REMI Remote EEG Monitoring System

1Symbols Glossary
SymbolSymbol Title

Type BF appliedpart

Explanatory Text
The equipment provides
protection against electricalshock and electrical current
leakage. Applied parts are
considered to be the REMI
Sensors with adhered Stickers.

Standard Title

IEC 60417
Reference no. 5333

Graphical Symbols for
Use on Equipment

Catalog number

Indicates the manufacturer's
catalog number so that the
medical device can be
identified.

Batch code

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

Use-by date

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

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

Consult
instructions foruse

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

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

Temperature limit

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

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

FederalCommunications
Commission

FCC ID

Standard Reference

FederalCommunications
Commission
IDentification

Indicates the device has beentested to comply with FCC
standards and has been
approved.
A unique identifier assigned toa device registered with theUnited States Federal
Communications Commission

REMI Remote EEG Monitoring System

2

ISO 15223-1: 2021
Reference no. 5.1.6.
(ISO 7000-2493)

ISO 15223-1: 2021
Reference no. 5.3.8.
(ISO 7000-2620)
CFR Title 47
Chapter I
Subchapter A
Part 15
CFR Title 47
Chapter I
Subchapter A
Part 15

Medical devices —Symbols to be usedwith information to besupplied by the
manufacturer - Part 1:
General requirements
Medical devices —Symbols to be usedwith information to besupplied by the
manufacturer - Part 1:
General requirements
Medical devices —Symbols to be usedwith information to besupplied by the
manufacturer - Part 1:
General requirements
Medical devices —Symbols to be usedwith information to besupplied by the
manufacturer - Part 1:
General requirements
Medical devices —Symbols to be usedwith information to besupplied by the
manufacturer - Part 1:
General requirements
Medical devices —Symbols to be usedwith information to besupplied by the
manufacturer - Part 1:
General requirements
Radio Frequency
Devices

Radio Frequency
DevicesSymbolSymbol Title

Do not re-use

IPX3

Explanatory Text
Indicates a medical device thatis intended for one single use
only
NOTE: Synonyms for “Do notreuse” are “single use” and“use only once”.

Standard Reference
ISO/DIS 152231:2021
Reference no. 5.7.7

Standard Title
Medical devices —Symbols to be usedwith information to besupplied by the
manufacturer - Part 1:
General requirements
Degrees of protection
provided byenclosures (IP Code)Standard Practice forMarking Medical
Devices and otherItems for safety in the
Magnetic Resonance
Environment

Protected against
spraying water

Protected against spraying
water up to a 60 degree angle.

IEC 60529

MR unsafe

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

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

CautionTo indicate that caution isnecessary when operating thedevice or control close to where
the symbol is placed, or to
ISO 15223-1: 2021
indicate that the current
Reference no. 5.4.4.
situation needs operator(ISO 7000-0434A)
awareness or operator action inorder to avoid undesirable
consequences.

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

Sensoridentification
numberIndicates the identification
number of the Sensor.

N/A

N/A

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

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

Non-sterile

Indicates a medical device thathas not been subjected to asterilization process.

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)

REMI Remote EEG Monitoring System

3

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

Symbol

Rx ONLY

Symbol Title

Explanatory Text

Unique device
identifier

Indicates a carrier that contains ISO15223-1: 2021
unique device identifier
Reference no.
information.
5.7.10Date ofmanufacture

Indicates the date when the
medical device was
manufactured.

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

Prescription use
only

Caution: Federal law (USA)restricts this device to sale byor on the order of a physician.

N/A

REMI Remote EEG Monitoring System

Standard Reference

4Standard Title
Medical devices —Symbols to be usedwith information to besupplied by the
manufacturer - Part 1:
General requirements
Medical devices —Symbols to be usedwith information to besupplied by the
manufacturer - Part 1:
General requirements
N/ATable of Contents
Symbols Glossary

2

Table of Contents

5

Safety Information

7

Acronyms and Abbreviations

7

Device Description

7

Indications for Use

7

Contraindications

8

Explanation of Signal Word Consequences

8

Warnings

8

Precautions

8

Adverse Reactions

9

Operator Profile

9

Product Identifiers

9

REMI Tablet Operation

9

Session Initialization

10Enter Patient Information

11

REMI Sensor Initialization

13

Retrieve Four REMI Sensors

13

Scan REMI Sensor Barcodes

14

Acquiring The Barcode

14

REMI Sensor Replacement

15

REMI Sensor Initialization

16

Applying a Sticker to REMI Sensor

17

Applying REMI Sensor to the Scalp

18

Locating the REMI Sensor in REMI-Mobile

18

Restart Placement

19

Testing Sensor After Placement and Activation

20

Sensor Sync

21

Session Verification

22

Identify Sensor

23

Change Sensor Placement Location

23

Replace Sensor

24

REMI Remote EEG Monitoring System

5Restart Session

24

Active Recording

25

End Recording

26

End Session

28

Sensor & Sticker Disposal

28

REMI-Mobile Warning Alerts

29

Sensor Disconnect – During Active Recording

29

Sensor Disconnect – Prior to Active Recording

30

Multiple Sensors Activated31

REMI-Cloud Server Error

33

Poor Electrode Contact

34

Tablet Battery Low

35

Tablet Bluetooth Error

36

Settings

37

Accessing Session Diagnostic Information for Customer Support

38

Persyst™ Mobile for EEG Review

39

Troubleshooting

41

EMC Compliance43

FCC Intentional Radiator Certification

43

Wireless Communication

43

Cybersecurity

44

Server Maintenance

44

REMI Tablet Service and Repair

45

REMI-Mobile Upgrades

45

Sensor Specifications

45

REMI-Mobile Software Updates

45

Product Cleaning

45

Product Returns

46

Appendix A – Electromagnetic Emissions Declarations

47

Appendix B – Electromagnetic Immunity Declarations

48

Appendix C – Recommended Separation Distances

50

Appendix D – REMI Sensor Specifications and LED Indications

51

Appendix E – Warranty

52

REMI Remote EEG Monitoring System

6

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

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

Electroencephalography
Single-channel disposable EEG sensor
Conductive-adhesive sticker accessory used with REMI Sensors
Remote EEG Monitoring System
The mobile device Android™ application running on the REMI Tablet
The tablet hardware running REMI-Mobile 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 EEG are sent to the REMI Tablet running the REMI-Mobile software application.
REMI-Mobile combines the EEG from four Sensors with patient information and relays the data
to REMI-Cloud server running Persyst Server software. The EEG data is accessible through the
Persyst Mobile interface.
IMPORTANT: Note that Persyst Mobile active trends such as Spectrograms or Amplitude
Integrated EEG are not available with REMI as REMI is strictly for remote raw EEG data review.
The user interface for the REMI Tablet is a 10” LCD touchscreen display. The user interface for
REMI Sensors is a single button keypad within each Sensor. REMI Tablet power is through an
A/C adapter as well as limited onboard rechargeable battery. Sensor power is through a singleuse primary coin cell. Using its wireless link, the Sensors can exchange EEG data andcommands with the REMI-Mobile application running on the REMI Tablet.
REMI Sensors attach to the patient’s scalp via a conductive-adhesive sticker accessory. This
Sticker is made of a medical acrylic and foam adhesive with conductive hydrogel disks and has
been tested for biological safety.

Indications for Use
The REMI System is intended to be used in healthcare settings where near real-time and/or
remote EEG is warranted. REMI uses REMI disposable Sensors – a single use, single patient,disposable, wearable Sensor intended to amplify, capture, and wirelessly transmit a single
channel of electrical activity of the brain for up to 48 hours. The REMI-Mobile software and
REMI Tablet are intended to receive and transmit data from four REMI Sensors to secure cloudstorage for subsequent viewing and reviewing of EEG on third-party software.
REMI does not make any diagnosis or recommendations and is intended only as a physiologicalsignal monitor. REMI Sensors are intended for use by trained medical professionals in a
professional healthcare facility environment.
REMI Sensors are intended for use with adult and pediatric patients (6+ years). (Rx only).

