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ACRIVA 9 ACRIVA 7 Nano BTE Nano RITE Behind-the-ear hearing instruments INSTRUCTIONS FOR USE 2 TABLE OF CONTENTS General Warnings and Safety Guidelines Introduction Acriva Nano BTE with Spira Flex Thin Tube System Acriva Nano BTE with Earhook Ear Piece Overview for Nano BTE Acriva Nano RITE with Speaker Unit Ear Piece Overview for Nano RITE Placement Operating Your Instruments Changing the Volume Level Changing Programs Muting Telecoil Function (for Nano RITE only) Telephone Use (for Nano RITE only) Changing the Battery Data Logging and Learning Operating the Hearing Instruments with the Optional RC-P Remote Control 7 13 14 15 16 17 18 20 26 27 29 30 31 32 34 36 37 3 4 38 40 58 Operating the Hearing Instruments with the Optional SoundGate Communication Device Instrument Care Using Your Hearing Instruments Tips for Communicating 62 with Hearing Impaired People 64 Your Hearing Instrument Configuration 67 Accessories 68 Environmental Protection Product Approval, Markings and Compliance 69 Cell Phone and Hearing Instrument Compatibility 71 73 International Warranty Common Problems and Solutions 74 Information for the Hearing Care Professional 80 Compliance with Requirements for Europe 82 Compliance with Radio Communications Requirements for the USA and Canada Information and Explanation of Symbols Service 84 86 90 5 Congratulations on the purchase of your new Bernafon hearing instruments. The amplification of sound provided by your hearing instruments was adjusted by your hearing care professional to the needs of your individual hearing loss. With a little practice, you will soon be on your way to better hearing. Please read the entire contents of this booklet before using your hearing instruments. It contains instructions and important information about the use and handling of your hearing instruments and batteries. 6 General Warnings and Safety Guidelines Hearing instruments and batteries can be dangerous if swallowed or improperly used. Such actions can result in severe injury, permanent hearing loss or even fatality. Familiarize yourself completely with the following general warnings before using your hearing instru-
ments. Hazard Warnings Never allow others to wear your hearing instruments, because they are adjusted for your hearing requirements and may permanently damage another persons hearing. A slap to your ear while wearing the instrument could be harmful. Avoid wear-
ing your hearing instrument while playing contact sports (e.g. rugby, football, etc.). 7 Hearing instruments, their parts and batteries should be kept out of reach of infants, children and anyone who might swallow these items or otherwise cause themselves injury. Discard batteries and keep them out of sight of infants, small children, persons of mental incapacity or pets. Clean your hearing instruments and their parts on a regular basis as recommended. Micro-organ isms from unclean instruments may cause skin irritations. Be careful with leaking battery liquid, as it is a hazardous substance. Never try to recharge non-rechargeable batteries. Never change the battery or adjust the controls of the hearing instrument in front of infants, small children and persons of mental incapacity. 8 Be aware of the possibility that your instruments may stop functioning without notice. Keep this in mind while you circulate in traffic or otherwise depend on warning sounds. Traffic or other warning sounds may also be reduced in level by a directional microphone when these sounds are coming from behind you. Remove your instruments before applying aftershave, hairspray, oils, perfume, mosquito repellent, lotions, etc. Allow the product to dry before wearing your instruments. 9 Warning to Hearing Care Professional and User Special care should be taken when fitting and using a hearing instrument with maximum sound pressure capability in excess of a maximum of 132 dB SPL
(IEC 60318-4) since there may be a risk of impairing the remaining hearing of the hearing instrument user. 10 Safety Information Hearing instruments should be used only as directed and adjusted by your trained hearing care professional. Misuse or improper adjust-
ments can result in sudden and permanent hearing loss. Hearing instruments will not restore normal hearing or prevent hearing loss resulting from organic conditions. Never put your hearing instrument or batteries in your mouth, they could easily be swallowed. Keep batteries away from medications. Batteries are easily mistaken for pills. In case a battery or hearing instrument is swallowed, see a doctor immediately. Be aware that use of a hearing instrument may cause excess ear wax to build up in the ear canal which may require removal by a trained medical professional. In rare cases, a hearing instrument or earmold may cause a discharge from the ear or allergic reaction. See a physician immediately if these conditions occur. An earmold is a custom-made product. If you experience discomfort or irritation of your ear, please see your hearing care professional immediately for modification of the earmold. 11 Never insert cleaning tools into the sound outlet or microphone inlet. This could damage the hearing instruments. Do not expose hearing instruments to extreme heat by leaving them in the car, near a radiator, etc. Do not wear your hearing instrument while swim-
