Smith & Nephew EXOGEN 4000+ User manual

EXOGEN 4000+
™
Low-intensity Ultrasound Fracture Healing
System for the Treatment of Nonunion
and Fresh Fractures
*smith&nephew
Patient’s
Instructions
for Use
& Package
Insert
Caution: This device is intended for use only by
the individual for whom it is prescribed.

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NOTE: The EXOGEN 4000+™ device has been tested and
found to comply with the limits for Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against
interference with radio or television reception or
communication in home use of the device. The EXOGEN
4000+ device uses radio-frequency (RF) energy only for its
internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment. If abnormal operation of the
EXOGEN 4000+ device is observed, certain measures to
correct the problem may be necessary, like reorienting or
relocating the device.
If the EXOGEN 4000+ device causes interference to radio
or television reception, which can be determined by turn-
ing the EXOGEN 4000+ device off and on, the patient can
attempt to correct the interference by one or more of the
following measures:
•Reorient or relocate the radio or television receiver unit or
receiving antenna.
•Increase the distance between the device and the radio or
television receiver.
•Contact the Patient Services Department of Smith &
Nephew, Inc., if the above does not correct the problem.
This Class B digital apparatus meets all requirements
of the Canadian Interference-Causing Equipment
Regulations.
Cet appareil numérique de la classe B respecte
toutes les exigencies du Réglement sur le materiel
brouilleur du Canada.
Warning: Neither you or your physician can se-
lect or change any of the EXOGEN 4000+ ultra-
sound signal specifications. No attempt should
be made to modify or repair the EXOGEN 4000+
device.
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DEFINITION OF SYMBOLS
Attention, consult manual.
Refer to Instructions for Use
A blinking addition (+) symbol with an audio tone means you need to add gel to the transducer face.
Pulsing Treating Symbol indicates device is operating properly
Treatment Stop or Treatment Lockout Symbol
Type B APPLIED PART
CE Mark indicates conformity with European Council Directive of
14 June 1993 concerning Medical Devices (93/42/EEC).
EU: Not for General Waste
The wheelie bin symbol denotes that this device should not be disposed of with ordinary household waste at the
end of it's life. For details of how to dispose of this item correctly, please contact your local government waste
disposal agency or contact your local Smith & Nephew representative.
Manufacturer
Authorized Representative in the European Community
Serial Number (First four digits of serial number indicate month and year of manufacture)
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. The device is only intended for use by the individual for whom it is prescribed.
SN

Table of Contents
A. Introduction .........................................................................1
B. Indications for use...............................................................1
C. Contraindications, General Warnings, and
Precautions .........................................................................2
D. Device Description..............................................................4
1. The EXOGEN 4000+™ Bone Healing System ......................4
2. Technical Specifications of the EXOGEN 4000+
Ultrasound Signal .................................................................5
3. The EXOGEN 4000+ System Components .........................5
a. The Main Operating Unit (MOU) .....................................5
b. The Transducer................................................................6
c. Snap-on Cap with Tether ................................................6
In-Cast Application
d. Retaining and Alignment Fixture (RAF) ............................7
e. Black Round Foam Disc ...................................................7
f. Round Felt Plug/with Tab .................................................7
On-Cast or Non-Cast Application
g. RAF/Snap-on Cap/Strap Assembly.................................7
h. Foam Pad .........................................................................7
Other Accessories
i. Coupling Gel....................................................................8
E. Adverse Effects ...................................................................8
F. Device Operating Instructions............................................9
1. Starting your Daily Treatment Period .....................................9
2. Turning “On” the EXOGEN Model 4000+ for a Daily
Treatment Period .................................................................11
3. At the End of a Daily Treatment Period...............................12
G. Interruption of a Treatment Period....................................12
H. Special Instructions when No Cast Is Used or when the
Cast Is Removed and Treatment Is Continued..................13
1. Without Cast Treatment.......................................................13
a. Starting Your Treatment Period ......................................13
b. At the End of a Without Cast Treatment Period.............15
I. Treatment Schedule...........................................................16
J. Trouble Signals and Corrective Actions ............................16
1. Add Gel ...............................................................................17
2. Error or Problem Message...................................................17
K. Care and Handling of the EXOGEN 4000+ System ..........18
L. Return Shipping Instructions.............................................19
M.General Information...........................................................19
N. Guidance and Manufacturer’s Declaration —
Electromagnetic Emissions and Immunity Testing ...........20
Appendix 1: Clinical Study Results for the Nonunion
Supplement Completed Cases—Stratification by
Categorical Variables.........................................................22
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A. Introduction
Your physician has prescribed a device, the EXOGEN
4000+™ Bone Healing System, which may heal your
nonunion or accelerate the healing of your fracture. This
device utilizes pulsed, low-intensity ultrasound, which has
been shown to heal non-unions and to speed up fracture
healing. You are an active participant with the physician
during this course of therapy.
