Pro-tec PRS 500 F User manual

PROTEC GmbH & Co. KG
In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
Telephone: [phone] E-Mail: [email protected]
Version: 6.0
Issued: 2022-01-1
Subject to alterations
PRS 500 F
Basic diagnostic X-ra s stem
Model/ID: 7067-9-8050_Vxxx
Basis_UDI-DI: 426050264X006ZM
Instructions for use
Ident. Nr. 5067-0-8002
PRS 500 F in analogue base configuration

NOTE
All sheets of this document contain proprietary and confidential information of
PROTEC GmbH & Co. KG and is intended for exclusive use by current PROTEC GmbH
& Co. KG customers. Copying, disclosure to others or other use is prohibited without
the express written consent of PROTEC´s law department. Knowledge of violations
of these regulations must be reported immediately to PROTEC GmbH & Co. KG.
© 2022 PROTEC GmbH & Co. KG, Oberstenfeld
These accompanying documents were created and distributed by the documentation department.
Comments and questions about the documentation, please contact:
PROTEC GmbH & Co. KG
In den Dorfwiesen 14 | 71720 Oberstenfeld
Germany
Phone: (+ 4 ) 7062 – 2 55 0
Fax: (+ 4 ) 7062 – 2 55 60
E-Mail: [e-mail]
Internet: www.protec-med.com

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 3 von 44
Table of contents
Page
Table of contents ........................................................................................................................... 3
Revision Status .............................................................................................................................. 6
General Notes ................................................................................................................................ 7
Mechanical – Electric Warning .................................................................................................... 7
Radiation Warning ........................................................................................................................ 7
1 Device Description .............................................................................................................. 9
1.1 Introduction .........................................................................................................................................................................................
1.2 Description............................................................................................................................................................................................
1.2.1 System Components .........................................................................................................................................................
1.2.2 Hardware and Network System Requirements .................................................................................................
1.2.3 Installation ............................................................................................................................................................................. 10
1.2.3.1 Floor capacity ................................................................................................................................................................ 10
1.3 Performance Characteristics ................................................................................................................................................... 10
1.3.1 Radiographic table ........................................................................................................................................................... 10
1.3.2 X-ray tube support stand ............................................................................................................................................. 10
1.3.3 Image receptor floor stand.......................................................................................................................................... 11
1.4 Intended use ..................................................................................................................................................................................... 11
1.5 Clinical Benefit ................................................................................................................................................................................. 11
1.6 Patient Target Group(s) .............................................................................................................................................................. 11
1.7 Medical Conditions to be diagnosed ................................................................................................................................ 11
1.8 Indications and Contraindications ...................................................................................................................................... 12
1.8.1 Indications ............................................................................................................................................................................. 12
1.8.2 Contraindications .............................................................................................................................................................. 12
1. Intended User Group ................................................................................................................................................................... 12
1.10 Declaration of Conformity ........................................................................................................................................................ 12
2 Safet Instructions ............................................................................................................ 13
2.1 General Safety Instructions ...................................................................................................................................................... 15
2.1.1 Requirements for Operation ...................................................................................................................................... 15
2.1.2 Device Operation .............................................................................................................................................................. 15
2.1.2.1 Operating Type ............................................................................................................................................................ 15
2.1.3 Operating Personnel ....................................................................................................................................................... 15
2.1.4 Crushing and Collision Hazard .................................................................................................................................. 16
2.1.5 Explosion protection ....................................................................................................................................................... 16
2.1.6 Radiation Protection ........................................................................................................................................................ 16
2.1.7 Ventilation .............................................................................................................................................................................. 16
2.1.8 Interaction with Other Devices ................................................................................................................................. 16
2.1. Electromagnetic Environment and Influencing of Devices .................................................................... 16
3 Control Elements and Displa s ....................................................................................... 18
3.1 Main Switch of the X-ray system .......................................................................................................................................... 18
3.2 Emergency Stop Switches of the X-ray system ........................................................................................................... 1
3.2.1 Generator Emergency Stop Switch ........................................................................................................................ 1
3.3 Control elements and Display of PROGNOST F .......................................................................................................... 1
3.4 Control elements and Display of PROGNOST SH ....................................................................................................... 1
3.4.1 PROGNOST SH ..................................................................................................................................................................... 1
3.4.2 PROGNOST SH TOUCH ................................................................................................................................................... 20
3.4.3 Foot pedal .............................................................................................................................................................................. 21
3.5 Control elements and Display of collimator ................................................................................................................. 22
3.6 Control elements and Display of X-ray tube ................................................................................................................. 22
3.7 Control elements and Display of X-ray generator ..................................................................................................... 22
3.8 Control elements of Bucky, Grid entity ............................................................................................................................. 22
3. Control elements and Display of verticalX-ray system image receptor stand PROVERT ................... 23
3. .1 Vertical carriage .................................................................................................................................................................. 23

