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RAPIXX DR-System
4336M1i X WiFi Set
4336V1i X WiFi Set
Digital X-ray detector system
Model/ID: 4999-9-0000_Vxxx (4336M1i X WiFi Set)
Basic UDI-DI: 426050264D001UX
Model/ID: 4563-9-1000 (4336V1i X WiFi Set)
Instructions for use & Installation Manual
ID no. 5513-0-9004
Responsible for assembling
of products to this system
according to Article 22 of Regulation (EU) 2017/745:
Version: 2.0
PROTEC GmbH & Co. KG
Issued: 2024-12-19
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 4336M1i X WiFi Set
- Page 1 Responsible for assembling of products to this system according to Article 22 of Regulation (EU) 2017/745: Version: 2.0 PROTEC GmbH & Co. KG Issued: 2024-12-19 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.
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Page 3: Table Of Contents
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 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 V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 Requirements before and during Operation ........................ 25 Operation ......................................25 6.2.1 Start-up order for daily use ............................25 6.2.2 Operation of the CONAXX 2 acquisition software ..................25 6.2.3 Operation of the detector with accessories ..................... 26 6.2.3.1 Battery handling and battery changing ......................
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Page 5: Revision Status
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: Radiation Warning
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: Device Description
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 40... -
Page 8: Hardware And Network System Requirements
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 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: Intended User Group
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: Safety Instructions
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: Explosion Protection
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: Installation
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: Checklist
RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 Checklist If the installation has already been prepared by PROTEC, only the following subchapters of this chapter need to be observed: • Fehler! Verweisquelle konnte nicht gefunden werden. Fehler! Verweisquelle konnte nicht gefunden werden. -
Page 14: Modification Of The X-Ray System (Trigger Mechanism)
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 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: Installation With Bucky Start
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 3.4.2 Installation with BUCKY START Connect the Bucky and the X-ray device to the INTERFACE BOX as marked on the connections. Procedure: 1. The power plug must not be plugged in. 2. -
Page 16: Connection Of The Components
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 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 16 of 40... -
Page 17: Connection Of The Anti-Scatter Grid Detection
5513-0-9004 Connection of the anti-scatter grid detection When using a PROTEC X-ray system (PRS 500 or PEDS 600) with built-in anti-scatter grid detection, this must be connected to the INTERFACE BOX. The following connections are provided for anti-scatter grid detection of the Bucky or Grid Entity:... -
Page 18: First Start Of Conaxx 2
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. 3.8.2 Licensing of CONAXX 2 After the restart of CONAXX 2 you will be informed that the license does not fit to your system. -
Page 19: Activation Of Conaxx 2 Modules
”. 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 20: Dose Indicator Settings For Detector
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 For detailed descriptions of the modules, please refer to the CONAXX 2 User Manual. Dose indicator settings for detector For each detector the document “RAPIXX calibration values” is included. Follow the instructions in the document to setup the dose indicator 20 of 40... -
Page 21: Calibration Of The Dr-System
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 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 120 cm. Make sure that the detector is completely irradiated (no collimation). -
Page 22: Control Elements And Displays
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 Control Elements and Displays Control Elements and Displays of the Detector Description Function Connection charging/power cable 24V DC connection Mode button Switching between different modes Display status Displays different status Display mode Displays different modes Display connection... -
Page 23: Display Status
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 5.1.4 Display Status Description Status Blue Detector switched off Green Exposure possible Error state For detailed information on the detector, please refer to the enclosed User Manual of the detector. Displays Battery Charging Station Display power supply Display charging process... - Page 24 V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 The battery still has at least 50% of its charge. The battery still has at least 25% of its charge. The battery still has at least 20% of its charge. The battery has less than 20% of its charge.
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Page 25: Handling
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 26: Operation Of The Detector With Accessories
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 6.2.3 Operation of the detector with accessories For detailed information of the detector, please refer to the enclosed original instructions UserManual_Mars1417X of the detector manufacturer. WARNING! If the detector of the 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 27: Function Of The Digital X-Ray Detector System
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 28: Troubleshooting While Connection Establishment
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 6.3.4 Troubleshooting while connection establishment If the connection cannot be established, it can be established manually in the toolbox in CONAXX 2. 1. Open „Toolbox“ ( 2. Press the „Disconnect“ button 3. -
Page 29: Using The Automatic Exposure Detection (Aed)
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 6.3.7 Using the Automatic Exposure Detection (AED) The detectors of the RAPIXX 4343M1i X WiFi series now have full-surface automatic exposure detection (AED). This means that no specific point within the detector needs to be exposed to trigger the AED function. -
Page 30: Safety And Maintenance
(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 31: Disinfection
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 32: Warranty
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 33: Power Supply
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 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 34: Technical Data
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 Technical Data Dimensions Detector Dimension (L x W x H): 460 mm x 384 mm x 15 mm Effective area: ca. 430 mm x 350 mm Front side (active side) Back side (inactive side) 34 of 40... -
Page 35: Technical Data Detector
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 Technical Data Detector Resolution 100 µm Scintillator Effective area ca. 430 mm x 350 mm Uniform load 300 kg Protection class IP56 Punctual load 150 kg on an area with 4 cm diameter Weight 3 kg incl. -
Page 36: Description Of Symbols, Labels And Abbreviations
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 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 37: Type Labels
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 38: Detector
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 10.2.2 Detector Example type label iRay Mars1417X detector 10.2.3 Battery charging station (charger) and detector battery Example type label iRay battery charging station Example type label iRay battery 38 of 40... -
Page 39: Interface Box
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 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 Mars1417X 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 40: Battery Charging Station
V2.0_2024-12-19 RAPIXX DR-System Instructions for use & Installation Manual 5513-0-9004 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 10.5 Abbreviations...
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