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ELECTRICAL IMPEDANCE COMPUTER MAMMOGRAPH · PDF fileElectrical impedance computer mammograph MEIK® 5.0 for mammary gland screening by means of ... Colour Scale

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  • ELECTRICALIMPEDANCECOMPUTERMAMMOGRAPHMEIK5.6

    USERMANUALCE1023

    PKFModernImpedanceMedicalEquipment

    www.impedance.ru

    All rights reserved. No part of this document may be copied, reproduced or distributed in any

    form without express written permission from PKF SIM-technika.

  • PERMITSANDREGULATORYDOCUMENTS

    PKF "SIMtechnika" Ltd possesses medical equipment manufacturing licence (RegistrationNumber9903002246,December9,2010withappendices).ElectricalimpedancecomputermammographMEIK5.0formammaryglandscreeningbymeansofelectricalconductivitydistributionpatternvisualizationwithsoftwareversion5.6(hereinafterreferred toasMEIK5.0) isgrantedwith the registration certificate#29/050010303/542003dated July 3, 2003 and the Declaration of Conformity RU.02.00518 datedSeptember26,2012.The safetyofMEIK5.0with softwareversion5.6was certifiedaccording toCouncilDirective93/42EECMDDby ITC (CzechRepublic).MEIKwasawardedwith theEuropeancertificateCE1023withtherighttoaffixtheCEmarkingrightattheproduction.Quality Management System implemented by OOO PKF "SIMtechnika" is certified by DQS,GermanyandconformstotherequirementsofISO9001:2008,ENISO13485:2003+AC:2009.MEIK software version 5.6 is officially registered in theRussian FederationwithRegistrationCertificate#2009611472.Trademarks and logos of SIMTechnika and MEIK officially registered in the RussianFederationandarethepropertyofOOOPKF"SIMtechnika"Ltd.MEIK5.0 ismanufacturedaccordingtoTU9442001181006762003asamended.MEIK5.0 isprotectedbyEurasianpatentfortheinvention#012006withthepriorityrightfromJuly5,2007.

    AllreferencestotradenamesofothercompanieswithinthisUserManualareprovided fortheiridentificationsolelywithoutanyinfringementoftheirrightsandshallnotbeconsideredasacommercialoranadvertisement.

  • TableofContents

    Introduction.......................................................................5ProductFeatures........................................................................................5

    Productoperation..................................................7HowtoPreparetheDeviceforOperation.................................................8

    Softwareinstallation.....................................................................8ConnectiontoPC...........................................................................8PatientsDataInput......................................................................9PatientsCardFilling.....................................................................9Measurements............................................................................10

    PatientsPreparation...............................................................................11PatientsPosition........................................................................11BreastPosition............................................................................11Moistening..................................................................................11RemoteElectrode.......................................................................11ElectrodesPanelFixation............................................................11Note.............................................................................................12

    MammaryGlandExamination.................................................................13BeginningMeasurement.............................................................13LastMeasurements.....................................................................13MeasurementDuration..............................................................13

    ImageReconstruction...............................................................................14ReconstructionMethodSelection..............................................14ReconstructionDuration.............................................................14AddingComments.......................................................................14

    SoftwareOperation...........................................15DiagnosticsMode..................................................15ControlButtonsField................................................................................15InformationBlock.....................................................................................16

    List...............................................................................................16Search..........................................................................................16NewPatient.................................................................................17PatientsCard..............................................................................18Archive........................................................................................20Measurement..............................................................................20Information.................................................................................21Editing.........................................................................................21

    QualitativeAnalysisBlock........................................................................22OneWindowMode....................................................................22Highlighting.................................................................................23Contrast.......................................................................................23ColourScale.................................................................................24

  • Parameters..................................................................................24QuantitativeAnalysisBlock.....................................................................24

    CompoundHistogram.................................................................25GraphType..................................................................................25ComparisonwithNorm...............................................................26TomogramComparison..............................................................27

    InformationTransmissionBlock..............................................................27Report.........................................................................................27Manualreport.............................................................................28AutomaticReport........................................................................29Print.............................................................................................30Copying........................................................................................30AddtoNorm................................................................................31

    ClosetheSession......................................................................................31Exit.............................................................................................................31ImagesField..............................................................................................31

    3Dimage....................................................................................32Enlargement................................................................................33Contrast.......................................................................................33Highlighting.................................................................................33ColourScale.................................................................................34ScaleCapacity.............................................................................34Histograms..................................................................................34Attachment.................................................................................35AdditionalWindow.....................................................................35

    ScreeningMode........................................................36SpecialFeatures(inContrasttoDiagnosticsMode)...................36ExaminationReport....................................................................36DefinitionofScreening...............................................................37DiagnosticCriteriaUnit...............................................................37EarlyDiagnosticsofBreastCancer..............................................37UsageofElectricalConductivityIndex........................................37HighRiskGroupFormation.........................................................38UsageofAgeRelatedElectricalConductivityScale....................38UsageofDivergencebetweenElectricalConductivityDistributionHistograms..................................................................................40Copying........................................................................................40

  • 1. Introduction

    MEIK5.0withsoftwareversion5.6calculatesrelativeelectricalconductivityoftissueswhichistheassessmentcriterionforphysiologicalandpathologicprocessesinthemammarygland,suchascancer,fibrocysticdisease,mastitis,physiologicalinvolution,lactationetc.

    1.1Deviceunpacking

    MEIK5.0 issuppliedtothecustomeronlyaftercompletionofallpreparatoryworks,testedandinfullyequipped.When thedevice arrives,unpack it immediately and check for anydamage thatmayhaveoccurredduringtransportation.CheckthepackagecontentswiththeenclosedPackingList.Ifanydefect, faultordeficiency is foundduring theacceptance inspection,notifyyourdealer(salesrepresentative)ofthedetailsimmediately.

    1.2SafetySigns

    Refertousermanual/booklet

    Generalsafetysign

    Generalprohibitorysign

    Generalwarningsign Laserhazard

    LaserhazardClass1

  • 1.3Devicefeatures

    Modeselectionfunction:screeningordiagnostics. Sevenscanplaneswithintherangefrom0.4cmto4.6cm. Visualevaluationoftheimagewith