User's Manual

whether neurostimulation is turned on or off. All patients are advised to inform their
health-care professionals that they should not be exposed to diathermy.
Patients exposed to therapeutic ultrasound.
Patients who are unable to operate the StimRouter system.
Patient who are high surgical risks or poor surgical candidates in general.
Patients who have a cancerous lesion present near the target stimulation point or near
to where the StimRouter electrode will adhere.
Patients who are known or suspected to have a nickel allergy. The handles of the
tunneling needle and tunneling needle stylet are nickel plated.
Patients with bleeding disorders or active anticoagulation that cannot be stopped for a
few days close to the time of the surgical procedure.
•
•
•
•
•
•
Implantation Setting
The StimRouter should be implanted in an appropriately outfitted physician office, outpatient
surgical center or hospital surgical center. Fluoroscopy and/or ultrasound should be available if
deemed necessary and be used at the implanting physician’s discretion.
Patient Screening
Candidates for StimRouter therapy should be appropriately screened for selection and fully
informed about the therapy risks and benefits, the surgical procedure, system operation and
self-treatment responsibilities.
Select patients carefully to ensure that:
•
•
•
Their symptoms are of an anatomical and/or physiological origin.
They are appropriate candidates for surgery.
They can properly operate the StimRouter system.
Bioness highly recommends the following screening procedure prior to StimRouter lead
implantation:
•
•
Nerve block using local anesthesia.
Psychological screening using techniques traditionally used for similar types of
procedures and systems.
4
Clinician’s Guide