Indications For Use

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Refer to the Instructions for Use for complete instructions for use.

Indications

The VAXCEL Implantable Port System is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawl of venous blood samples.

Contraindications

The VAXCEL Port is contraindicated for patient use under the following conditions:

• Presence or suspicion of allergic reaction to materials contained in this device
• Presence or suspicion of infection, bacteremia, septicemia, or peritonitis
• Demonstrated intolerance of an implanted device
• Body size insufficient to accommodate size of portal or catheter

Warning

For single 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 cross-infection, including, but not limited, to transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Potential Adverse Effects

Although the VAXCEL Implantable Port System has been engineered for optimal safety, there are inherent risks associated with any implantable device. These include the following:

• Implant rejection
• Implant rotation or extrusion
• Catheter occlusion, malposition, dislodgment or disconnection, fibrin sheath formation at tip; rupture
• Catheter occlusion or breakage caused by pinching between clavicle and first rib
• Sepsis; pneumothorax, hemothorax, or hydrothorax; perforation or laceration of vessels or viscus; abdominal hernia; thrombosis, thromboembolism; cardiac arrhythmia, endocarditis, cardiac tamponade; brachial plexus injury; peritoneal leakage, and peritonitis

Use of the VAXCEL Port Systems involve risks normally associated with the insertion or use of any implanted device or indwelling catheter.

• Implant Rejection
• Catheter disconnection or fracture
• Infection
• Catheter thrombosis
• Catheter Occlusion
• Catheter shear or migration and extravasation

Cautions

• Site Preparation: Always observe aseptic technique when performing vascular access.
• Syringes: Use 10mL or larger volume syringes for all system procedures. The smaller the syringe volume the higher the pressure that can be generated. Do not exceed 40 psi.
• Needles: Use only non-coring needles to access the system.
• NEEDLES ARE SINGLE USE ONLY.
• Needle Gauge: To preserve septum integrity use the smallest non-coring needle possible for the application. NOTE: Use only 20-22 gauge needles when accessing the VAXCEL Mini port system.
• Needle Insertion: Always access the system with the needle perpendicular to the implanted port. Insert the needle tip fully through the septum until the needle makes contact with the needle stop. Incomplete insertion may result in needle obstruction by the septum. While the needle is in place do not leave the system open to air. Always close clamps or stopcocks proximal to the VAXCEL Port before changing syringes or tubing sets.
• Drug Administration: Review all drug labeling prior to drug administration. There are some medications which become unstable in the presence of heparin.
• Saline Flushes: Prior to drug administration, flush the system with normal saline solution to remove heparin. If more than one drug is administered, between drugs flush the system with normal saline solution. After patient therapy is completed ALWAYS flush the system to cleanse the catheter and port chamber. Follow with a “Heparin-Lock”.