Celltrion SAMPINUTE User manual

SAMPINUTE
TM
Analyzer
User Manual
Sampinute
TM
Analyzer (Immunoassay analyzer)
SampinuteTM Analyzer detects specific biomarker via immunoassay (MESIA; Magnetic Electro-
chemical Sandwich ImmunoAssay) from a small amount of test sample. SampinuteTM Analyzer
is intended to be used as an in vitro diagnostic medical device. Please read this user manual
thoroughly for correct use and keep it for future reference. For use under an Emergency Use
Authorization (EUA) only.

SAMPINUTE

Table of Contents
1. Product Introduction 4
1-1. Intended Use 4
1-2. Principle 4
1-3. Precautions & Warnings 4
1-4. Components 5
1-5. Symbol Guide 6
2. Product Description 7
2-1. SampinuteTM Analyzer 7
2-2. Check Cartridge 8
3. Screen Description 9
3-1. Home Screen 9
4. Initial Setup 10
5. Running a Test 15
5-1. How to perform RUN TEST 15
5-2. Result Management 20
6. Running a QC Test (Control Solution Test) 21
7. Function Setting 27
7-1. Setup Screen 27
7-2. Administrator Settings 28
7-3. Wi-Fi Settings 30
7-4. Printer Settings 31
7-5. Date & Time Settings 32
7-6. Lock Settings 34
8. Maintenance 36
8-1. System Check 36
8-2. Version Information and Update 40
8-3. Device Registration 43
8-4. Auto Power Off Settings 44
8-5. Cleaning 46
8-6. Storage Requirements 46
9. Error Messages 47
9-1. Notifications 47
9-2. Error pop-ups 50
10. Technical Information 56
11. Product Warranty 57

4 Product Introduction
1. Product Introduction
1-1. Intended Use
The SampinuteTM Analyzer is an instrument that performs immunoassay on test cartridges. It
reads specific biomarkers within the test sample.
1-2. Principle
Sampinute™ Analyzer is an instrument based on an immunoassay technique called MESIA
(Magnetic Electrochemical Sandwich Immunoassay). SampinuteTM Analyzer can be used to
analyze a single or multiple analyte(s) by detecting electrochemical signals on the test cartridge,
which is for a one-time in vitro diagnostic (IVD). The magnets within the device form magnetic
fields, which facilitate the interaction of nanoprobes in the test cartridge to induce antibody-an-
tigen reactions and remove unbound magnetic nanoprobes. The SampinuteTM Analyzer meas-
ures the concentration of any antigens or antibodies by detecting electrochemical signals from
the reaction-completed magnetic nanoprobes. SampinuteTM Analyzer transmits the test data to
the designated server via Wi-Fi.
1-3. Precautions & Warnings
Please read this user manual thoroughly for appropriate use.
Sampinute™ Analyzer is for use in IVDs.
SampinuteTM Analyzer and test cartridges are indicated for use in clinical laboratories.
Check that all components are present in the package.
Read this user manual before operating the analyzer.
The analyzer needs AC power connection to operate for an extended period of time and charge.
Please ensure your power supply is compatible with the analyzer’s power specifications.
Increasing the inner temperature activates the cooling fan inside the air vent.
Establish a free distance of at least 10 cm (4 inches) from the face of the airvent when installing the device.
Keep the air vent free from inflow of foreign substances.
Accidental entry of metals into the analyzer may cause breakdown or electric shock.
Please refer to product-specific package inserts included in each test kit for more information.
Turnoff thepowerandremovetheadapterifyoudonotexpecttousetheanalyzerforanextendedperiodoftime.
Do not use or store the product in a location exposed to open flames.
Do not expose or store the product in a location subject to high temperature and high humidity.
Prevent water and dust from entering the device.
Do not apply excessive force, drop or step on the product.
Aluminium tapes have been attached on the top of cartridges to help sustain the quality of the
cartridges. Only remove these tapes upon usage.
Avoid dropping the device while moving it.
Do not assemble or modify the analyzer.
The analyzer is not water-resistant. Do not wash it with water or touch it with wet hands.
Do not use the producttodiagnose specific illnessesand conductscreening tests, such as neonatal screening.
Use the analyzer only to assist medical decision-making.
Keep this product out of the reach of children.

