Protec PRS 500 C Instructions For Use Manual
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Protec PRS 500 C Instructions For Use Manual

Basic diagnostic x-ray system
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PRS 500 C
Basic diagnostic X-ray system
Model/ID: 7073-9-8050
Basis-UDI-DI: 426050264X002ZD
Instructions for use
Ident. No. 5073-0-3002
Version: 5.0
PROTEC GmbH & Co. KG
Issued: 2021-11-24
In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
Subject to alterations
Telephone: +49 (0) 7062/92 55-0 E-Mail: protec@protec-med.com

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  • Page 1 Basic diagnostic X-ray system Model/ID: 7073-9-8050 Basis-UDI-DI: 426050264X002ZD Instructions for use Ident. No. 5073-0-3002 Version: 5.0 PROTEC GmbH & Co. KG Issued: 2021-11-24 In den Dorfwiesen 14, 71720 Oberstenfeld, Germany Subject to alterations Telephone: +49 (0) 7062/92 55-0 E-Mail: protec@protec-med.com...
  • Page 2 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.

  • Page 3: Table Of Contents

    Electromagnetic Environment and Influencing of Devices ..............16 Control Elements and Displays ..................18 Main Switch of the PRS 500 C ..............................18 Emergency Stop Switch of the PRS 500 C ........................18 Emergency Stop Switch Generator ........................18 Floor-guided tube column stand ............................19 Patient positioning table ................................
  • Page 4 Operation RAPIXX system ............................24 Operation CONAXX 2 ..............................24 Function of the PRS 500 C ................................ 24 Switching the PRS 500 C on and off ........................24 Power Box ....................................25 Dosimetric Calibration ..............................25 Exposure automatic ..................................25 Safety and Maintenance ....................
  • Page 5 V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use Vertical X-ray system image receptor stand ........................35 Attenuation Equivalent ................................36 Protection Type and Protection Class ........................36 Automatic cut-off dose ................................36 Analogue system ................................36 Digital system ..................................36 Environmental ....................................

  • Page 6: Document Effectivity

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use 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.

  • Page 7: General Notes

    The X-ray components used by PROTEC are devices only for human medical diagnostic applications and can be adjusted up to a maximum of 150 kV.

  • Page 8: To The User

    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.

  • Page 9: Product Description

    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”.

  • Page 10: Installation

    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.

  • Page 11: Vertical Bucky Wall Stand

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use • Control elements of the control unit are well placed and easy to activate • Reproducible positioning of the X-ray tube assembly when rotating around the tube arm axis by angle indication •...

  • Page 12: Contraindications

    93/42/EEC of 06/14/1993 concerning medical devices, including all applicable corrigenda. The declaration of conformity is available upon request from: PROTEC GmbH & Co. KG In den Dorfwiesen 14 | 71720 Oberstenfeld Germany Telephone: +49 (0) 7062 – 92 55 0 Fax: +49 (0) 7062 –...

  • Page 13: Safety Instructions

    Settings and calibrations that are not described in these instructions for use must be carried out using the technical description of the device by PROTEC service department or a service company authorized by them.
  • Page 14 V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use CD or DVD). This information applies in its entirety as an appendix to these instructions for use and must be observed NOTE All operating elements are marked on the operating console and on the swivel arm or wall stand with clear symbols which are described in detail in the corresponding instructions for use.

  • Page 15: General Safety Instructions

    Device operation In the event of malfunctions, the PRS 500 C X-ray system must no longer be used and PROTEC's customer service department or a service department authorized by PROTEC must be notified.

  • Page 16: Ventilation

    CAUTION! The use of the PRS 500 C immediately next to other devices or with other devices in a stacked form should be avoided, as this could result in defective operation.
  • Page 17 V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use The PRS 500 C is intended for use in an environment in professional health care facilities (e.g., clinics, surgery centres, physiology practices ...). 17 von 39...

  • Page 18: Control Elements And Displays

    Main Switch of the PRS 500 C The PRS 500 C is switched on and off via a mini console (e.g. of the Venus-32/50-R, see Fig. 3.1a), a normal control console (e.g. of the Venus-32/50-R, see Fig. 3.1b) of the X-ray generator or via the switch on the power box (see Fig.

  • Page 19: Floor-Guided Tube Column Stand

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use Floor-guided tube column stand Tube head Tube head rotation rotation Up & down Longitudinal movement movement tube tube column head Free movement Longitudinal movement tube column Brake for the longitudinal/horizontal movement of the tube column...

  • Page 20: Patient Positioning Table

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use Patient positioning table Power ON/OFF Light barrier to release the table top brake (represented by the red line) CAUTION! By activating the light barrier, the electromagnetic table top brakes are supplied with power that they switch off and the table top can be moved. It...

  • Page 21: Control Elements And Device Displays Prognost C

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use Control elements and device displays PROGNOST C Detailed information please find in the enclosed instructions for use of the PROGNOST C. Control elements and device displays Ralco R302 Detailed information please find in the enclosed instructions for use of the Ralco R302.

