Safety
TheCARESCAPEONEisindicatedforthemonitoringofhemodynamic(includingECG,
STsegment,arrhythmiadetection,invasivepressure,non-invasivebloodpressure,
pulseoximetry,andtemperature),andrespiratory(impedancerespirationandCO
2
airwaygas)physiologicalparameters.
TheCARESCAPEONEincludesanintegrateddisplay,touchscreen,alarmlight,
userinputbuttons,andanaudiosubsystem.Real-timephysiologicalparameter
measurementsandwaveformsaredisplayedontheintegrateddisplay.Visualalarms
areconveyedusingboththeintegrateddisplayandalarmlight.Audiblealarmsare
conveyedusingtheintegratedaudiosubsystem.Userinputforcongurationcontrol
andinteractionisprovidedviathetouchscreen.Inaddition,bothapowerbuttonand
touchscreenlockbuttonareprovided.
TheCARESCAPEONEcanbeusedasastandalonemonitor.Inthismodeofoperation,
theCARESCAPEONEprovidesECG,STsegment,arrhythmiadetection,impedance
respiration,SpO
2
,non-invasivebloodpressure,invasivepressure,temperature,and
CO
2
airwaygasparameteracquisitionandmonitoring.
TheCARESCAPEONEcanbeconnectedasanaccessorytotheCARESCAPEMonitor
B850.Inthismodeofoperation,theCARESCAPEONEprovidesECG,STsegment,
impedancerespiration,SpO
2
,non-invasivebloodpressure,invasivepressure,
temperature,andCO
2
airwaygasparameteracquisition.Visualandaudiblealarms,
usercontrols,anduserinterfaceontheCARESCAPEONEarenotactiveinthismode.
TheCARESCAPEONEisintendedforuseonadult,pediatric,andneonatalpatients
andononepatientatatime.
TheCARESCAPEONEisintendedforuseunderthedirectsupervisionofalicensed
healthcarepractitioner,orbypersonneltrainedintheproperuseoftheequipmentin
aprofessionalhealthcarefacility.
TheCARESCAPEONEisnotintendedforusewithinacontrolledMRenvironment.
Indicationsforusesafetyprecautions
Indicationsforusewarnings
WARNING
Readallthesafetyinformationbeforeusingthedevicefor
thersttime.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.
2094480-001CARESCAPEONE
33
CARESCAPE ONE User Manual DRAFT 26 October 2017