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XpertVal - FLW of PA, Inc

1. F13 OOOO OOOO EOL OOOO OO F14 OOOO OEI OL OOO OOOO OOOO Iv 15 OOOO OOOO HEEL I AE AE OE AE EE AE E AE IL A A v 1R m From 13 06 05 19 50 530N v To 13 06 05 20 11 230FF v From 13 06 05 19 50 53 ON Y To 13 06 05 20 11 230FF v LL 13 06 05 1950530N 13 08 05 20 07 23 A 13 06 05 19 51 01 C3 13 06 05 20 07 31 13 06 43 06 05 19 51 09 a m 13 06 05 20 07 39 orr 13 06 05 20 07 47 3406 08 13 05 05 19 51 17 1 13 06 05 19 51 25 e 10 13 06 05 20 07 55 13 06 05 20 08 03 13 06 05 19 51 33 13 06 05 19 51 41 13 06 05 13 51 43 13 06 05 20 08 11 vj 13 06 05 20 08 13 uu Four options are available Statistics by interval Define the interval from to in order to calculate the Min Max Range Avg and FO for this specific interval sy Tu User s Manual _ rev5 0_Fevrier 2010 XpertVal Statistics by MKT Calculate Mean Kinetic Temperature the user has to specify the activation energy and the limit temperature The formula to calculate the MKT is AH f SERE fi K TT H AH AH e RT pe RT qee RT Where Ty Mean Kinetic Temperature in Kelvin AH the activation energy typically within 60 100 kJ x mol for solids or liquids R the gas constant T to T temperature
2. Installsmeld 14 User s Manual rev5 0 Fevrier 2010 32 XpertLog InstallShield Wizard InstallShield Wizard Completed The InstallShield Wizard has successfully installed XpertLog Click Finish to exit the wizard v Launch the program i Gancel Click on Finish to start the software enter the name and the serial number XpertVal icon is automatically placed on the desktop XpertVal Version 1 0 0 6 ny Evaluation Serial Num NA z Input serial number Company Lax Serial A Cancel _ Database not selected 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 i XpertLog InstallShield Wizard Welcome to the InstallShield Wizard for XpertLog The InstallShield R Wizard will allow you to modify repair or remove XpertLog To continue click Next i XpertLog InstallShield Wizard Remove the Program You have chosen to remove the program from your system Click Remove to remove XpertLog from your computer After removal this program will mo longer be available For use If you want to review or change any settings click Back Installshield ji XpertLog InstallSh
3. i 03 MHIL O iP 04 bt wn nnn vi wnn an vi nnani vn ant O 00 0 0 LL 05 III UAI O is PP 06 00 OO LRL O O v Time block Report End w Iz Report interval Lal Report Start METE ES 55 43 Tev M Vatios 19 55 se 13 06 05 20 04 18 Da The user can choose to only display data and trends for a part of the test not for the complete test by disabling the time blocks which are not needed e Report Intervals oo 0000000600006 IULII UU OO UU UA TII HI OO lt 01 MMM O _ 02 LITTLE TITULUM ITI UII I HDI DIL 03 l 04 A O OO DIU MIU HT ELI 05 l 0E MILII TUTTI LII LB DUAL LI Time block 13 06 05 200418 v Report interval 10 g 13 06 05 19 55 49 73406405 20 04 19 13 06 05 20 04 19 Report End ts XYalFL 1 0 0 6 john Administrator Test Report ial X r m Save Report As Input A Input Module All Assigned Report A Trend Statistics Trend Report
4. Equipment 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 XP w Windows ARP Flat Office SP Metal Raised Options Administration will define member s rights Administration Delete Tests EE m e Delete Veri and Calib Admin Delete Templates Admin ff Reporters Use Only Reviewed Templates Off E Reviewers Exportel mport Items Reporter 2 a Ef Database Create Statistics None Audit Trail Save Reports Admin Review Reports Admin Allow To Review Din Reports OFf Show Action Hints On Highlight Errors in Report Or Allow to Delete Reviewed Ite Off n Logon Required to end Calib Off Logon required to review rep On D Allow ta modify Equipment Info Off I User s Manual _ rev5 0_Fevrier 2010 XpertVal Options available delete tests double click and define the level allowed for the action A 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 items double click and define the level allowed for the action create statistics double click and define the level allowed for the action save reports double click and define the level allowed for th
5. Probe Probe LIVES Ext 6 9600 529154 03 Unit C LIVES Ext 6 9600 520688 02 Unit C Temp 20 020 C Temp 89 998 C Verification of Serial Number is Recommended e Verification of Serial Number is Recommended wv Block Block LIVES 3125 ATC 157B 6 9600 524435 00141 Unit C LIVES 3125 ATC 157B 6 9600 524435 00141 Unit C Control External 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 A Format Hydra MC requested e Proceed Hydra Scanning Fin progress will be terminated EL Proceed a XValFL 1 0 0 6 No login Administrator Equipment Actions ES Refresh Ports Verify Sa Caric l dj Hydra ed Probe l Block Mode Comm Port w Pat S modem vi Baud 3600 m Type LIVES Est v Digits 3 0001 v Click on Save to save the verified configuration cT User s Manual
6. 36 User s Manual rev5 0 Fevrier 2010 XpertVal Template view report Open the template report saved previously and click on Report to view the template report XValFL 2 0 0 0 admin Administrator Template Config Configuration Page 1 of 1 CD15E8EE 1491 4F04 A41 F EGSBBEBB 4150 Printed 01 11 2008 21 04 31 from CiProgam FilesLivesXpertVal en v2 0data base v2 0 dfl XValFL 2 0 0 0 SN 55294 13812 08121 08347 Licensed to Lives International F Config Steam Z Value 10 0 C To Temp 121 0 C Min Temp To Calc F Value 1180 C Steam Saturation Temp Chan 01 Press Chan 00 Pressure Unit bar Tolerance 0 01 Caib at 20 Temp 20 0 C Error Allowed 1 0 C Check Time 1 00 mm ss Verify at20 Temp 20 0 C Error Albwed 0 3 C Check Time 1 00 mm ss RTD Drift Allowed 0 05 C Dev From Refer Allowed 2 0 C Check Time For Daft 200 mm ss Input Module Value 0 50000 0 00 FValue 1 00000 0 01 FValue 1 00000 0 01 FValue 1 00000 0 01 FValue 1 00000 0 01 FValue 1 00000 0 01 FValue 1 00000 0 01 FValue 1 00000 0 01 FValue 1 00000 0 01 FValue 1 00000 0 01 FValue 1 00000 0 01 FValue 1 00000 0 01 1 00000 0 01 1 00000 0 01 1 00000 0 01 1 00000 0 01 1 00000 0 01 1 00000 0 01 1 00000 0 01 1 00000 0 01 1 00000 0 01 511111111111111118111 00 z01 02 03 04 05 206 07 08 z09 10 211 12 13 14 15
7. LL SS SS SS wz Se Se Se GERI I Se LI Wi I QR i otv 02v 03v 04v 05v ogv 07v 08v ogv 10V 11v 12V 13V 14V 15V 1ev 17v 18V 19V 20V Test Image 23 2 01 11 2008 21 54 02 2 23 0 22 8 N N 9 i D Uu Temperature 21 4 amp 5 5 21 47 21 48 21 49 21 50 21 51 21 52 21 53 Sat 1 Nov 2008 55 User s Manual rev5 0 Fevrier 2010 XpertVal Create image report Insert image in the test report Click on Test image then on the image icon Actions Lo lt JI NEZ 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 iz XValFL 2 0 0 0 admin Administrator Test Report ctions Actions 2 Save Report As Save Report As m 2 2 Input Module Y i Eu Associations View Report Trend Statistics Report Trer d Trend Report Saturation amp Testimage Image Report Statistics Settings F Config Saturation Config Report Intervals Assign Verif Virtual Chann Add Info Settings F Contig Saturation Contig Report Intervals Assign Yer Virtual Chann Add Info is XValFL 2 0 0 0 admin Administrator Test Report Actions Save Report As Page 1 of 1 Input Test Image Printed 01 11 2008 22 05 29 from C Program FilesiLivesU pertVal en v20 at base v2 0 dfl 2 Input Module XValFL 2 0 0 0
8. Func To T eT TeT ToT TeT TWE TWWI ET TeT WI TeT TT WT EF TeT TeT WI TT Te T Tc SetAs Value Value Value Value Value Value Value Value Value Value Value Value E Value Value Value Value Value Value FV Used Calb 1 Li 1 l 1 i 1 1 Li z1 1 1 i i Ld i sl Edi Li Li Caib Ststus OK OK OK OK OK OK OK OK OK OK OK OK OK NOK OK OK OK OK OK OK Cc M Val 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 10000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 0 B Val O10 014 03 034 073 042 035 018 060 029 0 069 054 0 020 019 025 028 002 00 yo Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg D Deg Deg Deg Deg Deg Deg Di bel 2 01 11 08 21 38 10 ON 2259 22 32 2253 2258 22 73 2250 2253 2233 22 28 22 681 2294 2239 2243 2228 POT 2243 2232 2235 2255 2243 0 01 11 08 21 38 20 2259 2235 2255 2258 2272 2252 2255 2232 2229 2261 2287 2241 2242 2230 2244 2234 23 257 2243 0 01 11 08 21 38 30 22 59 2233 2252 2257 22 70 2251 2254 2234 2235 2258 2280 2238 2242 2229 2242 22 31 2234 2256 2242 0 01 11 08 21 38 40 2259 2233 2254 2259 2272 2251 2254 2238 2225 2200 2287 2240 2240 2227 2242 22 31 2237 2258 2244 0 01 11 08 21 38 50 22 58 2232 2254 2257 2274 2251 2254 22 38 2222 2258 2288 2240 2239 2227 2244 2231 2234 258 2242 0 01 11 08 21 39 00 2258 2232 2255 2256 2271 2250 2255 2233 2218 2257 2284 2239 2239 2228 2243 22 30 2234 2257 2241 0 01 11 08 21 39 10 2255 2234 2253 2256 22 71 2
9. 16 17 18 19 20 maxval EE E User s Manual _ rev5 0_Fevrier 2010 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 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 syst
10. IMtematior XpertVal User s Manual Revision 5 0 _ February 2010 XpertVal 21 XpertVal 60 LIVES International User s Manual _ rev5 0_Fevrier 2010 XpertVal IN 3 Introduction 1 1 Introduction 1 2 Concept 1 3 Advantages XpertVal Equipment ZA Hardware equipment 2 4 Minimal Configuration of XpertVal Validation System 2 3 XpertVal Hardware Connections 2 4 Hardware configuration 2 4 1 Configuring Hydra for Comm Operations 2 4 2 Initializing the PCMCIA memory card 2 4 3 Programming the HYDRA Serial Number 2 4 4 Programming the HART module s 1502A Serial Number 2 4 5 Programming the PCMCIA communication card 2 4 6 Programming the Agilent Serial Number 2 4 7 Connecting data logger reference probe and temperature block on XpertVal software 2 4 8 Press Format MC in order to format the PMCIA card of the data logger for Hydra 2 4 9 Configure the computer to read data from the PCMCIA card Win 98 XpertVal Software 3 1 Software installation and starting diz Install XpertVal Uninstall XpertVal Start XpertVal Main Menu 3 2 1 Setup Equipment Equipment Configuration Available System Equipment Configuration Front panel lock Equipment Connections Verification Reference Probe for Calibration 3 2 2 Setup Administration 3 2 3 Setup Thermocouples Calibration and Verification Configuration Thermocouples calibration Calibration Verification Configuration 3 2
11. Input di mm yy hh mm ss SetAs 2 Input Module Used Calb All Assi M Val 1 00000 0 50000 ssigned B Val 0 01 0 00 Assign Press Label 01 11 08 21 48 24 ON 2287 0 110 s ERROR 01 11 08 21 48 33 2287 0138 6 ERROR 01 11 08 21 48 43 2287 0 078 s A ERROR 01 11 08 21 48 53 269 0 032 ERROR 01 11 08 21 47 03 2287 003 a ERROR 01 11 08 21 47 13 2287 003 1 ERROR 01 11 08 21 47 23 2 87 0 052 ERROR 01 11 08 21 47 33 2266 0 107 gt ERROR 01 11 08 21 47 43 OFF 2268 0100 hM A J Click on saturation status to display instantaneously saturation status a Steam Saturation Temperature 01 BB co Pressure 00 EA AT bar Min Expected Pressure ha bar Max Expected Pressure prem bar Saturation Status ERROR Click on Template Report to see template report s XValFL 2 0 0 0 admin As mm Oy prc nn aue Coi Page 1 Saturation Status T l CD 15EBEE 1491 4F04 A41 F E6988 88 4150 emplate Printed 01 11 2008 21 48 47 from C Program FilesiLives XpertVal_en_v20 data base v2 0 dfi XValFL 2 0 0 0 SN 55294 13612 08121 08347 Licensed to Lives Id 69673001 Module Id 1 Hydra Interval 0 10 hh mm ss Scan Rate SLOW F Config Steam Z Value 10 0 C To Temp 121 0 C Min Temp To Calc F Valuez 1180 C Steam Saturation Temp Chan 01 Press Chan 00 Pressure Unit bar Tolerance 0 01 Caib at 20 Temp 20 0 C Error Allowed 1
12. SN 55294 13812 08121 08347 Licensed to Lives International Associations Hydra Id 69873001 Module Id 1 Hydra Interval 0 10 hh mm ss Scan Rate SLOW View Report Trend Statistics Trend Report Saturation Test Image Image Report Settings F Config Saturation Contig Report Intervals Assign Verif Virtual Chann Add Info 56 User s Manual rev5 0 Fevrier 2010 XpertVal Statistics During the test the program will automatically create statistics between the beginning of the test and the first Reset between two successive Resets and between the last Reset and the end of the test By default calculations for statistics are Maximum Minimum Range Max Min Average FO After the test different calculations can be performed Open the test and click on Statistics the statistics which have already been calculated will be displayed ls XvalFL 2 0 0 0 admin Administrator Test Report BEES Actions Paper format Letter Ad 3 2 ES kJ e e pi Save Report As ad BAATDOFE 7851 472E AS8 Statistics Report Printed 01 11 2008 22 08 54 from C Program FlesiLivesXpertVal_en_v2 XValFL 2 0 0 0 SN 55294 13612 08121 08347 Licensed to Lives International Hydra Id 69873001 Module Id 1 Hydra Interval 0 10 hh mm ss Scan Rate SLOW Virtual channels max al Maxi 1 20 minval Min 1 20 delta Max 1 20 Min 1 20 did mm yy hh mm ss Func 0 10 WT
