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BIOBASE Discrete Automatic Biochemistry Analyzer - Operator Manual

This document is an operation manual for the Biobase Biodustry (Shandong) Co., Ltd Automatic Biochemistry Analyzer. It provides warnings about biohazards, electrical safety, and proper use. It also summarizes the analyzer's components, including its optical system using light absorption measurements, hardware such as its cuvette disk and circuitry, and basic testing principles according to the Lambert-Beer law. The document instructs users to read it carefully before using the analyzer properly.

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0% found this document useful (0 votes)
209 views49 pages

BIOBASE Discrete Automatic Biochemistry Analyzer - Operator Manual

This document is an operation manual for the Biobase Biodustry (Shandong) Co., Ltd Automatic Biochemistry Analyzer. It provides warnings about biohazards, electrical safety, and proper use. It also summarizes the analyzer's components, including its optical system using light absorption measurements, hardware such as its cuvette disk and circuitry, and basic testing principles according to the Lambert-Beer law. The document instructs users to read it carefully before using the analyzer properly.

Uploaded by

SIELAB C.A.
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
Download as pdf or txt
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BIOBASE BIODUSTRY (SHANDONG) CO.

, LTD
BIOBASE Discrete Automatic Biochemistry Analyzer

Operation Manual

Please read this operation manual before using the automatic biochemistry analyzer.
Keep the manual for accessing information.

National Executive Standard: YZB/Lu 0146-2011


Authority Registration Number: Shandong Food and Drug Administration. 2011 No.
2400179.

Jinan Biobase Biotech Co., Ltd.

Biobase Biodustry(Shandong) Co., Ltd.


Biobase Biodustry (Shandong) Co., Ltd
1. Warning label description

Warning: biohazard

Warning: be careful of electric shock

Note: be careful of the danger, it could cause personal injury or equipment


damage

Warning: Be careful of burns

2.Overview
Automatic Biochemistry Analyzer BIOBASE-Crystal is the hospital’s routine in vitro
diagnostic equipment, and it is an instrument. Using in testing a variety of biochemistry
index in the body fluids of patients.

It is necessary to read this chapter carefully before using BIOBASE-Crystal. This


chapter includes important information about using the BIOBASE-Crystal and some
important information of this user manual. Please use the device in accordance with the
provisions of this manual so as to avoid potential personal injury or equipment damage.

2.1 About This Manual


This manual can help the user use BIOBASE-Crystal in a safe and correct way.
For this purpose, the manual will introduce the BIOBASE- Crystal components and
working principle. This manual introduces in a detailed way the necessary software and
hardware knowledge for operating the BIOBASE- Crystal.

After having some knowledge of the components of BIOBASE- Crystal, we will teach
you step by step how to use these modules to complete routine tasks. After reading this
manual thoroughly, I believe you can operate BIOBASE- Crystal well.

We will use some warnings, hints and very useful comments emphasizing the key
chapters, which have a striking "Note" mark.

This manual applies to BIOBASE- Crystal.

Address: No.51 South Gongye Road, Jinan, Shandong, China 250101 1


Biobase Biodustry (Shandong) Co., Ltd
2.2Introduction
The Biosafety automatic biochemistry analyzer BIOBASE- Crystal is optional
automatic biochemistry analyzers of Jinan Biobase Biotech Co., Ltd. These types of
analyzers use 120 discrete cuvettes with a moderate analysis speed, no
cross-contamination, and few consumables, their reagents are opening and other
advantages. Thank you for choosing our products. We will always provide services for
you. If you have any requirements, please notify us. We will do our utmost for you.

Automatic biochemistry analyzer is conventional hospital diagnostic equipment, and it


is an instrument that used in testing a variety of biochemistry index in the body fluids
of patients. Since 1960s when the first biochemistry analyzer was made, it has been
developing by leaps and bounds. Whether from the instrument's accuracy or
manufacturing precision as well as its functions, the analyzers we produced has reached
the level of foreign counterparts. BIOBASE series of discrete automatic biochemistry
analyzers use discrete cuvettes which are segregated and have no cross-contamination
between each other ,which significantly improving the precision and speed of the
instrument, Overcoming the defects such as the relatively low analysis speed of flow
cuvette, serious cross-contamination and low accuracy, so these series of analyzers are
welcomed by the majority of hospitals.

2.3 Users
BIOBASE-CRYSTAL is operated by professional people in accordance with the
manual.

2.4 Security
The following sections will introduce the note in terms of security, electronics and
other relevant potential dangers.

2.5General Prevention
When operating BIOBASE-CRYSTAL, the user should be strictly in compliance with
laboratory practice, and must wear suitable protective clothing and rubber gloves.

During the operation of BIOBASE-CRYSTAL, the sample arm moves quickly, so the
user should not place the hand in the work area of the moving parts so as to avoid
accidental injury. Meanwhile, the user should not rely on BIOBASE-CRYSTAL or tilt
it to avoid potential personal injury or equipment damage.

2.6Electrical Safety Precautions

When disassembling the equipment components or circuit boards, the user should first
turn off the power and disconnect the power.

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Biobase Biodustry (Shandong) Co., Ltd
2.7 Computer Preventive Measures
The computer can not be used for other purposes. The computer should only use the
software for BIOBASE-CRYSTAL by Jinan Biobase Biotech Co., Ltd.

2.8 Processing Machines


Please dispose of the analyzer in accordance with local waste disposal standards.

3. Introduction
3.1 Basic Principles
According to the Lambert - Beer law, when a bunch of incident light shoots through the
colorimetric solution, there is the law concerning the incident light, transmitted light
and the solution of light absorption.

A=-Log10T=KCL
T=I/I0
I0---- Incident light intensity
I----- Transmitted light intensity
A---- Absorbance
C----- Concentration
L----- Optical path
k----- Coefficient

The testing principle of biochemistry analyzer mainly applies light absorption: the
Lambert - Beer law, by measuring the absorbance of the monochromatic light which
shoots through the liquid mixture of the serum or urine and other body fluids and
reagents to determine whether human physiological indicators are normal.

3.2 Hardware
In order to auto-complete specimen test, hardware support is indispensable, which
includes the following aspects:

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Biobase Biodustry (Shandong) Co., Ltd
3.2.1 Optical System
4 4 5 5

1 2 3
8 spectral groups

1. light source 2. fiber guided beam 3. Cuvette 4. Interference filters 5.


Optoelectronic receivers
Figure 1 the optical path diagram

Instrument optical system shown in Figure 1

Light of light source shoots upon the fiber end and then is divided into eight beams
which act as the incident light shooting upon the cuvette. The beams become
monochromatic light after shooting through the solution and go into interference filter
spectrophotometric and then shoot a photoelectric receiver.

