DUKE EASY S.T.01/3AW Rev.0 01/2017
11
IMPORTANT NOTE
The devices, in the models foreseen and indicated in this document, are designed and built in compliance
with directive 93/42/EEC "Medical Devices" (as amended) and international safety standards IEC EN
60601-1 (Medical Electrical Equipment - General Requirements for Safety), IEC EN 60601-1-2 (Medical
Electrical Equipment - Collateral standard: Electromagnetic Compatibility), IEC 80601-2-60 (Medical
electrical equipment: Particular requirements for basic safety and essential performance of dental
equipment), ISO 6875:2011 (dental chairs), ISO 7494-1:2011 (dental units)
, UNI CEI EN ISO 14971:2009 (risk analysis), CEI EN 62304:2006 (ing. Software), CEI EN 62366:2008
(ing. Usability), CEI EN 60601-1-6:2011 (usability).
O.M.S. declines any and all responsibility for equipment safety and reliability in the following cases: if
installation, additions, re-calibration, modifications or changes are not performed by O.M.S. authorised
technicians following the instructions and using the components supplied by O.M.S. exclusively; if the
electric system installed in the workplace does not comply with IEC standards; and/or if the equipment
is not used according to the operating instructions.
NAMEPLATE DATA
An identification plate is affixed to the equipment indicating general device data.
A.
Device model
B.
Rated voltage and nature of current (alternating
)
C.
Rated frequency
D.
Rated current
E.
Rated power
F.
Device serial n°
G.
Manufacturer
H.
Cooling fluid temperature
I.
WEEE symbol
J.
Applied part Type B
K.
Certification markings: Medical device directive 93/42/EEC and subsequent amendments
L.
Mandatory, see enclosed documentation
M.
Follow operating instructions
3.
TECHNICAL INSTRUCTIONS FOR INSTALLATION
PACKAGING
The unit is shipped in a box containing instructions accessory box, S.T. 01/3, lamp *, arm lamp *, * suction,
fixing screws. (*)Present only in case of a specific request at the order.
