DR-200Bc User Manual

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Version:6.

Microplate Reader

Instruction Manual

English
Table of Contents

Section 1 Important Safety Instruction ......................................................................... 1


Section 2 Introduction of instrument ............................................................................ 2
2.1 Application Scope....................................................................................................... 2
2.2 Main Performance ...................................................................................................... 3
2.3 Main Function............................................................................................................. 3
2.4 Main Structure and Components ................................................................................ 3
2.5 Specification and Technical Parameter ...................................................................... 4
Section 3 Instrument Installation .................................................................................. 5
Section 4 Input Tool and Operation.............................................................................. 7
4.1 Touch Screen&pen ..................................................................................................... 7
4.2 Digital soft keyboard .................................................................................................. 8
4.3 Character soft keyboard ................................................................................................. 8
4.4 Date、time soft keyboard ........................................................................................... 8
4.5 Formula soft keyboard ................................................................................................ 9
Section 5 Start-up ......................................................................................................... 9
5.1 Procedure of start-up................................................................................................... 9
5.2 Main Menu ................................................................................................................. 9
Section 6 System ........................................................................................................ 10
6.1 Main Menu ............................................................................................................... 10
6.2 Data Delete ............................................................................................................... 11
6.3 Dictionary ................................................................................................................. 11
Section 7 Item Setup ................................................................................................. 12
7.1 Measure method........................................................................................................ 12
7.2 Analysis method ....................................................................................................... 13
7.3 Add New Item .......................................................................................................... 14
7.4 Modify the item ........................................................................................................ 17
7.5 Delete the item .......................................................................................................... 18
Section 8 Test ........................................................................................................... 18
8.1 Test setting ................................................................................................................ 18
8.2 Plate Well ................................................................................................................. 18
8.3 Templet ..................................................................................................................... 18
8.4 Well Position ............................................................................................................ 19
8.5 Plate test .................................................................................................................... 20
8.6 Result view and print ................................................................................................ 21
Section 9 Sample Information ................................................................................ 21
9.1 Basic operation ......................................................................................................... 22
9.2 Sample(Patient) information..................................................................................... 22
Section 10 Search ................................................................................................... 23
10.1 Sample(Patient) data searching............................................................................... 23
10.2 Item Report ............................................................................................................. 24
10.3 Board Report........................................................................................................... 24
10.4 Standard Curve ....................................................................................................... 24
10.5 Quality Control Report ........................................................................................... 25
Section 11 Report ................................................................................................... 26
Section 12 PC Control ............................................................................................ 27
12.1 Software installation ............................................................................................... 27
12.2 Software running environment ............................................................................... 27
12.3 Software serial communication protocol and code ................................................. 27
Section 13 Shut down ............................................................................................. 29
Section 14 Instrument maintenance ........................................................................ 29
14.1 Summary ................................................................................................................. 29
14.2 Cleaning instrument ................................................................................................ 29
14.3 Instrument parts replacement.................................................................................. 30
14.4 Simple fault handling.............................................................................................. 30

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Section 1 Important Safety Instruction
Dangerous or wrong using method may cause electric injuries, burns, fire or other disaster.
Basic safety protection including all the followings should be always obeyed.
When the instruments are used near children, disabled people or samples, rigorous monitoring
should be performed.
1.1 Read the followings before using the instrument
1) Check correspondence of voltage equipment and supply voltage.
2) Connect with network source: Put the instrument plug in the socket which has a grounded power
cord.
3) Take the plug out after finishing operating the instrument.Do not place the instrument in a difficult
position to operate the disconnecting device.
4) You mustn’t put the instrument in or near liquid. If the instrument is wet, please take the plug out
before touch it.
5) Please do not leave the instrument alone when it is working.
6) The instrument can only be used for tests according to the manual.
7) Do not use spare parts which are not provided or suggested by the manufacturer.
8) If the instrument is in abnormal working position or damaged, do not operate it.
9) Do not make instrument and lines touch surfaces which are too hot.
10) Do not block vents. Make vents away from soft cloth, fur, lint etc.
11) Do not put anything on the instrument.
12) Unless special requirements of the manual, you can not put anything into opening, pipe or seam of
the instrument.
13) Do not use instrument in the place where exits aerosol, droplet or oxygen is controlled.
14) Do not use instrument outdoors.
15) When dealing with hazardous substances, it should be handled by professionally trained
personnel.
16) Keep far away from electromagnetic interference sources.
17) Avoid direct exposure of high light.
18) Manufacturers are responsible for providing electromagnetic compatibility information of
equipment to customers or users.
19) The user has the responsibility to ensure the electromagnetic compatibility of the equipment, so
that the equipment can work properly.
20) In dry environments, especially in the drying environment of artificial materials (artificial fabrics,
carpets, etc.), the use of this equipment may cause damage to electrostatic discharges, resulting in
erroneous conclusions.
21) Prohibit the use of this device near a strong radiation source (such as a non shielded radio
frequency source), or it may interfere with the normal operation of the equipment.
22) This equipment is designed and tested according to class a equipment in GB4824. In the home
environment, this device may cause radio interference and requires protective measures.
23) It is recommended that the electromagnetic environment be evaluated prior to the use of the
equipment.
24) This equipment complies with the emission and immunity requirements specified by
GB/T18268.26.

Note: The instrument used reagents and samples may be corrosive or infectious, please pay

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attention to the protection of instrument when do the operation, can use protective gloves, do not
come into contact with the skin, the waste must be in strict accordance with the management of
medical waste treatment system.

Note: The Microplate Reader is very professional precision instrument, the equipment
maintenance must be conducted by professional staff .When maintenance, repair, or movement
should do the cleaning and disinfection of instruments so as to minimize biological hazards, the
company promises to respond to user needs at any time, don't agree with non-professional
personnel engaged in the work related to the maintenance, repair, our company is not responsible
for the consequences.

1.2 Symbol
The following table lists the symbols used on the Microplate Reader and their significance.

Symbols Significance Explain

Identify the machine where you need to be careful and


Be careful,
make sure that you read the relevant contents of the
dangerous
operating manual before using the machine.
The symbol is marked on the machine to indicate that a
Biological hazards device is potentially contagious due to a sample or
reagent used.

The symbol is marked on the machine to indicate the


Serial number
serial number of the machine.

