nalu 12001-040 User Instructions For Use page 65

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For extremity MRI examinations, only use a transmit/receive RF coil that includes a knee,
foot/ankle, or wrist transmit/receive RF coil. No part of the implanted Nalu Neurostimulation System
may be within one of these transmit/receive RF coils.
Under the scan conditions defined above, the Nalu Neurostimulation System is expected to
produce a maximum temperature rise of 2.5ºC after 15 minutes of continuous scanning (i.e., per
pulse sequence) when using one of the above types of transmit/receive RF coils at a maximum,
whole body averaged SAR of 2.0 W/kg.
In non-clinical testing, the image artifact caused by the Nalu Neurostimulation System extends
approximately 10 mm from this implant when imaged using a gradient echo pulse sequence and
a 3 T MRI system.
Important Note: An MRI examination performed outside these guidelines may result in the
electromagnetic fields used with MRI technology to interact adversely with an implanted Nalu
Neurostimulation System potentially injuring the patient and/or damaging the device. Due to the
risks of using MRI in a patient with an active implanted device, it is important to read, understand,
and comply with all instructions to prevent potential harm or injury to the patient and/or damage to
the device.
Acceptable 1.5 T/64-MHz or 3 T/128 MHz MRI Scenarios
Note the position of the implantable pulse generator (IPG) and leads relative to the
transmitted RF energy for each respective transmit/receive RF coil.
Nalu User's Kit Instructions for Use PN: MA-000007 Rev J
Page 65 of 80