BK 200mini User Manual 2019.5.4

Auto Chemistry Analyzer
User Manual
BK-200mini
Jinan Biobase Biotech Co., Ltd

Preface
Thank you for purchasing BK-200mini Auto Chemistry Analyzer.

Product name: Auto Chemistry Analyzer
Model: BK-200mini
Medical device registration certificate number / product technical
requirements number: Drug Administration word 2014 No. 2400384
Production license number: Drug Administration word 2014 No. 2400384
Product performance structure and composition: It consists of analysis
department, operation department (computer system), result output department
(printer), accessories and consumables.
Intended use: It is used to quantitatively analyze the clinical chemistry of human
serum, plasma, urine, cerebrospinal fluid and other samples. Do not use for other
purposes.
Company name: Shandong Biobase Biotech Co., Ltd
Address: NO.51 South Gongye Road, Jinan, China
Production date: Check product label
Period of use:
The expected life of the instrument is 5 years, but it can be used for a long time
under normal maintenance conditions. The expected service life of this product is
determined by the durability test method. The operator should maintain, maintain
and repair the product according to the requirements of the user manual. After
maintenance, maintenance and repair, the product can be confirmed to maintain
basic safety and Effective product, can be used normally.
Revision statement
This document applies to the latest and higher version of the software listed. If
the subsequent software version changes the information in this file, a new
version will be released.
Initial version: V1.0, 2019.2
Software version: M2.1.1.1
The purpose of creating this document is to improve the content and usability of
the user manual.
Intellectual property
The intellectual property of this user manual and its corresponding products
belongs to Shandong Biobase Biotech Co., Ltd. (hereinafter referred to as
―Company‖)
No individual or organization may reproduce (including photographing,
reprinting, transcription, etc.), copy, modify or translate any part of this manual
without the prior written consent of the company.
If the contents of this user manual are changed, the user will not be notified.
Statement
Shandong Biobase Biotech Co., Ltd (hereinafter referred to as ―Company‖) has
the final interpretation right of this user manual.
The company is responsible for the safety, reliability and performance of the
product when all of the following requirements are met:
 Assembly operations, expansion, re-adjustment, improvement, repair and
replacement of parts are performed by professionals recognized by the
company.
 All repairs involving replacement parts and supporting accessories and
consumables are original (original) or approved by the company.
 The relevant electrical equipment complies with national standards and the
requirements of this user manual.
 Product operation is carried out in accordance with this user manual.
User
The readers of this user manual are the following laboratory specialists.
 Personnel who perform daily operations of the system.
 Personnel performing system maintenance and troubleshooting.
 Person who learns system operation.
Please read the contents of this user manual carefully before using the product
and use the product correctly. Please keep this user manual in a safe place so that
you can check it out at any time. If the precautions stated in this user manual are
not followed during use, no warranty will be given.
Dimensions and weight

External size: 625mm×425mm×460mm
Net weight: 36kg
Product Categories
The classification criteria are described below
 Overvoltage category: Overvoltage category (Ⅱ)
 Pollution level: Pollution level(Ⅱ)
 Noise level: 75dB(A distance of more than 1m from the analyzer)
 Installation environmental conditions:
a) Indoor use.
b) Altitude does not exceed 2000m.
c) Temperature range 15 ℃ ～ 30 ℃.
d) The maximum relative humidity is 85% when the temperature is lower
than 30 ℃.
e) Power supply voltage fluctuation is not more than ±10% of the
nominal voltage.
f) Typical transient overvoltage present on the mains supply.
Note: The nominal level of transient overvoltage is the pulse withstand
voltage (overvoltage) category II specified in GB 16895.12.
g) Applicable rated pollution level.
h) No abnormal noise equipment nearby.
i) The equipment complies with the emission and immunity requirements
of GB/T 18268. It is forbidden to use the equipment beside strong radiation
sources (such as unshielded RF sources), otherwise it may interfere with the
normal operation of the equipment.
 Equipment category: laboratory equipment
 Connection to the network power supply: detachable power cord
 Operating conditions: continuous
Transportation and storage

 Transportation
When the instrument is in the packaging status, take care to prevent rain and sun
exposure during transportation to prevent severe impact, heavy pressure and
dumping.
If the instrument has been unpacked and needs to be moved, repack the
instrument before shipping.
 Storage
The packaged instrument should be stored at -10 ℃ ～ 40 ℃, relative humidity
is not more than 85%, no corrosive gas and well ventilated environment.
Warranty and repair services

The warranty period of the purchased product is subject to the sales contract.
Supplies are not warranted for consumable
The following conditions will not be covered by the warranty.
 The customer has not filled in and returned the equipment warranty card
within 30 days after the installation acceptance is completed.
 The serial number of the equipment provided by the customer is
incorrect.
 Malfunctions and damages caused by violation of the usage, precautions
and intended use described in this user manual.
 Failure and damage caused by operations such as inspection
professionals, doctors or laboratory personnel trained by the company or
the agent designated by the company.
 Failure and damage caused by repair or modification of the other
company.
 Failure and damage caused by use with instruments other than those
specified by the company.
 Failure and damage caused by the inconsistency between the operating
environment and the operating environment (power supply conditions,
installation environment, etc.) specified by the company.
 Failure and damage caused by irresistible natural disasters.
 Failure and damage caused by the company's unintentional movement or
transfer (transport) after the equipment is installed.
 If the instrument fails due to the use of consumables such as reagents not
approved by the company, it is not within the scope of the company
providing maintenance services.
 Other failures caused by non-products themselves.
 During the warranty period, if there is a failure caused by defects in the
design and manufacture of our company, the repair will be carried out
without compensation. Our company will take corresponding
countermeasures according to the fault content.
 After the warranty period expires, the company can continue to provide
fee-based repair services.
After-sales service and contact information

 After sales service
Please contact the company's customer service center

 Service
a) Confirm the fault and repair method: first contact the customer service
center to confirm the fault condition, and confirm that the repair method is
home repair or return to the factory for repair.
b) Maintenance costs are negotiated with the company according to the
specific situation.
c) Freight: If the instrument is shipped to the company for maintenance, the
user must bear the freight (including customs fees).
 Return
a) Obtain a return permission. Get in touch with the company's customer
service center and inform the product serial number (see the instrument
nameplate) to explain the reason for the return. If the product serial number
cannot be clearly identified, the company will not return the product.
b) Under the premise of obtaining the right to return the goods, please
follow the company's requirements to handle the relevant procedures.
 Contact information
Company name: Jinan Biobase Biotech Co., Ltd

Address: NO.51 South Gongye Road, Jinan, China
Service Email: export@biobase.com
Phone: +86-531-81219801/03
Zip code: 250000
Preface
This user manual describes in detail the use, function and usage of the product,
and introduces the product according to the most complete configuration to
ensure that the clinical laboratory technicians engaged in the test successfully
carry out the daily inspection work and record the relevant daily maintenance
contents. Content may not apply to the product you purchased. If you have any
questions, please contact us.
Before using this product, please read and understand the contents of this user
manual to ensure that the product can be used correctly.
The pictures in this user manual are for illustrative purposes only and are for no
other purpose. The actual picture is subject to the product.
This user manual includes the following sections:
Copyright page
Preface
Security Information
Chapter 1 System overview
Chapter 2 Basic operation method
Chapter 3 System setting
Chapter 4 computing method
Chapter 5 Reagent application
Chapter 6 Calibration test
Chapter 7 QC tests
Chapter 8 Sample test
Chapter 9 Data process
Chapter 10 Parameter
Chapter 11 System function
Chapter 12 LIS usage
Chapter 13 Alarm and fault handling
Appendix
Catalogue
Preface .............................................................................................................................................. I
Security information ......................................................................................................................... I
1 System Overview .......................................................................................................................... 2
1.1 Installation requirements and steps ..................................................................................... 3
1.1.1 Installation requirements .......................................................................................... 3
1.1.2 Instrument installation .............................................................................................. 6
1.2 Instrument structure ............................................................................................................ 7
1.2.1 Instrument appearance ............................................................................................. 8
1.2.2 Instrument cover internal structure .......................................................................... 9
1.2.3 Instrument movement structure .............................................................................. 10
1.2.4 Overall structure and function ................................................................................ 11
1.2.5 Reagent & Sample Processing System................................................................... 12
1.2.6 Reaction system ..................................................................................................... 18
1.2.7Washing system ...................................................................................................... 20
1.2.8 Optical Detection System ....................................................................................... 21
1.2.9 Mixing system ........................................................................................................ 22
1.2.10 Operation System ................................................................................................. 23
1.2.11 Data output ........................................................................................................... 23
1.2.12 Accessories&consumable .................................................................................... 23
1.2.13 Data manage software .......................................................................................... 23
1.3 Optional parts .................................................................................................................... 24
1.3.1 Printer ..................................................................................................................... 24
1.3.2 Water purifier ......................................................................................................... 24
1.3.3 Bar code reader installation .................................................................................... 24
1.3.4 IP address configuration ......................................................................................... 25
1.3.5 Power setting .......................................................................................................... 26
1.3.6 Power on ................................................................................................................ 29
1.4 Software introduction&operation...................................................................................... 29
1.4.1 Software interface .................................................................................................. 29
1.4.2 Mouse Usage .......................................................................................................... 33
1.5 System Parameter .............................................................................................................. 33
2 Basic Operation .......................................................................................................................... 36
2.1 Operate chart ....................................................................................................................... 2
2.2 Check before starting .......................................................................................................... 2
2.2.1 Water Checking........................................................................................................ 2
2.2.2 Power Checking ....................................................................................................... 2
2.2.3 Printer Paper checking ............................................................................................. 3
2.2.4 Waster Connection ................................................................................................... 3
2.2.5 Probe Checking ........................................................................................................ 3
2.3 Turn On Analyzer ............................................................................................................... 3
2.3.1 Turn On the power ................................................................................................... 3
2.3.2 Software ................................................................................................................... 4
2.4 Status Confirm .................................................................................................................... 6
2.5 Reagent Preparation ............................................................................................................ 6
2.5.1 Reagent preparation ................................................................................................. 7
2.6 Calibration........................................................................................................................... 9
2.6.1 Calibration Testing ................................................................................................. 10
2.6.2 Calibrator preparation ............................................................................................ 11
2.6.3 Calibration Start ..................................................................................................... 11
2.7 QC ..................................................................................................................................... 12
2.7.1 QC Testing ............................................................................................................. 12
2.7.2 QC Preparation ....................................................................................................... 12
2.7.3 QC Testing Start..................................................................................................... 13
2.8 Sample Testing .................................................................................................................. 13
2.8.1 Normal sample testing............................................................................................ 13
2.8.2 Sample Preparation ................................................................................................ 16
2.8.3 Start Testing ........................................................................................................... 17
2.9 Emergency Sample Testing(STAT) .................................................................................. 17
2.9.1 Emergency Sample Entry ....................................................................................... 17
2.9.2 Emergency Sample Preparation ............................................................................. 19
2.9.3 Testing Start ........................................................................................................... 20
2.10 Testing condition and control.......................................................................................... 20
2.11 Daily Maintenance .......................................................................................................... 22
2.12 Turn Off .......................................................................................................................... 22
2.13 Operation after turn off analyzer ..................................................................................... 23
3 System Setting .............................................................................................................................. 1
3.1System Setting...................................................................................................................... 2
3.1.1 Brief introduction ..................................................................................................... 2
3.1.2Sample information and testing information setting ............................................... 2
3.1.3 LIS settings ...................................................................................................................... 2
3.1.4 User Settings .................................................................................................................... 2
3.2 Item Setting ......................................................................................................................... 2
3.2.2 Parameter Setting ..................................................................................................... 3
3.2.3Judging parameter settings ........................................................................................ 6
3.2.4 Correction factor setting ........................................................................................... 7
3.3 Calibration Setting .............................................................................................................. 7
3.3.1 Introduction .............................................................................................................. 7
3.3.2 Edit calibrators, set calibrator concentration, set calibration mode .......................... 7
3.3.3 Delete calibration ................................................................................................ 9
3.4 QC setting ........................................................................................................................ 9
3.4.1 Introduction .......................................................................................................... 9
3.4.3 Item Selection ..................................................................................................... 10
3.4.4 Set the concentration parameters of QC products ............................................... 11
3.4.5 Set QC Rules ............................................................................................................ 11
3.4.6 Delete the QC ......................................................................................................... 12
4 Calculation Method.................................................................................................................... 13
4.1 Introduction ....................................................................................................................... 14
4.2 Analysis method ................................................................................................................ 14
4.2.1 Brief introduction ................................................................................................... 14
4.3 End point method .............................................................................................................. 15
4.3.2 One point end point method ................................................................................... 16
4.3.3 Two point end point method .................................................................................. 16
4.4 Fixed time method ............................................................................................................ 18
4.4.2 Calculation ............................................................................................................. 18
4.5 Rate method ...................................................................................................................... 20
4.5.2 Calculation ............................................................................................................. 20
4.6 Calibration method ............................................................................................................ 21
4.6.2 linear method.......................................................................................................... 21
4.6.3 Nonlinear method ................................................................................................... 24
4.7 Prozone check ................................................................................................................... 30
4.7.2 Antigen addition method ........................................................................................ 30
4.7.3 Reaction rate ratio method ..................................................................................... 31
5 Reagent application.................................................................................................................... 32
5.1 Overview ........................................................................................................................... 33
5.1.2 Reagent Information Interface Overview ............................................................... 33
5.2 Reagent margin alarm limit setting ................................................................................... 34
5.2.2 Reagent margin alarm limit .................................................................................... 34
5.3 Reagent residue detection ................................................................................................. 34
5.3.2 Detection reagent balance ...................................................................................... 34
5.3.3 Manually refresh the reagent balance..................................................................... 35
5.3.4 Cancel margin detection ......................................................................................... 36
5.3.5 Set the reagent balance to automatically refresh .................................................... 36
5.4 Print reagent information .................................................................................................. 36
5.4.2 Print reagent information ....................................................................................... 36
5.5 Loading reagent................................................................................................................. 37
5.5.2 Reagent registration ............................................................................................... 37
5.5.3 Loading reagent...................................................................................................... 38
5.6 Replacement reagent ......................................................................................................... 38
5.6.2 Replacement reagent .............................................................................................. 39
5.7 Unloading reagent ............................................................................................................. 39
5.7.2 Unloading biochemical reagents ............................................................................ 39
6 Calibration test ........................................................................................................................... 40
6.1 Overview ........................................................................................................................... 41
6.2 Calibration parameter setting ............................................................................................ 41
6.3 Calibration item directory ................................................................................................. 42
6.4 Calibration test .................................................................................................................. 44
6.5 Calibration result confirmation ......................................................................................... 44
6.5.1 View response curve .............................................................................................. 44
6.5.2 Query calibration result .......................................................................................... 46
7 QC test......................................................................................................................................... 47
7.1 Overview ............................................................................................................................. 2
7.2 QC rules setting ................................................................................................................... 2
7.2.1 Brief introduction ..................................................................................................... 2
7.2.2 QC rules setting ........................................................................................................ 2
7.3 QC information login .......................................................................................................... 5
7.4 Quality control item directory ............................................................................................. 6
7.5 Quality control test .............................................................................................................. 7
7.6 QC results confirmation ...................................................................................................... 8
7.6.1 View response curve ................................................................................................ 8
7.6.2 Query QC Result ...................................................................................................... 9
7.6.3 Analysis of out of control ....................................................................................... 11
8 Sample Test................................................................................................................................... 2
8.1 Overview ............................................................................................................................. 2
8.2 Sample Test Method ........................................................................................................... 2
8.2.1 Introduction .............................................................................................................. 2
8.2.2 Sample entry ............................................................................................................ 2
8.2.3 Additional Sample Test ............................................................................................ 3
8.2.4 Modify/ Add Testing Items ...................................................................................... 4
8.2.6 Sample Processing ................................................................................................... 6
Load the sample into the reagent&sample tray. ................................................................ 6
8.3 Cancel Sample Test ............................................................................................................. 7
8.4 Sample Test ......................................................................................................................... 7
9 Data Processing .......................................................................................................................... 12
9.1 Data Output ......................................................................................................................... 2
9.1.1 Introduction .............................................................................................................. 2
9.1.2 Derived Data to LIS Host ......................................................................................... 2
9.1.3 Data Backup ............................................................................................................. 3
9.3 Sample Report Printing ....................................................................................................... 4
9.3.1 Introduction .............................................................................................................. 4
9.3.2 Sample report .......................................................................................................... 4
9.6 QC Report Print .................................................................................................................. 7
9.6.1 Introduction .............................................................................................................. 7
9.6.2 QC Result ................................................................................................................. 7
10 Item Parameters ......................................................................................................................... 8
11 System Function ......................................................................................................................... 4
11.1 User and password settings ............................................................................................... 2
11.1.1 Introduction ............................................................................................................ 2
11.1.2 Adding Users.......................................................................................................... 2
11.1.3 Deleting Users ........................................................................................................ 2
11.1.4 Changing the password .......................................................................................... 3
12 How to Use LIS........................................................................................................................... 4
12.1 Overview ........................................................................................................................... 2
12.3 Sample test connected to LIS ............................................................................................ 2
12.3.1 Introduction ............................................................................................................ 2
12.3.2 Sample Testing Connected to LIS .......................................................................... 3
13 Maintenance ............................................................................................................................... 4
13.1 Overview ........................................................................................................................... 5
13.2 Regular Maintenance ........................................................................................................ 7
13.2.1 Introduction ............................................................................................................ 7
13.3 Daily Maintenance ............................................................................................................ 8
13.3.1 Check reagent&sample probe / stirrer / cleaning needle / cleaning tank ............... 8
13.3.2 Check pure water connection ............................................................................... 10
13.3.3 Check waste connection ....................................................................................... 10
13.4 Weekly Maintenance....................................................................................................... 12
13.4.1 Cleaning reagent&sample probe / cleaning needle / stirrer outer wall ................. 12
13.5 Monthly maintenance ................................................................................................... 14
13.5.1 Cleaning tank ....................................................................................................... 14
13.6 Maintenance every three months............................................................................. 15
13.7 Maintenance every six months ................................................................................ 17
13.8 Unscheduled maintenance ....................................................................................... 20
Steps ................................................................................................................................ 21
14.1 Troubleshooting Methods ....................................................................................... 34
14.1.1 Introduction .......................................................................................................... 34
14.1.2 Observing instrument failure prompt ................................................................... 34
Appendix D: Cross Contamination Reference Sheet ................................................................. 50
Security information
This chapter introduces the safety symbols used in the user manual and their
meanings. It summarizes the safety hazards and precautions when using the
instrument, as well as the labels and specific meanings attached to the
instrument, and lists the components included in the instrument. Whether the
content of toxic or hazardous substances or elements meets relevant
standards.
Safety symbol
Various safety symbols are used in this user manual andchemical analyzer to
remind you of the things you need to be aware of during operation. As shown
in the following table:
Symbol Sign language Description
Used for reagent&sample probes and waste drains.
Biological
indicates a risk of biological infection, and if not
infection risk
followed, there may be a risk of biological infection.
Used for power switch, 220V/110V power supply
Prevent electric
position. indicating the risk of electric shock, if
shock
contact, may cause personal injury.
Used for halogen lamp position. indicates a burn
Prevent burns hazard and may be burnt if contacted or not
followed.
Used to indicate a static-sensitive device or to
Electrostatic
indicate a device or connector that has not been
sensitive device
tested for antistatic.
Used for the position of moving parts such as sample
arm, mixing arm, cleaning mechanism, etc..
Prevent moving
indicating potential danger, the operator must be
parts
trained, if not in accordance with the instructions,
may cause personal injury.
Protective For internal and external grounding. please ensure

grounding that the instrument is well grounded.
Indicates that the transport package should be

Up
vertically up when transported.
Indicates that the transport package contains fragile

Fragile items
items and should be handled with care.
It indicates that the transport package is afraid of

Afraid of rain
rain.
Indicates that the shipping package cannot be rolled

No rollover
during handling.
Don‘t stack Indicates that the package can only be placed in a

code single layer.
Safety precautions
For use of this instrument safely, please read the following safety precautions
carefully. Any operation that violates the following safety precautions may
result in personal injury or damage to the instrument.
Warning:
In all cases marked with this warning sign, the user manual is required to
clarify the nature of the potential hazard and any countermeasures that must
be taken. If you do not follow the instructions in this user manual, the
protective measures provided by this instrument may be invalid.
Biological infection risk:

 Improper use of the sample may result in infection. Do not touch
samples, controls, calibrators, mixtures, and waste directly with your
hands. Always wear gloves, work clothes to prevent infection, and wear
protective glasses if necessary.
 If the sample is inadvertently in contact with the skin, please follow the
user's work standards immediately and consult a doctor.
Prevent electric shock:

 Unauthorized customer service engineers must not open the back cover
and side cover when the main power is turned on.
 Reagents and samples spill onto the instrument, which can cause
instrument malfunction and electric shock. Do not place samples and
reagents on the instrument. If splashing occurs, please turn off the power
immediately and contact Shandong Biobase Biotech Co., Ltd
Prevent moving parts from causing personal injury:

 When the instrument is working, there is a potential danger. The operator
must be professionally trained and must follow the instructions to ensure
operation in a safe area.
 Do not touch the moving parts of the instrument while the instrument is
in operation. Moving parts include sample arm, stirring arm, cleaning
mechanism, reagent&sample tray, reaction tray, etc.
 Do not put your fingers or hands into open parts while the instrument is
working.
Prevent burns:
 Do not touch the light source after the system is turned on.
 When replacing the halogen lamp, the lamp must be replaced after the
power is turned off, otherwise the high temperature halogen lamp and
the light source box may cause burns.
Prevent light sources from causing personal injury:

 When working with the instrument, please do not look directly at the
light source or the light beam emitted by the barcode scanner. These
beams will cause eye damage.
 Before checking the light source, disconnect the analyzer from the mains
and wait at least 15 minutes until the light source cools. Do not touch the
light source before it cools down to avoid burns.
Chemical danger protection:

Some reagents may damage the skin. Please use the reagents carefully to
prevent direct contact between hands and clothing. If you accidentally touch
your hands or clothes, rinse immediately with soap and water. If you
accidentally get into the eyes, rinse immediately with plenty of water and
consult an ophthalmologist.
Waste treatment:
 Some substances in reagents, controls, calibrators, cleaning fluids, and
waste liquids are subject to pollution regulations and emission standards.
Please comply with local emission standards and consult the relevant
reagent manufacturer or distributor.
 When handling waste, be sure to wear gloves, wear overalls to prevent
infection, and wear protective glasses if necessary.
Prevent fires and explosions:
Alcohol is flammable and must be used with great care.
Processing instrument:
Some substances in discarded instruments are subject to pollution regulations.
Dispose of used instruments in accordance with local waste disposal
standards.
Device is out of service:

During the process of equipment maintenance, transportation or handling,
please clean and disinfect the surface of the instrument and the reagents such
as reagent&sample probes, reagent&sample probes, stirrer, etc., and remind
the relevant personnel of the risks of the instruments to avoid handling or
Biological risks or other hazards during maintenance.
Operational precautions
Instrument use
Warning:
This instrument is used to quantitatively analyze the clinical chemistry of
serum, plasma, urine, cerebrospinal fluid and other samples.
When considering clinical results based on the results of the analysis, please
consider clinical symptoms or other test results.
Use environment
Be careful:
 The electromagnetic environment should be evaluated before operating
the equipment.
 Please install the instrument correctly according to the installation
environment specified in the user manual. Do not place the device in a
location where it is difficult to operate the disconnect device. Installation
and use of this instrument outside of the specified conditions may result
in unreliable results and may result in damage to the instrument.
 If you need to change the system status, please contact the company's
customer service center or distributor in your area.
System installation
Warning:
This product is a permanently connected device that uses switches and circuit
breakers as disconnect devices. In order not to affect the normal operation of
the instrument, before installation, ensure that the building in the installation
location is equipped with a switch or circuit breaker that meets the
requirements of GB4793.1-2007 as the disconnect device. The switch or
circuit breaker in the building should clearly indicate that the switch or
circuit breaker is the disconnect device of the instrument.
Prevent electromagnetic waves and noise
Be careful:
 Do not place equipment that emits abnormal noise near the instrument.
Please turn off the equipment that emits electromagnetic waves, such as
cell phones, radio transceivers, etc., in the room where the instrument is
located, and do not use other CRT monitors near the instrument. Noise
and electromagnetic interference may cause instrument malfunction.
 Do not use other medical instruments near this instrument.
Electromagnetic waves emitted by this instrument may cause
malfunction of other medical instruments in the vicinity.
Instrument use
Be careful:
 Please follow the instructions in the user manual to use the instrument.
Improper use may result in inaccurate measurements and may even
result in damage to the instrument or personal injury.
 Before using the instrument for the first time, please set the calibration
and then carry out QC to confirm that the instrument is working
properly.
 When using the instrument, QC procedures must be performed,
otherwise the reliability of the results cannot be guaranteed.
 Do not open the sample/reagent cover during the analysis
 The network port of the analyzer is set to be connected to the network
port of the computer. Do not connect to cables other than any other
device. Please use the dedicated cable provided by the company to
connect the analyzer to the computer.
 The computer is a platform for operating the instrument-specific
operating software. Installing any software or hardware other than the
company's designated content on this computer may prevent the
instrument from functioning properly. Do not run other software while
the instrument is in operation.
 Computer viruses can destroy software and data. Please do not use your
computer for other purposes or to connect to the Internet.
 Do not touch your computer's monitor, mouse, or keyboard with wet or
chemically-friendly hands.
 Do not turn the power switch back on within 10 seconds of turning off
the analyzer's total power, otherwise the instrument may enter protection.
If the instrument enters the protection status, please turn it off and then
turn it on again.
Instrument maintenance:
Be careful:
 Follow the instructions in the user manual to maintain the instrument.
Improper maintenance may result in incorrect analysis and may even
result in damage to the instrument or personal injury.
 The instrument may be placed for a long time and may have dust on the
surface. When cleaning, use a clean soft cloth soaked in water, wring it
out gently, and if necessary, dip a small amount of soap. Do not use
organic solvents such as alcohol. After cleaning, dry the surface with a
dry cloth.
 Before cleaning, please turn off all power to the instrument and unplug
the power cord. During the cleaning process, take necessary measures to
prevent water droplets from entering the instrument, otherwise the
instrument may be damaged or personal injury.
 Check the main components, such as replacement of halogen lamps,
reagent&sample probes, stirrer, and injection components, and
calibration analysis must be performed.
 If the instrument needs to be repaired due to malfunction, please contact
company customer service center. During maintenance, the instrument
may need to be taken out of service or transported. Please be careful to
avoid biological hazards, electric shock hazards, and moving parts
hazards due to maintenance.
 When replacing the light source lamp, it is necessary to wait for more
than 20 minutes after the power is turned off to perform the lamp
replacement operation. Otherwise, the high temperature light source
lamp and the light source box may cause burns.
Parameter settings
Be careful:
The instrument needs to set parameters such as sample size, reagent amount,
and measurement wavelength. When setting these parameters, please follow
the instructions in the user manual and refer to the instructions provided with
the reagents.
Sample
Be careful:
 Use a complete serum sample and a urine sample that does not contain
suspended solids. If the serum sample contains fibrin, or if the urine
sample contains insoluble impurities such as suspended solids, it may
block the reagent&sample probe and affect the analysis results.
 Drugs, anticoagulants, preservatives, etc. present in the sample may
interfere with certain analytical results
 Hemolysis, jaundice, chylomicron, etc. in the sample may affect the
analysis results. It is recommended to do a sample blank test.
 Please use the correct sample storage measures. Improper sample storage
measures may alter the composition of the sample and result in incorrect
analysis results.
 To prevent the sample from evaporating, do not leave the sample open
for a long time. If the sample evaporates, it may result in incorrect
analysis results.
 Some samples may not be analyzed based on test parameters and
reagents used. For these samples, please consult the reagent
manufacturer or distributor and the distributor of Shandong Biobase
Biotech Co., Ltd
 The sampling quantity is required for the analysis of this instrument.
When sampling, determine the appropriate sample size according to the
instructions in this user manual.
 Before analyzing, please confirm that the sample is placed in the correct
sample position, otherwise you may not get the correct result.
Reagents, calibrators, QC products
Be careful:
 When using this instrument for analysis, you need appropriate reagents,
calibrators, and controls.
 Please select the matching reagent according to this instrument. If you
are not sure if the reagent is available, please consult your company or
company's distributor.
 Reagents, calibrators, use and storage of QC products, etc., please follow
the instructions of the relevant reagent manufacturer or distributor.
 If the reagents, calibrators, and controls are not properly stored, even
within the validity period, the correct test results and the best instrument
performance may not be obtained.
 After checking the reagents, please perform calibration analysis. Without
calibration analysis, the correct analysis results may not be obtained.
 During analysis, cross-contamination of reagents may affect the results
of the analysis. Consult reagent manufacturers or companies for reagent
cross-contamination information.
Data backup
Note:
The instrument has the function of automatically storing data on the
computer's hard disk, but the computer hard disk data is deleted or the hard
disk is damaged due to other reasons, which may result in data being
unrecoverable. Please periodically back up the analysis data and
measurement parameters to other mobile storage devices.
Computer and printer
Note:
Please refer to the instructions for use of the computer and printer.
Use hoses or parts with liquids

