Bioventus EXOGEN User manual

EXOGEN®User Guide
Read before using your device
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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 Label Symbol Descriptions and Equipment Classication
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 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.
Caution symbol: Indicates the need for the user to consult the instructions for use for important cautionary information.
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EXOGEN Overview 1
Indications for Use 1
EXOGEN Description 1
EXOGEN Device (EXOGEN) 2
Charger (power supply) 2
Strap 2
Ultrasound Gel 3
Important Things to Know 3
EXOGEN Usage 3
Contraindications 3
Warnings 3
Precautions 4
Display Symbols and Descriptions 4
Getting Started 5
Charging EXOGEN 5
Recharging EXOGEN 6
Preparing to Treat Your Fracture 7
Place the Strap 7
If You Have a Cast 8
Add Gel and Place Transducer 8
First Use – EXOGEN Setup 9
First Use 9
Hour Setting 9
Treating Your Fracture 10
Start Treatment 10
EXOGEN Cleaning 11
Tracking Your Treatment 13
Track Usage 13
Treatment Calendar 13
Treatment Summary Data 14
Treatment History 15
Calendar Pause 16
EXOGEN Care 17
Operating Conditions 17
Storage 17
EXOGEN Expected Service Life 17
Battery and Charging Safety 18
EXOGEN Disposal 19
Removing the Battery for Disposal 19
Troubleshooting 20
Clinical Studies 21
Adverse Events 24
Complications 24
References 26
Technical Information 27
EXOGEN Classications 28
Guidance and
Manufacturer’s Declaration 29
Customer Service 32
Limited Warranty 32
Table of Contents
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1
Figure 1: EXOGEN Ultrasound Bone Healing System
EXOGEN Overview
Indications for Use
The EXOGEN Ultrasound Bone Healing System
is indicated for:
• The non-invasive treatment of established
non-unions†excluding skull and vertebra.
• The EXOGEN device has also been reported
as effective as an adjunctive non-invasive
treatment of established non-unions in patients:
- With internal or external fracture xation
hardware present. EXOGEN cannot penetrate
metal and therefore should not be applied
directly over hardware.
- Undergoing treatment for infection at the
fracture site. EXOGEN is not intended to
treat the infection.
- Believed to have diminished bone quality.
EXOGEN is not intended to treat diminished
bone quality.
• Accelerating the time to a healed fracture for fresh,
closed, posteriorly displaced distal radius fractures
(fractures of the end of the large bone in your
forearm) and fresh, closed or Grade I open tibial
diaphysis fractures (fractures in the middle 80%
of the large bone in your lower leg) in skeletally
mature individuals when these fractures are
orthopaedically managed by closed reduction
and cast immobilization (adult individuals eighteen
years of age or older who have fractures, with or
without minor skin wounds, that are placed in a
cast for treatment).
†
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 is designed both for
use with conservatively-treated fresh fractures
and non-unions, or surgically-treated non-unions.
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
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 auto-
matically alerts the patient in case of improper
application or performance. The EXOGEN
Ultrasound Bone Healing System consists of
one EXOGEN device, a charger, a gel bottle
and strap. The EXOGEN device provides the
treatment control circuitry, the battery supply
and monitors the operation of the transducer
at the fracture site. The signal 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 1-800-836-4080 to
receive a replacement.
EXOGEN Device
Gel
Charger
Strap
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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 ultrasound to the
fracture site through the gel. EXOGEN can also
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 electrical 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 radio
frequency emissions or decreased electromag-
netic 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 5.
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 1-800-836-4080 to nd out
if there is another strap which may t better.
EXOGEN OVERVIEW
Figure 2 – EXOGEN Device (Part Number: 71034401)
Figure 3 – EXOGEN Charger (Part Number: 71034460)
Figure 4 – EXOGEN Strap (Part Number: 71034622)
USB charging
port
Color Screen
Button
Coiled cord
Transducer
Mini USB plug
Port
Cap
Strap
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Ultrasound Gel
Ultrasound gel (Figure 5) is provided for use with
EXOGEN. The gel is to be placed on the trans-
ducer 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 1-800-836-4080.
