MobileODT EVA System User manual


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EVASystemUserManualNo.10LB038
Rev.04
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EVASystemUserManual
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RevisionHistory
Rev.
no.
ECO/
CAPA/
SWC
ChangeDescriptionDate
01CAPA20005
ECO334,
ECO335,
SWC336
Unifythefollowingusermanualsintoonedocument:AUM001
(Becomesobsolete),PUM001(Becomesobsolete),10LB004
(becomescontrolledreferencedocument).
UpdatetofeaturesaccordingtoECO’s/SWC’s.
AddVisualCheck
26/Nov/2020
02NAUpdateUserGuideName,rephrasesection1intro(General)10/Jan/2021
03 



Followingsectionswereupdated:
UpdateVisualCheckflow–section15.5
HandwavesettingsscreenshotsSection11.21
“About”section(replaced“Settings”)–Sections11.20,11.4.6,
11.7.4
HighcontrastfilteronportalSection10.9.10
Searchbaronapp–Sections11.19
QualityframescreenshotSection11.25
24/Jan/2021
04SWC338AddSANEBluetoothfootpedalsection13.3.3
Limitedcaptureimagesfordemoaccount–section11.9.11
Limitationofactivelogins11.4,10.6
reCaptchasection10.5,11.3

22/Feb/2021
05SWC339+3
40
6digitPINcodepolicy–Updatedsectionsandscreenshots11.1.8,
11.1.10,11.5,11.6.1
Reenterpasswordscreenshot10.4
Changesigninscreens–11.7.3,11.1.5,11.1..6
Updatedscreenshot–10.8.1
Change“Signin”to“Login”+screenshots–11.2,11.7.1,10.1,
10.3
Addedmessageonsigninscreens–updatedscreenshots11.7.3
Strongerpasswordpolicy–11.7.4,10.2.8,10.4.4

22/Apr/2021
RollingStandUpdatedsection2.1.1.5  08/Aug/2021
Hardware
section
Figuresnumberingorganizing–sections2.1.3,2.2,3.1,4.1,4.2,
4.3,7.2.2,7.3.2,7.4.2
13/Oct/2021



ApprovalMatrix
NamePositionSignatureDate
Doc ID: 4baaf484d7f5f01d2b8e5dc0fedc637256236abe

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EVASystemUserManualNo.10LB038
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WrittenbyAlmogAviviProductManager 
13/Oct/2021
ReviewedbyYanaKatsmanQA/RAManager 
13/Oct/2021
Reviewedby LiorShwarzwald HeadofProduct
13/Oct/2021
ApprovedbyLeonBoston CEO 
13/Oct/2021

 
Doc ID: 4baaf484d7f5f01d2b8e5dc0fedc637256236abe


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EVASystemUserManualNo.10LB038
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EVA(EnhancedVisualAssessment)System
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UserManual
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Doc ID: 4baaf484d7f5f01d2b8e5dc0fedc637256236abe


