MobileODT EVA System - Intended Use; Target Population; Warnings and Precautions


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EVASystemUserManual
No.10LB038
Rev.04
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Page80of86
15. Appendix4:VisualCheck
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15.1. Intendeduse
• VisualCheckisanautomatedvisualevaluationofimagesofthecervixthatprovidesinformationthat
maybeusefulinthecharacterizationofsuspectedpositivefindingsofcolposcopyduringimage
interpretation.VisualCheckisadigitalcomputeraidedtriageandnotificationsoftwareindicatedforuse
intheanalysisofnonenhanceddigitalimagesascapturedonadigitalcolposcope.VisualCheckisused
bytrainedclinicianstogetherwithadditionalinformationtodecideonprioritizationofcasesorthe
continuedcareofpatients.
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• VisualCheckisintendedto assisthospitalnetworksandclinicianstrainedincolposcopyandvisual
inspectionofthecervixinworkflowtriagebyflaggingandcommunicationofsuspectedpositivefindings
ofcolposcopyandmustalwaysaccompanyathoroughlyperformedvisualizationofthecervix.
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VisualCheckforclinicaldecisionsupportshouldbeusedonlyafteratrainedclinicianperformsavisual
examinationofthecervixandprovidesinformationthatcanbeusedbytheclinician.VisualCheckisNOT
asubstituteforavisualexaminationthroughadigitalcolposcopeandtheclinicianmustALWAYS
conductathoroughvisualexaminationpriortousingtheVisualCheck.
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• VisualCheckistobeusedbyacliniciantrainedincolposcopyand/orvisualinspectionofthecervixwho
performsavisualizationofthecervixduringacervicalcancerscreeningprocedure.
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15.2. Targetpopulation
15.2.1. Thetargetpopulationofthisapplicationiswomenbetweentheagesof30to49.
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15.3. WarningsandPrecautions
15.3.1. VisualCheckiscurrentlynotavailableintheUSA.Pleaseseeyourdistributortoknowyourlocal
availabilityinotherregions
15.3.2. TheVisualCheckassessmentisnotcompatiblewiththefollowing:
• Imagesinwhichaceticacidhasnotbeenadequatelyappliedtothecervix
• Mucusonthecervixobscuringvisualizationofanyofthesquamocolumnarjunction(SCJ)
• Anybleeding,discharge,orotherfeaturethatobscuresthesurfaceofthecervix,particularlyaroundthe
squamocolumnarjunction.
• Presenceofvaginalwallretraction,oranyotheranatomicalabnormalitythatpreventsfullvisibilityof
thesquamocolumnarjunctionandtransformationzone(TZ).
• Partsofthespeculumorswabobstructfullvisibilityofthesquamocolumnarjunctionand
transformationzone
• Imagesinwhichthequamocolumnarjunctionisnotfullyvisible,includingtypeIIIcervix
15.3.3. VisualCheckshouldnotbeusedonpregnantormenopausalwomenorwomenwhosesquamo
columnarjunctionisnotfullyvisible(cervixtype3)
15.3.4. VisualCheckisnotregulatedasadiagnostictoolandshouldnotbeusedaloneasreplacementforafull
andthoroughvisualizationorcolposcopicexamination
15.3.5. Pleasenote:atthistimeVisualCheckisonlyavailableforEVASystemusers.
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