Clinician Manual for Ambulatory Use

Clinician Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 5
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Table of Contents
Symbols Glossary

4

Safety Information
Acronyms, Abbreviations, and Definitions
Indications for Use

7
7
8

Contraindications
Operator Profile
Explanation of Signal Word Consequences
Warnings
Precautions
Adverse Reactions
REMI System Overview
Summary of Devices
Preparation Step - Initialization and Device Setup

8
8
8
9
9
10
11
11
13

Preparing REMI Tablet

13

Preparing REMI Phone

15

Installation and Setup Precautions

18

Step 1 - New Session Preparation & Initiation
Enter Patient Information

19
20

Step 2 - REMI Sensor Identification and Activation

22

REMI Sensor Identification
REMI Sensor Activation
Step 3 - Sticker Application

22
24
26

Sticker Application to REMI Sensors
Step 4 - Sensor Location Designation & Placement

26
27

REMI Sensor Placement and Orientation Best Practices

28

Sensor Synchronization

31

Step 5 - Verify Session

32

Change Placement (of sensor)

33

Identify (sensor)

33

Replace (sensor)

33

Step 6 - Handoff to Phone

35

Identify REMI Phone for Use

35

Handoff Session to REMI Phone36

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Completing Handoff and Resetting REMI Tablet

40

Best Practices for REMI Phone Connectivity to REMI Cloud41

Step 7 - Reviewing Sessions in Persyst Mobile
Accessing Persyst Mobile
Organization of Sessions within Persyst Mobile
Overview of Available Montages
Step 8 - End of Session Activities
Canceling Session on REMI Phone Before Prescribed Duration
Troubleshooting
Frequently Asked Questions
REMI Tablet General System Notifications

42
42
43
44
47
47
49
49
53

REMI Tablet Step Specific Error Messages
REMI System Maintenance and Care

57
62

Product Cleaning

62

Product Storage

62

Server Maintenance

62

REMI Tablet and REMI Phone Service and Repair

62

REMI Mobile Updates

63

Product Returns
Compliance and Certification Appendices
Appendix A - EMC ComplianceAppendix B - FCC Intentional Radiator Certification
Appendix C – FCC Radiation Exposure Statement

63
64
64
64
64

Appendix D - Technical and Security Information
Appendix E – Electromagnetic Emissions Declarations
Appendix F – Electromagnetic Immunity Declarations
Appendix G – REMI Sensor Specifications and LED Indications
Appendix H – Warranty
Legal and Regulatory Information

65
66
68
69
70
71

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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 REMI
Sensors with adhered
stickers.

Standard Title

Graphical Symbols for
Use on Equipment

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.

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

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”.

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

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.

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

Indicates the temperature
limits to which the medical
Temperature limit
device can be safely
exposedISO 15223-1: 2021
Reference no. 5.3.7.
(ISO 7000-0632)

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

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Symbol

FCC ID

IP47

Symbol Title

Explanatory Text

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

Humidity
limitation

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

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

FederalCommunications
Commission

Indicates the device has
been tested to comply with
FCC standards and has
been approved

CFR Title 47
Chapter I
Subchapter A Part
15

Radio Frequency Devices

FederalCommunications
Commission
IDentification

A unique identifier assigned
to a device registered with
the United States Federal
Communications
Commission

CFR Title 47
Chapter I
Subchapter A
Part 15

Radio Frequency Devices

Do not re-use

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

ISO/DIS 152231:2021
Reference no. 5.7.7

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

Ingress
protection

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

IEC 60529

Degrees of protection
provided by enclosures(IP Code)

MR unsafe

An item which poses
unacceptable risks to thepatient, medical staff orother persons within the
MR environment.

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

CautionTo 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.

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

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Symbol

Rx ONLY

Symbol Title

Explanatory Text

Standard Reference

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)

sensoridentification
numberIndicates the identification
number of the sensor.

N/A

Non-sterile

Indicates a medical device
that has not been
subjected to a sterilization
process.

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

Unique device
identifier

Indicates a carrier that
contains unique device
identifier information.

ISO 15223-1: 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
only

Caution: Federal law (USA)restricts this device to saleby or on the order of aphysician.

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

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

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

Acronyms, Abbreviations, and Definitions
EEG

Electroencephalography

REMI Sensor / sensor

Single-channel disposable EEG sensor

REMI Sticker / sticker

Conductive-adhesive sticker used with REMI Sensors

REMI / REMI System

Remote EEG Monitoring System

REMI Mobile

The mobile medical application that runs on qualified mobile
computing platforms.

REMI Montage

The standard order and grouping of 10 channels of EEG data
produced by REMI System

REMI Tablet / tablet

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

REMI Phone / phone

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

REMI Server

The main server of REMI Cloud that receives sensor data andgenerates REMI EEG files

REMI Server URL endpoint

The messaging service address where all messages from REMI
Mobile are provided to REMI Server

REMI Cloud

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

REMI Vigilenz™ AI for
Event Detection

Automated offline potential electrographic seizure detection
algorithm

Persyst® Mobile

Cloud-based EEG reviewing software produced by Persyst

Bluetooth® / BLE

Secure, single-device Bluetooth Low Energy protocol, used for
wireless communication between REMI Sensors and REMI Mobile
softwareClinician Manual for REMI Remote EEG Monitoring System - Ambulatory Use - Rev 5
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Indications for Use

The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where nearreal-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted.
REMI uses single use, single patient, disposable, wearable sensors intended to amplify, capture, andwirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days.
The REMI System uses the REMI Mobile software application that runs on qualified commercial
off-the-shelf mobile computing platforms. REMI Mobile displays user setup information to trained
medical professionals and provides notifications to medical professionals and ambulatory users. REMI
Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it
is stored and prepared for review on qualified EEG viewing software.
REMI does not make any diagnostic conclusion about the subject's condition and is intended as aphysiological signal monitor. REMI System is indicated for use with adult and pediatric patients (6+years).

Contraindications●●●

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

Operator Profile
REMI System can be used by trained medical professionals who wish to record
electroencephalograms as described in the Indications for Use section above.
Patients and/or Caregivers are intended to use the ambulatory components of REMI System as
described by this manual and the Patient Manual for Ambulatory Use.

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.

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Warnings●●●●

To reduce the risk of bodily injury,o Do not ingest REMI Sensors or stickers.
o Only use power adapters for REMI Tablet / REMI Phone operating platform as provided
by Epitel, and only connect the power adapters to properly tested and grounded ACoutlets. 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 in thismanual. Establish and follow a cleaning schedule.
Do not apply REMI Sticker to any surfaces other than the sensor or patient's scalp prior to use inorder to maintain proper adhesive performance.
REMI System is considered magnetic resonance (MR) unsafe. Remove all REMI Sensors before
performing a magnetic resonance imaging (MRI) scan. Do not bring any REMI Systemcomponents into a MR environment.

