Protec PRS 500 E Instrcutions For Use

Protec PRS 500 E Instrcutions For Use

Basic diagnostic x-ray system
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PRS 500 E
Basic diagnostic X-ray system
Model/ID: 7069-9-8050
Instrcutions for use
Ident. Nr. 5069-0-8002
Version: 5.0
PROTEC GmbH & Co. KG
Issued: 2020-11-12
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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  • Page 1 PRS 500 E Basic diagnostic X-ray system Model/ID: 7069-9-8050 Instrcutions for use Ident. Nr. 5069-0-8002 Version: 5.0 PROTEC GmbH & Co. KG Issued: 2020-11-12 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 other or other use is prohibited without the express written authorization of PROTEC´s law department.
  • Page 3: Table Of Contents

    Operation at the X-ray system table ........................23 4.1.1.1 Position of patients on the tabletop ....................... 23 4.1.1.2 Setting the X-ray unit on the mid moving Bucky, Grid entity ............23 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 3 von 41...
  • Page 4 Environmental ....................................36 7.8.1 Environmental conditions during operation ....................36 7.8.2 Environmental Conditions for Shipping and Storage ................36 Description of symbols, labels and abbreviations ............37 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 4 von 41...
  • Page 5 PRS 500 E 5069-0-8002 Instructions for use Symbols ....................................... 37 Identification label..................................39 Labels ........................................39 Position symbols and labels ..............................40 Abbreviations ....................................41 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 5 von 41...
  • Page 6: Document Effectivity

    Telescopic arm added 2020-08-11 Front page, Cap. 5.3.3 Maintenance updated New generators, Cap. 1.2.1; Cap.6; Cap. 3.1.1; 2020-11-12 Rotatable X-ray column Cap. 3.1.2; Cap. 4.1.1.8 added PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 6 von 41...
  • Page 7: General Notes

    X-ray radiation. The intensity depends on the adjusted values of voltage, current and time. The radiation comes orthogonal out of the X-ray tube and is limited by the collimator. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 7 von 41...
  • Page 8: To The User

    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.
  • Page 9: Product Description

    This user manual describes the special features and operational aspects of the PRS 500 E, knowledge of which are required for efficient and effective use of the radiographic system. Prior to working with the PRS 500 E, it is required that the user reads the Safety Notes as well as the chapter regarding operation.
  • Page 10: Floor Capacity

    The radiographic system is primarily made of metal pieces. This has a main role in the weight of the device. The radiographic system PRS 500 E has a weight of 850kg (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.
  • Page 11: Intended Use

    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. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 11 von 41...
  • Page 12: Intended User Group

    Instructions for use Intended user group The radiographic system PRS 500 E 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.
  • Page 13: Safety Instructions

    Adjustments and calibrations that are described within the user manual must be made, with the aid of The technical description for the system, by the PROTEC GmbH & Co. KG customer service department or a PROTEC GmbH & Co. KG authorized service technician.
  • Page 14 It’s not allowed to make any medical not indicated exposures on people. At pregnancy or children the question is if the exposure is really necessary. If possible it’s better to abandon it. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 14 von 41...
  • Page 15: General Safety Notice

    Duty Cycle: S3 15% - maximum continuous operation of 1,5 minutes. 2.1.4 Operating personnel The radiographic system PRS 500 E with stand should only be operated by personnel who are trained in accordance with the corresponding national regulations in the use and operation of diagnostic radiographic systems.
  • Page 16: Pinching And Collision Hazards

    2.1.6 Explosion protection These radiographic system PRS 500 E is not designated for use within areas with explosive hazards. 2.1.7 Radiation protection X-ray radiation can pose a hazard to patients and other people when the regulations regarding the operation of radiographic systems are not followed.
  • Page 17: 2.1.10 Electromagnetic Environment And The Influence Of Devices

    The user must take remedial measures such as implementation or reorientation of the device. The PRS 500 E is intended for the usage in a professional environment of the medical service (e.g. clinic, surgery centers, physiology offices …) PROTEC GmbH &...
  • Page 18: Control Elements And Device Displays

    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 18 von 41...
  • Page 19 If the operating unit is equipped with handles, the electromagnetic lock of one or more movements can be released by thumb pressure on the keys of the operating unit and the tube head can be brought into the desired position. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 19 von 41...
  • Page 20 There is an increased risk of injury if the X-ray tube carrier is not engaged! Detailed information please find in the accompanying User Manual PROGNOST SH. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 20 von 41...
  • Page 21: Control Elements And Device Displays Collimator

    Detailed information please find in the enclosed User Manual of the X-ray generator. Control elements of Bucky, Grid entity Detailed information please find in the enclosed User Manual. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 21 von 41...
  • Page 22: Control Elements And Device Displays Of Vertical X-Ray System Image Receptor Stand Provert

    Detailed information please find in the enclosed User Manual of the RAPIXX system. Control elements and device displays of CONAXX 2 Detailed information please find in the enclosed User Manual of the CONAXX 2. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 22 von 41...
  • Page 23: Handling / Operation

