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PRS 500 E
Basic diagnostic X-ray system
Model/ID: 7069-9-8050_Vxxx
Basis UDI-DI: 426050264X005ZK
Instructions for use
Ident. Nr. 5069-0-8002
Version: 6.0
PROTEC GmbH & Co. KG
Issued: 2022-01-19
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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Related Manuals for Protec PRS 500 E
Summary of Contents for Protec PRS 500 E
- Page 1 Basic diagnostic X-ray system Model/ID: 7069-9-8050_Vxxx Basis UDI-DI: 426050264X005ZK Instructions for use Ident. Nr. 5069-0-8002 Version: 6.0 PROTEC GmbH & Co. KG Issued: 2022-01-19 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.
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Page 3: Table Of Contents
Control Elements and Display of X-ray tube ......................... 23 Control Elements and Display of X-ray generator ..................... 23 Control Elements of Bucky, Grid entity ..........................23 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 3 von 47... - Page 4 Guidelines and Manufacturer’s Declaration – Electromagnetic interference ......34 Technical Data ........................37 Dimensions ......................................37 X-ray system table PROGNOST E ............................39 Bucky, Grid entity ................................... 39 X-ray tube column ..................................40 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 4 von 47...
- Page 5 Description of symbols, labels and abbreviations ............42 Symbols ....................................... 42 Identification label..................................44 Labels ........................................44 Position symbols and labels ..............................46 Abbreviations ....................................47 PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 5 von 47...
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Page 6: Revision Status
1.2.2; Kap. 1.2.2.1; Kap. Rotation; Note Installation 1.3.2; Kap. 7.1 new; total weight changed; ceiling height changed; Traverse paths PROGNOST SH changed vertically; translation cpl. revised PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 6 von 47... -
Page 7: 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 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: Device Description
The instructions for use describe the performance characteristics and operation required for efficient and effective use of the PRS 500 E. Before working with the PRS 500 E, the complete instructions for use must be read, especially the Safety Instructions and the chapter Handling. -
Page 10: Installation
The installation of the PRS 500 E must be performed by PROTEC service department or a service company authorized by them. This X-ray system PRS 500 E must be installed in a shielded X-ray room that complies with the national regulations on radiation protection. -
Page 11: X-Ray Tube Support Stand
For diagnostic of malformations and malalignments of the skeletal system. • For the diagnosis of thoracic and pulmonary symptoms (thorax exposures) • For the diagnosis of sclerotherapy. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 11 von 47... -
Page 12: Indication And Contraindication
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 12 von 47... -
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 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 14 von 47...
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Page 15: 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 E anymore and notify PROTEC service department or a service company authorized by them. 2.1.2.1 Operating Type The PRS 500 E is not intended for continuous operation. -
Page 16: Crushing And Collision Hazard
It must be ensured that when operating the moving parts of PRS 500 E, no persons or objects are in the obvious danger area of the device. If not observed, it can result in personal injury or damage to the PRS 500 E or other objects. -
Page 17: Electromagnetic Environment And The Influence Of Devices
The user may need to take remedial measures such as relocating or realigning the device. The PRS 500 E is intended for use in an environment in professional health care facilities (e.g. clinics, surgery centres, physiology practices ...). -
Page 18: Control Elements And Displays
Main Switch of the X-ray system The PRS 500 E 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: Emergency Stop Switches Of The X-Ray System
Instructions for use Emergency Stop Switches of the X-ray system The PRS 500 E has the following emergency stop switches, which can be used to bring the device to an immediate standstill and disconnect it from the power supply. 3.2.1... -
Page 20: 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 20 von 47... -
Page 21: 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 21 von 47... -
Page 22: Control Elements And Display Of Collimator
Pos. 8 -> Scales; indicate the opening of collimator shutters (longitudinally to table top). Pos. 9 -> Collimator light switch; turns on collimator light. Pos. 10 -> Measuring tape. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 22 von 47... -
Page 23: Control Elements And Display Of X-Ray Tube
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 23 von 47... -
Page 24: 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. 3.11 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 24 von 47... -
Page 25: Handling / Operation
X-ray filed can be limited to the desired cassette size in both axes. Adjust cassette size as required using the collimator adjustment controls. Reduce shutter openings to objects size for better image quality. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 25 von 47... -
Page 26: Exposure Preparation / Exposure Release
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 26 von 47... -
Page 27: Operation At Vertical X-Ray System Image Receptor Stand Provert
Detailed information please find in the enclosed User Manual of the PROGNOST E. Operation of the collimator Detailed information please find in the enclosed User Manual of the collimator. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 27 von 47... -
Page 28: Operation Of The X-Ray Tube
4.11.1 Switching the PRS 500 E on and off The PRS 500 E is switched on via the console of the generator. All system components are supplied with voltage via the generator. If the system contains a Power Box, the power is supplied via the Power Box. -
Page 29: 4.12 Automatic Exposure Control
Instructions for use 4.12 Automatic Exposure Control If the PRS 500 E is operated with an automatic exposure control, the functionality can be checked as follows: Place a phantom or any other weakening object (not lead) in the beam path. Select the measurement chamber field to be checked and trigger the exposure. -
Page 30: Safety And Maintenance
(see also chapter 4.1). The PRS 500 E 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. -
Page 31: Inspection And Maintenance
(e.g. Dr. Schumacher Descosept Sensitive Wipes). All mechanical parts of the PRS 500 E, including accessories, may only be cleaned with a wipe disinfection with suitable surface disinfectants (e.g. Melsept® SF, 15 min. application time at 2% concentration). -
Page 32: Product Service Life
5.4.5 Product Service Life The PRS 500 E 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 33: Power Supply
Portable RF communication devices (radio devices) should not be used closer than 30 cm (12 in) to the marked parts and cables of the PRS 500 E. Failure to observe can lead to a reduction in the performance characteristics of the device. -
Page 34: Guidelines And Manufacturer's Declaration - Electromagnetic Interference
Guidelines and Manufacturer’s Declaration – Electromagnetic interference The PRS 500 E 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 35 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 35 von 47...
- Page 36 PRS 500 E 5069-0-8002 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 36 von 47...
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Page 37: 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 37 von 47... - Page 38 PRS 500 E 5069-0-8002 Instructions for use PATIENT *OP – Operator PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 38 von 47...
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Page 39: 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 Bucky, Grid entity. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 39 von 47... -
Page 40: X-Ray Tube Column
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 40 von 47... -
Page 41: Attenuation Equivalent
EN 60601-1-3 at 100kV and a first half-value layer thickness of 3.6 mm Al. 7.6.1 Protection Art and Protection Class The PRS 500 E corresponds to protection class 1 and contains applied parts type B (according to EN 60601-1). Automatic Cut-off Dose 7.7.1... -
Page 42: 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) Protective earthing PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 42 von 47... - Page 43 Release tabletop brakes Horizontal movement of the X-ray system tube support, floor stand Vertical movement of the X-ray tube arm Rotation of the X-ray tube assembly PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 43 von 47...
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Page 44: Identification Label
Labels on top of the tabletop and/or tube arm Caution: Possible pinch-/crushing hazard fort he hands and fingers while moving the tabletop, table and or X-ray tube assembly unit. PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 44 von 47... - Page 45 Labels on the X-ray system tube support, floor stand and column X-ray system image receptor stand Product label Label on the front plate x-ray system table Company label PROTEC GmbH & Co. KG, In den Dorfwiesen 14, 71720 Oberstenfeld, Germany 45 von 47...
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Page 46: Position Symbols And Labels
PRS 500 E 5069-0-8002 Instructions for use 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 46 von 47... -
Page 47: 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 47 von 47...
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