REMI Remote EEG Monitoring System

7

Contraindications●●●

The REMI System should not be used on any children under the age of 6 under any
circumstances.
The REMI System should not be used on any patients who knowingly have 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 asprovided by Epitel, and only connect the power adapters to properly tested and grounded
AC outlets. Do not connect the power adapters to an AC outlet controlled by 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 four REMI
Sensors before performing a magnetic resonance imaging (MRI) scan. Do not bring any
REMI System components into an 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 and Sensors and Sticker accessories 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.
REMI Sensors and Stickers are single-patient, one-time use. Do not attempt to reuse
REMI Sensors or Stickers. Once a recording has ended all active Sensors will no longer
be able to connect to the REMI Tablet or record EEG.
Ensure that the Sticker hydrogels are aligned over the gold electrodes. Failure to do so will
result in poor data quality.
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

REMI Remote EEG Monitoring System

8

●
●
●
●

●
●
●
●

affect performance.
Do not continue to use a Sensor if it has fallen off of the scalp after a recording session
has started.
REMI Sensor wireless range is a maximum of 10m and it is recommended that the REMI
Tablet be kept within 4m of the patient to ensure a good wireless connection between the
Sensors and the REMI Tablet and to ensure EEG data is available for clinician review.
EEG data will not be transmitted by REMI Tablet or available for clinician review during thetime that the REMI Tablet is without power.
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 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 the REMI System.
Assure that the blue liner side of the Sticker is applied to the Sensor. The clear liner side of
the Sticker is intended for patient contact.

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 occur.

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. This manual
provides complete information on how to operate REMI.

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 has a uniqueserial number located on the back of the tablet. The REMI-Mobile software version number islocated in the application settings.

REMI Tablet Operation
REMI Tablet and REMI-Mobile software will initially be provisioned and configured by hospitaladministration IT department alongside Epitel™ staff. After initial provisioning, REMI Tablet and
REMI-Mobile software are ready-to-use. To operate, plug the Tablet power supply in the DC-in
jack and into a wall outlet. Press the power button until the Tablet turns on. The Tablet will takea few seconds to boot.
CAUTION: EEG data will not be transmitted by REMI Tablet or available for clinician review
during the time that the REMI Tablet is without power.
IMPORTANT: For optimal performance, the REMI Tablet is recommended to be plugged in at
all times. The REMI Tablet will operate on battery power, however, once the Tablet battery
drops below 50% capacity an alert will pop up on the REMI-Mobile application.

REMI Remote EEG Monitoring System

9Session Initialization
Once the REMI Tablet boots, it will automatically 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. Pressing the gear icon takes you to the Application Settings Screen.
IMPORTANT: Only the IT representative at your facility should change any of the application
settings. Contact your IT representative listed on the screen for help.

REMI Remote EEG Monitoring System

10Enter Patient Information
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 back to the numerickeyboard, click the “?123” button once again.
REMI Remote EEG Monitoring System11To hit Enter/Return, click the “>” button as shown in the circle below.

Enter/Return

Enter the patient’s medical record number (MRN), First Name, and Last Name in the fields.
Once patient MRN, First, and Last name fields have been entered, click the NEXT button toproceed.
IMPORTANT: The NEXT button will not appear unless all three fields are complete.

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

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REMI Sensor Initialization
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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13

Scan REMI Sensor Barcodes
Use the REMI Tablet rear camera to scan thebarcode on each of the four Sensor packages asshown below.
IMPORTANT: Only scan the barcode at bottom of packaging. The 2D barcode 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. 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 to toggle
between manual entry and barcode scanning.

REMI Sensor Replacement
If the wrong Sensor identifying information was entered, it can be replaced by clicking the blue
circle above the incorrect 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 re-enter or rescan the correct Sensor identifying information. In the example below, aSensor with the ID “B61” is being replaced.

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REMI Sensor Initialization
●
●
●

●
●
●

●

Remove the contents of each Sensor pouch.
Remove the Sensor from the pink protective covering.
Depress the center button on REMI Sensor to activate, 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 anumber of seconds for each Sensor to connect to the REMI Tablet. Bring the Sensor
close to the Tablet during this procedure.
When the Sensor connects to the REMI Tablet, the circle above that Sensor ID will fill solid
green. Additionally, the Sensor will flash its LED green 10 times.
Repeat these steps until all four Sensors have been activated. In the example below, 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 PLEASE WAIT changing to NEXT.

IMPORTANT: If there is an issue with a Sensor, it may be replaced before a recording session
begins. See instructions for replacing a REMI 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: 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.

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IMPORTANT: If it takes longer than 60 seconds for the REMI Tablet to connect to any one Sensor,
see the Troubleshooting section at end of manual.

