INDICATIONS
The TITAN-PORT-Systems ensure repeated access to the vascular system for the following indications:

• Long-term treatment with cytostatic agents and other "aggressive" medications
• Regional chemotherapeutic treatment of liver tumors, metastases, tumors of the head and extremities, and tumors of other organs
• Patients with poor peripheral veins requiring frequent intravenous injections
• Infusion therapy and parenteral nutrition
• HIV patients
• Venous blood sampling for blood transfusions * See note In addition, the systems may be used for the following indications: TITAN-PORT A (arterial) is employed primarily for the direct perfusion of organs, for inoperable hepatic metastases via the gastroduodenal artery, via the coeliac trunk for pancreatic and via the aorta and internal iliac arteries for pelvic neoplasms.

TITAN-PORT D for dialysis venous <-> venous
TITAN-PORT PD for peritoneal dialysis
TITAN-PORT PC for peritoneal chemotherapy
TITAN-PORT S for peridural pain therapy or anesthesia

CONTRAINDICATIONS
The TITAN-PORT systems should not be used in:

• Extremely rare cases of hypersensitivity to silicone, polyurethane or titanium
• suspected bacteremia or sepsis
• disseminated intravascular coagulation (DIC)

COMPLICATIONS and potential ADVERSE REACTIONS
The following complications or adverse reactions can occur:

• Technical intraoperative complications
• Tissue incompatibility
• Local reactions (inflammation, edema, hematoma)
• Infection
• Disconnection or dislocation
• Thrombosis / thromboembolism
• Breakage of the catheter between the clavicle and first rib
• Breakage of catheter or damage to catheter
• Membrane leakage
• Perforation of catheter
• Drug extravasation due to improper handling of the system
• Damage to neighboring tissues by the pharmaceutical agents
  (In the event of leakage of portal components)

INSTRUCTIONS FOR USE / PORT IMPLANTATION
Caution: During implantation sterile handling is absolutely mandatory!

• Various techniques are available for implantation of port and catheter, including the Seldinger technique

The choice depends on the surgeon's preference

• The implantation of TITAN-PORT A/V, P and S is usually possible under local anesthesia, TITAN-PORT D, PD, PC under general anesthesia (see special instructions for use)
• Recommended sites for venous catheter placement include the cephalic vein, subclavian vein, or internal and external jugular veins.
• Use a 10 ml syringe and only special non-coring needles for puncturing the septum. The needles are intended for single use only.
• The needle should be inserted into the silicon membrane carefully and always vertically to avoid bending the tip.

If the situation is unclear or thrombotic obstruction is suspected a radiographic or Doppler sonographic control is necessary. To achieve greater flow rates the port membrane may be accessed simultaneously with up to three needles.

• A venous implantation should be flushed with 10 ml heparin/saline solution (200 IU heparin in 10 ml 0.9% saline) once every 3-4 weeks
• An arterial implantation requires flushing once every 2 week.
• For sampling venous blood 3 ml of blood should initially be aspirated and discarded. A 20 G needle should be used and the required amount of blood aspirated slowly to avoid haemolysis and falsification of the results. *Note: 18 G or 19 G needle is recommended for blood transfusions.
  Afterwards the system must be flushed immediately with a heparinized saline solution. During the flushing procedure the needle may be rotated in different directions to ensure uniform rinsing of the chamber interior.
• To avoid interactions between various drugs (cytostatic agents in particular) the system must be flushed with 5-10 ml 0.9% saline when repeated infusions are required.
• The system must be flushed after each use. The needle is removed with gentle force.
• Catheter obstruction due to thrombus formation can usually be cleared by injecting Streptokinase / Urokinase (e.g. 5000 IE / ml physiologic saline in a 1-2 ml syringe). Small amounts should be injected at intervals, allowed time to take effect, and then patency checked.
  (The above-mentioned concentrations are recommendations and must always be adapted to patient's coagulation status as monitored by a physician. The product description of all pharmaceuticals used should always be consulted.)
• The complication rate of thrombus formation in the catheter can be reduced in patients at risk by low-dose heparinization or, in arterial portal systems, by the administration of a platelet aggregation inhibitor (e.g. acetylsalicylic acid).

CAUTION
Causes of abnormally high resistance to access needle may include

• Incorrect placement of the access needle in the portal chamber
• bending and kinking of the catheter
• Fibrin deposition or thrombotic occlusion of catheter or port.

Blood deposits in the system generally indicate faulty handling, leakage or a defective septum inside the port.
When blood aspiration is not successful, the port should be flushed and the patient's position changed.

INDICATIONS FOR EXPLANTATION
The port can be removed under local anesthesia at the end of treatment. Other indications include:

• Irreversible obstruction of the portal system
• Infection of the portal system
• Breakage of catheter or damage to catheter
• Membrane leakage
• Poor patient compliance
• Massive thrombosis of the major vessels (subclavian vein, v.cava)
• Uncontrollable infection (port removal only under general anesthesia)

WARNINGS

• The port should be secured to surrounding subcutaneous tissue by sutures or placed in the smallest of portal pockets in order to prevent port migration.
• The catheter must be secured to the vein with a firm, but not constricting suture.
• The proper connection of the catheter to the port should be confirmed.

PRECAUTIONS
Sterility

Meticulous hygiene and sterile handling technique are mandatory for the safe usage of TITAN-PORT Systems.This includes:

• Implantation in sterile OR setting
• Proper disinfection of hands and skin
• Sterile gloves when initiating treatment
• Use of sterile products

AFTERCARE AND MONITORING

Regular treatment sessions and associated care of the port system are coincidental with monitoring of the port system.
Port systems should not be used by physicians / health care personnel not familiar with all aspects of the product and its potential complications. Complications can occur at any time during and after implantation.