Quidel Sofia 2 User Manual

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User Manual

For in vitro diagnostic use
Firmware v.1.12 or higher

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Table of Contents

General Information ............................................................................................................. 4

Quidel Contact Information .......................................................................................................... 4

Main Menu Structure ................................................................................................................... 5

Labels and Symbols ...................................................................................................................... 6

Icons ............................................................................................................................................. 8

Brief Warnings, Precautions, and Limitations ............................................................................. 10

Safety Precautions ...................................................................................................................... 10

Introduction ........................................................................................................................ 13

Intended Use .............................................................................................................................. 13

Product Description .................................................................................................................... 13

Calibration Check and Quality Control (QC) ............................................................................... 13

Development Modes .................................................................................................................. 14

System Components ................................................................................................................... 14

Sofia 2 ................................................................................................................................. 14

Additional Ancillaries (optional) .......................................................................................... 14

User Types .................................................................................................................................. 15

System Display .................................................................................................................... 16

System Display ........................................................................................................................... 16

Installation, Setup, and Operation ...................................................................................... 17

Sofia 2 Setup .............................................................................................................................. 17

Power Up .................................................................................................................................... 17

Calibration Check ....................................................................................................................... 20

Supervisor Menu ........................................................................................................................ 20

Logging in as Supervisor ...................................................................................................... 20

Settings ............................................................................................................................... 20

Set Entry Requirements ...................................................................................................... 21

Set Default Mode and Timeout ........................................................................................... 21

Calibration and QC .............................................................................................................. 21

Data Security ....................................................................................................................... 21

Other Settings ..................................................................................................................... 22

Network Settings ........................................................................................................................ 23

Network Interface ............................................................................................................... 23

LIS Settings .......................................................................................................................... 24

Virena Settings .................................................................................................................... 25

Test Virena Connection ....................................................................................................... 26

Connect to Quidel ............................................................................................................... 27

Software Updates ............................................................................................................... 28

Statistics ..................................................................................................................................... 29

View Analyzer Info .............................................................................................................. 29

View Message Log ............................................................................................................... 30

Managing Users .......................................................................................................................... 31

Add User ............................................................................................................................. 31

Edit User ............................................................................................................................. 32

Delete User ......................................................................................................................... 32

Export, Import, Delete ................................................................................................................ 33

Export, Import, or Delete Data Types .................................................................................. 33

Export Settings to USB Flash Drive ...................................................................................... 33

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Import Settings from USB Flash Drive ................................................................................. 34

Export Patient Data to USB Flash Drive ............................................................................... 34

Sofia 2 Firmware and Assay Methods ................................................................................. 34

Import Firmware from USB Flash Drive ............................................................................... 34

Import Assay Methods from USB Flash Drive ...................................................................... 35

Import Language Files from USB Flash Drive ....................................................................... 35

Run Test (Patient Specimens) ..................................................................................................... 35

Enter the User ID ................................................................................................................. 35

Enter the Patient ID ............................................................................................................ 36

Enter the Order Number, if applicable ................................................................................ 36

Change Development Mode ............................................................................................... 36

Test Procedure .................................................................................................................... 37

Press ................................................................................................................................ 37

Patient Test Results ............................................................................................................. 38

Review Data ............................................................................................................................... 38

Review Patient Results ........................................................................................................ 38

Review QC Results............................................................................................................... 39

Review Calibration Results .................................................................................................. 39

View Lot Status ................................................................................................................... 40

View Assay Methods ........................................................................................................... 40

Run QC ....................................................................................................................................... 40

QC Results ........................................................................................................................... 41

Run Calibration ........................................................................................................................... 41

Perform Sofia 2 Calibration Check ...................................................................................... 41

Calibration Results .............................................................................................................. 42

Send Data ................................................................................................................................... 42

Shutdown ................................................................................................................................... 43

Maintenance and Cleaning ......................................................................................................... 43

Maintenance ....................................................................................................................... 43

Battery Power ..................................................................................................................... 43

Sofia 2 Storage. ................................................................................................................... 43

Cleaning .............................................................................................................................. 44

Appendices ......................................................................................................................... 46

Appendix A Technical Specifications .......................................................................................... 46

Sofia 2 ................................................................................................................................. 46

Appendix B Optimizing Analyzer Placement ............................................................................... 47

Appendix C System Troubleshooting .......................................................................................... 47

Error Messages ................................................................................................................... 47

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General Information

Assistance

For questions regarding the use of this product, or to report a problem, please contact Quidel
Technical Support at 1.800.874.1517 (in the U.S.) or [e-mail]. If outside the
U.S., further information can be obtained from your distributor, or directly from Quidel at one of
the numbers listed below. Reference quidel.com to see more options for Support.

Region

Phone

E-Mail Address

Europe, Middle East and Africa

[phone] (main)
0 1800 200441 (toll free)

[e-mail]

Austria

[phone]

Belgium

[phone]

France

0 (805) 371674

Germany

[phone]

Netherlands

0 800 0224198

Switzerland

0 800 554864

United Kingdom

0 800 3688248

Ireland

[phone]

Italy

[phone]

North America, Asia-Pacific, Latin America

858.552.1100

[e-mail]

Canada

437.266.1704 (main)

888.415.8764 (toll free)

[e-mail]

China

0400 920 9366 or
[phone]

[e-mail]

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Main Menu Structure

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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
CE mark of conformity

Batch code

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Date of manufacture

Use-by date

Importer

Do not re-use

China RoHS

Patient number

Control

Prescription use only in the United States

Biological risks

Device for near patient testing

Device not for self testing

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Icons

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Brief Warnings, Precautions, and Limitations

◼ For in-vitro diagnostic use.
◼ For professional and near patient testing.
◼ For use by healthcare professionals.
◼ Always operate Sofia 2 on a surface that is level, dry, and not in direct sunlight.
◼ Do not stack or place objects on top of the Sofia 2. Maintain a 6” minimum clearance

around the sides and back of the Sofia 2.

