Integra Codman CERTAS Plus Manual Del Usario página 22

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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:
• flushing and/or pressing the valve (only for those valves
without the SIPHONGUARD feature)
• multiple attempts to adjust the setting
Confirming the Current Valve Setting
The setting of an implanted valve can be determined by
using the CERTAS Tool Kit, (refer to the Tool Kit IFU for more
information).
An alternate method is to x-ray the valve. A proper x-ray is
generated when the film is shot perpendicular to the plane of the
valve with the non-implanted side of the patient's head resting on
the plate. The film must be taken in relation to the valve and not
the patient's anatomy. See Figure 3 for x-ray views of the valve at
each setting.
When viewing the x-ray film or screen to confirm the valve
setting, use the X-Ray Overlay Tool (refer to the Tool Kit IFU for
more information).
Reading the Valve Setting with the X-Ray Overlay Tool
See Figure 4.
Note: Position the X-Ray Overlay Tool flush against the x-ray
image.
1 . Align RED centerline of valve on overlay with the centerline
of the valve x-ray under review. This can be accomplished
by aligning the proximal and distal connectors of the x-ray
image with those on the overlay.
2 . Ensure that the numbers on the overlay that depict the
performance settings are properly oriented for viewing. In
this orientation the right-hand side (RHS) marker red line
extends to the right of the RED centerline. This ensures
proper overlay orientation.
3 . Align rotating construct (RC) center dot on overlay with the
center of the RC of the x-ray image.
4 . Ensure RHS marker red line containing red dot is aligned with
the RHS marker of the x-ray image (if present).
5 . The valve setting is determined by identifying the region of
the overlay that contains the majority of the image of the
magnet that has the tantalum ball adjacent to it.
Injection
If hypodermic injection is required, inject with a 25-gauge or
smaller non-coring HUBER
The reservoir can be punctured up to 25 times with a 25-gauge or
smaller non-coring HUBER type needle.
CAUTION: A needle guard has been included in the valve
housing to provide tactile feedback during needle insertion but
is not intended to prevent puncturing through the back of the
valve under forceful pressure .
type needle into the reservoir only.
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