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Automatic chemistry analyzer

BK-280

User Manual

Biobase Biodustry (Shandong) Co., Ltd


Description

Foreword

Thank you for purchasing Automatic chemistry analyzer.


Product name: Automatic chemistry analyzer
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: Biobase Biodustry (Shandong) Co., Ltd
Address: No.9 Gangxing Road, High-tech Zone, Jinan City, Shandong Province,
China
Production date: Check product label
Period of use:
The expected life of the instrument is 5 years. The expected service life of this product
is determined by the durability test method. The operator maintains and repairs the
product according to the requirements of the user manual.

Description -I
Description

Revision statement

This document applies to the latest and higher version of the software listed.
File Name: Automatic chemistry analyzer User Manual
Version: V3.0
Last update: Oct., 2021
Contents: This manual describes in detail the use of the product, function and use of
methods to ensure that the clinical laboratory technician to carry out the smooth
detection of the daily work, recorded the relevant daily maintenance content. The
pictures in this manual are only for illustrative and illustration and not intended for
any other purpose. The actual picture is subject to the product. In this manual, the
mouse operation as an example, explain the various methods of operation.

Description -II
Description

Intellectual property

The intellectual property of this user manual and its corresponding products belongs to
Biobase Biodustry (Shandong) Co., Ltd. (hereinafter referred to as “our company” or
“us”).
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 our company.
If the contents of this user manual are changed, the user will not be notified

Description -III
Description

Statement

Biobase Biodustry (Shandong) Co., Ltd (hereinafter referred to as “our company” or


“us”) has the final interpretation right of this user manual.
Our 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 our company.
 All repairs involving replacement parts and supporting accessories and consumables
are original (original) or approved by our 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.

Description -IV
Description

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.
 Personnel 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.

Description -V
Description

Dimensions and weight

External size: 950mm×603mm×1075mm


Net weight: 110kg
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 main supply.
g) Applicable rated pollution level.
h) No abnormal noise equipment nearby.
i) The equipment complies with the emission and immunity requirements of IEC
61326-1. 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.
Note:
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.

Description -VI
Description

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 our company or the agent designated
by our 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 our company.
 Failure and damage caused by the inconsistency between the operating
environment and the operating environment (power supply conditions,
installation environment, etc.) specified by our company.
 Failure and damage caused by irresistible natural disasters.
 Failure and damage caused by our 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 our company, it is not within the scope of our 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, our company can continue to provide
fee-based repair services.

Description -
Description

After-sales service

 After sales service


Please contact our 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 our company according to the specific
situation.
c) Freight: If the instrument is shipped to our company for maintenance, the user
must bear the freight (including customs fees).
 Return
a) Obtain a return permission. Get in touch with our 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, our company will not return the product.
b) Under the premise of obtaining the right to return the goods, please follow our
company's requirements to handle the relevant procedures.
 Contact information

Company: Biobase Biodustry (Shandong) Co., Ltd


Address: No.9 Gangxing Road, High-tech Zone, Jinan City, Shandong Province,
China
Service Email: service_ivd@biobase.cc
Phone: +86-531-81219801/03
Zip code: 250000

Description -
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:
 Description page
 Preface
 Security Information
 Chapter 1 System Overview
 Chapter 2 Basic Operation
 Chapter 3 System Setting
 Chapter 4 Calculation Method
 Chapter 5 Reagent Application
 Chapter 6 Calibration Test
 Chapter 7 QC Test
 Chapter 8 Sample Test
 Chapter 9 Data Processing
 Chapter 10 Item Parameters
 Chapter 11 System Function
 Chapter 12 LIS Transmission Operation Method
 Chapter 13 Maintenance
 Chapter 14 Alarm and Fault Handling
 Appendix
Catalogue

