Related Manuals for THERANICA Nerivio Infinity
Summary of Contents for THERANICA Nerivio Infinity
- Page 1 A wireless non-invasive rechargeable neuromodulation device for treatment of migraine USER MANUAL LBL-INF-0220-2.0 Version 2.0 September 2024...
- Page 2 © 2022-2024 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.
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Page 3: Table Of Contents
Table of content 1. Introduction 1.1. About this manual 1.2. Product overview 1.3. Product functions 1.4. Package content 2. Glossary 3. Labels and symbols 4. Safety 4.1. Conditions for use 4.2. Warnings, precautions and Adverse Events 5. What does the treatment feel like? 6. - Page 4 16. FCC radio frequency interference statement 17. Applicable standards Page |...
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Page 5: Introduction
6. Nerivio mobile application (app) that can be downloaded from your app store The external side of the Nerivio Infinity device includes a power button and two-color LED indicator that signals various modes of operation. The internal side includes magnetic connectors to the electrodes that deliver neurostimulation signals. -
Page 6: Product Functions
also provides notifications and indications on the connection status and on the remaining battery charge level. It also offers a migraine dairy feature which enables to track information about your migraine attacks. 1.3. PRODUCT FUNCTIONS • The device is battery-powered; the battery is internal, integrated, and rechargeable. •... -
Page 7: Glossary
• REN: Remote electrical neuromodulation • NFC: Near filed communication, this technology allows for wireless communication between devices when they are in proximity. For the Nerivio Infinity device, NFC is used to authenticate the electrode pad, ensuring that only authorized electrode pads are used with the Nerivio Infinity device. - Page 8 Symbol Description Manufacturer information and manufacturing date YYYY-MM-DD Country code (IL) and date of manufacture YYYY-MM-DD Type BF applied part (IEC60601-1) Catalog number Serial number Ingress protection rating Use by date - indicates the date after which the device is not to be used Keep dry Temperature limits Humidity limitation...
- Page 9 Symbol Description 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.
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Page 10: Safety
4.1. CONDITIONS FOR USE 4.1.1. INDICATION FOR USE The Nerivio Infinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 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 for acute treatment, or every other day for preventive treatment. - Page 11 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, immerse in water, crush, expose to a violent vibration, incinerate, over-charge, overheat or short-circuit the battery or the device.
- Page 12 Do not use the device in a magnetic resonance imaging (MRI) environment The long-term effects of chronic use of the device are unknown The device has not been evaluated for use in pregnant women and people less than 12 years of age The device has not been evaluated for use in people with congestive heart failure (CHF), severe cardiac or cerebrovascular disease Do not use the electrodes past expiration date and recommended number of uses...
- Page 13 The device should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, the Nerivio Infinity 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 Infinity device.
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Page 14: What Does The Treatment Feel Like
5. WHAT DOES THE TREATMENT FEEL LIKE? The device transmits electrical pulses. You may feel a strong sensation at first, but it will typically fade to a comfortable level after a couple of seconds. You will then need to set the treatment intensity level by increasing it to the highest level that feels strong yet comfortable and not painful (see instructions below). - Page 15 policy (the EULA). The EULA confirmation is only required when the app is opened for the first time or when the EULA was changed. For safety reasons, you are advised to lock your smartphone with a password or any other means (biometric, etc.). If this is the first time you are using the app, you will need to create an account in the "Sign up"...
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Page 16: Charging The Device
It is possible to open an account for an adolescent, but the process needs to be initiated by an adult caregiver, in the following manner: 1. Create your Adult account by using the process above. 2. After logging in, go to Account Settings (under More menu) to add create an Adolescent account. - Page 17 When connected, LED indications are as follows – Red light: Charging in progress Green light: Charge is complete, battery is full A full charge cycle will typically take 3.5-4 hours. However, a 30-minute charge will bring the battery level to a sufficient level for at least one treatment. The Nerivio mobile application can be used to check the remaining battery charge.
- Page 18 Step 2: Enable Bluetooth on your smartphone. Before you begin, make sure the device is charged. Then, open the mobile app, turn on the device, and connect the Nerivio Infinity device to the app using the app instructions. The device and the smartphone should be in proximity of 1 inch (~2.5 cm) or less.
