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USER INSTRUCTIONS THE CLEAR™440 SERIES

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1. al listening program called Zen It makes musical tones and sometimes a rushing noise in the background us ing the latest in fractal technology These sounds are shaped according to your hearing loss so you can listen to them at any time and at any place with a simple push of the program button The Zen program may be used alone without amplification in quiet when you are not required to hear surrounding sounds Or it may be used with another program so both the surrounding sounds and the generated sounds fractal tones and noise are heard together 20 A CAUTION Use of the different Zen programs may interfere with hearing surrounding sounds including speech The programs should not be used when hearing such sounds is important Switch the hearing aid to a non Zen program in those situations A CAUTION If you perceive decrease in loudness tolerance of sounds speech not as clear or worsening tinnitus contact your hearing care professional The duration of the Zen play time can be set by your hearing care professional according to your needs Benefits The Zen program may provide a relaxing listening background for some people When the Zen program is used in a tinnitus management program its wearer may experience some relief from tinnitus Indications for use The Zen program is intended to provide a relaxing sound background i e music noise source for adults who desire to listen to such a backg
2. mote unit tween hear tween PC hearing aid to hearing ing aid and and lt 30 cm be aid TM DEX NOAHlink tween hear ing aids or Hearing aid to TM DEX Center 10 6 MHz 10 6 MHz 10 6 MHz 2 4 GHz frequency 38 Hearing RC DEX TM DEX Bluetooth aids NOAHIink Channel Single Single Single 5 logical channel channel channel channels radio radio radio Band 660 kHz 660kHz 660kHz 1MHz width 15 dB 15 dB 15 dB Data rate 212 kbit 212 kbit 212 kbit 2 1 Mbps second raw second second raw channel raw channel capacity channel capacity capacity Data flow Simplex or Simplex Simplex or Time divi semi duplex capability semi duplex sion duplex capability capability TDD Protocol Random Random Random Packet Access no Access Access no based pro collision no colli collision tocol time avoidance sion avoidance divided se avoidance cure Serial Port Profile SPP Bluetooth specification v2 0 EDR published by the Bluetooth Special Interest Group SIG EIRP Equivalent isotropically radiated power Bluetooth Identifier BO1837 Reference number of QPN NOAHIlinkV1 2_412832_QPN_E1 39 Benefits The use of wireless transmission allows convenient and synchronized control of hearing aid functions The CLEAR wireless hearing aids share input information between the two partner hearing aids In so doing the wearers woul
3. consult your hearing care professional If you have a remote control please also refer to the user instructions for this Aree With a custom earmould this hearing aid is capable of pro ducing a sound pressure level exceeding 132 dB SPL There may be a risk of damaging your residual hearing A CAUTION If the volume in the hearing aid is generally too loud or too weak or the reproduced sounds are distorted or if you would like any further information consult your hearing care profes sional To mute the hearing aid with a remote control Keep pressing the volume down key on the remote con trol after the long beep tone has sounded and until it stops Pressing one of the volume keys briefly will bring back the sound Lost partner alarm Note Only applicable if this feature has been activat ed by your hearing care professional If one of your hearing aids falls off your ear and or the battery is exhausted a tone signal and a spoken mes sage will sound two times in the other hearing aid and the diode will flash on both hearing aids When the lost hearing aid is repositioned and or the battery is exchanged the diodes stop flashing Listening programs Your hearing aid may be provided with five of the fol lowing programs plus either the special Zen program called Zen or the Phone program Master Standard Music For listening to music TV For listening to the
4. ear communication between hearing aids a BER better than 10 is required The communication is updated every 50 ms or 20 Hz The hearing aids continue to amplify based on the last saved settings even when the transmission range is exceeded or when communication is interfered 43 Wireless Security Measures Security of the wireless signals is assured through device system design that includes e Individual MAC address for each unit which is checked during each transmission e A built in pairing table which specifies valid and legitimate pairing among units e A proprietary Widex communication protocol which checks the package numbers during each transmission e A Cyclic Redundancy Check CRC to check data validity and correct errors 44 GUIDANCE AND MANUFACTURER S DECLARATION Electromagnetic emissions The CLEAR series hearing aids are intended for use in the elec tromagnetic environment specified below The customer or the user of a CLEAR series hearing aid should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 2 The CLEAR hearing aid must CISPR 11 emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions Class B The CLEAR hearing aid is suit CISPR 11 able for use in all establish ments including domestic es one a tablishment