Catalogue

Foreword ......................................................................................................................................................... I
Security Information ....................................................................................................................................... I
1 System Overview ........................................................................................................................................ 1
1.1 Installation Requirements and Steps ................................................................................................ 2
1.1.1 Installation Requirements ...................................................................................................... 2
1.1.2 Instrument Installation........................................................................................................... 7
1.2 System Connection........................................................................................................................... 9
1.2.1 Overall Structure ................................................................................................................. 11
1.2.2 Reagent&sample Processing System .................................................................................. 14
1.2.3 Reaction System .................................................................................................................. 20
1.2.4 Cleaning System.................................................................................................................. 22
1.2.5 Mixing System .................................................................................................................... 23
1.2.6 Photoelectric Colorimetric System...................................................................................... 24
1.2.7 Operation System ................................................................................................................ 25
1.2.8 Peripheral Equipment .......................................................................................................... 25
1.2.9 Accessories and Consumables ............................................................................................ 25
1.2.10 Laboratory Water Purifier ................................................................................................. 25
1.3 Optional Modules ........................................................................................................................... 25
1.4 Software Introduction and Operation ............................................................................................. 26
1.4.1 Software Interface ............................................................................................................26
1.4.2 Mouse Usage ....................................................................................................................... 30
1.5 System Parameter ........................................................................................................................... 30
2 Basic Operation ........................................................................................................................................... 1
2.1 Operate Chart ................................................................................................................................... 2
2.2 Check Before Power on ................................................................................................................... 2
2.2.1 Check the Water Supply ........................................................................................................ 2
2.2.2 Check the Power Supply ....................................................................................................... 2
2.2.3 Check Printer Paper............................................................................................................... 2
2.2.4 Check Waste Liquid Connection........................................................................................... 3
2.2.5 Inspection of Probes .............................................................................................................. 3
2.3 Turn on Analyzer ............................................................................................................................. 3
2.3.1 Turn on the Power ................................................................................................................. 3
2.3.2 Software ................................................................................................................................ 4
2.4 Instrument Status Confirmation ....................................................................................................... 6
2.5 Preparation for Reagent.................................................................................................................... 6
2.5.1 Preparation for Reagent ......................................................................................................... 7
2.5.2 Loading Reagent Manually ................................................................................................... 7
2.6 Calibration Test .............................................................................................................................. 10
2.6.1 Calibration Testing .............................................................................................................. 10
2.6.2 Prepare Calibration Products ............................................................................................... 11
2.6.3 Start Calibration Test .......................................................................................................... 12
2.7 QC .................................................................................................................................................. 12
2.7.1 QC Test ............................................................................................................................... 12
2.7.2 Prepare QC Product............................................................................................................. 13
2.7.3 Start QC Testing .................................................................................................................. 13
2.8 Sample Testing ............................................................................................................................... 14
2.8.1 Regular Sample Testing ...................................................................................................... 14
2.8.2 Preparing Regular Samples ................................................................................................. 16
2.8.3 Test Start ............................................................................................................................. 17
2.9 Emergency Sample Test (STAT) ................................................................................................... 17
2.9.1 Emergency Sample Input .................................................................................................... 17
2.9.2 Preparing Emergency Sample ............................................................................................. 18
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Catalogue

2.9.3 Testing Start ......................................................................................................................... 19


2.10 Testing Status and Control............................................................................................................ 19
2.11 Daily Maintenance ........................................................................................................................ 21
2.12 Shutdown ...................................................................................................................................... 21
2.13 Operation after Shutdown ............................................................................................................. 22
3 System Setting ............................................................................................................................................. 1
3.1 System Setting .................................................................................................................................. 2
3.1.1 Brief Introduction .................................................................................................................. 2
3.1.2 Sample Information and Test Information Setting ................................................................ 2
3.1.3 LIS Transmission Mode Setting ............................................................................................ 2
3.1.4 User Setting ........................................................................................................................... 2
3.2 Item Setting....................................................................................................................................... 2
3.2.1 Brief Introduction .................................................................................................................. 2
3.2.2 Basic Parameter Setting ......................................................................................................... 3
3.2.3 Correction Coefficent Setting ................................................................................................ 7
3.3 Calibration Setting ............................................................................................................................ 7
3.3.1 Introduction............................................................................................................................ 7
3.3.2 Calibrator Settings ................................................................................................................. 7
3.3.3 Delete Calibrators .................................................................................................................. 9
3.4 QC Setting ........................................................................................................................................ 9
3.4.1 Brief Introduction .................................................................................................................. 9
3.4.2 Add/modify QC Products .................................................................................................... 10
3.4.3 Item Selection ...................................................................................................................... 11
3.4.4 QC Settings .......................................................................................................................... 11
3.4.5 Set QC Rules........................................................................................................................ 12
3.4.6 Delete the QC ...................................................................................................................... 12
3.5 Maintenance Item ........................................................................................................................... 13
3.5.1 Introduction.......................................................................................................................... 13
3.5.2 Maintenance Settings for Individual Items .......................................................................... 13
3.5.3 Maintenance Combination Project Setting .......................................................................... 14
4 Calculation Method ..................................................................................................................................... 1
4.1 Introduction ...................................................................................................................................... 2
4.2 Analysis Method ............................................................................................................................... 2
4.3 Endpoint Method .............................................................................................................................. 3
4.3.1 Brief Introduction .................................................................................................................. 3
4.3.2 One Endpoint Method............................................................................................................ 4
4.3.3 Two Endpoint Method ........................................................................................................... 4
4.4 Fixed Time Method .......................................................................................................................... 5
4.4.1 Brief Introduction .................................................................................................................. 5
4.4.2 Calculation ............................................................................................................................. 6
4.5 Rate Method ..................................................................................................................................... 7
4.5.1 Brief Introduction .................................................................................................................. 7
4.5.2 Calculation ............................................................................................................................. 7
4.6 Calibration Method ........................................................................................................................... 8
4.6.1 Brief Introduction .................................................................................................................. 8
4.6.2 Linear Calibration .................................................................................................................. 8
4.6.3 Nonlinear Method ................................................................................................................ 12
5 Reagent Application .................................................................................................................................... 1
5.1 Summary ........................................................................................................................................... 2
5.1.1 Brief Introduction .................................................................................................................. 2
5.1.2 Overview of Reagent Information Interface .......................................................................... 2
5.2 Alarm Limit Setting for Reagent Remaining Amount ...................................................................... 2
5.2.1 Brief Introduction .................................................................................................................. 2
5.2.2 Alarm Limit for Reagent Remaining Amount ....................................................................... 3
5.3 Reagent Remaining Amount Detection ............................................................................................ 3
5.3.1 Brief Introduction .................................................................................................................. 3
5.3.2 Detection Reagent Balance .................................................................................................... 3
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Catalogue

