Instructions for Use for KardiaMobile Card (AC-021)
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28. Do not use adjacent to or stacked with other equipment because it could result in improper
operation.
29. 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
Card System. Otherwise, degradation of the performance of the KardiaMobile Card System
could result.
30. Do not take a recording during physical activity.
31. After EKG analysis, the app may incorrectly identify ventricular flutter as “Unreadable”.
Contact a physician if you are experiencing any symptoms or have concerns.
Indications For Use
The KardiaMobile Card System is intended to record, store and transfer single-channel
electrocardiogram (ECG/EKG) rhythms. The KardiaMobile Card 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 Card 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
1
.
Features & Functionality
KardiaMobile Card is a personal EKG device that is capable of recording a Single-Lead EKG. It
has two electrodes on the top surface and is powered by a non-replaceable battery. Bluetooth is
used to wirelessly transmit EKG data from the device to your smartphone or tablet.
What is an EKG?
Also known as an electrocardiogram or ECG, an EKG is a test that detects and records the
strength and timing of the electrical activity in your heart. Each heartbeat is triggered by an
electrical impulse. Your EKG represents the timing and strength of these impulses as they travel
through your heart.
Single-lead EKG
A Single-Lead EKG is the simplest way to record your heart rhythm. It measures a single view
of the heart. It is taken by laying the device on a flat surface near your smartphone and placing
fingers from the left and right hand on the top two electrodes of the device. This is comparable
to Lead I on standard EKG machines used in the hospital or doctor’s office.
1
Pediatric use is defined as 21 years and under
