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Manufacturer  

Neurolie

f Relivion™ User Manual

 

 

Important Notice 

Copyright © 2018 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. 

Any software described in this publication is furnished under a license agreement. 

All other trademarks are the property of their respective owners. Other company and 
brand products and service names are trademarks or registered trademarks of their 
respective holders. 

Manufacturer 

Neurolief Ltd. 
12 Giborei Israel 
Netanya, Israel 
4250412  
Tel 

 +972-9-3730288  

Email 

 [email protected] 

Rx Only 

Federal (USA) law restricts this device to sale by or on the order of a physician or with 
the descriptive designation of any other practitioner licensed by the law of the state 
in which he/she practices to use or order the use of the device. 

Intended Use 

The Relivion

 transcutaneous electrical nerve stimulator is intended for the treatment 

of headache and is indicated for the acute treatment of migraine with or without 
aura in patients 18 years of age or older. It is a prescription device to be self-used at 
home.  

Summary of Contents for Relivion

Page 1: ...Neurolief Relivion User Manual Relivion User Manual...

Page 2: ...roducts and service names are trademarks or registered trademarks of their respective holders Manufacturer Neurolief Ltd 12 Giborei Israel Netanya Israel 4250412 Tel 972 9 3730288 Email support neurol...

Page 3: ...apter 3 Using the Device page 21 describes how to prepare connect and use the Relivion Chapter 4 Troubleshooting and Maintenance page 33 describes how to troubleshoot and clean the Relivion Chapter 5...

Page 4: ...from limited dust ingress and from water spray from any direction RF transmitter Waste Electrical and Electronic Equipment Directive WEEE Safety Information The following section provides important s...

Page 5: ...r low temperatures or humidity Use within the temperature and humidity range according to the product s specifications see Table 7 Do not use a device that shows signs of mechanical damage or loose pa...

Page 6: ...r around the electrodes Skin redness usually disappears within several hours after treatment Sleepiness fatigue or sleep disorders Sedative effect during or after treatment Dizziness during or after t...

Page 7: ...AD 15 2 3 STEP 3 GETTING STARTED WITH THE RELIVION APP 19 Chapter 3 Using the Device 21 3 1 OPERATING BUTTONS AND INDICATORS 21 3 2 STEP 1 PREPARING FOR TREATMENT 23 3 3 STEP 2 PERFORMING TREATMENT 29...

Page 8: ...Table of Contents Neurolief Relivion User Manual 8 Blank page for double sided printing...

Page 9: ...using the Relivion device Contact Neurolief customer support at 972 9 3730288 or visit the Neurolief website at www neurolief com if you have any questions 1 1 WHAT IS THE NEUROLIEF RELIVION The Reli...

Page 10: ...e greater Occipital nerve The Relivion incorporates an on board user interface that enables the user to activate deactivate the device and to adjust the stimulation intensity It provides visual and au...

Page 11: ...ce forehead and two in the back occiput It includes two flexible arms that go under hair layers while the headset is worn A simple user interface and a nose bridge are located at the frontal aspect of...

Page 12: ...Introducing Relivion Neurolief Relivion User Manual 12 Blank page for double sided printing...

Page 13: ...ways ready when needed It takes approximately three hours to fully charge the battery When the battery is low the battery indicator light blinks yellow After the device is fully charged it is typicall...

Page 14: ...nnector connects using magnetic force It must be connected in the proper direction for the magnet s polarity to work properly Figure 5 Charging Socket Location Figure 6 The Magnetic Connector Connecte...

Page 15: ...nly need to make these adjustments once before using the Relivion for the first time To adjust the Relivion to fit your head 1 Insert the electrode pads as described below The device is provided with...

Page 16: ...e only electrode pads provided by the manufacturer 2 Adjust the arms of the headset to fit as tightly as possible on the head The arms of the device are set to size 5 before the device is shipped You...

Page 17: ...e Device Backwards on your Head NOTE Be sure to place the device arms under your hair Check to see if the magnets at the ends of each arm meet at the back of your head You should hear a click when the...

Page 18: ...Make sure that the headset fits snugly and that the magnets of both arms meet on the back of the head If the magnets do not meet at the back of the head you must extend the arms to make them longer T...

Page 19: ...obtain a tight fit It may take more than one attempt to get the arm length to be identical for both arms while obtaining a tight fit Figure 15 Size Adjustment Scale 2 3 STEP 3 GETTING STARTED WITH THE...

