Pro-tec PRS 500 C User manual

PROTEC GmbH & Co. KG
In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
Telephone: [phone] E-Mail: [email protected]
Version: 5.0
Issued: 2021-11-24
Subject to alterations
PRS 500 C
Basic diagnostic X-ray syst m
Mod l/ID: 7073-9-8050
Basis-UDI-DI: 426050264X002ZD
Instructions for us
Ident. No. 5073-0-3002

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 other or other use is prohibited without
the express written authorization of PROTEC´s law department. Report any
violations of this requirement to PROTEC GmbH & Co. KG.
© 2021 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
Phon : (+ 49) 7062 – 92 55 0
Fax: (+ 49) 7062 – 92 55 60
E-Mail: prot c@prot c-m d.com
Int rn t: www.prot c-m d.com

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
3 von 3
Tabl of cont nts
Pag
Tabl of cont nts ........................................................................................................................... 3
Docum nt Eff ctivity .................................................................................................................... 6
G n ral Not s ................................................................................................................................ 7
M chanical – El ctric Warning .................................................................................................... 7
Radiation Warning ........................................................................................................................ 7
To th Us r ..................................................................................................................................... 8
1 Product d scription ............................................................................................................ 9
1.1 Introduction .........................................................................................................................................................................................
1.2 Description............................................................................................................................................................................................
Equipment components .................................................................................................................................................
Hardware and network system requirements ....................................................................................................
Installation ............................................................................................................................................................................. 10
1.2.3.1 Floor loading capacity .............................................................................................................................................. 10
1.3 Performance characteristics .................................................................................................................................................... 10
Patient positioning table .............................................................................................................................................. 10
Floor-guided tube column stand ............................................................................................................................ 10
Vertical Bucky Wall 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 Indication and Contraindication .......................................................................................................................................... 11
Indications ............................................................................................................................................................................. 11
Contraindications .............................................................................................................................................................. 12
1. Intended Operator Group ........................................................................................................................................................ 12
1.10 Declaration of Conformity ........................................................................................................................................................ 12
2 Saf ty Instructions ............................................................................................................ 13
2.1 General safety instructions ....................................................................................................................................................... 15
Requirements for operation ....................................................................................................................................... 15
Device operation ............................................................................................................................................................... 15
2.1.2.1 Operating type ............................................................................................................................................................. 15
Operating personnel ....................................................................................................................................................... 15
Crushing and Collision Hazards ................................................................................................................................ 15
Explosion Protection ....................................................................................................................................................... 15
Radiation Protection ........................................................................................................................................................ 15
Ventilation .............................................................................................................................................................................. 16
Interaction with Other Devices ................................................................................................................................. 16
Electromagnetic Environment and Influencing of Devices .................................................................... 16
3 Control El m nts and Displays ....................................................................................... 18
3.1 Main Switch of the PRS 500 C ................................................................................................................................................ 18
3.2 Emergency Stop Switch of the PRS 500 C ...................................................................................................................... 18
Emergency Stop Switch Generator ........................................................................................................................ 18
3.3 Floor-guided tube column stand ........................................................................................................................................ 1
3.4 Patient positioning table ........................................................................................................................................................... 20
3.5 Vertical Bucky Wall Stand .......................................................................................................................................................... 20
3.6 Control elements and device displays PROGNOST C .............................................................................................. 21
3.7 Control elements and device displays Ralco R302 ................................................................................................... 21
3.8 Control elements and device displays Claymount Optica 20 ............................................................................ 21
3. Control elements and device displays VAREX RAD 14 ........................................................................................... 21
3.10 Control elements and device displays VAREX RAD 21 ........................................................................................... 21
3.11 Control elements and device displays IAE X76 ........................................................................................................... 21
3.12 Control elements and device displays Neusoft Venus ........................................................................................... 21