◼ 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 the 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.
◼ 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.

◼ Do not immerse the Sofia 2 in water or any liquids.

Safety Precautions

Sofia 2 is designed to provide safe and reliable operation when used according to this User
Manual. If Sofia 2 is used in a manner not specified in the User Manual, the protection provided
by the equipment may be impaired.

All warnings and precautions should be followed in order to avoid unsafe actions that could
potentially result in personal injury or damage to the device.

Warning!

To reduce the risk of electrical shock:

◼ Unplug Sofia 2 before cleaning.
◼ Plug the device into an approved receptacle.
◼ Do not immerse in water or cleaning solutions.
◼ Do not attempt to open the enclosure.

Note: Significant Electrostatic Discharge (ESD) event(s) may permanently disable ethernet

port functionality. If this occurs, please use Wi-Fi or LTE (if available) as alternative

methods of communication or contact Customer Service.

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To reduce the risk of improper operation:

◼ Use of any cable or adapter other than those provided by the manufacturer could result in

increased electromagnetic emissions or decreased electromagnetic immunity of this

equipment.

◼ Ensure the device has a minimum separation distance of 12” for Portable RF

communications equipment (including peripherals such as antenna cables and external

antennas).

◼ Use of this equipment adjacent to or stacked with other equipment should be avoided.

Ultraviolet Radiation!

To reduce the risk of UV Exposure:

◼ Do not attempt to open or disassemble Sofia 2.
◼ Do not attempt to look inside Sofia 2 while operating.

Failure to follow these warnings will invalidate the warranty.

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.

Caution!

To reduce the risk of incorrect results:

◼ Sofia 2 should only be used by trained operators.
◼ Do not use if Sofia 2 is reporting an error condition that cannot be corrected.
◼ To obtain accurate results, refer to the assay-specific Package Insert for details on specific tests.
◼ Use the test kit within the expiration date.

To reduce the risk of Sofia 2 damage:

◼ Sofia 2 is designed for countertop operation.
◼ Sofia 2 is not designed to be stacked on top of each other.
◼ Do not obstruct the flow of air on each side of the unit.

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◼ Maintain 6” minimum clearance on all sides including the back of the device.
◼ Sofia 2 is not designed to withstand moisture, extreme humidity, or extreme temperatures.
◼ Sofia 2 is not designed to withstand severe shock or vibration.
◼ Do not open or disassemble the device.

Failure to follow the precautions mentioned above will invalidate the warranty.

To reduce the risk of environmental contamination:

◼ Contact Quidel Technical Support at 800.874.1517 for the return or disposal of Sofia 2. See

page 3 for additional contact information.

◼ 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. If you are unsure of the proper methods for disposal, contact a certified

waste broker for guidance.

Note: Medical equipment that may have come into contact with potentially infectious materials
(e.g., patient samples, blood, serum, etc.) must be properly decontaminated prior to disposal or
recycling.

Limited Warranty: For warranty information and specific coverage terms, please refer to the
contract or other agreement under which the product was purchased, or contact Quidel Technical
Support, your local distributor or your Quidel representative for assistance.

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Introduction

Intended Use

Sofia 2 is a benchtop 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.

Rx Only

After the patient sample has been added to the Test Cassette, depending upon the User’s choice,
the Test Cassette is either placed inside of Sofia 2 for automatically timed development (WALK
AWAY Mode) or placed on the counter or benchtop 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.

Refer to assay-specific Package Insert for details on specific tests.

Product Description

Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate
specific results.

In each test, an internal procedural control line is also read. This ensures that sample flow has
occurred within the Test Cassette to permit an accurate reading.

Sofia 2 then displays the test results to the User on the screen and automatically saves them on
the device. If configured, the results may also be sent to an attached printer or stored in the cloud
using Virena®.

Calibration Check and Quality Control (QC)

Sofia 2 Calibration Check and External Quality Control Tests must be performed on a periodic
basis.

◼ Sofia 2 Calibration Check: Calibration Check is a required function that checks the internal

Sofia 2 optics and systems. A Calibration Check must be performed every 30 days or less.

A special Calibration Cassette is provided with Sofia 2. For replacement Calibration

Cassettes, contact Quidel Technical Support.

◼ External Quality Controls: Refer to assay-specific Package Insert for details on specific

tests.

Instructions are provided in the Run Calibration and Run QC sections.

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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. The Supervisor and User
can identify the mode that works best with their workflow and testing volume.

WALK AWAY Mode may be the most convenient for reading a single patient sample, as the User
can walk away during the development period. Sofia 2 has the capability of two different WALK
AWAY Modes: User-selected WALK AWAY Mode and LOCKED WALK AWAY Mode.

◼ User-selected WALK AWAY Mode may be the most convenient for reading a single patient

sample, as the User can walk away during the development period. 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. Depending on

the test, Sofia 2 may also read the Test Cassette periodically during the development time

and display a positive result prior to the final test time.

