THERANICA Nerivio User Manual Download Page 1

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Nerivio

A wireless non-invasive neuromodulation
device for the acute treatment of migraine

USER MANUAL

™

Summary of Contents for Nerivio

Page 1: ...Nerivio A wireless non invasive neuromodulation device for the acute treatment of migraine USER MANUAL...

Page 2: ...ced 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...

Page 3: ...ce 25 7 2 Disposal 26 8 Troubleshooting 26 8 1 General 26 8 2 Main errors and messages 27 8 3 LED status 28 8 4 Customer support 28 9 Operation specification 29 9 1 Environment operating conditions 29...

Page 4: ...roduces electrical signals The device is good for 12 treatments of 45 minutes 2 Armband and an extension The armband should be wrapped around the device on the arm to improve the contact between the d...

Page 5: ...tion on the arm and to conceal the device to enable a discreet treatment An extension is also provided for larger arm sizes An application app installed on a smartphone to control and monitor the trea...

Page 6: ...mpliance with FCC Federal Communications Commission Class B certified for home use FCC identifier 2AOH8 NM Manufacturer Type BF applied part IEC60601 1 Catalog number Serial number IP22 Ingress protec...

Page 7: ...t 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...

Page 8: ...could cause electric shock electrical interference or serious injuries or medical conditions 4 2 WARNINGS PRECAUTIONS AND ADVERSE EVENTS The following icons are used throughout this user manual Warni...

Page 9: ...to cancerous lesions Do not use the device on an arm with a metallic implant In such cases consider using it on the other upper arm Do not use the device simultaneously with another electrical stimul...

Page 10: ...ty may occur in the vicinity of equipment emitting RF e g microwave routers Wi Fi devices To minimize moisture loss when unused the electrodes should be covered with the provided protective film and t...

Page 11: ...ng numbness in the arm pain in the arm or redness of the skin which should disappear shortly after the end of the treatment Refer to Theranica s website at https theranica com for a complete listing o...

Page 12: ...hone requirements Step 2 Download and install the Nerivio app via Google play or App store depending on your operating system Step 3 You will be asked to create an account Follow the app instructions...

Page 13: ...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 registere...

Page 14: ...o device to the app using the app instructions The device and the smartphone should be in proximity of less than 1 inch 2 5 cm As you begin using the app it may ask for permissions Please allow these...

Page 15: ...e 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...

Page 16: ...s and migraine headaches More screen This screen provides access to some of the technical aspects of the app View profile Select this to view your account details Buy Nerivio Select this to but a Neri...

Page 17: ...lect to enter a code if applicable Sign out select this to sign out of your account 6 2 TREATING A MIGRAINE HEADACHE The treatment should be performed at the onset of a migraine headache For effective...

Page 18: ...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 succes...

Page 19: ...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 Adjust the armband to your size There are 4 sizes you can choose...

Page 20: ...s now begun and will stop automatically after 45 minutes A slow flashing mostly off green light indicates the device is stimulating Do not start a treatment before placing the device on your arm Do no...

Page 21: ...tarts at a default intensity of 12 Gradually increase the intensity as described below Setting intensity level a Start increasing the stimulation intensity using the button Each press will increase th...

Page 22: ...ntact 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 intensi...

Page 23: ...adual increase will be presented in the app by a flashing increasing indication that will stop once the desired intensity is reached The treatment can be stopped early at any time by touching the paus...

Page 24: ...has ended the green light will turn off Step 2 Apply the protective film on the electrodes the protective film is reusable Step 3 Place the device in its original package or in the travel bag to store...

Page 25: ...unt details To view your login details in the app touch More and then touch View profile 7 CLEANING MAINTENANCE AND DISPOSAL 7 1 CLEANING AND MAINTENANCE The device can be cleaned with a dry cloth exc...

Page 26: ...ease check and confirm 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...

Page 27: ...e phone Enable the Bluetooth feature on your phone and try to reconnect 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 au...

Page 28: ...ice 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 inch 2 5 cm Authentication failed The device has already been associat...

Page 29: ...DITIONS Operating temperature range 5 to 40 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...

Page 30: ...charge 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 mo...

Page 31: ...play 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 O...

Page 32: ...further control However the app may not enable you to stop the treatment or adjust the intensity which may result in an uncomfortable feeling If such sensation occurs please remove the device from yo...

Page 33: ...h it is used Do not use devices which generate strong electrical or electromagnetic fields in proximity to the Nerivio device This may result in incorrect operation of the device and create a potentia...

Page 34: ...ormatted based on IEC60601 1 2 2007 Electromagnetic emissions IEC 60601 1 2 Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The Nerivio uses RF energy only...

Page 35: ...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...

Page 36: ...oadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field...

Page 37: ...mful interference to radio communications However there is no guarantee that interference will not occur in a installation If this equipment causes interference with other devices which may be determi...

Page 38: ...safety and essential performance IEC EN 60601 1 2 edition 4 0 Medical electrical equipment Part 1 2 General requirements for safety collateral standard Electromagnetic compatibility Requirements and t...

Page 39: ...ca 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 1 1 Rev...

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