LBL-NM-0014-HK, Version 1.0 June, 2025

Nerivio®A wireless non-invasiveneuromodulationdevice for the acuteand/or preventivetreatment of migraine

USER MANUAL

2Page|© 2018 Theranica Bio-Electronics LTD. (“Theranica”), all rights reserved. Themanual orany of its parts should not be reproduced without the written permission of Theranica. Theranica reserves the right to change or improve its products and accompanyingtechnical literature without specific notice. Manufacturer:

Theranica Bio-Electronics LTD. 4 Ha-Omanut St., Netanya 4250438, Israel

Tel: +972-72-3909-763, Fax: +972-72-3909762

Web: www.theranica.com

Authorized Representative in the EU:

CEpartner4U BV

Esdoornlaan 13, 3951 DB Maarn, The Netherlands

Tel.: +31 343 442.524, Fax: +31 343 442 162

Email: office@CEpartner4U.nl

2AOH8-NM

3Page|Table of content

1. Introduction ------------------------------------------------------------------------------------------------------------------------------------51.1. About this manual ----------------------------------------------------------------------------------------------------------51.2. Product overview -----------------------------------------------------------------------------------------------------------51.3. Product functions -----------------------------------------------------------------------------------------------------------61.4. Package content ------------------------------------------------------------------------------------------------------------62. Glossary -----------------------------------------------------------------------------------------------------------------------------------------63. Labels and symbols ----------------------------------------------------------------------------------------------------------------------- 74. Safety ------------------------------------------------------------------------------------------------------------------------------------------- 104.1. Conditions for use --------------------------------------------------------------------------------------------------------104.2. Warnings, precautions and Adverse Events -------------------------------------------------------------------105. What does the treatment feel like? ----------------------------------------------------------------------------------------------- 136. Using the device --------------------------------------------------------------------------------------------------------------------------- 146.1. Starting for the first time ----------------------------------------------------------------------------------------------- 146.2. Treating aN ACUTE migraine Headache ----------------------------------------------------------------------- 206.3. Treating FOR MIGRAINE PREVENTION ---------------------------------------------------------------------- 206.4. COMBINING ACUTE AND PREVENTATIVE TREATMENTS----------------------------------------- 206.5. Start a treatment ----------------------------------------------------------------------------------------------------------216.6. Storing the device for next use --------------------------------------------------------------------------------------267. Cleaning, maintenance and disposal --------------------------------------------------------------------------------------------277.1. Cleaning and maintenance ------------------------------------------------------------------------------------------- 277.2. Disposal----------------------------------------------------------------------------------------------------------------------278. Troubleshooting --------------------------------------------------------------------------------------------------------------------------- 288.1. General -----------------------------------------------------------------------------------------------------------------------288.2. Main errors and messages ------------------------------------------------------------------------------------------- 318.3. LED status ------------------------------------------------------------------------------------------------------------------ 318.4. Customer support -------------------------------------------------------------------------------------------------------- 329. Operation specification ---------------------------------------------------------------------------------------------------------------- 339.1. Environment operating conditions --------------------------------------------------------------------------------- 339.2. Environmental storage and transportation conditions between uses -------------------------------- 3393 Environmental trasnportation and storage conditions ------------------------------------------------------339.4. Electrical properties ----------------------------------------------------------------------------------------------------- 3310. Technical specifications ------------------------------------------------------------------------------------------------------------- 3411. Smartphone requirements ---------------------------------------------------------------------------------------------------------- 3612. cybersecurity ------------------------------------------------------------------------------------------------------------------------------3613. Potential Adverse Reactions -------------------------------------------------------------------------------------------------------3714. Classification ------------------------------------------------------------------------------------------------------------------------------3715. EMC statement--------------------------------------------------------------------------------------------------------------------------- 3715.1. Electromagnetic test result summary --------------------------------------------------------------------------- 38152 Electromagnetic emissions ----------------------------------------------------------------------------------------- 39153 Electromagnetic immunity -39

4Page|15.4. Recommended separation distances ---------------------------------------------------------------------------4116. FCC radio frequency interference statement------------------------------------------------------------------------------ 4217. Applicable standards ------------------------------------------------------------------------------------------------------------------43

5Page|1. INTRODUCTION

1.1. ABOUT THIS MANUAL

This manual provides the information necessary for the user to effectivelyusetheNerivio

® 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. 1.2. PRODUCT OVERVIEW

Nerivio is a wearable, battery-powered medical device for the acute and/or preventivetreatment of migraine with or without aura in patients 12 years of age or older. Nerivioiscontrolled by a mobile application. The Nerivio is intended for self-administrationat homehealthcare environment. The device is worn on the upper arm and transmits transcutaneous remoteelectrical

nerve stimulation by applying weak electrical pulses that invoke conditionedpainmodulation (CPM) to inhibit migraine pain. Nerivio is intended for self-administrationatthe onset of a migraine episode. The Nerivio system includes several main components:

1. The Nerivio device. The device is placed on the armand produceselectrical

signals. 2. Armband and extension. The armband should be wrapped aroundthedeviceon the arm to improve the contact between the device and the skin, tosecureits location on the arm and to conceal the device for treatment discretion. 3. Software application (app)

4. Carrying bag

The external side of the Nerivio device includes a power button and a LEDindicatorthatsignals various modes of operation. The internal side includes the electrodesthat deliverneurostimulation signals. The armband secures the device in its location. The device is controlled by an application which is installed on a smartphone. Theapplication controls the device, retrieves operational records fromthe deviceandstoresthe data for further retrospective processing/reviewing. The application enables the user to activate the stimulation, control thestimulationintensity, monitor the treatment duration and pause or stop the stimulation. Theapplication also provides notifications and indications on the connection statusandonthe remaining number of treatments. It also offers a migraine dairy feature whichenablesto track information about your migraine attacks. The device is good for 18treatmentsof45 minutes, provided average stimulation intensity is under 85%.

