Instructions for Use for KardiaMobile® (Model AC-019)
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Cautions
1. Detection of possible Atrial Fibrillation (AF) in your EKG results are not to be used for
diagnosis. If you are experiencing any concerning symptoms, contact your physician.
2. Result of "Bradycardia" or "Tachycardia" are designations of heart rate, not a clinical
diagnosis of an arrhythmia. Please consult with your physician should you receive
consistent identifications of "Bradycardia" or "Tachycardia".
3. “Unreadable” EKG results determines that you didn't have proper EKG recording for
analysis. You may try to re-record your EKG.
Indications For Use
The KardiaMobile® (Model AC-019) System is intended to record, store and transfer one- and
two-channel electrocardiogram (ECG) rhythms. In single channel mode, the KardiaMobile®
(Model AC-019) System can record Lead-I. In two channel mode, the KardiaMobile® (Model
AC-019) System can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar
limb leads aVR, aVF and aVL. The KardiaMobile® (Model AC-019) System also displays ECG
rhythms and output of ECG analysis from AliveCor’s KardiaAI platform including detecting the
presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The
KardiaMobile® (Model AC-019) System is intended for use by healthcare professionals, patients
with known or suspected heart conditions and health conscious individuals. The device has not
been tested and is not intended for pediatric use.
Terms
ECG:
Also known as an electrocardiogram, an ECG is a test that detects and records the
strength and timing of the electrical activity in your heart. This information is recorded on a
graph that shows each phase of the electrical signal as it travels through your heart.
Single-Lead ECG:
When the 2 top electrodes (Left Hand Electrode and Right Hand Electrode)
are used, the Kardia app will display a Single-Lead ECG that is comparable to Lead I on
standard ECG machines.
Six-Lead ECG:
When all 3 electrodes (Left Hand Electrode, Right Hand Electrode, and Left Leg
Electrode) are used, the Kardia app will display a Six-lead ECG that is comparable to Leads I, II,
III, aVF, aVL, and aVR on standard ECG machines. It is recommended that you record a Six-
Lead ECG (which provides more data to your cardiologist) when possible.
