MADSEN Itera II

1 MADSEN Itera ,storedinaretrievalsystem,ortransmitted, inanyformorbyanymeans,electronic,mechani cal,photocopying,recording,orotherwise,w ithoutthepriorwrittenconsentofGN Otometrics 2015,GN Otometrics A/SPublishedinDenmarkbyGN Otometrics A/S,DenmarkAllinformation,illustrations, Otometrics Itera II, MADSEN OTOflex100,OTOsuite,AURICAL FreeFit,AURICALV isible Speech,MADSENA stera , MADSEN Xeta,ICSC hartr200 VNG/ENG,ICSC hartrEP,OTOcam 300, MADSEN AccuScreen, MADSEN AccuLink,ICS AirCal,AURICAL Aud,AURICAL HIT,ICS Impulse,OTObaseandMADSENC apella areeitherregisteredtrademarksortrademark sofGN Otometrics (117479) ,cleaningandcalibration1313 Otherreferences1514 Technicalspecifications1515 Definitionofsymbols2216 Warningnotes2317 Manufacturer24 Otometrics-MADSENI teraII31 DevicedescriptionMADSENI teraIIisanaudiometerfortestingaperson' , ,variousspecialtestssuchasSISI,Stenger,A BLB(Fowler),andHISareavailable.

2 MADSENI teraIIcanbeusedinconnectionwiththeOTOsui teAudiometryModulesoftwareforonlinemonit oringoftestresults,dataexportandstorage, printing, MADSENI teraIIcanbeusedasaportableinstrumentoras adesktopunit(fixedinstallation).Operatio nThefrontpanelbuttonshaveindicatorlights ,whichclearlyshowthedevice' , :audiologists, ,CautionandNoteTodrawyourattentiontoinfo rmationregardingsafeandappropriateuseoft hedeviceorsoftware,themanualusespre-caut ionarystatementsasfollows:Warning , ,theoriginalpackingmaterialwillprotectag ainstdamagedur-ingtransport, , , (CalibrationCertificate),makesurethatthe transducers(headphonesandboneoscillator) arethecorrectones, ,seetheOTOsuite InstallationGuide,whichyoucanfindontheOT Osuiteinstall-ationmedium(diskormemoryst ick).

3 MADSENI teraIIisfullyassembledondelivery, ToconnectMADSENI teraIItothePC, ( ). SeePoweringthedevice SeeConnectingMADSENI teraIItoOTOsuite ,seetheMADSENI teraII :Otometrics-MADSENI teraII53 Unpacking Yellow:Operatordesktopmicrophone Green:Operatormonitorheadset,headphones Pink:Operatormonitorheadset,boommicropho ne (AC), Whenyouconnectotherelectricalequipmentto MADSENI teraII,rememberthatequipmentthatdoesnotc omplywiththesamesafetystandardsasMADSENI teraIIcanleadtoageneralreductioninthesys tem' , ,ifMADSENI teraIIisturnedonwhenyouopentheControlPan elinOTOsuite, , , , RuntheOTOsuiteConfigurationWizardtoconne cttoandsetupcommunicationwithMADSENI teraII:SelectTools> ,thefollowingpointsmustbeconsidered: Useofconnectedequipmentinapatientenviron ment.

4 2012,ANSI/AAMIES60601-1(2005)+AMD1(2012) (2014).SeeGeneralwarningnotes ,seetheMADSENI teraII Connecttherightandleftcables(redandblue) ,connectthemtotherightandleftSFsocket. Toverifythecalibration,press[AC]/[SF] 5foranoverviewoftheconnectionpanel. : Gooseneck,or EXTERNALMIC/MONITORHEADSET WithPowerAmplifier (com-binedaudiogram) , ,500Hz. , , ' Iftheheadphonesarenotplacedproperly, ' , ' ; ' Forunmaskedbonethresholds, ,positiontheotherendoftheboneoscillatorh eadbandoverthepatient'stempleontheopposi tesideoftheheadsothattheheadbandoftheear phonesandboneoscillatorfitonthepatient' , , , , ,transducer,unmasked/masked, ,didyoutest: Bothears Airconduction Boneconduction Masking Threshold, , , , , , ,transducer,unmasked/masked, ,cleaningandcalibrationWarning , Forthesakeofsafetyandinordernottovoidthe warranty, ,makeadetaileddescriptionofthedefect(s) Removedustusingasoftbrush.

5 Useasoft, HeadphonesUseanon-alcoholbasedwipe( )tocleantheheadphonesbetweenpatients. EartipsforInsertEarphonesTheeartipsaredi sposableandthereforeshouldnotbecleanedor re-used. BoneoscillatorCleantheboneoscillatorbetw eenpatients, , , ,headphones,boneoscillators, Notethatcalibrationhasbeenperformedonlyo nthetransducerssupplied!Ifyouwishtousean yothertransducerfortestingwiththedevice, ,cleaningandcalibration13 OtherreferencesFormoreinformation,seethe onlineHelpinOTOsuite, ,seetheOTOsuite InstallationGuide,whichyoucanfindontheOT Osuiteinstall-ationmedium(diskormemoryst ick). Otometrics :12standard125-8000and12500 HzBC:250-8000 HzstandardfrequenciesInsertphones125-600 0 HzstandardfrequenciesAccuracy:Betterthan 1%.

