Smart Monitor KC911 - Telemetry system, physiological signal

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Microport Crm Pty Ltd

classe:

Class III

Fabriqué par:

MicroPort CRM S.r.l Via Crescentino sn, Saluggia, VC, 13040 Italy

Domaine thérapeutique:

32547 - Telemetry system, physiological signal

indications thérapeutiques:

The Smart Monitor is a radio frequency wireless monitor that collects clinical information and device parameters. The data is retrieved by the portable external monitor from an implanted cardiac device and routed through the cellular network, converted to a format that can be reported to the physician. 2 RF bands are used : ISM band (2.45 GHz) and MICS (402-405 MHz) band for data transfer. The device includes Smart Monitor, user manual, silicon sleeve, power supply and power adaptor. The Smart Monitor is designed for use with the MicroPort radio frequency implanted cardiac defibrillator specifically to transmit information stored in the implanted cardiac device to the physician. It is intended to perform the following tasks: - Collect data from Microport Implanted Cardiac Device using Radio- Frequency telemetry. 2 RF bands are used : a. ISM band (2.45 GHz) for communication initialization (ICD wake-up) b. MICS (402-405 MHz) band for data transfer - Transfer collected data to the Back Office (data management system) through GSM (Global System for Mobile) on periodical or alert events basis. It is indicated for the remote follow up of patients who are implanted with a MicroPort radio frequency defibrillator according to the applicable Medical Guidelines (2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.)

Statut de autorisation:

A

Date de l'autorisation:

2020-12-04