Atmos Audio Cube 31 Manual de usuario
Operating Instructions
ATMOS®
AudioCube31
English
0483
GA1GB.140201.0
2017-12Index02
2
Table of contents
1 Introduction ......................................................................................................4
1.1 Notesonoperatinginstructions ..............................................................................4
1.2 Explanationofpicturesandsymbols ......................................................................5
1.3 Intendeduse...............................................................................................................6
1.4 Function.......................................................................................................................6
1.5 Scopeofdelivery........................................................................................................7
1.6 TransportandStorage ..............................................................................................7
2 Hints for your safety.........................................................................................8
3 Setting up and starting up .............................................................................10
3.1 Deviceoverview....................................................................................................... 10
3.2 Systemrequirements ............................................................................................. 10
3.3 Installingandstartingup ....................................................................................... 11
3.3.1 Audiometerwithfreeeldloudspeaker......................................................... 11
3.3.2 Audiometerwithheadphones ......................................................................... 11
3.3.3 Hearingtestbooth............................................................................................. 11
3.4 Connectiondiagram ............................................................................................... 12
3.5 Usewithotherdevices ........................................................................................... 12
3.6 Connectingthedevice ............................................................................................ 14
3.7 Installingthesoftware............................................................................................ 14
3.8 InstallationoftheATMOS®PatSoft31.................................................................. 14
3.8.1 CallupOptiOns .................................................................................................... 15
3.8.2 Selectthestartwindow..................................................................................... 15
3.8.3 Settingthesection Waiting rOOm ...................................................................... 16
3.9 InstallationoftheATMOS®AudioCube31software.......................................... 16
4 Operation.........................................................................................................18
4.1 Ambientconditionsduringoperation .................................................................. 18
4.2 Switchingonthedevice.......................................................................................... 18
4.3 Switchingothedevice ......................................................................................... 18
4.4 PatientmanagementwiththeATMOS®PatSoft31 ............................................ 18
4.4.1 StartingtheATMOS®PatSoft31....................................................................... 18
4.4.2 ExittheATMOS®PatSoft31.............................................................................. 18
4.4.3 Recommendedprocedureatworkplaces ...................................................... 18
4.4.4 Gotoasection ................................................................................................... 18
4.4.5 Createanewpatient ......................................................................................... 19
4.4.6 Importingpatientdatamanually..................................................................... 19
4.4.7 Searchingpatientdata ...................................................................................... 20
4.4.8 Editingpatientdata ........................................................................................... 20
4.4.9 PlacethepatientdatainthesectionWaiting rOOm .......................................... 21
4.4.10 Callingupthediagnosticsoftware .................................................................. 22
4.4.11 Removethepatientdatafromthewaitingroom.......................................... 22
4.5 ATMOS®AudioCubesoftware............................................................................... 22
4.5.1 Softwareoverview ............................................................................................. 22
4.5.2 Setdefaultsettings............................................................................................ 24
4.5.3 Patientmanagement......................................................................................... 25
4.5.4 Prepareformeasurement................................................................................ 26
4.5.5 Measurementtoneaudiometry....................................................................... 27
4.5.6 Measurementspeechaudiometry .................................................................. 28
3Introduction
4.5.7 Illustrationofthemeasurement...................................................................... 28
4.5.8 Organizemeasurementdata ........................................................................... 29
5 Cleaning and disinfection ..............................................................................32
5.1 Cleaninganddisinfection....................................................................................... 32
5.2 Overviewhygienemeasures.................................................................................. 33
5.3 Recommendeddisinfectants................................................................................. 33
6 Maintenance and service...............................................................................35
6.1 Periodtests.............................................................................................................. 35
6.2 Dailyfunctioncheck................................................................................................ 36
6.3 Weeklyfunctioncheck............................................................................................ 37
6.4 Metrologicalcheck/electricalsafety.................................................................... 38
6.5 Partsreplacement................................................................................................... 39
6.5.1 SennheiserHDA280headphonecushions..................................................... 39
6.5.2 SennheiserHDA280headphonebowcushion .............................................. 39
6.5.3 HeadbowofthebonevibratorB71................................................................ 39
6.5.4 BonevibratorcableB71.................................................................................... 40
6.5.5 Mainsfuses......................................................................................................... 40
6.6 Sendinginthedevice.............................................................................................. 40
7 Troubleshooting..............................................................................................41
8 Accessories ......................................................................................................42
9 Spare parts and consumables .......................................................................43
10 Disposal............................................................................................................44
11 Technical data .................................................................................................45
12 Notes on EMC ..................................................................................................47
13 For your notes .................................................................................................51
4Introduction
1 Introduction
1.1 Notes on operating instructions
Theseoperatinginstructionscontainimportantnotesonhowtooperate
the ATMOS®AudioCube31safely,correctlyandeectively.