PRS 500 F Instructions for use 5067-0-8002
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3.10 Control elements and device displays of RAPIXX system ..................................................................................... 23
3.11 Control elements and device displays of CONAXX 2 .............................................................................................. 23
4 Handling / Operation ........................................................................................................ 24
4.1 Requirements before and during Operation ................................................................................................................ 24
4.2 Operation of the X-ray system ............................................................................................................................................... 24
4.2.1 Operation at the X-ray system table ...................................................................................................................... 24
4.2.1.1 Position of patients on the tabletop ............................................................................................................... 24
4.2.1.2 Setting the X-ray unit on the mid moving Bucky, Grid entity ......................................................... 24
4.2.1.3 Inserting a cassette into the cassette tray .................................................................................................... 24
4.2.1.4 Adjusting the focus-film distance (FFD) ........................................................................................................ 24
4.2.1.5 Adjusting the light resp. X-ray field .................................................................................................................. 24
4.2.1.6 Exposure preparation / exposure release .................................................................................................... 24
4.2.1.7 Overtable exposures ................................................................................................................................................. 25
4.2.1.8 Exposures with the lateral detector holder (optional) ......................................................................... 25
4.2.2 Operation at X-ray system image receptor stand PROVERT ................................................................... 26
4.2.2.1 Adjustment of the X-ray unit to the mid of a cassette or Bucky/Grid entity of aX-ray
system image receptor stand (vertical center beam) ................................................................................................. 26
4.2.2.2 Adjustment of the source to image-receptor distance (SID) ........................................................... 26
4.2.2.3 Adjustment of the light-/ radiation field....................................................................................................... 26
4.2.2.4 Exposure preparation/ release ............................................................................................................................ 26
4.3 Operation X-ray system table PROGNOST F.................................................................................................................. 26
4.4 Operation collimator ................................................................................................................................................................... 26
4.5 Operation X-ray tube ................................................................................................................................................................... 26
4.6 Operation X-ray generator ....................................................................................................................................................... 27
4.7 Operation Bucky, Grid entity ................................................................................................................................................... 27
4.8 Operation verticalX-ray system image receptor stand PROVERT ..................................................................... 27
4. Operation RAPIXX system......................................................................................................................................................... 27
4.10 Operation Software ...................................................................................................................................................................... 27
4.11 Function of the PRS 500 F......................................................................................................................................................... 27
4.11.1 Switching the PRS 500 F on and off ....................................................................................................................... 27
4.11.2 Dosimetric Calibration ................................................................................................................................................... 27
4.12 Automatic Exposure Control .................................................................................................................................................. 27
5 Safet and Maintenance ................................................................................................... 28
5.1 Introduction ...................................................................................................................................................................................... 28
5.2 Reusability .......................................................................................................................................................................................... 28
5.3 Cleaning and Disinfection ........................................................................................................................................................ 28
5.3.1 Cleaning .................................................................................................................................................................................. 28
5.3.2 Disinfection ........................................................................................................................................................................... 28
5.4 Inspection and maintenance ................................................................................................................................................. 2
5.4.1 Daily Monitoring before and during the Examination operation ....................................................... 2
5.4.2 Regular Monitoring .......................................................................................................................................................... 2
5.4.3 Maintenance ........................................................................................................................................................................ 2
5.4.4 Warranty .................................................................................................................................................................................. 2
5.4.5 Product Service Life ......................................................................................................................................................... 30
5.4.6 Further Information ......................................................................................................................................................... 30
5.4.7 Applied Parts and parts which get handled like an application part ................................................ 30
5.4.8 Disposal ................................................................................................................................................................................... 30
6 Power Suppl ..................................................................................................................... 31
6.1 Electromagnetic Compatibility (EMC) after EN 60601-1-2 ................................................................................... 31
6.1.1 Guidelines and Manufacturer’s Declaration – Electromagnetic interference .............................. 32
7 Technical Data .................................................................................................................... 35
7.1 Dimensions ........................................................................................................................................................................................ 35
7.2 X-ray system table PROGNOST F .......................................................................................................................................... 37
7.3 Bucky, Grid entity ........................................................................................................................................................................... 37
7.4 X-ray Tube Support Stand ........................................................................................................................................................ 38
7.5 Image Receptor Stand ................................................................................................................................................................ 38
7.6 Attenuation Equivalent .............................................................................................................................................................. 3