Page 20: ...Getting Ready Neurolief Relivion User Manual 20 Blank page for double sided printing...

Page 21: ...g Buttons and Indicators Table 3 Relivion User Interface Functions Indicator Light Description Function Main button First Press The device is ON Second Press The device is OFF Intensity adjustment but...

Page 22: ...t the Main button has been pressed and the device is in standby mode Flashing Blue Treatment stimulation is active Flashing Yellow Low battery Steady Red Indicates a device malfunction Flashing Red In...

Page 23: ...with the procedure it is recommended to use the mobile app NOTE The mobile app displays the device status and indications but does not control the Relivion You control the Relivion using the buttons...

Page 24: ...ollow the on screen instructions to log in to the mobile app and register your device Figure 18 Login Screen Figure 19 Device Registration Screen Note that the image on the Registration screen indicat...

Page 25: ...r should be illuminated on the app Figure 20 Successful Connection 4 Tap the Press to Start button on the mobile application 5 Remove all hair clips and hair ties Also remove your glasses 6 Clean your...

Page 26: ...es and 16 times for each pad on the two back electrodes Be sure to wet the entire surface of each electrode pad Figure 22 Wetting the Electrode Pads Figure 23 Wetting the Electrode Pads Mobile App NOT...

Page 27: ...arms penetrate under your hair and lock to each other by the magnets You should hear a click when the magnets meet Figure 24 Placing the Device on the Head Figure 25 Placing the Device on the Head Mob...

Page 28: ...ment of Front Part of the Device When performing this step with the mobile app you can click the Camera icon on your app to view the position of the headset on your head like when looking into a mirro...

Page 29: ...atment using the Relivion device NOTE It is not mandatory to use the mobile app to perform treatment To perform treatment 1 To initiate treatment press the button on the Relivion The indicator light b...

Page 30: ...Using the Device Neurolief Relivion User Manual 30 Figure 31 Initiating Treatment Mobile App...

Page 31: ...mulation is weakening This is a result of becoming accustomed to the stimulation If so further increase the stimulation intensity to the maximum tolerable level in order to maximize the therapeutic ef...

Page 32: ...Using the Device Neurolief Relivion User Manual 32 Blank page for double sided printing...

Page 33: ...blem occur that is not covered below or that cannot be resolved by the suggested solutions below contact customer support Table 6 Relivion System Troubleshooting Problem Symptom Description I initiate...

Page 34: ...ress the button to start treatment Figure 33 Faulty Electrode Contact Back Electrodes If you are not using the app press the water release covers on the rear side of the electrodes at the back of the...

Page 35: ...no parts that need regular service or maintenance Clean the device with a wet cloth after each use Do not use solvents of any kind acetone petrolatum and so on on the device Replace the electrode pads...

Page 36: ...Troubleshooting and Maintenance Neurolief Relivion User Manual 36 Blank page for double sided printing...

Page 37: ...al Specifications Number of Stimulation Channels 3 2 Trigeminal 1 Occipital Constant Current Yes Waveform Symmetrical rectangular biphasic pulse 100 compensated Maximum Current Trigeminal 6 mA per cha...

Page 38: ...r Input 100 240 VAC 50 60 Hz 0 3 A Radio Transceiver Properties Frequency Band 2 400 2 483 5 MHz Maximum Emitted Radiation Power 7 5dBm Modulation GFSK Radio Protocol BLE type 4 1 Headset Number of El...

Page 39: ...PR 11 Group1 Class B The Relivion 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 Clas...

Page 40: ...t burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Evaluated during AC DC adapter approval Mains power quality should be that of a typical domestic establishment Fast Surge...

Page 41: ...V from 0 15 to 80 MHz and 80 AM at 1 kHz 10 V m from 80 MHz to 2 7 GHz Portable and mobile RF communications equipment should be used no closer to any part of the ME EQUIPMENT or ME SYSTEM including c...

Page 42: ...may impair Relivion essential performance and incorrect output that exceeds the device s specifications may occur Use of this device adjacent to or stacked with other equipment should be avoided beca...

Page 43: ...15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in residential installations This equipment generates uses and can radiate radio frequency e...

Page 44: ...44 Neurolief Ltd 12 Giborei Israel Netanya Israel Tel 972 9 3730288 MAN1001A Rev 1 1 for model type RLV3...

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