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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
®
AID 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.
Indications
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, and depression.
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.
PRESCRIBING INFORMATION
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