Nerivio ® A wireless non-invasive neuromodulation device for the acute treatment of migraine USER MANUAL
© 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: +972-72-3909-763, Fax: +972-72-3909762 Web: www.theranica.
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 18 6.3. Storing the device for next use 26 6.4. Reviewing your migraine diary 27 7.
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 support@theranica.com. 1.2.
1.3. PRODUCT FUNCTIONS • • • • • The device is battery-powered; the battery is internal, integrated, and nonrechargeable. 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.
3. LABELS AND SYMBOLS Symbol Description Read and fully understand user manual before using this device. The user manual is available at https://theranica.com/support-patient/ www.theranica.
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.
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. 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. II. III. The device should not be used by people with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
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.
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.
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.
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. 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).
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 an account, 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.
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. Power button LED indicator 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.
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 (home screen), a diary screen and a more screen. Treatment screen – This screen enables to initiate, control, monitor, pause and stop a treatment session.
Diary screen – This screen enables you to track and edit your treatment sessions and migraine headaches.
Post-treatment assessment – Select this to report your migraine symptoms at 2 hours and at 24 hours post-treatment. When a post-treatment assessment is available, a green badge will be presented on the More menu. Terms & Conditions – Select this to view the terms and conditions. Help – This screen provides access to the Nerivio user manual, to instructional videos that explain how to how to treat a migraine headache with the device and enables to contact customer support via email.
Step 1: Check the device expiration date on the label located on the protective film and on the package. 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.
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.
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.
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.
Step 11: Set the treatment intensity level, so it feels strong yet comfortable and not painful. The treatment starts at a default intensity of 12%. Gradually increase the intensity as described below. 2. Reduce the intensity to the previous level when the stimulation is painful and/or uncomfortable, 1. Increase the intensity Setting intensity level: a) Start increasing the stimulation intensity using the "+" button. Each press will increase the intensity by 1 unit.
• • • The default starting intensity level is 12%. Note that long/continuous presses should be avoided. If you have significantly increased the intensity and still do not feel the stimulation, please refer to troubleshooting or contact customer support. For your safety, the intensity will increase slowly. This gradual increase will be presented in the app by a flashing “increasing” indication that will stop once the desired intensity is reached.
You can pause the treatment session for up to 5 minutes by touching the pause button. Press ‘Resume treatment’ to resume the treatment. Each session can be paused up to 3 times. If a treatment is not resumed within 5 minutes, it will be stopped automatically. When the treatment is resumed, the stimulation intensity will gradually increase to the level used before pausing the treatment.
It is recommended that your smartphone will be 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, WIFI devices) For effective results, it is recommended to avoid using other electrical devices during treatment If the device was on for over 3 minutes when no treatment was in progress, it automatically shuts down.
The device should be stored and cleaned according to the recommended conditions describe in the user manual 6.4. REVIEWING YOUR MIGRAINE DIARY Keeping detailed records of migraine episodes can help in migraine management. The symptoms recorded during a treatment will be saved in a migraine diary that can be reviewed at any time via the app. Touch “Diary” to review your migraine symptoms. You can also report a current migraine headache and records your symptoms in the diary even if the device is not used.
• • • This product should be disposed of in accordance with all applicable federal, state and local regulations related to the disposal of electronic equipment and batteries. If the battery has been fully discharged before use, before product expiration date or before 12 treatments have been performed, please contact customer support. Contact customer support for further information on the appropriate disposal of device components. 8.
The phone and the device are not close enough Bring the phone closer to the device, to a range of 1 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.
Errors and messages displayed on the screen No Nerivio devices were found Authentication failed What it may mean What to do Bluetooth is off Enable Bluetooth on your smartphone The device is turned off Turn on the device The device is too far from the smartphone Bring the phone closer to the device, to a range of 1 inch (~2.5 cm) The device has already been associated with a different user Connect to a different Nerivio 8.3.
Address: Email: Web: Fax: 4 Ha-Omanut St. Netanya 4250438, Israel support@theranica.com www.theranica.com +972-72-390-9762 9. OPERATION SPECIFICATION 9.1. ENVIRONMENT OPERATING CONDITIONS Operating temperature range: +5º to +40º C (41'F-104'F) Relative humidity range: 35%-65% Atmospheric pressure: 70-106 kPa 9.2. ENVIRONMENTAL STORAGE AND TRANSPORTATION CONDITIONS BETWEEN USES Temperature range: +10º to +27º C (50'F-80.
Do not attempt to recharge or detach the battery Recycle or dispose the device in accordance with disposal instructions in the user manual 10. TECHNICAL SPECIFICATIONS Number of channels 1 Waveform Biphasic rectangular, modulated Net charge (µC per pulse) 0 (charge is balanced by using a symmetrical, biphasic pulse) 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 1.
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 (
Wireless communication interference This device operates in the 2.400-2.4835 GHz ISM band. In case this device is used around other wireless devices such as microwave and wireless LAN, which operate at the same frequency band as this device, interference between this device and such other devices may occur. If an interference occurs before the treatment has begun, the treatment may not start.
• • • Do not use any unspecified accessories with the Nerivio device. This may result in increased emissions or decreased immunity of the device. The Nerivio device should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the Nerivio device should be monitored to verify normal operation in the configuration in which it is used. Do not use devices which generate strong electrical or electromagnetic fields in proximity to the Nerivio device.
14.2. ELECTROMAGNETIC EMISSIONS The Nerivio is intended for use in the electromagnetic environment specified below. Please assure that the device is used according to these specifications. Note: the following tables is formatted based on IEC60601-1-2:2007.
Immunity Test (IEC 61000-4-11) Electromagnetic immunity IEC 60601-1-2 IEC 60601-1-2 test Compliance Level Electromagnetic Environmentlevel Guidance 70% UT Not Applicable for 25 cycles 0% UT for 5 s 30 A/m Not Applicable Power frequency 30 A/m (50/60 Hz) magnetic field (IEC 61000-4-8) Note: UT is the A.C. mains voltage prior to application of the test level.
Electromagnetic immunity IEC 60601-1-2 Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation Distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.
15. FCC RADIO FREQUENCY INTERFERENCE STATEMENT FCC Registration Number (FRN): 0027054477. This equipment has been tested and found to comply with the limits of Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Nerivio ® Theranica Bio-Electronics LTD. 4 Ha-Omanut St., Netanya 4250438, Israel Tel: +972-72-3909-763, Fax: +972-72-3909762 www.theranica.com © 2018 Theranica Bio-Electronics LTD. All Rights Reserved. ART No. LBL-NM-0014-2.0, Rev. 2.
