Alcon LenSx 8065998162 LenSx Laser User Manual

Alcon LenSx, Inc. LenSx Laser

User Manual

DRAFTLENSXLASERSYSTEMOPERATOR’SMANUALAlconLenSx,Inc.33JourneyAlisoViejo,CA926560086DateofIssue:January2011DistrubutedBy:AlconLaboratories,Inc.6201SouthFreewayFortWorth,TX76134‐2099AlconLaboratories,UKLtd.PentagonPark,BoundaryWayHemelHempsteadHertfordshire,HP27UD,UK
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A iiLenSxLaserSystemOperator’sManualTheinformationcontainedinthisdocumentistheconfidentialandproprietarypropertyofAlconLenSx,Inc.(LenSx).Anyreproduction,dissemination,ordistributionofthisdocumentinwholeorinpartwithoutpriorwrittenpermissionofLenSxisstrictlyprohibited.Whileeveryefforthasbeenmadetoensuretheaccuracyofinformationprovidedinthisdocument,pleasenotethattheinformation,figures,illustrations,tables,specifications,andschematicscontainedhereinaresubjecttochangewithoutnotice.PleasedirectallinquiriesregardingthismanualorforserviceassistancetoAlconLenSx,Inc.,33Journey,AlisoViejo,California92656.Telephone(949)360‐6010(intheUnitedStates)LenSxandtheLenSxlogoareregisteredtrademarksofAlconLenSxInc.©2011LenSxLasers,Inc.Allrightsreserved.NoportionofthismanualmaybereproducedortransmittedinanyformorbyanymeanswithouttheexpresspriorwrittenconsentofLenSx.
DRAFTTableofContentsTABLEOFCONTENTS............................................................................................................................01LENSXLASERSYSTEM..................................................................................................................31.1INDICATIONSFORUSE.......................................................................................................................31.2SUMMARYDESCRIPTION...................................................................................................................31.3CONTRAINDICATIONS........................................................................................................................31.4COMPLICATIONS..............................................................................................................................42GENERALWARNINGSANDPRECAUTIONS....................................................................................62.1WARNINGS.....................................................................................................................................62.1.1UnauthorizedUseoftheLaser................................................................................................72.1.2Electrical..................................................................................................................................72.1.3EyeSafetyandNominalOpticalHazardDistance...................................................................72.1.4Mechanical/Motion.................................................................................................................82.1.5Combustion/Fire......................................................................................................................82.1.6Environmental/Chemical.........................................................................................................82.1.7Sterilization/BiologicalContamination...................................................................................92.1.8EmergencyOff.........................................................................................................................92.2PRECAUTIONS..................................................................................................................................92.2.1General....................................................................................................................................92.2.2PatientSelection......................................................................................................................92.2.3SurgicalProcedure...................................................................................................................92.2.4PowerFailureorEmergencyOff..............................................................................................92.3SAFETYFEATURES..........................................................................................................................102.3.1KeySwitch.............................................................................................................................102.3.2LaserEnabling.......................................................................................................................102.3.3LaserEmissionIndicator........................................................................................................102.3.4ProtectiveHousingandSafetyInterlock...............................................................................102.3.5Labels.....................................................................................................................................102.3.6SafetyShutterMonitor..........................................................................................................112.3.7FootswitchControl................................................................................................................112.3.8RemoteInterlockConnector..................................................................................................112.3.9EmergencyOFFSwitch..........................................................................................................112.3.10LaserCoolingSystem........................................................................................................112.3.11ManualGantryLift............................................................................................................122.3.12PatientInterfaceRFID.......................................................................................................122.3.13ConsoleFootbrake............................................................................................................122.4DEVICEELECTRICALCLASSIFICATION..................................................................................................123SYSTEMDESCRIPTION................................................................................................................133.1INTRODUCTION..............................................................................................................................133.2SYSTEMOVERVIEW........................................................................................................................133.2.1FemtosecondLaserEngine....................................................................................................153.2.2EnergyMonitor......................................................................................................................153.2.3DeliverySystem.....................................................................................................................153.2.4VideoMicroscope..................................................................................................................15
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 13.2.5OpticalCoherenceTomography(OCT)imagingdevice.........................................................163.2.6PatientInterface....................................................................................................................163.2.7SurgeonControls...................................................................................................................173.2.8SystemElectronics.................................................................................................................173.2.9ConsoleChassis.....................................................................................................................183.3PROCEDUREOVERVIEW...................................................................................................................183.3.1Pre‐Operative........................................................................................................................193.3.2AnteriorCapsulotomy...........................................................................................................193.3.3Phacofragmentation.............................................................................................................203.3.4CombinedTreatments...........................................................................................................203.3.5Post‐Operative.......................................................................................................................204CONTROLS,INDICATORSANDDISPLAYS....................................................................................214.1DISPLAYPANEL&KEYBOARD...........................................................................................................214.2SURGICALDISPLAY.........................................................................................................................214.2.1VideoMicroscope..................................................................................................................214.2.2OpticalCoherenceTomography(OCT)Device......................................................................214.3DELIVERYSYSTEMPANEL.................................................................................................................224.3.1Joystick..................................................................................................................................224.3.2DeliverySystemTouchScreen...............................................................................................224.3.3ApplanationIndicator............................................................................................................224.3.4IlluminationandMicroscopeFocus.......................................................................................224.3.5FixationLight.........................................................................................................................234.4SYSTEMPOWER.............................................................................................................................234.4.1MainInputSwitch.................................................................................................................234.4.2KeySwitch.............................................................................................................................234.4.3Emergencyoffswitch............................................................................................................234.5FOOTSWITCH.................................................................................................................................234.6SOFTWARECONTROLS....................................................................................................................234.6.1SystemStartup......................................................................................................................234.6.2ProcedureProgrammingWindow.........................................................................................244.6.3SystemChecks.......................................................................................................................244.6.4UserRegistration...................................................................................................................244.6.5Shutdown..............................................................................................................................244.6.6About.....................................................................................................................................244.7ACCESSORIES&DETACHABLEPARTS.................................................................................................255SYSTEMREQUIREMENTS............................................................................................................265.1ELECTRICAL...................................................................................................................................265.2ENVIRONMENTAL...........................................................................................................................266PROCEDUREGUIDE....................................................................................................................276.1PREPARATIONANDTREATMENTPLANNING........................................................................................276.2STARTUP&PROCEDURESELECTION.................................................................................................276.2.1ProgrammingtheLensPattern.............................................................................................316.2.2ProgrammingtheCapsulotomyPattern...............................................................................326.2.3ProgrammingthePrimaryIncisionPattern...........................................................................326.2.4ProgrammingtheSecondaryIncisionPattern.......................................................................336.2.5ProgrammingtheArcuateIncisionPatterns.........................................................................34
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 26.2.6CombiningPatterns...............................................................................................................356.2.7CompletingPatternSelection................................................................................................366.3PREPARINGTHEPATIENTINTERFACE.................................................................................................376.4DOCKING......................................................................................................................................386.5PATTERNPOSITIONING....................................................................................................................406.5.1Overview................................................................................................................................406.5.2VideoMicroscope,OCTImageGuidesandPatternGraphics...............................................416.5.3LimbusCentration.................................................................................................................416.5.4PrimaryandSecondaryIncisionAlignment...........................................................................426.5.5LensAlignment......................................................................................................................436.5.6CapsuleDepthAdjustment....................................................................................................446.5.7LensDepthAdjustment.........................................................................................................476.5.8CornealPrimaryandSecondaryIncisionsThicknessAdjustment.........................................496.5.9ArcuateIncisionThicknessAdjustments...............................................................................516.6CONFIRMATION.............................................................................................................................526.7TREATMENT..................................................................................................................................536.8PROCEDURECOMPLETION...............................................................................................................557CALIBRATIONANDALIGNMENT.................................................................................................567.1ENERGYCALIBRATION.....................................................................................................................567.2BEAMSTEERING............................................................................................................................568SERVICEANDMAINTENANCE.....................................................................................................578.1TRANSPORTANDSTORAGE..............................................................................................................579TROUBLESHOOTING..................................................................................................................5810LABELS.......................................................................................................................................6010.1CONSOLELABELS...........................................................................................................................6011SYSTEMSPECIFICATIONS...........................................................................................................6312WARRANTYINFORMATION.......................................................................................................6413ABBREVIATIONSANDTERMS.....................................................................................................6513.1GENERALABBREVIATIONS................................................................................................................6513.2TERMS.........................................................................................................................................6514NOMINALOPTICALHAZARDDISTANCE(NOHD).........................................................................6615DECLARATIONOFCOMPLIANCE.................................................................................................69
