GE CARESCAPE - B650 indications for use; B450 indications for use

Safety
TheCARESCAPEMonitorB850canbeastand-alonemonitororinterfacedtoother
devices.Itcanalsobeconnectedtoothermonitorsforremoteviewingandtodata
managementsoftwaredevicesviaanetwork.
TheCARESCAPEMonitorB850isintendedforuseunderthedirectsupervisionof
alicensedhealthcarepractitioner,orbypersonneltrainedinproperuseofthe
equipmentinaprofessionalhealthcarefacility.
TheCARESCAPEMonitorB850isnotintendedforuseduringMRI.
B650indicationsforuse
TheCARESCAPEMonitorB650isamulti-parameterpatientmonitorintendedforusein
multipleareasandintrahospitaltransportwithinaprofessionalhealthcarefacility.
TheCARESCAPEMonitorB650isintendedforuseonadult,pediatric,andneonatal
patientsandononepatientatatime.
TheCARESCAPEMonitorB650isindicatedformonitoringof:
●hemodynamic(includingECG,STsegment,arrhythmiadetection,ECGdiagnostic
analysisandmeasurement,invasivepressure,non-invasivebloodpressure,pulse
oximetry,cardiacoutput(thermodilutionandpulsecontour),temperature,mixed
venousoxygensaturation,centralvenousoxygensaturation,andSurgicalPleth
Index),
●respiratory(impedancerespiration,airwaygases(CO
2
,O
2
,N
2
O,andanesthetic
agents),spirometry,gasexchange),and
●neurophysiologicalstatus(includingelectroencephalography,Entropy,Bispectral
Index(BIS),andneuromusculartransmission).
TheCARESCAPEMonitorB650alsoprovidesalarms,trends,snapshotsandevents,
andcalculations,andcanbeconnectedtodisplays,printersandrecordingdevices.
TheCARESCAPEMonitorB650canbeastand-alonemonitororinterfacedtoother
devices.Itcanalsobeconnectedtoothermonitorsforremoteviewingandtodata
managementsoftwaredevicesviaanetwork.
TheCARESCAPEMonitorB650isintendedforuseunderthedirectsupervisionof
alicensedhealthcarepractitioner,orbypersonneltrainedinproperuseofthe
equipmentinaprofessionalhealthcarefacility.
TheCARESCAPEMonitorB650isnotintendedforuseduringMRI.
B450indicationsforuse
TheCARESCAPEMonitorB450isamulti-parameterpatientmonitorintendedforusein
multipleareasandintrahospitaltransportwithinaprofessionalhealthcarefacility.
TheCARESCAPEMonitorB450isintendedforuseonadult,pediatric,andneonatal
patientsandononepatientatatime.
TheCARESCAPEMonitorB450isindicatedformonitoringof:
●hemodynamic(includingECG,STsegment,arrhythmiadetection,ECGdiagnostic
analysisandmeasurement,invasivepressure,non-invasivebloodpressure,pulse
oximetry,cardiacoutput(thermodilutionandpulsecontour),temperature,mixed
venousoxygensaturation,centralvenousoxygensaturation,andSurgicalPleth
Index),
●respiratory(impedancerespiration,airwaygases(CO
2
,O
2
,N
2
O,andanesthetic
agents),spirometry),and
2062971-001CARESCAPEModularMonitors49