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M4350E, rev. C.book - GE Measurement & Control

1. Figure 105 New Group Window 5 The Select Users window opens Figure 106 below Click on the Advanced button Select Users Select this object type Users or Built in security principals Object Types From this location GESENSING PC Locations Enter the object names to select examples Check Names Advanced OK Cancel Figure 106 The Select Users Window Kaye Validator User s Manual 159 Appendix A Installing Kaye Validator on the Windows Vista Operating System A 3 Adding the GE Sensing User Group cont 6 In the expanded window Figure 107 below click the Find Now button From the Search Results select User Account and click OK Select Users me Select this object type Users or Builtin security principals Object Types Erom this location GESENSING PC Locations Common Queries gt Search results Name RDN In Folder KE DIALUP HR Everyone P GE Sensing GESENSING PC By Guest GESENSING PC BB INTERACTIVE BA IUSR BE LOCA SERV Figure 107 Expanded Select Users Window 7 At the Select Users window Figure 108 on the next page click OK 160 Kaye Validator User s Manual Appendix A Installing Kaye Validator on the Windows Vista Operating System A 3 Adding the GE Sensing User Group cont Select Users neon Select this object type Users or Builtin security principals Object Types
2. The password expiration requirement can be set from 1 to 366 days with the spin buttons Click the spin buttons once to move in 1 day increments or click and hold to move in 10 day increments 8 Once your site options have been set click on the Preferences tab The Preferences screen appears as shown in Figure 26 below System Administration Site Options Policies Preferences Line Frequency Pressure Units 60 Hertz Bar 50 Hertz Celsius O Fahrenheit Temperature Units E Reporting F Allow users to change Lethality Criteria Company Name COM Port GE Industrial COM1 M Data Directory D RFYalprobe Passwordand4uditUtilities Backup Figure 26 The Preferences Tab in the Site Options 52 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 3 16 Establishing Site Preferences The Preferences tab has the following settings that can be initially set for all users who install Kaye Validator software from the network Select temperature units Celsius or Fahrenheit for all temperature calculations e Select the line frequency 60 Hertz or 50 Hertz Select the absolute pressure units for saturated steam calculations If you selected Other enter the value of 1 Standard Atmosphere in the absolute pressure units you are using e Allow users to specify the lethality criteria for calculation in repor
3. 5 2 16 Starting the Qualification Study Manually If you have specified Manual as the start qualification condition in your setup you have to login to the Validator and start the qualification study manually To start the qualification study manually 1 Press the Security Key The System Login screen shown in Figure 59 on page 98 displays 2 Key in your user ID and press ENTER 3 Key in your password and press ENTER The Password Operations screen shown in Figure 60 on page 99 displays Note Jf the start qualification event has been defined as automatic the Start Qualification option is replaced by the Auto Start of Qualification option See the previous section Starting the Qualification Study Automatically for more information 4 Press Start Qualification The Sensor Inputs Real Time screen displays 102 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 2 Viewing Real Time Sensor Readings Calculations and Events You can view real time sensor readings and real time calculations for each group defined in your setup You can also view real time events that apply to the whole study start stop qualification start stop exposure as well as all group specific events The first screen displayed when qualification starts is the Sensor Inputs Real Time screen This screen displays real time sensor readings You access all real time calculations and events defined in your setup from this scre
4. A 1 Turning Off the UAC cont 3 Click on User Accounts or Turn User Account Control UAC on or off Acknowledge the Microsoft warning by clicking on Continue The screen shown in Figure 100 below opens Turn on User Account Control UAC to make your computer more secure User Account Control UAC can help prevent unauthorized changes to your computer We recommend that you leave UAC turned on to help protect your computer Y Use User Account Control UAC to help protect your computer l Cancel Figure 100 User Account Control Screen 4 Uncheck the Use User Account Control UAC to help protect your computer box and click OK A prompt window Figure 101 below opens Microsoft Windows You must restart your computer to apply these changes Before restarting save any open files and close all programs Figure 101 Restarting Screen Click Restart Now and log in as the Administrator again Kaye Validator User s Manual 155 Appendix A Installing Kaye Validator on the Windows Vista Operating System A 1 Turning Off the UAC cont 5 There is a known Microsoft issue with running hlp files on Vista In order to be able to use the Online help with the Validator Software go to the Validator CD and run the Windows6 0 KB917607 x86 msu file by double clicking on it or selecting the file and opening it The Vista operating system has the appropriate Windows Update Stand alone Installe
5. Disabling disk recording also disables the rewrite report to disk function e When a loaded setup is set to not record to disk the disk recording disabled icon displays on the Validator instrument s display screen Disable the password system User IDs and passwords will not be required to use the software Note Ifyou select this option the Kaye Validator system will not enable compliance with 21CFR Part 11 requirements for electronic records To restore this option return to the Windows Start menu and click on Programs gt Kaye Validator gt Site Defaults Display User ID during entry By default the user ID is shown to the user when logging in Clearing this option will replace the user ID characters with asterisks Kaye Validator User s Manual 51 Chapter 3 Installing the Software and Creating User Accounts 3 3 1a Setting up Site Options cont 7 Click the check box next to any option that you want to enable An X appears in the check box when the option is enabled Click the check box again if you want to disable it The check box will be blank If you enabled the Allow timer for User ID entry option the Time Interval readout displays to the right of that option and the timer is initially set to 5 minutes You can set the timer from 1 to 15 minutes using the spin buttons e If you select the Require minimum length password option use the spin buttons to set the requirement from 6 to 16 characters
6. Event Messages Qualification Study Time 0000 01 30 Exposure Cycle Time Not Started gt 05 Mar 2005 Wed 14 41 05 Qualification Started QUAL 1 Main Menu Figure 64 Event Message Screen The Event Messages screen displays the qualification study time the elapsed time since the beginning of the study the exposure cycle time the qualification start event the exposure cycle start and stop events each occurrence of all group events that have been triggered during the study and the stop qualification event The time stamp date and time of each event is displayed above the event 3 Press the right arrow key Kaye Validator User s Manual 107 Chapter 5 The Qualification Study 5 2 2 Viewing Real Time Calculations and Events cont The Statistical Calculations Real Time screen displays as shown in Figure 65 below Statistical Calculations Real Time Group Distribution Time Wed 14 42 05 VALUE Min 89 85 G2 Max 89 95 Avg 89 90 G3 S Dev 0 03 Max Min 0 10 G4 Max Avg 0 05 Avg Min 0 05 QUAL 1 Main Menu Figure 65 Statistical Calculations Real Time The Statistical Calculations Real Time screen displays the statistical calculations defined for the selected group and their values Statistical calculations are computed each scan based on all sensors in the group If you enabled the Location of Max or Location of Min selection when you defined your setup this screen also identifies the sensor loca
7. Ireland Sensing House Shannon Free Zone East Shannon County Clare Ireland Tel 353 0 61 470291 E mail gesensingsnnservices ge com An ISO 9001 2000 Certified Company www gesensinginspection com en about_us quality html www gesensinginspection com 2010 General Electric Company All rights reserved Technical content subject to change without notice M4350E Rev C
8. 0 0 0 cette eens 105 Real Time Sensor Events Viewing 000 ccc cette eens 103 Relative Humiditys std eee hada ates dai 151 Relay RMB oiea a ena a ia A Mahala A aA cbt aco cadet elas 19 Report Rewrite to Disks sensere pn raner aeeai en a ens 145 1146 Report Rewriting to Disk noana nsaan anenee 87 Return Policia a A eh eels E 186 RF ValProbe Return Pol tortas Da PA EEO A A aia 186 OI 185 RII Connector 2 03 0 dal 19 RED a ieee ta is ean E ed chat we eens hae Ag we wn eg EN 24 180 Kaye Validator User s Manual S Saturated Steam Real Time Soren 109 Saturation Pressure SAD ii AA a Ni eh ate Mere 109 Saturation Temperature Steam 00 0 eee n ene ees 109 Scanning Speed is car d a ea E A Gas RD Peele Os 150 Screen Contrast Setting 2 0 0 eect nent a n nee 34 Security Key eri ees prise ia aaa date 17 Sensitivity A deed cia bee Meee di eR ee as 150 Sensor Calibration esaeran e ee cee eee e tenes 11 Sensor Calibration Verifying 0 0 ccc eee een eens 141 Sensor Confirmations ti Le we Sel has 140 Sensor Confirmation rea 83 Sensor Definitions creen 92 Sensor Input Modules SIMS o ooooooooocococ teen teens 5 124 Sensor Inputs Real Time Screen 0 0 00 ccc eee ene nes 104 Sensor Mnstallati ici o O A E APs PIR tng SAN etna Beek Ie a N 32 Sensor Selection Screen o oooooro ron 81 1138 Sensors Calculating Deviation of Calibrated a a e bunts eels halt oa dde d
9. A A e ee en e en he eee a O 152 B Backup Battery il Dt A a o A al 22 194 Batteries Disposal ii ts 172 Battery Discharge tar ds dd tadas ds 22 Battery Pack Replacement o oooooooooorrrror nee nen n ees 23 Battery Recharge occ A A ead ec dba Gea 23 C Calculations and Events uta ds di ae as 116 Calibracion Michal a 4 hal alate oii a a a alaa 44 PE Controuled sc sisi ee A EA tie dae 71 Preliminary Steps ci ldo cet ned wk ead ae ee eee ed 72 Standalone ii taste Welle Meal ede ele on a aati a etl 71 Calibration Information Viewing 0 0 0 0 cece ete teen nes 37 Calibration Offsets Deletion of 0 0 0 0c ccc cece eee eee eens 84 Calibration Offsets Viewing 00 e eens 90 191 192 Calibration Verification 13 sce wee A RA Wg ane E Meee 11 Definition OF pose eh Me ied be aed Hees Eee BE Re A ea 131 Performing Standalone uta A Gaerne gedaan ae Pte ween 133 Preliminary Steps natin A Solin We atin ees be ee 132 Calibration Verification Screen 2 0 eee eee ene n nes 141 Calibration Warming cio eck thos wa sla plone eal ed was dps 51 Calibration Performing a Standalone 0 cece eee eens 73 Communications Port Selecting 0 0 0 ccc eee een n eens 66 Compensator Temp Coef 0 0 0 eet enn n eens 150 Contact Inputs Connecting 6 kee ene ence enna 29 CTR AO i pee heeded Ba paar A A eee eras 31 CIR 80 es scale ER AA bale a ENE Ra aes He Ra Pa SRS A 31 Current Transmitte
10. Data will not be written to a disk drive for PC controlled studies if the System Administrator has selected the Disable Validator disk recording site option See Setting Site Options in Chapter 3 2 2 2 Connection Ports The back of the Validator shown in Figure 5 below has ports for electrical and communication connections Each connection port is labeled with an icon representing its function The connection ports are defined on page 18 RJ11 for IRTD focal PC Serial Comm RJ11 for IRTD RJ11 for Temp Ref Parallel Printer USB Flash Drive Interface D USB Port Figure 5 Connection Ports 18 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 2 2 Connection Ports cont Table 1 Connection Port Explanations RJ11 Connector There are three 6 pin RJ11 connectors labeled with a temperature reference icon for connecting IRTDs and one Kaye temperature reference Note The Validator can accept data from only one IRTD at any given time USB Flash Drive Interface For USB flash disk insertion Output Relay There is one NO NC relay output labeled with a contact switch icon for signaling a PLC or other device Relay Rating 110 VAC amp resistive load 24 VDC 2 amps resistive load 110 VAC 4 amp inductive load 24 VDC 1 amp inductive load PC Connector There is one 9 pin D shell subminiature serial communications cable connector labeled with a PC icon for connectin
11. Figure 113 on the next page select Device Manager at the top left corner 164 Kaye Validator User s Manual Appendix A Installing Kaye Validator on the Windows Vista Operating System A 4 Installing the USB Patch for VISTA Systems cont Device Manager View basic information about your computer Windows edition Windows Vista Business Copynght 2006 Microsoft Corporation All rights reserved Upgrade Windows Vista System Oeil Rating m Windows Experience Index Processor Intel R Pentium R 4 CPU 3 00GHr 2 99 GHz Memory RAM 1014 MB System type 32 bit Operating System Computer name domain and workgroup settings Computer name Vista PC W Change settings Full computer name Vista PC Computer description Workgroup WORKGROUP Figure 113 Properties Window Kaye Validator User s Manual 165 Appendix A Installing Kaye Validator on the Windows Vista Operating System A 4 Installing the USB Patch for VISTA Systems cont 5 In Device Manager the USB appears under Other devices as an Unknown device Right click and select Update Driver Software Figure 114 below File Action View Help es DOI m el es e VISTA PC p Computer a Disk drives E Display adapters s DVD CD ROM drives etl Floppy disk drives E Floppy drive controllers Og Human Interface Devices tig IDE ATA ATAPI controllers Keyboards A Mice and other pointing devices amp Monitors H Network adapters iy Other d
12. From this location GESENSING PC Locations Enter the object names to select examples GESENSING PC GE Sensing Check Names Advanced Figure 108 The Select Users Window Cancel 8 In the New Group window Figure 109 below click Create and close all windows New Group Group name Kaye Validation Group Description Members GE Sensing Figure 109 New Group Window with Group Created Kaye Validator User s Manual 161 Appendix A Installing Kaye Validator on the Windows Vista Operating System A 3 Adding the GE Sensing User Group cont 9 From the Start menu go to Computer gt C Program Files Kaye and right click Click on Properties then on the Security tab Figure 110 below and on Users Click the Edit button and then check Allow full control and click OK Kaye Properties Security Previous Versions Customize Object name C Program Files Kaye Group or user names a Administrators GESensing PC Administrators Users GESensing PC Users 82 Trustedinstaller 4 m To change permissions click Edit Permissions for Users Allow Deny Full control Modify Read amp execute List folder contents Read Write Y For special permissions or advanced settings click Advanced Leam about access control and permissions Figure 110 Kaye Properties Window Configured to Allow Full Control
13. Press Continue and then remove the disk from the drive The USB flash or floppy disk contains the calibration report file Now that calibration is complete you can take the disk to your PC to generate a Calibration Report See the Validator online Help for information on generating a Calibration Report 4 2 4 Rewrite Report to Disk You can write an additional copy of the calibration report file to a USB flash or floppy disk using the Rewrite report to disk option To rewrite the calibration report file to a disk 1 Insert a USB flash or floppy disk into the appropriate Validator drive 2 Press the blue security key Enter your user ID and password on the System Login screen The Password Operations screen shown in Figure 52 below and Figure 53 on the next page displays Password Operations Load Setup Calibrate Sensors Start Qualification Select USB Disk Storage Rewrite Report to Floppy Main Menu Figure 52 Password Operations Kaye Validator User s Manual 87 Chapter 4 Calibrating Sensors 4 2 4 Rewrite Report to Disk cont Password Operations Load Setup Calibrate Sensors Start Qualification Select Floppy Disk Storage Rewrite Report to USB Disk Main Menu Figure 53 Password Operations 3 Press Rewrite Report to Disk The Validator copies the calibration report file to the disk While the file is being saved the green indicator light on the drive is lit After the calibration report file i
14. The Validator allows you to scan data at one of two rates during the qualification study 8 inputs per second or 12 inputs per second Each rate has a maximum file rate that is automatically determined based on the number of sensors being sampled as shown below For further information refer to the Validator Online Help topic Data Storage Rate The maximum file rate for an 8 inputs second scan rate is determined as follows Number of Sensors Maximum File Rate 1 8 1 0 seconds 9 16 2 0 seconds 17 36 5 0 seconds The maximum file rate for a 12 inputs second scan rate is determined as follows Number of Sensors Maximum File Rate 1 12 1 0 seconds 13 24 2 0 seconds 25 36 3 0 seconds Kaye Validator User s Manual 21 Chapter 2 The Validator Hardware 2 2 4 Internal Memory cont IMPORTANT If 8 inputs second is selected the file rate for 17 36 sensors is 5 seconds due to overhead processing When you create a setup you select the file rate from a list of valid rates If you choose to write data to internal memory at the maximum file rate the internal memory can fill up quickly When data is deleted from internal memory data already stored to disk or printed is not affected however the amount of data that can be downloaded to disk at the PC after a standalone qualification study has ended may be affected 2 2 5 Backup Battery The Validator is equipped wi
15. cont 6 2 3d Calibration Verification Complete When calibration verification is complete the System Message screen displays as shown in Figure 93 below System Message MESSAGE TIME 13 Apr 2005 Tues 10 49 51 MESSAGE LEVEL Warning Continue MESSAGE DESCRIPTION Floppy Disk Recording Complete Figure 93 System Message Screen IMPORTANT Do not remove the disk until you acknowledge that the disk write is complete by pressing Continue If you remove the disk before the disk drive light goes out you may lose data 2 Press Continue and then remove the disk from the drive The disk contains the calibration verification report file Now that calibration verification is complete you can take the disk to your PC to generate a Calibration Verification Report See the Validator online Help for information on generating a Calibration Verification Report 144 Kaye Validator User s Manual Chapter 6 Calibration Verification 6 2 4 Rewrite Report to Disk You can write an additional copy of the calibration verification report file to a USB flash or floppy disk using the Rewrite Report to Disk option To rewrite the calibration verification report file to a disk 1 Insert a USB flash or floppy disk into the appropriate Validator drive 2 Press the blue security key Enter your user ID and password on the System Login screen The Password Operations screen displays as shown in Figure 94 below and Figure 95 on the next page
16. menu and navigational for standalone operation and a floppy disk drive Each of these is discussed below Display Screen Menu Keys Navigation Keys Security Key Floppy Disk Drive Figure 4 The Kaye Validator 2 2 1a Display Screen The 12 line monochrome VGA displays data in text only mode If there is more data than can be displayed on the screen you will see an up and or down arrow at the bottom of the screen Use the up and down navigational keys on the Validator keypad to scroll through the next or previous page of data You can increase or decrease the contrast of the display screen as necessary See Adjusting the Display Screen Contrast later in this chapter for more information IMPORTANT To clean the display screen GE recommends that you use only a soft dry cloth Do not spray liquid cleaner on the screen 16 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 2 1b Security Key The security key the key with the lock icon prevents unauthorized access to the system You must press this key whenever you are going to take an action that affects the Validator such as e Loading a setup e Calibrating sensors e Starting and stopping qualification Starting and stopping exposure When you press the security key you are prompted for your user identification and password Once you have identified yourself to the Validator you can perform the desired action All user logins are recor
17. multiple chambers Test results are stored in secure data files that can only be accessed through the Validator software Generate easy to read spreadsheet formatted reports from a single protected file raw data is never modified Export qualification data to an Excel spreadsheet file Greater portability over other validation systems weighs 20 pounds and includes a carrying case Network capabilities allow multiple PCs to store data files to the same location and use one centralized database for user ID password maintenance Kaye Validator User s Manual Chapter 1 The Kaye Validator 1 3 About this Manual This manual is intended to provide overview information on the Validator instructions on getting started with the software and step by step instructions on using the Validator in standalone mode The first part of this manual provides an overview of the Validator hardware instructions for installing the software and creating user accounts and an overview on using the Validator software The second part of this manual covers using the Validator in standalone mode including calibrating sensors running qualification studies and verifying sensor calibration For complete instructions on PC controlled operation of the Validator and instructions on creating setups and generating reports see the Validator online Help The following is a brief description of each section of this user s guide e Chapter I provides an
18. 0 c eee cece eee eee 163 Kaye Validator User s Manual vii viii Contents Appendix B Environmental Compliance B 1 Waste Electrical and Electronic Equipment WEEE Directive A an s 171 B2 Battery Disposal ws jae nog hg ts Ata ig aA adie tA et Ati ts een tele 172 B 2 1 What do the Markings Mean 00 cece ccc cette eens 172 B 2 2 The Risks and Your Role in Reducing Them 00 0000 e eee eee 173 Kaye Validator User s Manual Chapter 1 The Kaye Validator Chapter 1 The Kaye Validator 1 1 Introduction The Kaye Validator is the latest generation in thermal validation systems The Validator is a standalone thermal validation system designed to meet new regulations worldwide for validation processes Combining GE s precision thermal measurement hardware and data storage capability with proprietary Windows based software the Validator satisfies your calibration qualification and reporting requirements When performing sensor calibration and qualification studies you can operate the Validator in standalone mode or with a PC attached A complete Kaye Validator validation system includes e The Validator instrument e The Validator software for Windows 2000 XP and Vista A notebook or desktop PC minimum Pentium 300 MHz with at least 256 MB RAM and Microsoft Office 2000 or XP and a printer that supports both portrait and landscape page orientation Up to three Kaye Sensor Input M
19. 162 Kaye Validator User s Manual Appendix A Installing Kaye Validator on the Windows Vista Operating System A 4 Installing the USB Patch for VISTA Systems The final step is to install the USB patch for VISTA 1 After you have installed the Kaye Validator software and connected the Validator to the PC via USB cable the screen shown in Figure 111 below will appear Click Cancel Found New Hardware Windows needs to install driver software for your Unknown Device Locate and install driver software recommended Windows will guide you through the process of installing driver software for your device gt Ask me again later Windows will ask again the next time you plug in your device or log on Don t show this message again for this device Your device will not function until you install driver software Cancel Figure 111 Found New Hardware Screen 2 From the Validator CD install the patch for VISTA USB support from the Vista USB Support folder 3 On your Desktop right click on the Computer icon and select Properties Figure 112 on the next page As an alternative you can go to Start gt Control Panel gt System and Maintenance gt System Kaye Validator User s Manual 163 Appendix A Installing Kaye Validator on the Windows Vista Operating System A 4 Installing the USB Patch for VISTA Systems cont z ad ie i seer A Figure 112 The Computer Menu 4 Inthe Properties window
