ABL80 FLEX CO-OX - OSM version Product Overview February 2011 Duff Pickering – February 28, 2011

OSM version of ABL80 FLEX CO-OX – Key Features CO-OX parameters only Measured parameters: ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHHb Derived parameters: ctO2, Hct, BO2, V(B) Sample volume: 65µL (ABL80 CO-OX: 105µL) Measuring/Cycle time: 60 secs. (ABL80 CO-OX: 140 secs.) New set of Sample Site options for Cardiac Cath Lab applications Automatic QC 2 levels in one QC event (System Cycle) performed once every 24 hrs. Available System Cycle frequencies are 24, 12, 8, 4, and 2 hours Extended In-use life of consumables Solution pack: 60 day in-use life (60 days is maximum in-use life; realized in-use life depends on usage, including number of patient tests and use of Standby Mode) New Standby mode to maximize in-use life of solution pack 60 days of in-use life can be achieved without Standby, up to 3 patient tests per day assumes 24 hour system cycle frequency and no manual QC Sensor cassette: 60 day in-use life 600 patient tests Extended Shelf life of consumables Solution pack: 180 days Sensor cassette: 180 days Fast Start-up time of new consumables (approx. 4 minutes for SP and 30 seconds for SC)

Sample Site options – Specific for Cardiac Cath Lab The OSM version of the ABL80 FLEX CO-OX can be configured with a set of Sample Site options that are specific for clinical applications in the Cardiac Cath Lab This new set of Sample Sites for the Cardiac Cath Lab include: Arterial line Mean PA SVC R. atrium RPA IVC L. Atrium LPA RINN R. ventricle PA wedge LINN L. ventricle Ascending Ao Femoral artery The use of this new set of sample site options must be set up by a service technician. The procedures for the service technician to follow are described in the ABL80 Service Manual (revision F), Chapter 8 – Service Procedures, in the “Sample site options” section. It is also possible to customize the sample site options. This customization can be done only by a service technician and is also described in the Service Manual (revision F), Chapter 8 – Service Procedures, in the “Sample site options” section.

CO-OX SW OSM SW System Configuration ABL80 FLEX CO-OX – OSM version ABL80 FLEX CO-OX analyzer Now with either OSM software or CO-OX software Analyzer hardware is the same 393-841 CO-OX SW OSM SW ABL80 FLEX CO-OX analyzer hardware - plus - Software version System Configuration ABL80 FLEX CO-OX – OSM version ABL80 FLEX CO-OX- CO-OX version

OSM consumables on CO-OX analyzer CO-OX consumables on OSM analyzer System Configuration Two configurations of analyzer: OSM and CO-OX Two sets of consumables: OSM and CO-OX Analyzer ? OSM CO-OX Consumables OSM consumables CO-OX consumables Not possible to use OSM consumables on CO-OX analyzer or CO-OX consumables on OSM analyzer

Field Conversions The ABL80 FLEX CO-OX system configuration can be changed in the field CO-OX to OSM OSM to CO-OX CO-OX OSM Items needed for Field Conversion: SW Conversion CD CO-OX to OSM Conversion CD, v1.50, P/N 933-134 OSM to CO-OX Conversion CD, v1.36, P/N 933-136 Option key – serial number specific CO-OX to OSM Option Key - P/N 933-135 OSM to CO-OX Option Key - P/N 933-137 When a conversion occurs, the consumables on the analyzer before the conversion occurs can not be used on the newly converted analyzer. These pre-conversion consumables will not be compatible with the new, post-conversion version of the analyzer. This is an issue to anticipate and coordinate when making the conversion

Main Menu: CO-OX vs OSM systems Appearance of Main Menu Main Menu with OSM SW Main Menu with CO-OX SW Differences between the two Main Menus: OSM Watermark with the OSM SW “Enter Standby” button with the OSM SW (No Standby on CO-OX SW) Only CO-OX parameters in Parameter Bar

Identification of SW configuration ABL80 FLEX CO-OX- CO-OX version ABL80 FLEX CO-OX – OSM version System Information screen Printout

Existing labels, for ABL80 CO-OX Consumables - Labels The name “OSM” does not appear on the labels. The differentiation of consumables is achieved by Color on labels Part numbers SP80 for OSM SW New Labels, for OSM80 SC80 for OSM SW SP80 for CO-OX SW SC80 for CO-OX SW Existing labels, for ABL80 CO-OX

New steps to order and ABL80 FLEX CO-OX analyzer Part number 393-841 is still used to order an ABL80 FLEX CO-OX analyzer, either for OSM or CO-OX configuration Now, a second part number must also be ordered to indicate which software version, OSM or CO-OX, should be pre-installed at SenDx 933-133 Preinstalled OSM SW 933-132 Preinstalled CO-OX SW An order placed for 393-841 without a corresponding order for the type of software is an incomplete order. An incomplete order can not be processed at SenDx It will be necessary to order the pre-installed SW version, too.

