GE MAC 2000 - Classification of Medical Device

Introduction
NOTE:
Followtheinstructionsprovided.Donotpositionequipmentinawaythatmakesit
difculttodisconnectthedevicewhenusinganappliancecoupler,mainsplug,or
otherseparableplugasameansofisolation.
ClassicationofMedicalDevice
Thedeviceisclassiedasfollows,accordingtoIEC60601-1:
MedicalDeviceClassications
Category
Classication
Typeofprotectionagainstelectrical
shock
ClassIinternallypoweredequipment
Degreeofprotectionagainstelectrical
shock
TypeCFdebrillation-proofappliedpart
DegreeofprotectionagainstsolidsTheIPcodeforthisdeviceisIP20.
Protectedagainstsolidforeignobjectswitha
diameterof12.5mmandgreater
Theobjectprobe,asphere12.5mmdiameter,
shallnotfullypenetrate.Thejointedtestnger
12mmdiameter,80mmlength,shallhave
adequateclearancefromhazardousparts.
Degreeofprotectionagainstharmful
ingressofliquids(IP20)
TheIPcodeforthisdeviceisIP20.
Non-protected
Thisdeviceisordinaryequipment(enclosed
equipmentwithoutprotectionagainstingress
ofliquids)
Degreeofsafetyofapplicationinthe
presenceofammableanesthetic
mixturewithairorwithoxygenorwith
nitrousoxide
Equipmentisnotsuitableforuseinthepresence
ofaammableanestheticmixturewithairor
withoxygenorwithnitrousoxide
Method(s)ofsterilizationordisinfection
recommendedbythemanufacturer
Notapplicable
Modeofoperation
Continuousoperation
CerticationInformation
MedicalEquipment
Withrespecttoelectricshock,re,andmechanicalhazardsonlyin
accordancewithUL60601–1,andCAN/CSAC22.2NO.601.1.
RecordingECGsDuringDebrillation
Thisequipmentisprotectedagainsttheeffectsofcardiacdebrillatordischarge
toensurerecovery,asrequiredbyteststandards.Thepatientsignalinputofthe
acquisitionmoduleisdebrillation-proof.Therefore,itisnotnecessarytoremove
theECGelectrodespriortodebrillation.
2053535-003C
MAC™2000ECGAnalysisSystem
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