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
4 von 3
3.13 Control elements of Bucky, Grid Entity ............................................................................................................................. 21
3.14 Control elements and device displays of RAPIXX system ..................................................................................... 21
3.15 Control elements and device displays of CONAXX 2 .............................................................................................. 21
4 Handling ............................................................................................................................. 22
4.1 Requirements before and during Operation ................................................................................................................ 22
4.2 Operation of the PRS 500 C ..................................................................................................................................................... 22
Releasing the table top brake (positioning the table top) ....................................................................... 22
Positioning the image receptor from the wall stand .................................................................................. 22
Exposures with the basic diagnostic X-ray system ....................................................................................... 22
4.2.3.1 Positioning/descending of the patient on/from the table top ...................................................... 22
4.2.3.2 Setting the X-ray unit on the centre of the Bucky, Grid Entity ........................................................ 22
4.2.3.3 Inserting a cassette into the cassette tray .................................................................................................... 22
4.2.3.4 Adjustment of the focus-film distance (SID) .............................................................................................. 22
4.2.3.5 Adjusting the light-/beam field.......................................................................................................................... 22
4.2.3.6 Exposure preparation / Exposure releasing ................................................................................................ 23
4.2.3.7 Exposure with cassette on the table top ...................................................................................................... 23
Operation at the wall stand ........................................................................................................................................ 23
4.2.4.1 Adjustment of the X-ray unit to the centre of a cassette or Bucky/Grid Entity of an X-ray
system wall stand (vertical centre beam) ........................................................................................................................... 23
4.2.4.2 Adjustment of image-receptor distance (SID) .......................................................................................... 23
4.2.4.3 Adjustment of the light-/ radiation field....................................................................................................... 23
4.2.4.4 Exposure preparation/ Exposure release ...................................................................................................... 23
Operation RALCO R302 ................................................................................................................................................. 23
Operation Optica 20 ........................................................................................................................................................ 23
Operation Neusoft Venus ............................................................................................................................................. 24
Operation Bucky, Grid Entity ...................................................................................................................................... 24
Operation VAREX RAD 14, RAD 21, IAE X76 ...................................................................................................... 24
Operation RAPIXX system ............................................................................................................................................ 24
Operation CONAXX 2 ..................................................................................................................................................... 24
4.3 Function of the PRS 500 C ........................................................................................................................................................ 24
Switching the PRS 500 C on and off ...................................................................................................................... 24
Power Box .............................................................................................................................................................................. 25
Dosimetric Calibration ................................................................................................................................................... 25
4.4 Exposure automatic ..................................................................................................................................................................... 25
5 Saf ty and Maint nanc ................................................................................................... 26
5.1 Introduction ...................................................................................................................................................................................... 26
5.2 Reusability .......................................................................................................................................................................................... 26
5.3 Cleaning and Disinfection ........................................................................................................................................................ 26
Cleaning .................................................................................................................................................................................. 26
Disinfection ........................................................................................................................................................................... 27
5.4 Inspection and maintenance ................................................................................................................................................. 27
Daily monitoring prior and during the examination operation ........................................................... 27
Regular monitoring .......................................................................................................................................................... 27
Maintenance ........................................................................................................................................................................ 27
Warranty .................................................................................................................................................................................. 28
Product Service Life ......................................................................................................................................................... 28
Further Information ......................................................................................................................................................... 28
Applied Parts and Parts Considered as Applied Parts ................................................................................. 28
Disposal ................................................................................................................................................................................... 28
6 El ctrical data ..................................................................................................................... 29
6.1 Electromagnetic Compatibility (EMC) according to EN 60601-1-2 ................................................................ 2
Guidelines and Manufacturer’s Declaration – Electromagnetic Interference .............................. 30
7 T chnical Data .................................................................................................................... 33
7.1 Dimensions ........................................................................................................................................................................................ 33
7.2 Patient positioning table ........................................................................................................................................................... 35
7.3 Bucky unit ........................................................................................................................................................................................... 35
7.4 X-ray stem tube support, floor stand ................................................................................................................................. 35