13. User s Manual _ rev5 0_Fevrier 2010 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 1s the lethality at specified conditions and can be calculated once the D value and Z value are known using the following equation F 10 Z Where To Temperature within the item being heated Ty Reference temperature Z Z value of the challenge organism For steam sterilization the values typically used are Ty 121 1 C and Z 10 C When these values are used the F value is defined as the Fo value The above equation is an exponential function and therefore as T increases there is an exponential increase in Fo Note that for Fo the instantaneous 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 B 5107 121 1 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 F D Where LR Log reduction Fo The accumulated lethality using Ty 121 1
14. C 121 amp 0 17 C 250 C User s Manual rev5 0 Fevrier 2010 XpertVal 4 2 XpertVal 60 Thermal Validation System Uncertainty XpertVal Validation system uncertainty under worst case after thermocouple calibration Data logger Agilent 34970A Conformity error A D Conversion error Compensation error Temperature coefficient Total logger uncertainty Calibration equipment Hart probe 5614 Hart display 1502 Temperature Block 155 320 Total calibration Equipment uncertainty Total XpertVal validation system uncertainty A sum of data logger and calibration equipment B cf guide AFNOR XP X 07 020 square root of the sum of squares of each uncertainty Total system uncertainty maximum is Total system uncertainty typical is 71 121 C 250 C 0 02 C 0 04 C 0 02 C 0 02 C 0 1 C 0 1 C 0 03 C 0 03 C 0 17 C 0 19 C 0 021 C 0 04 C 0 01 C 0 02 C 0 02 C 0 02 C 0 051 C 0 08 C 0 221 C 0 27 C 0 173 C 0 193 C 0 221 C 121 C amp 0 27 C 250 C 0 177C O 121 amp 0 19 C 250 C User s Manual rev5 0 Fevrier 2010 XpertVal 4 3 Temperature standard Temperature display Technical specifications Resistance Temperature range Material Hysteresis Accuracy a Dimensions Model Reference probe Temperature range Resistance range Probe Parameters Accuracy Temperature coefficient T
15. 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 zix lla AIR Steam v Dry Heat Without Depyro v Dry Heat With Depyro v Ok Z Value C 10 0 2 Value C 21 0 Z Value C 47 6 To Temp C 121 0 Tx Temp C 170 0 Tp Temp C 250 0 Min Temp To Calc F Value C 4118 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 defined 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 30 User s Manual _ rev5 0_Fevrier 2010 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 eq
16. F value 118 0 C F Ace 3T 46 18 47 20 71 16 64 19 57 21 16 25 54 22 56 20 51 74 05 21 58 Calc Duration value for Every Channel Start Condition value of Channel gt 124 0 For at least 4 scants Stop Condition value of Channel 124 0 For at least 4 scans Daniae OFS OFS OE OF 0804 08 OFT 0901 08 0904 08 mamme 09 0108 17 01 20 17 03 00 17 03 01 17 02 20 17 03 01 17 02 50 17 02 10 17 02 50 17 03 00 17 02 40 17 03 00 St 09 0408 0980408 098 0108 Oe Damus 0901 08 090408 09 01 08 O01 e dT 8 09 0108 ud 17 08 40 17 08 20 17 08 20 17 07 50 17 08 20 17 08 30 17 08 10 17 08 30 17 08 20 17 08 30 17 08 30 Duration hh mm s3 b r 0 05 20 0 05 20 0 05 30 0 05 20 0 05 30 0 06 00 0 05 40 0 05 20 0 05 50 0 05 30 58 User s Manual _ rev5 0_Fevrier 2010 XpertVal 2 In order to calculate the equilibration time you should go in New Statistics Calc Duration Single Value Define start condition as Any Value of All Assigned as gt 124 forat least x scans Define stop condition as All Value of All Assigned as gt 124 forat least x scans The value choosed for the temperature will be in fact the value of the set point for starting the sterilization interval Statistics Report Test janv 2008 cycle 4 Calib Status Interval Start 087m 1 08 16 40 00 ON End 09 01 08 18 32 40 OFF F Contig Steam 2 v
17. Process Interval Cancel lv 01 A y Cancel lv 02 Iv 03 OOOO OOOO OOOO OOOO O Iv 04 v 05 MU OOOO OOOO OOOO O Iv 06 OOOO OOOO OOOO HE IEEE EE AE OE AE LL A Iv 07 v 08 OOOO IEEE OOO OOOO OOOO OOOO OO jv 09 OOOO OO UELLE UAE AE HE AE EE IEEE AE LL A Iw 10 OOOO OOOO HEEL I EIE EAE EE IE EAE ALL A v 11 F12
18. 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 After Sales Service are few of the methods applied by LIVES International to allow XpertVal users to obtain the highest degree of comfort and confidence in 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 A Statistics after the test 2I CFR Part 11 etc Raw data is encrypted and double protected on a PCMCIA card for XpertVal 21 or in an internal m
19. 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 2 4 8 Press Format MC in order to format the PMCIA card of the data logger for Hydra If data concerning the equipment is not available check the connection to the computer 2 4 9 Configure the computer to read data from the PCMCIA card Win 98 Use Word Pad to edit Config sys from CM directory Add two more lines at the end of Config sys as follows 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 ie User s Manual rev5 0 Fevrier 2010 XpertVal 3 XpertVal Software 3 1 Software installation and starting Install XpertVal Warning 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 Af
20. together with the correction coefficients for the probe The verification of the equipment in the software allows users to be aware 1f 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 XpertVal Validation System Minimal configuration of XpertVal validation system XpertVal validation system is composed by Data Logger Hydra with PCMCIA card Data logger Agilent 34970A 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 grade quality for 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 u User s Manual rev5 0 Fevrier 2010 2 3 XpertVal Hardware Connections Temperature Block Data Logger Hydra 2635A Temperature Reference Probe Fig
21. 0 C Check Time 1 00 mm ss Verify at 20 Temp 20 0 C Error Allowed 0 3 C Check Time 1 00 mm ss RTD Drift Allowed 0 05 C Dev From Refer Allowed 2 0 C Check Time For Daft 200 mm ss Input Module Eren Gra j en T Report 2 Trend Statistics Saturation 2 Template Report 2333222333 a x 2 e m sos IAEA A id popoopopoopponoprpspsospsoso ss sSJ s REREESESSEESESESEEEEEER E Data Collect Stop the test click on right upper corner ls XValFL 2 0 0 0 admin Administrator Test Saturation report test Action Paper format Letter 24 4 j E3 q A _ _ _ __ __ eee Start 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 Hydra Agilent 7 Test Termination x az Test Termination e Terminate and Stop Hydra Terminate and Stop 349704 eu ZERARE i Terminate and Continue Hydra Scan without PL C erae de nine IC tS E C Terminate and do NOT change current status of 34970 O Terminate and do NOT change current status of Hydra L Lock Front Panel After Termination User s Manual _ rev5 0_Fevrier 2010 XpertVal There are three ways of stopping the test Stop the software and the data logger acquisition simultaneously Click on Cancel and c
22. 0 06 2 20 Tc T distrib OK 89 74 0 13 0 180 0 21 RTD 98 800 C Expecting temp 131 0 2 0 C X SSS 14 55 RTD 130 678 C Drift 0 09 C 0 44 30 RTD 89 616 C Drift 0 02 C Calib at 90 0 16 0 56 mm ss User s Manual rev5 0 Fevrier 2010 Corrected data XValFL 1 0 0 6 No login Administrator Calib Calibration autoclave Actions Q Ch Func Assign Label status Cur Value CurERR Avg ERR Max ERR Trend during calibration XValFL 1 0 0 6 No login Administrator Calib Calibration autoclave Actions 4 E n z A M NX WE EE UEM EI UND WI WI WI WE WI WE WI WES WI RL ow 02v 03v ogy os ov ory oSv ogy 10v 11v 12 13V 14av 15V 16V 47V 184 19v 20V 1354 T TT TT TTTT 4 1 TTTT TTTT Um TTT TTTT TTTT TTTT esib ari a pm mp me o me fe ee eer 7 4 Sa j nn a n lt y v iv v iv v iv iv iv iv iv iv iv v v iv iv v v v TTTT L Sd _eatib AAA AA kn eek ee 17 35 Sun 12 Jun 2005 40 XpertVal User s Manual rev5 0 Fevrier 2010 XpertVal When calibration is ready the calibration report will be saved in the calibration reports list Action 2 E Name Performed Instrument GUID 12 06 05 17 31 15 CDD25391 84BB 484B 98DC 2B8E3F017981 Open Double click to open i XVa
23. 0 54 0 20 0 19 0 25 0 26 0 02 0 07 Assgn Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Label z Interval Start 01 11 08 21 38 10 ON End 01 11 08 21 42 47 R F Config Steam Z Value 10 0 C To Temp 121 0 C Min Temp To Calc F Value 118 0 C Min 22 53 22 32 22 52 2252 22 87 2249 2253 2232 2198 2257 27 2237 2235 22 WIN 2241 2229 2232 2253 22 41 Max 22 58 2237 2281 22 80 22 74 2258 2259 2244 2235 2281 22 94 2242 22 43 22 32 BEE 2249 2235 2237 2259 22 47 Delta 0 08 005 009 008 007 007 008 012 037 004 017 005 008 0 06 008 006 005 008 0 06 Avg 22 581 22 339 22 570 22 576 22 712 22 521 22 555 22 380 22 097 22 589 22 853 22 398 22 390 22 292 MOTO 22 453 22 320 22 249 22 566 22 436 F Acc 000 000 000 000 2000 2000 000 2000 0 00 00 0 00 0 00 200 0 00 0 0 0 00 0 00 0 00 0 00 0 00 Ezi gl Data Collect User s Manual rev5 0 Fevrier 2010 XpertVal Click on Saturation to see saturation report XValFL 2 0 0 0 admin Administrator Test Saturation report test Paper format Letter Ad e 2 EI l3 E Ke gt bi Actions Reset Test Bacan F Value f BAATDOFE 7651 472E AS9A DECCD724E832 vios Saturation Report Printed 01 11 2008 21 47 54 from CAProgram FilesiLives XpertVal_en_v20 data base v2 0 4fl Saturation Status Vest iTombiot aci n reno inst EEEE Er EY oro amp oressure V
24. 035 073 041 035 017 062 029 041 01 E 30 10 08 14 41 13 421 500 0 10 013 03 0 33 O72 043 035 0 18 058 029 048 E 20 10 08 14 41 23 21 500 0 10 40 15 033 033 072 041 035 018 063 029 041 02 E 30 10 08 14 41 33 421 500 0 08 0 13 0 31 033 072 041 033 016 059 028 045 03 E 30 10 08 14 41 43 21 500 0 08 2 14 0 31 0 31 0 73 0 42 0 33 0 17 0 58 0 27 0 48 E 30 10 08 14 41 53 421 500 0 10 0 15 035 035 75 039 037 019 060 029 052 04 2 30 10 08 14 42 03 421 500 0 11 0 14 034 0 22 075 042 034 0 19 055 028 0 50 E 30 10 08 14 42 13 421 500 0 11 O12 034 034 073 042 034 020 087 028 053 05 E 30 10 08 14 42 23 21 800 0 11 0 14 0 34 0 34 073 042 038 019 062 032 048 06 2 20 10 08 14 42 33 21 500 0 11 0 14 034 034 073 042 038 020 059 0 30 0 51 E 30 10 08 14 42 43 421 500 0 09 0 14 0 34 0 4 078 042 038 020 59 020 0 47 07 2 30 10 08 14 42 53 21 500 0 09 2 14 0 32 0 32 0 73 0 40 0 34 0 17 0 62 0 32 0 48 08 Min 421 800 0 08 012 O31 O31 072 039 033 016 055 027 0 39 03 Ava 421 500 0 101 0 137 0 331 0 335 0 723 0 418 0 348 0 179 0 598 0 292 0 459 Max 421 00 0 12 O15 0 35 035 076 043 037 020 083 032 0 83 10 Verif at 20 30 10 08 14 43 17 421 500 0 01 000 003 002 004 002 001 003 0 04 002 0 08 11 30 10 08 14 43 27 21 500 0 01 0 02 0 03 0 02 0 04 0 00 0 01 0 03 0 06 0 02 0 10 30 10 08 14 43 37 421 500 0 03 002 0 03 0 02 0 06 0 00 0 01 0 01 0 04 0 02 0 08 12 30 10 08 14 43 47 21 500 0 03 0 02 0 01 0 00 0 02 0 02 0 03 0 01 0 0
25. 59 Imported to database WLI ES SERVERPAC AMALFI _ ENITLDADS dt 0198 07 09 DD 45 307 Autoclave Fede v Refrigerator Lieb F Contig Steam 2 value 10 0 C Ta Temp 121 0 C hin Temp To Calc F value 118 D C Virtual channels lutaxval taxi 201 binal h ntie10 20 Delta Maxim 205 Mind 20 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 lal xi jig Comment lix Description Description all data A dwell enlarged image Cancel 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 ta XValFL 2 0 0 0 admin Administrator Test Report i ioj x Actions Paper format Letter Ad j E Save Report As Page 1 of 1 Input Trend Report Printed 01 11 2008 21 57 57 from Guna dida 2 Input Module Test Template Saturation report test Saturation report test Associations XValFL 2 0 0 0 SN 55294 13812 08121 08247 Licensed to Lives Intemational Hydra Id 69673001 Module Id 1 Hydra Interval 0 10 hh mm ss Scan Rate SLOW View Comment temperatures only Report Trend Statistics 236 2 Trend Report Saturation 23 4 z