Product Introduction 5
When discarding the analyzer,discard in a safe place in accordance with local, state and feder-
al regulations or accreditation requirements.
For use under the Emergency Use Authorization (EUA) only
When used with the Sampinute™ COVID-19 Antigen MIA:
This test has not been FDA cleared or approved; the test has been authorized by FDA under
an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that
meet the requirements to perform moderate or high complexity tests.
This test is only authorized for the duration of the declaration that circumstances exist
justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or
diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
1-4. Components
The following are the components you should check upon opening the package of SampinuteTM Analyzer.
Please check that all components are included in the box.
Please contact the purchase location if any of the following components are not included or damaged.
Sampinute
TM
Analyzer, 1EA
Check Cartridge, 1EA
User manual
Quick Reference Guide

6 Product Introduction
1-5. Symbol Guide
Please refer to the following symbols that can be found on the external package, package
descriptions, enclosed papers, etc.
Manufacturer
Date of Manufacture
Batch code
(for test cartridge)
Serial number
(for analyzer)
To indicate the humidity limitation in which
the transport package has to be kept and handled
Do not reuse.
(for test cartridge)
Caution, please refer to accompanying documents
Control
Waste electrical and electronic equipment (WEEE)
Prescription Use Only
Use by/Expiry date
(for test cartridge)
Catalogue number (for test cartridge)
To indicate the temperature limitation in which
the transport package has to be kept and handled
Biological risks
Please refer to user manual.
In Vitro Diagnostic Medical Device/In Vitro diagnostic use
Contains sufficient for <n> tests.
Important

Product Description 7
2. Product Description
2-1. Sampinute
TM
Analyzer
(1) Screen
Interface that the user can touch to operate the analyzer
and check the results.
(2) Power Button
Button to turn the device on or off.
(3) Tray (closed)
A component to insert the test catridge.
Opening and closing of the tray are controlled by the
software.
(4) Air vent
A component to control temperature inside the analyzer.
(5) Power supply connector
An adapter connection port to supply power to the device.
(6) USB port
A USB-A port for barcode scanner and mobile printer.
(7) Electrode connector for test cartridge
A connector for cartridge reading.
(8) Cartridge recognition switch
A switch to check cartridge insertion.
(9) Tray (open)
Thetrayisopenwiththecartridgeinserted.
(Component as closed status shown in (3))
9
7
8
4
6
5
1
2
3

8 Product Description
QR
Check
Cartridge
insert
2-2. Check Cartridge
The check cartridge is used to evaluate instrumental and electronic operations of the analyzer.
An alignment sensor is embedded in the check cartridge to check the alignment of magnets at
the top and bottom of the analyzer.
Cartridge contact pad
Contact pad forthe operation check of SampinuteTM Analyzer

Screen Description 9
3. Screen Description
3-1. Home Screen
(1) Status bar
Indicates SampinuteTM Analyzer’s network connection,
battery level and time.
(2) Status indicating icon
isdisplayedwhen QC test resultshows “fail”or
the QC test is not carried out.
is displayed when battery level is 15% or lower.
is displayed when temperature is either 15°C
(59°F) or lower, or at least 30°C (86°F).
is displayed when the first System Check is not
performed, or System Check result is Fail.
(3) Time
Displays day, date and month.
(4) Run test
Touch the button to start the test.
(5) QC Test
Touch the button to run the QC test.
(6) QC Test interval and test information
Check QC Test intervals and recent/next test schedule of
the QCtest
(7) Test results
Check all test results.
(8) Admin login / logout
Login to / logout of the admin account.
(9) Settings
Change settings. Check device information and update it.
1
2
3
4
5
6
7
8
9

10 Initial Setup
4. Initial Setup
STEP 1
Connect the power adapter.
STEP 2
Touch the ‘power’ button to start.
STEP 3
Time Zone setting
Touch the ‘ Select Time Zone ’ Select the time zone where the user is located.
* When setting is completed, touch the ‘DONE’ button.