Orthofix AccelStim 4300 User manual

Instruction Manual
Model 4300
AccelStim
™
Bone Healing Therapy

Symbol Meaning
REF
ISO 15223-1
5.1.6 Catalogue number: This symbol specifies the catalogue number so that
the medical device can be identified.
SN
ISO 15223-1
5.1.7 Serial number: This symbol specifies the medical device serial number.
Read Instructions for Use
IEC 60601-1
ISO 7010-M002 Read instructions for use: Failure to read the instructions may result in
a hazard.
IEC 60417
5333 Type BF applied part: Applied part (ultrasound transducer) isolated from
the rest of the appliance with a specific degree of protection against
electrical hazards, specifically regards admissible leakage current.
1ISO 15223-1
5.4.12 Single patient multiple use: Indicates a medical device that may be used
multiple times (multiple procedures) on a single patient
IEC 60417
5172 Class II equipment: Appliance in which protection against electric shock
does not rely on basic insulation only, but includes additional safety
precautions such as double insulation.
ISO 15223-1
5.1.1 Manufacturer: Name and address of the manufacturer.
ISO 15223-1
5.1.3 Date of Manufacture
Directive
2012/19/EU Not for general waste: This symbol indicates that the AccelStim device
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 sales
representative.
10˚C
40˚C
ISO 15223-1
5.3.7 Temperature limits
700 hPa
1060 hPa
ISO 15223-1
5.3.9 Atmospheric pressure limitation
30%
75% ISO 15223-1
5.3.8 Humidity limitation
IP22
ISO 15223-1
5.3.4 Keep dry
IP22: Degrees of protection provided by enclosures, see page 24.
ONLY 21 CFR 801.109 Prescription only
MR
ASTM F2503 MR Unsafe: Device must not be subjected to MRI scans.
ISO 15223-1
5.1.4 Use-by Date
ISO 15223-1
5.2.7 Non Sterile
E522288
MEDICAL-ULTRASOUND EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARD ONLY IN ACCORDANCE WITH
ANSI/AAMI ES60601-12005 + AMD 1 2012
CAN/CSA-C22.2 N0.60601-1:14

Table of Contents
Prescription Information ....................................................................................................................3
• Indications For Use.....................................................................................................................3
• Contraindications ........................................................................................................................3
Device Description................................................................................................................................3
• Device Components ...................................................................................................................4
• Device Life and Usage ...............................................................................................................7
• Warnings.........................................................................................................................................7
• Precautions....................................................................................................................................8
• Adverse Effects............................................................................................................................9
Device Operation................................................................................................................................10
• Performing a Treatment ........................................................................................................10
• Care and Cleaning After Treatment Completed............................................................12
• Tracking Your Treatment........................................................................................................13
• How to Export Your Treatment History Data ................................................................15
• Device Use and Care ...............................................................................................................15
• Battery and Charging Safety................................................................................................16
• Recharging the AccelStim Device Battery......................................................................17
• Travel.............................................................................................................................................18
• Recycle or Disposal of Your Device After Use...............................................................18
Service....................................................................................................................................................18
Warranty................................................................................................................................................19
Troubleshooting the AccelStim Device.......................................................................................20
• Visual and Audio Battery Indicators..................................................................................20
• Interrupted Treatment Indicators.......................................................................................21
Storage and Operating Environments .......................................................................................23
The AccelStim Device Classifications .........................................................................................23
General Information..........................................................................................................................24
Operating Specifications .................................................................................................................24
Compliance Statments.....................................................................................................................25
Clinical Studies ....................................................................................................................................29
References............................................................................................................................................37
Device Box Components
1 - AccelStim Device
1 - Literature Pack
1 - Ultrasound Transducer
1 - Elastic Strap with Transducer Holder
1 - Power Supply
1 - Ultrasound Gel
Orthofix Patient Services: 800-535-4492 or 214-937-2718
To learn more about Orthofix, please visit our website at www.orthofix.com.

