Protec PRS 500 X 7066-9-8050 V Series Instructions For Use Manual

Protec PRS 500 X 7066-9-8050 V Series Instructions For Use Manual

Basic diagnostic x-ray system
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PRS 500 X
Basic diagnostic X-ray system
Model/ID: 7066-9-8050_Vxxx
Basic UDI-DI: 426050264X007ZP
Instructions for use
Ident. Nr. 5066-0-8002
PRS 500 X in analogue base configuration
Version: 6.5
PROTEC GmbH & Co. KG
Issued: 2024-04-12
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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Summary of Contents for Protec PRS 500 X 7066-9-8050 V Series

  • Page 1 Basic UDI-DI: 426050264X007ZP Instructions for use Ident. Nr. 5066-0-8002 PRS 500 X in analogue base configuration Version: 6.5 PROTEC GmbH & Co. KG Issued: 2024-04-12 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 others or other use is prohibited without the express written consent of PROTEC´s law department.
  • Page 3: Table Of Contents

    Control elements of Bucky, Grid entity ..........................24 Control elements and Display of X-ray system image receptor stand PROVERT ........25 3.8.1 Vertical carriage .................................. 25 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 3 von 47...
  • Page 4 X-ray Tube Support Stand ................................ 41 Image Receptor Stand ................................42 Attenuation Equivalent ................................42 7.4.1 Protection Type and Protection Class ........................42 Automatic Cut off Dose ................................42 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 4 von 47...
  • Page 5 Description of Symbols, Labels and Abbreviations ............. 44 Symbols ....................................... 44 Identification label..................................45 Labels ........................................46 Position symbols and labels ..............................46 Abbreviations ....................................47 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 5 von 47...
  • Page 6: Revision Status

    Chap. 1.3.1, 3.3.1, 3.3.2, 8.1 of X-ray tube stand added Traveling distance long floor 2023-07-12 List 7.2; Chap.8.2; page 13 rails new; Typelable; FB-04- 07A4.3 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 6 von 47...
  • Page 7 4.10.2 the column rotation, traveling distance for 2024-04-12 angulation around horizontal tube column added, dosimetric calibration removed. Chap. 4.2.1.1 Releasing tabletop brake added PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 7 von 47...
  • Page 8: General Notes

    The X-ray components from PROTEC used are only devices for the human medical diagnostic area, which can be set up to a maximum of 150 kV. Further information can be found in the technical data inside the instructions for use for the generators, X-ray tubes and collimators.
  • Page 9: 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 10: Device Description

    – regardless of whether analogue or digital imaging methods are used. 1.2.1 System Components The PROTEC X-ray system PRS 500 X consists of the following components: • Floor railed X-ray system tube support with control arm •...
  • Page 11: Hardware And Network System Requirements

    Installation NOTE The installation of the PRS 500 X must be carried out by PROTEC customer service or a service provider authorized by them. This X-ray system PRS 500 X must be installed in a shielded X-ray room that complies with national radiation protection regulations.
  • Page 12: Image Receptor Stand

    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). PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 12 von 47...
  • Page 13: Indications And Contraindications

    In den Dorfwiesen 14 | 71720 Oberstenfeld Telephone: +49 (0) 7062 – 92 55 0 Fax: +49 (0) 7062 – 92 55 60 E-Mail: protec@protec-med.com Internet: www.protec-med.com PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 13 von 47...
  • Page 14: 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 15 In the case of pregnant women and children, it must be carefully considered whether an exposure is necessary. It should be avoided if possible. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 15 von 47...
  • Page 16: General Safety Instructions

    Power Box must be switched off. 2.1.2 Device Operation In case of a malfunction, do not use the PRS 500 X anymore and notify PROTEC service department or a service company authorized by them. 2.1.2.1 Operating Type The PRS 500 X is not intended for continuous operation.
  • Page 17: Crushing And Collision Hazards

    It is important to ensure that the air exchange of the X-ray generator within the system is not hindered. The ambient air temperature is not allowed to exceed 40°C. 2.1.8 Interaction with Other Devices Interactions with other devices are not known. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 17 von 47...
  • Page 18: Electromagnetic Environment And The Influence Of Devices

    The PRS 500 X is intended for use in an environment in professional health care facilities (e.g. clinics, surgery centres, physiology practices ...). PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 18 von 47...
  • Page 19: Control Elements And Displays

    Ready for exposure Radiation indicator Fig. 3.1b Control console Venus-32/50-R Switching off the PRS 500 X Switching on the PRS 500 X Fig. 3.1c Power Box Switch PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 19 von 47...
  • Page 20: Emergency Stop Switches Of The X-Ray System

    In this state no x-rays may be taken. The X-ray tube carrier must first engage in one of the positions (0 / ± 90° / ± 180°)! PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 20 von 47...
  • Page 21: Prognost Sh Touch

    In this state no x-rays may be taken. The X-ray tube carrier must first engage in one of the positions (0 / ± 90° / ± 180°)! PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 21 von 47...
  • Page 22: Foot Pedal

    To rotate the X-ray column, the Buckywagen must be pushed out of the driver bracket of the X-ray column. WARNING! There is an increased risk of injury if the X-ray tube carrier is not engaged! PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 22 von 47...
  • Page 23 V6.5_2024-04-12 PRS 500 X 5066-0-8002 Instructions for use Detailed information please find in the accompanying Instructions for use PROGNOST SH. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 23 von 47...
  • Page 24: Control Elements And Display Of Collimator

