K5902142 /07
Nio 5.8MP Gray
44
•
The display is not in the same environment as the patient.
•
The display is intended to be used in a dedicated diagnostic reading room.
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
Not applicable
Intended users
Barco diagnostic and mammography displays are intended to be used for primary diagnosis by trained
medical practitioners. The device is initially set up by trained integrators or medical IT 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 (
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
turning the device 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 device and receiver.
•
Connect the device 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.
Changes or modifications not expressly approved by the party responsible for compliance could void the
user's authority to operate the equipment.
FCC responsible
: Barco Inc., 3059 Premiere Parkway Suite 400, 30097 Duluth GA, United States, Tel: +1
678 475 8000
Canadian notice
CAN ICES-001(B) / NMB-001(B)
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Страница 58: ...www barco com K5902142 07 2022 12 13 Barco NV President Kennedypark 35 8500 Kortrijk Belgium...