Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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Instruct users to confirm Implantable Pulse Generator functionality following treatment by turning on the
Implantable Pulse Generator and gradually increasing stimulation to the desired level.
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Damage from these procedures to the Nalu Neurostimulation System may not be detected immediately.
Psychotherapeutic Procedures
—Safety has not been established for psychotherapeutic procedures using
equipment that generates electromagnetic interference (e.g., electroconvulsive therapy, transcranial magnetic
stimulation) in users who have spinal cord stimulators. Induced electrical currents can cause heating that may result
in tissue damage.
Other Medical Procedures—
EMI from the following medical procedures is unlikely to affect the device:
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Diagnostic x-rays or fluoroscopy
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Magnetoencephalography (MEG)
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Positron emission tomography (PET) scans
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Therapeutic magnets (e.g., magnetic mattresses, blankets, wrist wraps, elbow wraps)
Painful Stimulation—
If the user experiences painful stimulation do the following:
For Therapy Disc
– Remove or decrease the stimulation amplitude
For Trial Therapy Disc
– Disconnect or decrease the stimulation amplitude
Contact your clinician if this continues to occur.
Strangulation—
Entanglement in the Therapy Disc Charger cable, Electrode Interfacing Cable, or Relief Belt may
cause a fall or strangulation.
Tampering
- Do not modify or tamper with any component of the Nalu Neurostimulation System. Tampering with
the device could result in harm. If the device is not working properly, contact your clinician for help.
Precautions
Clinician Training –
If you have a Nalu Neurostimulation System, please inform your regular clinician or specialist.
Your clinician should visit www.nalumed.com for more information about the system prior to any medical
procedures.
Clinician Instructions
– Always follow the programs and therapy instructions established by your clinician. Failure
to do so may cause the therapy to be less effective in providing pain relief.
Post-Operative—
During the two weeks following surgery, it is important to use extreme care so that appropriate
healing will secure the implanted components and close the surgical incisions:
a. Do not lift objects of more than five pounds.
b. Do not engage in rigorous physical activity such as twisting, bending, or climbing.
c. If new Leads were implanted, do not raise your arms above your head.
Temporarily, there may be some pain in the area of the implant as the incisions heal. If discomfort continues beyond
two weeks, contact your clinician.
If you notice excessive redness around the wound areas during this time, contact your clinician to check for infection
and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this
period.
Be sure to consult your clinician before making lifestyle changes due to decreases in pain.
