AliveCor KardiaBand System Инструкция по применению
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Печатать страницуINDICATIONS FOR USE
The KardiaBand System is intend-
ed to record, store and transfer
single-channel electrocardiogram
(ECG) rhythms. The KardiaBand
System also displays ECG rhythms
and detects the presence of atrial
fibrillation and normal sinus rhythm
(when prescribed or used under the
care of a physician). The KardiaBand
System is intended for use by health-
care professionals, adult patients
with known or suspected heart
conditions and health conscious
KardiaBand System
individuals.
by AliveCor
®
Instructions For Use
AliveCor, Inc.
444 Castro Street, 6th Floor
Mountain View, CA 94041
USING KARDIABAND
United States
1. Assembly
www.alivecor.com
Tell: 650-396-8650
• Remove KardiaBand from the box.
• Remove existing watchband from
• Attach both KardiaBand pieces to
Obelis SA
BD General Wahis 53
1030, Brussels
Belgium
Made in China
band
15LB1 Revision 5 |
NOVEMBER 2017
your Apple Watch.
the watch – the electrode piece
attaches to the 6 o'clock side of the
watch body. Choose the band that
ensures a tight fit so that the sensor
contacts the skin.
electrodes (sensor)
2. App set up
• On your iPhone, download
the Kardia app from the
App Store.
• Open the Apple Watch
app on your iPhone and
tap the My Watch tab.
• Scroll to find the Kardia watch app
and tap it.
• Tap the "Show app on Apple
Watch" toggle to turn on each
feature.
• On your iPhone, tap the Kardia
app and follow the on-screen
instructions.
3. Recording an ECG
NOTE: These instructions are specific
for those who wear their Apple Watch
on their left wrist. If you wear your
watch on your right wrist, follow the
instructions by swapping left and right.
• Tap the Kardia watch app on
the Apple Watch to open the
application.
• In the in-app tutorial, swipe the
screen right to left to view the
instructions.
• With your right hand, grasp your
left hand. Rest your right thumb
on the outer electrode on the
KardiaBand. Push your right thumb
with enough force to ensure that the
inner electrode is in contact with the
skin of your left wrist for the entire
duration of the recording. Remain
still while recording – your watch,
forearm, and hands should not
move while recording.
• Do not use KardiaBand while
charging your watch.
• Do not take a recording while driving
or physical activity.
• Do not take a recording if the elec-
trodes are dirty. Clean them first.
• Wrist hair may affect the perfor-
mance of the device. We recom-
mend removing excess hair from
your wrist.
• Tap the "Record" button. Ensure
that your hands and fingers are in
the proper position.
• The recording takes 30 sec.
• After 30 sec, you have the option to
Save or Cancel the recording.
Free medical interpretation
of your first ECG reading in
the United States only.
A U.S. board-certified cardiologist
will automatically review your first
recording for free and will provide
a medical interpretation of your
ECG within 24 hours. Due to FDA
regulations, the heart rhythm for your
first recording will not be visible on
your mobile device screen and you
will not be able to record any addi-
tional ECGs while the cardiologist is
preparing your report. After you receive
your report notification email, you will
be able to record and view as many
ECGs as you like.
4. ECG Analysis
Subsequent recordings:
• After an ECG recording is complete,
the ECG is analyzed to determine
if it is at least 30 seconds long, if
it is Normal, Unclassified, if Atrial
Fibrillation is present, or if it is too
noisy to interpret.
• Tapping the analysis result displays
a description of the result.
• To view the ECG, use the digital
crown or swipe the screen right
to left.
• Presence of Atrial Fibrillation (AF)
in your ECG results may present
only potential findings. If you are
experiencing any symptoms or have
concerns, contact your physician.
• Normal results mean your heart
rate is between 50 and 100 beats
per minute, and shape, timing and
duration of each beat is considered
normal.
CAUTION: AliveCor does not
guarantee that you are not experi-
encing an arrhythmia or other health
conditions when labeling an ECG
as normal. You should notify your
physician for possible changes in
your health.
• Unreadable ECG results determines
that you didn't have proper ECG
recording for analysis. You might try
to re-record your ECG.
• ECG reports viewed at any mag-
nification other than 100% may
appear distorted and could lead
to misdiagnosis.
• All ECGs are synced to the Kardia
phone app. You may use the
phone app to send your ECGs for
physician analysis.
CLINICAL TESTING
KardiaBand was extensively tested in
clinical studies. Overall, 41 volunteers
over 18 years old participated in the
KardiaBand studies, where Lead I
recordings were compared between
KardiaBand and an FDA-cleared 12-
lead device. Clinical equivalence of
the recordings from the two devices
was verified by two Board Certified
Cardiac Electrophysiologists.