Quidel Sofia 2 User Manual
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Quidel Sofia 2 User Manual

Fluorescent immunoassay analyzer
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Summary of Contents for Quidel Sofia 2

  • Page 1 User Manual...

  • Page 2: Table Of Contents

    User Types ............................. 12 System Display ........................... 13 System Display ..........................13 Installation, Setup and Operation ..................... 13 Sofia 2 Setup ..........................13 Power Up ............................14 Supervisor Menu ..........................15 Logging in as Supervisor ......................15 Settings ............................15 Calibration and QC ........................
  • Page 3 View Lot Status .......................... 30 View Test Types ......................... 30 Run QC ............................31 QC Results ..........................31 Run Calibration ..........................31 Perform Sofia 2 Calibration Check ..................... 32 Calibration Results ........................32 Shutdown ............................32 Maintenance and Cleaning ......................32 Maintenance ..........................32 Battery Power ..........................

  • Page 4: General Information

    General Information Quidel Contact Information Contact Quidel Technical Support from 7:00 a.m. to 5:00 p.m. Pacific Time Tel: 800.874.1517 (in the U.S.); 858.552.1100 (outside the U.S.) Fax: 858.552.7905 Email: technicalsupport@quidel.com or contact your local distributor Website: quidel.com Page 3 of 40...

  • Page 5: Main Menu Structure

    Main Menu Structure Page 4 of 40...

  • Page 6: Labels And Symbols

    Labels and Symbols Label/Symbol Description Manufacturer In vitro diagnostic medical device Prescription use only Consult instructions for use Authorized representative in the European Community Temperature limitation Humidity limitation Waste electrical and electronic equipment (WEEE) Serial Number Catalog Number Warning/Caution Ultraviolet Radiation Potential Biohazard Page 5 of 40...

  • Page 7: Icons

    Icons Page 6 of 40...
  • Page 8 Page 7 of 40...

  • Page 9: Brief Warnings, Precautions And Limitations

     Contact Technical Support if the instrument is damaged.  Sofia 2 has been designed to CISPR 11 Class A. In a domestic environment, it may cause radio interference, in which case you may need to take measures to mitigate the interference.
  • Page 10  Clean Sofia 2 per the Maintenance and Cleaning section of this User Manual prior to return or disposal.  Sofia 2 must be disposed of in a safe and compliant manner. Applicable Federal, State and Local regulatory requirements shall be followed to ensure Sofia 2 is not disposed of as municipal waste.

  • Page 11: Introduction

    AWAY Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be read (READ NOW Mode). Sofia 2 will read the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Sofia 2 will display the test results.

  • Page 12: Development Modes

    In this mode, the User dispenses the patient sample into the Test Cassette and then immediately inserts the Test Cassette into Sofia 2. Sofia 2 will automatically allow the Test Cassette to develop for the required time period (pre- programmed for each test), read the Test Cassette, analyze and interpret the data, and automatically and objectively display the test result.

  • Page 13: User Types

    Sofia 2 consumable test kits, including Test Cassettes and External Quality Control materials, are supplied separately. Consult your Quidel representative for a listing of approved Sofia 2 assays. User Types Users without Supervisor authorization have access to the following functions: ...

  • Page 14: System Display

    Installation, Setup and Operation Sofia 2 Setup  Place Sofia 2 on the bench top. The unit is portable and can be moved to a suitable location for testing. Ensure counter top is stable, level, dry and free of obstructions.

  • Page 15: Power Up

    Power Port Sofia 2 will display the Power On progress screen and complete a Power On Self-Test. Once the Power On is complete, Sofia 2 will display the Run Test screen (Figure 3) and it is ready for use. Figure 3 When turning on Sofia 2 for the first time, a calibration check will be required (Figure 4).

  • Page 16: Supervisor Menu

    Sofia 2. Settings Entry to the Settings menu is accomplished by logging in as the Supervisor. Sofia 2 comes from the manufacturer with a default Supervisor login ID which should be changed when Sofia 2 is initially installed at the customer site.

  • Page 17: Calibration And Qc

    The Data Security screen allows the Supervisor to select the number of patient results that remain stored on Sofia 2. The Supervisor may also choose whether patient data is saved along with test data to an attached USB flash drive.

  • Page 18: Network Settings

    In the field, select either 12h or 24h. Use the on-screen keypad to enter the correct time. When the 12h format is selected, also select AM or PM. When the 24h format is selected, the AM/PM buttons are non-functional. If an invalid time is added, the field will highlight in red and the confirm button will not be available.
  • Page 19 Results, select either On or Off (Figure 6). Both settings must be set to On to send results to the Virena cloud daily. Upon activation of Sofia 2’s network capabilities, Sofia 2 will transmit data, de-identified in accordance with 45 C.F.R. § 164.514(b)(1), from the customer’s Sofia 2 to Quidel’s network of secured, third-party remote hosted servers.

  • Page 20: Test Virena Connection

    (Figure 9). If successful, the on-screen pop-up will display Test connection success. If unsuccessful, the on-screen pop-up will display Test connection error. If the connection test is unsuccessful after a second attempt, please contact Quidel Technical Support.

  • Page 21: Statistics

    Statistics View Analyzer Info The first screen of View Analyzer Info displays the Firmware Version, Hardware Version, No. of scans, and Serial Number (Figure 10). Select to continue to the next screen or to return to the Run Test screen. Figure 10 The second screen of View Analyzer Info displays the Ethernet MAC, WiFi MAC, Cellular firmware version, IMEI, and ICCID (Figure 11).

  • Page 22: View Message Log

    Figure 11 View Message Log View Message Log displays the Error Code, Date and Time (Figure 12). Select to return to the Run Test screen. Figure 12 Managing Users Page 21 of 40...

