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BioniCare
®
Knee System
Prescribing Information
Caution
Federal law restricts this device to sale by, or on the order of, a practitioner
licensed by the law of the State in which he/she practices to use or order the
use of this device.
Indication
The BioniCare Knee System is indicated “for use as an adjunctive therapy in
reducing the level of pain and symptoms associated with osteoarthritis of the
knee and for overall improvement of the knee as assessed by the physician’s
global evaluation (clinical studies).”
Contraindications
• Do not use the BioniCare Knee System for any electrode placement that
applies current to the carotid sinus (neck) region.
• Do not use the BioniCare Knee System for any electrode placement that
causes current to flow transcerebrally (through the head).
• Do not use the BioniCare Knee System whenever pain syndromes are
undiagnosed, until etiology is established.
Warnings
• The BioniCare Knee System must be used only as prescribed and applied
only to the knee.
• Patients with demand type cardiac pacemakers should consult with their
physician prior to use of this system.
• The safety of the BioniCare Knee System for use during pregnancy has
not been established.
• The BioniCare Knee System is not effective for pain of central origin
(including headache).
• Use only under the continued supervision of a physician.
• Keep out of reach of children.
• Electronic monitoring equipment (such as ECG monitors and ECG alarms)
may not operate properly when the BioniCare Knee System is in use.
Precautions
• Isolated cases of skin irritation may occur at the site of electrode
placement following long-term application.
Adverse Reactions
• Skin irritation and electrode burns are potential adverse reactions.
Patients with skin irritation / reactions should be monitored.
