Unit Description; Standards/Approvals; Sirona Dental Systems Gmbh - Sirona teneo Operating Instructions Manual

Sirona Dental Systems GmbH

Operating Instructions (USA) TENEO
0123
C US
SIRONA
Dental Systems
GmbH
64625 Bensheim
Fabrikstrasse 31
Z-64.1-24
65 48 510 D3509
D3509.201.03.03.23 10.2016
3

Unit description

3.1

Standards/Approvals

®
The TENEO dental treatment unit complies with the following standards:
Compliance with standards, without HF surgery
● IEC 60601-1 (electrical, mechanical, and software safety)
● IEC 60601-1-2 (electromagnetic compatibility)
● IEC 60601-1-6 / IEC 62366 (usability)
● IEC 62304 (software process)
● ISO 6875 (patient chair)
● ISO 7494-1 (dental treatment units)
● ISO 7494-2 (dental treatment units, water and air supply)
● ISO 9680 (operating light)
● ISO 11143 (amalgam separator), see also below
(provided amalgam separator option is available)
● EN 1717 (connection to the drinking water system), see also below
and chapter "Connection to the public drinking water supply" [ → 17]
Original language of the present document:German
This product bears the CE marking in accordance with the provisions of
CE mark, general
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
The dental treatment unit complies with the requirements of the RoHS
RoHS Directive
Directive 2011/65/EU.
The dental treatment unit meets the requirements of the Canadian
CSA for Canada
Standards Association (CSA) according to CAN/CSA-C22.2 No. 60601-1
and AAMI/ANSI ES 60601-1.
The amalgam separator achieves a separation efficiency of >98%. The
Ü and AFNOR marks of the amalgam separator, also for France
requirements of the ISO11143 standard are thereby fulfilled.
Type 1 separation process: Centrifugal system
The amalgam separator is approved by the German Institute for
Structural Engineering (DIBT) and by the AFNOR (France).
The dental treatment unit complies with the technical regulations and
German Gas and Water Association (DVGW) for Germany
requirements on safety and hygiene for connection to the public drinking
water supply. The unit is certified according to the requirements of the
DVGW (German Gas and Water Association). It is intrinsically safe in
accordance with worksheet W540. The unit thus fulfills the requirements
of EN 1717, see also the chapter entitled "Connection to the public
drinking water supply" [ → 17].
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3.1 Standards/Approvals
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