LENIRE CR-201 Manual de usuario
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 eective 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 suerers 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.
IFU-0002 Lenire User Manual Version 1.0 Page 5
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 suer from epilepsy or any other condition that may result in loss
of consciousness.
• You suer 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:
IFU-0002 Lenire User Manual Version 1.0Page 6
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.
IFU-0002 Lenire User Manual Version 1.0 Page 7
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.
IFU-0002 Lenire User Manual Version 1.0Page 8
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.
IFU-0002 Lenire User Manual Version 1.0 Page 9
Ingress Protection (IP) Rating: IP ratings describe
how eectively 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.
Este manual sirve para los siguientes modelos
2
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