Precautions
●
●
●
●
●

●

●

●

●
●
●

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Avoid using REMI 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 REMI Tablet, REMI
Phone, REMI Sensors, and REMI Stickers only as instructed in this manual.
Advanced Settings on REMI Tablet should only be accessed with the assistance of trained Epitel
staff. Changes in device settings can result in delays in the initialization of a new session. To
access, contact Epitel for the Device Configuration Passcode.
Advanced Settings on REMI Phone should only be accessed with the assistance of trained Epitel
staff. Changes in device provisioning settings can result in delays in the initialization of a new
session. To access, contact Epitel for the Provisioning Passcode.
To reduce the risk of damaging REMI Sensors,o Do not immerse the sensors in a liquid or subject them to any sterilization processes.
o Do not impact, puncture, or cut them with any objects.
o Follow the sensor sticker replacement process as instructed in this manual and in thePatient Manual for Ambulatory Use.
REMI Sensors are single-patient use. Do not attempt to reuse REMI Sensors. Once a recording
has ended, all active sensors will no longer be able to connect to the computing platform orrecord EEG. Dispose of all used REMI Sensors at the end of the session.
REMI Stickers are one-time use. Do not attempt to reuse REMI Stickers after removing REMI
Sensors from the patient's scalp.
REMI Sticker placement sites should be checked daily for any adverse reactions, and replaced
as needed.
To reduce the risk of poor signal quality due to poor contact,o 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.
o Ensure that the sticker hydrogels are aligned over the gold electrodes. Failure to do sowill result in poor data quality.
o Do not place the sensor over the patient’s hair. REMI Sensor is meant to be used below
the hairline.
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●

●

●

●
●
●
●
●
●
●

●

●

To ensure a good wireless connection between REMI Sensors and the mobile devices:o REMI Tablet should be kept within 4m (13 ft) of the patient during session initialization.
o REMI Phone be kept within 4m (13 ft) of the patient while actively recording. It is
recommended to set up the charging station near patient sleeping arrangements.
EEG data will not be transmitted by the computing platform or available for clinician review
during the time that:o The computing platform is without power.
o A disconnection occurs between REMI Mobile and REMI Cloud.
o A disconnection occurs between REMI Sensors and REMI Mobile.
The radio frequency field strength generated by REMI Sensors is at a level considered safe to use
with other medical devices. However, if another device experiences electromagnetic interference
when REMI Sensors are nearby, consider moving the sensors away from that device.
REMI System, including REMI Sensors and stickers are not packaged sterile.
REMI Sensors and REMI Tablet / REMI Phone computing systems contain batteries and should
be stored in appropriate environments as described herein.
No modification is allowed of any equipment described herein. Only authorized Epitel personnel
are permitted to repair any component of REMI System.
REMI Sensor electrodes should not come into contact with any conductive parts other than
REMI Sticker.
The use of a defibrillator while wearing REMI Sensors may affect EEG recordings and REMI
Sensor functionality.
If REMI Tablet is mounted, ensure that it is securely mounted and that its size and weight do not
exceed any limitations of the surface to which it is applied.
REMI Mobile system updates require that REMI Tablet/ REMI Phone be powered on andconnected. For the fastest and most reliable updates, it is recommended to connect REMI Tablet/ REMI Phone computing system to Wi-Fi for system updates.
If a session is canceled, there will be no final file or data catchup activities. This means that any
data missing in the “In Progress” file will not be populated and the “In Progress” file will remain
incomplete.
Artifact Reduction, AR, should always remain toggled OFF when viewing REMI EEG data as thisfeature is not compatible with REMI EEG data.

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

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REMI System Overview
REMI Ambulatory system follows the same workflow for every new session. A session starts on REMI
Tablet by collecting basic patient information. REMI Sensors are activated and placed on the patient
using REMI Tablet interface for guidance. Then, REMI Tablet transfers the active session recording to
the patient facing REMI Phone. The patient is sent home with REMI Phone, REMI Sensors (alreadyplaced on their scalp), and daily sticker kits. REMI Tablet stays at the healthcare facility and is reset for
the next session.

Summary of Devices
REMI Ambulatory system consists of several components: REMI Tablet, REMI Phone, four REMI
Sensors, and REMI Stickers for sensor adhesion. REMI Tablet and REMI Phone software must bothindividually be configured to the appropriate REMI Server URL endpoint.
REMI Sensors amplify and digitize the EEG from a patient’s scalp and transmits that data to REMI
Mobile. REMI Mobile platform then uploads the data and patient information to REMI Cloud where thedata can be viewed by a clinician. After digitizing, the EEGs are wirelessly transmitted to a qualified
mobile operating platform running REMI Mobile software.
Device Communications
Each session begins with initialization and placement of the sensors by the healthcare provider using
REMI Tablet. The system then transfers the session to REMI Phone for patient use based on the
duration prescribed by the healthcare provider. During an active recording, REMI Phone relays the EEGfrom four REMI Sensors to REMI Cloud environment where the patient information and sensor EEG
data is combined into a Clinician-reviewable EEG record. REMI EEG record is accessible through
Persyst Mobile where the four REMI Sensor (eight electrodes) EEG data can be displayed in amontage of up to ten channels.

REMI Tablet Description
REMI Tablet is used for initial placement and initialization of a new REMI session. The user interface for
REMI Tablet operating platform is a touchscreen display powered by an A/C adapter and onboard
rechargeable battery. With proper cleaning and maintenance, REMI Tablet should be reused for
multiple sessions.
Each REMI Tablet has a unique serial number located on the back cover and within the application
under the Settings Menu. REMI Mobile software version can also be found in the application’s Settings
Menu. Legal & Copyright information for REMI Tablet software is accessible through the Advanced
Settings screen.
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REMI Phone Description
REMI Phone is used for ongoing recording and processing of a REMI session. The user interface for
REMI Phone operating platform is a touchscreen display powered by an A/C adapter and onboard
rechargeable battery. With proper cleaning and maintenance, REMI Phone should be reused for
multiple sessions. Each REMI Phone has a unique serial number located on their back cover andwithin the application under the Settings Menu. REMI Phone software version can also be found in theapplication’s Settings Menu. Additionally, Legal & Copyright information for REMI Phone software isaccessible through the Advanced Settings screen.
REMI Sensor Description
The user interface for REMI Sensors is a single button within each sensor. The power is through asingle-use primary coin cell battery for each sensor. Using its wireless link, the sensors can exchange
EEG data and commands with REMI Mobile application running on REMI Tablet or REMI Phone. Each
REMI Sensor has a unique serial number located on the sensor packaging.
REMI Sensors attach to the patient’s scalp via a conductive-adhesive sticker. This sticker is made of a
medical adhesive with conductive hydrogel disks and has been tested for biological safety. Eachsticker has a unique lot number located on the sticker packaging. REMI Sensors and stickers should
be disposed of after each use.
REMI Cloud Description
REMI Cloud environment is a collection of servers and storage devices where a) patient information
and REMI Sensor data is received from REMI Mobile and an EEG record is created, b) REMI Vigilenz AI
for Event Detection is called, and c) Persyst software is run allowing Clinician review of REMI EEG files.
A unique REMI Cloud environment, including a unique REMI Server URL endpoint, is configured foreach healthcare provider to ensure secure data storage.

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Preparation Step - Initialization and Device Setup
REMI Mobile software will initially be provisioned and configured on REMI Tablet / REMI Phone byhealthcare facility personnel. After initial provisioning, the computing platforms and REMI Mobile
software are ready-to-use.

Preparing REMI Tablet

To prepare REMI Tablet for operation, plug REMI Tablet into a wall outlet using the provided cable andadapter. Press and hold the power button until the tablet turns on. The tablet will take a few seconds
to boot. Once REMI Tablet boots, it will automatically display the Start Session Screen. In the upper
left-hand corner of the Start Session Screen is a “gear” icon that takes the user to the Settings Screen.
IMPORTANT: If the clock screen is shown, swipe up, which will display the Start Session Screen.
REMI Tablet must be provisioned to the appropriate REMI Server URL endpoint before beginning a
new session. Initial configuration is completed prior to arrival at the healthcare facility, but can be
confirmed by viewing the Settings screen.

