MiiS Horus+ EOC 100 User manual

Horus+Scope
EOC 100 Digital Otoscope
User Manual
DOC. No. 2014.02-A
Copyright@2014 MiiS Inc.
All right reserved.

1. Category 1
2. Symbols 2
3. Warnings and Cautions 3
4. Intended for Use 8
5. User Interface 9
6. Operating Instructions 11
7. Battery Charging and Photo
Transferring 12
8. Battery Replacement 13
9. Cleaning and Disinfection 14
10. Operation Environment 15
11. Environment for Storage and
Transportation 15
12. Technical Description 16
13. Liability 17
14. Environment 18
15. Standards 19

1
1. Category
Model Name MiiS Horus+ Scope EOC 100
Product Name Digital Otoscope
Accessory 1.Baery
2. Disposable Specula
a.) adult x 8
b.) pediatric x 8
3. Power Adapter
4. USB Cable
5. AV Cable

2 3
2. Symbols
Cauonmustbetaken.Readuser’smanualbeforeuse.
TypeBF-Indicatesthedeviceisclassifiedasadevice
with a Type BF applied part.
Theoperatorisadvisedtoreadtheinstructionsof
user’smanual.
Manufacturer.
DateofManufacture.
CEmark.
EuropeanAuthorizedRepresentave.
This product is a rechargeable internal Class II power
supply.
3. Warnings and Cautions
NOTE
Priortoinstallationandstart-upofthedevice,carefullyreadthe
instruconsprovidedherein!Aswithalltechnicaldevices,theproper
functionandsafetyoperationofthis devicedependontheuser’s
compliancewiththesafetyrecommendaonswhicharepresentedin
theseoperanginstrucons.Donotaempttoopenthecoverofthe
product,soastoavoidmalfunconofproduct.
CAUTION
Alwaysuse the deviceinaccordancewiththedirecons
andrecommendaonscontainedinthisUserManual.
Operatethedevice,pleasetakenotethatopticallens
donottouchtheeyesornoseofpaent.Avoidharmto
paent.
Topreventreorelectricalshock,donotexposethese
appliances to rain or moisture.
Thisdeviceisnotwaterproof.Iftheopticallensand
controlunitgetwet;donotaempttodrywithaheater,
microwave,autoclaveorUVlight.

4 5
Avoidsubjecngthedevicetovibraonorshock.When
theproductisnotinuse,please disconnectthepower
plugandkeepitinasafeplace.
Avoidusingthedeviceinadustyenvironment,andkeep
thepowercordawayfromanyheatsource.
Beforeoperaon,pleasemakesuretheappearanceisnot
damagedorbroken.Iftherearebreaksinthedevicecov-
erorothervisualdefects,pleasecontactmanufactureror
manufacturerceredservicefacility.
Pleasedonotchargethebaerywhenthedeviceisoper-
ated by the user.
OnlyuseLi-ionBaery3.7V@2600mAhwhichshallbe
providedbythemanufacturerordistributors.Thebaery
hasdesignedtheproteconcircuit.Toensurethesafety
oftheproductoperaon,ifthebaeryreacheslifeme
orfailure,pleasecontactthemanufacturerordistributor
tobuythesparebaery.
IfyoupurchasedifferentmemorycapacityofMicroSD
Card,mustbeprecededformattoFAT32.
Theeyecan’tbe exposedtotheilluminaonlightofthe
productatoperaon.
ReplacethedisposablespeculaofHorus+ScopeEOC100,
DigitalOtoscope,beforeeachuseforanewpaent.
GentlyinsertthespeculaofHorus+ScopeEOC100into
earcanal.Tokeepasafetydistancebetweenthespecula
andtympanicmembrane.Donotmakethespeculacon-
tactwithear’stympanicmembrane.
Nomodificationofthisdeviceisallowed.Theperfor-
mancewouldbechangedifmodifythisdevicebyuser.
Modicaontothisdevicemaycausehazardousradiaon
exposure.
Thisdevicehasbeentestedandfoundtocomplywiththe
limitsformedicaldevicestotheIEC60601-1-2:2007.
These limits are designed to provide reasonable protec-
onagainstharmfulinterferenceinastandardmedical
installaon.Ifthisdevicedoescauseharmfulinterference
tootherdevices,whichcanbedeterminedbyturning
thesystemoandon,theuserisencouragedtotryto
correcttheinterferencebyoneormoreof thefollowing
measures:
• Reorientorrelocatethereceivingdevice
• Increasetheseparaonbetweenthe systemand
other devices.
• Connectthedevicetoan outletonacircuitdif-
ferentfromthattowhichtheotherdevice(s)are
connected.

