Indications For Use - MedComp DIGNITY Gebrauchsanleitung

DESCRIPTION:
• The Dignity
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 Dignity
port with self sealing septa and a radiopaque catheter. The Dignity
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 Dignity
is indicated for patient therapies requiring repeated access to the vascular
system. The Dignity
fluids, parenteral nutrition solutions, blood products, and for the withdrawal
of blood samples.
• When used with a power injectable needle, the Dignity
for power injection of contrast media. For power injection of contrast media,
the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge
non-coring power injectable needle. The maximum recommended infusion rate
is 2 ml/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 RE-USE. Medcomp
•
single use devices and should never be reimplanted. Any device that has been
contaminated by blood should not be re-used 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.
• Do not proceed if resistance is felt or interaction between components is
failing.
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.
• Dignity Dual 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.
• Dignity Dual 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 Dignity
Dual power injectable implantable infusion port device.
Dual power injectable implantable infusion port is an implantable
®
Dual Port device consists of two primary components: an injection
®
Dual Port is a power injectable implantable infusion port that
®
Dual Port can be used for infusion of medications, I.V.
®
1,2
-1-
Dual Ports
®
Dual Port is indicated
®
products are
®
®