Built-in Hct & Software upgrade for AQT90 FLEX analyzer 09/12/2018 09-12-2018

Introduction Participants from Radiometer Medical 09/12/2018 RADIOMETER PRESENTATION Introduction Participants from Radiometer Medical Lone Christiansen, Product Manager Participants from ………………………………………. …………………………………………………………………….. 09-12-2018

Agenda Approximately a 1½ hour demonstration and training 09/12/2018 Agenda Approximately a 1½ hour demonstration and training Presentation (60 minutes) Overview – What’s included? About the new Hardware (Done during morning) About the new Software Features Cleaning procedure Supporting material Questions & Answers (15 minutes) Certificate of upgrade 09-12-2018

What’s included in the upgrade? 09/12/2018 RADIOMETER PRESENTATION What’s included in the upgrade? 1. New Hardware New Software 5. Numerous New Software features 2. Automated hematocrit determination & adjustment – “built-in Hct” 3. Automated hematocrit determination & adjustment – “short sample detection” 4. Automated cleaning system – “System Clean” 09-12-2018

About the new hardware (1/4) 09/12/2018 RADIOMETER PRESENTATION About the new hardware (1/4) 1. Hardware components Modified Inlet PCB Wash Block with integrated conductance sensor AQT90 FLEX analyzer Modified Cup-blower PCB 09-12-2018

About the new hardware (2/4) 09/12/2018 RADIOMETER PRESENTATION About the new hardware (2/4) Cut-away of Wash Block 2. How the built-in Hct module works Two Frequency Conductance Concept (400 kHz & 10 MHz) Plasma is conductive at both frequencies. Blood cells are only conductive at the higher frequency. * Conductance cell Insulators Blood flow in Blood flow out V Titanium Rings * 1 2 3 4 5 Excess Blood dispensed into module Module measures conductance at 2 frequencies Module passes values to Analyzer’s processor Processor’s algorithm determines Hct concentration Analyzer corrects measurement based on Hct concentration 09-12-2018

About the new hardware (3/4) 09/12/2018 RADIOMETER PRESENTATION About the new hardware (3/4) Cut-away of Wash Block 3. How the short-sample detection system works Sufficient Sample Volume Insufficient Sample Volume The last blood aspirated is the first dispensed. If there is blood, there is sample. 09-12-2018

About the new hardware (4/4) 09/12/2018 RADIOMETER PRESENTATION About the new hardware (4/4) Cut-away of Wash Block 4. What is “System Clean”? “System Clean” is a process for conducting a cleaning solution through the sample pathway of an AQT90 FLEX Why did we create “System Clean”? We created System Clean to prevent build-up of protein or matter on the Conductance cell in the built-in Hct module. Conductance cell In addition to the built-in Hct module, the system also conducts cleaning solution through the aspirating needle, the wash block and the wash unit. What is required to perform a “System Clean”? Software 8.3 Cleaning Tubes Blank Cartridge 09-12-2018

System Clean demo on your AQT90 FLEX 09/12/2018 RADIOMETER PRESENTATION System Clean demo on your AQT90 FLEX System Clean procedure: A routine cleaning procedure introduced on the AQT90FLEX analyser with software version 8.3. This procedure complement and enhance the internal cleaning of the analyser in order to guarantee optimal performance of the AQT90 FLEX.

Materials required Blank Cartridge: 942-962 09/12/2018 RADIOMETER PRESENTATION Materials required Blank Cartridge: 942-962 Single cartridge with sixteen test cups Shelf life: up to 12 months, stored at room temperature On board life: up to 12 months on-board the analyser Cleaning tubes: 905-843: Box of 6x cleaning tubes containing approx. 5% hypochlorite w/v Shelf life: stored refrigerated at 2˚C – 8 ˚C, up to four months On board life: single use only, should be removed and discarded immediately after use Expired cleaning tubes will not run on the AQT90FLEX

Cleaning Procedure Cleaning procedure is performed every 200 tests 09/12/2018 RADIOMETER PRESENTATION Cleaning Procedure Cleaning procedure is performed every 200 tests The cleaning cycle takes approximately 6 1/2 minutes AQT90FLEX will warn: - at 175 samples with a yellow traffic light indicating cleaning is due, - at 200 sample with a red traffic light indicating cleaning - other cleaning cycle intervals may be defined in set-up - user-defined time interval (e.g. weekly) which will re- set and override the episodic cleaning can be set up

How to perform Cleaning 09/12/2018 RADIOMETER PRESENTATION How to perform Cleaning Pre-requisites: 1. Cleaning Solution Tube 2. Blank Cartridge 3. Enough buffer in the Reagent Pack Insert the Blank Cartridge to the analyser:

How to perform Cleaning 09/12/2018 RADIOMETER PRESENTATION How to perform Cleaning 2. Place the Cleaning Solution Tube in the Inlet: System clean can also be started as follows: Menu > Analyzer status > Maintenance > Maintenance details – Press the System clean button /Cleaning Tube

09/12/2018 RADIOMETER PRESENTATION How to find system-clean record How to add notes to a system-clean record To find system-clean record if needed for documentation: Press Menu > Data logs > System-clean log To add note to a system-clean: 1. Press Menu > Data logs > System-clean log 2. Select the system-clean record of interest 3. Press note 4. Enter note and information 5. Press Back > Close

About the new software features 09/12/2018 RADIOMETER PRESENTATION About the new software features Main new features Centralized User Management “Demo” Parameter Improved Transmissions Protocols Test order retrieval Select logon method Logon 09-12-2018

Supporting material Material Available Assay Matrix Validation Sheets 09/12/2018 RADIOMETER PRESENTATION Supporting material Material Available Assay Matrix Validation Sheets AQT90 FLEX Operator’s & Reference Manuals 09-12-2018

Questions ? Thank you for your attention 09/12/2018 RADIOMETER PRESENTATION Questions ? Thank you for your attention