Mini BTE - Coselgi
Contents
1. 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 you 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 af2. 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 40 Electromagnetic immunity cont The Melodia series hearing aids are intended for use in the elec tromagnetic environment specified below The customer or the user of a Melodia 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 Melodia 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 3VP 61000 4 3 2 5 GHz 800 MHz to 2 5 GHz 41 Immunity 60601 Test 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 Fi
3. 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 the 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 af ter heavy perspiration such as that which may occur during in tense 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 e 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 26 WARNINGS 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 con tact a physician immediately and the 24 Hour National But ton Battery Ingestion Hotline at 202 625
4. 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 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 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 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 sig nals 27 AS WARNING 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 yo
5. also be caused by power lines electrostatic discharge airport metal detectors etc f you have an active brain implant please contact the manu facturer of the implant for risk evaluation If you have an implantable device we advise to keep mag nets at least 15 cm 6 inches away from the implant can be specified as Autophone magnet hearing instrument case magnet in a tool etc 29 A CAUTION Your hearing aid has been tested for interference according to international standards Nevertheless it is possible that un foreseen interference may occur in the hearing aid due to elec tromagnetic radiation from other products such as alarm sys tems 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 Only to be performed by authorized personnel 30 ADVICE NOTE hearing aid will not restore normal hearing and will not prevent or improve a hearing loss resulting from organic con ditions 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 n
6. d en compro mettre le fonctionnement 49 CE 0459 Hereby Coselgi A S declares that this CMe M is in compliance with the essential requirements and other relevant provisions of Directive 1999 5 EC copy of the Declaration of Conformity can be found at http www coselgi com products doc N26346 50 Hearing aids accessories batter ies should not be disposed of with normal household waste Please consult your na tional Coselgi distributor for advice on how to dispose of these items 51 Ojcoselai Living lif Manufacturer CE ASIA 2540 na rm 252350 o COSELGI and MELODIA are trademarks of Coselgi A S
7. O coselgi Living life coselqiG melodia USER INSTRUCTIONS CMe15 M 10 CMe5 M CMe3 M MINI Behind the ear YOUR MELODIA HEARING AID To be filled out by the hearing care professional Date Battery size 15 10 5 CONTENTS SYMBOLS RU ee eG ela aes 4 THE HEARING AID 5 Right left identification 8 Acoustic indicators 8 Th battery coo s eaten pae e 9 Inserting the battery 9 Removing the battery 11 Battery drawer without a nail grip 12 Low battery 13 Turning the hearing aid on and off 14 Positioning the hearing aid 15 Removing the hearing aid 16 Volume adjustment 17 Listening programs 18 Switching between the listening programs 19 Using a telephone 20 CLEANING setae ee 21 hearing aid 22 The microphone openings 22 ACCESSORIES opii gad 23 IN CASE OF MALFUNCTION 24 CARING FOR YOUR HEARING AID 26 WARNINGS 27 ADVICE iss cst GaSb PR ERNE p E Res 31 REGULATOR
8. Y INFORMATION 32 3 SYMBOLS The following symbols will be used throughout the manual A WARNING 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 re garding any special care to be exercised Co Non ionizing radiation Mmm Not for general waste THE HEARING AID The illustration below shows the hearing aid without an ear set The choice of ear set solution depends on your specific needs Please refer to the separate ear set user manual 1 Microphone openings 2 On off function 3 Nail grip 4 LED RL ID 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 Coselgi BTE hearing aids A WARNING This booklet and the manual Ear sets for Coselgi BTE hear ing 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 ex actly as illustrated in this booklet We also reserve the right to make any changes considered necessary Intended use The Melodia hearing aids are intended as air conduc tion amplification devices to be used in everyday listen ing environments Indications
9. ace the hearing aid behind the ear so that the hear ing aid and tube rest comfortably on the ear close to your head The illustrations show an open dome For further infor mation on ear tip dome earmold types anchors and procedures see the separate ear set user manual pro vided 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 earpiece out of the ear canal Volume adjustment The hearing aid volume is adjusted automatically in accordance with your sound environment If you have a remote control you can also adjust the volume manually or mute your hearing aid Any ad justment of the volume setting will be canceled 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 If you have a remote control please also refer to the user instructions for this 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 Not available for CMe3 To mute the hearing aid with a remote control Keep pressing the volume down key on the remote
