Device Dossier
Probe, pulse oximeter, reusable
Device Dossier for Probe, pulse oximeter, reusable (Probe, pulse oximeter, reusable, Class IIb, sponsor Emu Medical Group). ARTG record, intended…
- GMDN category: Probe, pulse oximeter, reusable
Intended purpose
Provide continuous, non-invasive arterial oxygen saturation and pulse rate monitoring are required. A photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays SpO2 values. Areas of use include Operating Room, Intensive Care Unit, Emergency Department, Recovery Room and Doctors' Offices and for the treatment of patients in and out of a hospital, as well as during transport. This is a reusable device.