OPERATOR MANUAL

IRE96, ELISA Microplate reader

SFRI sarl - Berganton - 33127 Saint Jean d’Illac – France

Tel : +33 (0) 556 688 050 Fax : +33 (0) 556 217 903
e-mail : contact@sfri.com
OPERATOR MANUAL

Contents

Statement 3
1. Installation 5
1.1. Unpacking 5
1.2. Installation Environment Requirements 5
1.3. Connection 5
2. Function 6
2.1. Introduction 6
2.2. Rear View 6
2.3. Front View 6
3. Operation 7
3.1. Power-on 7
3.2. Main Menu 7
3.3. Measure 7
3.4. Program 8
3.5. Quality Control 13
3.6. Setup 13
3.7. Service 15
3.8. Rapid Measure 16
4. Maintenance 17
4.1. Notice 17
4.2. Maintenance 17
5. Technical Specifications 18
6. Troubleshooting 19
7. Warning 20

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Statement
SFRI sarl owns all rights to this unpublished work and intends to maintain this work as confidential.
SFRI sarl may also seek to maintain this work as an unpublished copyright. This publication is to be
used solely for the purposes of reference, operation, maintenance, or repair of SFRI sarl equipment.
No part of this can be disseminated for other purposes.

In the event of inadvertent or deliberate publication, SFRI sarl intends to enforce its rights to this
work under copyright laws as a published work. Those having access to this work may not copy, use, or
disclose the information in this work unless expressly authorized by SFRI sarl to do so.

All information contained in this publication is believed to be correct. SFRI sarl shall not be liable for
errors contained herein nor for incidental or consequential damages in connection with the furnishing,
performance, or use of this material. This publication may refer to information and protected by
copyrights or patents and does not convey any license under the patent rights of SFRI sarl, nor the
rights of others. SFRI sarl does not assume any liability arising out of any infringements of patents or
other rights of third parties.

Content of this manual is subject to changes without prior notice.

Responsibility on the manufacturer party

SFRI sarl is responsible for safety, reliability and performance of this equipment only in the condition
that:
• all installation, expansion, change, modification and repair of this equipment are conducted by
SFRI sarl qualified personnel;
• applied electrical appliance is in compliance with relevant National Standards;
• the Analyzer is operated under strict observance of this manual.

Warning
For continued safe use of this equipment, it is necessary that the listed instructions are followed.
However, instructions listed in this manual in no way supersede established medical practices
concerning patient care.
z This equipment is intended for use only by medical professionals in health care institutions.
z To avoid electrical shock, you shall not open any cover by yourself. Service must be carried
out by qualified personnel.
z It is dangerous to expose electrical contact or applicant coupler to normal saline, other liquid
or conductive adhesive. Electrical contact and coupler such as cable connector, power supply
must be kept clean and dry. Once being polluted by liquid, they must be thoroughly dried. If
to further remove the pollution, please contact your biomedical department or SFRI sarl.

It is important for the hospital or organization that employs this equipment to carry out a reasonable

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OPERATOR MANUAL

maintenance schedule. Neglect of this may result in machine breakdown or injury of human health.

Upon request, SFRI sarl may provide, with compensation, necessary circuit diagrams, calibration
illustration list and other information to help qualified technician to maintain and repair some parts,
which SFRI sarl may define as user serviceable.

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING WARRANTIES OF MERCHANT ABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Workmanship & Materials

SFRI sarl guarantees new equipment other than accessories to be free from defects in workmanship
and materials for a period of one year from date of shipment under normal use and service. SFRI sarl's
obligation under this warranty is limited to repairing, at SFRI sarl’s option, any part which upon SFRI
sarl's examination proves defective.

Exemptions

SFRI sarl's obligation or liability under this warranty does not include any transportation or other
charges or liability for direct, indirect or consequential damages or delay resulting from the improper
use or application of the product or the substitution upon it of parts or accessories not approved by
SFRI sarl or repaired by anyone other than a SFRI sarl authorized representative.

This warranty shall not extend to any instrument which has been subjected to misuse, negligence or
accident; any instrument from which SFRI sarl's original serial number tag or product identification
markings have been altered or removed, or any product of any other manufacturer.

