Horus+ ScopeEOC 100 Digital Otoscope

User Manual

DOC. No. 2014.02-A

Copyright@2014 MiiS Inc. All right reserved.

1. Category 12. Symbols 23. Warnings and Cautions 34. Intended for Use 85. User Interface 96. Operating Instructions 117. Battery Charging and Photo

Transferring 128. Battery Replacement 139. Cleaning and Disinfection 1410. Operation Environment 1511. Environment for Storage and

Transportation 1512. Technical Description 1613. Liability 1714. Environment 1815. Standards 19

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1. Category

Model Name MiiS Horus+ Scope EOC 100

Product Name Digital Otoscope

Accessory 1.Battery 2. Disposable Specula a.) adult x 8 b.) pediatric x 8 3. Power Adapter 4. USB Cable 5. AV Cable

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2. Symbols

Cautionmustbetaken.Readuser’smanualbeforeuse.

TypeBF- Indicatesthedevice isclassifiedasadevicewith a Type BF applied part.Theoperator isadvised to read the instructionsofuser’smanual.

Manufacturer.

DateofManufacture.

CEmark.

EuropeanAuthorizedRepresentative.

This product is a rechargeable internal Class II power supply.

3. Warnings and Cautions

NOTEPrior to installationandstart-upof thedevice,carefully readtheinstructionsprovidedherein!Aswithalltechnicaldevices,theproperfunctionandsafetyoperationofthisdevicedependontheuser’scompliancewiththesafetyrecommendationswhicharepresentedintheseoperatinginstructions.Donotattempttoopenthecoveroftheproduct,soastoavoidmalfunctionofproduct.

CAUTION

AlwaysusethedeviceinaccordancewiththedirectionsandrecommendationscontainedinthisUserManual.Operatethedevice,pleasetakenotethatoptical lensdonottouchtheeyesornoseofpatient.Avoidharmtopatient.Topreventfireorelectricalshock,donotexposetheseappliances to rain or moisture.Thisdevice isnotwaterproof. If theoptical lensandcontrolunitgetwet;donotattempttodrywithaheater,microwave,autoclaveorUVlight.

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Avoidsubjectingthedevicetovibrationorshock.Whentheproduct isnot inuse,pleasedisconnectthepowerplugandkeepitinasafeplace.Avoidusingthedeviceinadustyenvironment,andkeepthepowercordawayfromanyheatsource.Beforeoperation,pleasemakesuretheappearanceisnotdamagedorbroken.Iftherearebreaksinthedevicecov-erorothervisualdefects,pleasecontactmanufacturerormanufacturercertifiedservicefacility.Pleasedonotchargethebatterywhenthedeviceisoper-ated by the user.OnlyuseLi-ionBattery3.7V@2600mAhwhichshallbeprovidedbythemanufacturerordistributors.Thebatteryhasdesignedtheprotectioncircuit.Toensurethesafetyoftheproductoperation, ifthebatteryreacheslifetimeorfailure,pleasecontactthemanufacturerordistributortobuythesparebattery.IfyoupurchasedifferentmemorycapacityofMicroSDCard,mustbeprecededformattoFAT32.Theeyecan’tbeexposedtotheilluminationlightoftheproductatoperation.ReplacethedisposablespeculaofHorus+ScopeEOC100,DigitalOtoscope,beforeeachuseforanewpatient.

Gently insertthespeculaofHorus+ScopeEOC100intoearcanal.Tokeepasafetydistancebetweenthespeculaandtympanicmembrane.Donotmakethespeculacon-tactwithear’stympanicmembrane.Nomodificationof thisdevice isallowed.Theperfor-mancewouldbechangedifmodifythisdevicebyuser.Modificationtothisdevicemaycausehazardousradiationexposure.

ThisdevicehasbeentestedandfoundtocomplywiththelimitsformedicaldevicestotheIEC60601-1-2:2007.These limits are designed to provide reasonable protec-tionagainstharmful interference inastandardmedicalinstallation.Ifthisdevicedoescauseharmfulinterferencetootherdevices,whichcanbedeterminedbyturningthesystemoffandon,theuser isencouragedtotrytocorrecttheinterferencebyoneormoreofthefollowingmeasures:

• Reorientorrelocatethereceivingdevice• Increasetheseparationbetweenthesystemand

other devices.• Connectthedevicetoanoutletonacircuitdif-

ferentfromthattowhichtheotherdevice(s)areconnected.

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• Consultthemanufacturerorfieldservicetechni-cianforhelp.