◼ LOCKED WALK AWAY Mode can only be selected while logged in as a Supervisor. In this

mode, Sofia 2 has been locked into WALK AWAY development timing for ALL assays run on

the analyzer. READ NOW development timing will not be available when this Default Mode

has been selected.

READ NOW Mode may be most convenient for high volume situations as Sofia 2 can quickly read
multiple patient samples sequentially. The User dispenses the patient sample into the Test
Cassette. The User then manually times the development period outside of Sofia 2. This can be
done on the counter or benchtop using a timer. Refer to the assay-specific Package Insert for the
required development time. Once the development time is complete, the User inserts the Test
Cassette into Sofia 2. Sofia 2 will immediately read and display the test result within 1 minute.

System Components

The following system components are supplied with Sofia 2:

Sofia 2

◼ Sofia 2 with Rechargeable Battery
◼ Power Adapter (Meanwell P/N: GSM25B07-P1J or equivalent)
◼ QuickStart Guide
◼ Calibration Cassette

Additional Ancillaries (optional)

◼ Dymo LabelWriter 450 Printer (Part #1752264)

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◼ Dymo LabelWriter 4XL Printer (Part #1755120) for Firmware 1.13.4 or higher only
◼ 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.

User Types

Users without Supervisor authorization have access to the following functions:

User/Operator

◼ Power on Sofia 2
◼ Perform Calibration
◼ Run QC (External Controls)
◼ Run Test with Patient Samples
◼ Review Data (Patient, Calibration, and QC)
◼ Send Data and Test Connection to Virena

Users with Supervisor authorization access can perform all of the following functions:

Supervisor

(Must have a valid log-in

to access Supervisor Menu.)

◼ Import Assay Methods
◼ Add or Delete Users
◼ Export and Import Settings
◼ Update Sofia 2 Firmware

◼ Import Language Files
◼ View Message Logs
◼ Review Statistics
◼ Change Settings

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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

Cassette Drawer

Barcode Scanner

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Installation, Setup, and Operation

Sofia 2 Setup

◼ Place Sofia 2 on the benchtop. The unit is portable and can be moved to a suitable

location for testing. Ensure the countertop is stable, level, dry, and free of
obstructions. Avoid direct sunlight.

◼ Ensure the bench provides adequate space for Sofia 2 and a 6” minimum clearance

around the unit. There must be space to allow adequate ventilation and to open/close
the Sofia 2 drawer and access the connection ports on the back of the unit.

◼ Connect the AC Power Cord to the Power Adapter and ensure the cord is seated into

the Power Adapter.

◼ Plug the Power Adapter with the round plug head into the power port on the back of

Sofia 2. Then plug the AC Power Cord attached to the Power Adapter into an
available electrical outlet.

◼ If using the optional Dymo Label Printer, connect to Sofia 2 by plugging into a USB

port on the back of the instrument (Figure 2).

Power Up

Turn Sofia 2 on using the power switch located on the rear panel (Figure 2).

Figure 2

Battery Compartment

Power Port

RJ45

USB Ports (2)

Power Switch

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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

After a Firmware update, or when turning on Sofia 2 for the first time, the User may see
several screens upon startup designed to personalize their Sofia 2 settings.

Zip Code:

Sofia 2 will prompt the User to enter the ZIP Code where it is located (Figure 4). Select to
confirm and continue to the next screen.

Figure 4

Time and Date:

After a Firmware update, the User will be prompted to verify that the time and date
displayed are correct. If they are, press to confirm the settings (Figure 5). If changes are
required, please refer to the Set Time and Date section on page 21 of this User Manual for
step-by-step instructions detailing how to update the Time and Date settings. Once
complete, press to confirm the settings.

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Figure 5

Software Updates:

Sofia 2 will prompt the User to set their software update settings (Figure 6). The “Download
from Quidel” options enable Sofia 2 to automatically download software updates directly

from the cloud via a Wired Ethernet or Wi-Fi connection.

Figure 6

To Connect to Quidel, Users will select their preferred installation method under “Download
from Quidel” and press . If the Sofia 2 is already connected to the internet the User will

receive confirmation of successful registration and will push again to advance to the Run
Test screen.

If the Sofia 2 is not already connected to the internet, Sofia 2 will prompt the User to set up
their network and will take the User to the Network Interface screen to do so (page 21).

Users also have the option to opt-out of connecting their instrument to Quidel and to
continue to download and install updates manually with a USB drive. Those who decide not

to Download from Quidel will select “Install updates manually with a USB drive”, then

press to return to the Run Test screen.

For more information on each option, refer to Connect to Quidel on page 25.

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Calibration Check

A Calibration Check must also be performed before using Sofia 2 for the first time (Figure 7).

The default Supervisor ID (1234) will be used for the Calibration Check.

Figure 7

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

Note: If the factory default ID is deleted and all other Supervisor codes have been
misplaced or forgotten, please call Quidel Technical Support for a 1-day temporary
Supervisor ID code that will allow the User to create a new Supervisor ID code. Contact
Quidel Technical Support for assistance at 800.874.1517 (in the U.S.). See page 3 for
additional contact information.

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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.

When the Entry Requirements are complete, continue to Set Default Mode and Timeout
using .

Set Default Mode and Timeout

Default Mode
When the Supervisor sets Sofia 2 to a certain default mode, this will be the normal
operating mode unless otherwise changed by the Supervisor or Operator.

Select either WALK AWAY, READ NOW, or LOCKED WALK AWAY development mode.

