Iridex IRIS Medical OcuLight SL User manual

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
IRIS Medical®
OcuLight®SL/SLx
Operator Manual
PN 13099D-EN

©2005IRIDEXCorporation.Allrightsreserved.PublishedintheUSA.

ExceptwiththeexpresswrittenpermissionofIRIDEX,thecontentsofthismanualmay
notbecopiedinwholeorinpart,orreproducedinortransmittedtoanyothermedia.
Allpermissiblecopies,includingthosetranslatedintoanotherlanguage,mustcontain
thesameproprietaryandcopyrightnoticesaspublishedwiththeoriginalmanual.

Themanualisprovidedforinstructionaluseandwhileeveryefforthasbeenmadeto
ensuretheinformationisaccurate,theinformationcontainedwithinissubjecttochange
withoutnotice.

IRIDEX,theIRIDEXlogo,IRISMedical,EndoProbeandSmartKeyareregistered
trademarksofIRIDEXCorporation.TruFocus,DioPexy,G‐Probe,Symphony,CW‐
Pulse,MicroPulseandLongPulsearetrademarksofIRIDEXCorporation.Allother
trademarksarethepropertyoftheirrespectiveowners.

TheOcuLightSLandSLxaremanufacturedusingoneormoreofthefollowingpatents:
5,085,492;5,088,803;6,540,391;6,733,490.

IRIDEXCorporation,1212TerraBellaAvenue,MountainView,California,94043‐1824,
USA
OcuLight SL/SLx Operator Manual
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Table of Contents
AboutIRIDEX…………………………………………………………………………………...................5
Overview………………………………………………………………………………………………5
ContactInformation…………………………………………………………………………………5
AbouttheOcuLightSLandSLx………………………………………………………………………..6
Introduction……………………………………………………………………………………………6
PotentialAdverseEffects……………………………………………………………………………6
IndicationsforUse…………………………………………………………………………………….6
AbouttheComponents………..…………………………………………………………………………7
PackingList……………………………………………………………………………………………7
ComponentDescriptions……………………………………………………………………………8
PositioningtheSL/SLx……………………………………………………………………………………9
TemperatureandHumidityConsiderations……………………………………………………….9
ElectricalRequirements………………………………………………………………………………9
PhysicalLocationConsiderations………………………………………………………………….10
RearPanelConnections…………………………………………………………………………………10
RequiredConnections……………………….………………………………………………………10
FrontPanelControlsandConnections………………………………………………………………..11
FeatureDescriptions…..……………………….……………………………………………………..11
OperatingBasics………………………………………………………………………………………….13
ConnectingaDeliveryDevice………………………………………………………………………13
TurningOntheSL/SLx………………………………………………………………………………13
TurningOfftheSL/SLx………………………………………………………………………………14
EmergencyStop………………………………………………………………………………………14
CW‐PulseMode…………………………………………………………………………………………..15
Overview………………………………………………………………………………………………15
SelectingTreatmentSettings………………………………………………………………………..16
LongPulseMode…………………………………………………………………………………………17
Overview……………………………………………………………………………………………..17
UsingLongPulseMode……………………………………………………………………………..17
MicroPulseMode…………………………………………………………………………………………19
Overview……………………………………………………………………………………………..19
UsingMicroPulseMode……………………………………………………………………………..20
CustomizingtheSL/SLx………………………………………………………………………………..22
AdjustingAimingBeamIntensity…………………………………………………………………22
AdjustingLIOIllumination…………………………………………………………………………22
AdjustingtheVolume………………………………………………………………………………22
UserPreferencesMenu………………………………………………………………………………23
Troubleshooting…………………………………………………………………………………………24
OcuLight SL/SLx Operator Manual
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Maintenance………………………………………………………………………………………………26
CleaningtheConsole…………………………………………………………………………………26
CleaningtheFootswitch…………………………………………………………………………….26
ChangingACLineFuses…………………………………………………………………………….27
VerifyingthePowerCalibration……………………………………………………………………27
VerifyingthePowerCalibration……………………………………………………………………28
WarrantyandService…………………………………………………………………………………….30
SafetyInformation……………………………………………………………………………………….31
GeneralMeasures…………………………………………………………………………………….31
EyeSafetyFilters…………………………………………………………………………………….31
LaserSafetyEyewear………………………………………………………………………………..32
DeterminingWhenSafetyEyewearisRequired………………………………………………….32
SafetyFeatures……………………………………………………………………………………….33
Labeling……………………………………………………………………………………………………36
BackPanel…………………………………………………………………………………………….36
ManufacturingDateandSerialNumber…………………………………………………………..37
GroundingLabel……………………………………………………………………………………..37
FootswitchLabel…………………………………………………………………………………….37
GuidetoSymbols……………………………………………………………………………………38
ProductSpecifications…………………………………………………………………………………39
TreatmentBeam……………………………………………………………………………………..39
AimingBeam…………………………………………………………………………………………39
General………………………………………………………………………………………………..39
AppendixA:Table201perIEC60601‐1‐2……………………………………………………………41
AppendixB:Table202perIEC60601‐1‐2…………………………………………………………….42
AppendixC:DecontaminationCertificate…………………………………………………………..43
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OcuLight SL/SLx Operator Manual
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About IRIDEX
Overview
IRIDEXCorporation,headquarteredinMountainView,California,isaleading
worldwidemanufacturerofsolid‐statemedicallasersystems.TheCompanydevelops,
manufacturesandmarketslasersystems,deliveryinstrumentationandrelated
accessoriesfortheophthalmology,dermatologyandveterinarymarkets.
Theophthalmicsolid‐statelasersystems,marketedunderthebrandnameIRISMedical,
areusedtotreatavarietyofoculardiseases,includingthethreeleadingcausesof
irreversibleblindness:maculardegeneration,diabeticretinopathyandglaucoma.
IRIDEXisanFDAregisteredmedicaldevicemanufacturerandcomplieswithcurrent
QSR,ISO13485andMDDregulationsandguidelines.
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Contact Information
TechnicalServiceandSupport:ContactIRIDEXviaphone:
650.940.4700