5.3.3 Manually Refresh Reagent Remaining Amount.................................................................... 4


5.3.4 Cancel Remaining Amount Detection ................................................................................... 4
5.4 Print Reagent Information ................................................................................................................ 4
5.4.1 Brief Introduction .................................................................................................................. 4
5.4.2 Print Reagent Information ..................................................................................................... 4
5.5 Loading Reagent .............................................................................................................................. 5
5.5.1 Brief Introduction .................................................................................................................. 5
5.5.2 Reagent Entry ........................................................................................................................ 6
5.5.3 Loading Reagent Steps .......................................................................................................... 7
5.6 Replacement Reagent ....................................................................................................................... 7
5.6.1 Brief Introduction .................................................................................................................. 7
5.6.2 Replacement Reagent Steps .................................................................................................. 8
5.7 Unloading Reagent ........................................................................................................................... 8
5.7.1 Brief Introduction .................................................................................................................. 8
5.7.2 Unloading Reagents Steps..................................................................................................... 8
6 Calibration Test ........................................................................................................................................... 1
6.1 Summary .......................................................................................................................................... 2
6.2 Calibration Parameter Setting .......................................................................................................... 2
6.3 Calibration Item Input ...................................................................................................................... 3
6.4 Calibration Test ................................................................................................................................ 5
6.5 Verification of Calibration Result .................................................................................................... 6
6.5.1 View Reaction Curve ............................................................................................................ 6
6.5.2 Query Calibration Result ....................................................................................................... 6
7 QC Test ....................................................................................................................................................... 1
7.1 Summary .......................................................................................................................................... 2
7.2 QC Rules Setting .............................................................................................................................. 2
7.2.1 Brief Introduction .................................................................................................................. 2
7.2.2 QC Rules Setting ................................................................................................................... 2
7.3 QC Information Entry ...................................................................................................................... 4
7.4 QC Item Input .................................................................................................................................. 5
7.5 QC Test ............................................................................................................................................ 7
7.6 Verification QC Results ................................................................................................................... 8
7.6.1 View Reaction Curve ............................................................................................................ 8
7.6.2 QC Result Query ................................................................................................................... 9
7.6.3 Out of Control Analysis ...................................................................................................... 11
7.6.4 Print QC Chart..................................................................................................................... 11
7.6.5 Print QC Report................................................................................................................... 11
8 Sample Test ................................................................................................................................................. 1
8.1 Summary .......................................................................................................................................... 2
8.2 Sample Test Method ........................................................................................................................ 2
8.2.1 Brief Introduction .................................................................................................................. 2
8.2.2 Sample Input ......................................................................................................................... 2
8.2.3 Additional Sample Test ......................................................................................................... 4
8.2.4 Modification/ Additional Item Testing.................................................................................. 5
8.2.5 Sample Retest ........................................................................................................................ 6
8.2.6 Sample Processing................................................................................................................. 9
8.3 Cancel Sample Test ........................................................................................................................ 10
8.4 Sample Test .................................................................................................................................... 11
8.5 Sample Positions ............................................................................................................................ 12
8.5.1 Introduction ......................................................................................................................... 12
8.5.2 Monitoring the Sample Tray ............................................................................................... 12
8.6 Test Result Query........................................................................................................................... 13
8.6.1 Introduction ......................................................................................................................... 13
8.6.2 Sample Test Result View .................................................................................................... 13
8.6.3 View Reaction Curve .......................................................................................................... 15
9 Data Processing ........................................................................................................................................... 1
9.1 Data Export ...................................................................................................................................... 2
9.1.1 Introduction ........................................................................................................................... 2
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Catalogue

9.1.2 Export data to LIS System Host............................................................................................. 2


