User Manual
Table of Contents General Information ............................................................................................................................3 Quidel Contact Information .............................................................................................................3 Main Menu Structure ......................................................................................................................4 Labels and Symbols ...................................................
Enter the Patient ID ...................................................................................................................26 Enter the Order Number, if applicable ......................................................................................27 Change Development Mode ......................................................................................................27 Test Procedure ......................................................................................................
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.
Main Menu Structure Page 4 of 41
Labels and Symbols Label/Symbol Description Manufacturer In vitro diagnostic medical device 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 41
Icons Page 6 of 41
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Brief Warnings, Precautions and Limitations Always operate Sofia 2 on a surface that is level, dry, and not in direct sunlight. The Sofia 2 Calibration Cassette is sensitive to light. Store it in the opaque sleeve whenever it is not being used. Do not write on the barcode or surface of the Cassette. Never move Sofia 2 or open drawer while there is a test in progress. Use only the Power Adapter that was provided with Sofia 2. Do not drop Sofia 2 as it could damage the unit.
Potential Biohazard! To reduce the risk of biohazard: Dispose of used specimens in accordance with Federal, State and Local requirements. Treat specimens and patient samples as potentially biohazardous material. Ensure Sofia 2 is cleaned per the Maintenance and Cleaning section. Seek specific training or guidance if you are not experienced with specimen collection and handling procedures. Use of Nitrile, Latex, or other gloves is recommended when handling patient samples.
Introduction Intended Use Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays manufactured by Quidel Corporation. Sofia 2 is intended for professional and laboratory use.
Development Modes When a patient sample is added to the Test Cassette, it begins to flow through the test strip. The development time required varies by test type. Refer to the assay-specific Package Insert to determine the required development time of each test, and the required storage conditions of the test and external controls. The correct development time is required to get accurate results. Sofia 2 has been designed to operate in different development modes.
Additional Ancillaries (optional) Dymo LabelWriter 450 Printer (Part #1752264) Dymo Vinyl Label Roll, 2 5/16” x 4” (Part #30256) Replacement Battery Contact Quidel Technical Support for additional supplies at 800.874.1517 (in the U.S.). See page 3 for additional contact information. 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.
System Display System Display Sofia 2 contains a 4-inch color LCD display for interacting with the user interface (Figure 1). Figure 1 Touchscreen Display Barcode Scanner Cassette Drawer 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. Avoid direct sunlight. Ensure the bench provides adequate space for Sofia 2.
Power Up Turn Sofia 2 on using the power switch located on the rear panel (Figure 2). Figure 2 Power Switch USB Ports (2) Battery Compartment RJ45 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).
Figure 4 Supervisor Menu Logging in as Supervisor The Supervisor Menu allows the Supervisor to access additional functionality and security options depending on the work environment and the location of 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. The default Supervisor ID is 1234.
Set Entry Requirements Setting the Entry Requirements allows the Supervisor to control what information is provided before running a test. Note: User ID and Order Number can be set to Required or Optional. Patient ID can be set to Required, Optional or Disabled. When set to Required, the fields must be entered for the User to run a patient test. When the Entry Requirements are complete, continue to Set Default Mode and Timeout using .
Other Settings Set Site Name and ZIP Code The Site Name and ZIP Code settings set the name and location of the clinic, hospital, lab or physician’s office where Sofia 2 is being used. In the field for Site Name, use the on-screen keypad to enter the location name up to 20 characters and/or spaces. To delete a letter, press Pressing setting. on the keypad.
Network Settings Virena Settings Before configuring Virena, ensure that the correct ZIP Code has been entered in the Other Settings menu. See page 17 for additional information. On the first Virena Settings screen, Virena Domain Name is pre-populated and no additional user input is needed (Figure 5). Figure 5 Press to continue to the next screen. For Auto Send, select either On or Off. For Queue Results, select either On or Off (Figure 6).
Figure 6 Press to continue to the next screen. For Transmit Patient ID, select either On or Off. For Transmit Order Number, select either On or Off (Figure 7). Figure 7 Press to continue to the next screen. For Age Required, select either Yes or No (Figure 8). If set to Yes, the User will need to enter the patient’s age prior to running each test. Figure 8 Select to confirm configuration and return to the Run Test screen.
Test Virena Connection The final step of Virena configuration is to test the connection. This is accessed through the Export, Import, Delete screen in the Supervisor Menu. To test the connection, use or in the first field to select Test Connection. Then ensure that is selected and press to begin the connection test (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.
Figure 10 The second screen of View Analyzer Info displays the Ethernet MAC, WiFi MAC, Cellular Firmware Version, IMEI, and ICCID (Figure 11). Select to return to the Run Test screen. 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.
Managing Users 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. To delete a letter, press Pressing setting. on the keypad. at any time cancels all previous changes and returns the Name to the previous When the name is complete, press .
Figure 13 Edit User Select a User by touching anywhere within the row, then select keypad to edit the User information (Figure 14). . Use the on-screen 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.
Figure 15 Note: Maximum number of Users is 100. Export, Import, Delete Export, Import or Delete Data Types Supervisors may export, import or delete data to/from either a USB flash drive or the device (Figure 16). Most standard USB flash drives may be used with Sofia 2.
Figure 16 Export Settings to USB Flash Drive Supervisors may export the settings of one Sofia 2 to import to another Sofia 2. Use the or in the first field to select Export. In the next field, use or to select Settings. Insert a USB flash drive and select , then select complete, it is safe to remove the USB flash drive. to export Sofia 2 settings data. Once When cloning Sofia 2, all Users will transfer over. User history, lot status, QC and test data will not transfer over.
