Quidel Lyme FIA Sofia 2 User manual

User Manual

Page 1 of 40
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

Page 2 of 40
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

Page 3 of 40
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

Page 4 of 40
Main Menu Structure

Page 5 of 40
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

Page 6 of 40
Icons

Page 7 of 40

Page 8 of 40
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.

Page 9 of 40
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.