Alegria Analyser

Service Software Manual

version 5, issued in September 2012

Legal & warranty .............................................................. 3
References to other documentation.....................................................................................................4
Intended Use ......................................................................................................................................4

Overview Service Software ............................................... 5

Action Buttons .................................................................. 7
Run Field .......................................................................... 8
OD Calibration Field ........................................................ 11
Home Field ..................................................................... 12
Level Field ...................................................................... 13
Temperature Calibration Field ........................................ 14
Quality Control Field ....................................................... 14
Temperature Field .......................................................... 15
Numbers of Runs Field.................................................... 15
Menu Drop down list ....................................................... 16
Service centres ............................................................... 17

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Legal & warranty
The content of this manual are the property of ORGENTEC Diagnostika GmbH. Any re-
production in whole or in part is strictly prohibited.

At the time of printing, this manual correctly described the device and its functions.
However, as modifications may have been carried out since the production of this man-
ual, the system package contains this manual and a service manual and may contain
one or more amendments to the manuals. This manual including the service manual
and any amendments must be thoroughly read, before using the device.

ORGENTEC Diagnostika GmbH is only responsible for the reliability and performance of
the device if the following are strictly observed:

Authorized personnel (see back of manual for authorized service centres) carry out all service,
repairs and modifications.
The device must be used in accordance with the intended use and the instructions put forth in
the Safety Information section (instruction for use and this manual).
ORGENTEC Diagnostika GmbH offers one-year warranty, from the day of purchase, on defec-
tive material and assembly.
The warranty does not cover damage resulting from incorrect use or user maintenance or from
authorized software modification.
ORGENTEC Diagnostika GmbH is only responsible for replacement of defective parts, not wear
of parts.
ORGENTEC Diagnostika GmbH is not responsible for any personal injury or any damage result-
ing from incorrect use or incorrect performed service of the analyser.

If the above points are not strictly observed, the warranty will be considered invalid.

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References to other documentation
The below topics are described in Instructions for use (Use the Instructions for use together
with this service manual).

General Safety Information Calibration

Basic Information Software upgrade
Installation Maintenance
General Operation Technical specifications
Tools required

Intended Use
The Alegria analyser is intended for use by trained personnel to process and read IVD
test strips supplied by the ORGENTEC. The results obtained shall be used only in con-
junction with other medical evidence to diagnose conditions of the human body. The
Alegria analyser by it-self is not diagnostic. The instrument is to be used in medical labo-
ratories.

All service of the Alegria analyser is to be carried out by authorized service personnel.
This manual and the other manuals such as Intended Use shall be consulted for an over-
view.

The intention of this service manual is to give an overview of the main parts and sys-
tems in the instrument. References to other locations, such as manuals drawings or part
lists are to follow, if the referred document is not amended to the manual you may need
to contact you representative.

The manual will describe the Service Software and parts or procedures of interest and
not all details, i.e. the most common foreseeable issues that can be of interest to the
service personnel.

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Overview Service Software
The Service software mainly contains one Main screen with:

Menus
Action buttons
Fields with settable parameter
Status indicator

Initially starting up the service software, you will be requested to enter the communication port
you will be using to connect to the Alegria instrument this will be indicated at the bottom, left
corner with the status indicator (disconnected or connected).

Displayed message (popup box)

Select the Communication port to be used and click the Connect serial or Connect modem if a
modem is to be used.
If modem is selected a dial connection dialog will appear:

Select the number to be dialled to the Alegria analyser, and if an outside line ton number is re-
quired enter so in the outside line field.

When the connection is established the Status indicator will change to connected:

Lower left corner indication field

Note: You can change these setting from the “Connection” menu if desired

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Service Software Main Screen

The main window and its different areas

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Action Buttons

The action buttons performs a specific action when pressed, such as:

Carousel home
Carousel rotates to home position.

Rotate Carousel
Carousel rotates one “sample frame”.

Open Lid / Close Lid

Opens or closes the lid for loading sample frames.
If the Lid is open the text reads “Close lid”
If the Lid is closed the text reads “Open lid”

Load Error Log

Loads a copy off the error log from the instrument.
User can choose where to save the file and with what name.

Load Patient Archive

Loads a copy off the patient archive from the instrument.
User can choose where to save the file and with what name.

