Integra Codman CERTAS Plus Mode D'emploi page 21

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
implantation site where the tissue over the valve is not too thick
(>10 mm) otherwise locating, reading and adjusting with the
CERTAS Tool Kit may not be possible .
It is recommended to record the setting of the valve in the
patient records and on the patient I.D. wallet card. Labels are
provided with each valve to record the product lot number
information in the patient records. I.D. wallet cards are available
from the local Integra sales representative.
Troubleshooting
If valve function is adversely affected by accumulations of
biological matter, it might be possible to dislodge the material
and restore proper function through one of the following
methods:
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