Patient Manual for Ambulatory Use

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 1 of 40

Table of Contents
Safety Information

4

Acronyms, Abbreviations, and Definitions

4

Indications for Use

5

Contraindications

5

Operator Profile

5

Explanation of Signal Word Consequences

6

Warnings

6

Precautions

6

Adverse Reactions

8

Section 1 - Getting Started with REMI
Overview of REMI System

99Information on REMI Sensors

9Information on REMI Phone

10

Going Home with REMI
Section 2 - Navigating REMI Mobile on Your REMI Phone

1213

Sleep Screen

13

Navigating the Home Screen

14

Best Practices for REMI Phone

15

Setting Up a New Wi-Fi

15

Section 3 - Sticker Changes & Sensor Placement

18

Steps to Complete a Sticker Change

18

Logging a Sticker Change for Clinician Review

20

Using the Sensor Application Guide

21

Sensor Orientation and Placement

22

Section 4 - Logging Suspected Events for Clinician Review

23

Section 5 - End of Session Activities

24

Return REMI Device to Your Healthcare Provider
Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 2 of 40

25

Section 6 - Troubleshooting
Frequently Asked Questions

26
26

REMI Sensors

26

REMI Phone

27

REMI Phone Error Notifications

30

Low Battery

31

Connection Not Available

31

Compliance and Certification Appendices32

Appendix A - EMC Compliance32

Appendix B - FCC Intentional Radiator Certification

32

FCC Part 15 Information to the User

32

Appendix C – FCC Radiation Exposure Statement

33

Appendix D - Technical and Security Information

33

Wireless Communication

33

Cybersecurity

34

Appendix E – REMI Sensor Specifications and LED Indications

35

Appendix F - Additional REMI Device Information

36

REMI Phone Description

36

REMI Sensor Description

36

Additional REMI Device Descriptions

36

Appendix G - Symbols Glossary

37

Legal and Regulatory Information

40

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 3 of 40

Safety Information
Please read, understand, and follow all safety information contained in these instructions
prior to using REMI™ Remote EEG Monitoring System. Retain these instructions for futurereference.

Acronyms, Abbreviations, and Definitions
EEG

Electroencephalography

REMI Sensor / sensor

Disposable EEG sensor

REMI Sticker / sticker

Conductive-adhesive sticker used with REMI Sensors

REMI / REMI System

Remote EEG Monitoring System

REMI Mobile App / REMI
MobileThe mobile medical application that runs on qualified mobile
computing platforms.

REMI Tablet / tablet

A tablet mobile computing platform running REMI Mobile
Software to initialize a session

REMI Phone / phone

A phone mobile computing platform running REMI Mobile
Session in the ambulatory environment

REMI Cloud

Cloud-based servers and storage where REMI EEG is processedand stored

Bluetooth® / BLE

Secure, single-device Bluetooth Low Energy protocol, used for
wireless communication between REMI Sensors and REMI
Mobile software

Operating System / OS

Native software that allows smart devices to run applications
and programs

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 4 of 40

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 electricalactivity 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 fromconnected REMI Sensors to the secure REMI Cloud where it is stored and prepared forreview on qualified EEG viewing software.
REMI does not make any diagnostic conclusion about the subject's condition and isintended as a physiological signal monitor. REMI System is indicated for use with adultand pediatric patients (6+ years).

Contraindications● REMI System should not be used on any patients who knowingly have ahypersensitivity to acrylics, silicones, and hydrogels.
● REMI Sensors should not be placed on a patient’s scalp if there are open wounds atthe sensor target locations.
● REMI System should not be used on any children under the age of 6 years.

Operator Profile
REMI System can be used by trained medical professionals who wish to record
electroencephalograms as described in the Indications for Use section above.
Patients and/or Caregivers are intended to use the ambulatory components of REMI
System as described by this manual. For additional information on the broader REMI
System, refer to the Clinician Manual for Ambulatory Use available through a qualified
healthcare provider.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 5 of 40

Explanation of Signal Word Consequences
Signal WordWARNING
PRECAUTION /CAUTION
IMPORTANT

Consequence
Indicates a hazardous situation, which, if not avoided, could resultin major injury and/or death.
Indicates a hazardous situation, which, if not avoided, could resultin minor injury and/or property damage.
Indicates a special item of note that the user must be aware of forthe system to work properly.

Warnings● To reduce the risk of bodily injury,o Do not ingest REMI Sensors or stickers.
o Only use power adapters for REMI Phone operating platform as provided byEpitel, and only connect the power adapters to properly tested and grounded
AC outlets. Do not connect the power adapters to an AC outlet controlled by awall switch.
● To reduce the risks associated with cleaning, follow all cleaning instructions includedin this manual. Establish and follow a cleaning schedule.
● Do not apply REMI Sticker to any surfaces other than the sensor or patient's scalp
prior to use in order to maintain proper adhesive performance.
● REMI System is considered magnetic resonance (MR) unsafe. Remove all REMI
Sensors before performing a magnetic resonance imaging (MRI) scan. Do not bring
any REMI System components into a MR environment.

