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bioMerieux MINI VIDAS User Manual

bioMerieux MINI VIDAS
202 pages
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bioMérieux SA
376 Chemin de l’Orme
69280 Marcy-l’Etoile - France
Tél: 33 (0)4 78 87 20 00
Fax: 33 (0)4 78 87 20 90
www.biomerieux.com
User Manual
Industry Use - US version
161150-849- A - en - 2016/10 – 161150-849

Table of Contents

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bioMerieux MINI VIDAS Specifications

General IconGeneral
TypeImmunoassay Analyzer
Sample CapacityUp to 12 samples at a time
TechnologyELFA (Enzyme-Linked Fluorescent Assay)
Reagent formatReady-to-use reagent strips
Sample typesSerum, plasma, urine
Power supply100-240 V, 50/60 Hz
Test MenuInfectious diseases
ConnectivityRS-232, USB
Operating Temperature18-30°C
Operating Humidity20-80% relative humidity, non-condensing
ThroughputUp to 36 tests per hour

Summary

Introduction to the System

Intended Use and Users

Defines the intended users and applications for the mini VIDAS Industry system.

Benefits and Limitations of Use

Highlights the analyzer's features, self-contained system, and supported immunoassay fields.

Warning and Safety Messages

Explains the different types of statements used to alert users to important information.

General Statements

Provides important statements applicable to all products regarding usage and safety.

Standard Symbols

Defines symbols that may appear on the instrument, package inserts, or packaging.

Safety Information

System Compliance

Details the instrument's compliance with emissions and immunity requirements.

Instrument Labels

Illustrates the positions and text of safety warning labels on the analyzer.

Safety Precautions

Outlines critical safety measures to prevent injury or instrument damage.

Precautions For Use Of Reagents

Provides guidelines for safe handling and usage of reagents.

Precautions for Samples

Details precautions for sample handling and potential issues with SPR® dots.

System Description and Basic Operations

mini VIDAS® analyzer Description

Provides an overview of the analyzer's components and overall design.

Screen and Keypad

Describes the liquid crystal display screen and the functions of the keypad and keys.

Internal Printer

Details the internally mounted thermal printer and its location.

Rear Panel Components

Identifies and describes the ports and modules located on the rear of the analyzer.

Bar Code Readers

Explains the types of bar code readers and their functions.

Memory Cards

Describes the function of memory cards for software updates and handling precautions.

Technical Data and Specifications

Lists dimensions, weight, and space requirements for the analyzer.

Electrical Specifications

Details voltage, consumption, power, fuse current, and heat emission.

Environmental Conditions

Specifies installation type, category, pollution degree, and safety requirements.

Temperature

Provides operating and storage temperature ranges for the analyzer.

Humidity

Specifies the relative humidity requirements for operation and storage.

Altitude

States the maximum operating altitude for the analyzer.

Sound Level

Indicates the sound level generated during analysis.

Technical features

Details capacity, motors, and pumping mechanisms.

Optional Hardware

Lists optional hardware like external printers and unidirectional interfaces.

Accessories for Industry Use

Describes accessories such as the VIDAS® Heat and Go instrument.

Assay Kit Specifications

Provides specifications for VIDAS® SPR® and Single Reagent Strips.

Reagents

Explains the components of VIDAS® Assay Kits and Single Reagent Strips.

Reagent Strip Label

Details the information found on the reagent strip label and its components.

SPR®

Describes the Solid Phase Receptacle (SPR®) and its role in the assay.

Standards / Calibrators and Controls

Explains the purpose and availability of standards, calibrators, and controls.

System Basics

Introduces the analyzer's function and basic principles.

Analysis Protocols

Defines the sequence of operations for performing an analysis.

Principle of a VIDAS® Assay

Explains the scientific principle behind a VIDAS® assay, including fluorescence measurement.

Analysis Methods

Describes the methods used by the analyzer to calculate assay results.

Qualitative Assays (Single Reagent Strips)

Details analysis methods for qualitative assays using single reagent strips.

Principles Of Calibration / Recalibration

Explains the calibration and recalibration processes for quantitative and qualitative assays.

Overview of Operation Elements

Describes the main components and sections of the analyzer's operation.

Strip and SPR® Sections

Details the analyzer's sections, their capacity, and how they operate.

Strip Preparation Tray

Explains the function and usage of the strip preparation tray.

Microprocessor

Describes the microprocessor's role in storing and operating assay protocols.

Incubator

Explains the temperature control systems for assays.

