Unit Description; Standards/Approvals - Sirona Sinius CS Operating Instructions Manual

3 Unit description

3.1 Standards/Approvals

0123
SIRONA
Dental Systems
GmbH
64625 Bensheim
Fabrikstrasse 31
Z-64.1-14
22
3
Unit description
Unit description
3.1
Standards/Approvals
Compliance with standards, without HF surgery Standards/Approvals
The SINIUS / SINIUS CS
standards, among others:
● IEC 60601-1 (electrical and mechanical safety plus software
reliability)
● IEC 60601-1-2 (electromagnetic compatibility)
● IEC 60601-1-6 (serviceability)
● ISO 6875 (Patient chair)
● ISO 7494-1 (Dental treatment devices)
● ISO 7494-2 (dental treatment units, water and air supply)
● ISO 9680 (Operating light)
● ISO 11143 (amalgam separator), see also below
(if amalgam separator option is present)
● EN 1717 (connection to the drinking water system), see also below and
the chapter titled "Connection to the drinking water system" [ → 16]
Original language: German
This product bears the CE mark in accordance with the provisions of
CE mark of the BHE
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
The amalgam separator achieves a separation efficiency of > 95%. The
Ü mark of the amalgam separator
unit thus fulfills the requirements of ISO 11143.
Separating procedure type 1: Centrifugal system
The amalgam separator is approved by the German Institute for
Structural Engineering (DIBT) and by the French International
Organization for Standardization (AFNOR).
When equipped with a disinfection system, the treatment center complies
German Gas and Water Association (DVGW) certified connection for Germany
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). It is intrinsically safe
in accordance with worksheet W540. The unit also meets, therefore, the
requirements of standard EN 1717; see also the chapter entitled
"Connection to the public drinking water system" [ → 16].
This unit meets the requirements of BELGAQUA and may therefore be
BELG AQUA for Belgium
connected to the public drinking water supply in Belgium.
Sirona Dental Systems GmbH
Operating Instructions SINIUS / SINIUS CS
®
treatment center complies with the following
D3561.201.01.03.02 05.2012
63 22 726 D3561