Indications For Use; Contraindications - MedComp Dignity Titanium Gebrauchsanleitung

DESCRIPTION:
• The Power Injectable Implantable Infusion Port is an implantable access
device designed to provide repeated access to the vascular system. Port
access is performed by percutaneous needle insertion using a non-coring
needle. Power injection is performed using a power injectable needle
only. The Power Injectable Implantable Infusion Port device consists of two
primary components: an injection port with a self-sealing silicone septum
and a radiopaque catheter. Implantable Infusion Ports can be identified
subcutaneously by feeling the top of the septum and the top rim of the port
housing. Power Injectable Implantable Infusion Ports can be identified by
the letters "CT" under radiographic imaging.
• All materials are biocompatible. This device is not made with natural
rubber latex, and safe with CECT and is MR Conditional.
INDICATIONS FOR USE:
• The CT Power Injectable Implantable Infusion Ports are indicated for patient
therapies requiring repeated access to the vascular system. The port system
can be used for infusion of medications, I.V. fluids, parenteral nutrition
solutions, blood products, and for the withdrawal of blood samples.
• When used with a power injectable needle, the Power Injectable Implantable
Infusion Port device is indicated for power injection of contrast media. For
power injection of contrast media, the maximum recommended infusion rate
is 5ml/s with a 19 or 20 gauge non-coring power injectable needle.
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

CONTRAINDICATIONS:

• This device is contraindicated for catheter insertion in the subclavian vein
medial to the border of the first rib, an area which is associated with higher
rates of pinch-off.
CONTRAINDICATIONS:
• This device is contraindicated for catheter insertion in the subclavian vein
medial to the border of the first rib, an area which is associated with higher
rates of pinch-off.
• The device is also contraindicated:
• When the presence of device related infection, bacteremia, or septicemia
is known or suspected.
• When the patient's body size is insufficient for the size of the implanted
device.
• When the patient is known or is suspected to be allergic to materials
contained in the device.
• If severe chronic obstructive lung disease exists.
• If the prospective insertion site has been previously irradiated.
• If the prospective placement site has previously suffered episodes of
venous thrombosis or vascular surgical procedures.
• If local tissue factors will prevent proper device stabilization and/or
access.
WARNINGS:
I. During Placement:
Intended for Single Patient Use. DO NOT REUSE. Medcomp® products are
•
single use devices and should never be reimplanted. Any device that has been
contaminated by blood should not be reused or resterilized.
• After use, this product may be a potential biohazard. Handle and discard in
accordance with accepted medical practice and applicable local, state and
federal laws and regulations.
• During placement through a sheath, hold thumb over exposed opening of
sheath to prevent air aspiration. The risk of air aspiration is reduced by
performing this part of the procedure with the patient performing the Valsalva
maneuver.
• Do not suture catheter to port. Any damage or constriction of catheter may
compromise power injection performance.
• Avoid vessel perforation.
• Do not power inject through a port system that exhibits signs of clavicle-first
rib compression or pinch-off as it may result in port system failure.
II. During Port Access:
• DO NOT USE A SYRINGE SMALLER THAN 10ml. Prolonged infusion pressure
greater than 25 psi may cause damage to a patient's vessels or viscus.
• Power Injectable Implantable Infusion Ports are only power injectable
when accessed with a power injectable needle.
• Failure to warm contrast media to body temperature prior to power injection
may result in port system failure.
• Failure to ensure patency of the catheter prior to power injection studies may
result in port system failure.
• 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.
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