Shimadzu WHA-200 Opescope C-Arm - SM

11/28/2016
OPERATIONMANUAL
Page1
OPERATIONMANUAL
ARCFORPROCEDURES
SURGICALANDVASCULARWHA200
MODS.OPESCOPEACTIVOE
OPESCOPEPLENO
Version1.6inPortuguese
Tousetheproductcorrectly,readthroughthe
Thismanualandkeepitas
Futureconsultations.
TheoperatingmanualwasoriginallywritteninEnglish.
https://translate.googleusercontent.com/translate_f
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INSTRUCTIONSFORUSE
BowforSurgicalandVascularProceduresWHA200
MODS.OPESCOPEACTIVOANDOPESCOPEPLENO
SHIMADZUCORPORATION
ImporterandDistributorinBrazil:
ShimadzudoBrasilComrcioLtda.
Av.MarqusdeSoVicente,n1771
SaoPauloSP
Authorization/MS:1036901
Manufacturer:
ShimadzuCorporation
1,NishinokyoKuwabaracho
NakagyoKu
Kyoto6048511Japan
InternationalDistributors:
ShimadzuCorporation
1,NishinokyoKuwabaracho
NakagyoKuKyoto6048511
Japan
ShimadzuCorporation
TokyoOffice,3
KandaNishikicho1chome
Chiyodaku,Tokyo1018448
Japan
ShimadzuMedicalSystems,
USACompany
20101SouthVermontAve.
Torrance,California90502
USA
ShimadzuEuropaGmbH
AlbertHahnStrasse610,
47269
Duisburg,FR
Germany
ShimadzuMedical(INDIA)
PVT.LTD.
1stfloor,1063,Munusamy
Salai
KKNagar,Chennai600078
India
ShimadzuMedicalSystems
(OCEANIA)PTY.LTD
UnitsE,1016SouthStreet
Rydalmere,NSW2116
Australia
Shimadzu(HongKong)LTD.
Suite1028OceanCenter
HarborCity,TsimShaTsui
Kowloon,HongKong
ShimadzuInternational
Trading(Shanghai)CO.LTD
BeijingOffice14F
ChinaLifeTower,No.16
ChaoyangmenwaiStreet
ChaoyangDistrict
Beijing100020PR
China
BeijingShimadzuMedical
EquipmentCO.LTD.
No.207LongShengIndustry
ZoneNo.7RongChangDong
street
BeijingEconomicTechnology,
Developmentarea
Beijing100176PR
China
Producttechnicalname:ARCOSURGICAL
TechnicalDirector:ConstantineLuizDiPIPICREA/SP0682526854
ANVISARegistrationNo:10369010062
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ActiveOpescopeSetting:
XRayTube
XrayControllerUnit
Collimator
XrayGenerator
CarHolderwithCBow
ImageIntensifier
TVsystemwithCCDcamera
LCD/TFTmonitor(s)
Monitorstand(s)
Cassetteholder
FullOpescopeSetup
XRayTube
XrayControllerUnit
Collimator
XrayGenerator
CarHolderwithCBow
ImageIntensifier
TVsystemwithCCDcamera
LCD/TFTmonitors
MonitorStand
Cassetteholder9"
Optional
ClearprotectivecoverforCbow(disposablewith
50units/carton)
Transparentcoverformonotank(disposablewith
100units/carton)
TransparentprotectivecoverforImageEnhancer(disposable
With100units/box)
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Sterilizablecoverforarcc,monotankand
images
Sterilizableprotectioncoverformonotankand
7"pictures
9"pictures
6pictures
IndicatorLaser(laserpointer)toII7"
IndicatorLaser(laserpointer)for9II"
IndicatorLaser(laserpointer)for6II"
Dualstagetrigger
FibergrillforII7"
FibergrillforII6"
FibergrillforII9"
ControlknobforIl
Cineloopmemory(ACTIVEonly)
DigitalImagingUnitwith
Digitalsubtraction(DSA)(ACTIVEonly).
MODrecorder(ACTIVEonly)
MODmedia(ACTIVEonly)
Videoprinter(thermalprinter)
DVDR/RWrecorder
LCD/TFTwithtouchscreen(touchscreen)
DICOMStorageKit(includedwithCDROMwithsoftware)
DICOMPrintKit(includingsoftwareCDROM)
DICOMWorklistKit(includedwithCDROMwithsoftwareandPC,
ConsistingofMonitor,CPU,MouseandKeyboard)
Fluoroimagedisplayfunctiononthearcscreen(Only
FULL)
XrayDoseMeterDAP(PLENARYOnly)
ExtensionofEmittingSourceSkinDistance.
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Page5
StorethismanualcarefullyalongwiththeOpescope.
Thesymbolsshowninthismanualfollowbelow.
Alertthatindicatesdirectdangerandmaycausedeathorseriousinjuryif
Notbeavoided.
Alertindicatingapotentialhazardwhichcouldcausedeathorserious
Damageifnotavoided.
Hazardwarningthatcancauseslightdamagetothepatientordamagetothe
Equipmentorfireifnotavoided
Alertswithinformationthatcanhelpyouusethesystemcorrectly.
IndicationofReferences
ProvidesinformationtomakeiteasiertouseOpescope
ProvidesinformationforreferencewhenOpescopeisused.
AbbreviationsandSpecialTerms
ReferringtoFig.
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Introduction
WethankyouforchoosingtheArchforSurgicalandVascularProcedures
OPESCOPEACTIVO/OPESCOPEPLENO.
Beforeusingtheproduct,readtheoperationmanualandmakesurethe
Understandingofitscontent.
Afterreadingthismanual,storeitinasafeplace
Accessedeasily.
Copyright
ShimadzuCorporationownsthecopyrightsinthismanualandpartof
Contentorallofitcannotbecopiedorreproducedwithoutdue
AuthorizationfromShimadzuCorporation.
Thecontentsofthismanualcanbemodifiedforimprovementswithoutany
Notice.
ShimadzuCorporationAllrightsreserved.
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OperatingPrecautions
1.Onlyqualifiedpersonnelshouldoperatetheequipment.
2.Wheninstallingtheequipment,payattentiontothefollowingitems:
(2.1)Donotinstalltheequipmentnearwatertapsorsimilar.
(2.2)Installawayfrompotentialsourcesofpressure,temperatureor
Moisture,directsunlight,hydrochloricorsulfurdustorgases.
(2.3)Duringtransportandoperationoftheequipmentavoidvibrations,
Inclinations,shocksandimpacts.
(2.4)Keepequipmentawayfromareaswheregasesorchemicals
Arestored.
(2.5)Useonlytherecommendedpowersource(frequency,currentand
voltage).
(2.6)Checktheconditionsofthebattery'spowersource(powerand
Polarity)beforeoperatingtheequipment.
(2.7)Properlygroundtheequipment.
3.Beforeoperatingtheequipment,payattentiontothefollowingitems:
(3.1)Checktheconditionsofthesockets,polarity,etc.
(3.2)Checkthatgroundingisconnectedcorrectly.
(3.3)Checktheelectricalinstallation.
(3.4)Payattentionwhenusingmorethanoneelectricalequipment,
Maycauseanincorrectdiagnosisorcausedamage.
(3.5)Checktheconditionoftheexternalelectricalcircuit,whichwillbe
Connecteddirectlytothepatient.
(3.6)Checktheconditionofthebatterypowersource
4.Whileoperatingtheequipment,payattentiontothefollowingitems:
(4.1)Donotexceedexposuretimefordiagnosisortherapy.
(4.2)Observethepatientandtheequipmentconstantlyfordetection
Problems.
(4.3)Whenaproblemisdetectedwiththeequipmentorpatient,
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Takethenecessarystepstostoptheequipmentwithout
Hurtthepatient.
(4.4)Donotlettheequipmenttouchthepatient.
5.Afteroperatingtheequipment,payattentiontothefollowingitems:
(5.1)Turnoffthekeysandreturnthedialtoitsoriginalposition.Then,turnoff
Themainkey.
(5.2)Donotpullthepowercordviolentlyfromtheoutlet.
(5.3)Whenstoringtheequipment,payattentiontothefollowing
items:
(I)Keepawayfromwater.
(Ii)Storeawayfrompotentialcausesofproblemssuchas
Abnormalpressure,temperatureandhumidity,airflow,sunlight
Direct,dust,chlorineorsulfurgas.
(Iii)Duringtransportationandstorageofequipment,avoid
Inclinations,vibrationsandimpacts.
(Iv)Storeequipmentawayfromstorageareas.
Chemicalsandgases.
(5.4)Cleanallaccessories,cables,andcontacts,andstoretheminalocation
Appropriate.
(5.5)Keepequipmentcleantoavoidproblemsduringoperation.
Nextuse.
6.Whenequipmentisbroken,donotattempttorepairit.
Properlyidentifyandcontacttheauthorizedservicecenter.
7.Donotmodifyanypartoftheequipment.
8.PreventiveMaintenance
(8.1)Theequipmentanditspartsshallbeperiodicallytested.
(8.2)Iftheequipmentisnotinoperationforanextendedperiod,
Testbeforeusetoensure
Evenifitisworkingproperlyandsafely.
9.Forotheritems,usethemaccordingtotheoperatinginstructions.
ReferringtoFig.
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Usingthesystemsafely...
Onlyqualifiedpersonnelshouldusethesystem.
Theresponsibilitytocontroltheuseandmaintenanceofmedicalequipment
Fallsontheuser(s)ofthesystem.
Onlyqualifiedpersonnelortheirsubordinatesmayusethesystem.
Itisdangeroustocarryoutinternalrepairsorinspections,
Ifrepairs/inspectionsarenecessary.
Donotmodifythesystem.
Ingeneral,allmodificationsarestrictlyprohibitedbytherequirements
Regulatoryframeworks.Pleasecontactyourauthorizedservice
Anymodification.
Performperiodicinspections.
Tomaintainsystemsecurityandperformanceforalongtime,
Performpreventivemaintenance.
Repairsandmaintenanceoftheequipmentcanonlybeperformed
Technicalassistanceorauthorizedtechnicians
ReferringtoFig.
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MainPointstoWatch
Beforeusingtheproduct,readtheoperationmanualandmakesurethe
Understandingofitscontent.
Theuseofthesystemwithoutreadingthismanual,orwitha
Incompleteunderstandingoftheinformationofitscontents,cancauseserious
Damagetotheequipment.
Donotturnonthepowerortouchthebuttonsorothercontrolswithoutfirst
Havereadtheinstructionmanual.
IfyoudonotunderstandanypartoftheInstructionManual,please
Contactyourauthorizedservicecenter.Contactdetailswillbe
Theendofthemanual.
Storeitinasafeplacethatcaneasilybeaccessedwhen
Necessary.
Familiarizeyourselfwiththelocationsofrisksandthenatureoftheserisks.
Makesureeverythinghasbeendonetoavoidsuchrisksandactions.
Correctivemeasurestobetakenintheeventofsomeofthese
Happen.
Onlyqualifiedpersonnelshouldusethesystem.
