UM_SW_THEODORICO_38A1A.pdf

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THEODORICO

Rev8

ROBOTISED DISPENSING

SYSTEM

SOFTWARE MANUAL

Serial no. 38A1A - 38A1G

Rev. 0 (11/01/11)

Copy translated from the original italian text

PAGE INTENTIONALLY LEFT BLANK

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THEODORICO Rev8 - Ser. N° 38A1A - 38A1GSOFTWARE MANUAL - Rev. 0

INDEX

1 GENERAL .....................................................................................................................................................................5

1.1 MENU MAP ..................................................................................................................................................................................................... 5

2 MAIN ............................................................................................................................................................................6

2.1 MAIN - F1 ......................................................................................................................................................................................................... 62.1.1 PUSH BUTTON CONTROL PANEL .................................................................................................................................................... 62.1.2 MAIN CONTROL PANEL ....................................................................................................................................................................112.1.3 FILLING KIT DETAIL .............................................................................................................................................................................122.1.4 BULK DRAWING ...................................................................................................................................................................................142.1.5 FILLING DRAWING ..............................................................................................................................................................................172.1.6 MACHINE STATUS DISPLAY WINDOW: SYRINGE FRACTIONING ......................................................................................192.1.7 MACHINE STATUS DISPLAY WINDOW: VIALS FRACTIONING ............................................................................................202.1.8 RECIPES MANAGEMENT ...................................................................................................................................................................25

3 DECAY UTILITY .........................................................................................................................................................29

4 PRINT LAYOUT ..........................................................................................................................................................30

4.1 EDIT PRINT LAYOUT ..................................................................................................................................................................................304.2 SET PRINT LAYOUT ....................................................................................................................................................................................30

5 RECORD DATA ..........................................................................................................................................................31

5.1 RECORD DATA > LOGGER - F2 “PWD 1”..............................................................................................................................................315.2 RECORD DATA > FILLING REPORT - F3 “PWD 1” .............................................................................................................................325.3 RECORD DATA > DISCHARGE REPORT - F4 ......................................................................................................................................335.4 RECORD DATA > BULK LOG ....................................................................................................................................................................34

6 SETTINGS ..................................................................................................................................................................35

6.1 SETTINGS > SETTINGS - F5 “PWD 1” ...................................................................................................................................................356.2 SETTINGS > ADVANCE SETTINGS - CTRL + F5 ...............................................................................................................................386.3 SETTINGS > MANUAL “PWD 1” ..............................................................................................................................................................40

7 SYSTEM .....................................................................................................................................................................41

7.1 SYSTEM > LANGUAGE ..............................................................................................................................................................................417.1.1 SYSTEM > LANGUAGE > ENGLISH “PWD 0” ..............................................................................................................................417.1.2 SYSTEM> LANGUAGE > ITALIAN “PWD 0” .................................................................................................................................41

7.2 SYSTEM > USER ...........................................................................................................................................................................................417.2.1 SYSTEM > USER > LOGIN “PWD 0” ................................................................................................................................................417.2.2 SYSTEM > USER > LOGOUT “PWD 0”............................................................................................................................................437.2.3 SYSTEM > USER > NEW USER “PWD 2” ........................................................................................................................................43

7.3 SYSTEM > STOP “PWD 2” .........................................................................................................................................................................47

8 ALARMS ....................................................................................................................................................................48

8.1 LIST OF ALARMS .........................................................................................................................................................................................488.2 LIST OF MESSAGES ....................................................................................................................................................................................63

9 ATTACHMENTS .........................................................................................................................................................65

9.1 ATTACHMENT 1 - “REPORT DESIGNER” GUIDE ...............................................................................................................................659.1.1 INTRODUCTION ...................................................................................................................................................................................659.1.2 “REPORT DESIGNER” START ............................................................................................................................................................659.1.3 EXAMPLE OF CREATION OF A REPORT .......................................................................................................................................67

9.2 ATTACHMENT 2 - “CRYSTAL REPORT GUIDETM” ..............................................................................................................................759.2.1 INTRODUCTION ...................................................................................................................................................................................759.2.2 CREATION OF A REPORT USING CRYSTAL REPORTS ............................................................................................................75

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1 GENERAL

1.1 MENU MAP

The menus are structured as illustrated in the following layout:

Main

Decay Utility

Print Layout

Edit Print Layout

Set Layout Path

Record Data

Logger

Filling Report

Discharge Report

Bulk Log

Settings

Settings

Advance Settings

Manual

System

Language English

Italian

User LogIn

LogOut

New user

Stop

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2 MAIN

2.1 MAIN - F1

2.1.1 Push button control panel

The push button control panel described below is always present in the upper part of the screen of every synoptic:

Alarms and messages window

This window shows the messages and any alarms currently activated in the system.

• Alarm Description: The alarm description text string is fundamental for the identification of the alarm meaning (message). The “Alarms Description” button positioned on the bar on the upper window, allows to put the descriptions of the alarms present in the window into alphabetic order.

• Condition: The alarms window always indicates the effective status of the alarm regardless of the acknowledgement or reset condition. The alarm status indicates ON when the cause that generates it is still active (real status), while it indicates OFF when the alarm is present in the window but the cause that generated it has disappeared.

The acknowledgement of an alarm leads to the acoustic signal being silenced (if activated); this operation will be recorded in the “historic log” with the time of acknowledgement.

Acknowledgement takes place using the “Ack” button.

Alarm reset leads to the disappearance of the alarms window, as long as the cause that generated it is no longer active. If the cause of the alarm is still active, the Reset determines the re-start of the new alarm procedure, with consequent new silencing request.

Alarm reset is only effective if acknowledgment has been performed previously.

If Reset is performed correctly, it will be indicated in the Data Logger window with the indication of the alarm disappearance time, stating OFF. Alarm reset means the Reset signal is sent to the machine, used to annul the intervention memory if the cause that generated it has disappeared.

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Selected isotope window

The following window appears inside the push button control panel present in every synoptic, which informs the operator which isotope is being measured at the moment:

This section shows the detail of the isotope in use by the machine; they are represented in fields:

• isotope name;

• calibration factor set for the Bulk calibrator (K1);

• calibration factor set for the filling calibrator (K2);

• isotope decay time.

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Module functioning mode selector switch “PWD 1”

AUTOMATIC MODE

The automatic mode “AUT” envisions a RUN status, in which the module performs the production cycle set by the operator without interruptions.

The functioning status of the module in automatic mode (Run/Not Run) is displayed in the text bar under the Start-Park- Reset buttons:

MANUAL MODE

In manual mode, all module commands are given by the software user. The machine performs the commands received from the operator one at a time.

The main screen shows the manual controls relative to every cell element.

Control buttons

• START - “PWD 1”: on the START command, the module proceeds with the production of the lot set by the user (ON) as long as there are no alarms present in the system.

• STOP - “PWD 1”: on the STOP command the module shuts down (in whatever phase it may be). To start-up after interruption (whether due to a voluntary stop command or also an alarm in the module), press the Start key again after having acknowledged and reset the alarms present.

• RESET - “PWD 1”: this control is used to take the robot back to the initial condition. The reset operation is, for example necessary on machine start. A relevant message informs the operator of the necessity to command the reset. The run is removed at the end of the movement.

• PARK - “PWD 0”: this button puts the robot in a position called “Out Working Space”. It is a particular position in which the robot does not obstruct operator access inside the box. The run is removed at the end of the movement.

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Filling kit control buttons

The “Push button control panel” inside the synoptic also has a series of buttons that allow management of the filling kit:

BUTTON PASSWORD LEVEL ENABLING CONDITIONS

Apri Pinch (Open Pinch) 1 Automatic mode

Chiudi Pinch (Close Pinch) 1 Automatic mode

Da SINTESI (from SYNTHESIS) 1 Automatic mode

Diluisci Bulk (Dilute Bulk) 1 Automatic Mode and Run OFF

Bulk > Mother 1 Automatic Mode and Run OFF

Mother > Bulk 1 Automatic Mode and Run OFF

Edit Recipe 1

• Apri Pinch: commands the opening of all 6 pinch valves called 1,2,3,4,5,6; this command is used to replace the filling kit.

• Da sintesi: it is used to command the valves in liquid arrival from the synthesis module configuration; the window represented at the side opens through which the operator inserts a syringe that identifies the product that is being transferred and 2 fields for entering the date and time when synthesis of the radio medicine occurred, which is being transferred to Thedorico. It is starting from this value that the machine calculates the date and time of the expiry of the radio medicine by adding the “RADIO MEDICINE DURATION” set in the “Settings” window, described below.

INFORMATION

If the scales are present in correspondence with the bulk, a window will appear that asks the operator if he wants to tare

the weight of the scales;

• Chiudi Pinch: commands the closure of all 6 pinch valves; this command is used when the operator, on replacement of the filling kit, wants to close the valves to prevent liquids leaking inside the kit.

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• Diluisci Bulk: pressing this button recalls the following window:

Here the operator has the possibility of setting/calculating the amount of physiological solution with which he wants to dilute the bulk. The first tool allows to calculate the amount of physiological solution used for dilution by multiplying the current volume in the bulk by a dilution factor for the specific density of the NaCl.

The second tool calculates the amount of physiological solution to be added to the bulk in order to have the “requested concentration” at time “At”. Finally, it is possible to directly edit the desired amount (third tool).

Finally, a field is present in which it is possible to read/set the mixing time with any gas on conclusion of dilution with NaCl.

INFORMATION

This function only has meaning with the Theodorico A kit or with Kit A in bulk dilution configuration.

• Bulk ->Mother: pressing this button recalls the window:

Here the operator sets the amount of radioactive liquid to be transferred from the Bulk vial to the Mother vial. Pressing the “Start” button begins the transfer of the liquid.

INFORMATION

This function only has meaning with the B Theodorico kit.

• Mother->Bulk: pressing this button recalls the window:

Here the operator sets the amount of radioactive liquid to be transferred from the Mother vial to the Bilk vial. Pressing the “Start” button begins the transfer of the liquid.

INFORMATION

This function only has meaning with the B Theodorico kit.

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2.1.2 Main control panel

Vials fractioning with autoclave (complete system)

Syringe fractioning

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2.1.3 Filling kit detail

Graphical representation of the filling kit. It can assume different configurations depending on the kit effectively present on the machine;

Background is also present for the vial in filling mode: background activity measured [MBq] by the calibrator before starting to fill the vial in question.

The “Skip filling” button stops the filling operation in progress;

The “Reject” button labels the vial in filling mode as no good and it will be inserted in the rejects at the end of filling.

The lines are grey, red or blue depending on the liquid that circulates in them:

• GREY: no liquid

• RED: passage of radioactive liquid

• BLUE: passage of physiological solution

Possible configurations of the filling kit

• Kit A with Bulk dilution

• Kit A with final dilution

• Kit B

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• Kit W

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2.1.4 Bulk drawing

• ACT: Represents the value of activity present in the bulk vial; if the dose calibrator is present, the value is given by the same. If the dose calibrator is not present, the value of the activity is detected by the machine by multiplying the volume present by the concentration.

