Algostim Algovita 4300, User Manual, Page: 12 / 36

8
Trial Stimulator Manual
Important Safety Information
• CT scans may damage the EPG if stimulation is on. CT scans are unlikely to damage the EPG
if stimulation is turned off.
If any of the therapies or procedures listed above are required by medical necessity:
• Adjust stimulation to its lowest level before the procedure or application then turn the EPG off.
• All equipment, including ground plates and paddles, must be used as far away from the EPG as
possible.
• Every effort should be taken to keep fields, including current, radiation, or high-output
ultrasonic beams, away from the EPG.
• Set equipment to the lowest energy setting clinically indicated.
• Verify SCS system and therapy function following treatment.
Component Compatibility. Use only the Clinician Programmer, or an Algovita patient
programmers and accessories in your Algovita SCS System to adjust stimulation. The effects of
non-Algovita components on an Algovita SCS System are unknown.
Flammable Atmospheres.
Avoid using the EPG in flammable or explosive environments (eg,
an anesthetic mixture with air, oxygen, or nitrous oxide). Using a battery-powered device near
flammable or explosive atmospheres can produce a spark which may cause injury..
Adverse Events
There are potential risks involved with any surgery. The possible risks of using a trial stimulation
system are similar to the risks that can occur with other spinal procedures. These risks include:
• The most common risks are temporary pain at the incision or infection.
• There is a small possibility of developing a cerebral spinal fluid (CSF) leak.
• In rare cases bleeding (epidural hemorrhage), a blood clot (hematoma), or a pocket of fluid
(seroma) may develop at the location where leads are placed.
• In rare cases, injury to the spinal cord may occur, resulting in paralysis.
• The use of blood thinners may increase the risk of complications such as blood clots
(hematomas), which may produce paralysis.
The possible risks of using a trial stimulation system to evaluate a treatment for chronic pain
include:
• The leads may shift or move from the location where they were originally implanted. Such a
change in location may cause changes in stimulation, sometimes unpleasant, and/or reduce