Detection System

Describes the optical fluorimetric scanner used for chemical change detection.

Central Processing Unit

Explains the CPU's control over operations, data analysis, and system verification.

Software Basics

Provides an overview of the analyzer's software and menu structure.

Menu Structure

Illustrates the main menu, submenus, and program groups within the software.

The Status Screen

Explains how to view the current status of the analyzer sections.

Online Help

Describes how to access the online help function for menus and programs.

Viewing Error Messages

Explains how to use the '?' key to display error messages.

Screen Paging

Details how to navigate long displays using the arrow keys or paging bar.

System Installation and Configuration

Unpacking

Provides instructions and cautions for unpacking the analyzer components.

Storage Conditions

Recommends keeping original packaging and storing equipment correctly.

Choosing A Location

Gives guidelines for selecting a suitable location, avoiding direct sunlight and heat.

Electrical connections

Refers to safety precautions for making electrical connections.

Checking Installation

Describes the verification test performed after installation.

Connecting an external bar code reader

Provides instructions for connecting an external bar code reader.

Starting the System

Details the procedure for turning on the analyzer and allowing it to warm up.

Shutting Down the System

Explains the procedure for safely shutting down the analyzer.

Configuring the mini VIDAS® analyzer

Guides users through setting up analyzer configuration parameters.

Selecting a Language

Describes how to select the display language for the analyzer.

Setting Dose Units

Explains how to set standard units for quantitative assay results.

Setting User IDs

Details how to enter and manage user IDs for reports.

Setting the Report Header

Guides on defining a custom header line for assay reports.

Setting the Date and Time

Explains how to set the analyzer's date and time for reports.

Setting Display Contrast

Describes how to adjust the display contrast for better viewing.

Selecting the Printer

Allows selection between the internal thermal printer and an external printer.

Setting the Date/time Format

Guides on setting the format for dates and times displayed on reports.

Defining the Sample ID Character Sets

Enables definition of character sets for inputting sample IDs.

Changing the Keyclick Volume

Allows adjustment of the audible tone confirming keystrokes.

Changing the Beep Volume

Allows adjustment of the volume for inactive key beeps.

Error Beeps

Explains how to set initial and final volumes for error beeps.

Setting the Final Error Volume

Allows adjustment of the final volume for error beeps.

Enabling Display Blinking

Describes how to enable display blinking for error alerts.

Miscellaneous Items

Configures various warnings concerning Master Lot data and standards.

LIS User Options

Used when the analyzer is connected to a Laboratory Information System (LIS).

Creating Normal Ranges for Assays

Allows creation of free text lines for normal ranges printed on reports.

Installing Paper in the Internal Printer

Provides step-by-step instructions for loading paper into the internal printer.

Print Screen

Guides on how to print the current screen display.

Workflow and Instructional Procedures

Routine Workflow

Presents a visual overview of the standard workflow for running assays.

Planning a Run

Covers managing job lists, defining run types, and checking assay compatibility.

Running Assays

Details the process of running assays, including master lot data entry.

Running Assays in «Load and Go» Mode

Explains the simplified 'Load and Go' mode for running assays.

Running Assays in «Defined» mode

Describes the 'Defined' mode for setting up assays with specific parameters.

Assigning a Dilution Factor

Guides on assigning a dilution factor to individual tests.

Running Internal Quality Controls (for Clinic Use Only)

Details how to run and send internal quality controls for statistical processing.

Stopping a Section

Provides instructions on how to stop processing one or more sections.

Results and Reports

The Assay Reports

Explains the automatic printing of assay reports upon run completion.

Qualitative Assays Results

Describes how qualitative assay results are interpreted against thresholds.

Quantitative Assays Results

Explains how quantitative results are determined using master curves.

Assay Report Errors

Details how error messages are displayed on assay reports.

Reprinting an Assay Report

Guides on how to reprint stored assay reports.

Validating LIS Results

Describes the process of validating results for upload to a Laboratory Information System.

Printing the mini VIDAS® Assay List

Explains how to print a list of assays with loaded Master Lot Data.

Miscellaneous Operations

Taking a Section Off line

Details how to place a section off-line or on-line.

Changing Factory Settings

Guides on modifying factory settings for keypad and display.

Testing the mini VIDAS® analyzer

Describes simple tests to verify hardware components like display and keypad.

Updating an Assay

Explains how to update assay protocols using the complete range of VIDAS® reagents.

Displaying the mini VIDAS® Software Version

Guides on how to display the current software version of the analyzer.