• VOL: Represents the volume of liquid present inside the Bulk vial. If the scales are present then the volume is calculated starting from the weight detected by the scales multiplied by the density. In order to have a reliable value, the operator must carry out the scales offset measurements correctly.

• CON: Represents the specific activity value of the liquid contained in the bulk. This value is detected starting from a start value with the decay formula of the radioisotopes. The start value is calculated by the machine as Act/Vol at the time when there is transfer from synthesis or during dilution of the bulk or it cab be set by the operator via the “SetConcentration” window, which is accessed by pressing the menu represented above.

By double clicking on “BULK” it is possible to display a menu for setting several parameters.

Scale Detail

Press the “Scale Detail” key to access the synoptic:

The status of the scales placed in correspondence of the Bulk vial is shown here. The weight, the offset value (value measured when the zero button is pressed) are shown, a value of the density of the liquid contained in the bulk is set through which the program reaches the volume. The stable/positive/scales error status are also signalled.

The “Zero” button (active only in manual mode in the scales destination) zeroes the weight, the “Config Mode” button puts the scales in configuration mode. In this mode the weight is not read by the machine but must be connected to the scales via serial cable and“innovation” software (installed on the machine PC) to configure/calibrate the instrument.

For information regarding the use of the Innovation sw, refer to the manual concerning the same.

On closure of the synoptic, the eventual “Config mode” status is automatically reset.

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Finally, a “Scale Data Logger” button is present, by pressing which access is given to the synoptic that shows the log of the data measured by the scales.

Set concentration

In this window, the operator sets the known concentration value at the time and by pressing the “CONFIRM” key forces this value as concentration in the Bulk.

Using the “Paste” button it is possible to copy the concentration value of one of the previously-filled vials and paste this value here.

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Log

By pressing on Log, access the log of the operations performed on the Bulk:

This window shows the log of all operations performed on the Bulk; it is possible to filter the Trace ID of the radio medicine (field set by the operator immediately after the “Da Sintesi” key is pressed).

The date and time , activity value, volume and concentration, enabled operator name and description of the operation performed are stated for every operation; the description of the operation will be: Start from Synthesis, Arrival from synthesis end, start dilution, end dilution, from Bulk to Mother, From Mother to Bulk.

Using a key called “Display Report” it is possible to display and print the detail of the operations so as to attach them to the documentation produced.

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2.1.5 Filling drawing

• ACT: Represents the activity value present in the filling vial; the value is given by the dose calibrator.

• VOL: Represents the volume of liquid present inside the vial. If the scales are present then the volume is calculated starting from the weight detected by the scales multiplied by the density. The machine automatically measures the offset at the relevant time. If the scales are not present the volume is calculated by multiplying the number of revs that the peristaltic pump makes for a constant (nç cc/pump rev) set by the operator.

• CON: Represents the specific activity value of the liquid contained in the vial. This value is detected starting from a start value with the decay formula of the radioisotopes. The start value is calculated by the machine as Act/Vol.

• BKD: Represents the background value of the calibrator, calculated automatically by the machine.

By double clicking on the “FILLING” label, a menu is displayed as shown in the previous image.

Call Robot

By selecting this item, in manual mode, the robot positions itself on the station.

Scale Detail

Press the “Scale Detail” text to access the synoptic:

The status of the scales placed in correspondence with the filling station is shown here. The weight is displayed and the stable/positive/scales error status are signalled.

The “Zero” button (active only in with machine in manual functioning mode) zeroes the weight, the “Config Mode” button puts the scales in configuration mode. In this mode the weight is not read by the machine but must be connected to the scales via serial cable and“innovation” software (installed on the machine PC) to configure/calibrate the instrument.

For information regarding the use of the Innovation software, refer to the manual concerning the same.

On closure of the synoptic, the eventual “Config mode” status is automatically reset.

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By pressing the “SCALE DATA LOGGER” button access the synoptic that displays the log of the data measured by the scales.

View detail

Click on “View detail” to access the synoptic that shows all features of the vial, which is in the filling station, in detail.

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2.1.6 Machine status display window: syringe fractioning

Reference Description

1 Representation of Bar-Code reading station

2 Representation of the filling station

3 Representation of vials/syringes inlet area

4 Representation of discharge area in shielded container

5 Representation of the filled syringe accumulation area

6 Representation of mother vial

7 Bulk representation

7

6

5

4

15

2

3

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2.1.7 Machine status display window: vials fractioning

2

1

3

Reference Autoclave Description

1

WITH AUTOCLAVE Representation of Cap, Lock-nut and Crimping removal/insertion stations

WITHOUT AUTOCLAVE Representation of Cap, Lock-nut and Crimping removal/insertion stations

2

WITH AUTOCLAVE Representation of the filled vials storage area

WITHOUT AUTOCLAVE NOT PRESENT

3

WITH AUTOCLAVE Representation of the rejected vials storage area

WITHOUT AUTOCLAVE Representation of the filled vials accumulation area

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Representation of the filling station

• “SKIP” / “SKIP FILLING”: positioned in proximity of the filling area. Pressing this button interrupts any filling in progress. The peristaltic pump stops and the vial being filled is withdrawn by the robot in order to continue the cycle.

If it is pressed during a Bulk – Mother, Mother-Bulk, Bulk Dilution transfer, only the peristaltic pump stops.

The button is useful for example if the operator realises that liquid has finished in the Bulk during fractioning.

• “REJECT”: positioned in proximity of the filling area. Pressing this button, the operator asks the machine to place the vial or the syringe in filling mode in the rejects area. The machine ends the filling in progress and then the robot will withdraw the vial/syringe just filled and place it in the rejects area.

Representation of vials/syringes inlet area

The image from above of the airlock upper door (pre-chamber in class B for entry into the main box of the consumable material: vial, kit, syringe..)

Two buttons are present called “UP” and “DOWN”:

• “AIRLOCK UP”: pressing this button memorises the inlet request into the tray containing the consumables from the main box (normally vials or syringes).

The effective entry takes place when by placing the machine in automatic mode and in run time, the process controller automatically

Inflates the lower gasket

Waits for a time T set in the “Standard Settings” under “Airlock Class Time”,

Deflates the upper door gasket

Asks the robot to open the upper door

Waits for the upper door to be opened

Moves the tray containing the consumables up into the main box.

• “AIRLOCK DOWN”: pressing this button memorises the outlet request of the tray containing the consumables from the main box (normally vials or syringes).

The effective exit takes place when by placing the machine in automatic mode and in run time, the process controller automatically

Moves the tray containing the consumables down from the main box.

Requests the robot to close the upper door

Waits for the upper door to be closed

Inflates the upper gasket

Deflates the lower door gasket for operator access to the pre-chamber

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Representation of Vials/syringes Rack


1 Vial/syringe present

2 Vial/syringe NOT present

If the representation of the presence of vials (syringes) does not correspond with reality, the operator (PWD 2) can, on condition that the machine is not running, select the “position” that does not correspond to the real state and, by pressing the space bar, communicate the real presence state (absence) of the vial.

This function is INDISPENSABLE in managing the infeed rack (18 positions); when the infeed rack is taken inside the box, the system assumes that of the positions are empty. If this is not the case because the operator has loaded the rack, the machine must be informed.

ATTENTION

When format is changed or when a new rack is inserted via the air-lock drawer, the system assumes that all rack

positions are empty.

If this is not the case, the operator must indicated which are the positions occupied by the vials/syringes (see above).

Great attention must be paid during this procedure, because if empty positions are incorrectly signalled as occupied,

during the automatic filling cycle, the robot could collide against vials/syringes with consequent damage.

By positioning the cursor inside a rack, but double clicking, the menu appears

Click on “View” to access the synoptic that shows all features of the vial (syringe), which is in the selected position, in detail.

1

2

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For every vial (syringe) inside the cell, the system memorises and here shows the operator:

• Batch

• Code1

• Code2

• Bar Code

• Activity requested at the time of injection

• Date and time at dose filling start

• Volume inserted: total volume , volume of activity, volume of physiological

• Activity measured by the dose calibrator at the time of the measurement

• Concentration estimated as Activity measured/Total volume at the time of measurement

Notice the presence of the Copy button; this allows to copy the value of the concentration shown in order to take it to the concentration of the Bulk.

• Activity calculated at the time of injection

• Presence/absence of cap status

• Presence/absence of the lock-nut status

• Bar-code read/not read status

• Filling performed status

• Calibration performed status (measurement inside the dose calibrator)

• Crimping performed status

• Sterilisation performed status

• Vial inspection performed status

• “Vial to be rejected” status assigned for some reason by the operator

“Call Robot” is only activated in the manual functioning mode and pressing it calls the robot in correspondence of the position in question.

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Representation of the vials/syringe discharge area

The removed cap situation is represented on the left, on the right the cap inserted situation. Note “Cap Out” and “Cap In” positioning in the correspondence of which, in manual functioning mode, it is possible to recall the robot.

Representation of Cap, Lock-nut and Crimping removal/insertion stations.


1 Last bar-code read MANUALLY

2 Last bar-code read AUTOMATICALLY

Note “Crimping”, “Lock-nut”, “Cap”, “Bar Code” positioning in correspondence of which, in manual functioning mode, it is possible to recall the robot.

A red circle inside the stations represents the internal presence of the vials, the lock-nut and the cap. The 2 circumferences above visible in every station are alternatively coloured in grey and green:

• Inner green circumference -> pliers closed

• Outer green circumference -> pliers open

1

2

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2.1.8 Recipes Management

By pressing the “Edit Recipe” button on the main synoptic, access the window that shows the production lot currently being worked:

In the upper part of the screen, the lot summary is shown in yellow via the following fields:

• Total number of vials (or syringes) that make up the lot

• Total activity value (expressed in ml and in MBq) requested for the lot

The following diagram shows the representation of the production lot currently being worked;

Carry out this recipe:

This button allows to start the recipe.

Lot menu

The menu bar is present in the upper part of the window. The “Lot menu allows to modify the settings of the lot being worked.

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Edit - “PWD 1”

Once the operator has selected the name of the lot to be worked, he cab add (“ADD” button), modify (“MODIFY” button) or remove (“ELIMINATE” button) the records that are part of the same lot.

Every record is defined by the fields.

• Code1,

• Code2,

• Activity Request: expressed in ml or in MBq; by clicking in correspondence with this field, the “Insert Request Activity” synoptic opens: the activity value requested must be inserted here; to change from activity to volumetric, the operator will click in correspondence with the “Request a volume” field.

If filling takes place outside the calibrator, in a loading cell, if the request is expressed in MBq then the program will convert the Mbq into ml on filling, according to the formula.

Volume request= Activity Request/Bulk Concentration

(reported at the same moment in time)

In this case, the precision of the value of concentration in the bulk is very important.

• Injection time: it has meaning if the value of radioactivity requested in the point above is expressed in MBq It is the time when you want to have that value.