The International Electrotechnical Commission sets the essential requirements forelectrical and electronicequipmentthatmaydisturb,orbedisturbedby,otherequipment.The device complies with these requirements as shown inthetablesin“15.(1)EMC(ElectromagneticCompatibil-ity)”(Page13-16).Followtheguidanceinthetablesforuseofthedeviceinanelectromagneticenvironment.Duringinstallationandoperationofthedevice,observethefollowing instructionsaboutEMC(electromagneticcompatibility):

• Do not use the device simultaneously with other electronic equipment to avoid

• electromagneticinterferencewiththeoperationofthe device.

• Donotuseorstackthedevicenear,on,orunderother electronic equipment to avoid electromag-neticinterferencewiththeoperationofthedevice.

• Do not use the device in the same room as other electronicequipmentsuchas life-supportequip-ment,equipmentthathasmajoreffectsonthelifeofthepatientandresultsoftreatment,oranyother measurement or treatment equipment that involves small electric current.

• Do not use the system with portable and mobile radiofrequencycommunicationsystemsbecausethatmayhaveanadverseeffectonoperationofthe device.

• Do not use cables or accessories that are not specifiedforthedevicebecausethatmayincreasetheemissionofelectromagneticwavesfromthedeviceanddecreasetheimmunityofthedevicetoelectromagneticdisturbance.

• Donottouchlensconnectingpinsofcontrolunit,orsignalpadoflenseswithoutspecialprecautions.

Usersareresponsibleformanagingcapturedimagedata.Manufacturerwillnotassumeanyresponsibilityfor lossofdata.

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4. Intended for Use

EOC 100 is a digital hand-held otoscope used to record digital photo-graphsandvideoofthehumanear’scanalandtympanicmembrane.EOC100canalsobeusedatgeneral Inspectionofthroatandnasalcavity and capture the photographs and video.

5. User Interface

Powerbutton

Interface ofspecula

Focus wheel

Batterycover

Insufflationport

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6. Operating Instructions

SD Card slot

AV outMini USB out

Attaching / removing directionofthespecula

13:24:122014/04/16

5B 1234M1

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3

4

5

6

10

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1.OperationMode:PhotoVideoDisplay

2. Brightness indicator3. Free memory

ofSDCard4. Power indicator5. Date indicator6.Timeindicator

7.Brightnessdecreasing/Functionselection

8. MENU9. Brightness increasing/

Functionselection

10.StatusIndicator:BlueLED-NormalOperationOrange LED- In charging

11.CaptureButton

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7. Battery Charging and Photo Transferring

Battery Charging:Step1. Connect the EOC 100 and power adapter via USB cable.Step2. Insertthepoweradapterintothewallplugforcharging.

Photo Transferring:Connect the EOC 100 and computer via USB cable. At normal situa-tion,EOC100becomesastandardstoragedevice,usercanrevieworcopythephotosfromthisdevicetothecomputer.

NOTEEOC 100 can also operate at “UVC” mode. It means the pictures can beshownatLCDpanelofEOC100andthescreenofthecomputerifEOC 100 is connected to computer via USB cable.Userwanttooperateat“UVC”mode,pleaseenterthemenutoen-ablethisfunction.

8. Battery Replacement

BatteryReplacement

Openthebatterycoverbydiggingoutthegapinthebottomofbat-terycoverwithafingerorsomethingpointed.

• Tiltthebatterycoverandremovethebatterycoverbyliftingitup.

• Removetheoriginalbatteryandreplaceanewbatteryalongthecorrectdirection.

• Placethebatterycoverandsecureitinplace.

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9. Cleaning and Disinfection

The device is a precision photoelectronic instrument that shall be handledwithspecificcare.Pleasenotefollowingcleaning instruc-tions:

• Poweroffdevicebeforecleaningit.• Disinfect theproductwiththesoftclothwithalcohol (70%

ethyl alcohol).• Itisrecommendedtocleantheopticallenswithcleaningcloth

orlenscleaningtissuesuchasTHORLABInc.,(www.thorlabs.com) Lens Cleaning Tissue.

Ifthereplacementfornewdisposablespecula,pleasecontactwithmanufactureroryourownretailer.

NOTEThe device is not intended to be sterilized

10. Operation Environment

• Ambienttemperature: 0°Cto+35°C• Relativehumidity: 10%to80%• Atmosphericpressure: 700hPa~1060hPa

11. Environment for Storage and Transportation

• Ambienttemperature: -10°Cto+40°C• Relativehumidityrange: 10%to95%

NOTEItisrecommendedtoremovethebatteryifthedeviceisstoredover2weeks.

