COOK Medical Evolution EVO-20-25-8-E, Инструкция по эксплуатации

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magnetic field pertinent to the patient (i.e., outside of scanner covering,
accessible to a patient or individual).
MRI-Related Heating
• 1.5 and 3.0 Tesla Systems: It is recommended to scan in normal
operation mode (whole body averaged specific absorption rate (SAR) =
2.0W/kg) (“Normal Operating Mode” is defined as the mode of operation
of the MR system in which none of the outputs have a value that cause
physiological stress to the patient) for 15 minutes of scanning (i.e., per
scanning sequence).
1.5 Tesla Temperature Rise
In non-clinical testing, the Evolution® Colonic Stent produced maximum
temperature rises of 1.9 °C during 15 minutes of MR imaging (i.e., for one
scanning sequence) performed in a 1.5 Tesla MR System (Magnetom,
Siemens Medical Solutions, Malvern, PA, Software Numaris/4, Version
Syngo MR 2002B DHHS Active-shielded) at an MR system reported
whole-body-averaged SAR of 2.9 W/kg (associated with a calorimetry
measured whole body averaged value of 2.1 W/kg).
3.0 Tesla Temperature Rise
In non-clinical testing, the Evolution® Colonic Stent produced maximum
temperature rises of 2.7 °C during 15 minutes of MR imaging (i.e., for
one scanning sequence) performed in a 3 Tesla MR System (Excite, HDx,
General Electric Healthcare, Milwaukee, WI, Software 14X.M5) at an MR
system reported whole-body-averaged SAR of 2.9 W/kg (associated with
a calorimetry measured whole body averaged value of 2.7 W/kg).
Image Artifacts
MR image quality may be compromised if the area of interest is in
within the lumen or within approximately 3 mm of the position of the
Evolution® Colonic Stent, as found during non-clinical testing using the
sequence: T1-weighted, spin echo and gradient echo pulse sequence
in a 3.0 Tesla MR system (Excite, General Electric Healthcare, Milwaukee,
WI, Software 14X.M5). Therefore, it may be necessary to optimize MR
imaging parameters for the presence of this metallic stent.
Additional Information: The safety of performing an MRI procedure
in a patient with overlapping colonic stents or other MRI-conditional
device(s) in direct contact with this device has not been determined.
Performing MRI in such situations is not recommended.