Safety, Reliability and Performance

SFRI sarl is not responsible for the effects on safety, reliability and performance of the IRE96 if:
■ Assembly operations, extensions, re-adjusts, modifications or repairs are carried out by persons
other than those authorized by SFRI sarl.
■ Personal unauthorized by SFRI sarl repairs or modifies the instrument.

Company Contact
Address: SFRI sarl
Berganton
33127 SAINT JEAN D’ILLAC
FRANCE
Phone: +33 (0) 556 688 050
Fax: +33 (0) 556 217 903
e-mail afss@sfri.com
IRE96 Operator Manual (V1.1) 4/19
OPERATOR MANUAL

1. Installation

1.1 Unpacking
When you receive your IRE96, carefully unpack the package and check the device. If you see any
damages, file a claim immediately with your local distributor or our local agency.
Put away the packaging material for future use.
Check the IRE96 and accessories against the packing list. If you find anything missing or
unconformable, please contact our local distributor or local agency.

1.2 Installation Environment Requirements

1.2.1 Transportation and Storage
• Ambient temperature -20 - 55℃
• Relative humidity ≤93%
• Atmospheric pressure 50 - 106 kPa

1.2.2. Operation Environment

The IRE96 should be free of dust, vibration, corrosive and flammable gas, interference by strong
current and magnetic field as well as direct sunlight. Moreover, enough space should be kept behind
the device for good ventilation.
• Ambient temperature: 10 - 40℃
• Relative humidity: ≤85%
• Atmospheric pressure: 86 - 106kPa
• Power requirements: AC 220V, 50/60Hz

1.3 Connection :
Check if the voltage conforms to requirements of the device. Make sure the power jack is grounded
correctly; otherwise you should connect a single ground wire to the Grounding port on the device.
Connect the printer to the Printer port on the device through a data cable.
Insert one end of the power cord into the Power Jack on the rear panel of the device and other end to
the power supply.

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2. Function

2.1. Introduction
The IRE96 Microplate Reader is an 8-channels optical measuring system, which can be used to measure
the density of vertical light. It is a specialized analyzer to hold ELISA and then take readings and
process data.
The IRE96 adopts the touch screen which is comfortable to operate.
With the advanced high speed microprocessor in the world and man-machine conversation design on
the software, the IRE96 makes the operation simpler and more convenient, result calculation quicker
and waiting time of operator much shorter.

2.2. Rear View (Figure 1)

Printer Port Serial RS232 Port Power Jack Power On/Off Grounding

Figure 1

2.3. Front View (Figure 2)

Touch Screen
Sample Figure 2
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3. Operation

3.1 Power-on
When you switch on the power, the device will begin self-check and then enter the Main Menu screen
(Figure 3) if everything is normal. After powering on the device, you should wait 10m for it to preheat,
so that each component and the lamp within the device become steady.

Jan.18,2005
Main Menu
18:18:18

Measure Program

Quality Control Setup

Service Rapid Measure

Figure 3

3.2 Main Menu

The Main Menu displays the function keys and current date and time. You can enter the submenu
screen by touching corresponding function key.

3.3 Measure
Touch the Measure button, the Select Test screen as shown in Figure 4 is displayed. Touch Pgdn to
display the tests of other pages circularly (42 tests in total, 3 pages). Touch the Exit button to return
to the Main Menu.

Measure Select Test

01 HBsAg 02 HBsAb
03 HBcAg 04 HBcAb
05 06
07 08
09 10
11 12

Pgdn Exit

Figure 4 Select Test screen

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After you select the tests, the Plate No. and Vibrancy screen (Figure 5) is displayed.

Plate No. 00

Vibrancy

Exit OK
Figure 5 Plate No. and Vibrancy screen

Touch Plate No. and enter the Plate No. in the Plate No. screen (Figure 6). As shown in figure 6, the
CLR button is to delete what you have entered. After entering, touch YES to confirm and return to
the Plate No. and Vibrancy screen. If you touch Exit, then the Plate No. is 00. Touch OK to begin
measuring and analyzing the ELISA plate. If you need to mix the sample by vibrating the plate before
measuring, touch Vibrancy and then the OK button.

Plate No. ____________

1 2

3 4

5 6

7 8

9 0

. -

YES CLR

Exit
Figure 6 Plate No. screen

3.4 Program
The Program screen includes Edit Test, New Test and Delete Test (Figure 7). Touch Exit to return to
the Main Menu.
Program

Edit Test

New Test

Delete Test

Exit
Figure 7 Program screen

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3.4.1 Edit Test

Touch Edit Test to select the test that you want to edit (Figure 4), then enter the Edit Test screen
(Figure 8).
Note: After setting, touch OK to save your settings.

