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…

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.

TGA Public Summary