  • Page 22: Handling

    It must be ensured that the surfaces that come into contact with patients are disinfected before the X- ray examination of each patient (see chapter 5.3). Operation of the PRS 500 C Releasing the table top brake (positioning the table top) By actuating the light barrier with the foot, the brakes of the table top are released, whereby the table top can be moved floating by hand.

  • Page 23: Exposure Preparation / Exposure Releasing

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use 4.2.3.6 Exposure preparation / Exposure releasing • Select the application device (X-ray system table with Bucky, Grid Entity) on the X-ray generator control panel • Set the desired organ program or exposure data and initiate the exposure by pressing the exposure preparation /release controls.

  • Page 24: Operation Neusoft Venus

    Switching the PRS 500 C on and off The PRS 500 C is switched on via the control panel of the generator. All system components are supplied with voltage via the generator. If a power box is included in the system, the power is supplied via the power box.

  • Page 25: Power Box

    PROTEC immediately. Exposure automatic If the PRS 500 C is operated with an exposure automatic the functionality can be checked like as follows: Place a Phantom or any other weakening object (no lead) in the radiation way and position it above the measurement chamber field to be tested.

  • Page 26: Safety And Maintenance

    (see also chapter 4.1). The PRS 500 C must no longer be used with patients if it shows signs of wear (e.g., metal abrasion, wear of insulations) or dangerous technical defects (e.g., torn cable, bent parts) or if the resulting image quality (e.g., artifacts in the image) is insufficient.

  • Page 27: Disinfection

    Technical Description in chapter 3 Maintenance and Safety Inspection. In the event that the planned maintenance is not carried out, PROTEC GmbH & Co. KG assumes no liability for damage to the user or third parties, if damage results from inadequate or not carried out maintenance.

  • Page 28: Warranty

    Warranty work may only be carried out by trained specialists. Product Service Life The PRS 500 C is designed for a service life of 7 years when used in accordance with the specifications and regular maintenance by PROTEC service department or a service company authorized by them.

  • Page 29: Electrical Data

    Input current 2,5 A It is intended that the central power supply of the PRS 500 C is always connected to a supplied X-ray generator or power box using a hard-wired connection. Select a connection that consider the electrical specifications of the PRS 500 C like in the table.

  • Page 30: Guidelines And Manufacturer's Declaration - Electromagnetic Interference

    Guidelines and Manufacturer’s Declaration – Electromagnetic Interference The PRS 500 C is intended for use in the electromagnetic environment specified below. The customer or the operator of the radiographic system should assure that it is used in such an environment.
  • Page 31 V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use EN 61000-4-8 No magnetic should be at levels characteristic of a sensitive parts typical commercial or hospital environment. The quality of the supply voltage Voltage dips, short 0% U for 0,5 period...
  • Page 32 V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use 2450 2400 – 2570 Bluetooth, Pulse modulation: WLAN, 802.11 217 Hz b/g/n, RFID 2450, LTE Band 7 5240 5100 - 5800 WLAN, 802.11 a/n Pulse modulation: 5500 217 Hz 5785 32 von 39...

  • Page 33: Technical Data

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use Technical Data Dimensions Room plan version 1 (operation of the system): PATIENT PATIENT 33 von 39...
  • Page 34 V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use Room plan version 2 (Mounting and removing of the table top): PATIENT PATIENT NOTE The system requires a room size of at least 4250mm, so that it can be fully operated in the room.

  • Page 35: Patient Positioning Table

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use Patient positioning table Table top dimension (L x B): 2280 mm x 800 mm, standard Max. safe working load table 250 kg Table top height: 700 mm ± 100 mm Table top movement, transvers (from the mid-position): Table top movement longitudinal (from the mid-position): ±...

  • Page 36: Attenuation Equivalent

    EN 60601-1-3. Tested at 100 kV with a first half-value layer thickness of 3.7 mm Al. Protection Type and Protection Class The PRS 500 C corresponds to protection class 1 and contains applied parts type B (according to EN 60601-1).

  • Page 37: Description Of Symbols, Labels And Abbreviations

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use Description of symbols, labels and abbreviations Symbols Air pressure limit Temperature limit Humidity limit Keep dry Fragile, handle with care This way up Attention, observe accompanying documents Refer to Instructions for use...

  • Page 38: Generator; Tube; Collimator And Optional Accessories

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use Order reference Disposal instructions; WEEE, Waste of Electrical and Electronic Equipment This symbol indicates the need to consult the instructions for use. This is provided in an electronic format (eIFU) on our website.

  • Page 39: Position Of The Signs And The Labels

    V5.0_2021-11-24 PRS 500 C 5073-0-3002 Instructions for use Position of the signs and the labels Type label Abbreviations Millimetre Centimetre Pound Kilogram °C Degree -Celsius Hectopascal German Industry Standard European Standard CE-Mark Hertz Duty cycle Ampere Serial number 39 von 39...

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