Theresponsibilitytocontroltheuseandmaintenanceofmedicalequipment
Fallsontheuser(s)ofthesystem.
Onlyqualifiedpersonnelortheirsubordinatesmayusethesystem.
Itisdangeroustocarryoutinternalrepairsorinspections,
Ifrepairs/inspectionsarenecessary.
Donotmodifythesystem.
Ingeneral,allmodificationsarestrictlyprohibitedbytherequirements
Regulatoryframeworks.Pleasecontactyourauthorizedservice
Anymodification.
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LocationofRisks
HighVoltageSection
Nevertouchtheinternalpartsoftheequipment,asitcontains
Highvoltagesectors.
Thiscouldresultinseriousaccidentsincludingdeathby
electrocution.
Figure1HighVoltageSection
Inspectthecableusedinthesystem.
Checktheinsulationofthecableoranydamagebeforeusingit.
inthesystem.
Insulationfaultscancauseseriousaccidentsincludingdeath
byelectrocution
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MovingSection
Beawareofhazardswhentouchingequipment
Youcaninjureyourarmsorlegsbypositioningthembetween
Carmandtherestofthestructure.
WhenmovingtheCarm,grasponlyattheappropriatepointsand
Operatecarefully.
Donotplaceanyperipheraldevicesoranyother
Intherangeofmovementoftheequipment
Thelaserbeamgeneratedhasawavelengthof630nm
(Nanometers)andtheoutputislessthanmWandconsequentlyis
CharacterizedasaClassIIlaserbytheFDAandasalaser
Class3AbytheIEC.
Figure2RangeofMotion
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PreventiveMaintenanceNotes
PerformPeriodicInspections.
Preventivemaintenancewillberequiredtomaintainsafety
Andsystemperformance.
Maintenanceshouldonlybecarriedoutbytechniciansor
Authorizedtechnicalassistance.
Repairsandmaintenanceshouldonlybeperformedby
Techniciansand/orauthorizedtechnicalassistance.
RadiationCare
Beawareofxrayirradiation.
Iftheequipmentisnotusedproperlybytheuser,the
Patientandothersmayreceiveahigherdoseof
Radiationthannecessary.Nooneelse,exceptthepatientandthe
Personsstrictlynecessaryfortheprocedure(staff
Doctor)shouldremainintheexaminationroomduring
Exposureofxrays.Ifforsomereasonanotherperson
Needtostayinsidetheexaminationroom,itshouldtakethe
Measurestoprotectagainstradiation.
Tominimizetheabsorbeddose,focusthe
Asfaraspossible.
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Careofthelaserbeam
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Thelaserbeamgeneratedhasawavelengthof630nm
(Nanometers)andtheoutputislessthanmWandconsequentlyis
CharacterizedasaClassIIlaserbytheFDAandasalaser
Class3AbytheIEC.
Neverlookdirectlyatthelaserbeam.
Whenlookingatthelaserbeam,theeyescanbeinjured.
Turnontheequipmentonlywhennecessarytoavoid
Unnecessaryexposure.
Donotattemptanyoperation,adjustmentorprocedurethatdoesnot
Describedinthismanual.
Explosioncare
Equipmentnotsuitableforuseinthepresenceofa
Inflammableanestheticmixturewithair,oxygenor
nitrous.
Takecarewhenusingdisinfectantspray.
Donotusespraydisinfectantsthatareflammableastheymay
Causeexplosions.
Vaporfromadisinfectantspraymaytriggeranexplosion
Causingdeaththreatstothesurroundingpeopleanddamageto
system.
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FlameCare
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Implementmeasurestoeliminateflames.
Usingthesysteminanunsuitableenvironmentmaycause
Fireorexplosion.
Installappropriatefireextinguishersandensurethatthe
Procedurefordealingwithfiresiswidelyknown.
Usefireextinguishersuitableforfire
Chemicalandelectrical.
Usingwaterorotherliquidsinfirefighting
Cancauseseriousdamage.
Cellphonerelatedcare
Keepcellphonesorthelikeoutoftheroom.
exam.
Donotplacedevicesthatemitelectromagneticwaves(eg
Cellphones)withintheexaminationroom,evenif
Off.Suchdevicesmayexceedthewave
Electromagneticfields,andundercertainconditionsmay
Functioningofthesystem.Intheworstcase,itcancauseserious
Damagesorclinicalerrors.
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Careaboutfieldcompatibility
electromagnetic
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TheWHA200requiresspecialprecautionsregardingEMC
(ElectromagneticCompatibility)andneedstobeinstalledand
UsedinaccordancewiththeEMCinformationprovidedinthis
Operatingmanual.
Checkthattheelectromagneticfieldsarecompatible.
Allperipheraldevicesmustconformtothe
EMCstandardsfortheemissionofelectromagneticwavesand
Sensitivitytoemitelectromagneticwaves.Devicesthat
Donotmeetthesestandardsmaycausethe
Thesystem.Intheworstcase,itcouldcauseseriousdamageor
Errors.
TheWHA200shouldnotbeusedtooclosetoorstackedwith
Otherequipment,butifuseinthiswayisnecessary,the
WHA200shouldbeconstantlymonitoredtoverifythe
Normaloperationintheconfigurationwhichwillbeused.
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Cleaninganddisinfectioncare
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Cleaninganddisinfectionofthesystem.
Cleaninganddisinfectionareveryimportanttoensurethat
Thesystemwillbecleanandsafetouse.
Disconnectthemainpowercablebeforestartingthe
cleaning.
Itisstrictlynecessarytoswitchtheunitoffbeforestartingthe
Cleaninganddisinfecting.
Otherwise,thereisariskofelectricshock.
Donotusewaterinthesystem.
Cleanthesystembywipingwithaclothmoistenedwithdisinfectant.
Usingwatertocleanthesystemmaycause
Electricalinstallations.
Donotapplydisinfectantorspraydirectlyonthe
equipment.
Ifdisinfectantentersthesystem,itmaycauseproblemsor
Accidents.
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Cautiononuseandstorage
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Installasatisfactoryground.
Thesystemrequiresgrounding.
Unsatisfactorygroundingmaycauseelectricshock.
Usetheequipmentinanenvironmentthatmeetsthe
Guidelinesaddressedhere.
Usetheequipmentonlyinanareaorroomthatis
Accordancewithgovernmentalandelectricallysafelawsforthis
kindofequipment.
Conditionsforproperuseandstorage.
Thelocationwheretheequipmentwillbeusedandstoredshall
Followingconditions:
Atmosphere:Cannotbeexplosiveorcontaincorrosivegases
Temperature:10Cto40C
Relativehumidity:30%to80%(noncondensing)
Atmosphericpressure:700hPaat1060hPa
Note:theenvironmentshouldnotundergosudden
Humidityortemperature,asthismaycausesystemproblems.
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Caringforthesystem
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Becarefulofimpactsorsystemcrashes.
Thesystemweighsmorethan200kg.
Impactsandfallswilldamagethesystemandcauseseriousdamageto
Peoplewhoaremanipulatingit.
Whenmovingthesystem,payattentiontothefollowingpoints:
CheckthattheCarmisinthetransportposition.
Whenyouarecrossingrampsorentrances,and
Movethesystemassmoothlyaspossible.Becareful
Particularlyonsteepramps.
Alwaysusethebrakewhenstoppingthesystem.
Onrampswithaslopegreaterthan5,thesystemmayfall.
Donotmoveoroperatetheequipmentinlocationswherethe
Exceed5.
Whenmovingthesysteminplacesthatgeneratestrongvibrations,
Outdoors,avoidrapidprogress,stop
Abrupt,andsteepramps.Donotstoptheequipmentonroutes
Sloping.
Whilemovingthesystem,becareful
obstacles.
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WarningLabels
Donotremoveordamagethewarninglabels.
Warninglabelsindicateimportantcarewhenusing
thesystem.
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Ifthelabelisunreadablecontacttheauthorizedservice.
Figure3WarningLabels
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CAUTION
Fordriving,turntheCArmtothe
Position.
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CAUTION
CRUSHING
Donotputyourhandhere.
WARNING
ThisXrayunitcanbedangerous
Forthepatientandoperatorunlessthe
Safeexposurefactors,exposure
Operationandmaintenancescheduling
Areobserved.
WARNING
RISKOFEXPLOSION
Donotuseinthepresenceofanesthetics
Flammable.
CAUTION
RISKOFFALL
Donotusetheequipmentonafloor
Withaslopegreaterthan5degrees.
CAUTION
RISKOFELECTRICSHOCK
Keeptheequipmentdry.
CAUTION
LASERRADIATION
DONOTLOOKFORLASER
1.0mWMax.CW645nm
ClassIILaserProductIEC608251
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Warrantyterm
ShimadzudoBrasilComrcioLtdaguaranteesthenormaloperationfor
Allequipmentsuppliedbyit,againstdefectsorfailuresthatunderuse,
Maintenanceandoperation,occurdueto
Ormaterial,foraperiodoftwelve(12)months,countedfromthedateof
Terminationoftheinstallationandconsequentacceptanceofthe
Maynotexceedfifteen(15)months
OftheBillofLadingorBillofSale,
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Whicheveroccursfirst.Thebuyershallcommunicateinwritingtothe
Shimadzu,anydefectsthatmayoccur,withtheevidence
Satisfactory,assoonaspossible.
Defectiveparts,whichareundertheWarrantyperiod,willbe
ReplacedorrepairedatShimadzu'sdiscretionandwithoutchargetothepurchaser.
ThecostsrelatedtothestayandtraveloftheEngineersand/or
Shimadzuanditsrepresentatives,whentheequipmentisinstalled
OutsidethecityofSoPaulo,oroutsidethehostcityofoneoftheRepresentatives
Aswellasotherexpensesnecessaryforsuch
Becoveredbythebuyer.Thereplacementofpartswillbedoneinthesame
Purchaseofequipment.Therepairorreplacementofpart
Equipmentdoesnotextendorinterruptthewarrantyperiod.AShimadzu
Reservestherighttorequestthereturnofreplacedpartsandcomponents
UnderWarranty.
ExceptfortheGuarantee,anyandallobjectssubjecttothe
Deterioration,naturalwearorconsumption,suchas:accumulators,batteries
Droughts,rubberorplasticobjects,includingprotective,filmandphoto
Chemicalproducts,incandescentbulbs,cablesingeneral,materials
Processing,etc.
Defectsordamagesresultingfromaccidentsarealsoexcluded.
Suchas:fires,floods,electricpowerlines,shocks
Maintenance,cleaning,improperuseof
Equipmentornegligence.Alsonotincludedinthiswarranty
Anyindemnityforlossofprofit,personalinjuryandotherproperty.
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Chapter1
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WHA200Overview
OPESCOPEACTIVE/FULL
ThischapterprovidesanoverviewoftheWHA200OPESCOPEACTIVEand
Describestheenvironmentalcharacteristicsandconditionswhichshouldbeused.
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1.1Outline
Thisequipmentisamobileimagingsystemforradiographyand
Fluoroscopyforuseduringsurgery,
AswellasinXrayexaminationrooms.
