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Quidel Sofia User Manual

Quidel Sofia
58 pages
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User Manual

Table of Contents

Other manuals for Quidel Sofia

Questions and Answers:

Quidel Sofia Specifications

General IconGeneral
Detection MethodFluorescence
Result Time15 minutes
Humidity10-90% non-condensing
Assay TypeImmunoassay
Storage Temperature2°C to 30°C
Product TypePoint-of-Care Diagnostic
TechnologyFluorescence Immunoassay
ConnectivityUSB
Operating Temperature15-30°C
Reportable RangeQualitative (Positive/Negative)

Summary

General Information

Quidel Contact Information

Provides contact details for Quidel Technical Support, including phone, email, and website.

Labels and Symbols

Explains the meaning of various labels and symbols used on the Sofia device and its packaging.

Brief Warnings, Precautions and Limitations

Outlines essential warnings, precautions, and limitations for safe and proper use of the Sofia device.

Safety Precautions

Details specific safety measures to reduce risks of electrical shock, UV exposure, and biohazards.

Introduction

Intended Use

Describes the Sofia device's intended application as a benchtop analyzer for specific in vitro diagnostic assays.

Product Description

Details the Sofia's use of fluorescent tags, internal procedural controls, and result display capabilities.

Calibration Check and Quality Control (QC)

Explains the necessity and frequency of Calibration Checks and external Quality Control tests.

Development Modes

Discusses different development modes (WALK AWAY, READ NOW) for processing patient samples.

Installation Pack

User Types

Differentiates between User/Operator and Supervisor roles and their respective access levels.

System Display and Keypad

System Display

Details the Sofia's 3.5-inch diagonal color LCD display for user interaction.

System Keypad

Explains the numeric keypad and function buttons, including their icons, names, and uses.

System User Interface

Installation, Setup and Operation

Sofia Setup

Provides instructions for placing Sofia, ensuring adequate space, and connecting power and peripherals.

Loading Paper

Details the steps for loading paper into the integrated printer of the Sofia device.

Power Up

Guides the user on how to turn on the Sofia unit using the power switch and what to expect.

Cassette Drawers

Cassette Drawer Types

Describes the three types of cassette drawers available for Sofia and their compatibility with different assays.

Navigating the Menu Settings

Menu Navigation Controls

Explains how to use the Up/Down arrows and other keys to navigate menu options on the Sofia.

System Settings

Configuration Settings

Configures default modes, entry requirements, calibration/QC, and user access rights.

General Settings

Configures system-wide settings like location, language, sound, date, and time.

Load Test Types

Load Test Types from SD Card

Loads new Sofia test type files from an SD Card for assay recognition.

Load Test Types From Cloud

Loads new Sofia test type files from the Cloud, requiring Firmware 2.0 or higher.

Managing Users

Add User

Adds new users to the Sofia system, specifying ID, type (Operator/Supervisor), and name.

Edit User

Allows editing of existing user names and details within the Sofia system.

Delete User

Removes users from the Sofia system, highlighting ID requirements.

Review Data

Review Patient Results

Accesses and filters records of previously run patient tests.

Review QC Results

Accesses and reviews records of previously run Quality Control tests.

Review Calibration Results

Accesses and reviews records of previously performed Calibration Checks.

View Lot Status

Displays QC Kit/Lot status and expiration dates for assays.

View Test Types

Lists installed Test Types and their corresponding version numbers.

Sofia Statistics

View Analyzer Info

Displays firmware, bootware, hardware versions, scan count, and serial number.

View User History

Allows supervisors to view user details, including test types and result counts.

View Message Log

Displays system messages with corresponding codes, dates, and times.

Load/Save

Save Settings to SD Card

Clones Sofia settings to an SD Card for duplication onto other Sofia units.

Load Settings From SD Card

Loads settings from an SD Card onto another Sofia unit.

Save Test Records to SD Card

Exports test records (patient, QC, calibration) to an SD Card for backup or analysis.

