Document Reference: ENG-UMAN-000730
Revision: 6.00
Page 7 of 40
Electromagnetic interference
•
Strong electromagnetic fields may turn the stimulator off, cause uncomfortable or
jolting stimulation or affect communication with the EPC.
•
Patients should be advised to avoid or turn stimulation off around:
o
Security screeners such as those used at of department stores, public
buildings, and airports – patients should present their implantable device ID
card and request to go around the screener; but if they are required to go
through the screener they should turn stimulation off.
o
Power lines or power generators.
o
Electric steel furnaces and arc welders.
o
Large, magnetized stereo speakers.
o
Tag deactivators such as those found in retail stores and libraries.
Heat due to charging
•
During charging, the Charger and/or CLS may become warm.
•
Patients should not charge while sleeping or with the charging coil in contact with
their skin for prolonged periods as this may result in heating that can cause redness,
skin irritation or a burn.
•
If patients experience pain or discomfort, they should cease charging and contact
their clinician.
Notification of an implanted stimulator prior to any other surgical procedures
•
Some surgical procedures that use electrical current could affect the patient’s
implanted stimulator and leads, cause serious injury, and may damage the stimulator
•
Patients should be advised to inform their clinician prior to any procedure that they
have an implanted stimulator so the procedure can be conducted without using
electric current near the implanted stimulator or leads.
Uncomfortable changes to the stimulation strength due to movement
•
Any changes in posture may cause an uncomfortable change or a painful increase in
the stimulation strength patients feel.
•
Patients should turn down the stimulation strength or turn off the stimulation before
making posture changes.
The Evoke™ System has not been tested for use in patients who are pregnant or
nursing.
The Evoke™ System has not been tested for use in patients under 18 years old.