PRS 500 F Instructions for use 5067-0-8002
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7.6.1 Protection Art and Protection Class ....................................................................................................................... 3
7.7 Automatic Cut-off Dose ............................................................................................................................................................. 3
7.7.1 Analogue System .............................................................................................................................................................. 3
7.7.2 Digital System ...................................................................................................................................................................... 3
7.7.3 Digital System ...................................................................................................................................................................... 3
7.8 Environmental Conditions ....................................................................................................................................................... 3
7.8.1 Environmental conditions during operation ................................................................................................... 3
7.8.2 Environmental Conditions for Shipping and Storage ................................................................................ 3
8 Description of s mbols, labels and abbreviations ....................................................... 40
8.1 Symbols ............................................................................................................................................................................................... 40
8.2 Identification label......................................................................................................................................................................... 41
8.3 Labels .................................................................................................................................................................................................... 42
8.4 Position symbols and labels .................................................................................................................................................... 43
8.5 Abbreviations ................................................................................................................................................................................... 44

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 6 von 44
NOTE
The information contained in this document conforms to the configuration of the
equipment as of the date of manufacture. Revisions to the equipment subsequent
to the date of manufacture will be addressed in service updates distributed to the
PROTEC Technical Service Organization.
Revision Status
Revision Date Updated pages Comments Author
1.0 201 -05-14 all
New created, replaces
document 5087-0-0002
-
2.0 201 -07-31
Cap. 1.2, 1.7, 6.1.1, 8.1,
8.2, 8.4
GMDN terms updated
Changed optional
accessories and images
dimension
EMC tables removed
Symbols added
Identification label updated
-
3.0 2020-06-1 Cap. 1.2.2.1, 1.3.2, 3.2, 7.4 Telescopic arm added
-
4.0 2020-08-11 Front page, Cap. 5.3.3 Maintenance updated
-
5.0 2020-11-12
Cap. 1.2.1; Cap.6; Cap.
3.1.1; Cap. 3.1.2; Cap.
4.1.1.8
New generators, Rotatable
X-ray column added
-
6.0
2022-01-1 Titelseite, Kap. 3.2.3; Kap.
1.2.2; Kap. 1.2.2.1; Kap.
1.3.2; Kap. 7.1
Basis UDI-DI new; Note
Rotation; Note Installation
new; total weight changed;
ceiling height changed;
Traverse paths PROGNOST
SH changed vertically;
translation cpl. revised
ML

