MobileODT EVA System - Important Notes on Safety; List of Warnings

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EVASystemUserManual
No.10LB038
Rev.04
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Page11of86
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Keepawayfromsunlight
IPXY
IP(InternationalProtection)
code
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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.
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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.
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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.
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1.7. ListofWarnings
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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.
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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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