Biological Hazard And Returns; Regulatory Information - Barco MDRC-1219 (TS) 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 Chi-
nese 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 environ-
ment-friendly use period of electronic information products" of Chinese Mainland.
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5.3

Biological hazard and returns

Overview
The structure and the specifications of this device as well as the materials used for manufacturing makes
it easy to wipe and clean and therefore suitable to be used for various applications in hospitals and other
medical environments, where procedures for frequent cleaning are specified.
However, normal use shall exclude biological contaminated environments, to prevent spreading of infec-
tions.
Therefore use of this device in such environments is at the exclusive risk of Customer. In case this device
is used where potential biological contamination cannot be excluded.
Customer shall implement the decontamination process as defined in the latest edition of the ANSI/AAMI
ST35 standard on each single failed Product that is returned for servicing, repair, reworking or failure
investigation to Seller (or to the Authorized Service Provider). At least one adhesive yellow label shall be
attached on the top site of the package of returned Product and accompanied by a declaration statement
proving the Product has been successfully decontaminated.
Returned Products that are not provided with such external decontamination label, and/or whenever such
declaration is missing, can be rejected by Seller (or by the Authorized Service Provider) and shipped back
at Customer expenses.
5.4

Regulatory information

Indications for use
The MDRC-1219 (TS) is intended to be used as a tool in displaying and viewing digital images (excluding
digital mammography) for review and analysis by trained medical practitioners. 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).
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 re-
ceived, 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
K5902128 (451920612451) MDRC-1219 (TS) 03/11/2016
5. Important information
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