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Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
Protection degree against electrical
shock
Protection degree against water
penetration
IP68 (intraoral sensor part)
IPX0 (control box)
Mode of operation Continuous operation
Flammable anesthetics
Not suitable for use in situation with
air, oxygen or nitrous oxide
Not suitable for use in oxygen-rich
situation
Both Pluto0001X and Pluto0002X are only one power supply and signal
input and output part, both the power and signal via a USB port to connect to
a PC.
Safety standards reference
battery pack and other accessories.
IEC 60601 1: 2005
+ CORR. 1 (2006) +
CORR. 2 (2007) +
AM1 (2012)
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
EN 60601-1:2006 +
A11:2011 + A1:2013 +
A12:2014
Medical electrical equipment – Part 1: General
requirements for basic safety and essential
performance
ANSI/AAMI
ES60601-1:2005/
(R)2012 + A1:2012 +
C1:2009/(R)2012 +
A2:2010/(R)2012
Medical electrical equipment – Part 1: General
requirements for basic safety and essential
performance
CAN/CSA-C22.2
No.60601-1:14
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
KS C IEC 60601-1 Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
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