Orthofix AccelStim 4300 User manual

Instruction Manual
Model 4300
AccelStim
™
Bone Healing Therapy

EQUIPMENT CLASSIFICATION AND DEVICE SYMBOL
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 30.
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
E522288
N/A UL Listing: Medical ultrasound equipment as to electrical shock, fire
and mechanical hazard only in accordance with “ANSI/AAMI ES60601-
1(2005) s+ AMD 1 (2012)” “CAN/CSA-C22.2 N0.60601-1:14”
ISO 15223-1
5.2.7
Non Sterile

AccelStim Device Instruction Manual
Table of Contents
Prescription Information ....................................................................................................................3
• Indications For Use.....................................................................................................................3
• Contraindications ........................................................................................................................3
• Warnings.........................................................................................................................................3
• Precautions....................................................................................................................................4
• Adverse Effects............................................................................................................................4
AccelStim Device Description...........................................................................................................5
• How the AccelStim Device Works.........................................................................................6
• AccelStim Device Life.................................................................................................................6
AccelStim Device Operation..............................................................................................................7
• Quick Operation ...........................................................................................................................9
• Treatment Instructions..............................................................................................................9
• Charging the Battery..................................................................................................................9
• Follow These Steps to Charge the Battery ....................................................................10
• Visual and Audio Indicators..................................................................................................11
Device Application..............................................................................................................................14
Patient Adherence .............................................................................................................................16
Device Use and Care .........................................................................................................................18
Storage and Operating Environments .......................................................................................21
Service....................................................................................................................................................22
Clinical Studies and Information...................................................................................................23
AccelStim Device Classifications..................................................................................................30
General Information..........................................................................................................................30
Operating Specifications .................................................................................................................31
Compliance Statements ..................................................................................................................32
Warranty................................................................................................................................................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
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.
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.
• 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),

4
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 15 cm (6 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 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 your patient receives is 30mW/cm2and is typically only 1% to 5%
of the output intensity of conventional therapeutic ultrasound devices. The ultrasound

5
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 nonthermal 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.
DEVICE DESCRIPTION
The AccelStim device generates a low-intensity pulsed ultrasound (LIPUS) signal as a
nonsurgical, prescription treatment for fracture nonunions or fresh fractures (closed,
posteriorly displaced distal radius fractures, or closed or Grade I open tibial diaphysis
fractures). The device is lightweight, adjustable and portable, including a rechargeable
battery that allows freedom of movement during treatment. A liquid crystal display
(LCD) and audible indicators provide important feedback during treatment. See “Device
Operation” for more information.
On/Off Button
Function Button
Transducer
Charging Port
Transducer Cord
Transducer Port
Display
Model 4300

6
Ultrasound Gel
Power Supply
Strap
Transducer Holder
How the AccelStim Device Works
The AccelStim device is a medical device that applies ultrasound to the treated area to
accelerate the osteogenic process, thereby reducing healing times. The application of
this ultrasound transducer is simple and does not require any assistance by specialized
medical staff, as the patient can apply it on their own. To learn more about bone
growth stimulation, please visit our patient website at BoneGrowthTherapy.com.
Device Life
The AccelStim device provides daily treatments for up to 365 days. The physician
determines the overall length of treatment (months/weeks) on an individual basis
according to fracture healing progress. 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 on page 22 of this manual.

7
DEVICE OPERATION
5
1
2
3
4
6
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
4. Function button to start or pause the treatment
5. ON/OFF button, marked with symbol
6. RESET button

8
78
9
7. The USB port marked with the symbol
8. The charging port marked with the symbol
9. The transducer port marked with the symbol

