User Guide Virto V - Phonak

14. Compliance informationEurope:Declaration of ConformityHereby Phonak AG declares that this Phonak productmeets the requirements of the Medical Devices Directive93/42/EEC as well as the Radio and TelecommunicationsTerminal Equipment Directive 1999/5/EC. The full text ofthe Declaration of Conformity can be obtained from themanufacturer or the local Phonak representative whoseaddress can be taken from the list on www.phonak.com(Phonak worldwide locations).Australia/New Zealand:Indicates a device’s compliance with applicableRadio Spectrum Management’s (RSM) andAustralian Communications and Media Authority(ACMA) regulatory arrangements for the legal salein New Zealand and Australia.The compliance label R-NZ is for radio productssupplied in the New Zealand market underconformity level A1.31

The wireless models listed on page 2 arecertified under:Phonak Virto V-10 O, models M / P / SPUSAFCC ID: KWC-ITEV10OCanadaIC: 2262A-ITEV10OPhonak Virto V-10, models M / P / SPUSAFCC ID: KWC-ITEV10CanadaIC: 2262A-ITEV10Phonak Virto V-13 & V-312, models M / P / SP / UPUSAFCC ID: KWC-ITEV13CanadaIC: 2262A-ITEV1332

Notice 1:This device complies with Part 15 of the FCC Rulesand with RSS-210 of Industry Canada. Operation issubject to the following two conditions:1) this device may not cause harmful interference, and2) this device must accept any interference received,including interference that may cause undesired operation.Notice 2:Changes or modifications made to this device notexpressly approved by Phonak may void the FCCauthorization to operate this device.Notice 3:This device has been tested and found to comply withthe limits for a Class B digital device, pursuant to Part 15of the FCC Rules and ICES-003 of Industry Canada.These limits are designed to provide reasonable protectionagainst harmful interference in a residential installation.This device generates, uses and can radiate radiofrequency energy and, if not installed and used inaccordance with the instructions, may cause harmful33

interference to radio communications. However, thereis no guarantee that interference will not occur in aparticular installation. If this device does cause harmfulinterference to radio or television reception, which canbe determined by turning the equipment off and on, theuser is encouraged to try to correct the interference byone or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the deviceand receiver. Connect the device into an outlet on a circuitdifferent from that to which the receiver is connected. Consult the dealer or an experienced radio/TVtechnician for help.34

15. Information and descriptionof symbolsWith the CE symbol, Phonak AG confirmsthat this Phonak product – includingaccessories – meets the requirements of theMedical Devices Directive 93/42/EEC as well asthe R&TTE Directive 1999/5/EC on radio andtelecommunications equipment. The numbersafter the CE symbol correspond to the code ofcertified institutions that were consulted underthe above-mentioned directives.This symbol indicates that the productsdescribed in these user instructions adhere tothe requirements for an applied part of Type Bof EN 60601-1. The surface of the hearing aidis specified as an applied part of Type B.Indicates the medical device manufacturer, asdefined in EU Directive 93/42/EEC.35

During transportation keep dry.This symbol indicates that it is important forthe user to read and take into account therelevant information in these user guides.This symbol indicates that it is important forthe user to pay attention to the relevantwarning notices in these user guides.Important information for handling andproduct safety.Operatingconditions36The product is designed such that it functionswithout problems or restrictions if used asintended, unless otherwise noted in theseuser guides.

