Barco MUIP-2112, User Manual

Page: 23 / 36

23 K5902132 (451920612534) /03 MUIP-2112
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 ” .
SDoC
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.
4.3 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 infections.
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.
4.4 Regulatory information
Intended Purpose
MUIP-2112 is a general hardware platform for use in the hospital environment. It can be used for third party
software applications that provide a user interface for medical systems. The equipment can be used in
CathLab Examination Rooms & Control Rooms, Surgical Rooms and Hybrid Operating Rooms, both inside
and outside the patient area. The equipment is not intended to be used for displaying medical images, nor for
diagnostic purposes.
Factory address
Fimi S.r.l. , Via Saul Banfi 1, 21047 Saronno, VA, Italy
Manufacturing country
The manufacturing country of the product is indicated on the product label ( “ Made in …” ).
Important information