Indications, Safety and Warnings
Indications for Use
The BodyGuardian Verité is intended for acquiring ambulatory ECG signals from patients who either are at risk of having cardiac disease or have intermittent symptoms indicative of cardiac disease and who have demonstrated a need to be monitored on a continuing basis.
Indications for conducting ambulatory recording include:
- Patients requiring monitoring for non-life-threatening arrhythmias such as supraventricular tachycardia and ventricular ectopy.
- Patients requiring monitoring for evaluation of Brady arrhythmias and intermittent bundle branch block including after cardiovascular surgery and myocardial infarction.
- Patients requiring monitoring for arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
- Patients experiencing symptoms such as a) syncope of unknown etiology or b) shortness of breath which may be due to cardiac arrhythmias.
- Patients with palpitations with or without known arrhythmias to obtain correlation of arrhythmias with symptoms.
- Patients who require monitoring of the effects of drugs to control ventricular rate in atrial arrhythmias.
- Patients recovering from cardiac surgery that are indicated for outpatient arrhythmia monitoring.
- Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive central) to evaluate possible nocturnal arrhythmias.
- Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or flutter.
Data from this device may be used by another device to analyze, measure, or report QT interval. The device is not intended to sound any alarms for QT interval changes.
- Single patient Use
- Do not dispose
- Do not use if broken /damaged
- Do not disassemble
The BodyGuardian Verité is not intended for use under the following conditions:
- Infants weighing less than 10 kg. (22 lbs.).
- Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
- Patients who the attending physician thinks should be hospitalized.