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Description of symbols used on the regulatory packaging label

Medical Device

The device is a medical device.
Keep dry

Indicates a medical device that needs to be protected from moisture.

Caution symbol

Consult instructions for use for warnings and cautions.
Catalogue number

Indicates the manufacturer’s catalogue number so that the medical device can be

identified.
Serial number

Indicates the manufacturer’s serial number so that a specific medical device can be

identified.

Battery recycling symbol

Li-ion Battery recycling symbol.

Temperature limit

Indicates the temperature limits to which the medical device can be safely exposed.

Humidity limitation

Indicates the range of humidity to which the medical device can be safely exposed.
RFID

Indicates the presence of a passive radio-frequency identification tag incorporated into

the device for manufacturing and service purposes.

Содержание CROS MNR T R

Страница 1: ...www sonici com Sonic CROS MNR T R Instructions for Use ...

Страница 2: ...nic CROS MNR T R and covers both CROS and BiCROS CROS BiCROS Sonic CROS MNR T R is to be used with compatible Sonic hearing aids For an overview of which hearing aids Sonic CROS MNR T R is compatible with visit www sonici com cros compatibility ...

Страница 3: ...e additional questions contact your hearing care professional A hearing care professional hearing aid professional audiologist ENT ear nose and throat doctor and hearing aid dispenser is a person who is appropriately educated and has proven competency in professionally assessing hearing selecting fitting and delivering hearing instruments and rehabilitation care to persons with hearing loss The ed...

Страница 4: ... of your specific hearing aid solution refer to your hearing aid s instructions for use For your convenience this booklet contains a navigation bar to help you navigate through the different sections About Getting started Daily use Warnings More info ...

Страница 5: ... a hearing aid and their caregivers Hearing care professional responsible for adjusting the hearing aid Intended user group Adults and children older than 5 years Use environment Indoor and outdoor Contraindications Not suitable for infants and children below 5 years of age For children from 5 to 8 years of age caution is advised Users of active implants must pay special attention when using the d...

Страница 6: ...arted Turn transmitter ON OFF using the charger 14 Turn transmitter ON OFF using the push button 15 Charging time 16 Low battery indication 18 Battery performance 19 Cleaning 20 Daily use Put on the transmitter 22 Change volume on the transmitter 23 Hearing aid sound 24 Change volume on the hearing aid 25 ...

Страница 7: ... filter 28 Replace ProWax miniFit filter 29 Transmitter storage 30 Warnings General warnings 32 More info Troubleshooting 36 Water dust resistant IP68 40 Conditions of use 41 Warranty 42 Technical information 44 Sound and LED light indicators 48 ...

Страница 8: ...ly sends sound from the poorer ear s surroundings to the hearing aid placed on the better ear CROS Contralateral Routing of Signals is a solution for people with limited or no hearing in one ear combined with normal hearing in the opposite ear BiCROS Bilateral Contralateral Routing of Signals is a solution for people with limited or no hearing in one ear and hearing loss in the opposite ear ...

Страница 9: ...9 Hearing aid Transmitter Sound transmission ...

Страница 10: ...oes Rechargeable battery Can only be replaced by the hearing care professional Wax filter Wax protection Dummy speaker No sound Ear grip Holds the dummy speaker in place optional Push button Upper part Volume up Lower part ON OFF volume down Microphones Sound in LED light Charging ON OFF ...

Страница 11: ... Only for dummy speaker 60 6 mm 5 mm 8 mm 10 mm Dummy speakers The choice of size depends on what fits best in your ear Earpieces The dummy speaker uses one of the following earpieces This helps the transmitter stay in your ear Grip Tip LiteTip or Micro mould can also be used Dome sizes OpenBass dome 12 mm Open dome Bass dome single vent Power dome Bass dome double vent ...

Страница 12: ...etween the transmitter and the hearing aid The left right colour indicator helps you distinguish between left and right You can find left right colour indicators on the transmitter itself On the dummy speaker it is located as shown A RED indicator marks the RIGHT transmitter A BLUE indicator marks the LEFT transmitter ...

Страница 13: ......

Страница 14: ...t until the transmitter LED light blinks GREEN twice confirming it is ready for use Your transmitter automatically turns OFF when placed in the charger and starts charging The transmitter LED light turns ORANGE IMPORTANT NOTICE If applicable ensure that your charger is powered or that the charger s built in battery is charged when the transmitter is seated in the charging port For more information...

Страница 15: ...EEN Release the push button and wait until the transmitter LED light blinks GREEN twice The transmitter is now turned ON To turn OFF Press and hold the lower part of the push button for approximately three seconds until the transmitter LED light turns ORANGE The transmitter plays four descending tones Release the push button The transmitter is now turned OFF For information regarding tones see the...

Страница 16: ...mitter s battery is completely drained the normal charging time is 3 hours 1 hour 0 5 hour Fully charged 50 charged 25 charged When the battery is fully charged the LED light on the transmitter turns GREEN and the charging process stops automatically Leave your transmitter in the charger when you are not using it Ensure that the charger is powered or that the charger s built in battery is charged ...

