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LENIRE Tinnitus User Manual

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IFU-0026 V2.0
Neuromod Devices Ltd., Rainsford St., Dublin, D08 R2YP, Ireland.
www.neuromoddevices.com
DE
FR
IT
NL
Lenire-Tinnitus-Behandlungsystem. Benutzerhandbuch
Manuel de l’utilisateur Système de traitement des acouphènes
Lenire Manuale d’uso Lenire Tinnitus Treatment System
Lenire Tinnitus Behandelingssysteem. Gebruikershandleiding
Lenire Tinnitus Treatment System. User Manual

Table of Contents

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LENIRE Tinnitus Specifications

General IconGeneral
Device TypeTinnitus Treatment Device
HeadphonesIncluded
Product TypeMedical Device
ComponentsHeadphones, Tongue Stimulator
StimulationAuditory and electrical stimulation of the tongue
Treatment Duration12 weeks

Summary

Section A General Information

Chapter 1 - Introduction

Introduces the Lenire Tinnitus Treatment System and its components.

Chapter 2 - Intended Use

Details the purpose and target users for the Lenire device.

Chapter 3 - Contraindications

Lists conditions where the device should not be used.

Chapter 4 - Risks Associated with Use

Outlines potential risks and side effects of using the device.

Chapter 5 - General Warnings

Chapter 6 - Product and Package Labelling

Section B Using Lenire

Chapter 7 - Product Components & Accessories

Details all the components included in the Lenire device package.

Chapter 8 - Controls and Indicators

Explains the functions of the device's buttons and status lights.

Chapter 9 - Controller port

Chapter 10 - Charging the Controller and Headphones

Chapter 11 - Device Setup

Chapter 12 - Tonguetip Setup

Chapter 13 - Starting and Controlling a Treatment Session

Section C Care, Storage Maintenance and Disposal

Chapter 15 - Cleaning

Instructions for cleaning the different parts of the Lenire device.

Chapter 16 - Storage and Transport

Guidelines for properly storing and transporting the device.

Chapter 17 - Maintenance

Procedures for maintaining the device and checking its components.

Chapter 18 - Disposal

Information on how to dispose of the device at the end of its service life.

Section D Troubleshooting

Chapter 19 - Frequently Asked Questions

Addresses common issues and provides solutions for the Lenire device.

Chapter 20 - Bluetooth Pairing / Un-Pairing

Explains how to pair the Controller with the Headphones via Bluetooth.

Chapter 21 - Servicing

Information regarding servicing and repair of the device.

Chapter 22 - Device Errors

Details error indicators and what they mean for the device.

Section E Technical Information

Chapter 23 - Environmental Operating Conditions

Specifies the recommended environmental conditions for device operation.

Chapter 24 - Radio Frequency (RF) Specifications

Lists the technical specifications for the device's radio frequency module.

Chapter 25 - Guidance and Declaration for Electromagnetic Compatibility

Provides information on the device's electromagnetic compatibility.

Chapter 26 - Materials in Direct Contact with Human Tissue

Details the materials used in parts of the device in contact with the body.

Chapter 27 - Declaration of Conformity Radio Equipment Directive 2014/53/EU

Declares the device's compliance with EU radio equipment directives.

Section F Customer Support Contact Details

General Contact Details

Provides the main contact information for Neuromod Devices Limited.

Technical Support Contact Details

Offers specific contact channels for technical assistance and queries.