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 7 von 44
General Notes
WARNING!
In order to maintain the set and tested requirements of the 60601 series of
standards, the ME s stem must not be modified during its actual operating
life.
Mechanical – Electric Warning
WARNING!
All of the movable assemblies and parts of this equipment should be operated
with care and routinel inspected in accordance with the manufacturer's
recommendations contained in the equipment Accompan ing Documents.
Maintenance and service is onl to be performed b Customers authorized b
PROTEC GmbH & Co. KG.
Live electrical terminals are deadl .
Do not remove flexible high-tension cables from X-ra tube housing or high-
tension generator and/or access covers from X-ra generator.
For all components of the equipment protective earthing means must be
provided in compliance with the national regulations.
Failure to compl with the foregoing ma result in serious or fatal bodil
injuries to the operator or those in the area.
Radiation Warning
WARNING!
In these accompan ing documents, a s stem or a component for such a
s stem is documented, which is used for the intended generation of X-ra s in
medical diagnostics.
X-ra s are ionizing radiation that can cause damage to living organisms (e.g.
cancer or mutations).
X-ra s represent a potential risk for patients and emplo ees. Therefore, the
application of X-ra s with a given medical issue, must aim at the minimization
of radiation exposure for both groups of people.
The group of people responsible for the application must have the necessar
specialist knowledge in accordance with the ordinances and guidelines and
appl the procedures for the safe operation of such s stems.
The national regulations must also be observed during planning and
installation.
The X-ra s are created in the X-ra tube b strong braking of previousl
accelerated electrons, which emit energ in the form of electromagnetic
waves. The intensit depends on the set parameters voltage (kV), current
(mA) and time (s) on the X-ra generator. The X-ra s are onl emitted at a
radiation exit window of the tube and are limited b the collimator mounted
directl below.
The X-ra components from PROTEC used are onl devices for the human
medical diagnostic area, which can be set up to a maximum of 150 kV. Further
information can be found in the technical data inside the instructions for use
for the generators, X-ra tubes and collimators.

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 8 von 44
To the User
NOTE
The user of these accompanying documents is required to carefully read through
and carefully consider the instructions, warnings and cautions contained therein
before starting operation.
Even if you have already operated similar systems, changes in the design,
production and functional routine of the system described here may have been
made, which have a significant influence on the operation.
Although the product was subject to a risk analysis and the design corresponds to
the current state of the art, residual risks remain in clinical use. These are displayed in
the following Instructions for use by application limits, contraindications, warnings
and precautions.
Assembly and service works on the system described here must be carried out by
authorised and qualified personnel from PROTEC GmbH & Co. KG. Assembly
personnel and other persons who are not employees of the technical service
department of PROTEC GmbH & Co. KG are requested to contact the local branch of
PROTEC GmbH & Co. KG before assembly or service work is started.
For assembly and service works, it is necessary to use the "Technical Description” of
the product and to observe the points it contains.
NOTE
The use of the product with add-on or accessory parts not authorized by PROTEC or
other unapproved components is not permitted.

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany von 44
1 Device Description
1.1 Introduction
The instructions for use describe the performance characteristics and operation required for efficient
and effective use of the PRS 500 F.
Before working with the PRS 500 F, the complete instructions for use must be read, especially the Safety
Instructions and the chapter Handling.
1.2 Description
The PRS 500 F series radiography system is a complete and powerful easy-to-use bucky workplace
featuring high performance for the operator and a pleasant atmosphere for patients The complete
system delivers excellent image acquisition quality and is ideal for all types of X-ray examinations in
radiology centres, clinics and hospitals – regardless of whether analogue or digital imaging methods
are used.
1.2.1 S stem Components
The PROTEC X-ray system PRS 500 F consists of the following components:
•Stationary patient positioning table with floating tabletop
•X-ray tube support stand with control arm
•X-ray cassette holder (Bucky or Grid entity)
•Image receptor stand
•X-ray generator
•X-ray tube assembly with cover
•Anti-scatter grid
•Collimator
Optional Components
•Measuring chamber (ionisation or solid state),
•Dose area product meter
•Various DR systems (RAPIXX series, consisting of DR detector, Interface Box and CONAXX software)
Optional Accessories
The following optional accessories are available for the PRS 500 F X-ray system:
•Patient extending handle
•Compression band
•Mattress 225 cm x 70 cm x 2 cm
•Short hand grip
•Short hand grip adjustable
•Long hand grip
•Strain relief cable conduit image receptor stand
•Lateral detector holder (only in connection with the rotatable X-ray column PROGNOST SH)
•Accessories that can influence the EMC conditions
•Network cable (note the max. cable length in the component documentation)
•RAPIXX data connection cable (note the max. cable length in the component documentation)
•WLAN router or access points (only use devices approved by PROTEC).
1.2.2 Hardware and Network S stem Requirements
If it is an X-ray system with optional system components for digital use, it should be ensured that the
country-specific requirements for data protection and IT security are met.
The system requirements for the optional system components (RAPIXX series) can be found in the
current document supplied, "EN_5330-0-0026_CONAXX2_System requirements".

