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ECG Outputs
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Inconclusive
An Inconclusive result means that the
signal cannot be classified as Sinus Rhythm
or Atrial Fibrillation, although the quality of
the recording is good�
This may be due to various conditions,
including but not limited to other arrhyth-
mias or other heart conditions�
Talk to your doctor if you have questions
about your ECG recording�
Poor Recording
A Poor Recording result means the recording
quality is low and the ECG cannot be classi-
fied� This may be caused by errors during the
measurement� Some things that can cause
this type of result are: excessive movement
that causes a signal of poor quality; OR prox-
imity to an electrical device that generates
strong electromagnetic fields; not holding the
handle correctly; or not correctly positioning
your feet on the scale� A small percentage
of people may have certain physiological
conditions that prevent them from creating
enough signal to produce a quality recording�
You may try to re-record your ECG� You can
review how to take an ECG during setup or by
tapping Take a Recording in the ECG section
of the Health Mate app on your smartphone�
Sharing ECG Results
How to share your ECG with your doctor:
Once the ECG measurement feature is activated (see page 04
"Using Withings ECG Monitor with Withings Body Scan"), the
results of the ECG can be shared with a physician as a PDF,
generated by the Withings app�
The pdf includes the following information:
- The ECG strip for the 6 Leads
- The average heart rate
- The classification of the ECG according to the detection
algorithm�
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
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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