Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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Electric power infrastructure controlled environments (i.e. step down transformers or high voltage power
lines)
Implanted Cardiac or Other Neurostimulation Systems
—Patients who have implanted cardiac or other
neurostimulation systems should not use the Nalu Neurostimulation System. Electrical pulses from the Nalu
Neurostimulation System may interact with the sensing operation of an implanted cardiac or neurostimulation
system, causing the system to respond inappropriately.
Warnings
Electromagnetic Interference (EMI)
—EMI is a field of energy generated by equipment found in the home, work,
medical, or public environments. Very strong EMI can interfere with the System. The device includes features that
provide protection from EMI. Most electrical device and magnets encountered in a normal day will not affect the
operation of the System, however, strong sources of EMI could result in the following:
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Serious user injury resulting from heating of the implanted device and damage to surrounding tissue.
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System damage resulting in a loss of, or change in, symptom control that might require additional surgery.
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Operational changes to the Therapy Disc. This may cause the external device to turn on, turn off, or reset
to factory settings. If this occurs, the Therapy Disc needs to be reprogrammed.
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Unexpected changes in stimulation, causing a momentary increase in stimulation or intermittent stimulation.
Some users have described a jolting or shocking sensation. Although the unexpected change in stimulation
may feel uncomfortable, it will not damage the device or cause direct injury to the user. In rare cases, as a
result of the unexpected changes in stimulation, users have fallen down and been injured.
If you suspect that your Nalu Neurostimulation System is being affected by EMI, then you should:
•
For the Therapy Disc
– Remove or Turn Off
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For the Trial Therapy Disc
– Disconnect and/or Turn Off Stimulation
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Immediately move away from the equipment or object.
Electromagnetic Equipment/ Environments
—Avoidance of high electromagnetic equipment radiators or
environments is highly encouraged. Examples of equipment and/or environments include the following:
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High-power amateur transmitters/antennas or citizen band (CB) radio or Ham radio used for private
recreation, communication, and wireless experimentation.
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Electric arc welding or resistance welding equipment used for melting and joining metals or plastics.
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Industrial electric induction furnace/heater or electric arc furnace/heater used for melting metals and
plastics.
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High-voltage areas identified by fenced areas, restricted access signs, and caution signs (safe if outside
the fenced area).
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Microwave transmitters identified by fenced areas, restricted access signs, and caution signs (safe if outside
the fenced area).
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Television, cell phone and radio towers identified by fenced areas, restricted access signs, and caution
signs (safe if outside the fenced area).
•
Linear power amplifiers used for increasing the power output of radio transmitters, wireless communication
applications, audio equipment or other electronic equipment.
•
Radio telemetry equipment used for tracking location of vehicles, equipment or animals.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
