Widex UNIQUE Series User Instructions
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Widex UNIQUE Series User Instructions

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WIDEX UNIQUE
USER INSTRUCTIONS
THE WIDEX UNIQUE™ FAMILY
U-FS model
Receiver-in-the-ear

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Summary of Contents for Widex UNIQUE Series

  • Page 1 WIDEX UNIQUE USER INSTRUCTIONS THE WIDEX UNIQUE™ FAMILY U-FS model Receiver-in-the-ear...
  • Page 2 YOUR WIDEX® HEARING AID (To be filled out by the hearing care professional) Your hearing aid series: PROGRAMS  Universal  Audibility Extender  Quiet  Audibility Extender  Transport  Audibility Extender  Urban  Audibility Extender  Party ...
  • Page 3 That way you will always know which programs you have in your hearing aids. NOTE Read this booklet and the booklet "Ear-sets for Widex hearing aids" carefully before your start using your hearing aid.

  • Page 4: Table Of Contents

    CONTENTS YOUR WIDEX HEARING AID............... 6 Welcome to Widex..................6 Your hearing aid at a glance...............6 Important safety information.................7 THE HEARING AID..................9 Indications for use................... 9 Intended use.....................9 The battery....................... 9 Low battery indication................10 Changing the battery................. 10 Tamper-resistant battery drawer..............11 Sound signals....................11...
  • Page 5 Using a phone with hearing aids..............21 CLEANING....................22 Tools........................ 22 Cleaning the hearing aid................22 ACCESSORIES..................24 TROUBLESHOOTING................25 REGULATORY INFORMATION..............27 EC directives....................45 Directive 2014/53/EU................45 Information regarding disposal..............45 FCC and IC statements..................46 SYMBOLS....................49...

  • Page 6: Your Widex Hearing Aid

    YOUR WIDEX HEARING AID Welcome to Widex Congratulations on your new hearing aid. Use your hearing aid regularly, even if it takes some time getting used to it. Infrequent users don’t usually get the full benefit of a hearing aid.

  • Page 7: Important Safety Information

    Important safety information Read these pages carefully before you begin using your hearing aid. Hearing aids and batteries can be dangerous if swallowed or used im- properly. Swallowing or improper use can result in severe injury or even fatalities. In case of ingestion, contact a doctor immediately and call the 24 Hour National Button Battery Ingestion Hotline at (202) 625-3333.
  • Page 8 Your hearing aids are designed to operate within the temperature, humidity and atmospheric pressure ranges of 0°C (32°F) to 50°C (122°F), 10%-95% rH and 750 to 1060 mBar. You can find technical data sheets and additional information on your hear- ing aids on https://global.widex.com.

  • Page 9: The Hearing Aid

    THE HEARING AID Indications for use The hearing aids are indicated for individuals with a range of hearing loss from minimal (10 dB HL) to severe-to-profound (100 dB HL) and all hearing loss configurations. They are to be programmed by licensed hearing care professionals (audiol- ogists, hearing aid specialists, otolaryngologists) who are trained in hearing (re)habilitation.

  • Page 10: Low Battery Indication

    NOTE Check that the battery is completely clean and free of any residue before insert- ing it in the hearing aid. Otherwise your hearing aid may not function as expec- ted. Never attempt to recharge a zinc-air hearing aid battery, as it could ex- plode.

  • Page 11: Tamper-Resistant Battery Drawer

    Now place the new battery in the drawer as shown. Close the drawer. If it doesn't close easily, the bat- tery is not placed correctly. If you are not using the hearing aid for a few days, remove the battery. NOTE Avoid dropping your hearing aid - hold the hearing aid above a soft surface while changing the battery.

  • Page 12: Lost Partner

    Program 2 Message/two short beeps Program 3 Message/three short beeps Program 4 Message/one short and one long beep Program 5 Message/one long beep and two short beeps Zen+ Message/tone Ask your hearing care professional to turn these sounds signals off if you don't need them.

  • Page 13: Turning The Hearing Aid On And Off

    Turning the hearing aid on and off To turn the hearing aid on, close the battery door. The hearing aid will play a sound signal to indicate that it is on, unless your hearing care professional has deactiva- ted this function. To turn off the hearing aid, pull the battery door downwards.

  • Page 14: Programs

    Removing the hearing aid Start by removing the hearing aid from behind the ear. Then take the ear-set carefully out of the ear canal while you hold the lower part of the tube/earwire. Programs PROGRAMS Universal For everyday use Quiet Special program for listening in quiet environ- ments Transport...
  • Page 15 PROGRAMS With this program you listen through the hearing aid's telecoil, which allows you to listen directly to the sound without background noise (requires a teleloop system) This program is a combination of the hearing aid's microphone and the telecoil. You listen to the sound source, but can also hear other sounds SPECIAL PROGRAMS Plays tones or noise for a relaxing sound back-...

