Indications And Contraindications; Indication; Contraindication; Intended User Group - Protec COMPACT 2 Instructions For Use Manual

V6.0_2021-05-25
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Inflammatory and expansive processes of the mucous membrane, craniofacial bones and the
expansion of the paranasal sinuses.
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Disease of the abdominal cavity (e.g., acute abdomen, abdominal overview radiograph,
urethrogram, cystogram).
1.8

Indications and Contraindications

1.8.1

Indication

As X-ray film processors have no intended main effect in or at the human boy, no indications can be
shown for them.
The indication for diagnostic X-ray imaging in human medicine is always given when the patient
derives a benefit from X-ray diagnostics that outweighs the radiation risk (justifying indication).
1.8.2

Contraindication

As X-ray film processors have no intended main effect in or at the human boy, no contraindications can
be shown for them.
There are no absolute contraindications for diagnostic X-ray imaging in human medicine.
However, only medically indicated radiographs may be performed on individuals.
For pregnant women and children, strong consideration must be given to whether a radiograph is
necessary. If possible, it should be avoided.
1.9

Intended User Group

X-ray film processors are intended exclusively for use by professional users who are trained in the
proper handling, use and operation as well as 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 complies with the requirements of Regulation (EU) 2017/745 of the European
Parliament and of the Council of 5 April 2017 concerning medical devices, including all
applicable corrigenda.
The declaration of conformity is available on request from:
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
COMPACT 2 Instructions for use
PROTEC GmbH & Co. KG
Germany
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
5190-0-0002
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