6Page|1.3. PRODUCT FUNCTIONS

 The device is battery-powered; the battery is internal, integrated, andnonrechargeable.  The device includes integrated electrodes, providing electrical stimulationtotheskin.  The device is activated by a power button.  Armband which should be wrapped around the device on the armtoimprovethecontact between the device and the skin, to secure its location on thearmandtoconceal the device to enable discreet treatment. An extension is alsoprovidedforlarger arm sizes.  An application (app) installed on a smartphone to control andmonitorthetreatment (as well as provide other features). 1.4. PACKAGE CONTENT

 1 Nerivio

® device in an aluminum bag

 1 Armband

 1 Armband extension

 1 Carrying bag

 1 QuickStart guide

 1 Leaflet

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

7Page|3. LABELS AND SYMBOLS

Device Labeling Template

Symbol Description

Read and fully understand user manual before using this device.

www.nerivio.com

Electronic instructions for use are available at www.nerivio.com. Compliance with FCC Federal Communications Commission Class B – certified for homeuse

FCC identifier: 2AOH8-NM

Manufacturer

YYYY-MM-DD

Country code (CC) and date of manufacture (optional)

Type BF applied part (IEC606011)

8Page|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

Humidity limitation

Atmospheric pressure limitation

Caution

Keep away from sunlight

Special requirements for waste of electrical and electronic equipment (WEEEDirective). This product must not be disposed of via municipal waste collection. Separate collection for electrical and electronic equipment waste per Directive2012/19/EC in the European Union is required. Contact the manufacturer for

details. Fragile, handle with care

Unique Device Identification. A series of numeric or alphanumeric charactersthat

allows unambiguous identification of specific devices on the market

9Page|Authorized Representative in the European Union

Medical device

The device may be used multiple times on a single patient

The device is in conformity with the applicable requirements set out in withEuropean Union Medical Device Regulation (EU) 2017/745 and other applicableUnion harmonization legislation

information about distributor

information about importer

ICASA—Tested to requirements of Independent Communications Authority of SouthAfrica

10Page|4. SAFETY

4.1. CONDITIONS FOR USE

4.1.1. INDICATION FOR USE

Nerivio is indicated for acute and/or preventive treatment of migraine with or without aurain patients 12 years of age or older. It is a self-administered device for useinthehomeenvironment at the onset of migraine headache or aura for acute treatment, or everyother day for preventive treatment. 4.1.2. CONTRAINDICATIONS

I. The device should not be used by people with uncontrolled epilepsy.

II. The device should not be used by people with an active implantable medical

device, such as a pacemaker, hearing aid implant, or any implanted electronicdevice. Such use could cause electric shock, electrical interference or seriousinjuries 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, couldresult 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 damagetotheequipment or other property. Note: indicates important information regarding the use of the systemWarnings

Do not attempt to perform any procedure before carefully readingall theinstructions

Do not use the device on the heart, chest, neck, head or any other bodylocationother than the upper arm, because this could cause severe musclespasmsresulting in closure of your airway, difficulty in breathing, or adverseeffectsonheart rhythm or blood pressure

Do not use the device over skin conditions, such as open wounds or rashes, or

11Page|over swollen, red, infected or inflamed areas or skin eruptions or fragileskinonyour upper arm at the treatment location

Do not share the device with other people. The device is intended tobeusedbya single person to avoid skin disease or any transmissible disease

Do not disassemble, crush, incinerate or short-circuit the battery. Thiscouldcause a fire, injury, burns, or other hazards

Precautions

The device has not been evaluated for use in people with congestiveheartfailure (CHF), severe cardiac or cerebrovascular disease

Federal Law restricts this device to sale by or on the order of a physicianThe 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 armDo not use the device over or in proximity to cancerous lesions

Do not use the device on an arm with a metallic implant. In suchcases,consider using it on the other upper arm

Do not use the device simultaneously with another electrical stimulationdeviceDo not use the device while driving, cycling, or operating any vehicleormachinery

Do not use the device on wet skin or when bathing, showering, duringexercise,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 peoplelessthan 12 years of age

Do not use the device past expiration date

Check the device for damage, debris, and contamination. If thedeviceisdamaged, dirty or has any debris, please do not use it, and contact the

12Page|manufacturer’s customer support

If the device was damaged, do not touch exposed electronics

Do not use the device if the electrodes become significantly dirty or damagedKeep the device under the recommended environmental conditions specifiedinuser manual to avoid any damage to the device

Do not start a treatment before placing the device on your armIn case of device malfunction, remove the device fromyour armandcontactcustomer support

It is recommended that your smartphone will be protected by a password(orother security mechanism) to refrain from unwanted people to activatethedevice

Interference to the Bluetooth connectivity may occur in the vicinity of equipmentemitting RF (e.g., microwave, routers, Wi-Fi devices)

To minimize moisture loss, when unused, the electrodes should be coveredwiththe provided protective film and the device should be stored initsoriginal

package

Do not expose the device to moisture and/or high humidity. If exposed, drythedevice as soon as possible

Before or after a treatment, rub the electrodes with your finger usingadropofwater to improve their adhesiveness

Do not clean the device with soap, alcohol, submerge in water, or scrubwithabrasive 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 interferedbyotherequipment utilizing RF technology, even if the other equipment complieswithCISPR emission requirements

The device should not be used adjacent to or stacked with other equipment and

13Page|if adjacent or stacked use is necessary, the Nerivio should be observedtoverifynormal operation in the configuration in which it will be used

Do not use devices which generate strong electrical or electromagneticfields,near the Nerivio device. This may result in incorrect operation of thedeviceandcreate a potentially unsafe situation. In order to reduce the riskof EMinterference, it is recommended to keep a minimum distance of 30cm(12inches) between the device and other electromagnetically radiatingdevices.Verify correct operation of the device in case the distance is shorter. Duringtheimmunity 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, redness of the skin or musclespasm,which should disappear shortly after the end of the treatment. Consult with your healthcare professional if these reactions persist, if themigraineheadache worsens, if an allergic reaction occurs, or if there are any other concerns. Ifaserious incident that is related to the device has occurred, please report it tothemanufacturer and the competent authority of the Member State in whichyouareestablished. Refer to Nerivio’s website at http://www.nerivio.com/science/clinical-trialsforacomplete 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 thenneedtosetthe treatment intensity level by increasing it to the highest level that feelsstrongyetcomfortable and not painful (see instructions below). If the sensation is uncomfortableorpainful, you should decrease the intensity. If you experience hand numbnessand/ormuscle twitching, try changing the location of the electrodes on the arm.

If a serious incident that is related to the device has occurred, please report it tothemanufacturer and the competent authority of the Member State in whichyouareestablished.

