Precautions - SALUDA MEDICAL Evoke SCS User Manual

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.

4.2 Precautions

You must inform your clinician that you have an implanted stimulator before
undertaking other treatments. Ask your clinician to refer to the Evoke SCS System Surgical
Guide for information on precautions to follow for the following treatments:
• Lithotripsy, which uses sound waves to disintegrate gallstones and kidney stones.
• Electrocautery or electrosurgery, which uses an electric current to cut tissue and stop
bleeding during surgery.
• External defibrillation, which uses a strong electric shock to the chest wall to restore
rhythm to the heart.
• Radiation therapy or radiotherapy, which uses ionising radiation, usually to control or
kill malignant cancer cells.
• Ultrasound and Doppler ultrasound, which use very high frequency sound waves to
create images of your internal organs or to monitor the state of a pregnancy.
• High intensity ultrasound, which uses very high frequency sound waves to create heat
inside bones or muscle.
• Transcutaneous electrical nerve stimulation (TENS), which uses electric current to
stimulate nerves for therapeutic purposes.
• Psychotherapeutic procedures such as Transcranial Magnetic Stimulation or
Electroconvulsive Therapy.
• Laser procedures.
Operating equipment
The Evoke System is a SCS system that measures the patient's Evoked Compound Action
Potential (ECAP) in response to stimulation and adjusts the amplitude of stimulation in order to
maintain stable coverage of painful areas. This is known as ECAP-controlled closed-loop
stimulation.
When the stimulator is operating with closed-loop stimulation enabled:
• You may leave stimulation on while operating automobiles, other vehicles, or potentially
dangerous equipment.
• If you are charging the stimulator, closed-loop is disabled, so you should turn
stimulation off if charging while driving or operating equipment.
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Evoke® SCS System User Manual
Revision: 4.01 Page 8 of 53