LENIRE CR-201 User Manual
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LENIRE CR-201 User Manual

Tinnitus treatment system
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IFU-0002 V2.0

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Summary of Contents for LENIRE CR-201

  • Page 1 IFU-0002 V2.0...

  • Page 2: Table Of Contents

    Chapter 25 - Guidance and Declaration for Electromagnetic Compatibility Chapter 26 - Materials in Direct Contact with Human Tissue Chapter 27 - Declaration of Conformity Radio Equipment Directive 2014/53/EU Section F - Customer Support Contact Details IFU-0002 Lenire User Manual Version 1.0 Page 1...

  • Page 3: Using This Manual

    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 effective use. You should read and understand these instructions before use. Page 2...

  • Page 4: Section A - General Information

    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 1.0 Page 3...

  • Page 5: Chapter 1 - Introduction

    Chapter 2 - Intended Use The Lenire device is intended to be used by tinnitus sufferers 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.

  • Page 6: Chapter 3 - Contraindications

    You suffer from epilepsy or any other condition that may result in loss of consciousness. • You suffer 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. IFU-0002 Lenire User Manual Version 1.0 Page 5...

  • Page 7: Chapter 4 - Risks Associated With Use

    Chapter 4 - Risks Associated with Use Potential risks associated with use of the Lenire device include: 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.
  • Page 8 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.

  • Page 9: Chapter 6 - Product And Package Labelling

    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. Page 8 IFU-0002 Lenire User Manual Version 1.0...
  • Page 10 This symbol signifies that the device should not be disposed of as domestic waste. This ensures compliance with the Battery Directive 2006/66/ The logo for this product range (Lenire tinnitus treatment system). This symbol (direct current) identifies a charging port.
  • Page 11 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. Page 10 IFU-0002 Lenire User Manual Version 1.0...

  • Page 12: Section B - Using Lenire

    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. IFU-0002 Lenire User Manual Version 1.0 Page 11...

  • Page 13: Chapter 7 - Product Components & Accessories

    Carry case which can be used to store the Controller and tonguetip in- between uses. The Lenire system box also contains a Quick Start Guide which outlines the basic steps needed to commence a treatment session. Page 12 IFU-0002 Lenire User Manual Version 1.0...
  • Page 14 These headphones are an accessory that must be used with the Lenire system and are made available to you at the time of purchase. Lenire is designed to work only with the AKG K845 BT Headphones, and will not connect to any other Bluetooth devices.

  • Page 15: Chapter 8 - Controls And Indicators

    Hold this button for 2 seconds to switch the device off. 2. Play Button Press this button to start or resume the treatment session. 3. Pause Button Press this button to pause the treatment session. Page 14 IFU-0002 Lenire User Manual Version 1.0...
  • Page 16 Blue (Pulsing) connection to the Headphones. The Controller is connected wirelessly to the Green Headphones. Blue The Controller is attempting to pair with the (Pulsing Rapidly) Headphones, see page 44 for details. IFU-0002 Lenire User Manual Version 1.0 Page 15...
  • Page 17 The treatment session is active – the white light White (Animated) rotates around the buttons. Green (Pulsing) The treatment session has completed. When the device is powered off, none of the lights will be illuminated. Page 16 IFU-0002 Lenire User Manual Version 1.0...
  • Page 18 Please see page 31 for 30 for guidelines on setting the guidelines on setting the volume stimulation intensity. level. Indication of default (optimum) Indication of default (optimum) tonguetip stimulus intensity Headphones volume level IFU-0002 Lenire User Manual Version 1.0 Page 17...
  • Page 19 Indication of minimum stimulus intensity 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. Page 18 IFU-0002 Lenire User Manual Version 1.0...

  • Page 20: Chapter 9 - Controller Port

    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. IFU-0002 Lenire User Manual Version 1.0 Page 19...

  • Page 21: Chapter 10 - Charging The Controller And Headphones

    Chapter 10 - Charging the Controller and Headphones Before Lenire is used for the first time, it is recommended that the Controller and the Headphones be fully charged. Only use the supplied Charger with the Lenire device. To avoid the risk of electric shock, do not connect or disconnect the Charger from the mains if it, or your hands, are wet.
  • Page 22 XE0767) into the Controller port of the Controller. • Plug the Charger into a mains electrical socket. While charging, the Battery Indicator will pulse orange. Once the battery is fully charged, the Battery Indicator will pulse green. IFU-0002 Lenire User Manual Version 1.0 Page 21...
  • Page 23 An empty battery should take no more than 3 hours to fully recharge, and a full charge should allow the Lenire device to be used for at least 8 hours. Once the battery is fully charged, the Charger should be disconnected to help conserve the life of the battery in the Controller.
  • Page 24 Headphones to be used for at least 8 hours. Once the battery is fully charged, the Charger should be disconnected to help conserve the life of the battery in the Headphones. IFU-0002 Lenire User Manual Version 1.0 Page 23...

