Barco Nio MDNC-3521 SNES, User Manual

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R5915130 /05 Nio 2MP / 3MP LED Display 50
7.4 Regulatory compliance information
Indications for use
The display is intended to be used for displaying and viewing digital images (excluding digital mammography)
for review and analysis by trained medical practitioners.
Intended usage environment
• The display is not in contact nor in the same environment (within 1.5m) as a person actively undergoing a
medical, surgical or dental procedure.
• The device is intended to be used in a healthcare facility or a medical professional’s workplace.
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).
Contra-indications
• The device is not intended for digital mammography.
• The device is not intended to be used in conjunction with high powered medical equipment (HF surgical
equipment, short-wave therapy equipment, equipment inside the RF shielded room for magnetic
resonance imaging).
Intended users
Barco diagnostic displays are intended to be used for primary diagnosis by trained medical practitioners. The
device is initially set up by professional integrators or medical staff.
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.
Factory addresses
• Barco NV , President Kennedypark 35, 8500 Kortrijk, Belgium
• Fimi S.r.l. , Via Saul Banfi 1, 21047 Saronno, VA, Italy
•
巴可（苏州）医疗科技有限公司
,
苏州工业园区苏桐路
111
号
Barco (Suzhou) Healthcare Technology Co., Ltd. , No.111, Sutong Road, Suzhou Industrial Park,
215021 Suzhou China
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
Important information