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XpertVal - FLW of PA, Inc

1. Intervals By Time By Value Intervals By Time By Value Intervals By Time By Value v Enable Value Triggered Start Of Data Collection v Enable Value Triggered Start Of Data Collection v Enable Value Triggered Start Of Data Collection v Reset even if Data Collection Already Started v Reset even if Data Collection Already Started v Reset even if Data Collection Already Started Curent v Vale wi chem w D wv lt 1000 Curent w Value v ofChannel w D v lt vioo Curent 4 Value Ni of Channel w o ee w 1000 8 Any 3 All Value Avg i Avg 2 vk Triggered Data Reset v Enable Value Triggered Data Reset Iv Enable Value Triggered Data Reset 12 13 Reset Only on Return Pass Through the Value Reset Only on Return Pass Through the Value _ Reset Only on Retum Pass Through the Value 14 Current v Value v of Channel vl 0 M lt v 100 0 Current v Value v _of Channel vl 0 M lt v 100 0 Current v Value v of Channel v 15 Enable Value Triggered Test Duration v lt v 1000 Current v Value v of Channel v lt gt v Enable Value Triggered Test Duration v 0 v lt 100 0 Current v Value I of Channel Cales NNNM lt Enable Value Triggered Test Duration Curent Y Value v of Channel E 0 S lt w 1000
2. After calibration started the software will first check the drift when the drift is within the specifications the software will start thermocouple calibration lave XWalFL 1 0 0 6 No login Administrator Calib Calibration autoc Actions 2 Calib at 90 Ch Func Assign Label Status Cur Value Cur ERR Avg ERR Max ERR 00 10 Ydc Press Disabled G Gen v 01 Te T penetr drain ok 89 57 0 04 0 047 0 05 e 1 17 RTD 689 711 C Drift 0 01 C 0 05 l 1 00 E D Iv 02 Te T penetr ok 89 68 0 07 0 117 0 14 V 03 Te T penetr OK 89 72 0 11 0 157 0 18 amp Input Module V 04 Te T penetr OK 89 63 0 02 0 060 0 08 All Assigned V 05 Te T penetr OK 89 87 0 26 0 307 0 33 V 06 Te T penetr ok 89 72 0 11 0 157 0 18 v 07 Te T penetr OK 89 72 0 11 0 163 0 20 V 08 Te T penetr Ok 89 89 0 28 0 317 0 34 v 09 Te T penetr OK 89 74 0 13 0 180 0 21 v 10 Te T penetr OK 89 74 0 13 0 183 0 21 a 11 Te T distrib OK 89 72 0 11 0 163 0 20 MIZ 12 Te T distrib Ok 89 70 0 09 0 143 0 18 zw 13 Tc T distrib ok 89 70 0 09 0 143 0 18 Once the first step was accomplished the software will les ret ox T n ozio vn SE 15 Te T distrib OK 89 70 0 09 0 130 0 16 t ti ll It h th bl k t t t t v 16 To T distrib Ok 89 76 0 15 0 197 0 23 automatically Sw te DIOCK to Next Set poin dm a SE a Rm n d GE RI 18 Te T distrib OK 89 63 0 02 0 057 0 08 MIZ 19 Te T distrib OK 89 55 0 06 0 027 0 06 z
3. any channel ofall assigned as ofall set as above or below a temperature defined by the user tz Test Config Intervals By Time By Value Cales Ze Test Config Intervals By Time By Value SC 46 tz Test Config Intervals By Time By Value v Enable Value Triggered Start Of Data Collection v Enable Value Triggered Start Of Data Collection v Enable Value Triggered Start Of Data Collection v Reset even if Data Collection Already Started v Reset even if Data Collection Already Started v Reset even if Data Collection Already Started Any v Value Iv of All Assigned as v Pes vw lt v 100 0 Any I Value M of All Assigned as y Press M B v 100 0 Any M Value vw of All Assigned as v Press P lt v 100 0 Value of All Assigned as Press F Value of All Set as penetr Value Avg distrib v Enable Value Triggered Data Reset v Enable Value Triggered Data Reset wv Enable Value Triggered Data Reset Reset Only on Return Pass Through the Value Reset Only on Return Pass Through the Value Reset Only on Return Pass Through the Value Curent M Value wi of Channel v D vi lt w 1000 E C
4. Click on Save to save the verified configuration 20 Equipment i ag Options Use External Probe LIVES block control if available E Audit Trail User s Manual rev2 0 May 2005 XpertVal Reference Probe for Calibration Different types of reference probes can be used for calibration Lives Reference probe internal or external Smart probe Hart probe or Ametek DTI 1000 The new concept introduced by XpertVal is the temperature block controlled by the reference probe when using Lives probe The minimum requirements for this option is to use the reference block Lives ATC B Series This type of block has an external input for the Lives reference probe so this probe could be configured to control the block that means the regulations of the temperature block will be controlled by the external probe Prior to this is needed to enable the option Use external probe Lives block control if available in Admin module and then choose Lives External probe in the Equipment Configuration Reference probe d Administration E Les Members N ff Admins Style Windows XP v Users E f Reporters 0 68 Reviewers B EJ Database _ Always Lock Front Panel in Test Cl Saturation Table Scan Interval Fixed to 2 CG Auto Name Format be Template Test Calib Report i Veri Equipment m D User s Manual _ r
5. Halk Company Ok v Launch the program Database not selected Click on Finish to start the software enter the name and the serial number XpertVal icon is automatically placed on the desktop Warning this is a case sensitive window enter the name and the serial number as written on the CD s label Uninstall XpertVal Insert the installation CD and double click on Setup exe follow the instructions displayed step by step j XpertLog InstallShield Wizard i XpertLog InstallShield Wizard Program Maintenance Welcome to the InstallShield Wizard for XpertLog Modify repair or remove the program C Modify ne Change which program Features are installed This option displays the The InstallShield R Wizard will allow you to modify repair or remove XpertLog To continue click Next Custom Selection dialog in which you can change the way Features are installed C Repair Repair installation errors in the program This option Fixes missing or corrupt files shortcuts and registry entries al Remove XpertLog from your computer InstallShield lt Back Cancel Z XpertLog InstallShield Wizard iy XpertLog InstallShield Wizard Remove the Program InstallShield Wizard Completed You have chosen to remove the program From your system Click Remove to remove XpertLog from your computer After removal this program will no l
6. Chan Config 0 10 Vdc HD HU i BD HU shunt Resistor shunt Resistor Range IP Range np Min Ing Max Wot Min Wut Mas M Val i M Val 00000x vw B val B val Enter the label of each channel by double clicking on label corresponding to each channel User can also assign specific name for each channel or group of channels by right clicking on the channel then Assign Assignment x penetratiorl Los Gei mI User s Manual _ rev2 0 May 2005 XpertVal The example below will use a 20 channels module and a extra pressure channel 0 10 Vdc for a 0 5 bar absolute pressure transducer first 10 channels will be used for penetration study and last 10 channels will be used for distribution X alFL 1 0 0 6 No login Administrator Template Config Actions Mew template e M Ch Func Assignment Label Cal Allowed Input Output M val Configuration F Config Steam Saturation Calib Config Virtual Chann Add Info Input Z Input Module All Assigned 25 User s Manual _ rev2 0 May 2005 XpertVal Template F Configuration Define the type of study distribution or penetration Click on F Config right click in the window and select all or only the channels to be used for penetration f s F Value Cono Je Chan List Config ok F chn Func Assign d Lj Ge F Yalue Config Chan List Canfig e On TET em Kn Te
7. If the user does not activate this function the data logger s front panel will be locked only during the thermocouple calibration The data logger will be unlocked at the end of the calibration If the function is active the locking of the front panel will be active during the thermocouple calibration and the data acquisition during the test When the lock function is active the front panel keyboard of Hydra data logger does not responds to any external actions during the thermocouples calibration or during the test Manual stops or the modifications of the data logger configuration are forbidden to the users during the data logger function in this configuration The lock function is automatically disabled at the end of thermocouple calibration and or at the end of the test In this configuration keyboard locked if you exit from the software with the option Terminate and Continue Hydra Scan without PC or Terminate and do not change current status of Hydra the data logger will continue to record the data and the front data logger s keyboard will stay locked In order to disable the front panel lock you need to connect the computer to the data logger Click on Equipment module Disable the option lock front panel and then click on Verify 19 User s Manual _ rev2 0 May 2005 XpertVal Equipment Connections Verification After the configuration 1s done click on Verify A dialog
8. Drift allowed drift allowed for the reference probe during check time for drift Dev From reference allowed drift will be checked starting the moment when the measured temperature by the reference is within Set point deviation allowed Check time for drift drift will be verified for the time interval defined here i cx E 3 Calibration EE dii at 90 RTD amp Block iy at 130 El Verification Drift Allowed C 0 05 at 100 iy at 121 ot ENSE Dev From Refer Allowed C 2 0 Check Time For Drift rnm ss 3 00 lt gt Ta User s Manual _ rev2 0 May 2005 XpertVal 3 2 4 Setup F Value Configuration The module F Config will configure the calculation of the F value in the function of the test type steam dry heat with or without depyrogenetion The instantaneous lethal rate F value of a given steam sterilization cycle is the lethality at specified conditions and can be calculated once the D value and Z value are known using the following equation F 105 Z Where To Temperature within the item being heated T Reference temperature Z Z value of the challenge organism For steam sterilization the values typically used are T 121 1 C and Z 10 C When these values are used the F value is defined as the F value The above equation is an exponential function and therefore as To increases there is an exponential increase in Fo Note that for Fo the inst
9. New Yerification Input Verification Name Verification autoclave rea x 2 J verification successfully completed User s Manual _ rev2 0 May 2005 Double click to open verification report XValFL 1 0 0 6 No login Administrator Verification Actions Save Report As Page 1 of 1 Verification Report 6502753 D338 4129 B8 3 007 BE76D1265 Printed 12 06 2005 18 40 57 from Cal D pt Ar Verification Template Verification autoclave Template for autoclave XValFL 1 0 0 6 SN 26674 01036 79003 10562 Licensed to Evaluation Hydra Id 63573021 Module Id 1 Hydra Interval 0 10 hh mm ss Scan Rate SLOW Block LIVES 3125 ATC 157B SN 524435 00141 Ext Control Probe LIVES Ext SN 52915403 Verify at 121 Temp 121 0 C Error Allowed 0 2 4 C Check Time 1 00 mm ss RTD Drift Allowed 0 10 4 C Dev From Refer Allowed 2 0 C Check Time For Drift 1 00 mm ss Action Date amp Time Probe 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 Funo Kater 0 10 Wc Te T Te T Te T T T Te T Te T Te T Te T Te T STI TeT TI Te T Te T Te T TeT TeT ToT TeT ToT Set As N A Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Used Calib Add Info Calibration autoclave a
10. o LIVES Intemation gt XpertVal USER S GUIDE Revision 2 0 May 2005 LIVES International User s Manual _ rev2 0 May 2005 IN Introduction 1 1 Introduction 1 2 Concept 1 3 Advantages XpertVal Equipment 2 1 Hardware equipment 2 2 Minimal Configuration of XpertVal Validation System 2 3 XpertVal Hardware Connections 2 4 Hardware configuration XpertVal Software 3 1 Software installation and starting 3 2 4 Install XpertVal Uninstall XpertVal Start XpertVal Main Menu S Setup Equipment Equipment Configuration Available System Equipment Configuration Front panel lock Equipment Connections Verification Reference Probe for Calibration 3 2 25 Setup Administration 3 4 3 Setup Thermocouples Calibration and Verification Configuration Thermocouples calibration Calibration Verification Configuration 3 2 4 Setup F Value Configuration 3 2 5 Action Equipment Info 3 2 6 Action Template Template F Configuration Template steam saturation Template calibration and verification configuration Template virtual channels Template add info Template view report S Action Calibration Pre Calibration Principle of calibration Performing the calibration 3 2 8 Action Verification Post Calibration S249 Action Test Test configuration Delayed Start Reset or Stop data acquisition By Time By Value Enable Start based on Temperature Value Enable Reset
