Widex DREAM D-9 User Instructions

Widex DREAM D-9 User Instructions

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USER INSTRUCTIONS
THE WIDEX DREAM™ FAMILY
D-9 model
Behind-the-ear

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  • Page 1 USER INSTRUCTIONS THE WIDEX DREAM™ FAMILY D-9 model Behind-the-ear...
  • Page 2 YOUR WIDEX HEARING AID (To be filled out by the hearing care professional) Your hearing aid series: ___________________________________________ Programs: … Master … Music … TV … Comfort … Reverse focus … Phone … T … M+T...
  • Page 3 … Zen … Master + Zen … Master + Reverse focus … Master + T … Master + M+T … Master + Phone … Zen+ … Phone+ Date Your hearing care professional...
  • Page 4: Table Of Contents

    CONTENTS THE HEARING AID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Acoustic indicators .
  • Page 5 CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 The hearing aid .
  • Page 6: The Hearing Aid

    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 .
  • Page 7 “Ear-sets for Widex BTE hearing aids” . WARNING 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 .
  • Page 8 Intended use The hearing aids are intended as air conduction amplification devices to be used in everyday listening environments . The hear- ing aids may be provided with the Zen program intended to pro- vide a relaxing sound background (i .e . music/noise source) for adults who desire to listen to such a background in quiet .
  • Page 9 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 propri- etary wireless technology, WidexLink, to enable communication between the left and the right hearing aids, as well as between the hearing aids and the DEX accessories .
  • Page 10: Acoustic Indicators

    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...
  • Page 11: The Battery

    The battery We recommend zinc-air batteries . Use a size 13 battery 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 .
  • Page 12 CAUTION Do not use batteries if there is a sticky residue from the tab or other un- wanted substance, as this can cause the hearing aid to malfunction . Use the nail grip to gently swing the battery drawer open .
  • Page 13 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 incor- rectly inserted .
  • Page 14 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 .
  • Page 15: Low Battery Indication

    Low battery indication An acoustic indicator will sound when the battery is nearly exhausted, unless this function has been disabled (see page 10) . We recommend that you always have a spare battery with you . WARNING Never leave an exhausted battery in the hearing aid . Exhausted batter- ies may leak, damaging the hearing aid .
  • Page 16: Turning The Hearing Aid On And Off

    Turning the hearing aid on and off The battery drawer of the hearing aid also functions as the on/ off switch . Push the switch upwards to turn on the hear- ing aid . An acoustic indicator will indicate that the hearing aid has been switched on unless this function has been disabled .
  • Page 17 The word “OFF” is clearly visible on the switch when the hearing aid is turned off . 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 whistle . Please remember to turn off the hearing aid when it is not in use .
  • Page 18: Right/Left Identification

    Right/left identification If you wear hearing aids on both ears, the hearing aids can be provided with col- ored marks (red mark = right and blue mark = left) . The arrow shows the position of the iden- tification mark .
  • Page 19: Positioning The Hearing Aid

    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 .
  • Page 20 The illustrations show an open ear-tip . For further information on ear-tip/earmold types, anchors and procedures, see the separate ear-set user manual provided . If the ear-set does not fit or sit properly, causing discomfort, irri- tation, redness or the like, contact your hearing care professional .
  • Page 21: Removing The Hearing Aid

    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 extrac- tion cord, take hold of this and carefully pull the ear-tip out of the ear canal .
  • Page 22: Volume Adjustment

    Volume adjustment The hearing aid volume is adjusted automatically in accordance with your sound environment . Your hearing aid may furthermore be provided with a volume control, shaped like a small lever . Push the lever upward to gradually raise the vol- ume .
  • Page 23 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 . WARNING 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 .
  • Page 24 To turn off the sound completely • Keep pressing the volume control lever downwards after the steady tone has sounded To turn the sound on again • Press the lever upwards 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 .
  • Page 25: Lost Partner Alarm

    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 message will sound two times in the other hearing aid .
  • Page 26: Programs

