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2011 COMECER S.P.A.

| ALL RIGHTS RESERVED TUTTI I DIRITTI RISERVATI


Via Maestri del Lavoro, 90 - 48014 Castel Bolognese (RA) Italy
http://www.comecer.com E-mail: comecer@comecer.com
phone (+39) 0546 656375 - fax (+39) 0546 656353
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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INDEX
1 GENERAL .....................................................................................................................................................................5
1.1 MENU MAP ..................................................................................................................................................................................................... 5
2 MAIN ............................................................................................................................................................................6
2.1 MAIN - F1 ......................................................................................................................................................................................................... 6
2.1.1 PUSH BUTTON CONTROL PANEL .................................................................................................................................................... 6
2.1.2 MAIN CONTROL PANEL .................................................................................................................................................................... 11
2.1.3 FILLING KIT DETAIL ............................................................................................................................................................................. 12
2.1.4 BULK DRAWING ................................................................................................................................................................................... 14
2.1.5 FILLING DRAWING .............................................................................................................................................................................. 17
2.1.6 MACHINE STATUS DISPLAY WINDOW: SYRINGE FRACTIONING ...................................................................................... 19
2.1.7 MACHINE STATUS DISPLAY WINDOW: VIALS FRACTIONING ............................................................................................ 20
2.1.8 RECIPES MANAGEMENT ................................................................................................................................................................... 25
3 DECAY UTILITY .........................................................................................................................................................29
4 PRINT LAYOUT ..........................................................................................................................................................30
4.1 EDIT PRINT LAYOUT .................................................................................................................................................................................. 30
4.2 SET PRINT LAYOUT .................................................................................................................................................................................... 30
5 RECORD DATA ..........................................................................................................................................................31
5.1 RECORD DATA > LOGGER - F2 PWD 1.............................................................................................................................................. 31
5.2 RECORD DATA > FILLING REPORT - F3 PWD 1 ............................................................................................................................. 32
5.3 RECORD DATA > DISCHARGE REPORT - F4 ...................................................................................................................................... 33
5.4 RECORD DATA > BULK LOG .................................................................................................................................................................... 34
6 SETTINGS ..................................................................................................................................................................35
6.1 SETTINGS > SETTINGS - F5 PWD 1 ................................................................................................................................................... 35
6.2 SETTINGS > ADVANCE SETTINGS - CTRL + F5 ............................................................................................................................... 38
6.3 SETTINGS > MANUAL PWD 1 .............................................................................................................................................................. 40
7 SYSTEM .....................................................................................................................................................................41
7.1 SYSTEM > LANGUAGE .............................................................................................................................................................................. 41
7.1.1 SYSTEM > LANGUAGE > ENGLISH PWD 0 .............................................................................................................................. 41
7.1.2 SYSTEM> LANGUAGE > ITALIAN PWD 0 ................................................................................................................................. 41
7.2 SYSTEM > USER ........................................................................................................................................................................................... 41
7.2.1 SYSTEM > USER > LOGIN PWD 0 ................................................................................................................................................ 41
7.2.2 SYSTEM > USER > LOGOUT PWD 0............................................................................................................................................ 43
7.2.3 SYSTEM > USER > NEW USER PWD 2 ........................................................................................................................................ 43
7.3 SYSTEM > STOP PWD 2 ......................................................................................................................................................................... 47
8 ALARMS ....................................................................................................................................................................48
8.1 LIST OF ALARMS ......................................................................................................................................................................................... 48
8.2 LIST OF MESSAGES .................................................................................................................................................................................... 63
9 ATTACHMENTS .........................................................................................................................................................65
9.1 ATTACHMENT 1 - REPORT DESIGNER GUIDE ............................................................................................................................... 65
9.1.1 INTRODUCTION ................................................................................................................................................................................... 65
9.1.2 REPORT DESIGNER START ............................................................................................................................................................ 65
9.1.3 EXAMPLE OF CREATION OF A REPORT ....................................................................................................................................... 67
9.2 ATTACHMENT 2 - CRYSTAL REPORT GUIDE
TM
.............................................................................................................................. 75
9.2.1 INTRODUCTION ................................................................................................................................................................................... 75
9.2.2 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 identifcation 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 efective 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 efective 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 felds:
isotope name;
calibration factor set for the Bulk calibrator (K1);
calibration factor set for the flling 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 flling 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 flling kit.
