NEUROLIEF Relivion MG User manual

Neurolief Relivion® User Manual
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USER MANUAL
For Patients

Neurolief Relivion®MG User Manual
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IMPORTANT NOTICE
Copyright © 2021 Neurolief Ltd. All rights reserved.
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system or
translated into any language or any computer language, in any form or by any third party, without the prior
written permission of Neurolief Ltd.
Any software described in this publication is furnished under a license agreement.
All other trademarks are the property of their respective owners. Other company and brand products and
service names are trademarks or registered trademarks of their respective holders.
MANUFACTURER
Neurolief Ltd.
12 Giborei Israel
Netanya, Israel
4250412
Tel –[phone]
Email –[email protected]
US ENTITY
Neurolief Inc.
1505 West Cleveland Street, Ste 200
Tampa, FL 33606
USA
Tel: +1-888-4Relivion/888-473-5484
Email –[email protected]
RX ONLY
Federal (USA) law restricts this device to sale by or on the order of a physician or with the descriptive
designation of any other practitioner licensed by the law of the state in which he/she practices to use or order
the use of the device.
INDICATIONS FOR USE
The Relivion®MG transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine
with or without aura in patients 18 years of age or older. It is a prescription device to be self-used- at home.

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SUMMARY OF CLINICAL DATA
The safety and effectiveness of the Relivion® MG device for the treatment of migraine with and without Aura was
demonstrated in a prospective, randomized, parallel-group, sham-controlled clinical trial- the RIME study. The
study included 131 patients (109 females and 22 males) experiencing migraine attacks with or without aura.
Patients were enrolled at 12 sites in the US and Israel. Baseline demographics were consistent with the migraine
population in terms of age, gender, etc. 83% (109/131) of the participants were females. The mean age was 40.3
years (SD=12.7). The mean age of migraine onset was 18.6 (SD=8.54) years and ranged from 4 to 50. 62.6% (82/131)
of the subjects had migraine without aura, 37.4% (49/131) had migraine with aura, 26.7% (35/131) of the subjects
were using migraine preventive medication at baseline.
The primary outcome was the proportion of subjects reporting reduction of migraine headache pain (i.e. pain
relief) 2 hours after treatment initiation from severe or moderate to mild or no pain, or from mild to no pain. Pain
relief at 2 hours post-treatment was found statistically significantly higher in the active group than in the sham
group: 60% of subjects in the active group compared to 37% in the sham group met the primary endpoint (p
value=0.0180), group difference: 23%. Therefore, the study was deemed successful. Furthermore, the active arm
was superior to the sham arm for all 3 study secondary endpoints, as follows:
•Pain Freedom rate at 2 hours post-treatment initiation without use of rescue medication (46.00% vs.
11.86% for active and sham arms, respectively, p-value: <0.0001).
•Improvement in MBS 2 hours post-treatment initiation without use of rescue medication (80.56% vs.
60.00% for active and sham arms, respectively, p-value: 0.0466).
•Reduction in pain level –1-hour post-treatment initiation without use of rescue medication (-0.6 (-28.7%)
vs. -0.3 (-14.4%) for active and sham arms, respectively, p-value: 0.0121).
In addition, the active arm was superior to the sham arm in the following additional parameters:
•Complete MBS Freedom 1- and 2-hours post-treatment initiation without use of rescue medication.
•Pain Freedom at 1-hour post-treatment initiation without use of rescue medication.
•Pain and MBS Relief at 1- and 2-hours post-treatment initiation without use of rescue medication.
•Complete Symptoms Free (pain and MBS)- 1- and 2-hours post-treatment initiation without use of rescue
medication.
•Sustained 2-24 hours headache Pain Relief and Pain Free without use of rescue medication.
•Pain Relief and Pain Free consistency of response across multiple treated episodes.
With respect to safety, 21 AEs were reported in 10 subjects, 8 in the active arm (incidence: 11.94%, 8/67), and 2 in
the sham arm (incidence: 3.13% ,2/64). None of the adverse events were serious, 7 AEs were considered moderate
(4 in the active arm and 3 in the sham arm), and the other 14 were mild. 16 AEs were considered as at least possibly
related to the study device (7 in 5 subjects randomized to active arm; 9 in 2 subjects in the sham arm). All the
reported AEs were fully reversible and resolved without intervention. The nature of the observed events in the
active group were anticipated and very similar to other nerve stimulators for migraine, including adverse events
that are directly related to the neuromodulatory action of the device such as transient scalp numbness sensation,
tingling and twitching. The rate and severity of events was as anticipated and similar to other available devices.
You may ask your doctor for more information regarding the clinical study.