5. only one orientation that represents the longest length or worst case scenario This is acceptable because of the relative small size of the device compared to the wavelength of the RF used in the test 52 IMPORTANT NOTICE FOR PROSPECTIVE HEARING AID USERS Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician preferably a physician who specializes in diseases of the ear before purchasing a hearing aid Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists otologists or otorhinolaryngologists The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hear ing are identified and treated before the hearing aid is purchased Following the medical evaluation the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid The physician will refer you to an audiologist or a hearing aid dispenser as appropriate for a hearing aid evaluation The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hear ing aid The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid to your individual needs If you have reservations about your ability to adapt to amplifica tion yo
6. signal can also be deactivated Adjusting volume Tone off via remote control Click Confirming program button use ing Off sound Changing program Message Tones Off Starting up the hearing aid Message Tone Off Warning about low battery Message 4 tones Off Warning about lost partner Message Off Service reminder Message Off Bold indicates standard setting The battery We recommend zinc air batteries Use a size 312 bat tery for the hearing aid To obtain replacement batteries please consult your hearing care professional It is important to take note of the expiration date and the recommendations on the battery pack regarding disposal of used batteries Oth erwise there is a risk that the battery life may be re duced Inserting the battery Before inserting a new battery into the hearing aid remember to remove the adhe sive tab Once the tab has been removed the battery will start functioning after a few seconds A CAUTION Do not use batteries if there is a sticky residue from the tab or other unwanted substance as this can cause the hearing aid to malfunction Use the nail grip to gently swing the o battery drawer completely open Do not press the drawer beyond the open position Place the battery in the drawer so that the plus sign on the battery faces upward You can use the battery magnet provided to steer the battery into place If
7. the battery drawer does not close easily the battery is incorrectly inserted When changing battery it is a good idea to hold the hearing aid over a table The hearing aid may be provided with a battery drawer without a nail grip which means that you need a tool to open the battery drawer This type of drawer can be a good choice if the hearing aid is worn by a child A special tool for opening the drawer will be in cluded with this drawer The battery drawer is opened as illus trated Low battery indication An acoustic indicator will sound when the battery is nearly exhausted unless this function has been dis abled see page 8 We recommend that you al ways have a spare battery with you LA Never leave an exhausted battery in the hearing aid Exhausted batteries may leak damaging the hearing aid LN warkine Your hearing aid may stop functioning for instance if the battery is exhausted You should be aware of this possibility in particular when you are in traffic or are otherwise dependent on warning signals Turning the hearing aid on and off The battery drawer of the hearing aid also functions as the on off switch Close the battery drawer to turn on a the hearing aid An acoustic indicator will indicate that the hearing aid has been switched on unless this function has been disabled To turn off the hearing aid open the battery drawer slightly to the first po sition where a cli
8. the hearing aid will not be used for several days e When the hearing aid is not in use keep it in its case in a cool dry location out of reach of children and pets Do not expose the hearing aid to extreme temperatures or high humidity Make sure to dry the hearing aid thoroughly after heavy perspiration such as that which may occur during intense physical activity e g playing sports Avoid dropping your hearing aid perform cleaning and bat tery changes while holding the hearing aid above a soft sur face Do not wear your hearing aid while in the shower or swim ming or when using a hair dryer perfume hair and body sprays or gels such as suntanning lotions or creams In environments with high humidity a drying kit may be used daily to reduce the amount of moisture inside the hearing aid See the instructions enclosed with the drying kit 33 WARNINGS A WARNING Hearing aids and batteries can be dangerous if swallowed or used improperly Swallowing or improper use can result in severe injury or even fatalities In case of ingestion contact a physician immediately and the 24 Hour National Button Bat tery Ingestion Hotline at 202 625 3333 e Keep hearing aids and their parts accessories and batter ies out of reach of children and anyone else who might swal low such items or otherwise cause injury to themselves Do not change batteries in front of them and do not let them see where you keep yo
