ReActiv8 Safety Information
ALWAYS READ THE INSTRUCTIONS FOR USE. Refer to user manual for a complete listing of indications, warnings, precautions, potential adverse events, and directions for use. If symptom persist, worsen or change unexpectedly, talk to your health professional.
Intended Purpose/Indications for Use: The ReActiv8 System is indicated as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing.
- It is very important that you inform your physician or other healthcare professional (e.g. physical therapist, chiropractor, dentist, etc.) that you are implanted with the ReActiv8.
- Magnetic Resonance Imaging (MRI) – You SHOULD NOT have an MRI scan, as it may be hazardous for you.
- Diathermy – You SHOULD NOT receive diathermy therapy, as it may be hazardous for you.
- Strangulation by cable – When operating the Activator, keep the antenna cable away from your neck to avoid strangulation. Do not allow children to handle or play with the Activator.
- Case damage – If the case that the Activator is pierced or ruptured, burns could result from exposure to battery chemicals.
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