10. attery pack regarding disposal of used batteries Inserting the battery Before inserting new battery into the hear ing aid remember to remove the adhesive tab Once the tab has been removed wait 60 seconds before placing the battery into the hearing aid 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 battery drawer open Do not press the drawer beyond the open po sition Place the battery in the drawer as illustrated so that the plus sign on the battery is facing towards you when you hold the hearing aid as shown You can use the battery magnet provided to steer the battery into place e 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 Removing the battery 1 Open the battery drawer as previously described Place the hearing aid on the provided cloth on a clean plane surface and turn it as illustrated 2 Supporting the drawer with your finger use the bat tery magnet provided to push the battery out of the battery drawer from the minus side Battery drawer without a nail grip 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 typ
11. con trol until the long beep tone has sounded Pressing one of the volume keys briefly will bring back the sound Listening programs By default your hearing aid has one listening program However if you have a remote control a number of additional programs can be made available how many depends on your specific hearing aid Please also refer to the user instructions for your re mote control Main Standard Music For listening to music TV For listening to the TV Relax Attenuates background noise Rearview Focus on sounds from behind Phone For listening to the telephone If your needs change over time the combination of lis tening programs can be altered Not available for CMe3 Switching between the listening programs Each time you change program via a remote control an acoustic indicator will sound unless this function has been disabled Program 1 One short beep Program 2 Two short beeps Program 3 Three short beeps Program 4 One long and one short beep Program 5 One long and two short beeps In the default setting both your hearing aids will be af fected when you change programs Using a telephone When using a telephone we rec ommend that you hold the tel ephone 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
12. e 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 included with this drawer The battery drawer is opened as il lustrated 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 always have a spare battery with you WARNING Never leave an exhausted battery in the hearing aid Exhaust ed 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 and off The battery drawer of the hearing aid also functions as the on off switch Close the battery drawer to turn on the 5 hearing aid An acoustic indicator will indicate that the hearing aid has been switched on unless this function has been disabled Open the battery drawer to turn off the hearing aid Please remember to turn off the hear ing 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 tube It may help to pull the outer ear backwards and upwards with the opposite hand Pl
13. eld strengths from fixed RF transmitters as deter mined by an electromag netic site survey 2 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE1 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 42 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 mea sured field strength in the location in which the Melodia series hearing aid is used exceeds the applicable RF compliance level above the Melodia 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 Melodia 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 mobile RF communication e
14. ess technology enables communication between two partners of a binaural pair of Melodia hearing aids and with their matched external devices The requirements for the quality of service 005 vary among the various components and their intended user scenarios For programming these requirements include a BER Bit Error Rate better than 105 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 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 36 Wireless Security Measures Securit
15. for use The devices are indicated for individuals with a range of hearing loss severity from minimal 10 dB HL to mod erately severe 85 dB HL and all hearing loss config urations They are to be programmed by licensed hearing care professionals audiologists hearing aid specialists oto laryngologists who are trained in hearing re habilita tion Description of device Your hearing aid is used with an ear set which consists of a tube and an ear tip dome or earmold The hear ing aid uses a proprietary wireless technology to ena ble communication between the left and the right hear ing aids as well as between the hearing aids and its accessories Right left identification The arrow shows the position of the identification mark red mark right and blue mark left Acoustic indicators The hearing aid may be set to produce tones to indicate the use of certain functions Function Default Alternative setting setting Adjusting volume via remote control Tone Off Changing program via remote control Tones Off Starting up the hearing aid Tone Off Warning about low battery Atones Off Remote control not available for CMe3 The battery We recommend zinc air batteries Use a size 10 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 b