Da sintesi: it is used to command the valves in liquid arrival from the synthesis module confguration; the window
represented at the side opens through which the operator inserts a syringe that identifes the product that is being
transferred and 2 felds 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 flling 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 frst 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 specifc 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 feld 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 confguration.
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 flling kit. It can assume diferent confgurations depending on the kit efectively present on
the machine;
Background is also present for the vial in flling mode: background activity measured [MBq] by the calibrator before starting
to fll the vial in question.
The Skip flling button stops the flling operation in progress;
The Reject button labels the vial in flling mode as no good and it will be inserted in the rejects at the end of flling.
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 confgurations of the flling kit
Kit A with Bulk dilution
Kit A with fnal 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 ofset measurements correctly.
CON: Represents the specifc 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 ofset 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 Confg Mode button puts
the scales in confguration mode. In this mode the weight is not read by the machine but must be connected to the scales
via serial cable andinnovation software (installed on the machine PC) to confgure/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 Confg 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-flled 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 flter the Trace ID of the radio medicine
(feld 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 flling 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
ofset 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 (n cc/pump rev) set by the operator.
CON: Represents the specifc 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 flling 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 Confg Mode button
puts the scales in confguration mode. In this mode the weight is not read by the machine but must be connected to the
scales via serial cable andinnovation software (installed on the machine PC) to confgure/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 Confg 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 flling 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 flling station
3 Representation of vials/syringes inlet area
4 Representation of discharge area in shielded container
5 Representation of the flled syringe accumulation area
6 Representation of mother vial
7 Bulk representation
7
6
5
4
1 5
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 flled vials storage area
WITHOUT
AUTOCLAVE
NOT PRESENT
3
WITH
AUTOCLAVE
Representation of the rejected vials storage area
WITHOUT
AUTOCLAVE
Representation of the flled vials accumulation area
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Representation of the flling station
SKIP / SKIP FILLING: positioned in proximity of the flling area. Pressing this button interrupts any flling in progress.
The peristaltic pump stops and the vial being flled 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 fnished in the Bulk during fractioning.
REJECT: positioned in proximity of the flling area. Pressing this button, the operator asks the machine to place the
vial or the syringe in flling mode in the rejects area. The machine ends the flling in progress and then the robot will
withdraw the vial/syringe just flled 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 efective entry takes place when by placing the machine in automatic mode and in run time, the process controller
automatically
Infates the lower gasket
Waits for a time T set in the Standard Settings under Airlock Class Time,
Defates 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 efective 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
Infates the upper gasket
Defates the lower door gasket for operator access to the pre-chamber
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Representation of Vials/syringes Rack
Reference Description
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 flling 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 flling 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.
Reference Description
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 felds:
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 defned by the felds.
Code1,
Code2,
Activity Request: expressed in ml or in MBq; by clicking in correspondence with this feld, 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 feld.
If flling 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 flling, 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 feld, 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 flling, e.g. on three records with priority 1,2,3 that requested frst by the
system is that with priority 1.
If, instead, the bar code and connect flling with bar code options are enabled, then this feld assumes a diferent
meaning: a label must be applied to every vial to be flled (Print -> Current Record) containing all of the information of
the record being worked and in particular, also code128 of the priority feld. 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 flled frst is not that which will be discharged frst if there is the autoclave or if the discharge station is not
available when the dose has been flled.
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Reject after flling: if enabled, the vial in question will be flled and then placed inside the reject vials accumulation area.
