New User Software version V5.2.

3 for
BA200/BA400

Dear Partner,

With this launch,, we want to inform you of the availability of a new user software version for our systems
BA200 and BA400: V5.2.3, which incorporates new and important developments among which we
highlight the incorporation of a session time counter.

The update of the software versions to the new version V5.2.3 is mandatory and it also requires the
firmware update of the analyzer to version v3.80.5 (included in the same setup). This update forces to a
new temperature adjustment of the reactions rotor, which has been considered necessary to apply a
correction for the lack of commutability between the human serum matrix and certain reference materials
for HDL Cholesterol.

With this decision, after updating the software, we avoid the need to apply the correction factor 0.7 in the
values for CHOLESTEROL HDL/LDL CALIBRATOR code 11693 and in the LIPID CONTROL SERUM
codes 18040/18041, in combination with the reagent HDL CHOLESTEROL (DIRECT) codes
21557/23557 for use in BA200. This correction was informed by its corresponding communication of July
2018: "HDL CHOL in BA200 - HDL CHOL in BA200".

The warning note that has recently been included inside the reagent kit codes 21557 and 23557 has no
effect after the update of this new software version and once the new setting has been made.

The temperature adjustment must be carried out by duly trained technical people and following the
instructions described in the video "BAX00 Software upgrade guide 5.2" that you will find together with
the setup of the version. This adjustment is mandatory and could force to a new calibration of all tests that
are executed in the analyzer, depending on the degree of the adjustment.

BIOSYSTEMS, S.A. Customer support

Costa Brava, 30, customersupport@biosystems.es
08030 BARCELONA 25/07/19
Tel. +34 933 11 08 11 Pag 1/9
 Upon opening the application after the firmware update (v3.80.5), the corresponding reminder message
about the mandatory new adjustment will appear:

What's new in the User Software Version V5.2.3:

1. The incorporation of the session time counter.

2. The samples that finished the sampling are highlighted in pink.
3. Software adjustement according to the resolution size of the computer screen.
4. New automated cleaning procedure for stirrers.
5. The possibility of editing and adding new names for the different sample types.
6. The possibility of entering a default value in External Tests.
7. The improvement in sample identification during the manual creation of the work session.
8. The possibility of sorting the list of results according to different criteria.
9. The improvement of the management of expired Baseline.
10. LIS is only consulted for work orders for new samples positioned and read after a paused
work session.

You can find detailed information about each new functionality in this document, in the section Details
about the new functionalities (page. 4).

Together with the new setup version 5.2.3, we offer new auxiliary files for tests and contaminations
(now in .tst version) to update parameterizations in some tests. Please remember that from V5.1.1.1, the
modifications in parameterizations and contaminations are not executed by updating the user software
versions.

These modifications must be done through the functionality of the user software: "Programming import"
or be done manually.

BIOSYSTEMS, S.A. Customer support

Costa Brava, 30, customersupport@biosystems.es
08030 BARCELONA 25/07/19
Tel. +34 933 11 08 11 Pag 2/9
 New auxiliary files for tests and contaminations independent of the user software version (.tst):

1. BAx00_New_Kappa_Lambda_v52.tst incorporates the new Kappa and Lambda tests to the

programming of parameters for BA200 and BA400

System Application Change description

BA200/BA400 KAPPA New application
BA200/BA400 LAMBDA New application
The contaminations caused by these reagents are included in the same file: HBA1C-DIR, PROTEIN
URINE and UIBC, as well as the Calculated Test KAPPA/LAMBDA for both SER and PLM.

2. BA400_Update_Tests_Param_V52.tst incorporates modifications in CRP-hs and HbA1C-DIR

Application Change description from to

C-REACTIVE PROTEIN-hs (CRP-hs) Reading 1 (cycle) 40 38
HEMOGLOBIN A1C-DIRECT (HbA1C-DIR) Blank Absorbance Limit 0.500 0.700

3. BA200_Update_Tests_Param_v52.tst incorporates modifications in CRP-hs and HbA1C-DIR

Application Change description from to

C-REACTIVE PROTEIN-hs (CRP-hs) Reading 1 (cycle) 20 19
HEMOGLOBIN A1C-DIRECT (HbA1C-DIR) Blank Absorbance Limit 0.500 0.700

4. BA400_Contaminations_v523.tst incorporates the following contamination. Additionally, all

parameterization of the test is updated to the official default configuration.

