XpertLog - FLW of PA, Inc
Contents
1. 4 8 meaucea amensione Factory recommended re calibration interval 12 month 6 month Temperature and pressure loggers Humidity loggers 54 User s Manual _ rev 1 2 August 2007 XpertLog 4 3 Temperature Reference Probe Temperature display Technical specifications Resistance Temperature range Material Hysteresis Accuracy Dimensions Model Reference probe Temperature range Resistance range Probe Parameters Accuracy Temperature coefficient Temperature resolution Resistance resolution Calibration Display Dimensions Weight Type 100 ohm nominal 0 1 ohm a 0 C 200 a 500 C inconel lt 0 01 C a0 C with extremely points 183 et 420 C 0 018 C 196 C 0 018 C 0 C 0 019 C 200 C 0 023 C 420 C Type 5612 0 187 dia x9 0 475 x 22 86 cm Type 5613 0 187 dia x62. When all loggers are programmed for calibration remove them all from the station and click on Step Completed A warning message will appear informing users that the setup of the loggers was completed and loggers should be transferred to the temperature source e g oil bath After the loggers have been transferred to the temperature source click on Step completed the calibration will start the oil bath and the reference probe are controlled by the software during calibration changing from one set point to another is performed automatically by the software When calibration 1s ready the software will request user to enter the calibration name and hit Ok ewe Jolie oa UE EHE T TERT PEUBESTCCGB MENT damag V mami id ud om a CEST TES 254 User s Manual _ rev 1 2 August 2007 XpertLog If the loggers have not been placed in the reader the message Loggers not found will appear 4 iL E ALO BALLE X In this case place the loggers in the reader and click Refresh Loggers and Retrieve data After data from all loggers were downloaded the message All required data downloaded appears Click Ok close then open Calibration to see the list of calibration reports PE redd b Ga BETETE ET ya CARATS TAC be Ga SUE O12 e da BLEUE 1504018 by 58 UOTE 13218 by 3a TIAS 1510344 br Sa T
3. 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 Stule Windows PM Flat Office XP Metal Raised Options Administration will define members rights DEDITETEERIELT Anwerdchi n BEC EC h Aou artus e boost Fara On Zi Cesa OF F Lire Tad Asirin Um dz Setup Loggers Fer ces abba bounce On Es Faika Dal learn Lesen as Eph Arapa Tinchy dran ipa L e P Fuere Ea L pod impok Ves dih ddr ice I Cese CF Line Tests Mi Cese Statistics 1 Bninike E ion C alib store Deign Farat Ainin M Exporiewpot Tesis Lave Repos Ahin Lie Reparei mz Esportingest dent and siis it Haras pts era pen Et Cassie Ji hl ces To Fever Cen Aap Dn LE Design Rancs FF Shom diction Hinds On Aa ee Plage Feira lien Tl e quraion E Fara Hapati Aorem Eo ake TiAl R On ka Enr es f Highkghi E nae m Alegent rn FF Actene Dates Aepacene On seve Cab Date Warn On rT d 14 User s Manual rev 1 2 August 2007 XpertLog Options available delete tests double click and define the level allowed for the action delete Verif and Calib double click and define the level allowed for the action setup loggers double click and define the level allowed for the action retrieve data from loggers dou
4. export and linked objects will be visible Click on Delete in order to delete the calibration report A comment window will appear to request a comment enter before deletion of the report Click Yes to delete the report anfirmak inn Open the audit trail and check the comment was added ee ab 2 LATE CHEE FA E h PRES d PRE Dnus j ba ib pp opinga d jmd ur Crem erac ds kim rpe ei des hmi nca es oe 33 User s Manual _ rev 1 2 August 2007 XpertLog 3 2 7 Action Verification Verification is used by user in order to verify 1f needed if the specifications of the loggers are within the specifications defined Two types of verifications are available on line and off line Off line verification This type of verification is performed when more loggers then available slots in the docking station need to be verified simultaneously Calibration equipment used will be the oil bath and the reference probe Procedure In Verification module click on Off line Verif the loggers and the equipment used for verification are displayed on the screen Click Ok the configuration screen will appear to allow the user to change verification configuration Define verification steps as described in Calibration Verification Configuration og EBPIGELLI TILES Lnd un Fri Click on Loggers setup the system will scan existing loggers in the station To program the loggers for ver
5. If the serial number displayed 1s only the last three digits or it doesn t corresponds with the serial number physically labeled on the module then it has to be changed Enter the following command in order to access the serial number modification PA 2051 Enter the serial number of the module SN xxxxxx Enter the command SN to display the serial number check if the serial number displayed is correct Enter the command PA 0 to lock the calibration menu III 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 communication card available extra COM ports are available IV Connecting data loggers reference probe and temperature block to the computer Insert the PCMCIA communication card into the computer Start up the computer Connect docking station to Com 1 standard RS232 com port of the computer when available Connect reference probe to one of available extra com port available Connect temperature block to the other available com port available Oh User s Manual _ rev 1 2 August 2007 XpertLog 3 XpertLog Software 3 1 Software installation and starting Install XpertLog Warning Before installing XpertLog software disable screen savers of the computer and the stop of t
6. XpertLog USER S GUIDE Revision 1 2 August 2007 gt amp er 4 h eo amp User s Manual _ rev 1 2 August 2007 ID Introduction 1 1 Introduction 1 7 Concept 1 3 Advantages XpertLog Equipment 2 1 Hardware equipment 2 2 Different XpertLog Models 2 3 Minimal Configuration of XpertLog Validation System 2 4 Hardware configuration XpertLog Software 3 1 Software installation and starting Install XpertLog Uninstall XpertLog Start XpertLog 3 2 Main Menu SAR Setup Equipment Configuration Equipment Equipment Connections Verification Reference Probe 3 4 2 Setup Administration 3 2 3 Setup Calibration Verification Configuration 3 2 4 Setup F Value Configuration 3 2 5 Action Equipment Info 3 2 6 Action Calibration Off line calibration On line calibration Calibration reports Save calibration reports Export calibration report Import calibration report Delete calibration report 3 2 7 Action Verification Off line verification On line verification 3 2 8 Action Test On line test F Value configuration Test configuration Start on line test by time Virtual channels Add info Start On line Test Off line test Data retrieve Compile data from loggers Create new report and define start and stop time Test Report Trend 3 2 9 Battery change SOP XpertLog Technical Specifications 4 1 XpertLog Thermal Validation System Uncertainty
