V1.0_2021-05-17
PROGNOST XP, XPE, XPE-Akku
Instructions for use
5038-0-0002
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1.5
Clinical Benefit
Considered in isolation, no clinical benefit can be shown for X-ray system tables.
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 tables, have no function to diagnose, treat and/or monitor
medical conditions.
1.8
Indications and Contraindications
As standalone products, X-ray system tables have no intended main effect in or on 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, products of the PROGNOST XP-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 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