Pleaseattachtheoptional"ExtensionKitforSourceSkinDistance"
Whentheequipmentisusedforanotherapplicationthan
Forsurgerypurposes.
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1.1.1AbouttheWHA200Active/FullOpescope
Innormalconfiguration,themonitorstandhasamonitor
(Forlivefluoroscopyonly).Theexamplebelowreferstothe
Configurationwith2monitors,whichoneisoptional.
Figure1.1SystemOverview
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1.2Features
Thisunitincorporatesthefollowingsupportfeaturestoenable
Radiographyandsmoothedfluoroscopywhileensuringfunctionalityand
Requiredintheoperatingroomsand
Emergencies.
Highimagequality
ThesystemincorporatesaCCDcameraandaveryhighxraytube
Capacityandhighdissipationforhigh
Withoutexposuretimelimits.
Lowirradiation
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Inthefluoroscopypulse,xraysareemittedasapulse.ITIS
Possibletochoosethelowdosemodethatminimizesirradiationand
Highqualitypicturemodeaccordingtoyourneeds.
The"LastImageHold"functionis
Forcaseswherefluoroscopyisnotrequiredforconfirmation.
Eightimagescanbestoredinmemory.
Speed
Thefreedomofmovementfacilitatesthepositioningofthesystemto
Workonanylimborspine,whichhelpsreducetime
Positionandthetimerequiredforsurgery.
Lightweightandcompact
Thesystemwasmadewithfreeandcompactangle.
Cleaning
ThecablesareembeddednexttotheCarm,sotheydonotgointo
Contactwiththepatientorsurgicalinstruments,allowingthesafeuseof
ofthesystem.
LastImageMaintenance
(LIH)
ThelastXrayimageisdisplayedonthemonitor.
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1.3EnvironmentalConditions
1.3.1ConditionsofUse
Inorderfortheequipmenttoachievetheintendedperformance,
Itmustbeusedundertheconditionslaiddown.
Environmentalconditions
Usetheequipmentinanenvironmentwiththe
Specifiedbelow.
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Evenwhenthefollowingconditionsaremet,
Makesurethattherearenosuddenchangesin
Temperatureorhumidity.
Thisleadstocondensation,whichcancauseproblems.
Condition
Stipulation
Temperature
10Cto40C
Relativehumidity
30%to85%(noncondensing)
Atmosphericpressure
700hPaat1060hPa
Atmosphereconditions
Theatmospheremustbefreeof
Corrosiveandexplosivegases
Powersupply
Thepowersourcemusthavethefollowingcharacteristics.
Phase
singlephase
B.C
Voltage
100,110,120V10%,0.2
Max.
200,220,230,240V10%,
0.8max.
Capacity
3.5kVAor
larger
Frequency
50or60Hz
Selectoneofthevoltagesindicatedaboveatthetimeof
installation.
26.
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Donotusethepowersourcethatdoesnotconformtothe
Rulesabove.
Theuseofanenergysourcethatisnotincompliancewiththe
Requirementsspecifiedabovecancauseserious
Involvingfire,smokegenerationandexplosion.
EarthRequirements
Theearthresistancemustbelessthan100ohm.
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Usealeakagecurrentbreakerthat
Harmonicoscillations.
1.3.2Storage
Evenwhenthefollowingconditionsaremet,
Makesurethattherearenosuddenchangesin
Temperatureorhumidity.
Thisleadstocondensation,whichcancauseproblems.
Condition
Stipulation
Temperature
10Cto40C
Relativehumidity
Atmosphericpressure
700hPaat1060hPa
Theatmospheremustbefreeof
Corrosiveandexplosivegases
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1.4ClassificationofDevices
1.4.1ClassificationaccordingtotheShockProtectionSystem
Electric.
ClassIDevices
ClassIdevicesarethosethatdependexclusivelyon
Basicinsulationforprotectionagainstelectricshock,inorderto
Toensurethatmetalpartsthatmaycomeintocontactwith
Ifthisbasicinsulationfails,donotcauseanelectricshock,
Throughthegroundwireinisprovidedasameasureof
Additionalsecurity.
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1.4.2ClassificationaccordingtoDegreeofProtectionagainstShocks
Electric.
TypeBDevices
TypeBdevicesaredevicesthatprovidealevelof
Particularprotectionagainstelectricshock,anditapplies
Especiallyintheallowableandreliableleakagecurrentandin
Protectiveearthconnections.
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1.4.3ClassificationaccordingtoDegreeofProtectionagainstEntry
HarmfulofWater.
StandardDevices
Usetheequipmentinaplacewherethereisnodangerof
Waterinlet.
Ifwatergetsinsidetheequipment,
Causeadangerouselectricshock.Donotallowwaterto
Reachthesurfaceoftheequipmentormoveinsideit.
Ifwatergetsintotheequipmentforanyreason,turnitoff
ImmediatelyandcalltheAuthorizedServiceCenter.
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1.4.4ClassificationaccordingtoDegreeofProtectionagainstShocks
Electric.
Equipmentnotsuitableforuseinaninpresenceenvironment
Ofaflammableanestheticmixturewithairoranestheticmixture
Flammablewithoxygenornitrousoxide.
Useinanenvironmentcontainingflammableanestheticgas
Maycauseanexplosion.
1.4.5ClassificationaccordingtotheModeofOperation.
Continuousoperationwithintermittentload
(ContinuousoperationdependsonthespecificationoftheXraytube
mounted)
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1.5SymbolsandNameplates
Manufacturer
1.5.1Symbols
Thesymbolsusedontheequipmentareindicatedbelow.
Symbol
Location
IdentificationPlate
Affixedtothehousing
Onthe
Force,wherethe
Protectionunit
Earth.
IdentificationPlate
Affixedtothehousing
CautionLabel/
Warning
Meaning
Alternatingcurrent
B.C
EarthProtection
Classificationof
Safety:
TypeBdevice
Referenceto
Manualof
Instructions
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driverof
PotentialEqualization
driverof
Equalization
Potential
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1.5.2Tags
Manufacturer'sIdentificationLabels
Manufacturer'sIdentificationLabelsareaffixedtotheindicatedlocations
below.
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Figure1.2LabelPosition
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Figure1.3ManufacturerIdentificationLabels
32
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Others
LabelsCertifiedbytheEuropeanUnionareaffixedtotheindicatedplace
Asnumber1infigure1.2.
TUVApprovedSticker
CEMarking
EuropeanRepresentative
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Figure1.4EuropeanUnionCertifiedLabels
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1.6OperatorProfile
Item
Age
Sex
Nationality
Education
Knowledge
Language
Experience
Details
AgethattheindividualcanobtainthelicenseofTechnician
Radiologyoranequivalentlicense.
withoutlimitation
withoutlimitation
Required
Eachoperatorneedstoconduct
Operatetheequipmentbeforeusingit.
Required
withoutlimitation
Required
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Chapter2
Configurationofthe
System
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Thischapterpresentsthesystemconfiguration.
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2.1StandardConfiguration
ThetwolargestcomponentsofthesystemaretheCarmsupportcar
Andstandwithmonitors.
2.1.1SupportCarwithArmC
TheCArmSupportCarcanbeoperatedtoreachposition
Moresuitableforfluoroscopyorradiography.
TheCArmSupportCarisconnectedtothemonitorcartusing
thesystem.
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Figure2.1CArmCart
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(1)IIControlKnob(optional)
Thisisthehandleusedbythesurgeontooperatethesystem.Thehandleisprovided
WithaCarmlockswitch.
(2)Xrayimageintensifierunit
TheabbreviationforimageintensifierisII
Xraysareconvertedtoavisibleimageonascreen
Thisfluorescentimageisconvertedtophotoelectronby
Photocathode,andthephotoelectronsareacceleratedandconvertedbyalens
Electrostatic,directingthemtothefluorescentoutputscreen.
(3)BeamLimitingDevice(Collimator)
ControlstherangeofXrayradiationwhenperformingfluoroscopyor
CaptureanXray.
(4)XrayGenerator
Thisisthexraygeneratingunit.Thexraytubeisoftheanodetype
fixed.
(5)SidePanel
Throughthispanelitispossibletolock/releasetheelectromagneticlocksofthe
ArmC,rotatethecamera/image,inverttheimage(up/downand
Right/left),open/closethecollimatorandactivatethememoryfunction.
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Figure2.2SidePanel
(6)ArmC
TheCarmiscounterbalancedandoperatedmanually.O
Iselectromagnetictype,andcanbeswitchedonoroffwitha
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Touch.Thearmcaneasilybepositioned.
(7)Mainpanel
Usedtodisplayandadjusttheradiologicaltechniques,writedatain
memory,andselectimagesdisplayedmemory.
Figure2.3aMainPanelACTIVE
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Figure2.3bMainPanelFULL
(8)Handlesformaneuver
UsedtomovethestandarmC
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(9)Parkingbrake
ThisistheparkingbrakemanualforthestandarmC
Figure2.4Parkingbrake
(10)Connector
Connectthemonitorstandstandout
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Figure2.5Connector
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(11)Pedal
Selectthefluoromode.
Leftfootswitch:continuousfluoroscopy,pulsedfluoroscopy
Switchrightpedal:Radiography
Figure2.6Pedal
Subtitle
1LeftPedalcontinuousfluoroscopy,pulsedorHighQuality
2RightPedalXray
(12)UnitXrayControl
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2.1.2CartMonitor
Thisisthestandofthemonitor,andisusedconnectedtothestandarmC,
andcontrolsthepowersupplytoallWHA200system.
Figure2.7MonitorStand
Onthedisplaymonitor
Dependingonthedisplayyoucanviewconditions
verysmalldotsorirregularities,butdoesnotindicatea
failure.
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Somepixelsmayhavedisplaydefects(Itcan
notlightoralwaysstaylit).
Incoldplaces,theimagemayappearwithadashorthe
poorimage,butthisdoesnotindicatefailure,theequipmentwillreturn
tonormaloncethetemperaturerises.
Donotleaveastillimageforalongtime,thiscan
causedamagetothedisplay.
Theimagemayappearindifferentshadesofcolorbetweenthe
MonitorandtheReferenceMonitor.
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(1)Monitor
Displaysthefluoroscopicimagesduringfluoroscopyimages
Radiographic,maintaininglastimage(LIH)andrevisedimages.
(2)ReferenceMonitor
Displaysreferenceimages.
Itallowsrecordingpatientinformationandmakevariousadjustmentsto
imaging(fluoroscopy,radiography),postprocessing,etc.
Inadditiontooperationswiththemouseandkeyboard,youcanalsoperform
operationswiththetouchpanel(optional).
(3)MonitorPositionAdjustment
Usedtomoveupordowntoadjustthepositionof
monitor.
(4)Keyboard
Locationofthekeyboard,mouse,etc.
(5)SystemSwitch
Turnonoroffthesystem.
(6)IndicatorIrradiation
TheindicatedisilluminatedduringradiationbyXrays.
(7)ArmSupportAssistant
Fixedthedisplaypositionintheverticaldirection.Toadjustthisposition,
WemustfirstreleasethelockSupportFlyArm.