14Page|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, andthedevice should be connected to the app. Make sure that Bluetooth connectiononyoursmartphone is enabled. Note - Children should be guided by their parents at the first time they use thedevice. Do not attempt to perform any procedure before carefully reading all theinstructions

6.1.1. DOWNLOADING AND INSTALLING THE APPLICATIONStep 1: Verify that your smartphone is compatible with the Nerivio app ( For themostupdated smartphone requirements, please contact the LRP (Local ResponsiblePerson)listed on the packaging for assistance). Step 2: Download and install the Nerivio app via Android Store or Appstore(depending on your operating system). Android Users:

The app is now available on Huawei, OPPO, vivo, Xiaomi, and

Meizu app stores. Simply search for \" 納 瑞 維 Nerivio\" to

download,or scan the QR code via Tencent MyApp for quick

installation. Apple Users:

Search for \"納瑞維 Nerivio\" in the App Store and download it

Step 3: You will be asked to create an account. Follow the app instructions. Duringthesign-up process, you will need to confirm the end-user license agreement andprivacypolicy (EULA). The EULA confirmation is only required when the app is openedforthefirst time or when the EULA was changed. For safety reasons, you are advisedtolockyour smartphone with a password or any other means (biometric, etc.).

15Page|The app will prompt you to enter your phone number and then input the received4-digitverification code. After successful verification:  For first-time users, the system will automatically create an account.  Existing users will be logged into their registered account. Adolescents may create accounts, but the process must be initiated by an adult guardianwho first establishes their own account following the above procedure. 6.1.2. CONNECTING THE DEVICE TO THE APP FOR THE FIRSTTIMEStep 1: Turn on the device using the power button located at the external part of thedevice. A slow flashing (mostly on) green light indicates the device is on.

16Page|Check the device for damages. If the device is damaged return it to themanufacturer or contact customer support

Step 2: Enable Bluetooth on your smartphone. Then, open the app andconnect theNerivio device to the app using the app instructions. The device and thesmartphoneshould be in proximity of 1 inch (~2.5 cm) or less. It is recommended not toplacethedevice on the arm during the first connection to ensure the close proximity tothephone.As you begin using the app, it may ask for permissions. Please allowthesepermissionsso that the app works properly. You will be notified when a connectionhasbeenestablished. A fast-flashing green light indicates the device is connected to theapp. Note that each device can only be associated with one user.

Step 3: Instruction how to treat a migraine headache with Nerivio will be presented. Youcan skip it by touching “Skip” or “Continue”

17Page|Step 4: Place the device in its original package or in the travel bag to storeit for next useor start a treatment following the instructions below. If the device was onfor over10minutes when no treatment was initiated, it automatically shuts down. Turnit backontostart a treatment. 6.1.3. THE APP SCREENS

The app includes a treatment screen (home screen), and a Account screen. Treatment screen – This screen enables to initiate, control, monitor, pauseandstopatreatment session.

The treatment interface also provides a customer support contact option, whichappearsafter all treatment sessions are used up

18Page|Account screen

19Page|The available options are:  View Profile: Select this option to view or edit your account details andlogout. How to Use

 FAQs

 PICS

 User Agreement  About Us.

20Page|6.2. TREATING AN ACUTE MIGRAINE HEADACHE

The treatment should be performed at the onset of a migraine headache. For effectiveresults, you should start the treatment as soon as you feel the first symptomsof themigraine and within the first hour (60 minutes) of the migraine symptomsonset(headache and/or aura). The treatment duration is 45 minutes. 6.3. TREATING FOR MIGRAINE PREVENTION

For migraine prevention therapy, the treatment should be performed every other day, regardless of your migraine status (e.g., whether you have a migraine or not onthedayof the treatment). Treatments can be performed at any time during the day; the most important thingistopick a time that is convenient for you and stick to it. The Nerivio app offerstreatmentreminders, so you never miss a treatment. 6.4. COMBINING ACUTE AND PREVENTATIVE TREATMENTS

Nerivio can be used to prevent migraines and treat migraine attacks as follows: useNerivio every other day to prevent migraine and as needed to treat every migraine. For example, if you choose to perform a preventative treatment everyMonday,Wednesday, Friday, and Saturday:  And you get a migraine attack on one of the days you are performingpreventativetreatments (e.g., Monday) - you can perform the usual preventative treatment andanacute treatment on the same day. Then continue with your preventativetreatment onMonday, Wednesday, Friday, and Saturday as usual.  And you got a migraine attack on one of the days you are NOTperformingpreventative treatments (e.g., Sunday) – perform a 45-minute treatment whenthemigraine attack starts. Then continue with your preventative treatment onMonday,Wednesday, Friday, and Saturday as usual.

21Page|6.5. START A TREATMENT

Before you begin, make sure the smartphone Bluetooth connection isenabled. 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 protectivefilmandon the package.

Do not use the device past expiration date

Step 2: Make sure that your arm skin is clean, dry, and free fromlotion. Step 3: Turn on the device. A slow flashing (mostly on) green light indicates thedeviceison. 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. Theconnectionstatus can be viewed in the app on the top of the treatment screen. Also verifythat thereis at least one remaining treatment.

22Page|Step 5: Carefully remove the protective film from the electrodes and saveit for storingthe device and maintaining the electrode adhesiveness between uses.

Step 6: Place the device on your upper arm so that the electrodes are incontact withyour skin and the LED indicator is facing outwards. The device shouldbelocatedmidway between the elbow and the shoulder. Place the device directly ontheskinandnot on your shirt. Step 7: Adjust the armband to your size. There are 4 sizes you can choosefrom(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. Thearmband will secure the device on its location and improve the contact betweenthedevice and your skin.

23Page|Do not use the device on the heart, chest, neck, head or any other bodylocationother than the upper arm

Do not use the device over skin conditions, such as open wounds or rashes, orover swollen, red, infected or inflamed areas or skin eruptions or fragileskinonyour upper arm at the treatment location

It is important to use the device only when positioned correctly on thearm. Thedevice should be located midway between the elbow and the shoulder, ontheouter side of the arm. Step 10: To start the treatment, touch ‘Start’ in the treatment screen. The treatment hasnow begun and will stop automatically after 45 minutes. A slow flashing(mostlyoff)green light indicates the device is stimulating. Do not start a treatment before placing the device on your armDo not use the device on wet skin or when bathing, showering, duringexercise, while sweating or in high humidity

Do not use the device while driving, cycling, or operating any vehicleormachinery

Do not use the device if the electrodes become significantly dirty or damagedIf 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 deviceDo not use the device in a magnetic resonance imaging (MRI) environment

The long-term effects of chronic use of the device are unknown

In case of device malfunction, remove the device fromyour armandcontactcustomer support

24Page|In case the device fails to properly adhere to the skin, rub the electrodesusingadrop of water to improve their adhesiveness. If needed, contact customersupport

Step 11: Set the treatment intensity level, so it feels strong yet comfortableandnotpainful. The treatment starts at a default intensity of 12%. Gradually increasetheintensity as described below.