  • Page 25: Chapter 11 - Device Setup

    Chapter 11 - Device Setup To commence a treatment session, the Lenire device should be set up as follows: 11.1 - Controller and Headphones Setup The Headphones should be worn so they cover both ears and should be adjusted to maximise comfort before commencing the treatment session.
  • Page 26 Headphones during the device fitting. If they are not paired, or if you are having difficulty connecting to the Headphones, then you should follow the instructions on page 44. IFU-0002 Lenire User Manual Version 1.0 Page 25...

  • Page 27: Chapter 12 - Tonguetip Setup

    The tonguetip must be connected to the Controller by plugging it into the Controller port, such that the label side of the plug faces away when viewed from the front of the Controller. Page 26 IFU-0002 Lenire User Manual Version 1.0...
  • Page 28 User Manual. The tonguetip model TP-101 is designed to function for 360 treatment sessions (180 hours) before expiring. Indications of imminent expiry and actual expiry are outlined on page 16. IFU-0002 Lenire User Manual Version 1.0 Page 27...

  • Page 29: Chapter 13 - Starting And Controlling A Treatment Session

    It is essential that you continue to listen to the sound during the fade out period, i.e. until the treatment session is complete. Once the treatment session is complete, the Treatment Indicator will pulse green. Page 28 IFU-0002 Lenire User Manual Version 1.0...
  • Page 30 5 minutes. It is also recommended that you do not pause the treatment more than once within a single treatment session in order to maximise the effectiveness of the treatment. IFU-0002 Lenire User Manual Version 1.0 Page 29...
  • Page 31 Indicator is illuminated green (i.e. when it is not pulsing). Page 30 IFU-0002 Lenire User Manual Version 1.0...
  • Page 32 Depending on your hearing profile, the range over which you can increase the Headphones volume level may be limited. This is to ensure that the volume levels remain within safe limits so as not to cause hearing damage. IFU-0002 Lenire User Manual Version 1.0 Page 31...

  • Page 33: Chapter 14 - Treatment Guidelines

    Do not use whilst showering, in rain, or in a moist atmosphere such as a steam bath or sauna. Do not use whilst applying items such as, perfume, cosmetics, after-shave, hairspray or suntan lotion. Page 32 IFU-0002 Lenire User Manual Version 1.0...

  • Page 34: Section C - Care, Storage Maintenance And Disposal

    Section C - Care, Storage, Maintenance and Disposal This section details the correct procedures for cleaning, storage, maintenance and disposal of the Lenire system. IFU-0002 Lenire User Manual Version 1.0 Page 33...

  • Page 35: Chapter 15 - Cleaning

    In addition, the tonguetip may be cleaned by gently rubbing the tonguetip surfaces, including the electrodes and the plug using 70% IPA (Isopropyl alcohol) wipes. Notes: 70% IPA wipes are available over the counter in pharmacies. Page 34 IFU-0002 Lenire User Manual Version 1.0...

  • Page 36: Chapter 16 - Storage And Transport

    Carry case. For ease of storage, it is possible to leave the tonguetip cable outside the case, whereby the cable enters and exits the case through the holes as indicated in this image: IFU-0002 Lenire User Manual Version 1.0 Page 35...
  • Page 37 Storage and transport humidity limits. The lower limit, 5%, as indicated near the lower horizontal line and the upper limit, 85%, as indicated near the upper line. Page 36 IFU-0002 Lenire User Manual Version 1.0...

  • Page 38: Chapter 17 - Maintenance

    • The Controller should be charged every 6 months if not in use. Not charging the battery for extended periods may reduce the capacity of the battery and shorten the service life of the device. IFU-0002 Lenire User Manual Version 1.0 Page 37...

  • Page 39: Chapter 18 - Disposal

    Chapter 18 - Disposal Please consider your personal safety and the environment when disposing of the Lenire system. When the device, or any of its components have reached the end of their service life, they should be disposed of in accordance with local regulations, or returned to the manufacturer (see page 53 for contact details).

  • Page 40: Section D - Troubleshooting

    Section D - Troubleshooting The following section describes problems commonly encountered while using the Lenire device, and their most common solutions. If a particular problem cannot be rectified, you should contact Customer Support (see page 53 for contact details). IFU-0002 Lenire User Manual Version 1.0...

