Abbott DIGIVAL LFR-024 User Manual
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Abbott DIGIVAL LFR-024 User Manual

Abbott DIGIVAL LFR-024 User Manual

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DIGIVAL
™
USER MANUAL
LFR-024

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Summary of Contents for Abbott DIGIVAL LFR-024

  • Page 1 DIGIVAL ™ USER MANUAL LFR-024...
  • Page 3 DIGIVAL User Manual ™ DIGIVAL User Manual...
  • Page 4 Home Screen Menus Home Read Read QC Calibration Test Settings Preferences Logout Test Test Check History (admin only) Patient Date and Synchronize Tests Time Access QC Tests Language Control Calibration Test Sound Checks Settings Delete All Test Screen Connectivity History (admin only) Export All Test...
  • Page 5 Settings Menu (Admin users only) Settings Test Date and Access Connectivity Administration Settings Time Control Additional Software Date Login Network elds Update Auto Factory Time Operators Middleware Print Reset Auto Auto Upload Log Out Schedule Export Results Admin Assays Sync Password Walk Purge...

  • Page 7: Table Of Contents

    Contents Introduction .................. 5 Intended Use ....................5 Product Description ................... 5 Warnings and Safe Use ..............6 DIGIVAL at a Glance ..............8 ™ 4 Getting Started - Setup ..............9 Unpacking and inspection ..............9 4.2 Installation and operating conditions ..........9 4.3 Power up and first time login ..............11 DIGIVAL Touchscreen ..............13...
  • Page 8 Connectivity ....................31 7.4.1 Network Interface Settings ..............31 7.4.1.1 Network Interface Settings - Method ............. 32 7.4.1.2 Network Interface Settings - Other Properties ........32 7.4.2 Middleware Settings .................. 33 7.4.3 Auto Upload Results .................. 33 7.4.4 Sync Settings ....................34 7.4.5 Purge Test Results ..................
  • Page 9 E.9 Test Device Expired ..................55 E.10 Tray Barcode Read Failure ................55 E.11 QC Test Required ..................55 E.12 Incorrect Tray ....................56 E.13 Patient ID Invalid ................... 56 E.14 Test Device QR Code Read Failure ............56 E.15 Test Device ID Mismatch ................56 E.16 Test Device Present ..................
  • Page 10 17 Symbols ..................64 18 DIGIVAL Specifications ............66 ™ 18.1 DIGIVAL ....................66 ™ 18.2 Power Supply .................... 67 19 Warranty (EN) ................68 20 Ordering and Contact Information ...........70 20.1 Reorder numbers ................70 20.2 Abbott Contact Information .............70 DIGIVAL User Manual...

  • Page 11: Introduction

    Abbott rapid assays. It is intended for professional and laboratory use only. This document describes the setup, configuration and operation of the DIGIVAL for the qualitative detection of selected Abbott Rapid Tests. Please refer to each specific package insert for details on running the individual tests.

  • Page 12: Warnings And Safe Use

    DIGIVAL off its work bench. The mains socket outlet intended for use with DIGIVAL power supply should be located near the DIGIVAL and be readily accessible. Abbott recommends that cables are disconnected when not in use for an extended period.
  • Page 13 Caution: Do not immerse in water or cleaning solutions. Caution: Clean only with indicated solutions. Caution: Patient ID and Test Type cannot be edited once testing has begun. Caution: Do NOT open the DIGIVAL drawer during testing. The test is not saved until the completed result is displayed.

  • Page 14: Digival ™ At A Glance

    DIGIVAL at a Glance ™ DIGIVAL , Front View ™ Power On/Off Button Test Insert Tray DIGIVAL , Back View ™ Barcode scanner bracket location holes USB port (x1) Power connection Ethernet USB ports (x2) DIGIVAL User Manual...

  • Page 15: Getting Started - Setup

    Carefully open packages containing the DIGIVAL and barcode scanner. Inspect the shipping boxes, DIGIVAL and barcode scanner for signs of damage. If any equipment is damaged, notify Abbott immediately. Check to make sure that the following components are included in the...
  • Page 16 Place the DIGIVAL on a clean, flat, level and stable surface within reach of an electrical outlet. Avoid placing the DIGIVAL in direct sunlight. Allow sufficient space to open and close the drawer and to connect the accessories to the connection ports which are located at the back of the DIGIVAL.

  • Page 17: Power Up And First Time Login

    4.3 Power up and first time login Power Up: With the power connected, press the Power Button on the front of the DIGIVAL to power up and start the DIGIVAL. The power button lights up, and the Scan or Enter Operator ID screen displays.
  • Page 18 2. Set the date and time To set the date and time, tap: Settings>Set date and time See Section 7.1, "Date and Time" for more detail. 3. Set the Admin password To set the Admin password, tap: Settings>Access Control>Admin password Enter the new Admin password.