(8)PowerSwitch
Turnonoroffthesystem.
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2.2MainPanel
2.2.1OpescopeActivefunctionofeachkey
Figure2.8MainPanelOpescopeActive
Legendand
1Releasingtheexposurerestrictionofxrayspresstheswitch
exposuretoxraysorthepedaltoreleasetherestrictionofxraysto
fluoroscopyandradiography.
2Exposuretoxray(fluoroscopy)pressthiskeytostart
exposuretofluoroscopy.
3filmradiographymodepressthiskeytomakearecord
photoonthefilm.TheLEDwilllightup.
4Optionaldigitalsubtractionsystem
5FilterSelectionpressthiskeytoselectthefilter.Thefilter
selectedwillchangeeverytimethekeyispressed..
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Filter1(fine):LeftLEDlights
Filter2(medium):TherightLEDlights
Filter3(thick):ThetwoLEDswilllight
Noadditionalfilter:BothLEDsareoff
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9APRThecorrespondingLEDwilllighttheAPR.
10IBSpressthiskeytoturnon/offtheIBSfunction(setfunction
Automaticbrightness)
11SelectingthesizeofthemagnificationIIpressthiskeyto
selectthesizeoftheIILEDremainslitwhenmagnification
the6inchfieldisselected,andturnsoffwhenthe9field
inchisselected.
12LaserPointerLEDwillremainlitwhilethelaserpointer
Itisbeingused.
13continuousfluoroscopyratedisplay/PulsedHighQuality
14/15SelectionFluoromodetopressthesekeystoselectthe
Fluoromode.TheLEDslightupasfollows:
Highquality(highqualitymode):
"HQ"light.
Lowdoses(lowdosemode)
"LD"willlightup.
Normal(normalmode)
AllLEDswilllightup.
16TemperaturegeneratorxrayIndicatesthetemperatureofthegenerator
Xray.asthetemperaturebecomeshigh,thelampcolorchangesfromgreento
orangeandred.Whentheindicationisorangeorred,itmeans
thatfluoroscopyisdisabledassoonasthetemperatureofthexraygenerator
istall.
17NumberDisplayindicatesthecurrentmemoryimagenumber.if
noimageisdisplayedwillnotshowanynumber.
18MemoryAddsanimageinmemory
19SelectionPresstochangetheimagedisplayedmemory.
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20PrinteroutputPrintsimages(onlyeffectivewhena
printerisinstalled)
21Exchange/displaysthetubevoltageIndicatesthetubevoltage.Press[]/[+]
tomanuallychangethetensionadjustment.However,notethatyoucannot
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changingthetubevoltagewhentheIBSfunction(Auto)ison
22CurrentDisplayofthexraytubeToedit/displaythecurrent
InFluoromode:
Thetubecurrentisautomaticallydisplayedinaccordancewiththefluoromode.THE
Currentcurrentcannotbechangedmanually.
Intheradiographicfilmmode:
Indicatestheproductofthetubecurrenttime.Press[]/[+]tochangethis
time.
23CumulativefluoroscopyTime/displayradiographytime:
InFluoromode:
Itshowsthecumulativetimefluoroscopy.theminutesandsecondsaredisplayed.
Whenthetimeexceeds99minutesand59seconds,oneminuteisdisplayed.
Inradiographicfilmmode:
Beforeradiography,displaystheadjustedtimeradiographic
AftertheXray,radiographicdisplaysthemeasuredtime
24Displayoffluoroscopywristband,Camera,collimatorangle,
Errordisplay:
Normallydisplaystherangeofpulsedfluoroscopy(fpslights)
Duringcontinuousfluoroscopy,nothingisdisplayed(fpsoff)
Whenthecameraoperationandthecollimator(ie,theswitchesonthepanel
sidebeingoperated),thecurrentangleisdisplayedflashing.
Ifanerroroccurs,anerrorcodeisdisplayed.
25Resetpressthiskeytoresetadisplayederror.Holding
thiskeyforonesecondthefollowinginformationwillbereset:
cumulativefluoroscopytime
Registrationinformationinthekey
MemoryImage
26APRRegistrationpressthiskeytoregistertheAPR.
27FluoroModeDisplaywilllightthewayFluoro
28ErrorDisplaystayonafteranerrorisactive
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29Standbydisplaylightwhiletheirradiationofxraysispossible
30DisplayexposureXraysduringirradiationilluminatexray
31AlarmResetTimerfluoroscopyFortimerfluoroscopy
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2.2.2OpescopeFullFunctionofeachkey
Figure2.9MainPanelOpescopeFull
Subtitle:
1releasebuttonlockdisplayxrays:pressto
releasethelockexposurexrays.
2Exposurekeyxray:presstostartfluoroscopy.
3Alarmresetbuttonoffluoroscopictimer:fortheaudiblealarm
timerfluoroscopy.
4Imageexchangekey(optional):Thiskeyisusedtochangethepicture
oroperationscreen.
5Automaticadjustmentkeywindow/level:automaticallyadjuststhecontrastand
thebrightnessoftheradiographicimage.
6windowadjustmentbutton:adjuststhecontrastoftheimage.
7leveladjustmentbutton:adjuststhebrightnessoftheimage.
8depthadjustmentbutton:adjuststhedepthoftheimage.
9examcompletionkey:presstoendtheexam.
10MENUbutton:pressthisbuttontoadjustthemenu.
11Multipurposekey:thiskeyisusedinconjunctionwiththedisplayedbutton
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onthescreeninimageprocessing.
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2.2.2.1FullOpescopeLCDDisplay
Atouchscreenisbuiltintotheunit,allowing
operationdirectlybypressingthebuttonsonthescreen.
Thebuttonsdisplayeddifferaccordingtothescreen.Thebasicscreenappears
below:
1DisplayoffluoroscopymodeLitinfluoroscopymode.
2IBS(imagebrightnessstabilizationfunction)Pressthiskey
toenableIBSfunction.ThekeyislitwhentheIBSfunctionison.
3voltageoftheXraytubeIndicatesthetubevoltage.Theadjustmentvariesfrom40to
110kV.Press[+]/[]tochangethisvaluemanually.
4currentoftheXraytubeInthefluoroscopymode,thetubecurrent
Itisautomaticallyselected.Thisvaluecannotbechangedmanually.
5SystemStatusIndicatorDisplaysthestatusofthesystem.
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Whenfluoroscopicradiographyispossible.
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WhenthereisthepresenceofXrayradiation.
WhenthetubeXrayisinhightemperatureorhighhumidity.
6FluoroscopyAccumulatedTimeInorderfluoroscopytime
accumulatedfluoroscopyisindicatedhere.Whenthetimeexceeds99minutes59
seconds,thedisplaychangestominuteunitsonly.
7FilterUsedtoselectthefilter.Eachtimethiskeyis
Pressthefilterchanges.Thefiltersequenceis1Filter<Filter2<Filter3.
8MoviemodeRadiographicPressthiskeywhenyouwanttoperform
rayperfilm.Thescreenradiographappears.
9XraytubetemperatureIndicatesthetemperatureoftheXraytube.
whenthetemperatureincreases,thedisplaybarextends.
10DisplaymodeDisplaysthedisplaymodedialog.Thisallowsmenu
selectthetypeofdisplay,thumbnaildisplay,performing
Zoomoperations,reversethepolarityoftheimage,reverseimage
vertically,orremasktheimage.
11SendREFPresstosendtheimagedisplayedonthemonitortothe
referencemonitor.
12SavefluoroscopicimageSavethefluoroscopicimagedisplayedon
monitor(includingloops)ontheharddrive.
13VideoPrintingPresstoprinttheimagedisplayedonthescreen
monitorinanimageprinter.(Onlyappearswhentheprinter
specifiedisconnected.)
14SelectionAPRDisplaystheAPRscreen.
15IntensifiedimagefieldsizeselectionPressto
select16cmor23cmasintensifierfieldsize
Image.
16LoopFluoroscopyUsedtoregisterafluoroscopicimage
inmemory(Maximum100imagesbeforefinalizingfluoroscopy).Stay
litwhenthefunctionison.
17LaserPointeronoroffthefunction.
18ProductDosebyAreaIndicatesthedoseperareadetectedbyasensor.
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2.3Sidepanel
2.3.1lockswitcharmC
UsedtolockorreleasethearmC.
Figure2.10lockswitcharmC
1slipmovementofthearmC
LEDon:ThelockarmCisreleased
LEDoff:ThearmCislocked
2RotationalmovementofthearmC
3lateralandposteriorslidingmovementofthearmC
4longitudinalmovementofthearmC
2.3.2ControlKeys
Figure2.11ControlKeys
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1/2MemoryKeyusedtostoretheconditionsoffluoroscopyand
thecollimatorsettings
3Open/Closethecollimatoroctagonal
4Open/Closetheparallelcollimator
5Rotatestheparallelcollimator
Figure2.12Collimatorsoctagonalandparallel
6FastFoodholdingthiskeywhilepressingthe
rotationoftheparallelcollimatororcamerarotationspeedinthese
operationsincreases
7Rotationcamerausedtorotatethecamera
8Monitorimagereversalusedtoreversetheimagedisplayedon
themonitor.
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Chapter3
Basicoperation
Thischapterexplainsthebasicproceduresforusingthesystem.
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3.1BASICOPERATIONS
PoweringOn/Offpower
Toavoidproblemswiththesystemwhileexaminingapatient,
alwaysmakeaninspectiontocheckthateverythingisinaccordancewiththe
specifications.
3.1.1ConnectingtheUnits
1Unrollthesignalcableonthebackofthecarsupport
monitors.
2Connectthesignalcabletothemainunittothispositiontheconnectorand
rotateitclockwiseturnasfig.below.
Figure3.1Connector
3Connectthepowercordatthebackofthecarsupport
monitorsthelocaloutlet,confirmingthattheunitvoltageiscompatiblewith
makingselected.
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Page53
3.1.2)Connecttheequipment
1Setthepowerswitchonthebackofthemonitorstandto"|"
[switchedon].
Figure3.2On/offswitch
3
2Pressthefrontofthekeymonitorstand.
AllLEDsonthemainpanelandsidepanelwilllightupfor
about1second.
Initializationofthecollimator,camerarotation,etc.,willcontinuefor
approximately30seconds.Duringthistime,thekey"init"
lightsinthepulseratedisplayedonthemainpanel.
Whenyouturnofftheequipmentandneedtoconnectagain,waita
10minuteinterval.
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3.2Turningthepoweroff
3.2.1ActiveOpescope
Afteryoufinishusingthemachineperformthefinalinspectionandfilethe
results.
1MakesurethearmCisinthehome.
Theinitialpositionisoneatallscalesrecordzero.
Figure3.3StartPositionArmCOpescopeActive
3
2Pressthekeyto[OFF].
3Settheswitchonthebackofthemonitorstandto[off].
4Disconnectthemainpowercable.
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3.2.2FullOpescope
strictlyfollowtheprocedurebelowtoturnoffthe
equipment.
