Bioventus EXOGEN User manual

EXOGEN®User Guide
Read before using your device
EXOGEN Overview
Getting Started
EXOGEN Setup
Tracking Your Treatment
EXOGEN Care
Troubleshooting
Customer Service

Caution
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.
EXOGEN is only intended for use by the individual for whom it is prescribed. EXOGEN is for single patient use ONLY.
THIS DEVICE IS NON-STERILE.
It does not require sterilization before use.
EXOGEN is a Class B digital apparatus which meets all requirements of the Canadian Interference-Causing Equipment Regulations.
EXOGEN est un appareil de classe B qui répond a toutes les exigences des Régulations Canadiennes sur les équipements pouvant
causer des interférences.
EXOGEN Label Symbol Descriptions and Equipment Classication
Information Symbol: refer to Instructions for Use.
Catalog Number
CE Mark: indicates conformity with European Council Directive of 14 June 1993 concerning Medical Devices
(93/42/EEC).
Type BF Applied Part. The transducer, shown in Figure 2 on page 2 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.

EXOGEN Overview 1
Indications for Use 1
EXOGEN Description 1
EXOGEN Device (EXOGEN) 2
Charger (power supply) 2
Strap 3
Ultrasound Gel 3
Important Things to Know 3
EXOGEN Usage 3
Contraindications 4
Warnings 4
Precautions 4
Display Symbols and Descriptions 5
Getting Started 7
Charging EXOGEN 7
Recharging EXOGEN 8
Preparing to Treat Your Fracture 9
Place the Strap 9
If You Have a Cast 10
Add Gel and Place Transducer 11
EXOGEN Setup 13
First Time Use 13
Time Setting 14
Treating Your Fracture
Start Treatment 15
EXOGEN Cleaning 16
Tracking Your Treatment 19
Track Usage 19
Treatment Calendar 19
Treatment Summary Data 19
Treatment History 20
Calendar Pause 21
EXOGEN Care 23
Operating Conditions 23
Storage 23
EXOGEN Expected Service Life 23
Battery and Charging Safety 24
EXOGEN Disposal 24
Removing the Battery for Disposal 25
Troubleshooting 27
Clinical Studies 28
Metal and Implants 28
Mechanism of Action 28
Adverse Events 28
Complications 28
References 29
Technical Information 30
EXOGEN Classications 31
Guidance and
Manufacturer’s Declaration 31
Customer Service 35
Limited Warranty 35
Table of Contents

EXOGEN OvErviEw

1
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. EXOGEN can
be used on both fresh fractures and non-
unions - and both can be conservatively
or surgically treated. EXOGEN transmits
a low-intensity ultrasound signal to the
fracture site through coupling gel, with little
or no sensation felt by the patient during
the treatment. Low-intensity pulsed ultra-
sound 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 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 specications 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
1-855-771-0606 to receive a replacement.
Figure 1: EXOGEN Ultrasound Bone Healing System
EXOGEN Device
Gel
Charger
Strap
EXOGEN OVERVIEW

2
EXOGEN Device (EXOGEN)
EXOGEN (Figure 2) features a transducer
at the end of a coiled cord, color screen,
power button and USB charging port. The
cord and transducer are not removable
from EXOGEN.
EXOGEN contains the internal electronics
and battery. It checks the ultrasound signal
to make sure EXOGEN works properly. The
transducer sends low-intensity pulsed ultra-
sound to the fracture site through the gel.
EXOGEN also can sense if gel is present
on the transducer surface.
EXOGEN stores and displays a calendar of
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 electri-
cal devices.
Charger (power supply)
EXOGEN is powered by a rechargeable
battery. A charger (Figure 3) is included
with EXOGEN. 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 US
120 VAC, 60 Hz, household electrical outlet.
Read more about how to charge EXOGEN
in “Getting Started” on page 7.
Figure 2 – EXOGEN Device (Part Number: 71034401)
Figure 3 – EXOGEN Charger (Part Number: 71034460)
USB charging
port
Color Screen
Button
Coiled cord
Transducer
Mini USB plug

3
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 Service at 1-855-771-0606
to nd out if there is another strap which
may t better.
Ultrasound Gel
Ultrasound gel (Figure 5) is provided for
use with EXOGEN. 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 alert from EXOGEN.
Only use the gel supplied. Do not use other
gels as they may damage the transducer
surface or block the signal. If you need
more gel, please call Customer Service
at 1-855-771-0606.
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.
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
at 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 used with one hand for
guiding and holding EXOGEN.
Read “Getting Started” (page 7) and
“Treating Your Fracture” (page 15)
before you begin using EXOGEN.
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
benet 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 185 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 1-855-771-0606 for instructions.
Figure 4 – EXOGEN Strap (Part Number: 71034622)
Figure 5 – Ultrasound Gel (Part Number: 71034694)
Port
Cap
Strap
Cap
Nozzle
Bottle
EXOGEN OVERVIEW

4
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 displace-
ment 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 insufciency
(poor blood supply), abnormal skin
sensitivity (very sensitive skin), sensory
paralysis (lack of sensation), alcoholism
and/or nutritional deciency
• Individuals receiving steroid, anti-
coagulant, prescription non-steroidal
anti-inammatory, 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
• The safety of EXOGEN when used
around acute elbow injuries has not
been established. A potential risk
exists for aggravation of heterotopic
bone formation.
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
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 radiofrequency energy
may cause interference. This interfer-
ence 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.
• For single patient use O NLY. The risk of
use between multiple patients includes
but is not limited to cross contamination
between patients as cleaning agents
and solvents are not recommended for
cleaning the transducer.
• 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 EXOGEN in
treating the fracture.