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EVASystemUserManualNo.10LB038
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TableofContents
Hardware..........................................................................................................................................................................8
1.General......................................................................................................................................................................9
1.1.IndicationsforUse..........................................................................................................................................10
1.2.Contraindications............................................................................................................................................10
1.3.RisksandBenefits...........................................................................................................................................10
1.4.HowtoReadTheseOperatingInstructions....................................................................................................10
1.5.SymbolsandMarkings....................................................................................................................................10
1.6.ImportantNotesonSafety..............................................................................................................................11
1.7.ListofWarnings...............................................................................................................................................11
1.8.ListofPrecautions...........................................................................................................................................12
1.9.ProductOverview............................................................................................................................................12
1.10.Components................................................................................................................................................12
1.11.PrimaryFunction.........................................................................................................................................13
2.EVASystemdevice..................................................................................................................................................14
2.1.ConnectingtotheEVAstandoraneckstrap.................................................................................................16
2.2.TurningontheLEDlight..................................................................................................................................19
3.Charging..................................................................................................................................................................20
3.1.ChargingtheOpticalUnit................................................................................................................................20
3.2.ChargingtheMobileDevice............................................................................................................................21
4.TakingtheMobileDeviceoutoftheOpticalUnit..................................................................................................22
4.1.Toremovethemobiledevicefromtheopticalunit(figure17):....................................................................22
4.2.Toinsertthemobiledeviceintotheopticalunit(figure18):.........................................................................22
4.3.OPTIONAL:TosecurethephoneintotheEVASystemdevice,preventingusersfromremovingthephone
fromtheopticaldevice(figure19):............................................................................................................................22
5.CareandMaintenance............................................................................................................................................24
5.1.Storage............................................................................................................................................................24
5.2.LensCare.........................................................................................................................................................24
5.3.Body/Base.......................................................................................................................................................24
5.4.CleaningInstructions.......................................................................................................................................24
6.Troubleshooting&Support....................................................................................................................................25
6.1.MobileUnitTroubleshooting..........................................................................................................................25
6.2.LensTroubleshooting......................................................................................................................................25
6.3.MobileDeviceTroubleshooting......................................................................................................................26
6.4.EVAApplicationTroubleshooting...................................................................................................................26
7.HowtoCaptureaClinicallyUsefulImage...............................................................................................................27
7.1.Stability...........................................................................................................................................................27
Doc ID: 4baaf484d7f5f01d2b8e5dc0fedc637256236abe

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7.2.Positioning.......................................................................................................................................................27
7.3.Illumination.....................................................................................................................................................28
7.4.Focus...............................................................................................................................................................28
8.Specifications..........................................................................................................................................................30
8.1.Electromagneticcompatibilitymanufacturerdeclaration............................................................................31
8.2.Electromagneticemissions.............................................................................................................................31
8.3.Recommendedseparationdistances..............................................................................................................33
9.Replacementpartsandtechnicalservice...............................................................................................................35
Software..........................................................................................................................................................................35
10.EVAPortal...........................................................................................................................................................36
10.1.Welcomescreen..........................................................................................................................................36
10.2.Settingupauser.........................................................................................................................................36
10.3.Signingin.....................................................................................................................................................37
10.4.Forgotpassword.........................................................................................................................................38
10.5.Viewingpatientrecords..............................................................................................................................39
10.6.Searchingforpatientrecords......................................................................................................................40
10.7.Reviewingandeditingpatientexaminationrecords..................................................................................40
10.8.EditingtheExam.........................................................................................................................................40
10.9.Viewingimagesandannotations................................................................................................................41
10.10.Addingnotes...............................................................................................................................................43
10.11.Help.............................................................................................................................................................43
10.12.Export&Download.....................................................................................................................................44
11.EVASystemsoftwareapplication.......................................................................................................................47
11.1.SettingUpaNewUser................................................................................................................................47
11.2.Login(existinguser)...................................................................................................................................50
11.3.ResetPIN.....................................................................................................................................................50
11.4.Changingtheuser.......................................................................................................................................51
11.5.ResetEVAaccountpassword......................................................................................................................52
11.6.Optoutstatus.............................................................................................................................................53
11.7.NotificationCenter......................................................................................................................................54
11.8.Performinganexam....................................................................................................................................55
11.9.Captureimages...........................................................................................................................................57
11.10.Changingsettingsduringanexam(Cameramenu)....................................................................................59
11.11.Reviewmediafiles......................................................................................................................................60
11.12.Addannotations..........................................................................................................................................60
11.13.Summary.....................................................................................................................................................62
Doc ID: 4baaf484d7f5f01d2b8e5dc0fedc637256236abe

