Indications for use

The display is intended to be used in displaying and viewing digital images, including standard and multiframe digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

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

Not applicable

Intended users

Barco diagnostic and mammography 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
• Fimi 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

Taiwan notice

義務信

• 一、商品在國內產製時，為商品之產製者或輸出者。

  但商品委託他人產製，並以在國內有住所或營業所之委託者名義，於國內銷售或輸出時，為委託者。

• 二、商品在國外產製時，為商品之輸入者。

  但商品委託他人輸入，並以在國內有住所或營業所之委託者名義，於國內銷售時，為委託者。

• 三、商品之產製者、輸出入者、委託產製或委託輸出入者不明或無法追查時，為銷售者。

  前項所稱產製者，包括具有下列情形之一者：

  組裝者：商品由個別零組件以組裝銷售。

  修改者：符合檢驗規定之商品於進入市場前，為銷售目的而修改。