Questions regarding your fracture should be referred to
your physician.
Please call the Patient Service Department of Smith &
Nephew, Inc., regarding any problem with the EXOGEN
4000+ device that cannot be resolved after consulting this
manual. The Patient Service Department may be reached at:
In the United States, call [phone], select option 2;
In Europe, call ([phone]; and
In Other Countries, call (USA) ([phone]
The EXOGEN 4000+ device is provided to you for the
treatment of your fracture upon the prescription of your
physician.
PLEASE BE SURE TO READ THE ENTIRE MANUAL
BEFORE USING THE EXOGEN 4000+ DEVICE.
B. Indications for Use
The EXOGEN 4000+, or any other EXOGEN Bone Healing
System is indicated for the non-invasive treatment of
established nonunions†excluding skull and vertebra. In
addition, they are indicated for accelerating the time to a
healed fracture, for fresh, closed, posteriorly displaced
distal radius (Colles’) 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 nonunion is considered to be established when the
fracture site shows no visibly progressive signs of healing.
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C. Contraindications, General Warnings
and Precautions
Contraindications:
There are no known contraindications to the use of
this device.
Nonunion Indication:
Warnings:
The safety and effectiveness of the use of this device has
not been established in nonunions for the following:
•nonunions of the vertebra and the skull.
•individuals lacking skeletal maturity.
Precautions:
•The safety and effectiveness of the use of this device in
pregnant or nursing women has not been established.
•Careful consideration of the use of this device must be
decided on an individual basis in the presence of
malaligned nonunion since the device will not correct or
alter displacement, angulation or other malalignment.
•Cell phones may cause interference and patients should
avoid cell phone use during treatments.
• With active, implantable devices, such as cardiac
pacemakers, operation may be adversely affected by close
exposure to the EXOGEN™ device; therefore, evaluation
during EXOGEN treatment by the attending cardiologist or
physician is recommended.
•Patients in the clinical studies were instructed to apply the
device for one treatment period of 20 minutes each day.
The safety and effectiveness of the EXOGEN device when
used for more than one daily 20-minute treatment period
is unknown.
•The age ranges of the patients in the PMA nonunion
studies were 17–86. The effect of EXOGEN therapy on
patients outside this age range is unknown.
Complications:
No device-related adverse reactions or medical
complications related to the use of this device were
reported during the clinical studies. Two patients in a post-
market registry reported mild skin irritation caused by skin
sensitivity to the coupling gel. Both were resolved by a
change of coupling medium to mineral oil or glycerin.

Fresh fracture indication:
Warnings:
The safety and effectiveness of the use of this device has
not been established for the following:
•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).
•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).
•Fractures that are open Grade II or III (fractures with large
wounds) or that require surgical intervention or with
internal or external fixation (screws and/or plates used to
hold your broken bone in place) or that are not sufficiently
stable for the closed reduction (manipulation of the fracture
without surgery) and cast immobilization (cast treatment).
•Individuals lacking skeletal maturity (generally below 18
years of age although one patient in the tibia study was 17
years of age) or who are pregnant/nursing women.
•Pathological fractures due to bone pathology or malignancy
(fractures due to disease).
•Individuals with thrombophlebitis (blood clot in a vein),
vascular insufficiency (poor blood supply), abnormal skin
sensitivity (very sensitive skin), sensory paralysis (lack of
sensation), alcoholism and/or nutritional deficiency.
