Pro-tec PRS 500 X 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 X

Basic diagnostic X-ray syst m

Mod l/ID: 7066-9-8050

Instructions for us

Ident. Nr. 5066-0-8002

PRS 500 X

in analogue base configuration

NOTE

All sheets of this document contain proprietary and confidential information of

PROTEC GmbH & Co. KG and is intended for exclusive use by current PROTEC GmbH

& Co. KG customers. Copying, disclosure to 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

Deutschland

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 X

Instructions for use

5066

002

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

von

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 X-ray system tube support, floor stand ..................................................................................................................

1.3.2 X-ray system image receptor stand ..........................................................................................................................

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

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

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

1.5.2 Contra indications ............................................................................................................................................................. 10

1.6 Intended user group .................................................................................................................................................................... 10

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

2.1.3 Operating type .................................................................................................................................................................... 14

2.1.4 Operating personnel ....................................................................................................................................................... 14

2.1.5 Pinching and Collision Hazards ................................................................................................................................ 15

2.1.6 Explosion protection ....................................................................................................................................................... 15

2.1.7 Radiation protection ....................................................................................................................................................... 15

2.1.8 Ventilation .............................................................................................................................................................................. 15

2.1. Interaction with external devices ............................................................................................................................ 15

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

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

3.1 Control elements and device displays PROGNOST SH ........................................................................................... 17

3.1.1 Operating unit PROGNOST SH, Standard .............................. F hl r! T xtmark nicht d fini rt.

3.1.2 Operating unit PROGNOST SH, TOUCH .................................. F hl r! T xtmark nicht d fini rt.

3.2 Control elements and device displays collimator ..................................................................................................... 20

3.3 Control elements and device displays of X-ray tube ............................................................................................... 20

3.4 Control elements and device displays of X-ray generator ................................................................................... 20

3.5 Control elements of Bucky, Grid entity ............................................................................................................................. 20

3.6 Control elements and device displays of X-ray system image receptor stand PROVERT ................. 21

3.6.1 Vertical carriage .................................................................................................................................................................. 21

3.7 Control elements and device displays of RAPIXX system ..................................................................................... 21

3.8 Control elements and device displays of CONAXX 2 .............................................................................................. 21

Handling / Op ration ........................................................................................................ 22

4.1 Operation with the radiographic system ........................................................................................................................ 22

4.1.1 Operation at the X-ray system table ...................................................................................................................... 22

4.1.1.1 Position of patients on the tabletop* ............................................................................................................. 22

4.1.1.2 Setting the X-ray unit on the mid moving Bucky, Grid entity ......................................................... 22

4.1.1.3 Inserting a cassette into the cassette tray .................................................................................................... 22

4.1.1.4 Adjusting the focus-film distance (FFD) ........................................................................................................ 22

PRS 500 X

Instructions for use

5066

002

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

von

4.1.1.5 Adjusting the light resp. X-ray field .................................................................................................................. 22

4.1.1.6 Exposure preparation / exposure release .................................................................................................... 22

4.1.1.7 Overtable exposures ................................................................................................................................................. 22

4.1.2 Operation at X-ray system image receptor stand PROVERT ................................................................... 24

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

system image receptor stand (vertical center beam) ................................................................................................. 24

4.1.2.2 Adjustment of the source to image-receptor distance (SID) ........................................................... 24

4.1.2.3 Adjustment of the light-/ radiation field....................................................................................................... 24

4.1.2.4 Exposure preparation/ release ............................................................................................................................ 24

4.2 Operation collimator ................................................................................................................................................................... 24

4.3 Operation X-ray tube ................................................................................................................................................................... 24

4.4 Operation X-ray generator ....................................................................................................................................................... 25

4.5 Operation Bucky, Grid entity ................................................................................................................................................... 25

4.6 Operation X-ray system image receptor stand PROVERT ..................................................................................... 25

4.7 Operation RAPIXX system......................................................................................................................................................... 25

4.8 Operation Software ...................................................................................................................................................................... 25

4. Function of the PRS 500 X ........................................................................................................................................................ 25