- Page 19 Step 3: The instructions of how to treat a migraine headache with Nerivio Infinity will be presented. You can skip it by pressing “Skip” or “Next”. Note: There are two armband extensions included in the package, allowing you to adjust the armband length to fit all arm sizes comfortably.
- Page 20 From left to right: A) The GIER UP! button is located at the top-right corner of the treatment screen and is enabled a few seconds after the treatment starts. B) GIER welcome screen (shown 3 times only) provides the entry point to the GIER library.
- Page 21 It provides information on how well you adhere to the recommended instructions of Nerivio Infinity such as treating early. MyAnalytics presents whether your treatments with Nerivio Infinity were helpful for your headaches and other symptoms and provides information on the types of medications you use. It displays the distribution of your migraines across the weekdays and time in the day (e.g., mornings).
- Page 22 • About- select this to view the app version and the connected device info. • Tell us how you feel about Nerivio Infinity - select this to rate and share with us your feedback on the Nerivio Infinity device.
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Page 23: Treating A Migraine Headache
6.2. TREATING A MIGRAINE HEADACHE The acute treatment should be performed at the onset of a migraine headache. 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). - Page 24 Step 1: Check the electrodes pad kit expiration date and recommended number of treatments, you can find this information on the label located on the electrode’s protective film and on the electrodes pad kit package. Do not use the electrodes pad kit past expiration date or after recommended number of uses Step 2: Make sure that your arm skin is clean, dry and free from lotion.
- Page 25 Step 5: Sync the electrodes to the app via NFC – Make sure NFC is enabled on your device (to enable NFC on Android, open Settings, open Connections or Connected Devices [depending on your device], then open NFC or NFC and payment, and toggle NFC on. For iOS [iPhone 7 and later], NFC is enabled by default and does not require manual activation.
- Page 26 ground, so that fastening armband with a device around the arm will not displace the device. Step 8: Place the device into the armband by snapping it into the inner circle and adjust the armband to your size. The Extensions allow you to adjust the armband to your perfect arm size.
- Page 27 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 It is important to use the device only when positioned correctly on the arm. The device should be located midway between the elbow and the shoulder, on the outer side of the arm and horizontally to the ground.
- Page 28 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. Setting intensity level: a) Start increasing the stimulation intensity using the "+" button. Each press will increase the intensity by 1 unit.
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Page 29: Treatment In Progress
Step 12: After the treatment has begun, questions regarding your migraine symptoms will be automatically displayed. You can record your migraine symptoms or skip this by touching “Next”. Note that the treatment is still in progress, and it can still be controlled by the app. You can also record your post-treatment outcomes via notifications that will be sent to you or in the post-treatment assessment section in the More menu. - Page 30 During the treatment, you may press the GIER (Guided Intervention of Education and Relaxation) button at the top-right of the screen, to view and listen to a guided video explaining the treatment, which may assist you coping with the migraine attack. During the treatment, you may experience slight muscle spasm, numbness of the hand and irritation of the skin.
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Page 31: Storing The Device For Next Use
Step 3: Place the device in its original package or in the travel pouch to store it for the next use. Place the electrodes in their foil wrapper. Step 4: Close the app. If after acute treatment your migraine headache is not aborted 30 minutes following the treatment, you may administer additional acute treatments. -
Page 32: Performing Over-The-Air (Ota) Software Update
6.5. PERFORMING OVER-THE-AIR (OTA) SOFTWARE UPDATE To ensure running the latest software in the device for best performance and experience, Nerivio app may occasionally pop-up a notification that a software upgrade to the device is available. It is recommended to approve these updates. Such notifications will never pop-up during treatment, only during idle times. -
Page 33: Disposal
• To minimize moisture loss, when unused, the electrodes should be covered with 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 lifetime of the electrodes varies depending on skin conditions, skin preparation, storage and climate. -
Page 34: General
The power button was not Press the power button continuously for 2- held long enough 3 seconds The device does Nerivio Infinity has automatic If the charger is connected, disconnect the not turn off shut off features charger In case the device cannot turn off and the •... - Page 35 3. If the device does not connect go to the More menu at the bottom of the Nerivio App, select Nerivio Infinity device and then select Connect a new Nerivio Infinity device. 4. If you still cannot pair, do a total shutdown of your phone, restart your phone and try to pair.