Theseoperatinginstructionsservenotonlyfornewoperatingpersonnel
tobeinstructedinitsuse,butalsoforuseasareferencemanual.Any
reprint-eveninextracts-onlyafterwrittenpermissionfromATMOS.
These operating instructions must always be kept available near
the device.
Care,periodtests,regularcleaningandproperapplicationareindis-
pensable.Theyguaranteetheoperationalsafetyandusabilityofthe
ATMOS®AudioCube31.
Maintenance,repairsandperiodtestsmayonlybecarriedoutby
personswhohavetheappropriatetechnicalknowledgeandarefamiliar
withtheproduct.Tocarryoutthesemeasuresthepersonmusthavethe
necessarytestdevicesandoriginalspareparts.
Perusechapter„2Hintsforyoursafety“onpage8beforeusingthe
deviceforthersttime.Thishelpsyouavoidpotentiallydangerous
situations.
The product ATMOS®AudioCube31bearsCEmarkingCE0483accord-
ingtotheECDirectiveofthecouncilformedicalproducts93/42/EECand
meetsthebasicrequirementsofappendixIofthedirective.
The product ATMOS®AudioCube31complieswithallapplicablere-
quirementsofthedirective2011/65/ECrestrictingtheuseofcertain
hazardoussubstancesinelectricalandelectronicequipment(“RoHS”).
Thedeclarationofconformityandourgeneralstandardtermsand
conditionscanbeobtainedonourwebsiteatwww.atmosmed.com.
ThequalitymanagementsystematATMOShasbeencertiedaccording
tointernationalstandardsENISO13485.
Theseoperatinginstructionsarevalidforthefollowingdevices:
• ATMOS®AudioCube31 512.2100.0
5Introduction
1.2 Explanation of pictures and symbols
In the operating instructions
DANGER
Warningofadangerwhichcausesimmediatedeathorseriousinjury.Observethe
necessarymeasures.
WARNING
Bewareofadangerwhichcancausedeathorseriousinjury.Observethenecessary
measures.
CAUTION
Bewareofadangerwhichcaneasilyhurtyou.Observethenecessarymeasures.
ATTENTION
Indicationofadangerwheretheproductorotheritemscouldbedamaged.Observe
thenecessarymeasures.
Warningofadangerwhichcancausedeathorseriousinjury.
Informationregardingpossiblematerialdamagewhichcouldbecaused.
Usefulinformationonthehandlingofthedevice.
1. Action.Gostepbystep.
Numeration.
»Resultofanaction.
On device and type plate
ApplicationparttypeB Thisproductcomplieswiththerelevant
requirementsofEUDirectives
SN Serialnumber Observeoperatinginstructions!
REF Ordernumber Manufacturingdate
Professionaldisposal. Manufacturer
1
WARNING!Dangeroffatalinjuryfromelectriccurrent.Pleaseobserve
thesafetyinstructionsforthepowerconnectiononyourdevice.
2
CAUTION!Dangerfromelectriccurrent,incorrectmeasurementresults
orthelevelistoohigh.Pleaseobservethesafetyinstructionsforthe
connectionoftheacoustictransducer.
3
CAUTION!DangerduetoproductswhichdonotcomplywithEN
60601-1.Electricshockispossible.Pleaseobservethesafetyinstruc-
tionsforcombinationoftheaudiometertootherdevices.
6Introduction
1.3 Intended use
Name: ATMOS®AudioCube31
Main function: Quantitativeandqualitativeelectro-acousticshearingtest
Medical indications / application:Testanddeterminationofthehearingability
Specication of the main function:Determinationofthehearingability(toneand
speechaudiometry,suitableforthediagnosticandclinicalapplication).
Application organ: Ear
Application time: Fortheshort-termapplicationonpatients(max.60minutes).
Application site: InclinicsandpracticesforENTdoctors.Theexaminationmayonlybe
performedbyhealthcareprofessionals.
