GE MAC 2000 - Safety Messages

Introduction
SafetyMessages
WARNING:
PATIENTSAFETY/EQUIPMENTFAILURE—Usingunauthorizedsuppliesor
accessoriescanresultinpatientinjuryorequipmentfailure.
Toensurepatientsafety,useonlysuppliesandaccessoriesmanufacturedor
validatedbyGEHealthcareandrecommendedforusewiththisdevice.
Parts,supplies,andaccessoriesmustmeettherequirementsoftheapplicable
safetystandards.Thesystemcongurationmustmeettherequirementsofthe
IEC60601/EN60601-1MedicalElectricalSystemsstandard.Usingaccessory
equipmentthatdoesnotcomplywiththeequivalentsafetyrequirementsofthis
equipmentmayleadtoareducedlevelofsafetyoftheresultingsystem.
Whenchoosingaccessories,considerthefollowing:
•Useoftheaccessoryinthepatientvicinity.
Patientvicinityisdenedasaspace,withinalocationintendedfortheexamination
andtreatmentofpatients,extending1.83m(6ft.)beyondthenormallocationof
thebed,chair,table,treadmill,orotherdevice(s)supportingthepatientduring
examinationandtreatment,andextendingverticallyto2.5m(8ft.,2.4in.)above
theoor.
•Evidencethatthesafetycerticationoftheaccessorywasperformedinaccordance
withtheappropriateIEC60601/EN60601-1standard(s).
ContactGEHealthcareforinformationbeforeconnectingthedevicetoany
accessoriesthatarenotrecommendedinthismanual.
2053535-004D
MAC™2000ECGAnalysisSystem
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