5. Important information
Therefore use of this device in such environments is at the exclusive risk of Customer. In case this device
is used where potential biological contamination cannot be excluded.
Customer shall implement the decontamination process as de
fi
ned in the latest edition of the ANSI/AAMI
ST35 standard on each single failed Product that is returned for servicing, repair, reworking or failure
investigation to Seller (or to the Authorized Service Provider). At least one adhesive yellow label shall be
attached on the top site of the package of returned Product and accompanied by a declaration statement
proving the Product has been successfully decontaminated.
Returned Products that are not provided with such external decontamination label, and/or whenever such
declaration is missing, can be rejected by Seller (or by the Authorized Service Provider) and shipped back
at Customer expenses.
5.4
Regulatory information
Indications for use
The Nio Color 2MP 23" is intended to be used as a tool in displaying and viewing digital images (excluding
digital mammography) for review and analysis by trained medical practitioners. Caution (USA): Federal
law restricts this device to sale by or on the order of a physician. (Details & exemptions are in the Code
of Federal Regulations Title 21, 801 Part D).
FCC class B
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and (2) this device must accept any interference re-
ceived, including interference that may cause undesired operation.
This device has been tested and found to comply with the limits for a Class B digital device, pursuant to
Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This device generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this device does cause harmful interference to radio or television reception, which can be
determined by turning the device off and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
•
Reorient or relocate the receiving antenna.
•
Increase the separation between the device and receiver.
•
Connect the device into an outlet on a circuit different from that to which the receiver is connected.
•
Consult the dealer or an experienced radio/TV technician for help.
Changes or modi
fi
cations not expressly approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
Canadian notice
CAN ICES-1/NMB-1
5.5
EMC notice
General information
No speci
fi
c requirement on the use of external cables or other accessories except power supply.
With the installation of the device, use only the delivered power supply or a spare part provided by the
legal manufacturer. Using another can result in a decrease of the immunity level of the device.
K5902134 NIO COLOR 2MP 23" 05/07/2017
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