COOK Medical Evolution Instructions For Use Manual page 5

1.5 Tesla Systems
Static magnetic field of 1.5 Tesla
Spatial gradient field of ≤450 Gauss/cm
Normal operating mode (whole- body-
averaged specific absorption rate (SAR)
< 2 W/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 causes
physiological stress to the patient) for
15 minutes (i.e., per pulse sequence).
Non-clinical testing was conducted under the following conditions, and produced a
maximum temperature rise of 4.4 ˚C:
• a maximum whole body average specific absorption rate (SAR) of
3.8 W/kg (corresponding to a calorimetry measured value of 3.1 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
3.0 W/kg (corresponding to a calorimetry measured value of 2.8 W/kg) for 15 minutes of MR
scanning in a 3.0 Tesla Excite (GE Electric Healthcare, Milwaukee, WI, Software G3.0-052B) MR
scanner.
MR image quality may be compromised if the area of interest is within the lumen of the
Evolution Stent or within approximately 7 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 G3.0-052B) MR system with body radiofrequency coil. Therefore, it may be
necessary to optimize MR imaging parameters for the presence of this metallic implant.
The safety of MR imaging using a local transmit/receive RF coil in areas immediately
adjacent or directly involving the implant has not been established and is therefore not
recommended.
The safety of performing MRI imaging in patients with overlapping stents or other device(s)
in the esophagus has not been established and is therefore 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:
3.0 Tesla Systems
Static magnetic field of 3.0 Tesla
Spatial gradient field of ≤720 Gauss/cm
Normal operating mode (whole- body-
averaged specific absorption rate (SAR)
< 2 W/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 causes
physiological stress to the patient) for
15 minutes (i.e., per pulse sequence).
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