Bioventus EXOGEN User manual
EXOGEN®User Guide
Read before using your device
EXOGEN Overview
Getting Started
EXOGEN Setup
Tracking Your Treatment
Troubleshooting
EXOGEN Care
Customer Service
EXOGEN Overview 1
Indications for Use 1
EXOGEN Description 1
EXOGEN Device 1
Charger (power supply) 2
Strap 2
Ultrasound Coupling Gel 2
Treatment Card 2
EXOGEN Usage 2
Important Things to Know 3
Contraindications 3
Warnings 3
Precautions 3
Display Symbols and Descriptions 3
Getting Started 4
Charging EXOGEN 4
Recharging EXOGEN 4
Treatment Card Insertion 5
Preparing to Treat Your Fracture 5
Place the Strap 5
If You Have a Cast 5
Add Gel and Place Transducer 6
EXOGEN Setup 8
First Use 8
Hour Setting 8
Treating Your Fracture 9
EXOGEN Cleaning 10
Tracking Your Treatment 11
Track Usage 11
Treatment Data 11
Summary Data 12
Treatment History 13
Pause Treatment History 13
Replacing Your
Treatment Card 14
Troubleshooting 15
EXOGEN Care 16
Operating Conditions 16
Storage 16
EXOGEN Expected Service Life 16
Battery and Charging Safety 16
EXOGEN Disposal 17
Removing the Battery for Disposal 17
Clinical Studies 18
Metals and Implants 18
Mechanism of Action 18
Adverse Events 18
Complications 18
References 18
Technical Information 19
EXOGEN Classications 20
Guidance and
Manufacturer’s Declaration 20
Customer Service 23
Limited Warranty 23
Table of Contents
THIS DEVICE IS NON-STERILE.
It does not require sterilization before use.
EXOGEN Label Symbol Descriptions and Equipment Classication
Information Symbol: refer to User Guide.
Catalog Number
CE Mark: indicates conformity with European Council Directive of 14 June 1993 concerning Medical Devices (93/42/EEC).
Type BF Applied Par t. The transducer, shown in Figure 2 on page 1 is an applied part.
EU: Not for General Waste.
This symbol indicates that EXOGEN should not be disposed of with ordinary household waste at the end of its life. For details on how
to dispose of this device correctly, contact your local government waste disposal agency or your local Bioventus representative.
Manufacturer
This symbol indicates the authorized representative in the European Community.
SN Serial number (rst four digits of the serial number indicate the month and year of manufacture)
WAVEFORM Pulsed Signal
Rx Symbol: Federal Law (U.S.A.) restricts this device to sale, distribution, or use by or on the order
of a physician or properly licensed practitioner. This device is only intended for use by the individual
for whom it is prescribed.
1Customer Service: Australia: 180 0 428 220 Ireland: 180 0 552197 UK: 08 00 0516384
EXOGEN Overview
Indications for Use
EXOGEN Ultrasound Bone Healing System
is indicated for the non-invasive treatment
of osseous defects (excluding vertebra and
skull) that includes:
• Treatment of delayed unions and
non-unions†
• Accelerating the time to heal of fresh
fractures
• Treatment of stress fractures
• Accelerating repair following osteotomy
• Accelerating repair in bone transport
procedures
• Accelerating repair in distraction
osteogenesis procedures
• Treatment of joint fusion
†
A non- union is considered to be
established when the fracture site
shows no visibly progressive signs of
healing.
EXOGEN Description
The EXOGEN Ultrasound Bone Healing
System provides non-invasive therapy for
healing non-unions and accelerating time
to healing of fresh fractures. Internationally,
EXOGEN can be used on both fresh
fractures and non-unions – and both can
be conservatively or surgically treated.
EXOGEN transmits a low-intensity ultra-
sound signal to the fracture site through
coupling gel, with little or no sensation
felt by the patient during the treatment.
Low-intensity pulsed ultrasound has
been shown in in-vitro and in-vivo
studies to stimulate cells to produce
growth factors and proteins that are
important to bone healing.
The patient administers treatment at home
or at work, once daily, for 20 minutes, or as
prescribed by a physician.
EXOGEN automatically 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,
a strap and a Treatment Card. The
EXOGEN device provides the treatment
control circuitry, the battery supply and
monitors the operation of the transducer at
the fracture site. The signal specications
cannot be changed.
Everything you need to treat your fracture is
included in the EXOGEN Ultrasound Bone
Healing System. (See Figure 1). Your
charger may look different from the image
below, depending on the country where
you live. If one of the items in Figure 1
is missing, please contact Customer
Service to receive a replacement.
EXOGEN Device
EXOG EN (Figure 2) features a transducer
at the end of a coiled cord, color screen,
power button, USB charging port, and
Treatment Card por t. The cord and
transducer are not removable from
EXOG EN.
EXOGEN contains the internal electronics
and battery. It checks the ultrasound signal
to make sure EXOGEN works properly.
The transducer sends low-intensity pulsed
ultrasound to the fracture site through the
gel. EXOGEN can also sense if gel
is present on the transducer surface.
EXOGEN stores and displays your daily
use. This data is available to you and your
physician.
EXOGEN has a mini-USB charging port to
allow you to recharge the battery. EXOGEN
will not communicate with any other
electrical devices.
Figure 1 – EXOGEN Ultrasound Bone Healing System
Figure 2 – EXOGEN Device (Part #71034451)
EXOGEN OVERVIEW
Treatment card Gel
Charger
EXOGEN Device
Strap
Card Port (not shown)
Color Screen
Button
Transducer
Coiled Cord
USB Charging
Port
2 3Customer Service: Australia: 180 0 428 220 Ireland: 180 0 552197 UK: 08 00 0516384
Charger (power supply)
EXOGEN is powered by a rechargeable
battery. A charger (Figure 3) is included
with EXOGEN. Your charger may look
different from the image below, depending
on the countr y where you live. Only use this
supplied charger with EXOGEN. Do not
plug other chargers into EXOGEN. Other
chargers may cause injury to you or others
near EXOGEN as well as damage to the
charger. The use of chargers, transducers
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
of your country:
Australia: Part #71034463
Europe: Part # 71034462
United Kingdom: Part #71034461
Read more about how to charge EXOGEN
in “Getting Started” on page 4.
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 t most fracture locations. If
your strap does not t the location of your
fracture, please contact Customer Ser vice
to nd out if there is another strap which
may t better.
Ultrasound Coupling Gel
Ultrasound coupling gel (Figure 5) is
provided for use with E XOGEN. The
gel is to be placed on the transducer
every time you use EXOGEN. The gel
lets the ultrasound signal reach your
fracture through your skin. EXOGEN
will not work properly if gel is not covering
the transducer and you will receive an aler t
from EXOG EN.
Only use the supplied gel. Do not use other
gels as they may damage the transducer
surface or block the signal. If you need
more gel, please call Customer Ser vice.