Precautions● Caution: Federal law (USA) restricts this device to sale by or on the order of aphysician.
● Avoid using REMI Sensors near strong radio frequency signals or portable and/or
mobile RF devices to reduce the risks associated with very strong electromagnetic
fields.
● To avoid artifacts in a computed tomography (CT) image of the skull, remove REMI
Sensors prior to execution of the CT procedure.
● Advanced Settings on REMI Phone should only be accessed with the assistance of
trained Epitel staff. Changes in device provisioning settings can result in delays in theinitialization of a new session. To access, contact Epitel for the Provisioning
Passcode.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 6 of 40

● To reduce the risk of damaging REMI Sensors,o Do not immerse the sensors in a liquid or subject them to any sterilization
processes.
o Do not impact, puncture, or cut them with any objects.
o Follow the sensor sticker replacement process as instructed in this manual andin the Clinician Manual for Ambulatory Use.
● REMI Sensors can only be used by one patient, for one session. At the end of yourrecording, the sensors will no longer be able to record EEG.
● REMI Stickers can only be worn once. The stickers will lose their stickiness after they
have been removed from your scalp. You should dispose of the used stickers every
time you remove the sensor like you would a bandaid or other skin adhesive.
● Check your skin around sensor placement sites daily. If you experience any adverse
reactions (e.g., redness, itching, or swelling), remove your sensors and contact yourclinic.
● When using a fresh REMI Sticker:
o Make sure that the blue liner side is applied to the sensor. The clear liner side ismeant to contact your skin.
o Be sure to align each of the sticker's circles with the sensor's gold electrodes.
o Try to avoid getting any of your hair between the sensor and your scalp when
you reapply your sensors. Hair will reduce stickiness and may cause issues withyour REMI EEG recording.
● Always try to keep your phone within 13 feet (or 4 meters) of your sensors. If yourphone is too far away, it will struggle to communicate with your sensors. It is
recommended to keep the phone in your pocket, near your bed, or otherwise nearby
at all times to avoid any delays in sending data to your clinician.
● Do not let the phone battery die. Charge your phone intermittently while you areawake and keep it charging near your bed while you sleep. Only use the power
adapters that are provided by your clinician. Other phone charging cables may not becompatible with REMI Phone.
● EEG data will not be transmitted by the computing platform or available for clinician
review during the time that:o A disconnection occurs between REMI Mobile and REMI Cloud.
o A disconnection occurs between REMI Sensors and REMI Mobile.
● The radio frequency field strength generated by REMI Sensors is at a levelconsidered safe to use with other medical devices. However, if another device
experiences electromagnetic interference when REMI Sensors are nearby, consider
moving the sensors away from that device.
● REMI System, including REMI Sensors and stickers are not packaged sterile.
● REMI Sensors and REMI Phone computing systems contain batteries and should be
stored in appropriate environments as described herein.
● No modification is allowed of any equipment described herein. Only authorized Epitel
personnel are permitted to repair any component of REMI System.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 7 of 40

● REMI Sensor gold electrodes should not come into contact with any conductive parts
other than REMI Sticker.
● The use of a defibrillator while wearing REMI Sensors may affect EEG recordings and
REMI Sensor functionality.
● REMI Mobile system updates require that REMI Tablet / REMI Phone be powered on
and connected. For the fastest and most reliable updates, it is recommended toconnect REMI Phone computing system to Wi-Fi for system updates.
● The "Add Event" button does NOT notify your doctor or emergency services. For
emergencies, contact your local emergency services or dial 911.

Adverse Reactions
While unlikely, a patient may have an adverse allergic reaction to REMI Sticker (e.g. they
have unknown hypersensitivity to acrylics or hydrogels). Immediately discontinue use if
any redness, excessive itching, or swelling occurs.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 8 of 40

Section 1 - Getting Started with REMI
Overview of REMI System
To get started with REMI Ambulatory, your clinician uses a REMI Tablet to start your EEG
session and place your sensors. Once your sensors are securely in place, your clinician
will connect your sensors to a REMI Phone. If you have any questions about the session
initiation process, please refer to the Clinician Manual for Ambulatory Use available
through your healthcare provider.

The REMI Tablet is only used for session initiation. Once set-up, you will go home withyour REMI Phone and sticker kits for your daily sticker changes.