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 31 LenSxLaserSystem1.1 IndicationsforUseTheLenSxLaserisindicatedforuseinpatientsundergoingcataractsurgeryforremovalofthecrystallinelens.Intendedusesincataractsurgeryincludeanteriorcapsulotomy,phacofragmentation,andthecreationofsingleplaneandmulti‐planearccuts/incisionsinthecornea,eachofwhichmaybeperformedeitherindividuallyorconsecutivelyduringthesameprocedure.1.2 SummaryDescriptionTheLenSxLasercreatesincisionsthroughtightlyfocusedfemtosecondlaserpulsesthatcuttissuewithmicron‐scaleprecision.Theincisionisachievedbycontiguouslyplacedmicro‐photodisruptionsscannedbyacomputer‐controlleddeliverysystem.TheLenSxLaserSystemshouldonlybeoperatedbyaphysiciantrainedinitsuse.TheLenSxLaserdeliverysystememploysonesteriledisposableLenSxLaserPatientInterfaceconsistingofanapplanationlensandsuctionring.ThePatientInterfaceisintendedforsingle‐use,only.RefertotheInstructionforUsesuppliedwiththeLenSxLaserPatientInterfaceforpreparationandapplicationinstructionsforthepatientinterface.Thephysicianshouldbasepatientselectioncriteriaonprofessionalexperience,publishedliterature,andeducationalcourses.Adultpatientsshouldbescheduledtoundergocataractextraction.1.3 ContraindicationsContraindicationsfortheanteriorcapsulotomy,phacofragmentationofthelensusingtheLenSxLaserincludethefollowing: Cornealdiseasethatprecludesapplanationofthecorneaortransmissionoflaserlightat1030nmwavelength Descemetocelewithimpendingcornealrupture Cornealopacitythatwouldinterferewiththelaserbeam Presenceofbloodorothermaterialintheanteriorchamber Hypotony,glaucoma,orthepresenceofacornealimplant Poorlydilatingpupil,suchthattheirisisnotperipheraltotheintendeddiameterforthecapsulotomy
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 4 Conditionswhichwouldcauseinadequateclearancebetweentheintendedcapsulotomydepthandtheendothelium(applicabletocapsulotomyonly) Residual,recurrent,activeocularoreyeliddisease,includinganycornealabnormality(forexample,recurrentcornealerosion,severebasementmembranedisease) Ahistoryoflensorzonularinstability Anycontraindicationstocataractorkeratoplastysurgery Thisdeviceisnotintendedforuseinpediatricsurgery.ContraindicationsforcornealincisionsusingtheLenSxLaserincludethefollowing: Previouscornealincisionsthatmightprovideapotentialspaceintowhichthegasproducedbytheprocedurecanescape Cornealthicknessrequirementsthatarebeyondtherangeofthesystem Cornealopacitythatwouldinterferewiththelaserbeam Hypotony,glaucoma,orthepresenceofacornealimplant Residual,recurrent,activeocularoreyeliddisease,includinganycornealabnormality(forexample,recurrentcornealerosion,severebasementmembranedisease) Thisdeviceisnotintendedforuseinpediatricsurgery.Potentialcontraindicationsarenotlimitedtothoseincludedinthislist.1.4 ComplicationsPossiblecomplicationsresultingfromanteriorcapsulotomy,phacofragmentation,orcreationofapartialthicknessorfull‐thicknesscutorincisioninclude: Capsulotomy,phacofragmentation,orcutorincisiondecentration Interruptedcapsulotomy,fragmentation,orcornealincisionprocedure Capsulartear Cornealabrasionordefect Pain Infection Bleeding Damagetointraocularstructures Anteriorchamberfluidleakage,anteriorchambercollapseInthecaseofanincompleteorinterruptedcapsulotomy,theproceduremaybeimmediatelyrepeatedwithaslightlylargerdiametertocompletethecapsulotomy.Inthecaseofanincompleteorinterruptedfragmentationorpartialthicknessorfull‐thicknessarccut/incision,theprocedurecanberepeatedataslightlydifferentpositionusingthecentrationfeature.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 5Inthecaseofanincompleteorinterrupted360‐degreekeratoplastyincision,theproceduremaybeimmediatelyrepeatedwithaslightlylargerdiametertotherecipientandaresizedcornealdonorbutton.Inthecaseofaninterruptedprocedureduringdonortissuepreparation,repeatingtheprocedureatalargerdiametermaynotberecommendediftherecipientcorneahasbeenalreadypreparedataoriginaldiameter.Inthiscase,anewdonorcorneamayberequired.CataractremovalshouldbeperformedafteranteriorcapsulotomywiththeLenSxLaser.IntheinitialclinicalprotocolusingtheLenSx,cataractremovalwasbegunwithin30minutesafterthelaserprocedure.InpreviousstudiesusingtheNd:YAGlasertoperformanteriorcapsulotomy,anteriorchamberinflammationandelevatedintraocularpressurewerenotedwhencataractsurgerywasdelayedfromonehourtouptoonedayfollowinglasertreatment.1,2TheNd:YAGlaserrequires100timesmoreenergyperpulsethanfemtosecondlaserstoinducephotodisruption.Potentialcomplicationsarenotlimitedtothoseincludedinthislist.Thesecomplicationsmaybesurgicallyormedicallymanagedusingcurrentlyacceptedtechniquesforcataractorkeratoplastyprocedures.1WoodwardPM.AnteriorCapsulotomyusinganeodymiumYAGlaser.AnnOphthalmol:16:534‐9,1984.2SzwedaE.PreoperativeanteriorcapsulotomyusingYAGlaserincataractextractionbytheenvelopmethod.KlinOczna:93:334‐6,1991.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 62 WarningsandPrecautions2.1 WarningsTheLenSxLaserisindicatedforuseinpatientsundergoingcataractsurgeryforremovalofthecrystallinelens.Intendedusesincataractsurgeryincludeanteriorcapsulotomy,phacofragmentation,andthecreationofsingleplaneandmulti‐planearccuts/incisionsinthecornea,eachofwhichmaybeperformedeitherindividuallyorconsecutivelyduringthesameprocedure.UnitedStatesFederalLawrestrictsthisdevicetosaleandusebyorontheorderofaphysicianorlicensedeyecarepractitioner.UnitedStatesFederalLawrestrictstheuseofthisdevicetopractitionerswhohavebeentrainedintheoperationofthisdevice.Theperformanceofsurgicalprocedures,operationofcontrols,oranyotheradjustmentsotherthanthosespecifiedhereinmayresultinhazardousconditionsforbothpatientsandpersonnel.Whiletheriskoffireisextremelylow,theLenSxLasershouldnotbeoperatedinthepresenceofflammableanesthetics,volatilesubstances,oroxygenflowlines.WARNING:DonotusecellphonesorpagersofanykindinthesameroomastheLenSxLaser.TheLenSxLasercomplieswith47CRF15FederalCommunicationCommissionRulesforradiofrequencydevices.ChangesormodificationsnotexpresslyapprovedbyAlconLenSxInc.canvoidtheoperator’sauthoritytooperatethisradiofrequencydevice.OnlytrainedLenSxrepresentativesshouldperformunpacking,installation,andservicingoftheLenSxLaser.CoversarenottoberemovedbyanyoneotherthanLenSxpersonnel.AccidentalcontactwiththehighvoltageelectricalcircuitsintheinterioroftheLenSxLaserconsolemayresultinseriousinjuryordeath.Ocularexposuretocollimatedbeamscontainedintheconsoleinteriorcanproduceretinaldamage.SurgicallasersmustmeetrequirementsestablishedbytheFoodandDrugAdministration(FDA)CenterforDevicesandRadiologicalHealthandinternationalstandardsandregulationsforsurgicallasers.Specificcontrolsarerequiredthatpreventaccidentalexposureoflaserenergytotheeyeandskinfrombothdirectandreflectedlaserbeams.Inaddition,precautionsmustbetakeninthesurgicalareatopreventfireandelectricalhazards.ImproperuseoftheLenSxLasermayresultinpatientcornealtrauma,infection,complications,ormechanicaltraumatoeitherpatientorpersonnel.Allwarnings,labelingandinstructionsmustbeobserved.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 72.1.1 UnauthorizedUseoftheLaserWhennotinuse,themasterkeyshouldberemovedfromtheLenSxLaserandkeptinasecurelocationtopreventuseofthelaserbyunauthorizedpersonnel.OncetheconsoleisswitchedON,passwordprotectionisrequiredtoaccessanylaserfunctions.2.1.2 ElectricalHighvoltageelectricalcircuitsareaccessibleiftheconsolepanelsareremoved.OnlytrainedLenSxservicerepresentativesshouldattempttoopentheconsolepanels.Seriousinjuryordeathmayoccurwhilecontactingelectricalcircuitsintheunitinterior.Toolsarerequiredtoremovetheconsolepanels.PanelsshouldnotberemovedbyanyoneotherthanLenSxservicepersonnel.WhiletheLenSxLaserrequires120VAC,60Hz,10Aelectricalservice,thesystemisconfigurableforthefollowinginputvoltages:100VAC/12A,120V/10A,220‐240V/7A,and50/60Hz.Thelinevoltageshouldbetestedpriortolaserinstallationandmustbewithinspecifiedlimitsforproperoperationoftheunit.AninterlockconnectionallowstheuseofsafetyinterlockswitchesontheoperatingsuitedoorsthatautomaticallyplacethelaserinSTANDBYmodewhenthesuitedoor(s)isopened.TheareaaroundtheLenSxLaserandthefootswitchshouldbekeptdry.Thelasershouldnotbeoperatedifthereisanyleakageofwaterfromtheconsole.ALenSxservicerepresentativeshouldbecontactedimmediately.Iftheunitpowercordisfrayedorotherwisedamaged,donotuseunituntilcordhasbeenreplaced.AtrippinghazardexistsiftheACpowercordisnotprotectedfromfoottraffic.CaremustbetakentoavoidaccidentalunpluggingoftheLenSxLaserduringtreatment.2.1.3 EyeSafetyandNominalOpticalHazardDistanceTheNOHDisdefinedaccordingtoAmericanNationalStandardsInstituteZ136.1‐2007,“AmericanNationalStandardforSafeUseofLasers”.TheNOHDiscomputedintermsoftheMaximumPermissibleExposure(MPE)allowedontotheeye.FortheLenSxLasertheNOHDcalculatedusingthisstandardisshortduetothesmallpulseenergiesemittedbythelaser.ThemostconservativeNOHDforadirectbeamexposurefromtheLenSxLaseris106cm(SeeAppendix2).ThismeansthatonlythepatientoperativeeyewillbeexposedtolaserradiationexceedingtheMPE.Thepracticalconsequenceisthatoperatorsandsupportpersonnelarenotatriskofopticalradiationduringnormalandroutineoperationofthelaser.AnyserviceoperationrequiringtheremovalofanycoversorshieldsontheconsolewillrequireeyewearofOD≥5atawavelength
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 8of1030nm.OnlyauthorizedLenSxservicerepresentativesshouldattempttoremoveconsolecoversortoservicetheLenSxLaser.Standardlasersafetyprotocolrequiresthatawarningsignbeplacedonthedooroftheroomwhenthelaserisinuse,towarnpersonneloflaserusageinprogressbeforetheyenterthecontrolledarea.Thedoorshouldbeclosedduringtheoperationofthelaser.Removingtheconsolecoversincreasestheriskofeyeinjury.OnlytrainedLenSxservicerepresentativesshouldremovetheconsolecoversorattemptservicingoftheLenSxLaser.Aninterlockconnectionallowstheuseofsafetyinterlockswitchesontheoperatingsuitedoor(s)thatautomaticallydisableslaseremissionwhenthesurgicalsuitedoor(s)isopened.ThePatientInterfacedisposablecannotbereusedorre‐sterilized;theLenSxLaserwillnotbeoperablewithapreviouslyusedPatientInterface.2.1.4 Mechanical/MotionTheLenSxLaserconsoleisstableandmobilewithinanoperatingroom.Nosignificanttippingorrollinghazardexistsoncetheconsoleisplacedinthelockedpositionforsurgery.Onlytrainedpersonnelshouldmovetheconsole.Iftheconsolemustbemovedforanyreason,aLenSxservicerepresentativeshouldbecontacted.Wheninstalled,afootbrakeatthebackoftheunitpreventstheconsolefromrolling.Thefootbrakemustbeengagedduringtreatment.Removingtheconsolecoversisapotentialmechanicalhazard.ThisoperationshouldbeperformedonlybytrainedLenSxservicerepresentatives.Afterdockingiscomplete,theusershouldnotmovethedeliverysystemuntilpatientisdisengagedfromthesystem.2.1.5 Combustion/FireAlthoughthepossibilityofcombustionisremote,flammableanestheticsshouldnotbeusedwiththeLenSxLaser.Oxygenlinesandflammablematerialsshouldbekeptclearoftheimmediateareasurroundingthelaseraperture.2.1.6 Environmental/ChemicalNohazardousgasesorchemicalsareusedintheLenSxLaser.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 92.1.7 Sterilization/BiologicalContaminationTheLenSxLaserisusedwiththeLenSxLaserPatientInterface.Thissterileassemblycannotbereusedandshouldbedisposedofasmedicalwaste.2.1.8 EmergencyOffIntheeventofanemergency,theLenSxLasershouldbeimmediatelyshutdownbypressingtheredemergencyOFFbuttonlocatedattopcenteronthefrontpanel.IftheLenSxLaserisshutdown(bypressingtheEmergencyOffbuttonorbyalossofpower),thepatientmayberemovedfromunderthedeliverysystembyloweringthebedorbyactuatingthemanualgantryliftlocatedatthebaseofthedeliverysystemgantry.2.2 Precautions2.2.1 GeneralThePatientInterfacewillincreaseintraocularpressureduringtheprocedure.Caremustbetakentominimizeapplanationtimes.Incompleteapplanationmayresultinnon‐uniformorincompleteincisions.2.2.2 PatientSelection Patientsmustbeabletolieflatandmotionlessinasupineposition. Patientmustbeabletounderstandandgiveaninformedconsent. Patientsmustbeabletotoleratelocalortopicalanesthesia.PatientswithelevatedIOPshouldusetopicalsteroidsonlyunderclosemedicalsupervision.2.2.3 SurgicalProcedureFullthicknesscutsorincisionsshouldbeperformedwithinstrumentsandsuppliesonstandbytosealtheeyeincaseofanteriorchambercollapseorfluidleakage.SurgicaltreatmentshouldbehaltediftheOCTimageispoorordisrupted.Duringuse,theusershouldnotmove,shakeorbumpthedeliverysystemafterdockingiscompleteduntilpatientisdisengagedfromthesystem.2.2.4 PowerFailureorEmergencyOffIntheeventofpowerfailureorinitiationoftheEmergencyOffbutton,removethepatientinterfacetubefromthevacuumporttoreleasetheeyefromsuction.Graspthedeliverysystemobjectiveandraiseit1to2inchestosafelyremovethepatientfromthesurgicalfield.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 10TheManualGantryLift,locatedatthebaseofthegantry,allowstheusertolifttheunpoweredgantryifadditionalpatientclearanceisneeded.Alternatively,thepatientbedmaybeloweredtoprovideclearance.2.3 SafetyFeaturesTheLenSxLasercomplieswithallperformancestandardsspecifiedbytheCenterforDevicesandRadiologicalHealthoftheU.S.FoodandDrugAdministrationandinternationalstandardsforsurgicallasers,andincludesthefollowingsafetyfeatures:2.3.1 KeySwitchThelaserconsolecanbeturnedONonlywiththeappropriatemasterkeythatcontrolsthemasterswitch.ThekeyONswitchislocatedatthebottomcenterofthefrontpanelofthelaserconsole.WhenthemasterkeyisturnedON,powerisavailabletotheinstrument.ThemasterkeycannotberemovedwhenswitchedtotheONposition,andthelaserwilloperateonlywiththekeyinplace.2.3.2 LaserEnablingWhenthekeyswitchturnsonthesystempower,aLoginwindowappears.Loginpreventsunauthorizeduse.Followingsuccessfullogin,laseroperationisdisabledwhilethemicroprocessorchecksforbasicfaultconditionsandthesystemstabilizes.Afterthisperiod,theProcedurewindowwillappearontheDisplayPanel.2.3.3 LaserEmissionIndicatorLaseremissionisindicatedbyaredLASEREMISSIONindicatorontheDisplayPanel.2.3.4 ProtectiveHousingandSafetyInterlockTheLenSxLaserhasaprotectivehousingthatpreventsunintentionalaccesstolaserradiation.ThishousingshouldbeopenedonlybyaqualifiedLenSxrepresentative.2.3.5 LabelsAppropriatewarninglabelsaremountedinspecifiedlocationsonthelasersystemtoindicateconditionsunderwhichtheusercouldbesubjectedtolaserradiation(SeeSection10).