Warning:
If any hose or liquid-filled parts are aging or worn during use, please stop
using them immediately and contact customer service engineers for
inspection or replacement.
System Overview
1 System Overview
This chapter provides a detailed introduction to the instrument in terms of

installation, hardware, software, and specifications. It mainly includes the
following:
 Instrument installation requirements and methods
 Hardware system structure
 Optional module
 Software interface introduction and use
 System specification
System Overview-2
System Overview
1.1 Installation requirements and steps

1.1.1 Installation requirements
Instrument installation example is as follows:
The distance between the analyzer and the wall should be not less than 500mm.
The distance between the rear panel of the analyzer and the wall should be not
less than 500mm.
The distance between the front of the analyzer and other instruments is not less
than 1000mm.
Guarantee the space for the waste liquid device and the pure water supply
device during installation.
UPS
Power supply: AC220V/110V, Waste barrel

50Hz/60Hz.
Power: 750VA.
The instrument is equipped with a
three-core power cord, red for
fire, blue for zero, yellow green
for ground.
Outlet
Display: 17 inches or more,

resolution no less than 1280 x 1024.
Voltage regulator
Computer host: CPU frequency≥2.8GHz，hard disk

80G or above, memory≥2GB, TCP/IP internet, RS-232,
USB2.0 port.
Software system: Windows 7/8/10 or above. Printer
The connecting line in the figure indicates the corresponding pipe or wire.
1.1.1.1 Installation space requirements

System Overview-3
System Overview
In order to facilitate the operation, maintenance and repair of the instrument, the
Auto chemical analyzer must meet the following conditions during installation:
 The distance between the left and right sides of the instrument and the wall
should be no less than 500mm.
 The distance between the rear panel and the wall of the instrument should be
no less than 500mm.
 The distance between the front of the instrument and other instruments
should be no less than 1000mm.
 Guarantee the space for the waste liquid device and the pure water supply
device during installation.
Minimum distance 500mm
Computer
425
Analyzer
Minimum distance 1000mm
Front
mm
1.1.1.2 Power requirements and protective grounding

Power supply: AC220V/AC110V, 50Hz/60Hz
Instrument power: 300VA
The power socket used in this instrument needs to be well grounded. (At least
three 5A sockets should be available), heavy-duty electrical equipment such as air
conditioners, refrigerators, and ovens should not be used in the same socket as
this instrument.
The grounding bolt is located on the L-frame of the rear panel. Please connect the
grounding wire. The protective grounding must be good. See figure 1-3.
System Overview-4
System Overview
Figure 1-3
Warning:
Protective grounding must be good to prevent electric shock and instrument
failure
1.1.1.3 Electromagnetic compatibility requirements
BK-200mini auto chemical analyzer radiation emission, conducted emission

should meet the requirements of GB4824 group 1 class A, the immunity
requirements meet the requirements of table 1-1.
It is the responsibility of the user to ensure that the equipment is in an
electromagnetic compatibility environment so that the equipment can work
properly. It is recommended to evaluate the electromagnetic environment before
the equipment is used.
Auto chemical analyzer using reagent&sample probe is an important part of
liquid level detection function, sensitive to electrostatic discharge.
Reagent&sample probe tip for antistatic discharge coating, reagent&sample
probe body mounting shield. Prevent direct contact between hands and clothing.
 BK-200mini auto chemical analyzer is designed and tested according to class
A equipment in GB4824. In a domestic environment, this device may cause radio
interference and protective measures may be required.
 Do not use the device near strong radiation sources (such as unshielded RF
sources), as this may interfere with normal operation of the device.
Table 1-1 Immunity requirements
1.1.1.4 Environmental requirements

The ambient temperature of the instrument is 15 ℃ ～ 30 ℃.
Relative humidity is 40% to 85%
Atmospheric pressure is 86.0kPa ~ 106.0kPa
BIOBASE series Auto chemical analyzer is only used indoors, the environment
should be dust-free, no mechanical vibration, no loud noise source and power
supply interference.
The ground should be level and the ground bearing capacity should meet 100 kg
per square meter.
Do not get close to brush generators, flashing fluorescent lamps, and contact
devices that are frequently switched
Avoid direct sunlight or place in front of heat sources and sources.
Keep the instrument well ventilated
Ensure that the instrument is well grounded
Warning:
The accuracy of normal operation and test data cannot be guaranteed for the
instrument in environments other than those described above. If the
System Overview-5
System Overview
temperature and humidity do not meet the above requirements, please use air
conditioning equipment and humidification equipment.
The instrument generates heat during operation and is discharged through the
rear of the instrument. The working environment should be well ventilated
and ventilation equipment should be used if necessary. However, airflow
should be avoided to blow directly to the instrument, otherwise it may affect
the accuracy of the instrument test.
1.1.1.5 Water supply and drainage

The instrument must meet the following water and drainage requirements before
delivery:
The instrument needs to use deionized water, the conductivity is below 1μs/cm,
and the instrument water consumption is 4L/hour. It is recommended to choose a
water machine of about 15L.
Warning:
The water quality must meet the water supply requirements. Otherwise,
insufficient water purity may affect the test results.
Ensure that the water supply hole and pipeline installation of the instrument
should be kept unobstructed. In addition, the inlet of the L-frame of the
instrument should be higher than the pure water bucket, and the height difference
from the liquid level of the feed water should be less than 50cm.
Ensure that the drainage hole and pipeline installation of the instrument should be
kept unobstructed, and the outlet of the instrument L frame should be higher than
the waste liquid barrel mouth (or special discharge port for waste liquid), and the
length of the waste pipe should not exceed 2m.

Dispose of the waste liquid from the instrument in accordance with local
discharge standards. When installing the drain line, be sure to wear gloves,
wear overalls to prevent infection, and wear protective glasses if necessary.
1.1.2 Instrument installation
Warning:
In order to ensure the normal operation of the instrument after installation,
the installation and initial setting of the instrument , pls contact us.
1.1.2.1 Unpacking step
System Overview-6
System Overview
After the instrument arrives, please check the packaging of the instrument
carefully to see if there is physical damage. If there is any damage, please contact
BIOBASE agent . After confirming that there is no external damage, follow the
steps below to unpack:
 Erect the arrow on the box upright.
 Open the accessory box and check whether the object is complete according
to the packing list. If there is any missing, please contact BIOBASE
company or local agent
 Check the appearance of the instrument carefully. If there is any damage,
please contact BIOBASE company directly.
Figure 1-4 Unpacking
1.1.2.2 Handling method

 Ensure that the appearance of the instrument is intact and that all parts are
intact before handling
 All moving and transporting processes must be kept upright and not tilted or
placed sideways.
 Vibration should be avoided during handling. It should be inspected and
debugged after handling.
1.2 Instrument structure

The internal structure of BK-200mini Auto chemical analyzer adopts the scheme
of “two trays + one probe + one stirrer, a reaction tray, a reagent&sample tray, a
reagent&sample probe, and a stirrer. A reagent&sample probe is used to fill the
sample, R1 reagent and R2 reagent, and a stirrer is used for reagent stirring and
sample stirring. The optical measuring mechanism performs real-time
photoelectric acquisition of the reaction cup by means of post-split mode. The
Auto cleaning mechanism is responsible for the Auto cleaning of the cuvette
during the test.
System Overview-7
System Overview
1.2.1 Instrument appearance

1
2 4
1
5
10
3
6 7 8
Figure 1-5 Front view Figure 1-6 Right view
11 13 12
14
1
15
1 16
Figure 1-7 Rear view
Item Name Note
1 Top cover Protection loading system, detection unit, sample tray
System Overview-8
System Overview
Item Name Note
and reagent tray
2 Observation window Here you can observe the working conditions of the
internal sample loading system, detection unit, etc.
3 Front panel Use when maintaining the instrument
4 Right side panel The power switch is located on the right side panel
5 Power Board Turn the power and power cord connections on or off
6 Master power supply Instrument main control power switch
7 Refrigeration power supply Power switch for the cooling section
8 Switch Equipment operation switch
9 Fuse Safe operation of the protection circuit
10 Power input connector Used to power the device
11 Communication Interface Connect the analyzer to the computer
12 L frame Connected ground wire, pure water wastewater alarm,

water connection
13 Grounding bolt Connecting ground
14 Aviation joint Connect pure water and waste liquid float level switch
to realize pure water and waste liquid alarm
15 Outlet Connect the snake skin tube and drain the waste liquid
16 water intake Connect polyurethane hose to provide pure water for

the instrument
1.2.2 Instrument cover internal structure

3
5 2
2 4
System Overview-9
System Overview
Figure 1-8
Item Name Note
1 Reagent&sample tray Place reagent bottles, sample cups, blood collection

tubes, centrifuge tubes, etc.
2 purge tank Cleaning reagent&sample probe or stirrer
3 Loading system Aspirate reagents and samples from the

reagent&sample tray and dispense them into the
reaction cup of the reaction system
4 Mixing system Stir the reagent and sample mixture in the cuvette
5 Reaction system The reaction cup is fixed and the inside is kept at a
fixed temperature to provide reaction conditions
6 Cleaning system cleaning the cuvette
1.2.3 Instrument movement structure
1 2 3 4 5 6 7 8 9
10 11 12 13 14 15 16
Figure 1-9
1-Piston pump.2-Cleaning arm.3-L frame .4-Reaction tray.5-Sample arm.6-purge

tank1.7-Reagent&sample tray.8-Circuit board assembly.9-Power Board.10-Miniature
diaphragm pump.11-The electromagnetic valve.12-Halogen lamp.13-Optical path
component.14.purge tank2.15-Mixing arm.16power box.
System Overview-10
System Overview
The structure of the instrument movement is mainly composed of a

reagent&sample tray, a sample loading system, a reaction system, a stirring
system, a cleaning system, a refrigeration system, an optical detection system, a
liquid path system, and an alarm system.
1.2.4 Overall structure and function

The auto chemical analyzer consists of an analysis unit, an operation unit
(computer system), a result output unit (printer), accessories, and consumables.
The analysis department is the analyzer host, which is mainly used to analyze
samples, measure clinical chemistry of various samples, and generate result data.
The analysis department is mainly composed of the following components:
 Sample & Reagent processing system
 Reaction system
 Cleaning system
 Optical inspection system
 Mixing system
The operation department is a computer equipped with Auto chemical analyzer
operation software to complete test application, test, reaction process monitoring,
result calculation, data input, storage and query, etc.
The output is a printer that is used to test the printout of results and other data.
Accessories and consumables include cuvettes, light sources, etc.
The overall structure is connected as shown:
Display: 17 inches or more, Printer

resolution no less than 1280 x 1024.
Computer host: CPU frequency≥2.8GHz，hard disk 80G or

above, memory≥2GB, TCP/IP internet, RS-232, USB2.0 port.
Software system: Windows 7/8/10 or above.
Analyzer
Figure 1-10
System Overview-11
System Overview
1.2.5 Reagent & Sample Processing System

The reagent & sample processing system is used to load reagents and samples,
and each sample (reagent) is sent to the aspirating site (aspirating reagent site) to
take a sample (reagent), and then injected into the reaction cup to react with the
reagent (sample). Optical detection system measures the absorbance of the
reaction solution
The reagent & sample processing system is mainly composed of the following
components:
 Reagent & Sample tray assembly
 Cooling System
 Loading system
 Sample tube
 Reagent bottle
 Reagent barcode scanning component
1.2.5.1 Reagent&sample tray assembly

1
Figure 1-11
1-Sample position.2-Reagent circle
The reagent&sample tray is divided into sample position and reagent circle, and
the sample position is 37，The standard cup containing the sample, calibrator, and
control can be placed in the set position，the reagent&sample tray is rotated and
sent to the sample arm for the reagent and sample position.
2
3
Figure 1-12
System Overview-12
System Overview
1-Reagent&sample tray.2-heat sink.3-Cooling fan
1
3
2 4
Figure 1-13
1-Reagent&sample tray positioning plate.2-motor. 3-Reagent&sample disk axis,
4-Reagent&sample tray fixed base.
2 3
Figure 1-14
1-Reagent&sample tray, 2-Reagent&sample tray circle-, 3-Reagent&sample tray upper
ring bracket, 4-Reagent&sample tray handle
As shown in 1-12, 1-13,1-14，The reagent&sample tray is composed of a fixed

base, an outer frame, a disk shaft, a positioning plate, a driving motor, a
reagent&sample tray, a handle, and the like.
When the instrument is energized, the drive motor drives the pulley to rotate,
causing position 1 to rotate to the reagent or sample position. During the sample
test, the drive motor drives the reagent&sample tray to rotate, and rotates the edit
sample number or reagent position to the sample or reagent position. At the time
of initialization, the same action as power-on.
The reagent&sample tray guide pin must be aligned during installation so that the
reagent&sample tray is flat, and there is no slip when gently rotated by hand, and
then the reagent&sample tray handle is tightened. When disassembling, first
unscrew the handle counterclockwise and lift the reagent&sample tray directly.
When detecting motion, find the “Instrument Detection” function in the
dedicated software of this instrument, input the target value in “Target Bit”, and
System Overview-13
System Overview
click “Y” to execute the detection. "Return to zero" means returning to the
initial position.
1.2.5.2 Cooling System

The reagent&sample tray is the core component of the refrigeration system.
Reagent&sample tray refrigeration assembly includes semiconductor
refrigeration chip, heat sink, cooling fan.
Reagent try frame
Reagent incubator
Semiconductor
refrigeration chip
Heat sink
Cooling fan
Figure 1-15
The semiconductor refrigerating sheet has two faces, hot and cold. When
installing, pay attention to distinguishing different faces.
The main component of the refrigeration control system is the reagent&sample
tray. The sample reagent tray is kept at a low temperature for 24 hours through a
cooling tray, a cooling fan, and a heat sink.
1.2.5.3 Loading system

The sample loading system consists of a sample arm, a plunger pump and a
solenoid valve, controlled by a solenoid valve and a plunger pump.
System Overview-14
System Overview
Sample arm Reagent&sample pump

Figure 1-16
The sample arm is composed of a reagent&sample probe, a cross arm, a ball

spline shaft, a drive motor, a photoelectric switch, and the like.
2
7
3
8
4
9
10
11
12
5
Figure 1-17
1-Reagent&sample probe cover.2-Ball spline shaft.3-Sample arm main frame.4-Left and
right stepper motor.5-Adapter plate.6-Upper and lower stepper
motor.7-Reagent&sample probe-.8-Left and right timing belt.9-Up and down timing
belt.10-Bearing compression sleeve.11-Pipe clamp.12-Move up and down
Sample arm has the function of adding sample and adding reagent.
The sample loading function of the sample arm is to take a set amount of sample
from the sample cup and then fill it into the reaction cup. The sample is sampled
at a dose of 2μl to 70μl with an accuracy of 0.1μl. At the same time of
sampling, the reagent&sample probe will open the liquid level detection function
System Overview-15
System Overview
to detect a sample size of 50μl, and the minimum test sample size is 50μl or
more.
The reagent loading function of the sample arm is to take a set amount of reagent
from the reagent bottle and add it to the reaction cup. At the same time, the
reagent&sample probe opens the liquid level sensing function. The remaining
amount of the reagent is calculated by the distance the reagent&sample probe is
dropped, and the remaining amount of the reagent is displayed in the "Reagent
Information" window. As shown in figure 1-18.
Figure 1-18
During reagent sampling, to prevent the reagent from being diluted, at each time
aspirate the reagent. Reagent&sample probes are drawn according to the "set
amount + balance", only the set amount of reagent when adding reagent to the
reaction cup. The reagent setting amount ranges from 20 μl to 350 μl and can
be set in units of 1μl.
The liquid level detection function of the reagent&sample probe can detect the
remaining amount of the sample or reagent. Auto collision protection is activated
when a similar collision occurs during the descent. The reagent&sample probe
returns to the highest position in the vertical direction and no longer drops.
Anti-collision protection can only be resumed by power-off, and then reset after
power-on reset. After restarting, it is necessary to re-adjust the mechanical
position of the reagent&sample probe, and thoroughly check the instrument
without any problem before starting the test again.
When performing the sample test, the reagent&sample probe is sequentially
moved in the order of "sample cup (or reagent bottle), reaction cup,
reagent&sample probe cleaning tank".
Warning:
System Overview-16
System Overview
When the system is running, do not place any hand or other parts of the body
on the path of the sample arm or place any obstacles on the path of the
sample arm. Failure to do so may result in personal injury or system damage.
Click software‖ ‖, The initialization process is the same as the power-on

process.
During the sampling process of the sample arm, the reagent&sample probe first
detects the liquid level and then continues to descend to a certain height to absorb
the sample or reagent.
In the motion detection, find the sample arm in the "instrument detection"
function in the instrument-specific software. As shown 1-19. Rotate the
reagent&sample tray and the reaction disk to a certain number, and click the
function keys of the sample arm in the software to check the cleaning position,
the sample or reagent level, the vertical position of the sample or reagent, and the
reaction cup position.
Nut
Up fixed screw
Spring
Adapter sleeve
Anti-collision base
Figure 1-19 Figure 1-20
As shown in the 1-20, Reagent&sample probe assembly includes anti-collision

probe holder, clamping sleeve, spring, upper fixing wire and nut.
1.2.5.4 Sample tube
The sample tube is used to hold the sample. Reagent&sample trays support
different sample tube types. Sample bits support the following sample container
types:
 Micro sample cup:Φ12×37mm, 2ml
 Original blood collection tube or plastic test tube:Φ12×68.5mm, Φ
12.7×75mm, Φ13×75mm.
System Overview
Sample tubes with different specifications, the minimum sample size required is
also different, the minimum sample size per sample tube must be guaranteed,
otherwise
System Overview-17
System Overview
may cause aspiration error. If the sample size is less than the dead volume,
transfer the sample to a small sample tube before testing. The minimum sample
size of the sample tube is the sample size required for the test.
The dead volume of each sample tube is shown in the following table.
Sample container Specification Dead volume
Sample cup Φ12×37mm, 2ml 50ul
Original blood collection Φ12×68.5 mm Higher than the
tube/Plastic test tube Φ12.7×75 mm unavailable sample
Φ13×75 mm 8mm
1.2.5.5 Reagent Bottle

20ml&50ml reagent bottle both available. One reagent position can put only one
reagent bottle. Specification and unavailable volume is listed below
Table 1-3 Specification and death volume
Specification Unavailable volume
20ml 2ml
50ml 3ml
Please prepare enough reagents according to the unavailable volume information
above.
1.2.5.6 Reagent Bar Code Scanner
Reagent bar code scan system consist of listed parts
Reagent bar code scanner
Reagent bar code
Software for reagent scan system
Using the bar code scanner to scan the bar code in reagent bottle, the information
of reagents will display in system, after put the reagent into right position, please
put the reagent tray cover back.,
Warning
The beam from bar code scanner may damage the light, Do not look directly at
the beam from the reagent barcode scanner.
1.2.6 Reaction system

Reaction system included reaction tray, reaction tray cover, reaction cuvettes,
reaction thermostat.
Whole system like figure 1-22
Reaction cup positioning plate: The reaction tray is controlled to rotate and move
by a step motor. Reaction cuvette: the colorimetric cuvettes, total 48 units, can be
replaced independently, using UV-permeable organic plastic.
Reaction cuvettes combination: a total of 6 joints, 8 reaction cups are installed on
each joint, and fixed to the reaction cup positioning plate by 1 screw, as shown in
Figure 1-23.
Thermostat: The air is pre-warmed to allow the sample to react with the reagent
in a 37 ℃ thermostat while temperature monitoring is performed by a
temperature control system.
System Overview-18
System Overview
Figure 1-22 Reaction Tray
5
1
3
4
1-Reaction cuvette position, 2-Identification film, 3-Gland, 4-Cuvette joint, 5-Cuvette
Figure 1-23 Top cover assembly
1-Fiber fixing hole, 2-Column

Figure 1-24 Up part of reaction Tray
System Overview-19
System Overview
1 5
2
3 6
1-Photoelectric switch, 2-Big Gear, 3-Fixed Base, 4-Axis, 5-Small Gear, 6-Step Motor
Figure 1-25 Base part of reaction tray
As figure 1-22, 1-23, 1-24, 1-25 display, reaction tray included up cover, tray,
step motor, drive motor, axis fix part, fiber fix board., etc.
After the power on, the reaction tray rotates counterclockwise, and the probe is
rotated until the reagent&sample probe can swing to the position of the reaction
cup to the 1st position.
The cuvette can be recycled for holding the reaction solution. After each test, the
system Automatically 4-steps cleans and dries the cuvette for the next test.
1.2.7Washing system
1 6
7
8
2 9
3
4 10
11
5
12
1-Washing Probe, 2-Linear guide slider mount, 3-Photoelectric switch, 4-Step motor,
5-Base of washing arm, 6-Compression screw for washing probe,
7-Fixed axis of washing probe, 8-Driven wheel, 9-Driven belt,
10-Up and down wheel, 11-Motor fixed board, 12-Fixed column.
Figure 1-26 Structure of Washing System
System Overview-20
System Overview
When the power is turned on, the cleaning arm first rises to the zero position,
then vertically descends to the reaction cup, cleans the reaction cup, and after
rising, rises and stops above the reaction cup.
The reaction cup automatic cleaning system uses a cleaning agent and deionized
water to perform a 4-step automatic cleaning of the reaction cup to ensure that the
reaction cup is free from cross-contamination and drying during the test. The
process of 4-step cleaning is as follows:
First, second and third step cleaning: wash the cuvette with deionized water and
blot the cuvette
Fourth step cleaning: wiping the reaction cup
After the washing is completed, the washing waste liquid is discharged through
two stages: high concentration waste liquid and low concentration waste liquid.
The system supports the high-concentration cleaning waste liquid level detection
function. When the waste liquid of the high-concentration waste liquid tank is
detected exceeds a certain amount, an alarm is issued, prompting to empty the
waste liquid tank.
For system checking, click the ―Instrument check‖, and select the ―Cleaning
Arm‖ –―Lift Y‖ function to check it the cleaning needle in right positions
1.2.8 Optical Detection System

The optical detection system is located inside the analyzer and is used to measure
the absorbance of the reaction solution in the cuvette. The subsystem consists of
an optical system and a signal detection system. Its main function is to detect the
change of light intensity through the reactants, and to convert the optical change
signal caused by the chemical reaction into an electrical signal by means of
photoelectric conversion, and to detect the electrical signal. The amount of
change reflects the amount of change in light intensity. The working principle
diagram is shown in figure 1-27.
The optical path system uses post-split technology with a wavelength range of
340 to 800 nm, enabling simultaneous detection of dual wavelengths.
Cuvettes
Optical signal
Light source detection
Figure 1-27 Optical Detection System
The optical system consists of a light source, a colorimetric system, and a
spectroscopic component to provide monochromatic light of sufficient intensity
and a stable and reliable colorimetric optical path structure.
System Overview-21
System Overview
The signal detection system includes a photoelectric conversion portion and an

AD acquisition processing portion. Its main function is to convert the light
intensity signal of the monochromatic light focused on the photoelectric
conversion device after being absorbed by the reaction product into an electric
signal, and after the electric signal is amplified, the photoelectric data reflecting
the light intensity is output after being collected by the A/D. And transmitted to
the corresponding control unit for absorbance calculation.
Technical parameter is as below:

Table 1-4 Optical detection system technical parameter
Name Value
Light Source 6V/10W Halogen Lamp
Colorimetric Cuvette
Spectroscopic Beam Splitter
Spectroscopic Post Splitting
Method
Detector Photodiode Array
Wavelength 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm,
700nm
Accuracy ±1nm
Abs Range 0～3.3A
Spectral Width (FWHM) ≤10nm
1.2.9 Mixing system

The mixing system includes a mixing arm and a stirrer assembly. The arm is
substantially identical in structure to the sample arm, except for the components:
the reagent&sample probe assembly and the stirrer assembly.
The mixer arm includes a driving motor, a photoelectric switch, a size pulley, a
ball spline shaft.
1
6
2
8
3
4 9
5
1-Probe Cover, 2-Stirrer, 3-Up&Down Base.4-Up&Down Pulley, 5-Main Support,
6-Ball Spline Shaft, 7-Left&Right Pulley, 8-Left&Right Motor, 9-Up&Down Motor
Figure 1-28 Structure of mixing arm
System Overview-22
System Overview
After the power is turned on, the stirrer rises vertically, swings left and right,
stops above the cleaning position, and then vertically descends to the cleaning
tank for cleaning. After completion, it rises and stops above the cleaning tank.
The initialization process is the same as the motion status after power-on.
During the sample test, the mixer arm is vertically lowered to the cleaning
position for cleaning, and then swinged to the corresponding reaction cup of the
reaction tray to stir the solution.
1.2.10 Operation System

The operation system is composed of computer, display, keyboard, mouse,
printer., etc
Operating system: Windows 7 and above, 32-bit or 64-bit. Microsoft Network
Framework 3.5 and analytics software have been installed. It is recommended to
install the Microsoft Office Access software.
Computer configuration: Must be a brand machine, CPU frequency≥2.80GHz,
hard disk≥80G, memory≥2G.
Display: 17 inches and above, at least not less than 1280*1024 resolution.
Printer: Inkjet or laser printer, print test report.
Mouse: Complete the software operation.
Keyboard: Ability to edit the analyzer's features.
1.2.11 Data output

The output is a printer that prints test results and other data. The instrument
supports inkjet printers and laser printers. The printer is not a standard
configuration. If you need to choose the option, please contact our customer
service department. If you need to purchase it separately, please make sure to
purchase the printer that meets the requirements.
1.2.12 Accessories&consumable
Accessories and consumables refer to the components necessary for the
instrument to perform the sample test. Always check to ensure that the quantity is
sufficient and replenish and replace if necessary. To ensure personal safety and to
ensure system performance, please use accessories and consumables
manufactured or recommended by the company. If necessary, please contact our
customer service department or distributor in your area.
For details on accessories and consumables, refer to "13.1.2 Accessories
Information" (page 2).
1.2.13 Data manage software

As a unified processing platform for analyzer test data, data management
software can meet the needs of daily data processing in the laboratory, supporting
connection requests of multiple instruments at the same time. As a data
management center, it has an independent local database, provides data support
System Overview-23
System Overview
for applications from clients (such as inspection doctors, instruments, system

administrators, etc.), and has daily management of result data. And print function.
The data management software is standard. If you do not need to configure it,
please contact our customer service department.
The LIS functions mentioned in this manual apply to both the data management
software for the indicator and the existing LIS (Laboratory Information System)
system, as the case may be.
1.3 Optional parts

The optional module refers to the part of the instrument that is not part of the
standard configuration when it leaves the factory. If necessary, you can choose
according to the actual situation. The system supports the following optional
modules:
 Printer
 Water Purifier
 LIS system
1.3.1 Printer
Used to print test results and other data. The instrument supports any of inkjet
printers and laser printers. The printer is not a standard configuration. If you need
to choose the option, please contact our customer service department. If you need
to purchase it separately, please make sure to purchase the printer that meets the
requirements.
Before using the operating software for printing, check as follows:
1) Check whether the printer driver is installed.
2) Check whether the data cable connection between the printer and the
analyzer is correct.
3) Verify the printer put into the appropriate printing paper. Switch on the
printer, and start printing.
1.3.2 Water purifier

The water purifier is used to supply pure water to the chemical analyzer. Ensure
that pure water is required for biochemical testing.
Always turn on the water main power switch before starting the test every day.
After completing the test every day, it is recommended to turn off the water
purifier
1.3.3 Bar code reader installation

BIOBASE series auto chemistry analyzer reagents are divided into two types:
closed and open. Closed type requires the installation of a scanner; open type
does not require a scanner.
System Overview-24
System Overview
BIOBASE series auto chemistry analyzer and scanner are all used the USB
interface.
1.3.4 IP address configuration

IP address setting steps are as follows:
Step 1: Right-click the lower right corner of the computer ― ‖ tool, click ―Open
Network and Sharing Center‖, as shown below:
Figure 1-29 IP address setting

Step 2: Click ―Local Area Connection‖, the local connection status dialog box is
displayed, as shown in figure 1-30.
Step 3: Click "Properties" to bring up the local connection properties dialog box,
as shown in figure 1-31.
System Overview-25
System Overview
Figure 1-30 IP address setting Figure 1-31 IP address setting

Step 4: Double-click "Internet Protocol version 4", as shown below, and enter the
IP address as follows:
Figure 1-32 IP address setting

Step 5: Click ―OK‖ to complete the IP address setting.
1.3.5 Power setting

To avoid computer sleep effects test, you need to cancel the computer sleep
function settings. The steps are as follows:
Step 1: Open the control panel and find the power options.
System Overview-26
System Overview
Figure 1-33 Power setting

Step 2: Balanced (recommended) in the preferred plans, chick ―Change plan
settings‖.

Step 3: Windows7 installation, the default is to set the computer to sleep status,
the settings are as follows.
System Overview-27
System Overview

Step 4: ―Turn off the display‖ and ―Put the computer to sleep‖ are set to "Never",
and then click "Save Changes", as shown below.

