AliveCor Mobile ECG, User Manual

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for pediatric use.
1.2. Indications for Use - OUS
The AliveCor Mobile ECG is intended to record, display, store and transfer single-
channel electrocardiogram (ECG) rhythms. The AliveCor Mobile ECG also detects the
presence of atrial fibrillation and normal sinus rhythm in each recording. The AliveCor
Mobile ECG is intended for use by healthcare professionals, patients with known or
suspected heart conditions and health conscious individuals.
1.3. Contraindications
There are no known contraindications for the Mobile ECG, although care should be
taken when considering using the device according to the warnings and precautions
below.
2. GENERAL SAFETY PRECAUTIONS

The device should not be used near water, or in a wet environment.

Do not use this unit in locations subject to high or low temperatures or humidity. It
should be used within the temperature and humidity range according to the product
label.

Do not sterilize this unit with an autoclave or glass sterilizer.

Audio and video products and similar equipment may cause interference. Please
stay away from such equipment when you are recording.

Do not take recordings in a location where the unit will be exposed to strong
electromagnetic forces, such as near an arc welder, high-power radio transmitter,
etc.

Signal quality may degrade by detecting signals from other ultrasonic acoustic
sources. Do not use the device in close vicinity to other equipment emitting
ultrasonic acoustics such as espresso machines, some ventilation systems or another
AliveCor Mobile ECG.

The smartphone or tablet power adapter may degrade signal detection. Do not use
the Mobile ECG while charging the smartphone or tablet.

Disperse any static electricity from your body before using the unit.

Do not take recordings in a moving vehicle.

Do not expose the unit to strong shocks or vibrations.

Do not disassemble, repair, or modify the unit.

Do not insert battery with polarity reversed.

Do not use batteries of a type other than that specified for use with the device.

Do not take a recording if the electrodes are dirty. Clean them first.

Do not use for any purpose other than obtaining an electrocardiogram.

If the portion of the body where the electrode is applied has too much body fat,
body hair or very dry skin, a successful recording may not be possible.

Some children and adults with very sensitive auditory ability may hear a high-
pitched hum or buzz emitting from the device when activated. This is due to normal