7. ai is E on ia wm cmm a Le Sn ras m af EE a a ol on ll om m Er EES SAS 5 48 dB ZA 4H JF 8 E Gm JE J ao JE dH ZA dH GE SX JB E SE 8 B n a um m m PE e m mms np m os el ss oem se as oss m 7 wu m mum EE a BE EE uU a PF GT De EH Ge uu a aum 4 a7 HE GU G7 a EF oe oe Er ge ay as a um SG JUNE Gus JO JE HN AN dE ON SN UH M im EUER JU ON SN JO 473 SF JU AN GE SM 4H HD SU d B zm om E 5 AE EE SI JR SU mo JS dE aeo Ji c GE E JU JE ax SN JU E UE JS HE SN JE ow a des bam 5 sf a 5 5 mo mm xU m dE ox sm be ee DEM e dy n F BO Dod m ow oum Click to enlarge report view By default view of calibration report 1s data values The header contains data about the license used version serial number etc comments and the configuration of the calibration The calibration report will show the errors between each logger and the reference probe before and after correction Trends are also available for calibration Add info option will allow user to insert comments in the header of the report Remove a logger from the report disable the logger to be removed from the report and click on Rebuilt report 30 User s Manual _ rev 1 2 August 2007 XpertLog Save calibration reports Calibration reports can be stored in different formats by the user 1 pdf click on disc icon to save the report choose the path to store the report C choose th
8. 0 475 x 15 24 cm Type 5614 0 25 dia x I2 0 635 x 30 48 cm HART 200 650 C 0 to 400 ohm 25 or 100 ohm ITTS 90 IPTS 68 or Calendar Van Dusen 0 006 C 0 C 0 009 C 100 C 0 012 C 200 C 0 018 C 400 C 0 024 C 600 C lt 0 5 ppm C 0 001 C 0 0001 ohm The coefficients are corrected in the equipment during the annual calibration The formulas for ITS 90 are stored in the thermometer s firmware The display shows the real temperature 8 digit 7 segments LED 14 3 x 18 1 x 6 1 cm 1 Kg HART SOFTWARE for reference probe The RTD Thermo software of LIVES International allowes Display up to 9 reference probes in the same time HART probe or intelligent probe IRTD Trace the report under EXCEL with the continuously record of the 9 probes Useful for the probes calibrations in the field 255 c User s Manual rev 1 2 August 2007 4 4 Temperature blocks LIVES ATC 125 ATC 140 ATC 156 ATC 320 ATC 650 Fast calibration due to special design of the block and no use of liquids 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 XpertLog Specifications Units rabat 125 Pu ATC a ae 650 max 125 C 30 mm 185 mm 0 3 C
9. Online calibration Off line calibration This type of calibration is performed when more loggers then available slots in the docking station need to be calibrated simultaneously or the type of loggers does not allow on line calibration Calibration equipment used will be oil bath and reference probe Procedure In Calibration module click on Off line calibration the loggers and the calibration equipment used are displayed on the screen Click Ok the configuration screen will appear to allow the user to change calibration configuration Define calibration steps as described in Calibration Verification Configuration Less Pe ee es ee Css Col CHI H ADE Fini ee Click on Loggers setup the system will scan existing loggers in the station To program the loggers for calibration click on Setup Loggers and then remove them from the station To program more loggers then slots available in the station insert the loggers which are not yet programmed in the station then click Refresh loggers and Setup loggers as many times as needed to program for calibration all loggers When clicking on Setup loggers a warning message will appear to inform the user that all data stored in the logger will be overwritten choose Yes to proceed When loggers are programmed for data acquisition the icon corresponding is clock blank ampoule D User s Manual rev 1 2 August 2007 XpertLog
10. 0 03 C 155 C 20 mm Temperature range Well diameter Well depth Accuracy otability Axial Homogeneity 40 mm Radial homogeneity between borings Stability indicator Max resolution 0 01 C Heating time ambient temp to 125 C i 20 Cooling time ambient to 80 C i 70 Heating time ambient temp to 100 C i 0 02 C 0 05 C 0 01 C 0 02 C 0 01 C Cooling time 100 C to ambient Automatic switch test Programmable slope rate Auto step Line voltage Dimensions C min VAC Hz length mm 506 height mm 448 width mm 200 Weight Kg Ib 20 44 1 FPSC Yes Dual Peltier zone Yes Dual heating zone Yes Yes MVI circuit for protection against power supply voltage variations Protection class IP CE labeling CE 13 1 28 9 56 150 mm 0 06C 0 19 C 0 04 C 0 19 C 0 04 C 0 26 C 0 07 C 0 39C 0 11 C EM 155 C 30 mm 150 mm 320 C 30 mm 160 mm 650 C 30 mm 160 mm 0 02 C 0 02 C 0 03 C 0 05 C 0 05 0 1 0 02 C 0 01 0 05 Yes User programmable 0 01 C 0 01 C 0 01 C 23 7 22 Yes Open Close Hysteresis 0 1 to 9 9 Yes up to 10 steps 230 50 60 or 115 50 60 352 156 360 10 1 22 5 12 2 26 9 12 1 26 7 User s Manual rev 1 2 August 2007 XpertLog _57
11. 1540021 by So 00 AGE SC FLE HT LEUTE IHE 32 MR PME 12D 7 4 SCC QE Bir Gn TODOCCD34 5E 2 48 CS 138 8 0 NETAS 3052 4DFB S8GT EZFEE ae CESSER AA TAC BB BS SBE 2a Tec FBDAGACHT ASE ete DOTE ai n Oewed 7 User s Manual rev 1 2 August 2007 XpertLog Calibration reports After the calibration was performed the report will automatically be created and stored in the calibration report list EIE db SI PLI alien m jHws Palmas E E STS 19503 be cn H 5 EN an DE P oe 2 AE DEUS E ee Den Open the report to display calibration data m am rir UET m T ER EU lxi Jia LR ME Du PEN nm Umm CE CE Ne 27g 7A a CORNE CORRE x meme ob cwm im une See ics us r ql id om 7 SN HOS ES n NEM n coms oe me I uo Gu OS nt PBRlCE hic Hm DN EE E u TEE ES E im may uad e ma UNES iE wm M ES Hs OI Y lH HE i E LEL ef mm mm mp n SE EDI ee ee DELE E pe LE RU pe L LLLJL L LEE Le EE ELI Eres ER Ek Fe li um TES um EE S m er ur Em VE L d mra r r as Er A mu wu m iad mur Er Lt EN mr FE m mm FF m Ei m om Hmm uua kl 7 n AU EET nl Ee Suae uum RECS ts a ass m m m Fami Ee a7 uum UD Ds T DT Xu RERO MAU Wc l nt um En m _ om E m EE EE mm E bii un st IE HUNE NUS DE EE AT G7 GU GU Gu DR GF GM EN GU UN G EELE PRESS EN GU HN HE OG a a rr ug ar BE LE An BE T 1 EH UE UN
12. 4 2 XpertLog Technical Specifications Factory recommended recalibration interval 4 3 Temperature standard 4 4 Temperature block XpertLog 0 D 00 II a 00 UR uw YW User s Manual rev 1 2 August 2007 XpertLog I I 1 Introduction Introduction XpertLog is a stand alone thermal validation system that simplifies the entire validation process by significantly reducing setup minimizing sensor handling and presenting critical study data in easily customized report formats This advanced system is specifically designed to conform with new FDA electronic records guidelines 21 CFR Part 11 and meet international and European regulations for validation of pharmaceutical biotechnology and medical device EN 285 EN 554 HTM 2010 manufacturing plants XpertLog is a portable instrument intended to be used throughout the facility on a routine basis XpertLog is the latest generation in Lives International s line of thermal validation systems It is composed by wireless data loggers easy and quick to program and to use for validation purpose or for day by day routine testing The loggers were designed specifically by Lives International to meet current thermal validation needs and regulations XpertLog can accommodate unlimited number of wireless data loggers the sensor used for temperature measurements is a 4 wire class B 1 10 DIN RTD Loggers programming and reading is accomplished through a Docking Station a modular logger input interf
13. Ce DI adr NEMPE LLL i Penis ny huge inm Harl pm creer de parer iE el ee a red res ipsii cg o rmnonua i TEFIE cenis ee FEAF hu dae ma r Pipi or UD r De ne Ge mg Po One Pics TI AE raah iie Berre ihr hepa Wome ner claram a eee Lee pe norm Eee ce ee ndi ns nec albidis wizard Dope kr ba hole or iuga ind m 7d ua mori kin reira vr curae mn nl rp cie Rs The eni sach eed Fors a imr nerd alid sor mg CE Prah tg acit Peg nima In order to completely uninstall the software the user needs to delete XpertLog folder from where it was installed In order to uninstall the software you can use Add Delete Software in control panel make sure the software is shut down before uninstalling it User s Manual rev 1 2 August 2007 XpertLog Start XpertLog NIMIUM Eel be 34508 7521 16225 7 A Setting database Cies Doo 0e dd 4 Felocnnag problerrrs detected Settings Database not Found Setting Catabaie CPC Error Press Ck bo continue vL Nes Dad dbi rai pibe cited wur wm Superis CO plicwes Define a new data base a new audit trail will be generated automatically Create New Database xl 6 4 l Database C XValFl D xxxM bel created y Audit file required for db C xValFl_0 xxx1 dxl not Found 2T asd 7 Mew audit File created and audit trail has been activated XpertLog starts SS ro ur i First time when XpertLog starts the user