    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 For listening to the TV Comfort...
  • Page 27 In this program you listen via the hearing aid micro- phones (M) and the telecoil (T) . Generates different kinds of tones or noise . Compound The Master program in one ear and Zen, Reverse focus, programs T, MT or Phone in the other . Zen+ Special Zen program with up to three different Zen styles...
  • Page 28 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 .
  • Page 29 Precautions To ensure the safety and effectiveness of the Zen program when used as a sound therapy tool for tinnitus, the tinnitus manage- ment program must be designed and conducted by Hearing Healthcare Professionals who are trained in tinnitus manage- ment .
  • Page 30 Warnings Use of the Zen program may interfere with hearing everyday 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 . Risks There are no known risks or side effects associated with the use of the Zen program .
  • Page 31: Switching Between The Listening Programs

    Switching between the listening programs To change programs, press the program but- ton 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:...
  • Page 32: Zen

    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 .
  • Page 33: Using A Telephone

    Using a telephone When using a telephone, we rec- ommend that you hold the tele- phone against your head at an angle above your ear, rather than directly against the ear . If the sound is not optimal, try moving the tele- phone earpiece to a slightly differ- ent position .
  • Page 34: Cleaning

    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 .
  • Page 35: The Hearing Aid

    The hearing aid Clean the hearing aid with the soft cloth after use . If the microphone openings are still blocked, contact your hearing care professional . WARNING Never use water or cleaning solutions to clean the hearing aid, as this may cause it to malfunction .
  • Page 36: Accessories

    TV-DEX for listening to TV and audio M-DEX for cell phone applications and remote control 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...
  • Page 37 Direct audio input (DAI) 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 . ) . On the form on the next page, your hearing care professional can make a note of the audio programs you have access to and where they are located .
  • Page 38 Program order M-DAI … … … … … … … … … …...
  • Page 39 WARNING If the hearing aid is connected to equipment which is connected 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:...
  • Page 40 FM systems The Widex FM system, SCOLA, consists of a wireless microphone and a receiver clicked onto the hearing aid via an FM shoe . The system can be set according to your needs . For more information on the SCOLA FM system, consult the SCOLA™...
  • Page 41: In Case Of Malfunction

    IN CASE OF MALFUNCTION Problem Possible cause Solution The hearing aid is The hearing aid is not Make sure the battery completely silent turned on drawer is pushed all the way upwards The battery does not Insert a new battery in the work hearing aid The hearing aid...
  • Page 42 Problem Possible cause Solution The hearing aid The on/off switch is Push the switch back and func tions dirty forth a couple of times intermit tently Your two hearing The connection Turn the hearing aids off aids are not work- between the hearing and on again ing in synchrony...
  • Page 43 . 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 professional for...
  • Page 44: Caring For Your Hearing Aid

    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:...
  • Page 45 CAUTION • Turn off your hearing aid when it is not in use . Remove the battery 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 .
  • Page 46: Warnings

    WARNINGS WARNING Hearing aids and batteries can be dangerous if swal lowed 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 Battery Ingestion Hotline at (202) 625-3333 .
  • Page 47 • Clean and inspect your hearing aid after use to check that it is intact . If the hearing aid or the ear-set breaks while in the ear canal, contact your hearing care professional immediately . Do not try to remove the parts yourself .
  • Page 48 WARNING • The hearing aid is made of modern non-allergenic materials . None- theless, in rare cases skin irritation may occur . If you notice skin irri- tation in or around your ear or ear canal, contact your hearing care professional .
  • Page 49 • Regular use of a de-humidifier is recommended to help avoid mal- function of the hearing aid . • Do not use Widex hearing aids in mines or other areas with explo- sive gases . • Do not wear your hearing aid during radiation, X-rays, MRIs, CT or other medical treatments and scans .
  • Page 50 WARNING Interference with active Implants • In order to show caution, we advise to follow the guidelines recom- mended by manufacturers of defibrillators and pacemakers regard- ing 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 .
  • Page 51 CAUTION • Your hearing aid has been tested for interference according to inter- national standards . Nevertheless, it is possible that unforeseen inter- ference may occur in the hearing aid due to electromagnetic radia- tion from other products such as alarm systems, room surveillance equipment and cell phones .
  • Page 52: Advice

