Widex UNIQUE series User Instructions

Widex UNIQUE series User Instructions

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WIDEX UNIQUE
USER INSTRUCTIONS
THE WIDEX UNIQUE™ FAMILY
U-CIC/U-CIC-M model
Completely-in-canal

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Questions and answers

Stephen Barnes
March 13, 2025

Call dex pairing to unique fusion 220

1 comments:
Mr. Anderson
May 14, 2025

To pair a Widex DEX device (such as RC-DEX or TM-DEX) with UNIQUE Fusion 220 hearing aids:

1. Turn on the UNIQUE Fusion 220 hearing aids.
2. Place the DEX device close to the hearing aids (within 20 cm or 8 inches).
3. Activate the pairing mode on the DEX device. This is usually done by pressing and holding a specific button (refer to the DEX device manual).
4. The hearing aids will detect the DEX device and complete pairing automatically.
5. Once paired, the DEX device can control functions like volume or programs wirelessly.

Note: The CIC-M model is not wireless and cannot be paired.

This answer is automatically generated

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Summary of Contents for Widex UNIQUE series

  • Page 1 WIDEX UNIQUE USER INSTRUCTIONS THE WIDEX UNIQUE™ FAMILY U-CIC/U-CIC-M model Completely-in-canal...
  • Page 2 YOUR WIDEX® HEARING AID (To be filled out by the hearing care professional) Vent: Short Full length None CIC-M Your hearing aid series:...
  • Page 3 PROGRAM Universal Audibility Extender Quiet Audibility Extender Transport Audibility Extender Urban Audibility Extender Party Audibility Extender Music Audibility Extender SPECIAL PROGRAMS Audibility Extender Phone Audibility Extender Zen+ Audibility Extender...
  • Page 4 NOTE The CIC-M is not a wireless hearing aid, which means that the hear- ing aids cannot communicate with each other or with any accesso- ry. Consequently, you cannot adjust the sound and you will only have one listening program.
  • Page 5: Table Of Contents

    CONTENTS YOUR WIDEX HEARING AID..............7 Welcome to Widex..................7 Important safety information.................9 THE HEARING AID................. 14 Indications for use..................14 Intended use....................14 The battery...................... 15 Sound signals....................21 How to tell right from left................22 Turning the hearing aid on and off..............23 Putting on and removing your hearing aid..........
  • Page 6 The wax guard....................42 ACCESSORIES..................49 TROUBLESHOOTING................51 REGULATORY INFORMATION............... 58 FCC and IC statements and EC directives..........108 SYMBOLS....................111...
  • Page 7: 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 8 Your hearing aid at a glance 1. Microphone opening 2. Battery lid (on/off function) 3. Nail grip 4. Sound outlet 5. Widex wax guard...
  • Page 9: Important Safety Information

    6. Extraction cord 7. Relief vent (short) 8. Relief vent (full length) Important safety information Read these pages carefully before you begin using your hearing aid.
  • Page 10 Hearing aids and batteries can be dangerous if swallowed or used improperly. Swallowing or improper use can result in se- vere injury or even fatalities. In case of ingestion, contact a doctor immediately. In case of ingestion, contact a doctor im- mediately.
  • Page 11 Do not wear your hearing aids when applying perfume, spray, gels, lotion or cream. Do not dry your hearing aid in a microwave oven - this will ruin Never use other people’s hearing aids and never allow others to use yours, as this could damage your hearing. Never use your hearing aids in environments where there may be explosive gases, such as in mines, etc.
  • Page 12 Your hearing aids contain radio communication technology. Al- ways observe the environment in which you are using them. If any restrictions apply, you must take precautions to comply with these. Do not expose your hearing aids to extreme temperatures or high humidity, and dry them quickly if they get wet, or if you perspire heavily.
  • Page 13 For more information about your hearing aids, visit: www.widex.com.
  • Page 14: The Hearing Aid