14. GE Gu AH JE GE GS JH GE GP d GE Gm JE G EE VINO ME EN gH dE 4 dH GE uU JE DE Gu dU dH Gub d Mm MTM MM a a A E E a d E E d E a A E O DS Gama a al acu SJ iim moo JE almo mudo JE SS a oi ppc ms EE mm e om o E m da a sm o m meo mi mn mi m i a INO Ow m mm m un mis mom mm um mm 7 t nas mm c a um m m um ne m m mm mm k as mm Em UEM USC aa um cm m um me a a LE m mu mam EEE mcus HE PF c p mH pE PF oM E mmm m l DEEE pep VEN ug mp mm o 0mm pE mp mm F IE mm T om EB MEN RUM DE Gu A dB JON JM Jg NE JP GM RS Gu JN G li SS GUN IU ANM S HE GU GU dH IDE SE AP EE GV 4 GB Gus de E EEE FEN SEE GE us JE d zm JH ZH SN JU GE s JE d f EE EE HN E Z4 d dm JH GE SU JE AE JU 4 dE a E NEUE JE Gm AH d E AH dH SU IH dH GE GX LE d DR EE GENE IZ JE JE ZA JH GE GAS JH GE GE JS JE GE IE uni EIE ON JE IX LE dE E JAL JE GE GB JH E GA JE d EE LE JE LE dH JE JE GE GIL JH E GE JE E n we om EI cm um e m m m m meu m DEME E SEO e um LE LE o a o oo um udi mm mnm ou dux oua chm bE RA d mo du od LE imum i dx dub dm cha du R cha um ud in ni FFE Er uS FE F E F per a Ea EF E E r LE m FRE TE DE m a mm Li m oio FE a Ee F i EF F 7 am FEE EFE qum 27 ae dE a CE anm wr a Je of 3 all Pa BH E CLS aa a an BE Ci P mm B PE ag it m mmi hai QU E x al aif JE WE CE CE T rz al BLS a ail ail ri SE J CE al i E a SS 5 d a
15. Trail Audit trail enabled need to be enabled in order to generate the Audit trail report Pee E H dd ki Opia Shoe laxi Mapai E ijen Teram ka Mae Data 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 Rebuild Report Select All Unselect All 16 Iv Audit OFF M Audit ON User s Manual _ rev 1 2 August 2007 XpertLog All options activated Only start test option activated FRE m mnt ME mue ne Ro wm wm P mu ln m a Emil bmm ii d RR mco mme D cuum d Race HERR Los Hana CON ER adire ERAS E GOD He DURS DS EE ocn in Lu xem m bi Ua ERE ORE Tl os m m m m B Auto name format The default name for test or calibrations reports is suggested automatically by the software NE Um User s Manual rev 1 2 August 2007 XpertLog 3 2 3 Setup Calibration Verification Configuration Loggers calibration Although the accuracy of the data loggers requests only annual calibration the user might need to calibrate or verify data loggers as many times as he wish
16. XpertLog will allow user to do so In order to run calibrations the option Allow calibrations must be On in Administration Options ui DOO O O O m oor y LA daa r oor oe co i T b Be m ox lt ee ee Woe Cet a So ries le Bs iim n Bl rint ag r1 B us L le d 3 a Le Tm a Dj EOD mie et R D mms e RDS LEE EE Two types of calibration verification are available A Off Line Calibration On Line Calibration For both types the configuration can be set by the user from this menu Calibration Verification method The calibration verification 1s performed by comparing individual temperature values of each data logger to the NIST or COFRAC independent temperature probe A very accurate calibration can be performed if the RTD probe and the calibration block bath are of the highest quality as specified by LIVES International XpertLog allows user to perform completely automatic hands free calibration by controlling data logger reference probe and temperature block bath the block bath will automatically switch to calibration verification set points as defined in the Calibration Verification 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
17. both low and high temperature set points with an optional third set point for a mid range temperature check User s Manual rev 1 2 August 2007 XpertLog 1 2 Concept XpertLog is the latest generation in Lives International s line of thermal validation systems It is a compact modular and portable data logger designed specifically by Lives International to meet current thermal validation needs and regulations XpertLog software is designed to run on Windows 95 98 2000 NT or XP and provides everything needed to perform validation testing Using the XpertLog software a system administrator creates user accounts and assigns user IDs passwords and access permission levels that identify the person operating the instrument and prevent unauthorized operation Validation study setups which include calibration criteria are programmed using the XpertLog Software and can be run in standalone mode or under PC control The XpertLog 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 loggers controlled by XpertLog have 16000 data points memory XpertLog is designed to write data to internal memory and then download the data in the data base in the computer XpertLog system
18. for all types of XpertLog data loggers In order to perform this operation make sure you have available tool for opening the loggers Silicon grease batteries o rings for the loggers loggers Operating procedure use the tool to block the lower part of the logger and unscrew the upper part take off the battery from the logger take off the o ring clean up the thread replace the new o ring place the new battery inside the logger in the battery supports lubricate the thread using the silicon grease close the logger by screwing the lower part on the upper part use the tool to block only the superior part of the logger and thread the lower part by hand only till the end clean up the silicon grease place the logger in the docking station and test the communication with the software start the software and log on as an administrator using Id and password goin Equipment and click on Verify click on the button Config enter the date of replacement of the battery battery replacement interval and the alert in advance interval click Ok to exit inorder to automatically be warned by the software about change date of the battery go in Administration open Options and enable Activate Battery Replacement Em User s Manual rev 1 2 August 2007 XpertLog 4 XpertLog Technical Specifications 4 1 XpertLog Thermal Validation System Uncertainty Uncertainty c
19. i i 1 1 1 1 1 i i i i 1 ia ih e t z t t 1 t T Ti Ti t Li ua 7 T ALL Thi dap b ss s Tum ELT TLL U TLL Ti TLL Ti LE i HEE ud ntt 4 HE E TNI T ETILA T EL H EL WO diui U QS T XpertLog User s Manual _ rev 1 2 August 2007 XpertLog In order to choose the data for report right click on the logger which contains this data and enable Use If data from several loggers are needed right click on the date and time corresponding to this loggers in download time Enable to retreive data from single logger Enable to retreive data from several loggers Create new report and define start and stop time Once the loggers have been choosed the options in Views menu are enabled and the user can visualize data to be stored in the report Click on Grid to see all data from the loggers defined previously In order to define a specific start time set the cursor on the date and time which will be defined as Start time right click there and enable the option Mark Report Start 1 TIT IT THE n ai LEEEEEEEEEEE Le 1 11121212212111114 m titi EEEEEEEEEEE EL EE HELENE MELLE a 5 HEDEEEEEEEEEEEEEEEELE TR JJJ 131111111 EERER RESTS Idd 1111135 maT eon amp a a E i a A h i i ib bbbE t EE E EEEET E i REE EEEELEHEEEEEECEEEEEEEEEEEEEEELE LEUR
