natus XLTEK EEG32U, Руководство пользователя и обслуживания

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XLTEK EEG32U Amplifier User and Service Manual
8
EEG32U Safety and Standards Conformity
Standards of Compliance and Normative References
32 Channel Electroencephalograph (EEG) Headbox; 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 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 EEG32U 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
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