9. BOLS The following symbols will be used throughout the manual LN wiser Messages with this heading indicate serious adverse reactions potential safety hazards and inadequate performance of device A CAUTION Messages with this heading indicate include information regard ing any special care to be exercised Co Non ionizing radiation Him Not for general waste THE HEARING AID The illustration below shows the hearing aid without the ear set The choice of ear set solution depends on your specific needs Please refer to the separate ear set user manual 1 On off switch 2 Battery drawer with nail grip 3 Program button 4 LED amp Right Left ID NOTE In addition to these user instructions a separate user manual is provided describing the various ear set solutions available for your hearing aid Ear sets for Widex BTE hearing aids Aie This booklet and the manual Ear sets for Widex BTE hearing aids contain important information and instructions Read these booklets carefully before you start using the hearing aid NOTE Your hearing aid ear set and accessories may not look exactly as illustrated in this booklet We also reserve the right to make any changes considered necessary Intended use The CLEAR hearing aids are intended as air conduction amplification devices to be used in everyday listening environments The CLEAR hearing aids may be provid ed with the Zen program in
10. TV Comfort Attenuates background noise Reverse focus Focus on sounds from behind Audibility Extender Makes high frequency sounds audible Phone For listening to the telephone T In this program you listen via the telecoil T and not via the hearing aid microphones M The telecoil is used where a loop system is installed If you activate the telecoil program you listen to a specific sound source and shut out surrounding sounds M T In this program you listen via the hearing aid microphones M and the telecoil T Zen Generates different kinds of tones Compound programs The Master program in one ear and Zen Reverse focus Audibility Extender T MT or Phone in the other Zen Special Zen program with up to three different Zen styles Phone For phone use only Transmits the telephone sound received in one hearing aid to the other hearing aid Note that the microphones on the hearing aid to which the sound are transmitted is turned off If your needs change over time the combination of lis tening programs can be altered A CAUTION When selecting Phone as listening program please remember that there are situations in which it is particularly important to be able to hear the surrounding sounds Zen program Your hearing aid may be provided with a unique option
11. These guidelines may not apply in all situations Electro magnetic propagation is affected by absorption and reflection from structures objects and people This CLEAR hearing aid may be interfered with by other equip ment even if that other equipment complies with CISPR emission requirements 51 EMI EMC Compliance The CLEAR hearing aid complies with the following EMC EMI standards Standard Test type Note 47 CFR Part RFemissions USA Federal Communications 15 subpart C Commission FCC require ments for intentional radiators EN 303 330 2 RF emissions EMC and radio spectrum mat V1 3 1 incl Spurious ters for Short Range Devices in emission the frequency range 9 kHz 25 MHz IEC 60601 1 EMC emission Medical electrical equipment 2 2007 Immunity RF General requirements for basic adapted and ESD safety and essential perform protocol ance Electromagnetic compatibility EN 301 489 3 Immunity RF Standard for Low Power Trans V1 4 1 and ESD mitters in the frequency range 9 kHz 40 GHz IEC 60118 Immunity International Product std for 13 2004 RF Near Field hearing aids to ensure adequate immunity test immunity to radio interference from cell telephones ANSI C63 19 Immunity American National Standard 2001 RF Near Field Methods of measurement of immunity test Compatibility between wireless Communication Devices and Hearing Aids The device was tested in
12. WIDEX CLEAR 440 STAY IN SYNC WITH LIFE USER INSTRUCTIONS THE CLEAR 440 SERIES C4 FS model RIC RITE Receiver in canal Receiver in the ear YOUR WIDEX CLEAR 440 HEARING AID To be filled out by the hearing care professional Date Battery size CONTENTS SYMBOLS ni memes denvanmeedtemienes came AAEE 4 THE HEARING AID scsi season ect en ses done 5 Right left identification rss 8 Acoustic indicators RER BGG a URL Eee 8 Th Datter o skis cee adi 9 Inserting the batterV sssessscesusmersmmeueuuvusus 9 Low battery indication 12 Turning the hearing aid on and off 13 Positioning the hearing aid 14 Removing the hearing aid 15 Volume ACjUSIMENC 23 424 eee 16 Lost partner alai Mesi ireti rennan denna nana 18 Listening PFOQKAIMS creer ananas 448 19 Switching between the listening programs 25 ZENE erens deu bee deee anaa a a aa a 26 PhONG Esus num cextoweeeee sai SR ARR aa 26 Using a telephone 27 Cleaning en ee aniemene Dirt ce told 28 ACCESSORIES css sois nnrir eee okra Bree sue nn es anes 30 IN CASE OF MALFUNCTION 31 CARING FOR YOUR HEARING AID 33 WARNINGS casse means ennemie adieu 34 ADVICE sue nd nas nn enr ce dues ant 37 REGULATORY INFORMATION 38 SYM
