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Warnings and Cautions
The following section contains a complete list of the major
warnings and cautions relevant to the ACT monitoring system.
These warnings and cautions are also repeated, as appropriate, in
sections of this manual. The prescribing physician is responsible
for reading and understanding all warnings and cautions prior to
prescribing the ACT monitoring system.
Warning
The ACT monitoring system is intended to be
used in conjunction with a monitoring service
that reviews the recorded transmissions and
provides that information to the physician for
his/her final diagnostic interpretation.
The ACT monitoring system is not intended for
use as an emergency medical response
system and should not be used by patients at
risk for serious or life-threatening cardiac
arrhythmias, such as ventricular tachycardia
and ventricular fibrillation. Refer to the
Physician Manual Specification for the types of
arrhythmias detected by the ACT monitoring
system.
The ACT monitoring system is not intended for
use in the diagnosis of myocardial infarction or
for chest pain monitoring.
Due to the risk of ignition or fire, the ACT
monitoring system is not intended for use in a
hyperbaric chamber, within an oxygen tent or
in the presence of flammable anesthetics /
medical gases.