20. 2005 Fri 14 32 44 Distribution Study John Doe 31 Apr 2005 Fri 14 02 25 y Main Menu Figure 41 Setup List Screen 6 Ifthere are multiple setups on the disk use the up and down arrow keys on the Validator keypad or the Next and Prev buttons on the Setup List screen to select your setup The pointer gt appears to the left of the selected setup 7 Press Load It takes a few seconds for the Validator to load the setup When complete the Sensor Inputs Real Time screen displays The next step is to select the sensors to be calibrated Kaye Validator User s Manual 77 Chapter 4 Calibrating Sensors 4 2 1 Selecting the Disk Storage To set the type of disk on which you will store data either floppy or USB 1 Press the Security Key The System Login screen shown in Figure 42 below displays System Login User ID gt Password Figure 42 System Login Screen 2 Key in your user ID and press ENTER 3 Key in your password and press ENTER 78 Kaye Validator User s Manual Chapter 4 Calibrating Sensors 4 2 1 Selecting the Disk Storage cont The Password Operations screen shown in Figure 43 and Figure 44 below displays To select the type of storage you need floppy or USB Disk press the Select Floppy or USB Disk Storage entry to alternate to the desired storage medium Password Operations Load Setup Calibrate Sensors Start Qualification Select Floppy Disk Storage Main M
21. 5 The Qualification Study 5 1 Introduction cont The Validator provides over 2MB of internal memory to maintain qualification data during a study Qualification data resides in internal memory until you power down the system Internal memory can fill up quickly during the qualification study depending on the length of your study and your data storage rate If the disk fills up and you do not replace the disk by the time internal memory reaches its limit you may lose data The program will inform you of this occurrence you choose whether to continue with partial data or abort the run See Specifying the Data Storage Rate in the Validator online Help for more information The Validator is also equipped with a NiCad backup battery to provide short term power in case of AC power loss during your qualification run The intent of the battery is to provide sufficient time approximately 30 minutes so that you can perform an orderly shutdown of the system When the Validator detects that the AC power has failed and the system is running from battery it issues a message and then disables the Validator display backlight You can momentarily re enable the backlight by pressing any key on the unit When the battery has approximately one minute of power remaining the Validator stops collecting data and closes its data files Note Jn the event of power glitches or short term drops in supply voltage brownouts there is a remote chance that
22. 67 Interval Summary Screen The Interval Summary Real Time screen displays the interval start time the group extremes minimum sensor reading of the entire group and maximum sensor reading of the entire group during the specified interval and the time duration of the interval Note Jf the interval calculation has not yet started dashes display in the VALUE column and Not Started displays in the TIME column 6 Press the right arrow key 110 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 2 Viewing Real Time Calculations and Events cont The Interval Minimum Real Time screen displays as shown in Figure 68 below Interval Minimum Real Time Group Distribution Time Wed 14 44 40 MIN 89 90 C 89 91 C 89 90 C 89 85 C 89 87 C 89 95 C TIME Wed 14 42 05 Wed 14 42 30 Wed 14 42 00 Wed 14 43 10 Wed 14 43 30 Wed 14 42 25 QUAL 1 Main Menu Figure 68 Interval Minimum Screen The Interval Minimum Real Time screen displays the minimum readings for each sensor in the selected group during the specified interval and the time the minimum reading occurred for each individual sensor 7 Press the right arrow key Kaye Validator User s Manual 111 Chapter 5 The Qualification Study 5 2 2 Viewing Real Time Calculations and Events cont The Interval Maximum Real Time screen displays as shown in Figure 69 below Interval Maximum Real Time Group Di
23. Cycle Automatically 118 5 2 5bStarting and Stopping the Exposure Cycle Manually 0 118 5 2 6 Ending the Qualification Study 0 ccc eens 121 5 2 6aEnding the Qualification Study Automatically o ooooooooooo o 121 5 2 6bEnding the Qualification Study Manually 0 000 cee ee ee eee 122 5 27 Rewrite Report to Disk A eRe CG A 124 5 2 8 Pausing Data Recording During the Qualification Study o oooo oooo oo 127 Kaye Validator User s Manual v Contents Chapter 6 Calibration Verification 6 1 gt Introduction a o do a o ea 131 6 2 Performing a Standalone Calibration Verification 0 ce eee eee eee eee 133 62 1 Loading a Setup s 22 5 ct e oi eee ie A a a a 133 6 2 2 Selecting Sensors ees ec A ss Ls oe eee hes Te Rona See ee Pets 138 6 2 3 Verifying Sensor Calibration 0 0 ees 141 6 2 3aCalculating Stability 0 cette eens 142 6 2 3bCalculating Deviation of Calibrated Sensors 0 0 c eee eee ee 143 6 2 3cData Logging Complete at Setpoint 00 cece cece eee 143 6 2 3dCalibration Verification Complete 000s 144 6 2 4 Rewrite Report to Disks 4 5 pti w eid agent pi a a ann ge N sR ads 145 vi Kaye Validator User s Manual Contents Chapter 7 Specifications 7 1 Total System Specifications sser si e a a E cette teen ene nes 149 72 gt Analog A A SA lo Adie BAe eA 150 RS col
24. GE Sensing determines that the damage is not covered under the terms of the warranty or if the warranty has expired an estimate for the cost of the repairs at standard rates will be provided Upon receipt of the owner s approval to proceed the instrument will be repaired and returned 186 RF ValProbe User s Manual Sensing OF CONFORMITY DOC 0018 Rev A We GE Sensing 1100 Technology Park Drive Billerica MA 01821 USA declare under our sole responsibility that the Kaye Validator to which this declaration relates is in conformity with the following standards e EN 61326 1 2006 Class A Table 2 Industrial Locations e EN 61326 2 3 2006 e EN 61010 1 2001 Overvoltage Category II Pollution Degree 2 following the provisions of the 2004 108 EC EMC and 2006 95 EC Low Voltage Directives The unit listed above and any ancillary equipment supplied with it do not bear CE marking for the Pressure Equipment Directive as they are supplied in accordance with Article 3 Section 3 sound engineering practices and codes of good workmanship of the Pressure Equipment Directive 97 23 EC for DN lt 25 A A Pea keynd f Billerica August 2010 Issued Mr Gary Kozinski Certification amp Standards Lead Engineer gt C TUV Customer Support Centers U S A The Boston Center 1100 Technology Park Drive Billerica MA 01821 U S A Tel 800 833 9438 toll free 978 437 1000 E mail sensing ge com
25. Sensors The Validator then calculates calibrated deviation The corrected results for each sensor are compared to the IRTD and logged and displayed every 30 seconds for the time period specified in the setup Sensors that fail the calibrated deviation evaluation are displayed in reverse video and marked as failed in the calibration report file Data Logging Complete at Setpoint When the Validator finishes logging the corrected results at the low setpoint it automatically sets the Kaye temperature reference to the high setpoint and repeats the calibration process When the calibration process is complete for the high setpoint the Validator automatically sets the Kaye temperature reference to the check setpoint The only difference between low and high setpoint calibration and the check setpoint is that calibration offsets are not changed during check setpoint Calibration Complete When calibration is complete the System Message screen in Figure 51 below displays System Message MESSAGE TIME 13 Apr 2005 Tues 10 49 51 MESSAGE LEVEL Warning Continue MESSAGE DESCRIPTION Floppy Disk Recording Complete Figure 51 System Message Screen 86 Kaye Validator User s Manual Chapter 4 Calibrating Sensors Calibration Complete cont IMPORTANT Do not remove the disk until you acknowledge that the disk write is complete by pressing Continue If you remove the disk before the disk drive light goes out you may lose data 2
26. Validator Setup Default Setup Date 28 Jan 2005 G1 Distribution G2 Penetration G3 Pressure G4 Contact Copyright 1998 2006 GE Sensing Main Menu Figure 14 Validator Screen 34 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 8 Setting the Display Screen Contrast cont To adjust the screen contrast 1 Press Main Menu from the Validator screen The Main Menu displays as shown in Figure 15 below Main Menu Real time Data Historical Data Setup Review Hardware Controls Figure 15 Validator Main Menu 2 Press Hardware Controls The screen in Figure 16 on the next page displays Kaye Validator User s Manual 35 Chapter 2 The Validator Hardware 2 8 Setting the Display Screen Contrast cont Hardware Controls Increase Contrast Decrease Contrast Pause Disk Pause Printer Engineering Log Home Figure 16 Hardware Controls Screen 3 Press Increase Contrast Decrease Contrast as necessary to adjust the screen display 4 Press Main Menu The Main Menu screen redisplays 36 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 9 Viewing Calibration Information Once your validation system is connected and powered on you can view calibration information for your Validator and your SIMs If you are using a Kaye IRTD and temperature reference you can also view calibration information for your IRTD and temperature reference To view ca
27. and comes with a soft case with a padded handle and shoulder strap A zippered compartment accommodates small items such as a manual or power cord You can order additional cases to carry your wire harnesses and accessories For shipping the Validator you ll need a safe and durable container GE can supply a rugged foam fitted case equipped with wheels and a collapsible handle to transport your Validator Two compartments include a secure space for the instrument and accessories such as SIMs and cables Contact the Sales Department at GE for pricing If you use another type of container make sure the Validator is padded on all sides with four inches of cushioning filler If you need to return the Validator to GE for service contact the Customer Service Department for a Return Materials Authorization Number before you ship Include the number with the instrument Kaye Validator User s Manual 45 Chapter 2 The Validator Hardware no content intended for this page proceed to next page 46 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts Chapter 3 Installing the Software and Creating User Accounts 3 1 Introduction Before using the Validator system you have to install the Validator software on your PC and perform some basic system administration tasks The Validator software includes a Password Maintenance utility that allows a user with System Administrator permission to c
28. correct a printer problem See Pausing Data Recording During the Qualification Study ater in this chapter for more information 5 2 1a Starting the Qualification Study Automatically If you have specified an automatic start qualification condition in your setup the Validator automatically starts the qualification cycle when the start qualification condition is met No action on your part is required Note When you start qualification automatically the trigger condition must go from FALSE to TRUE to be recognized For example a contact may be programmed to start qualification when CLOSED If the contact is initially CLOSED when a setup is downloaded it must cycle through OPEN and back to CLOSED to be recognized as a CLOSED event All other events are recognized whenever a qualification cycle is active and the condition is TRUE For example a contact may be programmed to start exposure when CLOSED If the contact is initially CLOSED when the Start Qualification event occurs the exposure cycle will start immediately Once the qualification study has started you can view real time sensor readings and calculations for each group in your study and view all study events and group specific events that occur during the study You can also view historical sensor readings calculations and events and review setup data These topics are discussed later in this chapter Kaye Validator User s Manual 101 Chapter 5 The Qualification Study
29. disk and in your PC s memory 7 With the secure data file loaded on your PC use the Validator software to design and 14 generate reports to document the specifics of your study You can choose from two report utilities Kaye Validator now offers Report Wizard a reporting utility that enables you to create setup calibration calibration verification and qualification reports and to export qualification data to an Excel spreadsheet file With Report Wizard you can edit the groups and sensors that appear in a qualification report select cycles change the layout of columns in the report and add comments As an alternative you can apply the basic reporting utility to generate the setup calibration calibration verification and qualification reports For qualification reports enhanced graphing capabilities allow selecting and removing sensors constants and calculations You can also control graph colors line styles and gridlines and insert relevant text and illustrations In both utilities you can access and print out the Audit Trail you can apply filters based on users dates Validators or serial numbers and specific events Kaye Validator User s Manual Chapter 2 The Validator Hardware Chapter 2 The Validator Hardware 2 1 Introduction The Kaye Validator comes equipped with a universal power supply a power cord for 115 VAC or 230 VAC as necessary over 2 MB of internal memory a 1 44 MB 3 5 inch floppy d
30. disk into the appropriate Validator drive 2 Press the blue security key Enter your user ID and password on the System Login screen The Password Operations screen displays as shown in Figure 78 below and Figure 79 on the next page The actual screen varies with the disk type used Password Operations Load Setup Calibrate Sensors Start Qualification Select USB Disk Storage Rewrite Report to Floppy Main Menu Figure 78 Password Operations with Disk Inserted 124 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 7 Rewrite Report to Disk cont Password Operations Load Setup Calibrate Sensors Start Qualification Select Floppy Disk Storage Rewrite Report to USB Disk Main Menu Figure 79 Password Operations with Disk Inserted 3 Press Rewrite Report to Disk The Validator copies the qualification report file to the disk While the file is being saved the green indicator light on the drive is lit When the qualification report file is saved the System Message screen displays as shown in Figure 80 on the next page Kaye Validator User s Manual 125 Chapter 5 The Qualification Study 5 2 7 Rewrite Report to Disk cont System Message MESSAGE TIME 10 Mar 2005 Thurs 16 059 19 Continue Disk Recording Complete Verification Status PASSED Figure 80 System Message Verification Screen 126 Kaye Validator User s Manual Chapter 5 The Qualificat
31. e Click Start on the Windows task bar and then click Run e Click Browse From the Browse dialog box select your CD ROM drive click Setup exe and then click Open 3 Click on the appropriate installation path to install Kaye Validator to your PC 4 Follow the on screen instructions to perform the installation 5 Once installation has completed the Kaye Validator Initialization program will run automatically The Kaye Validator splash screen will appear followed by the System Administrator Site Options screen as shown in Figure 3 1 on page 50 6 Select the desired System Administrator Site Options and Preferences as described on page 50 and click OK 7 Click Finish to complete the initialization program 8 Return to the Windows task bar Click Programs gt Kaye Validator gt Client Setup 9 Follow the on screen instructions to complete the installation Kaye Validator User s Manual 55 Chapter 3 Installing the Software and Creating User Accounts 3 4 Starting Kaye Validator 1 To open Kaye Validator for the first time click Start gt Programs gt Kaye Validator gt Kaye Validator A control box opens similar to Figure 28 below IM Kaye Yalidator Control No accounts other than the default Kaye account have been found with password administration access Do you wish to log in at this time ae Figure 28 Default Kaye Account Box 2 Click Yes The Identification Required dialog box shown in Figure 29 be
32. have all the facts 1 e an error budget that accounts for all measurement uncertainty Because sensor calibration is an integral part of validation total system accuracy should include potential error from the recorder as well as the temperature reference and traceable standard Since all component errors are additive to the total system few errors are insignificant A summary of the error budget for a Kaye validation system after sensor calibration with type T thermocouples used at steam and dry heat is listed below Validator 121 C 250 C Conformity Error 0 04 C 0 04 C A D Conversion Error 0 01 C 0 01 C Total Reference Compensation Error 0 10 C 0 10 C Total Validator Error 0 15 C 0 15 C Calibration Equipment 121 C 250 C NIST Traceable Temperature Standard Error 0 025 C 0 025 C Temperature Reference Transfer Error 0 10 C 0 20 C Total Calibration Equipment Error 0 125 C 0 225 C Total System Error 0 28 C 0 38 C Sum of calibration equipment amp Validator errors Kaye Validator User s Manual 149 Chapter 7 Specifications 7 2 Analog Input up to 36 7 3 Sensitivity 0 5 microvolts count on most sensitive range 7 4 Thermocouples Type T J K 0 1 C or F resolution J K temperature range 100 to 500 C T temperature range 200 to 400 C Type T premium 0 01 C or F resolution temperature range 121 to 400 C 7 5 Voltage Temp Coeffic
33. improper installation the use of unauthorized replacement parts or operating conditions outside the guidelines specified by GE Sensing the repairs are not covered under this warranty The warranties set forth herein are exclusive and are in lieu of all other warranties whether statutory express or implied including warranties or merchantability and fitness for a particular purpose and warranties arising from course of dealing or usage or trade RF ValProbe User s Manual 185 Return Policy Return Policy If a GE Sensing instrument malfunctions within the warranty period the following procedure must be completed 1 Notify GE Sensing giving full details of the problem and provide the model number and serial number of the instrument If the nature of the problem indicates the need for factory service GE Sensing will issue a RETURN AUTHORIZATION number RA and shipping instructions for the return of the instrument to a service center will be provided 2 If GE Sensing instructs you to send your instrument to a service center it must be shipped prepaid to the authorized repair station indicated in the shipping instructions 3 Upon receipt GE Sensing will evaluate the instrument to determine the cause of the malfunction Then one of the following courses of action will then be taken e Ifthe damage is covered under the terms of the warranty the instrument will be repaired at no cost to the owner and returned If
34. in Reducing Them Your participation is an important part of the effort to minimize the impact of batteries and accumulators on the environment and on human health For proper recycling you can return this product or the batteries or accumulators it contains to your supplier or to a designated collection point Some batteries or accumulators contain toxic metals that pose serious risks to human health and to the environment When required the product marking includes chemical symbols that indicate the presence toxic metals Pb for lead Hg for mercury and Cd for cadmium Cadmium poisoning can result in cancer of the lungs and prostate gland Chronic effects include kidney damage pulmonary emphysema and bone diseases such as osteomalcia and osteoporosis Cadmium may also cause anemia discoloration of the teeth and loss of smell anosmia Lead is poisonous in all forms It accumulates in the body so each exposure is significant Ingestion and inhalation of lead can cause severe damage to human health Risks include brain damage convulsions malnutrition and sterility Mercury creates hazardous vapors at room temperature Exposure to high concentrations of mercury vapor can cause a variety of severe symptoms Risks include chronic inflammation of mouth and gums personality change nervousness fever and rashes RF ValProbe User s Manual 173 Appendix B Environmental Compliance A AAA aan 174 RF ValProbe User s Manual
35. in one step To select sensors individually use the up and down arrow keys on the Validator keypad to position the pointer on the individual sensor and press Select An asterisk appears to the right of the selected sensor indicating this sensor is to be verified To select all sensors in one step use the up and down arrow keys on the Validator keypad to position the pointer on All Sensors and press Select An asterisk appears to the right of each sensor indicating all sensors are to be verified Note Ifyou select a sensor that failed sensor calibration that sensor will be marked as failed during calibration verification In Figure 89 below sensors 1 01 through 1 04 have been selected Sensor Selection All Sensors Criteria 1 01 Temp 01 1 02 Temp 02 Select 1 03 Temp 03 gt 1 04 Temp 04 Deselect Continue Main Menu Figure 89 Sensor Selection Screen 5 After you have selected the sensors to verify press Continue Kaye Validator User s Manual 139 Chapter 6 Calibration Verification 6 2 2 Selecting Sensors cont The Sensor Confirmation screen shown in Figure 90 below displays This screen lists all the sensors selected on the Sensor Selection screen Sensor Confirmation Reselect 1 01 Temp 01 1 02 Temp 02 Cancel 1 03 Temp 03 1 04 Temp 04 Run Calibration Run Verification Main Menu Figure 90 Sensor Confirmation 6 Ifthe sensors you selected are not the ones you want to ve
36. in the Validator online Help for more information The Validator allows you to perform a one point two point or three point calibration verification Calibration offsets are not changed during calibration verification When you start calibration verification the Validator computes the stability of the temperature sensors and the temperature standard at the specified setpoint according to the parameters defined in your setup When the temperature standard and all sensors pass the stability criteria the Validator logs the stability readings to the calibration verification report file Finally the Validator computes and logs deviation on the calibrated sensors for a specified time period If you are performing a two point or three point calibration verification the Validator repeats this process Kaye Validator User s Manual 131 Chapter 6 Calibration Verification 6 1 Introduction cont During the calibration verification process the Validator writes calibration verification data to the USB flash or floppy disk drive the PC hard drive if calibration verification 1s PC controlled and to the Validator printer if attached Ifa sensor fails calibration verification at the low high or check verification setpoint it is marked as failed in the calibration verification report file Note Data will not be written to the disk drive for PC controlled calibration verifications if the System Administrator has enabled the Disable Valid
37. password whenever they e Create modify or move a setup Change the setup stored in the Validator Calibrate sensors or verify sensor calibration Manually start or stop a qualification study or exposure cycle e Change preferences Whenever an action occurs that requires a user ID and password the user name associated with that user ID and a time stamp are written to the file along with a description of the action 8 Kaye Validator User s Manual Chapter 1 The Kaye Validator 1 5 3 Electronic Data Requirements The Validator is designed to help you meet the guidelines for electronic signatures as specified in FDA Regulation 21 CFR part 11 Electronic Records Electronic Signatures e Two levels of identification user ID and password e Uniqueness of each user ID Users create their own passwords User ID and password required whenever an action affects the security or integrity of the data e Electronic signature identifies the user and includes the date and time of the action e Ifthe data is tampered with the entire data file becomes inaccessible e Password expiration feature allows you to set a password expiration from 1 to 366 days e System Administrators can set a minimum password length requirement e Option to disable a user account if there are three consecutive login failures for the user ID Secure audit trail files provide a complete listing of events that affect the integrity of the Validator PC progra
38. source Turn the temperature reference power switch to the ON position Turn the Validator power switch to the ON position IMPORTANT SIMs are only recognized by the system when you power up the Validator If a SIM is disconnected after power up that SIM s sensors will be read as Open and no data will be recorded for that SIM To rectify this power down and power back up Kaye Validator User s Manual 33 Chapter 2 The Validator Hardware 2 7 Setting the Validator Time and Date When the PC first establishes communication with the Validator the current time and date are automatically transferred to the attached Validator No action on your part is required Refer to your Windows documentation for instructions for changing the date and time Note Ifyou change the time of day of the PC via the control panel on a Windows NT operating system restart the Validator PC program to update the time in the Validator 2 8 Setting the Display Screen Contrast Once your system is connected and powered on you may have to adjust the contrast of the Validator display screen IMPORTANT When the Validator is powered up the last display screen contrast settings are in effect If the contrast settings make the display screen unreadable press the left and right arrow keys simultaneously to restore the default settings The first screen that displays when you power on the instrument is the Validator screen shown in Figure 14 below