Information on REMI Sensors
After initial placement, the REMI Sensors will begin recording. The sensors work by
amplifying and digitizing the EEG from the patient’s scalp. REMI Sensors are held in placeusing special REMI Stickers that stick to your skin. The stickers are not intended to bereused. You should replace your stickers every time you remove a sensor and dispose of
the used sticker, just like you would a bandaid or other skin adhesive.
CAUTION: To reduce the risk of damaging REMI Sensors, do not immerse the sensors ina liquid or subject them to any sterilization processes.
CAUTION: To reduce the risk of damaging REMI Sensors, do not impact, puncture, or cut
them with any objects.
CAUTION: REMI Sensors can only be used by one patient, for one session. At the end ofyour recording, the sensors will no longer be able to record EEG.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 9 of 40

Information on REMI Phone
The REMI Phone is critical for a successful REMI Session. It runs the REMI Mobile App,wirelessly receiving information from your sensors and sending it to your clinician using
either cellular or Wi-Fi.
CAUTION: Always try to keep your phone within 13 feet (or 4 meters) of your sensors. If
your phone is too far away, it will struggle to communicate with your sensors. It is
recommended to keep the phone in your pocket, near your bed, or otherwise nearby at all
times to avoid any delays in sending data to your clinician.
CAUTION: Do not let the phone battery die. Charge your phone intermittently while you
are awake and keep it charging near your bed while you sleep. Only use the power
adapters that are provided by your clinician. Other phone charging cables may not becompatible with REMI Phone.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 10 of 40

REMI Phone Home Screen - In Session
You can interact with the REMI Mobile App using your REMI Phone touch screen. The app
allows you to log different activities throughout your session. For additional information on
logging events and activities, please refer to Section 3 - Sticker Changes & Sensor
Placement and Section 4 - Logging Suspected Events for Clinician Review.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 11 of 40

Going Home with REMI
REMI Sessions can run for multiple days. Your clinician will set the duration of therecording during the initial setup. You should plan to wear the sensors as much as
possible throughout your prescribed duration. This includes wearing your sensors
throughout the day and while sleeping.
Along with your REMI Sensors and your assigned REMI Phone, your clinician will send you
home with the following materials:●
An adequate number of Daily Sticker Kits, which include four (4) new REMI
Stickers and four (4) alcohol wipes, to allow you to change and replace REMI
Stickers throughout your REMI EEG recording session●
One (1) REMI Phone charger and charging cableAn unopened Daily Sticker Kit (right) with its contents: REMI Stickers (upper left),
Alcohol Wipes (lower left)Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 12 of 40

Section 2 - Navigating REMI Mobile on Your REMI Phone
The REMI Mobile App has two (2) default screens: sleep screen and home screen. During
your session, you are able to interact with both by using your phone’s touch screen. If you
need to restart your phone at any time, press and hold the green button on the right sideof the device.

Sleep Screen
The sleep screen is intended to limit battery drain during your REMI EEG recording
session. This screen will automatically appear after several minutes of inactivity OR if you
select the “moon” Sleep Mode icon on the home screen. To unlock and access the home
screen, swipe up from the bottom of the screen using a finger.

Power button
To power on or restartthe device hold for up
to 30 seconds

Sleep Screen (with navigation notes)

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 13 of 40

Navigating the Home Screen
The home screen is the primary screen for interacting with the REMI Mobile App. From
this screen, you can find a countdown to the end of your REMI EEG recording session,view current battery power levels, check connectivity to cellular or Wi-Fi, save a suspected
event, complete a sticker change, and access general settings.
OS Bar with current time, cellularconnectivity, Wi-Fi connection (if enabled),
current battery level
General Settings
Sleep Mode

Countdown to endof session
Save a suspected event

Complete a
sticker change

Keep phone poweredon and charged up

Support forcompleting a sticker
changeHome Screen (with navigation notes)

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 14 of 40

Best Practices for REMI Phone
Follow these three tips to ensure your REMI Phone is functioning optimally.
1.
2.
3.

Keep your REMI Phone within 3 ft of the sensors at all times; including keeping it
near your bedside while you sleep
Avoid letting the battery die during or after the active recording
Connect to strong Wi-Fi whenever possible

Setting Up a New Wi-Fi
Connecting to Wi-Fi allows for the most consistent and reliable connection on your REMI
Phone. Setting up a new Wi-Fi connection on your REMI Phone is similar to setting up
other smart devices. First, navigate to the General Settings menu by selecting the gear
icon on the Home Screen. From the General Settings, you can also view information forcustomer support contact, general device and session details, and manufacturing
information.
After you open the Wi-Fi Settings menu, you will see a list of available Wi-Fi connections.
Select your preferred connection. If the Wi-Fi connection is protected, you will need toenter the appropriate password to connect.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 15 of 40

Exit General Settings Menu
Access Wi-Fi Settings Menu

General Settings Menu (with navigation notes)

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 16 of 40

Use Wi-Fi toggled ON

Select your preferred Wi-Fi
from the available list

FOR REPRESENTATION ONLY
Wi-Fi Settings Menu (with navigation notes)
IMPORTANT: If a public network (i.e. airports, malls, and libraries) requires anything in
addition to a passcode (such as acceptance of terms and conditions), then your REMI
Phone will be unable to complete the connection.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 17 of 40

Section 3 - Sticker Changes & Sensor Placement
Steps to Complete a Sticker Change
Whether you are replacing all four stickers or want to reposition a single sensor, you
should follow the same process to remove, replace, and reapply your sensors. You willneed to grab one of your daily sticker kits. Reminder, daily sticker kits include four (4) new
REMI Stickers and four (4) alcohol wipes.
CAUTION: Check your skin around sensor placement sites daily. If you experience any
adverse reactions (e.g., redness, itching, or swelling), remove your sensors and contact
your clinic.
1.

