KONICA MINOLTA AERODRP5 AeroDR SYSTEM 2 User Manual Short Term Confidential 1

KONICA MINOLTA, Inc. AeroDR SYSTEM 2 Short Term Confidential 1

Contents

(Short-Term Confidential) User Manual_1

0197Operation ManualEN 01A45YBD01EN0120131220CTDIRECT DIGITIZER AeroDR SYSTEM 2Operation ManualSYSTEM 2DIRECT DIGITIZER
3ContentsChapter 3General Operations          453.1 Startupandshutdown...............463.1.1 Startupsequenceofthisdevice. . . . . 463.1.2 Startupofthisdevice. . . . . . . . . . . . . 463.1.3 Shutdownsequenceofthisdevice. . 483.1.4 Shutdownofthisdevice. . . . . . . . . . . 493.2 OperationofAeroDRDetector. . . . . . . . . 513.2.1 Exposure......................513.2.2 AeroDRDetectororientation. . . . . . . 523.2.3 Precautionsforexposure. . . . . . . . . . 523.3 ChargingofAeroDRDetector. . . . . . . . . 563.3.1 ChargingwithAeroDRBatteryCharger. . . . . . . . . . . . . . . . . 563.3.2 ChargingwithAeroDRBatteryCharger2......................573.3.3 Chargingwiththewiredcable. . . . . . 593.3.4 Chargingtimeguide. . . . . . . . . . . . . . 593.3.5 AeroDRDetectorchargingdisplay...593.4 RegistrationandselectionoftheAeroDRDetector..........................603.4.1 RegistrationwithAeroDRBatteryCharger.......................603.4.2 RegistrationwithAeroDRBatteryCharger2......................603.4.3 Registrationwiththewiredcable. . . . 613.4.4 SelectionoftheAeroDRDetector. . . 613.4.5 ManualselectionoftheAeroDRDetector.......................623.5 Calibration........................633.6 PositiontoafxAeroDRDetectoridenticationlabel. . . . . . . . . . . . . . . . . . 64Chapter 4Status (LED) Display         654.1 LEDdisplayofrespectivedevices. . . . . . 664.1.1 AeroDRDetector. . . . . . . . . . . . . . . . 664.1.2 AeroDRInterfaceUnit. . . . . . . . . . . . 674.1.3 AeroDRInterfaceUnit2. . . . . . . . . . . 684.1.4 AeroDRGeneratorInterfaceUnit....694.1.5 AeroDRBatteryCharger. . . . . . . . . . 704.1.6 AeroDRBatteryCharger2. . . . . . . . . 714.1.7 AccessPoint . . . . . . . . . . . . . . . . . . . 72Chapter 5Troubleshooting            735.1 Supportowduringtrouble...........745.2 Variousproblemsandcountermeasures. . 765.2.1 AeroDRDetector. . . . . . . . . . . . . . . . 765.2.2 AeroDRInterfaceUnit. . . . . . . . . . . . 78Introduction                 5Introduction..............................6IndicationsforUse. . . . . . . . . . . . . . . . . . . . . . . 6Summaryofusabilityspecications(forIEC/EN60601-1-6,IEC/EN62366). . . . . . . 7Disclaimer..............................7Trademark.............................8AeroDRSYSTEMnamecorrespondencetable. . 8Termdescription.........................8Structureofpages. . . . . . . . . . . . . . . . . . . . . . . 9Chapter 1Safety Precautions & Warnings   111.1 Symbolsrelatingtosafety . . . . . . . . . . . . 121.1.1 Safetyalertsymbol . . . . . . . . . . . . . . 121.1.2 Warningnotice(signalwords). . . . . . 121.1.3 Descriptionofgraphicsymbols. . . . . 121.2 Warninglabels. . . . . . . . . . . . . . . . . . . . . 131.2.1 AeroDRDetector. . . . . . . . . . . . . . . . 131.2.2 AeroDRBatteryCharger. . . . . . . . . . 141.2.3 AeroDRBatteryCharger2. . . . . . . . . 141.3 Safetyprecautions. . . . . . . . . . . . . . . . . . 151.3.1 Precautionsbeforeusage. . . . . . . . . 151.3.2 Precautionsforusage. . . . . . . . . . . . 151.3.3 Precautionsregardingelectromagneticwaves . . . . . . . . . . . 181.3.4 Precautionsregardingwirelesscommunication. . . . . . . . . . . . . . . . . . 231.3.5 Precautionsforinstalling,moving,andstoring.....................251.3.6 Precautionsregardingmaintenance. . 261.3.7 Precautionsonservicelife. . . . . . . . . 271.3.8 Pediatricpatients’use;. . . . . . . . . . . . 271.4R&TTEDECLARATIONofCONFORMITY. . 28Chapter 2Product Overview           312.1 Overviewofthisdevice..............322.1.1 Functions......................322.1.2 Systemcongurationandconnectionexamples . . . . . . . . . . . . 322.2 Componentnamesandfunctions. . . . . . 362.2.1 AeroDRDetector. . . . . . . . . . . . . . . . 362.2.2 AeroDRInterfaceUnit. . . . . . . . . . . . 372.2.3 AeroDRInterfaceUnit2. . . . . . . . . . . 382.2.4 AeroDRGeneratorInterfaceUnit....392.2.5 AeroDRBatteryCharger. . . . . . . . . . 402.2.6 AeroDRBatteryCharger2. . . . . . . . . 412.2.7 AccessPoint . . . . . . . . . . . . . . . . . . . 422.2.8 AeroDRI/FCable................432.2.9 AeroDRUFCable. . . . . . . . . . . . . . . 43
Contents45.2.3 AeroDRInterfaceUnit2. . . . . . . . . . . 785.2.4 AeroDRBatteryCharger. . . . . . . . . . 795.2.5 AeroDRBatteryCharger2. . . . . . . . . 795.2.6 AccessPoint . . . . . . . . . . . . . . . . . . . 795.2.7 Imageprocessingcontroller/Images. . 80Chapter 6Maintenance                816.1 Maintenanceandinspectionitems . . . . . 826.1.1 Maintenanceschedule. . . . . . . . . . . . 826.1.2 Cleaning.......................826.1.3 DisinfectionoftheAeroDRDetector. . 846.1.4 Consumables. . . . . . . . . . . . . . . . . . . 84Chapter 7Specications              857.1 Specications . . . . . . . . . . . . . . . . . . . . . 867.1.1 AeroDRDetector. . . . . . . . . . . . . . . . 867.1.2 AeroDRInterfaceUnit. . . . . . . . . . . . 897.1.3 AeroDRInterfaceUnit2. . . . . . . . . . . 897.1.4 AeroDRGeneratorInterfaceUnit....907.1.5 AeroDRBatteryCharger. . . . . . . . . . 907.1.6 AeroDRBatteryCharger2. . . . . . . . . 917.1.7 AccessPoint . . . . . . . . . . . . . . . . . . . 917.1.8 AeroDRI/FCable................927.1.9 AeroDRUFCable. . . . . . . . . . . . . . . 927.1.10 AeroDRXGCable. . . . . . . . . . . . . . . 927.1.11 AeroDRS-SRMCable. . . . . . . . . . . . 937.1.12 GeneralAeroDRSYSTEM. . . . . . . . . 93
5Introduction
6IntroductionDigitalradiographyAeroDRSYSTEM(hereafterreferredtoasthisdevice)performsX-rayimagingofthehumanbodyusinganX-rayplanardetectorthatoutputsadigitalsignal,whichistheninputintoanimageprocessingdevice,andtheimageacquiredwithadigitalimageacquisitiondeviceisthentransmittedtoalingsystem,printer,andimagedisplaydeviceasdiagnosticimagedata.• DiagnosticX-rayimagedataofthisdevicedoesnotprovidemammographicimages.• Thisdeviceisalsousedforcarryingoutexposuresonchildren.Thereare5typesofX-rayplanardetectorsforthisdevice:AeroDR1417HQ(AeroDRP-11),AeroDR1417S(AeroDRP-12),AeroDR1717HQ(AeroDRP-21),AeroDR1012HQ(AeroDRP-31)andAeroDRII1417HQ(AeroDRP-51),andconnectionismadebyeitherwirelessorwiredconnection.TheDIRECTDIGITIZERCS-7orImagePilot(hereafterreferredtoastheimageprocessingcontroller),whichcontrolsthereceiving,processing,andoutputofimagedataofthisdevice,isrequiredforoperation.Fortheoperationoftheim-ageprocessingcontroller,refertothe“OperationManual”oftheimageprocessingcontroller.Thisoperationmanualprovidesinstructionsonthebasicfunctionsforoperationofthisdevice.Thoseoperatingthisdeviceforthersttimeshouldreadthismanualbeforehand.Also,storethismanualclosetothisdeviceafterreadingitthrough,soitcanbeusedasaguidetoallowoptimumoperatingconditions.*If the pages of the operation manual are smudged and illegible, replace it with a new one (There is a feefor this service)* The illustrations in this manual use the AeroDRII 1417HQ (AeroDR P-51) and AeroDR Battery Charger asthe exampleIndications for UseTheAeroDRSYSTEMisindicatedforuseingeneratingradiographicimagesofhumananatomy.Itisintendedtore-placeradiographiclm/screensystemsingeneral-purposediagnosticprocedures.<OnlyforUSA>TheAeroDRSYSTEMwithP31isnotindicatedforuseinmammography,uoroscopy,tomographyandangiographyapplications. CAUTIONFederal law restricts this device to sale by or on the order of a phisitian