11. Upload Config From Hydra And Continue Test reports available for the report by default the last one is highlighted choose one and click Ok FJ Calibration autoclave 12 06 05 17 31 15 Ze XValFL 1 0 0 6 No login Administrator Test The configuration screen will appear st e Double check the configuration by default the configuration J2 as described in the template used for calibration will be used E Actions 2 2 F Value configuration gen Reset Test F Corffi F alue Configuration Steam Z Value 10 0 C To Temp 121 0 C Min Temp To Calc F value 118 0 C x x xi lt i lt i ki x XI XI XI XI TIR Saturation configuration TI Steam Saturation Temp Chan 01 Press Chan 00 Pressure Unit bar ia Tolerance 0 05 Saturatign Config Test E Virtual Chan Add Info Actions Test configuration Start Test Reset Test F Config Saturation Config Test Configuration Scan Interval h mm ss 0 08 Save To Database Yes Save To Hydra MC Yes Fast Hydra Scan Rate No Start Data Collection Conditions Not Set Data Collection will start Immediately Reset Data Conditions Not Set Stop Test Conditions Not Set 42 as User s Manual _ rev2 0 May 2005 XpertVal Virtual channel configuration GC i Start Test irtual Chann Config Maxval max 01 20 Min val min 10 20 Delta max 01 20 minf
12. device c windows system csmapper sys device c windows system carddrv exe slot n Replace n with the number of PCMCIA slot number available on your computer Verify that the location of the files Csmapper sys and Carddrv exe is in Windows System Save modifications and restart the computer zd User s Manual _ rev2 0 May 2005 3 XpertVal Software 3 1 Software installation and starting Install XpertVal Warning XpertVal Before installing XpertVal software disable screen savers of the computer and the stop of the hard disk during normal operation of the PC Insert installation CD in the computer and double click on Setup exe After the Setup Box follow the instructions displayed on the screen for choosing the directory in which XpertVal will be installed iz XpertLog InstallShield Wizard Welcome to the InstallShield Wizard for XpertLog The InstallShield R Wizard will install XpertLog on your computer To continue click Next WARNING This program is protected by copyright law and international treaties i XpertLog InstallShield Wizard Destination Folder Click Next to install to this folder or click Change to install to a different Folder A Install XpertLog to C Program Files Lives International pertLogl Change InstallShield i Cancel zs ji XpertLog InstallShield Wizard License Agreement Please read the F
13. lt Enable Time Triggered Data Reset Reset Time Today S hh 18 S mm 44 S End Time Today v hhi 18 mm 44 Automatic start of data acquisition data acquisition will start at a moment defined by the user Automatic reset of data acquisition data acquisition will be reset at a certain moment defined by the user Automatic stop of data acquisition data acquisition will stop at a moment defined by the user An error message appears if the time interval is not defined correctly xvalrt 1 0 0 6 x e Start Time in the past 45 User s Manual _ rev2 0 May 2005 XpertVal By Value Enable Start based on Temperature Value Principle of operation In order to Start Reset or Stop the test based on the temperature or F Value it 1s necessary to program the conditions to be satisfied for performing this operations First define the type Value or First or All or Average Then define the channel or group of channels Then define the assignment or set as for this group of channels Then define the condition above or below Then define the value of the temperature of F Value Data acquisition can be programmed based on value of above or below a temperature defined by the user F value value avg current channel any assigned as any set as Ze Test Config ta Test Config ta Test Config
14. mae Password e password when enabled by the administrator Member must change password at next logon 23 User s Manual _ rev2 0 May 2005 XpertVal Database Enable the option Login required to use this database in order to avoid usage of the data base with no login Allow to select database on startup will allow user to choose from different data bases available Backup database at app Exit will create a backup copy of the data base when closing the application Administration Equipment Options Location C Xlog_0 6 delta dx C Members ID t DSFSF3F F955 4CD3 9C72 1034E DE FOD 4D Admins i i Users Login Required to use this Database Reporters Allow to select database on startup Reviewers Create New DB S c Auto Name Format Backup Database at App Exit Test _ Compact Database at App Exit Calib Compact Database Now Report erif Audit Trail Audit trail enabled need to be enabled in order to generate the Audit trail report Administration J Options EB eg Members dos Admins Browse for Audit Database Audit Trail Enabled Show Audit Report be Users be Reporters TN Reviewers Click on Show Audit Report in order to display the audit trail report the audit trail report has the ability to filter the events for fulfill with administrator audit trail management Click on the right hand arrow in order to select or unselect all
15. s Manual _ rev2 0 May 2005 XpertVal System Equipment Configuration Click on the Equipment module in order to configure the system s equipment The data logger The temperature standard The temperature block Verification of connection s between the computer and the system s equipment Equipment configuration Lack front L iet Mode Comm Port v Fort 1 vi Port 1 i Baud 36400 vi Baud 9BD m LU rit Celsius K Type LIVES Ext MB IQ ATO Digits HART D TI 51 LIVES Int LIVES Ex Module 1 Data Logger Temperature Reference Temperature block Lock front panel option Define Define Define Communication mode Communication mode Communication port Communication speed baud rate Module number up to 10 0 9 XpertVal remembers each module calibration Communication port Communication speed baud rate Temperature standard used IRTD Hart Jofra Lives internal probe control Lives external probe control 18 Communication port Communication speed baud rate Temperature block used Lives Hart User s Manual _ rev2 0 May 2005 XpertVal Front panel lock In the data logger configuration there 1s a function called lock front panel
16. 1 00000 Stop the test click on right upper corner XValFL 1 0 0 6 No login Administrator Test New Test Choose the first option to terminate test Terminate and stop Hydra The logger and the software will stop collecting data and the report will appear in the test list F z Test Termination L r Lock Front Kanel Shtern Terminator 52 User s Manual _ rev2 0 May 2005 XpertVal There are three ways of stopping the test Stop the software and the data logger acquisition simultaneously Click on Cancel and choose the Terminate and Stop Hydra option jis Test Termination Oo x Terminate and Stop Hydra 2 Terminate and Continue Hydra Scan without PC O Terminate and do NOT change current status of Hydra C Lock Front Panel After Termination Stop the software and do not stop data logger acquisition user may change data acquisition interval Click on Cancel and choose the Terminate and Continue Hydra Scan without PC option Test Termination 15 x IH Test Termination Jg x 2 Terminate and Stop Hydra Terminate and Continue Hydra Scan without PC Cancel 2 Terminate and do NOT change current status of Hydra Lock Front Panel After Termination Hydra interval hh mm ss 0 10 Test Time Capacity of MC 05 00 hh mm The user can modify the interval of data acquisition by u
17. 12 Kg
18. Calib Status OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK ht Val H 1 00842 1 00643 1 00628 1 00896 1 00440 1 00655 1 00650 1 00493 1 00626 1 00432 1 00308 1 00418 1 00396 1 00413 1 00413 1 00369 1 00449 1 00535 1 00930 1 00345 Filter 2 B val An 070 073 087 070 075 076 Am 075 058 0 44 053 050 058 051 054 060 053 A n 051 Label drain Rebuild Repot H Vert at 121 12 06 05 18 33 38 120 501 0 02 0 01 0 02 0 00 0 02 0 01 0 02 0 01 0 01 0 00 0 03 0 00 0 00 0 01 0 02 0 00 0 00 0 00 0 00 0 02 F 01 M 120605 18 33 47 120 498 0 02 001 0 00 0 00 0 00 0 01 001 0 01 001 000 00 0 00 000 001 00 0 00 0 00 0 00 000 002 12 06 05 18 33 55 120 497 0 04 0 01 0 02 0 02 0 00 0 01 0 01 0 03 0 03 0 02 0 01 0 02 0 00 0 02 0 01 0 02 0 02 0 00 0 02 0 02 FV 02 12 06 05 4120 48 S 0 06 0 03 0 02 004 0 02 0 03 0 03 0 03 0 05 0 02 0 01 0 02 0 02 0 03 0 03 004 0 02 0 02 0 04 0 04 F 12 06 05 4120 503 0 08 003 0 04 0 06 003 0 05 0 05 0 05 0 07 0 04 0 05 0 05 0 04 0 05 003 0 04 O06 0 05 O06 0 04 03 12 06 05 120 508 0 15 D 11 0 11 0 14 011 0 13 0 13 0 11 0 14 DI 0 11 0 13 0 12 0 13 0 11 0 12 0 12 0 13 0 14 0 12 V 04 12 06 05 18 34 27 120 520 0 07 D 04 0 03 0 05 0 03 004 004 0 06 0 04 0 01 0 02 0 03 0 03 004 0 02 0 03 0 05 0 03 0 03 0 03 F 120605 18 34 35 120 531 0 08 0 04 0 05 0 07 0 04 0 04 0 04 0 06 O06 O03 004 0 06 0 03 0 04 0 02 0 05 0 07 003 OOF 0 05 05 lv 06 Mn 120 497 0 02 0
19. Page 1 2 mm li ee dh em mm Save print or send to excel file using the task bar above the report The reports can be saved as report file Report file frp EI _ Report file TT trp text file ASCII Text file txt HTML file Rich Text file rtf J HTML file htm csv file CSV File csv BMP file bmp bmp file d Excel Document excel Adobe Acrobat Document pd pdf file Error messages Three types of error messages may appear during a calibration Err L Err H OTC orP OLorN OL The Err L or Err H messages means the error is lower L or higher H than the accepted error defined by the user Possible causes The thermocouple is not inserted enough in the well The thermocouple wire is not a good quality wire and can not support the specifications defined by the user OTC error means open thermocouple This error will appear when The thermocouple wire is cut The thermocouple is not connected to the data logger The thermocouple is oxidized above the limits 39 User s Manual _ rev2 0 May 2005 3 2 8 Action Verification Post Calibration After either one or a succession of tests the user is asked to verify that the thermocouples used are still within the XpertVal specifications defined by the user at the beginning of the test This operation is called Verification or Post calibration In Verification click on New to start a Verification
20. Sorin Haias sorin Sorin Haias sorin Stop Test Start Test Sorin Haias sorin Sorin Haias sorin Stop Test Start Test Stop Test Start Test Stop Test Start Test Stop Test Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin MT Be e Auto name format Only start test option activated XLog 1 0 0 6 sorin Administrator Audit Actions Close Report View Filter Rebuild Report Ls J Audit OFF Audit ON Audit Warning Battery Warning CRC ERROR Calib Deleted Calib Warning Compact Database Download Logger Import Test Logon Logon Failure Manage Members Option Changed Report Created Report Deleted Report Reviewed Reset Test Setup Loggers Start Data Collection Stop Calib Verif Stop Data Collection Stop Test Take Ownership Template Reviewed Test Deleted Test FConf Chang Verif Deleted nnnnnnnngnnnnnnnnnnnnnnnnnnnni Audit report Ever ts shown Start Test Audit DB created Date Time 21 05 05 19 11 39 23 05 05 11 07 08 23 05 05 12 38 51 23 05 05 18 19 38 23 05 05 19 39 46 23 05 05 19 41 34 23 05 05 19 47 11 23 05 05 19 48 42 23 05 05 19 49 36 23 05 05 20 47 57 23 05 05 21 02 08 23 05 05 21 04 18 23 05 05 23 28 05 23 05 05 23 51 58 24 05 05 01 06 59 24 05 05 01 24 55 24 05 05 01 37 12 24 05 05 01 38 32 24 05 05 01 40 19
21. appears then press the K Comm button The display will briefly indicate Serial then bAud and the display the current baud rate e Use the Up or Down arrows to increase or decrease the baud rate then press Enter The nest parameter in the Comm menu the serial sample period will then appear Start a new HyperTerminal session Comm 1 Bauds 9600 Data 8 Parity None Stop bit 1 Flow control none then File Properties Parameters ASCII configuration check the 2 upper boxes in the window send EOF and locally write the characters e Enter the request SN in order to display on the computer s screen the serial number of the module e Check the serial number displayed on the screen with the serial number physically labeled on the module If the serial number displayed 1s only the last three digits or it doesn t corresponds with the serial number physically labeled on the module then it has to be changed Enter the following command in order to access the serial number modification PA 2051 Enter the serial number of the module SN xxxxxx Enter the command SN to display the serial number check if the serial number displayed is correct Enter the command PA 0 to lock the calibration menu V Programming the PCMCIA communication card Insert the PCMCIA communication card in the PCMCIA computer s slot Follow Windows instructions for installing the card use the driver provid
