Indication for use statement
The Empatica Health Monitoring Platform is a wearable health monitor
and paired mobile and cloud-based software analytics platform intended
to be used by trained healthcare professionals or researchers to
remotely monitor physiologic parameters in ambulatory users in
home-healthcare and professional healthcare environments.
The device supports continuous monitoring of**:
• Pulse Rate,
• Oxygen Saturation,
• Peripheral Skin Temperature, and
• Electrodermal activity
as well as intermittent monitoring of:
• Respiratory Rate, and
• Pulse Rate Variability
during periods without any motion.
Activity sensors are used to detect sleep periods and monitor the
activity associated with movement during sleep.
The Empatica Health Monitoring Platform can be used to analyze
circadian rhythms and assess activity in any instance where quantifiable
analysis of physical motion is desirable.
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