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Introduction
Intended Use
ACT III –CG 6108
The ACT III Continuous ECG Monitor and Arrhythmia Detector is
intended for use by patients who experience transient symptoms
that may suggest cardiac arrhythmia. The device continuously
monitors patient ECG, automatically generates an alarm triggered
by an arrhythmia detection algorithm, or generates an alarm
manually triggered by the patient, and transmits the recorded data
trans-telephonically to a monitoring center. The monitoring center
provides the ECG data to the medical practitioner for evaluation.
The ACT monitoring system is intended to be prescribed for
patients who have demonstrated a need for cardiac monitoring
and are at low risk of developing life-threatening
arrhythmias. Conditions where the system should
not
be used
include patients likely to experience primary Ventricular Fibrillation
or Ventricular Tachycardia and patients who have other co-morbid
cardiovascular conditions where an arrhythmia could be
potentially life threatening.
The device has not been tested for and it is not intended for
pediatric use.
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 monitoring system is not intended
for use as an emergency response system for patients who may
experience life-threatening arrhythmias.
Sensor
Cellular phone