PIXIUM STATIC X-Ray Flat Panel Detectors - End User Manual
Document reference : 63137046 -
January 2024
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• an X-ray flat panel detector which allows acquiring raw X-ray images;
• an image pre-processing software called PixRad that converts the detector raw images in clean images ready to
be used by the OEM system for further processing.
Thales RAD products are active medical devices. They are designed to convert low intensity X-ray images into a digital
images for medical diagnosis or therapeutic interventional radiology. They can also be used in more universal medical
applications, as a part of imaging chain of an overall radiology system.
The Thales X-Ray flat panel is meant to be integrated into a full x-ray imaging equipment by an OEM
5.3. IT networks characteristics
5.3.1. PC HOST characteristics
The PixRad software is compatible with the following operating systems:
• Windows 7 and Windows 10 / 32 bits
• Windows 7 and Windows 10 / 64 bits
5.4. IT Security
All IT security measures, including protection against unauthorized access, necessary to run the software as intended
shall be taken. Please refer to Good practices for the security of healthcare services recommended by ENISA.
5.5. Product Legal Manufacturer and Manufacturing Site
5.6. Intended User
For a given host, its Ethernet interface must have only one defined IP address..
Pixium detectors are intended to be integrated by technical employees of Original Equipment
Manufacturer having an expertise in the integration of flat panel detector. The OEM integrator can
be located worldwide and has a working level in English.
Thales does not distribute the detectors to the end-users but only to OEMs (or retrofitters) who are
responsible of the product integration into the complete system.The clinical end-users are
intended to be qualified/trained doctors or technicians.
According to the impact that system components and integration may have on the product,
performances are under integrator responsibility, especially to prevent image to freeze in case of
inadequate PC workload and which could lead to a wrong patient diagnostic or treatment.