Note: Some patients have experienced mild
skin irritation caused by skin sensitivity to
the gel. If you feel your skin is sensitive to
the gel, you may change the gel to mineral
oil or glycerin.
Treatment Card
EXOGEN comes with a Treatment Card
(Figure 6). Based on your physician’s
prescription, the amount of treatments on
your card may vary. Once the card is
inser ted, EXOGEN will show you how
many treatments you have used on your
card. E XOGEN will only work properly
if the card is inserted. The card must
remain inside of EXOGEN until all
treatments are used.
Only use the Treatment Card supplied by
Bioventus. Do not inser t other cards in
EXOGEN. Other cards may become
damaged when inserted into EXOGEN.
If you have not received a Treatment Card
with your EXOGEN, contact Customer
Service.
A selection of Treatment Cards are
available depending on your country
of residence:
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
benet 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 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 Star ted” (page 4) and
“Treating Your Fracture” (page 9)
before you begin using E XOGEN.
Contraindications
There are no known contraindications to the
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 insufciency
(poor blood supply), abnormal skin
sensitivity (very sensitive skin), sensory
paralysis (lack of sensation), alcoholism
and/or nutritional deciency.
• Individuals receiving steroid, anti-
coagulant, prescription non-steroidal
anti-inammatory, 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
• EXOGEN will not correct or alter
post-reduction (when your fracture
is initially set and placed in a cast)
aspects of a fracture such as displace-
ment, 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 radiofrequency energy
may cause inter ference. 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 Par t 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.
• 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.
• 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
transducer being only partially coupled
to the skin. This may reduce the
effectiveness of E XOGEN in treating the
fracture.
Display Symbols and
Descriptions
Mini USB plug
Figure 3 – EXOGEN Charger
Figure 4 – EXOGEN Strap
(Part Number: 71034622)
Figure 5 – Ultrasound Coupling Gel
(Part Number: Part #71034694)
Figure 6 – Treatment Card
Symbol Name Description
Charging Symbol Flashes to show EXOGEN is
plugged in and charging.
Battery Status Shows how much charge is left
in the battery.
X- Mark A treatment was not completed
on this day.
Checkmark A 20-minute treatment was
completed on this day.
Double Checkmark* Two-20 minute treatments were
completed on this day.
Double Checkmark
Plus*
Three or more 20-minute
treatments were completed on
this day.
Partial Treatment
A treatment was delivered on this
day, but was less than 20
minutes.
Treatment Symbol Flashes during use to show you
are treating your fracture.
Countdown Timer Counts down from 20 minutes to
show treatment time remaining.
Treatment Complete
Automatically displays when
countdown timer reaches zero to
show that treatment is complete.
EXOGEN OVERVIEW
EXOGEN OVERVIEW
Port
Cap
Strap Cap
Nozzle
Bottle
Metal Contacts
Treatment Card
*EXOG EN should be used f or only 20 minutes p er day, or as pre scribed by your doctor.
4 5Customer Service: Australia: 180 0 428 220 Ireland: 180 0 552197 UK: 08 00 0516384
Getting Started
Charging EXOGEN
EXOGEN has a rechargeable lithium-ion
battery. A fully-charged battery delivers
approximately ve 20-minute treatments.
It takes about 5 hours to fully charge a
discharged EXOGEN battery.
WARNING: To avoid the risk of electric
shock, EXOGEN must only be connected
to a supply mains with protective earth (a
3-prong electrical outlet). Do not use any
adapters or extension cords to charge
EXOGEN. Only plug the charger into
an UL listed electrical outlet.
Charge EXOGEN before you begin a
treatment or turn EXOGEN on. Follow the
steps, on the right, to charge EXOGEN.
As you use EXOGEN, the symbol will
change to show the reduced battery life.
See Figure 7.
You may charge E XOGEN at any time,
whether it is on or off. When the battery
level is low, you must charge EXOGEN
before your next treatment.
You can charge EXOGEN and treat your
fracture at the same time. Use the charger
provided in the EXOGEN Ultrasound Bone
Healing System.
Do not connect EXOGEN to any other
electrical equipment. EXOGEN is unable to
communicate with any other electrical
equipment.
BATTERY PROBLEM?
Try fully charging EXOGEN with the
charger provided. If your EXOGEN unit
still does not work, call Customer Service.
Do not try to x EXOGEN yourself.
Recharging EXOGEN
Check the charge level on EXOGEN
following treatment. If the battery is low,
charge EXOGEN with the supplied charger.
See the “Charging EXOGEN” (page 4)
for instruction on charging EXOGEN.
Preparing to Treat Your
Fracture
To treat your fracture you will need
EXOGEN, the gel and strap. If you have a
cast around your fracture, you will not need
the strap.
Your doctor may have marked your fracture
site with an ‘X’, or told you where to treat
your fracture. This is the spot to place the
transducer to treat your fracture. Contact
your doctor if you are not sure where to
treat your fracture.
Before you begin, check the cable and
the transducer for any cracks or signs
of damage. If damaged, do not use
EXOGEN and contact Customer Ser vice.
Precaution: The transducer, strap and gel
are not sterile and placement on an open
wound is not advised.
Place the Strap
If You Have a Cast
Charging symbol
Battery status
1. Find the USB cover on the
left side of EXOGEN.
2. Pull the tab down to open
the USB cover. 3. Plug the end of the charger into an
electrical outlet. Plug the USB plug
end of the charger into the USB port.
5. You will see the charging symbol
(white lightning bolt) and battery
status symbol ashing in the corner
of the screen. This lightning bolt
charging symbol tells you EXOGEN
is charging. Charge EXOGEN until
a fully-charged battery is shown
by the battery status.
6. When charging is complete, remove
the USB plug from EXOGEN, close
the USB cover and unplug the charger
from the wall.
Figure 7 – Battery Status Symbols
1. Find the cover on the right
side of EXOGEN.
2. Pull down the tab to open the cover. 3. Put the Card into the por t, metal
contacts facing up, and entering rst.
Press the card into EXOGEN until the
card clicks into place.
4. Close the Cover
5. Leave your Card in EXOGEN until
all your treatments have been used. If
you have used all the treatments on your
card and you feel your fracture has still
not healed, contact your doctor.
1. Position the strap with the cap
facing up.
2. Pull the long end of the strap through
the plastic loop, as shown.
3. Use 2 ngers to squeeze the cap tabs
together to open the cap.
4. Slide on the strap and place the port
over the ‘X’ mark on your skin.
5. Tighten the strap by pulling on the
long end. Fasten the strap in place.
Do not make the strap too tight!
1. Your cast will have a plastic port with
cap built into it.
2. Use 2 ngers to squeeze the cap tabs
together to open the cap.
3. Pull out the round felt plug inside
the opening.