•Individuals receiving steroid, anti-coagulant, prescription
non-steroidal anti-inflammatory, calcium channel blocker
and/or diphosphonate therapy. Individuals using these
therapies were excluded from the studies because of the
possible effects of these therapies on bone metabolism.
Precautions:
•Animal studies conducted to date do not suggest any long
term adverse effects from the use of this device. Clinical
studies conducted for the EXOGEN™ PMA with long term
patient follow up for up to 78 months do not suggest any
long term adverse side effects from the use of this device.
However, possible longer-term adverse effects in humans
are unknown.
•The EXOGEN device will not correct or affect the post-
reduction (when your fracture is initially set and placed in a
cast) condition of your fracture such as displacement of the
bone ends at your fracture or improper alignment of your
fractured bone.
•The age ranges of the patients in the fresh fracture PMA
study were 17–67 years of age (54% were 31 years of age
or older) in the tibia study and 20–78 (74% were 50 years
of age or older) in the Colles’ study. The effect of EXOGEN
therapy on patients outside this age range is unknown.
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•Operation of implantable devices, such as cardiac
pacemakers, may be adversely affected by close exposure
to the EXOGEN™ device. This applies to you or any other
person in close proximity during treatment. You or the
other person should be evaluated by the attending
cardiologist or physician before starting treatment with the
EXOGEN device.
•Cell phones may cause interference and patients should
avoid cell phone use during treatments.
•The clinical studies for the EXOGEN PMA required only one
daily treatment period of 20 minutes. Although the
EXOGEN device can be used more than once per day, the
effects of multiple daily treatments are unknown; therefore,
it is important that you use the device as instructed by
your physician.
Complications:
No device-related adverse reactions or medical
complications related to the use of this device were
reported during the tibia or distal radius studies. In the
distal radius study, one patient complained of pain during
treatment but this resolved by the next follow up visit and
one patient, complaining of pain, withdrew from the study.
D. Device Description
1. The EXOGEN 4000+ Bone Healing System
The EXOGEN 4000+ device provides a non-invasive
therapy for the healing of nonunion or the acceleration
of fresh fracture healing that you administer at home for
20 minutes daily, or as prescribed by your physician,
until your physician determines your fracture to be
sufficiently healed to discontinue device use. The device
transmits a low intensity ultrasound signal to the fracture
site through coupling gel. Ultrasound is high frequency
sonic pressure waves. The device provides low intensity
ultrasound of 30 mW/cm2, which is comparable to the
diagnostic ultrasound intensities used in sonogram (fetal
monitoring) procedures, and is 1% to 5% of the
intensities used in conventional therapeutic ultrasound.
Due to the very low intensity of the ultrasound, you will
feel little or no sensation during the treatment. Design
features alert you in case of improper application or
performance of the device.

2. Technical Specifications of the EXOGEN 4000+™
Ultrasound Signal
Ultrasound frequency ............1.5 ± 5% megahertz (MHz)
Modulating signal burst width....200±10% microsecond (μs)
Repetition rate ............................1.0 ± 10% kilohertz (kHz)
Effective radiating area...........3.88 ± 1% square cm (cm2)
Temporal average power..........117 ± 30% milliwatts (mW)
Temporal maximum power.....625 ± 30% milliwatts (mW)
Peak power ............................................1.25 ± 30% watts
Spatial avg.–temporal avg. (SATA) .......30± 30% mW/cm2
Spatial avg.–temporal maximum (SATM)..161±30% mW/cm2
Beam non-uniformity ratio (BNR) .................4.0 maximum
The device uses a non-electrical, plastic locating
component, the Retaining and Alignment Fixture (RAF).
When incorporated into a strap, the RAF is used for a
Non-Cast application or for an On-Cast application. The
RAF is also available for incorporation into a cast for In-
Cast applications. The RAF Cap Assembly is snapped
on the RAF after the insertion of the transducer during
treatment periods. In both On-Cast and Non-Cast
applications, the RAF/strap is applied to the cast or skin
over the fracture site and insures proper positioning
during the 20-minute treatment period. During non-
treatment periods in both the In-Cast and On-Cast
applications, the transducer is removed and replaced
with a felt plug to maintain even pressure on the skin.