3 4
PRESCRIPTION INFORMATION
Indications for Use
The AccelStim™ device is indicated for the noninvasive treatment of established nonunions
excluding skull and vertebra, and for accelerating the time to a healed fracture for fresh,
closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open
tibial diaphysis fractures in skeletally mature adult individuals when these fractures are
orthopedically managed by closed reduction and cast immobilization.
Contraindications
There are no known contraindications for the AccelStim device.
DEVICE DESCRIPTION
The AccelStim device is a medical device that applies ultrasound to the treated area to
accelerate the osteogenic process, thereby reducing healing times. The AccelStim device
generates a low-intensity pulsed ultrasound (LIPUS) signal as a prescribed, nonsurgical
treatment for nonunion fractures or fresh fractures (closed, posteriorly displaced distal
radius fractures, or closed or Grade I open tibial diaphysis fractures). The ultrasound signal
is an acoustic vibration with frequency above the human auditory level, thus the device
is silent. To learn more about bone growth stimulation, please visit our patient website at
BoneGrowthTherapy.com.
The device is lightweight, adjustable and portable. Treatment application is simple and
does not require any assistance by specialized medical staff as the patient can apply it on
their own. Everything needed for the treatment of your fracture is included in each device
box (Figure1: The AccelStim device box contents).
Figure 1: The AccelStim device box contents
Transducer
Power Supply
(Charger)
Ultrasound Gel
Transducer
Holder
Strap
Generator

3 4
Device Components
Generator (See Figure 3)
The generator is equipped with:
• A liquid crystal display (LCD) and audible indicators provide important feedback
during treatment.
1. The battery charge status
2. The daily treatment timer
3. The lowest part of the screen will display all symbols related to the execution
of the treatment and error messages
• Three buttons
4. Function button to start or pause the treatment
5. ON/OFF button, marked with symbol
6. RESET button
• On the lower side of the device, there are three sockets:
7. The USB port marked with symbol
8. The charging port marked with symbol
9. The transducer port marked with symbol
Model 4300
Ultrasound Gel
Power Supply
Strap
Transducer Holder
On/Off Button
Function Button
Transducer
USB Port
Charging Port
Transducer Cord
Transducer Port
Display
Figure 2: AccelStim device components

5 6
78
9
5
1
23
4
6
Figure 3 : The AccelStim device Generator

5 6
Ultrasound Transducer
Figure 4 : Transducer and Transducer Cord
The transducer (with the writing upward facing) should be placed inside the transducer
holder which is connected to the strap (as seen in Figure 5). The transducer holder
must be placed directly over the treatment area.
Figure 5 : Transducer inside the Transducer Holder
Ultrasound Gel
The supplied ultrasound gel is provided for use with the AccelStim device. Gel is
necessary to allow the ultrasound signal to reach your fracture through the skin. The
gel must be applied to the transducer, side with no writing, before starting a treatment.
Apply a thick layer (1-2mm) of gel to the transducer as the AccelStim device will not
work properly if the gel is not covering the transducer. If you need more gel, please
contact Patient Services at 1-800-535-4492.
NOTE: Some patients may experience mild 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.

7 8
Power Supply (Charger)
The AccelStim device is powered by a rechargeable lithium-ion battery pack. The
battery pack may provide up to five 20-minute treatments when fully charged.
An external power supply to charge the battery is provided with the device. Use only
the Orthofix provided power supply to charge the battery. Read more about charging
the device in the Battery and Charging Safety section.
Figure 6 : Power Supply (Charger)
Device Life and Usage
The AccelStim device should be worn for 20 minutes each day (as prescribed by your
physician) and it’s recommended to treat at the same time each day. Your physician
will determine the overall length of treatment (months/weeks) on an individual basis
according to fracture healing progress. The AccelStim device provides daily treatments
for up to 365 days.
The expiration date for the device can be found on the external packaging label. This
device should only be used by one patient before disposal. For instructions on how to
dispose of this device, see the Recycle or Disposal of Your Device after Use section in
the manual on page 18.
Warnings
The safety and effectiveness of the use of this device has not been established for:
• Fractures with post-reduction displacement of more than 50% (i.e., fractures in
which the opposing broken bone ends are out of alignment by more than one half
of the width of the bone).
• Pathological fractures due to bone pathology or malignancy (fractures due to
disease).
• Pregnant or nursing women.
• Individuals with thrombophlebitis (blood clot in a vein), vascular insufficiency (poor
blood supply), abnormal skin sensitivity (very sensitive skin), sensory paralysis
(lack of sensation), alcoholism and/or nutritional deficiency.
• Individuals receiving steroid, anticoagulant, and prescription nonsteroidal anti-
inflammatory medications

