INDICATION

The TITAN-PORT PD allows repeated access for peritoneal dialysis as required, particularly also for self-treatment by the patient. An advantage also lies in the minimizing of the justifiably feared rate of infection in peritoneal dialysis.

CONTRAINDICATIONS

TITAN-PORT PD systems are contraindicated in:

• patients with very rare but possible intolerance to titanium, polyurethane or silicone
• suspected bacteremia / sepsis
• disseminated intravascular coagulation (DIC)

COMPLICATIONS and possible side effects

The following are examples of general complications and possible side effects:

• surgical complications
• implant intolerance
• localized erythema / edema / hematoma
• infections
• disconnection and dislocation
• membrane and catheter luxation
• paravascular deposits due to improper handling
• damage to surrounding tissue
• leakage from chamber, septum or connection sites
• injuries to abdominal organs

APPLICATION NOTES: PORT IMPLANTATION

Warning: It is essential to ensure aseptic conditions during implantation!
Selection, decision-making and technique are the responsibility of the physician performing implantation.
Implantation is normally performed under insufflation anesthesia.
Possible implantation sites are the right or left abdominal wall according to the preferred puncture procedure (particularly with self-puncture).
Implantation is performed similar to that used with the Tenckhoff catheter. Various implantation techniques can be employed.

After successful placing of the catheter in the abdominal cavity, it is particularly important to provide a watertight pursestring suture at the entry point of the catheter into the peritoneum!

Tunneling to the port in a port recess in the abdominal wall.
Shorten the catheter as required and secure it close to the skin with the cuff by squeezing at the port
Cutaneous sutures
With optimum implantation, the system can be used after approx. 3 days if the peritoneum is tightly closed at the catheter entrance.

USER INSTRUCTIONS

- On each occasion before treatment, ensure the correct position of the port chamber by palpation, and check that there is no wound or infection present.

GEBRAUCHSANWEISUNG

• Skin disinfection, sterile gloves
• Puncture the port septum with a special puncture needle with a mandrin (supplied) (until the tip of the needle touches the base plate)
• Remove the mandrin, check for occlusion with dialyzing fluid and connect to the dialyzer bag.
• At the end of dialysis, gently withdraw the puncture needle (exerting opposite pressure at the port).
• Disinfect the skin; apply dry dressing

Caution:

Puncture the port chambers only with the special puncture needles with a

• mandrin (flow rate approx. 2000 ml in 12 min)
• Always insert the needle into the silicone membrane carefully and per-pendicular to the base plate with the mandrin accurately positioned

Causes for abnormally high puncture resistance can include:

• Incorrect placement of the tip of the needle in the portal cavity
• Fibrin deposits blocking catheter or port.

(The stated concentrations are recommendations and must always be adapted to individual patient requirements and are the responsibility of the therapist. Medication and solutions employed are basically subject to the directions provided by the pharmaceutical manufacturers. Attention must be given to the specific requirements of the peritoneal dialysis. The port systems provide only an access route for peritoneal dialysis and have no influence on the function itself).

INDICATIONS FOR EXPLANTATION

• When dialysis no longer necessary
• Irreversible occlusion of the system
• Membrane or catheter leaks
• Infection

WARNING NOTES

• Secure the ports in the subcutaneous tissue with single sutures or place them in the smallest possible subcutaneous recess to prevent migration.
• Ensure that the catheter is firmly connected to the port chamber

After a lengthy implantation period or system use, check the membrane for leakage resulting from frequent punctures.
Where there are no complications, a puncture frequency of up to approx. 500 punctures using a special needle allows a corresponding implantation time depending on the frequency of dialysis.
It is possible to exchange the port chamber in the event of silicone membrane leakage also under local anesthesia.

PRECAUTIONS

Meticulous hygiene and sterile handling technique are mandatory for this system, e.g.

• Implantation under sterile surgical conditions
• Disinfect hands and skin
• Only sterile products to be used

MONITORING

Regular usage followed by system care and maintenance provide continuous monitoring.

The system should not be used by physicians / medical staff who are not familiar with the product and/or possible complications. These can occur at any time during or after the intervention.

Prior to use, the packaged product should be stored in dry conditions as far as possible at temperatures of 5° - 35° C and should be protected from direct sunlight.
Do not use products from damaged packaging.