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All Pupil II Ophthlmoscopes/All Pupiil 2...May 21, 2007  · Home Back Next 10 5. Setting up and using the All Pupil II Headband Adjustment Comfortable Fit Adjust the Height and Size

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Page 1: All Pupil II Ophthlmoscopes/All Pupiil 2...May 21, 2007  · Home Back Next 10 5. Setting up and using the All Pupil II Headband Adjustment Comfortable Fit Adjust the Height and Size

NextNext

All Pupil IIIndirect Ophthalmoscope

Instructionsforuse

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Contents Page

1. Copyrightandtrademarks................................................... 3

2. Introduction........................................................................... 4

3. Symbols.................................................................................. 5

4. Safety..................................................................................... 6

• Deviceclassification

• Warnings

• Cautions........................................................................... 7

• Safetyconsiderations...................................................... 8

5. SettingupandusingtheAllPupilII.................................... 9

• Productdescription

• Controlsandcomponents

• Headbandadjustment.................................................. 10

• Ophthalmoscopealignment

• Interpupillarydistancesettingcontrol........................ 11

• Obtainingafusedimage

• Mirroranglecontrol

• Headdimmerswitch

• Settingtheaperture..................................................... 12

• Selectingfilters.............................................................. 13

6. Wirelesschargers................................................................ 14

• Powersupply

• Standardlithium........................................................... 15

Page

• Slimlinelithiumion....................................................... 16

• Chargingandchargingcycle........................................ 17

• Wallmounting.............................................................. 20

7. SmartPackandWallPack..................................................... 22

• Partslist

• Powerconversion.......................................................... 23

• Wallmounting/charging............................................ 24

• LEDdisplays................................................................... 25

8. LED/bulbreplacement......................................................... 26

9. Cleaninginstructions.......................................................... 27

10. Specificationsandelectricalratings.................................. 28

• Electricalspecifications

• Transport,storageandoperation

11.AnnexI–EMCstatementandguidelines......................... 29

12. Sparepartsandaccessories................................................ 34

• APIIILED....................................................................... 35

• Teachingmirror............................................................. 36

• EyepieceCaps................................................................ 37

• PlanoLenses

• ExpressiOnCliponCovers

13.Warranty.............................................................................. 38

14.Contactanddisposalinformation..................................... 39

Click on the headings above to go directly to that section.

Usethebuttonsontherighttonavigatethedocument.

Clicking‘Home’fromanypagebringsyoubacktothiscontentspage.

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1. Copyright and trademarks

Theinformationcontainedwithinthismanualmustnotbereproducedin

wholeorinpartwithoutthemanufacturer’spriorwrittenapproval.

Aspartofourpolicyforcontinuedproductdevelopmentwereservethe

righttomakechangestospecificationsandotherinformationcontained

inthisdocumentwithoutpriornotice.

AllPupilIIandAllPupilIILEDareregisteredtrademarksof

KeelerLtd2012.

Copyright©KeelerLimited2012.

PublishedintheUK2012.

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2. Introduction

ThankyouforpurchasingtheKeelerAllPupilIIIndirectOphthalmoscope.

Wehavetakenthegreatestcareinthedesign,developmentand

manufactureofthisproducttoensurethatyougetmanyyearsof

troublefreeservice.However,itisimportantthatyoureadthe

descriptions,installationandoperatinginstructionscarefullypriorto

installingorusingyournewindirectophthalmoscope.

Please read and follow these instructions carefully.

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3. Symbols

Readuserinstructionsforwarnings,cautionsand

additionalinformation

TheCEmarkonthisproductindicatesithasbeen

testedtoandconformswiththeprovisionsnoted

withinthe93/42/EECMedicalDeviceDirective

Consultinstructionsforuse

Doubleinsulated

Manufacturer'snameandaddress

ThisSymbolontheproductoronitspackaging

andinstructionsindicatesthatitwasputonthe

marketplaceafterAugust2005andthatthis

productshallnotbetreatedasHouseholdWaste

TypeBprotectionsagainstshock

Mandatoryactionsign

Followinstructionsforuse

Highvoltage

Triphazard

Opticalradiationhazard

Hotsurface

Non-ionizingradiation

Thiswayup

Keepdry

Fragile

Materialsuitable

forrecycling

Keepdry

Materialsuitable

forrecycling

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4. Safety

Device classificationCERegulation93/42EEC:ClassI

FDA:ClassII

CarefullyreadthisInstructionSectionbeforeusingyourKeeler

product.Foryourownsafetyandthatofyourcustomers

observeallcautionaryinformationprovidedinthissection.The

followinginformationisintendedtohighlightpotentialsafety

hazardsthatcanbeassociatedwithmisuse,ordamage.

