Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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a. Remove the Therapy Disc from the CT scan range.
b. Minimize X-ray exposure to the implanted device by:
c. Using the lowest possible X-ray tube current consistent with obtaining the required image quality.
d. Making sure that the X-ray beam is not placed over the Nalu Implantable Pulse Generator for more
than a few seconds.
2. After CT scanning directly over the implanted device:
a. Place the Therapy Disc on body/connect the Trial Therapy Disc and turn on stimulation.
b. Check for proper stimulation, and that indicator lights are operating as expected.
c. Shut off the Therapy Disc if it is suspected that the device is not functioning properly.
Radiofrequency (RF) Ablation
—Safety has not been established for RF ablation in users with the device. RF
ablation may result in heating and tissue damage. Do not use RF ablation anywhere near the device. If RF ablation
is used, ensure that ablation is not performed over or near the device.
Medical Devices/Therapies
— The following medical therapies or procedures may turn stimulation off or may cause
permanent damage to the Nalu Implantable Pulse Generator particularly if used in close proximity to the device:
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Lithotripsy
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Electrocautery. Do not use monopolar cautery
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External defibrillation
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Radiation therapy
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Ultrasonic scanning
•
High-output ultrasound
•
Bone growth stimulators
•
Dental Drills and Ultrasonic Probes
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Electrolysis
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Laser Procedures
•
Radiation Therapy
•
TENS (transcutaneous electrical nerve stimulation)
If the user is required by medical necessity to undergo any of the above therapies or procedures, the procedural
guidelines below must be followed. Ultimately, however, the device may need to be explanted as a result of
associated failure.
•
Turn off stimulation of the Nalu Implantable Pulse Generator before the procedure or therapy.
•
All equipment, including ground plates and paddles, must be used as far away from the Implantable Pulse
Generator as possible.
•
Bipolar electrocautery is recommended. Do not use monopolar electrocautery.
•
Every effort should be taken to keep fields, including current, radiation, or high-output ultrasonic beams,
away from the Implantable Pulse Generator.
•
If radiation therapy is required, the area over the Nalu Implantable Pulse Generator should be shielded with
Lead.
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Equipment should be set to the lowest energy setting clinically indicated.
