NEUROLIEF Relivion MG User Manual
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NEUROLIEF Relivion MG User Manual

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Neurolief Relivion® User Manual
USER MANUAL
For Patients
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Summary of Contents for NEUROLIEF Relivion MG

  • Page 1 Neurolief Relivion® User Manual USER MANUAL For Patients...
  • Page 2 MG User Manual IMPORTANT NOTICE Copyright © 2021 Neurolief Ltd. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system or translated into any language or any computer language, in any form or by any third party, without the prior written permission of Neurolief Ltd.
  • Page 3 Neurolief Relivion ® MG User Manual SUMMARY OF CLINICAL DATA The safety and effectiveness of the Relivion® MG device for the treatment of migraine with and without Aura was demonstrated in a prospective, randomized, parallel-group, sham-controlled clinical trial- the RIME study. The study included 131 patients (109 females and 22 males) experiencing migraine attacks with or without aura.
  • Page 4 Neurolief Relivion ® MG User Manual USER MANUAL PURPOSE This user manual provides the necessary instructions for safely operating the Relivion MG in accordance with ® its function and intended use. These instructions include – • An explanation of the function of controls and indicators.
  • Page 5 Neurolief Relivion ® MG User Manual SYSTEM SYMBOLS Table 1: System Symbols Symbol Description Consult instruction for use Class II equipment Prescription only. Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
  • Page 6 Neurolief Relivion ® MG User Manual Symbol Description RF transmitter Waste Electrical and Electronic Equipment Directive (WEEE) Single use Keep away from sunlight Do not use if package is damaged Atmosphere pressure limitation Humidity limitation Fragile, handle with care European conformity...
  • Page 7 Subjects with recent (less than three months) brain or facial trauma should not use the device. • Subjects with skin abrasions on the forehead or occiput at the contact area of the Relivion MG should not use the device. •...
  • Page 8 CONVENTIONS USED IN THIS USER MANUAL NOTE Notes provide additional important information. Tips indicate helpful information for using the Relivion MG. WARNING! Warnings indicate conditions or practices that may result in damage to the equipment or minor/moderate injury to the...

  • Page 9: Table Of Contents

    1.2 THE RELIVION MG KIT ..................... 11 1.3 RELIVION® MG DEVICE ....................12 2 GETTING READY ....................13 STEP 1. CHARGING THE RELIVION MG ..................13 STEP 2. ADJUSTING THE RELIVION MG DEVICE TO FIT YOUR HEAD ........16 ®...

  • Page 10: Introducing Revilion® Mg

    INTRODUCING REVILION® MG This chapter introduces the Relivion MG device and describes its components and its package contents. To ensure safe and proper usage, you should review this entire user manual carefully before using the Relivion MG NOTE device. Contact Neurolief customer support at support@relivion-medical.com...

  • Page 11: The Relivion Mg Kit

    Even though the Relivion MG device can be fully operated and used without this mobile app, it is highly recommended to use it because of its benefits, described on page 21. The Relivion MG device communicates with the Relivion MG mobile app on the patient’s mobile smartphone via a Bluetooth link.

  • Page 12: Relivion® Mg Device

    1.3 RELIVION® MG DEVICE The Relivion MG device can be comfortably worn on the head during treatment. It integrates six electrodes – four at the front of the device (forehead) and two at the back (occiput). It includes two flexible arms that go under the hair while the device is worn.

  • Page 13: Getting Ready

    • STEP 2. ADJUSTING THE RELIVION MG TO FIT YOUR HEAD • STEP 3. USING THE RELIVION MG APPLICATION It is highly recommended to perform the Relivion MG initial fitting and practice treatment prior to having a migraine attack. STEP 1. CHARGING THE RELIVION MG It is recommended to fully charge the Relivion MG device before first use and after each subsequent use, in order to ensure that it is always ready when needed.
  • Page 14 Figure 5: Relivion® MG Charger Cable and Power Supply Connect the magnetic connector of the charging cable to the charging socket on the Relivion MG. The charging socket is located on the bottom of the Relivion MG device as shown below.
  • Page 15 When the Relivion MG device is disconnected from the charger, it turns off. Figure 8: Status Indicator Light on the Relivion MG NOTE It is not possible to use the Relivion MG while it is connected to the charger.

  • Page 16: Step 2. Adjusting The Relivion Mg Device To Fit Your Head

    Insert the electrode pads, as described below Relivion MG comes with 13 sets of electrode pads. Each set includes six electrode pads to be placed on top of the electrodes in the device. Each set of electrode pads is provided in a separate packet.
  • Page 17 NOTE It will take a few tries until you find the right size for your device, but this step is only required once, before using the Relivion MG for the first time. The size of the Relivion MG device arms is determined by the numbers located on each arm.
  • Page 18 NOTE Be sure to place the arms of the Relivion MG device under your hair. If the Relivion MG size fits your head, the magnet ends should connect (you might need to apply some pressure). Figure 14: Magnet ends meet at the back of your head...
  • Page 19 Neurolief Relivion ® MG User Manual If the magnets do not connect, remove the device and lengthen both arms by 1 unit size. To lengthen each arm, press the size adjustment release button and extend the arm, as shown below -...
  • Page 20 The front of the device is placed as close as possible to your eyebrows without covering them. • The arms of the Relivion MG are above your ears and not over them. • The magnet ends rest above the bump of the occipital bone at the back of your head.