Process to order ABL80 CO-OX analyzer after OSM is released Process to order a new ABL80 FLEX CO-OX analyzer, after OSM version is released Item 1 All orders for new ABL80 FLEX CO-OX analyzers include Item 1 ABL80 FLEX CO-OX analyzer P/N 393-841 Currently released in Axapta to all sales companies Item 2 All orders for new ABL80 FLEX CO-OX analyzers include either A or B, as an indication of the SW version to be installed and shipped A. OSM SW – Pre-installed P/N 933-133 Released in Axapta only to countries selling the OSM version B. CO-OX SW – Pre-installed P/N 933-132 Released in Axapta to all countries Shipped items ABL80 FLEX CO-OX analyzer with OSM SW preinstalled Plastic bag, with 933-133 label, containing CD with OSM SW ABL80 FLEX CO-OX analyzer with CO-OX SW preinstalled. Plastic bag, with 933-132 label, containing CD with CO-OX SW Invoiced items 393-841 ABL80 FLEX CO-OX analyzer 933-133 OSM SW preinstalled 933-132 CO-OX SW preinstalled Shipping documents – items listed

The analyzer shipping box Outside the box Inside the box CO-OX Preinstalled CO-OX SW 933-132 OSM Preinstalled OSM SW 933-133

Shelf life and In-use life on Consumables OSM Consumables Part No. Consumables for the OSM configuration of the ABL80 FLEX CO-OX 944-341 Solution pack 945-806 Sensor cassette - 600 tests / 60 days Shelf life and In-use life on Consumables ABL80 FLEX CO-OX ABL80 FLEX OSM version CO-OX version BASIC version FLEX version Shelf life Solution pack 180 days 90 days 150 days (target 180 days) 120 days Sensor cassette In-use life (maximum number of days) 60 days Depending on usage Including the frequency that Standby Mode is used 30 days Depending on usage Including the frequency that Standby Mode is used (some versions have 15 days (some versions have 30 or 15 days) (some versions have 15 days)

Solution pack construction 1 2 3 4 All solution packs for the series of ABL80 analyzers contain four pouches

FLEX CO-OX Solution pack OSM80 Solution pack The solution pack for the OSM80 has only three solutions in the four pouches. Solution 1 is used to flush the system after every sample and to perform blank calibrations of the oximetry system. Solutions 2 and 3 contain dyes and are used to perform the automatic QC, involving two QC levels in one System Cycle. The default frequency of a System Cycle is once every 24 hours. The frequency of the System Cycle can be set to be 24, 12, 8, 4, or 2 hours. 480 cycles of Solution 1 are distributed across two solution pouches. There are 150 cycles each of Sol2 and Sol 3. In contrast, the solution pack for the CO-OX version has four solutions to provide the multiple levels of automatic QC. 480 Cycles of Sol 1 Sol 1 – 330 cycles C8701 Sol 1 – 150 cycles C8703 Sol 2 – 150 cycles C8702 Sol 3 – 150 cycles C8704 OSM80 Solution pack Sol 1 – 230 cycles C8301 Sol 3 – 110 cycles C8303 Sol 2 – 110 cycles C8302 Sol 4 – 110 cycles C8304 FLEX CO-OX Solution pack

Cycles remaining in OSM solution pack Information about the remaining cycles for each solution are found in the Solution Pack tab under System Information. The number of cycles remaining in each of the three Solution 1 pouches are shown on this screen

Standby Mode A Standby Mode feature is included with the OSM version. Standby on the OSM is similar to Standby on the ABL80 BASIC Key purpose of Standby Mode is to conserve the use of solutions to prolong the in-use life of the solution pack in order to reduce cost of operation as much as possible. Most important objective of Standby Mode is to conserve Solution 1. Saving available cycles of Solution 1 is achieved by postponing blank calibrations and System Cycles when possible Sol 1 – 330 cycles C8701 Sol 1 – 150 cycles C8703 Sol 2 – 150 cycles C8702 Sol 3 – 150 cycles C8704 OSM80 Solution pack The maximum in-use life of 60 days for the OSM solution pack can be achieved even if Standby is not used, if the number of patient tests run per day is 3 or less. That is different than on the ABL80 BASIC, where the maximum in-use life of 60 days can only be achieved if standby mode is used on the weekend and every night.