Warnings and cautions

Warning

• CheckyourKeelerproductforsignsoftransport/storage

damagepriortouse

• Donotuseiftheproductisvisiblydamaged,andperiodically

inspectforsignsofdamage

• Donotuseinthepresenceofflammablegases/liquids,orin

anoxygenrichenvironment

• Thisproductshouldnotbeimmersedinfluids

• Donotdisassembleormodifythebattery.Thereareno

serviceablepartsinside

• Donotdisposeofbatteryinfire,punctureorshortcircuit

• Donotuseabatterythatisdeformed,leaking,corrodedor

visuallydamaged.Handleadamagedorleakingbatterywith

care.Ifyoucomeintocontactwithelectrolyte,washexposed

areawithsoapandwater.Ifitcontactstheeye,seekmedical

attentionimmediately

• USFederallawrestrictsthisdevicetosalebyororderofa

physicianorpractitioner

Donotfitmainspoweradapterintoadamagedmains

outletsocket

Routepowercordssafelytoeliminateriskoftrippingor

damagetoequipment

Bulbs/LED’scanreachhightemperaturesinuse–allow

tocoolbeforehandling

Donotexceedmaximumrecommendedexposuretime

Afterremovalofthebulb/LEDdonottouchthebulb/

LEDcontactsandthepatient

simultaneously

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4. Safety

Caution

• UseonlygenuineKeelerapprovedpartsandaccessoriesor

devicesafetyandperformancemaybecompromised

• UseonlyKeelerapprovedbatteries,chargersandpower

suppliesaspertheaccessorieslistedinsection12

• Theproducthasbeendesignedtofunctionsafelywhenatan

ambienttemperaturebetween+10°Cand+35°C

• Keepoutofthereachofchildren

• Topreventcondensationfromforming,allowinstrumentto

cometoroomtemperaturebeforeuse

• Forindooruseonly(protectfrommoisture)

• Whenreplacinglithiumbatterypack,turnindirectoffand

attachnewpack

• Removebatterieswhendevicemaynotbeusedforprolonged

periods

• Donotchargebatteryinanyenvironmentwherethe

temperaturemayexceed40˚Corfallbelow0˚C

• Therearenouserserviceablepartsinside.Contactauthorised

servicerepresentativeforfurtherinformation

• Ensurebatteryorientationiscorrect,orpersonalinjury/

damagetoequipmentmayoccur

• Careshouldbetakenwhenhandlinghalogenbulbs.Halogen

bulbscanshatterifscratchedordamaged

• Ensuredeviceissecurelyheldindockingstationtominimise

riskofinjuryordamagetoequipment

• Followguidanceoncleaning/routinemaintenancetoprevent

personalinjury/damagetoequipment

Switchofftheelectricalsupplyanddisconnectfrom

themainselectricalsupplybeforecleaningandinspection

• Disposeofbatteriesinlinewithlocalenvironmental

regulations

• Atproductendoflifedisposeofinaccordancewithlocal

environmentalguidelines(WEEE)

Note:LithiumIonbatteriescontainnotoxicheavymetals

suchasmercury,cadmiumorlead

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4. Safety

Safety considerationsItiswellestablishedthatexposureoftheeyetointenselight

sourcesforextendedperiodsoftimeposesariskofretinal

photicinjury.Manyophthalmicinstrumentsilluminatetheeye

withintenselight.Thedecisionabouttheintensityofthelight

leveltouseinanyproceduremustbemadeonacasetocase

basis.Ineachcase,theclinicianmusttakeariskbenefit

judgementabouttheintensityoflighttobeused.Useof

insufficientintensitymayresultininadequatevisualizationand

inadverseeffectsmoreseriousthanretinalphoticdamage.