26. As described two types of studies are available A 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 Hydra Agilent iss Test Config El xl i Test Config nj xj v Save To Hydra Memory Card Fast Hydra Scan Rate Hydra Interval h mm ss 0 10 v 349704 Interval h mm ss 0 10 v v Save To Database 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 45 User s Manual _ rev5 0_Fevrier 2010 XpertVal WARNING Data accuracy is decreased when Fast Hydra Scan Rate option is used r Fate FAST Choe Chit Chios Chie Chir Chis Choy Chl Chil Tc T Tc T Tc T Tc T Te T Tc T Tc T Tc T Tc T emp tempi tmp tm
27. Value v 12 Te T distrib Value v 12 lea distrib Value v 13 Tc T distrib Value v 13 US distrib Value zw 14 LEX distrib Value Ar 14 Tc T distrib Value MIZ 15 Tc T distrib Value Elm 15 Te T distrib Value zw 16 Te T distrib Value zw 16 Tc T distrib Value MIZ 17 js Ti distrib Value Elm 17 Tc T distrib Value MI 18 Tc T distrib Value ar 18 Tc T distrib Value MIZ 19 Te T distrib Value Ar 19 Tc T distrib Value v 20 Te T distrib Value ar 20 Tc T 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 Input Verification Mame A Werification successfully completed Verification autoclave rea sd User s Manual rev5 0 Fevrier 2010 XpertVal Double click to open verification report sz XValFL 2 0 0 0 admin Administrator Verif 3 10 x Actions 2 e j lt al 9 E 2 2 kje bi Review Page 1o gt 149F52FB DCAF 4FF2 8750 816E442A6C Verification Report Printed 01 11 2008 21 25 22 from C Program FilesiLives XpertVal_en_v2 0idats base v2 0 XVaIFL 2 0 0 0 SN 55294 13812 08121 08347 Licensed to Lives International Hydra ld 69673001 Module ld 1 Hydra Interval 0 10 hh mm ss Scan Rate SLOW Reviewed at 22 Temp 22 5 C Error Allowed 0 5 C Check Time 1 00
28. at each of the sample points in kelvin n the number of temperature sample points 154 xl amp Interval Mir MKT Calc Duration Adv Statistics Y Calculate Mean Kinetic Temperature Activation energy 10 5 kJ mol Limit temperature 108 NE Universal constant 0 0083144 kJ mol K Statistics by duration Typically there are 2 situations where this statistics are calculated but they can of course be used for any type of application the user consider they may be suitable for 1 calculate the dwell time based on the level of the temperature measured by each logger Value for every channel 2 calculate the equilibration time in an autoclave cycle Single Value 1 First uncheck Calculate Mean Kinetic Temperature box Then click on Calc Duration and choose Value for every channel Define start condition as Value gt 124 0 for at least x scans Define stop condition as Value lt 124 0 for at least x scans x scans this will be the number of scans needed to avoid an overshoot while calculating the dwell interval Statistics Report Test janv 2008 cycle 4 Interval New Statistics z 53 09 01 08 16 40 00 ON 087017 E 09 01 08 16 40 00 ON 09 017 j Interval Start 0901 08 16 40 00 ON End 09 04 08 18 32 40 OFF F Config Steam Z value 10 0 C To Temp 121 0 C hin Temp To Calo
29. mm ss Drift Allowed 0 05 C Dev From Refer Allowed 2 0 C Check Time For Drift 200 mm ss E dd mm yy hh mm ss Te T Te T Te T Te T Te T Te T Te T Te T Te T Te T Te T TeT Te T Te T Te T Te T Te T Te T Te T Te T Set As Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Value Used Calib Calibration 1 _ Calib Status OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK M Val 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 000 B Val 0 10 0 14 033 0 34 073 042 025 018 060 029 046 069 054 0 54 020 0 19 025 028 002 0 07 Label Verif at 22 01 11 08 21 23 43 422 500 0 15 0 28 017 014 003 0 18 O17 029 044 013 005 031 032 038 008 034 038 025 013 0 28 01 11 08 21 23 53 422 500 015 038 017 014 003 O18 017 029 049 013 005 031 032 040 008 034 0238 035 013 027 01 11 08 21 24 03 422 500 0 15 0 28 O17 0 14 003 O16 O17 029 046 0 13 0 03 031 032 040 008 024 038 035 O13 0 28 01 11 08 21 24 33 322 500 014 0 38 017 0 16 003 0 17 on on B 013 0 05 0 31 033 038 008 031 040 038 03 DA 01 11 08 21 24 23 422 500 0 14 026 O17 014 003 O17 015 029 050 O13 005 033 033 035 008 033 037 JA O11 028 01 11 08 21 24 33 22 500 014 036 016 O11 005 017 014 030 MBA 012 004 030 033 037 005 033 0
30. modified or deleted the only change for the display is the interval choosed for displaying the data The user need to define the time blocks needed e g the heating time the dwell time the cooling time Define the first time block from start to the value choosed and define the interval then define the other time blocks iz Report Intervals l 215 x ad TEM IIIIII IIIIII OUOU OOU FILI IN VIT VITE NNN NIIN VOUN ITI HELL NNN NININ ll IIIIN HIE ELLE FILI LLLI VIL IT NOEL NNN OOOO VOUA DAN ll 01 es j 02 l 03 OO 0 NMP MU HABI 04 MM 00 0 OOO LULA NIHIL 05 Y N iP 06 MM IU ULT TL HL OO O O Time block n 3 06 05 19 55 49 h 13 05 05 19 55 49 13 0605 13 55 57 I 13 05 05 19 56 05 73 13 06 05 13 55 13 Report interval Nase 13 06 05 19 55 49 Report End Report Start i 13 05 05 19 55 49 13 06 05 19 56 21 13 0605 13 55 23 13 06 05 19 56 37 13 06 05 13 55 45 a Gua lol xd IL ll lll lll lll VOUA OOOO III lll lll VLL VILE HELL 800 LATI TET TI lll VLLL FELT lll NI ELI LIE ELE EET ELI EH IT VILE ELE ELE NININ EI NOOO VILE HELL WOOO NNN 1 ES 02 l
31. n n n n Hn n n Hn 1 CALIB 127 C Calib Status 0k DK ok ok oK DK 0k mal 1 00000 1 00000 1 00000 100000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 B val 0 08 0 05 0 05 0 13 D 07 0 07 0 00 0 09 0 00 0 35 0 05 Label Interval Start 09 01 08 16 40 00 ON End 09 01406 18 32 40 OFF F Config Steam Z Value 10 0 C To Temp 121 0 C Min Temp To Calc F Value 118 0 C Advanced Statistics Start 09 01 08 16 40 40 End 09 01 08 18 31 50 Temp Min min 1072 41674 C Min Average 1072 442 745 C Max max 128 1158 372 128 65 C Max Average A49 TT1 C Delta Max max Min min 111 910 C Overall Mean 44 759 C F Acc 37 46 19 47 20 71 16 64 19 57 21 76 2554 22 06 2051 Advanced Statistics Start 09 01 05 16 30 40 End 09 04 08 18 31 50 Temp h nimin aD HB 74 Mn Average STD 2 45 htax Single Point Megative Deviation 28 07 kasimas W3TI 128 65 C hax Average 41158 5 r1 hax Single Point Positive Deviation 433 88 Delta iaximax Min min 4117 910 C Overall Mean 44 759 C hist Average Negative Deviation 2 01 C bax Average Positive Deviation 4 01 C F Ae 3T 46 18 47 20 71 16 64 18 57 21 76 25 54 27 66 20 61 24 05 21 58 60 User s Manual rev5 0 Fevrier 2010 Report intervals XpertVal This feature is useful to limit the number of pages in a report displayed for printing Raw data are not
32. panel in order to control it A 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 18 User s Manual rev5 0 Fevrier 2010 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 Equipment Equipment i Equipment Lock front panel Fort 1 IM Made Comm Port v Comm Port Pork j 1 v 1 Baud 38400 Baud A 39600 v Unit Celsius v Type LIVES Ext IW ATE Digits HART DTI 81 Module 1 v LIVES Int Agilent Equipment Equipment Equipment Lock front panel Made Comm Fart v Comm Port Port 6 modern v E modern Port 1 IM Baud 3600 v i 3600 Baud 38400 v Type LIVES Egt we LIVES IB RTD Digits HART DTI 51 Li n
33. 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 the 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 tempe
34. 1 XpertVal equipment connections XpertVal Data Logger Agilent 34970A 2 EJ Im A LLL LIVES INTERNATIBNAL User s Manual _ rev5 0_Fevrier 2010 XpertVal 2 4 Hardware configuration 2 4 1 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 by using the up down arrow keys Select 38400 press Enter Un a mi LIST Baud 238400 ENTER PAR no ENTER CTS OFF ENTER Echo OFF ENTER User s Manual _ rev5 0_Fevrier 2010 XpertVal 2 4 2 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 yES will initialize the memory card erasing all p
35. 10 53 25 D Dz6 23 05 24 06 24 06 23 08 24 07 29 07 24 06 23 99 24 00 24 08 24 02 24 00 24 07 23 05 23 87 23 07 23 05 23 88 aH 23 91 23 08 23 83 23 880 M Lt Ll Compiled 130605 18 50 50 Created 13 08 05 01 03 31 by John Smith Gohrn Reviewed 1308 08 01 10 18 by Reviewer heviewer x50 User s Manual rev5 0 Fevrier 2010 XpertVal Recommendation In Administration Options Review reports choose allowed for only for Reviewer A Disable the option Allow to Review Own Reports The software will request a confirmation for reviewing the report acknowledge in order to confirm review of the report Confirmation TENE x Permanent Review Record of Report 2008 avr 06 Mew report 1 is just about to be written Proceed A new screen will pop up to ask the reviewer to reconfirm the password Confirm password Liser Name Password 63 User s Manual rev5 0 Fevrier 2010 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 Configure 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 da
36. 18 060 029 046 069 0 54 054 0120 019 025 026 0 02 0 07 Assign Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Label Reset the Test All Calculated values will Reinitialize sz XValFL 2 0 0 0 admin Administrator Test Test one channel OTC 4 E ni xi Paper format Letter Ad e A E l lk Jl s gt bi BB1C100F C492 4324 97F8 894 FC Statistics Report Printed 01 11 2008 21 42 54 from C Program FilesiLives XpertVal en v2 0 data bi Test Template Test one channel OTC Template test 1 _ 20 channels Tc XValFL 2 0 0 0 SN 55294 13812 08121 08347 Licensed to Lives International Hydra Id 69673001 Module Id 1 Hydra Interval 0 10 hh mm ss Scan Rate SLOW dd mnvyy hh mm ss Func Te T ToT Te T Te T Te T Te T Te T Te T Te T Te T TT Te T Tt Tet Te Y Te T Te T Te Y Te T Tex SetAs F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value Used Calib Calibra on 1 _ test Caib Status OK oK oK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK M Val 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 B Val 0 10 0 14 4 33 OH 073 042 035 018 0 60 029 046 0 69 0 54
37. 252 2253 2233 2218 2257 2283 2241 2238 2228 241 2230 2233 2253 2241 0 01 11 08 21 39 20 2255 2234 2255 2252 2287 2250 2253 2233 2209 2259 2277 2237 2237 2228 2243 2230 2233 2255 2243 0 4 01 11 08 21 39 30 22 54 2234 2256 2255 22 71 2249 2254 2235 2208 2258 2284 2240 2239 2227 2245 2231 2234 2256 2242 0 Rebuild Repot Ei 4 01 11 08 21 39 40 2258 22 34 2256 2257 2272 251 2254 2235 2208 2260 2288 2240 2235 2229 2248 2231 2232 2258 2242 0 4 01 11 08 21 39 50 22 58 2234 2258 2259 2272 2251 2254 2233 2210 2258 2288 2238 2235 2229 244 2229 2234 258 2242 0 00 User s Manual rev5 0 Fevrier 2010 XpertVal Click on Trend to see real time trending for all channels XValFL 1 0 0 6 No login Administrator Test Report Mon 13 Jun 2005 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 Iv v Iv d w w w Iv M w w w 5 Actions Reset Test Input Actions Reset Test A Input Module All Assigned Grid Report Trend A Statistics Template Report Filter Rebuild Report iv y 01 User s Manual rev5 0 Fevrier 2010 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 t
38. 37 024 010 0 2 01 11 08 21 24 43 422 500 0 14 036 016 013 005 019 O16 020 MOB 014 002 030 031 037 005 033 037 024 010 0 2 Min 422 500 014 036 O16 O11 003 O16 014 029 044 O12 002 020 031 035 005 031 037 034 010 0 28 Ava 422 500 0 144 0 380 0 167 0 137 0 038 0 174 0 161 0 296 0 499 0 120 0 041 0 310 0 323 0 379 0 071 0 331 0 379 0 347 0 119 0 25 Max 422 500 015 036 O17 O16 0 05 0 19 O17 O31 054 014 0 05 033 033 040 008 034 040 038 013 0 27 Status OK OK OK OK OK OK OK Ok Failed ok OK OK OK OK OK OK OK OK OK OK Performed 01 11 08 21 23 39 John Smith by admin Created 01 11 08 2125 33 John Smith by admin Reviewed 01 11 08 2128 13 John Smith by adm i rly If during the verification the value measured by the sensor was not within the specifications defined by the user those specific values will be yellow highlighted and the status of the channel will be Fail Add a comment Click on Add info for adding comments in the header of the verification report Paper format Letter 7 A4 Hydra ld GST Module ld 1 Hydra Interval 0 10 hhomm ss Scan Rate SLOW Reviewed at 22 Temp 22 5 C Error Albwed 0 5 4 6 Check Time 1 00 mm ss RTD Drift Allowed 0 05 4 0 Dev From Refer Allowed 2 0 Cy Check Time For Daft 200 mm ss s43 User s Manual rev5 0 Fevrier 2010 XpertVal 3 2 9 Action Test To start a new test go in Test New connection with data logge
