INTENDED USE AND PATIENT POPULATION
The Centeze® is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For use on both adult and adolescent groups.
CONTRAINDICATIONS
- Where percutaneous drainage catheterization is unacceptable
- Bleeding diathesis and uncontrolled hypertension
- Anticoagulant use
- Chemical ablation of tissue
WARNINGS
• The Centeze® is supplied sterile for single use only.
• Do not exceed insertion dwell time of 24 hours.
• Do not alter this device in any way.
• Do not resterilize the device. Re-sterilization could change the physical characteristics of the materials and should not be attempted.
• Do not reuse the device. Reuse will result in increased biocontamination risk for the patient resulting in infection or pyrogenic response.
• During insertion avoid contact with bone, cartilage and scar tissue, which can damage the needle and catheter tip.
PRECAUTIONS
The Centeze® deployment procedure should be performed by physicians thoroughly trained in drainage techniques and procedures.
Do not use the Centeze® if the packaging is damaged.
Inspect the Centeze® prior to use for any bends or kinks. Do not use a damaged needle because trauma to the patient and/or inability to place the drainage catheter may occur. Any serious incident in relation to this device should be reported to the manufacturer and the competent authority established in the user and/or patient’s Member State. COMPLICATIONS: These are generally associated with drainag
