AliveCor KardiaBand System Instructions For Use

Browse online or download pdf Instructions For Use for Heart Rate Monitor AliveCor KardiaBand System. AliveCor KardiaBand System 2 pages.

Print Page

INDICATIONS 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.