![]() ![]() 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. ![]() Radio telemetry equipment used for tracking location of vehicles, equipment or animals.Linear power amplifiers used for increasing the power output of radio transmitters, wireless communication applications, audio equipment or other electronic equipment.Television, cell phone and radio towers identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area).Microwave transmitters identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area).High-voltage areas identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area).Industrial electric induction furnace/heater or electric arc furnace/heater used for melting metals and plastics.Electric arc welding or resistance welding equipment used for melting and joining metals or plastics.High-power amateur transmitters/antennas or citizen band (CB) radio or Ham radio used for private recreation, communication, and wireless experimentation.Examples of equipment and/or environments include the following: Immediately move away from the equipment or object.Įlectromagnetic Equipment/ Environments-Avoidance of high electromagnetic equipment radiators or environments is highly encouraged.For the Trial Therapy Disc – Disconnect and/or Turn Off Stimulation.For the Therapy Disc – Remove or Turn Off.If you suspect that your Nalu Neurostimulation System is being affected by EMI, then you should: In rare cases, as a result of the unexpected changes in stimulation, users have fallen down and been injured. Although the unexpected change in stimulation may feel uncomfortable, it will not damage the device or cause direct injury to the user. Some users have described a jolting or shocking sensation. Unexpected changes in stimulation, causing a momentary increase in stimulation or intermittent stimulation.If this occurs, the Therapy Disc needs to be reprogrammed. This may cause the external device to turn on, turn off, or reset to factory settings. Operational changes to the Therapy Disc.System damage resulting in a loss of, or change in, symptom control that might require additional surgery.Serious user injury resulting from heating of the implanted device and damage to surrounding tissue.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: The device includes features that provide protection from EMI. Very strong EMI can interfere with the System. WarningsĮlectromagnetic Interference (EMI)-EMI is a field of energy generated by equipment found in the home, work, medical, or public environments. 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. Implanted Cardiac or Other Neurostimulation Systems-Patients who have implanted cardiac or other neurostimulation systems should not use the Nalu Neurostimulation System. step down transformers or high voltage power lines) Electric power infrastructure controlled environments (i.e.Facilities using radiofrequency heat sealers or induction heaters.Radio or cell phone transmission stations.Examples of environments having high level non-ionizing radiation include the following: The energy in high-level areas can be transferred through the device and cause tissue damage, resulting in severe injury. Occupational exposure to high levels of non-ionizing radiation that may interfere with therapy – Patients who regularly work in environments with elevated levels of non-ionizing radiation should not be implanted with the device. The energy from diathermy can be transferred through the stimulator and cause tissue damage, resulting in severe injury. Have failed trial stimulation by failing to receive effective pain reliefĮxposure to shortwave, microwave, or ultrasound diathermy – Diathermy should not be operated within the vicinity of a patient implanted with a Nalu Neurostimulation System or when wearing a Therapy Disc.Users contraindicated for this therapy are those who: ![]()
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