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Full-Automated Biochemistry Analyzer

User Manual
Version: V1.0

MR International Healthcare Technology Co.,Ltd


Content
Preface ...................................................................................................................................1

Product Information ...............................................................................................................2

Copyright and Declaration......................................................................................................3

Product warranty ...................................................................................................................3

Storage conditions during use and transport of the instruments ...........................................4

Reader ....................................................................................................................................5

After Sale Service ...................................................................................................................6

Use of User Manual ................................................................................................................6

Safety instructions..................................................................................................................6

Symbol and meaning: .............................................................................................................6

Safety Precautions..................................................................................................................7

Chapter 1 Installation .................................................................................... 12


1.1 Preparation ................................................................................................................. 12

1.2 Installation .................................................................................................................. 14

1.3 Electromagnetic compatibility requirements ............................................................... 17

Chapter two Introduction .............................................................................. 17


2.1 Work Principals ........................................................................................................... 17

2.2 General introduction ................................................................................................... 17

2.3 Reagent ....................................................................................................................... 20

2.4 Calibrators and quality control material ....................................................................... 23

Chapter 3 Instrument Description ................................................................. 23


3.1 System Structure ......................................................................................................... 23

3.2 Interface basic operation ............................................................................................. 25

Chapter 4 Basic Operation ............................................................................. 28


4.1 Daily Operation4.2 Operation Rule .............................................................................. 28

4.2 Operation Rule ............................................................................................................ 29


Chapter 5 Software Operation ....................................................................... 32
5.1 Software operating environment and configuration requirements............................... 33

5.2 Software installation introduction ............................................................................... 33

5.3 Work menu sheet ........................................................................................................ 33

5.4 Operation menu introduction ...................................................................................... 39

Chapter 6 Maintenance ................................................................................. 78


6.1 Maintenance ............................................................................................................... 78

Chapter 7 Maintenance and troubleshooting ................................................ 80


7.1 Maintenance and usual troubleshooting...................................................................... 80
Preface

First of all,thank you very much for your purchasing HTSH series Full-Automated Biochemistry
Analyzer (hereinafter referred to as Analyzer) manufactured by MR International
Healthcare Technology Co.,Ltd.

Please read the instructions carefully to use the analyzer correctly.


Save the instructions carefully after reading and place the instructions in a convenient location.
To ensure the safe operation of the instrument, please observe the following precautions:

 The contents of this manual include all the optional devices and optional functions (sold
separately). If you have not purchased these optional devices or optional functions, please
skip these contents when reading the manual.
 The analyzer is intended for quantitative analysis of clinical biochemical analysis of bodily
fluids such as serum,plasma, urine, cerebrospinal fluid, pleural effusion, etc. for clinical
and laboratory tests. Other than that, the analyzer may not work properly.
 For clinical testing,use under the supervision of a clinical laboratory technician, hygienic
laboratory technician, or physician.
 Please have received or trained by the designated technical personnel to operate.
 Before using the analyzer,must be familiar with the instructions,analyzer should be used
when instructions are well known.
 Do not use methods not specified in the instructions as it may cause danger and damage
to the analyzer.
 When using the analyzer, monitor the instrument for proper operation by measuring the
quality control. Incorrect measurement results may cause incorrect diagnosis.
 Please refer to the instructions provided by the manufacturer for the methods of storage
(including before and after unsealing),methods of use and precautions of reagents,quality
controls, and standard liquid.
 Units of analyzer couldn't be disassembled or modified without MR's
permission,because it may cause danger to personnel and damage to the instrument.
 Transfer machines,expansion,reorganization,improvement and repair should be conducted
by staff approved by MR.
 The power switch must be easily accessible to safely disconnect the power from the
device and do not place the device in a location where it is difficult to operate the
disconnect device.
 This analyzer is not suitable for home use.
 This analyzer is not suitable for outdoor use.

1
Product Information

Icon Meaning Description

In vitro diagnosis

It is a symbol of EU's unanimous


protection,products therefore complies
CE mark
with the requirements of Directive
98/79/EC.

EU representative

People's Republic of China manufacturing


license for measuring instruments
The serial number of the product shipped
Product Serial Number

Manufacturing date Manufacturing date of product

Maufacturer MR International Healthcare Technology


Co.,Ltd

Advise users to pay attention to potential


dangers and e-waste, they are easy to
pollute the environment.
Warning Contact the manufacturer to recycle or
dispose of these potential sources of
contamination as required by the local
government.

Fragile

Afraid of rain

Up

Stacking layer limit

Temperature range

2
Copyright and Declaration

MR owns the copyright to this non-published "User Manual",and have the right to deal with it
as confidential information. "User Manual" only works as reference materials of analyzer
for use,operation,quality control and calibration, maintenance and repair. Others are not
authorized to disclose the contents of this "User Manual" to others.

"User Manual" includes proprietary information that is protected by copyright laws.All rights
reserved. No part of this manual may be photocopied, photocopied or translated into another
language without the written permission of MR.

MR do not make any kind of guarantee for the "User Manual", including guarantee
responsibility for implied marketability and suitability for a specific purpose.We do not
take responsibility for errors contained in this document or occasional or indirect damage
caused from supply, actual performance and use of the "User Manual".

There may be a slight difference between the display screen described in the User Manual and
the actual display screen,different specifications and models are also slightly different in the
menu and settings.

D ue to product updates, there may be times when the contents of the "User Manual" are
inconsistent with the product, without notice, please understand.

The Company is not responsible for the computer operating system used by users and the
use of the copyright of other companies.

Product warranty

Warranty period

One year from the date of completion of the installation or in accordance with the
contractual agreement.

Guarantee content

MR will be responsible for the safety, reliability and performance of our products if
all of the following requirements are met, namely:
1. Assembly operations, extensions, recalls, improvements and repairs are
carried out by accredited personnel by MR.
2. The relevant electrical equipment complies with national standards.
3. Product operation should be in accordance with the "User Manual".
During the warranty period if fault are caused by MR's design,
manufacturing defects the, will be repaired free of charge,but the repair method will be
determined by MR, according to the content of the fault to take relevant measures.

3
Non-guarantee items (not responsible items)

The following conditions will not be guaranteed even during the warranty period:

1. Failure to use the product outside the operating environment required by this
User Manual.
2. Failure caused by user brutal operation, misuse, misuse.
3. Improper maintenance, or failure due to maintenance by a non-MR
maintenance company.
4. Failure caused when consumables and parts with specified period of use are
not changed when expiry.
5. Failure caused by the use of hardware, software or accessories other than
those supplied by MR.
6. Failure caused from circuit corrosion caused by strong corrosive gas in the
air and obvious aging of optical element.
7. Failure from scrapped analyzer or analyzer purchased from others without
contact with MR.
8. Storage data is lost due to analyzer failure(Suggest users to make timely
data backup or output.)
After installation, using the method not approved by MR to move, transport,
install, lead to breakdown.
Failure to disassemble or modify without permission of MR.
Failures caused by fire, earthquakes, wind damage, floods, lightning strikes and other
irresistible natural disasters.

Storage conditions during use and transport of the


instruments

Installation at the time of purchase is carried out by MR designated installation service


department.
The analyzer must be used if the following conditions are met and the environment is
maintained:

1. Instrument transport conditions:


Ambient temperature: -4℃~40℃ Relative humidity: 30%~80%
Atmospheric pressure: 860hPa~1060hPa
2. Safety conditions use of instrument:
1)Indoor use.
2)Altitude does not exceed 3000m.
3)Temperature 5℃~40℃.
4
4)When the temperature is below 31 ℃, the maximum relative humidity is 80%; When the
temperature is 40 ℃, the relative humidity decreases linearly to 50%.
5)Supply voltage fluctuations do not exceed ± 10% of nominal voltag.
6)Typical transient overvoltage appeared on the grid power supply.
7)Appropriate rated pollution level.
3. Instrument normal working conditions:
1)Indoor use.
2)Rated power supply voltage: ~220V 50Hz.
3)Range of rated power supply voltage:~220V±10% 50Hz±1Hz;
4)Operating temperature:10℃~35℃;
5)Operating relative humidity (extended conditions): ≤90%,No condensation.
6)Storage relative humidity (extended conditions): ≤95%.
7)Altitude is below 3000m;
8)Pollution level: ClassⅡ
4. Other environmental conditions:
1)Low dust, good ventilation
2)Avoid direct sunlight
3)The instrument can be used at room temperature, however, in order to ensure accurate
test results, it is recommended that the room temperature be kept at 10 ° C to 35 ° C,
indoor temperature changes within ± 2 ℃ in the measurement process.
4) The instrument is prohibited to use when humidity greater than 90%, when use the
instrument in an environment of less than 10 °C or above 35 °C.Air-conditioning is
recommended.
5)No detectable vibration.
6)Power supply has no drastic changes.
7)There is no abnormal high frequency machine nearby.
8)There is a separate ground terminal(Ground resistance of 10Ω or less)
9)Data may be effected if the instrument was effected by strong electromagnetic signal,so
keep away from strong electromagnetic fields.
10)The instrument should be stored in: -10 ℃~55 ℃, relative humidity less than 95%, 3000
meters above sea level, non-corrosive gases, well-ventilated, clean indoor.

Reader

Before using the analyzer, please read and understand the contents of this User Manual
carefully so that the system can be used properly.
Readership of the "Manual" for the following laboratory professionals:
1. Daily operator of the analyzer;
2.System maintenance and troubleshooting staff of the analyzer;
3. Personnel who study analyzer operations.

Warnings
● Biochemical analyzers and operating software are limited to be operated by trained
person by and MR or distributors authorized by MR.

5
After Sale Service
Service unit: MR International Healthcare Technology Co.,Ltd.

Use of User Manual


As use guidance of analyzer,the User Manual mainly help users understand the working
principle of automatic biochemical analyzer, structure, methods of operation, routine
maintenance and simple troubleshooting and so on.

Safety instructions
Before use,please carefully read this Safety Instructions and Use Manual to operate correctly.
In order to allow you to use the analyzer safely and correctly, a variety of symbols are used in
the User Manual.
Please fully understand the contents of its statement, then read the text of the manual.

Symbol and meaning:


Symbol Meaning Description

Turn on Turn on the power

Turn off Turn off the power

~ AC power

Warning: Be carefuly,electric
Remind users to avoid electric shock.
shock hazard

Ground terminal

It is used to describe the important information in the


procedure. If you do not follow the instructions, the
Notice
output may be affected or the performance may be
damaged.

Warning: Advise users to pay attention to the potential dangers, if


not follow the instructions may cause human injury, or
Be careful,dangerous the occurrence of damage to the goods.

Indicates the presence of a substance or condition that


Biohazard
is biohazardous.

Indicates useful information during operation of the


Ramark
instrument.

Indicates information we hope you need to know to


Important
ensure instrument performance and to avoid injury.

6
Safety Precautions

For safe use of the analyzer, please read the following safety precautions carefully. Any
operation that violates the following safety precautions could result in system damage and
personal injury.
Warning

● If the user does not follow the instruc ons of MR for use of the analyzer, the protection
provided by the analyzer system may be compromised.

Be careful, dangerous electric shock


To prevent electric shock, observe the following precautions.

Warning

● When the main analyzer power is on, do not open the back cover or side cover with
unauthorized service personnel.
● If liquid enters the analyzer or the instrument leaks, immediately turn off the power, and
contact the after-sales service department of MR or the distributor in your
area. To prevent improper operation of the instrument, it may cause the risk of electric
shock and cause system damage.
● Connect the appropriate output power to prevent other devices (recommended independent
power supply) or cause the analyzer to malfunction.

Prevent personal injury from light source


To prevent personal injury from light sources, please observe the following precautions.

Warning

● When working with the analyzer, do not use your eyes to direct the light emitted by the
light source. These light beams may cause eye damage.
● Before replacing the light source, disconnect the main power of the analyzer and wait
for at least 30 minutes until the light source cools. Do not touch before the light
source cools to avoid burns.

