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        User instrUctions cMe15-Bte • cMe10-Bte cMe5-Bte • cMe3
         Contents
1.                      11    Turning the hearing aid      and off  The battery drawer of the hearing aid also functions as  the on off switch     Push the switch upwards to turn on the   hearing aid  An acoustic indicator will           indicate that the hearing aid has been     switched on unless this function has been    1 disabled     Push the switch downwards to turn off the    hearing aid   Il  The word    OFF    is clearly visible on the  switch when the hearing aid is turned off             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     12    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 hear   ing aid and tube rest comfortably on the ear  close to  your head     bw     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     13    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     Z    14    Volume adjustment 
2.          60601  Test Test level                   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      Field 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        45           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 
3.         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                   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 in   stalled  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            If your needs change over time  the combination of lis   tening programs can be altered     17    Switching between the listening  programs   Each time you switch to another pro   gram  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     18    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 position     19                        The following cleaning accessories a
4.  30                WARNING            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 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  CT 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        31                WARNING    Interference with active Implants     In order to show caution  we advise to follow the guidelines  recommended by manvfacturers of defibrillators and pace   makers regarding use of cell phones       If you wear an active implantable device keep the
5.  The hearing aid volume is adjusted automatically in ac   cordance with your sound environment        Your hearing aid        furthermore  Y N be provided with a volume control    9 shaped like a small lever   Push the lever upward to gradually        raise the volume     Push the lever downwards to gradually lower the vol        ume     In the default setting  any volume adjustment will affect  both hearing aids     Each time you operate the volume control  you will  hear a beep tone unless this function has been disa   bled  When the maximum or minimum adjustment lev   el is reached  a steady tone will sound     15            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 turn off the sound completely    Keep pressing the volume control lever downwards  until the steady tone has sounded    To turn the sound on again    Press the lever upwards         Change listening program    Any adjustment of the volume setting will be canceled  when your hearing aid is turned off  or when you    change program     If you wish to have the volume control disabled  please  consult your hearing care professional     16       Listening programs   Your hearing aid may be provided with several of the  following programs  The number of programs avail   able depends on your specific hearing aid                              
6.  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 manvfacturer 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      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         32                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         33       ADVICE       NOTE            hearing aid will not restore normal hear
7.  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 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 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 modifi
8.  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 bat   tery drawer open      7            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     The hearing aid may be provided with a special battery  drawer  helping to secure the battery in the drawer  This  type of drawer can be a good choice if the hearing aid  is worn by a child     10    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 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  
9.  serious adverse reactions   potential safety hazards and inadequate performance of device        CAUTION    Messages with this heading indicate include information re   garding any special care to be exercised             Non ionizing radiation              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  Microphone openings   2  Volume control  optional    3  Program button   4  On off switch   5  Battery drawer with nail grip                 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          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 for use   The devices are indicated for individuals with a range of  hearing loss severity from mini
10. Gjcoseloi    Living life    coselqiG  melodia    USER INSTRUCTIONS          15                10               5          CMe3 BTE  Behind the ear    YOUR MELODIA    HEARING AID   To be filled out by the hearing care professional     Date        Battery size                 15        10        5                                         CONTENTS    SYMBOLS  odasi         RU ee eG ela aes 4  THE HEARING AID                            5  Right left identification                         8  Acoustic indicators                           8  Th   battery o Meta ns pae ate xe     9  Inserting the battery                         9  Low battery indication                       11  Turning the hearing aid on and off              12  Positioning the hearing aid                    13  Removing the hearing aid                     14  Volume adjustment                          15  Listening programs                          17  Switching between the listening programs        18  Using a telephone                           19  CLEANING    etr rc Eee ge e 20  The hearing aid                            21  ACCESSORIES           strate              ds 22  IN CASE OF MALFUNCTION                   26  CARING FOR YOUR HEARING AID               28  WARNINGS es ante jeep           alu eee EIER     29  ADVICE  Cu        A Med edem 34  REGULATORY INFORMATION                   35    SYMBOLS    The following symbols will be used throughout the  manual        WARNING    Messages with this heading indicate
11. 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 d en compro   mettre le fonctionnement     52           0459    Hereby  Coselgi A S declares that this CMe BTE 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    53    Hearing aids  accessories and botter   ies should not be disposed of with nor   mal household waste  Please consult your  national Coselgi distributor for advice on  how to dispose of these items     54    55                Ojcoselai    Living lif      Manufacturer  CE          ASIA          2540 na                                                    vor    COSELGI        MELODIA are trademarks of Coselgi A S                      
12. cations to the equipment not expressly approved  by Coselgi could void the user   s authority to operate the equip   ment     51    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 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 pas l intensit   n  cessaire    l   tablissement  d une communication satisfaisante     Le pr  sent appareil est conforme 
13. e 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 hearing  aids  see User instruc   tions for RC         27    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        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 ifs 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              28    WARNINGS          WARNING    Hearing aid
14. eld dBuA m   Strength    at 10 m   distance    Output 29       21       1 2 nW  4dB re    power ImW    EIRP      Range  lt 1m remote   lt  1m re   lt  50      be    lt  10 m be   unit to hear   mote unit  tween hear  tween PC  ing aid to hearing ling aid and           lt  30 cm be  aid TM DEX NOAHlink  tween hear   ing aids or  Hearing aid  to TM DEX   Center fre   10 6 MHz 10 6     2  10 6 MHz 2 4 GHz   quency                   35                      Hearing aids  RC remote  TM DEX Bluetooth     control NOAHlink   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   21 Mbps  ond  raw second ond  raw  channel  raw chan   channel  capacity  nel capaci   capacity    ty    Dataflow  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 no collision  collision col  time di   avoidance _javoidance                       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    36     Benefits  The use of wirele
