Afinion™ AS100 Analyzer System, consisting of the Afinion™ AS100 Analyzer and the Afinion™ Test
Cartridges, is for in vitro diagnostic use only.
Afinion™ AS100 is a compact multi-assay analyzer for point-of-care testing. It is designed to analyze the
Afinion™ Test Cartridges.The Afinion™ Analyzer System is easy to use, rapid and gives reliable and accurate
This User Manual will guide you through installation, operation and maintenance of your 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 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
Afinion™ AS100 Analyzer.
Some of the information in this User Manual is accompanied with a symbol that points you to the following
Warnings and precautions
References to the Package Inserts and Quick Guides for the specific Afinion™ tests and control kits
When unpacking, check the contents against the list below and examine the components for signs of
The Afinion™ AS100 package unit includes:
• Afinion™ AS100 Analyzer
• Power cable
• Power cord adapter, 24 volt power supply
• Quick Guides for the available 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.
Description of the Afinion™ AS100 Analyzer
Figure 1 shows the main exterior parts of the Afinion™ AS100 Analyzer.
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.
For connecting to power cord adapter. Options for printer,
barcode reader and/or PC connections.
Do not open the lid manually.
The 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 Afinion™ Test Cartridge with its functional parts:
1 Sampling device:
For collection of patient sample or control.
1a - closed position
1b - lifted position
Glass 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.
ANALYZER SYSTEM DESCRIPTION
The Afinion™ AS100 Analyzer has two main user interfaces, the touch screen and the cartridge chamber.
The Analyzer is easily operated using the icons that appear on the screen. Only the icons you need to use at
each operative step are displayed.When an icon is touched, it will turn grey and its function will be activated.
Text messages that appear on the screen will help guide you through the testing procedure.The functions of
the icons are explained in the “Gallery of icons”, page 10.
The other main operative part of the Afinion™ AS100 Analyzer is the cartridge chamber.The cartridge
chamber is designed to receive the Test Cartridge in one orientation only.The lid must be manually closed,
but opens automatically.When a new Test Cartridge is placed in the chamber, manually closing the lid will
initiate the analysis.When the analysis is complete the lid will open automatically.The lid protects the cartridge
chamber from dust, dirt and humidity during processing and when the Analyzer is not in use.
• The lid must be manually closed, but opens automatically. Do not open the lid manually.
• Use the fingertips only on the touch screen. Do not use pens or other sharp instruments.
The screen saver will turn on after 3 minutes, if the touch screen is not in use.To re-activate, touch the
Light signals (the red and green LEDs)
The red diode is illuminated when the Analyzer is busy. A flashing red light is seen when an information
code is displayed.The green diode is illuminated when the Analyzer is free and ready for use. A flashing
green light indicates completion of an analysis.
A short beep indicates completion of an analysis.Two beeps indicate an information or error message.
1 Text message
3 The lid in open position
with a Test Cartridge