הרשמה   | כניסה

לייעוץ: 1-700-70-00-70

טיפול
בדיכאון
  טיפול בחרדה
ומתח נפשי
  טיפול
בהפרעות שינה
  טיפול
בכאבים
יצירת קשר
חדשות ומבזקים
חנות און ליין
Prescribing Information
 

CE Conformity Statement for Europe: The Alpha-Stim® is a Class IIa, Type B 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: Outside of the USA, this device 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® 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® 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 Alpha-Stim®. The degree  of efficacy will vary with the nature of the problem being treated and the overall health of the person and with the method of the treatment.

Contraindications: Alpha-Stim® may affect the operation of cardiac pacemakers (particularly demand type pacemakers). Do not stimulate directly on the eyes, or over the carotid sinus (upper side of neck, below the ear and behind the jaw).

Precautions: For external use only. Do not allow children to use or handle this device without adult supervision. Do not operate potentially dangerous machinery or vehicles during, 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 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® with high blood pressure medication.

Adverse Effects: 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 for 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.

If the Alpha-Stim® does not control your pain, anxiety, depression and/or insomnia within 3 weeks, consult with Alpha-Med at Tel: 1-700-70-00-70 or your physician.

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Alpha-Med כתובת למשלוח דואר: זלמן שז''ר 16 נתניה, 42493 כתובת המשרד: שד' גיבורי ישראל 5 א', א.ת. פולג, נתניה טלפון: 1-700-70-00-70 פקס: 057-7943701 052-5677240
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