Bubble point test after flling: if enabled, the vial in question will be flled and then placed on the flling needle to allow
the operator to test the flter.
Save As
Copy the entire lot being worked into a new lot defned by the user:
Follow the window
Pressing Yes, the program modifes the felds 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 confrmation 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 defne
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
feld 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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PRINT LAYOUT
4.1 EDIT PRINT LAYOUT
The Theodorico Report can be managed via Report Designer
1
;
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 fnal 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 fles can have diferent extensions.
fles crated with Report Designer have the .repx extension
fles created with Crystal Report have the rpt. extension
A report fle can be associated to a resource DataLogger/Recipe, to an object Historical Log Window and an object DB
Trace Window. When a report fle 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 fle has the.repx extension, Theodorico will perform the operation using the Report Designer libraries. If the fle
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 fle format, which the operator can select
through this menu.
1 For further information regarding the use of Report Designer and Crystal Report, see the fnal attachments
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RECORD DATA
5.1 RECORD DATA > LOGGER - F2 PWD 1
The Historical Log or Historical Archive of the events chronologically records all of the signifcant events that have taken
place on the machine managed by the project. Signifcant 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, flter 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 flling cycle< the data inserted concern:
User/operator logged into the system;
Identifcation of the dose produced via lot, code 1 and code 2;
Identifcation 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 flling 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 flling start;
Date and time of flling end;
Duration of the flling cycle;
Activity efectively 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;
Identifcation of the vial/syringe delivered via lot felds, code 1 and code 2;
Identifcation of the vial/syringe, containing the dose stated in the point above, using the pre-labelled bar-code;
Activity efectively inserted into the vial/syringe;
Total volume (isotope + physiological solution inserted into the vial/syringe);
Date and time of flling end;
Expiry date and time of the vial/syringe delivered (flling 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 felds shown are:
Date and time of discharge of the dose produced;
Identifcation of the operator that has used the machine;
Identifcation of the vial/syringe produced via lot felds, code 1 (name of the customer if defned in the customer Editor
window, customer address if defned in the customer editor window) and code 2;
Identifcation of the vial/syringe, containing the dose stated in the point above, using the pre-labelled bar-code;
Activity efectively inserted into the vial/syringe;
Total volume (isotope + physiological solution inserted into the vial/syringe);
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 flter the Trace ID of the radio medicine
(feld 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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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 diferent 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 flling 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 diferent 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 flling 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 flling station when approaching the fnal value to be flled;
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 flling 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 flling 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 flling using volume and not activity. It must be noted how in volumetric
functioning mode a request for 1 MBq in the request activity feld 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 diferent types associated to 2 diferent 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 feld, 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 flled 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 flled syringes if the drawing system is
not available. By enabling this box, the robot will withdraw the syringe from the flling station only if the drawing system is
available.
Autoclave enable
Use this box to inform the machine that the autoclave is present. Each flled 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 felds: isotope, expiry (only vial), lot, cod1 and cod 2 (only vial), identifcation, activity requested and
corresponding time, bar-code.
Box settings
Fan Speed
THEODORICO has an independent ventilation system that allows to keep the envisioned classifcation 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 modifed, are shown in the upper part of the Advance
Settings window.
If flling 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 fnal flling).
If dilution takes place in the bulk or in each individual vial flled, 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 flling 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 fbre 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 fbre does not function correctly, the machine goes into alarm conditions. In this case, for the time
necessary to adjust or replace the fbre, the operator can exclude reading of the same by the controller.
ATTENTION
With the fbre 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 fbre in proximity of the pliers that remove and insert the cap onto the vial, which detects the presence
of the cap itself. If this fbre does not function correctly, the machine goes into alarm conditions. In this case, for the time
necessary to adjust or replace the fbre, the operator can exclude reading of the same by the controller.
ATTENTION
With the fbre 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 fbre in proximity of the robot pliers, which detects the presence of the diferent 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 fbre to adjust or replace it, the operator can exclude reading of the
same by the controller.
