
9.5.3.5 Mixer probe maintenance......................................................................... 147
9.5.3.6 Reagent sample tray maintenance............................................................ 150
9.5.4 Daily operation......................................................................................................154
9.6 instrument failure and treatment.......................................................................................155
9.6.1 The way to deal with the failure of alarm............................................................. 155
9.6.2 The content and solution of alarm information.................................................... 158
Appendix A Electrical Schematic Diagram................................................................................... 168
Appendix B Liquid road connection diagram............................................................................... 169
Appendix C Products supporting reagents.................................................................................... 170
Appendix D Cross contamination reference table......................................................................... 173
Automatic biochemistry analyzer BK-200 user manual

Preface
Thank you for purchasing BK-200 automatic biochemistry analyzer
Intended use
The instrument for quantitative analysis of human serum, plasma, urine, cerebration
fluid and other samples of the clinical chemical composition. Do not use for other
purposes.
Using object
This manual is intended for the clinical laboratory technologists operating this
instrument.
Before using the product, please carefully read the contents of this manual, the correct
use of the product. Keep this manual in a safe place for easy reference. If you do not
follow the precautions described in this manual, we will not guarantee the
maintenance.
Software used in the product
Auto Biochemical Analyzer software for Jinan BIOBASE Biotech Co., Ltd. to obtain
software license software license.

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Automatic biochemistry analyzer BK-200 user manual

Guarantee
Warranty period
One year from the date of completion of the installation.
Ensure that content
In the warranty period, if any failure caused by the design, manufacturing defects,
will be repaired free of charge, our company will take the appropriate content of the
corresponding countermeasures.
Statement
Jinan BIOBASE Biotech Co., Ltd. (hereinafter referred to as "Jinan BIOBASE ") has
the final interpretation of this manual.
The Company shall be responsible for the safety, reliability and performance of the
product only if all of the following requirements happened:
1. Assembly operations, expansion, re-adjustment, improvement and repair by the
Company recognized professionals;
2. All repairs involving replacement parts and supporting the use of accessories,
supplies are original of the Company (original) or approved by the Company;
3. the related electrical equipment is according to national standards and the use of the
manual requirements;
4. Product operation is carried out according to the instruction manual.
Disclaimer
The Company shall not be liable for any equipment failure or damage, or for any
direct or indirect damage that may occur during the use of the equipment.
1. Malfunction or damage due to violation of the instructions, precautions, and
intended use of this manual.
2. Malfunction or damage caused by repair or alteration of the other company.
3. Malfunction or damage caused by use instruments of other company at the same
time .
4. Malfunction or damage caused by operating environment not corresponding to the
specified operating environment (power conditions, installation environment, etc).
5. Malfunction or damage caused by natural disasters such as earthquakes and floods.
6. Malfunction or damage caused by the company unaware of the movement or
transfer (transport) after installation.

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Automatic biochemistry analyzer BK-200 user manual

After-sales service and contact information


After-sales service
Please contact with Jinan BIOBASE company IVD after-sales service department
Service Email: service_IVD@biobase.cc
Maintenance procedures
1. Confirm the fault and repair methods: First, contact with Jinan BIOBASE after-
sales service department to confirm the fault condition, and confirm the repair is on-
site repair or depot repair.
2. Maintenance costs: according to the specific situation ask Jinan BIOBASE to
consultations resolved.
3. Freight: If the instrument is shipped to Jinan BIOBASE repair, the user must bear
the freight (including customs fees).
Return steps
1. Obtain a Return Permit. And Jinan BIOBASE after-sales service department to
contact and inform the product serial number (has been marked on the left side of the
instrument board), indicating the reasons for the return, if the product serial number
can not be legible, BIOBASE will not be returned .
2. In the premise of obtaining the rights to return the goods, please follow the
requirements of Jinan BIOBASE Biotech Co., Ltd company for the relevant
procedures.
Contact information

Company: BIOBASE Biodustry(Shandong)Co., Ltd

Company Address: South Gongye Road NO 51, Jinan, China


Service Email: service_IVD@biobase.cc
Fax: +86-531-81219804
Zip code: 250000

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Automatic biochemistry analyzer BK-200 user manual

Product manual
Dimensions and weight of the instrument
BK-200: Dimensions: 950mm (length) × 603mm (width) × 505mm (height);
Weight: 65Kg
BK-200(with bottom cabinet): Size: 950mm (length) × 603mm (width) × 1075mm
(height); Weight: 110Kg
Description of service life
The service life of this instrument is 5 years from the date of completion of
installation and debugging of the instrument. After 5 years, the instrument will be
discarded. Please follow the relevant regulations.
Product Categories
The classification criteria are described below:
1. Overvoltage Category: Overvoltage Category (Class II)
2. Pollution Degree: Pollution Degree (Class Ⅱ)
3. Installation of environmental conditions:
a) Indoor use;
b) Altitude not exceeding 2000m;
c) The temperature range of 15 ℃ ~ 30 ℃;
d) The maximum relative humidity is 85% when the temperature is below 30 ℃;
e) The supply voltage fluctuates not more than ± 10% of the nominal voltage;
f) Typical transient overvoltage present on the mains supply;
g) Note: The transient over-voltage of the nominal rating of GB 16895.12 specified
pulse withstand voltage (over-voltage) Category Ⅱ.
h) The applicable rated pollution level.
4. Equipment categories: laboratory equipment
5. Connection to the network power supply: Removable power cord
6. Operating conditions: continuous

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Automatic biochemistry analyzer BK-200 user manual

Transportation and storage

Transport
In the packaging states, the instruments conduct transportation according to the
requirements of the transport contract, in the transport process to prevent rain and sun
exposure, to prevent severe impact, weight and dumping.
Note: If the instrument has been unpacked, before moving the instrument, please re-
packaging equipment before transport.
Store
Packaged instruments should be stored at 0℃ to 40℃ and relative humidity not more
than 85%, non-corrosiveness gases and in a well-ventilated environment.

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Automatic biochemistry analyzer BK-200 user manual

User manual instructions


File Name: BK-200 Automatic Biochemistry Analyzer User's Manual
Version: V2.0 version
Contents: This manual describes in detail the use of the product, function and use of
methods to ensure that the detection of clinical laboratory technician to carry out a
smooth daily testing work, documented the relevant routine maintenance. This
manual uses the BK-200 automatic biochemistry analyzer as an example. The pictures
in this manual are for illustrative purposes only and are not intended for other
purposes. The actual picture please refer to our products. In this manual, the mouse
operation is used as an example to explain various operation methods.
Copyright notice
This User's Guide contains proprietary information protected by copyright. No part of
this manual can be reproduced, photocopied, modified, or translated into any
language, including photocopying, reproduction, transcription, or otherwise, without
the prior written consent of the Company.
Modify the instructions
If the contents of this manual are changed, the user will not be notified.

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Automatic biochemistry analyzer BK-200 user manual

Safety Information
This chapter introduces the safety symbols and their meanings, summarizes the safety
hazards and precautions for using the instrument, and the specific meaning of the
label affixed to the instrument. It also lists the content of toxic and hazardous
substances contained in each part of the instrument is in accordance with the relevant
standards or not.
Safety Symbols
Various safety symbols are used in this instruction manual to remind you of the
precautions to be taken during operation. As shown in the following table:
Symbols Slogan Introduction
Biological infection Indicates a risk of biological infection, if not
in accordance with the instructions, there may
be the risk of biological infection.
Electric shock Indicates a risk of electric shock. If exposure
can result in personal injury.

Warning Indicates a potential hazard. If not follow


these instructions could result in personal
injury or damage to the instrument.
Burns Indicates a risk of burns. If touched or not in
accordance with the instructions, may be
burned
Moving parts Indicates a potential hazard. If not follow
these instructions could result in personal
injury

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Automatic biochemistry analyzer BK-200 user manual

Safety Precautions
For the safe use of this instrument, please carefully read the following safety
precautions. Any violation of the following safety precautions may result in personal
injury or damage to the instrument.
Warning:

If you do not follow this instruction manual to use this


instrument, the instrument's protective measures may be
invalidated.
Biological hazard protection
For effective protection against biohazard, observe the following precautions.
Biological infection:

 Incorrect use of the sample may result in infection. Do not


touch samples, controls, calibrators, admixtures, and waste
directly. Be sure to wear gloves and work clothes to
prevent infection when working, if necessary, wear
protective glasses.
 If the sample comes in contact with the skin, immediately
follow the user work standards to treatment, and consult a
doctor.
Electric shock protection
To prevent electric shock, observe the following precautions.
Electric shock:

 Do not open the back cover or the side cover when the
main power is turned on.
 Reagent and sample are spilled in the instrument, which
may cause malfunction and electric shock. Do not place
samples or reagents on the instrument. If splash occurs,
please turn off the power immediately and contact
Service.

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Automatic biochemistry analyzer BK-200 user manual

Moving parts protection


Observe the following precautions to prevent personal injury from moving parts when
the instrument is working.
Warning:

 Do not touch the moving parts of the instrument while the


instrument is working. The moving part includes a sample
needle, mixer and cleaning arm.
 Do not put your fingers or hands into open parts when the
instrument is working.
Burn protection
To prevent burns from halogen lamps, observe the following precautions.
Burn protection:

 Do not touch the light source when the system is turned


on.
 Replace the halogen lamp, you must turn off the power,
the halogen lamp to be cooled before changing the lamp ,
otherwise the high temperature of the halogen lamp and
light box can cause burns.
To prevent personal injury caused by the light source
To prevent personal injury caused by light sources or bar code scanners, observe the
following precautions.
Burn protection:

 When working with the instrument, do not look directly


into the light source or the beam emitted by the barcode
scanner, which can cause eye damage.
 Before checking the light source, turn off the main power
and allow at least 15 minutes for the light source to cool
down. Do not touch the lamp to prevent burns before it
cools down.
Protection against chemical hazards
Warning:

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Automatic biochemistry analyzer BK-200 user manual

Some reagents, concentrated cleaning fluids may damage the


skin. Be careful to use reagents, concentrated cleaning fluids,
to prevent direct contact with the hands and clothes. In case of
accidental contact with hands or clothes, rinse immediately
with soap and water. In case of contact with eye, immediately
rinse with plenty of water and consult an ophthalmologist.

Waste treatment
To prevent waste liquid from causing environmental pollution and personal injury,
observe the following precautions when treating waste liquid.
Biological infection:

 Reagent, QC, calibrator, cleaning fluids, waste liquid


contains certain components which are subject to pollution
regulations and emission standards control. Observe local
emission standards and consult the relevant reagent
manufacturer or distributor.
 When treating waste, be sure to wear gloves and work
clothes to prevent infection, if necessary, wear protective
glasses.
Instrument treatment
Dispose of the instrument according to the following requirements.
Warning:

The obsolete instrument contains some substances which are


subject to pollution regulations control. Dispose of obsolete
equipment in accordance with local waste disposal standards.

Fire and explosion protection


To prevent fire and explosion, observe the following precautions.
Warning:

Alcohol is flammable and must be used with extreme caution.

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Automatic biochemistry analyzer BK-200 user manual

Operation Precautions
To use the instrument correctly and effectively, please read the following precautions
carefully.

Intended use
Warning:

The instrument is used for quantitative analysis of serum,


plasma, urine, cerebrospinal fluid and other samples of the
clinical chemical composition.

According to the results for clinical analysis,please consider the


clinical symptoms or other test results.

Operator
Warning:

This instrument is only for use by inspection professionals,


doctors or labors who have participated in BIOBASE or agency
training.

Environment
Attention:

Install the instrument correctly according to the installation


environment specified in the instruction manual. Installation,
use of this instrument outside the specified conditions may
result in unreliable results and may result in damage to the
instrument.

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Automatic biochemistry analyzer BK-200 user manual

Electromagnetic wave and noise protection


Attention:

Do not place other equipment which generates unusual noise


near the instrument. Please turn off the equipment that emits
electromagnetic waves in the room where the equipment, such
as mobile phones, radio transceivers, etc., and do not use other
CRT monitors near the instrument. Noise, electromagnetic
interference may cause instrument failure. Do not use other
medical devices near the instrument. The electromagnetic
waves emitted by this instrument may cause malfunctions of
other medical devices

Instrument operation
Attention:

(1). Use the instrument according to the operating instructions.


Improper use may result in incorrect measurement results and
may even result in instrument damage or personal injury.

(2). Before using the instrument for the first time, please carry
out calibration, quality control, to confirm the instrument is
working properly.

(3). When using the instrument, the quality control program


must be carried out. Otherwise, the reliability of the result can
not be guaranteed.

(4). Do not open the sample / reagent tray cover during


working.

(5). The USB interface of the analyzer is configured to be


connected to the USB port of the operation unit. Do not connect
to any other equipment. Use the special cable provided by our

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Automatic biochemistry analyzer BK-200 user manual

company to connect the analyzer and the operation unit.

(6). The operation part is a computer which runs the special


operation software of the instrument. Installation of any other
software or hardware on this computer may interfere with the
proper operation of the instrument. Do not run other software
while the instrument is working.

Computer viruses can destroy software and data. Do not use the
computer for other purposes or connect to the Internet.

( 7 ) Do not touch the monitor, the mouse, or the keyboard


with wet or sticky chemicals.

(8)Do not turn the power switch on again within 10 seconds


after turning off the analyzer's main power supply. Otherwise,
the instrument may enter the protection state. If the instrument
enters the protection state, turn the main power off and then on
again.

Instrument maintenance
Attention:

(1). Follow the instruction manual to maintain the instrument.


Improper maintenance may result in incorrect results and may
even result in damage to the instrument or personal injury.

(2). Instrument long-term placement, the surface may be


accumulated dust. When cleaning, wring dry with a clean, soft
cloth and gently wipe the surface, soak a small amount of soap
if necessary. Do not use organic solvents such as alcohol. After
cleaning, dry the surface with a dry cloth.

Before cleaning, turn off all power to the instrument and unplug
the power cord. Take necessary measures to prevent water
droplets from entering the instrument during cleaning. Doing so

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Automatic biochemistry analyzer BK-200 user manual

may cause damage to the instrument or personal injury.

( 3 ) Inspection and maintenance of the main components,


such as the replacement of halogen lamps, sample needle, stir
bar, injection components, the calibration analysis must be
carried out.

Parameter settings
Attention:

The instrument needs to set the sample volume, reagent volume,


measurement wavelength and other parameters, set these
parameters, please follow the instructions, and refer to the
instructions provided with the reagent.

Sample
Attention:

(1) Use the full separation serum samples and urine samples
that do not contain suspended solids. If the serum sample
contains fibrin, or urine samples containing suspended solids
and other insoluble impurities, are likely to block the needle,
affecting the analysis results.

If the sample contains drugs, anticoagulants, preservatives, etc.,


may interfere with the analysis results.

Samples containing hemolysis, jaundice, chylous particles may


affect the analysis results, it is recommended to do a blank
sample test.

(2) Please use the correct sample storage measures. Incorrect


sample storage measures may alter the composition of the
sample and result in incorrect analysis result.

(3) To prevent sample volatilization, do not leave the sample

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Automatic biochemistry analyzer BK-200 user manual

open for a long time. If the sample volatilizes, it may lead to


incorrect analysis results.

(4) Some samples may not be analyzed based on the test


parameters and the reagents used. For these samples, please
consult the manufacturer of the reagents or distributors and
BIOBASE service or distributors.

(5) If some samples need to be pretreated for analytical


purposes, consult the relevant reagent manufacturer or
distributor.

(6) The instrument has a sampling volume requirements. When


sampling, please follow the instructions in this manual to
determine the appropriate sampling volume.

(7) Before testing, make sure the sample is placed in the correct
sample position, otherwise the correct result may not be
obtained.

Reagents, calibrator, QC
Attention:

(1)When using this instrument for analysis, appropriate


reagents, calibrators and QC are required.

(2)Please select the appropriate reagent according to the


instrument. If you are not sure whether the reagents are
available, consult BIOBASE service or distributors.

(3)Observe the instructions of the manufacturer or distributor,


and use and store reagents, calibrators, and QC.

Improper storage of reagents, calibration solutions, and QC


may result in failure to obtain correct test results and best
instrument performance, even during the expiration date.

(4)After checking the reagents, perform a calibration analysis.

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Automatic biochemistry analyzer BK-200 user manual

Without a calibration analysis, the correct analytical results may


not be obtained.

(5)The cross-contamination of the reagents may affect the


analysis results; Reagent cross-contamination information,
please consult the reagent manufacturer or BIOBASE

Data backup
Attention:

The instrument has the function of automatically storing data on


the hard disk of the computer. However, if the hard disk data is
deleted or the hard disk is damaged, the data can not be
recovered. Please back up the analysis data and measurement
parameters to other removable storage devices regularly.

Computers and printers


Attention:

For computer and printer use, please refer to the operating


instructions.

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Automatic biochemistry analyzer BK-200 user manual

Chapter 1 Main Introduction


1.1 System Composition
Biobase BK-200 is mainly used for the quantitative determination of serum, plasma,
urine, cerebrospinal fluid of clinical biochemistry project, immunization programs,
therapeutic drug monitoring and drug abuse monitoring. The system consists of
analyzer, computer, LCD monitor, keyboard, mouse and printer. The appearance of
Biobase BK-200as Figure1-1.

