Device Dossier

Probe, pulse oximeter, reusable

Device Dossier for Probe, pulse oximeter, reusable (Probe, pulse oximeter, reusable, Class IIb, sponsor Lowenstein Medical). ARTG record, intended…

Intended purpose

Softtip SpO2 Sensors are accessory sensors used for continuous non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as accessories to The Prisma Ventilator which is used for ventilating patients with an independent respiratory drive. It can be used on patients who weigh over 10 kg and have respiratory insufficiency. It can be used in both stationary and mobile applications in both domestic and clinical environments.

TGA Public Summary