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PakuMed Port PD PC AS PT 5098 PakuMed Kanule GW 6003 AszitesPeritoneal  

PakuMed Port PD PC AS PT 5098 PakuMed Kanule GW 6003 AszitesPeritoneal  

Product description AS/PT

The TITAN-PORT AS/PT allows repeated access to the peritoneal cavity if necessary while minimizing the justifiably feared rate of infection with external peritoneal catheters. Indications may be:

  • ascites puncture
  • peritoneal therapy

The advantage is a low risk of infection, simplified access and considerably improved quality of life for the patient as provided by the closed system.

Technical data

TITANPORT AS/PT (Ascites- or Peritonealtherapy)

 Art. No. Port   Catheter PZN
  Material Base Height
Septum Ø Weight
Reservoir Material French Reservoir   
111259 AS/PT*
Ascites- and peritoneal therapy port
Titanium 28,8 mm 15,5 mm 14 mm 18 g 1,4 ml Silicone 14,5 3,5 ml 10216623

*including introducer set and tunnelizer

instruction for use AS/PT

Titan-Port AS/PT (Ascites and Peritonealtherapy) is a totally implantable, titanium PORT system providing an access facility to the peritoneal cavity. The set contains a port chamber with a self-sealing silicone membrane and a single-lumen silicone catheter with a screw for connection to the port chamber and for fixing the catheter to the outlet tube. Each system also includes a special puncture needle, introducer set, tunnelizer, user instructions and patient ID- Card.

The port chamber is made of hypoallergenic biocompatible titanium. This material is non-magnetic. The chamber dimensions are: bottom diameter 29 mm, height 15,5 mm, weight 18 g and a silicone membrane with 14 mm diameter. The base plate has suture openings for securing the system to the fascia. Port chamber and catheter can be disconnected and are connected via a screw with the outlet tube.

The silicone membrane in the port (14 mm diameter, height 8 mm) can be punctured frequently with a suitable non- coring puncture needle. The membrane is highly resistant to pressure and holds the inserted needle reliably in place.

The silicone catheter 14.5 F has lateral holes and is precurved about approx. 12 cm at the distal end. It has a round tip and if necessary the catheter can also be shortened at the proximal (unperforated) end.

Only special non-coring portal access needles should be used to puncture the port membrane.

Depending on indication and flow rate different special puncture needles can be used. These may be the DPK 2035, DPK 1835 and SFN 1535 G as well as the smaller SFN® port needles in various sizes. The needles exhibit a unique bevel and angle at the tip. This prevents punch defects at the membrane when the needle is inserted. Each system contains a suitable needle. Appropriate accessories can be ordered separately if required.

The patient ID card is filled out by the physician who performes the implantation, and is handed to the patients who should always carry this document with them.

These instructions for use should also be available to nurses and doctors for ffollow-up care.

The contents of the product are labelled on each sterile double package.


INDICATIONS

The TITAN-PORT AS/PT allows repeated access to the peritoneal cavity if necessary while minimizing the justifiably feared rate of infection with external peritoneal catheters. Indications may be:

  • ascites puncture
  • peritoneal therapy

The advantage is a low risk of infection, simplified access and considerably improved quality of life for the patient as provided by the closed system.


CONTRAINDICATIONS

TITAN-PORT AS/PT systems are contraindicated in:

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

COMPLICATIONS AND POSSIBLE SIDE EFFECTS

 The following are examples of general complictions 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 according to the preferred puncture procedure. 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 water-tight purse-string 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 screw 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.


CARE OF THE SYSTEM / SPECIAL APPLICATION NOTES

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.


USER INSTRUCTION

  1. Skin desinfection, sterile gloves, mask
  2. Puncture the port septum with a special puncture needle with a mandrin (supplied) (until the tip of the needle touches the base plate)
  3. Remove the mandrin, check for occlusion with physiological saline solution and especially pay attention to possible extravasation.
  4. Attheendoftreatment,gentlywithdrawthepuncture needle (exerting opposite pressure at the port).
  5. Disinfecttheskin;applydrydressing

Caution:

  • Puncture the port chambers only with the special puncture needles (DPK 2035: flow rate approx. 2000 ml in 12 min)
  • Always insert the needle into the silicone membrane carefully and perpendicular to the baseplate with the mandrin accurately positioned.

For lower flow-rates other recommended SFN® port needles may be sufficient.

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 therapy no longer necessary
  • rreversible 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. When there are no complications, a puncture frequency of up to approx. 500 punctures (with DPK 2035) using a special needle allows a corresponding implantation time. 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°- 30°C and should be protected from direct sunlight.

Do not use products from damaged packaging.

Special puncture needles are available.

e. g.

  • DPK 2035 PZN 02429581
  • DPK 1835 PZN 05108104
  • SFN 1535 G PZN 10216563

SFN® port needles with different sizes and length. e. g.

  • SFN 1320 S PZN 07746257

Unit 25 pcs / package

Please pay attention to the separate instructions for use!

Port Needles

Product description port needles

Puncture of portchamber only with special port needles is mandatory!

  1. Needle with mandrin and needle free adapter for puncture of implanted dialysis portsystems or peritoneal portsystems- if a sufficient inner diameter is required for necessary flow. Non coring due to a special tip and mandrin
  2. Special non coring puncture needle with side hole

Art. No. Cannulas PZN
  Ø Lenght Gauge Volume Flow Puncture frequency Unit Extras  
SFN 1320 S 1,3 mm 20 mm 18  0,31 ml 72 ml/min ~ 3000 25 pcs curved, with tubing and clamp/Luer Lock 07746257 
SFN 1325 S 1,3 mm 25 mm 18 0,31 ml  72 ml/min ~ 3000 25 pcs curved, with tubing and clamp/Luer Lock 11094033 
SFN 1535 B 1,5 mm 35 mm 17 0,5 ml  in gravity 150 ml/min ~ 1500 25 pcs straight, with Luer Lock-Adapter, with tubing 12363624
SFN 1835 B 1,8 mm 35 mm 15  0,5 ml in gravity 225 ml/min ~ 1000 25 pcs straight, with Luer Lock-Adapter, with tubing 12363630
DPK 2035 2,0 mm 35 mm 14 0,3 ml in gravity 300 ml/min ~ 500 25 pcs with mandarin + needle free adapter 02429581


SFN-1535-G Ret
 SafeKanueleVorgang2 Ret verlauf gr rl

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