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: 4.0

Issued: 2021-03-11

Subject to alterations

PRS 500 C

Basic diagnostic X-ray syst m

Mod l/ID: 7073-9-8050

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

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 C

Instructions for use

5073

3002

von

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............................................................................................................................................................................................

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

1.2.2 Installation ............................................................................................................................................................................. 10

1.2.2.1 Floor capacity ................................................................................................................................................................ 10

1.3 Product specific characteristics ............................................................................................................................................. 10

1.3.1 Radiographic table ........................................................................................................................................................... 10

1.3.2 Floor railed X-ray system tube support ............................................................................................................... 10

1.3.3 Vertical Bucky Wall Stand ............................................................................................................................................. 11

1.4 Intended use ..................................................................................................................................................................................... 11

1.5 Indication and Contraindication .......................................................................................................................................... 11

1.5.1 Indications ............................................................................................................................................................................. 11

1.5.2 Contra indications ............................................................................................................................................................. 12

1.6 Intended user group .................................................................................................................................................................... 12

1.7 Conformity ......................................................................................................................................................................................... 12

Saf ty Instructions ............................................................................................................ 13

2.1 General safety notice ................................................................................................................................................................... 15

2.1.1 Requirements for operation ....................................................................................................................................... 15

2.1.2 Operating of the radiographic system ................................................................................................................. 15

2.1.3 Operating personnel ....................................................................................................................................................... 15

2.1.4 Pinching and Collision Hazards ................................................................................................................................ 16

2.1.5 Explosion protection ....................................................................................................................................................... 16

2.1.6 Radiation protection ....................................................................................................................................................... 16

2.1.7 Ventilation .............................................................................................................................................................................. 16

2.1.8 Interaction with external devices ............................................................................................................................ 16

2.1. Electromagnetic Environment and the influence of devices ................................................................ 17

Control l m nts and d vic displays ........................................................................... 18

3.1 Control elements and device display of Basic X-ray system ............................................................................... 18

3.1.1 Floor railed X-ray system tube support ............................................................................................................... 18

3.1.2 Radiographic table ........................................................................................................................................................... 1

3.1.3 Vertical Bucky Wall Stand ............................................................................................................................................. 1

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 RAPIXX system ..................................................................................... 20

3.7 Control elements and device displays of CONAXX 2 .............................................................................................. 20

Handling / Op ration ........................................................................................................ 21

4.1 Operation with the radiographic system ........................................................................................................................ 21

4.1.1 Operation at the X-ray table ....................................................................................................................................... 21

4.1.1.1 Position of patients on the table top .............................................................................................................. 21

4.1.1.2 Setting the X-ray unit on the mid moving Bucky, Grid entity ......................................................... 21

4.1.1.3 Inserting a cassette into the cassette tray .................................................................................................... 21

4.1.1.4 Adjusting the focus-film distance (SID) ......................................................................................................... 21

4.1.1.5 Adjusting the light resp. X-ray field .................................................................................................................. 21

PRS 500 C

Instructions for use

5073

3002

von

4.1.1.6 Exposure preparation / exposure release .................................................................................................... 21

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

4.1.2 Operation at vertical wall stand................................................................................................................................ 22

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

system image receptor stand (vertical center beam) ................................................................................................. 22

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

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

4.1.2.4 Exposure preparation/ release ............................................................................................................................ 22

4.2 Operation collimator ................................................................................................................................................................... 22

4.3 Operation X-ray Tube .................................................................................................................................................................. 23

4.4 Operation X-ray generator ....................................................................................................................................................... 23

4.5 Operation Bucky, Grid entity ................................................................................................................................................... 23

4.6 Operation RAPIXX system......................................................................................................................................................... 23

4.7 Operation Software ...................................................................................................................................................................... 23

4.8 Switching On/Off the PRS 500 C .......................................................................................................................................... 23

4.8.1 Power Box .............................................................................................................................................................................. 24

4.8.2 Dosimetric Calibration VENUS, CMP, RFX generators ................................................................................. 24

4. Exposure automatic ..................................................................................................................................................................... 24

Saf ty and Maint nanc ................................................................................................... 25

5.1 Introduction ...................................................................................................................................................................................... 25

5.2 Cleaning and disinfection ......................................................................................................................................................... 25

5.2.1 Cleaning .................................................................................................................................................................................. 25

5.2.2 Disinfection ........................................................................................................................................................................... 25

5.3 Check-up and maintenance ................................................................................................................................................... 26

5.3.1 Daily controls (prior to or during the unit operation) by the user ...................................................... 26

5.3.2 Regular controls by the user....................................................................................................................................... 26

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

Maintenance ................................................................................................................................................................................................ 26

5.3.4 Warranty .................................................................................................................................................................................. 26

5.3.5 Product life time ................................................................................................................................................................. 26

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

5.3.7 Applied Parts and parts which get handled like an application part ................................................ 27

5.3.8 Disposal ................................................................................................................................................................................... 27

El ctrical data ..................................................................................................................... 28

6.1 Connection ........................................................................................................................................................................................ 28

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

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

supporting device) ................................................................................................................................................................................... 2

T chnical Data .................................................................................................................... 30

7.1 Dimensions ........................................................................................................................................................................................ 30

7.2 X-ray system table ......................................................................................................................................................................... 31

7.2.1 X-ray mattress ...................................................................................................................................................................... 31

7.3 Bucky unit ........................................................................................................................................................................................... 31

7.4 X-ray stem tube support, floor stand ................................................................................................................................. 31

7.5 Vertical X-ray system image receptor stand .................................................................................................................. 31

7.6 Attenuation Equivalent .............................................................................................................................................................. 32

7.6.1 Protection Art and Protection Class ....................................................................................................................... 32

7.7 Automatic cutoff dose ................................................................................................................................................................ 32

7.7.1 Analogue System .............................................................................................................................................................. 32

7.7.2 Digital System ...................................................................................................................................................................... 32

7.8 Environmental ................................................................................................................................................................................. 32

7.8.1 Environmental conditions during operation ................................................................................................... 32

7.8.2 Environmental Conditions for Shipping and Storage ................................................................................ 32

D scription of symbols, lab ls and abbr viations ....................................................... 33

8.1 Symbols ............................................................................................................................................................................................... 33

8.1.1 Generator; Tube; collimator and optional accessories ............................................................................... 33

8.2 Identification label......................................................................................................................................................................... 34

PRS 500 C

Instructions for use

5073

3002

von

8.3 Labels .................................................................................................................................................................................................... 34

8.4 Position symbols and labels .................................................................................................................................................... 35

8.5 Abbreviations ................................................................................................................................................................................... 35