GE MAC 2000 - Page 22

Introduction
indicateacaution.Familiaritywiththesesymbolsassistsintheuseanddisposal
oftheequipment.
Forequipmentsymbolsnotshown,refertotheoriginalequipmentmanufacturer
(OEM)manuals.
SymbolDescriptions
Symbol
Description
CatalogorOrderablePartNumber
Indicatesthemanufacturer'scatalogorpartnumber.
SerialNumber
Indicatesthemanufacturer'sserialnumber.
BatchCodeorLotNumber
Indicatesthemanufacturer'sbatchcodeorlotnumber.
DateofManufacture(Year-Month)
Indicatestheoriginalmanufacturedateforthisdevice.
Manufacturer
Indicatesthenameandaddressforthemanufacturerofthisdevice.It
mayalsoincludethedateitwasmanufactured.
AuthorizedRepresentativeintheEuropeanCommunity
Indicatesthenameandaddressoftheauthorizedrepresentativeinthe
EuropeanCommunityforthisdevice.
RxOnly
USFederallawrestrictsthisdevicetosalebyorontheorderofa
physician.
12SL
IndicatesthedeviceusestheMarquette™12SLECGAnalysisProgram
toanalyzeandinterpretECGreadings.
IPxy
IPCode(IngressProtectionRating)
Classiesandratesthedegreeofprotectionprovidedagainstthe
intrusionofsolidobjects(suchasbodypartslikehandsandngers,
dust,accidentalcontact),andliquids.
Therstnumeral(x)representsthedegreeofprotectionagainstthe
ingressofsolidobjects.
Thesecondnumeral(y)representsthedegreeofprotectionagainstthe
ingressofliquids.
ForproductswithanIPxyrating,seetheClassicationofMedicalDevice
inthischapterforadescriptionofthatrating.Notallproductshave
anIPxyrating.
ClassIIEquipment
Identiesequipmentthatmeetsthesafetyrequirementsspeciedfor
classIIequipmentbyIEC60601–1.
Thisdevicewasdesignedsothatitdoesnotrequireasafetyconnection
toelectricalearth(USground).Nosinglefailureresultsindangerous
voltagebecomingexposedandcausinganelectricshock.Thisis
achievedwithoutrelyingonanearthedmetalcasing.
22
MAC™2000ECGAnalysisSystem
2053535-003C