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 10 von 44
1.2.3 Installation
NOTE
The installation of the PRS 500 F must be performed by PROTEC service department
or a service company authorized by them.
This X-ray system PRS 500 F must be installed in a shielded X-ray room that complies with the national
regulations on radiation protection.
The room intended for the installation of the X-ray system must be prepared. This may need to include
changes to the routing of electrical connections to a central distribution cabinet. The electrical and
structural design of the room intended for the generator must comply with national regulations
(electrical and floor weight load).
For more information, please see separate “Installation manual” PRS 500 F.
Contact information of persons qualified to perform installations are available upon request at:
PROTEC GmbH & Co. KG
In den Dorfwiesen 14 | 71720 Oberstenfeld
Telephone: +4 (0) 7062 – 2 55 0
Fax: +4 (0) 7062 – 2 55 60
E-Mail: [e-mail]
Internet: www.protec-med.com
1.2.3.1 Floor capacit
NOTE
The X-ray system is primarily made of metal pieces. This has a corresponding effect
in the weight of the device.
The X-ray system PRS 500 F has a weight of 823 kg (incl. Generator),
Every technician is obliged to check the corresponding floor load before each
installation. Raised floors and hollow floors must also be considered.
1.3 Performance Characteristics
1.3.1 Radiographic table
•Floating tabletop
•Tabletop colour: white.
•Motor-operated tabletop brake for effortless patient positioning.
•Low optimised distance between the tabletop surface and the image receptor surface.
•Large adjustment range of the tabletop for positioning the patient.
•High reliability
•Side profile rails on the long sides of the tabletop for attaching accessories.
•Prepared for the installation of an X-ray cassette holder (Bucky or Grid entity) with anti-scatter
grid and a measuring chamber for operation with an automatic exposure control.
•Variable cassette / detector sizes can be used. Formats from 13 cm x 18 cm (5" x 7") to 43 cm x
43 cm (17" x 17"), depending on analogue or digital use.
•Suitable for a Bucky or a Grid entity (analogue or digital)
1.3.2 X-ra tube support stand
•Ceiling-free column stand intended for use within rooms with a ceiling height of at least 2.35 m
/ standard and 2.40 m / with rotation X-ray column.
•Wide range of application
•Small wall distance allows good use of space.

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 11 von 44
•Control elements on the command arm are handily placed.
•Reproducible position of the X-ray assembly when rotating around the support arm axis
through angle indicator.
•Vertical travel range, focus height from 2 .7 cm to 18 .6 cm with horizontal beam path
•Electromagnetic brakes for the longitudinal movement of the column stand, the vertical
movement of the support arm, for the rotation of the X-ray tube assembly around the support
arm axis +/-180° with additional 0 ° detents as well as for the transversal movement of the
support arm +230 mm (optional).
•Safety coupling for the automatic centring of the X-ray tube assembly with the X-ray cassette
holder (Bucky or Grid entity).
1.3.3 Image receptor floor stand
•Space-saving with a small footprint
•Wall and floor mounting or just floor mounting
•Left or right cassette loading
•Variable cassette / detector sizes can be used. Formats from 13 cm x 18 cm (5" x 7") to 43 cm x
43 cm (17" x 17"), depending on analogue or digital use.
•Suitable for a Bucky or a Grid entity (analogue or digital).
1.4 Intended use
The basic diagnostic X-ray systems of the PRS 500 series are intended for various routine applications in
planar X-ray imaging in human medicine.
They are stationary systems that can be used both for analogue and digital imaging.
1.5 Clinical Benefit
The clinical benefit of using diagnostic X-ray systems in human medicine is 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
A complete list of medical conditions that can be diagnosed is impossible for conventional
radiography, because the spectrum of conventional X-rays is very diverse and can vary in the course of
medical-technical progress.
Examples for medical conditions to be diagnosed:
•For the diagnosis of a bone fracture or bony injuries of the skeletal system or pathological
changes of hard tissues.
•For monitoring of correct reduction of bone fractures
•For the diagnosis of joint dislocations and ligament ruptures of the musculoskeletal system.
•For the diagnosis of degenerative, inflammatory, traumatic and tumorous diseases and
changes of the musculoskeletal 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).