The expiration date for the ultrasound gel is
located on the side of the gel bottle.
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 5) and “Treating
Your Fracture” (page 10) 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 343 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
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 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, anticoagulant,
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
• 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
xation (screws and/or plates used to hold your
broken bones in place) or that are not sufciently
stable for closed reduction (manipulation of the
fracture without surgery) and cast immobilization
(cast treatment)
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
Figure 5 – Ultrasound Gel (Part Number: 71034694)
Cap
Nozzle
Bottle
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• 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.
• Placement of the transducer directly over internal
xation may result in the treatment signal being
partially or fully blocked and may reduce the
effectiveness of EXOGEN in treating the fracture.
• When choosing a treatment site, the transducer
shall be positioned such that the ultrasound beam
is not impeded by any internal xation which is
directly in line with the fracture site (e.g., not
directly over metal plating). This may require
placement of the transducer on the opposite side
of the limb or perpendicular to the fracture line.
Correct placement should be conrmed using
radiographic and/or anatomical markers by a
healthcare provider during the tting of the device.
The site of application should be marked onto the
patient’s skin with an indelible marker to guide
repeatable placement.
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 should be used for only 20 minutes per day, or as prescribed by your doctor.
EXOGEN OVERVIEW
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5
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 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
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6
GETTING STARTED
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 1-800-836-4080. 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 “Charging EXOGEN” (page 5) for
instruction on charging EXOGEN.
Figure 6 – Battery Status Symbols
Battery Charge Levels
Full Charge
Partial Charge
Partial Charge
Low Charge
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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 1-800-836-4080.
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 8).
Place the Strap
» Continue to “Add Gel and
Place Transducer”
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!
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If You Have a Cast
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.
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 open-
ing.
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 trans-
ducer. 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.
» Continue to “First Use”
or “Start Treatment”
GETTING STARTED
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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 conrmation 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 automatically
turn off.
EXOGEN Setup
First Use
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 hour must be set once, the very rst time EXOGEN is turned on.
8AM 9AM 10 AM
www.exogen.com
®
8AM
10 AM 10 AM
Hour Set
Press button Start-up screen Hour set
Flashing hour set screen Press button once to
advance hour
Current hour
Press &
hold
Contact Customer Service at
1-800-836-4080 if you have
incorrectly set the hour and
would like to reset it.
Note: EXOGEN will effectively
deliver treatment even if the
correct hour is not selected.
Press button once to
advance hour
Conrmation screen
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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 13.
3. Next, the 20-minute countdown timer
appears on the screen. EXOGEN auto-
matically 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 20.
4. When the countdown timer reaches zero,
EXOGEN beeps and shows the treatment
complete checkmark. The treatment
complete checkmark displays for
5 seconds. Then, the device will
automatically turn off.
Warning: Use of this equipment adjacent to or
stacked with other equipment should be avoided
because it could result in improper operation. If
such use is necessary, this equipment and the
other equipment should be observed to verify
that they are operating normally.
Contact Customer Service at
1-800-836-4080 if you have
incorrectly set the hour and
would like to reset it.
Note: EXOGEN will effectively
deliver treatment even if the
correct hour is not selected.
www.exogen.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
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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.
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12
If You Have a Cast
Follow steps 1-3 (previous page), and then do the
following instead of step 4:
4. Carefully clean any gel from your cast, skin
and port with a soft cloth.
5. Insert 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.
EXOGEN SETUP
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13
Tracking Your Treatment
Track Usage
EXOGEN tracks how often you use it. A calendar
shows your usage on the screen. There are two
parts to the calendar screen. The top part shows
a calendar month and the bottom part shows the
treatment summary information. See Figure 7.
Figure 7 – Treatment Calendar
Treatment Calendar
The current month is shown when you turn on EXOGEN for a treatment. Today’s date will have a purple
box around it. EXOGEN will mark your calendar every day with one of the following symbols: X-mark,
checkmark, double checkmark*, or double checkmark plus.*
X-mark You did not complete a 20 minute 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
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
Calendar
data
Summary
data
*EXOGEN should be used for only 20 minutes per day, or as prescribed by your doctor.