Страница 17: ...Charging time may vary depending on the remaining capacity of the battery and between the transmitter and the hearing aid For instructions on how to use your charger see the charger s instructions for use ...

Страница 18: ...you hear three alternate beeps This gives you approximately two hours before the transmitter runs out of battery The beeps are repeated every 30 minutes Just before the battery runs out you hear four descending tones Three alternate beeps The battery is running low Four descending tones The battery has run out ...

Страница 19: ...rge it by placing it in the charger Be aware that restarting the transmitter does not give you more usage time For the best charging conditions ensure the room temperature is in the range of 10 C and 35 C 50 F and 95 F If your transmitter does not perform for a full day you may need to replace the battery If so contact your hearing care professional ...

Страница 20: ...wire loop for cleaning and removing earwax If you need a new MultiTool contact your hearing care professional Brush Wire loop Magnet IMPORTANT NOTICE The MultiTool has a built in magnet Keep the MultiTool at least 30 centimetres 1 foot away from credit cards and other magnetically sensitive devices ...

Страница 21: ...rush to carefully brush debris away from the openings and the surface around the openings Ensure that you do not forcefully squeeze parts of the MultiTool into the microphone openings This may damage the transmitter IMPORTANT NOTICE To clean the transmitter use a soft dry cloth The transmitter must never be washed or immersed in water or other liquids Microphone openings ...

Страница 22: ... speaker wire between your thumb and index finger The earpiece should point towards the opening of the ear canal Gently push the earpiece into your ear canal until the dummy speaker wire sits close to your head If the dummy speaker has an ear grip place it in the ear so it follows the contour of the ear Step 1 Step 2 Step 3 Ear grip optional ...

Страница 23: ... the transmitter allows you to adjust the volume of the transmitted sound You hear a high pitch beep in the hearing aid when you increase or decrease the volume MAXIMUM START UP VOLUME MINIMUM Press button to increase volume Press button to decrease volume ...

Страница 24: ...sound CROS only The microphones on the hearing aid are deactivated This means that no sound is picked up by the hearing aid BiCROS only The hearing aid sound remains the same when you adjust the volume of the transmitted sound using the push button on the transmitter ...

Страница 25: ...nd Link 2 App RC A or iPhone To change the combined sound from the transmitter and hearing aid you need a SoundClip A SoundLink 2 App RC A or iPhone Double push button hearing aids If your hearing care pro fessional has activated the volume control the push button on the hearing aid changes the transmitted sound If your hearing care pro fessional has activated the volume control the push button on...

Страница 26: ...an the standard earpiece If the earpiece is filled with earwax replace it with a new one Hold on to the dummy speaker and then pull off the earpiece Insert the dummy speaker into the exact centre of the earpiece for a secure attach ment Push firmly to ensure that the earpiece is securely fastened Step 1 Step 2 Step 3 ...

Страница 27: ...27 IMPORTANT NOTICE If the earpiece is not on the dummy speaker when removed from the ear the earpiece may still be in the ear canal For further instructions consult your hearing care professional ...

Страница 28: ...e use or replacement of wax filters contact your hearing care professional ProWax miniFit filter The dummy speaker has a white wax filter attached to the end with the earpiece The wax filter keeps wax and debris out of the dummy speaker It has no acoustic purpose Replace the filter for hygienic reasons when clogged Remove the earpiece from the dummy speaker before replacing the wax filter Wax filt...

Страница 29: ...e tool has two pins one empty for removal and one with the new wax filter Insert the empty pin into the wax filter in the dummy speaker and pull it out Insert the new wax filter using the other pin remove the tool and throw it out 1 Tool New filter New filter Empty pin Old filter Final ...

Страница 30: ...is always charged Ensure that your charger is powered or that the charger s built in battery is charged when the transmitter is seated in the charging port To ensure the longest life of the rechargeable battery in the transmitter do not expose it to excessive heat For example do not leave the transmitter in the sun in front of a window or in a car even if the transmitter is in the charger ...

Страница 31: ...then turn it OFF This way the battery can be charged again For instructions on how to charge your transmitter see the charger s instructions for use Note To protect the rechargeable battery it is necessary that you fully charge the transmitter every six months If a stored transmitter is not charged within a six month period the rechargeable battery must be replaced ...

Страница 32: ...smitter with a designated charger Other chargers risk destroying the transmitter and batteries Choking hazards and risk of swallowing batteries and other small parts The transmitter its parts and the battery should be kept out of reach of children and anyone who might swallow these items or otherwise cause injury to themselves If a battery or the transmitter is swallowed see a doctor immediately F...

Страница 33: ...for human health according to international standards for human exposure Specific Absorption Ratio SAR induced electromagnetic power and voltages into the human body The exposure values are well below international accepted safety limits for SAR induced electromagnetic power and voltages into the human body defined in the standards for human health and coexistence with active medical implants such...

Страница 34: ...le side effects The transmitter and earpiece may cause an accelerated accumulation of earwax The non allergenic materials used in the transmitter may in rare cases cause a skin irritation or other side effects If these conditions occur seek consultation with a physician Interference The transmitter has been thoroughly tested for interference according to the most stringent international standards ...