Vitro diagnostic The symbol is marked on the machine to indicate that


medical device the device is an in vitro diagnostic medical device.

Protective conductor
The symbol is marked to indicate ground protection.
terminal

The symbol is marked on the machine to indicate


Equipotential
ground.

Through (power) The symbol is marked on the machine power switch to


indicate instrument power on.
The symbol is marked on the machine power switch to
Break (power)
indicate instrument shutdown.

The symbol is marked on the machine nameplate to


Manufacture Date
indicate the date of manufacture .

The symbol is marked on the machine nameplate to


Service life
indicate the period of use of the machine.

Section 2 Introduction of instrument


2.1 Application Scope
The Microplate Reader is applied in clinical optical method for enzyme-linked immunosorbent
assay.

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2.2 Main Performance
Wavelength accuracy and transmission character of the filters should meet the following
requirements:
Item Indicator
Indication error of wavelength(nm) ±1.0
Half width(nm) ≤8
Peak transmittance(%) ≥35
-Measured value stability:±0.003A
-Absorbance indication error (Accuracy):±0.008A
-Absorbance repeatability: ≤0.2%
-Sensibility:≥0.01(L/mg)
-Channel error: ≤0.01A
2.3 Main Function
-Large screen interface, touch screen and touch pen input mode make it convenient for users to input
information.
-More than 500 programmable laboratory tests.
-Four measurement method: Single wavelength, Double wavelength, two point method, kinetic
-Several quantitative and qualitative methods: ABS, Cut-Off regression,Single-point calibration,
broken line regression, linear regression, exponential regression, logarithm regression, double
logarithm regression, log-logit, power regression.
-96-well visual plate. Blank hole, contrast hole, sample hole, standard hole and quality control hole
are adjustable.
-Conduct 12 different tests in one plate at the same time.
-Fast and accurate testing with 8 channels (≤10S/ Plate ) .
-Flexible synthesis report output, supporting internal thermal printer and printer with USB interface
2.4 Main Structure and Components
The instrument is made up of switch power supply, optical path system, inner computer system
and sample transmission system.

Front view: ③


① Power indicator light : After the instrument is power on, the indicator light is lit.
② Touch screen: Show software interface. Users can press the screen with fingers for variable
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operation
③ Internal thermal printer: Plastic cover plate. Paper delivery when using internal thermal printer.
You can open the cover plate to replace paper.
④ ELISA plate cover plate: Plastic cover plate. Prevent dust from polluting inner space of ELISA
plate and instrument.

Back view:

⑤ ⑥ ⑦ ⑧ ⑨

④ ④

① ② ③ ⑩

① Power disconnecting switch: Turn on or turn off the power supply.


② Power supply socket: Connect AC power line.
③ Fuses: If no power after turning on power supply switch, check the fuses.
④ Hinges: Connect bottom shell and top cover.
⑤ Parallel port : It is used for connecting parallel printer.
⑥ USB -B interface: It is used for connecting PC computer.
⑦ USB -A interface: It is used for connecting mouse & keyboard .
⑧ RS-232 Serial port :It is used for connecting PC computer.
⑨ USB -A interface: It is used for updating motherboard firmware.
⑩ Nameplate: Show instrument model, specification etc.

2.5 Specification and Technical Parameter


Net Weight: 8 kg
Dimension: 475mm(L)×340mm(W)×200mm(H)
Power supply: AC 100V~240V, 50/60 Hz
Fuses: 2-φ5×20 BGXP T 3.15 AL 250V
Environment temperature:+5℃~+40℃;Relative humidity: 15%~80%;Atmosphere
Working range:70kPa~106kPa;Power supply:AC 100V~240V, 50/60 Hz;Transient
environment: over-voltage is classified as device class (over-voltage) class-Ⅱ;Rating pollution
level is classified as class-Ⅱ.
Storage -10℃~+55℃
temperature:
Light source: Quartz halogen lamp OSRAM64607,8V/50W
Wavelength: 405nm,450nm,492nm,630nm,add at most 4 filters with wavelength between 400
nm and 850 nm.
Measuring range: 0.000~4.000A
Reading speed: Single Wavelength ≤ 3s,Double Wavelength ≤ 6s
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Warm-up time: 10 minutes
Computer ARM core series
system:
Programming More than 500
items:
Communication RS-232 serial、Parallel printer、USB、Mouse and keyboard interface
interface:
Display: LCD dispaly screen
Input mode: Touch Screen ,Touch pen
Memory 200,000 test data
Capability:

Section 3 Instrument Installation


3.1 Instrument Packaging and unpacking
Unpack the instrument package, and take out the instrument. Check items in the package
according to PACKING LIST: main instrument, power line, fuses, touch pen, instruction manual,
packing list, verify report ,dust guard ,PC software CD and so on .
3.2 Environmental Requirements
Choose flat worktable which is enough to place the instrument and without direct sunlight.
Instrument working environment:
1)Temperature: +5℃~+40℃
2)Relative humidity: 15%~80%
3)Atmosphere range: 70kPa~106kPa
4)Power supply: AC 100V~240V, 50/60 Hz
5)Transient over-voltage is classified as device class (over-voltage) class-Ⅱ, Rating pollution level is
classified as class-Ⅱ.
6)Good ventilation and no corrosive substances.
To insure normal operation of the instrument, you mustn’t put instrument in the following places:
temperature polarization, extremely hot or cold, with a lot of dust, near electromagnetic equipment.
3.3 Transportation and Storage Conditions
Transportation condition: Transportation should meet the requirements of the instrument and
package indication. Customers should check whether the package and instrument is OK when
receiving goods. If any problem, customers need turn on the instrument to see if it works.
Ship & storage condition: The instrument should be stored in a room with temperature -10℃~
+55℃, relative humidity less than 93%, atmosphere range is 70kPa~106kPa ,good ventilation and no
corrosive substances.
3.4 Service Life and guarantee
Service life: 8~10 years
Service guarantee: 1 year warranty and life-long maintenance.
3.5 Power Supply Requirements
Power supply voltage: AC 100V~240V, 50/60 Hz
Input power: 180VA.
—————————————————————————————————————————
Note: The AC power supply must be well grounded (protective grounding voltage<5V)Internal

protective grounding of the machine unified using with logo .The AC power supply must be
stable, don’t share power with high-power electrical appliances. When unplug the power line,, must
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grasp the plug itself, rather than the power line. If discover there is smoke, strange smell or strange
sound, immediately shut off the power and contact the seller.
3.6 Start installing
--Connect instrument to power source;
--Put one port of power line in power socket of the instrument ;
--Put the other port of power line in AC power socket.
3.7 Print paper installation
3.7.1 Press the printer cover plate, then remove the printer cover (figure 1).
3.7.2 Pull out of the printer roller and place the printer paper thermal surface down to the head
direction of printer . Press the printer roller (figure 2-3).
3.7.3 Put the printer paper out of printer cover plate,cover the plate (figure 4).

