ABL80 FLEX CO-OX - OSM version Product Overview February 2011 Duff Pickering – February 28, 2011
Dec 29, 2015
ABL80 FLEX CO-OX- OSM version
Product OverviewFebruary 2011
Duff Pickering – February 28, 2011
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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 applicationsAutomatic 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)
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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.
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System Configuration
ABL80 FLEX CO-OX analyzer Now with either OSM software or CO-OX
software Analyzer hardware is the same
ABL80 FLEX CO-OX – OSM version
ABL80 FLEX CO-OX- CO-OX version
OSM SW CO-OX SW
ABL80 FLEX CO-OX analyzer hardware
- plus -
Software version
System Configuration
393-841
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System Configuration
Two configurations of analyzer: OSM and CO-OX Two sets of consumables: OSM and CO-OX
An
alyz
erC
on
sum
able
s
?
Not possible to use
OSM consumables on CO-OX analyzer
or
CO-OX consumables on OSM analyzer
OSM CO-OX
CO-OX consumables
OSM consumables
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Field Conversions
The ABL80 FLEX CO-OX system configuration can be changed in the field CO-OX to OSM OSM to CO-OX
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
CO-OXOSM
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Main Menu: CO-OX vs OSM systems
Appearance of Main Menu
Main Menuwith CO-OX SW
Differences between the two Main Menus:1. OSM Watermark with the OSM SW2. “Enter Standby” button with the OSM SW (No Standby on CO-OX SW)3. Only CO-OX parameters in Parameter Bar
Main Menuwith OSM SW
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Identification of SW configuration
ABL80 FLEX CO-OX – OSM version
ABL80 FLEX CO-OX- CO-OX version
Sys
tem
In
form
atio
n s
cree
nP
rin
tou
t
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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 CO-OX SW
SC80 for CO-OX SW
Existing labels, for ABL80 CO-OX
SP80 for OSM SW
New Labels, for OSM80
SC80 for OSM SW
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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.
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Process to order a new ABL80 FLEX CO-OX analyzer, after OSM version is released
Item 1All 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 2All 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
1. ABL80 FLEX CO-OX analyzer with OSM SW preinstalled
2. Plastic bag, with 933-133 label, containing CD with OSM SW
1. ABL80 FLEX CO-OX analyzer with CO-OX SW preinstalled.
2. Plastic bag, with 933-132 label, containing CD with CO-OX SW
Invoiced items1. 393-841 ABL80 FLEX CO-OX analyzer2. 933-133 OSM SW preinstalled
1. 393-841 ABL80 FLEX CO-OX analyzer2. 933-132 CO-OX SW preinstalled
Shipping documents – items listed
1. 393-841 ABL80 FLEX CO-OX analyzer2. 933-133 OSM SW preinstalled
1. 393-841 ABL80 FLEX CO-OX analyzer2. 933-132 CO-OX SW preinstalled
Process to order ABL80 CO-OX analyzer after OSM is released
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The analyzer shipping box
Inside the boxOutside the box
CO
-OX
OS
M
Preinstalled CO-OX SW 933-132
Preinstalled OSM SW 933-133
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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 days150 days
(target 180 days)120 days
Sensor cassette 180 days 90 days120 days
(target 180 days)120 days
In-use life
Solution pack(maximum number of
days)
60 daysDepending on usage
Including the frequency that
Standby Mode is used
30 daysDepending on usage
60 daysDepending on usage Including the frequency
that Standby Mode is used
30 daysDepending on
usage
Sensor cassette 60 days30 days
(some versions have 15 days
60 days(some versions have 30
or 15 days)
30 days(some versions have 15 days)
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
OSM Consumables
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Solution pack construction
All solution packs for the series of ABL80 analyzers contain four pouches
1
2
3
4
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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.
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
48
0 C
yc
les
of
So
l 1
Sol 1 – 330 cycles C8701
Sol 1 – 150 cycles C8703
Sol 2 – 150 cycles C8702
Sol 3 – 150 cycles C8704
OSM80 Solution pack
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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
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 – 330 cycles C8701
Sol 1 – 150 cycles C8703
Sol 2 – 150 cycles C8702
Sol 3 – 150 cycles C8704
OSM80 Solution pack
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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
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.
Sol 1 – 330 cycles C8701
Sol 1 – 150 cycles C8703
Sol 2 – 150 cycles C8702
Sol 3 – 150 cycles C8704
OSM80 Solution pack
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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.
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Enter/Exit Standby Mode
1. 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
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Enter/Exit Standby Mode
2. 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
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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 60
2 Full Days only 7 60
2 Full Days + 5 nights 7 60
Assumption: No manual QC/dayFull Day Standby = 24 hour periodNight 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.
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In-use life of OSM solution pack
OSM version
Standby Scenario - Weekly ScheduleCO-OX version
No Standby
Standby7 nights
Standby2 Full days
(Weekend) only
Standby2 Full days (Weekend)
+ 5 nightsNo Standby
Tests per day
Days In-use
No. of packs per year
Days In-use
No. of packs
per year
Days In-use
No. of packs
per yearDays In-use
No. of packs per year
Days In-useNo. of packs
per year
0 60 6.1 60 6.1 60 6.1 60 6.1 30.0 12.2
1 60 6.1 60 6.1 60 6.1 60 6.1 30.0 12.2
2 60 6.1 60 6.1 60 6.1 60 6.1 28.2 12.9
3 60 6.1 60 6.1 60 6.1 60 6.1 25.1 14.5
4 59 6.2 60 6.1 60 6.1 60 6.1 22.6 16.2
5 52 7.0 55 6.6 60 6.1 60 6.1 20.6 17.7
6 47 7.8 49 7.4 60 6.1 60 6.1 18.9 19.3
7 43 8.5 45 8.2 60 6.1 60 6.1 17.5 20.9
8 39 9.3 41 8.9 55 6.6 57 6.4 16.2 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 47 7.7 49 7.5 14.2 25.7
11 31 11.6 33 11.2 44 8.3 45 8.0 13.4 27.2
12 30 12.4 30 12.0 41 8.8 42 8.6 12.7 28.7
13 28 13.1 29 12.8 39 9.4 40 9.1 12.0 30.4
14 26 13.9 27 13.5 37 9.9 38 9.7 11.4 32.0
15 25 14.7 26 14.3 35 10.5 36 10.2 10.9 33.5
20 20 18.5 20 18.1 28 13.2 28 13.0 8.8 41.5
Assumptions: 1. No Manual QC performed, and 2. System Cycle Frequency of 24 hours
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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.
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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:1. Manual “on-demand” steps2. Scheduled automatic steps3. Remotely enter (and exit) standby from RADIANCE
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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.
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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
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Range+ material and the OSM version
Range+ QUALICHECK
Control Ranges
Lots
Level 1 S7930 0007-0009
Level 2 S7940 0009-0011
Level 3 S7950 0006-0008
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:
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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.