User's Manual

Cell Phones
There is potential for interference between electronic devices, including cell phones. Stimulation
control may be delayed. If interference is suspected or anticipated, distance yourself from the
source of interference. To minimize interference, maintain a minimum safe separation distance
of 15 cm (6 in.) between the StimRouter system and all other electronic devices.
Precautions
Clinician Training
Bioness requires that clinicians involved with the use of the StimRouter system be formally trained
by Bioness in the system’s operation and use.
Post-Operative Care
Clinicians should adequately observe the incision site and monitor for infection, possible device
rejection or other possible adverse effects. If the patient notices excessive redness or discharge
around the incision site, then the implant physician should be contacted immediately to check for
infection and administer proper treatment following standard medical procedures.
Implant Location
Advise patients to never manipulate the StimRouter lead. If the lead is moved from the target
stimulation point, then it may not function correctly or effectively. In some instances a lead can
move from its original location, thus causing a loss of stimulation at the target stimulation point.
If the lead moves, then the lead may need to be replaced.
For Single Patient Use Only
The StimRouter electrode is meant to be worn only by the patient for whom it is prescribed and
in the location for which it is prescribed. The StimRouter electrode should not be adhered to any
other person or any other place on the patient’s body.
Postural Changes
Changes in posture or abrupt movements may decrease or increase the perceived level of
stimulation. Advise patients to turn off stimulation before making extreme posture changes or
abrupt movements such as stretching, lifting of arms overhead or exercising.
Chapter 2 - Warnings and Cautions
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