Device Dossier
Pulse oximeter probe/processor
Device Dossier for Pulse oximeter probe/processor (Pulse oximeter probe/processor, Class IIb, sponsor GE Healthcare). ARTG record, intended purpose, GMDN…
- GMDN category: Pulse oximeter probe/processor
- Sponsor: GE Healthcare
Intended purpose
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Pulse Oximetry Sensor 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 Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.