Related Manuals for Widex U-FA
Summary of Contents for Widex U-FA
- Page 1 WIDEX UNIQUE USER INSTRUCTIONS THE WIDEX UNIQUE™ FAMILY U-FA/U-FP model Behind-the-ear...
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Page 2: Table Of Contents
CONTENTS YOUR WIDEX HEARING AID..............4 Welcome to Widex..................4 Important safety information.................5 THE HEARING AID...................7 Indications for use....................7 Intended use.....................7 The battery....................... 7 Sound signals....................10 How to tell right from left................10 Turning the hearing aid on and off............... 11 Putting on and removing your hearing aid..........12 Sound adjustment.................. - Page 3 REGULATORY INFORMATION............... 23 EC directives....................41 FCC and IC statements..................42 SYMBOLS....................45...
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Page 4: 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 5: 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. In case of in- gestion, contact a doctor immediately and the 24 Hour National Button Battery Ingestion Hotline at (202) 625-3333. - Page 6 Storage and transportation up to 60°C (140°F) with 10%-95% rH can be ac- cepted in shorter periods (duration of max. of 2 weeks). Your hearing aids are designed to operate from 0°C (32°F) to 50°C (122°F). For more information about your hearing aids, visit: www.widex.com.
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Page 7: The Hearing Aid
THE HEARING AID Indications for use The FASHION model is indicated for individuals with a range of hearing loss from minimal (0 dB HL) to severe-to-profound (95 dB HL) and all hearing loss configurations. The FASION POWER model is indicated for individuals with a range of hear- ing loss from minimal (20 dB HL) to severe-to-profound (110 dB HL) and all hearing loss configurations. -
Page 8: Low Battery Indication
Always use a fresh, new battery that is precisely the kind recommended by your hearing care professional. 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. - Page 9 Use the nail grip to gently swing the battery door open and remove the old battery. Now place the new battery in the drawer as shown. Close the drawer. If it doesn't close easily, the battery is not placed correctly. If you are not using the hearing aid for a few days, re- move the battery.
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Page 10: Sound Signals
Sound signals Your hearing aid plays sounds to inform you that certain features have been activated or that you have changed programs. These sounds may be spoken messages or tones, depending on your needs and preferences. Program 1 Message/one short beep Program 2 Message/two short beeps Program 3... -
Page 11: Turning The Hearing Aid On And Off
Turning the hearing aid on and off To turn the hearing aid on, close the battery drawer. The hearing aid will play a sound signal to indicate that it is on, unless your hearing care professional has deac- tivated this function. To turn off the hearing aid, push the battery drawer downwards. -
Page 12: Putting On And Removing Your Hearing Aid
Putting on and removing your hearing aid To put on your hearing aid: 1. Insert the ear-set in the ear while holding the lower part of the tube. Pulling the outer ear up- wards and backwards at the same time can be helpful. -
Page 13: Sound Adjustment
Sound adjustment Your hearing aid adjusts the sound automatically according to your sound environment. You can also adjust the sound manually to achieve more comfort or more audibility, depending on your needs and preferences. For more information on how this works, consult your hearing care professional. Depending on the hearing aid settings and features, any sound adjustment you make will affect both hearing aids. - Page 14 PROGRAMS Quiet Special program for listening in quiet environ- ments Transport For listening in situations with noise from cars, trains, etc. Urban For listening in situations with changing sound levels (in supermarkets, noisy workplaces or sim- ilar) Party For listening in situations with many people talk- ing at the same time Music For listening to music...
- Page 15 SPECIAL PROGRAMS Plays tones or noise for a relaxing sound back- ground. For more information, see under "The Zen program" Phone This program is designed for listening to phone conversations SMARTTOGGLE PRO- GRAMS Zen+ This program is similar to Zen but allows you to listen to different types of tones or noise Phone+ This program is designed for listening to phone...