    ADVICE NOTE • The hearing aid will not restore normal hearing and will not prevent or improve a hearing loss resulting from organic conditions . How- ever, the hearing aid can help you to make the best possible use of your remaining hearing ability .
  • Page 53: Regulatory Information

    REGULATORY INFORMATION The following Table summarizes the technical details of the WidexLink technology as it is implemented in the DREAM™ hearing aids . Hearing aids RC-DEX TM-DEX Bluetooth* - NOAHlink Antenna Inductive Inductive Inductive Embedded type antenna antenna antenna ceramic antenna Antenna Ø1 .8 mm,...
  • Page 54 Hearing aids RC-DEX TM-DEX Bluetooth* - NOAHlink Output 29 pW 21 nW 1 .2 nW +4dB re . power (EIRP**) Range < 1 m remote < 1 m < 30 cm < 10 m unit to hearing remote unit between hear- between PC to hearing ing aid and TM-...
  • Page 55 Hearing aids RC-DEX TM-DEX Bluetooth* - NOAHlink Data-rate 212 kbit/sec- 212 kbit/ 212 kbit/second 2 . 1 Mbps ond (raw second (raw (raw channel channel channel capacity) capacity) capacity) Data flow Simplex or Simplex Simplex or Time divi- semi-duplex capability semi-duplex sion duplex capability...
  • Page 56 Bluetooth Identifier:  B01837 Reference number of QPN: NOAHlinkV1 .2_412832_QPN_E1 (Benefits) The use of wireless transmission allows convenient and syn- chronized control of hearing aid functions . The DREAM wireless hearing aids share input information between the two partner hearing aids . In so doing, the wearers would experience the following additional user bene- fits (only when wearing binaural DREAM hearing aids) .
  • Page 57 Coordination of compression – The DREAM hearing aids maintain the intensity level difference between ears (inter-aural level difference, ILD) . In some situations where speech is presented to one side and noise the other side, this coordinated action could enhance the relative loudness of the speech sounds to the noise background and improve speech under- standing for some wearers .
  • Page 58 RADIO TRANSMITTER / CABLES / TRANSDUCERS The DREAM™ 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 •...
  • Page 59 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 intended user scenarios .
  • Page 60 • 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...
  • Page 61 GUIDANCE AND MANUFACTURER’S DECLARATION Electromagnetic emissions The DREAM™ series hearing aids are intended for use in the electro- magnetic environment specified below . The customer or the user of a DREAM™ series hearing aid should assure that it is used in such an envi- ronment .
  • Page 62 RF emissions Class B The DREAM™ hearing aid is suitable CISPR 11 for use in all establishments, includ- ing domestic establishments and Harmonic emis- those directly connected to the pub- sions applicable *) lic low-voltage power supply net- IEC 61000-3-2 work that supplies buildings used Voltage fluctua- for domestic purposes .
  • Page 63 Electromagnetic immunity The DREAM™ series hearing aids are intended for use in the electro- magnetic environment specified below . The customer or the user of a DREAM™ series hearing aid should assure that it is used in such an envi- ronment .
  • Page 64 Immunity IEC 60601 Compliance Electromagnetic Test Test level level environment – guid- ance Electrical fast ± 2 kV for transients/ power line applicable *) applicable *) burst supplies ± 1 kV for 61000-4-4 input/output applicable *) lines Surge ± 1 kV line(s) to line(s) applicable *) applicable *)
  • Page 65 Immunity IEC 60601 Compliance Electromagnetic Test Test level level environment – guid- ance Voltage dips, <5 % U short inter- (>95 % dip applicable *) applicable *) ruptions and in U ) for voltage vari- 0 .5 cycle ations on 40 % U power supply (60 % dip...
  • Page 66 Immunity IEC 60601 Compliance Electromagnetic Test Test level level environment – guid- ance Power fre- 3 A/m 3 A/m Power frequency quency magnetic fields (50/60 Hz) should be at levels magnetic characteristic of a field typical location in a typical commercial or 61000-4-8 hospital environment NOTE U...
  • Page 67 Electromagnetic immunity – cont. The DREAM™ series hearing aids are intended for use in the electro- magnetic environment specified below . The customer or the user of a DREAM™ series hearing aid should assure that it is used in such an envi- ronment .
  • Page 68 Recommended separation distance Conducted 3 Vrms 3 Vrms √ d = 1 .2 150 kHz to 61000-4-6 80 MHz √ Radiated RF 3 V/m 3 V/m d = 1 .2 80 MHz to 800 MHz √ 61000-4-3 80 MHz to d = 2 .3 2 .5 GHz 800 MHz to 2 .5 GHz...