7 8
• 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.
• Nonunions 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 lower leg).
• Fresh fractures that are open Grade II or III (fractures with large wounds), or that
require surgical intervention with internal or external fixation (screws and/or
plates used to hold your broken bones in place), or that are not sufficiently stable
for closed reduction and cast immobilization (manipulation of the fracture without
surgery).
• Clinical studies leveraged to support the safety and effectiveness of the AccelStim
device may not necessarily be applicable to patients of all races and ethnicities.
Such demographic details were not provided in the referenced clinical studies.
• The AccelStim device is MR Unsafe. The device presents a projectile hazard in this
environment.
• The device should not be used over skin that is infected or is not intact, if
scarring or blood is evident at the application point, or in the presence of other
local substances or abnormal tissues that may affect the acoustic signal such
as inflammation (rash), hematoma, or abscess. The impact of such soft tissue
abnormalities within the effective radiating area of the transducer has not been
studied by any manufacturer.
Precautions
• The AccelStim device 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 the AccelStim device. The physician
should advise the patient, or other person in close proximity during treatment, to
be evaluated by their attending cardiologist or implant physician before starting
treatment with the AccelStim device.
• The cords pose a risk for strangulation. Keep out of reach of children.
• Cell phones, televisions, and other devices using radio frequency identification
(RFID) readers, electronic security systems (e.g., metal detectors, electronic article
surveillance), near-field communications (NFC) systems, wireless power transfer
and unique medical emitters such as electrocautery, electrosurgical units, and
diathermy equipment may cause interference. Don’t use the AccelStim device
closer than 30 cm (12 inches) from these electromagnetic (EM) emitters.
• The safety and effectiveness of the AccelStim device for use of more than one
daily 20-minute treatment period has not been studied.
• When choosing a treatment site, ensure that the site selected allows for full

9 10
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 the AccelStim device in treating the fracture.
• Only the region of the fracture within the effective radiating area (3.5 cm2) of the
transducer is likely to benefit from the AccelStim device’s treatment. Therefore,
the physician and patient should take care in appropriately placing of the device
over the fracture site.
• Placement of the transducer directly over internal fixation may result in the
treatment signal being partially or fully blocked and may reduce the effectiveness
of the AccelStim device 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 fixation which is directly in
line with the fracture site (i.e., 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 confirmed using radiographic and/
or anatomical markers by a health care provider during the fitting of the device.
The AccelStim device’s site of application should be marked onto the patient’s skin
with an indelible marker to guide future transducer placements.
Adverse Events
Unlike conventional (physical therapy) ultrasound devices, the AccelStim device is
incapable of producing harmful temperature increases in body tissue.26 The output
intensity of the device is 30mW/cm2 and 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). While no device-related adverse reactions
or medical complications were reported in the referenced clinical studies (see “Clinical
Studies” section in this manual), there are several potential adverse events associated
with the use of this device. In case you experience any pain, discomfort or other
unwanted effects related to the use of the device, stop using the device and contact
Patient Services and/or your physician.

