Interpretive multichannel electrocardiograph

Intended purpose

The ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations. The system provides 12-lead ECG and interpretive analysis. The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information. The ECG Analysis System is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner. The ECG Analysis System may be used with optional spirometer handle to perform spirometry diagnostic tests in adult and pediatric patients aged 5 years and older.