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PRODUCT DESCRIPTION
The MESI mTABLET ABI is an automated wireless ankle-brachial
index measuring system for screening patients for Peripheral Arterial
Disease (PAD/LEAD). The system is intended to perform (and make
viewable and storable) adult ankle-brachial index (ABI) measurement.
It is a wireless system which is comprised of a wireless medical
tablet system, four tubeless blood pressure cuff modules and a
4-port charging station module.
MESI mTABLET ABI is intended to be used solely in a professional
healthcare environment by trained healthcare personnel which
can correctly place blood pressure cuffs on a patient’s body, verify
that these cuffs are inflating or deflating normally and start the
measurement process.
MESI mTABLET ABI is intended to measure the Ankle-Brachial
Index by using a type of oscillometric method plethysmogra-
phy. The Ankle-Brachial Index result (along with blood pressure
values used in calculating the ABI), pulse wave and oscillation
graph are captured and displayed as a numerical and graphical
representation on the MESI mTABLET UNIT.
With standard software, the MESI mTABLET ABI supports an
automatic two-step measurement of systolic, diastolic and mean
arterial blood pressure on both upper arm and ankle locations.
The first part of the measurement performs a dual arm blood
pressure measurement while the second part of the measure-
ment performs a simultaneous ABI measurement considering
the higher of the two arm blood pressures and both ankle blood
pressures.
2.2 INTENDED USE
The MESI mTABLET ABI users must be adequately trained to use
device. Before the first use of the device, users must carefully read the
entire instructions for use and follow the Instructions for Use in full and
follow the Instructions for Use for connected equipment.
ACCESSORIES
2.1.1