Device Dossier

Patient monitor, central unit

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

Intended purpose

The Infinity CentralStation (ICS) is intended for use by trained health care professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation. Infinity CentralStation with Rest ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

TGA Public Summary