What to do if Quidel Sofia Measuring Instruments shows SD Card File Error?
If the Quidel Measuring Instruments displays 'SD Card File Error', it means the SD Card has the wrong format or the file was not found. Remove the SD Card and insert an approved SD Card from Quidel.
What to do if Quidel Sofia displays 'Firmware Upgrade Error'?
If your Quidel Measuring Instruments displays a 'Firmware Upgrade Error', it could be because the SD Card is not found or has the wrong format. Confirm that the correct SD Card was used and inserted correctly.
What to do if Quidel Sofia Measuring Instruments Calibration Check failed?
If the Sofia Calibration Check failed on your Quidel Measuring Instruments, it could be due to the Calibration Cassette being stored outside of its provided light-protecting pouch. Test the Calibration Cassette. If the calibration check does not pass or is invalid, contact Quidel Technical Support at 800.874.1517 to obtain a replacement Calibration Cassette.
How to fix paper out error on Quidel Measuring Instruments?
If the Quidel Measuring Instruments displays a 'Paper out error', it indicates that the device has detected a printer error or the printer is out of paper. To resolve this, check the printer paper and replace the roll if it's empty.
What to do if Quidel Sofia shows low battery warning?
If the Quidel Measuring Instruments displays 'Low Battery Warning', it means the batteries are running low. Connect the device to AC power or replace the batteries before starting another test.
Why is Barcode Scanner not working on Quidel Measuring Instruments?
If the Barcode Scanner isn't scanning or entering data on your Quidel Measuring Instruments, the scanner might be unplugged. Check the connection at the back of the unit to ensure it's properly connected.
What does Cassette Error mean on Quidel Measuring Instruments?
If the Quidel Measuring Instruments displays a 'Cassette Error', it means the Cassette barcode is invalid, missing, or unreadable. Retest using a Cassette with a valid barcode.
What does Cassette Reuse Error mean on Quidel Sofia?
If the Quidel Measuring Instruments displays a 'Cassette Reuse Error', it means the device has recognized that the Cassette has already been used. Use a Cassette that hasn't been previously run.
What does Device Type Error mean on Quidel Sofia?
If the Quidel Measuring Instruments shows a 'Device Type Error', it means the device type is incorrect. Retest using a Cassette of the correct device type.
What to do if Quidel Sofia shows SD Card error?
If the Quidel Measuring Instruments shows an 'SD Card error', the system isn't detecting the SD Card or it's not correctly inserted. To fix this, check the SD Card slot on the back of the unit and ensure the SD Card is properly installed.
Provides contact details for Quidel Technical Support, including phone, email, and website.
Explains the meaning of various labels and symbols used on the Sofia device and its packaging.
Outlines essential warnings, precautions, and limitations for safe and proper use of the Sofia device.
Details specific safety measures to reduce risks of electrical shock, UV exposure, and biohazards.
Describes the Sofia device's intended application as a benchtop analyzer for specific in vitro diagnostic assays.
Details the Sofia's use of fluorescent tags, internal procedural controls, and result display capabilities.
Explains the necessity and frequency of Calibration Checks and external Quality Control tests.
Discusses different development modes (WALK AWAY, READ NOW) for processing patient samples.
Differentiates between User/Operator and Supervisor roles and their respective access levels.
Details the Sofia's 3.5-inch diagonal color LCD display for user interaction.
Explains the numeric keypad and function buttons, including their icons, names, and uses.
Provides instructions for placing Sofia, ensuring adequate space, and connecting power and peripherals.
Details the steps for loading paper into the integrated printer of the Sofia device.
Guides the user on how to turn on the Sofia unit using the power switch and what to expect.
Describes the three types of cassette drawers available for Sofia and their compatibility with different assays.
Explains how to use the Up/Down arrows and other keys to navigate menu options on the Sofia.
Configures default modes, entry requirements, calibration/QC, and user access rights.
Configures system-wide settings like location, language, sound, date, and time.
Loads new Sofia test type files from an SD Card for assay recognition.
Loads new Sofia test type files from the Cloud, requiring Firmware 2.0 or higher.
Adds new users to the Sofia system, specifying ID, type (Operator/Supervisor), and name.
Allows editing of existing user names and details within the Sofia system.
Removes users from the Sofia system, highlighting ID requirements.
Accesses and filters records of previously run patient tests.