39. 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 3 4 7 Action Calibration Pre Calibration Principle of calibration Performing the calibration 3 2 8 Action Verification Post Calibration 3 2 9 Action Test Test configuration Delayed Start Reset or Stop data acquisition By Time By Value Enable Start based on Temperature Value Enable Reset 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 Stop the software and do not stop data logger acquisition user may change data acquisition interval Nm ONO NI QNI N OU Rd 14 14 15 16 17 18 18 19 20 21 22 23 28 28 29 30 32 33 35 35 35 36 36 37 38 38 38 42 44 45 47 47 48 48 49 49 50 54 54 User s Manual rev5 0 Fevrier 2010 Stop the software and do not stop data logger acquisition user cannot change data acquisition interval 4 Test Report Create trend report Create image report Statistics Statistics by interval Statistics by MKT Statistics by duration Advanced Statistics Report intervals Electronic signatures Data Logger used as stand alone unit data acquisition without computer Read data from the PCMCIA
40. 5 0 03 0 00 iv iv iv iv iv iv iv iv iv iv iv iv iv iv iv iv iv iv iv Vv 13 30 10 08 14 43 57 21 500 0 01 0 00 000 002 004 000 0 01 003 010 002 02 20 10 08 14 44 07 421 500 0 01 000 003 000 002 000 00 1 0 01 004 002 0 04 14 30 10 08 14 44 17 421 500 0 01 0 04 003 002 000 002 001 0 02 004 0 01 004 30 10 08 14 44 27 421 500 0 01 0 00 003 000 001 002 003 002 003 003 006 15 30 10 08 14 44 37 21 500 0 01 0 03 0 01 0 02 0 01 0 02 0 01 0 02 0 01 0 01 0 04 16 30 10 08 14 44 47 421 500 0 01 0 02 001 000 000 000 0 01 0 01 002 001 0 02 30 10 08 14 44 57 21 500 0 01 0 03 0 01 0 02 0 01 0 01 0 01 0 02 0 03 0 01 0 03 17 18 Performed 30 10 08 14 39 48 John Smith by admin Created 19 20 X 4 P Paper format e Letter A4 mie gt pl You may choose the type of paper the report will be printed on and print the reports using the task bar above the report The reports can also be saved in 4 different formats pdf html CSV excel Error messages Three types of error messages may appear during a calibration ERR CI ERR C2 OTC orP OL or N OL The ERR C1 and ERR C2 messages means the difference between the measured value of the thermocouples versus the reference probe is not within the accepted specifications defined by the user Possible causes The thermocouple is not inserted enough in the well The thermocouple wire is not a good quality w
41. 5 14 37 46 82490300 146 43F3ECOF Eu e HEJ 2005 Apr 22 New test 1 22 04 05 12 35 32 82490300 34 OBEEDESAB of 13 05 05 New Import from PE Hydra Browse E 09 05 05 of 05 05 05 z 4 n be jer an n i 22 04 05 Mame Created SS o Reviewed Ea By Autoclave Validation 13 08 05 00 36 10 j inu E No Login G J Instrument Close the main report and open the sub report to verify data and electronically sign it If the user logged in previous to start the program his name will appear in the report at Compiled If the user didn t logged in the date only will be displayed at Compiled When saving the test the name of the user will be displayed at Created T0605 19 53 01 D 127 23 84 23 05 23 06 23 88 23 04 23 80 23 04 23 80 23 04 23 02 23 865 130605 19 53 09 D 128 23 85 23 06 23 05 23 89 23 93 23 88 23 05 23 87 23 97 23 95 23 86 150606 18 53 17 0 092 23 865 23 97 23 05 23 80 23 94 23 80 23 08 23 81 2308 23 93 23 80 TOROS 10 53 25 0 076 23 05 24 06 24 06 23 99 24 02 24 00 24 07 23 99 24 06 24 02 23 08 Compiled 1306 05 19 50 50 Created 13 0809 01 03 31 by John Smith john Rewiewed To review the report you have to be logged on as Reviewer 19 0606 19 53 08 0 129 23 55 23 96 23 05 23 88 23 07 23 97 23 88 23 87 23 890 Se 13 0605 19 53 17 0 093 23 56 23 97 23 95 23 90 24 00 23 88 23 87 23 88 23 81 23 00 23 04 23 88 Tae 139 0606
42. New test 4 ie CREER AA y e Battery Warning 30 10 08 20 26 30 Start Test John Smith admin test2 nous versune IF Cali Deleted 29 10 08 22 44 17 Audit DB created No login CRCERROR 30 10 08 21 09 10 Start Test John Smith admin 2008 oct 20 New test 5 iv Ei wy n 29 10 08 22 44 18 logon To login As Administrator st PC DE SIEMENS Calib Deleted 30 10 08 21 30 10 Start Test John Smith admin 2008 oct 30 New test 6 IZ Com ac a 29 10 08 22 45 24 Manage Members No login Member admin added Calib Warning 30 10 08 22 07 43 Start Test John Smith admin 2008 oct 30 New test 3 Vc 5 Test 29 10 08 22 45 42 Manage Members No login Member admin deleted Compact Database 34 10 08 15 42 51 Start Test John Smith admin 2008 oct 31 New test 1 B guid E No login rar O Continue Test 31 10 08 22 13 46 Start Test John Smith admin 2008 oct 31 New test 2 M Hydra Formated 29 10 08 22 46 28 Manage Members No login Member user added Hydra File Deleted 01 11 08 20 15 41 Start Test John Smith admin 20 nov 01 New test 1 M Import Test 23 10 08 22 47 34 Manage Members No login Member reporter added z eae owed EE mport Test Iv Loggers emptyed 29 10 08 22 48 02 Manage Members No login Member view added r ie sre enan d ZI Logon 29 10 08 22 50 41 Option Changed No login Login Required to use this Database option changed to True i 99 py V Logon Failure 30 10 08 11 15 00 Logon John Smith admin As Adminstrator st FC DE SIEMENS r WEDA EA
43. S V Manage Members 30 10 08 11 18 38 Report Created John Smith admin Template Template test 1 _ 20 channels Tc l Menace Memb f Report Template test 1 _20 channels To ge Members Y Option Changed Option Changed 7 Report Created 30 10 08 11 56 51 Start Test John Smith admin 2008 oct 30 New test 4 pon Gnange J Bina Daed 30 10 08 12 54 18 Reset Test John Smith admin 2008 oct 30 New test 4 7 Report Created j 30 10 08 14 38 55 Stop Test John Smith admin 20 001 20 New test 4 E Report Deleted IV Report Reviewed zs z Report Reviewed IV Reset Test 30 10 08 16 11 08 Report Created John Smith admin Calibraton Calibration 1 _ test axe P Report 2008 oct 30 New report 12 Reset Test Y Start Data Collection 30 10 08 16 36 35 Option Changed John Smith admin Allow To Review Own Reports Start Data Collection IV Start Test From Off M Stop Calib Verif TOUR Stop Calib Verif V Stop Data Collection 30 10 08 16 36 51 Report Reviewed John Smith admin Report 2008 oct 30 New report 12 Stop Data Collection Stop Test 30 10 08 18 45 30 Report Created John Smith admin Calibrston Calibration 1 _ test Stop T j Report 2008 oct 20 New report 13 top Test M Take Ownership Take Ownership 30 10 08 18 45 47 Report Reviewed John Smith admin Report 2008 oct 20 New report 13 M Template Deleted Template Deleted 7 Template Reviewed 30 10 08 18 53 32 Report Reviewed John Smith admin Report Templat
44. Saturation Template Report Test Image Image Report Settings F Config Saturation Config 2 Report Intervals Assign Verif Virtual Chan Add Info Filter New Trend Report Page Mo us M 20 FP Maxval Mial b a 19 56 19 57 19 58 19 59 20 00 20 01 20 02 20 03 20 04 Mon 13 Jun 2005 61 User s Manual rev5 0 Fevrier 2010 XpertVal Electronic signatures Save report in order to sign the test report Input Report Mame _ 1 Report Autoclave validation saved Autoclave Validation Cancel The report will be saved as a sub report of the main report 2 XValFL 1 0 0 6 No login Administrator Tests loj x Actions Bi Name 5 1 5 Cemped Instrument Seans GUID EJ New Test 13 06 05 19 50 50 53573021 155 75B6942A Been EJ 2005 May 09 New test 5 09 05 05 17 37 05 92490300 138 75E 312084 EJ 2005 May 09 New test 4 09 05 05 17 08 50 82490200 16 FF2905B8 EJ 2005 May 05 New test 3 05 05 05 21 41 18 82490300 452 496353602 Combine Test EJ 2005 May 5 bons dublin washer nol 05 05 05 19 00 44 82490200 510 BB SAO2E1 Listing EJ 2005 May 05 bons dublin washer 1 05 05 05 18 51 12 82490200 15 475E 4DE EJ 2005 May 05 bons secours washer 1 05 05 05 18 48 14 82490300 B 1557310 F98 EJ 2005 May 03 New test 2 03 05 05 15 56 55 82490200 3 DGE54BAB E 2005 May 03 New test 1 03 05 05 15 38 22 82490200 26 118448014 Z E 2005 Apr 22 New test 2 22 04 0
45. Setup Equipment Administration Calib erif Config F Value Config Action Equipment Info Verification Test Import Application First time when XpertVal starts the user will be logged on as Admin with no password required 16 User s Manual rev5 0 Fevrier 2010 3 2 Main Menu XpertVal is structured in modules for a better understanding and simplicity of use The structure of the software modules Setup Equipment Administration Calibration Verification Configuration F value configuration A Action Equipment Info Template Calibration Verification Test Import Application Help About Exit 17 XpertVal User s Manual _ rev5 0_Fevrier 2010 XpertVal 3 2 1 Setup Equipment Equipment Configuration Available Three types of connections are available Type Il e Data logger Hydra 2635A e Temperature block Lives e Reference probe Lives connected to Temperature block Lives Type lI e Data logger Hydra 2635 A e Temperature block Lives Hart e Reference probe Hart with external display Ametek DTI with external display Kaye IRTD Type III e Data logger Hydra 2635 A Oil bath Hart e 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
46. WTF TT wT RAT AT ZWE wT WE R Y Tet Tat AT AT MY AY SetAs Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Valu Used Caib W Val 0 50000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 0000 B Val 000 0 01 0 01 0 01 0 01 0 01 0 01 0 01 00 0 01 0 01 soa 0 01 0 01 a 0 01 0 01 0 01 Assign Press Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg Deg a A Interval Filter Start 01 11 08 21 48 24 ON E End 01 11 08 21 53 03 OFF Rebuild Report zal 2 F Config Steam Z Value 10 0 C To Temp 121 0 C Min Temp To Calc F Value 1180 C in 0138 2204 2223 2292 2288 23 42 2294 22 88 2255 2149 2287 2318 2173 2187 2180 2288 2222 2208 Max 0 142 2273 22 30 2298 2298 2347 2302 2298 2200 21600 2252 23 35 2177 2192 2188 2294 2229 2214 Delta 0 280 0 09 007 008 00 005 0 011 017 005 017 004 005 0 08 0 06 007 0 06 Avg 0 0037 22 6879 22204 22 957 22 942 22 448 22 989 22 942 22 816 21 589 22 895 23 288 21 753 21 902 21 842 22 910 22254 22 11 F Acc 00 00 o 00 000 0 00 0 00 0 00 00 00 V 00 000 New Statistics HEN 01 11 08 21 46 24 ON 01 117 M N 4 In order to create new statistics click on New Statistics i Statistics 3 loj xl T Interval MKT Cale Duration Adv Statistics Ok _
47. al Choose the verification mode search for calibration verification without calibration 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 li XYalFL 1 0 0 6 No login Administrator Yerification z X alFL 1 0 0 6 No login Administrator Verification Actions Verification Not Started Actions Verification Not Started Ch Func Assign Label Status 3 Ch Func Assign Label Status Start Verif Start Verif 00 0 10 Ydc Press Disabled 00 0 10 vdc Press Disabled Veri Config z n Verif Corfa v 01 Te T penetr drain Value v D1 15 1 penetr drain Value Y 2 Te T enetr Value Input a P Input Verification Configuration vel v 03 EU penetr Value Value 2 Input Module v 04 Te penetr Value amp Input verify Value esed at121 Temp 121 0 C Error Allowed 0 2 C Check Time 1 00 mm ss SSIQNE v 05 TT penetr Value All ssi RTD Value 7 06 Te T penetr Value Drift Allowed 0 10 C Dev From Refer Allowed 2 0 C Check Time For Drift 1 00 mm ss Vake Y 07 TESTI penetr Value Value v 08 Tc T penetr Value v 08 Tc T penetr value v 09 Tc T penetr Value v 09 Tey penetr Value v 10 Tc T penetr Value v 10 Tc T penetr Value v 11 Tc T distrib Value v 11 ica distrib
48. alue 10 0 C To Temp 121 0 C Min Temp Ta Cale F value 4118 0 C F ec ar d 19 47 20 71 16 64 19 57 21 16 25 54 22 66 20 51 24 05 21 59 Calc Duration Single value Start Condition ny value of Al Assigned as gt 124 For at least 4 scans Stop Condition Al values of Assigned as 124 E 4 From 0904 08 17 01 20 To 09 01 05 17 03 00 Duration 1 40 hh mm z2 Advanced Statistics In order to calculate advanced statistics you should go in New Statistics switch Calc Duration on Not Used then click on Adv Statistics and check Process Advanced Statistics box The advanced statistics will be calculated for the interval choosed by the user The advanced statistics which will be calculated are Overall minimum Minimum value of all the minimum values Overall maximum Maximum value of all the maximum values Min average minimum value of all the averages Max average maximum value of all the averages Overall mean average value of all the averages Max single point negative deviation from overall mean difference between the minimum value of all the minimum values and the average value of all the averages Max single point positive deviation from overall mean difference between the maximum value of all the maximum values and the average value of all the averages Max average negative deviation from overall mean difference between minimum value of all the averages an
