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Chapter 10: Compliance Declaration
AAMI ES 60601-1, 2005/(R)
2012 and A2: 2010/(R)2012
IEC 60601-1-2:2007
ISO 10993-1:2009
FCC Part 15b
ICES-003
ISTA-6
Electromagnetic Compatibility (EMC)
This equipment has been tested and found to comply with the limits for a Class B device. The equipment
was tested to IEC 60601-1-2:2007/AC 2010. It was also tested for U.S. FCC emissions to CFR Title 47,
Part 15, Subpart B, and Canada CSA to ICES-003 Issue 4, February 2004 in accordance with CISPSR
22:02.
Warnings
•
Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided.
•
Portable and mobile RF communications equipment can affect medical electrical equipment.
•
Use of accessories, transducers and cables other than those specified may result in increased
emissions or decreased immunity of the equipment. Medical equipment should not be used
adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the medical
equipment should be observed to verify normal operation in the configuration in which it will be
used.
•
This equipment uses and can generate radio frequency energy and, if not used in accordance with
the instructions, may cause harmful interference. If interference is suspected, move equipment
away from sensitive devices or contact the manufacturer. Modifications or use of accessories not
expressly approved by the manufacturer are prohibited and may void the user's authority to
operate the equipment
© 2023 by NeoLight LLC.
All rights reserved.
Medical Electrical Equipment- Part 1: General Requirements for basic
safety and essential performance
Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral Standard:
Electromagnetic Compatibility – Requirements and Tests
Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process
Equipment authorization of unintentional radiators
Issue 4 for a Class B Device – Digital apparatus
Testing Packaging Product Weighing up to 150 lbs.
Page 26 of 30
500055 Rev E
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