Step 5: After setting, ―Save Changes‖ button is ashed, as shown below.
System Overview-28
System Overview
1.3.6 Power on
After installation, install the pure water float switch and washing solution float
switch, so that the floats to keep floating status. Connected to the following
power:
Total power supply and analysis unit power on the right panel of the analyzer,
computer and monitor power supply, the printer power supply.
About 20 minutes after turning on the power supply (Wait for the temperature
and light source stability), instrument into standby mode.
△! Note:
When the instrument is installed for the first time, please perform the water pipe
exhaust 20 times before use to ensure that the air bubbles in the pipe are drained.
1.4 Software introduction&operation

1.4.1 Software interface
The software interface consists of several main parts: the menu bar, the toolbar,
the work area, and the status bar, as shown in figure 1-38.
Tool bar Status bar
Stand by
Workspace
Menu bar
Figure 1-38 Software Interface

1.4.1.1 Menu bar
Menu Bar: Display the function menu of the instrument software operation, click
the menu bar to display the submenu, and click the submenu to display the
software operation interface.
The menu bar is located on the left side of the main interface, and displays the
function menu of the software operation. The menu bar icons and functions are
shown in table 1-5.
Table 1-5 Menu bar and function

No. Figure Function
System Overview-29
System Overview
No. Figure Function
Enter sample information for testing and calibration and

1
QC
2 Edit project parameters, edit calibration, QC parameters
Edit the position information of the reagent to correspond

3
to the reagent position
Test curve, test result query, QC result query, report
4
printing, data maintenance, export
Instrument testing, instrument calibration, absorbance
5 testing, cleaning the cuvette and reading the background
information
Perform data statistics, user management settings, version
6
information query
Sample tray, reagent tray, reaction tray condition
7
monitoring during testing
8 Exit the biochemical instrument software operation
1.4.1.2 Status bar

Located at the top right of the main interface, the current operating user is
displayed in real time, the computer system time is displayed, and the current
working status or test progress is displayed. The display is as shown in figure
1-39:
Figure 1-39 Status Bar

:Displays the name of the current software operator. Users can
add and delete in the Add and Delete Users under the User Management form.
:Display the time of system.
:Display working status.
1.4.1.3 Tool bar
Located at the upper left of the main interface, several commonly used functions
in the software are placed in the toolbar, which is convenient for the user to
quickly perform corresponding operations by mouse click. Details as shown in
figure 1-40.
Start Stop Initialization Connect Alarm Temperature

Figure 1-40 Tool bar
1.4.1.4 Working area
System Overview-30
System Overview
According to the function selected by the user, the interface window of the
corresponding function will appear. For example, if the item entry button is
clicked in the menu bar, the ‗sample entry‘ software interface shown in Figure
1-41 is displayed.
Figure 1-41 Sample testing

1.4.1.5 Version information
Computer software version display in status bar, analyzer
software version: Click , working area will display user manager

interface, click About, then click version, then the software version and analyzer
number will be display.
Figure 1-42 Version information

1.4.1.6 Software functional diagram
System Overview-31
System Overview
Sample Input Input the sample information that needs to be tested
Program Input Calibration&QC Input Calibration and QC of new item
Sample Retest Recalculate samples that need to be retested
Item Parameter Edit the test item parameters
Calibration Parameter Edit the calibration parameters

Item Setting
QC Parameter Edit QC parameters
Specific Item
Edit special item parameters
Parameters’ Setting
The position information of the reagent is edited so
Reagent Reagent Information
as to correspond to reagent tray
Print Maintains print report data
Curves Real-time display of reaction curve of test process
QC Result Query Query the QC result information
Data Processing Export data Export test data and other information
BK-
Data Maintenance Maintain print report data and other’s
200mini
Auto Test Results Correction Query the test results and correct the results
Chemistry
Analyzer Check the information of various parts, and
Instrument check
troubleshoot
Adjustment Adjust the information of mechanical position
Maintenance Absorbency Test Test the absorbance values at each wavelength
Wash && Background Clean the cup and read the background information
Database Maintenance Compress the database, and backup
Statistics Test statistics, workload statistics, cost statistics
Test Result Query Query the test result information

User Setting
User Setting Edit user information
Change User Password Modify user login software password
About View software version information
Sample Status Display the status, location, and type of the sample
Display the type of reagent, the remaining amount,

Monitor Reagent Status
measurable data, etc.
Display the information of the reaction tray, include
Reaction Status
the cuvette number, status, inspection items, etc.
Exit Exit the analyzer software operation
Figure 1-43 Software function diagram
System Overview-32
System Overview
1.4.2 Mouse Usage

 Move
The mouse is replaced by a pointer on the software interface. Place the
mouse on a flat surface and gently move the mouse to overlap the pointer
with the object you want to select or edit on the interface.
 Click
After moving the mouse to overlap the pointer with the object that needs to
be selected or edited, press the left mouse button once and then release it to
complete the click operation.
 Double click
Move the mouse to overlap the pointer with the object you want to select or
edit, press the left mouse button twice quickly, and then release it to
complete the double-click operation.
 Drag
Drag is mainly used to move the drag bar to select a level continuously.
Move the mouse so that the pointer is above the drag bar, hold down the left
mouse button, and move the mouse left and right to move the drag bar left
and right on the ruler until it moves to the desired level.
 Use with the keyboard
Some lists allow you to select multiple objects at once, and you can use the
mouse with the keyboard. When the selection is completed, the selected
content is displayed in brightness.
 The specific operation method is as follows:
If you select multiple non-contiguous objects, press the left mouse button to
select an object, hold down the [Ctrl] key, use the mouse to select other
desired objects, and then release the [Ctrl] key.
If you select multiple consecutive objects, press the left mouse button to
select an object, hold down the [Shift] key, select the last object with the
mouse, and then release the [Shift] key.
1.5 System Parameter

System technical parameter as follow:
Table 1-6 Analyzer technical parameter
Performance Standard
Speed 200T/H
Wavelength 340～800nm
Accuracy ±1nm
Basic
Reaction Temp 37℃±0.1℃
Analysis Items Max 20 items together
Analysis Method End Point, Rate, Fix Time
System Overview-33
System Overview
Sample Position 37
Sample Serum, plasma, urine, CFS, etc.
Sample Sample Volume 2～70μl (0.1μl Step)

System
Sample&Reagent Liquid level sensing, Remaining detection,
Probe Anti-collision function
Probe Washing Inter&external washing
Reagent Position 28
Reagent Volume 20～350μl(1μl Step)

Reagent Bottle
20mL, 50mL
Specification
Reagent
Min Reagent 1mL
System
Sample&Reagent Liquid level sensing, Remaining detection,
Probe Anti-collision function
Probe Washing Inter&external washing
Cooling Function 24 hours cooling function
Cuvette Kind Discrete
Cuvette Qty 48
Reaction Time About 10 mins
Reaction Volume 120～500μl

Light Source 6V/10W Halogen Lamp
Abs Range 0～3.3Abs
Reaction Accuracy 0.0001
System
Liner: K factor, 1-point, 2-point and multipoint.
Calibration Non-Linear: Spline, Polygon, Index, Pgarithm,
Logit-log4p, Logit-log5p.
Real time QC, Westgard multi rule, Cumulative sum
QC
check, Twin Plot(2D)
Auto Washing Auto washing sample probe, cuvettes
Mixing Speed adjustable stirrer with teflon coating.
Port TCP/IP Port
Data Data Processing Real time display reaction curve

System Printer External, multiple reporting mode available
LIS System LIS system support
System Overview-34
System Overview
Net Weight 36Kg
External Sizer 625mm*425mm*460mm(W*D*H)

Analyzer
Power (VA) 300VA
Water Consumption 4L/h
Power Supply AC220V/AC110V,50Hz/60Hz
Installatio
n&Storag Storage: -10℃～40℃, ＜85%RH，
e Storage&Using Working:15℃～30℃，35%RH～80%RH,
Altitude: less than 2000m
System Overview-35
2 Basic Operation
This chapter describes the basic operation methods and daily operation
procedures of the instrument, including the following steps:
 Check before starting
 Turn on analyzer
 Confirm instrument status
 Loading reagent
 Calibration application and testing
 QC application and testing
 Regular sample application and testing
 Emergency sample application and testing
 Test status and test control
 Maintenance
 Shutdown
 Operation after shutdown
Basic operation method
2.1 Operate chart

Table 2-1 Operation chart
Step Details Chart
1. Check before Check water source, power supply, printing paper, low
concentration and high concentration waste liquid 2.2
starting
connection, reagent&sample probe / stirrer
2. Turn on Turn on water purifier and analyzer, log in software 2.3
3. Confirm Confirm system status, alarm status, reagent/calibration
2.4
instrument status status, and maintenance status
4. Reagent
Upload reagents 2.5
loading
Enter the calibration item, prepare the calibration, and
5. Calibration 2.6
start the calibration test.
Enter the QC item, prepare the QC, and start the QC
6. QC 2.7
test.
7. Sample testing Normal sample testing 2.8
8. Emergency Emergency testing 2.9
9. Test status and View reagent status, view calibration, QC, routine and
emergency sample test status, view reagent&sample 2.10
test control
tray status, test pause and emergency stop
10. Maintenance Normal maintenance 2.11
11. Turn off
Turn off water and power 2.12
analyzer
12. Operation Cover the reagent tray, calibrators, controls and
samples into refrigerator, clean the analyzer table, and 2.13
after shutdown
empty the waste container.
2.2 Check before starting

2.2.1 Water Checking
1. Check that the water tank or other external water storage container has
enough deionized water to ensure continuous water supply.
2. Check that the water connection between the water source and the analyzer is
firm and not loose.
3. Check that the catheter is clear and free of distortion and leakage.
2.2.2 Power Checking

1. Check the power supply to verify that the power supply is powered and can
provide the correct voltage.
2. Check the communication line and power cable between the operation unit
and the output unit to confirm that the connection is secure and there is no
looseness.
Basic operation method-2

2.2.3 Printer Paper checking

Check if there is enough paper in the printer. If not enough, please add paper.
2.2.4 Waster Connection

The waste liquid of the instrument is divided into two stages: high-concentration
waste liquid and low-concentration waste liquid. The high-concentration waste
liquid is discharged through the waste liquid tank and then treated specially.
While the low-concentration waste liquid is directly discharged to the sewer.

When checking the waste connection, be sure to wear gloves, wear
overalls to prevent infection, and wear protective glasses if necessary.
1. Check the high-concentration waste liquid tank and check whether the waste
liquid in the barrel is empty. If not empty, empty the waste container.
2. Check the connection of low-concentration waste liquid to ensure that the
waste liquid pipe is not bent, and the drain discharge port of the sewer is not
higher than the waste liquid outlet of the instrument.
2.2.5 Probe Checking

The reagent&sample probe and the stirrer are easily soiled or damaged. Before
starting the machine, please check carefully if there is dirt or bending.
1. Check the reagent&sample probe to confirm that there is no dirt and no
bending.
2. If there is dirt, clean the reagent&sample probe.
3. If there is a bend, replace the reagent&sample probe.
4. Check the stirrer to confirm that there is no dirt on the surface of the stirrer,
and the stirrer is not bent.
5. If there is dirt, clean the stirrer.
6. If there is surface damage such as bending or scratching, replace the stirrer.
2.3 Turn On Analyzer

2.3.1 Turn On the power
After the analyzer is properly connected to the power outlet, turn the power on in
the following order.
1. Turn the power switch. Up is on, and down is off.

Figure 2-1 Analyzer power switch

2. Turn on the cooling switch.
Figure 2-2 Cooling switch

3. Turn on main power switch.
Figure 2-3 Main power switch

4. Turn on printer.
5. Turn on computer.
6. Turn on LIS system computer.
2.3.2 Software
1. Click the conductor of software, when your first time running this software, it
will require software configuration.
Figure 2-4 Online configuration

Figure 2-5 Software configuration Figure 2-6

Configuration Success
Click conductor again, and the login the software, original user name and
password is 1000
Figure 2-7 Login Interface
Note:
If the normal privileged user password is forgotten, you can log in to the system
as an advanced privileged user, delete the username, and then reset it. or contact
Biobase after sale engineer.
3.After the correct login and power-on detection are normal, the main interface of
the operation software is displayed. At this point, the boot process ends. If the
environment is found to be inconsistent during the boot detection process, a
message will pop up. Please take corresponding measures according to the
information displayed on the interface.
After the boot, the instrument acts as follows:
1. The stirring arm is lifted and the cleaning arm is lifted.
2. Stir and swing back and forth to the cleaning position.
3. The reaction disk is reset to zero.
4. Repeat steps 1 and 2 once.
5. The sample arm is lifted and swings left and right.
6. The reagent&sample disc rotates clockwise after returning to zero.
7. Repeat steps 5 and 6 once, after which the instrument enters the standby status.

Note:
After the instrument is powered on and enters the standby status, each
position is not in the zero position. You need to enter the software and click
the initialization command to perform an initialization operation before you
can correspond!
To ensure accurate test results, please display “Standby” in the system status
area and turn it on for approximately twenty minutes before starting the test
operation to ensure stable light source and temperature control.
For the first time, please first exhaust the water pipe 20 times to ensure that
the air bubbles in the pipe are drained.
2.4 Status Confirm

After the startup is completed, confirm the various status of the instrument if
necessary, such as: system status, status of each analysis module, and fault alarm.
2.5 Reagent Preparation

After confirming the instrument status and performing a pre-test check, you need
to prepare the reagents for the test that day. Items that do not have reagents can
be applied, but they cannot participate in the test. The instrument allows loading
of reagents in standby mode. Once the reagent location is set, print out the
reagent list and manually load the required reagents according to the load order.
After loading, manually execute the detection reagent balance and display it on
the [Reagent Information] screen. Otherwise, the reagent count of the [Reagent
Information] screen is displayed as empty.
If the instrument is shipped with an open channel, this open channel can use
Brocade or other brand of reagents, and the rest of the channels are closed
channels, only Brocade reagents can be used. If you need to change the number
of channels, please contact the company's customer service center or the
distributor in your area.
Warning
Please operate carefully, avoid any injury
Biological infection risk

Always wear gloves, work clothes to prevent infection, and wear protective
glasses if necessary.
Do not touch the reagents directly, as this may result in skin damage or
inflammation.
Note:
Place a sufficient amount of reagent before testing to avoid interrupting the

test due to insufficient reagents.

2.5.1 Reagent preparation

The instrument supports manual loading of reagents. Each item can be loaded
with multiple bottles of reagents, and the same item of reagents can be loaded on
the inner and outer rings of the reagent in the same reagent&sample tray. If the
reagent barcode scanner is not selected, the reagent information needs to be
manually input during loading. If the reagent barcode scanner is selected, the
system automatically scans all reagents and obtains reagent information.
Multi-reagent type items must have all reagent types loaded simultaneously in the
inner and outer rings of the reagent. Open reagents can be loaded by manual or
bar code scanning, while blocking reagents can only be loaded by barcode.
Note:
Issue before testing:

It is recommended to carry out the remaining test of the reagent before
starting the batch test. It is recommended that the remaining amount of each
reagent exceeds 20 times of this test quantity before starting the test to ensure
the continuity of the test and the accuracy of the test result.
Reagent usage
The preparation, use and storage of the reagents must be in strict accordance
with the reagent instructions, and do not cause bubbles in the reagents. Since
the reagent contains a surfactant, foaming will occur when the sloshing is
severe. If the reagent&sample probe contacts the foam during the test, it will
be mistakenly judged to have been in contact with the reagent, resulting in
inaccurate absorption of the reagent and affecting the test result.
Never add reagent during testing
If the reagents of different manufacturers or different batches of the same
manufacturer are added to the reagents, the components of the reagents will
be changed, resulting in inaccurate test results.
Loading reagent manually
When loading reagents manually, you need to manually enter the reagent
information and use it as the sole source of information for the reagents to be
loaded. When loading, you can open the reagent tray cover and put the reagents,
and then input the reagent information. You can also input the reagent
information first, then put the reagents. Or enter the reagents and input the
reagent information. If the loaded reagent has a barcode, it is not allowed to
modify the reagent information. If there is no barcode, other information except
the reagent location, bottle size and reagent type are allowed to be modified.
The reagent channels of the BK-200 Auto chemical analyzer are divided into
open channels and closed channels. The reagent entry method for reagent open
channels is to select other information such as reagent items, bottle sizes, and
reagent types from the drop-down list. The reagent entry method for the reagent
closed channel is to scan using a scanner or manually input the barcode.

1. Confirm the system status and perform reagent loading operations according to
different status.
Standby: go directly to the next step.
Test: Wait for all items to be tested, and then load the reagents when the
instrument enters standby mode.
2. Select [Reagent] - [Reagent Information].
3. Select the location where the reagent needs to be loaded.
4. Enter the loaded reagent information in the [Reagent Information Edit] dialog
box, including:
Bar code
Project name
Reagent type
Bottle size
5. Click [Add] to save the input reagent information.
6. Click on the blank location of the other reagents list to load reagents for other
items on the instrument.
7. Open the reagent tray cover.
8. Control the reagent loading list, put each reagent into the corresponding
position on the reagent&sample tray, and then open the reagent bottle cap.
9. Cover the reagent tray cover.
10. Refresh the reagent remaining amount information.
a)Close system reagent loading
Click the REAGENT in software interface, and then display reagent information
menu.as Figure2-8. Scan the reagent barcode with the scanner as reagent tray no.
and click ‗Add‘.
Figure 2-8 Reagent Information(Close System)

If the reagent input sequence is wrong, click ‗Delete‘ button to delete the item
and rescan the code.
b)open system reagent loading

Click REAGENT in the software interface, as figure2-9,Query the reagent items

in the order of the reagent tray, and select the reagent, bottle size and reagent type
and click Modify to enter.
Figure 2-9 Reagent Information (Open system)

c)Reagent remaining
In reagent information interface, click start and enter the remaining test interface.
As Figure 2-10. Determine the range of reagent numbers. After the determination,
the instrument automatically detects the remaining amount of the reagent and the
remaining number of tests. At the end of the test, the detection information is
displayed in the ‗Reagent Information‘ list box.
Figure 2-10 Reagent Remaining Test

During testing the remaining amount of the reagent is detected automatically, and
the remaining reagent amount and the remaining test number are updated.
2.6 Calibration
The calibration test is used to calculate the calibration parameters to participate in
the calculation of the sample results. In general, a calibration test is recommended
when any of the following conditions occur:
Create a new project.

When the reagents, calibrators and controls are still within the validity period, the
QC test generates an alarm.
Replace the reagent lot number or bottle number.
The project exceeded the calibration validity period.
Modified calibration rules including: calibration method, number of repetitions,
calibrator concentration, and calibrators used.
The light source lamp, syringe, reagent&sample probe, etc. were replaced.
If the following parameters are modified, they must be calibrated:
Main wavelength
Secondary wavelength
Blank time
Reaction time
Amount of reagent
Sample size, diluted sample size, and dilution amount corresponding to the
standard amount
Analytical method
Sample type
Reaction direction
Sample blank and result unit
For the method of setting the calibration, refer to "3.3 Calibration Setting" (Scale
Setting - page 6)
2.6.1 Calibration Testing

The calibration test can be applied through the reagent&sample tray according to
the settings of the calibrator.
Calibration for items
When any of the above occurs, please follow the steps below to perform the
calibration.
Before applying for biochemical calibration, make sure the calibration is set
correctly. For details, refer to ‗3.3 Calibration Setup‘ (page 6).
Select [Project Parameters] - [Scale Parameters].
Enter calibration interface

Figure 2-11 Calibration Interface
3.Select items for calibration
2.6.2 Calibrator preparation

Improper use of the calibrator may result in infection. Do not touch the
calibrator directly with your hands. Always wear gloves, work clothes to
prevent infection, and wear protective glasses if necessary. If the calibrator
comes into contact with the skin, please follow the user's working standards
immediately and consult a doctor.
Be careful:
Do not use expired calibrators as this may result in inaccurate measurements.

1. Select [Project Parameters] - [Scale Parameters].
2. Enter the biochemical calibration interface.
3. Set parameters such as the number of repetitions, the calibration mode, the type
of specimen, the number of calibrations, and factors.
4. The list shows all the items that have been applied for calibration, as well as
the calibrator, location, concentration, batch number.
5. In contrast to the printed calibration application list, place the calibrator at the
corresponding position on the reagent&sample tray.
2.6.3 Calibration Start

Note
After the power is turned on, the light source lamp needs to be stable for 20
minutes, and the test can be started when the instrument enters the standby
status.
After applying the calibration test and properly placing the required calibrator,
you can start the calibration test.
1. Click [Set Current Calibration] on the calibration parameter page.
2. Check the calibration status on the page. If [Successful calibration] is displayed,

it means that the calibration test is successful, click [Save]. If [Scale failure] is
displayed, the calibration parameters need to be reset until the calibration is
displayed success.
2.7 QC
QC results are an important tool for monitoring whether the instrument is
performing well. In order to judge whether the instrument test performance is
stable, it is recommended to conduct QC tests every day. Manual QC testing is
possible. The QC product is allowed to add new items under any status. When the
QC item is not tested, the QC information can be modified in the test status, only
the additional items are allowed, and the QC information is not allowed to be
modified.
2.7.1 QC Testing
It is allowed to apply for QC test according to the QC product. You can choose
the QC product, the QC product position and the sample cup type. You must
select at least one item, otherwise you will not be allowed to save the application.
1. Select [Program Input] - [ Calibration&QC Input] - [QC Input]
Figure 2-12 QC Interface
Select [Add] to add the QC test.

In the [QC Lot Number] drop-down list, select the QC lot number to be tested.
Select the QC project to be tested and add it to the [QC Project] list.
In the [QC Number] drop-down list, select the QC position number for the QC
test (ie, the QC product is placed in the reagent&sample tray)
2.7.2 QC Preparation

Be careful:
Do not use expired QC as this may result in inaccurate measurements.

1. Select the QC number in the [QC List] and determine the quantity of the
required product by quantity.
2. Adding QC products to the reagent&sample tray according to the
corresponding QC number in the interface and the order of the QC products.
2.7.3 QC Testing Start

Note
status.
After applying for the QC test and correctly placing the required QC, you can
start the QC test.
After clicking [Start] on the page toolbar, the following prompt box will pop up.
Figure 2-13 QC start interface
After confirming that the number of QC items is correct, click [Start] to start the
test.
2.8 Sample Testing

2.8.1 Normal sample testing
When applying for a sample test, you can choose to apply for a single sample or
apply for a sample in batches.

Add test items

Click [Item Entry] on the toolbar to enter the [Sample Entry] form, as shown
below:
Figure 2-14 Item Entry
Single sample entry

1. Click [Item Entry] on the toolbar, enter the [Sample Entry] form, and select
[Add] on the right side.
2. In the [Test Items] column on the left, select the items to be tested, click "" to
select the "Selected Test Items" column, and then select/fill in the patient
information "Name", "Gender", "Age" "Wait, select the "Send Inspection
Department", "Sample Type", "Sent to the Doctor" and other information. After
the login is completed, click "" to complete the operation. Enter the sample
number in [Number]. The number can consist of numbers or letters and numbers,
is not case sensitive, and cannot exceed 10 digits in length.
3. Enter the sample position. The sample bit number generally starts from 1, and
the number of the day starts from 1 by default. A duplicate sample number cannot
be set during the last Auto release of the sample until the next release of the
sample.
4. In the following order, fill in the patient's letter "name", "gender", "age", etc.,
and edit the information of "sent inspection department", "send inspection doctor"
and so on.
5. Select the type of sample in the [Sample Type] drop-down list.
Options include: serum, plasma, urine, cerebrospinal fluid and others.
6. Select the sample size to be drawn in the [Sample Size] drop-down list in the
sample attribute area. The options include standard, incremental and decrement.
7. Set whether a sample blank test is required.
8. Select the type of sample cup to use in the [Sample Cup] drop-down list.
Options include micro cups and standard cups.
9. Choose whether to [dilute].
10. The number of times the sample needs to be repeated in [Repeat Times].
The input range is from 1 to 90, and the default is one.
11. If an item in the sample has an application request that is different from the
other items, enter the following information:
[Sample size]: Select the sample size required for the project test. This sample
size type is consistent with the sample size type defined when setting up the
project. If the incremental sample size and the reduced sample size are defined,
the increment or decrement can be selected here. Otherwise only the standard
amount is allowed to be selected.
[Number of repetitions]: Enter the number of repeated tests for the item.
[Sample blank]: Set whether to perform sample blank test separately for the
project.
Click [Save].
Batch Sample Entry

When batch sample entry, 37 samples maximum one time. Except for the sample
position, sample number and barcode, the sample information, project
information, and patient information of the batch application sample are identical
to the initial sample. The sample bit number input starts from 1 to 37, and the
sample bit number changes from 37 to 1 and then increments from 1. Select the
item to be tested and save it to complete the operation.
1. Click [Item Entry], enter the [Sample Entry] interface, and select [Batch Entry]
at the bottom right of the interface.
2. Select the bit number of the first sample in [Sample Bit Number].
3. Enter the number of samples for the batch test in [Quantity].
5. Select the project to be tested in the project list, or select the combined project
to be tested in the combined project list.
6. Set the following parameters as needed:
Sample size type
Sample blank
Cup type
Repeat times
7. Click [OK]
Entry Information of Sample

Patient information can be entered at any time. After the sample test is finished,
the patient information can be viewed and modified through the [Data Processing]
and [Item Entry] interfaces.
Method 1: Change in the [Data Processing] interface

Figure 2-15 Data Management Interface
1. Click [Data Processing] - [Report Print].

2. After entering the interface, select the number you want to modify in the
sample number to modify the related information.
Method 2: Modify the [item directory entry] interface
Figure 2-16 Item Entry Interface
1. Click [Item Entry] - [Sample Entry].

2. After entering the interface, select the sample to be modified in the input
sample list.
3. Click [Modify] to modify the relevant sample information.
2.8.2 Sample Preparation

Be careful:
Do not use expired sample as this may result in inaccurate measurements.
Note:
Before loading the sample, make sure there are no bubbles in the sample tube
to avoid inaccurate test results.
1. Click [Data Processing] - [Report Print].
2. After entering the interface, the sample corresponding to the sample is placed
in the reagent&sample tray according to the sample number and the patient
information.
2.8.3 Start Testing

Note
status.
After the sample is completed, the temperature is stable. After all other test
conditions are set, click the start button in the toolbar. The pop-up dialog
box is shown in Figure 2-17. Click ‗Start‘ to enter the sample test process.
a) b)
Figure 2-17 Sample Testing Start
2.9 Emergency Sample Testing(STAT)

Emergency sample can be prioritized through an emergency application.
2.9.1 Emergency Sample Entry

Single emergency sample entry

[Add] on the right side.
2. In the [Test Items] column on the left, select the items to be tested, click to
select the ―Selected Test Items" column, and then fill in the patient's letter ‗name‘,
‗gender‘, ‗age‘ "Wait, edit the information of the "submission department",
"sample type‘, "send the doctor", etc. After the login is completed, click [Save] to
complete the operation. Enter the sample number in [No.].
The number can consist of numbers or letters and numbers, is not case sensitive,
and cannot exceed 10 digits in length.
3. Enter the sample position, the emergency sample cannot be set with the sample
number that is duplicated with the sample being tested.
4. In the following order, fill in the patient's letter "name", "gender", "age", etc.,
and edit the information of "sent inspection department", "send inspection doctor"
and so on.
Options include: serum, plasma, urine, cerebrospinal fluid and others.
6. Select the sample size to be drawn in the [Sample Size] drop-down list in the
sample attribute area. The options include standard, incremental and decrement.
7. Set whether a sample blank test is required.
8. Select the type of sample cup to use in the [Sample Cup] drop-down list.
Options include micro cups and standard cups.
9. Choose whether to [dilute].
10. Select the [Emergency] check box.
11. The number of times the sample needs to be repeated in [Repeat Times].
The input range is from 1 to 90, and the default is one.
[Sample size]: Select the sample size required for the project test. This sample
size type is consistent with the sample size type defined when setting up the
project. If the incremental sample size and the reduced sample size are defined,
the increment or decrement can be selected here. otherwise only the standard
amount is allowed to be selected.
[Number of repetitions]: Enter the number of repeated tests for the item.
[Sample blank]: Set whether to perform sample blank test separately for the
project.
Click [Save].
Batch emergency sample entry

When entering a batch of emergency samples, you can apply for up to 37 samples
at a time. Except for the sample position, sample number and barcode, the sample
information, project information, and patient information of the batch application
sample are identical to the initial sample. The sample bit number input starts from
1 to 37, and the sample bit number changes from 37 to 1 and then increments
from 1. Select the item to be tested and save it to complete the operation.
[Batch Entry] at the bottom right of the interface.
2. Enter the number of the first emergency sample in [Sample No.].
3. Select the bit number of the first emergency sample in [Sample No.].
4. Enter the number of emergency samples for batch testing in [Quantity].
6. Select the project to be tested in the project list.
7. Select the combined project to be tested in the list of combined projects.
8. Set the following parameters as needed:
Sample size
Sample blank
Sample cup
Repeat times
9. Select the [Emergency] check box.
[sample size]
【repeat times】
[sample blank]
11. Click [OK].
2.9.2 Emergency Sample Preparation

Be careful:
Do not use expired sample as this may result in inaccurate measurements.
Note:
Before loading the sample, make sure there are no bubbles in the sample tube
to avoid inaccurate test results.
Place the sample:

Place the sample in the designated position on the reagent&sample tray and
ensure that the sample cup is inserted into the reagent tube until the bottom of the
sample cup is in full contact with the annular groove of the tube holder

2.9.3 Testing Start

Note
status.
After the sample is completed, the temperature is stable. After all other test
conditions are set, click the start button in the toolbar. The pop-up dialog
box is shown in Figure 2-18. Click ‗Start‘ to enter the sample test process.
a) b)
Figure 2-18 Sample Testing
2.10 Testing condition and control

During the test, the sample test status is displayed in the status bar, as shown in
Figure 2-19 a).
During the sample test, click on the menu bar to monitor the status of the
instrument sample tray, reagent tray, and reaction tray in real time, as shown in
Figure 2-19 b).
Sample Condition

b) Status Monitor
Figure 2-19 Sample Testing
Sample tray monitoring: Click “Sample tray status” under the “Monitor” form
to display the status of the sample tray on the left side of the form, as shown in
Figure 2-20, where the sample tray uses different colors to distinguish the status
of the sample. After you have applied for a sample test and placed the required
samples correctly, you can start the test. To view the sample results, refer to "8.12
Sample Results Viewing and Processing" (page 8-40).
Reagent Disk Monitoring: Click“Reagent Disk Status”under the“Monitoring”
form to display the reagent disk detection status on the left side of the form, as
shown in Figure 2-21:
Figure 2-20 Sample Tray Figure 2-21 Reagent Tray

The reagent tray indicates the reagent placement number according to the serial
number. When the reagent is detected by the instrument, the software
automatically calculates the remaining amount of the reagent and displays it in
the reagent information. In the reagent tray: white indicates idle, yellow indicates
less reagent, green indicates sufficient reagent, and red indicates no reagent.
Reaction tray monitoring: The reaction tray displays the status of the reaction in
real time during the sample detection process. Click on “Reaction Disk Status”
under the “Monitor” form, as shown in Figure 2-22, where different colors
indicate that the cuvette is in different working status.
Figure 2-22 Reagent Tray Monitor

(a) Test suspension, continue
While the sample test is in progress, you can click the button or in the
toolbar to control the test process. Click to stop the test status, click to
continue the test.
(b) Sample addition
During the test, if there is a sample that needs to be added, you can directly click
on ‗Sample Entry‘ and add samples to be tested as needed.
2.11 Daily Maintenance

After the test is finished every day, the instrument should be maintained
according to the needs of routine maintenance.
Daily maintenance items include:
Check reagent&sample probe / stirrer
Check syringe
Check pure water connection
Check waste connection
For details, refer to ‗13.3 Daily Maintenance‘ (page 6).
2.12 Turn Off

1. Confirm that the system is in the Standby status.

2. Select [Exit] on the left side of the main interface, and click Shutdown on the
Windows operating system interface to close.
3. Turn off the power in the following order:
Printer power supply
Operation unit display power supply
Analysis main power supply
Computer monitor power supply with data management software (optional) or
LIS (optional)
Water supply module (optional) power supply
After the main power of the analysis department is turned off, the refrigeration
system continues to work. If the instrument will be out of service for a long time
or not used for more than 7 days, turn off the mains power
2.13 Operation after turn off analyzer

1. Open the reagent&sample tray cover and take out the calibrator, QC and
sample.
2. Check if the surface of the analysis module is stained. If so, wipe the stain with
a clean soft cloth.
3. Check the high concentration waste liquid tank. If there is waste liquid, empty
the waste container.

