Device Dossier
Pulse oximeter, battery-powered
Device Dossier for Pulse oximeter, battery-powered (Pulse oximeter, battery-powered, Class IIa, sponsor Digital Sleep Devices). ARTG record, intended…
- GMDN category: Pulse oximeter, battery-powered
Intended purpose
An electrically-powered photoelectric device designed for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) and pulse rate. The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. It is applied to the fingertip or around the wrist and wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.