Device Dossier

Patient monitor, central unit

Device Dossier for Patient monitor, central unit (Patient monitor, central unit, Class IIb, sponsor GE Healthcare). ARTG record, intended purpose, GMDN…

Intended purpose

The CARESCAPE Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect, display and print information from a network, including patient demographics, physiological parameters and waveforms, alarm annunciation and/or other non-medical information from monitors and telemetry systems. Physiological parameters and waveforms include electrocardiograph (ECG), pulse oximetry (SPO2), invasive blood pressures (IBP), non-invasive blood pressure (NIBP), respiration (RR), ventilator (VNT), carbon dioxide (CO2), oxygen (O2), mass spectrometry (Gas), temperature (Temp) and bispectral index (BIS). Beat to beat patient information for parameters and waveforms from the bedside and telemetry systems can be displayed. Patient monitor and telemetry system settings can be adjusted. Parameter values derived from patient data can be calculated, displayed, and printed. The CARESCAPE Central Station supports the ability to access information from GE products and hospital intranet in a web browser format. Additionally, CARESCAPE Central Station supports the ability to access patient information collected from the CARESCAPE network.

TGA Public Summary