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USER MANUAL PURPOSE
This user manual provides the necessary instructions for safely operating the Relivion®MG in accordance with
its function and intended use. These instructions include –
•An explanation of the function of controls and indicators.
•The sequence of its operation.
•Maintenance and troubleshooting.

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SYSTEM SYMBOLS
Table 1: System Symbols
Symbol
Description
Consult instruction for use
Class II equipment
Prescription only.
Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner.
Manufacturer
Manufacturing date
Type BF applied part (front and back electrodes)
Serial number
Catalog number
Operating conditions
Keep dry
IP54
IP rating. Indicates the degree of protection.
The Relivion®MG device is protected from limited dust ingress and
from water spray from any direction.

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Symbol
Description
RF transmitter
Waste Electrical and Electronic Equipment Directive (WEEE)
Single use
Keep away from sunlight
Do not use if package is damaged
Atmosphere pressure limitation
Humidity limitation
Fragile, handle with care
European conformity
Medical device

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SAFETY INFORMATION
The following section provides important safety information that must be observed while using the Relivion®
MG device.
Contraindications
•Subjects with a metal implant or shrapnel in their head, except for dental implants, should not use the
device.
•Subjects with recent (less than three months) brain or facial trauma should not use the device.
•Subjects with skin abrasions on the forehead or occiput at the contact area of the Relivion MG should
not use the device.
•Subjects with implanted neurostimulators or any implanted metallic or electronic device in the head, a
cardiac pacemaker or an implanted or wearable defibrillator should not use the device.
Warnings
•Do not use the device while driving or in conjunction with dangerous activity during which the user must
be alert and focused (for example, while operating machinery).
•Do not use the device on any other areas apart from the head.
•Do not use the device in the bath or shower.
•Do not use the device while sleeping.
•Do not to use the device in the presence of electronic monitoring equipment (e.g., cardiac monitors,
EGC alarms) that may not operate properly when the electrical stimulation device is in use.
•Apply treatment only to intact, clean and healthy skin.
•Do not use this device in locations subject to extreme high or low temperatures or humidity. Use within
the temperature and humidity range according to the product’s specifications (see Table 6).
•Do not use a device that shows signs of mechanical damage or loose parts.
•No modification of this equipment is allowed.
•Do not interconnect the Relivion MG device with other equipment.
Precautions
•The long-term effects of chronic use of the device are unknown.
•The safety of electrical stimulation during pregnancy has not been established.
•Patients with suspected or diagnosed heart disease should follow precautions recommended by their
physicians.
•Patients with suspected or diagnosed epilepsy should follow precautions recommended by their
physicians.
•Keep the device out of reach of children. Small parts, such as the disposable pads, may be a choking
hazard for small children.
•Use this device only with Neurolief electrode pads and the Neurolief power supply and charging cable
supplied with the device. Do not use any accessories, detachable parts and materials that are not
provided by Neurolief.

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•If the device does not function as described in this the user manual, stop using it and contact customer
support.
•The Relivion®MG device is designed for use by and on a single adult person. For hygiene reasons, the
device should not be shared.
Adverse Reactions
•Unpleasant sensation during treatment.
•Scalp numbness sensation during and after treatment.
•Persistent tingling sensation after the treatment ends.
•Pain.
•Skin reaction (for example irritation, lesion, burn) beneath the electrodes. In this case, treatment should
be temporarily discontinued.
•Redness of the skin under or around the electrodes. Skin redness usually disappears within several
hours after treatment.
•Sleepiness, fatigue, or disruption in sleep patterns. Sedative effect during or after treatment.
•Dizziness during or after treatment.
•Tension-type headache after treatment.
•If adverse reactions persist, stop using the device and consult your physician.
CONVENTIONS USED IN THIS USER MANUAL
NOTE
Notes provide additional important information.
TIP
Tips indicate helpful information for using the RelivionMG.
WARNING!
Warnings indicate conditions or practices that may result in damage to the equipment or minor/moderate injury to the
patient.

