R-Biopharm RIDA qLine Scan User Manual
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Summary of Contents for R-Biopharm RIDA qLine Scan

  • Page 1 RIDA qLine Scan ® User Manual https:/ /clinical.r-biopharm.com...
  • Page 2 RIDA qLine® Scan | User Manual...
  • Page 3 Art. No. ZG1109: Version 2022-04-08 Copyright 2022 by R-Biopharm AG © R-Biopharm AG reserves the right to modify its products and services at any time. This guide is subject to change without notice. Although prepared to ensure accuracy, R-Biopharm AG assumes...
  • Page 4: Table Of Contents

    RIDA qLine® Scan | User Manual Content QC test using Warnings, Cautions and notes RIDA qLine® Soft Labels Safety instructions Image creation with RIDA qLine® Scan General information Placing the test Intended purpose Erroneous image Functions acquisition Device specifications and requirements Turn off the reader 2.3.1 Specifications 2.3.2 Requirements...
  • Page 5: Warnings, Cautions And Notes

    Failure to comply with the instructions in this manual will void the manufacturer’s warranty and may pose a risk to the user. Ensure all users are conversant with the instrument - contact R-Biopharm AG for any further instrument or training requirements if in any doubt before using the instrument.
  • Page 6: Labels

    RIDA qLine® Scan | User Manual Labels Symbol Description RIDA qLine® Scan Product branding In vitro diagnostic medical device Reference number Caution WEEE Waste Electrical and Electronic Equipment WEEE Waste Electrical and Electronic Equipment Refer to user manual Manufacturer Date of manufacturing RIDA qLine®...
  • Page 7: Safety Instructions

    1 Safety instructions • The device is intended for use by professional users only. • The guidelines for work in medical laboratories must be observed. • The operating instructions for the devices must be strictly observed. • Please handle this equipment carefully at all times. •...
  • Page 8: General Information

    RIDA qLine® Scan | User Manual 2 General information 2.1 Intended purpose For in-vitro diagnostic use. The RIDA qLine® Scan reader creates scanned images of the RIDA qLine® Allergy test membranes. RIDA qLine® Soft must be used for operation in compliance with in-vitro diagnostic use and for further processing of the images.
  • Page 9: Device Specifications And Requirements

    2.3 Device specifications and requirements Fig. 1: Open Drawer 2.3.1 Specifications Parameter Specifications General weight 2.9 kg Plastic contents 2 parts of body housing Drawer mechanical drawer Power Supply 1 x external power supply Mod. 3A-183WP24 Input 100V – 240V 50-60 Hz, 0.6 A Output 24V –...
  • Page 10: Requirements

    RIDA qLine® Scan | User Manual 2.3.2 Requirements Hardware minimum requirements: • PC according DIN EN 60950 • USB 2.0 port (3.0 possible) Software requirements: • Microsoft Windows Version 7,8,10 • RIDA qLine® Soft 3 Start up 3.1 Introduction This chapter describes how to install and start this device. This includes unpacking, accessories, the software installation and PC connections.
  • Page 11: Unpacking And Positioning Of The Device

    Accessories required but not provided with the instrument: Product Art. No. RIDA qLine® Soft Z9995 RIDA qLine® Incubation Set ZG2701 Product Art. No. RIDA qLine® QC-Kit ZG1108 (for RIDA qLine® Soft) RIDA qLine® Allergy A6442, A6242, A6342, A6142, A6142EC2, A6142VIET, A6142PSMI, A6442UA1, A6242H, A6242PA, A6342UY, A6142UZ, A6442TZA, A6342MENA, A6442UZ, A6442BY, A6342KE, A6342BY, A6142HVEN, A6142UY, A6442UA2,...
  • Page 12: Environmental Conditions

    RIDA qLine® Scan | User Manual 3.4 Environmental conditions Place the instrument on a flat, horizontal surface with sufficient amount of space around it. Avoid setting up at places where it can fall down. Warning: Please, pay attention that the pulled out drawer doesn’t reach out over the working place.
  • Page 13: Transport And Storage Conditions

