COOK Vital-Port Instrucciones De Uso página 3

The Vital-Port® Vascular Access System
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed prac-
ticioner).
INTRODUCTION
The Vital-Port Vascular Access System is a completely implantable subcutaneous system for patients who require repeated
intermittent vascular access for simultaneous or separate infusion and/or withdrawal of fluids. Power Injection of contrast
media may be performed on specified models when accessed with an infusion set indicated for power injection. The Vital-
Port System consists of either one or two independent injection port chambers, each with a self-sealing septum accessed
by percutaneous needle puncture using a non-coring needle, and a catheter.
The titanium or polysulfone port body has suture points that permit anchoring. (Fig. 1) In titanium models, these suture
points are silicone-filled. A silicone or polyurethane catheter, with a catheter lock, is supplied either pre-attached or
detached. A non-coring stainless steel needle is included with all models, and some systems also include a vascular access
introducer set, tunneler and non-coring infusion set.
Intended Use
The Vital-Port Vascular Access System is indicated for patient therapy requiring repeated vascular access for simultaneous
or separate injection or infusion therapy and/or blood sampling.
The following Vital-Port devices are indicated for power injection of contrast media when used with a power injectable
infusion set. For further information on using these models for contrast power injection, please refer to the Contrast
Power Injection using Vital-Port System section in these Instructions for Use.
• IP-7110
• IP-S7010
• IP-S7110
• IP-S9010
• IP-S9010P
• IP-S9110
• IP-S9110P
CONTRAINDICATIONS
The Vital-Port System should not be implanted in the presence of known or suspected infections, bacteremia, septicemia,
or peritonitis, or in patients who have demonstrated prior intolerance to the materials of construction.
WARNINGS
• Introduction of the catheter into the subclavian vein (Fig. 2, reference A) using standard percutaneous techniques
may subject the catheter to periodic compression forces within the narrow costoclavicular space between the clavicle
(Fig. 2, reference B) and first rib (Fig. 2, reference C). Reported complications from repeated subclavian compression
include catheter pinch-off syndrome, catheter fracture, and catheter shear followed by embolization of the distal
portion. The likelihood of catheter occlusion and damage can be greatly reduced by choosing an access site lateral to
the clavicle (preferably at or lateral to the midclavicular line) (Fig. 2, reference D) and prior to the vein entering the
thorax at the costoclavicular space.
• RECOMMENDED: Central Venous Catheter introduced at or lateral to midclavicular line (Fig. 2 reference E).
• AVOIDED: Central Venous Catheter introduced medial to costoclavicular space (Fig. 2, reference F).
• Prevent air embolism by applying finger pressure over the opening of the introducer sheath.
• Failure to adequately anchor the port to the fascia increases the risk of catheter fracture and/or disconnection which
could result in catheter migration.
Peripheral Implanted Port
• To avoid catheter damage to a vascular access system implanted peripherally in the upper arm, position the catheter so
that it enters the venous system in the lower third of the upper arm and below the vein's passage through the deep or
brachial fascia. Following insertion, confirm that the catheter follows a smooth course into the vein and that no abrupt
directional changes are present.
ENGLISH
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