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Page 1: Instructions for use - Brawn Medical · 2019. 8. 5. · Keeler PSL Classic Slit Lamp is an AC-powered Slit lamp biomicroscope is intended for use in eye examination of the anterior

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Instructionsforuse

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Page 2: Instructions for use - Brawn Medical · 2019. 8. 5. · Keeler PSL Classic Slit Lamp is an AC-powered Slit lamp biomicroscope is intended for use in eye examination of the anterior

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Contents1. Introduction

2. Symbols

3. Indicationsforuse

4. Intendeduse/purposeofinstrument

5. Briefdescriptionoftheinstrument

6. Safety

7. Cleaninganddisinfectioninstructions

8. Transport,storageandworkingconditions

9. Warningsandcautions

10.Namesofcontrolsandcomponents

11. Instructionsforuse

Preparing the power supply and the base unit

Preparing the Portable Slit Lamp prior to use

Preparing the patient

12. Problemsolving

13. Changingthebulb

14. Routineinstrumentmaintenance

15. Specificationsandelectricalratings

16. Technicalspecifications

17.Accessories

18. Contact,packaginganddisposalinformation

Please click on the contents to go straight to your chosen section or navigate by using the 'Next'

and 'Back' buttons to the right. Clicking on 'Home' will bring you back to this page.

As part of our policy for continued product development we reserve the right to amend specifications at any time without prior notice.

Page 3: Instructions for use - Brawn Medical · 2019. 8. 5. · Keeler PSL Classic Slit Lamp is an AC-powered Slit lamp biomicroscope is intended for use in eye examination of the anterior

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1. IntroductionThankyouforchoosingthisKeelerproduct.

PleasereadthismanualcarefullybeforeusingyourrechargeableKeeler

PortableSlitLamp,thiswillensurethesafetyofthepatientandensure

yougetthebestperformancefromthisprecisionopticaldevice.

Your Keeler Portable Slit Lamp includes:•PortableSlitLampilluminationbodyandmagnificationoptics

•Basechargerunit

•Powersupply–switchmodeallvoltages/frequencies(Part1941-P-7778)

•Userinstructionsandquickguide

•Lenscloth

Theinformationcontainedwithinthismanualmustnotbereproduced

inwholeorpartwithoutthemanufacturer'spriorwrittenapproval.The

manufacturerreservestherighttomakechangestospecificationsand

otherinformationcontainedinthisdocumentwithoutpriornotice.

Copyright©KeelerLimited2009.PublishedintheUK2009.

Please read and follow these instructions carefully.

PortableSlitLamp,thiswillensurethesafetyofthepatientandensure

•Powersupply–switchmodeallvoltages/frequencies(Part1941-P-7778)

Theinformationcontainedwithinthismanualmustnotbereproduced

inwholeorpartwithoutthemanufacturer'spriorwrittenapproval.The

manufacturerreservestherighttomakechangestospecificationsand

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2. Symbols ReaduserinstructionsforWarnings,Cautions

andadditionalinformation

Doubleinsulated

TypeBprotectionsagainstshock

Consultinstructionsforuse

Manufacturersnameandaddress

ThisSymbolontheProductoronitsPackaging

andinstructionsindicatesthatitwasputonthe

marketplaceafterAugust2005andthatthis

productshallnotbetreatedasHouseholdWaste.

Keepdry

Powerinputport

Fragile

Thiswayup

Materialsuitableforrecycling

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KeelerPSLClassicSlitLampisanAC-poweredSlitlamp

biomicroscopeisintendedforuseineyeexaminationofthe

anterioreyesegment,fromthecorneaepitheliumtothe

posteriorcapsule.Itisusedtoaidinthediagnosisofdiseasesor

traumawhichaffectsthestructuralpropertiesoftheanterior

eyesegment.

Thisdeviceisintendedtobeusedonlybysuitablytrainedand

authorisedhealthcareprofessionals.

3. Indications for use

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TheSlitLampisaninstrumentconsistingofalightsource

thatcanbefocusedtoshineathinsheet(slit)oflightintothe

eye.Itisusedinconjunctionwithabiomicroscope.Thelamp

facilitatesanexaminationoftheanteriorsegment,orfrontal

structuresandposteriorsegment,ofthehumaneye,which

includestheeyelid,sclera,conjunctiva,iris,naturalcrystalline

lens,andcornea.ThebinocularSlitLampexaminationprovides

stereoscopicmagnifiedviewoftheeyestructuresindetail,

enablinganatomicaldiagnosestobemadeforavarietyof

eyeconditions.

