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Diesse AUTO-DAT User Manual

Semi-automatic instrument for agglutination testing
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USER MANUAL
Rev. 1.2 – September 2024
Semi-automatic instrument for agglutination testing
SOFTWARE VERSION 1.02.00
AUTO-DAT (REF. 26001)
ONLY FOR IN VITRO DIAGNOSTIC USE

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Summary of Contents for Diesse AUTO-DAT

  • Page 1 USER MANUAL Rev. 1.2 – September 2024 Semi-automatic instrument for agglutination testing SOFTWARE VERSION 1.02.00 AUTO-DAT (REF. 26001) ONLY FOR IN VITRO DIAGNOSTIC USE...
  • Page 2 This page is intentionally left blank. Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 3: Thermal Paper

    AUTO-DAT models: This manual applies to the following models of AUTO-DAT. Catalogue number Description 26001 AUTO-DAT Accessories: Catalogue number Description 10403 THERMAL PAPER List of manual revisions Manual revision Description of changes First issue New software version v 1.01.00 New software version v 1.02.00...

  • Page 4: Technical Assistance

    Member State. No part of this manual may be reproduced in any form or by any means, electronic, mechanical or otherwise, for any use whatsoever without the prior written permission of DIESSE Diagnostica Senese S.p.A. Rev. 1.2 AUTO-DAT...
  • Page 5 Directive 2012/19/EC Attention: please read this manual carefully and comply with the safety symbols Warning: risk of electric shock BIOHAZARD: risk of contamination handling potentially infected substances Risk of hand crushed due to mechanical movements AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 6 In case of sale or transfer, make sure that this manual accompanies the AUTO-DAT to allow new users to be informed about the instrument’s operation and the related warnings.
  • Page 7 The screenshots in this manual are for illustration purposes only. DIESSE is not liable for damages caused directly or indirectly by errors, faults or incidents, due to the use of manuals that do not correspond to the version of the instrument provided.
  • Page 8 BIO-CONTAMINATION HAZARDS Potentially infected material is handled. When an analysis system like the AUTO-DAT is used, all precautions must be taken regarding biological risks. The samples must be disposed of in accordance with laboratory instructions and with local laws. Observe personal and group safety measures required for the operator and appropriate for the work environment.

  • Page 9: Table Of Contents

    Uninstallation and Reinstallation ............................. 31 2.7.1 Positioning in the same building or room ........................31 2.7.2 Placement in a different location ............................31 2.7.3 Uninstalling the instrument ..............................31 Replacements ....................................32 2.8.1 Printer paper replacement procedure.......................... 32 AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 10 Personalized Header ................................76 6.3.5 Temperature scale ..................................77 6.3.6 Printer ........................................78 6.3.7 Software update ....................................78 Diagnostics ..................................... 79 User management .................................. 80 6.5.1 User list ........................................81 6.5.2 Add user ........................................81 TROUBLESHOOTING ..................................83 Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 11: Introduction

    This instrument is intended to be used only by professional laboratory users. It is prohibited to use AUTO-DAT for any activity unrelated to its intended use. 1.2 GENERAL INFORMATIONS Before using the instrument, you should carefully read and carefully follow all the safety features emphasized in Section 2.1...

  • Page 12: Description Of The Instrument

    3. Acquisition of images through two cameras. 4. Interpretation of the images. With AUTO-DAT, only one microplate can be processed at a time, and the duration of a work session varies according to the type of test to be performed.

