Integra Codman CERTAS Plus Mode D'emploi page 5

• Inspect the 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 sales representative for a replacement kit.
• 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). If it is used in a
residential environment (for which CISPR 11 class B is normally required)
this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation
measures, such as relocating or re-orienting the equipment.
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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