MedComp Dignity Titanium Gebrauchsanleitung Seite 13

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MR Conditional - 3 Tesla (artifacts may present imaging
MR
problems if MRI area of interest is on or near area where
device is located)
Report Conclusion: MRI Information
MR Conditional
The Titanium Port was determined to be MR-conditional.
Non-clinical testing demonstrated that the Titanium 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 Titanium 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 Titanium 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 Titanium Port. The maximum artifact
size (i.e., as seen on the gradient echo pulse sequence) extends approximately
45-mm (for worst case scenario) relative to the size and shape of this device during
2
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
Medcomp® WARRANTS THAT THIS PRODUCT WAS MANUFACTURED ACCORDING TO APPLICABLE
STANDARDS AND SPECIFICATIONS. PATIENT CONDITION, CLINICAL TREATMENT, AND PRODUCT
MAINTENANCE MAY EFFECT THE PERFORMANCE OF THIS PRODUCT. USE OF THIS PRODUCT
SHOULD BE IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED AND AS DIRECTED BY THE
PRESCRIBING PHYSICIAN.
Because of continuing product improvement, prices, specifications, and model availability
are subject to change without notice. Medcomp
or contents in accordance with all relevant regulatory requirements.
Triniflex
is a registered trademark of Medical Components, Inc.
®
Does not contain DEHP.
Implantable Infusion Port Patient Guide and/or CT Guide
®
Sales Representative for more information about any
®
T1-SE T1-SE
2,759-mm 601-mm
2
Parallel Perpendicular
GRE
4,480-mm
2
Parallel
WARRANTY
reserves the right to modify its products
®
-11-
GRE
3,966-mm
2 2
Perpendicular