Pro-tec PRS 500 B Manual de usuario

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: 2020-11-12

Subject to alterations

PRS 500 B

Basic diagnostic x-ray syst m

Mod l/ID: 7014-9-0000

Instructions for us

Ident. Nr. 5014-0-0002

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

PRS 500 B

User Manual

5014

0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany

from

Tabl of cont nts

Pag

Tabl of cont nts ........................................................................................................................... 3

Docum nt Eff ctivity .................................................................................................................... 5

G n ral Not s ................................................................................................................................ 6

M chanical – El ctric Warning .................................................................................................... 6

Radiation Warning ........................................................................................................................ 6

To th Us r ..................................................................................................................................... 7

Product d scription ............................................................................................................ 8

1.1 Introduction ......................................................................................................................................................................................... 8

1.2 Description............................................................................................................................................................................................ 8

1.2.1 Equipment components ................................................................................................................................................. 8

1.2.2 Installation ................................................................................................................................................................................

1.2.2.1 Floor capacity ...................................................................................................................................................................

1.3 Product specific characteristics ................................................................................................................................................

1.3.1 Variable height radiographic table ............................................................................................................................

1.3.2 Vertical Bucky Wall Stand ............................................................................................................................................. 10

1.4 Intended use ..................................................................................................................................................................................... 10

1.5 Indication and Contraindication .......................................................................................................................................... 10

1.5.1 Indications ............................................................................................................................................................................. 10

1.5.2 Contra indications ............................................................................................................................................................. 11

1.6 Intended user group .................................................................................................................................................................... 11

1.7 Conformity ......................................................................................................................................................................................... 11

Saf ty Instructions ............................................................................................................ 12

2.1 General safety notice ................................................................................................................................................................... 14

2.1.1 Requirements for operation ....................................................................................................................................... 14

2.1.2 Operating of the radiographic system ................................................................................................................. 14

2.1.2.1 Operating type ............................................................................................................................................................. 14

2.1.3 Operating personnel ....................................................................................................................................................... 14

2.1.4 Pinching and Collision Hazards ................................................................................................................................ 15

2.1.5 Explosion protection ....................................................................................................................................................... 15

2.1.6 Radiation protection ....................................................................................................................................................... 15

2.1.7 Ventilation .............................................................................................................................................................................. 15

2.1.8 Interaction with external devices ............................................................................................................................ 15

2.1. Electromagnetic Environment and the influence of devices ................................................................ 16

Control l m nts and d vic displays ........................................................................... 17

3.1 Control elements and device displays Basic X-ray system table ...................................................................... 17

3.2 Control elements and device displays collimator ..................................................................................................... 17

3.3 Control elements and device displays of X-ray tube ............................................................................................... 17

3.4 Control elements and device displays of X-ray generator ................................................................................... 17

3.5 Control elements of Bucky, Grid entity ............................................................................................................................. 17

3.6 Control elements and device displays of vertical wall stand .............................................................................. 17

3.7 Control elements and device displays of RAPIXX system ..................................................................................... 17

3.8 Control elements and device displays of CONAXX 2 .............................................................................................. 17

Handling / Op ration ........................................................................................................ 18

4.1 Operation with the radiographic system ........................................................................................................................ 18

4.1.1 Operation at the X-ray table ....................................................................................................................................... 18

4.1.1.1 Position of patients on the tabletop ............................................................................................................... 18

4.1.1.2 Setting the X-ray unit to the mid of movable Bucky, Grid entity .................................................. 18

4.1.1.3 Inserting a cassette into the cassette tray .................................................................................................... 18

4.1.1.4 Adjusting the source to image-detector distance (SID) ..................................................................... 18

4.1.1.5 Adjusting the light resp. X-ray field .................................................................................................................. 18

4.1.1.6 Exposure preparation / exposure release .................................................................................................... 1

4.1.1.7 On table exposures .................................................................................................................................................... 1

