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TS Manager Manual, English

1. 5 16 POST CONFIGURATION 16 RUNNING THE PROGRAM FOR THE FIRST 17 OG IN PAGE 17 CREATING THE ADMINISTRATOR USER USER 17 LOGGING INTO THE PROGRAM ADMINISTRATOR hene nn nn nn nn nun usua uana nn 19 MAIN OPERATIONS AND BASIC 20 STARTING THE PROGRAM uet eut unice Dusk sies esta ab 20 THE MAN WINDOW in eect ou Gi memes IU eM I LOL DDR CU De OC D CL Ea a 20 THE STATUS BAR MAN WINDOW rn Mena 21 MANAGING THE ARCHIVE TABLE Sees eigens reales 21 EDITING AND DELE TING ENTRIES ct lese a Eee ee ee 21 TIME
2. 34 STARTING THE DATA LOGGERS 5 0 5 36 CONCEPT OF A Me TT OT LI T UU 36 STARTING A MISSION MISSIONS 36 SETTING THE CURRENT USE OF THE DATA LOGGER DEVICE CURRENT 06 1 38 REQUEST USER AUTHENTICATION WHEN STARTING A MISSION OPTIONS ADVANCED SECURITY ONLY ADMINISTRATOR USERS E 38 CHECKING THE DEVICES IN USE 5 rne 40 CHECKING THE 2 ae Ren 40 DELETING A DEVICE ONLY ADMINISTRATOR 5 5 nnn nnn nnns a hus anu sanus n a sauna snae 41 CHANGING THE CURRENT USE OF A DEVICE ONLY ADMINISTRATOR ADVANCED 05 5 41 STOPPING AND DOWNLOADING A MISSION 5 5 42 DOWNLOADING DATA FROM A DEVICE MISSIONS DowNroap eeeseeee nere nennen nnne nnn nnnm 42 USER AUTHENTICATION REQUEST WHEN DOWNLOADING DATA OPTIONS ADVANCED SECURITY ONLY ADMINISTRATOR USERS Tc PET 43 DOWNLOADING A MISSION STARTED USING A DIFFERENT DATABASE seesee nennen nnn n
3. P Om 24 ADMINISTRATOR s 24 ADDING A USER ONLY FOR ADMINISTRATOR ADVANCED USERS eee nee nnne nennen nnne nnn nnn anna nnn 24 DELETING A USER ADMINISTRATOR USERS ONLY e nennen nennen nnn nnn nnn nnn nus n nasa nuin asas n snas nana n 25 ENABLING AND DISABLING A USER ONLY ADMINISTRATOR 5 5 nnne nnn n nnn 25 MANAGING THE STATIONS 26 ADDING A STATION ONLY ADMINISTRATOR ADVANCED USERS eee 26 ASSOCIATING A STATION WITH A PC ONLY ADMINISTRATOR 05 5 nnne nna nnns nnne nnns 27 DELETING A STATION ONLY ADMINISTRATOR USERS uunnuunununnnunnnunnnnnunnnununnnnnnnnnanunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nenn 27 MANAGING THE PROFILES PROFILES eere rnnt reris 28 ADDING A PROFILE ONLY ADMINISTRATOR ADVANCED USERS eene enne nennen nnn nnn n nn nnne n nnn n nonna 28 PARAMETERS USED FOR ANAD SIS sa 29 DELETING A PROFILE ONLY ADMINISTRATOR USERS 4 e eene nennen nnn nnn
4. 11 SBERRSESTION EY 11 CLIENT SERVER INSTALLATION STANDALONE TYPE 11 CREATING THE DATABASE SQL SERVER CONNECTION TYPE 1 1 12 CLIENT SERVER CLIENT INSTALLATION MULTI USER TYPE 13 NETWORK ADMINISTRATOR TASK Sa a dude E LM MELLE aes 13 DATABASE CONNECTION SQL SERVER CONNECTION TYPE 13 DATABASE CONNECTION SQL SERVER CONNECTION TYPE 13 CLIENT SERVER INSTALLATION MULTI USER TYPE B 2 2 2 0 4 4 414144 441111 nen 14 NETWORK ADMINISTRATOR TASKS aus sla cal Le M P du L LII 14 CREATING THE DATABASE SQL SERVER CONNECTION 14 CONNECTING TO THE DATABASE SQL SERVER CONNECTION esee eene nnn nnn nnne nnns nnn 15 MODIFYING THE CONNECTION STRING ONLY FOR ADMINISTRATORS eere e enne nnne nnne nnne n nne nnne nnne 15 RECREATING THE DATABASE How GAIN ACCESS TO THE SQL SERVER CONNECTION WINDOW 15 PROGRAM UPDATE mM Eee ee N 15 SOFTWARE CONFIGURATION AND 16
5. a RN ERR 52 REMOVE A MISSION FROM A GROUP zii ea 52 IVIUETIGRAPH ANALYSIS 52 CHANGE GRAPH AREA SIZE icta ee uad Laure sa PIER 53 SHOW TE EE SEND Gent de Er er MM UEM E M o3 ZOOM Bc EN TTE DNE o3 ASSIGN A GROUP TOA CUSTOMFRIINSTR MENT s cia dile Dub s tas cade tua parade 54 IIGETIGRAPEHSSPATISTIOS desc safe 54 54 CALCULATING THEORETICAL TEMPERATURE FROM PRESSURE EXCLUDING CURVES AND GIVE THEM A 55 DATES Rec 55 SEAL A GROUP MP 56 PRINT A GROUP ud outer istud Eu ea ua Dem e E ip RD MM ME En 56 LOCATING A MISSION MISSIONS FILTER eere rrr 57 FILTERING MISSIONS BY MISSION START DATE FILTER Bv 4 57 FILTERING MISSIONS BY DEVICE TYPE FILTER Bv 57 FILTERING MISSIONS BY USER FILTER Bv START FILTER Bv 57 FILTERING BY PROFILE FILTER BY PROFILE as ee 58 How
6. SEE SOME OF THE MISSIONS nei 63 GET ERROR AFTER UPDATE OR RESTORE sixes vocccnveeusuewcscewcivecceccbcevedcesseddecddelwevescdevcccadececceeuesedeeecedousex MEE 63 6 64 TS Manager Tecnosoft s r l Tecnosoft s r l TS Manager 7164 License agreement Read this license agreement thoroughly before using the Software Using and copying this Software is subject to the acceptance of this agreement If you choose to refuse the following conditions please return this Software to the point of purchase for a complete refund This agreement involves Tecnosoft srl Redecesio di Segrate Milano Italy henceforth called Tecnosoft and the User be it a physical or juridical person for the following software products henceforth called T8 Manager Software TS Manager Software and any software product accompanying it Tecnosoft grants the user a non exclusive right to use a copy of the software on a single computer provided that the user accepts the following conditions 1 User license TS Manager Software is property of Tecnosoft and cannot be copied nor sold without the prior written authorization of Tecnosoft TS Manager Software is protected by Italian and European Laws and by International Treaties concerning intellectual properties 2 Additional licenses The purchase of additional licenses conveys the right to use TS Manager Software on a corresponding number of computers at the same time 3 Exclusion of li
7. s r l Managing the Profiles Profiles To be able to launch a mission on a data logger you will have to assign at least one profile by which data will be analyzed The profiles are identified by their name and hold a number of parameters that can be set by the user You may access the profiles by clicking on the Profiles button from the left menu The profiles are then selected when a mission is started and therefore avoid you having to input the parameters each time a new mission is started File Objects Actions Tools Help Add Delete Adding a profile Only Administrator Advanced users Click on the Add button to add a new profile and fill in the fields in the Profile window Name Mode STERILISATION 00 Start Time Discard Manual start Days Hours Min Sec F Startat End Time Discard Days Hours Min Sec e Ab Notes 2 8 ga d M gs 5 M 3 d Pod H Tecnosoft s r l TS Manager 29 64 Name a name assigned to the profile Mode The type of data logger to which this profile is assigned You will be presented with different options depending upon which type is selected Select Temperature 140 C 284 F for temperature up to 140 C data loggers Temperature 100 C 212F for temperature up to 100 C data loggers Pressure Temperature for data loggers that can read temperature and pressure Delay The delay which applies from t
8. 17 0172 17 0172 test mult Tecnosoft s r l TS Manager 21 64 The Status Bar Main window The bottom part of the main window is used to display information related to the program as well as to the user currently accessing the program Starting from the left hand side each panel of the status bar holds the program version station name name and surname of the current user privilege level of the current user archive that is currently selected barometric pressure reading taken from the sensor located in the hardware key and approximation of the height above sea level current date and time Managing the archive tables Once an archive is selected from the list the details pane in the middle will display the details and elements for the particular archive Depending upon the privilege level for the user new entries may be added or removed from the archive To add an entry in general you need to click on the Add button or select the menu item Actions Add to delete an entry select it from the list and click on the Delete button For each archive the different columns will display details for each element in the list Clicking on the column title will toggle the sorting of the elements by that column in ascending or descending order For example if you select Users and click once on First Name the users in the list will be sor
9. 15 00 00 15 05 00 15 10 00 15 15 00 15 20 00 15 25 00 15 30 00 15 35 00 15 40 00 15 45 00 15 50 00 15 55 00 Total Acquisition Date 8 Time From 19 11 2010 14 58 To 19 11 2010 15 55 Pressure bar Options X NS START MARKER Ga SS END MARKER 1 DU ARE MOU GRIDLINES 19 11 2010 15 00 20 30 83 C 1 001 bar 19 11 2010 15 45 56 31 77 1 008 19 11 2010 15 45 56 31 77 C 1 008 bar Time Seconds 00 45 36 TimeSpan 0 94 Abs S E 0 007 bar Abs S E Temperature Pressure PrintGraph Print Table ExportReport E SEL SY There is more than one way to precisely identify a point where a marker could be placed Firstly if you place the sensor on the plot line of the graph and wait for a while a tooltip will appear showing the date time and value at that point If the plot contains a large number of points it may be wise to zoom into the graph first to be able to identify a specific point Another method consists of placing the marker close to the point you require and then navigate left or right using the lt and gt buttons close to the CURSOR label to move left or right If you keep these buttons pressed the scrolling will be faster If you click on a point that lies between two acquisitions you could click on the gt lt button to be automatically Tecnos
10. Assign a group to a customer instrument In the General tab there are additional information that you can fill in type in additional Notes and assign the group to a Customer and or an Instrument Multigraph statistics Open the Statistics tab and apart from seeing the missions duration you can see some statistics such as maximum minimum and average for each curve Missions group Temperature C 02 30 00 03 00 00 ieg a nssalg 03 30 00 Duration 17 01 2012 01 29 06 17 01 2012 03 38 06 02 09 00 Date amp time format dd MM yyyy HH mm ss Value SterilDisk 1001002121 17 01 2012 01 32 19 Temperature C PressureDisk 1501002058 17 01 2012 01 29 06 Temperature C PressureDisk 1501002058 17 01 2012 01 29 06 Pressure bar SterilDisk 1001002308 17 01 2012 01 40 10 Temperature C SterilDisk 1001002316 17 01 2012 01 39 20 Temperature SterilDisk 1001002315 17 01 2012 01 30 43 Temperature Date amp time 17 01 2012 01 32 19 17 01 2012 01 33 06 17 01 2012 02 47 06 17 01 2012 01 40 10 17 01 2012 01 39 20 17 01 2012 01 30 43 Date amp time 17 01 2012 02 44 19 17 01 2012 02 40 06 17 01 2012 02 40 06 17 01 2012 02 40 10 17 01 2012 02 40 20 17 01 2012 02 45 43 Adding markers In the multigraph like in the single mission analysis you can place vertical markers in the tab Markers excluding the area at the extremes from result analysis such as FO overkilling and
11. TS Manager User Manual Date 24 07 2012 FDA 21 CFR Part 11 Compatible Software Software Version 2 2 2 64 TS Manager Tecnosoft s r l Tecnosoft s r l Via Galvani 4 20068 Peschiera Borromeo Milano ITALY tel 39 02 26922888 fax 39 02 26922875 e mail info tecnosoft eu web www tecnosoft eu Tecnosoft s r l TS Manager 3 64 CONTENTS 2 7 INTRODUC TON a eee MM 8 MAIN CHARACTERISTICS OF THE un nun nun nnnan mann ann mann nen 8 COMPATIBLE DEVICES zn r Se ee EL 8 How TO USE THIS MANUAL 9 HARDWARE 245 10 TT NETS 10 5 c E LUE DECRE ee 11 THREE POSSIBLE INSTALLATION
12. Name Address P IVA Missions 1 012 bar 5 Mt 150 m 27 01 2012 16 22 22 Adding a client Only Administrator Advanced users Click on Add to add a new client and fill in the appropriate fields in the Customer window which contains two fixed fields that cannot be changed the client s name or business name We suggest to use different names to be able to find easily each Customer and to use the filters in the proper way Address the client s address You may also select all the clients by clicking on the Select button in the Actions menu N B It is not possible to modify any of the above fields not even by an Administrator If you have made an error when adding the client you will need to access the program as an Administrator delete the entry and create a new client from scratch Tecnosoft s r l TS Manager 31 64 Customer Name General Hospital Address Milan Italy Adding an instrument Only Administrator Advanced users Select the client under which you would like to add an instrument then click on the instrument pane and click Add to add the new instrument Fill in the fields in the nstrument window that holds one standard and non editable field name Name the name assigned to the instrument We suggest to use different names to be able to find easily each Instruments and to use the filters in the proper way You may select all the instruments by clicking
13. You can also re zoom into a graph that has already been zoomed by following the same procedure described above To revert to the previous view click on the small buttons at the extremities of the 46 64 TS Manager Tecnosoft s r l scroll bars To return to the original graph you will need to click these buttons as many times as you have zoomed The horizontal and vertical zooms operate independently so you will have to press both buttons to revert on both axis To quickly revert to the original graph use the Reset Zoom button Setting the markers Markers are horizontal or vertical date amp time values that can be set directly on the graph These markers are used to exclude portions of the graph for a particular analysis or when calculating certain statistics From the lower pane Options X you can set two vertical markers for example one for the start and the other for the end of the process This means that you can only exclude two portions of the graph from the first acquisition to the first marker and from the second marker to the last acquisition of the mission You cannot perform an analysis on non contiguous portions of the graph You can also select whether the markers should refer to the temperature scale or the second channel s scale currently pressure from the bottom left area under the CURSOR label By positioning the cursor on the graph and clicking with the mouse you will see two perpendicular lines that indicate the positio
14. 11 2010 15 55 Pressure bar Options X SS START MARKER EDMARER f CORSO S ld oS ons GRIDLINES 19 11 2010 15 45 56 34 77 C 1 008 bar Time Seconds Temperature Pressure PrintGraph C Print Table Export Report TEEN resume AU OY e ORC EXKL PUE OL SEE e DERE SAE DEGAS PEE CE N ELIE eurer mre vua The Grid You can also set the grid of the graph In the Options X area set the grid specifying a value in seconds under the GRIDLINES label for the X axis and then click Set In the corresponding Y axis area Options Y set the grid value in degrees or bar according to whether you selected temperature or pressure and then click Set Analyzing data using the table Data tabsheet Click on the Data tabsheet to access the table of acquired values the report of the mission statistics as well as the results of the analysis performed on the mission from the selected profile parameters On the left you will see the table of values with date time temperature and the second channel readings if present Mission Statistics Data Statistics On the right hand side the Statistics pane shows the date and time for the start and end of the mission the duration and the total number of acquisitions made Further down for each channel you will see the maximum minimum and the average values Date amp Time Format indicates the format used to display date and time which is