  • Page 23: Add User

    Add User To add a User, Select on the Add User screen (Figure 13). Use the on-screen keypad or barcode scanner to enter the User ID. User ID must be at least 4 digits. Then choose User Type by selecting Operator or Supervisor. Enter the name for the new user using the on-screen keypad.

  • Page 24: Delete User

    Figure 14 When the information is complete, press Delete User Select a User by touching anywhere within the row, then select to delete User (Figure 15). This action cannot be undone. If a User is deleted by mistake, re-add the User as described above.

  • Page 25: Export, Import, Delete

    Sofia 2 settings data. Once complete, it is safe to remove the USB flash drive. When cloning Sofia 2, all settings including Test Type Files will transfer over. User history, lot status, QC and test data will not transfer over.

  • Page 26: Import Settings From Usb Flash Drive

    Import Settings from USB Flash Drive To import the settings of one Sofia 2 onto another Sofia 2, insert the USB flash drive from the “Master” Sofia 2 that has the settings you wish to duplicate. in the first field to select Import.

  • Page 27: Run Test (Patient Specimens)

    Select , then select to import Sofia 2 firmware. Sofia 2 will complete a self-installation and then power up in the normal startup screen. Once complete, it is safe to remove the USB flash drive. Run Test (Patient Specimens) The Run Test screen can also be accessed by selecting on most screens.

  • Page 28: Enter The Order Number, If Applicable

    In the READ NOW development mode, remember to first manually time the test development of the patient specimen Test Cassette outside of Sofia 2 at room temperature for the required period of time (as defined in the assay-specific Package Insert) before proceeding to the next step.

  • Page 29: Patient Test Results

    . Insert the Test Cassette into the drawer and gently close the drawer (Figure 19). Figure 19 Upon closing the drawer, Sofia 2 will start automatically and display the progress on the screen. Patient Test Results When the test is complete, the results for both the patient specimen test(s) and for the internal procedural control will be displayed on the Sofia 2 screen and automatically saved on the device.

  • Page 30: Review Data

    If the procedural control is , repeat the test with a new patient sample and a new Test Cassette. To run another patient specimen, select to return to the Run Test screen. Review Data Review Patient Results Patient Results include the records for previously run patient tests. In any list of Patient Results, you may show the detailed results by selecting the result to view (Figure 20).

  • Page 31: Review Calibration Results

    Figure 21 Select to return to the Run Test screen. Review Calibration Results Sofia 2 Calibration Results include the records for previously run Calibration tests. A list of the calibrations performed will be displayed (Figure 22). Figure 22 Select to return to the Run Test screen.

  • Page 32: Run Qc

    QC process and return to the Run Test screen. If the QC controls do not pass, repeat the external control testing process or contact the Supervisor or Quidel Technical Support at 800.874.1517 (in the U.S.) for assistance before testing patient specimens. See page 3 for additional contact information.

  • Page 33: Perform Sofia 2 Calibration Check

    Maintenance and Cleaning Maintenance Note: Sofia 2 must be sent to Quidel if maintenance is required. The User should not attempt any maintenance except for changing the battery and cleaning the external surfaces and Cassette drawer.

  • Page 34: Battery Power

    To optimize instrument performance and charging, it is recommended that the battery remain installed in the instrument. Prior to replacing the battery, ensure that there is no cassette in Sofia 2. Then power down and unplug Sofia 2. Remove the battery cover on the rear of the instrument. Disconnect the battery cable and carefully slide out the battery (Figure 23).
  • Page 35 Removing the Drawer for Cleaning Ensure that there is no cassette in the drawer and unplug Sofia 2. Gently pull drawer out until it stops, then lift up Sofia 2 and press the button as shown (Figure 24). The drawer can then be removed.
  • Page 36 Figure 25 Gently slide the drawer until it is latched closed. If resistance is met or the drawer does not slide easily, check the alignment of the rails in the track. Go to the Main Menu and perform Calibration. Page 35 of 40...

  • Page 37: Appendices

    22 cm deep x 12 cm wide x 12 cm high Weight 2 lbs (1 kg) 100-240 VAC, 50/60 Hz, self-switching Power Supply Input (U.S./International), 2.93 Amp maximum Sofia 2 Input 7.5V DC 2.5A Replaceable Batteries LiPo rechargeable battery Display 4-inch color LCD touchscreen...

  • Page 38: Appendix B System Troubleshooting

    Note: The chart below describes the error messages that may be displayed while using Sofia 2. If unable to resolve the problem after troubleshooting, please record the error message and contact Quidel Technical Support. The error message will help Technical Support diagnose the problem.
  • Page 39 Retest using a Cassette of the VALID_FOR_ current test. correct device type. CURRENT_TEST MISSING_ASSAY_ Method file unavailable for Only test with approved Sofia 2 METHOD supplied assay type. assays. CASSETTE_ Cassette has previously been Use a Test Cassette that has PREVIOUSLY_USED used.
  • Page 40 Log file could not be Confirm correct USB flash drive ERROR successfully exported. was used and inserted correctly. LOW_BATTERY_ Battery is low. Connect Sofia 2 to AC power or WARNING charge battery before running another test. CALIBRATION_ERROR Calibration Failed. Contact Technical Support. POST_ERROR Power On Self Test Error.
  • Page 41 Enter an age between 1-129. age. TEST_CONNECTION_ Test connection error. Contact Technical Support. ERROR RESET_DEVICE_OR_ Please reset device or contact Restart Sofia 2 and if issue CONTACT_QUIDEL Quidel Technical Support. continues, contact Technical Support. 20299 – Sofia 2 Quidel Corporation 10165 McKellar Court San Diego, CA 92121 USA quidel.com...

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