  • Page 16: Changing Programs

    NOTE The names in the list of programs are the default names. Your hearing care pro- fessional can also select an alternative program name from a preselected list. Then it is even easier for you to select the right program in each listening situa- tion.

  • Page 17: The Zen Program

    Phone+ To access this program, press and hold the program button for more than one second. To leave it repeat the same procedure. The Zen program Your hearing aid may be provided with a unique optional listening program called Zen. It makes musical tones (and sometimes a rushing noise) in the background using the latest Fractal technology.
  • Page 18 Benefits The Zen program may provide a relaxing listening background for some people. When the Zen program is used in a tinnitus management program, its wearer may experience some relief from tinnitus. Indications for use The Zen program is intended to provide a relaxing sound background for adults (21 years and older) who desire to listen to such a background in qui- et.
  • Page 19 Because of the unique ways in which Zen is programmed in your hearing aid, please follow the recommendations of your hearing care professionals as to how to use the program, when to use the program and/ or how long to use the program.

  • Page 20: Sound And Program Adjustment

    Warnings Use of the Zen program may interfere with hearing everyday sounds includ- ing 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 21: Using A Phone With Hearing Aids

    Tap the button on your right hearing aid if you’d like more audibility and more volume. If you need to decrease the volume or you’d like more com- fort, tap the button on your left hearing aid. A long push on either of your hearing aids will mute and unmute the sound (this setting is optional).

  • Page 22: Cleaning

    Dry your hearing aid quickly if it gets wet, or if you perspire heavily. Some people use a special dehumidifier like Widex PerfectDry Lux to help keep their hearing aids dry and clean. Ask your hearing care professional if this is...
  • Page 23 NOTE It is recommended to remove the batteries from the hearing aids before placing the hearing aids in a dehumidifier. When not in use leave the battery compartment open to ventilate the hear- ing aid. For information on how to clean your ear-set, see the ear-set man- ual.

  • Page 24: Accessories

    ACCESSORIES You can use a variety of accessories with your hearing aid. To see whether you could benefit from using these accessories, ask your hearing care professional. Name RC-DEX remote control TV-DEX for listening to TV and audio PHONE-DEX 2 for easy landline use FM+DEX for streaming audio and FM signals...

  • Page 25: Troubleshooting

    TROUBLESHOOTING These pages contain advice on what to do if your hearing aid stops working or if it doesn't work as expected. If the problem persists, contact your hear- ing care professional. Problem Possible cause Solution The hearing aid is com- It is not turned on Make sure the battery pletely silent...
  • Page 26 NOTE This information covers only the hearing aid. See the "Ear-sets for Widex hear- ing aids" user manual for information specific to your ear-set. If the problems persist, contact your hearing care professional for assistance.

