Abbott DIGIVAL LFR-024, User Manual

Page 1: ...LFR 024 USER MANUAL DIGIVAL...

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Page 3: ...DIGIVAL User Manual DIGIVAL User Manual...

Page 4: ...story Delete All Test History admin only Calibration Checks QC Tests Date and Time Settings admin only Administration Connectivity Test Settings Access Control Synchronize Now Preferences Sound Langua...

Page 5: ...Network Connectivity Auto Upload Results Middleware Software Update Administration Log Export Factory Reset Login Access Control Auto Log Out Admin Password Operators Date Date and Time Time Settings...

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Page 7: ...Scanner Onscreen Keyboard 14 6 DIGIVAL Calibration 15 7 Settings Menu Admin Access Only 17 7 1 Date and Time Admin Access Only 17 7 2 Access Control 18 7 2 1 Login Admin Access Only 18 7 2 2 Operators...

Page 8: ...nces Menu 36 8 1 Synchronize Now 36 8 2 Language 37 8 3 Sound 37 8 4 Screen 37 8 5 About DIGIVAL Information 38 8 6 Legal Notices 38 9 Reading a Test 39 10 Reading a QC Test 43 11 Printing Test Result...

Page 9: ...ed Server 57 E 24 Test History Export 58 E 25 Operator Limit Reached 58 E 26 Log Export Failed 58 E 27 Last Name Invalid 58 E 28 Date of Birth Invalid 58 E 29 Drawer Open 58 E 30 Assay Add Error 58 E...

Page 10: ...Delete All Patient Tests 62 W 6 2 Delete All QC Tests 62 W 6 3 Delete All Calibration Checks 62 W 7 Factory Reset 62 W 8 Calibration Check Card Expiring 62 W 9 Test Cancellation Attempt 63 W 10 Import...

Page 11: ...camera based instrument that detects the presence and identity of a completed rapid test analyzes the test and control line and displays the results positive negative or invalid on a display screen R...

Page 12: ...r 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 C...

Page 13: ...pen the DIGIVAL drawer during testing The test is not saved until the completed result is displayed Caution Do not reinsert test device once a result has been reported Caution Do not remove the USB me...

Page 14: ...8 1 2 1 3 4 5 2 1 3 DIGIVAL at a Glance DIGIVAL Front View 1 Power On Off Button 2 Test Insert Tray DIGIVAL Back View 1 Barcode scanner bracket location holes 2 USB port x1 3 Power connection 4 Ether...

Page 15: ...ean flat level and stable surface not in direct sunlight Do not drop the DIGIVAL Position the DIGIVAL with clear access to connectors Keep connected cables clear of work areas such that tripping or ca...

Page 16: ...w the DIGIVAL to adjust to room temperature for at least 30 minutes before using 3 Connect the barcode scanner holster to the bracket provided with the DIGIVAL using the thumbscrew 4 Connect the brack...

Page 17: ...d with external power connected A battery with lightning symbol will appear when power is connected When disconnected from power a battery symbol will appear with 3 or less bars depending on remaining...

Page 18: ...at least one operator so that you can perform a Calibration Check You can return to this screen to add the rest of the staff at any time See Section 7 2 2 1 Add a new Operator 6 Log out as the admin...

Page 19: ...Check See Section 6 DIGIVAL Calibration Test History See Section 12 Test History Settings Admin only See Section 7 Settings Menu Preferences See Section 8 Preferences Menu Log Out The time date and ba...

Page 20: ...meric and numeric keypads Information can be entered by tapping the keypad keys or by scanning with the barcode scanner Read Test Abc 123 n Scan or Enter Test Device ID Step 1 of 9 Figure 4 QWERTY Key...

Page 21: ...0 days an error message displays No tests can be processed until the calibration check is up to date Two Calibration Check Cards supplied with an expiry date are provided for this purpose Additional C...

Page 22: ...eaned using a soft lint free cloth to remove dust or debris Handle the calibration check card with gloves to prevent against fingerprints that may effect the reading Also see Section 16 E 18 If a prin...

Page 23: ...de Date and Time Access Control Test Settings Connectivity Administration Use the arrows on the right side of the screen to scroll through menus 7 1 Date and Time Admin Access Only To update the date...

Page 24: ...Settings Access Control Login Login allows the Admin to configure whether Operator ID passwords are required in order to allow access to the DIGIVAL The selected option will apply to all Operators wi...

Page 25: ...displayed 7 2 2 1 Add a New Operator To add a New Operator from Home Settings Access Control Operators Settings Operators Operator List Add Import All Export All Operator1 Back Actions Delete All 1 T...

