Vatech A9, Руководство пользователя, Страница: 30 / 196

4. Imaging System Overview
30 vatech A9 (Model name: PHT-30CSS) User Manual
4.4 Standards and Regulations
Standards
vatech A9 (Model name: 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, AMD1:2013, IEC
60601-2-63:2012, AMD1:2017

21 CFR 1020.30, 31, 33

NEMA Standard publication PS 3.1-3.18
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.
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, AMD1:2013, IEC 60601-2-63:2012,
AMD1:2017
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 (Chinrest, Bite and cover, Nasal Positioner and cover, Ear Rod and
cap, Carpus Plate)
4.5 Operating Principles
X-ray is emitted when a high voltage is supplied to the 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-rays
continuously and rotates on the human tooth at different angles.
Images are acquired, computed, and recompiled to reproduce 2D or 3D images.