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 112.3.6 SafetyShutterMonitorDualsafetyshutters,closedunlessthesystemisintheTREATMENTmode,preventlaserradiationfromexitingtheinstrument.Shutterstatusiscontinuouslymonitored.Shouldamalfunctionoccur(i.e.asafetyshutteropensintheabsenceofafootswitchpress)thelaserconsoleisdisabledandamessagedisdisplayed.TheLenSxLasercannotbere‐enableduntilthefaultconditionhasbeencleared.2.3.7 FootswitchControlThefootswitchishousedinanindustrialgradeenclosureandcannotbeactivatedunlesstheLenSxLaserhascompletedallstepsinpreparationforlaserincision.Positionswitchesinthehousingarearrangedsuchthatthefootswitchpedalpositionisredundantlymonitored.2.3.8 RemoteInterlockConnectorThesystemisequippedwithanoutletfortheinterlockingofroomdoors.Amessageonthesystemdisplayappearswhentheremoteinterlockisnotconnectedproperlyorhasbeenbrokenbysomeaction,suchastheopeningofanoperatingroomdoor.LenSxrepresentativesshouldbecontactedforassistanceinestablishingaremoteinterlock.2.3.9 EmergencyOFFSwitchTheemergencyOFFswitchisaredbuttonlocatedonthefrontpaneloftheconsole.Whenpressed,theemergencyoffswitchshutsoffthemainsystempower.Thiscontrolshouldbeusedonlyintheeventofanemergency.IftheLenSxLaserisshutdown(bypressingtheEmergencyOffbuttonorbyalossofpower),thepatientmayberemovedfromunderthedeliverysystembyloweringthebedorbyactuatingthemanualgantryliftlocatedatthebaseofthedeliverysystemgantry.Torestartthesystemaftertheemergencyoffswitchisactuated,twisttheredemergencyoffbuttonuntilitdisengages;turnthekeyswitchtotheOFFpositionandreturnittotheONposition.Thesystemwillthenrebootnormally.FollowtheSystemStartupinstructioninsection4.6.1.2.3.10 LaserCoolingSystemTheLenSxLaserusesaninternalre‐circulatingcoolingsystemwhosefluidlevelsarecheckedduringpreventivemaintenance.Coolantlevelsareautomaticallymonitoredbythesystemandifalowcoolanterroroccurs,amessageisdisplayed.AnauthorizedLenSxservicerepresentativeshouldbecalledifacoolanterroroccurs.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 122.3.11 ManualGantryLiftThemanualgantryliftallowstheusertoraisethegantrymechanismupusingamanualscrew.Themanualliftknobisfoundatthebaseofthegantryafewinchesabovethefloor.Whenthesystemisunpowered,theknobisfreetoturn.2.3.12 PatientInterfaceRFIDEachLenSxLaserPatientInterfaceisinstrumentedwithanRFIDtag.TheRFIDtagauthenticatesthePatientInterfaceforusewiththeLenSxLaserandpreventsreuseorusebyunauthorizedpatientinterfaces.2.3.13 ConsoleFootbrakeWhenthelasersystemisinstalled,afootbrakeatthebackoftheunitpreventstheconsolefromrolling.Thefootbrakemustbeengagedduringtreatment.2.4 DeviceElectricalClassification Protectionagainstelectricshock:ClassIEquipment ProtectionagainstelectricshockPatientAppliedPart:TypeBF ModeofOperation:ContinuousOperation
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 133 SystemDescription3.1 IntroductionTheLenSxLaserSystemusesfocusedfemtosecondlaserpulsestocreateincisionsandseparatestissueinthelenscapsule,crystallinelensandcornea.Individualphotodisruptionlocationsarecontrolledbyrepeatedlyrepositioningthelaserfocus.Thelightpulseisfocusedintoasufficientlysmallspotinordertoachievephotodisruptionofthetissueinsidethefocus.Atinyvolumeoftissue,afewmicronsindiameter,isphotodisruptedatthelaserfocus.Thesurgicaleffectisproducedbyscanningthousandsofindividualpulsespersecondtoproduceacontinuousincisionortissueseparation.Thelocationofthetissuephotodisruptioniscontrolledbymovingthefocusofthelaserbeamtothedesiredsurgicaltargetlocation.Acomputer‐controlledscanningsystemdirectsthelaserbeamthroughoutathree‐dimensionalpatterntoproduceanincision.Thelaserpulsesaredeliveredthroughasterile,disposableapplanationlensandsuctionringassemblythatcontactsthecorneaandfixestheeyewithrespecttothedeliverysystem.3.2 SystemOverviewTheLenSxLaserisaCDRHCFR1040class3BandaIEC60825‐1class3Rlasersystemforocularsurgeryconsistingofthefollowingcomponents: alasersourcetoproducefemtosecondlaserpulses; anaimingdevicetolocalizespecifictargetsintheeye; anopticaldeliverysystemtopreciselydeliverlaserpulsestodesiredtargetsintheeye; computercontrollerstoperformclinicalprocedures; adisposablepatientinterfaceopticallycouplingtheeyetotheopticaldeliverysysteminordertopreventeyemovement.TheLenSxLaserisastand‐aloneunitrequiringnoexternalwaterorgasconnections.Thedeviceconsolehousesthelasersource,powersupplies,controlelectronics,coolingsystem,beamdeliverydevice,opticalcoherencetomography(OCT)device,videomicroscopeandcomputers.TheconsoleitselfisdesignedforuseinamedicalsettingmeetingUSandinternationalstandards(ETL)forelectromagneticemissionsformedicaldevices.Thelaserbeamandallcollateralradiationarecompletelyenclosedinsidetheconsole.TheKeyONswitchandEmergencyOffbuttonarelocatedonthefrontpaneloftheconsolewheretheyareeasilyidentifiedandaccessed.TheLenSxLaserSystemisshowninFigure3‐1.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 14Figure3‐1:LenSxLaserSystemAnall‐solid‐statelasersourceproducesakHzpulsetrainoffemtosecondpulses.Theamplifiedpulsetrainisroutedthroughabeammonitoringassemblycomprisedofenergymonitors,anenergyattenuatorandtheprimarysafetyshutter.Anopticalarticulatedarmdirectslaserlighttothedeliverysystemwhereasecondshuttercontrolsthebeam.Computercontrolledscanningmirrorsdirectthelightthroughabeamexpanderandthroughafocusingobjectiveontoaspotatpre‐determineddepthwithintheeye.Anopticalcoherencetomography(OCT)imagingdeviceandavideocameramicroscope(VM)areusedtolocalizespecifictargetsandtoviewthepatient’seye.TheLenSxLaserSystemusesasteriledisposablepatientinterfacethatattachestothedistalendofthefocusingobjective.Thepatientinterfaceisloweredtotheeyeuntilitcontactstheeye.Suctionthenholdstheeyeinposition.Onceparametersforthedesiredprocedureareselectedusingthesoftwareinterface,theprocedureisinitiatedbypressingthefootswitch.Althoughthesystemcomputercontrolsthelaseroperationduringtheincisionandlaserpulsepositioning,theproceduremaybestoppedatanytimebyreleasingthefootswitch.ThefollowingsectionsbrieflydescribethemajorcomponentsoutlinedinFigure3‐1.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 153.2.1 FemtosecondLaserEngineConsistentwithwell‐establishedfemtosecondlaserprinciples,thelaserengineusesaconventionalamplifiedlaserdesigninwhichpulseswithsufficientbandwidtharegeneratedbyanoscillator,amplifiedtohigherenergies,andfinallycompressedintimetofemtosecondpulseduration.Theoscillatorproducesfemtosecondlaserpulsesofnanojouleenergy.Thesepulsesaretemporallyexpandedbyapulse“stretcher”andarethendirectedintoadiode‐pumpedregenerativeamplifierwherethepulseenergyisincreasedasthepulsecompletesanumberofround‐tripswithintheamplifiercavity.Whenthepulseenergyreachesmicrojouleenergies,thepulseisswitchedoutoftheamplifiercavity.Amplifiedpulsesareroutedtoagratingcompressortotemporallycompressthepulsesbacktothefemtosecondrange.3.2.2 EnergyMonitorThebeamofcompressedpulsesfromthelaserthenenterstheenergymonitoringassembly.Acomputercontrolledenergyattenuatoradjuststhebeamenergytoprogrammedlevelsandenergymonitorsverifythebeamenergy.Aprimaryshutter,thatisnormallyclosedwhennotenergized,controlsthereleaseofthebeamfromtheenergymonitor.Electronichardwareclosestheshuttersintheeventthattheenergymonitorsreportanunexpectedorout‐of‐tolerancepulse.3.2.3 DeliverySystemThedeliverysystemfocusesthebeamoflaserpulsesontoafocusspotataprogrammedlocation.Uponexitingtheenergymonitor,thebeamentersanarticulatedarmthatterminatesatthedeliverysystem.Asecondshutteratthedeliverysystemcontrolsthelaserbeamthroughthedeliverysystem.Thebeamthenentersasetofcomputercontrolledscanningmirrorsthatscanthebeamintoabeam‐expandingtelescope.EachscannedpositionofthebeamcorrespondstoanX,Ylocationinthefocalplaneofthefocusingobjective.TheZpositionofthefocusedlaserspotiscomputercontrolledbyopticalzoomlenseslocatedinthebeamexpander.Theentiredeliverysystemismountedonamotorizedgantryattachedtothesystemconsoletoallowtheusertopositionthedeliverysystem.Thealignmentofthebeamthroughthedeliverysystemisautomaticallyverifiedbeforeeachprocedure.UserscanalsorequestthatanalignmentcheckbeperformedusingtheBeamSteeringselectionintheSystemChecksmenu.3.2.4 VideoMicroscopeThedeliverysystemincludesaSurgicalDisplaythatprovidesavideomicroscopeviewofthesurgicalfieldatalltimes.Illuminationofthefieldiscontrolledwithaninternalelectroniccontrollerandatouchscreeninterfacemountedontheconsole.Thevideoimageprovidesthe
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 16surgeonwithsurgicaldetailssuchasthepositionofthepupil.Thesurgeonobservesthevideoimagetoadjustandverifythepositionofthesurgicalpatternsduringprogrammingandperformanceoftheprocedure.3.2.5 OpticalCoherenceTomography(OCT)ImagingDeviceTheSurgicalDisplayalsoincludesanopticalcoherencetomography(OCT)basedimagingdevicethatassistsinlocalizingspecifictargetlocations.TheOCTconsistsofalowpowervisiblewavelengthlightsourcethatisscannedthroughoutthetransparentstructuresoftheanteriorchamberoftheeye.Lightscatteredfromocularstructuresandsurfaceswithintheeyeisanalyzedtoproducecrosssectionalimagesoftheeye’santeriorsegment.Varioussectionedimagesmaybeproduced,includingawidefieldlinescanoftheanteriorchamber,magnifiedcrosssectionsofthecorneaatthepointsofplannedincisions,andcircleandlinescansofthelensandcapsule.ThesurgeonusestheseOCTimagestoadjustandverifythepositionandorientationoftheselectedsurgicalpatterns.3.2.6 PatientInterfaceTheLenSxLaserusesasterile,disposablePatientInterface(Figure3‐2).ThePatientInterfaceiscomprisedofanapplanationlens,suctionringandtubing.Thesuctionringandcurvedapplanationlensareintegratedintoasinglepieceandmountedonthelaserdeliverysystem.ThePatientInterfaceismountedontothedistalendofthelaserfocusingobjectiveandservesasasterilebarrierbetweenthepatientandthelaser.Tubingisconnectedtoafilterandtoavacuumportonthelasersystem.ThePatientInterfacealsocontainsanintegratedpassiveRFIDidentificationdevice.TheRFIDidentifierissensedbyareaderlocatedinsidetheLenSxLaserSystemconsole.Thelensisloweredontothepatient’seyeuntilthecorneaisapplanated;suctionisthenactivated.Figure3‐2:LenSxLaserPatientInterface–(1)InterfaceConeandgripper;(2)tubing;(3)filterandRFID;(4)vacuumport.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 17Usingthegantryjoystickandvisualizationviathevideomicroscope,thecurvedapplanationcone(thatisattachedtothelaserdeliverysystem)isloweredtomakecontactontotheeye.Theapplanationforceindicatorisintheyelloworgreenzonewhenadequateapplanationforceisachieved,allowingthesurgeontoapplysuctionviatouchscreenactivationofaninternalpumptofixatetheeye.Graphicaloverlaysoftwaretools(referencetoalivevideoimageoftheeyeonthegraphicaluserinterface)areusedtoadjustthecentrationoftheprogrammedcuttingpatterntothedesiredposition.Whentheprocedureiscompleted,suctionisreleasedandthefocusingobjectiveislifted,removingtheapplanationlensfromthesurfaceoftheeye.Theapplanationlensandtubingarethendisposed. 3.2.7 SurgeonControlsThesurgeoncontrolstheLenSxLaserprimarilybyaconsoleinterfacecomprisedoftwodisplaymonitors(theDisplayPanelandSurgicalDisplay),akeyboard,atouchpadandatrackball.Parametersforphotodisruptionpatternandsysteminformationareenteredattheconsoleinterface.Thesystemsoftwareallowsthesurgeontoselectpatternparametersandtopreparethelaserfortreatment.Directlynexttotheconsoleinterfacearethemasterkeyswitch,whichisusedtostartthesystem,andtheemergencyOFFswitch.OtherimportantsurgeoncontrolsincludeanX,Y,&Zjoystickthatactuatethemotorizedgantrysupportingthedeliverysystem.Thejoystickisusedtoalignthedeliverysystemoverthepatientandtomakecontactwiththepatienteye.Asmalltouchscreenisusedtocontroltheutilitiesassociatedwiththedeliverysystem,includingtheilluminationcontrols,dockingcontrolsandvideomicroscopefocusingcontrols.Afootswitchallowsthesurgeontostartandstoplasertreatment.ThesurgeoninitiateslasertreatmentbyfirstnavigatingthesoftwareinterfaceuntilthesystemisREADYandstartsthetreatmentbypressingthefootswitch.Thesurgeoncaninterrupttheprocedureatanytimebyreleasingthefootswitch.Afterinterruption,thesurgeonrestartstheprocedurebypressingandholdingdownthefootswitchagain.Thelaserwillcontinuethetreatmentuntiltheprogrammedpatterniscomplete.3.2.8 SystemElectronicsTheLenSxLaserconsolecanbeconfiguredfor100V,120V,220‐240V,50/60Hzoperation.ACtoDCconverterssupplysystemelectronics,laserdiodesandthermoelectriccoolerswithlowvoltageDCcurrent.Themaximumpowerdrawislessthan1.2kW.