We choose the quartz glass halogen lamp of 12V 20W as thr light source, ant the light
source collimates into a parallel beam of 2.5mm diameter. We should use rectangular
discrete plexiglass cuvette of 6mm optical diameter through which UV can shoot
through cuvettes. Cuvettes should be uniform in the shape and there should be no
scratches on the surface of light transmission hole. Light transmittance slot of precise
120 attainment yards disk align at the middle of the cuvette so as to ensure the readings
sampling point is in the middle of the cuvette; 120 cuvettes are placed in a circle of the
reaction plate with the smallest volume of 180ul. The advantage is that there is no cross
contamination. Taking into account the speed of rotating colorimetric turntable, we use
static eight-way splitter system, and integrated components package consisting of
import filters and optical receiver to test wavelength of 340 ,
405,450,510,546,578,630,700 with spectral half width of less than 10nm ± 2nm, so that
we can collect eight wavelength data at once without any mechanical movement, and
overcome the defect that the reaction disk of some of the imported products and the
filter halo also rotate at the same time so as to ensure measurement accuracy.

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Biobase Biodustry (Shandong) Co., Ltd

3.2.2 Circuit
Cuir
pipetting arm control reagent disc control
-cuit
-con
syringe control circuit co
necti RS-232
data acquisition mp
ng
ute
com
colorimetric turntable sample disk control r
-put
sy
er

Figure 2 the circuit diagram

The whole circuit diagram is shown in Figure 2


We adopt an 8051 single chip microcomputer to control the direction, speed, rotation
steps and other functions of a stepper moto and then associated with the computer
through the serial bus connection and then the RS-232 interface. The rotation and lift of
pipetting arm / reagent arm / mixing arm are mainly controled by two stepper motors
and eight position sensors detect the movements and rotational position of sample arm /
the reagents arm / stirring arm; liquid level sensor detects the sample and reagent liquid
level; data acquisition circuit uses eight separate pre-amplifier circuit, respectively, to
enlarge the electrical signals of the photoelectric sensor, the A / D converter converts
analog signals into digital signals; Colorimetric turntable control circuit---stepper motor
controls drive, cuvette.
position sensor, the heating power and temperature control circuit, and regulator power
supply of 12V 20W light, etc.; reagent disk control circuit---stepper motor controls
drive, reagent position sensor and provides two cooler power that ensures reagent
refrigeration and temperature control circuit, etc.; syringe control circuit is driven by
two stepper motors which respectively drive the sample syringe and reagent syringes,,
two position sensors sense the original location of the syringe, and a solenoid valve
controls cleaning and conversion of the sample; sample disk control circuit consists of a
stepper motor and a position sensor. The position sensor is a photoelectric sensor.

The interface circuit consists of two 8051 single chip microcomputers and some
peripheral circuits and is used to the convert the command sent by the computer into
executable command for various moving parts so as to coordinate the work of the
various components; meanwhile it sends the A / D conversed digital signal and
instrument status information to the computer

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Biobase Biodustry (Shandong) Co., Ltd
3.3 Software
User Interface

routine test special test parameter settings data processing maintenance

routine test calibrated quality control tests parameters of tested query of patient’s result routine maintenance

repeated test test of reagent amount item; parameters of QC queries calibrate the instrument

test test of absorbance special item statistical result detect the instrument

print the result

Figure 3. Software structure diagram


The software consists of two parts, namely computer operating software and
single-chip control software; the framework of computer operating software is shown in
Figure 3.

The user interface is formed by Visual Basic development tools in Windows2000


platform and its database is in Access forms. Under the unified user interface , specific
function is accomplished by each sub-module.

Routine testing menu is mainly to complete the daily work and it consists of several
sub- menus: the conventional test is carried out in entry of the day-to-day specimens
information of the patients, in the choice of test items, and in testing samples, and it is
the most commonly used software module of the instrument; emergency test is carried
out in emergency specimens entry and in emergency insertion test of emergency
specimens, priority having been given to some choreographed specimens; real-time
results show that real-time display of test results for each specimen; response curve
display module can display the reaction curve of a sample in any testitem and at any
time so as to easily understand the details of the test; instrument status submenu can
show real-time display of each work status of the instrument; Printing the result means
to verify the detected samples results , print test results reports and give it back to
patients. Thus a complete cycle is completed

The parameter setting menu is to complete the module produced by various parameters
and it consists of two sub-menus: the sub-menu of parameters of tested item mainly sets
the sample volume, reagent volume, the analysis wavelength, test methods and other
parameters of each tested items:; parameter settings of special items is to set a formula,
based on which test results has been calculated and form a new item results;
combinated items settings is to facilitate the item input Based on clinical requirements,
routine testing items can be combined into a new item , and we can enter the new
combinated item name while inputting these items.

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Biobase Biodustry (Shandong) Co., Ltd

Special inspection is the exclusive test in addition to routine test, and it can test the
standard samples, draw standard curves, test quality control specimen, describe quality
control diagram and other work; it can also test the instrument performance, such as
linear measurement, absorbance measurements, the repeatability measurements ,which
has facilitated the identification of the measurement work and special needs of the users;
The layout of each test reagents used in the test means the position of reagents on
turntable is set so that the instrument can accurately find the required reagents.
Instruments can measure the amount of each reagent before the item is tested and tell
the operator whether he needs to add reagents. Maintenance and repair of sub-menu
facilitates maintenance engineers to test various components of the instrument so as to
identify failures.

Data processing module can check the patient's test results, QC results etc,, and carry
out mathematical statistics, calculate daily average, and draw trend mapping to provide
valuable statistical information to the Clinical Laboratory; records of equipment failure
can record the fault information of the instrument while working and provide
maintenance information to maintenance personnel.

Instrument maintenance and maintenance module are to provide staff with a means of
testing instrument. Routine maintenance can provide routine maintenance of the
instrument and calibrating the instrument can test the instrument's moving parts and
optical signal.

SCM software is compiled by using assembly language and is used to manage


coordination operation of each motor of the management, data acquisition and other
work.

3.4 Structure
Biochemistry analyzer consists of the main unit of analyzer, computer (including the
main unit and monitor), the Windows 2000 or more superior operating system,
exclusive software and printers, etc.

It is suggested to buy the computer and printer which meet the national standard.

Minimum configuration: Computer frequency should be no less than 500MHz;


RAM should be greater than 128M;
Hard disk capacity should be greater than 40G;
Monitor should be 15 inches or more in length and resolution should be no
less than 1024 × 768;
The printer should be an ordinary inkjet or laser printer.
The main structure of the biochemistry analyzer:
①Sample parts: The reagent disk, sample disk, sample arm, the reagent arm, diluting
instrument.

Address: No.51 South Gongye Road, Jinan, Shandong, China 250101 7


Biobase Biodustry (Shandong) Co., Ltd
②Testing parts: Optical system, filters, signals acquisition.
③Reaction parts: Reaction disk, constant temperature system

3.5 The Scopes of the Products


This product is suitable for medical and biochemistry analysis test.

3.6 Sample Collection


The sample must be fresh specimens collected in the same day. Serum is centrifuged
samples from the sample as test specimens, and sample should not have the
phenomenon of hemolytic or coagulation.

!! ! Note: The specimens may carry infectious bacteria. Protection is needed when
handling specimens. Operator should wear a mask and put on work clothes to
avoid being infected, and in some cases protective glasses is a necessity.

When handling waste, operator should wear a mask and put on work clothes to
prevent infection, and in some cases protective glasses is a necessity. Please observe
the local emission standards, and consult the reagent manufacturer or distributor.