3 System Setting
This chapter describes the basic setup methods for the instrument, including:
 System settings
 Project parameter setting
 Calibration settings
 QC setting
3.1System Setting
3.1.1 Brief introduction
This section mainly introduce some of the setup options for system settings.
3.1.2Sample information and testing information setting

The following settings can be made through the sample entry interface.
Default sample type
The sample types supported by the system include: serum, plasma, urine, cerebrospinal fluid and
others. The default is serum. After resetting the default sample type, the new default sample type
will be selected by default when you apply for a sample test on the [Sample Entry] screen.
Default sample cup type
The sample cup types supported by the system include standard cups and micro cups. The default
is standard cups. After resetting the default sample cup type, the new default sample cup type will
be selected by default when applying the sample test on the [Sample Entry] screen.
Reagent&sample probe fortified cleaning
After many tests are continuously tested, the reagent&sample probe may be blocked. In order to
reduce the probe plugging, the system automatically performs intensive cleaning of the
reagent&sample probe after each batch of sample testing is completed.
Alarm message for each bottle of reagents
A project can load multiple bottles of reagents. If one of the reagents is used up, the system will
give an alarm when one bottle of reagents is used up.
Result display settings
The result display settings are used to set the result flag for test results below and above the
reference range. Set in [Data Processing] - [Data Maintenance] - [Extra Display], you can select
↑↓ or HL to display whether it is exceeded.
View software version information
Through the [User Management] interface, [About], you can view the version information of the
operating software, control software, and other control software. For more information, please
refer to 11.2 Version Information (page 3).
3.1.3 LIS settings

Through the [Data Export] interface, you can set the parameters connected to the LIS host and the
test result transmission method. For more information, please refer to "12.2 LIS Communication
Parameter Settings" (page 2).
3.1.4 User Settings

Through the [User Management] interface, you can set user passwords and permissions to define
and delete users. For more information, please refer to "11.1.4 User and Password Settings" (page
2).
3.2 Item Setting

3.2.1 Introduction
The system supports both closed reagent and open reagent projects, and each instrument closed
system allows up to 28 open projects. The same set of parameters in the same project in different
instruments will be effective for the whole system by adding, modifying, and deleting the project
parameters. For the closed reagent project, only the reagents provided by the company can be used.
Except for the print name, result unit, number of results, judgment parameters and correction
2
coefficient, other project parameters can only be viewed, and modification and deletion are not
allowed. [Project parameters] interface as shown below:
Figure 3-1 Item Setting Interface
Figure 3-2 Sample information Interface
The following sections detail the settings for user-defined projects and the settings for various
project parameters.
3.2.2 Parameter Setting

This section describes how to set the basic parameters of the project.
Item name
The project name is the unique identifier of the project and is not allowed to be repeated. You can
enter up to 10 characters and the case is case sensitive.
3
Item Number
The item number is a unique number for the item and is not allowed to be repeated. The numbers
must all consist of numbers.
Chinese Name
Refers to the full name of the project name. You can enter any character and you can enter up to
36 characters. The input is not case sensitive. The full name of the project can be empty or
repeated.
Minimum absorbance, maximum absorbance, normal high value, normal low value, lowest test
value, highest test value
The specific information is filled in according to the requirements of the reagent manual.
Details
Detailed information including gender, sample type, upper and lower limits, normal high and low
values are determined by the reagent instructions.
Sample type
The sample type refers to the type of sample to which the project applies, including: serum,
plasma, urine, cerebrospinal fluid, and others. The [Sample Type] drop-down box contains the
options for the sample types supported by the project. The default sample type is displayed by
default. The system supports setting parameters for multiple sample types for the same project,
including basic parameters and result judgment parameters. The sample type of the closed project
is imported through the parameter table, and the sample type of the open project can be
customized by the user. When setting project parameters for various sample types of open projects,
you must first set parameters for the serum samples and then set the parameters for the other
sample types. The parameters of the serum sample type are used by default when calibrating.
Analysis Method
The analysis method refers to the analysis method used to calculate the test results when the
project is tested. Options include: one-point endpoint method, two-point endpoint method,
fixed-time method, and rate method.
Table 3-1 Analysis Method
Quantitative analysis of the substance based on the absorption spectrum
End point
characteristics of the reaction product at the equilibrium of the reaction
method
and its magnitude of light absorption.
It means that the reaction rate is proportional to the primary concentration
of the substrate during a certain reaction time. As the substrate is
continuously consumed, the overall reaction rate is continuously reduced,
Fix Time
and the increase or decrease in absorbance is becoming smaller and
smaller. This type of reaction takes a long time to reach equilibrium and it
takes a period of delay to enter the stable reaction period.
It is used to continuously measure the multi-point data of the concentration
of a certain reaction product or substrate in the enzymatic reaction with
Rate time, determine the initial velocity of the enzyme reaction, and indirectly
calculate the enzyme activity concentration. Mainly used for the
determination of enzyme activity.
Main Wavelength
The dominant wavelength should be selected based on the characteristics of the light absorption of
the particular reaction product and used to detect the light absorption intensity of the reactants.
Options include: 340 nm, 405 nm, 450 nm, 510 nm, 546 nm, 578 nm, 630 nm, and 700 nm.
4
Sub Wavelength
The secondary wavelength is used to correct the absorbance value measured at the dominant
wavelength and to reduce the effects of noise such as flickering, drifting, and scratching of the
cuvette. The secondary wavelength cannot be the same as the dominant wavelength. Options
include: vacant, 340 nm, 405 nm, 450 nm, 510 nm, 546 nm, 578 nm, 630 nm, and 700 nm.
Decimal number
The number of decimal places is the number of digits retained after the decimal point in the result
value. 0 to 3 decimal places available. Options include: 0, 0.1, 0.01, and 0.001.
Sample size, standard amount, sample size released, volume of sputum release, increment,
reduction
The sample size, the standard amount, refers to the amount of sample that needs to be added in a
standard test. The range is from 2 μl to 70 μl, in increments of 1 μl, and the default is 3 μl.
You can enter up to one decimal place.
The diluted sample size refers to the original amount of the sample involved in the dilution.
The amount of diluent refers to the amount of diluent involved in the dilution. The range is from 0
μl to 200μl, and the default is 0μl. You can enter up to one decimal place.
Note:
If the diluted sample size and dilution amount are set, make sure that the sum of the two is within
100μl ~ 280μl. otherwise it cannot be saved.
The diluted sample size input method for standard, incremental, and decrement tests is the same.
Decrease refers to the amount of sample that needs to be added during the decrement test. The
range is from 0 μl to 70 μl, in increments of 0.1 μl, and the default is 0 μl. You can enter up
to one decimal place.
Increment is the amount of sample that needs to be added in an incremental test. The range is from
0 μl to 70 μl, in increments of 0.1 μl, and the default is 0 μl. You can enter up to one
decimal place.
Note:
If the diluted sample size and dilution amount are set, the diluted sample will be used for normal,
incremental or decrement testing. if the diluted sample size and dilution amount are not set, the
normal, incremental or decremented sample size will be used accordingly. Test.
Sample blank
The sample blank is similar to the normal sample test except that the reagent is changed to the
same amount of normal saline and then tested in the same procedure as the normal sample. The
sample blank test was used to rule out the effects of non-colorimetric reactions such as sample
interference (hemolysis, jaundice, and lipemia) on absorbance. Sample blanks are only valid for
the single-agent endpoint method. Select the check box before [Sample Blank] to indicate that the
project must be sample blank test before the test, and the project is automatically selected in the
‗Sample Blank‘ column of the [Project Options] and [Retest] screens, and cannot be modified.
R1 amount, R2 amount
Input range of R1: 20μl ~ 350μl for conventional reagents, 240μl by default, in increments of 1μl.
The input range of R2: 0μl ~ 255μl, the default is 60μl, in 1μl increments.
R1 and R2 can be input at the same time, regardless of the order.
5
3.2.3Judging parameter settings
This section describes how to set the judgment parameters of the project.
Linear limit
The linear limit is only valid for the rate method. For rate method items, the absorbance during the
reaction time should be linear with the time (response curve). If the substrate is depleted, or the
photometer fluctuates or the agitation is uneven, it will lead to erroneous test results. Therefore,
the system calculates the linearity of the measurement time, and compares it with the linear limit
to detect whether the linear range of absorbance participating in the calculation of the reactivity is
linear.
If the linear range of reaction data does not satisfy the linear judgment, the system will add the
mark "UNLINE" to the result report.
The linear limit ranges from 0 to 1 and is accurate to two decimal places. The default is empty,
indicating that the linear limit is not determined.
Substrate depletion limit
The substrate depletion limit is only valid for the kinetic method and the fixed time method and is
calculated by the following equation:
Substrate depletion limit = input substrate depletion limit + K (L1-Lb)
among them,
L1: sample test, the main wavelength absorbance of the first metering point after the sample is
added
Lb: reagent blank or 0 concentration calibrator test, adding the main wavelength absorbance of the
first metering point after sample agitation
K: liquid correction factor
When L1-Lb ≤ 0, or when no reagent blank test or 0 concentration calibrator test is performed, no
correction will be made. The calibration test does not correct for substrate depletion.
For the positive effect, when the main wavelength absorbance of the photometric point is greater
than the corrected substrate depletion limit, the substrate is depleted at this point. for the negative
effect, the main wavelength absorbance of the photometric point is less than the corrected
substrate consumption. When the time limit is reached, the substrate is exhausted at this point.
Front belt inspection
There are two methods for anterior examination: rate checking and antigen addition.
Rate check method:
If the rate check method is selected, six auxiliary judgment values need to be set, namely: Q1, Q2,
PC, and ABS. Units should be consistent with reaction time and blank time.
The four-value input range is:
Single reagent item: 5≤q1<q2≤33, 5 is the first metering point after the sample is stirred.
Double reagent item: 17≤q1<q2≤33, 17 is the first metering point after adding R2 to stir.
PC: Any value between -99999999~99999999, the precision is 4 digits after the decimal point.
ABS: Any integer between -99999999 and 99999999.
Antigen addition method:
If the antigen addition method is selected, it is necessary to set three judgment values of Q1, Q2
and PC, and the other three judgment values are not allowed to be input.
6
The input ranges of the three judgment values are:
Q1: 39 ≥ Q1 ≥ the end of the reaction time.
Q2: 69 ≥ Q2 ≥ 41. PC: Any value between -99999999 and 99999999, the precision is 4 digits after
the decimal point.
3.2.4 Correction factor setting

The correction factor includes the slope and the intercept, which is the compensation coefficient
used to compensate the test result of the project when an item has a small overall offset in the QC
test.
After the test is over, the system automatically corrects the test results with the correction factor
according to the following equation:
y=kx+b
Where x is the result before correction, y is the corrected result, k is the correction slope, and b is
the correction intercept.
The system allows you to set the correction factor for each analyzer configured project, typically
defaulting to K=1, b=0.
3.3 Calibration Setting

3.3.1 Introduction
The calibration settings include the following steps:
Add/edit calibrators
Set calibrator concentration
Set calibration rules
Set calibration detection information
New, modified, and deleted calibrators are allowed only when the system is in a non-test status.
Figure 3-3 Cal Parameter Interface
3.3.2 Edit calibrators, set calibrator concentration, set calibration mode

It is only allowed to modify the calibrator information, set the calibrator concentration, and set the
calibration mode when the system is in the non-test status. After defining the calibrator, you need
to set the calibration mode of the project. After the calibration mode is set, the concentration of the
corresponding item of the calibrator must be set. The concentration of the same calibrator
7
corresponding to the same item is the same on each instrument. The project calibration test is only
allowed if the calibrator position and concentration are set.
1. Select [Project Parameters] - [Scale Parameters].
2. Select the calibrator you want to modify in the item list, and click [Scale Setting] - [Modify].
3. The following information of the calibrator can be modified in the middle of the interface:
Project name
Calibration mode
Specimen type
4. The calibration mode includes:
Options include:
A little linear
Two-point linear
Multi-point linearity
Logistic-Log 4P
Logistic-Log 5P
Factor
Polyline (but origin)
Spline
5. If the factor method is selected, enter the K factor in [Factor].
This field is only active when a single-point linear calibration rule is selected. After inputting the
K factor, the calibration result is calculated as Y=K*X. Y represents the calibration result, K
represents the factor, and X represents the degree of reactivity. As long as the K factor is entered,
it can be used to calculate sample results without performing a calibration test.
6. Write the number of repetitions of the calibration test in [Repeat Times], which is generally 1
by default.
7. After selecting the calibration mode, determine the number of calibrations.
A project can select up to 10 calibrators (including water), and the number of calibrators should
correspond to the selected calibration rules, as shown in the following table:
Figure3-2 relationship between calibration rules and the number of calibration products
Calibration Calibration
Example
mode Quantity
Factor — CK-MB
A linear 1 calibration GLU，TP，ALB

calibration,
Two linear TBIL，DBIL
Water blank
Multipoint
3～6 calibration —
linear
Logit-Log 4P 4～6 calibration ApoA1，ApoB
Logit-Log 5P 5～6 calibration C3，IgA，IgG，IgM
spline 5～6 calibration C4
broken line 5～6 calibration AFP，CRP
8、After determining the number of calibration, set the corresponding absorbance, concentration
and cup size
9、Click [save] to save the Settings of calibration.
8
3.3.3 Delete calibration
In addition to the system's own WATER, delete calibration information is allowed.
After the calibration product is deleted, All Settings are deleted. Calibration products
can no longer participate in the calibration application, but the historical results of
calibration products can still be searched according to the project. Only if the
calibration product is not tested, it can be deleted.
1、Select [project parameters] - [calibration parameters]
2、Select the calibration item you want to delete in the calibration item list area
3、Click "scale delete"
4、Click "save" to complete the delete operation
3.4 QC setting
3.4.1 Introduction
QC Settings include the following steps:
Add/edit QC products
Select applicable items
Set the concentration parameters of QC products
Set QC rules
3.4.2 Add/edit QC products
When setting, the name of QC product must be selected. The name and batch number
combination of QC products cannot repeat. If the batch number is not set for the QC
product, it is not allowed to define the QC product with the same name. Only when
the system is in the standby status, only allow to add or edit QC.
Figure 3-4 [QC parameters] interface

1、Select [project parameters] - [QC parameters].
9
2、Click [add].
Figure 3-5 [project add] interface

3、Enter the corresponding batch number in [batch number].
4、Select the QC project to be tested in the optional project list and click the left and
right arrow to import it into [selected project].
5、Click [save] to save the Settings of QC products.
6、To set up more QC products, click [add] and repeat steps 2 to 6
7、If you want to cancel an item, then re-select it and click [cancel].
3.4.3 Item Selection

After setting up the QC products, it is necessary to select the items applicable to the QC products.
When selecting a project, make sure the system is in standby mode.
Figure 3-6 [QC input] interface

1、Select "project input" - "calibration QC input".
2、Click [add].
3、Select the corresponding batch number in the "QC batch number" drop-down list.
10
4、Select the item applicable to QC products in the middle list, and click the left and right arrow
buttons to import it into [QC items].
5、Confirm the [QC digit] of the QC item (i.e. the position of the reagent&sample tray).
6、Click [save] to save the Settings of QC products.
7、To set up more QC products, click [add] and repeat steps 2 to 6.
8、If you want to cancel an item, then re-select it and click [cancel].
3.4.4 Set the concentration parameters of QC products

After defining QC products and selecting applicable items, the target value and standard deviation
of QC products corresponding to the items must be set. Only when the position and concentration
of QC products are set, can the project apply for QC test. If QC is carried out on the calculation
items,
The target value and standard deviation must be set, otherwise the QC results cannot be calculated.
If no target values are set for the sub-items participating in the calculation
And standard deviation, cannot carry on the QC judgment and view the QC chart.
1、 Select [project parameters] - [QC parameters].
Figure 3-7 [project parameters] interface

2、Select the corresponding batch number in the list of QC batch number.
3、Select the corresponding item in [project name] to modify the target value and standard
deviation (the specific value is determined by the QC manual).
4、Click [save] to save the concentration parameter Settings.
3.4.5 Set QC Rules

After setting the QC products and the corresponding project concentration, the QC rules of the
project shall be set. If the QC rules are not setted, the project can still apply for QC test. But the
system will not provide real-time alarm function. If necessary, the QC rules can be modified when
the system is in a non-test status. Each instrument will judge the QC data on the instrument
according to the QC rules.
In the "data processing", open the "QC result query" interface, and select the corresponding
QC rules in the drop-down list of QC rules, as shown in the figure below:
11
Figure 3-8 QC rules
3.4.6 Delete the QC

When the system is in non-test status, allow to delete the QC. After QC is deleted, QC
information, concentration parameters and
All the QC results were deleted and the positions were released.
QC products that have been applied for QC testing are not allowed to be deleted.
1、Select [project parameters] - [QC parameters].
2、Select the corresponding batch number of QC products to be deleted from the list of QC batch
Numbers.
3、Click [delete].
12
4 Calculation Method
This chapter briefly introduces the measuring principle of the instrument, including:
 Analysis method
 Verification type and parameter calculation method
13
Calculation method
4.1 Introduction
The instrument is a fully Auto, discrete, random clinical chemical analyzer, the whole process by
the computer control. With the help of various calculation methods and measurement principles,
can quickly complete the test.
The data analysis and calculation process of the system is shown in the following figure:
AD
Absorbance
Reactivity
Calibration parameters
Test results QC results
QC judgment
Figure 4-1 Data analysis and calculation process
First, the system tested the intensity of the light through photoelectric conversion, linear
amplification and AD conversion, and then calculated the absorbance of the reaction solution
and the change rate of absorbance according to the intensity of light, i.e., the reactivity, and
then calculated the calibration parameters according to the reactivity. Finally, carry out QC
testing, calculate the QC results, judge whether the system is stable, and then calculate the
sample test results according to the calibration parameters.
4.2 Analysis method

Chemistry analyzer is based on the material selective absorption of light, analysis
methods that based on Lambert - Beer law.
Its detection principle is: The 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   bc
T   It 
Among them:
A - Absorbance is absorbed by solution.
T - The Ratio of transmitted light intensity and incident light intensity, transmittance.
Calculation Method -14
Calculation method
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. 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.
The system uses the following three analysis methods:
 End point method
 Fixed time method
 Rate method
In the introduction of each analytical method, L and M represent the reaction time. If it is a
dual-wavelength test, the absorbance A is the difference of the absorbance between the main
wavelength and auxiliary wavelength. If it is a single wavelength test, A is the main wavelength
absorbance.
Attention:
Please set reagent parameter refer to the insert of the reagents.

1: When the analyzer measuring, the reaction solution volume
range should be 120～500μl.
2: For reading points not used, be sure to enter "0." in the
software.
4.3 End point method

The end point method means that after a period of reaction, the reaction reaches equilibrium.
Since the equilibrium constant of the reaction is large, it can be considered that all the substrates
(test substances) are converted into products, the absorbance of the reaction liquid is no longer
increased (or decreased), and the absorbance is The degree of increase (or decrease) is
proportional to the concentration of the analyte. This type of method is often referred to as the
"end point" method, and more specifically, the "balance" method, which is the most ideal type of

Calculation method
analysis. It is not sensitive to small changes in reaction conditions (such as enzyme amount, pH,
temperature, etc.), as long as the change does not affect the equilibrium of the reaction within a
certain period of time.
4.3.2 One point end point method

After adding samples and reagents, absorbance was measured at a metering point
specified, the method to calculate the concentration of the sample that is end point
method. Response curve shown in figure 4-2:
Absorbance
measure range
B
R1 S R2
C
Time
Figure 4-2 One 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
CX  {K  ( AX  A1 )} IFA  IFB
Cx 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.
4.3.3 Two point end point method

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
absorbance between these two metering points are used to calculate sample
concentration, called two endpoint, reaction curve shows below:

Calculation method
Absorbance
R2
Cup blank
B1
S
R1
B1
Time
Figure 4-3 Two endpoint reaction curve
(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
k b
S   Ri
i 1
a: Determination of the number of AL reagent.

b: Measuring of the number of reagent AM.
(c) Concentration Calculation
CX  K   AX  B   C1 IFA  IFB
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.

Calculation method
4.4 Fixed time method

The fixed-time method, also known as the first-order kinetic method, means that the reaction
rate is proportional to the primary concentration of the substrate during a certain reaction time,
that is, v=k[S]. As the substrate is continuously consumed, the overall reaction rate is continuously
reduced, and the increase (or decrease) of the absorbance is becoming smaller and smaller. The
time for such a reaction to reach equilibrium is long, and theoretically it can be at any time.
Monitoring, but due to the complex serum composition, the reaction is more complicated when the
reaction is started, and the reaction is more complicated. It takes a period of delay to enter the
stable reaction period.
For any first-order reaction, the substrate concentration [S] at a given time t after the start of
the reaction is:
SS0ekt
Among them:
 S0 is the initial substrate concentration.
 e is the bottom of the natural logarithm.
 k is the speed constant.
The relationship between the change amount of substrate concentration Δ[S] and [S0] in the
fixed time interval from t1 to t2
In the fixed time interval from t1 to t2, the relationship between the change amount Δ[S] of the
substrate concentration and [S0] is:
That is, in a fixed time interval TL~TM, the amount of change in substrate concentration is
proportional to the initial concentration of the substrate. This is the generality of a reaction. The
increase (or decrease) of the absorbance during the period and the concentration of the analyte The
proportional time method is also called initial rate method, first-order dynamic method, two-point
dynamic method, etc. According to the input form of the metering point, the fixed time method
can be divided into single interval fixed time method and double interval fixed method. Time
method. The double interval fixed time method can deduct the sample blank in real time, that is,
the absorbance change between two points in a certain period of time is used as the sample blank
deduction.
4.4.2 Calculation
Reaction curve shows as figure 4-4:

Calculation method
Absorbance
Reaction boundary level

AM
AM-1
R2
Cup blank
B1
S
R1
t
B1
Time
Figure 4-4 Fixed time reaction curve
(a) Metering points: [L]-[M]-[0]-[0](1＜L＜M≤49)

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:
 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   C1  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, C1 is 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

Calculation method
4.5 Rate method

The rate method, also known as the zero-order kinetic method, means that the reaction rate is
proportional to the zeroth power of the substrate concentration, that is, independent of the
substrate concentration. Therefore, the reactant can uniformly form a certain product throughout
the reaction. The absorbance of the solution to be measured is uniformly reduced or increased at a
certain wavelength, and the speed of decrease or increase is proportional to the activity or
concentration of the analyte (catalyst). The kinetic method is also called continuous monitoring.
For the determination of enzyme activity. In fact, because the substrate concentration is not likely
to be large enough, as the reaction proceeds, the substrate is consumed to a certain extent, the
reaction is no longer zero-order, therefore, the zero-order kinetics method is In the specific time
period, similarly, due to the complex serum composition, the reaction is more complicated when
the reaction is started, and the reaction is more complicated. It takes a period of delay to enter the
stable reaction period, and each reagent manufacturer has strict regulations for these two periods.
A method for determining the concentration or activity value based on the rate of change of
absorbance per minute between two metering points, called the rate method.
4.5.2 Calculation
Reaction curve show as 4-5:
Absorbance
R1 S
R2
Cup blank
B1
AL AM
Reaction boundary level
B1
Time
Figure 4-5 Rate method reaction curve
(a) Metering point: [L]-[M]-[0]-[0](1＜L＜M≤49, L+2＜M)

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～R2 is additional reagent position, A( M  L) is the average

metering point between L and M change in absorbance per minute, Cx is sample
Calculation method
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.
4.6 Calibration method

There are two main types of calibration methods, linear calibration and nonlinear calibration.
Linear calibration includes single-point linear calibration ( factor method), two-point linear
calibration, and multi-point (greater than 2 points) linear calibration, which is mainly used for
comparison. The items determined by the color method. The non-linear calibration mainly
includes Logit-log4P, Logit-log5P, polyline method, and spline function method, which are
mainly applicable to the items determined by turbidimetry.
4.6.2 linear method
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:
Absorbance
Ax
B STD(1)
C1 Cx Concentration
Figure 4-6 One point linear calibration curve (K factor method)
(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 parameter
B(S1ABS): The absorbance of the calibration solution 1 or the rate of change in
absorbance per minute.
Calculation method
K: Input value
C1: The concentration of the calibration solution 1 is the input value.
(d) Calculation of Concentration
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.
Two point linear method

Determination of the calibration liquid 1 and calibration liquid 2, formation of a
linear working curve, as shown in figure 4-7:
Absorbance
A2 STD(2)
Ax Sample
B STD(1)
C1 Cx C2 Concentration
Figure 4-7 Two point linear calibration curve

Calibration type: [2 point linear]
Calibration point: [2] (the number of calibration fluid)
Range point: [2 ~ 6]
(b) Calculation of working curve parameter
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.
Calculation method
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

(d) Applicable analysis method
Multi-point 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:
Absorbance
A10
A9
A8
A7
A6
A5
A4
A3
Ax
A2
B
C1 C2 Cx C3 C4 C5 C6 C7 C8 C9 C10 Concentration
Figure 4-8 Multipoint linear calibration curve(linear)

Calibration type: [multi-linear]
Calibration points: [3-6] (Number of calibration solution)
Range point: [3-6]
(b) Calculation working curve parameter

Calculation method
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
S1ABS ( B)  A 
Y
Y
K
X
  
n
X   Cri  Cr  Ai  A
i 1
 
n
Y   Cri  Cr
2
i 1
 n 
A    Ai  / n
 i 1 
 n 
Cr    Cri  / n
 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 X  K   AX  B   C1  IFA  IFB
Cx is the sample concentration to be test, Ax is the sample absorbance or absorbance

(d) Applicable analysis method
4.6.3 Nonlinear method
Logit-log4P
Suitable for the working curve that absorbance showed convergence with the
concentration increase, Logit-log4P (nonlinear method) calibration curve shown in
figure 4-9:

Calculation method
Absorbance
AN STD(N)
Ax Sample
A3 STD(3)
A2 STD(2)
B
STD(1)
C1 C2 C3 Cx CN Concentration
Figure 4-9 Log 4P calibration curve (nonlinear method)

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: value of the absorbance of calibration fluid 1 or change rate minus B
a, b: Approximation of coefficient, calculate automatically.
S1ABS, K, a, b displayed in the calibration result interface.
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, so C1=0,
IFA&IFB is coefficient of analyzer, which displays the slope and intercept.
(d) Calculation of SD

Calculation method
  A  Ai , 
N 2 2
ij
i 1 j 1
SD 
2N  4
(N=4～6, j=1 or2 )
(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
Logit-log5P
Same characteristic with Logit-log4P, and Logit-log5p has one more calculate
parameter, so the result is more accuracy. Calibration is shown curve as figure 4-10:
Absorbance
AN
A3
Ax
A2
C1 C2 Cx C3 CN Concentration
Figure 4-10 Logit-log5P calibration curve (nonlinear method)

Calibration model:[Logit-log5P]
Calibration points:[5～6](Calibration fluid quantity)
Range point:[0]Range calibration nullity.
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.