ATTENTION
With the fbre 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 fbre in proximity of the upper cap of the drawing system, which detects its position. If this fbre does not
function correctly, the machine does not function correctly.
In this case, for the time necessary to intervene on the fbre to adjust or replace it, the operator can exclude reading of the
same by the controller.
ATTENTION
With the fbre 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 -> infate gasket
Of->defate gasket
4) Commands of the gasket positioned inside the box in proximity of the tray entry area
On -> infate gasket
Of->defate 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
On -> infate gasket
Of->defate 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 fgure above, all three gaskets are defated
as the of 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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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 defnes the reading and writing rights that user an perform on the diferent 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 modifed. 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 signifcant 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 frst 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 diferent 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 diferent 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 fgure 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 modifed.
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 modifed.
Eliminate: This button allows to eliminate the User or Group selected.
Load File: This button allows to load a user fle already present. The fles searched for are those with the .rtusers extension.
Save with name: This button allows to save the current project on fle, specifying a fle name. The .rtusers extension, if
not specifed, 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 modifcations will be lost.
?: This button opens the application help fle.
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Users Group
The following settings mask will be ofered 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 defne 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 modifed via the user properties.
Default Access Level: This property allows to defne 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 modifed via the user properties
(not managed by the software).
Password Duration (Days): This property allows to defne 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 of: In Run time mode, a password request always leads to the activation of a user Via the Enable Auto
Log of property, if activated, the Log of will be performed automatically from Movicon after the time set in the Logof
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 of 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 diferent user.
The Enable Auto Log of property for the user and the group and this setting is managed in OR, therefore it is sufcient
that one of the two properties is enabled.
Auto Log of after (sec): Using this property it is possible to set the time after which Movicon will perform Auto Log of
of any active user. Naturally this setting only has meaning if the Enable Auto Logof 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 of property associated to the individual User is disabled.
Users
The following settings mask will be ofered 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 feld 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 profle 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 feld 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 defne the Password Level to be associated to the user. By default the setting of this
feld 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 frst 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 defne 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 defne 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 of: In Runtime mode, a password request always leads to the activation of a user Via the Enable Auto
Log of property, if activated, the Log of will be performed automatically from Movicon after the time set in the Logof
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 of 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 diferent user.
The Enable Auto Log of property for the user and the group and this setting is managed in OR, therefore it is sufcient
that one of the two properties is enabled.
Auto Log of after (sec): Using this property it is possible to set the time after which Movicon will perform Auto Log of
of any active user. Naturally this setting only has meaning if the Enable Auto Logof 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 Modifcation: If enabled this property allows to act in a way that at the frst login of the user just
created, the user can modify his password. In this way, the user can set his own password diferent 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 Confrm, 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 fnds itself.
When an alarm occurs , generally:
control which alarm has occurred;
check that the part of the machine afected 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 efects 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 insufcient.
Causes
The air pressure is insufcient 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.
What to check?
Electric control board
Pneumatic control board
On the machine
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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.
What to check?
Electric control board
Pneumatic control board On the machine
BoxAlr5 No PLC output boards 24V
Description
The 24V power supply is not present at the PLC output 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.
What to check?
Electric control board
Pneumatic control board On the machine
BoxAlr6 No 24 V motors power supply
Description
The 24V power supply is not present at the machine motors.
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.
What to check?
Electric control board
Pneumatic control board On the machine
BoxAlr7 No 24 V instruments power supply
Description The 24V power supply is not present at the machine motors. 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 (access the electric control board).
What to check?
Electric control board
Pneumatic control board On the machine
BoxAlr8 Safety relay intervention
Description
The 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.
What to check?
Electric control board
Pneumatic control board
On the machine
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SOFTWARE MANUAL - Rev. 0
BoxAlr9 No compressed air
Description
The pressure switch signals that the air pressure is insufcient. The machine stops
immediately, as occurs in emergency conditions.
Causes The air pressure is insufcient or the pressure switch is broken.