15. SHOW FAILED MISSIONS SHOW FAILED 55 1 1 nennen nnn nnn 58 CONTROL OVER ALL THE OPERATIONS CARRIED OUT ACTIVITY 59 DATA BACKUP AND RESTORE OPTIONS BACKUP amp 60 BACKUP ONLY ADMINISTRATOR USERS anna bein eheu sone cse nee 60 RESTORE ONLY ADMINISTRATOR USERS Qu hal 60 RESTORING A BACKUP FROM AN OLDER VERSION asian bak oca er cra vum eroi coa pe eiua bu cwn 60 BACKUP IN A CLIENT SERVER INSTALLATION 2uanunnunnnunnunnnnnnunnnunnunnnnnnunnnnnnunnnnnnunnunnnunnunnnunnnnnnnunnnnunnnnunnnnun sene 60 RUNNING AN AUDIT LOGIN AUDIT zuuununonuununonnanunnunnnunnununnnnunnnnnnunnnnnnunsnnnnunnnnnnunnunnunnnn 61 DATABASE INTEGRITY TEST INTEGRITY CHECK ae ee 61 ADDENDUM Aic eset ee cere casco das Once do dS e Seed lites aeta 62 TROUBLESHOOTING moo su ised oa s codes ue tele cde 63 UNABLE TO LOAD DLL FTDA2XA DU ERU EI EE VER Pea Ph 63 SOL INSTALLATION ISSUES cc ann en ere UP Seo 63 TIMES AM NOT ABLE TO COMMUNICATE WITH THE DATALOGGERS eese nee nnnm nnm nn nnne nhe sne shes unes su ne nuns 63
16. a usns 48 48 EXPORTING BATA IN XME Mission DATA IREPORT i1 iita Ei 49 EXPORTING DATA IN EXCEL FORMAT MISSION Dara 10 nennen nnn nennen nnn rne nnns 49 PRINTING THE DATA MISSION 49 CHANGING THE HEADER IMAGE OF THE REPORT OPTIONS REPORT ONLY ADMINISTRATOR USERS 49 INCLUDING THE GRAPH IN THE REPORT HARD COPY OPTIONS REPORT ONLY ADMINISTRATOR USERS 49 INCLUDING THE TABLE IN THE REPORT HARD COPY OPTIONS REPORT ONLY ADMINISTRATOR 49 MARK A MISSION AS FAILED en ern 49 MULTIGRAPH MULTIPLE ANALYSIS OF THE MISSIONS 51 CREATION OF A GROUP E NA ND Cs 51 GROUP MODES ink imb usu anu 51 SINGLE ee RO M MI uM MM EI E 51 IVIULTIPEE PROCESSES ni DeC aides etii deck aea usata eR ecol Votis ee eaten sae codd e battuta dos cal 02 ADDING MISSIONS TOA GROUP
17. and time By means of the Fixed Time Mode tab you can specify a fixed precise date and time at which the mission will start On the right hand side you may fill in the custom fields for the mission or select a client by clicking on Client Instrument Select the Client and Instrument and these will appear at the top of the Details pane of the Mission Start window a n1 EE Detail Name Analysis 1 Analysis 2 Notes TEMPERAT FO temp multi F0 N Protocollo Delay Mode Fixed Time Mode Days Hours Min Delay 0 10 0 Days ANALYSIS Rate 0 0 N CC 121 111111111111 Days Hours Length 1 20 210 2 C 10 F0 Minimum Min 80 Manual start m Cutoff C 100 Start at close Click on Next to proceed If you are starting the data logger for the first time with the current database you will be asked to specify to what use you are putting the data logger For more information please refer to the chapter Setting the current use of the datalogger Device Current use p 38 The program will send the mission start parameters to the data logger and will show a window that holds a summary of the operation including some generic data as well as whether the mission was started correctly or not Click on Close to exit or on Start another to start a mission on another data logger The Missions archive will show a new
18. as they have sufficient privileges to do so To create new users access the program with the Administrator login and password Once you have access as an administrator you can create as many users as you require granting each one the appropriate privileges p 24 Refer to the following chapters to find out the characteristics of each user privilege level and other program functions 20 64 TS Manager Tecnosoft s r l Main operations and basic configuration Starting the program Once the PC has booted double click the TSManager icon to run the program or launch it from Start All Programs Tecnosoft TSManager TSManager Once the program loads you will see the main login page select the username from the drop down list and enter the corresponding password in the Password field Click on Login to proceed or Quit to exit the program TS Manager Version 1 0 0 5 JSMITH v FDA 21 CFR Part 11 Compatible Software TecnoS oft r l Via Galvani 4 20068 Peschiera Borromeo Ml ITALY Password www tecnosoft eu TSManager 1 0 0 5 15 03 2011 12 48 08 The Main window The main window will appear which is divided into different sections In the middle section you will see the details for the archive that is currently selected the required archive on the other hand may be selected using the buttons on the left hand side or else from the Objects menu The archives are Missions Devices Profiles Users
19. data loggers Missions After completing the stages described above you may proceed to use the main functions of the program that is the management of the data loggers and the analysis of the downloaded data Make sure the interface is correctly connected to the PC that the USB drivers are correctly installed and that the data logger is correctly connected to the interface The concept of a mission We can describe a mission as follows Once a data logger is started we can say that it starts a data logging mission that is a monitoring process that is well defined with a start normally the moment it is programmed and an end which could be the moment the data is downloaded or a pre programed end date and time Each mission is therefore identified by means of two main parameters the start date and time and the serial number of the data logger In fact it is practically impossible that there exist two missions that start at exactly the same time on the same day on the same data logger which holds a unique serial number Furthermore TS Manager also adds other parameters that identify the mission in more detail and therefore makes it easier to identify such as the station or user who started the data logger Starting a mission Missions Start Make sure the data logger is inserted in the interface connected to the PC and from the Missions archive click on the Start button from the Actions menu If the option that requires user authen
20. data loggers the probe tip should always be directed towards the USB connector See the images below to see how each type of data logger should be connected including the appropriate adapters where necessary for correct communication with the software Note that in all the images below the USB connection is facing upward Tecnosoft s r l TS Manager 35 64 PasteurDisk SterilDisk PasteurDisk Probe PasteurCyl SterilCyl PasteurDisk Jumbo SterilDisk Probe SterilDisk Jumbo PasteurDisk Can SterilDisk Can PasteurCyl Jumbo PressureDisk P Micro S Micro SterilCyl Jumbo It is also possible to connect a number of devices simultaneously and start them and download data in sequence one after the other Note in some special applications it will not be possible to insert the data logger in the interface for example when a data logger is purposely fixed to a dummy unit of a specific product and cannot be separated in these cases the Disklnterface will be supplied with a special connection cable with red and black crocodile clips The red one must be connected to the probe end or the face without the serial number for those version without a probe whereas the black one should be connected to the other end If you connect them incorrectly the interface will not be damaged but the PC will not be able to communicate with the data logger in this case simply invert the clips 36 64 TS Manager Tecnosoft s r l Starting the
21. directory for the data Once this is set click on Ok to apply the changes Mission Data Path Documents and Settings EAROS Dati applicazioni TeenosaftiTshManadgerWlissianDatat Calibration Path C Documents and Settings EARO03 Dati applicazioni TecnosaftiTsSManagervwcalibrationt Close Specifying the folder for calibration data Only Administrator users N B this option is not currently implemented although present in the software You can specify this folder however the functions related to it will not become available until an update is released The calibration folder holds the files that contain the calibration data for each data logger being used by the software The calibration data files are copied manually into this folder and will be supplied if required by Tecnosoft or downloaded via the web Access the Advanced tabsheet from the Options window click on Tools Options and in the Calibration Path section click on Browse to specify the folder to which you will copy have copied the calibration files Once set click on Ok to apply Applying changes to the configuration In general for the changes made to the configuration to take effect you need to close and restart TS Manager Manual To access the manual in PDF format click on Help Manual You will need to have Adobe Acrobat Reader to be able to view the manual Closing the program To exit the program click on File Exit The program will be
22. entry the column that holds the end time and date Stopped will appear red 38 64 TS Manager Tecnosoft s r l indicating that the mission is still running and has not been stopped If you start a new mission on a data logger that is acquiring the current mission which will be interrupted will not be closed and will appear open in the database Mission Start Started Interface Type Serial AAUSUADQ STERILDISK 1001001828 Setting the current use of the data logger Device Current use When a data logger is started for the first time or if a specific data logger is connected to the database for the first time TS Manager will ask you to specify the current task you wish to assign to the data logger For example if you are going to use it for a validation process you can type Validations in the Current Use field of the Device window The same window will hold more information pertaining to the data logger these cannot be modified Click Ok to confirm the current task If you need to change the current use parameter of the device refer to Changing the current use of a device p 41 If you click on the Certificate button you can view the calibration certificate for this device as long as you have downloaded the corresponding calibration file and saved it in the directory specified for the certificates p 23 If this button is disabled the file for the particular certificate has not been found in the calibration file d
23. indicating SQL Express 2005 could not be installed You need to install manually SQL Express 2008 64 bit p 10 If on the other hand you encounter problems after the installation this could be caused by a change in the installation procedure on behalf of Microsoft To install SQL correctly you will have to remove all components that use SQL on that PC This procedure must be carried out by your internal IT support personnel or the owner of the PC on which you are trying to install TS Manager The steps to be carried out are the following The files required can be found on the CD in Program Salfix 1 install Microsoft Windows Install Cleanup msicuu2 exe 2 once the installation is complete run the program from Start All Programs Windows Install Cleanup 3 scroll through the list that appears and select the MSXML x x entries where x x is the installed version and then click on Remove 4 reinstall SQL 5 if you are asked to install msxml6 core you will have to install it msxml6 86 At times am not able to communicate with the dataloggers When a communication error is encountered the reason could be one or more of many interface not found TecnoCOM Port TimeOut etc Ensure that the interface is correctly connected to the PC and that the datalogger is inserted the right way in the interface cradle or adapter if required Check that the datalogger is clean and dry especially near the isolating washers and t
24. larger flat end is connected to the USB port on the PC whereas the smaller end plugs into the USB connection on the Disklnterface As soon as the device is connected to the PC Windows will automatically detect it and will start installing the drivers You should proceed as follows depending upon the operating system you are using USB driver installation under Windows XP In the Add New Hardware window select No not now last option and click Next In the following windows keep selecting the last option available that is manual installation of the driver for expert users and click Next Make sure the installation CD is in the CD ROM drive and insert the following directory in the path field DADriversXXP 2000 32 bit note that your CD ROM drive might not be D and click Next If windows brings up a message warning you that the drivers are from an unsigned source click Continue anyway and after the installation is complete click Finish Note that due to the way USB devices are managed by Windows if you connect the interface to a different USB port on your machine you might be required to reinstall the drivers Note apart from the installation CD you may also find the drivers in the program folder and alternatively you can download them from the Tecnosoft website USB driver installation under Windows Vista 7 With these operating systems Windows will try to install the driver however the installation will fail Once you ar
25. nnm hn hannes unn esas 43 CHECKING A MISSION WITHOUT STOPPING IT OR DOWNLOADING DATA ee sene nennen nnn 43 ANALYZING DATA MISSIONS Saisie aac s van uS aL C sain Ceu Gar eus va Soa aod C sua caa b sua aera aie 44 REPORT TABSHBEET aude dcn Dire aC nein a Mq ctae HR a 44 ANALYZING DATA USING THE GRAPH GRAPH 5 1 1 nun nun nun nun 44 THE ZOOM FUNCTIONS OF THE GRAPH ZOOM xacs 45 SETTING THE MARKERS 46 E sec ares ETE PET EDEN een 47 Tecnosoft s r l TS Manager 5 64 ANALYZING DATA USING THE TABLE DATA 5 hann 47 MISSION STATISTICS DATA STATISTICS I esse 47 ANALYZING DATA USING THE PROFILES DATA PROFILES Ji iei enu ca b a e 48 ADDITIONAL POST MISSION NOTES DATA Post MISSION 48 CLOSING A MISSION PERMANENTLY nennen nnne nnn anna nua hus asu sanus a su sanus a auus
26. on the Select All button in the Actions menu If you select one or more instruments and then access the Missions archive you will only see those missions that have been effected on those specific instruments You may enable or disable the filters by client and instrument by clicking on the Toggle Filter button in the Action menu bar of the Missions archive N B It is not possible to modify any of the above fields not even by an Administrator If you have made an error when adding an instrument you will need to access the program as an Administrator delete the entry and create a new instrument from scratch Instrument Name Autoclave ABC123 32 64 TS Manager Tecnosoft s r l User customizable fields Customization The user may add up to 16 custom fields for the clients instruments and missions by means of the configuration window these fields will appear in the Client or Instrument windows or when a mission is started p 36 and the user can fill in those fields at that time We recommend to those users who are using TS Manager to monitor their own plants and processes to create a client entry for themselves so that they are able to keep a database of their own instruments and areas being monitored Adding custom fields Only Administrator users To add a new custom field select Options from the Instruments menu at the top and open the Properties tabsheet Three panes will appear Customers Instruments and Missions Clic
