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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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