9
Quick Start Instructions
1. Connect the transducer to the AccelStim device by inserting the transducer cord into the
transducer port.
2. Wear the strap such that the transducer will be on the area to be treated and secure it
with the Velcro attached to the elastic strap.
3. Open the blue cover of the transducer holder by rotating it counterclockwise.
4. Apply the gel to the side of the transducer with no writing to form a 1-2 mm thick layer.
5. Insert the transducer inside the transducer holder so that the serial number is visible
and then close the blue cover by rotating it.
6. Turn on the device by pressing On/Off Button for two seconds, until you hear a “beep”.
7. To start the treatment, press the Function Button of the device on the front panel.
8. Wear the device over treatment site for 20 minutes every day or as prescribed by your
physician.
9. To recharge the battery, open the charging port cover, plug the power supply into the
charging port, then plug the power supply into an outlet.
AccelStim Usage
• The AccelStim device should be worn for 20 minutes each day as prescribed by
the physician.
• The AccelStim device should be worn at the same time each day that is most
convenient for the patient’s schedule.
• The overall treatment duration (months/weeks) will vary based on the specific
patient conditions as determined by their physician.
Charging the Battery
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.
The AccelStim device is powered by a rechargeable lithium-ion battery pack. The
battery pack will provide up to five treatments when fully charged. A power supply to
charge the battery is provided with the device. Use only the Orthofix provided power
supply to charge the battery.
To ensure that the device is functioning properly, the AccelStim device constantly
monitors battery voltage and the electrical signal. The LCD will display a battery
capacity symbol as the battery decreases or increases. The red indicator and the plug
symbol will 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.

10
Follow these steps to recharge the battery
1. Open the charging port cover.
2. Plug the power supply into the charging port located on the AccelStim device.
3. Plug the power supply into an outlet.
4. Please refer to Visual and Audio Battery Indicators. When the power is connected, the
battery charging process starts and a flash symbol appears on the battery
status symbol.
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.
During the battery charging process, the battery charge status indicator moves from
one level to the next until the process is finished. Please refer to Visual and Audio
Battery Indicators
WARNING: In case of a faulty power supply, the flash symbol does not appear.
Contact Patient Services for assistance.
1
2

11
Visual and Audio Battery Indicators
Battery charge status is shown on the upper right corner of the display.
When the battery is fully charged, the AccelStim device can deliver up to
five treatments. Once powered on, the AccelStim device will wait to start
treatment. The AccelStim device will power down automatically after two
minutes of inactivity, to reduce battery consumption.
The battery symbol is characterized by several notches, which decrease
as the battery runs down.
The battery level will decrease gradually until it reaches the low battery
level. The red indicator and the plug symbol will display indicating the
need to connect the power supply to recharge the battery.
When the battery level is low, connect to the power supply using the
instructions on page 10.
When the power supply is connected to the AccelStim device, the
charging process starts and a flash symbol appears next to the battery
status symbol. Warning: In case of a faulty power supply, the flash
symbol does not appear. Contact Patient Services for assistance.
During the battery charging process, the battery charge status indicator
moves from one level to the next until the process is finished. When the
charging process is completed the full battery symbol is displayed. It is
possible to recharge the battery when the AccelStim device is turned
off. Disconnect the power supply and insert the rubber piece into the
charging port.
If a faulty battery is detected when the device is turned on and the
charging process is not possible, a battery symbol with the warning
symbol (triangle/exclamation point) will appear on the screen. Please
contact Patient Services for assistance.
In case of faulty battery, it is possible to complete a treatment by
connecting the external power supply to the AccelStim device. After a
few seconds, the AccelStim device will automatically start in treatment
mode. At the end of the treatment, it is necessary to disconnect the
power supply from the AccelStim device to power down the device.
In case of faulty battery, it is not possible to switch the AccelStim device
to calendar mode. Battery charge status is shown on the upper right
corner of the display. The X symbol on the battery indicates that the
battery is faulty and is not charging.

12
Interrupted Treatment Indicators
• If the device is not used for long periods, the internal battery may be completely
discharged. It is recommended to recharge the battery before starting the
treatment.
• If the battery does not allow treatment completion, fully recharge the battery. If the
problem persists, contact Patient Services for assistance.
• For a better battery efficiency, always charge the battery in environments with
temperatures below 35°C/95°F.
If treatment is interrupted, the user is notified of the problem by means of visual and
audio messages. When possible, restore the normal condition and restart the treat-
ment by pressing the function button. If further assistance is needed, please contact
Patient Services at 1-800-535-4492.
Display Message Audio Signals Problem and Solution
Three short
beeps every 3
seconds.
Transducer Not Connected. Check the
connection of the transducer to the AccelStim
device and press the function button to restart
the treatment.
Three short
beeps every 3
seconds.
Treatment Not Allowed. The AccelStim device
allows a maximum of two treatments per
day. Only complete two treatments per day if
instructed by your physician. If two treatments
have been completed, no other treatments are
allowed. The AccelStim device will switch off
automatically after 30 seconds.
*The second treatment must be completed by
midnight on the current day.
Three short
beeps every 3
seconds.
Expired Device Life: The AccelStim device
provides daily treatment for up to 365 days
from date of first use. The AccelStim device
switches off automatically after 30 seconds.
Contact Patient Service at 1-800-535-4492.