Further,despitealleffortstakentominimisetheriskofretinal

damage,damagemaystilloccur.Retinalphoticinjuryisa

possiblecomplicationoftheneedtousebrightlightclearly

visualizeocularstructureduringdelicateophthalmicsurgical

procedure.

Whilenovisibleretinallesionshavebeenidentifiedfor

ophthalmicinstruments,itisrecommendedthatillumination

levelsbesettotheminimumlevelnecessarytoperformthe

diagnosticfunction.Youngchildrenandpersonswithdiseased

eyesmaybeatahigherrisk.Theriskmayalsobeincreasedif

thepersonbeingexaminedhashadanyexposurewiththesame

instrumentoranyotherophthalmicinstrumentusinganintense

visiblelightsourceduringtheprevious24hours.Thiswillapply

particularlyiftheeyehasbeenexposedtoretinalphotography.

Thelightemittedfromthisinstrumentispotentiallyhazardous.

Thelongerthedurationofexposure,thegreatertheriskof

oculardamage.Exposuretolightfromthisinstrumentwhen

operatedatmaximumintensitywillexceedthesafetyguideline

after17minutes.ThelimitfortheAPIIILEDis35minutes.

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5. Setting up and using the All Pupil II

Description of the ProductA HeadbandSizeAdjuster

B HeadbandHeightAdjuster

C CushionedPaddedLiners

D ApertureControlLever

E HeadbandDimmerSwitch

F BrowBarAdjuster

G FrontWindow

H BinocularBlock

A

B

D

E

F

F

G

H

J

K

K

L

M

C

C

IBrowBar

J InterpupillaryDistanceSettingControl

K MirrorAngleControl

L OpticsHingeAdjuster

MFilterSelectorBar

I

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5. Setting up and using the All Pupil II

Headband AdjustmentComfortableFit

AdjusttheHeightandSizeAdjusters(AandB)

sothattheindirectissupportedcomfortably,as

showninfigs1and2.

OphthalmoscopeAngleAlignment

PositiontheBrowBar(I)suchthatthe

BinocularBlock(H)issetontheopticalaxis.

TheBrowBar(I)maybecorrectlypositioned

bylooseningtheBrowBarAdjusters(F).When

inthecorrectpositionsecurebytightening(F)

asshowninfig3.

PositiontheAllPupilIIasclosetotheeyesas

possibleformaximumfieldasshowninfig4.

byusingtheOpticsHingeAdjuster(L).

fig.1

fig.3

fig.2

fig.4

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5. Setting up and using the All Pupil II

Interpupillary Distance Setting Control (J)Becausetheeyesaredissociated,particularcaremustbetaken

toensuretheoptics(eyepieces)aresetproperlyinfrontofeach

eye.

AlwayssettheApertureControlLever(D)tothelargelight

patchforthisexercise.

Placeanobject,perhapsthethumb,approximately40cmfrom

thefaceandcentreithorizontallyinthelightpatch.Then,close

oneeye.Usingthethumbandforefingeroftheoppositehand,

slidetheInterpupillaryDistanceSettingControl(J)oftheopen

eye(locateddirectlyundereacheyepiece)sothatyourobject

movesintothecentreofthefield,keepingtheobjectinthe

centreofthelightpatch.Repeatfortheothereye.

Obtaining a Fused ImageEnsurethatasingular,fusedimageisobtainedasfollows:

Mirror Angle Control (K)Thelightispositionedverticallyintotheuppertwothirdsofthe

fieldofviewbyrotatingthespindle(K)locatedoneithersideof

thebinocularblock.

Head Dimmer Switch (E)Turntheilluminationonbyrotatingtheheadbanddimmer

switch(E)inananticlockwisedirection.

SeparateimagesFusedimageOverlappingimages

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5. Setting up and using the All Pupil II

Aperture Control Lever (D)TheApertureControlLever(D)changestheaperturesizeto

viewthroughlarge,mediumandsmallpupils.

Selecteitherthelarge,intermediateorsmallapertureby

adjustingleverfromlefttoright-small-intermediate-large.

