Intended Use
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.
Inspect the bag and device before use.
Do not use if the packaging is damaged or the protective caps are not housed in the designated locations, as sterility and/or performance may be compromised.
Do not use in case of detected impairment of the device integrity, as this could lead to potential causes of blood loss, treatment inefficiency or contamination of the user.
This device is intended to be used by personnel trained in dialysis treatments under supervision of a physician.
Select the appropriate type of dialyzer for the prescribed patient treatment to avoid performances different than those expected, such as lower removal of small-medium molecules, greater loss of proteins or blood loss due to treatment interruption.
High permeability dialyzers must only be used with dialysis machines that include ultrafiltration control to ensure prescribed patient weight loss during treatment.
Dialyzers must only be used with dialysis machines equipped with a blood leak detector to promptly identify blood in the dialysis fluid due to leaks or membrane deterioration.
Use the device only in accordance with the INTENDED USE.
Use the device in accordance with the conditions of use set out in PRECAUTIONS FOR USE.
Improper use of the device by the operator is under responsibility of the physician according to the operating procedures established in the hospital.
Use the device in accordance with the safety instructions of the machine manufacturer.
Use aseptic techniques during the entire period of device use to minimize the possibility of infection.
Keep the protective caps positioned on the inlet and outlet connectors of the blood compartment until the device is connected to the extracorporeal circuit.
Use the device with a frequency and duration of treatment according to medical prescription.
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.
It is recommended to use an air detector on the venous line during treatment.
If air is detected in the extracorporeal circuit, follow the intervention protocol of the dialysis department and the instructions provided by the manufacturer of the dialysis machine.
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 antithrombotic therapy is administered under medical supervision.
Using the device at high pressures can 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
This device contains polyethersulfone. Patients with a history of allergic reactions to polyethersulfone should not be treated with this device.
Side Effects
The dialysis treatment includes possible side effects such as hypotension, hypertension, headache, nausea, chills, fever, arrhythmia, cramps and thirst. In patients with these effects, the management of fluid balance must be handled with special care.
The known and expected side effects are anemia, blood loss, net fluid removal issue, acidosis.
Precautions For Use
All dialyzers of the Clearum™ HS family are subject to the following usage restrictions:
- Maximum blood flow: 500 ml/min;
- Maximum dialysate flow: 1000 ml/min;
- Maximum transmembrane pressure: 80 kPa (600 mmHg);
- Maximum blood compartment pressure: 105 kPa (800 mmHg);
- If inlet pressure monitoring is not available on the dialysis machine, visually check for abnormal increase of blood level in the arterial drip chamber.
It is recommended to follow the instructions for use of the dialyzer for rinsing and priming the device before use. After removing the protective caps, immediately connect the dialyzer to the extracorporeal circuit. During hemodiafiltration (HDF) or hemofiltration (HF) treatments in post-dilution with manual infusion management, it is recommended to keep the ultrafiltration flow rate within adequate values prescribed by the physician to prevent excessive blood concentration or blood coagulation in the extracorporeal circuit.
Removal of fluids from the patient must be monitored throughout the entire treatment session. It is recommended to use an anticoagulant during the treatment procedure. Type, dosage and method of anticoagulation must be prescribed by the physician.
The patient’s coagulation status should be monitored according to the hospital or clinic’s procedure.
Allergic reactions may occur during treatment.
Patient monitoring during treatment is essential when a history of allergic reactions is present. In case of suspected allergic reaction, it is recommended to stop the treatment. It is recommended not to reinfuse the blood in the extracorporeal circuit to the patient.
The device must be used strictly within the expiration date printed on the label and stored according to the storage instructions on the packaging. The expiration date refers to the product in undamaged packaging and stored at temperatures between 0°C and 30°C, avoiding direct exposure to the sun and vibrations. Otherwise, sterility, integrity and performances are not guaranteed, and the patient could therefore be exposed to ineffective treatment, infection or blood loss.
