English
Page | 5
S
AFETY
I
NFORMATION
C
ONTRAINDICATIONS
•
Poor surgical risks
–
Spinal cord stimulators should not be used on patients
who are poor surgical risks or patients with multiple illnesses or active
general infections. This includes patients who need anticoagulation
therapy that cannot be temporarily halted to accommodate the
implantation procedure.
•
Pregnancy
–
Safety and effectiveness of the Freedom SCS System for use
during pregnancy and nursing have not been established.
•
Inability to operate System
–
Spinal cord stimulators should not be used
on patients who are unable to understand or operate the System.
•
Exposure to shortwave, microwave, or ultrasound diathermy
–
Diathermy
should not be operated within the vicinity of a patient implanted with a
Freedom Stimulator or when wearing the Wearable Antenna Assembly
(WAA). The energy from diathermy can be transferred through the
stimulator or WAA and cause tissue damage, resulting in severe injury.
•
Implanted cardiac systems
–
Patients who have implanted cardiac systems
should not use the Freedom SCS System. Electrical pulses from the
Freedom SCS System may interact with the sensing operation of an
implanted cardiac system, causing the cardiac system to respond
inappropriately.
•
Occupational exposure to high levels of non-ionizing radiation that may
interfere with therapy
–
Users who regularly work in environments with
elevated levels of non-ionizing radiation should not be implanted with the
Freedom SCS System. The energy in high-level areas can be transferred
through the stimulator and cause tissue damage, resulting in severe injury.
Examples of environments having high level non-ionizing radiation includes
radio or cell phone transmission stations, facilities using radiofrequency
heat sealers or induction heaters, electric power infrastructure controlled
environments (i.e. step down transformers or high voltage power lines).