27. so on Refer to single mission markers to know how to set them p 46 140 120 100 70 5 80 T EO gt 40 20 0 01 30 00 02 00 00 General Statistics Markers Curves Data 8 analysis START MARKER mr 01 03 57 17 01 2012 01 46 07 2 30 00 END MARKER 17 01 2012 02 50 04 03 00 00 03 30 00 Tecnosoft s r l TS Manager 55 64 Calculating theoretical temperature from pressure excluding curves and give them a name In the Curves tab you can give a name to each of them in the blank field to their right each curve is identified by logger type and serial number To the left of each logger there are three columns which can have some coloured fields the colour identifies the curve on the graph The first one is for temperature the second one is for pressure and the third one is used to display theoretical temperature calculated from pressure in saturated steam environment so it can be used when temperature goes above 100 You can enable and disable each curve removing or displaying them from the graph _ Missions group ce e 9 pu gt 0 01 30 00 Temperature eg s nssalg 02 00 00 02 30 00 03 00 00 03 30 00 SterilDisk 1001002121 2 Temperature PressureDsk 150100205 SterilDisk 1001002308 SterilDisk 1001002316 Data amp Analysis The Data amp Analysis ta
28. that selected in the regional settings in the Windows control panel 48 64 TS Manager Tecnosoft s r l Analyzing data using the profiles Data Profiles In the area below labeled Profiles you can select the profiles you configured when starting the mission and view the parameters used and the results obtained from the analysis Result field In this area you can also select from the drop down list a different profile to that you configured when starting the logger to be used to analyze the data If you analyze data with a different profile to that programmed when starting the logger you will be able to view the results however these will not be saved in the database Additional post mission notes Data Post Mission Notes The user may also insert additional notes or comments related to the mission in the Comments field this is a free text area where the user may include notes or opinions on the data or analysis results that might be useful to a third person viewing the data at a later stage You may also add preset comments from the drop down list To add preset comments give a name to the comment by writing it in the drop down list field then add your comments in the text area and click on the button to add it to the list of preset comments delete a preset comment select it and click on the button If you modify a preset comment and would like to change the comment to include the changes click on the button Click C
29. the titles you will also see within brackets the name of the window or particular option that is being referred to N B this software must be installed and started for the first time by an Administrator possibly the person managing the particular PC or network especially for client server installations who will then assign the passwords and permissions to the other users of the system 10 64 TS Manager Tecnosoft s r l System Requirements Hardware Description Minimum Recommended Microprocessor 2 GHz 3 GHz Memory 1 GB 2 GB Video 1024x768 1260x800 2 free USB ports for the DiskInterface and for the USB hardware protection key Software Description Supported Operating system gt P u 17 The installation program will check whether NET 4 0 SQL Express 2008 already present on the system If not it will install them automatically The installation CD contains the installation files for SQL Express 2008 32 bit SQLEXPR32 x86 ENU EXE and SQL Express 2008 64 bit SQLEXPR x64 ENU EXE in the folder Program SQLExpress2008 The installation will check if you have a 32 64 bit system and will install the proper version if the check fails please install NET first and then the appropriate version of SQL for your system Tecnosoft s r l TS Manager 11 64 Installation and database setup Installation pre requisites The installation of TS Manager includ
30. user Default is Guest Expiry the date after which the user will no longer be able to access the program Once all the fields are complete click on Ok to apply N B It is not possible to modify any of the above fields not even by an Administrator If you have made an error when adding the user you will need to access the program as an Administrator delete the entry and create a new user from scratch Tecnosoft s r l TS Manager 25 64 Title First name Last name Mrs Harwood Login Password AHARWOOD gt gin Level Cli Administrator Deleting a user Administrator users only To delete a user you simply select the entry from the list and then click Delete N B you cannot undo this operation You will have to create a new user if you inadvertently deleted one Enabling and disabling a user Only Administrator users To change the state of a user select the user from the list and then click on the Status button from the top row 26 64 TS Manager Tecnosoft s r l Managing the Stations Stations A station is a terminal PC upon which TS Manager is installed The Stations function allows you to give names to each computer running TS Manager This will enable you to keep track of which computer started a specific mission Once you have created a station for each PC to actually assign the station to a specific PC you will need to set the the configuration parameters p 27 Y
31. will not be able to make use of all the program features If this occurs you will have to recreate the database and lose all the data up to then and repeat the operation to create an administrator user Expiry the date after which the user will no longer be able to access the program We suggest to input a very distance expiry range for the first Administrator Enabled This option is used to enable or disable the user Since we are creating the first Administrator user you must leave it enabled Title First name Last name John Smith Login Password JSMITH TT Level 0 Administrator v 31 12 2020 Enabled Click on OK to confirm the operation You will see that a new entry has been added to the Users list Now close program by clicking on File Exit TecnoSoft Manager 21 CFR Part 11 Compatible X Fille Objects Actions Tools Help Add Delete Status First name Last name Status Level Expiration John Smith Enabled Administrator 27 01 2020 14 33 Missions Devices Profiles Stations I 21 0 2 DEFAULT Maurizio Nicolini Administrator Users 1 013 bar 4 Mt 7 150 m 27 01 2012 14 33 51 Tecnosoft s r l TS Manager 19 64 Logging into the program Administrator User At this point the Administrator user should create all the database tables or at least create the list of users for the software who will then create the tables as long
32. 10 14 58 To 19 11 2010 15 55 Pressure bar Options X Ee START MARKER Ll o END MARKER iL CORSON GRIDLINES FE _ Time Seconds Temperature gt Pressure V PrintGraph Print Table Export Report The Zoom functions of the graph Zoom You can zoom into an area of the graph by clicking on it with the left mouse button and dragging it a grayed area will appear that will enclose the area to be zoomed Once the required area is selected release the button EIER Mission Data Report Graph Data Options Y to TOP MARKER 140 00 3 5 BOTTOM MARKER EB Y SPAN 120 00 3 Start Pressure 0 000 bar 400 00 2 5 e y 5 2 2 80 00 2 o E j 60 00 1 5 40 00 1 Ss LEGENDS Temperature Pressure 20 00 0 5 an EN 15 00 00 15 05 00 15 10 00 15 15 00 15 20 00 15 25 00 15 30 00 15 35 00 15 40 00 15 45 00 15 50 00 15 55 00 n e Total Acquisition Date amp Time From 19 11 2010 14 58 To 19 11 2010 15 55 Pressure bar Options X imum START MARKER SET ads END MARKER i s CURSOR GRIDLINES 191112010 15 45 56 31 77 C 1 008 bar Time Seconds Temperature Pressure O PrintGraph C Print Table Export Report Once zoomed vertical and horizontal scroll bars will appear so you can move through the graph at the selected zoom level
33. 995 a is e em n E Analyzing data using the graph Graph Tabsheet The graph is displayed by clicking on the Graph tabsheet In the main area you will see the plot or plots if more than one channel is being measured of the recorded data on the left hand side you will see the temperature scale whereas on the other end the scale for the second channel at present this could only be pressure in bar The blue plot refers to the temperature readings whereas the other channel is shown in green The horizontal axis displays the time at which the measurements were taken below this the global start and end date and time will be displayed This global time means that it does not include the time to discard from the start and end of the mission as set in the corresponding profile p 29 and neither the markers that you can set on the graph p 46 Tecnosoft s r l TS Manager 45 64 penam Report Graph Data Options Y o TOP MARKER 140 00 35 N N es Y SPAN 120 00 Start Pressure 0 000 bar 100 00 a f 9 d o 9 A 5 80 00 l amp a E E 1 5 4 2 LEGENDS Temperature Pressure 05 gt 45 00 00 45 05 00 45 10 00 45 15 00 15 20 00 15 25 00 15 30 00 15 35 00 15 40 00 15 45 00 15 50 00 15 55 00 Total Acquisition Date amp Time From 19 11 20
34. DiskInterface ts04diu and adapter ts10pcc ts10spca SterilCyl ts10sca ts10scg ts10scb ts10scc temperature DiskInterface tsO4diu and adapter PasteurDisk Jumbo ts01pdj1 temperature tsO4spdja tsO1pdj2 tsO1pdj3 ts01pdjd SterilDisk Jumbo tsO1sdj1 ts01sdj2 Tecnosoft s r l TS Manager 9 64 Interface Data logger Physical quantity measured ts01sdj3 ts01sdjd DiskInterface tsO4diu and adapter PasteurCyl Jumbo ts10pcj1 ts10pcj2 ts1cpcj3 ts10pcjd tsO4psmra S Micro ts01sm1 04spci temperature ts04spcja SterilCyl Jumbo ts01scj1 ts10scj2 ts10scj3 ts10scjd DiskInterface ts0Adiu and adapter P Micro ts01pm1 emparats DiskInterface ts04diu and adapter 1504 PressureDisk ts13prd temperature pressure How to use this manual This manual was designed to quickly give users the information needed to carry out specific tasks it is therefore not merely a list of program functions and furthermore the titles of each chapter section and paragraph have been chosen such that the user may immediately identify what is to be explained The sequence in which the chapters are presented follow a hypothetical standard sequence that would normally be followed when using the software from installation to configuration to starting and downloading data from the devices and ending with printing and managing reports Next to
35. FIRST ONE This type of installation has the following setup one PC will hold the database and will act as a server to the other client PC s The client PC s running TS Manager will then connect to the server to access the database First and foremost the installation on the server needs to be carried out The network administrator needs to to install SQL unless already present and needs to make note of the connection string that will be then passed on the the client PC s to enable them to have read and write access to the database After that the software can be installed on the other PC s The installation on the client machines can follow the instructions described for a Type A installation p 11 The database creation however will be different the first client PC will create the database directly on the server Type B The other clients will then connect to the database that has already been created by the first PC and will therefore be a type C connection as described above p 13 Network administrator tasks In this type of installation the network administrator needs to carry out additional tasks for two reasons each client PC needs to be given sufficient privileges to access the client server PC and to read and write data to the TSManager database on the client each client PC needs to be given the correct connection string that will enable them to access the database on the client server PC Creating the
36. OUT RE TYPE 22 SETTING THE TIMEOUT PERIOD ONLY ADMINISTRATOR USERS Anke ein 22 CHANGING THE LANGUAGE ONLY ADMINISTRATOR USERS uunuuanunanunannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnen 22 CHANGING THE TEMPERATURE MEASUREMENT UNITS CELSIUS FAHRENHEIT ONLY ADMINISTRATOR UsERS 23 SPECIFYING THE FOLDER TO WHICH DATA LOGGER MISSIONS ARE STORED ONLY ADMINISTRATOR USERS 23 SPECIFYING THE FOLDER FOR CALIBRATION DATA ONLY ADMINISTRATOR 5 65 nnn nnn nnn 23 APPLYING CHANGES TO THE 23 MANOA RR ae RER NEIL RC 23 CLOSING THE PROGRAM este seen nee 23 4 64 TS Manager Tecnosoft s r l USER PRIVILEGE EEVELS a M IM EA RUE 24 GUE cheers attested LI MEE IL LE 24 STANDAR PNE T m 24 Jo eco
37. Once the download is complete the Result window will appear displaying the basic information related to the data that has just been downloaded which are the profile used for the mission and in the result column the result of the mission based upon the parameters in the profile Click on Analysis to view the mission data Click on Exit to close this window you will be able to analyze the data later since the data that has been downloaded is accessible from the corresponding entry in the list displayed in the Missions archive Mission Stop Serial Current Use Hame Result Started Start Station Start User 1801001005 Autoclave valid Sterilisation FO Below Mini 15 09 2010 16 13 TECNOSOFT Mr John Smith Tecnosoft s r l TS Manager 43 64 User authentication request when downloading data Options Advanced Security only Administrator users The administrator may request that the user retypes the password each time a mission is to be downloaded This additional security option guarantees maximum security for the use of the system and its devices and reduces the risk of unauthorized operations To enable this option click on Tools Options access the Advanced tabsheet and click on the Require Authentication To Stop Mission option Options c UR Properties Advanced Report Customisation Backup amp Restore Database Test Force database check at program start Connection String Dat
