Vatech A9 User Manual

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.

Vatech A9 Specifications

General

Brand	Vatech
Model	A9
Category	Medical Equipment
Language	English