Reset
Press 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.
What to check?
Electric control board
Pneumatic control board
On the machine
BoxAlr10 Fan Motor Circuit Breaker Release
Description The fan automatic protection switch has tripped.
Causes A motor has over-heated or short circuited.
Reset
Check 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.
What to check?
Electric control board
Pneumatic control board
On the machine
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.
What to check?
Electric control board Pneumatic control board
On the machine
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.
What to check?
Electric control board Pneumatic control board
On the machine
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SOFTWARE MANUAL - Rev. 0
Station 1: Vials/syringes inlet unit
St1Alr1 Airlock: tray up/down cylinder timeout
Description
The 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.
Reset
Acknowledge (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.
What to check?
Electric control board Pneumatic control board
On the machine
St1Alr2 Airlock: internal door gasket timeout
Description
The 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.
What to check?
Electric control board
Pneumatic control board On the machine
St1Alr3 Airlock: external door gasket timeout
Description
The 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.
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.
What to check?
Electric control board
Pneumatic control board On the machine
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.
What to check?
Electric control board Pneumatic control board
On the machine
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SOFTWARE MANUAL - Rev. 0
Station 2: Dispensation unit
St2Alr1 Dispensation unit: flling unit ascent/descent timeout
Description
The 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.
Reset
Check 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.
What to check?
Electric control board Pneumatic control board
On the machine
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.
What to check?
Electric control board
Pneumatic control board
On the machine
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 fnds it difcult to rotate and over-heats.
Reset
Check that pump rotation is not obstructed. Press the RESET button. Press the START button
to re-start.
What to check?
Electric control board
Pneumatic control board
On the machine
St2Alr10 Dispensation unit: out of range activity
Description
The dose has been flled 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.
What to check?
Electric control board Pneumatic control board On the machine
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St2Alr11 Dispensation unit: peristaltic pump handling timeout
Description
The peristaltic pump that allows flling of the doses is at a standstill in spite of the fact that
the start control has been activated. The machine stops in phase.
Causes
The 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.
What to check?
Electric control board
Pneumatic control board
On the machine
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.
Reset
Check 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.
What to check?
Electric control board
Pneumatic control board
On the machine
St2Alr13
Dispensation unit:
communication timeout with flling calibrator
Description
The system cannot communicate with the dose calibrator that measures the radioactive
value in the vial/syringe in flling mode. The machine stops in phase.
Causes A connection problem or a problem on the circuit board present in each dose calibrator.
Reset
Check 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.
What to check?
Electric control board
Pneumatic control board
On the machine
St2Alr14 Timeout communication with calibrator console
Description
There 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.
What to check?
Electric control board
Pneumatic control board
On the machine
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SOFTWARE MANUAL - Rev. 0
St2Alr15 Decaying time of the incongruent isotopes
Description The 2 calibrators are measuring diferent isotopes
Causes
From the Pitagora console, the operator has measured 2 diferent 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
What to check?
Electric control board Pneumatic control board On the machine
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SOFTWARE MANUAL - Rev. 0
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.
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.
What to check?
Electric control board
Pneumatic control board On the machine
St3Alr2 Drawing System: pliers opening/closure timeout
Description
The 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.
Causes
The 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.
Reset
Check 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.
What to check?
Electric control board
Pneumatic control board On the machine
St3Al3 Drawing System: pliers ascent/descent timeout
Description
The 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.
Causes
The 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.
Reset
Check 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.
What to check?
Electric control board
Pneumatic control board On the machine
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.
Causes
The 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.
Reset
Check 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.
What to check?
Electric control board
Pneumatic control board On the machine
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SOFTWARE MANUAL - Rev. 0
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.
Reset
Check 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.
What to check?
Electric control board Pneumatic control board
On the machine
St3Alr7 Drawing System: shielded container cap anomalous detection
Description
The Drawing System pliers cannot remove the shielded container cap. The machine stops in
phase.
