Contraindications - Integra Codman CERTAS Plus Mode D'emploi

When tested with a 120 cm long, 1 mm ID Distal Catheter the
average pressure increase is dependent on flow rate as shown
here:
5 mL/h
20 mL/h
50 mL/h
Intraventricular pressure is maintained at a constant level by
the ball and cone valve seat design. The ball is manufactured
of synthetic ruby, as is the matching cone. Together these
components provide a precise fit for regulating the flow of CSF
through the valve.
SIPHONGUARD
designed to prevent excessive drainage of CSF by the shunt
system. Excessive draining can be induced by a rapid increase
in hydrostatic pressure created by the elevation of the shunt
ventricular catheter with respect to the shunt distal catheter (i.e.,
when patient moves from a supine to an upright position). Graph
2 describes the pressure-flow performance characteristics of the
valve with SIPHONGUARD.
Graph 2
The BACTISEAL
valve, are subjected to a treatment process by which the silicone
is impregnated with rifampin and clindamycin hydrochloride.
The BACTISEAL Silicone Catheters have been shown to reduce
the colonization of gram positive bacteria on the tubing surface.
A CERTAS Tool Kit must be used to adjust the valve setting. It
can also be used to confirm the setting. CERTAS Tool Kits are
available separately (see Tool Kit Instructions for Use for more
information).
Indications
The CERTAS Plus Programmable Valve is an implantable device
that provides constant intraventricular pressure and drainage of
CSF for the management of hydrocephalus.

Contraindications

These devices are contraindicated in patients receiving
anticoagulants or known to have a bleeding diathesis.
Avoid shunt implantation if infection is present within the body.
Delay the shunt procedure when infections such as meningitis,
ventriculitis, peritonitis, bacteremia, and septicemia are present.
The BACTISEAL Catheters are contraindicated in patients with
known hypersensitivity to rifampin or clindamycin hydrochloride.
Warnings
• Choose an implantation site for the valve where the tissue
over the valve is not too thick (i.e. tissue thickness <10
mm). Otherwise locating, reading, and adjusting the valve
with the tool kit may be difficult (i.e. multiple attempts may
6 mmH
21 mmH
50 mmH
, included in some models of the valve, is
®
Additional Pressure Needed to Maintain Flow [mmH
Catheters, included in some models of the
®
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EN – ENGLISH
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