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User Instructions - D-FA Model - Elite Audiology & Hearing Care, PLLC

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Contents

1. 13 Positioning the hearing aid 14 Removing the hearing aid 15 Volume adjustment 16 Lost partner alarm 18 Brograrmiss kis ad Leser dE Ede Pde adh othe bade 18 Switching between the listening programs 24 ZONE cs den HE ts tes mit E 25 Phones o nuni disi te RR mis 25 Using a telephone 26 CLEANING cesio Cx 50 7 The hearing aid vaccine oneal a beaten 28 ACCESSORIES Li SAR ie eee ad EC das 29 IN CASE OF MALFUNCTION 30 CARING FOR YOUR HEARING AID 32 WARNINGS 33 7 7 Adapting to your hearing 81685 0c eee 38 REGULATORY INFORMATION 40 ADDITIONAL PROGRAM FORM 60 SYMBOLES nina hr 5 ce 9e mL ess 61 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 Microphone openings Volume control Program button On off switch Battery drawer with nail grip LED oU NOTE In addition to these user instructions a separate user manual is provided describing the various ear set solutions available for your hearing aid
2. Alert The product is identified by R amp TTE Directive 1999 5 EC as an equipment Class 2 product with some restrictions on use in some CE member states C C Tick mark The product complies with EMC and radio spectrum regulatory requirements for products supplied to the Australian or New Zealand market ko Interference Electromagnetic interference may occur in the vicinity of the product The six or seven digit number on the product is the serial num ber Serial numbers may not always be preceded by SN 63 WIDEX A S Nymoellevej 6 DK 3540 Lynge Danemark www widex com Manual no C 9 514 0247 02 0459 973 14024 704109 Aa 2 WIDEX DREAM and DEX are trademarks of Widex A S 9 J From responsible FSC sources wmwiscog FSC C068122
3. Battery powered equipment 47 Electromagnetic immunity The DREAM series hearing aids are intended for use in the elec tromagnetic environment specified below The customer or the user of a DREAM 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 8 air wood concrete ESD 8 kV 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 2kV 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 48 Immunity IEC 60601 Compliance Electromagnetic Test Test level level environment guidance Voltage 5 96 U Not Not dips short gt 95 96 dip applicable applicable interruptions in Up for and voltage cycle variations on 40 U power sup 60 dip ply input in U for 5 lines cycles IEC 70 U 61000 4 11 30 dip in U for 25 cycles 5 96 U gt 95 dip in U for 5 Power fre 3 A m 3 A m Power frequency quency magnetic fields 50 60 Hz sh
4. 44 QUALITY OF SERVICE FOR WIRELESS TECHNOLOGY IN THE WIDEXLINK SYSTEM WidexLink wireless technology enables communication between two partners of a binaural pair of DREAM hearing aids and with their matched external devices The requirements for the quality of service QoS vary among the various components and their in tended 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 transmis sion 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 107 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 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 rang
5. 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 51 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 radi os amateur radio AM and FM radio broadcast and TV broad cast 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 mea sured field strength in the location in which the DREAM series hearing aid is used exceeds the applicable RF compliance level above the DREAM series hearing aid should be observed to ver ify normal operation If abnormal performance is observed addi tional measures may be necessary such as re orienting or re lo cating the DREAM series 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 mo bile RF communi
6. 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 GPN NOAHlinkV1 2 412832 QPN 41 Benefits The use of wireless transmission allows convenient and synchronized control of hearing aid functions The DREAM wire less hearing aids share input information between the two part ner hearing aids In so doing the wearers would experience the following additional user benefits only when wearing binaural DREAM hearing aids Synchronization of volume control settings between hearing aids The volume in both hearing aids will change when the VC is ad justed 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 sig nal an alert partner check when a hearing aid battery has ex pired or that one of the hearing aids has fallen off In rare instanc es amuch stronger wireless source nearby may activate this alert This serves as an early warning to the wearer of such service in terruption Coordination of compression The DREAM hearing aids main tain the intensity level difference between ears inter aural level difference ILD In some situations where speech is presented to one side and noise
7. Ear sets for Widex BTE hearing aids AN 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 hearing aids are intended as air conduction amplifi cation devices to be used in everyday listening environ ments The hearing aids may be provided with the Zen program intended to provide a relaxing sound back ground 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 range of hearing loss severity from minimal 10 dB HL to se vere to profound 100 dB HL and all hearing loss con figurations 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 hearing aid is used with an ear set which consists of a tube and an ear tip or earmold The hearing aid uses a proprietary wireless technology WidexLink to enable communication between the left and the right hearing aids as well as between the hearing aids and the DEX accessori
