Jazz instructions for a CD Final - support.keeler-global.comsupport.keeler-global.com/_manuals/Hand-held Oph, Oto, Ret, Handles... · Home Back Next 7 5. Battery handles and start-up

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Jazz InstrumentsInstructionsforuse

Jazz Instruments

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Contents1. Introduction....................................................................p3

2. Symbols...........................................................................p4

3. Safety

3.1DeviceClassification

3.2Warningsandcautions............................................p5

4. Cleaninginstructions

4.1Sterilisation...............................................................p6

5. Batteryhandlesandstart-up

5.1Purpose

5.2Startupandinsertionandremovalofbatteries

5.3Turningonandoff

5.4Changingthecolourcodedrings............................p7

6. Otoscopeandaccessories

6.1Purpose

6.2Insertionandremovalofearspeculum

6.3Introductionofexternalinstrumentsintotheear..p8

6.4ReplacementofLED

6.5SpareLEDs

6.6Sparerings................................................................p8

7. Ophthalmoscopeandaccessories

7.1Purpose

7.2Lenswheelandcorrectinglenses

7.3Aperturesandfilters................................................p9

7.4Bulb/LEDreplacement

7.5SpareBulbs/LEDs

7.6Sparerings..............................................................p10

8. Maintenance.................................................................p11

9. Specificationsandelectricalratings.......................p12-18

10.Warranty.......................................................................p19

11.Contact,packaginganddisposalinformation...........p20

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Aspartofourpolicyforcontinuedproductdevelopmentwereservetherighttoamendspecificationsatanytimewithoutpriornotice.

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1. IntroductionThank you for purchasing your Keeler Jazz Instruments.

Manufactured in compliance with Directive 93/42/EEC for

medical products.

Please read and follow these instructions carefully.

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2. Symbols ReaduserinstructionsforWarnings,Cautionsand

additionalinformation

TheCEmarkonthisproductindicatesithasbeen

testedtoandconformswiththeprovisionsnoted

withinthe93/42/EECMedicalDeviceDirective

Consultinstructionsforuse

Manufacturersnameandaddress

Keepdry

TypeBprotectionsagainstshock

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3. Safety

3.1 Device Classification

CE Regulation 93/42 EEC: Class 1

3.2 Warnings and cautions

Warning

• Please read these instructions carefully prior to use and keep

in a safe place. Should you have any queries, please contact

your supplier or your Keeler Agent who will be pleased to

assist you. For addresses please see the back page of these

instructions. The address of your authorised Keeler Agent can

be supplied on request.

• Please note that any instruments described in these

instructions are only suited for application by trained

operators.

• Correct and safe operation of instruments will only be

guaranteed when Keeler instruments and accessories are used

throughout.

• Do not use if the product is visibly damaged and periodically

inspect for signs of damage.

• Do not use in the presence of flammable gases or an oxygen

rich environment

• This product should not be immersed in fluids.

• Batteries must be inserted as per instructions - see section 5.2

• No modification to this equipment is allowed.

• Do not touch battery terminals and patient simultaneously.

• Instrument may become hot if used for extended periods

of time.

Caution

• The product has been designed to function safely when at an

ambient temperature between +10ºC and +35ºC.

• Keep out of the reach of children.

• To prevent condensation from forming, allow instrument to

come to room temperature before use.

• Bulbs/LEDs become hot during use, caution should be taken

when replacing bulbs/LEDs.

• The light emitted from this instrument is potentially

hazardous. The longer the duration of exposure, the

greater the risk of ocular damage. Exposure to light from this

instrument when operated at maximum

intensity will exceed the safety

guideline after 30 minutes.

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4. Cleaning instructionsOnlymanualnon-immersioncleaningasdescribedshould

beusedforthisinstrument.Donotautoclaveorimmersein

cleaningfluids.

a Wipetheexternalsurfacewithacleanabsorbent,non-

sheddingclothdampenedwithawater/detergentsolution

(2%detergentbyvolume)orwater/isopropylalcohol

solution(70%IPAbyvolume).Avoidopticalsurfaces.

b Ensurethatexcesssolutiondoesnotentertheinstrument.

