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800581-2.11 NeurOne System User Manual.doc
MRI Information
Non-clinical testing has demonstrated the NeurOne Tesla amplifier,
battery pack, Bipolar Connection Box and MRI cap accessories are MR
conditional. MR Conditional system parts are labeled with MR
Conditional symbol.
MR Conditional system parts are for INVESTIGATIONAL USE ONLY!
Static Magnetic Field
Based on non-clinical testing the above devices can be scanned safely in a MR environment
under the following
Static magnetic field of 3 Tesla only
Spatial gradient field of 253 T/m (25.300 gauss/cm) and less
Spatial gradient field product of 684 T2/m and less
Theoretically estimated maximum whole body averaged (WBA) specific absorption
rate (SAR) of < 2 W/kg at 3 Tesla, (related to 2.3°C temperature increase) for 15
minutes of continuous MR scanning.
The following MRI scanner has been used in non-clinical testing:
Siemens Trio 3T
Siemens Prisma 3T
Philips Achieva 3.0 tx
Maximum duration of single scan based on non-clinical testing: 15 min of EPI