Kardia Band Instructions for use 2018

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

TROUBLE SHOOTING CAUTIONS After ECG analysis, the app may EQUIPMENT SYMBOLS
If you experience difficulties in operating your AliveCor products, refer incorrectly identify ventricular flutter, Serial number
to the troubleshooting guide below or contact technical support at General: ventricular bigeminy, and ventricular Model number
[email protected]. DO NOT store in extremely hot, cold, trigeminy heart conditions as European Authorized
humid, wet, or bright conditions. unreadable. Please consult with Representative
Problem: Solution: DO NOT expose to strong electro- your physician. Manufacturer
magnetic fields. CAUTION: AliveCor does not guar- Read instructions
My KardiaBand is not working. Option 1: Ensure that the Kardia DO NOT take recordings in close antee that you are not experiencing an before use
watch app has access to the watch’s vicinity to other equipment emitting arrhythmia or other health conditions Type BF applied part
microphone. On the iPhone, go to ultrasonic acoustics. when labeling an ECG as normal. You
Settings and tap the Kardia app. DO keep components out of reach should notify your physician for possi- Temperature range
Tap the microphone toggle. of children. ble changes in your health.
Option 2: Ensure that the watch DO use this device to record heart rate Humidity range
microphone is unobstructed. and heart rhythm only. KARDIABAND
Consult the watch user manual DO NOT use the sensor on portion SPECIFICATIONS Do not dispose with
if it is obstructed. of the body with too much body fat, Battery: CR1620 Coin Cell household waste
Option 3: Check and change the body hair or very dry skin, a successful Storage Conditions: Original ADDITIONAL INFORMATION
battery. Use a Torx T3 screwdriver recording may not be possible. package under normal room For more detailed troubleshooting
for the sensor battery door. AliveCor makes no warranty for any temperature and humidity and technical information, please visit:
data or information that is collected The KardiaBand sensor may be https://www.alivecor.com/
I have a lot of artifact, noise, or Option 1: Ensure that your watch, erroneously by the device, or misuse removed and inserted a maximum support/#user-manual
interference in my recording, or “No arms, and hands remain still during or malfunction as a result of abuse, of 50 times without performance
EKG recorded” message displays. recordings. accidents, alteration, misuse, neglect, degradation.
Option 2: Clean the electrodes on or failure to maintain the products as
the KardiaBand with an alcohol- instructed. Interpretations made by ELECTROMAGNETIC & OTHER
based sanitizer. this device are potential findings, not INTERFERENCES
Option 3: If your hands are very dry, a complete diagnosis of cardiac The KardiaBand has been tested
use a water-based lotion before conditions. All interpretations should and deemed in conformance with
recording. be reviewed by a medical professional the relevant requirements in
Option 4: When recording, relax your for clinical decision-making. IEC60601-1-2:2014 Class BF for
arms and hands to reduce muscle KardiaBand: Electromagnetic Compatibility (EMC).
noise. Rest the forearms and hands DO NOT use with a cardiac pacemak-
on a flat surface. er, ICDs, or other implanted electronic INGRESS PROTECTION
devices. MARKING
The ECG rhythms appear Option 1: The watch orientation may DO NOT continue use until further KardiaBand is IP64 rated. Kardia-
upside down. be set to the wrong wrist. On your instructed by a physician if your skin is Band is protected against insertion of
iPhone, go to the Watch app. Tap My irritated or inflamed around the sensor fingers and is not affected by vertically
Watch > General > Watch Orientation. or band. dripping water. KardiaBand has been
Option 2: The KardiaBand pieces DO NOT drop or bump with excessive tested with relevant requirement stan-
may be attached to the watch in the force. dard IEC60601-1-11:2015.
wrong orientation. Review “Assembly” DO NOT use to diagnose heart-
instructions. related conditions.
DO NOT expose the device to a mag-
netic resonance (MR) environment.
DO NOT wear during cautery and
external defibrillation procedures.