Idle ID Timeout
The Idle ID timeout sets the amount of time that a User ID remains entered and active as a
User in running various tests and activities. After the timeout period has expired, the User
must re-enter their ID number.

Using the on-screen keypad, enter the number of minutes for the timeout from 1-20. Press

to confirm when changes are complete to return to the Run Test screen.

Calibration and QC

Calibration Reminder

Using the on-screen keypad, enter the number of days for the Calibration reminder interval
from 2-30. When the selected number of days remains until the required Calibration, the
reminder will appear next to the menu icon on the Run Test screen. Press to confirm
when changes are complete to return to the Run Test screen.

Data Security

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.

In the Stored Patient Data field, use the on-screen keypad to enter the number of patient
results saved on the device from 1-1000.

In the Save Patient Data to USB field, select On or Off. If set to On, patient data will be
saved along with test records when exporting to an attached USB flash drive. A USB flash

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.

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drive must be attached prior to beginning a test for that result to be saved. Press to save
the configuration and return to the Run Test screen.

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 on the keypad.

Pressing at any time cancels the changes and returns the Site Name to the previous
setting.

In the field for ZIP Code, use the on-screen keypad to enter the 5-digit ZIP Code. The ZIP
Code entered for the facility in MyVirena must be used to successfully configure Virena.

When the Site Name and ZIP Code are complete, continue to Set Language and Sound by
pressing .

Set Language and Sound

Sofia 2 can be set to display languages that were previously installed from the Export,
Import, Delete menu (page 31).

Use or to select the appropriate language. This language will be displayed once the User
returns to the Run Test screen.

Setting the Sound on Sofia 2 will allow the Supervisor to turn on or off the beep
sound for notifications or when a barcode is scanned.

When the Sound is set, continue to set Barcode and Autoprint using .

Set Barcode Mode and Autoprint Mode
The Barcode Mode option allows for automatic or manual barcode scanning. When set to
automatic, the barcode scanner will always be on. When set to manual, the barcode scanner

will be off until the barcode scanner icon, , is pressed. This icon will be found on the
home screen. Press and the barcode scanner will illuminate for five seconds.

The Autoprint Mode option allows for the automatic printing of Patient, QC, and Calibration
results if the optional Dymo Labelwriter 450 is attached.

When the Barcode and Autoprint modes are set, continue to set Time and Date using .

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Set Time and Date

The Time option allows for two different time formats to suit specific country requirements.

The User can change the displayed time format to 12h or 24h format.
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 will not be available.

The Date option allows for two different date formats to suit specific country requirements.

In the field, the User can select the date format as either mm/dd/yy or dd/mm/yy
format. Use the on-screen keypad to enter the correct date. If an invalid date is added, the
field will highlight in red and the will not be available.

Press to confirm when changes are complete to return to the Run Test screen.

Network Settings

Network Interface

Wired Ethernet: For Set IP Address, select Manual or DHCP. If DHCP is selected, select to
test the connection and return to the Run Test screen. If Manual is selected, press to

continue to the next screen. Using the on-screen keypad, enter information for IP Address,
Subnet Mask, and Gateway. Press to continue to the next screen. Using the on-screen

keypad, enter the information for Primary DNS and Secondary DNS. Select to test the
connection and return to the Run Test screen.

Wi-Fi: Select your Wi-Fi network from the list of available options while considering each
network’s signal strength. Enter the Wi-Fi Password and press to test the connection.

Press to save the configuration and return to the Run Test screen.

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The Quidel Service Status button allows the User to check their Network Type, Internet
Access, Quidel Service Access, and the progress of any Firmware downloads that are
currently in progress. This screen can be helpful for calls with Quidel’s Customer Support
team (Figure 8).

Figure 8

LIS Settings

Use the on-screen keypad to enter the LIS IP Address. LIS Port is pre-populated, and no
additional user input is needed (Figure 9).

Figure 9

Press to continue to the next screen. For Auto Send, select either On or Off. If set to On,
test results will automatically be sent to the LIS as tests are run. If set to Off, test results will
need to manually be sent to the LIS. See the Send Data section on page 40 for additional

information. Press to continue to the next screen and select either ASTM or POCT1-A as
your preferred connection protocol. Press to test the connection. Select to confirm

configuration and return to the Run Test screen.

The option to test the connection by pressing on the LIS Settings screen is only available
for Sofia 2’s that are Connected to Quidel (page 25). Users with a Sofia 2 that is not
Connected to Quidel may also refer to the Send Data section on page 40 for an alternative
way to check their LIS connection.

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Virena Settings

Before configuring Virena, ensure that the correct ZIP Code has been entered upon initial
startup or in the Other Settings menu. See page 20 for additional information.
On the first Virena Settings screen, Virena Domain Name is pre-populated, and no
additional user input is needed (Figure 10).

Figure 10

Press to continue to the next screen.

For Enable Sending Of Test Results To Virena, select either On or Off. For Auto Send, select
either On or Off (Figure 11). If Auto Send is set to on, Sofia 2 will send results to Virena
when idle. If Auto Send is set to off, the instrument will never send results unless the User
manually decides to do so via the Send Data screen (page 40). If Enable Sending Of Test
Results To Virena is set to Off, the Auto Send options will no longer be selectable because
no results can be sent to Virena.

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.

Figure 11

Note: Virena functionality using a wireless cellular connection is currently only available

within the US. Presently, outside of the US, Virena must be configured using an Ethernet or
WiFi connection.

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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 12). This information is used for study purposes only and this information
will not be transmitted regardless of the selection.