    THE HEARING AID Indications for use The hearing aids are indicated for individuals older than 36 months with a range of hearing loss from minimal (10 dB HL) to severe (90 dB HL) and all hearing loss configurations. They are to be programmed by licensed hearing care professio- nals (audiologists, hearing aid specialists, otolaryngologists) who are trained in hearing (re)habilitation and tinnitus management.
  • Page 15: The Battery

    a relaxing sound background (i.e. music/noise source) for adults older than 21 years who desire to listen to such a background in quiet. The battery Use a type 10 zinc-air battery for your hearing aid. Always use a fresh, new battery that is precisely the kind recom- mended by your hearing care professional.
  • Page 16 Never attempt to recharge your hearing aid batteries, as they could explode. Never leave a flat battery in the hearing aids while storing them. It could leak and ruin your hearing aid. Dispose of used batteries as indicated on the packaging and take note of the expiry date.
  • Page 17 Use the nail grip to gently swing the battery door open and re- move the old battery.
  • Page 18 Take the adhesive tab off the new battery and make sure there is no sticky substance left on it. Let it "breathe" for 60 sec- onds.
  • Page 19 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, remove the battery.
  • Page 20 NOTE Avoid dropping your hearing aid - hold the hearing aid above a soft surface while changing the battery.
  • Page 21: 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. Message/one short beep Program 1 Message/two short beeps Program 2 Message or three short beeps...
  • Page 22: How To Tell Right From Left

    Ask your hearing care professional to turn these sounds signals off if you don't need them. Lost partner (Only available in wireless 440-series) Your hearing care professional can turn on a feature in your hear- ing aid that warns you whenever it loses contact with the hearing aid in the opposite ear.
  • Page 23: Turning The Hearing Aid On And Off

    Turning the hearing aid on and off To turn the hearing aid on, close the battery cover and push it up- wards. The hearing aid will play a sound signal to indicate that it is on, unless your hearing care professional has deactivated this function.
  • Page 24 To turn off the hearing aid, push the battery cover downwards. NOTE You can also cup the hearing aid in your hand to verify that it is turned on. If it's on, it will whistle. Don't forget to turn off the hearing aid when it is not in use.
  • Page 25: Putting On And Removing Your Hearing Aid

    Putting on and removing your hearing aid To put on your hearing aid: Close the battery cover completely. Hold the hearing aid with your thumb and forefinger and insert it slowly into your ear until you feel resistance.
  • Page 26 Then use the tip of your forefinger to gently push the hearing aid into your ear until it feels comfortable.
  • Page 27 Pulling the outer ear upwards and backwards while you insert the hearing aid can be helpful. NOTE If the hearing aid doesn't feel comfortable, or if it doesn't fit proper- ly, causing irritation, redness or the like, contact your hearing care professional.
  • Page 28 Removing the hearing aid Use the extraction cord to take the hearing aid out of your ear. NOTE If you find it difficult to take out the hearing aid, move it carefully from side to side while pulling on the extraction cord.
  • Page 29: Sound Adjustment

    Sound adjustment Your hearing aid adjusts the sound automatically according to your sound environment. If you have a remote control, you can also adjust the sound man- ually 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.
  • Page 30 ● Keep pressing the lower part of the volume key on the remote control until you can hear the steady sound To turn the sound on again: ● Press the upper part of the volume key or ● Change program Any adjustment of the volume will be canceled when you turn off your hearing aid or if you change program.
  • Page 31: Programs

    Programs PROGRAM Universal For everyday use Quiet Special program for listening in quiet en- vironments 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 similar) Party For listening in situations with many people talking at the same time...
  • Page 32 PROGRAM Music For listening to music SPECIAL PRO- GRAMS Plays tones or noise for a relaxing sound background. For more information, see under "The Zen program" Phone This program is designed for listening to phone conversations Zen+ This program is similar to Zen but allows you to listen to different types of tones or noise...
  • Page 33 Depending on your hearing loss, your hearing care professional can activate the Audibility Extender feature. Ask your hearing care professional if you could benefit from this. If your needs and preferences change over time, your hearing care professional can easily change your program selection Changing programs To change programs, simply push the program key on your re- mote control.
  • Page 34 The Zen program Your hearing aid may be provided with a unique optional listen- ing program called Zen. Indication for use The Zen program is intended to provide a relaxing sound back- ground (i.e., music/noise source) for adults who desire to listen to such a background in quiet.
  • Page 35 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. CAUTION If you perceive a decrease in loudness, tolerance of sounds, speech not as clear, or worsening tinnitus, contact your hearing...
  • Page 36: Cleaning