3.7 Technical Data Sheet


Overall performance:
Model: BIOBASE-CRYSTAL
Type: discrete, fully automatic
Throughput: 300T/H with single reagent
Analysis Method: end-point, fixed-time (two-point),kinetics,turbidimetry
Programming Items: programmable for any test items
Certification: CE, FDA, ISO9001, ISO14001, ISO13485
1. Sample unit:
Sample Settings: 60 sample positions, including calibration, quality control and
emergency, primary tubes and serum is available
Sample Volume: 2ul ~50ul (0.1ul stepping)
Sample Probe: Having liquid level induction function, ensuring the accuracy of adding
sample
Probe cleaning: Automatic washing both interior and exterior
Analysis Items: analyzing maximally 45 items at the same time
2. Reagent unit:
Reagent Position: 45 low-temperature refrigerated reagent position
Reagent Volume: R1:25~300ul, R2:10~150ul (1ul stepping), supporting reagent from
different countries
Temperature Control: continuous 2C~8C cooling within 24 hours
Reagent Probe: Having liquid level induction function, ensuring the accuracy of adding
reagent. Inventory checking
Probe cleaning: Automatic washing both interior and exterior

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Biobase Biodustry (Shandong) Co., Ltd
3. Reaction unit:
Reaction Time: 10 minutes
Cuvettes: 120 independent reaction cuvettes (optical path length 6mm)
Stirrer: after injecting reagent and sample, blending immediately
Cleaning: automatic water cleaning and drying system
Temperature Control: 37C±0.1C
System Adjustment: system can record the blank value and get more accurate result by
deducting blank base value of each cuvette
4. Optical System:
Light Source: 12V/20W halogen-tungsten lamp, 2000 hours
Receiver: 8 imported photo receivers
Wavelength Range: 340,405,450,510,546,578,630,700(three of them can be defined by
users), adopting reversed optics
Testing Wavelength: single and double wavelength test

5. Calibration and QC:


Calibration: one-point, multi-point
Linear Range: 0.000~2.500Abs
Quality Control: Inserting quality control at random.6 quality controls can be reached
with one item
6. Software:
Software: Windows 2000 or Windows XP or above, sample and easy to operate
Emergency Function: emergency sample can be placed in the sample tray at any time
Data Processing: Having reaction curve detection and data display function in the
whole process
Report Printing: report format can be modified by user
7. Others:
Working Temperature: 15C~30C
Humidity: 35%~80%
Power Supply: AC220V+22V 50Hz+1Hz
Dimension: 1020mm×830mm×1200mm (W*D*H)
Weight: 130kg

3.8 Installation Requirements

3.8.1 Installation Environment


1、Indoor installation only;
2、The ground should be flat (inclination should be less than 1/200);
3、BIOBASE-CRYSTAL ground is able to withstand 200kg of weight at least;
4、No direct sunlight in venues;
5、Keep surrounding less dust, less vibration and low noise;
6、Leave the heavy current interference sources;
7、A good ground connection, and grounding resistance is less than 4Ω

Address: No.51 South Gongye Road, Jinan, Shandong, China 250101 9


Biobase Biodustry (Shandong) Co., Ltd
3.8.2Temperature and Humidity
1、 Room temperature should be between 15-30 ℃;
2、 The relative humidity should be no higher than 80%;
3、 The room should be well-ventilated.

3.8.3 Installation Space


102cm 100cm

30cm
switch computer printer
83cm 60cm

Figure 4. Installation space schematic


Main unit: BIOBASE-CRYSTAL: length 1006mm × width 740mm × height 1100mm
!! ! Note: power supply board at the rear of the side of the instrument should not be
blocked off which is to facilitate the operation of the power switch.

3.8.4 Power and Grounding


1. Power supply: AC 220V ± 22V, 50Hz ± 1Hz;
2.Input power: BIOBASE-CRYSTAL: 400W;
3. grounding resistance: <4Ω.

3.8.5 Deionized Water


Less than 5 liters per hour, conductivity is less than 2.0us/cm.

3.9 Transport and Storage Requirements


In the packaging state, analyzer should be transported according to the ordering
contract. Severe impact, rain and exposure should be avoided during transport.
Packaging analyzer should be stored at 0 ° C to 40 ° C with relative humidity no more
than 85%, non-corrosive gases and a well-ventilated environment.

Address: No.51 South Gongye Road, Jinan, Shandong, China 250101 10


Biobase Biodustry (Shandong) Co., Ltd
3.10 Standard Configuration
Unit (There is
no
Serial corresponding
Name Quantity Remarks
number units of
quantity in
English

1 Main unit / 1
2 Manual / 1
Warranty card
3 / 1
Certificate
4 / 1
Accessories box
5
Sample cup
5.1 / 1 Quantity:500
Cuvette
5.2 / 2
Positioning block of
5.3 reagent bottle / 45

Bucket
5.4 / 2
RS232 communication
5.5 cable / 1

Power cord
5.6 / 1
Operating software CD
5.7 / 1
(CD-ROM)
External pipes
5.8 / 1 4mm×6mm
External pipes
5.9 / 1 6.5mm×10mm
Simple tools
5.10 / 1
Spare halogen light
5.11 / 1
Fuse
5.12 / 2
Water falling head
5.13 / 2

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Biobase Biodustry (Shandong) Co., Ltd
5.14 Yellow-green ground / 2
Large joints and nuts of
5.15 large joints / 1

Small joints and nuts of


5.16 small joints / 3

4. Overview of System Operation

4. 1 Introduction of the System


4.1.1 Hardware
1、The main unit
BIOBASE-CRYSTAL automatic biochemistry analyzer is a landing automatic
biochemistry analyzer which adopts stand-cuvette. The instrument is operated without
human intervention during the whole process, and the reagent dial has the function cold
storage.
2、Computer and printer
All operations and control of the instrument are under computer control and it is
connected to the computer interface through RS-232 serial port. The quality of the
computer will directly affect the quality of the system, so the computer must be of good
quality and its conventional configuration should meet the system requirements. To
satisfy the need of installing the system software, the computer must have the
CD-ROM. The computer is a dedicated instrument, not being allowed to do other work,
in particular not being allowed to play games and install other software which is at the
risk of being infected with a virus. The printer is used to print a test report, and a laser
printer is given priority
!! ! Note: The computer not used for any other purposes!
Software:
The instrument is equipped with a set of system software CD-ROM, which is
developed based on the Windows 2000 platform, so the Chinese Windows2000
operating system or the superior system must be installed in the computer.
4.1.2 Installation of the Instrument
1. Unpacking the Instrument
This instrument is a valuable precision instrument. Particular attention should be given
to lightly packaging and releasing and invertion of the instrument is not allowed in the
process of shipping and handling the instrument; it is necessary to firstly check whether
the box is complete or moistened before installing the instrument, if the above situation
happens, it is necessary to notify the staff and they will handle the issue.

