CMF OL1000 SC Size 1 User manual

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Patient Manual
OL1000 SC Size 1
Bone Growth Stimulator
Please read before using device
Caution: Federal law (U.S.A. and
Canada) restricts this device to
sale, distribution or use by or on
the order of a physician.
REF 01-211-0001

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Table of Contents
User Profile........................................................................................................... 2
Purpose of the Device......................................................................................2
Description of the Device............................................................................... 3
When the Device Should Not be Used...................................................... 3
Risks and Benefits.............................................................................................. 4
Warnings ..................................................................................................................4
Cautions................................................................................................................ 5
Contents ...............................................................................................................6
Directions for Use ............................................................................................6
Putting on the Device............................................................................ 6
Starting Each Day’s Treatment............................................................ 6
OL1000 SC1................................................................................................ 7
Display Screen...........................................................................................8
Checking the Treatment Record.........................................................8
Safe Battery Care Information............................................................. 8
Replacing the Batteries in the OL1000 SC1.................................... 9
Additional Information........................................................................10
Device Care and Storage ....................................................................10
Use While Traveling.........................................................................................10
Troubleshooting Information .....................................................................11
User Assistance Information........................................................................13
Customer Care Telephone Numbers ........................................................13
Appendix A – Shoulder (Clavicle) Use......................................................14
Appendix B – Hand/Wrist (Metacarpals and Phalanges) Use..........15
Appendix C – Foot/Ankle (Metatarsals and Phalanges) Use............16
Symbols ..............................................................................................................17
Electromagnetic Compatibility (EMC) .....................................................18
Warranty .............................................................................................................23
Product Specifictions.....................................................................................24

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Do not use this product before you read this manual very carefully.
If you have questions, please call your doctor or Customer Care. See
page 13 for the Customer Care telephone number in your area.
Physician Manuals for CMF products can be found at
http://www.djoglobal.com/ol1000
Figure 1. OL1000 SC1 Bone Growth Stimulator
User Profile
Patients, a patient’s caretaker, or a family member providing assistance
can use this device. The user should be able to:
• Read and understand the directions, warnings and cautions.
• Place the device on the patient.
• Be able to see or hear device signals.
• Understand the treatment schedule as prescribed.
Purpose of the Device
Your doctor has asked you to use the OL1000 SC1 device (Figure 1,
above) for your broken bone that will not heal (called“non-healing” or
“nonunion”). When used properly, the device will produce a magnetic
field over your broken bone. This field is meant to help the bone heal.
To treat yourself, you must wear the device on the outside of your body
for 30 minutes per day.

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Description of the Device
The OL1000 SC1 is very easy to use, comfortable to wear, and safe
to use. It is designed to create a magnetic field that stimulates your
broken bone to heal. You will not feel the magnetic field the device
produces when using it. The device has a single“push button” to start
your treatment and will automatically shut off after 30 minutes. Each
day you will hear one beep when you start treatment and two beeps
when your treatment is complete. If you hear beeps before your
30-minute treatment is finished, a picture will be shown on the display
screen. Refer to the Troubleshooting Information section on page 10
for help. The device records the number of days that it has been used.
This number will appear on the display screen. This feature allows you
and your doctor to keep track of your care.
When the Device Should Not be Used
• Do not use without the prescription of a doctor.
• Do not use the OL1000 SC1 if you have a synovial pseudarthrosis
(condition where scar tissue forms between the ends of broken bone and
prevents healing).
• Do not use the OL1000 SC1 if you have a heart pacemaker or defibrillator
unless your heart doctor has approved it.
• Do not use the OL1000 SC1 if you have an implant made from magnetic
materials at the site of your non-healing broken bone. Almost all implants
used today are non-magnetic.