39. the user option buttons in the lower left are grayed out 1 Enter your name in the Name text box The name you enter here displays in the active user list User names must be unique Once you have added your name to the active user list you can never use the same name again Your name is associated with the user ID that you enter in step 2 You use your user ID and your password to log in to the Password Maintenance utility 2 Enter your new System Administrator identification in the User ID text box Your user ID can be any combination of numbers and characters up to a maximum of 16 A user ID may not be used by more than one active account 3 Enter your new System Administrator password in the Password text box Your password can be any combination of numbers and characters up to a maximum of 16 For security reasons it is preferable to use more than six characters or numbers 4 Enter your password again in the Confirm password field Kaye Validator User s Manual 57 Chapter 3 Installing the Software and Creating User Accounts 3 4 1 Creating Your System Administrator Account cont At this point you should maintain a copy of your user ID and password in a manner acceptable to your local security procedures You need both to log in to the Password Maintenance utility to access reporting and to move or delete files If you do not enter the correct user ID and password you will be denied access 5 Click OK The Main M
40. to the active user list You assign a unique user ID for each user and a temporary password The user will change the password when they first log in To create user accounts 1 From the Main Menu screen click Password Maintenance and log in as a System Administrator The Password Maintenance screen appears similar to Figure 32 below Note that the System Administrator account is the only user listed E Password Maintenance MA ts e Deae cr ESO System Administrator A Da Figure 32 Password Maintenance Screen Kaye Validator User s Manual 59 Chapter 3 Installing the Software and Creating User Accounts 3 5 Creating User Accounts cont 2 From the Password Maintenance menu select Users gt New User The Password Maintenance dialog box shown in Figure 33 below displays Password Maintenance Name Program Choice Ce User Kaye Validator C ValProbe Disable User Account Kaye Validator Permissions IV Setup creation IV Audit Trail view and print Y Qualification execution IV Preference Modification Sensor calibration execution IV Instrument Calibration IV Verily sensor calibration I Modify site options VV Create reports IT Move or delete studies E Password Maintenance Figure 33 Password Maintenance User Screen 3 Enter the new user name in the Name text box The user name is associated with the user ID that you enter in step 3 The user ID is used to identify
41. you are going to use for calibration go to the next section Selecting Sensors IMPORTANT When you load a setup with a different calibration signature calibration parameters and or temperature units than the setup currently in memory any sensors already calibrated will be marked as uncalibrated If you reload the original setup and you have not calibrated sensors using the new setup the offsets are restored and the sensors are marked as calibrated When you load a setup with a different line frequency than the setup currently in memory you must wait for the Validator to stabilize approximately 2 3 minutes before calibrating sensors or you may see invalid sensor data displayed You can also turn the Validator off and then back on and then calibrate your sensors To load a setup 1 Insert the USB flash or floppy disk that contains your setup into the Validator USB flash drive interface or floppy disk drive In addition to setup data the disk contains the user list and the machine ID of the PC that saved the file to floppy or flash 2 Press the Security Key When you press the Security Key the Validator reads the machine ID of the PC from the disk e Ifthe machine ID on disk is the same as the machine ID in internal memory the Validator compares the date of the user list on the disk to the date of the user list in internal memory If the user list on the disk is more recent than the one in internal memory the Validator r
42. you will need to change the password before you can exit the password entry box 66 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 7 Selecting a Communications Port cont The Preferences screen displays as shown in Figure 36 below Setup Not Selected Hardware Preferences Temperature Units Line Frequency Pressure Units Celsius 60 Hertz Bar Fahrenheit 50 Hertz Company Name COM Port Authorized User IRTD Stability Threshold Machine ID Qualification Reports Lower limit 1225450702 400 JE Alternate Merge ValProbe studies 1225450702 a x Report Wizard Data Directory W Program Files 4pril Vista BACKUPS OffLine Figure 36 The Preferences Screen Click the down arrow in the COM Port list box to display the available communications ports and select a port from the list IMPORTANT Do not configure any other programs e g PDAs to use the same communications port you have selected to communicate with the Validator Kaye Validator User s Manual 67 Chapter 3 Installing the Software and Creating User Accounts 3 7 Selecting a Communications Port cont The selected COM port displays on the Preferences screen as shown in Figure 37 below 23 Setup Not Selected Main Hardware Preferences Help Temperature Units Line Frequency Pressure Units Celsius 60 Hertz Bar O Fahrenheit O 50 Hertz Company Name
43. 11 2 11 2 11 2 1 21 Computer Management Data Sources ODBC Event Viewer iSCSI Initiator Local Security Policy Memory Diagnostics T 11 2 1 21 1 21 11 2 Print Management Reliability and Perform Services System Configuration 1 21 Figure 103 Administrative Tools Window 3 From Computer Management click on Local User and Groups and highlight Groups Figure 104 below Ay Computer Management File Action View Help 2 15 ois 665 Computer Management Local a System Tools Task Scheduler MA Event Viewer Shared Folders Local Users and Groups Reliability and Performe dl Device Manager a 5 Storage fe Disk Management Bly Services and Applications Name E Users modified 2008 3 43 AM 2006 1 53 PM 2006 1 54 PM 2006 1 54 PM 2008 3 44 AM 11 2 2006 1 55 PM 2008 3 43 AM 2008 3 43 AM 2006 1 53 PM 11 2 2008 3 44 AM 2006 1 53 PM 2006 1 54 PM Actions Local Users and Groups More Actions Groups More Actions Figure 104 Local Users and Groups Window 158 Kaye Valid ator User s Manual Appendix A Installing Kaye Validator on the Windows Vista Operating System A 3 Adding the GE Sensing User Group cont 4 Right click on Groups gt New Group In the New Group window Figure 105 below type the Group name and click Add New Group Group name Kaye Validation Group Description Kaye Members
44. Account Creating 0 0 0 ssassn enaere 57 System Components ooo 1 System Logi Screenis i rasna ea p E A E We Rae wh Bee ae ah Rowe aati oe 98 1134 System Message Paused Floppy 0 0 0 00sec cece eee e eens 128 System Message Verification Screen 0 0 eee eens 126 System Message Screen 1 2 0 nananana 86 1123 System Specifications vic cee pri tag A Od HERE ue eee ed wae lee 149 T Temperature References ia tt Et eae 31 Temperature Sensors Calibrating 00 0 cece eee eens 71 Thermocouple Connecting dere 6 3 3 5 ps Seen he ee Ea aid Pe poe eee pea baa pene eee de heen 27 Thermocouple Types ressas snp A a os 24 Thermocouples ane Bike easy Sete A ae Les E eee Pe 150 182 Kaye Validator User s Manual U USB Disk Selecting sis ccs eine O A ies 78 USB Flash Drive Interface 0 0 0 cee eee eee eee 4 118 USB Patch fot Windows Vista ia a Sia ss wala ar Salt dn Barareh ees 163 User ACCESS doo code eee as in ie de ices Ee aoe DUO a RAS Rok wn Bees Bes 7 User Access Levels iii a ai ia elon ee nS ee ead eee ce 7 User Account Controla ita eed 153 User ACcCcoM St ii is alos 7 COMA EA AL ti 59 Disable soie A dd cis 62 Disabling after login iaa it wae ela Mee es 51 User Group in Windows Vista e iia pelea eae AR ete Gee ee ah 158 User ID Display Sond oy ens estan a Pade gay eek Moe Mende Hata eae Rees 51 User Identification UserID dick ccs a rare tine o Heese gan ee 8 User List Printi
45. COM Port Authorized User coi IRTD Stability Threshold Machine ID Qualification Reports Lower limit 1225450702 lt x Report Wizard mo 24 400 a c Akematet Merge ValProbe studies 1225450702 Data Directory W Program Files April Vistat BACKUPS Offline Figure 37 Preferences Screen with Selected Port You can also select on the Preferences tab Temperature units Celsius or Fahrenheit for all temperature calculations The line frequency 60 Hertz or 50 Hertz The absolute pressure units for saturated steam calculations If you selected Other enter the value of 1 Standard Atmosphere in the absolute pressure units you are using The Company Name The IRTD Stability Threshold Whether you will use Report Wizard to generate qualification reports and whether you can merge ValProbe studies Report Wizard is a reporting utility that enables you to create setup calibration calibration verification and qualification reports and to export qualification data to an Excel spreadsheet file With Report Wizard you can edit the groups and sensors that appear in a qualification report select cycles change the layout of columns in the report and add comments Please note that if you do not select Report Wizard you will not be able to merge ValProbe studies Select the desired options and click OK 68 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 8 Getting He
46. DAs to use the same serial communications port you have selected to communicate with the Validator Windows printer with graphical printer capability e Color monitor with a minimum of 256 colors and resolution at least 800 x 600 3 3 Installing Kaye Validator Kaye Validator offers the option of configuring the software for network capabilities The Validator data files can thus be saved to and reported on from a central network location rather than stored on each individual PC s hard drive In addition by enabling network capabilities the Validator software will utilize one central password database for managing user names and passwords You can then manage passwords for all your users in one place rather than having a different password database on each PC running the Kaye Validator software Follow these steps to install the Kaye Validator software Before installing the software you should close any applications that may be running Ifyou are installing Kaye Validator to a network drive from which you will install it to individual PCs proceed to Installation for a Network Application on the next page If you are installing Kaye Validator to an individual PC proceed to Installation for a Standalone Application on page 55 48 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 3 1 Installation for a Network Application 1 Be sure the network drive is mapped on yo
47. Devices p cas IDE ATA ATAPI controllers 4 lt Keyboards p PY Mice and other pointing devices y amp Monitors Network adapters gt Othe Dn dia Audio Controller Pp JM Es LPT P Communications Port COM1 NP ECP Printer Port LPT GE Validator 2000 COM3 EB Processors lt gt Storage controllers y is System devices p Universal Serial Bus controllers Figure 119 Updated Device Manager with GE Validator 2000 Kaye Validator User s Manual 169 Appendix A Installing Kaye Validator on the Windows Vista Operating System no content intended for this page proceed to next page 170 Kaye Validator User s Manual Appendix B Environmental Compliance Appendix B Environmental Compliance This appendix contains information on the following topics e WEEE Directive see Section B 1 on page 171 e Battery disposal see Section B 2 on page 172 B 1 Waste Electrical and Electronic Equipment WEEE Directive GE Measurement amp Control Solutions is an active participant in Europe s Waste Electrical and Electronic Equipment WEEE take back initiative directive 2002 96 EC The equipment that you bought has required the extraction and use of natural resources for its production It may contain hazardous substances that could impact health and the environment In order to avoid the dissemination of those substances in our environment and to diminish the pressure on the natural resources we e
48. E at hele eee 59 Output Relay 2 0 o ii new Haw A eea ea e aa Ep alas 19 P ParallelPrinter Connec anaa di dd dd RA Lin a a 19 Password Expiration a atta aa a oe 50 PassWord Length sii i Specs noai aani aaea aa a aa aie 50 Password Operations Screen nunana unune 119 1135 Password System Disabling n n n 0 nnna 51 Passwords Standalone ooo 64 165 PCs Connector cc E A AAA A eet 19 PC REGUITEMENTS tai ED AA LD Olt A A ee Bes 48 Permissions Granting 0 0 0 cece eee nent e nnn eens 62 POWERS ona ao nn AN ie WSR a WE o gt ae WE pc alt Ori 152 Preferences TEM A Bid Soh See HE e ies 68 Printer Update la as cada 63 Kaye Validator User s Manual 179 Index Qualification Report Rewriting to DiskK ooooooooomomorormommmm 124 Qualification Study mios a A A A a a AES 12 Preliminary Steps o A A A ea ead 95 E RR NA 13 Qualification Study Setup n nonn ete e ene n enna 10 Qualification Study Ending Automatically a dad bars HS Das 121 Maida A A da bla 121 Qualification Study Performing Standalone 00 ee eee 95 Qualification Study Running a 0 0 0 sanean aeee 93 Qualification Study Starting 0 0 ec eee nen nenes 101 Automatically ses sitno een A A dt 101 Mandala A E AN A E ENEA ETR TVA 102 Qualifying Equipment Purpose n on nannaa naene 12 R Real Time Clock Accuracy o ooooooooooorr ttn n eee e nen nes 152 Real Time Calculations Viewing
49. GE Measurement Control Solutions Validation Kaye Validator User s Manual a M4350E Rev C imagination at work September 2010 GE Measurement Control Solutions Kaye Validator Monitoring Software System User s Manual M4350E Rev C September 2010 36 www gesensing com kayeproducts 2010 General Electric Company All rights reserved Technical content subject to change without notice Contents Chapter 1 The Kaye Validator TIO UCA e adds a do e ra e 1 1 2 Validator Benefits ea Aa A A A A 2 13 About this Manual A Ge 3 1 4 The Kaye Validator Systems sosire sae se oe pace A a pode deen 4 4 1 4 1 The Validator Hardware cocep cerusa deun terenie a e teen een n ees 4 1 42 Sensor Input Modules SIMS 0 00 eect ene eens 5 1 4 3 Plug In Hardware Connections ooooooooooorrrr teen eens 6 1 5 The Validator Software sci a Speck aia 7 ksd User Access our tito setulae baw lr P O 7 125 22 User Identifica 2 id ti o dao 8 1 5 3 Electronic Data Requirements 0 0 0 cece tenes 9 1504 A MAA oy eee Lek Bae eat AR TR AT 10 1 5 5 Sensor Calibration iii ti pisos psec ate PEO ide ein dio 11 1 5 6 The Qualification Study 0 0 ccc ttt eens 12 1 5 6Report Generation il A bee ee a da 12 1 6 Using the Validator System o ooooooooorororrr teen tent n ees 13 Chapter 2 The Validator Hardware 2 1 Introduction E A RSs hg Da Se es Paresh ewe oes 15 2 2 The Validator Instru
50. Now you are ready to calibrate the sensors 82 Kaye Validator User s Manual Chapter 4 Calibrating Sensors 4 2 3 Calibrating Sensors The Validator automatically calibrates sensors at the setpoints defined in your setup Before starting calibration make sure you have a USB flash or floppy disk in the disk drive If you are printing calibration data to an attached printer make sure the printer is connected to the Validator and powered on In the following example you perform a two point calibration low setpoint and high setpoint and a one point check check setpoint To calibrate sensors 1 From the Sensor Confirmation screen shown in Figure 48 below press Run Calibration Sensor Confirmation Reselect ei Temp 01 Cancel eke Temp 03 ea Temp 04 Run Calibration Run Verification Main Menu Figure 48 Sensor Confirmation Screen The Validator clears calibration offsets stored in the SIMs for the selected sensors and establishes communications with the temperature reference and the IRTD When this is accomplished the Sensor Calibration screen Figure 4 11 on the next page displays The sensor locations and IRTD title display in reverse video until they reach stability Kaye Validator User s Manual 83 Chapter 4 Calibrating Sensors 4 2 3 Calibrating Sensors cont IMPORTANT All calibration offsets will be deleted from the SIMs if the calibration parameters or temperature units of the new setu
51. OO AAA E Ss no content intended for this page proceed to next page 70 Kaye Validator User s Manual Chapter 4 Calibrating Sensors Chapter 4 Calibrating Sensors 4 1 Introduction Before you perform a qualification study you should calibrate your temperature sensors to correct raw temperature readings to a traceable temperature measurement standard The Kaye Validator can perform standalone or PC controlled calibration e You can perform standalone calibration only if your validation system includes a Kaye temperature reference and IRTD e You can perform PC controlled calibration automatically if your validation system includes a Kaye temperature reference and IRTD or manually if your validation system does not include a Kaye temperature reference and or IRTD IMPORTANT The Validator is designed to run either as a standalone instrument or PC controlled When calibrating sensors all major actions should be consistent If the PC is connected you should control sensor calibration from your PC During sensor calibration you can use the PC and or the Validator to view data and track your progress The Validator uses the calibration parameters defined in your setup to perform sensor calibration Calibration parameters specify the temperature reference setpoints at which calibration is performed and the stability and deviation criteria for the temperature sensors and the temperature standard See Specifying Calibration Paramet
52. Q and 62 5 Q The 250 Q resistor converts a 4 20 mA signal to 1 5V The 62 5 2 resistor converts a 4 20 mA signal to 0 25 1 25V GE recommends the 250 Q resistor tt 4 Current Transmitter Figure 13 Current Transmitter Connection 2 4 Kaye IRTD The Kaye IRTD temperature measurement standard is a self contained measurement system providing temperature data directly to the Validator software The measurement accuracy is NIST traceable to 0 025 C with a range of 183 C to 420 C The IRTD provides a traceable standard that is used to correct the temperature readings of your thermocouples During the calibration process the Validator automatically reads and monitors the value of the temperature reference and the IRTD probe The IRTD probe is shipped from the factory with its baud rate set to 9600 and its address set to 01 The Validator communicates with IRTD probes with addresses 01 or 02 However if both IRTD probes are set to 01 the system displays a communications error The Validator also reports a communications error if an IRTD is disconnected from the unit during sensor calibration or a qualification study 30 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 5 Temperature Reference Temperature references provide the stable temperature required for sensor calibration GE has five temperature reference models available They are designed to provide different temperature ranges a
53. The actual screen varies with the disk type you are using Password Operations Load Setup Calibrate Sensors Start Qualification Select USB Disk Storage Rewrite Report to Floppy Main Menu Figure 94 Password Operations Kaye Validator User s Manual 145 Chapter 6 Calibration Verification 6 2 4 Rewrite Report to Disk cont Password Operations Load Setup Calibrate Sensors Start Qualification Select Floppy Disk Storage Rewrite Report to USB Disk Main Menu Figure 95 Password Operations 3 Press Rewrite Report to Disk 146 Kaye Validator User s Manual Chapter 6 Calibration Verification 6 2 4 Rewrite Report to Disk cont The Validator copies the calibration verification report file to the disk While the file is being saved the green indicator light on the drive is lit When the qualification report file is saved the System Message screen displays as shown in Figure 96 below System Message MESSAGE TIME 13 Apr 2005 Tues 10 49 51 Continue Disk Recording Complete Verification Status PASSED Figure 96 System Message Recording Complete Kaye Validator User s Manual 147 Chapter 6 Calibration Verification no content intended for this page proceed to next page 148 Kaye Validator User s Manual Chapter 7 Specifications Chapter 7 Specifications 7 1 Total System Specifications When you use specifications to compare different equipment ensure that you
54. alidator software includes a comprehensive reporting utility that allows you to access original study data to generate easy to read reports to document the specifics of your validation study All reports are generated from secure data files that can only be read by the Validator software You can create four different report types Setup Report e Calibration Report e Qualification Report e Calibration Verification Report Each report is traceable to the original study data You can export qualification data to an Excel spreadsheet file for further analysis Reports are not saved you create reports each time from the secure data files If a secure data file is tampered with it is no longer readable by the software and you will not be able to generate reports For a more complete description of report generation see the Validator online Help 12 Kaye Validator User s Manual Chapter 1 The Kaye Validator 1 6 Using the Validator System The Validator system allows you the flexibility to design your qualification procedures to fit your workplace requirements To perform a typical qualification study GE recommends the following steps in order 1 Use the Validator software to create a setup A setup defines the type of sensors and the validation parameters specific to your production process If you have pre wired SIMs assign your sensor locations according to the SIM configuration 2 Print the Setup Report Use t
55. as three thermocouple wells and two 12 inch nylon spacers to allow you to properly position your thermocouples and Kaye IRTDs LTR 25 140 LTR 40 140 and HTR 400 To insert thermocouple sensors into the LTR 25 140 LTR 40 140 and HTR 400 Insert the thermocouple sensors into the inserts and push all the way down into the well For 22 gauge wire three Type T PTFE or Kapton thermocouples fit into each well For 28 gauge wire six Type T PTFE thermocouples fit into each well To install the IRTD into the LTR 25 140 LTR 40 140 and HTR 400 Insert the IRTD very slowly into one of the two reference wells the two small wells in the LTR 25 140 LTR 40 140 or HTR 400 Do not drop it from the top of the well To prevent mechanical shock to the IRTD when immersing it in a new temperature environment ensure that the immersion process takes place over a 30 second interval The IRTD should fit snugly but still be easily removed CTR 80 To insert thermocouple sensors into the CTR 80 e Loosen the sliding clamp mechanism on a thermocouple well insert the thermocouple sensors 7 5 inches into the well slide the clamp into place and tighten the clamp to hold the sensors in place When properly installed the sensors will protrude approximately 0 5 inches beyond the end of the thermocouple wells For 22 gauge wire 12 PTFE thermocouples fit into each well Note The access cover which is 7 5 inches wide can be used as a measuring de
56. ator disk recording site option See Setting Site Options in Chapter 3 Before you begin the calibration verification process e Place the Validator in a location with stable and even temperature not exposed to any local heat sources i e close to a sterilizer an open door causing a draft etc Temperature variations and or exposure to external heat sources during calibration verification may cause temporary temperature measurement errors e To provide maximum accuracy during the calibration verification process power up the Validator and let it run for approximately 30 minutes in the operating environment where calibration verification is to be performed in order for the Validator to acclimate to the ambient temperature Place the temperature sensors and the IRTD into the temperature reference The temperature reference provides the stable temperature required for calibration verification This chapter provides instructions on performing a standalone calibration verification For instructions on performing a PC controlled calibration verification see the Validator online Help 132 Kaye Validator User s Manual Chapter 6 Calibration Verification 6 2 Performing a Standalone Calibration Verification You can perform standalone calibration verification only if your validation system includes a Kaye temperature reference and IRTD The Validator automatically sets the temperature reference to the specified verification setpoi
57. aye Validator User s Manual Chapter 2 The Validator Hardware 2 2 5 Backup Battery cont To discharge the battery 1 Turn the power switch on 2 Disconnect the AC power cord 3 Let the unit operate on battery power until the battery is completely discharged the fan will shut off when the battery is completely discharged 4 Turn the power switch off To recharge the battery 1 Connect the AC power cord 2 Turn the power switch on 3 Let the unit run for 3 hours to fully charge the battery A replacement battery pack part number W2005 is available from GE CAUTION Batteries must be disposed of in accordance with local state and federal regulations Kaye Validator User s Manual 23 Chapter 2 The Validator Hardware 2 3 Sensor Input Modules The Validator plug in Sensor Input Modules SIMs help reduce the time it takes to perform validation studies Each SIM has e 12 sensor input connections e A memory chip to store calibration offsets SIM serial number slot location and the serial number of the Validator measurement board where calibration was performed e A cold junction reference RTD to help maintain measurement accuracy through changing environmental conditions Each SIM accepts T J and K type thermocouples as well as current and voltage inputs up to 10 VDC Using 3 SIMs you can attach up to 36 inputs in any combination of thermocouples voltage or current inputs SIMs are designe