16. most cases using the hearing aid infrequently will not per mit you to gain full benefit from it use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading 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 hear ing aid considerably It is a good idea to ask your physician to clean your ears a couple of times a year 51 REGULATORY INFORMATION The following Table summarizes the technical details of the WidexLink technology as it is implemented in the Melodia hear ing aids Hearing aids RC remote TM DEX Bluetooth control NOAHlink Antenna Inductive an Inductive Inductive an Embedded type tenna antenna tenna ceramic an tenna Antenna 01 8 mm 08 mm 06 mm NA dimen L 4 85 mm L 20 mm 1 8 sions Modula FSK FSK FSK FHSS GFSK tion 4 DPSK 8 DPSK Magnetic 54 dBpA m 13 26 dBuA m Field dBuA m Strength at 10 m distance Output 29 pW 21 1 2 nW 4dBre power ImW EIRP Range lt 1m remote lt 1m re lt 30 cm be lt 10 be unit to hear mote unit tween hear tween PC ing aid to hearing jing aidand land lt 30cm be aid TM DEX NOAHIink t
17. ng 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 same listening program is used in both hearing aids when one is changed by the user 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 34 RADIO TRANSMITTER CABLES TRANSDUCERS The Melodia series hearing aid contains a radio transmitter receiver 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 5 6 averaged over 1 hour of operation Simplex or semi duplex capability The radio receiver in the Melodia series hearing aid is using the same frequency and bandwidth as the transmitter Cables and transducers No cables and transducers are used neither during normal use of the Melodia series hearing aid nor during programming of the hearing aid 35 QUALITY OF SERVICE FOR WIRELESS TECHNOLOGY THE WIDEXLINK SYSTEM WidexLink wirel
18. nt 38 Electromagnetic immunity The Melodia series hearing aids are intended for use in the elec tromagnetic environment specified below The customer or the user of a Melodia 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 KV 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 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 39 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 for and voltage 0 5 cycle variations on 40 U power sup 60 dip ply input in Uj for 5 lines cycles IEC 70 96 U 61000 4 1 30 dip in for 25 cycles 5 96 U gt 95 96 dip U for 5s Power fre 3 A m 3 A m Power frequency quency magnetic fields 50 60 Hz should be at lev
19. oblems persist contact your hear ing care professional for assistance See the Ear sets for Coselgi BTE hearing aids user manual for information specific to your ear set Problem Possible cause Solution The hearing The hearing aid is Make sure the battery aid is com not turned on drawer is closed pletely silent The battery does not work Insert a new battery in the battery drawer The hearing aid volume is not powerful Your ear is blocked by earwax Contact your ENT doctor physician Your hearing may enough Contact your hearing have changed care professional The hearing Your ear is blocked Contact your ENT aid whistles by earwax doctor physician continuously Your two hear ing aids are not working in synchrony The connection be tween the hearing aids is lost Turn the hearing aids off and on again 24 Problem Possible cause Solution The hearing RC is used Move the RC closer to aids do not beyond the trans the hearing aids respond with a correspond ing change in volume or program to the RC mission range Strong electro magnetic interfer ence in the vicinity Move away from known source of EM interference The RC battery is dead or does not work Change the RC battery The RC and the hearing aids are not matched Make sure RC is matched with hear ing aids see User in structions for RC 25
20. position 20 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 Coselgi BTE hear ing aids 1 Cloth 2 Wax removing tool 3 Cleaning thread Contact your hearing care professional if you need ad ditional supplies of cleaning accessories Selection depends on ear set type 21 gt The hearing aid Clean the hearing aid with the soft cloth after use WARNING Never use water or cleaning solutions to clean the hearing aid as this may cause it to malfunction The microphone openings Clean the microphone openings by passing the wax removing tool straight through the openings If you feel resistance withdraw the tool and try again Use only the wax removing tool provided 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 22 ACCESSORIES A number of assistive listening devices may be avail able for your hearing aid RC remote control TV Control For help in determining whether you could benefit from a remote control or other accessories please consult your hearing care professional Not available for CMe3 23 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 pr