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 12 von 44
1.8 Indications and Contraindications
1.8.1 Indications
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.
Accordingly, it is also described by the International Atomic Energy Agency (IAEA) in the document
Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards (Requirement
37: Justification of medical exposures). It also refers to the need to consider national or international
guidelines for the justification of a medical exposure.
NOTE
Even if, according to the justifying indication, the benefit predominates the radiation
risk, it must not be disregarded that there are residual risks due to ionising radiation
and that undesirable side effects may occur. Ionising radiation (X-radiation) can
damage the genome and, in the long term, lead to cancer and mutations and thus
damage the human body.
1.8.2 Contraindications
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 (see justification of medical exposures,).
For pregnant women and children it is important to consider if the exposure is really necessary. It
should be avoided if possible.
1.9 Intended User Group
The X-ray systems of the PRS 500 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 Conformit
This product is in conformity with the requirements of the European Community
Medical Device Directive 3/42/EEC from 06/14/1 3 including all current
revision standards.
The declaration of conformity is available directly from PROTEC:
PROTEC GmbH & Co. KG
In den Dorfwiesen 14 | 71720 Oberstenfeld
Telephone: +4 (0) 7062 – 2 55 0
Fax: +4 (0) 7062 – 2 55 60
E-Mail: [e-mail]
Internet: www.protec-med.com

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 13 von 44
2 Safet Instructions
NOTE
Contains information that must be observed during operation.
xxx
CAUTION!
Contains information which, if not observed, can cause property
damage.
xxx
WARNING!
Contains information which, if not followed, can cause personal
injury.
xxx
WARNING!
Warning of radioactive substances or ionizing radiation. Contains
information which, if not observed, can cause personal injury.
xxx
Settings and calibrations that are not described in these instructions for use must be carried out using
the technical description of the device by PROTEC service department or a service company authorized
by them.
NOTE
All instructions supplied with the X-ray system must be observed and the safety
instructions contained therein must be carefully read and adhered to.
NOTE
After the initial installation, the commissioning must be recorded with the PROTEC
acceptance protocol FB-04-07A4.
NOTE
In the case of a digital system, the instructions for CONAXX and RAPIXX must be
observed and the safety instructions contained therein must be carefully read and
adhered to.
NOTE
The X-ray system may only be commissioned if all safety measures for operator
protection have been met and checked. These protective measures can include
door contact, designated area, dosimeter, protective clothing, etc.

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 14 von 44
CAUTION!
The instructions for use contain all the information relevant to safet in order
to generall put the X-ra s stem into operation. The device ma onl be
operated b appropriatel trained and trained personnel. In this context,
operation is ensured b clear s mbols on the control elements. All further
information and instructions can be found on the supplied data carrier (USB,
CD or DVD). This information applies in its entiret as an appendix to these
instructions for use and must be observed
NOTE
All control elements are marked with clear symbols on the control console and on
the swivel arm or the image receptor stand, which are described again in detail in
the corresponding instructions for use. The legal requirements regarding the
building regulations for an X-ray area must be met. The X-ray system must be tested
in accordance with the regulations in force in the country of installation and
approved by the appropriate body.
CAUTION!
If the wrong SID is set for an exposure, it can have a damaging effect on the
patient. The inverse square law applies. Halving the distance leads to a
radiation dose that is four times higher.
WARNING!
X-ra s ma not be performed on persons without a medical justif ing
indication. In the case of pregnant women and children, it must be carefull
considered whether an exposure is necessar . It should be avoided if possible.

