GE MAC 2000 - Contraindications; Regulatory and Safety Information

Introduction
Contraindications
Thissystemisnotintendedforuseinthefollowingmanner:
•Duringpatienttransport
•Withhigh-frequencysurgicalunits
•Asanintra-cardiacapplication
•Asavitalsignsphysiologicalmonitor
PrescriptionDeviceStatement
CAUTION:
UnitedStatesfederallawrestrictsthisdevicetosalebyorontheorderofa
physician.
RegulatoryandSafetyInformation
Thissectionprovidesinformationaboutthesafeuseandregulatorycomplianceof
thissystem.Familiarizeyourselfwiththisinformation,andreadandunderstandall
instructionsbeforeattemptingtousethissystem.Thesystemsoftwareisconsidered
medicalsoftware.Assuch,itwasdesignedandmanufacturedtotheappropriate
medicalregulationsandcontrols.
NOTE:
Disregardingthesafetyinformationprovidedinthismanualisconsidered
abnormaluseofthissystemandcouldresultininjury,dataloss,oravoided
warranty.
SafetyConventions
AHazardisasourceofpotentialinjurytoaperson,property,orthesystem.
ThismanualusesthetermsDANGER,WARNING,CAUTION,andNOTICEtopointout
hazardsandtodesignateadegreeorlevelofseriousness.Familiarizeyourselfwith
thefollowingdenitionsandtheirsignicance.
DenitionsofSafetyConventions
Safety
Convention
Denition
DANGER
Indicatesanimminenthazard,which,ifnotavoided,willresultindeath
orseriousinjury.
WARNING
Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultindeathorseriousinjury.
CAUTION
Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinmoderateorminorinjury.
NOTICE
Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinthelossordestructionofpropertyordata.
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MAC™2000ECGAnalysisSystem
2053535-003C