Edit Test HBsAg

Prim. Wav. 405nm

Sec. Wav. 630nm

Plate Layout

Calculation Mode

Exit OK
Figure 8 Edit Test screen

Touch the Prim. Wav. button, a menu will then appear to ask you to select the wavelength. Please
select as instructed by the package insert.

NOTE: Don’t close all the filters; otherwise the alarm message “Lamp L” will appear.

Touch the Sec. Wav. button, a menu will then appear to ask you to select the wavelength. Please
select as instructed by the package insert.
In the Plate Layout screen (Figure 9-1), the right column is for selecting the well position you want to
set, use the and buttons to select different well columns. The
box on top right corner displays the current strip being set. Touch Exit to return to the screen as
shown in figure 8.

Automatic A01 Blank 01

B01 Pos. Control 01
C01 Sample 01
D01 Sample 02
E01 Sample 03
F01 Sample 04
Exit G01 Sample 05

H01 Sample 07
Figure 9-1 Plate Layout screen
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After selecting the well position, the screen as shown in figure 9-2 will be displayed. The left column
is for setting the filling type and filling No. of the selected well position (Sample: 1-96; Standard: 1-10;
Quality Control: 1-10; Neg./Pos. control: 1-12; Blank well: 1-12), use the Pgdn button to view each No.
of filling type. Touch the selected well position once more to exit its filling, refer to A01 in figure 9-2.

Standard 01 A01 Blank 01

Quality Control 01 B01 Pos. Control 01

Neg. Control 01 C01 Sample 01

Pos. Control 01 D01 Sample 02

Blank 01 E01 Sample 03

Sample 01 F01 Sample 04

Pgdn G01 Sample 05

H01 Sample 07

Figure 9-2 Plate Layout Menu

You can set the sample position quickly by using the button Automatic as shown in figure 9-1. Since
this function sets No. only for the original sample wells or blank wells, you should touch Delete All
(Figure 10) to delete all settings of the well positions before auto filling. Then enter the Blank,
Standard and Quality Control, etc, touch Automatic and select Hor. Strip or Ver. Strip and No. of wells
that you want to repeat.

Hor. Strip

Ver. Strip

Delete All

Exit
Figure 10 Automatic screen

Touch the Calculation Mode button as shown in figure 8, then select a method in the list appeared.
1. Absorbance: Read the absorbance of the sample directly, no submenu is displayed.
2. Qual Calculation: You should set Qual Grouping, Cut-off, Neg. Range, Pos. Range, Validity
Confirm and so forth. Please make settings as instructed by the package insert.
a. Qual Grouping 1-4: You can divide the qualitative results into four groups (Negative-,

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Positive+, Weak Positive-+ and Strong Positive ++) in accordance with the cut-off you
have set.
b. Cut-off 1-3: Enter values of a, b and c in the CutOff formula : (a x NC)+(b x PC)+c.
Where,
NC - Absorbance of the negative control well
PC - Absorbance of the positive control well
c. Neg. Range: When the absorbance exceeds the required range, the device will
calculate automatically with the negative control limit you have set.
d. Pos. Range: When the absorbance exceeds the required range, the device will
calculate automatically with the positive control limit you have set.
e. Validity Confirm 1-3: Set the range of absorbance for blank wells, positive and
negative control wells. The device will not calculate results when the absorbance
exceeds the range.
3. Quant Calculation: Some parameters are added on the basis of qualitative settings, such as
STD Concentration, Unit, Reference, Calibration Rule and Factor. Please make settings as
instructed by the package insert.
a. STD Concentration: You can set the concentrations of up to 8 standards. When setting,
you should begin with 1 from low concentration to high concentration. If No. of
standards is less than 8, you must set the remaining concentrations to 0.
b. Unit: Enter the concentration unit of the selected test.
c. Reference H: Enter the upper limit for the selected test.
d. Reference L: Enter the lower limit for the selected test.
e. Calibration Rule (C - Concentration, A - Absorbance, k - Slope, b - Intercept)
• Factor
Formula: A =kC +b.
k and b should be entered by the operator manually.
• One Point Linear
Formula: A =kC,
This calibration rule requires only one standard to obtain the parameter k.
• Two Point Linear
Formula: A =kC+b
A2-A1 A2-A1
K= b = A1 –( )C1
C2-C1 C2-C1

This calibration rule requires two standards. C1 and C2 are concentrations of

standard 1 and 2; A1 and A2 are their absorbance.
• Multipoint Linear
Formula: A =kC+b.
You can get values of k and b through the method of least squares.
This calibration rule requires at least 3 standards.
• Nonlinear
Draw a broken line passing through the standard concentration and its absorbance.