How Standby Mode Works During the Entry to Standby Mode When entering Standby, air is aspirated through the sensor cassette, but not into the hemolyzer cuvette. This means that solution remains in the hemolyzer’s cuvette during the Standby period, but not in the sensor cassette segment of the fluidic path. This is different from the ABL80 BASIC where solution remains in the sensor cassette during Standby. While In Standby Mode No fluidic activity occurs while the system remains in Standby Mode Specifically, no System Cycles or blank calibrations occur as long as the system remains in Standby Mode. No cycles of Solutions 1, 2, or 3 are used during the standby period. This is different from the ABL80 BASIC where one-half flush cycle of Solution 1 occurs every 4 hours when that system is in Standby. During the Exit from Standby Mode An aspiration / flush routine is run that consumes one half cycle of Solution 1. After Exiting Standby Mode If the standby period was longer than 48 hours, an extra flush routine is used which consumes a half cycle of Solution 1. In addition, the hemolyzer is activated for four seconds during the flush sequence. A Blank Calibration is automatically performed if it has not been performed within the previous 12 hours A System Cycle is automatically performed if it has not been performed within the previous 24 hours A valid, non-expired sensor cassette and solution pack must be installed on the analyzer for either the automatic Blank Calibration or System Cycle mentioned above to occur when exiting Standby The number of tests remaining on the sensor cassette does not affect the standby status.

Enter/Exit Standby Mode Manual “on-demand” entry and exit of Standby To enter, press the “Enter Standby” button. Upon entering Standby Mode, the traffic light will turn to yellow the system will continue to display “Ready” as an indication that the patient measurements are possible if Standby Mode is exited. “Standby” will appear directly under “Ready”. The system will stay in Standby until the user manually exits Standby Unless a schedule to exit Standby has been previously set up 30 days is the maximum Standby period To exit Standby, press the “Exit Standby” button. Enter Standby, Manually Exit Standby, Manually

Enter/Exit Standby Mode Scheduled automatic entry to and exit from Standby It is possible to set up the automatic entry to and exit from Standby as: 1. Recurring Weekly schedule (up to 7 different schedules) 2. One Time event – 30 days is the maximum length of a scheduled Standby period To access the schedule option, from the Main Menu, Select Menu  Settings  Standby To establish a recurring weekly schedule To schedule a One Time event

Use of Standby Mode – Impact on In-use life Examples of usage scenarios to reach the maximum of 60 days in-use life for the solution pack are: Estimates of In-use life for BASIC solution pack under different usage scenarios Use of Standby (Weekly basis) Patient Tests/day In-use days achieved for Solution Pack None 3 60 7 Nights only 4 2 Full Days only 7 2 Full Days + 5 nights Assumption: No manual QC/day Full Day Standby = 24 hour period Night Standby = 12 hour periods The Financial Workbook (FWB) version 8.00 includes a calculator feature to determine the in-use life of an OSM solution pack that would be realized under different usage scenarios. The calculator in the FWB ver. 8.00 can also be used to estimate the in-use life of the solution pack for the ABL80 BASIC, ABL80 FLEX, and ABL80 FLEX CO-OX (CO-OX version) under different usage scenarios.

In-use life of OSM solution pack   OSM version Standby Scenario - Weekly Schedule CO-OX version No Standby Standby 7 nights Standby 2 Full days (Weekend) only Standby 2 Full days (Weekend) + 5 nights Tests per day Days In-use No. of packs per year 60 6.1 30.0 12.2 1 2 28.2 12.9 3 25.1 14.5 4 59 6.2 22.6 16.2 5 52 7.0 55 6.6 20.6 17.7 6 47 7.8 49 7.4 18.9 19.3 7 43 8.5 45 8.2 17.5 20.9 8 39 9.3 41 8.9 57 6.4 22.5 9 36 10.1 38 9.7 51 7.2 53 6.9 15.2 24.0 10 34 10.8 35 10.5 7.7 7.5 14.2 25.7 11 31 11.6 33 11.2 44 8.3 8.0 13.4 27.2 12 30 12.4 12.0 8.8 42 8.6 12.7 28.7 13 28 13.1 29 12.8 9.4 40 9.1 30.4 14 26 13.9 27 13.5 37 9.9 11.4 32.0 15 25 14.7 14.3 10.2 10.9 33.5 20 18.5 18.1 13.2 13.0 41.5 Assumptions: 1. No Manual QC performed, and 2. System Cycle Frequency of 24 hours

