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INTENDED FOR U.S. AUDIENCES ONLY

Instructions for Use for REMI™ and REMI Vigilenz™ AI

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REMIMAGINE

With groundbreaking technology and the only truly wireless system, REMI™ is creating new possibilities beyond what seemed possible in EEG monitoring

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Powered by REMI Vigilenz™ AI for Event Detection

SEE HOW REMI WORKS IN DIFFERENT SETTINGS

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ACCURATE

Provides accurate high-fidelity EEG recordings

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Wireless icon

WIRELESS

Allows patients to move freely without wires

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Fast icon

FAST

Enables EEG monitoring to be initiated within minutes

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FAMILIAR

Transmits data to Persyst™ Mobile, the most common EEG monitoring platform, to be reviewed remotely by a healthcare professional

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Easy to Use icon

EASY TO USE

SYNC, SET, and START

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REIMBURSABLE

The REMI Remote EEG Monitoring System is reimbursable using preexisting codes

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REMI PROVIDES RAPID EEG MONITORING IN HEALTHCARE FACILITIES

REMI provides the accuracy you need for electrographic seizure detection with easy application and high-fidelity EEG recordings that can be reviewed in near real-time.

With a truly wireless system and only 4 sensors, your patients will be comfortable during monitoring and can move freely throughout the facility.

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Ambulatory female patient

RESHAPE THE WORLD OF AMBULATORY MONITORING 

With REMI Ambulatory monitoring, you have the flexibility to monitor patients for an extended period of time, allowing for more time to detect potential events.

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ADVANCED TECHNOLOGY, BETTER EXPERIENCE

REMI Vigilenz AI for Event Detection is groundbreaking technology that helps identify potential electrographic seizure activity. Annotations are made within the EEG record that include potential detected events along with their corresponding confidence level and duration.

Choosing REMI and its advanced, modern technology gives you and your patients the information you need

REMI SYSTEM SAFETY INFORMATION

INDICATIONS
REMI Remote EEG Monitoring System Indications for Use

The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI uses single use, single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days.

The REMI System uses the REMI Mobile software application that runs on qualified commercial off-the-shelf mobile computing platforms. REMI Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it is stored and prepared for review on qualified EEG viewing software.

REMI does not make any diagnostic conclusion about the subject’s condition and is intended as a physiological signal monitor. The REMI System is indicated for use with adult and pediatric patients (6+ years).

Please click here for full Instructions for Use.

REMI Vigilenz AI For Event Detection Indications for Use 

REMI Vigilenz AI For Event Detection is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings. REMI Vigilenz AI For Event Detection is intended to be used by physicians qualified to analyze and interpret EEG who will exercise professional judgment in using the information. 

As an aide to the qualified physician’s REMI EEG review, REMI Vigilenz AI For Event Detection marks previously acquired sections of REMI EEG that may correspond to neurological events of interest indicative of potential electrographic seizures lasting at least 10 seconds in duration. REMI Vigilenz AI For Event Detection is indicated for use with adult and pediatric patients (6+ years). 

REMI Vigilenz AI For Event Detection does not mark REMI EEG records in real time and does not provide any diagnostic conclusion about the patient’s condition to the user.

Please click here for full Instructions for Use.

References: 1. Frankel MA, Lehmkuhle MJ, Spitz MC, Newman BJ, Richards SV, Arain AM. Wearable reduced-channel EEG system for remote seizure monitoring. Front Neurol. 2021;12:728484. doi:10.3389/fneur.2021.728484 2. Davey Z, Gupta PB, Li DR, Nayak RU, Govindarajan P. Rapid response EEG: current state and future directions. Curr Neurol Neurosci Rep. 2022;22(12):839-846. doi:10.1007/s11910-022-01243-1 3. REMI™ Remote EEG Monitoring System. Instructions for use. Epitel, Inc.; January 2024. 4. REMI Vigilenz™ AI For Event Detection. Instructions for use. Epitel, Inc.; January 2024.

ISI
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465 S. 400 E
Suite 250
Salt Lake City, UT 84111
801-497-6297
info@epitel.com

Instructions for Use for REMI™ and REMI Vigilenz™ AI

For technical and customer support, please call: 

© 2024 BY EPITEL

All rights reserved. Epitel, REMI, and REMI Vigilenz AI are trademarks of Epitel, Inc.
All other trademarks are the property of their respective owners. 

801-497-6297

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