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User Manual

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4.1.1.8 Exposures with the lateral detector holder (optional) ......................................................................... 1

4.1.2 Operation at vertical wall stand................................................................................................................................ 21

4.1.2.1 Anti-collision sensor .................................................................................................................................................. 21

4.1.2.2 Adjustment of the X-ray unit to the mid of a cassette or Bucky/Grid entity of a X-ray

table (horizontal center beam) .................................................................................................................................................. 22

4.1.2.3 Adjustment of the source to image-receptor distance (SID) ........................................................... 22

4.1.2.4 Adjustment of the light-/ radiation field....................................................................................................... 22

4.1.2.5 Exposure preparation/ release ............................................................................................................................ 22

4.1.3 Operation collimator ....................................................................................................................................................... 22

4.1.4 Operation X-ray Tube ..................................................................................................................................................... 23

4.2 Operation X-ray generator ....................................................................................................................................................... 23

4.3 Operation Bucky, Grid entity ................................................................................................................................................... 23

4.4 Operation RAPIXX system......................................................................................................................................................... 23

4.5 Operation Software ...................................................................................................................................................................... 23

4.6 Function of the PRS 500 B ........................................................................................................................................................ 24

4.6.1 Switching the PRS 500 B ON ...................................................................................................................................... 24

4.6.2 Switching the PRS 500 B OFF ..................................................................................................................................... 24

4.6.3 Dosimetric Calibration (only PROVARIO HF) ..................................................................................................... 25

4.7 Exposure automatic ..................................................................................................................................................................... 25

Saf ty and Maint nanc ................................................................................................... 26

5.1 Introduction ...................................................................................................................................................................................... 26

5.2 Cleaning and disinfection ......................................................................................................................................................... 26

5.2.1 Cleaning .................................................................................................................................................................................. 26

5.2.2 Disinfection ........................................................................................................................................................................... 26

5.3 Check-up and maintenance ................................................................................................................................................... 27

5.3.1 Daily Controls (prior to or during the unit operation) ................................................................................ 27

5.3.2 Regular controls ................................................................................................................................................................. 27

5.3.3 Maintenance ........................................................................................................................................................................ 27

5.3.4 Warranty .................................................................................................................................................................................. 27

5.3.5 Product life time ................................................................................................................................................................. 27

5.3.6 Further Information ......................................................................................................................................................... 27

5.3.7 Applied Parts and parts which get handled like an application part ................................................ 28

5.3.8 Disposal ................................................................................................................................................................................... 28

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

6.1 Electromagnetic Compatibility (EMC) after EN 60601-1-2 ................................................................................... 30

6.1.1 Guidelines and Manufacturers declaration – electromagnetic interference (non-life

supporting device) ................................................................................................................................................................................... 30

T chnical Data .................................................................................................................... 34

7.1 Dimensions ........................................................................................................................................................................................ 34

7.2 X-ray table .......................................................................................................................................................................................... 35

7.3 Bucky, Grid entity ........................................................................................................................................................................... 35

7.4 X-ray column .................................................................................................................................................................................... 35

7.5 Wall column stand ........................................................................................................................................................................ 35

7.6 Attenuation Equivalent .............................................................................................................................................................. 36

7.6.1 Protection Art and Protection Class ....................................................................................................................... 36

7.7 Automatic cutoff dose ................................................................................................................................................................ 36

7.7.1 Analogue System .............................................................................................................................................................. 36

7.7.2 Digital System ...................................................................................................................................................................... 36

7.8 Environmental ................................................................................................................................................................................. 36

7.8.1 Environmental conditions during operation ................................................................................................... 36

7.8.2 Environmental Conditions for Shipping and Storage ................................................................................ 36

D scription of symbols, lab ls and abbr viations ....................................................... 37

8.1 Symbols ............................................................................................................................................................................................... 37

8.2 Identification label......................................................................................................................................................................... 3

8.3 Labels .................................................................................................................................................................................................... 3

8.4 Position symbols and labels .................................................................................................................................................... 41