8. RC DEX TM DEX Bluetooth NOAHlink Antenna Inductive an Inductive Inductive an Embedded type tenna antenna tenna ceramic an tenna Antenna di 1 8 mm 08mm 6 mm NA mensions L 4 85 mm L 20 mm L 8mm Modulation FSK FSK FSK FHSS GFSK n 4 DPSK 8 DPSK Magnetic 54 dBuA m 13 26 dBuA m NA Field dBuA m Strength at 10 m dis tance Output 29 pW 21nW 1 2 nW 40 re power ImW EIRP Range 1mremote 1mre lt 30cmbe 10 m be unit to hear mote unit tween hear tween PC ing aid to hearing jing aid and and gt 30 cm be aid TM DEX NOAHIink tween hear ing aids or Hearing aid to TM DEX Center fre 10 6 MHz 10 6 MHz 10 6 MHz 2 4 GHz quency 40 Hearing aids RC DEX TM DEX Bluetooth NOAHlink Channel Single chan Single Single chan 5 logical nel radio channel nel radio channels radio Bandwidth 660 kHz C15 660kHz 660kHz 1MHz dB 15 qB 15 dB Data rate 212 kbit sec 212 kbit 212 kbit sec 2 1 Mbps ond raw second ond raw channel raw channel capacity channel capacity capacity Data flow Simplexor Simplex Simplexor Time division semi duplex capability semi duplex duplex capability capability TDD Protocol Random Ac Random Random Ac Packet cess no Access cess no based proto collision nocolli collision col time di avoidance sion avoidance vided secure avoidance Serial Port
9. any reason as you may risk swallowing it Risk of explosion if battery is replaced by an incorrect type or recharged Dispose of used batteries according to the instruc tions Never allow others to wear your hearing aid as this could cause permanent damage to their hearing 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 signals The hearing aid is made of modern non allergenic materials Nonetheless in rare cases skin irritation may occur If you notice skin irritation in or around your ear or ear canal contact your hearing care professional 33 AN Please note that when using any type of hearing aid you must allow regular ventilation of the ear the ear is not adequately ventilated there may be a slightly increased risk of infection or disease in the ear canal We therefore recommend that you remove the hearing aid and ear set from your ear when you go to bed to allow the ear canal to be ventilated If possible you should also remove your hearing aid and ear set during the day if there are any periods when you do not need them Make sure that you clean and inspect your hearing aid and ear set as required If an ear infection or disease occurs you should seek medical attention and contact your hearing care professional for advice on how to disinfect the various hearing aid p
10. perceive a decrease in loudness tolerance of sounds speech not as clear or worsening tinnitus contact your hearing care professional 20 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 background in quiet It may be used as a sound therapy tool in a tinnitus treatment program that is prescribed by a hearing care professional audiologists hearing aid specialists oto laryngologists who is trained in tinnitus management Directions for use Because of the unique ways in which Zen is programmed in your hearing aid please follow the recommendations 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 21 Precautions To ensure the safety and effectiveness of the Zen pro gram when used as a sound therapy tool for tinnitus the tinnitus management program must be designed and conducted by Hearing Healthcare Professionals who are trained in tinnitus management A tinnitus management program should include a complete audiological evaluation tinnitus diagnosis counseling use of proper amplification and or sound therapy tools Prior to any t
11. period of time Lost partner alarm Note Only applicable if this feature is available and has been activated 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 a diode LED will flash on both hearing aids When the lost hearing aid is repositioned and or the battery is exchanged the diodes stop flashing Programs Your hearing aid may be provided with several of the following programs plus the special Zen program called Zen In some DREAM hearing aids the Phone program can be made available instead of Zen Master Standard Music For listening to music TV For listening to the TV Comfort Attenuates background noise Reverse focus Focus on sounds from behind 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 tel ecoil 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 18 M T In this program you listen via the hearing aid microphones M and the telecoil T Zen Generates different kinds of tones or noise Compound The Master program in one ear and Zen Reverse programs focus T MT or Phone in the other Zen Special Zen program with up
12. 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 DREAM hearing aids distinguish between true hearing aid whistling or feed back and music sounds to prevent unnecessary feedback cancel lation and preserve natural sound quality 42 Contraindications Congenital or traumatic deformity of the ear Active drainage from the ear within 90 days History of rapid progressive hearing loss within previous 90 days Acute or chronic dizziness Sudden unilateral hearing loss in previous 90 days 43 RADIO TRANSMITTER CABLES TRANSDUCERS The DREAM series hearing aid contains a radio transmitter re ceiver with the following Radio transmitter parameters Frequency range 10 6 MHz 10 2 11 0 MHz Bandwidth 15dB 660 kHz Channel Single channel radio Modulation FSK Radiated output power 29 pW 75 dBm Magnetic field strength 54 dBuA m 10 m Duty Cycle gt 5 averaged over 1 hour of operation Simplex or semi duplex capability The radio receiver in the DREAM series hearing aid is 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 DREAM series hearing aid nor during programming of the hearing aid