13. aring aid parts Do not under any circumstances use alcohol chlorine or similar substances Do not use Widex hearing aids in mines or other areas with explosive gases 35 A WARNING Do not wear your hearing aid during radiation X rays MRIs CT or other medical treatments and scans The emissions from these procedures as well as from other types of radia tion such as that in a microwave oven can damage your hear ing aid Radiation from for example room surveillance equip ment burglar alarms and cell phones is weaker and will not damage the hearing aid but may create audible interference A CAUTION e Your hearing aid has been tested for interference according to international standards Nevertheless it is possible that unforeseen interference may occur in the hearing aid due to electromagnetic radiation from other products such as alarm systems room surveillance equipment and cell phones Although your hearing aid has been designed to comply with the most stringent international electromagnetic compatibil ity standards the possibility cannot be excluded that it may cause interference with other equipment such as medical de vices e Never try to open or repair the hearing aid yourself 36 ADVICE NOTE The hearing aid will not restore normal hearing and will not prevent or improve a hearing loss resulting from organic conditions However the hearing aid can help you to make
14. ce 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 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 interference 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 interference by one or more of the following measures Reorient or relocate the receiving antenna 55 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 experienced radio TV technician for help NOTE This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment This transmitter must not be co located or operating in conjunction with any other antenna or transmitter Changes or modifications to the equipment not expressly approved by Widex could void the user s authori
15. ck is felt Please remember to turn off the hearing aid when it is not in use Remove the battery if the hearing aid will not be used for several days Positioning the hearing aid Insert the earpiece in the ear canal while holding the lower part of the earwire It may help to pull the out er ear backwards and upwards with the opposite hand Place the hearing aid behind the ear so that the hear ing aid and earwire rest comfortably on the ear close to your head The illustrations show an open ear tip For further infor mation on ear tip earmould types anchors and proce dures see the separate ear set user manual provided Removing the hearing aid Remove the hearing aid from its position behind the ear Carefully pull the earpiece out of the ear canal while holding the lower part of the earwire If the earpiece is provided with an extraction cord take hold of this and carefully pull the ear tip out of the ear canal Volume adjustment The hearing aid volume is adjusted automatically in ac cordance with your sound environment If you have a remote control you can also adjust the volume manually or mute your hearing aid Any adjust ment of the volume setting will be cancelled when your hearing aid is turned off or when you change program In the default setting any volume adjustment via the remote control will affect both hearing aids To alter the increments in which the volume is increased or decreased
16. d experience the following additional user benefits only when wearing binaural CLEAR hearing aids Synchronization of volume control settings between hearing aids The volume in both hearing aids will change when the VC is adjusted on one ear Synchronization of listening programs between hearing aids The same listening program is used in both hearing aids when one is changed by the user Surveillance of partner hearing aid The hearing aid s will signal an alert partner check when a hearing aid battery has expired or that one of the hearing aids has fallen off In rare instances a much stronger wireless source nearby may activate this alert This serves as an early warning to the wearer of such service interrup tion Coordination of compression The CLEAR hearing aids maintain the intensity level difference between ears inter aural level dif ference ILD In some situations where speech is presented to one side and noise the other side this coordinated action could enhance the relative loudness of the speech sounds to the noise background and improve speech understanding for some wearers More accurate identification of feedback The CLEAR hearing aids distinguish between true hearing aid whistling or feedback and music sounds to prevent unnecessary feedback cancellation and preserve natural sound quality 40 Contraindications Congenital or traumatic deformity of the ear Active drainage fro