38. Stations and Customers Each archive presents different options that may be accessed from the buttons above the main details pane or via the Actions menu item To configure the program on the other hand you need to access the menu Tools Options File Objects Actions Tools Help Start Download Filter Toggle Filter Failed Print Preview Group E Started Stopped Device Serial Missions Printed Custome Instrume N Protoc Station Stations Customers Activity Log 21 0 2 DEFAULT Maurizio Nicolini Administrator Missions 16 0172 16 0172 16 0172 150100 DEFAU 150100 DEFAU 17 0172 17 0172 100100 DEFAU 17 0172 17 0172 17 0172 17 0172 100100 test mult DEFAU 17 0172 17 0172 test mult 17 0172 17 0172 test mult 17 0172 17 01 2 test mult 17 0172 17 01 2 test mult 17 0172 17 0172 test mult 17 0172 17 0172 test mult 17 0172 17 0172 17 0172 17 01 2 test mult 17 0172 17 0172 IMS x 17 0172 17 0172 test mult ini 17 0172 17 0172
39. Tecnosoft s r l TS Manager 13 64 Client server client installation multi user type C TYPE A TS MANAGER TS MANAGER 78 CLIENT SERVER E CLIENT 4 TYPE C TS MANAGER TS MANAGER CLIENT li cd CLIENT In this type of installation the setup will consist of a PC upon which both the database and the software will be installed since the same PC will act as a database server and also as a client for one user and other client PC s that will connect to the database on the client server PC First and foremost the installation should be run on the client server PC where a type A installation described above should be ran p 11 Once this is complete you may proceed to install the software on the other client PC s You may follow the same procedure here since in reality it is the type of database connection that changes not the actual installation This will be of Type A for the client server and Type C for the client PC s Network administrator tasks In this type of installation the network administrator needs to carry out additional tasks for two reasons each client PC needs to be given sufficient privileges to access the client server PC and to read and write data to the TSManager database on the client server each client PC needs to be given the correct connection string that will enable them to access the database on the client server PC D
40. a Source ESQLEXPRESS Integrated Security True Station DEFAULT Advanced Security 4 Require Authentication To Start Mission Logout Timeout Minutes 60 7 Require Authentication To Stop Mission Mission Data Path C ProgramData TecnoSoftiTSManager MissionData Browse Calibration Path C ProgramData TecnoSoffiTSManager Calibration Browse Click on Ok to apply the changes Downloading a mission started using a different database If you try to download the data from a data logger that has been started using a PC that is connected to a different database TS manager will notify you that the start mission record is not present and therefore you will not be able to view the recorded data Checking a mission without stopping it or downloading data You may check a mission in progress without having to stop it simply insert the data logger in the interface and click on Preview in the Missions archive 44 64 TS Manager Tecnosoft s r l Analyzing data Missions To view and analyze the data of a particular mission click on the Analysis button after downloading the data p 42 or alternatively double click on the required mission in the Missions archive as long as the mission has been stopped in which case the start and end date and time will be shown in the Stopped column and displayed in green You cannot access a mission that has not been stopped Once a saved mission is opened the Mission Data wi
41. abilities Except for what stated by applicable laws in no case can Tecnosoft be considered liable for damages or losses direct or indirect including but not limited to loss or missing income suspension of activities loss of information or any other monetary or economical damage deriving from proper or improper use of TS Manager Software even if Tecnosoft has been advised of the possibility of such damages In any case the responsibility of Tecnosoft for such damages will be limited to the price paid for TS Manager Software This clause is applied even if the User does not accept TS Manager Software 4 Use of Software results It is User s responsibility to check that results given by TS Manager Software are correct and appropriate In no case should TS Manager Software be used if such use can be threatening to the health or life of human beings This clause is applied even if the User does not accept TS Manager Software 5 Updates If TS Manager Software is an update of a previous version the license is transferred from the old version to the update Only the update can be used unless the update is destroyed 6 Separation of components TS Manager Software is licensed as a single product Components cannot be separated 7 Limitations The User cannot convert decode decompile or disassemble TS Manager Software except for what is explicitly requested by applicable laws 8 64 TS Manager Tecnosoft s r l Introduction TS Manager
42. atabase Connection SQL Server Connection type A To create the database on the server PC follow the instructions described above p 12 Database connection SQL Server Connection type C After creating the database on the client server PC you may proceed to connect the clients to the client server database Your network administrator will provide you with the connection string that needs to be entered in the appropriate field in the SQL Server Connection window as well as ensuring that you have been granted sufficient privileges to access the database SQL Server Connection Manual Installation Connection String Create Database 14 64 TS Manager Tecnosoft s r l The steps to do this are after inserting the correct connection string select Manual Installation and de select the Create Database option click on Test Connection and once this turns green click on Test Database procedure was successful click on OK to run the program If this procedure fails make sure the connection string is correct and that the user of the particular PC has sufficient rights to access the client server PC Client server installation multi user type B C DATABASE TYPE B qe b SERVER TS MANAGER TYPEC TS FIRST CLIENT INSTALLED CLIENTS AFTER THE FIRST ONE TS MANAGER TYPE C TS MANAGER CLIENTS AFTER THE FIRST ONE CLIENTS AFTER THE
43. b holds many different tab one for each mission and each has all the data format and the result of each single analysis FO Overkilling etc in table Missions group Temperature C 0 01 30 00 Jeg s nssalg 02 00 00 02 30 00 03 00 00 03 30 00 General Statistics Markers Curves Data amp analysis SterilDisk 1001002121 17 01 2012 01 32 19 PressureDisk 1501002058 17 01 2012 01 29 06 SterilDisk 1001002308 17 01 2012 01 40 10 SterilDisk 1001002316 17 01 2012 01 39 2 Date amp Time 17 01 2012 01 32 19 17 01 2012 01 33 19 17 01 2012 01 34 19 17 01 2012 01 35 19 17 01 2012 01 36 19 17 01 2012 01 37 19 17 01 2012 01 38 19 17 01 2012 01 39 19 17 01 2012 01 40 19 Temperature C 18 68 19 11 19 26 19 31 19 41 19 46 19 55 19 60 19 64 Result OK E F0 minutes 123 37 56 64 TS Manager Tecnosoft s r l Seal a group You can seal a group just like how you would do that with single missions and the concept of this operation is the same p 48 Just click the Seal button in the Mission Group window to proceed Note sealed group cannot be deleted Print a group To print a group report just click on the Print button in the Mission Group window The report will include a first page with the group information then all the information for each mission the multigraph the single graph and if requested the data tables Te
44. closed 24 64 TS Manager Tecnosoft s r l Managing the users Users Once the program has been installed and the database and the administrator user have been created you may define the other users of the program and assign their privileges To be able to assign new users you will need to access the program as an Administrator or Advanced user although the Advanced user cannot add Administrator users or delete any entries from the lists User privilege levels TSManager caters for four levels of user each with increasing privileges up to the Administrator who has full access to the program functions and features The options and functions that are not available to the current user are not hidden or grayed out they are simply displayed in red If you click on these functions a message will appear informing you that you may not access the particular function due to restricted privileges Guest A guest user can only view the content of the archives This user may not carry out any of the program functions e g start and download data loggers and cannot manage the archives When an audit is carried out p 61 the user should access the program as a Guest user Standard Standard users have limited access to a number of functions for example they can start data loggers but cannot stop them Advanced An advanced user has access to most of the program functions but does not have complete control over the archives and furt
45. cnosoft s r l TS Manager 57 64 Locating a mission Missions Filter To locate a particular mission you can sort the list of missions from the Missions archive by clicking on the column headers p 21 you can also select the client and instrument from the Client archive p 31 and also filter the list by clicking on the Filter button In the resulting window you can select from various filter types enabling them by clicking on the corresponding name of the particular pane and then selecting the various options within that pane For example if you would like to locate a mission started within a certain time frame you can enable the first filter Filter By date and set the start and end of the required period in the two fields occupying this pane To apply the filter click OK To go back to the original view that displays all the missions click Filter again all the options will be disabled simply click on OK to return to the Missions archive will all filters disabled You can enable or disable the clients and instruments filter by clicking on the Toggle Filter button in the Actions menu of the Missions archive Below is a description of the various filter options MissionFilter Filter By Date From To venerdi 18 marzo 2011 Filter By Device Type Serial Humber Ll Filter By Start Station User Filter By Stop Station User Filter By Profile Filtering missions by mission start date Filte
46. d Device type Device serial number STOP Device stopped Device type Device serial number READ Reading N A N A N A ADD Record added Table name Record description ID Record DELETE Record deleted Table name Record description ID Record EDIT Record edited N A N A N A BACKUP Backup N A N A N A RESTORE Restore N A N A N A SETUP Sonnigaranen Changed option 1 Changed option 2 sanged option max change 3 options changed 3 TIMESY NC Clock error N A Last valid time and N A occurred date mE UserLOGIN is the login LOGFAIL Login failed UserLOGIN N A N A used to try to access the softw are SEALED Sealed mission ID sealed mission N A N A FAILED Failed mission ID failed mission N A N A CHA NGEUSE Device use Device serial N A N A changed number CHANGEUSERSTA TUS pos User Name ID user changed N A PRINTED Mission printed ID printed mission N A N A Tecnosoft s r l TS Manager 63 64 Troubleshooting The most common problems and their solutions are described below Unable to load DLL FTD2XX dll This error may appear when trying to connect to an interface This message indicates that the drivers have not installed correctly Try unplugging the USB cable and connect it to a different USB port to restart the driver installation SQL Installation issues If you are working with a 64 bit operating system SQL is probably already installed If this is not the case when the installation starts you will see an error message
47. d to access the program as an Administrator delete the entry and create a new station from scratch Tecnosoft s r l TS Manager 27 64 Associating a station with a PC Only Administrator users After creating all the stations required to identify all the computers that will access the TS Manager database you may now link the station to the corresponding PC Select Options from the Tools menu and then open the Advanced tabsheet In the database section next to the Station label select the station to which you want to assign the PC being used from the drop down list Click Ok to apply the change Once you change the station assigned to the PC TS Manager will ask you to close and restart the software Options ee Advanced Report Customisation Backup amp Restore Database Connection String Data Source XESQLEXPRESS Integrated Security True PEE E Ass DEFAULT Security JSMITH PC Require Authentication To Start Mission Logout Timeout Minutes 60 Require Authentication To Stop Mission Mission Data Path C ProgramData TecnoSoftiTSManager MissionData Calibration Path C ProgramData TecnoSoftiTSManagen Calibration Deleting a station Only Administrator users To delete a station select it from the list and click Delete N B you cannot undo this operation You will have to create a new station if you inadvertently deleted one 28 64 TS Manager
48. database SQL Server Connection type B After having installed the software on the first client PC the database needs to be created directly on the server It is very important that the correct connection string is used Select Manual Installation and enable the Create Database option Carry out the following tasks click on Test Connection if the operation fails the button turns red instead of green double check Tecnosoft s r l TS Manager 15 64 the connection string and that the user has sufficient privileges to access the server click on Execute to create the database on the server if the operation fails and the button does not turn green one of the possibilities is that we are trying to recreate a TS Manager database that already exists and it is not possible to delete the old one to create the new one Reasons for this could be that the user does not have sufficient privileges to delete it or that another user is currently connected to the database N B re creating a database will delete all the data and archives from the old database click on Test Database to verify that it is up and running SQL Server Connection Manual Installation Connection String Create Database Once this procedure is complete click on OK to launch the program Connecting to the database SQL Server Connection type C To connect to the database on the server please follow the instructions described in the
