EBI BONE HEALING SYSTEM�

INDICATIONS AND USAGE:
The EBI Bone Healing System� is indicated for the treatment of fracture nonunions, failed fusions and congenital pseudarthroses in the appendicular system. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. The original 1979 PMA study included 146 patients with nonunion fractures. These difficult fractures were characterized as follows: 2.3 average number of prior surgeries and an average of 37 months (median 20 months) since original injury. These patients were followed for a minimum of 4 years (average 7 years) from the date of treatment termination, with a success rate of 63.5%. Even though long term follow-up requirements were not included in the original study design, a follow-up rate of 82% was achieved. Forty-three (43) of the original 48 patients in the congenital pseudarthrosis study were classified by Bassett1 who defined the tibial lesions as Type I (n=6), Type II (n=19), and Type III (n=18), with Type III being the most severe and recalcitrant to treatment. The success rate for Bassett Type I lesions was 66.7%, Bassett Type II lesions 57.9% and Bassett Type III lesions 22.2%. The long term post treatment follow-up for the congenital pseudarthrosis study patient population (n=48) was to skeletal maturity or the age of 18. The study had an 87.5% follow-up rate. 1Bassett CAL, Caulo N, Kort J. Congenital "pseudarthrosis" of the tibia: treatment with pulsing electromagnetic fields. Clinical Orthop. 1981:154:136-149.

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 the system on pregnant patients has not been evaluated and, therefore, is not recommended in these cases.

WARNINGS:
The long term effects of exposure to low level magnetic fields are not known. Routine use of the EBI Bone Healing System� for over 20 years has indicated no known risks. During the treatment of patients with open epiphyses, when the epiphysis is in the pulsing field, physicians are advised that the epiphyseal growth plates should be monitored for possible effects. Use of the EBI Bone Healing System� for spine and skull has not been evaluated. To reduce the risk of potential injury: 1) Avoid touching the battery charger contacts when the battery charger is plugged into an outlet, 2) Do not place the battery charger in bed with you if you are using the unit while you are sleeping. The control unit and battery charger are electrically live when connected together and the battery charger is plugged into an outlet. To reduce the risk of serious injury by electric shock: 1) Do not permit the battery charger to be connected when wet. 2) Do not immerse the control unit, the coil or the battery charger in water.

PRECAUTIONS:
The following conditions may compromise a successful treatment outcome: Nonunion fractures with gaps in excess of 1cm. Presence of fixation devices made from magnetic materials. (Most presently used internal or external fixation devices are constructed of 316L S.S., titanium alloys or cobalt-chromium alloys that are non-magnetic and, therefore, compatible with the EBI Bone Healing System�.)

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Dexter
a.k.a. Titus Andronicus