Figure 12

Press to continue to the next screen.
For Age Required, select either Yes or No. If set to Yes, the User will need to enter the

patient’s age prior to running each test (Figure 13).

Figure 13

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. To do this, go to the Send
Data screen (page 40). Select Test Connection and press to begin the connection test

(Figure 14).

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Figure 14

If the Sofia 2 is Connected to Quidel, the User can also test their Virena connection by
pressing the icon on the Virena Settings home screen (seen in Figure 10). However, the

will only be visible on this screen if the Sofia 2 is Connected to Quidel. Instructions on

how to Connect Sofia 2 to Quidel can be found in the next section.

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.

Connect to Quidel

The Connect to Quidel screen allows the Supervisor to automatically download Sofia 2
software updates directly to their device from the cloud via a Wired Ethernet or Wi-Fi
connection (Figure 15).

Figure 15

To Connect to Quidel, Users will select their preferred installation method under “Download
from Quidel”.

• I will choose when to install new updates - Users will be alerted by the Load data

icon on their home screen when an update is available for installation. At their
convenience, the User can navigate to Software Updates (page 26) and press
“Update Now” to install the update.

Page 28 of 51

• Install new updates after logout - Sofia 2 will automatically install software updates

at a pre-set time after logout. If the User wishes to modify this pre-set update time,
they can do so via the Software Updates screen in the section below.

Once the preferred “Download from Quidel” method has been selected, press to save the
configuration and test the Network Connection. If the Sofia 2 is already connected to the

internet the User will receive confirmation of successful registration and will push again
to advance to the Run Test screen.

If the Sofia 2 is not already connected to the internet, Sofia 2 will prompt the User to set up
their network and will take the User to the Network Interface screen to do so (page 21).
Users also have the option to not connect their instrument to Quidel and to continue to
download and install updates manually with a USB drive. Those who decide not to

Download from Quidel will select “Install updates manually with a USB drive”, then press
to return to the Run Test screen.

Software Updates

The Software Updates screen is only displayed if the Sofia 2 is Connected to Quidel.

For “Select when you would like to install software updates” the User should select the
option that best fits their needs.

If the User selects “I will choose when to install new updates” they will press to confirm
the selection and return to the Run Test screen. With this option, Sofia 2 will alert the User

when a new update is available with the Load data icon on the home screen. When the
User is ready to install the update, they will revisit this screen and press “Update Now”. The
“Update Now” button will only appear if a Software Update is available (Figure 16).

Figure 16

If the User selects “Install new updates automatically” a dropdown menu will appear to
allow the User to select how many hours after logout they would like Sofia 2 to wait before
the software installation begins (Figure 17). After the selection is made, press to save the
configuration and return to the Run Test screen.

Page 29 of 51

Figure 17

Statistics

View Analyzer Info

The first screen of View Analyzer Info displays the Firmware Version, Hardware Version,
Number of Tests, Serial Number, IP Address, and LUT Version (Figure 18).

Select to continue to the next screen or to return to the Run Test screen.

Figure 18

Page 30 of 51

The second screen of View Analyzer Info displays the Ethernet MAC, Wi-Fi MAC, Wi-Fi SSID,
Cellular Firmware Version, IMEI, and ICCID (Figure 19).

Select to return to the Run Test screen.

Figure 19

View Message Log

View Message Log displays the Error Code, Date, and Time (Figure 20).

Select to return to the Run Test screen.

Figure 20

Page 31 of 51

Managing Users

Add User

To add a User, select on the Add User screen (Figure 21).

Use the on-screen keypad or barcode scanner to enter the User ID. User ID must be at least
4 digits.

Choose User Type by selecting Operator or Supervisor.

Enter the Name of the new User using the on-screen keypad.

To delete a letter, press on the keypad.

Pressing at any time cancels all previous changes and returns the Name to the previous
setting.

When the name is complete, press .

Figure 21

Page 32 of 51

Edit User

Select a User by touching anywhere within the row, then select . Use the on-screen
keypad to edit the User information (Figure 22).

Figure 22

When the information is complete, press .

Delete User

Select a User by touching anywhere within the row, then select to delete User (Figure 23). This
action cannot be undone. If a User is deleted by mistake, re-add the User as described above.

Figure 23

Page 33 of 51

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 24). Most standard USB flash drives may be used with Sofia 2.

Figure 24

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 to export Sofia 2 settings data. Once
complete, it is safe to remove the USB flash drive.

When cloning Sofia 2, all Users will transfer over. User history, lot status, QC, and test data
will not transfer over.

Note: Maximum number of Users is 1000.

Page 34 of 51

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.

Use or in the first field to select Import.

In the next field, use or to select Settings.

Ensure that is selected, then select to import Sofia 2 settings data. Once complete, it
is safe to remove the USB flash drive.

Export Patient Data to USB Flash Drive

Supervisors may export the patient data from Sofia 2 to a USB flash drive.

Use the or in the first field to select Export.

In the next field, use or to select Patient Data.

Insert a USB flash drive and select , then select to export Sofia 2 settings data. Once
complete, it is safe to remove the USB flash drive.

Sofia 2 Firmware and Assay Methods

Occasionally, Quidel will release Firmware and Assay Method updates to improve the
functionality of Sofia 2. It is recommended that Users ensure that their Sofia 2 has the most
current firmware, assay methods, and language files by Connecting their Sofia 2 to Quidel
via the Connect to Quidel screen on page 25 of this User Manual. If the Sofia 2 is Connected
to Quidel the instrument will automatically download these updates.

