Indications For Use - MedComp DIGNITY Instructions D'utilisation

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 is 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. The maximum
recommended infusion rate is 2ml/s with a 22 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.
• 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.
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