Quidel Sofia User Manual

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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

Quidel Sofia Specifications

General

Detection Method	Fluorescence
Result Time	15 minutes
Humidity	10-90% non-condensing
Assay Type	Immunoassay
Storage Temperature	2°C to 30°C
Product Type	Point-of-Care Diagnostic
Technology	Fluorescence Immunoassay
Connectivity	USB
Operating Temperature	15-30°C
Reportable Range	Qualitative (Positive/Negative)