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
5 von 3
7.5 Vertical X-ray system image receptor stand .................................................................................................................. 35
7.6 Attenuation Equivalent .............................................................................................................................................................. 36
Protection Type and Protection Class .................................................................................................................. 36
7.7 Automatic cut-off dose .............................................................................................................................................................. 36
Analogue system ............................................................................................................................................................... 36
Digital system ...................................................................................................................................................................... 36
7.8 Environmental ................................................................................................................................................................................. 36
Environmental conditions during operation ................................................................................................... 36
Environmental conditions for shipping and storage .................................................................................. 36
8 D scription of symbols, lab ls and abbr viations ....................................................... 37
8.1 Symbols ............................................................................................................................................................................................... 37
Generator; Tube; collimator and optional accessories ............................................................................... 38
8.2 Type label ........................................................................................................................................................................................... 38
8.3 Labels .................................................................................................................................................................................................... 38
8.4 Position of the signs and the labels .................................................................................................................................... 3
8.5 Abbreviations ................................................................................................................................................................................... 3

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
6 von 3
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.
Docum nt Eff ctivity
R vision No. Dat List of ff ctiv
pag s Comm nts Author
1.0 2020-11-12 all Original issue
2.0 2021-02-17 7, 23 Radiation Warning, Power Box
3.0 2021-02-25 Front Page, 10, 14,
18, 21, 24, 30, 34
Product picture, Warning
mattress, mattress at
characteristic table added,
symbols and labels, cleaning,
mattress added to technical
data table
4.0 2021-03-11
, 10, 25, 26, 27,
28, 31, 32, 33, 34,
35
X-ray mattress description,
compatible components, note
X-ray mattress at characteristic
table, Cleaning, disinfection,
Life time, Applied part, symbols
and labels, chapter power
supply connection, X-ray
mattress changed at technical
data table, note attenuation
equivalent
5.0 2021-11-24
Front page, 10, 11,
12, 13, 14 ,15, 16,
18, 1 , 20, 21, 22,
23, 24, 25, 27, 28,
2 , 31, 32, 33, 34,
35, 36, 37, 38, 3 ,
40
Product picture changed, X-ray
mattress removed, Chap. 1
Product description revised,
Chap. 2 Safety Instructions
revised, Chap. 2.1.2.1 Mode of
operation added, Chap. 3
control elements & device
displays revised, Chap. 4
Handling / Operation revised,
Chap. 5 Safety Maintenance
revised, Chap. 6.2
electromagnetic compatibility
revised, Chap. 7 Technical Data
revised, Chap. 8 Description
Symbols & Labels revised
MB

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
7 von 3
G n ral Not s
WARNING!
In ord r to maintain th s t and t st d r quir m nts of th 60601 s ri s of
standards, th ME syst m must not b modifi d during its actual op rating
lif .
M chanical – El ctric Warning
WARNING!
All of th movabl ass mbli s and parts of this quipm nt should b op rat d
with car and routin ly insp ct d in accordanc with th manufactur r's
r comm ndations contain d in th quipm nt accompanying docum nts.
Maint nanc and s rvic is only to b p rform d by custom rs authoriz d by
PROTEC GmbH & Co. KG.
Liv l ctrical t rminals ar d adly.
Do not r mov fl xibl high-t nsion cabl s from X-ray tub cov r or high-
t nsion g n rator and/or acc ss cov rs from X-ray g n rator.
For all compon nts of th quipm nt prot ctiv arthing m ans must b
provid d in complianc with th national r gulations.
Failur to comply with th for going may r sult in s rious or fatal bodily
injuri s to th op rator or thos in th ar a.
Radiation Warning
WARNING!
Th compon nt or syst m d scrib d within this docum nt is part of a syst m
for th int nd d g n ration of X-rays for m dical diagnosis.
X-rays ar ionizing radiation that can caus damag to living organisms ( .g.,
canc r or mutations).
X-rays g n rat a pot ntial risk for both pati nts and op rators. Th r for ,
th application of X-rays for a giv n m dical issu , must aim at th
minimization of radiation xposur for both groups of p opl .
Th p rsons r sponsibl for th application must hav th n c ssary
xp rtis in accordanc with th l gal r gulations and r quir m nts and
apply th proc dur s for th saf op ration of such syst ms. National
r gulations must also b obs rv d during planning and installation.
X-rays ar g n rat d in th X-ray tub by strong d c l ration of pr viously
acc l rat d l ctrons, which mits n rgy in th form of l ctromagn tic
wav s. Th int nsity d p nds on th s t param t rs of voltag (kV), curr nt
(mA) and tim (s) at th X-ray g n rator. Th X-rays ar mitt d only at a
b am xit window of th tub and ar limit d by th collimator mount d
dir ctly b low.
Th X-ray compon nts us d by PROTEC ar d vic s only for human m dical
diagnostic applications and can b adjust d up to a maximum of 150 kV.
Furth r information can b found in th r sp ctiv t chnical data of th
op rating instructions of th g n rators, X-ray tub s and collimators.