58. brate temperature sensors in standalone mode or from the PC using the Validator software If your validation system includes a Kaye temperature reference and a Kaye IRTD you can perform fully automatic pre qualification and post qualification calibrations If you do not have a Kaye temperature reference you can manually set your reference If you do not have a Kaye IRTD you can manually enter the reading of your temperature standard IMPORTANT Standalone calibration requires a Kaye temperature reference and a Kaye IRTD For instructions on standalone sensor calibration see Chapter 4 Calibrating Sensors For standalone calibration verification see Chapter 6 Calibration Verification For PC controlled calibration and calibration verification instructions see the Validator online Help Kaye Validator User s Manual 11 Chapter 1 The Kaye Validator 1 5 6 The Qualification Study During a qualification study the Validator performs calculations and compiles data for your reports You can run the qualification study in standalone mode or from the PC using the Validator software For instructions on running a standalone qualification study see Chapter 5 The Qualification Study For PC controlled qualification studies see the Validator online Help Report Generation The purpose of qualifying equipment is to document its performance either to satisfy regulatory requirements or to perform studies of your production processes The V
59. cation study see the Validator online Help 5 2 Performing a Standalone Qualification Study After you have defined your setup and copied it to flash or floppy disk you can load your setup into the Validator and perform a standalone qualification study In this section you e Load a setup into the Validator Start the qualification study e View real time and historical sensor readings calculations and events Review setup data Start and stop the exposure cycle Stop the qualification study Kaye Validator User s Manual 95 Chapter 5 The Qualification Study 5 2 1 Loading a Setup The Validator screen lists the setup currently loaded in the Validator If the Validator screen is not the current screen press Main Menu From the Main Menu press Setup Review and then press Summary The currently loaded setup displays on the Validator screen as shown in Figure 58 below Kaye Validator Setup Steam Sterilizer Date 31 Jan 05 G1 Distribution G2 Penetration G3 Pressure G4 Contact Copyright 1998 2006 GE Sensing Main Menu Figure 58 The Validator Screen If the setup loaded in the Validator is the one you are going to use to run your qualification study go to the next section Starting the Qualification Study IMPORTANT When you load a setup with a different calibration signature calibration parameters and or temperature units than the setup currently in memory any sensors already calibrat
60. d to be wired once and used repeatedly You can wire SIMs yourself or buy pre wired SIMs to further reduce preparation time Once the SIMs are wired you can calibrate multiple harnesses at the same time and store them for later use saving you valuable preparation time Since calibration of thermocouples requires compensation for errors measured in fractions of microvolts making these offsets specific to this instrument and SIM location GE recommends that you use the supplied erasable labels to record e SIM serial number e SIM slot number Serial number of the Validator where the sensors were calibrated and the date they were calibrated When you want to use these SIMs just pull them off the shelf and plug them in The calibration offsets are stored in the SIM s internal memory To prevent you from using the wrong instrument or SIM slot the system will alert you during the qualification run that the SIM is plugged into the wrong instrument or the wrong SIM slot The SIMs are made of high impact materials that will withstand 5000 insertions and are designed with a tilt and a drain hole to minimize the effects of condensation IMPORTANT SIMs are recognized by the system when you power up the Validator Make sure all SIMs are connected prior to powering up the Validator or you will have to power down insert your SIMs and power up again If a SIM is disconnected after power up that SIM s sensors will be read as Open and no data will be rec
61. ded in the audit trail and extracted to the PC program when the program establishes communication with the Validator 2 2 1c Menu Keys There are six menu keys the blue keys The functionality of each menu key is determined by the active display screen Press a menu key to perform the action indicated by the label corresponding to that key 2 2 1d Navigation Keys There are four navigation keys the arrow keys These keys correspond to up down left and right Use the up and down arrow keys to navigate within a screen when there is more data than fits on the display Use the left and right arrow keys to move from screen to screen Kaye Validator User s Manual 17 Chapter 2 The Validator Hardware 2 2 1e USB Flash Drive Interface and Floppy Disk Drive The Validator is equipped with a standard USB flash drive interface and a standard 1 44 MB 3 5 inch floppy disk drive for loading setups collecting data and upgrading firmware You can collect data over multiple flash or floppy disks during a qualification run allowing you unlimited data storage capability The flash drive or floppy disk drive is monitored at all times for faults and status The Validator is designed to write data to the USB flash drive interface or floppy disk drive To provide data security data is stored in secure data files that can only be read by the Validator software Files that have been tampered with are no longer readable by the software IMPORTANT
62. displays as shown in Figure 71 below Main Menu Real time Data Historical Data Setup Review Hardware Controls Figure 71 Main Menu 2 Press Setup Review Kaye Validator User s Manual 115 Chapter 5 The Qualification Study 5 2 4 Reviewing Setup Data cont The Setup Review screen displays as shown in Figure 72 below Setup Review Sensor Definitions Calculations and Events Calibration Information Summary QUAL 1 Main Menu Figure 72 Setup Review Screen 3 Press Calculations and Events 116 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 4 Reviewing Setup Data cont At this point the first of seven screens displays Press the right and left arrow keys on the Validator keypad to move to the next or previous screen Each screen is described below Event Definitions screen Displays the start and end qualification event conditions and the start and end exposure event conditions defined for the study Statistical Calculations screen Displays the statistical calculations defined for the selected group Lethality Calculations screen Displays the lethality calculation parameters and the condition during which lethality is to be calculated for the selected group Interval Calculations screen Displays the interval calculations defined for the individual sensors in the selected group Interval Summary screen Displays the interval calculations def
63. e 86 1143 Uncalibrateda ie aa a A A Salt etait ite 85 Sensors Calibrating sui da a ee 83 Sensors Select den il avec iaa aes Wial a neh area wad altwlalie ed Malate wis 138 Sensors Selecting for Calibration 0 0 00 0 cece eet eens 80 Setup Qualification Study derota ete Galas ae a Aaa Weal oid alt Rice Bee 10 Setup Data Reviewing 0 0 eee en etn enn eens 115 Setup Lists Screens 2 2 cannes ass aa ears os or Bale actin eae PAR tri 137 Setup Review Scrolls 91 1116 Setups Loading a om wei ad E Ana dica 73 196 197 1133 Shunt Resistors is a AA eed AA PY Se 30 SIMIO a A Goa ears ae hs derbi cede tik gre eel awe share et 25 Site Options Setting s s eevee eine ees nas Wee ca Basal a vata eel 50 SL aie wast ies Anish el bed ated ton a ESA aoe eles bo SR ia 152 Software Installation oo o o co 49 150 155 Software Uninstallidg ooooooorororrrrrrr ee een e eens 69 Stability Calculating si seua rii cece een ene 84 1142 Statistical Calculations Real Time Screen 0 0 00 ccc ees 108 Statistical Calculations screen 0 cc cee eee e eens 117 Kaye Validator User s Manual 181 Index Status Messages rito td ds triada 69 Steam Statistics Screen 2 occ eee teen eee eee a 117 SUPEFVISOF ee sh ene spe bee dee RN A bolt ale hae aes 7 Supervisor Account Creatin een Rei nn ai ist 59 System Administrator 0 ee eee net tenn eens 7 System Administrator
64. e Geet Gs ah Coke ahah Wie hates ie he eee AS 150 FA Thermocouples tl oe Ae Red Th ewe ee eh ee See Sees eRe one Soe be ot 150 TS Voltage Temp Coefficiente resci euie ei 150 TO Scanning Speed arrera e A ee ea eee ieee 150 ET Input Impedance ide 150 7 8 Compensator Temperature Coefficient 0 ccc eee ens 150 7 9 Common Mode Rejection serrie 0 0 ccc ect Arain Ore S 150 7 10Input Terminal Temperature Non Uniformity 0 0 0 eee eee 151 PAS Input Ranges ereere ara ean A NA 151 7 12Max Common Mode Voltage 00 ccc rr 151 7 13Environmental Temperature 0 0 cette tenet teens 151 Fe l4 Relative Humidity ni A A Ghee Ge 151 7 15Normal Mode Rejection r eee e cence teen teen eens 151 7 16Physical Specifications lt 0 2 0 s0ese eck aca 152 TAG ADO WE RA SS PS AES AE suet ee ea Bet 152 FAG2 ARA 152 7 16 3 Voltage Input Resolution 0 0 tenet eens 152 7 164 Size AA E A 30 Oe ad gat a A tas tees 152 TAC Voltage aprte E E R E 152 TOO Woeii sitet nr a E a E whe N NE EAE A 152 PANG ef A CCULACY AA E oleate eta dat Ale et 152 7 16 8 Real Time Clock Accuracy 00 00 cc cette teens 152 Appendix A Installing Kaye Validator on the Windows Vista Operating System Axl Turning Off the AC rosita ea Mire neiaa hates ti eee 153 AZ Turning On the VACA ida 156 A 3 Adding the GE Sensing User Group 0 0 0 ccc cece tenet eens 157 A 4 Installing the USB Patch for VISTA Systems 20
65. e the IRTD was calibrated and the temperature scale User defined information entered through the IRTD probe software displays in the User Label field Kaye Validator User s Manual 41 Chapter 2 The Validator Hardware 2 9 Viewing Calibration Information cont 7 Press IRTD Temp Ref Menu The IRTD Temp Ref screen Figure 23 below displays IRTD Temp Ref Time Tues 09 00 06 Real time Reading IRTD 1 IRTD 1 90 30C IRTD 2 OFFLINE IRTD 2 Temp Ref 90 30C Temp Ref Cal Menu Figure 23 IRTD Temp Ref Screen 8 Press Temp Ref The screen shown in Figure 24 below displays Temperature Reference Parameters Temp Ref 1 Address 1 Version 3 51 Model HTR 400 Cutot Temp 208 Setpoint 90 00 IRTD Temp Ref Menu Figure 24 Temperature Reference Parameters Screen 42 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 9 Viewing Calibration Information cont The Temperature Reference Parameters screen identifies the address of the temperature reference the firmware version number the temperature reference model number the cutout temperature the upper temperature limit the reference can reach and the current setpoint 2 9 1 Return to the Main Menu Now that you have reviewed the calibration information you can return to the Main Menu To return to the Main Menu 1 2 3 4 Press IRTD Temp Ref Menu From the IRTD Temp Ref screen press Cal Menu From the Calibration Inf
66. ectly to the SIM as shown in Figure 11 below Dry contact inputs can be used to make a time notation in the data file to mark start exposure stop exposure start of qualification end of qualification and to mark any events that occur during the qualification study You can also wire a dry contact to your vessel s PLC to detect status output and use it to automatically mark the start and end of the exposure cycle during the qualification study to o Figure 11 Connecting Dry Contact Inputs 2 3 1c Connecting a Voltage Input Connect a voltage input up to 10 VDC to the connectors as shown in Figure 12 below Always connect the positive lead to the positive connector and the negative lead to the negative connector Voltage Transducer Figure 12 Voltage Input Connection Kaye Validator User s Manual 29 Chapter 2 The Validator Hardware 2 3 1d Connecting a Current Transmitter With a Precision Shunt Resistor A dedicated 4 20 mA SIM discussed on the next page is available that provides 12 current inputs and a connection for an external power supply However a current transmitter can also be connected to the standard SIM Connect a precision shunt resistor to the connectors to convert the current to a measurable voltage as shown in Figure 13 below Make sure the resistor you are connecting here and the value of the shunt resistor in your setup file agree GE offers two resistors 250
67. ed will be marked as uncalibrated If you reload the original setup and you have not calibrated sensors using the new setup the offsets are restored and the sensors are marked as calibrated When you load a setup with a different line frequency than the setup currently in memory you must wait for the Validator to stabilize approximately 2 3 minutes before running a qualification study or you may see invalid data displayed You can also turn the Validator off and then back on and then run your study 96 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 1 Loading a Setup cont To load a setup 1 Insert the USB flash or floppy disk that contains your setup into the appropriate Validator disk drive In addition to setup data the disk contains the user list and the machine ID of the PC that saved the file to disk 2 Press the Security Key When you press the Security Key the Validator reads the machine ID of the PC from the disk e Ifthe machine ID on the disk is the same as the machine ID in internal memory the Validator compares the date of the user list on the disk to the date of the user list in internal memory If the user list on the disk is more recent than the one in internal memory the Validator replaces the user list in internal memory with the one from the disk e Ifthe machine ID on disk does not match the machine ID in internal memory the user list on the disk replaces the user li
68. eee eee cent en eens 43 2 10Preventive Maintenance 1 0 cece nn eee e etn een eens 44 2 10 31 Euse Replacement ii a ten ak Saree tee a Soi kg See Re tds 44 2 10 2 Calibration A ees Wee We Pa de Dae eer ee ees 44 210 3 Display Cleaning ii A SS RS ER ES 44 2 11 Transporting and Shipping 0 cee eet n ene neees 45 Chapter 3 Installing the Software and Creating User Accounts 31 Wnitro duction eeir rere rhe bee bats See ee Mee ee eae Mees ok 47 3 2 PC Requirements A Walgett ete sean act 48 3 3 Installing Kaye Validator 00 tence teen neae 48 3 3 1 Installation for a Network Application 0 0 c cece cee eens 49 3 3 laSetting up Site Options 00 eee ett etnias 50 3 3 1bEstablishing Site Preferences 0 ccc cette tenes 53 3 3 1cCompleting Installation 0 00 eees 54 3 3 2 Installation for a Local Application 20 0 0 cece cee eee eens 55 3 4 Starting Kaye Validate aE ee 56 3 4 1 Creating Your System Administrator Account 000 e eee eee eee ees 51 3 5 Creating User Accounts ade 59 3 321 Printing the User Lists 22 baci is rara Speedy 63 3 6 Standalone Pass Words AA a Sect pint ee e a tat id act 64 3 7 Selecting a Communications Port 00 sanee 66 3 8 Getting A O eee te 69 3 9 Uninstalling the Software 00 rr 69 iv Kaye Validator User s Manual Contents Chapter 4 Calibrating Sensors IN A RaSh Oe Bee Sk Se Sh alee he Dh ot eae De ie wets S
69. en using the right and left arrow keys on the Validator keypad When viewing screens the following guidelines apply Calculations e Calculations are computed and events are monitored every scan and displayed on the Validator display screen e Uncalibrated sensors are allowed to participate in all calculations and events during the qualification study Open under range over range or failed sensors are not allowed to participate in calculations or events The Display Screen The group name and the current time are displayed on each screen except for the Event Messages screen The group number is displayed in reverse video on the right side of the screen To display data for a different group press the soft key next to that group number The SIM locations of calibrated sensors display in normal video The SIM locations of uncalibrated sensors display in reverse video Open sensors are marked as OPEN failed sensors are marked as FAILED e If there are more sensors defined for the selected group than fit on the screen you will see a down arrow in the lower left corner of the screen Press the down arrow key on the Validator keypad to display the remaining sensors Kaye Validator User s Manual 103 Chapter 5 The Qualification Study 5 2 Viewing Real Time Sensor Readings Calculations and Events cont The qualification run number is displayed at the bottom of the screen The run number will increment aut
70. enu Figure 43 Password Operations Screen for Selecting Floppy Disk Storage Password Operations Load Setup Calibrate Sensors Start Qualification Select USB Disk Storage Main Menu Figure 44 Password Operations Screen for Selecting USB Disk Storage Kaye Validator User s Manual 79 Chapter 4 Calibrating Sensors 4 2 2 Selecting Sensors The sensors you select for calibration will have any previous calibration offsets deleted from the SIMs when you start calibration To select sensors for calibration 1 If you have not entered the Password Operations screen press the Security Key to enter the System Login screen shown in Figure 42 on page 78 2 Key in your user ID and press ENTER and then key in your password and press ENTER 3 Press Calibrate Sensors The Sensor Selection screen displays This screen shown in Figure 45 below lists all the temperature sensors defined in your setup The SIM numbers and sensor locations of uncalibrated sensors display in reverse video Sensor Selection gt All Sensors Criterion Select Deselect Continue Main Menu Figure 45 Sensor Selection 4 Select the sensors you are going to calibrate You can select sensors individually or select all sensors in one step 80 Kaye Validator User s Manual Chapter 4 Calibrating Sensors 4 2 2 Selecting Sensors cont To select sensors individually use the up and down arrow keys on the Valida
71. enu appears as shown in Figure 31 below 2 Setup Not Selected Ioi x ATTE Kaye Validator Thermal Validation System Mis Calibrate Sensors Create Reports Run Qualification Create or edit a setup Figure 31 Validator Main Menu 58 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 5 Creating User Accounts The Validator is designed for three levels of users System Administrator Responsible for the security of the program The System Administrator creates and maintains user accounts sets site options and backs up and restores user information Supervisor Creates and modifies setups calibrates sensors runs qualification studies and generates reports Supervisors can also change system preferences if the System Administrator has enabled the Allow Supervisors to change Preferences site option Operator Uses prepared setups to calibrate sensors run qualification studies and generate reports Operators cannot change setups or system preferences In the previous section you created a System Administrator account In this section you create Supervisor and Operator accounts IMPORTANT A good practice is to establish more than one individual as a System Administrator This way the Password Maintenance utility functions can still be accessed even if one of the System Administrators is unavailable When you create user accounts each user s name is added
72. ep is to select the sensors to be verified Kaye Validator User s Manual 137 Chapter 6 Calibration Verification 6 2 2 Selecting Sensors During sensor calibration the sensors you select for calibration have any previous calibration offsets deleted from the SIMs when you start calibration During calibration verification offsets are not deleted To select sensors for calibration verification 1 Press the Security Key The System Login screen displays as shown in Figure 85 on page 135 2 Key in your user ID and press ENTER Then key in your password and press ENTER The Password Operations screen displays as shown in Figure 86 on page 136 3 Press Calibrate Sensors The Sensor Selection screen shown in Figure 88 below displays This screen lists all the temperature sensors defined in your setup The SIM numbers and sensor locations of uncalibrated sensors display in reverse video In the following example sensors 1 01 through 1 04 have been calibrated Sensors 1 05 through 1 08 are uncalibrated Sensor Selection gt All Sensors Criteria 1 01 Temp 01 1 02 Temp 02 Select 1 03 Temp 03 1 04 Temp 04 Deselect Temp 05 Temp 06 Continue Temp 07 Temp 08 Main Menu Figure 88 Sensor Selection Screen 138 Kaye Validator User s Manual Chapter 6 Calibration Verification 6 2 2 Selecting Sensors cont 4 Select the sensors you are going to verify You can select sensors individually or select all sensors
73. eplaces the user list in internal memory with the one from the disk e Ifthe machine ID on disk does not match the machine ID in internal memory the user list on the disk replaces the user list in internal memory 74 Kaye Validator User s Manual Chapter 4 Calibrating Sensors 4 2 Loading a Setup cont When the Validator finishes comparing the machine IDs and user lists the System Login screen shown in Figure 39 below displays System Login User ID gt Password Figure 39 System Login Screen 3 Key in your user ID and press ENTER 4 Key in your password and press ENTER Kaye Validator User s Manual 75 Chapter 4 Calibrating Sensors 4 2 Loading a Setup cont The Password Operations screen displays as shown in Figure 40 below Password Operations Load Setup Calibrate Sensors Start Qualification Select Floppy Disk Storage Main Menu Figure 40 Password Operations Screen 5 Press Load Setup The Validator displays the setup files that reside on the disk and for each setup displays the setup name the name of the Supervisor who last saved the setup and the date and time the setup was saved on the Setup List screen shown in Figure 41 on the next page The setup names appear in reverse video 76 Kaye Validator User s Manual Chapter 4 Calibrating Sensors 4 2 Loading a Setup cont Setup List Steam Sterilizer John Doe 03 Apr 2005 Mon 10 34 55 John Doe 31 Apr
74. erature reference a PC a USB cable a parallel printer for printing raw data during sensor calibration and the qualification study and a contact output for signaling a PLC or other device The Validator includes a built in USB flash drive interface and a floppy disk drive for loading setups collecting data during the study and upgrading firmware a 12 line VGA display for viewing data during a study over 2 MB of internal memory to protect data during a study and a backup battery that protects data for approximately 30 minutes in case the system loses power 4 Kaye Validator User s Manual Chapter 1 The Kaye Validator 1 4 2 Sensor Input Modules SIMs The Validator uses Sensor Input Modules SIMs shown in Figure 2 below to provide secure connection of sensors to the Validator while protecting the electronics from draft dust humidity electrical noise and mechanical shock SIMs are designed to be wired once and used repeatedly You can wire SIMs yourself or buy pre wired SIMs to reduce preparation time Once the SIMs are wired you can calibrate multiple harnesses at the same time and store them for later use Figure 2 Sensor Input Module The Validator can be configured for up to 3 SIMs Each SIM has 12 sensor input connections A memory chip to store calibration offsets SIM serial number slot location and the serial number of the Validator measurement board where calibration was performed A cold junctio
75. ers in the Validator online Help The Validator allows you to calibrate sensors at a low setpoint a high setpoint or both When you start calibration the Validator computes the stability of the temperature sensors and the temperature standard at the specified setpoint according to the parameters defined in your setup When the temperature standard and all sensors pass the stability criteria the Validator logs the stability readings to the calibration report file The Validator then computes and logs deviation on the uncalibrated sensors and calibrates all sensors that passed the deviation criteria Finally the Validator computes and logs deviation on the calibrated sensors for a specified time period If you are performing a two point calibration low and high setpoints the Validator repeats this process Kaye Validator User s Manual 71 Chapter 4 Calibrating Sensors 4 1 Introduction cont You can also specify a check setpoint in your setup During check setpoint the Validator calculates and logs deviation on the calibrated sensors Calibration offsets are not altered unless a sensor fails at the check setpoint During the calibration process the Validator writes calibration data to the USB flash or floppy disk drive the PC hard drive if calibration is PC controlled and to the Validator printer if attached Note Data will not be written to the disk drive for PC controlled calibrations if the System Administrator ha