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 18Electronicsensorsmonitorthepositionofthepatientinterfacewhenmountedontothedeliverysystem.Iftheapplanationlensisunlockedoroutofposition,hardwaresendsanerrortothecomputerandpreventstheprocedurefromstarting.Inaddition,sensorsauthenticatethepatientinterfaceviatheRFIDtagoneachpatientinterface.Acomputermonitorsandcontrolsthebeamenergy,repetitionrate,safetyshutters,footswitch,laserdiagnostics,thepositionofthescannersandthepositionofthescanningobjectivelens.Hardwaremonitorsthefunctioningofthecomputerandcomputersoftware.Ifanunsafeconditionoccurs,thesafetyshuttersareimmediatelyclosedandthesurgeonalerted.Inaddition,thesurgeonmonitorstheprocedurethroughthevideomicroscopeandcanhalttheprocedureatanytimebyreleasingthefootswitch.3.2.9 ConsoleChassisTheentirelaserconsoleisenclosedbyametalskin.Thesecoveringscannotberemovedwithoutspecialtools.Thelaserradiationisnotaccessibleoutsidetheconsolechassisuntilthetreatmentbeamexitsthesystematthepatientinterface.Theconsoleisdesignedforuseinasurgicalsetting,itiseasytoclean,andmeetsUSandinternationalstandardsforelectromagneticemissionsfrommedicaldevices.Thepatientappliedpartisclassifiedasfloating“BF”deviceandiselectricallyisolatedfromthesystemelectronicsandmainsinput.3.3 ProcedureOverviewTheLenSxLaserisindicatedforuseinpatientsundergoingcataractsurgeryforremovalofthecrystallinelens.Intendedusesincataractsurgeryincludeanteriorcapsulotomy,phacofragmentation,andthecreationofsingleplaneandmulti‐planearccuts/incisionsinthecornea,eachofwhichmaybeperformedeitherindividuallyorconsecutivelyduringthesameprocedure.TheLenSxLaserfocusesabeamoflowenergypulsesofinfraredlightintotheeye.Eachpulseofenergycreatesphotodisruptionofamicro‐volumeoftissueatthefocusofthebeam.Whenscanned,thebeamplacesindividualphotodisruptionsitesinacontiguouspatterntoformcontinuousincisions.Thespacingbetweenphotodisruptionsitesisprogrammedbytheuser.Atypicalincisionconsistsofseveraltensofthousandsmicro‐disruptions.Byprogrammingthesize,shapeandlocationofthescanningpattern,incisionsarecreated.Ananteriorcapsulotomyincisionconsistsofacylindricalcutstartingfrombelowthesurfaceoftheanteriorcapsuleandcontinuingthroughthecapsuleafewmicronsintotheanteriorchamber.Alensphacofragmentationincisionconsistsoftwoormoreverticallyorientedelliptical‐shapedplanesthatintersectatthecenterofthelens.Themaximumcuttingdepthshouldbeatleast
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 19500mabovetheposteriorcapsule.Thecutsproceedfromthedeepestpointandmoveanteriorly,endingbelowtheanteriorcapsule.Apartialthicknessorfullthicknesscutforcataractsurgeryconsistsofanarccutstartingfromthedesiredcornealthicknessandcontinuinganteriorlytowardsthecornealepithelium.Thesecutscanconsistof1,2or3planes.3.3.1 Pre‐OperativeStepsTheLenSxLaserusesaproprietarysteriledisposablePatientInterface.ThePatientInterfaceiscomprisedofanintegratedapplanationlens,suctionring,andtubingthatconnectstothesuctionportoftheLenSxsystem.Thepatientinterfaceismountedontothedistalendofthesystemfocusingobjectiveandservesasasterilebarrierbetweenthepatientandthelaser.SensorsintheLenSxconsoleauthenticatethepatientinterface.ThesurgeonusestheX,YandZjoystickcontroltocontacttheoperativeeye.Followingapplanation,mildsuctionisappliedviathetubinginordertostabilizetheeye.RefertotheInstructionforUsesuppliedwiththeLenSxLaserPatientInterfaceforpreparationandapplicationinstructionsforthePatientInterface.Thesurgeonobservesapplanationofthecorneausingthevideomicroscope,andthenappliessuctionwhenthecorneaisproperlyapplanated.TheSurgicalDisplaypresentsalivevideomicroscopeimageofthesurgicalfield.Graphicslaidovertheimageareusedtoprogramthelateralpositionoftheincision.Whenthelateralpositionisacceptable,OCTimagesappearontherightsideofSurgicalDisplay.Thesurgeonidentifiesthedepth,positionofthelensandcornealsurfacesusingtheOCTimages.GraphicaltoolsallowthesurgeontoprogramtheincisiondepthsontheOCTimages.Anteriorcapsulotomypatternsareprogrammedtocutfromatleast100micronsbelowto100micronsabovetheanteriorcapsule.Lensphacofragmentationpatternsareprogrammedtocutfromatleast500micronsabovetheposteriorcapsuletoatleast500micronsbelowtheanteriorcapsule.Partialandfullthicknesscornealincisionsareprogrammedasapercentageofcornealthicknessatthepositionthecutisbeingmade.Whenprogrammingiscomplete,thesystemperformsinternalchecksandnotifiesthesurgeonwhenthesystemisreadytofire.3.3.2 AnteriorCapsulotomyWhenthesurgeonpressesthefootswitch,themainshutterisopenedandthetreatmentbegins.Thetreatmentpatternbeginsasascannedcirclelocatedbelowthedepthoftheanteriorcapsule.Onceascannedcircleiscompleted,anewcircleisscannedafewmicronsabovethefirstcircle.Aseachcircleiscompleted,acylindricalincisioniscreated.Thepatternisautomaticallycompletedwhentheanteriorextentoftheincisionisreached.Whenthe
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 20patterniscompleted,thesystemautomaticallyclosesthemainshutterandnotifiesthesurgeon.3.3.3 PhacofragmentationWhenthesurgeonpressesthefootswitch,themainshutterisopenedandthetreatmentbegins.Thetreatmentpatternbeginsattheprogrammedposteriordepthasaninitialx‐shapedscaniscomplete,followedbysuccessivex‐shapedscanscreatedafewmicronsapart.Aseachscaniscompleted,thelateralextentofthescansisadjustedtofill‐intheellipticallyshapedvolume.Theresultistwoormoreverticallyoriented,ellipticallyshapedplanesthatintersectatthelenscenter.Thepatternisautomaticallycompletedwhentheprogrammedanteriordepthisreached.Whenthepatterniscompleted,thesystemautomaticallyclosesthemainshutterandnotifiesthesurgeon.3.3.4 CombinedTreatmentsTreatmentpatternsmaybecombinedbyselectingappropriatecombinationsofindividualpatterns.Notallcombinationsareallowed.Thesystemsoftwareenablesallowablecombinationsasthepatternselectionsaremade.Whenthesurgeonpressesthefootswitch,themainshutterisopenedandthefirsttreatmentbegins.Afterthefirstpatterniscompleted,thenextpatternbeginsautomatically.Whenthepatterniscompleted,thesystemautomaticallyclosesthemainshutterandnotifiesthesurgeon.3.3.5 Post‐OperativeStepsFollowingcompletionofthelaserprocedure,thesuctiontothePatientInterfaceisautomaticallyreleased.Thesurgeonthenusesthegantryjoysticktoliftthedeliverysystemfromthepatient’seye.ThePatientInterfaceisdisposedofasmedicalwaste.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 214 Controls,IndicatorsandDisplays4.1 DisplayPanel&KeyboardComputercontrolandsoftwareinterfacefunctionsareperformedusingthetouchpadandkeyboardinconjunctionwiththedisplaymonitors.Thesearemountedontheconsoletotheleftofthedeliverysystem.Theentirestationmaybeswiveledonitsmountingposttooptimizeviewingandcontrolaccess.Softwarefunctionsmaybeselectedbymovingadisplaycursorwiththetouchpadandclickingtheleftbutton.Selectingasoftwarefunctioncauseseitheracontrolfunctionoramenutoappear.Alphanumericdatamaybeenteredusingthekeyboard.4.2 SurgicalDisplayTheSurgicalDisplayismountedoverthedeliverysystem.ItdisplaysthevideomicroscopeandOCTimagesaswellasthegraphicaloverlaysforpatternpositioning.AtrackballisusedtocontroltheinputtotheSurgicalDisplay.4.2.1 VideoMicroscopeThevideomicroscopeimageisshownontheSurgicalDisplay.Overlaygraphicsofthesurgicalpatternsandcentrationmarksindicatetheprogrammedpositionofthetreatment.ThepositionandsizeofgraphicalmarkscanbeadjustedusingtheSurgicalDisplaytouchpad.Thelaserprocedureismonitoredliveusingthevideomicroscopeview.4.2.2 OpticalCoherenceTomography(OCT)DeviceTheOCTimagesareshownontheSurgicalDisplay.GraphicslaidovertheOCTimageindicatethedepthsofincisions.Thegraphicscanbevertically(axially)adjustedforpositionanddepthusingtheSurgicalDisplaytouchpad.AlthoughOCTimagesarenotupdatedinrealtime,OCTimagesmaybetakenafterthelensphacofragmentationtore‐adjustcapsulotomyorcornealincisions.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 224.3 DeliverySystemPanelThedeliverysystempanelislocatedonthefrontofthedeliverysystem,justbelowthevideomicroscope.Thispanelcontainsthefollowingcontrols:4.3.1 JoystickThedeliverysystemismountedonamotorizedgantrythatpositionsthedeliverysystem.Thejoystickcontrolsthegantryx‐y‐zpositioning:twistingthestickvariestheheightwhiledeflectingitcontrolsthelateralpositioning.Thedegreeoftwistordeflectioncontrolsthespeedofthetranslations.Thedirectionoflateralmotioncorrespondstothedeflectiondirection.Duringaprocedure,thejoystickcontrolsaredisabled.4.3.2 DeliverySystemTouchScreenAsmalltouchscreenpanelmounteddirectlyonthedeliverysystemisusedtomonitorandcontrolsomefunctionsofthedeliverysystem.Thecontrolsandindicatorsavailableonthetouchscreenincludeilluminationlevels,applanationforceindicator,videomicroscopezoomandfocuscontrols,andthefixationlighton/offswitch.Touchingthescreenallowstheusertoadjustorselectthecontrols.4.3.3 ApplanationIndicatorTheobjectivelensofthedeliverysystemisspring‐loadedtocontroltheapplanationforceexertedbytheobjective.ThedeliverysystemislowereduntilthePatientInterfacemakescontactwiththepatient’seye.Wheninitialcontactismade,theobjectivelensmovesupward.Sensorsinthedeliverysystemdetecttheobjective’spositionandapplanationforce.TheapplanationforceisindicatedontheDeliverySystemtouchscreen.Astheobjectiveislowered,theindicatedapplanationforceincreasesuntil,atapresetposition,themaximumapplanationforceisachievedandfurtherdownwardmotionceases.Onlymotionintheupwarddirectionisenabled.4.3.4 IlluminationandMicroscopeFocusTwoilluminationsourcesareavailableontheLenSxsystem:internaltothepatientinterfaceandexternalfromtheobjective.ExternalfieldandinternalfieldIlluminationlevelsarecontinuouslyvariedusingthedeliverysystemtouchscreen.ThecamerafocusforthevideomicroscopecanbechangedusingtheFocuscontrols.FocusingofthemicroscopeviewisusefulforvisualizationofthesubjecteyeduringDocking,PatternPositioningandLasertreatment.TheZoomandIlluminationcontrolsarelocatedontheDeliverySystemtouchscreen.Section6–ProcedureGuidedescribestheuseofthesecontrols.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 234.3.5 FixationLightAfixationlightisavailabletohelpapatientorienttheeyeduringtheDockingprocedure.TheswitchforthefixationlightisabuttonontheDeliverySystemtouchscreen.4.4 SystemPower4.4.1 MainInputSwitchAftertheLenSxSystemisconnectedtolinepower,electricalservicetotheconsoleisswitchedonwiththerockerswitchlocatedonthebackpaneloftheconsole.WhenswitchedON,powerisswitchedtothetransformersandtothelaserchiller.ThelaserengineandcomputersystemsarenotturnedON.4.4.2 KeySwitchLocatedonthefrontconsolepanel,thekeyswitchhastwopositions:“O”and“I”.RotatingthekeyfromOtoIturnsonthemainpowertothesystemcomputersandinitiateslaserwarmupandself‐checkingroutines.NormalshutdownofthesystempowerisaccomplishedbyrotatingthekeyonswitchfromItoO.4.4.3 EmergencyoffswitchLocatedontheconsolefrontpanel,theemergencyoffswitchisaneasilyaccessible,largeredbutton.Whenpressed,thesystempowerisimmediatelycutoff.Useoftheemergencyoffswitchshouldbelimitedtoemergenciesandnotfornormalshutdownofthesystem.4.5 FootswitchWhenthesystemisreadytocommenceatreatment,thesurgeonstartsthetreatmentbypressingthefootswitch.Thefootswitchisactuatedbyplacingafootinsidethehousingandpressingthehinged,spring‐loadedpedaluntilitcontactsthebottomofthefootswitch.ThefootswitchmustbeconnectedtotheconsolewhilethesystemisswitchedON.4.6 SoftwareControls4.6.1 SystemStartupWhenpowertotheLenSxLaserisswitchedon,theuserencountersthesystemaccessLogin.Followingsuccessfuluserlogin,awarm‐upandself‐checkphaseisinitiated.Statusofthe
