Service Software Manual Alegria PDF PDF

 

Alegria Analyser

Service Software Manual

version 5, issued in September 2012

 

L eg a l & w a rr a n t y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 References to othe References otherr document documentation............................ ation.............................................................. .................................................................... .......................................4 .....4 Intended Inten ded Use .................................. .................................................................... .................................................................... ..................................................................4 ................................4

O v e r v i e w S e r v i c e S o f tw tw a r e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5  A c t i o n B u t t o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7  R un Field ............................. ............................... .............. 8 O D C a li li b r a ti t i o n F i e ld ld . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 H o m e F i e ld ld . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2 L e v e l F i e ld ld . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3 T e m p e r a tu t u r e C a li l i b r a ti t i o n F i e ld ld . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4 Q u a li li t y C o n t r o l F i e ld ld . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4 T e m p e r a tu t u r e F i e ld ld . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5 N u m b e r s o f R u n s F i e ld ld . . . . . . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. .. . . 1 5  M e n u D r o p d o w n li s t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 6  S e r v i c e c e n t r e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7 

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Legal & warranty  The content of this manual are the property of ORGENTEC Diagnostika GmbH. Any reproduction 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 modifications may have been carried out since the production of this manual, 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 Diagnostika GmbH is only responsible for the reliability and performance of  the device if the following are strictly observed: 

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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 defective material and assembly. 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 resulting 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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R e f e r e n c e s t o o th t h e r d oc o c u m e n t a t i on on The below topics are described in Instructions in Instructions for use (Use use (Use the Instructions for use together with this service manual). 

General Safety Information

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Basic Information

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Installation

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General Operation

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Calibration

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Software upgrade

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Maintenance

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Technical specifications

Tools required

I nten ded Us e 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 other medical medical evidence evidence to diagnose conditions of the human body. The The Alegria analyser analyser by it-self is i s not diagnostic. The instrument is to be used in medical laboratories. All service of the Alegria analyser is to be carried carr ied out by authorized service personnel. This manual and the other manuals such as Intended Use shall be consulted for an overview. The intention of this service manual is to give an overview of the main parts and systems 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

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Action buttons

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Fields with settable parameter

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Status indicato in dicatorr

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 instrument this will be indicated at the bottom, left corner with the status indicator (disconnected or connected).

Displayed message (popup box) Select the Communication Communication port to be used and click the Connect the Connect serial or serial or Connect  Connect modem if modem if a modem is to be used. If modem is selected s elected a dial connection dialog will appear:

Select the number to be dialled to the Alegria analyser, and if an outside line ton number is required enter so in the outside line field. When the connection is establish established ed the Status indicator will change to connected: connected:

Lower left corner indication field 

N o t e :  You can change c hange these setting from the “Connection “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 “Ch “Change ange to WB # 2”  If wash buffer # 2 is active the button reads “Ch “Change ange 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 module is performed. performed. N O T E : 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 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 checkb checkboxes oxes 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 a nalyse run. To Well: Choose from drop down list which well the dispense needle shall pipette to. Amount [µl]: This is the amount amount in µl that will be pipetted. Range 10-200µl. 10-200µl. Standard needle / Conjugate 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 aspira aspirated ted empty and then filled up with wash buffer. otherwise the wash buffer will be N O T E : Ensure that there is a strip in the correct “Strip position” otherwise 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 aspira aspirated ted empty and then filled up with wash buffer. otherwise the wash buffer will be N O T E : Ensure that there is a strip in the correct “Strip position” otherwise 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 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 amount etc. then push “Add to List” button repeat until all desired transf transfers ers are entered. N o t e : 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 button is located 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 calibration of the OD module.

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

Grey rey fil ilte terr has has to cov cover this part of an optiona ionall str trip ip posit sition. ion. Select strip position the calibration “RUN Field” of theand software. Enter target OD value (OD of  the grey filter) in thein“OD calibra tion Field” press button bu tton the “Calibrate OD”. When ODvalue calibration 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 position. Disp needle vertical position The box is checked when the standard dispensing needle is in its vertical home position. Conj needle vertical The box is checked when wheposition n the t he conjugate conjugate dispensing dispensing needle is in its it s 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 when lid is in closed cl osed position. position.

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Level Field  The Level field indicates the actual fluid levels measured and the present temperature. The explanation / 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 temperature. 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 temperature shown shown in the “Temperature” “Temperature” field in the middle lower part part of the main window. 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 temperature sensor, decrease default value and repeat the procedure described above to temporary or permanently set thethe 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 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 towards this temperature.

When pushed up it starts to regulate towards the default temperature 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 Th e Conn Connec ectt dro rop p down own men menu To Instrument via Serial To Instrument via Modem Settings The settings, pop up dialog, enables the user to select commu c ommunication nication port and type of phone setting (pulse or tone). t one).

The Th e Help Help drop down menu menu Selecting About Alegria SSW… will display the Service Software Version. 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: representative:

Manufactured by: Orgentec Diagnostika GmbH, Carl-Zeiss Carl-Zeiss-Straße -Straße 49, D-55129 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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