GE CARESCAPE ONE - NIBP Standards Compliance; NIBP Performance Specifications

Parameterspecications
NIBPstandardscompliance
ThesystemcomplieswithIEC80601-2-30:2013-07.
ThesystemwasclinicallytestedaccordingtoISO81060-2:2013.Themeasurement
hasbeenvalidatedwithpatientpopulationsrequiringclinicalinvestigationsaccording
toISO81060-2:2013apartfrompregnantandpre-eclampticwomen.
Thenon-invasivebloodpressureAPPLIEDPARTisclassiedasaDEFIBRILLATION
PROOFTYPEBFperIEC80601-2-30:2013Clause201.6and201.8.5.5.101.
NIBPperformancespecications
NIBPmeasurementtechniqueOscillometric
NIBPdisplayedparametersSystolic,diastolic,andmeanpressures,timeoflastmeasurement,
cuffpressure
NIBPmeasurementsupportedmodesManual,Auto,andSTAT
NIBPmeasurementrange
●Adult:15to300mmHg(2.0to40.0kPa)
●Child:15to260mmHg(2.0to34.7kPa)
●Infant:15to155mmHg(2.0to20.7kPa)
NIBPmeasurementrangeaccuracy
±5mmHg(0.7kPa)averageerror,8mmHg(1.1kPa)standard
deviation
NIBPmeasurementdisplayresolution
1mmHg
NIBPmeasurementdefaultinitial
inationpressure
●Adult:135mmHg(18.0kPa)
●Child:125mmHg(16.7kPa)
●Infant:100mmHg(13.3kPa)
NOTE
IntheNICUsoftwarepackage,infant
rangesareequaltoneonatalranges.
Supportedcuffsizes●Disposable:Largeadult,adult,smalladult,pediatric,child,
andneonatal
●Reusable:Adultthigh,largeadult,adult,smalladult,small
adult/child,child,andinfant
Cuffpressurerange0to315mmHg(0.0to42.0kPa)
NIBPcuffpressuredisplayresolution
1mmHg
Cuffmaximuminationpressure●Adult:290±6mmHg(38.7±0.8kPa)
●Child:250±5mmHg(33.3±0.7kPa)
●Infant:145±5mmHg(19.3±0.7kPa)
NIBPmeasurementavailableautomatic
cycletimes
1min,2min,2.5min,3min,4min,5min,10min,15min,20min,
30min,1h,2h,and4h
Autozero
Autozeropressurereference
318CARESCAPEONE2094480-001
CARESCAPE ONE User Manual DRAFT 26 October 2017