Vatech GREEN SMART, Руководство пользователя

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4. Imaging System Overview
20 Green Smart User Manual
4.3 Standards and Regulations
Standards
Green Smart is designed and developed to comply with the following international
standards and regulations:

IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-63

CAN/CSA-C22.2 No. 60601-1:14, CAN/CSA-C22.2 No. 60601-1-3:09, CAN/CSA-
C22.2 No. 60601-1-6:11, CAN/CSA-C22.2 No. 60601-2-63:15, CAN/CSA-IEC
62366:15

ANSI/AAMI ES60601-1:2005 / (R)2012, AND A1:2012, A2:2010 / (R)2012
(Consolidated text - edition 3.1)

21 CFR 1020.30, 31, 33

NEMA Standard publication PS 3.1-3.18, 2008
This is Class IIb equipment and obtained CE marking in
April 2007 for regulations compliance in accordance with
the revised European Union’s MDD (Medical Devices
Directive) 93/42 EEC.
This equipment received the CSA certification mark in
accordance with CAN/CSA C22.2 No.601.1 regulations.
Classifications (IEC 60601-1 6.1)

The degree of protection against water ingress: Ordinary Equipment: IPX0

The degree of protection against electric shock: Class 1 equipment, Type B Applied
Parts: Temple Supports, Chinrests, and Bites.
4.4 Operating Principles
X-ray is emitted when a high voltage is supplied to X-ray tube assembly which frees
electrons from the cathode.
They hit anode to produce X-ray. The machine acquires images by emitting X-ray
continuously and rotates on the human tooth at different angles.
Images are acquired, computed and recompiled to reproduce 2D or 3D images.