Detailed Product Description; Codman Certas Plus Programmable Valve; Siphonguard Device - DePuy Synthes Codman Neuro CERTAS Plus Manual Del Usario

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MRI-Related Heating
In non-clinical testing, the CODMAN CERTAS Plus
Programmable Valve produced the following temperature
rise during MRI performed for 15-min of scanning
(i.e., per pulse sequence) in a 3-Tesla MR system
(3-Tesla/128-MHz, EXCITE, HDx, Software 14X.M5,
General Electric Healthcare, Milwaukee, WI):
MR system reported,
whole body averaged SAR
Calorimetry measured values,
whole body averaged SAR
Highest temperature change
Temperature scaled to whole
body averaged SAR of 4-W/kg 2.3°C
Artifact Information
The maximum artifact size as seen on the gradient echo
pulse sequence at 3-Tesla extends approximately 25-mm
relative to the size and shape of the CODMAN CERTAS
Plus Programmable Valve.
Specific Guidelines
The valve setting should be verified after the MRI
procedure (See Section C: Post-implantation Adjustment
Procedure Steps 1 through 6).

Detailed Product Description

CODMAN CERTAS Plus Programmable Valve

The valve features an adjustable mechanism and an
inline reservoir. All valves are marked with a radiopaque
direction-of-flow arrow and a right hand side (RHS)
marker. A priming adapter is included with all valves.
Valves are available with or without a SIPHONGUARD
Device. Valves are also available with or without
accessories, including silicone catheters or BACTISEAL
Catheters. See Figure 1.
The valves are designed for use with catheters having
the following dimensions:
Component
Ventricular catheter
Distal catheter

SIPHONGUARD Device

The SIPHONGUARD Device is supplied with some
models of the valve. CSF flows through the valve and
enters the SIPHONGUARD Device, where it flows into
two internal passages. Under normal conditions, the
majority of CSF flows through a central ruby ball and
cone valve, and exits directly out of the distal port of
the SIPHONGUARD Device. The remaining CSF travels
through a spiral passage that surrounds the central
passage, distal to the ball and cone valve.
206521-001-G-INS.indd 8
Note: The highest SG magnetic field is commonly
located off-axis, at a side wall, and near the opening
of the bore of the scanner. Please refer to MRI
manufacturers published value and location of the
peak SG that is accessible to the patient.
Maximum MR system reported, whole body
averaged specific absorption rate (SAR) of 4-W/kg
for 15 minutes of scanning (i.e., per pulse sequence)
in the First Level Controlled Operating Mode of
operation for the MR system.
2.9-W/kg
2.7-W/kg
1.7°C
Inner
Diameter
1.4 mm
1.0 mm
8
Outer
Diameter
2.7 mm
2.2 mm
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