User Manual for REMI Ambulatory Use

REMI Remote EEG Monitoring System

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User Manual for REMI Ambulatory Use

Symbols Glossary
SymbolSymbol Title

Type BF appliedpart

Explanatory Text
Standard Reference
The equipment provides
protection against electricalshock and electrical current
IEC 60417
leakage. Applied parts are
Reference no. 5333
considered to be the REMI
Sensors with adhered
Stickers.

Catalog number

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

Batch code

Indicates the
manufacturer's batch code
so that the batch or lot can ISO 15223-1: 2021
be identified. Synonyms for Reference no. 5.1.5.
“batch code” are “lot(ISO 7000-2492)
number”, “lot code” and“batch number”.

Use-by date

Indicates the date after
ISO 15223-1: 2021
which the medical device is Reference no. 5.1.4.
not to be used.
(ISO 7000-2607)

Consult
instructions foruse

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

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ISO 15223-1:2021
Reference no. 5.4.3.
(ISO 7000-1641)

Standard Title

Graphical
Symbols for Use
on Equipment

Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements
Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements
Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements
Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements

User Manual for REMI Ambulatory Use

SymbolSymbol Title

Explanatory Text

Standard Reference

Indicates the temperature
limits to which the medical
Temperature limit
device can be safely
exposedHumidity
limitation

FederalCommunications
Commission

FCC ID

FederalCommunications
Commission
IDentification

Do not re-use

IP47

Indicates the range ofhumidity to which the
medical device can besafely exposed.

MR unsafe

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

Indicates the device has
been tested to comply with
FCC standards and has
been approved
A unique identifier assigned
to a device registered with
the United States Federal
Communications
Commission
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”.

Protected against solid
foreign objects of 1.0
millimeters and greater.
Ingress protection
Protected against theeffects of temporary
immersion in water.
An item which poses
unacceptable risks to thepatient, medical staff orother persons within the
MR environment.

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

Standard Title
Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements
Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements

CFR Title 47
Chapter I
Subchapter A Part
15

Radio Frequency
Devices

CFR Title 47
Chapter I
Subchapter A
Part 15

Radio Frequency
Devices

ISO/DIS 152231:2021
Reference no. 5.7.7

Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements

IEC 60529

Degrees ofprotection
provided byenclosures (IP
Code)

ASTM F2503
Reference no. Table
2, Symbol 7.3.3;
7.4.9.1; Fig. 9Standard Practicefor Marking
Medical Devices
and other Items
for safety in the
Magnetic
Resonance
Environment

User Manual for REMI Ambulatory Use

SymbolSymbol Title

Standard ReferenceStandard Title

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

Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements

Serial Number

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

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

Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements

Sensoridentification
numberIndicates the identification
number of the Sensor.

N/A

N/A

CautionExplanatory Text
To indicate that caution isnecessary when operating
the device or control close
to where the symbol isplaced, or to indicate thatthe current situation needs
operator awareness oroperator action in order toavoid undesirable
consequences.

Non-sterile

Indicates a medical device ISO 15223-1: 2021
that has not been subjected Reference no. 5.2.7.
to a sterilization process.
(ISO 7000-2609)

Medical device

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)

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Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements
Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements
Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements

User Manual for REMI Ambulatory Use

SymbolSymbol Title

Explanatory Text

Standard Reference

Unique device
identifier

Indicates a carrier that
contains unique device
identifier information.

ISO15223-1: 2021
Reference no.
5.7.10Date ofmanufacture

Indicates the date when the ISO 15223-1: 2021
medical device wasReference no. 5.1.3.
manufactured.
(ISO 7000-2497)

Prescription use
Rx ONLY
only

Caution: Federal law (USA)restricts this device to sale
N/A
by or on the order of aphysician.

REMI Remote EEG Monitoring System

5Standard Title
Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements
Medical devices— Symbols to be
used withinformation to besupplied by the
manufacturer Part 1: General
requirements
N/A

User Manual for REMI Ambulatory Use

Table of Contents
Symbols Glossary
Table of Contents
Safety Information
Acronyms and Abbreviations
Device Description
Indications for Use
Contraindications
Explanation of Signal Word Consequences
Warnings
Precautions
Adverse Reactions
Operator Profile
Product Identifiers
REMI Tablet and REMI Smartwatch Operation
Session Initialization
Enter Patient Information and Prescribed Session Duration
REMI Sensor Preparation for Initial Placement
Retrieve Four REMI Sensors
Scan REMI Sensor Barcodes
Acquiring the Barcode
REMI Sensor Replacement
REMI Sensor Initialization
Sensor Placement
Applying a Sticker to REMI Sensor
Applying REMI Sensor to the Scalp
Locating the REMI Sensor in REMI Mobile
Restart Placement
Testing Sensor After Placement and Activation
Sensor Sync
Session Verification
Identify Sensor
Change Sensor Placement Location
Replace Sensor
Restart Session
REMI Smartwatch Handoff
Prepare REMI Smartwatch for Handoff
Completing the Handoff

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REMI Smartwatch Wi-Fi Setup
Logging a Seizure Event
Sensor Sticker Replacements
Initiate Sensor Sticker Change
Confirm Sticker Replacement
Place New Stickers on Sensors
Identify Sensor for Placement
Remove Second Liner and Place Sensor
Activate Sensor after Placement
End of Session Process
REMI Mobile Warning Alerts
Sensor Disconnect – During Sticker Change
Sensor Disconnect – Prior to Handoff
Multiple Sensors Activated on the REMI Tablet
REMI Mobile Connectivity Failure
REMI Cloud Server Error on the REMI Tablet
Poor Electrode Contact
Low Battery
Bluetooth Error on REMI Tablet
REMI Tablet Settings
Accessing Session Diagnostic Information for Customer Support
Persyst™ Mobile for EEG Review
Troubleshooting
EMC Compliance
FCC Intentional Radiator Certification
Wireless Communication
Cybersecurity
Server Maintenance
REMI Tablet and REMI Smartwatch Service and Repair
REMI Mobile Updates
Sensor Specifications
REMI Mobile Qualified Operating Systems
Product Cleaning
Product Returns
Appendix A – Electromagnetic Emissions Declarations
Appendix B – Electromagnetic Immunity Declarations
Appendix C – FCC Radiation Exposure Statement
Appendix D – REMI Sensor Specifications and LED Indications
Appendix E – Warranty

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

Acronyms and Abbreviations
EEG
REMI Sensor / Sensor
Sticker
REMI / REMI System
REMI Mobile
REMI Tablet
REMI Smartwatch
REMI Cloud
Persyst-Mobile

Electroencephalography
Single-channel disposable EEG sensor
Conductive-adhesive sticker used with REMI Sensors
Remote EEG Monitoring System
The mobile medical application that runs on qualified mobile
computing platforms.
A tablet mobile computing platform running REMI Mobile Software
A mobile computing platform running REMI Mobile session software
Cloud-integrated server processes necessary for the REMI System
Cloud-based EEG processing and reviewing software by Persyst

Device Description
REMI Sensors amplify and digitize the electroencephalogram (EEG) from a patient’s scalp. After
digitizing, the EEGs are sent to a qualified mobile operating platform running the REMI Mobile
software. REMI Mobile relays the EEG from four Sensors to the REMI Cloud running Persyst
software. The EEG data is accessible through Persyst Mobile where the four REMI Sensor(eight electrodes) EEG data is displayed as a montage of up to ten channels.
The user interface for the REMI Tablet operating platform is a 10” LCD touchscreen display.
REMI Tablet power is provided through an A/C adapter and onboard rechargeable battery.
The user interface for the REMI Smartwatch operating platform is a 2” LCD touchscreen display.
REMI Smartwatch power is through an A/C adapter and onboard rechargeable battery.
The user interface for REMI Sensors is a single button within each Sensor. Sensor power isthrough a single-use primary coin cell battery. Using its wireless link, the Sensors can exchange
EEG data and commands with the REMI Mobile application running on the REMI Tablet.
REMI Sensors attach to the patient’s scalp via a conductive-adhesive sticker. This Sticker ismade of a medical acrylic and foam adhesive with conductive hydrogel disks and has beentested for biological safety.

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 iswarranted. REMI uses single use, single patient, disposable, wearable sensors intended toamplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for aduration 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 andambulatory 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.

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REMI does not make any diagnostic conclusion about the subject's condition and is intended asa physiological signal monitor. The REMI System is indicated for use with adult and pediatricpatients (6+ years).

Contraindications●●●

The REMI System should not be used on any children under the age of 6 years.
The 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 at the
Sensor target locations.

