GE CARESCAPE - Indications for use safety precautions; Indications for use warnings; Indications for use cautions; Training requirements

Safety
●neurophysiologicalstatus(includingelectroencephalography,Entropy,Bispectral
Index(BIS),andneuromusculartransmission).
TheCARESCAPEMonitorB450alsoprovidesalarms,trends,snapshotsandevents,
andcalculations,andcanbeconnectedtodisplays,printersandrecordingdevices.
TheCARESCAPEMonitorB450canbeastand-alonemonitororinterfacedtoother
devices.Itcanalsobeconnectedtoothermonitorsforremoteviewingandtodata
managementsoftwaredevicesviaanetwork.
TheCARESCAPEMonitorB450isintendedforuseunderthedirectsupervisionof
alicensedhealthcarepractitioner,orbypersonneltrainedinproperuseofthe
equipmentinaprofessionalhealthcarefacility.
TheCARESCAPEMonitorB450isnotintendedforuseduringMRI.
Indicationsforusesafetyprecautions
Indicationsforusewarnings
WARNING
Readallthesafetyinformationbeforeusingthemonitorfor
thersttime.Thismanualcontainsinstructionsnecessary
tooperatethisdevicesafelyandinaccordancewithits
functionsandintendeduse.Thismanualisintendedfor
clinicalprofessionals.Clinicalprofessionalsareexpectedto
haveaworkingknowledgeofmedicalprocedures,practices
andterminology,asrequiredforthemonitoringofallpatients.
WARNING
—SINGLEPATIENTUSE—Thisequipmentisdesignedforuse
ononepatientatatime.Usingthisequipmenttomonitor
differentparametersondifferentpatientsatthesametime
compromisestheaccuracyofdataacquired.
WARNING
—INSTRUCTIONSFORUSE—Forcontinuedsafeuseofthis
equipment,itisnecessarythatthelistedinstructionsare
followed.However,instructionslistedinthismanualinnoway
supersedeestablishedmedicalpracticesconcerningpatient
care.
WARNING
—B650,B450:INTRAHOSPITALTRANSPORT—Vibrations
duringintrahospitaltransportmaydisturbSpO
2
,ECG,
impedancerespiration,NIBP,andIPmeasurements.
Indicationsforusecautions
CAUTION
U.S.Federallawrestrictsthisdevicetosalebyorontheorder
ofaphysician.
CAUTION
—SUPERVISEDUSE—Thisequipmentisintendedforuseunder
thedirectsupervisionofalicensedhealthcarepractitioner.
Trainingrequirements
Noproduct-specictrainingisrequiredfortheuseoftheCARESCAPEmodular
monitors.
50CARESCAPEModularMonitors2062971-001