Setting intensity level:

a) Start increasing the stimulation intensity using the \"+\" button. Eachpresswill

increase the intensity by 1 unit. b) When the stimulation is painful and/or uncomfortable, reduce the intensitytotheprevious level using the \"-\" button. Each press will decrease the intensityby1unit.c) Increase and/or decrease the stimulation intensity until you findthehighestintensity that feels strong but not painful. Once you find the strongest and convenient stimulation intensity level, relax andcontinuewith the treatment. If during the treatment the sensation is not strong, if it feelsuncomfortable or painful, adjust the intensity level using the \"+\" and \"-\" buttons.  The default starting intensity level is 12%.

For effective and convenient treatment, the intensity level is individuallyset soit feels strong yet comfortable and not painful

You should monitor the activity of the device throughout its operation

25Page| Note that long/continuous presses should be avoided.  If you have significantly increased the intensity and still do not feel thestimulation,please refer to troubleshooting or contact customer support. For your safety, the intensity will increase slowly. This gradual increase will bepresentedin the app by a flashing “increasing” indication that will stop once the desiredintensityisreached. 6.5.1. TREATMENT IN PROGRESS

The progress of the treatment can be monitored by the specified time remainingof thetotal treatment duration time (45 minutes). You can pause the treatment session for up to 5 minutes by touching the pausebutton.Press ‘Resume treatment’ to resume the treatment. Each session can be pausedupto3times. If a treatment is not resumed within 5 minutes, it will be stopped automatically.When the treatment is resumed, the stimulation intensity will gradually increasetothelevel used before pausing the treatment. This gradual increase will be presentedintheapp by a flashing “increasing” indication that will stop once the desiredintensityisreached. The treatment can be stopped early at any time by touching the pause buttonandthen“Stop treatment”. Do not remove the device from your arm before the treatment hasended or has been stopped, unless the treatment cannot be stopped in the app.

During the treatment, you may experience slight muscle spasm, numbness of thehandand irritation of the skin. These sensations should resolve soon after theendoftreatment.

26Page|If you experience an uncomfortable or painful sensation that does not resolvebydecreasing the intensity, stop the treatment in the app and remove the devicefromthearm.

It is recommended that your smartphone will be protected by a password(orother security mechanism) to refrain from unwanted people to activatethedevice

Interference to the Bluetooth connectivity may occur in the vicinityofequipment emitting RF (e.g. microwave, routers, WIFI devices)

For effective results, it is recommended to avoid using other electrical devicesduring treatment

If the device was on for over 3 minutes when no treatment was inprogress, itautomatically shuts down. Turn the device back on to start a treatment.

If the “Stop” button does not respond, you can carefully remove thedevicefrom your arm

6.5.2. TREATMENT COMPLETED

Step 1: When the treatment is completed, remove the armband and the devicefromyourarm. The device will turn off automatically one minute after the treatment sessionhasended (the green light will turn off). Step 2: Apply the protective film on the electrodes (the protective filmis reusable). Step 3: Place the device in its original package or in the travel bag to storeit for next use.Step 4: Close the app.

If your migraine headache is not aborted 30 minutes following treatment, youmay administer additional treatments. Tips for Consecutive Treatments

At the end of an acute treatment, if you feel that additional treatment is required, wait at least30 minutes before the next treatment. If you administer subsequent treatments, it isrecommended to switch arms in between adjacent treatments, to reduce the likelihoodof skinredness/rash or heat sensation on the skin. There is no need nor value in administeringatotal

of more than 6 treatments on the same day. 6.6. STORING THE DEVICE FOR NEXT USE

Once the treatment has been completed, the device needs to be stored until thenexttreatment. Step 1: Verify that the electrodes are covered with the protective film Step 2: Store the device in its original package or in the travel bag inanindoorenvironment, away from direct sunlight and according to storage environmental

conditions specified in this user manual.

27Page|7. CLEANING, MAINTENANCE AND DISPOSAL

7.1. CLEANING AND MAINTENANCE

 The device can be cleaned with a dry cloth (except for the electrodes).  If the electrodes begin losing adhesion, gently rubbing one or two dropsof wateronto the gel surface may extend usage. Wait for about 30 minutes beforeplacingthe protective liner. The refresh process can be repeated multipletimesifadhesion is not resorted.  The armband can be washed with water and soap only. No bleachproductsshould be used. Do not tumble dry. Do not iron.  To minimize moisture loss, when unused, the electrodes should becoveredwiththe provided protective film and the device should be stored in its original package(sealed aluminum bag).  Contact customer support if the package and/or device labeling are damaged.  The lifetime of the electrodes varies depending on skin conditions, skinpreparation, storage and climate.  The app can be updated using the standard update procedure of themobileoperating system. Before or after a treatment, rub the electrodes using a drop of water toimprovetheir adhesiveness

After rubbing electrodes with water, wait for 30 minutes for water toabsorbbefore next use or applying protective liner. Do not clean the device with soap, alcohol, submerge in water, or scrubwithabrasive material

Do not disassemble or modify the device by yourself

7.2. DISPOSAL

To minimize moisture loss, when unused, the electrodes should be coveredwiththe provided protective film and the device should be stored initsoriginal

package

Do not expose the device to moisture and/or high humidity. If exposed, drythedevice as soon as possible

The device should be stored and cleaned according to the recommendedconditions describe in the user manual

28Page| This product should be disposed of in accordance with all applicablefederal, state and local regulations related to the disposal of electronicequipment and batteries.  If the battery has been fully discharged before use, beforeproductexpiration date or before 18 treatments have been performed, pleasecontact customer support.  Contact customer support for further information on the appropriatedisposal of device components. 8. TROUBLESHOOTING

This section lists problems or observations that you may have, the possiblecause(s)andrecommended actions. Before addressing the troubleshooting table, pleasecheckandconfirm the following:

1. Make sure that Bluetooth connection is enabled in your phone. 2. Make sure that there are treatments left in your device. 8.1. GENERAL

