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Technical Specifications for the Alpha-Stim 100

Timer Settings: Probe (10 seconds on alternating with 2 seconds off), 10, 20, 60 minutes, and continuous.

Current: 10 to 600 µA continuously adjustable.

Frequency: 0.5, 1.5, or 100 Hz (pulses per second).

Waveform: Bipolar asymmetric rectangular waves, 50% duty cycle, 0 net current (see graphic depiction).

Mechanical: Height 13.5cm, width 6.4cm, depth 3.3cm including belt clip. Weight 156gm with battery.

CE conformity statement: the Alpha-Stim® 100 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.

Indications: Findings to date indicate that the Alpha-Stim® 100 is an effective treatment with broad applications for a variety of syndromes involving pain, and for the management of anxiety, depression, and/or insomnia, or for the short term relief of the symptoms of pain, anxiety, depression and/or insomnia. In many cases it is the sole therapeutic method required. Effective results in pain management have been seen during and/or subsequent to stimulation over effected body parts, adjacent areas, and areas distant from those in pain. As with any therapeutic intervention, not all people will respond to the device. the degree of efficacy will vary with the nature of the problem being treated, the overall health of the person, and with the method of treatment.

Contraindications: May effect the operation of cardiac pacemakers (particularly demand type pacemakers).

Precautions: 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. 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® 100 with high blood pressure medication.

Adverse Effects: Adverse effects are usually mild and self-limiting. Adverse effects seen in 20 out of 4,058 patients in controlled, open, uncontrolled conditions, and by physician survey and reasonably associated with the use of CES are dizziness (6 cases, 0.15%), skin irritation/electrode burns (5 cases, 0.12%), and headaches (9 cases, 0.22%). Prolonged CES treatment at higher than necessary currents may cause dizziness or nausea that can last from 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.

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