22. based on Temperature or F Value Stop Test based on Temperature or F Value Start Test Stop the software and the data logger acquisition simultaneously XpertVal ve JI A A ANBAR ha QO 13 13 14 15 16 17 17 18 19 20 21 22 26 26 27 28 30 3l 33 33 33 34 34 35 36 36 36 40 42 43 45 45 46 46 48 48 49 53 Stop the software and do not stop data logger acquisition user may change data acquisition interval 53 Stop the software and do not stop data logger acquisition user cannot change data acquisition interval Test Report Data Logger used as stand alone unit data acquisition without computer Read data from the PCMCIA card XpertVal Technical Specifications 4 1 XpertVal Thermal Validation System Uncertainty 4 2 Data Logger Hydra 53 54 57 58 60 60 61 User s Manual _ rev2 0 May 2005 4 3 Temperature standard 4 4 Temperature block XpertVal 62 63 User s Manual _ rev2 0 May 2005 XpertVal I Introduction I 1 Introduction XpertVal is a stand alone thermal validation system that simplifies the entire validation process by significantly reducing setup minimizing sensor handling and presenting critical study data in easily customized report formats This advanced system is specifically designed to conform with new FDA electronic records guidelines 21 CFR Part 11 and meet international and European norms for validation of pharmaceutical biotechnology and medical
23. device EN 285 EN 554 manufacturing plants XpertVal is a portable system intended to be used throughout the facility on a routine basis Although Lives International specifies an operating environment of 0 to 50 C and a relative humidity of lt 95 non condensing as well as a nominal supply voltage of 115 230 VAC these environmental specifications will not be verified in this document because the instrument will not be permanently installed in a single location Continuous evolution of the pharmaceutical biotechnology medical equipment market and international regulations request more reliability and best performance of the Thermal Validation Systems The complex equipment controlled by the computer has the ability to help the final user to improve his validations of thermal process Validation of software IQ amp OQ training the user 21 CFR part 11 compliant prompt and high quality Service After sales are few of the methods applied by LIVES International to allow XpertVal users to obtain the highest degree of comfort and confidence XpertVal thermal validation system XpertVal System saves time and offer safety features by hands free thermocouple calibration before and after the test quick training user friendly automatic reports generation calibration test post calibration real time trending Statistics after the test 21 CFR Part 11 etc Raw data is encrypted and double protected on a PCMCI
24. display Technical specifications Resistance Temperature range Material Hysteresis Accuracy Dimensions Model Reference probe Temperature range Resistance range Probe Parameters Accuracy Temperature coefficient Temperature resolution Resistance resolution Calibration Display Dimensions Weight Type SOFTWARE 100 ohm nominal 0 1 ohm a 0 C 200 a 500 C inconel lt 0 01 C 09C with extremely points 183 et 420 C 0 018 C 196 C 0 018 C 0 C 0 019 C 200 C 0 023 C 420 C Type 5612 0 187 dia x9 0 475 x 22 86 cm Type 5613 0 187 dia x6 0 475 x 15 24 cm Type 5614 0 225 dia x I2 0 635 x 30 48 cm HART 200 650 C 0 to 400 ohm 25 or 100 ohm ITTS 90 IPTS 68 or Calendar Van Dusen 0 006 C 0 C 0 009 C 100 C 0 012 C 200 C 0 018 C 400 C 0 024 C 600 C lt 0 5 ppm C 0 001 C 0 0001 ohm The coefficients are corrected in the equipment during the annual calibration The formulas for ITS 90 are stored in the thermometer s firmware The display shows the real temperature 8 digit 7 segments LED 14 3 x 18 1 x 6 1 cm 1 Kg HART The RTD Thermo software of LIVES International allowes Display up to 9 reference probes in the same time HART probe or intelligent probe IRTD Trace the report under EXCEL with the continuousl
25. distrib 14 Tc T distrib 15 Te T distrib 16 TET distrib 17 Te T distrib 18 Tc T distrib 19 Tc T distrib 20 Te T distrib Status Disabled Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value e XValFL 1 0 0 6 No login Administrator Verification Actions Input A Input All Assi Start Verif Verif Corfig Verification Not Started 1 15 i Ch Func Assign Label Status oo 0 10 vdc Press Disabled v 1 d ch penetr drain value Yerification Configuration Value Value verify valle at 121 Temp 121 0 C Error Allowed 0 2 C Check Time 1 00 mm ss RTD value Drift Allowed 0 10 C Dev From Refer Allowed 2 0 C Check Time For Drift 1 00 mm ss Value Value wi 08 Tert penetr Value v 09 Tc T penetr Value M 10 Tc T penetr Value v 11 TE distrib Value V 12 TET distrib Value V 13 TET distrib Value v 14 Test distrib Value v 15 Tey distrib Value v 16 Tel distrib Value vV 17 sy distrib Value IV 18 Teil distrib Value IV 19 TET distrib Value IV 20 TEST distrib Value Start verification click on Start and enter the name of the verification After the verification was finished acknowledge the message Verification successfully completed the verification report will be added on the verifications list
26. filter options After unselected all filter options choose only the option needed e g start test then click on Rebuild Report only test start will be displayed Filter 6 Rebuild Report Select All Unselect All v Audit OFF V Audit ON 224 a User s Manual _ rev2 0 May 2005 All options activated XLog 1 0 0 6 sorin Administrator Audit Actions Close Report View Filter Rebuild Report Ce IV V V V V V V V V V V V V V V V V V V V V V V V V V V V V Audit OFF Audit ON Audit Waring Battery Warning CRC ERROR Calib Deleted Calib Warning Compact Database Download Logger Import Test Logon Logon Failure Manage Members Option Changed Report Created Report Deleted Report Reviewed Reset Test Setup Loggers Start Data Collection Start Test Stop Calib Verif Stop Data Collection Stop Test Take Ownership Template Reviewed Test Deleted Test FConf Chang Verif Deleted Page 1 6 Page 1 of 6 Printed 29 05 2005 18 02 25 from C og_0 6 delta dxa ini Audit report Events shown Audit ON Audit OFF CRC ERROR Logon Failure Logon Reset Test Start Test Stop Test Stop Calib erif Start Data Collection Stop Data Collection Import Test Setup Loggers Download Logger Take Ownership Option Changed Manage Members Test F Conf Changed Audit DB created Audit Warning Report Created Report Reviewed Test Deleted Verif Delet
27. 0 0 0 No login Administrator lest Repor Actions Q HAm Save Report As Test Image Test New Test Input e D A Input Module All Assigned 79003 10562 Licensed to IFL 1 0 0 6 SN 26674 01036 Evaluation Equip Info Autoclave FED 005 Serial Number 12345 67890 Location Production injectables autoclave Hydi View Report Trend Statistics Trend Report Saturation Template Report Test Image Image Report Settings F Config Saturation Config Report Intervals Saturation Config Report Intervals Assign Mert Virtual Chan Add Info Assign Verif Virtual Chan Add Info XpertVal Printed 13 06 2005 20 50 40 from C valFI D Gul A e 55 User s Manual _ rev2 0 May 2005 XpertVal Save report in order to sign the test report Mew Report x Input Report Name Butoclave Validation Report o The report will be saved as a sub report of the main report Name Compiled Instrument Scans GUID KY Test 2 13 06 05 20 21 27 63573021 22 0B495997 D51 FJ New Test 13 06 05 19 50 50 63573021 155 75B69424 431 Hamme Created Reviewed ____ 13 06 05 20 52 56 gt Autoclave Tm Report 56 User s Manual _ rev2 0 May 2005 XpertVal Data Logger used as stand alone unit data acquisition without computer Data is stored on two media during data acquisition PCMCIA card PC file In order to use the data logger as a stand alone system Config
28. 0 01 09 E H Overheating 13 06 05 20 01 17 K E j H Overheating 13 06 05 20 01 23 F Overheating 130605 20 01 31 E E E Overheating 13 06 05 20 01 39 E E i Overheating 130605 20 01 47 E E Overheating 13 06 05 20 01 55 E E A Overheating 13 06 05 20 02 03 418 POL 3 ERROR Click on Template Report to see template report js XValFL 1 0 0 6 No login Administrator Test New Test o m 1 1 Template CB50E513 25BA 4606 83AC 7D i Printed 13 06 2005 19 57 24 from Ciy 1 Template Template for autoclave XWalFL 1 0 0 6 SN 26674 01036 79003 10562 Weenche Evaluation Hydra Id 63573021 Module Id 1 Hydra Interval 0 08 hh mm ss Scan Rate SLOW F Config Steam Z Valuez 10 0 C To Temp iEn D C Min Temp To Calc pe 4118 0 C Steam Saturation Temp Chan 01 Press Chan 00 Pressure Unit bar Tolerance rr Temp 90 0 Error Allowed 1 0 C Check Time 1 00 mm ss at 130 Temp 131 0 C Error Allowed 1 0 C Check Time 1 00 mm ss at 121 Temp 121 0 C Error Allowed 0 2 W C Check Time 1 00 mm ss Drift Allowed 0 10 C Dev From Refer Alowed 2 0 4 C Check Time For Drift 1 00 mm ss Mrtual channels 20 Delta Max 1 20 Mn 1 20 Input Module Chan 5 Assign Label Cal Allowed Input Output M val 00 Press 0 10 0 5 0 50000 01 drain 1 00000 1 00000 1 00000 1 00000
29. 005 Create trend report Click on Trend then New Trend Report Page to create new pages in the trend report Enter the name for this first page and Ok SR mi p Enlarge the dwell of the report then click on New Trend Report Page to create a new page in the trend report Then click on Trend Report the trend report will have two pages containing information defined previously Follow the same procedure to add extra pages in the trend report XValFL 1 0 0 6 No login Administrator Test Report Actions Q Miel Save Report As Trend Report Trend Report Input A Input Module All Assigned View Report Trend Statistics amp Trend Report Saturation Template Report Test Image Image Report 13 06 2005 20 43 51 13 06 2005 20 45 30 Pae TI 2 Z 54 XValFL 1 0 0 6 Input A Input Module All Assigned View Report Trend Statistics Trend Report Saturation Template Report A Test Image Image Report Settings F Contig No login Administrator Test Report Save Report As User s Manual rev2 0 May 2005 Insert image in the test report Click on Test image then on the image icon fice XValFL 1 0 0 6 No login Administrator Test Report Actions Save Report As Define the location where the image is stored to insert it in the report Click on Image Report the image report was created automatically by the software
30. 01 0 00 0 00 0 00 0 01 0 01 0 01 0 01 0 00 0 01 0 00 0 00 0 01 0 01 0 00 0 00 0 00 0 00 0 02 Ag 120 507 0 065 0 035 0 036 0 048 0 031 0 040 0 041 0 045 0 051 0 028 0 035 0 039 0 030 0 041 0 031 0 038 0 043 0 033 004 0 043 V 07 Max 120 531 0 15 0 11 0 11 0 14 011 0 13 0 13 0 11 0 14 0 10 0 11 0 13 0 12 0 13 0 11 0 12 0 12 0 13 0 14 0 12 jv 8 Status OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK v 9 v Performed 12 06 05 18 30 51 Reviewed Click on Add info for adding comments in the header of the verification report Comment ES TII FS Description omments for verification report Cancel _4 XpertVal User s Manual _ rev2 0 May 2005 XpertVal 3 2 9 Action Test To start a new test go in Test New connection with data logger will be verified before starting the test amp Equipment Verification FLUKE 26354 b M6 9 45 02 D 1 0 L0 8 1 38400 63573021 Unit C BPC Instrument Time 22 51 11 12 juin 05 Memory Card is OK Size 256 K Free 238 K Num Of Files 1 Three options are available to start the test clear Hydra and search for calibration clear Hydra and test without calibration upload configuration from Hydra and continue test Start new test using option clear Hydra and search for calibration Software will automatically display the calibration Pen Clear Hydra and Search for Calibration Clear Hydra and Test w o Calibration
31. 01 20 If you need to modify anything in the configuration you can make it now otherwise click on Start to start the test As described two types of studies are available Distribution Value used for mapping the sterilization equipment no F value calculations Penetration Fvalue used for studying the effect of the temperature inside the product temperature value acquisition and F value calculations Test configuration Define data acquisition interval Intervals In the test configuration click on the Cfg Define the support you want data to be stored on save to Hydra memory card save all data on the PCMCIA card of data logger Save to Dbase save all data in data base of the computer BER v Save To Hydra Memory Card Fast Hydra Scan Rate Hydra Interval h mm ss 0 08 v Save To Database Define data acquisition speed enable or disable Fast Hydra Scan Rate Define data acquisition interval by using the up and down arrows The minimum data acquisition interval is 1 second Data acquisition interval in the data base is equal or multiple of Hydra data acquisition interval 43 User s Manual _ rev2 0 May 2005 XpertVal WARNING Data accuracy is decreased when Fast Hydra Scan Rate option is used n Rate FAST oO CH5 CH6 om la o a a CHE CHH cho Chi chi Chie CHE Chl Chill Tc T Tc T Tc T Tc T Tc T Tc T Tc T Tc T tempi tempt tmpt t
