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BEHIND THE EARS HEARING AIDS Operating instructions lewi S risa S Specific function audifon hearing aids are wearable air conduction hearing aids, used to compensate for hearing loss of the wearer by recording, processing and emitting an amplified sound signal. The hear-
ing aids are available with different amplifications and output sound levels, to compensate for light to severe hearing loss. These hearing aids are not suitable for children under 36 months of age. It is additionally possible to activate the tinnitus module inte-
grated in the hearing aid to treat chronic, persistent tinnitus
(a ringing sound in the ears). The hearing aids are designed for a lifespan of 6 years. Hearing aids need to be fitted individually by a hearing care professional or ENT doctor. Diagnostics and the prescription of hearing aids are the task of an ENT doctor. Last revised: 01.09.2019 CONTENTS 1 INTRODUCTION ............................................................... 5 2 YOUR HEARING AID .......................................................... 6 2.1 Type .......................................................................... 6 2.2 Overview .................................................................... 6 2.3 Batteries ..................................................................... 7 2.31 Note on the battery ........................................... 8 2.32 Low battery warning ......................................... 9 3 OPERATION ...................................................................... 10 3.1 Construction .............................................................. 10 3.2 Inserting battery ........................................................ 11 3.3 Removing battery ....................................................... 12 3.4 Switching hearing aids on and off ................................ 13 Inserting and removing hearing aids ........................... 14 3.5 Inserting with ThinTube ..................................... 14 3.51 3.52 Inserting with ear mould ................................... 15 3.53 Removing hearing aids ...................................... 16 3.6 Volume and program selection ................................... 16 3.61 Automatic side balancing of hearing aids ........... 16 3.62 Multifunctional rocker switch ............................ 17 3.63 Volume selection ............................................... 18 3.64 Selecting the hearing programs ......................... 19 4 TINNITUS COMBI INSTRUMENT ........................................ 21 4.1 Start-up ...................................................................... 21 5 WIRELESS FUNCTIONALITY/
BLUETOOTH CONNECTIVITY ............................................ 22 5.1 Using hearing aids with iOS devices ............................ 22 5.11 5.12 Operating hearing aids with an iOS device /
iPhone ............................................................... 23 5.13 Operation via the menu MFI Hearing Devices ....... 24 5.14 Operation via the quick start menu.................... 24 Pairing hearing aids with the iOS device /
iPhone .............................................................. 22 MULTISTREAMER PRO ...................................... 26 5.3.1 Pairing hearing aids with the 5.3.2 Pairing your smartphone with the 5.2 Pairing hearing aids with an Android device ................ 25 5.3 Using hearing aids with the MULTISTREAMER PRO ............................................... 26 MULTISTREAMER PRO ...................................... 26 5.4 Flight mode ................................................................ 27 6 ACCESSORIES .................................................................... 28 6.1 Compatibility with smartphones ................................ 29 7 CARE INSTRUCTIONS ....................................................... 30 7.1 General ....................................................................... 30 7.2 Cleaning ..................................................................... 31 7.3 Drying hearing aids ..................................................... 32 8 DEALING WITH PROBLEMS ............................................... 34 9 SAFETY INSTRUCTIONS .................................................... 35 Important warnings ................................................... 35 Notes on product safety ............................................. 37 10 SIDE EFFECTS .................................................................... 40 11 OPERATING CONDITIONS ................................................. 41 12 TRANSPORT AND STORAGE CONDITIONS ....................... 42 13 ENVIRONMENTALLY FRIENDLY DISPOSAL ......................... 43 14 OTHER INFORMATION ..................................................... 44 14.1 EU Declaration of conformity ...................................... 44 14.2 FCC Statement ........................................................... 45 15 SERVICE
.......................................................................... 46 16 KEY TO SYMBOLS .............................................................. 49 9.1 9.2 WARRANTY CARD 1 INTRODUCTION Congratulations on the purchase of your new audifon hearing aids. Your hearing care professional has set this for your individual requirements. These instructions are therefore intended to help you use your audifon hearing aids properly. Please read through the following operating and care instructions carefully to avoid malfunctions and faults. If you follow the instructions, your hearing aids will prove an invaluable help in day-to-day communication with your surroundings and other people. The specific model of your hearing aids is shown on the sticker on the packaging, on the warranty card or printed on the hearing aids themselves. Please take note of the following:
