Kaye Validator - SiSW

1 Validation Kaye Validator . User's Manual Amphenol M4350E Rev. K. July 2014. Advanced Sensors Kaye Validator . Thermal Process Validation System User's Manual M4350E Rev. K. July 2014. Amphenol Copyright 2014 Amphenol Thermometrics, Inc. 967 Windfall Road St. Marys, PA 15857-3333, USA. Advanced Sensors Web: [No content intended for this page]. Contents Chapter 1. The Kaye Validator Introduction ..1. Validator Benefits ..2. About this Manual ..3. The Kaye Validator System ..4. The Validator Hardware ..4. Sensor Input Modules (SIMs) ..5. Plug-In Hardware Connections ..6. The Validator Software ..7. User Access ..7. User Identification.

2 8. Electronic Data Requirements ..9. The Study Setup ..10. Sensor Calibration .. 11. The Qualification Study ..12. Using the Validator System ..13. Chapter 2. The Validator Hardware Introduction ..15. The Validator Instrument ..16. Display Screen and Control Keys ..16. Connection Ports ..18. Symbol Identification ..20. Internal Memory..21. Backup Battery ..22. Sensor Input Modules ..24. Wiring SIMs ..25. Kaye IRTD..30. Temperature Reference ..31. Sensor and IRTD Installation ..32. Connecting the System ..34. Setting the Validator Time and Date ..35. Kaye Validator User's Manual iii Contents Setting the Display Screen Contrast.

3 35. Viewing Calibration Information .. 39. Return to the Main Menu .. 45. Preventive Maintenance.. 46. Fuse Replacement .. 46. Calibration .. 46. Display Cleaning.. 46. Transporting and Shipping .. 47. Chapter 3. Installing the Software and Creating User Accounts Introduction .. 49. PC Requirements .. 50. Installing Kaye Validator .. 50. Installation for a Network Application .. 51. Installation for a Local Application .. 57. Starting Kaye Validator .. 58. Creating Your System Administrator Account .. 59. Creating User Accounts .. 61. Printing the User List .. 65. Standalone Passwords .. 66. Selecting a Communications Port.

4 68. Getting Help.. 71. Uninstalling the Software .. 71. Chapter 4. Calibrating Sensors Introduction .. 73. Preliminary Steps .. 74. iv Kaye Validator User's Manual Contents Performing a Standalone Calibration ..75. Selecting the Disk Storage ..76. Loading a Setup ..78. Selecting Sensors ..83. Calibrating Sensors ..86. Rewrite Report to Disk..90. Viewing Calibration Offsets ..93. Chapter 5. The Qualification Study Introduction ..97. Performing a Standalone Qualification Study..99. Loading a Setup ..100. Starting the Qualification Study ..105. Viewing Real-Time Sensor Readings, Calculations, and Events ..107. Viewing Historical Sensor Readings, Calculations, and Events.

5 118. Reviewing Setup Data .. 119. Starting and Stopping the Exposure Cycle..122. Ending the Qualification Study ..125. Rewrite Report to Disk..128. Pausing Data Recording During the Qualification Study ..131. Chapter 6. Calibration Verification Introduction ..135. Performing a Standalone Calibration Verification ..137. Loading a Setup ..137. Selecting Sensors ..142. Verifying Sensor Calibration ..145. Rewrite Report to Disk..149. Chapter 7. Specifications Total System Specifications..153. Analog Input ..154. Sensitivity ..154. Kaye Validator User's Manual v Contents Thermocouples.. 154. Voltage Temp Coefficient.. 154. Scanning Speed.

6 154. Input Impedance.. 154. Compensator Temperature Coefficient .. 154. Common Mode Rejection .. 154. Input Terminal Temperature Non-Uniformity .. 155. Input Ranges .. 155. Max. Common Mode Voltage .. 155. Environmental Temperature.. 155. Relative Humidity .. 155. Normal Mode Rejection.. 155. Physical Specifications .. 156. Power .. 156. Fuse Rating .. 156. Voltage Input Resolution.. 156. Size (H x W x D) .. 156. Voltage Input .. 156. Weight .. 156. Accuracy .. 156. Real Time Clock Accuracy .. 156. Appendix A. Environmental Compliance Waste Electrical and Electronic Equipment (WEEE) Directive .. 157. Battery Disposal.. 158. What do the Markings Mean?

7 158. The Risks and Your Role in Reducing Them .. 159. vi Kaye Validator User's Manual Chapter 1. The Kaye Validator Chapter 1. The Kaye Validator 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 Kaye'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.

8 A complete Kaye Validator validation system includes: The Validator instrument The Validator software for Windows 7 and XP. A notebook or desktop PC (minimum Pentium 300 MHz with at least 256 MB RAM and Microsoft Office 2007, 2010 (32-bit only) or 2013, and a printer that supports both portrait and landscape page orientation Up to three Kaye Sensor Input Modules (SIMs). A Kaye high temperature reference (HTR 400), a Kaye low temperature reference (LTR-90, LTR -25/140 or LTR -45/140), or a Kaye cold temperature reference (CTR-80 or CTR-40). A Kaye Intelligent RTD probe (IRTD). Premium grade thermocouples Additional temperature and non-temperature sensors for qualification studies (optional).)

9 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 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 (only in units built before July 2011) 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.

10 Or qualify 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. 2 Kaye Validator User's Manual Chapter 1. The Kaye Validator 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.