less painful due to lower skin resistance at puncture
higher safety for the patient
Instruction for use Non-coring puncture needles for implanted port/catheter systems needle with tubing and clamp for implanted port/catheter systems
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)
continuous or intermittent administration of pharmaceuticals, infusions, blood transfusions, blood samples, parenteral nutrition etc.
central venous access perioperatively, CVP-monitoring
inflammation or infection at portal site
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.
It is recommended that the needle be left in place no longer than 48 hours.
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.
Removal of SFN-Safety-Portneedle with simple downward turn of safety clip until it clicks
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 bac terial 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.