background image

IEC

60601-1-2:2007

*adapted proto-

col

EMC emission

Immunity, RF

and ESD

Medical electrical equipment.

General requirements for basic safety

and essential performance.

Electromagnetic compatibility.

EN 301 489-3

V1.6.1

Immunity, RF

and ESD

Standard for Low Power Transmitters in

the frequency range 9 kHz – 40 GHz

IEC 60118-

13:2011

Immunity

RF Near Field

immunity test

International Product std. for hearing

aids to ensure adequate immunity to ra-

dio interference from cell telephones.

ANSI

C63.19-2007

Immunity

RF Near Field

immunity test

American National Standard Methods of

measurement of Compatibility between

wireless Communication Devices and

Hearing Aids

* The device was tested in only one orientation that represents the longest

length (or worst case scenario). This is acceptable because of the relative

small size of the device compared to the wavelength of the RF used in the

test.

Warning to hearing aid dispensers

A hearing aid dispenser should advise a prospective hearing aid user to con-

sult promptly with a licensed physician (preferably an ear specialist) before

dispensing a hearing aid if the hearing aid dispenser determines through in-

quiry, actual observation, or review of any other available information con-

cerning the prospective user, that the prospective user has any of the fol-

lowing conditions:

42

Summary of Contents for UNIQUE U-FS

Page 1: ...WIDEX UNIQUE USER INSTRUCTIONS THE WIDEX UNIQUE FAMILY U FS model Receiver in the ear ...

Page 2: ...eries PROGRAMS Universal Audibility Extender Quiet Audibility Extender Transport Audibility Extender Urban Audibility Extender Party Audibility Extender Music Audibility Extender T Audibility Extender M T Audibility Extender SPECIAL PROGRAMS Zen Audibility Extender Phone Audibility Extender 2 ...

Page 3: ...e the default names If you have chosen to use some of the other names available write the new names in the table 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 3 ...

Page 4: ...use 9 Intended use 9 The battery 9 Low battery indication 10 Changing the battery 10 Tamper resistant battery drawer 11 Sound signals 11 Lost partner 12 How to tell right from left 12 Turning the hearing aid on and off 13 Putting on and removing your hearing aid 13 Programs 14 Changing programs 16 The Zen program 17 Sound and program adjustment 20 4 ...

Page 5: ...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 5 ...

Page 6: ...We also reserve the right to make any changes we consider necessary Your hearing aid at a glance The illustration shows your hearing aid without the ear set For further in formation on the ear set see the ear set manual The ear set consists of an earwire and an ear tip and it is the part of your hearing aid that you wear inside your ear 3 1 2 4 1 On off switch 2 Battery drawer with nail grip 3 Pro...

Page 7: ...ct your doctor or hearing care professional immediately if you sus pect you may have an ear infection or an allergic reaction Contact your hearing care professional if the hearing aid doesn t feel comfortable or if it doesn t fit properly causing irritation redness or the like Remove your hearing aids before showering swimming or using a hair dryer Do not wear your hearing aids when applying perfu...

Page 8: ...l and it can play sounds that exceed a level of 132 dB There may therefore be a risk of damaging your remain ing hearing Do not expose your hearing aids to extreme temperatures or high humid ity and dry them quickly if they get wet or if you perspire heavily Your hearing aids should be stored and transported within the temperature and humidity ranges of 20 C to 55 C 4 F to 131 F and 10 95 rH Your ...

Page 9: ...e trained in hearing re habilitation Intended use The hearing aids are intended as air conduction amplification devices to be used in everyday listening environments The hearing aids may be equipped with the Zen program intended to provide a relaxing sound background i e music noise source for adults who desire to listen to such a back ground in the quiet The battery Use a type 312 zinc air batter...

Page 10: ...ispose of used batteries as indicated on the packaging and take note of the expiry date Low battery indication When the battery is weak a sound signal will play If the battery drains sud denly there may however be no warning We recommend carrying a spare battery with you wherever you go Changing the battery To change the battery do as follows Take the adhesive tab off the new battery and make sure...

Page 11: ...attery drawer If the hearing aid is going to be used by a child or a mentally disabled per son you can ask your hearing care professional to provide it with a tamper resistant battery drawer To open battery drawer use the special tool you ve received and do as illustrated Sound signals Your hearing aid plays sounds to inform you that certain features have been activated or that you have changed pr...

Page 12: ...rn these sounds signals off if you don t need them Lost partner Only available in selected models Your hearing care professional can turn on a feature in your hearing aid that warns you whenever it loses contact with the hearing aid in the opposite ear You will hear a spoken message in your ear How to tell right from left The hearing aid for your right ear has a red mark The hearing aid for your l...

Page 13: ...hearing aid when it is not in use Putting on and removing your hearing aid Putting on the hearing aid 1 2 1 Insert the ear set in the ear while holding the lower part of the tube earwire Pulling the outer ear upwards and backwards at the same time can be helpful 2 Then place the hearing aid behind the ear The hearing aid should rest comfortably on the ear close to your head Your hearing aid can be...