4. Intended use / purpose of instrument

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TheKeelerPortableSlitLampcomprisesarechargeablehand

heldportableilluminatedbiomicroscopesystemandadesk

mountedbasechargerunitthatispoweredfromalowvoltage

(12V)powersupply.

Thehandheldunitincorporatesalithiumionrechargeable

batterypoweringtheilluminationsystem.Theillumination

systemandfixationtargetsareactivatedusingadoubleclick

triggerlocatedonthefrontofthegrip/handle.Toincreaseor

reducethelightintensitythereisarheostatlocatedbelowthe

eyepiecesontherearofthegrip/handle.

The10xand16xmagnificationopticalsystemiscontrolledusing

aflipleverlocatedundertheadjustableeyepieces.

TheKeelerPortableSlitLampcomprisesarechargeablehand

heldportableilluminatedbiomicroscopesystemandadesk

mountedbasechargerunitthatispoweredfromalowvoltage

Thehandheldunitincorporatesalithiumionrechargeable

batterypoweringtheilluminationsystem.Theillumination

systemandfixationtargetsareactivatedusingadoubleclick

triggerlocatedonthefrontofthegrip/handle.Toincreaseor

reducethelightintensitythereisarheostatlocatedbelowthe

eyepiecesontherearofthegrip/handle.

The10xand16xmagnificationopticalsystemiscontrolledusing

aflipleverlocatedundertheadjustableeyepieces.

5. Brief description of the instrument

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6. SafetyTheKeelerPortableSlitLampisdesignedandbuiltinconformity

withECDirective93/42/EECandtheISO9000andEN46000

seriesqualitystandards.

The(EuropeanCommunity)markatteststhattheSlitLamp

complieswiththeprovisionsofAnnexesI,VI,andVIIofEC

Directive93/42/EEC.

Classification: CERegulation93/42EEC:ClassI

FDA:ClassII

Productionprocesses,testing,start-up,maintenance,andrepairs

areconductedinstrictconformitywiththeapplicablelawsand

internationalreferencestandards.

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6. SafetyWhenusingtheinstrument,scrupulouslyobservealltherelevant

accidentpreventionmeasuresestablishedbylawtoensurethe

safetyofthepatient.

Itiswellestablishedthatexposureoftheeyetointenselightsources

forextendedperiodsoftimeposesariskofretinalphoticinjury.

Manyophthalmicinstrumentsilluminatetheeyewithintenselight.

ThelightlevelsontheKeelerSlitLampiscontinuouslyadjustable

frommaximumtozero.Inadditionthereisaninfraredfilter

incorporatedintheilluminationsystemtoreduceIRlightlevels.

Novisibleretinallesionshavebeenidentifiedasaresultofusing

KeelerSlitLamps,howeveryoungchildrenandpersonswith

diseasedeyesmaybeatahigherrisk.Theriskmayalsobeslightly

increasedifthepersonbeingexaminedhashadanyexposure

withthesameinstrumentoranotherophthalmicinstrument

usinganintensevisiblelightsourceduringtheprevious24hours.

Thiswillapplyparticularlyiftheeyehasbeensubjectedto

retinalphotography.

Caution.Thelightemittedfromthisinstrumentis

potentiallyhazardous.Thelongerthedurationofexposure,the

greatertheriskofoculardamage.Exposuretolightfromthis

instrumentwhenoperatedatmaximumintensitywillexceedthe

safetyguidelineafter44minutes.

Figure 1: Relative spectral output of PSL Classic

Quantity MeasuredValue

Group 2 limit

Pass/FailGroup 2

Comments

Eir-cl 54.82mWcm-2 100mWcm-2 Pass -

LA-r 38.0mWsr-1cm-2 10Jcm-2 Pass withexposure

limit

Exposurelimit44minutes

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6. SafetyThefollowingstatementisprovidedforUScustomersandreferencesFDA

SlitLampGuidance.

Becauseprolongedintenselightexposurecandamagetheretina,the

useofthedeviceforocularexaminationshouldnotbeunnecessarily

prolonged,andthebrightnesssettingshouldnotexceedwhatisneeded

toprovideclearvisualizationofthetargetstructures.Thisdevice

shouldbeusedwithfiltersthateliminateUVradiation(<400nm)and,

wheneverpossible,filtersthateliminateshort-wavelengthbluelight

(<420nm).

