Intended Purpose
X-Ray Tube Assemblies 7
Dunlee 300004427481C / D000411792E/740 * 03/2020
Intended Purpose
Intended use
The X-ray tube assembly is an X-ray generating tube encased in a radiation-shielded housing.
The X-ray tube assembly is intended to emit X-ray photons to enable the creation of diagnostic
images of human patients. The X-ray tube assembly is only used as integrated part of an X-ray
system and has no medical purpose by its own. The intended treatment, duration and treat-
ment parameters are not defined on X-ray tube assembly level. This is defined by the manufac-
turer of the X-ray system in accordance with the intended use, the intended purpose and the
medical purpose as described in the technical documentation of the X-ray system.
Intended user population
The X-ray tube assembly is remotely controlled by the X-ray system, which itself is operated by
qualified clinical users only. Further details regarding the intended user and patient population
are defined by the manufacturer of the X-ray system in accordance with the intended use, the
intended purpose and the medical purpose as described in the technical documentation of the
X-ray system. The X-ray tube assembly must be installed, repaired and maintained only by tech-
nically qualified field service engineers who have received the appropriate instructions and
training and who are authorized in particular for the installation and commissioning of radiogra-
phy equipment in medical applications.
Intended context
The X-ray tube assembly is intended to be used in a non-condensing, climate controlled, indoor,
clinical environment and is not intended to be used for homecare or by lay persons. The X-ray
tube assembly is intended to be used in permanently installed stationary X-ray systems. The use
frequency is not limited within the expected service lifetime. This X-ray tube assembly is intend-
ed to be re-used. The re-use of this X-ray tube assembly does not require any special treatment.
Additional treatment for re-use may be required and verified by the manufacturer of the X-ray
system for specific applications.
Operating principles
Contraindications are not defined on X-ray tube assembly level, because this is defined by the
manufacturer of the X-ray system in accordance with the intended use, the intended purpose
and the medical purpose as described in the technical documentation of the X-ray system. Spe-
cific warnings are provided within the accompanying documents of the X-ray tube assembly.
The expected service lifetime is referenced in the risk management file and stated in the ac-
companying documents of the X-ray tube assembly.
Essential performance
The X-ray tube assembly does neither have essential performance per se. Nor is any function of
the X-ray tube assembly intended to contribute to the essential performance of the X-ray sys-
tem in which it is integrated.
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