Orbyemail:
[email protected]

ToplaceanOrder:CallTollFreeinNorthAmerica:
800.388.4747

OutsideofNorthAmerica:
650.940.4700

MailingAddress:IRIDEXCorporation
1212TerraBellaAvenue
MountainView,California94043‐1824USA

Internet:www.iridex.com

AuthorizedEuropeanRepresentative:HansJ.Lehmann,Dipl.‐Ing
Wiesenstrasse14
Seelfingen
D‐78333Stockach,Germany
Tel+Fax+Modem+Voicemail
+49(7771)62386
OcuLight SL/SLx Operator Manual
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About the OcuLight SL and SLx
Introduction
TheIRISMedicalOcuLightSLandOcuLightSLx(SL/SLx)areadvancedlasersystems.
Thelasersource,powersupply,andcontrolpanelarecombinedinasingleunitmaking
itportableandeasytostackonacart,counterorothertreatmentroominstruments.

Thelaserconsoleusesmodernsemiconductordiodelasertechnologytoproducea
visibletreatmentbeamatanominalwavelengthof810nm.Diodelasersareefficient
andconsumeverylittleelectricalpower,thustheconsolemaybeoperatedfroma
standardpoweroutlet(115/230V)anddoesnotrequirewatercoolingortube
replacements.Thelaserconsoleusesasolid‐stateelectronicswitchingpowersupply
thatmeetsstrictU.S.andinternationalperformanceandsafetystandards.Thelaseris
controlledbyadedicatedmicroprocessorthatcontinuouslymonitorsthesafefunctionof
allsubsystems.

Thismanualcontainsimportantinformationonhowtounpack,setup,operate,
troubleshootandmaintainthissystem.Keepitavailableforreference.