Calculation method
 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 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.
  A  Ai , 
N 2 2
ij
i 1 j 1
SD 
2N  5
(N=5～6, j=1 or 2)
Polyline method
Test from fluid 1 to fluid 5 or fluid6, and get the curve line, and link those points
with straight line. As figure 4-11 shown:
Absorbance
STD(6)
STD(2)
STD(1)
C1 C2 CA C6 Concentration
Figure 5-10 Curve of Polyline (nonlinear method)

Calculation method
Calibration model:[Polyline method]

Range point:[0] Range calibration nullity.
S1ABS is average value of twice test for calibration fluid 1 for absorbance or change
value of absorbance.
C2  C1
K
A2  B
B: Absorbance or change rate of Calibration fluid 1.
A2: Absorbance or change rate of Calibration fluid 2.
C1: Concentration of Calibration fluid 1.
C2: Concentration of Calibration fluid 2.
Calculate K2, K3, K4, K5 with same method
C X  K N  ( AX  AN )  CN   IFA  IFB
(d) Applicable methods

Spline 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 figure 4-12:
Absorbance
AN
Ax
A3
A2
C1 C2 C3 Cx CN Concentration
Figure 4-12 Spline method (nonlinear method)

Calibration model:[Spline method]

Calculation method
Range point:[0] Range calibration nullity.

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)
AX  a( I )  b( I )   CX  C ( I )  c(I)   CX  C ( I）   d (I)   CX -C(I) 

3
2
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.
  A  Ai , 
N 2 2
ij
i 1 j 1
SD 
2N  4
(N=5～6, j=1 or 2)

Calculation method
4.7 Prozone check

Prozone Rearzone
Reactivity R
(antigen excess equivalent (antibody excess
zone) zone zone)
Antigen
concentration C
Figure 4.5 Dose response curve of antigen-antibody reaction
In the reaction of the antigen-antibody, the ratio of the insoluble antigen-antibody complex
produced to the antigen-antibody is closely related, and the amount of the insoluble
antigen-antibody complex formed at the appropriate ratio is the largest, and the light transmitted at
the time is the least, which corresponds to the maximum absorbance. When the ratio is less than
this ratio, the amount of the insoluble antigen-antibody complex is reduced, the transmitted light is
increased, and the absorbance is decreased. In this case, the two samples (antigens) having a large
difference in concentration, the amount of the insoluble antigen-antibody complex formed. Can be
equal, if the front test is not carried out, the same measurement results will be obtained. Therefore,
for antigen-antibody reaction, it is necessary to carry out the front test.
The prozone limit refers to the maximum or minimum PC value allowed when there is no
excess antigen.
Prozone check parameters include:
 Prozone limit PCM, and q1、q2
 Prozone check distinction abs. low limit
There are two methods for prozone check: antigen re-addition method and reaction rate ratio
method. The two methods will be described in detail below.
4.7.2 Antigen addition method

The most direct method for judging the excess of antigen is the antigen re-addition method.
Under the premise of antibody excess, the antigen to be tested rapidly reacts with the antibody in
the reaction medium to form stable small complex particles, which generate a scattered light
signal, which increases with the complex. And the extension of time (antibody overdose phase)
and the dynamic enhancement, if the antibody remains in excess within the specified time, the
reaction will continue to increase after the antigen is added again, and the reaction will continue to
rise. If the antigen is excessive, the reaction will decrease. Single and double reagents The project
supports antigen re-addition.
Input prozone check parameters:
Prozone limit PCM, and q1, q2.

Calculation method
The above q 1, q2 are metering points, and satisfy 69≥q2≥41，39≥q1≥end of reaction time.
If one of PCM, q1, and q2 has no input, no antigen re-addition judgment is made.
Sample PC value: PC＝Aq2-k×Aq1.
k is the volume correction factor.
Single reagent project: k＝(VR1+VS)/(VR1+2VS).
Dual reagent project: k＝(VR1+VS+VR2)/(VR1+2VS+VR2).
For the ascending reaction, if the PC <PCM. drops the reaction, if PC> PCM, the front check
abnormal "PRO" mark will be given and the alarm will be given.
4.7.3 Reaction rate ratio method

The reaction rate ratio method is based on the fact that the antibody excess reaction curve can
reach equilibrium in a certain period of time. The antigen excess reaction curve does not reach
equilibrium. The specific judgment method is as follows:
 Prozone limit PCM, and q1、q2
 Prozone check distinction abs. low limit
Sample PC value: . If PC>PCM, give the front check error "PRO" mark
and alarm.
Metering point input requirements:
Single reagent project: 5≤q1 <q2≤33, 5 is the first metering point after mixing the sample.
Dual reagent project: 17≤q1 <q2≤33, 17 is the first metering point after adding R2 to stir..
If one of PCM, q1, and q2 has no input, the reaction rate ratio is not judged.
The system will no longer perform the prezone check if the following two conditions occur:
(Sample end point absorbance - reaction start point absorbance)<【ABS】
Sample reactivity is not within the calibrator response range (valid for sample and QC
tests on non-linearly calibrated items).

5 Reagent application
This chapter describes the functions and operating methods associated with
reagent applications.
32
Reagent application
5.1 Overview
This chapter describes the advanced application functions of the reagent module.
Please select the following operations according to actual needs.
 Reagent allowance alarm limit setting
 Reagent residue detection
 Print reagent information
 Loading reagents
 Replace reagents
 Unloading reagents
5.1.2 Reagent Information Interface Overview

In the menu bar on the left side of the main interface, select [Reagents] to enter the [Reagent
Information] interface. The interface displays the biochemical reagent information.
Figure 5-1 Reagent information

All configured biochemical project reagents are displayed in the list, including the following
information:
Positions: The position of the reagent on the reagent tray.
Item: The project name corresponding to the reagent.
Bottle type: Refers to the R1/R2 reagent bottle specifications.
Reagent type: refers to the reagent type of the multi-reagent item, including: R1, R2.
Remaining: Refers to the remaining amount of each bottle of reagent.
Available: Refers to the remaining measurable number of reagents per bottle.
Reagent application-33
Reagent application
5.2 Reagent margin alarm limit setting

The system will issue an alarm when the reagent balance is below the set alarm limit before
starting the test or during the test.
5.2.2 Reagent margin alarm limit

When the reagent can be measured as 0, the alarm prompts no reagent, and the reagent item
terminates the test. When the reagent can be less than 10, the alarm indicates that the reagent is
insufficient, and the reagent item can still participate in the application and test, and the number of
applications and tests should be less than Measurable number.
5.3 Reagent residue detection

The system supports manual and automatic detection of biochemical reagents. After loading
the reagents, it is necessary to manually perform the margin detection to ensure that the reagents
are sufficient and the test can be carried out smoothly. You can also manually refresh the reagent
balance to the specified position or all positions. The reagent balance is refreshed to the maximum,
indicating that it is available. During the test, the system automatically detects the reagent balance
and refreshes the reagent remaining amount and measurable number on the [Reagent Information]
interface.
Manual margin detection is only allowed when the system is in an incubation or idle status.
Reagent loading or unloading is prohibited during margin detection.
Only when the ―Refresh‖ option on the right side of the ―Reagent Residue Test‖ list box on
the [Reagent Information] screen is selected, the reagent remaining amount and measurable
number on the [Reagent Information] screen will be updated in real time.
5.3.2 Detection reagent balance

1. Select [Reagents] - [Reagent Information].
2. Under the Reagent Residue Test list, click [Start]. Open the [Remaining Detection] dialog
box.
Figure 5-2 Residue of reagent

Reagent application
1) Select the range you want to detect:

 Current specified position: Detects the remaining amount of the selected current
number reagent.
 All positions: Detect the balance of all reagents on R1 reagent tray and R2 reagent
tray.
 Select position: Detect the remaining amount of reagent at the specified position on
the selected disc. Enter the range of reagent number, such as: from 1-10 digits.
2) Select [OK], the instrument automatically detects the remaining amount of reagents
and the remaining test number.
 The remaining amount detection process is displayed in real time in the ―Reagent
Residual Test‖ list box.
 After the test is completed, the remaining amount of reagents and the measurable
number are displayed on the [Reagent Information] screen.
 During the test, the reagent&sample probe is used to absorb the reagent and
simultaneously detect the remaining amount of the reagent. After checking the
―Refresh‖ option on the [Reagent Information] interface, the reagent remaining
amount and the measurable number can be updated in real time.
5.3.3 Manually refresh the reagent balance

Manually refresh the reagent balance, you can specify the position or the reagent balance of all
positions to be refreshed to the maximum, indicating that it is available. Manually refresh the
reagent balance operation by the following method:
1. Select [Monitor] - [Reagent Disk Status] to display the real-time status of the reagent disk.
Figure 5-3 Reagent tray status diagram

2. Refresh reagent tray status:
Reagent application
 Click [One button refresh] to refresh the remaining amount and measurable number of
reagents in all positions to the maximum, and update the status of the entire reagent tray.
 Click [Refresh] to refresh the remaining amount and measurable number of reagents in the
currently selected position to the maximum, and update the corresponding reagent status.
5.3.4 Cancel margin detection

After starting the margin detection, you can cancel the margin detection operation by the
following method:
On the [Reagent Information] screen, click [End] at the bottom of the "Reagent Residue Test" list
box to cancel the margin detection.
5.3.5 Set the reagent balance to automatically refresh

During the test, the reagent&sample probe is used to aspirate the reagent and simultaneously
detect the remaining amount of the reagent, and the [Reagent]-[Reagent Information] interface is
used to set whether to automatically update the reagent balance.
2. Check the [Refresh] check box, the default is to check.
5.4 Print reagent information

When viewing reagent information, you can print all reagent information.
5.4.2 Print reagent information

1. Select [Reagent] - [Reagent Information] - [Print Reagent Location].
2. The "Print" dialog box is displayed.
Figure 5-4 Print dialog

3. Click [OK], the printed reagent information is displayed as follows.
Reagent application
5.5 Loading reagent

Loading a reagent means loading the reagent when the system is in a non-test status. Before
loading, the reagent registration is required. When loading, the reagent can be directly loaded onto
the reagent tray.
Warning:
Please be careful to avoid being pinched.
Biological infection:
Be sure to wear gloves and overalls to prevent infection and wear
Do not touch the reagent directly, as it may cause skin damage or
inflammation.
5.5.2 Reagent registration

Before registering the reagent, you need to complete the corresponding reagent project
parameter setting operation.
The reagent channel of the automatic biochemical analyzer is divided into open channel and
closed channel. The reagent input method of the reagent open channel is to select the reagent
through the drop-down list. The reagent input method of the reagent closed channel is to use the
scanner to scan or manually input the barcode.
 Closed reagent channel reagent information entry
2. Select the reagent tray number and scan the reagent bar code with the scanner to display
the following figure.
Figure 5-6 Closed reagent channel reagent information entry
Reagent application
3. Click [Add]. The corresponding location in the reagent information list box will display
the corresponding reagent information.
4. If the reagent input is wrong, select [Delete] and delete the item to rescan the code.
 Open reagent channel reagent information record
2. Select the reagent tray number, in the [Reagent Information Edit] list box, select the
reagent, bottle size and reagent type information in sequence, as shown below.
Figure 5.7 Open reagent channel reagent information entry

3. Click [Modify], the corresponding location in the reagent information list box will
display the corresponding reagent information.
4. If the reagent input is incorrect, select [Delete] and delete the item and re-enter it.
5.5.3 Loading reagent

2. Place R1 and R2 on the reagent tray.
5.6 Replacement reagent

When the system is in the non-test status, or if the reagent remaining amount is insufficient or
has been used before the test, the reagent replacement should be performed immediately to avoid
affecting the subsequent test.
Warning:
Please be careful to avoid being pinched.
Reagent application
Biological infection:
Be sure to wear gloves and overalls to prevent infection and wear
Do not touch the reagent directly, as it may cause skin damage or
inflammation.
5.6.2 Replacement reagent

2. Remove the reagents that need to be replaced.
3. Put in new reagents.
5.7 Unloading reagent

When some items are no longer carried out, it is allowed to delete the project parameters and
unload the corresponding reagents, and release the position. If you need to re-adjust the reagent
position, you can first unload the reagents and then re-position them. The biochemical reagents
can pass [Reagents]-[Reagent information]-[Delete] function uninstall, special reagents, such as
cleaning solution, are not allowed to be unloaded.
When the project applies for quality control, sample or calibration tests, it still allows to
uninstall all reagents for the project.
After the reagent is unloaded, all information is deleted and the position is released. If the
project has started testing, it is not allowed to uninstall all corresponding reagents.
5.7.2 Unloading biochemical reagents

The operation of unloading biochemical reagents is as follows:
1. Confirm that the item corresponding to the reagent to be uninstalled is not in the test
queue.
3. Select the biochemical reagent you need to uninstall.
4. Click [Delete].
6. Remove the unloaded reagent.
7. Cover the reagent tray cover
Calibration test
6 Calibration test
This chapter describes the various functions and methods of operation related to
calibration, including:
 Calibration parameter settings
 Calibration entry
 Calibration test
 Calibration result confirmation
Calibration test -40

Calibration test
6.1 Overview
Calibration refers to the determination of the reactivity of a known concentration of the
calibrator. Based on the mathematical relationship between the concentration and the
reactivity (ie, the calibration method), the coefficient (ie, the calibration parameter) in the
relationship is calculated to determine the concentration and the reactivity. Specific
mathematical expressions. Ordinary samples are used to determine the sample
concentration based on the known expression of the coefficient and the measured
reactivity.
6.2 Calibration parameter setting

Before logging in the calibration information, you must first complete the corresponding
reagent project parameter setting operation, refer to 3.2.2.
The specific steps for setting the calibration parameters are as follows:
1. In the menu bar on the left side of the main interface, select [Project Parameters] to enter
the "Project Parameters" setting interface, as shown below.
Figure 6-1 [Project parameters] interface

2. Left click on [Scale Parameters] to enter the "Scale Parameters" setting interface, as
shown below.

Calibration test
Figure 6.2 [calibration parameter] interface

3. Click to select the item (such as GLU) that needs to be scaled, and click the [Scale Setting]
button on the right. In the ―Repeat Times‖, ―Scale Mode‖, ―Specimum Type‖, ―Batch
Number‖, ―Density‖, Enter the correct configuration in the "cup number". The standard
number depends on the calibration mode.
Figure 6-3 Calibration parameter setting

4. After the parameter setting is completed, click the [Save] button to complete the
calibration information registration.
6.3 Calibration item directory

The calibration entry directory is as follows:
1. In the menu bar on the left side of the main interface, select [Item Entry] and enter the
[Sample Entry] interface, as shown below.

Calibration test
Figure 6-4 [sample entry] interface

2. Click [Fixed QC Entry] to enter the [Fixed Quality Control Input] interface, as shown below.
Figure 6-5 [calibration quality control entry] interface

3. In the project list box, select the item to be scaled, click the button on the left, and click the
[Save] button on the left to pop up the save dialog box, as shown below.
Figure 6-6 The calibration item is successfully entered.

4. Click the [OK] button to complete the calibration entry.
 If the calibration item is incorrect, you need to delete it. You can select the calibration
item to be deleted in the ―Scale Information‖ list box. Click the left button and click the
Calibration test
[Save] button on the left to pop up the save dialog box. [Confirm] button to delete the
calibration item.
6.4 Calibration test

1. After the calibration item is entered, click the ― ‖ button to pop up the Start Test dialog
box.
Figure 6-7 Start test dialog

2. When the temperature is stable at 37 °C (±0.1 °C), click [Start] to start the calibration test.
 When the ― ‖ button is displayed in the start test dialog box, it means that the test
condition is not met. Putting the mouse on the button will display the corresponding
prompt. According to the information prompt, complete the pre-test check and restart the
calibration test.
3. During the test, the status bar shows the test process, as shown below.
Figure 6-8 Calibration test process

 During the calibration process, if you need to stop the test in case of emergency, just
click the ― ‖ button to stop the test.
6.5 Calibration result confirmation

6.5.1 View response curve
The calibration result reaction curve is a curve of the absorbance return of each reaction
point of the reaction liquid mixed with the calibrator and the reagent in the whole test
period. The steps of viewing the reaction curve are as follows:

Calibration test
1. In the menu bar on the left side of the main interface, select [Data Processing],
click [Response Curve] - [Scale] to enter the calibration response curve
interface.
2. Select the item in the results list for which you want to view the response
curve.
Figure 6-9 View calibration response curve

3. Select a different ratio and zoom in on the response curve.
Figure 6-10 Magnifying the calibration response curve

Calibration test
 You can select the date range as needed, such as

viewing historical response curves.
6.5.2 Query calibration result

1. Select [Project Parameters] from the menu bar on the left side of the main interface, and click
[Scale Parameters] to enter the calibration result query interface.
2. Select the item in the project list for which you want to view the calibration results.
Figure 6-11 View calibration results

 You can select the date you want to view in the time list box as needed to view historical
calibration results.

QC test
7 QC test
This chapter introduces various functions and methods of operation related to QC,
including:
 Overview
 QC rule setting
 QC information login
 QC items
 QC test
 QC results confirmation
 QC adjustment
QC tes-47
QC tes
7.1 Overview
QC test refers to the sample provided by the authoritative department or reagent developer,
and provides the concentration range of various substances to be tested in the sample. The
results obtained by testing the sample on the instrument are compared with the given range.
This determines whether the instrument status is normal and the test result is reliable.
After each calibration test, reagent replacement, maintenance, and troubleshooting
operations, QC testing is recommended to ensure stable instrument performance.
7.2 QC rules setting

The purpose of laboratory QC is to ensure the reliability of each sample. The reliability of the
measurement results includes two aspects of meaning, one is the precision, that is, the results
of the repeatability is good, the laboratory daily changes in the results of small changes,
mainly to eliminate or reduce the impact of random errors. The other is the high accuracy,
that is, the measurement results are correct, close to the true value, the main elimination or
reduce the impact of system error.
Random error: The difference between the measured results and the average of the results
obtained by infinitely many measurements of the same measured under repetitive conditions
is called random error.
System error: Under repeated conditions, the difference between the average of the results
obtained by infinitely many measurements of the same measurement and the measured true
value is called the system error. It is the error component of the measurement result that is
not zero.
Accuracy: Accuracy is the measurement of the system error and random error of the
synthesis, said the measurement results and the true value of the degree of consistency.
Precision: Indicates the degree of random error in the measurement result. Precision refers to
the degree of compliance between the measured results when multiple measurements are
made under certain conditions.
L-J (Levey Jennings) QC chart: The QC chart is a graph with a QC limit. The QC limits are
determined by the mean value ( X ) and standard deviation ( SD ) of the known specimen
(usually the control solution) by the controlled analysis method. X  2SD is the warning
limit, and X  3SD is the loss of control.
7.2.2 QC rules setting

QC rules include: Westgard multi-rule QC, Cumulative Sum Check QC, Twin-Plot
(two-dimensional) QC.
1. Westgard multi-rule QC
QC tes-2
QC tes
 According to the test needs, select Westgard multi-rule QC, pitch on
, pop-up Westgard multi-rule QC rules as shown in

the figure:
Figure 7-1 Westgard multi-rule QC

 The operator according to the test needs, by clicking the way to select the
appropriate QC rules, click the "Save" button to return to the QC results
query window, while the QC rules to save the setting. After setting, in the
"day QC" and "month QC" window will be set in accordance with the
rules of QC data out of control analysis.
 According to Westgard multi-rule judgment benchmark for the measured QC
results, perform out of control analysis. The Westgard multi-rule logic
diagram as shown below
QC data
No
1 2S In control
Yes No
No No No No
1 3S 2 2S R 4S 4 1S 10 -
x
Yes Yes Yes Yes Yes
Out of control
Figure 7-2 Westgard multi-rule logic diagram

Sheet 7-1 Determine the baseline description
Result Out of control

QC rules Description
marker symbols
QC tes-3
QC tes
Indicating that there is a test result in the

1 2S no no
control over 2 ±2SD, but less than ±3SD
Indicating that there is a test result in the

1 3S 1 3S *⑴
control over ±3SD
Indicating that there are two consecutive test

2 2S results in the QC over +2 SD or -2SD, such as 2 2S #⑵
(Xn, Xn-1)
That there is a test results in more than +2 SD

R 4S R 4S #
test results, another test results more than -2SD
Indicating that there are four consecutive test

4 1S results in the control over + 1 SD or -1 SD, 4 1S #
such as (Xn, Xn-1, Xn-2, Xn-3)
Indicating that there are 10 consecutive test

10 results (10 data) on the same side of the mean, 10 #
X X
such as (Xn, Xn-1, Xn-2…Xn-9)

(1) "*" Means random error, you can not take any operation, but still can not be
ignored.
(2) "#" Indicates system error and needs attention.
2. Cumulative Sum Check QC
Cumulative Sum Check QC rules are as follows:
1) Calculate K value (±1SD) and control limit H (2.7SD) according to the QC target
and standard deviation.
2) When the QC value does not exceed the K value, the cumulative sum is not
calculated.
3) When the QC value exceeds the K value (greater than the upper limit or less than the
lower limit) of the data points, began to accumulate and calculate.
4) For the subsequent points, continuous calculation of cumulative sum.
5) Calculate, accumulate and clear when accumulating and just changing the symbol
(positive or negative) and accumulate the sum for the subsequent data points.
6) When the accumulated and over control limit H (greater than the upper limit or less
than the lower limit), then judged to be out of control.
3. Twin-Plot (two-dimensional) QC
QC tes-4
QC tes
Twin-Plot (two-dimensional) chart to the QC X test results for the horizontal

axis, QC Y test results for the vertical axis, will participate in the joint test
results for the vertical axis, will participate in joint judgment of the two QC,
and the same batch of test results are plotted to determine system errors and
random errors.
7.3 QC information login

The specific operation steps for the QC information login are as follows:
1. Select [Item Setting] in the menu bar on the left side of the main interface, and click [QC
Parameter] to display the following figure.
Figure 7-3 [QC Parameter] interface

2. Click [Add] and enter the batch number of the control item in the "QC Lot No." input box.
Select the item that needs QC in the ―Optional Items‖ list, click the ― ‖ button to add
the optional item to the ―Selected Items‖ list. After the completion of the series, click "Save",
the display interface is as shown below.
QC tes-5
QC tes
Figure 7-4 QC information login

3. Modify the ―TargetValue‖ and ―standard deviation‖ of the corresponding project according
to the QC manual. After the modification is completed, the QC information registration
operation can be completed.
7.4 Quality control item directory

After the quality control information is registered, you can enter the quality control item directory
as follows:
1. In the menu bar on the left side of the main interface, select [Item Entry], click [Fixed QC
Entry], and open the calibration quality control item directory interface, as shown below.
Figure 7-5 [Quality Control Input] interface

2. Click [Add] in the quality control area on the right side of the interface, select the batch
number of the control item in the "Quality Control Lot Number", and enter the bit number of
the quality control item placed in the sample tray in the "Quality Control Number".
3. In the project list box, select the item that needs quality control. Click the button‖ ‖ on
the right and click the [Save] button on the right to display the following.
QC tes-6
QC tes
Figure 7-6 Quality Control Item Directory

4. The ―QC List‖ displays the quality control of the edit (such as List 2) and completes the
operation.
5. If the quality control item is incorrect, you need to delete it. You can select the list to be
deleted in the ―Quality Control List‖ box. After clicking the [Delete] button, the delete
confirmation dialog box will pop up. Click the [OK] button to delete the quality control list..
7.5 Quality control test

1. After the quality control item is entered, click the ― ‖ button to pop up the Start Test
dialog box.

2. 2. When the temperature is stable at 37 °C (±0.1 °C), click [Start] to start the quality
control test.
When the ― ‖ button is displayed in the start test dialog box, it means that the test
condition is not met. Putting the mouse on the button will display the corresponding
QC tes-7
QC tes
prompt. According to the information prompt, complete the pre-test check and restart
the quality control test.
3. During the test, the status bar displays the test process as shown below.
Figure 7-8 Quality Control Test Process

During the quality control process, if you need to stop the test in case of emergency, just
click the ― ‖ button to stop the test.