32. 2005 mai 23 New test 8 2005 mai 23 Neu test 8 2005 mai 23 Neu test 9 2005 mai 23 New test 9 Ze Administrator at LIVES SERVER Sorin Haias sorin Setup Loggers Sorin Haias sorin 21 05 05 22 07 00 CRC ERROR sorin 21 05 05 22 07 02 Logon 22 05 05 00 36 56 CRC ERROR sorin 22 05 05 00 36 57 Logon 22 05 05 01 51 04 Logon 23 05 05 02 24 23 Test Deleted 23 05 05 02 24 33 Test Deleted 23 05 05 11 06 30 Logon 23 05 05 11 07 08 Start Test 23 05 05 11 07 24 Stop Test 23 05 05 12 38 18 Logon 23 05 05 12 38 51 23 05 05 14 04 17 23 05 05 14 05 59 Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Start Test Stop Test Download Logger Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin 23 05 05 14 06 35 Setup Loggers Sorin Haias sorin 23 05 05 18 19 38 23 05 05 18 25 14 23 05 05 19 39 46 23 05 05 19 40 28 23 05 05 19 41 34 23 05 05 19 44 51 23 05 05 19 47 11 23 05 05 19 47 37 23 05 05 19 48 42 23 05 05 19 49 50 23 05 05 19 49 36 23 05 05 20 46 56 23 05 05 20 47 57 23 05 05 20 59 09 23 05 05 21 02 08 23 05 05 21 03 01 23 05 05 21 04 18 Start Test 23 05 05 22 46 53 Stop Test 23 05 05 23 20 08 Logon Start Test Sorin Haias sorin Stop Test Start Test Sorin Haias sorin Sorin Haias sorin Stop Test Start Test Sorin Haias sorin Sorin Haias sorin Stop Test Start Test
33. 24 05 05 01 41 34 24 05 05 02 34 21 24 05 05 09 33 31 24 05 05 09 35 11 24 05 05 09 36 14 24 05 05 09 44 20 24 05 05 10 13 31 24 05 05 10 34 05 24 05 05 12 33 30 24 05 05 12 35 55 24 05 05 13 32 55 24 05 05 14 00 54 24 05 05 16 33 04 24 05 05 16 58 47 24 05 05 17 07 16 24 05 05 17 14 05 24 05 05 17 15 42 24 05 05 20 35 20 24 05 05 20 36 13 24 05 05 20 38 11 24 05 05 22 40 03 24 05 05 22 46 04 24 05 05 22 47 45 Event Audit DB created Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test Start Test By sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin H
34. 8 1738400 63573021 Unit EC EXPE Instrument Time 20 59 46 13 juin 05 Memory Card iz OF Size 256 K Free 217 k Num Of Files 4 pen Mew Combine Test Listing Hydra Scanning tif in progress will be terminated Proceed amp Import from Hydra from File Nam Spe DateTime Cancel a lx DATOO HYD 8274 12 06 2005 16 26 13 DATOO HYD 8274 C3 DATOT HYD 15706 13 06 2005 13 50 B DAT 1 HYD 15706 C3DATO2HYD 2938 13 05 2005 20 21 Delete C3DATO2HYD 2938 C3 DATO3 HYD 2266 13 06 2005 20 56 DATOR HYD 2266 13 06 2005 20 56 Format MC Save to Save to Name JL Size DateTime 12 06 2005 16 26 13 06 2005 19 50 13 06 2005 20 21 XpertVal Program hfiles Program hfiles Click Import and name test report Import O x Brunnen Loading file DATOS HY D from Hydra from File Cancel isi DATOD HYD gard 12 06 2005 16 26 3 DATOT HYD 15706 13 06 2005 19 50 3 DAT 2 HYD 29368 13 06 2005 20 21 Format ME Input Test Name Test imported mea Save to Progranm htiles 58 User s Manual _ rev2 0 May 2005 XpertVal The file will be imported in the test list Ze X alFL 1 0 0 6 No login Administrator Tests ad e S AREA Compiled Instrument Scans GUID ama x Testimpoted ae imported ges 53573021 Test Data R
35. A card and in a file on the hard disk The system meets European and American requirements concerning thermal validation processes electronic data protection and data signature User s Manual _ rev2 0 May 2005 XpertVal 1 2 Concept XpertVal is the latest generation in Lives International s line of thermal validation systems It is a compact modular and portable instrument designed specifically by Fluke to meet current thermal validation needs and regulations The XpertVal can accommodate up to 20 sensor inputs in any combination of thermocouples PT 100 thermistors voltages or current inputs Sensor input is accomplished through a Input Module a modular sensor input interface that protects the electronics against dust humidity electrical noise and mechanical shock The module has 20 sensor input channels a cold junction reference to maintain measurement accuracy in different environmental conditions The temperature measurement range is 200 C to 500 C depending on the type of thermocouple and selected resolution used with a total system measurement accuracy of 0 191 C at 121 0 C XpertVal System can easily be connected to a data logger Fluke to temperature standards or reference baths Lives or Hart This modular design allows for fully automatic sensor calibration as well as multiple calibration or test equipment configurations XpertVal software is designed to run on Windows 95 98 2000 NT or XP and provides everything need
36. C file Standard test reports directly from the PCMCIA card Stand alone unit during test no need to use a PC during test test User friendly software Flexible software Software validation manual One day training after delivery IQ amp OQ provided Standard connectors Control of other manufacturers equipment Hart temperature blocks and smart probe IRTD User s Manual _ rev2 0 May 2005 XpertVal 2 XpertVal Equipment 2 1 Hardware equipment XpertVal validation system is composed by Data Logger Hydra with PCMCIA card Temperature Reference Probe Lives connected directly to the temperature block or Hart probe with display Temperature Block Lives XpertVal validation software PCMCIA card with 2 or 4 communication ports Notice When the Lives temperature block B series is controlled through the Lives probe connected it is strongly recommended that the block and the probe be calibrated together by a Lives International or Ametek calibration service The serial number of the probe must be entered in the block by the calibration service together with the correction coefficients for the probe The verification of the equipment in the software allows users to be aware if the serial number of the probe does not corresponds to the serial numbered recorded in the block Lives International declines all responsibility in case of incorrect use of probe connected to the temperature block 2 2 Minimal Configuration of Xper
37. Calibration or Verification in the Calibration Config window then Add Setup Equipment Administration aze Calib V erif Config w Verification F Value Config a at 90 Cancel RTD amp Block Calibration RTD amp Block i D marrer D 4 O 12 XpertLog BY Microsoft Word Manual XLog 1 0 0 6 H LALO DSO E MI om To modify the settings of the set point click on the specified set point and modify temperature error allowed check time for error by using the arrows next to each parameter In order to increase or decrease the value bytenth hold simultaneously Ctrl Shift and click on the arrow up or down byunits hold only Ctrl and click on the arrow up or down bydecimals click on the arrow Calibration Config x Calibration Config aes 3 Calibration HR 3 Calibration xq on ERE Calibration at 90 dM at 90 Verification at 121 vw at 130 M at 130 1 4 Verification Temp C 90 0 Verification Temp fC 121 0 vw at 100 ey at 100 iy at 121 at 121 3 6 RTD amp Block D RTD amp Block Error Allowed 7 C 0 5 Error Allowed C 0 1 v Check Time For Error mm ss 3 00 Check Time For Error mm ss 3 00 lt gt lt gt Define the drift for the reference probe by clicking on RTD amp Block
38. Drift Alowed 0 10 C Dev From Refer Alowed 2 0 4 Cy Check Time For Drift 1 00 mm ss Mrtual channels Maxval Meax 1 20 Min val Min 10 20 Delta tvtax 1 20 Min 1 20 Input Module Chan Func ign Label Cal Allowed Input Output M val KN 00 No 0 10 0 5 0 50000 901 Yes E E 1 00000 02 Yes 1 00000 03 Yes 1 00000 04 Yes 1 00000 05 Yes 1 00000 406 Yes E 1 00000 07 Yes 1 00000 08 Yes 1 00000 09 Yes 1 00000 10 Yes 1 00000 11 Yes 1 00000 12 Yes 1 00000 13 Yes 1 00000 14 Yes 1 00000 15 Yes 1 00000 16 Yes 1 00000 17 Yes 1 00000 18 Yes 1 00000 19 Yes 1 00000 20 Yes 1 00000 Mtaxval No Min val No Delta No n N UN i LAS A A i Km s T SSS B we PB NM Hw h NM k h B9 k h PB h h h k h h k h h KW Ge User s Manual _ rev2 0 May 2005 XpertVal 3 2 7 Action Calibration Pre Calibration Before starting a test study it is important to calibrate thermocouples used for test versus the reference standard in order to calculate correction parameters to be applied during the data acquisition After a test study you are requested to verify in one or more points if the thermocouples are within the specifications defined in the configuration module Principle of calibration The calibration is performed by comparing individual temperature values
39. Reset even if Data Collection Already Started Ava va B A uze neis B Ge H o o lt gt v Enable Value Triggered Data Reset Reset Only on Return Pass Through the Value v lt v 1000 6 g Current w Value v of Channel Any All Avg 2 crave v aiue Triggered Test Duration lt lt gt Current v Value v of Channel I 0 v lt w 1000 Stop Test based on Temperature or F Value The Reset of the test can be programmed based on temperature value or F Value options are similar to the previous option Enable Start based on Temperature Value even for the F Value amp Test Config Intervals By Time By Value v Enable Value Triggered Start Of Data Collection v Reset even if Data Collection Already Started Avg v Value v of All Assigned as Y Press wd v 1000 v Enable Value Triggered Data Reset Reset Only on Return Pass Through the Value Current II Value v of Channel v M lt IF 100 0 wv Enable Value Triggered Test Duration Current v Value v of Channel v Any All Avg 48 User s Manual _ rev2 0 May 2005 Start Test XpertVal In test configuration disable all options By Time and By Value define interval 10 sec and start test New Test
40. The equipment connected to the computer will be verified click Ok to proceed amp Equipment Verification amp Verification mode Instrument FLUKE 26354 6357302 M6 9 45 02 D1 0 L0 8 1 38400 63573021 Unit C 266 PC Instrument Time 18 24 26 12 juin 05 Instrument PC Time Synchro will be performed when required wv Memory Card is OK Size 256 K Free 238 K Num Of Files 1 Probe LIVES Ext 6 9600 529154 03 Unit C Temp 121 098 C Verification of Serial Number is Recommended e Block LIVES 3125 ATC 157B 6 9600 524435 00141 Unit C Control External Choose the verification mode search for calibration verification without calibration Search for Calibration Verification w o Calibration 12 06 05 17 3 If a pre calibration have been previously performed it will be displayed in the calibration found list Select the calibration and proceed Double check the verification configuration by dragging the mouse on Verification Configuration X alFL 1 0 0 6 No login Administrator Yerification Actions Verification Not Started Ch Func Assign Label Start Verif oo 0 10 Ydc Press Verif Config 01 TET penetr drain Input 02 TC T penetr 03 Tel penetr m Input Module 04 Te T penetr All Assigned 05 Te T penetr 06 Te T penetr 07 Tc T penetr 08 Te penetr 09 TC T penetr 10 Te T penetr 11 Tc T distrib 12 Tc T distrib 13 TEST
41. X alFL 1 0 0 6 No login Administrator Test New Test Rebuild Report 00 r j1 Calibration autoclave Test Template Hew Test Template for autoclave XVaIFL 1 0 0 6 SN 26674 01036 79003 10562 Licensed to Evaluation Hydra Id 63573021 Module Id 1 Hydra Interval 0 08 hh mm ss Scan Rate SLOW F Config Steam Z Value 10 0 C To Temp 121 0 C Mn Temp To Calc F value 118 0 C Mrtual channels Maxval Max 1 20 Minal Min 10 20 Delta Max 1 20 Min 1 20 Dates time Aion ais To 20 Maxval Mnval Deta ro Foz ros roa ros ros y hh mm ss Func Te T Te T Te T Te T Te T Te T Te T Te T Te T Value Value Value Calc Calc Calc F Value F Value F Value F Value F value F Value ed Calib 1 1 1 1 1 D 1 1 1 OK OK OK E OK OK OK OK OK OK 1 00535 1 00930 1 00346 1 00842 1 00643 1 00628 1 00896 1 00440 1 00655 D 53 0 82 0 51 0 77 0 70 0 73 0 87 0 70 0 75 distrib distrib distrib penetr penetr penetr penetr penetr penetr 19 50 53 19 51 01 19 51 09 19 51 17 19 51 25 19 51 33 19 51 41 19 51 49 19 51 57 19 52 05 19 52 13 19 52 21 19 52 29 19 52 37 19 52 45 19 52 53 19 53 01 19 53 09 19 53 17 49 User s Manual _ rev2 0 May 2005 XpertVal Click on Trend to see real time trending for all channels gt XValFL 1 0 0 6 No login Administrator Test New Test Saturat