GETTING STARTED
GETTING STARTED
USB Cover
(closed)
USB Cover
(open)
Pull down at
tab to open
USB plug of charger
Full Charge
Partial Charge
Partial Charge
Low Charge
Cover
(open)
Cover
(closed)
Pull down at
tab to open
Treatment Card
(metal contacts
faci ng u p)
Treatment Card Insertion
6 7Customer Service: Australia: 180 0 428 220 Ireland: 180 0 552197 UK: 08 00 0516384
Add Gel and Place Transducer
Note: Some patients have experienced mild
skin irritation caused by skin sensitivity to
the gel. If you feel your skin is sensitive to
the gel, you may change the gel to mineral
oil or glycerin.
Add gel on the transducer ever y time you
treat your fracture.
1. Take the cap off the gel bottle.
2. Hold the transducer so the cord is
down and the smooth side of the
transducer is up.
3. Press down on the gel bottle nozzle
to put gel on the smooth side of the
transducer. You only need one full
pump of gel on the transducer.
Note: The rst time you use the gel,
you may need to pump a few times
to start the gel owing.
4. Put the transducer, gel side down, into
the port. The gel will be touching the
skin over your treatment site.
5. Align the cord coming out of the
transducer with the notch in the
cap. Snap the cap shut on the
strap or the cast.
6. Replace the cap on the gel bottle.
GETTING STARTED
8 9Customer Service: Australia: 180 0 428 220 Ireland: 180 0 552197 UK: 08 00 0516384
EXOGEN Setup
First Use
EXOGEN tracks how often the system is
used. The current hour needs to be set
to make sure the tracking is accurate.
The hour must be set once, the very rst
time EXOGEN is turned on.
Hour Setting
1. Press the button once. The hour and
AM/PM show on the screen. This may
or may not be your current hour. The
clock must be set to your current
hour. For example, if your time is
anywhere between 2:00 PM and
2:59 PM, set the hour to 2 PM.
2. Press the button once to advance the
time one hour. Press the button, one
press at a time, until the correct hour
and AM/PM is displayed on the
screen.
3. Press and hold button until you
see the hour conrmation screen.
This indicates that the hour has been
set on EXOGEN. You do not need to
set the minutes. After 5 seconds, the
device will beep and automatically
turn off.
Contact Customer Service if you
have incorrectly set the time.
8AM 9AM 10 AM
www.exogen.com
®
8AM
10 AM 10 AM
EXOGEN SETUP
Press button Start-up screen Time set
Flashing time set screen Press button once to
advance hour
Press button once to
advance hour
Current hour Conrmation Screen
Press &
hold
Treating Your
Fracture
Start Treatment
Hold EXOGEN in your hand to view the
screen, or set EXOGEN down on a nearby
at surface. Perform the following steps to
begin treatment:
1. Press the button on EXOGEN.
EXOGEN beeps and the start-up
screen appears for 2 seconds.
2. A treatment history screen appears
on the screen for 5 seconds. It shows
your treatment summary. For more
information on the screen, see
“Tracking Your Treatment” on
pa g e 11.
3. Next, the 20-minute countdown timer
appears on the screen. EXOGEN
automatically begins the ultrasound
treatment. A treatment symbol ashes
as the timer counts down. This means
you are treating your fracture. (Note:
To stop EXOGEN in the middle of the
20-minute treatment, press and hold
the button until EXOGEN turns off.)
If your EXOGEN has an error during
treatment, see “Troubleshooting” on
page 15.
4. When the countdown timer reaches
zero, EXOGEN beeps and shows
the treatment complete checkmark.
The treatment complete checkmark
displays for 5 seconds. Then,
EXOGEN beeps and turns
itself off.
Note: Do not remove the Treatment Card
while treating your fracture.
www.exogen.com
®
20:00
=
=
=
=
®
%
9 10 11 12 13 14
15
21 3 4 5 6 7
8
16 17 18 19 20 21
22 23 24
36 37 38 39 40 41 42
30 31 32 33 34 35
25 26 27 28
29
0
0
0
0/60 0
1-42
Press button Start-up screen
Treatment History Screen Treatment countdown
Completion
EXOGEN SETUP
10 11Customer Service: Australia: 180 0 428 220 Ireland: 180 0 552197 UK: 08 00 0516384
EXOGEN Cleaning
After treatment is complete, you must clean
the transducer after each use.
If You Have a Cast
Follow steps 1-3 (above), and then do the
following instead of step 4:
1. Squeeze tabs to open the cap on
the port.
2. Gently remove the transducer from the
port. Do not yank the cord! Pulling hard
on the cord to remove the transducer
may cause the cord to detach from the
transducer and require your EXOGEN
to be ser viced.
3. Wipe of f any gel on the transducer
with a soft cloth. You do not need
any cleaning uid.
4. Remove the strap and clean any gel from
your skin and strap with a soft cloth.
5. Place EXOGEN, the strap and gel
back into the carrying case until you
are ready to treat again.
4. Carefully clean any gel from your cast,
skin and port with a soft cloth.
5. Inser t the felt plug, with the tab up,
into the port. This plug helps prevent
swelling in the cast when you are not
using EXOGEN.
6. Snap the cap shut.
7. Place EXOGEN and the gel back into
the carrying case until you are ready
to treat again.
Tracking Your
Treatment
Track Usage
EXOGEN tracks how often you use it.
Your usage will be shown on the screen
which displays 42 treatment days on each
screen. There are two parts to the screen.
The top part shows a treatment data grid
and the bottom part shows the treatment
summary information. See Figure 8.
EXOGEN SETUP
=
=
=
=
®
%
15 16 17 18 19 20 21
22 23 24
36 37 38 39 40 41 42
30 31 32 33 34 35
25 26 27 28
29
8
1
4
9/250 64
12 13 14
1-42
Treatment Data
The Treatment History Screen shows your treatment summary. Today’s day will
have a purple box around it. EXOGEN will mark ever y day with one of the following
symbols: X-mark, checkmark, double checkmark*, double checkmark plus*, or
partial treatment.
X-mark You did not complete a treatment
on this day.
You completed a 20 minute treatment
on this day.
You completed two 20 minute treatments
on this day.
You completed three or more 20 minute
treatments on this day.
Checkmark
Double checkmark
Double checkmark plus
Symbol Name Description
You treated for less than 20 minutes
on this day.
Partial treatment
Treatment
data
Summary
data
Figure 8 – Treatment History Screen
*EXOGEN should be used for 20 minutes per day or as prescribed by your doctor.
TRACKING YOUR TREATMENT
12 13Customer Service: Australia: 180 0 428 220 Ireland: 180 0 552197 UK: 08 00 0516384
Summary Data Treatment History
After using E XOGEN over time, you
may want to view your treatment history and
show it to your doctor. EXOGEN lets you
view your treatment history without having
to star t a treatment. You can start EXOGEN
in “Treatment History ” mode. You cannot
enter “Treatment History” mode when
EXOGEN is being charged. To view
your treatment history, perform the
following steps:
1. EXOGEN must be “OFF” and unplugged
from the charger. Press and hold the
power button until the Treatment History
Start screen appears.