7IntroductionSummary of usability specications (for IEC/EN 60601-1-6, IEC/EN 62366)1) Medicalpurposes• Provisionandreadingofdiseaseandinjurydiagnosticimages.2) Patientgroups• Nopatientpopulationexistswhousesorisincontactwiththedevice.• PatientpopulationfortheX-rayimagesreadisnotspecied.3) Partsofbodyororganizationstowhichthedeviceismountedorthatinteractwiththedevice.• AeroDRDetectorcontactsthebodysurfaceofapatient.• AeroDRInterfaceUnit/AeroDRInterfaceUnit2contactsthebodysurfaceofanoperator.4) Operatingprinciple• AeroDRDetectorformsthestillimagesaccordingtotheX-rayenergypassingthroughthehumanandanimalbody;afterdigitizingtheexposedimage,itistransmittedtotheconsole(theimageprocessingcontroller)withwiredorwirelesscommunicationbywayofAeroDRInterfaceUnit/AeroDRInterfaceUnit2.• AeroDRInterfaceUnit/AeroDRInterfaceUnit2suppliesthepowertoanyofAeroDRDetector,AeroDRGenera-torInterfaceUnit,andAccessPoint(radiocommunicationdevice).• AeroDRGeneratorInterfaceUnitorAeroDRInterfaceUnit2interfaceswithanX-raydevice.• AccessPoint(radiocommunicationdevice)performsawirelesscommunicationwithAeroDRDetector.• Theconsole(theimageprocessingcontroller)processestheimagedataintothediagnosticimage,andthenstoresandoutputstheimagesaddedwiththepatientinformation.•TheAeroDRBatteryCharger/AeroDRBatteryCharger2chargestheAeroDRDetector.Itregisterstheusingcas-settewiththeexposureroom.5) Signicantphysicalcharacteristics• Referto"7.1Specications".6) Signicantperformancecharacteristics• Referto"2.1Overviewofthisdevice".7) Userofthisdevice• Nospecialtrainingisrequiredtousethisdevice.Theintendedusersofthisdeviceareasfollows.Aprofessionalingoodhealthwithspecialistknowledge/qualicationswhohasfullyunderstoodthecontentofthisdocument.(Suchasadoctororradiologicaltechnologist)Disclaimer(1)ThismanualmaynotbereproducedinwholeorinpartwithoutthepermissionofKonicaMinolta,Inc.(2)Thecontentsofthismanualmaybesubjecttochangewithoutpriornotice.(3)KonicaMinolta,Inc.isnotresponsibleforanyclaimsmadeformalfunctionordamagecausedbyinstallation,relocation,modification,maintenance,andrepairmadebyanyoneexceptKonicaMinoltaandcontractorsdesignatedbyKonicaMinolta.(4)KonicaMinolta,Inc.isnotresponsibleforanyclaimsmadeformalfunctionordamagetoKonicaMinoltaproducts,causedbythird-partyproductsnotinstalledbyKonicaMinolta.(5)KonicaMinolta,Inc.isnotresponsibleforanyclaimsmadeformalfunctionordamagecausedbymaintenanceorrepairusingmaintenancepartsotherthanthosespeciedbyKonicaMinolta.(6)KonicaMinolta,Inc.isnotresponsibleforanyclaimsmadeformalfunctionordamagecausedbynotobservingtheprecautionsandoperationmethodsdescribedintheoperationmanual.(7)KonicaMinolta,Inc.isnotresponsibleforanyclaimsmadeformalfunctionordamagecausedbytheenvironmentthatisnotsuitablefortheinstallationrequirementssuchaspowersourceandinstallationenvironmentdescribedintheInstallationRequirementoroperationmanual.(8)KonicaMinolta,Inc.isnotresponsibleforanyclaimsformalfunctionordamagecausedbyactsofnaturesuchasres,earthquakes,oods,orlightningstrikes.(9)KonicaMinolta,Inc.isnotresponsibleforanyclaimsformalfunctionordamagecausedbyusingthisdeviceforanypurposeotherthanthatspeciedforthisdevice.(10)Diagnosticandtreatmentactionisperformedundertheresponsibilityofthephysician(s).KonicaMinolta,Inc.isnotresponsibleforanydiagnostic/treatmentconditionsordiagnostic/treatmentresults.
8IntroductionTrademarkCompanynamesandproductnamesinthismanualaretrademarksorregisteredtrademarksoftheirrespectiveowners.Pleasenotethat©,®and™marksareomittedhereafter.Copyright©2014KonicaMinolta,Inc.AllRightsReserved.AeroDR SYSTEM name correspondence tableProduct name (Operation Manual name) Model name (nameplate name)AeroDRDetectorAeroDRP-11AeroDRP-12AeroDRP-21AeroDRP-31AeroDRP-51AeroDRInterfaceUnit AeroDRB-1AeroDRInterfaceUnit2 AeroDRInterfaceUnit2AeroDRGeneratorInterfaceUnit AeroDRX-1AeroDRBatteryCharger AeroDRD-1AeroDRBatteryCharger2 AeroDRBatteryCharger2Term descriptionThemeaningsoftermsusedinthisoperationmanualareasfollows:Terms ExplanationAeroDRDetector CollectivetermindicatingAeroDR1417HQ,AeroDR1417S,AeroDR1717HQ,AeroDR1012HQandAeroDRII1417HQ.Imageprocessingcontroller Theimageprocessingworkstation(CS-7orImagePilot)isreferredtoastheimageprocessingcontroller.Calibration ProcessingforcalibratingthecharacteristicsoftheAeroDRDetectorforeachpixel.PoE AnabbreviationforPoweroverEthernet.ProvidespowerusinganEthernetcable.Wiredcable CollectivetermindicatingAeroDRI/FCableandAeroDRUFCable.AeroSync ThisisamodeinwhichexposureisperformedwithoutbeingsynchronizedwiththeX-raydevice.
9IntroductionStructure of pages463.1 Startupandshutdown3.1.2 StartupofthisdeviceThe startup methods of this device are as follows.OAeroDRInterfaceUnit,AeroDRGeneratorInterfaceUnitandAccessPoint• The startup methods of the AeroDR Interface Unit, AeroDR Generator Interface Unit and Ac-cess Point are as follows.1 TurnthepowerswitchoftheAeroDRIn-terfaceUniton,andconrmthattheLED(green)lights.Power switchLED (green)2 WhenthepowerswitchoftheAeroDRInterfaceUnitisturnedon,powerisalsosuppliedtotheAeroDRGeneratorInter-faceUnit,andtheLED(green)willash.LED (green)HINT •••••••••••••••••••••••••••••••••••••• In Aero Sync mode, the AeroDR Generator Interface Unit is not used. •••••••••••••••••••••••••••••••••••••••••••••••••••••Normally, this device is used with the power on. When not used for more than 1 day, operate the start-up/shutdown as follows.Reference •••••••••••••••••••••••••••••••••••••• Refer to the "Operation Manual" of the image processing controller regarding on/off for the image processing controller. •••••••••••••••••••••••••••••••••••••••••••••••••••••3.1.1 StartupsequenceofthisdeviceThe startup sequence of this device is as follows.OWhenusingAeroDRInterfaceUnit1AeroDR Interface UnitAeroDR Generator Interface UnitAccess Point2Image processing controller3AeroDR Detector4AeroDR Battery Charger/AeroDR Battery Charger2Conrm that the AeroDR Detector is ready for use on the image processing controller.OWhenusingAeroDRInterfaceUnit21AeroDR Interface Unit2Access Point2Image processing controller3AeroDR Detector4AeroDR Battery Charger/AeroDR Battery Charger2Conrm that the AeroDR Detector is ready for use on the image processing controller.(1)(4)(2)(3)Number Item Description Icon(1) Itemheading Describesthetitlesofdescribedcontent. -(2) Operationprocedure Theoperatingprocedureisdescribedinsequentialnumericalsteps. -(3) Hint Describesimportantinformation. HINT(4) Reference Describesreferenceitems.Refertotheseasnecessary.Reference- Importantitems Describestheimportantitemsforoperation.Besuretoreadthem.IMPORTANT
10
11Chapter 1Safety Precautions & WarningsThischapterdescribesprecautionsandwarningstoensuresafeuseofthisdevice.