Usecautiontoensureclothisnotsaturatedwithsolution.

c Surfacesmustbecarefullyhand-driedusingacleannon-

sheddingcloth.

d Safelydisposeofusedcleaningmaterials.

4.1 SterilisationKeelerrecommendthatearspeculumareusedonce.

However,theearspeculummaybesterilisedat134°foradwell

timeof10minutesinasteamsteriliser.

Singleuse-repeatedusecouldcauseinfection.

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5. Battery handles and start-up5.1 PurposeKeelerbatteryhandlesarefittedtotheKeelerJazz

OphthalmoscopeandJazzOtoscope.

5.2 Start up and insertion and removal of batteriesUnscrewtheJazzinstrumentheadfromthehandlein

ananti-clockwisedirection.Inserttwocommercialtype‘AA’

alkalinebatteriesof1.5V(IECstandardreferenceLR6)intothe

caseofthehandlewiththetwopluspolestowardstheupper

sectionofthehandle.

Warning:

• Shouldtheunitnotbeusedforanextendedperiodoftime

orwhilsttravelling,removebatteriesfromthehandle.

• Insertnewbatterieswhenlightintensityoftheunitis

reduced,thusaffectingexamination.

• Formaximumlightyielditisrecommendedtoalwaysinsert

newhigh-qualitybatteriesonreplacement.

• Neverimmersehandlesinfluid.Ensurethatnofluidor

condensationpenetratesintothehandle.

DisposalPleasenotethatbatteriesaresubjecttoseparatedisposal.

Fordetailsaskyourlocalauthorityand/oryourenvironmental

officer.

5.3 Turning on and offThehandleisequippedwithan

On/Offswitch.Whenintheupposition,

theunitisswitchedon,wheninthe

downposition,theunitisoff.ON

OFF

ON

OFF

Unscrewanti-clockwise

Screwonclockwise

5.4 Changing the colour coded ringsUnscrewtheJazzinstrumentheadfromthe

handleinananti-clockwisedirection.Remove

theexistingringandreplacewithanewringin

thecolourofyourchoice.Screwtheinstrument

headsbackoninaclockwisedirection.

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6. Otoscope and accessories6.1 PurposeKeeler Jazz Otoscopes described in these instructions have been

produced for lighting and examination of the auditory canal,

combined with Keeler ear speculum.

6.2 Insertion and removal of ear speculumPosition the selected speculum on

the chromium plated metal cone

of the otoscope. Turn speculum to

the right until resistance is felt. The

size of the speculum is marked on the

outer surface.

6.3 Introduction of externalinstruments into the earWhen intending to introduce external

instruments into the ear (such as

forceps), turn magnifying lens (approx

2.5X enlargement) on otoscope head in

anti- clockwise direction. Replace cover

lens in reverse direction.

6.4 Replacement of LEDRemove instrument head from battery handle.

The LED is in the bottom section of the

instrument head. Remove LED, by using your

thumb and forefinger or a suitable tool,

from instrument head. Firmly insert new LED.

Caution:

• LED may be hot

• Speculum are Applied Parts

6.5 Spare LEDs1015-P-5298 Jazz Otoscope LED

6.6 Spare ringsEP39-37051 Black

EP39-37342 Pink

EP39-37350 Blue

6.3 Introduction of external

When intending to introduce external

instruments into the ear (such as

forceps), turn magnifying lens (approx

2.5X enlargement) on otoscope head in

anti- clockwise direction. Replace cover

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7.1 PurposeKeelerJazzOphthalmoscopesdescribedintheseinstructions

havebeendesignedfortheexaminationoftheeyeandits

background.

7.2 Lens wheel and correcting lensesThecorrectinglensesmaybeadjustedon

thelenswheel.

Thefollowingcorrectinglensesareavailable:

diopters0to+20and0to-20.Readingswillbe

displayedonalitpanel.Plusvaluesaredisplayed

inblackdigitsandminusvaluesinreddigits.

