Integra OSV II Lumbar Valve Systems Mode D'emploi page 5

• Possible complications of lumboperitoneal shunting include arachnoiditis, scoliosis, hyperlordosis, and back pain.
• Perforation of an abdominal viscus is a rare complication.
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.
• Other than trimming catheters, modifications are not recommended.
• The kits contain the non-implanted accessories used to aide in implantation. Do not bring these accessories into the MR
environment as serious injury can occur.
• Note - 10 cm of the Lumbar catheter will add, at 10 ml/hr, an extra resistance of 3.1 mmH₂0 (hydrodynamic resistance of the
Lumbar catheter: 0.031 mm H₂0 per ml/hr and per cm).
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. Addition of such components 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 LUMBAR VALVE PRESSURE / FLOW TEST
Each OSV II Lumbar 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 a approximately 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 OSV
II Lumbar 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.
Modifications
The lumbar and drainage catheters can be trimmed to the desired length during the implantation procedure. The lumbar cath-
eter should be trimmed only at its distal end since the proximal end contains drainage holes necessary for proper function. Other
modifications are not recommended.
Preparation
1. Administer appropriate anesthesia.
2. Place the patient in the lateral position, left side up. Instruct the patient to flex the right (lower) leg and to extend the left
(upper) leg.
3. Prepare and drape the lower back, hip and abdomen.
4. Make an incision above the iliac crest.
This product is sterilized with ethylene oxide. Do not use if the package is open or damaged. Use
.
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