Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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Figure 2.
Extremity MRI examinations are permitted using a 1.5 T or 3 T MRI system and a transmit/receive RF
extremity coil (e.g., knee, foot/ankle, wrist). No part of the implanted Nalu Neurostimulation System may be within
the transmit/receive RF extremity coil. All other aforementioned conditions must be carefully followed.
(a)
Represents an MRI of the knee using a transmit/receive RF knee coil.
(b)
Represents an MRI of the foot or ankle
using a transmit/receive RF foot/ankle coil. (c) Represents an MRI of wrist using a transmit/receive RF wrist coil.
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
Implantable Pulse Generator. The risk of performing an MRI examination under those circumstances has
not been evaluated and, thus, may cause harm to the patient and/or the components.
•
A patient implanted with a Model 12001-040 40 cm lead(s) connected to a Model 11003-002 or Model
11004-002 Ported IPGs can undergo an MRI examination under the specified conditions. Do not perform
an MRI if the leads have been disconnected from the IPG.
•
A patient implanted with a Model 11001-040 or Model 11002-040 IPG with integrated lead(s) can undergo
an MRI examination under the specified conditions.
•
MRI is only permitted using an MRI system operating at 1.5 T/64 MHz or 3 T/128 MHz.
•
Use only a transmit/receive RF head coil or transmit/receive RF extremity coil (e.g., head/brain, knee,
foot/ankle, wrist). The risk of using other types of RF coils has not been evaluated for the Nalu
Neurostimulation System.
1.5 T or 3 T MR system
Transmit/receive RF
wrist coil
Patient implanted with Nalu
Neurostimulation System
Figure 2c