Explanation of Signal Word Consequences
Signal WordWARNING
PRECAUTION /CAUTION
IMPORTANT

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

Warnings
●
●

●
●
●

To reduce the risk of bodily injury, do not ingest REMI Sensors or Stickers.
To reduce the risk of bodily injury, only use power adapters for the REMI Tablet / REMI
Smartwatch operating platform as provided by Epitel, and only connect the power adaptersto properly tested and grounded AC outlets. Do not connect the power adapters to an AC
outlet controlled by a wall switch.
To reduce the risks associated with cleaning, follow all cleaning instructions included inthis manual. Establish and follow a cleaning schedule.
Do not contaminate the Sticker. Sticker contamination can cause skin irritation andimproper attachment of Sensors to the scalp that may affect performance.
The 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 a physician.
Avoid using the Sensors near strong radio frequency signals or portable and/or mobile RFdevices 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.
To reduce the risks associated with an incorrect result, store and operate the REMI
Tablet / Smartwatch, Sensors and Stickers only as instructed in this manual.
To reduce the risk of damaging Sensors, do not immerse the Sensors in a liquid or
subject them to any sterilization processes.
To reduce the risk of damaging Sensors, do not impact, puncture, or cut them with any
objects.
To reduce the risk of damaging Sensors, follow the sensor sticker replacement process
as instructed in this manual.

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●
●
●
●
●
●
●
●

●
●
●

●

●
●
●
●
●
●
●

REMI Sensors and Stickers are single-patient, one-time use. Do not attempt to reuse
REMI Sensors or Stickers.
REMI Stickers should be replaced daily and REMI Sensors can only be used for a single
patient EEG recording session. Once a recording has ended all active Sensors will nolonger be able to connect to the computing platform or record EEG.
Ensure that the Sticker hydrogels are aligned over the gold electrodes. Failure to do so will
result in poor data quality.
Ensure that the blue liner side of the Sticker is applied to the Sensor. The clear liner sideof the Sticker is intended for patient contact.
Do not place the Sensor over hair. The REMI Sensor is meant to be used below thehairline. Placing the Sensor over hair may result in improper attachment to the scalp that
may affect performance.
In the case that a Sensor has fallen off of the scalp after a recording session has started,
the user should initiate a Single Sticker Change as described in the Single Sticker
Replacements section of this manual.
REMI Sensor wireless range is a maximum of 10m and it is recommendedƒ that the REMI
computing platform be kept within 4m of the patient to ensure a good wireless connection
between the Sensors and the computing platform.
REMI Sensors will record and store data from immediate placement until the end of theprescribed duration, but must be within 10m of the REMI Smartwatch to wirelessly transmit
the data. It is recommended that the patient stay within 4m of the REMI Smartwatch for atleast 8 hours a day. A suggested use is to set up the charging station near patient sleeping
arrangements.
EEG data will not be transmitted by the computing platform or available for clinician review
during the time that the computing platform is without power.
EEG data will not be transmitted by the computing platform or available for clinician review
during the time that disconnection occurs.
The REMI Smartwatch must be powered on and connected to cellular and/or internet inorder to send data via REMI Cloud to the Clinician viewing platform. It is recommended to
set up the charging station in an area of reliable connectivity. When able to successfullyreconnect to REMI Sensors, the REMI Smartwatch will initiate a data catch-up process atregular intervals, starting with the oldest missed recording data first.
The radio frequency field strength generated by REMI Sensors is at a level consideredsafe to use with other medical devices. However, if another device experiences
electromagnetic interference when REMI Sensors are nearby, consider moving the
REMI Sensors away from that device.
The REMI System, including REMI Sensors and Stickers are not packaged sterile.
The Sensors and REMI Tablet / Smartwatch computing system contain batteries andshould 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 the REMI System.
The REMI Sensor electrodes should not come into contact with any conductive parts otherthan the REMI Sticker.
The use of a defibrillator while wearing REMI Sensors may affect EEG recordings andSensor functionality.
If the REMI Tablet is mounted, ensure that it is securely mounted and that its size andweight do not exceed any limitations of the surface to which it is applied.
REMI Mobile system updates require that the computing platform be powered on andconnected. For the fastest and most reliable updates, it is recommended to connect the
REMI Tablet / Smartwatch computing system to Wi-Fi for system updates.

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DO NOT DISPOSE OF THE SENSORS. Ensure the Smartwatch stays connected andpowered on during the end-of-session screen.

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

Operator Profile
The 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 the REMI System
as described by this manual.
This manual provides complete information on how to operate REMI in both cases.

Product Identifiers
Each REMI Sensor has a unique serial number located on the Sensor packaging. Each Sticker
has a unique lot number located on the Sticker packaging. Each REMI Tablet and Smartwatch
have a unique serial number located on their back cover. The REMI Mobile software version
number can be found in the application About menu. The Smartwatch serial number andsoftware version number can be found in the About menu.

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REMI Tablet and REMI Smartwatch Operation
REMI Mobile software will initially be provisioned and configured on REMI Tablet / REMI
Smartwatch by healthcare facility personnel alongside Epitel staff. After initial provisioning, thecomputing platforms and REMI Mobile software are ready-to-use.
To operate the REMI Tablet, plug the tablet power supply in the DC-in jack and into a walloutlet. Press the power button until the Tablet turns on. The Tablet will take a few seconds toboot.
To prepare the REMI Smartwatch for operation, plug the REMI Smartwatch in the DC jack andinto a wall outlet. Once the REMI Smartwatch is fully charged, it is ready for use. Press thephysical green power button until the smartwatch turns on. The smartwatch will take a few
seconds to boot.
CAUTION: EEG data will not be transmitted by the computing platform or available for clinician
review during the time that the computing platform is without power.
CAUTION: EEG data will not be transmitted by the computing platform or available for clinician
review during the time that disconnection occurs.
CAUTION: REMI Mobile system updates require that the computing platform be powered on
and connected. For the fastest and most reliable updates, it is recommended to connect the
REMI Tablet / Smartwatch computing system to Wi-Fi for system updates.
IMPORTANT: For optimal performance, the REMI Tablet computing platform is recommended
to be plugged in at all times. The REMI Tablet will operate on battery power, however, once theTablet battery drops below 50% capacity an alert will pop up on the REMI Mobile application.
IMPORTANT: For optimal performance, the REMI Smartwatch is recommended to be plugged
in when possible. The REMI Smartwatch will also operate on battery power. Once theSmartwatch battery drops below 25% capacity an alert may pop up on the REMI Mobile
application.
IMPORTANT: To enable regular clinician review, it is recommended to keep the REMI
Smartwatch powered on and connected via Wi-Fi or cellular for at least 8 hours each day
throughout a recording session.

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Session Initialization
Session initialization occurs on the REMI Tablet. Once the REMI Tablet boots, it willautomatically display the Start Session Screen, as shown below. If the clock screen is shown,swipe up, which will display the Start Session Screen. Press the START button to begin a new
session. In the upper left-hand corner of the Start Session Screen is a “gear” icon which takes
you to the Application Settings Screen.
IMPORTANT: Only healthcare personnel at your facility should change any of the application
settings. Contact your IT representative listed on the screen for help.

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Enter Patient Information and Prescribed Session Duration
To enter patient information, touch the screen in the field MANUALLY ENTER PATIENT MRN.
This field is the patient’s medical record number. This action will bring up the Tablet
touchscreen’s alphabetic keyboard.

To switch to a numeric keyboard, click the “?123” button in the bottom left as shown in the circle
below.

To switch back to the tablet’s alphabetic keyboard, click the “ABC” button (which will
be located in the same position on the numeric keyboard). Likewise, to switch backto the numeric keyboard, click the “?123” button once again.

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Enter the patient’s medical record number (MRN), first name, last name, and prescribedmonitoring duration (in days) in the fields. Once patient information has been entered,click the NEXT button to proceed. You will also need to enter the duration of the study
on the tablet. The enter/return button on the tablet is displayed as a green > on thetablet keyboard.
IMPORTANT: The NEXT button will not appear unless all four fields are complete.

YYXXXXIMPORTANT: You may restart a session at any time by clicking the counterclockwise

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RESTART arrow in the upper left-hand corner of the screen and confirming. See Restart
Session and the End Session sections of this manual for further information.

REMI Sensor Preparation for Initial Placement
Retrieve Four REMI Sensors
REMI Sensors are packaged individually in a pouch and grouped in a single box with four
Sensors. You will need four Sensors for each recording session. Each Sensor has a uniqueserial number barcode and Sensor ID on the package labeling, as shown in the bottom image
below.

Scan this barcode for
Sensor ID

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Scan REMI Sensor Barcodes
Use the REMI Tablet rear camera to scan the barcode on each of the four Sensor packages asshown.
IMPORTANT: Only scan the barcode at the bottom of packaging. The QR code in the top left is
not scannable by the REMI Tablet.
Acquiring the Barcode
Center the barcode on the screen. Move the Tablet closer or further away from the barcode to
fill the screen with the barcode image. The Tablet will automatically read each barcode. Once
the Tablet detects the barcode a blue circle will fill and the first three alpha-numeric digits of theserial number, which is the same as the Sensor ID, will appear in green text below the circle.
The barcode of each Sensor can only be scanned once to prevent duplication.
If a barcode is not scanning or did not scan correctly due to issues such as damaged packaging
or camera, manually enter the Sensor ID, located on the Sensor packaging, using the keyboard
as described earlier. After entering the Sensor ID using the keyboard, select the enter/returnarrow to save the ID and move to the next Sensor. REMI Mobile will automatically move to
Sensor Initialization once all four Sensor IDs have been entered.