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 15 von 44
2.1 General Safet Instructions
2.1.1 Requirements for Operation
WARNING!
The PRS 500 F is a protection class I device (according to EN 60601-1).
To avoid the risk of an electric shock, this device ma onl be connected to a
suppl network with a protective earthing conductor.
The power suppl for the PRS 500 F of the X-ra s stem is exclusivel made b
direct connection to the X-ra generator or the Power Box and is permanentl
connected there. The X-ra generator or the Power Box must have at least 2
connections for 230V 50/60Hz.
The X-ra generator of the X-ra s stem is connected to the suppl network
(see technical description of the X-ra generator).
To reduce the risk of electric shock, the s stem must be connected to a suppl
network with protective earthing.
The s stem does not have an on/off switch. It is switched on or off directl b
switching on the X-ra generator or b the switch on the Power Box. In order
to separate an electrical voltage from the X-ra s stem, the connected X-ra
generator or the Power Box must be switched off.
2.1.2 Device Operation
In case of a malfunction, do not use the PRS 500 F anymore and notify PROTEC service department or a
service company authorized by them.
2.1.2.1 Operating T pe
The PRS 500 F is not intended for continuous operation.
The separate maximum operating times must be taken from the individual components.
Duty Cycle: S3 15% - maximum continuous operation of 1,5 minutes.
2.1.3 Operating Personnel
NOTE
Only trained and authorized personnel are allowed to work on the PRS 500 F.
NOTE
The operating personnel must be familiar with all warning signs attached to the PRS
500 F. They are used for your own safety and that of others and ensure proper
operation.

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 16 von 44
2.1.4 Crushing and Collision Hazard
WARNING!
It must be ensured that when operating the moving parts of PRS 500 F, no
persons or objects are in the obvious danger area of the device. If not
observed, it can result in personal injur or damage to the PRS 500 F or other
objects.
2.1.5 Explosion protection
These PRS 500 F is not designated for use within areas with explosive hazards.
2.1.6 Radiation Protection
X-rays can pose a risk to patients and other people if the regulations for the operation of such systems
are not observed.
For this reason, the principles of radiation protection must have top priority and must be strictly
adhered to:
•Keeping distance from the radiation source
The dosage is reduced as a factor of the square of the distance from a (dot shaped) radiation source.
Double the distance ¼ dose, triple the distance 1/ dose, etc.
The dose decreases with the square of the distance from a (point) radiation source, i.e. double
distance 1/4 dose, triple distance 1/ dose, etc.
•Keeping exposure time as short as possible
The longer the exposure time, the higher the dose, i.e. halving the exposure time leads to halving
the dose, etc.
•Utilize shielding and protective clothing
The protection value increases exponentially with the thickness of the shielding, i.e. 2 half-value
layers weaken a (homogeneous) radiation to 1/4, 3 half-value layers to 1/8 and 10 half-value layers
to less than 1/1000 of the initial value.
•Do not reach into the direct X-Ra beam
The dose in the non-attenuated direct beam is about 100 times greater than that in the area of
scattered radiation.
•Utilize personal dosimeters
When working with radiation, dosimeters should be used for monitoring that are appropriate for the
activity.
The X-Ray exposures are principally triggered from behind a protective wall. When taking exposures
near the genital organs use the maximum available protection (e.g. gonad protectors or lead covers).
Persons who have to be in the vicinity of the patient must wear protective clothing (e.g. lead aprons).
The same applies to maintenance and repair work.
2.1.7 Ventilation
It must be ensured that the air exchange from the X-Ray generator in the system is not hindered. The
ambient air temperature must not exceed 40 °C.
2.1.8 Interaction with Other Devices
Interactions with other devices are not known.
2.1.9 Electromagnetic Environment and Influencing of Devices
CAUTION!
The use of other accessories, other converters and other cables than those
specified b PROTEC or provided in the documentation of the component
manufacturer can result in increased electromagnetic interference or reduced
electromagnetic immunit of the device and lead to defective operation.

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 17 von 44
CAUTION!
The use of the PRS 500 F immediatel next to other devices or with other
devices in a stacked form should be avoided, as this could result in defective
operation. If use in the manner described above is nevertheless necessar , the
PRS 500 F and the other devices should be observed to ensure that the are
working properl .
NOTE
The properties of this device, determined by emissions, allow its use in industrial
areas and in hospitals (CISPR 11, class A). When used in residential areas (for which
class B is usually required by CISPR 11), this device may not provide adequate
protection for radio services. The user may need to take remedial measures such as
relocating or realigning the device.
The PRS 500 F is intended for use in an environment in professional health care facilities (e.g. clinics,
surgery centres, physiology practices ...)

