Alere Afinion ™ as100 Analyzer us

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TESTING PROCEDURES

Operating precautions 

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        When operating the Analyzer

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        When handling the Test Cartridge

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Preparing for an Alere Afinion™ analysis 

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Collecting a sample 

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Analyzing a patient/control sample

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Using the operator ID function 

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        Entering operator ID

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Using the patient ID function 

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        Entering patient ID

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Using the control ID function 

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        Entering Control ID

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Using the QC lockout function

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        QC lockout status

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Running controls with enabled QC lockout function

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        Passed (Within the acceptable control range)

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        Failed (Above or below the acceptable control range)

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Patient and control results records

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        View, print and export patient and control results

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INFORMATION CODES AND  

TROUBLESHOOTING

When an information code appears 

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Information codes caused by assay specific limitations 

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Information codes caused by sample or Test Cartridge failure

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Information codes or messages caused by Analyzer failure 

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Other information codes

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Service information 

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MAINTENANCE AND WARRANTY

Cleaning and maintenance 

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        Cleaning the exterior 

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        Cleaning the cartridge chamber 

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Disposal of the Analyzer 

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Software upgrade 

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Warranty 

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TECHNICAL SPECIFICATIONS

Alere Afinion™ AS100 Analyzer 

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Additional equipment

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GALLERY OF ICONS

The touch buttons and their function

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Other symbols and signs 

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SYMBOLS AND ABBREVIATIONS

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TABLE OF CONTENTS

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  5

About this User Manual

This User Manual will guide you through installation, operation and maintenance of your Alere Afinion™ AS100 Analyzer. The User 

Manual also explains how the Analyzer works, describes the quality assurance system and assists you in troubleshooting. 

For analyzing patient samples or controls, please also read the test specific information given in the Package Inserts found in the 

Alere Afinion™ test kits. The Quick Guides highlight the main steps of the test procedures and contains information on proper 

quality control routines. 

It is recommended that you become familiar with the user instructions before you start operating the Alere Afinion™ AS100 Analyzer. 

Some of the information in this User Manual is accompanied with a symbol that points you to the following particulars: 

 

Operator’s handling 

 

Warnings and precautions 

 

References to the Package Inserts and Quick Guides for the specific Alere Afinion™ tests and control kits

Examining the package contents

When unpacking, check the contents against the list below and examine the components for signs of  

shipping damage.

The Alere Afinion™ AS100 package unit includes:

•  Alere Afinion™ AS100 Analyzer 

•  Power cable

•  Power cord adapter, 24 volt power supply

•  Quick Guides for the available Alere Afinion™ tests

•  User Manual

•  Installation video (CD-ROM)

If the package unit is found incomplete, please report missing items or shipping damage to your supplier. It is recommended to 

keep the shipping box in case of later transportation of the Analyzer.

INTRODUCTION

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ANALYZER SYSTEM DESCRIPTION

Description of the Alere Afinion™ AS100 Analyzer 

Figure 1 shows the main exterior parts of the Alere Afinion™ AS100 Analyzer.

Figure 1 

1

ON/OFF button:

Turns the power to the Analyzer on and off.

2

Red and green LEDs:

Light emitting diodes (LEDs) that indicate whether the Analyzer is busy or not.

3

Touch screen:

Allows you to communicate with the Analyzer through touch icons and messages.

4

The lid:

Covers and protects the cartridge chamber.

5

Cooling ribs:

Facilitate temperature control.

6

Connectors:

Connection to power cord adapter

USB port- Options for printer, barcode reader, export of patient and control record  

to USB flash and SW upgrade. 

RS232- Connectivity options to EMR and/or HIS/LIS systems through the Alere Afinion™  

Data Connectivity Converter (ADCC).

            Do not open the lid manually.

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2

3

4

5

6

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ANALYZER SYSTEM DESCRIPTION

Description of the Alere Afinion™ Test Cartridge

The Alere Afinion™ Test Cartridge is unique for each analyte to be measured, as the reagent composition, reagent volumes and the 

integrated devices are test specific. The Test Cartridge and the sampling device labels have a unique color for each test. The Test 

Cartridges are separately packed in foil pouches to protect the chemicals and plastic devices from light, dirt and humidity. A single 

Test Cartridge contains all necessary reagents for one test and is ready to use. An integrated sampling device is used for collection 

of the patient sample or control. The Test Cartridge cannot be re-used.

Figure 2 illustrates an Alere Afinion™ Test Cartridge with its functional parts:

                

Figure 2

1

Sampling device:

For collection of patient sample or control.

1a - closed position

1b - lifted position

2  Capillary:

Capillary to be filled with sample material.

3  Reaction wells:

Contains all necessary reagents for one test.

4  Handle:

For correct finger grip.

5  Barcode label:

Contains assay and lot specific information for the Analyzer.

6  Optical reading area:

Area for transmission measurement.

7  ID area:

Space for written or labeled sample identification.

Left side                                                                                Right side

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5

6

1b

2

7

3

1a

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