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Protec RAPIXX DR-System 12043M1i WiFi Set Instructions For Use & Installation Manual

Digital x-ray detector system
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RAPIXX DR-System
12043M1i WiFi Set
Digital X-ray detector system
Model/ID: 4999-9-0000_Vxxx
Basis UDI-DI: 426050264D001UX
Instructions for Use & Installation Manual
ID no. 5526-0-9004
Responsible for assembling
of products to this system
according to Article 22 of Regulation (EU) 2017/745:
Version: 1.0
PROTEC GmbH & Co. KG
Issued: 2024-10-16
In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
Subject to alterations
Phone: +49 (0) 7062/92 55-0 E-mail: protec@protec-med.com

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Summary of Contents for Protec RAPIXX DR-System 12043M1i WiFi Set

  • Page 1 Responsible for assembling of products to this system according to Article 22 of Regulation (EU) 2017/745: Version: 1.0 PROTEC GmbH & Co. KG Issued: 2024-10-16 In den Dorfwiesen 14, 71720 Oberstenfeld, Germany Subject to alterations Phone: +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 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Table of contents Page Table of contents ........................... 3 Revision Status ..........................5 Radiation Warning ........................6 To the User ............................. 6 Device Description ......................7 Introduction ......................................7 Description......................................7 1.2.1 System Components .................................
  • Page 4 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Operation ......................................23 6.2.1 Start-up order for daily use ............................23 6.2.2 Operation of the CONAXX 2 acquisition software ..................23 6.2.3 Operation of the detector with accessories ..................... 24 6.2.3.1 Battery handling and battery changing ......................
  • Page 5 Revisions made after the delivery are incorporated in a new version of this document. Current versions of the document can be accessed at any time via the PROTEC website.
  • Page 6 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 7 Network cable (take note of the max. cable length in the component documents) • RAPIXX data connection cable (take note of the max. cable length in the component documents) • WLAN router or Access Point (only use devices approved by PROTEC) 7 of 39...
  • Page 8 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 1.2.2 Hardware and Network System Requirements When using the digital X-ray detector system, it should be ensured that the country-specific requirements for data protection and IT security are met. The system requirements for the optional system components (RAPIXX-series) can be found in the current document supplied, "EN_5330-0-0026_CONAXX2_System_Requirements”.
  • Page 9 1.10 Declaration according to Article 22 The declaration according to article 22 of regulation (EU) 2017/745 is available upon request from: PROTEC GmbH & Co. KG In den Dorfwiesen 14 | 71720 Oberstenfeld Germany Phone: (+ 49) 7062 –...
  • Page 10 General Safety Instructions 2.1.1 Device Operation In case of a malfunction, do not use the digital X-ray detector system anymore and notify PROTEC service department or a service company authorized by them. 2.1.1.1 Operating Type The digital X-ray detector system is intended for continuous operation.
  • Page 11 CAUTION! The use of other accessories, other converters and other cables than those specified by PROTEC or provided in the documentation of the component manufacturer can result in increased electromagnetic interference or reduced electromagnetic immunity of the device and lead to defective operation.
  • Page 12 Therefore, the grid to be used should be coordinated with PROTEC GmbH & Co. KG in advance. WARNING! PROTEC GmbH & Co KG assumes no liability for the selection of the anti- scatter grid. WARNING! If the detector of the RAPIXX DR-system is operated via data cable and with direct patient contact, it must be ensured that the data cable is equipped with a network isolator in accordance with EN 60601-1.
  • Page 13 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Checklist If the installation has already been prepared by PROTEC, only the following subchapters of this chapter need to be observed: • 3.4 Modification of the X-ray system (trigger mechanism) •...
  • Page 14 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Modification of the X-ray system (trigger mechanism) When using the INTERFACE BOX, it must be connected to the X-ray system. 3.4.1 Installation with hand switch Connect the hand switch and the X-ray device to the INTERFACE BOX as marked on the connections. Procedure: 1.
  • Page 15 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Connection of the components Connect the components as described in the following schematic diagram. 3.5.1 Operation with automatic exposure detection (AED) 3.5.2 Operation with INTERFACE BOX 15 of 39...
  • Page 16 ” option can be activated. RID CORRECTION NOTE The acquisition time window of the detector is 1000 milliseconds at delivery. If a longer acquisition time window is required for the X-ray images, please contact PROTEC's support Afterwards restart CONAXX 2. 16 of 39...
  • Page 17 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 3.7.2 Licensing of CONAXX 2 After the restart of CONAXX 2 you will be informed that the license does not fit to your system. Confirm this message. NOTE For the licensing procedure it is necessary that CONAXX 2 can communicate with the connected detector.
  • Page 18 ”. Download the license afterwards with “G ”. For the licensing by E-mail, send the hardware key to mis@protec-med.com. You will then get the valid license key by E-mail. This license file must be imported in the section “S > R ”...
  • Page 19 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Calibration of the DR-System NOTE For the calibration make sure that the detector runs at least 2 hours. General notes for calibration: Set the required SID of the detector manufacturer to 300 cm. Make sure that the detector is completely irradiated (no collimation).
