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Summary of Contents for Protec PRS 500 C
- Page 1 PRS 500 C Basic diagnostic X-ray system Model/ID: 7073-9-8050 Instructions for use Ident. No. 5073-0-3002 Version: 4.0 PROTEC GmbH & Co. KG Issued: 2021-03-11 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.
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Page 3: Table Of Contents
PRS 500 C 5073-0-3002 Instructions for use Table of contents Page Table of contents ........................... 3 Document Effectivity ........................6 General Notes ..........................7 Mechanical – Electric Warning ....................7 Radiation Warning ........................7 To the User ............................. 8 Product description ......................9 Introduction ...................................... - Page 4 Operation X-ray generator ............................... 23 Operation Bucky, Grid entity ..............................23 Operation RAPIXX system................................. 23 Operation Software ..................................23 Switching On/Off the PRS 500 C ............................23 4.8.1 Power Box ....................................24 4.8.2 Dosimetric Calibration VENUS, CMP, RFX generators ................. 24 Exposure automatic ..................................
- Page 5 PRS 500 C 5073-0-3002 Instructions for use Labels ........................................34 Position symbols and labels ..............................35 Abbreviations ....................................35 5 von 35...
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Page 6: Document Effectivity
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 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 in the instructions for use for the generators, X-ray tubes and collimators. -
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
Prior to working with the basic diagnostic X-ray system PRS 500 C, it is required that the user read the safety notes as well as the chapter regarding operation. -
Page 10: Installation
The X-ray system is primarily made of metal pieces. This has a main role in the weight of the device. The X-ray system PRS 500 C has a weight of 665 kg (incl. Generator). Every technician is obliged to check the ground load. Also double bottoms and hollow floors have to be taken into account. -
Page 11: Vertical Bucky Wall Stand
PRS 500 C 5073-0-3002 Instructions for use 1.3.3 Vertical Bucky Wall 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”... -
Page 12: Contra Indications
Intended user group The radiographic system PRS 500 C 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 (certified) use in connection with other medical products, 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 PRS 500 C 5073-0-3002 Instructions for use NOTE Every operating element is marked on the operating console and on the swivel arm or wall column, there are further descriptions for the symbols in the corresponding manual. The lawfully requirements for building regulations for X-ray systems have to be fulfilled.
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Page 15: General Safety Notice
PROTEC or an authorized service and stop the using of the system. 2.1.3 Operating personnel The radiographic system PRS 500 C 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 X- Ray systems. -
Page 16: Pinching And Collision Hazards
PRS 500 C 5073-0-3002 Instructions for use 2.1.4 Pinching and Collision Hazards CAUTION! Ensure that while using any product that can be lowered, raised or moved in different directions, neither yourself (operator), the patient or any third party finds themselves in a hazardous position (area of movement). Remove all objects (e.g. -
Page 17: Electromagnetic Environment And The Influence Of Devices
The user must take remedial measures such as implementation or reorientation of the device. The PRS 500 C is intended for the usage in a professional environment of the medical service (e.g. clinic, surgery centers, physiology offices …) -
Page 18: Control Elements And Device Displays
PRS 500 C 5073-0-3002 Instructions for use Control elements and device displays Control elements and device display of Basic X-ray system 3.1.1 Floor railed X-ray system tube support Rail Slide Tube Rotation All Free Tube UP/DOWN Rail Slide When operator wants to move the tube stand at desired position horizontally, it can be moved manually while holding this button. -
Page 19: Radiographic Table
PRS 500 C 5073-0-3002 Instructions for use 3.1.2 Radiographic table WARNING! The positioning and support of a patient on the X-ray system table must not be carried out without an X-ray mattress! Power ON/OFF All Free Switch, light barrier The red line in the figure is the "ALL-FREE" switch. By bringing a foot or any object in this area, the "ALL-FREE"... -
