EPI is ISO Certified
Electromedical Products International, Inc. is an International Standards Organization (ISO) certified establishment. ISO is an International organization working with some 140 countries and the United Nations to maintain standards for all applications of technology for global industry. Requirements for the medical device industry relate to design controls, risk management, environmental controls, special processes (e.g. software validation), traceability, record retention, and regulatory actions such as vigilance.
This equipment has been independently tested by outside agencies and found to comply with the limits of Comité International Spécial des Perturbations Radioélectriques (CISPR). These limits are designed to provide reasonable protection against harmful interferences in a residential or clinical environment. However, it is still possible that interference could occur in a particular environment. In case interference does occur, increase the distance between this device and the equipment it interferes with. Consult Electromedical Products International, Inc. if the problem persists.
CE Conformity Statement for Europe
The Alpha-Stim® M is a Class IIa, Type BF medical device. It has been independently tested by outside agencies 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 of the USA it is available worldwide without a prescription but consultation with a qualified health care practitioner is recommended.
Alpha-Stim® M is an effective treatment with broad applications for a variety of syndromes involving pain, and for the management of insomnia, or for the short term relief of symptoms associated with these indications. In many cases, it is the sole therapeutic method required. Effective results in pain management have been achieved during and/or subsequent to stimulation over affected body parts, adjacent areas, and areas distant from those in pain. As with any therapeutic intervention, not all people will respond to the Alpha-Stim® M. 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. As much as a one month initial trial may be required to see significant reductions in symptoms.
Alpha-Stim 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).
For external use only. Do not allow children to use or handle these devices without adult supervision. Do not operate potentially dangerous machinery or vehicles during treatment, and in some cases for several hours after treatment. Caution is advised in cases where other forms of analgesia (pain control) would not be used; such as to retain pain for diagnosis or in cases where people may overuse pain-controlled areas. Safety of stimulation has not been established during pregnancy.
Adverse effects are usually mild and self-limiting. Adverse effects from data on approximately 8,800 patients participating in 144 controlled studies, open clinical trials, and uncontrolled conditions, and by physician survey and reasonably associated with the use of CES and MET 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. Paradoxical reactions such as increased anxiety, and sleep disturbances may occur, but are rare.
If Alpha-Stim does not begin to control your pain or insomnia within one month, consult your healthcare practitioner, authorized Alpha-Stim distributor, or EPI for advice.