Temperature during transportationand storage: –20 to 60 Celsius(–4 to 140 Fahrenheit).Humidity during transportation: Up to 90%(non condensing).Humidity during storage: 0% to 70%, if not inuse. See instruction in chapter 17.2 regardingdrying the hearing aid after use.Atmospheric pressure: 200 hPA to 1500 hPaThe symbol with the crossed-out garbagebin is to make you aware that this hearingaid may not be thrown away as normalhousehold waste. Please dispose of old orunused hearing aids, at waste disposal sitesintended for electronic waste, or give yourhearing aid to your hearing care professionalfor disposal. Proper disposal protects theenvironment and health.37

16. TroubleshootingProblemHearing aid not functioningCausesFlat batteryBlocked speakerBattery not inserted correctlyHearing aid switched offHearing aid whistlesHearing aid not inserted correctlyEarwax in ear canalHearing aid not loud enoughor distortedVolume too loudLow batteryBlocked speakerVolume too lowPhysical hearing conditionhas changedHearing aid plays two beepsIndication for low batteryHearing aid switches on & off(intermittent)Moisture on battery orhearing aidIf the problem persists, contact you hearing careprofessional for assistance38

What to doChange battery (chapter 1 5)Clean speaker openingInsert battery correctly (chapter 1 5)Switch hearing aid on by completely closing the battery door(chapter 4)Insert hearing aid correctly (chapter 6)Contact your ENT/GP or hearing care professionalDecrease volume (chapter 8 9)Change battery (chapter 1 5)Clean speaker openingTurn volume up if volume control available (chapter 8 9)Contact you hearing care professionalChange battery within the next 30 minutes (chapter 1 5)Wipe battery and hearing aid with dry cloth39

17. Important safety informationPlease read the information on the following pages beforeusing your hearing aid.A hearing aid will not restore normal hearing and will notprevent or improve a hearing impairment resulting fromorganic conditions. Infrequent use of a hearing aid doesnot permit a user to attain full benefit from it. The use ofa hearing aid is only part of hearing habilitation and mayneed to be supplemented by auditory training andinstruction in lipreading.40

17.1 Hazard warningsThe intended use ofhearing aids is to amplifyand transmit sound to theears and herebycompensate for impairedhearing. The hearing aids(specially programmed foreach hearing loss) mustonly be used by theintended person. Theyshould not be used by anyother person as they coulddamage hearing.Changes or modificationsto the hearing aid thatwere not explicitlyapproved by Phonak arenot permitted. Suchchanges may damage yourear or the hearing aid.Do not use the hearingaids in explosive areas(mines or industrial areaswith danger of explosions,oxygen-rich environmentsor areas where flammableanesthetics are handled).Hearing aid batteries aretoxic if they are swallowed!Keep out of reach ofchildren and mentallychallenged people or pets.If batteries are swallowed,consult your physicianimmediately!41

If you feel pain in orbehind your ear, if it isinflamed or if skinirritation and acceleratedaccumulations of earwaxoccur, please check withyour hearing careprofessional or physician.Hearing programs in thedirectional microphonemode reduce backgroundnoises. Please be awarethat warning signals ornoises coming frombehind, e. g. cars, arepartially or entirelysuppressed.42This hearing aid is not forchildren below 36 months.It contains small parts thatcan cause choking, ifswallowed by children.Keep out of reach ofchildren and mentallychallenged people or pets.If swallowed, consult aphysician or hospitalimmediately.External devices may onlybe connected if they havebeen tested in accordancewith correspondingIECXXXXX standards. Onlyuse accessories approvedby Phonak AG, to avoid anyelectrical shock.

The following is onlyapplicable for persons withactive implantable medicaldevices (i.e. pacemakers,defibrillators, etc.):Keep the wireless hearingaid at least 15 cm(6 inches) away from theactive implant. If youexperience any interference,do not use the wirelesshearing aids and contactthe manufacturer of theactive implant. Please, notethat interference can alsobe caused by power lines,electrostatic discharge,airport metal detectors etc.Keep magnets (i.e. batteryhandling tool, EasyPhonemagnet, etc.) at least15 cm (6 inches) awayfrom the active implant.43