OnlypresstheOFFbuttononthebackofthemonitorstand(s)or
unplugthepowercordafterthecompletionoftheprocess
systemshutdown.Butthesystemandthedataislost.
Also,iftheOFFkeyispressedduringthedatatransfer
imagetoamedia(CDR),theimagedatawillbelost.
1MakesurethearmCisinthehome.
Theinitialpositionisoneatallscalesrecordzero.
Figure3.4StartPositionArmCFullOpescope
2Proceedwiththeshutdownoperationoftheequipmentthroughthemonitor
ofreference.
Pressthefunctionkey
Choosefunction
todisplaythefunctionsonthemonitor.
.
Thepatient'sfilewillbeclosedandaconfirmationdialogbox
askingifyouwanttoexittheapplicationisdisplayed,confirm
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clicking"Yes".
3Makesurethegreenlightontheswitchfromthefrontofthecart
monitor(s)off.
4Pressthepowerbutton(OFF)onthebackofthecart
monitor(s)
Figure3.5PowerButtonFullOpescope
5Unplugthepowercord
3.3POSITIONING(ARMCOPERATION)
PlacetheArmCintherequiredpositionfluoroscopy/radiography.
Figure3.6Locationofthepointwherethefingerscangetcaught
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Beawareofthedangerofshockorholdanypartofthebodyto
equipment.
WhenoperatingthearmC,carefulnottobumptheequipmentdevices
peripherals.ManipulatethearmCbythehandles,itmayhappenaccidents
howtoholdyourfingerstotheequipment.
3
Donotplaceperipheraldeviceswithintherangeofmovement
system.
Ifperipheraldevicessuchasthemonitorstandisplacedwithinthearea
showninFigure15,thereisadangerofcollisionorcontact.
Figure3.7DriveRange
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1PressthearmCofthebeaminthedirectionyouwanttomove.
TheLEDwilllightandthecorrespondingbrakeisreleased.
2Holdingthehandles,movethearmCfortheposition.
3WhenyoufinishpositioningthearmC,engagethelock.
TheLEDwillturnoffandthearmCislocked.
4Makesurethebrakeisapplied.
Evenwhenthebrakeisactivated,youcanmovetheframein
oppositiontothebrakebyapplyingaforcegreaterthan10kgf.Thisisameasure
toenabletheoperationofallpartsofthesystemevenin
criticalsituationasoverhead.
Ifmorethanoneminutepassedwithoutanyoperationintheunlockedstate
(LED),thesystemautomaticallyreturnstothelockedstate(LED
wipedout).
3.3.1VerticalmovementofarmC
Figure3.8VerticalmovementofarmC
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3.3.2longitudinalmovementandlateralarmC
Figure3.9longitudinalandlateralmovementsofthearmC
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3.3.3axialrotationalmovementofthearmC
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Figure3.10axialrotationalmovementofthearmC
3.3.4rotationalmovementofthearmC
Figure3:11rotationalmovementofthearmC
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3.3.5scales
Everymovementfeaturesascalethatyoucanseeasaguide
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duringthemove.Notethattherangeofcolormatchesthecolorkey
armClock.
ThezerooneachscaleistheinitialpositionofthearmC.
Figure3.12Scale
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3.3.6GauntletofIIControl(Optional)
TherearetwokeysonthehandleII
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Whilethiskeyispressed,thelockonthereturnslip
sideandarmClongitudinalmovementarereleasedandtheLEDsbelow
Theywillbeilluminated.
Figure3.13lockkeysonthehandleII
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3.4SELECTINGAPR
3.4.1OPESCOPEASSETS
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1Pressthe[APR]key.TheLEDwilllightup.
Thereare6typesofRPAaccordingtotheobservationposition.Theconditions
greatfluoroscopyandcamerarotationpositionsaresetintheAPR.
TheAPRsaresetinthesystematthefactory,butyoucanchangeto
Accordingtooptimizeitsuse.
Figure3.14APRKey(OpescopeActive)
T
LegendPositionNote:
1HeadHead
2AbdomenAbdomen
3Upperarm,handjoints,fingers,shoulderjoints,etc.upperarm,gaskets
hand,fingers,jointsofshoulders,etc.
4LegsLegs
5/6UsersettingsUsersettings
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3.4.2OPESCOPEFULL
AfterregisteringthepatientorpresstheAPRselectionbuttononthe
mainpanel,itwillbedisplayed.
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1Check[APR]
TochangetheAPR,presstheselectkey.
TheselectedAPRwillappearhighlightedonthemonitor.
2Press[OK]
Theprimaryscreenisdisplayed.
Figure3.15APRKey(OpescopeFull)
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3.4.2.1ChangingtheAPRscreen
Theywillbeshownsixbuttons[APR]simultaneouslyonthescreen
APR.Press[next]togotothenextpage.It'spossible
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viewupto12APRs.
Figure3.16APRSelectionScreen
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3.4.2.2ChangingthecombinationoffluoroscopyandacquisitionAPRAPR
1Presstheacquisition/fluoroscopyAPR.
Theselectionoptionsaredisplayed.
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Figure3.17Screenselectionofacquisition/fluoroscopyAPR
2ChangetheselectionoffluoroscopyAPRandAPRacquisitionandpress[closes].
APRselectionscreenwillberedisplayed.
FluoroscopyAPRandAPRacquisitionwillbeindicatedonthedisplay.
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Figure3.18Screentoclosethewindow
3Press[OK]
Theprimaryscreenisdisplayed.
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3.5FLUOROSCOPY
3.5.1OPESCOPEASSETS
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Figure3.19resetbutton
Whenfluoroscopyoptionequipmentistestedbeforestart
cycletests,youneedtoreset(delete)thefluoroscopytime
totalized.
Pressthe[reset]buttonforabout1second.
1Press[releasingthexrayexposurerestriction].
TheLEDlights[releasingthexrayexposurerestriction].
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Figure3.20Freeingexposurerestrictionofxrays
Thexrayradiationisonlypossiblewhenthekey
ordertopreventfaultyoperation,theLEDisoffwhenthe
poweristurnedon.WhiletheLEDisoff,youcannot
initiatingradiation.
ison.In
3
2Checktheconditionoffluoroscopy.Thevariablesareset
automaticallyaccordingtotheselectedAPR,butyoucanchangethe
manuallyadjustments.
Figure3:21Checkingtheconditionsoffluoroscopy
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3Pressthepedalorpress[exposurexray(fluoroscopy)].
Xraysareirradiatedwhilethepedalispressedorwhile
keyispressed.
Theradiationindicatorlights.
Thefluoroscopicimageisdisplayedonthemonitor.
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Figure3.22Startfluoroscopy(exposurekeyxray)
Whenthesettingsoffluoroscopyconditions,orcollimator,orrotation
camera,areexchangedmanually,theLEDwillflashAPR.
3
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changingthe
soFluoro
HQmodetheLEDwilllight.
InLDmode,theLEDwilllight
Inordinarywordstate,pressthebuttonthatislitto
turnofftheLED
HQ:HighQuality(highqualitymode)
Theareaisirradiatedwithahigherdoseofxraystogenerate
Highqualityimagesinpatientsdifficulttopenetratethe
Xray.
LD:LowDose(lowdosemode)
Thelowdosexraysisusedtoreducetheamount
irradiatedxrays.
Normal(normalmode)
Theirradiateddoseisstandard.
Swapping
inbetween
fluoroscopy
pulsedand
Pressthekeys
toswitchbetweenfluoroscopy
continuousorpulsedfluoroscopy.Forpulsedfluoroscopy,the
Pulserateisdisplayedwithanumericalvalue.
Tobecontinued
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fluoroscopy
tobecontinued
Press
pulsed
Calling/
disconnectingthe
functionIBS
(Function
stabilization
Shining
image)
TheLEDwillremainlitwhiletheIBSfunction
isoff.
WhenIBSfunctionisconnected,thedoseofxraysis
automaticallyadjustedaccordingtothearea.
Changingthe
tubevoltage
Increasesvoltage
Decreasestension
OnlyvalidwhileIBSisOff
Changebypressingthekeys[+]/[].
Exchanging
filter
Thefilterischangedeverytimethekey
Filter1(fine):LeftLEDlights.
Filter2(medium):TherightLEDlightsup.
Filter3(thick):BothLEDslightup.
Noadditionalfilter:BothLEDsareoff
ispressed.
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Selecting
thesizeofthe
magnification
II
Press
toselectthesizeof
magnificationII
Whenthefield16cm(6inches)isused,theLED
remainon.Whenthepitchof23cm(9inches)is
used,theLEDisoff(Validfor9Activemodels"
andFull.
ForcontinuousfluoroscopyinHQmode,thehighdoseisused.Forthisreason,a
warningtoneissoundedcontinuously.
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Ifthefluoroscopytimeisexceeded,thealarmwillsound.Thealarmcanbe
stoppedbypressing
Youcancontinuewithfluoroscopyevenwhenthefluoroscopytime
setisexceededandthealarmsounding.However,thelimitforfluoroscopy
Continuousis10minutes.Asthislimitisreached,theexposureofxraysis
automaticallystop.Tocontinueafterthispointfluoroscopy
releasetheleftpedalandpressitagain(orreleasethebutton
[Exposurexray(fluoroscopy)]andpressitagain).
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3.5.2OPESCOPEFULL
1Checkthefluoroscopicconditions.
Thefluoroscopicconditionsareautomaticallyadjustedaccordingtothe
APRselection.
Youcanchangetheseconditionsmanually.
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Figure3:23Mainscreenoffluoroscopicconditions
2Ifthekeyisoff,pressit.
Tomaketheirradiationbuttonshouldbeon.
Figure3.24exposurelockreleasebuttonxray
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3Presstheleftpedal.
Irradiationforfluoroscopystarts.
Duringirradiation,thekeywillremainonthemainpanel.
Whilexraysareirradiated,theirradiationindicatorislitin
Standmonitor.Thefluoroscopicimageisdisplayedonthemonitor.
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Figure3.25Exposurebuttonxray(fluoroscopy)
3.5.2.1Changingthefluoroscopicconditions1(fluoroscopyprogram)
1Press[fluoroscopyProgram].
Fluoroscopyprogramselectionscreenisdisplayed.
Figure3.26fluoroscopyProgram
2Selectthefluoroscopyprogram.
Theselectedbuttonishighlightedandthewindowcloses.
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Figure3.27fluoroscopyProgram
[Next]fluoroscopyprogramselectionscreenshowsfour
fluoroscopyprogramsonapage.Press[next]todisplaythe
nextpagefluoroscopyprogramselectionscreen.
3.5.2.2Changingconditionsfluoroscopy2(fluoroscopymode)
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1Press[fluoroscopymode].
Theselectedbuttonwillappearprominently.
[HQ]HighQuality(highqualitymode)Theareaisirradiatedwithhigher
dosexraystogeneratehighqualityimagesinpatientsdifficult
penetrationofXrays.
[N]:Normal(normalmode)thestandarddoseisirradiated.
[LD]Lowdose(lowdosemode)lowdosexraysisradiated.