9 10
DEVICE OPERATION
The AccelStim device can be powered in two modes:
• Using internal battery mode. When the internal battery is fully charged, the
AccelStim device can deliver up to five treatments.
• Using the external power supply, the unit is powered while recharging the
internal battery.
NOTE: The battery must be fully charged before using the device for the first time.
Performing a Treatment
Step-by-step instructions for device application can be found in the table below.
To Apply
The AccelStim device, gel, transducer, transducer holder, and strap will be needed to
treat your fracture. The strap is not needed if you are in a cast for your fracture. If your
physician has placed an ‘X’ on the fracture site this is the spot that the transducer
holder and transducer will need to be placed directly over.
Check the transducer and the transducer cord before starting treatment. If there are
any signs of damage (cracks, etc.) do not use the AccelStim device and contact Patient
Services at 1-800-535-4492.
PRECAUTION: This AccelStim device is nonsterile and does not require sterilization
before use. Placement on an open wound is not advised.
1. Connect the transducer to the AccelStim device by inserting the transducer
cord into the transducer port. Keep the white dot on the connector
over-mold facing upwards.
2. Open the blue cover of the transducer holder by rotating it
counterclockwise.
3. Place the transducer holder over the area that will receive treatment and
secure with the Velcro attached to the elastic strap. The strap should be
snug, comfortable, and against the skin to prevent motion or slippage. Do
not overtighten the strap. Excess strap can be cut if needed to adjust
the transducer holder over the fracture site.
4. Apply the gel to the side of the transducer with no writing to form a 1-2
mm thick layer. Use a finger to spread the gel on the transducer to obtain
an even layer.

11 12
Starting a Treatment
1. Turn on the device by pressing the on/off button for two seconds. Once
you hear a beep, release the button, and the display screen will light up.
Ver 1.0
2. The Orthofix logo will appear on the display screen as the device
powers on.
3. The device will display 20 minutes of treatment time along with a play
symbol to specify that the device is now ready for treatment. The gel
symbol will flash for 10 seconds to remind the user to apply the
ultrasound gel on the transducer before starting treatment.
19:48
4. To start the treatment, press the function button on the front panel of
the device. The AccelStim device signals the start of treatment with a
beep. During treatment, the display shows the remaining therapy time.
NOTE: The AccelStim device will power down automatically after two
minutes of inactivity, to reduce battery consumption.
5. To pause the device in the middle of a treatment, press the
function button and the treatment will stop. The display will
show a pause symbol with the remaining treatment time
stopped. To resume treatment, press the function button again
6. Once the treatment screen reaches zero, the display screen will
show a checkmark to specify treatment completed and
emit three beeps. After 30 seconds, the AccelStim device will
automatically turn off.
5. Insert the transducer inside the transducer holder so that the serial
number is visible.
6. Close the blue cover by rotating it clockwise.

11 12
Care and Cleaning After Treatment Completed
The AccelStim device should be used following good hygiene practices and cleaned
regularly. Avoid hair, dust, and exposure to direct sunlight. Before cleaning the
AccelStim device, make sure that it is switched off and disconnected from the
power supply. To avoid potential damage, handle the transducer carefully using the
instructions below, and do not drop it. Clean the device thoroughly to help ensure
effective treatment.
Clean the device after each treatment as indicated below:
CAUTION:
• Never use any spray products directly on the AccelStim device to avoid the risk
of liquid penetration.
• Never pour water or liquids of any type onto the AccelStim device.
• The elastic strap is a washable fabric like ordinary clothing.
1. Turn off the AccelStim device by press and hold down the On/Off button
until hear a short beep.
2. Open the blue cover of the transducer holder by rotating it counterclockwise.
3. Gently remove the transducer from the transducer holder.
4. Gently clean the transducer with a slightly damp cloth using water or a
neutral detergent (such as household liquid dishwashing detergent).
5. Clean off any ultrasound gel from the transducer holder, strap or your skin.

