Document Reference: ENG-UMAN-000731
Revision: 5.00
Page 7 of 61
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
Saluda Medical.
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.
4.2
Precautions
Physician training
Implanting physicians should be trained in spinal cord stimulation (SCS) procedures.
Physicians should review the Evoke SCS System Surgical Guide before surgery.
Medical therapies
When used in close proximity to the Evoke System, the following medical therapies may
turn stimulation off or cause damage to the CLS:
Lithotripsy
Electrocautery
External defibrillation
Radiation therapy (any damage to the device by radiation may not be immediately
detectable).
Ultrasonic scanning
High-output ultrasound
TENS
Psychotherapeutic procedures (e.g. electroconvulsive therapy, transcranial
magnetic stimulation).
Laser procedures
If the patient is required to undergo these therapies:
1.
Turn off stimulation.
2.
Disconnect the eCLS if one is in use
3.
Ensure all fields, electrodes, probes and/or ground plates are as far away as
possible from the Evoke System.
4.
Use the lowest energy setting needed for the therapy.
