REMI SYSTEM SAFETY INFORMATION
Indications for use:
The REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI uses Epilog disposable Sensors – a single use, single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REMI-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing and reviewing of EEG on third-party software. REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professionals in a professional healthcare facility environment. Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).
The REMI System should not be used on any children under the age of 6 under any circumstances.
The REMI System should not be used on any patients who knowingly have a hypersensitivity to acrylics, silicones, and hydrogels.
Epilog sensors should not be placed on a patient’s scalp if there are open wounds at the Sensor target locations.