The unpackaging steps are as follows:


First remove the panel and side panel of the packaging of the wooden box;
Remove the four screws in the bottom of the backplane; Remove shockproof foam

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Biobase Biodustry (Shandong) Co., Ltd
packaging;

As the instrument is relatively heavy, two or more staff is needed to lift the instrument.
If the instrument is too wide and can not enter the door, the instrument can be tilted
slightly, but can not be inverted; instrument is required to be placed in the level firmly,
and 30cmwith of space at the back of the instrument should be left for maintenance;
Remove the moisture-proof plastic sheeting of the instrument;
Remove the apparatus used for t fixed attachment of the instrument during the transport,
see Figure as follow
Panel and side panel
made of wooden box

Figure 5 Schematic diagram of packaging


Inspect equipment for any abnormal signs, remove the instrument panel to check the
circuit board and whether connector is loose, if it is loose, and please fix it.

2, Instrument installation
Install cleaning bucket;
Install the waste buckets;

Intake Intake

wastewater mouth wastewater mouth

Figure6. Schematic of instrument connecting to the pipes


Rear View
Connected into the water pipes and waste pipes; Install computer and printer;
Connect the power cord and RS-232 serial cable Pour deionized water in a bucket.

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Biobase Biodustry (Shandong) Co., Ltd
ON Fuse Input

OFF
Refrigeration Output
ON
RS-232 RS-232
OFF
Main power

Figure7. Schematic of computer and instruments connecting with RS-232 line

! ! !Note: The parts of the outlet pipe inserting into the waste container should not
be too long, 10 cm in length is appropriate, so as to prevent the excessive
wastewater immersing outlet pipe which will result in poor drainage. !

4.2 Operation Process


4.2.1 Preparation before Turning on the Machine
Prepare cleaning which will use a bucket of 10 liters or more deionized water.
Prepare a variety of test reagents and add them to corresponding reagents kit;
Prepare the samples specimens which will be tested, and add them to the sample cup
and put them on the sample holder;
Check whether the power voltage is normal.
4.2.2 Turning on the Machine
Turn on the power switch (which is located on the right side of the main unit on the
back panel, above which is refrigeration power switch and under which is the main
power switch);

Turn on the computer power switch and the printer power switch, and the main
computer Windows interface appears; double-click the shortcut
"BIOBASE-CRYSTAL" and enter the “log in” interface; enter a user name and
password (the initial user name and password are number "1000"); if they are
confirmed, yon can go to the "BIOBASE-CRYSTAL" main test interface

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Biobase Biodustry (Shandong) Co., Ltd

Please be ready to detect the specimens after the machine has warmed up for 30
minutes.

4. 2. 3 Test the Sample Specimens


The software interface is as follows:

Click “Routine Operation” enter into the following interface

Click “Sample Order "enter into the following interface

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Biobase Biodustry (Shandong) Co., Ltd

4. 2. 4 Enter into the Patient Information and Test Items


Click "Add" button to enter;
Input patient information and specimen information. Combination login is acceptable
(see later chapters);
Select the test item, and click in the name of the test items (press Ctrl to make jumping
options, or press Shift to make consecutive multiple-choice) the item is displayed as
selected, click "=>" (you can double-click to add) to enter them to the column of test
items. You also can select other items, and enter "OK" button to confirm;

Repeat the above steps. When the entry is completed, please exit the routine test login
screen. Click "Testing" to enter the following test interface:

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Biobase Biodustry (Shandong) Co., Ltd

Check reagents and samples in accordance with the place order of the reagents and
samples in the interface. Enter the number of the first cuvette and click the “Start”
button. Hint bar prompts information. After confirmation, please click "OK" button to
start the test;

Instrument starts to test the sample, and the information of the sample is revealed in the
instrument column.
4. 2. 5 Processing and Printing of the Result
In the sample test menu, click “Report”, the following interface appears:

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Biobase Biodustry (Shandong) Co., Ltd

Select the number of samples in Sample ID list box, and the results are displayed in the
results column. If you need patient information, please enter patient information in
patient information column. If you need to print other test results, some other relevant
information can be input to the adding column. The results can also be edited in the
interface;

After the test result is confirmed, please select to print the current report or the whole
report, or choose to print a range of the report;

After finishing the tests, please turn off the system, exit the test interface, and turn off
the computer.

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Biobase Biodustry (Shandong) Co., Ltd
5. Routine Operation

5.1 Flow Chart Turn on the


machine

Warm up for 30 minutes

NO
Calibration

YES
Test Item calibration

QC NO

YES
QC 是

Specimen information entering

Detect specimen

Finish the testing

Result

Printing the result

Turn off the machine

Figure 8 Daily operation flow chart

5.2 Specimen Testing

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Biobase Biodustry (Shandong) Co., Ltd

5.2.1 Preparation for Testing


1. Specimen preparation
Serum samples will be available after centrifuging the tested blood. The serum should
not have clot, hemolysis, and other phenomena. Pour serum or urine to the sample cup,
and there should be no bubbles in the sample cup;
2. Reagent preparation
Add a sufficient amount of reagent in the kit and it is required that within the validity
period, quality of reagents should be stable and reliable;
3. Clean water preparation
Use deionized water with conductivity less than 2.0us/cm;

Click the “Routine Operations” to enter the following test interface:

Click the “Samples Order" menu to enter into the following


interface:

Click "Add" button and Input the information: input the number of samples (sample
number can only have a unique number within a day without repetitive use);

The patient's name, gender, age can be entered in the patient information bar, patient
information can be input while the test report is being printed;

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Biobase Biodustry (Shandong) Co., Ltd
In the Specimen Information Bar, you can edit the sample number. Sample number
conforms to the placement of specimens in the sample circle (the number of location
can be repetitive);

Specimen types: serum, urine and others;

Submission unit: the name of the department which sends specimens;

Patient number: If he is the out-patients, enter patient number; if patients in hospital


enter the hospital number;

Combination login: If you have a number of specimens, , and each specimen will be
tested in terms of the same item, in order to facilitate rapid input , you can place them
continuously on the specimen ring and use the combination login: firstly enter the
starting specimen number, and then enter the start cup No. Finally, enter the quantity of
specimen. Then the number of sample specimens and sample number starting Cup are
continuously choreographed automatically by a computer;

Item selection: You can two input methods----individual item input and item portfolio
input. Portfolio items are defined in later chapters; If you select the individual item, you
can click in the name of the test items (press Ctrl to make jumping options, or press
Shift to make consecutive multiple-choice) the item is displayed as selected, click "=>"
(you can double-click to add) to enter them to the column of test items. You also can
select other items, and enter "OK" button to confirm;

If you select the input of the item portfolio, you can select the name of the item
portfolio to be tested in the item portfolio bar. Click on the item, the item is displayed
as selected, click the "=>" and add it to Selected Item column; if you want to delete a
test item , please click the test item in the Selected Item column, click the" <= " to
delete the test item;

Repeat the above operation to input the specimens; you can edit the information entered.
In the Login Column, you can select a sample number for inquiries and it will reveal
the information of patient and test items. You can use "Edit" or "Delete" button to edit
and delete the displayed content. If the information is correct, please enter “OK” button
for conformation;
Note: The patient information can be entered here and can also be input while
printing a test report;
When the input is completed, please exit the Sample Input interface.
5.2.2 Testing
Click "Testing" to enter into the following interface:

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Check reagent and sample in accordance with the placement order of the reagents and
samples in the interface. Enter the number of the first and last cuvette, click the "Start"
button and pop-up the hint box:

This interface is to remind users to check whether the reaction cup is washed clean and
whether the number of selected initial and last reaction cup is correct;

After confirmation, please click "OK (the first one)", the instrument begins test; if you
cancel the above input, please click the "Cancel (the second one)";

If you want to suspend operations in the testing process, please press the "Pause" button
(Note: pause time in the testing process can not be too long) If you want to continue the
test, please press the "Continue", the instruments will continue to test. If you want to
cease the operation you can click the “Stop” button to cancel all tests and retreat to the
main interface;

After confirmation, please click "OK". The status bar will have real-time display of the
sample state in order to observe the work of the instrument;

When the instrument is to show the test results show, it will have real-time display of

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test results, absorbance, and other information in the results column. There will be a
new test results about every 18 seconds. If a picture can not show all test results, the
vertical scroll bar on the right side of the interface can be scrolled to show all the test
data.
5.3 Testing the Emergency Specimens
In the process of testing specimens, emergency specimens can be inserted at any time;

Put the specimens on the sample ring (specimens can be placed on any vacancy in the
sample circle. Action: should be quick, do not place while the sample circle is still
rotating);
Click "Sample Order" menu interface is as follows:

Emergency interface and routine test interface is roughly the same, and the difference is
that when entering the emergency sample, one should select the emergency check box”
Stat” (see above).The other input is the same with a common sample. After the input is
completed and the current sample is finished, the instrument will test emergency
specimens.
5.4 Repeat-test Sample Inputting
If the item of some specimens was found too high in concentration or other bad results,
you can re-test it. The test results will overwrite the original data. We can enter the
“Repeat Test”, and the interface is as follows:

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Click”Edit”, Select the number of specimen which will be retested, edit it. Select the
items which will be retested and add them to the selected item. Repeat the above
process multiple input samples. Make sure click the” Repeat Test” check box .Click
“OK” to enter the test interface for test.
5.5 Registration and Printing of the Results
Click “Report" to enter the following interface:

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The specimen test results of the day can all be found in the results sample box. First,
select the number of samples, and test results are displayed in the results column; If it is
needed to enter patient information, please enter the patient information in patient
information column; If need to print other test results in the report, you can also add
item name in addition column and enter data in the results column; If you want to edit
the test results, move the cursor to results column in which the results are needed to be
replaced. Enter the new results and confirm.

If all the samples have not been tested, and you want to print part of the results report
(release the report while testing the sample), you have to click the button of “Calculate”.
Once the specimen is tested, the calculation results will appear immediately; otherwise
the calculation results will appear after all the tests end.

If there is the "√" mark in “Print Order” box, it means the printing order of the data
conforms to the setting of date printing order described by the user in data maintenance
(printing order maintenance is defined in "Data Management" of "Data Maintenance" ).

After confirming test result, please select “All” “Current” or “Range” of report for
printing.

The report format is as follows:

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××××××test report
Item NO.:0764
NAME:______ SEX___ AGE___ No ITEM RESULT 单
1 ALT 13.00 U/L 0.00—45.00 9 TG 1.46 mmol/l 0.48—1.88
2 AST 25.00 U/L 0.00—45.00 10 Crea 70.0 umol/l 36.0—144.0
3 AKP 83.00 U/L 15.0—150.0
4 TBIL 16.80 umol/l 6.0—22.0
5 IBIL 6.00 umol/l 0.00—6.0
6 TP 74.50 g/L 60.0—85.0
7 ALB 48.4 g/L 35.0—55.0
8 A/G 1.9 1.00—2.00

DATE:200*/*/*

Figure 9 print reports diagram

6.1 Parameter Settings of the Tested Item


When need to test for new items or input new reagents, must first carries on the item
parameters Settings

!! !! Note: In order to prevent the phenomenon of changing the item parameters


casually, password is set. If you do not enter a password, you can only edit item
parameters that are not closed in the parameter setting bar. If you want to edit the
closed item parameters, you must enter the correct password. The original
password is "00000000". You can also modify the original password by entering
the password changing field to change passwords. Please keep in mind the
modified password.

When inputting a new test item or replace reagents, one needs to change test parameters.
Parameter setting process is as follows:

Click the “Parameter” menu of "Item parameters" in the main interface and enter the
following

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Click the item name in the item column, such as "ALT", the background of the item
turns blue. At this point, item number, English name, item name, Chinese name, the test
item parameters and other information of the tested item are revealed.

Sample parameters: “Sample volume”, “R1 volume” o, “R2 volume”. These data will
limit the volume of solution extracted by sample syringe, reagent syringe; “Sample
volume” range is between 2-50ul, “R1 volume” range is between 25 -300μl, “R2
volume” range is between 10-150ul. If you do not set the second reagent, you can enter
"0" or not input anything in the “R2 volume”.

The test parameters are as follows:

The dominant testing wavelength:


Select among 340,405,450,510,546,578,630,700;

The Auxiliary testing wavelength:


Select among 0,340,405,450,510,546,578,630,700.

If you do not set dual wavelength, select 0 of the second wavelength;

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Test method: the end-point method, the two-point method, dynamic method,
turbidimetry, select according to the test reagents and methods; typical reaction curves
are as follows.

OD OD
2.0 2.0

1.0 1.0

0.0 0.0
0 10 20 30 40 50 0 10 20 30 40 50

Figure 10. Endpoint method response curve diagram Figure 11 dynamic method reaction
curve diagram

Slope: If the absorbance readings are becoming bigger, that is a positive slope.
If the absorbance readings are becoming smaller, that is a negative lope
Maximum slope: it represents the maximum allowable amount of absorbance change. If
it is larger than the set value, indicating that there is error the sample which is being
analyzed. Instrument gives failure code, suggesting that the specimen need to be
retested
Reading point: the main reading segment is beginning time of reading and the period of
reading time;
There are 40 points of the instrument in the whole process of reading, interval of each
point is about 18 seconds, and the entire reading time is 40 × 18 = 720 seconds (12
minutes).
If you choose the third minutes as the starting point, the reading interval is three
minutes. Then the starting value is 10, the end value is 20.

If you need to adopt the blank sample method during the test, you should read blank
sample while reading. You should apply the method of Sec readings, meaning reading
the blank sample data in the auxiliary reading section, read the response data in the
main reading section, and process data according to the need. Auxiliary reading section
is located before main reading section.
Please set the data according to the need.

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OD Second reagent

1.5

1.0
Secondary Readings section Primary reading section
0.5

0 5 10 15 20 25 30 35 40 45

Figure12. Auxiliary reading segment diagram


Normal range: it refers to the normal range of the test results, the instrument will
prompt in the test results when surpassing this normal range.

Linear correlation: If the machine's test results are different from expectations, you can
be modify the result according to the formula Y = AX + B, change the coefficient A
and B to amend the test results.
Unit: Concentration units can be selected in the drop-down list.
Accuracy: the number of decimal places of the test results can be selected in the
drop-down list.

Maximum rate of change (A / min): It refers to the maximum absorbance change. In


particular when controlling enzymatic measurement, due to the high concentration,
reaction is violent, change of absorbance is rapid so substrate is depleted and false
results; if this happens, the instrument will prompt re-test the specimen.

