Page 41
Notes
The ACT monitoring system has been
tested and found to comply with the
limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules.
These limits are designed to provide
reasonable protection against harmful
interference when the equipment is
operated in a commercial environment.
The ACT monitoring system is designed
to detect the arrhythmias listed in the
specification section above. Due to the
potential variability in ECG signals due
to device, patient, and environmental
factors, the ACT monitoring system
cannot detect the specified arrhythmias
under all conditions. Additional
information on the sensitivity and
specificity of the ACT monitoring system
for particular arrhythmias is available
from LifeWatch upon request.