6. Important information
Customer shall implement the decontamination process as de
fi
ned 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.
6.4
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 in-
tended for diagnosis.
FCC Class B (valid for MDSC-2224 LED version)
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 equipment 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 equipment 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 equipment does cause harmful interference to radio or television reception, which can
be determined by turning the equipment 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 equipment and receiver.
•
Connect the equipment 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.
FCC Class A (valid for MDSC-2224 MNA version)
This equipment has been tested and found to comply with the limits of a class A digital device, pursuant
to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful
interference when the equipment is operated in a commercial environment. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruc-
tion manual, may cause harmful interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user will be required to correct
the interference at his own expense.
Canadian notice
This ISM device complies with Canadian ICES-001.
Cet appareil ISM est conforme à la norme NMB-001 du Canada.
52
(451920611391)K5903031 MDSC-2224 21/01/2014