Your hearing aid will not make your hearing normal again, nor will it prevent or improve any physical hearing loss. If you fail to wear your hearing aid regularly, you will not benefit fully from it. Use of a hearing aid only accounts for part of your hearing ability and may need to be supplemented by auditory training and instruction in lip reading. If you have any further questions, please contact your hearing care professional. 5 2 YOUR HEARING AID 2.3 Batteries To start your hearing aids first insert a battery in the battery compartment. Make sure you only use zinc air batteries. Please follow the instructions on the battery packaging. For the exact type of battery in your hearing aids please see the overview table. Always switch your hearing aids off after use. Remove the battery if your instruments are out of use for long periods, to avoid damage. 2.1 Type Your hearing aids are behind-the-ear hearing aids. 2.2 Technical features Model Size Battery Average Service life (zinc air) in hours Amplification dB
(peak) Indication range lewi S risa S 13 13 100 100 67 67 Minor to severe hearing loss Minor to severe hearing loss The detailed acoustic data for your hearing aid can be found in a separate data specification. This and further information are available from your hearing care professional or www.audifon.com. 6 7 2.3.1 Note on the battery Important notes:
A zinc air battery is used to supply the power for your hearing aids. This type of battery is only activated when oxygen comes through the air holes into the button cell and the chemical reaction is started. During production, the air holes are sealed with a protective strip. This means that the battery remains fresh until use, and it lasts longer when it is sealed. Removing the protective strip allows oxygen to enter and the chemical reaction is activated. Refitting the strip when the battery is not in use will not extend its service life. Your batteries should be stored at room temperature. Avoid keeping them in hot places or rooms with high humidity
(e.g. bathroom). Storage in a cooled location is not neces-
sary. Never carry batteries loose in a trouser pocket or a purse. Metal objects like coins or keys could cause batteries to short-circuit. Old batteries may contain hazardous substances or heavy metals that pollute the environment and harm health. Bat-
teries are recycled as they contain valuable raw materials such as iron, zinc, manganese or nickel. Old batteries should not be placed in household waste. Consumers are bound to dispose of batteries at a collection point provided by the local authority or sales outlet. After use you can also return the batteries in the appropriate containers at the premises of your hearing care professional for free. 2.3.2 Low battery warning An audible signal indicates the end of the battery life (approx. 30 minutes before the end of the batterys life). 8 9 3 OPERATION LEWI S, RISA S 3.2 Inserting battery 3.1 Construction The hearing aids consist of the following elements:
1 2 3 4 5 Ear hook Microphone inlets Multifunctional rocker switch Battery compartment / ON/OFF switch Type label 2 3 4 1 5 The hearing aids have side markings in the battery flap:
blue = left, red = right Your hearing aids may differ from the illustrations. Remove a battery from its packaging. If the battery has a protective film, remove and wait a few minutes before inserting the battery. Open the battery compartment carefully with your fingernail at the opening edge or press the ON/OFF switch on the battery compartment until it springs out, swing it right out. Please do not open the battery compartment any wider than shown here. This might damage the device. Then insert the battery in the battery compartment. Make sure the (+) symbol on the battery matches the (+) symbol on the battery compartment. NOTE: Do not force the battery into the battery compartment. If it does not fit, check whether you are inserting it correctly and that it is the correct type of battery (see Section 2.2). 10 11 3.3 Removing battery 3.4 Switching hearing aids on and off Open the battery compartment carefully with your fingernail at the opening edge or press the ON/OFF switch on the battery compartment until it springs out, swing it right out. Then remove the battery from the battery compartment. Please do not open the battery compartment any wider than shown in Section 3.2. This might damage the device. Your hearing aids are switched on and off via the battery compartment. Switching on Close the battery compartment securely with a battery inserted by moving it past the catch of the OFF position into the casing. You will feel the battery compartment clicking into place as you close it. The hearing aids are now switched on. After a preset delay and a start-up jingle, the first program will activate and the hearing aids are ready for use. Switching off To switch the device off, press the battery compartment via the ON/OFF switch to the first catch position. This is the OFF position. If the devices will be out of use for a long time, open the battery compartment fully and remove the battery. 12 13 3.5 Inserting and removing hearing aids 3.5.1 Inserting with ThinTube Switch the hearing aids on by closing the battery compartment securely. Hearing aid Easy Thin Tube + Dome Concha clip
(optional) Place the hearing aid behind your ear. Slide the earpiece/dome carefully into your ear canal. Rotate slightly until it is positioned properly. Open and close your mouth to avoid air being trapped in the ear cana 14 The optional concha support helps improve the fit of the earpiece in the ear. To position the concha support, bend slightly and place it carefully in the outer part of your ear. Caution: Risk of injury!