49. e Comments M 1 06 J PrintGraph Print Table Export Report Closing a mission permanently Seal After analyzing the data for a mission setting markers and adding comments as required you can close the mission permanently by clicking on the Seal button A confirmation message will appear and if you accept the mission can still be viewed printed or exported however you will not be able to perform further analysis using markers and comments After closing a mission in this manner you will note that the Sealed field for the corresponding mission in the Missions archive will be marked YES indicating the mission has been permanently closed Exporting Data Data can be exported in HTML or Excel format Tecnosoft s r l TS Manager 49 64 Exporting data in XML Mission Data Report To do this right click on Export Report at the bottom of the window you ll be asked where you want to save the xml file along with its style sheets You can save this file anywhere to be able to use the file and its contents liberally for example to publish them on a web page or insert them into a personalized report or presentation You may also change the appearance using style pages Exporting data in Excel format Mission Data Data To export data in excel format open the Data tabsheet and click on the Export to Excel File option a standard Windows save file window will appear Select the folder to which you wou
50. e PC a timeout feature has been added This means that if the software is not used and therefore the timeout period elapses the program will require the password for the logged user to be reinserted to allow more actions to be done in software In the password window that will remain on top of other windows the user may then either insert the password and click Ok to keep working or choose Quit to close the program Timeout Password Request Setting the timeout period Only Administrator users To change the timeout period select Options from the Tools menu and from the resulting Options window select the Advanced tab In the section labeled Security you will see the Logout Timeout Minutes option The default value is 15 minutes use the up and down arrows to change the value or enter it directly in the field The minimum timeout is 3 minutes Click Ok to confirm Backup amp Restore Database Connection String Data Source ESQLEXPRESS Integrated Security True Force database check at program start Station DEFAULT r Security Require Authentication To Start Mission Logout Timeout Minutes 60 Require Authentication To Stop Mission Mission Data Path CAProgramDataYTecnoSoftiTSManagenWdissionDatak Calibration Path CAProgramDataiTecnoSoftTSManager Calibration Changing the language Only Administrator users The TS Manager installation program installs all the available languages To change the lan
51. e discarded from the end of the mission The data is nevertheless recorded but the software will ignore them Notes here you can type in some notes to help you to remind the use of the profile while starting a mission these notes won t be printed in the report Analysis 1 2 you may select standard formula from the drop down menus with which to perform additional analysis some parameters cannot be modified by the user since fixed specific values are required The parameters shown may differ according to the logger type and the type of analysis chosen and will only be shown after a specific choice has been made You may add profiles without including any predefined analysis Parameters used for analysis Below is a list of parameters that can be used for the different analysis Not all parameters will be displayed according to the type of analysis Note Z the value of Z used for FO FN and PU calculations N the value of N used for FO FN and PU calculations FO PU Minimum the minimum value of FO or PU that you wish to reach at the end of the process Cut Off the temperature value below which the data points should not be considered when deriving the calculation for FO o PU By default this value is 0 Max Temp C maximum temperature to be used when performing an Overkilling analysis Min Temp C minimum temperature to be used when performing an Overkilling analysis Duration Minutes duration in minutes to be used whe
52. e left mouse button Drag the mouse up and down to change size Show the legend Open the General tab and enable the Show Legend option to display them legend on the of the graph Missions gre p ___ SterilDisk 1001002121 1 7 01 2012 01 32 emperature 2 PressureDisk 1501 002058 17 01 2012 01 29 06 Temperature __ PressureDisk 1501002058 17 01 2012 01 29 06 Pressure bar SterilDisk 1001002308 17 01 2012 01 40 10 Temperature C isk 1001 on 6 1770172012 mun emperature C 22 SteriD isk 1001 00231 5 17 01 2012 Dt Temperature C 22 SterilD isk 1001 1 7 01 2012 01 38 emperatur d 1001 002233 7 01 2012 emper Temperature C amssaig SterilDisk 1001 60230 7 01 2012 01 34 02 Temperature C SterilD isk 1001002319 17 01 2012 01 emperature C isk 1001 002285 1 7 01 2012 01 31 emperatur aten isk 1001 002333 i 7 01 2012 01 37 33 Temperatu 0 0 SterilDisk 1001 002268 D 2012 01 30 00 02 00 00 02 30 00 03 00 00 03 30 00 01 36 40 Temperature Statistics Markers Curves Data amp analysis Multigraph V Show legend Single process time synchronization Reset zoom Zoom in the graph It is possible to zoom an area of the graph of the groups exactly like for the single graph window p 45 To restore original size click on Reset Zoom in the General tab 54 64 TS Manager Tecnosoft s r l
53. e nnns n nu sa nasa nasa su sanus asus a su sanus nuni 29 MANAGING CLIENTS AND THEIR EQUIPMENT 5 30 ADDING A CLIENT ONLY ADMINISTRATOR ADVANCED 5 5 1 a nu sanas a nun 30 ADDING AN INSTRUMENT ONLY ADMINISTRATOR ADVANCED USERS 1 eene enne nenne nnn nnn 31 USER CUSTOMIZABLE FIELDS 2 nnn nhan nun nana nana nnn 32 ADDING CUSTOM FIELDS ONLY ADMINISTRATOR USERS namens 32 DELETING A CUSTOM FIELD ONLY ADMINISTRATOR USERS nennen he een 33 DELETING A CLIENT ONLY ADMINISTRATOR 5 65 nennen 33 DELETING AN INSTRUMENT ONLY ADMINISTRATOR USERS 33 INSTRUMENTS AND ACCESSORIES uununonunnonannununnunnnunnunnnunnunnnunnnnnnnnnunnunnnnnnnunnnnunnnnunnnnnnnnn 34 CONNECTING THE DISKINTERFACE seen 34 USB DRIVER INSTALLATION UNDER WINDOWS 2 04 1 161600000000 34 USB DRIVER INSTALLATION UNDER WINDOWS 5 7 1 074 60 1 1 1000000 34 UNSDIEGESSEUNINSTABERTIONGE etr wear antes 34 CONNECTING THE DEVICES
54. e presented with the option choose to install the drivers from a specified path Ensure the installation CD is in the drive and in the path field input the following folder path D Drivers Vista_7 32 and 64 bit your driver might not be D and click Next If windows brings up a message warning you that the drivers are from an unsigned source click Continue anyway and after the installation is complete click Finish Note that due to the way USB devices are managed by Windows if you connect the interface to a different USB port on your machine you might be required to reinstall the drivers Note apart from the installation CD you may also find the drivers in the program folder and alternatively you can download them from the Tecnosoft website Unsuccessful installation If the installation does not complete successfully go to Control Panel System Device Manager or Hardware Device Manager for Windows select USB Ports right click the SDI entry and select Update Driver and follow the instructions above Connecting the devices The data loggers must be inserted in the interface in a particular manner if you connect the device incorrectly it will simply not be able to communicate with the PC however there is no risk of damage to the device In general the side of the data logger on which the serial number is engraved should face the end of the interface that holds the label Serial number here In the case of cylindrical
55. e tables are empty and there are no users present you will need to create an administrator user The login page Once the program starts whether you double clicked on the TS Manager icon on the desktop or after clicking OK following the SQL Server Connection window you will be presented with the login page If this is the first time you are accessing the program after creating the database the user list will be empty simply leave the Login and Password fields blank and click Login to access the main page of the software jat TS Manager Login Version 2 2 0 0 d FDA21 CFR Part 11 Compatible Software S r1 Via Galvani 4 20068 Peschiera Borromeo MI ITALY Password ww w tecnosoft eu SS rn TSManager 2 2 0 0 20 07 2012 18 01 47 Creating the Administrator user User page After the very first program start when the archives are still blank you will access the program with full privileges see p 20 and therefore all the functions and options of the program will be available as if a virtual Administrator accessed the program The very first operation that needs to be carried out is the creation of a true Administrator User after which you should logout and then login again using the new credentials To do this click on the Users button on the left and then the Add button at the top TecnoSoft Manager 21 FR Part 1 Compatible REGE X File Objects Actions Tools Help Add Delete Sta
56. ect two or more and compare them on a single graph File Objects Actions Tools Help Add Delete Group Printed Customer Instrument Sealed ie 1 5 5 a M lt S 3 r T 2101 DEFAULT Maurizio Nicolini Administrator Groups 1 001 bar 96 Mt 150 m 23 01 2012 17 45 54 Creation of a group To create a group select the Groups archive and click on Add In the Group window type in the Name of the group additional Notes and the Mode Group modes A group can have two modes depending on the nature of the selected missions to be compared Single process If the missions come all from the same process and made with different loggers the mode is called Single Process In this case them missions are synchronized using the time line 52 64 TS Manager Tecnosoft s r l Multiple Processes If the selected missions refer to different processes made in different periods even with the same loggers select Multiple Processes you ll be asked to set a temperature to be used to synchronize the curves starting from the first time that temperature is recorded on each curve Synchronization Temperature paure Name Multigraph Notes Mode Multiple Processes Temperature synchronization T Syncrhonization Temperature 40 Adding missions to a group Once a group is created select the Missions archive and select using CTRL and SHIFT on your keyboard t
57. edited every user must access the software by means of a username and password client server installation and shared database multi user access graded user access levels different permissions for each level all the operations carried out using the software are recorded in a log that cannot be modified data is analysed by means of pre set or personalized parameters pre and post mission comments may be added to the logged data data is displayed in spreadsheet or graph format with zoom feature personalized reports may be printed data may be exported in HTML and xls MS Excel format for system validators a list of clients and the equipment they validate including associations with the data loggers used to validate the systems Compatible devices TS Manager is a flexible software and system and in the future more Tecnosoft devices will be added At present the devices and their accessories outlined in the list below are compatible with the system the ordering code is in brackets Interface Data logger Physical quantity measured PasteurDisk 1501 PasteurDisk Probe ts01pdp temperature SterilDisk ts01sd DiskInterface ts04diu SterilDisk Probe ts01sdp temperature PasteurDisk Can tsO1pdds ts01pddm ts01pddl ts01pddd SterilDisk Can ts01sdds ts01sddm ts01sddl ts01sddd temperature PasteurCyl ts10pca ts10pcg ts10pcb
58. es the installation of some additional required components if these are not already present on the system they will automatically be installed before it actually installs TS Manager The component pre requisites are Microsoft NET Framework 4 0 or later Microsoft SQL Server Express 2008 or later Three possible installation scenarios There are three possibles scenarios under which the program may be installed client server the database server and the software program client are installed on the same PC and no other PC s need to access the database client server client one PC will have a client server installation whilst one or more additional PC s will connect as clients to the client server PC in order to access the database server client the database is installed on a single PC acting as a server which is accessed by multiple client PC s acting as clients N B to be able to install this software you must access your Windows operating system as a user that is able to install programs generally an Administrator When installing we recommend that you install the software for all users Everyone and not only for the active user When installing under Windows Vista or 7 you may be at times requested to authorize certain operations to complete the installation Once the installation is complete before starting the program on client machines you will need to insert the USB hardware protection key USB protec
59. f the operating procedures should be maintained TS Manager complies with this requirement by keeping a log of all the operations carried out by the program from access of the database by a particular user to starting missions to analyzing data Click on the Activity Log archive to view the history of these operations After the Date amp Time and Activity columns you will see an additional three columns nfo 1 2 and 3 where the details on the particular operation are shown According to the particular operation Activity the information displayed will change For example if the Activity is Added Hecord in Info 1 we will see the name of the archive in which the record was added If Activity is Device Started Info 1 will show the type of data logger and nfo 2 will show the serial number of the device The Audit column will show whether that particular operation was audited whether by an internal or external auditor p 61 In the Addendum A p 62 it is possible to check all the indications appearing here MM TecnoSoft Manager 21 CFR Part 11 i File Objects Actions Tools Help User first User last name name Info 2 Info 3 Audited Added record PRO HLES PRESS URE Ided record PROFILES TEMPERATU es Added record PressureDisk P 22 Device started PressureDisk Added record MISSIONS 116 2012 6 2 Device stopped PressureDisk Device started PressureD
60. guage access the Properties tabsheet from the Options window click on Tools Options Options Properties Advanced Report Customisation Language English Temperature Mode Celsius centigrades O Fahrenheit Select the required language from the drop down list next to Language and click Ok to apply Tecnosoft s r l TS Manager 23 64 Changing the temperature measurement units Celsius Fahrenheit Only Administrator users Temperature may be displayed according to the Celsius or Fahrenheit scale Access the Properties tabsheet form the Options window click on Tools Options and select the required scale from the Temperature Mode section then click Ok to apply changes The program default is the Celsius scale Specifying the folder to which data logger missions are stored Only Administrator users You can specify the folder in which missions will be saved This data is stored in single files which are accessed by the database and these may be stored in a different folder to that where the database is stored even on a different PC as long as the specified folder resides on a PC to which all the other PC s including the database server PC can connect with read and write access Access the Advanced tabsheet from the Options window click on Tools Options and in the Mission Data Path section click on Browse and select the destination