Figure3.28fluoroscopymode
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3.5.2.3Changingthefluoroscopicconditions3(pulserate)
1Press[pulserate]
Pulserateselectionscreenisdisplayed.
Figure3:29Pulserate
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2Selectthefluoroscopicpulserate.
Select[CONTINUOUS]forcontinuousfluoroscopy.Whenselectingany
anotherbutton,pulsedfluoroscopyisperformedandthepulseratewillbe
changesinrelationtotheselectedvalue.
Ifyouprefernottochange,press[closes].
Figure3.30PulseRateSelection
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3.6CAMERAROTATION,REVERSEIMAGE,
COLLIMATOROPERATION
Figure3.31Viewofthecontrolbuttons
3.6.1CameraRotationKey
camerarotation/image
Pressingthisbuttonthecamera/imagerotates.Duringfluoroscopy,theimage
displayedtheexposedareaalsorotatesaccordingtotherotationofthecamera.ITIS
possibletoincreasethespeedofrotationofthecameraholdingthekey
fastfoodwhilepressingthecamerakeyrotation.
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Whileholdingthecamerarotationkey,therotationangle
thecameraisdisplayedinthemainpanel.(OpescopeActive)
Figure3.32Screenrotationangle(OpescopeActive)
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3.6.2ImagebuttonReverse
reverseimage
Pressingthisbuttonfluoroscopicimagereversed.
1.ReverseH(horizontalinversion)
2.InversionV(verticalflip)
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3.6.3OperationKeyofCollimator
Pressthesebuttonstoopen/closeandrotatethecollimatorandoctagonal
parallelcollimator.
Whilepressingthebutton,theangleofrotationisindicated
onthescreeninthemainpanel.Theparallelcollimatorallowsrotations
repeated.
Figure3:33Collimatoroctagonalandparallel
1.Open/Closethecollimatoroctagonal
Pressingthisbuttonopensthecollimatoroctagonal.
Pressingthisbuttontheoctagonalcollimatorcloses.
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2.Open/Closeparallelcollimator
Pressingthisbuttonopensthecollimatorparallel.
Pressingthisbuttonclosestheparallelcollimator.
3.Rotationoftheparallelcollimator
Pressingthisbuttontheparallelcollimatorrotatesin
schedule.
Pressingthisbuttontheparallelcollimatorrotatescounterclockwise
schedule.
4.Speed
Pressingthiskeytogetherwiththekeyrotation
theparallelcollimatorspeedisincreased
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3.7FUNCTIONOFMEMORYFRAME
OPESCOPEASSETS
Youcantemporarilystoreupto8imagescurrentlydisplayed.
Settingonamonitor(standard)
Memoryimagesframearedisplayedonthemonitor.Note,however,
thatduringthefluoroscopicimagefluoroscopyappears,butthen
fluoroscopytheLIHimageisdisplayed.Youcanswitchtodisplaythe
framememory,performingtheoperationsoftheframememory.
Configurationoftwomonitors(usedonlyasthesecond
monitoroptionalisselected)
Theframememoryoftheimageisalwaysdisplayedonthereferencemonitor.
storingimages
Press
[Framememory].
Thecurrentimageisdisplayedonthemonitorisstored,andthenumberof
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memoryisdisplayed.
Imageselection
Press
[Selectionframe].
Pressingthisbutton
theframenumberincreases.
Pressingthisbutton
framenumberdecreases.
Theexchangeimagedisplayedwhenthememorynumberischanged.
Memorynumber1:latestimageinmemory
MemoryNumber8:olderpictureinmemory
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Whenthenumberofpayrollimagestotheframememoriesexceeds
8,thenewimageisstoredasnumber[1]andtheimage
storedinthenumber[8]iserased.
Whenthesystemisturnedoff,thestoredimageisdeleted.
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3.8RADIOGRAPHY(CRRadiographicorMovie)
OPESCOPEASSETS
WhenRadiographicMoviemodeisselected,thecollimatoroctagonal
Itwillautomaticallybefullyopened.Ifnecessaryadjustthe
collimatorparallel,makethesettingonthesidepanel.
Setthetapeandtaketheradiograph.
[FilmradiographymodeorCR].
1Press
2SetthekVandmAsvaluesbypressing[+]/[].
3Releasetherightpedalorpressthehandbutton(optional).
StartpreparationsforXray.
The[ofthescreen]keywilldeletetemporarily.
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Whenpreparationsforexposurearecompleted,the
keywillreturn
4Whenusingthepedal,holdthepedal.
Whenusingthehandcontrol(optional),pressthecontrolforthesecond
level.
Thexrayirradiationstarts.
Duringirradiation,theindicatorlightirradiationwillbe
on.
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Keepthepedalorhandcontrol(optional)Pressed
FullXrayradiation.Ifthecommandsarereleased,the
radiationXrayswillendprematurely.
Ifthesystemhasthehandcontrol(optional),youcannottake
Xrayswiththerightpedal.
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Figure3:34FilmRadiography(OpescopeActive)
83
Page84
DependingontheXrayparameters,onemaybenecessary
waitingtimeafterradiography.Inthiscase,theword"COOL"willbe
displayed,alongwiththewaitingtime.Duringthistimewillnot
possiblexrayfluoroscopybutyes.
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Figure3.35DisplayCOOLandDisplayTimeout
84
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OPESCOPEFULL
1Placethesupporttape
2Press[radiographymodefilm].
Thekeywilllight.
Figure3:36radiographymodeinmovie
3Press[+]/[]toadjustthetubevoltage(kV)andtheproductof
timextubecurrent(mAs).
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Figure3:37radiographymodeinmovie
85
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4Releasetherightpedal.Alternatively,pressthehandcontrol
(Optional)tothefirstlevel.
Figure3:38RadiographyinFilm
5Continuereleasingtherightpedal,orpressthehandcontrolto
thesecondlevel.
Thexraysareirradiated.Duringirradiation,thecorresponding
indicator(onthemonitorstand)willremainon.
Keepthepedalorhandcontrol(optional)Pressed
FullXrayradiation.Ifthecommandsarereleased,the
radiationXrayswillendprematurely.
6Press[radiographymodefilm]
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ThekeygoesoutandtheXrayiscompleted.Theprimaryscreenisre
displayed.
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3.9USEFULFUNCTIONS
3.9.1MemoryKey
Storetherotationalpositionofthecamera,collimatorposition,thefactor
loadingandotherinformation.
Thisoperationisnotpossibleduringfluoroscopy.
Informationstoredwiththisfunctioncanbeerased
pressingthebutton.
Thefollowingparameterscanbestored.
Camerarotationalposition
Positionopen/closeandrotationalangleofthecollimators
ImageInversion
FluoroMode
Pulserate
Filter
Switchingon/offIBS(imagebrightnessstabilizationfunction)
Tubevoltage(IBSisconnectedwhenthetubevoltagestarts)
magnificationsizeII
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Figure3:39MemoryKey
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1Holdthebutton(forabout1second).
Thecurrentconditionsarestored.
WhenthestorageendtheLED.
Ifthestoredconditionschange,theLEDwillflash,indicatinga
incompatibilitybetweenthecurrentconditionsandstoredconditions
therelevantmemorykey.
2Pressthememorykeythatisflashing.
Theconditionsstoredinthememorykeywillbecalled.
Atthesametime,theLEDstopsblinkingandstayson
continuously.
differentusesforthetwomemorykeys
1HoldthememorybuttonAforabout1second.
ThecurrentconditionswillbestoredinmemorykeyA.
WhenthestoreisfulltheLEDwillflash.
2Modifytheconditionsasthecamerarotationalpositionmode
Fluoro.
MemorykeyAflashes.
3PresstheBbuttonbriefly.
ThemodifiedconditionswillbesavedinthememorykeyB.
Whenstorageiscomplete,theLEDwillflash.
TheLEDAoff.
4PressthememorykeyA.
TheAbuttonwilllight,andthesystemwillreturntothesavedconditionsin
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A.memorykey
TheLEDBoff.
5PressthememorykeyB.
TheLEDBlightsupandthesystemwilladopttheconditions
savedinthememorykeyB.
TheLEDAoff.
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3.9.2ChangingtheAPRadjustment(OpescopeActive)
YoucanchangetheAPRsettings.
1ChangetheconditionsasFluoromodesettingsandconditions
Xray.
Thefollowinginformationmaybelogged.
Camerarotationalposition
Positionopens/closesthecollimatorandrotationangle
ImageInversion
fluoroscopymode
Pulserate
Filter
On/OffIBS(imagebrightnessstabilizationfunction).
Tubevoltage(asIBSisconnected,thetubevoltage
starts)
magnificationsizeII
2Press[APR]andthekeyatthesametime.
TheadjustmentintheAPRwhosebuttonsarepressedwillbewritten.
Whenregistrationiscomplete,analarmwillsound.
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Figure3:40RegisteringthesettingsmodifiedinAPR
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3.9.3Changingthepresettimerinfluoroscopy
Youcanadjustthetimetothepresettimerinfluoroscopy.
Screenwithpresetvalueofthetimer
Figure3:41Changingthepresettimerfluoroscopy
1InFluoromode,pressthe[changingthetimerpre
adjustedfluoroscopy].
Thevalueofthetimersetwillbedisplayedflashing.
2Eachtimeyoupressthebuttonwhilethedisplayisflashing,the
timervaluewillbeincreasedby30seconds.
Youcanadjustthevalueofthetimerasfollows:
3thecourseof3secondsaftertheoperationinstep2,thescreenreturns
thecumulativedisplaytimefluoroscopy.
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3:10DIGITALRADIOGRAPHY
OPESCOPEFULL
Thedigitalradiographyconditionsareautomaticallyadjusted
basedonfluoroscopicconditions.Forthisreason,beforetakingthe
Xray,youmustconnecttheIBSfunctionandperformfluoroscopyto
thefluoroscopicimageisstabilized.
1Checktheradiographicconditions.
Figure3:42ScreenRadiography
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Thesefunctionsareonlydisplayedwhenatechniquethatinvolves
serialradiography,suchasDSAorserialisselected.
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2Releasetheleftpedal.
Irradiationstartsandtheradiographicimageappears
onthemonitor.
Figure3:43Gettingradiography
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Changingtheradiographicprogram(acquisitionprogram)
Changesmadethroughthemainpanelaretemporary.
1Press[selectionacquisitionprogram]
Theacquisitionscreenappears.
Figure3:44Selectionacquisitionprogram
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Page94
2Selecttheacquisitionprogram.
Thebuttonishighlightedandthewindowcloses.
Figure3:45Selectionacquisitionprogram
[Next]Theselectionwindowacquisitionprogramshows
fouracquisitionprogramsonapage.Press[next]
toviewthenextprogramselectionpage
acquisition.
Ifyoudonotwanttochangetheselectionoftheacquisitionprogram,performthe
operationsdescribedbelowtoreturntothebasicscreenwithoutchangingthe
acquisitionprogram.
Press[Close]
StartAcquisition
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Page95
Changingtheacquisitionrate
1Press[acquisitionrate]
Thewindowwiththeselectionoftheacquisitionrateisdisplayed.
