COOK Medical Evolution Instrucciones De Uso página 8

- a maximum whole body average specific absorption rate (SAR)
of 2.9 W/kg (corresponding to a calorimetry measured value of
2.1 W/kg) for 15 minutes of MR scanning in a 1.5 Tesla Magnetom
(Siemens Medical Solutions, Malvern, PA, Software Numaris/4) MR
scanner.
- a maximum whole body average specific absorption rate (SAR) of
2.9 W/kg (corresponding to a calorimetry measured value of
2.7 W/kg) for 15 minutes of MR scanning in a 3.0 Tesla Excite (GE
Electric Healthcare, Milwaukee, WI, Software 14X.M5) MR scanner.
Image Artifacts
MR image quality may be compromised if the area of interest is within
the lumen of the Evolution Stent or within approximately 6 mm of the
position of the Evolution Stent as found during non-clinical testing
using the sequences: T1-weighted, spin echo pulse sequence and
Gradient echo pulse sequence in a 3.0 Tesla Excite (GE Electric Healthcare,
Milwaukee, WI, Software 14X.M5) MR system with body radiofrequency
coil. 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 duodenal 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.
Cook recommends that the patient register the MR conditions disclosed
in this IFU with the MedicAlert Foundation. The MedicAlert Foundation
can be contacted in the following manners:
Mail: MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
Phone: 888-633-4298 (toll free)
209-668-3333 from outside the US
Fax: 209-669-2450
Web: www.medicalert.org
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