Computer, cardiac catheterization laboratory

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Klasse:

Class IIb

Produsert av:

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

Terapeutisk område:

10980 - Computer, cardiac catheterization laboratory

Indikasjoner:

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.

Autorisasjon status:

A

Autorisasjon dato:

2019-08-21