Regulatory Compliance Information - Barco Nio Fusion12MP User Manual

在中国大陆销售的相应电子信息产品（EIP）都必须遵照中国大陆《电子电气产品有害物质限制使用标识要
求》标准贴上环保使用期限（EFUP）标签。Barco产品所采用的EFUP标签（请参阅实例，徽标内部的编号使
用于指定产品）基于中国大陆的《电子信息产品环保使用期限通则》标准。
All Electronic Information Products (EIP) that are sold within Chinese Mainland must comply with the "Marking
for the restriction of the use of hazardous substances in electrical and electronic product" of Chinese
Mainland, marked with the Environmental Friendly Use Period (EFUP) logo. The number inside the EFUP
logo that Barco uses (please refer to the photo) is based on the "General guidelines of environment-friendly
use period of electronic information products" of Chinese Mainland.
10
中国RoHS自我声明符合性标志 / China RoHS – SDoC mark
本产品符合《电器电子产品有害物质限制使用管理办法》和《电器电子产品有害物质限制使用达标管理目录》
的要求。
This product meets the requirements of the "Management Rule on the Use Restriction of Hazardous
Substances in Electrical and Electronic Products" and the "Management Catalogue for the Use Restriction of
Hazardous Substances in Electrical and Electronic Products".
绿色自我声明符合性标志可参见电子档文件
The green SDoC mark is visible in the digital version of this document.

7.3 Regulatory compliance information

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 address
Barco NV, President Kennedypark 35, 8500 Kortrijk, Belgium
Important information
R5913350 /02 Nio Fusion 12MP 53