11
ADVERSE REACTIONS:
1. Skin irritation, inflammation, and electrode burns beneath the
electrodes are potential adverse reactions.
2 Patients may experience headache and other painful sensations
during, or following the application of, electrical stimulation near
the eyes and to the head and face.
3 The clinician should stop using this device and should consult with
the patient’s attending physician should the patient experience any
adverse reactions from treatment used with this device.
Note: Always use devices that are legally marketed and sold in the
United States under 510K guidelines.
4. If the stimulation levels are uncomfortable, reduce the stimulation
intensity to a comfortable level and contact your physician if any
problems persist.