ming, snorkeling or diving, as it is not designed for such activities. Do not immerse your hearing instrument in water or other liquids. It is recommended to remove your hearing instruments before sleeping. Protect your instruments by keeping them in the case when you are not wearing them. 12 Introduction The following instruments are covered in these Bernafon nano BTE IFU instructions:
Acriva Nano BTE VR_ILU_nanoBTEwithSpira_BW_HI Acriva Nano RITE AR9 N AR7 N AR9 NR AR7 NR CN_ILLU_NR_InstrumentwithSpeaker_BW_HI Acriva Nano BTE instruments are available either with earhooks or Spira Flex thin tubes. Acriva Nano RITE instruments are available either with M- or P-Speaker. 13 Bernafon nano BTE IFU Acriva Nano BTE with Spira Flex Thin Tube System VR_ILU_nanoBTEwithSpira_BW_HI 2 2a 1 8 3 4 5 6 7 1 Push button 2 Microphone 2a Second microphone 3 Adapter 4 Spira Flex thin tube 5 Sound outlet 6 Dome 7 Concha clip 8 Battery door 14 Acriva Nano BTE with Earhook VR_ILU_nanoBTEwithHook_BW_HI 3 4 2 2a 1 5 1 Push button 2 Microphone 2a Second microphone 3 Earhook 4 Sound outlet 5 Battery door 15 Ear Piece Overview for Nano BTE Domes, custom molds and earmolds are ear pieces used to secure the sound tube in your ear canal and to protect the sound outlet (2) from wax. Earmold (Used with Earhook) 2 1 3 4 5 q Earmold 1 Canal 2 Sound outlet 3 Tubing 4 Helix 5 Vent Domes Used with Spira Flex Thin Tube Open Dome q Tulip Dome q Dome, Large Vent Dome, Small Vent Power Dome q q q 2 2 2 2 2 16 Acriva Nano RITE with Speaker Unit 3 2 2a 1 8 7 9 4 6 5 10 6 Speaker CN_ILLU_NR_InstrumentwithSpeaker_BW_HI 7 Speaker unit size 1 Push button 2 Microphone 2a Second microphone 3 Connector plug 4 Wire 5 Left/right indicator marking 8 Battery door 9 Ear grip 10 NoWax filter 17 Ear Piece Overview for Nano RITE Domes, custom molds (Micro Mold and Lite Tip) and Power Molds are ear pieces used to secure the speaker in your ear canal and to protect the sound outlet (20) from wax. The custom molds have a marking (21) (red = right; blue = left). The marking should point upwards in the ear canal. The removal cord (22) is for easy removal. Open Dome Power Dome Tulip Dome 20 20 q CN_ILLU_NR_PowerMoldPowerDome_BW_HI q q 20 Custom mold
(Micro Mold, Lite Tip) Power Mold 21 20 q q 20 22 18 VR_ILU_Left-rightEarMarkingNanoBTE_BW_HI Left/Right Ear Marking A color marking inside the battery door can help you to distinguish between the left and right instruments. Red = right; Blue = left 19 Placement Bernafon nano BTE IFU It takes patience and practice to insert your ear piece correctly. If you have difficulty, please consult your hearing care professional. VR_ILU_InsertingNanoBTEhook1_BW_HI Inserting Your Nano BTE with an Earmold Hold the earmold by the tubing so that the helix part is pointing straight up and the canal part is pointing at the ear canal entrance. Insert the canal part into your ear canal, twisting slightly to ease the helix portion into place. It may help to pull the ear lobe down with the other hand, or pull the top of the ear back and up. 20 VR_ILU_InsertingNanoBTEhook2_BW_HI Run your index finger down the skin just in front of your ear. If you can touch the helix part of the earmold, it is not inserted correctly. Gently push it behind the fold of your ear. Lift the hearing instrument into place behind your ear. Be careful not to twist the tubing. Removing Your Nano BTE and Earmold Lift the instrument from your ear first. Push the back of your ear with your thumb to loosen the helix part of the earmold, then use your index finger to remove it. Grasp the helix part of the earmold and twist it forwards. Gently pull the earmold straight out of the ear, holding on to the helix part of the mold. Do not remove the earmold by pulling on the hearing instrument. This could disconnect the instrument from the earmold or damage the tubing. 21 Inserting Your Nano BTE with a Spira Flex Thin Tube Practice inserting your thin tube correctly. Bernafon nano BTE IFU VR_ILU_InsertingNanoBTEspira1_BW_HI First, position the hearing instrument behind your ear. Grasp the bend of the thin tube and gently push the dome into your ear canal until the tube rests against the side of your head. Push the ear grip into Bernafon nano BTE IFU the bowl of your ear. VR_ILU_InsertingNanoBTEspira2_BW_HI If the thin tube is sticking out from your ear, insert the dome further. If the ear grip is sticking out, it has not been positioned correctly. Bernafon nano BTE IFU VR_ILU_InsertingNanoBTEspira3_BW_HI 22 Removing Your Nano BTE and Spira Flex Thin Tube Grasp the bend of the thin tube and gently pull the tube and dome out of your ear. Lift the instrument from behind your ear. Do not remove the thin tube and dome by pulling on the hearing instrument. This might disconnect the instrument from the thin tube. 23 Inserting Your Nano RITE with a Speaker Look for the side marking:
