Nerivio Migra ® A 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. 45 Ha-Melakha St., Netanya 4250574, 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 episode 16 6.3. Storing the device for next use 23 6.4. Reviewing your migraine diary 23 7.
1. INTRODUCTION 1.1. ABOUT THIS MANUAL This manual provides the information necessary for the user to effectively use the Nerivio Migra® 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 an ON button. Flexible arm sleevelet 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.
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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.
4. SAFETY 4.1. CONDITIONS FOR USE 4.1.1. INDICATION FOR USE The Nerivio Migra® is indicated for acute treatment of migraine with or without aura, for 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. II. III. The device should not be used by people with congenital 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.
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.
The device should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, the Nerivio Migra® 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 Migra® device. This may result in incorrect operation of the device and create a potentially unsafe situation.
Do not attempt to perform any procedure before carefully reading all the instructions Do not use the device if the package was damaged during shipment 6.1.1. DOW NLOADING AND INSTALLING THE APPLICATION Step 1: Verify that your phone operating system is compatible with the Nerivio Migra app (Android versions 6 to 9 and iOS versions 9 to 12.1.4). Step 2: Download and install the “Nerivio Migra” application App store (depending on your operating system). via Google play or Step 3: Open the application.
Step 4: A quick introduction will be presented. Read it by swiping the screens to the left and touch “Done” when finished. You can skip it by touching “Skip intro”. Step 5: As you begin using the app, it may ask for permissions. Please allow these permissions so that the app works properly. 6.1.2. THE APP HOME SCREEN The home screen provides access to information about your migraine treatments and the Nerivio Migra system.
The home screen includes: Treatment – This section enables to initiate, control, monitor and stop a treatment session. Migraine diary – This section enables you to review and edit your migraine symptoms.
Step 2: In the home screen touch “Settings” and then touch “Connect”. The device and the smartphone should be in proximity of less than 1 inch. When the device is successfully connected to the app, there will be a fast flashing green indicator light on the device. The connection status can be viewed in the app on the bottom left corner of the screen. If a connection has not been established, make sure that Bluetooth is enabled in your smartphone.
when no treatment was initiated, it automatically shuts down. Turn it back on to start a treatment. 6.2. TREATING A MIGRAINE EPISODE The treatment should be performed at the onset of a migraine episode and takes 45 minutes. 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). Before you begin, make sure the smartphone Bluetooth connection is enabled.
Step 4: Open the app and confirm the device is connected successfully. The connection status can be viewed in the app on the bottom left corner of the screen. Also verify that there is at least one remaining treatment on the bottom right corner of the app screen. 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: Wrap the sleevelet around the device on your arm to improve the contact between the device and your skin.
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.
a) Start increasing the stimulation intensity using the "+" button. Each press will increase the intensity by 1 unit. b) When the stimulation is painful and/or uncomfortable, reduce the intensity to the previous level using the "-" button. Each press will decrease the intensity by 1 unit.
6.2.1. TREATMENT IN PROGRESS The progress of the treatment can be monitored by the treatment progress bar and by the specified amount of time that has passed out of the total treatment duration time (45 minutes). You can pause the treatment session for 5 minutes by touching ‘Pause’. Press ‘Resume’ to restart. Each session can only be interrupted 3 times. If a treatment is not resumed within 5 minutes, it will be stopped automatically. The treatment can be stopped early at any time by touching “Stop”.
During the treatment, you may experience slight muscle spasm, numbness of the hand and irritation of the skin. These sensations should resolve soon after the end of treatment. If you experience an uncomfortable or painful sensation that does not resolve by decreasing the intensity, stop the treatment using the “Stop” button or remove the device from your arm. Note that if the device was on for over 3 minutes when no treatment was in progress, it automatically shuts down.
Step 3: Place the device in its original package or in the travel bag store it for next use. Step 4: Close the app. Note that if your migraine headache is not aborted 30 minutes following treatment, you may administer additional treatments. 6.3. STORING THE DEVICE FOR NEXT USE Once the treatment has been completed, the device needs to be stored until the next treatment. Step 1: Verify that the electrodes are covered with the protective film.