Import Firmware from USB Flash Drive Insert USB flash drive with the firmware to install. Use or in the first field to select Import. In the next field, use or to select Firmware. Ensure that is selected, 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. Import Assay Methods from USB Flash Drive Insert USB flash drive with the assay method to install.
Select the Patient ID field on the Run Test screen. Use the barcode scanner (Figure 17) to scan a Patient ID barcode from a patient chart or other source or manually enter the data using the on-screen keypad on Sofia 2. Figure 17 Enter the Order Number, if applicable Order Number can be entered using the barcode or manually using the on-screen keypad. Select the Order Number field on the Run Test screen.
Figure 18 Test Procedure In the WALK AWAY development mode, proceed directly to the next steps as soon as the patient specimen has been processed and added to the Test Cassette. Do not let the Test Cassette develop outside Sofia 2.
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. If configured, results may also be stored in the cloud using Virena. The results may be also be printed on an attached printer by selecting .
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). Figure 20 Select to return to the Run Test screen. Review QC Results QC Results include the records for previously run QC (Positive and Negative Control) tests. The operator is able to locate QC result details in the same manner as Patient Test Results (Figure 21).
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. View Lot Status QC Lot Status QC Lot Status displays the QC Kit/Lots of assays and their expiration dates. This information is captured by Sofia 2 when Quality Controls are run.
Select to return to the Run Test screen. Run QC External Quality Control (QC) may be tested to demonstrate that the assay-specific reagents, Test Cassettes and assay procedures are performing properly. To run the External Controls, refer to the assay-specific Package Insert for each specific test for step-by-step instructions. Note: When running Positive and Negative controls with a qualitative test, the Positive Control must be tested first before the Negative Control.
Calibration Check is a required function that ensures optimal performance by checking the internal Sofia 2 optics and functions. IMPORTANT: Calibration Check must be performed within 30 days, prior to testing any patient sample. Refer to the assay-specific Package Insert for Calibration Check frequency. Perform Sofia 2 Calibration Check Use the specific Calibration Cassette included with Sofia 2 for the Calibration Check. For replacement Calibration Cassettes, please contact Quidel Technical Support.
Battery Power Battery Intended Use Sofia 2 includes a rechargeable battery. The battery will automatically charge while plugged into AC power. Sofia 2 will automatically switch to battery power when AC power is not available. Battery Replacement Sofia 2 is shipped with an internal LiPo rechargeable battery with an expected life of approximately three years. Use only a Quidel-supplied Sofia 2 replacement battery.
Possible electrical shock: Turn off and unplug Sofia 2 prior to cleaning. Do not clean the ports on the back of the instrument. Do not immerse or spray Sofia 2 in liquid. Do not clean the underside of the instrument. Turn off and unplug Sofia 2 before cleaning. Use a soft cloth with 70% alcohol or 0.6% bleach solution to clean exterior of Sofia 2. Do not use soap or other solutions except those noted below. Wipe the external surfaces and cassette drawer only.
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.
Appendices Appendix A Technical Specifications Sofia 2 Dimensions Weight Power Supply Input Sofia 2 Input Replaceable Battery Display LAN Interface Operating Temperature Operating Humidity Operating Altitude Shipping and Storage Temperature Shipping and Storage Humidity 22 cm deep x 12 cm wide x 12 cm high 2 lbs (1 kg) 100-240 VAC, 50/60 Hz, self-switching (U.S./International), 2.93 Amp maximum 7.5V DC 2.
The following barcodes have been configured at time of shipment: 1D Barcodes: UPC-A CODE 11 UPC-E CODE 39 EAN – 13 WITH EXTENDED COUPON CODE CODE 93 AND 93i CODABAR CODE 128 INTERLEAVED 2 OF 5 GS1 DATABAR IATA CODE 2 OF 5 MSI 2D Barcodes: DATA MATRIX AZTEC CODE QR CODE Appendix B System Troubleshooting Error Messages Note: The chart below describes the error messages that may be displayed while using Sofia 2.
ID 12 Displayed Text Unreadable Cassette barcode. 13 Cassette not valid for current test. 14 Assay Method File unavailable for supplied Cassette. Cassette cannot be reused. 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Cassette drawer is open, unable to read barcode. Barcode scanning in progress. Cassette is past the expiration date. Please retest with a non-expired Cassette. Calibration period has expired and the instrument is locked until Calibration has been successfully completed.
ID Displayed Text 33 34 Supervisor ID should have between 412 characters. Last Supervisor cannot be changed. 35 Stray light or wrong Calibration. 36 Invalid Operator Number. 37 Logged-in User cannot be deleted. 38 Logged-in User cannot be changed to an Operator. Mains power must be supplied to upgrade. Please plug in to AC power and try again. USB storage device does not contain a valid upgrade file. 39 40 41 42 43 44 45 46 47 48 49 50 51 52 There was an error performing the upgrade.
ID 53 Displayed Text USB storage device does not contain Assay Methods. 54 Some files were not imported successfully. Action Ensure that correct Assay Method File has been downloaded from myquidel.com. Ensure that correct files have been downloaded from myquidel.com. 20299 – Sofia 2 MDSS GmbH Schiffgraben 41 30175 Hannover, Germany Quidel Corporation 10165 McKellar Court San Diego, CA 92121 USA quidel.