20. is designed to operate with the Lives probe connected to the block with Hart probe model 1502 and Kaye IRTD and the Hart and Lives temperature blocks or cryogenic bath The equipment provides NIST traceable calibration of loggers used in thermal validation studies with a range of 50 C to 150 C During calibration verification XpertLog automatically reads and monitors the temperature of the reference probe For loggers calibration or verification the reference probe functions as the standard for correcting loggers readings The Temperature Reference provide highly stable temperature conditions for sensor calibration and respond to pre programmed calibration criteria allowing automatic loggers calibration at unlimited temperature set points with an optional unlimited set points for verifications User s Manual rev 1 2 August 2007 XpertLog 1 3 Advantages Security of data Data logger serial number control operation Pyramid operations Calibrations Based on Calibration gt Tests Test Minimize or eliminate calibration of loggers factory accuracy is 0 1 C Introduce the notion of verification only if necessarily Reproducibility of results using completely automatic calibration Security and access levels programmable by the system administrator Electronic data protection and FDA 21 CFR part 11 Audit trails Automatic operation for loggers calibration verification Calibration and test reports generated aut
21. temperature calibration verification temperature Unlimited number of calibration verification set points can be defined The stability of the system 1s defined as the value of the drift of the temperature allowed during the defined time for drift After calibration started the RTD temperature value will be read and stored every second during check time for drift This 1s to make sure the drift defined by the user was respected At any time if the drift exceeds the limit the check time will be reseted After the drift is within the limits defined by the user the calibration will start After calibration was done the loggers are verified to confirm the corrected reading 1s within the user specified logger 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 logger which does not meet user specified criteria of error allowed will be set OFF 18 User s Manual rev 1 2 August 2007 XpertLog 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 niti ni 4 I qn Cancel E RTD t Bleek Liban Kebab dum 0000 qn
22. will be logged on as Admin with no password required 10 User s Manual rev 1 2 August 2007 XpertLog 3 2 Main Menu XpertLog is structured in modules for a better understanding and simplicity of use Select any module by clicking on the appropriate button The structure of the software modules Setup Equipment Administration Calibration Verification Configuration F value configuration A Action Equipment Info Calibration when enabled Verification when enabled Test Import Application Help About Exit aT User s Manual rev 1 2 August 2007 XpertLog 3 2 1 Setup Equipment Configuration Equipment User has the ability of choosing the combination of equipment needed click on Equipment then make your choice Loggers user needs to define the Com port for the loggers communication speed is always 38000 baud Probe Define com port Baud Type JQRTD Hart DTI SI Lives Int Lives Ext Number of digits choose 3 Block if the choice of the reference probe is Lives Int or Ext Then Block module is disabled the block is controlled through the probe fany other probe has been chosen then user has the choice of the block Hart or Lives 2172 User s Manual rev 1 2 August 2007 XpertLog Equipment Connections Verification After the configuration is ready click on Verify A dialog box will display the connection st
23. 200 5 19 User s Manual rev 1 2 August 2007 XpertLog 3 2 4 Setup F Value Configuration The module F Config will configure the calculation of the F value in the function of the test type steam dry heat with or without depyrogenetion The instantaneous lethal rate F value of a given steam sterilization cycle is the lethality at specified conditions and can be calculated once the D value and Z value are known using the following algorithm p 107 7 Z Where To Temperature within the item being heated T Reference temperature Z Z value of the challenge organism For steam sterilization the values typically used are T 121 1 C and Z 10 C When these values are used the F value is defined as the Fy value The above equation is an exponential function and therefore as To increases there is an exponential increase in Fo Note that for Fo the instantaneous lethal rate at Tp 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 algorithm Fo Y107 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 algorithm LR F D Where LR Log reduction Fo The accumulated let
24. AREAS 150023 by Sa EU XpertLog User s Manual _ rev 1 2 August 2007 Double click on the report to open it LE tvm B de DEUM 115 aL Bij LLES SE PRET CNE LIN MERE LL kap ee Deer skp n BA der a Li sl i D me Deni Re rh rn si A D a US e CO Se D OL DE SON Ti p Emn il Hora Fem EN EE E Era ay Be gg bere Bee EN Hai Lum os The report will display the temperature value of the reference probe and the error of each logger versus the reference zs User s Manual _ rev 1 2 August 2007 XpertLog On line calibration This type of calibration can be used when the number of loggers to be calibrated is less or equal then the number of slots available on the docking station and the type of loggers to be calibrated is flexible RTD In this case the calibration equipment can be oil bath and reference probe or dry block and reference probe Procedure In Calibration module click on On line calibration the loggers and the equipment used for calibration are displayed on the screen Click Ok the on line calibration screen will appear click on Calib Config to modify calibration configuration Define calibration steps as described in Calibration Verification Configuration In order to visualize calibration configuration bring the mouse on Calib Config calibration configuration will be displayed at screen EI Feo E PC Era Mice DUE Le CS Cu Ra fe nl IEE
25. E m NM Ln 2 1 kcu m 200 6 07 paer Poe Rhen Bcc m g TL Check Tr Pee Cir m D mm e Click on Start Calib in order to start calibration Enter the name of the calibration report and hit Ok Calibration will start S m User s Manual _ rev 1 2 August 2007 XpertLog Calibration will start with first checking stable environment for the reference probe and temperature block or bath ecking the drift of the reference probe before starting the calibration Once the drift 1s stable the software will read data at the defined set point then will automatically switch to the next set point After reading data in all defined calibration set points the software will automatically switch to the verification point and display the corrected values in that point Lag LADE sorin S 0 ga a Laugh Calin feline Value of the reference probe in verification point Corrected data after calibration _ 28 User s Manual _ rev 1 2 August 2007 XpertLog Double click on the name of the report in the list of the reports to open the calibration report uo Rahmim rali Labdrr al is m ET Lsibeskoan Once FS n ire Csin A Cedbastion fi inggers for esse dyar FJ 2005 un 05 Hea call 2 E Chn ac 25 C JF Chisin a 150 C JF Chisin TOUT JFJ Cabhin a0 OI E ES f ms Hee cal 3 29 CRE STD So 0590605 13755 by So 15409 b in SISA D1757i Sn ZEN 15D TOES Se SE 12 Eh Se LPO TETE 5 0 1703408