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
8 von 3
To th Us r
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 usage of the product in combination with accessories not authorized by
PROTEC is forbidden.

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
von 3
1 Product d scription
1.1 Introduction
This instructions for use describe the performance characteristics and operational aspects, required for
efficient and effective use of the PRS 500 C radiographic system.
Prior to working with the basic diagnostic X-ray system PRS 500 C, the entire operating instructions
must be read through, in particular the safety instructions and the chapter “Handling”.
1.2 D scription
The PRS 500 C X-ray system is a complete radiography system for versatile applications and high
workloads. The stationary X-ray system table with floating table top supports patient loads up to 250
kg. The complete system provides excellent image acquisition quality and is ideally suited for all types
of X-ray examinations in radiology practices, centres, clinics and hospitals – regardless of whether
analogue or digital imaging methods are used.
Equipm nt compon nts
The PROTEC X-ray system PRS 500 C persists of the following system components:
•Stationary patient positioning table with floating table top,
•Floor railed tube column with control arm,
•Bucky unit,
•Vertical Bucky Wall stand,
•X-ray generator VENUS-series,
•X-ray tube assembly with housing,
•Anti-scatter grid
•Collimator
Optional compon nts
•Measuring chamber (Solid State)
•Dose area product meter system
•Different direct X-ray-systems (RAPIXX-series)
(consisting of DR-detector, Interface Box, and Software)
Optional acc ssori s
The PRS 500 C can be equipped or customized with the following accessories:
•Patient extending handle
Acc ssori s that might aff ct th l ctromagn tic compatibility
•Network cable (note the max. length in the documents)
•RAPIXX data cable (note the max. length in the documents)
•WLAN-Router or Access Point (only use devices that has an authorization by PROTEC)
Hardwar and n twork syst m r quir m nts
If an X-ray system with optional system components for digital use is involved, 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".

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
10 von 3
Installation
NOTE
The installation of the PRS 500 C must be performed by PROTEC customer service
department or a service authorized by them.
This X-ray system PRS 500 C must be installed in a shielded X-ray room, which complies with national
radiation protection regulations.
The room intended for the installation of the X-ray system must be prepared.
This may need to include modifications for laying 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 loading).
For more information, please see separate “Installation manual” of the PRS 500 C.
Contact information of persons qualified to perform installations are available upon request from:
PROTEC GmbH & Co. KG
In den Dorfwiesen 14 | 71720 Oberstenfeld
Germany
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 loading capacity
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 C has a weight of 665 kg (incl. generator).
Every technician is obliged to check the floor loading capacity. Also raised floors and
hollow floors must be taken into account.
1.3 P rformanc charact ristics
Pati nt positioning tabl
•Floating table top
•Table top colour – white
•Electromagnetic table top brake for effortless patient positioning
•Low optimized distance between the table top surface and the film (detector) surface
•Large adjustment range of the table top for position of the patient
•High reliability
•Prepared for the installation of a Bucky with anti-scatter grid and 3-field measuring chamber
intended for the use with automatic exposure control
•Useable for variable cassette/detector sizes. 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.
Floor-guid d tub column stand
•Ceiling-free column stand intended for use within rooms with a ceiling height of at least 2.20
meters
•Wide range of application
•Small wall distance allows good space utilization