6 ModulationFM(Warble) :5,4,3,1, , , :betterthan3dBHLB etweentwoconsecutiveattenuatorpositions: 5 :-10to120dBHLatmid-frequenciesBC:-10to70 dBHLatmid-frequenciesHISfunctionLowpassf requencies:250Hz,500Hz,1kHzor2kHzHighpas sfrequencies:1kHz,2kHz,3kHzor4kHzAmplifi cationoptions:0,5,10,15,20, :130dBSPL(forTDH39) :50dBSPLM askingNarrowbandnoise,SpeechnoiseandWhit enoise(Widebandnoise)Totalharmonicdistor tionAir< <5%SelectabletransducersAC:TDH39,ME-70,a ndOtometricsinsertphonesBC:NB-71,B-71(Ma stoid/Forehead)SF:TDH39,ME-70,Otometrics insertphones,Free- :2xmonojack,1/4"BC:1xmonojack,1/4"SF:2xm onojack,1/4"ExternalinputsCD/ ,10k2 ,2x8- , :10kand600 .16 Otometrics-MADSENI teraII14 : , (8-poleDINhorseshoe) , :8databit,1stopbitParity:EqualBaudrate:9 600,19200,38400,57600 BaudProtocol:XON/XOFFT ransportandstorageTemperature:-40 Cto+70 C(-40 Fto+158 F)Airhumidity:10%to90%,non-condensingAir pressure500hPato1060hPaOperatingenvironm entModeofoperation:ContinuousTemperature :+10 Cto+35 C(50 Fto+95 F)Airhumidity:30%to90%,non-condensingAir pressure860hPato1060hPa.

7 (Operationintemperaturesexceeding-20 C(-4 F)or+60 C(140 F)maycausepermanentdamage.)Warm-uptime< , , , ,100-120 VAC,200-240 VAC,50/60 HzPowerconsumption<60 VAFusesT1AH/250 VStandardsAudiometer:EN60645-1,EN60645-2 ,EN60645-4, :2012,ClassI,TypeB;IEC60601-1-6:2010;IEC 62366:2007; :2014;ANSI/AAMIES60601-1(2005)+AMD1(2012 )EMC:IEC60601-1-2:2007 , TDH39headphones ME-70headphones18 Otometrics-MADSENI teraII14 Technicalspecifications Otometricsinsertphones Boneoscillators:NB-71,B-71 Soundfieldloudspeakers Monitorheadphoneswithboommicrophone Goosenecktalk-overmicrophones(onerightan doneleftmicrophone)forspeechaudiometryan dHearingInstrumentSimulation Talkbackmicrophone PatientResponder(s) Mainscable PowersupplycablefromMADSENI teraIItoCDplayer PA210poweramplifierforfree-fieldtesting Wallmountkitforamplifier Connectioncables Audiogrampad MADSENI teraIIReferenceManual (ElectromagneticCompatibility ,theinstallationandoperatinginstructions providedinthisdocumentshouldbefollowedcl osely.)

8 Portableandmobilehigh-frequencycommunica tiondevices,suchasmobilephones, 'sdeclaration-electromagneticemissions , :Theemissionscharacteristicsofthisequipm entmakeitsuitableforuseinindustrialareas andhospitals(CISPR11classA).Ifitisusedin aresidentialenvir-onment(forwhichCISPR11 classBisnormallyrequired) , ' (ESD)IEC61000-4-2+/-6kVcontact+/-8kVair+ /-6kVcontact+/-8kVairFloorsshouldbewood, ,therelativehumidityshouldbeatleast30%.P owerfrequency(50/60Hz)magneticfieldIEC61 000-4-83A/m3 ' ,includingcables, :d= ,wherePisthemaximumoutputpowerratingofth etransmitterinwatts(W)accordingtothetran s-mittermanufactureranddistherecommended separationdistanceinmetres(m).Fieldstren gthsfromfixedRFtransmitters,asdetermined byanelectromagneticsitesurvey, :20 Otometrics-MADSENI teraII14 TechnicalspecificationsNote1 , (industrial,scientificandmedical) ; ; ; , ,anadditionalfactorof10 ,suchasbasestationsforradio(cellular/cor dless)telephonesandlandmobileradios,amat eurradio, , , ,additionalmeasuresmightbenecessary,such asreorientingorrelocatingMADSENI teraII.

9 ,fieldstrengthsshouldbelessthan3 ,therecommendedseparationdistancedinmete rs(m)canbeestimatedusingtheequa-tionappl icabletothefrequencyofthetransmitter,whe rePisthemaximumoutputpowerratingofthetra nsmitterinwatts(W) , (WEEE).Allelectricalandelectronicproduct s,batteries, , (2011/65/EC).MEDICAL-GeneralMedicalEquip mentastoelectricalshock,fireandmechanica lhazardsonlyinaccord-ancewithANSI/AAMIES 60601-1(2005)+AMD1(2012),IEC60601-1-6, (2014) (2011). , ,ifapplicable, 22andGeneralwarningnotes (gases) ,burnt, ,accessoriesconnectedtotheequipment' ,itisrecommendedthatcalibrationbeperform ediftheequipmenthassufferedanypotentiald amage( ).Notethatcalibrationhasbeenperformedonl yonthetransducerssupplied!Ifyouwishtouse anyothertransducerfortestingwiththedevic e, , , , , ,thefol-lowingpointsmustbeconsidered: Useofconnectedequipmentinapatientenviron ment :2012,ANSI/AAMIES60601-1(2005)+AMD1(2012 ) (2014).

10 , :2012,computerandprintermustbeplacedouto freachoftheclient, , Otometrics A/SHoerskaetten9,2630 TaastrupDenmark(+45457555557+ ,reliability,andperformanceoftheequipmen tonlyif: Allassemblyoperations,extensions,re-adju stments,modificationsorrepairsarecarried outbytheequipmentman-ufacturerorpersonne lauthorizedbythemanufacturer. Theelectricalinstallationtowhichtheequip mentisconnectedcomplieswithEN/IECrequire ments.)