AliveCor KardiaMobile Card Gebruiksaanwijzing - Pagina 6

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Instructions for Use for KardiaMobile Card (AC-021)

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

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.

Pediatric use is defined as 21 years and under

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