49. bration Configuration Calib A at 90 Temp 90 0 C 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 erihy at 121 Temp 121 0 C Error Allowed 0 2 j C Check Time 1 00 mm ss Drift Allowed 0 10 C Dev From Refer Allowed 2 0 C Check Time For Drift 1 00 mm ss g lt lt g lt i lt lt Input Calibration M ame Calibration autoclawel TH After calibration started the software will first check the drift when the drift is within the specifications the software will start thermocouple calibration XValFL 1 0 0 6 No login Administrator Calib Calibration autoclave Assign v 1 TGT penetr 1 17 RTD 89 711 C Drift 0 01 C 0 05 1 00 v 02 Te T penetr v 03 TET penetr v 04 Te T penetr v 05 Tc T penetr v 06 Tc T penetr v 07 Te T penetr v 08 TET penetr MM 9 Tey penetr M 10 TET penetr ly v 11 Ten distrib ly R A 5 v 12 Tc T distrib OK 89 70 0 09 0 143 0 18 Once the first step was accomplished the software will SL DNE E BER EE EC E ba E v 15 Tc T distrib OK 89 70 0 09 0 130 0 16 automatically switch the block to next set point E A E ES a um v 17 Tc T distrib OK 89 76 0 15 0 197 0 23 Y 18 Tc T distrib OK 89 63 0 02 0 057 0 08 v 19 Te T distrib OK 89 55 0 06 0 027
50. card 3 2 10 Action Import Export Import a report Export Import 3 2 41 Application Help 3 2 12 Application About 3 2 13 Application Exit XpertVal Technical Specifications 4 1 XpertVal 21 Thermal Validation System Uncertainty 4 2 XpertVal 60 Thermal Validation System Uncertainty 4 3 Temperature standard 4 4 Temperature block XpertVal 54 55 55 56 57 57 58 58 59 61 62 64 65 67 67 67 67 68 69 69 70 70 71 72 73 User s Manual _ rev5 0_Fevrier 2010 XpertVal 1 Introduction 1 1 Introduction XpertVal 1s 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 device EN 285 EN 554 manufacturing plants Two types of systems are available based on the type of data logger used XpertVal 21 XpertVal 60 XpertVal 21 is based on a Fluke 2635A data logger which has the ability to handle 21 channels one 20 channels module and 1 external channel XpertVal 60 is based on an Agilent 34970A data logger which has the ability to handle simultaneously up to 60 channels three 20 channels modules
51. d XValFL 1 0 1 27 SN 5573539 parted from Hydra ID 733 03 47 08 10102 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 does not apply to Agilent data logger 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 NwindowsNsystemNcsmapper sys device c windows system carddrv exe slot n where n number of PCMCIA slots 66 User s Manual rev5 0 Fevrier 2010 XpertVal 3 2 10 Action Import Export Import a report Export In order to export a report template calibration verification or test user has to right click on the report to be exported choose Export then define the location and name the report amp Export Test 2005 ao t 13 New test B 2005 a06t 13 Mew test B Export to 2005 aott 13 Mew test 7 C AXValF_O 6 new test_export dfel Open EN 2005 ao t 13 New test E E Mew Actions Combine Test 200 Listing 200 Delete E Browse Linked Objects Print All Reports iv 3 2005 ao t 13 Ne
52. d the average value of all the averages Max average positive deviation from overall mean difference between maximum value of all the averages and the average value of all the averages Range overall maximum overall minimum difference between the maximum value of all the maximum values and the minimum value of all the minimum values 59 User s Manual rev5 0 Fevrier 2010 XpertVal E lc xj Calculated statistics Overall Minimum Min of Minima B Overall Maximum Max of Maxima C Min Average Min of Averages D Max Average Max of Averages E Overall Mean Avg of Averages A E Max Single Point Negative Deviation from Overall Mean B E Max Single Point Positive Deviation from Overall Mean C E Max Average Negative Deviation from Overall Mean D E Max Average Positive Deviation from Overall Mean B 4 Range Overall Maximum Overall Minimum 2567 AD25 4F Statistics Report Printed 04 02 2008 02 22 07 from C Program FilesWives Test janv 2008 cycle 4 XLog 10 1 24 SN 86616 85380 13105 03333 Licensed to Sanofi Aventis Date amp Time Action 372 429 437 785 1072 1074 1158 1320 1576 1577 ddimm yy hh mm ss Func Temp C Temp C Temp C Temp C Temp C Temp C Temp C Temp C Temp C Temp C Temp C Set As F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value Used Calib n
53. e action review reports double click and define the level allowed for the action allow to 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 allow to delete reviewed items enable or disable the option logon required to end calib verif test and reset test enable or disable the option logon required to review report enable or disable the option allow to modify Equipment Info enable or disable the option j Review Reports 5 xl Allowed for Reporter Reviewer Default Use only reviewed templates once a template has been reviewed the user will be able to use it otherwise the template which has not been reviewed will not be available when the user wants to start a new calibration or test Allow to Review Own Reports if the Admin ran a test he saved this test then he ll not be able to review this report his own report if this option is enabled Show Action Hints this option will show action hints Highlight Errors in Report any error in the calibration test or verification reports will be highlighted in yellow Allow to Delete Reviewed Items is an item was reviewed user can still delete it if the option is enabled Logon Required to End Calib Verif Test and Reset Test a running cal test or verif will be stopped only by entering the password 1f this option is enabled Logon Required to Re
54. e test 1 20 channels Tc Ei force Reviewed V Test Deleted 30 10 08 20 26 30 Start Test John Smith admin test 2 nous versune T Test Deleted M Test FConf Chang rela are ian tite er m vein TestFConf Chang Iv Verif Deleted 30 10 08 20 30 55 Reset Test John Smith admin test2 noua versune r Vert Deleted 30 10 08 20 49 21 Stop Test John Smith admin test2 noua versune 30 10 08 21 08 42 Logon John Smith admin As Administrator at FC DE SIEMENS 30 10 08 21 09 10 Start Test John Smithladmin 2008 oct 20 New test 5 oft 96 Az User s Manual rev5 0 Fevrier 2010 XpertVal Auto name format The default name for test or calibrations reports is suggested automatically by the software Report Options This option will allow the user to print signatures on all pages or only on the first page Administration Reporters ES Reviewers i E Database Audit Trail E amp amp Report E Vent repart options Der User s Manual _ rev5 0_Fevrier 2010 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 x XpertVal allows us
55. elp About Exit 67 User s Manual rev5 0 Fevrier 2010 XpertVal The import window will display the items belonging to the report to be imported Enable the items and click on Import then close the window the imported report will be displayed in the test report list The red T signifies the report was imported Import C 4XValHp 0 6 sexport test dhe 1 XValHP 1 0 0 6 No login Administrator Tests 133 2005 ao t 13 New test B Iv E 2005 ao t 13 New template 2 5 aat 13 New test 6 3 2 11 Application Help Click on Help to get the software manual XValHP 1 0 0 6 No login Administrator Application Calculatable Channels Help entry BH Calculatable Channels 1 Keywords not case sensitive are 0 FInst FA cc Min Max Sum Avg E Supervisor Options bl O Veye Manage users using windows authenti Logger Icons Hint 2 Calculatable Channel must have unique name identifier preferably 8 characters long due to report column width limitatior name must start with alpha character and not contain spaces When the name is enclosed in double quotes then it can contain any character including space 3 Multiple Channel definitions can be present seperated by 4 Calculatable Channel can be part of the template can be added during test assembly Xlog ot can be added
56. em 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 if the drift exceeds the limit the check time will restart The system stability is 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 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
57. emory for XpertVal 60 and for both systems in a file on the hard disk of the computer The system meets European and American requirements concerning thermal validation processes electronic data protection and data signature ey User s Manual _ rev5 0_Fevrier 2010 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 to meet current thermal validation needs and regulations XpertVal 21 can accommodate up to 20 sensor inputs XpertVal 60 can accommodate up to 60 channels simultaneously in any combination of thermocouples PT100 thermistors voltages or current inputs Sensor input is accomplished through one or three Input Module s a modular sensor input interface that protects the electronics against dust humidity electrical noise and mechanical shock One 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 2634A or Agilent 34970A to temperature standards or reference baths Lives or Hart This modular design allows for fully automatic sensor calibration as well as multiple calibration
58. emperature resolution Resistance resolution Calibration Display Dimensions Weight Type SOFTWARE 100 ohm nominal 0 1 ohm to 0 C 200 to 500 C inconel lt 0 01 C to 0 C with extremely points 183and 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 25 dia x 12 0 635 x 30 48 cm HART 200 to 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 A Display up to 9 reference probes in the same time HART probe or intelligent probe IRTD Trace the report under EXCEL with the continuously record of the 9 probes Useful for the probes calibrations in the field aD User s Manual _ rev5 0_Fevrier 2010 XpertVal 4 4 Temperature block LIVES ATC 125 ATC 140 ATC 156 ATC 320 ATC 650 Fast calibration due to special design of the block and no use of liq
59. en UNE vake TET temp Value F Config TET temp Value Saturation Config Te T temp Value Test Config ey temp Value Virtual Chan Tc T temp Value Add Info Tc T temp Value TC T temp Value T TET temp Value 2 Input Module Le All Assigned temp z temp temp temp temp temp temp temp temp temp F Value configuration Actions Start Test Input aad Salvation Config FValue Configuration Steam Z Value 10 0 C To Temp 121 0 C Min Temp To Calc F Value 118 0 C Template Report Saturation configuration Actions Start Test Has F Config Steam Saturation Temp Chan 03 Actions P Chan 00 e Pressure Unit bar Test configuration Tolerance 0 01 y Start Test X lt l Reset Test F Config xl xl Saturation Config xl xl xl Virtual channel configuration IESUS Test Configuration Scan Interval h mm ss 0 10 Save To Database Yes Save To Hydra MC Yes Fast Hydra Scan Rate Mo Virtual Chann Config i E maxvalemax im z0 minval min 1201 20 delta max 501 20 min 201 207 Start Data Collection Conditions Mot Set Data Collection will start Immediately Reset Data Conditions Mot Set 44 Stop Test Conditions Not Set User s Manual _ rev5 0_Fevrier 2010 XpertVal If you need to modify anything in the configuration you can make 1t now otherwise click on Start to start the test
60. en 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 2 4 5 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 provided 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 2 4 6 Programming the Agilent Serial Number In order to use the Agilent with the XpertVal software the Serial Number of the Agilent must be programmed into nonvolatile EEPROM of the instrument Note that the serial number is not programmed prior to shipment from the factory In order to program the serial number into the Agilent EEPROM the Terminal Program HyperTerminal RS 232 should be used to establish PC HYDRA communication Turn on the Agilent data logger 34970A Click on Shift then Sto Rcl button the display will show GPIB 488 Turn the knob to the right until the display is RS 232 then click on Sto Rcl button again The display will show 57600 Baud Using the know change the baud rate to 38400 then push the Sto Rcl butto
