PROGNOST F
Instructions for use
5041-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
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1.5
Indication and Contraindication
1.5.1
Indication
The X-ray system component PROGNOST F, considered as a single component, has no indication and
no contraindication. Since this X-ray system component is intended for connection with other X-ray
system components, the indication and contraindication of an entire X-ray system are considered.
A complete list of indications is unrealisable for conventional radiography, because the spectrum of
conventional X-rays is very diverse and can vary in the course of medical-technical progress.
Some examples of indications for an X-ray examination may be:
•
For the diagnosis of a bone fracture or bony injuries of the skeletal system or pathological
changes of hard tissues.
•
To control the bone setting.
•
For the diagnosis of luxations and ligament ruptures of the locomotor system.
•
For the diagnosis of degenerative, inflammatory, traumatic and tumorous diseases and
changes of the locomotor system.
•
For diagnostic of malformations and malalignments of the skeletal system.
•
For the diagnosis of thoracic and pulmonary symptoms (thorax exposures)
•
For the diagnosis of sclerotherapy.
•
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).
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.
1.5.2
Contraindication
•
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
•
For pregnant women and children it is important to consider if the exposure is really necessary.
It should be avoided if possible.
1.6
Intended user group
The PROGNOST F is exclusively designated for use by professional users who are trained to operate
diagnostic X-ray equipment, in accordance with the corresponding national regulations, and who were
instructed in the proper (certified) use, application and operation as well as in the permissible
connection with other medical devices, objects and accessories.
Suitable user groups could include the following: Radiologist, radiology assistants, radiology
technicians, doctors and other medically trained personnel.