THERANICA Nerivio User manual

Nerivio
A wireless non-invasive neuromodulation
device for the acute treatment of migraine
USER MANUAL
™

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© 2018 Theranica Bio-Electronics LTD. (“Theranica”), all rights reserved. The manual or
any of its parts should not be reproduced without the written permission of Theranica.
Theranica reserves the right to change or improve its products and accompanying
technical literature without specific notice.
Manufacturer:
Theranica Bio-Electronics LTD.
4 Ha-Omanut St.,
Netanya 4250438, Israel
Tel: [phone], Fax: [phone]
Web: www.theranica.com
2AOH8-NM

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Table of content
1. Introduction 4
1.1. About this manual 4
1.2. Product overview 4
1.3. Product functions 5
1.4. Package content 5
2. Glossary 5
3. Labels and symbols 6
4. Safety 8
4.1. Conditions for use 8
4.2. Warnings, precautions and Adverse Events 8
5. What does the treatment feel like? 11
6. Using the device 11
6.1. Starting for the first time 11
6.2. Treating a migraine Headache 17
6.3. Storing the device for next use 24
6.4. Reviewing your migraine diary 25
7. Cleaning, maintenance and disposal 25
7.1. Cleaning and maintenance 25
7.2. Disposal 26
8. Troubleshooting 26
8.1. General 26
8.2. Main errors and messages 27
8.3. LED status 28
8.4. Customer support 28
9. Operation specification 29
9.1. Environment operating conditions 29
9.2. Environmental storage and transportation conditions between uses 29
9.3. Environmental trasnportation and storage conditions 29
9.4. Electrical properties 29
10. Technical specifications 30
11. Smartphone requirements 32
12.Potential adverse reactions 32
13. Classification 32
14. EMC statement 32
14.1. Electromagnetic test result summary 33
14.2. Electromagnetic emissions 34
14.3. Electromagnetic immunity 34
14.4. Recommended separation distances 36
15. FCC radio frequency interference statement 37
16. Applicable standards 37

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1. INTRODUCTION
1.1. ABOUT THIS MANUAL
This manual provides the information necessary for the user to effectively use the
Nerivio™device.
•Do not attempt to perform any procedure before carefully reading all instructions.
•Always follow product labeling and the manufacturer recommendations.
•For any inquiry, please contact customer support at su[email protected].
1.2. PRODUCT OVERVIEW
Nerivio™is a wearable, battery-powered medical device for the acute treatment of
migraine with or without aura in patients 18 years of age or older who do not have chronic
migraine. Nerivio™is controlled by a mobile application. The Nerivio™ is intended for self-
administration at a home environment.
The device is worn on the upper arm and transmits transcutaneous electrical nerve
stimulation by applying weak electrical pulses that invoke conditioned pain modulation
(CPM) to inhibit migraine pain. Nerivio™is intended for self-administration at the onset of
a migraine episode.
The Nerivio™system includes several main components:
1. The Nerivio™device. The device is placed on the arm and produces electrical
signals. The device is good for 12 treatments of 45 minutes.
2. Armband and an extension. The armband should be wrapped around the
device on the arm to improve the contact between the device and the skin, to
secure its location on the arm and to conceal the device to enable a discreet
treatment.
3. Software application (app)
4. Travel bag
The external side of the Nerivio™device includes a power button and a LED indicator that
signals various modes of operation. The internal side includes the electrodes that deliver
neurostimulation signals. The armband secures the device in its location.
The device is controlled by an application which is installed on a smartphone. The
application controls the device, retrieves operational records from the device and stores
the data for further retrospective processing/reviewing.
The application enables the user to activate the stimulation, control the stimulation
intensity, monitor the treatment duration and pause or stop the stimulation. The application
also provides notifications and indications on the connection status and on the remaining
number of treatments. It also offers a migraine dairy feature which enables to track
information about your migraine attacks. The migraine diary can also be accessed via the
web.

