Integra CONTOUR-FLEX Instrucciones De Uso página 3

INDICATIONS
The Integra NeuroSciences Contour-Flex Valve is used in treatment of patients with hydrocephalus. It is a component of
a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the
atrium of the heart or to the peritoneal cavity.
INSTRUCTIONS FOR USE
Surgical Procedure
The implantation of a shunt system including placement of the Ventricular Catheter, Distal Catheter, and valve may be
accomplished through a variety of surgical techniques. The surgeon is best advised to use the method which his/her own
practice and discretion dictate to be best for the patient.
It is recommended the valve be placed in a surgically created subgaleal pocket and not under a scalp incision. The valve
should not be placed under the skin of the neck, chest or abdomen.
Ventricular Catheter Placement
It is recommended that catheter insertion is the last step of the shunt placement to minimize CSF loss during the
procedure.
A stainless steel sytlet is provided with the catheter, inserted in the central lumen, to assist its introduction into the
ventricle. Once the catheter is placed the stylet can be removed from the catheter.
If a valve with an integral catheter is used, a ventricular catheter introducer is provided with the catheter, to assist its
introduction into the ventricle. Lock the stylet of the ventricular catheter introducer into its cannula. Insert the tip of the
introducer into the second hole from the tip of the ventricular catheter. Align the catheter with the introducer cannula and
snap it into the adjustable plastic collar.
Caution: To avoid improper placement, do not overstretch the ventricular catheter when positioning it on the introducer.
Puncture the ventricle with this assembly. Carefully withdraw the stylet from the introducer cannula, causing the
ventricular catheter to disengage from the stylet. Disengage the catheter from the collar on the cannula, ensuring that the
catheter's position is maintained. Remove the introducer cannula from the burr hole.
If the right angle guide is used, follow these steps:
1. The right angle guide may be used as a marker to plan the depth of catheter insertion. Prior to insertion, slide the
right angle guide the approximate desired distance from the proximal tip of catheter.
2. Use the right angle guide to bend the Ventricular Catheter at a right angle where it exits the twist drill or burr hole.
3. After placement of the Ventricular Catheter, press the extracranial portion of the catheter into the split tubular
segment of the right angle guide to form a right angle bend. Wetting the catheter with sterile isotonic fluid may
facilitate sliding the right angle guide over the catheter.
4. Secure the right angle guide to surrounding tissue with sutures.
Note: If the right angle guide is not used, it may be removed at the time of surgery. It is recommended that the surgeon
trim the rim of the twist drill or burr hole to provide a beveled notch for proper catheter curvature.
Distal Catheter Patency Check
Prior to use, check distal end of catheter to ensure slits are open. This is accomplished through the following:
1. Using thumb and forefinger, hold the section of catheter containing slits. Gently roll catheter slits between thumb
and forefinger.
2. Next, hold catheter on both sides of slits, then push slits together.
3. Once again, gently roll slits between thumb and forefinger to ensure all slits are properly seated.
To flush Distal Catheter before use, insert a full syringe of sterile fluid (e.g. irrigation water, physiological saline) into
proximal end of catheter, and gently flush. A blunt 17-gauge needle may be used if necessary.
Distal Catheter Placement
During implantation, the proximal end of catheter may be trimmed to the appropriate length required for its particular use
(Note: This applies to shunts with a separate Distal Catheter only). The distal end may be trimmed if wall slits are not
required).
Integra NeuroSciences subcutaneous catheter passers are available for tunneling of the catheter.
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