2. The recent treatment history appears
for 5 seconds.
3. This continues until your entire treatment
history has been shown.
4. After the last treatment history screen
displays for 5 seconds, EXOGEN beeps
and turns itself off. You may exit the
Treatment History mode at any time
by pressing and holding the button
until EXOGEN turns itself off.
=
=
=
=
®
%
9 10 11 12 13 14
15
21 3 4 5 6 7
8
16 17 18 19 20 21
22 23 24
120 121 122 123 124 125 126
30 31 32 117 118 119
25 26 27 28
29
116
0
0
116 / 2 5 0 100
85-126
=
=
=
=
®
%
9 10 11 12 13 14
15
21 3 4 5 6 7
8
16 17 18 19 20 21
22 23 24
36 37 38 39 40 41 42
30 31 32 33 34 35
25 26 27 28
29
116
0
0
116 / 2 5 0 100
43-84
=
=
=
=
®
%
9 10 11 12 13 14
15
21 3 4 5 6 7
8
16 17 18 19 20 21
22 23 24
36 37 38 39 40 41 42
30 31 32 33 34 35
25 26 27 28
29
116
0
0
116 / 2 5 0 100
1-42
®
TRACKING YOUR TREATMENT
TRACKING YOUR TREATMENT
Treatment HIstor y Start Screen Treatment History Screen 1
Treatment History Screen 2 Treatment History Screen 3
=
=
=
®
%
50
1
51/250 83
=
8
Fifty 20-minute
treatments delivered
1 cumulative
partial treatment
(sum of two 10-minute
partial treatments)
51 treatments
used on the card
250 treatments
assigned to card
% compliance
50/60
8 missed treatment days
Treatment Days
Cumulative Partial
Treatments
Treatment Card
Cumulative Partial Treatments are the
number of partial treatment minutes
that add together to count against
your treatment card.
When the sum of your partial
treatment reaches 20 minutes,
it will count as one full treatment
against your card.
=Missed Treatment Days
Missed Treatment Days are the
number of days that you did not
complete a 20-minute treatment.
This is the total of all days marked
with an X.
Treatment days are the number of
days that you have completed a
20-minute treatment.
Treatment Card is the ratio of the
number of 20-minute treatments used
versus the number of treatments
assigned to the Treatment Card
inserted into your EXOGEN device.
The total number of treatments used
is the sum of the Treatments ( )
and Cumulative Partial Treatments
( ).
Compliance Percentage
Compliance Percentage is the number
of days a full treatment was delivered
divided by the number of total days
since you began using EXOGEN.
%
100
If you have EXOGEN for 60 days, but forgot to treat 8 of those days,
and 2 days you only treated for 10 minutes, you will have the following
numbers:
Pause Treatment History
You can pause the treatment histor y to
view it for longer than 5 seconds.
To pause the treatment history, perform
the following steps:
1. When you see the treatment history
screen, press the button to pause.
2. The treatment history will pause, and
a pause symbol ashes.
3. Press the button again to un-pause
the treatment history and continue.
4. The treatment history screen will
automatically un-pause after 2
minutes and continue.
=
=
=
=
®
%
9 10 11 12 13 14
15
21 3 4 5 6 7
8
16 17 18 19 20 21
22 23 24
36 37 38 39 40 41 42
30 31 32 33 34 35
25 26 27 28
29
0
0
0
0/60 100
1-42
Customer Service: Australia: 180 0 428 220 Ireland: 180 0 552197 UK: 08 00 051638414
Replacing Your
Treatment Card
If you have used all the treatments on your
Treatment Card and you feel your fracture
has still not healed, please contact your
doctor. If you are still under your doctor’s
care, they may prescribe you another
Treatment Card. To order a replacement
Treatment Card, please contact Customer
Service. Once you receive your replace-
ment Treatment Card follow the instructions
to replace your old card.
Troubleshooting
EXOGEN will alert you if something is not working properly. EXOGEN will beep and display an
alert screen. See the table below for examples of alerts and what to do if you get an alert.
1. Make sure your device is turned off
and not plugged into a power source.
2. Find the cover on the right side
of EXOGEN.
3. Pull down the tab to open the cover. 4. Press the Treatment Card inward until
it clicks and then release your nger
from the Treatment Card. The card
should eject from the device far enough
for you to grab it.
5. Remove the Treatment Card from
EXOGEN and discard.
6. Put the new Treatment Card into
the port, metal contacts facing up,
and entering rst. Press the card into
EXOGEN until the card clicks into place.
7. Close the cover.
8. Leave your Treatment Card in
EXOGEN until all your treatments
have been used.
TRACKING YOUR TREATMENT
Alerts What does this mean? What should I do?
Gel Error: The countdown timer stops, EXOGEN beeps and displays
the yellow “Add Gel” screen. There is not enough gel on the transducer.
Add more gel to the transducer. See “Add Gel and Place Transducer” on
page 6. After you add more gel, place the transducer back over the fracture
using the strap or cast port. EXOGEN will stop beeping and the countdown
timer will restart. If EXOGEN still beeps and the “Add Gel” screen remains,
add more gel.
Low Battery: You are not able to start treatment or view histor y. EX-
OGEN beeps and displays the yellow “Low Battery” screen. The battery
level is very low. You must charge EXOGEN.
Plug EXOGEN into a power source with the provided charger. It is safe to
charge EXOGEN and treat at the same time.
See “Charging EXOGEN” on page 4.
Contact Customer Service: EXOGEN beeps and displays the yellow
“Contact Customer Service” screen. EXOGEN has detected that it is
not working properly.
Call Customer Service. Do not try to x EXOGEN yourself.
Treatment Card Error: Your Treatment Card is missing, or is
improperly inserted.
Inser t your card if it is not already inserted. If the card is inserted, remove it and
reinsert it according to the directions in the Treatment Card Insertion section on
page 5. If you are still having trouble, please contact Customer Service.
60/60
No Remaining Treatments on the Treatment Card: EXOGEN
beeps and displays the yellow “No Remaining Treatments” screen. No
treatments remain on the Treatment Card that is currently inserted in
the device.
If you are still being instructed by your doctor to treat your fracture with
EXOGEN, call Customer Ser vice for instructions.
End of Service: EXOGEN beeps and displays the yellow “No Remain-
ing Treatments” screen. EXOGEN has reached the end of its expected
service life (343 treatments). Note: Your Treatment Card may still have
treatments remaining but the number of treatments used and the number
of treatments available on the card will not be displayed.
If you are still being instructed by your doctor to treat your fracture with
EXOGEN, call Customer Ser vice for instructions.