If you want to modify the item parameters, select the item in the list of items column,
click "Edit" button, and then the cursor can be moved to necessary parts to modify, if
one wants to cancel the change; click "Delete" button. If you want to save your changes,
then click the "Ok" button.

If you want to delete test item parameters, select the item in the list of items column,
click the "Delete" button, and then remove the item parameters.
If you want to add the test item, click the "Add" button to enter the test parameters, and
save the input.

6.2 Parameter Settings of Special Items

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Click the “Parameters” and then click" Specific Parameters "see the following
interface:

6.3 Parameter Settings of combination item


Click the "Add" button in the column of portfolio Order, enter the Number, Item Name,
Full Name, and the Item Name must be entered. Click the items in the Item list and the
background color of the item turns blue, click the "=>" button to add items to the Item
list. Use the same method to select other items. If you want to delete the selected item
in the list, first click the item, then click the "<=" button, the item disappears from the
Item list. After all of the items are selected, click "OK" button, the setting of items
portfolio is completed;

You can edit the items portfolio with the help of "Delete" button and "Edit" button.
6.4 Parameter Settings of Items for Calculation
Please click the "Add" button in the column of Calculated Items. Please enter Number,
Item Name, Full Name, Item Name, and the Item Name must be entered. Enter the
value in Low, High, and Decimal. If during specimen test, all the test items contained in
the Formula. After the test is completed, the value of items for calculation will be
automatically calculated and results will be printed.

When edit the Formula, you can directly enter the item name (item must be in the Item
List), or select an item in the optional item column. There can be only the item name
and calculation symbols in the Formula. No other non-standard symbols are allowed.
Please click "OK" button after setting the item.

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You can edit the item for calculation with the help of button "Delete" and "Edit"

!!! After deleting one item, you must also delete this item in Print item order
(“Data Management”, “Data Maintenance”), otherwise will have mistakes.

6.5Parameter Settings of the Input Item


Please click the "Add" button in the Input Items. Please input Number, Item Name,
Units, Full Name, and the Item Name must be entered. And enter the value of Low,
High, and Decimal. Please click "OK" button after input all the items.

You can edit the item for calculation with the help of button "Delete" and "Edit"

Note: Input item in the “Report” must be maintained in this column. If there is no
item in this column, the entered data can not be printed.

7 Specific Tests
7.1 Calibration and QC
Some test items need calibration.
Click the “special test” and choose “Calibration And QC” to display the following
Interface:

In Mode, select the “Calibration”.

Calibration item parameter needs to be done before calibration procedure, click


"Calibration Parameter" button to display the following interface.

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Click the “Item List” to list the item parameter in the screen

Item name and test parameter shows the same. The calibration mode can have a variety
of options.
Calibration mode: Calibration Type for CRYSTAL
1、 One Point
2、 Two Point
3、 Multi-Point 1 (passing the zero point)
4、 Multi-Point 2(without passing the zero point)
Formula: the formula is as follows:
1、 Y=AX
2、 Y=AX+B
3、 Y=A0X^n+A1X^(n-1)+……..+AnX
4、 Y=A0X^n+A1X^(n-1)+……..+AnX+B

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Concentration Concentration
40.0 40.0

20.0 20.0
0.00 0.00
0.4 0.8 1.2 1.6 1.8 OD 0.4 0.8 1.2 1.6 1.8 OD

Figure13.Calibration curve of a single standard Figure14.Calibration curve of doubles


tandard

Concentration Concentration
40.0 40.0

20.0 20.0
0.00 0.00
0.4 0.8 1.2 1.6 1.8 OD 0.4 0.8 1.2 1.6 1.8 OD

Figure 15.Calibration curve of multi-standard (through zero point) Figure


16.Calibration curve of multi-standard (not through zero point)

! ! ! Usually use “One Point” is enough.


“Repeat Counts”: Repeat the test several times; the result is the average one of the
result
Standard Counts: place several Standardized ones at once, One item can have 6
standardized ones, Multi-point calibration is allowed.

Sample Type: Serum.

Reagent blank absorbance (sample): reagents (samples) and blank absorbance value,
this data is automatically measured in instrument calibration testing process (it needs
not to be input).

Blank Category: reagent blank and sample blank value. If you choose reagent blank,
you can get the final absorbance test value by deducting in the test the he reagent blank
of total absorbance. If you choose sample blank, firstly test sample blank in each
sample test, and then test the reactant absorbance, the absorbance of the reactants minus
sample blank absorbance will get the final absorbance data.

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Standard: When have multiple standards, each standard should have its unique number.

Lot: input batch number of standard material.


Abs: when calibration, the instrument measures absorbance values of standard material
.
Factor: the instrument calculates the coefficients according to the concentration of
standard material, the absorbance value, reagent blank and calibration formula.

Conc Volume: input the concentration of standard material.


Cup: when calibrating, standard material should be placed on the location of the sample
circle.

The graphic box showed the calibration curve after calibration, the horizontal axis is the
absorbance OD value and the vertical axis is the concentration value.

Change the scale of the abscissa scale; you can change the horizontal aspect ratio.
Change the scale of the ordinate scale can change the horizontal aspect ratio.

Current Data: select accredited calibration results in date list of all calibration and
display it in the text box. If you want to delete a calibration data in the list, you can
select the data; click “Delete” button.

If you want to modify the calibration parameters, please press "Change" button,.

If the calibration results are right, you can click the "OK" button to save the calibration
results.

Click the "Exit" button, and returned to “Calibration And QC” interface.

Select the calibration item in the Item Lists column, method of selection is the same as
that described earlier.

If the data is entered correctly, click the "Start" button, the calibration test begins.

In the test process, you can click the "Stop" button, to stop the test.

After the test is completed, you can click the “Calibration Parameter” to see results of
the calibration.

7.2 QC Test
In order to monitor the accuracy of test results, it is sometimes necessary to test quality
control of some specimens. There are a variety of ways of doing QC test, the first
method is in ordinary sample test, you can observe whether the test results is within the
quality control range, the second method is to enter the “quality control test” interface

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to do quality control test.

Select the quality control mode in Mode;

Please firstly set the quality control parameters before doing quality control, click “QC
Parameter" button to display the interface above;
Click the “Add” button:
Enter the QC Lot:
Select test items in Item column, add it to the "QC Item" column, steps are the same as
describe above;

In the "QC Item" column, click an item and enter the Mean Standard Deviation and QC
Lot, repeat the above steps, you can enter quality control data for each item;

Press the "Delete" and "Edit" button to edit the input values;

Click the "OK" button to save the data;


Withdraw from the interface, and return to the “Calibration And QC” interface;

In "QC" column, press "Add" button to enter QC Order No, QC Cup No. (Indicating
the quality control specimens were placed in the placing number of sample disk) and
QC Lot. In “Items Lists" column, select an item and add it to “Items" column; Repeat
the above steps and enter multiple quality control specimens. Use "Edit" and "Delete"
button to modify the input data; entry information can be shown in the QC Order List;

If the data is entered correctly, click the "Start" button, the quality control test begins;

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In the test process, you can click the "Stop" button to stop the test;
The test results are shown in real time in the results column, and the results are stored
in the QC database.