Page 20: Control Elements And Device Displays Collimator
PRS 500 C 5073-0-3002 Instructions for use Control elements and device displays collimator Figure collimator ML03 Pos. 1 -> Knobs for height format collimation (Rotating counterclockwise to open the collimator, rotating clockwise closes the collimator). Pos. 2 ->Knobs for width format collimation (Rotating clockwise to open the collimator, rotating counterclockwise closes the collimator). -
Page 21: Handling / Operation
PRS 500 C 5073-0-3002 Instructions for use Handling / Operation Operation with the radiographic system 4.1.1 Operation at the X-ray table 4.1.1.1 Position of patients on the table top WARNING! The positioning and support of a patient on the X-ray system table must not be carried out without an X-ray mattress! •... -
Page 22: Overtable Exposures
PRS 500 C 5073-0-3002 Instructions for use 4.1.1.7 Overtable exposures • Place a cassette to the desired position on the table top. • Move X-ray tube to the desired position and adjust SID. • Press the collimator light switch (button 3, figure collimator) to turn on the collimator light, and view the opening of the collimator shutters in both axes relatives to the cassette and object size. -
Page 23: Operation X-Ray Tube
Detailed information please find in the enclosed installation- and User Manual CONAXX 2. Switching On/Off the PRS 500 C Switching on the PRS 500 C happens via the control panel of the Generator. The Generator supplies every system component with power. -
Page 24: Power Box
Detailed information please find in the enclosed documentation of the generator. Exposure automatic If the PRS 500 C is operated with an exposure automatic the functionality can be checked like this: Place a Phantom or any other weakening object in the radiation way. Choose a measuring chamber and expose. -
Page 25: Safety And Maintenance
PRS 500 C 5073-0-3002 Instructions for use Safety and Maintenance WARNING! Caution electrocution hazard! Prior to cleaning or disinfection, switch of the X-Ray generator. As a result, the radiographic system will be disconnected from power and the danger of electric shock is eliminated. -
Page 26: Check-Up And Maintenance
5.3.5 Product life time The PRS 500 C 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 26 von 35... -
Page 27: Further Information
PROTEC authorized service provider has be completed. After reaching the life span the further usage of the device happens on own risk. Individual parts, components of the PRS 500 C may have a shorter product life time or should be replaced at shorter intervals for safety reasons. These parts, components and their required measures can be found in the maintenance checklist of the PRS 500 C Technical Description. -
Page 28: Electrical Data
Input current 2,5 A It is intended that the central power supply of the PRS 500 C is always be connected to an 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 above. -
Page 29: 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 C. Disregarding this can cause a decrease in the performance features of the device. CAUTION! The X-Ray generator integrated into the radiographic system PRS 500C sends out electromagnetic waves during operation, which could cause interference with other devices. -
Page 30: Technical Data
PRS 500 C 5073-0-3002 Instructions for use Technical Data Dimensions PATIENT PATIENT 30 von 35... -
Page 31: X-Ray System Table
PRS 500 C 5073-0-3002 Instructions for use X-ray system table Table top dimension (L x B): 2280 mm x 800 mm, standard Safe patient weight, max 200 kg Safe working load (without X-ray mattress), max 250 kg Table top height: 700 mm ±... -
Page 32: Attenuation Equivalent
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 C 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... -
Page 33: Description Of Symbols, Labels And Abbreviations
PRS 500 C 5073-0-3002 Instructions for use Description of symbols, labels and abbreviations Symbols Keep dry Fragile, Handle with care This way up Caution, note warning notice and safety instructions Refer to user manual CE-Mark Classification according to EN 60601-1 (Type B) -
Page 34: Identification Label
Product label Label on the X-ray mattress The X-ray mattress is identified as a component of the PRS 500 C. The positioning and support of a patient on the X-ray system table must not be carried out without this mattress! - Page 35 PRS 500 C 5073-0-3002 Instructions for use Position symbols and labels Identification label Label of the X-ray mattress The label is located on the underside of the X-ray mattress. Abbreviations Millimetre Centimetre Pound Kilogram °C Degree -Celsius Hectopascal German Industry Standard...
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