IMPORTANT: If you have manually entered a Sensor ID and wish to return to the barcode
scanning, click anywhere in the text field that says SCAN OR MANUALLY ENTER SENSOR ID
FROM PACKAGE.

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Touch anywhere in this field totoggle between manual entry andbarcode scanning.

REMI Sensor Replacement
If incorrect Sensor identifying information was entered, it can be replaced by clicking the blue
circle above the Sensor ID, which will bring up a Replace Sensor message box, as shown below.
Selecting “REPLACE SENSOR XXX” will remove the incorrect information, allowing you to reenter or rescan the correct Sensor identifying information. In the following example, a Sensor with
the ID “B61” is being replaced.

REMI Sensor Initialization
●
●
●

●

Remove the contents of each Sensor pouch.
Remove the Sensor from the pink protective covering.
Bring the Sensor close to the Tablet and press the center button on REMI Sensor toactivate, as demonstrated on the screen.
o Once the button has been pressed, the Sensor LED (near the four gold pins) will flash
blue three times followed by green twice to indicate that the Sensor is functioning
properly and activating.
Each Sensor will then wirelessly connect to the REMI Tablet. Note that it may take a

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●●●number of seconds for each Sensor to connect to the REMI Tablet.
When the Sensor connects to the REMI Tablet, the circle above that Sensor ID will fill green
and its LED will flash green 10 times.
Repeat these steps until all four Sensors have been activated. In the following example, one
Sensor (“8DA”) has connected to the Tablet. Sensors with the IDs “C41”, “847”, and “48F”
have not yet connected to the REMI Tablet.
When all four Sensors activate and connect to the REMI Tablet, the text will change from
PLEASE WAIT to NEXT. Click the NEXT button to proceed. Note, it can take some time
between the last Sensor circle turning green and from PLEASE WAIT to NEXT.

IMPORTANT: If there is an issue with a Sensor, it should be replaced before a recording
session begins. See instructions for replacing a REMI Sensor.
IMPORTANT: A sensor can be replaced at any time during this step. To replace a sensor, tapand hold the circle assigned to the sensor in question, and wait for the modal to appear to
replace the sensor.
IMPORTANT: A Sensor can be checked at any time to verify it has been activated and is
working correctly. Press the button on the Sensor, similar to the step described above. The
Sensor LED will flash green once to indicate a functioning Sensor.
IMPORTANT: If the Sensor is activated and working correctly, but the circle does not fill green
in REMI Mobile, bring the Sensor closer to the REMI Tablet.
IMPORTANT: If a Sensor LED blinks red, this means the Sensor is not fit for use. Should thishappen, hold your finger on the circle indicating the missing Sensor and you will be prompted toreplace the Sensor with a new one.
IMPORTANT: Do not use a Sensor that does not flash green when the button is pressed. See
instructions for replacing a Sensor that does not flash green.
IMPORTANT: Clicking Sensors too quickly can sometimes cause the connection attempt
between REMI Mobile and REMI Sensor to fail. This can be avoided if you wait a few seconds

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between the first button press to activate the Sensors. If a Sensor is taking too long, try depressing
the button again. If any Sensor does not connect within 60 seconds, see the Troubleshooting
section of this manual.

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Sensor Placement
Applying a Sticker to REMI Sensor
REMI Sensors attach to the scalp with a one-piece conductive-adhesive Sticker.
●
●
●
●
●

Open a Sticker package and remove one of the two available Stickers.
Remove blue liner film from the Sticker.
Line up the clear hydrogels over the gold electrodes, visible through the clear film, on thebottom of the Sensor and firmly stick the Sticker’s exposed adhesive to the Sensor. Presssmoothly around the edges to ensure a good stick.
Remove the clear film from the Sticker without removing the Sticker from the REMI Sensor.
When this is complete for all four Sensors, click NEXT on the Tablet screen.

WARNING: Do not contaminate the Sticker. Sticker contamination can cause skin irritation andimproper attachment of Sensors to the scalp that may affect performance.
CAUTION: Ensure that the Sticker hydrogels are aligned over the gold electrodes. Failure to do
so will result in poor data quality.
CAUTION: Ensure that the blue liner side of the Sticker is applied to the Sensor. The clear linerside of the Sticker is intended for patient contact.

Applying REMI Sensor to the Scalp
Prepare the location on the scalp shown on the screen with the alcohol wipe provided in each
REMI Sensor pouch. Apply the Sensor in the location shown on the screen. If you accidentallyplace the Sensor in an incorrect location or a different location than what’s shown on the screen,
follow the instructions on the following page to Restart Placements (you may not need toremove the misplaced Sensor and/or Sticker in the process).

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Locating the REMI Sensor in REMI Mobile
Once the REMI Sensor has been placed on the scalp, press the center button to locate theSensor in REMI Mobile. The LED on the Sensor should flash blue 3 times followed by green 2times, signifying it is functioning properly. When the Sensor automatically reconnects to the
REMI Tablet, the circle “1” will fill solid green in REMI Mobile indicating that the Left Ear location
has now been located and connected. If this occurs properly, the button in the bottom right willchange from PLEASE WAIT to TEST. The Sensor can now be tested as described in Testing
REMI Sensor After Placement and Activation. Note, it may take some time between thecircle turning green and from PLEASE WAIT changing to TEST.
CAUTION: Do not place the Sensor over hair. The REMI Sensor is meant to be used below
hairline. Placing the Sensor over hair may result in improper attachment to the scalp that may
affect performance.
IMPORTANT: If you believe the Sensor is activated but the circle is not showing green in REMI
Mobile, the Sensor can be verified. Press the button on the Sensor, similar to the step describedabove. The Sensor LED will flash green once to indicate a functioning Sensor. If the Sensor isactivated and working, but the circle does not fill green in REMI Mobile, bring the Sensor closer
to the REMI Tablet.
IMPORTANT: Do not activate more than one Sensor at this step. Activating more than one
Sensor will bring up the Multiple Sensors Activated Alert error screen. If this occurs, theREMI Tablet will ask you to repeat the activation process. See instructions in the Multiple
Sensors Activated Alert section.
IMPORTANT: If there is an issue with a Sensor, it may be replaced before a recording session
begins. Touch any one of the circles that is not filled solid green to replace the Sensor. See
instructions for replacing a Sensor.
IMPORTANT: The Stickers are one-time use and will no longer be sticky enough to properlyattach the Sensor to the scalp if it has been removed once before. A Sensor may berepositioned on a patient if initial placement is not optimal, but Sticker adhesion should be
confirmed following repositioning. If the Sticker is no longer sticky enough, you will need to
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restart Sensor Placement.
IMPORTANT: You may restart and/or reset the Sensor placement at any time by clicking theRestart Placement button that looks like a counter-clockwise arrow in the upper left-hand cornerof the screen. See the Restart Placement section of this manual. If you placed the Sensor in
the incorrect location it will be possible to change locations later. See the Change Sensor
Placement section of this manual.

Restart Placement
If you have made a mistake at any time during the placement procedure, simply start over byclicking the Restart Placement button that looks like a counter-clockwise arrow in the upper lefthand corner of the screen. This will bring up a confirmation message box that asks if you would
like to restart the placement procedure. Touching outside of the message box boundaries orclicking CANCEL will take you back to the screen you were working from previously. Clicking
CONFIRM will take you back to the start of the placement and activation process beginning withthe placement behind the left ear.

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Testing Sensor After Placement and Activation
Once a REMI Sensor has been placed on the scalp and connected, it is now time to test Sensor
Electrode Contact Quality (ECQ). Touch the TEST button on the bottom right of the REMI
Mobile Sensor Placement Screen.

The REMI Tablet will instruct the REMI Sensor to test the ECQ between the Sensor and thescalp. If the ECQ is good, the Sensor will flash its LED green 10 times; REMI Mobile willautomatically reset the TEST button to PLEASE WAIT and change the left image to thenext Placement location. If the ECQ is bad, an alert will appear. Please see the Poor
Electrode Contact Alert section. Repeat the Placement and Testing procedure for the Left

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Forehead, Right Forehead, and Right Ear locations as instructed by REMI Mobile.

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Sensor Sync
REMI Mobile will automatically synchronize all connected Sensors once all placement andtesting procedures have been completed. This process may take several minutes. A message
box will appear to indicate that Sensors are syncing.
●If you wish to cancel a session before syncing is complete, touch the HIDE button to remove
the Syncing message box and then click the CANCEL button. Once you have clicked the
CANCEL button, click the CONFIRM button to end the session and start over from the
beginning.

Once all Sensors have synced, the message box will disappear allowing you to proceed to
Session Verification.
IMPORTANT: The Syncing message box serves as a status indicator for the sync
process. It is not recommended to “hide” the Syncing message box while Sensors
are syncing or you will not be able to view sync status.

IMPORTANT: If there is an issue with sync, you may be instructed to replace a
Sensor before continuing to Session Verification. See the Replace Sensor section of thismanual.

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Session Verification
Verify that all patient and Sensor information is displayed correctly on the Verify Session Screen
shown below.

