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EPI is ISO Certified
Electromedical Products International, Inc. is an International Standards
Organization (ISO) certified establishment. 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.
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
Federal law (USA) restricts this device to sale by, or on the order of, a licensed health
care practitioner.
Indications
Alpha-Stim
®
M is an effective treatment with broad applications for a variety of
syndromes involving pain, and for the management of 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
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