7.3 Use Calibration+ QC at the Same Time


If the calibration and quality control are tested at the same time, select "Calibration +
QC" mode in " Mode" column, and other inputs are same as that described above, After
entering calibration and quality control data , please start test.

7.4 Regents
The instrument has a reagent disk in which 45 reagent boxes can be placed; order of
reagents shall be set in the “Reagent Status” interface. The interface can estimate how
many tests can the remaining reagents in the reagent boxes can do so as to avoid the
situation that reagent is in shortage in the test process.

On the main interface, click the "Reagent Status" menu under the "Specific Test" menu
to appear the following interface:

In this interface, you can enter the information of the reagent;

No.: reagent box is placed on corresponding location of number in the reagent disk
(range: No.1-No.45);

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Item: are selected in the drop-down list of the input box;

Amounts: maximum volume of reagent box (ml); The height of the reagent box: net
height of the reagent box (mm);

R1 or R2: place the first reagent or the second reagent;

If you want to test the remaining reagent volume, click the "Start" button, the
instrument automatically detects the reagent stock and calculates the number of items
that can be tested.

!! ! NOTE: The reagents location can not be misplaced, before the testing, please
make sure there is sufficient reagent for testing items.

7.5 Instrument Performance Test


For the needs of Instrument performance test and the calculation, we should test
absorbance of some standard solution. Enter this program module, absorbance test and
Instruments stability can be carried out.

In the main interface, click the "Reading Absorbance” under “Specific Test" menu to
enter the above interface.

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Click “Stability Test”:


Select Wavelength (eight wavelengths for choice), input the number of cuvette for
testing, and select Time for reading (Maximum 60 min)
After the data is entered correctly, click the button "Start" to test.
When starting, every 12 seconds to refresh the data, every 5 minutes to a records, until
the set time interval. Observation data changes, and determine the stability of the
instrument;

Click “Reading Abs” to enter the following interface.

Select the desired wavelength in Wavelength drop-down list, after sample in cuvette is
ready, click the button "Start", and the instrument begins reading; After the reading is
completed, the table shows the number of the cuvette and corresponding absorbance
values, select the number of the cuvette to find the corresponding measured absorbance
value.
!!!Note: In the process of the instrument performance tests, make sure 120 cuvette
was added deionized water as water blank.

8. Data Management

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The Data Management consists of four sub-menus: Query, Adjust results, Reaction
Curves and Data Maintenance for data query processing.
8.1 Query
The query has two sub-menus: Results Query and QC Query

8.1.1 Results Query


In the data processing interfaces, click the "Data Management - Query, click the"
Results Query” menu, the following interface appear:

Queries can be carried out by a variety of ways, such as Date, Name, Department, and
Patient ID. There are three kinds of query: Date, Name and Sample No. If according to
the Date, select the correct date, confirm the registration number of the day to display in
the Sample No. column, select the appropriate number of samples, the results are
displayed in the results column, click the button "Print", then print a report. Also can
use a combination of query, enter a few queries, such as at the same time to enter the
date and name.
8.1.2 QC Query
In the data processing interface, click the “Data Management - Query” menu, click “QC
Query” menu, appear the following interface.

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Select the test item in the drop-down list, enter the From and To dates.
Data and QC Lot and Value within a period of time are displayed in the QC value
column. If several quality controls are made in the same day, we need to choose an
appropriate data as a quality control chart parameters (the default value is the first data),
the statistics column automatically calculates their average value, SD, CV. Quality
control chart shows quality control graphics, click “Print” to print.
8.2 Reaction Curve Monitoring
During test, each test item, the instrument read a set of data on eight wavelengths every
circle for each test item. There is a total of 40 point value for each tested item; we can
observe the reaction of the whole process to understand the correctness of the results.

Click the “Data Management- Reaction Curve” to enter the following interface:

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In Date column, listed all stored dates data. Click the "Delete” button to delete all the
data of selected date

!! ! Note: Be careful to use the “Delete” button. After delete, data can not be
recovered.

Click “Date” button, select the date.

Select the types of specimens that you want to query in Sample, Calibration and QC.

If you choose Sample, sample number displayed in the Sample No. column within that
day, select the correct number of samples, the samples tested in the project displays on
the Item list;

If you want to observe the test data, click the "Data" button; the interface displays all
the absorbance value of main wavelength auxiliary wavelength and the difference
between the two, click the "Data" button again to exit,. Repeat the above process, you
can query, calibration and quality control; click upper right corner "x" to exit the
response curve monitoring interface.

8.3 Data Maintenance


Data maintenance is a module to effectively maintain the printing report and its dates.

Click "Data Management-Data Maintenance” menu to enter the following interface:

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In the Report Format column, you can enter the name of the hospital which produced
the report, place print order. In the Data column, you can input Units, Departments,
Diagnose, Doctor and Sample Type.

!! ! Note:
1. When edit the Item Order, it should be arranged all the items (contain
computational item and manual item); otherwise the item data will not be printed.

2. the item has been deleted in” Parameter- Item parameters”, it should be also
deleted here, otherwise it will go wrong!

9. Maintenance

9.1 Instrument Initialization


Click “Service And Adjust-Initialization", the instrument reset can be reset.
9.2 Instrument Test
If instrument failure appears, you can use the instrument software to test the various
components in order to find the cause of the malfunction; click “Service And
Adjust-Parts Testing” menu, the software interface is as follows:

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9.2.1 Syringe Test


There are Reagent syringe and Sample syringe. There is a text box after each syringe,
enter the Volume and click the execute button, syringe will move to the shape of
desired volume. Click the "Original” button syringe moves upward to the original
location; if syringe does not move or not move to the desired shape, there is a fault of
the syringe.
9.2.2 Sample Arm Test
Mechanical movement test of sample arm is done by “Original” button. It can move to
the level zero, reagent place, sample place, the reaction cup place. We can detect the
vertical position of the sample arm. (The test of cleaning arm and mixing arm is the
same of that of sample arm).
9.2.3 Tray Test
The instrument panel has three trays: Sample Tray, Reagent Tray and Reaction Tray,
there is a text box in the back of each tray, if input the number, click the execute button,
the corresponding tray will move to the desired location, click the zero button, tray
reset.
9.2.4 A\D Reading
Click the “A / D reading”, each wavelength signal readings will be displayed in their
respective text box, if the signal value is not normal, indicating that the data channel
has fault.

9.3 Adjustment
!! ! Note: The instrument adjustment procedures must be carried out by
professionals. To avoid damage is done to the machine non-professionals, we set
the password: 666666.

It’s mainly to adjust the position of the “Sample Arm” needle, “Reagents Arm” needle,

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Sample Mix Arm, and Wash Arm.
Click “Service And Adjust-Adjustment” menu, enter the password “666666” to enter
the interface as follows.