REMI Tablet System Ready for Use Screen

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Advanced Settings on REMI Tablet
Advanced Settings allow users to update the provisioning of REMI Tablet and configure REMI Server
URL endpoint connection. The Advanced Settings is accessible by entering in a secure passcode to theDevice Configuration textbox.

REMI Tablet Settings Screen with Provisioning Information
CAUTION: Advanced Settings on REMI Tablet should only be accessed with the assistance of trained
Epitel staff. Changes in device settings can result in delays in the initialization of a new session. To
access, contact Epitel for the Device Configuration Passcode.

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Preparing REMI Phone

To prepare REMI Phone for operation, charge REMI Phone using the provided cable and adapter.
Press and hold the power button on the side of the device until REMI Phone turns on. Once REMI
Phone boots, it will automatically display the QR Code Screen, if it has been properly provisioned.
REMI Phone will take a few seconds to boot.

REMI Phone System Ready Screen

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REMI Phone must be provisioned to the appropriate REMI Server URL endpoint before beginning a
new session. Initial configuration is completed prior to arrival at the healthcare facility, but can be
confirmed by viewing the Settings screen.

REMI Phone Settings Screen

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Advanced Settings on REMI Phone
Advanced Settings allows users to update the provisioning of REMI Phone and configure REMI Server
URL endpoint connection. Legal & Copyright information is accessible through the Advanced Settings
screen. The Advanced Settings is listed at the bottom of the General Settings menu, but requires apasscode to access. The passcode is unique to each session.

Advanced Settings Screen on REMI Phone
CAUTION Advanced Settings on REMI Phone should only be accessed with the assistance of trained
Epitel staff. Changes in device provisioning settings can result in delays in the initialization of a new
session. To access, contact Epitel for the Provisioning Passcode.

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Installation and Setup Precautions
CAUTION: EEG data will not be transmitted by the computing platform or available for clinician review
during the time that:oooThe computing platform is without power.
A disconnection occurs between REMI Mobile and REMI Cloud.
A disconnection occurs between REMI Sensors and REMI Mobile.

CAUTION: 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 REMI Tablet /REMI Phone to Wi-Fi for system updates.
IMPORTANT: For optimal performance, REMI Tablet is recommended to be plugged in at all times.
REMI Tablet will operate on battery power, however, once the tablet battery drops below 50% capacity
a notice will pop up on REMI Mobile application.
IMPORTANT: For optimal performance, REMI Phone is recommended to be plugged in whenpossible. REMI Phone will also operate on battery power. Once REMI Phone battery drops below 25%
capacity a notice may pop up on REMI Mobile application.
IMPORTANT: To enable regular clinician review, it is recommended to keep REMI Phone powered on
and connected via Wi-Fi or cellular for at least 8 hours each day throughout a recording session.

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Step 1 - New Session Preparation & Initiation
To prepare for a new session, ensure that all of the listed materials are available. A new session begins
first with capturing patient data on REMI Tablet. When ready, press the START button on REMI Tablet
to begin a new session.
IMPORTANT: To enable reliable connection for initiation of a new session, it is recommended thatboth REMI Tablet and REMI Phone be connected to Wi-Fi to avoid interruptions or connectivity errors.
Required Materials for New REMI Session:● Four (4) REMI Sensors, REMI Stickers, and alcohol prep pads
● One (1) REMI Phone, provisioned and fully charged● One (1) REMI Tablet, provisioned and fully charged

REMI Sensors, Alcohol Prep Pads, and REMI Stickers

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Enter Patient Information

The healthcare provider should be prepared to complete all of the following fields to proceed with a
new session: patient’s medical record number (MRN), first name, last name, and prescribed monitoring
duration (in days) in the fields.
To enter patient information, touch any field to bring up the touchscreen’s alphabetic keyboard. Orderof completion does not matter here, but all fields must be completed before transitioning to the next
step.

REMI Tablet Patient Information Screen (no fields selected)

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REMI Tablet Patient Information Screen (all fields completed)
IMPORTANT: The NEXT button will not appear unless all four fields are complete.
IMPORTANT: You may restart a session at any time by clicking the counterclockwise RESTART arrowin the upper left-hand corner of the screen and confirming. See Restart Session and the End Sessionsections of this manual for further information.

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Step 2 - REMI Sensor Identification and Activation
REMI Sensors are individually packaged and programmed and can be used for only one session.
Healthcare providers must therefore identify which sensors will be included within the session. REMI
Tablet provides step-by-step instructions for this.
Additionally, REMI Sensors are stored in a sleep state. Once a healthcare provider has identified thesensor IDs for the session, they will activate the sensors through a button press to begin wirelesscommunication between REMI Sensors and REMI Tablet.

REMI Sensor Identification
Each REMI Sensor has a unique ID that can be found on the individual packaging and on theunderside of the sensor itself. REMI Tablet offers two options to capture the sensor IDs: scan thebarcode on the packages or manually enter the sensor ID using the application keyboard. REMI Tablet
will automatically move to Sensor Initialization once all four sensor IDs have been entered.

REMI Sensor ID on Individual Packaging (example)

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Scan REMI Sensor Barcodes using REMI Tablet
To scan the sensor ID, center the barcode on the screen. Once the tablet successfully reads thebarcode, a blue circle will fill and the three alpha-numeric digits of the serial number will appear ingreen text below the circle. The barcode of each sensor can only be scanned once to prevent
duplication.

REMI Tablet Sensor Identification Screen
IMPORTANT: Only scan the barcode at the bottom of packaging. The QR code in the top left is notscannable by REMI Tablet.
To manually enter the sensor ID, tap the text field and the application keyboard will appear. After
entering the sensor ID, select the enter/return arrow to save the ID and move to the next sensor. To
return to the barcode scanning, tap anywhere outside of the keyboard and text field.

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REMI Sensor Activation

To activate REMI Sensors, press the center button on the top of the sensor. Once the button has beenpressed, the sensor LED (near the four gold pins) will flash blue three times followed by green twice toindicate that the sensor is activated and broadcasting wirelessly.
IMPORTANT: The sensors activated in this step MUST match the sensors that were identified in theprevious step. Activating sensors with a different ID will not connect them with the session.
The circle above the respective sensor ID will fill green and the LED will flash green 10 times once
REMI Sensor has properly connected with REMI Tablet. Repeat with each sensor.

Sensor Connection Screen (activation in process)
IMPORTANT: If the sensor is activated and working correctly, but the circle does not fill green in REMI
Tablet, bring the sensor closer to the tablet.
IMPORTANT: If there is an issue with a sensor, it should be replaced before a recording session
begins.

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When all four sensors activate and connect to REMI Tablet, the text will change from PLEASE WAIT to
NEXT. Click the NEXT button to proceed.

Sensor Connection Screen (activation complete)
IMPORTANT: It may take a number of seconds for each sensor to connect to REMI Tablet. Clicking
sensors too quickly can sometimes cause the connection attempt between REMI Tablet and REMI
Sensor to fail. This can be avoided by waiting a few seconds 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 notconnect within 60 seconds, see the Troubleshooting section of this manual.

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Step 3 - Sticker Application
REMI Sensors require a one-piece conductive-adhesive to properly adhere to the patient’s scalp. The
adhesive stickers provided within REMI Sensor packages REMI are the only approved adhesion for
REMI Sensors.