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Risks and Benefits
• The safety of the OL1000 SC1 is not known if you are pregnant or
nursing a baby.
• The safety and benefits of the OL1000 SC1 are not known for people
whose bones are still growing (generally 18 years old or less).
• Testing of the OL1000 SC1 in animals and people has not found any
safety problems. However, the chance of safety problems with long
term use of this device in people is not known.
• Do not put weight on your broken bone if the bone pieces are able
to move.
• If your non-healing broken bone is crooked, note that the OL1000 SC1
is not intended to help it become less crooked as it heals.
• The safety and benefits of the OL1000 SC1 are not known for a non-
healing broken bone that is caused by a disease rather than an injury.
• Do not use the OL1000 SC1 if you are unwilling or unable to follow
your doctor’s orders or the device instructions.
• If you have bone loss or if your broken bone has been unhealed for a
very long time, the OL1000 SC1 may not work as well.
• The device may not work properly and your treatment may be longer
unless you do the following:
– Always follow your doctor’s instructions
– Always follow your daily treatment schedule
– Always change the batteries when they need it
– Always take proper care of the device
• The benefit of the OL1000 SC1 is that you have a greater chance of
healing if you use the device than if you do not use it.
Warnings
• Do not use the OL1000 SC1 near products that may have strong mag-
netic fields, such as audio speakers. The device may not work properly
around these products.
• WARNING! This device is intended only for single patient use. Secondary
use can cause serious injury, including infection.
• Care must be taken when operating this device adjacent to other
equipment. Potential electromagnetic or other interference could
occur with this or other equipment. Try to minimize this interference
by increasing the separation between this device and nearby equip-
ment, and by not using other equipment (i.e. cell phones, MRI, electro
surgery, defibrillation, etc.) when you are using this device.

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• The equipment should not be used adjacent to or stacked with other
equipment and, if adjacent or stacked use is necessary, the equipment
should be observed to verify normal operation in the configuration in
which it will be used.
• Do not use the OL1000 SC1 while smoking or near heat, fire or
flammable gases because the device may be damaged.
• Do not use the OL1000 SC1 if there are exposed wires or the device
appears damaged.
• Do not modify or repair this device because you may damage it.
• Do not put the device or any of its parts in any liquid.
• Do not drop the device or bend the coils because this may damage it.
• Device is designed to comply with electromagnetic safety standards.
However, there is no guarantee that interference will not occur in a
particular installation. Harmful interference to other devices can be
determined by turning this equipment on and off. Try to correct the
interference using one or more of the following:
– Reorient or relocate the receiving device.
– Increase the separation between the equipment.
– Contact DJO Customer Care.
• Some people, with very sensitive skin, may experience redness.
Generally, this redness is totally harmless and usually disappears after
10 to 20 minutes. However, never start another treatment on the same
area if the redness is still visible.
• If the performance of the device varies in any way from the described
operation, call Customer Care.
• The use of other cables and accessories may affect EMC performance.
• This device and its accessories must be kept out of the reach of
children, Pets, and Pests.
• Do not use device in contact with open wounds.
• Contamination by Patient could be sweat, expired gases, saliva, on the
Spinal Logic. Clean the applied part of the coil once a week using soap
and a damp cloth.
• Do not use device while in bath or shower.
Cautions
• DO NOT operate this unit in an environment where other devices are
being used that intentionally radiates electromagnetic energy in an
unshielded manner. Portable and mobile RF communications
equipment can affect Medical Electrical Equipment.

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Contents
Directions for Use
CAUTION: Never use the device if the temperature around you is
lessthan 41°F or over 104°F (5°C to 40°C) or the device may not work
properly. The device should be in this temperature range for one hour
before treating.
No User Serviceable parts inside. Do not attempt to modify or repair
this product. Please contact the Manufacturer for assistance in setting
up, using, or maintaining this product. Contact manufacturer for
assistance to report unexpected operation or events.
Putting on the Device
Your doctor or a service representative will:
• Show you how to place the device correctly over the spot of your non-
healing broken bone;
• Show you how to use the latch or straps to hold the device in place, if
needed; and
• Show you how to use the device.
Starting Each Day’s Treatment
• Put the device on as you were shown.
• Use the device as you were shown.

