Important Information Regarding Ecg Recordings - Withings ScanWatch Series Installation And Operating Instructions Manual

1 in 4 middle-aged adults in Europe & in the US will be diagnosed with AFib in
their lifetime. AFib-related US health spending exceeds $6 billion a year, or 1% of
the country's health expenditures.
What are the main risk factors?
Advanced age, high blood pressure, obesity, diabetes.
What are the possible treatments?
• Blood-thinning medication to prevent blood clots from forming and reduce
stroke risk
• Medications to control the heart's rhythm and rate
• Minimally invasive management—AFib ablation
How precise is ScanWatch's ability to detect AFib compared to ECG in a
hospital?
The capacity to detect AFib on ScanWatch was developed by cardiologists.
AFib detection in ScanWatch was compared to the gold-standard ECG used in
hospitals, and early results show a 98% success in identifying AFib episodes when
compared to a hospital ECG.

Important information regarding ECG recordings

• ScanWatch cannot check for signs of a heart attack. If you believe you are
experiencing a medical emergency, please call emergency services.
• Do not take recordings when ScanWatch is close to strong electromagnetic
fields (e.g. electromagnetic anti-theft systems, metal detectors).
• Do not take recordings during a medical procedure (e.g. magnetic resonance
imaging, diathermy, lithotripsy, cautery, and extremal defibrillation procedures).
• Do not take recordings when ScanWatch is outside the operating temperature
range (0° - 35°C) and humidity range of 20% to 95% relative humidity.
• Do not use ScanWatch to diagnose heart-related conditions.
• Do not use ScanWatch with a cardiac pacemaker, ICDs, or other implanted
electronic devices.
• Do not take a recording during physical activity.
• Do not change your medication without talking to your doctor.
• ScanWatch is not intended for use by individuals aged under 18 (21 in the US).
• You should talk to your doctor if your heart rate is under 50 bpm or over 120
bpm at rest and if this is an unexpected result.
• Interpretations made by the ECG software are potential findings, not a
complete diagnosis of cardiac conditions.
• The user is not intended to interpret or take clinical action based on
ScanWatch output with the consultation of a qualified healthcare professional.
• The waveform generated by ScanWatch is meant to supplement rhythm
classification for the purposes of discriminating AFib from normal sinus
rhythm and not intended to replace traditional methods of diagnosis or
treatment.
ScanWatch
v1.0 | August, 2020
EN - 65