System Contaminant Contaminated Wash

BA400 BILIRUBIN (DIRECT) [DPD] PHOSPHORUS

5. BA200_Contaminations_v523.tst incorporates the following contaminations. In addition, the

parameterizations of the tests are updated to the official default configuration.

System Contaminant Contaminated Wash

BA200 UNSATURATED IRON BINDING CAPACITY (UIBC) TRIGLYCERIDES
BA200 UNSATURATED IRON BINDING CAPACITY (UIBC) URIC ACID
BA200 IRON FERROZINE URIC ACID
BA200 IRON FERROZINE TRIGLYCERIDES
BA200 BILIRUBIN DIRECT [DPD] PHOSPHORUS Washing solution 2
BA200 BILIRUBIN DIRECT [DPD] UIBC
BA200 BILIRUBIN TOTAL [DPD] ALBUMIN-MAU Washing solution 2
BA200 BILIRUBIN TOTAL [DPD] PROTEIN URINE Washing solution 2
BA200 BILIRUBIN TOTAL [DPD] ALT-GPT
BA200 BILIRUBIN TOTAL [DPD] AST-GOT
BA200 BILIRUBIN TOTAL [DPD] HBA1C-DIRECT
BA200 BILIRUBIN TOTAL [DPD] UREA-BUN-UV

These modifications appear already incorporated when a new installation of the user software is
performed (without previous version updates).

BIOSYSTEMS, S.A. Customer support

Costa Brava, 30, customersupport@biosystems.es
08030 BARCELONA 25/07/19
Tel. +34 933 11 08 11 Pag 3/9
 These files only incorporate the latest modifications made from software version V5.1.4. For the rest of
parameterizations updates, when the system is updated from versions prior to V5.1.4, the auxiliary files of
tests and contaminations already reported in previous communications must be used: V5.1.1.1 and
V5.1.4 . For this purpose, there are now new files with the extension ".tst". Files with a ".test" extension
were only applicable for updates to software versions prior to V5.2.3.

You must consult the content for each auxiliary files of tests and contaminations in the specific Excel file
named: "Auxiliary files for Tests and Contaminants v5.2.3". You can find the new auxiliary files of tests
and contaminations (with extension tst) and the Excel file in:

https://cloudmkt.biosystems.es/index.php/s/gGanDZmPQXSrp4H

A new user software V5.2.3 for each BA analyzer and the training video to carry out the temperature
adjustment can be found in the following link.

https://cloudmkt.biosystems.es/index.php/s/jqwmBsGnXDYT3S8

In the user software update and tests configuration import through the auxiliary files of tests and
contaminations, a Restorepoint document is automatically created and saved just prior to the moment of
the update. In the event of an error, you can return to the previous situation by reloading this document.

The Restorepoints can be found in:

C:\Users\Public\Documents\BA400\RestorePoints\
C:\Users\Public\Documents\BA200\RestorePoints\

The serial numbers of the analyzers BA200 and BA400 with the new Firmware version v3.80.5 already
installed, and with the corresponding temperature adjustment already updated are:

BA400: 834001760
BA200: 832000549

From these serial numbers, the correction of 0.7 does not need to be applied in the values for
CHOLESTEROL HDL/LDL CALIBRATOR code 11693, nor in the LIPID CONTROL SERUM codes
18040/18041, mentioned in the first page.

Details about the new incorporated functionalities:

1. The incorporation of the session time counter

The remaining time for the end of the work session, with all its obtained results, is displayed by a time
counter located in the upper right part of the screen.

The session timer appears only and as long as a work session is entered and it marks the time until the
generation of the last result is showed. After the last result, the analyzer will take two additional minutes
to wash the last used wells.

BIOSYSTEMS, S.A. Customer support

Costa Brava, 30, customersupport@biosystems.es
08030 BARCELONA 25/07/19
Tel. +34 933 11 08 11 Pag 4/9
 2. The samples that finished the sampling are highlighted in pink

In the sample rotor, the samples that are already pipetted in all their tests and have not yet reported all
their results are highlighted in pink color. They turn to green when all the results of their tests have been
reported.

The pink coloration helps to identify the samples that can be removed from the sample rotor during a
possible “Pause”.

We can visualize the meaning of the different colorations for samples and reagents by selecting the icon
in the main menu called "Show Legend".

