WARNING: To properly use this medical device, read and comply with these
instructions for use
CAUTION: USA Federal law restricts this device to sale by or on order of a physician
Intended use
The Empatica Health Monitoring Platform is intended for the remote
monitoring of physiological parameters, whose variation could not result
in immediate danger to the patient.
The Empatica Health Monitoring Platform is intended to be used in
ambulatory users* in healthcare facilities and home settings.
The Empatica Health Monitoring Platform is intended for the
retrospective review of the collected physiological parameters.
The Empatica Health Monitoring Platform is not intended to be used by
acutely ill cardiac patients with the potential to develop life-threatening
arrhythmias or to be used in high-acuity environments such as an ICU or
operating room.
*Users' minimum age varies based on the country. The minimum is 2 years and up in the EU, and 18
years and up in the US.
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