User's Manual

Device Components
The use of non-Bioness components with the StimRouter system may result in damage to the
system and increased risk to the patient.
Flammable Fuel or Chemicals
Advise patients to turn the StimRouter system (patient programmer and stimulation) off when
near a refueling point, flammable fuel, fumes or chemicals. The operation of the StimRouter could
cause the chemicals or fumes to ignite, causing severe burns, injury or death.
Driving and Operating Machinery
StimRouter stimulation should be off while driving and operating machinery.
Electromagnetic Compatibility Warnings
Medical Devices/Therapies
The following medical therapies or procedures may turn stimulation off, may cause permanent
damage to the external components and may injure the patient, particularly if used in close
proximity to the system components:
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Lithotripsy
Electrocautery
External defibrillation
Ultrasonic scanning
High-output ultrasound
Electromagnetic interference (EMI) from the following medical procedures is unlikely to
affect the StimRouter system:
Computerized Axial Tomography (CT or CAT) scans
Diagnostic ultrasound (e.g., carotid scan, Doppler studies)
Diagnostic x-rays or fluoroscopy
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Note: Advise patients to remove the StimRouter electrode before undergoing medical therapies
or procedures.
Chapter 2 - Warnings and Cautions
9