Detailed Product Description; Codman Certas Plus Programmable Valve - Codman CERTAS Plus Manual Del Usario

Tabla de contenido

Idiomas disponibles

CAUTION: Do not use the CODMAN CERTAS Tool Kit

in the MR suite.

MR Conditional

The CODMAN CERTAS Plus Programmable Valve

is MR Conditional. Non-clinical testing demonstrated

that the CODMAN CERTAS Plus Programmable Valve

is MR Conditional. A patient with this device can be

scanned safely, immediately after placement under the

following conditions:

•

Static magnetic field of 3-Tesla and 1.5-Tesla

•

Maximum spatial gradient magnetic field of

1,000 Gauss/cm (extrapolated) or less.

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.

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 1.5-Tesla system

1.5-T/63.86 MHz, MITS 1.5, Software MITS 1.2.1,

Zurich Med Tech:

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 2.6°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).