    CLEANING Tools You will receive the following cleaning tools with your hearing aid. 1. Cloth 2. Brush 3. Long wax removing tool 4. Short wax removing tool 5. Battery magnet Cleaning the hearing aid Cleaning your hearing aid every day will make it more efficient and more comfortable to wear.
  • Page 37 The hearing aid Just wipe it with the a soft cloth (for example the cloth you re- ceived from your hearing care professional).
  • Page 38 The sound outlet Remove any visible earwax from around the sound outlet with the small brush or cloth. Never try to clean the wax guard. NOTE If you can't clean the sound outlet, contact your hearing care profes- sional. Never insert anything into the sound outlet as this can ruin your hearing aid.
  • Page 39 Open the battery lid and turn the hearing aid so the lid is facing downwards (see illustration). Guide the short wax removing tool (no. 4 ) through the micro- phone openings on the lid from the inside (see illustration). NOTE If you suspect that earwax or dirt has got into the microphone inside the hearing aid, contact your hearing care professional.
  • Page 40 Long vent: clean the vent every Short vent: clean the vent as far day by passing the long wax re- as the long end of the wax re- moving tool (no. 3) all the way moving tool (no. 3) can reach. through the vent.
  • Page 41 Leave the hearing aid open to ventilate it. NOTE It is important for the performance of your hearing aid that you keep the vent clean and free of earwax, dirt or the like. Clean it every day after use and consult your hearing care professional if the vent is blocked.
  • Page 42: The Wax Guard

    Dry your hearing aid quickly if it gets wet, or if you perspire heav- ily. Some people use a special dehumidifier like Widex Dry-Go to help keep their hearing aids dry and clean. Ask your hearing care professional if this is right for you.
  • Page 43 Changing the wax guard Open the wax guard case as il- lustrated. The wax guard consists of the following parts: 1. Removal hook 2. New wax guard...
  • Page 44 Insert the removal hook into the used wax guard. Keep the holder at a right angle.
  • Page 45 Pull the used wax guard straight out.
  • Page 46 Insert the new wax guard into the opening of the sound outlet and press it gently. Pull the holder straight out.
  • Page 47 Ask your hearing care professional about how often you should change the wax guard.
  • Page 48 The wax guard is for one-time use only and is not intended to be cleaned. If the wax guard fits loosely, discard it and use a new one. If the wax guard falls off inside your ear, contact your doctor or hearing care professional to have it removed.
  • Page 49: 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* for easy landline use FM+DEX for streaming audio and FM signals UNI-DEX...
  • Page 50 Name CALL-DEX for easy wireless connection to mobile phones COM-DEX for wireless connection to mobile phones and other devices via bluetooth *Available in some countries only.
  • Page 51: 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 hearing care professional. Problem Possible cause Solution The hearing aid is It is not turned on Make sure the completely silent battery is placed...
  • Page 52 Problem Possible cause Solution The battery does not Insert a new bat- work tery in the hear- ing aid The sound outlet is See the cleaning blocked section The microphone See the cleaning sec- opening is blocked tion The hearing aid vol- The sound outlet is See the cleaning ume is not powerful...
  • Page 53 Problem Possible cause Solution Your hearing may Contact your hearing have changed care professional/ doctor The hearing aid Your ear is blocked by Contact your whistles continu- earwax doctor ously It is not correctly Take it out and placed in your ear ca- reinsert it It fits loosely in Contact your hearing...
  • Page 54 Problem Possible cause Solution The hearing aid is It is not correctly Consult your uncomfortable to placed in your ear ca- hearing care wear nal. professional It does not fit your ear Contact your properly hearing care professional...
  • Page 55 Problem Possible cause Solution Your outer ear or It is important that ear canal is sore first-time users only wear the hearing aid for short periods of time at the beginning. Take 2-3 weeks to gradually get used to the hearing aid. If the soreness continues, contact your hearing care professional...
  • Page 56 Problem Possible cause Solution The hearing aids do not respond with a The device is used be- Move the device corresponding yond the transmission closer to the change in volume range hearing aids or program to the device Strong electromag- Move away from netic interference in known source of...
  • Page 57 Problem Possible cause Solution make sure de- vice is matched with the hearing aids You hear “interrup- ted” speech (on The battery in one of Replace battery and off) from the the hearing aids has in one or both hearing aids or no expired hearing aids speech (muted)
  • Page 58: Regulatory Information