Accesses and reviews records of previously run Quality Control tests.
Accesses and reviews records of previously performed Calibration Checks.
Displays QC Kit/Lot status and expiration dates for assays.
Lists installed Test Types and their corresponding version numbers.
Displays firmware, bootware, hardware versions, scan count, and serial number.
Allows supervisors to view user details, including test types and result counts.
Displays system messages with corresponding codes, dates, and times.
Clones Sofia settings to an SD Card for duplication onto other Sofia units.
Loads settings from an SD Card onto another Sofia unit.
Exports test records (patient, QC, calibration) to an SD Card for backup or analysis.
Installs firmware updates from an SD Card or the Cloud to improve Sofia functionality.
Installs new Sofia firmware by loading it from an SD Card.
Installs new Sofia firmware by loading it from the Cloud.
Verifies the router connection to the Cloud for downloading firmware and other updates.
Installs language files from an SD Card or Cloud for display on the Sofia.
Loads a new language file onto the Sofia system using an SD Card.
Loads a new language file onto the Sofia system from the Cloud.
Verifies the router connection to the Cloud for downloading language files.
Details the process of using the Calibration Cassette to check Sofia's optics and functions.
Explains how calibration results are displayed ('Passed' or 'Failed') and stored.
Accesses and reviews records of Quality Control tests performed on the Sofia.
Choose between WALK AWAY or READ NOW modes for running patient tests.
Allows the user to select or change the development mode for running tests.
Instructions for entering or scanning the User ID for test initiation.
Instructions for entering or scanning the Patient ID for test initiation.
Instructions for entering or scanning the Order Number for test initiation.
Guides the user through the process of inserting the test cassette in WALK AWAY and READ NOW modes.
Describes the action of pressing START Test and inserting the cassette.
Explains how test results are displayed, printed, and how to handle invalid controls.
Configures IP address, network address, subnet mask, gateway, and port number.
Sets IP Address and Port Number for downloading Test Type Files, Language Files, or Firmware via Cloud.
Configures LIS address, port number, auto send, and queue results options.
Sends all results that have not yet been transmitted to the LIS.
Sends only the most recent result to the LIS.
Sends all available results to the LIS.
Sends all patient test results to the LIS.
Sends all Quality Control results to the LIS.
Verifies the connection to the Laboratory Information System.
Refer to separate instructions for setting up the Sofia with the Virena Router.
Configures IP address and network settings for the Sofia device.
Configures parameters for Surveillance Mode, including age, patient ID, order number, and auto send settings.
Verifies the connection to the SURV receiver for data transmission.
Screen for entering patient demographic data like age, status, and study codes.
Options for sending results (unsent, last, all) to the SURV receiver.
Notes that maintenance, except for basic tasks, must be performed by Quidel.
Details battery intended use, installation, and changing procedures.
Provides instructions to reduce risk of electrical shock during cleaning and cleaning solutions.
Step-by-step guide on how to remove the cassette drawer for cleaning.
Provides detailed technical specifications for the Sofia device and barcode scanner.
Lists common symptoms, causes, and actions for troubleshooting Sofia device issues.
Lists potential error codes, their descriptions, actions, and codes for troubleshooting.
Provides contact details for Quidel Technical Support, including phone, email, and website.
Explains the meaning of various labels and symbols used on the Sofia device and its packaging.
Outlines essential warnings, precautions, and limitations for safe and proper use of the Sofia device.
Details specific safety measures to reduce risks of electrical shock, UV exposure, and biohazards.
Describes the Sofia device's intended application as a benchtop analyzer for specific in vitro diagnostic assays.
Details the Sofia's use of fluorescent tags, internal procedural controls, and result display capabilities.
Explains the necessity and frequency of Calibration Checks and external Quality Control tests.
Discusses different development modes (WALK AWAY, READ NOW) for processing patient samples.
Differentiates between User/Operator and Supervisor roles and their respective access levels.
Details the Sofia's 3.5-inch diagonal color LCD display for user interaction.
Explains the numeric keypad and function buttons, including their icons, names, and uses.
Provides instructions for placing Sofia, ensuring adequate space, and connecting power and peripherals.
Details the steps for loading paper into the integrated printer of the Sofia device.
Guides the user on how to turn on the Sofia unit using the power switch and what to expect.
