PRS 500 E
Instructions for use
5069-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 12 von 47
• For the diagnosis of inflammatory and expansive processes of the mucosa, cranial bones and
paranasal extension.
• For the diagnosis of the abdomen (e.g. acute abdomen, plain abdominal radiography,
urethrogram, cystogram).
1.8 Indication and Contraindication
1.8.1 Indications
According to §83 of the German radiation protection law (StrlSchG), an X-ray examination is only
justified if the patients benefit from X-ray diagnostics outweighs the radiation risk. The examination
method, means the conventional X-ray with the PRS 500 System, must be suitable to answer the
diagnostic question and no other more suitable alternative method is available.
Accordingly, it is also described by the International Atomic Energy Agency (IAEA) in the document
Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards (Requirement
37: Justification of medical exposures). It also refers to the need to consider national or international
guidelines for the justification of a medical exposure.
NOTE
Even if, according to the justifying indication, the benefit predominates the radiation
risk, it must not be disregarded that there are residual risks due to ionising radiation
and that undesirable side effects may occur. Ionising radiation (X-radiation) can
damage the genome and, in the long term, lead to cancer and mutations and thus
damage the human body.
1.8.2 Contraindications
There are no absolute contraindications for conventional X-rays. But it is not allowed to make any
exposures on humans when they are not medically indicated (see justification of medical exposures,).
For pregnant women and children it is important to consider if the exposure is really necessary. It
should be avoided if possible.
1.9 Intended User Group
The X-ray systems of the PRS 500 series are intended exclusively for use by professional users who are
trained in the operation of diagnostic X-ray systems in accordance with the respective national
regulations and who are familiar with the proper handling, use and operation and also have been
instructed in the permitted conjunction with other medical products, objects and accessories.
Appropriate users can be, for example: X-ray technicians, X-ray assistants, medical technical X-ray
assistants, surgeons, casualty surgeons, orthopaedists and other trained medical personnel.
1.10 Declaration of Conformity
This product is in conformity with the requirements of the European Community
Medical Device Directive 93/42/EEC from 06/14/1993 including all current
revision standards.
The declaration of conformity is available directly from PROTEC:
PROTEC GmbH & Co. KG
In den Dorfwiesen 14 | 71720 Oberstenfeld
Telephone: +49 (0) 7062 – 92 55 0
Fax: +49 (0) 7062 – 92 55 60
E-Mail: protec@protec-med.com
Internet:
www.protec-med.com
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