1. Product Introduction
1-1. Intended Use
The MARK-B analyzer is an instrument that performs immunoassay on test cartridges. It reads
specic biomarkers within the test sample.
1-2. Principle
The MARK-B analyzer is an instrument based on an immunoassay technique called MESIA (Magnetic
Electrochemical Sandwich Immunoassay). MARK-B 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 elds, which facilitate the interaction of
nanoprobes in the test cartridge to induce antibody-antigen reactions and remove unbound magnetic
nanoprobes. The MARK-B analyzer measures the concentration of any antigens or antibodies by detecting
electrochemical signals from the reaction-completed magnetic nanoprobes. MARK-B analyzer transmits the
test data to the designated server via Wi-Fi.
1-3. Precautions
●Please read this user manual thoroughly for appropriate use.
●The MARK-B analyzer is for use in IVDs.
●The MARK-B 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 specications.
●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.
●Keep the air vent free from inow of foreign substances.
●Accidental entry of metals into the analyzer may cause breakdown or electric shock.
●Please refer to product-specic package inserts included in each test kit for more
information.
●Turn off the power and remove the adapter if you do not expect to use the analyzer for an
extended period of time.
●Prevent water and dust from entering the device.
●Do not use or store the product in a location exposed to open ames.
●Do not expose or store the product in a location subject to high temperature and high
humidity.
●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 specic 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 the WEEE
Directive (2002/96/EC).
4
