Neonatal/paediatric heart rate monitoring application software

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Device Technologies Australia Pty Ltd

Class:

Class IIb

Manufactured by:

Medical Predictive Science Corporation 1233 Cedars Court Suite 201, Charlottesville, VA, 22903 United States Of America

Therapeutic area:

58703 - Neonatal/paediatric heart rate monitoring application software

Therapeutic indications:

HeRO is intended to acquire, store, analyze, and report on ECG data collected from infants. HeRO is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment. HeRO is intended to be used for the analysis of the variability in RR Intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HeRO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate. HeRO is intended to provide specialized HRV measurements and may detect arrhythmias, that when combined with other risk factors, can be used as an aid in assessing the risk of sepsis in infants. The use of the HeRO monitoring improves survival in very low birth weight neonates.

Authorization status:

A

Authorization date:

2015-08-25