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.
When discarding the analyzer, discard in a safe place in accordance with the WEEE Directive
(2002/96/EC).
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1-2. Principle
MARK-B™ 1analyzer is an instrument based on an immunoassay technique called MESIA (Magnetic
Electrochemical Sandwich Immunoassay). MARK-B™ 1analyzer can be used to analyze asingle or
multiple analyte(s) by detecting electrochemical signals on the test cartridge, which is for aone-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™ 1analyzer measures the concentration of any
antigensor antibodies by detecting electrochemical signals from the reaction-completed magnetic
nanoprobes. MARK-B™ 1analyzer transmits the test data to the designated server via Wi-Fi.
1-3. Precautions &Warnings
Please read this user manual thoroughly for appropriate use.
MARK-B™ 1analyzer is for use in IVDs.
MARK-B™ 1analyzer and test cartridges are indicated for use in clinical laboratories.
Check that all components are present in the package.
Read this user manualbefore 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 afree distance of at least 10 cm (4 inches) from the face of the air vent 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.
Turn off the powerandremove the adapter if you do not expect to use the analyzer for an extended
period of time.
Do not use or store the product in alocation exposed to open flames.
Do not expose or store the product in alocation 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.
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 thereach of children.
In order to comply with radio frequency (RF) exposuer limits, antennas should be located at a
minimum of 20cm or more from the body all persons.
