User's Manual

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Warnings and Cautions
Clinicians and patients should know the limitations, warnings and precautions associated with
the StimRouter Neuromodulation System. Clinicians should review the warnings and precautions
and instructions for use with the patient. If at any time the clinician or patient is concerned about
the safety or effectiveness of the StimRouter system, then call your local distributor.
The StimRouter programming system and patient-operated system should only be used under
proper medical guidance and as described in this StimRouter Clinician’s Guide and in the StimRouter
User’s Guide.
Indications for Use
The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation
via an implanted lead to a target peripheral nerve, for aid in the management of adults that have
severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy
(e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region.
Contraindications
The Bioness StimRouter Neuromodulation System is contraindicated for:
•
Patients who have any active implanted device such as an implanted demand cardiac
pacemaker or defibrillator, or any metallic implant in the immediate area intended
for implant. Maintain a minimum safe separation distance of 15 cm (6 in.) between the
SimRouter system and all other active implanted devices and metallic implants.
A risk/benefit determination should be performed before using the StimRouter system for:
•
Patients exposed to diathermy. Shortwave, microwave and/or therapeutic ultrasound
diathermy should not be used on patients who have a StimRouter Neuromodulation
System. The energy generated by diathermy can be transferred through the StimRouter
system components, causing tissue damage at the lead site and potentially resulting in
severe injury. Diathermy may also damage the StimRouter system components,
resulting in loss of therapy. Injury or damage can occur during diathermy treatment
Chapter 2 - Warnings and Cautions
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