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
- Equipment primarily for use in a health care facility that is intended for use where contact with a patient is unlikely (no applied part).
- The equipment shall not be used with life support equipment.
- The user should not touch the equipment, nor its signal input ports (SIP)/signal output ports (SOP) and the patient at the same time.
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