Theretinalexposuredoseforaphotochemicalhazardisaproductofthe

radianceandtheexposuretime.Ifthevalueofradiancewerereducedin

half,twicethetimewouldbeneededtoreachthemaximum

exposurelimit.

Whilenoacuteopticalradiationhazardshavebeenidentifiedforslit

lamps,itisrecommendedthattheintensityoflightdirectedintothe

patient’seyebelimitedtotheminimumlevelwhichisnecessaryfor

diagnosis.Infants,aphakesandpersonswithdiseasedeyeswillbeat

greaterrisk.Theriskmayalsobeincreasedifthepersonbeingexamined

hashadanyexposurewiththesameinstrumentoranyotherophthalmic

instrumentusingavisiblelightsourceduringtheprevious24hours.This

willapplyparticularlyiftheeyehasbeenexposedtoretinalphotography.

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Onlymanualnon-immersioncleaningasdescribedshould

beusedforthisinstrument.Donotautoclaveorimmersein

cleaningfluids.Alwaysdisconnectpowersupplyfromsource

beforecleaning.

a Wipetheexternalsurfacewithacleanabsorbent,non-

sheddingclothdampenedwithawater/detergentsolution

(2%detergentbyvolume)orwater/isopropylalcohol

solution(70%IPAbyvolume).Avoidopticalsurfaces.

b Ensurethatexcesssolutiondoesnotentertheinstrument.

Usecautiontoensureclothisnotsaturatedwithsolution.

c Surfacesmustbecarefullyhand-driedusingacleannon-

sheddingcloth.

d Safelydisposeofusedcleaningmaterials.

7. Cleaning and disinfection instructions

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Thefollowingambientconditionlimitsarerecommended

fortheKeelerPortableSlitLamp,fortransportandstorage

itisrecommendedthattheSlitLampiskeptinitsoriginal

manufacturerspackaging.

BeforeusetheSlitLampshouldbeallowedtoadjusttothe

ambientroomtemperatureforseveralhours.

Thisisespeciallyimportantwhentheunithasbestored

ortransportedinacoldenvironment;thiscancausesevere

condensationontheopticalelements.

Working environment+10°Cto+35°C

30%to75%relativehumidity

Transport and storage conditionsTransport:-40°Cto+70°C

Storage:-10°Cto+55°C

8. Transport, storage and working conditions

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Observe the following prescriptions in order to ensure safe operation of the instrument

Warning

• Neverusetheinstrumentifvisiblydamagedandperiodically

inspectitforsignsofdamageormisuse.

• Neverusetheinstrumentiftheambienttemperature,

atmosphericpressure,and/orrelativehumidityareoutsidethe

limitsgivenabove.

• Beforeanycleaningoftheinstrumentorthebaseunitensure

thepowerleadisdisconnected.

• Cleanonlytheexteriorsurfacesoftheinstrumentfollowing

theinstructionscontainedinthismanual.

• Thisproductshouldnotbeimmersedinfluid.

• Repairsandmodificationstotheinstrumentmustbemade

onlybythespecializedtechniciansofthemanufacturer’s

TechnicalServiceCentreorbypersonneltrainedand

authorisedbythemanufacturer.Themanufacturerdeclines

anyandallresponsibilityforlossand/ordamagesresulting

fromunauthorisedrepairs;furthermore,anysuchactionswill

invalidatethewarranty.

• Shouldtheinstrumentsuffershocks(forexample,should

itaccidentallyfall),andtheopticalsystemortheillumination

systemaredamageditmaybenecessarytoreturnthe

instrumenttothemanufacturerforrepair.

• Alwayscarefullyobservethesafetyrulesandother

precautionspublishedherein.

• Thisdeviceisintendedtobeusedonlybysuitablytrainedand

authorisedhealthcareprofessionals.

• FederalLawrestrictsthisdevicetosalebyorontheorderofa

physicianorpractitioner.

• Theowneroftheinstrumentisresponsiblefortraining

personnelinitscorrectuse.

• Routepowercordssafelytoeliminateriskoftrippingor

damagetouser.

• Ensuretheinstrumentisplacedonalevelandstablesurface.

• Donotuseinthepresenceofflammablegas/liquid.