76. evices Um Multimedia Audio Controller hed rae Ti Update Driver Software p Process Disable amp Storage Uninstall pe System i Univers Scan for hardware changes Properties Ii Launches the Update Driver Software Wizard for the selected device Figure 114 Device Manager with Unknown Device 6 In the Update Driver Software window choose the Browse my computer for driver software option Figure 115 on the next page 166 Kaye Validator User s Manual Appendix A Installing Kaye Validator on the Windows Vista Operating System A 4 Installing the USB Patch for VISTA Systems cont Update Driver Software Unknown Device How do you want to search for driver software Search automatically for updated driver software Windows will search your computer and the Internet for the latest driver software for your device gt Locate and install driver software manually Figure 115 Update Driver Software Screen 7 Ifthe location in the window shown in Figure 116 below points to where you installed the patch defaulting to the Kaye Kaye Validator folder click on Next Otherwise browse to the installed folder and then click Next Update Driver Software Unknown Device Browse for driver software on your computer Search for driver software in this location C PROGRAM FILES KAYE KAYE VALIDATOR Y Include subfolders gt Let me pick from a list of device drivers on my computer This li
77. fication 6 2 3 Verifying Sensor Calibration cont Note Ifyou stop calibration verification the calibration verification report file is deleted 6 2 3a Calculating Stability The first step in the calibration verification process is to verify that the sensors and IRTD are stable Stability is the maximum allowable change in temperature for each sensor and the temperature standard over a specified time interval The maximum allowable change in temperature for the IRTD is fixed at 0 012 C 0 022 F for one minute if all temperature setpoints are equal to or greater than 0 0 C 32 0 F If any temperature setpoint is less than 0 0 C 32 0 F you can enter the IRTD stability value manually in your setup The stability calculation begins once the temperature reference is within 5 degrees of the low setpoint Stability is computed at the scan rate Calibration Verification Automatic Stabilizing Low Setpoint 89 961C 90 00C Elapsed Time 0000 00 00 TEMP STABILITY 89 94C 89 99C 89 93C 89 92C Criteria Figure 92 Calibration Verification Screen To achieve stability the IRTD and all sensors must meet the stability criteria defined in the setup The IRTD and sensors display in normal video when they reach stability If any sensors fail to reach stability the calibration verification process remains here To end the calibration verification process press STOP 142 Kaye Validator User s Manual Chapter 6 Calibration Ve
78. for the Validator to stabilize approximately 2 3 minutes before verifying sensor calibration or you may see invalid sensor data displayed You can also turn the Validator off and then back on and then verify calibration To load a setup 1 Insert the disk that contains your setup into the Validator disk drive In addition to setup data the disk contains the user list and the machine ID of the PC that saved the file to disk 2 Press the Security Key When you press the Security Key the Validator reads the machine ID of the PC from the disk e Ifthe machine ID on disk is the same as the machine ID in internal memory the Validator compares the date of the user list on the disk to the date of the user list in internal memory If the user list on the disk is more recent than the one in internal memory the Validator replaces the user list in internal memory with the one from the disk e Ifthe machine ID on disk does not match the machine ID in internal memory the user list on the disk replaces the user list in internal memory When the Validator finishes comparing the machine IDs and user lists the System Login screen displays as shown in Figure 85 on the next page 134 Kaye Validator User s Manual Chapter 6 Calibration Verification 6 2 1 Loading a Setup cont System Login User ID gt Password Figure 85 System Login Screen 3 Key in your user ID and press ENTER 4 Key in your password and p
79. g a PC or notebook USB PC Connector One USB PC connector labeled with a USB icon is available for connecting a PC Parallel Printer Connector There is one 25 pin sub D connector labeled with a printer icon for connecting an Epson LX 300 printer to the Validator for printing during sensor calibration and the qualification study Use a standard Centronics printer cable to connect the printer to the Validator Kaye Validator User s Manual 19 Chapter 2 The Validator Hardware 2 2 3 Symbol Identification A Protective Earth Terminal Caution Refer to accompanying documentation 20 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 2 4 Internal Memory The Validator is designed to write data to internal memory USB flash disk floppy disk and your PC hard drive 1f connected during sensor calibration and qualification studies Qualification data resides in internal memory until you power down the system or load a new setup The Validator provides over 2 MB of internal memory to maintain qualification data during a study When running a qualification study internal memory can fill up quickly depending on the length of your study and your file rate the rate at which data is written to internal memory USB flash or floppy disk and the PC hard drive during a qualification run File rates are limited to valid rates for the number of assigned sensors and the scan rate
80. he Setup Report to verify your validation parameters and as a reference for connecting your sensors 3 Ifyou do not have pre wired sensors wire your thermocouples and auxiliary sensors to the SIMs as based on the Setup Report 4 Connect the hardware and confirm connections Once the hardware is connected use the Validator software to display a graphical representation of your validation equipment to verify hardware and communications connections 5 Load the setup into the Validator to calibrate sensors and run your study standalone or you can calibrate sensors and run your study directly from your PC IMPORTANT The Validator is designed to run either as a standalone instrument or PC controlled When calibrating sensors and running qualification studies all major actions should be consistent If the PC is connected you should control sensor calibration and your qualification study from your PC During sensor calibration and the qualification study you can use the PC and or the Validator to view data and track your progress 6 With your hardware configured for the validation study e Calibrate sensors against the temperature standard Run the qualification study Run post qualification calibration verification Kaye Validator User s Manual 13 Chapter 1 The Kaye Validator 1 6 Using the Validator System cont The Validator collects all study data and stores it in a secure data file internally on USB flash or floppy
81. hown in Figure 76 below Password Operations Stop Exposure Stop Qualification QUAL 1 Main Menu Figure 76 Password Operations Stop Qualification Screen 4 Press Stop Qualification 122 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 66 Ending the Qualification Study Manually cont The Sensor Inputs Real Time screen displays briefly followed by the System Message screen shown in Figure 77 below System Message MESSAGE TIME 05 Mar 2005 Wed 15 07 19 MESSAGE LEVEL Warning Continue MESSAGE DESCRIPTION Floppy Disk Recording Complete Figure 77 System Message Screen IMPORTANT Do not remove the disk until you acknowledge that the disk write is complete by pressing Continue If you remove the disk before the disk drive light goes out you may lose data 5 Press Continue and then remove the disk from the drive The disk contains the qualification report file Now that your qualification study is complete you can take the disk to your PC to generate a Qualification Report See the Validator online Help for information on generating a Qualification Report Kaye Validator User s Manual 123 Chapter 5 The Qualification Study 5 2 7 Rewrite Report to Disk You can write an additional copy of the qualification report file to a USB flash or floppy disk using the Rewrite Report to Disk option To rewrite the qualification report file to a disk 1 Insert a USB flash or floppy
82. howto check for solutions View problem history Performance Information and Tools Check your computer s Windows Experience Index base score Use tools to improve performance Device Manager View hardware and devices Update device drivers Windows Anytime Upgrade Administrative Tools Free up disk space Defragment your hard drive Create and format hard disk partitions View event logs Schedule tasks Figure 102 The System and Maintenance Window Go to Administrative Tools gt Computer Management Figure 103 on the next page and acknowledge the Microsoft warning by clicking on Continue 49 Search Appendix A Installing Kaye Validator on the Windows Vista Operating System A 3 Adding the GE Sensing User Group cont OQ E System and Maintenance Administrative Tools E Documents E Pictures B Music More gt Folders E Appearance and Personalization Clock Language and Region Ease of Access Hardware and Sound ME Mobile PC Network and Internet E Programs Security a 2 System and Maintenance 4 Administrative Tools Backup and Restore Center MB Performance Information and Tools 3 Power Options El System E Welcome Center Name ES Er E fa da E tan ak E E Task Scheduler EP Windows Firewall with Computer Management Date modified 1 21 2008 3 43 AM Shortcut ze 1 65 KB 4 11 2 2006 1 54 PM Ea Ez Date 1 21
83. ient 0 1 microvolts 0 001 reading C 7 6 Scanning Speed 8 or 12 inputs sec at 50 60 Hz 7 7 Input Impedance 10 MQ Source load impedance greater than 10KQ produces open circuit indication 7 8 Compensator Temperature Coefficient 0 01 C per C 7 9 Common Mode Rejection 160 dB 8 inputs sec 60 Hz 154 dB 8 inputs sec 50 Hz 145 dB 12 inputs sec 60 Hz 140 dB 12 inputs sec 50 Hz 150 Kaye Validator User s Manual Chapter 7 Specifications 7 9 Common Mode Rejection cont Note Common Mode Rejection Ratio is with a resistive imbalance of 120W This corresponds to 60 feet of 28 AWG type T thermocouple wire 150 feet of 24 AWG type T thermocouple wire 7 10Input Terminal Temperature Non Uniformity 0 1 C 7 11input Ranges 6 to 30mV 12 to 60mV 60 to 300mV 2 to 10V 7 12Max Common Mode Voltage 100V pk ch to ch 350V pk ch to frame ground 7 13Environmental Temperature 0 to 50 C 32 to 122 F 7 14Relative Humidity 95 non condensing 7 15Normal Mode Rejection 82 dB 8 inputs sec 60 Hz 76 dB 8 inputs sec 50 Hz 69 dB 12 inputs sec 60 Hz 64 dB 12 inputs sec 50 Hz Kaye Validator User s Manual 151 Chapter 7 Specifications 7 16Physical Specifications 7 16 1 Power 100 to 240 VAC 50 60 Hz 0 75A RMS Max 7 16 2 Fuse Rating 250V T2A 7 16 3 Voltage Input Resolution 0 to 10 VDC 1 72 000 7 16 4 Size H x W x D 191 mm x 343 mmW x 343 mm 404 m
84. ined for the entire group and the start and end interval conditions Steam Statistics screen Displays the value of one standard atmosphere in the units of pressure selected in your setup the location of the pressure sensor for the saturation temperature of steam calculation and the location of the temperature sensor for the saturation pressure of steam calculation e Group Event screen Displays the real time event defined for the selected group Kaye Validator User s Manual 117 Chapter 5 The Qualification Study 5 2 5 Starting and Stopping the Exposure Cycle If your qualification study includes an exposure cycle the exposure cycle can be programmed to start and or stop automatically or manually depending on the start and stop exposure conditions defined in your setup See Specifying Start Stop Conditions in the Validator online Help for more information 5 2 5a Starting and Stopping the Exposure Cycle Automatically If the start exposure and stop exposure events are triggered by a condition no action on your part is required The Validator automatically starts and stops the exposure cycle according to the start and stop exposure conditions defined in your setup 5 2 50 Starting and Stopping the Exposure Cycle Manually If one or both conditions are defined as manual you will have to start and or stop the exposure cycle manually To start exposure manually 1 Press the Security Key The System Login screen shown i
85. inputs Valid inputs are Thermocouples J K T and premium T see Connecting a Thermocouple later in this chapter Contacts see Connecting a Contact later in this chapter Voltage see Connecting a Voltage Input later in this chapter Current see Connecting a Current Transmitter With a Precision Shunt Resistor later in this chapter 4 Tighten the retaining screws Repeat Steps 2 through 4 for remaining sensors Once all sensors are connected route the wire harness around the connectors and out the drain hole Secure the harness with the tie wraps provided Follow Figure 7 below to maintain the thermal accuracy of the module 7 PA xN ocobosnouvovoa SRA p Sevseoevucsce X ee x me LM IGTRACIOS BA ATT ee NY anin cm a aT Figure 7 SIM Wiring Legend 1 Tie wraps provided by GE 2 Tie wraps optional user supplied 3 Drain hole 7 Tighten the two screws in the top of the module to close the SIM 8 Label the SIM with SIM slot number SIM serial number the Validator serial number and the calibration date Note To wire the dedicated 4 20 mA SIM see document Z2036 4 to 20 mA Sensor Input Module 26 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 3 1a Connecting a Thermocouple Connect types J K and T thermocouples to the connectors as shown in Figure 8 below Cut through the outer insulation to separate the red and blue wires and then strip back each wire app
86. ion Study 5 2 8 Pausing Data Recording During the Qualification Study During the qualification study you can pause data recording to the disk drive in order to insert a new disk into the drive before the current disk fills up and you can pause data recording to the printer attached to the Validator in order to add paper or correct a printer problem When you pause data recording to the disk drive or to the attached printer qualification data is still being written to the internal memory When you resume data recording the Validator writes the data stored in internal memory to the disk or printer and data recording to that device continues To pause data recording during the qualification study 1 From any screen on the Validator press Main Menu The Main Menu screen displays as shown in Figure 71 on page 115 2 Press Hardware Controls The Hardware Controls screen displays as shown in Figure 81 below Hardware Controls Increase Contrast Decrease Contrast Pause Disk Pause Printer Engineering Log Main Menu Figure 81 Hardware Controls Screen 3 Pause data recording to the disk drive or to the attached printer To pause data recording to the disk drive press Pause Disk To pause data recording to the attached printer press Pause Printer Kaye Validator User s Manual 127 Chapter 5 The Qualification Study 5 2 8 Pausing Data Recording During the Qualification Study cont The System Message sc
87. isk drive a USB flash drive interface a backup battery and a soft carrying case This chapter describes the Validator hardware and provides instructions for connecting the system Included are sections describing e The front of the Validator instrument which has a display screen controls for standalone operation and a floppy disk drive e The back of the Validator instrument which has a USB flash drive interface and connection ports for all system devices e Internal memory e Backup battery e Sensor Input Modules SIMs which are used to connect sensors to the Validator The Kaye temperature reference which provides the stable temperature required for sensor calibration e The Kaye IRTD a self contained temperature standard e Connecting the system Setting the Validator time and date e Setting the display screen contrast e Viewing calibration information e Preventive maintenance e Transporting and shipping Kaye Validator User s Manual 15 Chapter 2 The Validator Hardware 2 2 The Validator Instrument The Validator instrument is equipped with a display screen control keys for standalone operation a USB flash drive interface and a floppy disk drive connection ports for all system devices over 2 MB of internal memory and a backup battery in case the system loses AC power 2 2 1 Display Screen and Control Keys The front of the Validator shown in Figure 4 below has a display screen control keys security
88. libration information 1 From the Main Menu press Setup Review The Setup Review screen shown in Figure 17 below displays Setup Review Sensor Definitions Calculations and Events Calibration Information Summary Main Menu Figure 17 Setup Review Screen Kaye Validator User s Manual 37 Chapter 2 The Validator Hardware 2 9 Viewing Calibration Information cont 2 Press Calibration Information The Calibration Information screen shown in Figure 18 below displays Calibration Information System Calibration Sensor Calibration IRTD Temp Ref Review Menu Figure 18 Calibration Information Screen 3 Press System Calibration The screen in Figure 19 on the next page displays 38 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 9 Viewing Calibration Information cont System Calibration S N 00010007 MB S N 0499029 Calibrated 07 Oct 2002 FW Version 3 10 Setup Default Setup Sensor Input Modules S N Calibrated 1 12345678 01 Jan 05 2 98765432 02 Jan 05 3 34567876 03 Jan 05 Figure 19 System Calibration Screen The System Calibration screen identifies the Validator serial number the measurement board serial number the date this unit was calibrated the installed firmware version the name of the setup that currently resides in the Validator and the serial numbers and calibration dates of the attached SIMs 4 Press Cal Menu The Calibration Informati
89. low appears Identification Required User ID Current Password Say Figure 29 Identification Required Box 3 Enter Kaye in the User ID text box Kaye is the default System Administrator user ID The User ID text box is case sensitive so make sure you enter the default user ID exactly as it appears here 4 Enter 411 in the Current Password text box 411 is the default System Administrator password 5 Click OK The Password Maintenance user screen appears shown in Figure 30 on the next page You can now create your own System Administrator account 56 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 4 1 Creating Your System Administrator Account Password Maintenance Name User ID Password Confirm password I Setup creation Y Audi Trad view and peint I Qualification execution IV Preference Modification I Sensor calibration execution 7 Instrument Calbeation TF Verity sensor calibration IV Modily site options IV Create reports IV Password Maintenance TF Move ce delete studies E EA oe Ce Joe Figure 30 Password Maintenance User Screen Once your System Administrator account is created the default account you used to log on to the system Kaye 411 will be deleted You will then be logged in under the user name you create Note At this point the only options available are those for a System Administrator therefore
90. lp There are four ways to get help while using the Validator software Help Screen Click the Help tab to access the Help screen From the Help screen you can access the online help Contents and Index Help Button Click the help button on any screen to display online help for the currently active screen F1 Function Key Position the cursor on the field or control that you want help on or tab to that field or control and press the F1 function key to display context sensitive help for that field or control If that field or control does not have its own help topic the help topic for the active screen displays Status Messages When you move your cursor over a control or item on the screen a brief status message appears at the bottom of the screen 3 9 Uninstalling the Software If for any reason you need to uninstall the Validator software access the Validator uninstall program through Windows To uninstall the software Click Start gt Settings gt Control Panel Double click Add Remove Programs 1 2 3 Select Kaye Validator from the list of programs and click Change Remove 4 Follow the on screen instructions to uninstall the software 5 Select Kaye Validator Initialization from the list of programs and click Change Remove 6 Follow the on screen instructions to uninstall the software Kaye Validator User s Manual 69 Chapter 3 Installing the Software and Creating User Accounts gq OO __RO_QR_E
91. m and the Validator instrument Audit trail files contain all events and identify the type of action performed the date and time the action occurred the name of the responsible operator and any additional information required to understand the action taken The Validator software detects when files have been added or removed outside of the program When a discrepancy is detected the software informs the user at startup and asks them to take responsibility for the added or missing file s If responsibility is denied the software will continue to inform the user of the discrepancy when the software is launched If responsibility is accepted the software will request a user ID and password Acceptance and denial of responsibility is logged in the audit trail Kaye Validator User s Manual 9 Chapter 1 The Kaye Validator 1 5 4 The Study Setup The study setup defines everything required to calibrate sensors and run a qualification study When you create a setup you Define the sensors you are going to use in the study e Assign sensors to groups and specify group calculations Define group events to be monitored during the qualification study Enter group comments to be used in report headers e Specify calibration setpoints temperature stability and deviation criteria for sensor calibration Specify start and stop conditions for the qualification cycle and the exposure cycle e Specify how often to scan sensors S
92. m with SIM 7 5 in x 13 5 in x 13 5 in 15 9 in with SIM 7 16 5 Voltage Input 30 days 0 003 of reading 2 counts 4 microvolts 7 16 6 Weight 9 kg 20 Ib 7 16 7 Accuracy 1 year 0 006 of reading 2 counts 4 microvolts 7 16 8 Real Time Clock Accuracy 15 seconds per 24 hours 0 0174 from 20 to 30 C 152 Kaye Validator User s Manual Appendix A Installing Kaye Validator on the Windows Vista Operating System Appendix A Installing Kaye Validator on the Windows Vista Operating System In order to run the Kaye Validator Setup exe successfully on a Windows Vista operating system you must turn off the User Account Control UAC Once the Validator software is installed you must then turn UAC back on You will also need to add the GE Sensing user group and to install a USB patch for Windows Vista IMPORTANT To ensure a smooth installation be sure to complete all four steps A 1 Turning Off the UAC 1 From the Start menu go to Control Panel Figure 97 below Help and Support SF tun Shut Down 7 y Figure 97 Windows Vista Control Panel 2 In the Control Panel Search box type in the letters uac Figure 98 on the next page Kaye Validator User s Manual 153 Appendix A Installing Kaye Validator on the Windows Vista Operating System A 1 Turning Off the UAC cont Jeg aS gt Control Panel Control Panel Home in da User Accounts Get sta
93. ment 0 2 0 0 ccc tte nnn teens 16 2 2 1 Display Screen and Control Keys 00 16 22 laDisplay Screens x ctc os Sisk wots Ay ike ae naan hen eel one 16 2 2 1 bSecurity Key roic etai gk ds 17 2 21 CME K Si A RARA ER 17 2 2 1dNavigation Keys 0 id tddi da dd 17 2 2 1eUSB Flash Drive Interface and Floppy Disk Drive o o oooooooo 18 2122 Connection Ports ni tas or bes 18 2 2 3 Symbol Identification voi o a eo eR oe E ee eae ee 20 22 4 Internal Memo a FR 21 22 9 Backup Bai a Skeet alee 22 2 3 Sensor Input Modules oooooooooorr cect E E etn en ees 24 23 40 Wiring SIMS ri cere ae Beh tee as bh eae ey ia 25 2 3 laConnecting a Thermocouple 0 00 ro 27 Kaye Validator User s Manual iii Contents 2 3 1bConmnecting a Contact eis eee eae teen tent EE 29 2 3 1cConnecting a Voltage Input o oooooooocoorrrorr eens 29 2 3 1dConnecting a Current Transmitter With a Precision Shunt Resistor 30 24 Kay RT Dd oa 30 2 5 Temperature Reference ooooooooorrrrr ect ent e nen en ens 31 2 5 1 Sensor and IRTD Installation 2 0 0 0c eee eens 32 2 0 Connecting the SYst wo ss SE three pea ag eee E ed Soe 33 2 7 Setting the Validator Time and Date 20 eee cet eee ens 34 2 8 Setting the Display Screen Contrast s s 00 cece teen eens 34 2 9 Viewing Calibration Information 0 cece ccc een tent e eens 37 2 9 1 Return to the Main Menu 0 ee
94. n Figure 73 below displays System Login User ID gt Password Figure 73 System Login Screen 118 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 5b Starting and Stopping the Exposure Cycle Manually cont 2 Key in your user ID and press ENTER 3 Key in your password and press ENTER The Password Operations screen displays as shown in Figure 74 below Password Operations Start Exposure Stop Qualification QUAL 1 Main Menu Figure 74 Password Operations Screen 4 Press Start Exposure The Sensor Inputs Real Time screen displays Kaye Validator User s Manual 119 Chapter 5 The Qualification Study 5 2 5b Starting and Stopping the Exposure Cycle Manually cont To stop exposure manually 1 Press the Security Key The System Login screen displays as shown in Figure 73 on page 118 2 Key in your user ID and press ENTER 3 Key in your password and press ENTER The Password Operations screen displays as shown in Figure 75 below Password Operations Stop Exposure Stop Qualification Main Menu Figure 75 Password Operations Stop Exposure Screen 4 Press Stop Exposure The Sensor Inputs Real Time screen displays 120 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 6 Ending the Qualification Study You can end your qualification study automatically or manually depending on the stop qualification conditio
