Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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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.
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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.
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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.
•
Nalu Neurostimulation System external components are not allowed in MRI system room. These
components include Therapy Discs (Model 34001 or Model 34002), the iOS or Android device with the Nalu
Remote Control application, Charger, Clinician Programmer and Belts, surgical instruments or accessories.
All such parts are
MR Unsafe
and are not be permitted in the MRI system room.
•
Do not perform MRI on a patient undergoing the trial phase of the Nalu Implantable Pulse Generator (i.e.
the patient has a percutaneously implanted lead and an external Trial Therapy Disc (Model 34002).
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Do not perform MRI on a patient that has any other active medical implants.
•
No parts of the implanted Nalu Neurostimulation System may be within the transmit/receive RF head
coil.
Preparation of the Patient Prior to the MRI Examination
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Inform the patient of the risks associated with undergoing an MRI examination: an MRI exam performed
outside recommended guidelines may result in the electromagnetic fields used with MRI technology
interacting adversely with an implanted Nalu Neurostimulation System, potentially injuring the patient and/or
damaging the device.
•
A trained healthcare professional with the proper knowledge of MRI technology such as an MRI safety-
trained radiologist, MRI technologist, MRI nurse, or MRI physicist must ensure that the MRI examination
will be conducted according to the information presented in this document.
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Document the patient’s programming parameters.
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Perform an impedance check. Do not perform an MRI if the impedance is greater than 10 kΩ.
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Remove the Therapy Disc from the patient before entering the MRI system room.
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Do not conduct an MRI examination if the 40 cm implanted lead(s) are not connected to the Nalu
Implantable Pulse Generator.
•
If possible, do not sedate or anesthetize the patient so that the patient can inform the MRI system operator
of any unusual sensations or problems associated with the MRI examination.
•
Instruct the patient to immediately inform the MRI system operator if any discomfort, stimulation, shocking,
or heating is experienced during MRI.
Considerations during the MRI Examination
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Similar to other MRI examinations, carefully monitor the patient throughout the MRI procedure both visually
and audibly. Immediately discontinue the MRI examination if the patient reports any problems or unusual
sensations.
Considerations after the MRI Examination
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After the patient leaves the MRI system room, turn the Therapy Disc on and verify connection to the
Implantable Pulse Generator.
•
Perform an impedance check.