4. .1 Switching On/Off the PRS 500 X .............................................................................................................................. 25

4. .2 Dosimetric Calibration (only for PROVARIO HF) ............................................................................................. 25

4.10 Exposure automatic ..................................................................................................................................................................... 26

Saf ty and Maint nanc ................................................................................................... 27

5.1 Introduction ...................................................................................................................................................................................... 27

5.2 Cleaning and disinfection ......................................................................................................................................................... 27

5.2.1 Cleaning .................................................................................................................................................................................. 27

5.2.2 Disinfection ........................................................................................................................................................................... 27

5.3 Check-up and maintenance ................................................................................................................................................... 28

5.3.1 Daily Controls (prior to or during the unit operation) ................................................................................ 28

5.3.2 Regular controls ................................................................................................................................................................. 28

5.3.3 Only original spare parts are to be used in situations requiring component replacement

Maintenance ................................................................................................................................................................................................ 28

5.3.4 Warranty .................................................................................................................................................................................. 28

5.3.5 Product life time ................................................................................................................................................................. 28

5.3.6 Further Information ......................................................................................................................................................... 28

5.3.7 Applied Parts and parts which get handled like an application part ................................................ 2

5.3.8 Disposal ................................................................................................................................................................................... 2

El ctrical data ..................................................................................................................... 30

6.1 Electromagnetic Compatibility (EMC) after EN 60601-1-2 ................................................................................... 31

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

supporting device) ................................................................................................................................................................................... 31

T chnical Data .................................................................................................................... 32

7.1 Dimensions ........................................................................................................................................................................................ 32

7.2 X-ray system tube support, floor stand ............................................................................................................................ 34

7.3 X-ray system image receptor stand .................................................................................................................................... 34

7.4 Attenuation Equivalent .............................................................................................................................................................. 34

7.4.1 Protection Art and Protection Class ....................................................................................................................... 34

7.5 Automatic cutoff dose ................................................................................................................................................................ 34

7.5.1 Analogue System .............................................................................................................................................................. 34

7.5.2 Digital System ...................................................................................................................................................................... 34

7.6 Environmental ................................................................................................................................................................................. 35

7.6.1 Environmental conditions during operation ................................................................................................... 35

7.6.2 Environmental Conditions for Shipping and Storage ................................................................................ 35

D scription of symbols, lab ls and abbr viations ....................................................... 36

8.1 Symbols ............................................................................................................................................................................................... 36

8.2 Identification label......................................................................................................................................................................... 37

8.3 Labels .................................................................................................................................................................................................... 38

8.4 Position symbols and labels .................................................................................................................................................... 3

8.5 Abbreviations ................................................................................................................................................................................... 40

PRS 500 X

Instructions for use

5066

002

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

von

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

1.0 201 -05-14 all

New created, replaces

document 5061-0-

0002_V4

2.0 201 -07-31 Cap. 1.2, 6.1.1, 7.1, 8.1, 8.2,

8.4

GMDN terms updated

Changed optional

accessories and images

dimension

EMC tables removed

Symbols added

Identification label

updated

3.0 2020-06-1 Cap. 1.2.2.1, 1.3.1, 3.1, 7.2 Telescopic arm added

4.0 2020-08-11 Front page, Cap. 5.3.3 Maintenance updated

5.0 2020-11-12 Cap. 1.2.1; Cap.6; Cap. 3.1.1;

Cap. 3.1.2; Cap. 4.1.1.8

New generators,

Rotatable X-ray column

added

PRS 500 X

Instructions for use

5066

002

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

von

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 X

Instructions for use

5066

002

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

von

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 X

Instructions for use

5066

002

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

von

Product d scription

1.1 Introduction

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

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

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

chapter regarding operation.