• ThebulbmaybehotiftheSlitLamphasbeenincontinuous

use,takecarewhenremovingthebulb.

• Afterremovalofthebulb,donottouchbulbcontactsand

patientsimultaneously.

• OnlyuseapprovedKeelerpowersupply

1941-P-7778orinstrumentmay

malfunction.

9. Warnings and cautions

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12

3

45

67

8

9

Portable Slit Lamp illumination body andmagnification optics1. Trigger Click and hold the trigger to turn the lamp illumination on. Double click (similarly to a computer mouse button) to turn both the illumination lamp and fixation targets on.

2. Prism optical body Projects a thin sheet (slit) of light perpendicular to the prism face.

3. Eyepieces – dioptrical adjustment Rotate clockwise to achieve a + (plus) setting and anti-clockwise for a – (minus) setting.

4. Eyepieces – PD adjustment Rotate the left eyepiece anti-clockwise and the right eyepiece clockwise to increase the PD value. Rotate the left eyepiece clockwise and the right eyepiece anti-clockwise to decrease the PD value.

5. Latex free protective sleeves These sleeves can be folded forwards to better suit spectacle wearers.

6. Fixation targets Provides a light source for the patient to focus upon. Double click (similarly to a computer mouse button) to turn both the illumination lamp and fixation targets on.

7. Objective lenses These lenses are flush with the external surface at a magnification of 10x and protrude from the device at a magnification of 16x.

8. Slit wheel Rotate the slit wheel to select either a slit of 0.15mm (0.15), 0.5mm (0.5), 0.8mm (0.8), 1.6mm (1.6), a circle of 12mm (O), or a square of 1mm ( ) for a/c flare assessment. (The text in the brackets corresponds to the icons on the slit wheel.)

9. Filter wheel Rotate the filter wheel to select either a red free (R.F), blue (B.F), neutral density (N.D) or clear filter (O). (The text in the brackets corresponds to the icons on the filter wheel.)

10. Names of controls and components

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Portable Slit Lamp illumination body and magnification optics10. Magnification change lever Push this lever to the right to set the magnification at 10x and to the left to set the magnification at 16x.

11. Alternative power socket In addition to charging through the base charger unit, the device can also be charged through this socket.

12. Charging LED The yellow charging LED is on continuously during normal charging and blinks when trickle charging. Trickle charging can occur at the start of charging a completely discharged battery or when attempting to charge a completely charged battery.

13. Battery state LED The yellow battery state LED blinks when the battery is almost empty.

14. Brightness adjustment wheel Rotating this wheel clockwise increases the brightness of the illumination lamp. Rotating this wheel anti-clockwise decreases the brightness of the illumination lamp.

Portable Slit Lamp base charger unit15. Power socket for Keeler 12V Power Supply Connect the power supply cable to this socket and the place the slit lamp body in the charger unit to charge the device.

16. Recharging connection pins Connects the slit lamp body to the charger unit to charge the device.

17. Recess for slit lamp body Place the slit lamp body in the charger unit when not in use.

18. Grooves for power cable Place the power supply cable in the most suitable groove to keep the unit tidy.

19. Protective rubber feet Ensures the surface onto which the charger unit is placed does not become scratched.

20. Charging safety feature Note: No electrical power is conducted through the pins (16) until the slit lamp body is placed into the recess of the charger unit.

10. Names of controls and components

Home

Portable Slit Lamp illumination body and magnification optics

Push this lever to the right to set the magnification at 10x and to the left to set the magnification at 16x.

In addition to charging through the base charger unit, the device can also be charged through this socket.

The yellow charging LED is on continuously during normal charging and blinks when trickle charging. Trickle charging can occur at the start of charging a completely discharged battery or when attempting

Rotating this wheel clockwise increases the brightness of the illumination lamp. Rotating

10. Names of controls and components

10

14

13

11 1216

17

19

18

15

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11. Instructions for use

Preparing the power supply and the base unit1.Attachtheappropriatemainsplugadaptertothetransformer

afterremovingtheblankingplateorifrequireduseanIEC

60320type7connector(notsupplied).

2.Connecttheoutputpowersupplycabletothesocketonthe

undersideoftherechargingbaseunit.

3.PlacethePortableSlitLamponthebasechargerunit,

theyellowLEDwillilluminatetoindicatetheunitisbeing

charged.Fromfullydischargedtofullychargedusuallytakes

2.5hours.

