Document Reference: ENG-UMAN-000730
Revision: 6.00
Page 8 of 40
Precautions
Physician training
•
Implanting physicians should be trained in SCS procedures.
•
Physicians should review this surgical manual before surgery.
Medical imaging
•
MEG, PET, x-ray/fluoroscopy and diagnostic ultrasound are unlikely to affect the
Evoke™ System
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:
o
Lithotripsy
o
Electrocautery
o
External defibrillation
o
Radiation therapy (any damage to the device by radiation may not be
immediately detectable).
o
Ultrasonic scanning
o
High-output ultrasound
o
TENS
o
Psychotherapeutic procedures (e.g. electroconvulsive therapy, transcranial
magnetic stimulation).
o
Laser procedures
If the patient is required to undergo any of 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.
5.
Check the functioning of the Evoke™ System after the procedure and contact
Saluda Medical if any problems are apparent.
6.
Use bipolar mode for electrical therapies if available
Operating equipment
•
Patients may be distracted from operation of equipment if there are sudden
stimulation changes.
•
Patients should turn stimulation off before operating automobiles, other vehicles, or
potentially dangerous equipment.