Potential Adverse Effects
ImproperuseoftheSL/SLxcanresultinadverseeffects.Followtheinstructionsforuse
describedinthisoperatormanual.

CAUTION:Federal(U.S.)lawrestrictsthisdevicetosalebyorontheorderofaphysician.

CAUTION:Useofcontrolsoradjustmentsorperformanceofproceduresotherthanthose
specifiedhereinmayresultinhazardousradiationexposure.

CAUTION:Laserplumemaycontainviabletissueparticulates.
Indications for Use
TheSL/SLxisindicatedforretinalphotocoagulation,lasertrabeculoplasty,transscleral
cyclophotocoagulation,transscleralretinalphotocoagulationandiridotomy.



OcuLight SL/SLx Operator Manual
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
About the Components
Packing List
BeforeassemblingtheSL/SLx,makesurethepackagecontainsallorderedcomponents.
Checkthecomponentscarefullybeforeusetoensurenodamageoccurredduring
transit.

Allstandardshipmentsincludealaserconsole,footswitch,medicalgradepowercord,
keys,sparefusesremoteinterlockplug,laserwarningsign,thisoperatormanualand
anyotheraccessoriesthatyoumayhaveordered.



Ifthereareanyitemsmissingfromtheshipment,pleasecontactIRIDEXcustomer
serviceimmediately.
OcuLight SL/SLx Operator Manual
PN 13099D-EN
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Component Descriptions
Console
Theconsolecontainsthelaserhead,electronics,microprocessoranddisplaypanels.
Theconsoleisthesourceoflaseremissionandisthecentralunittowhichall
deliverydevicesattach.
Operator Manual
Theoperatormanualcontainsinstallation,operation,troubleshootingandsafety
instructions.Keepthemanualreadilyavailableforreference.
Footswitch
Thefootswitchactivatesthetreatmentbeamwhendepressed.
AC Power Cord
Thepowercordconnectstheconsoletoanelectricaloutlet.Theplugismedical
grade(hospitalgrade).Unpluggingthepowercordistheonlywaytoeliminatethe
flowofallelectricalcurrenttotheSL/SLx.
Key
Thekeyfitsintotheswitchonthefrontpanelandisusedtoturntheconsoleonand
off.
Spare Fuses
AClinefusesprotecttheSL/SLxfromover‐currentconditions.Twosparefusesare
provided.
OcuLight SL/SLx Operator Manual
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Positioning the SL/SLx
Temperature and Humidity Considerations
TheSL/SLxshouldbeoperatedinawell‐ventilatedlocationwithatemperaturebetween
10°C(50°F)and32°C(90°F)withrelativehumiditybetween20and80%,non‐
condensing.
Electrical Requirements
North American Installation
TheSL/SLxisequippedwithahospitalgrade(greendot)three‐wiregroundingplug.
Whenchoosingalocation,ensurethatagrounding‐typeACreceptacleisavailable,
asitisrequiredforsafeoperation.
Installation Outside of North America
WhentheSL/SLxisshipped,IRIDEXcustomersupportwillensurethatthepower
cordincludedinthepackagingisappropriateforlocaloperation.

ReplacementcordsmaybeorderedtomatchtheIEC320powerinletwithlocal
electricalstandards.Alwaysuseathree‐wiregroundingcordset.Donotalterthe
powerinlet,asitcontainsprotectivefusing.Followlocalelectricalcodesbefore
installingtheSL/SLxtoensurepropergrounding.
Physical Location Considerations
PlacetheSL/SLxonaflattable,existingoperatingroomequipmentorcart.
WARNING:Donotdefeatthepurposeofthegroundingpin.Thisequipmentisintendedtobe
electricallygrounded.Contactalicensedelectricianifthedesiredoutletpreventsinsertionofthe
groundingpin.
CAUTION:DonotpositionorusetheSL/SLxnearopenflames,compressedoxygenorother
flammables.

