OMS ARCADIA EXT S.T.01/3R ED.0 REV.8 09/2020
18
IMPORTANT
Note:
The device is designed and manufactured in compliance with Directive 93/42/EEC medical
devices (and s) and international safety regulations CEI EN 60601-1 (medical electrical
equipment-General requirements for safety), CEI EN 60601-1-2 (medical electrical equipment –
collateral regulation: electromagnetic compatibility), IEC 80601-2-60 (Medical electrical
equipment: Particular requirements for basic safety and essential performance of dental
equipment), ISO 6875 (patient chairs) , UNI CEI EN ISO 14971 (risk analysis), CEI EN 62304 (ing.
Software), CEI EN 62366 (ing. Usability), CEI EN 60601-1-6 (Usability).
Note:
O.M.S. declines every responsibility to the effects of the safety and the reliability if the
assemblage, the additions, the ritaratures, the changes or reparations are not effected from
technical authorized O.M.S. with instructions and components exclusively furnished from
O.M.S. and if the electric plant of the environment in matter is not conforming to the norms IEC
and/or the instrument is not used in conformity to the use instructions.
Summary of Contents for ARCADIA EXT
Page 1: ...Instructions for use Patient Chair ARCADIA EXT...
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