MRI Safety Information:
Non-clinical testing demonstrated that the M6-C disc 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
- Maximum spatial gradient magnetic field of 4,000-Gauss/cm (40-T/m)
- Maximum 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, the M6-C disc is expected to produce a maximum temperature rise of 2.2°C after 15-minutes of continuous scanning (i.e., per pulse sequence). In non-clinical testing, the image artifact caused by the M6-C disc extends approximately 10-mm from this device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.