Illumination ‘on time’ 50minutes

(whenusedatfullintensityfromfullycharged)

IEC 60320 TYPE 7 connector

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11. Instructions for use

Preparing the Portable Slit Lamp prior to use1. SetthePupillarydistanceoftheeyepiecesbyfirmlygrasping

themandadjustingthedistancebygentlyrotatingtheprism

bodiesinwardsoroutwardsuntilafullcircularimageisseen

binocularly.

2.Adjustthedioptricpowerofeachof

theeyepieces,oneatatime.Adjust

theeyepiecetoit’shighest+(plus)

settingandlookingthroughthe

opticsattheperipheralfocusmarker,

slowlyadjusttheeyepiecetowards

the–(minus)settinguntilthefocus

markerissharplyinfocus.Repeat

thisfortheothereyepiece.

Note – Spectacle wearers may prefer to fold the rubber eye cup

forwards.

3.Setthemagnificationtoeitherx10orx16usingthe

magnificationchangelever.

4.Selectyourpreferredslitwidthandfilterbyrotatingtheslit

andthefilterwheels.

5.Tosettheslitatananglerotatetheilluminationtowerabout

itspivotaxis.

6.Holdingtheslitlampfirmlyclickandholdthetriggertoturn

ontheilluminationlamp.Doubleclickandholdthetriggerto

turnonboththeilluminationlampandfixationtargets.The

lampdoesnotruncontinuously,afteradurationof2minutes

itautomaticallyswitchesoff.

Note – for very small or young patients,

babies in arms and some animals,

sometimes it may be preferable to use

the Portable Slit Lamp inverted –

see illustration.

Note – it can be beneficial to

stabilize the Slit Lamp using the

technique shown in the

illustration below.

Peripheralfocus marker

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11. Instructions for usePreparing the patientThepatientshouldbeascomfortableaspossibleandpositioned

toalloweasyaccesstotheeyetobeexamined.

TheKeelerportableSlitLampisdesignedtobeambidextrous,

holdtheSlitLampinyourpreferredhandsimultaneously

squeezingthetriggeron/offswitch.

Toimprovestability,especiallyathighermagnificationsyoumay

liketouseyourotherhandasa‘bridge’betweentheSlitLamp

bodyandthepatient.

AswithotherSlitLampexaminationproceduresitmaybe

necessarytoelevatethepatient’slid.

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12. Problem solving

Problem Solution

Noillumination,

orlow

illumination

Checktheunitisfullycharged

Checkthepositionofthefiltersand

slitstoensuretheyaresetcorrectly

Checkandifnecessarychange

thebulb

Slitslantedatan

angle

Checkthepositionoftheslitdisc,it

maynotbelocatedcorrectlyataslit

position

Circleincomplete

oroffset

Checkthepositionoftheslitand

filterdiscs,itmaynotbelocated

correctlyataslitposition

PoorfocusCheckthedioptricsettingsofthe

eyepieces

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13. Changing the bulb WarningthebulbmaybehotiftheSlitLamphasbeen

incontinuoususe,takecarewhenremovingthebulb.

Thebulbhasalonglifeexpectancyofapproximately2,000hours.

Makesurethepowerisdisconnectedbeforechangingthebulb.

Tochangethebulb,firstallow5minutesforittocooldownif

theSlitLamphasbeeninuse.

This is how you change a bulb1. Unscrewtheblackplasticbulbcoverbyturning

anti-clockwise.

2.Removetheoldbulb,allow5minutesforittocool

downiftheSlitLamphasbeeninuse.

3.Insertthenewbulb,ensuringthe

notchisfacingupwardsasshown.

1

2

3

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Regularlyinspectthedevicefordamageordirt.

Caremustbetakentokeeptheobjectiveandtheeyepiecelenses

clean–useonlysoftcleanlensclothstocleanopticalsurfaces.

Routinelycleanaspersection7.Cleaninginstructions.

Themanufacturerdeclinesanyandallresponsibilityand

warrantycoverageshouldtheinstrumentbetamperedwith

inanymannerorshouldroutinemaintenancebeomitted

orperformedinmannersnotinaccordancewiththese

manufacturer’sinstructions.

Caution

KeelerSlitLampsshouldbecleanedandservicedregularly.

