GE MAC 1600 - Introduction

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Introduction
Thischapterprovidesgeneralinformationrequiredfortheproperuseoftheproduct
andthemanual.Familiarizeyourselfwiththisinformationbeforeusingtheproduct.
IntendedUser
Theintendeduserofthistechnicalinformationisservicerepresentativesandtechnical
personnelsotheycanmaintaintheequipmenttotheassemblylevel.
IndicationsforUse
TheintendeduseofthisdeviceistorecordECGsignalsfromsurfaceECGelectrodes.
Thisdevicecananalyze,record,andstoreelectrocardiographicinformationfromadult
andpediatricpopulations.Thisdatacanthenbecomputeranalyzedwithvarious
algorithmssuchasinterpretiveECGandsignalaveragingforpresentationtotheuser.
Thisdeviceisintendedforuseunderthedirectsupervisionofalicensedhealthcare
practitioner.
Contraindications
TheMAC1600deviceisNOTintended:
•tobeusedduringpatienttransport,
•tobeusedforintra-cardiacapplications,
•tobeusedasavitalsignsphysiologicalmonitor,or
•toprovidealarmsforArrhythmiadetection.
TheArrhythmiadetectionmodeisprovidedfortheconvenienceofautomatic
documentation.
PrescriptionDeviceStatement
CAUTION:
UnitedStatesfederallawrestrictsthisdevicetosalebyorontheorderofa
physician.
2028451-183EMAC™1600
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