GE CARESCAPE ONE User Manual

Parameterspecications
AccuracyofGETruSignaltechnologywithTruSignalsensors
TheGETruSignaltechnologywithTruSignalsensorshasbeenvalidatedforno
motionaccuracyincontrolledhypoxiastudieswithhealthynon-smokingadult
volunteersoverthespeciedsaturationSpO
2
range(s).PulseoximeterSpO
2
readings
werecomparedtoSaO
2
valuesofdrawnbloodsamplesmeasuredbyalaboratory
co-oximeter.Subjectscomprisedbothhealthyadultmenandwomenandspanneda
rangeofagesandskinpigmentations.
Formoredetailedinformation,refertothesupplementalanalysisgraphsinthe
appendix(BlandandAltman.Agreementbetweenmethodsofmeasurementwith
multipleobservationsperindividual.JournalofBiopharmaceuticalStatistics(2007)
vol.17pp.571-582).
SpO
2
testmethodsusedtoestablishaccuracy
claimsduringmotion
Nellcor
™
sensorsaccuracyspecicationswerevalidatedusingmeasurementsof
healthynon-smokingadultvolunteersduringcontrolledhypoxiastudiesspanning
thespeciedsaturationranges.Subjectswererecruitedfromthelocalpopulation
andcomprisedbothmenandwomenranginginagefrom18-50yearsold,and
spannedarangeofskinpigmentations.PulseoximeterSpO
2
readingswerecompared
toSaO
2
valuesofdrawnbloodsamplesmeasuredbyhemoximetry.Allaccuracies
areexpressedas±1SD.Becausepulseoximeterequipmentmeasurementsare
statisticallydistributed,abouttwo-thirdsofthemeasurementscanbeexpectedto
fallinthisaccuracy(A
RMS
)range.
Nellcor
™
sensorsmotionperformancewasvalidatedduringacontrolledhypoxia
bloodstudyoveranSaO
2
spanof70%to98.9%andaconvenience-sampleheart
rangeof41-105bpm.Subjectsperformedrubbingandtappingmovements1-2cmin
amplitudewithaperiodicintervals(randomlychanging)witharandomvariationin
frequencybetween1-4Hz.Theaveragepercentrangewasvalidatedusingsynthetic
signalsfromapatientsimulatorthatcomprisedrepresentativecardiacandsignal
artifactcomponents.Applicability:OxiMaxMAXA,MAXAL,MAXP,MAXI,andMAXN
sensors.
TheMasimoSETTechnologywithMasimosensorshasbeenvalidatedformotion
accuracyinhumanbloodstudiesonhealthyadultmaleandfemalevolunteerswith
lighttodarkskinpigmentationininducedhypoxiastudieswhileperformingrubbing
andtappingmotions,at2to4Hzatanamplitudeof1to2cmandnon-repetitive
motionbetween1to5Hzatanamplitudeof2to3cmintherangeof70%to100%
SpO
2
againstalaboratoryCO-oximeterandECGmonitor.Thisvariationequals±1
standarddeviation,whichencompasses68%ofthepopulation.
NOTE
AccuracyduringmotionhasnotbeenspeciedforMasimo
SETsensorsTC-I,TF-I,DBI,Blue,andE-1.
MeasurementmodulesusingGEOhmedaTechnologywithTS-AFandTS-APsensors
havebeenvalidatedformotionaccuracyincontrolledhypoxiastudieswithhealthy
non-smokingadultvolunteersoverthespeciedsaturationSpO
2
range(s).The
followingmotiontypeswereused:mechanicallyinduced3Hztappingmotionatan
amplitudeof1-2cm,patientinducednon-repetitiverubbingmotion,andpatient
inducednon-repetitivehandmotioninsupineposition.PulseoximeterSpO
2
readings
werecomparedtoSaO
2
valuesofdrawnbloodsamplesmeasuredbyCO-oximetry.
302CARESCAPEONE2094480-001
CARESCAPE ONE User Manual DRAFT 26 October 2017

GE CARESCAPE ONE Specifications

General

Brand	GE
Model	CARESCAPE ONE
Category	Medical Equipment
Language	English