Prevent bodily injury from moving parts


To prevent bodily injury from moving parts while the analyzer is working, observe the following
precautions.

Warning

● When the analyzer is working, do not touch the moving parts of the analyzer mainframe
to avoid bodily injury.
● When working with the Analyzer, do not put your fingers or hands into the open parts.

Biochemical hazard protection


For effective protection against biochemical hazards, observe the following precautions.

Biohazard

7
● Do not touch the sample, mixture and waste directly with your hands. Wear gloves and
workwear when working to prevent contamination, wear safety goggles when
necessary, inadvertently contact with samples cause infection.
● If the sample comes in contact with the skin,please immediately dispose follow the
working standard of the working unit and consult your doctor.
● Some reagents are strongly acidic or strongly basic. Carefully use reagents to prevent
direct contact with hands and clothing. If hands or clothes inadvertently contact with
reagents, immediately wash with soap and water or according to the reagent manual
requirements. If the reagent accidentally enters the eyes, rinse immediately with plenty
of water and consult an ophthalmologist.

Dispose of waste liquid


To prevent environmental pollution and bodily injury caused by the waste, please observe the
following precautions when handling the waste liquid.

Biohazard

● Reagents, quality control solu on, calibra on fluid, intensive cleaning fluid, some
substance of the waste liquid are controlled by pollution regulations and emission
standards. Please comply with the statutory emission standards, and consult the
reagent manufacturer or distributor.

Prevent fire and explosion


To prevent fire and explosion, observe the following precautions.

Warning

● Do not use flammable hazardous materials near the system.

Using Precaution:
To use the analyzer correctly and effectively, please read the following precautions carefully.
Analyzer Usage
Warning

● Analyzer is mainly used for quantitative analysis of serum,plasma,urine,cerebrospinal


fluid,pleural effusion and other fluid samples of clinical biochemical analysis project. If
you need to go beyond this range,please consult with MR.
● When make clinical judgement as per analysis results,please consider the clinical
symptoms or other test results.

Operator
Warning

● The analyzer is limited to operators who have been trained and authorized by MR or
distributors of MR.

Operational Environment

Notice

8
● Please install the instrument according to the specified installed instruction in the
manual. Otherwise, the results may not reliable even may cause system damage.

● Please contact MR if system state is changed.

Prevent electromagnetic waves and noise

Notice
● Keep the instrument away from strong noise source and electromagnetic wave. Turn off
mobile phones and transmitter-receiver when operating the instrument since the
electromagnetic wave may cause an adverse effect on instrument.
● Do not use other medical instrument around the system that may generate
electromagnetic wave interfere with their operations.

Systematic Usage
Notice

● Please operate system follow the "User Manual". Improper use may result in incorrect
measurements and may even result in system damage or personal injury.
● Before using the system for the first time, calibrate it first and then conduct quality
control to confirm that the system is working properly.
● Do not open the sample/reagent disk cover during the analysis.
● The RS-232 interface of the analyzer is set for connection to the RS-232 interface of the
operating unit. Do not connect to any other device's cables. Please use the special
cables provided by MR or distributors to connect the analyzer and operation
department.
● The opera ng part is a computer running opera ng system-specific operating software.
Installation of any hardware or software other than those designated by MR in this
computer may hinder the normal operation of the system. Do not run other
software while the system is working.
● Do not use this computer for other purposes. Improper use may result in system software
infection with computer viruses.

9
System Maintenance

Notice
1) ● Maintaining according to the User Manual. Incorrect maintenance may lead to
wrong result even caused system damage and bodily injury.
2) ● Analyzer placed for a long time, the surface may accumulate dust. When cleaning,
please use a clean, soft cloth soaked in water, gently wipe the surface, if necessary, dip
a small amount of soap solution. Do not use alcoholic organic solvents. After cleaning,
dry it with a dry cloth.
3) ● Before cleaning, please turn off all the power and unplug the power cord; during the
cleaning process, take the necessary measures to prevent water droplets from
entering the system, otherwise it may cause system damage or bodily injury.
4) ●If replace the main analyzer components, such as light source, sample needle,
stirring rod, calibration analysis must be carried out.

Sample

● Use a completely separated serum or plasma sample and urine samples without
suspended matter. If the serum sample contains fibrin, or if the urine sample contains
suspended material, it may clog the sample needle and affect the analysis.
● The presence of drugs, an coagulants, preserva ves, etc. in the sample may interfere with
some of the analytical results.
● Hemolysis, jaundice, chylomicron, etc. in sample may affect the analysis
results,recommended to do a blank sample test.
● Please use the correct sample storage measures. Incorrect sample storage may alter the
sample's component structure and lead to incorrect analysis results.
● Some samples need to be pre-processed for analytical purposes, consult the reagent
manufacturer or distributor.
● The sample size is required when analyzing. When sampling, according to the instructions
of this User Manual to determine the appropriate sample size.
● Before analysis, make sure that the sample is placed in the correct sample posi on,
otherwise you may not get the correct result.

Reagents, Calibration and Control

10
Notice

● When using an analyzer for analysis, you need appropriate reagents, calibra on and
controls.
● Please select the well-matched reagent according to the analyzer. If you are not sure
whether the reagent is available,please consult reagent manufacturers or distributors and
MR or distributors of MR.
● Usage and storage of reagents, calibration, controls observe the instructions for the
manufacturer or distributor of the reagents.
● Improper storage of reagents, calibration and controls can result in failure to obtain the
correct test results and the best system performance, even during the expiration date.
● After replace reagent, please carry out calibration analysis. Without a calibration analysis,
the correct analysis may not be obtained.
● The cross-contamination of reagents may affect the analysis results. For
information,please consult your reagent manufacturer or distributor for relative
information.
Setup of Parameters
Important
● Analyzer needs to set the sample size, reagent volume, measurement wavelength and
other parameters, set these parameters, please follow the " User Manual",and refer to
the instructions provided with reagents.

Data Back Up

Important

● Please backup the analysis data and measurement parameters regularly.

Computer and printer


Notice

● Please refer to the opera ng instruc ons for computer and printer usage notes.

External devices
Warning

● External devices connected to the analyzer, such as computers, are required to meet the
requirements of IEC 60950 or EN 60950.

11
Chapter 1 Installation
1.1 Preparation
The installation of the analyzer can only be performed by the technicians of the MR or
authorized by MR.The user needs to provide the corresponding environment and space.

Warning
● The installation of the analyzer can only be performed by the technicians of the MR or
authorized by MR.

1.1.1 Pre-installation check

Before installation, should carefully check the packaging.If handling damage


should immediately declare to the User Sevice Department of MR or local distributors.
After unpacking, carefully check the appearance of the instrument and the packing list.

1.1.2 Installation requirements

Warning
● The analyzer should be installed where the following conditions are met.
Otherwise,analytical performance can not be guaranteed.

1.1.2.1 Installation environment requirements


For indoor installation only;
Table (or ground) should be flat (less than 1/200 tilt);
Table (or ground) can support at least 50Kg weight;
Ventilation is good; the space is large enough, can not be crowded after installing the
analyzer to ensure operator safety and efficient maintenance space. Do not place the
instrument in a location where it is difficult to disconnect device (such as a power
switch).
Environment as clean as possible;
Avoid direct sunlight;
Avoid placing it near sources of heat and air;
Non-corrosive and flammable gas;
Table (or ground) without shake;
No loud noise source and power supply interference;
Do not touch the brush-type engine and often switch the electrical contact equipment;
Do not get close to devices that emit electromagnetic waves,such as cell phones, radio
transceivers, etc.
1.1.2.2 Power requirements
Power supply: ~220V,50Hz, power 800W, three-core power cord, good grounding.
The analyzer needs a well-grounded electrical outlet to provide the required power.
The distance between the socket and the analyzer is less than 3 meters.

12
Warning
● Power should be properly grounded.Improper grounding may cause electric shock
and damage to the analyzer.
● Make sure the outlet voltage of the power outlet meets the requirements of the
analyzer and that a suitable fuse has been installed.

1.1.2.3 Temperature and humidity requirements


1)Storage temperature and humidity
The analyzer's storage temperature -10℃~55℃, volatility<±2℃/H;
The analyzer's storage humidity ≤95%RH, no condensation.
2)Operating temperature and humidity
When analyzer is working,environment temperature 10℃~35℃,volatility ±2℃/H;
When analyzer is working,environment humidity≤90%RH, no condensation.

Notice
● The analyzer must be operated at the specified ambient and humidity
temperature,otherwise the results may not be reliable.
● If the ambient temperature and humidity outside the above range, air conditioning
equipment should be used.

1.1.2.4 Water supply and drainage requirements


Water quality must meet the GB-6682 three-level water requirements;
Water temperature is 5~50℃;
If water purification equipment is used, the pressure of the water supply must be between
49kPa and 392kPa.

Biohazard
● The effluent from the analyzer should be disposed of according to local emission
standards.

Notice
● Water quality must meet the GB-6682 three-level water requirements; Otherwise,
insufficient water purity may interfere with the test results.

1.1.2.5 Space requirements


The installation and use of the system need to meet the following space requirements.

13
1.2 Installation
1.2.1 Instrument out of the carton
This instrument is a precious precision instrument,especially in transportation and handling
should pay attention to put lightly,can not be inverted; When you receive the
instrument,carefully check the packaging,if you find signs of damage, please contact the after
service or local distributor. After opening the package, check the appearance of the instrument
and check the goods according to the packing list. If you find missing or damaged, please
contact the service or local dealer. After the inspection, by pulling the wheel positioning lock, so
that the four rotating wheels of the device in a movable state, move the equipment to the
preparation place, and then turn the wheel lock positioning lock, so that the four wheels of the
device in the Immovable state,lock the device.

1.2.2 Connect the power cord

On On

Off Off Serial port


Refrigeration Host
Serial port to USB

220V~Voltage-stabilized source
220V~ 50Hz F5AL 250V

14
1.2.3 Connect serial communication line
Connect the computer correctly; Connect the instrument to the computer's RS232 port; Take out
the communication line carried by the computer. One end is connected with the COM serial
communication port of the computer, the other end is connected with the COM serial
communication port of the instrument, and fixed with screws to prevent the communication line
from falling off and causing communication errors.

1.2.4 Connect to the distilled water bucket

Biohazard
● When working,always wear gloves,work clothes in uniforms to prevent infection,
and wear protection goggle when necessary.

Notice
● When placing a distilled water bucket,the top of the bucket can not be higher than
the bottom of the cabinet above the analyzer.
● Make sure that the DI water tubing is clear and free from bending and distortion.

1.2.5 Connect the waste bucket

Biohazard
● When working,always wear gloves,work clothes in uniforms to prevent infection,
and wear protection goggle when necessary.

Notice
● When placing a distilled waste bucket,the top of the bucket can not be higher than
the bottom of the cabinet above the analyzer.
● Make sure that the waste liquid conduit is all above the waste bucket and is clear.
Otherwise, liquid may leak from the analyzer panel due to poor drainage, which
may result in serious damage to the analyzer.

1.2.6 Handling Sample/Reagent Tray

Warning

● Before loading or unloading the sample/reagent tray,make sure the analyzer stops
working or the power is off and the sample/reagent tray is stopped.

Biohazard
● When working,always wear gloves,work clothes in uniforms to prevent infection,
and wear protection goggle when necessary.

15
When loading the sample/reagent tray,hold the handle upright and align the hole on the
sample/reagent tray handwheel with the metal rod on the drive shaft, gently lower and tighten
the screw on the tray so that the sample/reagent tray locked to the drive shaft.
When removing the sample/reagent tray,loosen the screw and hold the handle straight up to
remove it.
Notice
● Sample/reagent bin and sample/reagent tray may be contaminated with sample
during use. When a sample splashes into the sample/reagent bin or on the
sample/reagent tray,wipe it off with a cloth soaked in water or a disinfectant as soon
as possible after turning off the power to the analyzer.

