Quidel Sofia User manual

Page 0of 57
User Manual

Page 1of 57
Table of Contents
General Information ...........................................................................................................................4
Quidel Contact Information.............................................................................................................4
Main Menu Structure –v.2.0 or higher ...........................................................................................5
Supervisor Menu Structure –v.2.0 or higher ..................................................................................6
Main Menu Structure –previous to v.2.0 .......................................................................................7
Supervisor Menu Structure –previous to v.2.0...............................................................................8
Labels and Symbols..........................................................................................................................9
Brief Warnings, Precautions and Limitations ................................................................................10
Safety Precautions .........................................................................................................................10
Introduction.......................................................................................................................................12
Intended Use..................................................................................................................................12
Product Description .......................................................................................................................12
Calibration Check and Quality Control (QC) ..................................................................................12
Development Modes .....................................................................................................................12
System Components......................................................................................................................13
Sofia ...........................................................................................................................................13
Installation Pack.........................................................................................................................14
User Types .....................................................................................................................................14
System Display and Keypad..............................................................................................................15
System Display...............................................................................................................................15
System Keypad...............................................................................................................................15
System User Interface....................................................................................................................16
Installation, Setup and Operation....................................................................................................17
Sofia Setup .....................................................................................................................................17
Sofia Setup .................................................................................................................................17
Loading Paper ............................................................................................................................18
Power Up .......................................................................................................................................19
Cassette Drawers...........................................................................................................................20
System Settings..............................................................................................................................22
Logging in as Supervisor ............................................................................................................22
Set Default Mode and Print Options .........................................................................................22
Set Entry Requirement and Timeout.........................................................................................23
Set Calibration and QC...............................................................................................................24
Set User Access Rights ...............................................................................................................24
General Sofia Settings....................................................................................................................24
Set Location Name.....................................................................................................................24
Set Language and Sound............................................................................................................25
Set Date......................................................................................................................................25
Set Time .....................................................................................................................................26
Load Test Types .............................................................................................................................26
Load Test Types from SD Card ...................................................................................................26
Load Test Types From Cloud......................................................................................................26
Test Cloud Connection...............................................................................................................27
Managing Users .............................................................................................................................27
Add User ....................................................................................................................................27
Edit User.....................................................................................................................................28

Page 2of 57
Delete User ................................................................................................................................28
Review Data ...................................................................................................................................29
Review Patient Results ..............................................................................................................29
Review QC Results .....................................................................................................................29
Review Calibration Results ........................................................................................................30
View Lot Status ..........................................................................................................................30
View Test Types .........................................................................................................................30
Sofia Statistics................................................................................................................................30
View Analyzer Info.....................................................................................................................31
View User History ......................................................................................................................31
View Message Log .....................................................................................................................31
Load/Save ......................................................................................................................................31
Save Settings to SD Card............................................................................................................31
Load Settings From SD Card.......................................................................................................32
Save Test Records to SD Card ....................................................................................................32
Update ...........................................................................................................................................32
Load Sofia Firmware ..................................................................................................................32
Load Firmware from SD Card.....................................................................................................33
Load Firmware from Cloud ........................................................................................................33
Test Cloud Connection...............................................................................................................33
Load Language File.....................................................................................................................33
Load Language File from SD Card ..............................................................................................34
Load Language File from Cloud .................................................................................................34
Test Cloud Connection...............................................................................................................34
Calibration Check...........................................................................................................................34
Perform Sofia Calibration Check................................................................................................35
Calibration Results.....................................................................................................................35
Run QC ...........................................................................................................................................35
QC Results..................................................................................................................................36
Run Patient Specimens ..................................................................................................................36
Change Development Mode..........................................................................................................37
Enter the User ID .......................................................................................................................37
Enter the Patient ID ...................................................................................................................37
Enter the Order #, if applicable .................................................................................................38
Test Procedure...........................................................................................................................38
Press START Test........................................................................................................................38
Patient Test Results ...................................................................................................................38
Network Configuration ..................................................................................................................39
Update Settings .............................................................................................................................40
Laboratory Information System (LIS).............................................................................................41
LIS Parameters and Settings ......................................................................................................41
Send Results to LIS.........................................................................................................................42
Surveillance Mode .........................................................................................................................42
Sofia and Virena Router Connection Installation ......................................................................43
Set Network Configuration ........................................................................................................43
Surveillance Mode Set Up..........................................................................................................43
Virena Router Connection Verification..........................................................................................44
Performing Tests in Surveillance Mode.....................................................................................46
Send Results to SURV Receiver..................................................................................................46

