Biomet® EBI Bone Healing System

By prescribing the Biomet® EBI Bone Healing System, your doctor has taken advantage of an adjunctive non invasive treatment to aid in the healing of your facture nonunion. The Biomet® EBI Bone Healing System promotes normal healing by inducing weak pulsing electrical signals at the nonunion fracture site. These signals are generated by a low energy electromagnetic field created by passing specific electrical current pulses through a flexible therapeutic treatment coil. A specific electrical current is delivered to the coil by the control unit. The coil then delivers the therapeutic electromagnetic signal to the nonunion fracture site.

Easy To Use and Operate

You can treat with the Biomet® EBI Bone Healing System using one of the anatomically configured SFLX Flexible Treatment Coils. The SFLX flexible treatment coil may be incorporated into a cast, over a cast or brace, or applied directly to the skin when a cast is not utilized. You must follow the treatment schedule prescribed by your doctor which is normally ten (10) hours per day. It is very important that you treat with the Biomet® EBI Bone Healing System for the recommended ten hours per day. If you are unable to treat for ten continuous hours, it is recommended that you break up the total treatment time into multiple treatment sessions. The Biomet® EBI Bone Healing System can only be obtained with a doctor's prescription. Upon receiving your Biomet® EBI Bone Healing System you will receive a Patient Manual containing complete instructions. Your compliance with these instructions is important to the successful outcome of your treatment.

System Advantages

EBI Bone Healing System® - Model 2001

INDICATIONS:

The Biomet® EBI Bone Healing System - P790002/S028 is indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudarthrosis in the appendicular system.

USAGE:

These device systems are durable therapeutic electrical devices intended for single patient use only under a prescription. Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. Rx Only - Prescription Only - Single Patient Use Only - Not for Re-Sale or Re-Distribution - Do Not Reuse.

CONTRAINDICATIONS:

Nonunion fractures in which a synovial pseudarthrosis (fluid filled gap) exists. Under certain conditions, electromagnetic stimulation could inhibit the output of some demand pacemakers or implantable defibrillators. Therefore, it is not recommended for patients with certain types of pacemakers or implantable defibrillators. Patients should be cautioned to avoid coming in close proximity to pacemaker or defibrillator wearers during stimulation. Use of these device systems on pregnant patients has not been evaluated; therefore, it is not recommended in these cases.

For complete prescribing information including success rates, warnings, and precautions, please visit www.biomet.com/stimmanuals or call 1.800.526.2579.

*Biomet has prescribed more than 1 million non-invasive stimulation devices