Regulatory; Certifications; Environmental Statement On The Life Cycle Of The Equipment Or System; Mode Of Operation - AGFA DX-D 600 User Manual

2.7

REGULATORY

2.7.1

CERTIFICATIONS

2.7.2

ENVIRONMENTAL STATEMENT ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM

2.7.3

MODE OF OPERATION

0242F EN 20181218
The DX-D 600 Radiographic Room 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-D 600 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 60601-2-7: DX-D 600 in accordance with
IEC 60601-2-7: 1998.
Statement of Compliance with IEC 60601-2-54: DX-D 600 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: DX-D 600 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 loading, in accordance with

Standard IEC 60601-1:1988.
Permanently Installed Equipment.

DX-D 600
User Manual
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