Safety And Performance - Withings ECG MONITOR Instructions For Use Manual

12
Sharing ECG Results
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How to share your ECG with your doctor:
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Once the ECG measurement feature is activated (see page 04
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"Using Withings ECG Monitor with Withings Body Scan"), the
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results of the ECG can be shared with a physician as a PDF,
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generated by the Withings app.
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The pdf includes the following information:
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- The ECG strip for the 6 Leads
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- The average heart rate
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- The classification of the ECG according to the detection
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algorithm.
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How to enable ECG Measurement?
- First, make sure your Withings Body Scan is configured
properly and that you have activated Withings ECG Monitor by
following the tutorial in the Withings app.
- In order to activate or deactivate ECG measurement, go in
the settings tabs of the application and find your device and
select "Customize Screens."
- In the list you should be able to see "ECG 6-Lead." You can
select the measurement by tapping on it. A check mark will be
shown next to the measurement when activated.
- Please take into consideration that the scale will need to be
synchronized once before the change is applied to your device.
Performing an ECG measurement will apply the changes to
your device. If you don't perform an ECG measurement,
the changes will be applied to your device during a routine
synchronization overnight.

Safety and Performance

The Withings ECG Monitor contributes to an early detection of
atrial fibrillation, facilitates patient screening and helps physi-
cians treat the disease earlier and thus attenuates the impact of
the disease on the population. It also contributes to an increased
awareness of physiological conditions.
Withings ECG Monitor's ability to accurately classify an ECG
recording into Atrial Fibrillation and Sinus Rhythm categories
was tested in a clinical study.
Rhythm classification by Withings ECG Monitor was compared
to the review by cardiologists of simultaneously recorded 12-lead
ECG. The study included 233 patients. 90.3% of recordings were
conclusive (i.e. neither "inconclusive" nor "poor recording"). On
conclusive recordings, the sensitivity in classifying Atrial Fibrilla-
tion was 98% (lower bound of the 95% confidence interval: 92%)
and the specificity in detecting normal sinus rhythm was 100%
(lower bound of the 95% confidence interval: 98%).
The accuracy of heart rate measured from the ECG was also
assessed in this clinical study. The mean difference between the
algorithm calculated heart rate from Withings ECG Monitor's
strips and the heart rate measured by cardiologists on the 12-
lead ECGs was -1.1 bpm (standard deviation 3.3 bpm).
The performance of the ECG function passed the applicable
requirements on ECG waveform and heart rate measurements
specified in ANSI/AAMI/IEC 60601-2-47:2012 Requirements for
the Basic Safety and Essential Performance of Ambulatory Elec-
trocardiographic Systems and ANSI/AAMI EC57:2012 (R2020)
Testing And Reporting Performance Results Of Cardiac Rhythm
And ST Segment Measurement Algorithms.
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