Page 14: ...rams PROGRAMS USE Universal For everyday use 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 14 ...

Page 15: ... but can also hear other sounds SPECIAL PROGRAMS USE Zen Plays tones or noise for a relaxing sound back ground Phone This program is designed for listening to phone conversations SMARTTOGGLE PRO GRAMS USE Zen This program is similar to Zen but allows you to listen to different types of tones or noise Phone This program lets you listen to the phone and avoid the surrounding sounds One of your hear ...

Page 16: ...e 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 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 progra...

Page 17: ...h a simple push of the program button The Zen program may be used alone without amplification in quiet when you are not required to hear surrounding sounds Or it may be used with amplification so that both the surrounding sounds and the generated sounds fractal tones and noise are heard together CAUTION Use of the different Zen programs may interfere with hearing surrounding sounds including speec...

Page 18: ...agement Directions for use The Zen program can be activated with a simple push of the program but ton on the hearing aid or on the remote control Depending on how your hearing care professional has set up the program you can access the Zen program by a short press of the program button or a long press of the program button Short press option the program button is pressed for less than a sec ond At...

Page 19: ...te audiological evaluation tinnitus diagnosis counseling use of proper amplification and or sound therapy tools Prior to any tinnitus management program it is advisable that you seek medical attention to exhaust any medical or surgical treatment options Use your hearing aid and the Zen program according to the directions and schedule recommended by your hearing care professionals Contraindications...

Page 20: ...your hearing care professional if any of the following symptoms are noted Skin irritation Perceived decrease in loudness tolerance of sounds speech not as clear or worsening tinnitus Sound and program adjustment If you have two hearing aids the push button can be programmed in several ways As a dedicated program button To change programs just tap the button To access and exit SmartToggle programs ...

Page 21: ... this option 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 if you d like more comfort just tap the button on your left hearing aid A long push on either of your hearing aids will change programs If you only have one hearing aid a short tap will change programs and a long tap will allow you to access the SmartToggle prog...

Page 22: ...nt and more comfortable to wear Wipe the hearing aid with a soft cloth for example the cloth you received from your hearing care profes sional If the microphone openings are blocked contact your hearing care professional 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 cle...

Page 23: ...ng aid For information on how to clean your ear set see the ear set man ual 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 If the hearing aid breaks while you are wearing it leaving small fragments in your ear canal contact your doctor Never try to take out the fragments yourself 23 ...

Page 24: ...or easy landline use FM DEX for streaming audio and FM signals T DEX for connecting hearing aids to mobile phones via a telecoil UNI DEX for connecting hearing aids to mobile phones CALL DEX for easy wireless connection to mobile phones COM DEX for wireless connection to mobile phones and other devices via Bluetooth COM DEX Re mote Mic for helping hearing aid users hear speech in dif ficult listen...

Page 25: ...e sure the battery drawer is completely closed The battery does not work Insert a new battery The hearing aid volume is not powerful enough Your ear is blocked by earwax Contact your doctor Your hearing may have changed Contact your hearing care professional doctor The hearing aid whistles continuously Your ear is blocked by earwax Contact your doctor Your two hearing aids are not working in syn c...

Page 26: ...ing care professional to make sure the device is matched with hearing aids You hear interrupted speech on and off from the hearing aids or no speech muted from the opposite hearing aid a The battery in one of the hearing aids has ex pired b Strong electromag netic interference in the vicinity a Replace battery in one or both hearing aids b Move away from known source of EM in terference NOTE This ...

Page 27: ... DEX TM DEX Bluetooth NOAHlink Antenna type Inductive anten na Inductive an tenna Inductive an tenna Embedded ceramic an tenna Antenna di mensions Ø1 8 mm L 4 85 mm Ø8 mm L 20 mm Ø6 mm L 8 mm NA Modulation FSK FSK FSK FHSS GFSK π 4 DPSK 8 DPSK Magnetic Field Strength at 10 m dis tance 54 dBμA m 13 dBμA m 26 dBμA m NA Output power EIRP 29 pW 21 nW 1 2 nW 4dB re 1mW 27 ...

Page 28: ...quency 10 6 MHz 10 6 MHz 10 6 MHz 2 4 GHz Channel Single channel radio Single channel radio Single channel radio 5 logical channels Bandwidth 660 kHz 15 dB 660kHz 15 dB 660kHz 15 dB 1 MHz Data rate 212 kbit second raw channel ca pacity 212 kbit sec ond raw channel ca pacity 212 kbit sec ond raw chan nel capacity 2 1 Mbps Data flow Simplex or semi duplex ca pability Simplex capa bility Simplex or s...

Page 29: ...d power 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 wireless hearing aids share input information between the two partner hearing aids In so do ing the wearers would experience the following additional user benefits only when wearing binaural U...

