RhythMedix RhythmStar - Indications for Use; Contraindications for Use

Revison 0.8.6 Document No. 01424
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2. Indications for Use
The
RhythmStar System is intended for use by patients 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 and can be reviewed by a
medical professional.
The data received from RhythmStar device can be used by another device for
arrhythmia analysis, reporting and signal measurements. The RhythmStar system 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. RhythmStar is for prescription
use only (Part 21 CFR 801 Subpart D).
3. Contraindications for Use
The RhythmStar system is
not intended for use under the following conditions:
 Patients with potentially life-threatening arrhythmias who require inpatient
monitoring.
 Patents who the attending physician believes should be hospitalized.
 Infants weighing less than 10 kg. (22 lbs.).