26. S Im TE TE LL As TE i TE im ini ion ini imi VL Lm EEE tum EL LTT iT p Rr wm 13 ol wll FG ii rH 2 Be 15 CEE oD 1 14 PEEEEEEEEEE The report will start then from that specific data point to define the Stop Time define similar configuration except you have to move the cursor on the stop time date and time right click and enable Mark report end bo d db od od mod bod b d bod h d us J J al d Fr x User s Manual _ rev 1 2 August 2007 XpertLog Save the report by clicking on Save in Action name the report then click Ok The report will be added at the test list Save the report i D B ppp TM SD o Hmm 3m HARF o Sm 5 a remm apta im ipm ar ees Ps P T LEE EEG Test Report Open a report from test reports list Data points will be displayed as a test report on screen the report will have all the information needed by the user in the header name of the test report comments inserted by the user equipment information Feonfiguration information allthe calculations defined by the user in Virtual channels Trend In the report click on Trend The trends will be displayed at screen to enlarge click on the dots next to the trend 5 User s Manual rev 1 2 August 2007 XpertLog 3 2 9 Battery change SOP This section describes the procedure of changing the batteries
27. a emu os CICR ED To modify the settings of the set point click on the specified set point and modify temperature error allowed check time for error by using the arrows next to each parameter In order to increase or decrease the value bytenth hold simultaneously Ctrl Shift and click on the arrow up or down byunits hold only Ctrl and click on the arrow up or down bydecimals click on the arrow sole glim Done by F all sole glim L on bey EL 1 EL Chose Cuban E me maa 2 vet 18 Cai TIE im oe z w Vanbcahon Teen CI 28010 Lew z w Vanbcahon Temm CI EET p Lew mm a 10 mmi 2 iit M 121 EC IE RID LB IE RID ELPBE E wer Mess 47 05 a E wee Mes CI ii a Chack Mara Fea Erc rar HI 43 Ched mra Fea Erc irar HI 43 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 RTO LEE in n0 iu 5 130 ow Vanhrabcon Dit owed iC LES Ciel i md TI SM al 121 DA TC Hit Le Chers Ferr Faber enm eL 27 1 F Dreck Tire Fc Drit irena
28. ace The standard Docking Station has 4 loggers input channels The temperature measurement range of wireless data loggers 1s 50 C to 150 C The system will be validated based on the temperature range available on customer s site could be from 60 to 150 C with a total system measurement accuracy of 0 1 C for all range of measurement XpertLog System was designed to easily use for verification or calibration a temperature block or oil bath manufactured by Lives International or Hart Scientific This modular design allows for fully automatic sensor verification or calibration as well as multiple calibration or qualification equipment configurations Based on the use of high accurate RTD the system does not requires calibration before running validation studies but can use verification of specifications by the customer XpertLog software is designed to run on Windows 95 98 2000 NT or XP and provides everything needed to perform validation testing Using XpertLog software a system administrator creates user accounts and assigns user IDs passwords and access permission levels that identify the person operating the instrument and prevent unauthorized operation Validation study setups which include calibration criteria are programmed using XpertLog Software and can be run in standalone mode or under PC control The XpertLog also provides encoded secure data files that prevent modification of the original data and includes data reporting option
29. alculation XpertLog System XpertLog Data Loggers uncertainty under worst case Temperature C Calibration Uncertainty at k 1 C Calibration Uncertainty at kz2 C Please contact factory for detailed calculations Em User s Manual rev 1 2 August 2007 XpertLog 4 2 XpertLog Technical Specifications Technical Specifications Loggers Temperature Pressure Humidity Range Temperature amp accuracy Pressure Humidity Material Battery Leak free Data collection interval Memory Internal watch accuracy Weight Calibration PT 100 4 wires High accuracy 0 5 bar absolute Capacity 60 150 C continuous 0 1 C 80 100 C continuous 0 1 C Extremes no shield 175 C limited time with shield 110 C 340 C 0 5 bar absolute 5 mbar 20 90 RH 2 RH Ketron Peek FDA compliant Lithium user replaceable IP 68 1 second to 24 hours 16 000 data points 1 second month 35 40 or 70 g battery included COFRAC NIST traceable ITS 90 coefficients included Specific applications 1 80 C freezers continuous operation 80 C for one week cycles no thermal shield needed 2 sterilisation tunnels standard operation at up to 340 C for 10 minutes requires thermal shield and standard cooling zone does not apply to heat ovens 250 C for several hours
30. atus between the data loggers the temperature standard the temperature block and the computer For each equipment 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 Reference Probe Different types of reference probes can be used for calibration IQ RTD smart probe IRTD A Hart reference probe from Hart DTI SI RTD from Ametek Lives Int regulation probe of the Lives model ATC temperature block Lives Ext reference probe Lives connected to front panel of the block Lives model B The new concept introduced by XpertLog is the temperature block controlled by the reference probe when using Lives probe and flexible wire data logger The minimum requirements in order to take advantage of this option is to use the reference block Lives ATC B Series This type of blocks have an external input for the Lives reference probe so this probe could be configured to control the block the regulations of the temperature block will be controlled by the reference probe Prior to operate this option you have 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 oe ee User s Manual rev 1 2 August 2007 XpertLog 3 2 2 Setup Administration rem E ce pe lema Pee 2 E DESI rebos RT
31. ble click and define the level allowed for the action allow setup without retrieve enable or disable the option create Off line Tests double click and define the level allowed for the action allow calibrations enable or disable the option export import tests double click and define the level allowed for the action export import verif and calib double click and define the level allowed for the action create statistics double click and define the level allowed for the action design reports double click and define the level allowed for the action save reports double click and define the level allowed for the action review reports double click and define the level allowed for the action allow to review own reports enable or disable the option show action hints enable or disable the option logon required to end calib verif test and reset test enable or disable the option activate battery replacement warning enable or disable the option activate calib date warning enable or disable the option Security features Allow setup without retrieve if this option is enabled the loggers would be able to be programmed without retrieving the data It is strongly advised to disable this option in order to avoid data destruction before retrieving data in the data base Members Create new members on 4 different levels The administrator has the ability to modify the password change interval and the password minimum
32. ct at 121 1 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 1s 10 C 18 F This is based on experimental observations for Baccilus Geostearothermophilus a highly heat resistant organism ado iss User s Manual _ rev 1 2 August 2007 XpertLog 3 2 5 Action Equipment Info XpertLog 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 Equipment Info Click on Listing to display the report of all equipment defined EL im ILLE brut hho aoe Eeport Priye fr ux 8 0 Close the window to return to main menu 27 ue User s Manual rev 1 2 August 2007 XpertLog 3 2 6 Action Calibration Calibration was defined as an option for the user in order to calibrate the loggers if they came to be outside the specifications defined by the user Calibration menu is available if the appropriate option have been enabled in Administration 1o Leg LAL admis Publrmimnistratar Calera Two types of calibration are available Offline calibration