6 7
• Consultthemanufactureroreldservicetechni-
cianforhelp.
The International Electrotechnical Commission sets the
essentialrequirementsforelectricalandelectronic
equipmentthatmaydisturb,orbedisturbedby,other
equipment.
The device complies with these requirements as shown
inthetablesin“15.(1)EMC(ElectromagnecCompabil-
ity)”(Page13-16).Followtheguidanceinthetablesfor
useofthedeviceinanelectromagnecenvironment.
Duringinstallaonand operaonofthedevice,observe
thefollowinginstructionsaboutEMC(electromagnetic
compability):
• Do not use the device simultaneously with other
electronic equipment to avoid
• electromagnecinterferencewiththeoperaonof
the device.
• Donotuseorstackthedevicenear,on,orunder
other electronic equipment to avoid electromag-
necinterferencewiththeoperaonofthedevice.
• Do not use the device in the same room as other
electronicequipmentsuchaslife-support equip-
ment,equipmentthathasmajoreffectsonthe
lifeofthepaentandresultsoftreatment,orany
other measurement or treatment equipment that
involves small electric current.
• Do not use the system with portable and mobile
radiofrequencycommunicaonsystemsbecause
thatmayhaveanadverseeectonoperaonof
the device.
• Do not use cables or accessories that are not
speciedforthedevicebecausethatmayincrease
theemissionofelectromagneticwavesfromthe
deviceanddecreasetheimmunityofthedeviceto
electromagnecdisturbance.
• Donottouchlensconnecngpins ofcontrolunit,
orsignalpadoflenseswithoutspecialprecauons.
Usersareresponsibleformanagingcapturedimagedata.
Manufacturerwillnotassumeanyresponsibilityforloss
ofdata.

8 9
4. Intended for Use
EOC 100 is a digital hand-held otoscope used to record digital photo-
graphsandvideoofthehumanear’scanalandtympanicmembrane.
EOC100canalsobe usedatgeneralInspeconofthroatandnasal
cavity and capture the photographs and video.
5. User Interface
Powerbuon
Interfaceof
specula
Focus wheel
Baerycover
Insuaonport

10 11
6. Operating Instructions
SD Card slot
AV out
Mini USB out
Attaching / removing
direconofthespecula
13:24:122014/04/16
5B 1234M
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1.OperaonMode:
Photo
Video
Display
2. Brightness indicator
3. Free memory
ofSDCard
4. Power indicator
5. Date indicator
6.Timeindicator
7.Brightnessdecreasing/
Funconselecon
8. MENU
9. Brightness increasing/
Funconselecon
10.StatusIndicator:
BlueLED-NormalOperaon
Orange LED- In charging
11.CaptureBuon

12 13
7. Battery Charging and Photo
Transferring
Baery Charging:
Step1. Connect the EOC 100 and power adapter via USB cable.
Step2. Insertthepoweradapterintothewallplugforcharging.
Photo Transferring:
Connect the EOC 100 and computer via USB cable. At normal situa-
on,EOC100becomesastandardstoragedevice,usercanreviewor
copythephotosfromthisdevicetothecomputer.
NOTE
EOC 100 can also operate at “UVC” mode. It means the pictures can
beshownatLCDpanelofEOC100andthescreenofthecomputerif
EOC 100 is connected to computer via USB cable.
Userwanttooperateat“UVC”mode,pleaseenterthemenutoen-
ablethisfuncon.
8. Battery Replacement
BaeryReplacement
Openthebaerycoverbydiggingoutthegapintheboomofbat-
terycoverwithangerorsomethingpointed.
• Tiltthebaerycoverandremovethebaerycoverbyliingit
up.
• Removethe originalbaeryandreplaceanewbaeryalong
thecorrectdirecon.
• Placethebaerycoverandsecureitinplace.