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Measure the absorbance of the waiting samples and check relevant concentration
on the broken line.
This calibration rule requires at least 3 standards.
• Multipoint Percent
The maximum absorbance of the standards is 100%.
This calibration rule requires at least 3 standards as the multi-point broken line.
• Exponent
Formula : A = k x lnC +b
This calibration rule requires at least 3 standards.
• Logarithm
Formula: A = kebC
This calibration rule requires at least 3 standards.
• Power function
Formula: A = kCb
This calibration rule requires at least 3 standards.
f. Factor Setup: Enter the calibration parameters k and b which are mainly used in the
factor calculation method.

3.4.2 New Test

Touch the New Test button to select the test that you want to add or modify (refer to figure 4 for
Select Test screen), and then enter the New Test screen (Figure 11).

New Test _____________

1ABCabc 2DEFdef
3GHIghi 4JKLjkl
5MNOmno 6PQRpqr
7STUstu 8VWXvwx
9Yzyz +-*/
0.,() NEXT
YES CLR

Exit
Figure 11 New Test screen

In the New Test screen, if you touch a button repeatedly, the screen will display the next number,
letter or symbol in circular way. NEXT is used to move the cursor rightward to enter the next
character. If you enter a wrong character, delete it with the CLR button and enter again. Touch YES to
save what you have entered and Exit to return to the Program screen (Figure 7) without saving your
entering.

3.4.3 Delete Test

Touch the Delete Test button, select the test that you want to delete (Figure 4).

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3.5. Quality Control

Touch the Quality Control button, select the test that you want to view (Figure 4), then the QC plot of
this test will be displayed (Figure 12.). Touch the Settings button to set the QC parameters of this test
(V - Mean, SD - Standard Difference). If you want to print the QC data and QC plot, touch the Print
button.

hAFP Quality Control V： 0.000 SD：0.000

+3S

+2S

Settings Delete Data

Print Exit

Figure 12 QC Plot screen

After touching the Delete Data button, you need to select Del. Last Month or Del. All Data, as shown
in figure 13. Touch Exit to return to the screen as shown in figure 12.

Del. Last Month

Del. All Data

Exit
Figure 13 Delete Data screen

3.6. Setup
In the Setup screen (Figure 14), you can set the date and time, vibrant speed, light source, printer
and filter.
Setup

Date and Time Vibrancy

Light Source Printer

Filter
Exit
Figure 14 Setup screen
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3.6.1. Date and Time

Touch the Date and Time button to set Year, Month, Day, Hour and Minute one by one. Touch YES to
confirm your settings and proceed to the next option until you finish all settings.

3.6.2. Vibrancy

The Vibrancy screen (Figure 15) includes Vibrant Speed and Vibrant Time. There are three speeds
available as High, Normal and Low. The vibrant time should not be longer than 60s.

Vibrant Speed Normal

Vibrant Time 30s

Exit
Figure 15 Vibrancy screen

3.6.3. Light Source

This button is used to turn on/off the lamp temporarily for the sake of the lamp’s lifespan.

NOTE: The lamp should be turned on and preheats for 10m before testing; otherwise the alarm
message “Lamp L” will appear.

3.6.4 Printer

This button is used to power on/off the printer, so you can select whether to print the results
immediately after testing.

3.6.5 Filter

The IRE96 reads the air blank absorbance of each filter in the 4 channels (F5 is spare), which is used
to check the photometric system. The default absorbance of the 405 - 630 filters is less than 0.500.
However, it may increase gradually in the result of dust, humidification and moldiness when the
device is used for a long time. If the absorbance is greater than 1.000, you should clean the
photometric system or replace the accessories like the filters.