Always wear the thin sound tube with the dome and check that the dome is positioned securely on the tube. 3.5.2 Inserting with ear mould Switch the hearing aids on by closing the battery compartment securely. Hearing aid Otoplastic Place the hearing aid behind your ear. Insert the ear mould in your ear, rotating slightly as you do so. Move the upper part of the ear mould backwards and forwards to adjust. 15 3.5.3 Removing hearing aids 3.6.2 Multifunctional rocker switch Lift your hearing aid and slide carefully over the outer part of your ear. Carefully pull the tube with the earpiece out of the ear canal. Switch the hearing aid off by moving the battery compartment to the OFF position. Warning: Risk of injury!
In very rare cases the dome may remain in the ear canal on removal. Should this happen, please contact your doctor or hearing care professional at once. Please do not try to remove the dome yourself. 3.6 Volume and program selection 3.6.1 Automatic side balancing of hearing aids If you have had two hearing aids of the same type adjusted by your hearing care profes sional, they are synchronised as a pair. You can tell this, because after your devices have been switched on, the pairing melody plays in both hearing aids. After the hearing aids have been paired, all settings made in one device are also written to the second device. The tones and melodies are played in both hearing aids with a slight delay. If the connection is broken, you do not need to take action. The devices renew the connection quickly for themselves. You can tell this, because after your devices have been switched on, the pairing melody plays in both hearing aids. Your hearing aids feature a multifunctional rocker switch for controlling the volume and selecting the different programs. The multi-function rocker switch can be activated by pressing the top (+) and bottom end (-). Volume control To control the volume, press the multi-function rocker switch briefly on the top or bottom button (also see 3.6.3). Program selector switch To change the program, press the multi-function rocker switch briefly on the top or bottom button (also see 3.6.4). Volume control and program selector switch combined To control the volume, press the multi-function rocker switch briefly on the top or bottom button; to change the program hold the switch down for approx. 1 second (see also 3.6.3 and 3.6.4). 16 17 3.6.3 Volume selection 3.6.4 Selecting the hearing programs The volume can be adjusted in steps using the multi-function rocker switch. Briefly pressing the top end of the switch increases the volume, while briefly pressing the bottom end reduces the volume. When you switch your devices on, they will be at the volume set for you. You can only increase or reduce the volume in steps. Each time you press the switch, you will hear audible confirmation. Once you have reached the upper or lower volume limit, you will hear a clear signal. Volume control and program selection are optional functions. Your hearing care professional will set your hearing aids to your individual requirements. Multifunctional rocker switch Your hearing care professional will have adjusted your hearing aids to various hearing situations with you and assigned them to specific hearing programs. The multi-function rocker switch allows you to swap between the hearing programs. To do so, simply hold down one end of the multi-function rocker switch until you hear audible confirmation of the change in program with a tone. After you have released the multi-function rocker switch, the melody for the selected program is played. The number of signals indicates the number of the program selected. You can move through the hearing situations up or down. Your hearing care professional has set the number of selectable programs for your individual requirements. Program change sequence*:
+ key:
key:
1 3 2 2 3 1 Volume control and program selection are optional functions. Your hearing care professional will set your hearing aids to your individual requirements 18
* Example with 3 hearing programs 19 Hearing program Description of setting 4 TINNITUS COMBI INSTRUMENT 1 2 3 4 20 Combi hearing aids from audifon play an effective part in tinnitus therapy. These instruments are designed to accustom you to your tinnitus and/or hyperacusis and will help correct disorders of the audiological system, compensate for tinnitus and improve existing hyperacusis. Your hearing care professional will have adjusted the combi hearing aids to your individual hearing situation with you. Warning: Damage to hearing!