CAUTION:Allowenoughspacebetweentheconsoleandtheelectricaloutlettopermitaccessto
theplugatalltimes.
OcuLight SL/SLx Operator Manual
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Rear Panel Connections
Power
Cord
Footswitch Remote
Interlock
Plug
Required Connections
Power Cord
PlugthefemaleendofthepowercordintotheACPowerInlet.Inserttheopposite
endintoaproperlygroundedelectricaloutlet.
Footswitch
InsertthefootswitchconnectorintotheconnectorlabeledʺFootswitchʺ.Ensurethe
connectionissecure.
Remote Interlock
Inserttheremoteinterlockplugintotheremoteinterlockconnector.Ifdesired,this
circuitcanbeusedtodisabletheconsoleifthedoortothetreatmentroomisopened.
Tousetheremoteinterlock,attachthedoorswitchtothescrewterminalsinplaceof
theshortingwire.Iftheremoteinterlockisnotproperlyconnected,themessage,
“NoRemoteInterlock”willbedisplayedwhentheconsoleisturnedon.
Fuses
TheSL/SLxisshippedwithtwoindependentlinefusesinstalledbehindthepanel.
Thispanelshouldbeopenedonlyintheeventofablownfuse.Reviewthe
Maintenancesectionofthismanualforreplacementinstructions.

NOTE:IfyouhaveanOcuLightGLorOcuLightGLx,seeyouroperatormanualfor
instructionsonhowtocontrolbothlasersystemswithasinglefootswitch.
OcuLight SL/SLx Operator Manual
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Front Panel Controls and Connections
Feature Descriptions
Laser Status Display
Displaysspotsize,pulseduration,statusanderrormessages
Treat/Standby
TogglesthelaserstatusbetweenTreatandStandby.Thetreatmentlaserisenabled
onlywhenTreatisselected.
Mode
Multi‐functionbutton.Usedtodisplay,activate,confirmandclearmessagesand
settings.
Key Switch
Thekeyisusedtoturnthesystemonandoff.Storethekeybetweenusesina
securedlocationtopreventunauthorizeduse.
Emergency Stop
Disablesthelaserandelectroniccircuitsinanemergency.
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Power Knob
Rotateknobtoselectthedesiredlevelofenergytobedeliveredtothetissuethrough
theselecteddeliverydevice.Powerlevelisdisplayedinmilliwatts(mW).
Pulse Duration Knob
Rotateknobtoselectthedesiredpulseduration.Durationisdisplayedin
milliseconds(ms).
Pulse Interval Knob
Rotateknobtoselectthedesiredpulseinterval.Repeatintervalisdisplayedin
milliseconds(ms).
Counter Reset
Pressbuttontoclearthepulsecounter.
Fiber Port
Alldeliverydevicesareconnectedtotheconsoleatthefiberport.Covertheendof
theportwiththecapbetweenusestoprotectitfromdamage,dirtanddebris.
LIO Connector
InserttheilluminationfiberfromtheLIOtothisconnector.
SmartKey
Transmitselectricalsignalsfromselecteddeliverydevicestotheconsole.
Aiming Beam Brightness
Rotatetheknobclockwisetoincreaseaimingbeamintensity.
LIO Illumination
Rotatetheknobclockwisetoincreaseaimingbeamintensity.
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Operating Basics
Connecting a Delivery Device
Afterchoosingadeliverydevicefortreatment,insertthefiber‐opticintothefiberport.
Makesuretheconnectionissecure;however,donotover‐tightenthenut.IfaSlitLamp
Adapter(SLA)orOperatingMicroscopeAdapter(OMA)isused,connecttheSmartKey
fromthedeviceintothereceptacleonthefrontpaneloftheSL/SLx.Refertothe
deliverydeviceoperatormanualforadditionalinstructions.

NOTE:Alwayschecktheintegrityoftheattacheddeliverydevicebylookingforthepresenceof
theaimingbeam.IftheaimingbeamisnotpresentwhiletheSL/SLxissettoTreat,thismay
indicateaproblemwiththefiberoptic.Ifyouareindoubtastotheintegrityofthefiberoptic,
measurethetreatmentlaserwithapowermeter.