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 24systemduringthewarmupandself‐testphaseisindicatedonthescreen.Attheconclusionofthewarmupphase,thesystemisreadyforuse.4.6.2 ProcedureProgrammingWindowFollowingsuccessfullogin,systemwarmupandself‐test,theProcedurewindowwillbedisplayed.SeeSection6–ProcedureGuideforprogramminginstructions.4.6.3 SystemChecksAllnon‐proceduresystemfunctionsareaccessedusingtheSystemChecksbutton.Selectingthisbuttonbringsupamenu,including: TheEnergyCalibrationoptionwillcausetheLenSxLasertoinitiateaprocedurethatwillverifythesystem’senergycalibration. SelectingBeamSteeringwillcausetheLenSxLasertoinitiatearoutinethatchecksandadjusts,ifnecessary,thealignmentofthelaserbeamintotheBeamDeliverySystem.4.6.4 UserRegistrationUserRegistrationallowsforaddingorremovingusers.4.6.5 ShutdownThesystemisshutdownbyturningthekeyswitchtothe“O”position.4.6.6 AboutTheAboutbuttonproducesawindowdisplayingcontactinformation,thesystemserialnumberandcurrentsoftwareversionnumber.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 254.7 Accessories&DetachablePartsThefollowingaccessoriesanddetachablepartsareusedwiththeLenSxLasers:ACCESSORY/PARTLOCATIONINSPECTION/REPLACEMENTSCHEDULEFootswitchRearPanelInspectedatinstallationFuse:3AG,FastActing,250V,15A(x2)RearPanelInspectedatinstallation/replacedasneededLenSxPatientInterfaceAttachestodeliversystemSingleuse,disposabledevice.Disposeasmedicalwaste.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 265 SystemRequirements5.1 ElectricalTheLenSxLaserisconfigurablefor100V/12A,120V/10A,220‐240V/7A,50/60Hz.Themaximumpowerdrawislessthanorequalto1.2kW.Thelinevoltageshouldbetesteduponinstallationtoensureproperoperationandshouldnotvarybymorethan+/‐10%fromnominal.ThelineandNeutralvoltageisfusedprotectedattherearpanel:3AG,FastActing,250V,15A.5.2 EnvironmentalAmbienttemperatureintheroomcontainingtheLenSxLasershouldremainbetween18°Cand24°C(65°Fand75°F).Theidealclimateshouldbebetween30%and40%humidity.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 276 ProcedureGuideTheLenSxLaserSystemallowsthesurgeontoprogramphacofragmentation,anteriorcapsulotomy,partialthicknessandfullthicknesscornealincisionsforcataractsurgery,individuallyorcombinedinasingletreatmentsession.Thepurposeofthissectionistoprovidestep‐by‐stepinstructionsintheuseoftheLenSxLasertoprogramandexecuteatreatmentsession.TheLenSxLaserSystemallowsthesurgeontotailorspecifictreatmentpatternsforeachpatient.Afterprogrammingatreatmentpatternanddockingthesystem,thesurgeonmayadjustthetreatmentpatternpositionusinginformationprovidedbythevideomicroscopeandOCTimages.Afterconfirmingthetreatment,thesurgeoninitiatesandmonitorsthelasertreatment.6.1 PreparationandTreatmentPlanningPriortotheactualtreatment,theLenSxLaserSystemisturnedonandusedtospecifyandplanthesurgicalprocedureusingthesystemsoftwareandgraphicaluserinterface.6.2 StartUp&ProcedureSelectionRotatethekeyonswitchfromthe“O”positiontothe"I"position.TheLenSxLaserSystemsoftwarewillbeinitiatedandtheDisplayPanelwilldisplaygraphicaluserinterface(GUI)information.UserinputstotheGUIaremadewiththetouchpadandkeyboardperipheraldevices.ThefirstscreendisplayedistheLoginscreen(Figure6‐1).Selectthe“doctor”option,enteravalidpassword.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 28Figure6‐1:Log‐inscreenfortheLenSxLaserSystemInthisfirstscreen,optionsforsavingorprintingtreatmentparametersmayalsobeselected.SavingorprintingparametersmaybeusefulastheinitialchoiceofparameterscanchangeduringthepatternpositioningstepstakenafterdockingandundervisualizationwiththevideomicroscopeandOCTimagingdevices.Aftersystemwarmupandself‐checkshavebeencompleted,theBiometricswindowwillappearontheDisplayPanel(Figure6‐2).Astatusindicatorlocatedontherightsideofthebiometricswindowdisplaysrelevantsystemstatus.Figure6‐2:Patientbiometricdatascreen
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 29WithintheBiometricsscreen,patientbiometricdatacollectedduringpre‐surgicalvisitsmaybeentered.Biometricdataincludesthelensthickness,andcentralcornealthickness.Otherpatientdataincludespatientandphysicianidentificationinformation.ThebiometricsdatamaybeusedtodefinethepositioningandorientationofthepatternsifsomeoralloftheOCTimageguidesarenotused.Forexample,somelensesmayhavehigh‐gradecataractsoropacitiesthatpreventvisualizationoftheposteriorcapsule.Intheeventofpoorvisualizationoftheposteriorcapsule,biometricdatafromA‐scanultrasoundmaybeusedtodefinetheextentoftheLenspatternforphacofragmentation.Oncethebiometricdatahasbeenenteredandverified,press“AcceptPre‐OpData”tocontinuewithtreatmentplanning.TheBiometricsscreenisnowreplacedwiththePatternSelectionwindowshowninFigure6‐3.ThePatternSelectionwindowdisplaysthepatientID,controlsforselectingandinitiatingprogrammingofproceduretypes,anabbreviatedviewoftheselectedparametersforthevariouscornealincisions,thesystemstatusindicatorbox,andtheDockbutton.Figure6‐3:PatternSelectionscreen.Fromthewhitepull‐downmenu,selectadefaultorpreviouslysavedpattern.UsingtheSelectbar,theusermayselectacuttingpatternfromtherowofbluebuttons.Theseselectionsdeterminethecombinationprogrammedtreatmentsforasinglesession.Whenselected,thebuttonishighlightedtoindicatethatselection.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 30Alternatively,previouslysavedpatternsmayberecalledusingtheSavedPatternpulldownmenulocatedbetweenthepatientIDinformationandtheSelectbar.PressingthearrowbuttonlocatedatthelowerrightcornerofthescreenreturnsthedisplaytotheBiometricsscreen.Figure6‐4:PatternSelectionscreenappearanceafterasavedpatternfilehasbeenrecalled.ThecorneaincisionsloadedfromthesavedfilearedisplayedinabbreviatedformintheQuickViewboxatthetoprightsideofthescreen.Afterselectingasavedpattern,orselectingappropriatepatternelementsfromtheSelectbar,parametersmaybespecifiedforeachpatternsegment.LocateddirectlybelowtheSelectbaristheProgrambar.EachProgrambarbuttoncorrespondstoaPatternbuttonfromtheSelectbarabove.SelectingoneoftheProgrambarbuttonsopenstheparameterwindowforthecorrespondingpatternelement.NotethatselectingparametersfrominsideaparticularProgrambarselectionwindowwillnotcausethePatterntobeenableduntilthecorrespondingSelectbarbuttonhasbeenpressed.AfteraPatternhasbeenloadedorselected,theCorneaIncisions–QuickViewfieldispopulatedwithparametersforthevariouscornealincisionsselected(upperrightsectionofFigure6‐4).EachPatternhasanumberofparametersassociatedwiththeparticulartypeofcutandtissue.ForeachPatternselected,theparametersmustbespecifiedorverifiedpriortoinitiatingthelasersurgicalprocedure.Inthefollowingsections,theprocessofspecifyingorprogrammingappropriatePatternsisoutlined.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 316.2.1 ProgrammingtheLensPatternTheLensPatternisusedtoperformphacofragmentationofthecrystallinelens.LensPatternsmaybespecifiedaseitherChoporCylinderpatterns.TheChopPatternisaseriesofverticalplanesarrangedradiallyinthelens,resemblingthespokesofawheelcenteredonthelens.TheCylinderPatternaseriesofverticallyorientedconcentriccylinderscenteredonthelens.WhentheLensbuttonhasbeenpressedundertheProgrambar,theLensPatternparameterscreenisdisplayed(Figure6‐5).User‐settableparametersaredisplayed,withthepresentvalueforeachparametershown.Usetheindividualparameterbuttonstoincrementordecrementeachvalue.Ontherightsideofthescreen,columnsofparametersmaybespecifiedforeithertheChoporCylinderpatterns.Figure6‐5:LensPatternparameterscreenSelectableparametersmaybegeometricorlaserscanningparameters.Geometricparametersincludetheanteriorcapsuledepth,theposteriorcapsuledepth,andthelensdiameter.LaserscanningparametersfortheLensscreenincludetheseparationofconsecutivelasershots(spotseparation)andthelaserpulseenergy.Theparametersdisplayeddependontheparticularpatternselected.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 32FortheLensPatternonly,OCTimagesofthepost‐lasertreatmentlensmaybesavedinordertoevaluatetheeffectoftheLensPatternonthepositioningofsubsequentpatternsonthecapsuleandcornealpatterns.IfthePost‐LensOCTimageisselected,thelaserprocedurewillhaltandprovideanopportunityfortheusertore‐positionthesubsequentpatternsbeforecompletingtheprocedure.Selectappropriateparameters.PresstheAcceptandSavebuttonsatthebottomoftheLensPatternparameters.Adialogwindowforenteringafilenametobesavedisdisplayed.PreviouslysavedparametersfilesmayalsoberecalledandloadedbyselectingtheParamFilesbutton.ThesystemsoftwarereturnsthedisplaytothePatternSelectionscreen.6.2.2 ProgrammingtheCapsulotomyPatternTheCapsulePatternisusedtoperformananteriorcapsulotomyofthecrystallinelens.Theanteriorcapsulotomyiscreatedbyscanningacylindricalshellextendingfromapositioninthelensvolumethroughthecapsuleandintotheanteriorchamber.Thecylindricalscanpatternpenetratesthecapsuleinacompletecircularshape.TheCapsulePatternparameterscreenisusedtoselecttreatmentparameters.Theseincludethecapsulotomydiameter,theestimatedcapsuleposteriordepth,theestimatedcapsuleanteriordepth,thecapsuledeltaupdistance,andthecapsuledeltadowndistance.AsintheLensPattern,laserenergy,spotandlineseparationdistancesmaybespecified.ThesurgeoncanelecttoperformthecapsulotomycuteitherbeforeoraftertheLensPatternisexecutedbyselectingtheCapsulotomyFirstbutton.TheCapsulePatternscancanalsobeselectedtobegineitherattheposterior(bottom)oranterior(top)endofthescanpatternbytogglingtheScanStartparameter.Aftertheinformationhasbeenenteredcorrectly,presstheAcceptandSavebuttonsdisplayedatthebottomoftheCapsuleIncisionparameterscreen.ThesystemreturnstotheSelectPatternsscreen.6.2.3 ProgrammingthePrimaryIncisionPatternThePrimaryIncisionPatternisusedtocreatecornealincisionsforpenetratingkeratoplastyorforcataractsurgery.ThegeometryofthePrimaryIncisionPatternisconstructedfromone,twoorthreeangledplanesarrangedalongadefinedarcatthecornealperiphery.Theplanesareconnectedtocreateasingleopening.ThePrimaryIncisionPatternmayrepresentacompletelypenetratingcutorapartialthicknesscut.Partialthicknesscutscanbecreatedandlateropenedmanuallybythesurgeon.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 33PrimaryIncisionPatternsbeginattheprogrammedmaximumposteriordepthandprogressanteriorlyuntiltheprogrammedanteriordepthisreached.Depthsareexpressedasapercentageofthecornealthickness.Cornealthicknesscanbedefinedpre‐operativelyorbyusingtheOCTimage.(Figure6‐6)Figure6‐6:PrimaryIncisionPatternparameterscreenThePrimaryIncisionPatternparameterscreenallowstheusertospecifypatterngeometryandlaserscanningparameters.Thebasicshapeisanarccutattheperipheryofthecornea.Userscanselectone,twoorthreeplaneincisions.Thedepthofeachplaneissetwiththe%PosterDepthparameter.TheSideCutAngleisanglethattheplanemakeswiththecornealanteriorsurface.TheplanesmaybeoverlappedtoensurecompletecutsusingtheAntOverlapparameter.Aftertheinformationhasbeenenteredcorrectly,presstheAcceptandSavebuttonsdisplayedatthebottomofthePrimaryIncisionPatternparameterscreen.ThesystemreturnstotheSelectProceduresscreen.6.2.4 ProgrammingtheSecondaryIncisionPatternTheSecondaryIncisionPatternisusedtocreateacornealincisionandissimilartothePrimaryIncisionPattern.SecondaryIncisionPatternsmaybeusedtoaidcataractsurgery.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 34TheSecondaryIncisionPatternasingleangledplanelocatedalonganarconthecornealperiphery.Thepatternisdefinedbythedistanceofthearcfromthelimbus,theradiusofcurvatureofthearc,andtheangularlocationofthearc.TheSideCutAngledefinestheanglethattheplanarcutmakeswithrespecttothecorneasurface.TheSecondaryIncisionPatternisspecifiedasapenetratingorapartialthicknesskeratoplastycutbyselectingtheappropriatevalueforthe%PosteriorDepthparameter.TheamountofovercutabovethecornealanteriorsurfacecanbespecifiedwiththeAnteriorOverlapparameter.Afterallparametershavebeenentered,presstheAcceptandSavebuttonsdisplayedatthebottomofthescreen.ThesystemreturnstotheSelectProceduresscreen.6.2.5 ProgrammingtheArcuateIncisionPatternsArcuatecornealcutscanbemadeusingtheArcuateIncisionPattern.ArcuateIncisionPatterncutsaremadeinthecornealperiphery,andarearc‐shapedpartialthicknesscuts.ArcuateIncisionPatterncutsstartatauser‐programmedposteriordepthandprogressintheanteriordirection.Thepatterndepthchosenusingthe%PosteriorDepthbuttonandisexpressedasapercentageofcornealthickness.ChoosingtheDiameterparameterdeterminesthecirclediameterwhereinthearccutslie.EitheroneortwoarcsmaybeselectedusingtheTwoArcs/OneArcbuttonnearthebottomofthescreen(seeFigure6‐7).Thedepthofthearccutsisspecifiedwiththe%PosteriorDepthparameter.TheBeforeCorneaIncisionsbuttoncanbeusedtodeterminewhetherthepatternisexecutedbeforeorafterothercornealincisionpatterns.Afterallparametershavebeenentered,presstheAcceptandSavebuttonsdisplayedatthebottomofthescreen.ThesystemreturnstotheSelectProceduresscreen.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 35Figure6‐7:PrimaryIncisionPatternparameterscreen6.2.6 CombiningPatternsPatternsmaybecombinedinvariouswaystoachieveadesiredsurgicalprocedure.SelectappropriatepatternbuttonsinthePatternSelectionscreenallowsthesurgeontocreatethedesiredpatterncombinations.However,noteverycombinationofpatternsisallowable.Toviewtheallowedcombinationsinanypatternscreen,selecttheSelectCutsbutton.Atableofcombinationsisshowninawindow(Figure6‐8below).Thiswindowalsoshowsthecurrentlyselectedcombinationofpatterns.Duringlasertreatment,thepatternswillbeexecutedinasequencethatgenerallyproceedsfromthemostposteriorcutstothemostanteriorcuts.Insomecases,theorderofcutsmaybespecifiedwithinthepatternparameterscreen.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 36Figure6‐8:Allowedpatterncombinations.6.2.7 CompletingPatternSelectionOnceallthepatternselectionandparameterprogramminghasbeencompleted,presstheSavebuttonlocatedintheCornealIncisions–QuickViewboxatthetopofthePatternSelectionscreen.ToproceedtoDocking,presstheDockbuttonlocatedatthefarrightsideoftheSelectbarchoices.TheTreatscreenwillbethenbedisplayed(Figure6‐9below)