    3.6 Transport and storage conditions Transport Environmental temperature: -40 °C to 65 °C Relative humidity: 0 % to 95 % Storage Environmental temperature: -20 °C to 30 °C Relative humidity: 20 % to 30 % It is recommended to choose the transport and storage conditions in the medium range of the conditions specified above.
  • Page 14: Connection Of Rida Qline® Scan

    RIDA qLine® Scan | User Manual 4 Installation and connection of RIDA qLine® Scan 4.1 Transportation lock The device is locked for transportation. Please read the note attached to the device attentively. Turn the device upside down and proceed upon instruction. Caution: Before turning on the instrument, remove transportation lock.
  • Page 15: Preparation

    4.2 Preparation Please plug the supplied cables into the respective sockets at the rear of the scanner. 4.2.1 Connection The RIDA qLine® Scan features two sockets at the rear. 1. Power Plug 2. USB Port Connect the black power plug with socket at the rear of the scanner. Use only the external power adapter provided with the instrument.
  • Page 16: Installation

    Note: If an older version was previously installed you must execute the program „SetRIDAqLineScanner.exe“. This program is stored in the folder „C:\Program Files (x86)\R-Biopharm\qLine“ Note: Please keep the manual of the RIDA qLine® Soft software at hand to support you working correctly with the reader.
  • Page 17: Qc Test Using Rida Qline® Soft

    5 QC test using RIDA qLine® Soft In order to check the perfect function of the RIDA qLine® Soft it is recommended to use the RIDA qLine® QC kit (ZG1108). Start the RIDA qLine® Soft software on the connected PC. To perform the QC test, click the down arrow in Settings Perform QC test.
  • Page 18: Image Creation With Rida Qline® Scan

    You can either print it, save it as a PDF, or simply close the preview. All reports are automatically saved as PDF in this directory: C:\R-Biopharm\Database\qLine\QCArchive. This report consists of a total of either 11 or 21 pages: the first page of the report shows you an overview of the QC measurement, and subsequent pages show the results for each individual strip.
  • Page 19: Erroneous Image Acquisition

    7 Erroneous image acquisition If any image does not reflect the visual perception, please check the correct proceeding upon the instructions and restart the image acquisition again. If you are not able to receive a correct image please contact the manufacturer. Warning: After scanning please check, if the membranes were evaluated with good quality.
  • Page 20: Cleaning And Maintanance

    RIDA qLine® Scan | User Manual 9 Cleaning and maintanance Optimal results will be obtained when the device is operated virtually dust-free. Clean the drawer and the insert from time to time, depending on the level of contamination 9.1 Outside Clean the device only with water and a mild detergent.
  • Page 21: Cleaning Of The Glass Sheet

    9.3 Cleaning of the glass sheet Before cleaning, take out the pad and the drawer completely. Warning: Always ensure the disconnection of the device from the power grid by unplugging the reader. To clean the RIDA qLine® Scan intensively, please unplug the device and pull the drawer out.
  • Page 22: Disposal

    RIDA qLine® Scan | User Manual 10 Disposal All reagents and materials must be disposed of properly and responsibly after use. Instruments must be disposed of properly and responsibly at the end of their life cycle. Please observe the applicable national regulations for disposal.
  • Page 23: Corrective Action/Notification To Authorities

    11 Corrective action/Notification to authorities For users in the European Union: Serious incidents occurring in the context of the product must be reported to R-Biopharm AG and the responsible national authority. 12 Conformity IEC 61326-2-6 and RoHS3 The CE marking of the RIDA qLine® Scan confirms that the RIDA qLine® Scan is compliant with Regulation (EU) 2017/746 („In Vitro Diagnostic Medical Devices“).
  • Page 24 RIDA qLine® Scan | User Manual R-Biopharm • An der neuen Bergstraße 17, 64297 Darmstadt, Germany E-mail: orders@r-biopharm.de • clinical.r-biopharm.com...

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