Natus Quantum Amplifier
User & Service Manual
10
2. Safety & Standards Conformity
2.1. Standards of Compliance and Normative References
Multichannel Sleep/EEG Headbox System, Model Quantum Amplifier, detachable cord connected,
portable 100-230Vac, 50/60Hz, 80VA.
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: 10-30°C, 30-75% rH, 700-1060hPa
The
Quantum 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 + 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