17. e L exploitation est autoris e aux deux conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l utilisateur de l appareil doit accepter tout brouillage radio lectrique subi m me si le brouillage est susceptible d en compromettre le fonctionnement 57 CE 0459 Hereby Widex A S declares that this C4 FS is in com pliance with the essential requirements and other rele vant provisions of Directive 1999 5 EC A copy of the Declaration of Conformity can be found at http www widex com N26346 58 Hearing aids accessories and batter ies should not be disposed of with nor mal household waste Please consult your national Widex distributor for advice on how to dispose of these items 59 Me A Manufacturer C WIDEX A S Nymoellevej 6 DK 3540 Lynge 0459 Denmark www widexusa com CIB205 110 TAN sxe sos 9 514 0165 041 03
18. gram 2 Message or two short beeps Program 3 Message or three short beeps Program 4 Message or one long and one short beep Program 5 Message or one long and two short beeps Zent Message or tone or Phone Message or tone In the default setting both your hearing aids will be af fected when you change programs 25 Zen This program is accessed via a long press two secs on the program button on the hearing aid or the RC DEX short press then allows you to cycle through the available Zen styles You can exit Zen by pressing and holding the program button for two seconds Phone This program is accessed via a long press two secs on the program button on the hearing aid You can exit Phone by pressing and holding the same program button for two seconds If you wish to have the program button disabled please consult your hearing care professional 26 Using a telephone When using a telephone we recommend that you hold the telephone against your head at an angle above your ear rath er than directly against the ear If the sound is not optimal try moving the telephone earpiece to a slightly different position 27 Cleaning The following cleaning accessories are available for the hearing aid and ear set For cleaning the ear set see the user manual Ear sets for Widex BTE hearing aids 1 Cloth 2 Wax removing tool 3 Brush Contact your hearing care professional if you need ad ditiona
19. ing may Contact your hearing have changed care professional The hearing Your ear is blocked Contact your ENT doc aid whistles by earwax tor physician continuously 31 Problem Potential cause Solution Your two The connection be Turn the hearing aids hearing aids tween the hearing off and on again are not work aids is lost ing in syn chrony The hearing a The DEX is used a Move the DEX closer aids do not beyond the trans to the CLEAR hearing respond with a correspond mission range b Strong electro aids b Move away from ing change in magnetic interfer known source of EM volume or ence in the vicini interference program to ty the DEX c The DEX andthe c Check with dispenser CLEAR hearing to make sure DEX is aids are not matched with CLEAR matched hearing aids You hear a The battery in one a Replace battery in interrupted of the hearing aids one or both hearing speech on has expired aids and off from b Strong electro b Move away from the hearing magnetic interfer known sources of in aids or no ence in the vicini terference speech mut ed from the transmitting ear ty 32 CARING FOR YOUR HEARING AID The hearing aid is a valuable object and should be treated with care Here are some things you can do to prolong the life of your hearing aid A CAUTION e Turn off your hearing aid when it is not in use Remove the battery if
20. l supplies of cleaning accessories Selection depends on your ear set solution 28 Clean the hearing aid with the soft cloth after use Laine Never use water or cleaning solutions to clean the hearing aid as this may cause it to malfunction When the hearing aid is not in use the battery drawer should be left open to ventilate the hearing aid and allow it to dry 29 ACCESSORIES A variety of assistive listening devices are available for your hearing aid e RC DEX e TV DEX e M DEX For help in determining whether you could benefit from a remote control or other accessories please consult your hearing care professional 30 IN CASE OF MALFUNCTION The following pages contain some quick advice on what to do if your hearing aid stops working or performs un satisfactorily If the problems persist contact your hearing care professional for assistance See the Ear sets for Widex BTE hearing aids user manual for information specific to your ear set Problem Potential cause Solution The hearing The hearing aid is Make sure the battery aid is com not turned on drawer is completely pletely silent closed The battery does not Insert a new battery in work the hearing aid The hearing The battery is nearly Insert a new battery in aid volume is exhausted the hearing aid not powerfu enough Your ear is blocked Contact your ENT doc by earwax tor physician Your hear
