LENIRE CR-201 User manual

IFU-0002 V2.0

IFU-0002 Lenire User Manual Version 1.0 Page 1
Table of Contents
Using this Manual 2
Section A - General Information 3
Chapter 1 - Introduction 4
Chapter 2 - Intended Use 4
Chapter 3 - Contraindications 5
Chapter 4 - Risks Associated with Use 6
Chapter 5 - General Warnings 6
Chapter 6 - Product and Package Labelling 8
Section B - Using Lenire 11
Chapter 7 - Product Components & Accessories 12
Chapter 8 - Controls and Indicators 14
Chapter 9 - Controller port 19
Chapter 10 - Charging the Controller and Headphones 20
Chapter 11 - Device Setup 24
Chapter 12 - Tonguetip Setup 26
Chapter 13 - Starting and Controlling a Treatment Session 28
Chapter 14 - Treatment Guidelines 32
Section C - Care, Storage Maintenance and Disposal 33
Chapter 15 - Cleaning 34
Chapter 16 - Storage and Transport 35
Chapter 17 - Maintenance 37
Chapter 18 - Disposal 38
Section D - Troubleshooting 39
Chapter 19 - Frequently Asked Questions 40
Chapter 20 - Bluetooth Pairing / Un-Pairing 44
Chapter 21 - Servicing 46
Chapter 22 - Device Errors 46
Section E - Technical Information 47
Chapter 23 - Environmental Operating Conditions 48
Chapter 24 - Radio Frequency (RF) Specifications 48
Chapter 25 - Guidance and Declaration for Electromagnetic Compatibility 49
Chapter 26 - Materials in Direct Contact with Human Tissue 51
Chapter 27 - Declaration of Conformity Radio Equipment Directive 2014/53/EU 52
Section F - Customer Support Contact Details 53

IFU-0002 Lenire User Manual Version 1.0Page 2
Using this Manual
This manual is supplied with the Lenire system to provide you with
information on the product, treatment regime and instructions for its safe
and eective use. You should read and understand these instructions
before use.

IFU-0002 Lenire User Manual Version 1.0 Page 3
Section A -
General Information
This section outlines the general information relating to the Lenire system,
including important safety information.

IFU-0002 Lenire User Manual Version 1.0Page 4
Chapter 1 - Introduction
Lenire® is a medical device intended to reduce the symptoms of tinnitus. It
comprises a handheld Controller and a tonguetip® which, delivers gentle,
electrical stimulation to the tongue, and is used in conjunction with wireless
Headphones that deliver audio stimulation. A Charger is included that can
be used to charge both the Controller and the Headphones.
The audio and tongue stimulation are configured and calibrated to your
individual characteristics during the initial fitting procedure by a trained
clinician.
Chapter 2 - Intended Use
The Lenire device is intended to be used by tinnitus suerers of at least
18 years of age to alleviate the symptoms of chronic, subjective tinnitus.
It should be used for 30 to 60 minutes per day, every day, for at least
10 weeks, after which you may experience sustained alleviation of your
tinnitus symptoms.
The Lenire device can be used in the home environment after consultation
and fitting by a suitably qualified clinician.
Lenire is intended for prescription use only. Use by a person for whom
the device has not been configured may cause discomfort, or temporary
exacerbation of tinnitus loudness.