Withings ECG MONITOR Instructions For Use Manual page 3

Intended Use (Non-US Regions)
The Withings ECG Monitor is a software-only device intended for use
with the Withings Body Scan to create, record, store, transfer and
display lead II and lead-III of a two-channel electrocardiogram (ECG).
In addition, it calculates and displays leads I, aVR, aVF, aVL.
The Withings ECG Monitor determines the presence of atrial fibrilla-
tion (AFib), sinus rhythm, and high heart rate (no signs of AFib but a
sinus rhythm with heart rate between 100-150 bpm) on a classifiable
waveform. The Withings ECG Monitor is not recommended for users
with other known arrhythmias.
The Withings ECG Monitor is intended for over-the-counter (OTC)
use. The ECG data displayed by the Withings ECG Monitor is intend-
ed for informational use only. The user is not intended to interpret or
take clinical action based on the device output without consultation
of a qualified healthcare professional. The ECG waveform is meant to
supplement rhythm classification for the purposes of discriminating
AFib from sinus rhythm and is not intended to replace traditional
methods of diagnosis or treatment.
The Withings ECG Monitor is intended for use by an adult population.
Contraindications
DO NOT use the Withings ECG Monitor with a cardiac pacemaker,
ICD, or other implanted electronic devices.
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