Filter, apheresis

Intended purpose

The PRISMAFLEX TPE 1000 and TPE 2000 set are indicated for use only with the PRISMAFLEX control unit or with the PRISMAX control unit, after having selected the TPE therapy (therapeutic plasma exchange). The PRISMAFLEX TPE1000 and TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components is indicated. The use of the PRIMSMAFLEX TPE 1000 set should be restricted to patients with a body weight greater than 9 kg (20lbs). The use of the PRISMAFLEX TPE 2000 set should be restricted to adults. The size, weight, state of uraemia, cardiac status and general physical condition of the patient must be evaluated by the prescribing physician before each treatment. The device should be used only on the direction of a physician who has evaluated all the pertinent features of this device in relation to the individual patient. Patients with bleeding tendencies must be closely supervised during the treatment. The treatment should be discontinued if acute haemorrhage that can not be corrected (haematemesis, haemoptysis and melaena) occurs during TPE. All treatments administered via the PRISMAFLEX set must be prescribed by a physician.