Withings Scan Monitor Gebrauchsanweisung Seite 6

Scan Monitor
Altitude
1500-2500m
2500-3500m
3500-5800m
5800-7500m
5. TECHNICAL SPECIFICATIONS
Product Name
Model
ECG Sensor
SpO2 Sensor (Optical)
Operating conditions
Storage and transport conditions
Power Source
Wireless transmission
Measurement range (Heart Rate)
Oxygen Saturation Display range
Display
6. SAFETY AND PERFORMANCE
The Scan Monitor software's ability to accurately classify an ECG recording into Afib and sinus
rhythm was tested against the IEC 60601-2-47* standard and clinical data of 168 subjects.
The Scan Monitor demonstrated 98.16 % sensitivity in classifying AFib and 97.20 % specificity
in classifying sinus rhythm in classifiable recordings of 5 public databases.
Rhythm classification from Scan Monitor was compared to ECG labeled by cardiologist on the
clinical data. During this clinical study, 20.2% of recordings were inconclusive and not
classifiable as either sinus rhythm or AFib. The Scan Monitor reached 100.0 % sensitivity in
classifying AFib and 100.0 % specificity in classifying sinus rhythm among the remaining
Rev. 1.7 - Sep 12, 2023
Expected SpO2 value
(oxygen saturation in %)
>90
90
<90
<80
Scan Monitor
HWA09
3 stainless steel electrodes (Back case
electrodes and bezel electrodes) or
2 stainless steel electrodes (Back case
electrodes) & 1 Titanium Electrode (bezel
electrode) or
3 stainless steel electrodes coated with
TiCN/Au
Red light (wavelength is 655nm)
Infrared light (wavelength is 940nm)
+5°C to 40°C
20 to 90% Relative humidity
700-1060hPa
-25°C to 70°C
20 to 90%
3.6 Vdc Lithium ion battery
Wi-Fi and BLE
30bpm to 230bpm
70% to 100% (3% RMSE)
LED on the watch and in-app
Impact on human body
No altitude sickness
(normally)
Altitude sickness,
acclimatization recommended
Very frequent altitude
sickness, acclimatization
absolutely essential
Severe hypoxia, only limited
length of stay possible