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
11 von 3
•Control elements of the control unit are well placed and easy to activate
•Reproducible positioning of the X-ray tube assembly when rotating around the tube arm axis
by angle indication
•Vertical range of travel of the focus height from 40.0 cm up to 176.5 cm during horizontal
beam projection
•Electromagnetic brakes for the longitudinal movement of the column stand, the vertical
movements of the carrying arm, the rotational movements of the X-ray tube assembly around
the axis of the carrying arm +/-135°.
•Safety connector for automatically centring the X-ray tube assembly and the Bucky.
V rtical Bucky Wall Stand
•Space saving with minimal installation area
•Wall – floor mounting of only floor mounting
•cassette loading from the right or left side
•Useable for variable cassette/detector sizes. 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.
1.4 Int nd d Us
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 for both
analogue and digital imaging. They are stationary systems that can be used for both analogue and
digital imaging.
1.5 Clinical B n fit
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 Pati nt Targ t 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 M dical Conditions to b diagnos d
A complete list of indications is not feasible 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:
•Bone fracture or bony injuries of the skeletal system or pathological changes of bony tissues.
•Monitoring of the correct setting of the fractures
•Dislocations and bony ligament ruptures of the musculoskeletal system
•Degenerative, inflammatory, traumatic and tumorous diseases and changes of the
musculoskeletal system.
•Defective position and malformations of the skeletal system.
•Thoracic and pulmonary symptoms (thorax exposures)
•Sclerosis
•Inflammatory and expansive processes of the mucosa, cranial bones and paranasal sinus
extension.
•Disease of the abdominal cavity (e.g. acute abdomen, abdominal overview radiography,
urethrogram, cystogram).
1.8 Indication and Contraindication
Indications
Justifying indication

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
12 von 3
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 a basic diagnostic X-ray 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.
Contraindications
There are no absolute contraindications for conventional X-rays.
However, only medically indicated exposures may be performed on persons (see Justification
Indication).
For pregnant women and children, it is important to consider if the exposure is really necessary. It
should be avoided if possible.
1.9 Int nd d Op rator Group
The radiographic systems of the PRS 500-series are exclusively designated for use by professional who
are trained, in accordance with the corresponding national regulations, in the use of diagnostic X-Ray
equipment and who have been instructed in the proper handling, application and operation as well as
in the permissible connection with other medical products, objects and accessories.
1.10 D claration of Conformity
This product is in conformity with the requirements of the Council Directive
3/42/EEC of 06/14/1 3 concerning medical devices, including all applicable
corrigenda.
The declaration of conformity is available upon request from:
PROTEC GmbH & Co. KG
In den Dorfwiesen 14 | 71720 Oberstenfeld
Germany
Telephone: +4 (0) 7062 – 2 55 0
Fax: +4 (0) 7062 – 2 55 60
E-Mail: [e-mail]
Internet: www.protec-med.com

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
13 von 3
2 Saf ty 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 PRS 500 C 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
For the implementation of the digital system the CONAXX and RAPIXX installation
manuals have to be read and the containing safety notes have to be observed.
NOTE
The PRS 500 C 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.
CAUTION!
Th instructions for us contain all th information r l vant to saf ty in ord r
to g n rally put th PRS 500 C into op ration. Th d vic may only b
op rat d by appropriat ly train d and train d p rsonn l. In this cont xt,
op ration is nsur d by cl ar symbols on th control l m nts. All furth r
information and instructions can b found on th suppli d data carri r (USB,

