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ALPHA-STIM M - PRESCRIBING INFORMATION CONTINUED; Device Contraindications; Usage Precautions and Safety; Potential Adverse Effects

ALPHA-STIM M
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28
efficacy will vary with the nature of the problem being treated, the overall health of
the person, and with the method of treatment. As much as a one month initial trial
may be required to see significant reductions in symptoms.
Contraindications
The Alpha-Stim
®
M may affect the operation of implanted demand type cardiac
pacemakers and implanted defibrillators. Do not stimulate directly on the eyes, or
press the probes over the carotid sinus (on the neck near the larynx).
Precautions
For external use only. Do not allow children to use or handle this device without
adult supervision. Do not operate potentially dangerous machinery or vehicles
during treatment, and in some cases for several hours after treatment if the user
experiences profound relaxation. Caution is advised in cases where other forms of
analgesia (pain control) would not be used; such as to retain the beneficial aspects
of pain for diagnosis or in cases where people may overuse pain-controlled areas.
Safety of stimulation has not been established during pregnancy. There have been
reports of blood pressure being lowered in hypertensive patients by CES. Blood
pressure should be monitored in people on blood pressure medications and the
medication dosage should be lowered by the prescribing physician as necessary.
Adverse Effects
Adverse effects are usually mild and self-limiting. Adverse effects from data on
approximately 8,792 patients participating in 144 controlled studies, open clinical
trials, and uncontrolled conditions, and by physician survey and reasonably
associated with the use of CES are dizziness (6 cases, 0.07%), skin irritation/electrode
burns (6 cases, 0.07%), and headaches (9 cases, 0.10%). Prolonged CES treatment at
currents higher than necessary may cause dizziness or nausea that can last for hours
to days. Treatment immediately prior to going to sleep may cause difficulty sleeping
due to increased alertness. Paradoxical reactions such as hyperexcited states,
increased anxiety, and sleep disturbances may occur, but are rare.
If the Alpha-Stim
®
M does not begin to control your insomnia or pain within
one month, consult your health care practitioner, authorized Alpha-Stim
®
distributor, or EPI.

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