  • Page 19: Digival ™ Touchscreen

    DIGIVAL Touchscreen ™ Information can be entered into the DIGIVAL by tapping the appropriate touchscreen keys, or by using the barcode scanner. 5.1 Home Screen Figure 2: Home Screen Home Screen: Displays buttons for access to: Read a Test – See Section 9, “Reading a Test” •...

  • Page 20: Barcode Scanner/Onscreen Keyboard

    5.3 Barcode Scanner/Onscreen Keyboard Two onscreen keyboards (QWERTY and Numeric) are used to enter specific information into the DIGIVAL. Use the ?123 or Abc keys to switch between the alphanumeric and numeric keypads. Information can be entered by tapping the keypad keys or by scanning with the barcode scanner. Read Test Scan or Enter Test Device ID Step 1 of 9...

  • Page 21: Digival ™ Calibration

    DIGIVAL Calibration ™ Home>Calibration Check A calibration check verifies that the DIGIVAL’s internal camera is functioning correctly, with a lens free from debris, and that the DIGIVAL is working to specification. To ensure proper function, a calibration check of the DIGIVAL must be performed regularly;...
  • Page 22 Close the drawer. The DIGIVAL automatically starts the calibration check. Do not open the drawer. When the calibration check is complete, the result is displayed for review. If Calibration Check passes, • tap OK to proceed to the next step. If it fails, the card can be •...

  • Page 23: Settings Menu (Admin Access Only)

    Settings Menu (Admin Access Only) Home>Settings (Admin Access Only) The Settings menu is used to configure the DIGIVAL. It is only available when the Admin is logged on. Settings are saved even when the power is off. Settings include: Date and Time •...

  • Page 24: Access Control

    The Time screen displays: Tap to select either a 12 hour or 24 hour display. Set the correct time using the up and down arrow keys. Tap OK to advance. 7.2 Access Control Home>Settings>Access Control Use the Access Control menu to determine who can access the system and which functions they can perform.

  • Page 25: Operators (Admin Access Only)

    Operator ID and Password: If a password is required, tap Operator ID and Password and tap OK. If the system is changed from Operator ID Only to Operator ID & Password, Operator passwords will need to be assigned individually by the Admin before Operators can login.

  • Page 26: To Delete Operators, Or To Change Their Password

    If you have set Operator ID & Password to require passwords in the Login menu, the DIGIVAL prompts the Operator for a password. See 7.2.2, “Operators.” Only the Admin can change an Operator's password. Passwords are case-sensitive and must have 4-20 characters. Note: Use the ?123 or Abc keys to switch between the alphanumeric and numeric keypads.
  • Page 27 Deleting an Operator: You can delete one or all operators, Settings - Delete Operator but you cannot delete Admin. Operator List Operator 1 Deleting an Operator is permanent. Operator 2 Once deleted, the Operator profile Operator 3 will be lost. Test results already Operator 4 Operator 5 stored in the DIGIVAL performed...
  • Page 28 Screen will indicate successful Settings - Export All Operators Export and will prompt removal Export Successful Operators exported successfully. of USB memory stick. USB Stick can now be removed. Importing an Operator List: From Home>Settings>Access Control>Operators, tap Actions. Tap Import All. A Warning will display: "Importing an Operator List will delete all existing operators...

  • Page 29: Auto Log Out (Admin Access Only)

    Passwords are case-sensitive and must have 4-20 characters. Use the ?123 or Abc keys to switch between the alphanumeric and numeric keypads. Tap OK. Re-enter the password and tap OK. Note: If you forget the Admin password, you will need to contact Abbott Technical Support for assistance. DIGIVAL User Manual...

  • Page 30: Test Settings

    7.3 Test Settings Home>Settings>Test Settings Use the Test Settings menu to select Settings - Test Settings the desired Test option. Select Option Additional Fields For additional Test Setting options, Auto Print including Lot Management, tap the QC Schedule down arrow on the bottom right of Assays screen.

  • Page 31: Auto Print

    Home>Settings>Test Settings>Additional Fields > Read QC Test: Entry of QC lot numbers may be enabled or disabled. If enabled, the DIGIVAL will prompt the user for the QC lot number when running a QC test. Tap OK to save the new setting.
  • Page 32 In Warn and Lockout modes, the DIGIVAL checks the assay Threshold each time a patient test is run. If the threshold has been reached: In Warn mode, the DIGIVAL displays a warning that QC tests should be • run. The user may acknowledge the warning and proceed with the patient test.

