Description Of The Device; When The Device Should Not Be Used; Risks And Benefits - CMF SPINALOGIC Manual De Instrucciones

Description of the Device

SpinaLogic (Figure 1, above) is very easy to use, comfortable to
wear, and safe to use. It is designed to create a magnetic field
that stimulates your backbone to heal. You will not feel the
magnetic field it produces when using it. The device consists of a
control box (A), a treatment coil (B), and a waist belt (C). It has a
single "push button" on the control box 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 12 for help. The device also records the number of days
that it has been used, which 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 SpinaLogic
defibrillator.
• Do not use SpinaLogic if you are pregnant or if you become
pregnant.

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.
® if you have a heart pacemaker or
3