Boston Scientific Precision - Precautions

Precision™ Spinal Cord Stimulator System Clinician Manual
Clinician Manual
97035873-01 10 of 75
• Other sources of electromagnetic disturbance, such as RF transmitters at television or radio
broadcast stations, Amateur Radio or Citizens Band radio transceivers, or Family Radio Service band
transceivers.
Note: When in close proximity, equipment that generates strong electromagnetic elds might cause
unintended stimulation or interfere with wireless communication even if they comply with International
Special Committee on Radio Interference (CISPR) requirements.
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: Do not use monopolar cautery. See “Instructions for the Physician” on page 12
• external debrillation
• radiation therapy
• ultrasonic scanning
• high-output ultrasound
If any of the above is required by medical necessity, refer to “Instructions for the Physician” on page 12 .
Ultimately, however, the device may require explantation as a result of damage to the device.
Subperception Therapy. Subperception stimulation has been demonstrated to be safe and effective in
patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least
six months. Full stimulation parameter ranges and options for both paresthesia-based and subperception
therapy are available for clinician’s use throughout the patient’s experience and treatment with SCS.
Automobiles and Other Equipment. Patients using therapy that generates paresthesia should not operate
motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the
stimulation on. Stimulation must be turned off rst in such cases. For these patients, any sudden stimulation
changes may distract patients from proper operation of the vehicle, machinery, or equipment. For therapy that
does not generate paresthesia (i.e., subperception therapy) it is less likely that sudden stimulation changes
resulting in distraction could occur while having stimulation on when operating moving vehicle, machinery,
and equipment.
Post Operative. During the two weeks following surgery, it is important to use extreme care so that
appropriate healing will secure the implanted components and close the surgical incisions:
• Do not lift objects of more than 2.5 kilograms (ve pounds).
• Do not engage in rigorous physical activity such as twisting, bending, or climbing.
• If new leads were implanted, do not raise your arms above your head.
Temporarily, there may be some pain in the area of the implant as the incisions heal. If discomfort continues
beyond two weeks, contact your physician.
If you notice excessive redness around the wound areas during this time, contact your physician to check for
infection and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can
occur during this period.
Be sure to consult your physician before making lifestyle changes due to decreases in pain.