Sticker Application to REMI Sensors

Although the stickers are double sided, the adhesives are different and order of application matters. To
apply the stickers to the sensors, remove blue liner film from the sticker. Line up the clear hydrogels
over the gold electrodes on the underside of REMI Sensors. Press smoothly around the edges toensure proper adhesion.
CAUTION: To reduce the risk of poor signal quality due to poor contact,o 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.
o Ensure that the sticker hydrogels are aligned over the gold electrodes. Failure to do sowill result in poor data quality.

Sticker Placement Screen
Once the stickers are firmly placed on the individual REMI Sensors, remove the clear film from the
sticker in preparation for placement on the patient’s scalp. Repeat for all REMI Sensors. When ready,click NEXT on REMI Tablet screen.
WARNING: Do not apply REMI Sticker to any surfaces other than the sensor or patient's scalp prior touse in order to maintain proper adhesive performance.
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Step 4 - Sensor Location Designation & Placement
REMI Sensors are not pre-programmed for a specific placement location on the patient’s scalp.
Therefore, the sensors must be identified and then assigned a location using REMI Tablet software.
Each placement will follow the same process:First, use the provided alcohol prep pads to clean the specific location. Ensure the area
is dry before placing a REMI Sensor.
Place a REMI Sensor on the patient’s scalp at the specific location according to theorientation and location details provided in REMI Sensor Placement and Orientation
Reference Guide.
Next, designate the placed REMI Sensor to that specific location by pressing its sensor
button. The screen will show a green circle when successfully completed.
Finally, test adhesion of the designated REMI Sensor to the scalp by tapping the TEST
button on REMI Tablet sensor Placement Screen. When the sensor adhesion test is
successfully completed, the sensor will flash its LED green 10 times; REMI Tablet willautomatically reset the TEST button to PLEASE WAIT and change the left image to thenext Placement location.
Repeat this process for each REMI Sensor until all four sensors have been placed. The
workflow follows the same order for designation and placement: Left Ear, Left
Forehead, Right Forehead, Right Ear.
IMPORTANT: If the sensor adhesion test is not acceptable, a notice will appear. Please see the Poor
Electrode Contact Notice section.
IMPORTANT: Once a sensor has been designated for a specific location, it will maintain thatdesignation throughout the entire duration of the session.
IMPORTANT: A REMI Sensor may be repositioned within the same location area on a patient if initialplacement is not optimal, but the sticker adhesion should be confirmed following repositioning. If the
sticker is no longer sticky enough, Step 4 - Sensor Location Designation & Placement will need tobe restarted.

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REMI Sensor Placement and Orientation Best Practices

For consistent signal output, orientation and placement of REMI Sensors is critical. For behind the ear
placements, position REMI Sensors above the mastoid and as high and close to the hairline aspossible. For forehead placements, position REMI Sensors as high on the forehead and as close to thehairline as possible.

CAUTION: To reduce the risk of poor signal quality due to poor contact, do not place the sensor overthe patient’s hair. REMI Sensor is meant to be used below the hairline.
IMPORTANT: If REMI Sensor is placed in the incorrect location, the designation can be edited later.
Make note of REMI Sensor ID and see the Change Placement section of this manual.
Place and Designate

Sensor Placement Screen: Left Ear (before sensor press)

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Sensor Placement Screen: Left Ear (after sensor press
IMPORTANT: Do not push the button on more than one REMI Sensor at this step. Activating morethan one sensor will bring up the Multiple sensors Activated error screen. If this occurs, REMI Tablet
will ask you to repeat the activation process. See additional instructions in the Multiple sensors
Activated Notice section.
IMPORTANT: If the button on REMI Sensor was pressed but the circle is not showing green in REMI
Tablet, they may be too far apart to properly communicate or the button was not pressed firmly
enough. Bring REMI Tablet closer to the patient and/or firmly press the sensor button again.
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.

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Test Adhesion

Sensor Placement Screen: Left Ear (ready for test)

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Sensor Synchronization

In order to ensure a quality recording from REMI Sensors during the active session, REMI Tablet must
synchronize the internal clocks of the sensors. No action is required by the user at this point. After
successful placement and testing of the Right Ear, REMI Tablet will transition through sensor
synchronization activities. A message box will appear to indicate that sensors are synchronizing.
IMPORTANT: The syncing message box serves as a status indicator for the synchronization process.
Selecting “Hide” will remove this indication and synchronization status will no longer be viewable.
IMPORTANT: Sensor synchronization should only take a few minutes to complete. If the process
takes longer, it is recommended to move the tablet closer to the sensors.

Sensor Synchronization In Progress

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Step 5 - Verify Session
Before beginning REMI Tablet to REMI Phone sensor handoff process, there are several verification
options within REMI Tablet to ensure that the session is ready for handoff. Review the information
presented on the sensor Verification Screen to ensure the session information is correct. This includes
reviewing the patient name and confirming sensor ID and locations are appropriately designated.

REMI Session Verify Screen (synchronization successful)Each REMI Sensor is depicted by its three-digit alpha-numeric sensor ID number. Tap the dark blue
square representing the respective REMI Sensor to access the sensor Verification Available Actions.
Users can Identify, Replace sensor, and Change Placement for any REMI Sensors. Selecting CANCELor touching outside of the message boundaries returns the application to the Verify Session Screen.
IMPORTANT: Sensor Verification Available Actions are not necessary steps to begin handoff.
IMPORTANT: If the patient name is incorrect, the only way to change this data is to completely restart
the session, which will wipe any existing information and start from the process beginning.
IMPORTANT: Selecting the CANCEL button on the screen will clear all progress to that point and wipe
any patient data. The application will reset and return the user to the Start Session Screen. Dispose of
any used REMI Sensors and stickers.

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Session Verification Screen with Sensor Verification Available Actions List

Change Placement (of sensor)
The Change Placement action is useful to redesignate a REMI Sensor location if two locations wereplaced incorrectly during the Sensor Location Designation & Placement step. Identify the incorrectly
designated REMI Sensors; refer to the Identify section to identify sensors without physically removing
them. After selecting CHANGE PLACEMENT from the sensor Verification Available Actions List, selectthe second impacted sensor. Completing this action will reorder the location of REMI Sensors on the
Verify Session Screen diagram. Note, this only needs to be done once to swap two locations.
IMPORTANT: This is the only opportunity to change the placement location of a REMI Sensor. Oncethe handoff has begun, the designation of REMI Sensor locations cannot be updated.

Identify (sensor)

The Identify action is useful in confirming physical location of a specifical REMI Sensor on the patient
without having to remove REMI Sensor from the patient’s scalp. Select the appropriate ID on the Verify
Session Screen. After selecting IDENTIFY, REMI Tablet will communicate with REMI Sensor to flash
the sensor LED green ten (10) times.

Replace (sensor)

The Replace action is useful if one or more REMI Sensors is experiencing issues. Select theappropriate ID from the available REMI Sensors. After selecting REPLACE from the sensor Verification
Available Actions List, the application returns to REMI Sensor Identification & Activation step.

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Swap Sensor Placement Confirmation Screen

Replace Sensor Confirmation Screen

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Step 6 - Handoff to Phone
REMI Phone is intended to be used by the patient once sensor Designation and Placement have been
completed on REMI Tablet. After sensor synchronization has successfully completed, REMI Tablet isready to transfer the session to the assigned REMI Phone. This transfer occurs via a “handoff” fromREMI Table to REMI Phone. Be sure to complete any necessary session verification activities, listed inthe Verify Session section, before continuing to handoff.
When ready to begin the handoff process, select the START SESSION ON PHONE button on REMI
Session Verify Screen.
IMPORTANT: Once handoff has begun, no adjustments can be made to the designation orplacements of REMI Sensors within the session.