Causes
The operator has not unscrewed the shielded container cap in the drawing system, therefore
the pliers cannot remove it. Or it is possible that the fbres that detect the shielded container
and its cap are not regulated properly.
Reset
Check that the shielded container cap has been unscrewed correctly. Check the correct
functioning of the optic fbres that detect the shielded container and its cap.
Acknowledge (ACK) and reset (Reset) the alarm. Press the START button to re-start.
What to check?
Electric control board Pneumatic control board
On the machine
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.
Reset
Check 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.
What to check?
Electric control board
Pneumatic control board
On the machine
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SOFTWARE MANUAL - Rev. 0
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.
Causes
The 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.
Reset
Check 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.
What to check?
Electric control board Pneumatic control board
On the machine
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.
What to check?
Electric control board Pneumatic control board On the machine
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.
Reset
Check that there are no obstacles in the cylinder run and that the sensors with which the
cylinder is equipped are mounted correctly and functioning.
Acknowledge (ACK) and reset (Reset) the alarm. Press the START button to re-start.
What to check?
Electric control board
Pneumatic control board On the machine
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.
Causes
The 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.
Reset
Check 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.
Acknowledge (ACK) and reset (Reset) the alarm. Press the START button to re-start.
What to check?
Electric control board
Pneumatic control board On the machine
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SOFTWARE MANUAL - Rev. 0
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.
Causes
The 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.
Reset
Check that there are no obstacles in the cylinder run and that the sensors with which the
cylinder is equipped are mounted correctly and functioning.
Acknowledge (ACK) and reset (Reset) the alarm. Press the START button to re-start.
What to check?
Electric control board
Pneumatic control board On the machine
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.
Reset
Check 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.
What to check?
Electric control board
Pneumatic control board On the machine
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.
What to check?
Electric control board Pneumatic control board
On the machine
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.
What to check?
Electric control board Pneumatic control board
On the machine
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St5Alr7 Robot: torque control alarm
Description
In order to minimise the efect 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.
Reset
Check 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.
What to check?
Electric control board Pneumatic control board On the machine
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.
What to check?
Electric control board Pneumatic control board On the machine
St5Alr9 Robot: rephasing timeout
Description
The robot has been commanded with the resetting procedure as requested but the same
did not fnish 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.
What to check?
Electric control board Pneumatic control board On the machine
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 frst 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.
Press the RESET button. Press the START button to re-start.
What to check?
Electric control board Pneumatic control board On the machine
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St5Alr11 Robot: lock-nut pliers closed but lock-nut NOT detected
Description
The robot is holding a vial with lock-nut already removed, but the fbre 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 fbre does not
read correctly.
Reset
Check the correct functioning of the fbre 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 frst 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.
What to check?
Electric control board Pneumatic control board On the machine
St5Alr12 Robot: cap pliers closed but cap NOT detected
Description
The robot is holding a vial with cap already removed, but the fbre 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 fbre does not read
correctly.
Reset
Check the correct functioning of the fbre. 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 frst 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.
What to check?
Electric control board Pneumatic control board On the machine
St5Alr13 Robot: lock-nut pliers open but lock-nut detected
Description
The pliers that remove and insert the lock-nut into the vials is open but the fbre 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 fbre does not read correctly.
Reset
Check the correct functioning of the fbre 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.
What to check?
Electric control board Pneumatic control board
On the machine
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St5Alr14 Robot: cap pliers open but cap detected
Description
The pliers that remove and insert the cap into the vials is open but the fbre detects the
presence of a cap between the pliers. The machine stops in phase.
Causes It is probable that the fbre does not read correctly.
Reset
Check the correct functioning of the fbre. 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.
What to check?
Electric control board Pneumatic control board
On the machine
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.
What to check?
Electric control board Pneumatic control board
On the machine
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.
Reset
Reset the switch. Acknowledge and reset the alarm.
Control the magnet-circuit breaker.
What to check?