  • Page 13: Front View

    Figure 2: Front view Front View Legend: Front door RGB Led Strip   Instrument control unit with Touch Internal Printer   Screen display 1.4.2 Rear view AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 14: Open Front View

    1.4.3 Open Front View By opening the front door, access is granted to the instrument's interior 4), which IGURE houses the microplate holder. The user is required to insert the microplate into its holder to conduct the tests. Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 15: Technical Components

    1.4.4 Technical components The technical components of the instrument are as follows: TOUCH SCREEN DISPLAY • The 10'' touch screen enables control and operation of the instrument through a graphical interface. Figure 5: Touch screen display AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 16 CAMERAS • The AUTO-DAT instrument is equipped with a pair of color cameras, which meet the UVC standard, with 12 MP resolution and 25mm focal length optics. The two cameras are positioned above the microplate in such a way that each camera has the task of taking a picture relative to half of the microplate.
  • Page 17 • LIGHTING BOARD The AUTO-DAT instrument is equipped with a LED lighting board, located below the microplate holder, which is used to backlight the microplate analysis wells during analysis cycles. Under each individual well of the microplate there is a single LED To guarantee an homogeneous illumination.
  • Page 18 • FRONT DOOR LOCK The AUTO-DAT instrument is equipped with a door lock mechanism that remains activated throughout the analysis to prevent the user from inadvertently opening the door and coming into contact with any moving parts or altering the lighting conditions for photo capture.
  • Page 19 Figure 11: Front door lock • BARCODE READER The AUTO-DAT instrument is externally equipped with an external barcode reader for sample and reagent barcode identification. The handheld barcode reader is the model ZEBEX Z-3220 Plus with USB cable. Figure 12: Barcode reader LED RGB •...

  • Page 20: Technical Data

    1.5 TECHNICAL DATA Figure 13: Dimensions Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 21 Printer line, speed 20 mm/sec. Image processor See Central Unit Interfaces 1 x RS232C, 2 Host USB, Ethernet Protection category CLASS II Safety standard EN 61010-1, EN 61010-2-101 EN61326-1, EN61326-2-6 Installation category Protection Class IP20 AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 22: Tests

    1.6.1 Titration curves The titration curves for the various tests that can be performed on AUTO-DAT are stored in the instrument. For interpretation of the result obtained (agglutination titers), follow what is given in the Instructions For Use of the kits applied to the machine.

  • Page 23: Types Of Compatible Microplates

    The AUTO-DAT MICROPLATES TPHA (code 26004) are used for Syphilis tests (TPHA-DAT ADVANCED). The use of any other type of microplate is prohibited on the AUTO-DAT instrument. DIESSE Diagnostica Senese S.p.A. accepts no responsibility for use in connection with devices other than those indicated in this section.

  • Page 24: Instrument Label

    Union 1.9 DISPOSAL The AUTO-DAT instrument relies on the use of an electrical power source and therefore, in compliance with the EUROPEAN DIRECTIVE 2012/19/CE of July 04, 2012 and later amendments by the European Parliament, it is classified as Electrical-Electronic Equipment.

  • Page 25: Transport, Installation And Warnings

    DIESSE DIAGNOSTICA SENESE S.p.A. Any materials and/or accessories supplied for AUTO-DAT have been specially designed and cannot be replaced with other types of materials or supplies. The instrument's performance can be severely compromised when using other types of materials and/or accessories.

  • Page 26: Electrical Hazards

    2.1.5 Electrical hazards The instrument must be powered only by the power supplies given by Diesse Diagnostica Senese S.p.A. and contained in the packaging, and these power supplies must be connected to an electrical outlet. The power supply must meet the requirements indicated on the label.

  • Page 27: Preparation And Checks Before Installation

    Any damage suffered by the instrument during transport or missing parts or elements must be reported immediately to Diesse Diagnostica Senese SpA. Keep the original packaging for any future technical service needs. The box must not be rotated during transport. The instrument can be transported in temperature conditions between 5 and 45°C.
  • Page 28 TRANSPORT AND INSTALLATION must be carried out by personnel authorized by Diesse Diagnostica Senese S.p.A. as stated in the Installation Report. Refer to the Installation Guide DECOMMISSIONING and SHIPPING must be carried out by a technician authorized by DIESSE Diagnostica Senese S.p.A.