5
Display Symbols and Descriptions
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.
Calendar X-Mark A 20-minute treatment was not
completed on this calendar day.
Calendar Checkmark A 20-minute treatment was
completed on this calendar day.
Calendar Double
Checkmark*
Two-20 minute treatments were
completed on this calendar day.
Calendar Double
Checkmark Plus*
Three or more 20-minute
treatments were completed
on this calendar day.
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 count-
down timer reaches zero to show
that treatment is complete.
EXOGEN OVERVIEW
*EXOGEN should be used for only 20 minutes per day, or as prescribed by your doctor.

6
GettinG Started

7
EXOGEN has a rechargeable lithium-ion battery. A fully-charged battery delivers approximately ve 20-minute treatments.
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 below to charge EXOGEN:
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.
4. 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. (Figure 6)
5. When charging is complete, remove
the USB plug from EXOGEN, close
the USB cover and unplug the charger
from the wall.
USB Cover
(closed) USB Cover
(open)
Pull down at
tab to open
USB plug of charger
Charging symbol
Battery status
GETTING STARTED
Getting Started
Charging EXOGEN

8
Figure 6 – Battery Status Symbols
Battery Charge Levels
Full Charge
Partial Charge
Partial Charge
Low Charge
As you use EXOGEN, the symbol will
change to show the reduced battery level.
See Figure 6.
You may charge EXOGEN 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
at 1-855-771-0606. 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 7)
for instruction on charging EXOGEN.

9
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!
GETTING STARTED
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
Service at 1-855-771-0606.
Precaution: The transducer, strap and gel
are not sterile and placement on an open
wound is not advised.
If you have a cast, proceed to
“If You Have a Cast” (page 10).
Place the Strap
» Continue to “Add Gel and
Place Transducer”

10
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.
» Continue to “Add Gel and
Place Transducer”
If You Have a Cast

11
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 every time you treat your fracture.
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 trans-
ducer with the notch in the cap. Snap
the cap shut on the strap or the cast.
6. Replace the cap on the gel bottle.
» Continue to “First Time Use
or Treating Your Fracture”
GETTING STARTED
Add Gel and Place Transducer
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.

12
EXOGEN SETUP

13
Time 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 calendar screen. This indicates that
the time has been set on EXOGEN.
You do not need to set the minutes.
8AM 9AM 10 AM
www.exogen-intl.com
®8AM
10 AM
compliance
treatment days =
total days = %
®
S M T W T F S
treatment summary
100
0
0
August 2013
9 10
11
4
321
12 13 14 15
765 8
16 17
18 19 20 21 22 23 24
30 3125 26 27 28 29
First Time Use – EXOGEN Setup
EXOGEN has a calendar which tracks how often the system is used.
The current hour needs to be set to make sure the calendar is accurate.
The time must be set once, the very rst time EXOGEN is used to treat
your fracture.
Press button Start-up screen Time set
Flashing time set screen Press button once to
advance hour
Current hour Calendar
Press &
hold
» Time Setting continued
Next Page
EXOGEN SETUP
Press button once to
advance hour

14
Time Setting (cont)
4. The calendar appears on the screen
for 5 seconds. It shows the current
month and your treatment summary.
For more information on the calendar
screen, see “Tracking Your Treatment”
on page 19.
5. Next, the 20-minute countdown timer
appears on the screen. EXOGEN
automatically begins the ultrasound
treatment.
Note: The rst treatment needs to be com-
pleted in order for the time to remain set.
6. 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 27.
7. When the countdown timer reaches
zero, EXOGEN beeps and shows
the treatment complete checkmark
for 5 seconds. Then, EXOGEN beeps
and turns itself off.
Contact Customer Service at
1-855-771-0606 if you have
incorrectly set the time.
compliance
treatment days =
total days = %
®
S M T W T F S
treatment summary
100
0
0
August 2013
9 10
11
4
321
12 13 14 15
765 8
16 17
18 19 20 21 22 23 24
30 3125 26 27 28 29
Time Remaining
20:00
Time Remaining
20:00 Treatment Complete
20:00
Time Remaining
countdown timer
Calendar Treatment countdown
Treatment symbol
Battery statusCharging symbol
(shown only when charging)
Treatment countdown Completion

15
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 calendar appears on the screen for
5 seconds. It shows the current month
and your treatment summary. For more
information on the calendar screen,
see “Tracking Your Treatment” on
page 19.
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 27.
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.
www.exogen-intl.com
®
Time Remaining
20:00
Treatment Complete
compliance
treatment days =
total days = %
®
S M T W T F S
treatment summary
100
0
0
August 2013
9 10
11
4
321
12 13 14 15
765 8
16 17
18 19 20 21 22 23 24
30 3125 26 27 28 29
Press button Start-up screen
Calendar Treatment countdown
Completion
EXOGEN SETUP

16
EXOGEN Cleaning
After treatment is complete, you must clean
the transducer after each use.
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 serviced.
3. Wipe off 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.