Dear Patient; Purpose Of The Device; Description Of The Device; When The Device Should Not Be Used - CMF SPINALOGIC Patientenhandbuch

Dear Patient,

Do not use this product before you read this manual very
carefully. If you have questions, please call your doctor or
Customer Care. See page 14 for the Customer Care telephone
number in your area.
Words that are written in italics and look like this, "Words", are
explained in the "Glossary of Medical Terms" on page 15.

Purpose of the Device

Your doctor has asked you to use the SpinaLogic
back after your back surgery (primary lumbar spinal fusion
surgery of one or two levels) to help your backbone heal. When
used properly, this device will produce a magnetic field over the
spot of your back surgery. This field is meant to help the bones
heal. To treat yourself, you must wear the device on the outside of
your body for 30 minutes per day.
C
A
Figure 1. SpinaLogic
2
® device on your
B

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 ® if you have a heart pacemaker or
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.
3