13. 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 is transmitted are turned off only in some DREAM hearing aids Your hearing aid has a function called the Audibility Extender This feature makes high frequency sounds audible and can be set to operate for one or more or all available programs your needs change over time the combination of listening 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 optional listening program called Zen It makes musical tones and sometimes a rushing noise in the background 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 amplification so both the surrounding sounds and the generated sounds fractal tones and noise are heard together 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
14. T 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 purchas ing 8 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 med ically 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 you should inquire about the availability of a trial rental or purchase option program Many hearing aid dispensers now of fer programs that permit you to wear a hearing aid for a period of time for a nominal fee after wh
15. The hearing aid Clean the hearing aid with the soft cloth after use PARTE 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 keep it in a warm dry place with the battery drawer open to ventilate the hearing aid and allow it to dry 28 ACCESSORIES A variety of assistive listening devices are available for your hearing aid RC DEX remote control TV DEX for listening to TV and audio M DEX for cell phone applications and remote control PHONE DEX for easy landline use T DEX for connecting hearing aids to cell phones using a telecoil FM DEX the FM DEX is a high quality streaming device designed specifically for Widex hearing aids Available in some countries only 29 IN CASE OF MALFUNCTION Problem Possible 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 Your ear is blocked Contact your ENT doc aid volume is not powerful by earwax tor physician Your hearing may Contact your hearing enough have changed care professional The hearing Your ear is blocked Contact your ENT doc aid whistles by earwax tor physician continuously Your two The connection Turn the hearing aids off
16. WIDEX DREAM USER INSTRUCTIONS THE DREAM SERIES D FA model Behind the ear YOUR WIDEX HEARING AID To be filled out by the hearing care professional DREAM440 DREAM330 DREAM220 DREAM110 Programs Master Audi bility Extender Music Aud ibility Extender TV Aud ibility Extender Comfort Aud ibility Extender Reverse focus Aud ibility Extender Phone Audibility Extender T Audibility Extender M T Audibility Extender Zen Audibility Extender Master Zen Audi bility Extender Master Reverse focus Aud ibility Extender Master T Aud ibility Extender Master M T Aud ibility Extender Master Phone Aud ibility Extender Zen Audibility Extender Phone Audibility Extender Date Your hearing care professional CONTENTS THE HEARING AID 5 Acoustic indicators 8 The battery c s c rfc Ra eA e 9 Inserting the battery 9 Low battery indication 11 Turning the hearing aid on and off 12 Right left identification
17. arts Do not under any circumstances use alcohol chlorine or similar substances for this purpose Regular use of a de humidifier is recommended to help avoid malfunction of the hearing aid Do not use Widex hearing aids in mines or other areas with explosive gases 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 radiation such as that in a microwave oven can damage your hearing aid Radiation from for example room surveillance equipment burglar alarms and cell phones is weaker and will not damage the hearing aid but may create audible interference 34 VN ume Interference with active Implants In order to show caution we advise to follow the guidelines rec ommended by manufacturers of defibrillators and pacemakers regarding use of cell phones If you wear an active implantable device keep the Wireless Hearing Aids and Hearing Aid Accessories such as wireless remote controls or communicators at least 15 cm 6 inches away from the implant If you experience any interference do not use the hearing aids and contact the manufacturer of the implant Please note that interference can also be caused by power lines electrostatic discharge airport metal detectors etc If you have an active brain implant please contact the manu facturer of the implant for risk evaluation If you have an im
18. cation equipment and the DREAM series hear ing aids The DREAM 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 DREAM series hearing aid can help prevent electromagnetic interference by maintaining a mini mum distance between portable and mobile RF communications equipment transmitters and the DREAM hearing aids as recom mended below according to the maximum output power of the communications equipment 52 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 1 2 VP d 12VP d 2 3vVP 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 These guidelines may not apply in all situations Electro magnetic propagation is affected by absorption and reflection from structures objects and people This DREAM hearing aid may be interfered with by other
19. e bat tery if the hearing aid will not be used for several days When the hearing aid is not in use keep it in its case in a 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 surface Do not wear your hearing aid while in the shower or swimming or when using a hair dryer perfume hair and body sprays or gels such as suntanning lotions or creams 32 WARNINGS ANSE 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 Keep hearing aids and their parts accessories and batteries out of reach of children and anyone else who might swallow 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 your battery supply Discard used batteries carefully 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