  • Page 29: Positioning

    (doors, windows, etc.) so that it is not subjected to random impacts during operation. AUTO-DAT complies with the directives regarding electromagnetic emissions, however it is advisable, where possible, to position the instrument away from devices that generate electromagnetic waves (e.g. laboratory refrigerators, centrifuges) and instruments that do not have the CE marking, as these could occasionally interfere with the instrument’s operation.

  • Page 30: Unpacking

    2.5 UNPACKING The AUTO-DAT is a precision instrument and must be handled as such. Inappropriate operations may damage the internal components and cause mechanical damage. Follow the instructions in this section in order to ensure the safety of the instrument and of the operator.

  • Page 31: Installation

    5. Optional - Before switching on the instrument, connect the external barcode reader (accessory). 6. Turn on the instrument by switching the power switch, located on the rear side of the instrument. 7. Wait for the instrument to start the initial automatic control procedure. AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 32: Uninstallation And Reinstallation

    This section of the user manual is described in more detail in the "AUTO-DAT Installation Guide," included in the box in which the instrument arrives at its destination. It is, therefore, necessary that it be read with particular care. The operations described should be carried out by personnel authorized and appropriately trained by DIESSE Diagnostica Senese SpA.

  • Page 33: Replacements

    Once the above check has been carried out, replace the paper roll as described below: Open the front door of AUTO-DAT to access the printer 2. Raise the printer assembly block upwards until it locks in place 3. Open the door of the printer assembly 4.

  • Page 34: Limitations And Warnings

    Potentially infected material is handled. When using an analysis system such as AUTO-DAT, all precautions regarding biohazard must be taken. The samples must be disposed of in accordance with laboratory instructions and with local laws.

  • Page 35: Instrument Preparation

    Once AUTO-DAT has been properly installed, turn on the instrument by switching the power switch, located on the rear side of the instrument. AUTO-DAT is equipped with a touch screen, on which, when the instrument is turned on, the graphical interface appears from which to program the work session. Any operation performed by the user can be done on the touch screen.

  • Page 36: Maintenance

    Cleaning and sanitization of the internal parts of the instrument All operations must be carried out only by authorized DIESSE Diagnostica Senese S.p.A. personnel and must be done with the instrument turned off and completely open in all its parts.

  • Page 37: Scheduled Maintenance

    After turning on the instrument, a loading screen is displayed and during this time the instrument performs internal checks on the various components. When the check session finishes successfully, the first page displayed is the user authentication page. Figure 18: Login page AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 38: Main Menu

    Using the buttons and functions IGURE displayed, it is possible to: Start the analysis; • Access the settings menu; • Access the instrument data archives; • Access the help/quick start guide; • Log out of the active account. • Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 39: Command Description - Common Information

    Section 4.1. Archive button: allows access to the archive of the instrument. Pressing the "Archive" button, AUTO-DAT displays the database with all sessions run by the instrument. For a detailed explanation of the Archive, refer to Section of this manual.

  • Page 40: Guided Reading Of The Results Printout

    18). IGURE System information: provides access to the instrument's on-board startup guide in which the key points of AUTO-DAT use are summarized 21). IGURE The quick guide changes language based on the language set in the graphical interface of the instrument.
  • Page 41 6.3.4) this will appear below the instrument serial number line. The receipt is printed in the language set in the configurations of the instrument. Figure 22: Printed receipt ***************************************************** DIESSE Diagnostica senese S.p.a AUTO-DAT SW v1.02.00 RESULTS ***************************************************** S/N 110...

