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R-Biopharm RIDA QUICK SCAN II User Manual

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Summary of Contents for R-Biopharm RIDA QUICK SCAN II

  • Page 1 RIDA QUICK SCAN II ® User manual https:/ /r-b.io/15...
  • Page 2 RIDA QUICK SCAN II Version 2.1 | User Manual ®...
  • Page 3 Item no. ZRQS2-KD: IVD Version Version 2.1 (2022-01-21) Valid for firmware version 44.04 and higher Copyright 2022 by R-Biopharm AG © All rights reserved. It may not be reproduced in whole or in part or be translated into another language without our express, prior written consent.

  • Page 4: Table Of Contents

    RIDA QUICK SCAN II Version 2.1 | User Manual ® Contents General information 8.2 Reading in lots and methods 26 Important information 8.3 Preparing and initiating a Explanation of symbols used measurement Intended use Cleaning and care Selection of installation site 7 Notes and annex Unpacking and Technical data, ambient...

  • Page 5: General Information

    General information Please carefully compare the contents of this delivery with the enclosed delivery note, the package leaflet or the invoice. We recommend that you keep a copy of this document together with the instructions, so that you can quickly access information about the date and scope of delivery in case of future queries, re-orders or service work.

  • Page 6: Explanation Of Symbols Used

    RIDA QUICK SCAN II Version 2.1 | User Manual ® Explanation of symbols used In these operating instructions, special information is highlighted by the use of symbols: Warning: Follow the instructions to prevent the risk of injury. Warning: Follow the instructions to prevent damaging the device.

  • Page 7: Selection Of Installation Site

    If there is any cause for complaint about the delivery, please immediately contact R-Biopharm, Darmstadt, or the supplier from which you obtained the RIDA®QUICK SCAN II. Warning: Only professional users may operate the RIDA®QUICK SCAN II.
  • Page 8 R-Biopharm. In these cases, any warranty claims against the manufacturer are null and void.

  • Page 9: Rida®Quick Scan Ii: Overview

    3 RIDA®QUICK SCAN II: Overview Housing Status LED Touchscreen display On switch Test cassette Drawer for test cassette Fig. 1: RIDA®QUICK SCAN II general overview 1 Supply voltage 3 USB port 2 Firmware Button (OPT) 4 Network Interface 5 PC Connection (USB) Fig.
  • Page 10 RIDA QUICK SCAN II Version 2.1 | User Manual ® 1 Control strips (ZRQS2-KS-KD) 2 Power supply (ZRQS2-NETZTEIL) Fig. 3: Scope of delivery...

  • Page 11: Operating The Rida®Quick Scan

    4 Operating the RIDA®QUICK SCAN II This section describes the essential operating steps, as well as the menus and submenus. Refer to section 8 for step-by-step instructions on performing measurements. General safety information: Some users may find it more convenient to operate the RIDA®QUICK SCAN II touchscreen using a stylus (“touch pen”).

  • Page 12: Switching Off

    ® Warning: If the status LED illuminates red, the charging circuit is defective. Please contact your local distributor or R-Biopharm, Darmstadt! General safety information: If the internal calibration fails, the procedure is aborted with an error message. The device starts up and displays the main menu, but activating a measurement causes a failed calibration message to appear.

  • Page 13: Main Menu

    4.3 Main menu Once the RIDA®QUICK SCAN II has started, the start screen with the main menu is displayed. Fig. 4: Overview main menu The header of the main menu shows the date and time, the number of measurements that have been saved and the number of measurements that are still possible. The date and time can be changed under “Setup”...

  • Page 14: Submenu "Setup

    QR code on the certificate (if existing). The method to be used is loaded automatically. The RIDA®QUICK SCAN II locks if the control measurement fails or the measurement is invalid. In this case, please contact your local distributor or R-Biopharm, Darmstadt. Fig. 6: Overview menu item “control measurement”...
  • Page 15 (“Files”). The RIDA®QUICK SCAN II will be locked if at least one item of the self-test fails. In this case, please contact your local distributor or R-Biopharm, Darmstadt. Device setup This function allows the setup of the date and time, user management, screen setup and language.