Page 26: ...ol Operators Settings Operators Operator List Change Password Delete Operator1 Operator2 Operator3 Back Actions 1 Select the Operator by tapping the checkbox next to the operator s name Use the arrows...

Page 27: ...a current operator 1 From Home Settings Access Control Operators select the Operator by tapping the checkbox next to the operator s name Use the arrows at the bottom of the screen or swipe to move up...

Page 28: ...ontrol Operators tap Actions 2 Tap Import All 3 A Warning will display Importing an Operator List will delete all existing operators and passwords and will replace it with the new list Tap OK to conti...

Page 29: ...lly logged out after a specified time select Auto Log Out disabled and then tap OK Another Operator will not be able to log in until the current Operator logs out If you want Operators to be automatic...

Page 30: ...l data fields to be collected when running a test Choose Read Test for patient test options or Read QC Test for QC test options Choose one of the Read Test options to configure additional fields to be...

Page 31: ...gs QC Schedule The QC Schedule Menu allows the Admin to configure QC schedules for each assay Each assay has its own independent QC schedule settings Touch the row for any assay to configure its QC sc...

Page 32: ...all cases successful QC consists of a positive QC test and a negative QC test both with a result of Pass Select Days to configure a QC schedule that is based on the number of days since the last succ...

Page 33: ...say configuration Note Assay is already up to date will display on screen if attempt is made to add an existing assay 7 3 5 Walk Away Mode Home Settings Test Setting Walk Away Mode Use the Walk Away M...

Page 34: ...cify how Lot QC is handled Lot QC refers to the requirement of performing successful QC on any new lot of test devices prior to running patient tests with the lot When Lot QC is on the DIGIVAL checks...

Page 35: ...s Use Export All Lots on the DIGIVAL on which successful QC has been performed then Import All Lots on other DIGIVAL s To Import or Export All Lots tap the corresponding menu option The DIGIVAL displa...

Page 36: ...t screen Settings Blacklist Test Type Lot DIGIVAL Assay 2 004173 Delete Back Actions The list of blacklisted lots is displayed including the test type for each lot if applicable To remove a specific l...

Page 37: ...tivity menu to configure the DIGIVAL network interface and the connection to a middleware system With the appropriate middleware system these features allow patient test results to be transmitted elec...

Page 38: ...uld be configured according to information provided by your network administrator 7 4 1 1 Network Interface Settings Method To change the Method setting tap the Method line on the screen and the Edit...

Page 39: ...represents a number in the range 0 255 Tap OK to save the new value and return to the Middleware Settings menu To edit the Port setting tap the Port line and the Edit Property screen appears Use the...

Page 40: ...every 10 minutes to ensure it has the latest configuration settings operator list allowed lots list and other settings as configured in the middleware system 7 4 5 Purge Test Results Home Settings Co...

Page 41: ...rth are then displayed on the DIGIVAL so that the user can verbally confirm this information with the patient If this option is set to Warn the DIGIVAL allows the user to manually enter the name and d...

Page 42: ...t brightness of screen and enable screen saver About View information about the DIGIVAL Legal Notices View license information about open source software used in the DIGIVAL 8 1 Synchronize Now Home P...

Page 43: ...3 Sound Home Preferences Sound To turn sound on or off Tap the button next to Sound Off or Sound On Tap OK to save the settings and return to the Preferences Menu 8 4 Screen Home Preferences Screen R...

Page 44: ...Calibration Checks 2 50 All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners Preferences About Back The About screen displays information about...

Page 45: ...powered on or after another operator has logged out the Scan or Enter Operator ID screen displays 1 Enter your Operator ID using the barcode scanner or tap Abc to access the keypad and enter it manua...

Page 46: ...must be 2 20 characters may contain alphanumeric and special characters such as and and have no spaces Patient IDs are case sensitive User is prompted to enter additional patient fields if configured...

Page 47: ...tomatically upload test results the result will be uploaded to the configured middleware system at this point Caution Do NOT open the DIGIVAL drawer during testing The test is not saved until the comp...

Page 48: ...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 Cl...

Page 49: ...ation Check Test History Preferences Settings Log Out 05 01 2018 03 31 pm Home admin To read a QC Test tap Home Read QC Test This starts the DIGIVAL s Self Check The Scan or Enter Test Device ID scree...

Page 50: ...say 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...

Page 51: ...sult If a test error occurs Invalid displays Refer to specific package insert for further details on test result If the optional printer is set up tap Print to print the test result Tap Home to return...