The maximum volume of the tinnitus combi instrument lies in a range that can lead to hearing loss according to OSHA regulations. The tinnitus combi instrument should not be used for longer than eight (8) hours, at a sound pressure level (SPL) of less than 90 dB SPL. At a higher sound pressure, the device should not be used for more than two (2) hours daily. Under no circumstances should the tinnitus combi instrument be used with a volume that is not appropriate for the user. 4.1 Start-up Information on operating devices with active tinnitus modules can be found in Section 3 of these operating instructions. 21 WIRELESS FUNCTIONALITY /
BLUETOOTH CONNECTIVITY 6. Two pairing requests appear one for each hearing aid. Select Pair to make a final connection. Both requests can be delayed by a couple of seconds. 5.1 Using hearing aids with iOS devices 7. Pairing is now complete. 5.1.1 Pairing hearing aids with the iOS device / iPhone To be able to use your hearing aids via your iOS device, you have to pair it with your iOS device. This is how the hearing aids and the iOS device communicate with each other. Please follow the instructions to successfully pair the hearing aids. 1. Press the settings icon on your iOS device. 2. In the Settings menu go to: General Accessibility MFi Hearing Devices under the hearing category 3. If the Bluetooth function is still deactivated on this screen, activate Bluetooth. While the iOS device is looking for hearing aids, open and close the battery compartments of your hearing aids (this puts the hearing aids into pairing mode) 4. Among the devices now displayed, the device name of your hearing aids appears, created based on your first names. If this does not happen within 57 seconds, press the upper left edge of the screen to go back to <Accessibility and open MFI Hearing Devices again. 5. After your hearing aids are displayed, select these from the list, to connect the devices with the iOS device. 22 5.1.2 Operating hearing aids with an iOS device / iPhone Your made-for-iPhone hearing aid is equipped for operation with an iPhone, iPad or iPod Touch. To use your hearing aid with an iOS device, pair the hearing aid as described in Section 5.1.1. There are two ways for you to operate your hearing aids with your iOS device:
1. Via the menu MFI Hearing Devices 2. Via the quick start menu of the iOS device In both menus you have access to set 1. The microphone volume 2. The desired hearing program 3. The listening function via your iOS device, with which the audio signals from the microphone of the iOS device are transmitted directly to your hearing aids. 23 5.1.3 Operation via the menu MFI Hearing Devices 5.2 Pairing hearing aids with an Android device Navigate to the sub-menu MFi Hearing Devices. You can find this under Settings General Accessibility MFi Hearing Devices Your connected hearing aids are displayed here. Select the connected hearing aids via Connected, to reach the hearing aid settings. 5.1.4 Operation via the quick start menu Press the home button three times. The MFi Hearing Devices menu opens. If you require support for pairing or using the devices listed above with your hearing aid, please contact your hearing care professional. For further operating functions, let your hearing care professional explain to you about the related free app. To be able to use your hearing aids via your Android device, you have to pair it with your Android device. This is how the hearing aids and the Android device communicate with each other. Please follow the instructions to successfully pair the hearing aids. 1. Press the settings icon. 2. Select Bluetooth. 3. Change the settings in On, if Bluetooth is switched off. Open and close the battery compartment of the hearing systems. This lets you transfer the hearing systems into pairing mode. 4. Under Paired devices you can see your first name, followed by Hearing Aid, if the hearing systems were detected. If the name does not appear on the list of paired devices within 57 seconds, press the Accessibility Icon in the top left corner, then on hearing aids. 5. The right hearing system appears on the list once, as does the left hearing system. Both list entries must be clicked for pairing. 6. Pairing is complete. 24 25 5.3 Using hearing aids with the MULTISTREAMER PRO 5.4 Flight mode When you enter an aeroplane or areas where transmission of wireless signals is forbidden, you must switch off the wireless functions of your electronic devices. For this reason, please put your hearing aids in flight mode in these situations, or if in doubt speak to trained personnel. To switch your hearing aid to flight mode, please press the multifunctional rocker switch up for 5 seconds. All wireless functions of your hearing aids are now switched off. If you switch the hearing aids off and on again, all functions are reactivated. To use your hearing aids with an Android device, a TV or other devices that have an AUX output, you can get the MULTISTREAMER PRO accessory from your hearing care professional. 5.3.1 Pairing hearing aids with the MULTISTREAMER PRO When you purchased your MULTISTREAMER PRO from your hearing care professional, you connected your hearing aids to the MULTISTREAMER PRO for the first time with them. This means that the initialisation of the connection is completed. From now on you can connect your hearing aids automatically to your MULTISTREAMER PRO. To do this, just switch on your MULTISTREAMER PRO and then (within 180 seconds) your hearing aid(s). 5.3.2 Pairing your smartphone with the MULTISTREAMER PRO Switch on the MULTISTREAMER PRO. Then press the multi-
