GE MAC 600 - Classification

Introduction
WARNING:
SUPERVISEDUSEThisequipmentisintendedforuseunderthedirectsupervisionofalicensed
healthcarepractitioner.
WARNING:
POWERREQUIREMENTSBeforeconnectingthedevicetothepowerline,checkthatthevoltage
andfrequencyratingsofthepowerlinearethesameasthoseindicatedontheunit'slabel.
WARNING:
INTERPRETATIONHAZARDComputerizedinterpretationisonlysignicantwhenusedin
conjunctionwithclinicalndings.
Aqualiedphysicianmustoverreadallcomputer-generatedtracings.
WARNING:
SHOCKHAZARDImproperuseofthisdevicepresentsashockhazard.Strictlyobservethe
followingwarnings.Failuretodosomayendangerthelivesofthepatient,theuser,and
bystanders.
Whendisconnectingthedevicefromthepowerline,removetheplugfromthewalloutletrst,
beforedisconnectingthecablefromthedevice,otherwise,thereisariskofcomingincontact
withlinevoltagebyinadvertentlyintroducingmetalpartsinthesocketsofthepowercord.
Devicesmaybeconnectedtootherdevicesortopartsofsystemsonlyaftermakingcertain
thatthereisnodangertothepatient,theoperators,ortheenvironmentasaresult.Standards
IEC60601-1-1/EN60601-1-1mustbecompliedwithinallcases.
Classication
Theunitisclassied,accordingtoIEC60601-1,as:
TypeofprotectionagainstelectricalshockClassImedicaldevice
DegreeofprotectionagainstelectricalshockTypeCFdebrillation-proofappliedpart
DegreeofprotectionagainstingressofwaterOrdinaryEquipment(enclosedequipment
withoutprotectionagainstingressofwater)
2047426-001KMAC™60021