Disclaimer: Due to health regulations and clearances, some ScanWatch 2 features may not be available or may not have clinical validation in your region. Learn more.
General precautions regarding usage
- Do NOT take recordings when the device is in close proximity to strong electromagnetic fields (e.g. X-Ray equipment, electromagnetic anti-theft systems, and metal detectors).
- Do NOT take recording during a medical procedure (e.g. magnetic resonance imaging (MRI), diathermy, and electrocautery).
- Do NOT use the Withings ECG App with a cardiac pacemaker, ICD, or other implanted electronic devices.
- Do NOT take an ECG recording while traveling on an airplane.
- Do NOT use the Withings ECG App if ScanWatch 2 is damaged. Use of a damaged device could
cause patient injury or equipment. - Do NOT take a recording during physical activity.
- Do NOT take recordings when the device is outside the operational temperature range and humidity range indicated in the device user manual.
- Keep the power cord away from children and pets, as it may cause a strangulation effect due to excessive length.
Factors and conditions impacting performance
-
Skin and contact factors: Excessive arm hair, or dry skin may interfere with electrode
contact and signal quality. Ensure skin is clean, and free of obstructions. -
Motion and activity: Movement, tremors, or vibrations can disrupt readings. Remain still,
seated, and avoid external vibrations during the measurement. -
Anatomical variations: Scars and tattoos may reduce electrode contact quality. Adjust the
wristband for a snug fit to optimize performance. -
Physiological conditions: Certain physiological conditions can prevent some people from
having a strong enough signal for the Withings ECG App to detect and analyze. - Pressure and Position: Ensure you are not applying too much force or pinching the watch when holding it with your other hand. Make sure to make contact with the metal of the watch but avoid the button if possible.
Disclaimers related to the Withings ECG App
- The Withings ECG App cannot check for signs of heart attacks or ischemic heart conditions. If
you experience chest pain, pressure, tightness or what you think is a heart attack, call
emergency services. If you believe you are having a medical emergency, call emergency services. - The waveform generated by Withings ECG App is meant to supplement rhythm classification for the purposes of discriminating Afib from sinus rhythm and high heart rate and not intended to replace traditional methods of diagnosis or treatment.
- Interpretations made by Withings ECG App are potential findings, and thus Withings ECG App cannot diagnose cardiac conditions.
- The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
- The Withings ECG App cannot detect all instances of Atrial Fibrillation. You should contact your physician if you experience any changes to your health.
- Do not self-diagnose or self-medicate on the basis of this device. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval of your physician.
- Withings ECG App is not intended to identify heart-related conditions other than Afib.
- Withings ECG App is not intended for use by individuals under the age of 22.
Regarding electromagnetic disturbances
This device complies with applicable electromagnetic compatibility (EMC) requirements to ensure performance in the presence of electromagnetic disturbances.
However, electromagnetic disturbances may cause temporary loss of function, degraded signal quality, or device interoperability. If this occurs:
- The device may fail to record or display ECG readings accurately.
- The user may receive a notification indicating an error or inability to record an ECG.
- Move the device to an environment free from electromagnetic interference (e.g., away
from active RF transmitters or industrial machinery). - Ensure all accessories and external equipment used with the device comply with EMC
requirements specified in the technical documentation. - Restart the device or reattempt the ECG recording after resolving interference.