function button for 5 seconds. The LED changes to red then flashing blue. Refresh the Bluetooth menu in your smartphone. The MULTISTREAMER PRO is displayed in the selection. Select the device, and select Pair. The MULTISTREAMER PRO is paired with your smartphone.. For further operating functions see the operating instructions of the MULTISTREAMER PRO, included with your MULTISTREAMER PRO. 26 27 6 ACCESSORIES The hearing aids of the lewi and risa families have the following accessories, which you can obtain from your hearing care professional. You can download the audifon app for free in the corresponding platforms. For more information, please contact your hearing care professional. 6.1 Compatibility with smart-phones The hearing aids of the families lewi and risa are compatible with common smart-phones, which have Bluetooth version 4.0 or higher, if necessary, the accessory product multistreamerpro be necessary for an audio transmission (eg Android operating system of the smart-phone). For a list of the lewi and risa family of hearing aids and audifon app compatible smart-phones, tablets, etc., visit:
Accessories Description www.audifon.com audifon app mutistreamer pro UniTip Soundshell UniTip Domes UniTip ThinTubes Concha Clip CeruStop Filter Side marking audifit Software from Version 5.8 smart-phone App for remote control of your hearing aids audio streamer to enhance the functionality of your hear-
ing aids Individual earmold for your hearing aids Universal ear pieces for use with your hearing aid Thin tubes to fit the hearing aids with mild to moderate hearing losses Concha clip fixes the UniTip receiver unit in the ear canal Small filter that protects the earphone from blockage and should be replaced regularly Red and blue markers that can help to easily associate the hearing aids with one ear Fitting software that the hearing aid specialist uses to fit the hearing aids for you 28 29 7 CARE INSTRUCTIONS 7.2 Cleaning The ear adapter pieces and the flexible plastic tubing attached to them must be detached from the ear hook before cleaning. Only use recommended products for cleaning the ear adapter pieces. Ear adapter piece In the case of hearing aids with a thin sound tube, the screwed connection between the tube and hearing aid can be detached. The dome is removed for cleaning. Thin Tube 7.1 General audifon hearing aids will improve your hearing ability as well as your quality of life. To ensure your hearing aids function perfectly and so make hearing a pleasant experience for years to come, audifon offers special care products designed to enable optimum cleaning of your devices. Protect your hearing aids against moisture (e.g. showers, sweat, rain), and take your hearing aids out before using hairspray or similar cosmetic products. We also recommend that you carry out daily care on your hearing aids, as the devices are exposed to moisture and dust through intended use, even if they are handled with care. Whatever type of hearing aid you use: Every one is in direct contact with the skin. This produces perspiration, which may damage your hearing aid in the long term unless dried on a daily basis. audifons behind-the-ear hearing aids are coated with a water-repellent finish, known as the nanoShield, to prevent any damage from moisture. Wearing a hearing aid or insertion of the ear adapter piece in the ear canal will always involve soiling with earwax. For this reason we recommend regular cleaning. Do not use a damp cloth to clean your hearing aids. Always use a soft, dry cloth. Should your hearing aid still not function correctly despite regular care, call on your hearing care professional. Do not try under any circumstances to repair your hearing aid yourself. 30 31 dry go The audifon dry go is the perfect solution for drying your devices when on trips or out and about. Once connected, for example to the USB port on your laptop, the drying program can be conve-
niently started at the touch of a single button. A flow of warm air inside the audifon dry go will then dry your devices reliably. The drying station switches off automatically at the end of the drying program. 7.3 Drying hearing aids Your hearing aids should be dried after use at the end of the day and above all after cleaning. If you take care of your hearing aids by drying them carefully, this will significantly increase their service life. There are two ways of doing this. If you have an audifon drying station of the type dry star UV 2 or dry go, use this for drying. Take note of the individual product instructions for further details. Alternatively, you can dry your hearing aids in the audifon pro care Drying-Tub with an audifon Drying-
Capsule. dry star UV 2 The audifon dry star UV 2 will dry your tinnitus instruments gently yet thoroughly thanks to the constant circulation of uni-
formly warm air inside the casing. At the same time, the UVC radiation used here will kill 99.9% of all common bacteria. The audifon dry star UV 2 is not only automatic but al-
so consumes very little power, switching itself off at the end of the drying program. The drying station is simple to operate using a single sensor button. 32 33 8 DEALING WITH PROBLEMS 9 SAFETY INSTRUCTIONS If you experience any malfunctions when using your hear-
ing aids, this does not necessarily mean that they are faulty. Therefore first check your hearing aid to make sure that:
the hearing aid is switched on (see Switching on and off Section 3.4), the battery is not weak or flat, the volume is not at the lowest setting (increase the volume the right program has been set (change program if necessary), the receiver unit / earwax protection system is not blocked. slightly if necessary), If this does not eliminate the fault, consult your hearing care professional, who will be pleased to help you. NOTE: MALFUNCTIONS!
