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Compliance Standards:
•
ISO 10993-1: 2018 Biological evaluation of medical devices
— Part 1: Evaluation and testing within a
risk management process
•
ETSI EN300 019-2-1 Environmental Engineering (EE); Environmental conditions and environmental
tests for telecommunications equipment; Part 2-1: Specification of environmental tests; Storage
•
ETSI EN300 019-2-2 Environmental Engineering (EE); Environmental conditions and environmental
tests for telecommunications equipment; Part 2-2: Specification of environmental tests;
Transportation
•
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems for
Vibration
•
IEC 60601-1:2005+A1:2012 Medical Electrical Equipment
– Part 1: General Requirements for Basic
Safety and Essential Performance
•
IEC 60601-1-2: 2014
– EMC Fourth Edition: Medical Electrical Equipment – Part 1-2: General
Requirements for Safety
– Collateral Standard: Electromagnetic Compatibility – Requirements and
Tests, 4th Edition
Disposal Instructions:
Natus is committed to meeting the requirements of the European Union WEEE (Waste Electrical and
Electronic Equipment) Regulations 2014. These regulations state that electrical and electronic waste
must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or
recycled safely. In line with that commitment Natus may pass along the obligation for take back and
recycling to the end user, unless other arrangements have been made. Please contact us for details on
the collection and recovery systems available to you in your region at
Electrical and electronic equipment (EEE) contains materials, components and substances that may be
hazardous and present a risk to human health and the environment when WEEE is not handled correctly.
Therefore, end users also have a role to play in ensuring that WEEE is reused and recycled safely. Users
of electrical and electronic equipment must not discard WEEE together with other wastes. Users must use
the municipal collection schemes or the producer/importers take-back obligation or licensed waste
carriers to reduce adverse environmental impacts in connection with disposal of waste electrical and
electronic equipment and to increase opportunities for reuse, recycling and recovery of waste electrical
and electronic equipment.
Equipment marked with the below crossed-out wheeled bin is electrical and electronic equipment. The
crossed-out wheeled bin symbol indicates that waste electrical and electronic equipment should not be
discarded together with unseparated waste but must be collected separately.
Disclaimer:
Any serious incident that has occurred in relation to the device should be reported to Natus Medical
Incorporated DBA Excel-Tech Ltd. (Xltek) and the competent authority of the Member State in which the
user and/or patient is established.
Refer to the Natus website for an electronic copy of this document.
