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.

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 addresses

• Barco NV, President Kennedypark 35, 8500 Kortrijk, Belgium
• BARCO S.R.L., Via Saul Banfi 1, 21047 Saronno, VA, Italy

• 巴可（苏州）医疗科技有限公司, 苏州工业园区苏桐路111号

  Barco (Suzhou) Healthcare Technology Co., Ltd., No.111, Sutong Road, Suzhou Industrial Park, 215021 Suzhou 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.
• Consult the dealer or an experienced radio/TV technician for help.

Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

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

Canadian notice

CAN ICES-001(B) / NMB-001(B)

Brazilian local representative

Barco Ltda, Av. Ibirapuera, 2332 - Andar 8 - Bloco 2 - Conj 82, Bairro:Ibirapuera, Distrito:Moema, 4028-002, São Paulo, Brasil