1.2.7 Load and unload the sample tube

Warning
● Before installing or removing the sample tube/cup,confirm the sample/ reagent
tray and the sample needle is stopped.
● Do not use sample containers other than those specified.

When loading the sample tube,insert the tube containing sample into the tube holder until the
bottom of the tube contacts the annular groove of the tube holder.

When removing the sample tube, hold the sample tube by hand and lift it straight up.

1.2.8 Loading and unloading reagent bottle

Warning
●When loading reagent bottles, confirm the sample/ reagent tray and the sample
needle is stopped.
●Do not use reagent bottles other than those specified.

When loading a reagent bottle, insert the reagent bottle containing the reagent into the reagent
bottle receptacle until the bottom of the reagent bottle contacts the bottom of the reagent bottle
receptacle.

When removing the reagent bottle, hold the sample tube by hand and lift it straight up.

1.2.9 Loading and unloading reaction cup

Biohazard
●When working,always wear gloves,work clothes in uniforms to prevent infection,
and wear protection goggle when necessary.
●Abandoned reaction cups should comply with the relevant provisions of the proper
disposal.

Lock the fixed nut on the holder of a row of cuvette,you can load a row of cuvette.

1.2.10 Fuse installation steps

16
Turn off the instrument power, unscrew the back cover of fuse holder with a cross
screwdriver,remove the bad fuse, insert the new fuse of the same model into the back cover of
the fuse,tighten the back cover of fuse holder with a cross screwdriver,the fuse is a designated
type of Ф5×20,T5A L 250V.

Be careful,dangerous
● When replace fuse,you must cut off the power firstly, replace the fuse of the same
specification to prevent electric shock and malfunction.
● There is a danger of electric shock, the replacement of fuses by professionals.

1.3 Electromagnetic compatibility requirements


The analyzer meets the emission and immunity requirements of GB/T 18268.26-2010. The
analyzer are in accordance with GB4824 Class A equipment design and testing. In a home
environment,this analyzer may cause radio interference,require protective measures.

This fully automatic biochemical analyzer should not be used close to or stacked with other
equipment. If it must be used close to or stacked, it should be observed that the verification is
working correctly in the configuration in which it is used. It is forbidden to use this automatic
biochemical analyzer beside the strong radiation source (such as unshielded RF source),
otherwise it may interfere with the normal operation of the equipment.

Chapter two Introduction


2.1 Work Principals
Work principle of analyzer: The substance is qualitatively and quantitatively determined by
measuring the absorbance of light at a specific wavelength or within a certain wavelength range.
When a certain light source emits a bundle of monochromatic light into the liquid under test,
part of the optical signal transmitted through the measured liquid is absorbed, and the other part
is converted into an electrical signal by the solution, after conversion and compute,the amount
absorbed by the substance is proportional to the concentration of the substance and the thickness
of the liquid layer (optical path length), so that the concentration (A) of the substance to be
measured is known.

2.2 General introduction


2.2.1 Accessories and consumables

17
To ensure personal safety and ensure system performance, please use the
parts manufactured or recommended by MR.If necessary,please contact the user
services department of MR or distributor in your area.

Part name Location Remark


Lamp for light
Replace parts regularly.
source
Light box Replace when use more than 3000 hours or the
(20W Halogen
system prompt.
tungsten lamp)
Component of Rocker arm of Replace parts regularly.
samople needle sample needle Replace when use for one year or bend.
Mixing rod Replace parts regularly.
Mixing rod
rocker arm Replace when damaged.
Reaction cup Reaction plate Consumable
40mlReagent
Reagent tray Consumable
bottle

2.2.2 Technical Parameters


Instrument type Fully automatic discrete, random optional mode of work
Specimen type Serum, plasma, urine, cerebrospinal fluid, pleural effusion and so on
System functions 24 hours continuous boot, reagent open, emergency priority testing,
automatic dilution retest
Test speed 240t/h
Items analyzed at the 40 items
same time
Test method Post-spectrometry
Analytical method End point method, fixed time method (two-point method), kinetic
method (rate method),single/dual wavelength method, single/double
reagent, turbidimetric method, immune turbidimetry, multi-standard
method, the detection method is fully open.
Sample tube Micro sample cup, the original blood collection tubes, plastic tubes
and other specifications
Sample tray 50 sample position; All kinds of samples are placed mixedly.
Reagent tray 40 reagent position,24 hours continuous refrigeration,the capacity of
40ml,the system automatically detects reagent bottle margin.
Sample size 2-50ul,0.1µl increments
Reagent volume 10-300ul,1µl increment
Reagents refrigerated 2-8℃,24 hours continuous refrigeration,reagent completely open.
Emergency sample Emergency can be inserted at any time; emergency treatment
processing priority
Sample needles,reagent With liquid level detection function,the system can automatically
needles detect reagent bottle margin; Three-dimensional collision detection
function; With the amount of tracking function, blocking detection,
automatic cleaning function.
Cleaning system Yongquan type deionized water inner and outer wall cleaning,test
cup automatic eight-stage flushing,water consumption is 5
liters/hour,the cuvette is automatically dried,sample needle has
plugging detection and automatic cleaning function.
Cross contamination rate Not more than 0.1%.
Independent mixing Stir immediately after adding the sample(at a same period); For
needle double reagent test, Stir immediately after adding the sample(at a

18
same period).
Reaction tray 80 reaction cup, recyclable.
Reaction temperature 37±0.1˚C,temperature fluctuations should be ± 0.1˚C, With
adjustable thermostat,temperature real-time monitoring display.
Reaction cup 5mm×6mm×25mm,light path 5.0mm,semi-permanent cuvettes made
from 80 micro specialty materials
The total amount of 150~400μl
reaction solution
Minimum reaction test ≤150µl
volume
Optical system Post-spectroscopy
light source 12V, 20VA Halogen Tungsten, Halogen, Iodine Tungsten
Wavelength 340nm,405nm,450nm,510nm,546nm,578nm,620nm,660nm,690nm,
A total of nine wavelengths(open-ended),wavelength precision
0.1nm.
Absorbance range -0.30000-5.0000Abs,resolution 0.0001Abs
Sample dilution/retest The instrument automatically dilutes and re-tests the sample when
the result is outside the linear range or when the sample is
insufficient
Measurement cycle 7.5 seconds
Reaction time 2-15 minutes,optional
Calibration Linear/nonlinear multi-point calibration
Calibration and quality Linear calibration and non-linear calibration,calibration cycles can
control be set automatically and manually,and has a calibration track,
real-time quality control, the day of quality control, day quality
control, out of control processing function
Repeatability Signify with coefficient of variation CV,not more than 1%.
Stability Within 1h,absorbance changes of not more than 0.01.
Items settings Provide any combination of items and optional computing items.
Test setting Single,multiple,combination,batch and contrast settings
Operating system Windows7 and above operating system environment, the English
and Chinese version is optional.
Data processing Can edit more than 300 testing parameters and long-term
storage,instrument can long-term store of more than 200,000 patient
information.
Print A variety of reports printing formats, you can choose.
Pure water machine  Resistivity:18.25 MΩ
(optional)  Conductivity:0.055μs/cm
 Total Organic Carbon (Toc):1-3ppb
 Heavy metal:<0.1 ppb
 Silicate:Soluble silica [calculated as (SiO2):<1ppb
 Pyrogen:<0.02EU/ml
 Microbes:<1CFU/ml
 Debris particles(>0.1μM):(0.1µm)<1/m1
 Water production / flow rate:10L/h
 In line with "Chinese Pharmacopoeia" water for injection 2005
edition,"China Laboratory Water Specifications"
GB6682-92,"Drinking Water Health Standards" GB
5749-85,"Reverse Osmosis Water Treatment Equipment"
GB/T19249-2003.
Power supply 220V ~,50Hz,1KVA three-core power cord,good grounding.
Fuse T5AL 250V

19
Input power 800VA
Storage environment Temperature:-10˚C~55˚C
requirements Humidity:≤95%RH ,no condensation
Atmospheric pressure:50kPa~106kPa
Altitude:below 3000m
Work environment Temperature: 10˚C~ 35˚C
requirements Humidity: ≤90%RH, no condensation.
Atmospheric pressure:70.0kPa~106.0kPa
Altitude: below 3000m
Size 660mm X 450mm X 440mm()
Weight 34Kg
Communication Interface Analysis department and operation department interface:RS-232
Security classification Product Equipment Category: Laboratory

Overvoltage category: Class II


Pollution levels: 2 categories
Environmental conditions:Extended conditions
Equipment Category: Stationary
Connection to the network power: detachable power cord
Operating conditions: continuous operation
Protection grade:IP10

2.3 Reagent
The use of reagents need to refer to the reagent manual,the reagent classification and principles
here will be a brief introduction.

2.3.1 Reagent classification


Reagents can be divided into:
 Dry powder reagents
Dry powder reagent,in using process,need to be diluted by buffer or distilled water(Deionized
water) to dissolve before using the reagent.
 Liquid single reagent
Liquid single reagent refers to those no need any disposal before put in machine, just take it out
of the refrigerator and use it directly,and only need one reagent during use.
 Liquid double (multi) reagent
Liquid double (multi) reagent refers to those no need any disposal before put in machine,just
take it out of the refrigerator and use it directly, but in the process of using two or more reagents
are needed.

2.3.2 Reagents reaction principle

 End point method


(1) Commonly used endpoint reagent
20
Total bilirubin, total bilirubin, total protein, albumin, glucose, uric acid, total cholesterol,
triglyceride, HDL cholesterol, LDL cholesterol, calcium, phosphorus ,magnesium and so on.
The measured substance is completely transformed into products in the reaction process,reach
the end of the reaction,according to the size of the end absorbance to find the measured
concentration,known as the terminal method.
(2) Determination of time of end
①According to the time - absorbance curve to determine,
②According to the measured end of the reaction, combined with the reaction of interfering
substances to determine.
 Fixed-time method: Creatinine, urea, total bile acids using this method
Select two photometry points on the time-absorbance curve. These two points are neither the
initial absorbance nor the end absorbance, and the absorbance difference between these two
points is used in the result compute. Sometimes called this method is two-point method.
 Rate asy
For the determination of enzyme activity,should generally be used continuous monitoring
method,such as alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase,
alkaline phosphatase, gamma glutamyl transferase, amylase, hydroxybutyrate dehydrogenase,
cholinesterase, acid phosphate Enzymes, creatine kinase isozymes and creatine kinase.
Rate asy, in determining the enzyme activity or enzymatic determination of metabolites, the
absorbance value of the linear-phase (absorbance difference between two points is equal) in the
time-absorbance curve is continuously selected, and the change of the unit absorbance value
(ΔA/min) in the linear period is computed for results.