Problems What does this mean? What should I do?
Blank screen,
EXOGEN does
not turn on.
The battery may be completely discharged or your EXOGEN
has malfunctioned.
Plug in charger to EXOGEN and fully charge your battery. If EXOGEN still does
not respond, contact Customer Service.
The battery area on
EXOGEN or the
battery charger gets
excessively warm.
The battery or charger is malfunctioning. Stop using EXOGEN and contact Customer Service.
TROUBLESHOOTING
15
Cover
(open)
Cover
(closed)
Pull down at
tab to open
Treatment Card
(metal contacts
faci ng u p)
Customer Service
Australia: 1800 428 220
Ireland: 1800 552 197
UK: 0800 0516384
00800 02 04 06 08
16 17Customer Service: Australia: 180 0 428 220 Ireland: 180 0 552197 UK: 08 00 0516384
EXOGEN Care
EXOGEN should be handled with care.
Please note the following:
• Use only a clean soft cloth, paper towel,
or cotton swab to clean EXOGEN, the
transducer and the strap. Do not use
cleaning agents or solvents on any of the
components of the system
• Do not attempt to modif y, disassemble or
repair the EXOGEN. There are no user
serviceable parts inside EXOGEN
• Exercise care when handling the
transducer as rough handling may
scratch the transducer face and
cause E XOGEN not to work properly
• If any par ts of EXOGEN or its
accessories are damaged, do not use
EXOGEN. Please contact Customer
Service to return your EXOGEN for
servicing
• EXOGEN is classied as an IP-22
device. The IP-22 classication
indicates that EXOGEN provides
- Protection against the access of ngers
or similar objects from the internal
components of EXOGEN
- Protection against the harmful ingress
of water into the enclosure of EXOGEN
when tilted up to 15° from normal
position
• The EXOGEN transducer is classied
as an IP- 67 component. The IP-67
classication indicates that the
transducer is:
- Dust-tight
- Will not be damaged by water under
dened conditions of pressure and time
(up to 1 meter under water)
• Never put EXOGEN in or under water
Operating Conditions
EXOGEN should be operated within:
Ambient temperature range: 5°C to 32°C
(41°F to 89°F)
Relative humidity range: 15% to 75%
(non-condensing)
Atmospheric pressure range: 700 hPA to
1060 hPA
Interference with proper operation of
EXOGEN may occur in the vicinity of
equipment such as por table and mobile
communication units marked with this
symbol . If abnormal operation
of EXOGEN is observed, attempt to
relocate or reorient EXOGEN in relation
to the interfering equipment until the
interference stops.
The charger will function with an input
voltage range from 100 VAC -240 VAC and
has an operating frequency range is from
50/60 Hz. The charger output is 5 VDC.
EXOGEN and accessories should be
stored and transported within:
Ambient temperature range: 0°C to 32°C
(32°F to 89°F)
Relative humidity range: 15% to 75%
Atmospheric pressure range: 700 hPA
to 1060 hPA
If EXOGEN is stored or transported in
temperatures outside this range, allow
EXOGEN time to come to room tempera-
ture for at least 30 minutes before
operating. The least favorable working
conditions for EXOGEN are +32oC at
75% Humidity.
Storage
• To prevent damage to EXOGEN and its
accessories, store EXOGEN in its
carrying case while not in use
• Do not store EXOGEN near radiators or
extreme heat
• Do not expose EXOGEN to extreme tem-
peratures or the internal electronic
components may be damaged
• As with any home electronic device,
protect EXOGEN from impact, exposure
to moisture, liquid spills, sand, dir t or
debris
After your fracture has healed or prior to
long-term storage of EXOGEN, remove the
battery to prevent leakage of the battery.
EXOGEN Expected
Service Life
The expected service life of EXOGEN
and its accessories is 343 treatments
(6860 minutes). Once EXOGEN delivers
343 treatments, it will not provide further
treatment.
Battery and
Charging Safety
Battery
• Do not attempt to replace the lithium-ion
battery
• Do not attempt to replace the lithium-ion
battery with non-approved batteries.
Incorrect replacement of the battery
could result in damage to EXOGEN. The
battery should only be serviced by
Bioventus trained personnel
• Be sure to use only the USB battery
charger provided with the system (see
page 2). Other batter y chargers may
cause battery overheating and damage
the battery, EXOGEN, the battery
chargers or the user
• Do not use an extension cord with the
battery charger as this may cause
overheating
• Do not use the battery charger with other
devices as this may damage the batter y
charger and/or the other device
• If the batter y area on EXOGEN
or the batter y charger becomes
excessively warm, discontinue using
and contact Customer Service.
Charging
• Charge the battery to at least 25%
capacity (one bar) before attempting to
perform a treatment when the battery is
used for the rst time or after prolonged
storage
• The battery will charge whether
EXOGEN is turned off or on
• If the batter y power decreases quickly
even after recharging for many hours
contact Customer Service.
Do not recharge the bat tery in any of the
following locations:
• Where the ambient temperature is below
0ºC or above 45ºC
• Damp or wet location and/or near water
• Outside (use indoors only)
• Within the reach of small children
• With the battery charger cable stretched
across a oor or other areas where
people walk that would cause a tripping
hazard
• On oor or other area where EXOGEN
or the cable may be damaged by people
walking on them
EXOGEN Disposal
EXOGEN is designed for single patient
use only. For details on how to dispose of
EXOGEN correctly, contact your local
government waste disposal agency or
Customer Service.
Caution: Dispose of the battery properly
to prevent environmental contamination
and possible human injury.
Warning: Do not throw any par t of
EXOGEN into re.
Removing the Battery for
Disposal
Only remove the battery from EXOGEN for
disposal. To remove the battery, follow
these steps:
1. Make sure EXOGEN is not plugged in
to an electrical outlet.
2. Turn EXOGEN screen side down and
nd the battery door screw.
3. Use a screwdriver to remove the
battery door screw.
4. Remove the battery door by lif ting
up at the tab.
8. Remove and properly dispose of
the battery according to your local
or national refuse laws.
5. Gently lift the battery out of the
compartment.
6. Follow the red and black wires to
nd the battery connector.
7. Push the small tab in and pull up
to unlock the batter y connector.
EXOGEN CARE
EXOGEN CARE
Push small
tab inward to
unlock connector
Gently lift
battery out
of compartment
18 19Customer Service: Australia: 180 0 428 220 Ireland: 180 0 552197 UK: 08 00 0516384
Clinical Studies
The EXOGEN Ultrasound Bone Healing
System has been evaluated for osseous
defect healing in a number of clinical
studies1-39. These studies have demon-
strated acceleration of fresh fracture by
38% and a non-union heal rate of 86%.