2.
3.

4.
5.
6.
7.

Remove the sensor(s) from your scalp and keep track of where your sensors
were previously placed. It is important that the sensors are placed in the same
location that your clinician originally applied them.
Remove and dispose of all used sticker(s).
Open a new sticker pouch when you are ready to apply a new sticker to thesensor. Remove the BLUE liner from the sticker, then apply the exposed sticker
to the sensor. Be sure to align the circles with the gold electrodes.
Use the provided alcohol wipes to clean your scalp. Make sure your skin is fully
dried before reapplying the sensor.
When ready, remove the clear plastic liner from the sticker.
Place the sensor back in its original location. Use the “Sensor Application
Guide” to ensure the sensors are properly placed.
Finally, after reapplying the sensor to your skin, press the top of the sensor
three (3) times. You should be able to feel a button click with each press.

Remove the Blueliner to apply tosensorAlign the circles
with the gold
electrodes

Remove theclear liner toapply to scalp

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 18 of 40

CAUTION: REMI Stickers can only be worn once. The stickers will lose their stickinessafter they have been removed from your scalp. You should dispose of the used stickers
every time you remove the sensor like you would a bandaid or other skin adhesive.
CAUTION: REMI Sensors can only be used by one patient, for one session. At the end ofyour recording, the sensors will no longer be able to record EEG.
IMPORTANT: Sticker changes can cause “noise” in your EEG data. Therefore, every
sticker change should be logged on the REMI Phone so that your healthcare provider,
upon reviewing your REMI EEG record, can see times when a sticker change has
occurred. Refer to the Logging a Sticker Change for Clinician Review within this manual
for additional information.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 19 of 40

Logging a Sticker Change for Clinician Review
REMI Phone has the ability to log sticker changes. This feature allows you to create notesin the EEG record that inform your healthcare provider when and why you changed yourstickers. Select the “Sticker Change” button on the Home Screen to begin.
The feature will default the Removal Time with the current time, but you have the ability toadjust this if needed using the dropdowns. You may also Select Reason for Sticker
Change. When you click “Save”, you will receive a confirmation that the activity was
saved. If you wish to exit without saving the event, select “Cancel” to return to the Home
Screen.

Sticker Change Screen (with navigation notes)

Dropdowns available to adjust
the Removal Time as needed

Select a reason for the sticker
change; you may only selectone

Logs activity to the session
record for clinician review

Returns to Home Screen without
savingPatient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 20 of 40

Using the Sensor Application Guide
If you would like a visual to help with placing the sensors back on your scalp, you can finddetailed information using the REMI Mobile App’s “Sensor Application Guide”, accessible
at any time through the Home Screen. This guide contains details for each location,
including guiding visuals to confirm orientation and location.

Exit Sensor Application Guide

Swipe left/right to view other locations

Sensor ID label can be found on thebottom of each sensor

FOR REPRESENTATION ONLY

Left Ear Location - Sensor Application Guide (with navigation notes)
IMPORTANT: After reapplying the sensor to your skin, press the top of the sensor three(3) times. You should be able to feel a button click with each press.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 21 of 40

Sensor Orientation and Placement

Left Side
Rotate the gold dots
to point upwards

Left Side Locations - Excerpts from Sensor Application Guide

Right Side
Rotate the gold dots
to point downwards

Right Side Locations - Excerpts from Sensor Application Guide
CAUTION: Try to avoid getting any of your hair between the sensor and your scalp when
you reapply your sensors. Hair will reduce stickiness and may cause issues with your
REMI EEG recording.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 22 of 40

Section 4 - Logging Suspected Events for Clinician Review
Similar to a written seizure diary, the REMI Mobile App has the ability to log suspected
events throughout the duration of your recording. This feature allows you or your caregiverto create notes in the EEG record that your healthcare provider can review.
Select the “Add Event” button on the Home Screen. The feature will automatically fill theStart Time with the Current Time, but you can adjust using the dropdowns. You can also
add additional information on the Duration of the suspected event. When you select“Save”, you will receive a confirmation that the event was saved. The suspected event will
be logged as a note in the REMI EEG record that your clinician can view. If you wish to exit
without saving the event, select “Cancel” to return to the Home Screen.

The "Add Event" button does NOT
notify your doctor or emergency
services. For emergencies, contact yourlocal emergency services or dial 911.