20. e is exceeded or when communication is interfered 45 Wireless Security Measures Security of the wireless signals is assured through device system design that includes Individual MAC address for each unit which is checked during each transmission A built in pairing table which specifies valid and legitimate pairing among units A proprietary Widex communication protocol which checks the package numbers during each transmission A Cyclic Redundancy Check CRC to check data validity and correct errors 46 GUIDANCE AND MANUFACTURER S DECLARATION Electromagnetic emissions The DREAM series hearing aids are intended for use in the elec tromagnetic environment specified below The customer or the user of a DREAM series hearing aid should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 2 The DREAM 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 DREAM hearing aid is CISPR 11 suitable for use in all establish ments including domestic 65 ot 5 tablishments 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
21. e 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 communica tions 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 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 authority to operate the equipment 56 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 transmi
22. emoved 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 9 Use the nail grip to gently swing the battery drawer open act 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 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 Low battery indication An acoustic indicator will sound when the battery is nearly exhausted unless this function has been disa bled see page 8 We recommend that you always have 8 spare battery with you A WARNING Never leave an exhausted battery in the hearing aid Exhausted batteries may leak damaging the hearing aid WARNING 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 the hearing aid An acoustic indicator will indicate that the hearing aid has been switched on unless
23. equip ment even if that other equipment complies with CISPR emission requirements 53 EMI EMC Compliance The DREAM 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 300 330 2 RF emissions EMC and radio spectrum mat V1 5 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 perfor protocol mance 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 2011 RF Near Field hearing aids to ensure adequate immunity test immunity to radio interference from cell telephones ANSI C63 19 Immunity American National Standard 2007 RF Near Field Methods of measurement of immunity test Compatibility between wireless Communication Devices and Hearing Aids The device was tested in 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 54 IMPORTAN
24. es Your hearing aid may be provided with a listening program called Zen It makes musical tones and some times a rushing noise in the background These sounds are shaped according to your hearing loss A This hearing aid is capable of producing a sound pressure level exceeding 132 dB SPL There may be a risk of damaging your residual hearing Acoustic indicators The hearing aid may be set to produce a signal to indicate the use of certain functions The signal may be a spoken message or tones The signal can also be deactivated Functions Default Other settings settings Adjusting volume Tone Off Confirming program button use Clicking 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 Off Message Service reminder Off Message Note Warning about lost partner can only be made available in DREAM440 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 Inserting the battery 1 Before inserting a new battery into the hearing aid remember to remove the adhe gt sive tab Once the tab has been r
25. hearing aids between the hearing 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 hearing aids respond with a correspond ing change in volume or program to the DEX mission range b Strong electro magnetic interfer ence in the vicinity 6 The DEX and the hearing aids are not matched b Move away from known source of EM interference c Check with hearing care professional to make sure DEX is matched with hearing aids 30 Problem Possible cause Solution You hear interrupted speech on and off from the hearing aids or no speech muted from the transmit ting ear a The battery in one of the hearing aids has expired b Strong electro magnetic interfer ence in the vicinity a Replace battery in one or both hearing aids b Move away from known sources of interference Note This information covers only the hearing aid See the Ear sets for Widex BTE hearing aids user manual for information specific to your ear set If the problems persist contact your hearing care pro fessional for assistance 3i 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 Turn off your hearing aid when it is not in use Remove th
26. ich 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 physi cian Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or per sonal beliefs that preclude consultation with a physician The exer cise of such a waiver is not in your best health interest and its use is strongly discouraged 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 as sist in the evaluation and rehabilitation of a child with a hearing loss 55 FCC ID TTY DFA IC 5676B DFA 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 reasonabl
