7. Important information
CAUTION: 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)
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 re-
ceived, 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 modi
fi
cations not expressly approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
Canadian notice
CAN ICES-3 (B)/NMB-3(B)
7.4
EMC notice
General information
No speci
fi
c requirement on the use of external cables or other accessories except power supply.
With the installation of the device, use only the delivered power supply or a spare part provided by the
legal manufacturer. Using another can result in a decrease of the immunity level of the device.
Electromagnetic emissions
The Mammo Tomosynthesis is intended for use in the electromagnetic environment speci
fi
ed below. The
customer or the user of the Mammo Tomosynthesis should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –
Guidance
RF emissions
CISPR 11
Group 1
The Mammo Tomosynthesis uses
RF energy only for its internal
function. Therefore, its RF
emissions are very low and are
not likely to cause any interference
in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class D
Voltage
fl
uctuations/
fl
icker
emissions
IEC 61000-3-3
Complies
The Mammo Tomosynthesis
is suitable for use in all
establishments, including
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes.
K5902035
MAMMO
TOMOSYNTHESIS
07/12/2017
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