Precautions - Codman CERTAS Plus Manual Del Usario

• The Indicator Tool has a precise operating

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
o
alternative 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
o
malformations of the cardio-pulmonary system
in children, VA distal catheter location is more
o
crucial for 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
Confirm the valve performance setting after an
•
MR procedure.
Use only the CODMAN CERTAS Tool Kit to adjust
•
the setting of the CODMAN CERTAS and CODMAN
CERTAS Plus Programmable Valves.
Do not use any of the CODMAN CERTAS Tool Kit
•
components on a metal surface, such as a Mayo stand
as this could interfere with the Indicator Tool magnets.
Note: The Adjustment Tool contains powerful magnets.
Inspect the CODMAN CERTAS Tool Kit components
•
before each use. Check for damage, such as cracks.
Do not use the Tool Kit if damage is present. Contact
your local Codman sales representative for a
replacement kit.
Excessive swelling may make it difficult to
•
determine and/or adjust the performance setting.
See Step 4 in SECTION C: Post-Implantation
o
Adjustment Procedure for instructions for using
the Low Profile Locator Tool in these instances.
If difficulty correctly positioning both Locator
o
Tools persists, wait until the swelling is reduced
or confirm the valve setting with x-ray. See
SECTION E: Confirming the Current Valve
Setting for more information.
Failure to accurately position the Locator Tool could
•
result in an inaccurate indication of the performance
setting, potentially leading to a false reading (i.e. an
mechanism and is vulnerable to damage if
mishandled. Store and carry all components of
the Tool Kit in the storage case when not in use
to prevent damage. Replace the Indicator Tool
immediately if dropped (or suspected of being
dropped) to ensure accurate performance.
Replacement Indicator Tools are available from
your local Codman representative.
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