Cautions about using Standby Frequent entry and exit of Standby, more than once every 12 hours, can consume more Solution 1 cycles than are saved. Because one cycle of Solution 1 is used for every exit from Standby. To save solutions, the Standby period should be at least 12 hours in order to postpone at least one Blank Calibration This extends the availability of Solution 1. The conservation of Solutions 2 and 3 is the important benefit of the Standby Mode, especially for low volume users. Optimal benefit from Standby Mode is achieved by extended standby periods, such as a weekend or longer. Information about Standby to End-users It may be necessary to actively remind and inform end-users about the need to use Standby to maximize the in-use life of the solution pack Active use of the Scheduling options to setup automatic entry to and exit from Standby may be the best approach to ensure regular use of the Standby feature.

How to Enter/Exit Standby Mode To enter Standby, the system requires that a sensor cassette be connected (though not necessarily installed) a solution pack be installed on the analyzer A minimum of 2 cycles of Solution 1 must be available for the system to enter Standby The entry to and exit from Standby Mode can be achieved in three ways: Manual “on-demand” steps Scheduled automatic steps Remotely enter (and exit) standby from RADIANCE

While in Standby The user can access all areas of the software including logs and settings. The system will display information on the Main Menu about the status of the consumables and the length of time that the system will support Standby. The system can remain in Standby for a period up to 30 days. For periods less than 30 days, the system can remain in standby as long as cycles remain in the solution pack, even if the solution pack is past its expiration date. When in a “one-time” scheduled standby event, the main menu will display the date and time the analyzer is scheduled to exit standby. The system will not allow 1. patient analysis 2. manual QC, 3. manual System Cycle 4. sensor cassette installation. Entering and exiting standby is recorded in the Event log.

QUALICHECK 5+ is used with the OSM version There are unique insert ranges for QUALICHECK 5+ for use with the OSM. Due to unique usage conditions of the consumables on the OSM, in particular the extended in-use life and smaller sample volume. QC5+ insert ranges for the CO-OX version should not be used with the OSM version, or vice versa. The use of CO-OX ranges on a OSM system, and OSM ranges on a CO-OX system, will likely result in out-of-range results. These incorrect out-of-range results would falsely indicate that there were problems with the OSM system. Supplementary inserts for QC5+ with OSM ranges are available on the RMED extranet for the following lots: QUALICHECK 5+ Control Ranges Lots Level 1 S7730 0083-0099 Level 2 S7740 0088-0104 Level 3 S7750 0085-0101 Level 4 S7760 0082-0097

Range+ material and the OSM version There are unique insert ranges for Range+ for use with the OSM. Due to unique usage conditions of the consumables on the OSM, in particular the extended in-use life and smaller sample volume. Range+ insert ranges for the CO-OX version should not be used with the OSM version, or vice versa. The use of CO-OX ranges on a OSM system, and OSM ranges on a CO-OX system, will likely result in out-of-range results. These incorrect out-of-range results would falsely indicate that there were problems with the OSM system. Supplementary inserts for Range+ with OSM ranges are available on the RMED extranet for the following lots: Range+ QUALICHECK Control Ranges Lots Level 1 S7930 0007-0009 Level 2 S7940 0009-0011 Level 3 S7950 0006-0008

tHb calibration solution (S7770) and the OSM version The use of the tHb calibration solution (S7770) is the same on all ABL80 FLEX CO-OX analyzers, with either current CO-OX software or the new OSM software. The barcode on the tHb calibration solution insert identified for the ABL80 FLEX CO-OX is used on analyzers with either software version, CO-OX and OSM. There isn't a new or unique barcode for an ABL80 FLEX CO-OX analyzer with OSM software. The recommended frequency of tHb calibration frequency is once every three months for a system with OSM software, as it is for a system with CO-OX software.