  • Page 33: Assays

    7.3.4 Assays Home>Settings>Test Settings>Assays Use the Assays menu option to configure new assays on the DIGIVAL, as they become available. 1. Tap Add Assay 2. Scan the 2D barcode provided with the new assay kit. 3. The instrument will reboot itself to complete the new assay configuration.

  • Page 34: Lot Management

    1. Tap Walk Away Mode from the Settings - DIGIVAL Assay 1 Test Settings menu. Select Option Always Read Now 2. Tap the assay to configure. Always Walk Away Mode 3. Select the read type: Always Read Now: All tests on the DIGIVAL will read a test Back immediately after inserting a test...
  • Page 35 The import/export features may be used to transfer information about successful QC from one instrument to another. Tap Actions for the Import All Lots Settings - Lot Management and Export All Lots options. Use Select Options Export All Lots on the DIGIVAL Lot QC O on which successful QC has been Lot QC On...

  • Page 36: Blacklist

    7.3.7 Blacklist Home>Settings>Test Settings>Lot Management>Blacklist The lot blacklist feature provides an administrator the ability to block the usage of specific lots of test devices. This feature overrides all other settings on the instrument and is intended to prevent testing with a problematic lot or lots. Tap Blacklist in lower left screen.

  • Page 37: Connectivity

    Tap OK to confirm and remove the lot from the blacklist. Tap OK to continue. To add a lot to the blacklist, tap Actions then Add using touchscreen. Scan the barcode or enter manually using the touchscreen keypad. Tap OK to continue. 7.4 Connectivity Home>Settings>Connectivity Use the Connectivity menu to...

  • Page 38: Network Interface Settings - Method

    The following screen is displayed: To configure the Ethernet interface, first select the appropriate Method (DHCP or Manual). The DHCP method causes the DIGIVAL to obtain its network configuration from a DHCP server on the network. This is the simpler of the two methods and is the recommended option if a DHCP server is available.

  • Page 39: Middleware Settings

    7.4.2 Middleware Settings Home>Settings>Connectivity>Middleware Use the Middleware menu to configure the DIGIVAL to connect to a middleware system designed for use with the DIGIVAL. Your network administrator or middleware vendor should provide you with the necessary configuration values. To edit the Host setting, tap the Host line and the Edit Property screen appears.

  • Page 40: Sync Settings

    Uploading results to a middleware system requires that the network interface and middleware settings be configured properly as described in sections 7.4.1 and 7.4.2. To change the Auto Upload Results setting, tap the desired option then tap OK to save the new setting and return to the Connectivity Settings menu. 7.4.4 Sync Settings Home>Settings>Connectivity>Sync Use the Sync menu option to enable...

  • Page 41: Positive Patient Id

    7.4.6 Positive Patient ID Home>Settings>Connectivity>Positive Patient ID Use the Positive Patient ID menu option to enable a confirmation step in the Read Test workflow to verify the identity of the patient. Note that this feature requires a middleware system that supports patient queries. If this option is set to Warn or Lockout, the Read Test workflow is enhanced as follows: after the patient ID is entered or scanned, the DIGIVAL sends a request to the middleware system for the name and date of birth of the patient.

  • Page 42: Preferences Menu

    Preferences Menu Home>Preferences The Preferences menu includes: Synchronize Now: Allows • user to force an immediate synchronization with the middleware system. Language: Change screen text to • other language. Sound: Turn sound on or off. • Screen: Adjust brightness of •...

  • Page 43: Language

    8.2 Language Home>Preferences>Language To change the language of the screen text: Tap the button next to the desired language. Swipe to scroll for additional languages. Tap OK to save your change. The DIGIVAL prompts you to reboot. When the DIGIVAL is powered on again, screens are displayed in the selected language.

  • Page 44: About (Digival ™ Information)

    - QC Tests: 0/100 Software Version: vA.B - Calibration Checks: 2/50 Region Code: eu Supported Test Types All trademarks referenced are trademarks of either the Abbott DIGIVAL Assay group of companies or their respective owners. IP Address: Unassigned Back Back...

