Product Manual

Page 1 of 41
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) ................................................................................................ 12
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
Set Entry Requirements ............................................................................................................. 16
Set Default Mode and Timeout ................................................................................................. 16
Calibration and QC ..................................................................................................................... 16
Data Security .............................................................................................................................. 16
Other Settings ............................................................................................................................ 17
Network Settings ........................................................................................................................... 18
Virena Settings ........................................................................................................................... 18
Test Virena Connection ............................................................................................................. 20
Statistics ......................................................................................................................................... 20
View Analyzer Info ..................................................................................................................... 20
View Message Log ..................................................................................................................... 21
Managing Users ............................................................................................................................. 22
Add User .................................................................................................................................... 22
Edit User ..................................................................................................................................... 23
Delete User ................................................................................................................................ 23
Export, Import, Delete ................................................................................................................... 24
Export, Import or Delete Data Types ......................................................................................... 24
Export Settings to USB Flash Drive ............................................................................................ 25
Import Settings from USB Flash Drive ....................................................................................... 25
Sofia 2 Firmware and Assay Methods ....................................................................................... 25
Import Firmware from USB Flash Drive ..................................................................................... 26
Import Assay Methods from USB Flash Drive............................................................................ 26
Run Test (Patient Specimens) ........................................................................................................ 26
Enter the User ID ....................................................................................................................... 26