Despite their EMC-compatible design, your devices may be subject to interference from other electrical equipment. In this case move away from the source of interference. 9.1 Important warnings Warning: Risk of suffocation!
Batteries, hearing aids and other small parts can be swal-
lowed. Keep such parts out of the reach of children under 36 month years of age, the mentally disabled and pets. Should a battery, hearing aid or other small parts be acci-
dentally swallowed, please consult a doctor immediately. Warning: Risk of injury!
In very rare cases the dome may remain in the ear canal on removal. Should this happen, please contact your doctor or hearing care professional at once. Please do not try to remove the dome yourself. Warning: Damage to hearing!
The maximum volume of the tinnitus combi instrument lies in a range that can lead to hearing loss according to OSHA regu-
lations. The tinnitus combi instrument should not be used for longer than eight (8) hours, at a sound pressure level (SPL) of less than 90 dB SPL. At a higher sound pressure, the device should not be used for more than two (2) hours daily. Under no circumstances should the tinnitus combi instrument be used with a volume that is not appropriate for the user. Warning: Risk of explosion!
Do not use hearing aids in environments where there is a risk of explosion (e.g. in mines or industrial plants subject to such risk). 34 35 Warning: Risk of injury!
Hearing aids are adjusted to the individual hearing loss of each wearer and should therefore only be used by this person. If the hearing aid is worn by other persons, this may harm their hearing. Warning: Risk of injury!
Please only use genuine consumables specified by the man-
ufacturer (dome, tubing, etc.) and accessories. Unauthor-
ised changes or modifications that have not been explicitly approved may in the worst-case scenario result in injury. Warning: Interference with active and inactive implants!
If you have an active or inactive implant (e.g. defibrillator, pacemaker), follow the implant manufacturers instructions regarding use of mobile devices. In case of malfunctions, stop using your hearing aid and contact your doctor or the implant manufacturer. If you have an active brain implant, ask your doctor or the implant manufacturer for a risk analysis. Caution: Risk of injury!
Always wear the tube with the earpiece and check that the earpiece is positioned securely on the tube. Warning: Radio communications in rooms Before making a connection between radio communica-
tions and the hearing aids, you should check whether use of radio communications is restricted in the room/area. 9.2 Notes on product safety Note: Damage to hearing aid!
Hearing aids are susceptible to impact, So avoid any hard knocks (e.g. by dropping them). Note: Changes to the device No changes may be made to the hearing aids unless they are made directly by the manufacturer. Note:
To avoid damage to your hearing aids, do not wear them in the following situations:
when swimming, in the shower or bath when washing your hair or using a hairdryer when using hair spray, perfume, aftershave or body lotion during high-frequency heat therapy treatment when it is very hot or raining heavily Should your hearing aid become damp, remove the battery and dry the hearing aid in one of the drying containers speci-
fied by the manufacturer. Do not dry your hearing aid in the microwave under any circumstances. Note: Damage to hearing aid!
Do not force the battery into the battery compartment. If it does not fit, check whether you are inserting it correctly and that it is the correct type of battery. 36 37 Note: User age!
The hearing aids are not intended for children under 36 months. Reporting serious incidents!
All serious incidents related to the product that occur should be reported to the manufacturer and to the respon-
sible authorities in the member state in which the user and/
or the patient are registered. Note: Leaking batteries can damage your hearing aid!