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
14 von 3
CD or DVD). This information appli s in its ntir ty as an app ndix to th s
instructions for us and must b obs rv d
NOTE
All operating elements are marked on the operating console and on the swivel arm
or wall stand with clear symbols which are described 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 th wrong SID is in us for xposur s, it can r sult in p rsonal injuri s for
th pati nt. Th inv rs squar law appli s h r . Halving th distanc will
caus a radiation dos 4 tim high r.
WARNING!
No xposur s of p rsons that ar not m dically indicat d may b p rform d.
In th cas of pr gnant wom n and childr n, strong consid ration must b
giv n to wh th r an xposur is n c ssary. If possibl , it should b avoid d.

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
15 von 3
2.1 G n ral saf ty instructions
R quir m nts for op ration
WARNING!
Th PRS 500 C is a prot ction class I d vic (according to EN 60601-1).
To avoid th risk of an l ctric shock, this d vic may only b conn ct d to a
supply n twork with a prot ctiv arth conductor.
Th pow r supply for th compon nts of th PRS 500 C X-ray syst m is
stablish d xclusiv ly by dir ct conn ction to th X-ray g n rator or th
Pow r Box and is p rman ntly conn ct d th r . Th X-ray g n rator or th
Pow r Box must hav at l ast 2 conn ctions for 230V 50/60Hz.
Th X-ray g n rator of th X-ray syst m is conn ct d to th pow r supply (s
T chnical D scription of th X-ray g n rator).
To r duc th risk of l ctric shock, th syst m must b conn ct d to a supply
n twork with prot ctiv grounding.
Th syst m has no on/off switch. It is switch d on and off dir ctly by switching
on th X-ray g n rator or by th switch on th pow r box. To disconn ct any
l ctrical voltag s from th X-ray syst m, th conn ct d X-ray g n rator or
th pow r box must b switch d off.
D vic op ration
In the event of malfunctions, the PRS 500 C X-ray system must no longer be used and PROTEC's
customer service department or a service department authorized by PROTEC must be notified.
2.1.2.1 Op rating typ
The PRS 500 C is not designated for continuous use.
The separate maximum operating times must be taken from the individual components.
Op rating p rsonn l
NOTE
Only trained and authorized personnel are allowed to work on the PRS 500 C.
NOTE
The operating personnel must be familiar with all warning signs attached to the PRS
500 C. They are used for your own safety and that of others and ensure proper
operation.
Crushing and Collision Hazards
WARNING!
Ensur that no p rsons or obj cts find th ms lv s in th obvious dang r zon
of th X-ray syst m wh n op rating th moving parts of th syst m. Failur to
do so may r sult in bodily injury to p rsons or damag to th X-ray syst m or
oth r obj cts.
Explosion Prot ction
The radiographic system PRS 500 C is not designated for use within areas with explosive hazards.
Radiation Prot ction
X-ray radiation can pose a hazard to patients and other people if the regulations regarding the
operation of X-ray systems are not followed.