CAUTION:Donottwist,bendortightlycoilthedeliverydevicefiberoptic.Donotbendthe
fiberopticinloopssmallerthan6inchesindiameter.Looselydrapeorcoilexcesslengthonaflat
surface.Keepthefiber‐opticcableawayfromlocationswhereitmaybesteppedon.Donottouch
theendofthefiberopticasdirtorcontaminantsonthesesurfacesmayaffectoptical
transmission.AlwayscaptheendofthedeliverydevicewhennotattachedtotheSL/SLx.
Turning On the SL/SLx
Placethekeyintothekeyswitchand
turnclockwisetotheonposition.The
SL/SLxwillperformaself‐testand
warm‐upforseveralseconds.During
theself‐test,theSL/SLxchecksfor
propercomponentconnectionsand
anyinconsistencieswiththeinternal
safetysystem.Followingasuccessful
startupsequence,theyellowStandby
lightwillilluminateandthesystem
willentertheCW‐Pulseoperating
mode.Theattacheddeliverydevice
andspotsize,ifapplicable,arealso
displayed.
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Turning Off the SL/SLx
Afteruse,turnthekeytotheoffposition.Removeandstorethekeytoprevent
unauthorizeduse.Thekeycanonlyberemovedintheoffposition.Afterdisconnecting
adeliverydevice,insertandsecurethefiberportcaptothefiberport.
Emergency Stop
Intheeventofanemergency,pushtheredEmergencyStopbuttononthefrontpanel.
Thiswillimmediatelydisablethelaserandallrelatedelectroniccircuits.Thedisplay
willread“EmergencyStop!”.
Torecoverfollowinganemergencystop,turnthekeytotheoffposition.Aftera
minimumofthreeseconds,turnthekeybacktotheonposition.Afterrestarting,the
SL/SLxwillbeinStandbymodewiththepowersetto0mW.
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CW-Pulse Mode
Overview
CW‐PulseisthedefaultoperatingmodeontheSL/SLxandisactiveaftereachkeystart.
Inthismode,canbeprogrammedtodeliverasinglepulse,aseriesofregularlyspaced,
intermittentpulsesoracontinuouspulse.Thepulsedurationandintervalbetween
pulsescanbechangedoverarangeofmillisecond(10
‐3
)values(duration:10‐9000ms,
interval:50‐1000ms).TheCW‐Pulsewaveformisshownbelow:
Power
(mW)
Duration
(ms)
Interval
(ms)
Time
(ms)
Interval
(ms)
Duration
(ms)
Selecting Treatment Settings
Setting the Power
Atstartup,thedisplayedpowerissetto0mW.RotatethePowercontroltoselect
thedesiredvalue.Maximumpowervariesdependingontheattacheddelivery
device.



NOTE:Thepowercannotbeadjustedwhilethefootswitchisdepressed.

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Selecting the Pulse Duration
RotatetheDurationcontroltosetthetreatmentpulseduration.Thedisplaywill
showtheselecteddurationforeachtreatmentpulse.



Selecting the Repeat Interval

RotatetheRepeatIntervalcontroltoselectasinglepulseorrepeatingpulses.Toselect
asinglepulse,rotatetheknobcounterclockwiseuntilthedisplayisblank.Withthis
setting,theSL/SLxwilldeliverasingletimedpulseeverytimethefootswitchis
depressed.Toselectrepeatingpulses,rotatethecontrolclockwisetothedesiredvalue.
Thepulseswillrepeataslongasthefootswitchisdepressed.

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LongPulse Mode
Overview
InLongPulse,theSL/SLxgeneratesacontinuouswaveexposureforupto30minutes
whenalargespotdeliverydeviceisconnectedtothelaser(LargeSpotSLA,LargeSpot
LIOorOperatingMicroscopeAdapter).Thepowerisconstantthroughouttheduration
ofeachpulse.LongPulseisillustratedinthefollowingdiagram:
Power
(mW)
Duration
Up to 30 minutes
Using LongPulse Mode
Entering LongPulse Mode
ToaccesstheLongPulseoperatingmode,attachalargespotdeliverydevicetothe
SL/SLx.RotatetheDurationcontroluntilʺLPʺdisplaysintheDurationdisplay.