If you are not going to use your hearing aids for a significant length of time, remove the battery to increase its life expectancy, to avoid leakage and to prevent corrosion on the battery contacts. Note: Strong radiation can damage hearing aids!
Make sure you take out your hearing aids if you are under-
going a CT or MRI scan, other magnetic field-based exami-
nations or radiotherapy. Note: Damage to hearing aid!
Never leave your hearing aid in the sun, near a naked flame or in a hot vehicle. Otherwise your hearing aids might become damaged. Note: Damage to hearing aid!
Never try to change the shape of your hearing aid, ear mould or tubing yourself. Otherwise your hearing aids might become damaged. Note: Malfunctions!
Despite their EMC-compatible design, your devices may be subject to interference from other electrical equipment. In this case move away from the source of interference. Note: Interference with electronic devices!
If you are in an environment where use of electronic or wireless devices is restricted, check if your hearing aids must be turned off. 38 39 10 SIDE EFFECTS 11 OPERATING CONDITIONS Please consult your doctor or hearing care professional at once if you notice the following symptoms:
Build-up of earwax Sensation of a foreign body Skin irritation Dizziness Vomiting Headache Pain in or behind the ear A subjective deterioration in your hearing or an increase in the tinnitus level Relative humidity between 10% and 90%
Operating temperature between 0 C and 40 C Air pressure between 500 hPa and 1100 hPa Good health practice requires a medical evaluation by a licensed physician (preferably a physician specializing in ear diseases) before recommending a hearing aid to a person with a hearing loss. Licensed physicians specializing in ear diseases are often referred to as otolaryngologists, otologists or otorhinolaryngo-
logists. The purpose of the medical evaluation is to ensure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased. 40 41 12 TRANSPORT AND STORAGE CONDITIONS 13 ENVIRONMENTALLY FRIENDLY DISPOSAL Relative humidity between 10% and 60%
Storage temperature between -20 C and 60 C Remove battery for prolonged periods of storage Store away from magnetic fields Old hearing aids and batteries must not be disposed of with your household waste. Please return old hearing aids and bat-
teries to your hearing care professional for environmentally friendly disposal. This is the person to contact in the disposal chain for electronic waste. 42 43 14 OTHER INFORMATION 14.1 EU Declaration of conformity 14.2 FCC Statement audifon hereby declares that the hearing aids lewi S and risa S comply with the following directives:
93/42/EEC for medical devices 2011/65/EU RoHs for the reduction of hazardous substances. The declaration of conformity is available for inspection at audifon GmbH & Co. KG Werner-von-Siemens-Strae 2 99625 Klleda and at www.audifon.com Federal Communications Commission Statement This device complies with part 15 of the FCC Rules. 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. NOTE:
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. These limits are designed to provide reasonable protec-
tion against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequen-
cy energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio commu-
nications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cau-
se 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 interference 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 Consult the dealer or an experienced radio/TV technician from that to which the receiver is connected. for help. 44 45 15 SERVICE Arrange for your hearing aids to be checked regularly by a hearing care professional. Arrange for your hearing aids to be checked regularly by a hearing care professional. Date Date Hearing care professional Hearing care professional Date Date Hearing care professional Hearing care professional Date Date Hearing care professional Hearing care professional 46 47 Arrange for your hearing aids to be checked regularly by a hearing care professional. Date Hearing care professional Date Hearing care professional Date Hearing care professional 48 16 KEY TO SYMBOLS Indicates a situation that may result in serious, moderate or minor injury Indicates possible damage to property Additional information for better understanding Manufacturer of the device Please do not dispose of hearing aids with your household waste. Read and observe the directions in the operating instructions. It contains important warnings and information about safety precautions. Restrict humidity Restrict temperatures This is a medical product. Item number Serial number Batch number 49 WARRANTY CARD You have chosen high-quality hearing aids from audifon. Your hearing care professional offers months warranty on our hearing aids from the date of purchase (date of invoice). The warranty covers defects in materials and manufacture. It does not cover batteries, chemical or electrochemical effects, wear and tear or mechanical damage due to improper handling. The right to claim under warranty is void if you or any unauthor-