  • Page 16: Submenu "Management

    RIDA QUICK SCAN II Version 2.1 | User Manual ® 4.6 Submenu “Management” Fig. 7: Overview submenu “Management” Backup For backup methods and lots, measurements and users can be selected independently of each other. All of the files in the RIDA®QUICK SCAN II directory “measurements” are backed up in a directory with the same name and device serial number on a connected USB flash drive.

  • Page 17: Submenu "Measurement

    Fig. 8: Overview menu item “Backup” Lot/Method Selection of the import method: from barcode (with connected reader, see Section 5) or via USB (with USB stick plugged in). In the “Delete Lot / Method” subitem, individual lots or methods can be selected and deleted.
  • Page 18 RIDA QUICK SCAN II Version 2.1 | User Manual ® The RIDA®QUICK SCAN II then prompts you to insert a test cassette or to confirm that a test cassette has been inserted. Proceed as follows to insert a test cassette: • Lightly press in the ribbed surface on the front plate of the drawer until you hear the drawer unlock.
  • Page 19 Fig. 10: Correct orientation of the test cassette • Press the drawer closed until it engages with the housing. Fig. 11: Gently close the drawer General safety information: If the test cassette is inserted incorrectly, the measurement process will be aborted with an error message. If a measurement is started without a test cassette in the device, error message “Test cassette not inserted”...

  • Page 20: Submenu "Results

    RIDA QUICK SCAN II Version 2.1 | User Manual ® General safety information: To close the drawer again immediately after opening, you must first pull the drawer a little way out of the housing. Otherwise it cannot engage! The measurement now starts automatically. When the measurement is successful, the result is displayed directly on the screen.
  • Page 21 Moreover, it is possible to filter saved measurements for ID, date, method or lot (Fig. 13). Afterwards, these filtered measurements can be completely or by selection deleted or exported as a report and an overview report to a USB drive via “Options”. Selecting “PDF/ CSV reports”...

  • Page 22: Submenu "Standby

    RIDA QUICK SCAN II Version 2.1 | User Manual ® By tapping “create report” a printable result PDF is created and exported to a connected USB flash drive. The displayed “Validity” of the measurement is positive if no error message occurred during the measurement.

  • Page 23: Connecting External Components

    5 Connecting external components The USB port on the back of the RIDA®QUICK SCAN II is used to connect the barcode scanner for importing lot and method information and for exporting data via a USB stick. General safety information: Only readers specially approved for the RIDA®QUICK SCAN II can be used (see “Technical data”).

  • Page 24: Performing Firmware Updates

    RIDA QUICK SCAN II Version 2.1 | User Manual ® 6 Performing firmware updates Firmware updates must be performed if, for example, new software functions are available, or possible software faults are to be corrected. In this case use an USB flash drive containing all of the files necessary for the update.

  • Page 25: Lan Access To Rida®Quick Scan

    7 LAN access to RIDA®QUICK SCAN II To have access via LAN to all measurements, methods, and lots, it is possible to use an FTP program to access the RIDA®QUICK SCAN II. The RIDA®QUICK SCAN II and the PC must have a valid network connection, and they both must be in the same network. For reasons of data security, LAN access should be allowed only for the duration of data transmission, and the device should be disconnected from the network directly afterward.

  • Page 26: Performing A Measurement

    RIDA QUICK SCAN II Version 2.1 | User Manual ® 8 Performing a measurement This section describes the typical procedure for performing a measurement. The procedure can roughly be divided into three steps 8.1 Creating/selecting a user If the RIDA®QUICK SCAN II is switched on in its brand-new state, a user can be created first.