AnyservicingorrepairsshouldonlybecarriedoutbyKeelerLtd.

orbysuitablytrainedandauthoriseddistributors.

Therearenouserserviceablepartsinthisinstrument.Service

manualswillbeavailabletoauthorisedKeelerservicecentresand

Keelertrainedservicepersonnel.

14. Routine instrument maintenance

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15. Specifications and electrical ratings

Guidance and manufacturer’s declaration – electromagnetic immunity

TheKeelerPortableSlitLampisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerorusershouldassurethatitisusedinsuchanenvironment.

Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance

Electrostaticdischarge(ESD).IEC6100-4-2

±6kVcontact

±8kVair

±6kVcontact

±8kVair

Floorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.

Electricalfasttransient/burst.IEC61000-4-4

±2kVforpowersupplylines±1kVforpowersupplylines

±2kVforpowersupplylines±1kVforinput/outputlines

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

Surge.IEC61000-4-5

±1kVline(s)toline(s)±1kVline(s)forinput/outputline(s)

±1kVline(s)toline(s)±1kVline(s)forinput/outputline(s)

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

Voltagedips,shortinterruptionsandvoltagevariationsonpowersupplyinputlines.IEC61000-4-11

<5%UT(>95%dipinUT)

40%UT

(60%dipinUT)for5cycles

70%UT(30%dipinUT)for25cycles

<5%UT

(>95%dipinUT)for5s

<5%UT(>95%dipinUT)

40%UT

(60%dipinUT)for5cycles

70%UT

(30%dipinUT)for25cycles

<5%UT

(>95%dipinUT)for5s

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.IftheuseroftheKeelerPortableSlitLamprequirescontinuedoperationduringpowermainsinterruptions,itisrecommendedthattheinstrumentbepoweredfromanuninterruptiblepowersupply.

Powerfrequency(50/60Hz)magneticfield.IEC61000-4-8

3A/m 3A/m Powerfrequencymagneticfieldsshouldbeatalevelcharacteristicofatypicallocationinatypicalcommercialorhospitalenvironment.

NoteUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.

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TheKeelerPortableSlitLampisamedicalelectricalinstrument.Theinstrumentrequiresspecialcareconcerning

electromagneticcompatibility(EMC).ThisSectiondescribesitssuitabilityintermsofelectromagneticcompatibilityof

thisinstrument.Wheninstallingorusingthisinstrument,pleasereadcarefullyandobservewhatisdescribedhere.

1.Portableormobile-typeradiofrequencycommunicationunitsmayhaveanadverseeffectonthis

instrument,resultinginmalfunctioning.

15. Specifications and electrical ratings

Guidance and manufacturer’s declaration – electromagnetic emissions

TheKeelerPortableSlitLampisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerorusershouldassurethatitisusedinsuchanenvironment.

Emissions test Compliance Electromagnetic environment - guidance

RFemissionsCISPR11

Group1 TheKeelerPortableSlitLampusesRFenergyonlyforitsinternalfunction.Therefore,itsRFemissionsareverylowandarenotlikelytocauseanyinterferenceinnearbyelectronicequipment.

RFemissionsCISPR11

ClassA TheKeelerPortableSlitLampissuitableforuseinallestablishmentsotherthandomesticandthosedirectlyconnectedtothepubliclow-voltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.

HarmonicemissionsIEC61000-3-2

ClassA

Voltagefluctuations/flickeremissionsIEC61000-3-3

Complies

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15. Specifications and electrical ratings

Guidance and manufacturer’s declaration – electromagnetic immunity

TheKeelerPortableSlitLampisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerorusershouldassurethatitisusedinsuchanenvironment.

Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance

ConductedRFIEC61000-4-6

RadiatedRFIEC61000-4-3

3Vrms

3V/m

80MHzto2.5GHz

3V

3V/m

PortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartoftheKeelerPortableSlitLamp,includingcables,thantherecommendedseparationdistancescalculatedfromtheequationapplicabletothefrequencyofthetransmitter.

Recommended separation distanced=1.2√p

d=1.2√p80MHzto800MHz

d=2.3√p800MHzto2.5GHz

Wherepisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufactureranddistherecommendedseparationdistanceinmetres(m).

