61 93 556 D3509
D3509
.
201.01.02
.
02
19.09.2008
17
Sirona Dental Systems GmbH
3 System description
Operating Instructions TENEO
Standards/Approvals
3
System description
3.1
Standards/Approvals
Certification
The TENEO
®
treatment center complies with the following standards:
z
IEC 60601-1 (electrical and mechanical safety)
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IEC 60601-1-2 (electromagnetic compatibility)
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IEC 60601-1-4 (software)
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IEC 60601-1-6 (serviceability)
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IEC 60601-2-2 (HF surgery)
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ISO 6875 (Patient chair)
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ISO 9680 (Operating light)
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ISO 11143 (Amalgam separator), see also below
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EN 1717 (Connection to the drinking water system), see also below
Original language: German
This product bears the CE mark in accordance with the provisions of the
Council Directive 93/42/EEC of June 14, 1993 concerning medical devices
(MDD).
The treatment center meets the requirements of the Canadian Standards
Association (CSA) according to CAN/CSA-C22.2 No. 601.1-M90
(AM 1 + AM 2), provided the CSA mark is attached on the type plate.
The amalgam separator achieves a separation efficiency of >98%. It therefore
meets the requirements of the standard ISO 11143 and the German Institute
for Structural Engineering (DIBT). The amalgam separator bears the Ü mark
of the DIBT and the AFNOR mark (of the French Standards Institute).
The treatment center complies with the technical rules and requirements on
safety and hygiene for connection to the public drinking water supply. The unit
is certified according to the requirements of the DVGW (Deutscher Verein für
Gas und Wasser = German Gas and Water Association). The unit thus fulfills
the requirements of EN 1717.
The current approvals are listed on the rating label of the patient chair.
The wireless modules in the wireless foot control and in the treatment center
meet the requirements of the R&TTE directive 1999/5/'EC. Standards:
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EN 60950-1
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EN 301489-1, EN 301489-17, EN 300328
The modules meet the requirements of the Federal Communications
Commission (Part 15 of the FCC Rules).
FCC ID: SIFNANOLOCAVR0108
TENEO
®
is a registered trademark of Sirona Dental Systems GmbH.
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