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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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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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9. Specifications and electrical ratings
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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9. Specifications and electrical ratings
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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9. Specifications and electrical ratings
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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9. Specifications and electrical ratings
Guidance and manufacturer’s declaration – electromagnetic immunity
TheJazzOtoscope/Ophthalmoscopeisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheJazzOtoscope/Ophthalmoscopeshouldassurethatitisusedinsuchanenvironment.
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
NotApplicable Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.
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
NotApplicable Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.
Powerfrequency(50/60Hz)magneticfieldIEC61000-4-8
3A/m 3A/m Ifincorrectoperationoccurs,itmaybenecessarytopositiontheJazzOtoscope/Ophthalmoscopefurtherfromsourcesofpowerfrequencymagneticfieldsortoinstallmagneticshielding.Thepowerfrequencymagneticfieldshouldbemeasuredintheintendedinstallationlocationtoassurethatitissufficientlylow.
NoteUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.
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9. Specifications and electrical ratings
Guidance and manufacturer’s declaration – electromagnetic immunity
TheJazzOtoscope/Ophthalmoscopeisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheJazzOtoscope/Ophthalmoscopeshouldassurethatitisusedinsuchanenvironment.
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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9. Specifications and electrical ratings
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