Figure3:46ChangeofAcquisitionRate1
[Acquisitionrate]isonlydisplayedwhenatechniqueinvolving
continuousradiographyas"serial"or"DSA"isused.
Ifaprogramsequencehasanacquisitionrateexceeding5
fps,themodeishighspeedandtubevoltageandthequalityof
imagecanbechanged.
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2Selecttheacquisitionrate
Thebuttonwillbehighlightedandtheselectionwindowoftheacquisitionrate
Itwillbeclosed.
Ifyouwanttokeeptherateofpurchase,pressthe[close]
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96
Page97
Changingtheprogramsequence
Press[sequence]intheselectionwindowoftheacquisitionrateandmake
selection.Youwillneedtoadjusttheprogramsequenceonthemonitor.if
thereisnosetsequence,the[detailsdetails]not
appears.
1Press[details]
Theprogramsequenceselectionwindowappears.
Figure3:49acquisitionsequencedetails
2Press[]/[]toselecttheprogramsequence.
Theselectedprogramsequenceisdisplayed.
Figure3:50Selectionofprogramsequence
97
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Page98
3Press[closes]
Theprogramsequenceselectionwindowisclosed.
ProgramSequenceDetails
Figure3:51ProgramSequencedetails.
Thefollowingdetailsscreenshowsdetailsoftheprogram
sequenceofselectedprograms.Itdisplays5levelsrecorded
acquisitionrateandtime.
98
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Page99
3:11Tweaking
FullOpescope
Youcancalibratethetouchpanel,adjustthesound,setthetimer
Fluoroscopy,checkthesettingsstoredinmemory.
Makesurethedisplayisturnedoffbeforetheoperation.
Thechangesthataremadetotheunitwillremainthesameeffective
themachineisrestarted.
1Pression[Menu]
TheSystemSetupmenuscreenappears.
Figure3:52SystemSetupMenuScreen
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Page100
Chapter4
Troubleshooting
Thischapterexplainsthecorrectiveactionstobetakeniftheequipment
presentproblem.
100
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4.1Respondingtoproblems
Whenaproblemoccurswiththesystem,followtheinstructions
flowchartfollowingappears:
Ifyouhaveanyquestionsonprocedure,contacttechnicalassistance
authorized.
Ifyounoticeanyproblemswiththesystem,stopuseimmediately.
Repairsandmaintenanceshouldbecarriedoutonlybytechnicaland/or
authorizedservice.
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FluoxogramaprocedureConcealer
Occurrenceofproblem
Ifamessage
appears,
seethelistof
errors.
No
Got
solvethe
problem?
Yes
END
Telephoneassistance
authorizedservice.
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4.2Listoferrors
Ifanerroroccurs,thekeywilllightupdependingonthenatureof
errorandacodewillbedisplayedontheerrorscreen.
Code
Er1to9
Er1019
Er20to29
Er30to39
Er40to49
Er50to59
Er60to99
HEAT
Message
CPUerror
sourceoferrorofinternalenergy
controlcircuiterror
Errorinthehighvoltagegenerationcontrolsystem
Errorsassociatedwithtemperaturedetectionand
communications
Errorinmechanicalcontrolsystemcollimator
Errorsassociatedwiththesystem
Hightemperaturethroughoutthexraytube
Whilethebuttonisflashing,youcanperformfluoroscopy
radiograph.
Whilethekeyislitcontinuously,youcannot
performfluoroscopyandradiography.
Whenthexraytubeassemblyattainsahightemperature,
HEATcodeappears,andyoucannotperformradiographyand
fluoroscopy.Whenthetemperaturelowers,themessageis
automaticallyerasedandthenyoucanperformfluoroscopy
radiograph.
Figure4.1AssetOpescopeerrorscreen
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Figure4.2OpescopeFullErrorScreen
4.3OperatingChange
Intheeventofoperatingchange,turnoffthemachineandenter
contactyourdealer.
ShimadzuofBrazilLtda
Address:MarquesAvenueStVincent,1771SP
Tel.:(11)21341688/Fax:(11)36112209
email:webmaster@shimadzu.com.br
website:www.shimadzu.com.br
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Chapter5
MaintenanceandInspection
Thischapterexplainsthedailyandperiodicinspections.Inspectionsshouldbe
heldastomaintainequipmentperformanceandensure
safety.
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5.1MaintenanceandInspections
Ourcompletequalitycontrolandinspectionprocedures
ensurethatthesystemistransportedinoptimalconditions.For
maintainoptimalconditions,weneedtoimplementandmaintain
inspection.
Themaintenanceandinspectionsforthesystemareclassifiedas
followbelow:
Typeofmaintenance/
inspection
startingthe
inspections inspections
daily
finalizingthe
inspections
Cleaninganddisinfection
periodicinspections
implementedby
Operatorormanager
equipment
Operatorormanager
equipment
Operatorormanager
equipment
Technicalassistance
authorized
Interval
Daily
Daily
Whennecessary
Every6months
5.2Dailyinspections
Dailychecksincludethebeginningandendofinspections.
Dailyinspectionsarenecessarytomaintainthesystemforalong
period.
Checkallinspectionsandcorrectiveactionshavebeencompletedbefore
tousethesystem.
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ReferringtoFig.
5.3Cleaninganddisinfection
Youwillneedtocleananddisinfectthesystem.
Cleaninganddisinfectionareveryimportanttoensurethatthe
systemcanbeusedsafely.Youwillneedtofollowthemethods
indicatedbythemanufacturer
1Makesurethatthesystem'smainswitchisturnedoffanddisconnectthe
maincable.
Unplugthemaincablebeforeyoustartcleaning.
Youmustdisconnectthesystemfrommainsbeforestarting
cleaninganddisinfection.
Turnoffthesystembeforedisconnectingthemaincable.
Otherwisethereisariskofelectricshockandleakagecurrent.
2Performcleaninganddisinfection.
Cleantheoutersurfaceofthesystemwithadampcloth
glutaraldehydeina2%solution.
Donotusewateronthesystem.
Cleanthesystemwithacleanclothsoakedwithdisinfectant.
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Donotspraydisinfectantdirectlyonthesystem.
Ifthedisinfectantintothesystemmaycauseproblemsor
accidents.
Donotusethebelowlistedproducts
Disinfectantschlorinebase
Disinfectantsthatcorrodemetals,plastics,rubbers,etc.
Disinfectantsatomized
volatileDisinfectants
Usetheminimumamountofdisinfectant
Overtime,thedisinfectionmaycausedamageto
paintdiscolorationordeteriorationofresinssuchasplasticand
rubbers.
3Aftercompletingthework,checkthefollowingpoints:
Thereshouldbenowaterordisinfectantjoinedthesystem.
Thetoolsusedtocleananddisinfectthesystemshouldbe
cleanafteruse.
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Chapter6
optional
Thischapterexplainshowtooperatetheoptional(operation,maintenance,
setting,etc.).
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6.1LaserIndicator(Laserpointer)
ThelaserconsistsofaprojectorunitintheXraytube,plate
withcentralidentificationintheimageintensifierandtheON/OFF
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ofthelaserbeamonthetopside.
1Press"LaserPointer"onthemainpanelinitiatestheissueof
laserbeam.(Lamplightsuponthedashboard)
Alaserbeamisemittedwhileitappearsa
markingacrossonthemonitorscreenimage.
Thebuttonisilluminatedwhenactive.
Whenyoupressthebuttonagain,thelaserbeamis
interrupted.
2Pressingthesamekeyagainthelaserbeamisturnedoff.
Markingimagecrossdisappearsfromthemonitor.
Thelaserbeamcontinuestobeoutputwhilethebuttonis
on.
Figure6.1LaserPointer(IndicatorLaser)
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Neverlookdirectlyintothelaserbeam.
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laserradiationinfo:
Power:1.0mWmax.
Powerconsumption:5V200mA
CW:635nm
Class2(IEC8251)
Thisoptionwasdevelopedtomarktheareatobeexposedto
xraysmoreaccurately,soyoucanoptimizetheamountof
XraysirradiatedwhileavoidingdoseofXraysunnecessaryforthepatientand
medicalteam.
AdditionalInformation:
Thevaluesandindicationscanbeobservedinthemachinescreenor
onthemonitors.
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6.2CassetteSupport
Youcanmountacassetteholderintheintensifierunit
Image.
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Installthecassetteholdercorrectlyforitnot
presentlaterfailures.
Adjustingthecassetteholder
1Unscrewthescrew(1).
2Lettherunner(2)contactastheflangemounted(3),push
thecassetteholderforwardandlockthefixedguide(4)mountedontheflange
(3).
3Tightenthescrew(1)untilthetipcontactface
rearoftheblock(5).
Inthispositionthecassetteholdercanbemountedanditwill
rotatefreelyintheappendixoftheintensifierunit
image.
4Adjustthecassetteholderpositionaccordingtotheposition
Radiographic.
Figure6.2CassetteSupport
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6.3HandTrigger
Thison/offcontroltheradiationXrays.
1Pressthehandshutterbuttontothefirstlevel(level
Radiographicpreparation).
Startspreparationforradiography.
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TheStandbyindicatorlampequipmentwillturnoff
temporarily.
Whentheradiographicpreparationiscomplete,thelamp
standbyindicatorwilllightupagain.
2Pressthehandcontroltothesecondlevel(levelofpreparation
RadiographicandexposuretoXrays).
TheXrayradiationwillstart.
DuringexposuretoXrays,theradiationmonitorindicator
willlight.
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Chapter7
Technicaldata
114
Page115
7.1TechnicalSpecifications
7.1.1)CararmCsupport
Item
FocusII
verticaloffset
horizontalscroll
axialrotationofthearc
Arcrotation
lateralmovement
OpescopeActive
900mm
450mm
200mm
120th
420
12.5
FullOpescope
900mm
450mm
200mm
120th
420
12.5
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freeareabetweentube/II
DepthofArc
700mm
780mm(9II")
700mm
780mm(9II")
7.1.2)Unitcontroller/generatorxray
Item
Ratedpower
voltagerange(RAD/Fluoro)
mAsrange(RAD/Fluoro)
Maximumcurrent(RAD)
Maximumcurrent(FLUORO)
pulsedfluoroscopy
fluoroscopycontinues
FluoroscopyHighPulsed
Quality(BOOST)
fluoroscopytime
tobecontinued
Inverterfrequency
OpescopeActive
FullOpescope
2kW
2kW
40to110kVin1kVstep40to110kVin1kVstep
0.5to27insteps200mAs
0.5to27insteps200mAs
20mA
20mA
16mA
16mA
0.5/1/2/3.75/7.5and15fps0.5/1/2/3.75/7.5and15fps
Yes
Yes
Yes
Yes
45minutesormore
45minutesormore
50kHz
50kHz
7.1.3)tubexray
Item
caloriccapacityoftheanode
dissipationcapacity
Callusanode
caloriccapacity
set
SpotSize
AnodeAngle
anodematerial
Typeanode
feeding
inherentfiltration
OpescopeActive
100.000HU
FullOpescope
100.000HU
550W
550W
680.000HU
680.000HU
0.6mm2
8th
Tungsten
Fixed
Highfrequency
2,9mmAl
0.6mm2
8th
Tungsten
Fixed
Highfrequency
2,9mmAl
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7.1.4)Collimator
Item
collimatoroctagonal
collimatedparallel
compensatingfilters
OpescopeActive
Motorizedwithbladesof
Lead(Pb)
Copper(Cu)andsystem
rotation.
