User's Manual
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10. Patients requiring measurement of ST segment changes. The device is not intended to
sound any alarms for ST segment changes.
11. The device is intended to identify Cyclic Variation of Heart Rate (CVHR) pattern to
evaluate need of further testing for sleep disorders
FOR USE ON ALL PATIENTS
The CardioNet MCOT system is intended for use on adults, children and infants weighing less
than 22 pounds.
Contraindications for use:
1. Patients with potentially life-threatening arrhythmias who require inpatient Monitoring.
2. Patients who the attending physician recommends should be hospitalized for ECG
monitoring.
3. This device should not be used for monitoring of QT interval during the initiation of
antiarrhythmic therapy, where in-hospital monitoring is required by the labeling of
that drug.
4. The device does not replace the QT interval measurement by a trained observer
using diagnostic 12 lead ECG in a clinical environment. This device is not intended
to sound any alarms for QT interval changes.
5. The device does not annotate QT interval for QRS durations >160 ms or for T wave
amplitudes ≤5% of the peak QRS amplitude.