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Risks and Benefits
• The safety of the OL1000 or OL1000 SC is not known if you are pregnant or
nursing a baby .
• The safety and benefit of the OL1000 or OL1000 SC are not known for
people whose bones are still growing (generally 18 years old or less) .
• Testing of the OL1000 or OL1000 SC in animals and people has not found
any safety problems . However, the chance of safety problems with long
time 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 or
OL1000 SC is not intended to help it become less crooked as it heals .
• The safety and benefit of the OL1000 or OL1000 SC are not known for a
non-healing broken bone that is caused by a disease rather than an injury .
• Do not use the OL1000 or OL1000 SC if you are unwilling or 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 or OL1000 SC may not work as well .
• The device may not work properly and your treatment may be longer un-
less 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 or OL1000 SC 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 or OL1000 SC near products that may have
strong magnetic 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 equip-
ment . 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 equipment,
and by not using other equipment (i .e . cell phones, MRI, electro surgery,
defibrillation, etc .) when you are using this device .