42. aias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin Sorin Haias sorin XpertVal Description 2005 mai 23 New test 1 2005 mai 23 New test 2 offset 308 311 312 313 offset corect 308 311 312 313 2005 mai 23 New test 3 2005 mai 23 New test 4 2005 mai 23 New test 5 2005 mai 23 New test 6 2005 mai 23 New test 7 2005 mai 23 New test 8 2005 mai 23 New test 9 2005 mai 23 New test 10 2005 mai 23 Neu test 11 2005 mai 24 New test 1 2005 mai 24 New test 2 2005 mai 24 Neu test 3 2005 mai 24 New test 4 2005 mai 24 New test 5 2005 mai 24 New test 6 at 38 83 C 2005 mai 24 New test 7 2005 mai 24 New test 8 2005 mai 24 New test 9 2005 mai 24 New test 10 2005 mai 24 Neu test 11 test D 38 29 150 2005 mai 24 New test 12 Printed 29 05 2005 18 09 41 from C og_0 6 delta dxa verification sondes mepac 307 308 311 313 2005 mai 24 New test 13 2005 mai 24 New test 14 2005 mai 24 New test 15 2005 mai 24 New test 16 2005 mai 24 New test 1 2005 mai 24 New test 18 2005 mai 24 New test 19 2005 mai 24 New test 20 2005 mai 24 Neu test 21 2005 mai 24 New test 22 2005 mai 24 New test 23 2005 mai 24 New test 2 2005 mai 24 New
43. ammed prior to shipment from the factory In order to program the serial number into the Hydra EEPROM the Terminal Program HyperTerminal RS 232 should be used to establish PC HYDRA communication see User Manual Start a new HyperTerminal session Comm 1 Bauds 38400 Data 8 Parity None Stop bit 1 Flow control none then File Properties Parameters ASCII configuration check the 2 upper boxes in the window send EOF and locally write the characters To check if the serial number has been previously programmed use SERIAL at the Terminal prompt If Hydra responds with 0 then serial number has not yet been set The following procedure should be used to program the serial number into the EEPROM e Atthe Terminal prompt use the SERIAL XXXXXXX command XXXXXXX denotes the 7 digit serial number HYDRA ID Tag Leading zeros must be entered Note once entered the number cannot be changed e Check if the serial number has been programmed use SERIAL at the Terminal prompt If Hydra responds with XXXXXXX representing the serial number then serial number has been set correctly e Stop the HyperTerminal session 10 User s Manual _ rev2 0 May 2005 XpertVal IV Programming the HART module s 1502A Serial Number Connect the Probe to the module 1502A Connect the power supply to the module Turn On the module Set the baud rate e Press the Menu button Set
44. antaneous lethal rate at To 121 1 C is Fo 1 minute The sum of the instantaneous lethal rates over the course of a cycle yields the accumulated lethality delivered and is calculated using the following equation Fo 5107 121 19 C 10 C At Where At The chosen time interval in minutes T Average temperature over the At interval in C To determine the log reduction achieved by the sterilization the accumulated lethality is divided by the D value as shown in the following equation LR Fy D Where LR Log reduction Fo The accumulated lethality using Ty 121 1 C and Z 10 C D The D value of the microbial population Choose the F Config module from the main menu Choose the study type steam dry heat with or without depyrogenetion Define the Z value and the reference temperature value for F calculation Define the minimum temperature from which the F Value will start accumulating MISES ls GER Steam v Dry Heat Without Depyro v Dry Heat with Depyro v Z Value C 10 0 2 Value C 21 0 e Z Value C 47 6 e To Temp C 121 0 Tx Temp C 1700 Tp Temp C 250 0 Min Temp To Calc F Value C 118 0 Min Temp To Calc F Value C 150 0 Min Temp To Calc F Value C 240 0 Click on OK to validate the choice of the parameters for F value calculation or Cancel for returning in the main menu The F value calculation configuration may be de
45. better understanding and simplicity of use The structure of the software modules Setup Equipment Administration Calibration Verification Configuration F value configuration Action Equipment Info Template Calibration Verification Test Import Application Help About Exit 16 XpertVal User s Manual _ rev2 0 May 2005 XpertVal 3 2 1 _Setup Equipment Equipment Configuration Available Three types of connections are available Type I e Data logger Hydra 2635A Temperature block Lives Reference probe Lives connected to Temperature block Lives Type Il Data logger Hydra 2635 A Temperature block Lives Hart Reference probe Hart with external display Ametek DTI with external display Kaye IRTD Type Ill Data logger Hydra 2635 A e Oil bath Hart Reference probe Hart with external display Ametek DTIwith external display Kaye IRTD The recommended connection is Type I in order to improve the accuracy of the calibration the reference probe is connected direct to the block through the front panel in order to control it highest accuracy calibration then if the block is controlled by it s internal regulation probe only 2 COM connections needed for calibration all equipment are stored in a single carry case General case presentation block reference probe and data logger connected to PC via 3 communication ports 174 User
46. box will display the connection status between the data logger the temperature standard the temperature block and the computer figs Equipment Verification Instrument FLUKE 26354 5357302 M6 9 A5 02 D 1 0 L08 1738400 53573021 Unit C SPE Instrument Time 13 54 02 12 juin 05 lnstrument PC Time Synchro wll be performed when required Memory Card is OF Size 512 K Free 462 K Num Of Files 3 Probe LIVES Ext 69600 523154 03 Unit C Temp 20 020 C Verification of Serial Number is Recommended LIVES 3125 ATC 157 B 649600 524435 DU1 41 Unit C Control External For each equipment connected the system will display important information identification the serial number the firmware version the communication port on which the equipment is connected the engineering units C F K the status of the PCMCIA card the size of the card the number of files already recorded and the amount of space available In order to format the memory card of Hydra click on Format MC A warning message will than be displayed in order to prevent lose of data from the memory card Hydra Scanning tif in progress will be terminated Proceed Format Hydra MC requested Proceed Actions Refresh Ports Verify Sa Caric l Hydra Probe Block Mode Comm Port IM Port 6 modem v Baud 9600 v Type LIVES Ext I Digits 30 00 e
47. by using the up down arrow keys Select 38400 press Enter SHIFT LIST Baud 38400 ENTER PAR no ENTER CTS OFF ENTER Echo OFF ENTER User s Manual _ rev2 0 May 2005 XpertVal II Initializing the PCMCIA memory card Selecting the initializing mode Insert the memory card to be initialized From the front panel of Hydra Press on the FILES menu Press the up down arrows until Init is displayed the press Enter key The menu changes to Init Verifying the Init mode To verify the selection of the initialization mode press the up down arrows keys until yES is displayed in the Init menu then press the Enter key If yES is selected the menu changes to SUrE Initializing the memory card Press the up down arrows keys to select yES in the SurE menu then press the Enter key VES will initialize the memory card erasing all previous data if any If Err 1 Card appears the small switch on the card may be in the write protect position Reposition the switch and repeat this procedure If the memory card can not be initialized in this way go to the next steps and use option VI A for initializing the card III Programming the HYDRA Serial Number In order to use the HYDRA within the XpertVal software the Serial Number of the Hydra must be programmed into nonvolatile EEPROM of the instrument Note that the serial number is not progr
48. e amp Time W 01 02 03 04 06 07 08 09 10 2 Input Module 2 dd mm yy hh mm ss Func Te T Te T Te T Te T c Te T Te T Te T Te T Te T 2 Set F Value F Value F Value F Value ue F Value F Value F Value F Value F Value All Assigned 2 Used Calib Calibration autoclave gi Calib Status OK OK 0K OK OK 0K OK 0K OK View 2 Meval 1 00842 1 00643 1 00628 1 00896 1 00655 1 00650 1 00493 1 00626 1 00432 4 2 B Val 0 77 D 0 0 73 0 87 0 75 0 76 0 77 0 75 0 58 Grid 2 Pesign penetr penetr penetr penetr penetr penetr penetr penetr penetr g Label drain z gt 3 10 00 03 E Data Collect Report G Start 13 06 05 19 50 53 ON Trend 2 E End 13 06 05 20 01 23 R A Statistics F Config Steam Z Value 10 0 C To Temp 121 0 C Mn Temp To Calc F Value 118 0 C Saturation in 23 80 23 88 23 89 23 84 23 92 23 92 23 91 23 84 23 85 23 92 84 47 83 13 83 07 83 83 84 77 83 36 83 44 84 07 84 74 83 23 Template Report ange 60 67 59 25 59 18 59 99 60 85 59 44 59 53 60 23 60 89 59 31 40 552 39 790 39 761 40 174 40 869 39 952 39 986 40 320 40 748 39 863 DD 0 0 0 0 0 0 00 0 0 0 0 0 0 0 0 0 0 10 43 KO 00 04 Iz Data Collect 51 User s Manual _ rev2 0 May 2005 XpertVal Click on Saturation to see saturation report XValFL 1 0 0 6 No login Administrator Test New Test Bi 19 SIO E GDS 20 01 0 verheating D 01 ZER 0 168 459 0 539 130605 2
49. ed Calib Deleted Report Deleted Template Reviewed Compact Database Calib Warming Battery Waming Date Time Event By Description 21 05 05 19 11 39 Audit DB created sorin 21 05 05 19 11 41 Faudit Waming 21 05 05 19 11 41 Logon 21 05 05 19 13 56 Sorin Haias sorin Database location changed from C Xdog wersionsUlog 152 delta dxl to C dog_0 6 delta dxl As Administrator at LIVES SERVER Start Time 21 05 05 19 15 00 Stop Time 21 05 05 23 38 00 Interval 1 Loggers 105 File CRC Error C og_0 6 delta dxl As Administrator at LIVES SERVER File CRC Error C og_0 6 delta dxl Ae Administrator at LIVES SERVER As Administrator at LIVES SERVER 2005 mars 29 Neu test 4 2005 mars 20 New test 3 As Administrator at LIVES SERVER 2005 mai 23 Neu test 1 2005 mai 23 New test 1 Administrator at LIVES SERVER 2005 mai 23 New test 2 2005 mai 23 Neu test 2 Logger 306 Start Time 19 05 05 17 59 24 Stop Time 19 05 05 19 18 24 Interval 60 M 1 00000 B 0 00 Start Time 23 05 05 14 15 00 Stop Time 23 05 05 18 00 00 Interval 5 Loggers 306 offset_308 311 312 313 offset 308 311 312 313 offset corect 308 311 312 313 offset corect 308 311 312 313 2005 mai 23 Neu test 3 2005 mai 23 New test 3 2005 mai 23 Neu test 4 2005 mai 23 Neu test 4 2005 mai 23 New test 5 2005 mai 23 Neu test 5 2005 mai 23 New test 6 2005 mai 23 Neu test 6 2005 mai 23 New test 7 2005 mai 23 Neu test 7
50. ed by the manufacturer if available Verify in the Control panel that 2 or 4 depending upon the type of PCMCIA comm card available extra COMM ports are available 11 User s Manual _ rev2 0 May 2005 XpertVal VI Connecting data logger reference probe and temperature block on XpertVal software Insert the PCMCIA comm card into the computer Start up the computer Connect Hydra to Comm 1 standard RS232 comm port of the computer Connect reference probe to one of the two extra comm ports available Connect temperature block to the second extra comm ports available Start XpertVal Press Equip Select Hydra Port 1 Baud 38400 Module 0 Probe Mode Comm port Port 4 or one available Baud 9600 Type HART for a Hart probe IQRTD for a Kaye smart probe DTI SI for Ametek probe Lives for Lives probe connected to the block Block Mode Comm port Port 4 or 5 or 6 or 7 Baud 9600 for Jofra blocks 2400 for Hart blocks Type Lives or Hart Click on Verify Data concerning all the equipment should be available on the screen VIA Press Format MC in order to format the PMCIA card of the data logger If data concerning the equipment is not available check the connection to the computer VII Configure the computer to read data from the PCMCIA card Win 98 Use Word Pad to edit Config sys from C directory Add two more lines at the end of Config sys as follows
51. ed to perform validation testing Using XpertVal software a system administrator creates user accounts and assigns user IDs passwords and access permission levels that identify the person operating the instrument and prevent unauthorized operation Validation study setups which include calibration criteria are programmed using the XpertVal Software and can be run in standalone mode or under PC control The XpertVal also provides for encoded secure data files that prevent modification of the original data and includes data reporting options either as printed hardcopies or spreadsheet compatible electronic files This secure electronic data format is designed to satisfy the requirements of 21 CFR Part 11 Electronic Records and Signatures Data logger Hydra controlled by XpertVal has 2 MB of PCMCIA memory and 100 scans buffer internal memory The XpertVal is designed to write data to internal memory PCMCIA and PC hard drive if connected during sensor calibration calibration verification and test Hydra s PCMCIA card can be used to transfer Test data between the XpertVal Software and the data logger Calibration Calibration Verification and Test data is recorded to the hard disk in real time An external battery can be connected to Hydra data logger in order to provide electrical supply in case of a power loss The battery provides approximately 24 hours of power XpertVal is designed to operate with the Lives probe connected to the block w