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 37Figure6‐9:DisplayPanelshowingtheTreatscreenimmediatelyafterpressingtheDockbuttoninthePatternSelectscreen.TheTreatscreenindicatesthesystemstatusintheboxattheupperrightandisusedtoinitiatesuction.6.3 PreparingthePatientInterfaceWhenallpatternselectionsandparameterchoicesarecomplete,thesystemisreadytodockwiththepatient.AfterDockinghasbeensuccessfullycompleted,theplannedtreatmentpatternsareorientedandadjustedwithrespecttothetargetedoculartissuesinthePatternPositioningprocess(Section6.5)TheLenSxLaserSystemusesaproprietarydisposablePatientInterface(PI).ThesterilePIiscomprisedofanapplanationlens,suctionring,andtubing(seeFigure3‐2).OpenthepackagingandplacethePIontoasterilefield.InspectthecomponentsofthePIfordamageordisconnection.GraspthecontactlensmountofthePI.Placethecontactlensmountonthedeliverysystemlaseraperture;twistthecontactlensmountuntilitlocksintoplace.GraspthevacuumtubeandinsertitontothevacuumportontheLenSxLaserSystem.ThePIalsocontainsanintegratedpassiveRFIDidentificationdevice.TheRFIDidentifierissensedbyareaderlocatedinsidetheLenSxLaserSystemconsole.TheTreatscreenstatusindicatorPIisdisplayedwhenthePIhasbeenproperlyinstalledandtheRFIDtransponderdetectsavalididentificationcodeonthePI.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 38OncethePIhasbeenproperlyinstalledontheLenSxLaserSystem,thepatientshouldbepreparedforDocking.6.4 DockingPlacethepatientinasupinepositionunderthedeliverysystemandPatientInterface.ApplyatopicalantiseptictotheeyepriortoDocking.UsethejoysticktocontrolthegantryandroughlyalignthePatientInterfacetotheeye.Whilethepatient’seyeislocatedatdistancesgreaterthan1centimeterfromthePI,usetheZoombuttonontheDeliverySystemTouchscreentoadjustthevideomicroscopemagnification.TouchtheexternalilluminationbarontheDeliverySystemTouchscreentosetthedesiredlevelofIllumination.Touchthefixationlightbuttontoswitchonthepatientfixationlight.InstructthepatienttomaintainfixationonthelightduringtheDockingprocess.UsethejoysticktocenterandlowerthegantryuntilthePatientInterfacecontactstheeye.TheDeliverySystemTouchscreenmonitorstheapplanationforcecontinuously.TheTreatscreenwillshowtheCONTACTstatusindicatorwhentheforcesensorintegratedinthedeliverysystemdetectsaninitialapplanationforce.Graphicalindicatorsshowboththedesiredrangeofforceandthemeasuredforce(seeFigure6‐10below).Usethejoysticktoadjusttheapplanationforcetothedesiredrange.SwitchoffthemicroscopeZoom.TheSurgicalDisplaynowshowsonlytheinternalviewoftheeye.Touchtheinternalilluminationbartosetthedesiredlevelofillumination.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 39Figure6‐10:LeftimageshowsthemainDeliverySystemtouchscreendisplay.Setilluminationlevelsbytouchingthewideverticalbars.RightimageisdisplayedafterselectingVideo.AdjustingthecamerafocuszoomallowsgoodvisualizationbeforethePIcontactsthecornea.P1‐P4arefocalpositionpre‐sets.Theapplanationforceindicatorisontherightsideofeveryscreen.Theapplanationforceiscorrectwhenthewhiteellipseisinthegreenrange.Figure6‐11:SurgicalDisplayduringDocking.ThedashedlinesrepresentcentrationguidesandareusedtopositionthedeliverysystemandPIwithrespecttothepatienteye.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 40UsetheSurgicalDisplaytoverifythatthePIisnominallycenteredonthecornea,slowlyadjustingthejoystickasnecessarytocenterthePIonthecornea.OncethePIhasbeenproperlycentered,pressthePISUCTIONcontrolbuttonlocatedatthelowerleftcorneroftheTreatscreen.AlowvacuumlevelappliedtothePIgentlyfixatestheeyetothecontactlens.Thejoystickcontrolisnowinactiveandthegantrycannotbemoveduntilthesuctionisreleased.TheSurgicalDisplayscreenthenchangestoshowalivevideoimageoftheapplanatedeyeandanindicationthattheOCThasbeenactivated.TheLenSxLaserSystemisnowreadyforpositioningoftheselectedpatterns.6.5 PatternPositioning6.5.1 OverviewOncethedeliverydeviceandPatientInterfacehasbeendockedontothepatient’seye,theselectedandprogrammedpatternsmaybere‐positioned.TheVideoMicroscopeandOCTareusedtoguidethepositioningsteps.TheSurgicalDisplayoverlaystheselectedpatternsontothevideomicroscopeandtheOCTimages.Theoverlaypatternsareshownastheoutlinesandcentersofthepatterns,alongwithgraphicaltoolsformanipulatingandpositioningthepatterns.TheLenSxLaserSystemsoftwareassiststheuserinthepositioningprocess.Ateachstep,theuser’snextactionishighlightedandappropriatebuttonsandviewsareenabled.AdjustmentsmadebytheoperatorwiththeaidofvideomicroscopeandOCTimageguidesareusedtoupdatethepatternpositioninginformationstoredbytheLenSxLaserSystem.Thegeneralorderofpatternpositioningandcentrationadjustmentsisasfollows: Docking/PISuction Limbuscentration Primaryandsecondaryincisionpatternalignment Lenscentration Capsulotomyandlensdiameteradjustment Arcuateincisionangleanddiameteradjustment Capsuledepthandcuttingrangeadjustments Capsule/lenspositioningalignment Corneathicknessmeasurements(primary,secondaryandarcuateincisions)Somepatternpositioningstepsmaybeomitted,dependingonthepatternsselected.TheprogressionofpatternpositioningstepsisshownbychangesinthestatusindicatorslocatedatthebottomoftheSurgicalDisplay.Highlightedactionbuttonsindicatetherequirednextstepsfortheuser.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 41Atanypointinthepatternpositioningprocess,selectingtheactionbuttonwithanarrowallowstheusertoreturntotheprevioussteportoexitthepatternpositioningprocess.6.5.2 VideoMicroscope,OCTImageGuidesandPatternGraphicsDuringpatternpositioning,theSurgicalDisplayshowsalivevideoimageoftheeyeonthetopleftsideandOCTimagesonthetopandbottomrightside.Onthebottomofthedisplay,thestatusindicatorandactionbuttonsaredisplayed.GraphicaloverlaysontheSurgicalDisplayandOCTimagesindicatetheplannedincisionpatternsandtheirrelationshiptotheoculartissues.Solidlinesinthegraphicaloverlaysrepresenttheouterboundariesofthepatterns.DashedlinesrepresentcentrationorpositionalinformationrelativetothevideomicroscopeandOCTimages.Controlpointsaresmallsolidcirclesthatrepresentuser‐adjustableparameters.Pointthecursorandclickonacontrolpointtomakeitactive.Activecontrolpointscanbemovedbydraggingthecursortothedesiredlocation.Asecondclickonthecontrolpointdeactivatesthecontrolpoint.Activecontrolpointsareadifferentcolorthaninactivecontrolpoints.Onlyonecontrolpointisactiveatanytime.6.5.3 LimbusCentrationAfterPISuctionhasbeeninitiated,limbuscentrationlinesareoverlaidontheSurgicalDisplay.NoOCTscansareusedinthispositioningstep.Thelimbuscentrationcontrolpointsinthevideomicroscopedisplayareactive.Placethecursoronthecontrolpoint.Clickanddragthecontrolpointtocenterthelimbuscentrationlinesonthelimbus.Clickagainonthecontrolpointwhencentrationiscomplete.Thecontrolpointindicatorchangesappearancetoindicatecompletionofthisstep.SeeFigure6‐12.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 42Figure6‐12.Limbuscentration.Redarrowpointstocontrolpoint(bluedot)usedtopositiontheguides(whitedashedlines)onthelimbus.Inthisexample,thePrimary(heavyyellow),Secondary(orange),Arcuate(white),Capsule(pink)andLens(lightyellow)patternshavebeenselected.6.5.4 PrimaryandSecondaryIncisionAlignmentIfPrimaryorSecondaryIncisionPatternsareselected,thenextstepinpatternpositioningistheradiallocationofthesepatterns.ThepatternlocationsaredisplayedonthevideomicroscopeimageontheSurgicalDisplay.NoOCTscansareusedinthispositioningstep.AcontrolpointforthePrimaryIncisionPatternisactive.Movethecontrolpointbyclickinganddragging.TheSecondaryIncisionPatternissimilarlypositionedafterthePrimaryIncisionPatterncontrolpointisdeactivatedwithasecondmouseclick.AftercompletingthePrimaryandSecondaryIncisionPatternpositioning,anactionbutton(eitherScanorLimbusCentration)willcausetheLenSxLaserSystemtoverifythattheadjustedpatternpositionsareconsistentwithotherpatternsandparameters.Iftheverificationstep
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 43resultsinanerror,adialogboxwillalerttheusertocorrectthepatternpositioningbeforeallowingthenextstep.Figure6‐13:PrimaryIncisionPatternpositioning.Redarrowpointstocontrolpoint(bluedot)usedtomovethePrimaryIncisionPattern(heavyyellowshapeatright)alongtheradialdirection.SecondaryIncisionPatternpositioningproceedsinthesamemannerafterthecontrolpointforthePrimaryIncisionPatternhasbeendeactivatedwithasecondclick.6.5.5 LensAlignmentIflensorcapsulepatternsareselected,theLensCentrationactionbuttonwillappear.Iflensorcapsulepatternsarenotselected,thelensalignmentstepwillnotbeperformed.PresstheLensCentrationactionbutton.SeveralcontrolpointsmayappearontheVideoMicroscopeimage,dependingonthecombinationofpatterns.NoOCTscansareusedinthispositioningstep.ThecontrolpointstobeadjustedmayincludetheLensPatterncenter,theCapsulePatterndiameter,theLensPatterndiameter,andtheArcuateIncisionPatterndiameter.Selectand
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 44activateeachcontrolpointinturn,andadjusttheLencenterandpatterndiametersasappropriate.UsersshouldverifythattheLensPatterndiameterfallswithinthe8mmdiameterlensalignmentdashedcircle.Ifnecessary,theArcuateIncisionPatternmayberotatedineitherdirectionuptoamaximumof20degreesfromtheoriginallyprogrammedvalue.Holddowntheclockwise(CW)orcounterclockwise(CCW)buttontoattainthedesiredrotationangle.Figure6‐14:ControlpointsdisplayedintheLensPatternpositioningstep.Notalladjustmentsmaybeshowndependingonthepatternsselected.Arrow1=LensPatterncentration,Arrow2=CapsulePatterndiameter,Arrow3=LensPatterndiameter,Arrow4=ArcuateIncisionPatterndiameter.Whenallpositionshavebeenadjusted,theLensstatusbarchangesindicatingcompletionofthisstep.6.5.6 CapsuleDepthAdjustmentAftercompletingtheLenspositioningsteps,thenextpositioningadjustmentsaretherangesforcapsuleincisions(ifCapsulePatternhasbeenselected).AcirclescanOCTimageofthelensand1243
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 45capsuleisdisplayedthetoprightareaoftheSurgicalDisplay.ThecirclescanisperformedalongtheCapsulePatterndiameterasdefinedonthevideomicroscopeimageoftheeye.Figure6‐15:RoughadjustmentoftheCapsulepatternrange.Controlpointscanbemovedupordown.ThesolidlinerepresentpreviouslyprogrammedvaluesfortheDeltaUpandDeltaDownTwohorizontaldashedlinesareoverlaidontheOCTimage.Controlpointsforthedepthrangeadjustmentandtwoothersolidlineswithoutcontrolpointsareshown.Thenumericvaluesofthepreviouslyprogrammedupdelta/downdeltavaluesaredisplayed.TheAnteriorDepthcontrolpointcanbemovedverticallyfordepth.Itcanalsobemovedhorizontallytoindicatetheangularpositionofthehighpointofthecapsule.ThisAnteriorDepthcontrolpointhasshortdashedlinetoindicatetheabilitytomoveithorizontally.MovetheAnteriorDepthcontrolpointtotheminimumdepthofthecapsule.MovethePosteriorDepthcontrolpointstothemaximumdepthofthecapsule.ThesolidDeltaUp/DeltaDownlineswillmovewiththedashedhorizontallinesassociatedwitheachcontrolpoint.TheDeltaUpandDeltaDownvaluesthemselvesdonotchange.Thepositionsofthemaximumandminimumcapsulepositionsdeterminetheaxisoftiltofthelens.PressZoomInwhendone.Anenlargedimageisshownandthecontrolpointsallowforfineradjustmentofthecapsuledepthrange.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 46Figure6‐16:FineadjustmentoftheCapsulepatternrange.TheAnteriorDepthandPosteriorDepthcontrolpointsareproperlypositioned.PressingAcceptstorestheadjustmentsandenablesthenextCapsulerangeadjustmentstep.WhentheCapsulerangeadjustmentsarecomplete,presstheAcceptbutton.TheLenSxLaserSystemsoftwarechecksthattheadjustmentsarevalidforthepatternsselected.Iftheadjustmentscheckissuccessful,thevideomicroscopeimageshowsadashedlineindicatingthetiltaxisofthelens.TheCapsuleRangestatusindicatorchangestoindicatecompletion,andthenextpatternpositioningstepisenabled.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 47Figure6‐17:CompletionofCapsuleRangeadjustments.Thephaseangleassociatedwiththecapsuletiltisindicatedbythedashedline(redarrow).6.5.7 LensDepthAdjustmentTheCapsulepositionadjustmentallowstheusertoadjustthepositionoftheLenspatternstomatchthesurfacesandvolumeofthelens.Theadjustmentsaremadeforthedepthscorrespondingtotheposteriorandanteriorlimitsofthecapsuleandlenslocation.AlinescanOCTimagealongthetiltanglepreviouslydefinedisdisplayedwithcontrolpointsfortheAnteriorCapsuleDepth,thePosteriorCapsuleDepth,andthemaximumallowabledepth.Thecontrolpointscanonlybeadjustedvertically.IftheCapsulepatternisenabledbuttheLensPatternisnot,nocontrolpointswillbeavailable.Forthiscombinationofpatternselections,theCapsulepositioningstepisonlyusedfordisplayingstoredresults.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 48Theinitialvaluesforthecontrolpointdepthscorrespondtopre‐programmedvaluesandvaluesstoredfrompreviouspatternpositioningsteps.Figure6‐18:AdjustmentsfortheCapsulePositionstep.AnteriorCapsuledepthandPosteriorCapsuledepthcontrolpointsareadjustedvertically.Themaximumallowabledepthisrepresentedbyafixeddashedline(MaxDepth).TheOCTlinescanissuperimposedwiththediametersoftheCapsulePattern(pink)andthevolumeoutlineoftheLensPattern(yellowlinesandcurves).Twosolid(purple)verticallinesegmentsaredisplayedrepresentingtheCapsulotomyPattern.ThecapsulotomydiameterrangeisrepresentedbytheseparationofthelinesandtheCapsuledepthrangeisrepresentedbythepositionandverticalheightofthelines.TheLenstreatmentvolumeisrepresentedbyanupperarc,alowerarc,andtwoverticallines(allinyellow).ThedistancebetweentheleftandrightverticallinesrepresentsLensdiametervaluestoredintheLimbusCentrationpositioningstep.TheupperarcmatchestheAnteriorLensCurvatureandthelowerarccorrespondstoPosteriorLensCurvature.Bothcurvaturevaluesaredefaultvaluesoruser‐suppliedvaluestakenfromtheLensparametersscreen.ThedifferencebetweentheAnteriorCapsuleDepthandthetopoftheupperarcisequaltotheLensAnteriorOffsetfromtheLensparametersscreen.ThedepthdifferencebetweenthePosteriorCapsuleDepthandthebottomofthelowerarcisequaltotheLensPosteriorOffsetfromtheLensparametersscreen.AdjusttheAnteriorCapsuleDepthcontrolpointtoapositioninsidetheanteriorcapsuleapex.TheAnteriorCapsuleDepthnumericvalueandtheLensPatterntreatmentvolumeareupdated
