AliveCor Mobile ECG, Руководство пользователя

Страница: 3 / 57

AliveCor, Inc. For support, please email support@alivecor.com or visit www.alivecor.com 3
1. PRODUCT DESCRIPTION
The AliveCor® Mobile ECG is a mobile, clinical-quality electrocardiogram (ECG) recorder. The
duration of the recording is established by the AliveECG App with a default setting of 30
seconds and a maximum time of 5 minutes. The software application can store thousands of
recordings on your smartphone or tablet and these recordings are also accessible to
authorized users on AliveCor, Inc. (AliveCor) servers (www.alivecor.com).
Patients with known or suspected heart conditions and health conscious individuals can use
the AliveCor Mobile ECG to record an ECG daily or whenever they are feeling symptoms,
and share their recordings with their physician. Medical professionals can use the AliveCor
Mobile ECG to quickly assess rate and rhythm, screen for arrhythmias, and remotely
monitor and manage their patients who use the AliveCor Mobile ECG.
The device consists of three components:
1. The Mobile ECG, which attaches to your compatible smartphone or tablet and has
electrodes to transmit ECG rhythms to the smartphone or tablet.
2. The
AliveECG
mobile application (
AliveECG
app) is used to collect, view, save, and
wirelessly transmit recordings to the AliveCor server.
3. A user-supplied compatible smartphone or tablet.
CAUTION: The AliveCor Mobile ECG has features that are only available to users who are
under the care of a physician. These features are available to prescription users only.
The Mobile ECG enables users to:

Collect and store single-channel ECG recordings using the smartphone or tablet.

Edit user information data associated with the recording.

Wirelessly transmit ECG recordings to the AliveCor server.

Access ECG recordings stored on the AliveCor server.

Print or save the recording in PDF format.

Request professional clinical interpretation and analysis of your ECG recordings.

Track events that may impact your heart health, such as symptoms, activities, diet,
activity, etc.
After a user has created an account on the
AliveECG
app and received an ECG analysis, the
Mobile ECG enables a user to:

View ECG recordings real-time and after the recording.

View the output of the Atrial Fibrillation, Normal, and Interference Detectors.
1.1. Indications for Use - US
The AliveCor Mobile ECG is intended to record, store and transfer single-channel
electrocardiogram (ECG) rhythms. The AliveCor Mobile ECG 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 AliveCor Mobile ECG is intended for use by
healthcare professionals, individuals with known or suspected heart conditions and
health-conscious individuals. The device has not been tested for and it is not intended