Page 52: ...ion 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...

Page 53: ...History tap Test History A list of options displays Home Test History Patient Tests Tap Patient Tests to view a list of all stored Patient Test Results To view individual results use the up and down...

Page 54: ...checkbox next to the lot number and tap Actions and then tap View To print the result tap Print Home Test History Calibration Checks Tap Calibration History to view a list of all stored Calibration Ch...

Page 55: ...o automatically start export process Create a password when prompted during the export process 1 After inserting the USB memory stick use the keypad to enter the encryption password Passwords are case...

Page 56: ...if both are present To update the software tap Home Settings Administration Software Update 1 Insert the USB memory stick into one of the USB ports on the back of the DIGIVAL The DIGIVAL looks for an...

Page 57: ...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...

Page 58: ...rfaces and test device tray Clean the exterior DIGIVAL surfaces and the test device tray daily and immediately after possible patient sample contamination Acceptable cleaning agents include the follow...

Page 59: ...DIGIVAL User Manual 53 Accessories for use with the DIGIVAL can be ordered separately To order see Section 20 Ordering and Contact Information 15 Accessories...

Page 60: ...iled Action Tap OK and enter a correct operator ID and password If the error persists contact the Admin or contact Abbott Technical Support E 3 Operator ID in Use Error Operator ID is already in use A...

Page 61: ...re is up to date or tap OK to try again with a supported test device To check software version tap Home Preferences About The software version will indicate which test types are supported If problem p...

Page 62: ...ion are correct QR code is not obscured and close drawer to continue If error persists please contact Abbott Technical Support E 15 Test Device ID Mismatch Error Foil pouch barcode and test device QR...

Page 63: ...chnical Support E 20 Password Mismatch Error Password and Password Confirmation do not match Action Tap OK to try again Make sure that both passwords match Passwords are case sensitive If the error pe...

Page 64: ...memory If the error persists contact Abbott Technical Support E 27 Last Name Invalid Error The patient s last name is invalid Action Tap OK to try again Last name must be 2 20 characters long Field n...

Page 65: ...s 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 S...

Page 66: ...and less than 1000 for Rule under QC Lot Management Action Tap OK to try again E 42 Barcode Invalid Error Barcode is not valid Action Verify that pouch barcode was scanned or manually entered correct...

Page 67: ...stick and restart update process If problem persists please contact Abbott Technical Support 16 3 Warnings W 1 Memory Almost Full Warning Memory almost full Action Export test history to USB memory s...

Page 68: ...Cancel to stop test history deletion Tap Home to stop test history deletion and return to home screen Note Once test history is deleted results cannot be retrieved W 6 3 Delete All Calibration Checks...

Page 69: ...ognized Action Tap OK to continue and Back to re enter W 12 Patient Information is Incorrect Warning This warning alerts the user that the Patient ID is not correct Action Tap Yes to enter patient inf...

Page 70: ...connection with supplied external Power supply and adaptor 12VDC 3 0 Amp maximum Biological hazard Caution consult accompanying documents Restriction of hazardous substances compliant Waste electrica...

Page 71: ...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...

Page 72: ...results 100 QC test results 50 Calibration Check test results Memory allows user to review and print results until the results are uploaded to a data management system Power Supply 12V DC from externa...

Page 73: ...upply 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...

Page 74: ...ding disposable or consumable supplies against defects in materials and workmanship for two years from the date of purchase If Abbott receives notice of such defects during the two year warranty perio...

Page 75: ...person or 4 Operating the DIGIVAL outside of the environmental specifications of the product THE WARRANTY SET FORTH ABOVE IS EXCLUSIVE AND NO OTHER WARRANTY WHETHER WRITTEN OR ORAL IS EXPRESSED OR IMP...

Page 76: ...0 20 2 Abbott Contact Information Further information can be obtained from your distributor or by contacting Abbott Technical Support on US 1 888 735 5317 ts scr abbott com Africa Russia CIS 44 161 48...

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Page 80: ...ll trademarks referenced are trademarks of either the Abbott group of companies or their respective owners INLFR024 Rev 4 2020 01 IVD Abbott Diagnostics Scarborough Inc 10 Southgate Road Scarborough M...

Page 81: ...N Size 280 mm x 210 mm Printed Colors PN INLFR024 Rev 4 CMYK Incoming Inspection Colors For Reference Only Colors below are not used for printing Date of Last Revision 4 11 2020 01 15 PMS 2995 U Prima...