Updating the mini VIDAS® Software

Details the procedure for updating the analyzer's software using memory cards.

Parking themini VIDAS® analyzer

Provides instructions for carefully parking the analyzer's components.

Maintenance

Preventive Maintenance

Highlights the importance of preventive maintenance performed by bioMérieux technicians.

User Maintenance

Covers routine maintenance operations to be performed by the user.

Cleaning and Disinfection Procedures

Outlines procedures for routine cleaning and disinfection of the analyzer.

Cleaning the SPR® block (Monthly)

Provides monthly cleaning instructions for the SPR® block.

Cleaning the Reagent Strip Trays (Every 6 Months or if Needed)

Details cleaning instructions for reagent strip trays.

Cleaning the Plastic Trays (Every 6 Months or if Needed)

Provides instructions for cleaning the plastic trays.

Cleaning the Strip Preparation Trays (Every 6 Months or if Needed)

Details cleaning instructions for the strip preparation trays.

Cleaning the Outer Covers of the Instrument (Every 6 Months or if Needed)

Instructions for cleaning the instrument's outer covers.

Cleaning the Screen and Keypad (Every 6 Months or if Needed)

Instructions for cleaning the analyzer's screen and keypad.

Cleaning the Bar Code Reader (Every 6 Months or if Needed)

Instructions for cleaning the bar code reader.

Cleaning Optical Lenses (Monthly)

Provides monthly instructions for cleaning the optical lenses.

Checking the Pipetting System (Monthly)

Details monthly checks for the pipetting system's mechanisms.

Calibration and Adjustments

Covers calibration and adjustments for the optical system.

Master Curve Establishment and Calibration

Explains master curve creation and customer-performed calibration.

Appendix - Troubleshooting

Indication Of Errors

Describes how the analyzer indicates errors via beeps and blinking display.

Displaying Errors

Explains how to respond to and view error messages on the screen.

Error Messages and Recovery Procedures

Lists possible error messages and procedures for recovery.

Manually Entering Bar codes

Provides instructions for manually entering bar codes when errors occur.

Other Error Messages

Lists and explains various other error messages and their causes.

Problems that May Occur with the Bar code Reader

Troubleshoots common issues with the bar code reader.

Assay Report Errors

Explains errors that appear directly on assay reports and how to correct them.

Printer Errors

Guides on troubleshooting issues with the internal printer.

Viewing Saved Errors

Explains how to access the last ten stored error messages.

Appendix - Installing external hardware

External printer

Provides equipment requirements and installation steps for an external printer.

Installing the Bar code Reader

Details the equipment required and installation steps for the bar code reader.

Appendix - Computer interface information

Introduction

Overview of the analyzer's unidirectional interface for transmitting results.

Configuration Information

Details LIS interface options, communication settings, and data formats.

Example of a mini VIDAS® Upload

Shows an example format of data uploaded from the analyzer.

Appendix - Technical Data and Specifications (previous versions of mini VIDAS® analyzers)

Dimensions

Lists the packed and unpacked dimensions of older analyzer versions.

Weight

Specifies the packed and unpacked weight of older analyzer versions.

Physical Space Requirements

Details the required height, width, and depth for analyzer placement.

Electrical Specifications

Lists electrical specifications like voltage, consumption, and power.

Environmental Conditions

Specifies operating conditions including temperature, humidity, and altitude.

Technical features

Details capacity, motors, pumping, temperature control, and accuracy.

Optics

Describes the detector, detection range, and automatic checking of the optics.

Assay Kit Specifications

Provides specifications for VIDAS® SPR® and Single Reagent Strips.

Appendix - Glossary

Assay

Definition of a complete test procedure using immunological and fluorescent methods.

Assay code

Definition of the designation for an assay used in the analyzer.

Assay Compatibility

Property allowing assay types to utilize the same protocol.

Assay kit

Package containing reagents, SPRs, and inserts for an assay.

Calibration

Process of adjusting a quantitative assay lot's standard curve.

Defined run

An assay run where types, IDs, standards, and controls are defined prior to start.

Fluorescence

Physical process where a substance emits light after exposure to specific wavelengths.

Load and Go run

An assay run where strips are placed and run without prior definition.

Master Lot Data

Data supplied with assay lots for quality control and standard curves.

Position

Slots in the analyzer for placing reagent strips and SPR® pairs.

Protocol

Sequence of computer-controlled activities needed to perform an assay.

VIDAS® Lens Cleaner

A tool for cleaning optical lenses to avoid optical drift.

Revision History

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