9.2 Data Backup ..................................................................................................................................... 3
9.2.1 Database Maintenance ........................................................................................................... 3
9.2.2 Data Statistics ........................................................................................................................ 4
9.3 Data Maintenance ............................................................................................................................. 5
9.3.1 Introduction............................................................................................................................ 5
9.3.2 Data Items Setting.................................................................................................................. 6
9.3.3 Project Test Order .................................................................................................................. 6
9.3.4 Prevent Cross Contamination ................................................................................................ 7
9.3.5 Print Order ............................................................................................................................. 8
9.3.6 Manually Item Reference Setting .......................................................................................... 8
9.3.7 Cup Type Setting ................................................................................................................. 10
9.4 Print Settings................................................................................................................................... 11
9.4.1 Introduction.......................................................................................................................... 11
9.4.2 Print Page Settings ............................................................................................................... 11
9.5 Sample Report Printing................................................................................................................... 12
9.5.1 Introduction.......................................................................................................................... 12
9.5.2 Sample Report ..................................................................................................................... 12
9.6 Reagent Report Print....................................................................................................................... 14
9.6.1 Introduction.......................................................................................................................... 14
9.6.2 List of Reagent Information ................................................................................................. 14
9.7 QC Report Print .............................................................................................................................. 15
9.7.1 Introduction.......................................................................................................................... 15
9.7.2 QC Result............................................................................................................................. 15
9.8 Operation Log ................................................................................................................................. 16
9.8.1 Introduction.......................................................................................................................... 16
9.8.2 Login Log ............................................................................................................................ 16
9.8.3 Operation Log ...................................................................................................................... 17
9.8.4 Maintenance Log ................................................................................................................. 17
10 Item Parameters ......................................................................................................................................... 1
10.1 Manually Input Items ...................................................................................................................... 2
10.1.1 Introduction.......................................................................................................................... 2
10.1.2 Design / Edit Manual Input Item ......................................................................................... 2
10.1.3 Inputting Results of Manually Input Items .......................................................................... 2
10.2 Calculated Item ............................................................................................................................... 2
10.2.1 Introduction.......................................................................................................................... 2
10.2.2 Design / Edit Calculation Item............................................................................................. 2
10.2.3 Calculated Item Results Query ............................................................................................ 3
10.3 Profile Items Setting and Application ............................................................................................. 3
10.3.1 Introduction.......................................................................................................................... 3
10.3.2 Design/Edit Profile Item ...................................................................................................... 3
10.3.3 Profile Items Query.............................................................................................................. 4
11 System Function ........................................................................................................................................ 1
11.1 User Setting and Password Settings................................................................................................ 2
11.1.1 Introduction.......................................................................................................................... 2
11.1.2 Adding Users ....................................................................................................................... 2
11.1.3 Deleting Users ..................................................................................................................... 3
11.1.4 Change User Password ........................................................................................................ 3
11.2 Version Information........................................................................................................................ 5
12 LIS Transmission Operation Method ........................................................................................................ 1
12.1 Overview ........................................................................................................................................ 2
12.2 LIS Communication Parameter Settings......................................................................................... 2
12.2.1 Introduction.......................................................................................................................... 2
12.2.2 Setting LIS Communication Parameters.............................................................................. 2
12.3 Sample Test Connected to LIS ....................................................................................................... 3
12.3.1 Introduction.......................................................................................................................... 3
12.3.2 Sample Testing for Linking LIS .......................................................................................... 3
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Catalogue

13 Maintenance .............................................................................................................................................. 1
13.1 Overview ........................................................................................................................................ 2
13.1.1 Introduction ......................................................................................................................... 2
13.1.2 Accessories Information ...................................................................................................... 2
13.1.3 Maintenance Supplies and Tools......................................................................................... 3
13.2 Regular Maintenance ..................................................................................................................... 4
13.2.1 Introduction ......................................................................................................................... 4
13.2.2 Maintenance Period Definition ........................................................................................... 4
13.2.3 Maintenance Contents ......................................................................................................... 5
13.3 Daily Maintenance ......................................................................................................................... 6
13.3.1 Check Probe / Stirrer / Cleaning Needles / Cleaning Tank ................................................. 6
13.3.2 Check Pure Water Connection ............................................................................................ 8
13.3.3 Check Waste Connection .................................................................................................... 8
13.3.4 Cuvette Detection ................................................................................................................ 9
13.3.5 Water Pipe Maintenance ................................................................................................... 10
13.4 Weekly Maintenance .................................................................................................................... 10
13.4.1 Cleaning the Out Walls of Probes ..................................................................................... 10
13.4.2 Cleaning Condensed Water ............................................................................................... 12
13.5 Monthly Maintenance .................................................................................................................. 12
13.5.1 Cleaning Tanks.................................................................................................................. 12
13.6 Maintenance Every Three Months ............................................................................................... 13
13.6.1 Replacing the Cuvettes ...................................................................................................... 13
13.6.2 Cleaning the Reaction Tank .............................................................................................. 15
Operation steps............................................................................................................................................. 15
13.7 Maintenance Every Six Months ................................................................................................... 15
13.7.1 Replacing the Light Source ............................................................................................... 15
Operation steps............................................................................................................................................. 17
13.8 Unscheduled Maintenance ........................................................................................................... 19
13.8.1 Cleaning the Panels ........................................................................................................... 19
Operation steps............................................................................................................................................. 20
13.8.2 Cleaning Reagent & Sample Tray ..................................................................................... 20
13.8.3 Cleaning the Inner Wall of Probes .................................................................................... 21
13.8.4 Cleaning the Inner Wall of Cleaning Needles ................................................................... 26
13.8.5 Replacing the Sampling Probe .......................................................................................... 29
13.8.6 Replacing the Stirrer.......................................................................................................... 30
13.8.7 One key auto gain calibration............................................................................................ 33
13.8.8 Replacing the Cuvette ....................................................................................................... 35
13.8.9 Add Coolant ...................................................................................................................... 36
13.8.10 Add Cleaning Solution C ................................................................................................ 37
14 Alarm and Fault Handling ......................................................................................................................... 1
14.1 Troubleshooting Methods .............................................................................................................. 2
14.1.1 Introduction ......................................................................................................................... 2
14.1.2 Observing Instrument Failure Prompt ................................................................................. 2
14.2 Instrument Faults and Handling ..................................................................................................... 3
Appendix A: Electrical Schematic Diagram ................................................................................................... I
Appendix B: Water System Diagram ............................................................................................................. II
Appendix C: Reagents Parameter Sheet....................................................................................................... III
Appendix D: Cross Contamination Reference Sheet .....................................................................................V

Catalogue -5
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. It also lists whether the
content of toxic and harmful substances or elements contained in each component
meets the relevant standards.
Security Information