2.3.3 Automatic monitoring of the measurement process


2.3.3.1 Reagent blank monitoring
① Reagent blank absorbance is automatically detected before each bottle of reagent is used
② Reagent blank absorbance should be tested before the samples are tested.Taken by the
analyzer of first reagent after sample.
2.3.3.2 Reagents blank changes rate monitoring
After setting this monitor,the analyzer automatically subtracts the reagent blank rate of change
from the result compute.In assays to measure NAD(P)H reduction as an indicator of enzyme
activity,the blank rate monitors and eliminates the decrease in absorbance caused by NADH's
own oxidation; In the determination of the enzymatic activity of the chromogen as a
substrate,the blank rate monitors and eliminates the increase in absorbance caused by the
breakdown of the substrate itself. The effect of blank rate monitoring on the determination of
creatinine negative interference with bilirubin on the basic picric acid rate assay has been
described above.
2.3.3.3 Sample information monitoring
Due to the sample hemolysis, turbidity, jaundice will reduce non-chemical reaction interference
in results. According to spectral absorption characteristics of hemolysis, lipid cloud,
jaundice,detect its nature and extent with dual wavelength or multi-wavelength,generally test
absorbance ratio of the samples at 600nm/570nm,700nm/660nm and 505nm/480nm to judge
the sample hemolysis,turbidity and jaundice.
2.3.3.4 Results Reliability Monitoring
(1)End point monitoring
(2)Linear period monitoring

21
2.3.3.5 Substrate consumption monitoring
In the continuous monitoring method for the determination of enzyme activity,if the absorbance
rises or falls over its substrate depletion during the monitoring period, the enzyme activity of the
sample is very high,the substrate will be depleted,the absorbance of the monitoring period will
deviate from the linear,make the measurement result unreliable. This monitoring is important for
methods of analyzing enzymatic activity using negative reactions.
2.3.3.6 Method Linear range monitoring
Each test analyte has a measurable concentration or range of activities,if the sample result
exceeds this range, the analyzer will display a prompt that the measured result exceeds the linear
range. Most analyzers will automatically re-measured with the beomg subtracted or incremental.

2.3.4 Single wavelength and dual wavelength


2.3.4.1 Concept
The method of using one wavelength to detect the light absorption intensity of a substance is
referred to as single wavelength method. It can be used when one component is contained in the
reaction solution or when the absorption peak of the component to be measured in the mixed
reaction solution does not overlap with the absorption wavelength of other coexisting
substances.
Using a dominant wavelength and a sub-wavelength called dual-wavelength method. When
there is a large absorption of interfering substances in the reaction solution, which affects the
accuracy of the determination result, it is better to adopt the dual-wavelength method.
2.3.4.2 Effect of dual wavelength
①Eliminate noise interference;
②Reduce stray light effects;
③Reduce the interference of light absorption of the sample itself: If non-chemical interferences
are present in the sample such as triglycerides,hemoglobin,bilirubin, will produce non-specific
light absorption,dual wavelength mode can partially eliminate this type of light absorption
interference.
2.3.4.3 Determinatio method of sub-wavelength
When the main wavelength of the measured object is determined,the subwavelength is chosen
according to the characteristics of the interfering absorption spectrum,to make the interference
at main and sub-wavelength has as same light absorption valueas as possible.
Generally speaking,the sub-wavelength should be greater than the main wavelength of 100nm.

2.3.5 Reagent packaging and use of the period


1)Reagent packaging should pay attention to manufacturer identification,should comply with
the laws and regulations.
2) Reagents should be in line with industry standards or business standards.
3) Reagents should have a suitable shelf life and should be clearly marked.

2.3.6 Precautions for reagents


1) Reagents should be used within the validity period
2) Reagents should be used with the instrument to form a unified system.
3) Reagents should be stored according to the manufacturer's requirements.
4) Reagents should be used accord with the use conditions and the cope of use of manufacturer.
5) Reagents are for in vitro diagnostic use only.

22
2.4 Calibrators and quality control material
2.4.1 Concept

Calibrator: Calibrate with secondary standard material,regular method to fix value. Used for
calibration of conventional methods and instruments.

Control: With characteristics adapt to the detection process, its composition is the same as or
similar to that of the test specimen. Control material should be fully uniform and good
stability,the bottleneck variation must be less than the expected variation in the monitoring
system. Its routine testing helps confirm the scope of the report.

2.4.2 Packaging and use of the period of calibrator and quality

control
1) Packaging of calibrator and quality control should pay attention to manufacturer
identification,should comply with the laws and regulations.
2) Calibration and quality control should have a suitable period of use. And should be clearly
marked

2.4.3 Precautions for calibrators and quality control material


1) Calibration and quality control should be used within the validity period.
2) Calibration and quality control materials should be used in conjunction with the instrument to
form a unified system.
3) Calibrators and controls should be stored according to the manufacturer's requirements.
4) Calibrators and controls should be used under the conditions of use and scope of use required
by the manufacturer.
5) Calibrators and controls are for in vitro diagnostic use only.

Chapter 3 Instrument Description


3.1 System Structure
This chapter mainly introduces the structure of the analyzer,interface,basic operations and so on.
The full name of the product is Full-Automated Biochemistry Analyzer,mainly used for
quantitative analysis of serum, urine and other clinical biochemical items.
The Full-Automated Biochemistry Analyzer is composed of analysis system,operating
system,output system, accessories and consumables.

23
3.1.1 Analysis system

The analysis system mainly consists of sample tray,reagent tray, liquid extraction part,stirring
part,reaction tray,optical and other units,used for analysis.
3.1.1.1 Reagent tray,sample tray
The reagent tray is used for placing the first reagent and the second reagent.
Sample tray is used for placing sample and quality control.
The sample positions can be placed the following sample tube: Micro sample
cup,original blood collection tube.
The number of reagent position of the ananlyzer is up to 40,only can place reagent bottle
of MR.The biggest volume of reagent bottle is 40 ml.
Reagent disc storage has refrigeration,refrigeration temperature 2℃~8℃.
Notice

●According to the number of reagent positons,to determine whether the reagent


positons are placed reagent bottle of MR or universal reagent bottle.

3.1.1.2 Intake system


Intake system mainly includes reagent feeding system, sample feeding system,consists of
sample needle,rocker arm and drive shaft,used to aspirate a specified amount of reagent or
sample from a reagent bottle or sample cup and into a cuvette.
After the feeding action is completed, the reagent needle and the sample needle automatically
move to the designated cleaning position, and wash the inner and outer walls of the needle.
Sample size: 2 ~ 50μl, 0.1μl increment.
The first dose:10 ~ 300μl,1μl increments, the second dose:10 ~ 300μl,1μl increments.
Intake system has liquid level detection function,with the amount of tracking function and
vertical collision protection.

Warning
● Do not place any part of the body on the swing path of the rocker arm or place
any obstacle on the swing path of the rocker arm during operation. Otherwise,
personal injury or system damage may occur.

3.1.1.3. Mixing system


Mixing system is mainly composed of stirring rod, rocker arm and drive shaft, which is used for
mixing the reaction liquid in the cuvette.
In the item test, the cuvette is stirred once after adding the sample and the second reagent to the
cuvette.
After the stirring action is completed, the stirring system automatically moves to the position of
the stirring rod cleaning pool, and the stirring rod is cleaned.

Warning
● Do not place any part of the body on the swing path of the rocker arm or place
any obstacle on the swing path of the rocker arm during operation. Otherwise,
personal injury or system damage may occur.

3.1.1.4. Reaction tray


The reaction tray was used to place cuvettes as a reaction vessel and a colorimetric cuvette.
During the analysis,the specified cuvette is stopped at the sample loading position or the
stirring position for sample loading or stirring, and the colorimetric measurement is
24
performed when passing through the optical axis of the colorimetric optical path.
The cuvette can be recycled.Need to be replaced by hand.
The reaction tray is placed in a temperature-controlled chamber,and the
temperature-controlled chamber provides a constant temperature environment of 37±0.1°C.

3.1.1.5. Optical unit


The optical unit is inside the analyzer chassis and is used to determine the absorbance of the
reaction solution in the cuvette.
The optical unit provides 9 wavelengths, 340nm, 405nm, 450nm, 510nm, 546nm, 578nm,
620nm, 690nm respectively, open ended.

3.1.2 Operating system


The operating system is a computer,which has internal control software for the running,
operation and data processing of the control system.

3.1.3 Output system


The output system is a printer for printing data.

3.2 Interface basic operation


3.2.1 Interface composition
The main interface of software control is as shown.

Software main interface


 Group button area
Located on the left side of the screen, it is used to set parameters, QC management,
maintenance and historical results review. When you click a group button with the left mouse
button, a working page corresponding to this button will appear.

 Work status area


Under the group button area is the working status area, display time, sample ID, sample
cup number and patient information.

 Biochemical testing area


Located on the left and right of the interface for biochemical and emergency testing.

25
 Work page display area
Shows the selected button corresponds to the parameters, processes, results and other
values and graphics. There is a note area below the area.

 The current user display area


Display the current user.

3.2.2 Common interface elements


Dialog box
Dialog box is a common interface to complete human-computer interaction in the system.
The figure below is an example of a dialog box.

Dialog box
Tab
Click the left mouse button on a tab to switch the display area of the working page.The
following figure shows an example of a tab

Drop down box


Click the left mouse button on drop down box ,choose an option. The picture below shows an
example of a drop-down box.

Button
The purpose of the button is to open a dialog box or perform other defined functions. The figure
below is an example of a button. Click the button with the left mouse button to execute the
corresponding operation of this button.

Edit box
The edit box accepts and displays the characters entered by the user through the keyboard. The
picture below shows an example of an edit box.

Scroll bar
If the display exceeds the set size, a scroll bar will appear. The picture below shows an
example of a scroll bar. Move the mouse arrow to the scroll bar, hold down the left mouse
26
button, move the mouse, you can drag the scroll bar to the desired location.

List
The list lists the names of one or more items or combinations of items. The following figure
shows an example of a list of items. Left-click the item, you can select the item; click the item
with the left mouse button again, you can uncheck it.

27
Chapter 4 Basic Operation
4.1 Daily Operation

Check before power

Power on

Start the control

Need to set

Yes
N
Set parameters

Analytical

Need calibration?

Yes
No
Calibrate

Quality control

Sample analysis

Need to edit the sample


results?
Yes
No
Edit the sample

Print sample results

Exit the control

Power off

Check after power

28
4.2 Operation Rule
4.2.1 Analytical preparation
4.2.1.1Check before power on
Before turning on the machine, carry out the following inspection measures to ensure the normal
operation of the system after power-on.
1) Check the power, make sure the power is on and provide the correct voltage.
2) Check the communication cables and power cables between the analyzer, the
computer, and the printer to confirm that they are connected and not loose.
3) Check if the paper is enough. If not enough, add paper.
4) Confirm the cleaning solution has been put away.
5) Confirm that the sample needle is in the normal position (cleaning position).
6) Confirm that the stirring needle is in the normal position (cleaning position).
7) Confirm the deionized water inside the bucket,there should be enough deionized
water.
8) Check if the waste bucket is empty. If not empty, empty the waste bucket.
9) Prepare a sufficient amount of reagent based on the sample size of the day.
4.2.1.2 Power on
After the system is powered on, turn on the power in the following order:
1) Analyzer power
2) Computer monitor power
3) Computer host power
4) Printer power
4.2.1.3 Start the control software
After logging in the Windows operating system, double-click the shortcut icon of the
control software on the desktop or select the control software program from the software
package to start the control software.
After starting,the system will automatically check the operating system, screen
resolution,turn off the screen saver,check the color configuration, initialize the database,
detect the printer.
After checking, the dialog box will pop up, enter the user name and password, click "OK"
button.

29
Notice
● “Admin”。 The system administrator user name is "Admin" and the initial
password of the user name is "Admin".

Notice
● To ensure accurate results, start the analysis test at least half an hour after
powering on.

4.2.1.4 Set parameters

Only correct and reasonable setting of parameters, to be able to carry out biochemical tests and other
operations.
The first time the system is used, you must set the parameters. In daily use, you can set the parameters
as needed.
Before applying for a test, you must set at least the following parameters:
1) Hospital settings.
2) Operator Settings.
3) Calibration fluid settings.
4) Quality control settings.
5) Biochemical project parameters set.

4.2.1.5 Place reagent

Place the appropriate reagent on the reagent position set on the reagent tray and open the reagent
bottle cap.

Warning

● Care should be taken to avoid being scratched by the needle tip.

Biohazard
● Always wear gloves, wear workwear to prevent infection, and wear safety
goggles when necessary.

