Artifact Information - MedComp DIGNITY Instructions D'utilisation

MR Conditional - 3 Tesla (artifacts may present imaging
problems if MRI area of interest is on or near area where
MR
device is located)
Report Conclusion: MRI Information
MR Conditional
The Implantable Vascular Access Port was determined to be MR-conditional.
Non-clinical testing demonstrated that the Implantable Vascular Access Port is
MR Conditional. A patient with this device can be scanned safely immediately
after placement under the following conditions:
Static Magnetic Field
-Static magnetic field of 3-Tesla or less
-Maximum spatial gradient magnetic field of 720-Gauss/cm or less
MRI-Related Heating
In non-clinical testing, the Implantable Vascular Access Port produced the
following temperature rise during MRI performed for 15-min of scanning (i.e.,
per pulse sequence) in the 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software
14X.M5, General Electric Healthcare, Milwaukee, WI) MR system:
Highest temperature change +1.8˚C
Therefore, the MRI-related heating experiments for the Implantable Vascular
Access Port at 3-Tesla using a transmit/receive RF body coil at an MR system
reported whole body averaged SAR of 2.9 -W/kg (i.e., associated with a
calorimetry measured whole body averaged value of 2.7-W/kg) indicated that
the greatest amount of heating that occurred in association with these specific
conditions was equal to or less than +1.8˚C.

Artifact Information

MR image quality may be compromised if the area of interest is in the exact
same area or relatively close to the position of the Implantable Vascular Access
Port. The maximum artifact size (i.e., as seen on the gradient echo pulse
sequence) extends approximately 45-mm
to the size and shape of this device during MR imaging (3-Tesla/128-MHz,
Excite, HDx, Software 14X.M5, transmit/receive RF body coil, General Electric
Healthcare, Milwaukee, WI). Therefore, optimization of MR imaging parameters
to compensate for the presence of this device may be necessary.
Pulse
Sequence
Signal Void
Size
Plane
Orientation
T1-SE T1-SE
2,759-mm 601-mm
2
Parallel Perpendicular
(for worst case scenario) relative
2
GRE
4,480-mm
2
Parallel
-12-
GRE
3,966-mm
2 2
Perpendicular