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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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