Precautions
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Adverse Events
Devices for shunting CSF might need to be replaced at
any time due to medical reasons or failure of the device.
Keep patients with implanted shunt systems under close
observation for symptoms of shunt failure.
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• 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.
Inspect the sterile package carefully. Do not use if:
the package or seal appears damaged,
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contents appear damaged, or
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the expiry date has passed.
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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.
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
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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
incorrect number may appear in the window of the
Indicator Tool). The Locator Tool must be precisely
aligned with both the valve's direction of flow and the
center of the hard valve mechanism for an accurate
indication reading. Alignment can be more challenging
if tissue thickness is >10 mm above the valve. In
these instances, verify the valve setting with x-ray or
fluoroscopy. See SECTION D: Troubleshooting and
SECTION E: Confirming the Current Valve Setting.
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