Large

Thelarge,roundhomogenouspatchissuitableforroutine

examinationsthroughfullydilatedpupils

Intermediate

Theintermediatepatchisdesignedtoreducereflections

whenenteringapartiallyorpoorlydilatedpupil(3mm).It

isalsoidealforcloserinspectionofparticularfundalareas.

Small

Thislightpatchisidealforsmall,undilatedpupils.

Selecteitherthelarge,intermediateorsmallaperturebyTheintermediatepatchisdesignedtoreducereflections

whenenteringapartiallyorpoorlydilatedpupil(3mm).It

isalsoidealforcloserinspectionofparticularfundalareas.

Small

Thislightpatchisidealforsmall,undilatedpupils.

adjustingleverfromlefttoright-small-intermediate-large.

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5. Setting up and using the All Pupil II

Filter Selector Bar (M)TheAllPupilIIhastwoselectablefiltersbuiltintothe

headunit.SelecttheappropriatefilterbyslidingtheFilter

SelectorBar(M)eitherleftorrightfromitsmidposition.

TheFilterSelectorBarismarkedwithdotstoindicatein

whichdirectiontoslideitforeachfilter.

RedFreeFilter

Thisfilterreducesredlight,sobloodwillappearblack,

silhouettedagainstadarkbackground.

Diffuser

Thisuniqueextrawidebeamofdiffusedlightpermitsa

morerelaxedtechniqueduringmorechallengingfundus

examinations.Beginnersmayalsofindthisaperture

particularlyhelpfulsince,inordertoachieveafulllens

image,thealignmentbetweentheheadset,the

condensinglensandthepupilisnotascriticalaswiththe

conventionalbeam.

TheinstrumentprovidesprotectionfromUV/IR.

whichdirectiontoslideitforeachfilter.morerelaxedtechniqueduringmorechallengingfundus

examinations.Beginnersmayalsofindthisaperture

particularlyhelpfulsince,inordertoachieveafulllens

image,thealignmentbetweentheheadset,the

condensinglensandthepupilisnotascriticalaswiththe

conventionalbeam.

TheinstrumentprovidesprotectionfromUV/IR.

whichdirectiontoslideitforeachfilter.

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IEC60320TYPE7connector

6. Wireless chargers – power supply assembly

Set PlugReplacetheblankingplatewiththeappropriatemainsplug

adaptorifrequired,oruseIEC60320TYPE7connector

(notsupplied).

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1

Pressreleasebutton

6. Wireless chargers – Standard Lithium

Inserting/replacingthe Battery Pack1.Releasebatterybypressingrelease

buttonasshownandliftbatterypack

fromcradle.

2.Toinsertnewbatterypack,placein

cradleuntilfullyengaged.

2

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6. Wireless chargers – Slimline Lithium-ion

Inserting/replacingthe Battery Pack1.Releasebatterybypressingrelease

buttonasshownandliftbatterypack

fromcradle.

2.Toinsertnewbatterypack,placein

cradleuntilfullyengaged.

1

2

1

2

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Removetheblankingplate

ReplacewithappropriatemainsplugadapterPowerSupply

Connecttocharging/dockingstation

Charging/dockingstation

Charging/dockingstation

Pressreleasebuttonandpushup

Powersupplyinlet

Sparebattery

Sparebattery

6. Wireless chargers

Charging1.Replacetheblankingplatewiththe

appropriatemainsplugadapter,and

connectplugoncabletopowerinput

socketoncharger.

SwitchonyourLithiumChargerby

pluggingitintoamainsoutlet.

2.Placeyoursparebatterypackor

headsetintoyourLithium

Chargerasshown.

1

2

2

NextHome Back

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Chargingsparebattery

Chargingbatteryonheadband

Chargingsparebatteryonly

Chargingbatteryonheadband

6. Wireless chargers

Headband Battery HolderFlashingLED–Batteryrequirescharging.

Charging StationNoindicator–Batteryisfullycharged.

Flashingindicator–TopupCharge.

Solidindicator–RapidCharge.

Thebatterypackcanbeusedatanytime

duringthechargingcycleandwill

automaticallyresumechargingwhen

batterypackisplacedbackinthecharger.

Directionarrowonchargerindicateswhich

batteryisbeingcharged.