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11.14.Exportingtheexam.....................................................................................................................................62
11.15.Backupexamsonalocaldrive:..................................................................................................................64
11.16.Limitedstoragepreventingexport.............................................................................................................65
11.17.Reviewingexamsontheapp......................................................................................................................65
11.18.Deletinganexam........................................................................................................................................68
11.19.ExamDrafts.................................................................................................................................................69
11.20.About...........................................................................................................................................................69
11.21.Handwavefeature.......................................................................................................................................70
11.22.Cameramode..............................................................................................................................................70
11.23.Qualityframe..............................................................................................................................................70
11.24.Support........................................................................................................................................................71
11.25.Learn............................................................................................................................................................71
11.26.Logout........................................................................................................................................................71
Appendices......................................................................................................................................................................72
12.Appendix1:EVACOLPO......................................................................................................................................73
12.1.Addhistoryofpresentillness......................................................................................................................73
12.2.Colposcopicimpression..............................................................................................................................73
12.3.Optionalfeatures........................................................................................................................................74
13.Appendix2:EVASANE........................................................................................................................................75
13.1.Addadditionaldetails.................................................................................................................................75
13.2.Addclinicalimpression...............................................................................................................................75
13.3.Additionalfeatures......................................................................................................................................76
14.Appendix3:EVAVIA...........................................................................................................................................78
14.1.Addadditionaldetails.................................................................................................................................78
14.2.Addclinicalimpression...............................................................................................................................79
14.3.Optionalfeatures........................................................................................................................................79
15.Appendix4:VisualCheck.....................................................................................................................................80
15.1.Intendeduse...............................................................................................................................................80
15.2.Targetpopulation........................................................................................................................................80
15.3.WarningsandPrecautions..........................................................................................................................80
15.4.PerformingVisualCheckassessment..........................................................................................................81
15.5.RunningtheVisualCheckanalysisfromtheEVAdevice.............................................................................81
15.6.RunningVisualCheckanalysisfromtheEVAPortal....................................................................................82
15.7.VisualCheckresults.....................................................................................................................................83
16.Appendix5:Qualityframe..................................................................................................................................85
16.1.UsingtheQualityframe..............................................................................................................................85
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17.Appendix6:Teleconsultation(ZoomTelehealth)...............................................................................................86
17.1.InstallingtheZoomApplication..................................................................................................................86
17.2.Initiatingateleconsultationconnection.....................................................................................................86
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1. General
ThankyouforpurchasingtheEVASystembyMobileODT.Pleasereadtheinstructionscontainedinthis
userguidethoroughlybeforeusingyournewvisualizationsolution.Thisuserguidecanbefoundonlineat
help.mobileodt.com.

Thisuserguidewillhelpallusersincludingthoseutilizingoneofourclinicalscenarios(pleaseseeappendicesCOPLO,
SANEandVIA)andonallofourdevicemodelsincluding:
EVA3Plus,EVAWELLandEVA3.0*.

*ForthoseusersonEVA3.0pleasecontactsupportforadditionalinformationonhardwaremaintenanceand
support)

Forfurthersupport,pleasecontactus:

MobileODT,LTD.
BenAvigdor8,
TelAviv,Israel6721832
Email: supp[email protected]om
Tel.:+1(617)4544687
  Website:www.mobileodt.com
ThefollowingisthecontactinformationfortheEuropeanAuthorizedRepresentativeusedforthisdevice:



FULLTRAININGFORUSEOFTHEEVASYSTEM
CANBEFOUNDAT:

HTTP://LEARN.MOBILEODT.COM
HTTP://HELP.MOBILEODT.COM

 
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1.1. IndicationsforUse
TheEVASystemisintendedtoprovidemagnifiedviewingofthevagina,cervix,andexternalgenitaliainorder
toaidindiagnosingabnormalitiesandselectingareasforbiopsy.Thesolutionisintendedforuseinhospitals,
doctors’offices,andremoteandruralclinics.
1.2. Contraindications
TherearenocontraindicationsforuseoftheEVASystem.
1.3. RisksandBenefits
TheEVASystemshouldnottouchthepatient.Thereareminimalriskstothepatient.Thesystemhasbeen
testedaccordingtospecificmedicalstandards.
1.4. HowtoReadTheseOperatingInstructions
TheseinstructionsarestructuredaroundtheoperationoftheEVASystem,fromassemblytoclinicaluse.
Basictroubleshootinginformationisalsoprovided.
ThefollowingcontentcontainsinstructionsfortheassemblyanduseoftheEVASystemcolposcope.
Instructionsfortheintegratedmobileapplicationandcloudconnectedonlineportalarereferencedinthe
manual.
1.5. SymbolsandMarkings
Generalwarningsign
Standbysymbol