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 49asthecontrolpointischanged.AdjustthePosteriorCapsuleDepthtoapositioninsidetheposteriorcapsuleapex.ThePosteriorCapsuleDepthnumericvalueandtheLensPatterntreatmentvolumeareupdatedasthecontrolpointischanged.WhentheCapsulePositionadjustmentsarecomplete,presstheAcceptbutton.TheLenSxLaserSystemsoftwarechecksthattheadjustmentsarevalidforthepatternsselected.Iftheadjustmentscheckissuccessful,thedisplayshowstheVideoMicroscopeimage.TheCapsulePositionstatusindicatorchangesappearancetoindicatecompletion.Ifcornealincisionpatternshavebeenselected,thefinalpatternpositioningstepofCornealThicknessisenabled.Ifnot,presstheAcceptAllbuttontoproceedwithtreatment.6.5.8 CornealPrimaryandSecondaryIncisionsThicknessAdjustmentIfcornealincisionsareselected,thelaststepinpatternpositioningisadjustingthecornealthicknessandcornealincisiongeometryparameters.ThePrimaryIncisionPatterngeometryandthecornealthicknessareadjustedfirst.PresstheScanbuttonatthebottomoftheSurgicalDisplaytoproceed.AnOCTimageofthecornealregionofthePrimaryIncisionPatternisdisplayed.TheOCTimageappearsatthebottomrightcorneroftheSurgicalDisplay.AnX‐Zcross‐sectionofthePrimaryIncisionPatternisdepicted.ThisrepresentationoftheincisionisreferredtoastheTunnel.TheTunnelmaybecomposedof1,2or3separatelinesegmentsrepresentingtheplanesspecifiedinthePrimaryIncisionPatternparameterprogrammingstep.ThreecontrolpointsthatadjusttheEpithelial,EndothelialandTunnelEndarealsodisplayed.TheEpithelialandEndothelialcontrolpointsareusedtosetthepositionsoftheanteriorandposteriorcornea.TheTunnelEndcontrolpointisusedtopositiontheendofthetunnel.TheEpithelialcontrolpointcanonlybemovedalongtheverticallydashedline.TheEndothelialcontrolpointcanbemovedperpendicularlytothecorneaalongthenormaldashedline.TheTunnelcontrolpointmaybemovedfreelyinthehorizontalandverticaldirections.MovinganyofthethreecontrolpointscausesthegraphicalfeaturerepresentingthePrimaryIncisionPatterntomoveaswell.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 50Figure6‐19:CompletedadjustmentofPrimaryIncisionPatterntunnelparameters.PressingtheCapsPositionbuttonallowstheusertoswitchbetweenCapsulePositionadjustmentsandCornealThicknessadjustments.PresstheAcceptbuttontosavetheparametersandproceedtothenextstep.Thenumericvaluesofthetunnellength(distancefromEpithelialcontrolpointtoTunnelcontrolpoint),effectivetunnellength(sumofdistancesofeachplanemakingupthetunnel),cornealthicknessaredisplayed.TheanglesandthepercentdepthofcorneaforeachplanemakingupthePrimaryIncisionPatternarealsodisplayed.Thesenumericvaluesareupdatedasthecontrolpointsaremoved.ThecornealthicknessvalueasdeterminedbysettingtheEpithelialandEndothelialcontrolpointsisalsousedfortheSecondaryIncisionPattern.AsthePrimaryandSecondaryIncisionPatternsarepositioned,theCapsulePositionactionbuttonisdisplayedtoalloweasyswitchingbetweenpositioningmodes.PresstheAcceptbuttonwhenthePrimaryandSecondaryIncisionPatternpositioningiscomplete.TheLenSxLaserSystemsoftwareperformsavalidationcheckonthepatternparameters.Anerrormessageisdisplayediftheparametersareinvalid.Theparametersmustbecorrectedbeforeproceeding.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 516.5.9 ArcuateIncisionThicknessAdjustmentsIfanArcuateIncisionPatternisselected,theArcuateThicknessactionbuttonappearsafterpressingtheAcceptbutton.SelectingtheArcuateThicknessbuttoninitiatesanOCTscanofthecornealregionforthearcuateincision.ThezoomedimageofthePrimaryArcuateIncisionpatternisdisplayedonthetoprightportionoftheVideoMicroscopedisplay.IftheSecondaryArcuateIncisionpatternisenabled,thezoomedimageoftheSecondaryArcuateIncisionareaisdisplayedonthebottomrightportionoftheSurgicalDisplay.EpithelialandEndothelialcontrolpoints,similartothoseinthePrimaryandSecondaryIncisionPatternsabovearedisplayed.TheEpithelialcontrolpointcanonlybemovedalongthedashedverticallineinFigureXXbelow.TheEndothelialcontrolpointismovedalongthedashedlinenormaltothecornea.Asthecontrolpointsaremoved,thenumericvalueofthedistancebetweenthem,representingthecornealthickness,isdisplayedandupdated.Movethecontrolpointstoproducethedesiredcutpositionanddepth.RepeatforboththePrimaryandSecondaryArcuateIncisionPatterns,ifnecessary.Thecornealthicknessvalueusedisthesmallerofthetwoadjustedthicknesses.WhentheArcuateIncisioncornealthicknessadjustmentsarecomplete,presstheAcceptbutton.TheLenSxLaserSystemsoftwareperformsavalidationcheckonthepatternparameters.Anerrormessageisdisplayediftheparametersareinvalid.Theparametersmustbecorrectedbeforeproceeding.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 52Figure6‐20:LineOCTguideandcornealthicknessadjustmentsforArcuateIncisionPatterns.FigureshowsPrimaryArcuateIncisionandcontrolpoints(notshownistheSecondaryArcuateIncision).Thecontrolpointsareadjustedtothedesiredpositionandthicknessforthearcuatecuts.PreviousViewswitchestothelastdisplayedscreen.PressingtheAcceptbuttonstorestheadjustedvaluesandreturnsthedisplaytothePatternPositioningScreen.6.6 ConfirmationIfallpositioningstepshavebeencompleted,theAcceptAllactionbuttonisactive(Seefigure6‐21below).PresstheAcceptAllbutton.AsummaryofalteredpatternparameterswillbeshownontheDisplayPanel.ReviewthesummaryandselecteitherRerunOCTtorepeatthesequenceofpositioningstepsorselectApplytoPatienttoproceedtotreatment.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 53Figure6‐21:Oncethepatternpositioningprocesshasbeensuccessfullycompleted,presstheAcceptAllbuttontobeginthetreatment.6.7 TreatmentAftertheAcceptAllbuttonhasbeenselected,treatmentisenabled.TheSurgicalDisplayshowsalivemicroscopevideoimage,alineOCTimageoftheanteriorchamber,andacircleOCTimageofthelensandcapsule.Graphicaloutlinesoftheselectedpatternsareoverlaidoneachoftheseviews.AmessageisdisplayedontheDisplayPanelindicatingthatthebeamscannershavebeenmovedtothestartingpositionfortreatment.Theestimatedlasertreatmenttimeinsecondsisdisplayed.TheTreatbuttonisnowenabled.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 54Figure6‐22:DisplayPanelwhensystemisreadyfortreatment.Treatbuttonisenabledandtheproceduretimeisindicatedintheblueprogressbar.PresstheTreatbutton.ThetreatmentdialogwindowisdisplayedinthemiddleoftheTreatmentscreen.TheOCTimagesareoverlaidwithprogressindicatorbars.Initially,theseverticalindicatorsareunfilled.Whenreadytobegintreatment,pressandholdthefootswitch.Releasingthefootswitchduringtheprocedurewillimmediatelyhalttreatment.Treatmentcanberesumedbypressingthefootswitchagain.Duringlasertreatment,aredlaseremissionmessageisshownontheDisplayPanel.Procedureprogressmaybemonitoredwiththefollowingindicators: verticalprogressbarscontinuouslytracktheprogressofeachincision adisplayofthepatternselections adisplayoftheestimatedremainingproceduretimeinseconds alivevideocameraimageofsurgicalfieldDuringtreatment,monitorthesurgicalprogressonthevideomonitor.Ifanincorrectpatternoccurs,halttheprocedurebyreleasingthefootswitch.Theproceduremaythenbecontinued.Alternatively,atraditionalcataractsurgicalproceduremaybeperformed.Intheeventofpowerfailureresultinginaninterruptedprocedure,removethepatientinterfacetubefromthevacuumporttoreleasetheeyefromsuction.Graspthedeliverysystemobjectiveandraiseit1to2inchestosafelyremovethepatientfromthesurgicalfield.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 55Ifatanytimeduringthecombinationprocedurethesurgeonwishestohalttheprocedure,thefootswitchmaybereleased.Figure6‐23:DisplayPanelandSurgicalDisplayduringtreatment.TheOCTimagesareoverlaidwithgraphicalindicatorsforthepatternsandcompletionprogressbars(lowerrightcornerofrightimage).6.8 ProcedureCompletionAmessagewillbedisplayedindicatingthecompletionoftheprocedure.TheSurgicalDisplaycontinuestoshowalivevideoimageoftheeye.TheDisplayPanelreturnstothebiometricsscreen.Releasethefootswitchatthistime.Completionoftheprocedurede‐activatesthefootswitchandclosesthemainlasershutter.Vacuumisautomaticallyhaltedandtheeyeisreleasedfromsuction.Rotatethejoystickonthecontrolpanelcounter‐clockwisetoraisethedeliverydeviceandsafelyremovethepatientfromthesurgicalfield.Unlock,removeanddiscardthePatientInterface.DiscardthePatientInterfaceasmedicalwaste.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 567 CalibrationandAlignmentCalibrationoftheLenSxLasershouldbeperformedbytrainedLenSxpersonnel.However,thefollowinginternalcalibrationproceduresareavailabletotheuser.7.1 EnergyCalibrationTheLenSxLaserperformsalaserenergycalibrationduringsystemstartup.Auser‐requestedcalibrationcanbeperformedatanytimebyselectingEnergyCalibrationintheSystemChecksmenu.Notoolsarerequired.Useoftheconsoleisdisableduntilthecalibrationhasbeencompleted.7.2 BeamSteeringTheLenSxLaserautomaticallyperformsabeamsteeringcheckpriortoeachprocedure.Thischeckensuresthatthelaserbeamisoptimallyalignedintothedeliverysystem.UserscanalsorequestthatthischeckbeperformedusingtheBeamSteeringselectionintheSystemChecksmenu.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 578 ServiceandMaintenanceToensurecontinuousoperationoftheLenSxLasersystem,preventivemaintenanceserviceshouldbemadeeverythreemonthsbyanauthorizedLenSxservicerepresentative.OnlytrainedLenSxrepresentativesshouldperformunpacking,installation,andservicingoftheLenSxLaser.CoversarenottoberemovedbyanyoneotherthanLenSxpersonnel.AccidentalcontactwiththehighvoltageelectricalcircuitsintheinterioroftheLenSxLaserconsolemayresultinseriousinjuryordeath.Ocularexposuretocollimatedbeamscontainedintheconsoleinteriorcanproduceretinaldamage.TheLenSxLaserusesaclosed,internalre‐circulatingcoolingsystemwhosefluidlevelsarecheckedduringpreventivemaintenance.Coolantlevelsareautomaticallymonitoredbythesystemandifalowcoolanterroroccurs,amessageisdisplayed.AnauthorizedLenSxservicerepresentativeshouldbecalledifacoolanterroroccurs.TheLenSxconsoleisdesignedforuseinasurgicalsetting.Theoutersurfacesoftheconsolemaybewipeddownwithacleandampclothifnecessary.Amilddisinfectingagentmaybeused.Theconsoledoesnotrequirefurthersterilization.Accidentfluidspillsonthedeliverysystemopticsmaybelightlywipedusinganalcoholswab.TheLenSxLaserisdesignedforusewithaLenSxLaserPatientInterface.ThePatientInterfaceistheonlycomponentthatcontactsthepatient.AllusedPatientInterfacesmustbeproperlydisposedasmedicalwaste.8.1 TransportandStorageContactLenSxrepresentativestomove,transportorstoretheLenSxLaser.Thetransportandstoragetemperaturesshouldnotexceedoperatingtemperatureandhumidityspecifications.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 589 TroubleShootingBelowisaguidetosomepossibleproblems,withthesymptoms,possiblecausesandcorrectiveactions.Ifaparticularconditionisnotlistedhere,itisadvisedthataLenSxauthorizedservicerepresentativebecontactedforconsultation.Table9‐A:LenSxLaser–TroubleshootingGuideSymptomPossiblecauseCorrectiveactionLaserconsoledoesnotstartup.FuseblownatsystemrealpanelReplacefuselocatedatthelowerrearpanel.LaserconsolewillnotproceedtothetreatmentstageFootswitchisactuatedReleasefootswitchParametersnotselectedEnterrequiredfieldsSystemfaulthasoccurredContactLenSxrepresentativeDoorsafetyinterlockhasdisabledlaserconsoleCloseoperatingsuitedoors,checkinterlockconnectionsLaserconsolewillnottreatwhenenabledFootswitchnotconnectedConnectfootswitchFootswitchnotfullyactuatedCompletelyactuatefootswitchLaserconsolewillnotenergizeuponstart‐upPowercorddisconnectedConnectcordFootswitchnotconnectedConnectfootswitchCircuitbreakertrippedResetbreaker,checkelectricalserviceSystemelectricalfaultContactLenSxrepresentativeLaserbeamhaltsduringtreatmentDoorsafetyinterlockhasdisabledlaserCloseoperatingsuitedoors,checkinterlockconnectionsFootswitchnotfullyactuatedMaintainfootswitchactuationduringprocedureFaultconditionContactLenSxrepresentativeFixationcannotbeachievedormaintainedSuctionnotpresentRe‐applysuctionringSuctiontubingfailureReplacesuctionringImproperapplanationorimpropercouplingofthesuctionringassembleorapplanationlensRe‐positiondeliverysystemandre‐applanatecornea.PatientmovementImmobilizepatient
