Exogen Overview; Indications For Use; Exogen Description; Exogen Device (Exogen) - Bioventus EXOGEN Guia Del Usuario

EXOGEN Overview

Indications for Use

EXOGEN Description

The EXOGEN Ultrasound Bone Healing System
The EXOGEN Ultrasound Bone Healing System
provides non-invasive therapy for healing
is indicated for:
non-unions and accelerating time to healing of
• The non-invasive treatment of established
fresh fractures. EXOGEN is designed both for
non-unions † excluding skull and vertebra.
use with conservatively-treated fresh fractures
• Accelerating the time to a healed fracture for fresh,
and non-unions, or surgically-treated non-unions.
closed, posteriorly displaced distal radius fractures
EXOGEN transmits a low-intensity ultrasound
(fractures of the end of the large bone in your
signal to the fracture site through coupling gel,
forearm) and fresh, closed or Grade I open tibial
diaphysis fractures (fractures in the middle 80%
with little or no sensation felt by the patient
of the large bone in your lower leg) in skeletally
during the treatment. Low-intensity pulsed
mature individuals when these fractures are
ultrasound has been shown in in-vitro and in-
orthopaedically managed by closed reduction
vivo studies to stimulate cells to produce growth
and cast immobilization (adult individuals eighteen
years of age or older who have fractures, with or factors and proteins that are important to bone
without minor skin wounds, that are placed in a
healing.
cast for treatment).
†
A non-union is considered to be established when
the fracture site shows no visibly progressive signs
of healing.
Gel
Charger
EXOGEN Device

Strap

Figure 1: EXOGEN Ultrasound Bone Healing System
1
The patient administers treatment at home
or at work, once daily, for 20 minutes, or as
prescribed by a physician. EXOGEN auto-
matically alerts the patient in case of improper
application or performance. The EXOGEN
Ultrasound Bone Healing System consists of
one EXOGEN device, a charger, a gel bottle
and strap. The EXOGEN device provides the
treatment control circuitry, the battery supply
and monitors the operation of the transducer
at the fracture site. The signal specifications
cannot be changed.
Everything you need to treat your fracture is
included in the EXOGEN Ultrasound Bone
Healing System. (See Figure 1). If one of the
items in Figure 1 is missing, please contact
Customer Service at 1-800-836-4080 to
receive a replacement.

EXOGEN Device (EXOGEN)

Charger (power supply)

EXOGEN (Figure 2) features a transducer at the EXOGEN is powered by a rechargeable battery.
end of a coiled cord, color screen, power button A charger (Figure 3) is included with EXOGEN.
and USB charging port. The cord and transducer Only use this supplied charger with EXOGEN. Do
are not removable from EXOGEN. not plug other chargers into EXOGEN. Other
chargers may cause injury to you or others near
EXOGEN contains the internal electronics and
EXOGEN as well as damage to the charger. The
battery. It checks the ultrasound signal to make
use of chargers, transducers or cables, other than
sure EXOGEN works properly. The transducer
those supplied, may result in increased radio
sends low-intensity pulsed ultrasound to the
frequency emissions or decreased electromag-
fracture site through the gel. EXOGEN can also
netic immunity of the EXOGEN which may cause
sense if gel is present on the transducer surface.
EXOGEN to stop working.
EXOGEN stores and displays a calendar of daily
The USB plug end of the cord plugs into
use. This data is available to you and your
EXOGEN. The other end plugs into a wall
physician.
outlet. The charger requires a standard US
120 VAC, 60 Hz, household electrical outlet.
EXOGEN has a mini-USB charging port to allow
you to recharge the battery. EXOGEN will not
Read more about how to charge EXOGEN in
communicate with any other electrical devices.
"Getting Started" on page 5.
USB charging
port
Coiled cord
Figure 2 – EXOGEN Device
(Part Number: 71034401)
Figure 3 – EXOGEN Charger
Mini USB plug
Strap
The strap (Figure 4) is used to position the
transducer over your treatment site. The strap
has a port in it to hold the transducer in place.
The cap holds the transducer down on the
treatment site. The strap is adjustable to fit
most fracture locations. If your strap does not
Color Screen
fit the location of your fracture, please contact
Customer Service at 1-800-836-4080 to find out
if there is another strap which may fit better.
Button
Figure 4 – EXOGEN Strap
(Part Number: 71034622)
Transducer
(Part Number: 71034460)
Port
Cap
Strap
2