MedComp DIGNITY Gebrauchsanleitung Seite 5

II. During Placement:
• Do not allow accidental device contact with sharp instruments. Mechanical
damage may occur. Use only smooth edged, atraumatic clamps or forceps.
• Take care not to perforate, tear, or fracture the catheter during placement.
After assembling catheter to port, check assembly for leaks or damage.
• Do not use the catheter if there is any evidence of mechanical damage or
leaking.
• Do not bend catheter at sharp angles during implantation. This can
compromise catheter patency.
• Carefully follow the connection technique given in these instructions to ensure
proper catheter connection and to avoid catheter damage.
• Do not use sutures to secure catheter to the port stem as it could collapse or
damage the catheter.
• When using peel-apart introducers:
– Carefully insert the introducer and catheter to avoid inadvertent penetration
to vital structures in the thorax.
– Avoid blood vessel damage by maintaining a catheter or dilator as internal
support when using a peel-apart introducer.
– Avoid sheath damage by simultaneously advancing the sheath and dilator as
a single unit using a rotational motion.
POSSIBLE COMPLICATIONS:
• The use of a subcutaneous port provides an important means of venous
access for critically ill patients. However, the potential exists for serious
complications, including the following:
• Air Embolism
• Bleeding
• Brachial Plexus Injury Cardiac Arrhythmia Cardiac Tamponade
• Catheter or Port Erosion Through the Skin
• Catheter Embolism
• Catheter Occlusion
• Catheter Occlusion, Damage or Breakage Due to Compression Between
the Clavicle and First Rib
• Catheter or Port Related Sepsis
• Device Rotation or Extrusion
• Endocarditis
• Extravasation
• Fibrin Sheath Formation
• Hematoma
• Hemothorax
• Hydrothorax
• Intolerance Reaction to Implanted Device
• Inflammation, Necrosis, or Scarring of Skin Over Implant Area
• Laceration of Vessels or Viscus
• Perforation of Vessels or Viscus
• Pneumothorax
• Spontaneous Catheter Tip Malposition or Retraction
• Thoracic Duct Injury
• Thromboembolism
• Vascular Thrombosis
• Vessel Erosion
• Risks Normally Associated with Local or General Anesthesia, Surgery,
and Post-Operative Recovery
• These and other complications are well documented in medical literature and
should be carefully considered before placing the port.
IMPLANTATION INSTRUCTIONS:
• Please read through complete implantation instructions before implanting
port, noting "Contraindications, Warnings, and Precautions" and "Possible
Complications" sections of this manual before beginning procedure.
PREVENTING PINCH-OFF
• The risk of pinch-off syndrome can be avoided by inserting the catheter via the
internal jugular vein (IJ). Subclavian insertion of the catheter medial to the
border of the first rib may cause catheter pinch-off, which in turn results in
occlusion causing port system failure during power injection.
• If you choose to insert the catheter into the subclavian vein, it should be
inserted lateral to the border of the first rib or at the junction with the axillary
vein because such insertion will avoid compression of the catheter, which can
cause damage and even severance of the catheter. The use of image guidance
upon insertion is strongly recommended. A radiographic confirmation of
catheter insertion should be made to ensure that the catheter is not being
pinched.
IMPLANTATION PREPARATION
Select implantation procedure to be used. Note: Recommended veins for arm
1.
placement are cephalic, basilic, or medial cubital basilic. Note: Recommended
veins for chest placement are internal jugular or lateral subclavian. Refer
to "Warning" section covering catheter pinch-off if inserting the catheter via
subclavian vein.
Select the site for port placement. Note: Port pocket site selection should
2.
allow for port placement in an anatomic area that provides good port stability,
does not interfere with patient mobility, does not create pressure points, has
not previously been irradiated, does not show signs of infection, and does not
interfere with clothing. For arm port placement, site should be distal to the
desired vein insertion site. Consider the amount of cutaneous tissue over the
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