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RAPIXX DR System
3325V1i X WiFi Set
Digital X-ray detector system
Model/ID: 4567-9-1000
Instructions for Use & Installation Manual
ID no. 5567-0-0002
PROTEC GmbH & Co. KG
Version: 1.0
In den Dorfwiesen 14, 71720 Oberstenfeld, Germany
Issued: 2023-07-26
Telephone: +49 (0) 7062/92 55-0 E-Mail: protec@protec-med.com
Subject to alterations
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Summary of Contents for Protec RAPIXX DR System 3325V1i X WiFi Set
- Page 1 Digital X-ray detector system Model/ID: 4567-9-1000 Instructions for Use & Installation Manual ID no. 5567-0-0002 PROTEC GmbH & Co. KG Version: 1.0 In den Dorfwiesen 14, 71720 Oberstenfeld, Germany Issued: 2023-07-26 Telephone: +49 (0) 7062/92 55-0 E-Mail: protec@protec-med.com Subject to alterations...
- 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
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 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_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 Introduction ...................................... 25 Reusability ......................................25 Cleaning and Disinfection ................................ 25 7.3.1 Cleaning ....................................25 7.3.2 Disinfection ................................... 26 Inspection and maintenance ..............................26 7.4.1 Daily Monitoring before and during the Examination Operation............26 7.4.2 Regular Monitoring ................................
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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 36... -
Page 8: Hardware And Network System Requirements
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. PROTEC GmbH & Co. KG In den Dorfwiesen 14 | 71720 Oberstenfeld Germany Phone: (+ 49) 7062 –... -
Page 9: 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 10: 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 11: 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 12: Checklist
RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 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 13: Connection Of The Components
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 Connection of the components Connect the components as described in the following schematic diagram. WLAN connection establishment with the detector If the WLAN adapter built into the computer is used for a direct connection to the panel and not an Access Point, the WLAN connection must be established once to the detector. -
Page 14: First Start Of Conaxx 2
ETECTION 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. 3.6.2 Licensing of CONAXX 2 After the restart of CONAXX 2 you will be informed that the license does not fit to your system. -
Page 15: 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 16: Dose Indicator Settings For Detector
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 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. -
Page 17: Calibration Of The Dr System
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 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 18: Control Elements And Displays
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 Control Elements and Displays Control Elements and Displays of the Detector Description Function Display status Displays different status Display connection Displays connection status Display power supply Displays power supply Switch on/off button Switching the detector on and off Connection charging/power cable 24V DC connection... -
Page 19: Displays Battery Charging Station
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 Displays Battery Charging Station Display power supply Display charging process Display fully charged battery LEDs Description Status All off No power supply - power supply Display - multiple batteries inserted Display Self-test on battery insertion flashing alternately 2 times... - Page 20 V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 The connection to the detector is interrupted. No X-ray exposure is possible. X-ray generator: This function opens the x-ray generator control. X-ray exposures can be made without taking images via the modality. For detailed information of the CONAXX 2 acquisition software, please refer to the CONAXX 2 User Manual.
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Page 21: 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 22: Operation Of The Detector With Accessories
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 6.2.3 Operation of the detector with accessories For detailed information of the detector, please refer to the enclosed original instructions UserManual_Luna1013XE 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 23: Switch-On Order For Battery Changing
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 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 24: Modality Errors During Operation
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 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 25: 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 26: 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 27: 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 28: Power Supply
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 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. 28 of 36... -
Page 29: Technical Data
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 Technical Data Dimensions Detector Dimension (L x W x H): 362.4 mm x 269.35 mm x 14.5 mm Effective area: ca. 331.8 mm x 252.8 mm Front side (active side) Back side (inactive side) 29 of 36... -
Page 30: Technical Data Detector
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 Technical Data Detector Resolution 100 µm Scintillator Effective area ca. 331.8 mm x 252.8 mm Protection class IP67 Weight 2.285 kg incl. battery 2.4 GHz ≤ 35 MHz WLAN Band 5 GHz ≤... -
Page 31: Description Of Symbols, Labels And Abbreviations
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 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 IPxx Protection type This way up Attention, observe accompanying documents Refer to Instructions for use... -
Page 32: 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 33: Detector
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 10.2.2 Detector Example type label iRay Luna1013XE detector 10.2.3 Battery charging station (charger) and detector battery Example type label iRay battery charging station Example type label iRay battery 33 of 36... -
Page 34: Interface Box
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 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 Positions of the Signs and Labels 10.3.1 Detector The type labels are located on the underside of the detector. -
Page 35: Battery Charging Station
V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 10.3.2 Battery charging station The type label is located on the underside of the battery charging station. 10.3.3 Battery The type label is printed on the bottom of the battery. 10.3.4 INTERFACE BOX The type labels are located on the underside of the INTERFACE BOX 10.4 Abbreviations... - Page 36 V1.0_2023-07-26 RAPIXX DR-System Instructions for use & Installation Manual 5567-0-0002 CE-Mark Hertz Ampere Serial number Electromagnetic compatibility High frequency LP/mm Line pairs per millimeter Cesium iodide International Protection 36 of 36...
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