Fluke Biomedical Esa601 Electrical Safety Analyser Medical Equipment Tester Unit
FLUKE ESA601 ELECTRICAL SAFETY ANALYSER TESTER. The Fluke ESA601 Electrical Safety Analyzer is a full-featured, low-cost, compact analyzer, designed to verify the electrical safety of medical devices. The ESA601 satisfies international (IEC 601-1, VDE) and domestic (ANSI/AAMI ES1) electrical-safety standards. The integrated ANSI/AAMI ES1 and IEC 601-1 patient loads are easily selectable, utilizing a slide switch. It is the buyers responsibility to have the item professionally tested, calibrated or serviced before clinical use on humans or animals. Regardless of the origin of the equipment, documentation provided or identification appearing upon the equipment, the equipment described and offered here is in no way certified for, recommended for, or offered for any specific use. This product is in compliance with the essential requirements of Council Directive 93/42/EEC Medical Device Directive, as amended by Council Directive 2007/47/EC, class IIa. The sale of this item may be subject to regulation by the U. Food and Drug Administration and state and local regulatory agencies.