61. er 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 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 gt The calibration can be performed either in single point two point or multiple unlimited points mode o 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 if the drift exceeds the limit the check time will restart The system stability is 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 calibratio
62. esLivespertVal en w20wata base v2 0 dfl Close the window to return to main menu 32 User s Manual rev5 0 Fevrier 2010 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 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 THUS 100 00 RIJ D girj snunt Resistor 13 Ohms shunt Resistor Range Y Range L IU np M n np Max dut Min Wut May M Val 0 50000 3i M Val B Val Ee 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 penetratiorl Los Cancel 33 User s Manual rev5 0 Fevrier 2010 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
63. for distribution Hydra ls X WalFL 1 0 0 6 No login Administrator Template Config Actions 1 Mew template Ch Func Assignment Label Cal Allowed Input Output M val 00 O 10 dce Press No 0 10 0 5 0 50000 01 Tico Tr penetr drain Yes 1 00000 noz Tr T penetr Yes 1 00000 03 Tc T penetr es 1 00000 Steam Saturation 4 Te T penetr Yes 1 00000 Lalib Contig 5 ToT penetr Yes 1 00000 Virtual Chann 96 Te T penetr Yes 1 00000 Add Info S OF ToT penetr Yes 1 00000 o ToT penetr Yes 1 00000 na Tc T penetr Yes 1 00000 XL Input Module 2140 TeT penetr Yes 1 00000 All Assigned 11 Te T distrib Yes 1 00000 Z 12 Te T distrib Yes 1 00000 13 Tc T distrib Yes 1 00000 14 Te T distrib Yes 1 00000 15 Tc T distrib Yes 1 00000 16 Tc T distrib Yes 1 00000 17 Te T distrib Yes 1 00000 18 Te T distrib Yes 1 00000 19 Tc T distrib Yes 1 00000 20 Te T distrib Yes 1 00000 Save Configuration F Config Input A Po r3 Po r3 r PP PP PP r3 r3 r3 r3 r3 r3 Pc Agilent i XValHP 1 0 0 6 No login Administrator Template Config Actions New template Func Assignment Label Cal Allowed Input Output M val 0 10 dc Press No 0 10 0 5 0 50000 Configuration Tc T penet Yes 1 00000 TET penet Yes 1 00000 E penet Yes 1 00000 F Config Tc T penet Yes 1 00000 Steam Saturation Tc T penet Yes 1 00000 Calib Config Tc T penet Yes 1 00000 Virtual Chann
64. he 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 is to clearly define an interval inside which the users need to make the specifics calculations The data logger will automatically calculate Between the Start and the first Reset Between two successive Resets A 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 A 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 A 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
65. hoose the Terminate and Stop Hydra option Agilent Hvdra a Test Termination fis Test Termination O x Terminate and Stop Hydra Terminate and Continue Hydra Scan without PC Cancel Terminate and do NOT change current status of Hydra 8 Terminate and Stop 349704 C Terminate and Continue 349704 Scan without PC 2 Terminate and do NOT change current status of 34370 _ 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 az Test Termination lolx fats Test Termination Bl x Teminate and Stop Hydra 8 Terminate and Continue Hydra Scan without PC E Cancel 0 Terminate and do NOT change current status of Hydra Hydra interval hh mm ss 0 70 Test Time Capacity of M 09 37 hh mm Lack Front Panel After Termination 2 Test Termination 210 xl 2 Terminate and Stop 349704 8 Terminate and Continue 349704 Scan without PC a Cancel 2 Terminate and do NOT change current status of 34970 The user can modify the interval of data acquisition by using 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 no
66. ield Wizard Program Maintenance Modify repair or remove the program C Modify Change which program Features are installed This option displays the 158 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 E Remove XpertLog from your computer InstallShield lt Back Cancel ja XpertLog InstallShield Wizard InstallShield Wizard Completed The InstallShield Wizard has successfully uninstalled XpertLog Click Finish to exit the wizard i Cancel In order to completely uninstall the software the user needs to delete XpertVal folder from where it was installed 15 User s Manual rev5 0 Fevrier 2010 XpertVal Start XpertVal Version 1 0 0 6 Comprar E valuation Serial Mum Settings database C xvalFl O xsxisLog3z edd Following problems detected Settings Database nok Found Settings Database ERC Error Press Ok Eo continue Database not selected Bk Supervisor Options Define a new data base a new audit trail will be generated automatically l 1 Database C AXValFl D xxxM del created 1 Audit file required For db C VsValFl D xxxVM dxl not Found 7 Mew audit File created and audit trail has been activated XpertVal starts gt XLog 1 0 0 6 No login Administrator
67. 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 _ rev5 0_Fevrier 2010 XpertVal 2 4 4 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 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 2 1 Flow control none then File Properties Parameters gt 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 Check the serial number displayed on the screen with the serial number physically labeled on the module If the serial number displayed is only the last three digits or it doesn t corresponds with the serial number physically labeled on the module th
68. il Celsius LIVES Int Data Logger Temperature Reference Temperature block Lock front panel option Define Define Define Communication mode Communication mode Communication port Communication port Communication port Communication speed baud rate Communication speed baud rate Communication speed baud rate Temperature standard used Temperature block used Module number up to 10 0 9 IRTD Lives XpertVal remembers each module Hart Hart calibration Jofra Lives internal probe control Lives external probe control 19 User s Manual _ rev5 0_Fevrier 2010 XpertVal Front panel lock In the data logger configuration there 1s a function called lock front panel 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 disab
69. ill enter this tolerance based on internal SOP a Steam Saturation cro EA v Enable Steam Saturation Temperature Chan 01 temp R Pressure Chan 00 Press N Pressure Unit bar B 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 gt 2 35 User s Manual rev5 0 Fevrier 2010 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 Maxval max 001 20 MinVal min 10 20 Delta max 01 20 min 01 20 Virtual Channels The test report will automatically have three Mem 1020 extra channels MaxVal MinVal and Delta Delta max 01 20 min 01 20 It is recommended not to enter the virtual channels formula in the template but in the reports when needed XYalFL 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 Template for autoclave
70. ire and will not match 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 User s Manual rev5 0 Fevrier 2010 XpertVal 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 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 The equipment connected to the computer will be verified click Ok to proceed PE Verification mode Oj xj e Search for Calibration LL R duire Verification w o Calibration gt ancel Name 5 5 5 ete x Calibration autoclave 12 06 05 17 31 15 a Equipment Verification Instrument FLUKE 26354 6357302 M6 9 45 02 D1 0 L0 8 1 38400 53573021 Unit C 2B XX PC Instrument Time 18 24 26 12 juin 05 Instrument PC Time Synchro will be performed when required Memory Card is OK Size 256 K Free 238 K Num Of Files 1 Y 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 Extern
71. lFL 2 0 0 0 admin Adminis ator Calibration N p inl x Paper format Letter A4 8 pA E 9 f EE Kie gt p1 Save Report As Input A amp Input Module Associations ibration Report Printed 01 11 2008 21 0 tion Template Calibration 1 _ test Template test 1 _ 20 channels Tc fM alFL 2 0 0 0 SN 55294 13612 08121 08347 Licensed to Lives International dra Id 69873001 Module Id 1 Hydra Interval 0 10 hh mm ss Scan Rate SLOW 3120 Temp 21 5 C Error Allowed 1 0 C Check Time 3 00 mm ss Merif at 20 Temp 21 5 C Error Allowed 0 3 C Check Time 3 00 mm ss RTD Drift Allowed 0 05 C Dev From Refer Allowed 2 0 C Check Time For Dift 200 mm ss Action __Date amp Time Probe so 02 s sos sos soc sov sos 9 10 an Func dd mm yy hh mm ss RT WE A TST TWT eh WT ET TAO ae eT Set As Trend Report Assign Verif Value Value Value Value Value Value Value Value Value Value Value Settings Label n 3 R a 3 5 E Add Info Calib at20 30 10 08 14 39 53 421 500 0 12 0 13 0 33 035 072 043 035 018 20 029 043 30 10 08 14 40 03 21 500 0 12 0 13 035 035 072 043 035 018 060 029 039 Filter 30 10 08 14 40 13 421 500 0 10 0 12 033 035 073 042 035 0 19 060 029 040 30 10 08 14 40 23 21 500 0 10 1 0 33 033 073 042 035 019 262 031 044 Rebuild Report Li 30 10 08 14 40 33 421 500 0 10 015 033
72. led at the end of thermocouple calibration and or at the end of the test In this configuration keyboard locked 1f 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 30400 Celsius 2 O02 amp Equipment Verification User s Manual rev5 0 Fevrier 2010 XpertVal Equipment Connections Verification After the configuration is done click on Verify A dialog box will display the connection status between the data logger the temperature standard the temperature block and the computer Hydra 2635A Agilent 34970A Equipment Verification Instrument Instrument FLUKE 26354 6357302 M6 9 45 02 D1 0 L0 8 1 38400 63573021 Unit C 349704 0 13 2 2 1 38400 MY44006051 Unit C 26 PC Instrument Time 13 54 02 12 juin 05 Slot 100 349014 LIWES_01 Instrument PC Time Synchro will be performed when required Slot 200 N N Memory Card is OK Size 512 K Free 462 K Num Of Files 3 Y Slot 300 N A N Y 349704 PC Instrument Time 20 43 38 13 ao t 05
73. n Administrator Audit Actions Paper format Letter A4 8 2 E 8 2 Je bi Rebuild Repat Iv Audit OFF Iv Audit ON EJ Select All Unselect All Only start test option activated Actions Close Report Vie se Report View Close Report View Filter Audit Report d Progam i po Printed 01 11 2008 20 51 13 from CAProgram FilesiLives XpertValen_v2 0 data base v2 0 dfa Filter Audit Report a R inr on 01 52 32 from CA ves en v v2 0dfa Flabul l Ano Events shown Audit ON Audit OFF CRC ERROR Logon Failure Logon Reset Test Start Test Stop Test Stop Rebuild Report Bubs Start Test Audit DB created e Calib V erif Start Data Collection Stop Data Collection Import Test Continue Test Loggers emptyed Take Ownership mum iir ceme V Audit OFF Option Changed Manage Members Test FConf Changed Audit DB created Audit Warning Report Created Report EZECH T 2 Aud ON Reviewed Test Deleted Verif Deleted Calib Deleted Template Deleted Report Deleted Template Reviewed Compact Audit OFF zz 7 Re m Re h er aa Database Calib Warning Battery Warning Hydra File Deleted Hydra Formated Audi ON 29 10 08 22 44 17 Audit DB created No login A Bate W g n HK s xn Audit Waming 30 10 08 11 56 51 Start Test John Smith admin 2008 oct 30
74. n The display will show None 8 Bits push the Sto Rcl button The display will show Flow Xon Xoff push the Sto Rcl button Start a new HyperTerminal session Comm 1 Bauds 38400 Data 8 Parity 2 None Stop bit 2 1 Flow control 2 none then File Properties Parameters ASCII setup gt check the 2 upper boxes in the window send EOF and echo the characters To check if the serial number has been previously programmed type at the terminal prompt CAL STR If the response looks like below FACTORY CAL dd mmm yyyy 24 4C where dd mmm yyyy z date and time of factory calibration and 24 4C is the current temperature this means the serial number is not entered User s Manual _ rev5 0_Fevrier 2010 XpertVal Procedure to program the serial number for Agilent e Enable programming of the logger CAL SEC STAT OFF HP034970 then type CAL SEC STAT Terminal should respond with 0 e Check communication type CAL STR Response should be FACTORY CAL dd mmm yyyy 24 4C e Enter the serial number type CAL STR xxyyyyyyyy FACTORY CAL dd mmm yyyy Warning use single quotation mark use capitals A pay attention when typing respect the exact configuration showed above xxyyyyyyyy string of 10 characters representing the serial number of the data logger The serial number has been stored in the data logger e Verify if the serial was stored in the logger
