Risks And Benefits; Warnings - CMF SpinaLogic Manuel

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Risks and Benefits

• SpinaLogic was not studied on patients who also have metal implants
at the spot of their back surgery . Metal implants should not affect your
treatment .
• The safety and benefit of SpinaLogic is not known for people whose
bones are still growing (generally 18 years old or less) .
• If you have any of the following medical problems, it is not known if
the device will work for you: osseous or ligamentous spinal trauma,
spondylitis, Paget's disease, severe osteoporosis, metastatic cancer,
renal disease, or uncontrolled diabetes mellitus .
• Animal testing with this device 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 use SpinaLogic if you are unwilling or unable to follow your
doctor's orders or the device instructions .
• 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 SpinaLogic is that you have about a 20% greater chance
of your back surgery healing if you use the device every day than if you
do not use it .

Warnings

• Do not use SpinaLogic
fields, such as audio speakers . The device may not work properly
around these products .
• WARNING! This device is intended only for single patient use . Second-
ary use can cause serious injury, including infection .
• Care must be taken when operating this equipment around other
equipment to avoid reciprocal interference . Potential electromagnetic
or other interference could occur to this or to the other equipment . Try
to minimize this interference by not using other equipment when you
are using this device .
• The equipment should not be used adjacent to or stacked with other
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near products that may have strong magnetic