7
•
Non-Emergency Procedures –
Do not have non-emergency procedures while
undergoing trial stimulation.
•
Emergency Procedures –
Designate a representative (family member or close
friend) to notify any emergency medical personnel of your neurostimulator
implant, if emergency care is required. You will be provided with a Medical Alert
Card to carry with you to inform emergency medical personnel of your implant.
Be advised to use caution when undergoing any procedure that could include RF
or microwave ablation, defibrillation or cardio version.
•
Routine Medical Procedures –
Do not undergo dental procedures, diathermy,
electrolysis, diagnostic ultrasound, static field therapeutic magnets, diagnostic
X-ray, or high output ultrasonic lithotripsy. These procedures may provide
interference that can affect TNS or INS device operation or use or damage
components of the system that may cause patient harm. If you are given any
medical treatment in which an electrical current is passed through your body from
an external source, either the device should first be deactivated, or care should
be taken to monitor the functioning of the neurostimulator during the initial stages
of treatment.
•
Diathermy Therapy –
Do not use short-wave diathermy, microwave diathermy,
or therapeutic ultrasound diathermy (all now referred to as diathermy) on
patients implanted with a neurostimulation system. Energy from diathermy can
be transferred through the implanted system and cause tissue damage at the
location of the implanted electrodes, resulting in severe injury or death. Diathermy
is further prohibited because it may also damage the neurostimulation system
components. This damage could result in loss of therapy, requiring additional
surgery for system removal and replacement. Injury or damage can occur during
diathermy treatment whether the neurostimulation system is turned on or off. All
patients are advised to inform their health care professionals that they should not
be exposed to diathermy treatment.
•
Explosive or Flammable Gases –
Do not use the patient programmer to
communicate with the INS or TNS in an environment where explosive or
flammable gas fumes or vapors are present. The operation of the programmer
could cause them to ignite, causing severe burns, injury, or death.
Warnings Regarding the Trial Neurostimulator
• Exposure to Fluids
– Exposure of the external TNS or the Connector Cable
to water, body fluids, saline, or cleaning agents can cause corrosion and affect
stimulation. Do not immerse the external TNS or Connector Cable in fluids.
• Wear the TNS on the outside of your clothing or on a belt.
Warnings - For Use in Home or Work Environments
• Equipment Operation -
Patients who feel an uncomfortable change in
paresthesia during motion should avoid driving a car or operating other
potentially dangerous machinery while stimulation is on. You could be distracted
from driving or device operation if sudden changes in stimulation occur.
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