    Detailed information please find in the enclosed Instructions for use of the X-ray generator. Control elements of Bucky, Grid entity Detailed information please find in the enclosed Instructions for use. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 24 von 47...
  • Page 25: Control Elements And Display Of X-Ray System Image Receptor Stand Provert

    Detailed information please find in the enclosed Instructions for use of the RAPIXX system. 3.10 Control elements and device displays of CONAXX 2 Detailed information please find in the enclosed Instructions for use of the CONAXX 2. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 25 von 47...
  • Page 26: Handling / Operation

    X-ray tube unit. For correct central positioning, the arrow shown must point to the bracket. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 26 von 47...
  • Page 27: Inserting An Image Receptor Into The Cassette Tray

    On-table exposures • Place an image receptor to the desired position on the tabletop. • Move X-ray tube to the desired position and adjust FFD. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 27 von 47...
  • Page 28: Exposures With The Lateral Detector Holder (Optional)

    Push the tube column to the lateral detector holder − Adjust the height of the tube arm or of the table that the light field is aligned to the panel PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 28 von 47...
  • Page 29: Operation At X-Ray System Image Receptor Stand Provert

    The settings will be done on the scale 2 and 8 (figure collimator) to the according source-image distance (SID). So the light-/ radiation field is limited to the according image receptor. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 29 von 47...
  • Page 30: Exposure Preparation/ Release

    A system restart is only possible after the touch display has been shut down completely. Otherwise the touch display will not start. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 30 von 47...
  • Page 31: 4.11 Automatic Exposure Control

    If this works properly, the measured value is displayed. Repeat this procedure for all existing measuring chamber fields. If an error message is displayed during this test, please contact PROTEC service department or a service company authorized by them immediately.
  • Page 32: Safety And Maintenance

    (e.g. torn cable, bent parts) or if the resulting image quality (e.g. artifacts in the image) is insufficient. In this case, please contact PROTEC service department or a service company authorized by them immediately.
  • Page 33: Inspection And Maintenance

    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 whatsoever for damage to the user and third parties if damage results from inadequate or not carried out maintenance.
  • Page 34: Product Service Life

    The PRS 500 X is designed for a service life of 10 years when used in accordance with the specifications and regular maintenance by PROTEC service department or a service company authorized by them. After the product has reached the end of its service life, further use is at your own risk.
  • Page 35: Power Supply

    30 cm (12 in) to the marked parts and cables of the PRS 500 X. Failure to observe can lead to a reduction in the performance characteristics of the device. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 35 von 47...
  • Page 36: Guidelines And Manufacturers Declaration - Electromagnetic Interference

    Surges ± 1 kV ± 1 kV commercial or hospital EN 61000-4-5 environment. ± 2 kV ± 2 kV PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 36 von 47...
  • Page 37 1700 - 1990 DECT, 217 Hz 1970 LTE Band 1, 3, 4, 25, UMTS Bluetooth, Pulse modulation: 2450 2400 – 2570 WLAN, 802.11 217 Hz b/g/n, PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 37 von 47...
  • Page 38 PRS 500 X 5066-0-8002 Instructions for use RFID 2450, LTE Band 7 5240 Pulse modulation: 5500 5100 - 5800 WLAN, 802.11 a/n 217 Hz 5785 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 38 von 47...
  • Page 39: Technical Data

    V6.5_2024-04-12 PRS 500 X 5066-0-8002 Instructions for use Technical Data Dimensions PATIENT PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 39 von 47...
  • Page 40 V6.5_2024-04-12 PRS 500 X 5066-0-8002 Instructions for use PATIENT *OP – Operator PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 40 von 47...
  • Page 41: X-Ray Tube Support Stand

    Rotation X-ray tube unit around the +/- 180° horizontal tube column Detailed information please find in the enclosed Instructions for use, Technical Description of the PROGNOST SH. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 41 von 47...
  • Page 42: Image Receptor Stand

    7.6.1 Environmental Conditions during Operation Ambient temperature + 10°C to + 40°C Relative humidity 30% to 75% (non-condensing) Atmospheric pressure 700 hPa to 1060 hPa PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 42 von 47...
  • Page 43: Environmental Conditions For Shipping And Storage

    Environmental Conditions for Shipping and Storage Ambient temperature - 10°C to + 70°C Relative humidity 10% to 95% (non-condensing) Atmospheric pressure 500 hPa to 1060 hPa PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 43 von 47...
  • Page 44: Description Of Symbols, Labels And Abbreviations

    This symbol indicates the need to observe the instructions for use. This is provided in an electronic format (eIFU) on our website. www.protec-med.com/download Disposal instructions; WEEE (Waste of Electrical and Electronic Equipment) PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 44 von 47...
  • Page 45: Identification Label

    Transversal movement of the X-ray tube arm (optional) Electrical release for rotating the X-ray tube stand by ± 180° (optional) Identification label Exemplary for PRS 500 X with X-ray generator 50 kW PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 45 von 47...
  • Page 46: Labels

    Labels on the X-ray system tube support, floor stand and column X-ray system image receptor stand Product label Position symbols and labels At both ends of the rail Identification label PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 46 von 47...
  • Page 47: Abbreviations

    Abbreviations Abbreviations Millimetres Centimetres Kilogram °C Degree -Celsius Hectopascal German Industry Standard European Standard CE-Mark Hertz Duty cycle Ampere Serial number Volt (AC voltage) Kilowatt PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 47 von 47...

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