Integra CODMAN CERTAS Plus Manual page 5

• 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
• The valve setting should be confirmed after an MR procedure.
• Excessive swelling may make it difficult to determine and/or adjust the
setting. If difficulty correctly positioning the Locator persists, wait until
the swelling is reduced. X-ray may be used to confirm the valve setting.
• Failure to accurately position the Locator 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
Locator). 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.
• The emissions characteristics of this equipment make it suitable for use
in industrial areas and hospitals (CISPR11 class A).
Adverse Events
Accumulation of biological matter within the valve can cause difficulties
adjusting the valve setting and impair the anti-reflux function.
Adjusting the valve to a performance setting that is lower than necessary can
lead to excessive CSF drainage, which can cause subdural hematomas and
slit-like ventricles.
Magnetic Resonance Imaging (MRI) Safety Information
MR Unsafe
CAUTION: Do not use the CERTAS Plus Electronic Tool Kit in the MR suite.
Disinfecting the CERTAS Plus Electronic Tool Kit
The CERTAS Plus Electronic Tool Kit is provided as a non-sterile product.
After use, wipe the surfaces of the Tool Kit components that touch the patient
with a 70% Isopropyl wipe. Follow Steps 1 through 4 below.
1. Thoroughly wet the surfaces with a wipe.
2. Keep the surfaces wet for 2 minutes. Use as many wipes as needed to
keep the surfaces wet for the entire 2 minutes.
3. Allow the wetted surfaces to air dry.
4. Inspect the components to ensure that all soil, blood, or debris has
been removed. If needed, repeat Steps 1 through 3 and inspect again.
CAUTION: Do not sterilize the Tool Kit.
O.
2
The Tool Kit is considered "MR Unsafe" in accordance with
the American Society for Testing and Materials (ASTM)
Standard F2503-13.
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