Prescribing Information - VQ OrthoCare BioniCare Hand System Manual De Instrucciones

Prescribing Information

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
or any other practitioner licensed by the law of the State in which he practices.
Indication
The BioniCare Hand System is indicated "for use as an adjunctive therapy in reducing
the level of pain and stiffness associated with pain from rheumatoid arthritis of the
hand."
Contraindications
• Do not use the BioniCare Hand System for any electrode placement that
applies current to the carotid sinus (neck) region.
• Do not use the BioniCare Hand System for any electrode placement that
causes current to flow transcerebrally (through the head).
• Patients with demand type cardiac pacemakers should consult with their
physician prior to use of this system.
• Do not use the BioniCare Hand System whenever pain syndromes are
undiagnosed, until etiology is established.
Warnings
• The BioniCare Hand System must be used only as prescribed and applied
only to the hand.
• The safety of the BioniCare Hand System for use during pregnancy has
not been established.
• The BioniCare Hand 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 Hand Device is in use.
Precautions
• Isolated cases of skin irritation may occur at the site of conductors and
conductive glove placement following long-term application.
• Effectiveness is highly dependent upon patient selection by a physician
qualified in the management of arthritis.
BioniCare Hand System
®
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