Metals and
Implants
Clinical data indicates that healing rates
and acceleration of osseous defect repair is
not affected by internal or external metal
xation. Several reference articles have
focused on conventional therapeutic
ultrasound’s effect on surgical metallic,
biodegradeable and bioresorbable implants
and conclude there are no untoward
effects13, 40- 45. EXOGEN low intensity pulsed
ultrasound is not capable of penetrating
metal - when treating osseous defects with
plate xation, place the transducer over the
fracture site but not directly over the plate.
Mechanism of
Action
Four review articles12, 46-4 8 have assessed the
clinical and basic science evidence for the
EXOGEN Ultrasound Bone Healing System.
Their analyses suggested the EXOGEN
Ultrasound Bone Healing System induced
cellular reactions at each phase of fracture
healing from inammation through to
endochondral ossication and remodelling.
Adverse Events
Unlike conventional (physical therapy)
ultrasound devices, EXOGEN is incapable
of producing harmful temperature increases
in body tissue49. The ultrasound output
intensity of EXOGEN is 30 mW/cm2and is
typically only 1% to 5% of the output
intensity of conventional therapeutic
ultrasound devices. The ultrasound
intensity is comparable to diagnostic
ultrasound (1 to 50 mW/cm2), such as the
intensities used in obstetrical sonogram
procedures (fetal monitoring). In addition,
there is no evidence of non-thermal adverse
effects (cavitation).
Complications
No device-related adverse reactions or
medical complications related to the use of
EXOGEN were reported during the clinical
studies. Some patients have experienced
mild skin irritation caused by skin sensitivity
to the coupling gel. If you feel your skin is
sensitive to the gel, you may change the
coupling medium to mineral oil or glycerin.
In the distal radius study, one patient
complained of pain during treatment but
they no longer had the pain by the next
follow up visit; and one patient, complaining
of pain, withdrew from the study.
References
1. Cook , Ryaby JP, McCabe J, Frey JJ,
Heckman JD, Kristiansen TK. Acceleration of
tibia and distal radius fracture healing in
patients who smoke. Clin Orthop Relat Res.
1997;337:198-207.
2. Coughlin MJ, Simth BW, Traughber P. The
evaluation of the healing rate of subtalar
arthrodeses, part 2: The effect of low-intensity
ultrasound stimulation. Foot & Ankle
International. 2008:29;970-977.
3. Duarte LR. University of Sao Paulo, Brazil,
unpublished data presented Societe
Internationale de Chirurgie Orthopedique
et de Traumatologie (SICOT).
4. El-Mowa H, Mohsen M. The effect of
low-intensity pulsed ultrasound on callus
maturation in tibial distraction osteogenesis.
Int Orthop. 2005;29:121-124.
5. Frankel VH, Mizuno K. Management of
nonunion with pulsed, low-intensity
ultrasound therapy-international results.
Surg Technol Int. 2001;X:1-6.
6. Frankel VH. Results of prescription use
of pulsed ultrasound therapy in fracture
management. Surg Technol Int. 1998;VII:
389-393.
7. Fujioka H, Tanaka J, Yoshiya S, Tsunoda M,
Fujita K, Matsui N, Makino T, Kurosaka M.
Ultrasound treatment of nonunion of the
hook of the hamate in sports activities.
Knee Surg Sports Traumatol Arthrosc.
2004;12(2):162-164.
8. Fujioka H, Tsunoda M, Noda M, Matsui N,
Mizuno K. Treatment of ununited fracture of
the hook of hamate by low-intensity pulsed
ultrasound: a case report. J Hand Surg.
2000;25(1):77-79.
9. Furue Y. The effect of low-intensity pulsed
ultrasound for treatment of nonunion.
Orthopaedic Surgery and Traumatology
(Japanese language). 2000;43(3):231-235.
10. Gebauer D, Mayr E, Orthner E, Ryaby JP.
Low-intensity pulsed ultrasound: effects on
nonunions. Ultrasound Med Biol.
2005;31:1391-1402.
11. Gold SM, Wasserman R. Preliminary results
of tibial bone transports with pulsed low
intensity ultrasound (Exogen).
J Orthop Trauma. 2005;19:10-16.
12. Hadjiargyrou M, McLeod K, Ryaby JP, Rubin
C. Enhancement of fracture healing by low
intensity ultrasound. Clin Orthop Relat Res.
1998;(355S):S216-229.
13. Handolin L, Kiljunen V, Arnala I, Pajarinen J,
Partio EK, Rokkanen P. The effect of low
intensity ultrasound and bioabsorbable
self-reinforced poly L-lactide screw xation
on bone in lateral malleolar fractures. Arch
Orthop Trauma Surg.125(5):317-21.
14. Heckman JD, Ryaby JP, McCabe J, Frey JJ,
Kilcoyne RF. Acceleration of tibial fracture-
healing by non-invasive, low-intensity pulsed
ultrasound. J Bone Joint Surg. 1994;76-
A(1):26-34.
15. Jones CP, Coughlin MJ, Shurnas PS.
Prospective CT scan evaluation of hindfoot
nonunions treated with revision surgery and
low-intensity ultrasound stimulation. Foot &
Ankle International. 2006;27;229-235.
16. Katsuki M, Mikami J, Matsuno T. Clinical
results of sonic accelerated fracture healing
system for upper extremity diseases. Journal
of Japanese Society for Surgery of the Hand.
2002;19(5):601-605.
17. Kristiansen TK, Ryaby JP, McCabe J, Frey
JJ, Roe LR. Accelerated healing of distal
radial fractures with the use of specic,
low-intensity ultrasound. J Bone Joint Surg.
1997;79-A(7):961-973.
18. Lerner A, Stein H, Soudry M. Compound
high-energy limb fractures with delayed
union: our experience with adjuvant
ultrasound stimulation (Exogen). Ultrasonics.
2004;42(1-9):915-917.
19. Leung KS, Lee WS, Tsui HF, Liu PP, Cheung
WH. Complex tibial fracture outcomes
following treatment with low-intensity
pulsed ultrasound. Ultrasound Med Biol.
2004;30:389-395.
20. Mayr E, Frankel V, Rüter A. Ultrasound-an
alternative healing method for nonunions?
Arch Orthop Trauma Surg. 2000;120:1-8.
21. Mayr E, Laule A, Suger G, Rüter A, Claes L.
Radiographic results of callus distraction
aided by pulsed low-intensity ultrasound.
JOrthop Trauma. 2001;15(6):407-414.
22. Mayr E, Möckl C, Lenich A, Ecker M, Rüter A.
Is low intensity ultrasound effective in treating
disorders of fracture healing? Unfallchirurg.
2002;105:108-115.
23. Mayr E, Rudzki MM, Borchardt B, Haüsser H,
Rüter A. Does pulsed low intensity ultrasound
accelerate healing of scaphoid fractures?
Handchir Mikrochir Plast Chir. 2000;32:
115-122.