Motor.Coppermade
(Cu)andthicknesses
0.1mm,0.2mmand0.3mm
FullOpescope
Lead(Pb)
Copper(Cu)andsystem
rotation.
Motor.Coppermade
(Cu)andthicknesses
0.1mm,0.2mmand0.3mm
7.1.5)Intensifierimages(II)
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Item
Intensifier6Image"/4"
Intensifier7Image"
Intensifier9Image"/6"
Item
Sizeoffields
centralResolution
maxim
OpescopeActive
Yes
Optional
Optional
II6"/4"
6"/4"(16cm/10cm)
FullOpescope
Yes
II7"
7"(18cm)
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50
II9"/6"
9"/6"(23cm/16cm)
50
7.1.6)ImageProcessingUnit
Item
Cameratype
acquisitionmatrix
Resolution
fluoroscopyacquisitionrate
serialacquisitionrate
Imageprocessing
OpescopeActive
CCD400kP
768x494(EIC)or752x582
(CCIR)
8bits
30frames/second
5frames/second
FullOpescope
CCD1MP
1024x1024
12bits
30frames/second
15frames/sec
windowsettings/level,brightness
andcontrast,gamma,highlight
windowsettings/level,brightnessedges,zoom/pan2xzoom,
andcontrast,gamma,highlight displayingmultipleimages
edges,zoom/pan2xzoom,
anascreenannotation,measurements,
displayingmultipleimages
SubtractionAngiography
anascreenannotation,measurements,
Digital(DSA)inrealtime,
SubtractionAngiography
remascara,displacement
Digital(DSA)inrealtime,
pixel(pixelshift),landmarking
remascara,displacement
(Anatomicalreference)
pixel(pixelshift),landmarking
positive/negativeinversion,
(Anatomicalreference)
right/leftinversion,
positive/negativeinversion,
reversingup/downmode
right/leftinversion,
roadmappingcineandRSM
reversingup/downmode
DSA(angiography
cineandroadmapping.
DigitalSubtractionintime
realtimewithmask
real).
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AcquisitionofDSA
Capacityof
imagestorage
DICOM3.0protocol
0.5to5frames/second
0.5to7.5frames/second
Upto30,000imagesonthedisc
Upto16,770imagesonthedisc
hard
hard
Upto100imagesinmemory
Upto68imagesinmemory
RAM
RAM
Upto300images/CDR
DICOM3.0format
DICOMPrint
DICOMStorage(send/receive)
DICOMWorklist
DICOMMediaStorage
7.1.7)Monitor
Item
LCDMonitor18"
LCDmonitor18"touchscreen
OpescopeActive
Optional
Optional
FullOpescope
Optional
Optional
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LCDMonitor15"
CRTMonitor17"
LCDMonitor19"
Monochrome
LCDMonitor19"color
Optional
Yes
Optional
Optional
Optional
Yes
Optional
Optional
Optional
Optional
7.1.7)antidifusoraGrade
Item
Gridreason
griddensity
Interespaador
OpescopeActive
10:1or8:1
40lines/cm
Aluminum(Al)orfiber
FullOpescope
10:1or8:1
40lines/cm
Aluminum(Al)orfiber
Note:Thetechnicalinformationsuchascircuitdiagrams,lists
components,descriptions,instructionsforcalibrationandtestingareprovided
bythemanufacturertostaffand/orqualifiedandauthorizedtechnicalassistance
Brazil.
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Figure7.1xraytube
Subtitle:
Referenceaxistheaxisofreference
Focalspotfocalpoint
UnitUnit
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Figure7.2Heatingandcoolingcurvesofthexraytubeanodeand
Subtitle:
XRaytubeassemblyheatingandcoolingcurveheatingandcoolingcurve
xraytube
AnodeHeatingandCoolingCurveheatingandcoolingcurveoftheanode
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Figure7.3Loadevaluationboardsandcharacteristicsofemissionandfilament
Subtitle:
SingleLoadRatingChartsApplicationAssessmentFrameworksinasinglecharge
AndFilamentEmissionCharacteristicsemissioncharacteristicsandfilament
XrayTubecurrentTubecurrentxray
TimeTime
FilamentCurrentFilamentCurrent
FilamentVoltageFilamentvoltage
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Monitor
Kind
LCDMonitor18"
LCDMonitor15"
CRTMonitor17"
Specification
ScreenMatrix:1280x1024
ScreenType:flat(flat)withtechnology
TFT
ScreenSize:18"(diagonal)
TFTandtouch
TFT
ScreenType:CRT
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LCDMonitor19"Monochrome
LCD19"ColorMonitor
TFT
TFTandtouch
TFT
Videotape
Videosignal:NTSCstandardcolorsignal
Power:AC120V,60Hz,0.6A
Videosignal:
Input:BNC1.0Vpp,75ohms.Sin(4P)Y:1.0Vpp,75ohms.W:
0.286Vpp,75ohms.
Output:BNC1.0Vpp,75ohms.Sout(4P)Y:1.0Vpp,75ohms.W:
0.286Vpp,75ohms.
Audiosignal:
Input:LINEINCH1/CH2(PINRCA)10dBu,47kohms.Microphone
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NormalaudioCH1(RCAJackQ)to600ohmmic60dBu,3kohms.
Output:AUDIOMONITOR(RCAPIN)5dBu,47kohm.LINEOUTCH
1/CH2(RCAPIN)10dBu,47kohm.
tapeformat/speed:SVHS/VHS/33.35mm/sec
VideoColorPrinter
Resolution:403DPI
PrintedImagesize:(NTSC)3"x27/8"/5"x35/8"
Printspeed(NTSC)1929seconds
Powersupply:100120volts,1.8A220240volt,1.0A
VideoPrinterBlackandWhite
Resolution:1280DOT
Effectivepixels:508linesx1280dots
PrintSpeed:3.07.0onthe2nd
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Powersupply:100120volts,1.8A220240volt,1.0A
optional
TapeSupport
IndicatorLaser
SterilisationCase
HandControl
LCDMonitor
VideoSonyPrinter
DVDrecorderSony
ExtensionDistanceSourceSkin
OptionalOPESCOPEFULL
LCDMonitorTouch
DICOM3.0Kit(Print(IncludesCDROMwithsoftware)/Storage(send/receive)
(IncludesCDROMwithsoftware)andWorklist(IncludesCDROMwithsoftwareandPC,
consistsofMonitor,CPU,mouseandkeyboard))
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FluoroimageinSupportCarDisplaywithCArm
Dosemeter(DAP)
OptionalOPESCOPEASSETS
VariableField(9"/6")toII
Fibergrid
HandleControlII(ImageIntensifier)
TypeMemory"LOOP"
LCDMonitor6.4"
DigitalImageProcessingUnitwithSubtractionAngiography
Digital(DSA)
MODRecorder
MODMedia
WeightCarHolderwithArmC:250kg
WeightCartMonitors:145kg
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Thecontrollerunitofxrayconstitutesthejunctionhousing(outsideand
xraygenerator)
TheCarchsupport,supportxraytube,xraytube,collimator,
highvoltagegenerator,imageintensifier,powersupplyand
controllerunitxraysareofexclusiveuseoftheequipment.
Thelaserpoint,monitors,standandsupportDICOMkitaremanufacturing
Shimadzu,buttheymaybeusedinotherShimadzuequipment.
ThevideoprinterandvideocassettearenotmanufacturedbyShimadzu,
gettingthepurchasethecustomer'sdiscretion.(Seeminimumspecifications)
graphicillustrations
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Figure7.4xraytube
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Figure7.5Collimator
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Figure7.6highvoltagegeneratorphotos
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Figure7.7imageintensifierPhoto
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Figure7.8Monitor
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Figure7.9Figurepowersupplyboard
Subtitle:
2Baseboard
3Limiter
4Label
5Spacers
7Limiter
8,9,10,11and12Powersupply
13Filter
14Label
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Figure7.10Laserpointillustration
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Figure7.11StandformonitorPhoto
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Figure7.13SupportCarBoomCwith9II"
128
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Figure7.14SupportCarBoomCwith7II"
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Figure7.15SupportCarBoomCIIwith6"/4"
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7.2ConditionsforInstallationandUse
1.EnvironmentalConditions:
Temperature
10Cto40C
Relativehumidity
Atmosphericpressure
700hPato1060hPa
Theatmosphereshouldbegasfree
corrosiveandexplosive
2.SourceofEnergy:
Equipment
SimplephaseAC
Frequency
50or60Hz
Capacity
3.5kVA
VoltageandImpedance
100,110,120V10%0.2Max.
200,220,230,240V10%0.8Max.
Earth
typeD
3.PowerConsumption
Inuse:
35A(100,110,120V),17,5A(200.220,230,240V)
standby:
15A(100,110,120V),10A(200.220,230,240V)
Installation
Installationoftheequipmentshouldbeperformedonlybypersonnel
and/ordealer.
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AuthorizedTechnicalAssistance
Address:MarquesAvenueStVincent,1771SP
Tel.:(11)21341688/Fax:(11)36112209
email:webmaster@shimadzu.com.br
website:www.shimadzu.com.br
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7.3ConditionsforStorage
Temperature
10Cto40C
Relativehumidity
Atmosphericpressure
700hPato1060hPa
Theatmosphereshouldbegasfree
corrosiveandexplosive
7.4DoseInformation
7.4.1LocationofSignificantZonesofOccupation
ArcCposition
TheforwardverticalpositionseeFigure7:16
AnteroposteriorverticalpositionseeFigure7:17
HorizontalpositionseeFigure7:18
SignificantzoneofoccupationandmeasurementpointsseeFigures
7:16,7:17and7:18
Fantom
Externaldimensions:35x35x15(cm)
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Figure7.16PositionposteroanteriorVertical(measuredinmm)
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Figure7:17PositionAnteroPosteriorVertical(measuredinmm)
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Figure7.18Horizontalposition(measuredinmm)
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Heightfromtheground
Figure7.19posterioranteriorpositionvertical(medicalcm)
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Heightfromtheground
Figure7.20anteroposteriorverticalposition(measuredincm)
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Heightfromtheground
Figure7.21Horizontalposition(measuredincm)
RepresentativeandTechnicalAssistanceinBrazil
AvenueMarquesdeSoVicente,1771BarraFunda
SoPauloSPCEP:01139003
Tel.:(11)21341688
Fax:(11)36112209
email:marketing@shimadzu.com.br
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______________________
Technicalmanager
ConstantineLuizDiPIPI
CREA/SP0682526854
________________________
Legalresponsible
AkihikoKato
CEO
137
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