Page 3of 57
Shutdown.......................................................................................................................................47
Maintenance and Cleaning............................................................................................................47
Maintenance..............................................................................................................................47
Battery Power ............................................................................................................................47
Cleaning .....................................................................................................................................48
Appendices........................................................................................................................................51
Appendix A Technical Specifications .............................................................................................51
Sofia ...........................................................................................................................................51
Barcode Scanner........................................................................................................................51
Appendix B System Troubleshooting.............................................................................................52
Error Messages ..........................................................................................................................53
Index ..................................................................................................................................................55

Page 4of 57
General Information
Quidel Contact Information
Contact Quidel Technical Support from 7:00 a.m. to 5:00 p.m. PST.
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

Page 5of 57
Main Menu Structure –v.2.0 or higher

Page 6of 57
Supervisor Menu Structure –v.2.0 or higher

Page 7of 57
Main Menu Structure –previous to v.2.0

Page 8of 57
Supervisor Menu Structure –previous to v.2.0

Page 9of 57
Labels and Symbols
Label
Description
Manufacturer
In vitro diagnostic medical device
Prescription use only
Consult instructions for use
Authorized representative in the European Community
Temperature limitation
Directive 2002/06/EC on waste electrical and electronic equipment (WEEE)
SD Card
Serial Number
Catalog Number
Symbol
Description
Warning!
Indicates a hazardous situation, which if not avoided, could result in injury to
the Operator or a bystander (e.g., electrical shock or UV exposure).
Potential Biohazard!
An agent of biological origin that has the capacity to produce deleterious
effects on humans, i.e. microorganisms, toxins, and allergens derived from
those organisms; and allergens and toxins derived from higher plants and
animals.

Page 10 of 57
Caution!
Indicates a situation, which if not avoided could result in damage to the device
or incorrect results.
Laser Radiation!
Do not stare into beam.
Brief Warnings, Precautions and Limitations
Always operate Sofia on a surface that is level and dry and not in direct sunlight.
The Sofia Calibration Cassette is sensitive to light. Store it in the opaque sleeve it was
shipped in whenever it is not being used.
Never move Sofia while there is a test in progress.
Use only the power adapter that was provided with Sofia.
Do not drop Sofia as it could damage the unit.
To avoid damaging Sofia, never place objects on top of it.
Safety Precautions
Sofia is designed to provide safe and reliable operation when used according to this User Manual.
If Sofia 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 before cleaning.
Plug the device into an approved receptacle.
Do not immerse in water or cleaning solutions.
Do not attempt to open the enclosure.
Use the appropriate power cord for the region.
Laser Radiation!
To reduce the risk of UV Exposure:
Do not attempt to open or disassemble Sofia.
Failure to follow these warnings will invalidate the warranty.

Page 11 of 57
Potential Biohazard!
To reduce the risk of biohazard:
Dispose of used specimens in accordance with Federal, State and Local requirements.
Treat specimens and patient samples as potentially biohazardous material.
Ensure Sofia is cleaned per the Maintenance and Cleaning section prior to storage,
transport or disposal.
Seek specific training or guidance if you are not experienced with specimen collection and
handling procedures.
Use of Nitrile, Latex, or other gloves is recommended when handling patient samples.
Caution!
To reduce the risk of incorrect results:
Sofia should only be used by trained operators.
Do not use if Sofia 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 dating.
To reduce the risk of Sofia damage:
Sofia is designed for counter top operation under laboratory conditions.
Sofia is not designed to withstand moisture, extreme humidity, or extreme temperatures.
Sofia 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. See page
4 for additional contact information.
Clean Sofia per the Maintenance and Cleaning section of this User Manual prior to return
or disposal.
Note: Always dispose of Sofia and accessories in accordance with Federal, State and Local
requirements.