13
Display Message Audio Signals Problem and Solution
Three short
beeps every 3
seconds.
Fault Detected. If the AccelStim device detects an
anomaly in the transducer or device operation,
treatment is stopped. Check the presence of gel on
the transducer which must form a 1-2 mm thick
layer to the transducer. Then restart the treatment
by pressing the function button. If the message
remains after checking the gel, turn the device off
and contact Patient Services at 1-800-535-4492
*All three visual and audio alerts in this section
have the same meaning.
Three short
beeps every 3
seconds.
Problem Detected. If the display shows these
two symbols in sequence, a problem has been
detected. The AccelStim device will switch off
automatically after 5 seconds. Contact Patient
Services.
No Audio
Internal Battery Damaged. Recharging the Accel-
Stim device is not possible but it is still possible to
perform the treatment by connecting the device to
the external power supply. Please contact Patient
Services for device replacement.
When performing the treatment with a faulty
battery, the AccelStim device will automatically
start in treatment mode a few seconds after the
power supply is connected and in the upper right
corner of the screen the battery symbol with an X
will be displayed.
At the end of the treatment, it is necessary to
disconnect the power supply from the AccelStim
device to power down the device. In the case of
a faulty battery, it is not possible to turn on the
AccelStim device to calendar mode.
*The two visual alerts in this section have the same
meaning.
No Audio
Three short
beeps every
3 seconds.
Three short
beeps every
3 seconds.
Three short
beeps every
3 seconds.

14
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 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
15 cm (6 inches).
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 for
assistance.
DEVICE APPLICATION
Step-by-step instructions for device application can be found in the table on the
following page. The transducer must be placed inside the transducer holder which is
connected to the strap (as seen in the image below). The transducer holder must be
placed directly over the treatment area.
The supplied gel must be applied to the side of the transducer with no writing. Before
starting a treatment, apply a thick layer (1-2mm) of gel to the transducer. Gel is
necessary to allow ultrasound transmission to the treatment area. If you feel your skin
is sensitive to the gel, you may change the gel to mineral oil or glycerin.
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.

15
Connect the transducer to the AccelStim device by inserting the transducer
cord into the transducer port.
Wear the strap on the area to be treated and secure it with the Velcro
attached to the elastic strap. The strap should be snug, but comfortable,
against the skin to prevent motion or slippage from over the fracture site. Do
not overtighten the strap. Excess strap can be cut by the user.
Open the blue cover of the transducer holder by rotating it.
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.
Insert the transducer inside the strap so that the serial number is visible and
then close the blue cover by rotating it.
Turn on the device by pressing the on/off button for two seconds. Once you
hear a beep, release the button, and the display lights up. The Orthofix logo
will appear on the display screen. The device is now ready for treatment and
will display 20 minutes of treatment time along with a play symbol. The gel
symbol will flash for 10 seconds to remind the user to apply the ultrasound
gel on the transducer before starting treatment.
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 and the
animation indicating the correct operation. Pressing the function button,
the treatment will pause and the remaining time is stopped and the pause
symbol will appear. To resume treatment, press the function button again.
At the end of the daily treatment the display shows the symbol of a
checkmark and emits three long beeps. After 30 seconds the AccelStim
device will turn off automatically. Open the blue cover of the strap and
remove the transducer. As described in the Care and Cleaning directions
page 20, remove the strap from the treatment site and clean all of the
remaining gel.

