Integra Codman CERTAS Plus Manual Del Usario página 21

• 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
adverse effects (e.g., catheter occlusion, hydrocephalus).
Keep the time the BACTISEAL catheter is immersed in
sterile water or normal saline to a minimum (i.e., seconds)
to reduce the risk of introducing infectious agents. 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: SIPHONGUARD 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.
3 . Once fluid flows from the distal connector barb of the valve
(or the distal catheter, on unitized models), and air has
been evacuated from the valve, remove the syringe and the
priming adapter (if used).
Surgical Technique
There are a variety of surgical techniques that can be used to
place the valves. The surgeon should choose in accordance with
his or her own clinical experience and medical judgment. It is
required that the valve be irrigated as outlined in Irrigation, to
help ensure proper performance.
CAUTION: Placement of the valve can impact the performance of
the tool kit and should be taken into account for proper patient
therapy . Select a location where the implanted valve can be
positioned for use with the tool kit . Avoid placement too close
to structures, such as the ear . It is also important to choose an
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