Contents
1Introduction
IntendedUserofthisProduct...................................................................13
IndicationsforUse....................................................................................13
Contraindications.....................................................................................14
PrescriptionDeviceStatement.................................................................14
RegulatoryandSafetyInformation...........................................................14
SafetyConventions..................................................................................14
SafetyHazards........................................................................................15
ClassicationofMedicalDevice...................................................................17
CerticationInformation............................................................................17
RecordingECGsDuringDebrillation.............................................................17
AccuracyofInputSignalReproduction...........................................................18
ModulatingEffectsinDigitalSystems............................................................18
EMI/EMC/RFSafetyInformation...................................................................18
Biocompatibility.......................................................................................19
LegalNotice...........................................................................................19
SuppliesandAccessories...........................................................................19
ResponsibilityoftheManufacturer................................................................20
ResponsibilityofthePurchaser/Customer.......................................................20
ProductandPackagingInformation..............................................................20
Training.................................................................................................28
EquipmentIdentication...........................................................................28
ProductLabel.........................................................................................29
SerialNumberFormat...............................................................................29
DeviceAddressLabelandRatingPlate...........................................................30
ProductCodes........................................................................................30
ServiceInformation...................................................................................31
ServiceRequirements...............................................................................31
WarrantyInformation...............................................................................31
AdditionalAssistance................................................................................31
ManualInformation..................................................................................31
ManualPurpose......................................................................................31
DocumentConventions.............................................................................31
2ProductOverview
ProductDescription..................................................................................33
HardwareOverview..................................................................................33
FrontView.............................................................................................34
RearView..............................................................................................34
SideView...............................................................................................35
InternalView..........................................................................................36
2053535-003C
MACâ„¢2000ECGAnalysisSystem
9