Figure 1 Figure 2

Figure 3 Figure 4

Note: 1. When pull the printer roller, pull in the middle.


2. When installing the printer roller, first install the gear side.

3.8 Notice and direction of sample collection and handling


The most common sample of inspection is blood, which includes serum, plasma and whole blood.
Sometimes saliva and urine are also tested as sample. Sample collection should obey clinical blooding
technology standard in principle, unless special requirements in the kit instruction.
Sample collection:

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- Serum sample collection: Draw a certain amount of venous blood with single-use syringe or
vacuum blood tube, and place it at room temperature for 1-2 hours. Centrifuge with speed after
3000r/minmore than 6 min after tarombokinesis and blood clot retraction, and suck serum in
reserve. You should take care when collecting samples. It is proposed to use evacuated blood
tubes or butterfly needles tocollect samples, avoiding direct contact with blood.
Sample storage:
- Serum or plasma sample which are used for antibody detection should be stored in temperature
below -20℃. Samples which will be tested during 1 week can be stored in temperature of 2~
8℃. Plasma and blood cell samples for antigen and nuclein detection should be cryopreserved in
temperature below -20℃.
Application of sample and incubation:
- Operators should use graduated transferpettors.
- When incubating, operators should check temperature and make accurate timing before put plate
in incubator or water-bath.
Washing plates:
- It is best to use microplate washer to wash elisa plates, also set soak time and washing times
according to reagent instruction.
- When hand washing, try to avoid cross contamination.
Color development:
- Color developing reagent should be taken out from refrigerator 10 minutes before using. When
adding color developing reagent, keep dropping bottle straight down and holding pressure
uniform, besides dripping speed not too fast. Do not mix reagent A and B before adding, you
should add A and B in turn.
Reading plates:
- After color development, operators should use microplate reader to read the elisa plates during
required time of the instructions’.
- After reading plates, operators should process sample plates as pollutant.
Waste processing
- Regard kit as infectious substance and process it according to laboratory regulation about
infectious disease. ( Refer to reagent instruction’s requirements).

Section 4 Input Tool and Operation


4.1 Touch Screen&pen
The Microplate Reader uses touch screen & touch pen as basic input device. The user operates
within the scope of the screen. Basic operations only have 1 kinds:
(1) Click: Touch the screen with a finger or pen then leave;

Warning:
The Microplate Reader use touch screen: do not use sharp or hardness of objects (such as
metal, glass, nails, etc.) touch screen surface; Part of touch screen is glass, do not exert great
impact on touch screen, so as to avoid damage.

The grounding of AC power supply must be good, otherwise it may affect the sensitivity of touch
screen.

Note: The Microplate Reader can be equipped with an external mouse, keyboard.

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4.2 Digital soft keyboard
The enter window can be used to input integers (such as sample numbers, etc.), decimals (such
as concentration values etc.). The enter content consists of 0~9 and decimal points. After completing
enter, press the “ OK ” button to confirm ,or press “ Cancel ” button to abandon content.
Change the content: Press the "Back" button to delete the first character of entered ; Press the
"Clear" button to clear all the content you've entered.
The window title bar is prompted with enter content and its limits. If user enter exceeds the limit,
the system will be discarded automatically. The system has the following restrictions on user enter
content:
1) The value entered shall not exceed the max or min; If the min is non-negative, press the "-"
button is invalid.
2)When enter an integer, press "." button is invalid.

4.3 Character soft keyboard

The enter window is used to input characters and alphabetic strings.


The "English" button means that the current enter state is English, and the "Chinese" button means
that the current enter state is Chinese, and this button can be changed with English & Chinese system.
All buttons on the soft keyboard are similar to the ordinary PC keyboard, and the "Back" button is
used to delete characters, and the "Cap" button is used to switch the case of the entered letters. To cancel
this entry, click the “X” button at the upper right corner.

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4.4 Date、time soft keyboard
For entering date and time, sliding the number up or down can change the current selection state.

4.5 Formula soft keyboard


Used to enter a qualitative formula.

Section 5 Start-up
5.1 Procedure of start-up
Turn on the power switch at the rear panel. Wait about 6 seconds, the instrument will perform an
initialization process.
The procedure of start-up includes:
1)Load the program;
2)Access the user data;
3)light road and mechanical self-examination: during the period, the filter wheel will rotate, and the
enzyme plate will approach a round trip.
If an error occurs during initialization, the system pops up a window to report an error message. Users can
refer to the "Simple fault handling" section of this manual “Instrument maintenance”. If can’t solve it,
please contact the seller.

5.2 Main Menu


The screen displays the main menu after the procedure of start-up. The main menu has 8 different
modes: Test,Item Setup, Report, Sample ,Search,Dictionary,System and Data Delete.

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Section 6 System
Click “System” button in the main menu and go into the system setting menu.
6.1 Main Menu
Select the “System” button and go into the system setting menu:
1)Serial No.(ID): This number is read-only and cannot be modified;
2)Company Name: No more than 20 characters (including Chinese and English characters);
3)Report Title: No more than 20 characters (including Chinese and English characters;
4) LCD& Sound: Click "<<" or ">>" to adjust the contrast of the LCD screen;
5) Sound : Click to activate or close the beep sound;
6) Regional: Modify the time display format and system language;
7) Date&Time :The current date and time can be entered;
8) Print:Select the printer model, which supports KX-P1121 needle printer/EPSON-LQ300K+ needle
printer/ Built-in thermal printer;
9)Work Mode : Select Stand-Along or PC mode work;
10) Input Device : Select the current mode of operation as the Key & Mouse or Touch input;
11) Maintenance: Provides a range of system detection functions, including Add Filters, Lamp Test, Repeat
Test and so on;After you modify the parameter, click “OK “ button to save the settings, and then click
“Back” button to quit.