4.2.2 Testing analysis


4.2.2.1 Calibration
Calibrate before testing,test according to the selection of fllowing figure.

30
Warning
● Changing the batch number of the kit, changing the test parameters, changing the
lamp, and other causes will result in change to assay conditions,need to
re-calibrate.

4.2.2.2 Indoor quality control


The indoor quality control is as a sample interspersed in the sample test. And can be prepared
quality control chart.

4.2.2.3 Sample analysis


Set sample as the figure below. After applying for a sample, place the sample at the position set
on the sample tray.

Notice
● The operation of emergency application is basically the same as the operation of
ordinary sample application.
● Make sure the sample is placed in the correct location.otherwise the correct
analysis may not be obtained.

4.2.3 Results processing


4.2.3.1 Edit sample results

Notice
● Results editors should be under the guidance of a higher level doctor.

4.2.3.2 Print sample results

4.2.4 End the analysis


4.2.4.1 Exit the control software
All tests are completed, the system is in standby mode, you can exit the control software.
4.2.4.2 Power off
31
After exiting the Windows operating system, turn off all parts of the power in the following
order:
1) Printer power
2) Computer power
3) Analyzer power
4.2.4.3 Opertation after powering off
1) Close the lid of each sample/reagent bottle in the sample/reagent tray.
2) Remove the calibration solution,control solution and samples and reagents from
the sample/reagent tray.
3) Empty the waste bucket.
4) Check if there is stains on table-board of analysis part. If yes,wipe off with a
clean,soft cloth.

Chapter 5 Software Operation


In this chapter, the interface and functions are introduced one by one according to the shortcut
buttons and grouping buttons in the control software interface. Please read the instructions carefully
before installation and use.

The software is used with the of biochemical analyzer, carry out customer data,parameter
settings,indoor quality control,biochemical testing, test reports,query statistics,equipment
maintenance and other tasks.
MR provide support and maintenance services for the software.
Wh en the software has a new version, provide users with upgrade services.
In the event of a user interface error, the application program's own logic error,system or network
resource availability error, please shut down the current running software,restart the software before
use;If can not be resolved after restart,please contact after-sales service department or local dealer
of MR.

Warning

●Biochemical analyzers and operating software are limited to those trained and authorized by MR
or distributors of MR.

Data backup

Important

●The analyzer software has the function of automatically storing data on the computer's hard disk.
However, if the hard disk data is deleted or the hard disk is damaged due to other reasons, the data
can not be recovered. Regularly back up data and measurement parameters to other media.

32
5.1 Software operating environment and
configuration requirements
5.1.1 Hardware environment
CPU dual-core 2.1GHz,2G memory,120GB hard drive and above.

5.1.2 Software Environment


Windows 7 English and above.

5.2 Software installation introduction


5.2.1 Installation
Read the software CD,copy,paste, double-click the software executive program.

5.3 Work menu sheet


Work menu Auxiliary menu Function item Purpose
Hospital setting Hospital name Set hospital information.
Hospital address
Contact number
Department and doctor
Settings bar
Save
Delete
Operator Settings Login ID Set operator information.
Operator name
User rights
1.Customer Operator old password
information Operator new password
Save
Delete
Data dictionary Category content You can set some notes
Corresponding entry
settings on the test items.
related information
Save
Delete
Biochemical items Basic parameters Determine the parameter
Reference range
settings values for each item.
Scaling rules
Delete
Save
Preview
Print
2.Parameter Computed items Computed items Items for which test
Expression
settings settings results can be computed
Import
Clear by compute.
Increase
Delete
Save
External items Content input bar For a same specimen,tests
Type of data results from other
settings
Save instruments need to be

33
Delete printed on a same test
report with test reslts of
the analyzer.
Combinations items Combinations items names Set the combination item.
Biochemical combination
settings
iems
New
Save
Delete
Project items order First Set the order of test
Up
setting items,according to the
Down
At last settings, the instrument
Increase automatically operate.
Delete
Save
Linkage detection Items type
Linkage conditions
Save
Delete
Quality control Biochemical items Set the desired test
Quality control target value,
batch number setting control solution
expiration date, batch number,
standard deviation, information.
concentration level
Increase
Save
Delete the item
Increase the lot number
Delete the lot number
Daily quality control Biochemical projects Set the desired quality
Quality control target
control solution
value,expiration date, test
date,lot number, standard information.
deviation, result,test time, Enter the value and
concentration level,QC data information of testing
list,QC chart
Save biochemical fluid.
3.Indoor Delete Automaticly draw quality
quality control control chart.
Month quality Biochemical items Select quality control
Control target,test date, lot
control information, automatic
number,standard
deviation,result,test quality control plot and
time,concentration level, QC list.
data list,QC chart You can preview and
Refresh
Print print QC charts.
Preview
Quality control Concentration level Quality control values
Items
value printing can be previewed and
Batch number
Result printed.
Check the date
Test time
Sort by
Quality control rules

34
Save
Preview
Print
Bulb control Turn on
Turn off
Back
Instrument Instrument initialization Restore the mechanical
parts of the instrument to
initialization Back
the starting point.
Cuvette cleaning Clean all cuvettes The cuvette is washed by
Select cup number to clean selection.
Cuvette check Add distilled water By detecting the water
Evacuate the cuvette
blank, to determine the
Test cup signal
Test cup quality cuvette replacement.
Absorbance Make sure the cuvette is
Signal value zeroed.
Print
Back
Instrument Mechanical arm motion Adjust the position of the
parameter setting
parameter setting moving parts so that they
Cleaning arm movement
parameter settings are in the best position.
Mixing arm set Installation has been set
Working hours set by the installation
Arm reset
Arm up engineer,users don't need
Detection to reset.
4.Instrument Wavelength setting However, when the
Save
maintenance replacement of some
Back
parts or reload a part,
need to re-adjust.
Moving parts Solenoid valve detection bar Detect if moving part is
Pump and syringe detection
inspection in normal condition.
bar
Sensor detection This menu can be used to
Syringe check faults of moving
Bulb control parts.
Stop
Detection
Back
Temperature and Set the maximum temperature Observe and test the
and pressure control and calibration of
pressure
Set the instrument reaction
Back tray temperature and
pressure.
A/D signal detection Wavelength signal display Check the performance of
Graph the grating and the
Refresh performance of the light
Zero source.
Back When you find the
absorbance is low or the
measured value is low,
you can check this menu.
System settings Device communication port

35
selection
Interface color settings
Verification code
Automatic retest setting
LIS communication port
Settings
Select
Back
Shutdown procedure Start
Back
Boot system Absorbance
Signal value
Start
Back
Results query Items The result can be
Test date
corrected by the
Sample ID
Name correction value.
Case number
Result
Unit
Reference range
Test time
Correction value
Amend
Save
Delete
Preview
Print
5.Query
Historical data Test date Displays the test items
statistics Query mode
which are seted test date,
Serial number,sample ID,
medical record number, re-compute and save.
project,test time
Result,
Incubation time
Refresh
Charge statistics Item price setting After settng the project
Statistical methods price, make charging
statistics.
Query Patient information query
display bar
Test results display bar
Query mode selection bar
Inquery
Patient information Test date
Patient information input bar
Sample ID
Save
Delete
Print
6.Test Report
Preview
Scan barcode
Data upload
Results editing Test date
Item type
Project Name,English Name,

36
Result,sample ID
Confirm
Delete
Save
Reaction curve Test date
Item
Result
Test time
Sample ID
Medical record number
Detection method
Refresh
Sample application Test date
Medical record number,
sample ID,cup number,cup
type, sample type
Dilution
New worksheet
ID++
Save&Modify
Copy
Delete
Reagent Amount
Measurement
Work list Test date
Sample ID,medical record
number,cup number,cup
type,sample type
Dilution
New worksheet
ID ++
Save&Modify
Copy
7.Biochemical Delete
Reagent Amount
tests Measurement
Calibration Calibration item selection bar
Dilution
application
New worksheet
ID ++
Save&Modify
Copy
Delete
Reagent Amount
Measurement
Quality control Test date
Sample ID,medical record
application
number,cup number,cup type,
sample type
Dilution
Concentration level
New worksheet
ID++
Save&Modify
Copy
Delete
Reagent Amount

37
Measurement
Sample application Test date
Medical record number,
sample ID,cup number,cup
type, sample type
Dilution
New worksheet
ID++
Save&Modify
Copy
Delete
Reagent Amount
8.Emergency Measurement
testing Work list Test date
Medical record number,
sample ID,cup number,cup
type, sample type
Dilution
New worksheet
ID++
Save&Modify
Copy
Delete
Reagent Amount
Measurement
Sample information Sample ID
Medical record number
Cup number
Cup type
Reagent information Items
Test method
The actual number of samples
Reagent position
Reagent margin
Detectable quantity
Average value
CV value
Reaction cup Sample ID
9.Detection The cuvette position
information
display First reagent position
Incubation time
Absorbance
Standard
Sample position
Items
The second reagent position
Test time
Result
Detect wavelength
information
Image

Warning message
10.Exit Exit the software

38
5.4 Operation menu introduction
5.4.1 Log in
The initial password is "Admin".

5.4.2 Sample
Sample input and detection are under the operation menu of biochemical test.
5.4.2.1Biochemical tests
Click the "Biochemical Test" button on the main menu to enter the biochemical test interface.
There are three sub-items.
1)Biochemical items
As shown in Figure 5.1,enter the sample ID, sample cup number and brief patient information. Select
the items to be tested, click the "Copy" button,if you want to continue to enter,then press "ID ++"
button,the sample ID is automatically increased by 1,select test items,click "Copy". When entering a
sample ID,you can not enter a same number repeatedly,otherwise, the result of the latter sample will
overwrite the result of the previous sample.

Fiture 5.1
If sample value is too large, dilute it with dilution mode and set the dilution factor yourself.
These two lines are the portfolio list,the setting of the combination list is in the parameter menu.

Remark
● In the "Biochemical Items" list, the background color of the item reflects the
current status of the item:
● Blue or blue green indicates that the item is selected;
● Beige means the item is optional;
● The colors in the "Portfolio List" and "Manual Item List" in the Parameters Menu
are also displayed the same as the colors indicated in the biochemical items list.

● Biochemical tests-select items-click to copy

After selecting the test items, click "Copy" in the interface to display the screen shown in
Figure 5.2. Depending on the options,different samples do the same project and the same
sample to do multiple tests.

39
Figure 5.2
Click "Copy" to confirm,click "Back" to cancel.
● Biochemical tests- select items-click Reagent Amount Measurement-pop up reagent detection
dialog box.
Click "Test" to see the screen shown in Figure 5.3.Routine testing,qualit control operations and
calibration operations need to operate the interface,which is the fianl opeartion interface for testing
samples.

Figure 5.3
2)Test items list
As a auxiliary menu of biochemical items menu.Before setting the biochemical items, click on
the inspection work list to see if the current page exists the test items.

Remark
● When the test items of a previous batch are finished and start setting and testing of
a next batch of test items,need to delete the list of test items of the previous
batch,otherwise the test items of a previous batch will be re-tested.

40
Figure 5.4
● Biochemical tests-select biochemical items- click to copy
Interface displayed(Input 10 times,select a same number of sample cup.)

Figure 5.5
● Biochemical Test-Work List-click to delete
Interface displayed

41
Figure 5.6

3)Calibration setting

Figure 5.7
Explanation of interfaces and buttons on interface.
Parameter/ Meaning
function
Sample ID The unique number of each sample,the sample number is unique in a
same day.
Cup # The user can choose where the sample will be placed.
Reaction cup Start to test from any cup number.
Save and After selecting the test items for the sample, click to add to the list of
test items.
Modify

ID++ The sample ID is automatically incremented by 1, allowing you to


enter new sample information.