Identify REMI Phone for Use
Each REMI Phone has a unique ID that can be found under the QR code on the Ready for Use screen.
In order to initiate the handoff, REMI Tablet must identify which REMI Phone to connect. REMI Tablet
offers two options to capture REMI Phone IDs: scan the QR Code on the phone or manually enter thephone ID using the application keyboard.

Scan Phone QR Code Screen (device identified)

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To scan REMI Phone ID, center the QR Code on the screen using the camera on the backside of REMI
Tablet. Once the tablet successfully reads the QR Code,the phone’s serial number will populate in the
text field and the CONNECT TO PHONE will become active.
To manually enter REMI Phone ID, tap the text field and the application keyboard will appear. After
entering REMI Phone ID, select the enter/return arrow to save the ID. To return to the barcode
scanning, tap anywhere outside of the keyboard and text field.

Handoff Session to REMI Phone

In order to begin the new session recording and transfer the active session to REMI Phone for patientuse, REMI Tablet must first establish a connection between the devices. Once connected, the transfer
can begin from REMI Tablet to REMI Phone.
Select CONNECT TO PHONE on the Scan phone QR Code screen to connect REMI Phone and REMI
Tablet.
IMPORTANT: Try to maintain a distance less than 4m (13 ft) between REMI Phone, REMI Tablet, and
REMI Sensors to ensure successful and timely handoff. It is recommended to minimize the distance asmuch as possible for the most efficient handoff.
Ready for Handoff

Ready for Handoff Screen (tablet)

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Ready for Handoff Screen (phone)
When ready, select HANDOFF on the Ready for Handoff Screen to initiate the transfer of the new
session to REMI Phone. During the handoff process, REMI Phone screen will provide updates on theoverall progress.
IMPORTANT: The first step is only to establish a connection between the devices. The actual session
transfer will not occur until HANDOFF has been selected on the Ready for Handoff Screen

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Transfer In ProgressTransfer In Progress Screen (tablet)

IMPORTANT: If a session needs to be canceled or ended during the Transfer Session to REMI Phone
process, select HIDE and then press the RESTART arrow in the top left corner. This action will end theactive recording and reset REMI Tablet. Dispose of the used REMI Sensors and stickers and begin theprocess anew.

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Transfer In Progress Screen (phone)
IMPORTANT: No action is required on REMI Phone during the Transfer Session to REMI Phone
process.

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Completing Handoff and Resetting REMI Tablet

After handoff is completed, the session is actively recording and using REMI Phone as the relay device
for all recorded session data. REMI Tablet is no longer necessary for the session and should be resetand cleaned for initiating future new sessions.
REMI Phone screen will update to show the In Progress Home Screen, indicating that the session is
actively recording. REMI Tablet screen will show that the handoff is complete. Press the DONE button
on REMI Tablet screen to initiate the application reset activities. Refer to the Product Cleaning section
for additional information on storage and reuse procedures.
Handoff Complete

Handoff Complete Screen (tablet)

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Session In Progress Home Screen (phone)
IMPORTANT: For information on general usability of REMI Phone during and at the end of an active
session, please refer to Patient Manual for Ambulatory Use.

Best Practices for REMI Phone Connectivity to REMI Cloud

The following list of considerations are not required for successful sessions, but are recommended
best practices to ensure optimal data transmission during an active session.
●●●

Keep REMI Phone within 3 ft of the sensors at all times
Ensure REMI Phone is charged; avoid letting the battery die during or after the active recording
Connect to strong Wi-Fi whenever possible; cellular will also transmit the data, but wirelessinternet tends to be more reliable

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Step 7 - Reviewing Sessions in Persyst Mobile
Once a session has successfully started on REMI Phone, the device will begin to capture and transmit
EEG data from REMI Sensors to REMI Cloud. REMI Phone uses a combination of real-time data
capture and short-term caching to upload new data to REMI Cloud. Once stored in REMI Cloud, theEEG data is processed and presented in Persyst Mobile.
No action is required by the patient to ensure data is transmitting, but consistent connectivity is criticalto enable near real-time monitoring of the active session. If connectivity is poor during the active
recording, the session data will appear incomplete in the Persyst Mobile file until the end of thesession.

Accessing Persyst Mobile
REMI Remote EEG Monitoring System has been qualified for use with FDA-cleared Persyst Server and
Persyst Mobile software to provide remote review of REMI EEG. Persyst Mobile works on any desktop
internet browser or on mobile devices.
A unique Persyst Mobile site is established as a part of the provided REMI Cloud environment. The
web address and individual user credentials are available via healthcare network administrator. To
access the Persyst Mobile site, log into the Persyst Mobile web address using the username andpassword provided.

Persyst Mobile Login Screen

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Organization of Sessions within Persyst Mobile
The Persyst Mobile of REMI sessions is organized by “In Progress” and “Completed” recording
headings. During an active recording, the session will appear under the “In Progress” heading thePatient Name and MRN (ID). Occasionally, a green square box will be present to the left of their nameindicating that new data is being uploaded.
Selecting the Patient Name highlights that patient and lists the beginning and the current end of thepatient recording as comments on the right side of the screen. Selecting any of the comments willbring up the patient’s EEG record, displayed in the REMI-LR 10-channel montage.

Persyst Mobile Patient Views Screen
IMPORTANT: Any EEG data missed during the ongoing active session file creation is displayed aszero-value data in the Persyst Mobile “In Progress” recordings.

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Overview of Available Montages
Two different EEG montages are initially available for reviewing a patient’s REMI EEG record (REMI-LR,
REMI-FB).
REMI-LR Montage
The default montage, REMI-LR, displays the patient’s left-sided channels in the first group, then thepatient’s right-sided channels in the second group. The third group contains the two transverse
channels and the fourth group contains the two oblique channels. REMI-LR channel grouping andorder most closely reflects the commonly used double-banana montage.

Patient EEG Record Displayed in the REMI-LR Montage

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REMI-FB Montage
An alternate montage, REMI-FB, displays the patient’s front (or anterior) channels in the first group,
then the patient’s back (or more posterior channels) in the second group. This montage places frontal
channels together and temporoparietal channels together. The third group contains the twolongitudinal channels and the fourth group contains the two oblique channels. REMI-FB montage canbe selected from the dropdown menu on the top left while viewing a patient record.

Patient EEG Record Displayed in the REMI-FB Montage
CAUTION: Artifact Reduction, AR, should always remain toggled OFF when viewing REMI EEG dataas this feature is not compatible with REMI EEG data.
IMPORTANT: Persyst Mobile offers several additional user settings and EEG settings that can be
adjusted within the EEG record, including: page duration (seconds of data per page), sensitivity (orgain), low frequency filter, high frequency filter, playing speed (pages per second), toggling minor andmajor gridlines on or off, toggling restrict pen deflection on or off, and toggling high resolution eeg onor off.
Detailed instructions on the use of Persyst Mobile, including how to edit user settings and create yourown montages, can be found in the Persyst Mobile User Guide.
https://www.persyst.com/PersystMobile/UserGuide.pdf
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Comments Available in Persyst Mobile
Persyst Mobile allows users to annotate the “In Progress” and “Completed” records to denoteelectrographic areas of interest during an active session. Additionally, it supports annotations fromREMI Remote EEG Monitoring System.