Dropdowns available to adjust theStart Time as needed
Optional dropdowns available toadjust the Duration if desired

Logs event within the session
record for clinician review
Returns to Home Screen without
savingAdd Event Screen (with navigation notes)

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 23 of 40

Section 5 - End of Session Activities
Once you have reached the end of your prescribed REMI EEG recording duration, your
REMI Phone will automatically begin its end of session activities. This final step isimportant in finalizing your data for clinician review.
Remove all of your sensors and be sure to discard the used stickers. Place the sensors onor near your REMI Phone and press each sensor button three times. REMI Mobile will
retrieve final information from your sensors to create a complete REMI EEG record. Thiscan sometimes take up to a few days. Be sure to leave the sensors there until REMI
Mobile displays an “All done!” screen.
Keep phone poweredon and charged up

Progress indicator
This can take anywhere from a
few minutes to a few days

One last step! Screen (with navigation notes)

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 24 of 40

Return REMI Device to Your Healthcare Provider
Once the End of Session activities are complete, power off your REMI Phone and return
your sensors, phone, and charging cable to your healthcare provider.

Press and hold topower off

For clinician use

All done! Screen (with navigation notes)

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 25 of 40

Section 6 - Troubleshooting
The REMI Mobile App provides system notices to support session troubleshooting. In
case of medical or healthcare questions, always contact your healthcare provider. For
technical assistance, call Epitel at:
Phone: (801) 497-6297
Email: support@epitel.com

Frequently Asked Questions
REMI Sensors
For technical specifications or more detailed information on your REMI Sensors, pleaserefer to Clinician Manual for Ambulatory Use, available through your qualified healthcare
provider.
I lost a sensor, what now?
If you lose or damage one of your REMI Sensors, the remaining sensors will continue torecord your EEG. Be sure to let your healthcare provider know that you’ve lost a sensor;
they will provide you with next steps.
What if I need to remove my sensors for an extended period of time?
If you need to remove your sensors for longer than an hour, the Sticker Change screen
can be completed and saved at the time of removal. The sensors can be applied after theextended time with no further interaction with the phone. You should inform yourhealthcare provider if you have removed your sensors for an extended period of time.
What do the different LED colors mean on REMI Sensor?
When you press the top of the sensor, you may notice an LED light. The LED should
remain dark unless you intentionally press the sensor.
After pressing the top of the sensor, you may see one of the following:● Single green flash - the sensor is active and recording; this is the most common
LED pattern you will see.
● Continuous red flashes, up to ten (10) times - the sensor will not record EEG;
inform your healthcare provider if you notice that your sensor is blinking red after abutton press.
● Spontaneous blue and red flashes - the sensor is active and broadcasting; the LED
will return to its normal dark state without any additional action from you; informyour healthcare provider if you notice this for over an hour.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 26 of 40

How do I clean my REMI Sensors?
REMI Sensors should only be cleaned with a damp cloth using water and should never be
immersed in any liquids. REMI Sensors can be cleaned as often as you perform a sticker
change.
I can’t remember my original sensor location! What should I do?
If you forget your sensor locations, you can use the Sensor Application Guide, accessible
through the REMI Mobile App’s Home Screen, for guidance. Each screen within the guideprovides the sensor ID of the appropriate REMI Sensor for that location. You can confirm
the sensor IDs by removing the sticker on the bottom of the sensors and examining the 3digit alphanumeric label. Refer to the Using the Sensor Application Guide in this manual
for additional information.

REMI Phone
For technical specifications or more detailed information on your REMI Phone, please refer
to Clinician Manual for Ambulatory Use, available through your healthcare provider.
How do I clean my REMI Phone?
You can clean your REMI Phone by using a cloth dampened with diluted cleaning agent
like bleach or alcohol. Do not immerse the device in any liquids.
My phone is not responding when I interact with it, is something wrong?
When your phone is unresponsive, it may be necessary to force a hard reboot. You can dothis by pressing and holding the green power button on the side of the device andselecting “Restart”. It will take a few seconds to reboot. The phone should return to thescreen you were previously interacting with.
Why won’t REMI Phone charge with my personal phone charger?
You should only charge your phone using the labeled charger and charging cableprovided by Epitel. Although you may have your own phone charger, the REMI Phone is
not compatible with fast charging cables typically provided with personal smart devices. If
you use other chargers or cables, the phone may not charge properly.
What do I do if REMI Phone does not start?
Before trying to power up your phone, always make sure your Phone is plugged into its
charger. The battery can drain and the device can shut down as a result. You will need torecharge the phone for up to thirty minutes before powering up. You can start the device
by pressing and holding the green power button for 30 seconds.
My phone is damaged, what do I do?
All repairs, updates, and returns are managed through your healthcare provider. If yourphone becomes damaged or lost, please contact your provider for next steps.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 27 of 40

I tried to add my Wi-Fi, but I don't see a list of available Wi-Fi networks.
If you do not see a list of available connections, double check that the “Use Wi-Fi” toggle
is switched ON. After toggling the switch ON, give the device a few minutes to find nearby
available connections.