42
Parameter/ Meaning
function
If n samples do the same project, you can click "Copy" after
Copy
selecting the project and select " Copy Number" to input n.If you
select the "Same Cup Number" means the same sample will made
n times of same item testing.
Delete Use the mouse to select the item to be deleted, make it dark, click
"Delete", you can delete the selected item.
Reagent Insert emergency test samples for priority testing.
Amount
Measurement

5.4.2.2 Emergency test


Emergency testing menu is same as biochemical testing menu,it can insert sample testing in the
ongoing test.Under biochemical testing menu,can not insert samples being tested.
5.4.2.3 Modify the sample test information
Input sample ID to be modified in the "Work List" interface of "Save and Modify", change the
sample's testing information,then click "Save&Modify" (If you have already started testing, you
can not modify).
5.4.2.4 Sample test
1)Sample test interface
After the sample and control inputs are completed in the "Biochemical Test" and "Emergency
Test" menus,click the "Test" button to bring up the biochemical test interface as shown in the figure.

Figure 5.8
2)Sample test interface
In the above interface,click "Test",the test begins. The "Sample,Reagent,Reaction Cup" tab
appears in this interface.Click on each option to see the working status of each element in this
option,
These displayed parameters are set in the "Parameter" setting.

43
Figure 5.9
3) Query the results of the test interface
When the test is finished,the current test result is displayed in the "Sample Test Items List Box"
under "Sample Information".It also display the washing status of reaction tray. In addition,the
current results can also be viewed from the "Query Statistics" function.

Figure 5.10
Different colors represent the various stages of the whole reaction.
If you think the result is questionable and needs to be retested,start with Biochemical Testing.
The following describes the options on this interface..
Option Function
Sample Display the information for each sample
Reagent Reagent information for each reagent position is displayed
Reaction cup Display information for each cuvette
Back After finish the test,click the button to return.

5.4.3 Quality Control


5.4.3.1 Quality control sample input
Sample input under biochemical test interface

44
Click the "Biochemical Test" button,you can enter the biochemical test interface, click "Quality
Control Application",enter the quality control position,that is,"Cup Number", select "Concentration
Level",and then select the biochemical test items can be controlled,click "Save & Modify"
button,select the lot number for each item,then "Save & Modify",click on "Reagent Amount
Measurement"and then "Test". As the picture shows.This interface is used for quality control.

Figure 5.11

Remark
● In the "Item List", the background color of the item reflects the current status of
the item:
● Blue or blue green indicates the item is selected;
● Beige means the item is optional;

5.4.3.2 Quality Control Interface


Click the "Indoor Quality Control" button, enter the quality control interface.

1)Quality control batch number setting


You can set the quality control lot number,target value,expiry date and concentration for each
item. As the picture below.

Figure 5.12

45
2)Quality control data display
In this option you can view the measured quality control values.As the picture shows.

Figure 5.13

In ,if you select "QC Data List," you get the list of QC
values shown above.If you select "QC Chart", a dynamic QC chart will be displayed.

3) Quality Control Chart Analysis


Under this option, you can check the quality control chart for each lot of each item. Similarly, if you
select "QC Data List", you will get a list of QC values shown in the figure below. If you choose
Control Chart,a dynamic control chart is displayed.
The following describes the parameters.
Parameter Meaning

Biochemical item Select the items you want to set and view.
Batch number Batch number of quality control.
QC target value Original target value of QC.
Concentration level Choose high, medium or low.
Expiry date Deadline of effectiveness of QC.
Result Test results of quality control
Standard deviation Select items for using selecting quality control liquid for
standard deviation of quality control.
QC Data List List shows QC results.
QC Chart Chart showing dynamic changes of quality control.

The following describes the button in this interface.


Button Function
Add Add new test items
Save Save data settings,that is, changes made.

46
Button Function
You can delete the items request quality control or content in QC
Delete value list.

Notice
●Correctly set the expiry date of the control solution,so that the system can correctly
judge whether it is valid or not.

5.4.4 Customer information


Click the "Customer Information" button,enter the interface as shown in the figure, mainly for
client unit settings, operator settings and data dictionary settings.

Figure 5.14
The following tabs are introduced one by one.

5.4.4.1 Hospital setting


"Hospital Settings" interface as shown above, used to set the hospital name, address, telephone
number, department name, doctor's name and so on.

The following describes the parameters in this interface.


Parameter Meaning

Hospital name The name of the hospital where the instrument is located, after
input, can be displayed in the report print.
Hospital address The address of the hospital where the instrument is located, after
input, can be displayed in the report print.
Telephone number The telephone of the hospital where the instrument is located,
after input, can be displayed in the report print
Department name Department name where sample was sent.
Doctor's name The name of the doctor the patient is on.
Remark The above parameters are not clear,text need to explain again.
The following describes the button in this interface.
47
Button Function
Save Save the entered information
Delete Delete the input information
5.4.4.2 Operator Settings
Select "Operator Settings" option,enter the following interface:

Figure 5.15
The following describes the parameters in this interface.
Parameter Meaning

Login ID Set the operator's short code to replace the name.


Operator name Set the name of the operator.
User rights Select the operator's authority.
Operator old password The operator sets the previous password.
Operator new password The operator replaces the previous password with the new
password.
Confirm new password Enter the new password again to confirm.
Note:Super User Permissions:Features that the executable software has.

Common User Permission: Biochemical parameter setting, external item parameter setting,
computed item setting and project combination setting in reagent parameter setting can not be
modified; Reference value range setting in reagent parameter setting can not be modified;Can not
modify the other settings of customer information in addition to your own password.

The following describes the button in this interface.


Button Function
Save Save the input information.
Delete Delete the input information.

5.4.4.3 Data dictionary settings


Select "Data Dictionary Settings" option,enter the following interface:

48
Figure 5.16
The following describes the parameters in this interface.
Parameter Meaning
Category content Select the desired content in the category bar.
Corresponding In the corresponding entry bar, the content corresponding to the
entry classified content is displayed.
Related Enter the relevant content in the text box will be displayed in the
information corresponding entry. Here you can increase the sample
type,result unit and reagent bottle model and other classification
content.

The following describes the button in this interface.


Button Function
Save Save your changes.
Delete Delete the selected content.

5.5.5 Instrument maintenance


Click "Instrument Maintenance" button to enter the interface as shown in the figure, which is used to
maintain the system and data.

49
Figure 5.17
5.5.5.1 Communication serial settings
Click on the "System Settings" interface as shown, used to set the system.

Figure 5.18
Enter the password "sages" into the interface, you can choose the instrument model, and set the
communication serial port.

50
Figure 5.19
The following describes the parameters in this interface.
Parameter Meaning

Biochemical analyzer Instrument and computer serial port, usually set by the engineer.
serial port settings
choice
Electrolyte serial port Instrument and computer serial port, usually set by the engineer.
settings choice
mechanical arm Divided into the old mechanical arm and the new mechanical
selection bar arm,usually set by the engineer.

The following describes the button in this interface.


Button Function
Confirm Enter the password and click to enter the dialog box.
Back Click to return to " Maintenance" main page.

5.5.5.2. Motion parameter setting


1) Click the "Instrument Parameter Setting" button,enter the following interface, enter the
password "sages",enter the motor parameters setting dialog box,you can set the mechanical arm's
motion parameters,and the detection of the arm.This step is operated by the engineer.

51
Figure 5.20

Notice
●This step must operated by the engineer,otherwise resulting in unforeseen
failures,at customers' own risk.

2) Input the password,enter the following interface.This interface need change settings only
when initial installation,replacing the mechanical arm and move location.

Figure 5.21

The following describes the parameters in this interface.


Parameters Meaning
Sample tray and reagent Set the parameters for the sample and reagent trays described
tray settings below
Sample tray The number of steps of initial position in the instrument sample
tray.
Reagent tray The number of steps of initial position in the instrument reagent
tray.

52
Parameters Meaning
Sample mechanical arm Set the parameters of the following sample mechanical arm.
setting
Cleaning position With the sample arm in the cleaning position as a starting point.
Cleaning depth The number of steps from the needle of the sample arm to the
depth of the washing position.
Sample position The number of steps of the sample arm needle from the washing
position to the position of the sample cup in the sample tray.
Sample depth The number of steps from the sample arm needle to the depth of
the sample cup in the sample tray.
Reaction cup The number of steps of the sample arm needle from the washing
position to the cuvette position in the reaction tray.
Depth of reaction cup The number of steps from the sample arm needle to the cuvette
depth in the reaction tray.
Reagent arm setting Set the parameters of arm for the following reagent
Cleaning position With the reagent arm in the cleaning position as a starting point.
Cleaning depth The number of steps from the needle of the reagent arm to the
depth of the washing position.
Reagent outer ring The number of steps of the reagent arm needle from washing
position to the position of outer ring of reagent bottle in reagent
tray.
Reagent inner ring The number of steps of the reagent arm needle from washing
position to the position of inner ring of reagent bottle in reagent
tray.
Reagent depth The number of steps from the reagent arm needle to the depth of
the reagent bottle.
Reaction cup The number of steps of the reagent arm needle from the washing
position to the cuvette position in the reaction tray.
Depth of reaction cup The number of steps from the reagent arm needle to the cuvette
depth in the reaction tray.
Mixing arm setting Set the parameters of the following mixing arm.
Cleaning position With the mixing arm in the cleaning position as a starting point.
Cleaning depth The number of steps from the mixing arm to the depth of the
washing position.
Reaction cup The number of steps of the mixing arm from the washing
position to the position of the reaction cup in the reaction tray.
Depth of reaction cup The number of steps from the mixing arm to the depth of the
reaction cup in the reaction tray.
Cleaning arm setting Set the parameters of washing arm.
Depth of reaction cup The number of steps from the washing arm to the cuvette depth
in the reaction tray.
Time setting Set time of the following parameters.

53
Parameters Meaning
Cup blank water level The water level into the reaction cup when the testing cup is
blank,it has been identified by factory.
Cleaning cup water The water level into the reaction cup when wash reaction cup,it
level has been identified by factory.
Cleaning needle time The time required to clean the arm needle. it has been identified
by factory.
Cuvette light path The cuvette's light path,has been determined by the factory.

The following describes the button in this interface.


Button Function

Confirm Enter the password and click to enter the dialog box
Back Click to return to the " Maintenance " Main page
Wavelength Click to pop up the following dialog box, set the wavelength.
setting

Arm up Click to move the mechanical arm up and down in the initial
position.
Arm reset Click to move the mechanical arm left and right and stop in the
initial position.
Test Select a motion parameter setting of the left arm, and click "Test"
to check the correctness of the selected motion of the selected arm.
Save Save the changed settings.

5.5.5.3. Instrument initialization


Click "Instrument Initialization" to get the following dialog box, then click "Instrument
Initialization" to initialize the instrument. This is used when you are unsure that the instrument is
return to the starting point.

Figure 5.22

54
The following describes the button in this interface.
Button Function
Instrument Click to initialize the instrument. Moving parts return back to the
initialization starting position.
Back Click to return to the "Maintenance" main interface.

5.5.5.4. Moving parts inspection


Click "Moving Parts Detection" to get the following interface, which can detect moving parts.

Figure 5.23

Warning
● When working in the system,do not touch the moving parts of the system.These
moving parts include sample needle,mixing arm and washing arm.
● When working in the system, do not put your fingers or hands into the open
parts.

The following describes the parameters in this interface.


Parameter Meaning
Electromagnetic valve
test bar
Needle washing valve Click "Needle Washing Valve",and then click "Test".Testing of Needle
Washing Valve.
Reagent valve Click "Reagent Valve",and then click "Test".Testing of reagent valve.
Watering valve Click "Watering valve",and then click "Test". Testing of watering
valve.
Pump and syringe test
bar
Washing pump Click "Washing Pump",and then click "Test". Testing of washing pump.
Backwater pump Click "Backwater Pump",and then click "Test". Testing of backwater
pump.
Stirring motor Click "Stirring Motor",and then click "Test". Testing of stirring motor.