By clicking in correspondence with this field, the “Calendar” synoptic opens, where the time in which the requested activity is desired is introduced.

• Priority: indicates the priority level of the current record. If the bar-code option is not activated, then the records with less priority are those that have precedence in filling, e.g. on three records with priority 1,2,3 that requested first by the system is that with priority 1.

If, instead, the “bar code” and “connect filling with bar code” options are enabled, then this field assumes a different meaning: a label must be applied to every vial to be filled (Print -> Current Record) containing all of the information of the record being worked and in particular, also code128 of the “priority” field. The robot will take the vial from the inlet airlock, will read the bar-code and will read in the list of records being worked, data of that with the same priority as the value just read. In this case, the decision of the order with which the records are worked is the physical position of the vials inside the airlock.

ATTENTION

The vial filled first is not that which will be discharged first if there is the autoclave or if the discharge station is not

available when the dose has been filled.

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• Reject after filling: if enabled, the vial in question will be filled and then placed inside the reject vials accumulation area.

• Bubble point test after filling: if enabled, the vial in question will be filled and then placed on the filling needle to allow the operator to test the filter.

Save As

Copy the entire lot being worked into a new lot defined by the user:

Follow the window

Pressing Yes, the program modifies the fields of the original “Injection Date” recipe, putting the date as of today, pressing no, the lot is copied entirely as it is.

Delete Current Lot

Eliminates the lot being worked (after confirmation request)

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Menu Print

If the operator must print the labels with the information of the records belonging to the lot being worked, he will use the menu present in the upper part of the synoptic.

Current Lot

Prints all labels of the lot currently selected with the format chosen in the previous point.

Current Record (ON THE “RECEIPE EDITOR” WINDOW MENU)

Print a label with the data of the record currently selected and with the format selected in the previous point.

Edit Customer

In this window the operator will insert the name and address of the production centre of the radio medicine and will define any customers to which the centre usually sends the radioactive product.

To do this he will edit the name and address of the customer and then memorise the data introduced by pressing the “introduce - update” button. If a customer introduced previously is to be eliminated, select the same using the drop down menu in correspondence the “Customer Name” and delete it from the list by pressing the “Eliminate” button.

The information inserted in this synoptic will be used by the machine to print the labels and to edit the recipes where, in “field 1”, the machine will propose all customers memorised here via a drop down menu.

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3 DECAY UTILITY

This utility is useful to calculate the volume or activity requested depending on the decay time of the isotope being worked.

• Activity Calculator: given the timed activity value T0, the tool calculates the activity value at time T1.

• Volume Calculator: given the concentration value at time T0 and a desired activity at T1, the tool calculates the corresponding volume.

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4 PRINT LAYOUT

4.1 EDIT PRINT LAYOUT

The Theodorico Report can be managed via Report Designer1;

The Reports are the instruments used to display or print archived data from the process in a determined period of time. Thanks to the ReportDesigner, management of the Reports becomes extremely easy to obtain, guaranteeing the necessary opening in order to obtain prints of Reports exactly suitable for the individual needs of the final customer.

It is for this reason that Theodorico integrates the “Report Designer” in order to give users the possibility to autonomously create reports relative to the databases of the same.

Moreover, Theodorico also maintains the compatibility with the “report engine” of “Crystal Report™”, but in this case, the instrument is not integrated and must be purchased separately in order to create the desired reports.

The report files can have different extensions.

• files crated with “Report Designer” have the “.repx extension

• files created with “Crystal Report™” have the “rpt”. extension

A report file can be associated to a resource “DataLogger/Recipe”, to an object “Historical Log Window” and an object “DB Trace Window”. When a report file is introduced into the “Report File” of one of these objects, the “Print” command available in the “Logger-Recipes Data Window”, “Historical Log Window” and “DB Trace Window” objects, the report will be printed. If the report file has the“.repx” extension, Theodorico will perform the operation using the “Report Designer” libraries. If the file has “.rpt” extension, Theodorico will use the “Crystal Report™” libraries.

4.2 SET PRINT LAYOUT

The format with which the labels are printed can change depending on the desired language or customer needs. For this purpose, a series of layouts are available in the PC, which are described in *.repx file format, which the operator can select through this menu.

1 For further information regarding the use of Report Designer and Crystal Report, see the final attachments

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5 RECORD DATA

5.1 RECORD DATA > LOGGER - F2 “PWD 1”

The Historical Log or Historical Archive of the events chronologically records all of the significant events that have taken place on the machine managed by the project. Significant events mean:

• The system operations (manoeuvre of the operator on the system).

• The system diagnostics (autodiagnostics, diagnostics of the drivers).

• All project alarms and messages.

The bottom side has buttons to update the screen, filter the events and print the events log.

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5.2 RECORD DATA > FILLING REPORT - F3 “PWD 1”

Production activity control.

All THEODORICO production activity is maintained in two “data loggers” on the management PC, all production lot data are memorised at the end of every cycle as envisioned by the cGMP and GAMP Standards. The “data loggers” record the following information:

• Log 1 (F3): the recording is made on completion of the filling cycle< the data inserted concern:

• User/operator logged into the system;

• Identification of the dose produced via lot, code 1 and code 2;

• Identification of the vial/syringe, containing the dose stated in the point above, using the pre-labelled bar-code;

• Value of radioactivity requested by the operator (activity + volume) inside the vial/syringe at a certain time (injection time);

• Time distance in minutes between the time of filling and the time of administration of the dose;

• Activity that the vial/syringe must contain on preparation, calculated by the system in relation to the time of administration;

• Date and time of filling start;

• Date and time of filling end;

• Duration of the filling cycle;

• Activity effectively inserted into the vial/syringe;

• Total volume (isotope + physiological solution inserted into the vial/syringe);

• Name of the isotope dispensed inside the vial/syringe;

• Percentage error referring to the activity value inserted;

• Log 2 (F4): the recording takes place at the end of the discharge cycle (delivery to the operator of the shielded container enclosing the dose, the data introduced regard:

• User/operator logged into the system;

• Exit time of the vial/syringe from the machine;

• Identification of the vial/syringe delivered via lot fields, code 1 and code 2;




• Date and time of filling end;

• Expiry date and time of the vial/syringe delivered (filling date and time + time set by the operator.

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5.3 RECORD DATA > DISCHARGE REPORT - F4

The synoptic that is displayed shows a data logger containing the data of all doses produced and discharged:

The fields shown are:

• Date and time of discharge of the dose produced;

• Identification of the operator that has used the machine;

• Identification of the vial/syringe produced via lot fields, code 1 (name of the customer if defined in the “customer Editor” window, customer address if defined in the “customer editor” window) and code 2;




• Name and address of the production centre of the radio medicine as recorded in the “customer Editor” window;

• Name of the fractioned isotope;

• Expiry date and time of the vial/syringe delivered (synthesis date and time + time set by the operator in the Standard Settings page).

A button called “View delivery Note” is present, which opens

The preview window of the sheets to be attached to every transport container. If the Theodorico PC is connected to an A4 printer (not supplied by the machine), it is possible to print all sheets.

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5.4 RECORD DATA > BULK LOG

By pressing on Log, access the log of the operations performed on the Bulk:

This window shows the log of all operations performed on the Bulk; it is possible to filter the Trace ID of the radio medicine (field set by the operator immediately after the “Da Sintesi” key is pressed).

The date and time , activity value, volume and concentration, enabled operator name and description of the operation performed are stated for every operation; the description of the operation will be: Start from Synthesis, Arrival from synthesis end, start dilution, end dilution, from Bulk to Mother, from Mother to Bulk.

Using a key called “Display Report” it is possible to display and print the detail of the operations so as to attach them to the documentation produced.

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6 SETTINGS

6.1 SETTINGS > SETTINGS - F5 “PWD 1”

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Filling station settings

• FDG Line: ml inserted per pump rev PWD 1

Indicates the volume of liquid that the peristaltic pump transfers every rev via the active channel. This value is used by the machine to determine the volumes of liquid moved between the different containers making up the system:

Bulk <-> Mother; Bulk ->Filling

The parameter looses meaning if the scales are present in correspondence with the Bulk station (for the calculation of the liquid transfer from Bulk to the Mother) as the scales are considered.

The parameter looses meaning if the scales are present in correspondence with the filling station (for the calculation of the liquid transfer from Bulk to Filling) as the scales are considered.

• Physiological line: ml inserted per pump rev PWD 1

Indicates the volume of liquid that the peristaltic pump transfers every rev via the non-active channel. This value is used by the machine to determine the volumes of liquid moved between the different containers making up the system:

Physiological -> Bulk; Physiological ->Filling

The parameter looses meaning if the scales are present in correspondence with the Bulk station (for the calculation of the liquid transfer from the physiological solution to the Bulk) as the scales are considered.

The parameter looses meaning if the scales are present in correspondence with the filling station (for the calculation of the liquid transfer from the physiological solution to Filling) as the scales are considered.

• Nominal pump speed PWD 1

Indicates the maximum speed (expressed as a percentage) at which the system can turn the peristaltic pump;

• Pump low speed PWD 1

Indicates the speed (expressed as a percentage) used by the filling station when approaching the final value to be filled;

• Vial capacity PWD 1

Indicates the maximum volume that the vial, with which the system works, can contain. The machine never dispenses a value greater than that set. If this prevents the requested activity value being reached, the relevant alarm signal will appear.

• Syringe capacity PWD 1

Indicates the maximum volume that the syringe, with which the system works, can contain. The machine never dispenses a value greater than that set. If this prevents the requested activity value being reached, the relevant alarm signal will appear.

• Bulk Capacity PWD 1

Indicates the maximum volume that can be contained in the BULK vial, with which the system works. During dilution of the BULK, the machine never introduces a greater volume than that set here.

• Activity line: pipe volume PWD 1

Indicates the volume of the filling kit activity line. This value is used for the air bleeding phase (air compensation).

• Margin of error PWD 1

Indicates the percentage error that the operator accepts when preparing the doses. If at the end of filling that inserted into the machine does not lie within the margin or error set, an alarm message will be generated.

• Radio medicine duration PWD 1

Indicates the time expressed in hours, over which the dose prepared can no longer be considered usable. On every label printed by the machine there is the presumed expiry of the dose. The expiry is calculated from the time of execution of synthesis of the radio medicine (see Da Sintesi button on the push button control panel).

• Bulk mixing time PWD 1 (if active)

Represents the mixing time of the BULK via the introduction of gas via the relevant solenoid valve – this mixing is performed automatically after the dilution phase.

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• Volumetric functioning PWD 2

By enabling this box, the machine performs filling using volume and not activity. It must be noted how in volumetric functioning mode a request for 1 MBq in the request activity field corresponds to a dose of 1 ml.

• Label PWD 1

It is possible to disable the automatic printing of the labels in correspondence with the discharge of every vial/syringe or set 2 different types associated to 2 different printers. Normally a printer for Type 1 labels is supplied with the Theodorico (see print management paragraph).

• Cycles continuously

The user of the Theodorico could need to fraction doses all the same into high quantity. By enabling this field, the system cyclically performs the recipe set. Typically the recipe will contain just one record that will be worked in every vial (syringe) present in the infeed rack.

Setting the robot station

• Robot maximum speed PWD 2

Using this editing box, select the maximum speed at which the robot must function .

• Control of Robot torque PWD 2

Using this editing box, select the maximum torque that the robot can undergo following a blow, before removing power to the motors;

Pay attention not to lower the value excessively as a power drop at the motors could occur not following a blow but following rapid acceleration.

• Maximum number of vials in rack PWD 1

This parameter has meaning if working with vials and autoclaves. It represents the maximum number of vials that can be loaded onto the rack present in the accumulation area of filled vials. The value can vary from 1 to 9.

• Exclude syringe lung

Use this box to inform the machine whether to consider the “storage” station of the filled syringes if the drawing system is not available. By enabling this box, the robot will withdraw the syringe from the filling station only if the drawing system is available.

• Autoclave enable

Use this box to inform the machine that the autoclave is present. Each filled vial will be autoclaved before being discharged.

• Barcode enable

This box is used to exclude/include bar-code management in the machine cycle.

• Connect Filling With BarCode

The syringes/vials are placed in correspondence with the label. The label layout and the print button appear in the EDIT RECIPE synoptic. In this case, the corresponding vial is associated at the time the bar-code is read. This type of label contains a larger number of fields: isotope, expiry (only vial), lot, cod1 and cod 2 (only vial), identification, activity requested and corresponding time, bar-code.

Box settings

• Fan Speed

THEODORICO has an independent ventilation system that allows to keep the envisioned classification inside the various areas, with the envisioned pressure jumps. A unique external fan maintains the dispensation area in negative pressure and also guaranteed the necessary fresh air (more that 60 rec/h) inside the airlock and the drawing system. This box can be used by the user with password level higher or equal to 2 to change the fan speed.

• Airlock class time

Time duration that must pass between closure of the airlock door and opening of the upper shielded door (opened by robot).

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• Drawing system class time

Time duration that must pass between closure of the drawing system door and the removal of the cap by the robot.

• VHP

Allows to set-up the cell for connection to the VHP system.

6.2 SETTINGS > ADVANCE SETTINGS - CTRL + F5

Several construction parameters of the machine, which cannot be modified, are shown in the upper part of the Advance Settings window.

• If filling takes place inside the shielded calibrator or outside of it (FillingOutOfCalibrator)

• If the autoclave is mounted (Autoclave)

• If the robot must move the racks or not (Rack Moving)

In the Kit Type section it is possible to select the type of kit desired: Type 1, 2, 3. If kit Type 1 is selected, it is possible to set the type of dilution (in the Bulk or in final filling).

If dilution takes place in the bulk or in each individual vial filled, vial inspection can be enabled/disabled (if enabled, every vial will be displayed to the operator by the robot before discharge so that the operator can decide whether to reject it immediately or place it in the rejected vials station).

It is possible to set a “target concentration” with which the operator intends to work (Bulk concentration).

It is possible to excluded the descent of the vial in filling mode inside the calibrator (only in volumetric functioning mode – Calibrator Moving).

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• Bulk Concentration Calc PSW 2

This function allows to decide how to calculate the Bulk concentration.

1) Activity/Volume: in this way, the concentration is calculated by dividing the activity measured by the calibrator and the volume measured by the scales.

2) Decay: in this way, the concentration is calculated of the decay relative to the isotope used starting from the activity and initial volume of the Bulk.

• Lock-nut Fibre Excluded PSW 2

There is an optical fibre in proximity of the pliers that remove and insert the lock-nut onto the vial, which detects the presence of the lock-nut itself. If this fibre does not function correctly, the machine goes into alarm conditions. In this case, for the time necessary to adjust or replace the fibre, the operator can exclude reading of the same by the controller.

ATTENTION

With the fibre excluded, the system is not aware of any mechanical problems that may appear in the lock-nut removal/insertion phase, as for example, the non-removal of the same by the pliers.

• Cap Fibre Excluded PSW 2

There is an optical fibre in proximity of the pliers that remove and insert the cap onto the vial, which detects the presence of the cap itself. If this fibre does not function correctly, the machine goes into alarm conditions. In this case, for the time necessary to adjust or replace the fibre, the operator can exclude reading of the same by the controller.

ATTENTION

With the fibre excluded, the system is not aware of any mechanical problems that may appear in the cap removal/insertion phase, as for example, the non-removal of the same by the pliers.

• Robot Fibre Excluded

There is an optic fibre in proximity of the robot pliers, which detects the presence of the different objects handled by the robot (vials, syringes, DS cap, access door to the vials infeed pre-chamber, rack). If this function does not function correctly, the machine does not function correctly.

In this case, for the time necessary to intervene on the fibre to adjust or replace it, the operator can exclude reading of the same by the controller.

ATTENTION

With the fibre excluded, the system is not aware of any mechanical problems that can appear in the withdrawal/delivery phase of the objects, by the robot.

• Cap Fibre drawing system excluded

There is an optical fibre in proximity of the upper cap of the drawing system, which detects its position. If this fibre does not function correctly, the machine does not function correctly.

In this case, for the time necessary to intervene on the fibre to adjust or replace it, the operator can exclude reading of the same by the controller.

ATTENTION

With the fibre excluded, the system is not aware of any mechanical problems that can appear in the withdrawal/delivery phase of the objects, by the robot.

• Excludes Software interlocks

Function only allowed by COMECER technicians.

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6.3 SETTINGS > MANUAL “PWD 1”

1) Commands of the pliers that remove and insert the shielded container cap: lift, open, lower, close

2) Commands the slide that moves the shielded container: towards operator, in intermediate position, towards robot, up and down slide

3) Commands of the gasket positioned in proximity of the operator access door:

On -> inflate gasket

Off->deflate gasket

4) Commands of the gasket positioned inside the box in proximity of the tray entry area


Off->deflate gasket

5) Commands of the cylinder that lifts and lowers the syringe/vial holder tray

6) Commands of the gasket positioned in proximity of the operator access door


Off->deflate gasket

The buttons are always visible but are only active in manual mode; they can be green or red:

• Red: the actuator is found in the condition described by the button (e.g. in the figure above, all three gaskets are deflated as the off buttons are red)

• Green: the actuator is NOT in the condition described by the button

1

2

3

4

5

6

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7 SYSTEM

7.1 SYSTEM > LANGUAGE

7.1.1 System > Language > English “PWD 0”

By using the mouse to click on “English”, the English language is activated for use.

7.1.2 System> Language > Italian “PWD 0”

By using the mouse to click on “Italiano”, the Italian language is activated for use.

7.2 SYSTEM > USER

7.2.1 System > User > LogIn “PWD 0”

Users and Passwords management

The use of Users and Passwords in a project allows to manage access to the functionality realised in complete safety.

In a supervision project it is often necessary to manage running of the system in safety, guaranteeing access to system functions only after the user has been authenticated. Safe running and management of the system takes place in Theodorico via the use of the Users and Password management.

The Users and Password management in a supervision project allows to manage the safe access of the supervisor, declaring a “list” of users enabled to run the system, giving them an exclusive password and eventually an access level. The access privileges (Hierarchy level and Area) can be instituted by name of by group.

In managing users of Theodorico, every user is assigned a User Password Level that allows to authenticate the user and an Access Level that defines the reading and writing rights that user an perform on the different project controls.

Password User Levels

The Password User Levels are used to be able to authenticate the user. When a user performs Login, the Password level is activated and therefore the user will be enabled to perform all commands protected by the same password or at a lower level than that of the user. The following User Password Levels are available:

• User Level 0 (0)= no operation allowed except machine stop and page change

• User Level 1= password levels requested to operate on the machine daily; some parameters, which request a higher level, cannot be modified. These password levels are assigned to the simple users of the project.

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• User Level 1-1023= password level requested to access and modify machine parameters deemed most significant as they can alter the performance and behaviour of the machine.

• Developer User Level 1024= password level for developer users. With this password level it is also possible to perform project development.

ATTENTION

The management of the Password User Levels is hierarchal, i.e. every User of a determined level can also carry out

operations at lower levels. The lowest user level is level 1, while the highest user level is the developer level.

Access Levels (Areas)

When the first user authentication phase has been passed, i.e. after login has been performed correctly, it is possible to limit the possibilities of user intervention on the different controls or components of the project, using “Access Levels”.

There are 16 distinct access levels, from “Access Level 1” to “Access Level 16”. In this case, each Access Level, which can be activated via Check-Box, is independent from the others, e.g. by enabling only “Access Level 5” on a button control, only the users that have “Access Level 5” marked in their mask can access that button. The Access Mask set on different users must therefore correspond with the Access Mask set on the controls or components of the project in order to give the access rights in reading/writing to those components.

The Access Levels are not managed in an hierarchal manner, therefore the highest level by numbering (e.g. Level 16) do not acquire the access rights of the lower level (e.g. Level 1).

The figure illustrates an example of access control of the LogOn users.

See how, on the basis of the level and the area of access requested to perform the commands, users 1 and 2 with their privileges, are admitted or not on execution of the command.

ATTENTION

The machine DOES NOT manage the Access Levels; it therefore refers only to password levels

Login opens a window to perform access to the program and use the privileges envisioned for the user that has accessed.

The default user set is:

• User: COMECER

• Password: COMECER

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7.2.2 System > User > LogOut “PWD 0”

Logout allows the user currently connected to disconnect.

7.2.3 System > User > New user “PWD 2”

New User opens a window that allows the management of the pre-existing users and the creation of new ones.

Obviously, certain system credentials are necessary (e.g.: system administrator) to access this window and perform the add new users operation.

• New Group: This button allows to create a new Users Group. Default parameters will be inserted into the group, which can then be modified.

• New User: This button allows to create a new User within the Group currently selected. Default parameters will be inserted into the user, which can then be modified.

• Eliminate: This button allows to eliminate the User or Group selected.

• Load File: This button allows to load a user file already present. The files searched for are those with the “.rtusers” extension.

• Save with name: This button allows to save the current project on file, specifying a file name. The“ .rtusers” extension, if not specified, will be inserted automatically.

• OK: This button exits the application, saving the project automatically. If the project was not already previously saved the save window will be shown.

• Annul: This button exits the application without saving the project, therefore any modifications will be lost.

• ?: This button opens the application help file.

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Users Group

The following settings mask will be offered on insertion of a new Group or every time a Group is selected:

• Name: The name of the group to be created can be introduced into this editing box.

• Description (Electronic Signature CFR21): A description of the group to be created can be introduced into this editing box. The description is only a reminder for the programmer and will only open in the Group “Properties Window”.

• Default Level: This property allows to define the Password Level to be associated to the group. This property is propagated automatically also to all users that are created inside the group, unless modified via the user properties.

• Default Access Level: This property allows to define the Access Level mask to be associated to the group. This property is propagated automatically also to all users that are created inside the group, unless modified via the user properties (not managed by the software).

• Password Duration (Days): This property allows to define the number of data after which the User Passwords associated to the Group expire and can no longer be used. Once expired, on successive authentication of the User, the introduction of a new password will be requested. The value of this property is only considered if the same property associated to the individual User is left at zero. If the value of both properties is left at Zero, the password will not expire.

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• Enable Auto Log off: In Run time mode, a password request always leads to the activation of a user Via the “Enable Auto Log off” property, if activated, the Log off will be performed automatically from Movicon after the time set in the “Logoff Automatically after (sec)” property. The time count will start from when the user does not perform any operation on the keyboard or using the mouse. By enabling this property on the Group it will be consequently enabled for all Group users.

INFORMATION

If the “Enable Auto Log off” property is disables, a user that performs Log on will remain active until a deactivation

command is carried out (established by the programmer in the project) or the user is not replaced by a different user.

The “Enable Auto Log off” property for the user and the group and this setting is managed in “OR”, therefore it is sufficient that one of the two properties is enabled.

• Auto Log off after (sec): Using this property it is possible to set the time after which Movicon will perform Auto Log off of any active user. Naturally this setting only has meaning if the “Enable Auto Logoff” has been activated. The time count will start from when the user does not perform any operation on the keyboard or using the mouse. The value of this property is only considered if the “Enable Auto Log off” property associated to the individual User is disabled.

Users

The following settings mask will be offered on insertion of a new user or every time a user is selected:

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• Name: Editing box in which the user name must be assigned (User ID). The field allows the introduction of alphanumerical characters and is “Case Sensitive”, i.e. it discriminates capital letters from small letters.

The declaration of the name must be unmistakable and is mandatory.

• Description (Electronic Signature CFR21): Editing box in which a descriptive text of the user profile can be associated to the name of the same.

The description of the user will be used by the system to identify the active user and therefore register him where envisioned, according to the provisions requested by the “Electronic Signature”.

The description is unmistakable and is mandatory.

• Password:

This property allows to introduce the Password relative to the User. The field allows the introduction of alphanumerical characters and is “Case Sensitive”, i.e. it discriminates capital letters from small letters.

The declaration of the password is mandatory.

• Numerical Password: This property allows to introduce a numerical password that can be used instead of the alphanumerical type.

• User Level: This property allows to define the Password Level to be associated to the user. By default the setting of this field is selected on “Acquire Group Level (-1)”, i.e. meaning that the user automatically acquires the Level of the group to which it belongs. It is however possible to select a customised level for the user, independently of the group it belongs to.

Movicon envisions up to 1024 password levels, where the first 1022 levels are the lower type (for the users), level 1023 or “Administrators” also authorises the commands on the operational system and level 1024 or “Developer”, the maximum, authorises access to the project being programmed.

The declaration of the level is mandatory.

• Access Level: This property allows to define the Access Level mask to be associated to the user. On creation of the user this property will be set automatically at the “1-16” value (not managed by the software).

• Password Duration (Days): This property allows to define the number of days after which the User Passwords expire and can no longer be used. Once expired, on successive authentication of the User, the introduction of a new password will be requested. If the value of this property is left at zero, the value of the same property associated to the group to which it belongs will be considered. If the value of both properties is left at Zero, the password will not expire.

• Enable Auto Log off: In Runtime mode, a password request always leads to the activation of a user Via the “Enable Auto Log off” property, if activated, the Log off will be performed automatically from Movicon after the time set in the “Logoff Automatically after (sec)” property. The time count will start from when the user does not perform any operation on the keyboard or using the mouse.

INFORMATION

If the “Enable Auto Log off” property is disables, a user that performs Login will remain active until a deactivation

command is carried out (established by the programmer in the project) or the user is not replaced by a different user.

The “Enable Auto Log off” property for the user and the group and this setting is managed in “OR”, therefore it is sufficient that one of the two properties is enabled.

• Auto Log off after (sec): Using this property it is possible to set the time after which Movicon will perform Auto Log off of any active user. Naturally this setting only has meaning if the “Enable Auto Logoff” has been activated. The time count will start from when the user does not perform any operation on the keyboard or using the mouse.

• Disabled: This property allows to disable the user. In this way, the user will not be managed in run time phase.

• Blocked: This property allows to block the user. A “blocked” user cannot be replaced with a run time user that has the same name. In this way, any run time user with the same name will not be managed.

• Mandatory Password Modification: If enabled this property allows to act in a way that at the first login of the user just created, the user can modify his password. In this way, the user can set his own password different to that introduced by the programmer.

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• Mobile Telephony International Code

It is possible to introduce the international code relative to the user mobile phone number in this editing box.

• Mobile Telephony Code

It is possible to introduce the national code relative to the user mobile phone number in this editing box.

• Mobile Telephony Number

It is possible to introduce the number for user mobile telephone in this editing box.

• Voice Messages International Code

It is possible to introduce the international code relative to the user voice message number in this editing box.

• Voice Messages Code

It is possible to introduce the national code relative to the user voice message number in this editing box.

• Voice Messages Number

It is possible to introduce the number for user voice messages in this editing box.

• Fax International Code

It is possible to introduce the international code relative to the user Fax number in this editing box.

• Fax Code

It is possible to introduce the national code relative to the user Fax number in this editing box.

• Fax Number

It is possible to introduce the number for user Fax in this editing box.

• Messenger Contact

In this editing box, it is possible to introduce the name or address of the Messenger Contact of the user in order send messages making use of the Microsoft MSN Messenger program.

• E-mail

The e-mail address of the user can be introduced into the editing box, in order to send e-mails.

7.3 SYSTEM > STOP “PWD 2”

Using the mouse to click on “Confirm”, the supervision program will be terminated. Password level 2 is required to perform this operation.

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8 ALARMS

The alarm situation is highlighted by a video message as well as the sound of a speaker.

In the event of an alarm, if the machine is in run time mode, it stops automatically in phase. If the alarm is such not to allow stopping in phase, the machine stops the same in the situation it finds itself.

When an alarm occurs , generally:

• control which alarm has occurred;

• check that the part of the machine affected by the alarm is in condition to re-start the cycle;

• reset the alarm by pressing the RESET button;

• start in run mode by pressing the START button.

INFORMATION

Every time the electric/pneumatic control board is accessed, the relative layout must be consulted

If alarms are present, the orange LED on the luminous column lights up.

8.1 LIST OF ALARMS

The following is stated for every alarm:

• the relative message that appears on the video;

• a description of the condition that causes the alarm;

• the effects that they cause on the machine status;

• the interventions and controls by maintenance technicians if the alarm should repeat frequently.

• Which element to control for troubleshooting:

• Electric control board: the electric control board must be accessed to check the components inside – this operation also means the wiring diagram must be consulted

• Pneumatic control board: the pneumatic control board must be accessed to check the components inside – this operation also means the pneumatic/P&ID layout must be consulted

• On the machine: it is necessary to check the components relative to the alarm in question on the machine directly – this operation means that the wiring diagram/pneumatic layout-P&ID must be consulted

BoxAlr1 Electric lock handling timeout

Description The rod that locks the front door does not rise in spite of the command given. The front door does not open.

Causes There could be a mechanical obstruction to the movement of the rod or an electric problem that does not allow the commend to reach its destination.

Reset Check that the rod is not obstructed mechanically; check the correct electrical connection.

What to check? Electric control board Pneumatic control board On the machine

BoxAlr3 Plexiglas front panel gasket timeout

Description The pressure switch signals that the air pressure is insufficient.

Causes The air pressure is insufficient to consider the gasket that locks the front Plexiglas panel as closed or the pressure switch is broken.

Reset Check that the pressure switch functions correctly, acknowledge and reset the alarm.


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BoxAlr4 No PLC input boards 24V

Description The 24V power supply is not present at the PLC input boards. The machine stops immediately.

Causes The automatic/fuse protection has intervened.

Reset Reset the 24V power supply at the boards, acknowledge and reset the alarm. Check that the protection fuse is not damaged.


BoxAlr5 No PLC output boards 24V

Description The 24V power supply is not present at the PLC output boards. The machine stops immediately.




BoxAlr6 No 24 V motors power supply

DescriptionThe 24V power supply is not present at the machine motors.

The machine stops immediately.




BoxAlr7 No 24 V instruments power supply

Description The 24V power supply is not present at the machine motors. The machine stops immediately.


Reset Reset the 24V power supply at the boards, acknowledge and reset the alarm. Check that the protection fuse is not damaged (access the electric control board).


BoxAlr8 Safety relay intervention

DescriptionThe emergency circuit pilot relay is disconnected. The line stops in emergency conditions and the air is removed from the cylinders. Any part of the machine can be accessed (except the electric control board) in safe conditions.

Causes A mushroom-shaped emergency button has been pressed or the control board is not live.

Reset

Release any mushroom-shaped emergency button that is pressed. Press the SAFETY RESET button to power the auxiliary circuits.

If, when pressing SAFETY RESET,the emergency circuit is not inserted (and, consequently the insertion of the main solenoid valve and voltage reset), check electrical continuity of the emergency circuit.


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BoxAlr9 No compressed air

Description The pressure switch signals that the air pressure is insufficient. The machine stops immediately, as occurs in emergency conditions.

Causes The air pressure is insufficient or the pressure switch is broken.

ResetPress the RESET button from the PC to silence the alarm and restore the pneumatic supply. Check that the air pressure is at least 6 bar. Check that the pressure switch functions correctly.


BoxAlr10 Fan Motor Circuit Breaker Release

Description The fan automatic protection switch has tripped.

Causes A motor has over-heated or short circuited.

ResetCheck that motor rotation is not obstructed. Reset the switch. Acknowledge and reset the alarm. Check the continuity of the electric power connections with the motor. Check the magnet-circuit breaker by accessing the electric control board.


BoxAlr11 Air inlet Valve Handling Timeout

Description The air inlet valve is at a standstill in an anomalous position or it does not move in spite of controls.

Causes The valve cannot complete its run or one of the sensors with which it is equipped does not function correctly.

Reset Check that nothing obstructs the valve run; check that the sensors are installed correctly and function. Acknowledge and reset the alarm.


BoxAlr12 Air outlet Valve Handling Timeout

Description The air outlet valve is at a standstill in an anomalous position or it does not move in spite of controls.

Causes The valve cannot complete its run or one of the magnetic sensors with which it is equipped does not function correctly.

Reset Check that nothing obstructs the valve run; check that the sensors are installed correctly and function. Acknowledge and reset the alarm.


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Station 1: Vials/syringes inlet unit

St1Alr1 Airlock: tray up/down cylinder timeout

DescriptionThe cylinder that determines the vertical movement of the slide that supports the vial/syringe inlet rack is at a standstill in an anomalous position, or does not move in spite of commands. The machine stops in phase.

Causes The cylinder has not managed to complete its run or one of the sensors with which it is equipped is broken.

ResetAcknowledge (ACK) and reset (Reset) the alarm. Press the START button to re-start. Check that the cylinder run is not obstructed. Check the correct functioning of the cylinder sensors and relative wiring.


St1Alr2 Airlock: internal door gasket timeout

DescriptionThe control that activates the gasket that locks the airlock internal door for introduction of the vials/syringes does not correspond with the status of the respective pressure switch. The machine stops in phase.

Causes The pressure switch may not be regulated or the gasket may have an air leak.

Reset Acknowledge (ACK) and reset (Reset) the alarm. Press the START button to re-start. Check the compressed air circuit.


St1Alr3 Airlock: external door gasket timeout

DescriptionThe control that activates the gasket that locks the airlock external door for introduction of the vials/syringes does not correspond with the status of the respective pressure switch. The machine stops in phase.




St1Alr4 Airlock: internal door sensors anomaly status

Description The airlock upper door (moved by the robot) is not detected in the open or closed position. The machine stops in phase.

Causes If the door has moved or one of the two sensors that detects presence is damaged, pay attention when manoeuvring inside the box, so as not to strike the door.

Reset MANUALLY re-position the door in one of the two positions. If the problem persists, control the correct functioning of the two sensors.


5252


Station 2: Dispensation unit

St2Alr1 Dispensation unit: filling unit ascent/descent timeout

DescriptionThe cylinder that determines the vertical movement of the slide that takes the vial/syringe in and out of the calibrator is at a standstill in an anomalous position, or does not move in spite of commands. The machine stops in phase.

Causes The cylinder has not managed to complete its run or one of the sensors with which it is equipped is broken.

ResetCheck that there are no obstacles in the cylinder run and that the sensors with which the cylinder is equipped are mounted correctly and functioning. Press the RESET button. Press the START button to re-start.


St2Alr2 Dispensation unit: peristaltic pump motor circuit breaker release

Description The peristaltic pump automatic protection switch has tripped. The machine stops in phase.

Causes The motor has over-heated or short circuited.

Reset Check that motor rotation is not obstructed. Reset the switch. Acknowledge and reset the alarm. Control the magnet-circuit breaker.


St2Alr3 Dispensation unit: peristaltic pump motor fault

Description The drive that interfaces the PLC controls with the peristaltic pump, signals an anomalous condition. The machine stops in phase.

Causes The peristaltic pump motor finds it difficult to rotate and over-heats.

Reset Check that pump rotation is not obstructed. Press the RESET button. Press the START button to re-start.


St2Alr10 Dispensation unit: out of range activity

DescriptionThe dose has been filled with a lower or higher activity with respect to the activity requested +/- the margin of error. The machine informs the operator via this alarm, but the cycle in progress continues.

Causes Activity requested too low, little activity in the BULK vial, margin of error set too low.

Reset Check the causes of that mentioned above, reset the alarm, press START.


5353


St2Alr11 Dispensation unit: peristaltic pump handling timeout

Description The peristaltic pump that allows filling of the doses is at a standstill in spite of the fact that the start control has been activated. The machine stops in phase.

CausesThe pump motor cannot start due to mechanical obstructions or due to malfunctioning of the drive (highlighted by the red LED switching on), or the magnetic sensor used to count the impulses is broken.

Reset

Check that motor rotation is not obstructed. Check the continuity of the electric power connections with the motor. Check the correct functioning of the magnetic sensor and relative wiring. Control pump activation.

Press the RESET button to exit the alarm condition. Press the START button to re-start.


St2Alr12 Dispensation unit: communication with BULK calibrator timeout

Description The system cannot communicate with the dose calibrator that measures the radioactive value of the Bulk. The machine stops in phase.

Causes A connection problem or a problem on the circuit board present in each dose calibrator.

ResetCheck the electric connection between the communication board inside the electric control board and the calibrator. If the problem persists, contact the Comecer after-sales service.


St2Alr13Dispensation unit:

communication timeout with filling calibrator

Description The system cannot communicate with the dose calibrator that measures the radioactive value in the vial/syringe in filling mode. The machine stops in phase.

Causes A connection problem or a problem on the circuit board present in each dose calibrator.

ResetCheck the electric connection between the communication board inside the electric control board and the calibrator. If the problem persists, contact the Comecer after-sales service.


St2Alr14 Timeout communication with calibrator console

DescriptionThere is no communication between the machine and the PITAGORA console: therefore the machine is not able to read the radioactivity inside every calibrator.

The machine stops during the cycle.

Causes A connection problem or an electronic problem

Reset Check the electrical connection between the communication board inside the electrical panel and the PITAGORA console; if the problem persists, please contact Comecer service.


5454


St2Alr15 Decaying time of the incongruent isotopes

Description The 2 calibrators are measuring different isotopes

Causes From the Pitagora console, the operator has measured 2 different isotopes; this is in con-trast with the correct functioning of the machine, which has to work with the same isotope.

Reset Properly select the using isotope by means of the Pitagora console


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Station 3: Drawing system group

St3Alr1 Drawing System: external door gasket timeout

Description The control that activates the gasket that locks the drawing system sliding door does not correspond with the status of the respective pressure switch. The machine stops in phase.




St3Alr2 Drawing System: pliers opening/closure timeout

DescriptionThe cylinder that opens and closes the pliers that remove and re-position the shielded container cap is at a standstill in an anomalous position or does not move in spite of commands. The machine stops in phase.

CausesThe solenoid valve has not managed to control the cylinder or one of the two sensors with which the pliers are supplied is broken or the compressed air system does not power the solenoid valve suitably.

ResetCheck that there are no obstacles in the cylinder run and that the sensors with which the cylinder is equipped are mounted correctly and functioning. Check the compressed air circuit. Acknowledge (ACK) and reset (Reset) the alarm. Press the START button to re-start.


St3Al3 Drawing System: pliers ascent/descent timeout

DescriptionThe cylinder that lifts and lowers the pliers that remove and re-position the shielded container cap is at a standstill in an anomalous position or does not move in spite of commands. The machine stops in phase.

CausesThe solenoid valve has not managed to control the cylinder or one of the two sensors with which the cylinder is supplied is broken or the compressed air system does not power the solenoid valve suitably.



St3Al4 Drawing System: vertical slide ascent/descent timeout

Description The cylinder that lifts and lowers the shielded container is at a standstill in an anomalous position or does not move in spite of commands. The machine stops in phase.

CausesThe solenoid valve has not managed to control the cylinder or one of the two sensors with which the cylinder is supplied is broken or the compressed air system does not power the solenoid valve suitably.



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St3Al5 Drawing System: horizontal slide in alarm

Description The slide that moves the shielded container horizontally is at a standstill in an anomalous position or does not move in spite of commands. The machine stops in phase.

Causes It is probable that there is a mechanical obstruction on the slide run or there has been a power cut and the slide can no longer determine its own position.

ResetCheck that there are no obstacles to the slide run, put the machine in manual functioning mode and then command the slide towards the cap remover/positioner position; acknowledge (ACK) and reset (Reset) the alarm. Press the START button to re-start.


St3Alr7 Drawing System: shielded container cap anomalous detection

Description The Drawing System pliers cannot remove the shielded container cap. The machine stops in phase.

CausesThe operator has not unscrewed the shielded container cap in the drawing system, therefore the pliers cannot remove it. Or it is possible that the fibres that detect the shielded container and its cap are not regulated properly.

ResetCheck that the shielded container cap has been unscrewed correctly. Check the correct functioning of the optic fibres that detect the shielded container and its cap.

Acknowledge (ACK) and reset (Reset) the alarm. Press the START button to re-start.


St3Alr8 Drawing System: horizontal slide circuit breaker release

Description The automatic protection switch of the electric actuator that moves the shielded container has tripped. The machine stops in phase.

Causes The motor has over-heated or short circuited.

ResetCheck that slide movement is not obstructed. Reset the switch. Check the continuity of the electric power connections with the motor. Control the magnet-circuit breaker.

Acknowledge and reset the alarm.


5757


Station 4: Autoclave unit

St4Alr1 Autoclave: door anomalous detection

Description The door that allows the robot access to the autoclave is at a standstill in an anomalous conditioner does not move in spite of commands. The machine stops in phase.

CausesThe solenoid valve has not managed to control the door or one of the two sensors with which the door is supplied is broken or the compressed air system does not power the solenoid valve suitably.

ResetCheck that there are no obstacles in the cylinder run and that the sensors with which the cylinder is equipped are mounted correctly and functioning.

Press the RESET button. Press the START button to re-start.


St4Alr2 Autoclave: generic alarm status

Description The autoclave informs Theodorico of an alarm condition.

Causes Refer to the autoclave manual.

Reset Eliminate the cause of the alarm in the autoclave, acknowledge and reset the alarm.


Station 5: Robot unit

St5Al1 Robot: pliers opening/closure timeout

Description The pliers that withdraw and deposit the vials/syringes is at a standstill in an anomalous position or does not move in spite of commands. The machine stops in phase.

Causes The solenoid valve has not managed to control the pliers or the sensor with which it is supplied is broken or the compressed air system does not power the solenoid valve suitably.




St5Al2 Robot: lock-nut remover/positioner pliers timeout

Description The pliers that removes and re-inserts the lock-nut into the vials is at a standstill in an anomalous position or does not move in spite of commands. The machine stops in phase.

CausesThe solenoid valve has not managed to control the pliers or one of the magnetic sensors with which it is supplied is broken or the compressed air system does not power the solenoid valve suitably.

ResetCheck that there are no obstacles in the cylinder run and that the magnetic sensors with which the cylinder is equipped are mounted correctly and functioning.



5858


St5Alr3 Robot: cap remover/positioner pliers timeout

Description The pliers that removes and re-inserts the cap into the vials is at a standstill in an anomalous position or does not move in spite of commands. The machine stops in phase.

CausesThe solenoid valve has not managed to control the pliers or one of the sensors with which it is supplied is broken or the compressed air system does not power the solenoid valve suitably.




St5Alr4 Robot: crimping pliers timeout

Description The crimping pliers are at a standstill in an anomalous position or it does not move in spite of commands. The machine stops in phase.

Causes The solenoid valve has not managed to control the pliers or the sensor with which it is supplied is broken or the compressed air system does not power the solenoid valve suitably.




St5Alr5 Robot: not in RUNNING

Description The robot does not respond to the interrogation of the machine controller (PLC). The machine is at a standstill in phase.

Causes The current has been restored. Wait for the robot to perform the initialisation procedure or the communication cable between the robot and the PLC is not connected.

Reset Check the communication cable between the robot controller and the PLC. Wait for completion of the initialisation procedure and then acknowledge and reset the alarm.


St5Alr6 Robot: positioning timeout

Description The robot has been commanded with a position, but it was not reached within the time established. The machine stops in phase.

Causes A robot speed that is too low may have been set.

Reset Control the speed value requested by the robot, then acknowledge and reset the alarm.


5959


St5Alr7 Robot: torque control alarm

Description

In order to minimise the effect of possible collisions on the machine, a function has been implemented that controls the torque absorbed by the robot motors instant by instant. If the torque absorbed exceeds the set value, the system considers that there has been a blow and immediately removes the power to the robot motors. The power is removed from the robot motors, the brakes are activated on the robot motors, the machine is stopped in phase.

Causes The robot has collided or the torque control value is too low.

ResetCheck that robot movement is not obstructed; control the value set in the “Torque control” parameter, acknowledge and reset the alarm. Do not leave foreign bodies inside the cell, which could interact with the trajectory of the robot.


St5Alr8 Robot: reset required, press the RESET button

Description The robot must be reset following re-ignition. The machine is at a standstill waiting for the operator to give consent for robot reset.

Causes Power to the robot electric control board has been applied, removed and then re-applied.

Reset Press the “reset” button present inside the "push button control panel" synoptic and then wait for the end of the resetting procedure.


St5Alr9 Robot: rephasing timeout

Description The robot has been commanded with the resetting procedure as requested but the same did not finish within the pre-established time. The machine stops in phase.

Causes A robot speed that is too low may have been set.

Reset Control the speed value requested by the robot, then acknowledge and reset the alarm.


St5Alr10 Robot: bar-code reading NOT taken place

Description The bar-code reader has not managed to read the label positioned on the vial/syringe in the hand of the robot. The machine stops in phase.

Causes It is probable that the label with pre-printed bar-code has not been applied correctly.

Reset

Acknowledging the alarm the machine will ask the operator if he wants to reject the vial or try and read the code again. In the first case the robot will take the vial to the elimination area and leave it, in the second case the robot will take the vial into the operator's view and will stop. The operator can thus check the application of the label and re-start the cycle using the START button.



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St5Alr11 Robot: lock-nut pliers closed but lock-nut NOT detected

DescriptionThe robot is holding a vial with lock-nut already removed, but the fibre present in the pliers that removes and inserts the lock-nut does not detect the presence. The machine stops in phase.

Causes It is probable that the pliers have not managed to remove the lock-nut or the fibre does not read correctly.

Reset

Check the correct functioning of the fibre and if functioning cannot be restored immediately, exclude it via the relevant box in the "ADVANCED SETTINGS" synoptic.

Press the ACK button; by acknowledging the alarm the machine will ask the operator if he wants to reject the vial or try and remove the lock-nut again. In the first case the robot will take the vial to the elimination area and leave it, in the second case the robot will take the vial into the operator's view and will stop. In this way the operator can check the status of the lock-nut on the cap and start the cycle again by pressing the Start button.


St5Alr12 Robot: cap pliers closed but cap NOT detected

Description The robot is holding a vial with cap already removed, but the fibre present in the pliers that removes and inserts the cap does not detect the presence. The machine stops in phase.

Causes It is probable that the pliers have not managed to remove the cap or the fibre does not read correctly.

Reset

Check the correct functioning of the fibre. If functioning cannot be restored immediately, exclude it via the relevant box in the "ADVANCED SETTINGS" synoptic.

Press the ACK button; by acknowledging the alarm the machine will ask the operator if he wants to reject the vial or try and remove the cap again. In the first case the robot will take the vial to the elimination area and leave it, in the second case the robot will take the vial into the operator's view and will stop. In this way the operator can check the status of the lock-nut on the cap and start the cycle again by pressing the Start button.


St5Alr13 Robot: lock-nut pliers open but lock-nut detected

DescriptionThe pliers that remove and insert the lock-nut into the vials is open but the fibre with which it is supplied detects the presence of a lock-nut between the pliers. The machine stops in phase.

Causes It is probable that the fibre does not read correctly.

ResetCheck the correct functioning of the fibre and if functioning cannot be restored immediately, exclude it via the relevant box in the "ADVANCED SETTINGS" synoptic. Acknowledge and reset the alarm. Press the START button to re-start.


6161


St5Alr14 Robot: cap pliers open but cap detected

Description The pliers that remove and insert the cap into the vials is open but the fibre detects the presence of a cap between the pliers. The machine stops in phase.

Causes It is probable that the fibre does not read correctly.

ResetCheck the correct functioning of the fibre. If functioning cannot be restored immediately, exclude it via the relevant box in the "ADVANCED SETTINGS" synoptic.

Acknowledge and reset the alarm. Press the START button to re-start.


St5Alr15 Robot: no motors power supply

Description The robot motors have no power. The machine stops in phase.

Causes It is probable that the door of the Theodorico is not completely closed.

Reset Close the door and check door sensor functioning.


St5Alr16 Robot: electric control board circuit breaker release

Description The robot controller automatic protection switch has tripped. The machine stops in phase.

Causes A robot controller has over-heated or short circuited.

ResetReset the switch. Acknowledge and reset the alarm.

Control the magnet-circuit breaker.


St5Alr17 Robot: optical fibre reading anomaly

Description According to the process controller, the robot holds a vial but the fibre present in the robot pliers does not detect the presence. The machine stops in phase.

Causes The fibre does not read correctly or the system has not been able to grip the vial.

Reset Check the correct functioning of the fibre. If functioning cannot be restored immediately, exclude it via the relevant box in the "ADVANCED SETTINGS" synoptic.


6262


St5Alr18 Robot: lock-nut detection anomaly in lock-nut remover/positioner pliers

Description The robot is holding a vial with lock-nut but the fibre present in the pliers that removes and inserts the lock-nut detects the presence. The machine stops in phase.

Causes The fibre does not read correctly or the system has not been able to put the lock-nut back onto the vial.

Reset


Press the ACK button; by acknowledging the alarm the machine will ask the operator if he wants to reject the vial or try and insert the lock-nut again. In the first case the robot will take the vial to the elimination area and leave it, in the second case the robot will take the vial into the operator's view and will stop. In this way the operator can check the status of the lock-nut on the cap and start the cycle again by pressing the Start button.


St5Alr19 Robot: cap detection anomaly in cap remover/positioner pliers

Description The robot is holding a vial with cap but the fibre present in the pliers that removes and inserts the cap detects the presence. The machine stops in phase.

Causes The fibre does not read correctly or the system has not been able to put the cap back onto the vial.

Reset


Press the ACK button; by acknowledging the alarm the machine will ask the operator if he wants to reject the vial or try and insert the cap again. In the first case the robot will take the vial to the elimination area and leave it, in the second case the robot will take the vial into the operator's view and will stop. In this way the operator can check the status of the cap in the vial and start the cycle again by pressing the Start button.


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8.2 LIST OF MESSAGES

BoxMsg1 Security bypass

The user has disabled the safety controls that the machine follows in order to avoid mechanical crashes. In manual functioning mode with the safety devices excluded, the machine can be given commands that are potentially dangerous for itself. The operator is responsible for ensuring this does not happen.

St1Msg1 Airlock: close external door

This message informs the operator that the vials (syringes) insertion pre-chamber door is open. The entry of the rack with the empty vials (syringes) is not possible unless the door is closed.

St1Msg2 Airlock: tray inlet request

This signal informs the operator regarding acceptance by the system of the tray ascent request. When the start button is pressed again, the tray will be recalled inside the cell.

St1Msg3 Airlock: tray outlet request

This signal informs the operator regarding acceptance by the system of the tray descent request. When the start button is pressed again, the tray will be recalled outside the cell.

St2Msg1 Dispensation unit: waiting for data from scada

The machine has taken a vial (syringe) in correspondence with the filling station (inside the dose calibrator) and waits for the scada (PC program) to communicate the data with which the vial (syringe) will be filled.

St2Msg2 Dispensation unit: start stand-by from scada logger manager

The machine has concluded the vial (syringe) filling cycle and is waiting for the scada (PC program) to communicate that recording has taken place of the data in the production data logger. Only at this point will the vial (syringe) be withdrawn from the filling station.

St3Msg1 Drawing System: NOT ready to receive

This message signals that the discharge station is not in the correct position to receive the vial (syringe) from the robot.

St3Msg2 Drawing System: inner door cap removal request

In order to continue its cycle, the discharge station is waiting for removal of the cap by the robot,

which separated the box from the drawing system.

St3Msg3 Drawing System: inner door cap insertion request

In order to continue its cycle, the discharge station is waiting for insertion of the cap by the robot,

which separated the box from the drawing system.

St3Msg4 Drawing System: vial/syringe stand-by

This message signals that the shielded container has been taken to the position in which it receives the vial (syringe) from the robot.

St3Msg5 Drawing System: remove shielded container

The machine has concluded vial (syringe) discharge into the shielded container and with this message informs the operator that the container can be removed and if necessary, insert another.

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St3Msg6 Drawing System: close Plexiglas door

The machine informs the operator that the Plexiglas door is open, which allows access to the drawing system.

St4Msg2 Autoclave: sterilisation in force

If the autoclave is present, this message appears to signal the work status of the same.

St4Msg4 Autoclave: last sterilisation NOT performed

The last sterilisation did not occur correctly. The operator will control the status of the autoclave and will start a new sterilisation cycle.

St5Msg1 Robot: manual movement NOT allowed

The operator has requested manual movement of the robot, which cannot be performed in order to prevent mechanical crashes.

St5Msg2 Robot: no detection by optic fibre

The robot has withdrawn a vial but the fibre with which it is supplied does not detect the presence.

It is the operator's responsibility to control the presence/absence of the vial (syringe) and, if present, regulate the fibre or by-pass it using the relevant tool in the "ADVANCED SETTINGS" synoptic).If the vial (syringe) is not present, inform the machine using the relative vials/syringes insertion/removal command.

SVMsg1 Recipe end: select a new one

The machine has completed filling of all doses requested by the lot being worked. This message asks the operator to start working a new lot (or also the same one by pressing the “EXECUTE THIS RECIPE” button).

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9 ATTACHMENTS

9.1 ATTACHMENT 1 - “REPORT DESIGNER” GUIDE

9.1.1 Introduction

The Report Designer is an extremely powerful instrument that has been integrated into THEODORICO to give users the possibility to autonomously create reports relative to the databases of THEODORICO itself, without having to purchase additional software packets The Report Designer libraries are therefore installed with THEODORICO completely free of charge and to not require any enabling with license in order to be used.

Below find a brief description regarding the fundamental passages necessary for the creation of a minimum report.

9.1.2 “Report Designer” Start

The Report Designer can be recalled via the “Edit Print Layout” command which appears in the “Recipe” synoptic menu. In this case, the Report Designer will be opened and the report can be edited:

The Report Designer opens showing the “Tool Box” on the left and the “Report Explorer”, “Field List” and “Property Grid” windows on the right. The central part displays the report layout.

The report opens with the connection to the database already configured. This allows to have the list of references to the data table of the original object (Data Logger/Recipe table, Trace DB of the variable or Historical Log) in the “Field List” window, i.e. the list of table fields.

The report is made up from “Bands”, which can be inserted using the “Insert Band” command accessible with a click of the right hand button on the mouse on the report layout area.

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The Bands available are:

• Top Margin: just one per page. Represents the upper limit of the report page

• Report Header: just one per report. It is printed first of all, only in the first page of the report

• Page Header: it is the page header and is printed on every page, at the top

• Group Header: it is the header of a group and there may be more than one in a report. Represents the start of a group of data

• Detail: contains the data to be displayed

• Group Footer: close a group. Always corresponds to a Group Header

• Report Footer: it is printed at the end of the report, on the last page

• Page Footer: closes every page of the report

• Bottom Margin: just one per page. Represents the lower limit of the report page

To build up an extremely simple report, only the Band Detail is necessary. The fields to be shown can be inserted by simply dragging them from the “Field List”. In this mode, following the report, the fields inserted will be displayed, for all records present in the table.

Filters

The “FilterString” property can be used to filter the data (from the Property Grid window) of the xtraReport (select xtraReport in the Report Explorer window). The property must only contain the criteria of the expression WHERE (E.g. [col] > 0, where “col” is the name of a table data column).

Groups

A Group Header Band must be inserted and the “GroupFields” property used to set the field according to the field according to which the data is grouped The order criteria can also be specified in the same property.

Synthesis of the data

The report can carry out synthesis operations (sum, count, average...) on data groups. To do this, insert a “Label” type object, connected to a field in the Field List window. The “Summary” property of the “Label” allows to set the type of synthesis to be realised via the relevant dialogue window that contains:

• Bound field: name of the field on which the operation must be performed

• Summary function: type of operation to be performed

• Format string: type of formatting of the results. It is also possible to add the unit of measurement as text

• Ignore NULL values: specifies whether to ignore the records with NULL field value

• Summary Running: defines the ambit in which to perform the operation. Assumes the values:

• None = no calculation

• Group = performed for all members of a group. At the start of the successive group it value is reset

• Page = carried out for values present on a page

• Report = carried out for all values of the report

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9.1.3 Example of creation of a Report

Now let’s see how to realise a report using Report Designer to display the data recorded by a Data Logger:

1) Firstly, create a new project and insert a Data Logger to record three temperatures. Let’s define the three Float type variables, which will be called “Temp_A”, “Temp_B” and “Temp_C”. Now add the three columns to the Data Logger, set a recording time of 1 minute and generate the table using the “Create Table” command from the “Database Settings” of the Data Logger.

2) Now let’s realise the report. By clicking using the mouse on the “Edit Report File” command of the general properties of the Data Logger, a window will be opened for editing the Report Designer. The ODBC connection to be used will already be automatically passed to the Report Designer and therefore the structure of the Data Logger table with relative fields will already be available in the “FieldList” window.

3) Initially the central part of the window, i.e. the work area for the creation of the report, will appear completely empty. It is in fact necessary to add the different sections of the report one at a time.

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4) Therefore, start to insert the sections or Band to be shown in the report. Normally the most important Band is the “Detail” because it is that where the data to be shown is inserted. To insert a Band use the right button on the mouse to click on the report work area and select “Insert Band”. Now let’s add the “TopManager” Band. Only one of these bands can be inserted per page and represents the upper limit of the same. Add a horizontal line inside the Band and a text box where “Movicon” will be placed. To do this, select “Line” from the “Standard Controls” window, positioned on the left of the editor window, and trace a horizontal line inside the Band. Select the “Label” object and insert it inside the Band. To modify the properties of a control, just select it and use the “Property Grid” window or click on the arrow that appears in the top right of the control in order to access its main properties. Select “Label” and insert the “Movicon” text into the “Text” property.

5) Insert the “ReportHeader” Band. This band represents the header of a report and will be printed at the start of the same only on the first page. For example here we can define the title of the report. Add another “Label” and customise the dimensions, colour and text.

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6) Insert the “PageHeader” Band. This Band represents the page heading and is printed at the top of every page. In the example the date of printing the report is inserted. We will put a “Label” field with “Printing Date” and a “PageInfo” field in which it will be possible to display the date and time by selecting “DateTime” in the properties of the object. For this field, also define the formatting with which the date and time must appear.

7) Insert the “GroupHeader” Band. This Band represents the header of a group and there may be more than one in a report. Represents the start of a group of data. In the example, just one group is inserted. The purpose of the report to be realised is to display a table with data taken from the database. In this Band there must be a line with the header of the table columns. Therefore add a “Table” object, withdrawing it from the “Standard Controls” window. The insertion of the object creates three columns by default. However, we require four, therefore select the object and using the right key on the mouse to click we add a column via the “Insert - Column To Left” command. Now just define the dimension of the column and insert the text to be displayed using the properties of every cell. The texts for the four columns are: “Date Time”, “Temp_A”, “Temp_B” and “Temp_C”.

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8) Insert the “Detail” Band. This Band contains data that must be displayed for the group. Here we must create a table with the same dimensions as those inserted into the “GroupHeader”. For easiness, let’s copy and paste the table already defined in the “GroupHeader”. At this point, we must associate the database filed, from where the data has been taken, to every cell in the table. Select the first cell from the left and open the properties window. In the “Data Binding” property we will select the field of the “LocalCol” table.

Carry out the same operation for the other three columns, associating the “Temp_A”, “Temp_B” and “Temp_C” fields. Using the properties of the individual cells, also define the format of the data, which will be “Data” for the “LocalCol” column while it will be the “Float” type for the other three.

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9) Insert the “GroupFooter” Band. This Band closes a group and always corresponds to a “GroupHeader”. In this Band we will display the average of the three values extracted for the three temperature columns. As already performed, insert a table with four columns. In the first field we will only add the “Average Values” text. Select the second field from the table and the properties window, click on the “Summary” field. Another window will open where it is possible to define the formula to be applied to the field. The windows must be filled-in as follows:

• Bound field: select the field in the table onto which the formula must be applied, in our case “Temp_A”

• Summary function: select the type of function to apply, in our case “Avgas”

• Format string: select the type of data format, in our case “Float”

• Ignore NULL values: enable this check box if any null values are to be ignored

• Summary Running: select the ambit in which the operation is to be performed, in our case “Group”

Repeat the same operation for the other two fields in the “Temp_B” and “Temp_C” table. If necessary, apply a background colour to the summary table.

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10) Insert the “ReportFooter” Band. This Band is printed at the end of the report, on the last page A field will be introduced into this band for any operator notes. We will simply insert a “Label” and three lines, modifying them so that they are dashed.

11) Insert the “PageFooter” Band. This Band closes every page of the report. A field will be introduced into this Band to display the page number. We will add a “Label” with “Page” text and a “PageInfo” field, in which the type of data to be displayed can be selected, e.g “NumberOfTotal” (displays the current page and the total number of pages).

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12) Insert the “ButtonMargin” Band. Only one of these bands can be inserted per page and represents the lower limit of the same. A horizontal line is added inside the Band like that inserted in the “TopMargin” Band.

13) At this point the report is terminated and if there is already data present in the database a preview of the report can be seen by clicking on “Preview” positioned on the bar at the bottom of the Report Designer window.

It is however possible to make previews of the report inn any phase of the creation of the report, thus allowing to immediately check the result that is obtained with the insertion of several Bands and controls.

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14) Save the report and close Report Designer to go back to the Movicon project. At this point, a new synoptic will be inserted into the project. The following objects will be added inside the synoptic:

• a “Logger-Recipes Data Window”, to which the Data Logger will be associated previously created, to display the data recorded. Using the “Print” button of the window it will be possible to print the report directly without displaying the preview (the printer pre-defined in the operational system will be used)

• three Potentiometers or Display for modification of the three temperature variables “Temp_A”, “Temp_B” and “Temp_C”

• a button to which the “Report-Recipes type command can be associated”. In the command, select Data Logger created previously and in the “Action” field select “Display”. Using this button, the report can be opened as a preview

It is now possible to run the report and after having recorded several data the report can be tested.

In the example just realised, all Bands available have been inserted in the report, but as already said at the start this is not a mandatory procedure. The programmer can decide which Band to use according to requirements.

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9.2 ATTACHMENT 2 - “CRYSTAL REPORT GUIDETM”

9.2.1 Introduction

Crystal Report™ is a user-friendly powerful instrument for the creation of graphical bases intended for data lists, tables, reports and anything else required to “present” the database data tables realised with the Movicon recording instruments. The report pages realised with Crystal Report™ will have the “.rpt” extension. These reports must be generated using this instrument. It must be purchased separately and will be connected to the data tables generated with Movicon. Movicon supports the 10.0 or successive version of Crystal Report™,

9.2.2 Creation of a Report using Crystal Reports

Below find the procedure used to obtain data reports via the integration of Crystal Reports with Movicon. Remember that the version required of Crystal Reports is 10.0 or successive. It is supposed that a project must be created containing a Data Logger that records three Movicon system variables, in order to simulate a random distribution of values recorded at intervals of five seconds from each other. The project must be started at least once (with ALT-F12 or appropriate run button) to allow Movicon to create the database. The next step envisions the use of Crystal Reports for the realisation of the report requested.

A dialogue window will be shown on start-up of the program, which requests what type of report to create: select “Standard” and click on “Ok” to continue.

Crystal Reports: New Project

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Now a list of types of connections to database will be shown, organised according to a tree diagram: expand the “Create new connection” node and select “ODBC (RDO)”. At this point a list of connections already existing in the computer will appear, among which there will also be that created previously by the project, which will have the name defined as “Name Project_DLR”. By clicking on “Next” the User Name and Password will be requested for the database: leave these fields empty and click on “End”.

Crystal Reports: Create New ODBC Connection

At this point, by selecting the pre-selected ODBC connection, the list of the names of the tables present inside will be listed (in the example in the figure, the table is called “LogExample”, as the name of the DataLogger). Click on the button with the right hand arrow to add the element to the list of the tables selected and click on “Next”.

Crystal Reports: Add table

In the next page the fields present in the table previously selected will appear in the list on the left. By clicking twice on the fields with the left key or selecting them and clicking on the right arrow, the fields will be added to the right hand list that contains the fields of the data base, which will be effectively shown in the report.

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Crystal Reports: Add Fields to be displayed

Clicking on “Next” there is the possibility of grouping the data connected according to one or more columns and, on the next page, to define the filters on the data. Finally, it is possible to select a template for displaying the data on the last page. To create a simple list without any graphical element, select “No template” from the list.

Crystal Reports: Select Template

Clicking on “End” the report that has just been created will appear, via the guided procedure. Using the functions of Crystal Reports it will now be possible to adapt the report to personal requirements, adding information to the data or calculations such as sums of the values, averages and standard deviations (See the Crystal Reports documentation for information). Save the report obtained in a file to end the creation procedure.

Crystal Reports: Result

It is now necessary to connect the report file to the Movicon Data Logger. Open the project and display the Data Logger Properties window in question. In the “General” properties, click on “CRW File” and select the Crystal Reports file (.rpt) created previously. Clicking on “Ok” the name of the file will be displayed among the properties of the Data Logger. In this way, it will be possible to display the report directly from the synoptic also during the execution phase. To do this, add a button to the synoptic and select the Report command, specifying “display” as action and the name of the Data Logger as the object. In the execution phase, by clicking on the button, the Movicon Report Viewer will be opened.

Movicon: Choice of the File Report

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