Regulatory Information; Certifications; Environmental Statement On The Cycle Of The Equipment Or System; Mode Of Operation - AGFA DX-D 400 User Manual

DX-D 400
User Manual
2.7

REGULATORY INFORMATION

2.7.1

CERTIFICATIONS

2.7.2

ENVIRONMENTAL STATEMENT ON THE CYCLE OF THE EQUIPMENT OR SYSTEM

2.7.3

MODE OF OPERATION

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The DX- D400 covered by this Operation Manual is authorized to be marked
with CE MARKING in accordance with the provisions of the Council Directive
93 / 42 / EEC as amended by 2007/47/EC concerning Medical Devices.
Statement of Compliance with IEC 60601--1--3: DX- D400 with radiation
protection in accordance with IEC 60601-1-3:1994, IEC 60601-1-3:2008 and
IEC 60601-1-3:2008+AMD1:2013.
Statement of Compliance with IEC 60601--2--54: DX- D400 for Radiography
and/or Radioscopy in accordance with IEC 60601-2-54:2009 and IEC
60601-2-54:2009+AMD1:2015.
Statement of Compliance with 21CFR Subchapter J: This DX- D400 conforms
to DHHS radiation Standards of 21CFR subchapter J as of the date of
manufacture.
This equipment or system contains environmentally dangerous components
and materials (such as PCBs, electronic components, used dielectric oil, lead,
batteries etc.) which, once the life-cycle of the equipment or system comes to
an end, becomes dangerous and need to be considered as harmful waste
according to the international, domestic and local regulations.
The manufacturer recommends to contact an authorized representative of the
manufacturer or an authorized waste management company once the life-cycle
of the equipment or system comes to an end to remove this equipment or
system.
Continuous operation, in accordance with Standard IEC 60601--1:2005

and IEC 60601--1:2005+AMD1:2012.
Continuous operation with intermittent load, in accordance with Standard

IEC 60601--1:1998.
Permanently Installed Equipment.

0232F EN 20191213