17.2 Information on product safetyNever immerse your hearingaid in water! Protect it fromexcessive moisture. Alwaysremove your hearing aidbefore showering, bathing,or swimming, as the hearingaid contains sensitiveelectronic parts.Protect your hearing aidfrom heat (never leave neara window or in the car).Never use a microwaveor other heating devicesto dry your hearing aid.Ask your hearing careprofessional about suitabledrying methods.When you are not usingyour hearing aid, leave thebattery door open so thatany moisture can evaporate.Make sure that you alwayscompletely dry yourhearing aid after use. Storethe hearing aid in a safe,dry and clean place.44

Do not drop your hearingaid! Dropping onto a hardsurface can damage yourhearing aid.Always use new batteriesfor your hearing aid. Incase a battery is leaking,replace it immediatelywith a new one to avoidany skin irritation. Youcan return used batteriesto your hearing careprofessional.The batteries used in thesehearing aids should notexceed 1.5 Volts. Please donot use silver-zinc or Li-ion(lithium-ion) rechargeablebatteries as these maycause severe damage toyour hearing aids. Thetable in chapter 5 explainsexactly which type ofbattery your particularhearing aids require.Remove the battery ifyou are not using yourhearing aid for a longperiod of time.45

Special medical or dentalexamination includingradiation described below,may adversely affect thecorrect functioning of yourhearing aids. Remove andkeep them outside theexamination room/areabefore undergoing:Medical or dentalexamination with X-ray(also CT scan).Medical examinations withMRI/NMRI scans, generatingmagnetic fields.Hearing aids don’t need tobe removed when passingsecurity gates (airportsetc.). If X-ray is used at all,it will be in very low doses,and will not affect thehearing aids.46Do not use your hearingaid in areas whereelectronic equipmentis prohibited.

18. Important information: Cell phonesSome hearing aid users have reported a buzzing soundin their hearing aids when they are using cell phones.According to the ANSI 63.19 (American NationalStandard Methods of Measurement of Compatibilitybetween Wireless Communications Devices and HearingInstruments) standard, the compatibility of a particularhearing aid and cell phone can be predicted by addingthe rating for the hearing aid immunity to the rating forthe cell phone emissions. The sum of the hearing aidrating (e.g. M2/T2 2) and the telephone rating(e.g. M3/T3 3) is 5, and any combination that equals5 will provide “normal use”; a sum of 6 or greater wouldindicate “excellent performance”. The equipmentperformance measurements, categories and systemclassifications are based upon the best informationavailable but cannot guarantee that all users will besatisfied. The immunity of this hearing aid is at leastM2/T2.47

Note: the performance of individual hearing aids mayvary with individual cell phones. Therefore, please trythe hearing aid with your cell phone or, if you arepurchasing a new phone, be sure to try it with yourhearing aid prior to purchase. For additional guidance,please ask your hearing care professional for the bookletentitled “hearing aid compatibility with digital wirelesscell phones”.48

19. For the US market only, complieswith the FDA regulationsWarning to Hearing Aid DispensersA hearing aid dispenser should advise a prospectivehearing aid user to consult promptly with a licensedphysician (preferably an ear specialist) before dispensinga hearing aid if the hearing aid dispenser determinesthrough inquiry, actual observation, or review of anyother available information concerning the prospectiveuser, that the prospective user has any of the followingconditions:(i) Visible congenital or traumatic deformity of the ear.(ii) History of active drainage from the ear within theprevious 90 days.(iii) History of sudden or rapidly progressive hearingloss within the previous 90 days.(iv) Acute or chronic dizziness.49

(v) Unilateral hearing loss of sudden or recent onsetwithin the previous 90 days.(vi) Audiometric air-bone gap equal to or greater than15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.(vii) Visible evidence of significant cerumenaccumulation or a foreign body in the ear canal.(viii) Pain or discomfort in the ear. Special care should beexercised in selecting and fitting a hearing aid whosemaximum sound pressure level exceeds 132 decibelsbecause there may be risk of impairing the remaininghearing of the hearing aid user. (This provision isrequired only for those hearing aids with a maximumsound pressure capability greater than 132 decibels(dB).)Important Notice for Prospective Hearing Aid UsersGood health practice requires that a person with ahearing loss have a medical evaluation by a licensedphysician (preferably a physician who specializes indiseases of the ear) before purchasing a hearing aid.50