Contraindications: None
The product is:active
Sterility: Notnecessary
Single-use product / reprocessing:Nosingleuseproduct
1.4 Function
Principle: Audiometryisthesubjectiveexaminationofthehearingability,forwhich
thereareseveraldierentmethods.Unlikeobjectiveaudiometry(tympanography/OAE/
BERA)theactivecooperationofthepersontobeexaminedisrequired.Theaudiometric
testsareperformedinasoundproofroom.
Measuring method: The ATMOS®AudioCube31appliesthetoneandspeechaudiome-
trybymeansofairandboneconductionaswellasinthefreeeld.
Tone audiometry:Theauditorythresholdisdeterminedwithatoneaudiogram.The
patientispresentedwithtonesofdierentfrequencies.Thevolumeofthetoneisgrad-
uallyincreaseduntilthepatientcanperceivethetone,theso-calledthreshold.Initially
thistestisperformedbymeansofairandthenbyboneconduction.Togethertheresult
isthetoneaudiogram.
Nowitcanbedeterminedwhetherthereisaconductivehearingloss(hearingdefectin
themiddleear)orasensorineuralhearingloss(hearingdefectintheinnerear)orifitis
acombinationofboth.Ifthereisadierenceinhearingbetweenbothsides,maskingis
requiredforthenon-testear.
Alltheimportantsupra-thresholdtestsareintegratedintheATMOS®AudioCube31,
theyindicateinwhichpartoftheacousticorganoftheinnereardamageexists.
Speech audiometry: Speechaudiometryisnotonlythehearingoftonesbutalsothe
perceptionofcomplexacousticinformatione.g.words,numbersorsentenceswhichthe
patientmustthenrepeat.
Country-specicspeechtestscanbeusedviaaCDorharddisk.
Signicance:Fromthecombinationofsoundandspeechaudiometry,thedoctorknows
inwhichfrequencyrangesthepatienthashearingproblemsandwhattherapeutic
approacheshavetofollowfromthem.
Themeasurementofthetoneandspeechaudiometrytogetherwiththemeasurement
oftheotoacousticemissions(OAE)andthederivationofacousticallyevokedpotentials
(BERA)aswellasthetympanometrywithastapediusreexmeasurementallowa
preciseclaricationofthehearing.Withthehelpofthesetestsitispossibletoelicitthe
location,typeandextentofahearingloss.
Themeasurementresultscanbesavedinapatientrelateddatabase,beprintedor
integratedintoadoctor'spracticesoftwaresystemrespectivelyintoahospitalinforma-
tionsystem(HIS).
7Introduction
1.5 Scope of delivery
Thischapterdescribesthestandardscopeofdeliveryinthefullversion.Thescopeof
deliveryofyourdevicecanbefoundinthedeliverynote.
ATMOS®Audio
Cube31
1xpowercable 1xhead-
phones
1xbone
vibrator
1xheadset
withexaminer
microphone
1xpatientre-
sponsebutton
1xUSB2.0
cable
1xSoftware
(USBash
drive)
1xoperating
instructions
1.6 Transport and Storage
Transportatlowtemperaturescandamagethedevice.
1. Priortostart-uptheunitmustacclimatizeforupto6hoursatroomtemperature.
Transportthedeviceonlyinashippingcarton,whichispaddedandoerssufficient
protection.
Ifdamageoccursduringtransport:
1. DocumentandreportthedamagetoATMOS.
2. FillintheformQD434“customercomplaint/returnshipment”.Thisisenclosedto
the product.
3. SendthedevicetoATMOS(Chapter„6.6Sendinginthedevice“onpage40).
Ambient conditions for transport and storage
• Temperature: -10°Cto+45°C
• Airhumidity: 30%to90%
• Airpressure: 70kPato106kPa
8Hintsforyoursafety
2 Hints for your safety
ThesafetyoftheATMOS®AudioCube31complieswithalltherecognizedrulesof
technologyandthedirectivesoftheMedicalDevicesAct.
Readandfollowthesafetyinformationcarefullybeforeusingtheproduct.
General safety information
IfyouwishtooperatetheATMOS®AudioCube31incombinationwithnon-medical
products,(e.g.PC,printer),observethechapter„3.5Usewithotherdevices“onpage
12.
ThedevicehasapplicationpartsfromtypeB.
Dangers for users, patients and third parties
Protect yourself against an electric shock!
Burns,cardiacarrhythmiasandevendeatharepossible.