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Click the ‘Maintenance’ button to go into the system maintenance menu.
 Add Filters: First select the number of filters, then fill each filter wavelength corresponding each
well, click "OK" button.
 Lamp Test: The function is mainly used to replace the lamp. After selected the filter, click the
"Start" button, and then manually adjust the position of the lamp, while observing the test value;
adjust to the maximum value, fixed the lamp.
 Repeat Test: This function is mainly used for detecting instrument performance. Select filter, test
times and row to test, the system will calculate the average value, CV value, and repeatability
value automatically.
 Self Test:This function mainly test if the mechanical parts of the instrument can be used
normally.
 Background Color Set:This function sets the background color.
 Advanced: This module is only used by the serviceman/manufacture.

6.2 Data Delete


 In the main menu , click the ‘Data Delete’ button to go into the menu of data deleting. This
window makes it easy for users to delete data in bulk. Select the option to delete, click “Delete”.

6.3 Dictionary
In the main menu, click the ‘Dictionary’ to go into the editing interface of dictionary.
This window provides addition, modification and deletion for seven dictionary information.Including
Clinical Lab, Submit Dep., Lab Doc.,Submit Doc. ,Sample,Diagnosis,Unit.

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Add: Click the “Add ” button and then enter the relevant information in the soft keyboard.
Modify: First select a dictionary item then click the “Modify ” and enter the relevant information in
the soft keyboard.
Delete: First select a dictionary item then click the “Delete”,delete the selected dictionary item.

Section 7 Item Setup


In the main menu, press the “Item Setup” button to enter the item list window:

The Microplate Reader all items are defined by the user. Items that have been set by the user are
displayed in the window list.
7.1 Measure method
The reader has four measure methods.
7.1.1 Single wavelength
The method uses one wavelength to measure the OD.
7.1.2 Dual wavelength
The method uses two wavelengths to measure the OD. The result of OD is the difference of the main
wavelength and the second wavelength.
7.1.3 Fixed time
Absorbance values were measured at two different time points. The absorbance value is the difference
between the second detection value and the first detection value.
7.1.4 Kinetics
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The absorbance was measured several times according to the interval between the intermittent time
and the delay time. According to the slope of the absorbance curve obtained by the regression, the
absorbance value of 1 minutes was used as the absorbance value, and the concentration value was
calculated.
Note: the kinetic method uses only one wavelength.
7.2 Analysis method
There are 9 analysis methods, divided into the following 3 categories:
7.2.1 O.D. mode
The absorbance of the sample is measured and output directly.
7.2.2 Qualitative(Cut-Off) mode
Cut-Off limit formula: Cov  X  NC  Y  PC  Fac
NC is the O.D. of the negative reference material,PC is the O.D. of the positive reference material,
X,Y,Fac is the coefficient,which is set in the reagent instruction.All the other kind of qualitative formula
can convert into this formula format.For example:if Sample OD/Negative Ref.OD≥2.1 is the Positive,then
X=2.1,Y=0, Fac=0。
The result of qualitative calculation is expressed by the ratio of sample absorbance to cut-off
threshold, the unit is s/co. Generally, the value of negative and positive is determined with 1 as the critical
value.
7.2.3 Quantitative mode
1) Single regress:need to set 1 standard, take the line of origin and standard point as the calibration
curve. Single regress must set blank to calibrate 0.(X:concentrate,Y:O.D.):
O.D.

C
2) Multi regress(point - point) :allow set 2-8 standard samples ,take each standard point as the
calibration curve (should be a monotonically ascending or downward fold) :
O.D. O.D.

C C
If the absorbance of the standard sample does not increase monotonically or decrease monotonically,
the calibration result is error:
O.D.

C
3) Linear regress:allow set 2-8 standard samples,a straight line Y  kX  b is regressed by these
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standard points as a calibration curve:

O.D.

Exp. Regress:allow set 2-8 standard samples,an exponential curve Y  ke


bX
4) is regressed by these

standard points as a calibration curve,all the standard sample O.D. values must be >0 .
If the absorbance value is logarithmic ( Y   LnY ), the exponential regression can be transformed
into linear regression: Y   k X  b  .
5) Log Regress:allow set 2-8 standard samples,a logarithmic curve Y  kLnX  b is regressed by
these standard points as a calibration curve,all the standard sample concentration values must be >0 .
If the concentration is logarithmic ( X   LnX ), the logarithmic regression can also be transformed
into linear regression: Y  kX   b .
( kLnX  b )
6) Dual Log:allow set 2-8 standard samples,a double logarithmic curve Y  10 is regressed

by these standard points as a calibration curve,all the standard sample concentration values must be >0 .
If the concentration is logarithmic ( X   LnX , Y   LnY ), the logarithmic regression can also be
transformed into linear regression: Y   k X   b 

Power Regress:allow set 2-8 standard samples,a power curve Y  kX is regressed by these
b
7)

standard points as a calibration curve,all the standard sample O.D. values and concentration values must
be >0 .

7.3 Add New Item


Click the “Item setup” icon in the main menu and go into the item list window.
Select“New” to add new item。
The parameter of the item setup:
● Item Name : Item name, string including 20 characters at most,blank unallowed;
● Full name: Item full name, string including 20 characters at most, blank allowed.
● Reagent: Reagent name, blank allowed.
● Method: Select the test method from four methods.
● Main/Second Wavelength: Select from the wavelength list,and the second wavelength should be
different with the main wavelength;
● Wait Time:Fixed time method and kinetic method need to fill the wait time, ranging from 10 to 120
seconds.
● Test Times: Kinetic method need to fill the test times, ranging from 2 to 10 times.
● Analysis: Different type analysis methods, selected from the list of methods.
● Sample type: Can select one from Single Sam/Double Sam/Column minus. Double Sam is the
average value of two samples , Column minus is the difference between two samples .
● Blank Max.:Define the max. value according to the the reagent blank.For example,the reagent needs
the blank less than 0.05,then the blank must be ≤0.05. If the blank O.D. is larger than the max blank, “The
blank value is too high”will appear and the maximum blank is used as the blank automaticly.

