Ultrasound Gel; Important Things To Know; Exogen Usage; Contraindications - Bioventus EXOGEN Guia Del Usuario

Ultrasound Gel

Important Things to Know

Ultrasound gel (Figure 5) is provided for use with EXOGEN is approved for use by persons that are
EXOGEN. The gel is to be placed on the trans- 18 years or older and skeletally mature. There is
ducer every time you use EXOGEN. The gel lets no maximum age limit to using EXOGEN. The
the ultrasound signal reach your fracture through anticipated education level of an EXOGEN user
your skin. EXOGEN will not work properly if gel is is to read English at an 8th Grade level or
not covering the transducer and you will receive equivalent, and the ability to read and understand
an alert from EXOGEN. Western Arabic numerals. No special previous
experience or skills are needed or expected to be
Only use the gel supplied. Do not use other gels
able to operate EXOGEN. There may be physical
as they may damage the transducer surface or
impairments that result from the presence of a
block the signal. If you need more gel, please
fracture, such as reduced range of motion or
call Customer Service at 1-800-836-4080.
immobility. EXOGEN is expected to be used
Note: Some patients have experienced mild skin with one hand for guiding and holding EXOGEN.
irritation caused by skin sensitivity to the gel. If
Read "Getting Started" (page 5) and "Treating
you feel your skin is sensitive to the gel, you may
Your Fracture" (page 10) before you begin using
change the gel to mineral oil or glycerin.
EXOGEN.

EXOGEN Usage

EXOGEN should be used for 20 minutes per day
Cap
or as prescribed by your doctor. It is important
Nozzle
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 fracture is different and it takes some
fractures longer to heal than others. Call your
doctor if you have questions or concerns about
Bottle
your fracture.
EXOGEN is for single patient use only. EXOGEN
will deliver 300 full 20-minute treatments. If this
number is reached and you are still treating your
fracture under your doctor's direction, contact
Customer Service at 1-800-836-4080 for
instructions.

Contraindications

There are no known contraindications to the use
Figure 5 – Ultrasound Gel
of EXOGEN.
(Part Number: 71034694)
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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, anticoagulant,
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
• Fresh fracture locations other than the distal radius
(end of the large bone in the forearm) or tibial
diaphysis (middle 80% of the large bone in your
lower leg)
• Fresh fractures that are open Grade II or III
(fractures with large wounds) or that require
surgical intervention with internal or external
fixation (screws and/or plates used to hold your
broken bones in place) or that are not sufficiently
stable for closed reduction (manipulation of the
fracture without surgery) and cast immobilization
(cast treatment)

Precautions

Display Symbols and Descriptions

• EXOGEN will not correct or alter post-reduction
Symbol
(when your fracture is initially set and placed in a
cast) aspects of a fracture such as displacement,
angulation or malalignment
• The transducer, strap and gel are not sterile and
placement on an open wound is not advised
• The operation of active, implantable devices, such
as cardiac pacemakers may be adversely affected
by close 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 with EXOGEN
• The cords pose a risk for strangulation. Keep out
of reach of children
• Cell phones, televisions, and other devices using
radio frequency energy may cause interference.
This interference may cause EXOGEN to operate
improperly or stop operating 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
• The safety and effectiveness of EXOGEN when
used for more than one daily 20-minute treatment
period has not been studied. Patients in the clinical
studies were instructed to apply EXOGEN for one
treatment period of twenty-minutes each day
- The age ranges of the patients in the PMA non-
union studies were 17-86. The effect of EXOGEN
therapy on patients outside this age range has
not been studied
- The age ranges of the patients in the PMA
fresh fracture studies were 17-67. The effect of
EXOGEN therapy on patients outside this age
range has not been studied
• The safety and effectiveness of the use of
EXOGEN has been demonstrated for patients
followed up over a period of 6.5 years (78 months)
• When choosing a treatment site ensure that the
site selected allows for full contact of the trans-
ducer face with the skin. Failure to do so may re-
sult in the transducer being only partially coupled
to the skin. This may reduce the effectiveness of
EXOGEN in treating the fracture.
*EXOGEN should be used for only 20 minutes per day, or as prescribed by your doctor.
Name Description
Flashes to show EXOGEN is
Charging Symbol
plugged in and charging.
Shows how much charge is left in
Battery Status the battery.
A 20-minute treatment was not
Calendar X-Mark
completed on this calendar day.
A 20-minute treatment was
Calendar Checkmark
completed on this calendar day.
Calendar Double Two-20 minute treatments were
Checkmark* completed on this calendar day.
Three or more 20-minute
Calendar Double
treatments were completed
Checkmark Plus*
on this calendar day.
Flashes during use to show you
Treatment Symbol
are treating your fracture.
Counts down from 20 minutes to
Countdown Timer
show treatment time remaining.
Automatically displays when count-
Treatment Complete down timer reaches zero to show
that treatment is complete.
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