55
The following describes the button in this interface.
Button Function

Test After selecting the moving parts, click "Test" to check the
movement of the parts.
Stop Moving parts reset.
Back Click to return to the "Maintenance" main interface

5.5.5.5 Cuvette cleaning


Click "Cuvette Cleaning" to enter the following interface,the user can select the cuvette number
to be cleaned, and click "Wash" at the right of "Clean all cuvettes", then clean all the cuvettes.
A total of 80 cuvettes,if click the second "Wash",then you can choose any cuvette between
1-80.

Figure 5.24
The following describes the button in this interface.
Button Function
Clean Clean all cuvettes.
Clean The user chooses the cuvette to be cleaned.
Back Click to return to the "Maintenance" main interface

5.5.5.6 Temperature and Pressure


Click the "Temperature and Pressure" to enter the following interface,the interface mainly
displays temperature and pressure conditions of the reaction tray,if not correct,promptly
improve by temperature calibration parameters setting.

56
Figure 5.25
The following describes the button in this interface.
Button Function
Temperature calibration
parameter setting
Reaction tray calibration Calibrate the temperature of reaction tray
parameters
Set the maximum temperature
and pressure
Upper limit of reaction tray Set the upper limit of reaction tray temperature
Pressure gauge upper limit Set the pressure upper limit of pressure gauge.
Setting Modify the parameter setting to confirm
Back Click to return to the "Maintenance" main interface.

5.5.5.7. Cuvette check


1) Click "Cuvette Check" button,enter the following dialog box. In this dialog, you can
determine whether the cuvette is good or bad by observing the absorbance of the water blank,
and change the cuvette according to the absorbance observation.
2) There are two ways to check the cuvette: absorbance and signal value.
3) After "Fill distilled water",click "Test cup quality",if the individual cuvettes appear red,you
need to detect whether the cuvette is abnormal,at this point,first wash the cuvette again and then
check,if there is red, you have to replace the cuvette,if appear red wavelength,have to contact
the company's after-sales service department
4) "Empty the cuvette" before daily testing,"Fill distilled water"after testing.

57
Figure 5.26
The following describes the button in this interface.
Button Function
Fill distilled water Add distilled water to the cuvette.
Empty the cuvette Evacuate the distilled water in the cuvette.
Test cup quality Click to detect the cuvette is good or bad,if necessary,be replaced.
Back Click to return to the "Maintenance" main interface.

5.5.5.8. A/D signal testing


1) Click "A/D signal testing" button to enter the following interface.In this interface can detect the
stability of each wavelength.
2) If the instrument is moved, the instrument signal value can be determined by the wavelength
fluctuation on this screen.
3) This interface can also observe the linear range of different wavelengths of the instrument.

Figure 5.27

58
The following describes the button in this interface.
Button Function
Refresh Redraw the signal diagram.
Zero Zero the signal value.
Back Click to return to the "Maintenance" main interface.

5.5.6 Query statistics


Click "Query Statistics" button to enter the main interface. As shown below.
1) You can query the historical data under this menu.
2) The history data can be edited under this menu.
3) You can charge and make statistics to test items under this menu.
4) Has a variety of ways to query.
5) Print query and edit results.

Figure 5.28
5.5.6.1. Results correction
1) Click on the "Correction" tab,you can enter the interface,as shown above,for the editing of results
and other operations.
2) Select the item to be modified in the biochemical items bar,select the sample ID number to be
modified in the side column,input the correction value you require,click "Correction" button.
3) Click the "Save" button as shown above to display the revised results.

The following describes the parameters in this interface.


Parameters Meaning

Biochemical items This bar shows all biochemical items,by selecting items to
view and edit.
Items name When selected in the biochemical item,it will be displayed in
the item name.
Testing date Display the biochemical items of the day according to
testing date.
Correction value Use it when editing a item,equivalent to the coefficient.

The following describes the button in this interface.

59
Button Function
Modify Click correction,the items need editing display revised results.
Save The revised results will be saved.
Delete The revised results will be saved.
Preview Preview the test results.
Print Print test results.

5.5.6.2. Historical data display


1) In the historical data, sample results and quality control results of different dates can be displayed.
As shown below.

Figure 5.29
2)The reaction curve of the items results can be displayed.The reaction curve can be edited and
computed.

The following describes the parameters in this interface.


Parameters Meaning

Testing date Only set the test date,can check the test items of the day.
Way of query Two ways of sample query and quality control query.
ID Serial number Shows the serial number of the biochemical items and sample ID
and sample ID number done on the day.Select with the mouse.
Test item After the sample ID number is selected,the test items are
displayed.Selecting by mouse,shows the reaction curve of the test
items.
Results of testing After setting parameters,the test results from the analyzer.
Result Show new results.

The following describes the buttons in this interface.


Button Function
Refresh Click "Refresh" to save the edited result.

5.5.6.3. Charge statistics


Can help the statistics of charges of the test items,click the "Statistics" button to get the total cost.
1) Query statistics-Charge statistics-Patient Charge Statistics(Display after click Statistics button)
60
Figure 5.30

2) Query Statistics-Charge Statistics-Items Charge Statistics(Display after click Statistics button)

Figure 5.31

The following describes the parameters in this interface.


Parameters Meaning

Item price setting According to the items,can enter the required price for testing the
item.
Patient Charge Can display test items of a patient,and the fees charged for these
Statistics items.
Items Charge Charges of a item during date computed.
Statistics
Date computed Query charges statistics as date computed.
Price Enter the price of the selected item in the price bar.

61
The following describes the buttons in this interface.
Button Function
Confirm Confirm the price entered.
Statistics Make statistics on prices.
5.5.6.4 Query
Select the appropriate way of query,click the "Query" button,you can get the test results.
1)Query Statistics-Query-Query as date of testing(Display after click Query button.),as shown
below:

Figure 5.32

2) Query Statistics-Query-Query as doctors conducting testing(Display after click Query button.)

Figure 5.33
The following describes the parameters in this interface.
Parameter Meaning
Query result bar Click the item in the query result bar to display it in the display
column of test results.
Showing bar of Display the results in the query results bar.
test results

62
Parameter Meaning
Doctor You can choose the test results from a doctor.
conducting
testing
Query mode You can choose a way of query in the query way selection bar,by
selection bar date,patient name,Medical record No.,doctor conducting testing or
all the test results and so on.

The following describes the buttons in this interface.


Button Function
Query After selecting "Query Conditions",click this button to search for the
result that meets the conditions.

5.5.6.5. Query as patients name


Patient history data can be displayed for easy analysis of the patient's condition.
Query Statistics-Query as patient's name,as shown below:

Figure 5.34

The following describes the parameters in this interface.


Parameter Meaning
Patient's name Display bar shows the patient's name and other information
List of test items Display the results in the query results column.
Date of testing You can choose the date of testing.

The following describes the buttons in this interface.


Buttons Function
Query After selecting "Query Conditions",click this button to search for the
result that meets the conditions.

5.5.7 Test Report


Click the "Test Report" button to enter the interface,enter the patient details, "Save" the input
information,the user can "Preview" printing format,select the appropriate style,"Print",you can get
the patient's test report.
5.5.7.1 Patient information registration
Generally,input detailed information after testing is finished and before printing the report,click the

63
"Patient Information" button,pop-up "Patient Information Input Bar" dialog box,as shown.This
dialog box is used to display and edit the sample details.

Figure 5.35
In this interface you can also view the patient's test results, and display the measured chart.
The following describes the parameters in the "Sample Information" dialog box.
Parameter Meaning
Sample No. Sample ID
Name Name of patient
Gender Gender of patient
Age Age of patient
Medical record number Medical record number of patient
Hospitalization No. Hospitalization No.of patient
Ward No. The patient's ward number
Department where the The department where the person sent the sample for inspection is.
sample is from.
The person who sent Name of the person who sent the sample for inspection.
the sample for
inspection
Sample type Divided into "serum","plasma","urine","other".
Test physician Operator
Clinical diagnosis Doctor's description of the patient's clinical diagnosis
Barcode Sample barcode information

5.5.7.2 Results editing


Here you can see the patient's test results, and modify.

64
Figure 5.36
5.5.7.3 Reaction curve
1) The inspector can see the test chart here and determine if there is a problem with the instrument or
reagent according to the test chart,and whether the patient's test result is reliable.
2) Inspectors can check the actual measurement chart to see if the reagent parameters are set
correctly. If incorrect, the test points can be changed and reset.

Figure 5.37

5.5.8 Calibration
Click the "biochemical test" button, enter the interface as shown. This interface is mainly used for
biochemical testing and calibration.
5.5.8.1 Determine the calibration item
Firstly select biochemical items,choose the items to be tested,click"Save&Modify" button,in the
work list,select the item to be calibrated,click the "Reagent Amount Measurement",the instrument
will be calibrated before doing biochemical tests.

65
Figure 5.38
5.5.8.2 Calibration fluid settings
Calibration fluid position settings are made in the "Parameter Settings" function.
Click the "Parameters Setting" button,select "Biochemical Items Settings",click on the "Item Basic
Parameters"option,the following interface appears.

Figure 5.39
Select an item in the "Item" list,and then set the standard number and standard liquid position of
items,"Save".When doing the calibration test,the standard solution should be placed in the set
position.If you need to modify the calibration fluid position also through the above steps to change.
A biochemical test can have multiple criteria,enter the number in the standard number,for example
input 3,the following interface appears:

66
Figure 5.40

In the "Standard Liquid Position" edit box fill in the location of each standard solution,and in the
"Standard Value" edit box to fill in the appropriate standard value. Click the drop-down box to the
right of "Calibration Rule" to pop up the calibration formula and select the correct calibration
method:

Figure 5.41

The following describes the parameters in this dialog box.


Parameter Meaning
Standard Input the standard number of the item,which can be multiple.
number
Standard Set the calibration fluid position on the sample plate.
solution
position
Standard The standard value corresponding to calibration solution.
value
Calibration When there is multiple calibration fluids,the computational
formula relationship between every standard values.

67
The following describes the buttons in this dialog box.
Button Function
Save Save the settings you made.

5.5.8.3 Results view


The result after calibration is the standard factor obtained and still be viewed in the "Parameters"
function. The value of "Standard Factor" as the following picture is the results of calibration.

Figure 5.42

Remark
● The system uses the current default calibration factor as a basis for computing the
sample concentration.
● The system will automatically take the current calibration factor (including
calibration factors from calibration test and calibration editor) as the current
default calibration factor.

5.5.9 Biochemical parameters

Click the "Parameter Settings" button,enter the interface as shown in the figure, mainly used for
biochemical test items parameter settings. This is the most important step in using the instrument to
produce the correct result.
Because biochemical testing has many items,in the process of inputing parameters, should set one by
one carefully.
The following tabs are introduced one by one.

Figure 5.43
5.5.9.1 Biochemical items parameters seting

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"Biochemical Items Settings" interface as shown above,used to set the basic parameters of
biochemical test items,reagents and samples,reference range and so on.
1) Basic parameters
Here you can set the test method,main wavelength,sub wavelength,reagent position, reagent bottle
capacity,stirring speed,decimal places and unit.
The setting method can refer to the parameter setting of instruction manual.

Click the drop-down box on the right side of the test method to pop up
this interface to choose the right method.

Click the drop-down box on the right side of the main wavelength to pop
up this interface to choose the correct wavelength.

Click on the right side of the sub-wavelength drop-down box to pop up


this interface, select the correct sub-wavelength..

Click on the right side of the unit drop-down box to pop up this
interface,select the correct unit.

Click the drop-down box on the bottom of the first reagent position,the
second reagent position to pop out this interface,select the correct reagent position.

Click the drop-down box under the capacity to pop-up the interface,select
the correct reagent bottle capacity.

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Click the drop-down box on the bottom of the stirring speed to pop out
this interface,select the correct stirring speed.