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Blank : The blank contrast absorbance value of the actual test.
● Ref. Area: The scope of the calculation results of the item.Some items can be entered 0.000 ~ 0.000 if
the user does not need to print the reference range.
● Sort No.: Define the sort of the item in the patient report. The small No. is in the front of the list. The
default value is 100.
● ABS analysis methods:Press the “OK ”to save the item information and press the “Cancel” to exit the
settings for the current items;
In addition to ABS, other calculations can be found on “Standard/ Conrtol Settings”, “Qualitative
Setting” and “Quality Control Setting".

If the analysis method is Cut-Off, click “Standard/ Conrtol Settings” to view the menu:
● Negative/Positive Ref Area:The valid reference area of the Negative and Positive,the default value is
0.000~4.000;
● Negative/Positive 1~4:User can see the OD of the Negative/Positive after test, or set the OD directly
without test.Then click “Qualitative Setting” .
● Qualitative Group Name:User can define the name or signal of every group;
Click the label “Group 1”~“Group 5” to set the predefined name,which will shift between the
“Negative,Weak negative,Grey Area,Weak positive,Positive”;
● Formula(Cut-Off value):User can define the C.O. formula or value of every group, four formulas at
most;
The relation of the Cut-Off value、OD value and qualitative is:
- +
Cut-Off value OD
From the manual of the ELISA kit, the formula of the Cut Off is “Cut Off value=Negative × 2.1”, so
the formula should be 2.1*NC1;If there are comments like“Minimum Negative OD = 0.05 ”,the meaning
of the comments is to get the large value of the NC1 and 0.05,so the final C.O. formula is:
2.1*MAX(NC1,0.05)
This is the formula of the Group 1. There are four formulas at all. And the value of the formula must
be “Formula 4 >Formula 3> Formula 2> Formula 1”. The five groups have four formulas.
If the item has more formulas, the CO value in S/CO could be selected from the four formulas. The
default value is 1.
If the formula is longer than the viewing area, just click the formula before the group label to show
the full formula in the last line.

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In addition to the formulas Cut-Off and ABS, click the “Standard/ Conrtol Settings” to display the
quantitative settings interface, and you can modify the following parameters:
● STD numbers: In addition to Single regress only can set 1 standard samples ,others can set 2~8
standard samples.
● Dilute Multiple:Define the dilute multiple of the sample, and the calculated value should multiply the
dilute multiple.
● Unit: Choose unit from the 24 common units in the list.
● Dual STD: If check the dual STD,all the standards in the plate will be positioned double times.

Di
● ABS percent: Check the box to use  100% as the ordinate of the standard graph,the D0 is the
D0
reference standard of 100% O.D., and the D0 needs no concentrate. If the item selects the ABS percent, the
first standard is D0 when position the plate. The dual logarithm regression cannot use the ABS percent
because of the ordinate is in logarithm.
● STD concentrate table: Display and select the STD concentrate. Attention: All the STD concentrate
should increase.
● Modify concentration: Modify the selected concentration.
Then click “ Qualitative Setting” .
● Qualitative Group Name:User can define the name or signal of every group;
Click the label “Group 1”~“Group 5” to set the predefined name,which will shift between the
“Negative,Weak negative,Grey Area,Weak positive,Positive”;
● Formula(Cut-Off value):Users can define values or formulas for each grouping, while supporting
multiple formulas.

16
If the item needs to set quality control, you can click “Quality Control Setting”. This instrument
supports the known X, SD method, L-J method and instant quality control method.

● Batch number: The currently set quality control lot number.


● Multi-rule method: If the multi-rule method is not checked, the conventional judgment method is used.
When adding a new item, the new item will not be created if the items number has exceeded 500, the
system prompts that “The number of items is full”. The operation of adding a new item is the same as the
procedure for changing an old project. Note that the name of the new item entered cannot be repeated with
the existing item, otherwise the system will warn that “The item already exists".
7.4 Modify the item
Select an item from the list and click the “Modify” key to modify the item setting.
After the Cut-Off items is modified, the values of each contrast are retained and the CO values are
recalculated. (this product supports multiple formulas).
After the quantitative items are modified, the absorbance values of each standard are retained and the
17
curves are re plotted.
Note: When the number of standard samples or contrast negative /positive changes, the standard
samples absorbance and the curve , all CO values will be removed.

7.5 Delete the item


Select an item from the list and click the “Delete” key to delete the item.
Note: Do not delete items that have been built and tested at will, otherwise it will cause errors in
saved data! To delete certain items, make sure that no data is saved in the system. (You can delete data in
the data deletion module first)

Section 8 Test
8.1 Test setting
Click the test button on the main screen and enter the test parameter settings window.

● Plate Direction:select Horizontal or Vertical position;


● Moving Mode:select the plate continuous moving or stepping moving;
● Shaking speed:select the slow、medium or fast shaking speed;
● Shaking time:select the time of shaking plate, user-defined area is from 10 to 180 second.
● Import Templet:You can import the default layout template.
● Shake:Separate shake plate and mix the sample to be tested.

8.2 Plate Well


* 1 2 3 4 5 6 7 8 9 10 11 12
A A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12
B B1 B2 B3 B4 B5 B6 B7 B8 B9 B10 B11 B12
C C1 C2 C3 C4 C5 C6 C7 C8 C9 C10 C11 C12
D D1 D2 D3 D4 D5 D6 D7 D8 D9 D10 D11 D12
E E1 E2 E3 E4 E5 E6 E7 E8 E9 E10 E11 E12
F F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12
G G1 G2 G3 G4 G5 G6 G7 G8 G9 G10 G11 G12
H H1 H2 H3 H4 H5 H6 H7 H8 H9 H10 H11 H12
The direction of the plate’s moving is ←——。

8.3 Templet
Click the “Import Template” button to display the template selection window.

18
Select an existing template and click “OK “to import the template.
Contains all of the information in the template layout: layout direction, moving mode, item no ,type.

8.4 Well Position


Click "OK" button, enter the test setup layout window .