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

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: Assure that the blue liner side of the Sticker is applied to the Sensor. The clear linerside of the Sticker is intended for patient contact.
IMPORTANT: The Stickers are one-time use and will no longer be sticky enough to properlyattach to the Sensor if it has been removed once before. If you misplace the Sticker during
alignment, peel the sticker off of the Sensor and replace with a new Sticker.

REMI Remote EEG Monitoring System

17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).

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 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 REMIMobile, 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 the 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.

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18

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. If you misplace the Sensor,
peel off the Sticker and use a new Sticker to reposition the Sensor on the scalp.
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.

REMI Remote EEG Monitoring System

19Testing Sensor After Placement and Activation
Once REMI Sensor has been placed on the scalp and connected, it is now time to test Sensor
electrode contact quality. 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 electrode contact quality (ECQ)
between the Sensor and the scalp. If the ECQ is good, the Sensor will flash its LED green
10 times; REMI-Mobile will automatically reset the TEST button to PLEASE WAIT andchange the left image to the next Placement location. If the ECQ is bad, an alert will appear.
Please see the Poor Electrode Contact Alert section. Repeat the Placement and Testing
REMI Remote EEG Monitoring System

20

procedure for the Left Forehead, Right Forehead, and Right Ear locations as instructed by
REMI-Mobile.

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 this manual.

REMI Remote EEG Monitoring System

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

●

Check to 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
Session section of this manual for details. Note, you can leave the Sensors attached to thepatient and just re-initialize and reactivate them from there.

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, click
START RECORDING to begin a recording session.
IMPORTANT: If two Sensors are in the wrong location it is possible to “swap” them in REMIMobile 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.
IMPORTANT: Once a recording session has been started, EEG and patient information will bemade available for review. It will only be possible to stop a recording and end a session after
this point. It will no longer be possible to change patient information, change the Sensor
placement, or replace the Sensor after a recording session has been started.
IMPORTANT: After 48 hours the recording will automatically end. See End Recording sectionin this manual for details.

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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 below. Click IDENTIFY. REMI-Mobile will communicate
with the Sensor to flash the LED green 10 times. The Sensor window will disappear and theSensor in the head diagram will turn solid green while the Sensor LED is flashing green. Afterthe LED flashes 10 times it will automatically stop and the Sensor in the head diagram on thedisplay will go back to solid blue.

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.

REMI Remote EEG Monitoring System

23

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 willbring 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.

REMI Remote EEG Monitoring System

24

Active Recording
Once you click START RECORDING from the Verify Session Screen, the Active Recording
Screen will appear as shown below. If there are any problems with the Sensors or withconnectivity with the REMI-Cloud platform, an alert with troubleshooting instructions will appear
during the active recording.

During an active recording session, the Sensors depicted in the REMI app will remain solid dark
blue. EEG recordings are being sent to the REMI-Cloud platform and are available for an
epileptologist to review. Clicking any individual Sensor will allow you to identify the location of
the REMI Sensor. See the Identify Sensor section of this manual. From the Active Recording
screen, it is possible to end a recording by clicking and confirming END RECORDING. See End
Recording section of this manual on how to end a recording.
IMPORTANT: After 48 hours the recording will automatically end. See End Recording sectionof this manual for details.

REMI Remote EEG Monitoring System

25

End Recording
It is possible to end a recording from the Active Recording screen as well as from some of thealert screens. To end a recording click END RECORDING. A screen will appear asking you to
confirm end recording or to cancel and go back to the previous screen, as shown below. You
may also touch anywhere on the screen to return to the previous screen. To confirm you want to
end a recording click CONFIRM.

Ending a recording will take you to one of two screens. If the REMI app does not have all of theEEG data from each REMI Sensor it will need up to five minutes to finalize the session, as
shown below. The Finalizing Session screen instructs you to remove all Sensors from thepatient and place the Sensors near the Tablet. A progress bar will indicate REMI app progress
towards finalizing the session. Once the progress bar reaches 100% the REMI app willautomatically progress to the Session Complete Screen.

REMI Remote EEG Monitoring System

26

You may also end the session immediately, although this is not recommended. To end thesession immediately, click END NOW. Ending the session immediately will automaticallyprogress to the Session Complete Screen shown below.
If the REMI app has all the EEG data from each REMI Sensor you will be automatically taken to
the Session Complete Screen shown below.
The session complete screen instructs you to dispose of Sensors and return the REMI Tablet tostorage, plugged in to the AC wall outlet. Click DONE to confirm the REMI-Mobile restart, then
OK to return to the Start Session screen.

