Regulatory and Safety Information
Contraindications
This MAC 5 Resting ECG Analysis System is not intended in the manners below:
• During patient transport
• With high-frequency surgical units
• As an intra-cardiac application
• As a sole means of diagnosis
• As a vital signs physiological monitor
Clinical Benefits
The clinical benefits of the MAC 5 Resting ECG Analysis System include: analysis of
ECG data (QRS Complex) for diagnostic interpretation by the clinician/physician to
assist with clinical decision making in the care of patients with heart disease. These
clinical benefits follow the devices' intended uses and indications for use.
Prescription Device Statement
CAUTION:
United States federal law restricts this device to sale by or on the order of a
physician.
Safety Conventions
This section describes the safety conventions used in the documentation for the
product.
A Hazard is a source of potential injury to a person, property, or the system.
The manuals for this system use the terms DANGER, WARNING, CAUTION, and NOTICE
to point out hazards and to designate a degree or level of seriousness. Familiarize
yourself with the definitions below and their significance.
Table 128: Definitions of Safety Conventions
Safety Convention Description
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.
CAUTION Indicates a potential hazard or unsafe practice, which, if not avoided, could
result in moderate or minor injury.
340  MAC
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5 A4/MAC
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5 A5/MAC
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5 Lite 5864335-001-1
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