Prescribing Information - VQ OrthoCare BioniCare Manual De Instructiones

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, Model BIO-2000, 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.
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