If the User opts out of Connecting their Sofia 2 to Quidel, they may still get these updates by
creating an account and registering their Sofia 2 at myquidel.com. After the Sofia 2 is
registered at myquidel.com, Supervisors may install the updates using a USB flash drive. To
do this, follow the instructions on myquidel.com.

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.

Note: When importing settings from one Sofia 2 to another, patient and QC results on
the incoming Sofia 2 will be deleted.

Page 35 of 51

Ensure that is selected, then press 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.

Use or in the first field to select Import.

In the next field, use or to select Assay Methods.

Ensure that is selected, then press to import Sofia 2 assay methods. Sofia 2 will
complete a self-installation and return to the previous screen. Once complete, it is safe to
remove the USB flash drive.

Import Language Files from USB Flash Drive

Insert USB flash drive with the language file to install.
Use or in the first field to select Import.

In the next field, use or to select Language Files.

Ensure that is selected, then press to import Sofia 2 language files. Sofia 2 will
complete a self-installation and return to the previous 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.

Enter the User ID

The User ID can be entered using the barcode scanner or manually using the on-screen
keypad.

Select the User ID field on the Run Test screen. Use the barcode scanner (Figure 25) to scan the
barcode from a User’s ID Card or manually enter the data using the on-screen keypad on Sofia 2.

Page 36 of 51

Enter the Patient ID

Patient ID can be entered using the barcode or manually using the on-screen keypad.

Select the Patient ID field on the Run Test screen. Use the barcode scanner (Figure 25) 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 25

Enter the Order Number, if applicable

The 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. Use the barcode scanner to scan an
order number barcode from a patient test requisition or other source or manually enter the
data using the on-screen keypad on Sofia 2.

Change Development Mode

Select the desired Development mode: WALK AWAY or READ NOW (See the description of
the WALK AWAY and READ NOW development modes on page 12).

The current development mode will be highlighted below the Order Number field (Figure

26). If the highlighted mode is the desired mode, no changes are required.

Figure 26

IMPORTANT: Refer to the assay-specific Package Insert for each specific test for

instructions on preparing Test Cassettes with patient samples.

Page 37 of 51

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.

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.

To access additional detail on the two development modes from the Run Test screen select

. To return to the Run Test screen from the pop-up, select .

Press

After ID information is entered and development mode is selected, press to advance to
the next screen.

If Virena has been configured, the User will advance to the Patient Information screen
where additional patient information may be entered.

If Age Required has been set to Yes, the User will be asked to enter the patient’s age before
advancing. Refer to the Virena Settings section on page 23 for more information.

Press to advance to the next screen and gently pull open the Sofia 2 drawer.

Insert the Test Cassette into the drawer and gently close the drawer (Figure 27).

Figure 27

Upon closing the drawer, Sofia 2 will start automatically and display the progress on the
screen.

Note: If Virena is not configured, the User will advance directly to the insert cassette
screen after pressing .

Page 38 of 51

Patient Test Results

When the test is complete, the results for both the patient specimen test(s) and 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 or transmitted to the LIS.

The results may be also be printed on an attached printer by selecting .

Refer to the assay-specific Package Insert for details on how to interpret results for
specific tests.

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 28).

Note: Once results have been generated for an individual Test Cassette, Sofia 2 will no
longer accept that Cassette a second time.

Page 39 of 51

Figure 28

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 can locate QC result details in the same manner as Patient Test Results (Figure 29).

Figure 29

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 30).

Page 40 of 51

Figure 30

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.

A list of the Kit/Lots that have been processed by the QC procedure will be displayed along
with the expiration date.

Select to return to the Run Test screen.

View Assay Methods

A list of the installed Assay Methods and Version number loaded is displayed.
Select to return to the Run Test screen.

Note: Results can be reprinted from the Review Data screen by pressing on Sofia 2’s with
Firmware 1.13.4 or higher.

Run QC

Page 41 of 51

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.

QC Results

Once the QC run is complete, the system will display either a valid result, , or an invalid
result, .

Select to complete the 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.

Run Calibration

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.

Note: When running Positive and Negative controls with a qualitative test, the Positive
Control must be tested first before the Negative Control.

Page 42 of 51

Following the prompts, insert the Calibration Cassette into Sofia 2 and gently close the
drawer. Sofia 2 will perform the Calibration Check automatically.

Select to return to the Run Test screen after Calibration is completed.

Caution: Store the Calibration Cassette in the provided storage pouch at room
temperature (15°C to 30°C) between uses. Improper storage could damage the
Calibration Cassette, which may lead to a failed Sofia 2 Calibration Check. Do
not touch the read window of the Calibration Cassette as this may impact the
results.

Calibration Results

Sofia 2 displays results as either or indicating that the Calibration Check is completed.

The Calibration results are stored and can be recalled with the Review Calibration Results
function of Sofia 2 from the Review Data menu (page 36).

Send Data

For Send Data, the following options will be displayed on the screen:

◼ Last Result
◼ All Results
◼ Test Connection

To manually send data to Virena, select one of the options above then press . If data was
sent successfully, will appear on the screen. If data was not sent successfully, the
message Send To Virena Error will appear. Confirm Virena configuration and re-attempt to
send data. If unsuccessful after a second attempt, contact Technical Support.