●

Ensure patient name is correct. If patient name is incorrect you must click CANCEL and then
CONFIRM to end the session and start over from the beginning. See the End Sessionsection of this manual for details.

Check to ensure each Sensor is in the correct location on the patient. Each Sensor is depictedby its three-digit alpha-numeric Sensor ID number. If you are unsure of the location, it ispossible to “locate” a Sensor by instructing it to flash its LED green. See the Identify Sensor
section of this manual. Note, identifying placement, changing placement, or replacing Sensors
are not a necessary step to begin recording. If all information has been entered correctly,
proceed to the watch handoff described in the REMI Smartwatch Handoff section in thismanual.
IMPORTANT: If two Sensors are in the wrong location it is possible to “swap” them in REMI
Mobile without having to remove the Sensors from the patient. See the Change Sensor
Placement Location section of this manual.
IMPORTANT: If a Sensor is not working properly, it is possible to replace the Sensor at thispoint. See the Replace Sensor section of this manual.

Identify Sensor
REMI Mobile may be used to identify the location of a REMI Sensor by flashing the Sensor LED
green. Click on the Sensor that you wish to identify in the head diagram on the screen. A“Sensor” window will appear as shown. Click IDENTIFY. REMI Mobile will communicate with theSensor to flash the LED green 10 times. The Sensor window will disappear and the Sensor in
the head diagram will turn solid green while the Sensor LED is flashing green. After the LED
flashes 10 times it will automatically stop and the Sensor in the head diagram on the display willgo back to solid blue.

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Change Sensor Placement Location
It is possible to change the placement location of a REMI Sensor only before a recording has
started. Click on the Sensor that you wish to change in the head diagram on the screen. A“Sensor” window will appear as shown above in Identify Sensor. Click CHANGE PLACEMENT.
The “Sensor swap” screen will appear, as shown below. You will then be able to choose which
other Sensor you would like to swap locations. Confirm Sensor swap by clicking CONFIRM or
click CANCEL or touch anywhere on the screen to return to the Verify Session screen withoutchanging Sensor placements. Swapping locations will reorder the location of the Sensors onhead diagram. Note, this only needs to be done once to swap two locations. You may also
click CANCEL on the Sensor swap screen or touch anywhere on the screen to return to the
Verify Session screen without changing Sensor placements. You can always verify that the
Sensors are now in the proper location. See Identify Sensor section of this manual for details.

Replace Sensor
It is possible to replace a Sensor that may be having issues such as connectivity, only before arecording has started. Click on the Sensor that you wish to change in the head diagram on thescreen. A “Sensor” window will appear as shown above in Identify Sensor. From the Sensor
Screen, click REPLACE, which will allow you to replace a Sensor as described earlier.

Restart Session
It is possible to restart the session and begin from the beginning at any time before a recording
has started. You may restart and/or reset the Session by clicking the Restart Session button
that looks like a counter-clockwise arrow in the upper left-hand corner of the screen. This will

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User Manual for REMI Ambulatory Usebring up the Restart Session window that will ask you to confirm or cancel the selection. Once
confirmed, all data will be cleared and you will return to the Start Session Screen.

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REMI Smartwatch Handoff
Prepare REMI Smartwatch for Handoff
Ensure that the REMI Smartwatch that will be used during the patient’s monitoring session is
powered on. The watch power can be turned on and off by holding the physical green button on
the right side of the watch. The REMI Smartwatch screen will sleep if left inactive for over one
minute. To reactivate the screen, press the physical green button on the right side of the watch.
If a clock is displayed on the screen, you will need to swipe up from the bottom of the screen toaccess the onboard REMI Mobile software.
The REMI Smartwatch must be provisioned before it can be used for a recording session. The
REMI Smartwart is properly provisioned if the watch face shows a Scan screen containing theWatch ID ((RW######) and a corresponding QR code. If the Watch ID and QR code are notshowing, please refer to the Provisioning Smartwatch discussion in the Troubleshooting
section of this manual.

YYXXXX
Completing the Handoff
To begin the handoff process to the watch, select the START SESSION ON WATCH button
from the Verify Session screen on the REMI Tablet.
After clicking the START SESSION ON WATCH button on the REMI Tablet’s Verify Session
Screen, the Scan Watch Barcode Screen will appear as shown.

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Use the REMI Tablet rear camera to scan the REMI Smartwatch QR Code.

IMPORTANT: Only scan the QR Code of the REMI Smartwatch that will be used for patientmonitoring.
Center the barcode on the screen. Move the Tablet closer or further away from the barcode to
fill the screen with the barcode image. The Tablet will automatically read each barcode. Once
the Tablet detects the barcode, the QR Code will populate the text field. If the QR Code is notscanning or does not scan correctly, manually enter the Watch ID, located on the REMI

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Smartwatch screen directly below the QR Code. Manual entry using the REMI Tablet keyboard
is described in the Acquiring the Barcode section of this document.
Enabling/Disabling Caregiver Controls
The Caregiver Controls is a feature that enables a caregiver to lock and unlock functionality
within the Smartwatch. To enable, toggle the setting to the right. The code to unlock the
Caregiver Controls is the last four digits of the Watch ID. The passcode will auto-populate after
the watch has been successfully scanned.

= Toggle Enabled= Toggle Disabled
Click on the CONNECT TO WATCH button on the REMI Tablet to begin the watch provisioning
process. After pressing the CONNECT TO WATCH button, the Watch Handoff Screen willappear on the REMI Tablet as shown below. Click on the HANDOFF button to initiate handoff.

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The REMI Smartwatch screen will update with sensor connection status once handoff
commences as shown below. The REMI Tablet screen will also show handoff status while
handoff is in process as shown below.

IMPORTANT: Try to maintain a distance less than 4m between the REMI Smartwatch, REMI
Tablet, and REMI Sensors to ensure successful and timely handoff. It is recommended tominimize the distance as much as possible for the most efficient handoff.
Once handoff is complete, the REMI Smartwatch screen will update to show that a recording
has transitioned to the watch as shown below. The screen shows current time, date, andpercentage of battery charge. The REMI Tablet screen will also show that the handoff iscomplete, and that recording has commenced on the REMI Smartwatch as shown below. Press
the DONE button on the REMI Tablet screen to restart REMI Mobile software in preparation fora future REMI monitoring session.

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REMI Smartwatch Wi-Fi Setup
To enable Wi-Fi, swipe RIGHT from the home screen to access the Options menu. Select the
WI-FI SETUP icon to access the Wi-Fi setup.

Select the preferred Wi-Fi network. The scanning step may take several minutes as available
Wi-Fi Networks might not appear until the network scan is complete. If the incorrect Wi-Fi
Network was selected, touch the “<” symbol next to the network name to return to the Wi-Fi
network selection screen.

Select ENTER PASSWORD to enable the onscreen keyboard. Enter the network password andclick the green > before pressing JOIN. You can select SHOW PASSWORD while entering
password to review input if needed.

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If the password entered is incorrect, the Smartwatch will give a PASSWORD INCORRECT error
message. Once the correct password has been entered, a check mark will appear next to the
Wi-Fi name on the Wi-Fi network selection screen.
CAUTION: REMI Sensors will record and store data from immediate placement until the end of
the prescribed duration, but must be within 10m of the REMI Smartwatch to wirelessly transmit
the data. It is recommended that the patient stay within 4m of the REMI Smartwatch for at least
8 hours a day. A suggested use is to set up the charging station near patient sleeping
arrangements.
CAUTION: The REMI Smartwatch must be powered on and connected to cellular and/orinternet in order to send data via REMI Cloud to the Clinician viewing platform. It is
recommended to set up the charging station in an area of reliable connectivity. When able tosuccessfully reconnect to REMI Sensors, the REMI Smartwatch will initiate a data catch-up
process at regular intervals, starting with the oldest missed recording data first.
IMPORTANT: The REMI Smartwatch should be connected to Wi-Fi to enable more reliable andconsistent connectivity.

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Logging a Seizure Event
The REMI Smartwatch is intended to handle a monitoring session throughout the patient’sprescribed monitoring duration. The REMI Smartwatch also provides a means to mark asuspected seizure event on the patient’s monitoring record. Press the physical silver button on
the right side of the REMI Smartwatch to activate the “Did a Seizure Just Occur?” screen as
shown below.

Press the NO button on the screen if the screen was unintentionally opened. Press the YES
button on the screen if a seizure event may have just occurred. If the YES button is pressed, theEvent Confirmed Screen will be displayed momentarily on the REMI Smartwatch.

Double clicking the physical silver button will also log an event without screen interaction.

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Sensor Sticker Replacements
Initiate Sensor Sticker Change
A REMI ambulatory monitoring session is intended to be completed over the course of aprescribed monitoring period. During the monitoring session, REMI Stickers will need to be
removed either once daily or at a patient’s discretion (e.g., to shower/bathe).
CAUTION: REMI Stickers should be replaced daily and REMI Sensors can only be used for asingle patient EEG recording session. Once a recording has ended all active Sensors will nolonger be able to connect to the computing platform or record EEG.
To change a Sticker, swipe to the right or to the left on the REMI Smartwatch screen. Swiping
will activate the Options Screen as shown. Press the CHANGE STICKERS button to begin a
sticker change process.

