6.6 Regulatory compliance information

Indications for use

This device is a color high-resolution liquid crystal display especially designed for medical imaging applications.

The monitor is used in a hospital environment and remain physically attached, upright, as part of a fixed, stationary, indoor system. For the use in control room an optional stand can be provided. It is not intended for diagnosis.

Intended usage environment
Contra-indications

This display is not intended to be used for direct diagnosis and therapeutic interventional radiology.

Intended users

Surgical displays are intended to be used by trained medical practitioners.

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.

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 A

This equipment has been tested and found to comply with the limits of a class A digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

FCC responsible: Barco Inc., 3059 Premiere Parkway Suite 400, 30097 Duluth GA, United States, Tel: +1 678 475 8000

Canadian notice

CAN ICES-003 (B) / NMB-003(B)

UKCA compliance

UK Responsible Person (UKRP): Barco UK Ltd, Building 329, Doncastle Road, Bracknell RG12 8PE, Berkshire, United Kingdom