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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. (see Tool Kit
Instructions for Use for more information).
•
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.
•
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 near 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 magnet
o
material, the valve is resistant to magnetic degradation in
a 1.5T MRI.
Testing of the CERTAS Plus valve following exposure to
o
10 simulated MRI procedures at 3T indicates there is no
substantial demagnetization or significant reduction in
programmability. Please refer to the Tool Kit IFU if any
difficulty in programming occurs.
Precautions
•
Inspect the sterile package carefully. Do not use if:
the package or seal appears damaged,
–
contents appear damaged, or
–
the expiry date has passed.
–
•
Use sterile technique in all phases of handling the valves
and accessories.
•
Use only with catheters that are compatible with the
dimensions shown in the Detailed Product Description
section.
•
Ventriculoatrial (VA) shunting could be considered in
patients when:
peritoneal CSF absorption is impeded and alternative
o
sites for shunting are necessary
the patient presents with peritoneal adhesions,
o
pseudocysts or dialysis catheters
•
Surgeons should consider the additional risks and benefits
prior to considering a VA shunt:
in patients with cardiopathies or other malformations of
o
the cardio-pulmonary system
in children, VA distal catheter location is more crucial for
o
proper function, since rapid growth may cause cephalad
migration of the tip over time
•
The safety and effectiveness of Bactiseal catheters for VA
shunting has not been established.
•
Carefully monitor the patient during the first 24 hours after
adjusting the valve setting. It is recommended that each
adjustment be limited to an increase or a decrease of one
setting, since setting changes can range between 15 and
50 mmH
O.
2
•
The valve setting should be confirmed after an MR procedure.
•
Use only a CERTAS Tool Kit to adjust the setting of the
CERTAS and CERTAS Plus Programmable Valves.
4
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