    REGULATORY INFORMATION The following Table summarizes the technical details of the Wi- dexLink technology as it is implemented in the UNIQUE™ hearing aids.
  • Page 59 Hearing RC-DEX TM-DEX Blue- aids tooth* - NOAHlink Antenna Inductive Inductive Inductive Embed- type antenna antenna antenna ded ce- ramic an- tenna Antenna Ø1.8 mm, Ø8 mm, Ø6 mm, dimen- L - 4.85 L – 20 mm L - 8 mm sions...
  • Page 60 Hearing RC-DEX TM-DEX Blue- aids tooth* - NOAHlink Modula- FHSS/ tion GFSK, π/4 DPSK, 8 DPSK Magnetic Field dBμA/m dBμA/m dBμA/m Strength (at 10 m distance)
  • Page 61 Hearing RC-DEX TM-DEX Blue- aids tooth* - NOAHlink Output 29 pW 21 nW 1.2 nW +4dB re. power (EIRP**)
  • Page 62 Hearing RC-DEX TM-DEX Blue- aids tooth* - NOAHlink Range < 1 m re- < 1 m re- < 30 cm < 10 m be- mote unit mote unit between tween PC to hearing to hearing hearing aid and - and TM- NOAHlink <...
  • Page 63 Hearing RC-DEX TM-DEX Blue- aids tooth* - NOAHlink Center fre- 10.6 MHz 10.6 MHz 10.6 MHz 2.4 GHz quency Channel Single Single Single 5 logical channel ra- channel channel ra- channels radio Bandwidth 660 kHz 660kHz 660kHz 1 MHz (-15 dB) (-15 dB) (-15 dB)
  • Page 64 Hearing RC-DEX TM-DEX Blue- aids tooth* - NOAHlink Data-rate 212 kbit/ 212 kbit/ 212 kbit/ 2.1 Mbps second second second (raw chan- (raw chan- (raw chan- nel capaci- nel capaci- nel capaci- Data flow Simplex or Simplex Simplex or Time divi- semi-du- capability semi-du-...
  • Page 65 Hearing RC-DEX TM-DEX Blue- aids tooth* - NOAHlink Protocol Random Random Random Packet- Access – Access – Access – based no collision no collision no collision protocol, avoidance avoidance avoidance time divi- ded; se- cure Serial Port Pro- file (SPP) * Bluetooth specification v2.0 + EDR published by the Bluetooth Special Interest Group (SIG).
  • Page 66 Bluetooth Identifier: B01837 Reference number of QPN: NOAHlinkV1.2_412832_QPN_E1 (Benefits) The use of wireless transmission allows convenient and synchronized control of hearing aid functions. The UNIQUE wire- less hearing aids share input information between the two part- ner hearing aids. In so doing, the wearers would experience the following additional user benefits (only when wearing binaural UNIQUE hearing aids).
  • Page 67 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. In rare instances, a much stronger wireless source nearby may activate this alert. This serves as an early warning to the wearer of such service interrup- tion.
  • Page 68 More accurate identification of feedback – The UNIQUE hearing aids distinguish between “true” hearing aid whistling (or feed- back) and music sounds to prevent unnecessary feedback cancel- lation and preserve natural sound quality. (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...
  • Page 69 The UNIQUE™ series hearing aid contains a radio transmitter / re- ceiver 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 dBμA/m @ 10 m Duty Cycle: <...
  • Page 70 The radio receiver in the UNIQUE™ series hearing aid is using the same frequency and bandwidth as the transmitter. Cables and transducers: No cables and transducers are used neither during normal use of the UNIQUE™ series hearing aid nor during programming of the hearing aid.
  • Page 71 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 required acknowledge, a transmission latency in each direction (2x) and a receive-to-transmit mode (RX to TX) time.
  • Page 72 Individual MAC address for each unit which is checked during each transmission. A built-in pairing table which specifies valid and legitimate pair- ing among units A proprietary Widex communication protocol which checks the package numbers during each transmission.
  • Page 73 A Cyclic Redundancy Check (CRC) to check data validity and cor- rect errors. Guidance and manufacturer’s declaration Electromagnetic emissions The UNIQUE™ series hearing aids are intended for use in the elec- tromagnetic environment specified below. The customer or the user of a UNIQUE™ series hearing aid should assure that it is used in such an environment.
  • Page 74 Emissions test Compli- Electromagnetic environment - ance guidance RF emissions Group 1 The UNIQUE™ hearing aid uses RF energy only for its internal function. CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
  • Page 75 Harmonic emissions applica- ble *) 61000-3-2 Voltage fluc- tuations/ applica- flicker emis- ble *) sions IEC 61000-3-3 *) Battery powered equipment Electromagnetic immunity...
  • Page 76 The UNIQUE™ series hearing aids are intended for use in the elec- tromagnetic environment specified below. The customer or the user of a UNIQUE™ series hearing aid should assure that it is used in such an environment.
  • Page 77 Immunity Test IEC 60601 Compli- Electromagnet- ance level ic environment Test level – guidance Immunity Test IEC 60601 Compli- Electromagnet- ance level ic environment Test level – guidance...
  • Page 78 Immunity Test IEC 60601 Compli- Electromagnet- ance level ic environment Test level – guidance Electrostatic dis- ± 6 kV con- ± 6 kV Floors should charge (ESD) tact contact be wood, con- crete or ceram- ± 8 kV air ± 8 kV air ic tile.
  • Page 79 Immunity Test IEC 60601 Compli- Electromagnet- ance level ic environment Test level – guidance Electrical fast ± 2 kV for transients/burst power line applicable applicable *) supplies ± 1 kV for in- 61000-4-4 put/output lines applicable...
  • Page 80 Immunity Test IEC 60601 Compli- Electromagnet- ance level ic environment Test level – guidance Surge ± 1 kV line(s) to line(s) applicable applicable *) 61000-4-5 ± 2 kV line(s) to earth applicable...
  • Page 81 Immunity Test IEC 60601 Compli- Electromagnet- ance level ic environment Test level – guidance Voltage dips, <5 % UT short interrup- (>95 % dip applicable applicable *) tions and volt- age variations in UT) for on power supply 0.5 cycle input lines 40 % UT (60 % dip...