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12. Technical Description

• FocusRange 25~100mm(Typical)• Dimension 180x70x70mm3(Typical)• Weight 200Grams(Typical)• Camera/Video NaturalWhiteLightEmittingDiode(LED)

Focus: Manual FocusCameraResolution: 1920 x 1080 pixelsScreen: TFT-LCDImageFormat: JPEG (Photograph) and

H.264(Video)Interface: MiniUSB,AVoutportFileTransfer: Mini USB Port to PCDynamicVideoOutput: CompositeAVout,orUSB

livevideoenablefromUSBport

Filestorage: SDCard,default8GB.Sup-ports 2G to 32GB by FAT32 Format

PowerSource: RechargeableLithiumBat-tery3.7V/2600mAh

ExternalPower: Source : 100~240 VAC,50/60Hz

Poweradapteroutputspec: 5VDC,1.2AOperatingtime: 3hoursat2.5Wattcondi-

tionChargingtime: 5 hoursExpectedservicelife:(definedbymanufacturer)

5 years from thedateofinitialoperation*Proper maintenance is necessary

13. Liability

Manufacturerconsiders itselfresponsiblefortheeffectsonsafety,reliabilityandperformanceofthedeviceonlyif:

• Assemblyoperations,extensions, re-adjustments,modifica-tionsorrepairsarecarriedoutbypersonsauthorized.

• Theelectrical installationoftherelevantroomcomplieswiththe requirements.

• Theequipmentisusedinaccordancewiththeseinstructionsforuse.

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14. Environment

• Follow the local governing ordinances and recycling plans re-gardingdisposalorrecyclingofdevicecomponents.Especiallywhendisposingofthelithiumionbattery,circuitboard,plasticpartsthatcontainbrominatedflameretardant,LCD,orpowercord,besuretofollowthelocalgoverningordinances.

• Follow the local governing ordinances and recycling plans whendisposingofthecircuitboardwiththelithiumbattery.Inappropriate disposal may contaminate the environment.

• Whendisposingofpackingmaterials,sortthembymaterialandfollowlocalordinancesandrecyclingregulations.

• Inappropriate disposal may contaminate the environment.• Whendisposingofeyecup,followthedisposalproceduresfor

medicalwastesuchasneedles, infusiontubes,metal instru-mentsforsurgeryasspecifiedbyyourmedicalfacilitytoavoidinfectionoutsidethefacilityandenvironmentalpollution.

15. Standards

Electricalsafety IEC60601-1:2005 (EN60601-1:2006)

EMC and regulatory compliance

IEC60601-1-2:2007 (EN60601-1-2:2007)

• Equipmentconnectedtotheanalogordigital interfacesmustbe certifiedaccording to the representative appropriatenational standards (suchasEN60601-1and IEC60601-1).Furthermore,allconfigurationsshallcomplywiththesystemstandardIEC60601-1.Anyonewhoconnectsadditionalequip-menttothesignal inputpartorsignaloutputpartconfiguresamedicalsystem,andisthereforeresponsiblethatthesystemcomplieswiththerequirementsofthesystemstandard IEC60601-1.Ifindoubt,consultthetechnicalservicedepartmentofyourlocalrepresentative.

EMC (Electromagnetic Compatibility)ThedevicecomplieswiththeInternationalElectrotechnicalCommis-sionstandards(IEC6060112:2007)forelectromagneticcompatibilityaslistedinthetablesbelow.Followtheguidanceinthetablesforuseofthedeviceinanelectromagneticenvironment.

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EMC (IEC 60601 1 2: 2007)

Guidance and manufacturer’s declara-tion electromagnetic emissions

Thedeviceisintendedforuseintheelectromagneticenviron-mentspecifiedbelow.Thecustomerortheuserofthedevice

should assure that it is used in such an environment.

Emissions test Compliance Electromagneticenvi-ronment guidance

RFemissionsCISPR11

Group 1 ThedeviceusesRFenergyonlyfor its internal function.There-fore,itsRFemissionsareverylowandarenot likely tocauseanyinterferenceinnearbyelectronicequipment.

RFemissionsCISPR11

Class B Thedevice issuitableforuse inallestablishments, includingdo-mesticestablishmentsandthosedirectly connected to the public lowvoltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.

Harmonic emissionsIEC6100032

*1

Voltagefluctuations/Flick-eremissionsIEC6100033

*2

*1Fortheregionswheretheratedvoltageis220Vorgreater,thisdevicecomplieswithclassA.Fortheregionswheretheratedvoltageis127Vorless,thisstandardis not applicable.

*2Fortheregionswheretheratedvoltageis220Vorgreater,thisdevicecomplieswiththisstandard.Fortheregionswheretheratedvoltageis127Vor less,thisstandard is not applicable.

Guidance and manufacturer’s declara-tion electromagnetic immunity

Thedeviceisintendedforuseintheelectromagneticenviron-mentspecifiedbelow.Thecustomerortheuserofthedevice

should assure that it is used in such an environment.