Persyst Mobile (with comments)
The following is a list of annotations that are enabled from REMI Remote EEG Monitoring System:● System Logged Annotations○ Beginning of Record○ Current End of Record● REMI Phone Logged Annotations - comments that have been created from activities on REMI
Phone
○ Sticker Change Discomfort○ Sticker Change Shower/Bath○ Sticker Change Sensor Fell Off○ Sticker Change Other○ Sticker Change○ User Logged Event○ Session Canceled● Clinician Logged Annotations - comments that have been created by the reviewing Clinician
using Persyst Mobile● REMI Vigilenz AI for Event Detection Annotations, if enabled - potential electrographic seizure
events detected○ Discrete Event Detected (Very High Confidence (95-100%))○ Discrete Event Detected (High Confidence (80-94%))○ Discrete Event Detected (Moderate Confidence (50-79%))○ Discrete Event Detected (Low Confidence (0-49%))
IMPORTANT: For additional information regarding comments resulting from REMI Vigilenz AI for Event
Detection, please refer to Reviewer Manual for REMI Vigilenz AI for Event Detection.
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Step 8 - End of Session Activities
At the conclusion of the prescribed duration of the recording, REMI Phone will automatically initiate theend of session activities. No action is required by the Patient/Caregiver or Clinician to successfullycomplete the final file generation.
Once a session has ended, it will go through a final step to catch-up and update any missing EEG
data. Additionally, REMI Vigilenz AI for Event Detection will process the final file, if enabled. For
information on Patient/Caregiver supported activities at the end of the session, please refer to Patient
Manual for Ambulatory Use. This final processing step can take up to five (5) days to complete
depending on connectivity during and at the end of the active session.
Upon completion of the final EEG data catch-up activities, reviewing Clinicians will receive an email
notification that the “Completed” record is available for review. The email contains the last fouralphanumeric digits of the MRN (ID) and start time associated with the recording to help identify thecomplete record.

New REMI Session Ready to Review Email (with REMI Vigilenz AI for Event Detection)
For additional information on end of session activities on the REMI Phone, please refer to the Patient
Manual for Ambulatory Use.

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Canceling Session on REMI Phone Before Prescribed Duration
A session can be canceled before the prescribed duration if desired. To cancel an active session,navigate to the Advanced Menu on REMI Phone. A passcode is required to access the Advanced
Menu on REMI Phone, contact Epitel for support. Once accessed, select the “Cancel Session” button
within the Advanced Settings menu. Select the checkmark to cancel the session or the x to cancel therequest. Once canceled, REMI Phone will automatically transition to the Session Complete screen.
CAUTION: If a session is canceled, there will be no final file or data catchup activities. This means thatany data missing in the “In Progress” file will not be populated and the “In Progress” file will remain
incomplete.

Advanced Settings Screen (phone)

Cancel Session Confirmation (phone)

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Troubleshooting
REMI Remote EEG Monitoring System provides error messages and system notices to support in-app
troubleshooting. For information on error messages and system notices on REMI Phone, please refer
to Patient Manual for Ambulatory Use.

Frequently Asked Questions
REMI Sensors
An active recording session will continue even if a REMI Sensor is no longer functioning properly.
However, a new session cannot begin without four (4) functioning REMI Sensors. In the case of faulty
or unresponsive sensors, the items can be returned to Epitel for replacement. See Appendix H Warranty section of this manual.
What do the different LED colors mean on REMI Sensor?
REMI Sensor has several key patterns for the LED behaviors, after a button press:● Alternating blue and red flashes - the sensor is active and broadcasting, but not yet connected
to REMI Tablet● Continuous green flashes, up to ten (10) times - the sensor is active and has successfully
connected to REMI Tablet● Continuous red flashes, up to ten (10) times - the sensor is faulty and unfit for use● Single green flash - the sensor is active and recording
What if I don’t see any flashes on a REMI Sensor after pressing the button?
Ensure you are looking towards the corner where the LED is located on REMI Sensor when pressing
the button (next to the four gold 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, the sensor is faulty and unfit
for use.
Why is a REMI Sensor continuously disconnecting from REMI Tablet?
Ensure REMI Tablet is close enough to the patient to properly connect. It is recommended to replace
REMI Sensor if the disconnection continues and a recording has not yet been started.
Why won’t a REMI Sensor connect to REMI Tablet?
If a REMI Sensor wireless radio is faulty, it will be unable to properly communicate with REMI Tablet. In
this case, the LEDs of that REMI Sensor will likely be blinking red. Replace with a new, unused REMI
Sensor.
What do I do when a REMI Sensor detaches after a sensor adhesion test has passed?
A single sticker replacement can be initiated on REMI Phone after placement has occurred. Refer tothe Patient Manual for Ambulatory Use for additional information on sticker changes.

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REMI Tablet
A new session cannot begin without an up-to-date and functioning REMI Tablet. In the case of faulty
or unresponsive REMI Tablets, first try a hard reboot of the device by pressing the power button on theside of the device and selecting “Restart”. It will take a few seconds to reboot; however, REMI Mobile
app will return to the previous screen. If the issue persists, call Epitel support for additional guidance.
Faulty items can be returned to Epitel for replacement. See Appendix H - Warranty section of thismanual.
What do I do if a sensor doesn’t activate during placement?
If REMI Sensor LED blinks red or the LED of REMI Sensor fails to engage, it is not fit for use andshould be replaced. To replace a sensor, tap and hold the circle assigned to the sensor ID. A
confirmation modal will appear to remove the selected sensor ID. Dispose of the defective sensor andrepeat REMI Sensor identification and activation steps to replace.

Sensor Scan Screen (replace sensor)
What do I do if REMI Tablet does not start?
Ensure REMI Tablet is plugged in to A/C power before trying to power it on. If not stored properly, thebattery will drain and need to recharge before powering up. Refer to Product Storage for additional
information.
What do I do if REMI Tablet isn’t scanning REMI Sensors and/or REMI Phone?
If REMI Tablet is not able to scan either REMI Sensors barcodes or the QR code on REMI Phone, it ispossible to manually enter either using the tablet’s touchpad keyboard. To manually enter the IDs, tap
the text field and the application keyboard will appear. Be sure to select the enter/return arrow to savethe ID. To return to the barcode scanning, tap anywhere outside of the keyboard and text field.
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Can I restart the REMI Sensor placement flow?
The Sensor Placement workflow can be restarted and/or reset at any time by clicking thecounter-clockwise arrow in the upper left-hand corner of the screen. Selecting CANCEL or touchingoutside of the message boundaries returns the application to the previous workflow progress.
Selecting CONFIRM, resets any existing placement workflow. Remove any previously placed sensors
from the patient’s scalp and dispose of used stickers. Refer to Step 3 - Sticker Application forassistance in replacing the stickers on REMI Sensors.

Restart Sensor Placement Confirmation Screen
REMI Phone
A new session cannot begin without an up-to-date and functioning REMI Phone. In the case of faulty
or unresponsive REMI Phones, first try a hard reboot of the device by pressing and holding the green
power button on the side of the device and selecting “Restart”. It will take a few seconds to reboot;however, REMI app will return to the previous screen. If the issue persists, call Epitel support for
additional guidance. Faulty items can be returned to Epitel for replacement. See Appendix H Warranty section of this manual.
Why won’t REMI Phone charge with my charger?
REMI Phone is not compatible with fast charging cables typically provided with personal smart
devices. Ensure that the Epitel provided charger and charging cable are being used to charge thedevice or REMI Phone may shut down even if it is plugged in.
What do I do if REMI Phone does not start?
Ensure REMI Phone is plugged in to A/C power before trying to power it on. If not stored properly, thebattery will drain and need to recharge before powering up. Refer to Product Storage for additional
information.
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What do I do if REMI Phone is not displaying a QR Code for a handoff?
If REMI Phone is not displaying the QR code as described in Step 1 - New Session Preparation &Initiation, contact Epitel for support in properly provisioning the device for use.

