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.......................................................................................................................................10
Intended Use..................................................................................................................................10
Product Description.......................................................................................................................10
Calibration Check and Quality Control (QC) ..................................................................................10
Development Modes .....................................................................................................................11
System Components......................................................................................................................11
Sofia 2 ........................................................................................................................................11
Additional Ancillaries (optional) ................................................................................................11
User Types .....................................................................................................................................12
System Display...................................................................................................................................13
System Display...............................................................................................................................13
Installation, Setup and Operation .....................................................................................................13
Sofia 2 Setup ..................................................................................................................................13
Power Up .......................................................................................................................................14
Supervisor Menu............................................................................................................................15
Logging in as Supervisor ............................................................................................................15
Settings ......................................................................................................................................15
Calibration and QC.....................................................................................................................16
Data Security..............................................................................................................................16
Other Settings............................................................................................................................16
Network Settings ...........................................................................................................................17
Virena Settings...........................................................................................................................17
Test Virena Connection .............................................................................................................19
Statistics.........................................................................................................................................20
View Analyzer Info.....................................................................................................................20
View Message Log .....................................................................................................................21
Managing Users .............................................................................................................................21
Add User ....................................................................................................................................22
Edit User.....................................................................................................................................22
Delete User ................................................................................................................................23
Export, Import, Delete ...................................................................................................................24
Export, Import, or Delete Data Types........................................................................................24
Export Settings to USB Flash Drive ............................................................................................24
Import Settings from USB Flash Drive .......................................................................................25
Export Test Records & Logs to USB Flash Drive.........................................................................25
Sofia 2 Firmware........................................................................................................................25
Import Firmware from USB Flash Drive.....................................................................................25
Run Test (Patient Specimens)........................................................................................................26
Enter the User ID .......................................................................................................................26
Enter the Patient ID ...................................................................................................................26

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Enter the Order Number, if applicable ......................................................................................27
Change Development Mode......................................................................................................27
Test Procedure...........................................................................................................................27
Press .......................................................................................................................................27
Patient Test Results ...................................................................................................................28
Review Data...................................................................................................................................29
Review Patient Results ..............................................................................................................29
Review QC Results .....................................................................................................................29
Review Calibration Results ........................................................................................................30
View Lot Status ..........................................................................................................................30
View Test Types .........................................................................................................................30
Run QC ...........................................................................................................................................31
QC Results..................................................................................................................................31
Run Calibration ..............................................................................................................................31
Perform Sofia 2 Calibration Check.............................................................................................32
Calibration Results.....................................................................................................................32
Shutdown.......................................................................................................................................32
Maintenance and Cleaning............................................................................................................32
Maintenance..............................................................................................................................32
Battery Power ............................................................................................................................33
Cleaning .....................................................................................................................................33
Appendices ........................................................................................................................................36
Appendix A Technical Specifications .............................................................................................36
Sofia 2 ........................................................................................................................................36
Appendix B System Troubleshooting.............................................................................................37
Error Messages ..........................................................................................................................37

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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]
Email: [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
Prescription use only
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.
The Sofia 2 Calibration Cassette is sensitive to light. Store it in the opaque sleeve whenever
it is not being used.
Do not write on the barcode or surface of the cassette.
Never move Sofia 2 or open drawer while there is a test in progress.
Use only the Power Adapter that was provided with Sofia 2.
Do not drop Sofia 2 as it could damage the unit.
To avoid damaging Sofia 2, do not place objects on top of it.
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.
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.

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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 counter top operation.
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 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 on 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 bench top analyzer intended to be used with Cassette-based immunofluorescent in
vitro diagnostic assays manufactured by Quidel Corporation. Sofia 2 is intended for professional
and laboratory use.
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 bench top 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. 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.
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 bench top 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
QuickStart Guide
Calibration Cassette
Additional Ancillaries (optional)
Dymo Label Printer
Dymo Vinyl Label Roll
Dymo Paper Roll
Replacement Battery
Contact Quidel Technical Support for additional supplies at 800.874.1517 (in the U.S.). See page 3
for additional contact information.

