Intended Purpose - Philips MRC 600 Gebrauchsanweisung

Intended Purpose

2 Intended Purpose
Intended Use
The X-ray tube housing assembly is an X-ray generating tube encased in a radiation-shielded
housing. The X-ray tube housing assembly is intended to emit X-ray photons to enable the
creation of diagnostic images of human patients. The X-ray tube housing assembly is only used
as integrated part of an imaging system and has no medical purpose by its own. The intended
treatment, duration and treatment parameters are not defined on X-ray tube housing assembly
level. This is defined by the manufacturer of the imaging system in accordance with the
intended use, the intended purpose and the medical purpose as described in the technical
documentation of the imaging system.
Intended User Population
The X-ray tube housing assembly is remotely controlled by the imaging 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 imaging system in accordance with the
intended use, the intended purpose and the medical purpose as described in the technical
documentation of the imaging system. The X-ray tube housing assembly must be installed,
repaired and maintained only by technically qualified field service engineers who have received
the appropriate instructions and training and who are authorized in particular for the
installation and commissioning of radiography equipment in medical applications.
Intended Context
The X-ray tube housing 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 housing assembly is intended to be used in permanently installed
stationary imaging systems. The use frequency is not limited within the expected service
lifetime. This X-ray tube housing assembly is intended to be used with multiple patients without
any special treatment of the X-ray tube housing assembly between examinations. Additional
treatment for use with multiple patients may be required and verified by the manufacturer of
the imaging system for specific applications.
Operating Principles
Contraindications are not defined on X-ray tube housing assembly level, because this is defined
by the manufacturer of the imaging system in accordance with the intended use, the intended
purpose and the medical purpose as described in the technical documentation of the imaging
system. Specific warnings are provided within the accompanying documents of the X-ray tube
housing assembly. The expected service lifetime is referenced in the risk management file and
stated in the accompanying documents of the X-ray tube housing 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
system in which it is integrated.
X-Ray Tube AssembliesX-Ray Tube Assemblies 7