SFN® - Port Needles \ Usage information

Seperator

Instruction for use
Non-coring puncture needles for implanted port/catheter systems needle with tubing and clamp for implanted port/catheter systems

COMPONENTS

  • Special needle made of surgical steel with a special punch-free bevel (Trocar)
  • Grip and fixation wings are foldable and made of polyurethane (PUR)
  • Connective tubing made of polyurethane (PUR)
  • Luer-Lock connector made of polycarbonate (PC)
  • Clamp and- removable grip made of polymethylene (POM)

INDICATIONS

  • continuous or intermittent administration of pharmaceuticals, infusions, blood transfusions, blood samples, parenteral nutrition etc.
  • pain therapy
  • central venous access perioperatively, CVP-monitoring

CONTRAINDICATIONS

  • inflammation or infection at portal site
  • coagulation disorders
  • portal system leakage

WARNINGS AND PRECAUTIONS
Skin and soft tissue infections or infections of the entire portal system are possible if sterile techniques are not used.

Warning: Puncture of the port should be performed in the supine position to prevent air embolism. Negative pressure gradients develop in the superior vena cava in the sitting position or when the torso is elevated. During puncture of the port, air can be sucked into the system via the needle. Therefore the closure mechanism of the infusion tubing should be checked during puncture or when changing syringes.
When not in use, the tubing should be occluded with a screw stopper.

RECIPROCAL EFFECTS
None

GENERAL RECOMMENDATIONS
It is recommended that the needle be left in place no longer than 48 hours.

PROCEDURES

Puncture:

  • Have patient in a supine position
  • Carefully disinfect the skin
  • The use of sterile gloves is recommended but not mandatory
  • Remove the needle from the peel packaging
  • Connect the Luer connector to syringe or infusion
  • Remove air from the tubing by flushing with 0.9% NaCl
  • Fold wings of the fixation plate upwards to be used as a grip for advancement of the needle
  • Remove the needle protection sleeve
  • Gently hold the port and fixation between two fingers
  • Advance the needle quickly through the port membrane perpendicular to the base of the port (no danger of bending of the needle due to special bevel of the tip)
  • Fix the needle with the tape

Warning: Needles are available in various lengths to ensure that a space remains between the skin and the fixation plate. This is to prevent dislocation of the needle by movement of underlying tissues such as the muscles.

Interruption of infusion, removal of infusion system while needle still in place

  • If not in use for longer periods the system should be filled with physiologic saline
  • Clamp tubing with closure mechanism
  • Connect appropriately sized Luer Lock to the connection site

Removal of the needle

  • After and between injection of pharmaceuticals the portal system should be flushed with physiologic 0.9% saline (possible pharmaceutical incompatibility).
  • The system must be filled with saline after each use.
  • The needle may be removed toward the end of saline injection under slight positive syringe pressure.
  • The port chamber should be held in place below the skin level during needle withdrawal.
  • The injection site is then covered by a sterile band-aid.

Important: The needle should be removed only when clamp is closed to prevent blood flow into the system. Do not use syringes less than 10ml volume to prevent excessive pressures.

Warning: Blood deposits in the system generally indicate faulty handling, leakage, or a defective septum inside the port

If a thrombus in the port is suspected, the use of fibrinolytic agents such as streptokinase or urokinase is possible. These recommendations require observation of the manufacturer's guidelines regarding dosages and contraindications. In pain therapy via peridural or intrathecal catheters the use of a bacterial filter is recommended. It is prohibited to flush these systems.

Maximal flow rates (aqueous solutions) of various SFN®-Needles of various diameters and lengths to determine infusion rate:
18 gauge, ED 1.3 mm, ID 1.0 mm, puncture length 20 mm = 1000 ml in 11 minutes
19 gauge, ED 1.1 mm, ID 0.8 mm, puncture length 20 mm = 1000 ml in 20 minutes
20 gauge, ED 0.9 mm, ID 0.6 mm, puncture length 20 mm = 1000 ml in 39 minutes
22 gauge, ED 0.7 mm, ID 0.4 mm, puncture length 20 mm = 1000 ml in 80 minutes

Single use medical product. Non-resterilizable. The needle is sterile and non-pyrogenic as long as pakkaging is undamaged. The packed products should be stored at temperatures ranging from 5-35 °C. Avoid direct sunlight. Do not use if expiration date on packaging is exceeded.

  
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