95. n defined in your setup See Specifying Start Stop Conditions in the Validator online Help for more information 5 2 6a Ending the Qualification Study Automatically If you have specified an automatic stop qualification condition in your setup no action on your part is required The Validator automatically ends the qualification study when the stop qualification condition is met For example you could specify a stop qualification condition in your setup that will automatically end the study when accumulated lethality is greater than a fixed number When the study has ended the System Message screen displays Press Continue and remove the disk from the drive The disk contains the qualification report file Now that your qualification study is complete you can take the disk to your PC to generate a Qualification Report See the Validator online Help for information on generating a Qualification Report Kaye Validator User s Manual 121 Chapter 5 The Qualification Study 5 2 66 Ending the Qualification Study Manually If you have specified Manual as the stop qualification condition in your setup you have to login to the Validator and manually end the qualification study To end the qualification study manually 1 Press the Security Key The System Login screen displays as shown in Figure 73 on page 118 2 Key in your user ID and press ENTER 3 Key in your password and press ENTER The Password Operations screen displays as s
96. n reference RTD to maintain measurement accuracy in different environmental conditions Using 3 SIMs you can attach up to 36 inputs in any combination of thermocouples voltage or current inputs A dedicated 4 20 mA SIM is also available with 12 4 20 mA inputs and one connection for an external power supply Kaye Validator User s Manual 5 Chapter 1 The Kaye Validator 1 4 3 Plug In Hardware Connections The Validator has connectors on the back of the unit for easy plug in of SIMs temperature standards temperature references a printer a USB cable USB memory card and a PC An icon indicating the type of device identifies each connector Figure 3 Validator Connections For a more complete description of the hardware see Chapter 2 The Validator Hardware 6 Kaye Validator User s Manual Chapter 1 The Kaye Validator 1 5 The Validator Software The Validator software provides everything you need to perform validation testing Using the Validator software you e Create user accounts and assign user IDs passwords and permission levels e Create validation study setups that can be run standalone on the Validator or from a PC When calibrating sensors and running qualification studies from the PC the Validator software features expanded tools for graphing study data Generate reports from secure data files that contain original calibration and qualification data recorded during the study Use the reporting utility
97. ncourage you to use the appropriate take back systems Those systems will reuse or recycle most of the materials of your end life equipment in a sound way The crossed out wheeled bin symbol invites you to use those systems If you need more information on the collection reuse and recycling systems please contact your local or regional waste administration Visit www ge com inspectiontechnologies for take back instructions and more information about this initiative RF ValProbe User s Manual 171 Appendix B Environmental Compliance B 2 Battery Disposal This product contains a battery that cannot be disposed of as unsorted municipal waste in the European Union See the product documentation for specific battery information The battery is marked with this symbol which may include lettering to indicate cadmium Cd lead Pb or mercury Hg For proper recycling return the battery to your supplier or to a designated collection point B 2 1 What do the Markings Mean Batteries and accumulators must be marked either on the battery or accumulator or on its packaging depending on size with the separate collection symbol In addition the marking must include the chemical symbols of specific levels of toxic metals as follows e Cadmium Cd over 0 002 e Lead Pb over 0 004 Mercury Hg over 0 0005 172 RF ValProbe User s Manual Appendix B Environmental Compliance 8 2 2 The Risks and Your Role
98. nd are compatible with the Validator LTR 25 140 setpoint range 25 C to 140 C at 25 C ambient Recommended for calibration of sensors used in freezers cold rooms incubators and steam autoclaves The LTR 25 140 accepts up to 18 thermocouples LTR 40 140 setpoint range 40 C to 140 C at 25 C ambient Recommended for calibration of sensors used in freezers cold rooms incubators and steam autoclaves The LTR 40 140 accepts up to 18 thermocouples HTR 400 setpoint range 25 C above ambient to 400 C Recommended for calibration of sensors used in steam autoclaves dry heat ovens and tunnel sterilizers The HTR 400 accepts up to 24 thermocouples CTR 80 setpoint range 80 C to 100 C Recommended for calibration of sensors used in freeze dryers freezers and cryogenic units The CTR 80 accepts up to 36 thermocouples CTR 40 setpoint range 40 C to 150 C Recommended for calibration of sensors used in freezers cold rooms incubators and steam autoclaves The CTR 40 accepts up to 36 thermocouples Kaye Validator User s Manual 31 Chapter 2 The Validator Hardware 2 5 1 Sensor and IRTD Installation The Kaye LTR 25 140 LTR 40 140 and the HTR 400 temperature references have inserts for thermocouples and two Kaye IRTDs Failure to use these inserts to achieve proper thermocouple placement in the temperature reference will result in reduced accuracy during calibration The Kaye CTR 80 temperature reference h
99. ndalone users when their passwords are nearing the expiration date allowing them time to use the software to change their password For users who routinely access the Validator software they will receive a prompt at login when there are five days or less until their password is set to expire It is possible that a user running a study in standalone mode could login with their user ID and password to start a qualification study but be unable to stop the study because by that time their password has expired In this circumstance follow the steps below to safely stop the study without losing data 1 On the Sensor Inputs Real Time screen at the Validator instrument press the Main Menu soft key 2 On the Main Menu press Hardware Controls Press Pause Disk on the Hardware Controls screen 3 Once the USB flash or floppy drive indicator light goes out disk recording is paused Eject the flash or floppy disk from the drive Insert a new disk in your PC s flash or floppy drive and start the Validator software 64 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 6 Standalone Passwords cont 4 From the Main Menu click the Preferences tab At the Identification Required login screen enter the expired user ID and password and click OK Change the password when prompted and return to the Main Menu Use the Validator software to copy a setup it does not matter which one the pu
100. ng occ yde0y Gerd A PR ee ote eee 63 V Validation Study Setups casts Gscicn aden E ae dass aia ane en see Rasa bane 7 Validator Screen s parer ae seats ge cee gy aac Oe anne AO I ee eh aoe 133 Voltage Inputs ida a 152 Voltage Input Resolution 0 0 0 0 0 cc e eee eens 152 Voltage Input Connecting 0 0 cette nent eens 29 Voltage Temp Coetficlent s erepti eink haste Ee Nae Cake Wace o LRA ees RS eee 150 W Watios eed cai tees AS a A EAE TA 185 Waste Disposal Batteries aa E A 172 Electronic Equipment sacred eiaei tent nents 171 WEEE Directive s 24 i065 aoe A A a 171 Weights e o oy Butea it Gola Gk 152 Windows Vista ii oe E ee hare E A Bae Aia 153 Kaye Validator User s Manual 183 Index 184 Kaye Validator User s Manual Warranty Warranty Each instrument manufactured by GE Sensing is warranted to be free from defects in material and workmanship Liability under this warranty is limited to restoring the instrument to normal operation or replacing the instrument at the sole discretion of GE Sensing Fuses and batteries are specifically excluded from any liability This warranty is effective from the date of delivery to the original purchaser If GE Sensing determines that the equipment was defective the warranty period is one year for general electronic failures of the instrument one year for mechanical failures of the sensor If GE Sensing determines that the equipment was damaged by misuse
101. nt Low High Check and automatically reads the value of the IRTD at that setpoint In this section you e Load a setup into the Validator e Select sensors to verify Run calibration verification 6 2 1 Loading a Setup The Validator screen lists the setup currently loaded in the Validator If the Validator screen is not the current screen press Main Menu From the Main Menu press Setup Review and then press Summary The currently loaded setup displays on the Validator screen as shown in Figure 84 below Kaye Validator Setup Steam Sterilizer Date 31 Jan 05 G1 Distribution G2 Penetration G3 Pressure G4 Contact Copyright 1998 2006 GE Sensing Main Menu Figure 84 Validator Screen Kaye Validator User s Manual 133 Chapter 6 Calibration Verification 6 2 1 Loading a Setup cont If the setup loaded in the Validator is the one you are going to use for calibration verification go to the next section Selecting Sensors IMPORTANT When you load a setup with a different calibration signature calibration parameters and or temperature units than the setup currently in memory any sensors already calibrated will be marked as uncalibrated If you reload the original setup and you have not calibrated sensors using the new setup the offsets are restored and the sensors are marked as calibrated When you load a setup with a different line frequency than the setup currently in memory you must wait
102. odules SIMs A Kaye high temperature reference HTR 400 a Kaye low temperature reference LTR 25 140 or LTR 45 140 or a Kaye cold temperature reference CTR 80 e A Kaye Intelligent RTD probe IRTD Premium grade thermocouples e Additional temperature and non temperature sensors for qualification studies optional e An Epson LX 300 printer optional attached to the Validator for printing during sensor calibration and the qualification study Kaye Validator User s Manual 1 Chapter 1 The Kaye Validator 1 2 Validator Benefits The Kaye Validator brings important benefits to the validation process Designed to help meet FDA guidelines for protecting electronic data 21 CFR Part 11 Fully validated software hardware and firmware Measures and adjusts internal voltage continuously Flexibility to operate as standalone or with a PC during testing Built in floppy disk drive for loading setups collecting data and upgrading firmware Built in USB flash drive interface for loading setups collecting data and upgrading firmware Over 2 MB internal memory to protect data in case floppy disk or flash disk fills up Battery backup for up to 30 minutes if system loses power Plug in Sensor Input Modules minimize sensor handling and save calibration time More flexibility to set up your test assign sensors to groups to perform independent calculations perform distribution and penetration tests at the same time or qualify
103. omatically when you use the same setup to run multiple studies consecutively 5 2 1 Viewing Real Time Sensor Readings When qualification starts the Sensor Inputs Real Time screen displays as shown in Figure 62 below This screen displays the real time readings for all sensors in the selected group by SIM location and sensor label Sensor Inputs Real Time Group Distribution Time Wed 14 41 05 1 01 Temp 01 89 47 C 1 02 Temp 02 89 42 C 1 03 Temp 03 89 96 C 1 04 Temp 04 90 01 C REE Temp 05 90 04 C UN Temp 06 89 41 C WA Temp 07 89 49 C ver QUAL 1 Main Menu Figure 62 Sensor Inputs Real Time Screen 104 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 2 Viewing Real Time Calculations and Events The calculations and group events displayed on screen during the qualification study are dependent on the calculations and group events specified in your setup The calculations displayed during the study could include e Lethality calculations Saturated steam calculations e Statistical calculations Interval summary calculations e Interval minimum calculations e Interval maximum calculations e Interval average calculations Note Ifa calculation has not been defined for the selected group the message CALCS NOT DEFINED FOR GROUP where is the group number displays on the associated calculation screen To view real time calculations and events 1 From the Sensor Inp
104. on screen Figure 20 below displays Kaye Validator User s Manual 39 Chapter 2 The Validator Hardware 2 9 Viewing Calibration Information cont Calibration Information System Calibration Sensor Calibration IRTD Temp Ref Review Menu Figure 20 Calibration Information Screen 5 Press IRTD Temp Ref The IRTD Temp Ref screen Figure 21 below displays IRTD Temp Ref Time Mon 11 06 08 Real time Reading IRTD 1 IRTD 1 90 0C IRTD 2 OFFLINE IRTD 2 Temp Ref 90 3C Temp Ref Cal Menu Figure 21 IRTD Temp Ref Screen 40 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 9 Viewing Calibration Information cont The IRTD Temp Ref screen displays the current time and the real time temperature readings for up to two IRTDs and your temperature reference You can display more information about your IRTDs and your temperature reference from this screen 6 Press IRTD 1 or 2 to display more information about your IRTD The IRTD Parameters screen Figure 22 below displays IRTD Parameters IRTD 1 Address 1 Probe ID X2001V4 B Label KL25 60 70125 Calibrated 19 Oct 2006 User Label Displays User Label Temp Scale IPTS 68 IRTD Temp Ref Menu Figure 22 IRTD Parameters Screen The IRTD Parameters screen identifies the IRTD number 1 or 2 and the IRTD address 1 or 2 the probe ID and firmware version Probe ID the model number and serial number Label the dat
105. ons Execute or verify sensor calibration Create reports Move or delete studies View and print the Audit Trail Modify preferences Calibrate the Validator Modify site options Maintain passwords 10 Click OK The Password Maintenance screen now appears similar to Figure 34 on the next page with the new account listed Note 62 Use the scroll bar at the bottom of the screen to view additional information for user accounts Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 5 Creating User Accounts cont Disabled D Figure 34 Updated Password Maintenance Screen 11 Repeat steps 1 10 to add more users to the system 3 5 1 Printing the User List When displayed on your PC monitor the user list displays the active user accounts The printed user list contains active and deleted user accounts disabled user accounts user accounts waiting for initial login the name of the System Administrator that printed the list the date and time the list was printed the timestamp of the user list and the machine ID Note You can view deleted user accounts on your PC monitor by deselecting the Hide deleted entries option from the File menu To print the user list e From the Password Maintenance screen select File gt Print Users The user list prints to your default printer It includes a date and time stamp machine ID the user table permissions disabled and dele
106. ooocoooc cece eee nent ne eae 6 Hardware Controls Screen ee cinch ose ge eS atte RA ah AINE ae NS 127 Help Buttons eaa A A eR AD ee Aa et eae 69 Help TEMA A A hak ally E an SE 69 Historical Sensor Readings Viewing 0 0 cc eee eect een eens 114 FUER AQO east i deca ate td ate acer etek boty ohn th act ip oti aden ehh ae Beet e 31 Identification Required Dialog Box 0 cece eects 56 Input Impedance ii A eve eo Wee hg We hd Seed Roe a 150 Tipt Ranges aran Carne Eves Eee Erbe eek tae bee nee eee eee tee 151 Input Terminal Temperature Non Uniformity 2 0 0 0 0 c eee eee eee 151 Internal Memoria is Saal hoe Pees OLS eRe ee Os 20 Interval Average Screen eissii oriai o RA a e Ta n eee e nee eens 113 Interval Calculations screen podres res ersan e a E E E ene E 117 Interval Maximum Real Time Screen 6 0 cece eee nen 112 Interval Minimum Real Time Screen 2 0 0 eet 111 Interval Summary Screen 0 cece nent e nes 110 1117 Kaye Validator User s Manual 177 Index K Kaye MR o e en e e Dd 11 130 Installation A RT DA EA ed 32 Kaye Temperature Reference oooooooooorocrrrr etn e eens 11 Kaye Validator ui a a Ad Dia Gas rias 1 14 BN e e ban ela of o dd NA 2 Connecting rica is ii ii A A A iia 33 Control Kyrie ie acaba be pe ei eae Postel eee 16 Display Screen co dt ds ag 16 Floppy Disk Dinve 20 0 a e a Ea oan 4 Hardware isch coe ears adds 4 Hardware Connections iis es i
107. ord expiration date to the user at login when there are five days or less until their password expires 50 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 3 1a Setting up Site Options cont Disable user accounts after 3 unsuccessful login attempts This option will disable a user account if there are three consecutive PC login failures for the same user ID Ifa user s account is disabled the System Administrator must enable the account and assign a new temporary password This option does not affect logins from the Validator instrument panel Display a warning to calibrate the Kaye Validator in months Allow users to specify the D value for lethality equations Disable Validator disk recording When this option is enabled the Validator will not write data to a USB flash disk or floppy disk for PC controlled studies This option does not affect the loading of setups to the Validator via the disk drive e This option applies to PC controlled studies only A disk is always required for studies run in standalone mode When the option to disable disk recording is selected any setups loaded to the Validator or saved to disk from the PC program will be set to not record to disk This means that any setups currently saved on a disk will need to be moved to the PC program and loaded to the Validator or re saved to disk in order for the disable Validator disk recording option to take effect
108. orded for that SIM To rectify this power down reconnect the SIM and power back up 24 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 3 1 Wiring SIMs There are two methods for wiring SIMs You can assign sensor locations in your setup file and then wire the sensors according to the Setup Report or you can buy pre wired SIMs or wire the SIMs yourself and then create a setup that reflects the sensor locations This section shows you how to wire SIMs yourself IMPORTANT The SIM contains a static sensitive component that stores calibration information Use caution when connecting sensors GE Sensing recommends that you wear an anti static ground strap when connecting sensors and routing wires To connect sensors to SIM locations 1 Loosen the two screws in the top of the module to open a SIM Figure 6 below shows the inside of a SIM MESM Sew A AS AS Waist Harel cur 000000 RR PO tre i INS So Sy ithe AOS BC ESA Pere Ly Figure 6 SIM Wiring Legend 1 Tie wrap mounts 2 Connector locations 1 6 3 Sensing RTD 4 Connector locations 7 12 5 Sensor location number There are 12 connection locations labeled 1 12 witha positive and negative connector for each input 2 Loosen the two retaining screws where the sensor is to be inserted Kaye Validator User s Manual 25 Chapter 2 The Validator Hardware 2 3 1 Wiring SIMs cont 3 Connect your
109. ormation screen press Review Menu From the Setup Review screen press Main Menu Kaye Validator User s Manual 43 Chapter 2 The Validator Hardware 2 10Preventive Maintenance 2 10 1 Fuse Replacement The Validator is equipped with a 250V T 2A fuse The fuse is located in the line filter along with the power cord To replace the fuse 1 Turn the power off 2 Disconnect the power cord from the line filter 3 Using a small slotted screwdriver provided with the SIMs pry open the fuse holder from the bottom tab 4 Slide the fuse holder out and replace the fuse with a 250V T 2A replacement fuse 2 10 2 Calibration GE Sensing fully calibrates each Validator before shipment The equipment normally requires no further adjustment or calibration during installation Under normal operating conditions GE recommends you calibrate the Validator once a year to maintain peak system accuracy If you use a Validator for high accuracy measurements or if you replace or add circuit boards you may need to certify the calibration more often 2 10 3 Display Cleaning To clean the Validator display screen GE recommends that you use only a soft dry cloth Do not spray liquid cleaner on the screen 44 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 11Transporting and Shipping The Validator is designed to be easily transportable from one place to another within a plant The unit weighs approximately 20 pounds
110. overview of the Validator system e Chapter 2 explains the Validator hardware and provides instructions for connecting the system e Chapter 3 provides instructions for installing the software and creating user accounts e Chapter 4 provides instructions for calibrating sensors in standalone mode e Chapter 5 provides instructions for performing a qualification study in standalone mode e Chapter 6 provides instructions for performing calibration verification in standalone mode e Chapter 7 contains the Validator specifications Kaye Validator User s Manual 3 Chapter 1 The Kaye Validator 1 4 The Kaye Validator System The Kaye Validator system integrates hardware and software and gives you the flexibility to design and run studies in the way you find most productive This section provides an overview of the system and its use 1 4 1 The Validator Hardware The Validator is a self contained instrument incorporating high accuracy sensor measurement hardware with secure data recording capability The Validator provides standalone functionality when calibrating sensors and running qualification studies Figure 1 The Validator Unit The Validator accepts up to 36 inputs in any combination of thermocouple voltage or current inputs The instrument is equipped with a universal power supply 100 240 VAC and connections for two Kaye temperature standards although only one standard can be used at any given time one Kaye temp
111. p List Steam Sterilizer John Doe 03 Apr 2005 Mon 10 34 55 John Doe 31 Apr 2005 Fri 14 32 44 Distribution Study John Doe 31 Apr 2005 Fri 14 02 25 y Main Menu Figure 61 Setup List 6 Ifthere are multiple setups on the disk use the up and down arrow keys on the Validator keypad or the Next and Prev buttons on the Setup List screen to select your setup The pointer gt appears to the left of the selected setup In this example the Steam Sterilizer setup will be loaded 7 Press Load It takes a few seconds for the Validator to load the setup When complete the Sensor Inputs Real Time screen displays Now that your setup is loaded into the Validator you are ready to run your qualification study 100 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 1 Starting the Qualification Study You can start your qualification study automatically or manually depending on the start qualification condition defined in your setup See Specifying Start Stop Conditions in the Validator online Help for more information Before you start your qualification study make sure you have a new formatted USB flash or floppy disk in the disk drive If you are printing qualification data to an attached printer make sure the printer is connected to the Validator and powered on Note You can pause data recording at any time during the qualification study to change the disk add paper to the attached printer or
112. p are different than the calibration parameters or temperature units of the setup currently in memory Sensor Calibration Automatic Stabilizing Low Setpoint 89 861C 90 00C Elapsed Time 0000 00 00 TEMP STABILITY 89 98C 89 97C 89 98C 89 96C Criteria Figure 49 Sensor Calibration Screen Note Calibration offsets for sensors at each setpoint are written to the SIM when the calibration process is complete If you stop calibration calibration offsets already calculated are not written to the SIMs and the calibration report file is deleted For example if you have completed low setpoint calibration and then stop the calibration process during high setpoint calibration the sensors are marked UNCAL D in the SIMs and the calibration report file is deleted Calculating Stability The first step in the calibration process is to verify that the sensors and IRTD are stable Stability is the maximum allowable change in temperature for each sensor and the temperature standard over a specified time interval The maximum allowable change in temperature for the IRTD is fixed at 0 012 C 0 022 F if all temperature setpoints are equal to or greater than 0 0 C 32 0 F If any temperature setpoint is less than 0 0 C 32 0 F you can enter the IRTD stability value manually in your setup 84 Kaye Validator User s Manual Chapter 4 Calibrating Sensors 4 2 3 Calibrating Sensors cont The stability calculation begins once the
