How The Alere Afinion ™ As100 Analyzer System Works; Internal Process Control; The Analyzer Self-Test; The Fail-Safe Mechanisms - Abbott ALERE AFINION AS100 Manual Del Usuario

Analyzer System Description
How the Alere Afinion AS100 Analyzer System works
™
The Alere 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 (Figure 2). When the Test Cartridge enters the Analyzer, the integrated camera reads the barcode. When the Test
Cartridge enters the Analyzer the integrated camera reads the barcode, which then initiates the processing of the Test Cartridge. The
sample and reagents are automatically transferred between the wells. An internal camera monitors the entire process. Light-emitting
diodes (LEDs) illuminate the reaction area, which can be either a coloured 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.

Internal process control

The Analyzer self-test

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 27).
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 does not interrupt any analysis of the Test Cartridge.

The fail-safe mechanisms

Fail-safe mechanisms are included to secure safe processing. The integrated camera inspects the test cartridges initially before the
process starts and during the assay. If defects are detected (e.g. broken capillary, the cartridge is used past its expiry 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.

External process control

Patient ID
The Alere Afinion patient ID functionality will, if configured, allow up to four patient ID fields to be entered.
The Patient ID will be stored with each patient test result in the result records.

Operator ID

The Alere Afinion operator functionality will, if configured, require the operators to login before testing. The functionality may also
prevent un-authorized operators to login, perform tests and configuration.
The operator ID will be stored with each test result in the result records.

Quality Control lockout

The Alere Afinion QC lockout function allows you to configure the instrument to automatically enforce your local required frequency of
control testing. If the required control test has not been performed or the control result is outside the acceptable range, the instrument will
disable patient testing for this assay.
For manufacturer recommendations (see "Frequency of control testing" page 18).
For more information regarding these functionalities (see "Configuration" page 12–17).

Calibration

The Alere 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 (Figure 2).
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 the results. Calibration by the operator is thus not required.
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