Contraindications; Warnings - DePuy Synthes Codman Neuro CERTAS Plus Manual Del Usario

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 CODMAN CERTAS Plus Programmable Valve is
contraindicated for drainage to the atrium.
The BACTISEAL Catheters are contraindicated in
patients with known hypersensitivity to rifampin or
clindamycin hydrochloride.

Warnings

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206521-001-G-INS.indd 5
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 be required) or
impossible. If unable to adjust the valve, the valve
will maintain a constant operating pressure and the
patient should be informed of this risk. Please refer
to SECTION D: Troubleshooting should any difficulty
in programming occur.
As with all programmable valves, the magnets within
the CERTAS Plus valve will cause an image artifact
on CT and MRI imaging. As a result, the implantation
site should be chosen so that the artifact will be
minimized in areas of significant clinical interest,
such as a tumor, that may require repeated future
imaging assessment.
Testing shows that the valve mechanism is resistant
to unintended changes in the setting in a 3 Tesla
MRI. However, the clinician should confirm the valve
setting after a magnetic resonance imaging (MRI)
procedure. See SECTION C: Post-implantation
Adjustment Procedure Steps 1 through 6.
The valve setting is adjusted with the application
and manipulation of strong magnets. A change to
the valve setting is unlikely to occur under normal
circumstances. However, magnetic fields should not
be placed in close proximity to the valve due to the
possibility of an unintentional setting change.
Read MRI Information before performing an MRI
procedure on a patient implanted with the valve.
Any magnet may experience a degradation of
magnetic field strength as a consequence of
exposure to the significantly stronger magnet field
induced in an MRI procedure.
Based on the coercivity of the CERTAS Plus
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magnet material, the valve is resistant to magnetic
degradation in a 1.5T MRI.
Testing of the CERTAS Plus valve following
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exposure to 10 simulated MRI procedures at 3T
indicates there is no substantial demagnetization
or significant reduction in programmability. Please
refer to SECTION D: Troubleshooting should any
difficulty in programming occur.
Do not interchange the CODMAN CERTAS
Tool Kit (82-8851) components with the
CODMAN CERTAS Therapy Management System
TMS (82-8850) components.
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