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CAUTION
Unauthorized modification could lead to loss of device function or performance.
•
Do not modify the device.
Unintended motion of the cart while in use or if left unattended may cause the cart or accessories
to fall, leading to injury of user/patient.
Ensure that all wheel castors are locked before using the system for patient testing or when left
•
unattended.
The amplifier arm is spring-loaded and may snap open when the tie wrap or accessory is
removed, leading to possible injury.
•
Restrain the amplifier arm before removing the tie wrap or accessory.
Swinging the amplifier arm into the monitor screen may cause screen to break, leading to injury
of user/patient.
Do not swing the amplifier arm into the monitor screen.
•
When used by untrained user, the device could lead to patient injury.
This device is intended to be used by qualified healthcare professionals.
•
Transporting the cart with the monitor or amplifier arm extended could lead to instability and/or
damage to the arms.
Ensure that the arms are in a retracted position (over the cart surface) before transporting the
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cart.
Compliance Standards:
ISO 10993-1: 2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
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management process
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems for
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Vibration
IEC 60601-1:2005+A1:2012 - General Safety Ed. 3.1
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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
natus.com
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