• Priortoeachusecheckwhetherthedeviceorpowercablearedamaged.Never
operatetheunit,ifitshowsanyobvioussafetydefects.Inthiscasecleanthedevice
andsenditintoATMOSforrepair.
• Disconnectthedevicefromthemainspowersupplypriortocleaningordisinfection.
• Priortoswitchingthedeviceon/oremovethetransducerfromthepatientor
examiner.
• Plugoutthetransducerbeforeyourepairit.Firstremovethetransducercablefrom
theaudiometerbeforeyouloosenthecablefromthetransduceritself.
• Donotoperatethedeviceifithasbeendropped.Inthiscasecleanthedeviceand
senditintoATMOSforrepair.
• Onlyconnectthedevicetoapowersupplywithacorrectlyinstalledprotective
conductor.
• OnlyuseaccessoriesandsparepartsfromATMOS.
• Assembly,newsettings,alterations,extensionsandrepairsmayonlybecarriedout
byauthorizedpersons.
• Payattentiontotheperiodtestsinchapter„6.1Periodtests“onpage35.
Explosion and re hazard!
Burnsandinjuriesarepossible.
• NeveroperatetheproductATMOS®AudioCube31inexplosion-hazardousareasor
areaswhichareoxygenated.
• OnlyuseoriginalaccessoriesandoriginalsparepartsfromATMOS.
Reduce the risk of infection for you and your patients!
Diseasescouldbetransmitted.
• Cleananddisinfecttheproductasdescribedinchapter„5Cleaninganddisinfection“
onpage32.
• Usestandardprotectivecoversforheadphones.
• Replacetheearcushionsandheadbandpadsatregularintervals.
9Hintsforyoursafety
Avoid misapplication or incorrect diagnosis.
Patient’searandhearingcouldbecontaminated,injuredordamaged.
• Theproductmayonlybeappliedbymedicallytrainedsta.
• Adiagnosismayonlybemadebypersonswiththeappropriatemedicaltraining.
• Onlyusetheproductinasoundproof,audiologicalroomwithanacousticlevel
<40dBSPL.
• Priortouseadailyfunctioncheckmustbeperformed.
• Onlyadjustthelevelto>80dBHLifitwasprescribedbythedoctor.
• Onlyremoveorconnectthetransducertotheaudiometerwhenitisswitchedo.
Otherwisethetransducerscrackle.
• Onlyconnecttheacoustictransducerstothesocketsprovided.
• Assoonasyoureplaceoruseadierenttransducerthenthedevicemustalwaysbe
recalibrated.InthiscasecontactATMOS.
• Pleasepayattentiontotheperiodtestsinchapter„6.1Periodtests“onpage35.
• OnlyuseoriginalaccessoriesandoriginalsparepartsfromATMOS.
• Assembly,newsettings,modications,extensionsandrepairsmayonlybecarried
outbypersonswhoareauthorizedbyATMOS.
Onlyafullyfunctionalproductmeetsthesafetyrequirementsofusers,patientsand
thirdparties.Thereforereadthefollowinginstructionscarefully:
Avoid damage to the device
Observetheambientconditionsregardingtransport,storageandoperation.
Takecarethatnoliquidpenetratesthedevice.Ifliquidhaspenetratedthedeviceitmay
nolongerbeoperated.InthiscasecleanthedeviceandsenditintoATMOSforrepair.
Thedevicemayonlybeconnectedtothemainspowersupplywhenmainsvoltageand
frequencyofdeviceandmainspowersupplycorrespond.
Onlyusepropermainsconnectionsandextensioncords.
Donottwistorbendthewires.
Protectthedevicefromshockandvibration.
10 Setting up and starting up
3 Setting up and starting up
3.1 Device overview
Front view
1 2
1LEDStatus
2LEDPower
Rear side
43
3Connectionpowercable
4On/Oswitch
Theconnectionsaredescribedinchapter„3.4Connectiondiagram“onpage12.
3.2 System requirements
Inappropriate hardware
Thepatientcannotbeexaminedandtreated.
• Observetheminimumrequirementsforthehardware.
Operating system WindowsVista/7/8
Free hard-drive capacity min.50GB
CPU performance min.2GHz
Available RAM min.4GBRAM
Graphic resolution min.1600x900
Connections min.1USBconnection,furtherUSBinterfacesfor
printer,optional
CAUTION
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