6
• The Indicator Tool has a precise operating
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.
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:
o
peritoneal CSF absorption is impeded and
alternative sites for shunting are necessary
o
the patient presents with peritoneal adhesions,
pseudocysts or dialysis catheters
• Surgeons should consider the additional risks and
benefits prior to considering a VA shunt:
o
in patients with cardiopathies or other
malformations of the cardio-pulmonary system
o
in children, VA distal catheter location is more
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
2
O.
•
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.
o
See Step 4 in SECTION C:
Post-Implantation
Adjustment Procedure
for instructions for using
the Low Profile Locator Tool in these instances.
o
If difficulty correctly positioning both Locator
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
