Edwards Acumen IQ Finger Cuff Bedienungsanleitung

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English

Acumen IQ Finger Cuff
ClearSight Finger Cuff
AIQCS, AIQCM, AIQCL, CSC2S, CSC2M, CSC2L
Carefully read these instructions for use,
which address the warnings, precautions,
and residual risks for this medical device.
Description
The Acumen IQ and ClearSight finger cuffs, when
used with an appropriate Edwards monitoring
system, provide continuous, noninvasive
hemodynamic monitoring. The Acumen IQ and
ClearSight finger cuffs utilize the volume-clamp
method to measure blood pressure with an
inflatable bladder wrapped around the middle
phalanx of the finger.
Device performance, including functional
characteristics, have been verified
Edwards, Edwards Lifesciences, the stylized
E logo, Acumen, Acumen IQ, ClearSight, EV1000,
and HemoSphere are trademarks of
Edwards Lifesciences Corporation. All other
trademarks are the property of their respective
owners.
DIRECTORY
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Acumen IQ and ClearSight Finger Cuff
in a comprehensive series of testing to support
the safety and performance of the device for its
intended use when used in accordance with the
established Instructions For Use
The ClearSight system provides continuous blood
pressure measurement in a non-invasive manner.
Indications
The Acumen IQ and ClearSight finger cuffs are
indicated for patients over 18 years of age to
noninvasively measure blood pressure and
associated hemodynamic parameters when used
with EV1000 clinical platform NI or HemoSphere
advanced monitoring platform.
Contraindications
In some patients with extreme contraction of the
smooth muscle in the arteries and arterioles in
the lower arm and hand, such as may be present
in patients with Raynaud's disease, blood pressure
measurement can become impossible.
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Single Patient Use
The Acumen IQ and ClearSight finger cuffs are
designed for single patient use. Upon starting
measurement, the finger cuff can be used and
re-applied for up to 72 hours on one patient. After
8 hours of continuous monitoring on a single finger,
the finger cuff should be re-applied to another
finger.
Do not attempt to clean and reuse the finger cuff
on more than a single patient.
Warnings
Improper placement, sizing, or alignment
of the finger cuff can lead to inaccurate
monitoring.
Do not apply the finger cuff on injured skin as
this may cause further injury.
To reduce the risk of skin irritation and tissue
damage, do not monitor longer than 8 hours
continuously on a single finger. To continue
to monitor beyond 8 hours, use an additional
CC1095