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Power injector machine pressure limiting feature may not prevent
over pressurization of an occluded catheter.
•
Exceeding the maximum flow rate may result in port system failure
and/or catheter tip displacement.
•
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 325 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:
Grade
Severity
Grade 0
No distortion
Distortion
present
without
Grade 1
luminal
narrowing
Distortion
present with
Grade 2
luminal
narrowing
Catheter
Grade 3
transection or
fracture
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If the guidewire must be withdrawn while the needle is inserted,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.
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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3,4
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