7.3 Apertures and filtersThefollowingaperturesand/orfiltersmaybe

selectedbytheapertureandfilterwheel:

7.2 Lens wheel and correcting lenses

Thefollowingcorrectinglensesareavailable:

diopters0to+20and0to-20.Readingswillbe

displayedonalitpanel.Plusvaluesaredisplayed

inblackdigitsandminusvaluesinreddigits.

7. Ophthalmoscope and accessories

Aperture Function

Small Circle Designedspecificallyforexamination ofthemacularregionofthefundus wherealargerbeamwouldcreate excessivepapillaryreactionor patientcomfort

Semi-circle Forreductionofreflexesofsmallpupils

Large Circle Forstandardfundusexamination

Fixation Star Fordefinitionofcentralandeccentric fixation

Red-free filter Toincreasecontrastforassessmentof changesinfinevessels,i.e. retinalhaemorrhages

Cobalt Blue filter Usedwithfluoresceindyeforthe detectionandexaminationofcorneal scarsandabrasions

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7.4 Bulb/LED replacementRemoveinstrumentheadfrombatteryhandle.

Thebulb/LEDislocatedinthebottomsectionof

theinstrumenthead.Removebulb/LEDfromthe

instrumenthead,byusingyourthumband

forefinger.Insertnewbulb/LEDwiththepinon

thebulb/LEDfittedintherecess/slotprovided

onthebaseoftheinstrument.

Warning:

•Thebulb/LEDmaybehot

7.5 Spare Bulbs/LEDs1011-P-5530JazzOphthalmoscopeBulb

1011-P-5522JazzOphthalmoscopeLED(Notavailablein

EuropeorUSA)

7.6 Spare ringsEP39-37051 Black

EP39-37342 Pink

EP39-37350 Blue

Removeinstrumentheadfrombatteryhandle.

Thebulb/LEDislocatedinthebottomsectionof

theinstrumenthead.Removebulb/LEDfromthe

forefinger.Insertnewbulb/LEDwiththepinon

7. Ophthalmoscope and accessories

thebulb/LEDfittedintherecess/slotprovided

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8. MaintenanceJazzinstrumentsandtheiraccessoriesdonotrequire

anyspecificmaintenance.Shouldaninstrumenthave

tobeexaminedforanyreason,pleasereturnitto

yoursupplieroranauthoriseddealerin

yourarea.Addressescanbesupplied

onrequestorvisitwww.keeler.co.uk.

Jazzinstrumentsandtheiraccessoriesdonotrequire

anyspecificmaintenance.Shouldaninstrumenthave

tobeexaminedforanyreason,pleasereturnitto

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9. Specifications and electrical ratings

Dimensions Otoscope - 18cmx3cmx7.5cm(HxDxW)(includinghandleandspeculum) Ophthalmoscope - 18cmx3cmx3cm(HxDxW)(includinghandle)

Weight Otoscope - 96gm(includinghandlewithoutbatteries) Ophthalmoscope - 87gm(includinghandlewithoutbatteries)

Apertures SmallCircle,Semi-circle,LargeCircle,FixationStar,Red-freefilter, CobaltBluefilter(seepage9)

Diopters 0to+20and0to-20(seepage9)

Complies with ElectricalSafety(Medical)BSEN60601-1:2006 ElectromagneticcompatibilityEN60601-1-2:2007 Ophthalmicinstruments-fundamentalrequirementsandtestmethodsISO15004-1:2006 OpticalradiationhazardISO15004-2:2007

Environment Temperature Humidity Pressure Use: +10°Cto+35°C 30%to90% 800hpato1060hpa Storage: -10°Cto+55°C 10%to95% 700hpato1060hpa Transport: -40°Cto+70°C 10%to95% 500hpato1060hpa

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Caution

•PC-LED - Thelightemittedfromthisinstrumentispotentially

hazardous.Thelongerthedurationofexposure,thegreaterthe

riskofoculardamage.Exposuretolightfromthisinstrument

whenoperatedatmaximumintensitywillexceedthesafety

guidelineafter30minutes.

•Halogen bulb - Thelightemittedfromthisinstrumentis

potentiallyhazardous.Thelongerthedurationofexposure,the

greatertheriskofoculardamage.Exposuretolightfromthis

instrumentwhenoperatedatmaximumintensitywillexceedthe

safetyguidelineafter30minutes.

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Guidance and manufacturer’s declaration - electromagnetic compatibility

TheJazzOtoscopeandOphthalmoscopehavebeentestedregarding

theirabilitytooperateinanenvironmentcontainingotherelectrical/

electronicequipment(includingothermedicaldevices).

ThepurposeofthistestingistoensuretheJazzOtoscopeand

Ophthalmoscopearenotlikelytoadverselyaffectthenormal

operationofothersuchequipmentandthatothersuchequipment

isnotlikelytoadverselyaffectthenormaloperationoftheJazz

OtoscopeandOphthalmoscope.

DespitethetestingoftheJazzOtoscopeandOphthalmoscope

thathasbeenundertaken,normaloperationoftheJazzOtoscope

andOphthalmoscopecanbeaffectedbyotherelectrical/electronic

equipmentandportableandmobileRFcommunicationsequipment.

AstheJazzOtoscopeandOphthalmoscopeareclassedasmedical

equipment,specialprecautionsareneededregardingEMC

(electromagneticcompatibility).

ItisimportantthattheJazzOtoscopeandOphthalmoscopeare

configuredandinstalled/putintoservice,inaccordancewiththe

instructions/guidanceprovidedhereinandareusedonlyinthe

configurationassupplied.

TheJazzOtoscopeandOphthalmoscopehavebeentested(andshould

beusedonlywith)theJazzbatteryhandleandlampsupplied.

IftheJazzOtoscopeandOphthalmoscopeareusedwithbattery

handlesotherthantheonesupplied,orwithlampsotherthanthose

recommended,thismayresultinincreasedemissionsordecreased

immunityoftheJazzOtoscopeandOphthalmoscope,inrelationto

EMCperformance.

ItshouldbenotedthattheJazzbatteryhandleandlampsprovided

withtheJazzOtoscopeandOphthalmoscopeshouldnotbeused

onotherequipment.Todosomayresultinincreasedemissionsor

decreasedimmunityoftheotherequipmentinrelationtoEMC

performance.

TheJazzOtoscopeandOphthalmoscopeshouldnotbeusedadjacent

toorstackedwithotherequipment.Ifadjacentorstackedusewith

otherequipmentisnecessary,theJazzOtoscopeandOphthalmoscope

andtheotherequipmentshouldbeobserved/monitored,toverify

normaloperationintheconfigurationinwhichitwillbeused.

ForthepurposesofEN60601-1-2,theJazzOtoscopeand

Ophthalmoscopehaveanessential

performance.Thisessentialperformance

isthatthelightoutputshould

remainon.

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Guidance and manufacturer’s declaration – electromagnetic emissions

TheJazzOtoscope/Ophthalmoscopeisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheJazzOtoscope/Ophthalmoscopeshouldassurethatitisusedinsuchanenvironment.

Emissions test Compliance Electromagnetic environment - guidance

RFemissionsCISPR11

Group1 TheJazzOtoscope/OphthalmoscopeusesRFenergyonlyforitsinternalfunction.Therefore,itsRFemissionsareverylowandarenotlikelytocauseanyinterferenceinnearbyelectronicequipment.

RFemissionsCISPR11

ClassB TheJazzOtoscope/Ophthalmoscopeissuitableforuseinallestablishments,includingdomesticestablishmentsandthosedirectlyconnectedtothepubliclow-voltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.

HarmonicemissionsIEC61000-3-2

NotApplicable

Voltagefluctuations/flickeremissionsIEC61000-3-3

NotApplicable

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Guidance and manufacturer’s declaration – electromagnetic immunity


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

Electrostaticdischarge(ESD)IEC61000-4-2

±6kVcontact±8kVair

±6kVcontact±8kVair

Floorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.

