User and Service Manual XLTEK EEG32U Amplifier
9
EEG32U Amplifier Safety and Standards Conformity
Standards of Compliance and Normative References
32 Channel Electroencephalograph (EEG) Amplifier; model EEG32U; rated 5Vdc,0.2A
1. Type of protection against electric shock: Class II
2. Degree of protection against electric shock: Type BF
3. Degree of protection against ingress of water: IPX0
4. Degree of safety of application in the presence of a flammable anesthetic mixture with air or with
oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
5. Mode of operation: Continuous
6. Environmental Conditions : Normal : 10-40° C, 30-75% rH, 700-1060 hPa
The EEG32U amplifier and its accessories have been designed to comply with the following national and
international standards.
Table 1 – Safety Standard of Compliance and Normative References
CAN /CSA-C22.2 No. 60601-1: 08(R2013) +
C2:2011
ANSI/AAMI ES60601-1:2005/(R)2012 +
C1:2009/(R)2012 and A2:2010/(R)2012
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
IEC 60601-1-6:2010/AMD1:2013 Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability
IEC 62366-1:2015
IEC 62366-1:2015/AMD1:2020
Medical devices – Application of usability engineering to medical
devices
Medical devices - Part 1: Application of usability engineering to medical
devices Consolidated version
IEC 60601-2-26:2012
EN 60601-2-26:2003
Medical Electrical Equipment - Part 2-26: Particular Requirements for
the basic safety and essential performance of electroencephalographs
Medical electrical equipment – Part 2-26: Particular requirements for
the safety of electroencephalographs
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