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
Vista 300: The monitors are 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 monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic Gas (AG), bispectral indexTM (BIS), neuromuscular transmission (NMT). The monitors are not intended for MRI environments. Vista 300 S: The monitors are 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 monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.) (for adults only), anesthetic Gas (AG). The monitors are not intended for MRI environments