Two options are made available when selecting the CHANGE STICKERS button. Select the
ALL SENSORS button to change Stickers on all 4 Sensors or the ONE SENSOR button tochange the Sticker on a single Sensor. Once a button has been selected, step by step screens
guide you through each Sticker Change process.

Confirm Sticker Replacement
If you select All Sensors, you will then proceed to a confirmation screen. Select CONTINUE to

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proceed with the All Sensor Sticker Change and the Smartwatch will automatically begin
reconnecting to Sensors. Keep your Smartwatch close to your Sensors for the fastest
reconnection. Once your Sensors are successfully connected to your Smartwatch, proceed to
the next step to remove all Sensors from scalp.

IMPORTANT: Do not remove your Sensors until Sensors have successfully reconnected.
Failure to do so may cause damage to your Sensors and can cause issues to the recording.
If you are completing One Sensor Sticker Change, you will first need to select which Sensor’s
Sticker you are replacing. After selecting, you will be prompted for confirmation to complete theprocess in full.

IMPORTANT: If you have lost a Sensor or removed a Sensor from the session at any point,then you will not be able to select that Sensor during this process.

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Remove Sensor(s) from Scalp & Dispose of Used Sticker(s)For an All Sensor Sticker Change, remove all Sensors from your forehead and from behind yourears. For a Single Sticker Change, remove only the selected Sensor. Once removed, select
CONTINUE to remove Stickers.

IMPORTANT: If you need to remove Sensors for an extended period of time, initiate an All
Sensor Sticker Change and pause after removing Sensors and disposing of used Stickers. The
Smartwatch will stay on this screen until you are ready for the next step. It is recommended you
keep your Smartwatch on the charger if you plan to be gone for longer than 30 minutes.
Clean Scalp
When you are ready to continue with Sensor placement, prepare the Sensor location(s) on yourscalp with the provided alcohol wipe(s) (i.e., the same location(s) where the Sensors previously
positioned on your scalp).

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CAUTION: Do not place the Sensor over hair. The REMI Sensor is meant to be used below thehairline. Placing the Sensor over hair may result in improper attachment to the scalp that may
affect performance.
For an All Sensor Sticker Change, prepare the locations on your forehead and behind your ears.
For a Single Sticker Change, prepare only the selected location. Once all affected scalp
locations are prepared, select CONTINUE.

Place New Stickers on Sensors
You will then be instructed to PLACE STICKERS ON (ALL) SENSOR(S). REMI Sensors attach
to the scalp with a one-piece conductive-adhesive Sticker.

For an All Sensor Sticker Change, apply new Stickers to all four Sensors. For a Single Sticker
Change, apply a new Sticker to only the selected Sensor.
●●●

Open a Sticker package and remove the Sticker.
Remove blue liner film from the Sticker.
Line up the clear hydrogels over the gold electrodes, visible through the clear film, on thebottom of the Sensor and firmly stick the Sticker’s exposed adhesive to the Sensor. Presssmoothly around the edges to ensure a good stick.

When applying Stickers to Sensors, follow the next guide (ensuring that you removing the blue
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CAUTION: Ensure that the blue liner side of the Sticker is applied to the Sensor. The clear linerside of the Sticker is intended for patient contact.
Select NEXT after Sticker(s) have been placed on all selected Sensor(s).

Identify Sensor for Placement
For an All Sensor Sticker Change, press the button on any Sensor to identify the Sensor anddetermine its scalp placement location. Then select NEXT and wait for the Sensor to respond.
This step does not apply to aSingle Sticker Change.

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Remove Second Liner and Place Sensor
You will then be prompted to remove the second Sticker liner and place the Sensor in thespecified location. Remove the liner per the next guide:The message will also inform you of the location for the Sensor and display an image of thatlocation. Place the Sensor at the location instructed on the Smartwatch. After you are satisfied
with the placement of the Sensor, select NEXT to continue.

Note: In this example, the Sticker is for LEFT EAR. This same set of instructions will be
provided for each Sensor as it is placed on the scalp during an All Sensor Sticker Change.

Activate Sensor after Placement
After placement on the scalp, press the button on the Sensor again, then select NEXT.

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Allow time for the Smartwatch to reconnect to the Sensor. The Sensor and Smartwatch will thenstart to connect automatically. The next screens will progress without interaction. Wait while theSmartwatch screen displays the following two screens.

The system will alert you if the Sensor has poor contact, and you will be prompted to checkplacement, replace the Sticker, and retest that Sensor. If completing a Single Sensor Sticker
Change, the process is complete once this Electrode Contact Quality (ECQ) test is successful.
Select DONE and you will be returned to the “IN SESSION” screen.

If completing an All Sensor Sticker Change, the process will continue following successful ECQ
testing. The Smartwatch will guide you through the second Sensor application and testing by
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User Manual for REMI Ambulatory Userequesting you to PRESS BUTTON ON NEXT SENSOR. Follow the screens until all Sensors
have been replaced.

Once the final Sensor has been placed, the Smartwatch will send a final sync message toensure quality of recording. During this step, it is important that you stay next to your
Smartwatch. The sync process is complete when the screen displays the message STICKERREPLACEMENT COMPLETE. Select DONE and you will be returned to the “IN SESSION”
screen.

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End of Session Process
After your prescribed session length, the Smartwatch will initiate its end-of-session activities.
The Smartwatch will notify you of the session completion, instructing you to keep the
Smartwatch turned on and charging, and to store the Sensors next to the Smartwatch.
The system is in its final processing stage. Avoid interacting with the Smartwatch or Sensors,and be advised that this process may take up to 5 days.

CAUTION: DO NOT DISPOSE OF THE SENSORS. Ensure the Smartwatch stays connected
and powered on during the end-of-session screen.
After final processing has completed, you will receive a final SESSION COMPLETE message.
Please power down the Smartwatch and return it along with all Sensors to your clinician or theirprescribed destination at your earliest convenience.

CAUTION: REMI Sensors and Stickers are single-patient, one-time use. Do not attempt toreuse REMI Sensors or Stickers. Once a recording has ended all active Sensors will no longer
be able to connect to the REMI Smartwatch or record EEG.
IMPORTANT: You may be prompted to replace a sensor sticker during the duration of wearing
the sensors. Follow the guided instruction to remove sensors and replace stickers. At
prescribed intervals, normally every 24 hours, the watch will automatically request that “All
Stickers” be changed. While this may be delayed, it is advised that stickers be replaced atthese 24 hour intervals.
IMPORTANT: Ending a recording will permanently disable REMI Sensors. After ending a

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recording, the Sensors connected to the REMI Smartwatch will no longer be able to record orconnect to the REMI Smartwatch.
End Session Before Prescribed Duration Complete
If you need to end a session on the watch earlier than the prescribed duration, you can do sousing the “End Session” functionality within the application. Access the Options Menu, andselect “End Session” from the list of actions.

After selecting “End Session”, you will be prompted to provide a passcode. The passcode forthis functionality is the same across all REMI Smartwatches: 7364 (REMI).

If you mistype the passcode, the device will inform you and allow you unlimited attempts tocorrectly enter the passcode. Selecting the <- back arrow will take you back to the Options
Menu.
After successfully entering the correct passcode, you will be prompted with a confirmation toend the session ahead of the prescribed duration.

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“Back” returns you to the Options Menu. “End Session” will disable the sensors and end therecording for the session.

IMPORTANT: If you choose to end the session early, the sensors will no longer record EEG
data and the Smartwatch will no longer pull any missing data from the sensors. Thisfunctionality is only recommended if a fully recorded session is no longer necessary.

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REMI Mobile Warning Alerts
Notice of Open Warning Alerts
If the system experiences any system notifications, you will be alerted through the REMI Mobile
user interface as shown below. Selecting the screen takes you to information on the warning
alert that triggered the notices.

In the case of multiple notices at once, you will be informed of the count of open notices andreview all open notices at the moment. Selecting the screen takes you to a summary of all open
notices. From there, you can navigate to the details of each individual alert.

Sensor Disconnect – During Sticker Change

During a Sensor Sticker Change, a Sensor may have difficulty reconnecting with the
Smartwatch. This may occur during the Sensor Placement and Time Sync steps. Consider
moving the REMI Smartwatch closer to a disconnected Sensor to facilitate reconnection before
completing the in-app troubleshooting.
If the Sensor is unable to reestablish connection, the in-app workflow will remove the Sensor

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from the recording. The overall recording will continue with the remaining connected Sensors,
but you will not be able to use that Sensor again. Set the disconnected Sensor aside until theend of your session and return it with your Smartwatch and all other Sensors.

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Sensor Disconnect – Prior to Handoff

A REMI Sensor may disconnect from the REMI Tablet before an active recording begins. The
alert screen will appear with the options to replace the Sensor that has disconnected or end thesession, as shown. To replace the Sensor, click REPLACE (sensor ID) and then CONFIRM.
This will direct you back to entering a new Sensor ID as described in the REMI Sensor
Activation section earlier.
CAUTION: REMI Sensor wireless range is a maximum of 10m, and it is recommended that thecomputing platform be kept within 4m of the patient to ensure a good BLE connection between
the Sensors and the computing platform.
IMPORTANT: You will not be able to proceed through the Initialization process until the Sensor
has re-established a connection with the REMI Tablet if the alert screen is active before arecording has begun.