4. After the quality control test is completed, the instrument automatically calculates the
measured mass control target value (average value), standard deviation, coefficient of
variation and other data.
N
 Xi
i 1
Target( X ): N
N
  Xi  average 
i 1
2
Standard deviation(SD): N 1
SD
 100%
Coefficient of variation(CV%): average
Deviation: Xi－(average)
Deviation
 100%
%Error: average
Among them:
N is the number of measurements, Xi is the test result.
7.6 QC results confirmation

7.6.1 View response curve
The quality control result reaction curve viewing steps are as follows:
1. In the menu bar on the left side of the main interface, select [Data Processing], click
[Response Curve] - [Quality Control], enter the quality control response curve interface.
2. Select the item in the results list for which you want to view the response curve.
QC tes-8
QC tes
Figure 7-9 Viewing the QC reaction curve

1. Select different ratios and zoom in on the reaction curve.
Date range can be selected as needed, such as

check historical reaction curve.
7.6.2 Query QC Result

1. Select [Data Processing] in the menu bar on the left side of the main interface, and click [QC
Result Query] to enter the QC result query interface.
Figure 7-10 [QC Result Query] interface

1. Select the item to be queried in the item list, and select the QC batch number, and the QC
result can be queried according to the time of the QC test.
2. Select different QC rules to view the corresponding QC charts as follows.
QC tes-9
QC tes
Figure 7-11 Westgard multi-rule QC results query figure
Figure 7-12 Cumulative Sum Check QC Results Query figure
Figure 7-13 Twin-Plot (two-dimensional) QC results query figure
QC tes-10
QC tes
7.6.3 Analysis of out of control

1. The chemical analyzer system proceeds out-of-control analysis of the QC results. The
specific operations are as follows:
1. Select [Data Processing] in the menu bar on the left side of the main interface, and click
[QC Result Query] to enter the QC result query interface.
2. Click [Out of Control Analysis], the results will be displayed in the right window, as shown
below.
Figure 7-14 Analysis result of out of control

7.6.4 Printing QC Chart
2. Click [Print QC Chart] to print the daily QC or monthly QC figure.
7.6.5 Printing QC Report

2. Click [Print QC Report] to print the daily QC or monthly QC figure, as shown below.
Figure 7-15 Print QC Report

1. Click [Print], can print QC report.
QC tes-11
Sample test
8 Sample Test
This chapter describes the various functions and operation methods related to sample testing,
including:
Sample test
Modify/append sample and project tests
Sample retest
Load/unload sample
Cancel sample request
View sample tray location
Sample results viewing and processing
Sample test-2
Sample test
8.1 Overview
The system applies sample testing for the reagent&sample tray and supports the following test
methods, including: single sample application, batch application, retest application, additional
application, and emergency application. The applied test project may be a single biochemical
project, a computing project, or a project portfolio composed of commonly used projects. Before
starting the sample analysis, you can set the project test properties as needed. during the test, input
patient information and view the sample test status. The system also provides the function to
delete samples and their application information and test results.
These features and operation methods are detailed in the following sections.
8.2 Sample Test Method

8.2.1 Introduction
In addition to the test methods of conventional samples, it is often necessary to add samples and
projects during the test, or to retest an abnormal sample.
8.2.2 Sample entry

Improper use of the sample may result in infection. Do not touch the sample
directly with your hands. Always wear gloves and overalls when handling to
prevent infection and wear protective glasses if necessary. If the sample is
inadvertently in contact with the skin, immediately follow the user's work
standards and consult a doctor.
Do not touch the reagents directly, as this may result in skin damage or
inflammation.
Precaution:
Do not use expired samples, which may result in inaccurate measurement

results.
Sample entry is required before the sample test, as follows:

1. In the menu bar on the left side of the main interface, select [Sample Entry] to display the
―Sample Entry‖ interface.
Sample test-2
Sample test
Figure 8-1 [Sample Entry] Interface
The system can enter a single sample or batch sample, as well as a combination of items.
Single sample entry: Click [Add], and select the items to be tested in the upper left column, click
the button, and then select to the "Selected test items" list column. The sample bit number
generally starts from 1 and is accumulated in turn. The serial number cannot be repeated, and the
patient's information ―name‖, ―gender‖, ―age‖, etc. are filled in order, and the information such as
―sent inspection department‖, ―sample type‖, ―to be sent to the doctor‖ is edited. After the login is
completed, click [ Save] to complete the operation.
Batch sample entry: If there are multiple samples, you need to test the same project. You can use
batch input, put the samples on the sample tray continuously, click [Batch Entry], fill in the
quantity to be tested in the ―Bulk Entry‖ information input box. Start number, as shown below.
The sample bit number input starts from 1 to 37, and the sample bit number changes from 37 to 1
and then increments from 1. In the upper left column, select the items to be tested, click the button,
select to the "Selected test items" list column, and click [Batch Save] to complete the operation.
Figure 8-2 Batch Entry Input Box

Combination item entry: If the selected item is a combined item that has already been set in the
process of entering the sample, you can directly select it in the combination column on the lower
left side. Click the button to add it directly to the "Selected Measurement Items" column.
8.2.3 Additional Sample Test

Sequence mode:
Additional samples in sequential mode requires consideration of if the sample numbers are
continuous to avoid mixing sample numbers and invalidation of test results.
1. Add a new sample test in accordance with the 2.8.1 regular sample test.
2. Confirm the sample application information is correct.
3. Place the additional sample on the sample tray.
Click on the top left corner of the interface, the start test dialog box will pop up, then click
[Start] to start the test.
Sample test-3
Sample test
8.2.4 Modify/ Add Testing Items

Whatever the sample is in any status, you can add the items and test, also can set the number of
repetitions for the added project. When the applied sample has not yet started testing, the system
allows modification of the sample information, patient information and project application
information. If the sample is in the "testing", "retest", "unfinished" or "completed" status,
modification of sample information and project application information is not allowed, only
patient information and additional project tests can be modified.
1. In the menu bar on the left side of the main interface, select [Item Entry] to display the
―Sample Entry‖ interface.
2. In the "Input Samples" list box, select the sample number to be modified, and display the
sample application information in the "Selected Test Items" list box.
3. Click [Modify] / [Add] to modify or add sample information and project information.
automatically start testing.
If the system is in the "standby" status, click the button in the upper left corner of the
main interface to start the test.
8.2.5 Sample retest

After the sample test is finished, the system allows the sample to be retested. Only retesting of the
project at the end of the test is allowed. Retest can be performed on the [Sample Entry] interface
and the [Report Print] interface.
8.2.5.1 Sample Retest for the “Sample Entry” interface

Sample retesting is performed on samples that are ―completed‖, ―unfinished‖, ―retested‖, and
―tested‖ by the [Retest] option on the [Sample Entry] interface. When retesting, it is allowed to
modify the sample cup type, sample position, emergency attributes and test items of the sample. If
the item has been tested before the test, the sample size and the number of repetitions are allowed
to be retested. If the sample is retested before the sample is retested modifying project information
is not allowed without testing completion.
1. In the menu bar on the left side of the main interface, select [Item Entry] to display the ―Sample
Entry‖ interface.
2. Check the [Retest] check box.
3. Select the sample number that needs to be retested and click [Modify].
4. Select the items that need to be retested.
5. Click [Save] to complete the retest sample or item directory entry.
Sample test-4
Sample test
Figure 8-3 Sample retest on the [Sample Entry] interface
8.2.5.2 Sample Retest for the Report Print interface

Sample retesting is performed on samples that are ―completed‖, ―unfinished‖, ―retested‖, and
―tested‖ by the [Save Retest] option on the [Data Processing] screen. When retesting, it is allowed
to modify the sample cup type, sample position, emergency attributes and test items of the sample.
if the item has been tested before the test, the sample size and the number of repetitions are
allowed to be retested. if the sample is retested before the sample is retested modifying project
information is not allowed without testing completion.
1. Select [Data Processing] in the menu bar on the left side of the main interface to display the
"Report Print" interface.
2. In the "Sample No." list box, check the sample number to be retested.
3. In the project information list box, check the items that need to be retested.
4. Click [Save Retest], the save success dialog box will pop up, and the sample retest setting can
be completed.
After the sample retest is successfully set, ―Yes‖ is displayed in the ―Retest‖ list.
Figure 8-4 Sample retest on the [Report Print] interface

If the system is in the process of testing, the retested samples will automatically enter the test
project.
If the system is in the ―idle‖ status, click the button in the upper left corner of the main interface to
start the test task of retesting the sample.
When the sample retest test is not performed, if you need to cancel the sample retest, click [Reset
Sample test-5
Sample test
Retest].
Only the current day can be re-tested.
8.2.6 Sample Processing

Before starting to apply for a sample, it is necessary to understand the sample cups and
sample cup types and sample sizes supported by the system to understand how to load the
samples.
Sample cup type:
The reagent&sample tray holds the original blood collection tube, sample cup, and
microcup.
Sample size:
The sample size required for the analysis was 2 to 70 μl, and the increase was 1 μl. If it
is below this range, accurate test results cannot be obtained.
During the test, if the sample is exhausted, the system will automatically invalidate all
items in the sample that have not been sampled. Therefore, please ensure that the
sample size is sufficient when preparing the sample to ensure the test goes smoothly.
Load the sample into the reagent&sample tray.

Chemical Infection Risk:
When handling, be sure to wear gloves and overalls to prevent infection and
wear protective glasses if necessary.
1.Confirm that the sample size in the sample cup meets the test requirements.
2. Confirm system status:
status, click the button in the upper left corner of the main
interface, and then perform the next step.
tinue to the next step.
3. Confirm that the sample tray and reagent&sample probe have stopped moving.
4. Open the sample tray cover.
5. Insert the sample cup into the sample tray until the bottom of the sample cup is in full contact
with the annular groove of the lower ring of the sample tray.
6. If you need to continue loading more samples, load the sample cup according to step 5 until the
loading is completed.
7. Install the sample tray cover.
Loading samples from the reagent&sample tray
When handling, be sure to wear gloves and overalls to prevent infection and
wear protective glasses if necessary.
1. Confirm that the sample tray and reagent&sample probe are in a stopped status.
2. Confirm system status:
f the system is in the test status, click the button in the upper left corner of the main interface,
and then perform the next step.
3. Open the sample tray cover.

4. Hold the sample cup by hand and lift it up vertically to remove it.
5. If you need to uninstall other samples, follow step 4 to unload the sample cup until the
uninstallation is completed.
6. Install the sample tray cover.
Sample test-6
Sample test
8.3 Cancel Sample Test

8.3.1 Introduction
After applying for the sample, if the sample has not started testing or some items have not been
tested, you can delete the application information by ―delete‖ function. You can delete single or
multiple samples at the same time. After the sample is cancelled, the sample information will be
permanently deleted and the sample number and can be reused for the sample application.
8.3.2 Cancellation of sample application
1. In the menu bar on the left side of the main interface, select [Item Entry] to display the [Sample
Entry] interface.
2. In the "Input sample" list box, select the sample number to be deleted, you can select a single
sample or multiple samples.
Figure 8-5 Interface of canceling the sample test

1. Click [Delete] to pop up the delete confirmation dialog box.
Figure 8-6 Delete confirmation dialog

2.Click [OK] to cancel the specified sample test.
If the sample has not yet started testing, delete the sample number in the Input Samples list box.
If some items are not tested during the test, the sample number is retained in the ―Input Sample‖
list box, and only the untested items in the sample are deleted.
8.4 Sample Test

After the sample entry is completed and loaded on the reagent&sample tray, the temperature is
stable. After the other test conditions are set, the sample test can be performed as follows:
1. In the upper left corner of the main interface, the " " button pops up to start the test dialog
box.
Sample test-7
Sample test

2. When the temperature is stable at 37 °C (±0.1 °C), click [Start] to start the sample test.
When the ― ‖ button is displayed in the start test dialog box, it indicates that the test condition
is not met. Putting the mouse on the button will display the corresponding prompt. According to
the information prompt, complete the pre-test check and restart the sample test.
1. During the test, the status bar displays the test process as shown below.
Figure 8-8 Sample Testing Process

8.5 View sample tray location
8.5.1 Introduction
The system can view information on the sample tray with or without sample locations, as well as
sample status information.
8.5.2 Viewing the Sample Disk Location
In the menu bar on the left side of the main interface, select [Monitor] to display the "Sample
Palette Status" interface.
Sample test-8
Sample test
Figure 8-9 [Sample tray status] interface

1. View the sample tray position and status information, where the sample tray uses different
colors to distinguish the status of the sample:
Idle: the sample tray is not loaded with samples at this location.
unchecked: the sample has not been tested.
Positive inspection: The sample is being tested and has not been tested.
Checked: the sample has been tested
Emergency: the sample is an emergency department.
Retest: The sample is a sample for retesting.
QC: the QC items are loaded at the position of the sample tray.
Calibration: The sample tray is loaded with calibrators at this position.
No sample: no samples were detected during the sample test.
8.6 Test result query

8.6.1 Introduction
You can view and process the test results of regular samples, emergency samples and QC samples
through the [Report Print] or [Test Results Query] interface, and print the test results. Based on the
"Date" selection, you can display all sample results for the application and test of the day. or all
previously applied and tested samples.
8.6.2 Sample test results view
8.6.2.1 [Report Print] Interface Test Results Query
1. Select [Data Processing] in the menu bar on the left side of the main interface to open the
[Report Print] interface, as shown below.
Sample test-9
Sample test
Figure 8-10 [Report Print] interface test result query

4. According to the "date", you can choose to view the current test results and historical test
results.
Figure 8-11 Date choose
Figure 8-12 History test result query

8.6.2.2 [User Management] Interface Test Results Query
1. In the menu bar on the left side of the main interface, select [User Management], open the
[Test Results Query] interface, as shown below.
Sample test-10
Sample test
Figure 8-13 Test results of the [User Management] interface

1. According to the ―date‖ or name, click [Query] to select the current test result and historical
test result.
Figure 8-14 Historical test result query
Sample test-11
9 Data Processing
This chapter describes the backup of various test result data, print template settings, Auto
printing and manual printing methods, and describes the style of printing reports.
The report examples provided in this chapter are for demonstration purposes only. Please
refer to the actual printed report.
Data processing
9.1 Data Output

9.1.1 Introduction
The system supports data export and imports or exports various data through mobile storage
devices. Exporting data is allowed only when the system is in standby and fault conditions.
The export function allows you to export the following data for backup:
Sample results, including all duplicate test results - backed up by transmission to the LIS host
QC results - backup by transmission to the LIS host
QC data - backup to mobile storage
Calibration results - backup to mobile storage
Open reagent project parameters - backup to mobile storage
9.1.2 Derived Data to LIS Host

The system supports data transfer with the LIS host for auditing and backup. The system supports
real-time and manual sending of sample results and QC results to the LIS host for review and
backup. Real-time transmission means that after the sample test is completed, the system
automatically sends all test results of the sample to the LIS. Manual transmission allows.
Through the results query interface, query the desired results and then transfer them to the LIS.
Exporting data is allowed only when the system is in standby.
Precaution:
Do not turn off the analysis main power or exit the operating software
during data export.
1. Select [Data Processing] - [Data Export].
2. Check the data before exporting the data.
3. Select its export mode, network port or serial port in the [Export Mode] drop-down menu.
4. Network port export:
Select the network port export mode, you need to set the corresponding server address, port
number, encoding format and other data.
Confirm whether it is transmitted in real time.
Then click [Connect] to check whether the status is connected successfully.
Serial port export:
Select port export mode, you need to set the corresponding port and baud rate.
After clicking [Open], a prompt box for confirming whether to transmit in real time will appear. If
you need real-time transmission, click [OK], otherwise click [Cancel].
Figure 9-1 LIS transmission settings

5. After finished setting, click [Save].
Data processing -2
Data processing
9.1.3 Data Backup

The system provides data backup function, which allows data such as data results to be backed up
to mobile storage devices (such as U disk, floppy disk, etc.) for archiving and later viewing.
The statistics in [Data Statistics] of [User Management] can be backed up.
Such as: test statistics, workload statistics, cost statistics
Test statistics:
[Test Statistics] The statistical methods can be divided into sample statistics and project statistics.
After confirming the statistics mode, start time, and end time, click [Statistics] to list related data
in the sample list, and click [Export]. The data can be backed up. The backup file is named by
default with the date and time of the backup. The format is .csv.
Figure 9-2 [Test Statistics] interface

Workload statistics:
[Statistics of the workload] can be divided into statistics according to the examiner or the
submitter. after confirming the statistical conditions, click [Statistics] to list the relevant data in the
sample list, and click [Export] to perform the data. Backup, the backup file is named by default
with the date and time of the backup, and the format is .csv.
Figure 9-3 [Statistics of the workload] Interface

Total expenses:
The statistical method of [cost statistics] can be divided into patient charge statistics and cost
accounting statistics. click [price] to set the cost price and charge price of the project. after
confirming the statistical method, statistical conditions and sample number, click [Statistics] to
Data processing -3
Data processing
The relevant data is listed in the sample list. Click [Export] to back up the data. The backup file is
named by default with the date and time of the backup. The format is .csv.
Figure 9-4 [Cost statistics] Interface
9.2 Print Setting
9.2.1 Introduction
Various test results and data can be printed out via the printer and the specified template. Can set
the printer type and default.
Identify the printer and the order in which the items are printed.
9.2.2 Changing the print paper type
Open the biochemical instrument software installation folder, find the configuration file
, open the configuration file config.ini to find the field [print page], set the print
paper type, select the paper type as A4_zh, A5_zh, B6_zh, if the paper type is set to A5_zh, field
[ The print page] configuration information is set to A5_zh, for example .
9.3 Sample Report Printing

9.3.1 Introduction
The sample report is used to print test results, sample lists, reaction curves and data for patient
samples, as well as sample blanks.
Should curve and data.
The printing method and report form of the report are detailed below.
9.3.2 Sample report

The sample report prints the results of all project tests for a sample into a single report, including
emergency samples, regular samples, and QC samples. And you can choose from multiple types
of printing, such as: single sample report printing, batch sample report printing, etc., the report can
be printed through the following interface:
Method one:
Data processing -4
Data processing
Figure 9-5 [Report Printing] Interface

Follow the steps below to print a sample report:
1. Select [Data Processing] - [Report Print].
2.the left selection bar can select the sample to be printed.
3. There are 5 printing ranges in the lower part of the interface to choose from.
Current: Select [Current] to print the report of the patient information displayed on the current
page.
All: Select [All], all reports of this batch test are printed.
Picture mode:
In order: select [in order], that is, report printing according to the current list order.
Print range: Select [Print Range], that is, we can print some sample reports needed by entering the
relevant sample number below.
4. Click [Print].
Figure 9-6 Print Smaple Result
Data processing -5
Data processing
Method two:
1. Select [User Management] in the menu bar on the left side of the main interface to open
the "Test Results Query" interface, as shown below:
Figure 9-7 [Test Results Query] interface

2. According to the "date" or name, click [Query], you can choose to view the current test results
and historical test results.
3. Click [Print].
9.4 Reagent report Print

9.4.1 Introduction
The reagent report is used to print a list of biochemical reagents, as well as the reagent location,
reagent type, margin information, and calibration status.
9.4.2 List of biochemical reagent information
The biochemical reagent calibration list report can be printed through the biochemical reagent
information interface.
1 Select [Reagents] - [Reagent Information]
2 Click [Print Reagent Location] to print.
Figure 9-8 Biochemistry reagent sheet
Data processing -6
Data processing
9.6 QC Report Print

9.6.1 Introduction
The QC report is used to print data related to QC results, including QC test results,
Levey-Jennings chart, Twin-Plot diagram, QC data and QC data summary.
9.6.2 QC Result
After the QC test is finished, you can select the print result and print it through the [Data
Processing] interface.
1. Select [Data Processing] - [QC Result Query].
2 Query the QC result that needs to be printed.
3 Select the QC result.
4 Click [Print QC Chart] or [Print QC Report].
Figure 9-9 QC chart
Figure 9-10 QC result report
Data processing -7
Item parameters
10 Item Parameters
This chapter introduces the various advanced application functions of the project. Its main
purpose is to integrate some of the results tested by other instruments into one inspection
report. include:
Manually enter project settings and applications
Calculation project settings and applications
Combination project setup and application
Item parameter -8
Item parameter
10.1 Manually entering project settings and applications

10.1.1 Introduction
Manual input items can be manually input into the test report after the results are obtained from
other instruments, such as: hepatitis B, electrolytes (K+, Na+, Al3+, Ca2+).
Figure 10-1 Entering a project manually

10.1.2 Design / Edit Manual Input Project
1. Click [Project Parameter] - [Special Item Parameter Settings].
2. Click [Add] in the manual input project.
3. Edit the project abbreviation, normal high value, normal low value, project full name, decimal
place, unit in turn.
4. After the setting is completed, click [Save].
5. If you want to re-edit, click [Cancel].
10.1.3 Entering results of manual input items
In [Data Processing] - [Report Print], select the manual input item added before, and add the result
and prompt.
10.2 Calculation project settings and applications

10.2.1 Introduction
The calculation item is the measurement result of two or more items A and B, and the
measurement result of another new item is calculated.
10.2.2 Design / Edit Calculation Project
2. Click [Add] in the lower left side of the calculation project combination box.
3. Fill in the project number by serial number in sequence, and fill in the project abbreviation,
Chinese full name, and English full name according to the user's needs. Fill in the unit of
measurement, normal high value, normal low value, decimal number, and calculation formula
according to the project instructions added as needed.
Figure 10-2 Calculation project

10.2.3 Calculation of project results
In [Data Processing] - [Report Print], select the previously added calculation item and add the
result and prompt.
10.3 Combined project setup and application
10.3.1 Introduction
The so-called project portfolio is to combine related projects and naming them together, such as: a
complete set of liver function, a complete set of kidney function, etc. If you need to complete a
Item parameter-2
Item parameter
full set of liver function and a full set of kidney functions, just click on the name of the project
portfolio. Complete the registration function of multiple items to facilitate quick entry during
sample registration.
Figure 10-3 Combined Project

10.3.2 Design/Edit Combination Project
2. Click [Add] in the combination box of the lower left side combination item.
3. Fill in the project number according to the serial number in sequence, and fill in the project
abbreviation and the full name of the project according to the user's needs.
4. Select the test item in the list of selectable items and import it into the selected test item by the
left and right direction arrows.
10.3.3 Entry of results of combined projects
In [Data Processing] - [Report Print], select the previously added combination item and add the
result and prompt.
Item parameter-3
11 System Function
This chapter describes how to perform various instrument commands and advanced system
settings to make better use of the instrument.
Advanced system setup options include:
System function
11.1 User and password settings

11.1.1 Introduction
The [User and Password] interface allows you to add, delete, and modify operating software users,
set user permissions, and assign user groups. The advanced permission group can set different
permissions for each user of the normal permission group, allowing them to perform operations
corresponding to the assigned rights.
Description:
The user privilege level is divided into three levels: normal, advanced, and super advanced.
Ordinary permissions are used by hospital operators, advanced privileges are used by hospital
administrators, and super-privilege is used by customer service engineers.
The advanced permission group can set different permissions for each user of the normal
permission group, allowing them to perform operations corresponding to the assigned rights.
If the normal privileged user password is forgotten, you can log in to the system as an advanced
privileged user, delete the username, and then reset it. or contact the company's customer service
department or the distributor in your area. If the administrator password is forgotten, please
contact the company's customer service department or distributor in your area.
11.1.2 Adding Users

Only advanced users can add new users, which are not allowed by the operator. A maximum of
100 users, including 1000, are allowed. User code, user name, and level are required to add users.
1. Select [User Management] - [User Management].

2. Enter the user code in the [User Code] field.
3. Enter the user name in the [User Name] field.
4. Select the level of the user in [Level].
Options include:
advanced.
ordinary.
5. Click [Add].
6. After the user adds, a related prompt box will pop up, showing ―User added successfully, initial
password is 12345‖, click [Confirm].
Figure 11-1 User add successfully interface

11.1.3 Deleting Users
Users who are currently logged in to the operating software are not allowed to delete. Except for
advanced users, other users do not have permission to delete users. If you want to modify the
permissions or user name and user code, you can delete the user and then add it again.
System function -2
System function
1. Select [User Management] - [User Management].

2. Select the user you want to delete in the user list.
3. Click [Delete].
4. Click [OK].
11.1.4 Changing the password
Changing the password can only modify the user password of the currently logged in
operating software.
Figure 11-2 Modify password interface

1. Select [User Management] - [Modify Password].
2. Enter [original password], [new password], [confirm password].
3. Click [OK].
4. The ―Password modification successful‖ prompt box appears, click [OK].
11.2 version information

Open the [About] interface, query and introduce the software version and machine number, as
shown in Figure 11-3.
Figure 11-3 Version Checking
System function -3
12 How to Use LIS
This chapter introduces the communication parameter settings of the Laboratory

Information Management System (LIS) and the sample test and result transmission method
for connecting the LIS.
How to use LIS
12.1 Overview
This chapter describes how to use LIS.
The Laboratory Information System (LIS) is an external host connected to the analyzer through a
fixed interface for downloading sample application information to the analysis module and
accepting sample test results transmitted from the analysis module.
Before using the LIS to download sample application information and transmit sample results, you
need to set the communication parameters of the LIS and the result transmission method.
Before using the LIS feature, make sure you have selected the LIS. If not, please contact our
customer service department or distributor in your area.
12.2 LIS communication parameter settings

12.2.1 Introduction
Before using the LIS, you need to set the communication parameters of the LIS, such as:
transmission mode, IP address, port, etc. Before obtaining the sample application information and
the transmission result from the LIS, the correspondence relationship between the LIS system and
the project parameters in the analyzer must be set, and the corresponding code is used as the
contact link. Otherwise, the LIS cannot recognize the project uploaded from the analyzer, and the
analyzer cannot recognize the slave. LIS downloaded project.
12.2.2 Setting LIS Communication Parameters

1. Select [Data Processing] - [Data Export].
2. Set the following communication parameters:
Table 12-1 LIS communication parameters

Select the transfer method of the analyzer and LIS host
Transfer Method from the drop-down list. The options are: Serial and
Network (TCP/IP). The default is serial (Serial).
Inpt the IP address of the LIS host. The connection
Server IP address between the analyzer and the LIS host is implemented via a
network and is connected based on the TCP/IP protocol.
Port Input the port number of the LIS host.
When selecting the serial port as the transmission mode,
you need to set the following serial communication
Serial
parameters:
communication
parameters
the default is 19200
Select the encoding format of the analyzer connected to the
Encoding format LIS host from the drop-down list. including: ASCII, UTF8,
Unicode, UTF32
3.Click [Save] to save the settings.
12.3 Sample test connected to LIS

12.3.1 Introduction
After connecting with the LIS, you can send sample application information from the LIS, or
apply for regular sample and emergency sample test by real-time scanning and manual download,
and then transfer the result to the LIS host in real time or manually for review and archiving.
There are two cases in which the LIS actively sends the application information and manually
downloads the application information from the LIS: there are barcodes and no barcodes. If the
sample barcode system is selected, after obtaining and downloading the application information,
the system can Automatically identify the sample by scanning. if the barcode system is not
How to use LIS-2
How to use LIS
selected, after obtaining and downloading the application information, it is necessary to manually
set the location for the sample.
12.3.2 Sample Testing Connected to LIS

The system supports real-time and manual download of sample application information from the
LIS, and then starts testing. When the system is in standby, you can manually download the
application information from the LIS.
The sample information system downloaded from the LIS will overwrite its project. if the sample
is in another status, the system will append the new project.
Figure 12-1 Sample connection LIS interface

1、 Click [Item Entry] - [Sample Entry].
2、 In the [Input Sample] list, right-click the sample number of the test data you want to
import from the LIS system and select [LIS].
3、 After the import is successful, click [OK].
4、 Click [Save].
How to use LIS-3

13 Maintenance
This chapter describes how to maintain the instrument, including common maintenance
instructions and regular maintenance. A detailed description of the purpose of each maintenance
project, timing of use, required supplies, instrument status, precautions, and operating procedures
are provided.
maintenance
13.1 Overview
13.1.1 Introduction
To ensure reliable performance, good working condition and longevity of the system, please
operate and regularly maintain the system in strict accordance with the requirements of this user
manual. Even if you are only an operator, it is important to understand the maintenance and
troubleshooting knowledge in this chapter. In-depth study will enable the instrument to achieve
optimal operation and optimum performance during use.
The system provides biochemical maintenance instructions and maintenance lists. Through the
maintenance command, you can perform various maintenance operations on the instrument. You
can use the maintenance list to master the periodic maintenance items, record the time and content
of each maintenance, and record the abnormalities or other important events that occur during the
maintenance process for later review. For unresolved problems encountered during use and
maintenance and repair issues not covered in this chapter, please contact the company's customer
service department or the distributor in your area.
Warning:
Do not perform maintenance work that is not explicitly stated in this chapter.
Failure to do so may result in system damage and personal injury.
Do not touch parts that are clearly documented and can be operated and
maintained by the user.
Unauthorized repairs to the system can result in system damage and personal
injury, and the terms promised in the repair contract are no longer valid.
After the maintenance work is completed, please confirm that the system is
working properly.
Do not spill liquids such as water or reagents on the mechanical or electrical
parts of the system.
If you do not use the instrument for a period of time (more than one week) or
need to move the instrument, please contact the company's customer service
department or the distributor in your area to perform on-machine maintenance
to ensure that the instrument will still perform well after the next power-on.

During maintenance work, be sure to wear gloves, work clothes to prevent
13.1.2 Accessories Information

To ensure personal safety and to ensure system performance, please use the accessories
manufactured or recommended by the company. If you need instrument repair or replacement of
accessories and consumables, please contact our customer service department or distributor in
your area.
Table 13-1 Accessories Information
Spare Part Position Note
Replace parts regularly. Replace when using more
than 2000 hours or when the system indicates that
Light source
Halogen lamp 6V 10W the light source is not strong enough. It is
box
recommended that each light source be used for
no more than 6 months.
Cuvette (8/group*6 groups) Reaction Tray Used to reaction between reagents and samples
maintenance-5
maintenance
Polyurethane hose Water pipe 3.2mm×6.4mm

Water supply filter, water
Water supply piping
drop
Reagent&sample probe Sample arm Suction sample and reagent
Stirrer Mixing arm Mixing reagent and sample
Washing part washing probe Washing arm Washing cuvette
Reagent&sample probe Washing
cleaning tank
Stirring probe cleaning tank
drop
Washing part washing probe
reagent&sample probe
Stirrer
Sheet for user regularly replace or maintenance spare parts
Please prepare the following parts as backup in order to repair in time when the instrument
fails, see Table 13-2:
Table 13-2 Regular Accessories
Recommended
No. Spare part Note
stock / year
1 Halogen lamp 6V 10W 1
Cuvette (8/group*6
2 24g roups
groups)
3 Polyurethane hose 3.2mm×6.4mm 10m
4 Water supply piping 2
drop
5 Reagent&sample probe Suction reagent and sample 1
6 stirrer Mixing reagent and sample 1
Washing part washing
7 Washing cuvette 1
probe
13.1.3 Maintenance supplies and tools
The following supplies and tools are required to maintain the instrument.
Standard supplies and tools
Table 13-3 Standard supplies and tools
Supplies and tools Applicable range
Remove the housing and cooling fan
Phillips screwdriver φ3.3×75
Install needle and light source
Install/disassemble the needle and
Slotted screwdriver φ3.3×75
install the hoop
Set of inner hexagonal wrenches M2~M6 Install/disassemble arm
Nozzle Cleaner 0.3mm, 0.5mm Cleaning pin
Supplies and tools that users must prepare
Table13-4 Supplies and tools that users must prepare
Supplies and tools Applicable range
Clean gauze Check the syringe and wipe the outer wall of the needle
Cotton swab Cleaning reagent&sample tray, etc.
Vacuum cleaner Cleaning fan, air filter, etc.
Brush Cleaning dust screen
Tweezers Disassemble needles, syringe gaskets, etc.
Syringe Needle for reagent&sample probe
Beaker Washing needle
Alcoholic Washing probe, stirrer, washing part, etc.
maintenance-6
maintenance
Dedicated screen keyboard

Clean touch screen and keyboard
cleaner
Fiber-free gloves Rinse the reaction cup, replace the reaction cup, etc.
13.2 Regular Maintenance

13.2.1 Introduction
Regular maintenance items are defined based on the condition of the various components of the
instrument and the actual use, and must be strictly performed by trained personnel in accordance
with the specified cycle to ensure instrument performance and reduce unnecessary service calls.
Be sure to familiarize yourself with the maintenance procedures in this section before performing
maintenance.
The items in the regular maintenance are carried out manually. Please carefully follow the steps in
this user manual for maintenance.
13.2.2 Maintenance cycle definition
[Maintenance List] The maintenance items on the interface are divided into seven cycles in the
maintenance cycle.
13.2.3 Maintenance Work

Maintenance requirements and content are different for different maintenance cycles. All
maintenance provided in this chapter is based on the complete configuration of the instrument. If
some modules are not selected, there is no need to perform the corresponding maintenance
operations.
Regular cleaning, inspection and regular parts replacement are required.
The parts that are regularly maintained, inspected, and replaced regularly are shown in Table 13-5
(calculated by using the instrument for 5 hours per day):
Table 13-5 Part replacement parts periodic table
Period
For 1
No Item For once
year 1 6
day timely weekly 3 month yearly
month month
1 Sample tray ●
2 Reagent&sample probe ○
Reagent&sample probe
3 cleaning tank ○
Stirrer cleaning tank
4 6 24
Cuvette (8/group) ○ ●
(note a) group group
Reaction tank and
5 reaction tank heating ○
belt
6 halogen lamp (light
6 1 2 ●
source lamp)
maintenance-7
maintenance
Period
For 1
No Item For once
year 1 6
day timely weekly 3 month yearly
month month
Washing part washing

7 ○
probe
8 Stirrer ○
Reagent&sample probe
9 ●
pump
10 Water supply filter ○
Reagent disk
11 ○
refrigeration unit
12 Cooling fan ○
Printing paper and

13
printer ribbon, ink, ●
(note c)
toner cartridge
14 Pure water device test ○ ●
15 Waste liquid discharge ○
(○:Regular cleaning and inspection ●Regular replace and adding)
Warning:
The table shows the maximum usage count.

