Faxitron CT Specimen Radiography System User Guide
Chapter 2: General Information
5081-9544 Revision 004 Page 15
Caution:
This system is intended for use by healthcare professionals only. This system may
cause radio interference or may disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures, such as re-orienting or relocating the
equipment or shielding the location.
Caution:
The emissions characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required), this equipment might not offer
sufficient protection to radio frequency communication services. The user may need
to take mitigation measures, such as relocating or re-orienting the equipment.
Caution:
The Medical Electrical (ME) Equipment or ME System should not be used adjacent to
or stacked with other equipment. If adjacent or stacked use is necessary, make sure
that the ME Equipment or ME System operates correctly in this configuration.
Caution:
Changes or modifications not expressly approved by Hologic could void your
authority to operate the equipment.
2.5.2 Compliance Statements
The manufacturer states this device is made to meet the following requirements:
IEC, EN:
• IEC 61010-1: 2010, 3rd Edition - Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use; Part 1: General Requirements
• IEC 61010-2-091:2012, 1
st
Edition – Safety requirements for electrical equipment for
measurement, control and laboratory use – Part 2-091: Particular requirements for
cabinet X-ray systems
• IEC 61010-2-101:2015, 2
nd
Edition - Safety requirements for electrical equipment for
measurement, control and laboratory use – Part 2-101: Particular requirements for
IVD medical equipment
• EN 61326-1:2013 - Electrical Equipment for Measurement, Control, and Laboratory
Use – EMC Requirements – Part 1: General Requirements
• EN 61326-2-6:2013 - Electrical equipment for measurement, control, and laboratory
use – EMC requirements – Part 2-6: Particular requirements – IVD medical
equipment
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