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.

Initial Setup 11
STEP 4
Wireless network (Wi-Fi) setting
Connect Wi-Fi
Select the Wi-Fi to connect to. When connected, the ‘
DONE
’ button
is
activat
ed.
T
ouch the
‘
DONE
’
b
utt
on.
Icon Connection Status Description
Connected Wi-Fi is connected and active.
Requesting Connection Please waitas the Wi-Fi signal is being acquired. In the case of
no response, touch ‘Reconnect Wi-Fi’ to try again
Connection failure Wi-Fi connection has failed.
Check wireless connection status or select other Wi-Fi.
Network not connected The icon indicates that Wi-Fi is not connected.
Select the ‘
Reconnect Wi-Fi
’ to connect in-range accessible Wi-Fi.
CelltrionUSAinc
CelltrionInc
CelltrionPharm
CelltrionHealthcare
CelltrionWelfare
CelltrionUSAinc
CelltrionSkincure

12 Initial Setup
7
STEP 5
Create Admin Password
Enter admin password Touch the ‘
OK
’ button
•
Administrator ID is automatically set as ‘Admin’.
•
Please set your own admin password.
•
Password is case-sensitive and must be a combination of
letters and numbers.
•
Yourpasswordcannotcontainspacesand must be less
than 45 characters long.
•
Touch theeye-shaped icon tocheck entered password.
STEP 6
Lock Setting
Establish QC Test settings according to each item Touch the ‘
OK
’ button
QC Lock On
•
In the case of when QC Test result shows ‘FAIL’,
the test is unavailable until the result shows ‘PASS’.
•
Conduct QC test regularly as scheduled, otherwise test
cannot berun.
QC Lock Off
•
A test can be run regardless of QC Test results.
QC Interval
•
On: A testcan only berun upon completionand passing
of the QC Test on the designated QC Test date
•
Off: Disables QC Test interval
•
Interval setting: SetupQCTestintervalwithin1to365days
7

Initial Setup 13
SAMPINUTE
STEP 7
Device Registration
a.
Enter hospital code in the window.
b.
After entering hospital code, touch the ‘DONE’ button to connect to hospital server.
c.
Once connected to server, initial setup is completed and the home screen will be displayed.
•
If there is no hospital code for device registration, touch the ‘Register device later’ button.
•
Device
registration
is
available
later in
[‘Settings’ ‘Device Registration’] (see Page 43).

14 Initial Setup
Barcode Scanner Connection
a.
Connect the barcode scanner to the USB Port on the back of SampinuteTM Analyzer.
b.
Barcode scanner automatically starts operation when connected to the USB port.
*Barcode scanner has to be purchased
separately.
Printer Connection
a.
Turn the printer on.
b.
USB Connection: The printer is automatically recognized once USB cable is connected.
c.
Bluetooth Connection: Please refer to
[Function settings
Printer
settings] (see Page 31).
*Printer is sold separately.

Running a Test 15
SAMPINUTE
5.
Running a Test
5-1. How to Perform RUN TEST
STEP 1
Touch the ‘RUN TEST’ button to start test
•
Run the test at a temperature range of 15-30°C (59-86°F).
•
If the temperature is out of range, the test cannot be run.
•
When the battery level is 15% or lower,you cannot start
the test.
•
Fully charge the battery before running a test.
STEP 2
Scan the operator ID
a. Scan the operator ID with the barcode scanner or manually enter the operator ID using the
keypad. Touch the ‘OK’ button only if entered manually.
If you do not have a barcode
scanner, touch the ‘
Input oper-
ator ID manually
’ to enter the
code using the keypad.

16 Running a Test
STEP 3
Scan the patient code
a.
Scan the patient code with a barcode scanner or manually enter the patient code using the
keypad. Touch the ‘OK’ button only if entered manually.
b.
The operator ID and the patient code are displayed on the screen. The screen subsequently
resumes to cartridge QR code scan.
If you do not have a barcode
scanner, touch the ‘
Input
patient code manually’
to
enter the code using the
keypad.
STEP 4
Scan the QR code of the test cartridge
a.
Scan the QR code on the cartridge pouch with the barcode scanner.
b.
After scanning the QR code, the cartridge type and LOT will be displayed on the screen.
•
The barcodescanner has to be purchased separately.
•
If QR code recognition fails, scan a new cartridge pouch.
•
Please check if the cartridge type of the cartridge is
correct.

Running a Test 17
STEP 5
Test cartridge insertion
a.
Remove the aluminium tape attached on top of the cartridge.
b.
Insert the test cartridge to the tray according tothe instructions on the screen.
c.
When the test cartridge is inserted in the correct position, the screen automatically proceeds
to the sample injection stage.
•
Make sure to check whether the correct operator and patient
codes are entered before scanning the QR code.
•
Ensure that the correct test cartridge is being used for the
target analyte.
•
Beforeinsertingthecartridge,ensurethatyouarenotusingan
already used one.
•
When the error message, “
Please contact the system
administrator
” is displayed after inserting the cartridge, stop
the processand contactthe administratortoresolve the issue.

18 Running a Test
STEP 6
Test sample injection and starting test
a.
Prepare a test sample.
b.
Before injecting the sample, check injection location of the test sample and whether a suffi-
cient amount of test sample is prepared.
c.
Inject the test sample within 2 minutes after inserting a cartridge.
d.
Touch the ‘OK’ button.
•
When the analysis starts, please wait until analysis reaches ‘100%’.
•
If the trayis not inserted intoanalyzer within 2 minutes afterinjected sample, start overwith a
new cartridge.
•
If an error occurs in waiting mode, inject more of the sample intothe cartridge inserted.
•
When an error occurs in analyzing mode, start over with a new cartridge.
•
Refer to the test cartridge package insert for details on how to draw test samples.

Running a Test 19
STEP 7
Check the result of the test
a.
When test is completed, the result of the test is displayed on the screen.
b.
Check the result and remove the cartridge from the tray.
c.
Touch the ‘
DONE
’ button Return to the home screen.
TEST RESULT
: Positive or Negative - Normal operation of test cartridge
If the warning sign is displayed as shown:
*warning:
unexpected signal detected.
,
a retest is
recommended.
STEP 8
Discard the used cartridge.
a.
Refer to the images below to eject the cartridge from the tray.
b.
DiscardtheSampinute™COVID-19AntigenMIAtestcartridgeafteruseasrequiredbyinternal
quality control procedures and in accordance with local, state and federal regulations or accred-
itation requirements.

20 Running a Test
5-2. Result Management
Check the results of the test.
The results can be checked by touching the ‘TEST RESULTS’ button on the home screen.
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