GE CARESCAPE ONE - SpO2 displayed saturation values

Parameterspecications
SpO
2
displayedsaturationvalues
GETruSignal,MasimoSETandNellcorOxiMaxpulseoximetryarecalibratedtodisplay
functionalsaturation.
NOTE
Youcanverifythefunctionalityofpulseoximetersensorand
monitorwithafunctionalSpO
2
testerbutyoucannotevaluate
theiraccuracywithsuchadevice.Formoreinformation,
refertothestandardISO80601-2-61:2011-04AnnexFF
(Simulators,calibratorsandfunctionaltestersforpulse
oximeterequipment).
SpO₂summaryofclinicalstudiesusedto
establishaccuracyclaims
AccuracyofNellcor
™
sensorswithOximax
™
technology
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.
NeonatespecicationsareshownforOxiMaxMAXNsensorswiththepulseoximeter.
Clinicalfunctionalityhasbeendemonstratedonapopulationofhospitalizedneonate
patients.TheobservedSpO
2
accuracywas2.5%inastudyof42patientswithagesof
1to23days,weightfrom750to4,100grams,and61observationsmadespanning
arangeof77%to98%SaO
2
.
AccuracyofMasimoSETtechnologywithMasimoSET
sensors
TheMasimoSETTechnologywithMasimosensorshasbeenvalidatedfornomotion
accuracyinhumanbloodstudiesonhealthyadultmaleandfemalevolunteerswith
lighttodarkskinpigmentationininducedhypoxiastudiesintherangeof70-100%
SpO2againstalaboratoryco-oximeterandECGmonitor.Thisvariationequals±1
standarddeviation.Plusorminusonestandarddeviationencompasses68%ofthe
population.
Fordetailedinformation,refertothesupplementalanalysisgraphsintheappendix
(BlandandAltman.Agreementbetweenmethodsofmeasurementwithmultiple
observationsperindividual.JournalofBiopharmaceuticalStatistics(2007)vol.17
pp.571-582).
2094480-001CARESCAPEONE301
CARESCAPE ONE User Manual DRAFT 26 October 2017