REMI Remote EEG Monitoring System

27

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 Tablet or record EEG.
CAUTION: Do not continue to use a Sensor if it has fallen off of the scalp after a recording
session has started.
IMPORTANT: Ending a recording will permanently disable REMI Sensors. After ending arecording, the Sensors connected to the REMI Tablet will no longer be able to record or connect
to the REMI Tablet.

End Session
It is possible to end a session prior to starting a recording if there are issues such as WiFi
and/or cellular failure, Sensor Disconnection, etc. Ending a session will erase all patient
information from the REMI Tablet and reset the REMI Sensors.

Sensor & Sticker Disposal
REMI Sensors and Stickers should be disposed of at the end of a recording session or if asession is ended prematurely. Although there are no restrictions on disposing the Sensors andStickers in normal garbage, follow your medical center guidance on disposal of hospital waste.

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REMI-Mobile Warning Alerts
Sensor Disconnect – During Active Recording.

REMI Sensors may lose their wireless connection with the REMI Tablet. It is recommended tokeep the REMI Tablet as close to the patient as possible where the screen of the REMI Tablet iswithin view. If a disconnection occurs during a recording session the LED on the Sensor that is
disconnected will begin to flash alternating red and blue. An alert screen will pop up on the
REMI app to indicate which Sensor is no longer connected as shown below.
CAUTION: REMI Sensor wireless range is a maximum of 10m and it is recommended that the
REMI Tablet be kept within 4m of the patient to ensure a good BLE connection between the
Sensors and the REMI Tablet and to ensure EEG data is available for clinician review.
If the Sensor re-establishes a connection with the REMI Tablet, this alert screen willautomatically disappear. Otherwise it is possible to “snooze” the alert screen. To snooze thealert screen, set the snooze duration (up to 30 minutes) and click SNOOZE.
If the alert screen was snoozed and the Sensor is still disconnected from the REMI Tablet the
Active Recording screen will show the Sensor in red. If the Sensor re-established a connection
with the REMI Tablet during this time the Sensor will go back to blue indicating that it isrecording properly.
If after the snooze duration selected expires and the REMI Sensor has not re-established aconnection with the REMI Tablet, the alert screen will reappear. You will again be able tosnooze the alert screen by repeating this process.
The alert screen will allow you to end the recording. To end a recording click END
RECORDING. See the End Recording section of this manual.

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29

Sensor Disconnect – Prior to Active Recording

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 below. To replace the Sensor, click REPLACE SENSOR (sensor ID) andthen 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 the
REMI Tablet be kept within 4m of the patient to ensure a good BLE connection between the
Sensors and the REMI Tablet and to ensure EEG data is available for clinician review.
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.

REMI Remote EEG Monitoring System

30

Multiple Sensors Activated

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.
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31

REMI Tablet Connectivity Failure

The REMI Tablet must be connected to WiFi or cellular to function properly. Ensuring goodconnectivity with the help of medical center IT staff will ensure EEG data is available for clinician
review. Should the REMI Tablet 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 theTablet throughout the room in case the REMI Tablet loses connectivity. Should the REMI Tablet
reconnect to WiFi or cellular, the alert screen will automatically disappear.
CAUTION: EEG data will not be transmitted by REMI Tablet or available for clinician review
during the time that disconnection occurs.
IMPORTANT: You will not be able to proceed through the Initialization process until theconnectivity is re-established if the REMI Tablet loses connectivity 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.

REMI Remote EEG Monitoring System

32

REMI-Cloud Server Error

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 below, and all
REMI Sensors will begin to flash their LEDs alternating red and blue. Should the error end, thealert screen will automatically disappear.
IMPORTANT: You will not be able to proceed through the Initialization process until the REMICloud 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.