61. hat there are no labels or stickers on the device surface Check that the drivers have been correctly installed by accessing Windows Control Panel System Hardware Device Manager if you see a warning icon next to the device name it means the drivers have not installed correctly If you change the USB port to which the interface is connected you have to reinstall the drivers The USB drivers could be conflicting with other drivers or programs on the PC When a communication error occurs try disconnecting the interface and reconnecting it to the USB port If the problem persists contact Tecnosoft technical support cannot see some of the missions If you cannot see all the missions you expect to see make sure that there are no filters enabled Remember that there could be filters applied in the Filter window but also in the Clients Instruments archive get an error after update or restore Be sure to follow procedure at p 15 64 64 TS Manager Tecnosoft s r l Tecnosoft s r l Via Luigi Galvani 4 20068 Peschiera Borromeo Milano phone 39 02 26922888 fax 39 02 26922875 e mail infoetecnosoft eu web www tecnosoft eu UNI EN ISO 9001 2008 certified for Software development 4
62. he instant the mission is programmed after which the logger will start recording This is expressed in Days Hours minutes Min and seconds Sec Rate acquisition interval expressed in Days Hours minutes Min and seconds Sec Length mission duration expressed in Days Hours minutes Min and seconds Sec Manual Start select this option if you want the logger to start manually When this option is selected and you start a logger that support this option you will have to put a clip on the logger between the two metal ends within 60 seconds the logger will check its presence every 60 seconds When the clip is removed the acquisition will start this option is not supported by all loggers and all firmware versions If you have set also a delay it will be ignored Start at type in this field the temperature at which the logger must start its recordings If the option is enabled the device will check temperature according to acquisition rate and start acquiring when that value is reached this option is not supported by all loggers and all firmware versions If you have set also a delay it will be ignored Start Time Discard this is the time expressed in Days Hours minutes Min and seconds Sec that will be discarded from the start of the mission The data is nevertheless recorded but the software will ignore them End Time Discard this is the time expressed in Days Hours minutes Min and seconds Sec that will b
63. hermore cannot access the configuration page of the program Administrator This is the highest user level and can access any program function or operation It is the first user type that must be created after which the others may follow The password should be stored in a safe place since if you are unable to login as an administrator you will not be able to carry out all the program functions Adding a user only for Administrator Advanced users To add a user select the Users archive and click on Add In the User window fill in the fields with the appropriate data fields with an asterisk are required fields Title User s title You may select one from the list or enter a new title manually in this case when you click OK to add the user the program will ask whether you would like to add this title to the list Choose Yes to add the title so that you can select it from the list for successive users or No to leave the list as it is First Name first name for this user Last Name users surname Login username used to access the program Password password required to access the program with the above username Input the password in this field after which press TAB on the keyboard or click elsewhere with the mouse The program will ask you to re enter the password if you do not input the same password you will need to re enter a new password from the beginning Level Select the appropriate level for this
64. ice 5tatus AAT A2DB5 STERILCYLIUMBO 1501001005 3 40 14 09 2011 Stopped 0 0 0 3 d himc 26 03 C 2 44 V Close Tecnosoft s r l TS Manager 41 64 Deleting a device only Administrator users You can delete a device by selecting it and clicking on Delete Changing the current use of a device only Administrator Advanced users You can change the current task assigned to a device by selecting it from the list and clicking on the Use button in the Actions menu In the Devices window change the Current Use field and then click Ok 42 64 TS Manager Tecnosoft s r l Stopping and downloading a mission Missions After having started a data logger and used it to monitor your application you may insert it into the interface and download the data for further analysis Downloading data from a device Missions Download Click the Download button to connect to the device the Mission Stop window will appear displaying some information about the connected unit You may be asked to reinsert your password if the Administrator has enabled this option p 43 Click on Next to start downloading data When you download data from a device that is currently acquiring to check the status of a device see Checking the devices in use p 40 this device will be stopped status Stopped Mission Stop Devices N T AATA2DE5 STERILCYLIUMBO 1801001005 14 03 2011 In Acquisition 0 0 0 3 d h m s
65. ill appear where you can select one of the options install the software view the manual in PDF format view the instructions for installing the USB drivers for the disk interface or update the program To install the program select the first option TS Manager and click on Install Once the installation starts follow the on screen prompts when they appear The installation program will check whether all the pre requisite components are installed If not they will be automatically installed This part of the installation may take a few minutes to complete Once all the components are installed the actual TS Manager software will install Once this is complete the only remaining step will be to create the database on the same PC since this is a standalone PC installation Creating the database SQL Server Connection type A Once the software has installed double click on the TSManager icon on the desktop or start the program from Start gt All Programs Tecnosoft TS Manager TSManager Upon the very first time the program is launched you will be asked to create the database The SQL Server Connection window will appear where one may choose the required options according to the type of installation required For a type A client server installation select the first option New Local Installation then enable the Create Database option making sure you do not change the default connection string SOL Server Connection Manual Installatio
66. irectory SterilCyl Jumbo Expiry serial 14 09 2011 1801001005 Current Use Autoclave validation Request user authentication when starting a mission Options Advanced Security only Administrator users The administrator may request that each user whenever starting a new mission reinserts their password This additional security option guarantees maximum security for the use of the system and its devices and Tecnosoft s r l TS Manager 39 64 reduces the risk of unauthorized operations To enable this option click on Tools Options access the Advanced tabsheet and click on the Require Authentication To Start Mission option Click Ok to apply the changes Options x l Propertes Advanced Database Connection String Data Source ESQLEXPRESS Integrated Security True Force database check at program start sion z Security Require Authentication To Start Mission Logout Timeout Minutes 60 H Require Authentication To Stop Mission Mission Data Path C ProgramData TecnoSoft TSManager MissionData Browse Calibration Path C ProgramData TecnoSoft TSManager Calibration Lo 40 64 TS Manager Tecnosoft s r l Checking the devices in use Devices The Devices archive shows a list of all the devices that have been connected to the database This list also displays some additional information about the particular device such as the serial number the type of data logger a
67. is an FDA 21 CFR part 11 compliant software that manages a number of Tecnosoft electronic data loggers and is therefore particularly suited for pharmaceutical processes By including this software and its compatible data loggers for temperature humidity and pressure monitoring in your processes you will be able to implement operating procedures that are fully compliant with these FDA guidelines The TS Manager system can be used in any stage of your process that involves monitoring and electronic recording of data for example in the validation of autoclave and sterilization processes in medical and pharmaceutical applications amongst others By means of this software you are able to program the data loggers by applying various logging profiles download data from the devices and analyze the recorded data after which they may be printed by means of customized reports or exported in HTML and Excel formats Main characteristics of the system This software is fully compliant with the requirements of the FDA 21 CFR Part 11 directives and also contains other specific features that facilitate the implementation of the system for particular applications The non exhaustive list below outlines some prominent features of the system to learn about all the features of the program please refer to the specific sections of this manual the data stored in the data loggers cannot be modified or edited the data stored by the software cannot be modified or
68. isk 1 0 PROFILES 17 01 temp muti 170 aan Device started PressureDisk s 17 01 201 Addedrecord MISSIONS 4 22 d em 17 01 201 Devicestated PressureDisk SN 150100205 No DEFAULT Nicolini DILINCTCTNI EN en EAT Meme Mere van nee MSS S DEAE Mm Nom bar 6 Mt 150 m THEUENELTZTRISS 10 03 21 DEFAULT Maurizio Nicolini e Meme No Noni e aur Mem eom Mo DEAUT Mae DEPALT Main o DEFALT Mmi parso NN mof DEN No No mo p DEN DENN 5 38 2 J S DEFAULT pamo Non DEFAULT Wem DEFAULT ie Neat 1 55888 SIS SISS m mb A b S b uli S 60 64 TS Manager Tecnosoft s r l Data Backup and Restore Options Backup amp Restore You may carry out a backup of the database and all the corresponding data we recommend that you carry out this operation periodically to secure a safe copy of the data to safeguard against PC failures database corruption or accidental erasures Backup only Administrator users To carry out a backup click on Tools Options and select the Backup and Hestore tab From the Backup pane select the fo
69. k on the corresponding button below the required pane to open the Field window A message will inform you of the number of fields you can add N B these fields should be specified before using the software ptions Properties Advanced Report Customization Backup amp Restore Customer Fields Instrument Fields Tanne ZUR Mission Fielda NH ele Each custom field is identified by its name For example for each instrument you may wish to specify to fields to hold the manufacturer and model click on under the nstruments pane and add Brand and then click Ok Repeat the procedure to add Model You will see that the two fields have been added to the nstruments pane From now on when the nstruments window is called up these fields will appear in the window and they will of course also appear in the Instruments list Tecnosoft s r l TS Manager 33 64 Instrument Name Autoclave ABC123 Deleting a custom field Only Administrator users To delete a custom field select it from the list and the click on the button N B It is important to note that if you delete a custom field you will not be creating space for another custom field This is because that field although deleted will still exist in stored mission data and therefore cannot be overwritten There are only 16 customizable fields in all and fields that have been created and deleted will still occupy o
70. ld like to save the file and type a name for the file By default the file name will consist of the data logger serial number and the start date and time in ISO format YYYYMMDD and HhmmSS The exported file will contain all the data that also exists in the Report Printing the data Mission Data To print a hard copy of the report open the data tabsheet and click on Print A preview window will appear from which you could then proceed to print the hard copy The user can personalize the report in three ways the top header image can be changed you may decide whether to include a copy of the graph and whether to include a copy of the data table Once the report is printed the print button will appear green and similarly in the Missions archive the Printed column will also appear green Before sending the data to the printer you can select the above options using the Print Graph and Print Table options These options are by default enabled or disabled according to the settings chosen by the Administrator p 49 Changing the header image of the report Options Report only Administrator users Click on Tools Options and open the Print tabsheet In the Logo field you will see the path to the image file You can change this file path to point to the file you require which will appear below the logo by clicking on the Browse button Alternatively you could also replace the existing file in the current folder by overw
71. lder in which you would like to save the backup file and click Execute Two files will be created in the selected folder a zip file that holds all the data 75 Data and a file that holds the a backup of the database TSManager Database Both file names also include the creation date year month and day Keep a copy of both files Restore only Administrator users To restore the data from a backup click on Tools Options and select the Backup and Restore tab From the Restore pane select the folder holding the data backup files and that holding the database backup file and click on Execute You will be asked to restart the program so that the backup set can be restored Properties Advanced Report Customization Backup amp Restore Backup path C Documents and Settings 4 Users Dati applicazioniTecnoSottil SManager Backup Execute RESTORE Database File Restoring a backup from an older version When restoring a backup created with an older version of the program be sure to updated the database by enabling the option Force database check at program start in the Advanced tab in the Options window Close and start the program again Backup in a client server installation If the database is shared on a server the backup and restore operation should be performed by the network administrator directly on the server database Tecnosoft s r l TS Manager 61 64 Running an Audit L