Update

Load Sofia Firmware

Installs firmware updates from an SD Card or the Cloud to improve Sofia functionality.

Load Firmware from SD Card

Installs new Sofia firmware by loading it from an SD Card.

Load Firmware from Cloud

Installs new Sofia firmware by loading it from the Cloud.

Test Cloud Connection

Verifies the router connection to the Cloud for downloading firmware and other updates.

Load Language File

Installs language files from an SD Card or Cloud for display on the Sofia.

Load Language File from SD Card

Loads a new language file onto the Sofia system using an SD Card.

Load Language File from Cloud

Loads a new language file onto the Sofia system from the Cloud.

Test Cloud Connection

Verifies the router connection to the Cloud for downloading language files.

Calibration Check

Perform Sofia Calibration Check

Details the process of using the Calibration Cassette to check Sofia's optics and functions.

Calibration Results

Explains how calibration results are displayed ('Passed' or 'Failed') and stored.

Run QC

QC Results

Accesses and reviews records of Quality Control tests performed on the Sofia.

Run Patient Specimens

Select Development Mode

Choose between WALK AWAY or READ NOW modes for running patient tests.

Change Development Mode

Allows the user to select or change the development mode for running tests.

Enter the User ID

Instructions for entering or scanning the User ID for test initiation.

Enter the Patient ID

Instructions for entering or scanning the Patient ID for test initiation.

Enter the Order #, if applicable

Instructions for entering or scanning the Order Number for test initiation.

Test Procedure

Guides the user through the process of inserting the test cassette in WALK AWAY and READ NOW modes.

Press START Test

Describes the action of pressing START Test and inserting the cassette.

Patient Test Results

Explains how test results are displayed, printed, and how to handle invalid controls.

Network Configuration

Set Network Configuration

Configures IP address, network address, subnet mask, gateway, and port number.

Update Settings

Set Update Parameters

Sets IP Address and Port Number for downloading Test Type Files, Language Files, or Firmware via Cloud.

Laboratory Information System (LIS)

LIS Parameters and Settings

Configures LIS address, port number, auto send, and queue results options.

Send Results to LIS

Send Unsent Results

Sends all results that have not yet been transmitted to the LIS.

Send Last Result

Sends only the most recent result to the LIS.

Send All Results

Sends all available results to the LIS.

Send All Patient Results

Sends all patient test results to the LIS.

Send All QC Results

Sends all Quality Control results to the LIS.

Test LIS Connection

Verifies the connection to the Laboratory Information System.

Surveillance Mode

Sofia and Virena Router Connection Installation

Refer to separate instructions for setting up the Sofia with the Virena Router.

Set Network Configuration

Configures IP address and network settings for the Sofia device.

Surveillance Mode Set Up

Configures parameters for Surveillance Mode, including age, patient ID, order number, and auto send settings.

Virena Router Connection Verification

Test SURV Connection

Verifies the connection to the SURV receiver for data transmission.

Performing Tests in Surveillance Mode

Patient Demographics

Screen for entering patient demographic data like age, status, and study codes.

Send Results to SURV Receiver

Options for sending results (unsent, last, all) to the SURV receiver.

Shutdown

Maintenance and Cleaning

Maintenance

Notes that maintenance, except for basic tasks, must be performed by Quidel.

Battery Power

Details battery intended use, installation, and changing procedures.

Cleaning

Provides instructions to reduce risk of electrical shock during cleaning and cleaning solutions.

Removing the Drawer for Cleaning

Step-by-step guide on how to remove the cassette drawer for cleaning.

Appendices

Appendix A Technical Specifications

Provides detailed technical specifications for the Sofia device and barcode scanner.

Appendix B System Troubleshooting

Lists common symptoms, causes, and actions for troubleshooting Sofia device issues.

Appendix B System Troubleshooting

Error Messages

Lists potential error codes, their descriptions, actions, and codes for troubleshooting.

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