User Manual
Table of Contents General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Quidel Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Main Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Supervisor Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Labels and Symbols . . . . . . . . .
General Information Sofia Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 View Analyzer Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 View User History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 View Message Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Load/Save . . . . . . .
Main Menu Structure Supervisor Menu Structure Add User Load Test Types User ID Edit User Manage Users Run Test Options Delete User Patient ID Load Settings from SD Card Hide Options Order # Run QC Load/Save Save Test Records to SD Card User ID Review Patient Results Send Unsent Results Review QC Results Send Last Results Review Calibration Results Send All Results Sent Results to LIS Review Data View Lot Status Main Menu Calibration Supervisor Menu Send Results Test LIS Connection U
Labels and Symbols Brief Warnings, Precautions and Limitations ◗ Always operate Sofia on a surface that is level and dry and not in direct sunlight. Label Description ◗ The Sofia Calibration Cassette is sensitive to light. Store it in the opaque sleeve it was shipped in whenever it is not being used. Manufacturer ◗ Never move Sofia while there is a test in progress. In vitro diagnostic medical device ◗ Use only the power adapter that was provided with Sofia.
Introduction 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 is cleaned per the Maintenance and Cleaning section prior to storage, transport or disposal. ◗ Seek specific training or guidance if you are not experienced with specimen collection and handling procedures.
Development Modes System Components 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. Inspect the shipping container for obvious shipping damage prior to opening. Unpack the shipping container and inspect the unit and components for damage.
System Display and Keypad User Types Users/Operators without Supervisor authorization have access to the following functions: • Power on Sofia System Display • Perform Calibration User/ Operator • Run QC (External Controls) Sofia contains a 3.5 inch diagonal color LCD display for interacting with the user interface. • Run Test With Patient Samples • Review Data (Calibration and QC) Instructions for these basic User functions are provided in the Basic User Instructions section.
Installation and Setup Figure 1 Sofia Setup Sofia Setup Paper Feed Eject Print Right Soft Key Left Soft Key Up/Down/ Left/Right Arrows ◗ Place Sofia on the bench top within reach of an electrical outlet. The unit is portable and can be moved to a suitable location for testing. Ensure counter top is stable, flat and dry. Avoid direct sunlight. ◗ Ensure the bench provides adequate space for Sofia and barcode scanner stand.
◗ SD Card – Proper insertion should follow the diagram label on Sofia. The SD Card should be inserted with the copper contact points facing away from the power switch with the notched corner facing down as shown (Figure 3). Power Up Turn Sofia on using the power switch located on the rear panel (Figure 5). . Hold the toggle switch down for 1-2 seconds until the screen illuminates. Figure 5 Barcode Scanner into PS2 Port Figure 3 SD Card Slot RJ45 DC Power . Cord into .
When turning on Sofia for the first time, the Calibration Overdue screen will display (Figure 7). It is recommended to setup Sofia before running a Calibration Check. Navigating the Menu Settings Use the Up/Down arrows in the circle just below the screen to highlight the desired options on the menu (Figure 9). Use the keys to the right and left of the circle just below the screen for SELECT, BACK, OK, CANCEL and MAIN MENU options.
Load Test Type File Using the Left/Right/Up/Down arrows, select a letter at a time and press OK to construct the name (Figure 10). Main Menu Supervisor Menu Load Test Types Manage Users Load/Save Update Statistics Settings Figure 10 Note: A new test type file is needed for each new assay or test. Select LOAD TEST TYPES from the Supervisor menu. Insert the SD Card with the test type files (blue) to be installed and select OK.
System Settings Set Default Mode and Print Options Default Mode Main Menu When the Supervisor sets Sofia to a certain default mode, then this will be the normal operating mode unless otherwise changed. Supervisor Menu Load Test Types Set Default Mode & Print Options Manage Users Load/Save Set Entry Requirement & Timeout Set Calibration & QC Update Statistics Set User Access Rights General Settings Settings Using the Up/Down arrows, select Mode.
Patient ID Required Set User Access Rights In the Set Entry Requirements and Timeout menu, using the Up/ Down arrows, select PATIENT ID. With the Left/Right arrows, select “Required” or “Optional.” The User Access Rights option allows Supervisor to determine if Operators have access to Patient Data. Use the Down arrow to highlight the next option. Press OK to confirm when changes are complete and return to the Settings screen.
Review Data Set Language and Sound Default Language Sofia allows for two languages to be programmed at all times. The first language is automatically default to English, and if another language is required, you may upload another language. This setting is used to select which language Sofia displays. Main Menu Run Test Using the Left/Right arrows, select English OR the other installed language (if installed) and press the Down arrow to select SET SOUND.
Review Calibration Results Sofia Calibration Results include the records for previously run Calibration tests. Sofia Statistics Main Menu A list of the calibrations performed will be displayed. Supervisor Menu Select the BACK button to return to the Review Data screen. Load Test Types View Lot Status Manage Users View Lot Status displays the Kit/Lots of assays and their expiration dates. This information is captured by Sofia when Quality Controls are run.
Load/Save Update Main Menu Main Menu Supervisor Menu Load Test Types Manage Users Load/Save Load Settings from SD Card Save Settings to SD Card Supervisor Menu Update Statistics Settings Save Test Records to SD Card Load Test Types Manage Users Load/Save Update Load Analyzer Software Statistics Settings Load Language File Save Settings to SD Card To save the settings of one Sofia onto another Sofia you may clone the settings of the first and duplicate onto additional Sofia.
Calibration Check Run QC Main Menu Run Test Run QC Review Data Main Menu Calibration Supervisor Menu Change Mode Calibration Check is a required function that ensures optimal performance by checking the internal Sofia optics and functions. IMPORTANT: Calibration Check must not exceed 30 days prior to testing any patient sample.