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Page 16: Changing Programs
If your needs and preferences change over time, your hearing care profes- sional can easily change your program selection. Changing programs To change programs, simply push the program button. NOTE The Phone+ program can't be accessed using a remote control. Zen+ To access this program, press and hold the program button for more than one second. -
Page 17: Using A Phone With Hearing Aids
Directions for use Because of the unique ways in which Zen is programmed in your hearing aid, please follow the recommendations of your hearing care professionals as to how to use the program, when to use the program and/or how long to use the program. -
Page 18: Cleaning
Dry your hearing aid quickly if it gets wet, or if you perspire heavily. Some people use a special dehumidifier like Widex Dry-Go UV to help keep their hearing aids dry and clean. Ask your hearing care professional if this is right... - Page 19 When not in your ears leave the battery compartment open to ventilate the hearing aid. For information on how to clean your ear-set, see the ear-set manual. Do not use any kind of liquid or disinfectant to clean your hearing aid. Clean and inspect your hearing aid every day after use to check that it is not broken.
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Page 20: Accessories
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 pro- fessional. Name RC-DEX remote control TV-DEX for listening to TV and audio PHONE-DEX for easy landline use FM+DEX for streaming audio and FM signals... -
Page 21: 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 22 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.
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Page 23: 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 24 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 25 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 26 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 27 Sudden unilateral hearing loss in previous 90 days Radio transmitter / cables / transducers The UNIQUE™ 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...
- Page 28 WidexLink wireless technology enables communication between two part- ners of a binaural pair of UNIQUE hearing aids and with their matched exter- nal 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 10-3, at a bitrate of 212 kbits/s, a semi-duplex transmission with a re- quired acknowledge, a transmission latency in each direction (2x) and a re-...
- Page 29 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 Electromagnetic emissions The UNIQUE™...
- Page 30 Harmonic emissions applica- IEC 61000-3-2 ble *) Voltage fluctu- ations/ flicker applica- emissions IEC ble *) 61000-3-3 *) Battery powered equipment Electromagnetic immunity 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.
- Page 31 Immunity Test IEC 60601 Compliance Electromagnetic Test level level environment – guidance Electrostatic dis- ± 6 kV contact ± 6 kV con- Floors should be charge (ESD) ± 8 kV air tact wood, concrete or ± 8 kV air ceramic tile. If floors 61000-4-2 are covered with synthetic material,...
- Page 32 Immunity Test IEC 60601 Compliance Electromagnetic Test level level environment – guidance Voltage dips, short <5 % UT interruptions and (>95 % dip applicable *) applicable *) voltage variations in UT) for on power supply 0.5 cycle input lines 40 % UT (60 % dip 61000-4-11 in UT) for 5 cycles...
- Page 33 *) Battery powered equipment Electromagnetic immunity – cont. 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...
- Page 34 Recommended separa- tion distance d = 1.2 ÖP Conducted RF 3 Vrms 3 Vrms 61000-4-6 150 kHz to 80 Radiated RF 3 V/m 3 V/m d = 1.2 ÖP 80 MHz to 800 MHz 61000-4-3 d = 2.3 ÖP 80 MHz to 2.5 800 MHz to 2.5 GHz Immunity Test IEC 60601...
- Page 35 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). Field strengths from fixed RF transmitters, as determined by an elec- tromagnetic site survey a, should be less than the compliance level in each...
- Page 36 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 37 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 38 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 39 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 V1.4.1 and ESD the frequency range 9 kHz – 40 GHz IEC 60118- Immunity International Product std.
- Page 40 yngologists, otologists, or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing 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.
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Page 41: Ec Directives
EC directives Hereby, Widex A/S declares that this U-FA is in compliance with the essen- tial requirements and other relevant provisions of Directive 1999/5/EC. A copy of the Declaration of Conformity according to 1999/5/EC can be found at: http://widex.com/doc... -
Page 42: Fcc And Ic Statements
FCC and IC statements FCC ID: TTY-UFA IC: 5676B-UFA FCC ID: TTY-UFP IC: 5676B-UFP 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 43 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. Industry Canada Statement / Déclaration d’industrie Canada...
- Page 44 (2) this device must accept any interference, including interference that may cause undesired operation of the device. 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...
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Page 45: 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 ad- dress are stated next to the symbol. If appropriate, the date of manu- facture may also be stated. - Page 46 Symbol Title/Description WEEE mark “Not for general waste” When a product is to be discarded, it must be sent to a designated collection point for recycling and recovering to prevent the risk of harm to the environment or human health as a result of the presence of hazardous substances.
- Page 48 WIDEX A/S Nymoellevej 6, DK-3540 Lynge, Denmark www.widex.com Manual no.: 9 514 0330 041 #01 9 514 0330 041 #01 CIB number: CIB348 Issue: 2016-07...