left = blue; right = red. Make sure the dome is pushed firmly onto the speaker. Position the hearing instrument behind your ear. Grasp the speaker between your thumb and index finger. The dome or custom mold should point towards the ear canal opening. Gently push the speaker into your ear canal, until the wire sits flush against the side of your head. If you have an ear grip attached to the speaker, gently push it into your ear as shown. When looking in the mirror the speaker should be difficult to see. 24 Removing Your Nano RITE with a Speaker To remove the speaker, grasp the wire between your thumb and index finger. Do not pull on the ear grip. Gently pull the speaker out of your ear. Never insert the speaker in the ear canal without the dome attached. Do not force the speaker too deeply into your ear canal. Do not apply any lubrication to the ear piece as this may damage the speaker. If the dome is not correctly attached and falls off in the ear canal, please see your medical practitioner. Do not remove by pulling on the hearing instrument, as the speaker may be damaged at the connector. 25 Operating Your Instruments (ON/OFF) VR_ILU_OnOffFunctionNanoBTE_BW_HI Click ON Click OFF To Turn the Instrument ON Close the battery door completely. The hearing instrument will emit one long beep when it starts up. To Turn the Instrument OFF Open the battery door slightly until a click is felt. Never force the battery door open or closed. 26 Changing the Volume Level The instrument automatically adjusts the volume to the changing sound environment. If you desire to manipulate the volume yourself, your hearing care professional can program the push button to be used as a volume control. Please see page 65 to see how this has been configured for your hearing instruments. You may also use the optional RC-P remote control or the SoundGate communication device for this purpose. Please follow the detailed directions in the Instructions for Use included with these devices. Your hearing instruments will emit a click to confirm that a volume change has been made and then will beep to inform you when the maximum or minimum volume has been reached. 27 Your instrument automatically returns to a preset loudness level when it starts, the battery is low, or when the program is changed. If you find that the loudness of your hearing instrument is not adequate, your hearing care professional may need to adjust your hearing instrument settings. 28 Changing Programs Your hearing instrument can be configured with up to 4 listening programs (optional). Please see page 64 to find out which programs have been config-
ured for your hearing instruments. You can change programs as follows:
Push button A press on the button will cause the program to change. This will take 1 2 seconds until you hear the program change. The number of beeps you hear will tell you which program you are in. RC-P or SoundGate The program can be changed with either of these devices. Please see pages 37 and 38 for instructions or follow the detailed directions in the Instructions for Use included with these devices. 29 Muting Your hearing care professional can configure a Mute option in your hearing instruments. Please see page 65 to see how the push button has been configured or the Instructions for Use that are included with the optional RC-P remote. To un-mute the hearing instruments give any control on the instrument, SoundGate or RC-P a push. Do not use the Mute function to turn off the hearing instrument due to the fact that in this mode it is still drawing current from the battery. 30 Telecoil Function
(for Nano RITE only) The telecoil helps you hear better when using a telephone or in buildings where inductive loop systems are installed (places of worship, halls, theatres, etc.). When the telecoil is active, you hear directly through the telephone or inductive loop. To access the telecoil, go to the telecoil program. See page 64. This symbol or a similar sign should be displayed wherever a permanent loop has been installed. Not all telephones are compatible with the telecoil mode. 31 Telephone Use
(for Nano RITE only) Bernafon Veras IFU micro BTE VR_ILU_AutophoneControlMicroBTE_BW_HI Auto Telephone Your instrument has an Auto Telephone functio-
nality. When the hearing instrument is close to a telephone receiver, the Auto Telephone will activate a phone program. When you end your conversation, the hearing instrument will automati-
cally return to the previous program. Not all telephones can activate the Auto Telephone. The telephone receiver may need to have a special magnet fitted. Please follow the separate instructions for mounting the magnet, which are available from your hearing care professional. 32 Your hearing care professional can configure your instruments to allow answering the phone on both ears or on your preferred ear. If you have a preferred ear, the instrument on the opposite side can be programmed to sound softer or to mute when the Auto Telephone (Acriva 9 NR only) or the Telephone Program (Acriva 9 | 7 NR only) is active. Please see page 66 to find out how your instru-
ments are configured. Keep magnets out of reach of children and pets. If a magnet is swallowed, see a doctor immediately. Keep the magnet 30 cm (1 ft) away from pacemakers and other active implants. Use the magnet on the opposite side from active implantable devices. Keep the magnet 30 cm (1 ft) away from credit cards or other magnetically sensitive items. 33 Changing the Battery When the battery is running out, the instrument will beep at regular intervals. You should be prepared to replace the battery. The time until the instruments stop working depends on the battery type and manufacturer. Mercury-free batteries generally cause earlier warning beeps. Your hearing instrument uses a size 312 battery. To Change a Battery:
Gently swing the battery door fully open, but do not force it. Remove the used battery. Remove the sticker from the new battery. Place the battery into the door with the flat, smooth side facing up (+ sign). Close the battery door securely. 34 CN_ILLU_NRBatteryChanging1_BW_HI CN_ILLU_NRBatteryChanging2_BW_HI Important Battery Information Battery life will vary with conditions of use
(batteries will run down faster in noisy environments). Once the sticker is removed, it takes several seconds for the battery to give the adequate voltage. Always keep spare batteries on hand. A used battery should be replaced immediately. If you are not going to use your hearing instruments for a few days, remove the batteries. Any moisture found on a battery should be wiped off immediately with a soft cloth. Used batteries should be returned to your battery supplier or hearing care professional for safe disposal. Never dispose of batteries by burning them. They may explode and cause injury. Never dispose of batteries with household waste. They cause environmental pollution. Always remove zinc-air batteries before drying your hearing instrument with a drying kit. Drying out zinc-air batteries shortens their lifetime. 35 Data Logging and Learning Data Logging The data log automatically stores information about your use of the hearing instruments such as changes made to the volume control, hours of wear, etc. This information can be used by your hearing care professional to adjust your instruments. If you do not want this feature to be active, please ask your hearing care professional to turn it off. Data Learning If your instrument is equipped with Data Learning, your hearing care professional can activate this feature to help customize your hearing instruments. When Data Learning is operating, the instrument keeps track of how often and how much you adjust the volume control and learns your preferred setting. This new setting can be made permanent during a follow-up visit with your hearing care professional. 36 Operating the Hearing Instruments with the Optional RC-P Remote Control If you have purchased a remote control you can use it to change programs, adjust the volume level up and down, or mute the instruments. For complete operating instructions, please read the separate RC-P remote control instructions for use booklet. 1 2 3 1 Program cycle button 2 Volume control 3 Mute button 4 Status light 5 Key lock 5 4 37 Operating the Hearing Instruments with the Optional SoundGate Communication Device If you have purchased a SoundGate you may use it to perform basic functions such as program changes and volume adjustments. In addition, the SoundGate serves as a link between your hearing instruments and external sources such as music players, cell phones, computers, etc. For complete operating instructions, please read the separate SoundGate instructions for use booklet. 38 SoundGate 2 1 Power on/off 2 LED indicator 3 Volume control 4 Auxiliary Input Key 5 TV key 6 Phone key 7 Microphone inlet 8 Neck strap inlet 9 3.5 mm input jack 10 Micro-USB charger jack 8 SoundGate 1 Volume control and program change 2 Phone 3 Music/audio key 4 Bluetooth key 5 Battery indicator 6 Key lock 4 5 6 7 8 3 6 1 2 3 4 5 1 1 2 10 9 SN2_ILLU_Overview_HI SN2_ILLU_SoundgateProfile_HI 39 Instrument Care Healthy ears produce a waxy substance that can clog your hearing instruments. Please follow these cleaning instructions to prevent wax build-up and ensure optimal performance of your instruments. General Care Instructions Treat your hearing instrument like any other delicate electronic device (check the safety guidelines on page 7) and make sure that the instrument and the speaker do not come in contact with moisture or water. Always clean and dry your hands thoroughly before manipulating the instrument. Do not use your hearing instrument without a dome or mold. Never mount a used dome on the speaker or Spira Flex thin tube. 40 If Your Hearing Instrument Get in Contact with Water Should your hearing instrument get in contact with water and stop working, please follow these guidelines:
Gently wipe off any water on the outside of the hearing instrument. Open the battery door and remove the battery. Gently wipe off any water in the battery door. Let the hearing device dry with the battery door left open for approximately 30 minutes. Insert a new fresh battery (see page xy) and close the battery door. Your hearing instrument should work normally again. If your hearing instrument does not work properly, consult your hearing care professional. 41 Every Night Check your instruments for ear wax and wipe them clean with a cloth or tissue. If necessary, use the cleaning tool to remove wax from the canal and vent openings on your earmold or dome. Open the battery door fully to allow air to circulate. A dry storage kit is recommended to remove any moisture that may have accumulated in the instrument. Always remove zinc-air batteries before drying your hearing instrument with a drying kit. Drying out zinc-air batteries shortens their lifetime. 42 If you Have a Nano BTE with Earmold You should wash your earmolds regularly. The hearing instruments themselves must never be washed or allowed to get wet!