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Multiple Sensors Activated on the REMI Tablet

The Multiple Sensors Activated Alert Warning will appear if you activate more than one Sensor
while placing Sensors on the scalp during the Sensor Placement procedure. The REMI Tablet
will automatically turn off the conflicting activated Sensors and ask you to repeat the current
placement. The SNOOZE button will appear when the REMI Tablet has reset the Sensors.

Click SNOOZE and follow the steps on the REMI Mobile app. Note, if you placed a Sensor on
the scalp in the location shown already then you do not need to remove it. Simply press thecenter button again to activate. Follow the steps in the app as normal.

REMI Mobile Connectivity Failure

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REMI Mobile must be connected via Wi-Fi or cellular to transmit EEG data to the REMI Cloud.
Ensuring good connectivity will ensure EEG data is available for clinician review. Should thecomputing platform lose connectivity, an alert screen will appear, and all REMI Sensors will
begin to flash their LEDs alternating red and blue. Note, you may need to move the computing
platform to a different location if REMI Mobile continues to lose connectivity. Should thecomputing platform reconnect to Wi-Fi or cellular, the alert screen will automatically disappear.
CAUTION: EEG data will not be transmitted by the computing platform or available for clinician
review during the time that disconnection occurs.
IMPORTANT: You will not be able to proceed through the Initialization process on the REMI
Tablet until the connectivity is re-established if the REMI Tablet loses connectivity before arecording has started.
IMPORTANT: The REMI Tablet alert screen will have the information of the IT person to contact
at your institution including name, phone number, and email address. Contact Epitel Customer
Support or IT if this alert persists.

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REMI Cloud Server Error on the REMI Tablet

The REMI Cloud Server must be functioning for the REMI System to function properly. Should
the REMI Cloud Server have an error, an alert screen will appear, as shown, and all REMI
Sensors will begin to flash their LEDs alternating red and blue. Should the error end, the alert
screen will automatically disappear.
IMPORTANT: You will not be able to proceed through the Initialization process until the REMI
Cloud Server Error is discontinued if the error occurs before a recording has started.
IMPORTANT: The alert screen will have the information of the IT person to contact at yourinstitution including name, phone number, and email address. Contact Epitel Customer Support
or IT if this alert persists.

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Poor Electrode Contact

REMI Mobile will check the Electrode Contact Quality (ECQ) when the user clicks TEST after
the placement of each Sensor. An alert will be displayed with troubleshooting advice if a Sensor
has poor ECQ, with the option to SNOOZE or END SESSION, as shown above. SNOOZE canbe chosen to close the alert, re-activate the Sensor, and then retest the Sensor.
If a Poor ECQ message box appears, it is recommended that you replace the Sticker andreapply the Sensor in the same location on the scalp, ensuring to place the Sensor as close to
below the hairline as possible so that the clear hydrogels make good contact between the scalp
and the gold electrodes on the Sensor.
On REMI Tablet, if there are still issues with the Sensor ECQ after re-testing, the Sensor can be
replaced by clicking REPLACE (which will be where SNOOZE is shown above). END SESSION
can always be chosen to end the session and return to the Start Screen.
IMPORTANT: During initial placement on the tablet, a Sensor can only be re-tested once. If theSensor still has poor ECQ after the second test, replacing the Sensor is the only option.

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IMPORTANT: During an active session on the Smartwatch, a user will be informed if poor ECQ
occurs. The Smartwatch will prompt the user to start a Single Sensor Sticker Change on theimpacted Sensor. If poor ECQ is detected during the sensor sticker change, the Sensor andSticker ECQ can be re-tested. If ECQ is not resolved through these initial tests, the user will beprompted to replace the Sticker one more time. If poor ECQ continues after this troubleshooting,
the Sensor will be deemed not fit for use and will be removed from the session.

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Low Battery
It is recommended that the REMI Tablet be plugged into A/C power at all times. Should thebattery reach 50% capacity or less and is not plugged into A/C power, an alert screen willappear. All REMI Sensors will begin to flash their LEDs alternating red and blue. If REMI Tablet
battery power is above 25% you will be able to “snooze” the alert screen.
IMPORTANT: If the Tablet Battery Low alert appears prior to start of recording, you will not beable to proceed through the Initialization process. Plug the REMI Tablet into A/C power toautomatically turn off the Tablet Battery Low alert.
IMPORTANT: The alert screen will have the information of the IT person to contact at yourinstitution including name, phone number, and email address. Contact IT if this alert persists.

For optimal performance, the REMI Smartwatch is recommended to be plugged in whenpossible. The REMI Smartwatch will also operate on battery power. Once the Smartwatch
battery drops below 25% capacity an alert will pop up on the REMI Mobile application.

IMPORTANT: The REMI Smartwatch operates most efficiently when properly charged. To
confirm that the device is properly connected to the charger, the Smartwatch screen will show acharging status.

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Bluetooth Error on REMI Tablet

There may be times that the REMI Tablet has issues communicating with the sensor and theBluetooth Error alert screen will appear as shown above. If this occurs, follow the instructions in
the alert to reboot the REMI Tablet. The REMI Mobile application will pick back up where it leftoff, after the reboot. If unresolved, it may be necessary to have IT personnel enter the Settings
screen to turn on Bluetooth connectivity.

REMI Tablet Settings

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The settings screen provides the REMI Mobile software version number along with regulatory
information and connectivity information for the REMI Tablet and Sensors. The institution’s IT
Contact information can be modified on this screen.
IMPORTANT: Device Configuration information should not be changed without the support of
Epitel and your hospital’s IT department, as this may affect REMI Tablet connectivity.

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Accessing Session Diagnostic Information for Customer Support
You may want to discuss an ongoing session with Epitel Customer Support. If Epitel Customer
Support asks you to provide additional REMI session information, you may obtain this information
within the Options menu. Swipe RIGHT from the home screen to access the Options menu, thenscroll to the bottom of the menu to view Additional Info, where the Watch ID, REMI Mobile software
version number, and Session ID are provided.

Hiding the Options menu can be done by clicking the BACK button.

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Persyst™ Mobile for EEG Review
REMI has been qualified for use with FDA-cleared Persyst Server and Persyst Mobile software
to provide remote viewing of EEG. Persyst Mobile works on any desktop internet browser or on
mobile devices. To access patient EEG, log into the Persyst Mobile web address, which will look
like the screen below. The web address and your credentials are available from your health care
network administrator.

Once logged in, a list of Patient Names will appear, similar to the following image. Patients withactive recordings will have a green square box to the left of their name. The patient name and
MRN (ID) are displayed.

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Clicking on a patient name on the left side of the screen will highlight that patient and list thecurrent end and beginning of the patient recording as comments on the right side of the screen,
as shown above. Clicking either of the comments will bring up the patient’s EEG record,
displayed in the REMI 10-channel montage, similar to the image on the following page. All
settings for the display can be configured by clicking the gears icon in the upper right of thescreen.
IMPORTANT: Any data missed due to issues such as REMI Sensor disconnections is displayed
as zero-value data in the Persyst display.

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User Manual for REMI Ambulatory UseTroubleshooting
A REMI Sensor continuously disconnects from the REMI Tablet – Ensure the REMI Tablet
is close enough to the patient to properly connect. We recommend replacing the REMI Sensor if
the disconnection continues and a recording has not yet been started. See the Replace Sensor
section of this manual. Note that a recording session will continue even if a REMI Sensor is nolonger functioning properly.
A REMI Sensor will not connect to the REMI Tablet – It may be necessary to replace a
Sensor prior to starting a recording if it fails to connect to the REMI Tablet. We recommend
using a different Sensor. The unused Sensor that is not connecting to the REMI Tablet can be
returned to Epitel for replacement. See Warranty section of this manual.
A REMI Sensor has fallen off the patient – In the case that a Sensor has fallen off of the scalp
after a recording session has started, the user should initiate a Single Sticker Change as
described in the Single Sticker Replacements section of this manual.
REMI Tablet is unresponsive – Attempt to restart the Tablet by pressing and holding thepower button and clicking Reboot. It will take a few seconds to reboot; however, the REMI app
will take you back to the screen where you left off. If the Tablet continues to be unresponsive,please contact Epitel Customer Support or IT.
The REMI Tablet will not boot – Ensure the Tablet is plugged in to A/C power before trying toboot the Tablet. It may be that the battery has drained and needs time to recharge to run onbattery power. We recommend keeping the REMI Tablet plugged in to A/C power during use
and while in storage.
REMI Smartwatch is unresponsive – Attempt to restart the Smartwatch by pressing andholding the physical green button on the right side of the watch. It will take a few seconds toreboot; however, the REMI app will take you back to the screen where you left off. For example,
if the Smartwatch becomes unresponsive during an active recording, it will restart, reconnect
with all REMI Sensors, and continue recording. If the Smartwatch continues to be unresponsive,please contact Epitel Customer Support.
The REMI Smartwatch will not boot – Ensure the Smartwatch is plugged in to A/C power
before trying to boot the Smartwatch. It may be that the battery has drained and needs time torecharge to run on battery power. If the Smartwatch continues to be unable to boot, pleasecontact Epitel Customer Support.
The Wi-Fi and/or cellular connection is intermittent – It may be necessary to find a physicallocation in the room where both Wi-Fi and/or cellular and a connection between the REMI
Tablet and REMI Sensors is reliable. We recommend that if there are Wi-Fi and/or cellular“dead spots” in the room that the patient be moved to a location where Wi-Fi and/or cellular ismore reliable. If Wi-Fi and/or cellular continues to be intermittent, contact IT.

