A. Introduction
Your physician has prescribed a device, the EXOGEN
4000+™ Bone Healing System, which may heal your
nonunion or accelerate the healing of your fracture. This
device utilizes pulsed, low-intensity ultrasound, which has
been shown to heal non-unions and to speed up fracture
healing. You are an active participant with the physician
during this course of therapy.
Questions regarding your fracture should be referred to
your physician.
Please call the Patient Service Department of Smith &
Nephew, Inc., regarding any problem with the EXOGEN
4000+ device that cannot be resolved after consulting this
manual. The Patient Service Department may be reached at:
In the United States, call (800) 836-4080, select option 2;
In Europe, call (+49) 746-22080; and
In Other Countries, call (USA) (+1) 901-396-2121
The EXOGEN 4000+ device is provided to you for the
treatment of your fracture upon the prescription of your
physician.
PLEASE BE SURE TO READ THE ENTIRE MANUAL
BEFORE USING THE EXOGEN 4000+ DEVICE.
B. Indications for Use
The EXOGEN 4000+, or any other EXOGEN Bone Healing
System is indicated for the non-invasive treatment of
established nonunions
†
excluding skull and vertebra. In
addition, they are indicated for accelerating the time to a
healed fracture, for fresh, closed, posteriorly displaced
distal radius (Colles’) fractures (fractures of the end of the
large bone in your forearm) and fresh, closed or Grade I
open tibial diaphysis fractures (fractures in the middle 80%
of the large bone in your lower leg) in skeletally mature
individuals when these fractures are orthopaedically
managed by closed reduction and cast immobilization
(adult individuals eighteen years of age or older who have
fractures, with or without minor skin wounds, that are
placed in a cast for treatment).
†
A nonunion is considered to be established when the
fracture site shows no visibly progressive signs of healing.
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