Biological Hazard And Returns; Regulatory Compliance Information - Barco MDSC-8427 User Manual

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Important information
10
RoHS
Directive 2011/65/EC on the restriction of certain hazardous substances in electrical and electronic
equipment.
According to what declared by our components suppliers, this product is RoHS compliant.

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 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.

5.4 Regulatory compliance information

Indications for use
This device is intended to be used in operation rooms, to display images from endoscopic cameras, room and
boom cameras, ultrasound, cardiology, PACS, anesthesiology and patient information. It is not intended for
diagnosis.
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
42
R5910599 /00
MDSC-8427

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