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IFU-0002 Lenire

User Manual Version 1.0

Page 49

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

• Spot frequencies per EN 60601-1-2:2015 Table 9 at up to 28 V/m

IEC 61000-4-2 (Electrostatic Discharge)

• +/- 8kV Contact Discharge

• +/- 15kV Air Discharge

IEC 61000-4-8 (50Hz/60Hz magnetic fields) at 30 A/m

Disturbances higher than these limits are unlikely to be encountered in the

home healthcare or professional healthcare environments.

Содержание CE-401

Страница 1: ...IFU 0002 V2 0...

Страница 2: ...trolling 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...

Страница 3: ...ge 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 effective use You should read an...

Страница 4: ...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...

Страница 5: ...ual characteristics during the initial fitting procedure by a trained clinician Chapter 2 Intended Use The Lenire device is intended to be used by tinnitus sufferers of at least 18 years of age to all...

Страница 6: ...ss directed by a doctor You are pregnant unless directed by a doctor You suffer from epilepsy or any other condition that may result in loss of consciousness You suffer from any condition that causes...

Страница 7: ...n 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...

Страница 8: ...rgy 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 no...

Страница 9: ...s 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 th...

Страница 10: ...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 comp...

Страница 11: ...er 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 indica...

Страница 12: ...02 Lenire User Manual Version 1 0 Page 11 Section B Using Lenire This section describes the components controls and indicators of Lenire and outlines the steps required to prepare for and commence tre...

Страница 13: ...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...

Страница 14: ...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 Theheadphonesarepoweredby...

Страница 15: ...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 off 2 Play Button Press t...

Страница 16: ...ill shut off 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 batte...

Страница 17: ...guetip 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...

Страница 18: ...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 pr...

Страница 19: ...dication 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...

Страница 20: ...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 t...

Страница 21: ...ime 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...

Страница 22: ...ler Plug the cable end of the supplied Charger XP Power model VEP08US05 XE0767 into the Controller port of the Controller Plug the Charger into a mains electrical socket While charging the Battery Ind...

Страница 23: ...XE0767 into the USB Port of the Headphones Plug the Charger into a mains electrical socket An empty battery should take no more than 3 hours to fully recharge and a full charge should allow the Lenir...

Страница 24: ...ow the light beside the Headphones power button will blink red and the headphones will emit a sequence of low pitch beeps An empty battery should take no more than 3 hours to fully recharge and a full...

Страница 25: ...treatment session It is essential that the left and right earphones cover the left and right ears respectively This is because the device calibration is unique to each ear it is based on your audiogra...

Страница 26: ...er by pressing the Power Button for two seconds The Controller will attempt to connect to the Headphones during which time the Headphones Indicator will pulse blue Once the connection to the Headphone...

Страница 27: ...clear film designed to be peeled open in the area closest to the V shaped seal If the packaging is damaged the tonguetip should not be used and it should be returned to the point of sale Before connec...

Страница 28: ...st there comfortably Once adequate contact is made with the tongue the tonguetip Indicator should stop pulsing it should illuminate green without pulsing For maximum comfort the mouth and jaw should r...

Страница 29: ...fortable position press the Play Button to commence the treatment The Treatment Indicator white will rotate around the display A single treatment session lasts approximately 30 minutes from the time t...

Страница 30: ...ng the Pause Button The Treatment Indicator will pulse white instead of rotating around the display The treatment session will automatically pause if the tonguetip loses contact with the tongue for mo...

Страница 31: ...was perceived during the initial training you received as part of the device fitting In this case the tongue stimulus level may be adjusted upwards The tongue stimulus is calibrated to your sensation...

Страница 32: ...vels are calibrated to your hearing thresholds for optimum effectiveness Depending on your audiological profile you may perceive the sound levels to be soft It is important that you seek a quiet envir...

Страница 33: ...iet relaxing and comfortable Focusing your attention away from distractions such as the TV may improve the effectiveness of the treatment Try to keep a routine for the treatment sessions where the tre...

Страница 34: ...0002 Lenire User Manual Version 1 0 Page 33 Section C Care Storage Maintenance and Disposal This section details the correct procedures for cleaning storage maintenance and disposal of the Lenire sys...

Страница 35: ...ore cleaning the Controller or Headphones ensure that they are switched off and not connected to the Charger Before cleaning the tonguetip ensure that it is disconnected from the Controller Do not exp...

Страница 36: ...amaging the devices do not force dry for example by using a hairdryer or leaving on top of a heater Chapter 16 Storage and Transport It is recommended to store the Controller and the tonguetip in the...

Страница 37: ...years of it being manufactured otherwise the battery life may deteriorate The environmental limits and precautions pertaining to storage and transport of the device are illustrated on the packaging la...

Страница 38: ...ncerns following these inspections cease using the device and request assistance by contacting Customer Support see page 53 for contact details 17 2 Controller Service Life The Controller has an expec...

Страница 39: ...r will flash red and treatment sessions will not commence until a non expired tonguetip is connected A new tonguetip Model TP 101 can be purchased from Customer Support See page 53 for contact details...

Страница 40: ...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 co...

Страница 41: ...pport see page 53 19 2 What should I do if there is no sound coming from the Headphones Ensure the Headphones are charged see page 20 Ensure the Headphones are paired to the Controller If they are not...

Страница 42: ...ate to your hearing thresholds during the device fitting with a trained clinician The range of adjustment above and below this optimum level is limited in order to maximise the treatment effectiveness...

Страница 43: ...should I do if the Controller is not charging If your Controller is not charging please try the following Check the mains plug on the Charger is fully clicked in Check if the Charger is working by co...

Страница 44: ...atment it is important to adhere to the treatment regimen prescribed by your clinician If you miss a treatment session on any particular day it is advisable that you continue treatment as normal the f...

Страница 45: ...nd Headphones together you may need to pair the devices as follows Put the Headphones into Pairing Mode by first ensuring they are powered off and then powering them on by briefly pressing the Headpho...

Страница 46: ...Headphones The Headphones Indicator on the Controller will pulse rapidly during this procedure If no discoverable Headphones are found within 20 minutes the Controller will shut down Otherwise the Con...

Страница 47: ...cators 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...

Страница 48: ...ion 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...

Страница 49: ...precludes the use at altitudes above 3000m unless traveling in an airplane that has the cabin pressurised Chapter 24 Radio Frequency RF Specifications The Lenire Controller contains a Bluetooth wirele...

Страница 50: ...4 3 radiated electromagnetic fields 80 MHz to 2 7 GHz at 10V m 2 7 GHz to 6 GHz at 3V m Spot frequencies per EN 60601 1 2 2015 Table 9 at up to 28 V m IEC 61000 4 2 Electrostatic Discharge 8kV Contac...

Страница 51: ...euromod Devices Limited and should be kept at least 30cm away from it when in use Otherwise degradation of the performance of this equipment could result Lenire should not be used adjacent to or stack...

Страница 52: ...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 co...

Страница 53: ...ed declares that the radio equipment type are Wideband Data Transmission Equipment in the 2 4 GHz ISM band operating in the frequency range 2 4 GHz to 2 4835 GHz per ETSI 300 328 v 2 1 1 is in complia...

Страница 54: ...ort Contact Details General Contact Details E mail info neuromoddevices com Web www neuromoddevices com Customer Support Contact Details E mail techsupport neuromoddevices com Web www neuromoddevices...

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