The RAF Cap is replaced on the RAF during non-
treatment periods.
Neither you nor your physician can select or change any
of the EXOGEN 4000+ ultrasound signal specifications.
3. The EXOGEN 4000+ System Components
The EXOGEN 4000+ device is composed of a Main
Operating Unit (MOU) Assembly with a permanently
attached transducer, and accessory items, which are
shown below in (Figure 1).
a. The Main Operating Unit (MOU): The Main
Operating Unit (MOU) is powered by a non-
replaceable and non-rechargeable lithium battery
pack with a life of a minimum of 150 treatment
periods of 20 minutes each. Since the range of the
number of total treatment sessions for some patients
may exceed this number, your device may require a
battery change (see Section J). The MOU is
connected to the transducer by a permanently
attached coiled inter-connecting cable.
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The MOU:
•monitors and controls system operation during treatment.
•verifies operation of the transducer and the MOU and
monitors the MOU battery for a low battery condition.
•controls the duration of the 20-minute treatment period.
•monitors for the presence/absence of coupling gel on
the transducer surface. The MOU then alerts you
with a visual and an audible beeping sound if gel is
not present on the transducer.
•automatically shuts off the device at the end of the
20-minute treatment period, and alerts you with an
audio signal that treatment has ended.
•maintains a complete record of your daily use of the
device.
•monitors compliance with prescribed treatment
usage.
b. The Transducer: The transducer is powered by the
MOU battery supply and is connected to the MOU by
a permanently attached flexible coil cable capable of
extending from 1.5 feet (45 cm) to approximately 5
feet (1.5 m). The round, flat, black transducer surface
attached to the coil cable transmits the low intensity
ultrasound signal to the skin at the fracture site
through a layer of ultrasound coupling gel. Coupling
gel is necessary, as air will not transmit ultrasound.
c. Snap-on Cap with Tether: For In-Cast, On-Cast,
and Non-Cast applications, the snap-on cap with a
tethering ring is used to hold the transducer in place
within the RAF. The snap-on cap has a spring
attached to its inner side that keeps a light pressure
on the transducer, thereby ensuring contact of the
transducer surface with the skin. The tethering ring
attached to the cap is placed around the RAF
opening and prevents the possible loss of the
snap-on cap.
Figure 1
a.
b.
i.
c.
g.

In-Cast Application
d. Retaining and Alignment Fixture (RAF): If you are in
a cast, the RAF is incorporated into the cast (In-Cast
installation—see Figure 2).The RAF holds the
transducer in the proper position during the daily
20-minute treatment period.
e. Black Round Foam Disc: A black round foam disc is
available for placement on top of the transducer to
ensure contact of the transducer surface with the
skin when the cast thickness is excessive. Your
installer will advise you if you should use this
accessory during treatment periods.
f. Round Felt Plug/With Tab: The round felt plug with
tab is placed into the center hole of the RAF between
treatment periods. The felt plug should be inserted
with the tab on top. The tab will assist you in
removing the pad. The felt plug maintains even
pressure on the skin to prevent “window edema”
(swelling). The spring force in the cap assembly will
hold the felt plug in place against the skin.
On-Cast or Non-Cast Application
g. RAF/Snap-on Cap/Strap Assembly: The strap
assembly is used for an On-Cast or Non-Cast
application and contains the RAF, with the snap-on
cap tethered to the RAF. The snap-on cap has a
spring attached to its inner side which keeps a light
pressure force on the transducer, thereby ensuring
contact of the transducer surface with the skin.
Note: In an On-Cast application, do not loosen the
strap after installation, as it should remain securely in
place until you are healed. The RAF holds the
transducer in the proper position during the daily 20
minute treatment period.
h. Foam Pad: A foam pad is supplied with a self-
adhesive backing on one surface. The foam pad is
used to provide a soft-surface padding under the RAF
for contact with the skin in a Non-Cast application.