Slimline Lithium ion

Standard Lithium

NextHome Back

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6. Wireless chargers

Charging Cycle - Standard LithiumThebatteryattachedtotheindirectwilltakeapproximately

2hourstofullycharge.

Thebatterywilllastapproximately2hoursonfullpower.

Thesparebatterywilltake4hourstocharge.

Charging Cycle - Slimline Lithium ionThebatteryattachedtotheindirectwilltakeapproximately

1½hourstofullycharge.

Thebatterywilllastapproximately1houronfullpower.

Thesparebatterywilltake1½hourstocharge.

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6. Wireless chargers – wall mounting

Usetemplatedocumentprovidedtomark

positionofchargeranddrillholes.

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6. Wireless chargers – wall mounting

1

2

3 4Caution

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7. SmartPack and WallPack

Parts ListA HexKey

B Screws

C Screws

D WallPlugs

E BaseCap

F WallMount

G AdhesivePads

H Rechargeablebattery

PartNo.EP3922079

I Body

J PowerSupply

K AustralianPlug

L UKPlug

MEuroPlug

N USAPlug

B

B

A CD

EF

G

H

I

I

J

K L

M N

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7. SmartPack and WallPack

Set PlugAssemblethepowersupplyaspertheinstructionsinsection6.

Power ConversionConverttoeitherWallPackorSmartPackbyfollowingthe

illustrationbelow.

IEC60320TYPE7connector

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Fixing the Wall MountUsethewallplugsandscrewstomount

thewallpackunit,attachtheadhesive

padstothesideofthecase.

ConnectionInserttheconnectors

intothesockets

asshown.Before

connectingensure

thatboththe

dimmercontrol

andmainsoutlet

areswitchedoff.

30mm

Ø6x50mm

7. SmartPack and WallPack

Charge TimeChargethebatteryfor

12-14hoursbeforeinitialuse.

Note:Theunitbecomeswarm

whencharging,thisisnormal.

Rechargingmaytakeplacewhile

indirectisinuse.Normalbatterylife

is1.5to5hoursdependingon

settingwitharechargetimeoftwo

hoursoroncontinuoustrickle.

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LED Displays

7. SmartPack and WallPack

SlowPulse

FastPulse

LEDOn

LEDOff

Charging

Inuse

TrickleCharging

Batterylow

Power Supply BatteryInsertorremovetheindirectplugorswitch

theindirectoff/on.

Power Supply Mains•SwitchtheindirectON/OFF

•Insertorremovethemainsplug

•Placeonoroffthecradleswitch

•GreenLEDilluminateswhenindirectison

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8. LED/bulb replacement

Caution:

Bulbs/LED’scanreachhightemperaturesinuse–allow

tocoolbeforehandling

UseonlygenuineKeelerapprovedpartsandaccessoriesor

devicesafetyandperformancemaybecompromised

Disconnecttheinstrumentfromtheelectricalsupply.Remove

thebulb/LEDfromthebackoftheinstrumentandinsertthe

replacement,ensuringthatthebulb/LEDkeyisalignedwith

theapertureandsecurelypushedin.

Afterremovalofthe

bulb/LEDdonottouchthe

bulb/LEDcontactsand

thepatientsimultaneously

All Pupil II LEDAllPupiIIIbulbscanbereplacedwith

anLEDlightsourceifrequired.Follow

fittinginstructionsasforbulbs,andas

shownbelow:

Forfurtherdetailsseesection12.

Afterremovalofthe

bulb/LEDdonottouchthe

bulb/LEDcontactsand

thepatientsimultaneously

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9. Cleaning

• Onlymanualnon-immersioncleaningasdescribedshouldbe

usedforthisinstrument

• Donotautoclaveorimmerseincleaningfluids

Alwaysdisconnectpowersupplyfromsource

beforecleaning

a Wipetheexternalsurfacewithacleanabsorbent,non-

sheddingclothdampenedwithawater/detergentsolution

(2%detergentbyvolume)orwater/isopropylalcohol

solution(70%IPAbyvolume).Avoidopticalsurfaces

b Ensurethatexcesssolutiondoesnotentertheinstrument.Use

cautiontoensureclothisnotsaturatedwithsolution

c Surfacesmustbecarefullyhand-driedusingacleannon-

sheddingcloth

d Safelydisposeofusedcleaningmaterials

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10. Specifications and electrical ratings