Bernafon nano BTE IFU Handle your instruments over a soft surface to avoid damage in case you drop them. VR_ILU_CleaningEarmoldAttachNano_BW_HI Disconnect the earmold from the hearing instrument by grasping the end of the hook firmly with one hand and grasping the tubing firmly with the other hand. Pull the tubing away from the earhook. Gently clean the earmold in warm soapy water. Rinse the earmold and allow it to dry completely. Use an air puffer to remove any remaining moisture in the tubing. When re-attaching the earmold to the instrument, it is important to position it correctly. 43 If You Have a Nano BTE with Spira Flex Thin Tube If you have the thin tube system, make sure that the tube and dome are kept free of ear wax at all times. Grasp the adapter firmly and disconnect the thin tube from the instrument by pulling it off. Use a soft dry cloth or tissue to clean the outside of the thin tube and dome. To remove wax from the thin tube, insert the cleaning wire at the connector end. Push the wire all the way into the thin tube until it comes out through the dome. Pull the cleaning wire out through the dome and discard it. Reattach the thin tube connector to the adapter by pushing the thin tube connector into the hearing instrument adapter. 44 If your hearing care professional has selected a vented dome for your hearing instrument, use the cleaning wire to remove the wax from the vents. Clean_SpiraflexDome4 To avoid blocking the thin tube, do not use water to clean it. 45 Exchanging the Spira Flex Thin Tube If the thin tube becomes discolored, stiff or brittle, it should be replaced. Hold the instrument by the adapter and grasp the tube close to the connector. Pull firmly to remove the old tube. Attach the new sound tube by pushing it firmly Bernafon nano BTE IFU into the connector. VR_ILU_ExchangingSpiraNanoBTE_BW_HI 46 Exchanging the Dome on the Spira Flex Thin Tube The dome should be changed regularly. The frequency of dome changes will depend on how fast ear wax builds up on the dome. Inspect your instruments dome for yellowing, hardening and cracks. In the case of these changes, consider replacing your dome or contacting your hearing care professional. Spare domes can be obtained from your hearing care professional. Clean your hands thoroughly before replacing the dome. Never change the dome with wet or dirty fingers. Remove the old dome by pulling it off the end of the thin tube. Push a new dome as far as possible onto the thin tube. When attached correctly, the dome should touch the plastic ring around the thin tube. 47 If the dome is not securely attached to the thin tube, it could fall off in your ear canal. If this happens, please see your medical practitioner. Your hands must be clean and dry before replacing the dome. Never remount a used dome on the thin tube. A remounted dome is more likely to fall off in the ear canal. 48 If You Have a Nano RITE with a Custom Mold Clean your custom mold after every use by wiping it with a clean dry cloth. In most cases, there is a hole through the custom mold (below the speaker unit). This is the vent. If the vent is plugged with wax, insert a cleaning tool from the opposite end
(nearest the speaker wire), and push through to remove the wax. If no cleaning tool was supplied with your hearing instrument, please contact your hearing care professional. 49 WaxStop System The WaxStop system is applicable for the following acoustic setups:
M-Speaker used with a Micro Mold P-Speaker used with any ear pieces
(i.e. domes and Power Mold) If you are unsure about your acoustic setup, please contact your hearing care professional to get the relevant information. Note that the WaxStop system is explained with a Micro Mold. The same procedure is also suitable if your hearing instrument is connected to a P-Speaker. 50 1) Take the stick with the new WaxStop on it (1). On the opposite end is a removal plug for the used WaxStop (2). 1 2 2) Insert the removal plug (2) into the opening of the used WaxStop and pull it slowly out. Keep the stick straight. CN_ILLU_NRWaxStopChanging_BW_HI CN_ILLU_NRWaxStopChanging1_BW_HI 51 3) To insert the new WaxStop turn the stick around and place the new filter in the sound outlet and gently remove the stick. 4) A WaxStop cannot be reused; safely throw the CN_ILLU_NRWaxStopChanging2_BW_HI stick away. 52 NoWax System The NoWax systems are applicable for the follow-
ing acoustic setup:
M-Speaker used with a dome or Lite Tip P-Speaker used with a Power Mold If you are unsure about your acoustic setup, please contact your hearing care professional to get the relevant information. Replace the wax protection on your sound outlet by following this procedure:
Visually inspect the NoWax in the end of the speaker. If it is clogged or there is no sound coming from the device, replace the NoWax filter. Note that the NoWax is explained with a M-speaker. The same procedure is also suitable if you want to change the NoWax on a Power Mold. 53 1) Remove a tool from the turtle, insert its empty end into the old filter and pull it out. 1 2) Push a new filter into the sound outlet. 2 1 3 2 CN_ILLU_NRNoWaxGuardChanging_BW_HI 3 1 CN_ILLU_NRNoWaxGuardChanging_BW_HI 3) Discard the used tool. 2 3 CN_ILLU_NRNoWaxGuardChanging_BW_HI 54 Exchanging the Speaker Unit (for Nano Rite only) The speaker and the speaker wire are delicate pieces sensitive to moisture, ear wax and mechanical overload. Manipulate them with caution. Do not pull the speaker unit off the hearing instrument by yourself. Do not twist the cable connected to the speaker. Should the speaker detach from the instrument, ask your hearing care professional for support. In some cases, the speaker unit has to be changed. Your hearing care professional will make the change. 55 Exchanging the Dome on the Speaker Unit The dome should be changed regularly. The frequency of dome changes will depend on how fast ear wax accumulates on the dome. Inspect your instruments dome for yellowing, hardening and cracks. In the case of these changes, consider replacing your dome or contacting your hearing care professional. Spare domes may be obtained from your hearing care professional. Clean your hands thoroughly before replacing the dome. Never change the dome with wet or dirty fingers. Push the new dome as far as possible onto the speaker. Make sure the dome is pushed firmly onto the speaker. Your hands must be clean and dry before replacing the dome. Never remount a used dome on the speaker. A remounted dome is more likely to fall off in the ear canal. 