Safety symbol

Various safety symbols are used in this user manual and the 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
In all cases marked with this warning mark it is
necessary to consult the user manual in order to ascertain
the nature of the potential hazard and any action that
Caution
must be taken.If you do not follow the instructions in the
user manual to use the device, the protective measures
provided by the device may fail.
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.
Caution, hot Used for halogen lamp position. Indicates a burn hazard
surface and may be burnt if contacted or not followed.
Used to indicate a static-sensitive device or to indicate a
Electrostatic
device or connector that has not been tested for
sensitive device
antistatic.
Used for the position of moving parts such as sample
arm, stirring arm, cleaning mechanism, etc.. Indicating
Be careful to get potential danger, forbidden to touch the moving parts
involved in during operation to avoid getting involved in, if not in
accordance with the instructions, may cause personal
injury.
Protective For internal and external grounding. Please ensure that
conductor terminal the instrument is well grounded.
At the nameplate position. Indicates manufacturer
Manufacturer
information.
Refer to the At the nameplate position. For other information, see the
instructions user manual.
In vitro diagnostic At the nameplate position. Indicates that the medical
instrument instrument is an in vitro diagnostic medical instrument.
European
At the nameplate position. Represents the authorized
Authorized
representative of the European Union.
Representative
At the nameplate position. Represents the authorized
CE mark
representative of the European Union.
Indicates correct upright position of the transport
This way up
package.
Contents of the transport package are fragile therefore it
Fragile
shall be handled with care.

Keep away from


Transport package shall be kept away from rain.
rain

Do not roll Transport package shall not be rolled.

Stacking of the transport package is not allowed and no


Do not stack
load should be placed on the transport package.

System Information -II


Security Information

Safety precautions
Introduction
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.
Caution:
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


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 getting involved in moving parts during operation


Prevent getting involved in moving parts during
operation:
 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.

Electrostatic sensitive device


Electrostatic sensitive device:
Paste on the probe cover and mark the probe as a static sensitive
device to prevent direct contact between hands and clothing.

System Information -III


Security Information

Caution, hot surface


Caution, hot surface:
 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 and wait at least 20 minutes for the
halogen lamp to cool down, otherwise the high temperature
halogen lamp and the light source box may cause burns.

Prevent light sources from causing personal injury


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 20 minutes until the light source
cools. Do not touch the light source before it cools down to
avoid burns.

Chemical danger protection


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
Waste treatment:
 Some substances in reagents, controls, calibrators, cleaning
solutions, 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


Prevent fires and explosions:
Alcohol is flammable and must be used with great care.

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Security Information

Processing components and instrument


Processing components and instrument:
Some substances in discarded components and instruments are
subject to pollution regulations. Dispose of used instruments in
accordance with local waste disposal standards.

Instrument is out of service


Instrument is out of service:
 Before the instrument is transported, please cut off the power
and cover the reagent bottle, remove the sample and cover the
instrument to avoid biological risks or other hazards in the
process of transportation.
 Before the maintenance process, please cut off the power ,
clean and disinfected the surface of the instrument, reagent
sample needles, stirring needles and other parts with
biological risks, and remind the relevant personnel of the risks
of the instrument to avoid biological risks or other hazards
during maintenance.
 While the instrument processing, some substances in discarded
components and instruments are subject to pollution
regulations. Dispose of used instruments in accordance with
local waste disposal standards.

System Information -V
Security Information

Operational precautions
Introduction

In order to use the instrument correctly and effectively, please read the following
precautions carefully.

Instrument use
Caution:
 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 our
company's customer service center or distributor in your area.

System installation
Caution:
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 IEC 61010-2: 2001 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.

System Information -
Security Information

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 our 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 our 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.

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Security Information

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.

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 our 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.

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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 our company.
 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.

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.

System Information -
Security Information

Reagents, calibrators, QC products


Be careful:
 When using this instrument for analysis, you need appropriate
reagents, calibrators, and QC products.
 Please select the matching reagent according to this instrument.
If you are not sure if the reagent is available, please consult our
company or our 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.

Computer and printer


Note:
Please refer to the instructions for use of the computer and
printer.

Use hoses or parts with liquids


Caution:
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 Information -
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 operation

 System specification
System Overview

1.1 Installation Requirements and Steps


1.1.1 Installation Requirements
Instrument installation example is as follows:
The distance from wall to left or right panel is more than 50cm.
The distance from wall to back panel is more than 50cm.
The distance between analyzer and other instrument is more than 100cm.
Ensure there’s enough space for installation of waste and purified water equipments.
Grounding
method: first the
wire ends
stripping, then the Cooling Power and
wire end passes operation power
through the
grounding bolt
hole, and screw
the nut on the
ground. The
ground should be
pressed into the Power supply: AC220V/110V,
building ground. 50H/60Hz
Instrument power:300VA
Instrument is equipped with a
Waste bucket three core power line, red for
is connected fire wire, blue for zero line,
with the water greenyellow for ground wire.
outlet of the
instrument by
snake skin
pipe. And folat UPS:
switch Power≥1000W
detection level

Pure water
bucket is
connected with Power Supply
the water inlet Socket
by the TPU
pipe ,and level
detection of
float switch. The power socket analyzer using
Monitor:17inches or more,
needs good grounding (at least
resolution is not less than
three 5A socket can be used.)
1366*768.