75. n 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 28 User s Manual rev5 0 Fevrier 2010 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 Calibration or Verification in the Calibration Config window then Add Setup Equipment Administration Calib Verif Config F Value Config Verification ww at 90 0 RTD amp Block Cancel Action Equipment Info Calibration Verification Test Import Calibration E RTD amp Block i D marrer 3 S D 13 Xpertlog TR Microsoft Word Manual XL og 1 0 0 6 al LO EATA 18 08 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
76. ned 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 xValFL 1 0 0 6 ES xj Start Time in the past s47 User s Manual rev5 0 Fevrier 2010 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 is 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 E ome vae O o E Mis S M o wc wim je Caen N va I sme o O S aer va sta M o M pmo TS Cara JO vae Mi CO E 48 User s Manual rev5 0 Fevrier 2010 XpertVal Enable Reset based on Temperature or F Value The Reset of the test can be programmed based on temperature value or F Value opti
77. ol operation Pyramidal 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 calibration Specific and an individual data base for each equipment type Security and access levels programmable by the system administrator A 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 Data values and F values Trends reports Image reports Statistics Minimum values for each channel Maximum values for each channel Range Max Min Average values for each channel FO 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 Hydra 20 temperature channels and 1 channel for an external transducer pressure humidity etc Agilent 34970A up to 60 channels 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 A E
78. ons are similar to the previous option Enable Start based on Temperature Value even for the F Value Test Config Av jw vae loread Pes vl lt iio mcer rur E 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 Test Config 49 User s Manual rev5 0 Fevrier 2010 XpertVal Start Test In test configuration disable all options By Time and By Value define interval 10 sec and start test New Test Values will be real time displayed on screen for all channels as defined in the template XYalFL 1 0 0 6 No login Administrator Test New Test If thermocouples are defective rr the wires are cut the message ERR OTC will be displayed on the line corke ding to this wire Click on Report to visualize the intermediary report XValFL 2 0 0 0 admin Administrator Test Test one channel OTC COR Test Data Report Printed 01 11 2008 21 40 02 from C Program FilesiLivesXpertVal en_v20 data bz XValFL 2 0 0 0 SN 55294 13612 08121 08347 Licensed to Lives International Hydra Id 69873001 Module Id 1 Hydra Interval 0 10 hh mm ss Scan Rate SLOW F Config Steam Z Value 10 0 C To Temp 121 0 C Min Temp To Calc F Value 1180 C
79. or test equipment configurations XpertVal software is designed to run on Windows 95 98 2000 NT or XP and provides everything needed to perform validation testing While using XpertVal software the 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 2635A controlled by XpertVal 21 has up to 2 MB of PCMCIA memory and 100 scans buffer internal memory Data logger Agilent 34970A controlled by XpertVal 60 has an internal memory to store data during the test 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
80. pt tmp tmp tmp tmp t Vale Vale Vale Vale Vale Vale Vole File F tu Hn tu tu Hn Hn Hn tu 10 10 10 10 10 10 10 10 001 001 001 001 001 001 001 001 Dez Dez Leg Dez Deg 3 Ta Tx uH T 3 T3 T TX 2 1 T Td T d T 2 1 2 1 ERA T4 T 3 TE 2150 23 E TX T3 Tal E ode x Hydra scan rate used FAST Tc T Tr T Tc T Tc T Tc T Tc T Tc T Tc T tmpt tmp tmpt tmpt tmpt tmpt tmpt tmpt 0 01 0 01 0 01 001 0 01 0 01 0 01 0 01 Leg Leg Leg Leg Leg Leg Leg Leg HK 21 10 32172 HILA 21 HILA HLS HLE x HL HIR 421558 HILA Tl 2L X152 HILH HILS 21 HiL HEB 42D 21562 HIL HLS HALY 21 10 O 421759 H104 HIL 10 ALA HLS 2161 421759 421505 2175 421601 215 HILS 2161 HILT 2163 HLT HILS HLS HILS 11 1 0 dla 42155 HILS Ota 213 Hydra scan rate used SLOW 46 User s Manual rev5 0 Fevrier 2010 XpertVal Delayed Start Reset or Stop data acquisition By Time Data acquisition can be configured by the user for delayed start reset or stop liz Test Config m c xj Intervals By Time By Value v Enable Time Triggered Start Of Data Collection Reset even if Data Collection Already Started A Start Time Today hh 23 v mm 11 Enable Time Triggered Data Reset Reset Time Today v hh 23 mim 11 2v End Time Today hh 23 v mm 11 Automatic start of data acquisition data acquisition will start at a moment defi
81. r will be verified before starting the test Hydra Agilent i Equipment Verification amp Equipment Verification Instrument Instrument FLUKE 26354 6357302 M6 9 45 02 D1 0 L0 8 1 38400 63573021 Unit C 349704 0 13 2 2 1 38400 MY44006051 Unit C Slot 100 349014 LIVES_01 26 lt PC Instrument Time 22 51 11 12 juin 05 Ha Ok Memory Card is OK Size 256 K Free 238 K Num Of Files 1 Slot 200 N N v Slot 300 N A N A v 349704 PC Instrument Time 20 49 41 13 ao t 05 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 1 1 a 2 bi Start new test using option clear Hydra and search for calibration UA Software will automatically display the calibration Clear Hydra and Search for Cation reports available for the report Clear Hydra and Test w o Calibration C Upload Config From Hydra And Continue Test by default the last one 1s highlighted choose one and click Ok Created 2005 ao t 12 New calib 18 12 08 05 23 01 49 Calibration 12 08 05 22 57 58 The configuration screen will appear Double check the configuration by default the configuration iz XValFL 1 0 0 6 No login Administrator Test Actions Func Assign Label Status as described in the template used for calibration will be used Stat T
82. rature 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 38 User s Manual rev5 0 Fevrier 2010 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 T a Equipment Verification Coon Instrument FLUKE 26354 6357302 M6 9 45 02 D1 0 L0 8 138400 63573021 Unit C 2E XX PC Instrument Time 16 00 42 12 juin 05 Instrument PC Time Synchro will be performed when required qe Memory Card is OK Size 256 K Free 247 K Num Of Files Cancel Format MC Probe LIVES Ext 6 9600 529154 03 Unit C Temp 89 965 C Verification of Serial Number is Recommended qe Choose the template to be used Double check the calibration configuration drag the mouse Block to Calibration configuration and don t click on 1t The info bull Ld DA cid with calibration configuration will be displayed on screen MIE Created nnn Template for autoclave 12 06 05 15 46 51 E Template for freeze dryer 12 06 05 16 05 11 Cancel laz XValFL 1 0 0 6 No login Administrator Calibration Actions A Calibration Not Started Ch unc sign Cur Value Cur ERR Start Calib Calib Config 5 Cali
83. 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 a XValFL 2 0 0 0 admin Administrator Test Test one channel OTC E ini xi Paper format Letter Ad amp A EI 8 E lk Jl i T BB1C100F C492 4324 97F8 694 F0 Statistics Report Printed 01 11 2008 21 41 18 from C Progem FilesLivesWpertVal en_v20dats bz Test Template Test one channel OTC Template test 1 _ 20 channels Tc XValFL 2 0 0 0 SN 55294 13812 08121 08347 Licensed to Lives Intemational Hydra Id 69673001 Module Id 1 Hydra Interval 0 10 hh mm ss Scan Rate SLOW di mm yy hh mm ss Func Te T Te T Te T Te T Te T Te T Te T TeT Te T Te T Te T Te T TeT Te T Te T Te T Te T Tc T Te T Te T 2 Input Module SetAs F Value F Value F Value F Vslue F Value F Value F Vslue F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value F Value MERI Used Calib Calibraton 1 _ test E signet Caib Status OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK OK E M Val 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 1 00000 Confirmation xj B Val O10 014 033 034 O73 042 035 O
84. rev5 0 Fevrier 2010 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 requirement 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 Administration 3 Equipment RS Options Use External Probe LIVES block control if available E C Members IS Admins Style Windows XP Y j Users m 8 Reporters i Reviewers E Database _ Always Lock Front Panel in Test E Audit Trail AA Saturation Table _ Scan Interval Fixed to 2 Auto Name Format i ees Report me Verf 7 pr Mode he OTa Reference probe User s Manual rev5 0 Fevrier 2010 XpertVal 3 2 2 Setup Administration DO XLog 1 0 0 6 sorin Administrator Administration Administration WindowsXP v xP v
85. revious 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 VLA for initializing the card 2 4 3 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 programmed 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 2 None Stop bit 2 1 Flow control 2 none then File Properties Parameters ASCII setup gt check the 2 upper boxes in the window send EOF and echo 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
86. s Yes Yes Yes Yes MVI circuit for protection against power supply voltage variations Protection class IP 10 CE labeling CE 73
87. t click on Import from PC Hydra to recover data from the PCMCIA card of the logger Actions J fis Equipment Yerification pen Instrument FLUKE 26354 7331070 MB 3 46 00 01 0 L0 8 138400 73310101 Unit E Mew eee PC Instrument Time 00 45 13 13 aa t 05 Barba Tea Memory Card iz OF Size 512 K Free 425 E Mum Of Files 6 Listing The reports available on the PCMCIA card will be displayed choose the file to be imported and click Ok j x From Hydra From file Import Hydra Scanning if in progress will be terminated Mid E 3 DAT OO H TD 15858 8032008 08 45 Delete Format MC Module T UO CH E Oo Pa C Save to PFroqram hliles s Choose the module number corresponding to the module used for running the test with the Hydra data logger before importing the data from the PCMCIA card then click Import and name the test report then close the Import window x Input Test Mame Downloading DAT UD HL Test imparted Cancel The file will be imported in the test list and the serial number of the data logger Hydra module s number will be shown under the Instrument identification gt 65 User s Manual _ rev5 0_Fevrier 2010 XpertVal la XValFL 1 0 1 27 No login Administrator Tests E ma Actions X Lest Imported MM 06704708 AO cc D 252 1BDC986 920 414E 9529 029D8C30E46B Test Data Report Test Template Test Importe
88. t 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 Hydra Agilent amp Test Termination es Test Termination Terminate and Stop Hydra Terminate and Stop 349704 Terminate and Continue 349704 Scan without PC Terminate and Continue Hydra Scan without PC Terminate and do NOT change current status of Hydra Lock Front Panel After Termination 8 Terminate and do NOT change current status of 34970 54 User s Manual rev5 0 Fevrier 2010 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 chosen from the list Information corresponding to this equipment will be added in the header of the report lala Description extra comments in the header of the report T e st D ata Re P o rt Cancel Test Template Hew Test Template for autoclave extra comments in the header of the report Equip Info Autoclave Fede Senal Number 123456 Location Production Production hadra ld dudo odule Id 1 Hydra ENSE 0 08 tha mm ssy Scar Rate SLOW Exported n dataha E THOS 00 07
