Empatica E4 - Intended Use and Users; Indication for Use Statement; User Types; User Modalities

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empaca
©
2015
INTENDED USE AND USERS
Indicaon for use statement
The E4 wearable sensor device is intended for use by either healthy individuals or paents under
a physician’s care for the connuous, non-invasive monitoring of blood volume pulse, peripheral
heart rate, electrodermal acvity, surface body temperature and physical acvity.
In healthy individuals, E4 device provides a means to capture and retrieve physiological data
useful in monitoring and maintaining health and well-being of the user.
When prescribed for a paent by a physician or other qualied healthcare professional, the
device is intended to capture physiological data that may be useful to the praconer in
monitoring basic vital signs, which may then prompt further monitoring using primary diagnosc
methods.
For example, the objecve physiological data that E4 collects can be examined by a physician or
clinician in the eld of epilepsy, to look for possible changes during dierent types of seizures,
such as generalized tonic-clonic seizures or complex paral seizures. Other experts in other elds
might examine the data provided by E4 to gain insights for their research in areas such as anxiety,
stress and sleep.
User types
• Paent – uses the device for a prolonged me and is being measured
• Operator - setup the work modality of the device and review the physiological data
User modalies
• Other the counter: The subject uses the E4 as a monitoring tool.
• Prescripon: A physician uses the device on a paent for monitoring its physiological data and
conducts studies on those data.