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
16 von 3
For this reason, the basic principles of radiation protection must have the highest priority and must be
followed without exception:
•Distanc from th radiation sourc
The dosage is reduced as a factor of the square of the distance from a (dot shaped) radiation source,
which means double the distance ¼ dose, triple the distance 1/ dose etc.
•K p th xposur tim short
The longer the exposure time, the greater the dose, which means half the exposure time results in
half the dose etc. (applies especially to fluoroscopies; for X-ray images, the exposure value (mAs) is
given).
•Utiliz shi lding and prot ctiv clothing
The protective value grows exponentially with the thickness of the shielding, which means two half-
value layer thickness (HVL) attenuate (homogeneous) radiation to ¼, 3 HVL to 1/8 and 10 HVL to less
than 1/1000 of the original value.
•Do not r ach into th dir ct X-Ray b am
The dosage in beam, which is not attenuated, is around 100 times higher than that in the scattered
radiation.
•Us p rsonal dosag m t rs
In working with radiation (X-Rays), the use of personal dosage monitors is suggested.
The X-Ray images are principally triggered from behind a protective wall. For the creation of images
near the reproductive organs use the maximum available protection (e.g. gonadal protection or lead
rubber covers).
People who must remain close to the patient are required to wear protective clothing (e.g. lead gown).
This also applies for maintenance and installation work.
V ntilation
It is important to ensure that the air exchange of the X-Ray generator within the system is not hindered.
The ambient air temperature is not allowed to exceed 40°C.
Int raction with Oth r D vic s
Interaction with external devices is not known.
El ctromagn tic Environm nt and Influ ncing of D vic s
CAUTION!
Th us of oth r acc ssori s, oth r conv rt rs and oth r cabl s than thos
sp cifi d by PROTEC or provid d in th docum ntation of th compon nt
manufactur r can r sult in incr as d l ctromagn tic int rf r nc or r duc d
l ctromagn tic immunity of th d vic and l ad to d f ctiv op ration.
CAUTION!
Th us of th PRS 500 C imm diat ly n xt to oth r d vic s or with oth r
d vic s in a stack d form should b avoid d, as this could r sult in d f ctiv
op ration. If us in th mann r d scrib d abov is n v rth l ss n c ssary, th
PRS 500 C and th oth r d vic s should b obs rv d to nsur that th y ar
working prop rly.
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.

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
17 von 3
The PRS 500 C is intended for use in an environment in professional health care facilities (e.g., clinics,
surgery centres, physiology practices ...).

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
18 von 3
3 Control El m nts and Displays
3.1 Main Switch of th PRS 500 C
The PRS 500 C 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 consoles may differ depending on the system configuration.
However, the symbols for switching on or off are identical.
3.2 Em rg ncy Stop Switch of th PRS 500 C
The X-ray system PRS 500 C has no emergency stop switches, which can be used to bring the device to
an immediate standstill and disconnect it from the power supply.
Em rg ncy Stop Switch G n rator
For the emergency stop switch position of the corresponding X-ray generator, please refer to the
enclosed generator instructions for use.
A Switching off the PRS 500 C
B Switching on the PRS 500 C
C Ready for radiation
D Radiation reading
A Switching off the PRS 500 C
B Switching on the PRS 500 C
C Ready for radiation
D Radiation reading
OFF Switching off the PRS 500 C
ON Switching on the PRS 500 C
Fig. 3.1a Mini-console Venus-32/50-R
Fig. 3.1c Power Box Switch
Fig. 3.1b Operating console Venus-32/50-R
A
B
C
D

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
1 von 3
3.3 Floor-guid d tub column stand
Longitudinal mov m nt tub column
Brake for the longitudinal/horizontal movement of the tube column
Tub h ad up/down
Brake for the height positioning /vertical movement of the tube head
Tub Rotation
Brake for the tube head rotation around the carrying axis
Fr mov m nt (s nsor b n ath th tub h ad)
Permits the horizontal movement of the tube column and vertical movement of the
tube head
Free
movement
Tube head
rotation
Tube head
rotation
L
ongitudinal movement
tube column
U
p & down
movement tube
head

V5.0_2021-11-24
PRS 500 C Instructions for use 5073-0-3002
20 von 3
3.4 Pati nt positioning tabl
CAUTION!
By activating th light barri r, th l ctromagn tic tabl top brak s ar
suppli d with pow r that th y switch off and th tabl top can b mov d. It
must b nsur d that no obj cts ar continuously laying in th light barri r
and p rman ntly trigg r it, oth rwis th brak s ar suppli d with
continuous curr nt and could g t damag d.
3.5 V rtical Bucky Wall Stand
Brake for the vertical movement of the wall stand Bucky.
Up/down
release button
Light barrier to release the table top
brake (represented by the red line)
Power ON/OFF