Regulatory Compliance Information - Barco Nio 2MP LED User Manual

6.4 Regulatory compliance information

Indications for use
The display is intended to be used for displaying and viewing digital images (excluding digital mammography)
for review and analysis by trained medical practitioners.
Intended usage environment
• The display is not in contact with patients.
• The display is not in the same environment as the patient.
• The display is intended to be used in a dedicated diagnostic reading room.
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).
Contra-indications
The device is not intended for digital mammography.
Intended users
Barco diagnostic displays are intended to be used for primary diagnosis by trained medical practitioners. The
device is initially set up by trained integrators or medical IT staff.
Expected clinical benefits
The device aids in diagnosing patients.
Notice to the user and/or patient
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established.
Factory address
Coretronic Projection (Kunshan) Corp, No.20, 3rd Ave, Kunshan Free Trade Zone, Kunshan, Jiangsu, 215300
China
Manufacturing country
The manufacturing country of the product is indicated on the product label ("Made in ...").
Importers contact information
To find your local importer, contact one of Barco's regional offices via the contact information provided on our
website (www.barco.com).
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 received,
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.
Important information
K5903058 /11 Nio 2MP LED Display 39