User Manual

Safety Instructions

Warnings

Pregnancy. The safety and/or effectiveness of neurostimulation dur-

ing pregnancy has not been established.

Diathermy. Shortwave, microwave and/or therapeutic ultrasound

diathermy are categorically contraindicated for SCS patients. The

energy generated by diathermy can be transferred through the stimu-

lator system, causing tissue damage at the lead site and resulting in

severe injury or death.

Implanted Stimulation Devices. Spinal cord stimulators may

interfere with the operation of implanted sensing stimulators such as

pacemakers or cardioverter defibrillators. The effects of implanted

stimulation devices on neurostimulators is unknown.

Implant Damage. Burns may result if the pulse generator case is

ruptured or pierced and patient tissue is exposed to battery chemicals.

Do not implant the device if the case is damaged.

Postural Changes. Patients should be advised that changes in pos-

ture or abrupt movements may cause decreases, or uncomfortable or

painful increases in the perceived stimulation level.

Electromagnetic Interference. Strong electromagnetic fields can

potentially turn the stimulator off, or cause uncomfortable or jolting

stimulation. Patients should be counseled to avoid or exercise care

around:

• Theft detectors or security screeners

• Power lines or power generators

• Electric steel furnaces and arc welders

• Large, magnetized stereo speakers