  • Page 27: Regulatory Information

    REGULATORY INFORMATION The following Table summarizes the technical details of the WidexLink tech- nology as it is implemented in the UNIQUE™ hearing aids. Hearing aids RC-DEX TM-DEX Bluetooth* - NOAHlink Antenna Inductive anten- Inductive an- Inductive an- Embedded type tenna tenna ceramic an- tenna...
  • Page 28 Hearing aids RC-DEX TM-DEX Bluetooth* - NOAHlink Range < 1 m remote < 1 m remote < 30 cm be- < 10 m be- unit to hearing unit to hearing tween hearing tween PC aid and TM- and NOAH- < 30 cm be- link tween hearing aids or Hearing...
  • Page 29 Hearing aids RC-DEX TM-DEX Bluetooth* - NOAHlink Protocol Random Access Random Ac- Random Ac- Packet- – no collision cess – no colli- cess – no colli- based proto- avoidance sion avoid- sion avoidance col, time ance divided; se- cure Serial Port Profile (SPP) * Bluetooth specification v2.0 + EDR published by the Bluetooth Special In-...
  • Page 30 Synchronization of listening programs between hearing aids – The same lis- tening program is used in both hearing aids when one is changed by the user. Surveillance of partner hearing aid – The hearing aid(s) will signal an alert (“partner check”) when a hearing aid battery has expired, or that one of the hearing aids has fallen off.
  • Page 31 Modulation: FSK Radiated output power: 29 pW / -75 dBm Magnetic field strength: -54 dBμA/m @ 10 m Duty Cycle: < 5 % (averaged over 1 hour of operation) Simplex or semi duplex capability The radio receiver in the UNIQUE™ series hearing aid is using the same fre- quency and bandwidth as the transmitter.
  • Page 32 A built-in pairing table which specifies valid and legitimate pairing among units A proprietary Widex communication protocol which checks the package numbers during each transmission. A Cyclic Redundancy Check (CRC) to check data validity and correct errors. Guidance and manufacturer’s declaration...
  • Page 33 Electromagnetic emissions The UNIQUE™ series hearing aids are intended for use in the electromagnet- ic environment specified below. The customer or the user of a UNIQUE™ ser- ies hearing aid should assure that it is used in such an environment. Emissions test Compli- Electromagnetic environment - guidance ance...
  • Page 34 The UNIQUE™ series hearing aids are intended for use in the electromagnet- ic environment specified below. The customer or the user of a UNIQUE™ ser- ies hearing aid should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic...
  • Page 35 Immunity Test IEC 60601 Compliance Electromagnetic Test level level environment – guidance Surge ± 1 kV line(s) to line(s) applicable *) applicable *) 61000-4-5 ± 2 kV line(s) to earth applicable *) Voltage dips, short <5 % UT interruptions and (>95 % dip applicable *) applicable *)
  • Page 36 Immunity Test IEC 60601 Compliance Electromagnetic Test level level environment – guidance Power frequency 3 A/m 3 A/m Power frequency (50/60 Hz) mag- magnetic fields netic field should be at levels characteristic of a 61000-4-8 typical location in a typical commercial or hospital environ- ment NOTE UT is the a.c.
  • Page 37 Portable and mobile RF communications equip- ment should be used no closer to any part of the UNIQUETM series hear- ing aid, including cables, than the recommended separation distance cal- culated from the equa- tion applicable to the fre- quency of the transmit- ter.
  • Page 38 Immunity Test IEC 60601 Compliance Electromagnetic environ- Test level 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 recommen- ded separation distance in meters (m).
  • Page 39 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, ob- jects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur ra- dio, AM and FM radio broadcast and TV broadcast cannot be predicted the- oretically with accuracy.
  • Page 40 bile RF communications equipment (transmitters) and the UNIQUE™ hear- ing aids as recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of trans- output power of mitter (m) transmitter (W) 150 kHz to 80 80 MHz to 800 800 MHz to 2.5...
  • Page 41 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 42 EMC emission Medical electrical equipment. 60601-1-2:2007 Immunity, RF General requirements for basic safety *adapted proto- and ESD and essential performance. Electromagnetic compatibility. EN 301 489-3 Immunity, RF Standard for Low Power Transmitters in V1.6.1 and ESD the frequency range 9 kHz – 40 GHz IEC 60118- Immunity International Product std.
  • Page 43 (i) Visible congenital or traumatic deformity of the ear. (ii) History of active drainage from the ear within the previous 90 days. (iii) History of sudden or rapidly progressive hearing loss within the previous 90 days. (iv) Acute or chronic dizziness. (v) Unilateral hearing loss of sudden or recent onset within the previous 90 days.
  • Page 44 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.

  • Page 45: Ec Directives

    EC directives Directive 2014/53/EU Hereby, Widex A/S declares that this U-FS is in compliance with the essen- tial requirements and other relevant provisions of Directive 2014/53/EU. The U-FS contains a radio transmitter operating at 10.6 MHz, 54dBmA/m @10 m.

  • Page 46: Fcc And Ic Statements

    FCC and IC statements FCC ID: TTY-UFS IC: 5676B-UFS Federal Communications Commission Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
  • Page 47 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. ISED Statement / Déclaration d’ISED This device contains licence-exempt transmitter(s)/receiver(s) that comply with Inno- vation, Science and Economic Development Canada’s licence-exempt RSS(s).
  • Page 48 ISED RADIATION EXPOSURE STATEMENT: This equipment complies with ISED RF radiation exposure limits set forth for an uncon- trolled environment. This transmitter must not be co-located or operating in conjunc- tion with any other antenna or transmitter. ISED EXPOSITION AUX RADIATIONS: Cet equipement est conforme avec ISED les limites d’exposition aux rayonnements defi nies pour un controle environnement.

  • Page 49: Symbols

    SYMBOLS Symbols commonly used by WIDEX A/S in medical device labelling (la- bels/IFU/etc.) Symbol Title/Description Manufacturer The product is produced by the manufacturer whose name and address are stated next to the symbol. If appropriate, the date of manufacture may also be stated.
  • Page 50 Symbol Title/Description CE mark The product is in conformity with the requirements set out in European CE marking directives. RCM mark The product complies with electrical safety, EMC and radio spectrum regula- tory requirements for products supplied to the Australian or New Zealand markets.
  • Page 52 WIDEX A/S Nymoellevej 6, DK-3540 Lynge, Denmark https://www.global.widex.com Manual no.: 9 514 0317 041 #07 9 514 0317 041 #07 CIB number: CIB350 Issue: 2019-03...

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