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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 L) 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.
Product Introduction
3
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