12111 Safety alert symbolThisisa"safetyalertsymbol".Thissymbolalertsyoutomattersand/oroperationpotentiallyhazardoustoyourselfandotherpeople.Readthesemessagesandfollowtheinstructionscarefully.112 Warning notice (signal words)Signalwordsindicatethedegreeofpotentialhazardsintheuseoftheproduct.Signalwordsincludethefollowingthreetypes,whichareusedaccordingtoriskofdamagecausedbydan-gerandtheseverityofdamage. DANGERIndicatesanimminentlyhazardoussituationwhich,ifnotavoided,willresultindeathorseriousinjury. WARNINGIndicatesapotentiallyhazardoussituationwhich,ifnotavoided,couldresultindeathorseriousinjury. CAUTIONIndicatesapotentiallyhazardoussituationwhich,ifnotavoided,couldresultinminorormoderateinjury.Itmayalsobeusedtoindicatehazardoussituationwhereonlyphysicaldamageislikelytooccur.113 Description of graphic symbolsIndicates the off position forthemainpowerswitchofthisdevice.Indicatestheonpositionforthemainpowerswitchofthisdevice.Indicatesthepositionwherethegroundisattached.IndicatesaB-typeAppliedPartsmedicaldevice.Indicatesthatfullcautionisrequiredwhenhandlingthisdevice.IndicatesthatitisnecessarytoreadtheUser'sManualbeforeuseoroperationofthisdevice.Indicates devices including radio fre-quencytransmitters.0197ItmeansconformitywiththeMedicalDe-vicesDirective93/42/EEC.0197isNotiedBodynumber.ItmeansconformitywiththeRadioEquipmentandTelecommunicationsTerminalEquipmentDirective1999/5/EC.Andthealertsign(!)meansthatiscategorizedClass2radioequipment.11 Symbols relating to safety
13Chapter 112 Warning labelsVariouswarninglabelsareattachedtothisdeviceonthelocationsshownbelow.Donotremovetheselabelsfromthisde-vice.Warninglabelsaretheretomakesurethattheuserrecognizespotentialhazardswhenoperatingthisdevice.* Ifawarninglabelistoodirtyordamagedtoread,contactKonicaMinoltatechnicalrepresentativestohaveanewwarninglabelattached,andredisplaybypartsreplacement.(Thereisafeeforthisservice.)121 AeroDR Detector
141.2Warninglabels122 AeroDR Battery Charger123 AeroDR Battery Charger2
15Chapter 1132 Precautions for usage WARNING• TheAeroDRDetectorisaprecisioninstrument.Ifitisdroppedorhitagainstanyobject,afailuremayoccurduetostrongimpactorexcessiveload.• Takenoteofthefollowingwhenusingthisdevice:–DonotsubjecttheAeroDRDetectortostrongshocksorexcessiveloadsbydroppingit,etc.– DonotexceedthespeciedoverallloadrangewhenapplyingaloadtoanAeroDRDetector.– Donotdisassembleormodifythisdevice.– Donotconnectanydevicesthatwerenotpur-chasedfromKonicaMinolta.– Donotturnthepowerswitchofforpulloutthepowercablewhilethesystemisoperating.– BecarefulnottodroptheAeroDRDetectoronanypartofaperson'sbodybycatchingtheAeroDRI/FCableorAeroDRUFCableonyourfeet.– DonotleanonorputpressureontheAeroDRBatteryChargerinstalledonawall.• TheAeroDRI/FCableandAeroDRUFCableareconnectedtotheAeroDRDetectorusingmagneticforce.WhenmovingtheAeroDRDetector,donotholdontothecable,andalwaysholdontheAeroDRDetector.Also,donotgraspandpulltheAeroDRDetectorforcefully.13 Safety precautionsReadallsafetyprecautionsthoroughlybeforeusingthisdevice.Besuretoobservethesafetyprecautionsdescribedinthissection.131 Precautions before usage CAUTION• Theoperators(hospitalsandclinics)holdresponsi-bilityfortheusageandmaintenanceofthisdevice.Donotusethisdeviceunlessyouareaphysicianorcertiedpersonunderlaw.• Thisdeviceexcludingtheimageprocessingcon-trollerissuitableforuseinthepatientenvironment.(PCusedfortheimageprocessingcontrollerisnotsuitableforuseinthepatientenvironment.)• Confirmthatthisdeviceisoperatingnormallybe-foreusing.• Whenaproblemoccurswiththisdevice,turnthepoweroff,attachanappropriatesign,suchas"malfunction",onthisdevice,andcontactKonicaMinoltatechnicalrepresentatives.• Thisdeviceisnotexplosion-proof,sodonotuseanyammableorexplosivegasnearthisdevice.• Forthebasicoperationofthecomputer,displaymonitor,andoptionalpartsforthisdevice,refertotheiroperationmanuals.• Pleasefollowtherulesandregulationsofyourrel-evantauthoritiesinthedisposalofthisproduct,ac-cessories,options,consumables,mediaandtheirpackingmaterials.For EU member states only Thissymbolmeans:Donotdisposeofthisproducttogetherwithyourhouseholdwaste!Pleaserefertotheinformationofyourlocalcommunityorcontactourdealersregardingtheproperhandlingofend-of-lifeelectricandelectronicequipments.Recyclingofthisproductwillhelptoconservenaturalresourcesandpreventpotentialnegativeconsequencesfortheenvironmentandhumanhealthcausedbyinappropriatewastehandling.
1.3Safetyprecautions16 WARNING• Ifthereisanysmoke,odor,orabnormalsound,itmaycauseareifuseiscontinued,soimmediatelyturnthepowerswitchoff,unplugthepowerplugfromthewalloutlet,andcontactKonicaMinoltatechnicalrepresentatives.• Takenoteofthefollowingtoreducetheriskofre,electricshock,orelectricalleakage:– Usespeciedcablesforthepowercable,etc.– Useawalloutletwiththecorrectratingasapowersource.– Connectthepowerplugtothewalloutletprop-erlywithoutanyslack.– Useagroundedpowersource.– Ifyoudonotplantousethisdeviceforanex-tendedperiodoftime,unplugthepowerplug.– Thesuppliedpowercableisdedicatedforthisdevice,sodonotuseitelsewhere.– Avoidexposuretoliquidsuchaswater.– Makesurethatforeignmaterial,suchaspiecesofmetalorwire,doesnotgetinside.– DonotallowanymetalorconductiveobjectstocomeintocontactwiththespringconnectoroftheAeroDRI/FCable,AeroDRUFCableorAeroDRBatteryCharger2.– Donothandlethepowerplugwithwethands.–Donotletsoilordustaccumulateonthepowerplug,AeroDRI/FCable,AeroDR UFCableorAeroDRBatteryCharger2.– Donotuseextensioncords.– Donotconnectmanyplugstoasingleelectricaloutlet.– Donotdamagethepowercable,AeroDRI/FCable,orAeroDRUFCable.Also,donotusedamagedcables.– Donotblocktheventilationopenings.• Ifthereisanyabnormalityinappearancesuchasdeformationofthehousingoracrack,stopusingthedeviceimmediatelyandcontactKonicaMinoltatechnicalrepresentatives. CAUTION• Takenoteofthefollowingwhenusingthisdevice:– Donotusedevicesthatemitelectromagneticwavessuchashigh-frequencytherapyequip-ment,mobilephones,orpocketpagers,closetothisdevice.– TakenoteofthereceptionstatusforradiosandTVsnearthisdevice,sinceinterferencemayoc-curinthemwhenthisdeviceisinuse.– Useunderthespecifiedenvironmentalcondi-tions.Failuretodosomayresultindegradationofperformanceormalfunction.– Limitcontinuoususeinahotandhumidenviron-ment(35to37°C/95%orlower)ofanincubatortowithin25minutes.– DonotinserttheAeroDR1012HQintotheAero-DRBatteryChargerbecausethechargercannotbeusedforregistrationorchargingthebattery. CAUTION• TakethefollowingnoteswhenusingtheAeroDRDetector:– UsetheAeroDRDetectoronaatbase.IftheAeroDRDetectorisplacedonaslopingsurfaceandsubjectedtoaload,itsinternalsensormaybedamaged.– WhenlayingthepatientontotheAeroDRDetec-torduringpositioning,dosoveryslowly.– WhenplacingtheAeroDRDetectorunderthepatientaspartoftheexposureprocess,insertandpulloutthedetectorslowly.– Usetherecommendedadapterwhenyouneedtoperformexposureonastretcheroraplacewhereloadistobeappliedlocally.
