natus Xltek EMU40EX, Руководство пользователя и обслуживания

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EMU40EX™ User and Service Manual
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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 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, 700-1060hPa
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 (Third Edition) + CORR. 1:2006
+ CORR. 2:2007 + A1:2012
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/AMD1:2013 Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability
IEC 62366-1 2020 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
Table 2 – EMC Standard of Compliance and Normative References
IEC 60601-1-2, Edition 4.0,
February 1, 2014 Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – collateral standard: electromagnetic
compatibility – requirements and tests
IEC 61000-4-2:2008, ed 2.0 Electromagnetic Compatibility (EMC) Part 4-2: Testing and Measurement
Techniques - Electrostatic Discharge Immunity Test
IEC 61000-4-3 ed 3.0 with A1:2007+A2:2010 Electromagnetic Compatibility (EMC) Part 4-3: Testing and Measurement
Techniques - Radiated, Radiofrequency, Electromagnetic Field Immunity
Test
IEC 61000-4-4:2012, ed 3.0 Electromagnetic Compatibility (EMC) Part 4-4: Testing and Measurement
Techniques - Electrical Fast Transient/Burst Immunity Test