natus neuro Embla Dx Series, User And Service Manual

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Natus® Brain Monitor &
Embla Dx Series™
User and Service Manual
8
Safety & Standards Conformity
Standards of Compliance and Normative References
Multichannel Sleep/EEG Headbox System, Models: Brain Monitor, Embla NDx, Embla SDx Amplifiers,
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 Brain Monitor & Embla Dx Series Amplifiers and accessories have been designed to comply with
the following national and international standards.
Safety Standard of Compliance and Normative References

IEC 60601-1:2012 - General Safety Third Edition

CAN / CSA-C22.2 No. 60601-1: 08(R2013) +C2:2011

IEC 60601-1-6:2010
– Usability Third Edition

IEC 62366:2007, Edition 1.0

IEC 60601-2-26:2012
– Electroencephalographs Third Edition

IEC60601-2-61:2011 - Pulse Oximeters

EN ISO 80601-2-61:2011, Edition 1
EMC Standard of Compliance and Normative References

IEC 60601-1-2:2014
– EMC Fourth Edition

IEC 61000-3-2:2014, Fourth Edition

IEC 61000-3-2 Harmonic emissions
– Class A

IEC 61000-3-3:2013, Third Edition Voltage Fluctuations/ Flicker emissions

CISPR11, Edition 5.0 A1:2010 RF emissions
– Group 1, Class A

IEC 61000-4-2:2008, Second Edition

IEC 61000-4-2 Electrostatic Discharge (ESD) ±8 kV contact (to the patient lead and expose
metal), ±15 kV air

IEC 61000-4-3 Third Edition with A1:2007+A2:2010

IEC 61000-4-3, 3 Vrms, 80 MHz to 2.7 GHz

IEC 61000-4-4:2012, Third Edition, fast transient/burst ±2 kV power supply ±1 kV

IEC 61000-4-5:2014, Third Edition

IEC 61000-4-5 ±1 kV Surge differential mode ±2 kV common mode

IEC 61000-4-6 Second Edition with A1:2004 + A2:2006

IEC 61000-4-6, 150 kHz to 80 MHz

IEC 61000-4-8:2009, Second Edition

IEC 61000-4-8, Power frequency (50/60 Hz) magnetic field, 30 A/m