GE CARESCAPE ONE - Spo₂ Test Methods Used to Establish Accuracy Claims During Low Perfusion; Low Perfusion Accuracy of Nellcor Oximax Technology with Oximax Sensors; Low Perfusion Accuracy of Masimo SET Technology; Low Perfusion Accuracy of GE Trusignal Technology with Trusignal Sensors

Parameterspecications
Subjectscomprisedbothadultmenandwomenandspannedarangeofskin
pigmentations.
SpO₂testmethodsusedtoestablishaccuracy
claimsduringlowperfusion
LowperfusionaccuracyofNellcorOximaxtechnologywith
Oximaxsensors
Specicationappliestomonitoringcableperformance.Readingaccuracyinthe
presenceoflowperfusion(detectedIRpulsemodulationamplitude0.03%-1.5%)was
validatedusingsignalssuppliedbyapatientsimulator.SpO
2
andpulseratevalues
werevariedacrossthemonitoringrangeoverarangeofweaksignalconditionsand
comparedtotheknowntruesaturationandpulserateoftheinputsignals.
LowperfusionaccuracyofMasimoSETtechnology
TheMasimoSETtechnologyhasbeenvalidatedforlowperfusionaccuracyinbench
toptestingagainstBiotekIndex2
TM
simulatorandMasimo'ssimulatorwithsignal
strengthsofgreaterthan0.02%andtransmissionofgreaterthan5%forsaturations
rangingfrom70to100%.Thisvariationequals±1standarddeviation.Plusorminus
onestandarddeviationencompasses68%ofthepopulation.
LowperfusionaccuracyofGETruSignaltechnologywith
TruSignalsensors
GETruSignaltechnologywithTruSignalsensorshavebeenvalidatedforlowperfusion
accuracyinasimulatortestforsaturationrangingfrom70%to100%.Thetestwas
conductedusingaFlukeProSim8simulatorusing0.03%pulseamplitudeandThin
Fingertransmissionsetting.
SpO₂testmethodsusedtoestablishpulserate
accuracy
PulserateaccuracyofNellcorOximaxtechnologywith
Oximaxsensors
Accuracyspecicationswerevalidatedusingmeasurementsofhealthynon-smoking
adultvolunteersduringcontrolledhypoxiastudiesspanningthespeciedsaturation
ranges.Subjectswererecruitedfromthelocalpopulationandcomprisedbothmen
andwomenranginginagefrom18-50yearsold,andspannedarangeofskin
pigmentations.PulseoximeterSpO
2
readingswerecomparedtoSaO
2
valuesofdrawn
bloodsamplesmeasuredbyhemoximetry.Allaccuraciesareexpressedas±1SD.
Becausepulseoximeterequipmentmeasurementsarestatisticallydistributed,about
two-thirdsofthemeasurementscanbeexpectedtofallinthisaccuracy(A
RMS
)range.
AdultspecicationsareshownforOxiMaxMAXAandMAXNsensorswiththepulse
oximeter.
2094480-001CARESCAPEONE303
CARESCAPE ONE User Manual DRAFT 26 October 2017