89. ta will be saved on the PCMCIA card Hydra Agilent jig Test Termination E ic i Test Termination E xj 2 Terminate and Stop Hydra 9 Terminate and Continue Hydra Scan without PE 0 Terminate and do NOT change current status of Hydra Lock Front Panel After Termination Option 1 Terminate and Stop 349704 Terminate and Continue 349704 Scan without PE Lancel Terminate and do NOT change current status of 34970 ft Test Termination 210 xl 2 Test Termination L xl 2 Terminate and Stop Hydra l Ed 2 Terminate and Stop 349704 2 Terminate and Continue 349704 Scan without PC Terminate and do MOT change current status of 34970 O Terminate and Continue Hydra Scan without PC 8 Terminate and do NOT change current status of Hydra r Lack 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 64 User s Manual rev5 0 Fevrier 2010 XpertVal Read data from the PCMCIA card Read data from the PCMCIA card in from Hydra data logger does not apply to Agilent data logger 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 Tes
90. tc A Label configuration of each thermocouple before test starting A 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 PC file A 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 JQ amp OQ provided Standard connectors Control of other manufacturers equipment Hart temperature blocks and smart probe IRTD User s Manual _ rev5 0_Fevrier 2010 XpertVal 2 XpertVal Equipment 2 1 Hardware equipment XpertVal validation system is composed by Data Logger Hydra with PCMCIA card or Data logger Agilent 34970A 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
91. ter the Setup Box follow the instructions displayed on the screen for choosing the directory in which XpertVal will be installed 2 XpertLog InstallShield Wizard m XpertLog InstallShield Wizard Welcome to the InstallShield Wizard for License Agreement XpertLog Please read the following license agreement carefully The InstallShield R Wizard will install XpertLog on your computer To continue click Next Software License Agreement The enclosed software product the Software is developped by Lives International 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 CTh 1 i vathin fifteen 15 days return this entire package urmsed and unopened together with all other iliis du EN E Paa by coca and materials in this program package to the company from whom you acquired it for a full refund re 2 Installsmeld 2 XpertLog InstallShield Wizard i XpertLog InstallShield Wizard Destination Folder Installing XpertLog Click Next to install to this Folder or click Change to install to a different Folder The program features you selected are being installed InstallShield
92. 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 by decimals click on the arrow lola lala Calibration EN 3 Calibration ey ou EE Calibration at 90 dS at 90 Verification at 121 iy at 130 4 at 130 3 W Verification Temp C 90 0 Verification Temp C 4121 0 gt at 100 y at 100 iy at 121 EE 2 RTD amp Block 2 RTD amp Block Error Allowed C 0 5 Error Allowed C 0 1 e Check Time For Error mm ss 3 00 lt gt Check Time For Error mm ss 3 00 Define the drift for the reference probe by clicking on RTD amp Block 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 Aci xi E 3 Calibration Po TEY JK XE ACT diu at 90 RTD amp Block dilq at 130 El Verification Drift Allowed C 0 05 at 100 iy at 121 02 amp Block E Dev From Refer Allowed C 2 0 Check Time For Drift rnm ss 3 00 lt gt 29
93. 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 with Hart probe model 1502 and smart probe 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 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 _ rev5 0_Fevrier 2010 XpertVal 1 3 Advantages Security of data A Data logger serial number contr
94. tion Member must change password at next logon is used to give the ability to the user to create his own password when enabled by the administrator 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 amp 3 Equipment Ra Options Location C Xlog_0 6 delta dsl SG Members ID OD 8F 9F 3F F945 4CD3 9C72 1 034E 0E FOD 4D Admins 25 User s Manual rev5 0 Fevrier 2010 XpertVal Audit Trail Audit trail enabled need to be enabled in order to generate the Audit trail report Administration Options edm Members 0 Admins Users Reporters Reviewers Show Audit Report Browse for Audit Database Audit Trail Enabled Format Report erif 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 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 All options activated iz XValFL 2 0 0 0 admi
95. type CAL STR The response should be xxyyyyyyyy FACTORY CAL dd mmm yyyy if the expected response is not returned turn off then on the logger and restart the procedure Procedure to program the serial number for modules of Agilent e Insert the module on slot 100 Type DIAG PEEK SLOT DATA 100 The expected response is tt meaning the serial number of the logger is not entered e Introduce the serial number Type DIAG POKE SLOT DATA 100 aabbbbbbbb Where aabbbbbbbb serial number of the module e Verify if the serial number of the module was entered Type DIAG PEEK SLOT DATA 100 The expected response is aabbbbbbbb 1f the expected response 1s not returned turn off then on the logger and restart the procedure e Disable programming of the logger type CAL SEC STAT ON HP034970 then type CAL SEC STAT Terminal should respond with 1 Ts User s Manual _ rev5 0_Fevrier 2010 XpertVal 2 4 7 Connecting data logger reference probe and temperature block on XpertVal software Insert the PCMCIA com card into the computer Start up the computer Connect the data logger to Com 1 standard RS232 com port of the computer Connect reference probe to one of the two extra com ports available Connect temperature block to the second extra com ports available Start XpertVal Press Equip Select Port 1 Baud 38400 Module 0 for Hydra Probe Mode Comm port Port
96. uids Ensures correct calibration with built in automated functions A large and clear easy to read multi information display Range of temperatures from 90 C to 650 C LIVES Series temperature blocks in pharmaceutical process Traceable simple and fast Specifications Units B mE Fr ida gt Pi g e 650 Temperature range 45 LL C max bs 125 C 155 C 155 C 320 C 650 C Well diameter mm 30 mm 20 mm 30 mm 30 mm 30 mm Well depth mm 185 mm 150 mm 150 mm 160 mm 160 mm Accuracy C 0 3 0 06 0 19 0 04 0 19 0 04 0 26 C 0 07 0 39 C 0 11 C Stability C 0 03 C 0 02 C 0 02 C 0 02 C 0 03 C Axial Homogeneity 40 mm C 0 05 C 0 05 C 0 05 0 1 Radial homogeneity between borings C 0 01 C 0 02 C 0 02 C 0 01 0 05 Stability indicator Yes User programmable Max resolution C 0 01 C 0 01 C 0 01 C 0 01 C 0 01 C Heating time ambient temp to 125 min 20 Cooling time ambient to 80 min 70 Heating time ambient temp to 100 C min 23 23 7 27 Gooling time 100 to ambient min 6 9 22 43 Automatic switch test Yes Open Close Hysteresis Programmable slope rate C min 0 1 to 9 9 Auto step Yes up to 10 steps Line voltage VAC Hz 230 50 60 or 115 50 60 Dimensions length mm 506 352 height mm 448 156 width mm 200 360 Weight Kg Ib 20 44 1 13 1 28 9 12 2 26 9 10 1 22 5 12 1 26 7 FPSC Yes Dual Peltier zone Yes Dual heating zone Ye
97. uivalent 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 Sie User s Manual rev5 0 Fevrier 2010 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 E XLog 1 0 0 6 admin Administrator Equipment Info x Mame fLocain Ser a Incubator Microbiology INC 55 678 3DE35547 B1B0 4382 B5F2 C4FEDE 4DA 382 e Oven Lab OV34 45 12D8A393 C7FE 4848 3198 E 4634CCB7F3D amp Autoclave FED 005 Production 18081 772 9545 4DB1 99CC 8581 0B8BB 711 E Equipment Info Autoclave FED 005 zu 112345 67890 o Injectables autoclave Click on Listing to display the report of all equipment defined ER 2 0 0 0 admin Administrator Report Preview Form E DEA Page 1 of 1 Equipment Printed 01 11 2008 21 00 22 from C Program Fil
98. view Report when the reviewer will review the report the software will re demand a password confirmation to electronically review the report 1f the option 1s enabled Allow to Modify Equipment Info If the user made a mistake when linking a test to an equipment he ll be able to modify and associate the correct equipment to the test even after the test was saved 1f the option is enabled 24 User s Manual _ rev5 0_Fevrier 2010 XpertVal Members Create new members on 4 different levels The administrator has the ability to modify the password change interval and the password minimum length S rico EE Password Change Interval 90 Days C Import Members List from DB or file E Admin Users S es B Recon Password Minimum Length 4 chars Reviewers E Database at ia m mius Audit Trail E i 2 E Table Password Change Interval 90 Days E Edit Member isl xl 2 3 Auto Name Format A Level amp Template Password Minimum Length 4 chars Login ii E Test e Administrator Calib Name l Report b C User a Verif p d j amp 3 Report options lc O Reporter Retype Password O Reviewer Member must change password at next logon Create a new member Click on the level needed to create new entry Click on New Member Define Login Name enter full name Password Retype password Redefine the access level Click Ok to acknowledge creation of new member The op
99. w test 6 Iv E 2005 ao t 13 New template 2 Enregistrer sous Ei x Enregistrer dans C9 xvalHp 06 J 2em S ve m i port to file will be create Fe C XValHp_0 6 export_test dhe a emm Items to export 2 Export Test 2005 ao t 13 New test 6 Mes documents r cents Bureau iv j J 2005 ao t 13 New test 6 Iv E 2005 ao t 13 New template 2 amp A Mes documents SE Poste de travail a mess Nom du fichier Jexport_test Type Export Files dhe y Annuler Za Information Once the report was exported the message Export completed will be displayed Import Warning a report exported from a data base can not be imported in the same data base In order to import a report in a different database click on Import in the Main Menu find the report to be imported and double click on it az XValHP 1 0 0 6 No login Administrator Setup Equipment Regarder dans xvaHp 0 6 j2 pe mj export test dhe Administration Calib erif Config F Value Config Mes documents r cents Bureau Action Equipment Info Template S Calibration Mes documents Fr 7 Poste de travail Verification Test Application o a Ea BEN TR Nom du fichier Fichiers de type Expor Files dhe y Annuler Zo H
100. when the report is created Calculatable 68 User s Manual rev5 0 Fevrier 2010 XpertVal 3 2 12 Application About Click on About to get software information about the serial number of the license and location of the software XValHP 1 0 0 6 No login Administrator i About xYalHP EEE ixi p r ee Wersion 1 0 0 6 XVa H P Company valuation Serial Num 32018 81132 04334 24284 Application 3 2 13 Application Exit Click on Exit to exit the software Application 69 User s Manual rev5 0 Fevrier 2010 4 XpertVal Technical Specifications 4 1 XpertVal 21 Thermal Validation System Uncertainty XpertVal XpertVal Validation system uncertainty under worst case after thermocouple calibration Data logger Hydra Conformity error A D Conversion error Compensation error 250 C 0 04 C 0 02 C Total logger uncertainty Calibration equipment Hart probe 5614 Hart display 1502 Temperature Block 155 320 0 021 C 0 01 C Total calibration Equipment uncertainty Total XpertVal validation system uncertainty A sum of data logger and calibration equipment B cf guide AFNOR XP X 07 020 square root of the sum of squares of each uncertainty Total system uncertainty maximum is Total system uncertainty typical is 70 0 191 C 0 143 C 0 24 C 0 167 C 0 191 C 121 C amp 0 24 C 250 C 0 15
101. z Te T penet Yes 1 00000 Add Info Te T penet Yes 1 00000 Te T penet Yes 1 00000 z Tc distrib Yes 1 00000 amp Slot 100 349014 z Te T distrib Yes 1 00000 Slot 200 NI Te T distrib Yes 1 00000 lat 300 N E Tc T distrib Yes 1 00000 Save Slot Config Input All Assigned Tem distrib Yes 1 00000 TEST distrib Yes 1 00000 Tet distrib Yes 1 00000 TE T distrib Yes 1 00000 TET distrib Yes 1 00000 Te T distrib Yes 1 00000 OFF m N TTK KRN RO NN BON KRDN NM NN T KN TN JE OFF NM User s Manual _ rev5 0_Fevrier 2010 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 sr value cono Chan List Config wur F th rune As al LJ fe F Value Config Chan List Canfig E niir le T temp iv 1 Tet temp n Iv 12 Te T temp n Iv 13 Te T temp Iv 14 Te T temp n Iv 15 Te T temp r Ive 16 Tc T temp n Iv 17 Te T temp n Iv 18 Tec T temp E Iv 13 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 w

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