Computer configuration: Must be a branding machine which CPU


frequency ≥ 2.8GHz, hard disk ≥ 80G, memory ≥ 2G.TCP/IP internet
interface, RS-232,USB2.0 interface. Operation system: Windows 7 or Printer: ordinary inkjet or laser
above, 32 bits or 64 bits. Already installed the special software. printer that prints the measured
data.

Figure 1-1 Installation example


The connecting line in the figure 1-1 indicates the corresponding pipe or wire. The
communication port is connected to the computer network port through a network cable,
the power input port is connected to the UPS power supply through a power cable, the
water inlet port is connected to the pure water tank through the water inlet pipe, and the

System Overview -2
System Overview

outlet port 1 and 2 is connected to the waste liquid tank or the waste liquid discharge outlet
through the corresponding outlet pipe.
1.1.1.1 Installation space requirements
In order to facilitate the operation, maintenance and repair of the instrument, the 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.

Figure 1-2 Installation space view


1.1.1.2 Power requirements and protective grounding
Power supply: AC220V/110V, 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 -3
System Overview

Figure 1-3 Grounding bolt

Caution:
Protective grounding must be good to prevent electric shock and instrument
failure.

1.1.1.3 Electromagnetic compatibility requirements


The analyzer radiation emission, conducted emission should meet the requirements of
CISPR11 group Ⅰ 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.
The 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.
 The analyzer is designed and tested according to group Ⅰ class A equipment in
CISPR11. 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

Basic EMC Performance


Port Test items Test value
standard criterion
Electrostatic Air discharge: ±2/4/8kV
discharge IEC 61000-4-2 Contact discharge: ±2/4kV A
(ESD) Indirect discharge: ±2/4kV
Radiated frequency: 80MHz~2.0GHz
Shell electromagnetic IEC 61000-4-3 Level: 3V/m A
field modulation: 80%AM@1kHz
Rated power
frequency IEC 61000-4-8 Level: 3A/m ,50Hz A
magnetic field

System Overview -4
System Overview

Basic EMC Performance


Port Test items Test value
standard criterion
0%, 1 cycle A
Voltage dip IEC 61000-4-11 40%, 5 cycle A
70%, 25 cycle A
Voltage
IEC 61000-4-11 5%, 5s C
interruption
AC Burst IEC 61000-4-4 1kV: (5/50ns ,5KHz) A
power
Line to ground: ±2kV
Surge IEC 61000-4-5 A
Wire-to-line: ±1kV

frequency: 15kHz~80MHz
Radio frequency
IEC 61000-4-6 Level: 3V A
conduction
modulation: 80%AM@1kHz

System Overview -5
System Overview

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.
The 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 300 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.

Caution:
The accuracy of normal operation and test data cannot be guaranteed for the
instrument in environments other than those described above. If the
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 5L/hour. It is recommended to choose a 15L water
purifier.

Caution:
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

System Overview -6
System Overview

liquid barrel mouth (or special discharge port for waste liquid), and the length of the waste
pipe should not exceed 2m.
Biological infection risk:
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


Caution:
In order to ensure the normal operation of the instrument after installation,
the installation and initial setting of the instrument, please contact us.

1.1.2.1 Unpacking step


After the instrument arrives, please check the packaging of the instrument carefully to see
if there is physical damage, and check whether the monitored shipment label (anti-tilting
and anti-touch) is red. If there is any damage or the indicator is red, please contact our
company or local agent.

Figure 1-4 Anti-tilting Figure 1-5 Anti-touch

The indicator is red

Figure 1-6 Anti-tilting

System Overview -7
System Overview

The indicator is red

Figure 1-7 Anti-touch


After confirming that there is no external damage, follow the steps below to unpack:
 Remove the wooden packing box from the truck, it is recommended to use a forklift.
 Open the top cover of the packing box and take out the accessory box and barrels as
shown in Figure 1-8. Open the accessory box and take out the accessory list and
check whether all the accessories are complete.
 Use the tools in the accessory box to unpack the box, remove the foam pads, and
disassemble the instrument's sealing film.
 Place the instrument in a place that meets the requirements of the installation
environment.

Figure 1-8 Open the top cover

System Overview -8
System Overview

Figure 1-9 Accessories

Figure 1-10 The analyzer


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 System Connection


The system connection refers to the connection between the analyzer and other peripheral
devices. The detailed connection method is shown in figure 1-11.
System Overview -9
System Overview

Printer. Inkjet or laser


Monitor:17 inches or more, printer, the
not less than 1366*768 measurement date for
resolution. printing.

Communication line

Mainframe computer: Must be a branding machine. CPU


frequency≥2.8GHz,hard disk≥80GB,memory≥2GB.
Internet and stable USB interface. Operating system:
Windows 7 or above,32bits or 64 bits. Already installed
Microsoft.NET Frame Work3.5 and software of the
analyzer. It’s recommended to install Microsoft Office
Access software.