To manually send data to the LIS, select one of the options above then press . If data was
sent successfully, will appear on the screen. If data was not sent successfully, the

Note: If Calibration Check does not complete successfully, notify the on-site Supervisor,
or contact Quidel Technical Support for assistance at 800.874.1517 (in the U.S.). See page
3 for additional contact information.

Page 43 of 51

message Send To LIS Error will appear. Confirm configuration and re-attempt to send data.
If unsuccessful after a second attempt, contact Technical Support.

Shutdown

Turn off the unit by holding the power switch in the rear of the unit. The shutdown is
complete when the screen goes dark.

Maintenance and Cleaning

Maintenance

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.

To optimize instrument performance and charging, it is recommended that the battery
remain installed in the instrument.

Before 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 30).

Attach the new battery and replace the battery cover. Recycle or dispose of the lithium
battery in accordance with all Federal, State, and Local laws. To avoid fire and explosion
hazards, do not burn or incinerate the battery. Batteries shall not be disposed of with
municipal waste.

Sofia 2 Storage

If the Sofia 2 is intended to be stored and/or not used for an extended period of time (> 3
months), unplug the unit from AC power and remove the battery (Figure 31). When ready
to use the Sofia 2 again, install the battery and follow the Installation, Setup, and Operation
section of this User Manual.

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 44 of 51

Figure 31

Cleaning

To reduce the risk of electrical shock:

◼ Do not disassemble Sofia 2. Sofia 2 contains no user-serviceable components.
◼ Possible electrical shock: Turn off and unplug Sofia 2 before 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 the exterior of Sofia 2. Do not use soap or other solutions except
those noted below. Wipe the external surfaces and cassette drawer only.

Removing the Drawer for Cleaning

Ensure that there is no cassette in the drawer and unplug Sofia 2. Gently pull the drawer out
until it stops, then lift up Sofia 2 and press the button as shown (Figure 32). The drawer can
then be removed.

Note: The following disinfectants identified in EPA’s list of disinfectants for use against
Ebola virus have been found by Quidel to be compatible for use with Sofia 2:

• Clorox Healthcare; Bleach Germicidal Cleaner (EPA Reg #: 56392-7)

• Clorox Commercial Solutions; Clean-Up Disinfectant Cleaner with Bleach 1 (EPA

Reg #: 67619-17)

• Clorox Healthcare; Bleach Germicidal Wipes (EPA Reg #: 67619-12)

Note: If resistance is met, do not force. Apply slightly more pressure to release the catch.

Page 45 of 51

Figure 32

Use a soft cloth with 70% alcohol or 0.6% bleach solution to clean the drawer only. DO NOT
clean the interior of Sofia 2. DO NOT submerge drawer in cleaning solution.

After cleaning the drawer, insert it carefully aligning the rails of the drawer into the tracks of
Sofia 2 (Figure 33).

Figure 33

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 46 of 51

Appendices

Appendix A Technical Specifications

Sofia 2

Dimensions

22 cm deep x 12 cm wide x 12 cm high

Weight

2 lbs (1 kg)

Power Supply Input

100-240 VAC, 50/60 Hz, self-switching
(U.S./International), 2.93 Amp maximum

Sofia 2 Input

7.5V DC 2.5A

Replaceable Battery

LiPo rechargeable battery

Display

4-inch color LCD touchscreen

LAN Interface

RJ45 connector

Operating Temperature

15°C to 30°C / 59°F to 86°F

Operating Humidity

20% to 85% RH non-condensing

Operating Altitude

2000 m maximum

Shipping and Storage

Temperature

–20°C to 55°C

Shipping and Storage Humidity

20% to 85% RH non-condensing

Patient Test Result Storage

1,000 tests maximum

QC Results Storage

200 results maximum

Calibration Results Storage

200 results maximum

User Storage

1000 users maximum

Page 47 of 51

The following barcodes have been configured at the time of shipment:

1D Barcodes:

◼ UPC-A

◼ CODE 39

◼ UPC-E

◼ CODE 93 AND 93i

◼ EAN – 13 WITH EXTENDED COUPON CODE

◼ CODE 128

◼ CODABAR

◼ GS1 DATABAR

◼ INTERLEAVED 2 OF 5

2D Barcodes:

◼ DATA MATRIX

◼ AZTEC CODE

◼ QR CODE

Appendix B Optimizing Analyzer Placement

◼ Do not stack the analyzers.
◼ Do not place the analyzer near a heat source.
◼ Allow for the spacing of a minimum of 6 inches between Sofia 2 analyzers.
◼ Do not place the analyzer near a wall or other surface that minimizes proper

ventilation including the area behind the unit.

Appendix C System Troubleshooting

Error Messages

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.

ID

Displayed Text

Action

1

Unexpected error.

Contact Technical Support.

2

User ID must be entered.

Enter a valid User ID to proceed.

3

Patient ID must be entered.

Enter a Patient ID to proceed.

4

Invalid User ID.

Enter a valid User ID to proceed.

5

Removable storage is missing or not
writable. Please insert a USB storage
device and try again.

Insert a USB flash drive.

Page 48 of 51

ID

Displayed Text

Action

6

Kit Lot ID must be entered.

Enter the Kit Lot number.

7

File write failed.

Replace USB flash drive.

8

Current temperature out of range of
assay or system.

The temperature range allowed is 15°C
to 30°C / 59°F to 86°F.

9

Printing error.

Check connection to printer.

10

Invalid QC Card barcode.

Check or rescan QC Card.

11

Printer not found.

Check connection to printer.

12

Unreadable Cassette barcode.