16
PATIENT ADHERENCE
The AccelStim device is equipped with an internal memory that records compliance
related to treatments performed up to 365 days from the first use. Both the day and
the duration of the treatment performed on that day are recorded and displayed as a
calendar.
• Day/Date on black background, no treatment performed.
• Day/Date on yellow background, treatment lasting less than 20 minutes.
• Day/Date on green background, treatment performed correctly.
• Day /Date on green background and along with a + symbol, more than one 20 minute
treatment performed .
Treatment data is displayed in read-only mode and cannot be changed by the user.
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

17
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
To enter calendar mode, the AccelStim device should be
off. To begin entering calendar mode,, hold down the On/
Off button for at least 5 seconds until you hear a short beep
followed by a longer beep.
The display will show data recorded in the first month
of treatments, as shown in the image. In the upper right
corner, a small image with three dots means that other
months are going to be displayed.
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
After 5 seconds, the display will automatically switch to
treatments recorded during in the following month.
Icons in the lower right hand corner appear indicating the
USB portable storage device is inserted into its connector
(USB symbol) and the prior month (curves arrow) is being
shown on the screen.
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
Pressing the function button will pause the sequence and
in the upper right corner a small image with a pause symbol
will display. Pressing the function button again will restart
the sequence.
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
The sequence stops on the last month of treatment data
and in the upper right corner a small image with a stop sign
symbol will display. Pressing the function button again will
restart the sequence from the beginning.
To exit Calendar Mode, and turn off the device, press and hold the On/Off button until
you hear a short 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
July 2022

18
Treatment Data Export
The user can export treatment data to a portable USB storage device. In order to do
this, please proceed as follows:
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 symbol appears on the bottom right corner along with an arrow indicating data
has been saved on the portable USB storage device, in the file labeled “AccelStimTrtLog.
txt.” If the file already exists on the portable USB storage device, data is added to the
existing file.
4. After five seconds, the next month is displayed and data is saved on the portable
storage device
in the file “AccelStimTrtLog.txt”; this step is repeated for each displayed
month
.
5. Data saving ends when the display shows last month of the registered treatments and
the symbol √ is shown next to the symbol .
6. Remove the portable USB storage device and analyze the data with a PC. In case of
Excel, please use the function “import data from file.”
In case the user restarts the calendar sequence by pressing the function button while
the portable USB storage device is still connected to AccelStim, the treatment data will
be saved again in the same file “AccelStimTrtLog.txt,” at the end of the previous data.
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.
DEVICE USE AND CARE
Closely follow these instructions to ensure optimal and safe operation of the device.
• The AccelStim device is for single patient use.
• The AccelStim device is an advanced technology electronic device and should be
handled with care. Dropping or other mishandling of the AccelStim device may damage
the device and it may stop working.
• For safe usage, follow the instructions when using the AccelStim device. The patient is
the intended operator of this device.
• Use of the device in any other manner could have harmful effects and/or void the
warranty.
• The use of accessories other than those specified may result in increased emissions or
decreased immunity of the device.
• Inspect the device prior to each use for wear, deterioration or damage.
• Do not use or charge the device if it does not appear to be in a suitable condition,
displays an error or stops working. Contact Patient Care Services if any of these occur.
WARNING: Do not modify this equipment as this could make it unsafe to use. Do not
attempt to open or disassemble the AccelStim device as there are no user serviceable
parts inside.

19
• A comprehensive understanding and ability to follow the instructions provided in
this manual are critical for the use of the AccelStim device. Users who cannot read,
understand, and/or follow these instructions should be carefully and closely supervised
during use.
• Handle all parts of the device with care to prevent damage to the device; in particular,
handle the transducer with care, avoiding impacts, violent blows or falls that could
compromise the operation of the device.
• After use, place all parts of the device in the supplied box.
• Before using the device, make sure the display is sufficiently visible.
• 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 overtighten the elastic strap. The strap should be snug, but comfortable, against
the skin to prevent motion or slippage of the transducer from the fracture site.
• 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.
• 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.
• 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.
• 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.
• Before use, always check for visible damage to the power supply; never use a damaged
power supply. In case of damage, replace the power supply by contacting Patient
Services at 1-800-535-4492.
• 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.
• The internal battery must not be removed. If the device is not charging properly, please
contact Patient Services at 1-800-535-4492 for a replacement. The battery must be
disposed of in compliance with waste material directives and local laws.
• 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 User Manual.
• Contact Patient Services
at 1-800-535-4492 if you need additional gel in order to
complete your prescribed treatments.