The The Microplate Reader allows users to set wells at any position within the 96 orifice plate.
-The procedure of the position:
a) Click “Set” to select the item;
b) Click “S,B,N,P,D,Q,C” to select the type of the sample;
If you need multi item board layout., click on the "2nd" or ">>" button, select the item and layout
again. Repeat the steps until the completion of the board layout.
Well mark symbol:
● Sample:S
● Blank:B
● Negative contrast:N
● Positive contrast:P
● Standard:D
● Quality Control :Q
● Clear:C
-Sample
User could click any hole to set the Sample.Click the hole again to modify the Sample No.The area of
the Sample No. is from 1 to 999.
-Blank

19
The blank is used to do zero adjustment.It means that all the other hole’s OD should minus the Blank
OD.If the Blank is not positioned, the default blank is zero.
Every item can position more than one blank wells.If there are several blank holes in the item, the
result only displays one mean blank value(average value).
-Negative contrast
The negative contrast is valid only in the Cut-Off items.User must position the negative contrast
according to the Cut-Off formula.Every item can position one or more negative contrast. If there are
multiple contrast values in one item, the result displays each contrast value.
The absorbance value of the contrast well in the test of the item will be automatically saved. In the
follow-up test of the same item, if the contrast is not reset, the system will use the old contrast value for
calibration.
-Positive contrast
Positive contrast is set as same as Negative contrast.
-Standard
Valid when standard calibration is required in item setting. If the item already has old standards, users
can choose not to set standards (use the old standard calibration) or reset all the standard samples, not
allow only set part of standard samples. Users click on the standard well, and the system also marks it D1,
D2.. If the standard has not been set, the user begin doing the test, the system will prompt "Standard layout
error".

Note: If a standard is set up in a item test and the calibration result is correct, the new standard will
cover the old standard of the item .

-Clear
User can click the hole to clear after select the “Clear” button. And only the hole of the current item
can be cleared.
-Batch
Press "Set" , then press “Batch ”, only the sample can be batch positioned. In the batch sheet window,
set the starting position, the end position and the initial sample number, and press "OK".
-Templet
Press "Set" ,then press “Board Templet ” to enter the template setting window. The template is a
specific type of cloth board, which can be set according to the usage habit, simplifying the daily fabric
operation. In the template window, you can add, delete, and cover templates.
-Choose way
There are four ways of orifice plate, after selected well position type:
● Click the well to set a well;
● Click the number(1—12)to set a column of wells;
● Click the alphabet(A—H)to set a line of wells;
● Click the “*” to set all the wells.
All the ways is valid to “Clear ”operation.With the function of "*", the cloth board of large quantity
samples can be carried out quickly.

8.5 Plate test


After all the settings, click “Ok” to move the plate and read the absorbance automaticly. The first time
of the test needs some minutes to stablizate the light source.

20
8.6 Result view and print
After the plate reading, automatically enter the test result window.

.
If the layout for the multi item layout, convenient for users to view data from the display, you can
select the item to display from the display item drop-down list, unrelated items will be shielding.
Click "Layout" to check the condition of layout board.
Click "ABS" to view the absorbance value and click the single sample well position to modify the
sample absorbance value.
Note: If the measured absorbance is > 4.000 A, it is shown as 4.00 *; < 0.000A will show as 0.00 *.
Click “Qualitative” to view the qualitative of the result according to the setting of the item.
Click “Quantify” to view the calculated value. In the Cut-Off item, the quantitative value is the value
of S/CO. But in the quantitative item, the value is the calculated concentration.
Click “Save” to save all the values of the plate. The memory of the instrument can save more than two
thousand plates.Save success will prompt "Save success!"
Click “Print” to print all the values by the position. The holes that not positioned will be neglected
automaticly.
Click “ Back ” to layout interface.

Section 9 Sample Information


Click the “Sample Info” icon in the main menu to enter the setting of the sample information.

21
9.1 Basic operation
Includes adding, modifying, and deleting patient information.
Operation procedure:
First of all, enter the test date, the form will list the sample no. and patient name for the specified date
be based on patient information and samples of the test.
Click the “Add” button to add a new patient message;
Select a patient item and click the “Modify” button to modify a new patient message;
Select a patient item and click the “Delete” button to delete patient information from the selected
patient.
Click the “ Last Page” & “ Next Page ” to display the patient information on the last page or next
page.
Note: If you add patient information, be sure to check the date of submit date and test date, otherwise there
may be errors.

9.2 Sample(Patient) information


Click the “Add” , the patient information edit control, which allows the user to edit.
Sample No. : When modifying patient information, you can modify the sample number, but need be
careful this operation, so as not to cause errors;
Name: 6 bytes in length;
Sex: Male and female, default is blank;
Age: 0 - 150 years old, default 0 years old;
Bed No.: 9 bytes in length;
Medical record No: 9 bytes in length;
Sample type: Set in the dictionary function module, here only needs to select one item;
Submit department: Set in the dictionary function module, here only needs to select one item;
Submit doctor:Set in the dictionary function module, here only needs to select one item;
Inspection clinial lab: Set in the dictionary function module, here only needs to select one item;
Inspection lab doctor: Set in the dictionary function module, here only needs to select one item;
Submit date : Defaults to the same day, but the user can also modify;
Test date : When the patient's information is modified, the date of test may be modified, but the
operation shall be carefully taken so as not to cause any error;
Which department type and inspection doctor is selected in the drop-down list, the list comes from the
management information database, which operates in the dictionary function module.
After the patient information input is completed, press click “Save” to save the changes. Otherwise, it
22
is considered to abandon modification.

Section 10 Search
Click the ‘Search’ icon in the main menu to go into the menu of data searching.

10.1 Sample(Patient) data searching


Press the “Sample Data” button, and then click “OK “ to enter the patient window. The patient form
shows the test date, sample number, name, sex, and total number of all patients(count) eligible for the
inquiry.

You can enter the send date , test date , name, sample number to search,search conditions is one of
them.
For example: the send date is "2017-04-01", and all patients on 2017-04-01 can be searched.
For example, the sample number is 12, and all patients with a sample number of 12 can be searched.
● Select a patient item and click the “Sample report” button to enter the sample report window. View
patient details at this window. Such as item name, result, unit / figurate and normal range of the item. Can
also print, delete the sample report.
● Select a patient item and click “Patient information” button to enter the patient information window
to view the patient's information.
● After select a patient item,the first column of the table will appear the words "P", click again can
cancel it .Can click “ Select all ” , add "P" to multiple patient items, click “Print” can continuously print
multiple patient report.
Click “Last page ” & “ Next page ” to view other patient information.

23
10.2 Item Report
Press the "Item report" button and click "ok" to enter the itemst test result search. Search according to
Item name and Test date .

The item report window displays the patient's name, sample number, result, and figurate of all test
results which is specified item and date. You can also click "Print" to print the item.

