Vatech Premium PAX-i3D, Руководство пользователя

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4. Imaging System Overview
20 PaX-i3D Green Premium™ User Manual
Auto Ceph option is available under DENTAL CT (FOV: 21x19) and
ENT CT (FOV: 21x19) modality.
* When selected, Auto Pano and/or Auto Ceph image is automatically
acquired and can be seen on the
EzDent-i
Viewer.
4.3 Standards and Regulations
Standards
PaX-i3D Green Premium™ was designed and developed to comply with the following
international standards and regulations:

IEC/EN 60601-1(3rd), UL 60601-1(1st), IEC/EN 60601-1-3, IEC 60601-2-63

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 UL certification mark in
accordance with UL 60601-1/CAN/CSA C22.2
No.601.1 regulations.
Classifications (IEC 60601-1 6.1)

Degree of protection against water ingress: Ordinary Equipment: IPX0

Degree of protection against electric shock: Class 1 equipment, Type B Applied
Parts: Headrest, Chinrests and Bites