1.

Turn on STANDARD M10 Console and STANDARD M10 Module. 2. After confirm the calibration test information, touch the OK
EN M10-CAL-01
2. Check that STANDARD M10 Console and STANDARD M10 button on the pop-up window. (Touch the Reset button to re-
Module are connected and functional. input the information.)
3. Enter the User ID and Password on the Log In screen of

Calibration Kit
STANDARD M10 Console and click the Log In button.

STANDARD™ M10 Calibration Kit

PLEASE READ INSTRUCTIONS CAREFULLY

BEFORE YOU PERFORM THE TEST

EXPLANATION AND SUMMARY

■ STANDARDTM M10
STANDARD M10 is an in vitro diagnostic system that measures
quantitative or qualitative biomarkers of human specimens
using real-time PCR or real-time LAMP. STANDARD M10 is an
automated system that integrates extraction and amplification
of nucleic acids from various specimens and detection of target
sequences. STANDARD M10 is designed exclusively for the use of
SD BIOSENSOR STANDARD M10 assay applications. STANDARD
M10 consists of STANDARD M10 Module and STANDARD M10
Console. The entire testing process is carried out inside STANDARD
M10 Module, and STANDARD M10 Console controls the process,
Figure 5. Confirmation pop-up window
analyzes the result and manages the database using the software.
■ STANDARD TM
M10 Calibration Kit Figure 1. Log In screen 3. Calibration starts automatically, and remaining time will
STANDRAD M10 Calibration Kit is one of the important components appear on the screen.
to verify the STANDRAD M10 system hardware functionality. It can 4. Touch STANDARD M10 Module 1 on the Home screen. (The door
make sure if this STANDARD M10 works properly as doing this of STANDARD M10 Module 1 will automatically open for cartridge
procedure. Calibration check is a required function that checks loading.)
the internal analyzer optics and calculations system. STANDARD
M10 Module requires calibration check after every 1,000 tests.
One calibration cartridge is used to calibrate all STANDARD M10
Modules connected to one STANDARD M10 Console.

INTENDED USE
STANDARD M10 Calibration Kit is designed to check the
functionality of optical system of STANDARD M10.

KIT CONTENTS
No. Contents Quantity
1 Cartridge 2
2 Instructions for use 1

MATERIALS REQUIRED BUT NOT PROVIDED Figure 6. Running screen Figure 7. Home screen while
Calibration is running
STANDARD M10 with User Manual at least one STANDARD M10
Console and one STANDARD M10 Module.
4. When the run is finished, it switches to the Review screen and
KIT STORAGE AND STABILITY the result is displayed. After checking the ‘Valid’ result, touch
Figure 2. Home screen
Store STANDARD M10 Calibration Kit at 2~28℃(36~82℉). If the the Home icon ( ) and repeat the process.
cartridge has been refrigerated, perform the test after stabilizing it
5. Scan the STANDARD M10 Calibration cartridge to be used
for 30 minutes at room temperature (20-28°C, 68~82℉). Cartridges
in ‘Sample ID’ step. STANDARD M10 Console automatically
can be used until the expiration date printed on the label.
recognizes the M10 Calibration Kit to be run based on the
cartridge barcode. (If the ‘Patient ID’ option is on, scan the M10
WARNINGS AND PRECAUTIONS Calibration Kit in ‘Patient ID’ step.)
1. This kit is only for calibration of STANDARD M10 instrument.
2. Please read the Instructions for Use carefully before testing.
3. Discard cartridges that have been removed from their foil-
wrapped pouches outside of the approved usage interval.
4. Do not add the improper reagent to the STANDARD M10
Calibration Kit. It may cause a problem with SATANDARD M10
instrument.
5. Do not remove the Safety Clip of the cartridge before use.
6. Do not press the cartridge until actual use.
7. Do not use a cartridge that has leaked or is wet.
8. Do not shake, tilt, or invert the cartridge especially after
pressing the cartridge to punch the seal. It may yield non-
determinate results.
9. Do not use a cartridge with a damaged barcode label.
10. No sample is required for this calibration kit.
11. Discard used cartridges once the STANDARD M10 Calibration
process is completed. Figure 8. Calibration Result of Module 1
12. Follow your institution’s environmental waste procedures for
proper disposal of used cartridges. 5. Touch the module 2 to run on the Home screen. (The door of
STANDARD M10 Module will automatically open for cartridge
PROCEDURE loading.)
■ Starting the STANDARD M10 system Figure 3. Sample ID screen
• When the warning message to run the calibration test popped
up with the calibration symbol at the top of the screen, it is time ■ Running test
to calibrate STANDARD M10. 1. Load the cartridge on the selected STANDARD M10 Module
• Calibration symbol will disappear when the calibration test is with the Amplification chamber facing the inside of the
done. module. (The status indicator of the selected module will blink
• Calibration can only start from M10 Module 1, and one cartridge green.)
can calibrate all modules connected to one console.
• If you have scanned the cartridge barcode in the STANDARD
M10 and the software version is not compatible, a ‘Not
Supported Device’ error message appears. Update the software
before proceeding with the test.
• For the detailed instructions, refer to the STANDARD M10 User
Manual.