All Pupil IIInputmainsdata: 100-240V–50/60Hz

Powersupplyrating: 12V:2.5amps

Operation: Continuous

Classification: ClassIIequipment

TypeBprotectionagainstshock

API II LEDVoltage: 6VDC

Lightoutput: Minimum1500LUX(1)

Opticalradiationcomplieswith

BSENISO15004part1:1997

Transport, storage and operating conditionsTransport Storage Operation

Temperaturerange

-40°Cto+70°C

-10°Cto+55°C

+10°Cto+35°C

Relativehumidity

10%to95% 10%to95% 30%to75%

(1)Measuredat440mmfromfrontwindow

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11. Annex I – EMC statement and guidelines

TheKeelerAllPupilIIIndirectOphthalmosopeisamedicalelectrical

instrument.Theinstrumentrequiresspecialcareconcerning

electromagneticcompatibility(EMC).Thissectiondescribesthe

suitabilityintermsofelectromagneticcompatibilityofthisinstrument.

Wheninstallingorusingthisinstrument,pleasereadcarefullyand

observewhatisdescribedhere.

Portableormobile-typeradiofrequencycommunicationunitsmayhave

anadverseeffectonthisinstrument,resultinginmalfunctioning.

Note:TheAPIIILEDisconsideredtobeinherentlyEMCbenign(1),

howeverwhenusedasintendedinconjunctionwiththeAllPupilII

IndirectOphthalmoscope,theEMCrequirementsfortheAPIIIapply,

andmustbeadheredto.

(1)Refertosection1.1.4oftheguidefortheEMCDirective2004/108/EC,published21stMay2007.

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11. Annex I – EMC statement and guidelines

Guidanceandmanufacturer’sdeclaration–electromagneticimmunity

TheKeelerAllPupilIIisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerortheusershouldassurethatitisusedinsuchanenvironment.

Immunitytest IEC60601Testlevel Compliancelevel Electromagneticenvironment-guidance

Electrostaticdischarge(ESD).IEC61000-4-2

±6kVcontact±8kVair

±6kVcontact±8kVair

Floorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.

Electricalfasttransient/burst.IEC61000-4-4

±2kVforpowersupplylines±1kVforinput/outputlines

±2kVforpowersupplylinesN/A

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

Surge.IEC61000-4-5

±1kVline(s)toline(s)±2kVline(s)toearth

±1kVline(s)toline(s)N/A

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

Voltagedips,shortinterruptionsandvoltagevariationsonpowersupplyinputlines.IEC61000-4-11

<5%UT

(>95%dipinUT)for0.5cycles

40%UT

(60%dipinUT)for5cycles

70%UT(30%dipinUT)for25cycles

<5%UT

(>95%dipinUT)for5s

<5%UT

(>95%dipinUT)for0.5cycles

40%UT

(60%dipinUT)for5cycles

70%UT(30%dipinUT)for25cycles

<5%UT

(>95%dipinUT)for5s

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

IftheuseroftheKeelerAllPupilIIrequirescontinuedoperationduringpowermainsinterruptions,itisrecommendedthatthechargerbepoweredfromanuninterruptiblepowersupply.

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

3A/m 3A/m Powerfrequencymagneticfieldsshouldbeatalevelcharacteristicofatypicallocationinatypicalcommercialorhospitalenvironment.

NoteUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.

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11. Annex I – EMC statement and guidelines

Guidanceandmanufacturer’sdeclaration–electromagneticemissions

TheKeelerAllPupilIIisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerorusershouldassurethatitisusedinsuchanenvironment.

Emissionstest Compliance Electromagneticenvironment-guidance

Chargeronly

RFemissionsCISPR11

Group1 TheKeelerAllPupilIIusesRFenergyonlyforitsinternalfunction.Therefore,itsRFemissionsareverylowandarenotlikelytocauseanyinterferenceinnearbyelectronicequipment.

RFemissionsCISPR11

ClassB TheKeelerAllPupilIIissuitableforuseinallestablishments,includingdomesticestablishmentsandthosedirectlyconnectedtothepubliclow-voltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.

