Pro-tec PRS 500 C User manual

PROTEC GmbH & Co. KG

In den Dorfwiesen 14, 71720 Oberstenfeld, Germany

Telephone: +4 (0) 7062/ 2 55-0 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.

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

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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

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

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

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

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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

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

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

El ctrical data ..................................................................................................................... 29

6.1 Electromagnetic Compatibility (EMC) according to EN 60601-1-2 ................................................................ 2

Guidelines and Manufacturer’s Declaration – Electromagnetic Interference .............................. 30

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

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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

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

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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,

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 ,

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

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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.

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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.

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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".

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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: protec@protec-med.com

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

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