Provision Device Screen (phone)

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REMI Tablet General System Notifications
General System Notifications can occur at any point throughout the new session process. They
provide information that is helpful or valuable for the user, but will not impede the overall progress ifleft unresolved. Most notifications will resolve themselves without user intervention.
Low Battery

Battery Critically Low Notice

Summary:
When REMI Tablet battery reaches 50% capacity or less and is not plugged into A/C power, this notice
will appear.
Troubleshooting:
If REMI Tablet battery power is above 25% you will be able to “snooze” the notice and move forwardwith current activities. However, if the tablet Battery Low notice appears prior to start of recording OR
the battery power is below 25% power, a new session cannot begin until REMI Tablet has been
plugged into an A/C power. Connecting REMI Tablet to power will automatically dismiss the tablet
Battery Low notice.

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Connection to REMI Server is Not Available

REMI Server Not Available Notice
Summary:This notice typically appears before starting a new session. REMI Tablet must be connected to REMI
Server URL endpoint in order to begin a new session. This connection is established via a Wi-Fi
connection or cellular network. In some cases, this notice may be triggered by an issue with REMI
Cloud.
Troubleshooting:Confirm that REMI Tablet has strong connection via a Wi-Fi connection or cellular network. If the issue
persists, contact Epitel Customer Support for assistance. The notice will disappear automatically whenresolved.

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Bluetooth is Not Enabled

Bluetooth Not Enabled Notice

Summary:
There may be times that REMI Tablet has issues communicating with the sensor because the wirelessconnection is not enabled.
Troubleshooting:If this occurs, reboot REMI Tablet by pressing and holding the power button on the side of the device.
REMI Mobile application will pick back up where it left off, after the reboot. If unresolved, it may benecessary to toggle REMI Tablet’s Bluetooth off/on via REMI Tablet Advanced Settings Menu.

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Wi-Fi or Cellular Not Connected

WiFi or Cellular Not Connected Notice
Summary:This notice appears if the connection issue arises while in the process of setting up a new session.
Without an established Wi-Fi connection or cellular network, REMI Tablet will lose its connection to
REMI Server URL endpoint.
Troubleshooting:Confirm that REMI Tablet has strong connection via a Wi-Fi connection or cellular network. To update
the Wi-Fi information, select End Session and adjust the Wi-Fi connection through the Settings Menu.
The notice will disappear automatically when resolved.

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REMI Tablet Step Specific Error Messages
Step Specific Error Messages occur at specific instances in the process and will impede the overall
progress if left unresolved. Most errors can be resolved with user intervention.
Sensor in Location Has Poor Contact during Step 4 - Sensor Location Designation & Placement

Poor Contact Notice
Summary:
When placing REMI Sensor on the patient’s scalp, this error can occur if REMI Sensor does not haveappropriate contact with the skin. This notice will occur after selecting TEST if the sensor adhesion
test for that sensor is unacceptable and provides users with the option to SNOOZE or END SESSION.
Troubleshooting:Select SNOOZE to close the notice. Examine the placement of REMI Sensor in question and ensurethat REMI Sensor has good contact between the sticker and skin. REMI Sensor can be removed andrepositioned, but if the sticker has been contaminated, be sure to replace it with a new sticker. After
securing REMI Sensor, press the button and return to REMI Tablet. Select RE-TEST to reattempt thesensor adhesion test.

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Sensor in Location Has Poor Contact, Re-Test Failed, during Step 4 - Sensor Location
Designation & Placement

Poor Contact Notice

Summary:
During Step 3 - Sensor Location Designation & Placement, a REMI Sensor can re-test sensor
adhesion once. If REMI Sensor still has poor sensor adhesion after the second test, replacing thesensor is the only option.
Troubleshooting:Selecting REPLACE returns the user to Step 2 - REMI Sensor Identification & Activation. Be sure todispose of any used, faulty REMI Sensors.

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Multiple Sensors Activated during Step 4 - Sensor Location Designation & Placement

Multiple Sensors Activated Notice
Summary:
The Multiple Sensors Activated Notice will appear when more than one REMI Sensor has been
activated during the sensor Location Designation & Placement Steps. This error occurs when REMI
Tablet has competing sensors for the current designation. Only one REMI Sensor can be placed ateach location and REMI Tablet sends the designation of that location during each individual sensor
placement process.
Troubleshooting:
To resolve this issue, REMI Tablet will automatically “inactivate” the competing sensors and prompt a
repeat in the designation and placement. Select SNOOZE and repeat the steps for the most recent
placement. Note, if a REMI Sensor is already on the patient’s scalp in the location shown, press thecenter button again on that sensor to activate.

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Sensor Disconnect during Step 5 - Verify Session

Sensor Disconnected Notice

Summary:
A REMI Sensor may disconnect from REMI Tablet before an active recording begins. This issue
generally occurs because REMI Tablet is too far from REMI Sensor for reliable connectivity, but insome rare cases may be a result of a faulty REMI Sensor.
Troubleshooting:First, attempt to bring REMI Tablet closer to the patient. The notice will resolve automatically once it
has reestablished the connection. The options to REPLACE REMI Sensor that has disconnected or
END THE SESSION are also available if needed. To replace REMI Sensor, click REPLACE (sensor ID)
and then CONFIRM and return to Step 2 - REMI Sensor Identification & Activation. Be sure todispose of any used, faulty REMI Sensors.

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Handoff Timeout Notification (tablet) during Step 6 - Handoff to Phone

Handoff Timeout Notice

Summary:
If the handoff from REMI Tablet to REMI Phone takes longer than a few minutes, this notice willappear. This error usually occurs because REMI Tablet, REMI Phone, and REMI Sensors are too farapart to properly communicate during this step. On rare occasions, this error occurs because of anissue with REMI Phone.
Troubleshooting:First, restart REMI Phone. Once REMI Phone has returned to the handoff screen, bring the devices
closer together and then select TRY HANDOFF AGAIN. This will reattempt handoff to REMI Phone. If
the error persists, REMI Phone may be faulty. Selecting CANCEL will end the entire session and takethe user back to Step 1 - New Session Preparation & Initiation. Dispose of the used REMI Sensors
and stickers
IMPORTANT: If a session must be canceled during Step 6 - Handoff to phone, the session will alsoneed to be canceled on REMI Phone. Additional information can be found in the Cancel Session on
REMI Phone section of this document.

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REMI System Maintenance and Care
Product Cleaning

REMI Tablet and REMI Phone 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 gasses. Cleaning of REMI Tablet and
REMI Phone should be done between each patient's 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 performing a sticker exchange.
CAUTION: REMI Sensors are single-patient use. Do not attempt to reuse REMI Sensors. Once a
recording has ended, all active sensors will no longer be able to connect to the computing platform orrecord EEG. Dispose of all used REMI Sensors at the end of the session.
CAUTION: REMI Stickers are one-time use. Do not attempt to reuse REMI Stickers after removing
REMI Sensors from the patient's scalp.

Product Storage

REMI Tablet and REMI Phone should both be stored in a powered off state. It is recommended to keep
the chargers stored with the devices to avoid mixing up cables. The devices are not compatible withmost external charging cables.