1.3Safetyprecautions17Chapter 1 CAUTION– TheAeroDRDetectorisnotwaterproof.Ifitisexposedtoorimmersedinpatients'bodyuids,chemicals,water,orotherliquids,suchliquidsmayentertheinstrumentthroughexteriorgaps,causingafailure.BesuretouseavinylsheetorothermaterialtocoverorwraptheAeroDRDetectorwhenitispossiblethattheAeroDRDe-tectormaybeexposedtopatients'bodyfluids,chemicals,water,orotherliquids.– NeverleaveAeroDRDetectorsinhotandhumidenvironmentsforlongperiodsoftime.– TheAeroDRDetectorhaswirelessantennaepo-sitionedat2places.Donotblockthemwiththebodyormetalbecausethatwillinterferewith,dis-connectorslowdownwirelesscommunication.– PressingthepowerswitchcauseseachLED(green,orange,blue)tolighttemporarilyorash.Afterthis,onlygreenbeginstoashinaslowcycle.Pleasecheckthelightingorashingofeachcoloronce.– ThebatterycapacityisdesignedtoallowthelifeperiodcalculatedbasedonthestandardusageoftheAeroDRDetector.Itcanbereplacedwithanewbatteryforafeeifreplacementisneces-saryafterthewarrantyperiodduetobatterybreakdownordecreaseincapacity.– CheckthatthebuzzersoundswhentheAeroDRDetectorisinsertedintotheAeroDRBatteryCharger/AeroDRBatteryCharger2.Also,checkthattheLEDisinthechargestatus.– BecarefulnottogetyourhandcaughtwhensettingtheAeroDRDetectorintotheAeroDRBatteryCharger/AeroDRBatteryCharger2. CAUTION– IftheAeroDRDetectorisinsertedintotheAero-DRBatteryCharger/AeroDRBatteryCharger2,makesurethattheAeroDRBatteryCharger/AeroDRBatteryCharger2willnottipoverduetoanyshockappliedtotheAeroDRDetector.– TheAeroDRDetectorisprecisionequipment,andthereforeimpactorvibrationduringradiog-raphyorimagetransfermayaffecttheimagequality.BecarefulwhenhandlingtheAeroDRDetectorduringandjustafterradiography.–NeverleaveAeroDRDetectorsaroundheatgenera-torssuchaselectriccarpet.–DonotdamageordeformtheAeroDRDetector;doingsomayhaveaneffectonexposedimages,orleadtoinjury.• WhenusingtheAeroDRI/FCableorAeroDRUFCable,observethefollowing:– Removethecablebyholdingtheconnectorhousing.– Donotletthecablegetpinchedbydoorsanddonotplaceheavyobjectsonit.– Donotbendorpullthecableexcessively.– MakesurethatthecableisproperlyconnectedtotheAeroDRDetectorwithoutwobbling.– Donotconnecttheconnectorhousingback-wards.• DonotsitonorputyourfeetontheAeroDRBat-teryCharger/AeroDRBatteryCharger2.
1.3Safetyprecautions18 CAUTION• TakenoteofthefollowingiftheAeroDRDetectorisdamagedanduorescentmediumorleadisex-posed:– Immediatelystopusingthedevice,andcontactKonicaMinoltatechnicalrepresentatives.– Iftheuorescentmediumgetsinyoureyes,donotrubandinsteadwashwithrunningwaterim-mediately.– Ifyouhaveswallowedanyofthefluorescentmediumoriftheuorescentmediumhasgottenintoyoureyes,administerrst-aidtreatmentim-mediately,andconsultadoctor.– Ifthemediumcomesintocontactwithyourskindirectly,washtheaffectedareathoroughlywithwater.– Useandstoreinalocationinaccessibletochil-dren.• WhentheAeroDRDetectorisusedforexposure,payattentiontothefollowingitems.– Startexposureafterconrmingonthedisplayoftheimageprocessingcontrollerthatthemachineisreadyforexposure.– PerformexposureundertheX-rayimagingcon-ditionsthathasbeenconrmedbyus.– Usethespeciedgridtoperformexposure.– Applythespecifiedoperationmethodstousethegrid.– DonotlettheAeroDRDetectorvibrateorre-ceiveshockuntilthepreviewimageisdisplayed.• PrecautionswhenperformingexposureinAeroSyncmode.– Conrmthattheimageprocessingcontrollerisreadyforexposurethroughitsdisplaybeforeperformingexposure.– Conrmthataconrmationissoundedfromtheimageprocessingcontrollerafterthestartofex-posure.– DonotlettheAeroDRDetectorvibrateorre-ceiveshockuntilthepreviewimageisdisplayed.– ConrmthattheAeroDRDetector'sbatterylevelisfullbeforeperformingexposure.– Usethesystemundertheexposureconditionconrmedpriortoexposure.• Whensettingthemaximumexposuretimeto4.0,6.7,10.3,besuretocontactKonicaMinoltatechni-calrepresentatives.133 Precautions regarding electromagnetic waves EMC StatementThisdevicehasbeentestedandfoundtocomplywiththelimitsformedicaldevicesinIEC60601-1-2:2007.Theselimitsaredesignedtoprovidereasonablepro-tectionagainstharmfulinterferenceinatypicalmedi-calinstallation.Thedevicegenerates,usesandcanradiateradiofrequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions,maycauseharmfulinterferencetootherdevicesinits vicinity.However,thereisnoguaranteethatinterferencewillnotoccurinaparticularinstallation.Whetherthisdevicedoescauseharmfulinterferencetootherdevicescanbedeterminedbyturningthisde-viceoffandon.Ifitcausesharmfulinterference,theuserisencouragedtotrytocorrecttheinterferenceby1ormoreofthefollowingmeasures:• Reorientorrelocatethereceivingdevice.• Increasetheseparationbetweenthedevices.• Connectthisdeviceintoawalloutletonacircuitdiffer-entfromthattowhichtheotherdevicesareconnected.• ContactKonicaMinoltatechnicalrepresentatives.
1.3Safetyprecautions19Chapter 1 Supplementary information regarding IEC 60601-1-2: 2007(1)Takeprecautionsagainstthisdeviceespeciallyre-gardingEMC.Installandputintoserviceaccordingtotheelectromagneticcompatibility(EMC)informa-tionprovidedinthemanual(Table1-Table4).(2) Donotusemobilephonesorpocketpagersinthevicin-ityofthisdevice.Useofmobilephonesorpocketpag-ersnearthisdevicecancauseerrorsinoperationduetoelectromagneticwaveinterference,sosuchdevicesshouldbeturnedoffinthevicinityofthisdevice.(3)Cablelist• Powercable(3.048m/3-Wire/NoShielding)• Ethernetcable(max100m/100BASE-TX)• Ethernetcable(PoE)(30m/NoShielding)• VariousAeroDRI/FCables• VariousAeroDRUFCables• AeroDRCollimatorCableSet• VariousAeroDRXGCableSets(4)Theuseofaccessories,transducersandcablesotherthanthosesoldbyKonicaMinolta,Inc.asinternalcomponents,mayresultinincreasedemis-sionsordecreasedelectromagneticimmunityofthisdevice.(5)Donotusethisdeviceadjacenttoorstackedwithotherdevices.Ifadjacentorstackeduseisneces-sary,conrmnormaloperationinthecongurationinwhichthisdevicewillbeused.(6)SpecicationsregardingRFtransmittersfrequency:• Frequency:2412to2472MHz5180to5320MHz,5500to5825MHz• Modulation:2412to2472MHz:DSSS/CCK/OFDM5180to5320MHz,5500to5825MHz:OFDM• Maximumeffectiveradiationpower:+10dBm• Thisdevicemaybeinterferedwithbyotherdevic-esthatconformtoCISPRemissionrequirements.
201.3SafetyprecautionsTable 1Guidelines and manufacture's declaration - electromagnetic emissionsThisdeviceisintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerortheuserofthisdeviceshouldassurethatitisusedinsuchanenvironment.Emissions test Compliance Electromagnetic environment - guidelinesRFemissionsCISPR11 Group1ThedeviceusesRFenergyonlyforitsinternalfunction.Therefore,itsRFemissionsareverylowandarenotlikelytocauseanyinterferenceinnearbyelectronicequipment.RFemissionsCISPR11 ClassBThisdeviceissuitableforuseinallestablishmentsincludingthefollowing:Domesticestablishmentsandthosedirectlyconnectedtothepubliclow-voltagepowersupplynetworkthatsuppliesbuildingsfordomesticpurposes.HarmonicemissionsIEC61000-3-2 ClassAVoltageuctuations/ickeremissionsIEC61000-3-3CompliesTable 2Guidelines and manufacturer's declaration - electromagnetic immunityThisdeviceisintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerortheuserofthisdeviceshouldassurethatitisusedinsuchanenvironment.Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidelinesElectrostaticdischarge(ESD)IEC61000-4-2±6kVcontact ±6kVcontact Floorsshouldbewood,concreteorceramictile.Ifoorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.Mainspowerqualityshouldbethatofatypicalcom-mercialorhospitalenvironment.±8kVair ±8kVairElectricalfasttransient/burstIEC61000-4-4±2kVforpowersupplylines±2kVforpowersupplylines±1kVforinput/outputlines±1kVforinput/outputlinesSurgeIEC61000-4-5±1kVdifferentialmode ±1kVdifferentialmode Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenviron-ment.±2kVcommonmode ±2kVcommonmodeVoltagedips,shortinterruptionsandvoltagevariationsonpowersupplyinputlinesIEC61000-4-11<5%UT(>95%dipinUT)for0.5cycle<5%UT(>95%dipinUT)for0.5cycle Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenviron-ment.Iftheuserofthedevicerequirescontinuedoperationduringpowermainsinterruptions,itisrecommendedthatthedevicebepoweredfromanuninterruptedpowersupplyorabattery.40%UT(60%dipinUT)for5cycles40%UT(60%dipinUT)for5cycles70%UT(30%dipinUT)for25cycles70%UT(30%dipinUT)for25cycles<5%UT(<95%dipinUT)for5sec<5%UT(<95%dipinUT)for5secPowerfrequency(50/60Hz)magneticeldIEC61000-4-83A/m 3A/mPowerfrequencymagneticeldsshouldbeatlevelscharacteristicofatypicallo-cationinatypicalcommercialorhospitalenvironment.[NOTE]UTistheACmainsvoltagepriortoapplicationofthetestlevel.
