13
9.
Return all tools to the storage case to prevent damage.
Note:
fully collapse the Adjustable Height Locator
Tool (See Figure 2B).
SECTION B: 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. When immersing the catheter
in sterile water or saline, keep immersion time to a
minimum. A pale orange color might be imparted to
the immersion solution. Manometer testing of the
valve with BACTISEAL Catheter is not advised.
Irrigation
It is required that the valve be irrigated before
implantation to help ensure proper performance.
1.
Hold the valve vertically with the
distal connector
barb pointing downward.
2.
Using a syringe, slowly and gently fill the entire valve
system with pyrogen-free, sterile saline solution or,
for catheters other than BACTISEAL Catheters, an
appropriate antibiotic solution. Once fluid begins
flowing through the valve mechanism, the distal
connector barb of the valve can be pointed upward to
assist in evacuating air from the system.
Note:
A priming adapter with inlet tubing is provided
to facilitate irrigation.
CAUTION: Do not fill, flush, or pump the valve with
fluid in which cotton, gauze, or other lint-releasing
material has been soaked.
Note:
More pressure might be required on the syringe
before fluid starts flowing through the valve mechanism.
This is normal and will only occur during initial irrigation
of the valve. A popping sound may occur.
Note:
The SIPHONGUARD device is intended to
reduce the rapid flow of CSF. It also reduces the
ability to prime the shunt system during implantation
to a rate of approximately 0.5 mL/minute.