  • Page 69 Immunity IEC 60601 Compli- Electromagnetic environ- Test Test level ance level ment – guidance Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m) . Field strengths from fixed RF transmitters, as determined by an electromagnetic site...
  • Page 70 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies . NOTE 2 These guidelines may not apply in all situations . Electromag- netic propagation is affected by absorption and reflection from struc- tures, objects and people . a .
  • Page 71 Recommended separation distances Recommended separation distances between portable and mobile RF communication equipment and the DREAM™ series hearing aids . The DREAM™ series hearing aids are intended for use in the electromag- netic environment in which RF disturbances are controlled . The customer or the user of the DREAM™...
  • Page 72 Rated maximum Separation distance according to frequency of output power of transmitter (m) transmitter (W) 150 kHz to 80 80 MHz to 800 MHz to 2 .5 800 MHz √ √ √ d = 1 .2 d = 1 .2 d = 2 .3 0 .
  • Page 73 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 manufacturer .
  • Page 74 (EMI/EMC Compliance). The DREAM™ hearing aid complies with the following EMC/EMI stan- dards: Standard Test type Note 47 CFR Part 15, RF emissions USA Federal Communications subpart C Commission (FCC) requirements for intentional radiators . EN 300 330-2 RF emissions EMC and radio spectrum matters V1 .5 .
  • Page 75 IEC 60118- Immunity International Product std . for hear- 13:2011 RF Near Field ing aids to ensure adequate immu- immunity test nity to radio interference from cell telephones . ANSI C63 . 1 9- Immunity American National Standard Meth- 2007 RF Near Field ods of measurement of Compati- immunity test...
  • Page 76 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 .
  • Page 77 If you have reservations about your ability to adapt to amplification, 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 .
  • Page 78 FCC ID: TTY-DMCB IC: 5676B-DMCB 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 interfer- ence that may cause undesired operation .
  • Page 79 . 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 .
  • Page 80 Industry Canada Statement/Déclaration d’industrie Canada Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada . To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radi- ated power (e .i .r .p .
  • Page 81 Conformément à la réglementation d’Industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d’un type et d’un gain maximal (ou inférieur) approuvé pour l’émetteur par Industrie Can- ada . Dans le but de réduire les risques de brouillage radioélectrique à l’intention des autres utilisateurs, il faut choisir le type d’antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p .i .r .e .
  • Page 82 Directive 1999/5/EC Hereby, Widex A/S declares that this D-9 is in compliance with the essential requirements and other relevant provisions of Direc- tive 1999/5/EC . A copy of the Declaration of Conformity according to 1999/5/EC can be found at: http://www . w idex .com/doc...
  • Page 83 Electrical and electronic equipment (EEE) contains materials, components and substances that can be hazardous and present a risk to human health and the environment when waste electrical and elec- tronic equipment (WEEE) is not handled correctly . Do not dispose of hearing aids, hearing aid accessories and bat- teries with ordinary household waste .
  • Page 84: Symbols

    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 .
  • Page 85 Symbol Title/Description Catalog number The product’s catalog (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 Keep dry The product must be protected from moisture and/or The product must be kept away from rain Lower limit of temperature...
  • Page 86 Symbol Title/Description 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 .
  • Page 87 Symbol Title/Description 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 . CE mark The product is in conformity with the requirements set out in European CE marking directives .
  • Page 88 Symbol Title/Description Interference Electromagnetic interference may occur in the vicinity of the product . *The six- or seven-digit number on the product is the serial number . Serial numbers may not always be preceded by...
  • Page 92 WIDEX A/S Nymoellevej 6, DK-3540 Lynge, Denmark www . w idex .com Manual no .: É[5qr0w2|a;fa;l] 9 514 0221 041 #04 Issue: 2015-12 CIB291/1215...

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