65 67 510 D3642
D3642
.
201.01.03
.
02 01.2018
13
Dentsply Sirona
3 Unit description
Operating Instructions LEDview Plus
3.1 Standards/Approvals
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3
Unit description
3.1
Standards/Approvals
The LEDview Plus operating light and the ceiling model with LEDview
Plus comply with the following standards (the list below is not exhaustive):
● IEC 60601-1 (Electrical and Mechanical Safety)
● IEC 60601-1-2 (Electromagnetic Compatibility)
● IEC 60601-1-6 / IEC 62366 (Usability)
● IEC 62304 (Software Process)
● ISO 9680 (Operating Light)
● IEC 62471 (Photobiological Safety of Lamps and Lamp Systems)
● ISO 17664 (Sterilization of Medical Products)
The operating light and ceiling model with LEDview Plus bear the CE
mark in compliance with the provisions of Council Directive 93/42/EEC of
June 14, 1993 concerning medical devices.
Note: The Heliodent Plus X-ray tube assembly (category IIb) bears a
separate CE mark with the no. of the notified body (0123). This CE mark
is affixed to the wall adapter.
The operating light and ceiling model fulfill the requirements of the
Directive on the Restriction of Hazardous Substances, 2011/65/EU.
This LEDview Plus operating light has been tested by the VDE Testing
and Certification Institute for compliance with the standards.
This ceiling model with LEDview Plus has been tested by the VDE Testing
and Certification Institute for compliance with the standards.
The operating light and ceiling model meet the requirements in
accordance with CAN/CSA- C22.2 No. 60601-1 and AAMI/ANSI ES
60601-1.
LEDview
®
is a registered trademark of Sirona Dental Systems GmbH.
