LENIRE Tinnitus User manual

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

IFU-0026 Lenire User Manual Version 2.0
Page 1
English page 2
Deutsch Seite 28
Français page 54
Italiano pagina 80
Nederlands bladzijde 106
Using this manual
This manual is supplied with the Lenire device 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.
Verwendung dieses Handbuchs
Diese Anleitung ist im Lieferumfang des Lenire-Systems enthalten. Sie enthält Informationen zu
dem Produkt und zur Behandlung sowie Anweisungen zur sicheren und eektiven Handhabung.
Diese Anweisungen sollten vor Gebrauch gelesen werden.
Utilisation de ce manuel
Le présent manuel contient des informations sur le dispositif Lenire avec lequel il est fourni,
sur le programme de traitement et sur l’utilisation sûre et ecace du produit. Assurez-vous
de lire et de comprendre ce mode d’emploi avant d’utiliser votre produit.
Utilizzo del presente manuale
Il presente manuale viene fornito insieme al dispositivo Lenire e contiene informazioni circa
il prodotto e il regime di trattamento nonché istruzioni per un utilizzo sicuro ed ecace.
Siprega di leggere e comprendere le presenti istruzioni prima dell’uso.
Deze handleiding gebruiken
Deze handleiding wordt bij het Lenire-apparaat meegeleverd om u te voorzien van
informatie over het product, de behandeling en instructies voor een veilig en eectief
gebruik. U moet deze instructies lezen en begrijpen vóór gebruik.

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

IFU-0026 Lenire User Manual Version 2.0
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Section A
General Information
This section outlines the general information relating to the Lenire device,
including important safety information.
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 congured and calibrated to your individual characteristics
during the initial tting 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 tting
by a suitably qualied clinician.
Lenire is intended for prescription use only. Use by a person for whom the device has not
been congured may cause discomfort, or temporary exacerbation of tinnitus loudness.
Chapter 3 - Contraindications
• You have a pacemaker, debrillator or any other active implantable device,
unless directed by a doctor.
• You are pregnant, unless directed by a doctor.
• You suer from epilepsy or any other condition that may result in loss of consciousness.
• You suer from any condition that causes impaired sensitivity of the tongue.
• You have lesions, sores, or inammation of the oral cavity, unless directed by a doctor.
• You are suering from any intermittent or chronic neuralgia in the head and neck area.
Chapter 4 - Risks Associated with Use
Potential risks associated with use of the Lenire device include
Caution! – Do not use the device if:
Contact between the Tonguetip and dental retainers or metal fillings may
cause temporary discomfort.

English
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Chapter 5 - General Warnings
There is a possibility that some people may experience a mild allergic
reaction to the materials in the device.
You may experience a mild numbing sensation or a discomfort on the
tongue during treatment. If this occurs, reduce the tongue stimulation.
If the symptoms persist, contact your clinician.
Use of the treatment may result in mild fluctuations in tinnitus symptoms,
such as tinnitus loudness.
Headaches may accompany use of the treatment device.
Do not use the Tonguetip when going to sleep or under the influence
of alcohol or other substances that cause drowsiness.
Keep the Tonguetip and Charger out of the reach of children, to avoid
possible choking and strangulation hazards.
To avoid the risk of cross-contamination, the Tonguetip should not be
shared with any other person, as it is a single-patient, multi-use device.
Do not use the Tonguetip if you have lesions, sores, or inflammation of the
oral cavity. Discontinue use of the device until symptoms have resolved.
Do not leave the device in the sun, near an open fire or on a radiator.
The use of rechargeable Lithium Ion batteries is very common and they
are generally considered safe to use. With any energy storage device, they
carry safety risks including overheating. Only use the Charger provided
with your device and always follow the instructions in this manual when
charging your Lenire device.
To avoid the risk of a burn do not puncture, crack or crush the Controller.
Do not attempt to replace the Lithium Ion battery in your Lenire device.
Do not use in conjunction with a hearing aid.

IFU-0026 Lenire User Manual Version 2.0
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Chapter 6 - Product and Package Labelling
The label on the Controller, the Tonguetip plug, Carry Case and the product packaging provide
important information. The meanings of the associated symbols are described below, and in the
context of the relevant sections throughout this User Manual.
Use-by date (year and month). This is the date after which the device should
no longer be used.
Do not use if the packaging is damaged or previously opened.
Consult the User Manual.
This symbol indicates the need for the user to consult the User Manual
for warnings and precautions associated with this medical device.
Manufacturer’s details (name and address) and date of manufacture
(year and month).
The device’s Serial Number, Model Number and Lot Number appears next to
these symbols. You will need these numbers if you call Customer Support for
assistance. See Section F for the manufacturer’s contact details.
Ingress Protection (IP) Rating: IP ratings describe how eectively an enclosure
is sealed.
IP22 rated equipment is protected from objects greater than 12mm in
diameter being inserted e.g. ngers, and against small amounts of vertically
dripping water.
Non-ionizing radiation.
This symbol appears next to the model number of the Charger which should
be used to charge the Controller.
This symbol signies that the device should not be disposed of as domestic
waste. This ensures compliance with the Battery Directive 2006/66/EC.
The logo for this product range (Lenire).