Page 12 of 57
Introduction
Intended Use
Sofia is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro
diagnostic assays manufactured by Quidel Corporation. Sofia is intended for professional and
laboratory use.
After the patient sample has been added to the Test Cassette, depending upon the assay and/or
the user’s choice, the Cassette is either placed inside of Sofia 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 to be scanned (READ NOW Mode). Sofia will scan the test
strip and measure the fluorescent signal by processing the results using method-specific
algorithms. Sofia will display the test results.
Refer to assay-specific Package Insert for details on specific tests.
Product Description
Sofia 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 scanned. This ensures that sample flow has
occurred within the Cassette to permit an accurate reading.
Sofia then displays the test results to the User (e.g., Quantitative, Qualitative, or Invalid) on the
screen. The results can also be automatically printed on an integrated printer if this option is
selected, saved on an SD Card and sent to an LIS if connected.
Calibration Check and Quality Control (QC)
Sofia Calibration Check and external Quality Control Tests must be performed on a periodic basis.
Sofia Calibration Check: Calibration Check is a required function that checks the internal
Sofia optics and systems. A Calibration Check must be performed every 30 days or less, as
set by the supervisor. A special Calibration Cassette is provided with the Installation Pack.
External Quality Controls: Refer to assay-specific Package Insert for details on specific
tests.
Instructions are provided in the Calibration Check and Run QC sections.
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.

Page 13 of 57
The correct development time is required to get accurate results.
Sofia has been designed to operate in different development modes. The Supervisor and User can
identify the mode that works best with the 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 has the capability of three different WALK
AWAY Modes: User selected WALK AWAY Mode, Locked WALK AWAY Mode and Forced WALK
AWAY Mode.
User Selected WALK AWAY Mode may be 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 Cassette and then immediately inserts the Cassette
into Sofia. Sofia will automatically allow the Cassette to develop for the required time
period (pre-programmed for each test), scan the Cassette, analyze and interpret the data,
and automatically and objectively display the test result.
Locked WALK AWAY Mode can only be selected while logged in as a Supervisor. In this
mode Sofia 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.
Forced WALK AWAY Mode is used with certain Sofia assays. Please refer to appropriate
assay-specific Package Insert for information regarding this mode. In this mode Sofia will
automatically develop the Cassette for the required time period (pre-programmed for
each test), scan the Cassette, and display the test result when completed. READ NOW
development timing will not be available for some assays that require Forced WALK AWAY
Mode.
READ NOW Mode may be most convenient for high volume situations as Sofia can quickly read
multiple patient samples sequentially. The User dispenses the patient sample into the Cassette.
The User then manually times the development period outside of Sofia. 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 Cassette into
Sofia. Sofia will immediately scan and display the test result within 1 minute.
System Components
Inspect the shipping container for obvious shipping damage prior to opening. Unpack the shipping
container and inspect the unit and components for damage.
The following system components are supplied with the purchase of each Sofia:
Sofia
Sofia with integrated printer
Printer Paper
Batteries 4x LR6-AA + 6V, ===4.26 A
AC Power Cord
DC Power Cord
Specific Country Adapter(s)