21Chapter 11.3SafetyprecautionsTable 3Guidelines and manufacturer's declaration - electromagnetic immunityThisdeviceisintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerortheuserofthisdeviceshouldassurethatitisusedinsuchanenvironment.Immunity test IEC 60601 test levelCompliance level Electromagnetic environment - guidelinesConductedRFIEC61000-4-6RadiatedRFIEC61000-4-33Vrms150kHzto80MHz3V/m80MHzto2.5GHz[3]V[3]V/mPortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartofthisdevice,includ-ingcables,thantherecommendedseparationdistancecalculatedfromtheequationapplicabletothefrequencyofthetransmitter.Recommendedseparationdistanced=[1.2]√Pd=[1.2]√P80MHzto800MHzd=[2.3]√P800MHzto2.5GHzwherePisthemaximumoutputpowerratingofthetrans-mitterinwatts(W)accordingtothetransmittermanufac-tureranddistherecommendedseparationdistanceinmeters(m).FieldstrengthsfromxedRFtransmitters,asdeterminedbyanelectromagneticsitesurveya,shouldbelessthanthecompliancelevelineachfrequencyrangeb.Interferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:[NOTE] At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.[NOTE] Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreectionfromstructures,objectsandpeople.a Fieldstrengthsfromxed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xedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredeldstrengthinthelocationinwhichthisdeviceisusedexceedstheapplicableRFcom-pliancelevelabove,thisdeviceshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingthisdevice.b Overthefrequencyrange150kHzto80MHz,eldstrengthshouldbelessthan[3]V/m.
221.3SafetyprecautionsTable 4Recommended separation distance between portable and mobile RF communications equipment and the deviceThisdeviceisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomerortheuserofthisdevicecanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andthisdeviceasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.Rated maximum output power of the transmitterWSeparation distance according to frequency of transmitterm150 kHz to 80 MHzd=[12] √P80 MHz to 800 MHzd=[12] √P800 MHz to 25 GHzd=[23] √P0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 8100 12 12 23For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frequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.[NOTE] At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.[NOTE] Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreectionfromstructures,objectsandpeople.
1.3Safetyprecautions23Chapter 1134 Precautions regarding wireless communication CAUTION• Thisdeviceisequippedwithacommunicationfunc-tionthatoperatesviawirelessLAN.Conformanceisrequiredwiththerelevantregulationsdenedbythecountriesinwhichthisdeviceistobeused.• Inappropriateusagemaycauseinterferenceinra-diocommunication.Also,ifthisdeviceismodied,approvalandwarrantyaccordingtotheradiolawoftheapplicablegovernmentwillbevoided.• Itmayaffectaeronauticalsystems,sodonotuseon-boardairplanes.• Thisdevicemaybeaffectedbyotherwirelessde-vices.Makesurethattheenvironmentisfreeofwirelesscommunications.• AeroDRDetectorhasbeenconfirmedtocomplywiththerelevantregulationsofthefollowingcoun-tries:United States & CanadaFederal Communications Commission Statement / Canadian Department of Com-munications•AeroDR Detector complies with Part 15 of FCC Rules and Industry Canada license-exempt RSS standard(s).Operationis subjectto the following 2 conditions:(1) this devicemay not cause interference, and (2) thisdevicemustacceptanyinterference, includinginterference that may cause undesiredoperationofthisdevice.•This transmitter must not be co-located oroperated in conjunction with any other an-tennaortransmitter.•5.15-5.35GHzband isrestrictedtoindooroperationsonly.•Theavailablescientificevidencedoesnot showthat any health problems are associated withusinglowpowerwirelessdevices. There isnoproof, however, that these low power wirelessdevices are absolutely safe. Low powerWireless devices emit low levels of radiofrequencyenergy(RF)inthemicro-wave rangewhile being used. Whereas high levels of RFcanproducehealtheffects(by heating tissue),exposureoflow-levelRFthat doesnot produceheating effects causes no known adversehealth effects. Many studies of low-level RFexposures have not found any biologicaleffects. Some studies have suggested thatsome biological effects might occur, but suchfindingshavenotbeencon-firmedbyadditionalresearch. AeroDR Detec-tor has been testedand found to comply with FCC/IC radiationexposure limits set forth for a controlledequipmentandmeetstheFCC radio frequency(RF)ExposureGuidelines and RSS-102ofthe ICradiofrequency(RF) Exposurerules.• CompliancewithFCCrequirement15.407(c):Datatransmissionisalwaysinitiatedbysoft-ware,whichisthepasseddownthroughtheMAC,throughthedigitalandanalogbase-band,andnallytotheRFchip.SeveralspecialpacketsareinitiatedbytheMAC.ThesearetheonlywaysthedigitalbasebandportionwillturnontheRFtransmit-ter,whichitthenturnsoffattheendofthepacket.Therefore,thetransmitterwillbeononlywhileoneoftheaforementionedpacketsisbeingtransmitted.Inotherwords,thisde-viceautomaticallydiscontinuetransmissionincaseofeitherabsenceofinformationtotransmitoroperationalfailure.• CompliancewithFCCrequirement15.407(g):FrequencyTolerance:20ppmFCC WARNINGChangesormodicationsnotexpresslyapprovedbythepartyresponsibleforcompliancecouldvoidtheuser'sauthoritytooperatetheequipment.European UnionEuropean Union Directives Conformance StatementAeroDRDetectorconformswiththeDeclara-tionofConformity(DoC)toDirective1999/5/EC(toR&TTEDirective).Thisdevicepur-poselyconnectstoanaccesspointofa5GHznetwork.AeroDRDetectorisusedforthefollowingcoun-triesindicatedbycountrycode(ISO31662-lettercode).AT BE BG CY CZ DKEE FI FR DE GR HUIE IT LV LT LU MTNL PL PT RO SK SIES SE GB IS LI NOCH•High-power radars are allocated as primaryusers (i.e. priority users) of the bands5250-5350 MHz and 5650-5850 MHz andthat these radars could cause interferenceand/or damage to LE-LAN devices.
1.3Safetyprecautions24TaiwanObserve the following based on the regula-tions stated in Article 10 of Administration Measures for Low-power Radiation Electric MachinesArticle12Asfortype-approvalqualiedlow-powerradio-frequencygenerator,nocompany,rm,orusermayarbitrarilychangethefrequency,increasethepoweroralterthefunctionorcharacteristicsoftheoriginaldesignwithoutpriorpermission.Article14Theuseoflow-powerradio-frequencyelectricmachinesshallnotaffectairflightsafetyordisturblawfulcommunication.Ifdisturbanceisfound,theuseofsuchelectricmachinesshallbesuspendedimmediatelyandsuchuseshallnotberesumeduntilthedisturbanceiseliminated.Lawfulcommunicationmentionedinthepre-cedingparagraphreferstowirelesscommuni-cationoperationinaccordancewiththeprovi-sionsoftheTelecommunicationLaw.Low-powerradio-frequencyelectricmachinesshalltoleratedisturbancefromlawfulcommu-nicationorfromradio-waveradiationelectricmachineforindustrial,scienticormedicaluse.China1. Clearlyindicatethetechnicalindicatorsandthescopeofusageintheaccompanyingdoc-ument,andexplaintheusageofallcontrols,adjustments,andswitches,etc.Operatingfrequencyrange:5725-5850MHzTransmitpower:≤500mWand≤27dBmEquivalentisotropicradiatedpower(EIRP):≤2Wand≤33dBmMaximumradiationpowerdensity:≤13dBm/MHzand≤19dBm/MHz(EIRP)FrequencyTolerancelimit:20ppmTransmitpoweratthebandedge(EIRP):≤80dBm/Hz(≤5725MHzor≥5850MHz)Spuriousemissions:≤-36dBm/100kHz(30-1000MHz)≤-40dBm/1MHz(2400-2483.5MHz)≤-40dBm/1MHz(3400-3530MHz)≤-33dBm/100kHz(5725-5850MHz)(Note:Otherthan±2.5-timessupportedchannelbandwidth)≤-30dBm/1MHz(Other1-40GHz)2. Donotarbitrarilychangefrequencyorin-creasetransmitpower(includingtheaddedradiofrequencyamplifier).Inaddition,donotmountanantennawithoutpermission,orchangetoanothertransmissionantenna.3.Wheninuse,donotcauseharmfulinterferenceinotherlegalwirelesscommunicationservices.Ifyoufindinterferencetobeoccurring,discontinueuseimmediately.Aftertakingmeasurestoeliminatein-terference,youmaycontinueusingthedevice.4.Ifyouuselowpowerradioequipment,youmustacceptinterferencefromvariouswirelessser-vicesorradiationinterferencefromindustrial,scienticandmedicalapplicationequipment.5. Donotusenearaplaneoranairport.