  • Page 21: Step 3. Using The Relivion Mg Application

    Track your migraine occurrences and treatments performed through the migraines report summary. • The Relivion MG app does not control the Relivion MG device. The device is controlled by pressing the buttons on it, as described on page 30. NOTE •...
  • Page 22 Neurolief support. If you have not yet acquired a Relivion MG device, you can still launch the Relivion MG mobile app, and go through the onboarding (registration) process. You will not be able to start manually recording information about your migraines using the app’s Migraine Diary Follow-Up features.
  • Page 23 Android 7 and above. NOTE The Relivion MG device provides sufficient Quality of Service (QoS) across its BLE internal network for its indication of use. The Relivion MG BLE internal network utilizes encryption of the data that is being transferred.
  • Page 24 MG mobile app. Tap the Sign Up button and then follow the displayed instructions to ® create your Relivion MG app account and to pair the app with the Relivion MG device. Instructions for using the Relivion MG device are displayed.
  • Page 25 MG User Manual Figure 20: Relivion® MG Device Pairing Screen A Neurolief support representative will be in touch with you by phone in order to activate your Relivion MG app account so that it can communicate with the Relivion MG device.
  • Page 26 As part of performing the initial fitting while using the mobile app, you will be asked to allow access to your camera. This will help you to see how the Relivion MG is positioned on your head, just like looking in a mirror.
  • Page 27 MG User Manual USING THE RELIVION MG APP ® After the Relivion MG mobile app is ready to use and connected to the Relivion MG device, you’ll see the following screen: Figure 23: Home Screen NOTE The Relivion MG app does not control the Relivion MG device.
  • Page 28 MG app can be used to guide you through your treatment. ® NOTE The Relivion MG app does not activate treatment on the Relivion MG device. This can only be done manually on the Relivion MG device. To start a treatment –...
  • Page 29 MG app on your ® smartphone and the Relivion MG device, as well as the battery charge status and the Bluetooth connection. These are the indications you’ll see when your Relivion MG device is connected, fully charged and the Bluetooth is connected: Figure 24: Indications bar –...

  • Page 30: Using The Relivion® Mg Device

    MG system. OPERATING BUTTONS AND INDICATORS • STEP 1. PREPARING FOR TREATMENT • STEP 2. PERFORMING TREATMENT • OPERATING BUTTONS AND INDICATORS Figure 26 shows the Relivion MG device operating buttons and indicators. Figure 26: Relivion® MG Operating Buttons and Indicators...
  • Page 31 Neurolief Relivion ® MG User Manual Table 2 describes the function of each button and indicator on the front interface of the Relivion MG. Table 2: Relivion MG User Interface Functions Indicator Description Function Light Press once to turn the device ON.
  • Page 32 Neurolief Relivion ® MG User Manual The Relivion MG also emits sounds (beeps) to indicate its status. Table 4: Relivion MG Sound Indications Sound Description Button Press (Short Beep) The device beeps whenever any button is pressed. Minimum/Maximum You’ll hear this sound whenever you try to go below the Intensity minimum or above the maximum device intensity.

  • Page 33: Step 1. Preparing For Treatment

    Relivion MG using the buttons on the device. TO PREPARE FOR TREATMENT – Turn the Relivion MG device ON by pressing the Main button. The device beeps and the device status indicator is steady blue. Figure 27: Turning ON the Device On the mobile App, press the Start Wizard button and answer the guided questions.
  • Page 34 MG device on your head. Spread the device arms and place the magnet ends at the ® sides of your head (above your ears). Push the Relivion MG backward so that the arms go under your hair, ensuring that the magnets constantly press against your scalp and connect at the back of your head.
  • Page 35 The arms of the Relivion MG are above your ears and not over them. • The magnet ends of the Relivion MG rest above the bump of the occipital bone at the back of your head. Figure 32: Proper Placement of the Relivion MG...
  • Page 36 Neurolief Relivion ® MG User Manual Press on the back electrode covers (see Figures 34 and 35) until you feel moisture on your scalp. Figure 34: Pressing the Back Electrode Covers on the Head Figure 35: Back Electrode Covers...
  • Page 37 Neurolief Relivion ® MG User Manual Figure 36: Pressing the Back Electrode Covers (Mobile App)

  • Page 38: Step 2. Performing Treatment

    MG device. ® Although it is not mandatory, it is highly recommended to use the Relivion MG app to describe and report your migraines. The information you provide before and after the treatment can help your physician review and recommend your treatment regimen.
  • Page 39 Neurolief Relivion ® MG User Manual Figure 38: Initiating Treatment (Mobile App) Figure 39: Treatment Display Screen When using the app, after initiating the treatment, you’ll see a screen showing the treatment time and the intensity level indicator.
  • Page 40 NOTE If you need to stop the treatment before it automatically ends, press the Main button. The Relivion MG will beep and turn off. To remove the device, gently pull open the Relivion MG arms and remove the device from your head.