REMI Remote EEG Monitoring System

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Poor Electrode Contact

REMI-Mobile will check the electrode contact quality (ECQ) when the user clicks TEST after theplacement of each Sensor. An alert will be displayed with troubleshooting advice if a Sensor haspoor ECQ, with the option to SNOOZE or END SESSION, as shown above. SNOOZE can bechosen to close the alert, re-activate the Sensor, and then retest the Sensor.
If the Poor Electrode Contact Quality message box appears during REMI Sensor placement, it
is recommended that you replace the Sticker and reapply the Sensor in the same location on
the scalp, ensuring to place the Sensor as close to below the hairline as possible so that theclear hydrogels make good contact between the scalp and the gold electrodes on the Sensor.
If there are still issues with the Sensor ECQ after re-testing, the Sensor can be replaced byclicking 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: A Sensor can only be re-tested once. If the Sensor still has poor ECQ after thesecond test, replacing the Sensor is the only option.

REMI Remote EEG Monitoring System

34

Tablet Battery Low

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.

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Tablet Bluetooth Error

While rare, there may be times that the REMI Tablet has issues communicating with the sensor
and the Bluetooth 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 backup where it left off, after the reboot. If unresolved, it may be necessary to have IT personnel
enter the Settings screen to turn on Bluetooth connectivity.

REMI Remote EEG Monitoring System

36

Settings

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.

REMI Remote EEG Monitoring System

37

Accessing Session Diagnostic Information for Customer Support
Once active recording has begun, 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 by clicking on the title SESSION IS ACTIVE AND
RECORDING in the Active Recording Screen.
Touch the title SESSION IS ACTIVE AND
RECORDING to reveal additional REMI session
information.

Hiding the additional information can be done by clicking again on the title SESSION IS ACTIVE
AND RECORDING.

REMI Remote EEG Monitoring System

38Persyst™ Mobile for EEG Review
REMI uses FDA-cleared Persyst Server and Persyst Mobile software to provide remote viewingof EEG. Persyst Mobile works on any desktop internet browser or on mobile devices. Epitel
recommends using only desktop browsers for remote review of REMI Sensor EEG from REMI.
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 image below. Patients withactive recordings will have a green square box to the left of their name. The patient name and
MRN (ID) are displayed.

REMI Remote EEG Monitoring System

39

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.

REMI Remote EEG Monitoring System

40

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 theReplace Sensor section of this manual. 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 REMI Sensor is no longer 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 of the patient – REMI Sensors and Stickers are single-use only.
Do not attempt to reuse Sensors if they have fallen off of the patient.
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. For example, if the Tablet became
unresponsive during an active recording, it will restart, reconnect with all REMI Sensors, andcontinue recording. 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 in order torun on battery power. We recommend keeping the REMI Tablet plugged in to A/C power during
use and while in storage.
The WiFi and/or cellular connection is intermittent – It may be necessary to find a physicallocation in the room where both WiFi and/or cellular and a connection between the REMI Tablet
and REMI Sensors is reliable. We recommend that if there are WiFi and/or cellular “dead spots”
in the room that the patient be moved to a location where WiFi and/or cellular is more reliable. If
WiFi and/or cellular continues to be intermittent, contact IT.
The REMI Sensor barcode will not scan – The REMI Sensor barcode can be difficult to scanin low-light conditions, if the barcode was damaged or scratched, or if the barcode isincomplete. If the barcode is difficult to scan, we recommend manually entering the REMI
Sensor ID using the REMI Tablet touchpad keyboard. See the REMI Sensor Activation sectionof this manual. Note, once a barcode has been scanned the REMI Tablet will not allow you torescan 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
already been scanned or entered.
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
REMI Remote EEG Monitoring System

41

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. Always use a new Sticker when repositioning the Sensor on the scalp.
One or more REMI Sensors are flashing red and blue – Red and blue flashing light on the
REMI Sensors indicate that there is an alert. Check the REMI-Mobile application for an alertwith reason and status displayed. The alert on REMI-Mobile will have troubleshooting
instructions. Additional instructions may be found above and on each of the Alert sections of thismanual.

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42

EMC Compliance
The REMI System electronic components (REMI Sensor and REMI Tablet) comply with the
EMC requirements of IEC 60601-1 (see Appendices A & B). To prevent RF interference with orfrom 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
REMI Sensor FCC ID: 2AVPHEPGD1REMI Tablet FCC ID: 2AJZP-G450A1
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.
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 Tablet be kept within
4m of the patient to ensure a good wireless connection between the Sensors and the REMI
Tablet. The REMI-Mobile software will alert the user if there are disconnection issues (seeREMI-Mobile Warning Alerts section). If this occurs, bring the REMI Tablet closer to thepatient 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 REMI Tablet through the REMI-Mobile software. If a Sensor is unable to establish thisconnection during session initialization, the Sensor can be replaced (See the Replace Sensor
section of this manual).