27. id volume is adjusted automatically in accordance with your sound environment Furthermore your hearing aid is provided with a volume control Push the upper part of the volume control to gradually raise the vol ume Push the lower part to gradually lower the volume Depending on hearing aid features and setting any change you make will affect both hearing aids To alter the increments in which the volume is increased or decreased consult your hearing care professional Each time you operate the volume control you will hear a beep tone unless this function has been disabled When the maximum or minimum adjustment level is reached a steady tone will sound 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 professional To turn off the sound completely Keep pressing the lower part of the volume control until the steady tone has sounded To turn the sound on again Press the upper part of the volume control or Change listening program Any adjustment of the volume setting will be canceled when your hearing aid is turned off or when you change program NOTE Your hearing aid can be set to gradually increase the amplification provided to allow you to acclimatize yourself to the sound through the hearing aid There fore you may notice an increase in level after a
28. innitus 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 healthcare 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 22 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 hearing aids stop using the hearing aids and the Zen program and seek attention from your hearing health care professional if any of the following symptoms are noted Skin irritation Perceived decrease in loudness tolerance of sounds speech not as clear or worsening tinnitus 23 Switching between the listening programs To change programs press the pro gram button briefly Each time you switch to another program an acoustic indicator will sound unless this function has been disabled Program 1 Message or one short beep Program 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 Zen or Phone Message or tone Depending on hearing aid featu
29. ionnement 57 C 0459 Hereby Widex A S declares that this D FA is in compli ance with the essential requirements and other relevant provisions of Directive 1999 5 EC A copy of the Declaration of Conformity can be found at http www widex com doc N26346 58 Electrical and electronic equipment EEE contains materials components and sub stances that can be hazardous and present a risk to human health and the environment when waste electrical and electronic equip ment WEEE is not handled correctly Do not dispose of hearing aids hearing aid accessories and batteries with ordinary household waste Hearing aids batteries and hearing aid accessories should be disposed of at sites intended for waste elec trical and electronic equipment or given to your hear ing care professional for safe disposal Proper disposal helps to protect human health and the environment 59 ADDITIONAL PROGRAM FORM Programs available in your hearing aid Program 1 Program 2 Program 3 Program 4 Program 5 Special program 60 SYMBOLS Symbols commonly used by Widex A S in medical device labelling labels IFU etc Symbol Title Description Manufacturer The product is produced by the manufacturer whose name and address are stated next to the symbol If ap propriate the date of manufacture may also be stated Date of manufacture The date when the product was ma
30. nufactured Use by date The date after which the product is not to be used Batch code The product s batch code lot or batch identification Catalogue number The product s catalogue item number Serial number The product s serial number Keep away from sunlight The product must be protected from light sources and or The product must be kept away from heat 61 Title Description Keep dry The product must be protected from moisture and or The product must be kept away from rain Lower limit of temperature The lowest temperature to which the product can be safely exposed Upper limit of temperature The highest temperature to which the product can be safely exposed Temperature limits The highest and lowest temperatures to which the prod uct can be safely exposed Consult instructions for use The user instructions contain important cautionary infor mation warnings precautions and must be read before using the product Caution Warning Text marked with a caution warning symbol must be read before using the product IX Snn WEEE mark Not for general waste When the product is to be discarded it must be sent to a designated collection point for recycling and recovery 62 Symbol Title Description CE CE mark The product is in conformity with the requirements set out in European CE marking directives
31. oday s newspaper Ask a friend or relative to read a story aloud while you read along with the same story Alternatively read it aloud and listen to your own voice It is also helpful to watch captioned TV 38 We hear in our brain not in our ears It will take your brain some time to fully adapt to the new sounds you are hearing It is not unusual for example to hear certain sounds such as your own footsteps or a newspaper rustling or the refrigerator humming that people with normal hearing take for granted and thus don t consciously process Be patient and allow yourself a few weeks to adapt Your brain will learn to ignore them if they are not important Of course if sounds are too loud or uncomfortable for you contact your hearing care professional Conversational speech has many redundant cues Worrying about a word you may have missed will likely lead to additional missed words Focus on the essence of the conversation It may help to ask someone you are comfortable with to subtly alert you about the overall topic when listening in groups Before going to a restaurant call ahead and request a seat away from the kitchen or bar area Remember that in noisy places even normal hearing people may struggle to hear 39 REGULATORY INFORMATION The following Table summarizes the technical details of the WidexLink technology as it is implemented in the DREAM hear ing aids Hearing aids