  • Page 41: Using The Application

    Neurolief Relivion ® MG User Manual USING THE APPLICATION MIGRAINE DIARY The app allows you to track your migraines and treatments. Treatments that are handled with the mobile app, including your answers to the questions before and after treatment, are automatically added to your Migraine Diary.

  • Page 42: Migraine Report Summary

    Neurolief Relivion ® MG User Manual MIGRAINE REPORT SUMMARY The app shows you some statistics on your migraines. Details that are shown are: • The total number of headache days you had per month over the last six months. •...

  • Page 43: Messages

    MG User Manual MESSAGES The app displays messages that you may get from your physician, Neurolief customer support and/or system messages. On the Messages page, you’ll see a list of messages. Each message has a title, message content and a date. You can identify read messages vs. unread ones and delete messages. Once there are unread messages, an icon appears next to the Messages icon in the app menu.

  • Page 44: More

    MG User Manual MORE Under the “More” menu option, you will find further information about your Relivion MG device and app. Under “Legal,” you will find the Privacy Policy and the User Agreement. For your convenience, this User manual and the initial fitting training can be found under the “How to Use”...

  • Page 45: Troubleshooting And Maintenance

    This series of beeps indicates interrupted electrode contact. When the electrode is not in proper contact with your head, the status indicator light flashes red and the Relivion MG beeps. The red light will keep flashing until the electrode contact is fixed. If you are using the I initiated the treatment, heard app, it indicates which electrodes have interrupted contact.
  • Page 46 The Relivion MG device does The battery is depleted. Charge your Relivion MG device, as described ® not turn ON. in Step 1, Charging the Relivion MG section on page 13.

  • Page 47: Cleaning And Maintenance

    Make sure Bluetooth is turned on in your smartphone settings. Make sure you correctly entered the last 3 digits of the Serial Number of your Relivion MG (the S/N label is located on the lower front side of the device, next to the nose bridge).

  • Page 48: Techincal Specifications

    Neurolief Relivion ® MG User Manual TECHINCAL SPECIFICATIONS This chapter describes the technical specifications of the Relivion® MG. Table 6: Technical Specifications Operating Conditions Temperature +41°F to +104°F/+5°C to +40°C Relative Humidity 15% to 90% Atmospheric Pressure 10.1PSI to 15.3 PSI/700 hPa to 1060 hPa...
  • Page 49 Neurolief Relivion ® MG User Manual Maximum Current Density (mA/In 12.45 front electrodes/17.93 back electrodes/ 1.93 front r.m.s.)/ (mA/cm , r.m.s.) electrodes/2.78 back electrodes Maximum Average Power Density 0.000077 front electrodes/0.000219 back electrodes/ (W/In )/ (W/cm 0.000012 front electrodes/0.000034 back electrodes Maximum Rise Time ≤5 µsec...

  • Page 50: Aelectromagnetic Compatibility

    Table 7: Manufacturer's Declaration – Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment – Guidance The Relivion MG uses RF energy only for its internal function. Therefore, its RF emissions are very low and RF Emissions CISPR 11 Group1 Class B are not likely to cause any interference in nearby electronic equipment.
  • Page 51 Neurolief Relivion ® MG User Manual Table 8: Manufacturer's Declaration – Electromagnetic Immunity Electromagnetic Environment – Immunity Test IEC 60601 Test Level Compliance Level Guidance Floors should be wood, concrete, or Electrostatic 8kV contact 8kV contact ceramic tile. If floors are covered...
  • Page 52 Neurolief Relivion ® MG User Manual Electromagnetic Environment – Immunity Test IEC 60601 Test Level Compliance Level Guidance Power frequency Power frequency magnetic fields (50/60 Hz) magnetic should be at levels characteristic of 30 (A/m) 30 (A/m) field a typical location in a typical commercial or hospital environment.

  • Page 53: Electromagnetic Compatibility Warnings

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Relivion MG device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this...

  • Page 54: Bfcc Compliance

    FCC COMPLIANCE This device complies with Part 15 of the FCC Rules. Operation is subject to the following conditions – This device may not cause harmful intessrference. This device must accept any interference received, including interference that may cause undesired operation.
  • Page 55 Contact our customer support team at +1-888-4Relivion (888-473-5484) Or visit our website at www.Relivion.com Neurolief Inc. 1505 West Cleveland Street, Ste 200, Tampa, FL 33606, USA Neurolief Ltd. 12 Giborei Israel, Netanya, Israel. MAN1001A Rev.6 (for model type RLV3) 1 Jan 2022...

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