HarmonicemissionsIEC61000-3-2

ClassA

Voltagefluctuations/flickeremissionsIEC61000-3-3

Complies

IndirectOphthalmoscopeonly

RFemissionsCISPR15

Complies TheKeelerAllPupilIIisnotsuitableforinterconnectionwithotherequipment.

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11. Annex I – EMC statement and guidelines

Guidanceandmanufacturer’sdeclaration–electromagneticimmunity

TheKeelerAllPupilIIisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerorusershouldassurethatitisusedinsuchanenvironment.

Immunitytest IEC60601Testlevel Compliancelevel Electromagneticenvironment-guidance

ConductedRFIEC61000-4-6

RadiatedRFIEC61000-4-3

3Vrms150kHzto80MHz

3V/m80MHzto2.5GHz

3V

3V/m

PortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartoftheKeelerAllPupilII,includingcables,thantherecommendedseparationdistancescalculatedfromtheequationapplicabletothefrequencyofthetransmitter.

Recommendedseparationdistanced=1.2√p

d=1.2√p80MHzto800MHzd=2.3√p800MHzto2.5GHz

Wherepisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufactureranddistherecommendedseparationdistanceinmetres(m).

FieldstrengthsfromfixedRFtransmitters,asdeterminedbyanelectromagneticsitesurvey¹,shouldbelessthanthecompliancelevelineachfrequencyrange.²

Interferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:

Note1 At80MHzand800MHz,thehigherfrequencyrangeapplies.Note2 Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures, objectsandpeople.¹ Fieldstrengthsfromfixedtransmitters,suchasbasestations(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFM radiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRF transmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheKeelerAllPupilIIis usedexceedstheapplicableRFcompliancelevelabove,theKeelerAllPupilIIshouldbeobservedtoverifynormaloperation.Ifabnormal performanceisobserved,additionalmeasuresmaybenecessary,suchasre-orientatingorrelocatingtheKeelerAllPupilII.²Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

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11. Annex I – EMC statement and guidelines

RecommendedseparationdistancesbetweenportableandmobileRFcommunicationsequipmentandtheKeelerAllPupilII

TheKeelerAllPupilIIisintendedfortheuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomerortheuseroftheKeelerAllPupilIIcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andtheKeelerAllPupilIIasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.

Ratedmaximumoutputpowerof

transmitterW

Separationdistanceaccordingtofrequencyoftransmitterm

150kHzto80MHzd=1.2√p

80MHzto800MHzd=1.2√p

800MHzto2.5GHzd=2.3√p

0.01 0.12 0.12 0.23

0.1 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.

Note1 At80MHzand800MHz,thehigherfrequencyrangeapplies.Note2 Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures, objectsandpeople.

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12. Spare parts and accessories

Thefollowingaccessoriesaretypicalofthosesuppliedinthekits

asindicated:

APIBulbversion,wired(e.g.1204-P-3038)

Wireless,withstandardbatteryandcharger(e.g.1204-P-3041)

Thefollowingitemsareavailableinadditiontotheaccessories

suppliedintheaforementionedkits:

PartnumbersforExpressiOnCliponCoversareonpage37.

Part Number Description

EP09-00755 APIIIcase

EP29-32777 Powersupply

EP39-53748 EyeLensPlano(qty2)

EP39-53799 RubberEyeCap(qty2)

EP79-70059 Softcase

SP90-84030 Screws(qty2)

1201-P-6067 Largedepressor

1201-P-6075 Smalldepressor

1201-P-7000 Chartpad(packof50)

1202-P-7117 APIIIteachingmirror

1299-P-7032 Colouredpencils(packof12)

1945-P-1001* SmartPack

2105-K-1159 20Dlens

2199-P-7136 LensCloth

2415-P-7000 InstructionsforUseCD

3412-P-5100 APIIIaccessorycase

Part Number Description

1012-P-7003 APIIIbulbs(qty2)

1205-P-5014 APIIILED

1919-P-1013 Standardbattery

1919-P-5338 Slimlinebattery

1945-P-5019 Slimlinecharger

3412-P-7000 APIIIcarryingcase

As for 1204-P-3038 example, without 1945-P-1001, but plus:

Part Number Description

EP39-22706 Wallpad

EP59-49013 Wallmounttemplate

EP79-06498 Rawlblocwallplug(qty2)

1012-P-5110 APIIIhalogenbulb

1941-P-5334 Standardcharger

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12. Spare parts and accessories

API II LED

TheAPIIILEDisareplacementlightsourcefortheAllPupilII

IndirectOphthalmoscope.