The following describes the parameters in this dialog box.


Parameter Meaning
Test method According to the test items,select the appropriate test method through the
drop-down menu.Such as: ALT is the rate method.
Main wavelength Refers to the main wavelength and must be set.
Sub wavelength Refers to the wavelength removed interference,set according to need.
Decimal places Refers to the value of the decimal place that the result should retain Such as:
set "0" means not retain the number behind the decimal places.
Unit Refers to the unit of test item.
Blank absorbance Refers to the maximum blank absorbance value of test items.
Standard solution Set the standard number,and some adopt multiple standard solutions.
number
Standard position During calibration,the place value where the standard solution is placed at the
sample position.
Standard value Marked value of standard solution.

The following describes the buttons in this dialog box.

Button Function
Delete Click to delete the set item.
Save Save the set item.
Preview To preview.
Print To print.

Reagent dosage and sample size

Figure 5.44

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Here, set the dosage and location of the first reagent,the dosage and location of the second
reagent,the respective incubation time and reagent bottle capacity,the sample size,the test time,and
the stirring speed. The following describes the parameters in this dialog box.

Parameter Meaning
The first reagent R1 reagent required amount.The range is 10-300μl,in 0.5μl increments.
Position of the first The location of R1 reagent on reagent position.
reagent
Incubation time Incubation time after adding R1 reagent into sample.
The second reagent R2 reagent required amount. The range is 10-300μl,in 0.5μl increments.
If no need a second reagent,input "0".
Position of the second The location of R2 reagent on reagent position.
reagent
Incubation time Incubation time after adding R2 reagent into sample cup.
Sample size The amount of sample required.The range is 1 to 50μl,in 0.1μl
increments.
Test time The time used to test.
Volume Select the volume of the reagent bottle

2) Reference range
Select a biochemical item,click on the "Reference Range",the reference range of the item
appears,and can be edited.

Figure 5.45

The following describes the parameters in this dialog box.


Parameter Meaning

Gender Gender of patient.


Sample type Type of specimen to be tested. Such as,serum or urine.

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Parameter Meaning
Age Age of patient.
Unit Unit of specimen concentration or activity.
Value of lower The lower limit of normal value.
limit
Value of upper The lower limit of normal value.
limit

The following describes the buttons in this dialog box.


Button Function
Delete Click to delete the set item.
Save Save the set item.
Preview To preview.
Print To print.

3) Calibration rule
If more than one standard is set in "Basic Parameters" and the corresponding calibration method is
selected,the calibration curve is displayed here.

Figure 5.46
The following describes the parameters in this dialog box.
Parameter Meaning

Standard solution position The location of the required standard solution on the sample
position.
Standard value Marked value on standard solution.
Absorbance Absorbance value of the standard solution testing.

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The following describes the buttons in this dialog box.
Button Function
Delete Click to delete the set item.
Save Save the set item.
Preview To preview.
Print To print.

5.5.9.2 External items settings


Click "External Items Settings" to enter the following interface to view or edit other items.
This is primarily for patients who test other results on other instruments and need to print the results
on the same report.

For results, you can choose quantitative or qualitative items.

Figure 5.47
5.5.9.3 Computed Items Settings
Some biochemical items do not need to be tested and can be computed using other test results such
as "Globulin=Total protein-Albumin".

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Figure 5.48
The following describes the parameters in this dialog box.
Parameter Meaning
Chinese name 计算项目的中文名称。
English name English name of the computed item.
Decimal places Decimal places of the saved result of computed item.
Unit Unit of the computed item.
Reference range Normal reference value of computed item.
Expression Computed formula.
Biochemical items In the biochemical item list,select the item related to the
selected computed item and import it.
Clear Click this button to clear the current formula.
Import After selecting the item in the box above the button,click this
button to import the item into the formula.
0~9 Click these buttons to enter figures in the formula.
+ - * / Click these buttons to input add,subtract,multiply and divide
operational symbol.
.( ) Click these buttons to input the decimal point and parentheses
in the formula.

The following describes the buttons in this dialog box.


Button Function
Save Save the set result.
Add Add parameters of patient.
Delete Delete the set result.

5.5.9.4 Combinations items settings


1) Click "Combinations Items Settings" to enter the following interface,where you can edit
combinations items.
2) After click "New" button,input item names need to be combined in the "Combination Item
Name",then click the items to be combined in the items column,click "Save" to display it in the
biochemical combinations items.
3) Biochemical items combination,you can simplify the operation,in the biochemical test,just
click the biochemical items combinations to dispay the items to be tested, see "Biochemical
Testing" specifically.

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Figure 5.49

5.5.9.5 Items Testing Order Setting


1) Here you can set the test order of the items.The left list shows all the biochemical items,and
the right shows the list of available biochemical tests.
2) Select one item on the left and click "Add" to add the item to the bottom of the list on the right.
If you want to set the order of the items in the list on the right, select one and click "Up",
"Down", " Top "and" Last "buttons move," Up "and" Down "buttons move one by one.
3) According to the order set,will start to test from the No.1.

Figure 5.50

5.5.10 Reagent
Reagent is an integral part in biochemical equipment,the quality of reagents directly affect the test
results.
5.5.10.1 Reagent parameter settings
In the "Parameter" setting has been written in detail.

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5.5.10.2 Inquiry of reagent amount

1)When test reagent,click " Reagent Amount Measurement',a dialog box appears,here is a reagent
amount testing column as shown below:

Fiture 5.51
2) Click the Reagent Amount Measurement column, the following figure is shown.

Figure 5.52

3) After the first reagent is selected, the first reagent amount of the set parameters can be viewed in
the display column. After the second reagent is selected, the second reagent amount of the set
parameters can be viewed in the display column.

5.5.11
5.5.11.1
Click "Biochemical Test", then click "Sample Application" to select test items, click "Reagent
Amount Measurement",click "Test" and then click the "Start" in the following picture;
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Figure 5.53
2) The instrument begins to test. As shown below.

Figure 5.54

 The outermost circle on the above chart represents the reaction tray;
 The second ring from outside-to-inside of the above circular disc represents the sample
tray;
 The third ring from outside-to-inside of the above circular disc represents the reagent tray;
The innermost ring of the above circular disc make identify on different states of
reagent,sample and color of reaction process.
When a mouse clicks on a reaction cup in the reaction try of the disk,a information list bar
of the reaction cup appears on the left side of the menu,and the reaction status of the
reaction cup and various parameters information of the reaction are displayed;When the
reagent tray in the disk is clicked,the reagent information list bar will appear on the left of
the menu, and the parameter setting and reaction process of the reagent will be displayed.
When the sample tray in the disk is clicked, the sample information list will appear on the
left side of the menu and display parameter setting and reaction process of the sample.

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5.5.11.2.Emergency testing
The operation is similar as biochemical testing.

5.5.12 Exit
Click the "Exit" button on the main menu,you can exit the entire operating system. There are also
"Exit" buttons in each submenu.If you click the "Exit" button on the submenu,you will be taken
back to the previous menu.

Chapter 6 Maintenance
To ensure the reliability,good working condition and life expectancy of the system
performance,the system should be operated and regularly maintained in strict accordance with the
requirements of this manual.

6.1 Maintenance
6.1 Methods and precautions of correct use and maintenance of
biochemical analyzer:

1) Every morning,firstly let the machine run for 30 minites before testing.

2) Before testing,check if reagent and serum are sufficient.

3) After the daily sample test is completed,the reagents,standard solution and quality control serum
should be stored in the refrigerator in time.

4) Do not touch the arm (moving parts) while the instrument is in testing to prevent accidents.

5) After finishing testing,add distilled water to the cuvette to keep the cuvette wet.

6) Every day,check if distilled water, cleaning solution,and waste bucket are sufficient or spillage.

7) Regularly check if the needle is clogged. Method:Click "Moving Parts Detection" in the
"Instrument Maintenance" menu (Figure 6.1)

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Figure 6.1

Click on "Reagent Valve" and click "Test". If there is no water spray on the sampling needle,apply
acupuncture,if there is no effect,contact us.We will send someone to process it as soon as possible.

8) If it is found that the washing arm can not be drained of water or not poured water into the
cuvette,contact us.

9) If you find the reaction cup scratched surface, affecting the determination of absorbance, should
be promptly replaced.

10) The instrument requires regular testing of the quality control serum to calibrate the instrument
for accuracy.

11) It is recommended that the instrument set the reaction cup at the beginning of the test from Cup
No. 40 because the No. 40 cup has been dried after cleaning.

12) During the use of the instrument,can not frequently switch machines,frequent power will damage
the instrument power supply.

13) If the grid voltage is unstable or the voltage is low, you should use a regulated power supply.

14) Before testing by anallyzer,firstly take reagent out of the refrigerator and await it recover to
room temperature.

15) When the instrument is stationary (without testing), the reagents should be sealed and need to be
opened when testing.

16) The instrument's 3 electronic valves should be regularly checked in the "Moving Parts
Inspection" menu in the "Maintenance" menu. Select "Needle Valve", "Reagent Valve", "Water
Valve" and then "Test" in Figure 6.1 respectively. If you hear a "pop" sound, the electronic valve is
good and contact us if you can not hear the sound.

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17) Select the "Mixing System",click test in Figure 6.1 to check if the paddle is rotating. If the
stirring blade can not rotate,should contact us.

18) Can not strike the "ENTER" and "SPACE" keys of the keyboard while testing,otherwise the
analyzer will directly exit the test.

19) If the cleaning fluid runs out, you can use distilled water instead. Pipette should be placed in a
distilled water bucket.

Chapter 7 Maintenance and


troubleshooting
The following table lists some simple troubleshooting methods. Users can follow the steps below,
if you can not solve, please contact the MR or local dealer.

Maintenance
Notice

● All inspection and repair of the instrument should be responsible by technical staff from or
authorized by MR,the user may not open the case without permission, otherwise
may result in damage to the system or personal injury,at customer's own risk.
● All parts of the instrument are provided by MR or agents authorized by MR,do not use other
parts without permission of MR,or it may cause
system damage or personal injury, at customer's own risk.

7.1 Maintenance and usual troubleshooting

Symptoms Possible cause → Troubleshooting


The instrument can't work or 1. Loose receptacle or unreliable connection→Reconnect and
the power switch is off. secure the receptacle
2. The power cord is loose or unreliable connection→ Reconnect
and secure the power cord
Communication error 1. The serial communication cable is loose or unreliable
connection→ Reconnect and secure the serial communication
cable

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2. Strong electromagnetic interference→Re-plug the serial
communication cable and restart the operating software
Sample needle drip Bubble into the liquid path→Perform instrument infusion in the
maintenance interface.
Cleaning tank overflow 1. Waste collection device is full→Empty the waste collection
device
2. The waste tubing is bent or clogged→Reprocess the waste
tubing and make sure it is free from bending and clogging.
Mean value of reaction cup is 1. The reaction cup is dirty→Perform the cuvette cleaning in the
wrongly checked. maintenance interface
2. The cuvette scratches serious→Replace the new cuvette
Absorbance of reaction cup is 1. The reaction cup is dirty→Perform the cuvette cleaning in the
wrongly checked. maintenance interface.
2. The cuvette scratches is serious→Replace to new cuvette
Detecting abnormal of liquid Ground connection is poor or not grounded → make sure the
level of sample needle. ground is good.
Software abnormality In the event of a user interface error,the application's own logic
error,system or network resource availability error,please shut
down the current running software, restart the software
before use,also could contact with the service department of
MR or your local distributor.

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MR International Healthcare Technology Co.,Ltd.

Address of manufacturer: Unit 83 on 3rd Floor,Yau Lee Center No.45,Hoi Yuen Road,Kwun

Tong Kowloon,HK

Tel:+86-431-81317781 / +86-431-81317079

E-mail:sales@mr-healthcare.com

Website:http://www.mr-healthcare.com

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