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14
Treatment Summary Data
The treatment summary shows your overall use
of EXOGEN. The summary data always accounts
for all your days of treatment, not just the current
month.
Treatment days are the number of days that you
have completed a 20-minute treatment. This
includes days marked with a checkmark, double
checkmark, or double checkmark plus.
Total days are the number of days passed since
your rst treatment.
The large compliance % is the number of treat-
ment days divided by the number of total days.
For example, if you use EXOGEN every day for
60 days, you will have the following numbers:
Treatment days= 60
Total days= 60
Compliance= 100%
If you have EXOGEN for 60 days, but forgot to
treat 10 of those days, your numbers will look like:
Treatment days= 50
Total days= 60
Compliance= 83%
REMEMBER!Use EXOGEN every day for 20
minutes, or as directed by your doctor.
compliance
treatment days =
total days = %
®
treatment summary
100
60
60
23 24
30 31
25 26 27 28 29
compliance
treatment days =
total days = %
®
treatment summary
83
50
60
23 24
30 31
25 26 27 28 29
TRACKING YOUR TREATMENTS
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15
Treatment History
After using EXOGEN over time, you may want
to view your treatment history month by month.
EXOGEN will store up to twelve months of recent
treatment history. You can show your treatment
history to your doctor. EXOGEN lets you view
your treatment history without having to start 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.
2. Press and hold the power button until the
Treatment History screen appears.
3. Then, a calendar of the current month of
treatment appears for 5 seconds.
4. EXOGEN then shows the previous month
of treatment for 5 seconds. EXOGEN will
display up to 12 months of previous
treatment history. This continues until
your most recent twelve months of
treatment have been shown. Please
note, if you have treated with EXOGEN
for fewer than 12 months, the EXOGEN
device will only display treatment history
for the number of months you have used
your device. This could be as few as one
or two months. You may exit the Treatment
History mode at any time by pressing
and holding the button until EXOGEN
turns itself off.
5. After the last month displays for
5 seconds, EXOGEN turns itself off.
compliance
treatment days =
total days = %
®
S M T W T F S
treatment summary
100
88
88
August 2013
9 10 11
432
1
12 13 14 15
765 8
16 17 18 19 20 21 22
23 24 25 28 29 30 31
compliance
treatment days =
total days = %
®
S M T W T F S
treatment summary
100
88
88
July 2013
9 10 11
432
1
12 13 14 15
765 8
16 17 18 19 20 21 22
23 24
compliance
treatment days =
total days = %
®
S M T W T F S
treatment summary
100
88
88
June 2013
9 10 11
432
1
12 13 14 15
765 8
16 17 18 19 20 21 22
23 24
30
25 26 27 28 29
Treatment
History
®
History start screen Calendar 1
Calendar 2 Calendar 3
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16
Calendar Pause
You can pause the calendar screen to
view your treatment history for longer
than 5 seconds.
Any calendar screen can be paused. To pause
the calendar, perform the following steps:
1. When you see a calendar screen, press the
button to pause.
2. The calendar will pause, a pause symbol
appears, and the word “PAUSED” ashes.
3. Press the button again to un-pause the
calendar and continue.
4. The calendar screen will automatically
un-pause after 2 minutes and continue.
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
TRACKING YOUR TREATMENTS
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17
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 modify, 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 EXOGEN not to work properly
• If any parts of EXOGEN or its accessories are
damaged, do not use EXOGEN. Please contact
Customer Service at 1-800-836-4080 to return
your EXOGEN for servicing
• EXOGEN is classied as an IP-22 device. The
IP-22 classication 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 classied as an IP-67
component. The IP-67 classication indicates that
the transducer is:
- Dust-tight
- Will not be damaged by water under dened
conditions of pressure and time (up to 1 meter
underwater)
• 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
portable 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 of 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 85%
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 temperature
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 temperatures
or the internal electronic components may be
damaged
• As with any home electronic device, protect
EXOGEN from impact, exposure to moisture,
liquid spills, sand, dirt 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.
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