Regulatory Information; Certifications; Environmental Statement On The Life Cycle Of The Equipment Or System; Mode Of Operation - Konica Minolta mKDR Xpress Operation

Mobile X-ray Unit
Operation
2.7

REGULATORY INFORMATION

2.7.1

CERTIFICATIONS

.
Note
2.7.2

ENVIRONMENTAL STATEMENT ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM

2.7.3

MODE OF OPERATION

20
The Mobile X-Ray Unit covered by this Operation Manual complies with the
following certifications:
Statement of Compliance with IEC 60601-1-3: Mobile X-Ray Unit with

radiation protection in accordance with IEC 60601-1-3: 1994 and
IEC 60601-1-3: 2008 and IEC 60601-1-3:2008+AMD1:2013 .
Statement of Compliance with IEC 60601-2-54: Mobile X-Ray Unit for

Radiography
IEC 60601-2-54:2009 and IEC60601-2-54:2009+AMD1:2015.
Statement of Compliance with 21CFR Subchapter J: This Mobile X-Ray

Unit conforms to DHHS radiation Standards of 21CFR subchapter J as
of the date of manufacture.
Mobile X-Ray Unit model or type references are stated at the
back cover of this document.
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 IEC 60601-1:2005+AMD1:2012.
and/or Radioscopy in accordance with
OM-0481R1