  • Page 82 Immunity Test IEC 60601 Compli- Electromagnet- ance level ic environment Test level – guidance (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s...
  • Page 83 Immunity Test IEC 60601 Compli- Electromagnet- ance level ic environment Test level – guidance Power frequency 3 A/m 3 A/m Power frequen- (50/60 Hz) cy magnetic magnetic field fields should be at levels char- acteristic of a typical location 61000-4-8 in a typical commercial or hospital envi-...
  • Page 84 *) Battery powered equipment Electromagnetic immunity – cont. The UNIQUE™ series hearing aids are intended for use in the elec- tromagnetic environment specified below. The customer or the user of a UNIQUE™ series hearing aid should assure that it is used in such an environment.
  • Page 85 Immunity Test IEC 60601 Compli- Electromagnetic ance level environment – Test level guidance...
  • Page 86 Portable and mo- bile RF communi- cations equipment should be used no closer to any part of the UNIQUETM series hearing aid, including cables, than the recom- mended separa- tion distance cal- culated from the equation applica- ble to the frequen- cy of the transmit- ter.
  • Page 87 Recommended separation dis- tance Conducted RF 3 Vrms 3 Vrms d = 1.2 ÖP 150 kHz to 61000-4-6 80 MHz...
  • Page 88 Radiated RF 3 V/m 3 V/m d = 1.2 ÖP 80 MHz to 800 80 MHz to 61000-4-3 2.5 GHz d = 2.3 ÖP 800 MHz to 2.5 Immunity Test IEC 60601 Compli- Electromagnetic ance level environment – Test level guidance...
  • Page 89 Where P is the maximum output power rating of the transmitter in watts (W) accord- ing to the trans- mitter manufactur- er and d is the rec- ommended sepa- ration distance in meters (m). Field strengths from fixed RF transmitters, as determined by an...
  • Page 90 electromagnetic site survey a, should be less than the compliance level in each fre- quency range b. Interference may occur in the vicini- ty of equipment marked with the following symbol:...
  • Page 91 NOTE 1 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 reflec- tion from structures, objects and people.
  • Page 92 a. 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.
  • Page 93 Recommended separation distances between portable and mo- bile RF communication equipment and the UNIQUE™ series hear- ing aids. The UNIQUE™ series hearing aids are intended for use in the elec- tromagnetic environment in which RF disturbances are control- led. The customer or the user of the UNIQUE™ series hearing aid can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communica- tions equipment (transmitters) and the UNIQUE™...
  • Page 94 Rated maxi- Separation distance according to frequency of mum output transmitter (m) power of trans- 150 kHz to 80 80 MHz to 800 MHz to mitter (W) 800 MHz 2.5 GHz d = 1.2 ÖP d = 1.2 ÖP d = 2.3 ÖP 0.01 0.12 0.12...
  • Page 95 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 frequen- cy of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmit- ter manufacturer.
  • Page 96 This UNIQUE™ hearing aid may be interfered with by other equip- ment even if that other equipment complies with CISPR emission requirements. (EMI/EMC Compliance). The UNIQUE™ hearing aid complies with the following EMC/EMI standards:...
  • Page 97 Standard Test type Note 47 CFR Part 15, RF emis- USA Federal Communica- subpart C sions tions Commission (FCC) re- quirements for intentional radiators. EN 300 330-2 RF emis- EMC and radio spectrum sions incl. matters for Short Range De- V1.5.1 Spurious vices in the frequency range...
  • Page 98 IEC 60601-1-2:2007 EMC emis- Medical electrical equip- sion ment. *adapted protocol Immunity, General requirements for RF and basic safety and essential performance. Electromagnetic compatibil- ity. EN 301 489-3 V1.4.1 Immunity, Standard for Low Power RF and Transmitters in the frequen- cy range 9 kHz –...
  • Page 99 IEC 60118- Immunity International Product std. for hearing aids to ensure 13:2011 RF Near adequate immunity to radio Field im- interference from cell tele- munity test phones. ANSI C63.19-2007 Immunity American National Standard Methods of measurement of RF Near Compatibility between wire- Field im- less Communication Devices munity test...
  • Page 100 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 purchas- ing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists, or otorhinolaryngologists.
  • Page 101 The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid to your individual needs.
  • Page 102 sonal beliefs that preclude consultation with a physician. The ex- ercise of such a waiver is not in your best health interest and its use is strongly discouraged. 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...
  • Page 103 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 104 However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful in- terference to radio or television reception, which can be deter- mined by turning the equipment off and on, the user is encour- aged to try to correct the interference by one or more of the fol- lowing measures: —...
  • Page 105 Changes or modifications to the equipment not expressly ap- proved by Widex could void the user’s authority to operate the equipment. Industry Canada Statement / Déclaration d’industrie Canada...
  • Page 106 To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotrop- ically 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).
  • Page 107 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 équiva- lente (p.i.r.e.) ne dépasse pas l’intensité nécessaire à l’établisse- ment d’une communication satisfaisante.
  • Page 108: Fcc And Ic Statements And Ec Directives