The halogen lamp has a service life of 2000 hours. In order to ensure the
accuracy and precision of the test results, it is recommended to replace the
halogen lamp with more than 1500 hours.
The instrument can be equipped with an inkjet or laser printer, and the user
can select the printer consumable according to the printer.
The background save should be performed once a week, otherwise an alarm
with an abnormal cup blank value may occur.
If the conductivity of pure water exceeds 1 μs/cm, it is necessary to replace
the consumables of the pure water system.
Please perform the maintenance in strict accordance with the steps described in this chapter. If
calibration and QC tests are required after maintenance, be sure to perform.
13.3 Daily Maintenance

13.3.1 Check reagent&sample probe / stirrer / cleaning needle / cleaning tank
If the reagent&sample probe, cleaning needle, cleaning tank or stirrer is abnormal, it may affect
the test and result in inaccurate results. Therefore, before starting the test every day, check the
outside of the reagent&sample probe for dirt and crystals, whether the stirrer is rotating
abnormally, and whether the cleaning needle and the cleaning tank are in a normal status. If this is
the case, clean or adjust it immediately.
Purpose
Check whether the probe tip of the reagent&sample and the reagent&sample are dripping, whether
there is dirt on the outer wall and whether the water in the inner wall is normal. Check whether the
maintenance-8
maintenance
stirrer rotates normally. Check whether the water in the cleaning needle and the cleaning tank is
normal.
Maintenance opportunity
It is recommended to perform this maintenance operation before starting the test every day.
Instrument status
When performing this maintenance operation, make sure the instrument is in standby.
Precautions
Warning:
Be careful to avoid pinching or bending the reagent&sample probe, stirrer or

cleaning needle.

Operation Steps
1. Open the top cover of the analyzer.
2. Check the reagent&sample probe/stirrer/clean needle for any dirt on the outer wall. If there is
dirt, wipe the outer wall of the needle with a cotton swab dipped in alkaline cleaning solution, and
wipe the surface of the needle with a cotton swab with pure water, as shown in Figure 13-1:
a)reagent&sample tray b)stirrer c)washing probe

Figure 13-1 Wipe the outer wall of the probe
3. Connect the instrument online and perform three exhaust operations.
4. Observe the water discharge of the inner wall of each needle (as shown in the figure below). If
the wash water is sprayed or not discharged vertically from the needle tip, the needle may be
clogged. First, perform the clogging maintenance operation of the needle. Refer to ―13.8
Unscheduled Maintenance‖ and then check again. if it is still not normal, you need to perform
needle changing maintenance operation, or contact customer service engineer.
maintenance-9
maintenance
Figure 13-2 Normal and abnormal water flow direction of the needle
5. Observe whether the cleaning water out of the cleaning tank is normal, whether the water
volume is suitable, and whether the water flow in the cleaning tank can be washed up to about 5
mm above the needle tip. If the effluent is normal, proceed to the next step, otherwise contact
customer service engineer.
6. Click the ―Initialize‖ icon to observe whether the operation of each module is normal. If it is
normal, you can test it later. If the modules are not working properly, please contact customer
service engineers.
13.3.2 Check pure water connection

The connection of pure water is unnormal, which may result in insufficient water supply or water
leakage, which may result in continuous testing.
Purpose
Check the pure water connection to make sure the water supply is normal.
Instrument status
When performing this maintenance operation, make sure the instrument is in standby.
Operation steps
1. Check whether the water inlet on the rear panel of the analysis module is well connected to the
water supply pipeline.
2. Check that there is enough deionized water in the water tank or other external water storage
container.
3. Check that the catheter is unobstructed without distortion or leakage.
4. Check if the water module switch is turned on.
13.3.3 Check waste connection

If the waste liquid pipeline is improperly connected, or the high-concentration waste liquid tank is
full and is not emptied in time, it will cause the waste liquid to overflow, resulting in
environmental pollution and cross-infection, and even damage the instrument. Therefore, it is
often necessary to check the waste connection of the instrument.
Purpose
Check if the waste line connection and the high-concentration waste tank are not empty to avoid
waste overflow.
Maintenance
Instrument status
When performing this maintenance operation, make sure that the analysis unit is powered off or in
standby.
maintenance-10
maintenance
Precaution:
During maintenance work, be sure to wear gloves and work clothes to prevent
infection and wear protective glasses if necessary.
When disposing of waste liquid, dispose of high-concentration waste liquid in
accordance with local regulations.
Operation Procedures:
1. Check whether the waste liquid discharge system is normal, keep the waste liquid pipeline
unbending, discharge smoothly, and treat the high and low concentration waste liquid properly
(the waste liquid treatment method refers to local regulations).
2. Confirm that the waste liquid guiding tube is unblocked and not bent. Otherwise, the waste
liquid may overflow from the analysis module panel due to poor drainage, which may cause
damage to the analysis module.
3. If the liquid leakage still occurs after the above operation, please contact our customer service
department or the distributor in your area.
4. Emptying the waste liquid in the high-concentration waste liquid tank.
13.3.4 Reaction Cup Detection
After long-term use of the reaction cup, substances such as protein or debris may remain on the
inner surface and cannot be cleaned, which may affect the light transmittance of the reaction cup.
In addition, if the inner or outer wall of the reaction cup is contaminated or the reaction cup is
scratched or cracked. Both affect the transmittance or uniformity of the cuvette, which in turn
affects the accuracy and stability of the absorbance test results. Therefore, it is necessary to
confirm the use status of the cuvette.
Purpose
Check if the cuvette is contaminated and the transmittance is reduced to avoid affecting the test
results.
Maintenance time
It is recommended to perform this maintenance daily, after changing the cuvette or after
cleaning the cuvette.
Instrument status
Before performing this maintenance, make sure the system is powered on for more than 20
minutes and is in standby. Also confirm that the cuvette has been placed in all cups. If not, please
add a reaction cup.
Precaution:
Precaution:
In order to ensure the performance of the light source lamp, please handle or
replace it as soon as possible after the cuvette is judged to be a dirty cup.
After the replacement is completed, the cuvette detection function should be
performed again. Since the residual material in the reaction cup will affect the
reaction result of the reaction cup, it is recommended to perform the reaction
cup test after completing the ―cleaning background‖.
Operation Procedure:
Make sure light source has opened more than 20min, open —— check
showing status of cuvette. Check all cup positions, record the cup position information marked in
red, and perform [Cleaning Background] or [Replacement Cuvette] Maintenance. For details,
maintenance-11
maintenance
please refer to “13.3.4 Reaction Cup Detection” and “13.6.1 Replacing the Reaction Cup”. The
screen displays all the reaction cups and identifies the dirty cups by color:
White: free cuvette
Pink: add R1 already
Blue: add R1 and sample already
Purple: add R1, R2 and sample already
Green: finished inspection
Red: dirty
13.4 Weekly Maintenance

13.4.1 Cleaning reagent&sample probe / cleaning needle / stirrer outer wall
Reagent&sample probe, cleaning needle, stirrer outer wall is easily soiled, which may cause
cross-contamination between samples or reagents, and may not obtain correct test results. It is
recommended to clean the outer walls of the reagent&sample probe, the cleaning needle and the
stirrer every week.
Purpose
Clean reagent&sample probe, cleaning needle and outer wall of stirrer, to avoid acrossing
pollution.
Maintenance time
Suggest proceed maintenance weekly.
Maintenance tool
Cotton swab (several), alkaline cleaning solution, pure water
Instrument Status
When proceed maintenance, please ensure machine is off or in standby.
Precautions:
Warnings:
Be careful to avoid scratching your hand with the tip of the needle. Prevent
bending or scratching of the reagent&sample probe and reagent&sample
probe. If the above situation occurs, the reagent&sample probe or the
reagent&sample probe should be replaced immediately, otherwise the test
result will not be guaranteed.

Operation procedure:
1. Open the top cover of chemistry analyzer.
2. Manually rotate the probe rocker arm to be maintained to a convenient maintenance position.
Gently wipe the outer wall of the probe with a cotton swab dipped in alkaline cleaning solution.
Pay particular attention to the tip of the probe until the surface of the probe is smooth and free of
dirt.
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maintenance
Figure13-3 Rotating Sample arm
Warning:
Do not hold the probe at the top of the probe cover by hand. The wrong
operation is shown below.
Figure13-4 Rotating Sample arm

3.Wipe off the alkaline cleaning solution on the probe with a cotton swab with pure water.
When wiping, do not push and pull horizontally to avoid bending the needle bar and affect the
normal test.
a)Sample probe b) Stirrer c) Cleaning needle

Figure 13-5 Outer door of wiping probe
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maintenance
13.5 Monthly maintenance

13.5.1 Cleaning tank
After long-term use of the instrument, waste liquid and dust can easily accumulate in the cleaning
tank, thereby blocking the cleaning tank. It is recommended to clean the cleaning tank every
month to ensure clean and smooth.
Purpose
Remove waste liquid and dust from the two cleaning tanks (reagent&sample probe, stirrer) to
prevent clogging.
It is recommended to perform this maintenance operation monthly.
Maintenance supplies
Cotton swab, alkaline cleaning solution
Instrument status
When performing this maintenance operation, make sure the instrument is idle.
Precautions
During maintenance work, be sure to wear gloves, work clothes to
prevent infection, and wear protective glasses if necessary.
Steps
1. Open the top cover of the analyzer.
2. Manually remove the reagent&sample probe and stirrer cross arm so that the
reagent&sample probe and the stirrer leave the cleaning tank.
warning
Do not hold the needle at the top of the needle cover by hand. The wrong
operation is shown below.
Figure 13-6 Rotating the sample arm

3. Clean the inside and the periphery of the cleaning tank with a clean cotton swab with an
alkaline cleaning solution, and then wipe off the residual alkaline cleaning solution with a clean
cotton swab.
maintenance-14
maintenance
Figure 13-7
4. Then, about 100 mL of pure water is injected into each of the washing tanks for rinsing.
5. The system performs the cleaning operation of the outer wall of the needle.
6. Observe whether the water in the cleaning pool is normal, that is, whether the cleaning pool can
reach about 5mm above the needle tip. if it is not normal, please contact the customer service
engineer.
13.6 Maintenance every three months

13.6.1 Replacing the cuvette
After long-term use of the reaction cup, substances such as protein or debris may remain on
the inner surface and cannot be cleaned, which may affect the light transmittance of the reaction
cup. In addition, if the inner or outer wall of the reaction cup is contaminated or the reaction cup is
scratched or cracked. Both affect the transmittance or uniformity of the cuvette, which in turn
affects the accuracy and stability of the absorbance test results. Generally, after three months of
continuous use (calculated by 5 hours per day), it is recommended to replace the cuvette in order
not to affect the accuracy of the measurement results and the detection speed.Or software in
the case that the dirty cup status of the reaction tray reaches 1/3 or more, the new reaction cup
needs to be replaced.
Purpose
Replace the cuvette to ensure the accuracy of the results.
This maintenance is recommended every three months.
Reaction cups (8/group)*6 groups.
Instrument status
Make sure the analyzer is powered off during this maintenance.
Precautions:

Steps
1. Turn off the main power switch of the instrument and remove the reaction disk cover.
2. Unscrew the fastening screw, as shown in Figure 9-32
maintenance-15
maintenance
Figure 13-8
3. Remove the six sets of reaction cups, as shown in Figure 13-9:
Figure13-9
1. Install six new cuvettes on the reaction tray in reverse order.
2.
Warning:
 If the used cuvette is exposed to the air for a long time, the
contaminants may condense on the wall of the cup. Therefore, the
reaction tray cover should be covered in time. In addition, if an
emergency stop occurs during the test, the cuvette that has not been
cleaned should be cleaned or rinsed with pure water to prevent the
reaction solution from remaining on the cuvette for a long time.
 Never use organic solvents (benzenes, alcohols, etc.) to scrub or soak the
cuvette.
13.6.2 Cleaning of the reaction tank
The reaction tank should be cleaned in time for long-term use to prevent dust and other factors
from affecting the test results. In addition, especially in the case of water intake, it should be
wiped clean in time to prevent contamination of the reaction cup and light path, affecting the test
results.
Purpose
Clean the reaction tank to prevent dust and other effects from affecting the test results
This maintenance is recommended every three months.
Gauze, pure water.
Instrument status
maintenance-16
maintenance
Precautions:
Steps
2. Unscrew the fastening screw, as shown in Figure 13-8 above.
3. Remove the six sets of reaction cups and place them in pure water or clean place, as shown
in Figure 13-9 above.
4. Wipe the reaction cell with a clean, wet gauze (be careful not to wipe the metering
window), as shown in Figure 13-10:
Figure 13-10 Wipe the reaction tray
After the reaction tank is cleaned, install the reaction cup and cover the reaction tray cover.
13.7 Maintenance every six months

13.7.1 Replacing the light source
After the light source lamp is aged, the light energy deviates from the measurement range of the
light amount. After the service life is more than 2000 hours, when the sample is tested, it will not
be tested correctly due to the interference. After the “Instrument Detection” interface is not
blocked by the AD gain, when the AD value does not reach the gain value of 20000 multiple times,
the halogen lamp should be replaced.
When the halogen lamp reaches the end of its service life, after entering the main interface of the
software, it will prompt “Halogen lamp life to limit” alarm.
Click on the red alarm button ,The alarm message window is displayed as shown in Figure
13-11. The halogen lamp should be replaced.
maintenance-17
maintenance
Figure 13-11
Purpose
Replace the light source to ensure the accuracy of the test results
This maintenance is recommended every six months.
Halogen lamp, gauze, pure water, alcohol, cross flower screwdriver.
Instrument status
Steps
1. Prepare a new halogen lamp, as shown in Figure 13-12:
Figure13-12
Warning
Do not touch the surface of the halogen lamp, otherwise it will affect the
amount of light. If the surface is found to have smudges such as
fingerprints, wipe it with a gauze dampened with alcohol.
2. Turn off the main power switch of the instrument. After about 30 minutes (to completely cool
the lamp chamber), proceed to the next step to avoid burns.
3. Use a cross-blade screwdriver to unscrew a screw on the panel 1.
maintenance-18
maintenance
Panel 1
Figure 13-14 Unscrew the screw

4, after removing the panel, as shown
Halogen lamp holder
Terminal
block
Fastening screw
Figure 13-15 Remove the panel 1

5. Remove the protective cover on the terminal block, use a cross-blade screwdriver to
unscrew the two fixed terminals of the halogen lamp lead, remove the white silicone lead
wire, and cut the cable tie with a diagonal port to facilitate the replacement of the halogen
lamp. -16.
Wire 1
Wire 2
Tie
Figure13-16 Remove the halogen lamp

5. Unscrew the fastening screw and remove the halogen lamp, as shown in Figure 13-17.
maintenance-19
maintenance
Locating pin Fastening screw
Figure 13-17 Removing the fastening screw

7. Replace the new halogen lamp with the reverse steps above, and note that the screws are
tightened. The leads should not be loose or lifted.
8. Turn on the power of the instrument and initialize the instrument. After the instrument is in
standby, check that the spot meets the size of 5mm. Then, the gain of the AD reading is not
blocked in the “Instrument Detection” interface. When the value is higher than 40000, the test
can be performed.
Warning:
The protective cover on the terminal block must be installed to prevent

shorting of the line on the terminal block.
13.8 Unscheduled maintenance

13.8.1 Cleaning the instrument panel
The analyzer and the operation department often touch the place, it is very easy to get dirty. In
order to keep the working environment clean and reduce the biological risk, the exposed parts
such as the analyzer table and the cover should be cleaned at the right time.
Purpose
Clean the analysis module table top, the cover, remove dust or other dirt, and keep it clean.
Perform this maintenance when there is dust or other dirt on the countertop that contaminates the
countertop.
Clean gauze, neutral detergent, pure water
Instrument status
When performing this maintenance operation, make sure the instrument is in a non-test status.
Precautions
Warning:
Do not spill liquid on the analyzer to prevent liquid from immersing and
causing damage to the instrument.

 During maintenance work, be sure to wear gloves and work clothes to
prevent infection and wear protective glasses if necessary.
 Do not discard the gauze used for wiping. Please dispose of it in
accordance with relevant regulations.
maintenance-20
maintenance
Steps
1. Confirm that the instrument is in a non-test status and open the upper cover of the
analysis module.
2. Gently wipe the sub-module table top and the disc cover with a gauze dipped in alcohol.
3. Use a special cleaning agent to clean the keyboard and other parts.
4. Cover the upper cover of the analysis module.
13.8.2 Cleaning reagent&sample tray
When the sample or reagent is accidentally spilled into the pan, or when visually inspecting the
inner wall of the bin for dust and condensed water during the cooling process, it should be cleaned
in time to reduce the risk of cross-contamination.
Purpose
Clean the reagent&sample tray assembly to keep the working environment and the table clean and
tidy, reducing the risk of cross-contamination.
Perform this maintenance when a sample or reagent accidentally spills into the chamber and there
is dust on the inside of the visual chamber and condensation occurs during cooling.
Clean gauze, pure water, alcohol, cotton swab
Instrument status
When performing this maintenance operation, make sure the instrument is in a standstill or
standby status.
Precautions
Warning
Do not spill water or alcohol into the reagent&sample compartment to

avoid damage to the instrument.

Steps
1. Confirm that the instrument is in the stop or standby status.
2. Open the reagent&sample tray cover, unscrew the reagent&sample tray handle
counterclockwise, and take the reagent&sample tray and place it in a safe and reliable
position.
Reagent&sample tray handle
Figure 13-18 Removing the reagent&sample tray handle
maintenance-21
maintenance
3. Wipe the inner wall of the tray with gauze with a small amount of deionized water or alcohol. If
necessary, use a gauze with a small amount of neutral detergent to wipe.
4. Use gauze, a small amount of deionized water or alcohol to wipe the reagent&sample tray. For
dirt on the sample and reagent positions, use a cotton swab dipped in a small amount of alcohol.
5. Wipe the condensate from the reagent&sample tray to the condensate drain.
Condensate drain
Figure 13-19 Wiping off the condensate

Put the reagent&sample tray back into the warehouse and cover the disc cover.
13.8.3 Cleaning the reagent&sample probe inner wall
If the reagent&sample is clogged, the reagent&sample probe will not be loaded according to the
normal test procedure and the test cannot be performed. When the reagent&sample probe is found
to be blocked, the sample suction operation cannot be performed, or the reagent&sample probe is
inspected, and the inner wall of the reagent&sample probe is found to be abnormal, the inner wall
of the reagent&sample probe should be cleaned in time.
Purpose
Clean the inner wall of the reagent&sample probe to avoid the test cannot be performed properly
due to clogging.
Perform this maintenance when the reagent&sample probe is clogged, the aspirate operation
cannot be performed, or the reagent&sample probe is checked to find that the water in the inner
wall of the reagent&sample probe is abnormal.
Needle tool, small flat screwdriver, small Phillips screwdriver, beaker, pure water, screw syringe
Instrument status
When performing this maintenance operation, make sure the instrument is in an idle or faulty
status.
Precautions
Steps
1. Turn off the power of the analysis module and open the cover of the analysis module.
2. Hold the probe cover gently with one hand, pry the probe cover to one side, then loosen the
other side, then lift the probe cover and lift it off, as shown in Figure 13-20.
maintenance-22
maintenance
Figure 13-20 Removing the probe cover

3. Pull off the liquid level signal line, you need one hand to hold the cross arm from below, the
other hand pinch the 2P terminal, unplug the liquid level signal line, be careful not to pull the
liquid level signal line to prevent the terminal from falling off, such as Figure 13-21 shows.
Figure 13-21 Unplugging the liquid level signal line

4. Place a cotton absorbing cloth on the level plate to prevent water droplets from falling on the
level plate when the pipe is unplugged, as shown in Figure 13-22.
maintenance-23
maintenance
Figure13-22
5. Unplug the tubing at the end of the reagent&sample, as shown in Figure 13-23.
Figure 13-23 Unplugging the pipe

6. Insert the probe from the lower end of the probe. Place the cotton cloth on the side of the
level plate and clean it with a needle (0.3mm), as shown in Figure 13-24.
Figure 13-24 Cleaning reagent&sample probe

7. After cleaning the probe with a needle (0.3mm), lift the needle from the light blocking plate to
one side of the sample arm, and at the same time, align the needle tip with the cleaning tank, and
then extract 10mL of pure water with a syringe. Pure water was injected into the probe from the
upper end of the probe, and the reagent&sample probe was repeatedly washed 10 times using a
syringe.
If the syringe piston leaks during the syringe push, the needle tool cannot clear the
reagent&sample probe, the reagent&sample probe is severely blocked, and a new probe needs to
be replaced. As shown in Figure 13-25.
maintenance-24
maintenance
Figure 13-25 Water injection

8. When the inner wall of the reagent&sample probe flows out from the tip of the probe and 10
mL of pure water is completely discharged, and the water flow is smooth, the inner wall of the
reagent&sample probe is cleaned successfully.
9. Put the probe back into the light-blocking piece, and re-connect the liquid path system, screw it
to the probe insertion liquid pipe about 1cm. at the same time check whether the spring can be
freely stretched.
If the spring can flex freely, go to the next step.
If not, check if the spring is stuck and troubleshoot.
10. Insert the plug connected to the tail of the reagent&sample into the connector socket of the
liquid level detecting circuit board.
11. After the maintenance operation is completed, turn on the power of the analysis module and
observe whether the LED green light of the number D2 on the circuit board on the probe rocker is
lit.
If it is lit, it indicates that the liquid level detection system is normal.
If it is not normal, please contact the company's customer service department or the distributor
in your area.
12. Install the cross arm cover until you hear the click of the card, and confirm that the installation
is in place.
13. Hold the reagent&sample probe close to the cross arm by hand, gently push the
reagent&sample probe vertically upwards, and then lower it to check whether the spring inside the
cross arm can freely expand and contract.
If the spring does not expand and contract freely, install the cross arm cover improperly,
reinstall the cross arm cover, and confirm that the spring is free to move.
14. Turn on the instrument's main power switch and initialize the instrument.
15. Click “Maintenance” in the menu bar to open the “Instrument Detection” form and find
the sample arm in the list of test items, as shown in Figure 13-26.
Figure 13-26 Sample arm

16. Sample level check: Click the sample position “Y”, the reagent&sample probe is placed on
the left side. When the reagent&sample probe stops above the sample position of the
reagent&sample tray, check whether the probe tip of the reagent&sample probe is at the center of
the sample cup. As shown in Figure 13-27, then click the zero position "Y" and the
reagent&sample probe swings back to the initial position.
Sample cup
The front end of
dispensing probe
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maintenance
Figure 13-27 Checking the position

Note: If the probe tip of the reagent&sample probe is not at the center of the sample cup, please
contact customer service engineer.
17. Reagent outer ring level check: Click the reagent outer ring “Y”, the reagent&sample probe is
placed on the left side. When the reagent&sample probe stops above the reagent&sample disk
outer ring, check whether the reagent&sample probe tip is outside the reagent. Circle the center of
the reagent position, then click the zero position "Y" and the reagent&sample probe swings back
to the initial position.
Note: If the tip of the reagent&sample probe is not at the center of the reagent outer ring reagent
bottle, please contact customer service engineer.
18, the reaction cup level check: click the reaction cup "Y", the reagent&sample probe is placed
right, when the reagent&sample probe stops above the reaction tray reaction cup, check whether
the probe tip of the reagent&sample probe is at the center of the reaction cup Position, as shown in
Figure 13-28, then click on the zero position "Y" and the reagent&sample probe swings back to
the initial position.
反应杯
Cuvettes
The front end of

针的前端
dispensing probe
Figure13-28
Note: If the probe tip of the reagent&sample probe is not at the center of the reaction cup, please
19. Sample position vertical position check: Click sample position “Y”, the reagent&sample
probe is left to stop above the sample position, click the vertical position “Y”, the
reagent&sample probe will drop until the tip of the sample just touches the bottom of the sample
cup. , then click the vertical position "Y", lift the reagent&sample probe up to the top of the
sample position, then click the zero position "Y", and the reagent&sample probe swings back to
the initial position.
20, reagent outer ring vertical position check: click the reagent outer ring "Y", the reagent&sample
probe is left to stop above the reagent outer ring, click the vertical position "Y", the
reagent&sample probe will always drop until the probe tip just touches the reagent Click the
vertical position "Y" at the bottom of the cup, lift the reagent&sample probe over the outer
circumference of the reagent, and then click the zero position "Y", and the reagent&sample probe
swings back to the initial position.
21, the vertical position of the reaction cup: click the reaction cup "Y", the reagent&sample probe
is placed right to the top of the reaction cup to stop, click the vertical position "Y", the
reagent&sample probe will drop, so that the Teflon layer is coated Partially all enter the cuvette,
click the vertical position "Y", the reagent&sample probe is lifted above the cuvette, then click the
zero position "Y", and the reagent&sample probe swings back to the initial position.
13.8.4 Replacing the reagent&sample probe
maintenance-26
maintenance
If the reagent&sample probe is damaged or scrapped, it cannot be repaired. or it is severely

blocked and cannot be unblocked. or if it is bent and scrapped, it should be replaced in time to
avoid affecting the test.
Purpose
Replace the reagent&sample probe.
The reagent&sample probe is damaged and scrapped, and this maintenance is performed when the
repair cannot be performed. For example, if the reagent&sample probe is severely blocked, it
cannot be unblocked, or the reagent&sample probe is bent and scrapped.
Flat-blade screwdriver, Phillips screwdriver, new reagent&sample probe
Instrument status
status.
Precautions
Warning
Be careful to avoid being scratched by the tip of the probe.

