Device Dossier

oXiris Set - Haemofilter

Device Dossier for oXiris Set - Haemofilter (Haemofilter, Class III, sponsor Vantive). ARTG record, intended purpose, GMDN category — compiled by…

Intended purpose

The oXiris set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.

Functional description

Patient blood travels via set tubing circuit, through the haemodialyser, returning via set tubing to patient. In the dialyser it flows through hollow heparin-coated fibers where, by means of hydrostatic or transmembrane pressure, plasma water and certain lower and middle molecular weight solutes pass through the membrane into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the blood by both diffusion and convection through the membrane

TGA Public Summary