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1.3. PRODUCT FUNCTIONS
•The device is battery-powered; the battery is internal, integrated, and non-
rechargeable.
•The device includes integrated electrodes, providing the electrical stimulation to the
skin.
•The device is activated by a power button.
•Armband which should be wrapped around the device on the arm to improve the
contact between the device and the skin, to secure its location on the arm and to
conceal the device to enable a discreet treatment. An extension is also provided for
larger arm sizes.
•An application (app) installed on a smartphone to control and monitor the treatment
(as well as provide other features).
1.4. PACKAGE CONTENT
•1 Nerivio™device
•1 Armband
•1 Armband extension
•1 Travel bag
•1 QuickStart guide
2. GLOSSARY
App: Mobile application running on smartphone
LED: Light-Emitting Diode
EMC: Electromagnetic compatibility
TENS: Transcutaneous electrical nerve stimulation
FDA: The Food and Drug Administration
FCC: The Federal Communications Commission

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3. LABELS AND SYMBOLS
Symbol
Description
Read and fully understand user manual before using this device
Compliance with FCC Federal Communications Commission Class B –certified for
home use
FCC identifier: 2AOH8-NM
Manufacturer
Type BF applied part (IEC60601-1)
Catalog number
Serial number
IP22
Ingress protection rating
Use by date - indicates the date after which the device is not to be used
Keep dry
Temperature limits

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Humidity limitation
Atmospheric pressure limitation
Caution
Keep away from sunlight
Special requirements for waste of electrical and electronic equipment (WEEE
Directive). This product must not be disposed of via municipal waste collection.
Separate collection for electrical and electronic equipment waste per Directive
2012/19/EC in the European Union is required. Contact the manufacturer for
details.
Caution: Federal (US) law restricts this device to sale by or on the order of a
physician.
Fragile, handle with care

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4. SAFETY
4.1. CONDITIONS FOR USE
4.1.1. INDICATION FOR USE
The Nerivio™is indicated for acute treatment of migraine with or without aura in patients
18 years of age or older who do not have chronic migraine. It is a prescription use, self-
administered device for use in the home environment at the onset of migraine headache
or aura.
4.1.2. CONTRAINDICATIONS
I. The device should not be used by people with congestive heart failure (CHF),
severe cardiac or cerebrovascular disease.
II. The device should not be used by people with uncontrolled epilepsy
III. The device should not be used by people with an active implantable medical
device, such as a pacemaker, hearing aid implant, or any implanted electronic
device. Such use could cause electric shock, electrical interference or serious
injuries or medical conditions.
4.2. WARNINGS, PRECAUTIONS AND ADVERSE EVENTS
The following icons are used throughout this user manual:
Warning: Indicates a potentially hazardous situation which, if not avoided, could
result in serious injury or death.
Precaution: Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury to the user or patient or damage to the
equipment or other property.
Note: indicates important information regarding the use of the system
Warnings
Do not attempt to perform any procedure before carefully reading all the
instructions
Do not use the device on the heart, chest, neck, head or any other body location
other than the upper arm, because this could cause severe muscle spasms
resulting in closure of your airway, difficulty in breathing, or adverse effects on
heart rhythm or blood pressure

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Do not use the device over skin conditions, such as open wounds or rashes, or
over swollen, red, infected or inflamed areas or skin eruptions or fragile skin on
your upper arm at the treatment location
Do not share the device with other people. The device is intended to be used by
a single person to avoid skin disease or any transmissible disease
Do not disassemble, crush, incinerate or short-circuit the battery. This could
cause a fire, injury, burns, or other hazards
Precautions
Federal Law restricts this device to sale by or on the order of a physician
The device should not be applied over areas of skin that lack normal sensation.
If one upper arm is insensitive to physical sensation, use the other upper arm
Do not use the device over or in proximity to cancerous lesions
Do not use the device on an arm with a metallic implant. In such cases, consider
using it on the other upper arm
Do not use the device simultaneously with another electrical stimulation device
Do not use the device while driving, cycling, or operating any vehicle or machinery
Do not use the device on wet skin or when bathing, showering, during exercise,
while sweating or in high humidity
Do not use the device in the presence of electronic monitoring equipment (e.g.,
cardiac monitors, ECG alarms)
Do not use the device in a magnetic resonance imaging (MRI) environment
The long-term effects of chronic use of the device are unknown
The device has not been evaluated for use in pregnant women and people less
than 18 years of age.
The safety and effectiveness of the device have not been evaluated in people
with chronic migraine
The safety and effectiveness of the device have not been evaluated for the
preventive treatment of migraine headache