Operational Unit Analytical Unit

Figure 1-11 System connection


The analyzer consists of photoelectric colorimetric system, sample introduction system,
control system and software components. The photoelectric colorimetric system, sample
introduction system and control system form the analysis department.
The analysis department is the analyzer host, which is mainly used to analyze samples,
measure the clinical chemistry of various samples, and generate result data. The detailed
components of the analysis department are as follows:
 Reagent & Sample processing system
 Control system
• Reaction system
• Cleaning system
• Mixing system
 Photoelectric colorimetric system
The operation department is the analyzer software component, which completes the test
application, test, reaction process monitoring, result calculation and data input, storage and
query.
Accessories and consumables include cuvettes, light sources, etc.
Peripheral devices include computers, monitors, printers, mice, keyboards, water purifier,
etc.

System Overview -10


System Overview

1.2.1 Overall Structure


1.2.1.1 Instrument appearance
1 2

Figure 1-12 Front view

1
1

5 7

6 8

Figure 1-13 Right view Figure 1-14 Rear view

System Overview -11


System Overview

16

10
17
15
9

18

11 13

12

15
14
1 19

Figure 1-15 Rear view

No Name Note
1 Top cover Protect the sampling system, stirring system and reaction system.
Here you can observe the working conditions of the internal
2 Observation window
systems, such as sampling system ,stirring system, etc.
3 Front panel Strike when maintenance the machine.
Bottom cabinet
4 Table and lockers.
(Optional)
5 Alarm indicator lamp Liquid level alarm and temperature alarm.
6 Right panel Strike when adding coolant and maintenance water system.
7 Power switch Operation switch and cooling switch.
8 Left panel Power switch is located on the left side panel.
Connect grounding cable, water alarm float switch and water tube
9 L-type support
connection.
10 Power panel Open or close power supply and power cable connection.
11 Earth stud Used to connect grounding cable.
12 Aviation joint Connect water alarm float switch to alarm purifier and waste water.
13 Vent Used for the gas out of the pure water tank.
14 Outfall Connect armored tube, empty waste water.
15 Inlet Connect silicone tube, provide purifier water.
Communication
16 Used to connect analyzer and PC.
interface
17 Fuse Protect the safe operation of the circuit.
18 Main switch Used to control the main power of the analyzer.
19 Power cable Connect power supply.

System Overview -12


System Overview

1.2.1.2 Instrument cover internal structure

3
4 6
5
2
1
2

Figure 1-16 Internal structure


No Name Note
1 R&S tray Put reagent bottle, sample cup and test tube.
2 Cleaning tank Clean R&S probe.
Extraction reagent and sample from R&S tray, and
3 Sample system
distribute to the cuvettes.
4 Mixing system Mix reagent and sample in the cuvettes.
Fixed cuvettes, keep suitable temperature and provide
5 Reaction system
reaction conditions.
6 Cleaning system Used to clean cuvettes.
1.2.1.3 Instrument movement structure
20 1 2 3 4 5 6 7 8 9 10

11 12 13 14 15 16 17 18 19
1-Circuit board, 2-Water L frame, 3-R&S arm, 4-Stirring arm, 5-cleaning tank,
6-Pinboard of AD, 7-Halogen lamp, 8-Terminal block, 9-Optical component, 10-Cleaning arm,
11-Baseplate, 12-R&S tray, 13-Pinboard, 14-Sample pump, 15-cleaning tank, 16-Coolant tank,
17-Reaction tray, 18-Pure water tank, 19-Pump and valve component, 20-Circulating pump
Figure 1-17 Instrument structure

System Overview -13


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, a photoelectric colorimetric system, a liquid path system, and an
alarm system.

1.2.2 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 the sample
(reagent), and then injected into the cuvette to react with the reagent (sample).
Photoelectric colorimetric system measures the absorbance of the reaction solution.
The reagent&sample processing system is mainly composed of the following components:
 Reagent&sample tray assembly
 Sampling system
 Sample tube
 Reagent bottle
 Cooling system
 Reagent barcode scanning component (Optional)
1.2.2.1 Reagent&sample tray assembly

Reagent & sample tray Insulation

Sample tube
Cooling
assembly
Reagent bottle

Reagent & sample pot

Stepping
motor

Figure 1-18 Reagent &sample processing system


 Reagent&sample tray assembly

1
3

2
5

1-positioning plate, 2-Stepping motor, 3-Shaft, 4- Pot, 5-Fixing seat


(a)

System Overview -14


System Overview

2
3

1- Sample area, 2-Reagent area, 3-Handle, 4-Fixing base.


(b)
Figure 1-19 R&S tray structure
As shown in Figure 1-19(a), the reagent&sample tray is composed of fixing seat, pot, shaft,
positioning plate, stepping motor, reagent&sample tray, handle,etc. When the analyzer is
initialized, the stepping motor drives the tray to rotate, send the designated sample or
reagent to the sampling position.
When installation, the reagent&sample tray must aim at the pin, make the tray level, with
the hand gently turns non-slip, then tighten the handle. When disassemble the tray,
unscrew the handle counterclockwise then take out whole tray.
When check movement, find the “Instrument Check”, and input target value in “Target”,

then Click Y to check, as the figure shown . “Zero”


position is back to original position. After test is completed, click “Zero”.
1.2.2.2 Sampling system
The sampling system consists of a sampling arm, a plunger pump and a solenoid valve.
The volume of reaction with reagent is controlled by the solenoid valve and the plunger
pump, as shown in Figure 1-20.

