RootiCare System - Electrocardiograph, Holter analyser, software

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Loop Healthcare Pty Ltd

Klasse:

Class IIa

Fremstillet af:

Rooti Labs Ltd 5F-1 No 71 Zhouzi Street, Neihu District, Taipei City, 11493 Taiwan

Terapeutisk område:

41651 - Electrocardiograph, Holter analyser, software

Terapeutiske indikationer:

RootiCare system is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from RootiRx. RootiCare includes an algorithm that will analyze single lead ECG and produce measurements of the ECG recording as well as textual interpretation. RootiCare system will be accessed over internet and data will be stored at the RootiCare data warehouse. Data will be secure, and with separate data stores for each client. Users will be able to access specific modules for managing patient cardiac related data such as arrhythmia data that fit their patients' needs. RootiCare is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. RootiCare does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

Autorisation status:

A

Autorisation dato:

2022-01-05