• • • • The sleevelet can be machine washed at 80°F or 30°C. No bleach products should be used. Do not tumble dry. To minimize moisture loss, when unused, the electrodes should be covered by the provided protective film and the device should be stored in its original package. Contact customer support if the package and/or device labeling are damaged. The life of the electrodes varies depending on skin conditions, skin preparation, storage and climate.
The LED is flashing very rapidly (5 times per second) The LED is solid green No communication between the app and the device The ON button was not held long enough Press the ON button continuously for 2-3 seconds There is an error message on the screen View the error message in the app and follow the instructions.
The treatment screen of the app is not responding No communication between the app and the device See “what to do” in the problem of “No communication between the app and the device” The device is turned off If the LED is off, turn on the device Device malfunction Contact customer support at support@theranica.com The app is not working Restart the app 8.2.
Unable to connect using proximity. Do you want to enter device MAC address? The device could not be paired with the app by mere proximity Enter device mac address for manual paring. Locate the mac address of the device on the label in the external part of the device. The mac address includes 12 letters and digit separated by colons in the format of: xx:xx:xx:xx:xx:xx. Enter it to the MAC address field without the colons. The device is shutting down since no treatment is performed.
8.3. LED STATUS LED indication Status Flashing very rapidly (5 times per second) An error occurred or there are no treatments left in the device Solid green Device malfunction Flashing slowly (mostly on) The device is ready to be connected to the app Flashing rapidly The device is connected to a smartphone 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 Nerivio Migra® device.
Temperature range: +10º to +27º C (50'F-80.6'F) Relative humidity range: 40%-50%, with no condensing Atmospheric pressure: 70-106 kPa 9.3. ENVIRONMENTAL TRASNPORTATION AND STORAGE CONDITIONS Temperature range: +10º to +27º C (50'F-80.6'F) Relative humidity range: 40%-50%, 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.
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 1.76mA Maximum current density (peak) 500Ω 1.6 mA/cm² 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.
-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-MnO2 battery Operation time: 540 minutes (12 treatments of 45 minutes). Processor control Yes Wireless control Yes Wireless communication Frequency range: 2.400-2.
• • • 800MHz or more CPU, internal memory of 512kB or more, and internal storage of at least 4GB BT4.0 and above connectivity capabilities Supported operating system - iOS versions 9-12.1.4 and Android versions 6-9. 12. POTENTIAL ADVERSE REACTIONS • People with sensitive skin may experience a rash or redness of the skin under the electrodes. 13. CLASSIFICATION • Internally powered ME Equipment • Type BF applied part • Enclosure IP22 • Continuous operation 14.
interference, 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 if the distance is shorter. The Nerivio Migra® device complies with immunity tests described below. 14.1. ELECTROMAGNETIC TEST RESULT SUMMARY Test Emission Radiated emission Frequency range: 30-1000 MHz Radiated emission Frequency range: 1.0 GHz-6.
Electromagnetic emissions IEC 60601-1-2 Compliance Electromagnetic Environment - Guidance Group 1 The Nerivio Migra® uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Electromagnetic immunity IEC 60601-1-2 IEC 60601-1-2 test Compliance Level Electromagnetic Environmentlevel Guidance Note: UT is the A.C. mains voltage prior to application of the test level. Immunity Test Electromagnetic immunity IEC 60601-1-2 Portable and mobile RF communications equipment should be used no closer to any part of the Nerivio Migra®, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Electromagnetic immunity IEC 60601-1-2 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 the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
• Reorient or relocate the device receiving the interference • Increase the separation between the equipment • Connect the equipment into an outlet on a circuit different from that to which the device is connected. • Consult the manufacturer or field service technician for help Theranica Bio-Electronics Ltd. is not responsible for any radio or communication interference caused by using other than specified or recommended cables and battery or by unauthorized changes or modifications to this equipment.
Nerivio Migra® Theranica Bio-Electronics LTD. 45 Ha-Melakha St., Netanya 4250574, 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-0014-1.1, Rev. 1.