10.3 Board Report


Press the "Board report" button and click "ok" to enter the whole board test result search. Search
according to Plate No. and Test date .

The contents of the board report are in accordance with the test results.

10.4 Standard Curve


Press the “Standard curve” button and then click the “OK ”button to enter the standard curve search.
Search according to Item name .

24
The Cut-Off item shows absorbance and formula values for each contrast sample.

The quantitative items show the concentration and absorbance of each standard sample and show
curves simultaneously.

10.5 Quality Control Report


Click the QC report search method, and select the item, month and quantity to be queried in the search
options. After clicking OK, the data found will be displayed.

25
● Quality control data: Quality control data found.
● Quality control picture: A quality control chart drawn from quality control data.

Section 11 Report
In the main interface, press the "Report" button to enter the comprehensive report window. This
button is ashortcut to check patient reports for the day.

26
Section 12 PC Control
12.1 Software installation
The instrument can be controlled by the PC machine through the serial port, using PC interface
software, more powerful, more convenient to connect to hospital management system, if using this method,
the instrument must be set as follows: (the software instructions, please refer to the online help software)
● Click on "System "
● According to the connection mode with PC, in the working mode select "PC mode RS 232" or
"PC mode USB""
● Click "Save"
Note:If you need to install the software, please contact the agent or manufacturer. After setting to PC
mode, the “Test” button on the main interface will be clicked invalid.

12.2 Software running environment


Operating system: Windows XP,7,8,10
Hardware environment: Pentium III350 above, memory 128M, hard disk excess capacity of 500M or
more, resolution 800*600 and above
Mode of communication: Serial communication,USB
Communication interface: RS232 serial port,USB
Baud rate: 19200

12.3 Software serial communication protocol and code


1)Frame format
Frame Serial Length PDU type Data Check
header number
One byte One byte Two bytes Two bytes N bytes One byte
Frame header: The frame header is A5H, and the same bytes cannot appear in other fields in a frame; if
another field appears A5H, then a A5H byte is added thereafter. When the receiver is in resolution, the
receiver encounters a single A5H byte, which is considered as a synchronization header. It is
considered to be a data byte when it encounters 2 consecutive A5H bytes.
Serial number: The back end is filled at will, but the front end must have the same serial number in the
response frame
27
Length: PDU type field + total length of data field, NOT excluding synchronization head, serial
number and check
PDU type: see the second part
Data: See the second part
Check: Single byte X OR check algorithm, range of calculation: serial number, length, PDU type, data
2) PDU type and data
0x0001 Front end reset
0x0002 Read front end version
0x0003 Front end version
0x0010 Command is complete without the need to return data
0x0011 Command is complete, but an error has occurred
0x0101 Vibrating plate
0x0102 Switching filter
0x0103 Measuring air blank
0x0104 Air blank AD value
0x0105 Moving plate
0x0106 Moving plate ABS value
0x0107 Got AD value of last moving
0x0108 Moving plate AD value
0x0109 Voltage settings (0 lightson, 1 lights off)
0x010A Gets the light on & off time
0x010B Light on & off time
0x010C Read the serial number (ID)
0x010D Serial number
0x0118 Long time vibrating plate
3)Instruction sending and answering
Command Data Response Data Timeout time Other instructions
Reset 0x0010 15 seconds
Read front end 0x0003 4 bytes version 1 seconds 2 bytes motherboard, 2
version number bytes from board, BCD
code
Vibration plate 2 bytes (first 0x0010 Vibration time Vibration speed 1 slow,
byte vibration +6 seconds 2 medium, 3 fast
speed; second Vibration time 1—60
bytes vibration
time)
Switching 1 byte filter 0x0010 10 seconds
filters number (0—7)
Measuring air No 0x0104 The 16 bit air AD 1 seconds Data 16 bytes
blank value of 8 lines
Moving plate 1 byte vibration 0x0106 192 bytes, the 16 Continuous : 10 Data 192 bytes , all
test mode bit absorbance seconds values have been
(0:continuous 1: value of 96 wells Stepping : 30 expanded by 1000
stepping)△ seconds times
10005 means that the
absorbance is too large
28
10006 means that the
absorbance is too small
Moving plate 0x0108 208 bytes, the 16 1 seconds Need to perform
AD values bit AD value of 96 Moving plate test
wells + the 16 bit Instructions
air AD value of 8
lines

Switching 1 byte voltage 0x0010 1 seconds


voltage stall (0 or 1)
Light on & off 0x010B 1 byte voltage 1 seconds
time status, 2 bytes of
time
Read the 0x010D 9 bytes SN 1 seconds
unique
identification
number of the
SN machine
Long time 3 bytes (first 0x0010 Vibration time Vibration speed 1 slow,
vibrating plate byte vibration +6 seconds 2 medium, 3 fast
speed; second Vibration time 1—60
&third bytes
vibration time)
4)Error code
0x1201 Invalid filter number, valid: 0-7
0x1202 Invalid vibration plate time valid: 1-60s
0x1203 Invalid vibration plate speed, valid: 1-3
0x1204 Invalid moving plate mode, valid: 0、1
0x1205 Filter has no reset signal
0x1206 Elisa plate has no reset signal
0x1207 The elisa plate does not move or no positioning slot optical coupling signal
0x1208 AD does not have an OK signal
0x1209 Invalid voltage value ,valid: 0-1
0x120F Light source is too strong
0x1210 Light source is too weak

Section 13 Shut down


Back to the system's main interface, you can turn off the power supply directly.

Section 14 Instrument maintenance


14.1 Summary
The microplate reader is a precision clinical analytical instrument. To make the instrument keep a
good status, user must do routine maintenance well. Although maintenance of The microplate reader is
easy, user needs do it carefully.
14.2 Cleaning instrument
● Keep working condition of the instrument clean.
● User may use neutral clean solution and wet cloth to clean the instrument surface.
29
● User should clean LCD with soft cloth.

Note: Keep instrument away from dissolvent, oil and corrosive substance.

14.3 Instrument parts replacement


14.3.1 Replace fuses
1) Shut down power switch.
2) Fuses are equipped in fuse box which is back of instrument power switch. Users pull box lid and
replace fuses with same specification ones.
Fuse specification: 2-φ5×20 BGXP T 3.15AL 250V
3) Close the fuse box cover and restart the instrument.

Note: Users must use fuses of the above specification.