33. e loggers will be blue 1 AT User s Manual rev 1 2 August 2007 Refresh loggers and retrieve data from the available loggers As the loggers have more recent data then existing in the data base the software will try to recover all data Acknowledge to recover data Data can not be stored in the data base because part of data from the loggers have been saved hares XpertLog Dreninading 151 Logger have more recent data than in in a test QD Corinne colecing Case 3 data is downloaded from loggers before stop time and logger is switched to idle If user want to download data before stop time he will need to stop the loggers and retrieve data Refresh loggers then click on the first logger in the list click then on switch to idle to stop collecting data _ 48 seu Loggers are collecting data data have not been downloaded User s Manual _ rev 1 2 August 2007 Compile data from loggers After data has been downloaded they need to be organized in reports XpertLog allow users to organize data in reports In order to do this user needs to open Test compile Data downloaded from the loggers are organized by Click on start time to visualize data that user can choose from start time download time logger setup by by tests CUE EEE EEL CPE EPETT TLE EELELLLEEEELELL 49 4E ub xbodh E ud LES uH SE E uH ouo ome D ces aho comes wo xA co cms amd mA ce cms md 1 i i
34. e type of report Adobe Acrobat Document pdf enter for the name of the file in the PDF Export Options choose Export Image Format as JPG disable Export Frames click Ok 2 xls click on X icon to save report as Excel file choose the path to store the report C do not change the type of the report Excel Files xls enter for the name of the file Excel will automatically open the report as a Excel file Using the same procedure user can save reports also as report file frp text file txt rich text file rtf html file htm csv file csv bitmap file bmp 31 User s Manual rev 1 2 August 2007 XpertLog Export calibration report Close then right click on the calibration report The options delete export and linked objects will be visible Click on Export in order to export the calibration report Define the location where to store the calibration report by clicking on the small icon next to the path I Define location aidiz Laport Cobb Calbrateon 90 et 130 avec v rification amp IUD OS CE Expo bor He wed be created XxLag 0 Geeky 1 cb 4 lierre in apari 1 Information x e A Export completed M E Calibration 90 et 130 avec v rification 100 Calibration epit bor O D 2 2005 a 248 Mee apart 2 Calibration report to be exported will be displayed with all its extensio
35. ed it is strongly recommended that the block and the probe be calibrated together by a Lives International calibration service The serial number of the probe must be entered in the block by the calibration service together with the correction coefficients for the probe The verification of the equipment in the software allows users to be aware if the serial number of the probe does not corresponds to the serial numbered recorded in the block Lives International declines all responsibility in case of incorrect use of probe connected to the temperature block 2 2 Different XpertLog Models Temperature RTD probe case mount extended RTD probe teflon coated 18 inch 50 mm extended RTD probe kapton coated 18 inch 50 mm Ultra Low Temperature High Temperature for Sterilization Tunnels Temperature and Humidity Temperature and Pressure 2 3 Minimal Configuration of XpertLog Validation System Minimal configuration of XpertLog validation system Data Loggers Lives XpertLog Temperature Reference Probe Lives connected directly to the temperature block or Hart probe with display Temperature Block Lives XpertLog validation software PCMCIA card with 2 or 4 communication ports PC laptop or desktop with Pentium III processor 1 5 Ghz 256 MB SDRAM Hard Drive 20 Go OS Windows 95 98 NT 2000 Xp Vista User s Manual rev 1 2 August 2007 XpertLog WARNING The computer to be used with the system need
36. hality using Ty 121 1 C and Z 10 C D The D value of the microbial population Choose the F Config module from the main menu Choose the study type steam dry heat with or without depyrogenetion Define the Z value and the reference temperature value for F calculation Define the minimum temperature from which the F Value will start accumulating EL P w D Dp Has e iban CI een w D Dig eene ark Doer w D Zoe LC bi tence Zw LC LT gm om 2 vate iti T tence Ta fan FT 1710 H Tz Tara C 170 a Tp Tang FE 2251 3 ie bin Teo To Cak F Y T TU bin Teo To Ca F v T 1503 i bh TD To Co False T zu 3 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 20 User s Manual rev 1 2 August 2007 XpertLog The F value used to evaluate the efficiency of a sterilization process is the time necessary to produce a certain sterilization effect F value is defined as the time in minutes to produce the equivalent sterilization effe
37. he hard disk during normal operation of the PC Insert installation CD in the computer and double click on Setup exe After the Setup Box follow the instructions displayed on the screen for choosing the directory in which XpertLog will be installed Cf dej biet alm weed nm il Ther Ded giten E cord pall incidi pero cr eur conter Te corde eh Hes ka am bed sd rure pred t iun Led beret du euin pod ic Lorm e ia rarioa acad clac robe ad Lie Inter ae br o npa ran uda prim tH hr on perrito m und T al rab price Bye DRa seal yu ages bae band ky LE Db tva aid WET Ti perg ok 4 parties Be opns ees nac ETT rrj biet ale week imo ad Click Hac ba metal bo H n Polar or chek Change ta ial bo a dwari Haidar Tec progres From ema US oem beers ed ale ENEREENERERERERRERERERERRERERENE User s Manual rev 1 2 August 2007 XpertLog TETI I Jors eel IT rl xl Input serial number dosette irar Crarmpsiet nd Tha raati Wierd han maccamhuley iracalac part pa EE Fr iz at the rom EZ Laure Pn imam Click on Finish to start the software enter the name and the serial number XpertLog icon is automatically placed on the desktop Warning this is a case sensitive window enter the name and the serial number as written on the CD s label Uninstall XpertLog Insert the installation CD and double click on Setup exe follow the instructions displayed step by step Yr NEC S Bla ge aA Mp fL
38. ification click on Setup Loggers and then remove them from the station To program more loggers then slots available in the station insert the loggers which are not yet programmed in the station then click Refresh loggers and Setup loggers as many times as needed to program for verification all loggers When clicking on Setup loggers a warning message will appear to inform the user that all data stored in the logger will be overwritten choose Yes to proceed When loggers are programmed for data acquisition the icon corresponding is clock blank ampoule LP SU User s Manual rev 1 2 August 2007 XpertLog Click on Assign Calib to define the calibration report to whom the verification is reported By default the last calibration file is assigned but the user has the choice of different calibration report to be assigned or to assign no calibration report at all without calib Arog Laki por cab 2 PEERS 13 CS dn Meggan brhearedges GL TEXTS Lis iac MU i Fii m mo EL P Dn in Calais DEAEUUS 20184 DA Les Lain anco CH Lre Caiieeabon RAS Arch w Lis irs Cultes ee ee ee ET Z1 DES After assigning the calibration report click on Step completed to go forward A warning message will appear informing users that the setup of the loggers was completed and loggers should be transferred to the temperature source e g oil bath After the
