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
