GE CARESCAPE ONE - Arrhythmia Measurement Limitations

ECG
thedesignlimitsoftheanalysisprogram.Thus,asbeats
becomeextremelywideornarrow,orespeciallyasbeats
becomesmall,arrhythmiainterpretationperformancemay
degrade.
●Othermorphologyconsiderations.Automatedarrhythmia
detectionalgorithmsaredesignedfundamentallytodetect
signicantchangesinQRSmorphology.Ifanarrhythmia
eventispresentanddoesnotexhibitasignicantchange
fromthepatient’spredominantmorphology,itispossible
forthoseeventstoremainundetectedbythesystem.
WARNING
PAUSEDANALYSIS.Certainconditionspausearrhythmia
analysis.Whenpaused,arrhythmiaconditionsarenot
detectedandalarmsassociatedwitharrhythmiasdonot
occur.Conditionscausingpausedarrhythmiaanalysisinclude
arrhythmiaoff,arrhythmiapaused,leadsfail,alarmpause,all
alarmsoff,anddischargedpatient.
WARNING
FAILURETODETECTLETHALARRHYTHMIA.Alwaysmonitor
ECGforarrhythmiadetectionpurposes.HRcalculatedfrom
pulsatileSpO
2
waveformmaydiffersignicantlyfromECGHR
measuredvalues.UsersshouldbeawarethattheSpO2probe
offandCheckprobetechnicalalarmsescalatenohigherthan
aMediumpriority.
WARNING
FAILURETODETECTLETHALARRHYTHMIA.TheSpO
2
parameterpulsatileheartratemeasurementisbasedonthe
opticaldetectionofaperipheralowpulseandtherefore
cannotdetectarrhythmias.Thepulseoximetryparameter
shouldnotbeusedasareplacementorsubstituteforECG
basedarrhythmiaanalysis.
WARNING
ARRHYTHMIAPAUSEDalarm.TheArrhythmiapausedalarm
indicatesthatthesystemisnolongermonitoringarrhythmia
orheartratefromECG.Ifyouadjustthealarmprioritylevel
lowerthanthedefaultvalue,keepthepatientunderclose
surveillance.
Arrhythmiameasurementlimitations
●Sincethearrhythmiadetectionalgorithmsensitivityandspecicityislessthan
100%,sometimestheremaybesomefalsearrhythmiasdetectedandalsosome
truearrhythmiaeventsmaynotbedetected.Thisisespeciallytruewhenthesignal
isnoisy.
●TheECGsizeandQRSwidthsettingsaffectarrhythmiadetectionandheartrate
calculationsensitivity.
●IfQRSamplitudeislow,themonitormightnotbeabletocalculateHRandfalse
Asystole,ArrhythmiaPaused,orBradyalarmsmayoccur.
●Duringthelearningphaseofthealgorithm,arrhythmiadetectionisnotavailable.
Asaresult,thepatientconditionshouldbecloselymonitoredduringthelearning
phaseandforseveralminutesafterthelearningphasetoallowthealgorithmto
reachoptimaldetectionperformance.
116CARESCAPEONE2094480-001
CARESCAPE ONE User Manual DRAFT 26 October 2017