Xltek
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EMU40EX™ User and Service Manual
8
EMU40EX Safety and Standards Conformity
Standards of Compliance and Normative References
Multichannel Sleep/EEG Amplifier System, Model EMU40EX, detachable cord connected, portable
115/230Vac, 50/60Hz, 30W.
1. Type of protection against electric shock: Class I
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 anaesthetic mixture with air or
with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous oxide.
5. Mode of operation: Continuous
6. Environmental Conditions: Normal: 10-40°C, 30-75% rH, 700-1060hPa
The EMU40EX 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 + C1:2006 and
C2:2007, Third Edition
CENELEC EN 60601-1:2006 + A1:2013
Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-6:2010, Edition 3.0
Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential performance –
Collateral standard: Usability
IEC 62366:2007, Edition 1.0
Medical devices – Application of usability engineering to
medical devices
IEC 60601-2-26:2012, Edition 3
CENELEC EN 60601-2-26L2003,
Edition 2
Medical electrical equipment – Part 2-26: Particular
requirements for the safety of electroencephalographs
EN ISO 80601-2-61:2011, Edition 1
Medical electrical equipment – Part 2-61: Particular
requirements for basic safety and essential performance
of pulse oximeter equipment
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