The Afinion™ AS100 Analyzer System uses different chemical and mechanical assay methods combined with
advanced, computerized processing and measuring technology.
A Test Cartridge with patient sample or control is placed in the cartridge chamber of the Analyzer. By manually
closing the lid, the Test Cartridge is transported into the analysis compartment of the Analyzer.Test and lot
specific information is obtained from the barcode label, which then initiates the processing of the Test
Cartridge.The sample and reagents are automatically transferred between the wells. A monochrome solid-state
camera monitors the entire process.When the assay is completed, light-emitting diodes (LEDs) illuminate the
final reaction area, which can be either a colored membrane or a reaction well.The camera detects the
reflected or transmitted light, which is converted to a test result and displayed on the touch screen.When
the user accepts the result, the lid covering the cartridge chamber opens automatically and the used Test
Cartridge can be removed and discarded.The Analyzer is then ready for the next run.
A self-test is performed during start-up of the Analyzer to ensure that the instrument is operating according
to established specifications.The self-test validates:
• Hardware and software integrity
• Test Cartridge transport system
• Liquid transport system
• Camera vision system
If the self-test fails at any point the red LED will start flashing and an information code will be displayed on
the touch screen (see “Information codes and troubleshooting”, page 29). If the Analyzer is unable to use the
display, only the red LED will be flashing.
When the Analyzer is switched on for a longer period, it will automatically restart once a day to ensure that
a self-test is done regularly.This procedure will not interrupt any Test Cartridge measurements.
Fail-safe mechanisms are included to secure safe processing.The integrated camera inspects the test cartridges
initially before the process starts. If defects are detected (e.g. broken capillary, the cartridge is used past its
expiration date), the Test Cartridge is rejected and an information code is displayed. During processing vital
functions and components (e.g. pumps, heater) are supervised.When problems are detected by the built-in
safety mechanism, the process will be aborted and an information code will be displayed.
The Afinion™ AS100 Analyzer has been manufactured to deliver reliable and accurate results. During
manufacturing, the Analyzers are calibrated against a reference system.This procedure has been established
to ensure that all Analyzers operate within identical tolerance limits.
Test specific calibration data are established for each lot of test cartridges and then stored in the barcode label.
When the Test Cartridge enters the Analyzer, the integrated camera reads the barcode.The calibration data
for the actual lot are transferred to the instrument and used for calculating results. Calibration by the operator
is thus not required.
Touching an icon on the screen will activate the function of this icon. All the icons that may appear during
operation of the Afinion™ AS100 Analyzer are explained below by their function.
Patient sample mode Select patient sample mode.
Select control mode.
Enter patient ID.
Enter control ID.
View patient result records.
View control result records.
Enter main menu (operator ID, patient records,
control records and configuration menu).
Enter operator ID.
date/time and screen/beeper).
Enter language selection.
Patient ID on/off
Enable/disable patient ID function.
Enter date/time settings (date and time).
Exit current menu and return to previous screen view.
Enter date setting.
Enter time setting.
Enter screen and beeper settings (screen contrast,
screen adjustment and beeper volume).
Enter screen contrast setting.
Enter screen alignment function.
Enter beeper volume setting.
Disable patient ID function (turns OFF when touched).
Enable patient ID function (turns ON when touched).
Table continued on next page.
Delete previous character.
View next result in the patient or control records.
View previous result in the patient or control records.
Other symbols and signs
Other symbols, signs and abbreviations that may appear during operation of the Afinion™ AS100 Analyzer are
explained below.These symbols or signs are only informative and cannot be activated like the icons.
Icon used along with a code number [#] that corresponds to
Icon illustrates the operator ID.
Icon illustrates the patient ID.
Icon illustrates the control ID.
mode is selected.
Abbreviation used in the patient records.
Abbreviation used in the patient and control records for the
run number of the analysis.This numbering is reset each day
lot number of the Test Cartridge.