COOK Vital-Port Instrucciones De Uso página 4

• Abrupt directional changes may result in catheter fracture and subsequent possible embolization. A radiographic
confirmation of the catheter insertion should be made to ensure that the catheter is not being pinched.
For Warnings related to models indicated for contrast power injection, please refer to the Contrast Power Injection using
Vital-Port System section in these Instructions for Use.
Power Injection
• The indication for power injection of contrast media implies the port system's ability to withstand the procedure, but
does not imply appropriateness of the procedure for a particular patient. A trained clinician is responsible to evaluate
the health status of the patient, the integrity of the port system and the ability of staff to properly access the system for
power injection.
• Verify that the port system is power injection compatible prior to using it for such a procedure. Check the patient's
medical records and/or patient identification materials.
• If the catheter and lock are connected and then disconnected the catheter must be re-trimmed to ensure a secure
re-connection.
• The Vital-Port Vascular Access Systems are only indicated for power injection when using the supplied port in
conjunction with the catheter included in the tray.
• Do not place sutures on catheter, as catheter may be compromised.
• The Vital-Port Vascular Access Systems are only indicated for power injection when accessed with a power injectable
infusion set.
• Failure to use an infusion set indicated for power injection may result in needle component failure.
• Do not exceed the maximum flow rate; doing so may result in septum leakage, catheter displacement and/or system
failure.
• Do not exceed the maxium pressure; doing so may result in septum leakage, catheter displacement and/or system
failure.
• Failure to ensure patency of the catheter lumen prior to injection may result in catheter failure.
• Do not use a port system that exhibits signs of compression or obstruction, as it may result in port system failure.
• Do not force injection or withdrawal of fluids through an impeded lumen. Notify attending physician immediately.
• Stop the injection immediately if local pain, swelling or sign of extravasation are noted.
• Flow rates were achieved using room temperature contrast at 11.8 centipoise. A change in temperature or viscosity of
the contrast media used will result in a change in achievable flow rates.
• It is recommended that a 10 ml or larger syringe be used for injecting or infusing fluids through the system by hand.
PRECAUTIONS
General
• Consult the "Suggested Instructions for Use" before implanting or accessing the product.
• Use asceptic technique when implanting or accessing the device.
• Use talc-free gloves for handling the device.
• To avoid the potential problems associated with unnecessary or improperly maintained long-term device placement,
consider removing the entire port system following cessation of therapy. A post-operative x-ray is suggested to verify
system removal.
Implant Considerations
• Withdrawal or manipulation of distal spring coil portion of wire guide through needle tip may result in breakage.
• Avoid positioning the port septum directly below the incision line since the septum will be punctured repeatedly.
• Avoid contacting the catheter with sharp objects which may lead to catheter shearing.
• Avoid excessive clamp force which could damage the catheter. Clamp the catheter only on a section that will be cut off
prior to implant. If the catheter was previously cut to length, keep the distal end elevated rather than clamping.
• Avoid trimming the catheter at an angle: an angled catheter tip can be sealed off against the side of a vessel.
• Improper catheter connection may result in catheter damage, leakage, or possible disconnection.
• Prior practice is recommended to ensure dexterity in connecting the catheter to the port. However, do not practice
making a port-catheter connection with a catheter intended for implantation; doing so may result in catheter damage.
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