Problem What it may mean What to doThe device does

not power on

The device is not working Contact customer support in your region. See section 8.4. The power button was not

held long enough

Press the power button continuouslyfor 2-3seconds

The device does

not turn off

Nerivio has automatic shut

off features

 The first time the device is turnedontopair and set up, the device will shut off

automatically after 10 minutes.  For all subsequent treatments, thedevicewill give you 3 minutes to start thetreatment.  If you pause the device duringatreatment, the device will automaticallyshut off after 5 minutes if treatment isnotrestarted.  At the end of any treatment thedevicewill automatically turn off after oneminute. These built-in timers will not impact thedevice’s ability to provide twelve45-minutetreatments. The LED is

flashing very

There is an error message

on the screen

Connect the app to the device. Viewtheerror message in the app and followthe

29Page|rapidly (5 times

per second)

instructions. If the error does not appear onthe screen, wait for the device toautomatically turn off and then turnit backon

There are no treatments left

in the device

Connect the app to the device. Checkintheapp how many treatments you haveleft. The device is good for 18 treatmentsof 45minutes, provided average stimulationintensity is under 85%. If there arenotreatments left, dispose of the device. The LED is solid

green

Device malfunction Contact customer support in your region. See section 8.4.

The device does

not connect to the

app

The device is turned off If the LED is off, turn on the deviceBluetooth connection is

disabled on the phone

Enable the Bluetooth feature onyour phoneand try to reconnect

The phone and the device

are not close enough

Remove the device fromyour arm. Bringthe phone closer to the device, toarangeof1 inch (2.5 cm)

The device was

automatically shut down

since the treatment ended or

has not been initiated for a

prolonged duration of time.

If the LED is off, turn on the deviceThe smartphone has been

previously paired with a

different device

Here are some steps you can try toresolvethe connectivity issue. 1. Go to the Bluetooth settings onyour

phone and remove the device (oniPhoneclick info icon then forget device/ onAndroid click gear icon then unpair). 2. Then turn on the device and theBluetooth on your phone and pair (pleasebe sure the phone and the devicearesideby side when you pair). 3. If the device does not connect gototheMore menu at the bottomof theNerivioApp, select Nerivio device and thenselect

Connect a new Nerivio device. 4 If you still cannot pair, do a total

shutdown of your phone, restart your phoneand try to pair. General issues related to the

Bluetooth on your

smartphone

Here are some steps you can try toresolvethe connectivity issue. Please donot skipany steps:

1. Turn your phone off, turnyour phoneback on

30Page|2. Turn Bluetooth off and backonagain in the settings menu. Donot

try to pair the device fromtheBluetooth menu. 3. Turn on the device and pair (pleasebe sure the phone and thedeviceare side by side when youpair). 4. If the device does not connect gotothe More menu at the bottomof theNerivio App, select Neriviodeviceand then select Connect anewNerivio device.

If you still cannot pair, rest networksettingson your smartphone

The stimulation is

not felt

The treatment has not

started yet or has been

stopped or paused

Touch “Start” or “Resume treatment” inthe“Treatment” screen

The stimulation intentisty is

too low

Increase the stimulation using the“+” buttonin the treatment screen, until youfeel thestimulation

The protective film was not

removed

Remove the protective filmfromtheelectrodes

The electrodes begin losing

adhesion

Gently rub with your finger one or twodropsof water onto the gel surface of theelectrodes. Wait for 10 minuts for better

effect. You can repeate this processseveral

times to improve dry electrodes adhesion. The adhesive surface of the

device is damaged Replace the device

31Page|8.2. MAIN ERRORS AND MESSAGES

Errors and messages

displayed on the screen

What it may mean What todoNerivio is not properly placed. Make sure that the protective

film was removed and that the

electrodes are in contact with

your skin

The device is not properly

placed on the arm and/or the

electrodes are not in contact

with your skin

Make sure the protectivefilmwas removed fromtheelectrodes. The device shouldbeplaceddirectly on the skinof thearmNo treatments left No remaining treatments The device cannot beused. Replace the deviceor orderanew device. Nerivio is shutting down since

no treatment is performed. Turn it back on to start a

treatment

The device was on for a

specific duration of time and

no treatment was performed

Turn on the deviceNo Nerivio devices were found

Bluetooth is off Enable Bluetooth onyour

smartphone

The device is turned off Turn on the deviceThe device is too far from the

smartphone

Bring the phone closer tothedevice, to a rangeof 1inch(~2.5 cm)

Authentication failed The device has already been

associated with a different

user

Connect to a different Nerivio8.3. LED STATUS

LED indication Status

Flashing very rapidly (5 times per second) The device is shutting down or an error

occurred or there are no treatments left inthedevice

Solid green Device malfunction

Flashing slowly (mostly on) The device is ready to be connectedtotheapp

Flashing rapidly The device is connected to a smartphone

32Page|LED indication Status

Flashing slowly (mostly off) The device is in a treatment process

8.4. CUSTOMER SUPPORT

Customer support is available to answer any questions you may have about your Neriviodevice. The service lifetime of the Nerivio is until product expiration date. The battery operation time is 810 minutes (i.e., 18 treatments of 45 minutes) if

stored at ambient temperature of 23±2℃, provided average stimulationintensityis under 85%

Local support in the region can be obtanied according to the following table. For anyterritotiry that is not listed, please use Global Inquiries. USA Global Inquiries

Theranica USA Inc. Address: 100 Somerset Corporate Boulevard

2nd Floor – Suite 160

Bridgewater, NJ 08807

USA

Nerivio Cares Customer Support:

Phone: 1-937-637-4846

Email: support@nerivio.com

Web: https://nerivio.com/

Theranica Bio-ElectronicsLTD. Address: 4 Ha-Omanut St. Netanya 4250438,

Israel

Email: info@theranica.comWeb: www.theranica.comFax: +972-72-390-9762Israel India

DaphneMed Agencies LTD. Phone: +972- 54-5996029 | +972-77-3630400

Web: https://www.nerivio-il.co.il

Email: info@daphnemed.com

Dr. Reddy’s Labs India, andPorteaPhone: 1800-123-2360

Email: neriviodrl@porteamedical.comWeb: www.nerivio.in

Germany Spain

betapharm

Email: kontakt@nerivio.de

Phone: 0800 589 26 38

Reddy Pharma Iberia S.A. Email: soportepacientes@nerivio.esPhone: 93-355-49-16

33Page|Web: www.nerivio.de Web: www.nerivio.es

South Africa United KingdomDr. Reddy's Laboratories (Pty) Ltd. Phone: 018 011 5205