Electric control board
Pneumatic control board On the machine
St5Alr17 Robot: optical fbre reading anomaly
Description
According to the process controller, the robot holds a vial but the fbre present in the robot
pliers does not detect the presence. The machine stops in phase.
Causes The fbre does not read correctly or the system has not been able to grip the vial.
Reset
Check the correct functioning of the fbre. If functioning cannot be restored immediately,
exclude it via the relevant box in the "ADVANCED SETTINGS" synoptic.
What to check?
Electric control board Pneumatic control board
On the machine
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St5Alr18 Robot: lock-nut detection anomaly in lock-nut remover/positioner pliers
Description
The robot is holding a vial with lock-nut but the fbre present in the pliers that removes and
inserts the lock-nut detects the presence. The machine stops in phase.
Causes
The fbre does not read correctly or the system has not been able to put the lock-nut back
onto the vial.
Reset
Check the correct functioning of the fbre. 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 insert the lock-nut again. In the frst 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.
What to check?
Electric control board Pneumatic control board
On the machine
St5Alr19 Robot: cap detection anomaly in cap remover/positioner pliers
Description
The robot is holding a vial with cap but the fbre present in the pliers that removes and
inserts the cap detects the presence. The machine stops in phase.
Causes
The fbre does not read correctly or the system has not been able to put the cap back onto
the vial.
Reset
Check the correct functioning of the fbre. 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 insert the cap again. In the frst 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.
What to check?
Electric control board Pneumatic control board
On the machine
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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 flling station (inside the dose
calibrator) and waits for the scada (PC program) to communicate the data with which the vial
(syringe) will be flled.
St2Msg2 Dispensation unit: start stand-by from scada logger manager
The machine has concluded the vial (syringe) flling 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 flling 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 fbre
The robot has withdrawn a vial but the fbre 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 fbre 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 flling 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 fnd 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 confgured. 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 felds.
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 frst of all, only in the frst 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 felds to be shown can be inserted by simply
dragging them from the Field List. In this mode, following the report, the felds inserted will be displayed, for all records
present in the table.
Filters
The FilterString property can be used to flter 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 feld according to the feld according
to which the data is grouped The order criteria can also be specifed 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 feld 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 feld: name of the feld 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: specifes whether to ignore the records with NULL feld value
Summary Running: defnes 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 lets 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. Lets defne 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 lets 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 felds
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 diferent 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 lets 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 frst page. For example here we can defne 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 feld with Printing Date and a PageInfo feld
in which it will be possible to display the date and time by selecting DateTime in the properties of the object. For this
feld, also defne 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 defne 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, lets copy and paste the table already
defned in the GroupHeader. At this point, we must associate the database fled, from where the data has been taken,
to every cell in the table. Select the frst cell from the left and open the properties window. In the Data Binding property
we will select the feld of the LocalCol table.
Carry out the same operation for the other three columns, associating the Temp_A, Temp_B and Temp_C felds.
Using the properties of the individual cells, also defne 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 frst feld we will only add the Average Values text. Select the second feld from the table and
the properties window, click on the Summary feld. Another window will open where it is possible to defne the formula
to be applied to the feld. The windows must be flled-in as follows:
Bound feld: select the feld 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 felds 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 feld 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 feld will be introduced into this Band to
display the page number. We will add a Label with Page text and a PageInfo feld, 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-defned in the operational system will be used)
three Potentiometers or Display for modifcation 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 feld 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 GUIDE
TM

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 fnd 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 fve 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 defned as Name
Project_DLR. By clicking on Next the User Name and Password will be requested for the database: leave these felds 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 fgure, 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 felds present in the table previously selected will appear in the list on the left. By clicking twice on the
felds with the left key or selecting them and clicking on the right arrow, the felds will be added to the right hand list that
contains the felds of the data base, which will be efectively 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 defne the flters 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 fle to end the creation procedure.
Crystal Reports: Result
It is now necessary to connect the report fle 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 fle (.rpt) created
previously. Clicking on Ok the name of the fle 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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