AliveCor Kardia Mobile Instructions For Use

INTENDED USE
Kardia Mobile (previously AliveCor
Heart Monitor) is intended to record,
store, and transfer single-channel
electrocardiogram (ECG) rhythms.
Kardia Mobile 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).
Kardia Mobile is intended for use by
healthcare professionals, patients
Kardia Mobile
with known or suspected heart
by AliveCor
®
conditions, and health-conscious
individuals. The product has not
Instructions For Use
been tested and it is not intended
for pediatric use.
USING KARDIA MOBILE
AliveCor, Inc.
444 Castro Street, Suite 600
1. Attach Kardia Mobile
Mountain View, CA 94041
to Your Phone (Optional)
United States
• Remove Kardia Mobile from
www.alivecor.com
the box.
Tel: 650-396-8650
AliveCor and Kardia are
trademarks and trade names
of AliveCor, Inc. in the United
States and other countries.
Sensors
(Electrodes)
Obelis SA
BD General Wahis 53
1030, Brussels
Belgium
• If you choose to attach Kardia
Mobile to the phone, adhere the
optional attachment plate to the
back of the phone.
0 1 2 3
Made in USA
02LB49 Revision 1 |
NOVEMBER 2016
• While holding the phone upright
NOTE: Kardia Mobile may be used up
to a distance of 30 cm (1 ft.) from the
smartphone or tablet. You have the
option of adhering it to the phone.
Battery Compartment
(battery included)
Front Back
2. Download Kardia App &
Create An Account
• On your compatible iOS or
Kardia Mobile Attachment Plate
• Open the Kardia app and follow
3. Recording Your First ECG
Do not use Kardia Mobile while
charging your phone.
Do not take a recording while driving
or during physical activity.
(camera at top), slide Kardia
Mobile into the attachment plate
so that the logo is pointing to the
right ">".
Top of Device
Android Phone (www.alivecor.
com/compatibility), download
the Kardia app from the App
Store or Google Play store.
the onscreen instructions to
create an account.
Do not take a recording if the elec-
trodes are dirty. Clean them first.
• Tap the Kardia app on your phone
to open the application.
• Rest two or more fingers on Kardia
Mobile; your right hand should
contact the sensor (electrode)
closest to the bottom of the smart-
phone, and your left hand should
contact the electrode closest to
the top of the smartphone.
• Rest your arms on a flat surface.
Remain still with your fingers on
the electrodes for 30 sec.
• Your first ECG is sent for analysis
(U.S. only).
Free medical
interpretation
of your first
ECG reading
For 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 smartphone or tablet
screen and you will not be able to
record any additional 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:
• Tap "Record now" on the
Standard EKG screen.
• Follow instructions for
"Recording Your First ECG."
• After ECG recording is
complete, the ECG is analyzed
to determine if it is at least 30
seconds long, if it is Normal,
Unclassified, possible Atrial
Fibrillation is present, or if it is
too noisy to interpret.
Presence of possible 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.
An Unclassified message means the
tracing is not Normal and not AF, and
interference was not detected. An
example of an Unclassified tracing is
one where tachycardia is observed.
Unreadable ECG results determines
that you didn't have proper ECG
recording for analysis. You may try
to re-record your ECG.
ECG reports viewed at any mag-
nification other than 100% may
appear distorted and could lead
to misdiagnosis.