21. m the ear within 90 days e History of rapid progressive hearing loss within previous 90 days e Acute or chronic dizziness e Sudden unilateral hearing loss in previous 90 days A CAUTION Risks The use of the CLEAR DEX should not interfere with other devices such as a pacemaker However to be extra cau tious Widex follows the guidelines recommended by the manu facturers of implantable defibrillators and pacemakers for their patients when using cell phones Specifically hearing aid wear ers who also use a pacemaker should e Keep the hearing aids at a distance of at least 15 cm 6 inches away from the pacemaker and Do not carry the hearing aids and or any of the DEX accesso ries in a shirt pocket or close to the chest e If any interference is observed do not use the hearing aids and or DEX and contact your pacemaker manufacturer and hearing healthcare professional immediately 41 RADIO TRANSMITTER CABLES TRANSDUCERS The CLEAR series hearing aid contains a radio transmitter receiver with the following Radio transmitter parameters Frequency range 10 6 MHz 10 2 11 0 MHz e Bandwidth 15dB 660 kHz e Channel Single channel radio e Modulation FSK e Radiated output power 29 pW 75 dBm e Magnetic field strength 54 dBuA m 10 m e Duty Cycle lt 5 averaged over 1 hour of operation Simplex or semi duplex capability The radio receiver in the CLEAR series hearing aid i
22. r sup 60 dip ply input in U for 5 lines cycles IEC 70 U 61000 4 1 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5s Power fre 3 A m 3 A m Power frequency quency magnetic fields 50 60 Hz should be at lev magnetic els characteristic field of a typical loca IEC tion in a typical 61000 4 8 commercial or hospital environ ment NOTE U is the a c mains voltage prior to the application of the test level Battery powered equipment 47 Electromagnetic immunity cont The CLEAR series hearing aids are intended for use in the elec tromagnetic environment specified below The customer or the user of a CLEAR series hearing aid should assure that it is used in such an environment Immunity IEC 60601 Compli Electromagnetic environ Test Test level ance level ment guidance Portable and mobile RF communications equip ment should be used no closer to any part of the CLEAR series hearing aid including cables than the recommended separa tion distance calculated from the equation applica ble to the frequency of the transmitter Recommended separation distance Conducted 3 Vrms 3 Vrms d 1 2 VP RF IEC 150 kHz to 61000 4 6 80 MHz Radiated 3 V m 3 V m d 1 2 VP RF 80 MHz to 800 MHz IEC 80 MHzto d 2 3vP 61000 4 3 2 5 GHz 800 MHz to 2 5 GHz 48 Immunity Test IEC 60601 Test level Compli ance level Elect
23. ries hearing aid b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances Recommended separation distances between portable and mobile RF communication equipment and the CLEAR series hearing aids The CLEAR series hearing aids are intended for use in the elec tromagnetic environment in which RF disturbances are controlled The customer or the user of the CLEAR series hearing aid can help prevent electromagnetic interference by maintaining a mini mum distance between portable and mobile RF communications equipment transmitters and the CLEAR hearing aids as recom mended below according to the maximum output power of the communications equipment 50 Rated maximum Separation distance according to frequency output power of of transmitter m transmitter 150kHzto 80 MHzto 800 MHz to W 80MHz 800 MHz 2 5 GHz d 12VP d 12VP d 2 3 VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manu facturer NOTE 1 At 80 MHz and 800 MHz the higher frequency range ap plies NOTE 2
24. romagnetic environ ment guidance Where P is the maximum output power rating of the transmitter in watts W according to the transmit ter manufacturer and d is the recommended separa tion distance in meters m Field strengths from fixed RF transmitters as deter mined by an electromag netic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co 49 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Elec tromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the CLEAR series hearing aid is used exceeds the applicable RF compliance level above the CLEAR series hearing aid should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or re locating the CLEAR se
25. round in quiet It may be used as a sound therapy tool in a tinnitus treat ment program that is prescribed by a hearing care pro fessional audiologists hearing aid specialists otolar yngologists who is trained in tinnitus management 21 Directions for use The Zen program can be activated with a simple push of the program button on the hearing aid or on the remote control Depending on how your hearing care professional has set up the program you can access the Zen program by a short press of the program button or a long press of the program button e Short press option the program button is pressed for less than a second At most two listening pro grams can be programmed for Zen e Long press option the program button is pressed and held for more than 1 second Up to three Zen styles are available A short press of the program button in the long press mode will allow you to cy cle through the available Zen styles You can exit the long press mode by pressing and holding the pro gram button for more than a second Because of the unique ways in which Zen is pro grammed in your hearing aid please follow the rec ommendations of your hearing care professionals as to how to use the program when to use the program and or how long to use the program 22 Precautions To ensure the safety and effectiveness of the Zen pro gram when used as a sound therapy tool for tinnitus the tinnit
