iRay Technology Canis014D07, Руководство пользователя

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Regulatory Information
11
Canis014D07 User Manual
This symbol is used to indicate that the product is a medical device. Product label
This symbol is used to represent nonionizing electromagnetic radiation. Product label
This symbol indicates a carrier that contains unique device identifier
information.
Product label
This symbol is used to indicate Federal Communications Commission
certificate.
Product label
2.2 Safety Standards for Medical Equipment
2.2.1 Medical Equipment Classification
Item Classification
Type of protection against
electrical shock
Class I ME equipment, using the medical approved adaptor;
Internally powered ME equipment, using the internal battery
Degree of protection against
electrical shock
Without applied part
Degree of protection against
ingress of water
IPx0
Mode of operation Continous operation
Flammable anesthetics CAN NOT be suitability for use in an OXYGEN RICH ENVIRONMENT
2.2.2 Product Safety Standards
Standard Description
IEC 60601-1:2005 + A1:2012
/EN 60601-1:2006 + A1:2013
Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
ANSI/AAMI ES60601-1:2005
+ A1:2012 + Amendment
2:2010
Medical Electrical Equipment – Part 1: General requirements for safety and
essential performance
CSA CAN/CSA-C22.2 NO.
60601-1:14-2014
Medical Electrical Equipment – Part 1: General requirements for 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 60601-1-3:2008 + A1:2013
/EN 60601-1-3:2008 + A1:2013
Collateral standard: General requirements for radiation protection in
diagnostic equipment.
IEC 60601-1-6:2010 +
A1:2013/EN 60601-1-6:2010 +
A1:2013
Medical electrical equipment -- Part 1-6: General requirements for basic
safety and essential performance -- Collateral standard: Usability