IMMOBILIZER, DUAL LEG

MR Safe – an item that poses no known hazards in all MRI environments. Using the terminology, “MR Safe” items are non-conducting, non-metallic, and non-magnetic items such as a plastic Petri dish. An item may be determined to be MR Safe by providing a scientifically based rationale rather than test data.

MR Conditional – an item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. “Field” conditions that define the MR environment include static magnetic field strength, spatial gradient magnetic field, dB/dt (time rate of change of the magnetic field), radio frequency (RF) fields, and specific absorption rate (SAR). Additional conditions, including specific configurations of the item (e.g., the routing of leads used for a neurostimulation system), may be required.

MR Unsafe – An item that is known to pose hazards in all MRI environments. MR Unsafe items include magnetic items such as a pair of ferromagnetic scissors.