  • Page 42: Description Of An Analytical Cycle

    4 DESCRIPTION OF AN ANALYTICAL CYCLE AUTO-DAT is a semiautomatic instrument designed to facilitate the operator in the execution, interpretation and reporting of microplate agglutination serological tests. This section will describe in detail the use of all the features of the instrument to run an analysis cycle.
  • Page 43 In case you realize you made an entry error, you can press this button to delete the selected barcode from the sample list. The barcode of the samples has a maximum fixed length of 15 alphanumeric characters, except for barcodes of control samples, as specified in Section 4.5. AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 44 In order to continue with the programming, at least one sample code must be inserted. If not, a pop-up will display, as seen in 28, that will warn the user to add at least IGURE one sample to continue. Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 45 QC type and the chosen test. If there is a mismatch, the instrument displays a pop-up, as shown in 30, alerting the user to the inconsistency and IGURE preventing the cycle from proceeding until the correct test for the inserted QC type is selected. AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 46 If the RPR-DAT test is selected, a pop-up will appear on the screen, as shown in IGURE 32, prompting the user to choose whether to perform the test in qualitative mode or semi-quantitative mode. Figure 32: RPR-DAT mode Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 47 34, in this case, the reagents AO, BO, and TO have been selected. IGURE Based on the number of reagents selected, the instrument will suggest a plate layout to optimize space on the microplate. AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 48 In the lot field, in case of manual input, only enter the first three digits of the lot number printed on the kit; this is easily remembered by the instrument as the lot field is limited to a maximum of three digits. Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 49 "EXPIRED" next to the lot number. In the session archive page, the traceability of the expired kit usage is indicated by the term "EXP" positioned next to the lot number, located in the header of the page, at the top right corner. AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 50 IGURE The composition of the microplate is done automatically in order to minimize the waste of materials. Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 51 In case the samples entered in the analysis list fail to be placed all within the microplate proposal, those in excess will be kept in memory for the next cycle, after warning the user via pop-up. AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 52 • 41; the overview will IGURE consist of a schematic table showing for each well what type of sample and reagent is to be placed inside it Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 53 43, which features a 90° rotation of the plate visualization. This IGURE rotation serves to remind the user to insert the plate in the correct orientation into the instrument after the samples and reagents have been dispensed. AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 54: Sample Preparation

    4.3 MICROPLATE LOADING After preparing the microplate correctly, the user inserts it into the instrument, proceeding as follows: Open the front door of AUTO-DAT. 2. Insert the microplate slightly tilted toward the innermost part of the machine (see 44). IGURE 3.
  • Page 55 (marked with B). In Figure 40 we can see the microplate correctly inserted. Figure 45: Check completed insertion shows the direction for proper insertion of the microplate into AUTO-DAT so IGURE that images are processed accurately: the letter row should face the operator and the number column to his left.

  • Page 56: Run

    Progress status of the session via a progress bar Timing for the end of the session • • STOP button to stop the session First photos of the microplate as soon as they are taken • Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 57 50. Following this error, you will be taken directly to the results page, IGURE where you can view the session images. The results for samples that could not be calculated are displayed as ERR5. Figure 50: Analysis error AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 58 TPHA-DAT and semi-quantitative RPR-DAT. 52, you can see the results review page, in the case where the sample consists IGURE of a single well. On this page, you can view the following information from top to bottom: Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 59 Using the up/down arrows, you can navigate within the sample and view the wells associated with that sample. Using the left/right arrows, you can change the view of the sample. AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 60 "!". In the RPR-DAT ADVANCED test using semi-quantitative method, if a clear error attributable to information extraction by the calculation algorithm is present in the Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 61 The displayed photos also feature red rectangles that assist the user in identifying which portion of the image relates to a specific sample. Additionally, the coordinates for each analysis well are displayed. AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 62 Pressing this button takes you to the archive section. Pressing this button displays a zoom of the photo related only to the specific sample, as can be seen in IGURE Figure 56: Sample image Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 63 Figure 58: Positive QC error Figure 59: Negative QC error The results of positive QCs, besides being in the sessions where they were analyzed, can also be found in the dedicated QC section exclusively for them. AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 64: Host

    In case none of the inserted samples need analysis, a pop-up as shown in will IGURE appear on the screen. Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 65: Coloured Front Bar