Selecting Parameters 
ContinuerotatingtheDurationcontrolclockwisetoselectthedesiredtreatment
time.Thetreatmentdurationperiodisshownisthetoprighthandportionofthe
statusdisplay.Thelowerrighthandportionofthestatusdisplayindicatesthe
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amountoftimethetreatmentbeamhasbeenactivatedduringthecurrenttreatment.
RotatethePowercontroltothedesiredlevel.

Initiating Treatment
Afterselectingalldesiredpulseparameters,pressTreat/StandbytoselectTreat.
Directtheaimingbeamontothetreatmentsite.Continuouslydepressthefootswitch
throughoutthetreatmentcycle.Theconsolewillemitanintermittentaudibletone
whenthetreatmentlaserisactivated.TheSL/SLxwillbeepmultipletimesupon
completionofthetreatmentexposure.Inthecounterdisplaytheshowstheamount
ofenergy,inJoules(J),deliveredduringthetreatment.PressCounterResettoclear
thedisplayandinitiateanothertimedtreatmentcycle.
NOTE:IfthefootswitchisreleasedpriortothecompletionofaprogrammedLongPulse
treatment,laseremissionwillstopimmediately.
NOTE:TherepeatintervaldisplaywillisblankwhentheSL/SLxisoperatedinLongPulse
mode.
Energy Display
InLongPulsemodetheCounterdisplayshowsthetotalenergy(Joules)deliveredto
thetissueduringthetreatmentsession.PressCounterResettoclearthisdisplay.
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MicroPulse Mode (OcuLight SLx Only)
Overview
MicroPulseisaspecialoperatingmodeavailableontheOcuLightSLx.InMicroPulse,
theSLxcanbeprogrammedtodeliverasinglepulseoraseriesofregularlyspaced,
intermittentpulses.InMicroPulsemodeeachpulseissubdividedintoshorter,regularly
spacedmicrosecondpulses.Consequentlytheamountofenergydeliveredtothetissue
ismuchlessthanwithequivalentlytimedpulsesinCW‐Pulsemode.MicroPulsemode
mayonlybeusedwithaslitlampadapter(SLA).TheMicroPulsewaveformis
illustratedinthefollowingdiagram:
Power
(mW)
Pulse Duration
(ms)
MicroPulse
Duration
(ms)
MicroPulse
Interval
(ms)
Pulse
Interval
(ms)
Pulse Duration
(ms)
Time
(ms)


Thepercentageoftimethetreatmentlaserisactivatedduringeachpulseisreferredtoas
thedutyfactor.Thedutyfactoriscalculatedaccordingtothefollowingformula:
100%
Interval
M
icroPulseDuration
M
icroPulse
Duration
M
icroPulse ×
+
=DutyFactor

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Using MicroPulse Mode
ToenterMicroPulsemode,pressandholdtheModebuttonforapproximatelytwo
secondsoruntilthestatusdisplayflashesʺMicroPulseʺ.PressModeagaintoactivate
theMicroPulsemenuoptions.Thedisplayshowsthefirstmenuoption.


Selecting a Preset Duty Factor
TherearethreepresetdutyfactorsettingsinMicroPulsemode:5%,10%and15%.
AfterenteringMicroPulsemodeanyofthesesettingscanbeselectedbypressingthe
Treat/Standbybuttontoscrollthroughtheselections.PressModetoselectand
confirmthedesiredselection.



NOTE:MicroPulsemodecanonlybeaccessediftheStatusDisplayreadsʺTri‐Mode
Activatedʺduringthestartupsequence.
NOTE:MicroPulsemodecannotbeusedwithaLargeSpotSlitLampAdapter.

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