GE CARESCAPE ONE - Indications for Use Cautions; Training Requirements; Electromagnetic Compatibility; EMC Warnings

Safety
WARNING
INTRAHOSPITALTRANSPORT.Vibrationsduringintrahospital
transportmaydisturbSpO
2
,ECG,impedancerespiration,NIBP,
andIPmeasurements.
Indicationsforusecautions
CAUTION
U.S.Federallawrestrictsthisdevicetosalebyorontheorder
ofaphysician.
CAUTION
SUPERVISEDUSE.Thisequipmentisintendedforuseunder
thedirectsupervisionofalicensedhealthcarepractitioner.
Trainingrequirements
Noproduct-specictrainingisrequiredfortheuseoftheCARESCAPEONE.
Electromagneticcompatibility
EMCwarnings
WARNING
Useonlyapprovedaccessories,includingmounts,and
debrillator-proofcablesandinvasivepressuretransducers.
Foralistofapprovedaccessories,seethesupplemental
informationprovided.Othercables,transducersand
accessoriesmaycauseasafetyhazard,damagethe
equipmentorsystem,resultinincreasedemissionsor
decreasedimmunityoftheequipmentorsystem,orinterfere
withthemeasurement.
WARNING
PinsofconnectorsidentiedwiththeESDwarningsymbol
shouldnotbetouched.Connectionsshouldnotbemade
totheseconnectorsunlesselectrostaticdischarge(ESD)
precautionsareused.
WARNING
Donotusethedeviceinhighelectromagneticelds(for
example,duringmagneticresonanceimaging).
WARNING
EMC.Magneticandelectricaleldsarecapableofinterfering
withtheproperperformanceofthedevice.Forthisreason
makesurethatallexternaldevicesoperatedinthevicinityof
themonitorcomplywiththerelevantEMCrequirements.X-ray
equipmentorMRIdevicesareapossiblesourceofinterference
astheymayemithigherlevelsofelectromagneticradiation.
Changesormodicationstothisdevice/systemnotexpressly
approvedbyGEmaycauseEMCissueswiththisorother
equipment.Thisdevice/systemisdesignedandtestedto
complywithapplicablestandardsandregulationsregarding
EMCandneedstobeinstalledandputintoserviceaccording
totheEMCinformationstatedasfollows:Thisdevice/system
issuitableforuseinallestablishmentsotherthandomestic
andthosedirectlyconnectedtothepubliclow-voltagepower
supplynetworkthatsuppliesbuildingsusedfordomestic
purposes.Mainspowershouldbethatofatypicalcommercial
orhospitalenvironment.DeviceiscomplianttoClassA.
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CARESCAPEONE2094480-001
CARESCAPE ONE User Manual DRAFT 26 October 2017