24. Mayr E, Wagner S, Ecker M, Rüter A.
Ultrasound therapy for nonunions
(pseudarthrosis): three case reports.
Unfallchirug. 1999;102(3):191-196.
25. Narasaki K. Low intensity ultrasound
treatment of nonunion and delayed union
cases. Orthopaedic Surgery and
Traumatology (Japanese language).
2000;43(3):225-230.
26. Nolte PA, Klein-Nuland J, Albers GHR, Marti
RK, Semeins CM, Goei SW, Burger EH.
Low-intensity ultrasound stimulates in vitro
endochondral ossication. J Orthop Res.
2001;16(2):16-22.
27. Nolte PA, van der Krans A, Patka P, Janssen
IMC, Ryaby JP, Albers GHR. Low-intensity
pulsed ultrasound in the treatment of
nonunions. J Trauma. 2001;51(4):693-703.
28. Pigozzi F, Moneta MR, Giombini A, Giannini
S, Di Cesare A, Fagnani F, Mariani PP.
Low-intensity pulsed ultrasound in the
conservative treatment of pseudoarthrosis.
Journal of Sports Medicine and Physical
Fitness. 2004;44:173-178.
29. Pilla AA, Figueiredo M, Nasser PR, Alves JM,
Ryaby JT, Klein M, Kaufmann JJ, Siffert RS.
Acceleration of bone-repair by pulsed sine
wave ultrasound: animal. Clinical and
mechanistic studies. In Electromagnetics in
Biology and Medicine, ed. by CT Brighton
and SR Pollock, San Francisco Press.
331-341, 1991.
30. Romano C, Messina J, Meani E.
Low-intensity ultrasound for the treatment of
infected nonunions. In: Agazzi M, Bergami
PL, Cicero G, Gualdrini G, Mastorillo G,
Meani M, Mintina S, Soranzo ML, editors.
Guarderni di infezione osteoarticolari.
1999;83-93.
31. Sato W, Matsushita T, Nakamura K.
Acceleration of increase in bone mineral
content by low-intensity ultrasound energy
in leg lengthening. J Ultrasound Med.
1999;18:699-702.
32. Strauss E, Gonya G. Adjunct low intensity
ultrasound in charcot neuroarthropathy. Clin
Orthop Relat Res. 1998;349:132-138.
33. Strauss E, Ryaby JP, McCabe JM. Treatment
of Jones’ fractures of the foot with adjunctive
use of low-intensity pulsed ultrasound
stimulation. J Orthop Trauma.
1999;13(4):310.
34. Tsumaki N, Kakiuchi M, Sasaki J, Ochi T,
Yoshikawa, H. Low-intensity pulsed
ultrasound accelerates maturation of callus
in patients treated with opening-wedge high
tibial osteotomy by hemicallotasis. J Bone
Joint Surg Am. 2004;86-A:2399-2405.
35. Uchiyama Y, Nakamura, Y, Mochida J,
Tamaki T. Effect of Low-Intensity Pulsed
Ultrasound Treatment for Delayed and
Non-union Stress Fractures of the Anterior
Mid-Tibia in Five Athletes. Tokai J Exp Clin
Med. 2007;32:121-125.
36. Warden SJ, Bennell KL, McMeeken JM, Wark
JD. Acceleration of fresh fracture repair using
the sonic accelerated fracture healing system
(SAFHS): a review. Calcif Tissue Int.
2000;66:157-163.
37. Yoshitaka H, Toshiharu S, Osamu U,
Toshifumi K, Kazuhisa B. Effect of low
internisty ultrasound on severe open
fractures. Seikei Geka (Orthopaedic Surgery
and Traumatology) (Japanese language).
2003;46(1):67-73.
38. Emami, A., Petren-Mallmin, M., Larsson, S.
No effect of low-intensity ultrasound on
healing time of intramedullary xed tibial
fractures. J Orthop Trauma. 1999;13:
252-257.
39. Rue, J.P., Armstrong, D.W., 3rd, Frassica,
F.J., Deafenbaugh, M., Wilckens, J.H. The
effect of pulsed ultrasound in the treatment
of tibial stress fractures. Orthopedics.
2004;27:1192-1195.
40. Gersten JW. Effect of metallic objects on
temperature rises produced in tissue by
ultrasound. Am J Phys Med. 1988;37:75-82.
41. Handolin L, Pohjonen T, Partio EK, Arnala I,
Tormala P, Rokkanen P. The effects of
low-intensity pulsed ultrasound in
bioabsorbable self-reinforced poly L-lactide
screw. Biomaterials. 2002;23:2733-2736.
42. Lehman J, et al. Ultrasonic effects as
demonstrated in live pigs with surgical
metallic implants. Arch Phys Med Rehabil.
1979;483-488.
43. Lotsova EI. Effect of ultrasound on the
strength of metal xing pins for fractures and
joint injuries. Mekh Kompoz Mat. 1979; No. 3,
548-549.
44. Premarket Approval P900009/Supplement 6,
Summary of safety and effectiveness data:
low-intensity pulsed ultrasound device for the
noninvasive treatment of nonunions.
45. Skoubo-Kristensen E, Sommer J. Ultrasound
inuence on internal xation with a rigid plate
in dogs. Arch Phys Med Rehabil. 1982;63,
371-373.
46. Pounder NM, Harrison AJ. Low intensity
pulsed ultrasound for fracture healing: A
review of the clinical evidence and the
associated biological mechanism of action.
Ultrasonics. 2008;48:330-338.
47. Siska PA, Gruen GS, Pape HC. External
adjuncts to enhance fracture heating: What
is the role of ultrasound? Injury-International
Journal of the Care of the Injured.
2008;39:1095-1105.
48. Rubin C, Bolander M, Ryaby JP, Hadjiargyrou
M. The use of low-intensity ultrasound to
accelerate the healing of fractures. J Bone
Joint Surg. 2001;83-A: No. 2, 259,270.
49. Ziskin MC. Report on the safety of the
Therasonics Medical Systems SAFHS
unit, model 2A. PMA900009, vol. 3,
section VI.A.1, 209-234.
Technical Information
EXOGEN Operating Specications
Ultrasound frequency 1.5 +/- 5% MHz
Modulating signal burst width 200+/- 10% microsecond (µs)
Repetition Rate 1.0+/- 10% kiloher tz(kHz)
Duty Factor 20%
Effective radiating area (ERA) 3.88 +/- 1% square cm (cm2)
Temporal average power 117 +/- 30% milliwatts(mW)
Spatial avg.-temporal avg. (SATA) 30+/- 30% mW/cm2
Beam non-uniformity ratio (BNR) 4.0 maximum
Battery 3.7 VDC, 700 mAh
Battery Type Lithium-ion
Input Voltage (USB) 5.0 VDC, 2.6A max.
