Indication and Risk Information

Electromedical Products International, Inc. is an International Standards Organization (ISO) certified organization. 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. Please see below for information related to indication and risk for Alpha-Stim^® technologies.

Indications for Alpha-Stim AID and Alpha-Stim M

Alpha-Stim AID is a safe, drug-free option designed to provide anxiety and insomnia relief and management. It is FDA cleared for anxiety and insomnia, with approval for depression outside of the United States.

Alpha-Stim M is an effective treatment with broad applications for a variety of syndromes involving pain, as well as the treatment of anxiety, and 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. 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.

Electromagnetic interference

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.

Contraindications

Use of an Alpha-Stim device is contraindicated with implanted pacemakers or implanted or wearable defibrillators.

Warnings and Precautions

Safety of stimulation has not been established during pregnancy.
Do not stimulate directly on the eyes or press the probes over the carotid sinus (on the neck near the larynx). Application of the electrodes near the thorax may increase the risk of cardiac fibrillation.
Potential hazard from simultaneous connection of a patient to a high frequency surgical medical equipment and stimulator may result in burns and possible damage to the stimulator.
Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy medical equipment may produce instability in the stimulator output.
Modification of your Alpha-Stim device or accessories is not allowed, it could result in injury.
Do not place Alpha-Stim in direct contact with lint, dust, light (including sunlight). – For external use only. Small parts, keep out of reach of children, avoid inhalation or swallowing.
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.
Do not plug leadwires into wall sockets or line cord receptacles under any circumstances.
Doing so could result in severe shock or burns whether the leadwires are attached to the stimulator or not.
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 worldwide without a prescription but consultation with a qualified health care professional is recommended for difficult and unresponsive problems or when used with pharmaceuticals or other therapeutic intervention.

Adverse effects

Adverse effects are usually rare (occurring less than 1% of the time), mild, and self-limiting.

dizziness
skin irritation/electrode burns
headaches