26. s and those directly IEC 61000 3 2 connected to the public low voltage power supply net Voltage fluctu Not work that supplies buildings ations flicker applicable used for domestic purposes emissions IEC 61000 3 3 Battery powered equipment 45 Electromagnetic immunity The CLEAR series hearing aids are intended for use in the elec tromagnetic environment specified below The customer or the user of a CLEAR series hearing aid should assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic Test Test level level environment guidance Electrostatic 6 KV con 6 kV contact Floors should be discharge tact 8kV air wood concrete ESD 8kV air or ceramic tile If IEC floors are cov 61000 4 2 ered with syn thetic material the relative hu midity should be at least 30 Electrical 2 kV for Not Not fast tran power line applicable applicable sients burst supplies IEC 1kV forin Not 61000 4 4 put output applicable lines Surge 1kV line s Not Not IEC to line s applicable applicable 61000 4 5 2 kV line s Not to earth applicable 46 Immunity IEC 60601 Compliance Electromagnetic Test Test level level environment guidance Voltage lt 5 U Not Not dips short gt 95 dip applicable applicable interruptions in UD for and voltage 0 5 cycle variations on 40 U powe
27. s using the same frequency and bandwidth as the transmitter Co Cables and transducers No cables and transducers are used neither during normal use of the CLEAR series hearing aid nor during programming of the hearing aid 42 QUALITY OF SERVICE FOR WIRELESS TECHNOLOGY IN THE WIDEXLINK SYSTEM WidexLink wireless technology enables communication between two partners of a binaural pair of CLEAR hearing aids and with their matched external devices The requirements for the quality of service QoS vary among the various components and their intended user scenarios For programming these requirements include a BER Bit Error Rate better than 10 at a bitrate of 212 kbits s a semi duplex transmission with a required acknowledge a transmission latency in each direction 2x and a receive to transmit mode RX to TX time The data are saved in the hearing aid even when transmission is interrupted During daily use the requirements on audio streaming between hearing aids include a BER better than 10 The communication is simplex with a bitrate of 212 kbits s The additional audio decod ing in this mode results in a longer latency which is less than 10 ms For remote control commands the QoS requirements include a BER better than 102 The lower BER requirement results from re dundant transmissions Each key press results in transmissions of 7 data packages of which only one is needed for a successful com munication For inter
28. tended to provide a relaxing sound background i e music noise source for adults who desire to listen to such a background in quiet Indications for use The devices are indicated for individuals with a full range of hearing loss severity from slight 16 dB HL to 25 dB HL to severe profound 90 dB HL and all hear ing loss configurations They are to be programmed by licensed hearing care professionals audiologists hearing aid specialists oto laryngologists who are trained in hearing re habilita tion as well as tinnitus management Description of device Your CLEAR hearing aid is used with an ear set which consists of an earwire and an earpiece in which the receiver is placed The hearing aid uses a proprietary wireless technology WidexLink to enable communica tion between the left and the right hearing aids as well as between the hearing aids and the DEX accessories Your hearing aid may be provided with an optional lis tening program called Zen It makes musical tones and sometimes a rushing noise in the background These sounds are shaped according to your hearing loss Right left identification The arrow shows the position of the identification mark red right and blue left Acoustic indicators The hearing aid may be set to produce a signal to indi cate the use of certain functions The signal may be a spoken message or tones adjusted by the hearing care professional in consultation with you The
29. the best possible use of your remaining hearing ability You should also bear in mind that it can take time to get used toa new hearing aid and new sounds In most cases using the hearing aid infrequently will not per mit you to gain full benefit from it The use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading The use of hearing aids increases the risk of accumulation of earwax Contact your physician ENT doctor if you suspect that a plug of earwax has accumulated in your ear Earwax may not only reduce your own hearing but also the effect of the hearing aid considerably It is a good idea to ask your phy sician to clean your ears a couple of times a year 37 REGULATORY INFORMATION The following Table summarizes the technical details of the WidexLink technology as it is implemented in the CLEAR hearing aids Hearing RC DEX TM DEX Bluetooth aids NOAHlink Antenna Inductive Inductive Inductive Embedded type antenna antenna antenna ceramic an tenna Antenna 1 8 mm 98 mm 96 mm NA dimen L 4 85 mm L 20mm L 8mm sions Modula FSK FSK FSK FHSS tion GFSK 1 4 DPSK 8 DPSK Magnetic 54 13 26 NA Field dBuA m dBuA m dBuA m Strength at10 m distance Output 29 pw 21 nW 1 2 nW 4dBre power ImW EIRP Range lt imre lt imre lt 30 cm be lt 10 m be mote unit to