9.3.1 Horizontal Adjustment of Sample Arm


This adjustment corresponds to “Sample Arm >> Horizontal”. Place1=washing position,
Place2=No.1 sample position, Place3=No.16 reaction position, Place4= No.31 sample
position. We can adjust the horizontal position of the sample arm through “+1 Step”
and “-1 Step” button, save the changes through "Ok" button, "Cancel" button to
abandon changes.
9.3.2 Vertical Adjustment of Sample Arm
This adjustment corresponds to “Sample Arm >> Vertical”.Place1=washing depth,
Place2=No.1 sample depth, Place3=No.16 reaction depth, Place 4=No.31 sample depth.
Adjusting with the help of “+1 Step” and “-1 Step” button to make pipetting needle
reach the maximum depth. If the pipetting needle can not touch reagents or samples in
this depth, the instrument can not test the specimen. "Ok" button to save the adjustment,
and “Cancel “button to abandon the adjustment.

Pipetting needle is better to be adjusted to the bottom position of the sample cup.

!!! Note: Sample cup and test tube could select one only during adjustment.
9.3.3 Horizontal Adjustment of Reagent Arm
This adjustment corresponds to “Reagent Arm >> Horizontal”. Place1=washing
position, Place2=No.1 reagent position, Place3=No.1 reaction position. We can adjust
the horizontal position of the reagent arm through “+1 Step” and “-1 Step” button, save
the changes through "Ok" button, "Cancel" button to abandon changes.
9.3.4 Vertical Adjustment of Reagent Arm

Address: No.51 South Gongye Road, Jinan, Shandong, China 250101 44


Biobase Biodustry (Shandong) Co., Ltd
This adjustment corresponds to “Reagent Arm >> Vertical”.Place1=washing depth,
Place2=No.1 reagent depth, Place3=No.1reaction depth. Adjusting with the help of “+1
Step” and “-1 Step” button to make pipetting needle reach the right depth.
9.3.5 Adjustment of Wash Arm
This adjustment corresponds to “Wash Arm”
Place1=wash arm up and down
9.3.6 Adjustment of Sample Tray and Reagent Tray
Horizontal position of sample tray, reagent tray should be in the middle position of the
pipetting needle, if there is any variant, just modify the data then could adjust the
position, until adjust to the middle position.
“R1 Tray 1” for reagent tray, “Sample Tray 1” for sample tray.

9.4 Instrument Maintenance


9.4.1 Daily Maintenance
1. Clean bucket, empty waste water bucket everyday;
2.Check the position of pipetting needle and its position. Check whether there is
blockage in the head of reagent needle and samples needle;
3.Check whether there is blockage in cleaning.
9.4.2 Weekly Maintenance
1. Use cleaning fluid to clean the pipetting needle, reagent needle and mixing needle;
2. Clean the surface of the instrument;
3. Clean reagent tray.
9.4.3 Half Year Maintenance
1. Check whether the light source lamp is normal; replace it if necessary;
2. Check whether the injection pump is working properly;
3. Check whether the syringe leaks. If necessary replace it with a new syringe.
9.4.4 Annual Maintenance
1. Check whether the power supply voltage and the ground wire is in good contact.
2. Maintenance robotics arm.
3. Water pipe replacement.
4. Adjustment of the instrument arm position.

9.5 Spare Parts Replacement


9.5.1 Light Source Lamp Replacement
It is generally required to replace the light source lamp within six months or after 1500
hours working.
1. Open the rear cover.
2. Remove the light cover.
3. Remove the old light source lamp and replace it with a new one (12V 20W) .Note
that the connector must be firm.
4. Assemble the light cover.
5. Assemble the rear cover.

! ! ! Note: When replace lamp, power must be cut off to avoid electrical shock; and

Address: No.51 South Gongye Road, Jinan, Shandong, China 250101 45


Biobase Biodustry (Shandong) Co., Ltd
you have to wait until the old light source lamp cools completely before replacing
new one so as to avoid burns.

9.5.2 Syringe Replacement


Syringe may be leaking after working for a period of time (six months or so), and then
it must be replaced.
1. Remove the rear cover.
2. Replace a new one, and note that screws should be set firmly.
3. Assemble the rear cover.
9.5.3 Reagent/Sample Needle Replacement
If damaging a needle accidentally, you must replace it with a new one (need
professionals do the replacement and adjustment work).

1. Carefully remove the top cover of the needle.


2. Remove the screws.
3. Change a new needle.
4. Fix the needle.
5. Adjust the position of the needle by using the procedures software of needle
adjustment.
6. Cover the top cover.
!! ! Note: The position of the needle must be aligned (adjust rightly); otherwise it
will damage the new needle.

10. Malfunction Analysis

10.1 No respond after startup.


Check the power plug and the instrument fuse.

!! ! Note: Please use the fuse with a specification of φ5 × 20. Please replace the fuse
according to the specification marked on the instrument.

10.2 Light source lamp not work


Check whether the light source lamp is burned-out. The light source lamp is of 12V/
20W.Replace it if it is broken.
10.3 Reagent/sample needle not be washed
Check whether the water pump is working. If the pump is normal, please check the
waterway connecting pipe. If it comes off, please connect the pipeline. If the pipe gets
clogged, replace the pipe. If the water pump can not work correctly, replace it.
10.4 The volume of sample/reagent is not added accurately
Check whether the syringes and the pipes is leaking, and whether the head of pipetting
needle be clogged, and then replace them with new pipe or syringe.
10.5 Position of sample/reagent needle is offset

Address: No.51 South Gongye Road, Jinan, Shandong, China 250101 46


Biobase Biodustry (Shandong) Co., Ltd
Adjust the position of sample/reagent needle through the instrument adjustment
software.

10.6 Result of one item is not accurate


Check if the reagent and adding volume works well. And observe whether other items
are normal under the same wavelength. If not normal, replace the light filter.

!! ! Note: If the fault can not be ruled out, please contact maintenance engineers of
the OEM Company.
Remarks:
The accuracy of test results of automatic biochemistry analyzer is mainly decided by
two factors:

First, the reliable analytical instruments. Second, the reagents of stable performance.
Both are indispensable. In the basis of ensuring high quality instrument performance, we
suggest users buy trustworthy quality product for the accuracy of your test results.
Firstly, the reagent is approved by the related institutions. Secondly, the products are
verified by the majority of users.

Address: No.51 South Gongye Road, Jinan, Shandong, China 250101 47


Biobase Biodustry (Shandong) Co., Ltd
11. Warranty Commitment
1. Warranty period lasts twelve months from the date of purchase.
2. During the warranty period, if the instrument is damaged due to improper use
or any unexpected accident, the company will not assume any responsibility or
obligations.
3. After the warranty period, the company is also responsible for maintenance, but
it will charge maintenance fee.
Please provide maintenance organizations or maintenance personnel trained and
approved by the company with drawings of the instrument and part of the
necessary technical data.
4. Please contact the service department of the company to purchase the spare
parts. Not OEM spare parts are likely damage to the instrument and affect the
accuracy of the instrument.
Note: Cuvettes, sample cup, reagent bottle, halogen lamp, syringe, sample/reagent
needle and fuse are all consumables and not included in the warranty.

Manufacturer: Biobase Biodustry(Shandong) Co., Ltd.

Jinan Biobase Biotech Co.,Ltd

After-sale Service: Jinan Biobase Biotech Co., Ltd

Address: No. 51 South Gongye Road, Jinan, Shandong, China

Web: www.biobase.cc

Address: No.51 South Gongye Road, Jinan, Shandong, China 250101 48

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