1.3Safetyprecautions25Chapter 1South KoreaBecausethiswirelessequipmentmaybeaf-fectedbyradiointerference,itcannotprovideservicesrelatedwithlifesafety.ThailandAeroDRDetectorconformstoNTCtechnicalrequirement.BrazilThisequipmentoperatessecondarily,thatis,itdoesn'tbenefitfromprotectionagainstharm-fulinterference,evenfromstationsofthesametype,andcannotcauseinterferencetosystemsthatoperateprimarily.AeroDRDetectorhasbeenapprovedbyANA-TELincompliancewiththeproceduresregu-latedbyResolution242/2000andcomplieswiththeapplicabletechnicalrequirements.Formoreinformation,pleasevisit:http://wwwanatelgovbrMexicoThisequipmentoperatesonasecondaryba-sis;consequently,youmustacceptharmfulin-terferencesfromequipmentofthesametype,andcannotcauseinterferencestosystemsoperatingonaprimarybasis.135 Precautions for install-ing, moving, and storing WARNING• TakenoteofthefollowingwhenmovingthisdevicenotincludingtheAeroDRDetector:– Donotsubjecttoshocksorvibration.– Donotstartmovinguntilthepoweristurnedoff,andoperationhasstoppedcompletely.– Donotmovewiththepowercableoranyothercableconnected.• WheninstallingtheAeroDRBatteryCharger/AeroDRBatteryCharger2onatabletop,observethefollowing:– InstallonabasethatcanwithstandmaximumpatientweightbecauseloadisinsertedwhensettingtheAeroDRDetector.– ThecontactareafortheAeroDRBatteryCharger/AeroDRBatteryCharger2mustbelargerthantheareaoftheAeroDRBatteryChargersothatitwillnotfalldownwhentheAeroDRDetectorissetorwhenpeopletouchitbyaccident.– Installonahorizontalandstablesurface.– Donotuseabasethathasasurfacemadeofslipperymaterialsuchasteon.–Connectpowercableandwiressothatnoonewilltrip.–InstallinaplaceeasytosettheAeroDRDetector.–InstallsothattheventonthebacksideoftheAeroDRBatteryCharger2isnotblocked. CAUTION• BecauseconnectionsoftheX-raydevicecanonlybemadebyKonicaMinoltaoritsdesignatedcontractors,contactKonicaMinoltaoritsdesignatedcontractors.• ContactKonicaMinoltaordealersspecifiedbyKonicaMinoltatoinstallormovethisdevice.• FortheX-raydevicesenabledtoconnect,contactKonicaMinoltatechnicalrepresentatives.• Sinceitisrequiredtomeetthespecificationpro-videdbytheX-raydevicemanufacturertoconnectwithanX-raydevice,contactKonicaMinoltaordealersspeciedbyKonicaMinolta.• Takenoteofthefollowingwheninstallingorstoringthisdevice.– Donotinstallorstoreinalocationwhereitmaybeadverselyaffectedbyatmosphericpressure,temperature,humidity,ventilation,sunlight,dust,salt-air,oraircontainingsulfur.–Donotinstallorstoreinalocationwhereitisnotstable,ventilationisinsufficient,thedifferenceinlight-darkisgreat,electromagneticwavesaregenerated,orwheresubjecttovibrationorshock.– Donotinstallorstoreinalocationwherechemi-calagentsareusedorstored.–Donotinstallthisdevicefacinguporupsidedown.– DonotinstalltheAeroDRInterfaceUnit,AeroDRInterfaceUnit2andAeroDRGeneratorInterfaceUnitstackedoneachother.
1.3Safetyprecautions26 CAUTION• ConnecttheAeroDRInterfaceUnit2/AeroDRGen-eratorInterfaceUnittoanX-raydevicethatcon-formstoIEC60601ortoanequivalentstandard.• Donotuseaccesspointsotherthanthoseonthisdevice.136 Precautions regarding maintenance WARNING• Performthemaintenanceandinspectionperiodi-cally.Inadditiontotheuserperiodicalmaintenancethatneedstobeperformed,periodicalmaintenancebyaserviceengineerisalsorequired.• Iftherearestainssuchasbodyfluids,cleananddisinfect. CAUTION• Basedonthewarranty,partsthatarenolongerun-derwarranty(1year)canbereplacedforafee.• Turnoffthepoweranddisconnectthepowerplugfromthewalloutletbeforecleaningormaintainingthisdevice.• Securelyconnectthepowercable,AeroDRI/FCable,andAeroDRUFCableaftercleaningandmaintenance.• Cleanthedirtfrombetweentheprotectivecoverandtheexterior,andtheterminalusingacommer-cialplasticbrush.Donotcleanwithsharporhardobjects.• TakecareregardingthefollowingwhendisinfectingtheAeroDRDetector.– Useethanolfordisinfection,isopropanolfordisinfection,orcommercialchlorinebleach,or0.5%hypochlorite(10-folddilutionofhouseholdbleach)whendisinfecting.However,bleachandhypochloritearecorrosive,sowashthebleachoffwelltoavoidcorrosion. CAUTION– IfyoudirectlyapplyorspraydisinfectingsolutionontheAeroDRDetector,thesolutionwillentertheinstrumentthroughexteriorgaps,causingafailure.Dampenalint-free,softclothwithdisin-fectingsolution,anduseafterwringingitthor-oughly.DonotapplydisinfectingsolutionontothewiredconnectionconnectorandLEDwhencleaning.– Disinfectingsolutionisachemicalagent,sofol-lowtheprecautionsofthemanufacturer.• FullychargebatteryonceamontheveniftheAero-DRDetectorhasnotbeenusedforalongtime.
1.3Safetyprecautions27Chapter 1137 Precautions on service life CAUTIONService lifeName Service lifeAeroDRDetector 6yearsAeroDRInterfaceUnit 6yearsAeroDRInterfaceUnit2 6yearsAeroDRGeneratorInterfaceUnit 6yearsAeroDRBatteryCharger 6yearsAeroDRBatteryCharger2 6yearsAeroDRI/FCable 6yearsAeroDRUFCable 6years• Theaboveservicelifeisvalidonlyiftheproducthasbeenproperlyoperatedwhilefollowingtheprecautionsforuseandperformingthespeciedmaintenance.(Byselfcertication<ourdata>)• Theservicelifemaydifferdependingonusageconditionsandenvironment.• Somecomponentpartsofthisdevicearecom-merciallyavailablepartsthathaveashortcycleofmodelchanges,therefore,itmightnotbepossibletosupplyservicepartsevenwithintheservicelife.Inaddition,relatedcomponentpartsmayneedtobereplacedtomaintaincompatibil-ityatthetimeofmodelchange.138 Pediatric patients’ use;AeroDRSystemwithP-31doesnothaveanX-raygeneratingfunction,anddoesnotcontrolX-raygen-eratorunit.AeroDRSystemwithP-31isusedconnectingwithX-raygeneratorunitcurrentlyusedlegallyintheUnitedStatesofAmerica.IncaseofusingAeroDRSystemwithP-31forpediat-ricpatients,pleasemanageappropriatelyaspediatricpatientsreceivetheminimumnecessaryamountofX-rayradiationforproducingdiagnosticqualityimages.WhenusingAeroDRSystemwithP-31forthepediatricpatients,pleaseconnectonlywithanX-raygeneratorunitwhichhastheradiationmanagementfunctionforthepediatricpatients,andfollowtheinstructionofX-raygeneratorunitforthepediatricpatients.Forfurtherassistanceforthepediatricpopulationin-cludesneonates,pleaserefertothefollowingHomePages.TheImageGentlyBacktoBasicscampaignmaterials;(http://www.pedrad.org/associations/5364/ig/?page=824)FDA'sPediatricX-rayImagingwebpage;(http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm)
2814 R&TTE DECLARATION of CONFORMITY
29Chapter 11.4R&TTEDECLARATIONofCONFORMITY
30
31Chapter 2Product OverviewThischapterdescribestheoverviewofthisdevice.
