SALUDA MEDICAL Evoke SCS User Manual page 7

• If you feel an effect in your stimulation from an electromagnetic field, turn off your
stimulator and move out of the space as quickly as you can.
• Discuss with your doctor before entering any area that may affect how your stimulator
works, including areas displaying a warning notice preventing entry by patients fitted
with a pacemaker.
You should not charge the stimulator while sleeping, or with the Charger or Charger coil
against your skin.
• The Charger, Charger coil and/or CLS may become hot during charging.
• If you lie on or lean against the Charger or Charger coil, it may heat up enough to cause
skin redness, skin irritation or a burn.
• Ensure there are no metal objects between the Charger coil and the stimulator during
charging, as the metal object may heat up and cause skin redness, skin irritation or a
burn. Additionally, the Charger may not operate correctly.
• The Charger unit may become hot during use, with a surface temperature reaching 48 °C
(118 °F). Do not hold the Charger unit for longer than 10 minutes during use to prevent
risk of skin irritation, redness or injury.
• If you experience pain or discomfort during charging, you should stop and contact your
clinician.
Before any other surgical procedures, notify your clinician or dentist that you have an
implanted stimulator
• Some surgical procedures use electrical current that could affect your implanted
stimulator and leads, cause serious injury to you, and/or may damage your stimulator.
• Before any procedure, tell your clinician that you have an implanted stimulator, so they
can conduct the procedure without using electric current near your implanted
stimulator or leads.
If you may be allergic to parts of the stimulation system you should not be
implanted with a stimulator
• If you are allergic to some metals or plastics, please notify your clinician so that they can
check whether the items you are allergic to are used in the stimulation system.
Cables and small parts
• The cables in this system pose a strangulation risk. To avoid strangulation, be careful
when using cables and keep out of the reach of children.
• Small parts and accessories could be hazardous if swallowed or cause choking if ingested
or inhaled. Keep small parts and accessories out of the reach of children.
CLIN-UMAN-005176
Evoke® SCS System User Manual
Revision: 4.01 Page 7 of 53