Quidel Lyme FIA Sofia 2 User manual

User Manual

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Table of Contents
General Information ......................................................................................................................... 3
Quidel Contact Information.......................................................................................................... 3
Main Menu Structure................................................................................................................... 4
Labels and Symbols ...................................................................................................................... 5
Icons............................................................................................................................................. 6
Brief Warnings, Precautions, and Limitations............................................................................... 8
Safety Precautions........................................................................................................................ 8
Introduction.................................................................................................................................... 11
Intended Use.............................................................................................................................. 11
Product Description.................................................................................................................... 11
Calibration Check and Quality Control (QC) ............................................................................... 11
Development Modes.................................................................................................................. 12
System Components................................................................................................................... 12
Sofia 2 ................................................................................................................................. 12
Additional Ancillaries (optional).......................................................................................... 12
User Types.................................................................................................................................. 13
System Display................................................................................................................................ 14
System Display ........................................................................................................................... 14
Installation, Setup, and Operation.................................................................................................. 15
Sofia 2 Setup .............................................................................................................................. 15
Power Up.................................................................................................................................... 15
Calibration Check ....................................................................................................................... 18
Supervisor Menu ........................................................................................................................ 18
Logging in as Supervisor...................................................................................................... 18
Settings ............................................................................................................................... 18
Set Entry Requirements ...................................................................................................... 19
Set Default Mode and Timeout........................................................................................... 19
Calibration and QC.............................................................................................................. 19
Data Security....................................................................................................................... 19
Other Settings..................................................................................................................... 20
Network Settings........................................................................................................................ 21
Network Interface............................................................................................................... 21
LIS Settings.......................................................................................................................... 22
Virena Settings.................................................................................................................... 23
Test Virena Connection....................................................................................................... 24
Connect to Quidel ............................................................................................................... 25
Software Updates ............................................................................................................... 26
Statistics ..................................................................................................................................... 27
View Analyzer Info .............................................................................................................. 27
View Message Log............................................................................................................... 28
Managing Users.......................................................................................................................... 29
Add User ............................................................................................................................. 29
Edit User ............................................................................................................................. 30
Delete User ......................................................................................................................... 30
Export, Import, Delete................................................................................................................ 31
Export, Import, or Delete Data Types.................................................................................. 31
Export Settings to USB Flash Drive...................................................................................... 31
Import Settings from USB Flash Drive................................................................................. 32

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Export Patient Data to USB Flash Drive............................................................................... 32
Sofia 2 Firmware and Assay Methods ................................................................................. 32
Import Firmware from USB Flash Drive............................................................................... 32
Import Assay Methods from USB Flash Drive...................................................................... 33
Import Language Files from USB Flash Drive....................................................................... 33
Run Test (Patient Specimens)..................................................................................................... 33
Enter the User ID................................................................................................................. 33
Enter the Patient ID ............................................................................................................ 34
Enter the Order Number, if applicable................................................................................ 34
Change Development Mode ............................................................................................... 34
Test Procedure.................................................................................................................... 35
Press ................................................................................................................................ 35
Patient Test Results............................................................................................................. 36
Review Data ............................................................................................................................... 36
Review Patient Results........................................................................................................ 36
Review QC Results............................................................................................................... 37
Review Calibration Results.................................................................................................. 37
View Lot Status ................................................................................................................... 38
View Assay Methods........................................................................................................... 38
Run QC ....................................................................................................................................... 38
QC Results........................................................................................................................... 39
Run Calibration........................................................................................................................... 39
Perform Sofia 2 Calibration Check ...................................................................................... 39
Calibration Results .............................................................................................................. 40
Send Data................................................................................................................................... 40
Shutdown................................................................................................................................... 41
Maintenance and Cleaning......................................................................................................... 41
Maintenance....................................................................................................................... 41
Battery Power ..................................................................................................................... 41
Sofia 2 Storage................................................................................................................................ 41
Cleaning .............................................................................................................................. 42
Appendices ..................................................................................................................................... 44
Appendix A Technical Specifications .......................................................................................... 44
Sofia 2 ................................................................................................................................. 44
Appendix B Optimizing Analyzer Placement............................................................................... 45
Appendix C System Troubleshooting.......................................................................................... 45
Error Messages ................................................................................................................... 45

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General Information
Quidel Contact Information
Contact Quidel Technical Support from 7:00 a.m. to 5:00 p.m. Pacific Time
Tel: [phone] (in the U.S.);
858.552.1100 (outside the U.S.)
Fax: [phone]
E-mail: [email protected] or contact your local distributor
Website: quidel.com

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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

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Icons

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Brief Warnings, Precautions, and Limitations
◼Always operate Sofia 2 on a surface that is level, dry, and not in direct sunlight.
◼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.
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.
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).

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◼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.
◼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.

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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.

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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 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.
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.