Wi-Fi Settings Menu - Toggle “Use Wi-Fi”

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 28 of 40

My phone died! Is my session ruined?
If left off the charger for too long, the phone battery may drain and die. That’s okay! At
your earliest convenience, put the phone on the charger. Once the battery is no longer
critically low, you can restart the REMI Mobile App by pressing and holding the green
power button for 30 seconds. This will return you to your REMI EEG recording session.
Your session will re-establish connection once rebooted and will continue through its
remaining prescribed duration. Please note, if the phone battery dies for an extended
period of time this may cause a slight delay in completion of the end of session activities.
What is the QR Code for?
At the end of your session, if you select “Start
New Session” you will be taken to the “Ready foruse screen”. This screen is for clinician use only.
Power down the phone and return it to yourhealthcare provider at your earliest convenience.
Can I call for assistance using my REMI
Phone?
Your REMI Phone does not support generalphone functionality. In case of emergencies, you
should always use other means to call forassistance. Additionally, the “Add Event”
functionality is not an alerting feature and will
not contact any medical support.

REMI Phone System Ready Screen

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 29 of 40

REMI Phone Error Notifications
The REMI Mobile App has a few error notifications that can occur and can impede theoverall session if left unresolved. You can readily resolve most errors.
Current power level &Connectivity status

Low power error notice

No connection available notice

REMI Mobile App List of Notifications (with navigation notes)

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 30 of 40

Low Battery
If your REMI Phone battery level is too low, you will receive the “Battery critically low”
notification. The only way to resolve this issue is to plug your device in using the provided
Charger and Charging Cable. The notification will go away with sufficient charge.

“Battery critically low” Notification
Connection Not Available
If your REMI Phone loses connection, you will receive the “Connection not available”
notification. You can lose connection if you do not have a strong enough cellularconnection or if you are not connected to a functional Wi-Fi. To resolve this issue, you
should connect to a reliable Wi-Fi source if possible. If you happen to be traveling briefly
out of cellular or Wi-Fi range, you can temporarily silence the notification by selecting the“X”.
This notification will resolve on its own when you return to reliable Wi-Fi and/or cellular
service.

Temporarily silences notification“Connection not available” Notification (with navigation notes)

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 31 of 40

Compliance and Certification Appendices
Appendix A - EMC Compliance
REMI Sensor complies with the EMC requirements of IEC 60601-1-2 and IEC 60601-1-11(see Appendices A & B) to ensure that it will operate in healthcare facilities and in thehome. To prevent RF interference with or from REMI System, portable and mobile RFcommunications equipment should be kept away from REMI components at distances
specified in Appendix B.

Appendix B - FCC Intentional Radiator Certification
REMI Sensor FCC ID: 2AVPHEPGD1
This equipment contains an intentional radiator approved by the FCC under the FCC ID
numbers shown above. This device complies with Part 15 of the FCC rules. Operation is
subject to the following two conditions: (1) This device may not cause harmfulinterference, and (2) this device must accept any interference received, includinginterference that may cause undesirable operation.
NO MODIFICATION: Modifications to the sensor shall not be made without the writtenconsent of Epitel, Inc. Unauthorized modifications may void the authority granted under
Federal Communications Commission rules permitting the operation of this device.

FCC Part 15 Information to the User
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. Thisequipment generates, uses and can radiate radio frequency energy and, if not set up andused in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in aparticular REMI session. If REMI System does cause harmful interference to other radio or
television reception, which can be determined by turning REMI System operating platform
off and on, the user is encouraged to try to correct the interference by one or more of thefollowing measures:●●●

Reorient or relocate the affected receiving antenna.

●

Consult Epitel support for help.

Increase the separation between REMI System and the affected receiver.
Connect REMI operating platform into an outlet on a circuit different from that towhich the affected receiver is connected.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 32 of 40

Appendix C – FCC Radiation Exposure Statement
This equipment complies with FCC radiation exposure limits set forth for an uncontrolledenvironment. This equipment is in direct contact with the body of the user under normal
operating conditions. This transmitter must not be co-located or operating in conjunction
with any other antenna or transmitter.

Appendix D - Technical and Security Information
Wireless Communication
REMI System uses Low Energy Radio Frequency (RF) operating at 2.45 GHz (maximum
1mW) for wireless communication between REMI Sensors and REMI Tablet.
● REMI Tablet should be kept within 4m (13 ft) of the patient during session
initialization.
● REMI Phone be kept within 4m (13 ft) of the patient while actively recording. It is
recommended to set up the charging station near patient sleeping arrangements.
REMI System uses Wi-Fi connection and/or a cellular connection for wirelesscommunication between REMI Mobile and REMI Cloud platform.
● All REMI Tablet wireless communication settings are configured by authorized
Epitel personnel and healthcare provider’s IT professionals during initial REMI
System setup and installation. These settings are password-protected, and theymust not be altered by anyone outside of the administrative users.
● REMI Phone communicates natively via cellular connection and can be configuredby the patient / caregiver to communicate via a Wi-Fi network.
REMI Mobile software will notify the user if there are any disconnection issues during theuse of REMI System. For additional information, Clinician Manual for Ambulatory Useavailable through a qualified healthcare provider.
REMI System complies with the IEEE C63.27-2017 American National Standard for
Evaluation of Wireless Coexistence standards. To prevent RF interference with or fromREMI System, portable and mobile RF communications equipment should be kept awayfrom REMI components at distances specified in the Clinician Manual for Ambulatory
Use.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 33 of 40