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Table of Contents
1INTRODUCING REVILION® MG ............................................................................ 10
1.1 WHAT IS RELIVION MG?..................................................................................................10
1.2 THE RELIVION MG KIT.....................................................................................................11
1.3 RELIVION® MG DEVICE................................................................................................... 12
2GETTING READY .................................................................................................13
STEP 1. CHARGING THE RELIVION MG.................................................................................... 13
STEP 2. ADJUSTING THE RELIVION®MG DEVICE TO FIT YOUR HEAD ..................................... 16
STEP 3. USING THE RELIVION®MG APPLICATION................................................................... 21
3USING THE RELIVION® MG DEVICE.....................................................................30
OPERATING BUTTONS AND INDICATORS.............................................................................. 30
STEP 1. PREPARING FOR TREATMENT...................................................................................33
STEP 2. PERFORMING TREATMENT.......................................................................................38
4USING THE APPLICATION.................................................................................. 41
MIGRAINE DIARY ................................................................................................................... 41
MIGRAINE REPORT SUMMARY .............................................................................................. 42
MESSAGES........................................................................................................................... 43
MORE ................................................................................................................................... 44
5TROUBLESHOOTING AND MAINTENANCE.........................................................45
TROUBLESHOOTING ............................................................................................................ 45
CLEANING AND MAINTENANCE.............................................................................................47
DISPOSAL .............................................................................................................................47
6TECHINCAL SPECIFICATIONS ...........................................................................48
AELECTROMAGNETIC COMPATIBILITY ...............................................................50
ELECTROMAGNETIC COMPATIBILITY WARNINGS..................................................................53
BFCC COMPLIANCE..............................................................................................54
FCC COMPLIANCE STATEMENT ........................................................................................... 54

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1INTRODUCING
REVILION® MG
This chapter introduces the Relivion MG device and describes its components and its package contents.
1.1 WHAT IS RELIVION MG?
Relivion MG is a non-invasive medical device. It transfers mild electrical pulses to branches of the Trigeminal
(Supraorbital and Supratrochlear) and Occipital nerves to treat headaches.
Figure 1: Relivion MG and the Targeted Nerves
NOTE
To ensure safe and proper usage, you should review this entire user manual carefully before using the Relivion MG
device.
Contact Neurolief customer support at [email protected] or visit the Neurolief website at
http://www.Relivion.com if you have any questions.
NOTE
It is highly recommended to set up the device and complete an initial training treatment prior to your first migraine
attack.

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Relivion MG consists of a device with integrated electrodes, designed to enable activation of the targeted
nerves. The on-board electronic circuit is adapted to deliver stimulation patterns to enhance proper nerve
activation. The Relivion®MG device can be worn comfortably and adjusts to various head sizes and contours.
Each time it is worn, the six electrodes are placed over the underlying nerves. The four electrodes on the
forehead stimulate branches of the Trigeminal nerve and the two electrodes at the back of the head stimulate
the greater Occipital nerves.
The Relivion MG incorporates an on-board user interface (buttons) that enables the user to
activate/deactivate the device and adjust the treatment intensity. It provides visual and auditory indications
to indicate when the device is active/non-active and when there is a low battery.
Neurolief provides a RelivionMG mobile app that can be downloaded from the Apple/Google store to the
patient’s mobile smartphone for treatment instructions, status and migraine follow-up. Even though the
Relivion MG device can be fully operated and used without this mobile app, it is highly recommended to use it
because of its benefits, described on page 21. The Relivion MG device communicates with the RelivionMG
mobile app on the patient’s mobile smartphone via a Bluetooth link. The mobile app automatically reports
treatments performed using the Relivion MG device to the physician such as treatment schedule, intensity
and duration. The app also enables the patient to enter information describing their migraines, and how they
feel before and two hours after treatment, by answering guided questions.
1.2 THE RELIVION MG KIT
The Relivion MG kit includes the components described in Figure 2
Figure 2: Relivion MG Kit
Do not use accessories other than those provided with the Relivion MG kit.

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1.3 RELIVION® MG DEVICE
The Relivion MG device can be comfortably worn on the head during treatment. It integrates six electrodes –
four at the front of the device (forehead) and two at the back (occiput). It includes two flexible arms that go
under the hair while the device is worn. Operating buttons, light indicators and a nose bridge are located in the
front part of the device. A size adjustment mechanism is located on both sides of the device.
Figure 3: Relivion MG Device –Front View
Figure 4: Relivion MG Device –Side View
Before using the Relivion®MG for the first time, make sure to perform the following preliminary steps:

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2GETTING READY
•STEP 1. CHARGING THE RELIVION MG
•STEP 2. ADJUSTING THE RELIVION MG TO FIT YOUR
HEAD
•STEP 3. USING THE RELIVION MG APPLICATION
TIP
It is highly recommended to perform the Relivion MG initial fitting and practice treatment prior to having a migraine
attack.
STEP 1. CHARGING THE RELIVION MG
It is recommended to fully charge the Relivion MG device before first use and after each subsequent use, in
order to ensure that it is always ready when needed. It takes approximately four hours to fully charge the
battery. When the battery is low, the battery indicator light blinks yellow. After the device is fully charged, it is
typically sufficient for approximately five hours of treatment.
NOTE
Only use the power supply and charging cable supplied with the RelivionMGdevice.

