AQT90 FLEX – the product 28/11/2018

What is what?

User interface Adjustable color touch screen Clear screen layout and menu structure Same user interface as ABL analyzers Customizable user interface Traffic light and parameter bar Onboard tutorials Same user interface as ABL analyzers - same approach for all POC equipment from Radiometer Customizable user interface - Analyzer screens customized to fit user’s needs Traffic light and parameter bar - Quick overview of analyzer status and more detailed info with the push of a button Onboard tutorials - Immediate operator access to assistance when needed

Easy logistics Always ready: - no need for a new set of consumables before each test Only three types of consumables Cartridge Reagent Pack Printer paper Save hassle of constant replacement and better inventory management

15 Cartridge Customizable configuration: Each parameter-specific cartridge contains up to 16 test cups The instrument can be loaded with up to 15 cartridges according to your needs - max 240 tests Pre-barcoded cartridges for automatic loading into analyzer Ensures minimum time spent on replacements 15 Every cartridge is test-specific. It contains 16 tests of the same parameter except for CRP and D-dimer. These two tests require a dilution cup per test and therefore contain 8 tests per cartridge. The cartridge is barcode-labeled with data of test name, lot number and expiry date. The barcode is read automatically by an internal scanner. The AQT90 FLEX storage wheel accepts up to 15 cartridges; that means altogether a maximum of 240 tests are available. The combination of the different cartridges in the instrument is random and allows for complete customization according to patient population. Test Cartridges come in test-specific kits (boxes) with 10 cartridges and a CAL Cartridge.

Reagent Pack Same pack for all parameters 1 pack contains reagents and waste container for 200 tests Storage at room temp Plug-and-play Automatic registration by ID chip Discarded as biohazardous waste

Easy testing Just choose the parameters and press start 1 Place the closed tube directly into the inlet 2 Choose parameters on screen and press start Results are printed and sent to the HIS/LIS or directly to patient monitors Place the closed tube directly into the inlet No sample preparation is required Whole blood measurement Choose parameters on screen and press start The sample is automatically mixed, pipetted into the cup and measured After 30 seconds, the AQT90 FLEX is ready for the next sample The third sample can be added 2 minutes later etc. 3

Parameter flexibility Cardiac, coagulation, infection and pregnancy markers in a single instrument Random access Choose your parameters and press start Up to 5 parameters per sample

The CAL Cartridge Factory-defined calibration curve CAL adjustment of the individual instrument Every 6 month or with new lot of tests CAL adjustment starts automatically 8 background cups and 8 analyte cups 8 calibration cups with known analyte concentration The factory-defined calibration curve has to be adjusted to each individual instrument to eliminate/minimize differences in results which occur due to variations among instruments, e.g. due to small differences in optical sensitivity. Calibration adjustment is performed by the operator with each new lot of tests or every 6 months. The adjustment proceeds automatically when inserting a CAL Cartridge, and all 8 background cups and all 8 analyte cups are measured. The operator is prompted for calibration adjustment when inserting Test Cartridges of a new lot. The new lot cannot be used for patient samples before the calibration adjustment has been completed. 8 background cups

Built-in quality control The built-in quality control can be divided into five categories: Environmental check Ensures that the instrument is ready for testing and that the reagents are not expired System check Performs a high number of snapshot tests of the system components such as the flash lamp, optical unit and incubation temperature. Test results are stored and documented Process check Checks that errors have not occurred during testing process Verification check Ensures that reagents have not been damaged during storage prior to installation Pre-analytical check Ensures that only tests compatible with chosen anticoagulant can be selected

Quality control Built-in QC detects immediate errors and reduces the number of liquid QC Liquid QC Multi level liquid QC Ready to use

AQT90 FLEX - Liquid QC Multilevel QC in 3 levels (Troponin I, CKMB, Myoglobin, NT-proBNP and CRP) Separate QC for D-dimer in 2 levels Separate QC for hCG in 2 levels Ready to use after thawing Place vial in inlet Choose parameter(s) Press start

Sample material and tubes supported Sample types Whole-blood (max 3 hours at 22-25 °C) Plasma specimens (max 24 hours at 2-8 °C, or frozen) Anticoagulation EDTA or lithium heparin D-dimer assay: EDTA, lithium heparin, or citrate Sample tubes Generic evacuated blood collection receptacles 13 × 75 mm tubes from Becton, Dickinson and Company, Terumo and Greiner bio-one 13 × 65 mm tubes from Sarstedt AG & Co Sample volume 2 mL in sample tube Note: Tube cap color differ with anticoagulation substance and sometimes also from one manufacturer to another.

AQT90 FLEX – the product 28/11/2018