14 15
9. Cleaning and Disinfection
The device is a precision photoelectronic instrument that shall be
handledwithspecificcare.Pleasenotefollowingcleaninginstruc-
ons:
• Powerodevicebeforecleaningit.
• Disinfecttheproductwiththesoftclothwithalcohol(70%
ethyl alcohol).
• Itisrecommendedtocleantheopcallenswithcleaningcloth
orlenscleaningssuesuchasTHORLABInc.,(www.thorlabs.
com) Lens Cleaning Tissue.
Ifthereplacementfornewdisposablespecula,pleasecontactwith
manufactureroryourownretailer.
NOTE
The device is not intended to be sterilized
10. Operation Environment
• Ambienttemperature: 0°Cto+35°C
• Relavehumidity:  10%to80%
• Atmosphericpressure: 700hPa~1060hPa
11. Environment for Storage and
Transportation
• Ambienttemperature: -10°Cto+40°C
• Relavehumidityrange: 10%to95%
NOTE
Itisrecommendedtoremovethebaeryifthedeviceisstoredover2
weeks.

16 17
12. Technical Description
• FocusRange 25~100mm(Typical)
• Dimension 180x70x70mm3(Typical)
• Weight 200Grams(Typical)
• Camera/Video NaturalWhiteLightEmingDiode(LED)
Focus: Manual Focus
CameraResoluon: 1920 x 1080 pixels
Screen: TFT-LCD
ImageFormat: JPEG(Photograph)and
H.264(Video)
Interface: MiniUSB,AVoutport
FileTransfer: Mini USB Port to PC
DynamicVideoOutput: CompositeAVout,orUSB
livevideoenablefromUSB
port
Filestorage: SDCard,default8GB.Sup-
ports 2G to 32GB by FAT32
Format
PowerSource: RechargeableLithiumBat-
tery3.7V/2600mAh
ExternalPower: Source: 100~240VAC,
50/60Hz
Poweradapteroutputspec: 5VDC,1.2A
Operangme: 3hoursat2.5Wattcondi-
on
Chargingme: 5 hours
Expectedservicelife:
(denedbymanufacturer)
5yearsfromthedateof
inialoperaon
*Proper maintenance is
necessary
13. Liability
Manufacturerconsidersitselfresponsiblefortheeffectsonsafety,
reliabilityandperformanceofthedeviceonlyif:
• Assemblyoperations,extensions,re-adjustments,modifica-
onsorrepairsarecarriedoutbypersonsauthorized.
• Theelectricalinstallaonof the relevantroomcomplieswith
the requirements.
• Theequipmentisusedinaccordancewiththeseinstrucons
foruse.

18 19
14. Environment
• Follow the local governing ordinances and recycling plans re-
gardingdisposalorrecyclingofdevicecomponents.Especially
whendisposingofthelithiumionbaery,circuitboard,plasc
partsthatcontainbrominatedameretardant,LCD,orpower
cord,besuretofollowthelocalgoverningordinances.
• Follow the local governing ordinances and recycling plans
whendisposingofthecircuitboardwiththelithiumbaery.
Inappropriate disposal may contaminate the environment.
• Whendisposingofpackingmaterials,sortthembymaterial
andfollowlocalordinancesandrecyclingregulaons.
• Inappropriate disposal may contaminate the environment.
• Whendisposingofeyecup,followthedisposalproceduresfor
medicalwastesuchasneedles,infusiontubes,metalinstru-
mentsforsurgeryasspeciedbyyourmedicalfacilitytoavoid
infeconoutsidethefacilityandenvironmentalpolluon.
15. Standards
Electricalsafety IEC60601-1:2005
(EN60601-1:2006)
EMC and regulatory
compliance
IEC60601-1-2:2007
(EN60601-1-2:2007)
• Equipmentconnectedtotheanalogordigitalinterfacesmust
becertifiedaccordingtotherepresentativeappropriate
nationalstandards(suchasEN60601-1andIEC60601-1).
Furthermore,allconguraonsshallcomplywiththesystem
standardIEC60601-1.Anyonewhoconnectsaddionalequip-
menttothesignalinputpartorsignal output partcongures
amedicalsystem,andisthereforeresponsiblethatthesystem
complieswiththerequirementsofthesystemstandardIEC
60601-1.Ifindoubt,consultthetechnicalservicedepartment
ofyourlocalrepresentave.
EMC (Electromagnec Compability)
ThedevicecomplieswiththeInternaonalElectrotechnicalCommis-
sionstandards(IEC6060112:2007)forelectromagneccompability
aslistedinthetablesbelow.Followtheguidanceinthetablesforuse
ofthedeviceinanelectromagnecenvironment.

