GE MAC 600 - Biocompatibility; Responsibility of the Manufacturer; General Information; Recording Ecgs During Defibrillation

Introduction
Biocompatibility
Thepartsoftheproductdescribedinthismanual,includingallaccessoriesthatareintendedto
comeincontactwiththepatientduringtheintendeduse,fulllthebiocompatibilityrequirementsof
theapplicablestandards.PleasecontactGEHealthcareoritsrepresentativeswithanyquestions.
ResponsibilityoftheManufacturer
GEHealthcareisresponsiblefortheeffectsofsafety,reliabilityandperformanceonlyif:
lAssemblyoperations,extensions,readjustments,modications,orrepairsarecarriedoutby
personsauthorizedbyGEHealthcare.
lTheelectricalinstallationoftherelevantroomcomplieswiththerequirementsoftheappropriate
regulations.
lTheequipmentisusedinaccordancewiththeinstructionsforuse.
GeneralInformation
RecordingECGsduringDebrillation
Thisequipmentisprotectedagainsttheeffectsofcardiacdebrillatordischargetoensure
recovery,asrequiredbyteststandards.
Thepatientsignalinputoftheacquisitionmoduleisdebrillation-proof.Therefore,itisnot
necessarytoremovetheECGelectrodespriortodebrillation.
Whenusingstainlesssteelorsilverelectrodes,adebrillatordischargecurrentmaycausethe
electrodestoretainaresidualchargecausingapolarizationorDCoffsetvoltage.Thiselectrode
polarizationwillblockacquisitionoftheECGsignal.Toavoidthiscondition,usenon-polarizing
electrodes(whichwillnotformaDCoffsetvoltagewhensubjectedtoaDCcurrent)suchas
silver/silver-chloridetypes,ifthereisasituationwherethereisalikelihoodthatadebrillation
procedurewillbenecessary.
Ifpolarizingelectrodesareused,werecommenddisconnectingtheleadwiresfromthepatient
beforedeliveringtheshock.
2047426-001KMAC™60023