  • Page 45: Reading A Test

    Section 14, "Care and Cleaning." Caution: Abbott assays may have varying CLIA complexity levels. Please ensure the CLIA complexity of the assay you are using is appropriate for your Laboratory." When the DIGIVAL is powered on, or after another operator has logged out, the Scan or Enter Operator ID screen displays.
  • Page 46 Scan or enter the Test Device ID. To scan: Place the barcode on • the foil pouch under the barcode scanner. To enter it manually: Tap Abc to • access the keypad and then ?123 to access the numeric keypad. Enter the number printed on the foil pouch (below the barcode) and then tap OK.
  • Page 47 Read Now Mode: At the read time • indicated in assay instructions, open drawer, insert test device, and close drawer to continue. Do NOT open drawer again until result is displayed. Walk Away Mode: Once the • test device is securely closed, immediately open the drawer, insert test device and close the drawer to continue.
  • Page 48 9. Open the drawer and discard the used Test Device. The Test Device can now be removed from the DIGIVAL and disposed of according to federal, state and local regulations. Do not reinsert test device once a result has been reported. Close the drawer.

  • Page 49: Reading A Qc Test

    10 Reading a QC Test Home>Read QC Test Abbott test kits contain positive and negative external controls. Refer to the product insert for the test that you are using for further information regarding the QC test requirements. Further controls may be tested in order to conform to local, state and/or federal regulations, accrediting groups, or the lab’s standard Quality Control procedures.
  • Page 50 STEP 3: Verify that the test type matches the QC sample intended for testing and tap OK to confirm. If the incorrect QC test has been selected tap Back to return to the previous screen. STEP 4: Refer to specific test Product Insert for QC preparation and test procedure.
  • Page 51 Con guración - Lista de bloqueados Read QC Test Tipo de prueba Review Result Step 6 of 7 de lote Test Type: DIGIVAL Assay 2 Control Type: Negative Control Control: Valid Lot #: 123456 Negative Control Passed Print STEP 6: When a test completes successfully, results are displayed on the screen, with Passed or Failed result.

  • Page 52: Printing Test Results

    Printing Test Results A printer for the DIGIVAL is optional and may be purchased from Abbott. See Section 20, "Ordering and Contact Information", for printer details and ordering information. When the printer is connected you can print patient test and QC test results after each test completes, or from the Test History screen.

  • Page 53: Test History

    12 Test History Home>Test History Test results from patients, QC tests Home admin 05/01/2018 03:31 pm and calibration check results are all stored in the DIGIVAL. To view this Calibration Read Test Read QC Test Test History Check Information, use the Test History screens.
  • Page 54 Home>Test History>QC Tests Tap QC Tests to view a list of all stored QC Test Results. Tap Actions to Delete All QC Test Results. Use the up and down arrows to scroll through the list. To select and view a particular result, tap the checkbox next to the lot number and tap Actions and then tap View.
  • Page 55 Re-enter the password and tap OK. CREATING A PASSWORD IS REQUIRED TO ACCESS THE DATA CONTAINED IN THE EXPORTED FILE. Abbott will not be able to assist with lost or forgotten passwords as this password is selected by the user.

  • Page 56: Software Updates

    13 Software Updates When new tests or software updates become available, the DIGIVAL can be updated by the Admin, using a USB memory stick supplied by Abbott at the time of the software update release. If a middleware system that supports instrument software updates is configured, the DIGIVAL can receive software updates over the network without the need for a USB memory stick.
  • Page 57 When the update is successful, restart the DIGIVAL, or wait for it to restart automatically. If unable to complete the software update, please contact Abbott Technical Support. Contact numbers can be found at the end of this user manual. DIGIVAL User Manual...

  • Page 58: Care And Cleaning

    14 Care and Cleaning Cautions: Do not disassemble or attempt to repair the DIGIVAL or other accessories as there is a risk of damage to the DIGIVAL. The DIGIVAL does not contain serviceable parts and should be returned for repair. Disassembling the DIGIVAL will also void the warranty.

  • Page 59: Accessories

    15 Accessories Accessories for use with the DIGIVAL can be ordered separately. To order, see Section 20, “Ordering and Contact Information.” DIGIVAL User Manual...

  • Page 60: Errors And Warnings

    This section provides troubleshooting steps for specific error and warning codes. If the warning or error persists after you have followed the instructions on the screen, contact Abbott Technical Support. Contact numbers can be found at the end of this user manual.

  • Page 61: Drawer Open

    E.6 Drawer Open Error: Drawer is open. Action: Close the drawer to continue. If the error persists, contact Abbott Technical Support. E.7 Test Device ID Invalid Error: Test device ID invalid. Action: Check foil pouch to ensure barcode was scanned or manually entered correctly.

  • Page 62: Incorrect Tray

    Action: Patient ID must be 2 to 20 characters long, contain only alphanumeric and some special characters, such as # () * /\ and have no spaces. Tap OK to try again. If the error persists, contact Abbott Technical Support. E.14 Test Device QR Code Read Failure Error: Test device QR code read failure.