72. lose to save the comments automatically which can then be modified every time you reopen them e s X Mission Data lee p mm Report Graph Data Date amp Time Temperature C Pressure bar Statistics 17 01 2012 01 28 17 21 42 1 016 17 01 2012 01 29 17 21 71 1 016 From 17 01 2012 01 28 17 To 17 01 2012 03 15 17 Duration 01 47 00 N Acquisitions 108 17 01 2012 01 30 17 21 47 1 016 17 01 2012 01 31 17 21 38 1 017 17 01 2012 01 32 17 21 34 1 016 17 01 2012 01 33 17 21 44 1 017 17 01 2012 01 34 17 21 45 1 016 17 01 2012 01 35 17 21 51 1 017 Zoomed Statistics EM 17 01 2012 01 36 17 21 57 1 017 From 17012012 02 15 53 17002012 02 40 38 Duration 00 3545 1000000 Acquisitions Date amp time format dd MM yyyy HH mm ss Date 8 Time Minimum Average Date amp time Maximum Temperature 17 01 2012 01 32 17 21 34 76 68 17 01 2012 02 44 17 135 34 Pressure bar 17 01 2012 02 59 17 0 934 1 563 17 01 2012 02 26 17 3 283 17 01 2012 01 37 17 21 57 1 017 Value Date amp Time Minimum Average Date amp time Maximum 17 01 2012 01 38 17 21 61 1 017 Temperature 17 01 2012 02 47 17 113 32 131 98 17 01 2012 02 44 17 135 34 17 01 2012 01 39 17 21 63 1 017 Pressure bar 17 01 2012 02 48 17 1 063 2 730 17 01 2012 02 26 17 3 283 17 01 2012 01 40 17 21 59 1 016 17 01 2012 01 41 17 22 20 1 017 17 01 2012 01 42 17 22 12 1 019 17 04 2012 01 43 17 2233 1017 vi Test multi Profiles Export To Excel Fil
73. n Data Sourcez SQLEXPRESS Integrated Securityz True Create Database To create the database carry out the following steps Click on Test Connection to verify that SQL is correctly installed and that it is able to connect to the database via the connection string Once the test is complete the button will turn green if the test is successful or red if SQL was not installed properly or if the user does not have sufficient privileges to access the database create the database by clicking Execute If the operation is successful the button will turn green In most cases if the Test Connection was successful this operation will succeed A possible case for failure would be if the database has already been created and we are trying to recreate it however the user may not have enough privileges to delete the old database N B creating a new database Will delete all the data in the old database including the archives finally check that the database is functioning correctly by clicking on the Test Database button If the first two tests were successful this button will turn green indicating that the test was OK SOL Server Connection Manual Installation Data Source SGLEXPRESS Integrated Security T rue Create Database Connecting Using Data Source SQLEXPRESS Integrated Security T rue Executing SELECT FROM sys databases OK TestConnection Test Database Click on OK to run the program
74. n of the marker on the graph The marker can be aligned to the closest acquisition To set a marker therefore select the point on the graph and then click on one of the buttons bottom left Click on the button to the left of Start Position for the initial marker or that close to End Position for the end marker After this you can align it with a specific acquisition point forward or backwards using the lt and gt buttons that enclose the CURSOR label the area below will show the values of time temperature and pressure if present To remove a marker click on the button on the right hand side of the Start Position and End Position labels As soon as a marker is set the portion of the graph that the marker excludes is grayed out The area below the Start Position and End Position labels shows some statistical calculations in the two separate fields the date time temperature and pressure if present of the two markers are shown In the common field below you will find Time the time between the start and end markers Abs B E the temperature difference between the start and end markers Bar Abs B E If present displays the pressure difference between the start and end markers Mission Data EIER Report Graph Data Options Y me TOP MARKER u 140 00 3 5 BOTTOM MARKER Y SPAN 120 00 Start Pressure 0 000 bar 55914 80 00 Temperature C 60 00 40 00 0 5 RI GRIDLINES
75. n performing an Overkilling analysis is not possible to modify any of the above fields not even by an Administrator If you have made an error when adding the profile you will need to access the program as an Administrator delete the entry and create a new profile from scratch Deleting a profile only Administrator users To delete a profile select it from the list and click Delete N B you cannot undo this operation You will have to create a new profile if you inadvertently deleted one 30 64 TS Manager Tecnosoft s r l Managing clients and their equipment Customers This archive is especially suited for system validators that is to those users who have a number of customers and possibly more than one piece of equipment per client In this manner such users may keep track of their validation procedures knowing which devices were used for each of their client s instruments The top part of the middle pane holds the list of clients The pane below holds the instrument equipment to be validated autoclaves incubators disinfectors etc the pane enclosed in a green rectangle is the currently selected pane and that upon which the buttons will act Actions This part may also be used by normal users to keep track of their own missions possibly also setting customizable fields in the configuration section p 32 2 TecnoSoft Manager 21 C LEO X File Objects Actions Tools Help Add Delete Select All Y
76. n the program language you have selected whereas when this window appears on the first program launch it is always in English Program update When program is updated the database structure may change Be sure to updated it too by enabling the option Force database check at program start in the Advanced tab in the Options window Close and start the program again Same procedure must be followed when restoring backups from older versions 16 64 TS Manager Tecnosoft s r l Software configuration and setup After installing the program according to your preferred configuration you need to follow the instructions below to configure and use the software The following chapters describe the procedures that must be carried out for each program function from managing the archives to analyzing the acquired data Some functions are not enabled in some user privilege levels and for each function the level of user that may access the particular function will be notified We recommend that each user regardless of privilege level reads the Main Program Functions section p 20 where the main window the program structure and the basic functions are described Post installation operations Once the program is installed we recommend you follow the procedures below 1 change the program language if required To do this click on Tools Options and select the required language in the Language field Click on Ok and then close and restart the sof
77. nd the calibration expiry date TecnoSoft Manager 21 CFR Part 11 Compatib File Objects Actions Tools Help Delete Status Use Serial Calibration expiry Current use 1501002027 29 11 2012 09 13 TEST 1501002058 21 12 2012 16 23 test multi 1001002317 22 12 2012 17 43 1001002315 23 11 2012 16 47 test multi 1001002289 23 11 2012 16 47 test multi 1001002121 23 11 2012 16 47 test multi 1001002293 23 11 2012 16 47 test multi 1001002332 24 11 2012 16 45 test multi 1001002470 29 12 2012 15 48 1001002319 23 11 2012 16 47 test multi 1001002268 23 11 2012 16 47 test multi 1001002333 24 10 2012 15 09 test multi 1001002230 23 11 2012 16 44 test multi 1001002316 22 12 2012 17 47 test multi 11001002308 2102 DEFAULT Maurizio Nicolini Administrator Devices 22 12 2012 17 19 test multi 1 014 bar 7 Mt 150 m 30 01 2012 09 12 26 Checking the status of a device If you would like to check the status of a device without starting it or downloading data you can simply connect it to the interface p 34 and click on the Status button in the Actions menu The Device status window will appear where device details will be displayed amongst which the status of the device Stopped or In Acquisition Click on Close to exit the window Dev
78. ndow will appear divided into three tab sheets Report Graph and Data The Report tabsheet The Report tabsheet displays all the information related to the mission the basic information the number of acquisitions made the data logger serial number etc up to information related to the traceability of the mission which are which user started the mission the current task setting and other additional fields set by the user User Fields p 32 You can scroll through the items by using the scroll bar on the right At the end of the sheet you will see the list of measurements taken This report is in actual fact an HTML page that can be used to access the data and generate a personalized report Further on we will see how to export data p 49 Mission Data Report Graph Data 0 Below Minimum terilisation 3 Feb 2011 14 17 50 SEE ee ee ser Mr John Smith JSMITH 23 Feb 2011 14 19 38 talons ccc 00 BE AUE ser Mr John Smith JSMITH 23 Feb 2011 14 19 38 22 89 C 23 Feb 2011 14 17 50 22 59 3 Feb 2011 14 17 50 3 Feb 2011 14 19 38 esult rofile Name tarted at Started by topped at Stopped by NIN Minimum nalysis start time nalysis stop time Below Minimum ustomer ame ddress ocation Instrument alidation umber General Hospital Device terilCyl Jumbo xpiry 5 Jan 2012 14 11 45 Serial U 1801001
79. ne of these 16 positions It is therefore very important that you plan these fields in advance with a certain degree of attention before using them in the software Deleting a client only Administrator users To delete a client select it from the list and then click Delete N B this operation cannot be undone You will have to recreate a client if you make an error Deleting an instrument only Administrator users To delete an instrument select the client to which the instrument belongs and then select the instrument from the list after which click on the Delete button N B this operation cannot be undone You will have to recreate the instrument if you make an error 34 64 TS Manager Tecnosoft s r l Instruments and accessories All the data loggers that are currently compatible with TS Manager connect to the PC by means of a single USB interface called the Disklnterface This was originally developed for the PasteurDisk and SterilDisk products in both the standard version as well as the one with external probe however by means of additional custom adapters it can accept other types of loggers Furthermore the PasteurDisk Can and SterilDisk Can products do not require an adapter and can be connected directly to the interface The first operation that needs to be done is to connect the interface to a free USB port and install the drivers Connecting the Disklnterface In the TS Manager kit you will also find a USB cable the
80. oft s r l TS Manager 47 64 positioned on the closest acquisition There are also two horizontal markers in the left hand pane Options Y that are identified by Upper Limit and Lower Limit in red and blue Select whether you want to set limits for temperature or pressure in the lower pane under the CURSOR label and then click on the graph at the height where you would like to set one of the two markers Click close to UPPER LIMIT or LOWER LIMIT to set the two horizontal lines red for the upper blue for the lower or on to remove them The field under the label Y SPAN will show the difference between the two limits You can change the limits by clicking on fields that display the value and inputting the required value directly To accept the changes click on Ok or click on any other point on the window Below this you will see the ambient pressure recorded at the start of the mission via the sensor on the hardware key If the string Not Available appears it means that the mission was started before this feature was introduced Mission Data Report Graph Data Options Y 8 o TOP MARKER 124 65 140 00 35 45 70 C Y SPAN 78 94 C Start Pressure 0 000 bar 5914 Temperature C 0 5 15 00 00 15 05 00 15 10 00 15 15 00 15 20 00 15 25 00 15 30 00 15 35 00 15 40 00 15 45 00 15 50 00 15 55 00 Temporaire Total Acquisition Date amp Time From 19 11 2010 14 58 To 19
81. ogin Audit If your setup is subject to internal or external audits TS Manager is equipped with an Audit feature by which you can create a Guest user with a three day validity who is able to view the archives but cannot make any changes Database integrity test Integrity Check The auditor like any other user of the software can at any time check the integrity of the archives and missions data and check whether they have been tampered with Click Tools Integrity Check and select the archives Database and the missions Mission Data that you would like to test You may also check a given time period to be tested Time Restrictions After having selected what to test click Next to start the test procedure The program will instantly display the result indicating if applicable the archives and missions that have been tampered with Integrity Check Select Data Check Er Database Mission Data Users Stations Devices Profiles Missions Logs Fields Time Restrictions 19 03 2011 62 64 TS Manager Tecnosoft s r l Addendum A Following there is the table with all the indications appearing in the Log TYPE Description Info1 Info2 Info3 Note ENTER Program started N A N A N A EXIT Program closed N A N A N A LOGIN User Access N A N A N A LOGOUT User Log out N A N A N A START Device starte
82. ou can delete all the stations except for the station assigned to the PC from which the operation is being carried out Furthermore you can never delete the last station in the archive To access the stations archive click on the Stations button from the left menu Manager 21 CFR Part 11 e File Objects Actions Tools Help Add Delete Pr Name Address DEFAULT Missions F Stations Ir 2 1 0 2 DEFAULT Maurizio Nicolini Administrator Stations 1 012 bar 5 Mt 150 m 27 01 2012 14 57 36 This archive is never empty even right after program installation since at least one station is required and can be shared by all the PC s running TS Manager The default station is called DEFAULT and cannot be deleted unless you first create another station and associate it with the terminal you are using Adding a station Only Administrator Advanced users Click on Add to open the Station window and fill in the fields Name TECNOSOFT Address 7 Close The following fields need to be filled in those with an asterisk are compulsory Name Input a name that will be used to identify the station Address an email address linked to that terminal this information will be used by future versions of TS Manager N B It is not possible to modify any of the above fields not even by an Administrator If you have made an error when adding the station you will nee