3. Software adjustment according to the resolution size of the computer screen

The application display is adjusted to the entire monitor according to the configured screen resolution.

BIOSYSTEMS, S.A. Customer support

Costa Brava, 30, customersupport@biosystems.es
08030 BARCELONA 25/07/19
Tel. +34 933 11 08 11 Pag 5/9
 4. New automated cleaning procedure for stirrers

There is a new warning message regarding the expiration of the cleaning procedure of the mixers: The
message appears a week after the last cleaning was performed:

In addition to the information shown in the main menu, the software notifies us, by means of a pop-up
message, on the need to execute the cleaning procedure of the stirrers automatically when the analyzer
is turned off:

The positioning of the acid (WS1) and alkaline (WS2) washing solutions in positions 86 and 87 of reagent
rotor are necessary to clean the stirrers. Unfortunately, the positions described in the user manual (87
and 88) are incorrect and will be corrected in the next software version.

The user can postpone the recommended maintenance action by deselecting the option. The reminder
will reappear on the next shutdown.

An alkaline solution is now also required for the BA400 analyzer from this automated procedure. The
increase in consumption of the two washing solutions must be considered, taking into account that 600µL
of each of them are consumed in each maintenance.

5. The possibility of editing and adding new names for the different sample types

We can customize the names of the different sample types, modifying the code of the sample type and its
description. Up to 30 sample types are available that can be configured according to your needs:

BIOSYSTEMS, S.A. Customer support

Costa Brava, 30, customersupport@biosystems.es
08030 BARCELONA 25/07/19
Tel. +34 933 11 08 11 Pag 6/9
 The implications that these configurations may condition in the "LIS Mapping" menu must be taken into
account:

6. The possibility of entering a default value in External Tests

There is now the possibility of entering a default value for each “External Test”, which will be included
along with the rest of the sample results, until it is edited and modified by the user in "Sample request” or
in "Worksession results".

If the default value is "0", the value must be manually edited by the user in each of the samples, as it was
done so far.

7. The improvement in samples identification during the manual creation of the work session

We can now enter the identifications of different samples by sequential increment from a desired
identification number: This functionality allows to enter in the work list several samples with the same
profile of tests.

BIOSYSTEMS, S.A. Customer support

Costa Brava, 30, customersupport@biosystems.es
08030 BARCELONA 25/07/19
Tel. +34 933 11 08 11 Pag 7/9
 Once the initial sample identification has been introduced, the number of samples to be generated has
been edited and the desired tests selected, the work session is automatically created with the sequential
identification of the samples from the initial sample identification. So many sample codes are generated
according to the number entered.

The previous identification of the samples can also be renamed in an increasing order by moving the
mouse with the left button selected, from a desired sample.

8. The possibility of sorting the list of results according to different criteria

The list of results can now be sorted by the following criteria:

• Alphabetical ascending order
• Alphabetical descending order
• According to the patients selected in the sample request screen

9. The improvement in the management of expired Baseline

When starting the execution of a work list, if there is an expired maintenance (replacement of the
reactions rotor or new baseline), a pop-up message will appear where the user can select what is desired
at that moment.

BIOSYSTEMS, S.A. Customer support

Costa Brava, 30, customersupport@biosystems.es
08030 BARCELONA 25/07/19
Tel. +34 933 11 08 11 Pag 8/9
 The user can postpone the recommended maintenance action to be executed manually a posteriori,
through the selection in the main menu of the application:

10. LIS is only consulted for work orders for new samples positioned and read after a paused
work session

When selecting “Continuous” after leaving "Pause" status with the activated automatic sample barcode
reading configuration, the analyzer will only ask to LIS for those samples that are new (without prior
request). The samples that were already read in the same work session are not treated again by the LIS.

We apply the continuous improvement in our own systems to adapt them better to the new and real
needs of our users. With this premise and result of the direct requests of our users, we will prioritize the
improvement in the functionality of the Continuous Sample Load in future versions of Software, by
means of a significant reduction of the waiting time to enter and exit the state of "Pause". We hope we
can offer this solution very soon.

The code of the DVD is: AC16359.

For more detailed information or if you have any questions, please feel free to contact us.

Ignasi Roig
Product Manager

BIOSYSTEMS, S.A. Customer support

Costa Brava, 30, customersupport@biosystems.es
08030 BARCELONA 25/07/19
Tel. +34 933 11 08 11 Pag 9/9