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 18 von 44
3 Control Elements and Displa s
3.1 Main Switch of the X-ra s stem
The PRS 500 F is switched on and off via a mini console (e.g. of the Venus-32/50-R, see Fig. 3.1a), a
normal control console (e.g. of the Venus-32/50-R, see Fig. 3.1b) of the X-ray generator or via the switch
on the Power Box (see Fig. 3.1c).
The illustrations of the mini and operating console may differ depending on the system configuration.
However, the symbols for switching on or off are identical.
A Switching off the PRS 500 F
B Switching on the PRS 500 F
C Ready for exposure
D Radiation indicator
A Switching off the PRS 500 F
B Switching on the PRS 500 F
C Ready for exposure
D Radiation indicator
OFF Switching off the PRS 500 F
ON Switching on the PRS 500 F
Fig. 3.1a Mini console Venus-32/50-R
Fig. 3.1c Power Box
Switch
Fig. 3.1b Control console Venus-32/50-R
A
B
C
D

PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 1 von 44
3.2 Emergenc Stop Switches of the X-ra s stem
The PRS 500 F has the following emergency stop switches, which can be used to bring the device to an
immediate standstill and disconnect it from the power supply.
3.2.1 Generator Emergenc Stop Switch
For the switch position of the corresponding X-ray generator, please refer to the enclosed PRS 500 F
instructions for use.
3.3 Control elements and Displa of PROGNOST F
Detailed information please find in the accompanying User Manual of the PROGNOST F.
3.4 Control elements and Displa of PROGNOST SH
3.4.1 PROGNOST SH
1 Angle indicator for adjusting the X-ray assembly
2 Brake release for horizontal movement of the X-ray floor stand
3 Brake release for rotational movement of the X-ray unit around the horizontal support arm axis
4 Brake release for vertical movement of X-ray tube arm and horizontal movement of X-ray floor stand
5 Brake release for vertical movement of X-ray tube arm and horizontal movement of X-ray floor stand
6 Brake release for movement of X-ray tube assembly around the horizontal support arm axis
7 Brake release for vertical movement of X-ray tube arm
8 Option: Brake release for transversal movement of X-ray tube arm (+230mm)
9 Option: Status-LED orange (if LED is on: X-ray tube arm is not engaged)
10 Option: Status-LED red (if LED on: X-ray flor stand is not engaged)
WARNING!
If the red LED on the right membrane ke pad lights up, the X-ra tube carrier
is not engaged! In this state no x-ra s ma be taken. The X-ra tube carrier
must first engage in one of the positions (0 / ± 90° / ± 180°)!
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PRS 500 F Instructions for use 5067-0-8002
PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 20 von 44
3.4.2 PROGNOST SH TOUCH
1 Touchdisplay of X-ray tube assembly
2 Brake release for horizontal movement of X-ray floor stand
3 Brake release for movement of X-ray tube assembly around the horizontal support arm axis
4 Brake release for vertical movement of X-ray tube arm and horizontal movement of X-ray floor stand
5 Brake release for vertical movement of X-ray tube arm and horizontal movement of X-ray floor stand
6 Brake release for movement of X-ray tube assembly around the horizontal support arm axis
7 Brake release for vertical movement of X-ray tube arm
8 Option: Brake release for transversal movement of X-ray tube arm (+230mm)
9 Option: Status-LED orange (if LED is on: X-ray tube arm is not engaged)
10 Option: Status-LED red (if LED on: X-ray flor stand is not engaged)
WARNING!
If the red LED on the right membrane ke pad lights up, the X-ra tube carrier
is not engaged! In this state no x-ra s ma be taken. The X-ra tube carrier
must first engage in one of the positions (0 / ± 90° / ± 180°)!
Operation is from the front (operating side) of the X-ray head.
If the operating unit is equipped with handles, the electromagnetic lock of one or more movements
can be released by thumb pressure on the keys of the operating unit and the tube head can be
brought into the desired position.
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