Intended Use And Users; Indication For Use Statement; User Types; User Modalities - Empatica E4 User Manual

INTENDED USE AND USERS

Indication for use statement

The E4 wearable sensor device is intended for use by either healthy individuals or patients under
a physician's care for the continuous, non-invasive monitoring of blood volume pulse, peripheral
heart rate, electrodermal activity, surface body temperature and physical activity.
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 patient by a physician or other qualified healthcare professional, the
device is intended to capture physiological data that may be useful to the practitioner in
monitoring basic vital signs, which may then prompt further monitoring using primary diagnostic
methods.
For example, the objective physiological data that E4 collects can be examined by a physician or
clinician in the field of epilepsy, to look for possible changes during different types of seizures,
such as generalized tonic-clonic seizures or complex partial seizures. Other experts in other fields
might examine the data provided by E4 to gain insights for their research in areas such as anxiety,
stress and sleep.

User types

• Patient – uses the device for a prolonged time and is being measured
• Operator - setup the work modality of the device and review the physiological data

User modalities

• Other the counter: The subject uses the E4 as a monitoring tool.
• Prescription: A physician uses the device on a patient for monitoring its physiological data and
conducts studies on those data.
6
empatica 2015
©