INDICATIONS FOR USE
The One-Step Centesis Catheter is indicated for the percutaneous drainage of fluids.
CONTRAINDICATIONS None known.
Warning:
Do not re-attach distal obturator to needle.
Insert catheter into fluid collection site using standard insertion technique.
When catheter is in appropriate position, remove needle from catheter.
Warning:
Do not reinsert needle into catheter while the catheter is still in the patient.
Attach a device with a standard Luer fitting to catheter hub to remove fluid.
Following the procedure, gently withdraw the catheter and dress the site accordingly
PRECAUTIONS
• Read manufacturer’s instructions prior to use
• Caution: Federal (USA) law restricts this device to sale by or on the order of a physician trained and/or experienced in the use of the device.
• Contents of unopened, undamaged package are sterile.
• Do not leave in patient longer than 24 hours.
• Store in a cool, dry place.
• Do not use if packaging is damaged.
• Inspect the device prior to use to verify that no damage has occured during shipping.
• Do not use after expiration date
• For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.