20 21
EMC (IEC 60601 1 2: 2007)
Guidance and manufacturer’s declara-
on electromagnec emissions
Thedeviceisintendedforuseintheelectromagnecenviron-
mentspeciedbelow.Thecustomerortheuserofthedevice
should assure that it is used in such an environment.
Emissions test Compliance Electromagnecenvi-
ronment guidance
RFemissions
CISPR11
Group 1 Thedeviceuses RFenergyonly
foritsinternalfunction.There-
fore,itsRFemissionsareverylow
andarenot likelytocause any
interferenceinnearbyelectronic
equipment.
RFemissions
CISPR11
Class B Thedeviceissuitableforusein
allestablishments,includingdo-
mescestablishmentsandthose
directly connected to the public
lowvoltagepowersupplynetwork
thatsuppliesbuildings usedfor
domescpurposes.
Harmonic emissions
IEC6100032
*1
Voltageuctuaons/Flick-
eremissionsIEC6100033
*2
*1Fortheregionswheretheratedvoltageis220Vorgreater,thisdevicecomplies
withclassA.Fortheregionswheretheratedvoltageis127Vorless,thisstandard
is not applicable.
*2Fortheregionswheretheratedvoltageis220Vorgreater,thisdevicecomplies
withthisstandard.Fortheregionswheretheratedvoltageis127 Vorless,this
standard is not applicable.
Guidance and manufacturer’s declara-
on electromagnec immunity
Thedeviceisintendedforuseintheelectromagnecenviron-
mentspeciedbelow.Thecustomerortheuserofthedevice
should assure that it is used in such an environment.
Immunity test IEC60601
test level
Compli-
ance level
Electromag-
necenviron-
ment guidance
Electrostac
Discharge(ESD)
IEC6100042
±6kVcontact
±8kVair
±6kVcontact
±8kVair
Floor should be
wood,concrete
orceramicle.If
oorsarecovered
withsynthecma-
terial,therelave
humidity should
beatleast30%.
Electricalfast
transient/burst
IEC6100044
±2kV
forpower
supply lines
±1kV
forinput/
output lines
±2kV
forpower
supply lines
±1kV
forinput/
output lines
Mains power
quality should be
thatofatypical
commercial or hos-
pital environment.
Surge
IEC6100045
±1kV
dierenalmode
±2kV
common mode
±1kV
dierenalmode
±2kV
common mode
Mains power
quality should be
thatofatypical
commercial or hos-
pital environment.

