AGFA DX-D 300, User Manual, Page: 27 / 104

DX-D 300 U-Arm
User Manual
0171F EN 20181009
19
2.7 REGULATORY INFORMATION
2.7.1 CERTIFICATIONS
The DX- D300 U-Arm 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- D300 U-Arm
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- D300 U-Arm in
accordance with IEC 60601--2--7: 1998.
Statement of Compliance with IEC 60601--2--54: DX- D300 U-Arm 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- D300 U-Arm
conforms to DHHS radiation Standards of 21CFR subchapter J as of the date
of manufacture.
2.7.2 ENVIRONMENTAL STATEMENT ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM
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.
2.7.3 MODE OF OPERATION

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.