32. on 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 physician to clean your ears a couple of times a year 37 Adapting to your hearing aids Congratulations for taking the first steps toward re storing your communication skills with the purchase of state of the art hearing aids from Widex Because many of the sounds you may now hear have not been fully audible without hearing aids we urge you to take a few minutes to perform the following sim ple activities in the order listed Do these first in quiet settings then try them in noisier surroundings Activity 1 First listen to a friend or relative speak to you with your eyes closed and your hearing aids off Now put your hearing aids on and continue to listen Notice the difference The purpose of this activity is not to hear every word but just to recognize the difference in amplified speech from a familiar source Activity 2 Listen to your friend or relative speak to you with your hearing aids on but with your eyes closed Now continue to listen with your eyes open The goal is to demonstrate how helpful it is to receive information from your eyes to supplement your ears Activity 3 Purchase two copies of t
33. ould 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 Ujis the a c mains voltage prior to the application of the test level Battery powered equipment 49 Electromagnetic immunity cont The DREAM series hearing aids are intended for use in the elec tromagnetic environment specified below The customer or the user of a DREAM 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 DREAM 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 MHz to d 2 3 NP 61000 4 3 2 5 GHz 800 MHz to 2 5 GHz 50 Immunity Test IEC 60601 Test level Compli ance level Electromagnetic 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
34. plantable device we advise to keep magnets at least 15 cm 6 inches away from the implant can be speci fied as Autophone magnet hearing instrument case magnet in a tool etc 35 A CAUTION 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 compatibility standards the possibility cannot be excluded that it may cause interference with other equipment such as medical devices Never try to open or repair the hearing aid yourself To be performed by authorized personnel only 36 ADVICE NOTE The hearing aid will not restore normal hearing and will not prevent or improve a hearing loss resulting from organic condi tions However the hearing aid can help you to make the best possible use of your remaining hearing ability You should also bear in mind that it can take time to get used to a new hearing aid and new sounds In most cases using the hearing aid infrequently will not permit 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 instruc ti
35. res and setting any change you make will affect both hearing aids 24 Zen This program is accessed via a long press more than 1 second on the program button on the hearing aid or the RC DEX A short press then allows you to cycle through the available Zen styles You can exit Zen by pressing and holding the program button for more than 1 second Phone If your hearing aid is programmed with Phone instead of Zen this program is accessed via a long press more than 1 second on the program button on the hearing aid Please note that the program cannot be accessed via the RC DEX You can exit Phone by pressing and holding the same program button for more than 1 second If you wish to have the program button disabled please consult your hearing care professional 25 Using a telephone When using a telephone we recom mend that you hold the telephone against your head at an angle above your ear rather than directly against the ear If the sound is not optimal try moving the telephone earpiece to a slightly different posi tion 26 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 Cleaning thread Contact your hearing care professional if you need additional supplies of cleaning accessories Selection depends on ear set type 27
36. this function has been disabled To turn off the hearing aid open the bat tery drawer slightly to the first position where a Click is felt Note Another way to verify that the hearing aid is turned on is to cup it in your hand If it is on it will whis tle 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 Right left identification If you wear hearing aids on both ears the hearing aids can be provided with 8 colored marks red mark right and gt blue mark left The arrow shows the position of the identification mark Positioning the hearing aid Insert the earpiece in the ear canal while holding the lower part of the tube It may help to pull the outer ear backwards and upwards with the opposite hand Place the hearing aid behind the ear so that the hearing aid and tube rest comfortably on the ear close to your head The illustrations show an open ear tip For further infor mation on ear tip earmold 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 tube 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 a
37. tter by Industry Canada To reduce potential radio interference to other users the antenna type and its gain should be so chosen that the equivalent isotrop ically radiated power e i r p is not more than that necessary for successful communication 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 interfer ence that may cause undesired operation of the device Conform ment 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 quiva lente 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 licence 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 compro mettre le fonct

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