Followtheguidanceinsection8forfitting.

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12. Spare parts and accessories

Teaching mirror

(A) Removethescrewsfrom

thepanelbeneaththe

frontwindowwiththe

screwdriversupplied.

(B) Fitthemountingbarwith

thepinpointingtothe

rightandsecurewith

screwsremovedinstep(A).

Slidetheteachingmirror

ontothepinonthe

mountingbar.

Theteachingmirrorcannowbe

swivelledupanddown.

Toremove,slidetheteachingmirrortotherightofthepinand

returntoitscaseleavingmountingbarinposition

TomaketheteachingmirrorNon-Removableforsecurity

purposesproceedasfollows:

Removethescrewsasinstep(A).Positionthemountingbarand

replacethescrewonleftsideonly.Fittheteachingmirrorasin

step(B).

FoldtheTeachingMirrordown

andslideittotherighttoreveal

fixinghole.Thensecurethe

mountingbarwiththespecial

washerandpanheadscrew

provided.

Returntheteachingmirrorto

itscentralposition.

Theteachingmirrorcannowbedemountedonlybyremoving

thescrew.Retainthescrewdriver

forfutureuse.

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12. Spare parts and accessories

Eyepiece CapsEyepiececapsareprovidedtoprotectspectaclesandhaverubber

surroundstopreventscratching.Touse,simplyfitoverthe

eyepieces.Replacementsareavailablefromthedistributor(Part

No.EP39-53799).Forfurtherdetailspleaserefertotheaccessory

listsonpage34.

Plano LensesTheKeelerAllPupilIIissuppliedwith+2Dlensesasstandard.

Planolenses,ifpreferred,arealsoavailablefromthedistributor.

TheseareincludedincertainAPIIIkits.Forfurtherdetailsplease

refertotheaccessorylistsonpage34.

ExpressiOn Clip on CoversArangeofdifferentcolourfrontcoversareavailabletofitover

yourIndirect.Tofitthecover,simplypushonuntilthesmall

clipsonthesideandunderneathengagewiththeslotsinthe

mainmouldingasshownindiagram.Pleaseensurethecoveris

fittedcorrectly(asperinstructions)beforeuse.Seeimageto

right.

Theseareavailableinthefollowingcolours:

Red(EP39-25050),LightBlue(EP39-25069)and

DarkBlue(EP39-25077)

DonotuseExpressiOnCliponCoversduringsurgical

procedures

Home

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13. Warranty

Nouserserviceableparts–allpreventativemaintenanceand

servicingmustonlybeperformedbyauthorisedKeeler

representatives.

YourKeelerproductisguaranteedfor3yearsandwillbe

replaced,orrepairedfreeofchargesubjecttothefollowing:-

• Anyfaultduetofaultymanufacture

• Theinstrumentandaccessorieshavebeenusedincompliance

withtheseinstructions

• Proofofpurchaseaccompaniesanyclaim

Pleasenote:

TheAPIIILEDisguaranteedfor5years.

Batteriesarecoveredbythiswarrantystatementfor1yearonly.

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14. Contact and disposal information

Keeler LimitedClewer Hill RoadWindsorBerkshire SL4 4AAEngland

Freephone: 0800 521 251Tel: +44 (0)1753 857177Fax: +44 (0)1753 827145

Keeler Instruments Inc3222 Phoenixville PikeBuilding #50Malvern, PA 19355USA

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

Disposal of old Electrical and Electronic Equipment (Applicable in the European Union and other European Countries with

separate Collection Systems).

This symbol on the product or on its packaging and instructions

indicates that it was put on the market place after August 2005 and

that this product shall not be treated as Household Waste.

To reduce the environmental impact of WEEE (Waste Electrical Electronic

Equipment) and minimise the volume of WEEE entering landfills we

encourage at product end of life that this equipment is recycled and reused.

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

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

EP59-10960 Issue C