Page 30: ...ifference between ears inter au ral 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 im prove speech understanding for some wearers More accurate identification of feedback The UNIQUE hearing aids distin guish between true hearing aid wh...

Page 31: ...vice for Wireless Technology in the WidexLink System 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 tha...

Page 32: ...n between hearing aids a BER better than 10 3 is required The communication is updated every 50 ms or 20 Hz The hearing aids continue to amplify based on the last saved settings even when the transmission range is exceeded or when communication is interfered Wireless Security Measures Security of the wireless signals is assured through device system design that includes Individual MAC address for ...

Page 33: ...ly for its internal function Therefore its RF emis sions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The UNIQUE hearing aid is suitable for use in all establishments including domestic establish ments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purpos...

Page 34: ...ironment guidance Immunity Test IEC 60601 Test level Compliance level Electromagnetic environment guidance Electrostatic dis charge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV con tact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidi ty should be at least 30 Electrical fast tran sients burst IEC 61000 4 4 2 kV for power line...

Page 35: ...ine s 2 kV line s to earth Not applicable Not applicable Not applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s Not applicable Not applicable 35 ...

Page 36: ...ial or hospital environ ment NOTE UT is the a c mains voltage prior to the application of the test level 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 T...

Page 37: ...es than the recommended separation distance cal culated from the equa tion applicable to the fre quency of the transmit ter Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms Recommended separa tion distance d 1 2 ÖP Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m d 1 2 ÖP 80 MHz to 800 MHz d 2 3 ÖP 800 MHz to 2 5 GHz 37 ...

Page 38: ...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 frequency range b Interference may occur in the vicinity of equipment marked with the follow ing symbol 38 ...

Page 39: ...the UNIQUE series hearing aid is used exceeds the applicable RF compliance level above the UNIQUE series hearing aid should be observed to verify normal operation If abnormal performance is observed additional measures may be necessa ry such as re orienting or re locating the UNIQUE series hearing aid b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommende...

Page 40: ...mum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of trans mitter m 150 kHz to 80 MHz d 1 2 ÖP 80 MHz to 800 MHz d 1 2 ÖP 800 MHz to 2 5 GHz d 2 3 ÖP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 40 ...

Page 41: ...tions Electromagnetic propagation is affected by absorption and reflection from structures ob jects and people This UNIQUE hearing aid may be interfered with by other equipment even if that other equipment complies with CISPR emission requirements EMI EMC Compliance The UNIQUE hearing aid complies with the following EMC EMI standards Standard Test type Note 47 CFR Part 15 subpart C RF emissions US...

Page 42: ...rd Methods of measurement of Compatibility between wireless Communication Devices and Hearing Aids The device was tested in only one orientation that represents the longest length or worst case scenario This is acceptable because of the relative small size of the device compared to the wavelength of the RF used in the test Warning to hearing aid dispensers A hearing aid dispenser should advise a p...

Page 43: ...d be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds 132 decibels because there may be risk of impairing the remaining hearing of the hearing aid user Important notice for prospective hearing aid users Good health practice requires that a person with a hearing loss have a medi cal evaluation by a licensed physician preferably a physician who special izes...

Page 44: ...f a trial rental or purchase option pro gram Many hearing aid dispensers now offer programs that permit you to wear a hearing aid for a period of time for a nominal fee after which you may decide if you want to purchase the hearing aid Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician Federal law per mits a fully in...

Page 45: ...Directive 2014 53 EU The U FS contains a radio transmitter operating at 10 6 MHz 54dBmA m 10 m A copy of the Declaration of Conformity according to 2014 53 EU can be found at http global widex com doc N26346 Information regarding disposal Do not dispose of hearing aids hearing aid accessories and batteries with ordinary household waste Hearing aids batteries and hearing aid accessories should be d...

Page 46: ... to provide rea sonable protection against harmful interference in a residential installation This equip ment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio com munications However there is no guarantee that interference will not occur in a partic ular installation If this equipment doe...

Page 47: ...empt transmitter s receiver s that comply with Inno vation Science and Economic Development Canada s licence exempt RSS s Opera tion is subject to the following two conditions 1 This device may not cause interference 2 This device must accept any interference including interference that may cause un desired operation of the device L emetteur recepteur exempt de licence contenu dans le present appa...

Page 48: ...er 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 Cet emetteur ne doit pas etre co localises ou fonctionner en conjonction avec une autre antenne ou emetteur 48 ...

Page 49: ...logue item number Consult instructions for use The user instructions contain important cautionary information warn ings precautions and must be read before using the product Warning Text marked with a warning symbol must be read before using the product 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...

Page 50: ...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 50 ...

Page 51: ...51 ...

Page 52: ...WIDEX A S Nymoellevej 6 DK 3540 Lynge Denmark https www global widex com Manual no 9 514 0317 041 07 CIB number CIB350 Issue 2019 03 9 514 0317 041 07 ...

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