Vatech GREEN SMART - Standards and Regulations; Operating Principles

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.