Device Dossier
Wearable multiple vital physiological parameter monitor
Device Dossier for Wearable multiple vital physiological parameter monitor (Wearable multiple vital physiological parameter monitor, Class IIb, sponsor…
- GMDN category: Wearable multiple vital physiological parameter monitor
- Sponsor: GE Healthcare
Intended purpose
The Portrait Mobile Patient Monitor (Portrait HUB01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from Portrait wearable sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The Portrait Mobile Patient Monitor can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services. The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment.