nnnnnrnnnn TABLE OF CONTENTS AGE User manual II V20USRUO Table of contents 1Purpose of this manual 52The user interface 521Start the Multiplate system 522Consistency Check ID: 883659
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___________________________________________________________ TABLE OF CONTENTS AGE User manual II V.2.0-US-RUO \n\n \n \n \n\r\n\n\n\n ___________________________________________________________ TABLE OF CONTENTS AGE User manual II V.2.0-US-RUO Table of contents 1 Purpose of this manual ................................................................................................................ 5 2 The user interface ......................................................................................................................... 5 2.1 Start the Multiplate system ........................................................................................................ 5 2.2 Consistency Check ..................................................................................................................... 5 2.3 Keyboard and mouse entries ...................................................................................................... 5 2.4 Main menu .................................................................................................................................. 6 2.4.1 Channel display................................................................................................................... 7 2.4.1.1 Patient identification, test name and test parameter values .................................... 7 2.4.1.2 Scaling bu
2 tton ...................................
tton .......................................................................................................... 9 2.4.1.3 Status icons ........................................................................................................... 10 2.4.1.4 Graphic window ..................................................................................................... 10 2.4.1.5 AUC bar ................................................................................................................. 11 2.4.2 Menu bar ........................................................................................................................... 11 2.4.3 Status bar .......................................................................................................................... 11 2.4.4 Command bar ................................................................................................................... 11 3 Menu options ............................................................................................................................... 12 3.1 Multiplate menu ...................................................................................................................... 12 3.1.1 Channel administration ..................................................................................................... 12 3.1.2 Electronic control...............................................................................................................
3 12 3.1.3 Exit ......................
12 3.1.3 Exit .................................................................................................................................... 15 3.2 Measurement menu ............................................................................................................... 15 3.2.1 Start, Stop and Clear measurements ........................................................................ 15 3.2.2 Identification ...................................................................................................................... 16 3.2.3 Change identification ........................................................................................................ 16 3.2.4 Test selection .................................................................................................................... 16 3.2.5 Electronic pipetting ............................................................................................................ 17 3.3 Tools menu ............................................................................................................................. 20 3.3.1 Start timer .......................................................................................................................... 20 3.3.2 Save screenshot ............................................................................................................... 20 3.3.3 Export measurement values ........................................................
4 ..................................... 20
..................................... 20 3.3.4 Export graphics ................................................................................................................. 21 3.3.5 Liquidtrans ......................................................................................................................... 23 3.4 Print menu .............................................................................................................................. 24 3.4.1 Select printer ..................................................................................................................... 24 3.4.2 Print channels ................................................................................................................... 24 3.4.3 Print screenshot ................................................................................................................ 25 3.4.4 Print test page ................................................................................................................... 25 3.5 Service menu ......................................................................................................................... 26 3.5.1 Calibration ......................................................................................................................... 26 3.5.2 Measurement control (QC-Flag) ....................................................................................... 27 3.5.3 Device configuration ............
5 ........................................
............................................................................................. 29 3.5.3.1 Printing and display options ................................................................................... 29 3.5.3.2 Additional device configurations ............................................................................ 32 3.5.3.3 Signal tones and Other configuration parameters ............................................ 33 ___________________________________________________________ TABLE OF CONTENTS AGE User manual II V.2.0-US-RUO 3.5.4 Change test parameters ................................................................................................... 34 3.5.5 Device status ..................................................................................................................... 36 3.5.6 Show device temperatures ............................................................................................... 37 3.5.7 Language .......................................................................................................................... 37 3.5.8 Change service password ................................................................................................. 37 3.5.9 Change administrator password ....................................................................................... 37 4 Data folder ........................................................................................
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........................................... 38 4.1 Datacontainer ......................................................................................................................... 38 4.2 ElectronicControl .................................................................................................................... 38 4.3 Export ..................................................................................................................................... 38 4.4 Export Graphics ...................................................................................................................... 39 4.5 Graphics ................................................................................................................................. 39 4.6 Screenshots ........................................................................................................................... 39 4.7 XML ........................................................................................................................................ 39 5 Index ............................................................................................................................................. 40 ___________________________________________________________________________ AGE User manual II V.2.0-US-RUO For in vitro research use only Manufacturer: Verum Diagnostica GmbH Reichenbachstr. 27 80469 Munich Germany Phone: +49-89-125556-0
7 Fax: +49-89-125556-11 www.multiplate.
Fax: +49-89-125556-11 www.multiplate.us service@verumdiagnostica.com Version: V.2.0-US-RUO, REF MP0920-US Revised: 2010-11 Software V2.03.11 _______________________________________________________PURPOSE OF THIS MANUAL AGE User manual II V.2.0-US-RUO \r\r This manual contains a detailed description of the Multiplate software. The configuration and use of the software features as well as data storage is explained within. General information, installation and initial start-up, as well as testing instructions for the Multiplatesystem may be found in User Manual I General information and installation guide for the Multiplatesystem. \r The Multiplate system is designed to ensure ergonomic, efficient and safe handling. \r Turn on the power to the system monitor and printer (if a printer is attached). You may now turn on the power to the Multiplate instrument by pushing the blue power button on the right side of the device once inward. The button should stay lit indicating that the power is turned on to the instrument. The Multiplate system will boot up and a sign in screen should appear. Log in with the following credentials: User name multiplate Password multiplate After pressing enter, the Multiplate software program will start up automatically. It is now necessary to wait for the instrument to reach its operating temperature range. After reaching the appropriate temperature (displayed in the status bar)
8 the Multiplate is ready for use. Note: T
the Multiplate is ready for use. Note: The log in password may be changed following the rules of the Windows operating system. ! ! " At each start up of the Multiplate software the Data container is checked for consistency (i.e. scanned to detect any failures of the hardware). #$ %&&\r Entries may be made by keyboard and/or computer mouse. Menu commands may be selected by means of shortcuts, i.e. characters, function-keys, numbers or respective mouse buttons. __________________________________________________________ THE USER INTERFACE AGE User manual II V.2.0-US-RUO '\r After the instrument has booted up, the main menu will appear automatically. The structure of the main menu is as follows: Table 2.1: Structure of the main menu Screen area Function 1 Menu bar Contains several commands and drop down menus. 2 Status bar Displays the temperature and status of the measurement block as well as the date and time. 3 Command bar Contains the essential commands for the use of the Multiplate ® . 4 Channel display Contains data, graphics, patient sample and test identification for each channel. Fig. 2.1: Structure of the main menu __________________________________________________________ THE USER INTERFACE AGE User manual II V.2.0-US-RUO ' !& Every channel consists of an information area and a graphic window (Fig. 2.2). Fig. 2.2: Channel window '
9 & (&
& (&)\r The upper portion of each channel window includes the patient identification, test name, date, start time and runtime of the measurement (Fig. 2.2 and Fig. 2.3, red marking). In addition, the following aggregation parameter values are displayed to quantify the measured signal: AUC = Area under the aggregation curve Aggregation = Increase of impedance during analysisVelocity = Maximum slope of aggregationAUC is the recommended parameter for the evaluation and interpretation of the test measurement. Note: The results are presented as the arithmetic mean of the double measurement within each test cell. Patient i dentification, test name and test parameter values Scaling button Status icon Graphic window Channel number AUC bar __________________________________________________________ THE USER INTERFACE AGE User manual II V.2.0-US-RUO Fig. 2.3: Runtime, normal value and QC parameters AUC parameter Upper and lower limits of normal ranges are displayed in brackets next to the AUC value (Fig. 2.3, blue marking) of the active measurement. They may also be displayed in the AUC bar as a dark green area (see chapter 2.4.1.5 AUC bar). In previous software versions the unit for the parameter "Area Under the Curve" (AUC) was [AU*min]. The use of this unit designation is inconvenient, as results � 1000 do not fit result reporting conventions typically used in the diagnostics field. Additionally the use of a four figure re
10 porting structure does not fit with the
porting structure does not fit with the statistical accuracy of the AUC parameter (CV is usually between 6-10%). Therefore a new reporting unit for AUC was introduced to simplify result reporting. The new unit designation is simply [U] or Units (Fig. 2.3). 1 U = 10 AU*min Using the new unit [U], Multiplate results are reported in more common ranges of around 100 U. However, for those users happy to continue using the old unit of [AU*min], it will still be available. Switching between the units is possible through the Multiplate Service menu -� Device configuration (see chapter 3.5.3.2 Additional device configurations, item Display format of the AUC parameter). Normal values for the AUC parameter for a specific test may be defined in the Change test parameters feature of the Service drop down menu. QC parameters Runtime Normal value __________________________________________________________ THE USER INTERFACE AGE User manual II V.2.0-US-RUO Aggregation and Velocity For clinical result reporting we recommend the use of the AUC parameter. The parameters Aggregation and Velocity are labelled for research use only (RUO, Fig. 2.4, red marking). Fig. 2.4: Parameters for research use only Quality control parameters of the aggregation curves The Quality Control (QC) parameters correlation coefficient (CC ) and deviation from mean (DIF) are calculated and displayed in the bottom row . This serves as
11 a control for the correlation of the tw
a control for the correlation of the two measurements performed in each test cell (see Fig. 2.5 and chapter 3.5.2 Measuremen t control (QC-Flag)). Fig. 2.5: Quality control parameters The CC is calculated according to Pearson, based on the data that is recorded during the measurement by each single sensor pair in the test cell. The deviation of the two single measurements from their mean is displayed as a percent. ' *%\r The axis of ordinates is adjustable to 4 scaling levels: 50, 75, 100 and 200 Aggregation Units [AU]. By selecting the AU button the scale changes to the next sequential scaling level (Fig. 2.6). The scaling function allows the optimization of aggregation curves with low aggregation responses (Level 50 / 75 AU) and the complete display of curves with high aggregation (Level 100 / 200 AU). a b c d Fig. 2.6: Different scaling levels The scaling button is preset to 200 AU, to improve the assessment of curves with higher aggregation signals. _________________________________________________________ THE USER INTERFACE AGE 10 User manual II V.2.0-US-RUO The scaling for each channel may be changed individually or, by selecting the All button above the graphic window of the first channel, all channels may be changed simultaneously. ' #\r Table 2.2: Explanations of the status icons The channel is ready for a new measurement The channel is locked The measurement is running Printing the measurement Ple
12 ase wait The measurement has been prin
ase wait The measurement has been printed Saving the data of the measurement A printing problem occurred The measurement is complete and data is saved ' '+ ,&, The results of the measurement are displayed in the graphic window. Either two individual curves (Fig. 2.7a) or an averaged area curve (Fig. 2.7b) of the double measurement may be displayed. The filled area curve reflects the mean value of the double measurements. a b Fig. 2.7: Curve (a) and area curve (b) display formats of the aggregation signal You may toggle between the display formats at any time by pressing function key F9.33;É; selecting button F9: Curve mode on the monitor screen using the computer mouse; or choosing item 6 Show curves as an area in the drop down menu Device configuration (see chapter 3.5.3 Device configuration, Fig. 3.37). The double measurement statistics deviation from the mean and correlation coefficient are calculated by the software (see chapter 3.5.2 Measurement control (QC-Flag)). _________________________________________________________ THE USER INTERFACE AGE 11 User manual II V.2.0-US-RUO ' -!% An AUC bar is present in the graphic window of each channel. This offers a convenient way of comparing the present AUC result with a programmed reference range. Within the AUC bar an additional result box representing the reference range may be depicted in dark green. A black bar within the AUC bar indicates the actual AUC result of the current m
13 easurement (Fig. 2.8a and b). At the sta
easurement (Fig. 2.8a and b). At the start of each measurement the black bar appears at the bottom of the AUC bar and rises according to the strength of the aggregation signal. A result reflecting a normal AUC response will place the black bar within the green zone. A black bar located above the green zone represents hyperaggregation and a black bar below the green zone (Fig. 2.8b) reflects platelet dysfunction or inhibition of aggregation. a b Fig. 2.8a: Normal range; b: Aggregation below the normal range For further information on the range of the AUC bar see Maximum value for the AUC area bar in chapter 3.5.3.2 Additional device configurations. ' \r% The menu bar consists of drop down menus: Multiplate, Measurement, Tools, Print and Service. For further information on these features please see chapter 3 Menu options. ' #\r% The status bar in the main menu reflects the current temperature of the measurement area and indicates whether the temperature is in or out of the acceptable operating range. If the user is attempting to start a test and the temperature is out of range, the user is prompted whether to proceed with the test or wait for the temperature to reach the operating temperature. The status bar also displays any errors or service messages for the user. In addition, the current date and time are located on the right side of the status bar. ' '!&% The command bar contains various functions for the Multiplate system. The functions of the comm
14 and buttons (page 6, Table 2.1 and Fig.
and buttons (page 6, Table 2.1 and Fig. 2.1) may also be selected within the drop down menus in the menu bar, by typing the letter (T), or a specific function key (F1-F9). Upper end of normal range Lower end of normal range Current measurement resultAUC bar _________________________________________________________ THE USER INTERFACE AGE 12 User manual II V.2.0-US-RUO \r# .\r/\r Fig. 3.1: Commands in the Multiplate menu # !& Within the Channel administration feature, individual channels may be locked or unlocked. Locked channels are identified with an icon and a red cross in the graphic window. A locked channel will be automatically excluded when tests are performed using the automated electronic pipette function. # An electronic control test may be performed at anytime to ensure the proper function of the measurement systems electronic components. The electronic control is a measurement of a fixed internal resistor that is connected to the park positions of the 5 sensor cables. The five channels with their double sensors are tested and the actual values are compared to a reference range defined by the manufacturer. It is recommended to perform an electronic control on a regular basis in accordance with your institutions policies and procedures (e.g. the beginning of each shift). Please ensure that all sensor cables are plugged into the park position ( Fig. 3.2) and that the system temper
15 ature has reached the operating range o
ature has reached the operating range of 36-38°C before starting the electronic control. Select the menu Multiplate � Electronic control to start the test. Fig. 3.2: Park position of the sensor cable If the Multiplate temperature is out of the recommended range and / or the device has been running for a time period shorter than specified by the manufacturer ( 20 minutes), a message box will appear advising the user not to run the electronic control under those conditions (Fig. 3.3 and Fig. 3.4). ______________________________________________________________ MENU OPTIONS AGE 13 User manual II V.2.0-US-RUO Fig. 3.3: Safety notice - too short ( 20 minutes) waiting time from the start of the Multiplate system Fig. 3.4: Safety notice - Multiplate® temperature out of the recommended range If under certain circumstances (e.g. the software program was closed by mistake but the instrument temperature is in operating range) the user decides to ignore the warning and proceed with the test, he may press the Yes button and proceed. To perform the electronic control, select the Start electronic control button (Fig. 3.5). Fig. 3.5: Starting window of the electronic control ______________________________________________________________ MENU OPTIONS AGE 14 User manual II V.2.0-US-RUO After running the electronic control a message box will appear containing the Results of the electronic control (Fig. 3.6). This window will indicat
16 e those channels that are within ran ge
e those channels that are within ran ge and those channels that failed the test. If the results fail for any of the channels, perform a new electronic control test. If the results continue to fail, contact your local dis tributor or the manufacturer. Fig. 3.6: Message box with the results of a successful electronic control If any of the channels fail to pass the control test due to a short circuit or a bad electronic contact a second message box informs the user o f the channels outside the reference range (Fig. 3.7). The user is advised to change the sensor cables for the faulty channels and to ensure the proper contact of the new cables before repeating the electronic control. The user is also advis ed to lock any defective channels (i.e. channels with a short circuit or bad electronic contact) from further use by pressing the button Lock faulty channels. Fig. 3.7: Example of a message box with a bad result of the electronic control For a printout of the electronic control results select Print results. Every electronic control result is saved automatically (see chapter 4 Data folder). ______________________________________________________________ MENU OPTIONS AGE 15 User manual II V.2.0-US-RUO # #0 To exit the Multiplate software program , choose the command exit or click the button at the top right in the main menu . After confirmation by selecting Yes in the security dialogue box (Fig. 3.8) the Multiplate software will
17 shut down automatically. Fig. 3.8: Dia
shut down automatically. Fig. 3.8: Dialogue box confirmation to exit the Multiplate ® software # .\r/\r Fig. 3.9: Commands in the "Measurement" menu In this menu you may choose from several commands to perform, edit or identify measurements. Testing may be conducted using manual pipetting or by selecting the automated electronic pipetting feature. # ..(..&.!.\r After choosing one of the following commands from the Measurement drop down menu: Start (or click button F3: Start test), Stop, or Clear (or click button F7: Clear channel) the appropriate dialogue box will open (Fig. 3.10). The Start command is reserved for testing with a manual pipette. The command Stop may be used when a channel must be stopped before the test time is complete. a b c Fig. 3.10: Dialogue boxes of commands "Start" (a), "Stop" (b) and "Clear" (c) ______________________________________________________________ MENU OPTIONS AGE 16 User manual II V.2.0-US-RUO Select the channel(s) (1-5) where the respective command shall be executed by ticking the box next to each channel or by entering the corresponding number using the keyboard. To apply a command to all channels, tick the last box (6). To execute the command, click on the respective command button (Start / Stop / Clear) or press the enter key. # \n& To name or identify a running test choose the command Identification or select button F4: Enter ID. Selec
18 t the channel(s) for each identification
t the channel(s) for each identification and enter the patients name or ID information (Fig. 3.11). When finished entering the ID, press the Identification button and the entry will be assigned to the information area of each channel that was selected. Selecting theLast ID-button will automatically recall and enter the last patient information that was programmed. The entered patient ID information will be added to the tests saved file name. Fig. 3.11: Identification dialogue window # #!*& To change a patient ID during or after a test, select the command Change ID (or click button F5: Change ID). Fig. 3.12: Change ID dialogue window Each channels entry may be changed individually (Fig. 3.12). After selecting the channel(s) and making the necessary changes, click the button Identification to confirm and apply the changes. # ' To assign a test while measuring in the manual mode, select the command test select (or click the button T: Test selection). Every test is saved as a file (see chapter 4 Data folder) and the patient ID is added to the tests file name. Because the operating system (Windows) does not accept all characters within a file name, the following 12 characters should not be used when identifying a test or patient sample: /, \, ?, ", ', |, :, *, , .33;É, return and tabulator. ______________________________________________________________ MENU OPTIONS AGE 17 User manual II V.2.0-US-R
19 UO Select the channel(s) by clicking t
UO Select the channel(s) by clicking the corresponding box(es) and choose the appropriate test name (Fig. 3.13) from the drop down test menu. Select a test name from the list by highlighting it. After confirming the entry, the selected test is assigned and will appear in the channel information area of each selected channel. The test name will be added automatically to the file name of each channels saved test data file. Fig. 3.13: Dialogue box for assigning a test to a channel # - * The electronic pipetting system simplifies and standardizes the testing process in regard to sample handling, sample assignment and pipetting. The user is guided through the testing steps by instructions that appear in a dialogue box. The Electronic pipetting mode may be chosen in the Measurement drop down menu (or by selecting the button F1: Auto pipette). When electronic pipetting is selected, a dialogue box for the measurement procedure will appear with specific step by step instructions for the testing process (Fig. 3.14). Fig. 3.14: Electronic pipetting dialogue window Enter the patient ID(s) and select the specific test for each channel to be run. Confirm the entries by pressing the Start auto-pipette button. This corresponds to the identification and test assignment in the manual pipetting mode. Only channels with an assigned ID and test will start a measurement. The patient ID is limited to 135 characters. If a patient ID has already been entered after opening the M
20 ultiplate software, it is possible to co
ultiplate software, it is possible to copy the last ID for the next measurement by clicking the Last ID button (Fig. 3.14, red marking). By ______________________________________________________________ MENU OPTIONS AGE 18 User manual II V.2.0-US-RUO selecting For all tests the first ID is copied into all five of the fields. To re-use the ID from the previous field click the button Get ID. Only free channels may be selected and programmed for testing; therefore, the maximum number of tests that may be running at one time is limited to 5. After a test has finished, the channel may be cleared and a new test may be programmed and started while the other channels are still running. After clicking the Start auto-pipette button, the user is asked to insert a test cell into the measuring position and connect the sensor cables to the test cell for all channels that have been programmed for testing. After confirming completion of this step, the dialogue window Current pipetting program opens (Fig. 3.15). Fig. 3.15: Dialogue window Current pipetting program The operation of the pipette is displayed in the upper portion of this window. In the middle portion of the window is a red box where the specific pipetting instructions for the current test step are explained in detail. The lower portion of the window displays the pipetting steps in tabular form for each programmed channel. A green arrow indicates the current pipette step (Fig. 3.15, orange circle). Remaining steps are i
21 dentified with blue dots and completed s
dentified with blue dots and completed steps display a check mark to the left. To execute the current pipetting step, press the blue Start button on the electronic pipette. Once a step is completed the next step is automatically displayed. Please follow all pipetting steps diligently, paying close attention to the following message: Initialisation of the pipette Please do not tap any key on the pipette during this time., that appears in a red box after every pipette step carried out (Fig. 3.16). Fig. 3.16: Initialisation of the pipette ______________________________________________________________ MENU OPTIONS AGE 19 User manual II V.2.0-US-RUO If any key is pressed (including ejecting the tip) during this time, the initialization is disrupted and the pipette may aspirate an incorrect volume during the following step. The incubation time for each test is displayed as Incubation time with a clock that counts down. After the incubation time has elapsed, an audible signal prompts the user to proceed to the next step. After pipetting the platelet agonist into the test cell, the measurement will begin automatically. An error message for the current pipetting program will be displayed in red at the bottom of the window (Fig. 3.17). When a pipette step is not possible (e.g. when the incubation time or the measurement has already been started), an audible signal is heard and an explanation appears in red letters at the bottom of the window. Fig. 3.17: Current pipetting p
22 rogram To cancel the current pipetting
rogram To cancel the current pipetting program for all programmed channels, close the window by clicking the button in the top right corner of the window. Do not push any button on the pipette during initialization of the pipette, as this may interfere with proper communication to the pipette. ______________________________________________________________ MENU OPTIONS AGE 20 User manual II V.2.0-US-RUO # #. /\r Fig. 3.18: Commands in the Tools menu # # This command is useful when pipetting manually on the Multiplate® system. Select Start Timer (or click the button F2: Start Timer) to initiate the standardized 3 minute incubation step before proceeding to the next step. An audible signal indicates when the incubation is complete. # # ) An image of the actual test screen may be saved by using the command Save screenshot or selecting the button F8: Screenshot. Enter a file name for the screenshot image and confirm. An image file will be saved to the data folder: C:\Documents and Settings\ multiplate\Multiplate\Data\Screenshots. The screenshot contains an image of the main screen with all 5 test channels. # # #0\r)\r To summarize the results of several measurements in one table the measurements may be exported as XML (Ex tensible M arkup L anguage)-files. Afterwards the data can be edited in spread sheets, like Microsoft-Excel. The export function may be used by selecting the command Export measurement v
23 alues. In the window Export measureme
alues. In the window Export measurements (Fig. 3.19 ) a start and an end date must be defined. A targeted nu mber of measurements per export file must then be chosen. This will depend on the version of MS Office available. Note: The calendar is displayed in the language selected in the regional settings of the Windows operating system. Fig. 3.19: Export measurements With each export request four XML-files are generated: Aggregation, Raw data Sensor 1, Raw data Sensor 2 and Velocity. ______________________________________________________________ MENU OPTIONS AGE 21 User manual II V.2.0-US-RUO For example, if the Maximum 250 measurements in each export file option is chosen, the four files previously mentioned will be generated for each of the 250 measurements. Clicking the button Export selected period will export the corresponding data and the screen will display the words Export successful ( Fig. 3.20, red circle). If successful, exit the window by clicking the button Close. The exported files may be found in the Data folder on the desktop (see chapter 4 Data folder). Fig. 3.20: Export measurements # # '0* In addition to test data, test graphics may also be exported. Using the command Export graphics, graphic files of previously recorded measurements may be reprocessed and redisplayed in any of the available aggregation unit zoom factors. Select the period that shall be exported by defining the start and the end date
24 s in the opening window (Fig. 3.21). N
s in the opening window (Fig. 3.21). Note: The calendar is displayed in the language selected in the regional settings of the Windows operating system. Fig. 3.21: Export graphics ______________________________________________________________ MENU OPTIONS AGE 22 User manual II V.2.0-US-RUO Select the zoom factor in which the values shall be represented (Fig. 3.22, red circle). Begin exporting by clicking on the button Export selected period. Fig. 3.22: Zoom factor When successful Export successful will appear in the window (Fig. 3.23, red circle). Exit the window by clicking the Close button. The exported graphic files may be found in the Data folder on the desktop (see chapter 4 Data folder). Fig. 3.23: Export successful ______________________________________________________________ MENU OPTIONS AGE 23 User manual II V.2.0-US-RUO # # - 1\r& The feature Liquidtrans allows the user to reconstitute reagents and to prepare reagent aliquots with the electronic pipette. Enter the required volume (at least 10 µl) to be dispensed in the edit window and then click the Start Liquidtrans button to begin (Fig. 3.24). Fig. 3.24: Entering the volume The pipette is capable of transferring volumes up to 300 µl in one step. If the requested volume is greater than 300 µl incremental steps must be performed. For example, a volume of 1000 µl will be transferred in four steps as 300+300+300+100 µl (Fig. 3.25). Fig. 3.25:
25 Edit field for the requested volume, pen
Edit field for the requested volume, pending steps are displayed in the red box An audible signal indicates the completion of the total task. Upon completion, the Liquidtrans program is ready to repeat the same task again unless the volume is changed. If a new volume is to be transferred, close the Liquidtrans window by pressing the button at the top right of the window and then restart the Liquidtrans program. ______________________________________________________________ MENU OPTIONS AGE 24 User manual II V.2.0-US-RUO # '. /\r Fig. 3.26: Commands in the print menu # ' After installing a printer, the user must select the printer in the software in order for the software to recognize the printer. Use the command Select printer (Fig. 3.26). This feature is restricted for use with the service password. To select a printer, click on the arrow in the drop down menu located next to Selected printer: ( Fig. 3.27). All installed printers are listed. Click on the printer you wish to select. Fig. 3.27: Select printer After selecting the printer, choose Color print or Black and white print according to the selectedprinter. Confirm your selection by clicking the Accept button (Fig. 3.27). # ' The user may print test results for specific channels by selecting Print channels in the print menu or clicking on button F6: Print. The dialogue box Print measurements will appear. Select the channel(s) to be printed. When
26 finished click on the Print button a
finished click on the Print button at the bottom. The test results for the selected channel(s) will now be printed (Fig. 3.28). Fig. 3.28: Dialogue window "Print measurement" The measurement results are printed sequentially in a vertical format. Each graph in the printout will reflect the scale at which the corresponding test was run (Fig. 3.29, red circle). ______________________________________________________________ MENU OPTIONS AGE 25 User manual II V.2.0-US-RUO Fig. 3.29: Example printout for one channel As soon as the user clicks the print button, the software automatically creates a screenshot of the main screen. This screenshot is automatically saved in the Screenshots folder and may be retrieved from the file path C:\Documents and Settings\multiplate\Multiplate\Data\Screenshots or in the Data folder on the computer desktop (see chapter 4 Data folder). Refer to chapter 3.5.3.1 Printing and display options for an explanation of special printing options. # ' # If an exact printout of the computer screen is desired, the user may print a screenshot. Select the command Print screenshot. The screenshot will be printed in a horizontal format displaying the results and graphs for all channels as displayed on the computer screen. # ' ' * To verify the proper installation of an attached printer or status of the ink or toner cartridge, it might be useful to print a test page by selecting the command Print test page (Fig. 3.30).
27 Fig. 3.30: Example test page printout
Fig. 3.30: Example test page printout ______________________________________________________________ MENU OPTIONS AGE 26 User manual II V.2.0-US-RUO # -.) /\r Fig. 3.31: Commands in the Service menu Some commands in the Service menu are restricted for use only with the service password (Fig. 3.32). When necessary, this password may be obtained from the manufacturer or local sales distributor. Fig. 3.32: Dialogue window Service password # - !% Caution: Changes to any item in the calibration menu are restricted to the manufacturer or approved service provider. ______________________________________________________________ MENU OPTIONS AGE 27 User manual II V.2.0-US-RUO # - \r 23!45*6 The precision and correlation of the double measurements within a test cell may be controlled electronically. In the menu window Measurement control (Fig. 3.33) the measurement control function is activated by default. A low threshold of 30 AU is set for the internal QC of the double measurements. Values below 30 AU are not subject to the automatic QC. This threshold value may be manually adjusted and included into the measurement control feature. Results below the new threshold setpoint will not be subject to the automatic QC. Because a higher relative deviation of the two curves at low aggregation results is expected, it is not suggested to apply this QC feature to measurements with aggregation results
28 30 AU. Fig. 3.33: Dialogue window Meas
30 AU. Fig. 3.33: Dialogue window Measurement control The automatic measurement quality control consists of two criteria: the correlation coefficient of the two single measurements (CC) and the deviation from mean or DIF (Fig. 3.34, red circle). The default setting for the CC is 0.98 and for the DIF is 20% maximum deviation from mean. These values may be adjusted individually. Analyses of completed tests that fail to pass one or both of the criteria will be identified by a QC flag (pop up message) in the graphic window (Fig. 3.34). Fig. 3.34: Measurement out of the specified criteria; marked with a QC flag By clicking on the pop-up QC message with the mouse, a QC-information window will appear on the screen (Fig. 3.35) and the graphic display mode toggles to the curve mode. ______________________________________________________________ MENU OPTIONS AGE 28 User manual II V.2.0-US-RUO Fig. 3.35: QC-information After reviewing information about the results and the failed control parameters, the user may decide whether or not to delete the measurement. If the user decides not to delete the measurement thereby accepting the result, he may click the no button. The measurement will be recorded and the term QC flag will be added to both the patient ID and the filename. If the user decides to delete the measurement by clicking Yes, the channel will be cleared but the measurement will be saved and the term deleted placed in front of the filename.Correlation and precisi
29 on results are displayed in the printout
on results are displayed in the printout of the measurements, when selected in the device configurations feature of the service menu (Add information on the printout, see chapter 3.5.3.1 Printing and display options). An additional QC-flag-message, QC flag: Decreasing curve may appear (Fig. 3.36). A decreasing curve may result if the sample diluent (NaCl) was not preheated. If such an error occurs, the error message will appear directly above the curve during the measurement (Fig. 3.36a). After the measurement is complete, the error message will appear in the Patient ID edit field. The AUC, aggregation and velocity parameters will display zero values (Fig. 3.36b). Fig. 3.36: QC-flag: decreasing curve; a: during the measurement, b: after the measurement a b ______________________________________________________________ MENU OPTIONS AGE 29 User manual II V.2.0-US-RUO # - #7) *\r After selecting the option Device configuration the following window appears: Fig. 3.37: Dialogue window "Device configuration" In the menu device configuration the following information may be selected or modified: # - # *&& The measurement display and printout may be modified to reflect various configurations. Options one through four of the device configuration window relate to the configuration of the graphic window. By clicking each corresponding box and activating the first two options, the raw data from the measurements will be
30 displayed on the screen and the printou
displayed on the screen and the printout as a blue or red colored shadow above the corresponding curve ( Fig. 3.38). Fig. 3.38: Raw data in the graphic window on the screen When options 3 and 4 are activated, the graphic window and the printout will display a grid pattern. ______________________________________________________________ MENU OPTIONS AGE 30 User manual II V.2.0-US-RUO By selecting option 5 Add. information on the printout ( Fig. 3.39), the printout will display the single values of the aggregation (Ag), velocity (Vel), and the aberration from the mean (Abbr. from mean) as well as raw data from the beginning (Base) and end of the measurement (End) ( Fig. 3.40). The values for the AUC parameter are always presented in units (U). Fig. 3.39: Printing option Additional information on the printout Fig. 3.40: Example of a Multiplate printout including Base and End raw data of the measurement Item 6 Show curves as an area (Fig. 3.41) will change the display mode from two individual aggregation curves to one averaged area curve (see chapter 2.4.1.4 Graphic w indow). Fig. 3.41: Printing option Show curves as an areaWhen item 7 Print only the AUC (Fig. 3.42) is selected, the printout will only contain the AUC parameter. The results of the aggregation and velocity parameters will not appear (Fig. 3.43). However, the auto matically saved graphics in the graphics folder will still contain all parameters of the measurement
31 (Fig. 3.44). Fig. 3.42: Printing option
(Fig. 3.44). Fig. 3.42: Printing option Print only the AUC ______________________________________________________________ MENU OPTIONS AGE 31 User manual II V.2.0-US-RUO Fig. 3.43: Printout without the results (mean value) of the aggregation and velocity parameters Fig. 3.44: Automatically saved graphic of a measurement The screenshots which are automatically saved during the printing process are not named with the patient ID only with the date and the time of the measurement. If you want to hav e a named file choose no. 8 Change screenshot ID at the device configuration (Fig. 3.45). Fig. 3.45: Printing option Change screenshot ID After pressing the F6: Print.33;á function key, a pop up window will open where you may fill in any user defined identification (Fig. 3.46). When finished, click the Accept button to save the named screenshot in the Screenshots folder located in the Data folder on the computer desktop. Fig. 3.46: Identify screenshot If you choose Cancel no screenshot will be saved . ______________________________________________________________ MENU OPTIONS AGE 32 User manual II V.2.0-US-RUO # - # &&&) *\r Maximum measurement duration The default measurement duration for the standard test protocols is 6 minutes. The duration may be adjusted from 3 to 30 minutes in the Device configuration option of the service menu (Fig. 3.47). If invalid values ( 3 or .33;É
32 30 min) are entered in the Maximum me
30 min) are entered in the Maximum measurement duration (3-30 min) box, the user is asked to correct the input. Laboratory ID A Laboratory ID may be entered in the dialogue window Device configuration (Fig. 3.47), and will appear on every test printout. Fig. 3.47: Further device configurations Timer runtime The runtime of the timer, which can be started from the Tools menu, may be modified here. The default runtime of the timer is 180 seconds (Fig. 3.47). Specified temperature and ranges The default setting of the specified temperature is 37°C. The tolerance range is 37±1°C (Fig. 3.47). These ranges are specified in the calibration menu and should not be changed. Gain This value should not be adjusted by the user. Only the manufacturer or authorized service representative may change this parameter. Turn off heating The operating temperature should not be changed. If the instruments operating temperature exceeds 42°C (Fig. 3.47), the software automatically turns off the heating to prevent damage to the electronic parts. Max. value for the AUC area bar The default maximum value for the AUC bar is 180 U (i.e.1800 AU*min) (Fig. 3.47). This setting may be modified here. Graphics export format With this option the user may select the image format for graphic export files. The user may choose between the formats PNG (Portable Network Graphics) and JPG (Joint Photographic Experts Group) (Fig. 3.47). ______________________________________________________________ MENU OP
33 TIONS AGE 33 User ma
TIONS AGE 33 User manual II V.2.0-US-RUO Display format of the AUC parameter The user may choose to display the AUC value in Units [U] or [AU*min] through this option (Fig. 3.47). Note: 1 U = 10 AU*min. # - # #.*/&.8 *\r/ Signal tones The signal tone may be generated by a beeper integrated in the mainboard or by the primary audio device. The default setting of the mainboard, should not be changed. To ensure that the selected signal tone is audible, click the button Test the signal tone (Fig. 3.48). Other configuration parameters The item other configuration parameters displays the waiting time until an internal electronic control may be conducted. The default time is 20 minutes (Fig. 3.48 ) and should not be adjusted. This should allow ample time for the Multiplate to reach its operating temperature of 37°C before running an electronic quality control test. Fig. 3.48: Signal tones and Other configuration parameters ______________________________________________________________ MENU OPTIONS AGE 34 User manual II V.2.0-US-RUO # - '!* After selection of the command Change test parameters the following dialogue window appears: Fig. 3.49: Dialogue window "Change test parameters"New tests or individual test parameters of existing tests for use in the electronic pipetting mode maybe programmed in this dialogue window (Fig. 3.49, Add a test). After selecting a test
34 from the List of available tests (Fig
from the List of available tests (Fig. 3.49), the corresponding parameters of the highlighted test are displayed on the right side of the dialogue window (Fig. 3.49). A maximum of three pipette steps before and/or after an incubation step may be included into a test program by entering the volume in µl and the name of the liquid(s). Blank steps with no volume value added or those with a 0 will be skipped during the execution of the test. Note: If the volume is 0 µl for steps 4-6 the test cannot be executed. A volume � 0 µl has to be defined for at least one of these steps. The incubation time (default 180 sec.) and the start time of the measurement in relation to the incubation time may be adjusted. If the start time of the measurement is set to 0 seconds, the measurement will begin immediately after the last pipetting step of the test procedure. The pipette speed may be adjusted, though it is not recommended to deviate from the default setting. Normal ranges for each parameter (Aggregation [AU], Velocity [AU/min] and Area under the curve (AUC) [U / AU*min]) may be applied. New entries or modifications to a test are not saved until clicking the button Save test data. ______________________________________________________________ MENU OPTIONS AGE 35 User manual II V.2.0-US-RUO If the user wishes to have normal values for any of the parameters displayed on the screen and in the printout, the corresponding box(es) for those values must be selected (Fi
35 g. 3.49, bottom right). In the example,
g. 3.49, bottom right). In the example, by selecting the option Show normal value for Agg, the normal values appear in brackets after the current aggregation value [AU] (Fig. 3.50, red circle) and within the graphic window as horizontal green lines (Fig. 3.50). Fig. 3.50: Upper and lower limit of the normal range for AUIf the option Show normal value for AUC is selected, the values are displayed in brackets next to the current AUC value (U) and vertically on the left side of the graphic window as a dark green bar (Fig. 3.51 and chapter 2.4.1.1 Patient identification, test name and test parameter ). Note: When programming a new test, normal values must be entered with the units AU*min. If the AUC is to be displayed in U, the software automatically converts the AU*min values into Units (U). Because 1U = 10 AU*min, normal range values that have been determined in U must be entered by adding a zero (multiplying by 10) to the values to convert them into AU*min values. Fig. 3.51: Upper and lower limit of the normal range for AU*min The box Use this test (Fig. 3.49, bottom right) must be marked in order for the highlighted tests name to appear in the drop down test menu when using the automatic pipette program and in the drop down menu All available tests under Test selection (see chapter 3.2.4 Test selection). ______________________________________________________________ MENU OPTIONS AGE 36 User manual II V.2.0-US-RUO # - -7) \r The dialogue
36 window Device status displays the curr
window Device status displays the current measuring values as raw data values, values with calibration factors, or values with calibration and correction factors (Fig. 3.52) depending on the selection from the drop down menu Show data as:. a b c Fig. 3.52: Device status a: Raw data without calibration; b: Data with calibration factors; c: Data with calibration and correction factors; ______________________________________________________________ MENU OPTIONS AGE 37 User manual II V.2.0-US-RUO # - 9,&) \r The temperature menu displays the real time temperature status of three temperature sensors located in the pre warming area, as well as the internal temperature of the circuit board (Fig. 3.53). Fig. 3.53: Dialogue window "Device temperatures" # - : *\r* The user may select a display language from the 9 user interface languages in the Language configuration dialogue box. By selecting the language of choice and clicking the Accept button (Fig. 3.54), the new language is activated immediately. I t is not necessary to restart the Multiplate software for the change to take effect. Fig. 3.54: Language configuration # - ;!*) ,& Changing the service password is not recommended by the manufacturer. # - !*&,& Changing the administrator password is not recommended by the manufacturer. _______________________________________________________________ DATA FOLDER AGE 38
37 User manual II V.2.0-US-RUO
User manual II V.2.0-US-RUO 7& Measurement data is automatically saved in both graphic and XML data files. The data is located in: C:\DocumentsandSettings\multiplate\Multiplate\Data or in the folder Data on the desktop (Fig. 4.1). Fig. 4.1: Path to saved data The Data folder contains the following subfolders. ' .7 / The "Datacontainer" is a feature of the internal structure of the Multiplate software and represents a collection of data that contains information on all measurements ever conducted on the device. ' . !. Electronic control test results are saved in the Electronic Control subfolder in the .txt file format. They are automatically sorted into subfolders identified by date. ' #.0. Exported data are saved to the Export subfolder (Fig. 4.2). Fig. 4.2: Storage location of exported measurementsExport files contain all information for every measurement (test name, patient ID, date, test parameters etc.). _______________________________________________________________ DATA FOLDER AGE 39 User manual II V.2.0-US-RUO ' '.0+ . Exported graphics are automatically saved as PNG files in the subfolder Export Graphics (Fig. 4.3). Fig. 4.3: Storage location of exported data ' -.+ . In the subfolder Graphics each measurement is saved as a graphic file that also includes the values for the determined parameters. The file name consists of time of measurement, channel, patient ID a
38 nd test name. ' 9. / All scr
nd test name. ' 9. / All screenshots that have been saved may be found in the Screenshots subfolder (Fig. 4.4). The user may also refer to chapters 3.3.2 Save screenshot and 3.4.2 Print channels. Fig. 4.4: Subfolder Screenshots for automatically saved screenshots ' :.= / The XML data subfolder (Fig. 4.1) contains the complete information of each Multiplatemeasurement. Each XML file represents one test. The file format XML allows for easy importing to spreadsheet-programs such as Microsoft Excel or OpenOffice scalc. _____________________________________________________________________ INDEX AGE 40 User manual II V.2.0-US-RUO \n&0 AUC bar ......................................................... 11 AUC parameter ................................................ 8 Calibration...................................................... 26 Change identification ..................................... 16 Change service password ............................. 37 Change test parameters ................................ 34 Channel administration .................................. 12 Channel display ............................................... 7 Command bar ................................................ 11 Consistency Check .......................................... 5 Data folder ..................................................... 38 Device configuration ...................................... 29 Device status ................................................. 36 De
39 vice temperatures ......................
vice temperatures ..................................... 37 Display format of the AUC parameter ........... 33 Display of aggregation curve ......................... 10 Electronic control ........................................... 12 Electronic pipetting ........................................ 17 Export graphics .............................................. 21 Export measurement values .......................... 20 Gain ............................................................... 32 Graphic window ............................................. 10 Graphics export format .................................. 32 Identification .................................................. 16 Keyboard and mouse entries .......................... 5 Laboratory ID ................................................. 32 Language ....................................................... 37 Liquidtrans ..................................................... 23 Main menu ....................................................... 6 Max. value for the AUC area bar ................... 32 Measurement control ........................... 9, 10, 27 Measurement duration .................................. 32 Measurement menu ...................................... 15 Menu bar ....................................................... 11 Menu options ................................................ 12 Multiplate menu ............................................. 12 Normal value ............................................. 8, 35 Patient ID .........
40 ........................................
............................................. 16 Pipette orders ................................................ 18 Print channels ............................................... 24 Print menu ..................................................... 24 Print screenshot ............................................ 25 Print test page ............................................... 25 Printing and display options .......................... 29 QC-Flag .............................................. 9, 10, 27 Save screenshot ........................................... 20 Scaling ............................................................ 9 Select printer ................................................. 24 Service menu ................................................ 26 Service password .......................................... 26 Specified temperature and ranges ................ 32 Start the Multiplate system ............................ 5 Start timer ..................................................... 20 Status bar ...................................................... 11 Status icons .................................................. 10 Test selection ................................................ 16 Timer runtime ................................................ 32 Tools menu ................................................... 20 Turn off heating ............................................. 32 User interface .................................................. 5 XML .......................................