  • Page 27: Preparing And Initiating A Measurement

    Fig. 18: Overview menu item “Lot / Method” General safety information: If the reading procedure is initiated without the appropriate reader being connected to the RIDA®QUICK SCAN II or the wrong option was selected, the process will be stopped after a few seconds, and the message “No reader available”...
  • Page 28 Users do not have the option of performing service work themselves on RIDA®QUICK SCAN II parts. If the error message appears again after the measurement is repeated, note the error message displayed and contact your local distributor or R-Biopharm, Darmstadt. Printing and exporting the measurement result After a backup, as described in section 4.8, the PDF result files generated are located in the...

  • Page 29: Cleaning And Care

    9 Cleaning and care You can use a soft cloth moistened with water or alcohol to clean the housing of the RIDA®QUICK SCAN II and the interior of the drawer. Normal agents for wipe disinfection, e.g. 70 % isopropyl alcohol or ethanol, can also be used on all accessible surfaces. Performing the self-test and control measurement allows for a routine function test of the RIDA®QUICK SCAN II.

  • Page 30: Notes And Annex

    RIDA QUICK SCAN II Version 2.1 | User Manual ® Notes and annex Technical data, ambient conditions Mains voltage: 100 … 240 V AC, 50 … 60 Hz Mains unit output voltage/current 6 V DC/3.6 A (max.) Polarity of housing plug connector: Battery: Nominal voltage 3.6 V Nominal capacity 8700 mAh Device safety: IEC 1010-1/EN61010-1/VDE 0411, protection class 3 Temperature range:...

  • Page 31: Ec Declaration Of Conformity/Ce Mark

    R-Biopharm shall not assume any liability for damage to the device or accessories or other property damage or personal injury resulting from failure to observe the safety information. In such cases, all warranty claims against R-Biopharm are null and void.

  • Page 32: Disposal Information

    RIDA QUICK SCAN II Version 2.1 | User Manual ® We also recommend having the electromagnetic environment assessed before the RIDA®QUICK SCAN II is put into operation. When these measures are observed, the device does not pose any risk. Warning: Do not use the RIDA®QUICK SCAN II in the vicinity of sources of strong electromagnetic radiation as they can interfere with proper functioning.

  • Page 33: Annex 1: Error Messages And Warnings

    Annex 1: Error messages and warnings Possible error messages are listed below: (#03.00.1) Calibration error (#03.01.0) Re-calibration error (#03.02.1) Device not calibrated, wrong camera parameter or control measurement failed (#03.03.0) Reference area error (#04.00.1) Corrupt image (#17.08.1) Corrupt image (#04.01.0) Camera out of focus (#04.02.0) Unable to open configuration file...
  • Page 34 2) This error occurs if a measurement is performed after calibration fails. If any of these errors occur, a restart and a repeat measurement can be attempted. If the error recurs, please contact your local distributor or R-Biopharm, Darmstadt. Report all serious adverse events associated with the RIDA®QUICK SCAN II to...
  • Page 35 Possible warnings are as follows: (#07.00.1) Could not find directory (#07.02.1) Could not create directory (#07.01.1) No storage device found (#07.06.1) Failed to copy data (#07.07.1) Failed to copy data. No source folder (#07.08.1) Failed to copy data. Source folder is empty (#07.09.1) Failed to delete data (#09.00.1)

  • Page 36: Annex 2: Version History

    RIDA QUICK SCAN II Version 2.1 | User Manual ® Annex 2: Version history Version number Section and designation Version 2.0 (2020-05-25) Previous version Version 2.1 (2022-01-21) Explanation of symbols used: Attention. Potential electrical shock Intended use Unpacking and installation: operating instructions RIDA®QUICK SCAN II: Overview: Components in the delivery without accessories 4.5 Submenu “Setup”: Traceability...
  • Page 38 RIDA QUICK SCAN II Version 2.1 | User Manual ®...
  • Page 40 RIDA QUICK SCAN II Version 2.1 | 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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