FieldstrengthsfromfixedRFtransmitters,asdeterminedbyanelectromagneticsitesurvey¹,shouldbelessthanthecompliancelevelineachfrequencyrange.²

Interferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:

Note 1 At80MHzand800MHz,thehigherfrequencyrangeapplies.Note 2 Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures, objectsandpeople.¹ Fieldstrengthsfromfixedtransmitters,suchasbasestations(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMand FMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRF transmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheKeelerPortableSlit LampisusedexceedstheapplicableRFcompliancelevelabove,theKeelerPortableSlitLampshouldbeobservedtoverifynormaloperation.If abnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasre-orientatingorrelocatingtheKeelerPortableSlitLamp.² Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

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15. Specifications and electrical ratings

Recommended separation distances between portable and mobile RF communications equipment and the Keeler Portable Slit Lamp

TheKeelerPortableSlitLampisintendedfortheuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomerortheuseroftheKeelerPortableSlitLampcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andtheKeelerPortableSlitLampasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.

Rated maximum output power of

transmitterW

Separation distance according to frequency of transmitterm

50kHzto80MHz

d=1.2√p

80MHzto800MHz

d=1.2√p

800MHzto2.5GHz

d=2.3√p

0.01 0.12 0.12 0.23

0.01 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmetres(m)canbedeterminedusingtheequationapplicabletothefrequencyofthetransmitter,wherepisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.

Note 1 At80MHzand800MHz,theseparationdistanceforthehigherfrequencyapplies.Note 2 Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objects andpeople.

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16. Technical specifications

BiomicroscopeType BinocularHandheldBiomicroscopeSlitLamp

Optics Convergingbinocularsat13˚

Magnification 10xand16x,leverchange

Objective lens working distance @ 10x 100mm

Objective lens working distance @ 16x 80mm

Field of view @ 10x 16mm

Field of view @ 16x 10.5mm

PD range 50mmto72mm

Eyepiece dioptric adjustment range +/-7Dioptres

Size: Hand held device 238x116x210mm

Docking station 205x138x40mm

Weight: Hand held device ~900g

Docking station 300g

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16. Technical specifications

Slit and filter systemSlit type RotatingSlitwheelselectionSlitLamp

Slit length 12mm

Slit widths 0.15mm,0.5mm,0.8mmand1.6mmslits,12mmcircleanda1mmsquare

Filters Redfree,Blue,Neutraldensity0.8andClear

IR protection InbuiltIRcutfilter

Slit angle +/-60˚

Illumination control Continuouslyvariablefromlowtofullbrightness

Power supplyPower supply unit Switchmode,(110V–240V)+/-10%multiplugcompliantto EN60601-1EN61000-6-2,EN61000-6-3

Power supply output 30VA(12VDC2.5A)

Complies with ElectricalSafety(Medical)BSEN60601-1:2006 ElectromagneticcompatibilityEN60601-1-2:2007 Ophthalmicinstruments-Fundamentalrequirementsandtestmethods ISO15004-1:2006 Ophthalmicinstruments-OpticalradiationhazardISO15004-2:2007

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17. AccessoriesAccessories Aluminium Carry Case Part Number 3010-P-7000

Test Bar Part Number EP39-70737

Power Supply Part Number 1941-P-7778

2x Rubber Eye Caps Part Number 3010-P-7004

ConsumablesSlit Lamp 6V 15W Bulb Part Number 1030-P-7187

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18. Contact, packaging and disposal Information

ManufacturerKeeler Limited Clewer Hill RoadWindsorBerkshireSL4 4AA

Freephone: 0800 521251Tel: +44 (0) 1753 857177Fax: +44 (0) 1753 827145

USA Sales OfficeKeeler USA456 ParkwayBroomallPA 19008USA

Toll Free: 1 800 523 5620Tel: 1 610 353 4350Fax: 1 610 353 7814

3010-P-7001IssueG

Disposal of old Electrical and Electronic Equipment (ApplicableintheEuropeanUnionandotherEuropeanCountrieswith

separateCollectionSystems).

ThisSymbolontheProductoronitsPackagingandinstructions

indicatesthatitwasputonthemarketplaceafterAugust2005and

thatthisproductshallnotbetreatedasHouseholdWaste.

ToReducetheEnvironmentalimpactofWEEE(WasteElectricalElectronic

Equipment)andminimisethevolumeofWEEEenteringlandfillswe

encourageatProductendoflifethatthisEquipmentisrecycledandreused.

If you need more information on the collection reuse and recycling then

please contact B2B Compliance on 01691 676124 (+44 1691 676124).