AliveCor Kardia - Indications for Use (U.S.); CAUTIONS; General Cautions

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 Request professional clinical interpretation and analysis of your EKG recordings.
 Track events that may impact your heart health, such as symptoms, activities, diet, etc.
After a user has created an account on the Kardia phone app and received an EKG analysis, the
Kardia Mobile and Kardia Band products enable a user to:
 View EKG recordings in real-time and after the recording.
 View the output of the Atrial Fibrillation, Normal, and Unreadable Detectors.
1.1. Indications for Use – U.S.
Kardia Mobile:
The Kardia Mobile product is intended to record, store and transfer single-channel
electrocardiogram (ECG) rhythms. The Kardia Mobile product 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 Kardia Mobile product is intended for use by
healthcare professionals, patients with known or suspected heart conditions and health
conscious individuals. The product has not been tested and it is not intended for pediatric use.
Kardia Band System:
The Kardia Band System is intended to record, store and transfer single-channel
electrocardiogram (ECG) rhythms. The Kardia Band 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 Kardia Band System is intended for use by healthcare
professionals, adult patients with known or suspected heart conditions and health conscious
individuals.
1.2. Clinical Testing
Kardia Band System was extensively tested in clinical studies. Overall, 41 volunteers over 18
years of age participated in the Kardia Band System study, where Lead I recordings were
compared between the Kardia Band System and a standard FDA-cleared 12-lead device.
Clinical equivalence of the recordings from the two devices was validated by two Board
Certified Cardiac Electrophysiologists.
1.3. Contraindications
There are no known contraindications for the Kardia Mobile or Kardia Band System products,
although care should be taken when considering using the device according to the warnings
and precautions below.
2. CAUTIONS
General:
 DO NOT store in extremely hot, cold, humid, wet, or bright conditions.
 DO NOT expose to strong electromagnetic fields.