11. Use of MRI
MR Conditional
Non-clinical testing demonstrated that this device is MR
Conditional. A patient with this device can be scanned
safely in an MR system under the following conditions:
・ Static magnetic field of 1.5 tesla or 3 tesla, only
・ M aximum spatial gradient magnetic field of 1,000
gauss/cm (10-T/m)
・ M aximum MR system reported, whole body
averaged specific absorption rate (SAR) of 2-W/kg
for 15 minutes of scanning (i.e., per pulse sequence)
in the Normal Operating Mode
Under the scan conditions defined, this device is
expected to produce a maximum temperature rise of
2.4°C after 15-minutes of continuous scanning (i.e., per
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