39. length tartan Lac D aiabaos M ES Password Change Interval 40 Days qo Ce u 4 Password Minimum Length chars Faremi Charge nel 3 Ds m Fareed hiner Leng PITE m Create a new member A Click on the level needed to create new entry Click on New Member Lagen Boots Level Define ima i einn no Login LE Lie Name enter full name ad Hepara Password ES TUNE han des Haie mast change passeced a ned spon User s Manual rev 1 2 August 2007 XpertLog Retype password Redefine the access level Click Ok to acknowledge creation of new member The option 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 Berre hl als ier Location CMM dela dd uaria E XD BF Pe EEE FC D dna E es v Lngn Fiaquaeci iz Liu Hear Dad aba D Hanoran v Mowe ko uec database an dis E Ree TTC Coste Hra LI E aaa Ws A 3 Auda Mana Fomai le Bache Database af tips Evi B Te Compact Daraus al App Lait IB Lab ELIT EIFE I T mE Rm au Audit
40. loggers have been transferred to the temperature source click on Step completed the verification will start the oil bath and the reference probe are controlled by the software during verification changing from one set point to another is performed automatically by the software When verification is ready the software will request user to enter the verification name and hit Ok Rie Ceri akin Venbcsbon H Line CE User s Manual _ rev 1 2 August 2007 XpertLog Insert the first set of loggers in the docking station and click Ok the software will search for loggers presents in the station T 4 OI LOC EAU x In this case place the loggers in the reader and click Refresh Loggers and Retrieve data After data from all loggers were downloaded the message All required data downloaded appears Click Ok close then open Verification to refresh the list of calibration reports Double click on the verification report to open it The report will display the temperature value of the reference probe and the error of each logger versus the reference kkddddd ETTITIT E m He Eh Eb bh CETTE goo e ie LE eue E E E E ri E Ex am mmm aga ahi aga 20635 User s Manual _ rev 1 2 August 2007 XpertLog On line verification This type of verification can be used when the number of loggers to be verified is les
41. ns user may enable or not the saved calibrations in order to be exported with the original calibration report Click on Export in order to store the calibration report in the defined location After the export was effective the Export completed window will be displayed Import calibration report The calibration report can not be imported in the same data base from where it was exported User can only import it in the different data base In order to import a calibration report return to main menu then in Action click on Import All the available reports for import will be displayed Choose and double click on the calibration report you want to import then click on Import Close the window The calibration report will be imported in the data base Eu 0 0 0080808080 0 MM LLLZET IL import CoL ng Db cali Locher 2 x Reg dom Loc n Gif Ok Bera iint 1 impen ica T Tier Mrr Bieter Dei Lake ES Cabra KE ad 12K aee abris mac TER E J talon Pa dur Hrer QUOTE H liot Bret Fiore _ Hip lions Fihan ds t9 Fall uei da z Close the window and open Calibration menu The imported calibration report is added to the list of calibration reports with a small T red icon sa User s Manual _ rev 1 2 August 2007 XpertLog le ANE admin Administrar C alibratins PT Delete calibration report Right click on the calibration report The options delete
42. nt EET OT DOM ER err TUE ES be ur DRE 135013 Exc er Define Start Time Stop Time Interval then Setup loggers for acquisition Interval can be from 01 sec to 23 59 59 hours amp If any calibrations available the user can mmm Pre O choose the one he needs By default the last Combe IF Loges for n cin EEN bp Sain Ha calibration is displayed miter ogg Double click to choose a calibration file DEDOS e Gomis Hains User can choose no calibration at all 45 User s Manual rev 1 2 August 2007 XpertLog Click Ok to setup loggers for data acquisition Loggers will be setup and start data collection Memory capacity of the loggers is 16000 data points Loggers can now be taken out from the station and placed in the equipment which need to be validated At any moment loggers can be replaced in the station and data read from the memory If the loggers have been read before stop time they keep on collecting data until the user will place them on idle or until stop time Data retrieve After data have been collected user can retrieve data from the loggers several cases are possible Case 1 loggers reached stop time data collection stopped Replace the loggers in the docking station for downloading data from memory From the main menu go in Test data retrieve the software will automatically scan for existing loggers Click on Retrieve data to download data from loggers If data need t
43. o be retrieved from more loggers then slots in the station download data from the first set of loggers then replace then with the next set of loggers click on Refresh loggers then Retrieve data Dosnloacng 234 12D of 121 Case 2 data is downloaded from loggers before stop time and logger is not switched to idle In this case the loggers will keep on collecting data after data is downloaded If the data downloaded from the loggers was saved in a test report then it will be impossible to download the rest of the data from the memory of the loggers 46 Loggers are collecting data data Loggers have been downloaded and have not been downloaded still keep on collecting data User s Manual _ rev 1 2 August 2007 XpertLog If the user will refresh loggers and retrieve data the software will warn the user that the logger has more recent data than in data base and will ask the user to replace existing data If acknowledged the software will download all data from the memory of the loggers and still keep on collecting data as they are not in idle Downloading 181 EST E NN If the user would close the window and go in test compile to store the data from the loggers the data will be saved as a report Today PATE Tem LL Fey eal Return to Loggers prepare the software will scan the station to find and display available loggers The icon corresponding to th
44. o refresh the list of calibration reports Double click on the verification report to open it The report will display the temperature value of the reference probe and the error of each logger versus the reference x9 User s Manual _ rev 1 2 August 2007 XpertLog 3 2 8 Action Test Test menu is used to program loggers for acquisition and to download data from loggers after the tests Two types of test are available On line tests Off line tests On line test In Test menu click on On line Test to start a new on line test The software will search for loggers available and display them L a rer Gite M m Click Ok software will display the calibration reports available for each logger user can use any calibration report available or use no calibration report at all By default the last calibration report will be available Click Ok to go to next step KL DILIG sirin Bee braber Test User may configure the F value acquisition interval virtual channels add info 39 User s Manual _ rev 1 2 August 2007 XpertLog F Value configuration Click on F Config to define the type of test and define if F value will be or not calculated Right click on the screen to select or unselect all channels or enable one by one the cases corresponding to the loggers to be enabled iF Valur Lang i E Valer Lang Ss i Click
