Withings BeamO Bedienungsanleitung Seite 15

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Safety and performance
Withings BeamO's ability to accurately measure temperature was validated based on the
requirements of the standards EN ISO 80601-2-56: 2017/A1 : 2020. In particular, a clinical
study was conducted and its accuracy in measuring temperature was validated compared
with a reference device.
The performance of the stethoscope function of BeamO was verified by two series of
tests. First, by testing the audio frequency range response (20Hz – 2kHz) and comparing
the results with a reference device. Second, by testing the Signal-to-Noise Ratio and Dy-
namic Range against a reference device on a variety of pre-recorded heart and respiratory
sounds.
Withings BeamO's ability to accurately classify an ECG recording into Atrial Fibrillation (AF)
and Sinus Rhythm (SR) categories were tested in a clinical study including 335 patients.
Rhythm classification by Withings BeamO was compared to the review by cardiologists
of simultaneously recorded 12-lead ECG. 86.5% of sct02's recordings were conclusive (i.e.
neither "inconclusive" nor "poor recording", and with a heart rate between 50 and 150
bpm). On conclusive recordings, the sensitivity in classifying Atrial Fibrillation was 100.0%
(lower bound of the 95% confidence interval: 98.1%) and the specificity in detecting nor-
mal sinus rhythm was 100.0% (lower bound of the 95% confidence interval: 98.5%). In
addition, Withings BeamO accurately classifies AF and SR into subgroups by heart rate
< or ≥ 100 bpm.
The mean difference between the algorithm calculated heart rate from Withings BeamO's
strips (median over 30 seconds) and the heart rate measured by cardiologists on the 12-
lead ECGs was -0.19 bpm (standard deviation: 1.42 bpm).
The quality of the ECG waveforms was assessed by the visibility and polarity of the P,
QRS and T waves. The accuracy of the 6 endpoints ranged between 97.9% and 100%. In
addition, the mean difference (standard deviation) for PR, QRS, and QT intervals was -0.5
(14.7) ms, -8.2 (19.7) ms, and 8.8 (18.8) ms respectively.
The performance of the ECG function passed the applicable requirements on ECG wave-
form and heart rate measurements specified in ANSI/AAMI/IEC 60601-2-47:2012 Require-
ments for the Basic Safety and Essential
Safety and performance
Performance of Ambulatory Electrocardiographic Systems and ANSI/AAMI EC57:2012
(R2020) Testing And Reporting Performance Results Of Cardiac Rhythm And ST Segment
Measurement Algorithms.
Withings BeamO's ability to accurately measure SpO2 and Pulse Rate via Photopletys-
mography (PPG) was validated in line with the standard EN ISO 80601-2-61:2019. In par-
ticular, a clinical study was conducted for SpO2 for comparison against a reference device,
and a bench test was performed for pulse rate accuracy. Regarding the SpO2 measure-
ment, the RMSE is below 2.5%. PPG Pulse Rate RMSE is below 3bpm.
- RF Statement
Medical Electrical Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the following.
Portable and mobile RF communication equipment can affect Medical Electrical Equip-
ment.
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