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Do not use the device past expiration date
Check the device for damages. If the device is damaged return it to the
manufacturer or contact customer support
If the device was damaged, do not touch exposed electronics
Do not use the device if the electrodes become significantly dirty or damaged
Keep the device in a dry environment. Moisture may damage the device
Do not start a treatment before placing the device on your arm
In case of device malfunction, remove the device from your arm and contact
customer support
It is recommended that your smartphone willbe protected by a password (or other
security mechanism) to refrain from unwanted people to activate the device
Interference to the Bluetooth connectivity may occur in the vicinity of equipment
emitting RF (e.g. microwave, routers, Wi-Fi devices)
To minimize moisture loss, when unused, the electrodes should be covered with
the provided protective film andthe device should be stored in itsoriginal package
Do not expose the device to moisture and/or high humidity. If exposed, dry the
device as soon as possible
Before or after a treatment, rub the electrodes with your finger using a drop of
water to improve their adhesiveness
Do not clean the device with soap, alcohol, submerge in water, or scrub with
abrasive material
Do not disassemble or modify the device by yourself
Do not attempt to recharge or detach the battery
Keep the device out of the reach of infants, toddlers, children and pets
The device uses Bluetooth technology; it may therefore be interfered by other
equipment utilizing RF technology, even if the other equipment complies with
CISPR emission requirements

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The device should not be used adjacent to or stacked with other equipment and
if adjacent or stacked use is necessary, the Nerivio™ should be observed to verify
normal operation in the configuration in which it will be used
Do not use devices which generate strong electrical or electromagnetic fields,
near the Nerivio™ device. This may result in incorrect operation of the device and
create a potentially unsafe situation. In order to reduce the risk of EMinterference,
it is recommended to keep a minimum distance of 30 cm (12 inches) between the
device and other electromagnetically radiating devices. Verify correct operation
of the device in case the distance is shorter. During the immunity tests the device
operated normally
Adverse reactions
During the treatment you might experience a temporary sensation of warmth, local
tingling, numbness in the arm, pain in the arm, or redness of the skin, which should
disappear shortly after the end of the treatment.
Refer to Theranica’s website at https://theranica.com for a complete listing of
clinical data and adverse events information
5. WHAT DOES THE TREATMENT FEEL LIKE?
The device transmits electrical pulses. You may feel a strong sensation at first, but it will
typically fade to a comfortable level after a couple of seconds. You will then need to set
the treatment intensity level by increasing it to the highest level that feels strong yet
comfortable and not painful (see instructions below). If the sensation is uncomfortable or
painful, you should decrease the intensity. If you experience hand numbness and/or
muscle twitching, try changing the location of the electrodes on the arm.
6. USING THE DEVICE
6.1. STARTING FOR THE FIRST TIME
Before using the device for the first time, the Nerivio app must be installed, and the device
should be connected to the app. Make sure that Bluetooth connection on your
smartphone is enabled.

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Do not attempt to perform any procedure before carefully reading all the
instructions
6.1.1. DOWNLOADING AND INSTALLING THE APPLICATION
Step 1: Verify that your smartphone is compatible with the Nerivio app (refer to
www.theranica.com for smartphone requirements).
Step 2: Download and install the Nerivio app via Google play or App store
(depending on your operating system).
Step 3: You will be asked to create an account. Follow the app instructions. During the
sign-up process, you will need to confirm the end-user license agreement (EULA). The
EULA confirmation is only required when the app is opened for the first time. For safety
reasons, you are advised to lock your smartphone screen with a password.

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If this is the first time you are using the app, you will need to create an account in the
"Sign up" screen. If you already have anaccount, use the"Sign in" to sign into your account
When creating an account, you will need to choose a password. The password must be at
least 8 characters including at least 1 uppercase letter, at least 1 lowercase letter and at
least 1 numeric digit.
During the sign-up process, the app will send you a verification email to the email address
which you have registered with. You will need to confirm this email to continue with the
registration process.
6.1.2. CONNECTING THE DEVICE TO THE APP FOR THE FIRST TIME
Step 1: Turn on the device using the power button located at the external part of the
device. A slow flashing (mostly on) green light indicates the device is on.