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OL1000 SC1
For examples of how to place the OL1000 SC1 on various areas of the
body, please see the appendices.
Figure 2. OL1000 SC1
1. Center the device’s coil around the broken bone. (See illustrations in
appendices.)
2. Close the strap.
3. To start a treatment, press the“push button”next to the liquid crystal
display (LCD) screen (see Figure 2), hold it down until it beeps, and then
let go.
a. The treatment record will be displayed until it beeps.
b. The 30-minute treatment countdown will begin.
c. After 30 minutes, the“treatment complete” icon will appear on the
LCD screen, the device will beep twice and it will automatically shut off.
4. Remove the device and store it until the next day. Please see the Device
Care and Storage section on page 9 for instructions on the proper
storage of the device.
LCD
Push Button

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Display Screen
When using the device, the LCD screen will show the time remaining
for your daily treatment. The screen may look like this:
In this example, there are 29 minutes and 37 seconds remaining in the
30-minute treatment.
Checking the Treatment Record
You may check your treatment record at any time, except during your
daily 30-minute treatment. To view the treatment record, press the
“push button”and then let go before it beeps. The LCD screen will look
like this:
Number of days
successfully treated
Number of days
since first treatment
The number in the left-hand corner of the OL1000 treatment record is
the number of days you have successfully treated. The number in the
right-hand corner is the number of days since you first used the device.
If the daily treatment has already been completed for that day, and the
“push button”is pressed, the treatment record will be shown followed
by the“treatment complete” icon. This is a reminder that your daily
treatment has already been completed for that day.
Safe Battery Care Information
• Never heat or throw the batteries in a fire.
• Never charge the batteries.
• Never let the battery ends contact each other or other metal. Do not
let a piece of metal touch both ends of a battery at the same time.
• Never damage or use damaged batteries.
• Never mix old and new batteries together or use batteries other than
in their correct position.
• Always keep batteries at room temperature, about 70°F (20°C) in less
than 80% relative humidity and out of direct sunlight.
• Only use the batteries supplied in the carrying case with the OL1000 SC1.
• Remove primary batteries when equipment is not likely to be used for
some time to avoid battery leakage.
• The batteries may be replaced only after the display turns off.
Note: Be sure to remove plastic from batteries before replacing them.

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Replacing the Batteries in the OL1000 SC1
WARNING: Battery operated device (9V alkaline battery), not to use
lithium batteries.
The LCD screen will show the following picture when it is time for
new batteries. This picture will be shown at the start of a treatment
or during a treatment. The device will turn off after this picture is
displayed.
Never change the batteries when the device is running. Wait until the
device stops operating to change the batteries.
For the OL1000 SC1, the picture in Figure 3, below, shows the correct
way to replace the battery. When replacing the battery, you will see the
correct way to put them in on the inside of the battery compartment.
Use ONLY the batteries supplied with the OL1000 SC1. They are located
in the carrying case.
Note: Be sure to remove plastic from batteries before replacing them.
Figure 3. OL1000 SC1 – Battery Compartment

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Additional Information
• The device can be used ONLY 270 days in a row (about nine months).
Use the device as long as your doctor tells you to.
• Please take the device with you every time you go to your doctor.
• In clinical studies, the earliest time to heal was three months. The
average time to heal was six months. Some non-healing broken bones
may take longer to heal.
• There are alternatives to using the OL1000 SC1. These include having
surgery or using other medical devices. Please ask your doctor if you
have any questions about other choices for treating your non-healing
broken bone.
Device Care and Storage
• Clean the surface regularly with a damp cloth.
• Always store the device in its carrying case in a cool, dry place. Never
keep it where the temperature is less than 41°F (5°C) or greater than
104°F (40°C). Temperatures below or above could damage the device.
• Never store the device or any of its parts in an automobile in cold or
hot weather.
• Always store the OL1000 SC1 in the carrying case provided with the
device. The carrying case will protect the device when not in use. It
also stores the extra batteries and this manual.
• To avoid the risk of choking or strangulation, always store the OL1000
SC1 in its carrying case out of reach of small children.
Use While Traveling
You should try to use the OL1000 SC1 at the same time every day. The
clock inside the device counts each day starting at midnight Pacific
Standard Time (PST), 8:00 AM Greenwich Mean Time (GMT), or 7:00 AM
(GMT) during daylight savings, and will only allow one treatment every
24 hours. If you travel outside of your normal time zone, you should try
to treat at the same time you normally would at home. Do not take the
OL1000 SC1 through airport x-ray machines because the x-rays may
damage the device.

