GE HEALTHCARE MAC 2000, Operator'S Manual

Page: 10 / 226

Introduction
Arrhythmia detection is provided for the convenience of automatic documentation.
Transmission and reception of ECG data to and from a central ECG cardiovascular
information system is optional.
Contraindications
This system is not intended for use in the following manner:
• During patient transport
• With high-frequency surgical units
• As an intra-cardiac application
• As a vital signs physiological monitor
Prescription Device Statement
CAUTION:
United States federal law restricts this device to sale by or on the order of a
physician.
Regulatory and Safety Information
This 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 attempting to use this system. The system software is considered
medical software. As such, it was designed and manufactured to the appropriate
medical regulations and controls.
NOTE:
Disregarding the safety information provided in this manual is considered
abnormal use of this system and could result in injury, data loss, or a voided
warranty.
Safety Conventions
A 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 to designate a degree or level of seriousness. Familiarize yourself with
the following definitions and their significance.
Definitions of Safety Conventions
Safety
Convention Definition
DANGER
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 or serious injury.
10 MAC™ 2000 2053535-002K