How Supplied; Pre-Implantation Performance Testing - Integra Codman CERTAS Plus Manual Del Usario

EN – ENGLISH

How Supplied

The valve and its accessories are for SINGLE USE ONLY; DO
NOT RESTERILIZE . Integra single-use devices have not been
designed to undergo or withstand any form of alteration, such
as disassembly, cleaning, or re-sterilization, after a single patient
use. These devices are intended to come into contact with the
central nervous system and the ability does not currently exist
to destroy possible contaminates, such as Creutzfeldt-Jakob
Disease. Reuse might also compromise device performance and
any usage beyond the design intent of this single use device
might result in unpredictable use hazards or loss of functionality.
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.
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