Integra OSV II Mode D'emploi page 6

PRECAUTIONS
• Closely observe patients with an implanted valve system for shunt failure symptoms (see "Side Effects").
• During implantation, have duplicates of each component available.
• Handle valve tubing carefully. Cover forceps and clamp jaws with silicone elastomer tubing.
• Do not lubricate valves. They will be lubricated adequately by CSF.
• Silicone elastomer requires special handling to prevent contamination. Avoid contact with glove talc or skin oils.
• The drainage catheter may be trimmed to the desired length during implantation. Other modifications are not recommended.
• 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.
• Some kits contain the non-implanted accessories used to aide in implantation. Do not bring these accessories into the MR
environment as serious injury may occur.
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 compo-
nents change the flow/pressure characteristics of the valve.
Caution: This product is for single use only. Re-sterilization and re-use may affect its performances and characteristics and may
present a contamination risk (such as Creutzfeldt-Jakob disease).
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or practitioner.
Storage and Transport: The valve systems in Integra packaging may be stored at room temperature. They will withstand the
conditions of normal transport.
the device prior to the «Use by» date on the package label.
Caution - Do not resterilize. Integra will not be liable for any or all damages including, but not limited to, direct, indirect, inci-
dental, consequential or punitive damages resulting from or related to resterilization.
OSV II PRESSURE / FLOW TEST
Each OSV II Valve System is tested at the end of the manufacturing process. Integra does not recommend testing the valve in the
operating room before implantation due to risk 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. Time between each drop will be approximatively 4-6 seconds.
Note: This procedure only tests the valve patency. It does not allow verification of the 3 different stages of operation of the
Integra OSV II Valve System.
RECOMMENDED IMPLANTATION PROCEDURE
Before implantation, the valve serial number should be recorded in the patient's file.
Note: After implantation, complete the patient identification card for the patient or family.
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».
1. Place the patient in the supine position. Administer anesthesia. To facilitate tunneling, the head is turned to the contralat-
eral 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).
2. Expose the skull by making a 25 mm linear incision. Using a perforator, make a burr hole 3.0 mm or larger. Using an electro-
coagulator, 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.
3. Using blunt dissection, create a small pocket under the skin to avoid unnecessary pull strength on the drainage catheter
when positioning the shunt. Pass the Integra disposable, malleable tunneler from the subcutaneous pocket to the abdom-
inal area, directing the tunneler tip by trapping it between the thumb and the index finger. The tunneler may be deformed
to follow body contours.
Note: An alternate method may be necessary when the tunneler is not long enough or when the patient's position pre-
cludes a single pass without an interim incision.
Make the abdominal incision. Remove the handle of the tunneler. Attach the drainage catheter to the connector of the
internal tunneler wire, and pass the catheter from the head to the abdominal incisions. Remove the metal outer shaft. Pull
on the distal end of the drainage catheter. Position the valve under the skin.
4. Place the introducing rod into the ventricular catheter. If the Right Angle Guide (RAG) is used, introduce the ventricular
catheter into the center of the RAG and insert the catheter into the ventricle. Holding the catheter with covered forceps,
remove the introducing rod. Verify adequate CSF flow.
For systems with burr hole cap: trim the ventricular catheter to the desired length. Insert the ventricular catheter into the
burr hole reservoir and tie with non absorbable suture. Using the introducing rod, insert the catheter into the ventricle.
Verify adequate flow.
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This product is sterilized with ethylene oxide. Do not use if the package is open or damaged. Use
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