  • Page 63: Calibration Check Card Qr Code Read Failure

    Card. Ensure Calibration Check Card is present and positioned correctly, QR code is not obscured and close drawer to continue. If problem persists replace Calibration Check Card and try again. If the error persists, contact Abbott Technical Support. E.19 Password Invalid Error: Password is invalid.

  • Page 64: Test History Export

    E.24 Test History Export Error: Test History export failed. Action: Check that the USB memory stick is connected, formatted correctly and that it has enough free memory. If the error persists, contact Abbott Technical Support. E.25 Operator Limit Reached Error: Operators cannot be created because the maximum operator limit has been reached.

  • Page 65: Qc Lot Number Invalid

    Error: Multiple update files were found on the USB Memory Stick. Action: Try again with a USB Memory Stick containing an update file. Note: For error codes not found in the user manual, please contact Abbott Technical Support. E.35 Synchronization Failed - Network Error: Network can not be reached.

  • Page 66: Assay Lot Number Is Locked Out

    Tap OK to try again. E.43 Lot ID Add Failed Error: Failure to Add Lot to the Blacklist. Action: Tap OK to try again. If problem persists, contact Abbott Technical Services. E.44 Lots Import Failed Error: Failure to import Lots from USB memory stick.

  • Page 67: Critical Errors

    ™ Error: DIGIVAL Instrument Fault. Action: Restart DIGIVAL and try again. If the error persist, make note of the fault code displayed and contact Abbott Technical Support. CE.4 Update Failed Error: Software update failed. Action: Please remove USB memory stick and restart update process. If problem persists, please contact Abbott Technical Support.

  • Page 68: Digival

    Restart Required DIGIVAL ™ Warning: The DIGIVAL will retart to activate new assay. Action: Tap OK to continue. W.6 Delete All Test History Warning: All patient test, QC test and calibration check results will be deleted. Action: Tap OK to delete all history or Cancel to stop test history deletion. Tap Home to stop test history deletion and return to home screen.

  • Page 69: Test Cancellation Attempt

    W.9 Test Cancellation Attempt Warning: This warning will appear during Walk Away mode if the user cancels the test while the timer is running. Action: Tap Yes to cancel or No to return to the test. W.10 Import All Operators Warning: Importing new operators will delete all existing operators and passwords.

  • Page 70: Symbols

    Symbols USB 2.0 high speed interface connector Wired ethernet, 10/100 Mb/s connector DC Power connector, for connection with 12V DC supplied external. Power supply and adaptor. 12VDC, 3.0 Amp maximum Biological hazard Caution, consult accompanying documents Restriction of hazardous substances compliant Waste electrical and electronic equipment directive compliant Serial number...
  • Page 71 Keep away from sunlight On-Off power button This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

  • Page 72: Digival ™ Specifications

    Automatic upload of test result (to a data management system) after completion of the reading process. Manual upload of test results from memory. Contact Abbott Technical Support for further information. Data storage 1000 patient test results 100 QC test results...

  • Page 73: Power Supply

    18.2 Power Supply 12V Power Supply Rated input voltage: 100-240VAC Rated input frequency: 50/60Hz Rated input current: 1.2 Amps Operating environment: As per DIGIVAL Storage environment: As per DIGIVAL Output voltage: 12V DC Output current: 3.0-3.5 Amps DIGIVAL User Manual...

  • Page 74: Warranty (En)

    If Abbott is unable to repair or replace any DIGIVAL to a condition as warranted, Buyer shall be entitled to a refund of the purchase price upon return of the defective DIGIVAL to Abbott.
  • Page 75 AND FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL ABBOTT BE LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL, CONSEQUENTIAL, OR PUNITIVE LOSS OR DAMAGES IN ANY WAY RELATED TO THE DIGIVAL, EVEN IF ABBOTT IS AWARE OF THE POSSIBILITY OF SUCH CLAIM OR DAMAGES. DIGIVAL User Manual...

  • Page 76: Ordering And Contact Information

    Abbott USB Memory Stick: EQ004003 Opticon Barcode Scanner: L22XWU1-200 20.2 Abbott Contact Information Further information can be obtained from your distributor, or by contacting Abbott Technical Support on: +1 888 735 5317 ts.scr@abbott.com Africa, Russia, CIS +44 161 483 9032 EMEproductsupport@abbott.com...
  • Page 80 Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, Maine 04074 USA www.abbott.com/poct © 2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. INLFR024 Rev. 4 2020/01...
  • Page 81 Printed Colors Abbott PN: INLFR024 DIGIVAL Rev: 4 CMYK User Manual, EN Incoming Inspection Colors (For Reference Only) Date of Last Revision: Colors below are not used for printing 4.11 2020/01/15 Size: PMS 2995 U 280 mm x 210 mm...

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