Warnings - nalu 12001-040 User Instructions For Use

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:
•
Serious user injury resulting from heating of the implanted device and damage to surrounding tissue.
•
System damage resulting in a loss of, or change in, symptom control that might require additional
surgery.
•
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.
•
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
•
For the Trial Therapy Disc – Disconnect and/or Turn Off Stimulation
•
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:
•
High-power amateur transmitters/antennas or citizen band (CB) radio or Ham radio used for private
recreation, communication, and wireless experimentation.
Nalu User's Kit Instructions for Use PN: MA-000007 Rev J
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