VivaQuant Rhythm Express RX-1 mini Use Manual page 2

CAUTION: Carefully read all instructions prior to use. Observe all warnings and
cautions in these directions. Failure to do so may result in patient complications.
INTENDED USE
The Rhythm Express remote cardiac monitoring system is intended for use by patients
greater than 10 kg who either have or are at risk of having cardiac disease and those
that demonstrate intermittent symptoms indicative of cardiac disease and require
cardiac monitoring on a continuing basis. The device continuously records ECG data
and upon detection by an ECG analysis algorithm or manually initiated by the patient,
automatically delivers the recorded cardiac activity to the server where it is presented
for review by a medical professional.
The data received from the Rhythm Express device can be used by another device for
arrhythmia analysis, reporting and signal measurements. The Rhythm Express device
is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, provide interpretive or
diagnostic statements or provide for any life support. The Rhythm Express system
communicates events from the patient to the monitoring center within one to seven
minutes (assuming cell service is available) and hence is not suitable for use as a real-
time arrhythmia event monitor.
CONTRAINDICATIONS
1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
2. Patients who the attending physician thinks should be hospitalized.
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Rhythm Express® RX-1 mini Patient Use Guide LP-015 Rev J