Integra Codman CERTAS Plus Mode D'emploi page 18

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• MRI scan duration shall not exceed 15 minutes of continuous
scanning
• Only use Transmit / Receive RF Body coil or Transmit RF Body
coil / Receive-only RF Head coil. WARNING: Do not use
Transmit / Receive or Transmit-only RF Head coils.
• WARNING: Do not use Transmit / Receive or Transmit-only
local coils that are placed directly over the location of valve.
• Patient does not have elevated body temperature or
compromised thermoregulation at time of scan.
Under the scan conditions defined above, the CERTAS Plus
Programmable Valve is expected to produce a maximum
temperature rise of approximately 2.8±0.21°C in the 1.5T MR
environment and 3.36±0.26°C in the 3T environment after 15
minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device
extends approximately 25 mm from the CERTAS Plus Valve when
imaged with a gradient echo pulse sequence and a 3T MRI System.
MRI Additional Information
Please refer to MRI manufacturer's published value and location
of the peak magnetic field spatial gradient in patient-accessible
areas.
Maximum MR system reported, whole body SAR of
4-W/kg determined with 15 minutes of scanning (i.e., per pulse
sequence).
Specific Guidelines
The valve setting should be verified after the MRI procedure.
Detailed Product Description
CERTAS Plus Programmable Valve
The valve features an adjustable mechanism and a 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
SIPHONGUARD. Valves are also available with or without
accessories, including silicone catheters or BACTISEAL Catheters
(see Figure 1).
Programmable Valve Configurations
Inline with SIPHONGUARD
Inline
Inline Small with SIPHONGUARD
Inline Small
Right Angle with SIPHONGUARD
Right Angle
The valves are designed for use with catheters having the
following dimensions:
Component
Ventricular catheter
Distal catheter
SIPHONGUARD
SIPHONGUARD is supplied with some models of the valve. CSF
flows through the valve and enters SIPHONGUARD, where it
flows into two internal passages. Under normal conditions, most
of the CSF flows through a central ruby ball and cone valve,
Inner
Diameter
1.4 mm
1.0 mm
6
Outer
Diameter
2.7 mm
2.2 mm