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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)
Users with Supervisor authorization access can perform all of the following functions:
Supervisor
(Must have a valid log-in
to access Supervisor Menu.)
Add or Delete Users
Export and Import Settings
Export Test Records
Update Sofia 2 Firmware
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
Installation, Setup and Operation
Sofia 2 Setup
Place Sofia 2 on the bench top. The unit is portable and can be moved to a suitable
location for testing. Ensure counter top is stable, level, dry and free of obstructions.
Avoid direct sunlight.
Ensure the bench provides adequate space for Sofia 2. There must be space to
open/close the Sofia 2 drawer and access the connection ports on the back of the
unit.
Plug the Power Adapter into the power port on the back of Sofia 2. Then plug the
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 Indicator
Touchscreen Display
Cassette Drawer
Barcode Scanner

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Power Up
Turn Sofia 2 on using the power switch located on the rear panel (Figure 2).
Figure 2
Sofia 2 will display the Power On progress screen and complete a Power On Self-Test. Once
the Power On is complete, Sofia 2 will display the Run Test screen (Figure 3) and it is ready
for use.
Figure 3
When turning on Sofia 2 for the first time, a calibration check will be required (Figure 4). A
calibration check must be performed before using it for the first time. The default
Supervisor ID (1234) will be used for the calibration check.
Battery Compartment
Power Port
RJ45
USB Ports (2)
Power Switch

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Figure 4
Supervisor Menu
Logging in as Supervisor
The Supervisor Menu allows the Supervisor to access additional functionality and security
options depending on the work environment and the location of Sofia 2.
Settings
Entry to the Settings menu is accomplished by logging in as the Supervisor. Sofia 2 comes
from the manufacturer with a default Supervisor login ID which should be changed when
Sofia 2 is initially installed at the customer site. The default Supervisor ID is 1234.
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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Calibration and QC
Calibration Reminder
Using the touchscreen, enter the number of days for the Calibration reminder interval from
2-30. When the selected number of days remain until 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 touchscreen 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. Press to
confirm when changes are complete to return to the Run Test screen.
Other Settings
Set Site Name
The Site Name setting sets the name of the clinic, hospital, lab or physician’s office where
Sofia 2 is being used.
In the field for Site Name, use the touchscreen 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.
The Supervisor may also enter the 5-digit ZIP code using the touchscreen keypad.
When the Site Name and ZIP code are complete, continue to set Sound using .
Set Sound
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 Time and Date using .
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.

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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 confirm button 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 confirm button will not be available.
Press to confirm when changes are complete to return to the Run Test screen.
Network Settings
Virena Settings
To configure Virena, Virena Domain Name is pre-populated and no additional user input is
needed (Figure 5).
Figure 5

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Press to continue to the next screen. For Auto Send, select either On or Off. For Queue
Results, select either On or Off (Figure 6). Both settings must be set to On to send results to
the Virena cloud daily. 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 6
Press to continue to the next screen. For Transmit Patient ID, select either On or Off. For
Transmit Order Number, select either On or Off (Figure 7).
Figure 7
Press to continue to the next screen. For Age Required, select either On or Off (Figure 8).
If set to On, the User will need to enter the patient’s age prior to running each test.

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Figure 8
Select to confirm configuration and return to the Run Test screen.
Test Virena Connection
The final step of Virena configuration is to test the connection. This is accessed through the
Export, Import, Delete screen in the Supervisor Menu. To test the connection, use or in
the first field to select Test Connection. Then ensure that is selected and press to
begin the connection test (Figure 9). If successful, the on-screen pop-up will display Test
connection success. If unsuccessful, the on-screen pop-up will display Test connection
error. If the connection test is unsuccessful after a second attempt, please contact Quidel
Technical Support.
Figure 9