113. pecify how often to save and or print qualification data Define the output relay After you have created and saved your setup you run the study by loading the setup into the Validator via USB flash or floppy disk or by direct connection from your PC to the Validator See the Validator online Help for instructions on setting up a study 10 Kaye Validator User s Manual Chapter 1 The Kaye Validator 1 5 5 Sensor Calibration The Validator provides both pre qualification sensor calibration and post qualification calibration verification Before you perform a qualification study you should calibrate the temperature sensors to correct raw temperature readings to a traceable temperature standard You can perform a one point calibration a two point calibration or a two point calibration and a one point check Sensors that do not meet the pre qualification calibration test criteria are marked as failed and are not calibrated Sensors that fail calibration cannot be used in a qualification study After the qualification study you can perform a post qualification verification to verify that the sensor readings are still within the calibration criteria You can perform a one point two point or three point post qualification verification If a sensor fails post qualification verification the sensor is noted as failed but the readings are still reported Calibration offsets are not changed during post qualification verification You can cali
114. r to execute the file 6 Install the Validator software A 2 Turning On the UAC After you have completed the above steps repeat step 1 to turn the UAC back on by checking Use User Account Control UAC to help protect your computer and clicking OK You will need to restart your computer again 156 Kaye Validator User s Manual Appendix A Installing Kaye Validator on the Windows Vista Operating System A 3 Adding the GE Sensing User Group 1 From the Start menu go to Control Panel gt System and Maintenance gt Administrative Tools Figure 102 below Goa Control Panel System and Maintenance Kaye Validator User s Manual Control Panel Home System and Maintenance Security Network and Internet Hardware and Sound Programs Mobile PC User Accounts Appearance and Personalization Clock Language and Region Ease of Access Additional Options Classic View Recent Tasks Turn User Account Control UAC on or off Add or remove user accounts Uninstall a program P mme ere epee re ee ee See the name of this computer errr eee Windows Update Turn automatic updating on or off Checkforupdates View installed updates Power Options Change battery settings Require a password when the computer wakes Change what the power buttons do Change when the computer sleeps Indexing Options Change how Windows searches Problem Reports and Solutions Check for new solutions Choose
115. r Connecting 00 ccc eee nen eens 30 Kaye Validator User s Manual 175 Index D Data Recording Pausin gs rs a ek Re EE 127 Data Requirements croc ita eee dae A ER a iO nae ed 9 Deviation of Calibrated Sensors 0 ccc cece cnet een n ees 86 Deviation of Uncalibrated Sensors 00 ccc tenes 85 Display Screen tn ena eee BE ad of Wael a ill Wee Sees 16 Cleaning a penn tine namo oe ers Sie di oe ate ae he ee 44 Disposal Batteries nata ed Aba oR aca tide ti 172 Electronic Waste iii A ue a a EE hd 171 E Environmental Temperature 0 00 eect nee eens 151 Event Definitions CE ss prne in eased dace A Pals wale ade 117 Event Messages Scream A Oke nde ale ae oe NE SAGs ead es 107 Events VieWING ceci AE baw he ea OT Maat te 105 Exposure Cycle Starting Automatica nn A A E a 118 Manually a a da aaa aa 118 F Fl Function Key o A ek OE ev 69 FDA LGU e Mes cria a Ar A AI a Sy Mallen 2 FDA Regla OHS x62 icss do 2 Bac wand aan he ede wes Seeds 9 Flash Drive Interfaces ccc lios 4 118 Floppy Disk Drives a lt lt ste sar ed aaa a Wala die a 4 118 Floppy Disk Recording Disablidg oooooooororrrrnrrrrr ene es 51 Floppy Disk Selecting 23 ii ioe ee Gosden a lali 78 Fuse Ratin a 6 sa dee it te bet aed di tne eh ada 152 Fuse Replacement ia a die ata 44 G Group Event Screen sc ic eae aed Fates Se Ras eRe de ee es eee we 117 176 Kaye Validator User s Manual H Hardware Connections o
116. r for User ID entry Require minimum length password 180 BE Expire passwords days I Disable user account after 3 consecutive login failures E Display User ID during entry T Disable password system Other Reporting 12 4 X Instrument calibration warning months I Disable spreadsheet export T Allow editing of D value in lethality equation T Disable graphing T Disable Validator disk recording Cancel DK Reporting elated options selections and changes are not audited Figure 25 System Administrator Site Options 3 3 1a Setting up Site Options The Site Options screen lists nine options that give users more flexibility while running the Validator software These options are not mutually exclusive You can enable any combination that your site supports As the System Administrator you can enable options that will Seta login timer for user identification The login timer allows users after initial identification to enter only their password if user identification is within the preset time limit When this option is enabled the login timer can be set from 1 to 15 minutes Require minimum length passwords for all user accounts from 6 to 16 characters Set passwords to expire after a number of days up to 366 The user will be prompted to change their password once their current password has expired By default passwords are set to expire after 90 days The software will display the passw
117. readings of your thermocouples This chapter provides instructions on performing a standalone sensor calibration For instructions on performing a PC controlled sensor calibration see the Validator online Help 72 Kaye Validator User s Manual Chapter 4 Calibrating Sensors 4 2 Performing a Standalone Calibration You can perform standalone calibration only if your validation system includes a Kaye temperature reference and IRTD The Validator automatically sets the temperature reference to the specified setpoint Low High Check and automatically reads the value of the IRTD at that setpoint In this section you e Load a setup into the Validator e Select sensors to calibrate e Run calibration 4 2 1 Loading a Setup The first screen you see after the unit has been powered up is the Validator screen This screen lists the setup currently loaded in the Validator If the Validator screen is not the current screen press Main Menu From the Main Menu press Setup Review and then press Summary The currently loaded setup displays on the Validator screen shown in Figure 38 below Kaye Validator Setup Default Setup Date 28 Jan 05 G1 Distribution G2 Penetration G3 Pressure G4 Contact Copyright 1998 2006 GE Sensing Main Menu Figure 38 Summary Screen Kaye Validator User s Manual 73 Chapter 4 Calibrating Sensors 4 2 Loading a Setup cont If the setup loaded in the Validator is the one
118. reate and maintain user accounts and set site options A default System Administrator account is included with the software You use this account to initially log in to the Password Maintenance utility and create your own System Administrator account The default account is deleted once your own System Administrator account is created You can then use your own account to perform all your system administration tasks In this chapter you Install the Validator software configured for network or local applications Start the program and log in to the Password Maintenance utility using the default System Administrator account Set site options e Create your System Administrator account Create Supervisor and Operator accounts Print the active user list Select the Communications Port Access the Validator online Help Kaye Validator User s Manual 47 Chapter 3 Installing the Software and Creating User Accounts 3 2 PC Requirements To run the Validator Windows based software your PC should meet the following minimum requirements e Pentium microprocessor with 300 MHz processor speed and at least 256 MB RAM e Microsoft Windows 2000 XP or Vista Business SP1 32bit Note To install Validator software under Vista please refer to Appendix A e Microsoft Office 2000 2003 XP or 2007 One unused serial port or USB port for communicating with the Validator hardware do not configure any other programs e g P
119. reen displays as shown in Figure 82 below In this example the message description refers to the disk drive System Message MESSAGE TIME 3 Feb 2005 Mon 14 07 19 MESSAGE LEVEL Warning Continue MESSAGE DESCRIPTION Floppy paused by user Press Resume to continue reporting QUAL 1 Figure 82 System Message Paused Disk 4 If you paused data recording to disk remove the disk from the disk drive insert the new disk into the disk drive and press Continue 5 If you paused data recording to the printer add paper and or correct the printer problem and press Continue 128 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 8 Pausing Data Recording During the Qualification Study cont The Hardware Controls screen displays as shown in Figure 83 below Hardware Controls Increase Contrast Decrease Contrast Resume Disk Pause Printer Engineering Log Main Menu Figure 83 Hardware Controls 6 Resume data recording to the disk drive or to the attached printer e If you paused data recording to the disk drive press Resume Disk Ifyou paused data recording to the attached printer press Resume Printer 7 Press Main Menu The Main Menu screen displays 8 Press Home to return to the last real time screen that was displayed Kaye Validator User s Manual 129 Chapter 5 The Qualification Study no content intended for this page proceed to next page 130 Kaye Validator User
120. ress ENTER The Password Operations screen displays as shown in Figure 6 3 on the next page Kaye Validator User s Manual 135 Chapter 6 Calibration Verification __E __AAeCQT Y gt e PEE EOOOAEEREECQAEOEO A E 6 2 1 Loading a Setup cont Password Operations Load Setup Calibrate Sensors Start Qualification Select Floppy Disk Storage Main Menu Figure 86 Password Operations Screen 5 Press Load Setup The Validator displays the setup files that reside on the disk and for each setup displays the setup name the name of the Supervisor who last saved the setup and the date and time the setup was saved on the Setup List screen shown in Figure 87 on the next page The setup names are displayed in reverse video 136 Kaye Validator User s Manual Chapter 6 Calibration Verification 6 2 1 Loading a Setup cont Setup List Steam Sterilizer John Doe 03 Apr 2005 Mon 10 34 55 John Doe 31 Apr 2005 Fri 14 32 44 Distribution Study John Doe 31 Apr 2005 Fri 14 02 25 y Main Menu Figure 87 Setup List Screen 6 Ifthere are multiple setups on the disk use the up and down arrow keys on the Validator keypad or the Next and Prev buttons on the Setup List screen to select your setup The pointer gt appears to the left of the selected setup 7 Press Load It takes a few seconds for the Validator to load the setup When complete the Sensor Inputs Real Time screen displays The next st
121. rification 6 2 3 Verifying Sensor Calibration cont Note You can display the temperature setpoints and the stability and deviation criteria defined for this setup at any time by pressing Criteria on the Calibration Verification screen Press Sensor Cal to redisplay the sensor readings 6 2 3b Calculating Deviation of Calibrated Sensors When the IRTD and all sensors reach stability the Validator calculates calibrated deviation by comparing each sensor to the IRTD and then logs the stability and calibrated deviation evaluation data to the calibration verification report file The corrected results for each sensor are then compared to the IRTD and logged and displayed every 30 seconds for the time period specified in the setup Sensors that fail the calibrated deviation evaluation are displayed in reverse video and marked as failed in the calibration verification report file 6 2 3c Data Logging Complete at Setpoint When the Validator finishes logging the corrected results at the low setpoint it automatically sets the Kaye temperature reference to the high setpoint and repeats the calibration verification process When the Validator finishes logging the corrected results at the high setpoint it automatically sets the Kaye temperature reference to the check setpoint and repeats the calibration verification process Kaye Validator User s Manual 143 Chapter 6 Calibration Verification 6 2 3 Verifying Sensor Calibration
122. rify press Reselect and repeat steps 5 and 6 Now you are ready to verify that the sensors still meet their calibration criteria 140 Kaye Validator User s Manual Chapter 6 Calibration Verification 6 2 3 Verifying Sensor Calibration The Validator automatically checks the sensor readings at the verification setpoints defined in your setup Calibration offsets stored in the SIMs are not changed during calibration verification Before starting calibration verification make sure you have a disk in the disk drive If you are printing calibration verification data to an attached printer make sure the printer is connected to the Validator and powered on In the following example you perform a three point calibration verification low setpoint high setpoint check setpoint To verify sensor calibration 1 From the Sensor Confirmation screen shown in Figure 90 on the previous page press Run Verification The Validator establishes communications with the temperature reference and the IRTD When this is accomplished the Calibration Verification screen displays The sensor locations and IRTD title display in reverse video until they reach stability Calibration Verification Automatic Stabilizing Low Setpoint 89 961C 90 00C Elapsed Time 0000 00 00 TEMP STABILITY 89 98C 89 97C 89 98C 89 96C Criteria Figure 91 Calibration Verification Screen Kaye Validator User s Manual 141 Chapter 6 Calibration Veri
123. roximately inch in order to make the connection with the connector to o Figure 8 Thermocouple Connections Always connect the positive lead to the positive connector and the negative lead to the negative connector The negative thermocouple lead is normally red in conformance with ANSI standards Moist Heat Environments When validating moist heat processes a sealed PTFE tip thermocouple should be used with a drip cut shown in Figure 9 below on the outer insulation close to the SIM module to reduce the possibility of drawing moisture into the SIM To add a drip cut remove 4 inches 10 cm of the outer insulation from each thermocouple at a point where natural drainage can take place without water reaching the terminal screws see Figure 9 below Kaye Validator User s Manual 27 Chapter 2 The Validator Hardware 2 3 1a Connecting a Thermocouple cont Also GE recommends shaving open about 1 4 inch from each of the red and blue inner wire jackets at opposite ends of the outer insulation drip cut to allow condensate drainage from within the individual wires as shown in Figure 10 below Figure 10 Shaving from Inner Wire Jackets If moisture does collect in the SIM remove the SIM from the instrument open and allow to air dry before storage 28 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 3 16 Connecting a Contact You can connect dry contact inputs dir
124. rpose is to save a new user table only to the disk Transfer the new disk to the Validator instrument s USB flash or floppy drive The Validator should be displaying a message confirming disk recording has been paused Press Continue On the Hardware Controls screen press Resume Disk Press the blue security key The System Login screen appears Enter the updated user ID and password At the Password Operations screen press Stop Qualification Your qualification study data is now saved on two flash or floppy disks Kaye Validator User s Manual 65 Chapter 3 Installing the Software and Creating User Accounts 3 7 Selecting a Communications Port Note Jfyou have installed Kaye Validator from a network the communications port may have been already selected You must have appropriate permissions to modify preferences You must select a communications port in order for the Validator to communicate with your PC To select a communications port 1 Click Start gt Programs gt Kaye Validator gt Kaye Validator 2 Click the Preferences tab at the top of the screen The Identification Required dialog box displays shown in Figure 35 below Identification Required User ID J Current Password J FT Change Password Figure 35 Identification Required Dialog Box 3 Enter your user ID and the password supplied by your System Administrator and click OK If you are entering the program for the first time
125. rted with Window Back up and restore files and system jemove user accounts Back up your computer settings view RAM and processor speed check performance update software and drivers and more ce and ersonalization Change desktop background Customize colors Adjust screen resolution Security Check for updates Check this computer s security status e Allow a program through Windows Firewall Network and Internet Clock Language and Region View network status and tasks f Change keyboards or other input Set up file sharing methods Hardware and Sound pase of Access Play CDs or other media automatically PAL RCRA Pa p Optimize visual display nnter Mouse Additional Options Programs Recent Tasks Uninstall e program uin User Account i Change startup programs i Figure 98 Control Panel Window The screen shown in Figure 99 below appears go gt Control Panel uad Do you want to help improve Control Panel search results By choosing to send your search queries to Microsoft you can help improve search results Information that is collected will not be used to identify or contact you Please read our Privacy Statement online l Yes No User Accounts Turn User Account Control UAC on or off Search Windows Help and Support for uac Figure 99 User Accounts Window 154 Kaye Validator User s Manual Appendix A Installing Kaye Validator on the Windows Vista Operating System
126. s 71 4 1 1 Preliminary Steps e A a ect t tenet tenes 72 4 2 Performing a Standalone Calibration 0 0 eee cnet e nee 73 4 2 Loading ASUS ses UROL SRS ROR A Poe ae 73 4 2 1 Selecting the Disk Storage 0 0 ete tenes 78 422 Selecting Sensors neers eee tart ens Ree EE ER 80 423 Calibrating Sensors td dieu hee etd ded eats leet 83 4 2 4 Rewrite Report to Disk 2 00 tenet nnn nee 87 4 2 5 Viewing Calibration Offsets 0 00 0 eee eens 90 Chapter 5 The Qualification Study 5 1 Introduction sci Bg uke ei ES A eos ees poet 93 5 2 Performing a Standalone Qualification Study 0 ect eee ee 95 52 1 Loading a Setup erae a eb tad dct aa e a e a tt belt dle dd led Ah 96 5 2 1 Starting the Qualification Study 0 20 0 eee eee 101 5 2 laStarting the Qualification Study Automatically 0 00 00 00s 101 5 2 1bStarting the Qualification Study Manually 2 0 0 0 0 cee eee eee 102 5 2 2 Viewing Real Time Sensor Readings Calculations and Events 103 5 2 1 Viewing Real Time Sensor Readings 00 cece ee cece eee ene 104 5 2 2 Viewing Real Time Calculations and Events 2 0 0 cee cee eee eee ee 105 5 2 3 Viewing Historical Sensor Readings Calculations and Events 114 52 4 Reviewing Setup Data cia Aaa read 115 5 2 5 Starting and Stopping the Exposure Cycle 1 0 0 eee cece ee ee 118 5 2 5aStarting and Stopping the Exposure
127. s Manual Chapter 6 Calibration Verification Chapter 6 Calibration Verification 6 1 Introduction After your qualification study is complete you can perform calibration verification to verify that your thermocouple readings are within the specified calibration criteria The Validator can perform standalone or PC controlled calibration verification e You can perform standalone calibration verification only if your validation system includes a Kaye temperature reference and IRTD e You can perform PC controlled calibration verification automatically if your validation system includes a Kaye temperature reference and IRTD or manually if your validation system does not include a Kaye temperature reference and or IRTD IMPORTANT The Validator is designed to run either as a standalone instrument or PC controlled When verifying calibration all major actions should be consistent If the PC is connected you should control calibration verification from your PC During calibration verification you can use the PC and or the Validator to view data and track your progress The Validator uses the calibration verification parameters defined in your setup to specify the temperature reference setpoints at which calibration verification is performed The stability and calibrated deviation criteria for the temperature sensors and the temperature standard are the same for calibration and calibration verification See Specifying Calibration Parameters
128. s enabled the Disable Validator disk recording site option See Setting Site Options in Chapter 3 When calibration is complete the Validator writes the calibration offsets the serial number of the Validator measurement board where calibration was performed and the SIM slot number to the SIMs If a sensor fails at the low high or check setpoint it is marked as failed in the SIM and in the calibration report file 4 1 1 Preliminary Steps Before you begin the calibration process Place the Validator in a location with stable and even temperature not exposed to any local heat sources 1 e close to a sterilizer an open door causing a draft etc Temperature variations and or exposure to external heat sources during calibration may cause temporary temperature measurement errors To provide maximum accuracy during the calibration process power up the Validator and let it run for approximately 30 minutes in the operating environment where calibration is to be performed in order for the Validator to acclimate to the ambient temperature Place the temperature sensors and the IRTD into the temperature reference The temperature reference provides the stable temperature required for sensor calibration The IRTD a self contained precision measurement standard that provides data directly to the Validator accurately measures the temperature of the reference The IRTD provides a traceable standard that is used to correct the temperature
129. s saved the System Message screen displays with a verification message as shown in Figure 54 on the next page 88 Kaye Validator User s Manual Chapter 4 Calibrating Sensors 4 2 4 Rewrite Report to Disk cont System Message MESSAGE TIME 13 Apr 2005 Tues 10 49 51 Continue Floppy Disk Recording Complete Verification Status PASSED Figure 54 Message Screen with Verification Status Kaye Validator User s Manual 89 Chapter 4 Calibrating Sensors 4 2 5 Viewing Calibration Offsets Calibration offsets are stored in the SIM s memory You can view the calibration offsets on the Sensor Definitions screen To view calibration offsets 1 From the Sensor Inputs Real Time screen press Main Menu The Main Menu screen displays as shown in Figure 55 below Main Menu Real time Data Historical Data Setup Review Hardware Controls Figure 55 Main Menu Screen 2 Press Setup Review The Setup Review screen displays as shown in Figure 56 on the next page 90 Kaye Validator User s Manual Chapter 4 Calibrating Sensors 4 2 5 Viewing Calibration Offsets cont Setup Review Sensor Definitions Calculations and Events Calibration Information Summary Main Menu Figure 56 Setup Review Screen Kaye Validator User s Manual 91 Chapter 4 Calibrating Sensors 4 2 5 Viewing Calibration Offsets cont 3 Press Sensor Definitions The Sensor Definitions screen shown in Fig
130. st in internal memory Kaye Validator User s Manual 97 Chapter 5 The Qualification Study 5 2 Performing a Standalone Qualification Study cont When the Validator finishes comparing the machine IDs and user lists the System Login screen displays as shown in Figure 59 below System Login User ID gt Password Figure 59 The System Login Screen 3 Key in your user ID and press ENTER 4 Key in your password and press ENTER 98 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 Performing a Standalone Qualification Study cont The Password Operations screen displays as shown in Figure 60 below Password Operations Load Setup Calibrate Sensors Start Qualification Select Floppy Disk Storage Main Menu Figure 60 Password Operations Note Ifthe setup currently loaded has an automatic start qualification condition Auto Start of Qualification replaces Start Qualification on the Password Operations screen 5 Press Load Setup Kaye Validator User s Manual 99 Chapter 5 The Qualification Study 5 2 Performing a Standalone Qualification Study cont The Validator displays the setup files that reside on the disk and for each setup displays the setup name the name of the Supervisor who last saved the setup and the date and time the setup was saved on the Setup List screen The setup names are displayed in reverse video as shown in Figure 61 below Setu
131. st will show installed driver software compatible with the device and all driver software in the same category as the device Figure 116 Browsing for Driver Software Kaye Validator User s Manual 167 Appendix A Installing Kaye Validator on the Windows Vista Operating System A 4 Installing the USB Patch for VISTA Systems cont 8 Select Install this Driver software anyway Figure 117 below Update Drover Software Unknown Device Installing driver software Don t install this driver software You thed check your manufacturer s webste for updated driver software for your device Figure 117 Installing Driver Software 9 After a few seconds the screen shown in Figure 118 below opens wy n Update Driver Software GE Validator 2000 COM3 Windows has successfully updated your driver software Windows has finished installing the driver software for this device GE Validator 2000 Figure 118 Successful Installation Screen 168 Kaye Validator User s Manual Appendix A Installing Kaye Validator on the Windows Vista Operating System A 4 Installing the USB Patch for VISTA Systems cont 10 Click Close and the Device Manager Figure 119 below should be updated with GE Validator 2000 ile Action Yiew Help e m OA m din VISTA PC y AF Computer P cs Disk drives p My Display adapters E DVD CD ROM drives eal Floppy disk drives E aif Floppy drive controllers o 29 Human Interface