Figure 9. Home screen of calibrate Module 2

Figure 4. Insert Cartridge screen

A4 / 모조 70g / CMYK 4도 / 접지 사이즈 : 105x75

M10_Calibration Kit_IFU_L28MC3ENR0_20220630-4.indd 1 2022-06-30 오후 5:45:52

 STANDARD™ M10 Calibration Kit

6. Load the cartridge on the selected STANDARD M10 Module 9. When calibration is completed for all modules, ‘Calibration SYMBOL
with the Amplification chamber facing the inside of the Completed’ window will appear on the screen.
module. (The status indicator of the selected module will blink Consult Instructions for
green.) Cat. No. Catalogue Number Reference number
In vitro Diagnos�cs
Consult
foruse
Use
Instruc�ons Contains Sufficient
for <n> Tests

To indicate the temperature limita�ons in

In Vitro diagnostic
Consult Instruc�ons
for Use
Contains Sufficient
for <n> Tests Cau�on Do not re-use. Use by
which the transport package has to be
kept and handled.
Cat. No.
Batch code
Catalogue Number
Batch code medical
Manufacturer
In vitro device
Diagnos�cs
Consult Instruc�ons
Date of manufacture
for Use

To indicate the temperature limita�ons in Fulfill the requirements of

which the transport package has to be Direc�ve 98/79/EC on in vitro diagnos
Contains Sufficient Manufacturer
Manufacturer
Date of manufacture
Date of manufacture medical devices
for <n> Tests Cau�on Do not re-use. Use by kept and handled. Batch code

To indicate the temperature limita�ons in

Cat. No. Cat. No. Consult Instruc�ons Contains
Contains Sufficient for
Sufficient
Consult Instruc�ons Contains Sufficient
Temperature limit
which the transport package has to be
Catalogue Number In vitro Catalogue
Diagnos�cs Number for Use In vitro Diagnos�cs for <n> Tests for Use Cau�on Do not
<n> Tests
re-use.
for <n> Tests Use by Cau�on kept and handled. Do not re-use. Batch code Use by

Doin not use if

To indicate the temperature limita�ons packaging
Cat. No. Consult Instruc�ons Contains Sufficient Use-by date which the transport package has to be
Catalogue Number In vitro Diagnos�cs for Use for <n> Tests Cau�on Do not re-use. Use by kept and handled. is damaged Batch code Manu

Caution Keep dry

Note Keep away from sunlight

Figure 13. Calibration Completed window
Authorized
CE marking - European
Figure 10. Insert Cartridge screen representative in the
Conformity
European Community
7. Calibration starts automatically, and remaining time will
appear on the screen.

Figure 14. Home screen Figure 15. Review screen

EXAMPLE OF RESULTS
Results are interpreted automatically by the STANDARD M10
Console and are clearly shown in the pop-up screen; calibration
Figure 11.Running screen Completed or Failed. STANDARD M10 Calibration provides test
results based on the optical performance of STANDARD M10
Modules.
8. Repeat [Running test] steps 4. to 7. to run calibration for the
remaining modules. Result Example

Calibration Completed;
Calibration Completed STANDARD M10 get a verification.
It makes your results get convincing.

Calibration Failed;
STANDARD M10 are not verified.
Calibration Failed
Please ask to the manufacturer or distributing
agency.

LIMITATIONS
For use only with STANDARD M10 instrument (running Console
software version “V001.010” and above).
Use of STANDARD M10 Calibration Kit does not guarantee that
STANDARD M10 instrument will be free of hardware failures, or
does it take the place of a M10 Service Agreement.

Figure 12. Repeat the Calibration run for

the remaining M10 Modules.

Manufactured by SD Biosensor, Inc.

Head office : C-4th&5th, 16, Deogyeong-daero
1556beon-gil, Yeongtong-gu,
Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA
Manufacturing site : 74, Osongsaengmyeong
4-ro, Osong-eup, Heungdeok-gu, Cheongju-si,
Chungcheongbuk-do, 28161, REPUBLIC OF KOREA

Authorized Representative

Altenhofstrasse 80, 66386 St. Ingbert Germany

Phone : +49 6894 581020, Fax : +49 6894 581021

Please contact us for any complaints/inquiries/suggestions

via email (sales@sdbiosensor.com),
phone (+82-31-300-0400) or website (www.sdbiosensor.com).

L28MC3ENR0
Issue date: 2022.06

M10_Calibration Kit_IFU_L28MC3ENR0_20220630-4.indd 2 2022-06-30 오후 5:45:53