Integra NeuroSciences OSV II Instrucciones De Uso página 6

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To minimize the possibility of underdrainage in patients confined to a supine position (i.e., patients under 3 months
of age and bedridden patients), these patients should be elevated at a 45° angle for several hours a day (using a
pillow, etc.) until they can sit or stand independently.
Caution - Do not overpressurize the valve system. Excessive flushing pressures may lead to valve damage.
Caution - Do not use in conjunction with other devices, such as antisiphon devices or distal slit valves. Addition of such
components would change the flow/pressure characteristics of the valve.
Storage and Transport: The valve systems in Integra NeuroSciences packaging may be stored at room temperature. They
will withstand the conditions of normal transport. This product is recommended for single use only. Do not implant
explanted systems or components in another patient. This product is sterilized with ethylene oxide. Do not use if the
package is open or damaged. Use the device prior to the "Use Before" date on the package label.
Caution - Do not resterilize. Integra NeuroSciences will not be liable for any direct, indirect, incidental or
consequential damages resulting from or related to resterilization.
OSV II PRESSURE / FLOW TEST
Each OSV II is tested at the end of the manufacturing process. Integra NeuroSciences does not recommend to test the
valve in the operating room, before implantation, for obvious reasons of possible contamination, and because the
conditions required for this testing are difficult to meet in a clinical environment.
PREIMPLANT TESTING FOR PATENCY
Should verification of valve patency be desired prior to implantation, place the inlet of the valve system in a container of
sterile apyrogenic saline solution. Connect a syringe, with the Luer connector attached to the drainage catheter, and
gently draw the solution through the system to displace air (Figure 3). Remove syringe and Luer connector. Holding the
valve's inlet end in the sterile solution, allow the drainage catheter to hang freely (Figure 3). The valve is patent if
solution drips from the drainage catheter.
Note - This procedure only tests the valve patency. It does not allow verification of the 3 different stages of operation of
the OSV II.
RECOMMENDED IMPLANTATION PROCEDURE
Before implantation, the valve serial number should be recorded in the patient's file.
Clinical Judgment
Incision size, size and type of nonabsorbable suture material, etc. should be selected according to the surgeon's
experience and preference. Procedure may be varied in accordance with the surgeon's clinical judgment.
Ventriculoperitoneal Approach
The described procedure is based on the use of a separate ventricular catheter and a specific type of peritoneal introducer.
If a valve with an integral ventricular catheter is used, follow the procedure "Introduction of Integral Ventricular
Catheter".
Place the patient in the supine position. Administer anesthesia. To facilitate tunneling, the head is turned to the
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contralateral side, placing the abdomen, thorax, neck and skull of the occipital region on a straight plane. Padding
may be placed under the neck to facilitate alignment.
Note - The skull incision location depends on the ventricular approach (frontal, temporal or occipital).
Expose the skull by making a 25 mm linear incision. Using a perforator, make a burr hole 3.0 mm or larger.
2.
Using an electrocoagulator, make an opening in the dura just large enough for ventricular catheter passage. For
systems with burr hole cap: using a perforator, make a burr hole larger than 6.5 mm. The technique may be varied
according to the surgeon's experience.
Using blunt dissection, create a small pocket under the skin to avoid unnecessary pull strength on the drainage
3.
catheter when positioning the shunt. Pass the Integra NeuroSciences disposable, malleable tunneler from the
subcutaneous pocket to the abdominal area, directing the tunneler tip by trapping it between the thumb and the index
finger. The tunneler may be deformed to follow body contours.
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