PressthisbuttontoturnontheLEDlight.Pressthebuttonasecondtimetoturnitoff.
Symbol
Description

SerialNumber

CatalogNumber

Refertoinstruction
manual/booklet

Prescriptionuseonly
CEMark

WasteofElectricaland
ElectronicEquipment(WEEE)
compliancesymbol
Manufacturer
DateofManufacture

AuthorizedRepresentativeinthe
EuropeanUnion


DC(Battery)
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Keepawayfromsunlight
IPXYIP(InternationalProtection)
code


IntheUnitedStates,federallawrestrictsprescriptionmedicaldevicestobesoldbyorontheorderofa
physicianorproperlylicensedpractitioner.

1.6. ImportantNotesonSafety
BeforeyoubeginusingtheEVASystem,pleasebecomefamiliarwiththefollowingsafetyregulationsand
keeptheseinmindwhileusingthedevice.

UsersoftheEVASystemshouldbethoroughlytrainedintheappropriatemedicalprocedures.Allusersneed
toreadandunderstandtheseinstructionsbeforeperforminganyprocedure.

1.7. ListofWarnings

Thewarningstatementsinthismanualdescribeseriousadversereactionsandpotentialsafetyhazards,
limitationsinuseimposedbythem,andstepsthatshouldbetakeniftheydooccur.

1.7.1. Localand/orotherapplicablelawsmayrestrictthesaleofthisdeviceto,ortotheorderof,aphysician
orotherappropriatelylicensedmedicalprofessional.TheEVASystemmaynotbeusedunlessyouor
yourorganizationmeettherequirementsand/orobligationsundersuchlawsandyouassumefull
responsibilityforanyillegalpurchaseand/oruseofthedevice.TheEVASystemshouldonlybeused
byatrainedandlicensedoperator,whoseaccreditationisvalidinthecountryand/orregioninwhich
theproceduresarebeingconducted.
1.7.2. AllservicetotheEVASystemmustbeperformedbyMobileODToranauthorizedrepaircenter.
Therearenouserserviceablepartsinthisunitorinitsaccessories(otherthanthemobiledevice).
Anyattempttodisassembleand/orrepairthisunitwillresultinvoidingofthewarranty.
1.7.3. CaptureimagesonlywithintheEVAapplication.
1.7.4. Theattachedlensshouldnotberemovedfromtheunititwassentwith,withoutwrittenapproval
fromthemanufacturer.
1.7.5. TheLEDlightisextremelybrightandshouldbetheonlyilluminationusedasalightsourceduringan
examination.Donotstaredirectlyintothelightwhenitisinoperation.
1.7.6. Thesystem,bothopticalunitandmobiledevice,shouldnotbeusedwhilebeingcharged.Usersare
requestedtotakecaretochargethesystembeforeuse.
1.7.7. Onlythededicatedmobiledevicethatcomeswiththisopticalunitandcomplieswithrelevantsafety
standardscanbeusedwiththeEVASystem.
1.7.8. WhentransmittingdatafromtheEVAapplicationoveraWiFinetwork,onlyuseapassword
protectedconnection(WPA2,notWPAorWEP).
1.7.9. Inenvironmentswheremobiledevicesarerestricted,theEVASystemcanbeusedinairplanemode.
Wherevermobiledevicesarepermittedforuse,theEVASystemcanbeusedinitsonlineconnected
mode.
1.7.10. Thisdevicecontainslithiumbatteries.Abatteryreplacementbyinadequatelytrainedpersonnelcould
resultinahazard(suchasexcessivetemperatures,fireorexplosion),andthereforeshouldbesent
backtoMobileODTforservice.
1.7.11. TheEVASystemshouldbechargedusingastandardmicroUSBchargerformobiledevicecharging.A
singleordualportUSBchargermaybeused,butitisrecommendedtousethechargerprovidedwith
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thesystemforoptimalresults.Specifically,a5VDCwithacurrentcapacityof2A,regardlessofthe
powersupplyinput.

