V5.0_2022-04-26
PROGNOST B Instructions for use
5014-0-1002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
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1.4
Intended use
The X-ray system mechanics PROGNOST B is designated as a component to be
used for the assembly of a diagnostic X-Ray system for various routine applications in planar X-ray
imaging in human medicine.
1.5
Clinical Benefit
Considered in isolation, no clinical benefit can be shown for X-ray system mechanics.
As components of diagnostic X-ray systems in human medicine, they contribute to the clinical benefit
of X-ray systems, which consists of the generation of conventional two-dimensional X-ray images for
creation or specification of findings as a basis for treatment decisions.
1.6
Patient Target Group(s)
The intended patient group includes all people for whom a justifying indication for a medical X-ray has
been given by a physician with the necessary expertise in radiation protection.
There are no general or fundamental restrictions on the patient group regarding age, gender, origin
and patient condition.
1.7
Medical Conditions to be diagnosed
As standalone products, X-ray system mechanics, have no function to diagnose, treat and/or monitor
medical conditions.
1.8
Indications and Contraindications
As standalone products, X-ray system mechanics have no intended main effect in or at the human
body. Therefore, considered in isolation, no indications or contraindications can be shown for them.
1.9
Intended User Group
As a component of a diagnostic X-ray system, PROGNOST B is 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, orthopedists 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 on medical
devices, including all applicable corrigenda.
The declaration of conformity is available upon request from PROTEC:
PROTEC GmbH & Co. KG
In den Dorfwiesen 14 | 71720 Oberstenfeld
Germany
Phone: (+ 49) 7062 92 55 0
Fax: (+ 49) 7062 92 55 60
E-Mail: [email protected]
Internet: www.protec-med.com