GE MAC 600 - Certification Information

Introduction
Degreeofsafetyofapplicationinthepresence
ofaammableanestheticmixturewithairor
withoxygenornitrousoxide
Equipmentnotsuitableforuseinthepresence
ofaammableanestheticmixturewithairor
withoxygenornitrousoxide
Method(s)ofsterilizationordisinfection
recommendedbythemanufacturer
Notapplicable
Modeofoperation
Continuousoperation
CerticationInformation
TheMAC600systembearstheCEmark“CE-0459”,notiedbody
GMED,indicatingitsconformitywiththeprovisionsoftheCouncil
Directive93/42/EEC,concerningmedicaldevicesandfullsthe
essentialrequirementsofAnnexIofthisdirective.
Themedicaldevicehasalifetimeof7yearswithrespecttothe
CouncilDirective93/42/EECessentialrequirement#4.
MedicalEquipment
Classiedwithrespecttoelectricshock,re,mechanical,and
otherspeciedhazardsonlyinaccordancewithUL60601-1,
CAN/CSAC22.2No.601.1,IEC60601-2-25,IEC60601-1,IEC
60601-1-2,IEC60601-2-51.
22MAC™6002047426-001K