Device Dossier
Single-patient physiologic monitoring system
Device Dossier for Single-patient physiologic monitoring system (Single-patient physiologic monitoring system, Class IIb, sponsor Draeger). ARTG record,…
- GMDN category: Single-patient physiologic monitoring system
Intended purpose
The monitor is intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitor is intended for use by trained healthcare professionals in hospital environments. Monitoring parameters include: NIBP (Non-Invasive Blood Pressure), SpO2 (functional arterial oxygen saturation), PR (Pulse Rate), TEMP (Temperature), CO2 (Carbon Dioxide) and RR (Respiration Rate).