Indication and Risk Information
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.
Indications
The Alpha-Stim AID is a precision medical device used for cranial electrotherapy stimulation for the treatment of anxiety and insomnia.
The Alpha-Stim M is a precision medical device and is an effective treatment with broad applications for a variety of syndromes involving pain, and for the management 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 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.
CES for Insomnia and Anxiety
The historical indications for CES devices have mentioned “anxiety” and “insomnia,” which are umbrella terms that encompass a variety of specific diagnoses, severities, etc. CES devices have been found to collectively demonstrate a class effect for treating “anxiety” and/or “insomnia.” Evidence specific to the Alpha-Stim® technology can be found in the “Clinical Literature Summary on Alpha-Stim® for Anxiety and Insomnia” section of the Owner’s Manual, which details the populations for which EPI has evidence. Individuals using this device should work with the prescribing healthcare practitioner to determine the best treatment settings to use.
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.
- This device is intended to be used in individuals who are 18 years of age or older.
- Brain development continues beyond 18 years of age. The long-term effects of electrical stimulation from this device on the brain has not been studied.
- 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.
- Patients should be monitored by their physician for signs of worsening.
- If a patient experiences headaches while using the device, they should consult their physician prior to continued use of the device.
- Caution Statement for United States: Federal law (USA only) restricts this device to sale by, or on the order of a licensed healthcare practitioner. Outside the USA it is available worldwide without a prescription but consultation with a qualified healthcare professional is recommended for difficult and unresponsive problems or when used with pharmaceuticals or other therapeutic intervention.
Contraindications
Use of an Alpha-Stim device is contraindicated with implanted pacemakers or implanted or wearable defibrillators.
Adverse effects
Adverse effects are usually rare (occurring less than 1% of the time), mild, and self-limiting.
- Dizziness
- Skin irritation/electrode burns
- Headaches
Reporting Device Issues
Please contact EPI if you have any concerns with the device: Call EPI at 1-800-367-7246 or email alpha-stim@epii.com. If you are located outside of the US, please call +1-940-328-0788.
You may also report any adverse events to the FDA using the following information:
MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your healthcare provider can provide clinical information based on your medical record that can help FDA evaluate your report.
However, we understand that for a variety of reasons, you may not wish to have the form filled out by your healthcare provider, or your healthcare provider may choose not to complete the form. Your healthcare provider is not required to report the information. In these situations, you may complete the Online Reporting Form yourself.
You will receive an acknowledgement from FDA when your report is received. Reports are reviewed by FDA staff. You will be personally contacted only if we need additional information.
Submitting adverse event reports to FDA
Use one of the methods below to submit voluntary adverse event reports to the FDA:
Report Online at: www.accessdata.fda.gov/scripts/medwatch/ index.cfm?action=reporting.home
Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission. For help filling out the form, see MedWatchLearn. The form is available at: www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting
Call FDA at 1-800-FDA-1088 to report by telephone.
Reporting Form FDA 3500 is commonly used by health professionals. The form is available at: www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting
CE Conformity Statement for Europe
The Alpha-Stim AID, and Alpha-Stim M are Class IIa, Type BF medical devices. Both of which have been independently tested by outside agencies to provide assurance of conformity to applicable standards for medical equipment safety and electromagnetic compliance.
Indications
The Alpha-Stim AID is a precision medical device used for cranial electrotherapy stimulation in adults 22 years and above for the treatment of anxiety, insomnia, depression and pain.
The Alpha-Stim M is a precision medical device used for cranial electrotherapy stimulation in adults 22 years and above for the treatment of anxiety, insomnia, depression and pain, AND transcutaneous electric nerve stimulation for management of acute, chronic and post-traumatic pain. It is an effective treatment for anxiety, insomnia, depression and pain using Earclip Electrodes, Smart Probes and AS-Trodes. 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.
Warnings and Precautions
- Safety of stimulation has not been established during pregnancy.
- Do not stimulate directly on the eyes or press the Smart 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 healthcare practitioner. Outside the USA it is available worldwide without a prescription but consultation with a qualified healthcare professional is recommended for difficult and unresponsive problem
Contraindications
Use of an Alpha-Stim device is contraindicated with implanted pacemakers or implanted or wearable defibrillators.
Adverse effects
Adverse effects are usually rare (occurring less than 1% of the time), mild, and self-limiting.
- Dizziness
- Skin irritation/electrode burns
- Headaches
Indications
The Alpha-Stim AID is a precision medical device used for cranial electrotherapy stimulation in adults 22 years and above for the treatment of anxiety, insomnia, depression, and pain.
The Alpha-Stim M is a precision medical device used for cranial electrotherapy stimulation in adults 22 years and above for the treatment of anxiety, insomnia, depression and pain, and transcutaneous electric nerve stimulation for management of acute, chronic and post-traumatic pain. It is an effective treatment for anxiety, insomnia, depression and pain using Earclip Electrodes, Smart Probes and AS-Trodes. 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.
Warnings and Precautions
- Safety of stimulation has not been established during pregnancy.
- Do not stimulate directly on the eyes or press the Smart 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 healthcare practitioner. Outside the USA it is available worldwide without a prescription but consultation with a qualified healthcare professional is recommended for difficult and unresponsive problem
Contraindications
Use of an Alpha-Stim device is contraindicated with implanted pacemakers or implanted or wearable defibrillators.
Adverse effects
Adverse effects are usually rare (occurring less than 1% of the time), mild, and self-limiting.
- Dizziness
- Skin irritation/electrode burns
- Headaches
