When operating the Analyzer
When handling the Test Cartridge
Preparing for an Alere Afinion™ analysis
Collecting a sample
Analyzing a patient/control sample
Using the operator ID function
Entering operator ID
Using the patient ID function
Entering patient ID
Using the control ID function
Entering Control ID
Using the QC lockout function
QC lockout status
Running controls with enabled QC lockout function
Passed (Within the acceptable control range)
Failed (Above or below the acceptable control range)
Patient and control results records
View, print and export patient and control results
INFORMATION CODES AND
When an information code appears
Information codes caused by assay specific limitations
Information codes caused by sample or Test Cartridge failure
Information codes or messages caused by Analyzer failure
Other information codes
MAINTENANCE AND WARRANTY
Cleaning and maintenance
Cleaning the exterior
Cleaning the cartridge chamber
Disposal of the Analyzer
Alere Afinion™ AS100 Analyzer
GALLERY OF ICONS
The touch buttons and their function
Other symbols and signs
SYMBOLS AND ABBREVIATIONS
TABLE OF CONTENTS
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:
Warnings and precautions
References to the Package Inserts and Quick Guides for the specific Alere Afinion™ tests and control kits
When unpacking, check the contents against the list below and examine the components for signs of
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.
Figure 1 shows the main exterior parts of the Alere Afinion™ AS100 Analyzer.
Red and green LEDs:
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.
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:
1a - closed position
1b - lifted position
Capillary to be filled with sample material.
3 Reaction wells:
Contains all necessary reagents for one test.
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