Steps
1. Prepare a new reagent&sample probe to be replaced.
2. Turn off the power of the analyzer and open the top cover of the analyzer.
3. Remove the cross arm cover from the cross arm seat.
4. Hold the board with one hand and unplug the connector from the other hand.
5. After removing the transparent heat shrinkable tube of the reagent&sample probe near the
cross arm, remove the fastening screw on the reagent&sample probe and keep it in a safe
place to prevent loss.
6. Hold the connector on the reagent&sample probe with one hand and hold the connector of
the liquid path tube with the other hand and turn it counterclockwise until the liquid path
The pipe joint is pulled out, and the liquid pipe is gently pulled out from the reagent&sample
probe by hand.
7. Slowly remove the reagent&sample probe from the cross arm.
8. Insert a new reagent&sample probe from the top and bottom into the pinhole on the cross
arm of the reagent&sample probe, and align the hole on the cross section of the
reagent&sample probe with the photoelectric block in the transverse arm cavity.
9. Align the liquid pipe joint with the reagent&sample probe joint and screw it clockwise to 1
cm deep.
10. Insert the plug connected to the tail of the reagent&sample into the connector socket of
the liquid level detecting circuit board.
11. Screw on the screw compression spring.
12. Pinch the reagent&sample probe near the rocker arm with your finger, push the
reagent&sample probe vertically upwards, and then lower it to check whether the spring can be
freely stretched.
maintenance-27
maintenance
If not, check if the spring is stuck, or if the screw is pressed too tightly to correct the problem.
13. After the maintenance operation is completed, turn on the power of the analyzer and observe
whether the LED green light of the number D2 on the circuit board on the cross arm of the probe
is lit.
If it is lit, it indicates that the liquid level detection system is normal.
If it is not normal, please contact the company's customer service department or the distributor
in your area.
14. Install the cross arm cover until you hear the click of the card, confirm that the installation is
in place.
15. Turn on the main power switch of the instrument and initialize the instrument.
16. Click “Maintenance” in the menu bar to open the “Instrument Detection” form and find
the sample arm in the test item list, as shown in Figure 13-29.
Figure 13-29 Sample arm

17. Sample position level check: Click the sample position “Y”, the reagent&sample probe is
placed on the left side. When the reagent&sample probe stops above the sample position of the
reagent&sample tray, check whether the probe tip of the reagent&sample probe is at the center of
the sample cup. As shown in Figure 13-30, then click the zero position "Y" and the
reagent&sample probe swings back to the initial position.
样本杯
针的前端
Figure 13-30 Checking the position

Note: If the probe tip of the reagent&sample probe is not at the center of the sample cup, please
18, reagent outer ring horizontal position check: click the reagent outer ring "Y", the
reagent&sample probe is placed on the left side, when the reagent&sample probe stops above the
outer ring of the reagent&sample tray reagent, check whether the probe tip of the reagent&sample
probe is outside the reagent Circle the center of the reagent position, then click the zero position
"Y" and the reagent&sample probe swings back to the initial position.
Note: If the tip of the reagent&sample probe is not at the center of the reagent outer ring reagent
bottle, please contact customer service engineer.
19. Check the level of the reaction cup: click the reaction cup “Y”, the reagent&sample probe is
placed on the right side. When the reagent&sample probe stops above the reaction cup reaction
cup, check whether the probe tip of the reagent&sample probe is at the center of the reaction cup.
maintenance-28
maintenance
Position, as shown in Figure 13-31, then click the zero position "Y", the reagent&sample probe
Figure 13-31
Note: If the probe tip of the reagent&sample probe is not at the center of the reaction cup, please
20, sample position vertical position check: click the sample position "Y", the reagent&sample
probe is placed to the left of the sample position to stop, click the vertical position "Y", the
reagent&sample probe will continue to drop until the tip of the probe just touches the bottom of
the sample cup. , then click the vertical position "Y", lift the reagent&sample probe up to the top
of the sample position, then click the zero position "Y", and the reagent&sample probe swings
back to the initial position.
21, reagent outer ring vertical position check: click the reagent outer ring "Y", the reagent&sample
probe is left to stop above the reagent outer ring, click the vertical position "Y", the
reagent&sample probe will always drop until the probe tip just touches the reagent Click the
vertical position "Y" at the bottom of the cup, lift the reagent&sample probe over the outer
circumference of the reagent, and then click the zero position "Y", and the reagent&sample probe
22, the vertical position of the reaction cup: click the reaction cup "Y", the reagent&sample probe
is placed right to the top of the reaction cup to stop, click the vertical position "Y", the
reagent&sample probe will drop, so that the Teflon layer is coated Partially all enter the cuvette,
click the vertical position "Y", the reagent&sample probe is lifted above the cuvette, then click the
zero position "Y", and the reagent&sample probe swings back to the initial position.
13.8.5 Replacing the stirrer
If the stirrer is damaged or scrapped, it cannot be repaired. or if it is bent and scrapped, it should
be replaced in time to avoid affecting the test.
Purpose
Replace the stirrer.
Perform the maintenance when the stirrer is damaged and scrapped and cannot be repaired.
Alkaline cleaning solution, pure water, clean gauze, new stirrer, Phillips screwdriver
Instrument status
status.
Precautions
Warning
Be careful to avoid being scratched by the tip of the stirrer.
maintenance-29
maintenance

Steps
5、 1. Prepare a new reagent&sample probe to be replaced,
6、 2. Turn off the power of the analyzer and open the top cover of the analyzer.
7、 3 Remove the reaction tray cover.
8、 5. Rotate the stirring arm to the direction of the reaction tank by hand (the method is like
the sample arm operation), as shown in Figure 13-32:
Figure 13-32 Rotating mixing arm

5. Use a Phillips screwdriver to loosen the two fastening screws for one week. The method is
shown in Figure 13-33.
Figure 13-33 Loosen the screws

6. Wipe the tip of the new stirrer with a cotton swab dipped in alkaline cleaning solution, and then
wipe the surface of the stirrer with a cotton cloth dampened with pure water (do not bend the
stirrer when wiping).
7. When installing the new stirrer, insert the stirrer into the root of the motor shaft and fix it with
the M2 screw, as shown in Figure 13-34.
maintenance-30
maintenance
Mixing arm
M2 screw Stirrer
Figure 13-34 Installing the stirrer
Note: The stirrer pin must be securely secured to prevent instrument malfunction.
8. Lift the stirring arm to the top and rotate the stirring arm in the direction of the reaction cup by
hand. The distance between the agitating stirrer and the cuvette is approximately 1.3 cm.
9. Turn on the instrument power switch and initialize the instrument. /0, in the menu bar
"Maintenance", open the "Instrument Detection" form, find the mixing arm, as shown below, click
the reaction cup "Y", check the level of the reaction cup of the stirrer, confirm whether the
position of the stirrer is Located in the center of the reaction cup, if you click the zero position
“Y” in the center, the stirrer can swing back to the top of the cleaning tank.
Figure 13-35 Mixing arm inspection

Look at the position of the stirrer relative to the cuvette in a top view, as shown in Figure 13-36:
Stirrer
Cuvettes
Figure 13-36
Note: If you are not in the center of the cuvette, please contact the customer service engineer.
11. Vertical position of the stirrer: In the “Instrument Detection” form, click the reaction cup
“Y”, the stirrer is placed to the left of the reaction cup, then click the vertical position “Y”, the
stirrer is lowered, and then click Vertical position "Y", the stirrer is lifted, and finally click the
zero position "Y", the stirrer can swing back to the top of the cleaning tank.
13.8.6 Replacing the Reaction Cup
When the cuvette is contaminated with stains such as serum or debris, scratches or cracks, it
will affect the accuracy of the test absorbance. Therefore, it is necessary to test the reaction cup. If
the cup is found to be abnormal, it should be replaced in time.
Purpose
Make sure the cuvette is normal, free from contamination, scratches or cracks.
maintenance-31
maintenance
Replacement of the cuvette is an occasional maintenance. Replace it in time when:
After performing the reaction cup test, the cup was found to be abnormal.
After performing the cuvette flushing operation, the cuvette is still unusable.
I found that the light passing surface of the reaction cup was scratched or broken.
Fiber-free gloves, dry dust-free fiber cloth or gauze, spare reaction cup
Instrument status
Precautions:
Steps
2. Unscrew the fastening screw, as shown in Figure 13-37.
Figure 13-37
3. Use the index finger and thumb to remove the reaction cup of the corresponding cup along the
reaction disk, and find the corresponding cup according to the cup number silk screen.
Bit
4. Put the supplied reaction cup or cleaned reaction cup into the reaction tray and press it to the
bottom of the cup.
stop.
5. Put the corresponding joint into the corresponding position of the reaction tray and tighten the
fixing screws.
Warning
 When installing the reaction cup, be careful not to scratch the reaction
cup. Do not touch the middle and lower parts of the light-passing surface
of the reaction cup. Otherwise, the light-passing surface will be
contaminated, which will result in inaccurate absorbance data.
 When installing the cuvette, ensure that the light passing surface of the
reaction cup is placed along the radial direction of the reaction disk.
 Always use gloves without fibers and powders during operation to
ensure that the clear side of the cuvette is not contaminated.
maintenance-32
maintenance
14 Alarm and fault handling
This chapter describes how to view the fault log and how to determine the source and solution of
the fault in the event of a failure. Read this chapter carefully and master the fault identification
method to help you better use the instrument.
maintenance-33
Alarm and fault handling
14.1 Troubleshooting Methods
14.1.1 Introduction
When the instrument fails, it will be manifested in various ways. The following sections describe
troubleshooting methods to guide you through troubleshooting and troubleshooting when you find
an instrument failure.
In general, troubleshooting requires the following steps:
.
instrument.
.
implement solutions and implement effective solutions.
14.1.2 Observing instrument failure prompt

Instrument failures may involve hardware, software, and complete machines. When a fault occurs,
it is represented by various prompting methods to help you identify the source of the fault, the
cause and the solution. These prompting methods include an alarm tone prompt, an alarm message
displayed in the alarm bar, a color identification, a pop-up alarm box, a result flag, and a fault log.
Through these prompting methods, you can get detailed information about the instrument failure,
and then find the corresponding solution.
Alarm tone
When the instrument fails, the alarm buzzer will sound an alarm tone, prompting you to pay
attention and take the corresponding solution.
Displayed in the alarm prompt bar
When a prompt is generated, the latest fault alarm information is displayed in the alarm prompt
bar below the main interface.
After the alarm message appears, click the [Alarm] button to view the fault log. Analyze the cause
of the failure and take the appropriate solution.
Result tag
Also known as data alarms, the system will identify the calibration or sample test results as a
result of calibration errors or failures and result errors due to sample, reagent or system failure.
Fault log
All fault alarms will be logged in the fault log. By viewing the fault log, you can grasp the current
status of the instrument and facilitate troubleshooting.
14.1.3 Identifying Instrument Faults
After observing the instrument fault prompt and viewing the log and instrument status, you can
identify the instrument's fault and find the corresponding solution.
The following table lists the abnormal categories of the instrument. Please determine the solution
according to different categories:
Table 14-1 Instrument Fault Category
Some instrument faults that are displayed in the
alarm message prompts involve the various
subsystems of the instrument and are processed
Instrument in different ways. This type of fault is included
failure and error
in the “Fault Information Table”, and a detailed
description of the fault, its cause, and a solution
are found by the fault code.
A data alarm is a marker of the abnormal result
Data alarm
of a biochemical test and is included in the data
Alarm and fault handling-34

alarm table. The detailed description, cause and

solution of the alarm are found in the "Data
Alarms" list.
14.2 Instrument Faults and Handling

The fault of the instrument can be divided into faults according to different problems.
The failure analysis and solution for not showing the alarm prompt are shown in the
following table:
Table 14-2 Instrument Failure Analysis Table
accident details main reason Solution
The reagent&sample tip is dirty. Wipe the probe with a cotton swab
Reagent&sample tip The pipe or filler of the dipped in an alkaline cleaning solution.
with water droplets sampling and filling mechanism Perform maintenance checks.
has leakage or full bubble
Check the interface area and vent the
The cleaning mechanism line water pipe.
Water drops on the leaks or is completely bubbled. Perform maintenance on the cleaning
cleaning needle The nozzle and pipeline are mechanism. If you need to replace the
blocked. hose, please contact customer service
engineer.
1. Carry out maintenance of the cleaning
No water flowing out 1. The nozzle and pipeline are mechanism. If you want to replace the
of the cleaning nozzle blocked. hose, please contact customer service
engineer.
1. Carry out maintenance of the cleaning
1. The nozzle of the cleaning
Water overflow in the mechanism. If you want to replace the
mechanism and the pipeline are
cuvette hose, please contact customer service
blocked.
engineer.
1. The interface part is not 1. Confirm the leak and reinstall it.
Syringe pump leakage properly installed. 2. Replace the syringe pump.
2. Water leakage in the pump.
Confirm that the air enters and reinstall.
Perform exhaust in the system
1. The interface part is not
maintenance. If there are tiny bubbles
There are bubbles in properly installed.
that cannot be removed, you can gently
the syringe pump 2. The filling device is not fully
tap the syringe pump while the reagent
exhausted.
or washing water is flowing, and use
vibration to eliminate it.
1. Poor contact of the level plate
Check if the level plate interface line is
interface.
in good contact.
Abnormal liquid level 2. There is a problem with the
Check if the grounding is connected.
detection instrument grounding.
Check for large electromagnetic
3. There is a large
interference around.
electromagnetic interference.

Confirm that the reagents are prepared

and placed in the correct position.
Check for impurities in the sample.
The absorbance of the reaction Check the reaction tank for water or
Absorbance exceeds
solution exceeded the range of 0 impurities.
upper or lower limit
to 3.3 Abs. Inspect the cuvette for cracks and
scratches.
Check that the optical window is clean
or ingress.
The sample and reagent&sample probes
Stop the test after the have an anti-collision function. When
instrument is a striker occurs. the probe is hit, the machine needs to be
abnormally cleaned restarted. After the position check is
adjusted, the test is restarted.
Confirm that there are no foreign objects
1. The reaction tray cannot find at the code teeth and photoelectric
Reaction tray the stop position. switches below the reaction disk.
abnormality 2. The reaction tray does not Check if the photoelectric switch and
stop at the specified position. motor wiring are disconnected or
abnormal contact.
Check if the photoelectric switch cover
1. The movement in the left and is abnormal.
Reagent&sample
right direction is abnormal. Check if the corresponding photoelectric
probe position
2. The movement in the up and switch and motor wiring are abnormal.
abnormality
down direction is abnormal. Check if there is any abnormality in the
corresponding drive board installation.
Check if there is any abnormality
between the heater wire and the circuit
board wiring.
Abnormal reaction 1. The temperature of the
Check if the temperature control probe is
tray temperature reaction disk is abnormal.
installed properly.
The temperature is adjusted by software.
Observe how the board works.
1. Confirm that there is no abnormality
in the optocoupler on the lower side of
the reagent&sample tray.
1. The reagent&sample tray is 2. Check if the optocoupler and motor
abnormally moved. wiring are off or abnormal.
Reagent&sample tray
2. The reagent&sample disk 3. The reagent&sample tray is loose.
abnormality
does not stop at zero when it is 4. The calibration position of the
initialized. reagent&sample tray is unreasonable,
and the zero position should be within
90 degrees of the reagent&sample probe
level.

1. The instrument is not 1. Regularly maintain the instrument in

properly maintained on a regular accordance with the user manual.
basis. 2. Replace the new reagent and properly
2. The reagents deteriorate and store and use the reagent.
there are chemical substances or 3. The conductivity of pure water should
impurities. be below 1μs/cm.
3. The quality of pure water is 4. Wash the reaction cup thoroughly
poor. with the cleaning solution.
Poor repeatability
4, cleaning is not complete. 5, replace the reagent
5, the reagent crystallizes 6. Place reagents that may be
6. Analyze cross-contamination cross-contaminated or use a
between projects. cross-contamination procedure to avoid
7. The sample is unqualified them.
(fibrin in the sample). 7. Centrifuge the unqualified sample
8. There is a large again.
electromagnetic interference. 8. Remove the interference source.
The calibrator is used immediately after
The calibrator is concentrated or
it is added to the sample cup and stored
Poor accuracy ineffective.
correctly.
Poor analysis condition setting.
Set the parameters correctly.
No response after the Poor contact of the power plug Detect the power input part wiring
instrument is turned Instrument fuse burned out Replace the fuse and check the line
on
The instrument failure analysis and solution for generating alarm prompts are shown in the
following table:
Table 14-3 Instrument Failure Analysis Table for Alarms
Alarm Alarm
description Handling suggestions
number source
Press the shortcut key [Ctrl]+[F3] to reset
The sample tray did
Sample the instrument and try again. If the problem
512 not move to the
tray persists, please contact the customer service
specified position.
engineer.
Sample Press the shortcut key [Ctrl]+[F3] to reset
1290 Not down.
arm the instrument.
Reagent& The reagent&sample
1803 sample probe is not enough, Make up the sample size and retest.
probe position [{0}].
Unable to receive
AD absorbance data from
2059 Please contact customer service engineer.
module the data acquisition
module.
The interrupt of the
AD
2060 data acquisition Please contact customer service engineer.
module
module is abnormal.
Net water The water bucket is Add enough clean water to the outside of
2304
bucket insufficient. the instrument.
Alarm Alarm
number source
Insufficient water
outside the instrument
Net water Add enough clean water to the outside of
2305 results in insufficient
bucket the instrument.
water in the clean
water tank.
Net water The water bucket is
2306 Suspend the water purifier.
bucket too full.
Send data timeout to
3335 system Please link with the LIS is normal.
LIS serial port.
The water gap is not
Reaction up to standard and the
3584 Clean the cuvette.
tray reaction cup may have
dirt.
Abnormal The bulb energy is Check the lamp and retest. If it still alarms,
4097
lamp abnormal. please contact the maintenance staff.
Data
collection
Did not receive the
4098 communic It is recommended to check the line.
maximum cup number.
ation is
abnormal
Data
collection
The OD module does
4099 communic It is recommended to check the line.
not adjust the gain.
ation is
abnormal
Instrument Start test signal Check the sample and reagent balance and
4353
failure timeout. re-run after reset.
Instrument The reaction disk stop
4354 It is recommended to re-run after reset.
failure signal 1 times out.
Instrument The cleaning arm
failure action timed out.
Instrument
4358 Timer 1 timed out. It is recommended to re-run after reset.
failure
Instrument The reaction disk stop
failure signal 2 times out.
Instrument The sample arm action Check the sample and reagent balance and
4360
failure timed out. re-run after reset.
Instrument The stirring arm action
failure 2 times out.
Reagent bit = {0}, bar
Reagent Please re-scan after adding project
200015 code = {1}: unknown
tray parameters
new reagent!
Reagent bit = {0}, bar
Reagent Please confirm the reagent barcode and
200016 code = {1}: Reagent
tray rescan
bar code is invalid!

Alarm Alarm
number source
An error occurred Please check the corresponding reagent
data
300000 while querying the parameter settings to ensure that the project
processing
reference value. reference values are all set.
An error occurred
data Please check the corresponding reagent
300001 while calculating the
processing parameter settings.
test request result.
An error occurred Please check if the database service is
data
300002 while generating the correct or contact customer service
processing
test request. engineer.
An error occurred
data while calculating the Please check the corresponding reagent
300003
processing project results for the parameter settings.
sample.
An error occurred Please check if the database service is
data
300004 while updating the correct or contact customer service
processing
sample status. engineer.
The test result is out of
the valid range. Time
data = {0}, sample number Please check the status of the corresponding
300007
processing = {1}, item code = sample on the sample tray.
{2}, repeat number =
{3}.
Please check the previous fitting parameters
An error occurred
data and status of this item and ensure that the
300008 while auto-scaling the
processing number of standards is sufficient for the
reagent {0}: {1}.
current fit.
data The reagent bottle is Please check the reagent bottles at these
300009
processing empty, position: {0}. locations.
data Electrolyte calibration Please apply for electrolyte calibration
300018
processing failed again.
The requested barcode
data Please confirm that the LIS return
300020 {0} does not contain
processing information is correct.
any test items
Failed to send data to
data
300023 LIS via database. Please check if the LIS link is working.
processing
Sample number = {0}
The version of the
upper computer and
Communi the lower computer do
400022 cation not match, the upper Contact customer service engineer
board computer version {0},
the lower computer
version {1}
data Insufficient sample
400070 Add sample
processing size for {0} location

Alarm Alarm
number source
data No sample at {0}
400071 Add sample
processing location
data Insufficient reagent
400072 Add reagent
processing volume
data
400073 No reagent Add reagent
processing
Sample Sample driver module
400074 driver communication is Please check the sample driver module
module abnormal
Reagent Reagent R1 driver
400075 R1 drive module Please check the reagent R1 drive module
module communication error
Reaction Reaction disk module
400076 disk communication is Please check the reaction panel module
module abnormal
AD module
AD
400077 communication is Please check the AD module
module
abnormal
Exhaust is not
400078 Circuit Please check the circuit
completed
Network connection Please turn off the PC software first, then
error, network card is start the instrument until the network
60001 adapter
disabled or not connection is normal, then re-run the PC
connected software.
Communi Please close the PC software first, then
Communication is
60002 cation restart the instrument, and then re-run the
abnormal!
board PC software.
Communi
The data return length Please check the communication line or
60003 cation
is wrong! communication board.
board
Please check the communication line and
60004 adapter Not online!
re-run the PC software.
Please turn off the PC software, then start
The port number is
60005 adapter the instrument until the network connection
off!
is normal, and then re-run the PC software.
Please turn off the PC software, then start
The network
60006 adapter the instrument until the network connection
connection is broken!
is normal, and then re-run the PC software.
Communi The software does not
Please contact customer service engineer to
60010 cation match the instrument
re-configure the software.
board number!
When the probe is hit,
the instrument moves
60011 firing pin abnormally and the Please contact customer service engineer.
sample loading has
stopped.

Alarm Alarm
number source
Reagent information Please check the parameters of the reagent
Reagent
100000 was not found. and confirm that the reagent has been laid
tray
Reagent code = {0}. out on the reagent tray.
Test An error occurred Please check if the communication line is
100001 applicatio while downloading the normal and make sure the instrument is in
n test request. standby or working normally.
An error occurred
Test Please check if the communication line is
while the instrument
100002 applicatio normal and make sure the instrument is in
was starting to test the
n standby.
sample.
An error occurred
Please check the database parameters and
data while loading and
100010 status and contact customer service
processing refreshing the sample
engineers.
tray status.
Please check the database parameters and
data
100011 Auto review failed. status and contact customer service
processing
engineers.
data Invalid fit type code. Please check the previous fitting parameters
100012
processing Item = {0}. and status of this item.
The reaction tray
temperature is too low
Reaction
100013 to ensure that the test
tray
results are correct and
the test has stopped.
The reaction tray
temperature is too high
Reaction
100014 to ensure that the test
tray
results are correct and
the test has stopped.
The reaction tray
Reaction temperature is low and
100015
tray the test results may be
affected.
The reaction tray
Reaction temperature is too high
100016
tray and the test results
may be affected.
The reaction tray
Reaction temperature sensor is
100017
tray not connected or is
damaged.
data Invalid instrument Please try to reinstall the program or contact
100022
processing type. a customer service engineer.
Loading The loading arm is Please reboot or contact customer service
100023
arm initialized incorrectly. engineer.

Alarm Alarm
number source
Reaction Reaction disk moving Please reboot or contact customer service
100024
tray part initialization error engineer.
Mixing Stirring arm Please reboot or contact customer service
100025
arm initialization error engineer.
Unable to get alarm
Please check if the database service is
basic information from
100026 other correct or contact customer service
database <=
engineer.
AlarmID={0}
data Verification failed Please try to reinstall the program or contact
100031
processing after initialization a customer service engineer.
Instrument It is recommended to restart the lower
100032 other
initialization failed. computer.
The cup blank value is
Reaction below the lower limit Please clean the cuvette and replace the
200000
tray and the reaction cup cuvette if necessary.
number = {0}.
The cup blank value is
Reaction above the upper limit Please clean the cuvette and replace the
200001
tray and the reaction cup cuvette if necessary.
number = {0}.
Stirring Abnormal mixing
400080 drive module Please check the mixing module
module communication

Appendix A Electrical Schematic
43
Appendix B Liquid Road Connection Diagram
BK-200mini structure waterway map
44
Appendix C Product Support Reagents
See the table below (Xin Beisi Company's commonly used biochemical reagent parameter table).
Analy
Sampl Sub-E Norma
Sample R1 R2 Primary Wa sis Deci-mal Max Pri-Star Pri-End Sub-Sta
Item eType Unit Min Abs nd l High
Volume Volume Volume vele-ngth Meth Place Abs t Point Point rt Point
s Point Value
od
One
ALB 5 300 0 578 Point serum 1 g/L 0 3.3 30 30 0 0 55
End
Rate
ALP 6 240 60 405 metho serum 0 U/L 0 3.3 22 30 0 0 135
d
Rate
ALT 22 240 60 340 metho serum 1 U/L 0 3.3 23 33 0 0 41
d
Rate
AMY 7 250 90 405 metho serum 0 U/L 0 3.3 23 33 0 0 104
d
Two
ApoA1 5 225 75 340 Point serum 2 g/L 0 3.3 35 35 12 13 1.9
End
Two
ApoB 5 225 75 340 Point serum 2 g/L 0 3.3 35 35 12 13 1.5
End
Two
ASO 5 240 60 578 Point serum 0 IU/mL 0 3.3 28 29 19 20 166
End
AST 22 240 60 340 Rate serum 1 U/L -1 3.3 22 33 0 0 40
45
Analy
Sampl Sub-E Norma
s Point Value
od
metho
d
Fixed
time
BMG 5 225 75 578 serum 1 mg/L 0 3.3 21 28 0 0 1.8
metho
d
Rate
CHE 5 250 50 405 metho serum 0 U/L 0 3.3 22 30 0 0 12600
d
One
CHO 4 300 0 510 Point serum 2 mmol/L 0 3.3 15 15 0 0 5.2
End
Rate
CK 15 240 60 340 metho serum 0 U/L 0 3.3 22 30 0 0 190
d
Rate
CK-MB 15 240 60 340 metho serum 1 U/L 0 3.3 22 30 0 0 25
d
Fixed
time
CREA 15 240 60 510 serum 1 umol/L 0 3.3 22 30 0 0 115
metho
d
Two
CRP 20 225 75 340 serum 2 mg/dL 0 3.3 35 35 12 13 0.8
Point
46
Analy
Sampl Sub-E Norma
s Point Value
od
End
Two
DBIL 9 240 60 450 Point serum 2 umol/L 0 3.3 35 35 12 13 6.8
End
One
GLU 6 300 0 510 Point serum 2 mmol/L 0 3.3 34 35 0 0 6.4
End
Two
origina
HbA1c 10 225 75 630 Point 2 % 0 3.3 33 33 20 21 5.8
l blood
End
Rate
HCY 24 240 60 340 metho serum 1 umol/L 0 3.3 21 29 0 0 15
d
Two
HDL-C 5 225 75 546 Point serum 2 mmol/L 0 3.3 35 35 12 13 2.25
End
Rate
LDH 6 240 60 340 metho serum 0 U/L 0 3.3 22 30 0 0 225
d
Two
LDL-C 5 225 75 546 Point serum 2 mmol/L 0 3.3 35 35 12 13 3.35
End
Fixed
TBA 5 225 75 405 serum 1 umol/L 0 3.3 22 28 0 0 20
time
47
Analy
Sampl Sub-E Norma
s Point Value
od
metho
d
Two
TBIL 24 9 225 75 Point serum 0 umol/L
End
0 3.3 35 35 12 13 20.5
One
TG 5 300 0 510 Point serum 2 mmol/L 0 3.3 35 35 0 0 1.7
End
Two
UA 5 240 60 546 Point serum 0 umol/L 0 3.3 35 35 12 13 480
End
Fixed
time
UREA 5 225 75 340 serum 1 mmol/L 0 3.3 22 30 0 0 8.3
metho
d
One
TP 6 300 0 546 Point serum 1 g/L 0 3.3 34 35 0 0 88
End
Rate
α-HBDH 5 240 60 340 metho serum 0 U/L 0 3.3 22 30 0 0 182
d
Rate
GGT/γ-GT 6 225 75 405 metho serum 0 U/L 0 3.3 22 30 0 0 47
d
48
49
Appendix D: Cross Contamination Reference Sheet
Proj
Method
ect Method
principl Method principle
nam principle
e
e
Oxidase Enzymatic cycling
TG → TBA
methods assay
Oxidase Enzymatic cycling
TC → TBA
methods assay
CH Substrate
→ TG Oxidase method
E hydrolysis
LD Direct method of GLU(O
→ Oxidase method
L-C determination X)
HD Direct method of GLU(O
→ Oxidase method
L-C determination X)
CK IFCC → Mg Methylene Blue
FM NBT return Substrate

→ CHE
N method hydrolysis
The above cross-contamination only is taken for example when BIOBASE reagent is
tested on the BIOBASE series of Auto Chemical 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.
50
Jinan Biobase Biotech Co., Ltd
Biobase Biodustry (Shandong) Co., Ltd
Add: NO. 51 South Gongye Road, Jinan, China
Tel: +86-531-81219801/03 Fax: +86-531-81219804
E-mail: export@biobase.com
Web: www.biobase.com/www.biobase.cc
51

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BK 200mini User Manual 2019.5.4

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Auto Chemistry Analyzer

Jinan Biobase Biotech Co., Ltd

Thank you for purchasing BK-200mini Auto Chemistry Analyzer.

Dimensions and weight

Transportation and storage

Warranty and repair services

After-sales service and contact information

Please contact the company's customer service center

Company name: Jinan Biobase Biotech Co., Ltd

Protective For internal and external grounding. please ensure

Indicates that the transport package should be

Indicates that the transport package contains fragile

It indicates that the transport package is afraid of

Indicates that the shipping package cannot be rolled

Don‘t stack Indicates that the package can only be placed in a

Biological infection risk:

Prevent electric shock:

Prevent moving parts from causing personal injury:

Prevent light sources from causing personal injury:

Chemical danger protection:

Device is out of service:

Prevent electromagnetic waves and noise

Reagents, calibrators, QC products

Computer and printer

Use hoses or parts with liquids

This chapter provides a detailed introduction to the instrument in terms of

1.1 Installation requirements and steps

Power supply: AC220V/110V, Waste barrel

Display: 17 inches or more,

Computer host: CPU frequency≥2.8GHz，hard disk

1.1.1.1 Installation space requirements

1.1.1.2 Power requirements and protective grounding

1.1.1.3 Electromagnetic compatibility requirements

BK-200mini auto chemical analyzer radiation emission, conducted emission

1.1.1.4 Environmental requirements

1.1.1.5 Water supply and drainage

Biological infection risk:

1.1.2 Instrument installation

1.1.2.1 Unpacking step

Figure 1-4 Unpacking

1.1.2.2 Handling method

1.2 Instrument structure

1.2.1 Instrument appearance

Figure 1-5 Front view Figure 1-6 Right view

Figure 1-7 Rear view

Item Name Note

1 Top cover Protection loading system, detection unit, sample tray

Item Name Note

and reagent tray

3 Front panel Use when maintaining the instrument

6 Master power supply Instrument main control power switch

7 Refrigeration power supply Power switch for the cooling section

8 Switch Equipment operation switch

9 Fuse Safe operation of the protection circuit

10 Power input connector Used to power the device

11 Communication Interface Connect the analyzer to the computer

12 L frame Connected ground wire, pure water wastewater alarm,

13 Grounding bolt Connecting ground

16 water intake Connect polyurethane hose to provide pure water for

1.2.2 Instrument cover internal structure

Item Name Note

1 Reagent&sample tray Place reagent bottles, sample cups, blood collection

2 purge tank Cleaning reagent&sample probe or stirrer

3 Loading system Aspirate reagents and samples from the