Hologic Faxitron CT, User Manual

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FAXITRON CT USER MANUAL | HOLOGIC | REVISION 002
SECTION
Compliance
and Safety
6
6-2
Requirements | Faxitron CT Compliance
Emission Limits
Radiation emitted from the Faxitron CT unit does not exceed an exposure of 0.1 milli-
Roentgen (mR) per hour at any point 5 centimetres (cm) outside the external surface.
For countries requiring emission values measured at 10 cm from the external surfaces, the
radiation does not exceed 1.0
u S/hr per hour at 10 cm.
Safety Interlocks
Faxitron CT system has two independent safety interlocks on the specimen door.
Start Button
Following interruption of X-Ray generation by the safety interlocks, the Start button on the
front panel will resume X-Ray generation when ready.
Password Control
The control system is protected with a Password that must be entered to generate X-Rays.
Stop Button
Along with the software and touch panel Stop button there is a physical Stop button on the
Faxitron CT front panel to terminate the generation of X-Rays. This is in addition to the safety
interlocks on the system doors.
X-Ray Generation Indicators
The Faxitron CT has an X-Ray On indicator light on the front panel, on the touch panel and
graphical user interface, plus it produces an audible tone when generating X-Rays.
Power Ratings
120VAC 60Hz or 230VAC 50Hz 700W Max.
Tested Standards
Testing carried out by Intertek, a US Nationally Recognized Testing Laboratory and
European Notified Body
UL 61010-1
3rd Edition, 2012-05
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory
Use.
IEC 61326-1: 2012
Electrical equipment for measurement, control and laboratory use - EMC requirements.
IEC 61326-2-6: 2013
Electrical equipment for measurement, control and laboratory use - EMC requirements. Part
2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Complies with DHHS radiation performance standards, 21 CFR, Subchapter J
DICOM Version
Faxitron CT uses the latest DICOM standard:
ACR-NEMA Digital Imaging and Communications in Medicine (DICOM) v3.0, Final Draft,
Aug. 1993.
And complies with:
NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communications In Medicine Set
See DICOM Conformance Statement for more Information
6.1.0
Compliance
Requirements and
Safety Measure
6.2.0
DICOM Standard