- Page 36 4. If the device does not connect go to the More menu at the bottom of the Nerivio App, select Nerivio Infinity device and then select Connect a new Nerivio Infinity device. If you still cannot pair, rest network settings...
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Page 37: Main Errors And Messages
Errors and messages What it may mean What to do displayed on the screen Nerivio Infinity is not properly The device is not properly Make sure the protective film placed. Make sure that the placed on the arm and/or the... -
Page 38: Customer Support
The Nerivio Infinity is a durable medical equipment with replacable electrodes. The service lifetime expectancy of the Nerivio Infinity in typical use mode of about 18 treatments per month and under recommended operational use and storage conditions is 3 years. -
Page 39: Environmental Trasnportation And Storage Conditions
9.3. ENVIRONMENTAL TRASNPORTATION AND STORAGE CONDITIONS Temperature range: +10º to +27º C (50'F-80.6'F) Relative humidity range: 40%-60%, with no condensing Atmospheric pressure: 70-106 kPa 9.4. ELECTRICAL PROPERTIES Battery type: Rechargeable Li-Ion cell 3.7V 400mAh 1.48Wh Maximum Battery Voltage: 4.2V Maximum device output Current 40mA Device output Frequency 100-120Hz... - Page 40 2KΩ 30mA 10KΩ Maximum phase charge 8 µC 500Ω Maximum average current 1.76mA 500Ω Maximum current density 1.6 mA/cm² (peak) 500Ω Maximum current density 0.34 mA/cm² (r.m.s) 500Ω Maximum average current 0.07 mA/cm² density (abs value) 500Ω Maximum average power 1.41mW/cm²...
- Page 41 The device should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, the Nerivio Infinity should be observed to verify normal operation in the configuration in which it will be used...
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Page 42: Smartphone Requirements
Services and operated by the company, and an application frontend (“Client”) hosted by the mobile application (the App) on the user’s smartphone. The Nerivio Infinity is a closed system, which does not allow installation of additional external components to Firmware, Client software or Backend software. -
Page 43: Potential Adverse Reactions
Instructions for CyberSecurity The following cybersecurity controls are recommended to increase security of the Client software and user’s mobile platform: • The mobile platform should require authenticated access via user credentials. You are advised to lock your smartphone with a password or any other means (e.g. biometric, pin code or other). -
Page 44: Emc Statement
• Do not use any unspecified accessories with the Nerivio Infinity device. This may result in increased emissions or decreased immunity of the device. • The Nerivio Infinity device should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the Nerivio Infinity device should be monitored to verify normal operation in the configuration in which it is used. -
Page 45: Electromagnetic Documentation Compliance
Section 5.2.2 Complies 15.2. ELECTROMAGNETIC EMISSIONS The Nerivio Infinity is intended for use in the electromagnetic environment specified below. Please ensure that the device is used according to these specifications. Note: the following tables is formatted based on IEC60601-1-2. Test... -
Page 46: Electromagnetic Immunity
15.3. ELECTROMAGNETIC IMMUNITY The Nerivio Infinity is intended for use in the electromagnetic environment specified below. Please ensure that the device is used according to these specifications. Test Test Standard Class/ Severity level result Immunity (IEC 60601-1-2 section 8.9 - 8.11 & IEC 60601-2-10 section 202) and (ETSI EN 301 489-1/ ETSI EN 301 489-17 sec.7.2) -
Page 47: Recommended Separation Distances
Recommended separation distance between portable and mobile RF communications equipment and the NM Nerivio Infinity is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or the users of Nerivio Infinity can help prevent... -
Page 48: Applicable Standards
expressly approved by the manufacturer could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. - Page 49 Theranica Bio-Electronics LTD. 4 Ha-Omanut St., Netanya 4250438, Israel Tel: +972-72-3909-763, Fax: +972-72-3909762 © 2022 Theranica Bio-Electronics LTD. All Rights Reserved. www.theranica.com ART No. LBL-INF-0220-2.0, Rev. 2.0 Sep 2024 Page |...
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