3221 Overview of this deviceThissectiondescribesthefunctionsofthisdeviceaswellasasystemcongurationandconnectionexamplesusingthisdevice.211 FunctionsThisdeviceconsistsofAeroDRDetector,AeroDRInterfaceUnit/AeroDRInterfaceUnit2,AeroDRGeneratorInterfaceUnit,AeroDRBatteryCharger/AeroDRBatteryCharger2,AccessPoint,etc.WiththeAeroDRDetector,diagnosticX-raydigitalimagedataisgeneratedbytheirradiationsignalandexposurefromanX-raydevice,andsenttotheim-ageprocessingcontroller.Furthermore,theAeroDRDetectorcanbeconnectedwith(orinsertedin)anAeroDRInterfaceUnit/AeroDRInterfaceUnit2orAeroDRBatteryCharger/AeroDRBatteryCharger2orremovedfromthem.212 System conguration and connection examples Thesystemcongurationandconnectionexamplesareasfollows. Basic conguration example Number Name Functions(1) AeroDRDetector• Thereare4typesofAeroDRDetectors:AeroDR1417HQ,AeroDR1417S,AeroDR1717HQ,AeroDR1012HQandAeroDRII1417HQ.• AeroDRDetectorisofB-typeAppliedParts.(2) AeroDRInterfaceUnit• SuppliespowertotheAeroDRGeneratorInterfaceunitandtheAccessPoint,andsuppliespowertotheAeroDRDetectorandchargesthebatteryoftheAeroDRDetectorwhenanAeroDRI/FCableorAeroDRUFCableisused.• 4AeroDRDetectorscanbeconnectedviawirelessconnectionand2viawiredconnection.• TheexpansionAeroDRInterfaceUnitisrequiredforconnectingthethirdandfourthAeroDRDetectorsviawiredconnection.(3)AeroDRInterfaceUnit2• SuppliespowertotheAccessPoint,andsuppliespowertotheAeroDRDetec-torandchargesthebatteryoftheAeroDRDetectorwhenanAeroDRI/FCableorAeroDRUFCableisused.• 4AeroDRDetectorscanbeconnectedviawirelessconnectionand2viawiredcon-nection.• TheexpansionAeroDRInterfaceUnitisrequiredforconnectingthethirdandfourthAeroDRDetectorsviawiredconnection.• RelayssignalsbetweentheX-raydevice,theAeroDRDetector,andtheimageprocessingcontroller.(4)AeroDRGeneratorInterfaceUnit*1RelayssignalsbetweentheX-raydevice,theAeroDRDetector,andtheimageprocessingcontroller.(5) AeroDRBatteryCharger*1ChargestheAeroDRDetector.ItalsohastheregistrationfunctionfortheAeroDRDetector.• TheAeroDR1012HQcannotbechargedandregisteredusingtheAeroDRBatteryCharger.(6) AeroDRBatteryCharger2*1ChargestheAeroDRDetector.ItalsohastheregistrationfunctionfortheAeroDRDetector.(7) AccessPoint*1UsedforwirelessconnectionwiththeAeroDRDetector.*2(8) AeroDRI/FCableUsedforwiredconnectionwiththeAeroDRDetector.AlsousedforchargingandregisteringtheAeroDRDetector.(9) AeroDRUFCable*1UsedwhentheAeroDRDetectorissetinthewallstandortable.(10) Imageprocessingcontroller Controlsthereception,management,andoutputofthisdevice'simagedata.(11) AeroDRXGCable*1PerformssignalrelaybetweentheX-raydeviceandtheAeroDRGeneratorInterfaceUnit.(12) AeroDRCollimatorCable*1PerformsexposurefieldsignalrelaybetweentheX-raydeviceandtheAeroDRGeneratorInterfaceUnit.(13) AeroDRS-SRMCable*1PerformssignalrelaybetweentheX-raydeviceoperationpanelandtheAeroDRGeneratorInterfaceUnit.(14) S-SRM*1SynchronizesAeroDRGeneratorInterfaceUnitandX-raydevicesimply.ExposureisperformedusingtheAeroDRGeneratorInterfaceUnit.*1Optionalproduct.*2TheAccessPointcanalsobeusedwithcommercialitems.
33Chapter 22.1Overviewofthisdevice Basic connection example 1X-ray(11) AeroDR XG CableTubeX-ray deviceWired connection(1) AeroDR DetectorExposure room Wireless connection(1) AeroDR DetectorWall stand(9) AeroDR UF Cable(2) AeroDR Interface Unit(8) AeroDR I/F Cable (7) Access Point(5) AeroDR Battery Charger (4) AeroDR Generator Interface UnitSignal relayPower supplyX-ray deviceoperation panel(10) Image processing controllerHub(12) AeroDR Collimator Cable Basic connection example 2X-ray(11) AeroDR XG CableTubeX-ray device(1) AeroDR Detector (1) AeroDR DetectorWall stand (9) AeroDR UF Cable(3) AeroDR Interface Unit2(8) AeroDR I/F Cable (7) Access Point(5) AeroDR Battery ChargerSignal relayPower supplyX-ray device operation panel(10) Image processing controllerHub(12) AeroDR Collimator CableWired connectionExposure room Wireless connection
342.1Overviewofthisdevice Aero Sync connection exampleWired connection(1) AeroDR DetectorExposure room Wireless connection(1) AeroDR DetectorWall stand(9) AeroDR UF Cable(8) AeroDR I/F CableX-ray(7) Access PointX-ray device operation panel(10) Image processing controller(2) AeroDR Interface UnitHubTubeX-ray device(5) AeroDR Battery ChargerSignal relayPower supply S-SRM connection example 1(14) S-SRMHubWired connection(1) AeroDR DetectorExposure room Wireless connection(1) AeroDR DetectorX-ray(9) AeroDR UF Cable(2) AeroDR Interface Unit(8) AeroDR I/F Cable (7) Access Point(5) AeroDR Battery Charger(4) AeroDR Generator Interface UnitSignal relayPower supplyX-ray deviceoperation panelTubeX-ray device(10) Image processing controller(13) AeroDR S-SRM CableWall stand
35Chapter 22.1Overviewofthisdevice S-SRM connection example 2(14) S-SRMHubWired connection(1) AeroDR DetectorExposure room Wireless connection(1) AeroDR DetectorX-ray(9) AeroDR UF Cable(8) AeroDR I/F Cable (7) Access Point(5) AeroDR Battery Charger(3) AeroDR Interface Unit2Signal relayPower supplyX-ray deviceoperation panelTubeX-ray device(10) Image processing controller(13) AeroDR S-SRM CableWall stand
3622 Component names and functions221 AeroDR DetectorThecomponentnamesandfunctionsoftheAeroDRDetectorareasfollows.(8)Protectivecover(2)Powerswitch (4)Shockwatch*(7)Selectionswitch(9)Wiredconnectionconnector(4)Shockwatch(5)ExteriorExposureside(8)Protectivecover(6)LEDs(3)Antennadisplay(5)Exterior(8)Protectivecover(4)Shock-watch(4)Shock-watch(3)Antennadisplay(1)TriangularmarkNumber Name Functions(1) TriangularmarkIndicatesthedirectiontoplacetheAeroDRDetectorinduringexposure.Whenexposinginportrait,placethetriangularmarkupward.Whenexposinginlandscape,placethetriangularmarktotheleftorright.(Leftandrightaresetduringinstallationaccordingtotheexposureenvironment.)Reference••••••••••••••••••••••••••••••••••••••••••••••••••• FortheplacementoftheAeroDRDetectorduringexposure,referto"3.2.2AeroDRDetectororientation".••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••(2) Powerswitch UsedtoturntheAeroDRDetectoron/off.(3) Antennadisplay Displaystheplacewhereawirelessantennaisattached.(4) ShockwatchBecomesrediftheAeroDRDetectorissubjectedtoacertainamountofshock.*AeroDR1012HQisequippedwithonlyoneShockwatch,whichisindicatedby"(4)Shockwatch*"intheabovepicture.(5) Exterior Protectstheinternalparts.(6) LEDsDisplaysthestatusoftheAeroDRDetector.Reference••••••••••••••••••••••••••••••••••••••••••••••••••• ForthedisplaypatternsandstatusoftheLEDs,referto"4Status(LED)Display".••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••(7) Selectionswitch NotiestheimageprocessingcontrollerthatthisAeroDRDetectorwillbeusedfortheexposure.(8) Protectivecover Absorbsexternalshocks.(9) WiredconnectionconnectorConnectstotheAeroDRBatteryCharger/AeroDRBatteryCharger2,AeroDRI/FCable,andAeroDRUFCable.