1.8. ListofPrecautions
Precautionsinthismanualregardthespecialcareexercisedbythepractitionerforthesafeandeffectiveuse
ofthecolposcope.
1.8.1. Donotallowthecolposcopetocomeincontactwiththepatient.
1.8.2. DonottouchtheopticallensorLEDlightexceptasdescribedinthemaintenancesectionofthis
manual.
1.8.3. Donotimmerseanypartofthecolposcopeincleaningsolutionsoranyfluid.
1.8.4. Donotusestrongdetergentsoralcoholunderanycircumstancesforopticscleaning.Thiswouldleadto
irrevocabledamagetotheopticallycoatedlenssurfaces.
1.8.5. Tolimitcontamination,userecommendeddisinfectantagentsbetweeneachexam.
1.8.6. Donotusecorrosivematerialsorstrongcleaningmaterialsotherthanthosespecificallyprescribedon
thecasingsorontheoptics.Suchmaterialsleadtopermanentdamageofthepaintedsurfaceofyour
colposcopeand/orscratchthelenscoatingsoftheoptics.Thisleadstoconsiderablelossofqualityof
theentirevisualsystem.
1.8.7. TheEVASystemwasbuilttoberesilient,butneedstobetakencareoflikeanyotherelectronic
device.Itshouldneverbestoredoroperatedinareaswhereitcouldgetwetorcouldbeexposedto
environmentalconditionssuchasextremetemperatureorhumidity,prolongeddirectsunlight,dust,
etc.
1.8.8. IftheLEDlightceasestowork,duetobatterydrainorLEDburnout,stopusingthecolposcopeand
rechargethebatteries.SometimesadischargedbatterywillmanifestviaaflickeringLED.Inthiscase,
rechargethebatterytofullcapacitybeforecontinuinguse.
1.8.9. Nomodificationofthisequipmentisrecommended.

1.9. ProductOverview
Beforeuseofyourcolposcope,checkfordamageontheoutsideofthetransportpackaging,theopticalunit,
mobiledevice,andanyaccessories.

Thefollowingchaptersprovidestepbystepinstructionsforthetesting,installation,operation,andsecurity
references.
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1.10. Components
BeforeinitialsetupoftheEVASystem,checkthatyouhavereceivedallthefollowingcomponents:
•Opticalunitbodyandlens
•SamsungJ530mobiledevice*
•Syncwire2Ports30W/6ADualPortMicroUSBCharger
•Sparepartskitincluding:1chargingcable,2technicianscrewsandanAllenkey
•Neckstrap
•Lenscleaningcloth
•Userguide

Ifanypartsaremissing,pleasenotifyMobileODT.

*PleaserefertotheSamsungJ530usermanualtofindspecificationsregardingtheWiFi,howthemobile
deviceshouldbeconfiguredandoperatedincludingthequalityofservice,operatingdistancesandranges,
securityrequirements,andhowtodealwithanyrisksandproblemsthatmayarise.

