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Indications For Use and Safety Information
Embrace2 is a wearable device, worn on the wrist of a child or adult, for use in home or in professional healthcare environments. Embrace senses electrodermal activity and motion data in order to detect patterns that may indicate a possible convulsive seizure in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert (or send an alarm) to a designated caregiver.
Limitations
- The device does not predict seizure onset.
- The device is not intended to be used during physical activity.
- The safety and effectiveness of the Embrace System has not been established in monitoring signals that may be associated with seizures other than generalized tonic-clonic convulsive seizures.
- The device is not intended to be used to guide medical therapy decisions.
Important safety information and risks
Empatica cannot guarantee that Embrace2 and the Alert App will detect every single seizure and deliver alerts accordingly. The system is not meant to substitute your current seizure monitoring practices, but rather to serve as a supplement in expediting first-response time. It is important to not alter current seizure management practices when using Embrace2.
The main risk associated with the Embrace2 and Alert App is the device failing to detect a convulsive seizure, or failing to deliver an alert due to connection issues. If the user or caregiver changes their seizure management practices and relies too heavily on Embrace2, this may lead to less than adequate supervision. Patients should discuss the risks and benefits of Embrace2 with their physician.