1.2 D scription

1.2.1 Equipm nt compon nts

The PRS 500 X consists of the following components:

•Floor railed X-ray system tube support with control arm,

•Bucky or Grid entity,

•X-ray system image receptor stand,

•X-ray Generator, PROVARIO HF-, VENUS-, CMP- or RFX series

•X-ray tube assembly with housing,

•Collimator

Optional compon nts

•Anti-scatter Grid

•3-field measuring chamber,

•Dose area product meter system and

•Different direct X-ray-systems (RAPIXX-Serial)

(consisting of DR-detector, Interface Box, and Software)

•Software CONAXX 2

Optional Acc ssori s

The PRS 500 X can be equipment or customized with the following accessories:

•Patient extending handle

•Compression band

•Strain relief cable hose X-ray system image receptor stand

•Mobile patient X-ray system table for digital or conventional exposures from the PROTEC

PROGNOST series

−PROGNOST XS

−PROGNOST XP

−PROGNOST XPE

−PROGNOST XPE-Akku

−Lateral Detector holder

Only with rotatable X-Ray column PROGNOST SH and X-ray system table PROGNOST.

Acc ssori s which can influ nc th EMC-Condition

•Network cable (note the max. length in the documents)

•RAPIXX Data-Cable (note the max. length in the documents)

•WLAN-Router (only use devices that has an authorization by PROTEC)

•…

PRS 500 X

Instructions for use

5066

002

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

von

1.2.2 Installation

See separate “Installation manual” PRS 500 X.

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

radiographic

system is primarily made of metal pieces. This has a main role in

the weight of the device.

The radiographic system PRS 500 X has a w ight of 642kg (incl. Generator),

option: telescopic arm 30kg (additionally).

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 X-ray syst m tub support, floor stand

•Ceiling-free column stand intended for use within rooms with a ceiling height of at least 2.3

meters

•Wide range of application

•Small wall distance allows good space utilization

•Control elements within the command arm 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 2 .4 cm up to 188.2 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 +/-180° with integrated latching every 0° as well as transversal

movement of the carrying arm +230mm (optional).

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

in the longitudinal direction

1.3.2 X-ray syst m imag r c ptor stand

•Space saving with minimal footprint

•Wall – floor mounting of floor mounting

•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

1.4 Int nd d us

The general-purpose diagnostic radiographic 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.

PRS 500 X

Instructions for use

5066

002

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

von

NOTE

At the accept

ance 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 §83 of the German radiation protection law (StrlSchG), an X-ray examination is only

justified if the patients benefit from x-ray diagnostics outweighs the radiation risk. The examination

method, means the conventional X-ray with the PRS 500 system, must be suitable to answer the

diagnostic question and no other more suitable alternative method is available.

Accordingly, it is also described by the International Atomic Energy Agency (IAEA) in the document

Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards (Requirement 37:

Justification of medical exposures). It also refers to the need to consider national or international

guidelines for the justification of a medical exposure.

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).

1.5.2 Contra indications

There are no absolute contraindications for conventional X-rays.

But it is not allowed to make any exposures on humans when they are not medically indicated (see

Justification of medical exposures, chapter 1.5.1 Indication).

For pregnant women and children it is important to consider if the exposure is really necessary. It

should be avoided if possible.

1.6 Int nd d us r group

The radiographic system PRS 500 X is exclusively designated for use by professional who are trained, in

accordance with the corresponding national regulations, in the use of diagnostic X-Ry equipment and

its proper intended use in connection with other medical devices, objects and accessories.

Suitable users could include the following: Radiologist, radiology assistants, radiology technicians,

doctors and other medically trained personnel.

Otros manuales para PRS 500 X

Este manual sirve para los siguientes modelos

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Pro-tec PRS 500 F Manual de usuario

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Pro-tec PROGNOST XS Manual de usuario

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Pro-tec PRS 500 F Manual de usuario

Pro-tec

Pro-tec PRS 500 E Manual de usuario

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Pro-tec PRS 500 B Manual de usuario

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Pro-tec PRS 500 F Manual de usuario

Pro-tec

Pro-tec PRS 500 B Manual de usuario

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Pro-tec PRS 500 E Hoja de instrucciones

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Pro-tec 6000CCO Manual de instalación y operación

Pro-tec

Pro-tec PRS 500 E Manual de usuario

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