56 Exchanging the Dome on the Speaker Unit 1) Hold the end of the dome between your fingers and pull it off. 2) Take a fresh dome out of the package. 3) Place the new dome on the speaker so it fits securely. 57 Using Your Hearing Instruments Hearing instruments do not restore perfect hearing. They make sounds louder and help you make the most of the hearing you have. While some immediate benefit is usually noticed, it often takes several weeks for your brain to adapt to the new sounds. The following tips will help you learn to use your instruments. If you have trouble adjusting, consult your hearing care professional. Getting Started Wear your instruments at home in a quiet environment. Have a conversation with one person or listen to a news program on TV. You will benefit most if you wear your instruments all day long. Increase the time each day until you are comfortable wearing them for several hours at a time. 58 You may notice that your own voice sounds louder. If the voices of others are at a comfortable level, try speaking at a lower volume. Sounds like footsteps, chirping birds, rustling paper, etc. may seem quite loud at first because you probably havent heard them for a while. They will soon fade to the background. Dining Out Start with a quiet restaurant (no music or entertainment). Request a table away from the kitchen and other noisy areas. Conversation will be easier in a smaller group. In the Car Sit with your better ear toward the center of the car, if possible. Turn off the radio. Keep windows closed to minimize traffic, road and wind noise. 59 Attending Theatre, Concerts, Lectures, etc. Try to sit with your better ear closer to the sound source, if possible. Become familiar with the program in advance to make it easier to follow. If your hearing is similar in both ears, sit in the middle. If you wear a Nano RITE inquire if a loop is available. When the telecoil is active, you hear directly through the inductive loop (see page 31). If no loop is available, sit towards the front. At Work Inform your co-workers about your hearing loss and teach them to talk clearly. Keep eye contact when conversing. Focus on the person nearest to you. If you hear only part of a conversation, repeat what you have heard and ask for the missing information. At Home Always use your hearing instruments. Inform family and friends about your situation. Teach your family to talk clearly and keep eye contact when conversing. Teach your family how to involve you in conversations. Avoid background noise. 60 Hearing on the Telephone Hold the receiver close to the microphone inlet of your hearing instrument. If this causes whistling, move the receiver away a small distance. Before purchasing a mobile phone, test it with your hearing instrument. People with a greater degree of hearing loss may need a volume control on the telephone. For Nano RITE Hearing Instruments Only If voices over the telephone are too soft or background noise is a problem, use the telecoil
(be aware that not all phones are telecoil compatible). When using the telecoil, hold the phone behind the ear, next to your hearing instrument for better reception. Mobile phones may cause interference with the telecoil. In this case, the microphone mode will give a better result. 61 Tips for Communicating with Hearing Impaired People
(Suggestions for Family Members and Friends) Speech should be clear and distinct. Some people may need to slow down a little but if speech is too slow it can be even more difficult to understand. Do not shout! Many people with hearing impairment are very sensitive to loud sounds. If you are having difficulty being understood, rephrase the statement rather than repeating the same words several times. Do not try to have a conversation from another room or with your back turned. Talk face to face!
Avoid eating, drinking or smoking while talking and keep your hands away from your face. Minimize background noise turn off the TV or radio or move to a quiet area for conversation. Try to give some warning when the topic changes during group conversations it is much easier to follow the conversation when you know what is being discussed. Ensure there is good light on your face the eyes and ears work best together for maximum understanding of speech. 62 Encourage those with hearing instruments to wear them as often as possible. Most of all, be patient and understanding. Even when wearing hearing instruments, many people will still not hear or understand everything the first time. 63 Your Hearing Instrument Configuration Available Programs (optional) Your hearing instruments are programmed in the following way:
Program Beeps Function 1 2 3 4 1 2 3 4 Right and Left Instruments Synchronized When this feature is active, changes made to one instrument are automatically made in the other through a wireless communication link. 64 Push Button (two Nano hearing instruments) Short push
(less than 1 sec.) h Medium push
(about 1 sec.) h left volume down program change right volume up program change h h h synchronized Long push
(about 2 sec.) h mute h mute h synchronized Push Button (one hearing instrument) Short push
(less than 1 sec.) h volume down Medium push
(about 1 sec.) Long push
(about 2 sec.) h volume up h program change It is not possible to mute the hearing instrument in a monaural fitting with the push button. 65 Telephone Use Preferred telephone ear:
M Both M Right M Left Behavior of Instrument on the Non-Telephone Ear M No change M The microphone is softer when the Auto Telephone or Telephone Program is active M The instrument mutes when the Auto Telephone or Telephone Program is active 66 Accessories Bernafon offers a wide range of optional accessories that may be purchased to enhance your hearing system. Depending on hearing instrument type and local regulations, the following accessories are available:
Remote control (RC-P) SoundGate communication device (for wireless connection to cell phones, music players, etc.) TV adapter (for wireless connection to your television via the SoundGate) Phone adapter (for wireless connection to your landline phone via the SoundGate) Cleaning and drying kit For further information on accessories please contact your hearing care professional. 67 Environmental Protection Your hearing instruments contain electronic components subject to the Directive 2002/96/EC on waste electrical and electronic equipment. Help to protect the environment by not disposing of your hearing instruments or batteries with your unsorted household waste. Please recycle your hearing instruments and batteries according to your local regulations or return them to your hearing care professional for disposal. 68 Product Approval, Markings and Compliance All Bernafon Acriva hearing instrument models comply with international standards concerning electromagnetic compatibility. Due to the limited size available on the instruments all relevant approval markings are found in this document. Electromagnetic Interference Your hearing instrument has been thoroughly tested for electromagnetic interference. However, some products may emit electromagnetic energy causing unforeseen interference with hearing instruments. Examples include induction cooking appliances, shop alarm systems, mobile phones, fax machines, personal computers, X-rays, CT scans, etc. Even though your hearing instruments are designed to comply with the most stringent international standards of electromagnetic compatibility, they may emit electromagnetic energy that can cause interference with other devices. 69 Your hearing instruments contain a radio transmitter using short range magnetic induction technology working at 3.84 MHz. The magnetic field strength of the transmitter is < 42 dBA/m @ 10 m. The electromagnetic emission from the radio system is well below international limits for human exposure. By comparison, the electromagnetic energy of the hearing instrument is lower than that generated by household items such as halogen lamps, computer monitors, dishwashers etc. 70 Cell Phone and Hearing Instrument Compatibility Some hearing instrument users have reported a buzzing sound in their instruments when they are using cell phones, indicating that the cell phone and hearing instrument may not be compatible. The compatibility of a particular hearing aid and cell phone can be predicted by adding the rating for the hearing aid immunity to the rating for the cell phone emissions (ANSI C63.19-2006 American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids). For example, the sum of a hearing aid with a rating of 2 (M2/T2) and a telephone with a rating of 3 (M3/T3) would result in a combined rating of 5. According to the standard, any combined rating that equals at least 5 would provide normal use; a combined rating of 6 or greater would indicate excellent performance. 71 The immunity of your Acriva hearing instrument is at least M2/T2. The equipment performance measurements, categories and system classifica-
tions are based upon the best information available but Bernafon cannot guarantee that all users will be satisfied. 72 International Warranty Your hearing instruments have a limited warranty, covering defects in materials and workmanship. This warranty covers the hearing instruments themselves, but not accessories such as batteries, tubing, earmolds, etc. This warranty is void if a defect is the result of misuse or mistreatment. The warranty is also void if the hearing instruments have been repaired by nonauthorized service personnel. Please review the warranty with your hearing care professional and make sure that your warranty card is completed correctly. 73 Common Problems and Solutions Possible Cause Speaker and dome/mold not fully inserted Ear wax accumulation in ear canal Earmold may be too loose Tubing may be split or improperly connected Instrument may not be turned ON Battery may be dead or inserted upside down Volume level too soft Instrument may be in telecoil position Wax filter blocked by ear wax Dome may be blocked by ear wax Ear wax accumulation in the ear canal Battery contacts may be dirty or corroded Problem Instrument whistles or squeals No volume, level too soft or humming noise 74 Solution Re-insert the speaker and the dome/mold Consult your hearing care professional or physician Consult your hearing care professional Consult your hearing care professional Check that the battery door is closed completely Insert a fresh battery or re-insert the battery correctly Increase volume level with the control on the instrument or remote control Check to make sure you are in the intended program Replace the wax filter Exchange the dome Consult your hearing care professional or physician Open and close the battery door several times or clean the battery contacts carefully with a clean dry cotton swab 75 Problem No volume, level too soft or humming noise Possible Cause Speaker may be blocked Instrument sound outlet may be blocked Microphone sound inlet may be blocked Your hearing loss may have increased Instrument may be muted Whirring noise, fading, weak or motor-
boating sounds Battery contacts may be dirty or corroded Moisture in hearing instrument Low battery Low battery Instrument switches from ON to OFF periodically 76 Solution Consult your hearing care professional for changing Check the tubing and the earmold or dome Consult your hearing care professional, do not try to clean this yourself Consult your hearing care professional Press any button on the remote control or hearing instrument to unmute Open and close the battery door several times or clean the battery contacts carefully with a dry cotton swab Place instrument in Dry-Aid pack. Remove battery first. Consult your hearing care professional. Insert a fresh battery Insert a fresh battery 77 Possible Cause Low battery Problem Instrument beeps without any action from you (e.g. pro-
gram change) Dome fell off during removal Dome was not mounted correctly on the thin tube 78 Solution Insert a fresh battery Carefully remove the dome. If you cannot safely reach it, contact your medical professional. 79 Information for the Hearing Care Professional A hearing care professional should advise a prospective hearing instrument user to consult with a licensed physician (preferably an ear specialist) promptly, before dispensing a hearing instrument, if the hearing care professional determines through inquiry, actual observation or review of any other available information concern-
ing the prospective user, that the prospective user has any of the following conditions:
Visible congenital or traumatic deformity of the external or middle ear. History of active drainage from the ear within the previous 90 days. History of sudden or rapidly progressive hearing loss within the previous 90 days. Acute or chronic dizziness or vertigo. Unilateral hearing loss of a sudden or recent onset within the previous 90 days. 80 Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1000 Hz, and 2000 Hz. Visible evidence of significant cerumen accumu-
lation or a foreign body in the ear canal. Pain or discomfort in the ear. Special care should be exercised in selecting and fitting a hearing instrument whose maximum sound pressure level exceeds 132 decibels due to the fact that there may be risk of impairing the remaining hearing of the hearing instrument user. Children with Hearing Loss A child with a hearing loss should be directed to a physician for medical evaluation and to other professionals for evaluation and rehabilitation since hearing loss may cause problems with language development and the educational and social growth of a child. 81 Compliance with Requirements for Europe This device is in conformance with the require-
ments of the Directive 93/42/EEC of the Council of the European Communities concerning medical devices, MDD. This is certified by applying the following marking:
This device also complies with the essential requirements of the Directive 1999/5/EC of the European Parliament on radio equipment and telecommunications terminal equipment, R&TTE. It operates as an inductive application in a harmonized frequency band according to the Commission Decision 2008/432/EC and may be used in all member states of the EU and EFTA. This is certified by applying the following marking:
82 Declaration of conformity is available at:
Bernafon AG Morgenstrasse 131 3018 Bern Switzerland 83 Compliance with Radio Communications Requirements for the USA and Canada Bernafon AG Acriva hearing instrument models AR9 N; AR7 N FCC ID IC: 7031A-yyyyyyy U6Xyyyyyyy Acriva hearing instrument models AR9 NR; AR7 NR FCC ID IC: 7031A-yyyyyyy U6Xyyyyyyy Statement of compliance:
This device complies with part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired operation. This Class B digital apparatus complies with Canadian ICES-003. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. 84 These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that inter ference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the inter-
ference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experience radio/TV technician for help. Changes or modifications not expressly approved by Bernafon AG could void the users authority to operate the equipment. 85 Information and Explanation of Symbols The CE conformity marking indicates conformance to all applicable European Directives This symbol indicates that the products described in these instructions for use adhere to the requirements for an applied part of Type B of EN 60601-1. The surface of the hearing instrument is specified as applied part of Type B. This symbol indicates that it is important for the user to read and take into account the relevant information in these instructions for use 86 This sign indicates important safety information that must be observed to minimize risks or to avoid hazardous situations Important information for handling and product safety The crossed-out wheeled bin indicates that the European Directive on waste of electronic equipment applies The product is designed such that it functions without problem or restrictions if used as intended, unless otherwise noted in these instructions for use operating conditions transport and storage conditions During transport or storage, the temperature should not exceed the limit value of 25/60 Celsius 87 Notes 88 Notes 89 Service If none of the actions, listed on the previous pages, solve the problem, contact your hearing care professional. Do not attempt to repair your hearing instruments yourself. Place stamp with dispenser name and address here:
90
8,15 mm Placeholder for FSC logo
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, 9 New Zealand Bernafon New Zealand Ltd. Level 1, Building F 27-29 William Pickering Drive Albany, Auckland 0632 Toll Free 0800 44 22 57 Phone +64 9 415 7917 info@bernafon.co.nz United Kingdom Bernafon UK Cadzow Industrial Estate Off Low Waters Road Hamilton ML3 7QE Scotland Phone +44 1698 285 968 info@bernafon.co.uk United States of America Bernafon, LLC 2501 Cottontail Lane, Suite 102 Somerset, NJ 08873 Phone +1 888-941-4203 info@bernafon-us.com www.bernafon.com For more information about hearing and hearing loss e g n a h c o t t c e b u s
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. 8 0 Australia Bernafon Australia Pty. Ltd. 629 Nudgee Road Nundah QLD 4012 Freecall 1800 809 111 Phone +61 7 3250 0300 info@bernafon.com.au Canada Bernafon Canada Ltd. 500 Trillium Drive, Unit 15 Kitchener, Ontario Canada N2R 1A7 Phone +1 519 748 6669 Toll Free +1 800 265 8250 contact@bernafon.ca Manufacturer Bernafon AG Morgenstrasse 131 3018 Bern Switzerland Phone +41 31 998 15 15 info@bernafon.ch www.bernafon.com
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2012-12-20 | 3.84 ~ 3.84 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2012-12-20
|
||||
1 | Applicant's complete, legal business name |
Bernafon AG
|
||||
1 | FCC Registration Number (FRN) |
0016279770
|
||||
1 | Physical Address |
Morgenstrasse 131
|
||||
1 |
Bern, N/A 3018
|
|||||
1 |
Switzerland
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
g******@cetecom.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
U6X
|
||||
1 | Equipment Product Code |
F2BTE01
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
K**** F******
|
||||
1 | Title |
Team leader Quality Assuranceand Regulatory Affair
|
||||
1 | Telephone Number |
+41-3******** Extension:
|
||||
1 | Fax Number |
+41-3********
|
||||
1 |
k******@bernafon.ch
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Wireless Hearing Instrument | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
CTC advanced GmbH (former CETECOM ICT Services )
|
||||
1 | Name |
G******** S********
|
||||
1 | Telephone Number |
49-68********
|
||||
1 | Fax Number |
49-68********
|
||||
1 |
t******@ctcadvanced.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 3.84000000 | 3.84000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC