GE CARESCAPE ONE - Pulse Rate Accuracy of Masimo SET Technology with Masimo Sensors; Pulse Rate Accuracy of GE Trusignal Technology with Trusignal Sensors; Spo 2 Performance Specifications

Parameterspecications
NeonatespecicationsareshownforOxiMaxMAXNsensorswiththepulseoximeter.
Clinicalfunctionalityhasbeendemonstratedonapopulationofhospitalizedneonate
patients.TheobservedSpO
2
accuracywas2.5%inastudyof42patientswithagesof
1to23days,weightfrom750to4,100grams,and61observationsmadespanning
arangeof77%to98%SaO
2
.
Specicationappliestomonitoringcableperformance.Readingaccuracyinthe
presenceoflowperfusion(detectedIRpulsemodulationamplitude0.03%-1.5%)was
validatedusingsignalssuppliedbyapatientsimulator.SpO
2
andpulseratevalues
werevariedacrossthemonitoringrangeoverarangeofweaksignalconditionsand
comparedtotheknowntruesaturationandpulserateoftheinputsignals.
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.
PulserateaccuracyofMasimoSETtechnologywithMasimo
sensors
MasimoSETTechnologywithMasimosensorshasbeenvalidatedforpulserate
accuracyfortherangeof25-240bpminbenchtoptestingagainstaBiotekIndex
2simulator.Thevariationequalsplusorminusonestandarddeviation,which
encompasses68%ofthepopulation.
PulserateaccuracyofGETruSignaltechnologywith
TruSignalsensors
GETruSignaltechnologywithTruSignalsensorshasbeenvalidatedforpulserate
accuracyoverthespeciedrangeinbenchtoptestingagainstapatientsimulator.
SpO
2
performancespecications
NOTE
TechnicalspecicationsgivenforCARESCAPESpO
2
–Masimoare
basedonMasimoCorporationownedMasimoSETtechnology
andsensors.Formoredetailedinformation,refertothesensor
instructionsforuse.
NOTE
TechnicalspecicationsgivenforCARESCAPESpO
2
–Nellcorare
basedonCovidienAGownedtechnologyandsensors.Formore
detailedinformation,refertothesensorinstructionsforuse.
ThefollowingspecicationsapplytoallCARESCAPESpO
2
technologiesunlessotherwise
indicated.
Pulseoximetrysaturationdisplay
resolution
1digit(%ofSpO
2
)
Pulseoximetryperipheralpulserate
displayresolution
1bpm
304CARESCAPEONE2094480-001
CARESCAPE ONE User Manual DRAFT 26 October 2017