1.4 Prescription Device StatementCAUTIONUnited States federal law restricts this device to sale by or on the order of a physician.1.5 Regulatory and Safety InformationThis section provides information about the safe use and regulatory compliance of this system.Familiarize yourself with this information, and read and understand all instructions before attemptingto use this system. The system software is considered medical software. As such, it was designed andmanufactured to the appropriate medical regulations and controls.NOTEDisregarding the safety information provided in this manual is considered abnormal use ofthis system and could result in injury, data loss, or a voided warranty.1.5.1 Safety ConventionsA Hazard is a source of potential injury to a person, property, or the system.This manual uses the terms DANGER, WARNING, CAUTION, and NOTICE to point out hazards and todesignate a degree or level of seriousness. Familiarize yourself with the following definitions and theirsignificance.Table 1-1 Definitions of Safety ConventionsSafety Convention DefinitionDANGER Indicates an imminent hazard, which, if not avoided, will result in death or serious injury.WARNING Indicates a potential hazard or unsafe practice, which, if not avoided, could result in death orserious injury.CAUTION Indicates a potential hazard or unsafe practice, which, if not avoided, could result in moderateor minor injury.NOTICE Indicates a potential hazard or unsafe practice, which, if not avoided, could result in the loss ordestruction of property or data.1.5.2 Safety HazardsThe following messages apply to the system as a whole. Specific messages may also be providedelsewhere in the manual.WARNINGEQUIPMENT MALFUNCTIONAny attempt by unauthorized personnel to service the device could result in equipmentmalfunction and void the warranty.This equipment contains no user-serviceable parts. Refer servicing to authorized servicepersonnel.Operator Manual 1.4 Prescription Device Statement2053535-002 Revision T MAC 2000 ECG Analysis System 12/198