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1.11. PrimaryFunction
Toavoiddoubt,theprimaryfunctionoftheEVASystemisformobilecolposcopy,themagnifiedviewingof
thetissuesofthevagina,cervix,andexternalgenitaliaforthepurposeofconductingcolposcopy.Useofthe
colposcopeanditsprimaryfunctionofvisualizationisnotdependentuponconstantWiFiormobile
connection.IfinterferencefromotherWiFidevicesaffectstheWiFiconnectionoriftheWiFiconnectionis
interruptedorlostduetoanyotherreason,thecolposcopecanstillfunctionasintendedandimageswillbe
syncedandaccessibleontheonlineportalwhenaconnectionisrestored.
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2. EVASystemdevice
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BackView(figure1)
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 
FrontView(figure2)
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LeftView(figure3)    Rightview(figure4)
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2.1. ConnectingtotheEVAstandoraneckstrap
TogetherwithyourEVASystem,MobileODTprovidesadevicestandforstabilizingthecolposcopewhile
capturinganimage.Therearetwotypesofstands:awheeledstandandaportablestand.Belowarebasic
instructionsonconnectingthecolposcopetobothmodels.Seethedetailedassemblyinstructionsthatcame
withthestanditselfforfurtherexplanations.
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2.1.1. WheeledStand
2.1.1.1. Thewheeledstandenableshandsfreeexaminationandallowsyoutomovefreelywithinyour
clinicwhilekeeping theEVASystem connected tothestandatalltimes.
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2.1.1.2. Thewheeledstandarrivesintwodistinctparts:thebaseandthepole.Duringtheexam,thestand
wheelsshouldbelockedmanuallytoimprovestabilityandlimitmotionblur.
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2.1.1.3. Inaddition,the360°ballheadcanbeadjustedduringtheexampletoimprovetheabilityto
visualizethecervixatthenecessaryangle.
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2.1.1.4. Toassemblethestand,usetheprovidedkeytoscrewthepipewiththeballheadtothebasewith
helpofM6selflockingnut,M6washerandspringwasherincludedintheshipment.Refertothe
graphicalinstructionsbelow.
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2.1.1.5. Therearetwostandmodelsthatareassembledaccordingtotheassemblyinstructionsthatare
providedwiththestand.Thestandmodelisprovidedaccordingtostockavailable.
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2.1.1.5.1. A3legsstand:
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2.1.1.5.2. A4legsstand:
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2.1.2. PortableStand
Theportablestandalsoenablesahandsfreeexamination.Thisstandcanbecarriedfromlocationto
location,canbefoldedforportabilitybetweenexamrooms,orputintotheaccompaniedcarryingcaseto
movebetweenclinicalsites.
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2.1.3. ConnectingtheNeckStrap
Thecolposcopecanbeconnectedtoaneckstrapforcarryingtheunitmorecomfortablyaroundyourclinic.
Pleasefollowthestepsbelowtoconnecttheneckstraptothecolposcopesecurely:
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2.1.3.1. Toattachthestraptothedevice,firstflattenthestrapandslideitunderonecornerofthestrap
attachmentslot.
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Doc ID: 4baaf484d7f5f01d2b8e5dc0fedc637256236abe


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EVASystemUserManualNo.10LB038
Rev.04
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Page19of86
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(figure5)    (figure6)
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2.1.3.2. Slidethestrapunderthesecondcornerandpullthrough.
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(figure7)    (figure8)
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2.2. TurningontheLEDlight
TurnontheLEDlightbypressingtheon/offbutton.
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(figure9)(figure10)
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Doc ID: 4baaf484d7f5f01d2b8e5dc0fedc637256236abe


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EVASystemUserManualNo.10LB038
Rev.04
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Page20of86
3. Charging
TheEVASystemincludestwocomponents:theopticalunitandmobiledevice.Eachneedstobecharged
separately.
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2Ports30W/6A
Achargerappropriateforover150countriesisprovided,inordertoallowforchargingindifferentcountries.
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Power:30W
Input:100240V
Output:3A*2
Technology:iSmart
Weight:100g
Dimensions:50mm*43mm*42mm
Certification:CE/FCC/UL/LVD
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3.1. ChargingtheOpticalUnit
3.1.1. Tochargetheopticalunit,connecttheMicroUSBchargertotheunit’srightsidechargingport.Connect
thecabletoawallsocketwiththeproperUSBelectricalportadapter.
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(figure11)
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3.1.2. ThechargerincludedhastwoslotsforUSBstoallowcharginginasingleelectricaloutlet.
3.1.3. TheChargeIndicatorLightscanbefoundabovethechargingportonthefrontoftheopticalunit.When
connectedtothecharger,thelightswillturnonandturngreenwhilecharging.
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PleaseNote:Thecolposcopecannotbeusedwhilecharging,astheLEDlightwillnotbeabletobeswitched
on.
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3.1.4. Chargeindicatorlights–operationmode
Doc ID: 4baaf484d7f5f01d2b8e5dc0fedc637256236abe