Ensure Cassette is inserted properly and
there are no markings on the barcode.

13

Cassette not valid for current test.

Retest using a Cassette of the correct
device type.

14

Assay Method File unavailable for
supplied Cassette.

Only test with approved Sofia 2 assays.

15

Cassette cannot be reused.

Use a Test Cassette that has not been
previously run.

16

Cassette drawer is open, unable to read
barcode.

Close drawer to proceed with the test.
17

Barcode scanning in progress.

Wait until the barcode scan is complete.

18

Cassette is past the expiration date.
Please retest with a non-expired
Cassette.

Retest with a non-expired Cassette.

19

Calibration period has expired and the
instrument is locked until Calibration
has been successfully completed.

Calibrate Sofia 2.
20

Cassette barcode is invalid, missing or
unreadable.

Retest using a Cassette with a valid
barcode.

21

Data could not be successfully
exported.

Confirm correct USB flash drive was
used and inserted correctly.

22

Data could not be successfully
imported.

Confirm correct USB flash drive was
used and inserted correctly.

23

User ID already exists.

Choose another User ID.

24

QC Card is past the expiration date.

Retest with a non-expired QC Card.

25

There was an error performing the
upgrade. Please reboot and try again.

Confirm correct USB flash drive was
used and inserted correctly.

26

User Name contains invalid characters.

Enter a User Name containing 20
characters or less.

27

Language file could not be successfully
loaded.

Confirm correct USB flash drive was
used and inserted correctly.

28

Loading Assay Method failed.

Confirm correct USB flash drive was
used and inserted correctly.

29

Log file could not be successfully
exported.

Confirm correct USB flash drive was
used and inserted correctly.

Page 49 of 51

ID

Displayed Text

Action

30

Battery is low. Please plug in to AC
power before running another test.

Connect Sofia 2 to AC power or charge
battery before running another test.

31

Calibration Failed.

Contact Technical Support.

32

Power On Self-Test error.

Clean the drawer, including the two
chips located on either side of the
drawer, re-boot the instrument, and
retry.
If not corrected, discontinue use and
contact Technical Support.

33

Supervisor ID should have between 4­12 characters.

Check Supervisor ID and re-enter.

34

Last Supervisor cannot be changed.

Create a replacement Supervisor or set
a new default Supervisor before
changing User status.

35

Stray light or wrong Calibration.

Restart Sofia 2 and if the issue
continues, contact Technical Support.

36

Invalid Operator Number.

Enter a valid Operator number (i.e., is
not a duplicate or longer than 20 digits).

37

Logged-in User cannot be deleted.

Log out User and log in as another User
before deleting.

38

Logged-in User cannot be changed to
an Operator.

Log out User before changing User
status.

39

Mains power must be supplied to
upgrade. Please plug in to AC power
and try again.

Connect Sofia 2 to AC power before
upgrading firmware.

40

USB storage device does not contain a
valid upgrade file.

Ensure that the correct firmware
upgrade file has been downloaded from
myquidel.com.

41

There was an error performing the
upgrade. Please reboot and try again.

Confirm correct USB flash drive was
used and inserted correctly.

42

Removable storage is missing. Please
insert a USB storage device with the
upgrade file and try again.

Confirm correct USB flash drive was
used and inserted correctly.

43

User ID and Operator Number must not
match.

Enter a PIN that is different from the
Operator Number.

44

User rights are insufficient for this
function.

Log in as a Supervisor to access this
function.

45

Test connection error.

Contact Technical Support.

46

Unable to apply settings changes,
previous values retained.

Return to Settings screen an attempt to
apply changes again.

47

Send to Virena error.

Contact Technical Support.

48

Invalid age.

Enter an age between 1-129.

Page 50 of 51

ID

Displayed Text

Action

49

Invalid study code.

Enter a study code containing 1-2
numeric characters.

50

Send to Virena error. Battery is faulty.

Contact Technical Support.

51

Restore factory defaults error.

Contact Technical Support.

52

The operation failed to produce a
result.

Contact Technical Support.

53

USB storage device does not contain
Assay Methods.

Ensure that the correct Assay Method
File has been downloaded from
myquidel.com.

54

Some files were not imported
successfully.

Ensure that correct files have been
downloaded from myquidel.com.

Quidel, Sofia and Virena are registered trademarks of Quidel Corporation. Any other trademark
contained in this document is the property of its respective owner and its use herein does not imply
sponsorship or endorsement of any products or services.

20299 – Sofia 2 (US)
20300 – Sofia 2 (OUS)

MDSS GmbH
Schiffgraben 41
30175 Hannover,
Germany

Quidel Corporation

10165 McKellar Court
San Diego, CA 92121 USA

quidel.com

Page 51 of 51

For EU only
Quidel Ireland Ltd.
2nd Floor, Merchants Square
Merchants Road
Galway, Ireland H91 ETN2
[e-mail]

Revision Changes:

▪ Updated Quidel contact information for customer assistance
▪ Added label symbols:

o CE mark of conformity
o Batch code
o Date of manufacture
o Use-by date
o Importer
o Do not re-use
o China RoHS
o Patient number
o Control
o Prescription use only in the United States
o Biological risks
o Device for near patient testing
o Device not for self testing

▪ Added the following instructions to the Brief Warnings section:

o For in-vitro diagnostic use.
o For professional and near patient testing.
o For use by healthcare professionals.
o Do not immerse the Sofia 2 in water or any liquids.

▪ Added EU Importer information and address

1317808EN00 (03/22)