  • Page 41: Chapter 19 - Frequently Asked Questions

    Indicator on the Controller should revert to pulsing blue. • Please ensure that the tonguetip is connected and that it has not reached expiry i.e. the tonguetip Indicator is illuminated either green or orange, but not red. Page 40 IFU-0002 Lenire User Manual Version 1.0...
  • Page 42 (see page 30). • Ensure that the tonguetip Indicator illuminates green (non-pulsing) when the tonguetip is making contact with your tongue. If it is not, please contact Customer Support (see page 53). IFU-0002 Lenire User Manual Version 1.0 Page 41...
  • Page 43 Charger. Please contact Customer Support (see page 53). • Retry charging the Controller - if there is still not an indication of charging, please contact Customer Support (see page 53). Page 42 IFU-0002 Lenire User Manual Version 1.0...
  • Page 44 Turning off any mobile phones, or other computer devices that are close by. • Moving to a different location, away from any computer devices. If none of these steps fixes the problem, please contact Customer Support (see page 53).   IFU-0002 Lenire User Manual Version 1.0 Page 43...

  • Page 45: Chapter 20 - Bluetooth Pairing / Un-Pairing

    Switch on the Controller by pressing the Power Button for 2 seconds. • Place the Controller into Pairing Mode by pressing the Play, Pause and Volume + Buttons at the same time. All indicator lights will flash blue for 2 seconds. Page 44 IFU-0002 Lenire User Manual Version 1.0...
  • Page 46 If no discoverable Headphones are found within 20 minutes, the Controller will shut down. Otherwise, the Controller will connect to the Headphones and the Headphones Indicator on the Controller will illuminate green. IFU-0002 Lenire User Manual Version 1.0 Page 45...

  • Page 47: Chapter 21 - Servicing

    Chapter 22 - Device Errors If any of the following error indicators occur that prevents the use of the Lenire system, please contact Customer Support (see page 53 for contact details). The errors will be indicated via the lights on the Controller. All but one of the lights will turn solid red.

  • Page 48: Section E - Technical Information

    Section E - Technical Information The following section outlines technical information pertaining to the Lenire device. This information is included in order to conform to international safety standards for medical devices. There is also important information included in the following section relating to environmental operating conditions and use in the vicinity of other electrical devices such as mobile phones.

  • Page 49: Chapter 23 - Environmental Operating Conditions

    Chapter 23 - Environmental Operating Conditions Lenire should only be used in environments between 5 and 40 degrees Celsius, relative humidity between 15% and 93%, and atmospheric pressure of between 700 and 1060 hPa. This precludes the use at altitudes above 3000m, unless traveling in an airplane that has the cabin pressurised.

  • Page 50: Chapter 25 - Guidance And Declaration For Electromagnetic Compatibility

    Chapter 25 - Guidance and Declaration for Electromagnetic Compatibility The Lenire system has been tested for electromagnetic performance to the following standards: » IEC61000-4-3 (radiated electromagnetic fields) • 80 MHz to 2.7 GHz at 10V/m • 2.7 GHz to 6 GHz at 3V/m •...
  • Page 51 The Lenire system is intended for use in the home healthcare and professional healthcare environments only. The performance of the Lenire in environments with high electromagnetic disturbances, e.g. near magnetic resonance imaging (MRI) or high frequency surgical equipment has not been evaluated and the Lenire should not be used in such environments.

  • Page 52: Chapter 26 - Materials In Direct Contact With Human Tissue

    Chapter 26 - Materials in Direct Contact with Human Tissue The Lenire system does not contain phthalates, latex, human blood derivatives or cells or tissues of human or animal origin. The electrodes of the tonguetip contain nickel. Note: For a complete list of materials in contact with human tissue, contact Neuromod Devices Limited.

  • Page 53: Chapter 27 - Declaration Of Conformity Radio Equipment Directive 2014/53/Eu

    (operating in the frequency range 2.4 GHz to 2.4835 GHz) per ETSI 300 328 v.2.1.1. is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.neuromoddevices.com. Page 52 IFU-0002 Lenire User Manual Version 1.0...

  • Page 54: Section F - Customer Support Contact Details

    Section F - Customer Support Contact Details General Contact Details Neuromod Devices Limited, Rainsford St, Dublin, D08 R2YP, Ireland. E-mail: info@neuromoddevices.com Web: www.neuromoddevices.com Customer Support Contact Details E-mail: techsupport@neuromoddevices.com Web: www.neuromoddevices.com IFU-0002 Lenire User Manual Version 1.0 Page 53...
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This manual is also suitable for:

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