Regulatory Information; Certifications; Environmental Statement On The Life Cycle Of The Equipment Or System; Mode Of Operation - AGFA DX-D 100 User Manual

DX-D 100 Mobile X-ray Unit
User Manual
2.7

REGULATORY INFORMATION

2.7.1

CERTIFICATIONS

2.7.2

ENVIRONMENTAL STATEMENT ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM

2.7.3

MODE OF OPERATION

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The DX-D 100 Mobile X-ray Unit 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/EEC concerning
Medical Devices.
Statement of Compliance with IEC 60601-1-3: DX-D 100 Mobile X-ray Unit
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-D 100 Mobile X-ray Unit
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-D 100 Mobile
X-ray Unit 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 its authorized representative 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 with intermittent loading, in accordance with

Standard IEC 60601--1:1988.
Continuous operation, in accordance with Standard IEC 60601-1:2005

and IEC60601-1:2005+AMD1:2012.
0188K EN 20201116