User's Manual

Regulatory Information
KONICA MINOLTA,
INC..……………..…………………………………………………………………………………………………
……………….………..
80
5. Regulatory Information
5.1. Medical equipment safety standards
Medical equipment classification
Type of protection against electrical shock
External electrical power source equipment Class I
Equipment (medical approved adaptor)
Internal electrical power source equipment (battery)
Degree of protection against electrical shock Type-B applied part
Degree of protection against ingress of water IPX1
Mode of operation Continuous operation
Flammable anesthetics
Not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous
oxide
Not suitable for use in the oxygen rich environment
Product safety standards
MDD (93/42/EEC) Medical Device Directive
ISO 13485:2016
Medical devices -- Quality management systems --
Requirements for regulatory purposes
IEC 60601-1:2005/AMD1:2012
Medical electrical equipment -- Part 1: General requirements
for basic safety and essential performance
IEC 60601-1-2:2014/EN60601-
1-2:2015
Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance – Collateral
standard: Electromagnetic disturbances – Requirements and
tests
IEC 60601-2-54:2015/EN
60601-2-54:2015
Medical electrical equipment -- Part 2-54: Particular
requirements for the basic safety and essential performance of
X ray equipment for radiography and radioscopy
IEC 62133:2012
Secondary cells and batteries containing alkaline or other non-
acid electrolytes – Safety requirements for portable sealed
secondary cells, and for batteries made from them, for use in
portable applications
IEC 62220-1:2003
EN 62220-1:2004
Medical electrical equipment - Characteristics of digital X-ray
imaging devices - Part 1: Determination of the detective
quantum efficiency
IEC 62304:2006/AMD1:2015 Medical device software - Software life-cycle processes
IEC 62366-1:2015/IEC
62366:2007/EN 62366:2008
Medical devices –part 1: Application of usability engineering
to medical devices
IEC 60601-1-6:2010+A1:2013
Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral standard:
Usability
EN ISO14971: 2012
Medical device – Application of risk management to medical
devices
ANSI/AAMI ES60601-
1:2005/(R)2012+A1:2012+C1:2
Medical electrical equipment - Part 1: General requirements for
b
asic safety and essential
p
erformance (IEC 60601-1:2005,