  • Page 20 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Control Elements and Displays Control Elements and Displays of the Detector Description Function LED Power indicator Displays the operating status of the detector LED Link indicator Displays the connection of the detector LED Status indicator Displays the status of the detector LED Mode indicator...
  • Page 21 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 5.2.3 Display Status (C) Description Status a) Detector switched off b) Exposure prohibited Green (steady) Exposure enabled a) Image is being transmitted Green (flashing) b) Initializing Orange (steady) Error occurred 5.2.4 Display Mode (D) Description...
  • Page 22 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Control Elements and Displays of the CONAXX 2 Acquisition Software This area provides status information and tools for various components in the CONAXX 2 main window: System: This function shows status information of the system. This includes, for example, information about hard disk capacities.
  • Page 23 X-ray system must be restarted and a test exposure must be taken without patient. Only if the exposure is correct, the system can be used again properly. If the test exposure is still defective, please contact PROTEC customer service or a service authorized by them. Operation 6.2.1...
  • Page 24 If no connection can be established, proceed as described in the section “Troubleshooting while connection establishment”. NOTE During usage of the PROTEC detector charging function, the detector is automatically switched on if it is placed in the drawer and the X-ray system is switched on.
  • Page 25 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 2. CONAXX 2 software The software can be shut down via the “Exit” menu item in the main menu. 6.3.3 Switch-on order for battery changing 1. Switch off the detector 2.
  • Page 26 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 If the connection to the X-ray generator is interrupted during operation with CONAXX 2, it must be restarted. A new connection attempt is not initiated until the restart. If no error message appears during the restart, the connection was established correctly and the generator can be used.
  • Page 27 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 6.3.7 Positioning the organ when using automatic exposure detection (AED) WARNING! To ensure the function of the automatic exposure detection (AED), the following factors must be observed for each X-ray exposure: •...
  • Page 28 (e.g., missing, defective or 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 29 7.4.3 Maintenance The required maintenance must be carried out by PROTEC service department or a service company authorized by them in order to ensure the safe and reliable functionality of the device. The maintenance intervals depend on the frequency of use. Prior to the examination operation, the user must satisfy himself that all appliances listed in the operating instructions and serving safety are in working order and that the RAPIXX DR-system is ready for operation.
  • Page 30 Wear parts must be replaced with original parts. NOTE In the case that the required maintenance is not completed as intended, PROTEC GmbH & Co. KG is no longer responsible for injuries to the operator and third parties, provided that the damage is the result of improper or missing maintenance.
  • Page 31 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Power Supply WARNING! To avoid the risk of an electric shock, this device may only be connected to a supply network with a protective earth conductor. Electromagnetic Compatibility (EMC) according to EN 60601-1-2 CAUTION! As a medical electrical device, the components of the RAPIXX DR-system are subject to special precautionary measures regarding EMC and must be...
  • Page 32 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Technical Data Dimensions Detector Dimension (L x W x H): 1271.4 mm x 586.6 mm x 20.8 mm Front side (active side) sidewise Back side (inactive side) Technical Data Detector Resolution 139 µm Scintillator...
  • Page 33 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Protection Type and Protection Class For detailed instructions on the protection type and protection class, refer to the enclosed original instructions for the system components. Automatic Cut-off dose The recommended automatic cut-off dose on the X-ray system with the digital X-ray detector system is 2.7 µGy.
  • Page 34 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Description of Symbols, Labels and Abbreviations 10.1 Symbols Atmospheric pressure limit Temperature limit Humidity limit Keep dry Protect from sunlight Fragile, handle with care Handle with care Punctual load (Ø 4cm) IPxx Protection type This way up...
  • Page 35 Classification according to EN 60601-1 (type B applied part) 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)
  • Page 36 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 10.2.2 Detector Example type label iRay Venu1748V detector 10.2.3 Battery charging station (charger) and detector battery Example type label iRay battery charging station Example type label iRay battery 36 of 39...
  • Page 37 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 10.2.4 INTERFACE BOX Example type label INTERFACE BOX 10.2.5 CONAXX 2 Example type label CONAXX 2 Example specification in the CONAXX 2 interface 10.3 Labels 10.3.1 Detector Label imprint on surface iRay Venu1748V detector 10.4 Positions of the Signs and Labels 10.4.1 Detector The type labels are located on the underside of the detector.
  • Page 38 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 Der Hinweise-Aufdruck befindet sich auf der Oberfläche des Detektors. 10.4.2 Battery charging station The type label is located on the underside of the battery charging station. 10.4.3 Battery The type label is printed on the bottom of the battery. 10.4.4 INTERFACE BOX The type labels are located on the underside of the INTERFACE BOX.
  • Page 39 V1.0_2024-10-16 RAPIXX DR-System Instructions for use & Installation Manual 5526-0-9004 10.5 Abbreviations Millimeter Centimeter Meter µm Micrometer µGy Microgray Kilogram °C Degree - Celsius Hectopascal German Industry Standard European Standard CE-Mark Hertz Ampere Serial number Electromagnetic compatibility High frequency LP/mm Line pairs per millimeter Cesium iodide International Protection...