52. eport Test Template Test imported aql FL 1 0 0 6 SM Z6674010 36 79003 10562 Licensed to Evaluation Imported from Hydra ID 63573021 13 06 05 21 06 15 Click on the From File tab to get the data from a file in the server if the data from the PCMCIA card has been stored in the company s server or from a location in the computer where data has been previously stored or click on the From Hydra tab in order to get data from the card inserted in the data logger Read data from the PCMCIA card in the computer OS Windows 98 In order to read PCMCIA card data directly from a portable computer OS Windows 98 you need to insert two control lines in the config sys file as follows device c windows system csmapper sys device c windows system carddrv exe slot n where n number of PCMCIA slots 59 User s Manual _ rev2 0 May 2005 XpertVal 4 XpertVal Technical Specifications 4 1 XpertVal Thermal Validation System Uncertainty XpertVal Validation system uncertainty under worst case after thermocouple calibration Data logger Hydra 121 C 250 C Conformity error 0 02 C 0 04 C A D Conversion error 0 02 C 0 02 C Compensation error 0 1 C 0 1 C Total logger uncertainty 0 14 C 0 16 C Calibration equipment Hart Reference probe 0 021 C 0 04 C Smart Display 0 01 C 0 02 C Temperature Block 155 320 0 02 C 0 02 C Total calibration Equipment uncertainty 0 051 C 0 08 C Total Xper
53. est Statistics Report Al Calculated values will R einitialize Saturation Status Test Template New Test Template for autoclave Ix XVAIFL 1 0 0 6 SN 26674 01036 79003 10562 Licensed to Evaluation Hydra Id 63573021 Module Id 1 Hydra Interval 0 08 hh mm ss Scan Rate SLOW Add Info Date amp Time Action 01 02 03 04 05 06 07 08 09 10 11 dd mm yy hh mm ss unc Te T Te T Te T Te T Te T Te T Te T Te T Te T Te T Te T Input t Set F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value Value z Used Calib Calibration autoclave 4 Calib Status OK OK OK OK OK OK OK OK OK OK OK amp Input Module 2 5 Mal 1 00842 1 00643 1 00628 1 00896 1 00440 1 00655 1 00650 1 00493 1 00626 1 00432 1 00308 All Assigned z B Val 0 77 0 70 0 73 0 87 0 70 0 75 0 76 0 77 0 75 0 58 0 44 L sign penetr penetr penetr penetr penetr penetr penetr penetr penetr penetr distrib View 5 Label drain Actions Grid Report Trend amp Statistics Saturation Reset Test Statistics Report Saturation Status Test Template New Test Template for autoclave Template Report XValFL 1 0 0 6 SN 26674 01036 79003 10562 Licensed to Evaluation Hydra Id 63573021 Module Id 1 Hydra Interval 0 08 hh mm ss Scan Rate SLOW Add Info Mrtual channels Maxval Max 1 20 Min val Min 10 20 Delta Max 1 20 Min 1 20 Fetion Input Dat
54. est report will automatically have three extra channels MaxVal MinVal and Delta XValFL 1 0 0 6 No login Administrator Template Config Configuration Virtual channels Template add info This menu is used for adding comments in the header of the report Comment Templates for autoclaves After having configuring the template click Save to save existing configuration New Template 1 xj Template for autoclave 34 User s Manual _ rev2 0 May 2005 XpertVal Template view report Open the template report saved previously and click on Report to view the template report X alFL 1 0 0 6 No login Administrator Template Config K ii EZ wz SIO Page 1 of 1 Template CB50E513 25 BA 4606 83AC 7004C93B4314 R 3 Printed 12 06 2005 15 50 55 from COM D Gut dg Configuration Template Template for autoclave XValFL 1 0 0 6 SN 26674 01036 79003 10562 Licensed to Evaluation Templates for autoclaves F Config Steam Z value 10 0 C To Temp 121 0 C Mn Temp To Calc F value 118 0 C Steam Saturation Temp Chan 01 Press Chan 00 Pressure Unit bar Tolerance 0 05 Calib at 90 Temp 90 0 Error Allowed 1 0 4 Cy Check Time 1 00 mm ss at 130 Temp 131 0 C Error Allowed 1 0 44 Cy Check Time 1 00 mm ss Verify at 121 Temp 121 0 C Error Allowed 0 2 4 Cy Check Time 1 00 mm ss RTD
55. ev2 0 May 2005 3 2 2 _Setup Administration Equipment Options 1 XLog 1 0 0 6 sorin Administrator Administration y Audit Trail E fS Auto Name Format Administration Windows XP XpertVal Use External probe Lives block control if available the external probe will be used to control the temperature block if a model B was chosen Style define the type of style needed Windows sP Flat Office P Metal Raised wiet _ V Administration will define members rights Equipment EE ER e Members Admins f Reporters f Reviewers E Database E Audit Trail Saturation Table EC Auto Name Format Template en Report i Verif Administration Delete Tests Delete Vert and Calib gt Delete Templates Use Only Reviewed Templates RSR m gt D gQ age 3 D O KI E q 2 a o Export Import Verif and Calib o Create Statistics gt Design Reports o Save Reports gt Review Reports Allow To Review Own Reports Show Action Hints Highlight Errors in Report Allow to Delete Reviewed Ite Logon Required to end Calib CI KI KI KI USES j SS E Admin User Admin User Admin User Off Admin User Admin ser Admin ser None Admin User Reporter Admin Reviewer On On On On Off me E Reporters Reviewers E Database vi Audit Trail Saturation T able c Auto Name Format Template
56. fined or started from the main menu or started from any module calibration or test If the F configuration is done starting from the main menu the values will be considered as default values for the system If the F value configuration is done starting from another module the specified values will be available only for the active test 28 User s Manual _ rev2 0 May 2005 XpertVal The F value used to evaluate the efficiency of a sterilization process 1s the time necessary to produce a certain sterilization effect F value is defined as the time in minutes to produce the equivalent sterilization effect at 121 C 250 F Z value is defined as the temperature change in C required to cause a one log reduction in the D value D value is the measure of the relative heat resistance of an organism at a constant temperature The most commonly used value of Z for the destruction of microbial spores is 10 C 18 F This is based on experimental observations for Baccilus Stearothermophilus a highly heat resistant organism 29 User s Manual _ rev2 0 May 2005 XpertVal 3 2 5 Action Equipment Info XpertVal is based on a equipment information templates system which allows the user to define and store all types of equipment with specific description serial number location etc The equipment information will then be stored in the header of the test corresponding to the equipment DO XLog 1 0 0 6 admin Administra
57. hat was in progress will be repeated after the calibration system stability conditions have been met After calibration was finished the thermocouple wires are verified to confirm that the error after calibration is within the user specified thermocouple error allowed This verification is performed for the duration of the check time for error and typically performed either at the same temperature for single point calibration or the middle point for the Low and High temperature for two point calibration Any thermocouple wire not meeting the user specified criteria of thermocouple error allowed will be set OFF Performing the calibration The software will display the set point specified in the configuration and will wait until the temperature standard drift is stable The calibration can start only when the drift of the temperature standard is within the limits defined by the user Usually it is recommended to configure a drift of 0 05 C and check time for drift a time of 1 minute The user normally set these configurations according to the company s internal validation S O P When the drift of the temperature standard is stabilized the system will start thermocouple calibration In the low and high calibration points the software records and displays the error of each thermocouple versus the temperature standard and compares it with the error defined by the user in the calibration configuration If the error of a thermocouple is higher than t
58. he accepted error the thermocouple will not be taken into consideration by the system for further operations and will be highlighted in red The cause of errors is in most cases a bad insertion of thermocouples inside the well of the temperature block In this case if some thermocouples are highlighted in red you can cancel the calibration and verify the way in which thermocouples are inserted in the wells If this is not the case this means that the thermocouple wire is defective and it has to be replaced Restart the calibration after checking the thermocouples or after replacing the defective ones In order to eliminate the errors of the thermocouple versus the reference probe the software will apply correction factors using the polynomial function y mx b In the verification point the software will apply the correction and verify the temperature values Corrected values will be displayed on the screen The correction factors will also appear in the calibration report as M value and B value 36 User s Manual _ rev2 0 May 2005 XpertVal In Calibration module click on New software will verify connections between computer and the equipment connected Acknowledge by clicking Ok if all connections are correct Click on Start to start the calibration and enter the calibration name A ti rt amp Equipment Verification UO Instrument FLUKE 26354 6357302 M6 9 45 02 D1 0L0 8 1 38400 63573021 Unit C 26 lt PC In
59. i em n v 12 Te T temp n Iv 13 Te T temp z Iv 14 Te T temp n Iv 15 Te T temp r Iw 16 Te T temp n Iv 17 Te T temp D Iv 18 Tec T temp E v 19 Te T temp Iv 20 Te T temp Template steam saturation Define the steam saturation report in order to be able to do it you need to define at least one pressure channel Click on Steam saturation and define the channels which are going to be used for steam saturation calculations based on temperature and pressure channel Generally the tolerance accepted is 50 mBar absolute but user will enter this tolerance based on internal SOP jig Steam Saturation Cfg iol xl v Enable Steam Saturation Temperature Chan 01 temp Wi Pressure Chan 00 Press y Pressure Unit E bar y Tolerance 0 050 bar Template calibration and verification configuration Click on Calib Config to define the calibration and verification configuration Follow instructions defined in the Calibration Verification Configuration module to configure the calibration and verification in the template 33 User s Manual _ rev2 0 May 2005 XpertVal Template virtual channels Use has the ability to insert his own calculations which will be displayed as separate channels in test report Examples of calculations Yirtual Channels Maxval max 2 01 20 MinVal min 10 20 Maran d F Delta max 01 20 min 01 20 Delta max 01 20 min 01 20 The t
60. ion Status Test Config Add Info Input Z Input Module All Assigned View Grid Report Trend Statistics Saturation Template Report Mon 13 Jun 2005 brise B 15 02 B 00 01 Select or unselect the channels to be displayed on screen right click on green zone where the channels are displayed and choose one of the options Filter 30 IV 20 F Magal ET v Show Annotations F Deta Select All 16 09 G 00 9 Unselect Al Select only FValue Select assigned as Press Select assigned as penetr Select assigned as distrib Select mu Value Trend Setup Mark Data Points Thin Line Thick Line Medium Line 50 User s Manual _ rev2 0 May 2005 XpertVal Click on Statistics to see intermediate statistics click on Reset Test to calculate statistics from start test to end test Reset of Calculated Values during Test Study In order to either mark the beginning or the end of some operations or actions the user may reset the calculated values of the data logger When resetting these values the old information will still be available in the test report The Reset message appears on the report and on the trends This will also be a mark for the Statistics calculations The main purpose of the Reset function 1s to clearly define an interval inside which the users need to make the specifics calculations The data l
61. ith Hart probe model 1502 and Kaye IRTD and the Hart and Lives temperature blocks or cryo bath The equipment provides NIST traceable calibration of thermocouples used in thermal validation studies with a range of 183 C to 420 C During calibration and or test the XpertVal automatically reads and monitors the temperature of the reference probe For thermocouple calibration the reference probe functions as the standard for correcting thermocouple readings The Temperature References provide highly stable temperature conditions for sensor calibration and respond to pre programmed calibration criteria allowing automatic thermocouple calibration at both low and high temperature set points with an optional third set point for a mid range temperature check The significant improvement of calibration accuracy and speed in thermocouple calibration with XpertVal is obtained by using the exclusive features of Lives temperature blocks connection of the reference probe directly to the block the correction coefficients of the reference being stored in the memory of the block User s Manual _ rev2 0 May 2005 XpertVal 1 3 Advantages Security of data Data logger serial number control operation A Pyramid operations Based on Templates gt Calibrations Based on Calibration gt Tests Test Reduces the thermocouple calibration period in comparison to a manual calibration Reproducibility of results using completely automatic calib
