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.

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Section A -
General Information
This section outlines the general information relating to the Lenire system,
including important safety information.

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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.

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Chapter 3 - Contraindications
• You have a pacemaker, defibrillator 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 inflammation of the oral cavity, unless
directed by a doctor.
Caution! – Do not use the device if:

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Chapter 4 - Risks Associated with Use
Potential risks associated with use of the Lenire device include:
Chapter 5 - General Warnings
Contact between the tonguetip and dental retainers or
metal fillings may cause temporary discomfort.
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.

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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.
Do not attempt to replace the Lithium Ion battery in your
Lenire device. Replacement of the battery should be
performed by a qualified individual only; attempts to
replace the battery by an inadequately trained person
may result in risks including overheating and fire.
Do not use in conjunction with a hearing aid.
To avoid the risk of a burn do not puncture, crack or
crush the Controller.

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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, Lot Number and
Model Number appears next to these symbols.
You will need these numbers if you call Customer
Support for assistance. See page 53 for the
manufacturer’s contact details.

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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.
fingers, 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 signifies 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 tinnitus
treatment system).
This symbol (direct current) identifies 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 configure your device.

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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 horizon-
tal 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, signifies compliance
with applicable EU Directives.
The number (2797) is the Notified Body number
for the British Standards Institute (BSI), who ap-
proved Lenire for CE Marking.

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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.

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Controller
The Lenire 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) is used to
charge the Controller and the
Headphones.
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.
Chapter 7 - Product Components & Accessories
In the Lenire system box, you will find:
The Lenire system box also contains a Quick Start Guide
which outlines the basic steps needed to commence a
treatment session.

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7.1 - Headphones
Lenire must be used in conjunction with
a set of Bluetooth Headphones. For best
performance, it is essential that you use AKG
K845BT Headphones.
These headphones are an accessory that
must be used with the Lenire system and are
made available to you at the time of purchase.
7.2 - Batteries
The Controller is powered by a 3.7V Lithium Ion battery. The battery is
charged using the supplied charger. See chapter 10 for instructions on
how to charge the Controller. The Controller battery is pre-fitted and is not
intended to be replaced.
The headphones are powered by 3.7V Lithium Ion battery. The headphones
are also charged using the supplied charger.
See chapter 10 for instructions on charging the Controller and Headphones.
If there are diculties charging the Controller or the Headphones, see the
section on Troubleshooting or contact Customer Support (See section F).
Lenire is designed to work only with the AKG K845
BT Headphones, and will not connect to any other
Bluetooth devices.

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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.

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8.2 - Indicators
The status of the device is indicated by several lights surrounding the
buttons on the top of the Controller.
Battery Indicator
Green The battery power is ok.
Orange
The battery has less than 1 hour of power remain-
ing. Please charge the device before next use
(see page 20).
Red
The battery is exhausted. The device will shut o
automatically. Please charge the device before
next use (see page 20).
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 page 44 for details.
Battery Indicator
Headphone Indicator
tonguetip® Indicator
Treatment Indicator

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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.

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8.3 - Headphones Volume and Tonguetip Stimulus Controls
Tonguetip Stimulation Control
The tonguetip stimulation intensity
can be adjusted to a comfortable
level by pressing the buttons
indicated below. Please see page
30 for guidelines on setting the
stimulation intensity.
Headphones Volume Control
The Headphones volume can be
adjusted to a comfortable level
by pressing the buttons indicated
below. Please see page 31 for
guidelines on setting the volume
level.
Indication of default (optimum)
tonguetip stimulus intensity
Indication of default (optimum)
Headphones volume level

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Indication of maximum tonguetip
stimulus intensity
Indication of maximum
Headphones volume level
Indication of minimum tonguetip
stimulus intensity
Indication of minimum
Headphones volume level
The Headphones volume and tonguetip stimulus are
calibrated to the optimum levels during device fitting
by the clinician. For further details, please see page 30.

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Chapter 9 - Controller port
The Controller port is used to connect the tonguetip and the Charger
to the Controller. For safety, the tonguetip and the Charger cannot be
connected to the Controller at the same time.
The following symbols are adjacent to the Controller port:
This symbol (direct current) identifies a charging
port.
This symbol represents the tonguetip.
The USB symbol – this is the connection that is
used by the clinician when they configure your
device.
This symbol indicates that the tonguetip pro-
vides a high degree of protection against electric
shock.
The tonguetip and the supplied Charger are the only
equipment that should ever be plugged into the
Controller port.