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DISPLAY PICTURE ACTION TO BE TAKEN
Magnetic Interference – announced by
three beeps. The “X” will flash.
1. If the device looks damaged, call
Customer Care.
2. If not, try moving to another location
in your house. Make sure you are not
near metal objects.
3. If the picture is still displayed, replace
the batteries with new ones.
4. If the device still shows the picture,
call Customer Care.
Replace Battery – announced by three
beeps. Replace the batteries with new
ones.
Phone For Help – announced by three
beeps. Call Customer Care.
Troubleshooting Information
If you hear beeps before your 30-minute treatment is complete, there
may be a problem with your device. Look at the LCD screen for a picture.
Table 1 below shows pictures that may appear on the LCD screen and
other common problems (left side of table). The action to take for each
picture or problem is on the right side of the table.
TABLE 1: DISPLAY MESSAGES

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PROBLEM ACTION TO BE TAKEN
The device will not turn on, but
there is no error message. You may
still hear a beep.
1. Try replacing the batteries with
new ones.
2. Wait until tomorrow and try
treating again.
3. If the device still will not turn on,
call Customer Care.
There are lines or bars on the
display or the display is too dark
to read.
Call Customer Care.
You do not hear any beeps.
1. The beeper may not work if you
live where it is very humid. The
device will still work.
2. If you do not live where it is
humid, listen again tomorrow
for beeps. Have somebody else
listen too.
3. If the device still does not beep,
call Customer Care.
The device appears damaged. Call Customer Care.
Your broken bone hurts more than
it used to.
1. Make sure that you are treating
in a comfortable, relaxed posi-
tion.
2. If you still have more pain than
you used to, call your doctor.
You run out of batteries. Call Customer Care.
Troubleshooting information, continued

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DISPLAY PICTURE DEFINITION
Treatment record.
Time remaining in 30-minute daily
treatment.
Daily treatment successfully
completed – announced by two
beeps.
Please wait.
User Assistance Information
For servicing of the OL1000 SC1 or for further information concerning
the use of the device, please contact Customer Care. When your
treatment is completed, you should take it to your local recycle center
where the unit may be taken in as an electric recycle, like a television or
computer. You may also contact Customer Care for assistance with
device disposal. The OL1000 SC1 is not reusable. These devices are
intended for single patient use only. It cannot be re-sold or used on
multiple patients.
Customer Care Telephone Numbers
United States 800.263.6004
Canada 800.263.6004
Europe T +44.1483.459.659
F +44.1483.459.470
A summary is shown below of other pictures that
may appear on the LCD screen

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Appendix A – Shoulder (Clavicle) Use
1. Remove liner pad. (Figure 2)
2. Remove Velcro tab “A” and loosen strap.
(Figure 1)
3. Feed strap through slot until it is free,
leaving the strap attached only on
the side of the unit with the cord.
4. Attach long strap to the open slot.
5. Replace liner pad. (Figure 2)
6. Center treatment coil over fracture
site as prescribed by your physician.
(Figure 3)
7. Longer strap should fall down the
back, and the shorter strap and
cord should fall down the front.
(Figure 4)
8. Bring the longer strap around the front
of the torso, and attach to the
short strap making sure the unit is se-
cured over the fracture site.
(Figure 4)
Figure 1
Figure 2
Figure 3
Figure 4
OL1000 SC1 Application Instructions

