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EN-103
ScanWatch
v1.0 | August, 2020
Regulatory statements
FCC ID: XNAHWA09
Electrocardiogram (ECG) recording, atrial fibrillation (AFib) detection & SpO2
measurement.
WARNINGS
A functional tester cannot be used to assess the accuracy of pulse oximeter
devices.
Misapplication of the ScanWatch with excessive pressure and for a prolonged
period can cause pressure injury.
Avoid using the ScanWatch on a wrist with poor skin integrity.
DO NOT sterilize using irradiation, steam or ethylene oxide. Refer to cleaning and
disinfection instructions.
Use of cleaning agents other than specified may damage the device.
DO NOT use the ScanWatch if it is damaged. Use of a damaged device could
cause patient injury or equipment failure.
DO NOT take recordings when ScanWatch is in close vicinity 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 external defibrillation procedures).
DO NOT take recordings when ScanWatch is outside of the operational
temperature range (5°C - 40°C).
indicated in the ScanWatch user manual and humidity range of 20% to 90%
relative humidity.
DO NOT use to diagnose heart-related conditions.
DO NOT use with a cardiac pacemaker, ICDs, or other implanted electronic
devices.
DO NOT take a recording during physical activity.
No modification of this equipment is allowed.
DO NOT modify this equipment without authorization of the manufacturer.
NOTES
The measurement of SpO2 in the 70-100% range has been clinically validated on
healthy adult volunteers, at rest, against a laboratory co-oximeter.
The device conforms to IP22 requirements.
This device has no alarm system in case of low saturation.
The Scan Monitor is intended for use in adults (18 years or older) and with no
restrictions on weight.
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