Indications for use

Intended Use

The Clearum™ HS dialyzer family is intended for use in acute or chronic renal failure patients requiring hemodialysis.

Warnings

The dialyzer is designed for single patient use only. Do not reuse, resterilize, or reprocess the device as this may compromise structural integrity, sterility or expected performances of the device and create a risk of contamination which could result in adverse patient reactions.

Use the device with a frequency and duration of treatment according to medical prescription.

Dialyzers must only be used with dialysis machines equipped with a blood leak detector.  High permeability dialyzers must only be used with dialysis machines that include ultrafiltration control.

The presence of air in the extracorporeal circuit can cause embolism. Implement the appropriate clinical procedures to remove air before connecting the patient for treatment.

Blood circulation through the dialyzer membrane can cause blood clots resulting in partial or total occlusion of the fibers with thrombus onset. 

It is recommended that appropriate anticoagulant therapy is administered under medical supervision.

Using the device at high pressures might push the dialysis fluid into the bloodstream. To minimize exposure of blood to bacteria or endotoxins, monitoring of water and dialysis fluid quality according to the reference standards is recommended.

Contraindications and Side Effects

Allergic reactions might occur during treatment. This device contains polyethersulfone. Patients with a history of allergic reactions to polyethersulfone  should not be treated with this device.  If allergic reaction is suspected, stop the treatment and do not reinfuse the blood to the patient.

The dialysis treatment includes possible side effects such as hypotension, hypertension, nausea, chills, and cramps.  In patients with these effects, the management of fluid balance must be handled with special care.