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Appendix B –
Hand/Wrist (Metacarpals
and Phalanges) Use
1. Remove Velcro tab “A” and loosen
strap. (Figure 1)
2. If unit is to be applied over a cast,
remove liner pad. Otherwise, leave
liner pad installed. (Figure 2)
Option 1
3. Place hand through strap opening.
(Figure 3)
4. Center treatment coil directly over
fracture site as prescribed by your
physician and secure strap. (Figure 4)
5. Place hand/wrist on a stable surface
with the palm facing down (Figure 3)
6. To tighten or loosen the strap, remove
and reposition Velcro tab“A”. Adjust
strap until it feels comfortable and
secure. (Figure 1)
Option 2
7. Place the coil on a stable surface with
the softgood facing up. (Figure 5)
8. Center the treatment site on top of
the softgood pad and secure the
strap. (Figure 4)
9. To tighten or loosen the strap, remove
and reposition Velcro tab“A”. Adjust
strap until it feels comfortable and
secure. (Figure 1)
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
OL1000 SC1 Application Instructions

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Appendix C – Foot/Ankle (Metatarsals
and Phalanges) Use
1. Remove Velcro tab “A” and loosen
strap. (Figure 1)
2. If unit is to be applied over a cast,
remove liner pad. Otherwise, leave
liner pad installed. (Figure 2)
3. Place foot through strap opening.
(Figure 4)
4. Center treatment coil directly over
fracture site as prescribed by your
physician and secure strap.
(Figure 3)
5. To shorten or lengthen the strap,
move Velcro tab“B”along the strap.
(Figure 1)
6. To tighten or loosen the strap, re-
move and reposition Velcro tab “A”.
(Figure 1)
Figure 2
Figure 1
Figure 4
Figure 3
OL1000 SC1 Application Instructions

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Equipment Safety Electric
Shock Classification Type
BF Applied Part
Warning or Caution
Refer to Instruction
Manual/Booklet
Manufacturer
Temperature Range
Waste of electrical and
electronic equipment
must not be disposed as
unsorted municipal waste
and must be collected
separately. Contact an
authorized representative
of the manufacturer for
information concerning
the decommissioning of
your equipment.
Protected against solid
foreign objects of
12.5mm dia and greater.
Protected against
vertically falling water
drops when enclosure
tilted up to 15º.
Keep Dry
Authorized Representative
in the European
Community
CE Mark of Conformity
Conforms to ANSI/AAMI
Std. ES60601-1
Certified to CAN/CSA Std.
C22.2 No. 60601-1
REF Catalogue Number
SN Serial Number
Atmospheric Pressure
Range
Humidity Range
Symbols
The markings on the SpinaLogic Bone Growth Stimulator are your
asurance of its conformity to the highest applicable standards of medical
equipment safety and electromagnetic compatibility. One or more of the
following markings may appear on the device and/or packaging:

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Compliance Statements
Electromagnetic Compatibility (EMC)
The Bone Growth Stimulator has been tested and found to comply with
the electromagnetic compatibility (EMC) limits for medical devices to
IEC 60601-1-2. These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation.
Caution: Medical electrical equipment requires special precautions
regarding EMC and must be installed and operated according to these
instructions. It is possible that high levels of radiated or conducted
radio-frequency electromagnetic interference (EMI) from portable and
mobile RF communications equipment or other strong or nearby radio-
frequency sources, could result in performance disruption of the system.
Evidence of disruption may include image degradation or distortion,
erratic readings, equipment ceasing to operate, or other incorrect func-
tioning. If this occurs, survey the site of disruption, and take the following
actions to eliminate the source(s).
• Turn equipment in the vicinity off and on to isolate disruptive equipment.
• Relocate or reorient interfering equipment.
• Increase distance between interfering equipment and your system.
• Manage use of frequencies close to the system frequencies.
• Remove devices that are highly susceptible to EMI.
• Lower power from internal sources within the facility control (such
as paging systems).
• Label devices susceptible to EMI.
• Educate clinical staff to recognize potential EMI-related problems.
• Eliminate or reduce EMI with technical solutions (such as shielding).
• Restrict use of personal communicators (cell phones, computers) in
areas with devices susceptible to EMI.
• Share relevant EMI information with others, particularly when evaluating
new equipment purchases which may generate EMI.
• Purchase medical devices that comply with IEC 60601-1-2 EMC Stan-
dards (3V/meter EMI immunity, limit interference level to 0.0014 V/
meter).