62. j amp Report E Verif Administration 5 Delete Vert and Calib Use Only Reviewed Templates m x D 3 D 5 m 5 2 gt Export Import Verif and Calib gt Create Statistics gt Design Reports e Save Reports gt Review Reports Allow To Review Own Reports V Show Action Hints Je Highlight Errors in Report V Allow to Delete Reviewed Ite Logon Required to end Calib Allow to Edit Th Coefficients SEE Admin ser Admin ser Off Admin ser Admin User Admin User None Admin User Reporter Admin Reviewer On On On On 22 User s Manual _ rev2 0 May 2005 XpertVal Options available delete tests double click and define the level allowed for the action delete Verif and Calib double click and define the level allowed for the action delete templates double click and define the level allowed for the action use only reviewed templates enable or disable the option export import tests double click and define the level allowed for the action export import verif and calib double click and define the level allowed for the action create statistics double click and define the level allowed for the action design reports double click and define the level allowed for the action Save reports double click and define the level allowed for the action review reports double click and define the level allowed for the action allow to
63. mpt tupt tupt tmpt tupt Tr T Tc T Tr T Tc T Tc T Tc T Tc T Tc T Tc T i Vale Vale Vale Vale Vale Vale Vale Vile Emp tmpt tmpt tmpt tmpt tmpt tmpt tmpt tmpt t Hu Hu I I lh Gs Lh lh Vale Vale ale ale Ae Vale Vale ale Fr ie F 10 10 10 Lo 10 10 10 10 W W Fo No Ho M W W tb Dn Am Ap OO 00 0D 00l 10 10 m 10 10 10 10 10 10 Dg Ing Ing Dg Dg Ing Dg Dg 0 01 001 001 401 401 001 001 001 001 2 e Tez Tez Tez Dez Tez Dez Dez Dez Tez H 7 d H 7 H H a 21 HL 178 ALD ALI tH ALA a1j l 18 HALTS HILD 10843 HL HLS HLA 210 230 AA 2281 2280 228 2280 2231 2 2182 oun 2182 2124 HLS HLS 2135 Tii T Gu Tul TI W E K T3 TZ l 200 2160 HILT 2162 2172 HLS HAL 2136 Xl Td Tx Tx TI 210 210 T Tala 1 i0 2102 Tal 2100 2154 2158 EX Tid TA Td TG Tiu FAL Tali 2161 Til 2165 2175 2161 TILA 2135 210 T4 Tx Td TX 211 2190 Fly 2161 HILT 2165 175 2157 57 Tal 217 Xl 41089 218 42175 4315 HILS l Fast Hydra scan rate used Fast Hydra scan rate not used 44 User s Manual _ rev2 0 May 2005 XpertVal Delayed Start Reset or Stop data acquisition By Time Data acquisition can be configured by the user for delayed start reset or stop Ze Test Config Intervals By Time By Value v Enable Time Triggered Start Of Data Collection v Reset even if Data Collection Already Started Start Time Today v hh 18 mm 44
64. of each thermocouple wire to the NIST or COFRAC independent temperature probe A very accurate calibration can be performed if the RTD probe and the calibration block are of the highest quality as specified by LIVES International XpertVal allows user to perform completely automatic hands free calibration by controlling data logger reference probe and temperature block the block will automatically switch to Low High and Verif set points as defined in the Calibration Configuration In order to perform a reliable calibration the calibration system must be very stable The user s entered value for deviation from reference allowed defines the acceptable range of the actual temperature as compared to the set temperature calibration temperature The calibration can be performed either in single point or two point mode The stability of the system is defined as the value of the drift of the temperature allowed within a particular check time for drift When the calibration is started the RTD temperature will be verified every one second for the length of the check time for drift This is to assure that the initial conformity to the user s entered value for the drift of the temperature allowed has been satisfied At any time 1f the drift exceeds the limit the check time will restart The system stability 1s verified throughout the calibration and if at any time the calibration system stability conditions are not satisfied the part of the calibration t
65. ogger will automatically calculate Between the Start and the first Reset Between two successive Resets Between the last Reset and the End The users have the possibility of making calculations for the chosen period In this case the user needs to Choose the interval Ifthe calculation is done between two successive Reset Start interval first value after the first Reset Stop interval last value before the second Reset Example To delimitate a sterilization interval reset values as follows Define the beginning of a sterilization interval When the minimal value of all thermocouples is higher than 121 C or Manual synchronize with the autoclave indication of sterilization interval start Define the end of the sterilization interval When the minimal value of all thermocouples is lower than 121 C or Manual synchronize with the autoclave indication of sterilization interval stop Push on the Reset button at the beginning and at the end of the sterilization interval A message will appear reminding the user that the test is about to be reset and will ask for confirmation Click on Yes to proceed or on No to cancel All the values will be reset and then the system will restart the calculations from the reset moment chosen by the user XValFL 1 0 0 6 No login Administrator Test New Test rj xj d E i Confirmation i Actions 100 HDA i Bess Reset Ehe T
66. ollowing license agreement carefully Software License Agreement The enclosed software product the Software 15 developped by Lives Intemational and distributed by Lives International and by its representativs and is protected by copyright law and international treaty provisions By breaking this seal you agree to be bound by all the terms and conditions of this license agreement If you do not accept or agree with these terms you may vnithin fifteen 15 days return this entire package umsed and unopened together with all other materials in this program package to the company from whom you acquired it for a full refund prrsrssssssssesssssesssssesssssssssssssssssssssssessesssssesssessssssesssssssssssssssssssssssssssssseenai TTT TTT TTT C Ido not accept the terms in the license agreement Installshield lt Back Cancel i XpertLog InstallShield Wizard Installing XpertLog The program features you selected are being installed Please wait while the InstallShield Wizard installs xpertLog This may take several minutes Status Installshield lt Back Next gt User s Manual _ rev2 0 May 2005 XpertVal Z XpertLog InstallShield Wizard InstallShield Wizard Completed Version 1 0 0 6 XVa F L Company Evaluation Serial Num NA The InstallShield Wizard has successfully installed XpertLog Click Finish to exit the wizard Input serial number
67. onger be available For use The InstallShield Wizard has successfully uninstalled XpertLog Click Finish to exit the wizard If you want to review or change any settings click Back InstallShield i Cancel In order to completely uninstall the software the user needs to delete XpertVal folder from where it was installed 14 User s Manual _ rev2 0 May 2005 XpertVal Start XpertVal Version 1 0 0 6 X Lo g Company Evaluation Serial Mum 34905 75211 6226 7 25550 Settings database C xvalFl O xxxWLog3z edd Following problems detected Settings Database not Found Settings Database CRC Error Press Ok to continue Database not selected Supervisor Options Define a new data base a new audit trail will be generated automatically Create New Database Xx 1 Database CadxvalFl_O xxx 1 dxl created L 1 Audit File required For db C llx WalFl D veel Gd nat Found Mew audit File created and audit trail has been activated XpertVal starts gt XLog 1 0 0 6 No login Administrator Setup Equipment Administration Calib Verif Config F Value Config Action Equipment Info Verification Test Import Application A 2 First time when XpertVal starts the user will be logged on as Admin with no password required 15 User s Manual _ rev2 0 May 2005 3 2 Main Menu XpertVal 1s structured in modules for a
68. ration Specific and an individual data base for each equipment type Security and access levels programmable by the system administrator Electronic data protection and FDA 21 CFR part 11 Audit trails Automatic operation for thermocouples calibration Calibration and test reports generated automatically Display of real time data values amp trends Available reports Thermocouple calibration reports Test report Temperature values F values for penetration study Statistics Minimum values for each channel Maximum values for each channel Average values for each channel Real time trends Values The accumulated F values Intermediary reports during data Automatic start amp stop of data acquisition based on time or value Data acquisition down to 1 sec Channels configuration templates 20 temperature channels and 1 channel for an external transducer pressure humidity etc universal sensors connection on the data logger and controlled by XpertVal thermocouples PT100 Voltage 0 1 0 5 0 10 V Current 4 20 mA Thermistors Ete Label configuration of each thermocouple before test starting Easy handling of thermocouples initial connection in the data logger module Recognition of up to 10 modules with the corresponding calibration report Thermocouple oxidation detection by the data logger Raw data recorded on the PCMCIA card of the data logger and in a P
69. review own reports enable or disable the option show action hints enable or disable the option highlight errors in reports enable or disable the option aloow to delete reviewed items enable or disable the option logon required to end calib verif test and reset test enable or disable the option allow to edit the Thermistors coeff enable or disable the option Allowed for create OFF tine Tests UTS Admin User Reporter Reviewer Cancel Default Members Create new members on 4 different levels The administrator has the ability to modify the password change interval and the password minimum length Equipment dy SE Password Change Interval 90 Daye Import Members List from DB or file wh Reporters N Password Minimum Lenath d chars Reviewers E Database lt Audit Trail i we aR Format Password Change Interval 90 Days v Test Calib Password Minimum Length 4 chars Report erif Create a new member Click on the level needed to create new entry Click on New Member Define Login M l zici xi Password Retype password Login Access Level Redefine the access level MEN l 1 e Administrator Click Ok to acknowledge creation of new member lr C User Password Heats 1 Ee E The option Member must change password at next logon is used to giv
70. sing the up and down arrows An indication of the available time for saving data onto the PCMCIA card will be provided to the user Stop the software and do not stop data logger acquisition user cannot change data acquisition interval Click on Cancel and choose the Terminate and do NOT change current status of Hydra option By choosing this option the user has the possibility to start a new test with the same settings already loaded in the data logger Ges Test Termination 15 x O Terminate and Stop Hydra 3 Terminate and Continue Hydra Scan without PC Cancel ei Terminate and do NOT change current status of Hydra Lock Front Panel After Termination 53 User s Manual _ rev2 0 May 2005 XpertVal Test Report Double click to open the report Add information about the equipment which is validated using XpertLog click on Add Info and double click on the equipment choosed form the list Information corresponding to this equipment will be add in the header of the report z Comment 215 x Test Data Report Description Test Template New Test Template for autoclave FET 0 0 6 SN Z6674 01036 79003 10562 Licensed to Evaluation Exuip Info Autoclave FEO 005 Serial Number 12345 67890 Location Production oa autaclawe F Conta Srk 2 v Atual channels av al baxi 207 h n h n D 207 Delta baxi 205 wingi 207 v Autoclave FED