8.5 Abbreviations ................................................................................................................................................................................... 42

PRS 500 B

User Manual

5014

0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany

from

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

1.0 14/02/2018 all Original issue

2.0 08/06/2018 6, , 10, 1 , 20

Radiation warning,

Detector size customized,

switching on/off the

system, displayed SID

3.0 10/10/2018 New component, Venus

50R 1phase

4.0 30/01/2020 20-22, 25

Anti-collision sensor,

lateral detector holder,

switching on and off PRS

500 B

5.0 2020-11-12 Chap. 6 New Generators

PRS 500 B

User Manual

5014

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PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany

from

G n ral Not s

WARNING!

No chang s of th ME d vic !

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 housing 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

WARING!

Th compon nt of th quipm nt 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 g n rat a pot ntial risk for both pati nts and op rators.

For this r ason, th application of X-rays for a giv n m dical purpos must

aim at th minimization of radiation xposition to any p rsons. Thos p rsons

r sponsibl for th application must hav th sp cific knowl dg according

to l gal r quir m nts and r gulations and must stablish saf xposur

proc dur s for th s kinds of syst ms. Thos p rsons, r sponsibl for th

planning and installation of this quipm nt, must obs rv th national

r gulations.

Th syst m caus s diff r nt ionising radiation. Th purpos is to cr at

charact ristic X-ray radiation. Th int nsity d p nds on th adjust d valu s of

voltag , curr nt and tim . Th radiation com s orthogonal out of th X-ray

tub and is limit d by th collimator.

PRS 500 B

User Manual

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PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany

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To th Us r

NOTE

The user of this Document is directed to read and carefully review the instructions,

warnings and cautions contained herein prior to beginning operation, installation or

service activities.

While you may have previously operated equipment similar to that described in this

Document, changes in design, manufacture or procedure may have occurred which

significantly affect the present operation.

Although the product was subject to a risk analysis and the design corresponds to

the current state of the art, residual risk will remain in clinical use. These are

displayed in the following user manual by application limitations, contraindications,

warnings and precautions.

The installation and service of equipment described herein is to be performed by

authorized, qualified PROTEC GmbH & Co. KG Customers.

Assemblers and other Customers not employed by nor directly affiliated with

PROTEC GmbH & Co. KG technical services are directed to contact the local

PROTEC GmbH & Co. KG office before attempting installation or service

procedures.

For Installations and service procedures it is necessary to read the „technical

description“ of the product and to observe any containing point in it.

NOTE

The usage of the product in combination with accessories which aren’t authorized

by PROTEC is forbidden.

PRS 500 B

User Manual

5014

0002

PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany

from

Product d scription

1.1 Introduction

This user manual describes the special features and operational aspects of the PRS 500 B, knowledge of

which are required for efficient and effective use of the radiographic system.

Prior to working with the PRS 500 B, it is required that the user read the Safety Notes as well as the

chapter regarding operation.

1.2 D scription

The PRS 500 B radiography system is a motorized X-ray system with an autotracking function for

versatile applications and a high workload. Due to the integrated sophisticated autotracking functions

the system enables the user a comfortable, fast and efficient daily workflow. This complete system

delivers excellent exposure quality supporting any kind of X-ray examinations in radiological centers,

clinics and hospitals, regardless whether it is used for analog or digital imaging techniques.

1.2.1 Equipm nt compon nts

The PRS 500 B can be equipped or customized with the following components:

•Horizontal, height adjustable patient positioning table with floating tabletop and integrated

column stand with control arm,

•Bucky with cassette tray or detector- grid unit*,

•3-field measuring chamber*,

•Vertical Bucky Wall stand*,

•X-Ray Generator,

•X-Ray tube assembly with housing*,

•Anti-scatter Grid*

•Collimator*

Optional compon nts

•Dose area product meter system* and

•Different direct X-Ray-systems

(consisting of DR-detector* (such as RAPIXX-Series), Interface Box, and Software)