Set Development Mode and Start QC Select the desired development mode: WALK AWAY or READ NOW (see Development Modes section) by using the Left/Right arrows to highlight the desired mode (Figure 12). Run Patient Specimens Main Menu Run Test Run QC Review Data Calibration Supervisor Menu Change Mode IMPORTANT: Refer to the assay-specific package insert for each specific test for instructions on preparing Test Cassettes with patient samples.
Change Development Mode Enter the Order #, if applicable Main Menu Run Test Run QC Review Data Calibration Supervisor Menu Change Mode Use the arrows to highlight the Order # field on the Start Test screen. Use the barcode scanner to scan an order number barcode from a patient test requisition or other source or manually enter the data by selecting the alpha entry option and using the numeric key pad on Sofia. Test Procedure Select the desired development mode by using the Up/Down arrows.
Patient Test Results READ NOW Mode 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 screen. Use the READ NOW Mode to allow more efficient throughput of multiple tests which have been set up and developed on the benchtop prior to reading. The results will be automatically printed on the integrated printer if the Auto Print option has been selected as the default setting.
Continue adding the appropriate extracted specimen to its appropriate cassette 1 minute after each until all cassettes have been charged with specimen. Network Configuration Main Menu When the timer goes off for cassette #1, if required, input or scan the User ID, patient ID and order # into Sofia for cassette #1. Then insert cassette #1 into Sofia, Sofia will display the result in approximately . 1 minute. The tray will then open.
Laboratory Information System (LIS) Send Results to LIS Main Menu Main Menu Supervisor Menu Review Data Settings Send Results General Settings Set Location Name Set Language & Sound Set Data Send Results to LIS Set Time Set Network Configuration Set LIS Parameters LIS Parameters and Settings Select Set LIS Parameters, use the numeric keypad to enter the LIS Address in the form. Use the Up/Down arrows to select Port Number, then use the numeric keypad to enter number.
Surveillance Mode Surveillance Mode Set Up Note: If Sofia does not show Surveillance Settings as an option, Sofia will require an upgrade to firmware 1.3.1 or above.
Virena Router Connection Verification Performing Tests in Surveillance Mode Go to the Main Menu and select Run Test. Main Menu Enter (User ID, Patient ID and Order #) if required, then press Start Test. Patient Demographics screen (Figure 22).
Shutdown Changing Batteries Turn off the unit using the power switch in the rear of the unit. The “Shutting Down the system” screen will be displayed. Shutdown is complete when the screen goes dark. Once Sofia is properly powered off, gently place Sofia face down and remove the battery cover (Figure 23). Ensure that there is no Cassette in Sofia. Maintenance and Cleaning Turn off the unit using the power switch in the rear of the unit. The “Shutting Down the system” screen will be displayed.
Removing the Drawer for Cleaning After cleaning the Cassette drawer, insert it carefully by aligning the rails of the drawer into the tracks of Sofia (Figure 25). Power on Sofia. Press the eject button located on Sofia keypad. Gently pull drawer out until it stops then lift up Sofia as shown . (Figure 24). As shown in Figure 24, there is a “V” shaped slot on the underside of the drawer. Gently press this catch release with your thumb while slowly sliding the drawer out.
Appendices Appendix A Technical Specifications Dimensions Weight Power Supply Input Sofia Input Replaceable Batteries 100-240 VAC, 47-63 Hz, self-switching (U.S./International), 0.9-0.34 Amps max 6V DC 4.16A max 4x LR6-AA + 6V 4.16 A Numeric Display 3.
Barcode Scanner Appendix B System Troubleshooting The Opticon barcode scanner (Model OPR-2001) is shipped in the correct configuration and is ready for use after connecting to Sofia . via the PS2 port. Additional information may be obtained at . opticonUSA.com or by contacting Opticon technical support at 1.800.636.0090 x 2127. Symptom Cause Action Paper out error Sofia detects a printer error or that the printer is out of paper Check the printer paper and install a new roll if needed.
Error Messages Note: The chart below describes some of the error codes that may be displayed while using Sofia. If unable to resolve the problem after troubleshooting, please record the last six digits of the error code and contact Quidel Technical Support. The six digits will help Technical Support diagnose the problem. Error Description Description Language File Import Error Language file could not be Please confirm correct SD Card ###.###.061.034 successfully loaded. was used and inserted correctly.
Index 20221-Sofia . Software Version 1.0.0 or higher MDSS GmbH . Schiffgraben 41 . 30175 Hannover, . Germany Quidel Corporation 10165 McKellar Court . San Diego, CA 92121 . quidel.com 1203102EN00 (10/14) 58 AC Power Cord, 11 Access Patient Data, 25 Add User, 20 Sofia Calibration, 9 Sofia Setup, 15 Sofia Statistics, 29 BACKSPACE, 21, 25 Barcode Scanner, 11, 15, 17, 33, 54 Barcodes, 54 Batteries, 11, 48 Changing, 49 Type, 13 Calibration, 9 Calibration Cassette, 7, 9, 11, 32, .
Review Patient Results, 12, 27 Review QC Results, 27, 34 Run Patient Specimens, 35 Run QC, 33 Safety precautions, 7 SD Card, 11, 14, 16, 20, 30, 55 Send Results to LIS, 43 Set Calibration and QC, 24 Set Date, 26 Set Development Mode and Start QC, 34 Set Entry Requirement and Timeout, 23 Set Language and Sound, 26 Set LIS, 42 Set Location Name, 25 Set Sound, 26 Set Time, 26 Set User Access Rights, 25 Shipping and Storage Humidity, 53 Shipping and Storage Temperature, 53 Shutdown, 48 Supervisor Menu, 5, 22, 3