Figure 2
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Other Accessories
i. Coupling Gel: Two containers of hypoallergenic
ultrasound coupling gel, which is 96% water, are
provided with your EXOGEN™ device. You must apply
coupling gel to the transducer surface at the start of
each treatment period in order to permit transmission
of the ultrasound signal from the transducer surface
to the skin over the fracture site. Each container has
200ml of coupling gel. A single pump (1.4cc) portion
is the recommended amount of coupling gel for each
treatment session. Each bottle will provide enough gel
for approximately 140 treatments. Please replace the
clear plastic top on the gel bottle after dispensing gel.
There are other coupling mediums which can be
used if a skin reaction is noted with the standard gel.
Please call the Patient Service Department of Smith &
Nephew, Inc., if this occurs.
Note: EXOGEN ultrasound coupling gel supplied is
the recommended gel for use with this system. Do
not substitute other gels as they may damage the
transducer surface or impede signal transmission.
Please call the Patient Service Department of Smith &
Nephew, Inc., if you need more coupling gel.
Manuals: This manual describing how to use the
EXOGEN 4000+ System is included.
E. Adverse Effects
In laboratory, animal and clinical research, the EXOGEN
device intensity (power level) (See Section D — “Device
Description”) was assessed for its potential for producing
significant temperature increases in body tissue, the most
common and best understood effect of conventional
ultrasound. Conventional therapeutic ultrasound
applications utilize ultrasound intensities of approximately
1,000 to 5,000 mW/cm2, and must be applied in a stroking
manner to avoid tissue necrosis caused by excessive
temperature increases due to stationary application. The
30 mW/cm2output intensity of the device you received is
typically only 1% to 5% of the output intensity of
conventional therapeutic ultrasound devices and therefore
can be used in a stationary application. The ultrasound
intensity is comparable to diagnostic ultrasound (1 to 50
mW/cm2), such as the intensities used in obstetrical
sonogram procedures (fetal monitoring). The results of the
PMA safety report on the EXOGEN device and EXOGEN
PMA research indicate that the EXOGEN device is
incapable of producing harmful temperature increases in
body tissue and there is also no evidence of non-thermal
adverse effects.

F. Device Operating Instructions
1. Starting Your Daily Treatment Period
The instructions shown below are to be followed when
using the EXOGEN 4000+™ device with an ON-cast or IN-
cast application. See Section H for instructions on device
use when your physician does not use a cast or
continues EXOGEN 4000+ treatment after cast removal
or uses a removable cast or splint. Your physician or the
cast technician will prepare your cast and install the
Retaining and Alignment Fixture (RAF) Strap Assembly on
your cast or incorporate the separate RAF in the cast at
the fracture location (see Section D—”Device
Description”). The instructions shown below are to be
followed when using the device:
a. Remove the RAF Cap (Figure 3) by gently squeezing
the tabs on the Cap Assembly with an inward motion
and lift it off of the RAF.
b. Remove the round felt plug from the RAF opening. The
cap tethered to the strap assembly prevents
inadvertent dropping or loss.
c. Prepare the transducer (Figure 4) by placing one pump
of coupling gel on the round flat black surface of the
Figure 4
Figure 3
Ê
Ê
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transducer. Do not spread the gel over the transducer
surface. Replace the plastic top on the gel bottle.
Note: The system is designed so that the gel
spreads evenly when the transducer contacts the
skin. You should use the recommended amount of
gel. The EXOGEN 4000+™ device will alert you if
insufficient gel is present (see Section J —“Trouble
Signals and Corrective Actions”).
d. Insert the transducer, with gel applied, into the RAF
opening (Figure 5a). Align the transducer cable with
the cap slot before snapping the cap in place
(Figures 5b, 5c).
Figure 5b
Figure 5a
Figure 5c

2. Turning “On” the EXOGEN Model 4000+™ for a
Daily Treatment
Press and release the orange “On/Off” button once on
the Main Operating Unit (MOU) (see Figure 6) to turn ON
the system. When the “On/Off” button is pressed to turn
ON the system the following processes occur:
a. The system will emit a 2-tone beep and run its built-
in testing circuit that checks the unit operation. This
self-test takes approximately 2 seconds during which
the display will show all icons.
b. The device will then display the total number of FULL
treatments completed.
c. The device will then display the total number of
PARTIAL treatments.
d. The device will then start treatment. The Pulsing
Treatment Symbol and the countdown clock will be
shown on the display (see Figure 6a).