3.7 Service
There are three options in the Service menu:
9 Data Transfer
9 Result Review
9 Standard Review

3.7.1 Data Transfer

Touch the Data Transfer button to transport the test data to the computer which is connected to the
IRE96 through the serial RS232 port.
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3.7.2 Result Review

Touch the Result Review button and enter the No. of Plate that you want to search, then touch YES to
display the results. Touch the button to display circularly the results of column 0-6 and
7-12.

3.7.3 Standard Review

After touching the Standard Review button and selecting the test that you want to search, the screen
will display the standard absorbance and relevant concentration, as well as the calibration curve, as
shown in figure 16. However, if the selected test doesn’t use the Quant Calculation Mode, the results
will not be displayed).

Standard Review hAFP

Concentration Absorbance ABS
1 1.0 1.000
2 2.0 2.000
3 3.0 3.000
4 4.0 4.000
5 5.0 5.000
6 6.0 6.000
7 7.0 7.000
8 8.0 8.000
k 1.000
b 0.000
Multipoint Linear STD
Exit

Figure 16 Standard Review screen

3.8 Rapid Measure

This function is used to read the absorbance of the waiting samples quickly.
After touching the Rapid Measure button, select the primary and secondary wavelength and enter the
No. of sample. Touch OK to start testing (Figure 17).

Prim. Wav. 450nm

Sec. Wav.

Vibrancy

Exit OK
Figure 17 Rapid Measure screen

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4. Maintenance

4.1 Notice
To ensure reliable performance and excellent operation of the IRE96, the operator must operate and
maintain strictly as instructed by this Operation Manual.

4.2 Maintenance
The IRE96 Microplate Reader is a precision optical measuring system. Therefore, it’s necessary to
perform the daily maintenance, which includes:
• Keeping the operating environment dry and clean.
• Covering the sample compartment after using to prevent from dust.
• Keeping the mechanical and electrical parts of the device away from water and reagents.
• Switching off the power supply while cleaning the surface and screen of the device.
• Be sure to use soft cloth with non-corrosive detergent.

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5. Technical Specifications

9 Wavelength: Accuracy (±2nm), Half width (≤12nm), Peak transmittance (≥35%).

9 Wavelength range: 405 nm, 450 nm, 492 nm, 630nm. 4 free positions for optional filters
9 Reading range: 0 - 3.5A, Measurement range: 0 - 2.5A
9 Absorbance resolution: 0.001A (Internally: 0.0001A)
9 Absorbance accuracy: ±0.03A (0 - 2.5A)
9 Repeatability (CV, %) ≤1%
9 Linearity: Error requirements

Wavelength Range (nm) Absorbance (A) Linearity Error %

405 - 630 0.0 - 2.5 ≤ ±2.5%

9 Stability: ≤ 0.005A/10min
9 Reading Speed: Single wavelength <20s/plate (96-well plate); dual wavelength <35s/plate
(96-well plate).
9 Vibrancy: Vibrant Speed (High, Normal, Low); Vibrant Time (0 - 60s).
9 Power: 100VA

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6. Troubleshooting
Symptoms Causes Actions to Take
Can’t start up The power cord is not connected Re-connect the power cord
correctly properly
The fuse is broken Replace the fuse

No display, no backlight The LCD display or inverter goes
wrong
The sample compartment The optical coupler is with dust
works abnormally or goes wrong
The sample compartment is
Sound is abnormal during blocked
operation Foreign matter exists
Mechanical movement is
abnormal
Can’t print The printer is not connected
properly
Readings are abnormal The lamp is aging or goes wrong
The filter is aging or goes wrong
The electric circuit goes wrong
Contact our local distributor or
local agency
Remove the dust and replace the
optical coupler
Reposition the ELISA plate
Remove the foreign matter
Contact our local distributor or
local agency
Check the connection between
the printer and the device
Replace the lamp
Replace the filter
Contact our local distributor or
local agency

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7. Warning
The IRE96 is a mini in vitro diagnosis instrument. It may bring risks to the patients indirectly, and
accompanying risks to the operator and environment. To avoid these risks, be sure to read the
following instructions carefully.

This device adopts AC 220V which may bring electrical harm to human body. Don’t open the

rear cover before switching off the power supply. If you need to open the rear cover to maintain the
device, you’d better contact our service personnel or professionals.

For the patient samples may contain germina or virus which will cause disease, be sure to

dispose of the waste in accordance with relevant regulations of your hospital.

NOTE: Don’t operate the device unless you have read this Operation Manual carefully.

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