Standards And Regulations; Operating Principles - VATECH A9 Handbuch

1. Imaging System Overview
1.4

Standards and Regulations

Standards
vatech A9 (PHT-30CSS) is designed and developed to comply with the following
international standards and regulations:
▪
MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT AS TO
ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012),
CAN/CSA-C22.2 No. 60601-1 (2014), IEC 60601-1-3 (2008), IEC 60601-2-63
(2012)
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21 CFR 1020.30, 31, 33
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NEMA Standard publication PS 3.1-3.18
Classifications (IEC 60601-1 6.1)
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The degree of protection against water ingress: Ordinary Equipment: IPX0
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The degree of protection against electric shock: Class 1 equipment, Type B
Applied Parts
1.5

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 an 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.
4
This is Class IIb equipment and obtained CE marking in
April 2007 for regulations compliance by the revised
European Union's MDD (Medical Devices Directive)
93/42 EEC.
UL symbol grants this equipment compliance with the
CAN/CSA C22.2 No.601.1.
vatech A9 (PHT-30CSS) User Manual