Device Dossier

Patient monitor module, multifunction

Device Dossier for Patient monitor module, multifunction (Patient monitor module, multifunction, Class IIb, sponsor GE Healthcare). ARTG record, intended…

Intended purpose

The CARESCAPE PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the CARESCAPE PDM includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to monitoring devices for viewing and alarm surveillance purposes.

TGA Public Summary