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.