71. strument Time 16 00 42 12 juin 05 e Instrument PC Time Synchro will be performed when required qe Ca Memory Card is OK Size 256 K Free 247 K Num Of Files ncel Probe LIVES Ext 679600 529154 03 Unit C Temp 89 965 C Verification of Serial Number is Recommended w Choose the template to be used Double check the calibration configuration drag the mouse Block I s i LIVES 3125 ATC 157B 6 9600 524435 00141 Unit C to Calibration configuration and don t click on it The info bull Control External with calibration configuration will be displayed on screen i Select Template Lini xi Name ected Sa Template for autoclave 12 06 05 15 46 51 Template for freeze dryer 12 06 05 16 05 11 XValFL 1 0 0 6 No login Administrator Calibration Actions Calibration Not Started i pue Start Calib Calib Config Cur Value v 01 To T N Iz 02 IL I Calibration Configuration Calib D at 90 Temp 90 0 C Error Allowed 1 0 C Check Time 1 00 mm ss t 130 Temp 131 0 C Error Allowed 1 0 C Check Time 1 00 mm ss rify at 121 Temp 121 0 C Error Allowed 0 2 C Check Time 1 00 mm ss RTD Grid Drift Allowed 0 10 C Dev From Refer Allowed 2 0 C Check Time For Drift aT New Calibration X Input Calibration Mame Calibration autoclave SS
72. tVal Validation System Minimal configuration of XpertVal validation system XpertVal validation system 1s composed by Data Logger Hydra with PCMCIA card Temperature Reference Probe Lives connected directly to the temperature block or Hart probe with display Temperature Block Lives XpertVal validation software PCMCIA card with 2 or 4 communication ports PC laptop or desktop with Pentium III processor 1 0 Ghz 126 MB SDRAM Hard Drive 20 Go OS Windows 95 98 NT 2000 Xp Premium quality thermocouples Printer for reports printing or Adobe writer installed on the laptop WARNING The computer to be used with the system needs to have a clean operating system and it is recommended to be dedicated computer It is recommended to keep the computer clean of uncontrolled installations of other software which could affect the normal operation of the system 7 User s Manual _ rev2 0 May 2005 XpertVal 2 3 XpertVal Hardware Connections Temperature Reference Probe Temperature Block RTD Display Data Logger Hydra Fig 1 XpertVal equipment connections User s Manual _ rev2 0 May 2005 XpertVal 2 4 Hardware configuration I Configuring Hydra for Comm Operations Connect Hydra data logger to the computer by a null modem cable Turn the power On Selecting the Baud rate Press the Shift key release and then press the List key to open the communications parameters menu Select the baud rate
73. tVal validation system uncertainty A sum of data logger and calibration equipment 0 191 C 0 24 C B cf guide AFNOR XP X 07 020 square root 0 143 C 0 167 C of the sum of squares of each uncertainty Total system uncertainty maximum is 0 191 C 121 C amp 0 24 C 250 C Total system uncertainty typical 1s 0 1 C 121 amp 0 1 C 250 C 60 User s Manual _ rev2 0 May 2005 XpertVal 4 2 Data Logger Hydra Analog channels 20 by module Thermocouples J K N E T R S B and C Measures in C or F Functions Validation mode with XpertVal software Independent data logger Impedance channel input minimum 100 MQ in parallel with a capacity of maximum 150 pF NMRR 47 dB minimum 50 Hz 53 dB minimum 60 Hz CMRR 120 dB minimum 50 or 60 Hz 1 kQ lack 120 dB for continuously voltage 1 kQ lack Maximum input voltages 150 Vcc or Vea eff Thermocouple open detection the injection of a small alternative signal and the utilization of a detection techniques before each measure permit to detect a thermocouple open if the resistance is between et 4 kQ Power supply 90 a 264 Vca 50 or 60 Hz Battery of 9 to 16 Vcc automatically commutation between the source and the battery without electric alimentation interruption Dimensions 9 3 x 21 6 x 31 2 cm hx 1x p Weight 3 Kg 61 User s Manual _ rev2 0 May 2005 XpertVal 4 3 Temperature standard Temperature
74. test 25 Paen 1 d The default name for test or calibrations reports is suggested automatically by the software a 25 a User s Manual _ rev2 0 May 2005 XpertVal 3 2 3 Setup Thermocouples Calibration and Verification Configuration Thermocouples calibration The calibration is performed by comparing individual temperature values of each thermocouple wire to the NIST or COFRAC independent temperature probe A very accurate calibration can be performed if the RTD probe and the calibration block are of the highest quality as specified by LIVES International 7 XpertVal allows user to perform completely automatic hands free calibration by controlling data logger reference probe and temperature block the block will automatically switch to selected set points as defined in the Calibration Configuration g In order to perform a reliable calibration the calibration system must be very stable The user s entered value for deviation from reference allowed defines the acceptable range of the actual temperature as compared to the set temperature calibration temperature z The calibration can be performed either in single point two point or multiple unlimited points mode e The stability of the system is defined as the value of the drift of the temperature allowed within a particular check time for drift When the calibration is started the RTD temperature will be verified every one second for the leng
75. th of the check time for drift This is to assure that the initial conformity to the user s entered value for the drift of the temperature allowed has been satisfied At any time if the drift exceeds the limit the check time will restart The system stability 1s verified throughout the calibration and if at any time the calibration system stability conditions are not satisfied the part of the calibration that was in progress will be repeated after the calibration system stability conditions have been met After calibration was done the thermocouple wire is verified to confirm that the thermocouple wire error after calibration is within the user specified thermocouple error allowed This verification is performed for the duration of the check time for error and typically performed either at the same temperature for single point calibration or the middle point for the Low and High temperature for two point calibration Any thermocouple wire not meeting the user specified criteria of thermocouple error allowed will be set OFF 26 User s Manual _ rev2 0 May 2005 XpertVal Calibration Verification Configuration Select Calib Verif Config in the setup The thermocouple calibration and post calibration verification configuration module will appear on the screen Calibration and Verification Configuration Select Calib Verif Config in the main menu In order to add extra calibration verification steps right click on
76. tor Equipment Info 8 x e Name Location Seria GUID Incubator Microbiology INC 56 678 3DE35547 B1B0 4382 B5F2 CAFEDE 4DA 382 Oven Lab 0V34 45 12D8A333 C7FE 4848 9138 sero Autoclave FED 005 Production 2345 57830 18081772 9545 4DB1 39CC 85810B8BB711 Equipment Info IB IB JI T JE2O1 IPPBE 7314 123 12345 67890 Inectablez autoclave Click on Listing to display the report of all equipment defined ETT 1 H b admin Administrator Report Preview Form Page 1 af 1 Printed 31 05 2005 11 12 45 from Clopp B xlogq D del Autoclave FED 005 12345 67890 Equipment Production Microbiology incubator Oven a d Lab oven Incubator INC 56 678 Microbiology Injectables autoclave Close the window to return to main menu 30 User s Manual _ rev2 0 May 2005 XpertVal 3 2 6 Action Template XpertVal is based on a templates system which allows the user to define and to store the channels configuration type of study distribution or penetration steam saturation report calibration configuration virtual channels and info about equipment Enter in Templates module and click on New Highlight the channel s to be configured gt right click and Use XpertVal can accommodate up to 20 sensor inputs in any combination of thermocouples PT100 thermistors voltages or current inputs Define the type of channel Configuration
77. ure and start a new test study from the computer Once data starts being stored on the computer click on Cancel and then choose the test termination with option 1 or 2 The software will stop but the data logger will continue storing data The data will be saved on the PCMCIA card Se Test Termination 9 x 2 Terminate and Stop Hydra Terminate and Continue Hydra Scan without PC Cancel 2 Terminate and do NOT change current status of Hydra _ Lock Front Panel After Termination Option 1 Test Termination JD x 2 Terminate and Stop Hydra O Terminate and Continue Hydra Scan without PC Cancel ei Terminate and do NOT change current status of Hydra Lock Front Panel After Termination Option 2 In order to stop data logger s acquisition there are two options Connect the computer and start a post test calibration Push on SCAN button of the data logger 57 User s Manual _ rev2 0 May 2005 Read data from the PCMCIA card Data stored on the PCMCIA card is available for the user By reading data from the card inserted in the data logger By reading data from the card inserted in the computer In Test click on Import from PC Hydra to recover data from the PCMCIA card of the logger Ur Ka Els 1 0 0 6 Ho login Administrat P Equipment Verification Actions 2 Instrument FLUKE 26354 6357302 M6 9 45 02 D1 0 LB
78. urent Ww Value wi of Channel v v lt 1000 lt Curent M Value Mif of Channel v v lt M 1000 E v Enable Value Triggered Test Duration v Enable Value Triggered Test Duration v Enable Value Triggered Test Duration Current Vale wi ofChannel v lt v 1000 Curent w Vale wi of Channel v lt v 100 0 Curent Vale w themed 0 v lt 1000 SC User s Manual _ rev2 0 May 2005 all channels above or below a temperature defined by the user ofall assigned as ofall set as XpertVal Test Config Goen J va E average of Test Config e BR va JM above or below a temperature defined by the user ofall assigned as ofall setas Test Config v A V Vas j ciassinedas v Pes M Got B vae S Test Config curt Mf ve i Test Config caret B Wm WM o M wWwe e T Test Config v m M Vae vise v Pes vic Sim e Goen B vas J su Wen e User s Manual _ rev2 0 May 2005 XpertVal Enable Reset based on Temperature or F Value The Reset of the test can be programmed based on temperature value or F Value options are similar to the previous option Enable Start based on Temperature Value even for the F Value Test Config Intervals By Time By Value v Enable Value Triggered Start Of Data Collection v
79. v Y 6 00 RTD 98 800 C Expecting temp 131 0 2 0 C C Idee RTD 130 678 C Drift 0 09 C 0 44 7 1 00 s RTD 89 616 C Drift 0 02 C Calib at 90 0 16 0 56 mm ss YT v User s Manual _ rev2 0 May 2005 XpertVal Corrected data XValFL 1 0 0 6 No login Administrator Calib Calibration autoclave D xi Ch Func Assign Labe Status ur Value cur ERR Avg ERR Max ERR Actions tz ee ee WI CUM WE WR WER WI WE WA ow 02v 03V DV 05v DV 07V ogv ogy 10v 11v 12V 13V 14av 15V 18v 17V 18V 19v 20V F H e I Ty I t LL TTTT TT TT TT TT e a TTTT e eo TT 4 17 35 Sun 12 Jun 2005 t I l 1 l l T l l I l l l l I I 8 k if Paige a panes ene HESENE WESEN pana XI XI XI KI I XI KI XI XI XI x x af 8 TT be en a a 38 User s Manual _ rev2 0 May 2005 XpertVal When calibration 1s ready the calibration report will be saved in the calibration reports list Actions a l Open Double click to open ee TIRE Calibration autoclave 12 06 05 17 31 15 CDD25391 84BB 484B 98DC 2B8E 3F01 7981 XValFL 1 0 0 6 No login Administr tor Calibration Input Module XE XI XI XI XI XI XI XI XL XI I XI XI XL XI XI XI XI X s
80. y record of the 9 probes Useful for the probes calibrations in the field 269 5 User s Manual _ rev2 0 May 2005 4 4 Temperature block Type LIVES Temperature range Diameter of validation insert Standard insert depth Accuracy Stability with standard insert Homogeneity between insert s well Vertical homogeneity on 40 mm Screen and programming Temperature from ambient to max From Max to 100 C Automatically commutation test Programmable grade Auto pas Power supply Dimensions Weight Protection class Important characteristics Double heating zone for better homogeneity in the wells A very good accuracy MVI circuits assure the temperature stability independently of the source variations Double Peltier effect LTR 155 ATC 15 30 to 155 C 26 mm 150 mm 0 19 C 0 02 C 0 02 C 0 05 C LCD 23 min 3 min Yes Open 230 or 115 V 50 or 60 Hz 12 6 Kg IP 10 Double heating zone LTR 320 et 650 LCD display Complete keyboard very easy programming ATC 320 50 to 320 C 26 mm 160 mm 0 26 C 0 02 C 0 01 C 0 10 C LCD 7 min 22 min Closed 0 1 9 9 C min Yes up to 10 241 x 325 x 139 mm RS 232 communication protocol for remote control 2 63 x 10 Kg XpertVal ATC 650 50 to 650 C 26 mm 160 mm 0 39 C 0 03 C 0 05 C 0 40 C LCD 27 min 43 min Hysteresis

XpertVal - FLW of PA, Inc

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