GE MAC 2000 - Intended User of this Product; Indications for Use

1
Introduction
ThisdocumentdescribestheMAC™2000ECGAnalysisSystem,alsoreferredtoasthe
“product”,“system”,or“device”.Thedocumentisintendedtobeusedbyanyonewho
maintainsortroubleshootsthisequipment.
Thischapterprovidesgeneralinformationrequiredfortheproperuseofthesystem
andthismanual.Familiarizeyourselfwiththisinformationbeforeusingthesystem.
IntendedUserofthisProduct
TheMAC™2000ECGAnalysisSystemisaportableECGacquisition,analysis,and
recordingsystemthatisintendedforusebytrainedoperatorsinahospitalormedical
professional’sfacilityenvironment,aswellasusedinclinics,physicianofces,
outreachcenters,orwhereverECGtestingisperformed.
IndicationsforUse
TheMAC™2000ECGAnalysisSystemisaportabledeviceintendedtobeusedby
orunderthedirectsupervisionofalicensedhealthcarepractitionerusingsurface
electrodestoacquire,analyze,display,andrecordinformationforadultandpediatric
populationsinahospital,medicalprofessional’sfacility,clinics,physician’sofceor
outreachcenters.
NOTE:
Pediatricpopulationsaredenedaspatientsbetweentheagesof0and15years.
TheMAC™2000ECGAnalysisSystemprovidesthefollowingmodesofoperation:
•RestingECGmode
•Arrhythmiamode
•Exercisemodeforexercisestresstesting(optional)
•RRanalysismodeforRRintervalanalysis(optional)
Thebasicsystemprints6or12leadsofECGandisupgradeabletoprovidesoftware
optionssuchas12-leadECGmeasurementandinterpretiveanalysis.
Arrhythmiadetectionisprovidedfortheconvenienceofautomaticdocumentation.
TransmissionandreceptionofECGdatatoandfromacentralECGcardiovascular
informationsystemisoptional.
2053535-003C
MAC™2000ECGAnalysisSystem
13