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2.2.4 Adverse Reactions
1) Possible skin irritation or electrode burn under the
electrodes may occur.
2) Possible allergic skin reaction to tape or gel may occur.
3) If the stimulation levels are uncomfortable or become
uncomfortable, reduce the stimulation intensity to a
comfortable level and contact your physician if problems
persist.
4) Patients may experience skin irritation and burns beneath
the stimulation electrodes applied to the skin.
5) 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.
6) Patients should stop using the device and should consult
with their physicians if they experience adverse reactions
from the device.
25) Use caution when the patient has a tendency to bleed
internally, such as following an injury or fracture.
26) Safety of powered muscle stimulators for use during
pregnancy has not been established.
27) Caution should be used for patients with suspected or
diagnosed epilepsy.
28) Caution should be used in the presence of the following:
29) When there is a tendency to hemorrhage following acute
trauma or fracture;
30) Following recent surgical procedures when muscle
contraction may disrupt the healing process;
31) Over the menstruating or pregnant uterus; and
32) Over areas of the skin that lack normal sensation.
