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  • ZOE® - Fluid Status MonitorZOE® - Technical Specifications

    Class II Medical Device

    Operation:• IntermittentUse

    Power:• 5voltsDCZOE®medicalgradepoweradapter• 4AAAlkalineBatteries

    Enclosure:• Flame-resistantAVSplastic

    Dimensions:• 8”x5”x2”• 20cmx12.5cmx2cm

    Weight:• 1lbexcludingaccessories,options,cables

    Measurement Current:• 2.0mA,100kHz

    Electrodes:• ZOE®disposablehydrogelleadsonly

    Operating & Storage Temperature:• 15ºC–40ºC(40ºF–113ºF)

    Relative Humidity for Operation & Storage:• 20%-80%non-condensing

    IP20

    ThisequipmenthasbeentestedandfoundtocomplywiththeEMClimitsfortheMedicalDeviceDirective93/42EEC

    (EN55011ClassII&EN60601-1-2).Theselimitsaredesignedtoprovidereasonableprotectionagainstharmfulinterferenceinatypicalmedicalinstallation.Theequipmentgeneratesusesandcanradiateradiofrequencyenergyand,ifnotinstalledanduseinaccordancewiththeseinstruction,maycauseharmfulinterferencetootherdevicesinthevicinity.

    ZOE® is a registered trademark of the NMT CorporationSpecifications subject to change without notice.

    6412SouthArvilleStreetLasVegas,Nevada89118888-466-8552www.nmtinc.org

    • Detectcongestiveheartfailureasearlyastwoweekspriortoweightgain• Lightweight,easytouseandaffordableforHomeCare

    • Power:ACorAABatteries• FDA(510k) Cleared

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    All Med Medical Supply800-434-2909

    www.amms.net

  • About ZOE®TheZOE®FluidStatusMonitorwasdesignedforobjectivelymonitoringfluidlevels.

    TheZOE®measuresthoracicbaseimpedancewhichissimplyameasurementoftheresistanceofasmallfrequencyelectriccurrentasittravelsfromthetoptothebottomofthethorax.

    Themoreresistancethecurrentmeets,thedrierorlessfluidthatexistsandconversely,thelessresistancethatthecurrentmeets,thewetterormorefluidthatexistsinthechest.

    Zomeasurementisaquickandeasymethodfordeterminingwhetherindividualsareexperiencingfluidcongestionordehydration.ResearchindicatesthatZoisanearlypredictorofcongestioninheartfailure,showingdecreasesasearlyastwoweekspriortoweightgain.(LasaterM.,VonReudenKT.Outpatientcardiovascularmanagementutilizingimpedancecardiography.AACNClinicalIssues.14(2):240-250,2003.)

    What is Zo?Zorefersto“Znaught”,orbaseresistanceinohms.Thesymbolforelectricalresistanceorohmsis“Ω”.Zohasbeenmeasuredforyearsincardioplethysmographtechnology.NormalZoinhumansubjectshasbeendeterminedtorangefrom19-30ohms.Lessthan19ohmsindicatesthatthesubjectmaybeover-hydratedandZogreaterthan30indicatesthatthesubjectisbecomingdehydrated.

    Indications for UseTheZOE®monitorisFDAclearedformonitoringof:

    • Patientslivingwithfluidmanagementproblems• Patientstakingdiureticmedication• Patientslivingwithheartfailure• PatientslivingwithEnd-StageRenalDisease• Patientsrecoveringfromacoronaryarterydiseaserelatedevent• Patientssufferingfromrecurrentdehydration

    Contraindications• Patientswithallergiestoelectrodehydrogel• Patientswithskinsensitivitiestoelectrodehydrogel• PatientswithskinbreakdowninareasonthechestwhereZOE®electrodeplacementisrequired

    Thisdeviceisintendedforusebyqualifiedhealthcarepractitioners,underthedirectionofaphysician,forthenoninvasivemonitoringandmanagementofpatientswithfluidmanagementproblemsinavarietyofmedicallyacceptedclinicalapplications.

    TheZOE®providesobjectivedatafortheearlyinterventionofheartfailure,dyspnea,hypertension,andothercriticaleventsrelatedtohemodynamicstatus.

    *ThisiswhenhomecarenursinginterventionmustoccurtopreventCHFandhospitalization.(FrantzA.Breakingdownthebarrierstoheartfailurepatientself-care.HomeHealthcareNurseJournal.22(2):109-115,2004.)

    Early Signs & SymptomsExacerbation

    Late Signs & SymptomsExacerbation

    AcuteExacerbation

    AppetiteFatigue

    Bloatedfeeling*Fullnessinears

    Zo

    Peripheraledema SOBwithexertion

    Weightgain Abdominalgirth Pillowuse

    Developsacough

    Pittingedema SOBatrestDevelopsS3

    DevelopscracklesSaO2JVD

    Zolessthan15ohms

    Patient Benefits Physician Benefits

    • Decreasedemergencyroomvisitsandre- hospitalizations• Feelingofsecurityrelatedtoobjectivevaluesplacedonfluidmeasurement

    • Improvementinfunctionalcapabilities• Highdegreeofsatisfactioninmedicalcare• Higherlevelofawarenessandunderstandingofdiseaseprocessandtreatment

    • Promotesactiveparticipationinself-care

    • Improvedpatientmanagement• Moreefficientuseoftimeandresources• Focusedobjectivereportingofclinicaldata• Documentation/datatosupportdiagnosticstudies/decreaseinvasivestudies