13 14
Tracking Your Treatment
The AccelStim device tracks your overall compliance to the treatments performed
for up to 365 days. Up to 104 recent treatment sessions are visible on the AccelStim
device while in Calendar Mode. Both the treatment day and the duration of the
treatment are recorded and displayed as follows:
• Day/Date on black background, no treatment performed.
• Day/Date on yellow background, less than 20 minutes treatment performed.
• Day/Date on green background, 20 minutes treatment performed.
• Day/Date on green background and along with a + symbol, more than one
20 minute treatment performed.
NOTE: The AccelStim device will display compliance data for up to 104 treatment
records. The complete record is available by download via USB – reference under
section “How to Export Your Treatment History Data.”
To Enter Calendar Mode
To view your treatment summary history perform the following steps to enter
calendar mode:
2 3 4 5 6 7 8
9 10 11 12 13 14 15
16 17 18 19 20 21 22
23 24
30 31
25 26 27 28 29
1
M T W T F S S
+
June 2022
1. To enter calendar mode the AccelStim device should be off or while
device is charging.
2. Press and hold the On/Off button for at least 5 seconds until you
hear a long beep.
2 3 4 5 6 7 8
9 10 11 12 13 14 15
16 17 18 19 20 21 22
23 24
30 31
25 26 27 28 29
1
M T W T F S S
+
June 2022
3. The display screen will show the first treatment calendar month that
compliance data was recorded.
4. In the upper right corner, there will be an image of three small dots.
The three small dots are displayed to indicate that the other months
of treatment history will be shown on the display screen.

13 14
2 3 4 5 6 7 8
9 10 11 12 13 14 15
16 17 18 19 20 21 22
23 24
30 31
25 26 27 28 29
1
M T W T F S S
July 2022
5. After 5 seconds, the display screen will automatically switch calendar
months to show the treatment history captured the following month.
4 5 6 7 8 9 10
11 12 13 14 15 16 17
18 19 20 21 22 23 24
25 26
30 31
27 28 29 30 31
321
M T W T F S S
August 2022
6. The sequence will stop once the last calendar month of treatment
history was recorded. In the upper right corner, a stop symbol will
display. Pressing the function button again, will restart the treatment
summary history from the beginning.
7. To exit calendar mode, and turn off the AccelStim device, press and
hold the on/off button until you hear a short beep.
Pausing Your Treatment Summary History
1. Press the function button to pause the sequence of treatment
history from month to month. Pausing the sequence allows you to
view your treatment history longer than 5 seconds.
2 3 4 5 6 7 8
9 10 11 12 13 14 15
16 17 18 19 20 21 22
23 24
30 31
25 26 27 28 29
1
M T W T F S S
July 2022
2. Pressing the function button to pause the sequence will display a
pause symbol in the upper right corner. Pressing the function button
again will restart the sequence.

15 16
How to Export Your Treatment History Data
To export your treatment history you will need a portable USB storage device. In order
to do this, please use the following steps:
The AccelStim device stores the overall treatment record and up to 104 detailed
treatment records which include the treatment day and duration of the treatment.
Detailed treatment data (day and duration of treatment) prior to the identified 104
treatment records is not accessible once the day has passed. If you want this type of
data for the entire life of the device, it is recommended that you export your treatment
history approximately every 3 months.
NOTE: In the event the function button is pressed and restarts the treatment
summary history sequence while the portable USB storage device is still connected to
the AccelStim device, the treatment data file will be overwritten.
2 3 4 5 6 7 8
9 10 11 12 13 14 15
16 17 18 19 20 21 22
23 24
30 31
25 26 27 28 29
1
M T W T F S S
July 2022
1. Insert a portable USB storage into the USB port.
2. Turn on the AccelStim device in calendar mode, as specified in
“To Enter Calendar Mode”.
3. The USB symbol appears on the bottom right corner along with
an arrow symbol indicating data has been saved on the
portable USB storage device, in the file labeled “AccelStimTrtLog_
nnnnnnnnn.txt”, where “nnnnnnnnn” is the serial number of the
device. If the file already exists on the portable USB storage device,
data will be overwritten.
4 5 6 7 8 9 10
11 12 13 14 15 16 17
18 19 20 21 22 23 24
25 26
30 31
27 28 29 30 31
321
M T W T F S S
August 2022
4. After five seconds, the next month is displayed and data is appended
to the same file on the portable storage device; this step is repeated
for each displayed month.
5. Data saving ends when the display shows the last month of the
registered treatments and the check symbol is shown next to
the symbol.
6. Remove the portable USB storage device and analyze the data with
a PC. In the case of Excel, please use the function “import data from
the file.”
If the portable USB storage device is not removed
and the AccelStim device is turned on in treatment
mode, the connection of the portable USB storage
device is indicated by the symbol next to the battery
symbol. When the portable USB storage device is
removed from the AccelStim device, the symbol
disappears.