Email:support@nerivio.co.za

Web: www.nerivio.co.za

Dr. Reddy’s Laboratories(UK) LTDEmail: info@nerivio.co.uk

Web: www.nerivio.co.uk

Hong Kong and Macau, China /

PIER 88 HEALTH HONG KONG LIMITED

Local Responsible Person (LRP)

Phone: +852 60548188

Email:nerivio@pier88health.com

/

Support information for your local region may be updated from time to time. For themostup to date listings, please contact your Local Responsible Person (LRP). 9. OPERATION SPECIFICATION

9.1. ENVIRONMENT OPERATING CONDITIONS

Operating temperature range: +5º to +40º C (41'F-104'F)

Relative humidity range: 35%-70% RH, with no condensing

Atmospheric pressure: 70-106 kPa

9.2. ENVIRONMENTAL STORAGE AND TRANSPORTATION CONDITIONSBETWEEN USES

Temperature range: +10º to +27º C (50'F-80.6'F)

Relative humidity range: 40%-70% RH, with no condensing

Atmospheric pressure: 70-106 kPa

9.3. ENVIRONMENTAL TRASNPORTATION AND STORAGE CONDITIONSTemperature range: +10º to +27º C (50'F-80.6'F)

Relative humidity range: 40%-70% RH, with no condensing

Atmospheric pressure: 70-106 kPa

9.4. ELECTRICAL PROPERTIES

Battery type: Primary cell Li-MnO2, 3.0 V, 1.2 Ah

Maximum Voltage: 3.3V

34Page|Maximum Current 40mA

Frequency 100-120Hz

Charger Input: N/A – the battery is not rechargeable in thedevice. Charger output: N/A – the battery is not rechargeable in thedevice. Battery lifetime 810 minutes if stored at ambient temperatureof

23±2℃.

10. TECHNICAL SPECIFICATIONS

Number of channels 1

Waveform Biphasic rectangular, modulated

Net charge (µC per pulse) 0 (charge is balanced by using a symmetrical, biphasicpulse)

Max output voltage

500Ω 20V

2KΩ 60V

10KΩ 60V

Max output current

500Ω 40mA

2KΩ 30mA

10KΩ 6mA

Maximum phase charge

500Ω

8 µC

Maximum average current

500Ω

176mA

Maximum current density

(peak) 500Ω

16 mA/cm²

Do not disassemble, crush, incinerate or short-circuit the battery. This couldcause a fire, injury, burns, or other hazards. Do not attempt to recharge or detach the battery

Recycle or dispose the device in accordance with disposal instructionsintheuser manual

35Page|Maximum current density

(r.m.s) 500Ω

0.34 mA/cm² Maximum average current

density (abs value) 500Ω

0.07 mA/cm² Maximum average power

density 500Ω

1.41mW/cm² Frequency 100-120Hz, average 110Hz

Primary phase duration

[µSec] 200

Pulse duration [µSec] 400

Burst mode No

Program duration [min] 45

Electrode area 25cm2

Electrode compliance

with 21 CFR 898

Yes

Electrode cable No

Indication display Device LED Via the mobile application, if connected-On/off status Yes Yes

-Wireless connection Yes Yes

-Low battery No Yes (remaining number of treatments)

-Current level No Yes (stimulation intensity)

-Output mode Yes Yes (stimulation time indicator)

-Time to cut-off No Yes (stimulation time indicator)

Power source Integrated, non-rechargeable, primary cell Li-MnO2batteryOperation time: 810 minutes (i.e. 18 treatments of 45minutes), provided average stimulation intensity is under

85%*. *Usage at average intensity above 85% will reduce the number of

treatments. The expected number of 45-minute treatments maybeinthe range from 15 to 18. Processor control Yes

Wireless control Yes

36Page|Wireless communication Frequency range: 2.400-2.4835 GHz

Modulation: Gaussian frequency shift

Output power: ≤0 dBm

Automatic overload trip Yes, limiter for max current and voltage

Automatic no load trip Yes, out-of-range load detection

Automatic shutdown Yes, timer

Simulation intensity control Yes, current amplitude is adjustable by the user

Wireless communication interference

This device operates in the 2.400-2.4835 GHz ISM band. In case this deviceisusedaround other wireless devices such as microwave and wireless LAN, whichoperateatthe same frequency band as this device, interference between this deviceandsuchother devices may occur. If an interference occurs before the treatment hasbegun, thetreatment may not start. Once the treatment has started, the device maintainsthetreatment parameters (shape and frequency of pulses during stimulation, intensityandduration) autonomically and does not require any further control. However, theappmaynot enable you to stop the treatment or adjust the intensity, which may result inanuncomfortable feeling. If such sensation occurs, please remove the device fromyourarmwithout touching the electrodes, stop the operation of the other devices or moveawayfrom the interfering source. 11. SMARTPHONE REQUIREMENTS

Please contact your Local Responsible Person (LRP) to obtain informationaboutsmartphone requirements. 12. CYBERSECURITY

The Nerivio system software is comprised of the Nerivio device embeddedsoftware(“Firmware”), an application backed service (“Backend”) hosted on AlibabaCloudandoperated by the company, and an application frontend (“Client”) hosted by Neriviomobileapplication on the user’s smartphone. The Nerivio is a closed system, whichdoesnotallow installation of additional external components, nor ability of the user toupgradeormodify the device Firmware or Backend. The Client software exposes onlyauserinterface (UI). The Backend is accessible only to authorized company personnel over a secureHTTPScommunication channel. The company operates the Backend and assumesfull

responsibility for maintaining its cybersecurity, including patching, and securingtheinfrastructure and application code, as well as security incidents management. The Client software runs on a mobile platform that is the responsibility of theuser. Thedevice Firmware and the Client software are not designed to detect or report onsecurity

37Page|events. The company recommends selecting a strong user password whencreatingNerivio account and protecting your mobile platform by a password (or other securitymechanism) to refrain from unwanted people to activate the device or accessyourpersonal information. To verify user’s account validity, the Nerivio systemincludesauthentication and verification through the user’s email.

