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.