Licensed physicians who specialize in diseases of the earare often referred to as otolaryngologists, otologists orotorhinolaryngologists. The purpose of medicalevaluation is to assure that all medically treatableconditions that may affect hearing are identified andtreated before the hearing aid is purchased.Following the medical evaluation, the physician will giveyou a written statement that states that your hearingloss has been medically evaluated and that you may beconsidered a candidate for a hearing aid. The physicianwill refer you to an audiologist or a hearing aiddispenser, as appropriate, for a hearing aid evaluation.The audiologist or hearing aid dispenser will conduct ahearing aid evaluation to assess your ability to hear withand without a hearing aid. The hearing aid evaluationwill enable the audiologist or dispenser to select and fita hearing aid to your individual needs.If you have reservations about your ability to adapt toamplification, you should inquire about the availabilityof a trial-rental or purchase-option program. Manyhearing aid dispensers now offer programs that permit51

you to wear a hearing aid for a period of time for anominal fee after which you may decide if you want topurchase the hearing aid.Federal law restricts the sale of hearing aids to thoseindividuals who have obtained a medical evaluationfrom a licensed physician. Federal law permits a fullyinformed adult to sign a waiver statement declining themedical evaluation for religious or personal beliefs thatpreclude consultation with a physician. The exercise ofsuch a waiver is not in your best health interest and itsuse is strongly discouraged.Children with Hearing LossIn addition to seeing a physician for a medicalevaluation, a child with a hearing loss should bedirected to an audiologist for evaluation andrehabilitation since hearing loss may cause problems inlanguage development and the educational and socialgrowth of a child. An audiologist is qualified by trainingand experience to assist in the evaluation andrehabilitation of a child with a hearing loss.52

20. Important notice for ProspectiveNoise Generator usersThe Tinnitus Balance noise generator is a broadbandsound Generator which may have been enabled in yourhearing aid. It provides a means of sound enrichmentthat can be used as part of a personalized tinnitusmanagement program to provide temporary relief fromtinnitus. It should always be used as prescribed byyour audiologist. The underlying principle of soundenrichment is to provide supplementary noisestimulation which can help defocus your attention fromyour tinnitus and avoid negative reactions. Soundenrichment, coupled with instructional counseling, is anestablished approach to managing tinnitus.Good health practice requires that a person reportingtinnitus have a medical evaluation by a licensed earphysician before using a sound generator. The purposeof such an evaluation is to ensure medically treatableconditions that may be causing tinnitus are identifiedand treated prior to using a sound generator.53

Should you develop any side effects whilst using thenoise generator such as headaches, nausea, dizziness orheart palpitations or experience a decrease in auditoryfunction, you should discontinue use and seek amedical evaluation.According to OSHA (Occupational Safety & HealthAdministration, U.S. Department of Labor) regulations,the volume of the noise generator can be set to a levelwhich could lead to permanent hearing damage whenused for a prolonged period of time. Should the noisegenerator be set to such a level in your hearing aid, youraudiologist will advise you of the maximum amount oftime per day you should use the noise generator. Thenoise generator should never be used at uncomfortablelevels.For more information visit www.phonak.com54

Notes

www.phonak.comYour hearing care professional:029-0365-03/V1.01/2017-04/FO Phonak AG All rights reservedManufacturer:Phonak AGLaubisrütistrasse 28CH-8712 StäfaSwitzerland

2015 2015 2015 2015 2015 2015 2015 2015 2015 2015 2015 2015 2015 2015 2015 2015 . Removal handle Sound output / wax protection system. 11 Virto V-10 Custom made shell Battery door Volume control (optional) Push button Removal handle . Before using