Dowload Practitioner's
Guide to Using
Alpha-Stim®

 

 

 

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Alpha-Stim® Prescribing Information

Alpha-Stim® devices are sold by or on the order of a licensed healthcare/mental health practitioner (U.S.), including physician, dentist, podiatrist, nurse practitioner, chiropractor, naturopath, psychologist, MCSW, acupuncturist and physical therapist. Please check with your state's licensing board when in doubt.

When ordering an Alpha-Stim® unit you must specify the model to avoid unnecessary delays in dispensing the device to your patient, i.e. "Alpha-Stim® 100”, “Alpha-Stim® SCS” or “Alpha-Stim® PPM” and please state "no substitutions" (please see model comparison below). Please include your degree and license number on the prescription or on the statement of medical necessity. No Rx is required for shipments outside the U.S. but consultations with a qualified healthcare professional are strongly recommended, especially for patients with difficult or unresponsive conditions and for patients taking prescription medications.

Alpha-Stim® prescribing information
Statement of Medical Necessity for Alpha-Stim® purchase or rental

If your clinic does not dispense Alpha-Stim® devices directly to patients at this time, we would be happy to serve your clients. You may send us a medical order directly and we will follow up with the patient. The Rx and patient contact information can be faxed to us using our dedicated fax line (888-684-8414), scanned and sent to us as an email attachment, or mailed to:

Clinical Support
Allevia Health, Inc.
2312 NW Kings Blvd.
Corvallis, OR 97330

Model comparison

 

Alpha-Stim® 100
For treating multiple pain areas, and anxiety, insomnia and depression often associated with chronic pain.

Alpha-Stim® SCS
For treating anxiety, iinsomnia and depression without pain.

Alpha-Stim® PPM
For treating simple pain problems on one or two areas of the body without attendant anxiety, insomnia and depression.

Primary Indications      
.....Pain
 
.....Anxiety
 
.....Insomnia
 
.....Depression
 
Treatment Methods      
.....Probes for Pain
   
.....Electrodes for Pain
 
.....Ear clips for CES
 
Five (5) Year Warranty
Clinical and Technical Support

CE conformity statement for Europe
The Alpha-Stim® 100 and Alpha-Stim® SCS are class IIa, Type B medical devices. They have been independently tested by outside agencies in order to provide assurance of conformity to applicable standards for medical equipment safety and electromagnetic compliance. The Alpha-Stim® PPM is not yet approved for sale in Europe.

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 world wide without a prescription but consultation with a qualified health care professional is recommended for difficult and unresponsive problems or when used in conjunction with pharmaceuticals or other therapeutic intervention.

Indications
Alpha-Stim® 100, Alpha-Stim® SCS, and Alpha-Stim® PPM microcurrent electrical therapy (MET) and 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® 100 and Alpha-Stim® PPM (MET) are effective treatment with broad applications for a variety of syndromes involving pain, or for the short term relief of the symptoms of pain, and the Alpha-Stim® 100 and Alpha-Stim® SCS (CES) are effective treatment with broad applications for the management of anxiety, depression, and/or insomnia, 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. Effective results in pain management have been seen 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® 100, Alpha-Stim® PPM or Alpha-Stim® SCS. 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
The Alpha-Stim® 100, Alpha-Stim® PPM or Alpha-Stim® SCS may affect the operation of cardiac pacemakers (particularly demand type pacemakers). Do not stimulate directly on the eyes, or over the carotid sinus (on the neck beside the larynx).

Precautions
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, and in some cases, for several hours after treatment with the Alpha-Stim® 100 or Alpha-Stim® SCS (CES). 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 or in cases where people may overuse pain-controlled areas. 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 or Alpha-Stim® SCS with high blood pressure medication.

Adverse effects (Alpha-Stim® 100 and Alpha-Stim® SCS)
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 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, but are rare.

 

 

 

 

 

 

 


 

 
 

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