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| Warnings and Cautions
CAUTION!
In case of serious incident
Please report any serious incident that has occurred in relation to the device to the manu-
facturer and the competent authority of the State in which the user and/or patient is estab-
lished.
CAUTION!
This product is a Class I medical device according to the MDR in Europe. No modifications
are allowed.
CAUTION!
This product is a Class II medical device in the United States and Canada. No modifications
are allowed.
CAUTION!
Do not use this product in the presence of flammable anesthetics mixture with air, oxygen
or nitrous oxide.
NOTE!
This equipment/system is intended for use by healthcare professionals only.
NOTE!
There are no user serviceable parts inside. Refer servicing to qualified service personnel.
NOTE!
This product is designed to meet medical safety requirements for a patient vicinity device.
Do not use in MR Environments
Hereby, NDS Surgical Imaging, LLC, declares that this ZeroWire 4K System is in compliance with the essential
requirements and other relevant provisions of Directive 2014/53/EU. The full text of the EU Declaration of Con-
formity is available upon request.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Radio Approval:
This device meets the requirements of EN302 567 and conforms to Radio and Equipment Directive (RED)
2014/53/EU.
FCC Identification:
UK2-SII-SK63102, UK2-SII-SK63101 or 2ASUJ-SII-SK63102, 2ASUJ-SII-SK63101
Industry Canada:
6705A-SIISK63102, 6705A-SIISK63101 or 25001-SIISK63102, 25001-SIISK63101
This product complies to the above standards only when used with an NDS supplied medical grade power
supply.