45. omatically Display of data as values amp trends Introduce the concept of custom calculations Available reports Calibration reports Verification reports Test report Temperature values F values for penetration study Statistics Minimum values for each channel Maximum values for each channel Average values for each channel Trends Values The accumulated F values Intermediary reports during data Minimum data acquisition interval 1 sec Unlimited number of loggers to be programmed or read and stored in one report Label configuration of each logger before test starting Easy handling of loggers Raw data recorded in the loggers memory capacity of 16000 data points Stand alone units User friendly software Flexible software Software validation manual One day training after delivery IQ amp OQ Standard connectors and cables Control of other manufacturers equipment Hart temperature blocks and smart probe IRTD User s Manual rev 1 2 August 2007 XpertLog 2 XpertLog Equipment 2 1 Hardware equipment XpertLog validation system is composed by Data loggers XpertLog Temperature Reference Probe Lives connected directly to the temperature block or Hart probe with display Temperature Block Lives XpertLog validation software PCMCIA card with 2 extra communication ports Notice When the Lives temperature block B series is controlled through the Lives probe connect
46. on Config to define the type of sterilization steam dry heat with or without depyrogenation Test configuration Click on Test Config to define the acquisition interval start by time or by value Define loggers data acquisition interval 40 User s Manual _ rev 1 2 August 2007 Start on line test by time Click on By time and define start and stop time This feature is valid only for on line tests Click on Start Test and enter the name of the test XpertLog The loggers will switch to idle data will be displayed on the screen but not stored in the report till the time defined by the user Then loggers will switch to data collect and start collecting data in the report When stop time defined by the user is achieved the test will automatically stop Close and open test to refresh tests list and display the report which was performed CLOLTS 1230713508 ruris PLUS CE dT IUe unn AES CF didt am 41 j enrweueos User s Manual _ rev 1 2 August 2007 XpertLog Virtual channels Use has the ability to insert his own calculations which will be displayed as separate channels in test report Examples of calculations ULL x Maxval max 234 265 MinVal min 234 265 Delta max 234 265 min 234 265 The test report will automatically have three extra channels MaxVal MinVal and Delta Add info This menu is used for adding commen
47. s 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 Internal memory of XpertLog data loggers contains 16 000 00 sixteen thousands data points XpertLog is designed to write data to internal memory and PC hard drive if connected during sensor verification calibration and qualification Calibration Verification and Qualification data is recorded to the internal memory in real time Data loggers are powered by a internal battery which provides between 3 month and 1 year data logging XpertLog system is designed to operate with the Lives STS series temperature reference probes connected to Lives ATC series temperature block or Hart probe model 1502 or Kaye IRTD and the Lives ATC series or Hart temperature blocks or cryogenic oil bath The equipment provides NIST traceable calibration of thermocouples used in thermal validation studies with a range of 60 C to 150 C During calibration and or verification XpertLog automatically reads and monitors the temperature of the reference probe For loggers calibration the reference probe functions as the standard for correcting thermocouple readings The Temperature References provide highly stable temperature conditions for sensor verification and or calibration and respond to pre programmed calibration criteria allowing automatic loggers calibration at
48. s or equal then the number of slots available on the docking station and the type of loggers to be calibrated is with flexible RTD In this case the verification equipment can be oil bath with reference probe or dry block with reference probe Procedure In Verification module click on On line verification the loggers and the equipment used for verification are displayed on the screen Click Ok the available calibrations to be assigned to the verifications will appear on the screen Choose the one which will be assigned to the verification The user has the choice not to assign any calibration to the verification which is going to be performed Click Ok the on line verification screen will appear click on Verif Config to modify verification configuration PAR INC eg Som Hae HET Tiy Sois HA PSA Td by om Hp A 2350 6 ev Se Hd ETEA 1 CH CU by iam Hans heal Co ET Er sis ere m Click on Start Verif to start the verification Name the verification then hit Ok button are User s Manual _ rev 1 2 August 2007 XpertLog The verification will start drift will be first verified once the drift was verified and found within the specifications defined by the user the calibration will start 3 F Ped iru i When on line verification is ready the message Verification successfully completed will appear Click Ok in order to save the verification report Click Ok close then open Verification t
49. s 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 2 4 Hardware configuration I Configuring data loggers for Com port operations Insert Lives data loggers in the docking station Power on and connect the docking station to the computer using a null modem cable The Baud rate is automatically chosen as 38000 baud II Programming the S N of HART 1502 display Connect the Probe to the module 1502A and power on the display 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 1 Flow control none then File Properties Parameters ASCII configuration check the 2 upper boxes in the window send EOF and locally write the characters e Enter the request SN in order to display on the computer s screen the serial number of the module e Check the serial number displayed on the screen with the serial number physically labeled on the module
50. ts in the header of the report Start On line Test hem beet Click on Start Test to start the on line test Enter the name of the test and click Ok to start The values for each logger will be real time displayed Also the values for the virtual channels will be displayed User s Manual _ rev 1 2 August 2007 XpertLog During the on line test user is able to display intermediary report trends statistics To visualize the intermediary report click on Report Faite ii je i ije i 1 titi v LE ERN T uvupgEPUETIFEEBA4E inu HTLTTEHTTTITITTTITITITIT HHHHIBHHHIHHBHNN HHHHEHETHEBHHIHHIH mom pun BR GS fmm omm EE To visualize the trends click on Trend Statistics are calculated from the beginning of the test to the first reset between two consecutive resets and between the last reset and the end of the test Click on Reset to reset the test and create new statistics Warning message will appear acknowledge to go further f E Let i Open again statistics to visualize statistics from the start of the test to reset 43 User s Manual _ rev 1 2 August 2007 XpertLog To stop the test click right upper corner 44 User s Manual _ rev 1 2 August 2007 XpertLog Off line test This is the most common usage of XpertLog data loggers Click on Logger Prepare to define start time stop time and data acquisition interval tort qup vie
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