Load Self test Log

Loads a copy off the Selftest log from the instrument.
User can choose where to save the file and with what name.

Test Printer
Prints out a dummy patient on the internal printer. If a external USB printer is connected the
dummy patient will be printed on the external printer.

Change to WB # 1 (Change to WB # 2)
Changes to the other wash buffer bottle and flushes the “wash and soak” stations with this new
wash buffer.
If wash buffer # 1 is active the button reads “Change to WB # 2”
If wash buffer # 2 is active the button reads “Change to WB # 1”

Wash needles
All needles are washed with the active wash buffer.
The dispense needles are then flushed with distilled water to be ready for use.

Shake
A shake sequence is performed with the correct speed and duration.

Calibrate Carousel
A calibration of the rotating plate towards the analyse module is performed.
NOTE: There must be NO sample frames in the carousel when this is performed. After successful
calibration the instrument must be restarted for calibration to take effect.

View Logs
View encrypted error log files that have been downloaded from instrument using Export Logs
function in Settings menu. This opens an Open file dialog, select the LogData.org file. The file will
be decrypted and displayed.

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Run Field

In the Run box all stations can be tested to evaluate its functionality. Several stations can be run
simultaneously.

Strip position
This is the strip position that the stations will perform its actions in (1-30).

Check box options:

Mark the stations in the checkboxes for the ones to be tested, and then push the Run button.

Dispense
From well:
Choose from drop down list which well the dispense needle shall pipette from. If “Wash needle” is
chosen the “To Well” will be disabled. When “Wash Needle” is chosen the needle will be washed
with distilled water as it is done during an analyse run.
To Well:
Choose from drop down list which well the dispense needle shall pipette to.
Amount [µl]:
This is the amount in µl that will be pipetted. Range 10-200µl.
Standard needle / Conjugate needles:
Choose which needle that shall perform the operation.

Wash and Soak #1

The Wash and Soak station # 1 will perform a wash sequence on the chosen “Strip position”.
The strips reaction wells will first be aspirated empty and then filled up with wash buffer.
NOTE: Ensure that there is a strip in the correct “Strip position” otherwise the wash buffer will be
dispensed into the climate chamber floor.

Wash and Soak #2

The Wash and Soak station # 2 will perform a wash sequence on the chosen “Strip position”.
The strips reaction wells will first be aspirated empty and then filled up with wash buffer.
NOTE: Ensure that there is a strip in the correct “Strip position” otherwise the wash buffer will be
dispensed into the climate chamber floor.

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Dryer
The dryer stations performs a “dry” sequence on the chosen “Strip position”.
The reactions wells in the strip are aspirated dry.

Barcode
The internal barcode reader scans the strip in entered “strip position” and displays the result in
the text field.

Run
When the “Run” button is pushed the checked stations are performed.

Run OD
When the “Run OD” button is pushed, the analyse is performed on the chosen “Strip position”.
The strip position “5” can not be chosen in this test case.

The “reference” measurement for analyse module is always performed in the strip position 5 and
the “analyse” measurement is performed on the entered “Strip position”.
This means that if there is no strip in position nr 5 the reference will be performed in air.

Run OD All
When the “Run OD All” button is pushed, the analyse is performed on all “Strip positions”.
A status bar and text is displayed in the RUN field.
When completed the results are displayed.

Add to List
Fill in strip position, amount etc. then push “Add to List” button repeat until all desired transfers
are entered.
Note: For each strip position is just one action allowed at the same time.

Clear List
Clears all actions from the worklist created.

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View and Run
Now a Transfer list is shown (with all the transfer data entered), At the list top right corner a
“Run” and a “Cancel” button is located
When the “Run” button is pushed, the transfer is performed.
If the “Cancel” button is pushed you will return to previous menu.

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OD Calibration Field
The OD Calibration Field is intended for the calibration of the OD module.

A grey filter with a defined OD value is required as additional tool for the calibration of the OD.
Fix the grey filter to the SysTray in an optional strip position. Exception: Strip position “5” can
not be chosen in this test case. Assure that the grey filter completely covers the part of the strip
position through that the light will pass during OD measurement (see below picture).

Grey filter has to cover this part of an optional strip position.