15. er     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 equip   ment even if that other equipment complies with CISPR emission  requirements     47                   Compliance           Melodia    hearing aid complies with the following                                       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    RF 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  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 Immunity American National Standard  C63 19 2007   RF Near Field   Methods of measurement of       immunity tes
16. ic         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 equipment    41    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             6 kV contact   Floors should be  discharge tact  8kV 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 96   Electrical  2      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                   42             Immunity IEC 60601 Compliance Electromagnetic  Test Test level level environment    guidance   Voltage   5 96 U  Not Not  dips  short  295 96 dip applicable      applicable     interruptions   in 02 for  and v
17. ing 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             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       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 hear   ing aid considerably  It is a good idea to ask your physician to       clean your ears a couple of times a year           34    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 NOAHIink   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  20mm  L 8mm   sions   Modula    FSK FSK FSK FHSS GFSK    tion 1 4 DPSK  8   DPSK   Magnetic   54 dBuA m   13  26 dBuA m  NA   Fi
18. mal  10 dB HL  to severe   90 dB HL  and all hearing 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     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 Tone Off  Confirming program button use Clicking   Off  sound  Changing program Tones Off  Starting up the hearing aid Tone Off  Warning about low battery Atones                       The battery  We recommend zinc air batteries  Use a size 13 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    Before inserting a new battery into the hear     ing aid 
19. 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 equipment 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     46                         Rated maximum   Separation distance according to frequency  output power of of transmitter  m   transmitter 150kHzto   80MHzto   800 MHzto   w  80MHz   800 MHz 2 5 GHz  d 12VP   d 1 2VP 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   factur
20. nd 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     38    QUALITY OF SERVICE FOR WIRELESS TECHNOLOGY       THE WIDEXLINK SYSTEM    WidexLink wireless 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  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 ear communication be
21. ng 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 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     49    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     50    FCC ID           49  IC  5676B C49    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
22. oltage   0 5 cycle  variations on   40   U   power sup     60   dip  ply input in U  for 5  lines cycles  IEC 70   U   61000 4 1    30   dip   in      for 25   cycles     5 96 U      gt 95   dip        U  for 55  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 Ujis the a c  mains voltage prior to the application of the    test level           Battery powered equipment    43    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        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 3 VP   61000 4 3   2 5 GHz 800 MHz to 2 5 GHz                44       Immunity
23. ontain some quick advice on what  to do if your hearing aid stops working or performs un   satisfactorily  If the problems 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 pushed all the  pletely silent way upwards  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        earwax tor physician  not powerful      Md h Your hearing may Contact your hearing  g     have changed care professional       The hearing   Your ear is blocked   Contact your ENT doc   aid whistles by earwax tor physician  continuously       The hearing   The on off switch is   Push the switch back             aid functions   dirty and forth a couple of  intermittently times   Your two hear    The connection be    Turn the hearing aids  ing aids are tween the hearing off and on again   not working in   aids is lost   synchrony       26       Problem    Possible cause    Solution       The hearing  aids do not  respond with  a correspond   ing change in  volume or  program to  the RC    The RC is used be   yond the trans   mission range    Move the RC closer to  the hearing aids       Strong electro   magnetic interfer   ence in the vicinity    Mov
24. re 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     20              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           When the hearing aid is not in use  the  battery drawer should be left open  to   p    ventilate the hearing aid and allow it to  dry     21    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    22    Audio input   The hearing aid can be furnished with an audio shoe   This allows direct connection to different kinds of ac   cessories  FM and CROS Bi CROS systems   as well as  external audio equipment  radio  TV  etc    In this way  the sound from  for example  a radio or someone pro   vided with a FM microphone can be sent directly into  the hearing aid     In the standard setting  the hearing aid automatically  switches to an audio program when an audio shoe is  a
25. s 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 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              29               WARNING      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 sig   nals        The hearing aid is made of modern non allergenic moterials   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       
26. ss 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 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      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    37    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   lt  5    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 a
27. t       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     48    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 heari
28. ttached  If you then wish to switch to one of the other  programs  you must use the program button on the  hearing aid  As soon as you remove the audio shoe   the usual program order is re established     On the form below  your hearing care professional can  make a note of the audio programs you have access to    and where they are located     For more information on the use of audio input consult  your hearing care professional     23                      Program order with audio shoe       1                            A WARNING    If the hearing aid is connected to equipment which is connect   ed to the electrical mains  this equipment must comply with  IEC 60065  IEC 60950 1  IEC 60601 1 or equivalent UL safety  standards  Do not connect the hearing aid to sockets that are  labelled with one or more of the following symbols     v         24            systems  A FM system is      assistive listening device that        be  used as an accessory for the hearing aid     We recommend using the FM system from Widex called  SCOLA  The FM system consists of a wireless micro   phone and a receiver clicked onto the hearing aid via  a FM shoe     The SCOLA FM system can be set according to your  needs  This may mean that the hearing aid program  button will work differently than when using an audio  shoe     For help in determining whether you could benefit from  a FM system  please consult your hearing care profes   sional     25         CASE OF MALFUNCTION    The following pages c
29. tween 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     39    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 communication protocol which checks the  package numbers during each transmission      A Cyclic Redundancy Check  CRC  to check data validity and  correct errors     40    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 domest
    
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