Sampling arm Plunger pump and solenoid valve


Figure 1-20 The component of loading sampling system
The sampling arm consists of a sampling probe, a spline shaft, a stepping motor,
photoelectric switch and other components, as shown in figure 1-21.

System Overview -15


System Overview

2
7

3
8
4
9
10
11
12
5

Figure 1-21 Sampling arm


As figure 1-22 shown, the sampling probe consists of anti-collision base, up fixed screw,
spring, adapter sleeve and nut.

Nut

Up fixed screw

Spring

Adapter sleeve

Anti-collision base

Figure 1-22 Sampling probe


Sampling arm can add sample and reagent to the reaction cup.
The sample adding function is used to take quantitative sample from the sample cup, and
fill it into the reaction cuvette. Sampling probe has liquid level detection function. If
sampling probe collides in the process of decline, it will execute anti-collision protection
procedure. The probe will return to the highest place and stop. After the anti-collision
protection is started, after the test of the sampled items is completed, the software prompts
the alarm, initializes the operation of eliminating the firing pin according to the treatment
suggestion and the prompt, and then restores the normal test.
The sample volume drawn by the sampling needle is 2~70μl, and 0.1μlstepping. The
minimum liquid level detection sample volume is 50μl. During the sampling process, the
minimum test sample size is more than 50μl.
The reagent adding function is used to take quantitative reagent from the reagent bottle,
and fill it into the reaction cuvette. Sampling probe has liquid level detection function. It
System Overview -16
System Overview

can calculate the remaining amount of reagent by the distance the sampling needle
descends, and display the remaining reagent in the [Reagent Information] interface. As
shown in Figure 1-23.

Figure 1-23 Reagent information


In the process of taking reagent, in case of reagent dilution, reagent probe takes reagent in
accordance with the “set quantitative+ allowance” rule and discharge the reagent to the
cuvette according to the “set quantitative. Generally, the set range is 20μl~350μl The
setting unit can be 1μl.
After power on, the sampling needle first rises and swings to the top of the cleaning
position, then drops to the cleaning position to be cleaned and then rises to the top of the
cleaning position.
When performing a sample test, the sampling needle moves in a cycle in the order of
"sample cup (or reagent bottle), reaction cup, and sampling needle cleaning tank".
After the sample test is completed, in the [Maintenance] interface, click [Washing &&
Background] and select the [Add cleaning solution] function, in which you can set the
amount of cleaning solution to be added and the cup number of the reaction cup that needs
to be added.

Click " ", initialization process is the same as the power on process.
During the sampling process, the sampling needle first detects the liquid level and then
continues to descend a certain distance to suck the sample or reagent.
When check movement, click "instrument check" button, as Figure 1-24 shown, R&S tray
and rotating to a certain number. Click the buttons in the figure to check the position of the
sampling needle in the cleaning position, reagent &sample tray and reaction cup.

System Overview -17


System Overview

Figure 1-24 Movement check of sampling probe


1.2.2.3 Sample tube
The sample tube is used to hold the sample, the sample tray an support different types of
sample tube.
The sample area supports the following tube types:
 Microsample cup (microcup): Φ12×37mm, 2ml (Hitachi standard cup)
 Original blood vessels or plastic test tubes: Φ12×68.5mm, Φ12.7×75mm,
Φ13×75mm.
The minimum sample size required for different sizes of sample tubes is also different. The
minimum sample size of each sample tube must be guaranteed, otherwise it may lead to
sampling errors. If the sample size is less than the dead volume, please transfer the sample
to a small sample tube before testing. The minimum sample size of the sample tube is the
sum of the sample size required for the test (the sample size set in the item parameters and
the multi-aspiration of 5μl)and the dead volume of the sample tube.
The dead volume of each sample tube is shown in the following table.
Table 1-2 Sample tube specification and dead volume
Sample container Specification Dead volume
Microsample cup
Φ12×37mm, 2ml 50μl
(microcup)
Φ12×68.5 mm
Original blood vessels Can not higher 8mm
Φ12.7×75 mm
or plastic test tubes than sample.
Φ13×75 mm

1.2.2.4 Reagent bottle


The system supposes 20ml, 50ml and 70ml reagent bottles. The dead volumes of various
reagent bottles are shown in the table below.
Table 1-3 Specification and unavailable volume
Specification Unavailable volume
20ml 0.5ml
50ml 1.5ml
70ml 2.0ml
Please prepare adequate reagents according to the dead volume of the above reagent
bottles before testing to ensure that the test is carried out smoothly.

System Overview -18


System Overview

1.2.2.5 Cooling system


The cooling system uses liquid medium to conduct heat dissipation and refrigeration. The
system consists of reagent tray components, coolant tank, magnetic circulating pump, heat
exchanger, fan, float switch, tubes and so on. The pipeline diagram as shown in figure
1-25.

Heat exchanger Reagent pot

Gas outlet

Coolant inlet

Magnetic circulating pump Coolant tank


Figure 1-25 Cooling system pipeline diagram
1. Cooling components of reagent&sample tray
Cooling components of reagent&sample tray is composed of peltiers, water cooled joint,
fixed film, as shown in figure 1-26.

Reagent&sample tray pot

Incubator

Peltier

Water cooled joint

Fixed film

Figure 1-26 Cooling components of R&S tray


2. Cooling control system

System Overview -19

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