Electricalfasttransient/burstIEC61000-4-4

±2kVforpowersupplylines±1kVforinput/outputlines

NotApplicable Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

SurgeIEC61000-4-5

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


Voltagedips,shortinterruptionsandvoltagevariationsonpowersupplyinputlinesIEC61000-4-11

<5%UT(>95%dipinUT)for0.5cycle

40%UT(60%dipinUT)for5cycles

70%UT(30%dipinUT)for25cycles

<5%UT(>95%dipinUT)for5s


Powerfrequency(50/60Hz)magneticfieldIEC61000-4-8

3A/m 3A/m Ifincorrectoperationoccurs,itmaybenecessarytopositiontheJazzOtoscope/Ophthalmoscopefurtherfromsourcesofpowerfrequencymagneticfieldsortoinstallmagneticshielding.Thepowerfrequencymagneticfieldshouldbemeasuredintheintendedinstallationlocationtoassurethatitissufficientlylow.

NoteUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.

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Guidance and manufacturer’s declaration – electromagnetic immunity


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

ConductedRFIEC61000-4-6

RadiatedRFIEC61000-4-3

3Vrms150kHzto80MHz

3V/m80MHzto2.5GHz

NotApplicable

3V/m

PortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartoftheJazzOtoscope/Ophthalmoscope,includingcables,thantherecommendedseparationdistancecalculatedfromtheequationapplicabletothefrequencyofthetransmitter.

Recommended separation distance (d)d=1.2√P

d=1.2√P80MHzto800MHz

d=2.3√P800MHzto2.5GHz

WherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufactureranddistherecommendedseparationdistanceinmetres(m).

FieldsstrengthsfromfixedRFtransmitters,asdeterminedbyanelectromagneticsitesurvey,ashouldbelessthanthecompliancelevelineachfrequencyrange.b

Interferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:

Note 1 At80MHzand800MHz,thehigherfrequencyrangeapplies.Note 2 Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objects andpeople.a Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AM andFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.Toassesstheelectromagneticenvironmentduetofixed RFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheJazzOtoscope/ OphthalmoscopeisusedexceedstheapplicableRFcompliancelevelabove,theJazzOtoscope/Ophthalmoscopeshouldbeobservedtoverify normaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasre-orientatingorrelocatingtheJazz Otoscope/Ophthalmoscope.b Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

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Recommended separation distances between portable and mobile RF communications equipment and the Jazz Otoscope / Ophthalmoscope

TheJazzOtoscope/OphthalmoscopeisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomerortheuseroftheJazzOtoscope/OphthalmoscopecanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andtheJazzOtoscope/Ophthalmoscopeasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.

Rated maximum output power of

transmitterW

Separation distance according to frequency of transmitterm

150kHzto80MHz

d=1.2√P

80MHzto800MHz

d=1.2√P

800MHzto2.5GHz

d=2.3√P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23.3

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmetres(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.

Note 1 At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.Note 2 Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructuresobjects andpeople.

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10. WarrantyNouserserviceableparts–allpreventativemaintenance

andservicingmustonlybeperformedbyauthorisedKeeler

representatives.

YourKeelerproductisguaranteedfor3yearsandwillbereplaced,

orrepairedfreeofchargesubjecttothefollowing:-

• Anyfaultduetofaultymanufacture

• Thedevicehasbeenusedincompliancewith

theseinstructions

• Proofofpurchaseaccompaniesanyclaim.

Bulbs/LEDsareguaranteedfor1yearfromdateofpurchase.

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11. Contact, packaging and disposal information

EP59-33839 Issue 3

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).

ManufacturerKeeler Limited Clewer Hill RoadWindsorBerkshireSL4 4AA

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

USA Sales OfficeKeeler Instruments Inc3222 Phoenixville PikeBuilding #50Malvern, PA 19355USA

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

Documents

Jazz instructions for a CD Final - support.keeler-global.comsupport.keeler-global.com/_manuals/Hand-held Oph, Oto, Ret, Handles... · Home Back Next 7 5. Battery handles and start-up