Server MaintenanceTo ensure continued operation of REMI System, Epitel performs routine server maintenance on allservers within REMI Cloud according to a server maintenance plan. Under this plan, routine
maintenance will be performed up to once monthly. During routine service maintenance, a loss ofserver connectivity for a brief time (but no longer than 60 minutes) is expected. This may result in brief
loss of patient data during the outage (while the servers reboot) and/or inability to review EEG datacollected during the outage.
Once routine server maintenance is completed, connectivity between REMI Mobile and REMI Cloud
will be seamlessly restored.
In the event that critical server maintenance is required, Epitel will communicate with healthcare
providers to notify them of potential outages and to ensure that there are no negative impacts topatient care. Critical server maintenance may require additional planning to ensure that EEG
monitoring sessions are not impacted.
For any questions related to server maintenance, contact Epitel customer service.

REMI Tablet and REMI Phone Service and Repair
REMI Tablet and REMI Phone do not require any scheduled maintenance, system checks, orcalibration. For servicing information or to return a REMI Tablet or REMI Phone for repair, contact an
Epitel customer service representative.

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REMI Mobile Updates

Whenever software updates to REMI Mobile application become available (whether due tocybersecurity enhancements, feature enhancements, resolution of anomalies, etc.), Epitel will
coordinate with healthcare 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.

Product Returns

All components of 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, anti-static, padded packaging.
Epitel recommends that users keep all original packaging in case of 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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Compliance and Certification Appendices
Appendix A - EMC Compliance

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

Appendix B - FCC Intentional Radiator Certification
REMI Sensor FCC ID: 2AVPHEPGD1
This equipment contains an intentional radiator approved by the FCC under the FCC ID numbers
shown above. This device complies with Part 15 of the FCC rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesirable operation.
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.
FCC Part 15 Information to the User
This equipment has been tested and found to comply with the limits for a Class B digital device,pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and canradiate radio frequency energy and, if not set up and used in accordance with the instructions, maycause harmful interference to radio communications. However, there is no guarantee that interference
will not occur in a particular REMI session. If REMI System does cause harmful interference to otherradio or television reception, which can be determined by turning REMI System operating platform off
and on, the user is encouraged to try to correct the interference by one or more of the following
measures:●●●●

Reorient or relocate the affected receiving antenna.
Increase the separation between REMI System and the affected receiver.
Connect REMI operating platform into an outlet on a circuit different from that to which theaffected receiver is connected.
Consult Epitel support for help.

Appendix C – FCC Radiation Exposure Statement

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
This equipment is in direct contact with the body of the user under normal operating conditions. Thistransmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

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Appendix D - Technical and Security Information
Wireless Communication
REMI System uses Low Energy Radio Frequency (RF) operating at 2.45 GHz (maximum 1mW) for
wireless communication between REMI Sensors and REMI Tablet.
● REMI Tablet should be kept within 4m (13 ft) of the patient during session initialization.
● REMI Phone be kept within 4m (13 ft) of the patient while actively recording. It is recommended
to set up the charging station near patient sleeping arrangements.
REMI System uses Wi-Fi connection and/or a cellular connection for wireless communication between
REMI Mobile and REMI Cloud platform.
● All REMI Tablet wireless communication settings are configured by authorized Epitel personnel
and healthcare provider’s IT professionals during initial REMI System setup and installation.
These settings are password-protected, and they must not be altered by anyone outside of theadministrative users.
● REMI Phone communicates natively via cellular connection and can be configured by thepatient / caregiver to communicate via a Wi-Fi network.
REMI Mobile software will notify the user if there are any disconnection issues during the use of REMI
System (see REMI Tablet Step Specific Error Messages).
REMI System complies with the IEEE C63.27-2017 American National Standard for Evaluation ofWireless Coexistence standards. To prevent RF interference with or from REMI System, portable andmobile RF communications equipment should be kept away from REMI components at distances
specified in Appendix F.
Cybersecurity
REMI Sensor communicates with REMI Mobile software through secure single-device BLE protocols.
There is no patient identifying information communicated between REMI Mobile and REMI Sensors.
Once a sensor is connected to a REMI operating platform running REMI Mobile software, the sensor
firmware and connection protocol cannot be changed or altered by the user. There are no specific user
instructions for the sensor that pertain to Cybersecurity controls.
REMI Mobile software communicates with REMI Cloud using an encrypted HTTPS protocol via a Wi-Fi
network and/or a cellular network.
REMI Cloud runs on the Amazon Web Services™ (AWS) cloud platform and follows AWS bestpractices for HIPAA security and compliance, including end-point protections and limited/secured user
access. Access to patient data via Persyst Mobile running on REMI Cloud platform is password
protected. Reviewing physicians should not share their passwords with anyone. Should a reviewing
physician’s password become compromised, please notify Epitel immediately for support.

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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 Phone

Android 11 or Higher

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Appendix E – Electromagnetic Emissions Declarations
Declaration – Electromagnetic Emissions
REMI is intended for use in the electromagnetic environment specified below. The customer or the userof 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 electronic equipment may beaffected.

RF emissions CISPR 11

Class B

REMI disposable sensors are suitable foruse in all establishments, including domestic
establishments and those directly
connected to the public low-voltage 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 F – 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 testlevel

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 with synthetic material, therelative 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 atlevels characteristic of a typical location in a
typical commercial magnetic field or hospitalenvironment
Portable and mobile RF communications
equipment should be used no closer to any partof REMI, including cables, than the recommended
separation distance calculated from the equation
applicable to the 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

d = 1,2

P 80 MHz to 800 MHz

d = 2,3

P 800 MHz to 2,7 GHz

80 MHz to 2.7 GHz

where P is the maximum output power rating of
the transmitter in watts (W) according to thetransmitter manufacturer and d is therecommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, ashould be less than the compliance level in eachfrequency range, b Interference may occur in thevicinity of equipment marked with the following
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 is affected by absorption and reflection fromstructures, 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 theelectromagnetic 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 RF compliance 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 G – REMI Sensor Specifications and LED Indications
General Specifications
Physical Size:
Weight:Power Source:
Communication Interface:
User Interface:

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

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
Hard gold electrode

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

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 and greater.
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), relative humidity above 10% (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 REMI Stickers, have a limited shelf-life defined on the
package labels.
REMI Sensors are capable of collecting and transmitting data for a minimumof 48 hours.

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Appendix H – Warranty
Epitel warrants to the original purchaser that this product will be free from defects in material andworkmanship for a period of one (1) year from the date of purchase. If this product proves to be
defective, the purchaser may return equipment 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 fromthe 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 orprocessing 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 IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). THE LIABILITY AND REMEDYSTATED IN THIS LIMITED PRODUCT WARRANTY WILL BE THE SOLE LIABILITY OF EPITEL AND
REMEDY AVAILABLE TO PURCHASER FOR THIS PRODUCT, 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 IMPLIEDWARRANTS, INCIDENTAL OR CONSEQUENTIAL DAMAGES. YOU MAY BE ENTITLED TO
ADDITIONAL REMEDIES UNDER THE LAWS OF YOUR STATE/COUNTRY.

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Legal and Regulatory Information
This document was, as far as possible, accurate at the time of release, though subsequent changes
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 the following:
Phone: (801) 497-6297
Email: support@epitel.com
Website: www.epitel.com

For Patent information, visit www.epitel.com/patents.
Copyright © July 2024 Epitel, Inc. All rights reserved. Epitel, REMI, and REMI Vigilenz are trademarksof Epitel, Inc. All other trademarks are the property of their respective owners. No part of thisdocument may be reproduced by any means without the prior written permission of Epitel, Inc.
LB-0019 Rev 5 Rel: 07/2024

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