21. quipment and the Melodia series hearing aids The Melodia series hearing aids are intended for use in the electromagnetic environment in which RF disturbances are con trolled The customer or the user of the Melodia series hearing aid can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communica tions equipment transmitters and the Melodia hearing aids as recommended below according to the maximum output power of the communications equipment 43 Rated maximum Separation distance according to frequency output power of of transmitter m transmitter 150kHzto 80MHzto 800 Mkz to W 80MHz 800MHz 2 5 GHz d 12VP dz12VP d 2 3 VP 0 01 0 12 0 12 0 23 01 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 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 Melodia hearing aid may be interfered with by other eq
22. roved 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 isotropi cally 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 interference 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 In dustrie 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 pos l intensit n cessaire l tablissement d une communication satisfaisante Le pr sent appareil est conforme aux CNR d Industrie Canada ap plicables 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
23. ter 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 46 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 47 FCC ID TTY C4M IC 5676B C4M 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 in terference 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 pro
24. uip ment even if that other equipment complies with CISPR emission requirements 44 EMI EMC Compliance The Melodia hearing aid complies with the following EMC EMI standards Standard Test type Note 47 CFR Part RF emissions USA Federal Communications 15 subpart C Commission FCC require ments for intentional radiators EN 300 330 emissions and radio spectrum mat 2V1 5 1 incl Spurious ters for Short Range Devices in emission the frequency range 9 kHz 25 MHz IEC 60601 1 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 mmunity International Product std for 13 2011 RF Near Field hearing aids to ensure adequate immunity test immunity to radio interference from cell telephones ANSI mmunity American National Standard C63 19 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 45
25. ur ear at night to allow the ear canal to be ven tilated 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 profession al for advice on how to disinfect the various hearing aid parts Do not under any circumstances use alcohol chlorine or sim ilar substances not use the hearing aids in mines or other areas with ex plosive gases not wear your hearing aid during radiation X rays MRIs or other medical treatments and scans The emis sions from these procedures as well as from other types of ra diation 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 interfer ence 28 WARNING Interference with active Implants n order to show caution we advise to follow the guidelines recommended by manufacturers of defibrillators and pace makers regarding use of cell phones you wear an active implantable device keep the Wireless Hearing Aids and Hearing Aid Accessories such as wireless re mote 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
26. vide 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 instal lation 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 ap proved by Coselgi could void the user s authority to operate the equipment 48 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 app
27. ween hear ing aids or Hearing aid to TM DEX Center fre 10 6 MHz 10 6 MHz 10 6 MHz 2 4 GHz quency 32 Hearing aids RC remote TM DEX Bluetooth control NOAHIink Channel Single chan Single Single chan 5 logical nel radio channel ra nel radio channels dio Bandwidth 660 kHz 15 660kHz 660kHz 1MHz dB 15 dB 15 dB Data rate 212 kbit sec 212 kbit 212 kbit sec 2 1 Mbps ond raw second ond raw channel raw chan channel capacity nel capaci capacity ty Dataflow Simplex or 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 no collision collision col time di avoidance lavoidance avoidance vided se 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 NOAHlinkV1 2 412832 QPN E1 35 Benefits use of wireless transmission allows convenient and synchronized control of hearing aid functions The Melodia wireless hearing aids share input information between the two partner hearing aids In so doing the wearers would experience the following additional user benefits only when wearing binaural Melodia heari
28. y 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 communication protocol which checks the package numbers during each transmission A Cyclic Redundancy Check CRC to check data validity and correct errors 37 GUIDANCE AND MANUFACTURER S DECLARATION Electromagnetic emissions The Melodia series hearing aids are intended for use in the elec tromagnetic environment specified below The customer or the user of a Melodia series hearing aid should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Melodia hearing aid uses CISPR 11 RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interfer ence in nearby electronic equipment RF emissions Class B The Melodia hearing aid is CISPR 11 suitable for use in all establish ments including domestic a Se tablishments 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 equipme
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