Instructions for Security

The following cybersecurity controls are recommended to increase cybersecurityof theClient software and user’s mobile platform:  The mobile platform should require authenticated access via user credentials. Youare advised to lock your smartphone with a password or any other means(e.g.biometric, pin code or other).  Restrict unauthorized physical access to the mobile platformand Neriviodevice. Keep the mobile operating system on the mobile platformup to datewiththelatest security updates.  Download the Nerivio mobile application only from an official applicationstoreoutlined in this user manual.  Keep the Nerivio application software up to date. It is recommendedtoallowautomatic upgrade of Nerivio mobile application on your mobile platform. For additional information on data protection and privacy refer to www.nerivio.comprivacy policy. 13. POTENTIAL ADVERSE REACTIONS

 People with sensitive skin may experience a rash or redness of the skinundertheelectrodes. 14. CLASSIFICATION

 Internally powered ME Equipment  Type BF applied part  Enclosure IP22

 Continuous operation

15. EMC STATEMENT

With the increased number of electronic devices such as PC’s and mobile(cellular)telephones, the Nerivio device may be susceptible to electromagnetic interferencefromother devices, even if they comply with CISPR emission requirements. ElectromagneticIt is recommended that your smartphone will be protected by a password(orother security mechanism) to refrain from unwanted people to activatethedevice

38Page|interference may result in incorrect operation of the Nerivio device andcreateapotentially unsafe situation. The Nerivio device should not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) withtheaim to prevent unsafe product situations, the IEC60601-1-2 standardhasbeenimplemented. This standard defines the levels of immunity to electromagneticinterferences as well as maximum levels of electromagnetic emissions for medical

devices. The Nerivio medical device conforms with the IEC60601-1-2 standard for bothimmunityand emissions. The Nerivio device requires special precautions regarding EMCand needstobeinstalled and used according to the EMC information provided in this manual:  Do not use any unspecified accessories with the Nerivio device. This mayresult inincreased emissions or decreased immunity of the device.  The Nerivio device should not be used adjacent to or stackedwithotherequipment. In case adjacent or stacked use is necessary, the Neriviodeviceshould be monitored to verify normal operation in the configurationinwhichit isused.  Do not use devices which generate strong electrical or electromagneticfieldsinproximity to the Nerivio device. This may result in incorrect operationof thedeviceand create a potentially unsafe situation. In order to reduce theriskof EMinterference, it is recommended to keep a minimum distance of 30 cm(12inches)between the device and other electromagnetically radiating devices. Verifycorrectoperation of the device if the distance is shorter. The Nerivio device complies with immunity tests described below. 15.1. ELECTROMAGNETIC TEST RESULT SUMMARY

Test Standard Class /

Severity level

Test

result

Emission

Radiated emission

Frequency range:

301000 MHz

IEC 60601-1-2 section 7.1 /

CISPR 11

Group 1 Class B CompliesETSI EN 301 489-1 section 8.2;

ETSI EN 301 489-17 section 7.1/

EN 55032

Class B CompliesRadiated emission

Frequency range:

10 GHz-60 GHz

ETSI EN 301 489-1 section 8.2;

ETSI EN 301 489-17 section 71

EN 55032

Class B CompliesImmunity

Immunity from

Electrostatic

discharge (ESD)

IEC 60601-1-2 section 8, Table 4/

IEC 61000-4-2

8 kV contact &

15 kV air discharges

CompliesETSI EN 301 489-1 section 9.3;

ETSI EN 301 489-17 section 7.2/

EN 61000-4-2

4 kV contact &

8 kV air discharges

Complies

39Page|Test Standard Class /

Severity level

Test

result

Immunity from radiated

electromagnetic fields

IEC 60601-1-2 section 8, Table 4/

IEC 61000-4-3

10 V/m, 80 MHz ÷ 2.7 GHz, 80% AM, 1 kHz

CompliesImmunity from Proximity

field

from wireless

communications

equipment

IEC 60601-1-2 section 8, Table 9/

IEC 61000-4-3

List of frequencies,

from 9 V/m up to 28

V/m, PM (18 Hz or 217 Hz), FM 1 kHz

CompliesImmunity from radiated

electromagnetic fields

ETSI EN 301 489-1 section 9.2;

ETSI EN 301 489-17 section 7.2/

EN 61000-4-3

3 V/m, 80 MHz - 6 GHz, AM 80% @1 kHz

CompliesImmunity from power

frequency magnetic field

IEC 60601-1-2 section 8, Table 4/

IEC 61000-4-8

30 A/m @50 Hz & 60

Hz

CompliesNote: this table is formatted based on IEC60601-1-2. 15.2. ELECTROMAGNETIC EMISSIONS

The Nerivio is intended for use in the electromagnetic environment specifiedbelow.Please assure that the device is used according to these specifications. Note: the following tables is formatted based on IEC60601-1-2. Electromagnetic emissions IEC 60601-1-2

Emissions Test Compliance Electromagnetic Environment - GuidanceRF emissions

CISPR 11

Group 1 The Nerivio uses RF energy only for itsinternal function. Therefore, its RFemissions are very low and are not likelytocause any interference in nearby electronicequipment. RF emissions

CISPR 11

Class B

The Nerivio is suitable for use in all

establishments, including domestic

establishments and those directly

connected to the public low-voltagepower

supply network that supplies buildingsusedfor domestic purposes

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage fluctuations /

Flicker emissions

IEC 61000-3-3

Not applicable

15.3. ELECTROMAGNETIC IMMUNITY

The Nerivio is intended for use in the electromagnetic environment specifiedbelow.Please assure that the device is used according to these specifications Electromagnetic immunity IEC 60601-1-2

Immunity Test IEC 60601-1-2 test

level

Compliance Level Electromagnetic Environment- Guidance

Electrostatic

discharge, ESD

(IEC 61000-4-2)

Contact discharge:

±8 kV

Contact discharge:

±8 kV

The relative humidity shouldbeat

least 5%

Air discharge: Air discharge:

40Page|Electromagnetic immunity IEC 60601-1-2

Immunity Test IEC 60601-1-2 test

level

Compliance Level Electromagnetic Environment- Guidance

±15 kV ±15 kV

Electrical fast

transient / burst

(IEC 61000-4-4)

Power supply lines:

±2 kV

Longer input / output

lines: ±1 kV

Not Applicable

Not Applicable

Surge on AC

mains lines

(IEC 61000-4-5)

Common mode:

±2 kV

Not Applicable

Differential mode:

±1 kV

Not Applicable

Voltage dips, short interruptions

and voltage

variations on

power supply

lines

(IEC 61000-4-11)

0% UT

for 0.5 cycle

Not Applicable

0% UT

for 1 cycle

Not Applicable

70% UT

for 25 cycles

Not Applicable

0% UT

for 5 s

Not Applicable

Power frequency

(50/60 Hz)

magnetic field

(IEC 61000-4-8)

30 A/m 30 A/m

Note: UT is the A.C. mains voltage prior to application of the test level. Electromagnetic immunity IEC 60601-1-2

Portable and mobile RF

communications equipment shouldbe used no closer to any part of theNerivio, including cables, thantherecommended separation distancecalculated from the equationapplicable to the frequency of thetransmitter Recommended separationdistance

Conducted RF

(IEC 61000-4-6)

3 V rms

150 kHz to 80 MHz

Not Applicable d = 1.16 √P 150 kHz to 80MHz6 V rms

The ISM bands and

the amateur radio

bands between 150

kHz to 80 MHz

Not Applicable d = 058 √P 150 kHz to 80MHz(The ISM bands and the amateur

radio bands)

Radiated RF

(IEC 61000-4-3)

10 V/m

80 MHz to 27 GHz

10 V/m

80 MHz to 27 GHz

d = 035 √P 80 MHz to 800MHzd = 07 √P 800 MHz to27GHz

41Page|Electromagnetic immunity IEC 60601-1-2

IEC 60601-1-2:2014

Table 9

(Up to 28 V/m at

certain frequencies)

IEC 60601-1- 2:2014 Table 9

(Up to 28 V/m at

certain frequencies)

Where P is the maximumoutput

power rating of the transmitter inwatts (W) according tothetransmitter manufacturer anddistherecommended separation Distancein meters (m). Field strengths fromfixedRFtransmitters, as determinedbyanelectromagnetic site survey

a

, shouldbe less than the compliancelevel ineach frequency range.

Interference may occur in thevicinityof equipment marked withthefollowing symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affectedbyabsorption and reflection from structures objects and people. a Field 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 theelectromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measuredfield strength in the location in which the Nerivio is used exceeds the applicable RF compliance level above, the Nerivio shouldbeobserved to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re- orienting or relocating the Nerivio. 15.4. RECOMMENDED SEPARATION DISTANCES

Recommended separation distance between portable and mobile RF communications equipment and the NMNerivio is intended for use in an electromagnetic environment in which radiated RF disturbances

are controlled. The customers or the users of Nerivio can help prevent electromagnetic

interference by maintaining a minimum distance between portable and mobile RF

communications equipment (transmitters) and Nerivio as recommended below, according to themaximum output power of the communications equipment. Output Power of

Transmitter in Watt

Separation distance according to frequency of transmitter in meter

150 kHz to 80 MHz 80 MHz to 800

MHz

800 MHzto2.7GHz

d = 1.16 √ d = 0.58 √ d = 0.35 √ d = 0.7√001 012 006 004 0070.1 0.37 0.18 0.11 0.221 1.16 0.58 0.35 0.710 367 18 11 22100 11.6 5.8 3.5 7.0For transmitters rated at a maximum output power not listed above, the recommended

separation distance d in meters (m) can be estimated using the equation applicable to the

frequency of the transmitter, where P is the maximum output power rating of the transmitter in

watts (W) according to the transmitter manufacturer

42Page|Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects, and people. 16. FCC RADIO FREQUENCY INTERFERENCE STATEMENT

FCC Registration Number (FRN): 0027054477. This equipment has been tested and found to comply with the limits of ClassBdigital

device, pursuant to part 15 of the FCC Rules. These limits are designedtoprovidereasonable protection against harmful interference in a residential installation. Thisequipment generates, uses and can radiate radio frequency energy and, if not installedand used in accordance with the instructions, may cause harmful interferencetoradiocommunications. However, there is no guarantee that interference will not occur inainstallation. If this equipment causes interference with other devices, whichmaybedetermined by turning the equipment off and on, the user is encouraged totrytocorrectthe interference by one or more of the following measures: • Reorient or relocate the device receiving the interference

• Increase the separation between the equipment • Connect the equipment into an outlet on a circuit different fromthat to whichthedeviceis connected. • Consult the manufacturer or field service technician for help

Theranica Bio-Electronics LTD. is not responsible for any radio or communicationinterference caused by using other than specified or recommended cables andbatteryorby unauthorized changes or modifications to this equipment. Changes or modificationsnot expressly approved by the manufacturer could void the user’s authoritytooperatethe equipment. This device complies with part 15 of the FCC Rules. Operation is subject tothefollowingtwo conditions:

1. This device may not cause harmful interference, and

2. This device must accept any interference received, including interferencethat maycause undesired operation.

43Page|17. APPLICABLE STANDARDS

 EN 60601-1:2006/A2:2021 / IEC 60601-1 edition 3.2 b:2020 Medical electrical

equipment, part 1: General requirements for basic safety andessential

performance.  EN 60601-1-2:2015/A1:2021 / IEC 60601-1-2 edition 4.1 a:2020 Medical electrical

equipment- Part 1-2: General requirements for safety – collateral standard:Electromagnetic compatibility –Requirements and tests.  EN 60601-2-10:2015/A1:2016 / IEC 60601-2-10 edition 2.2 b:2023 Requirementsfor the safety of nerve and muscle stimulators

 ETSI EN 301 489-1 V2.2.3:2019 ElectroMagnetic Compatibility (EMC) standardfor radio equipment and services; Part 1: Common technical requirementsHarmonized Standard covering the essential requirements of article3.1(b)ofDirective 2014/53/EU and the essential requirements of article 6of Directive2014/30/EU

 ETSI EN 301 489-17 V3.2.4:2020 ElectroMagnetic Compatibility (EMC) standardfor radio equipment and services; Part 17: Specific conditions for BroadbandDataTransmission Systems; Harmonised Standard for ElectroMagnetic Compatibility

44Page|Theranica Bio-Electronics LTD. 4 Ha-Omanut St., Netanya 4250438, Israel

Tel: +972-72-3909-763, Fax: +972-72-3909762 © 2018 Theranica Bio-Electronics LTD. All Rights Reserved. www.theranica.com ART No. LBL-NM-0014-HK, Rev. 1.0, Jun 2025

Nerivio®