ised third persons carry out alterations or improper repairs. Therefore always follow the safety and care instructions. Proof of purchase must be provided as proof of warranty. The date of purchase and the serial number must be clearly visible. Warranty obligations will not result in an extension of the warranty period, nor will they initiate a new warranty period for the hearing aid. The warranty period for built-in spare parts ends at the same time as the warranty period for the whole hearing aid. The warranty period for built-in spare parts ends at the same time as the warranty period for the whole hearing aid. Hearing aid type Date of sale Your hearing care professional Type Signature Stamp:
50 Serial number Warranty Name Street No. Town and postcode Telephone Date of issue R Type Serial number Warranty L Side Batterie type Side Batterie type 51 9 1 0 2
/
9 0 e t a d n o i s i v e R 0 4 0 3
-
1 4 3
-
2 0 0
-
4 7 9 3 3 0
. o n m e t I Head office audifon GmbH & Co. KG Werner-von-Siemens-Strae 2 99625 Klleda Deutschland Telephone +49-3635-4056-590
+49-3635-4056-589 Fax contact@audifon.com www.audifon.com High-tech made in Germany
1 | ext photos | External Photos | 622.47 KiB |
ANNEX B: EXTERNAL PHOTOGRAPHS EUT top view Examiner:
Date of issue: 28.02.2019 Paul NEUFELD Report Number: F181632E4 Order Number: 18-111632 page 1 of 5 ANNEX B: EXTERNAL PHOTOGRAPHS EUT bottom view Examiner:
Date of issue: 28.02.2019 Paul NEUFELD Report Number: F181632E4 Order Number: 18-111632 page 2 of 5 ANNEX B: EXTERNAL PHOTOGRAPHS EUT label Examiner:
Date of issue: 28.02.2019 Paul NEUFELD Report Number: F181632E4 Order Number: 18-111632 page 3 of 5 ANNEX B: EXTERNAL PHOTOGRAPHS EUT top view Examiner:
Date of issue: 28.02.2019 Paul NEUFELD Report Number: F181632E4 Order Number: 18-111632 page 4 of 5 ANNEX B: EXTERNAL PHOTOGRAPHS battery case open Examiner:
Date of issue: 28.02.2019 Paul NEUFELD Report Number: F181632E4 Order Number: 18-111632 page 5 of 5
1 | int photos | Internal Photos | 348.99 KiB |
ANNEX C: INTERNAL PHOTOGRAPHS EUT open*
* Photographs were provided by the applicant Examiner:
Date of issue: 28.02.2019 Paul NEUFELD Report Number: F181632E4 Order Number: 18-111632 page 1 of 4 ANNEX C: INTERNAL PHOTOGRAPHS EUT disassabled*
* Photographs were provided by the applicant Examiner:
Date of issue: 28.02.2019 Paul NEUFELD Report Number: F181632E4 Order Number: 18-111632 page 2 of 4 ANNEX C: INTERNAL PHOTOGRAPHS PCBs top view*
* Photographs were provided by the applicant Examiner:
Date of issue: 28.02.2019 Paul NEUFELD Report Number: F181632E4 Order Number: 18-111632 page 3 of 4 ANNEX C: INTERNAL PHOTOGRAPHS PCBs bottom view*
* Photographs were provided by the applicant Examiner:
Date of issue: 28.02.2019 Paul NEUFELD Report Number: F181632E4 Order Number: 18-111632 page 4 of 4
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-10-29 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2019-10-29
|
||||
1 | Applicant's complete, legal business name |
audifon GmbH & Co KG
|
||||
1 | FCC Registration Number (FRN) |
0020249033
|
||||
1 | Physical Address |
Werner-von-Siemens-Str. 2
|
||||
1 |
Koelleda, N/A
|
|||||
1 |
Germany
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
b******@phoenix-testlab.de
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
YU2
|
||||
1 | Equipment Product Code |
BT1
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
S****** T********
|
||||
1 | Title |
Engineer F&E
|
||||
1 | Telephone Number |
+49 2********
|
||||
1 | Fax Number |
+49 2********
|
||||
1 |
s******@audifon.com
|
|||||
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 | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Hearing Aid with BLE | ||||
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 | Grant Comments | Output power listed is max conducted. | ||||
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 |
PHOENIX TESTLAB GmbH
|
||||
1 | Name |
H**** B********
|
||||
1 | Telephone Number |
49-52********
|
||||
1 | Fax Number |
49-52********
|
||||
1 |
o******@phoenix-testlab.de
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0014000 |
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