Figure 1-1 Biobase BK-200


1.2 Instrument parameters
Table 1-1 Instrument Parameters
Performance index Standard

200 tests per hour(BK-200)/280 tests per hour(BK-


Test Speed
the basic 280)
characters
Wavelength 340~800nm;After splitting back system, acquisition
Range and processing simultaneously wavelength

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Automatic biochemistry analyzer BK-200 user manual

Wavelength
±2nm
accuracy
Reaction
37℃±0.1℃
Temperature
Test Item Up to 56 test items

Test Method End-point, rate method, fixed-time, immunonephelometry

Total of 49 positions; edit calibration QC and sample


Sample Position arbitrarily; original test tube, centrifuge tube, standard
cup are available
Sample Types Serum,urine, pleural effusion and other body fluids

2~70ul(0.1ul stepping); equipped with high precision


Test Sample Size
Sample million times life syringes
system Sample
150μl sample fluid volume requirements
margin

Liquid level detection,remaining detection,vertical


dispensing probe
collision detection

dispensing probe
Inner and outer walls cleaning
cleaning
Reagent
Reagent dish with frozen;Liquid medium conduction
dish,reagent
cooling refrigeration; total of 56 reagent positions
position
Reagent
20~350ul(1ul stepping)
volume
Reagent Reagent bottle
18mL 、50mL
system Specifications
Reagent margin Reagent solution requires greater than 1mL
Liquid level detection,remaining detection,vertical
Reagent probe
collision detection
Reagent probe
Inner and outer walls cleaning
cleaning

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Automatic biochemistry analyzer BK-200 user manual

Reagent storage
2℃~8℃ storage 24 hours working
temperature
Reaction system Discrete
Cuvette optical
6mm
path
The number of
6 groups, each group of 20, a total of 120
cuvettes
Reaction time About 10 minutes
The reaction
120~450ul
liquid volume
Light source 20W/12V Long life quartz halogen
Photoelectricity
8 imported photoelectricity receiver
receiver
Reaction
system Absorbance range 0~3.0Abs

Resolution Ratio 0.0001

One-point, two-point, factor, turbidimetry, log4p, log5p,


Calibration
polygon , spline and so on

QC interval,month QC;add QC at any time;up to 6 QC for


QC
one items
Automatic Automatic cleaning cuvettes, reagent probe, dispensing
cleaning probe, stirring probe
Stirring Speed adjust;Teflon coating; Stirring alone after filling
System agent
Interface USB;Internet access

Data Processing Showing reaction curves and data simultaneously


Ordinary inkjet or laser printer; Chinese and English
Data system Printer
reporter; the report supports user-defined mode
LIS System
LIS system can be connected
Connection
The whole weight 65Kg(BK-200)/110Kg(BK-200 with bottom cabinet)

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Automatic biochemistry analyzer BK-200 user manual

system 950mm(L)×603mm(W)×505mm(H)(BK-

Dimensions 200)/950mm(L)×603mm(W)×1075mm(H)(BK-200 with

bottom cabinet)

Power(VA) 300VA(BK-200)

Water
5L/h
Consumption
Power supply AC110/220V±10%,60/50Hz

Storage temperature of the system is 0 ℃ ~ 40 ℃,


fluctuation <± 2 ℃ / H; system storage humidity is lower
Installation than 80% RH, non-condensing; when the system is
conditions Environment working, the ambient temperature is 15 ℃ ~ -30 ℃,
fluctuation <± 2 ℃ / H; when the system is working,
humidity 35% RH ~ 80% RH, non-condensing;The
altitude is no more than 2000 meters.

1.3 Introduction of analysis parts


The structure is based on the “two trays + one probe + one stirring”(reaction tray and
reagent& sample tray, one dispensing probe, one stirring arm. The dispensing probe is
used for adding sample, reagent 1 and reagent 2. Stirring arm is used for mixing
reagent and sample. Optical measurement part adopts after spectrophotometry to the
cuvettes for photoelectric collection. During the test, the cuvettes will be washed
automatically by the cleaning probes.
1.3.1 Instrument Appearance

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Automatic biochemistry analyzer BK-200 user manual

Figure 1-2 Front view

Figure 1-3 Right side view Figure 1-4 Left side view

Figure 1-5 Rear view

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Automatic biochemistry analyzer BK-200 user manual

No Name Remark
1 header Protect adding system;detection unit;sample and reagent
tray
2 window Watch adding system and detection units from here
3 Front panel Strike when maintenance the machine
4 alarm indicator Liquid level alarm and temperature alarm
lamp
5 Right side Strike when adding cooling oil and maintenance water
panel system
6 Power switch Operation switch and cooling switch
7 Left side panel power switch is located on the left side panel
8 L-type support Connect grounding line,water alarm float switch and water
tube connection
9 Power panel Open or close power supply and power line connection
10 Earth bolt Used to connect earth line
11 Aviation joint Connect water alarm float switch to alarm purifier and
waste water
12 Outfall Connect armored tube, empty waste water
13 Inlet Connect silicone tube, provide purifier water
14 Communicatio Used to connect analyzer and PC
n interface
15 Fuse Protect the safe operation of the circuit
16 Main switch Used to control the main power of the analyzer
17 Power line Connect power supply

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Automatic biochemistry analyzer BK-200 user manual

1.3.2 Instrument roof structure

Figure 1-6 internal instructure


No Name Remark
1 Reagent&Sam Put reagent bottle,sample cup and test tube
ple tray
2 Washing tank Clean reagent needle and sample needle
Extraction reagent and sample from reagent&sample plate,
3 Sample system
and distribute to the cuvettes
4 Stirring system Mix reagent and sample in the cuvettes
5 Reaction Fixed cuvettes,keep suitable temperature and provide
system reaction conditions
6 Cleaning Used to clean cuvettes
system

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1.3.3 Instrument Structure

1-Circuit board; 2-Water L frame; 3-dispensing arm; 4-Stirring arm; 5-Cleaning


cup;
6-Halogen lamp; 7-Fan support;8-Optical component;9-Cleaning arm;10-Wire
slot;11-Relay;12-Reagent& Sample tray;13-Pinboard;14-Sample pump;15-
Cleaning cup;16-Magnetic pump;17- Reaction tray;18-Coolant container;19-
Pump;20-Solenoid valve
Figure 1-7 Instrument Structure
1.4 Structure and function
The analyzer consists of operation part and analysis part, which are connected by
USB. As shown in Figure 1-8.

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Automatic biochemistry analyzer BK-200 user manual

Figure 1-8 System connection


1.4.1 Operation Part
Operation part consists of computer, monitor, keyboard, mouse and printer etc.
Operation system: Windows7 or above, 32 bits or 64 bits. Already installed Microsoft
.NET FrameWork 2.0 and software of the analyzer.
Computer Configuration: CPU frequency 3.5≥GHz, hard disk≥80G, memory≥2G,
network interface and USB interface.
Monitor: 17 inches or more, not less than 1280 x 1024 resolution.
Printer: Inkjet or laser printer,print the test report.
Mouse: Able to complete the operation of the software.
Keyboard : Able to edit each function of analyzer.
1.4.2 Analysis Part
Analysis section is mainly composed of reagent& sample tray, dispensing arm,
reaction system, stirring arm, washing arm, cooling system, optical system, liquid
system and alarm system.

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1.4.2.1 Reagent & Sample tray

1- sample positions; 2-outer ring; 3-inner ring


Figure 1-9 Reagent &Sample Tray Structure

As shown in figure 1-9, sample tray is divided into inner ring and outer ring and
sample positions, a total of 49 samples. We can put the standard cup that contain
sample, calibration liquid, quality control liquid in the designated position, through
the sample disc rotating to send samples to dispensing position of the dispensing arm.

1-Gear positioning plate; 2-Step motor; 3-Shaft; 4-Outline frame; 5-Support base
Figure1-10 Reagent&sample Tray Structure

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Automatic biochemistry analyzer BK-200 user manual

1-Above disk; 2-Middle disk; 3-Disk support; 4-Hand grip


Figure 1-11 Structure
As Figure 1-10 & 1-11 shows, reagent&sample tray consist of support pillars, frame,
tray shaft, positioning plate, driving motor, sample tray and the handle etc.
After turning on the power, the drive motor drives the gear to rotate, so that the
position of the first position is rotated to the sample position. When the sample is
tested, the driving motor drives the reagent sample plate to rotate, and the sample bit
number or the reagent position of the sample is rotated to the sample adding position.
When initializing, the same action with the power on.
When installation, must aim at the sample disk guide pin, make sample tray flat and
level, with the hand gently turns non-slip, then tighten the reagent tray handle. when
remove, screw the handle counterclockwise then take out whole sample tray .
When check movement, find the “Instrument Check”, Input Target value in “Target
Position” Click Y to check. “Zero Position” is back to original position.

1.4.2.2 Dispensing System


As Figure1-12 is shown, the dispensing arm is composed of dispensing arm,
dispensing pump and solenoid valve, which is controlled by solenoid valve and
plunger pump.

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Automatic biochemistry analyzer BK-200 user manual

Dispensing arm Dispensing pump


Figure 1-12 1.3.2.2 Dispensing System

As Figure1-13 is shown,dispensing arm consist of dispensing probe, cross arm, linear


optical axis, drive Motor and photoelectric switch etc.

1-Sample cap;2-Spline shaft;3-Main frame;4-Step motor left& right;5-

Pinboard;6-Step motor up&down;7-Dispensing probe;8-Left and right

synchronous belt;9-Up and down synchronous belt;10-Shaft bearing sleeve;11-

Pipe clamp;12-Up and down drive seat.

Figure1-13 Dispensing arm


Dispensing arm also used for adding sample and reagents.

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Automatic biochemistry analyzer BK-200 user manual

Dispensing arm is used to take quantitative sample from sample cup and fill into the
reaction cuvettes. dispensing probe have liquid level detection function. If dispensing
probe collide, it will execute anti-collision protection procedure. The probe will return
to the highest place and stop. Operator need to power off and power on again. After
power on, need to check dispensing probe’s mechanical position. If the position is
correct , please run the test again.
Dispensing probe volume range is 2ul-70ul, 0.1ul stepping. The minimum liquid level
detection sample volume is 50ul, the minimum requirement of sample volume is
above 150ul.
Dispensing probe withdraws fix quantify reagent from the reagent bottle and then add
to reaction cuvettes. The probe also have level senor which can detect the remaining
volume of the reagent. As figure 1-14 shown:

Figure1-14 Remaining volume of reagent


In the process of taking reagent, in case of reagent dilution, the probe takes reagent in
accordance with the “set quantitative+ allowance” rule and add in the reaction
cuvettes. Reagent volume is 20ul-350ul generally. The setting unit can be 1ul.
After turn on the power, the probe will first rise and move to the top of the cleaning
cup and drop down for washing, then rise up.
During testing, the probe follow the order sample position, reaction position, and
cleaning cup.

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Automatic biochemistry analyzer BK-200 user manual

After testing, if we need to add washing liquid to wash reaction tray cuvettes, select
“Clean fluid” in the “Washing and Blank ground” window. It can set the washing
liquid position in reagent tray and the amount and the reaction cuvettes that needed.
Generally, setting number is 28 and the volume is 300ul.

Click “ ”,initialization process is the same as the power on process.


In the process of drawing sample, the probe will detect the liquid level first, and then
go on falling more 3mm to draw the sample.

During testing, click “instrument check” button,as figure 1-15 shown, reagent

sample plate and rotating to a certain number,Click instrument check to test the

position of arms and trays, including the washing position, probe horizontal position
,probe vertical position and reaction cuvette position.

Figure 1-15 Sample arm adjustment interface Figure 1-16 Dispensing probe
component
As Figure 1-16 shown, the dispensing probe is consist of anti-collision probe, up fixed
screw, spring, adapter sleeve and nut.
1.4.2.3 Reaction Tray System
As figure1-17 shown, reaction tray system consists of tray, cover, cuvettes and
thermostat.
Reaction tray cover: rotated by stepper motor.
Cuvettes: cuvettes, total 120 units, can be replaced independently by micro organic
material, its standard optical path is 6 mm.

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Automatic biochemistry analyzer BK-200 user manual

Reflection cup group: a total of 6, each part is installed 20 cuvettes, fixed on the
reaction tray cover by two pins, as shown in figure 1-18.
Thermostat bath: air heating incubation, make samples and reagents reaction at 37 ℃.
At the same time monitor the temperature through the temperature control system.

Figure 1-17 Reaction Tray

1-cuvettes positioning plate;2-Reaction plate lamination;3-Reaction tray cap;

4-cuvettes group: total 6;5-cuvettes: total 120

Figure 1-18 Cover of Reaction Tray

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1-Optical fiber fixed plate;2-Dust board;3- Pillar support;4-Reaction tray

column;5-Reaction plate encoder;6- Big gear;7-Photoelectric switch;8-Fixed

base;

9-Small gear;10-Stepper motor

Figure 1-19 reaction tray programming

As figure 1-17、1-18、1-19 shown,shown, reaction tray consists of cover, tray,

drive motor, support pillar and optical fiber fixed plate etc.
After turning on the power, reaction tray rotates clockwise, move to the number 1
position.
When check movement, click “Instrument Check” ,choose

“ ”button,then input any cup number (1-120),click

“Y” to check. When finished, click “Zero Position”.


1.4.2.4 Stirring arm
The stirring arm consists of stirring arm and probes. The structure of stirring arm is
similar with dispensing arm. The difference is component: dispensing component and
stirring component.
As figure 1-20 shown, stirring arm consists of drive motor ,photoelectric switch, big
and small belt wheel, guide shaft etc.

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Automatic biochemistry analyzer BK-200 user manual

1-Spline shaft;2-Left and right belt wheel;3-Left and right driving motor;4-Up

and down driving motor;5-Stirrer cap;6-Stirrer;7-Stirring arm up and down drive

seat;8-Stirring arm frame;9-Up and down belt wheel

Figure 1-20 Stirring Arm


When power on, the stirring probe rises up ,swing left and right, stops at the top of
cleaning position , then fall down to the cleaning cup, when finish, back to upward
side.
Initialization process is the same motion state after turning on the power supply.
When run test, the stirring arm fall vertical to washing position first, then swing to
105 position in reaction tray to stir reaction fluid.
When check movement , click “Instrument Check”, click

“ ”, click “Zero”,“Reaction position”,


“Vertical position” to adjust the stirring arm respectively.

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1.4.2.5Washing Arm

1-Washing probe;2- Slider block;3-Photoelectric switch;4-Stepper motor;5

-Large motor cleaning arm base;6-Cleaning and pressing screw;7-fixed shaft

;8-Synchronous belt from the pulley;9-Synchronous belt;10-Synchronous

belt wheel up and down;11-Large motor cleaning cup main board;12-Pinboard

;13-Block

Figure 1-21 Washing Arm


As figure 1-15 shown, washing arm consists of washing probe, drive motor,
photoelectric switch etc.
When turning on the power supply, cleaning arm rises up and then drop into the
cuvettes, cleaning cuvettes, after cleaning up and stopped above the cuvettes.
When check movement, click “Instrument check”, choose

“ ”,then cooperate with reaction plate rotation to test set-up clean


probe position.
1.4.2.6 Cooling system

Cooling system adapts oil cooling system,the system consists of reagent & sample

tray, coolant circulation container, magnetic pump, heat exchanger, fan, float switch,
tubes and so on. The pipeline diagram as shown in figure 1-22.

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Automatic biochemistry analyzer BK-200 user manual

Figure 1-22 cooling system pipeline diagram


1. Cooling components of Reagent & sample tray
Cooling components of reagent & sample tray semiconductor cooling piece, water
head, the pagoda joint, water head stator, as shown in figure 1-23.

Figure 1-23 cooling components of reagent&sample tray


Semiconductor cooling piece is divided into cold and hot surface, please notice the
difference when installation.
2. Cooling control system
Cooling control system is mainly composed of cooling control panel and relay,
through cooling panel and solid state relay to achieve control of the magnetic pump
and cooling piece, keep reagent&sample tray temperature within 2 ℃ ~ 8 ℃.

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Automatic biochemistry analyzer BK-200 user manual

1.4.2.7 Optical inspection system


Optical detection system is used to measure the absorbance of the reaction fluid in the
cuvettes. The system consists of optical system and signal detection, its main function
is to detect the change of light intensity through reactant ,by the method of
photoelectric converting optical signal to electrical signals, by measuring electrical
signal variation amount to reflect the change of light intensity. Its working principle
diagram is shown in figure 1-24.
Optical system is composed of light source, colorimetric system and fiber optic

components, used to provide enough intensity monochromatic light, after the light

source produce stable and continuous spectrum, polychromatic light divide into
monochromatic light through the Fiber optic components, then after filtering the
specific wavelengths of monochromatic light into the signal detection system.
Signal detection system includes photoelectric conversion section and AD collection
and processing. Its main function is to convert the light of the transmission to
electrical signals, then amplify, analysis and processing, acquiring the light path
signal.

Figure 1-24 optical detection system


Light system adopts the after spectrophotometry techniques, Wavelength range is 340
-800 nm (three wavelengths can be defined by the user).
1.4.2.8 water system

Water system includes water pump liquid tube and liquid condensate drain tube,The

whole water system check appendix B.


1. Pump and valve fluid tube

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Automatic biochemistry analyzer BK-200 user manual

Pump and valve installation as shown in figure 1-25, seven diaphragm pump, five
Solenoid valve is fixed on the plate from left to right in turn.

Figure 1-25 pump and valve installation


Pump and valve fluid tube connection diagram is shown in figure 1-26

Figure 1-26 pump and valve fluid tube connection diagram


Among them, the dotted line frame for the reserved defoaming function.
2. Condensate water drain tube
Because of reagent&sample trays have 24-hour cooling function, may accumulate a
certain amount of condensed water in reagent&sample dish, If don't put these
condensate water out may lead to freeze that affect reagent sample tray movement. So
set the condensate drain fluid way,through L frame joint connection, will discharge
condensed water.Shown as Figure 1-27.

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Automatic biochemistry analyzer BK-200 user manual

Figure 1-27 Condensate water drain tube


1.4.2.9 Alarm system
Alarm system includes reagent&sample tray temperature alarm, waste fluid alarm,
pure water alarm, cooling liquid level alarm

Figure 1-28 alarm indicator diagram


Reagent&sample tray temperature alarm: when the temperature of the
reagent&sample tray above 50 ℃, the machine will alarm with the corresponding
alarm lights flashing.
Waste fluid alarm: when waste water is full, the machine will alarm with the
corresponding alarm lights flashing.
Pure water alarm: When the pure water is lacking, the machine will alarm with the
corresponding alarm lights flashing.
Cooling liquid level alarm: when the coolant level is low, the machine will alarm with
the corresponding alarm lights flashing.

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Chapter 2 Installation
In order to ensure the normal operation of the instrument after installation, only
person authorized by BIOBASE is allowed to doing the initial installation and settings.
2.1 Unpacking
2.1.1 Unpacking Steps
After the goods arrival, please carefully check the instrument packaging, to see if
there is physical damage. If any damage, please contact with BIOBASE or local
distributor. After confirming no external damage, unpacking follow steps below:
●Up Place package box as the Up arrow
●Open the accessory box and check whether object is complete according to the
packing list or not. If there is any missing, please contact with BIOBASE or local
distributor.
●Carefully check the instrument appearance, if there is any damage, please contact
with BIOBASE or local distributor.

Figure 2-1 before unpacking

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-2 spectrophotometry unpacking


2.1.2 Instrument Transporting
●Ensure all parts of instrument are in good appearance without damage before
transporting;
●All moving and transportation must keep instrument upright direction, do not tilt or
side up;
●Avoid vibration while transporting, please check and debug after transporting. If all
is ok, please follow chapter 2.2.
2.2 Installation Requirement
Install the instrument as shown in Figure 2-3

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-3 Install the instrument


In Figure 2-3, the connecting lines indicate the corresponding piping or lines.
2.2.1 Space Requirement
To convenient for the equipment operation maintenance and repair, automatic
biochemical analyzer need to satisfy the following conditions when installation.
a). The distance between the left and right sides against the wall should be greater
than 50 cm

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Automatic biochemistry analyzer BK-200 user manual

b). The distance between the rear panel against the wall should be greater than 50 cm;
c). The distance between front side of the analyzer and other instruments should be
greater than 100 cm;
d.) The space of the waste liquid discharging device and the pure water supplying
device should be ensured while installation.

Figure 2-4 Space requirement


2.2.2 Power Requirement
Power supply: AC220V + 22 v, 50 Hz;
Instrument power: 300 W;
Instrument is equipped with a three-core power cord: red is live wire, blue is neutral
wire, yellow-green to ground, connection as shown in figure 2-5:

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-5 power wiring


The electrical socket used for this instrument needs to be well grounded (at least three
5A sockets can be used). Large electrical equipment, such as air conditioners
refrigerators and ovens, should not be used with the same socket.
The ground bolts are located on the rear panel L, and the ground wire must be
connected. The protective grounding must be good. As shown in Figure 2-6

Figure 2-6 The ground bolts

Warning
The protective grounding must be well protected to against electrical shock and
instrument malfunction.
2.2.3 Environmental requirement
Environment temperature of 15 ℃ ~ 30 ℃;
Relative humidity is 40% ~ 85%;
Atmospheric pressure is 76 kpa to 106 kpa;

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Automatic biochemistry analyzer BK-200 user manual

BK series full automatic biochemical analyzers are only in indoor use. The
environment should be clean, without mechanical vibration and noise source and the
power interference;
The ground should be flat and of sufficient strength.
Don't get analyzer close to brush type generator, flashing fluorescent, and often
switching electric contact device;
Avoid direct sunlight or in front of heat source and pouring;
Keep the instrument well ventilated.

Note:

The instrument will not guarantee the accuracy of the normal operation and test data
in the rugged environment mentioned above. If the temperature and humidity cannot
meet the above requirements, please use the air conditioning equipment.
In the working process, the instrument can produce heat and it is discharged through
the instrument back. Working environment should be kept well ventilation and
ventilation equipment can be used when necessary. Direct flow of air should be
avoided to the instrument, or it may affect the accuracy of the instrument test.
2.3 Water supply and drainage
The following requirements of water supply and drainage must be met before the
instrument is delivered:
Instrument requires deionized water, the conductivity below 1μs / cm, water
consumption is 5L per hour. We recommend to use 15L water machine.
Ensure that the instrument water supply hole and pipe installation should be
unimpeded. In addition, the inlet hole of L rack should be higher than the pure water
barrel, and difference of feed water level should be less than 50cm.
Ensure that the instrument drain hole and pipe installation should be unimpeded, and
the equipment L rack outlet hole should be higher than the waste barrel (or waste
discharge), waste pipe length should not exceed 2m.
2.4 Installation steps
2.4.1 Hardware installation
Company professionals handle the instrument hardware system installation. It is
recommended that the user only carry out normal maintenance, and do not allowed to
other disassembly and installation of the instrument

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Automatic biochemistry analyzer BK-200 user manual

2.4.2 Software Installation


By the company professionals for installation of instrument operation software system,
without exception, users are not allowed to uninstall the software. If must reinstall,
according to the following steps:
2.4.2.1 Preparation before installation
This software should be supported by Windows 7 or upper.
2.4.2.2 Install necessary components
Click the setup.exe in the folder, the Net2.0 framework software is installed
automatically. If Net2.0 framework is not installed, you must install the Microsoft.
NET Framework 3.5.
Installation method: click into the folder ". NET3.5", run "NetFx35.exe" to start the
installation of Microsoft. NET Framework 3.5.
2.4.2.3 Installation Procedure
Step 1: Put the installation CD into the computer's CD-ROM, find the biochemical
analyzer control software files:

Step 2: Open the folder Select "setup.exe", as shown below:

Figure 2-7 Software Installation Procedure


Step 3: The pop-up dialog box is displayed, install the .NET2.0 framework, as shown
in Figure 2-8. Click the button to install the software automatically, as shown in
Figure 2-9.

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-8 Software Installation Procedure

Figure 2-9 Software Installation Procedure


Note: setup.exe automatically detects whether the software Net2.0 framework exists.
If not, then automatically install. If it exists, skip step 2, directly to the operation of
step 3.
Note: If the installation of the framework fails, you need to manually install the

framework, as follows: Open the folder: ;

As shown in Figure 2-10, double-click: into the installation

process, just follow the prompts to install.

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-10 Software Installation Procedure


Step 4: After the installation of the framework is complete, enter the BIOBASE BK-
200 installation wizard, as shown in Figure 2-11. Click “Next ” to enter the
installation folder.

Figure 2-11 Software Installation Procedure


Step 5: Select the software installation path, the default path is D: \ Program Files \
SetupBK-200 \, click “Next “to confirm the installation.

Figure 2-12 Software Installation Procedure

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Automatic biochemistry analyzer BK-200 user manual

Step 6: Confirm the installation, click “Next” to install, the installation process shown
in Figure 2-14

Figure 2-13 Software Installation Procedure Figure 2-14 Software Installation Procedure
Step 7: Installation is complete, as shown in Figure 2-15, click "Close" button, close
the form.

Figure 2-15 Software Installation Procedure


Step 8: replace the config.ini after the installation is complete. First find and copy the
config.ini file on the installation CD in the file, as shown in Figure 2-16:

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-16 Software Installation Procedure


Open the installation directory D: \ Program Files \ BIOBASE BK-200 and paste, as
shown in Figure 2-17:

Figure 2-17 Software Installation Procedure


Step 9: The software installation is complete.
2.4.3 USB driver installation
Driver should be installed after USB data cable connected to the machine. Whether
the installation is successful or not, you can follow the steps below:
Step 1: Right-click “computer (My Computer)” - Select "Manage" - Select "Device
Manager" in the management - open the "Port (COM and LPT)", as shown in the
following illustration:

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-18 USB driver installation procedure


Step 2: Successful displayed is as shown in Figure 2-19. The unsuccessful drive
installation is shown in Figure 2-20.

Figure 2-19 USB driver installation procedure

Figure 2-20 USB driver installation procedure


1. One Click Installation
To drive One Click Installation, find "CP2104" driver files in the installation CD, run
"CP210xVCPInstaller.exe". As shown below:

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-21 USB driver installation procedure


2. Install manually
If One Click Installation is not successful, manual installation should be operated.
Manual installation steps are as follows:
Step 1: In the Device Manager, right-click the drive device

Figure 2-22 Install manually


Step 2: Select and Update Driver Software, open the following interface:

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-23 Install manually


Step 3: Select "Browse the computer to find the driver software", open the sub-
interface as shown below:

Figure 2-24 Install manually

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Automatic biochemistry analyzer BK-200 user manual

Step 4: Select "Select from computer’s driver list" and click "Next" to open the sub-
interface as follows:

Figure 2-25 Install manually


Note: To start the installation, it is needed to select the port model in the list, and then
proceed as follows.
Step 5: Click the "Install from disk" button, open the sub-interface as below:

Step 6: Click the "Browse" button and then select the CD-ROM drive to find
“ ”, open the folder and select driver file slabvcp.inf, as shown in
Figure 2-26:

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-26 Install manually


Step 7: Click the Open button, as shown in Figure 2-27, which is selected driver:

Figure 2-27 Install manually


Step 8: Click the OK button in the interface, as shown below:

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-28 Install manually


Step 9: Follow the tips to click "Next" to install until the installation is complete.
Step 10: After the installation finished, select the Properties button in the Device
Manager, as shown in Figure 2-29:

Figure 2-29 Install manually


Select Power Management in the Properties dialog, and delete the check mark of
“Allow the computer to turn off this device to save power”, as shown in Figure 2-30:

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Automatic biochemistry analyzer BK-200 user manual

Figure 2-30 Install manually


Note: This setting should be set every time when the USB cable is plugged or
unplugged.
Step 11: After the driver and software installation are successful, change the [COM]
field in the config file to the COM port of the software application, as shown in
Figure 2-31. Refer to step 10 for the specific COM port view method.

Figure 2-31 Install manually

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Automatic biochemistry analyzer BK-200 user manual

2.4.4 Software Uninstallation


To uninstall the installation program, click Control Panel -> Programs and Features ->
Uninstall the program, locate the BIOBASE BK-200 or click the "Start" menu, select
"All Programs", select the folder of BIOBASE BK-200, uninstall BIOBASE BK-200,
which can complete the uninstallation of the program, as shown below:

Figure 2-32 Software Uninstallation


After the software is uninstalled, the default database is retained. If you want to
upgrade the software version, after the software is uninstalled, install the software in
the original software path, and retain the original data.
2.4.5 Printer installation and inspection
Before using the operating software for printing, please check the following
information:
(1) Check whether the printer driver is installed or not;
(2) Check whether the data cable between biochemical analyzer and printer is correct
or not;
(3) Make sure that the printer has been installed with the specific paper, you can print
after opening the printer switch.
2.4.6 Scanner installation
BIOBASE series automatic biochemical analyzer operating software is divided into
two types of closed and open. Please check whether the machine number contains a
“T”. If the end of machine number is "T", then the operating software is closed, which
need to install the scanner; if no the letter “t”, then the operating software is open, do
not need to install the scanner.
2.4.7 First boot
After installation, turn on the following power:
Power supply, computer power supply, computer display supply, printer power, open
the master switch (on the rear board of machine), the instrument master and the
cooling switch (on the left board of machine).
The instrument operations are as follows:
1. the mixing arm lift, cleaning arm lift;
2. stir moving from side to side, and back to the cleaning position;

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Automatic biochemistry analyzer BK-200 user manual

3. the reaction plate turn to zero;


4. repeat steps 1, 2 again;
5. the sample arm lift, moving from side to side;
6. reagent sample plate turn to zero, then clockwise rotation;
7. repeat step 5, 6 again, then the instrument into the standby state.
Note: when the various positions are not in the zero position with the instrument in
the standby state, it needs to enter the software and click on the initialization
command to perform an initialization operation. Then they will performed!
After about 20 minutes of power on (wait for temperature and light source is stable),
the instrument can be tested.

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Chapter 3 Software Operation


3.1 Software Operation

Run the desktop icon , When you run the software for the first time, it will tip
On line setup, as shown in Figure 3-1. Click "OK", the dialog box shown in Figure 3-
2 will pop up and then click the software configuration. If the following figure 3-3
dialog box appears, the software configuration is successful.

Figure 3-1 Software Operation Figure 3-2 Software Operation

Figure 3-3 Software Operation

Run the desktop icon again, open the software, enter the login interface, as
shown in Figure 3-4, input the initial user name: 1000, the initial password: 1000,
click the button and the software opens.

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Automatic biochemistry analyzer BK-200 user manual

Figure 3-4 Login information interface


After the connection is successful, a dialog box whether it is necessary for exhaust
operation or not will pop up, as shown in Figure 3-5.

Figure 3-5 Login information interface


Click "OK"and enter the main interface, first is the instrument initialized operation.
After the initial operation completed, run three times exhaust operations; when the
exhaust operation is completed, the instrument enters standby state. If you choose
"Cancel", the software will directly into the main interface, and the instrument into
the standby state. The main interface of the software is shown in Figure 3-6.

Figure 3-6 Software Main Interface


3.1.2 Language Selection
The software language can selected based on operator’s requirements: English or
Chinese. The steps are as follows:

Language selection: Find the file in the installation file directory,


change the "[Language]" in the file to "zh", the software interface is Chinese; and

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Automatic biochemistry analyzer BK-200 user manual

change to "en", the software interface is English. Click "File / Save" is ok, as shown
in Figure 3-7.

Figure 3-7 Language Selection


Run the main program, if the dialog box shown in Figure 3-8 pops up, it dues to that
the language file is missing or "[Language]" item was modified incorrectly.

Figure 3-8 Language selection faulty alarm

Then it needs to examine the Language files or existence


in the installation folder, or check the modified content is correct or not in the

"[Language]" of document.

Figure 3-9 Language faulty alarm

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3.2 Software Interface


3.2.1 Software Composition

Software interface consists of several major parts:

the menu bar, toolbar, workspace, the status bar ,as shown in 3-10

Figure 3-10 Software Composition


1) Menu bar
Menu Bar: Displays the function menu of the instrument software. Click the menu bar
to display the submenu, Click the submenu to display the software operation interface
The menu bar is located on the left side of the main interface, display the function
menu for the operation of the software, the menu bar icons and functions are shown in
Table 3-1.
Table 3-1 Menu bar icons and functions

No. Icon Function


Input the sample information and calibration and quality
1
control.
Edit project parameters, edit calibration, quality control
2
parameters.
Edit the position information of the reagent so that it
3
corresponds to the reagent position.
Test curve, test result query, quality control result query,
4
report printing, data maintenance and export.

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Instrument detection, instrument calibration, absorbance test,


5 cleaning the reaction cuvette and read background
information.
For data statistics, user management settings, version
6
information query.
Monitoring the sample plate, the reagent plate and the reaction
7
plate during the test.

8 Exit the software

2) Status Bar
Located in the top right of the main interface,real-time display the current user,
display computer system time, as well as current working state or testing process.

Display as shown in figure 3-11:

Figure 3-11 Status Bar

: Display the current operator's name, the user can be added and
deleted in “User setting”.

: Display the current computer system time.


: Show the current working status of biochemistry analyzer.

3)Tool bar

Located in the main interface of the upper left, several commonly used functions of
the software are placed in the toolbar. It is convenient to user for corresponding
operation, as shown in figure 3-12, selected by mouse click.

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Start Stop Initialization Online Alarm Temperature


Figure 3-12 Tool bar
4) Workspace
According to user's choice, it can appear the corresponding functions in the interface
window. Such as in the menu bar, click on the "project input" button, the display as
shown in figure 3-13"sample input software interface.

Figure 3-13 Sample test

5)Version information

Software version shows in the status bar,as figure 3-14 shown.the way

of viewing the hypogynous machine version:click ,workspace

shows the User setting interface,click button,as figure 3.14

shown;click To get the corresponding driver board version

number,click to get the machine number and the version number

of the hypogynous machine.

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Figure 3-14 Version information

3.2.2 Keyboard function


(a) Number Lock (Num Lock)
This key can determine whether to open the numeric keypad or not.
(b) the Caps Lock key (Caps Lock)
This key is used to switch the capitalization of letters.
3.2.3 Software Function Chart

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Figure 3-15 Software Function Chart


3.3 Software Operation
Choose software operation by the way of mouse clicking. Input number, word by
the use of keyboard (Input method according to Windows system,can transform by
Shift+Ctrl button).

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3.3.1 Movement method of the cursor


Click the input area or item,cursor will move.
3.3.2 Choosing method of button
Choosing the needed button by mouse click.
3.3.3 Forms Open
Forms are divided into 2 kinds: model form and modeless forms.
Modal form: Other form cannot be operate before close the form.As shown in figure 3

-16:

Figure 3-16 warning message


To close, click the "Close" or " " button.

Non-modal forms:After this form is opened, other forms can also be operated. As

shown in Figure 3-17:

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Figure 3-17 Reagents information


3.3.4 Operation of list box and the scroll bar
(a) List box
A frame that displays a portion of many of the information is called a list box. You
can find and choose the information you need,As shown in Figure 3-18:

Figure 3-18 List box


(b) Scroll bar
Scroll bar is used to adjust the scope of the display list box.Scroll bars are usually
divided into vertical scroll bar (located at the right end of the list box) and the
horizontal scroll bar (located at the lower end of the list box)
Check the content of the list box, click “ ” or hold the cursor “ ”with the mouse
drag to move.
Click“ ” to open or close drop-down list box can display more information.

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3.3.5 Radio box and check boxes

Radio box:Choosing only one function among several functions, as shown in Figure

3-19:

Figure 3-19 Radio box


check boxes: Choosing two or more functions at the same time. As shown in Figure 3
-20:

Figure 3-20 Check boxes

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Chapter 4 Testing Process


4.1 Equipment Standard
Refer to Table 1-1 for the standard specifications of the instrument.
4.2.1 Test Procedure

Figure 4-1 Test Procedure


4.2.2 Clean probe action sequence

Figure 4-2 Clean probe


There are five cleaning probes, including the top three probes are double probe,
probe A is responsible for water, probe B is responsible for pumping, the following
two probes only B, responsible for pumping.
The washing step of a cuvettes is:
Reaction wheel turned to the position,cleaning arm vertically downward,cleaning
probe B to draw dry cuvettes, cleaning probe A add water, two probe work at the same
time when cleaning arm rise,the cleaning arm stops for a short period at the top of
the cuvettes and in the meantime the probe A and B stops working, the cleaning arm
back to its original position;
4.2.3 Optical measurement operation sequence

This instrument uses the whole journey mode,when the reaction disk is rotated, the

absorbance of the pure water and the reaction solution in the cuvettes is determined
continuous.

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The reaction disk rotates in 1 laps for about 18 seconds, and the absorbance value is
measured by the 120 cuvettes when the optical axis of a spectrophotometer is passed.
36 times (36 metering points) were determined for each cuvettes.
Light emitted from the light source is focused by a lens, first pass the cuvettes, then to
the photoelectric receiver transformed into electrical signals. After the two-stage
amplification and Log conversion obtained after the absorbance or absorbance rate of

change,Can be used single / dual wavelength test.

4.2.4 Reagent cooling system


(1) Composition and function
Cooling system is the reagent preservation system
(2) Specifications
Cooling temperature: 2℃ --8℃
Note 1: When the main power supply access, the analysis of the power supply and
cooling system power respectively through the independent switch control, Even
though the analysis department does not work, the cooling system can also be in the
working state.
Note 2: The use, storage and disposal of reagents should be carried out in strict
accordance with the instruction manual.

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Chapter 5 Instrument Operation Principle


The principle of the instrument includes the action principle and the method of
analysis. As follows:
5.1 Initialization Principle
The mechanical part of the automatic biochemical analyzer is composed of sample
tray, sample filling mechanism, reagent plate, reagent filling mechanism, reaction
plate, stirring mechanism, cleaning mechanism and optical road system
After the instrument analysis department is started, the instrument will be reset
first,details initialization action as follows:
1. Mixing arm rising, cleaning arm rising;
2. Mixing arm swing then back to the cleaning position;
3. Sample tray initialization;
4. Repeat one time of step 1, 2;
5. Sample arm rising, then swing;
6. Reagent& sample tray initialization then clockwise rotation;
7. Repeat one time of step 5,6 then machine into standby mode
Attention: After the machine electricity and into the standby mode, each position is
not at the initial position, you should entry the software and click initialization, then
can be corresponding to the initial position.
5.1.1 Action Position
The relative position of the probe and cuvette is: sample probe 1 position, mixing
needle 105 position, cleaning needle 75 positions.
5.1.2 Analysis Process
Instrument analysis process shows on the figure 4-1
5.1.3 Optical Characteristics
The instrument uses the entire metering mode. During reaction process, the machine
will continuously measure the absorbance of pure water and the reaction liquid within
the cuvette. It takes about 18 seconds reaction rotate 1 circle. When 120 cuvettes
passing through the optical axis of the photometer, absorbance values are measured
individually. Each cuvette in the reaction time is measured 36 times (36 metering
points).Light emitted from the light focused by a lens, go through the cuvette first,
then though the photoelectric receiver transformed into electrical signals, for
secondary amplification, after Log conversion rate determined absorbance or
absorbance change.

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5.2 Analysis Method


Biochemical analyzer is based on the material selective absorption of light, analysis
methods that established on Lambert - Beer law.
Its detection principle is: a specific wavelength of monochromatic light through a
cuvette containing sample solution, it is proportional that intensity of monochromatic
light is absorbed (absorbance), concentration of the sample solution and distance
light pass through the solution(optical path).
1 I
A  lg( ) lg( 0 )  b c
This is: T It

Among them:

A - Absorbance is absorbed by solution


T - The Ratio of transmitted light intensity and incident light intensity,
transmittance
I0 - intensity of incident light;
It -intensity of transmitted light;
ε - Molar extinction coefficient (ml × mmol-1 × cm-1);
c - molar concentration of the solution (mmol / ml);
b - solution layer thickness (cm);
Solution layer thickness (b), that is, the optical path is fixed and known instrument.
Solution molar extinction coefficient (ε) is the wavelength, the solution and the
solution temperature correlation coefficient, when the guaranteed solution
temperature stability, in its single wavelength, the concentration of the solution and
absorbance has linear relationship ( ε is given directly in manufacturers reagent kit).
When the test sample is a homogeneous distribution of the solution, it was limited to
the role of incident monochromatic light absorption process, and fluorescence,
scattering and photochemical phenomenon does not occur, and in the absorption
process solution without interaction of each substance, each substance’s absorbance
having additivity, such systems comply with Lambert - Beer law.
5.2.1 Analysis Types
Please refer to the specification of the requirements set reagent chemical parameters.
Note 1: When the equipment measuring, the reaction solution volume range should
be 120-450ul.
Note 2: For reading point is not used, be sure to enter "0."

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(1) One endpoint


After adding samples and reagents, absorbance was measured at a metering point
specified, the method to calculate the concentration of the sample that is one
endpoint method. Response curve shown in Figure 5-1:

Figure 5-1 Endpoint reaction curve

(a) Metering point:【L】-【M】-【0】-【0】(1<M<L≤42)

(b) Absorbance calculation:

Take the metering point L&M absorbance average, calculated is follow:

AL  AL 1  ...  AM 1  AM
AX 
(L  M )
(c) Concentration calculation
C X  {K  ( AX  A1 )} IFA  IFB

C is a sample concentration to be test, A1 is the first point absorbance value, K is K

factor,B is the absorbance of reagent blank,IFA and IFB is a constant of the

instrument, are represented by the slope and intercept

(d) Analysis Item:

Like TP、ALB etc.

(2)Two Point End


When analysis response has not yet started, select the first metering point, reached the
end of the reaction or equilibrium select the second metering point, the difference in

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absorbance between these two metering points are used to calculate sample
concentration, called 2 end-point, reaction curve shows below:

Figure 5-2 Two endpoint

(a) Metering points:

【L】-【M】-【0】-【0】(1<L<M≤49)

(b) Calculation of absorbance


Using M and N’s absorbance average minus L and H’s absorbance average, the
difference value is the absorbance, computational formula is below:
AM  AM 1  ... AN 1  AN A  AL 1  ...  AH 1  AH
AX  k L
(M  N ) (L  H )

Among them:
a
S   Rj
j 1
b
S   Ri
k= i 1

a:Determination of the number of AL reagent

b:measuring of the number of reagent Am

(c) Concentration Calculation


C X   K   AX  B   C1   IFA  IFB

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B is water blank, R1~R2 is add location of reagent、AX is the absorbance

difference value of L and M, CX is a sample concentration to be test, C1 is calibration

1(reagent blank) concentration、K is K factor、B is calibration 1(reagent blank)’s

absorbance. IFA, IFB is a constant of the instrument, are represented by the slope and
intercept.

(d) Analysis Item:

Like CRE etc.


(3) Fixed Time Method
Measuring two metering point, neither the two points is the the initial reaction
absorbance nor the end point absorbance, calculates the difference between two
absorbance in the unit used to calculate the concentration of the sample, it called 2
point rate/fixed time, reaction curve shows as 5-3:

Figure 5-3 Fixed Time

(a)Metering points:

【L】-【M】-【0】-【0】(1<L<M≤49)

(b)Calculation of absorbance
The metering points M and M-1 absorbance metering point average and the average
of L and L-1 absorbance subtraction, the difference divided by the time as absorbance,
is calculated as follows:

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 AM  AM 1    AL  AL 1 
AX  2 2
t

Among them:

t :Interval of L and M metering points (minutes)

(c) Calculation of Concentration


C X   K   AX  B   C 1  IFA  IFB

B is cup blank,R1~R2 is add position of reagent, AX is the average metering point

between L and M change in absorbance per minute, CX is sample concentration to be

test,C1is the concentrations of calibration solution 1 (reagent blank), K is K factor,

B is the calibration solution 1 (reagent blank) absorbance, IFA and IFB is a constant
of the instrument, are represented by the slope and intercept.

(d) Analysis Item:

BUN、Picric acid method CRE, etc

(4) Rate Method


Measuring method according to the rate of change in absorbance per minute to
calculate the concentration or activity values between the two metering points, known
as rate A method, the reaction curve shows below:

Figure 5-4 Rate Method

(a) Metering point::

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【L】-【M】-【0】-【0】(1<L<M≤49、 L+2<M)

(b) Calculation of absorbance


Get metering point L, the rate of change in absorbance per minute between M by the
least squares method.

AX=△A(M-L)

(c) Concentration calculation


C X   K   AX  B   C1   IFA  IFB

B is water blank, R1~R4 is additional reagent position,△A(M-L) is the average

metering point between L and M change in absorbance per minute, CX is sample


concentration to be test, C1 is the concentrations of calibration solution 1 (reagent
blank). K is K factor, B is calibration fluid 1(reagent blank) change in absorbance per

minute. IFA、IFB is a constant of the instrument, are represented by the slope and

intercept.
5.2.2 Calibration Method
(1) One point linear method (K factor method)
Though measuring the calibration solution 1’s absorbance and input K factor to get
working curve, shows as below:

Figure 5-5 One point linear calibration curve (K factor method)

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(a)"Calibration Parameter" Input


Calibration type: [1 point linear]
Calibration point: [1] (the number of calibration fluid)
Range point: [0]
(b) Confirm the K factor
Enter the K factor in the Calibration Result form.
(c) Calculation of working curve parameters
B(S1ABS): the absorbance of the calibration solution 1 or the rate of change in
absorbance per minute.
K: input value
C1: the concentration of the calibration solution 1 is the input value.
(d) Calculation of Concentration
C X   K   AX  B   C 1  IFA  IFB

Cx is a sample concentration to be test, Ax is the sample absorbance or absorbance


change per minute, IFA and IFB is the instrument constant, are represented by the
slope and intercept.
(e) Applicable analysis methods
One endpoint method, Fixed time method, Two endpoint method, Rate method.
(2)Two point linear method
Determination of the calibration liquid 1 and calibration liquid 2, formation of a linear
working curve, as shown in figure 5-6

Figure 5-6 Two point linear calibration curve


(a) “Calibration Parameter” Input

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Calibration type: [2 point linear]


Calibration point: [2] (the number of calibration fluid)
Range point: [2 ~ 6]
(b) Calculation of working curve parameters
B (S1ABS): Determination of the absorbance of the calibration solution 1 or the
change of absorbance per minute
K: the proportional constant of the linear working curve. The determination values of
the calibration solution 1 and the calibration solution 2 are calculated by the input
value.
C1 :Input calibration solution 1’s concentration

C2 :Input calibration solution 2’s concentration

A2 :The absorbance of the calibration solution 2 or the rate of change of absorbance

per minute of the calibration solution 2


(c) Calculation of Concentration
C X  K   AX  B   C1  IFA  IFB
Cx is the sample concentration to be test, Ax is the sample absorbance or absorbance
change per minute, IFA and IFB is the instrument constant, are represented by the
slope and intercept.
(d)Applicable Analysis Method
One endpoint method, fixed time method, two endpoint method, rate method.
(3)Multipoint linear method
By blank (or calibration solution 1) and calibration solution (second calibration
solution and sixth calibration solution) was determined by linear regression curve
made linear calibration curve shown in figure 5-7:

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Figure 5-7 Multipoint linear calibration curve(linear)


(a) “Calibration parameter” input
Calibration Type: [multi-linear]
Calibration points: [3-6] (Number of calibration solution)
Range point: [3-6]
(b) Calculation working curve parameters
B(S1ABS): Absorbance or rate of change in absorbance of the calibration liquid 1 per
minute, the intercept of a linear regression equation.
K:Reciprocal of linear regression curve slope

The formula of S1ABS ( B) and K


X  Cr
A
S1ABS ( B) = Y
Y
K
X

 Cri  
n
 Cr  Ai  A
X: i 1

 Cri  Cr 
n
2

Y: i 1

 n 
 n
 Cr :   Cri  / n
A :   Ai  / n  i 1 
 i 1 

A1, A2 is the two measured values of calibration solution (1), n is the number of
calibration solution N × 2, Cri is the concentration calibration solution (i) .
(c) Calculation of concentration

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C X   K   AX  B   C1   IFA  IFB

Cx is the sample concentration to be test, Ax is the sample absorbance or absorbance


change per minute, IFA and IFB is the instrument constant, are represented by the
slope and intercept.
(d) Applicable analysis method
One endpoint method, fixed time method, two endpoint method, rate method.

(4)Logit-log4P(nonlinear method)

Suitable for the working curve that absorbance showed convergence with the
concentration increase, Logit-log4P(Nonlinear method) calibration curve shown in
Figure 5-10: applies to the concentration increases with the absorbance showed a
smooth work curve, Logit-log4P(nonlinear method) Calibration curve shows as 5-8:

Figure 5-8 Logit-log4P calibration curve(nonlinear method)

(a)Entry of calibration parameter

Calibration Model:【Logit-log4P】

Calibration Point :【4~6】(Calibration fluid quantity)

Range Point :【0】Range calibration nullity.

(b)Calculation of curve parameter

B:the approximation of absorbance or the change when Cx approaching ∞ per

minute.

K:D-value of the absorbance of calibration fluid 1 or change rate minus B

a.b: Approximation of coefficient, calculate automatically.

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S1ABS, K, a, b displayed in the calibration result interface.

(c)calculation of concentration

C X  (C  C1 )  IFA  IFB
K
AX  B 
1  aC b

1  K  ( AX  B ) 
C b  
a  AX  B 

CX is concentration of testing sample, C1 is blank concentration. AX is absorbance of


sample of the change value per minute. K is approximation of coefficient. When CX

is closer to ∞, AX is closer to B. If K<0, AX≤B+K or K>0, AX≥B+K, C1=0,

IFA&IFB is coefficient of analyzer, which displays the slope and intercept.

(d)calculation of SD

N 2

  A  Ai , 
2
ij
i 1 j 1
SD 
2N  4

(N=4~6、j=1or2)

(Aij-Ai’) is d-value of absorbance between Ai’ from fitting equation and Aij from
testing or the d-value between Aij and A12. Every calibration fluid test twice, and the
maximum value of Aij is 12.

(e)Applicable methods

1point End, 2 points Rate, 2 points Ends, Rate A

(6)Logit-log5P(Nonlinear method)

Same characteristic with Logit-log4P, and Logit-log5p has one more calculate
parameter, so the result is more accuracy. Calibration is shown curve as Pic 5-9.

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Figure5-9 Logit-log5 P Calibration curve

( a )Entry of calibration parameter

Calibration Model: 【Logit-log5P】

Calibration Points: 【5~6】(Calibration fluid quantity)

Range point : 【0】Range calibration nullity.

(b)Calculation of curve parameter

B :the approximation of absorbance or the change when Cx approaching ∞ per

minute.

K、a、b、c:Approximation of coefficient, calculate automatically.

S1ABS、K、a、b、c displayed in the calibration result interface.

(c)Calculation of concentration

 AX  B 
a  b  lnC  c  C  ln  0
 K   AX  B  
Get C from Newton Approximation
C X  (C  C1)  IFA  IFB
K
AX  B 
1  exp   a  b  l n C  c  C 

CX is concentration of testing sample, C1 is blank concentration. AX is absorbance of


sample of the change value per minute. K is approximation of coefficient. When CX

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Automatic biochemistry analyzer BK-200 user manual

is closer to ∞, AX is closer to B. If K<0, AX≤B or K>0, AX≥B, so C=0,IFA&IFB

is coefficient of analyzer, which displays the slope and intercept.

(d)Calculation of SD

N 2

  A  Ai , 
2
ij
i 1 j 1
SD 
2N  5

(N=5~6、j=1or2)

(Aij-Ai’) is d-value of absorbance between Ai’ from fitting equation and Aij from
testing or the d-value between Aij and A12. Every calibration fluid test twice, and the
maximum value of AU is 12.

(e)Applicable methods

1 point End, 2 points Rate, 2 points Ends, Rate A

(6)Broken Line Method(Nonlinear Method)

Test from fluid1 to fluid 5 or fluid6, and get the curve line, and link those points with
straight line. As pic 5-10 shown.

Figure 5-10 Curve of broken line

(a)Entry calibration parameter

Calibration Model:【Broken Line Method】

Calibration Point:【5~6】(calibration fluid quantity)

Range Point :【0】range calibration nullity.

(b)Calculation of curve parameter

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S1ABS is average value of twice test for calibration fluid1 for absorbance or change
value of absorbance.
C2  C 1
K
A2  B
B: Absorbance or change rate of Calibration Fluid1.
A2: Absorbance or change rate of Calibration Fluid2.
C1: Concentration of Calibration Fluid1.
C2: Concentration of Calibration Fluid2.
Calculate K2, K3, K4,K5 with same method

(c)Calculation of concentration.

C X   K N  ( AX  AN )  C N   IFA  IFB

(d)Applicable methods

1 point End, 2 points Rate, 2 points Ends, Rate A

(7)Splines method(Nonlinear method)

In this line, every value of calibration linked to a complete curve, and the error is also
fitting in the curve, so the curve fitting is better than poly line. The calibration curve
is shown as pic 5-11.

Figure 5-11 Splines methods

(a)Entry calibration parameter

Calibration Model:【Splines method】

Calibration Point:【5~6】(calibration fluid quantity)

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Range Point :【0】range calibration nullity.

(b)Calculation of curve parameter

A(I)b(I)c(I)d(I): Approximation of coefficient, I=1~N.

Displayed in Calibration Result, S1ABS is a(I)(which displays intercept)

(c)Calculation of concentration
3
AX  a ( I )  b ( I )  C X  C ( I )  c (I)  C X  C ( I )2  d (I)  C X-C(I) 

f  (C X  C ( I ))  a  ( I )  b  ( I )  (C X  C ( I ))  d  ( I )  (C X  C ( I )) 2  d ( I )  (C X  C ( I )) 3  AX
Get C from Newton Approximation
C X  (C  C1)  IFA  IFB
CX is concentration of testing sample, C1 is blank concentration. C2~CN is
concentration of calibration fluid. AX is absorbance of sample or the change value per
minute. A2~AN is absorbance of calibration fluid or the change value per minute.
IFA&IFB is coefficient of analyzer, which displays the slope and intercept.

(d)Calculation of SD

N 2

  A  Ai , 
2
ij
i 1 j 1
SD 
2N  4

(N=5~6, j=1or2)

(Aij-Ai’) is d-value of absorbance between Ai’ from fitting equation and Aij from
testing or the d-value between Aij and A12. Every calibration fluid test twice, and the
maximum value of Aij is 12.

(e)Applicable methods

1 point End, Fixed-time, Rate, Turbidimetry.


5.2.3 Calibration Type
1. Water blank check
The water blank check is used to detect the absorbance after the purified water is
distributed to the cuvette.
Each cuvette used for testing should be tested for water blank. The results will be used
to correct differences among cuvettes. The test results will also be used to assess

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contamination of the cuvette.


2. Reagent blank testing
The reagent blank check is used to test the absorbance of the cuvette containing the
reagent. The reagent blank test value can be used to correct the absorbance of the
sample, resulting in more accurate test results.
3. Sample blank testing
The sample blank is the concentration of a sample used as a zero reference in a test
procedure. The sample blank can counteract the positive error caused by the color or
turbidity of the sample itself before the addition of the test reagent. Due to hemolysis,
lipidemia, jaundice, etc., the sample’s absorbance will affect the testing results. So,
measuring the absorbance of sample can remove the impacts. Measurement method is
based on the normal test reagents and sample size, changing the reagent into distilled
water or saline, and then testing.

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Chapter 6 Instrument Operation


6.1 Brief Operation
The brief sequence of operation is shown in Table 6-1, and the details in "6.2 detailed
operations."
Table 6-1 schematic instruments operation sequence table.
Procedure
Operation steps Operation
Form / key
- Before power must be checked
1. the pre-test check ——
before the test
Connect the external water input and
output devices to water purifier and
2. connect the water purifier
wastewater pipes, and turned on the
and power of automatic
Log analyzer power of pure water device and
biochemical analyzer
system analyzer
Biobase-Sapphire
Input operator's user name and
Login Software
password in the login form of the
system software
3. confirm the status of Check the light to confirm whether
instrument the measured value is within the
alarm
(1) Alarm confirmation allowable range
information
(2)confirm the light of Check the cup blank to confirm
system
photometer whether the measured value is within
maintenance
(3) confirm the cup blank the allowable range
Status Bar
(4) confirm the temperature To confirm whether the temperature
of the reaction vessel of the reaction tank is (37.0 ± 0.1) ℃
4. confirm the analysis
conditions
System add items
(1) Projects addition
Settings Confirm project parameters
(2) The logging and
Calibration Confirm the calibration curve and K
confirmation of chemical
information factor
parameters
(3) confirmed the value of K
5. Prepare reagent (reagent Reagent Confirm the residual reagent volume

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information) information and testing times of each items of


(1) confirm of the residual reagent
reagent volume Put the reagent that testing required o
(2) Colorimetric analysis the proper position
items
Calibration Confirm the project name required
6. set calibration and quality information calibration analysis
control items Quality Confirm the project name required
Control quality control tests
To carry out a single or batch of
routine sample registration and a
7. Sample registration and Sample
single emergency sample registration,
testing registration
patient information editing,
information modification and deletion
8. start testing
(1) preparation of sample, Put sample, calibration liquid and
calibration solution and Start quality control liquid on the sample
quality control solution condition plate.
(2) set of starting conditions Select test conditions, then perform
and send test instructions the "start test"

System
9. testing process
monitor
(1) system monitoring
Add pause / Test status of real time monitoring
(2) suspension and
continue instruments
continuation of adding
Emergency Edit the sample in the test process and
sample
stop click start testing.
(3) emergency stop
Sample
(4) additional sample
registration

Query, modify, delete, review and


10. confirmation of the
Testing result print the test results.
testing result (result data)
Sample response curve

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Confirm the condition for re-


11. Determination of re-
Testing result examining items in the form of “ addi
examining samples
ng the re-examine items”
Confirm, check and print the result of
12. The analysis finished
re-examining items.
(1) the result of the re
Regular database backup, suggest that
confirmation Testing result
the normal case of a week
(2) database backup system
Cut off the power supply for
(3) system shutdown management
instrument, computer and pure water
(4) cut off the power supply
device
(5) preparation before the
Clean up the equipment to prepare for
next work
next use
6.2 Detailed Operation
6.2.1 Inspection before test
The following tests should be performed before the test:
Check whether the power supply, the voltage is correct or not.
Check the communication lines and power lines between the equipment, the computer
and the printer to ensure that the connection is correct and there is no loosening.
Check the printing paper is sufficient, please install the printing paper if not.
Check the dispensing probe, reagent probe, the stirring rod and a cleaning mechanism
in front without adhesion of water droplets, no smudge or bending.
Check whether the water inlet pipe is under the level of the liquid, and the amount of
water is sufficient. If the device is directly connected to the water pipeline, then the
operation is not in use.
Check whether there is bubble in the syringe (the leakage and the bubble will cause
the data inaccurate).
Check whether the amount of cleaning fluid is sufficient, the reagent tray number 45
position need to be placed specific cleaning solution of BK series.

Warning:
The BK series of cleaning solution should be regarded as liquid corrosive liquid.
Once you hurt the skin or eyes, rinse with plenty of water.
6.2.2 Power on and Login
(a) Power on the automatic biochemical analyzer. The switch on the left side of the

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analysis apparatus is power switch, when a reagent on the reagent plate the switch
should be in the open state, to ensure the normal operation of the cooling system.
Switch on the right side of the equipment is power supply for analysis apparatus.
(b) Login biochemical analyzer application software, if you want to test, you should
first execute online instruction.
6.2.3 Light checking
(a) A/D Reading
In the light conditions, click the button in the menu button , after
entering the maintenance form, choose the "A/D reading" option in the maintenance
list, click "Y" button, the instrument will perform the inspection of light, the amount
of light with previous test results values are displayed in the result bar. As shown
below:

Figure 6-1 A/D readings


In the light case, adjust the instrument and amplifier voltage, A/D readings is about
50000, it is required that the range of delta OD is about ± 0.0015.
(b) Absorbance testing and instrument stability

Click on the menu bar button , open the "absorbance test" window,

covers the cuvettes with an opaque material, fix the reaction tank , click the
button, The instrument starts reading, reading completed, shows the cup number and
the corresponding absorbance values, you can use the scroll bar up and down on the
right data interface to choose to read all the cup data.

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Figure 6-2 Absorbance test


6.2.4 Confirm the temperature of the reaction tray

Click the software Toolbar " " menu, open the temperature display, observe the

temperature display in the status bar, confirm whether the temperature


in the reactor is (37 ± 0.1).
After power on, the temperature in the reaction tank is stable at (37 + 0.1)℃, which
takes about 20 minutes. The stability of light source also takes a few minutes, so after
turning on the instrument, can perform information browsing, item parameter input,
alarm information, view, etc. , you can test sample until the temperature is stable.
6.2.5 Confirm analysis condition
Before the test, adding the analysis of the project first, and then assure the project
parameters, calibration parameters and quality control parameters.
Analysis the parameter setting, using methods, precautions and save of used reagents,
calibration liquid, quality control solution please refer to the instructions or to the
relevant manufacturers, vendors consulting.
6.2.5.1 Confirm the parameter of items

In the menu bar button, click the , enter the interface of the items
parameter, to determine the items parameter, as shown in figure 6-3.

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Figure 6-3: Project parameters interface


According to the specifications of the reagent, the parameters of the reagent are set up
or confirmed. Some of the parameters for the test is indispensable, such as: test
project name, analysis method, Main\auxiliary reading point, main\sub wavelength,
sample size, reagent size. Although some parameters have no effect on the test results,
has important significance for evaluating the reliability of test results, such as the
normal range, the absorbance limit. Operator should input the correct parameters one
by one before the test.
6.2.5.2 Portfolio project settings
The portfolio project, is the combination of related project together, such as liver
function, renal function, a full set of complete set, just click on the name of portfolio
project can complete a project registration function, convenient and fast input samples
at the time of registration.
Click the “special items” button in the toolbar to enter the "special item parameter
settings" form and then click the "add" option on the right combination item, add the
relative item according to the requirement.
Figure 6-4: first click on the increase, according to the serial number to fill in the
project number, according to the user`s need to fill out the "project", referred to as the

"Chinese name", "name English", and according to the requirement click “ ”

add to the “optional items list", click" "to cancel relative item operation, then
click" save "to complete the operation.

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Figure 6-4 combination project

6.2.5.3 Settings of the calculating items


Calculation of the project is the use of A, B two items or more of the results of the
project, to calculate the results of another new project.
Click the Toolbar "special projects", enter the set special item parameter form, click
on the lower left side of the "combo box". The "increase" button is configured
according to user needs.
As shown in Figure 6-5, click the "add", fill out the "item number" according to the
serial number, according to the user needs to fill out the "project" Chinese, referred to
as "full name", "name English", according to the need to add the project instructions
to fill in the "unit of measurement" and "normal value", "low normal value" and "the
number of decimal places" and "formula", after completing click to save.

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Figure 6-5 Computing project.

6.2.6 Preparation of reagent (reagent information)


6.2.6.1 Use and precautions of reagent
(a) Preparation, use and storage of reagents must be strictly followed the instructions
of the reagents, the reagent is not allowed to have bubbles. As the reagent containing
surface active agent, shaking will produce bubbles in the process of testing. If the
reagent probe meet the bubble it will mistakenly judge that it has come into contact
with the reagent, resulting in reagent consumption inaccurate, affecting the test results.
(b) Absolutely do not add reagent.
If you add different manufacturers or different batches of reagents in the reagent, you
will change the composition of the reagent, so that the test results are inaccurate.
6.2.6.2 Reagent Login
BIOBASE series automatic biochemical analyzer operating software is divided into
closed and open system, the two ways of reagent information logging are bar code
scanning and manual entry.
(a) input closed software reagent information

Click the menu bar " "show "reagent information" operating interface, as
shown in Figure 6-6, scan the code with a sweep code reader barcode according to the
reagent panel .

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Figure 6-6 Reagent information (close-system)


If the reagent input is wrong, you can click "removed" key, delete the item to rescan.
(b) input reagent information in the opened software

Click the menu bar " software show " reagent information" interface, as
shown in Figure 6-7, Query reagent project according to the order of reagent disc ,
and select the type of reagent packaging specifications and click Modify, then you can
input.

Figure 6-7 Reagent Information (open-system)

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Warn: No. 28 of reagent plate only can put BIOBASE series machine special
cleaning fluid.
6.2.6.3 Residual amount of reagent

In the "reagent information" form, click the " " key, the instrument
automatic detection reagent remaining amount, the remaining test number, the results
of the test information is displayed in the "reagent information" list box.

Figure 6-8 Interface of reagent detect number


During the testing process, as long as the reagent is used to absorb the reagent, the
residual amount of the reagent is detected, and the remaining amount of the reagent
and the remaining test number are updated.
6.2.7 Login Calibration

Click Software Menu Bar " ", " " is shown as in


Figure 6-9.
Set the calibration parameters according to the calibration instructions.
Click "Calibration Settings" button, following calibration instructions to modify the
"standard number", "concentration" option, modify “Cup No.” according to the
position where the calibrators placed in, "repetitions" according to the requirement,
after finished setting, click "edit" and then click "save".

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Figure 6-9 Calibration parameters


The difference of calibration type see table 6-2 :
Table 6-2 calibration method

Calibration type calibration fluid quantity The sample application

Factor — CK-MB

Single standard 1 calibration solution GLU,TP,ALB

1 calibration liquid, water


Double standard TBIL,DBIL
blank

Multi-point standard 3~6 calibration fluid —

Logit-Log 4P 4~6 calibration fluid ApoA1,ApoB

Logit-Log 5P 5~6 calibration fluid C3,IgA,IgG,IgM

spline 5~6 calibration fluid C4

Broken line 5~6 calibration fluid AFP,CRP

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6.2.8 Login Quality control

Click the menu bar " " software "calibration" interface, click on the lower

right side of the window, select " " , show “control parameter
"interface, as shown in figure 6-10.

Figure6-10 Quality control parameters A

The steps of adding new project quality control: first in the "quality control

parameters" click " " button, according to the quality manual batch fill in
"batch", as shown in Figure 6-11, choose the items need quality control and then click

to select, after selecting and then click" ".

Figure 6-11 quality control parameters B

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After the preservation, the quality control parameters interface will be shown as figure
6-12.

Figure 6-12 Quality control parameters C


For example: select the newly added quality control 766, on the right side there items
need quality control, according to the quality control 766 to add the "target" and
"standard deviation", after modify and close the window, the operation is completed.
6.2.9 Sample Input and Testing
(a) add ordinary items

Click the " " button in the toolbar, enter the "entry" form, as shown in
the figure below:

Figure 6-13 Project entry

Single sample entry: click , and choose test items in the left column,

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click " " to move test item to “selected test items "column, the sample number is
generally from the beginning of 1, followed by accumulation, a number can not be
repeated, and then fill in the information of patients" name "," gender "," age ", Edit
“inspection department "and" sample type "," submission of doctors' information,

when completed, click to complete the operation.


Batch sample login: if there is more than one sample to test in the same project you
can use the “batch input”, placing the sample on the sample tray continuously, click

the fill in the quantity and starting position number that to be tested,
sample position number imputing is from1 to 60, from 60 on, sample position number
plus 1, increasing gradually start from 1, save the selected items to be tested, complete
the operation.
Project portfolio login: if in the process of sample inputting, the project selected is the
combination that has been set up, you can directly select in the combination bar that

in the left side of interface, click directly add to the “selected project
determination "column.
You can edit the information you have input. In the landing list column, you can
choose one sample number to choose, which display the patient information and

testing items information, press" " or " " button, to edit, delete

the contents, after modified click " " to confirm.


(b) Preparation before testing
Preparation of cleaning liquid, calibration liquid, quality control solution and sample:
The calibration liquid, quality control liquid, sample and cleaning liquid used in the
analysis, which are placed in the corresponding position of the sample plate.
Cleaning fluid: the cleaning liquid of BK series fully automatic biochemistry analyzer
is generally placed in the reagent position of 28.
Standard solution, quality control liquid: standard solution and quality control liquid
are set according to the calibration, quality control setting.
Sample: sample placed according to the number of landing position.
(C) Testing procedure
Sample landing completed, the temperature is stable, the other testing conditions are

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set finished, click the start button , will pop up the dialogue as shown in the
Figure 6-14, choose “cleaning solution”, automatically adding cleaning solution to
reaction cuvette and cleaning the used reaction cuvette. Click “Start”, enter the
process of sample testing.

Figure 6-14 Choose cleaning fluid


During the test, the status of the sample testing is displayed in the status bar, as shown
in Figure 6-15a.

During the sample testing, click on the menu bar to perform real-time
monitoring of the instrument sample tray, reagent tray, reaction tray status, as shown
in Figure 6-15 b).

A) Sample test status

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b) Status Monitor
Figure 6-15 Sample Test
Sample tray monitoring: click “sample trays status” under the “monitor” form, as
shown in Figure 6-16, wherein the sample tray with different colors to distinguish the
status of samples.
Reagent tray monitoring: click the “reagent tray status” in the "monitor" form,
respectively, the reagent plate test status will display in the left of the form, as shown
in figure 6-17:

Figure 6-16 sample plate of monitoring Figure 6-17 reagent disk monitoring
Reagent disk by serial number indicates that the reagent placed number, when the
instrument starts testing, reagent probe after taking the reagent, the software will
automatically calculate the residual of the reagent, and the reagent information

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displayed on the inside. In the reagent tray: white indicates empty yellow indicates
less reagent, green indicates that the reagent sufficient, Red means no reagent.
The reaction disk detection: The reaction disk in real time display the status of the
reaction at the time of sample testing. As shown in Figure 6-18, where in the different
colors represent the cuvette in different working conditions.

Figure 6-18 reaction monitoring


(d) Test pause, continue and terminate

Sample test in progress, click push button in the editor toolbar “ ”, “ ”or

“ ”, achieve the control in the testing process.

Click " " to temporarily stop the test process, click ' ' to continue testing, click

the " " emergently stop test state.


(e) Additional samples
During the test, if there is need for adding samples, you can click on the "sample
login" according to the requirement to add the sample to be tested.

6.2.10 Test result Query


The testing results will be displayed in the "Data Processing" column, the testing
results can be queried in the "Print Report" or "Test Result Correction", as shown in
Figure 6-19:

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Figure 6- 19 Print

As shown in the figure, directly select the date, in the "Print Report" ,you can query

the historical test results.


In "User Setting", you can use "date" function to make a statistical query for the

historical test data. Query process, choose the corresponding date in the “date”,then

,click "Statistics" , get the test result.

Data statistics include test statistics, workload statistics and cost statistics, as shown
below.

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A) Test Statistics

B ) Workload Statistics

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C ) Expensive statistics

Figure: 6 – 20 Test statistics

6.2.11 Sample Retest


After we have get the test result , If there are some data, which are deviated from the
normal value, this items need be retested. At the “Sample Input” interface, select the

“retest”.
In this interface, choose the retest items , firstly, click 'Edit' to select the re-testing
items, then, Click "Save" to complete the retest item input. If the sample are testing,
the retest items will be tested automatically. If the machine is not run, find the
“sample test” , restart the test task.

NOTE : Only the test data of the today , which can be re-tested

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Figure 6 -21 Input sample of retest


6.2.11 Operation after test
Test finished, if there are no objection for the data, select "Washing and background"
in the menu bar "Maintenance", and in the "Washing and background" interface ,
select "Cleaning" function, after cleaning ,close biochemical analyzer power. Unused
biochemical reagents needed be save, remove the extra reagent and use reagent bottle
caps cover it , then put it into the medical refrigerator . Remove the already tested
sample, calibration and control solution where in the sample tray. If you use waste
container, dispose of the liquid in a safety way. Detecting the equipment table is dirty
or not, and clean the table.
Chapter 7 Calibration and Quality Control

In software interface, click the , then, click the “ CalibrationPar ”, you can
check the calibration parameter, and change the calibration parameter.
7.1 Calibration
7.1.1 Calibration Parameters Settings
Click “ Item Setting”, then click the “CalibrationPar” , input the calibrator parameters.

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Figure : 7-1 calibration parameter

After we finished the input reagents parameters, in this interface, select test items

which need be calibration. Then click on the right “ ”. After input the
correct parameters, in "Calibration type", "Standard counts", "Repeat counts",
"Sample type", "Concentration", "Cup No.", finally click "Save". "Concentration" and
"Cup No" , need according to the calibrator and the calibrators location number in
reagents tray , then click 'Edit'.
7.1.2 Calibration test
In the “ Program Input” interface, click the “ Calibration & QC Input ”, and select the

need calibrator test items, click the , then, click the “Save” , will get the a warn
and tell you “Save successful”, as the Figure 7-2 shown . After click the “ Sure” ,

you can click , start test。

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Figure : 7-2 Calibration test


In the calibration process, if an emergency situation happened , need to stop the test,

click on the button “ ” to stop the test operation.

7.1.3 Calibration test result Query


(a) Calibration curve
Click the Calibration, can query the curves. When the calibration test is finished, in
software interface, click the “ Data Processing” , then, click the “ Curve ”, As the
Picture 7-3 .

Figure : 7-3 Reaction Curve

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In Curves interface, at “Test Date”, select the calibration date and the need queried
items. Then, we can get the calibration curve.

( b) Calibration result
Under “Item setting” interface , click " CalibrationPar " interface , Directly select the
test items result that you need to view, as shown in Figure 7-4.

Figure 7-4 Check result of calibration

As shown in Figure 7-4, in " CalibrationPar " interface , firstly, in the "item list"
select the items name that you want to view, then, in this interface, select the Date,
you query the calibration result.

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7.2 Quality Control


7.2.1 QC setting ( See Section 6.2.8 )
7.2.2 QC test
After quality control information registration is complete, on the main interface, click

, access operation interface ,on the right side of the work


area, click "add", batch number of the quality control solution is selected in the "quality control lot
number", input the control liquid number in sample tray in QC position No, from the middle list
need to quality control of the project to the "quality project", quality control list shows the number
of editing quality control tests, after the completion of the editor, click "save", as shown in figure
7-5.

Figure 7-5 QCInput


7.2.3 Quality Control query
(a ) QC Curves
The query method is the same as the 7.1.3 calibration curve
(b ) QC test result

In the original window, click the “ Data Processing” , then, click the “QC
results query", firstly select the QC items and “ QC Lot No” , According the “Test
Date”, we can get the QC Control result.

And, if you want get the trend of every time test result, Can select the “ Sandard QC
Chart” “Relative QC Chart” “ Display QC Value”

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Figure 7–6 Check result of QC


7.3 Factor correction
The calibration quality control test is completed, the query results of quality control in
the quality control target range, then the scaling factor can be directly used for sample
testing; if the quality control results of deviation from the target range, it is necessary
to control or modify the scaling factor of quality control.
The method of modifying factor is calculated according to the quality control value
and target value, and the formula is as follows:
formula :
New factor= (Old factor * quality control value) / Target value
After adjusting the factor, we must re - quality control, and determine the value of
quality control in the range of target value, to determine the correct adjustment of the
factor, in order to carry out the sample test.

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.7.4 Calibration and quality control flow chart

Figure 7-7 Calibration and quality control flow chart


Chapter 8 User Management and About
8.1 User Management
(a) User management
Click the “User management” , at there, can Add and Delete one new account,
Change User Password, As the Picture 8-1 .

Figure 8-1 User Setting


As shown in Figure 8-1, in the user code, user name, respectively, enter the
corresponding name, and select the user level, click "add" to increase a system user. If

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the advanced user login software, you can select a user left button, click "delete" to
delete the current user.
(B) Password Modify
Click the “Change User Password”, can change the being used account’s password,

Figure 8-2 Password Change

8.2 About
"About" is a software version of the introduction.

Figure 8-3 software version

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Chapter 9 Maintenance
9.1 Prepare before System Maintenance
To ensure the precision and accuracy of the fully automatic biochemistry analyzer, the
operator must obey “BK-200 Fully Automatic Biochemistry Analyzer User Manual”
for the operation and required maintenance. Thus the instrument will provide reliable
results and ensure longer service life of the instrument.
9.1.1 Required Tools
Before the system maintenance, please prepare below tools:
1. Tools in Accessory box

Screw driver…………………..(Used to open instrument cover plate)

Needle………………………..(Used for dredging dispensing needle)

Funnel……………………... (Used for adding coolant to the cooling system)

2. Users should prepare:

Clean cotton cloth…………………………(clean for machine)

Cotton swab………………………………….(used to clean dispensing probe, mixer,

cleaning probe)

Water tank (1unit)………………………(used to store waste)

Stainless steel wire(diameter 0.5mm)…(used for dredging the cleaning probe)

9.1.2 Purified water

In the daily operation and maintenance of the system, use deionized water, electrical

conductivity is less than 1 us/cm. When using pure water equipment, please do not
forget the regular maintenance and inspection of water purification equipment. Please
refer to the manual of the pure water device, or contact the manufacturer or distributor
of the water purifier.
9.1.3 Washing Solution
Washing solution is used for cleaning the equipment, should be provided by Biobase.
If replaced by other cleaning liquid, may cause a reaction cup, stir needle, needle,
needle cleaning and other cleaning is not clean, thus affecting the accuracy of test

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results and precision. Biobase is not responsible for inaccurate measurement of the
equipment not use Biobase washing solution.
The fully automatic biochemistry analyzer is mainly used alkaline cleaning liquid, the
designated position is the reagent position 28, for cleaning the reaction cup.
9.2 Software Maintenance
9.2.1 Initialization
Click the software Toolbar "initialization", the instrument automatically back to zero
position. In the reset process, do not allow emergency stop. Other operations can be
carried out after the initialization is completed.
Attn: When the instrument is powered into the standby state, each position is not in
the zero position, and it is necessary to enter the software click initialization
command to perform an initialization operation to return to zero!
9.2.2 Instrument Adjustment
9.2.2 .1 Position Adjustment
Sheet 9-1 Adjustment Position
Component Cleaning Reaction Sample Reagent Reagent
name position disk disk inner ring outer ring
plate
dispensing Cleaning 1 1 1 29
arm position
Stirring arm Cleaning 105 # # #
position
Cleaning Cleaning 75 # # #
arm position

Attn:

1, Vertical cleaning position of the dispensing probe: thinner part of the needle should
be completely in the cleaning cup. Dispensing probe vertical depth of reaction cup:
point of probe is 30 steps distance to the bottom of the reaction cup. Reagent depth is
20 steps distance to the bottom of the reagent bottle; Sample depth is 10 steps distance
to the bottom of sample cup.

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2, Cleaning position of the mixer should be enough deep but not touch the bottom of
the cleaning cup; Reaction position of mixer should be 20 steps distance to the bottom
of the reaction cup.
3, Cleaning arm position adjustment should make sure all the probe except the one
with dry unit, just reach the bottom of the cuvettes; the last probe should 2mm lower
than other probes.
9.2.3 Optical System Maintenance
9.2.3 .1 Light Spot Inspection
To take away the cuvettes which block aperture in the reaction disk, use darker paper
block the light source, the light spot formed on paper. The paper moves back and
forth to see the brightest spot on the track cup campaign. Spot shape around a long
5mm, rectangular spot width of about 1.5mm, If there is a problem spot brightness,
check halogen installation location is correct (This position is generally not adjusted).
9.2.3 .2 AD Stability Adjustment
After adjust the AD board voltage. Click Software Toolbar "instrument check" button,
enter "instrument check" interface. If the optical system △ OD has larger changes,
Please adjust as follows:
(A) Check the lamp is uniform ,spot size is suitable.
(B) 12V input voltage is stable, if separate power supply or not.
(C) Grounding line is good; requirements to external and internal ground only on a
single-point ground power supply; external power supply on the ground must be
connected.
9.2.3.3 AD Absorbance Test
With an opaque material to cover a joint cuvette, place the opaque cuvette into
reaction disk.
Click on the software menu bar “maintenance”, Display "Absorbance Test" interface.
As shown in Figure 9-1:

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Figure 9-1 AD absorbance test


In the "Absorbance Test" screen, click "Test" button, the reaction disk rotates two
circles, read the absorbance of each cuvette. In the "wavelength" key, select different
wavelength and then view test results. The absorbance of the cuvettes covered with an
opaque material to meet the requirements of at around 5.
9.2.4 Thermostat System
Adopt direct air heating incubation, 37℃, maintenance free; no need extra
maintenance fees for incubation system.
9.2.5 Water System Maintenance

Figure 9-2 Cleaning probe


As shown in Figure 9-2, washing arm cleaning probe includes three injection pipe and
five suction pipe, 3 injection pipe corresponding solenoid valve V6, V5, V4, 5 suction
pipe respectively miniature diaphragm pump P7, P6, P5, P4, P3. Miniature diaphragm
pump P2 connect dispensing piston arm, Miniature diaphragm pumps P1 connect
clean probe injection pipe, dispensing probe cleaning cup and stirred probe cleaning
cup.

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L frame has four waterways adapter, two small linker is water inlet. The installation
of water pipes should be as short as possible, and install water fall head, Ensure the
machine waterway is normal.

Attention: When installation of water pipes make sure the smooth flow of
waste water outlet.
Each cleaning probe connected with a corresponding waterway through a
polyethylene tube.
When added head or pumping head is abnormal, sequentially check the pipe joints are
connected, solenoid valves and micro diaphragm pump.
9.3 Check before test
9.3.1 Power on Checking
When finished the installation of all parts and water system, please power on the
machine and check the conditions:

(1)Moving conditions of reaction tray, reagent &sample tray;

(2)Moving conditions of mechanical arms left & right& up & down;

(3)Working conditions of syringe pump, solenoid vale and diaphragm pump;

(4)Reagent &sample tray cooling condition, and if leak coolant.

As below figure 9-3 shows, power supply port includes USB power supply and three
pin power supply.

Figure 9-3 Instrument power supply port

Attn: before connect USB wire, please install USB device drive.

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9.3.2 Purified water, waste water and cooling alarm checking


If instrument is alarming when power on, please follow the alarm indicator and check
if waste water is full, less purified water or less coolant. Change waste container, add
coolant or adding purified water.
9.3.3 Pump Air Out

Open software, click , and then click button,

find “Water Pipe”,and click ,The piston of the pump is pulled up

and down again, and the air in the plunger pump and the pipeline is excluded.
During the air out procedure, do not suddenly stop. Execute other movements
when it finished.

Figure 9-4 Pipeline air out

Attn: After replacing piston pump or pipeline, execute air out procedure.
9.4 Software Problem
9.4.1 Printing Problem
9.4.1.1 change print paper type

Open the software installation folder, find “ ”and open it. Find [print
page], set the print paper type, A4, A5 and B6. For example the print paper type is

A5, .

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9.4.1.2 Edit Test Report


For example A5 paper. Open the sub folder ‘report’. Click A5.frx and drag it to
Designer.exe, when showing +, loosen the left mouse button. As shown in Figure 9-5:

Figure 9-5 Open Designer editor


Open the edit interface of test report, as shown in Figure 9-6

Figure 9-6 Edit test report


(a) Edit font size
Click the text content to be edited, find the properties on the right side and click it.
Find “Front” in the drop down list. As shown in the Figure 9-7: input “Size” number
to change.

Figure 9-7 Edit Font Size


(b) Edit text content
Double click the text content, for example double click “sample time”, will appear
Figure 9-8 interface: edit the text content in the interface and click ok to exist.

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Figure 9-8 Edit text content


(c) Print items height design
Find “configure Bands” in the left side, click Data: Customers card. Find “Height” in
the “Layout” in “properties” on the right side. Edit the value on the right side of
“Height” to “0.4cm”, to change the items height distance. Please see figure 9-9.

Figure 9-9 Print items Height setting


(d) Print content is not complete
Print content is not complete, the reason is margin distance too close to the bottom of
the paper. For example, “the print report does not display”. Please click any positions
of the middle of the paper, and move it to the bottom of the paper unit the small drop
down arrow appears, drag the mouse, until complete print. After settings, the text will
be like Figure 9-10.

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Figure 9-10 Print content is not complete

9.4.2 Closed Software can not be opened


If Biobase BK-200 appears below interface Figure 9-11, please use below “Repair
Tool” in the “bin” folder. The “Repair Tool” icon is shown as Figure 9-12.

Figure 9-11 Error Alarm Figure 9-12 Repair tool


Operation procedure as below: double click the repair tool, appear Figure 9-13
operation interface, chose “OK” button, appears figure 9-14 interface. Click confirm
to complete the repair. When finish repairing, will indicate that the repair is
completed, please re login the software.

Figure 9-13 Repair Figure 9-14 Confirm to modify


9.4.3 Mismatching of the software and the machine
Click login button, appears below interface, software and instrument not match.
Please click cancel to close the interface.

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Figure 9-15 Software and instrument not match

Click “login” button and at the same time press the “Ctrl” button. Enter software
operation interface. Click “Ctrl + Alt + R”, then click “ok” as figure 9-16 shows and
click “exit” button to exist the software.
Click login again. Appears figure 9-17interface. Click software configuration, appears
Figure 9-18 interface, that means the software configuration is successful.

Figure 9-16 system restore Figure 9-17 Online Configuration

Figure 9-18 configuration successfully


If not appear configuration successfully. Please release the compressed software in
the software CD. If still appears “no connection, please check the communication
line”, please check the hardware connection. If it’s ok, please check the
communication chip.

Attn: One computer can only control one biochemistry analyzer, if move

the Software to other computers, please contact our engineer.

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9.4.4 Database Operation Error


When the software show database operation failed, please use the database repair tool
“access repair wen test” as the Figure 9-19 shows, in the “bin” sub folder of the
software installation folder. Open this tool with double click, show the interface as

Figure 9-20,click the “Repair” button, waiting interface as Figure 9-21, finish

interface as Figure 9-22.

Figure 9-19 Repair Tool Figure 9-20 Loading database

Figure 9-21 Database being repaired Figure 9-22 Repair complete

9.4.5 Other problems


Bar code scan problem:
Some computer may no identify the scanner. For example, when you open the txt bar
code file and scan, the scanner only give alarm, but can’t scan any bar code. Please
change another bar code scanner that can match the computer.

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9.5 Equipment Maintenance


9.5.1 Regular clean, inspection and replace parts

Regular clean, check and replace part, please see sheet 9-2(Supposed using the

instrument 5 hours per day):

(○:Regular clean, inspection ●Regular replace, adding)

Sheet 9-2 Regular replacement of accessories


Period
Needs Yearly m Ever Ever
No Items for one consum dai timel wee on y3 y6 Year
time ption ly y kly thl mon mont ly
y ths hs
1 Sample cup ●
2 Dispensing probe ○
Cleaning cups of
3 dispensing probe ○
and mixer
4
cuvettes (20u 6 24
(Note ○ ●
nits/group) groups groups
a)

Reaction tray and


5 reaction tray ○
heating

6 Halogen lamp 1 2 ●

7 Cleaning probe ○

8 Mixer ○
9 Dispensing pump ●
Water supply
10 ○
filter net

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Reagent tray
11 ○
cooling system

12 Cooling fan ○

Purified water
13 ○ ●
system

Waste water
14 ○
exhaust

Note:

(a)Number in the sheet is maximum.

(b)Halogen lamp life is 2000 hours. To ensure the accuracy and precision, suggest

replace the lamp after using for 750 hours.

(c)Instrument is suitable for wire printers, inkjet printers, and laser printers, the

user according to the printer select printer supplies.

(d)Execute save the blank weekly. Otherwise will indicate cell blank abnormal

alarm.

(e)If conductivity of purified water is more than 1us/cm,please replace water

purifier consumables.
9.5.2 Users regular replacement accessories sheet
Please prepare below accessories, in case any faults need replacement, please check

sheet 9-3:

Sheet 9-3 Regular Accessories Sheet


Suggest
Stock
No. Accessories Name Remarks
quantity
/Year
1 Halogen Lamp 12V 20W 1
cuvettes(20 24 group
2
units/group×6 group)

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3 Silicone tube 3mm×6mm 10m


Water supply filter net, Used for water tube 2
4
water supply filter holder
5 Dispensing probe Dispensing reagent and sample 1
6 Mixer Used for mixing 1
7 Cleaning probe Clean the cuvettes 1
9.5.3 Maintenance procedure

! Attention:

●Do not drop water, reagent or cleaning fluid to any mechanical or electrical parts,
avoid damage to the instrument.
●When operating, do not touch dispensing probe, mixer and cleaning probe. Avoid
the risk of infection or injury.
●During operation, should take preventive measures, with protective gloves, wear
work clothes. Otherwise, it is possible to contact contaminated areas, contaminated
fluid and infected, or contact with corrosive liquids and damage the skin. If there is
contamination or corrosive liquid accidentally touching the body, please immediately
washing by water and disinfection.
9.5.3.1 Dispensing probe maintenance
If internal and external of the probe is polluted, it is easy to attach serum, reagent and
water drops, also easy to cause the blockage of the syringe tube inside, thus affecting
the instrument test results. Therefore, it is necessary to regularly check and timely
cleaning.
1. Clean up probe outside
(a) Close the total power switch of the instrument.
(b)Scrub the outer wall with cotton swab dipped in alcohol( During the process of
cleaning, do not bend the probe). As shown in figure 9-23

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Figure 9-23 Probe cleaning


(c) After startup again, sample probe automatically return to the position of the reset.
2. Sample probe jam clean up
When the instrument probe blocking, or probes out of flow discontinuity and not
vertical, dripping water, should cleaning the blocked probe.
(a) Close the total power switch of the instrument.
(b) Remove the reagent sample plate cover, revolve the sample probe by hand under
the arm, make it moved to the above reagent sample plate. As shown in figure 9-24.

Figure 9-24 Remove cover


! Warning: Do not hold the probe cap top with hands to revolve the sample probe.

Faulty operation as shown in figure 9-25.

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Figure 9-25 Remove cover


(c)Gently holding probe cap with one hand, move the cover to the side, then loose on
the other side, can take down the needle cap after lift, as shown in figure 9-26.

Figure 9-26 Remove cover


(d) Clipping the fixed cable tie of liquid level signal lines by diagonal pliers, as shown
in figure 9-27.

Figure 9-27 Clipping fixed cable


(e) Remove the liquid level signal lines, need to hold cross arm from below with one
hand, hold 2 p terminal with other hand, remove the liquid level signal lines, note

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cannot pull liquid level signal lines, to prevent the terminal loss, as shown in figure 9-
28.

Figure 9-28 Remove liquid signal line


(f) Stack up absorbent cotton pad on the liquid level board, Prevent water droplets on
the liquid level board when remove hoses, as shown in figure 9-29.

Figure 9-29 Put cotton


(g) Unplug the pipeline of one side of the sample probe. As shown in figure 9-30.

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Figure 9-30 Unplug the pipeline


(h) Counterclockwise unscrewing the needle fixed on the nut, remove the needles.

Figure 9-31 Loosen nut


(I) Put the acupuncture into the needle to clean up from the bottom of the needle. As
shown in figure 9-32

Figure 9-32 Clean needle


(j)After clean up the probe with acupuncture needle, extract 10 ml of pure water by
injection syringe. Put the pure water in the syringe injection probe from the upper,
water flows from needlepoint place, all 10 ml of water discharge, and the water flow
unhindered, as shown in figure 9-33.

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Figure 9-33 Water injection


(k)Install the probe on the cross arm in the reverse order, and installed water pipe, line,
etc.
3. Sample probe position adjustment and confirmation.
(a)Open the instrument of the total power switch, instrument is initialized.
(b) Click the menu bar of the "maintenance", open the instrument detection window,
in the test project list to find sample arm. As shown in figure 9-41.

Figure 9-34 Sample arm

(c)A check of sample probe horizontal position: Click on the sample position “Y”,
sample probe turn left, when the sample probe stop at the upward side of sample
position of reagent sample plate, check whether the pinpoint of sample probe is in the
center of the sample cup, as shown in figure 9-35, then click the zero position "Y",
sample probe is placed back to the initial position.

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Figure 9-35
Attention: If the sample with the tip of the needle is not in the center of the sample
cup, please contact maintenance personnel.
(d) Reagent inner ring level examination: Click the reagent inner ring "Y”, sample
probe turn left, when the sample probe stop at the upward side of reagent inner ring of
reagent sample plate, check whether the pinpoint of sample probe is in the center of
the reagent position of reagent inner ring, then click the zero position "Y", sample
probe is placed back to the initial position.
Attention: If the sample with the tip of the needle is not in the center of the reagent
bottle of reagent inner ring, please contact maintenance personnel.
(e) Reagent outer level examination: Click the reagent outer ring "Y”, sample probe
turn left, when the reagent probe stop at the upward side of reagent outer ring of
reagent sample plate, check whether the pinpoint of sample probe is in the center of
the reagent position of reagent outer ring, then click the zero position "Y", sample
probe is placed back to the initial position.
Attention: If the sample with the tip of the needle is not in the center of the reagent
bottle of reagent outer ring, please contact maintenance personnel.
(f) Reaction cup level examination: Click the reaction cup position "Y", sample probe
turn right, when the sample probe stop at the upward side of reaction cup of the
reaction plate, check whether the sample with the tip of the needle is in the center of
the reaction cup, as shown in figure 9-43, then click the zero position "Y", sample
probe is placed back to the initial position.

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Figure 9-36
Attention: If the sample with the tip of the needle is not in the center of the reaction
cup, please contact maintenance personnel.
(g)Sample vertical position examination: Click the sample position "Y", sample probe
turn left and stop at the top of the sample position, click the vertical position "Y", the
sample probe will continue to drop until the needle tip touches the bottom of the
sample cup, then click the vertical position "Y", the needle is lifted above the sample
position, then click the zero position "Y", sample probe turn right and placed back to
the initial position.
(h) Reagent inner ring vertical position examination: Click the reagent inner ring "Y",
sample probe turn left and stop at the top of the reagent inner ring, click the vertical
position "Y", the sample probe will continue to drop until the needle tip touches the
bottom of the reagent cup, then click the vertical position "Y", the needle is lifted
above the reagent inner ring, then click the zero position "Y", sample probe turn right
and placed back to the initial position.
(i) Reagent outer ring vertical position examination: Click the reagent outer ring "Y",
sample probe turn left and stop at the top of the reagent outer ring, click the vertical
position "Y", the sample probe will continue to drop until the needle tip touches the
bottom of the reagent cup, then click the vertical position "Y", the needle is lifted
above the reagent outer ring, then click the zero position "Y", sample probe turn right
and placed back to the initial position.
(j) Reaction cup vertical position examination: Click the reaction cup position "Y",
sample probe turn right and stop at the top of the reaction cup, click the vertical
position "Y", the sample probe will go down, put the part of the probe which coated
with Teflon into the reaction cup, then click the vertical position "Y", the needle is
lifted above the reaction cup, then click the zero position "Y", sample probe turn left
and placed back to the initial position.

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4. Clean up the washing tank.


Long time without cleaning washing tank will produce the dirt on the inner wall of the
washing tank, and there will be lots of bacteria growing and breeding, under normal
circumstances can be clean once a month. If the instrument is in use process found
dirt, should be cleaned up in time.
(a) If the cleaning tank is contaminated, wipe it with a swab dipped in an alkaline
cleaning solution. As shown in figure 9-37:

Figure 9-37 Clean the cleaning cup


(b) Then, about 100 ml of pure water was poured into each of the washing tank to be
washed.
9.5.3.2 Reaction plate maintenance
If the reaction cup or thermostat is contaminated, may result in inaccurate test results.
In addition, the reaction cup will occur for a long time aging, so the reaction cup
should be cleaned regularly, and check the reaction cup absorbance, when the
absorbance value is abnormal, the reaction cup should be replaced in time.
! Warning: Non-professional maintenance personnel, prohibit the demolition

reaction plate gland film, reaction plate gland and reaction cup positioning plate,
otherwise it will affect the light path, the reaction cup positioning.
1. Cleaning reaction cup
It is recommended that the user perform a cleaning reaction cup function every day to
avoid contamination of the reaction cup and affect the test results, the operation
should be carried out at the end of each day after the 120 cuvettes cleaning, the
specific operation is as follows,
(a) Add the cleaning solution to the reagent position: The alkaline cleaning solution
into the 50mL reagent bottle, placed in the reagent bit 28 as figure 9-38;

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Figure 9-38 Cleaning solution


(b) Add the cleaning solution to the reaction cup: In the "Maintenance" form, click the
"clean background", then click the "cleaning solution" on the right side to select the
need to wash the cuvettes range( E.g. 1-120). Click "OK", the instrument begin to add
cleaning solution, the software interface is as follows figure 9-39.

Figure 9-39 Software interface


(c) Soak for 5 minutes.
(d) Wash the reaction cup, in the "Maintenance" form, click "Cleaning", select the
right side of the need to wash the cupping range, ( E.g 1-120). Click "OK", the
instrument begins to clean, the software operation interface is as follows figure 9-40:

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Figure 9-40 Cleaning interface


2. Confirmation of reaction cup stains

During the sample test, click on the menu bar , can realize real-time monitoring
of the reaction state of the instrument, if the dirty cup is detected during the test, the
instrument will automatically skip the dirty cup and use the next cup. In the
monitoring, the cup will show red, as shown in figure 9-41,

Figure 9-41 Sample tray monitor

3. Replace the cuvette

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When there are too many dirty cup , test speed will be affected. If in the software

shows the dirty cup more than 1/3 of reaction tray, please replace new cuvette.
Operations are as follows:
(a)Turn off the instrument main power switch, remove the reaction plate tray;
(b)Wear protective gloves and unscrew the cuvette pins, as shown in Figure 4-42.

Figure 4-42 Replace cuvettes


(c)Remove the six groups cuvettes, as shown in Figure 9-43:

Figure 9-43 Replace cuvttes


(e) Install the six new cuvettes in the reverse order onto the reaction tray.
(f)Turn on the instrument's power switch.
(g) Perform the "Washing&&Background" in the "Maintenance" form and use the
cleaning fluid to clean the cuvette before testing.

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Attention1: If the used cuvette is exposed to air for long periods of time,
contaminants may build up on the cup wall. So should be promptly covered with
reaction tray cover. In addition, if the emergency stop during the test, should
clean cuvettes which not be cleaned or rinse them with pure water to avoid the
reaction fluid remain in the cuvette for a long time.

Attention2: Forbid to use organic solvents (benzene, alcohol, etc.) scrub or


soak the cuvette.
4. Clean the reaction tank
After long-term use of the reaction tan, it should be promptly cleaned to prevent dust
and other effects of test results. In addition, please wipe timely, especially when water
flows into, to prevent contamination of the cuvette and lighting path, affecting the test
results.
Reaction tank cleaning method:
(a) Turn off the instrument main power switch, remove the reaction tray cover;
(b) Wear protective gloves and remove the cuvette pins, as shown in Figure 4-49;
(c) Remove the six groups of cuvettes, placed in pure water or clean place, as shown
in Figure 4-50;
(D) Wipe the reaction tank with a clean and wet gauze (not to wipe the photometric
window), as shown in Figure 9-44:

Figure 9-44 Wipe reaction tray


(e)After cleaning the reaction tank, install the reaction cup and cover the reaction tray
cover.

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9.5.3.3 Maintenance of the light source lamp


Halogen inspection: If light source lamp aging, light energy will deviate from test
range of light. During the sample test, it won’t test correctly because of interfere. In
the "instrument detection" interface for non-blocking AD readings test, if less than
20,000, should replace the halogen lamp. To replace the halogen lamp, proceed as
follows:
(a) Prepare a new halogen lamp, as shown in Figure 9-45:

Figure 9-45 Halogen lamp

Attention: Do not touch the surface of the halogen lamp, otherwise the
amount of light will be affected. If you find fingerprints and other stains on the
surface, you can wipe with alcohol gauze.
(b) Turn off the instrument's main power switch, and after about 30 minutes (wait the
lamp compartment to cool completely), perform the next operation to avoid burns;
(c) Remove the three plugging plugs on the rear plate and unscrew the three screws
with a Phillips screwdriver. Operation as shown in Figure9-46;

Figure 9-46 Back cover

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(d) Remove the rear plate, as shown figure 9-47;

Figure 9-47 Remove the rear plate


(e) Remove the protective cover from the terminal block. Use a Phillips screwdriver
to unscrew the two fixing posts of the halogen lamp lead. Remove the white silicone
leads and cut the two tie strips with a slanting mouth to facilitate replacement of the
halogen lamp. As shown in Figure 9-48;

Figure 9-48 Replace halogen lamp


(f) Unscrew the two fixing screws on the light source holder (located above the rear
fan), remove the halogen lamp holder screw, and remove the halogen lamp as shown
figure 9-49;

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Figure 9-49 Loosen screws


(g)According to the above converse steps to replace the new halogen lamps, pay
attention to tighten the screws. Lead wire should not be loose or cocked.
(h) Turn on the instrument and the instrument is initialized. After the instrument is in
standby mode, check whether the spot size satisfied 5mm. Then, test the do not block
the AD readings on the "Instrument Check" interface and it should start when the
value higher than 20000.

Attention: The protective cover on the terminal block must be installed to


prevent short circuit on the terminal block.
9.5.3.4 Cleaning mechanism maintenance
If the nozzle of the cleaning mechanism is clogged, the reaction cup can not be
cleaned, which will affect the accuracy and precision of the test result, and may cause
other faults of the instrument. In addition, if the cleaning water spills into the reaction
tank, it may cause the test data is not accurate.
1. Clean the cleaning probe outer wall
(A) Turn off the instrument's main power switch.
(B) Wipe the outer wall of the nozzle with a cotton swab dampened with an alkaline
cleaning solution, and wipe off the cleaning solution on the surface of the pin with a
cotton swab dampened with pure water (do not bend the needle during wiping). As
shown in Figure 9-50.

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Figure 9-50 Clean cleaning probe


2. Clean the cleaning probe block
(a) Turn off the instrument's main power switch.
(b) Unscrew the corresponding needle cleaning hose, as shown in Figure 9-51:

Figure 9-51 Cleaning hose


(c) with 0.5mm stainless steel wire from the bottom of the nozzle through the plug to
clean up the block, as shown in Figure 9-52:

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Figure 9-52 Clean the block

Attention: Do not bend the nozzle during operation.


(d) Insert the silicone tube.
(e) Turn on the instrument's power switch.
(f) In the "Maintenance" menu bar, click the "instrument check" form, find the
"washing&&background", check whether the clean probe water injection is normal,
pumping is clean.
9.5.3.5 Mixer probe maintenance
If the mixer probe is contaminated, it will cause cross-contamination, thus affecting
the accuracy and precision of the test results. So should wipe the outer wall of the
probe regularly dipped in alkaline cleaning solution with a cotton swab. In addition,
replace the pin if the it is bent.
1. Mixer probe cleaning
Mixer probe cleaning: wipe with a cotton swab dipped in alkaline cleaning solution,
and then wipe with a cotton swab dipped in water to clean the clean fluid on the
surface of the it(in the wiping process, do not bend the mixing probe), as shown in
Figure 9-53:

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Figure 9-53 Clean mixer


2. Mixer probe replace
(a) Turn off the instrument's main power switch.
(b) Remove the reaction tray cover.
(c) Loosen the two setscrews with a Phillips screwdriver for a week, as shown in
Figure 9-54: Pull the pin downwards.

Figure 9-54 Loosen screw


(d) Wipe the tip of the new mixing needle with a cotton swab dampened with an
alkaline cleaning solution, and wipe off the cleaning solution on the surface of the
needle with a cotton cloth dampened with pure water (do not bend the needle during
wiping).
(e) When installing the new mixing pin, insert the pin into the shaft of the motor shaft
and secure with the M2 screw, as shown in Figure 9-55:

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Figure 9-55
NOTE: The pin must be securely fastened to prevent instrument malfunction.
(F) Raise the mixer arm to the top, and rotate the agitator arm in the direction of the
cuvettes by hand (same as reagent arm operation), as shown in Figure 9-56, so that the
height of the stirrer is about 1.3cm.

Figure 9-56 Raise mixer arm


(g) Turn on the instrument power switch and initialize the instrument.
(h) Open the "instrument check" form in the menu "Maintenance", find the mixing
arm, as shown below, click the cuvettes position "Y", check the level position of the
cuvette, confirm whether in the center of the cuvette. If yes, click zero position "Y"
and the mixer probe will return to the top of the clean cup.

Figure 9-57

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See the location of the pin in relation to the cuvette in a top-down view, as shown in
Figure 9-58:

Figure 9-58
Note: If not in the center of the reaction cup, please contact the service staff.
(i)Mixer probe’s vertical position check: In the "Instrument Check" window, click the
cuvette position "Y", the probe will move to the top of the cuvette, then click the
vertical position "Y", the mixer probe down. Click the vertical position "Y" again, the
mixer probe lift. Finally click the zero position "Y", the mixing probe will return to
the top of the cleaning cup.
9.5.3.6 Reagent sample tray maintenance
The instrument reagent sample tray has reagents refrigerated storage reagent function.
Reagent sample tray is divided into sample position, reagent inner ring and reagent
outer ring. 49 sample position, 56 reagent position, as shown in Figure 9-59.

Figure 9-59 Reagent position

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Attention: Reagent can not be too full to ensure that below the top of the
reagent location as above figure, otherwise it will affect the level detection.
1. Replace the reagent bottle
When reagent less than the remaining time, please replace the reagent bottle. 50mL
reagent bottle can only be placed in the reagent inner circle, 20mL reagent bottle can
be set not only in the reagent outer ring, but also in the reagent inner ring. Place the
reagent bottle as follows:
(a) 50mL reagent bottle placed: bottle near the reagent outer ring;
(b) 20mL reagent bottle placed in the reagent outer ring: the mouth of the bottle near
the reagent inner ring;
(c) 20mL reagent bottle placed in the reagent inner ring: the bottle near the reagent
outer ring, and needed for fixed block (box attached) as shown in Figure 9-60. After
placing the reagent bottle, fix the reagent bottle with the fixing piece and then insert
the fixing block vertically into the bottom.

Figure 9-60 Fixed block

Attention: Must put the reagent bottle first, and then put a fixed block, to
prevent friction damage to the reagent bottle bar code.
2. Reagent sample tray clean
The sample tray will be contaminated with reagents, samples and dust for a long time
use, and condensation water will be generated during the cooling process, so it should
be cleaned once a day.
(a) Remove the reagent sample tray cover;
(b) Unscrew the reagent tray handle counterclockwise to remove the reagent sample
tray.

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Figure 9-61 Remove reagent tray


(c) Wipe the inside of the reagent sample pan with a wet gauze and wipe the
condensate from the reagent sample pan to the condensate drain.

Figure 9-62 Wipe out the water


3. Refrigeration liquid added
When the cooling level float switch is lowered to the lowest level, the liquid level
alarm panel will sound an alarm and the right side panel alarm indicator flashes to
indicate the lack of cooling liquid, as shown in Figure 9- 63.

Figure 9- 63 Alarm
The procedure for adding the refrigerant is as follows:
(a) Turn off the main power switch of the instrument;
(b) Remove the three plugging plugs on the right side plate and unscrew the three
screws with a Phillips screwdriver, as shown in Figure 9-64;

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Automatic biochemistry analyzer BK-200 user manual

Figure 9-64 Remove side cover


(c) Open the right side panel of the instrument;
(d) Find the coolant fill line as shown in Figure 9-65

Figure 9-65 Coolant fill line


(e) Find the funnel in the accessory box and prepare the refrigerant;
(f) Open the pipe hose clamp and plug which add refrigerant, install the funnel to add
refrigerant, as shown in Figure 9-66;

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Figure 9-66 Add coolant


(g)Add to the cooling tank 2/3 to complete the add, as shown in Figure 9-67, and
install the pipe plug and hose clamps, install the instrument on the right side of the
board to complete the operation.

Figure 9-67 Coolant level


Warning: open the right board do not break communication line of alarm board.
9.5.4 Daily operation
Boot operation
1, before the test to check the pure bucket, bucket;
2, check the sample needle, needle position whether or not blocked;
3, check the cleaning cup and waste water pipe whether or not blocked.
Close machine operation:
1, clean the reaction cup, empty the sample tray to test the sample, the reagent
covered with the corresponding cap , then cold storage.

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2, treatment of waste water bucket.


3, add pure water to the reaction cup,then save the background.
4, turn off the machine power supply, cover the machine cover.
9.6 instrument failure and treatment
The fault of the instrument can be divided into failure and alarm failure according to
different problems.
9.6.1 The way to deal with the failure of alarm
Analysis and solution of instrument failure alarm as sheet 9-4.
Sheet 9-4 Instrument failure alarm analysis table
Fault information Main reason solution
Sample probe tip with 1.Sample tip is dirty 1.Wipe the probe with cotton
water droplets 2.There is a leak in the swab alkaline cleaning
pipeline or filler of the solution
sampling filling 2.Maintenance and inspection
mechanism
There is a drop of water 1.The cleaning mechanism 1.Check interface
droplets on the washing of pipeline leakage 2.clean the maintenance of the
needle. 2.Nozzle, pipe blockage body, if you want to replace
the hose please contact the
sales staff
Clean nozzle without 1.Nozzle, pipe blockage clean the maintenance of the
the water body, if you want to replace
the hose please contact the
sales staff
Reaction cup water Nozzle, pipe blockage clean the maintenance of the
overflow body, if you want to replace
the hose please contact the
sales staff
Injection pump leakage 1.Poor interface parts 1.Confirm leaks and reinstall
2.Pump leakage 2.Replace injection pump

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Automatic biochemistry analyzer BK-200 user manual

Fault information Main reason solution


There are bubbles in the 1.interface parts install not 1.Confirm the air inlet and
injection pump. good. reinstall
2.Filling device exhaust is 2.Implementation of the
not enough system in the maintenance
of the exhaust, if there is a
small bubble can not be
removed, you can move in
the reagent or cleaning
water, gently tap the
injection pump, use of
vibration to eliminate
Abnormal level of liquid 1.problem of Liquid level 1. Confirm whether the
level sensitivity setting level plate sensitivity is set
2.Instrument grounding correctly
problems 2. Check whether the
3.There is a large ground is connected
electromagnetic 3. Check whether there is a
interference large electromagnetic
interference around
Absorbance beyond The absorbance of the 1. Make sure the reagent
reaction liquid is beyond is prepared and the
3.0Abs position is correct
2. Check whether has
impurity in sample
3. Check whether there is
any impurity in the
reaction tank warm
water
4. Check the reaction cup
whether or not cracks
and scratches

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5. Check whether the


optical window is
clean or has water
Reaction disk anomaly 1. Reaction disk Unable 1. Confirm the
to locate stop position optocoupler under the
2. The reaction tray is not covered on the disc
in the specified plate without abnormal
position reaction
2. Check the optocoupler
and the electrical
wiring whether or not
off and abnormal
contact

Fault Main reason solution


information
Sample injection 1. Left and right 1. Check whether the optocoupler block
probe moves motion is abnormal
abnormal abnormalities 2. Check whether the corresponding
2. Up and down optical coupler and the electrical
motion wiring of the Electric machinery is
abnormalities abnormal
3. Check whether the corresponding
drive plate installation is abnormal
Reagent sample 1. Reagent sample 1. Confirm the the optocoupler plate
disk anomaly disk moves under the Reagent sample disk is
anomaly normal
2. Reagent sample 2. Check whether the optocoupler and
tray is not the electrical wiring is off or
initialized at zero abnormal contact
position 3. Reagent sample disk Pallet is
loosing
4. The reagent sample tray adjustment

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Automatic biochemistry analyzer BK-200 user manual

position is unreasonable, and the


zero position should be on the
reagent needle horizontal within the
range of 90 degrees

Fault information Main reason solution


Reproducibility 1.Do not maintain the 1.Maintain the equipment
not good equipment regularly regularly according to user's
2.Chemical reagents go bad, Manual
There are chemical 2.Replace the new reagent, and
substances Precipitation or correct storage and use of reagents
has impurity substance 3.The conductivity of pure water
3.Purifier water quality is should be below 1 s/cm
not good 4.Add the cleaning solution to
4.Cleaning is not thorough clean the reaction cup thoroughly
5.Reagent crystallization 5.Replace reagent
6.Analysis of projects have 6.Spacing placement the reagent
Cross contamination which has Cross contamination, or
7.Sample unqualified(Fibrin use the Cross contamination
in the sample) program to avoid it
8.There is a large 7.The samples unqualified were
electromagnetic interference centrifuged again
8.Remove interference source
Poor accuracy 1.Calibration solution 1.Add The calibration liquid to the
concentration or Invalid sample cup immediately use and
2.analysis condition setting preserve correctly
is not good 2.Set parameters correctly
No response after 1.Poor contact of power 1.check the power input part
the instrument plug wiring
boot 2.Instrument insurance tube 2.Replace the safety tube and
burn check the line
9.6.2 The content and solution of alarm information
The analysis and solution of the instrument failure of alarm as sheet 9-5:

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Automatic biochemistry analyzer BK-200 user manual

Sheet 9-5 The analysis and solution of the instrument failure of alarm table
Alarm Alarm describe Treatment recommendations
number source
512 Sample The sample plate is Press the shortcut key [Ctrl]+[F3] to
plate not moved to the reset the device and try again. If the
specified position problem persists, contact your service
person
1290 Sample Not down Press the shortcut key [Ctrl]+[F3] to
arm reset the device
1802 R2 arm Not down Press the shortcut key [Ctrl]+[F3] to
reset the device
1803 Sample Sample needle’s make complete the sample quantity
needle pipetting not enough, and re test
position[{0}].
1804 R1 arm Not detect the Recommend the implementation of a
reagent, reagent residue detection to ensure that
position[{0}]. there are enough reagents in the
reagent bottle
1805 R2 arm Not detect the Recommend the implementation of a
reagent, reagent residue detection to ensure that
position[{0}]. there are enough reagents in the
reagent bottle
1806 Sample Sample needle block Recommend the implementation of a
needle reagent residue detection to ensure that
there are enough reagents in the
reagent bottle
2059 AD Unable to receive Please contact service person
module absorbance data of
module
2060 AD Data acquisition Please contact service person
module module interrupt
abnormal
P45

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Automatic biochemistry analyzer BK-200 user manual

Alarm number Alarm source describe Treatment


recommendations
2304 Purified Water Net bucket supply Adequate
Bucket deficiency purifier water
outside the
instrument
2305 Purified Water Lack of water supply Adequate
Bucket outside the purifier water
instrument leads to outside the
insufficient water instrument
in Purified Water
Bucket
2306 Purified Water Purifier water Suspended water
Bucket bucket is too full purifier
3335 system Send data to LIS Please check
serial port timeout whether normal
link to LIS
3584 Reaction disk The water blank is Cleaning reaction
not standard, the cup
reaction cup may is
dirty
4097 Bulb abnormal Bulb energy Check the bulb, re
abnormal test, if still alarm,
please contact the
maintenance person
4098 Data acquisition Did not receive the Proposed check
communication maximum number line
abnormal of cups
4099 Data acquisition OD module does Proposed check
communication not adjust the gain line
abnormal
4353 The device break Start test signal Check the sample
down timeout and reagent margin,

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Automatic biochemistry analyzer BK-200 user manual

reset and run again


4354 The device break Reaction disk stop Proposed reset and
down signal 1 timeout run again
4355 The device break R1 arm action check the sample
down timeout and reagent margin,
reset and run again
4356 The device break Cleaning arm Proposed reset and
down action timeout run again
4357 The device break Stirring arm Proposed reset and
down movement 1 run again
timeout

Alarm Alarm source describe Treatment recommendations


number
4358 machine Timer 1 times out advice after resetting , run
malfunction again
4359 machine Reaction disk stop signal advice after resetting ,run again
malfunction 2 timed out
4360 machine Sample arm action Check the sample and reagent
malfunction timeout. margin, reset and run again
4361 machine Get Reagent R2 action Check the sample and reagent
malfunction timeout margin, reset and run again
4362 machine Stirring arm movement 2 advice after resetting , run
malfunction timeout again
200015 Reagent Reagent Please re - scan after the new
plate position={0},bar item parameters added

code={1}:Unknown

new reagent
200016 Reagent Reagent Please confirm the reagent bar
plate position={0},bar code and then scan it again

code={1}:Reagent bar

code is invalid

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300000 data Error while querying Check the corresponding


processing reference value reagent parameter settings to
ensure that the project reference
values are set up.
300001 data An error occurred while Check the corresponding
processing calculating the test reagent parameter settings
application result
300002 data An error occurred while Please check the database
processing generating the test service is correct, or contact
application technical support personnel
300003 data An error occurred while Check the corresponding
processing calculating the sample reagent parameter settings
result of the sample
300004 data Error while updating Please check the database
processing sample status service is correct, or contact
technical support personnel

Alarm Alarm source describe Treatment


number recommendations
300007 data processing The test results exceeded Please check the status of

the valid range,time={0} the sample on the sample


tray
,sample number={1},

Item code={2},Repeat

number={3}。

300008 data processing An error occurred during Please check the previous
the automatic calibration project fitting parameters
of reagent {0}: {1}. and status, and to ensure
that the standard quantity is
sufficient for fitting the
current
300009 data processing Reagent bottle empty, Please check the location

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Automatic biochemistry analyzer BK-200 user manual

position: {0} of the reagent bottles


300018 data processing Electrolyte calibration was Please apply for electrolyte
not passed calibration again
300020 data processing The requested barcode {0} Make sure the LIS return
does not contain any test information is correct
items
300023 data processing Failed to send data to LIS Please check whether the
via database. Sample LIS link is normal.
number = {0}
400022 Communication The host computer and the Contact after sales staff
board slave computer version
does not match, the PC
version {0}, the next
version of the {1}
400070 data processing {0} position sample value Add samples
is insufficient
400071 data processing {0} position no sample Add samples
400072 data processing Lack of reagent Add reagent
400073 data processing No reagent Add reagent

Alarm Alarm source describe Treatment recommendations


number
400074 Sample drive Sample driver Please check Sample driver
module module module
communication
abnormal
400075 Reagent R1 Reagent R1 driver Please check Reagent R1 driver
drive module module module
communication
abnormal
400076 Reaction disk Reaction disk module Please check Reaction disk
module communication module
abnormal

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400077 AD module AD module Please check AD module


communication
abnormal
400078 electric circuit Exhaust not Please check electric circuit
completed
8401 Cleaning liquid Lack of lye After the test, please add in
time to avoid affecting the
normal test
8405 Cleaning liquid Alkaline cleaning Please add alkaline cleaning
liquid has been used solution to continue to test
up
60001 Adapter Network connection Please turn off the host
error, network card is computer software, and then
disabled or not start the device until the
connected network connection is normal,
and then re run the host
software
60002 Communication Communication Please turn off the host
board abnormal! software, and then restart the
device, and then re run the host
software
60003 Communication Data return length Please check the
board error communication line or
communication board
60004 Adapter offline Please check the
communication line, and then
run the host software
60005 Adapter Port number off Please turn off the host
software, and then restart the
device, and then re run the host
software

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Alarm Alarm describe Treatment recommendations


number source
60006 Adapter network not connect Please turn off the host software,
and then start the device until the
network connection is normal, and
then re run the host software.
60010 Adapter Software and Please contact the engineer to re
instrument number configure the software
does not match
60011 Strike Strike needle ,The Please contact the service person
needle instrument movement
is abnormal and stop
adding sample.
100000 Reagent Reagent information Please check if the parameters of
plate not found. Reagent reagent is existence and determine
code ={0}. that the reagent is also set on that
reagent plate
100001 Test An error occurred Please check the communication
application while downloading the line is normal, and determine
test application whether the instrument is in
standby or normal working state
100002 Test An error occurred Please check the communication
application when the instrument line is normal, and determine the
began testing the instrument is in standby mode
sample
100010 data An error occurred Please Check database parameters
processing while loading and and status, contact technical
refreshing the sample support person
tray state

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Alarm Alarm describe Treatment recommendations


number source
100011 data Automatic re-check failure Please Check database
processing parameters and status,
contact technical support
person
100012 data Invalid fitting type code. Please check the previous
processing Item = {0}. project fitting parameters and
state
100013 Reaction The reaction disk
disk temperature is too low to
ensure that the test results
are correct, Test has stopped
100014 Reaction The reaction disk
disk temperature is too high to
ensure that the test results
are correct, Test has stopped
100015 Reaction reaction disk’s temperature
disk is low, test results may be
affected
100016 Reaction reaction disk’s temperature
disk is high, test results may be
affected
100017 Reaction The reaction plate
disk temperature sensor not
linked or damaged.
100022 data Invalid instrument type Try reinstalling the program
processing or contact your service
provider
100023 Sample Sample arm initialization Please restart, or contact
arm error. technical support person
100024 Reaction The initial error of the Please restart, or contact
disk moving part of the reaction technical support person

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disk
100025 Stirring Stirring arm initialization Please restart, or contact
arm error technical support person
100026 others Unable to get the basic Please check the database
information from the service is correct, or contact
database <= Alarm ID={0} technical support person

Alarm Alarm source describe Treatment


number recommendations
100031 Date Check failed after Try reinstalling the
processing initialization program or contact your
service provider
100032 others Instrument initialization Proposed to restart the
failed slave computer
200000 Reaction The cup blank value is Please clean the reaction
plate lower than the lower limit, cup and replace the reaction
the reaction cup number is cup if necessary
={0}
200001 Reaction The cup blank value is Please clean the reaction
plate lower than the lower limit, cup and replace the reaction
the reaction cup number is cup if necessary
={0}
400079 Reagent R2 Reagent R2 driver module Please check the reagent R2
drive module communication abnormal driver module
400080 Stirring drive communication module Please check the stirring
module Abnormal module

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Appendix A Electrical Schematic Diagram

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Appendix B Liquid road connection diagram

Note: In the figure, the dotted line box is reserved for defoaming function.

169
Appendix C Products supporting reagents
Specific table below (BIOBASE commonly used biochemical reagents parameter table)

Min Max Pri- Pri- Sub- Sub- Normal Normal


Sample R1 R2 Primary Sample Decimal
Item Full Name Analysis Method Unit Absor Absor Start End Start End High Low
Volume Volume Volume Wavelength Types Place
bance bance Point Point Point Point Value Value

ALB Albumin 5 300 0 578 One Point End serum 1 g/L 0 3 30 30 0 0 55 35

ALP Alkaline Phosphatase 6 240 60 405 Rate method serum 0 U/L 0 3 22 30 0 0 135 45

ALT Alanine Amino Transferase 22 240 60 340 Rate method serum 1 U/L 0 3 23 33 0 0 41 0

AMY α-Amylase 7 250 90 405 Rate method serum 0 U/L 0 3 23 33 0 0 104 25

ApoA1 Apolipoprotein A1 5 225 75 340 Two Point End serum 2 g/L 0 3 35 35 12 13 1.9 1.2

ApoB Apolipoprotein B 5 225 75 340 Two Point End serum 2 g/L 0 3 35 35 12 13 1.5 0.6

ASO Antistreptococcus O 5 240 60 578 Two Point End serum 0 IU/mL 0 3 28 29 19 20 166 0

AST Aspartate Amino Transferase 22 240 60 340 Rate method serum 1 U/L -1 3 22 33 0 0 40 0

BMG β2-Micro Globulin 5 225 75 578 Fixed time method serum 1 mg/L 0 3 21 28 0 0 1.8 0.8

CHE Cholinesterase 5 250 50 405 Rate method serum 0 U/L 0 3 22 30 0 0 12600 3930

CHO Cholesterol 4 300 0 510 One Point End serum 2 mmol/L 0 3 15 15 0 0 5.2 2.34

CK Creatine Kinase 15 240 60 340 Rate method serum 0 U/L 0 3 22 30 0 0 190 0

170
CK-MB Creatine Kinase Isozyme 15 240 60 340 Rate method serum 1 U/L 0 3 22 30 0 0 25 0

Creatinine(Alkalinity Picric Acid


CREA 15 240 60 510 Fixed time method serum 1 umol/L 0 3 22 30 0 0 115 53
Method)

CRP C-reaction protein(normal) 20 225 75 340 Two Point End serum 2 mg/dL 0 3 35 35 12 13 0.8 0

Direct Bilirubin(Vanadate oxidation


DBIL 9 240 60 450 Two Point End serum 2 umol/L 0 3 35 35 12 13 6.8 0
method)

GLU Glucose(Oxidase Method) 6 300 0 510 One Point End serum 2 mmol/L 0 3 34 35 0 0 6.4 3.89

Saccharify Gemoglobin(Latex original


HbA1c 10 225 75 630 Two Point End 2 % 0 3 33 33 20 21 5.8 3.8
enhanced immune turbidimetry) blood

HCY Homocysteine 24 240 60 340 Rate method serum 1 umol/L 0 3 21 29 0 0 15 0

HDL-C HDL-Cholesterol 5 225 75 546 Two Point End serum 2 mmol/L 0 3 35 35 12 13 2.25 0.77

LDH Lactic Dehydrogenase 6 240 60 340 Rate method serum 0 U/L 0 3 22 30 0 0 225 135

LDL-C LDL-Cholesterol 5 225 75 546 Two Point End serum 2 mmol/L 0 3 35 35 12 13 3.35 0

TBA Total Bile Acid 5 225 75 405 Fixed time method serum 1 umol/L 0 3 22 28 0 0 20 0

Total Bilirubin(Vanadate oxidation


TBIL 24 9 225 75 Two Point End serum 0 umol/L 0 3 35 35 12 13 20.5 2
method)

TG Triglyceride 5 300 0 510 One Point End serum 2 mmol/L 0 3 35 35 0 0 1.7 0.7

UA Uric Acid 5 240 60 546 Two Point End serum 0 umol/L 0 3 35 35 12 13 480 140

UREA Urea 5 225 75 340 Fixed time method serum 1 mmol/L 0 3 22 30 0 0 8.3 1.7

TP Total Protein 6 300 0 546 One Point End serum 1 g/L 0 3 34 35 0 0 88 60

171
α-HBDH α-Hydroxybutyric Acid Dehydrogenase 5 240 60 340 Rate method serum 0 U/L 0 3 22 30 0 0 182 72

GGT/γ-
γ-GlutamoylTransferase 6 225 75 405 Rate method serum 0 U/L 0 3 22 30 0 0 47 0
GT

172
Appendix D Cross contamination reference table

Project Method principle Method Method


name principle principle
TG oxidase methods → TBA Enzymatic
cycling assay
TC oxidase methods → TBA Enzymatic
cycling assay
CHE Substrate → TG Oxidase
hydrolysis method
LDL-C Direct method of → GLU(OX) Oxidase
determination method
HDL-C Direct method of → GLU(OX) Oxidase
determination method
CK IFCC → Mg Methylene
Blue
FMN NBT return method → CHE Substrate
hydrolysis

The above cross-contamination only is taken for example when BIOBASE reagents
is tested on the BIOBASE series of automatic biochemical analyzer.
The reagent formula’s changing in cross-contamination, so the above test is only for
reference, if not, please refer to the actual test situation.

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