37Chapter 22.2Componentnamesandfunctions222 AeroDR Interface UnitThecomponentnamesandfunctionsoftheAeroDRInterfaceUnitareasfollows.(9)Spacer(5)Exhaustoutlet(1)Topcover(7)LEDs(6)Frontcover(2)Sidecover (4)Rearcover(3)Powerswitch(8)CableoutletNumber Name Functions(1) Topcover Protectstheinternalparts.(2) Sidecover Protectstheinternalparts.(3) Powerswitch TurnstheAeroDRInterfaceUniton/off.(4) Rearcover Protectstheinternalparts.(5) Exhaustoutlet Exhaustsinternalheat.(6) Frontcover Protectstheinternalparts.(7) LEDsDisplaysthestatusoftheAeroDRInterfaceUnit.Reference••••••••••••••••••••••••••••••••••••••••••••••••••• ForthedisplaypatternsandstatusoftheLEDs,referto"4Status(LED)Display".••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••(8) Cableoutlet Outletforvariouscables.(9) Spacer Preventsexhaustoutletfrombeingblockedafterinstallation.
382.2Componentnamesandfunctions223 AeroDR Interface Unit2ThecomponentnamesandfunctionsoftheAeroDRInterfaceUnit2areasfollows.(1)Exhaustoutlet(7)Spacer(10)Cableoutlet(6)Sidecover (9)GeneratorInterfaceLEDs(8)Frontcover(7)Spacer(1)Exhaustoutlet (2)Topcover(4)Powerswitch(6)Sidecover(5)Rearcover(11)Handswitch(3)DetectorConnectionLEDsNumber Name Functions(1) Exhaustoutlet Exhaustsinternalheat.(2) Topcover Protectstheinternalparts.(3) DetectorConnectionLEDsDisplaysthestatusoftheAeroDRInterfaceUnit2.Reference••••••••••••••••••••••••••••••••••••••••••••••••••• ForthedisplaypatternsandstatusoftheLEDs,referto"4Status(LED)Display".••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••(4) Powerswitch TurnstheAeroDRInterfaceUnit2on/off.(5) Rearcover Protectstheinternalparts.(6) Sidecover Protectstheinternalparts.(7) SpacerPreventsexhaustoutletfrombeingblockedafterinstallation.*Nospacersmaybeprovidedonsomesidecoversthatwillnotcomeincon-tactwithwalls.(8) Frontcover Protectstheinternalparts.(9) GeneratorInterfaceLEDsDisplaysthestatusoftheAeroDRInterfaceUnit2.Reference••••••••••••••••••••••••••••••••••••••••••••••••••• ForthedisplaypatternsandstatusoftheLEDs,referto"4Status(LED)Display".••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••(10) Cableoutlet Outletforvariouscables.(11) Handswitch WhenS-SRMconnectionisadopted,ahandswitchisinstalledintheAeroDRInterfaceUnit2.
39Chapter 22.2Componentnamesandfunctions224 AeroDR Generator Interface UnitThecomponentnamesandfunctionsoftheAeroDRGeneratorInterfaceUnitareasfollows.(8)Spacer(4)Exhaustoutlet(1)Topcover(6)LEDs(5)Frontcover(2)Sidecover (3)Rearcover(9)Handswitch(7)CableoutletNumber Name Functions(1) Topcover Protectstheinternalparts.(2) Sidecover Protectstheinternalparts.(3) Rearcover Protectstheinternalparts.(4) Exhaustoutlet Exhaustsinternalheat.(5) Frontcover Protectstheinternalparts.(6) LEDsDisplaysthestatusoftheAeroDRGeneratorInterfaceUnit.Reference••••••••••••••••••••••••••••••••••••••••••••••••••• ForthedisplaypatternsandstatusoftheLEDs,referto"4Status(LED)Display".••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••(7) Cableoutlet Outletforvariouscables.(8) Spacer Preventsexhaustoutletfrombeingblockedafterinstallation.(9) Handswitch WhenS-SRMconnectionisadopted,ahandswitchisinstalledintheAeroDRGeneratorInterfaceUnit.
402.2Componentnamesandfunctions225 AeroDR Battery ChargerThecomponentnamesandfunctionsoftheAeroDRBatteryChargerareasfollows.(1)Rearcover(8)LEDs(9)Frontcover(4)Sidecover(5)Charge/registrationlabel(3)Topcover(4)Sidecover(6)AeroDRDetectorinserttable(front)(10)Roller(7)AeroDRDetectorinserttable(side)(2)SlidecoverNumber Name Functions(1) Rearcover Protectstheinternalparts.(2) Slidecover Protectstheinternalparts,andpreventsdustfromgettinginsidetheAeroDRBatteryCharger.(3) Topcover Protectstheinternalparts.(4) Sidecover Protectstheinternalparts.(5) Charge/registrationlabelWhenanAeroDRBatteryChargerexclusivelyforchargeisused,alabelthatdistinguishestheAeroDRBatteryChargerexclusivelyforchargefromanAeroDRBatteryChargerthatisusedforchargeandregistrationisafxed.(6) AeroDRDetectorinserttable(front) GuideforinsertingtheAeroDRDetectorfromthefront.(7) AeroDRDetectorinserttable(side) GuideforinsertingtheAeroDRDetectorfromtheside.(8) LEDsIndicatesthestatusbetweentheAeroDRDetectorandtheAeroDRBatteryCharger.Reference••••••••••••••••••••••••••••••••••••••••••••••••••• ForthedisplaypatternsandstatusoftheLEDs,referto"4Status(LED)Display".••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••(9) Frontcover Protectstheinternalparts.(10) Roller PreventsexternalfrictionwhenyouinserttheAeroDRDetector.
41Chapter 22.2Componentnamesandfunctions226 AeroDR Battery Charger2ThecomponentnamesandfunctionsoftheAeroDRBatteryCharger2areasfollows.(4)Stand(14)LANconnector(3) Frontinsertguide(2)Wiredconnec-tionconnector(1)Connectorcover(5)Frontcover(9) Rearinsertguide(10)Rearcover(11)Sidecover(left)(12)AeroDRDetectorinserttable(6) Sidecover(right)(7) Powerswitch(8)Inlet(13)LEDsNumber Name Functions(1) Connectorcover Protectsthewiredconnectionconnectorandpreventsdustfromenteringinsideit.(2) Wiredconnectionconnector ConnectstothewiredconnectionconnectoroftheAeroDRDetector.(3) Frontinsertguide Protectstheinternalparts.(4) Stand ProtectstheAeroDRBatteryCharger2frombeingoverturned.(5) Frontcover Protectstheinternalparts.(6) Sidecover(right) Protectstheinternalparts.(7) Powerswitch UsedtoturntheAeroDRBatteryCharger2on/off.(8) Inlet ConnectstothepowercableofAeroDRBatteryCharger2.(9) Rearinsertguide Protectstheinternalparts.(10) Rearcover Protectstheinternalparts.(11) Sidecover(left) Protectstheinternalparts.(12) AeroDRDetectorinserttable AguideforinsertingtheAeroDRDetector.(13) LEDsDisplaysthestatusoftheAeroDRDetectorandAeroDRBatteryCharger2.Reference••••••••••••••••••••••••••••••••••••••••••••••••••• ForthedisplaypatternsandstatusoftheLEDs,referto"4Status(LED)Display".••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••(14) LANconnector ConnectstotheEthernetcable.
422.2Componentnamesandfunctions227 Access PointThecomponentnamesandfunctionsoftheAccessPointareasfollows.HINT •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• Theillustrationsandexplanationmerelyshowsanexample.•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••Reference•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• Fordetails,refertoeachdevice'smanual.•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••(2)10/100BASE-T(X)RJ45port(3)Antennaport(4)AntennaCannotbeusedwiththisdevice(1)LEDsNumber Name Functions(1) LEDsDisplaysthestatusoftheAccessPoint.Reference••••••••••••••••••••••••••••••••••••••••••••••••••• ForthedisplaypatternsandstatusoftheLEDs,referto"4Status(LED)Display".••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••(2) 10/100BASE-T(X)RJ45port UsedforconnectiontotheAeroDRInterfaceUnit/AeroDRInterfaceUnit2.(3) Antennaport Porttoattachantenna.(4) Antenna Receiveswirelesssignal.
43Chapter 22.2Componentnamesandfunctions228 AeroDR I/F CableThecomponentnameandfunctionoftheAeroDRI/FCableareasfollows.(1)SpringconnectorNumber Name Functions(1) Springconnector ConnectstothewiredconnectionconnectoroftheAeroDRDetectororAeroDRUFCable.229 AeroDR UF CableThecomponentnamesandfunctionsoftheAeroDRUFCableareasfollows.(2)Wiredconnectionconnector(1)SpringconnectorNumber Name Functions(1) Springconnector ConnectstothewiredconnectionconnectoroftheAeroDRDetector.(2) Wiredconnectionconnector ConnectstothespringconnectoroftheAeroDRI/FCable.
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