30. ty to operate the equipment Industry Canada Statement D claration d industrie Canada Under Industry Canada regulations this radio transmitter may only operate using an antenna of a type and maximum or lesser gain approved for the transmitter by Industry Canada To reduce potential radio interference to other users the antenna type and its gain should be so chosen that the equivalent isotropically radiated power e i r p is not more than that necessary for successful communication 56 This device complies with Industry Canada licence exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Conform ment a la r glementation d Industrie Canada le pr sent metteur radio peut fonctionner avec une antenne d un type et d un gain maximal ou inf rieur approuv pour l metteur par Industrie Canada Dans le but de r duire les risques de brouillage radio lectrique l intention des autres utilisateurs il faut choisir le type d antenne et son gain de sorte que la puissance isotrope rayonn e quivalente p i r e ne d passe pas l intensit n cessaire l tablissement d une communication satisfaisante Le pr sent appareil est conforme aux CNR d Industrie Canada applicables aux appareils radio exempts de licenc
31. u should inquire about the availability of a trial rental or purchase option program Many hearing aid dispensers now offer programs that permit you to wear a hearing aid for a period of time for a nominal fee after which you may decide if you want to purchase the hearing aid Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician Federal law permits a fully informed adult to sign a waiver state ment declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician The exercise of such a waiver is not in your best health interest and its use is strongly discouraged 53 Children with hearing loss In addition to seeing a physician for a medical evaluation a child With a hearing loss should be directed to an audiologist for evalu ation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss 54 FCC ID TTY C4FS IC 5676B C4FS 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 interferen
32. ur battery supply Discard used batteries carefully e Batteries are very small and can easily be mistaken for pills or the like Never put a battery or hearing aid in your mouth for any reason as you may risk swallowing it 34 Linni e Risk of explosion if battery is replaced by an incorrect type or recharged Dispose of used batteries according to the in structions e Never allow others to wear your hearing aid as this could cause permanent damage to their hearing e When selecting a listening program please remember that there are situations in which it is particularly important to be able to hear the surrounding sounds e g traffic warning sig nals The hearing aid is made of modern non allergenic materials Nonetheless in rare cases skin irritation may occur If you no tice skin irritation in or around your ear or ear canal contact your hearing care professional Be aware that the use of any type of hearing aid may involve a slightly increased risk of infection in the ear canal An infec tion can arise as a result of inadequate ventilation of the ear We therefore recommend that you remove the hearing aid and ear set from your ear at night to allow the ear canal to be ventilated Make sure that you clean and inspect your hearing aid and ear set as required If an infection occurs you should seek medical attention and contact your hearing care profes sional for advice on how to disinfect the various he
33. us management program must be designed and conducted by hearing care professionals who are trained in tinnitus management A tinnitus manage ment program should include a complete audiological evaluation tinnitus diagnosis counseling use of proper amplification and or sound therapy tools Prior to any tinnitus management program it is advis able that you seek medical attention to exhaust any medical or surgical treatment options Use your hearing aid and the Zen program according to the directions and schedule recommended by your hearing care professionals Warnings Use of the Zen program may interfere with hearing eve ryday sounds including speech It should not be used when hearing such sounds is important Switch the hearing aid to a non Zen program in those situations 23 Risks There are no known risks or side effects associated with the use of the Zen program However consistent with our recommendations on the use of conventional hear ing aids stop using the hearing aids and the Zen pro gram and seek attention from your hearing care pro fessional if any of the following symptoms are noted e Skin irritation Perceived decrease in loudness tolerance of sounds speech not as clear or worsening tinnitus 24 Switching between the listening programs Each time you switch to another program an acoustic indicator will sound unless this function has been disa bled Program 1 Message or one short beep Pro

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