CE conformity statement for Europe:
The Alpha-Stim® PPM is a Class IIa, Type B medical device. It has been independently tested by outside agencies in order 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 world wide without a prescription but consultation with a qualified health care professional is recommended for difficult and unresponsive problems.
Indications: Alpha-Stim® PPM technology is continuously being subjected to rigorous study and evaluation by the international medical community. Findings
to date indicate that the Alpha-Stim® PPM is an effective treatment with broad applications for a variety of syndromes involving acute, chronic, and post operative
pain. 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® PPM. 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.
The Alpha-Stim® PPM 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).
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.
Adverse effects are usually mild and self-limiting. Adverse effects from approximately 4,541 patients participating in controlled, open, uncontrolled research, and by physician survey are skin irritation/electrode burns (5 cases, 0.11%), and headaches (9 cases, 0.20%).
If the Alpha-Stim® PPM does not control your pain within 3 weeks, consult your physician.
two AAA 1.5-volt batteries (included)
10 to 600 µA continuously adjustable
0.5 Hz (pulses per second)
bipolar asymmetrical rectangular waves, 50% duty cycle, 0 net current
height: 8 cm, width: 5.8 cm, depth: 2 cm, weight: 82 gm with batteries
LCD timer with low and flat battery warning symbols