14.3.2 Replace halogen tungsten lamp


When halogen tungsten lamp is broken, replacement steps are as followings:
1) Shut down instrument and open instrument upper cover.
2) Unscrew the visor fixing screws and take off the light visor.
3) Unscrew the screw of the top spring retainer of which is fixed the lamp, remove the cushion, remove
the bulb, then pull the bulb from the lamp socket .
4) Install the new lamp and lamp socket (lamp type: OSRAM 64607, 8V/50W), reset the new lamp and
fix the spring cushion.
5) Return light visor and tighten screws.
6) Return upper cover and restart the instrument.

Note: The lamp must be purchased with the specified brand and model.

14.4 Simple fault handling


Phenomenon or hints Reason analysis Method
1 Bulb not lighting  Bulb power supply  Check whether supply
abnormal voltage is 8V
 Bulb broken  Replace bulb
2 Plate holder no  Plate holder position is too
 Push it to the left 1 cm gently
resetting signal on the right side
3 Built-in printer unable  Check whether printer
to start  Printer power is not normal power voltage is 5 V
 The press handle of built-in  Check whether the press
printer is not pressed handle of built-in printer is
pressed
4 Built-in printer unable  Whether setting printer  The printer type in the
to print type System Settings is set to
built-in printer or not
 Whether printer cable is  Printer 10 core cable is
connected well connected well or not
5 Instruments sometimes
 Data storage uninitialized  Click all clear in Data query
appear messy code
LCD screen brightness  Display contrast whether  Click on system settings to
6
is not enough adjusted adjust the contrast size
 Check whether the 7
 Connection of the control core signal control line on the
line is not good motor driver board is
Filter wheel no reset
7 connected well
signal
 Optical fiber head not fixed  Check whether optical
 Photoelectric coupler fault fiber head is loose
 Turn the filter wheel,
30
observe whether RT1 light
emitting diode on Data
Acquisition Board is change
from dark to bright, if there is
no change, change Filter
Wheel Positioning Detection
Plate
 Check whether
instrument is electrified

 Check whether the


power plug is loose
 Power supply is not  Check the fuse
normal
Instruments unable to  Switch machine time  Check the voltage
8
start interval is too short
 The motherboard does not  Shutdown after waiting
start more than 30s to restart

 Motherboard failure,
contact distributor or
manufacturers to change
the motherboard
 External printer connect  System setup>Set
9 External printer error
later Printer
 Open the machine cover,
check if the drive motor is
rotating
 Drive motor fault
10 Plate holder don’t move  On the data board,
 Plate holder reset error
Holzer components can not
connect the magnetic steel of
the plate holder
External printer unable  Printer power is not normal  Check if power plug is loose
11
to start  Check ON/OFF button
 Check if printer type is
setting correct
External printer unable
12  Printer setting is not correct  Check if print cable is
to print
normal connection
 If printer is setting normal
External printer appears  Replace the cartridge or
13 to fade, print quality  Printer problem ribbon, clean the print head
decline (see the printer user's manual)
External printer paper  (See the printer user's
14  Printer problem
jam and other faults manual)
 Check whether plate
holder transverse plate is
falling off, shifting
Plate holder positioning  Check whether 12
 Plate holder transverse
15 detection signal positioning grooves on the
position is not normal
abnormal transverse plate is blocked
 Check plate holder
positioning detection slot
coupler
Xxx wavelength air gap  Bulb broken  Replace bulb
16
is too low  Filter broken  Replace filter
 Check filter and filter wheel
Xxx wavelength air gap  Filter not properly installed
17 are properly installed
is too high  Filter broken
 Replace corresponding filter
Front end data  The serial line between  Reconnection 3 core serial
18
acquisition board is not front board and data line
31
responding acquisition board is loose  Reinstall the software's
 USB communication built-in USB drive
cannot identify USB
signals
 Not detected the plate
holder reset signal(Not
 Check the plate holder motion
necessarily signal error, it is
stroke length and force
Plate moving test possible that the distance is
19 condition
error too long) (The error is
 Check the position of slot
related to the position of
coupler
the reset signal and slot
coupler )
 In the Cut - Off
formula,calculated CO
value is 0;
 Or in the quantitative
formula, a standard ABS
value exceeds the range of
Plate moving test data  Check project setup and elisa
20 0.000-4.000;
error plate layout situation
 Or in the quantitative
formula, unable to get the
curve after calculation, for
example two different
concentrations of standard
ABS values are the same.
 Read the reagent user manual
 The concentration values of
carefully and understand the
Standard concentration multiple standard must be
21 interpretation of the
must be increasing increasing in the project
specification for standard
setup
solubility
 The quantity of standard
wells does not match with
 Carefully verify the number
the quantity of standard
of standard items in the
22 Standard layout error which is setted in the
reagent user manual
project in the number of
items set in the standard
quantity
 New projects do the plate
moving for the first
time,projects require setting  It is recommended that
contrast but layout do not the client set a negative and
Contrast plate
23 not set (If the project positive contrast well every
arrangement error
require there are negative time when they do the
contrast and positive experiment
contrast at the same time ,
layout must do both)
 Confirm that there is no
Negative control blank participation
24  Negative control value<0
absorbance too low calculation under the double
wavelength
 Check if foreign objects are
Negative control  Negative control value > stained with lenses, if the
25
absorbance too high 4.0 experiment fails,the solubility
of the sample is too deep
 Confirm that under the dual
Positive control wavelength there is not blank
26  Positive control value<0
absorbance too low to participate in the
calculation
 Check if foreign objects are
Positive control stained with lenses, if the
27  Positive control value>4.0
absorbance too high experiment fails,the solubility
of the sample is too deep
28 Cut-Off value error  Cut-Off value ≤0  Check if the qualitative

32
formula is wrong
 Confirm that there is no blank
Standard absorbance
29  Standard absorbance ≤0 participation calculation
too low
under the double wavelength
 Check if foreign objects are
Standard absorbance stained with lenses, if the
30  Standard absorbance ≥4.0
too high experiment fails,the solubility
of the sample is too deep
 Standard absorbance  Whether the test failed,
incorrect such as same whether the washing plate
31 Standard value error absorbance value of and adding sample is correct
standard with different and whether there is cross
concentration contamination

Note: In the use of the process if users can not solve the error, or a mistake is repeated,please contact the
seller.

33

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