Cybersecurity
REMI Sensor communicates with REMI Mobile software through secure single-device BLE
protocols. There is no patient identifying information communicated between REMI Mobile
and REMI Sensors. Once a sensor is connected to a REMI operating platform running
REMI Mobile software, the sensor firmware and connection protocol cannot be changedor altered by the user. There are no specific user instructions for the sensor that pertain to
Cybersecurity controls.
REMI Mobile software communicates with REMI Cloud using an encrypted HTTPS
protocol via a Wi-Fi network and/or a cellular network.
REMI Cloud runs on the Amazon Web Services™ (AWS) cloud platform and follows AWS
best practices for HIPAA security and compliance, including end-point protections andlimited/secured user access. Access to patient data via Persyst Mobile running on REMI
Cloud platform is password protected. Reviewing physicians should not share theirpasswords with anyone. Should a reviewing physician’s password become compromised,please notify Epitel immediately for support.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 34 of 40

Appendix E – REMI Sensor Specifications and LED Indications
General Specifications
Physical Size:
Weight:Power Source:
Communication Interface:
User Interface:indication

27 mm L x 27 mm W x 5.8 mm H
5.0 g
Internal CR2025 3 V Lithium Coin Cell (not rechargeable)
Low Energy Wireless Radio Frequency (RF) – 2.45 GHz(maximum 1mW)
Single key membrane keypad for activation and status

Recording Specifications
Number of Signal Channels:
Sample Rate:
Recording Range:
Amplifier Passband:

1
256 Hz± 500 µV, 12-bit
0.8 Hz – 92 Hz

Electrode Specifications
Number of Electrodes:
Electrode Size:
Electrode Spacing:Electrode Type:

2 (Signal and Reference)
6.0 mm diameter circular
17.7 mm center-center
Hard gold electrode

LED Status Indication – Button Press
No LED or 2 x Red
sensor error (if persistent, sensor cannot be used)
3 x Blue then 2 x Greensensor activated and waiting for connection
1 x Green
sensor working correctly
5 x Redsensor retired (no wireless connection allowed)

Compliance Standards
Degree of Protection
Ingress Protection

Operation Environment
Typical Operation Time /Expected Service Life

IEC-60601-1, IEC-60601-2-26, IEC-60601-1-2,
IEC-60601-1-11, IEC 62133-2, IEEE C63.27, ISO
10993, ISTA-6-FEDEX-A, IEC 62366, IEC 62304
Type BF Applied Part (REMI Sensor)
IP47 – Protected against solid foreign objects of
1.0 millimeters and greater. Protected against theeffects of temporary immersion in water.
REMI Sensors have been tested for operation
environments of 37°F to 100°F (3°C to 38°C),
relative humidity above 10% (non-condensing),
525 to 795 mmHg (700 to 1060 hPa).
REMI Sensors are capable of collecting andtransmitting data for a minimum of 48 hours.

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 35 of 40

Appendix F - Additional REMI Device Information
REMI Phone Description
REMI Phone is used for ongoing recording and processing of a REMI session. The userinterface for REMI Phone operating platform is a touchscreen display powered by an A/C
adapter and onboard rechargeable battery. With proper cleaning and maintenance, REMI
Phone should be reused for multiple sessions. Each REMI Phone has a unique serial
number located on their back cover and within the application under the Settings Menu.
REMI Phone software version can also be found in the application’s Settings Menu.
Additionally, Legal & Copyright information for REMI Phone software is accessible throughthe Advanced Settings screen.

REMI Sensor Description
The user interface for REMI Sensors is a single button within each sensor. The power isthrough a single-use primary coin cell battery for each sensor. Using its wireless link, thesensors can exchange EEG data and commands with REMI Mobile application running on
REMI Tablet or REMI Phone. Each REMI Sensor has a unique serial number located on thesensor packaging.
REMI Sensors attach to the patient’s scalp via a conductive-adhesive sticker. This sticker
is made of a medical adhesive with conductive hydrogel disks and has been tested forbiological safety. Each sticker has a unique lot number located on the sticker packaging.
REMI Sensors and stickers should be disposed of after each use.

Additional REMI Device Descriptions
Please refer to Clinician Manual for Ambulatory Use available through a qualified
healthcare provider for additional information on the following items:● Device descriptions of REMI Tablet, REMI Cloud, or REMI System Device
Communications● Warranty policy● Electromagnetic Emissions Declarations● Electromagnetic Immunity Declarations

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 36 of 40

Appendix G - Symbols Glossary
Note: The symbols provided below are applicable to medical use of REMI
System, including REMI Mobile software application. REMI Mobile application
operates on a qualified mobile computing platform (e.g., tablet, phone) which
may support other uses and bear additional unlisted symbols.
SymbolSymbol Title

Explanatory Text

Standard
Reference

Type BF
applied part

The equipment provides protection
against electrical shock and electricalcurrent leakage. Applied parts are
considered to be REMI Sensors withadhered stickers.

