Adverse Events; Mri (Magnetic Resonance Imaging) Safety Information; Detailed Product Description - Codman 82-8851 Manual Del Usuario

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 C: Troubleshooting and SECTION D:
Confirming the Current Valve Setting.

Adverse Events

Accumulation of biological matter within the
valve can:
• cause difficulties adjusting the valve setting
with the Tool Kit
• impair the antireflux function
Adjusting the valve to a performance setting that
is lower than necessary can lead to excessive CSF
drainage, which can cause subdural hematomas,
slit-like ventricles, and in infants, sunken fontanels.
MRI (Magnetic Resonance Imaging)
Safety Information
The CODMAN CERTAS Tool Kit is considered
"MR Unsafe" in accordance with the American
Society for Testing and Materials (ASTM) Standard
F2503-13.
CAUTION: Do not use the CODMAN CERTAS
Tool Kit in the MR suite.

Detailed Product Description

The CODMAN CERTAS Tool Kit (see Figure 1A)
consists of five components:
• Adjustable Height Locator Tool
• Low Profile Locator Tool
• Indicator Tool
• Adjustment Tool
• X-Ray Overlay Tool
These components are packaged within a case
(see Figure 1B) that, when closed, will help
minimize the effect of the CODMAN CERTAS Tool
Kit magnets on other items.
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