Computer, cardiac catheterization laboratory

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Commercializzato da:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Classe:

Class IIb

Prodotto da:

Change Healthcare Canada Company 10711 Cambie Road, Richmond, BC, V6X 3G5 Canada

Area terapeutica:

10980 - Computer, cardiac catheterization laboratory

Indicazioni terapeutiche:

The device is intended for complete physiological/ hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. The device is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. The device is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed. User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended for unattended patient monitoring or in situations where arrhythmia detection is required.

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2019-08-21