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TO CHARGE THE BATTERY –
1Plug the charging cable into the power supply and insert the power supply into a wall socket.
Figure 5: Relivion® MG Charger Cable and Power Supply
2Connect the magnetic connector of the charging cable to the charging socket on the Relivion MG. The
charging socket is located on the bottom of the Relivion MG device as shown below.
Figure 6: Charging Socket Location
: Magnetic Connector Connected to the ®
NOTE
Verify that the charging socket is not wet before charging the Relivion MG.

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3Verify that the battery indicator’s yellow light is on and not blinking. The yellow light blinks when the
battery is low and is steady during charging.
Figure 7: Battery Indicator Light on the Relivion® MG device
4When the Relivion MG is fully charged, the battery indicator light turns off and the status indicator’s light
is lit steady blue. When the Relivion MG device is disconnected from the charger, it turns off.
Figure 8: Status Indicator Light on the Relivion MG
NOTE
It is not possible to use the Relivion MG while it is connected to the charger.

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STEP 2. ADJUSTING THE RELIVION®
MG DEVICE TO FIT YOUR HEAD
TO ADJUST THE RELIVION MG DEVICE TO FIT YOUR
HEAD, PERFORM THE FOLLOWING STEPS–
1Insert the electrode pads, as described below
Relivion MG comes with 13 sets of electrode pads. Each set includes six electrode pads to be placed on
top of the electrodes in the device. Each set of electrode pads is provided in a separate packet.
The packet includes four pads for the front electrodes and two pads for the back (occiput) electrodes.
The four pads for the front electrodes all have the same shape, but are inserted in different directions,
as shown below –
Figure 9: Front Electrode Pads Figure 10: Back Electrode Pads
The long oval pads are for the back electrodes, as shown above.
Each set of six electrode pads can be used for one treatment.
WARNING!
Be sure to place the pads correctly before using the Relivion MG.
NOTE
Only use the electrode pads provided by the manufacturer.

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2Adjust the arms of the Relivion® MG device so that it fits tightly
on your head and does not move
NOTE
It will take a few tries until you find the right size for your device, but this step is only required once, before using the Relivion MG
for the first time.
The size of the Relivion MG device arms is determined by the numbers located on each arm.
A. First verify that each arm size is set to size 0 (men can start from size 3)
Figure 11: Size Adjustment Scale
B. Remove all accessories from your face and your head, such as eyeglasses, hair clips, hair ties, eyebrow
piercings, thick hair product, and so on.
C. Hold the magnetic arms with your index fingers at the center of the back electrode covers. Place the
magnetic ends of the arms on the front sides of your head (slightly above your ears).
Figure 12: Placing the device arms on the sides of your head above your ears

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D. Push the RelivionMG device backwards so that the arms go underneath your hair. The magnet ends
should penetrate your hair and constantly press against your scalp.
Figure 13: Pushing the device backwards on your head
NOTE
Be sure to place the arms of the Relivion MG device under your hair.
E. If the RelivionMG size fits your head, the magnet ends should connect (you might need to apply some
pressure).
Figure 14: Magnet ends meet at the back of your head

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F. If the magnets do not connect, remove thedevice and lengthen both arms by 1 unit size. To lengthen
each arm, press the size adjustment release button and extend the arm, as shown below -
Figure 15: Extending the Device Arms
Repeat steps C to F until the magnets connect properly at the back of your head and the device is fixed
tightly on your head.
NOTE
The Relivion®MG device fits head circumference of 20”- 23¹/₂”.
Make sure the device fits comfortably and that the magnets of both arms connect at the back of your head. If not, please
contact customer support.

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G. While looking in a mirror, verify that the Relivion®MG device is positioned properly, as follows –
•The nose bridge is centered on your nose.
•The front of the device is placed as close as possible to your eyebrows without covering them.
•The arms of the Relivion MG are above your ears and not over them.
•The magnet ends rest above the bump of the occipital bone at the back of your head.
Figure 16: Proper Placement of the Relivion MG