•Software CONAXX 2

Optional Acc ssori s

The PRS 500 B can be equipped or customized with the following accessories:

•Ceiling bracket cabeling 4m (ID: 0014-0-0100)

•Wall bracket cabeling 4m (ID: 0014-0-0110)

•Dose area product meter system (ID: 7753-0-2363)

•DAP chamber cable 15m (ID: 7753-0-2566)

•Wall bracket (ID: 7021-0-0515)

•Patient extending handle (ID: 7014-0-4001)*

•Hand grip tabletop (ID: 7014-0-4002)

•Detectorhold incl. 2 hand grip (ID: 7014-0-4003)

* These components can also be used in a patient area.

Acc ssori s which may aff ct EMC

•Network cable (consider max. length of cable noted in the documentation of components)

•Data cable for RAPIXX connection (consider max. length of cable noted in the documentation of

components)

•WLAN-Router (Use only devices approved by PROTEC)

•…

PRS 500 B

User Manual

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PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany

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1.2.2 Installation

See separate “Installation manual” PRS 500 B.

Contact information of persons which are qualified to make installations are requestable 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: protec@protec-med.com

Internet: www.protec-med.com

1.2.2.1 Floor capacity

NOTE

he X

ray system is primarily made

of metal pieces. This has a main role in the

weight of the device.

The X-ray system PRS 500 B has a weight of 00kg (incl. UT Generator).

Every technician is obliged to check the ground load. Also double bottoms and

hollow floors have to be taken into account.

1.3 Product sp cific charact ristics

1.3.1 Variabl h ight radiographic tabl

•Variable table height (57,5 cm – 87,5cm)

•Floating tabletop

•Tabletop colour – white

•Magnetic activated tabletop brake for effortless patient positioning

•A low (optimized) distance between the tabletop surface and the film (detector) surface

•Large adjustment range of the tabletop for position of the patient

•Reliable construction

•Lateral rails of the tabletop prepared to accept a number of table accessories

•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 analog or digital use

•Column stand intended for use within rooms with a ceiling height of at least 2.5 meters

•Control elements within the control panel well placed and easy to activate

•Reproducible positioning of the X-Ray tube assembly (positions resulting from rotation around

the axis of the carrying arm) through angle indicator

•Vertical range of travel of the focus height from 35 cm up to 180 cm during horizontal beam

projection

•Electromagnetic brakes for the longitudinal movement of the tube 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 with integrated latching every 0°as well as the vertical movements

of the thorax Bucky.

•Integrated safety connector for automatically centering the X-Ray tube assembly and the Bucky

in the longitudinal direction (under-table position) or in the vertical direction (thorax position).

•Prepared for digital Bucky’s

PRS 500 B

User Manual

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PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany

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1.3.2 V rtical Bucky Wall Stand

•Space saving with minimal footprint

•Floor mounted wall stand

•cassette loading from the right or left side (specified at installation)

•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 analog or digital use

•Prepared for digital Bucky’s

1.4 Int nd d us

The general-purpose 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.

NOTE

At the acceptance test a 25mm Aluminium / ,5% purity can be used as a

phantom for a patient equivalent.

The acceptance test has to be made in accordance to the local laws and directives.

Only Special trained People are allowed to do this.

1.5 Indication and Contraindication

1.5.1 Indications

Justification of m dical xposur s

According to §23 of the German Radiological Ordinance (RöV), 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.

A complete list of indications is unrealisable for conventional radiography, because the spectrum of

conventional X-rays is very diverse and can vary in the course of medical-technical progress.

Some examples of indications for an X-ray examination may be:

•For the diagnosis of a bone fracture or bony injuries of the skeletal system or pathological

changes of hard tissues.

•To control the bone setting.

•For the diagnosis of luxations and ligament ruptures of the locomotor system.

•For the diagnosis of degenerative, inflammatory, traumatic and tumorous diseases and

changes of the locomotor 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).

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