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Product Compliance
Operator’s Manual
11-7
11.7
Product Compliance
11.8
Manufacturer’s Declaration and Guidance
11.8.1
Electromagnetic Compatibility (EMC)
WARNING:
This monitoring system is intended for use by healthcare professionals only. This
monitoring system may cause radio interference or may disrupt the operation of
nearby equipment, regardless of whether it is CISPR compliant or not. It may be
necessary to take mitigation measures, such as re-orienting or relocating the
monitoring system or shielding the location.
WARNING:
The use of accessories, pulse oximetry sensors, and cables other than those specified
may result in inaccurate readings of the monitoring system and increased EMI
emissions or decreased electromagnetic immunity of the monitoring system.
Standards Compliance
EN ISO 80601-2-61: Edition 1.0
EN IEC 60601-1: Edition 3.1
EN IEC 60601-1-2: Edition 3.0 and 4.0
EN IEC 60601-1-6: Edition 3.1
EN IEC 60601-1-8: Edition 2.1
EN IEC 60601-1-11: Edition 2.0
CAN/CSA C22.2 No. 60601-1:14 3rd Edition
ANSI/AAMI ES 60601-1:2005/(R)2012
Equipment Classifications
Type of Protection against electric shock
Class II (internally powered)
Degree of Protection against electric shock
Type BF - Applied part
Mode of Operation
Continuous
Electromagnetic Compatibility
IEC 60601-1-2:2007 (Ed. 3.0) and IEC 60601-1-2:2014 (Ed. 4.0)
Liquid Ingress
IP22: Protected against finger insertion and water dropped vertically
Degree of Safety
Not suitable for use in the presence of flammable anesthetics
Summary of Contents for Nellcor Series
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