Cardiac Navigator with Faros - Cardiac electrophysiology application software
Access comprehensive regulatory information for Cardiac Navigator with Faros - Cardiac electrophysiology application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Cloudholter Pty Ltd, manufactured by Bittium Biosignals Ltd in Finland. The device registration started on May 03, 2022.
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Bittium Cardiac Navigator is intended for the analysis of data pre-recorded on Bittium Faros series ambulatory ECG devices. In addition, Cardiac Navigator software can display and analyse rest and stress ECG data. The Cardiac Navigator is intended for analysing, editing, reviewing, reporting, and storing of pre-recorded ambulatory EGG and accelerometer data on Bittium Faros series ambulatory ECG devices. The results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. Cardiac Navigator is intended to be used by trained operators and licensed healthcare practitioner in a hospital or clinic environment. Cardiac Navigator is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm, and arrhythmia. This procedure is known as a Holter procedure and captures infrequent or activity provoked ECG rhythm abnormalities inside or outside hospital or clinical environment. Bittium Cardiac Navigator analyses are not intended for infants weighing less than 10 Kg (22 lbs). Bittium Cardiac Navigator comprises Bittium Faros ambulatory ECG sensors and Bittium Cardiac Navigator Software. As the patient wears the ambulatory ECG sensor, it records ECG data. The Cardiac Navigator application analyses the recorded data. Bittium Faros series sensors provide signal acquisition patient ECG waveforms through skin surface electrodes adhered to the body. In addition to patient ECG waveforms, Bittium Faros devices allow measuring physical activity with devices’ in-built 3-axis accelerometer.