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1. Product Introduction
1-1. Intended Use
The MARK-B™ 1 analyzer is an instrument that performs immunoassay on test cartridges. It reads specific biomarkers within the test sample.
1-2. Principle
The MARK-B™ 1 analyzer is an instrument based on an immunoassay technique called MESIA (Magnetic Electrochemical Sandwich Immunoassay). The MARK-B™ 1 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-antigen reactions and remove unbound magnetic nanoprobes. The MARK-B™ 1 analyzer measures
the concentration of any antigens or antibodies by detecting electrochemical signals from the reaction-completed magnetic nanoprobes. The MARK-B™ 1 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.
The MARK-B™ 1 analyzer is for use in IVDs.
The MARK-B™ 1 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.
The MARK-B™ 1 analyzer has been verified for overall safety, compatibility and compliance with the following AC/DC Adapter.
AC/DC Adapter : Adapter Technology Co.,Ltd., ATM030-Px
Rating : Input: 100-240 V a.c., 50-60 Hz, 0.7-0.45 A
Output: 12 V d.c., 2.5 A
The MARK-B™ 1 analyzer may also be used safely while connected to devices other than those recommended above.
The AC/DC adapter used with this device must comply with the minimum following requirements.
1. An AC/DC adapter complying with IEC 60950-1, IEC 61010-1, IEC 62368-1 or IEC 60601-1
2. An AC/DC adapter complying with Class I construction
3. An AC/DC adapter complying with the output rating: 12 V / 2.5 A
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 air vent when installing the device.
Take a precise amount of sample (in the case of using the reagent solution tube, insert 3 - 4 drops; in the case of using the micropipette, draw 100 μL) for each test and insert it into the sample
inlet at once.
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.
Turn off the power and remove the power adapter if you do not expect to use the analyzer for an extended period of time.
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 product to diagnose specific illnesses and conduct screening tests, such as neonatal screening.
Use the analyzer only to assist medical decision-making.
Keep this product out of the reach of children.
When discarding the analyzer, discard in a safe place in accordance with local regulations or accreditation requirements.
This test has not been FDA-cleared or approved;
This test has been validated internally by BBB and shall not be changed without prior concurrence from the FDA.
This test has been authorized only for the detection of antigens from SARS-CoV-2, not for any other viruses or pathogens.
1-4. Components
The following are the components you should check upon opening the package of the MARK-B™ 1 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.
Components provided in the box:
MARK-B™ 1 analyzer
Check Cartridge
User manual
Components not provided in the box:
Power adapter
Printer
Scanner
Control solutions
Test cartridges
Reagent solutions
Product Introduction
