Ultrasound Coupling Gel; Treatment Card; Exogen Usage; Important Things To Know - Bioventus EXOGEN User Manual

Charger (power supply) Strap
EXOGEN is powered by a rechargeable The strap (Figure 4) is used to position the
battery. A charger (Figure 3) is included transducer over your treatment site. The
with EXOGEN. Your charger may look strap has a port in it to hold the transducer
different from the image below, depending in place. The cap holds the transducer
on the country where you live. Only use this down on the treatment site. The strap is
supplied charger with EXOGEN. Do not adjustable to fit most fracture locations. If
plug other chargers into EXOGEN. Other your strap does not fit the location of your
chargers may cause injury to you or others fracture, please contact Customer Service
near EXOGEN as well as damage to the to find out if there is another strap which
charger. The use of chargers, transducers may fit better.
or cables, other than those supplied, may
result in increased radiofrequency
emissions or decreased electromagnetic
immunity of the EXOGEN which may cause
EXOGEN to stop working.
The USB plug end of the cord plugs into
EXOGEN. The other end plugs into a wall
outlet. The charger requires a standard
100-240 VAC, 50/60 Hz, household
electrical outlet. One of the following
chargers will be included with EXOGEN
depending on the electrical requirements
Figure 4 – EXOGEN Strap
of your country:
(Part Number: 71034622)
Australia: Part #71034463
Europe: Part # 71034462
United Kingdom: Part #71034461
Read more about how to charge EXOGEN
in "Getting Started" on page 4.
Mini USB plug
Figure 3 – EXOGEN Charger
2

Ultrasound Coupling Gel

Treatment Card

Ultrasound coupling gel (Figure 5) is EXOGEN comes with a Treatment Card
provided for use with EXOGEN. The (Figure 6). Based on your physician's
gel is to be placed on the transducer prescription, the amount of treatments on
every time you use EXOGEN. The gel your card may vary. Once the card is
lets the ultrasound signal reach your inserted, EXOGEN will show you how
fracture through your skin. EXOGEN many treatments you have used on your
will not work properly if gel is not covering card. EXOGEN will only work properly
the transducer and you will receive an alert if the card is inserted. The card must
from EXOGEN. remain inside of EXOGEN until all
treatments are used.
Only use the supplied gel. Do not use other
gels as they may damage the transducer Only use the Treatment Card supplied by
surface or block the signal. If you need Bioventus. Do not insert other cards in
Port
Cap
more gel, please call Customer Service. EXOGEN. Other cards may become
damaged when inserted into EXOGEN.
Note: Some patients have experienced mild
If you have not received a Treatment Card
skin irritation caused by skin sensitivity to
with your EXOGEN, contact Customer
the gel. If you feel your skin is sensitive to
Service.
the gel, you may change the gel to mineral
oil or glycerin. A selection of Treatment Cards are
available depending on your country
Strap
Cap
of residence:
Nozzle
Bottle Figure 6 – Treatment Card

EXOGEN Usage

EXOGEN should be used for 20 minutes
per day or as prescribed by your doctor. It
is important that you use EXOGEN as
prescribed by your doctor to get the full
benefit of the treatment. Your doctor will
decide when your fracture is healed. Every
Figure 5 – Ultrasound Coupling Gel
fracture is different and it takes some
(Part Number: Part #71034694)
fractures longer to heal than others.
Call your doctor if you have questions
or concerns about your fracture.
EXOGEN is for single patient use only.
EXOGEN will deliver the number of
treatments provided on your treatment
card. If this number is reached and you
are still treating your fracture under your
doctor's direction, contact Customer
Service for instructions.
Important Things
to Know
EXOGEN is approved for use by persons
that are 18 years or older and skeletally
mature. There is no maximum age limit to
using EXOGEN. The anticipated education
level of an EXOGEN user is to read English
to an 8th Grade level or equivalent, and the
ability to read and understand Western
Arabic numerals. No special previous
experience or skills are needed or expected
to be able to operate EXOGEN. There may
be physical impairments that result from the
presence of a fracture, such as reduced
range of motion or immobility. EXOGEN
is expected to be useable with one hand
used for guiding and holding EXOGEN.
Read "Getting Started" (page 4) and
"Treating Your Fracture" (page 9)
.
before you begin using EXOGEN

Contraindications

Metal Contacts
There are no known contraindications to the
Treatment Card use of EXOGEN.

Warnings

The safety and effectiveness of the use of
EXOGEN has not been established for:
• Fractures with post-reduction
displacement of more than 50% (i.e.,
fractures in which the opposing broken
bone ends are out of alignment by more
than one half of the width of the bone).
• Pathological fractures due to bone
pathology or malignancy (fractures due
to disease)
• Pregnant or nursing women
• Individuals with thrombophlebitis (blood
clot in a vein), vascular insufficiency
(poor blood supply), abnormal skin
sensitivity (very sensitive skin), sensory
paralysis (lack of sensation), alcoholism
and/or nutritional deficiency.
• Individuals receiving steroid, anti-
coagulant, prescription non-steroidal
anti-inflammatory, calcium channel
blocker and/or diphosphonate therapy.
Individuals using these therapies were
excluded from the studies because of
the possible effects of these therapies
on bone metabolism.
• Non-unions of the vertebra and the skull
• Individuals lacking skeletal maturity

Precautions

Display Symbols and
Descriptions
• EXOGEN will not correct or alter
post-reduction (when your fracture
is initially set and placed in a cast)
Symbol Name
aspects of a fracture such as displace-
ment, angulation or malalignment.
• The transducer, strap and gel are
not sterile and placement on an Charging Symbol
open wound is not advised.
• The operation of active, implantable
devices, such as cardiac pacemakers
may be adversely affected by close
Battery Status
exposure to EXOGEN. The physician
should advise the patient or other person
in close proximity during treatment to be
evaluated by the attending cardiologist
or physician before starting treatment X- Mark
with EXOGEN.
• The cords pose a risk for strangulation.
Keep out of reach of children.
• Cell phones, televisions, and other Checkmark
devices using radiofrequency energy
may cause interference. This
interference may cause EXOGEN to
operate improperly or stop operating
Double Checkmark*
completely. While EXOGEN complies
with the limits for Class B digital devices
pursuant to Part 15 of the FCC rules, it
has not been studied with all brands and
models of phone.
Double Checkmark
Plus*
• The safety and effectiveness of
EXOGEN when used for more than one
daily 20-minute treatment period has not
been studied.
Partial Treatment
• For single patient use ONLY. The risk
includes but is not limited to cross
contamination between patients as
cleaning agents and solvents are not
recommended for this system.
Treatment Symbol
• When choosing a treatment site ensure
that the site selected allows for full
contact of the transducer face with the
skin. Failure to do so may result in the
Countdown Timer
transducer being only partially coupled
to the skin. This may reduce the
effectiveness of EXOGEN in treating the
fracture.
Treatment Complete
*EXOGEN should be used for only 20 minutes per day, or as prescribed by your doctor.
Customer Service: Australia: 1800 428 220
Description
Flashes to show EXOGEN is
plugged in and charging.
Shows how much charge is left
in the battery.
A treatment was not completed
on this day.
A 20-minute treatment was
completed on this day.
Two-20 minute treatments were
completed on this day.
Three or more 20-minute
treatments were completed on
this day.
A treatment was delivered on this
day, but was less than 20
minutes.
Flashes during use to show you
are treating your fracture.
Counts down from 20 minutes to
show treatment time remaining.
Automatically displays when
countdown timer reaches zero to
show that treatment is complete.
Ireland: 1800 552197 UK: 0800 0516384 3