22 23
Voltage,dips,short
interruponsand
voltagevariaons
on power supply
input lines
IEC61000411
<5%U
T
(>95%dipinU
T
)
for0.5cycle
40%U
T
(60%dipinU
T
)
for5cycles
70%U
T
(30%dipinU
T
)
for25cycles
<5%U
T
(>95%dipinU
T
)
for5sec
<5%U
T
(>95%dipinU
T
)
for0.5cycle
40%U
T
(60%dipinU
T
)
for5cycles
70%U
T
(30%dipinU
T
)
for25cycles
<5%U
T
(>95%dipinU
T
)
for5sec
Mains power qual-
ity should be that
ofatypicalcom-
mercial or hospital
environment.Ifthe
userofthedevice
requiresconnued
operaonduring
power mains
interrupons,itis
recommended that
the device be pow-
eredfromanunin-
terrupblepower
supplyorabaery.
Powerfrequency
(50/60Hz)mag-
neceld
IEC6100048
3 A/m 3 A/m Powerfrequency
magnecelds
should be at levels
characteriscof
atypicallocaon
in a typical com-
mercial or hospital
environment
NOTE:U
T
isthea.c.mainsvoltagepriortoapplicaonofthetestlevel.
Guidance and manufacturer’s declara-
on electromagnec immunity
Thedeviceisintendedforuseintheelectromagnecenviron-
mentspeciedbelow.Thecustomerortheuserofthedevice
should assure that it is used in such an environment.
Immu-
nity test
IEC60601
test level
Compli-
ance level
Electromagnecenviron-
ment guidance
Con-
ductedRF
IEC
6100046
RadiatedRF
IEC
6100043
3 Vrms
150kHzto
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 Vrms
(V1=3)
3 V/m
(E1=3)
PortableandmobileRFcommunicaons
equipment should be used no closer to
anypartofthedevice,includingcables,
thantherecommendedseparaondis-
tancecalculatedfromtheequaonappli-
cabletothefrequencyofthetransmier.
Recommended separaon distance
d=1.2  150kHzto80MHz
d=1.2 80 MHz to 800 MHz
d=2.3 800 MHz to 2.5 GHz
where Pis the maximum output
powerrangofthetransmierin
was(W)accordingtothetransmier
manufactureranddistherecommended
separaondistanceinmeters(m).
FieldstrengthsfromxedRFtransmiers,
asdeterminedbyanelectromagnecsite
survey,ashould be less than the compli-
ancelevelineachfrequencyrange.b

24 25
Interferencemayoccurinthe
vicinityofequipmentmarked
withthefollowingsymbol:
NOTE1:At80MHzand800MHz,thehigherfrequencyrangeapplies.
NOTE2:Theseguidelinesmaynotapplyinallsituaons.Electromagnecpropaga-
onisaectedbyabsorponandreeconfromstructures,objectsandpeople.
aFieldstrengthsfromxedtransmiers,suchasbasestaonsforradio
(cellular/cordless)telephonesandlandmobileradios,amateurradio,AM
andFMradiobroadcastandTVbroadcastcannotbepredictedtheorecally
withaccuracy.ToassesstheelectromagnecenvironmentduetoxedRF
transmiers,anelectromagnecsitesurveyshouldbeconsidered.Ifthe
measuredeldstrengthinthelocaoninwhichthedeviceisusedexceeds
theapplicableRFcompliancelevelabove,thedeviceshouldbeobservedto
verifynormaloperaon.Ifabnormalperformanceisobserved,addional
measuresmaybenecessary,suchasreorienngorrelocangthedevice.
bOverthefrequencyrange150kHzto80MHz,eld
strengths should be less than 3 V/m.
Recommended separaon distances between portable and
mobile RF communicaons equipment and the device
Thedeviceis intendedforuseinanelectromagnecenvironmentinwhichradi-
atedRFdisturbancesarecontrolled.Thecustomerortheuserofthedevicecan
helppreventelectromagnecinterferenceby maintainingaminimumdistance
betweenportableandmobileRFcommunicaonsequipment(transmiers)and
thedeviceasrecommendedbelow,accordingtothemaximumoutputpowerof
thecommunicaonsequipment.
Ratedmaximum
output power
oftransmier
W
Separaondistanceaccording
tofrequencyoftransmier
m
150kHzto80MHz
d=1.2
80 MHz to 800
MHz
d=1.2
800 MHz to 2.5
GHz
d=2.3
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
Fortransmiersratedatamaximumoutputpowernot listedabove,the recom-
mendedseparaondistancedinmetres(m)canbeesmatedusingtheequaon
applicabletothe frequencyofthetransmier,wherePis the maximum output
powerrangofthetransmierinwas(W)accordingtothe transmiermanu-
facturer.

26 27
NOTE1:At80MHzand800MHz,theseparaondistanceforthehigherfrequency
range applies.
NOTE2:Theseguidelinesmaynotapplyinallsituaons.Electromagnecpropaga-
onisaectedbyabsorponandreeconfromstructures,objectsandpeople.
MedimagingIntegratedSoluonInc.
1F,No.7,R&DRdII,HsinchuSciencePark,
Hsinchu,TAIWAN30076,R.O.C
Obelis S.A.
Bd.GeneralWahis53,1030,Brussels,Belgium
Issueddate:July23,2014
Please visit www.miis.com.twformoreinformaon.