The LCD display will provide a warning message if either
insufficient gel has been applied or a fault or problem
has been detected. After the 20-minute treatment period,
the unit will emit a two-tone beep and turn itself off.
The EXOGEN 4000+ device is intended for one
20-minute treatment period per day. It is recommended
that there be at least 12 hours between treatments
although this spacing may not always be possible to
maintain. As an example, if the treatment started at
10:00 PM on Monday, Tuesday’s treatment should be
performed after 10:00 AM. In any case, you should
always follow the treatment schedule as prescribed
your physician. Note: Each time the device is turned
on and used for at least 3 minutes, a record of the
use will be stored in the device.
Figure 6 — Push ON/OFF Button
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3. At the End of A Daily Treatment Period:
The device will automatically stop treatment after 20
minutes. A two-tone beeping sound will indicate that
treatment has been completed, and the LCD and system
will then turn OFF automatically.
a. Remove the transducer from the RAF. The transducer
must be removed from the RAF after each treatment
session.
b. Using a soft cloth, tissue, paper towel or a cotton
swab, gently clean the skin area at the treatment
site to remove the coupling gel (Figure 7). Clean
the inside surface of the RAF and remove any gel
that may have accumulated on the transducer to
prevent gel hardening on the device.
c. Replace the round felt plug with tab, into the RAF
(Figure 8).
d. Snap on the RAF cap by positioning it over the RAF
hole and pushing down until it snaps securely in place.
G.Interruption of a Treatment Period
It is recommended that each treatment period be a continuous,
uninterrupted 20-minute period. During a treatment period,
if for any reason you must attend to something for a short
Figure 7
Pulsing Treating Symbol indi-
cates device is operating
properly.
Treatment countdown will
continue as long as proper
treatment is occurring.
Countdown will pause if gel
error occurs.
Figure 6a

period of time (e.g., to answer a telephone or a doorbell),
the device can be carried with you. In this instance, it is
not necessary to turn off the device. However, if you do not
want to carry the device to attend to the interruption, you
will have 30 seconds before the device shuts off, and you
will need to begin another complete 20-minute treatment.
Within 30 seconds, complete the following:
1. Open the RAF cap and remove the transducer from
the RAF.
2. Attend to the reason for the interruption of treatment.
3. Reapply coupling gel to the transducer, as necessary.
4. Replace the transducer in the RAF.
5. Snap the RAF cap back on.
6. If your total response time for the above steps took
less than 30 seconds, the treatment will continue to
completion. However, if the total time of response
exceeds 30 seconds, the device will turn off. It will be
necessary to follow steps 1–5 above before pressing
the “On” button to start a complete, new 20-minute
treatment period.
H. Special Instructions when No Cast Is
Used or when the Cast Is Removed
and Treatment Is Continued
1. Without-Cast Treatment:
a. Starting Your Treatment Period: Your physician will
place a mark over the fracture site or indicate an area
on the skin as a landmark to ensure proper
placement of the device for each treatment (Figure 9).
1. Included with this device is a RAF Strap Assembly
(Figure 1) used for “on cast” as well as “without
cast” treatment.
2. A foam pad is included with the device to provide
Figure 8
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a padded surface during “without-cast” treatment.
The foam pad has a paper covered adhesive side
with a tab for easy removal. The paper backing
should be removed and the adhesive side of the
foam placed on the underside of the RAF (Figures
10a, 10b) to provide a padded surface over the
fracture site and to prevent movement of the RAF
on the skin surface.
3. For your daily treatment with the EXOGEN 4000+™
device use the RAF with the attached foam pad and
strap to secure the RAF over the fracture site. Ensure the
circular opening in the RAF is centered over the
treatment area as indicated by your physician (Figure 11).
Figure 10b
Figure 10a
Figure 9