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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 and radio towers identified by fenced areas, restricted
access signs, and caution signs (safe if outside the fenced area).
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Linear power amplifiers used for increasing the power output of radio
transmitters, wireless communication applications, audio equipment
or other electronic equipment.
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Radio telemetry equipment used for tracking location of vehicles,
equipment or animals.
Active Implantable or Body Worn Medical Devices
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Safety has not been
established for patients who use the Freedom SCS System with other active
implantable or body worn medical devices. These devices include other
neurostimulation systems, insulin pumps, automated external defibrillators
(AED), cochlear implants, and wearable medical sensors. Malfunction and/or
damage could occur to either system that could result in harm to the patient or
other people nearby.
Magnetic Resonance Imaging (MRI)
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The Freedom-8A/4A SCS System is MR
Unsafe.
Since the Freedom-8A/4A SCS System is MR Unsafe, the strong
magnetic field of the MR system could attract or otherwise damage the
System, and in the process cause serious harm to the patient or other people
or damage to the MR system.
The WAA component is MR Unsafe; ensure that the WAA does not enter the
MR system room.
Since the WAA is MR Unsafe, the strong magnetic field of the
MR system could attract or otherwise damage the WAA, and in the process
cause serious harm to the patient or other people or damage the MR system.
Radiofrequency (RF) ablation
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Safety has not been established for
radiofrequency (RF) ablation in patients with a Stimulator. RF ablation may
cause induced electrical currents that result in heating and tissue damage. Do
not use RF ablation anywhere near the Stimulator. If RF ablation is used, ensure
that ablation is not performed over or near the Stimulator.
