Mri Information - Taewoong Niti-S Tracheal Uncovered Stent Manual Del Usuario

MRI Information

Niti-S stent was determined to be MR-conditional.
Non-clinical testing demonstrated that the Niti-S stent is MR
Conditional according to ASTM F2503. 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, Niti-S stent produced the following
temperature rises during MRI performed for 15-min of scanning
(i.e., per pulse sequence) in 1.5-Tesla/64-MHz (Magnetom,
Siemens Medical Solutions, Malvern, PA. Software Numaris/4,
Version Syngo MR 2002B DHHS Active-shielded, horizontal
field scanner) and 3-Tesla (3-Tesla/128-MHz, Excite, HDx,
Software 14X.M5, General Electric Healthcare, Milwaukee, WI)
MR systems:
MR system reported, whole body
averaged SAR
Calorimetry measured values, whole
body averaged SAR
Highest temperature change
These temperature changes will not pose a hazard to a human
subject under the conditions indicated above.
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 Niti-S
stent. Therefore, optimization of MR imaging parameters to
compensate for the presence of this device may be necessary. The
maximum artifact size (i.e., as seen on the gradient echo pulse
sequence) extends approximately 10-mm relative to the size and
shape of this implant.
Pulse
Sequence
Signal
Void Size
Plane
Orientation
MR Conditional
T1-SE
2
7,695-mm
Parallel
1.5-Tesla
2.9-W/kg
2.1-W/kg
+1.9°C
T1-SE GRE
2
676-mm 7,984-mm
Perpendi
Parallel
cular
3-Tesla
2.9-W/kg
2.7-W/kg
+2.4°C
GRE
2 2
977-mm
Perpendi
cular