GE MAC 2000 - Biocompatibility; Legal Notice; Supplies and Accessories

Introduction
Thesedevicesarealsopossiblesourcesofinterferenceastheymayemithigher
levelsofelectromagneticradiation.
WARNING:
EQUIPMENTMALFUNCTION/INTERFERENCE—Useofportablephonesorother
radiofrequency(RF)emittingequipmentnearthesystemmaycauseunexpected
oradverseoperation.
Donotuseportablephonesorotherelectronicequipmentthatmayemitradio
frequency(RF)nearthissystem.
WARNING:
EQUIPMENTMALFUNCTION/INTERFERENCE—Donotusetheequipmentorsystem
adjacentto,orstackedwith,otherequipment.
Ifadjacentorstackeduseisnecessary,testtheequipmentorsystemtoverify
normaloperationinthecongurationinwhichyouareusingit.
WARNING:
ACCESSORIES/COMPONENTS—Addingaccessoriesorcomponents,ormodifying
themedicaldeviceorsystem,mayresultinincreasedEMISSIONSordecreased
IMMUNITYofthedeviceorsystem.
UsethefollowingresourcesformoreinformationonEMI/EMCandRFconcerns:
•TheSuppliesandAccessoriesReferenceGuideforyoursystem
•QualiedGEHealthcareorapprovedthird-partypersonnel
•TheElectromagneticCompatibilityappendixinyoursystemserviceoroperator’s
manual
Biocompatibility
Thepartsofthesystemdescribedinthismanualthatcomeintocontactwiththe
patientduringtheintendeduse,includingallaccessories,fulllthebiocompatibility
requirementsoftheapplicablestandards.Ifyouhavequestionsinthismatter,contact
yourGEHealthcarerepresentative.
LegalNotice
GEHealthcaresoftwarecontainsseveraleldsthatcanbelledinbeforeperforming
anECG.Someoftheseeldsarerequired,whileothersareoptionalandlefttothe
usertoassesswhethertheyareneededtoperformtheexam.TheeldRaceisone
oftheseoptionalelds.Racehasbeenacknowledgedbythemedicalprofessionas
usefultoanalyzesomepathologies.Youshouldbeawarethat,insomejurisdictions,
theprocessingofdatarevealinganindividual'sracialoriginissubjecttolegal
requirements,suchasobtainingthepatient'spriorconsent.Ifyouelecttocollectthis
typeofdata,itisyourresponsibilitytoensurethatyoucomplywithallapplicable
legalrequirements.
SuppliesandAccessories
YoushoulduseonlysuppliesandaccessoriesthatGEHealthcarerecommends.For
alistofrecommendations,refertothesuppliesandaccessoriesreferenceguide
forthissystem
ContactGEHealthcarebeforeusinganythingthatisnotrecommendedforthissystem.
2053535-003C
MAC™2000ECGAnalysisSystem
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