Immunity test IEC60601test level

Compli-ance level

Electromag-neticenviron-

ment guidanceElectrostaticDischarge(ESD)IEC6100042

±6kVcontact±8kVair

±6kVcontact±8kVair

Floor should be wood,concreteorceramictile.Iffloorsarecoveredwithsyntheticma-terial,therelativehumidity should beatleast30%.

Electricalfasttransient/burst IEC6100044

±2kVforpowersupply lines±1kVforinput/output lines

±2kVforpowersupply lines±1kVforinput/output lines

Mains power quality should be thatofatypicalcommercial or hos-pital environment.

SurgeIEC6100045

±1kVdifferentialmode±2kVcommon mode

±1kVdifferentialmode±2kVcommon mode

Mains power quality should be thatofatypicalcommercial or hos-pital environment.

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Voltage,dips,shortinterruptionsandvoltagevariationson power supply input linesIEC61000411

<5%UT (>95%dipinUT)for0.5cycle40%UT(60%dipinUT)for5cycles70%UT(30%dipinUT)for25cycles<5%UT(>95%dipinUT)for5sec

<5%UT(>95%dipinUT)for0.5cycle40%UT(60%dipinUT)for5cycles70%UT(30%dipinUT)for25cycles<5%UT(>95%dipinUT)for5sec

Mains power qual-ity should be that ofatypicalcom-mercial or hospital environment.Iftheuserofthedevicerequirescontinuedoperationduringpower mains interruptions,itisrecommended that the device be pow-eredfromanunin-terruptiblepowersupplyorabattery.

Powerfrequency(50/60Hz)mag-neticfieldIEC6100048

3 A/m 3 A/m Powerfrequencymagneticfieldsshould be at levels characteristicofatypicallocationin a typical com-mercial or hospital environment

NOTE:UTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.

Guidance and manufacturer’s declara-tion electromagnetic immunity

Thedeviceisintendedforuseintheelectromagneticenviron-mentspecifiedbelow.Thecustomerortheuserofthedevice

should assure that it is used in such an environment.

Immu-nity test

IEC60601test level

Compli-ance level

Electromagneticenviron-ment guidance

Con-ductedRFIEC 6100046

RadiatedRFIEC 6100043

3 Vrms150kHzto80 MHz

3 V/m80 MHz to 2.5 GHz

3 Vrms(V1=3)

3 V/m(E1=3)

PortableandmobileRFcommunicationsequipment should be used no closer to anypartofthedevice,includingcables,thantherecommendedseparationdis-tancecalculatedfromtheequationappli-cabletothefrequencyofthetransmitter.Recommended separation distanced=1.2 150kHzto80MHz

d=1.2 80 MHz to 800 MHzd=2.3 800 MHz to 2.5 GHzwhere P is the maximum output powerratingofthetransmitterinwatts(W)accordingtothetransmittermanufactureranddistherecommendedseparationdistanceinmeters(m).FieldstrengthsfromfixedRFtransmitters,asdeterminedbyanelectromagneticsitesurvey,a should be less than the compli-ancelevelineachfrequencyrange.b

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Interferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:

NOTE1:At80MHzand800MHz,thehigherfrequencyrangeapplies.NOTE2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropaga-tionisaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.aFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichthedeviceisusedexceedstheapplicableRFcompliancelevelabove,thedeviceshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingthedevice.

bOverthefrequencyrange150kHzto80MHz,fieldstrengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the device

Thedeviceisintendedforuseinanelectromagneticenvironmentinwhichradi-atedRFdisturbancesarecontrolled.Thecustomerortheuserofthedevicecanhelppreventelectromagnetic interferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andthedeviceasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.

Ratedmaximumoutput power oftransmitter

W

Separationdistanceaccording tofrequencyoftransmitter

m150kHzto80MHzd=1.2

8 0 M H z t o 8 0 0 MHzd=1.2

8 0 0 M H z to 2 . 5 GHzd=2.3

0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.3

10 3.8 3.8 7.3100 12 12 23

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecom-mendedseparationdistancedinmetres(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,whereP is the maximum output powerratingofthetransmitterinwatts(W)accordingtothetransmittermanu-facturer.

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NOTE1:At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrange applies. NOTE2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropaga-tionisaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.

MedimagingIntegratedSolutionInc.1F,No.7,R&DRdII,HsinchuSciencePark,Hsinchu,TAIWAN30076,R.O.C

Obelis S.A.Bd.GeneralWahis53,1030,Brussels,BelgiumIssueddate:July23,2014

Please visit www.miis.com.twformoreinformation.