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 59SymptomPossiblecauseCorrectiveactionOperatingfieldnotproperlyobservablethroughmicroscopeApplanationlenscontaminatedReplacedisposablePatientInterface.PoorilluminationorpoorfocusAdjustilluminationorfocuscontrols.MicroscopeopticallymisalignedVerifypositioningofmagnificationknob.LasertissueeffectnotapparentduringtreatmentApplanationlenscontaminatedordamagedReplacedisposablePatientInterface.ApplanationlostorvacuumintegrityhasbeenlostRepositionsuctionringandfixate.Re‐positiondeliverysystemandre‐applanatecornea.LaseroutputblockedContactLenSxservicerepresentative.LaseroutputmisalignedLaseropticalmalfunctionContactLenSxservicerepresentative.ProcedureincompleteApplanationlostorvacuumintegrityhasbeenlostresultinginaninterruptedprocedureRepositionsuctionringandfixate.Re‐positiondeliverysystemandre‐applanatecornea.Repeatphacofragmentationtreatmentatthesamecenteredpositionandusingsameparametersasappropriate.Repeatcapsulotomytreatmentatthesamecenterpositionandusingslightlylargerdiameter.LaseroutputblockedInspectbeampath.Allow1hourbeforeretreatment.LasersourcemisalignedContactLenSxservicerepresentative.RetreatwhenLenSxLaserisrepaired.MisalignedbeamdeliverydeviceLossoflinepowerReleasetheeyefromsuction.Graspthedeliverysystemobjectiveandraiseit1to2inchestosafelyremovethepatientfromthesurgicalfield.Treatmentgeometryincorrectx‐yscanningunitfailureContactLenSx servicerepresentative.RetreatwhenLenSxLaserisrepaired.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 6010 Labels10.1 ConsoleLabelsWarninglabelsarefoundontheLenSxLasertodenotespecifichazards.Observelabelwarningsatalltimes.TheLenSxLaserislabeledinaccordancewithrequirementsforallmedicaldevicesaswellaswithrequirementsforlaserproducts.Table10‐A:WarningLabelsusedwiththeLenSxLaserLabelLabelNameIdentificationLabel(100V)IdentificationLabel(120V)
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 61LabelLabelNameIdentificationLabel(220‐240V)LaserApertureProtectiveHousing,Class4ProtectiveHousing,Class3BSurgical Laser Beam Maximum Output: 0.5WPulse Duration: <800fsEmittied Wavelength: 1030nmIEC 60825-1:2007 Class 3B Laser Device82-0004 Rev. ALaserWarningSurgicalBeam
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 62LabelLabelNameOCT Laser Beam Maximum Output: 3.0mWEmittied Wavelength: 820-880nmIEC 60825-1:2007 Class 3R Laser Device10 CFR 1040.10 Class 3B Laser Device82-0006 Rev. AOCTBeamLaserWarningHighVoltageHighVoltage(internal)EmergencyStop
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 6311 SystemSpecificationsSystemParameter SpecificationsLasertypeFemtosecondInfraredlaserModeFundamental(TEM00)Coneangle0.20sr(±0.05sr)halfangleLaserpulsewidth600‐800fs(±50fs)Centrallaserwavelength1030nm(±5nm)Maximumpulseenergy15µJ(±1.5µJ)OCTDeviceWavelength820–880nm(±5nm)3.0mW(±0.2mW)maximumpowerRemoteinterlockIncludedinsystemInputvoltageConfigurable100V/12A,120V/10A,220‐240V/7A,50/60HzMaximumElectricalLoad ≤1.2kWExternalFuse(x2)3AG,FastActing,250V,15AConsoledimensionsConsolefootprint24”(W)x30”(L)x48”(H)Beamdeliverydevice8”(W)x23”(L)x20”(H)BeamdeliverydeviceheightMin28.1inches(floortoapplanationlens)Max41.7inches(floortoapplanationlens)Consoleweight1055lbsAmbientoperatingtemperature18°Cto24°C(65°Fto75°F)
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 6412 WarrantyInformationAlconLenSxInc.(AlconLenSx)warrantsthattheLenSxLaser(the“Equipment”)andsoftwarewillconformtothepublishedproductspecificationsofAlconLenSxandbefreefrommaterialdefectsinmaterialsandworkmanshipforthefirstyearofcontinuousservice.AnAlconLenSxserviceandsupportcontractbetweenAlconLenSxoranAlconaffiliateandtheendusermustbemaintainedatalltimes.AlconLenSxwillrepairorreplaceatnochargeanyEquipmentorsoftwarefounduponexaminationbyAlconLenSxtobedefectiveduringthewarrantyperiod.Thiswarrantyissubjecttothefollowingexclusions,exceptions,andlimitations:a)expensessuchaslabororotherexpensesduetodelaysorinabilitytorenderanyservice;b)correctionofoperatorproblemsrelatedtoenvironmentalconditionsbeyondthecontrolofAlconLenSx;c)repairandmaintenancenecessitatedbyuser‐induceddamage,neglect,misuse,orimproperoperationoftheEquipmentorsoftware;d)modificationorconnectionofotherequipmenttotheEquipmentorsoftwarewithouttheexpresswrittenauthorizationofAlconLenSx,suchauthorizationwhichmaybewithheldatAlconLenSx’ssolediscretion;e)subleaseoruseofEquipmentbyanyoneotherthantheend‐user'squalifiedandtrainedpersonnel;f)useforanyprocesses,procedures,experiments,oranyotheruseforwhichtheEquipmentisnotintendedforuseorapprovedforusebytheFoodandDrugAdministration(FDA);g)supplies,devices,orelectricalworkexternaltotheAlconLenSxEquipmentorsoftware;andh)repairsduetotheuser'sfailuretoperformanyroutinemaintenance,whichistheresponsibilityoftheuser.AlconLenSxisnotresponsibleandwillchargetheuserforrepair,replacement,ormaintenancecausedbyuser‐induceddamage,neglect,misuse,improperoperation,accident,fire,water,vandalism,unauthorizedequipmentattachedtotheEquipment,orunauthorizedmodificationofEquipmentorsoftware.WarrantydoesnotextendtoanyEquipmentorsoftwarenotprovidedbyLenSx.THEFOREGOINGWARRANTYISINLIEUOFANDEXCLUDESALLOTHEREXPRESSORIMPLIEDWARRANTIES,ARISINGBYOPERATIONOFLAWOROTHERWISE,ANDNOOTHERWARRANTIESEXIST,INCLUDING,WITHOUTLIMITATION,THEIMPLIEDWARRANTIESOFMERCHANTABILITY.FURTHERMORE,ALCONLENSXDOESNOTWARRANTTHATTHEOPERATIONOFTHESOFTWARESHALLBEUNINTERRUPTEDORERRORFREE.INNOEVENTWILLALCONLENSXBELIABLEFORANYINCIDENTALORCONSEQUENTIALDAMAGES,EXPENSES,LOSTPROFITS,OROTHERDAMAGESARISINGOUTOFTHEUSEORINABILITYTOUSETHEEQUIPMENTANDSOFTWARE,EVENIFALCONLENSXHASBEENADVISEDOFTHEPOSSIBILITYOFSUCHDAMAGE.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 6513 AbbreviationsandTerms13.1 GeneralAbbreviationsANSIAmericanNationalStandardsInstituteCDRHCenterforDeviceandRadiologicHealth(FDA)DFUDirectionsforUseFDAFoodandDrugAdministration(UnitedStates)LEDLightEmittingDiodeNOHDNominalOpticalHazardZone13.2 TermsApplanation:flatteningofcorneaFemtosecond:measureoftime;1fs=10‐15seconds,or0.000000000000001secondsPicosecond:measureoftime;1ps=10‐12seconds,or0.000000000001seconds13.3 SymbolsManufacturerEuropeanRepresentative
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 6614 NominalOpticalHazardDistance(NOHD)TheNOHDisdefinedaccordingtoAmericanNationalStandardsInstituteZ136.1‐2000,“AmericanNationalStandardforSafeUseofLasers.”TheNOHDiscomputedintermsoftheMaximumPermissibleExposure(MPE)allowedontotheeye.FortheLenSxLasertheNOHDcalculatedusingthisstandardisveryshortduetothesmallpulseenergiesemittedbythelaser.Thepracticalconsequenceisthatoperatorsandsupportpersonnelarenotatendangeredbyopticalradiationnormalandroutineoperationofthelaser.AnyserviceoperationrequiringtheremovalofanycoversorshieldsontheconsolewillrequireeyewearofOD≥5atawavelengthof1030nm.OnlyauthorizedLenSxservicerepresentativesshouldattempttoremoveconsolecoversortoservicetheLenSxLaser.ThestepsrequiredtocalculatetheNOHDaccordingtoZ136.1‐2000(referredtohereafteras“theStandard”)aredescribedbelow.TheStandarddescribesthecalculationofMPEaccordingtothreerulesandutilizestheprescribedMPEtocomputetheNOHD.Rule1:Single‐pulseMPETable5aoftheStandardliststhesingle‐pulseMPEforalaserofwavelength1030nmandasinglepulseexposureof600fsas721.5 10 J/cmSP CMPE C  .(1)FromTable5oftheStandard,CC=1sothatMPESP=1.510‐7J/cm2.TocomputetheNOHD,considerthefigurebelow.ThisfigureissimilartoFigureB6oftheStandard.Afterthefocal,lightfillsaconeofhalf‐angleandilluminatesaplaneatadistancer.Thefluence,F,observedonthesurfaceisdr=rNOHDFigure14‐1:Geometryforcalculationforpossibleocular
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 67222.tanEFdEr(2)HereEisthemaximumenergydeliveredbyasinglepulse.TheNOHDiscomputedbyreplacingthefluencewiththeMPESPderivedaboveandsolvingforr.122()tanNOHDSPErMPE.(3)FortheLenSxLaser,themaximumemittedenergyis15µJandθ=is14.5°.TheresultingNOHDusingRule1is21.8cm.Rule2:AveragePowerMPEforThermalandPhotochemicalHazardsAccordingtoTable5aoftheStandard,theaveragepower,MPEforanexposureof10sis3 2 2( 0.700)10 W/cm where10 .AVG C CMPE C C  .(4)Usingλ=1.030mm,theaveragepowerMPEisMPEAVG=4.5710‐3W/cm2.InordertocomputetheNOHD,considerthefigureusedinRule1andcomputetheirradianceasfollows:222.tanAVGAVGPIdPr(5)TheNOHDiscomputedbyreplacingtheirradiancewiththeMPEAVGin(5)andsolvingforr.122()tanAVGNOHDAVGPrMPE.(6)FortheLenSxLaser,theaveragemaximumpowerofthelaseris500mWat33kHzandθ=is14.5°.TheresultingNOHDusingRule2is22.8cm.Rule3:Multiple‐pulseMPEforThermalHazardsSection8.2.3oftheStandarddefinestheMPEforthisruleas, /SP PMPE pulse MPE C,whereMPESPiscomputedfrom(1),andCP=n–1/4wherenisnumberofpulsesemittedduringa10sexposure.Duringa10sexposureoftheLenSxLaser:
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 68n=3.3105;CP=0.042;MPEMULT=6.3010‐9J/cm2.TheNOHDiscomputedbyreplacingMPESPinequation(3)withMPEMULT.TheresultingNOHDusingRule3is106cm.SinceRule3providesthemostconservativevaluesofNOHD,thereportednominalopticalhazarddistanceis106cmfortheLenSxLaser.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 6915 DeclarationofComplianceGuidanceandmanufacturer’sdeclaration–electromagneticemissionsTheLenSxLaserSystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheLenSxLasershouldassurethatitisusedinsuchanenvironment.EmissionstestComplianceElectromagneticenvironment‐guidanceRFemissionsCISPR11IEC60601‐1‐2ClassATheLenSxLaserSystemusesRFenergyforitsinternalfunctionandanRFIDdevicefordetectionofavalidPatientInterface.TheRFIDisalowpowersinglefrequencydevicethatcomplieswithFCCandinternationalstandardsforintentionaltransmitters.Therefore,itsRFemissionsarelowandarenotlikelytocauseanyinterferenceinnearbyelectronicequipment.Thisdevicecomplieswith47CRF15FederalCommunicationsCommissionRules(FCC)forradiofrequencydevices.(1)TheLenSxLaserdoesnotcauseharmfulinterference,and(2)thisdevicemustacceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.ChangesormodificationsnotexpresslyapprovedbyAlconLenSxInc.canvoidtheuser’sauthoritytooperatethisdevice.ConductedemissionsCISPR11IEC60601‐1‐2ClassATheLenSxLaserSystemissuitableforuseinallestablishmentsotherthanthosedirectlyconnectedtothepubliclow‐voltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.HarmonicemissionsIEC61000‐3‐2ClassAVoltagefluctuations/flickeremissionsIEC61000‐3‐3Complies
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 70Guidanceandmanufacturer’sdeclaration–electromagneticimmunityTheLenSxLaserSystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheLenSxLaserSystemshouldassurethatitisusedinsuchanenvironment.ImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment‐guidanceElectrostaticdischarge(ESD)IEC61000‐4‐2±6kVcontact±8kV±6kVcontact±8kVFloorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.OperatorDisplayPaneldemonstratedsusceptibilitytoESDat4kV(andabove)whenappliedtothemetalarmandmetalmountbracketsattherearofthemonitorassembly.Thesusceptibilityresultsintransientflickerofthedisplaymonitor.Performanceandsafetyarenotaffected.RadiatedEMFieldIEC61000‐4‐3Range80MHz–2.5GHz3V/mRange80MHz–2.5GHz3V/mElectro‐Magneticfieldsshouldbeatlevelscharacteristicofatypicallocationinatypicalcommercialorhospitalenvironment.Donotusecellphones,pagers,orradiofrequencydevicesofanykindinthesameroomastheLenSxLaser.Electricalfasttransient/burstIEC61000‐4‐4±2kVforpowersupplylines±1kVforinput/outputlines±2kVforpowersupplylines±1kVforinput/outputlinesMainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.SurgeImmunityIEC61000‐4‐5±1kVdifferentialmode±2kVcommonmode±1kVdifferentialmode±2kVcommonmodeMainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.ConductedDisturbancesIEC61000‐4‐6Range0.15–80MHz3(VRMS)Range0.15–80MHz3(VRMS)Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.Powerfrequency(50/60Hz)magneticfieldImmunityIEC61000‐4‐83A/m3A/mPowerfrequencymagneticfieldsshouldbeatlevelscharacteristicofatypicallocationinatypicalcommercialorhospitalenvironment.
LENSXLASERSYSTEMOPERATOR’SMANUAL 80‐0001Rev.A 71Guidanceandmanufacturer’sdeclaration–electromagneticimmunityTheLenSxLaserSystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheLenSxLaserSystemshouldassurethatitisusedinsuchanenvironment.ImmunitytestIEC60601testlevelCompliancelevelElectromagneticenvironment‐guidanceVoltagedips,Interruptions&FluctuationsIEC61000‐4‐11Dips>95%for10ms‐60%for1000ms‐30%for500msInterruptions>95%for5secFluctuationsUNOM+10%15minUNOM–10%15minDips>95%for10ms‐60%for1000ms‐30%for500msInterruptions>95%for5secFluctuationsUNOM+10%15minUNOM–10%15minMainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.ItisarequirementthattheuserpowerstheAlconLenSxLaserSystemwithaUPS.TheUPSmusthaveenoughback‐upcapacityforaminimumof5minutesatsystemfullload.TheratingfortheUPSshouldbeaminimumof1400WattsNOTE:UNOMistheA.C.mainsvoltagepriortoapplicationofthetestlevel

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