English
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This symbol (direct current) identies a charging port.
This symbol represents the Tonguetip.
The USB (Universal Serial Bus) symbol – this is the connection that is used
by the clinician when they congure your device.
This symbol indicates that the Tonguetip provides a high degree of protection
against electric shock (Type BF Applied Part).
Storage and transport temperature limits. The lower limit is indicated near the
lower horizontal line and the upper limit is indicated near the upper line.
Storage and transport humidity limits. The lower limit is indicated near the
lower horizontal line and the upper limit is indicated near the upper line.
Keep dry.
Fragile, handle with care.
This symbol, the CE Mark, signies compliance with applicable EU Directives.
The number (2797) is the Notied Body number for the British Standards
Institute (BSI), who approved Lenire for CE Marking.

IFU-0026 Lenire User Manual Version 2.0
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Controller
The Controller (Model Number CR-201) is used to
“control” the treatment session i.e. you can start, pause
and resume the treatment session, adjust the volume of
the sound, adjust the level of the tongue stimulation, and
turn the device on or o.
Tonguetip The Tonguetip (Model Number TP-101) is a device which
provides gentle, electrical stimulation to the tongue.
Charger
The Charger (XP Power model VEP08US05-XE0767
or ACM06US05W-XZ1663A) is used to charge the
Controller.
Carry Case
The Carry Case (Model Number CE-401) is a portable
case which can be used to store the Controller and
Tonguetip in-between uses.
7.1 - Headphones
Lenire must be used in conjunction with a set of Bluetooth Headphones. For best performance,
it is essential that you use the Headphones provided by your clinician at the time of purchase.
For more information and specific instructions on the Headphones supplied with your
Lenire Device, please visit www.lenire.com/product-support and download the Lenire
Headphone Handbook. A printed version can be requested by contacting Customer
Support (see Section F for details).
The Lenire device box also contains a Quick Start Guide which outlines
the basic steps needed to commence a treatment session.
Lenire is designed to work only with the Headphones listed
in the Lenire Headphone Handbook which can be found at
www.lenire.com/product-support.
Chapter 7 - Product Components & Accessories
In the Lenire device box, you will nd:
Section B
Using Lenire
This section describes the components, controls and indicators of Lenire
and outlines the steps required to prepare for and commence treatment.

English
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7.2 - Batteries
The Controller is powered by a 3.7V Lithium Ion battery. The battery is charged using the
supplied Charger. The Controller battery is pre-tted and is not intended to be replaced.
See Chapter 10 for instructions on charging the Controller and Headphones.
If there are any diculties charging the Controller or the Headphones, see the section on
Troubleshooting (see Section D) or contact Customer Support (see Section F).
Chapter 8 - Controls and Indicators
8.1 - Treatment Controls
There are three control buttons on the front of the Controller:
1. Power Button
Hold this button for 2 seconds to switch the device on.
Hold this button for 2 seconds to switch the device o.
2. Play Button
Press this button to start or resume the treatment session.
3. Pause Button
Press this button to pause the treatment session.
Play Button Power Button Pause Button
8.2 - Indicators
The status of the device is indicated by several lights surrounding the buttons on the top
of the Controller.
Battery Indicator
Headphone Indicator
Tonguetip Indicator
Treatment Indicator

IFU-0026 Lenire User Manual Version 2.0
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Battery Indicator
Green The battery power is ok.
Orange The battery has less than 1 hour of power remaining. Please charge
the device before next use (see Chapter 10).
Red The battery is exhausted. The device will shut o automatically. Please
charge the device before next use (see Chapter 10).
Orange (Pulsing) The Charger is connected and the battery is charging.
Green (Pulsing) The Charger is connected and the battery is fully charged.
Headphones Indicator
Blue (Pulsing) The Controller is trying to establish a wireless connection to the
Headphones.
Green The Controller is connected wirelessly to the Headphones.
Blue
(Pulsing Rapidly)
The Controller is attempting to pair with the Headphones, see Chapter 20
for details.
Orange
(Pulsing Rapidly) The Controller is not congured for the connected Headphones.
Tonguetip Indicator
Blue (Pulsing) There is no Tonguetip connected.
Green (Pulsing) The Tonguetip is connected but it is not in contact with the tongue.
Green The Tonguetip is connected and it is in contact with the tongue.
Orange or Orange
(Pulsing)
The Tonguetip has less than 10 hours of use remaining before expiry.
Please purchase a new Tonguetip to avoid disruption to your treatment
regime.
Red The Tonguetip has expired. Please purchase a new Tonguetip to continue
treatment.
Treatment Indicator
White (Pulsing) The treatment session is paused.
White (Animated) The treatment session is active – the white light rotates around the
buttons.
Green (Pulsing) The treatment session has completed.
When the device is powered o, none of the lights will be illuminated.