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The REMI Sensor barcode will not scan – Barcodes can be difficult to scan in low-light
conditions, if the barcode was damaged or scratched, or if the barcode is incomplete. If thebarcode is difficult to scan, we recommend manually entering the REMI Sensor ID using the
REMI Tablet touchpad keyboard. See the REMI Sensor Activation section of this manual.
Note, once a Sensor barcode has been scanned the REMI Tablet will not allow you to rescan
the barcode. Make sure you have not already scanned the REMI Sensor barcode. If the REMI
Sensor ID appears below one of the filled blue circles, then that Sensor barcode has alreadybeen scanned or entered.
The REMI Smartwatch QR code will not scan – If the QR code is difficult to scan, we
recommend manually entering the REMI Smartwatch ID using the REMI Tablet touchpad
keyboard. See the REMI System Used in Ambulatory Settings section of this manual.
The REMI Sensor does not flash when I press the button – Ensure you are looking towards
the corner where the LED is located on REMI Sensor when pressing the button (next to the fourgold pins). Note, it can be difficult to observe the LED in bright lighting conditions. If the Sensor
still does not flash when the button is pressed and a recording has not yet been started, werecommend replacing the Sensor. See the Replace Sensor section of this manual. If theSensor still does not flash when the button is pressed after a recording has been started, werecommend first trying to use the REMI Tablet to Identify the Sensor. See Identify Sensor
section of this manual. If identifying a Sensor fails to flash the LED, we recommend either
ignoring or removing the Sensor that continues to disconnect after a recording has been started.
Note that a recording session will continue even if a Sensor is no longer functioning properly.
I mixed up the locations of where I placed the REMI Sensors – It is possible to relocate
REMI Sensors before a recording has started. See Change Sensor Placement section of thismanual. Note, do not try to reposition a REMI Sticker. Stickers are one-time use and will nolonger be sticky enough to properly attach the Sensor to the scalp if they have been removed
once before. A Sensor may be repositioned on a patient if initial placement is not optimal, but
Sticker adhesion should be confirmed following repositioning. If the Sticker is no longer sticky
enough, you will need to restart Sensor Placement.
The REMI Smartwatch displays a yellow triangle with an exclamation mark – A yellow
triangle with an exclamation mark indicates an error within the recording device. Swipe from rightto left and follow the in-app instructions to resolve the error.

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User Manual for REMI Ambulatory UseBefore Handoff, the Smartwatch does not display a Watch ID and QR Code – If a QR is notshowing on the watch screen, the Smartwatch may not be properly provisioned. You may see acamera screen or a prompt to allow for accessibility. If the Smartwatch is requesting camera
access, select the “Accept” button and then the watch camera will be activated. You can thenprovision the Smartwatch by using the camera on the top of the watch face to scan the QR codein the watch packaging as shown below.

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EMC Compliance
The 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 the home. To
prevent RF interference with or from the REMI System, portable and mobile RF communications
equipment should be kept away from the REMI components at distances specified in Appendix
B.

FCC Intentional Radiator Certification
FCC ID: 2AVPHEPGD1REMI Tablet FCC ID: 2AJZP-G450A1
REMI Watch FCC ID: 2AJZP-A4100
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 harmful interference, and (2) thisdevice must accept any interference received, including interference that may cause
undesirable operation.
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. This equipment generates, uses and canradiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee thatinterference will not occur in a particular installation. If this equipment does cause harmfulinterference to radio or television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of the following
measures:- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver isconnected.
- Consult the dealer or an experienced radio/TV technician for help.
NO MODIFICATION: Modifications to the Sensor shall not be made without the written consent
of Epitel, Inc. Unauthorized modifications may void the authority granted under Federal
Communications Commission rules permitting the operation of this device.

Wireless Communication
The REMI System uses Low Energy Radio Frequency (RF) operating at 2.45 GHz (maximum
1mW) for wireless communication between REMI Sensors and the REMI Tablet. Sensor
wireless range is a maximum of 10m, and it is recommended that the REMI computing platformt be kept within 4m of the patient to ensure a good wireless connection between the Sensors
and the computing platform. The REMI Mobile software will alert the user if there are
disconnection issues (see REMI Mobile Warning Alerts section). If this occurs, bring thecomputing platform closer to the patient to re-establish wireless connection between the
Sensors and REMI Tablet. A recording session will not be able to be started until all four
Sensors have a good wireless connection to the computing platform through the REMI Mobile
software. If a Sensor is unable to establish this connection during session initialization, theSensor can be replaced (See the Replace Sensor section of this manual).

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The REMI System uses the hospital or home Wi-Fi connection and/or a cellular connection for
wireless communication between the REMI Mobile and the REMI Cloud platform.
● REMI Tablet connectivity will be set up and tested initially by the hospital administration
IT department alongside Epitel staff.
● REMI Smartwatch communicates natively via cellular connection and can be configured1) by hospital administration IT department alongside Epitel staff to connect to hospital
Wi-Fi and 2) by the patient / caregiver to communicate via a home Wi-Fi network.
The REMI Mobile software will alert the user if there are any disconnection issues during theuse of the REMI System (see REMI Mobile Warning Alerts section). If connectivity cannot beestablished or continues to have issues, notify hospital IT staff immediately and/or discontinueuse of the REMI System. Only the hospital IT staff can alter the connectivity settings on the
REMI Tablet.
The REMI System complies with the IEEE C63.27-2017 American National Standard for
Evaluation of Wireless Coexistence standards. To prevent RF interference with or from the
REMI System, portable and mobile RF communications equipment should be kept away fromthe REMI components at distances specified in Appendix C.

Cybersecurity
REMI Sensor wireless communication with REMI Mobile software is secured through singledevice proprietary connection protocols. There are no specific user instructions for the Sensor
that pertain to Cybersecurity controls. Once a Sensor is packaged and sent to the user, theSensor firmware and connection protocol cannot be changed or altered by the user. If a problem
occurs with the wireless communication between the Sensor and REMI Mobile, the REMI
Mobile software will alert the user (see REMI Mobile Warning Alerts section). There is nopatient identifying information communicated between REMI Mobile and REMI Sensors.
The REMI Mobile software communicates with the REMI Cloud platform using an encrypted
protocol via a Wi-Fi network and/or a cellular network.
● All REMI Tablet wireless communication settings are configured by authorized Epitel
personnel and hospital administration IT professionals during initial REMI setup andinstallation. These settings are password-protected, and they must not be altered byanyone outside of the hospital administration IT department.
● REMI Smartwatch communicates natively via cellular connection and can be configuredby the patient / caregiver to communicate via a Wi-Fi network.
If a problem occurs with the wireless communication between a qualified computing platform,
the REMI Mobile software will alert the user (see REMI Mobile Warning Alerts section). REMI
Mobile only operates on dedicated qualified computing platforms. Only REMI Mobile isaccessible to the platform user, and no attempt should be made to access and install any othersoftware or alter any system-level settings on the computing platform.
The REMI Cloud platform runs on the Amazon Web Services™ (AWS) cloud platform andfollows AWS best practices for HIPAA security and compliance, including end-point protections
and limited/secured user access. Access to patient data via Persyst Mobile running on the REMI
Cloud platform is password protected. Reviewing physicians should not share their passwords
with anyone. Should a reviewing physician’s password become compromised, please alert
hospital administration immediately, who can then notify Epitel.

Server Maintenance
The REMI Remote EEG Monitoring System uses the REMI Cloud Server to store data and
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operate Persyst™ Mobile. The REMI Cloud Server runs on the Amazon Web Services (AWS)
cloud platform and follows AWS best practices for HIPAA security and compliance, including
end-point protections and limited/secured user access.
To ensure continued operation of the REMI Cloud Server, Epitel performs routine server
maintenance according to a server maintenance plan. Under this plan, routine maintenance will
be performed up to once monthly. During routine service maintenance, you can expect to see abrief loss of server connectivity for a brief time (but no longer than 60 minutes). This may resultin brief loss of patient data during the outage (while the REMI Cloud Server reboots) and/or
inability to review EEG data collected during the outage.
Once routine server maintenance is completed, connectivity between REMI Mobile and the
REMI Cloud Server will be seamlessly restored.
In the event that critical server maintenance is required, Epitel will communicate with hospital IT
administrators to alert them of potential outages and to ensure that there are no negative
impacts to patient care. Critical server maintenance may require additional planning to ensurethat EEG monitoring sessions are not impacted.
For any questions related to REMI Cloud Server routine maintenance, contact your Epitel
customer service representative.