132. stribution Time Wed 14 44 40 MAX TIME 89 98 C Wed 14 43 25 89 99 C Wed 14 43 05 89 99 C Wed 14 44 30 89 96 C Wed 14 45 40 89 94 C Wed 14 43 15 89 98 C Wed 14 44 10 QUAL 1 Main Menu Figure 69 Interval Maximum Screen The Interval Maximum Real Time screen displays the maximum readings for each sensor in the selected group during the specified interval and the time the maximum reading occurred for each individual sensor 8 Press the right arrow key 112 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 2 Viewing Real Time Calculations and Events cont The Interval Average Real Time screen displays as shown in Figure 70 below Interval Average Real Time Group Distribution Time Wed 14 46 00 AVG 89 91 C 89 82 C 89 90 C 89 89 C 89 91 C 89 98 C QUAL 1 Main Menu Figure 70 Interval Average Screen The Interval Average Real Time screen displays the average readings for each sensor in the selected group for the specified interval Note You can press the right arrow key to return to the Sensor Inputs Real Time screen or press the left arrow key to scroll back through the display screens Kaye Validator User s Manual 113 Chapter 5 The Qualification Study 5 2 3 Viewing Historical Sensor Readings Calculations and Events During the qualification study and for as long as the current setup remains in memory you can view historical sensor readings calcula
133. ted users To change your default printer From the Password Maintenance screen select File gt Print Setup Select a new printer from the list and click OK The Password Maintenance screen displays Select File gt Exit to exit the Password Maintenance utility Kaye Validator User s Manual 63 Chapter 3 Installing the Software and Creating User Accounts 3 6 Standalone Passwords Once user accounts are created by the System Administrator with the Validator software users running the Validator instrument in standalone mode can enter their user ID and password at the Validator instrument panel to run qualification studies verify sensor calibration and calibrate sensors provided that the user ID and password consist of numbers from 1 5 and the user has activated their account by creating a password through the PC program If users are running the Validator in standalone mode with the password expiration site option enabled steps should be taken to ensure that users have the ability to change their passwords before they expire The Validator firmware will reject expired passwords users will need access to the Validator software in order to update them A setup will need to be copied again to USB flash or floppy disk and transferred to the Validator instrument or re loaded directly to the Validator from the PC in order for the firmware to read the new user table with the updated password information GE recommends informing sta
134. temperature reference is within 5 degrees of the low setpoint Stability is computed at the scan rate To achieve stability the IRTD and all sensors must meet the stability criteria defined in the setup The IRTD and sensors display in normal video when they reach stability If any sensors fail to reach stability the calibration process remains here To end the calibration process press STOP Note You can display the temperature setpoints and the stability and deviation criteria defined for this setup at any time by pressing Criteria on the Sensor Calibration screen as shown in Figure 50 below Press Sensor Cal to redisplay the sensor readings Sensor Calibration Automatic Stabilizing Low Setpoint 89 861C 90 00C Elapsed Time 0000 00 30 TEMP STABILITY 89 94C 0 02C 89 99C 0 03C 89 93C 0 03C 89 92C 0 01C Criteria Figure 50 Sensor Calibration Screen Calculating Deviation of Uncalibrated Sensors When the IRTD and all sensors reach stability the Validator calculates uncalibrated deviation by comparing each sensor to the IRTD and then logs the stability and uncalibrated deviation data to the calibration report file The Validator marks any sensor outside the deviation criteria as failed When uncalibrated deviation is complete the Validator calibrates the sensors at the low setpoint Kaye Validator User s Manual 85 Chapter 4 Calibrating Sensors 4 2 3 Calibrating Sensors cont Calculating Deviation of Calibrated
135. th a NiCad backup battery to provide short term power in case of AC power loss The intent of the battery is to provide sufficient time approximately 30 minutes so that you can perform an orderly shutdown of the system When the Validator detects that the AC power has failed and the system is running from battery it issues a message and then disables the Validator display backlight You can momentarily re enable the backlight by pressing any key on the unit IMPORTANT In the event of power glitches or short term drops in supply voltage brownouts there is a remote chance that the Validator will fail to fall back to its backup battery In this case the Validator will reset and potentially lose any study data stored in internal memory To prevent this from occurring GE recommends connecting the Validator to an Uninterruptible Power Supply UPS in areas likely to experience brownouts CAUTION Power is still supplied to the unit via the backup battery after the AC power cord is unplugged Disconnect the W2005 cable from the battery pack before servicing the instrument The Validator monitors its own battery voltage When the battery has approximately one minute of power remaining the Validator stops collecting data and closes its data files To ensure long service life and minimize the memory effect inherent in NiCad batteries it is a good practice to completely discharge and recharge the NiCad battery on a periodic basis 22 K
136. the Validator will fail to fall back to its backup battery In this case the Validator will reset and potentially lose any study data stored in internal memory To prevent this from occurring Kaye recommends connecting the Validator to an Uninterruptible Power Supply UPS in areas likely to experience brownouts When the qualification study 1s complete you can generate reports to document the specifics of your study using the Validator report generator See the Validator online Help for more information on generating reports 94 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 1 Introduction cont Before you begin your qualification study Place the Validator in a location with stable and even temperature not exposed to any local heat sources 1 e close to a sterilizer an open door causing a draft etc Temperature variations and or exposure to external heat sources during qualification studies may cause temporary temperature measurement errors To provide maximum accuracy during the qualification study power up the Validator and let it run for approximately 30 minutes in the operating environment where qualification is to be performed in order for the Validator to acclimate to the ambient temperature Position your sensors in the vessel or chamber being tested This chapter provides instructions on performing a standalone qualification study For instructions on performing a PC controlled qualifi
137. the user to the Validator software The name you enter here appears in the active user list IMPORTANT User IDs must be unique Once an ID has been used it cannot be used again 4 Enter the new user identification in the User ID text box The user ID can be any combination of numbers and characters up to a maximum of 16 The user ID and password are case sensitive A user ID may not be used by more than one active account 60 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 5 Creating User Accounts cont 5 6 Enter a temporary password for the user in the Password text box The password can be any combination of numbers and characters up to a maximum of 16 The user will change this password when they first log in to the program Enter the temporary password again in the Confirm password text box IMPORTANT Jf this user plans to use the Validator hardware in standalone mode use the numbers 1 5 only for the user ID and inform the user to enter numbers from 1 5 when they create their permanent password Standalone mode accepts the numbers 1 5 only At this point you should record the new user ID and temporary password You will need to supply this information to all new users A user ID and password is required any time a user Changes preferences if the System Administrator has enabled the user to modify preferences then other users can change preferences other
138. ti ee tai es AGW a da Ras Seals 6 Mal MEU ei ake Ale A lave ana AE aly eet As olde 58 Memory nace a AAA apa Mees AR WEA Gee RS 20 PGC Connector it eas dee Os Deh eee RS Ed EAS Oe Od cs enw Es a 19 Setting Time dd Dec A A Rik aoe wie eA RE OE Hae ee 34 SHIPPING hee oot eves iS OE ee eee eee We ee es 45 SOMWALE ct A A AS A eee 7 Software Installation onPC o oooooooooroorrrrrr 49 150 155 Software Requirements o oooooooooo cette nent n ene 48 Software Uninstalling so dci aces id Ma ace Weal oan wl AES Bete wae 69 SATU GS osc 5 bee A aldaid Mh atestad es alah k a ii 56 System Componemts A SER Ae Bean ae eee aes 1 US ACCESS Sane Lae a 7 L Lethality Calculations Real Time Screen 1 0 2 2 0000s 105 Lethality Calculations Screen 0 keene teen eens 117 Login Mea ee a eed Wk el aR ates 50 EER ZSAE e e ad dd ent et nian See a AA ane ad 31 EFR 40 140 0 nata ch duet ona igre Deters a a a 31 178 Kaye Validator User s Manual Index M Main Menu On Validator OE A A E A E 90 Main Menu PC Software yeer oeie eae a aE E eee ene e nen n ees 58 Manual OVERVIEW 238 S85 A ES RS SRE RRS BS ORS SOS RS BES Sots 3 Max Common Mode Voltage 0 0 ect teens 151 Menu Keys cis pose A bos ee oo aw ee gee A a 17 N Navigational Keysi ai hi ae as BRE ON EBS OER ws Se ed Sele Rie es 17 Normal Mode Rejection 0 0 0 ec ccc E a VEA n teens 151 O Operator at ia A ale E RAET 7 Operator Account Creatin A A E ERAS Ai ae AS
139. tion studies all major actions should be consistent If the PC is connected you should control your qualification study from your PC During the qualification study you can use the PC and or the Validator to view data and track your progress The Validator uses the qualification parameters defined in your setup to perform the qualification study Depending on the start and stop qualification conditions and the start and stop exposure conditions defined in your setup you can perform a fully automatic qualification study a fully manual qualification study or a mixture of automatic and manual For example you could specify in your setup that the qualification study starts manually exposure starts automatically when a contact closes exposure ends automatically when the contact opens and qualification ends manually During the qualification study the Validator performs calculations and compiles data for your reports Qualification data is written to internal memory the USB flash or floppy disk drive the PC hard drive 1f this is a PC controlled study and the Validator printer 1f attached You can collect data over multiple disks during the qualification run allowing you unlimited data storage Note Data will not be written to the disk drive for PC controlled studies if the System Administrator has enabled the Disable Validator disk recording site option See Setting Site Options in Chapter 3 Kaye Validator User s Manual 93 Chapter
140. tions and events Historical data is presented in the same format as the real time data the only difference being that the historic screens are time stamped with the time of data collection Note Data is no longer available if the unit is powered off or if you load a new setup To view historical data 1 From the Main Menu press Historical Data The Sensor Inputs History screen displays 2 Press the down arrow key on the Validator keypad to scroll back in time through the historical sensor readings Press the up arrow key on the keypad to scroll forward in time Data is displayed at the scan rate defined for the current setup Note lIfthere are more sensors than appear on the screen press the up or down arrow keys to scroll through the data for that time stamp When you reach the top or bottom of the sensor list the next time you press the arrow key the timestamp will change 3 From the Sensor Inputs History screen press the right arrow key on the Validator keypad to scroll through the historical calculations screens and event messages screen 114 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 4 Reviewing Setup Data You can review the setup before during and after the qualification study The qualification run number displays at the bottom of each screen when you review setup data during the qualification study To review setup data 1 From any screen press Main Menu The Main Menu screen
141. tions registering the maximum and minimum temperatures each scan 4 Press the right arrow key 108 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 2 Viewing Real Time Calculations and Events cont The Saturated Steam Real Time screen displays as shown in Figure 66 below Saturated Steam Real Time Group Distribution Time Wed 14 43 00 Calculated Sat Pressure 10 15 from Temperature 89 95 C Loc l 04 QUAL 1 Main Menu Figure 66 Saturated Steam Real Time The Saturated Steam Real Time screen displays the saturated temperature of steam and the saturated pressure of steam for the selected group e The saturation temperature of steam calculation uses a pressure input from a specified location to calculate the equivalent saturated temperature of steam The saturation pressure of steam calculation uses a temperature input from a specified location to calculate the equivalent saturated pressure of steam 5 Press the right arrow key Kaye Validator User s Manual 109 Chapter 5 The Qualification Study 5 2 2 Viewing Real Time Calculations and Events cont The Interval Summary Real Time screen displays as shown in Figure 67 below Interval Summary Real Time Group Distribution Time Wed 14 43 35 Interval Start Wed 14 42 25 VALUE LOC TIME Min 89 83 1 03 Wed 14 42 55 Max 90 11 1 04 Wed 14 43 30 Interval Duration 0000 01 10 QUAL 1 Main Menu Figure
142. to generate reports containing only the results you need to document your study You can also export qualification data to an Excel spreadsheet file for further analysis 1 5 1 User Access You can set user access to the Validator to match the way your company works The Validator software is designed for three levels of users Each user level has specific permissions that define system access Permissions can also be customized for each user System Administrator Responsible for the security of the program The System Administrator creates and maintains user accounts sets site options and backs up and restores user information Supervisor Creates and modifies setups calibrates sensors runs qualification studies and generates reports Supervisors can also change system preferences if the System Administrator has enabled the Allow Supervisors to change Preferences site option Operator Uses prepared setups to calibrate sensors run qualification studies and generate reports Operators cannot change setups or system preferences Kaye Validator User s Manual 7 Chapter 1 The Kaye Validator 1 5 2 User Identification Each user is assigned two distinct levels of identification user ID and password which are used to uniquely identify an authorized Validator user Each user ID is associated with a unique user name to provide traceability during the validation process The Validator requires users to enter their user ID and
143. tor keypad to position the pointer on the individual sensor and press Select An asterisk appears to the right of the selected sensor indicating this sensor is to be calibrated To select all sensors in one step use the up and down arrow keys on the Validator keypad to position the pointer on All Sensors and press Select An asterisk appears to the right of each sensor indicating all sensors are to be calibrated Note You can deselect sensors individually or deselect all sensors in one step using the Deselect button In the example shown in Figure 46 below sensors 1 01 through 1 04 have been selected Sensor Selection gt All Sensors Criteria Temp 01 Temp 02 Select Temp 03 Temp 04 Deselect Temp 05 Temp 06 Continue Temp 07 Temp 08 Main Menu Figure 46 Sensor Selection Screen 5 After you have selected the sensors to calibrate press Continue Kaye Validator User s Manual 81 Chapter 4 Calibrating Sensors E A AA Quo gt e 4 2 2 Selecting Sensors cont The Sensor Confirmation screen shown in Figure 47 below displays This screen lists all the sensors selected on the Sensor Selection screen Sensor Confirmation Reselect NON Temp 01 Cancel EN Temp 03 NN Temp 04 Run Calibration Run Verification Main Menu Figure 47 Sensor Confirmation Screen 6 Ifthe sensors you selected are not the ones you want to calibrate press Reselect and repeat steps 5 and 6
144. ts e Select the COM port from the COM Port list box Enter the Company Name e Specify the data directory which will be the default location for storing and retrieving data files and storing the password database Navigate to the location on the network you identified to store the data files This folder should be protected against file deletion 9 Select the desired options and click OK Kaye Validator User s Manual 53 Chapter 3 Installing the Software and Creating User Accounts 3 3 1c Completing Installation 10 Click Finish to complete the initialization program 11 Return to the Windows task bar Click Programs then Kaye Validator and then Client Setup shown in Figure 27 below ce Site Defaults G4 Client Setup Readme EP Kaye Validator HELP Figure 27 Client Setup Program in Kaye Validator Menu 12 Follow the on screen instructions to complete the installation to the first PC Note Once you have installed Kaye Validator to the first PC and set up user accounts as shown on page 59 you can return to the network initialization folder You can then run Client Setup to install Kaye Validator from the network to other PCs 54 Kaye Validator User s Manual Chapter 3 Installing the Software and Creating User Accounts 3 3 2 Installation for a Local Application 1 Insert the Validator CD into your CD ROM drive 2 If the installation does not automatically begin complete the following steps
145. ur PC On the drive identify or create a network location folder to hold the Validator installation and data files This location will also provide a central database for managing user names and passwords The folder should be protected against data deletion Insert the Validator CD into your CD ROM drive If the installation does not automatically begin complete the following steps e Click Start on the Windows task bar and then click Run e Click Browse From the Browse dialog box select your CD ROM drive click Setup exe and then click Open Follow the on screen instructions to perform the installation Click on the appropriate installation path to install Kaye Validator to the network drive Once installation has completed the Kaye Validator Initialization program will run automatically The Kaye Validator splash screen will appear followed by the System Administrator Site Options screen as shown in Figure 3 1 on the next page When you start up the program for the first time you will first set up the System Administrator Site Options Afterwards you will log in using the default System Administrator account and then create your own System Administrator account Kaye Validator User s Manual 49 Chapter 3 Installing the Software and Creating User Accounts 3 3 1 Installation for a Network Application cont System Administration Site Options Policies Preferences Passwords 15 E Allow time
146. ure 57 below displays Sensors are displayed by group The group number is displayed in reverse video Sensor Definitions 1 01 TC TP c Temp 01 89 90 89 90 129 90 130 00 G2 1 02 TC TP G3 Temp 02 90 21 121 31 G4 Review Menu Figure 57 Sensor Definitions Screen For each group the Sensor Definitions screen displays the SIM number and position the sensor type and the sensor label For thermocouple sensors the temperature units and the calibration values are displayed The value on the upper left is the low setpoint reading and the value on the upper right is the low setpoint calibrated value The value on the lower left is the high setpoint reading and the value on the lower right is the high setpoint calibrated value Uncalibrated sensors are marked UNCAL D Failed sensors are marked FAILED For non thermocouple sensors the scaling factors defined in the setup are displayed 92 Kaye Validator User s Manual Chapter 5 The Qualification Study Chapter 5 The Qualification Study 5 1 Introduction Once you have defined a setup you can load it into the Validator from your PC or from a USB flash or floppy disk and then run a standalone or PC controlled qualification study We recommend that you calibrate your sensors to a NIST traceable temperature standard before running your qualification study IMPORTANT The Validator is designed to run either as a standalone instrument or PC controlled When running qualifica
147. uts Real Time screen press the right arrow key on the Validator keypad The Lethality Calculations Real Time screen displays as shown in Figure 63 on the next page Kaye Validator User s Manual 105 Chapter 5 The Qualification Study 5 2 2 Viewing Real Time Calculations and Events cont Group Distribution Time Wed 14 41 05 Min Loc l 01 Min ALeth 0 02 1 01 1 02 1 03 1 04 1 05 1 06 Lethality Calculations Real Time TEMP 90 11C 90 12C Temp 03 Temp 04 Temp 05 Temp 06 Veo ILETH 0 001 0 001 0 001 0 001 0 001 0 001 QUAL 1 ALETH 0 02 0 02 0 02 0 02 0 02 0 02 G2 G3 G4 Main Menu Figure 63 Lethality Calculations Real Time The Lethality Calculations Real Time screen displays real time temperature readings TEMP instantaneous lethality ILETH and accumulated lethality ALETH for the selected group by SIM number and sensor location number The location of the minimum lethality for the selected group and the minimum lethality reading are also displayed Note Jf the lethality calculation has not been defined for the selected group or the lethality calculation has not yet started dashes display in all lethality fields 2 Press the right arrow key 106 Kaye Validator User s Manual Chapter 5 The Qualification Study 5 2 2 Viewing Real Time Calculations and Events cont The Event Messages screen displays as shown in Figure 64 below
148. vice in positioning the sensors To install the IRTD into the CTR 80 Insert the IRTD into one of the two 12 inch nylon spacers An IRTD with the standard 18 inch stem fits properly If you have an older model IRTD with a 15 inch stem shorten the length of the nylon spacers accordingly 32 Kaye Validator User s Manual Chapter 2 The Validator Hardware 2 6 Connecting the System All system connections are on the back of the Validator Make sure the unit is powered off before connecting the IRTD temperature reference LTR 25 140 LTR 40 140 HTR 400 CTR 80 or CTR 40 and SIMs To connect your Validator complete the following steps 1 Connect the IRTD to one of the RJ11 sockets using the M2810 cable supplied with the IRTD Connect the temperature reference to one of the RJ11 sockets using the W1885 1 cable supplied with the temperature reference Insert the wired SIMs into their associated slot positions Insert the thermocouple sensors into the temperature reference See the previous section Sensor and IRTD Installation for installation instructions Connect your PC to the serial or USB port using the cables provided Optional Connect a parallel printer to the 25 pin port The Validator supports the Epson LX 300 printer Use a standard Centronics printer cable to connect the printer to the Validator Connect the temperature reference power cable and the Validator power cable to a grounded power
149. wise the System Administrator is responsible for changing preferences Creates or modifies a setup Changes the setup stored in the Validator Calibrates sensors or verifies sensor calibration Manually stops sensor calibration or calibration verification Manually starts or stops a qualification study or exposure cycle IMPORTANT 4 user account is not active until users change their temporary password 7 when they log in to the PC program for the first time Users will be unable to run the Validator in standalone mode if they have not changed their temporary password Set default user permission for this new account to Supervisor or Operator by clicking the associated button Kaye Validator User s Manual 61 Chapter 3 Installing the Software and Creating User Accounts 3 5 Creating User Accounts cont 8 The Disable User Account option allows you to deny access to the system for this user For example if you are creating an account for a user who will not need access to the system for several months you may want to select this option to deny access to the user You can de select this feature once the user is ready to use the system see the Validator online Help for instructions on editing user accounts Click any specific Permissions you wish to grant the user While Operators or Supervisors have certain standard permissions you can modify a specific account so that the user can Create setups Execute qualificati

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M4350E, rev. C.book - GE Measurement & Control