Страница 35: ... on your skin If you experience skin irritation consult your doctor For further handling instructions of your transmitter consult your hearing care professional The safety of recharging batteries using a USB connector is determined by the external signal source When connected to external equipment plugged into a power socket this equipment must comply with IEC 62368 1 or equivalent safety standard...

Страница 36: ...ature exceeds 35 C 95 F which prolongs the charging time The charger has stopped charging to protect the battery The transmitter is incorrectly seated in the charger The transmitter s LED light blinks GREEN when the transmitter is placed in the charger The transmitter has not been in use for a prolonged period of time The transmitter s LED light blinks ORANGE when the transmitter is placed in the ...

Страница 37: ...smitter into the charger This completes the charging within approximately 15 minutes Check the charging ports for foreign objects Depending on how depleted the battery in the transmitter is the transmitter automatically resumes normal charging mode after a timeframe of up to 10 minutes Ensure you leave the transmitter in the charger during this process Contact your hearing care professional ...

Страница 38: ...rom the transmitter Transmitter is out of power Transmitter is turned OFF Receiving hearing aid is turned OFF Beeping If your transmitter plays eight beeps four times consecutively your transmitter needs a microphone service check If none of the above solutions work consult your hearing care professional ...

Страница 39: ...39 Solutions Charge the transmitter Turn transmitter ON Turn hearing aid ON Contact your hearing care professional ...

Страница 40: ... do not have to worry about your transmitter getting wet when it rains or if it comes into contact with sweat Before charging the transmitter make sure to wipe off any moisture Should your transmitter come into contact with water and stop working gently wipe off any water and let the transmitter dry IMPORTANT NOTICE Do not wear your transmitter while showering or participating in water activities ...

Страница 41: ...ing Atmospheric pressure 700 hPa to 1060 hPa Transportation and storage conditions Temperature and humidity shall not exceed the below limits for extended periods during transportation and storage Transportation Temperature 20 C to 60 C 4 F to 140 F Humidity 5 to 93 relative humidity non condensing Atmospheric pressure 700 hPa to 1060 hPa Storage Temperature 20 C to 30 C 4 F to 86 F Humidity 5 to ...

Страница 42: ..._________________________________ Hearing care professional s address ___________________________________ Hearing care professional s phone ____________________________________ Purchase date ____________________________________________________ Warranty period ________________ Month ____________________________ Model ________________________ Serial no __________________________ ...

Страница 43: ...T covered by the international warranty and may void it The above international warranty does not affect any legal rights that you might have under applicable national legislation governing the sale of consumer goods in the country where you have bought your devices Your hearing care professional may also have issued a warranty that goes beyond the clauses of this international warranty Please con...

Страница 44: ...less transmission is permitted Due to the limited space available on the transmitter relevant approval markings can be found in this booklet Additional information can be found in the Specification Guide on www sonici com USA and Canada This device contains a radio module DA AU5 MNR R with the following certification ID numbers FCC ID 2ACAHAU5MRTRC IC 11936A AU5MRTRC Note The device complies with ...

Страница 45: ...s and other relevant provisions of Directive 2014 53 EU Declaration of Conformity is available at the headquarters website www sonici com doc This medical device complies with Medical Device Regulation EU 2017 745 Declaration of Conformity is available at the headquarters Sonic Innovations Inc 2501 Cottontail Lane Somerset NJ 08873 USA www sonici com doc SBO Hearing A S Denmark ...

Страница 46: ...ecycle hearing aids accessories or batteries according to local regulations Hearing aid users can also return electronic waste to their hearing care professional for disposal Electronic equipment covered by Directive 2012 19 EU on waste and electrical equipment WEEE Regulatory Compliance Mark RCM The device complies with electrical safety EMC and radio spectrum requirements for devices supplied to...

Страница 47: ...al device can be identified Serial number Indicates the manufacturer s serial number so that a specific medical device can be identified Battery recycling symbol Li ion Battery recycling symbol Temperature limit Indicates the temperature limits to which the medical device can be safely exposed Humidity limitation Indicates the range of humidity to which the medical device can be safely exposed RFI...

Страница 48: ...ounds will be transmitted to your hearing aid Volume Sound Start up volume 2 beeps Minimum maximum volume 3 beeps Volume up down 1 beep ON OFF Sound LED light ON OFF 4 descending tones Note The transmitter volume sounds are high pitched The high pitch distinguishes the transmitter sounds from the sounds of your hearing aid Long GREEN blink Long ORANGE blink 233841 UK ...

Страница 49: ...uble shooting section The transmitter s LED light blinks ORANGE when the transmitter is placed in the charger Continuously blinking See the Trouble shooting section The transmitter s LED light blinks GREEN when the transmitter is placed in the charger Continuously blinking See the Troubleshooting section Note The transmitter warning sounds are high pitched The high pitch distinguishes the transmit...

Страница 50: ...2021 05 04 233841 UK subject to change 0000233841000001 ...

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