Describes the three types of cassette drawers available for Sofia and their compatibility with different assays.
Explains how to use the Up/Down arrows and other keys to navigate menu options on the Sofia.
Configures default modes, entry requirements, calibration/QC, and user access rights.
Configures system-wide settings like location, language, sound, date, and time.
Loads new Sofia test type files from an SD Card for assay recognition.
Loads new Sofia test type files from the Cloud, requiring Firmware 2.0 or higher.
Adds new users to the Sofia system, specifying ID, type (Operator/Supervisor), and name.
Allows editing of existing user names and details within the Sofia system.
Removes users from the Sofia system, highlighting ID requirements.
Accesses and filters records of previously run patient tests.
Accesses and reviews records of previously run Quality Control tests.
Accesses and reviews records of previously performed Calibration Checks.
Displays QC Kit/Lot status and expiration dates for assays.
Lists installed Test Types and their corresponding version numbers.
Displays firmware, bootware, hardware versions, scan count, and serial number.
Allows supervisors to view user details, including test types and result counts.
Displays system messages with corresponding codes, dates, and times.
Clones Sofia settings to an SD Card for duplication onto other Sofia units.
Loads settings from an SD Card onto another Sofia unit.
Exports test records (patient, QC, calibration) to an SD Card for backup or analysis.
Installs firmware updates from an SD Card or the Cloud to improve Sofia functionality.
Installs new Sofia firmware by loading it from an SD Card.
Installs new Sofia firmware by loading it from the Cloud.
Verifies the router connection to the Cloud for downloading firmware and other updates.
Installs language files from an SD Card or Cloud for display on the Sofia.
Loads a new language file onto the Sofia system using an SD Card.
Loads a new language file onto the Sofia system from the Cloud.
Verifies the router connection to the Cloud for downloading language files.
Details the process of using the Calibration Cassette to check Sofia's optics and functions.
Explains how calibration results are displayed ('Passed' or 'Failed') and stored.
Accesses and reviews records of Quality Control tests performed on the Sofia.
Choose between WALK AWAY or READ NOW modes for running patient tests.
Allows the user to select or change the development mode for running tests.
Instructions for entering or scanning the User ID for test initiation.
Instructions for entering or scanning the Patient ID for test initiation.
Instructions for entering or scanning the Order Number for test initiation.
Guides the user through the process of inserting the test cassette in WALK AWAY and READ NOW modes.
Describes the action of pressing START Test and inserting the cassette.
Explains how test results are displayed, printed, and how to handle invalid controls.
Configures IP address, network address, subnet mask, gateway, and port number.
Sets IP Address and Port Number for downloading Test Type Files, Language Files, or Firmware via Cloud.
Configures LIS address, port number, auto send, and queue results options.
Sends all results that have not yet been transmitted to the LIS.
Sends only the most recent result to the LIS.
Sends all available results to the LIS.
Sends all patient test results to the LIS.
Sends all Quality Control results to the LIS.
Verifies the connection to the Laboratory Information System.
Refer to separate instructions for setting up the Sofia with the Virena Router.
Configures IP address and network settings for the Sofia device.
Configures parameters for Surveillance Mode, including age, patient ID, order number, and auto send settings.
Verifies the connection to the SURV receiver for data transmission.
Screen for entering patient demographic data like age, status, and study codes.
Options for sending results (unsent, last, all) to the SURV receiver.
Notes that maintenance, except for basic tasks, must be performed by Quidel.
Details battery intended use, installation, and changing procedures.
Provides instructions to reduce risk of electrical shock during cleaning and cleaning solutions.
Step-by-step guide on how to remove the cassette drawer for cleaning.
Provides detailed technical specifications for the Sofia device and barcode scanner.
Lists common symptoms, causes, and actions for troubleshooting Sofia device issues.
Lists potential error codes, their descriptions, actions, and codes for troubleshooting.
General| Detection Method | Fluorescence |
|---|---|
| Result Time | 15 minutes |
| Humidity | 10-90% non-condensing |
| Assay Type | Immunoassay |
| Storage Temperature | 2°C to 30°C |
| Product Type | Point-of-Care Diagnostic |
| Technology | Fluorescence Immunoassay |
| Connectivity | USB |
| Operating Temperature | 15-30°C |
| Reportable Range | Qualitative (Positive/Negative) |
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