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Instructions for Use for KardiaMobile 6L
18. DO NOT expose the device to a magnetic resonance (MR) environment.
19. DO NOT use with a cardiac pacemaker, ICDs, or other implanted electronic devices.
20. DO NOT use during cautery and external defibrillation procedures.
21. DO NOT place electrodes in contact with other conductive parts including earth.
22. DO NOT use with un-approved accessories. Use of non-AliveCor approved accessories or
transducers and cables could result in electromagnetic emissions or decreased
electromagnetic immunity of this device and result in improper operation.
23. DO NOT use adjacent to or stacked with other equipment because it could result in
improper operation.
24. DO NOT use portable RF communications equipment (including peripherals such as
antenna cables and external antennas) closer than 30 cm (12 inches) to any part of the
KardiaMobile 6L System. Otherwise, degradation of the performance of the KardiaMobile
6L System could result.
Cautions
1. KardiaMobile 6L does not detect heart attack.
2. DO NOT change your medication without talking to your doctor.
3. 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.
4. Result of "Bradycardia" or "Tachycardia" are designations of heart rate in the absence of AF,
and are not to be used for diagnosis. Please consult with your physician should you receive
consistent identifications of "Bradycardia" or "Tachycardia".
5. "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 6L System is intended to record, store and transfer one- and two-channel
electrocardiogram (EKG) rhythms. In single channel mode, the KardiaMobile 6L System can
record Lead-I. In two channel mode, the KardiaMobile 6L System can record Lead-I and Lead-II
simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The
KardiaMobile 6L System also displays EKG rhythms and output of EKG analysis from AliveCor's
KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation,
bradycardia, tachycardia, and others. The KardiaMobile 6L 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.
Features & Functionality
KardiaMobile 6L is a 3-electrode personal EKG device that is capable of recording two kinds of
EKGs: a Single-Lead EKG and a Six-Lead EKG, which provides more data for you to share with
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