MedComp Dignity Titanium Gebrauchsanleitung Seite 4

• Power Injectable Implantable Infusion Port device indication for power injection
of contrast media implies the Port's ability to withstand the procedure, but does
not imply appropriateness of the procedure for a particular patient nor for a
particular infusion set. A suitably trained clinician is responsible for evaluating
the health status of a patient as it pertains to a power injection procedure and
for evaluating the suitability of any infusion set used to access the port.
• Do not exceed a 300 psi pressure limit setting, or the maximum flow rate
setting on the power injection machine, if power injecting through the Power
Injectable Implantable Infusion Port device.
• Medical procedures on a patient's arm in which the system is implanted
should be restricted as follows:
• Do not withdraw blood from or infuse medication into any area of the arm
where the system is located unless you are using the port
• Do not measure the patient's blood pressure on this arm
SIGNS OF PINCH-OFF:
Clinical:
• Difficulty with blood withdrawal
• Resistance to infusion of fluids
• Patient position changes required for infusion of fluids or blood withdrawal
Radiologic:
• Grade 1 or 2 distortion on chest x-ray. Pinch-off should be evaluated for degree
of severity prior to explantation. Patients indicating any degree of catheter
distortion at the clavicle/first rib area should be followed diligently. There are
grades of pinch-off that should be recognized with appropriate chest x-ray as
follows:
3,4
Grade
Grade 0
Grade 1
Grade 2
Grade 3
PRECAUTIONS:
• Carefully read and follow all instructions prior to use.
• Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
• Only qualified healthcare practitioners should insert, manipulate and remove
these devices.
• Avoid inadvertent puncture of the skin or fascia with the tip of the tunneler.
• If the guidewire must be withdrawn while the needle is inserted, remove both
the needle and wire as a unit to help prevent the needle from damaging or
shearing the guidewire.
• Use only non-coring needles with the port.
• Prior to advancing the catheter lock, ensure that the catheter is properly
positioned. A catheter not advanced to the proper region may not seat securely
and lead to dislodgment and extravasation. The catheter must be straight with
no sign of kinking. A slight pull on the catheter is sufficient to straighten it.
Advancing the catheter lock over a kinked catheter may damage the catheter.
• Follow Universal Precautions when inserting and maintaining the catheter.
• Follow all contraindications, warnings, precautions and instructions for all
infusates as specified by their manufacturers.
• Precautions are intended to help avoid catheter damage and/or patient injury.
• When utilizing the port for arm placement, the port should not be placed in
the axillary cavity.
I. Prior to Placement:
• Examine package carefully before opening to confirm its integrity and that the
expiration date has not passed. The device is supplied in a sterile package and
is non-pyrogenic. Do not use if package is damaged, opened or the expiration
date has passed. STERILIZED BY ETHYLENE OXIDE.
• Do not resterilize or reuse. Re-use may lead to infection or illness/injury.
Severity
No distortion
Distortion
present
without luminal
narrowing
Distortion
present with
luminal
narrowing
Catheter
transection or
fracture
STERILE EO
Recommended Action
No action
Chest x-ray should be taken every one to
three months to monitor progression of
pinch-off to grade 2 distortion. Shoulder
positioning during chest x-rays should be
noted as it can contribute to changes in
distortion grades.
Removal of the catheter should be
considered.
Prompt removal of the catheter.
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