Select strip position in the “RUN Field” of the software. Enter the target OD value (OD value of
the grey filter) in the “OD calibration Field” and press button “Calibrate OD”. When OD calibra-
tion is finished, measure the OD as described in chapter “Run Field” of this manual and compare
with the target OD value of the grey filter.

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Home Field

The Home field controls the different positions of: dispense needle, conjugate needle e.g.

Disp needle horizontal position

The box is checked when the carriage with the dispensing needles are in its horizontal home posi-
tion.

Disp needle vertical position

The box is checked when the standard dispensing needle is in its vertical home position.

Conj needle vertical position

The box is checked when the conjugate dispensing needle is in its vertical home position.

Wash and soak #1 vertical

The box is checked when the wash and soak station #1 needles are in its vertical home position.

Wash and soak #2 vertical

The box is checked when the wash and soak station #2 needles are in its vertical home position.

Dryer vertical
The box is checked when the dryer station needles are in its vertical home position.

Carousel
The box is checked when carousel is in its home position.

Lid closed
The box is checked when lid is in closed position.

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Level Field
The Level field indicates the actual fluid levels measured and the present temperature. The ex-
planation / criteria’s for each are explained below:

Distilled water bottle

Reads “Low” when there is less distilled water than required for running an analyse with 30
strips, otherwise it reads “OK”

Waste bottle
Reads “High” when there is less space left in bottle than required for running an analyse with 30
strips, otherwise it reads “OK”

Wash buffer bottle #1

Reads “Low” when there is less wash buffer than required for running an analyse with 30 strips,
otherwise it reads “OK”

Wash buffer bottle #2

Reads “Low” when there is less wash buffer than required for running an analyse with 30 strips,
otherwise it reads “OK”

Temperature [°C]
Reads the temperature inside the climate chamber.

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Temperature Calibration Field

The Temperature Calibration Field is intended for calibration of the temperature sensor.
An external temperature sensor is required as additional tool for the calibration of the tempera-
ture. Place the external temperature sensor in the incubation chamber of the instrument, next to
the internal temperature sensor.

Enter default value 1058 and press button “Set Constant Temporary”. Observe the actual tem-
perature shown in the “Temperature” field in the middle lower part of the main window. If the
actual temperature is the same as the temperature shown by the external temperature sensor,
press button “Set Constant Permanent” in order to permanently store the default value.

If the temperature is lower than the value indicated by the external temperature sensor, increase
the default value. If the temperature is higher than the value indicated by the external tempera-
ture sensor, decrease the default value and repeat the procedure described above to temporary
or permanently set the value.

Quality Control Field

When checking “Quality control cut-off” check box the button “Get” becomes enabled as well as
the two text fields “Min [mOD]” and “Max [mOD]”

Get
When the “Get” button is pushed the min and max values from the instrument is retrieved and
presented in the text boxes.

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Temperature Field

The Temperature field can be used to test the climate chamber. In the text field it is possible to
write in the desired target temperature for the climate chamber.

When “Climate” button is pressed down the peltier element starts to regulate to-
wards this temperature.

When pushed up it starts to regulate towards the default temperature (26°C). Note
that the temperature inside the climate chamber can be read in the “Temperature”
field in the “Level” field.

Numbers of Runs Field

The field displays the total analyses sequences the instrument has performed.

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Menu Drop down list
The drop down list has two drop down menus (Connect and Help)
The connect menu deals with the connection from the service PC to the Alegria instrument (and
the settings, how to do so).

The Connect drop down menu

To Instrument via Serial

To Instrument via Modem

Settings
The settings, pop up dialog, enables the user to select communication port and type of phone
setting (pulse or tone).

The Help drop down menu

Selecting About Alegria SSW… will display the Service Software Version.

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Service centres
Germany
ORGENTEC Diagnostika GmbH
Carl-Zeiss-Straße 49
D-55129 Mainz
Germany

Tel. +49 - (0)6131 / 92 58 - 0

Fax +49 - (0)6131 / 92 58 58

http://www.orgentec.com

Authorized Service representative:

Manufactured by:
Orgentec Diagnostika GmbH, Carl-Zeiss-Straße 49, D-55129 Mainz , Germany
Tel. +49 - (0)6131 / 92 58 - 0 Fax +49 - (0)6131 / 92 58 58
http://www.orgentec.com/

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