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

2. 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: µL (ABL80 CO-OX: 105µL)
Measuring/Cycle time: 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)

3. 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.

4. 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
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

5. 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

6. 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
OSM to CO-OX Conversion CD, v1.36, P/N
Option key – serial number specific
CO-OX to OSM Option Key - P/N
OSM to CO-OX Option Key - P/N
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

7. 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

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

9. 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

10. New steps to order and ABL80 FLEX CO-OX analyzer
Part number 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
Preinstalled OSM SW
Preinstalled CO-OX SW
An order placed for 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.

11. 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
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
Released in Axapta only to countries
selling the OSM version
B. CO-OX SW – Pre-installed
P/N
Released in Axapta to all countries
Shipped items
ABL80 FLEX CO-OX analyzer with OSM SW preinstalled
Plastic bag, with label, containing CD with OSM SW
ABL80 FLEX CO-OX analyzer with CO-OX SW preinstalled.
Plastic bag, with label, containing CD with CO-OX SW
Invoiced items
ABL80 FLEX CO-OX analyzer
OSM SW preinstalled
CO-OX SW preinstalled
Shipping documents – items listed

12. The analyzer shipping box
Outside the box
Inside the box
CO-OX
Preinstalled CO-OX SW
OSM
Preinstalled OSM SW

13. Shelf life and In-use life on Consumables
OSM Consumables
Part No.
Consumables for the OSM configuration of the ABL80 FLEX CO-OX
Solution pack
Sensor cassette 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)

14. Solution pack construction1 2 3 4
All solution packs for the series of ABL80 analyzers contain four pouches

15. 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

16. 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

17. 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.

18. 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.

19. 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

20. 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

21. 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 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.

22. 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

23. 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.

24. 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

25. 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.

26. 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
Level 2
S7740
Level 3
S7750
Level 4
S7760

27. 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
Level 2
S7940
Level 3
S7950

28. 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.