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EN
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
®
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. 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