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Check the device for damages. If the device is damaged return it to the
manufacturer or contact customer support
Step 2: Enable Bluetooth on your smartphone. Then, open the app and connect the
Nerivio™device to the app using the app instructions. The device and the smartphone
should be in proximity of less than 1 inch (~2.5 cm). As you begin using the app, it may
ask for permissions. Please allow these permissions so that the app works properly. You
will be notified when a connection has been established. A fast flashing green light
indicates the device is connected to the app.
Power button
LEDindicator

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Step 3: Instruction how to treat a migraine headache with Nerivio™will be presented. You
can skip it by touching “Skip”.
Step 4: Place the device in its original package or in the travel bag to store it for next use
or start a treatment following the instructions below. If the device was on for over 10
minutes when no treatment was initiated, it automatically shuts down. Turn it back on to
start a treatment.
6.1.3. THE APP SCREENS
The app includes a treatment screen, a diary screen and a more screen.
Treatment screen –This screen enables to initiate, control, monitor, pause and stop a
treatment session.

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Diary screen –This screen enables you to track and edit your treatment sessions and
migraine headaches.
More screen –This screen provides access to some of the technical aspects of the app:
View profile –Select this to view your account details
Buy Nerivio–Select this to but a Nerivio™device
Connect a new Nerivio™–select this to connect to a different Nerivio™device

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Help –This screen provides access to the Nerivio™user manual and to
instructional videos that explain how to how to treat a migraine headache with
the device.
Contact customer support –Select this to contact customer support via email
Terms & Conditions –Select this to view the terms and conditions.
About- select this to view the app version and the connected device info
Sign out settings –Select to change the automatic sign out settings
Enter special code –Select to enter a code, if applicable
Sign out- select this to sign out of your account
6.2. TREATING A MIGRAINE HEADACHE
The treatment should be performed at the onset of a migraine headache. For effective
results, you should start the treatment as soon as you feel the first symptoms of the
migraine and within the first hour (60 minutes) of the migraine symptoms onset (headache
and/or aura). The treatment duration is 45 minutes.
Before you begin, make sure the smartphone Bluetooth connection is enabled.
Do not share the device. The device is intended for a single user.
Step 1: Check the device expiration date on the label located on the protective film and
on the package.

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Do not use the device past expiration date
Step 2: Make sure that your arm skin is clean, dry and free from lotion.
Step 3: Turn on the device. A slow flashing (mostly on) green light indicates the device is
on. If the LED is still off or is solid green, please contact customer support .
Step 4: Open the app and confirm the device is connected successfully. The connection
status can be viewed in the app on the top of the treatment screen. Also verify that there
is at least one remaining treatment.

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Step 5: Carefully remove the protective film from the electrodes and save it for storing the
device and maintaining the electrode adhesiveness between uses.
Step 6: Place the device on your upper arm so that the electrodes are in contact with your
skin and the LED indicator is facing outwards. The device should be located midway
between the elbow and the shoulder. Place the device directly on the skin and not on your
shirt.
Step 7: Adjust the armband to your size. There are 4 sizes you can choose from (S, M,
L, XL). Attach the extension to the armband for L and XL sizes.
Step 8: Insert the strap to the buckle of your size.
Step 9: Wrap the armband around the device on your arm and fasten the strap. The
armband will secure the device on its location and improve the contact between the
device and your skin.

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Do not use the device on the heart, chest, neck, head or any other body location
other than the upper arm
Do not use the device over skin conditions, such as open wounds or rashes, or
over swollen, red, infected or inflamed areas or skin eruptions or fragile skin on
your upper arm at the treatment location
It is important to use the device only when positioned correctly on the arm. The
device should be located midway between the elbow and the shoulder, on the
outer side of the arm.
Step 10: To start the treatment, touch ‘Start’ in the treatment screen. The treatment has
now begun and will stop automatically after 45 minutes. A slow flashing (mostly off)
green light indicates the device is stimulating.
.
Do not start a treatment before placing the device on your arm
Do not use the device on wet skin or when bathing, showering, during exercise,
while sweating or in high humidity
Do not use the device while driving, cycling, or operating any vehicle or
machinery
Do not use the device if the electrodes become significantly dirty or damaged
If the device was damaged, do not touch exposed electronics
Do not use the device in the presence of electronic monitoring equipment (e.g.,
cardiac monitors, ECG alarms)
Keep the device in a dry environment. Moisture may damage the device
Do not use the device in a magnetic resonance imaging (MRI) environment