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Prescribing Information
CE conformity statement for Europe:
The Alpha-Stim SCS is a
Class IIa, Type B medical device. It has
been independently tested by outside agencies in order to provide
assurance of conformity to applicable standards for medical equipment
safety and electromagnetic compliance.
Caution statement for United States: Federal law (USA only)
restricts this device to sale by, or on the order of, a licensed health
care practitioner. Outside the USA it is available world wide without an
order from a health care practitioner but consultation with a qualified health care professional
is recommended for difficult and unresponsive problems or when used with
pharmaceuticals or other therapeutic intervention.
Indications: Alpha-Stim cranial electrotherapy stimulation (CES)
technology is continuously being subjected to rigorous study and
evaluation by the international medical community. Findings to date
indicate that the Alpha-Stim SCS is an effective treatment with broad
applications for a variety of anxiety disorders, or for the short term
relief of the symptoms of anxiety, depression and/or insomnia. In many
cases it is the sole therapeutic method required. As with any
therapeutic intervention, not all people will respond to the Alpha-Stim
SCS. The degree of efficacy will vary with the nature of the problem
being treated and the overall health of the person.
Contraindications: Alpha-Stim SCS may affect the operation of
cardiac pacemakers (particularly demand type pacemakers).
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, and in some cases,
for several hours after treatment. Safety of stimulation has not been
established during pregnancy. There have been isolated reports of blood
pressure being lowered by CES so care should be taken while using the
Alpha-Stim SCS with high blood pressure medication.
Adverse effects: Adverse effects are usually mild and
self-limiting. Adverse effects seen in approximately 4,541 patients in
controlled, open, uncontrolled conditions, and by physician survey and
reasonably associated with the use of CES are dizziness (6 cases,
0.13%), skin irritation/electrode burns (5 cases, 0.11%), and headaches
(9 cases, 0.20%). Prolonged CES treatment at higher than necessary
currents 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. It is recommended that CES be used
at least 3 hours before going to sleep. Paradoxical reactions such as
hyperexcited states, increased anxiety, and
sleep disturbances may occur. If the Alpha-Stim SCS does not control
your anxiety, depression and/or insomnia within 3 weeks, discontinue use
and consult your physician.
Technical details:
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Power Source: |
one 9-volt battery
(included) |
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Current: |
10 to 500 ľA
continuously adjustable |
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Frequency: |
0.5 Hz (pulses per
second) |
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Waveform: |
bipolar asymmetrical
rectangular waves, 50% duty cycle, 0 net current |
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Mechanical: |
height: 10 cm,
width: 7.5 cm, depth: 2.3 cm, weight: 106 gm with battery |
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This material is reproduced with the permission of Electromedical Products International, Inc. © 2006
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