    FCC and IC statements and EC directives Directive 1999/5/EC Hereby, Widex A/S declares that these U-CIC, U-CIC-TR, U-CIC-M and U-CIC-M-TR are in compliance with the essential require- ments 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://www.widex.com/doc...
  • Page 109 Information regarding disposal Electrical and electronic equipment (EEE) contains materials, components and substances that can be haz- ardous and present a risk to human health and the environment when waste electrical and electronic equipment (WEEE) is not handled correctly. Do not dispose of hearing aids, hearing aid accessories and bat- teries with ordinary household waste.
  • Page 110 (Continued) Hearing aids, batteries and hearing aid accessories should be disposed of at sites intended for waste electrical and electronic equipment, or given to your hearing care professional for safe disposal. Proper disposal helps to protect human health and the environment.
  • Page 111: Symbols

    SYMBOLS Symbols commonly used by Widex A/S in medical device label- ling (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 appropriate, the date of manufacture may also be stated.
  • Page 112 Symbol Title/Description Consult instructions for use The user instructions contain important cautionary information (warnings/precautions) and must be read before using the product. Warning Text marked with a warning symbol must be read before using the product.
  • Page 113 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 re- covering to prevent the risk of harm to the environ- ment or human health as a result of the presence of hazardous substances.
  • Page 114 Symbol Title/Description RCM mark The product complies with electrical safety, EMC and radio spectrum regulatory requirements for products supplied to the Australian or New Zealand market. Interference Electromagnetic interference may occur in the vicini- ty of the product.
  • Page 116 Nymoellevej 6, DK-3540 Lynge, Denmark WIDEX A/S www.widex.com Manual no.: 9 514 0315 041 #01 CIB346/0815 CIB number: 9 514 0315 041 #01 Issue: 2015-09...

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