Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
Page
35
of
44
The Nalu Neurostimulation System is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or user of the Nalu Neurostimulation System can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the System.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12 m
0.12 m
0.45 m
0.1
0.37 m
0.37 m
1.41 m
1
1.17 m
1.17 m
4.47 m
10
3.70 m
3.70 m
14.12 m
100
11.70 m
11.70 m
44.65 m
MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION (SCS)
All of the components of the Nalu Neurostimulation System are MR Unsafe except for the following
:
•
Nalu Implantable Pulse Generators (Dual Integrated Model 11002-040, Single Integrated Model 11001-
040)
•
Nalu Implantable Pulse Generators (Dual Ported Model 11004-002 connected to two 40 cm Nalu Lead
Model 12001-040, Single Ported Model 11003-002 connected to a 40 cm Nalu Lead Model 12001-040)
•
Nalu Anchor (Model 13001).
WARNING
Do not bring MR Unsafe components of the Nalu Neurostimulation System into the MRI system
room.
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
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).