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The REMI System uses the hospital WiFi connection and/or a cellular connection for wirelesscommunication between the REMI Tablet and the REMI-Cloud platform. Connectivity will be set
up and tested initially by the hospital administration IT department alongside Epitel staff. The
REMI-Mobile software will alert the user if there are any disconnection issues during the use 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 the 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 REMIMobile 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 hospital WiFi network and/or a cellular network. All wireless communication
settings are configured by authorized Epitel personnel and hospital administration IT
professionals during initial REMI setup and installation. These settings are password-protected
and they must not be altered by anyone outside of the hospital administration IT department. If a
problem occurs with the wireless communication between REMI-Mobile and the REMI-Cloud
platform, the REMI-Mobile software will alert the user (see REMI-Mobile Warning Alerts
section). The REMI-Mobile software is the only software authorized to be installed and run on
the REMI Tablet. Only the REMI-Mobile software is accessible by the user on the REMI
Tablet, and no attempt should be made to access and install any other software or alter any
system-level settings on the REMI Tablet.
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 theirpasswords 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 andoperate 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
REMI Remote EEG Monitoring System44

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

REMI-Mobile Upgrades
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.

Sensor Specifications
Compliance Standards
Degree of Protection
Water Ingress Protection
Operation Environment
Storage and Transport
Environment
Storage Duration

IEC-60601-1, IEC-60601-2-26, IEC-60601-1-2, IEC 60086-4, IEEE
C63.27, ISO 10993, ISTA-6, IEC 62366, IEC 62304
Type BF Applied Part (REMI Sensor)
IPX3 – Protected against spraying water up to a 60 degree angle
60°F to 80°F (16°C to 27°C), 10 to 95% relative humidity (noncondensing)
50°F to 105°F (10°C to 40°C), 10 to 95% relative humidity (noncondensing)
REMI Sensors, including their Sticker accessory, have a limited shelf-life
defined on the package labels.

REMI-Mobile Software Updates
All software updates will be installed by Epitel personnel only. Epitel will notify customers of theavailability of new software updates and make arrangements for installation of selected
upgrades.

Product Cleaning
The REMI Tablet should only be cleaned with damp cloths using water or alcohol and should
not be immersed in any liquids or gases. Cleaning of REMI Tablet should be done between
each patient use.
CAUTION: REMI Sensors and Stickers are single-patient, one-time use. Do not attempt toreuse REMI Sensors or Stickers.
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45

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
repair or maintenance needs.
Epitel Returns
465 S. 400 E. Suite 250
Salt Lake City, UT 84111
support@epitel.com
www.epitel.com

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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 in order 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 Tablet and 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 anenvironment
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.

REMI Sensor
3 Vrms150 kHz to 80
MHz
REMI Tablet
3 Vrms150 kHz to 80
MHz
Conducted RF IEC
61000-4-6

Radiated RF IEC
61000-4-3

REMI Sensor
3 V/m
80 MHz to 2.7
GHz

Recommended separation
distance:
Not applicabled = 1,2P

3 V/m
80 MHz to 2.7
GHz

d = 1,2

P 80 MHz to 800 MHz

d = 2,3GHz

P 800 MHz to 2,7where P is the maximum
output power rating of thetransmitter in watts (W)according to the transmitter
manufacturer and d is the

REMI Tablet
10 V/m80 MHz to 2.7
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Declaration – electromagnetic immunity
GHz

recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by anaelectromagnetic site survey,
should be 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 strengths 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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49

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.

REMI Remote EEG Monitoring System

50Appendix D – 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 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 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
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 REMI Tablet and/or the Troubleshooting in thismanual.

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51

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 REMI Tablet by anyone other than Epitel
authorized service personnel.
• Removing system labels by anyone other than service personnel authorized by Epitel.
• Connecting the REMI Tablet to any AC adapter other than the system adapter provided.
• Connecting the REMI Tablet 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
Website: www.epitel.com
Technical Support: support@epitel.com
Epitel and REMI are trademarks of Epitel, Inc. All other trademarks are the property of theirrespective owners.
Copyright © March 2023. 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-0001 Rev 4

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