    Yellow: during programming and execution of the analysis cycle • Green: after the cycle finishes until reaching the results page • • Light blue: during the remaining use of the instrument (results, settings, and home) AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 66: Archive

    Additionally, by clicking on the date, a window opens, as shown in 63, where you can quickly select the IGURE archiving date by adjusting the specific fields for day, month, and year. Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 67 Import button. The instrument will load the database from the drive into the system. If no USB drive is inserted, a pop-up will appear on the screen, notifying the user that no USB drive was found for importing or exporting the database. Figure 65: Import/export AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 68 Once the search criteria are entered, simply press the Filter button. The instrument will conduct a search within the database to display only the sessions that meet the set search criteria, as shown in Figure 68. Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 69 QC archive section. The IGURE window that opens, as seen in 69, enables the selection of which test to IGURE view for the QC executed on the instrument up to that moment. AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 70 QC lots executed on the instrument for that specific test. By selecting a lot, it's also possible to view the list of all positive QCs performed on the instrument along with their respective calculated values. Figure 70: QC lot Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 71: Session Item

    Pressing this button allows you to manually send the session in the archive to the Host. Pressing this button opens a text page where you can add notes. If a note was already entered at the end of the session, pressing this button allows you to view AUTO-DAT USER MANUAL Rev. 1.2...
  • Page 72 Pressing this button allows you to export the raw session data to a USB drive inserted into the instrument. The exported files include the session images and an Excel file containing the raw data generated by the instrument during result generation and calculation. Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 73: Settings

    This manual will only cover topics related to the installation and customization of the instrument's configuration. For all other topics that do not pertain to this purpose such as functions of the "Technical Support" section, please refer to the Service manual. AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 74: Information

    The page that opens after choosing "General" is as shown in Figure 75. From here, you can view and access a variety of options, which will be described in detail in the following paragraphs. Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 75: Language

    The available language choices are as follows: • Italian English • Once you click on the desired language, the software will automatically load the translation of the interface strings in that specific language. AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 76: Localization

    By selecting the "Localization" option, as shown in Figure 77, a portion of the window opens, displaying two fields where you can enter any information related to the localization (Region/State) of the instrument's installation. Figure 77: Localization Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 77: Date/Time

    These personalized details will then be included in the header of every receipt printed by the instrument. This option is visible only if the user has admin credentials. AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 78: Temperature Scale

    By selecting the "Temperature Scale" option, as shown in Figure 80, a portion of the window opens, displaying two buttons related to the unit of measurement for the temperature measured by the instrument: Celsius or Fahrenheit. Figure 80: Temperature scale Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 79: Printer

    In case a user selects a file that is not an update file by mistake, the instrument will alert the user that the selected file is not valid for the update. AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 80: Diagnostics

    IGURE Motor • Camera • • Printer By selecting any of these three options, it will be possible to reset the motor, take a test image, and print a test receipt. Rev. 1.2 AUTO-DAT USER MANUAL...

  • Page 81: User Management

    On the settings page, only if you are an Administrator user you can access the "User Management" option, as shown in 84, which manages user access to the IGURE instrument, their permissions, and passwords. Figure 84: User management AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 82: User List

    IGURE Delete the user after pressing the button • Figure 85: User list 6.5.2 Add user By selecting the "Add user" option, you can create a new user from scratch, as shown in IGURE Rev. 1.2 AUTO-DAT USER MANUAL...
  • Page 83 Confirm password: A field necessary to verify the correct entry of the password. • Once these fields are filled out, you need to press the "Save" button to complete the user registration. If you want to cancel the input, you can simply press the "Clear" button. AUTO-DAT USER MANUAL Rev. 1.2...

  • Page 84: Troubleshooting

    Turn off the instrument and wait a few seconds; turn on the instrument again and restart the operating cycle as described (at the start of the analysis procedure the instrument resets all internal units). Rev. 1.2 AUTO-DAT USER MANUAL...

This manual is also suitable for:

26001

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