Prescribing Information

Indications For BioniCAre

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 when pain syndromes are undiagnosed until etiology is established.

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.

 WARNINGS

The BioniCare Knee System must be used only as prescribed and applied only to the knee.

  • Patients with demand style cardiac pacemakers should consult with their physician prior to use of this system.
  • The safety of the BioniCare Knee System for use during pregnancy or birth 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 Device is in use.

Indications For OACTIVE and Eagle OA

  • Mild to severe unicompartmental knee osteoarthritis.
  • Medial or lateral compartment.

 WARNINGS

If you experience pain, swelling, sensation changes, or unusual reactions while using this product, contact VQ OrthoCare’s Patient Care department at 800.452.7993 or consult a physician.

 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 the device.