REMI Tablet and REMI Smartwatch Service and Repair
The REMI Tablet and the REMI Smartwatch do not require any scheduled maintenance, system
checks, or calibration. For servicing information or to return your REMI Tablet or REMI
Smartwatch for repair, contact your Epitel customer service representative.

REMI Mobile Updates
Whenever software updates to the REMI Mobile application become available (whether due tocybersecurity enhancements, feature enhancements, resolution of anomalies, etc.), Epitel will
coordinate with hospital staff and IT administrators about the impact of the updates so that staff
may determine whether to accept the update, and will assist in implementing all chosen
updates. Following notification and coordination, REMI Mobile application updates will be
deployed by Epitel.

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Sensor Specifications
Compliance Standards
Degree of Protection
Ingress Protection
Operation Environment

Storage Environment

Transport Environment

Storage Duration
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 andgreater. Protected against the effects of temporary immersion in water.
REMI Sensors have been tested for operation environments of 37°F to
100°F (3°C to 38°C), 10 to 95% relative humidity (non-condensing), 525
to 795 mmHg (700 to 1060 hPa)REMI Sensors have been tested for storage environments of -9°F to
154°F (-23°C to 68°C), 10 to 95% relative humidity (non-condensing).
REMI Stickers have been tested for storage environments of 50°F to
104°F (10°C to 40°C), 10 to 95% relative humidity (non-condensing)
REMI Sensors have been tested for transport environments of -9°F to
154°F (-23°C to 68°C), 10 to 95% relative humidity (non-condensing).
REMI Stickers have been tested for transport environments of 50°F to
131°F (10°C to 55°C), 10 to 95% relative humidity (non-condensing)
REMI Sensors, including their REMI Stickers, have a limited shelf-life
defined on the package labels.
REMI Sensors are capable of collecting and transmitting data for aminimum of 48 hours.

REMI Mobile Qualified Operating Systems
REMI Mobile has been developed and qualified for use on Android operating systems. See
REMI Mobile Updates above for a description of how Epitel manages updates.
Computing Platform

Computing Platform Operating Systems

REMI Tablet

Android 11 or higher

REMI Smartwatch

Wear OS 3.0 or higher

Product Cleaning
The REMI Tablet and REMI Smartwatch should only be cleaned with damp cloths using water,
alcohol (70%) or bleach (1.5-2.0%) and should not be immersed in any liquids or gases.
Cleaning of REMI Tablet and REMI Smartwatch should be done between each patient use.
REMI Sensors should only be cleaned with damp cloths using water and should not be
immersed in any liquids or glasses. If desired, REMI Sensors may be cleaned when performinga Sticker exchange.
CAUTION: REMI Sensors and Stickers are single-patient, one-time use. Do not attempt toreuse REMI Sensors or Stickers.

Product Returns
All components of the REMI System that require repair, replacement, or end-of-life recycling
should be returned to the address below, only after receiving an MRA number from Epitel
Customer Support (support@epitel.com). Sensors should be shipped to Epitel in secure, antistatic, padded packaging. Epitel recommends that users keep all original packaging in case of
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repair or maintenance needs.
Epitel Returns
465 S. 400 E. Suite 250
Salt Lake City, UT 84111
support@epitel.com
www.epitel.com
For questions or comments call (801) 497-6297.

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Appendix A – Electromagnetic Emissions Declarations
Declaration – Electromagnetic Emissions

REMI is intended for use in the electromagnetic environment specified below. The customer orthe user of REMI should assure that it is used in such an environment.
Emissions test

ComplianceElectromagnetic environment –guidance

RF emissions CISPR 11

Group 1REMI disposable Sensors must emit
electromagnetic energy to perform its
intended function. Nearby electronicequipment may be affected.

RF emissions CISPR 11

Class B

REMI disposable Sensors are suitablefor use in all establishments, including
domestic establishments and those
directly connected to the public lowvoltage power supply network that
supplies buildings used for domestic
purposes

Harmonic emissions IEC
61000-3-2

Not
applicable

Voltage fluctuations/flicker
emissions IEC 61000-3-3

Not
applicable

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Appendix B – Electromagnetic Immunity Declarations
Declaration – electromagnetic immunity
REMI Sensors are intended for use in the electromagnetic environment specified below. The
customer or the user of REMI should assure that it is used in such an environment
Immunity test

IEC 60601
test level

Compliance
level

Electromagnetic
environment – guidanceElectrostatic
discharge (ESD) IEC
61000-4-2± 8 kV contact± 15 kV air± 8 kV contact± 15 kV air

Floors should be wood,concrete, or ceramic tile. If
floors are covered withsynthetic material, the relative
humidity should be at least
30%.

Power frequency (50/60
Hz) magnetic field IEC
61000-4-8

30 A/m30 A/mPower frequency magnetic
fields should be at levels
characteristic of a typicallocation in a typical commercial
magnetic field or hospitalenvironment
Portable and mobile RFcommunications equipment
should be used no closer to any
part of REMI, including cables,
than the recommended
separation distance calculated
from the equation applicable tothe frequency of the transmitter.

3 Vrms150 kHz to 80
MHz

Recommended separation
distance:
Conducted RF IEC
61000-4-6

Radiated RF IEC
61000-4-3

3 V/m
80 MHz to 2.7
GHz

Not applicabled = 1,2P

3 V/m
80 MHz to 2.7
GHz

d = 1,2

P 80 MHz to 800 MHz

d = 2,3

P 800 MHz to 2,7 GHz

where P is the maximum
output power rating of thetransmitter in watts (W)according to the transmitter
manufacturer and d is therecommended separation

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distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by anaelectromagnetic site survey,
shouldbe less than thecompliance level in eachbfrequency range, Interference
may occur in the vicinity ofequipment
marked with thefollowing symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation isaffected by absorption and reflection from structures, objects, and people.
aField strength from fixed transmitters, such as base stations for radio (cellular/cordless)telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which REMI is used exceeds the applicable RFcompliance level above, REMI should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or
relocating REMI.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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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 withany other antenna or transmitter.

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Appendix D – 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 CR2016 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: 1
Sample Rate:
256 HzRecording Range:± 500 µV, 12-bit
Amplifier Passband:
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
Hydrogel over hard gold electrode

LED Status Indication – Button Press
No LED or 2 x Red
Sensor error
3 x Blue then 2 x Green
Sensor activated and waiting for connection
1 x Green
Sensor working correctly
5 x RedSensor retired (no wireless connection allowed)
LED Status Indication – Without Button Press
10 x Green
External command used to identify Sensor
Continuous Red & Blue
User alert used to notify user that an error occurred. Review the
instructions on the computing platform and/or the Troubleshootingin this manual.

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Appendix E – Warranty
Epitel warrants to the original purchaser that this product will be free from defects in material
and workmanship for a period of one (1) year from the date of purchase. If this product proves
to be defective, purchaser may return same to Epitel for repair, replacement, refund, or credit at
Epitel’s option. All returns must be authorized in advance in accordance with Epitel’s Returned
Goods Policy found in its then current Price List. The warranty on the repaired or replaced unit
continues from the purchase date of the original unit. The liability of Epitel under this limited
warranty does not extend to any abuse, misuse, modification, improper storage, alteration,
further manufacture, packaging or processing of this product or repair by anyone other than a
Epitel representative. The following will also void this limited warranty:● Opening or servicing any component of the computing platform by anyone other than
Epitel authorized service personnel.
● Removing system labels by anyone other than service personnel authorized by Epitel.
● Connecting the computing platform to any AC adapter other than the system adapter
provided.
● Connecting the computing platform to any unauthorized accessory.
● Installing unauthorized software.
● Modification of system software without authorization by Epitel.
THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES,WHETHER EXPRESS OR IMPLIED, (INCLUDING, BUT NOT LIMITED TO, ANY IMPLIEDWARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). THE
LIABILITY AND REMEDY STATED IN THIS LIMITED PRODUCT WARRANTY WILL BE THE
SOLE LIABILITY OF EPITEL AND REMEDY AVAILABLE TO PURCHASER FOR THISPRODUCT, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR
OTHERWISE, AND EPITEL WILL NOT BE LIABLE TO PURCHASERS FOR ANY INDIRECT,
SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES ARISING OUT OF ITS
HANDLING OR USE. Some states/countries do not allow an exclusion of implied warranties,
incidental or consequential damages. You may be entitled to additional remedies under the lawsof your state/country.

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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 any of thefollowing:
Phone: (801) 497-6297
Email: support@epitel.com
Website: www.epitel.com

Epitel and REMI are trademarks of Epitel, Inc. All other trademarks are the property of theirrespective owners.
For Patent information, visit www.epitel.com/patents.
Copyright © January 2024. All other trademarks are the property of their respective owners. No
part of this document may be reproduced by any means without the prior written permission ofEpitel, Inc.
LB-0019 Rev 4

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