Page 14 of 57
Installation Pack
User Manual
QuickStart Guide
Warranty Card
Barcode Scanner
Barcode Scanner Stand
SD Card(s) –Test Type Files (Blue), Language Files (Yellow),* and Blank SD Card
Calibration Cassette
For components supplied with Virena, refer to the Sofia Surveillance Mode Installation
Instructions.
Contact Quidel Technical Support for additional supplies at 800.874.1517 (in the U.S.). See page 4
for additional contact information.
Sofia consumable test kits, including Test Cassettes and External Quality Control materials, are
shipped separately.
Consult your Quidel representative for a listing of approved Sofia assays.
*Language Files (Yellow) may not be provided in the Installation Pack. If needed, contact Quidel
Technical Support.
User Types
Users/Operators without Supervisor authorization have access to the following functions:
User/
Operator
Power on Sofia
Perform Calibration
Run QC (External Controls)
Run Test With Patient Samples
Review Data (Calibration and QC)
Instructions for these basic User functions are provided in the Basic User Instructions section.
Operators with Supervisor authorization access can perform all of the following functions:
Supervisor
(Must have a valid log-in
to access supervisor menu.)
Load Test Types
Add or Delete Users
Load and Save Settings
Save Test Records
Update Sofia Firmware
Load Languages
View User History
View Message Logs
Review Patient Results
Review Statistics
Change Settings

Page 15 of 57
System Display and Keypad
System Display
The Sofia contains a 3.5 inch diagonal color LCD display for interacting with the user interface.
System Keypad
The User Interface includes a numeric keypad and other function specific buttons (Table 1 and
Figure 1).
Table 1
Keypad Description
Button Icon
Button Name
Function
Example of Use
Numeric Keypad
Enter numeric data
Entering a date and
time or IDs
Backspace
Backspace to delete data
Delete the character to
the left of the cursor
Decimal Point
Decimal Point
IP Addresses
Up/Down/Left/Right
Navigate the User
Interface
Selecting a field
Eject
Eject a Cassette
Interrupting testing
Soft Keys
Select menu options
shown on the screen
above each key
Select OK on the “Enter
or Scan” screen
Paper Feed
Paper Feed
Loading paper into Sofia
Print
Manual print
Printing previous results

Page 16 of 57
Figure 1
System User Interface
Screen Icon
Description
Indicates Sofia is in the WALK AWAY Mode.
There is an SD Card inserted in the slot.
Indicates Sofia is in the READ NOW Mode.
Indicates the Supervisor is currently logged into
Sofia.

Page 17 of 57
Installation, Setup and Operation
Sofia Setup
Sofia Setup
Place Sofia on the bench top within reach of an electrical outlet. The unit is portable and
can be moved to a suitable location for testing. Ensure counter top is stable, flat and dry.
Avoid direct sunlight.
Ensure the bench provides adequate space for Sofia and barcode scanner stand. There
must be space to open/close Sofia drawer and access the connection ports on the back of
the unit.
Plug the DC power cord into the power port in the back of Sofia. Plug the country specific
AC adapter power cord into the DC power cord and an available electrical outlet.
Plug the Barcode Scanner into the PS2 port in the back of Sofia (Figure 2).
Figure 2
SD Card –Proper insertion should follow the diagram label on Sofia. The SD Card should be
inserted with the copper contact points facing away from the power switch with the
notched corner facing down as shown (Figure 3). Virena Router
Note: For Virena Router set-up, please refer to the Sofia Surveillance Mode Installation
Instructions that are supplied in the separate Virena Router package.

Page 18 of 57
Figure 3
Loading Paper
Load paper into the integrated printer of Sofia (Figure 4).
Lift black handle to remove paper cover.
Place paper roll in Sofia with the paper tail coming from under the roll towards the
operator.
Holding the paper tail towards the operator, replace the paper cover and snap in place.
Figure 4 Roller Bar
Note: The paper does not need to be fed through the roller bar.
Note: If the roller bar disconnects from paper cover, snap into place with gear on the left
(Figure 4).

Page 19 of 57
Power Up
Turn Sofia on using the power switch located on the rear panel (Figure 5). Hold the toggle switch
down for 1-2 seconds until the screen illuminates.
Figure 5
Sofia will display the Power On progress screen and complete a Power On Self-Test. The Barcode
Scanner will chirp upon powering up. Once the Power On is complete, Sofia will display the Start
Test screen (Figure 6) and Sofia is ready for use.
Figure 6
When turning on Sofia for the first time, the Checking Internal Reference screen will display
(Figure 7). Depending on which drawer is installed, the Internal Reference State may not be
available. If this is the case, it is acceptable to continue testing.