83. r By Date Enable the Filter By Date checkbox input the start date From and the end date To of the required period and click OK to view a list of missions whose start date fall within that period Filtering missions by device type Filter By Device Enable the Filter By Device checkbox and select the required data logger type Type or the Serial Number and click on OK to view the missions matching these two parameters Filtering missions by user Filter By Start e Filter By Stop Enable the Filter By Start checkbox or the Filter By Stop checkbox to filter missions that have been started or stopped by a particular user Use the Station drop down list to choose the station on which the mission was started or stopped Use the User drop down list to select the surname of the user who started or stopped the mission Click OK to view those missions that match these settings 58 64 TS Manager Tecnosoft s r l Filtering by Profile Filter by Profile Enable the Filter by Profile option and select a filter from the drop down menu to display all the missions using that kind of profile How to show failed missions Show Failed Missions Should you have marked some missions as failed p 49 you can still see by enabling the Show Failed Missions filter Tecnosoft s r l TS Manager 59 64 Control over all the operations carried out Activity Log The FDA 21 CFR Part 11 guidelines state that a log of every action carried out as part o
84. riting it using the same name The header image file must have the following dimensions 2179 pixels wide x 348 pixels high with a resolution of 300 dpi ptions Properties Advanced Report customization Backup amp Restore Logo C PragrammikTecnasaftiTsManagenHeader jpg Include Graph Include Table Including the graph in the report hard copy Options Report only Administrator users To include or exclude the graph from the report hard copy click on Tools Options open the Heport tabsheet and enable or disable the nclude Graph option By default this option is enabled Including the table in the report hard copy Options Report only Administrator users To include or exclude the table from the report hard copy click on Tools Options open the Report tabsheet and enable or disable the nclude Table option By default this option is disabled Mark a mission as failed If for any reason you cannot download data from a started missions or a mission is for test only and you 50 64 TS Manager Tecnosoft s r l don t want to see it in the missions list any more just select it from the Missions archive and click on Failed button above It won t be shown any more since Failed mission are hidden by default Tho see them again use filters p 58 Tecnosoft s r l TS Manager 51 64 Multigraph multiple analysis of the missions Groups Along with analysing the single missions it is also possible to sel
85. section above p 13 Modifying the connection string only for Administrators If required the connection string may be modified on each PC even after the database has been created To do so you need to access TS Manager as an administrator p 19 Select Options from the Tools menu at the top and open the Advanced window In the database section locate the Connection String field and insert the new connection string To test that the client is able to connect to the database click on Test it will turn green if the connection is functioning Properties Advanced Report Customisation Backup amp Restore Database Connection String Data Sources YSGLERSPRESS Integrated Security True Test Station DEFAULT M Note with Windows 7 the default must be modified as following Data Source SQLEXPRESS Integrated Security True Recreating the database How to gain access to the SQL Server Connection window If the database has already been created and the connection to the PC has already been made there are two ways to re gain access to the SQL Server Connection window The first method only for Administrator users is by accessing the Options window click on Tools Options and click on the Advanced button in the Database area found in the Advanced tabsheet The second method may be carried out by starting the program whilst keeping the SHIFT button on your keyboard pressed The SQL Server Connection will this time appear i
86. t temp mu DEFAU Maurizio Nicolini 17 01 2 17 0172 SterilDis 100100 test mult temp mu a DEFAU Maurizio Nicolini 17 01 2 17 01 2 SterilDis 100100 test mutt temp mu is DEFAU Maurizio Nicolini 17 0172 17 0172 SterilDis 100100 temp mu 2 DEFAU Maurizio Nicolini 17 01 2 17 01 2 SterilDis 100100 test mult temp mu ms DEFAU Maurizio Nicolini 17 01 2 17 01 2 Pressur 150100 TEST Test mul m DEFAU Maurizio Nicolini 17 0172 1770172 Pressur 150100 test mul Test mul Es x DEFAU Maurizio Nicolini 17 01 72 17 0172 SterilDis 100100 ER temp mu in DEFAU Maurizio Nicolini 17 0172 17 0172 SterilDis 100100 test mult temp mu 2 DEFAU Maurizio Nicolini 1 012 bar 6 Mt 150 m 27 01 2012 16 26 01 M u mn The Mission Start window will appear that shows the list of interfaces connected to the PC the name of the panel below the interface is the serial number of the interface itself as well as an image of the data logger that has been inserted along with some additional information the type of data logger unique serial number that cannot be modified e
87. ted in ascending alphabetical order and an up arrow will appear close to the column name If you click the title again the arrow will change to a down arrow and the list will be sorted in descending order This makes it simple to locate the items you are looking for File Objects Actions Tools Help Add Delete Status AES Ly Alberto Enabled Guest 16 01 2020 05 45 Missions Enabled Advanced 16 01 2020 05 42 a Administrator 27 01 2020 14 33 Noon 16 1 21200542 ati en 16 01 2020 05 44 we im Stations I 2102 DEFAULT Maurizio Nicolini Administrator Users 1 013 bar 4 Mt 4 150 m 27 01 2012 14 37 51 Editing and deleting entries In TS Manager it is not possible to modify parts of an entry to maintain conformance with the requirements of 21 Part 11 since these may have been already tied to some program operations such as starting a new mission The administrator user however may delete an entry and create new ones for example if an error was made when typing in some details In any case the entry that has been deleted and the operations that were linked to such entries will remain traceable 22 64 TS Manager Tecnosoft s r l Timeout re type password To avoid the possibility that a third person uses TS Manager in the name of another user for example if the legitimate user leaves the software running and moves away from th
88. tication to launch a mission has been enabled you will have to re type your password to proceed p 38 TecnoSoft Manager 21 CFR Part 11 Compati File Objects Actions Tools Help Start Download Filter Toggle Filter Failed Print Preview Group gt j i 27 Profile User User Started Stopped Device Serial Use Sealed Printed Custome Instrume N Protoc Station first last name name ESA Missions 167 0172 16 0172 Pressur 150100 TEST PRESS u DEFAU Maurizio Nicolini 16 0172 Pressur 150100 TEST PRESS DEFAU Maurizio Nicolini 17 01 2 17 0172 StenilDis 100100 test mult temp mu RS DEFAU Maurizio Nicolini 17 01 2 17 0172 StenilDis 100100 test mult temp mu DEFAU Maurizio Nicolini 17 0172 17 01 2 SterilDis 100100 test mutt temp mu 2 DEFAU Maurizio Nicolini 17 01 2 17 0172 SterlDis 100100 test mult temp mu ES DEFAU Maurizio Nicolini 17 01 2 17 01 72 SterilDis 100100 test mult temp mu DEFAU Maurizio Nicolini 17 0172 17 01 2 SterlDis 100100 test mutt temp mu a s DEFAU Maurizio Nicolini 17 01 2 17 0172 StenilDis 100100 test mul
89. tion key To be able to run TS Manager you will need the USB protection key supplied with the software and insert it in a USB slot on the machine This must be plugged in starting from the moment the program is started The key does not require any drivers and also contains a code that may in the future be requested by Tecnosoft in order to activate additional software modules or new program features and updates Furthermore the key also contains a temperature sensor and a barometer whose readings are displayed and updated in real time in the main window of the program p 20 Client server installation standalone PC type A TS MANAGER DATABASE CLIENT SERVER After starting your PC place the installation CD in your CD ROM drive the program should run automatically 12 64 TS Manager Tecnosoft s r l if it doesn t click on Start Run and type D setup exe your CD drive may have a different letter assigned to it replace D with the appropriate drive letter Select the language to be used for the installation and click on Install The language selection refers to the language that will be used in the installation windows and is not the language that will be used for the main program TS Manager is always installed with all the languages available at the time of installation and you may select the appropriate language from the configuration window of the program A window w
90. tus e ez Missions li Groups Devices Profiles Stations I gt 2 1 0 2 DEFAULT Maurizio Nicolini Administrator Users 1 013 bar 4 Mt 150 m 27 01 2012 14 31 04 In the User window that appears fill in the fields as required User s title You may select one from the list or enter a new title manually 18 64 TS Manager Tecnosoft s r l A First Name users first name Last Name users surname A Login username used to access the program along with the password Password password to be used to access the program Input the password in this field after which press TAB on the keyboard or click elsewhere with the mouse The program will ask you to re enter the password if you do not input the same password you will need to re enter a new password from the beginning N B take note of the administrator password and store it in a safe place If you forget this password you will not be able to access the program as an administrator and will therefore not be able to use all the program features It is impossible to retrieve the password once this is lost not even by Tecnosoft Level select Administrator N B If you select a different level of user and close the program on the successive login you will no longer be able to access the software as an administrator and therefore you will not be able to create another user with Administrator privileges and therefore you
91. tware to apply the change create an administrator user p 17 this is a required operation if an administrator user is not created you might not be able to access some program functions log in to the software as the newly created administrator p 19 create the various users that will need to access the system p 24 create the Stations PC s that may act upon the common database create the Profiles and Customers archives m a Post configuration operations Once you have configured the program and created the archives you require the archives may also be accessed and created at a later stage you are finally in a position to use the software and its basic functions that is starting a data logger downloading and analyzing the data The main operations that need to be carried out are 1 connecting to a device and starting a data logging mission 2 once the mission is complete connecting to the device and downloading data 3 analyzing the data according to the selected profiles and printing or exporting the data Tecnosoft s r l TS Manager 17 64 Running the program for the first time Once you have installed the program on the computer or computers in your setup and after creating the database and having connected all the machines running TS Manager software to the database you may proceed to create the database tables This operation can be carried out by any user on any PC however after the first access when th
92. wo or more missions When selection is complete click on Group in the action toolbar to open the Aad Mission Group window Cancel Mew Group Cancel NewGroup Select the group where you want to add missions and click on OK or if a group is not available click New Group to open the Group window p 51 At the end the multi graph window will immediately open p 52 Remove a mission from a group To remove a mission from a group select the Groups archive select the desired group and click on Group above Select the mission to be removed identified by the type of logger serial number and starting date amp time and click on Remove Multigraph analysis To open a group of missions and make an analysis double click on it from the Groups archive Above there is the area with the graph below the tabs with data and statistics and other information Tecnosoft s r l TS Manager 53 64 Missions group LENT o p 5 5 o Hi 01 30 00 02 00 00 02 30 00 03 00 00 03 30 00 General Statistics Markers Curves Data 8 analysis Name Multigraph F Show legend Mode Single process time synchronization Reset zoom Notes Customer Instrument 4M Change graph area size It is possible to change proportions between the area of the graphs and the tabs by placing the cursor on the limit line between the two areas see the grey colour of the tab area and keep pressed th
93. xpiry date for the device calibration device status Stopped if it is not acquiring n Acquisition if a mission is in progress acquisition interval expressed in days hours and minutes if the device is Stopped this value refers to the interval used in the preceding mission the current temperature being measured Tecnosoft s r l TS Manager 37 64 the current pressure being measured of available battery voltage in the example below we see a connection with a SterilCyl Jumbo device Click on Next to select the profile Mission Start Devices AATA2D80 STERILCYLJUMBO 1801001005 3 91 14 09 2011 Stopped 0 0 0 0 d h m s 25 94 2 44 V Close From the Devices tabsheet we move on to the Profiles sheet still within the Mission Start window From the drop down list at the top left of the form select the name of the profile you wish to use for this mission only those profiles created for that particular logger will be displayed this has been selected from the Type field when adding profiles p 28 You cannot modify the parameters for the selected profile not even those shown in the bottom right part of the form for the type of analysis selected You can however select a different start delay when preparing the profile you could only specify a delay in terms of days hours minutes and seconds however when starting a new mission you can instruct the logging to start at a specific date

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