Alcon LenSx 8065998162 LenSx Laser User Manual

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User Manual

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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)

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.



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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.

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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.



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OPERATOR’SMANUAL 

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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

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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

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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.

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OPERATOR’SMANUAL 

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

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).

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OPERATOR’SMANUAL 

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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.

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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

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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.



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80‐0001Rev.A 14

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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.

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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

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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.

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

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.



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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

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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

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

X

ASER

YSTEM



PERATOR

’

S

ANUAL

 

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Figure6‐8:Allowedpatterncombinations.

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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)

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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

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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.

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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.

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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

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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 

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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 

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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 

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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

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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: 0.5W

Pulse Duration: <800fs

Emittied Wavelength: 1030nm

IEC 60825-1:2007 Class 3B Laser Device

82-0004 Rev. A

LaserWarning

SurgicalBeam

LENSXLASERSYSTEM

OPERATOR’SMANUAL 



80‐0001Rev.A 62

LabelLabelName

OCT Laser Beam Maximum Output: 3.0mW

Emittied Wavelength: 820-880nm

IEC 60825-1:2007 Class 3R Laser Device

10 CFR 1040.10 Class 3B Laser Device

82-0006 Rev. A

OCTBeam

LaserWarning

HighVoltage

HighVoltage(internal)

EmergencyStop



LENSXLASERSYSTEM

OPERATOR’SMANUAL 

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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



72

1.5 10 J/cm

SP C

MPE 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



r=rNOHD



Figure14‐1:Geometryforcalculationforpossibleocular

LENSXLASERSYSTEM

OPERATOR’SMANUAL 



80‐0001Rev.A 67



tan







(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.



()tan

NOHD

rMPE















.(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 C

MPE 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:

2

tan

AVG







(5)



TheNOHDiscomputedbyreplacingtheirradiancewiththeMPEAVGin(5)andsolving

forr.



()tan

AVG

NOHD

AVG

rMPE















.(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 P

MPE 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



Alcon LenSx 8065998162 LenSx Laser User Manual

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