    Press the desired Anatomically Programmed Radiography (APR) switch or manually select the desired exposure factors. Start the exposure by pressing the switches for exposure preparation/exposure release. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 23 von 41...
  • Page 24: Overtable Exposures

    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 24 von 41...
  • Page 25: Operation At Vertical X-Ray System Image Receptor Stand Provert

    (Exposure every 30 seconds, otherwise tube may arc). See User Manual Generator and CONAXX 2 User Manual chapter 5.3. Detailed information please find in the enclosed User Manual of the X-ray tube. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 25 von 41...
  • Page 26: Operation X-Ray Generator

    4.10 Function of the PRS 500 E 4.10.1 Switching On/Off the PRS 500 E Switching on the PRS 500 E happens via the control panel of the Generator. The Generator supplies every system component with power. On the Generator and the control panel will run a self-test when switching them on. After the self-test was successful the parameters will be displayed which can be saved under Organ-number #0.
  • Page 27: 4.11 Exposure Automatic

    If this happens properly the measured value will be displayed. If something is not running properly an Error message will be shown. Repeat this procedure for every measuring chamber. • The quickest exposure time of the Generator is 2ms. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 27 von 41...
  • Page 28: Safety And Maintenance

    Cleaning The use of corrosive or abrasive cleaning agents as well as solvents is not allowed. These materials can cause damage to the outer surface of the radiographic system PRS 500 E or to the coating of the individual components.
  • Page 29: Check-Up And Maintenance

    5.3.5 Product life time The PRS 500 E has an expected product life of 10 years when used in accordance with the product specifications/ limitations and provided that maintenance through the PROTEC service department or a PROTEC authorized service provider has be completed. After reaching the life span the further usage of the device happens on own risk.
  • Page 30: Applied Parts And Parts Which Get Handled Like An Application Part

    5.3.8 Disposal The X-ray system PRS 500 E contains different plastics, oils and heavy metal. At disposal of exchange parts or the whole system the current regulations have to be observed. Please contact the service or a company specialized for disposing the components.
  • Page 31: Electrical Data

    50/60 Hz Electrical resistance per 0,15Ω 0,15Ω 0,15Ω phase 0,17Ω 0,17Ω 0,17Ω 0,20Ω 0,20Ω 0,20Ω 0,24Ω 0,24Ω 0,24Ω Fuse 50A / 480V List (Power supply generator) PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 31 von 41...
  • Page 32: Electromagnetic Compatibility (Emc) After En 60601-1-2

    CAUTION! Mobile HF-Communication devices shouldn’t be used closer than 30cm (12 Inch) to the marked parts and cables of the PRS 500 E. Disregarding this can cause a decrease in the performance features of the device. CAUTION! The X-ray generator integrated into the radiographic system PRS 500 E sends out electromagnetic waves during operation, which could cause interference with other devices.
  • Page 33: Technical Data

    PRS 500 E 5069-0-8002 Instructions for use Technical Data Dimensions PATIENT PATIENT PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 33 von 41...
  • Page 34 PRS 500 E 5069-0-8002 Instructions for use PATIENT *OP – Operator PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 34 von 41...
  • Page 35: X-Ray System Table Prognost E

    The Bucky, Grid entity and the measure chambers are connected to the generator. Detailed information please find in the enclosed User Manual, Technical Description of the PROVERT. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 35 von 41...
  • Page 36: Attenuation Equivalent

    0,4 and < 0,5 Al mm according to EN 60601-1-3. Tested at 100 kV with a first half-value layer thickness (HVLT) of 3,7 mm Al. 7.6.1 Protection Art and Protection Class The PRS 500 E is consistent with a protection class 1 device and contains applicable parts Type B (according to EN 60601-1).Environmental conditions. Automatic cutoff dose 7.7.1 Analogue System The automatic cutoff dose is 2.5 µGy.
  • Page 37: Description Of Symbols, Labels And Abbreviations

    Homepage www.protec-med.com/download Notes on disposal; WEEE , Waste of Electrical and Electronic Equipment Protective ground (Earth) Caution: pinch-/crushing hazard for hands and fingers PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 37 von 41...
  • Page 38 Vertical movement of the X-ray tube arm Rotation of the X-ray tube assembly Horizontal movement of the X-ray system tube support, floor stand and vertical movement of the X-ray tube assembly PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 38 von 41...
  • Page 39: Identification Label

    X-ray tube assembly unit. Labels on the X-ray system tube support, floor stand and column X-ray system image receptor stand Product label PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 39 von 41...
  • Page 40: Position Symbols And Labels

    Label on the front plate x-ray system table Company label Position symbols and labels At both ends of the rail Identification label Identification label Identification label PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 40 von 41...
  • Page 41: Abbreviations

    5069-0-8002 Instructions for use Abbreviations Millimetres Centimetres Pound Kilogram °C Degree -Celsius Hectopascal German Industry Standard European Standard CE-Mark Hertz Duty cycle Ampere Serial number PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 41 von 41...

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