15 16
Device Use and Care
The AccelStim device should be handled with care. Follow these instructions to ensure
optimal and safe operation of the device.
• The AccelStim device is for single patient use.
• Inspect the device prior to each use for wear, deterioration or damage.
• The use of accessories other than those specified and provided may result in
increased emissions or decreased immunity of the device.
• Dropping or mishandling the AccelStim device may damage the device and it
may stop working.
• The patient is the intended operator of this device; for safety purposes all
instructions should be followed when using the AccelStim device.
• Use of the AccelStim device in any manner other than intended could have
harmful effects and/or void the warranty.
• If any parts of the AccelStim device or accessories are damaged, do not use the
AccelStim device. Please contact Patient Services at 1-800-535-4492.
• Do not attempt to modify, disassemble or repair the AccelStim device. There are
no user serviceable parts inside.
• Check the integrity of the transducer before each treatment session. If it is
damaged, contact Patient Services at 1-800-535-4492 for a replacement.
• Do not expose the AccelStim device or its lithium-ion battery to heat sources or
throw into a fire due to risk of malfunction or explosion.
• Do not use the device or its applied parts (transducer) near breathing systems or
other devices that use concentrated oxygen.
• Do not handle any of the system components with wet hands, especially when
connecting the power supply.
• Do not dip or splash any of the system’s components with water or any other
type of liquid. In the event of the accidental immersion of the AccelStim device in
liquids, it must no longer be used. Contact Patient Services at 1-800-535-4492
if any of these occur.
• The AccelStim device is designed to alert the user of any problems by means of
visual and audio messages. When possible, restore the normal condition and
restart the treatment as described within the Troubleshooting the AccelStim
device section of this user manual on page 20.
• Do not connect any part of the unit to other equipment or devices.
• Do not connect the AccelStim device to any part not intended for use and not
supplied by the manufacturer.
• Attention: connecting cables could cause a strangulation hazard if incorrectly used.
• Do not put any part of the medical device into mouth in order to avoid risk of
suffocation.
• Do not cover the device during charging or use.
• Avoid placing the control unit against the skin/body while charging the battery
as the unit may become hot.
• The user must never make any repairs on the system.
• In case of failure, the user should contact Patient Services at 1-800-535-4492.
• Device Interference: Electromagnetic interference, such as active cellular phones,
radio-frequency identification (RFID) readers, electronic security systems (e.g.,
metal detectors, electronic article surveillance), near-field communications
(NFC) systems, wireless power transfer and unique medical emitters such as
electrocautery, electrosurgical units, and diathermy equipment can interfere

17 18
with the normal AccelStim device operation. To restore normal operation, press
the reset button on the left side of the AccelStim device with a pointed object,
and turn on the device. Be sure to remove the source of disturbance before
continuing the treatment if closer than 30 cm (12 inches).
Battery and Charging Safety
To ensure that the device is functioning properly, the AccelStim device constantly
monitors battery voltage level in treatment mode and displays on the upper right
corner of the screen. When the battery level decreases to low battery level, the plug
symbol and the battery level shown in red indicate the need to connect the external
power supply to recharge the battery. In the low battery condition, treatment delivery
can continue.
If not recharged, the battery level decreases to an empty battery level, indicated by a
flashing empty battery symbol and three repeated short beeps. The AccelStim device
will automatically stop treatment. To continue treatment, connect the power supply
and press the function button.
Recharging the AccelStim device Battery
To recharge the battery within the AccelStim device, use the following steps:
1. Open the charging port cover on the generator.
2. Plug the power supply DC plug into the charging port located on the
generator.
3. Plug the power supply into an AC wall outlet.
4. When the power is connected, the generator emits a short “beep” and
the battery charging process started. During the recharging battery
process, the battery charge status indicator moves from one level to
the next until process is finished. Please refer to Visual and Audio Battery
Indicators on page 20 for more information.
5. When the charging process is completed the full battery symbol is
displayed on the screen. Remove the power supply and insert the rubber
piece back into the charging port.
NOTE: When the power supply is connected to the AccelStim device while the device is
in treatment mode, the charging process starts and a flash symbol appears next to the
battery status symbol.
WARNING: In case of a faulty power supply, the device is not powered on or charging is
not started, contact Patient Services at 1-800-535-4492 for assistance.

17 18
Travel
Check with your airline regarding recommendations for packing and traveling with the
AccelStim device. The device contains rechargeable lithium ion batteries that are not
serviceable or removable.
Recycle or Disposal of Your Device After Use
The AccelStim device and all its parts cannot be disposed of as urban waste but
are subject to separate collection according to the procedures established by local
authorities.
To help reduce waste from going to the landfill, Orthofix is happy to help you recycle
your AccelStim device after your treatment is complete and your physician has advised
you to discontinue use.
Please visit BoneGrowthTherapy.com/Recycle
or contact Patient Care Services at 1-800- 535-
4492 for further information on our free recycling
program. We’ll provide you with a pre-paid return
mailing label so that your device can be recycled.
If you choose not to recycle your AccelStim
device, you may dispose of the device according
to your local governing guidelines (ordinances).
We strongly encourage you to take advantage
of our free recycling program, so we can work
together and limit waste. Let’s make a difference
together!
The AccelStim device is a US Class III medical device (prescription only) that cannot be
sanitized or used by another person.
Dispose of the device properly to prevent injury.
DO NOT dispose of the AccelStim device in an incinerator.
This device contains lithium batteries.
SERVICE
If you have questions concerning the device or require any assistance, please call
Patient Services at 1-800-535-4492 (U.S. only). There are no user serviceable parts.
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19 20
WARRANTY
Orthofix US LLC (“Orthofix”) warrants the AccelStim device to be free from defects in
materials and workmanship for one year from the date of first use. Provided that all
terms and conditions of this Limited Warranty are complied with, Orthofix will replace
defective components.
This Limited Warranty applies to the product only under normal use and does not
cover any damage or defect caused by accident, misuse, abuse, fire, flood, and acts of
God, or by any alteration, tampering, repair, or attempted repair by anyone other than
Orthofix. This warranty only applies to the patient for whom the product is prescribed
and is not assignable or transferable.
Defective products covered by this Limited Warranty must be returned to Orthofix,
Attention: Orthofix Returns. You must call a Patient Services representative at 1-800-
535-4492 or your local distributor to obtain the return authorization number and
address prior to returning the product.
Except as specifically required by applicable law, the foregoing warranty is in lieu
of all other warranties, expressed or implied. Orthofix specifically disclaims any
and all warranties of merchantability or fitness for a particular purpose. Under no
circumstances shall Orthofix, its authorized representative, affiliated, or subsidiary
companies be liable for special, consequential, or incidental damages. The sole remedy
with respect to any defective product shall be limited to replacement.
This Limited Warranty may not be extended or modified except in writing by Orthofix.
No sales person, representative, distributor or physician is authorized to make or
consent to any extension or modification of the terms of this Limited Warranty.
For additional information and/or device assistance, contact Orthofix Patient Services
at 1-800-535-4492.