Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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It is important to read this entire section prior to conducting or recommending an MRI examination on a user
implanted with the Nalu Neurostimulation System. These instructions only apply to the Nalu Neurostimulation
System and do not apply to other products. If you have any questions, please contact Nalu Medical or visit
www.nalumed.com.
MRI Safety Information
For Complete instructions, please visit
www.nalumed.com
and refer to the Nalu MRI Checklist.
MR Conditional
Nonclinical testing demonstrated that the Nalu Neurostimulation System (i.e., the
pulse generator and
leads) is MR Conditional. The implanted components of the Nalu Neurostimulation System that are MR
Conditional are, as follows: Pulse Generators (11001-040, 11002-040, 11003-002, 11004-002), 40 cm Lead
(12001-040) and Anchor (13001).
A patient with an implantable pulse generator, leads, and anchor can be scanned safety in an MRI system under
the following conditions:
•
Static magnetic field of 1.5 Tesla (T) or 3.0 T, only.
•
Maximum spatial field gradient of 1,900 gauss/cm (19 T/m).
•
15 minutes of continuous scanning in First level controlled mode for Transmit-receive and extremity and head coils
(Partial body SAR of the exposed body part of 10 W/kg and Head SAR of 3.2 W/kg).
•
No external components of the Nalu Neurostimulation system are permitted the MRI system room.
•
Do not perform MRI using the transmit/receive RF body coil of the transmit RF body coil with a receive-only
coil at 1.5 T or 3 T
•
For head/brain MRI examinations, only the transmit/receive RF head coil is permitted for use.
No parts of
the implanted Nalu Neurostimulation System may be within the transmit/receive RF head coil.
•
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
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 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.
Additional conditions for all MRI Examinations
•
Do not perform an MRI if the patient has a device or device component lead(s), extension, etc. attached to
the Nalu Implantable Pulse Generator or leads from a different manufacturer attached to the Nalu
