Integra CONTOUR-FLEX Instrucciones De Uso página 4

Sistemas de valvula y derivacion
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Assembling the Shunt
Note: If the Ventricular Catheter is not pre-attached to valve, follow steps 1 and 2 below.
1.
To connect Ventricular Catheter to the valve, insert valve's proximal connector into open end of catheter. Ensure
catheter covers the entire connector.
2.
Secure connection with an encircling ligature.
Note: If the Distal Catheter is not pre-attached to valve, follow steps 3 and 4 below.
3.
Insert valve's distal connector into open end of catheter. Ensure Distal Catheter covers the entire connector.
4.
Secure the connection with an encircling ligature.
Injection
The reservoir is designed to allow penetration with a 25-gauge, or smaller, beveled needle. The reservoir contains a
polypropylene needle guard to prevent overpenetration of the needle. The valve membrane is protected from needle
punctures by a polypropylene cartridge. However, care should be taken to avoid this area when inserting a needle.
Puncturing the valve membrane may affect the pressure/flow characteristics of the valve.
Note: Neither catheter tubing nor occluders should be used as injection sites.
CAUTION: Low tear strength is a natural property of most non-reinforced silicone materials. Use care during
insertion and removal of the needle. Insert needle at an angle approximately 45° from the scalp or base of the
valve. If valve reservoir is to be punctured several times, insert needle at different locations to avoid multiple
punctures at a single point.
Flushing the Valve
1.
To flush CSF from valve in both distal and proximal directions, use finger pressure to transcutaneaously depress the
reservoir.
2.
To flush in one direction only, depress the occluder opposite the reservoir from the catheter to be flushed, and pump
reservoir.
Note: A reservoir dome with noticeable resistance to compression could indicate an occluded catheter.
CAUTION: Avoid unnecessary testing and pumping of valve. Frequent pumping can lead to overdrainage of the
ventricles, particularly if ventricle size is small.
Pre-Implant Valve Patency Test
1.
Place inlet connector of valve into sterile fluid (e.g. irrigation water, physiological saline).
2.
Repetitively depress reservoir until fluid flows from outlet connector. Valve is patent if fluid flows from outlet
connector with each press of the reservoir.
3.
Finally, be sure to remove all large bubbles from the shunt system. It is not necessary to remove small bubbles.
Note: If Distal Catheter slits are stuck together, fill the shunt system with sterile fluid, then roll slits gently between
fingers to lubricate and open the slits.
Note: To perform an alternative patency test, attach a syringe to the valve's proximal inlet connector and gently flush
with sterile fluid.
Pre-Implant Valve Pressure Test
Every Integra NeuroSciences Contour-Flex Valve is individually tested to ensure it meets rigorous specifications and
pressure/flow characteristics. If however, the surgeon wishes to verify the closing pressure of the valve is as stated in the
specifications, the following procedure may be performed in the operating room.
CAUTION: Use extreme care to maintain sterility and avoid particulate contamination.
Equipment needed (sterile)
1.
Fluid reservoir or water bath
2.
30 cm or larger manometer, graduated in centimeters wih a 3-way stopcock
3.
30 cc – 60 cc syringe
4.
Tubing
5.
Blunt needle to connect syringe to tubing
6.
Sterile distilled water or physiological saline
4
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