Performance Characteristics; Intended Use; Clinical Benefit; Patient Target Group(S) - Protec COMPACT 2 Instructions For Use Manual

V6.0_2021-05-25
Contact information of persons qualified by designation of the manufacturer to perform the installation
is available upon request from:
1.3

Performance Characteristics

•
Extremely high capacity
•
Intermediate film rinse avoids carryover of chemicals
•
Precise film surface detection for calculation of replenishment rate
•
Excellent image quality and consistency
1.4

Intended Use

The automated X-ray film processor is intended for automatic development of X-ray films
in human medicine.
1.5

Clinical Benefit

The clinical benefit of using X-ray film processors is the development of X-ray films into two-
dimensional X-ray images for creation or specification of findings as a basis for treatment decisions.
In analog X-ray diagnostics, X-ray film processing plays a very important role and makes an essential
contribution to the application of this procedure. After the human body and the X-ray films have been
irradiated, the X-ray film is generated with the aid of chemicals. Only after X-ray film generation, the X-
ray films can be used for examination or diagnosis. Therefore, for the X-ray film processors, the general
clinical benefit is valid for analog conventional X-ray examinations within the intended use.
1.6

Patient Target Group(s)

As X-ray film processors are not intended for use on patients, no intended patient group can be
identified for them.
The intended patient group for a diagnostic X-ray imaging in human medicine 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

Conventional X-ray images can be used to diagnose medical conditions.
A complete list of medical conditions to be diagnosed is not feasible, as the range of conventional
radiographs is very diverse and may also very in the course of medical-technical progress.
Examples for medical conditions to be diagnosed are:
•
Bone fracture or bony injuries of the skeletal system or pathological changes of the bony tissue.
•
Control of the correct set-up of the fracture.
•
Luxation and bony ligament tears of the musculoskeletal system.
•
Degenerative, inflammatory, traumatic and tumorous diseases and changes of the
musculoskeletal system.
•
Deformities and defective positions of the skeletal system.
•
Thoracic and pulmonary symptomatology (thorax exposures).
•
Sclerosis.
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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