VivaQuant Rhythm Express RX-1 - Intended Use; Contraindications; Indications for Use

Chapter2:Overview
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7
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Intended Use
TheRhythmExpressremotecardiacmonitoringsystemisintendedforusebypatientswhoeitherhaveorareatriskof
havingcardiacdiseaseandthosethatdemonstrateintermittentsymptomsindicativeofcardiacdiseaseandrequirecardiac
monitoringonacontinuingbasis.ThedevicecontinuouslyrecordsECGdataandupondetectionbyanECGanalysis
algorithmormanuallyinitiatedbythepatient,automaticallydeliverstherecordedcardiacactivitytotheserverwhereitis
presentedandcanbereviewedbyamedicalprofessional.
ThedatareceivedfromtheRhythmExpressdevicecanbeusedbyanotherdeviceforarrhythmiaanalysis,reportingand
signalmeasurements.TheRhythmExpressremotecardiacmonitoringsystemisnotintendedtosoundanyalarms.
Thedevicedoesnotdeliveranytherapy,administeranydrugs,provideinterpretiveordiagnosticstatementsorprovidefor
anylifesupport.
Contraindications
1. Patientsundertheageof18
2. Patientswithpotentiallylife‐threateningarrhythmiaswhorequireinpatientmonitoring.
3. Patientswhotheattendingphysicianthinksshouldbehospitalized.
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Indications for Use
TheRX‐1ECGmonitorwitharrhythmiadetectionisintendedforuseinthefollowingindications:
 Adultpatientswhohaveademonstratedneedforcardiacmonitoring.Thesemayincludebutarenotlimitedto
patientswhorequiremonitoringfor:a)non‐life‐threateningarrhythmiassuchassupraventriculartachycardias
(e.g.atrialfibrillation,atrialflutter,PACs,PSVT)andventricularectopy;b)evaluationofBradyarrhythmiasand
intermittentbundlebranchblock,includingaftercardiovascularsurgeryandmyocardialinfarction;andc)
arrhythmiasassociatedwithco‐morbidconditionssuchashypothyroidismorchroniclungdisease.
 Patientswithsymptomsthatmaybeduetocardiacarrhythmias.Thesemayincludebutarenotlimitedto
symptomssuchas:a)dizzinessorlightheadedness;b)syncopeofunknownetiologyinwhicharrhythmiasare
suspectedorneedtobeexcluded;andc)dyspnea(shortnessofbreath).
 Patientswithpalpitationswithorwithoutunknownarrhythmiastoobtaincorrelationofrhythmwithsymptoms.
 Patientswhorequireoutpatientmonitoringofantiarrhythmictherapy:a)monitoringoftherapeuticandpotential
proarrhythmiceffects(e.g.QTprolongation)ofmembraneactivedrugs;andb)monitoringofeffectivedrugsto
controlventricularrateinvariousatrialarrhythmias(e.g.atrialfibrillation).
 Patientsrecoveringfromcardiacsurgerywhoareindicatedforoutpatientarrhythmiamonitoring.
 Patientswithdiagnosedsleepdisorderedbreathingincludingsleepapnea(obstructive,central)toevaluate
possiblenocturnalarrhythmias.
 Patientsrequiringarrhythmiaevaluationofetiologyofstrokeortransientcerebralischemia,possiblysecondaryto
atrialfibrillation.
Comment [bp1]: Changesheremustbemade
everywhere.Theindicationsarepubliclyapproved
duringthe510(k).Theymustbeconsistentinall
labellingandrequirements.