User's Manual
Information for Prescribers
Precision Spectra™ System Information for Prescribers
90668515-01 Rev A 8 of 15
Precautions
Physician training is required.
Medical Devices/Therapies. The following medical therapies or procedures may turn
stimulation off or may cause permanent damage to the Stimulator, particularly if used in close
proximity to the device:
• lithotripsy
• electrocautery (See “Instructions for the Physician” on page 11)
• external defi brillation
• radiation therapy (Any damage to the device by radiation may not be immediately
detectable.)
• ultrasonic scanning
• high-output ultrasound
If any of the above is required by medical necessity, refer to “Instructions for the Physician” on
page 11. Ultimately, however, the device may require explantation as a result of damage to
the device.
Automobiles and Other Equipment. Patients should not operate automobiles, other
motorized vehicles, or potentially dangerous machinery/ equipment with therapeutic stimulation
switched on. Stimulation must be turned off fi rst. Sudden stimulation changes, if they occur,
may distract patients from attentive operation of the vehicle or equipment.
Post Operative. During the two weeks following surgery, it is important that patients use
extreme care so that appropriate healing will secure the implanted components and close the
surgical incisions:
• Patients should not lift objects of more than fi ve pounds.
• Patients should not engage in rigorous physical activity such as twisting, bending, or
climbing.
• If new leads were implanted, patients should not raise their arms above their head.
Temporarily, there may be some pain in the area of the implant as the incisions heal. Patients
should be instructed that if discomfort continues beyond two weeks, they should contact their
physician.
If patients notice excessive redness around the wound areas during this time, they should
contact their physician to check for infection and administer proper treatment. In rare cases,
adverse tissue reaction to implanted materials can occur during this period.
Patients should consult their physician before making lifestyle changes due to decreases in
pain.