Eu Declaration Of Conformity For Medical Applications; Regulatory Compliance Information - Barco AMM215WTD User Manual

Important information
7.3 EU Declaration of Conformity for Medical
Applications
Declaration of Conformity
A Declaration of Conformity has been filed for this product. A sample of this document may be found in the
addendum which accompanies this manual. For a copy of the Declaration of Conformity document, contact
Barco, Inc. and request the AMM215WTD DoC.

7.4 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.
Intended usage environment
• Equipment primarily for use in a health care facility that is intended for use where contact with a patient is
unlikely (no applied part).
• The equipment shall not be used with life support equipment.
• The user should not touch the equipment, nor its signal input ports (SIP)/signal output ports (SOP) and the
patient at the same time.
Contra-indications
This display is not intended to be used for direct diagnosis and therapeutic interventional radiology.
Intended users
Surgical displays are intended to be used by trained medical practitioners.
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.
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 equipment has been tested and found to comply with the limit 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 typical medical 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 other devices in the vicinity. However,
there is no guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to other devices, 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 device.
• Increase the separation distance between the equipment.
• Connect the equipment to an outlet on a circuit different from that to which the other device(s) are
connected.
36 R5912860 /13 AMM215WTD