Storage - Bactiseal Catheters; Pre-Implantation Performance Testing; Instructions For Use; Section A: Pre-Implantation Adjustment Procedure - Codman CERTAS Plus Manual Del Usario

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.
Codman Neuro 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 Device
• 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 CODMAN 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 Codman sales representative.
SECTION A: Pre-implantation
Adjustment Procedure
Adjust the performance setting before implanting
the CERTAS Plus Programmable Valve. This step is
performed before the sterile inner package is opened.
1. Place the valve sterile package on a non-metallic
surface so the clear portion of the package faces up.
Place the Adjustable Height Locator Tool in the
circular grooves of the package so that the arrow on
the tool points in the same direction as the arrows
molded into the plastic package (See Figure 3).
Ensure that the Adjustable Height Locator
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