Beam type Collimated
The essential performance of EXOGEN includes the following:
• Free from the display of incorrect numerical values (numbers) associated with the
ultrasound therapy
• Free from the production of unwanted ultrasound output
• Free from the production of excessive ultrasound output
• Free from the production of unintended or excessive transducer surface temperature
20 21Customer Service: Australia: 180 0 428 220 Ireland: 1800 552197 UK: 0800 0516384
EXOGEN Classications
EXOGEN has the following classications:
• Internally Powered Equipment
• Type BF Applied Par t
• EXOGEN device: IP-22 protection against ingress
of water
• Transducer: IP- 67 protection against ingress of dust
• Equipment not suitable for use in the presence of
a ammable anaesthetic mixture with air or with
oxygen or with nitrous oxide.
• Mode of operation – Intermittent
Guidance and Manufacturer’s
Declaration – Electromagnetic
Emissions and Immunity Testing
Electromagnetic
Compatibility Testing
Summary: Testing Report for:
Bioventus LLC.
Equipment Under Test: EXOGEN®
Used for Life Suppor t: No
Use in shielded enclosure: No
Guidance and manufacturer’s declaration – electromagnetic emissions
EXOGEN is intended for use in the electromagnetic environment specied below. The customer or the user of EXOGEN should
assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment – guidance
RF emissions
CI S P R 11
Group 1 EXOGEN uses RF energy only for its internal function. Therefore, its RF emissions
are ver y low and are not likely to cause any inter ference in nearby electronic equip-
ment.
RF emissions
CI S P R 11
Class B EXOGEN is suitable for use in all establishments other than domestic and those
directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations /
icker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
EXOGEN is intended for use in the electromagnetic environment specied below. The customer or the user of the EXOGEN should assure that it is used in such an environment.
Immunity test IEC 60601 Test Level Compliance Level Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000- 4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient/
burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
lines
±2 kV for power supply
lines
Not Applicable for input/
output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines IEC
61000-4-11
<5% UT
(>95% dip in UT) for 0,5
cycle; 40% UT(60% dip
in UT) for 5 cycles; 70%
UT(30% dip in UT) for 25
cycles; <5% UT(>95 %
dip in UT) for 5 sec
<5% UT
(>95% dip in UT) for 0,5
cycle; 40% UT(60% dip
in UT) for 5 cycles; 70%
UT(30% dip in UT) for 25
cycles; <5% UT(>95 %
dip in UT) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user of E XOGEN
requires continued operation during power mains interruptions, it is recommended that EXOGEN be pow-
ered from an uninterruptible power supply or a battery.
Power frequency (50/60
Hz) magnetic eld IEC
61000-4-8
3 A / m 3 A / m Power frequency magnetic elds should be at levels characteristic of a typical location in a typical com-
mercial or hospital environment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of
EXOGEN, including cables, than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter. Recommended separation distance:
d _ 1.2 √P
d _ 1.2 √P 80 MHz to 800 MHz
d _ 2.3 √P 800 MHz to 2,5 GHz
where Pis the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in meters (m). Field strengths from xed RF
transmitters, as determined by an electromagnetic site survey, ashould be less than the compliance level
in each frequency range. bInterference may occur in the vicinity of equipment marked with the following
symbol:
NOTE UTis the a.c. mains voltage prior to application of the test level.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should
be considered. If the measured eld strength in the location in which EXOGEN is used exceeds the applicable RF compliance level above, EXOGEN should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating EXOGEN.
bOver the frequency range 150 kHz to 80 MHz, eld strengths should be less than 1 V/m.
22 Customer Service: Australia: 180 0 428 220 Ireland: 1800 552197 UK: 0800 0516384 23
Customer Service
Customer Service is available to answer
questions regarding EXOGEN and to
handle servicing or disposal needs.
To contact the International Service Center:
Call toll free: Australia: 1800 428 220
Ireland: 1800 552197
UK: 0800 0516384
00800 02 04 06 08
Authorized European Community (EC)
Representative
EMERGO EUROPE
Molenstraat 15
2513 BH The Hague
The Netherlands
Tel: +31 (0) 70 345- 8570
Fax: +31 (0) 70 346-7299
Australian Sponsor:
Emergo Australia
Level 20, Tower II, Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
For additional information on the EXOGEN
Ultrasound Bone Healing System, please
visit our website at www.exogen.com.
Limited Warranty
Bioventus LLC (“Seller”) warrants to the
original purchaser (“Purchaser”) of its
EXOGEN Ultrasound Bone Healing System
(“System”) purchased by Purchaser directly
from Seller that the System conforms to
Seller’s manufacturing specications. This
warranty shall be in ef fect for a period of
one year from the date of purchase.
In the event of a material breach of this
warranty, upon timely written notice, Seller
will, at its sole option, either repair or
replace the System or refund the original
purchase price. This will constitute
Purchaser’s sole remedy. This limited
warranty does not extend to any re-sale or
other transfer of the System by Purchaser
to any other person or entity.
Seller expressly disclaims any and all other
warranties, either expressed or implied,
relating to the System or its performance,
including, without limitation, any IMPLIED
WARRANT Y OF MERCHANTABILITY and
any IMPLIED WARRANTY OF FITNESS
FOR A PARTICULAR PURPOSE.
Test Report # 100972305ATL-002, 02/07/2013. Testing performed by: Intertek, 1950 Evergreen Blvd, Suite 100, Duluth, GA 30096.
Recommended separation distances between portable and mobile
RF communications equipment and EXOGEN
EXOGEN is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of EXOGEN can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and EXOGEN as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum output power of
transmitter – watts (W)
Separation distance according to frequency of transmitter – meter (m)
150 kHz to 80 MHz
d = 1.2 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2,5 GHz
d = 2.3√P
0.01 0.12 0 .12 0.23
0.1 0.38 0.38 0.73
11.2 1. 2 2.30
10 3.79 3.79 7. 2 7
100 12.00 12.00 23.00
For transmitters rated at a maximum output power not listed above, the recommended separation distance din meters (m) can be estimated using the equation applicable to the frequency of
the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects and people.
CUSTOMER SERVICE
Authorized European Community (EC)
Representative
EMERGO EUROPE
Molenstraat 15
2513 BH The Hague
The Netherlands
Tel: +31 (0) 70 345-8570
Fax: +31 (0) 70 346-7299
Bioventus LLC
4721 Emperor Blvd Suite 100
Durham, NC 27703 USA
General Information: 1-800-396-4325
International Customer Service (toll free):
Australia: 1800 428 220
Ireland: 1800 552197
UK: 0800 0516384
00800 02 04 06 08
customercare-[email protected]
www.exogen.com
© 2014 Bioventus LLC All rights reserved
EXOGEN and the Bioventus logo are registered
trademarks of Bioventus LLC.
Product No. 81087028 Rev. A
2014-10
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