IEC 60417
Reference no.
5333

CatalognumberISO 15223-1:
Indicates the manufacturer's catalog
2021
number so that the medical device can be Reference no.
identified.
5.1.6. (ISO
7000-2493)

Batch code

Indicates the manufacturer's batch code
so that the batch or lot can be identified.
Synonyms for “batch code” are “lotnumber”, “lot code” and “batch number”.

ISO 15223-1:
2021
Reference no.
5.1.5. (ISO
7000-2492)

Indicates the date after which the medical
device is not to be used.

ISO 15223-1:
2021
Reference no.
5.1.4. (ISO
7000-2607)

Indicates the need for the user to consult
the instructions for use.

ISO 152231:2021
Reference no.
5.4.3. (ISO
7000-1641)

Indicates the temperature limits to which
the medical device can be safely exposed

ISO 15223-1:
2021
Reference no.
5.3.7. (ISO
7000-0632)

Use-by date

Consult
instructions foruse

Temperature
limit

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 37 of 40

SymbolSymbol Title

Explanatory Text

Humidity
limitation

Indicates the range of humidity to which
the medical device can be safely
exposed.

Standard
Reference
ISO 15223-1:
2021
Reference no.
5.3.8. (ISO
7000-2620)

CFR Title 47
FederalIndicates the device has been tested to
Chapter I
Communicatio comply with FCC standards and has been
Subchapter A
ns Commission approved
Part 15
FCC ID

IP47

FederalA unique identifier assigned to a device
Communicatio
registered with the United States Federal
ns Commission
Communications Commission
Identification

CFR Title 47
Chapter I
Subchapter A
Part 15

Do not re-use

Indicates a medical device that is
intended for one single use only
NOTE: Synonyms for “Do not reuse” are“single use” and “use only once”.

ISO/DIS
152231:2021
Reference no.
5.7.7

Ingress
protection

Protected against solid foreign objects of
1.0 millimeters and greater.
Protected against the effects of
temporary immersion in water.

IEC 60529

MR unsafe

An item which poses unacceptable risks
to the patient, medical staff or otherpersons within the MR environment.

ASTM F2503
Reference no.
Table 2,
Symbol 7.3.3;
7.4.9.1; Fig. 9

CautionTo indicate that caution is necessary
when operating the device or control
close to where the symbol is placed, or toindicate that the current situation needs
operator awareness or operator action inorder to avoid undesirable consequences.

ISO 15223-1:
2021
Reference no.
5.4.4. (ISO
7000-0434A)

Serial Number

Indicates the manufacturer's serial
number so that a specific medical device
can be identified.

ISO 15223-1:
2021
Reference no.
5.1.7. (ISO
7000-2498)

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 38 of 40

SymbolSymbol Title

Explanatory Text

Standard
Reference

sensoridentification
numberIndicates the identification number of thesensor.

N/A

Non-sterile

Indicates a medical device that has notbeen subjected to a sterilization process.

ISO 15223-1:
2021
Reference no.
5.2.7. (ISO
7000-2609)

Indicates the item is a medical device.

ISO/DIS
152231:2021
Reference no.
5.7.7

Manufacturer

Indicates the medical device
manufacturer.

ISO 15223-1:
2021
Reference no.
5.1.1. (ISO
7000-3082)

Unique device
identifier

Indicates a carrier that contains uniquedevice identifier information.

ISO 15223-1:
2021
Reference no.
5.7.10Date ofmanufacture

Indicates the date when the medical
device was manufactured.

ISO 15223-1:
2021
Reference no.
5.1.3. (ISO
7000-2497)

Prescription
use only

Caution: Federal law (USA) restricts thisdevice to sale by or on the order of aphysician.

N/A

Medical device

Rx ONLY

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 39 of 40

Legal and Regulatory Information
This document was, as far as possible, accurate at the time of release, though subsequentchanges may have been made. Epitel reserves the right to alter specifications and details
as required. Late-breaking information may be supplied separately for completeness.
Product
REMI – Remote EEG Monitoring System
Manufacturer:
Epitel, Inc.
465 S. 400 E. Suite 250
Salt Lake City, UT 84111

Users should contact Epitel for assistance with setting up, using or maintaining equipment
if needed, or to report unexpected operations or events. For support contact Epitel at anyof the following:
Phone: (801) 497-6297
Email: support@epitel.com
Website: www.epitel.com

For Patent information, visit www.epitel.com/patents.
Copyright © Epitel, Inc. All rights reserved. Epitel, REMI, and REMI Vigilenz are trademarksof Epitel, Inc. All other trademarks are the property of their respective owners. No part ofthis document may be reproduced by any means without the prior written permission ofEpitel, Inc.
LB-0065 Rev 2 Rel: 08/2024

Patient Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 2
Page 40 of 40