Integra Codman CERTAS Plus Mode D'emploi page 20

EN – ENGLISH
Integra will not be responsible for product that is re-sterilized,
nor accept for credit or exchange product that has been opened
but not used.
As long as the inner unit of the valve package is not opened or
damaged, the product is sterile.
Testing has shown that the following components
are nonpyrogenic:
• Valve and Valve with SIPHONGUARD
• Ventricular catheter (both BACTISEAL Catheters and non-
treated catheters)
• Distal catheter (both BACTISEAL Catheters and non-treated
catheters)
• Right angle adapter
• Priming adapter
Storage – BACTISEAL Catheters
Store any valve kits that contain BACTISEAL Catheters at
temperatures between 2°C (36°F) and 27°C (81°F), away from
direct light. Do not remove the product from the packaging until
it will be used. The shelf life of products containing BACTISEAL
Catheters is one year from the date of sterilization. The "Use
By" date is indicated on the labeling; the product can be used
through the last day of the month shown.
Pre-implantation Performance Testing
Every CERTAS Plus Programmable Valve is calibrated during
manufacture and is tested for proper performance.
Performing manometer testing is not recommended for the
following reasons:
• The concentration of antibiotics in the BACTISEAL Catheters
can be reduced by the testing.
• Customer-performed testing is susceptible to environmental
factors.
• The results yielded are not physiologic in nature.
If the surgeon insists upon performing manometer testing for
confirmation of valve closing pressures, please see Optional
Manometer Testing in Appendix A.
Instructions for Use
Note: Additional training materials are available from your local
Integra sales representative.
Surgical Procedure Precautions
• Silicone has a low cut and tear resistance; therefore, exercise
care when placing ligatures so as not to tie them too tightly.
The use of stainless steel ligatures on silicone rubber is not
recommended.
• Do not use sharp instruments when handling the silicone
valve or catheter; use shod forceps. Cuts or abrasions
from sharp instruments might rupture or tear the silicone
components.
• Do not fold or bend the valve during insertion. Folding or
bending might cause rupture of the silicone housing, needle
guard dislodgement, or occlusion of the fluid pathway.
• Verify proper placement and integrity of ligatures at all
tubing junctions to prevent obstruction of the catheter
lumen and tears or abrasions of the silicone tubing.
• Exercise extreme care to prevent the silicone components of
the system from coming in contact with towels, drapes, talc,
or any linty or granular surfaces. Silicone rubber is highly
electrostatic and, as a result, attracts airborne particles and
surface contaminants that could produce tissue reaction.
• Do not immerse the BACTISEAL Catheter in antibiotic
solutions. Only use sterile water or normal saline to
immerse the BACTISEAL catheter as other solutions are not
recommended and may cause precipitation and consequent
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