MobileODT EVA System - Indications for Use; Contraindications; Risks and Benefits; How to Read These Operating Instructions



EVASystemUserManual
No.10LB038
Rev.04
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Page10of86
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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