Amphenol Thermometrics AVS-X2015 Advanced validation system User Manual Kaye Validator AVS User s Manual

Amphenol Thermometrics, Inc. Advanced validation system Kaye Validator AVS User s Manual

User manual

Validation Kaye Validator ® AVS User’s Manual M5100-EN Rev. D October 2016 Amphenol Advanced Sensors
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Kaye Validator ® AVS Thermal Process Validation System User’s Manual M5100-EN Rev. D October 2016 Copyright © 2016 Amphenol Thermometrics, Inc. 967 Windfall Road St. Marys, PA 15857-3333, USA Web: www.amphenol-sensors.com. Amphenol Advanced Sensors
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Contents Kaye Validator AVS User’s Manual i Chapter 1. The Kaye Validator AVS .............................................................. 1 1.1 Introduction .................................................................................................... 1 1.2 Validator AVS Benefits ................................................................................. 3 1.3 About this Manual ......................................................................................... 5 1.4 The Kaye Validator AVS System ................................................................ 6 1.4.1 The Validator AVS Hardware .............................................................. 6 1.4.2 Sensor Input Modules (SIMs) .............................................................. 7 1.4.3 Plug-In Hardware Connections ........................................................... 8 1.5 The Validator AVS Software ........................................................................ 9 1.5.1 User Access ........................................................................................... 9 1.5.2 User Identification ................................................................................. 9 1.5.3 Electronic Data Requirements .......................................................... 10 1.5.4 The Study Setup.................................................................................. 10 1.5.5 Sensor Calibration .............................................................................. 11 1.5.6 The Qualification Study ...................................................................... 12 1.6 Using the Validator AVS System .............................................................. 13 Chapter 2. The Validator AVS Hardware .................................................... 15 2.1 Introduction .................................................................................................. 15 2.2 The Validator AVS Instrument .................................................................. 16 2.2.1 Connection Ports ................................................................................. 16
Contents Kaye Validator AVS User’s Manual ii 2.2.2 Symbol Identification .......................................................................... 17 2.2.3 Side Port for Data Transfer ................................................................ 18 2.2.4 The Console ......................................................................................... 19 2.2.5 Internal Memory .................................................................................. 20 2.2.6 Backup Battery .................................................................................... 21 2.3 Sensor Input Modules ................................................................................ 22 2.3.1 Wiring SIMs ............................................................................................ 23 2.4 Kaye IRTD .................................................................................................... 31 2.5 Temperature Reference ............................................................................. 32 2.5.1 Sensor and IRTD Installation ............................................................ 33 2.6 Connecting the System .............................................................................. 35 2.7 Setting the Validator AVS Time and Date ............................................... 36 2.8 Preventive Maintenance ........................................................................... 36 2.8.1 Fuse Replacement .............................................................................. 36 2.8.2 Calibration ............................................................................................ 36 2.9 Transporting and Shipping ........................................................................ 37 Chapter 3. Creating User Accounts ............................................................ 38 3.2.1 Creating New System Administrator Accounts ............................... 41 3.3 Creating New User Accounts .................................................................... 43 3.4 Setting Preferences .................................................................................... 46 3.5 Setting Policies ............................................................................................ 48 3.6 Updating the Kaye Validator AVS Firmware ........................................... 49
Contents Kaye Validator AVS User’s Manual iii 3.7 Handling Data Files .................................................................................... 50 3.8 Online Help .................................................................................................. 53 Chapter 4. Defining Equipment ................................................................... 54 4.1 Adding New Equipment.............................................................................. 55 4.2 Checking Details for Existing Equipment ................................................ 56 4.3 The Calibration reminder ........................................................................... 57 Chapter 5. Defining Assets .......................................................................... 58 5.1 The Asset Details Screen .......................................................................... 59 5.2 The New Asset Screen .............................................................................. 61 Chapter 6. Defining Study Setups .............................................................. 63 6.1 Create a Setup File ..................................................................................... 64 6.2 Modify an Existing Setup ........................................................................... 64 6.3 The Define Setup Screen .......................................................................... 65 6.4 The Sensors Configuration Screen .......................................................... 66 6.5 Understanding Groups ............................................................................... 69 6.6 Assigning Sensors to Groups .................................................................... 70 6.7 Specifying Group Calculations .................................................................. 72 6.8 Specifying Calibration Parameters ........................................................... 73 6.9 Specifying Qualification Study Conditions ............................................. 75 6.10 Reviewing and Changing the Setup ........................................................ 76 Chapter 7. Calibrating and Verifying Sensors ........................................... 77 7.1 Introduction .................................................................................................. 77
Contents Kaye Validator AVS User’s Manual iv 7.2 Loading a Setup into the Validator AVS .................................................. 79 7.3 Selecting Sensors ....................................................................................... 80 7.4 Calibrating or Verifying Sensors ................................................................ 81 7.4.1 Automatic, Semi-Automatic or Manual Mode .................................. 82 7.4.2 Calculate Stability ................................................................................ 82 7.4.3 Calculate Deviation of Uncalibrated Sensors .................................. 83 7.4.4 Calculate Deviation of Calibrated Sensors ...................................... 83 7.4.5 Data Logging Complete at Setpoint .................................................. 83 7.4.6 The Graph View ................................................................................... 84 7.5 Current Calibration and Hardware Connections ..................................... 84 7.5.1 Reasons for Calibration Failure ......................................................... 85 Chapter 8. Viewing Live Data ....................................................................... 86 8.1 Select Validator AVS .................................................................................. 86 8.2 Monitoring Live Data ................................................................................... 88 8.3 Check Communications Connections ...................................................... 93 8.4 Select a Temperature Standard ................................................................. 93 Chapter 9. The Qualification Study ............................................................. 94 9.1 Introduction .................................................................................................. 94 9.2 Load a Setup ................................................................................................ 96 9.2.1 Select a Setup File .............................................................................. 96 9.3 Viewing the Active Qualification Study ..................................................... 98 9.4 Graph Real-Time Sensor Readings and Calculations ......................... 100
Contents Kaye Validator AVS User’s Manual v Chapter 10. Generating Reports ................................................................... 102 10.1 Reports Overview ...................................................................................... 102 10.2 Report Types .............................................................................................. 103 10.2.1 Setup Report ...................................................................................... 103 10.2.2 Calibration Report ............................................................................. 104 10.2.3 Qualification Reports ......................................................................... 104 10.2.4 Calibration Verification Report ............................................................ 106 10.2.5 Audit Trail ............................................................................................ 107 10.3 The Reports Hub ....................................................................................... 111 10.4 The Report Analysis Screen .................................................................... 112 10.5 The Reports Details Screen ..................................................................... 113 10.6 The Performance Analysis Screen ......................................................... 116 10.7 The Standard Reporting Screen ............................................................. 119 10.8 The Report Template Screen .................................................................. 119 10.9 The Add Cycles Screen ............................................................................ 120 10.10 The Report Screen ................................................................................ 124 10.11 The Graph Report Screen ................................................................... 125 10.12 The Customize Calculations Screen ................................................. 128 10.13 The Customize Groups Screen ............................................................ 129 10.14 Report Options Screen.......................................................................... 130 Appendix A. Understanding Audit Trail Events ......................................... 132 Appendix B. Environmental Compliance ..................................................... 142
Contents Kaye Validator AVS User’s Manual vi B.2 Battery Disposal ........................................................................................ 144 B.2.1 What do the Markings Mean? .......................................................... 144 B.2.2 The Risks and Your Role in Reducing Them ................................ 145 B.2.3. System Specifications ................................................................................ 146 B.3 FCC Part 15 details .................................................................................. 147 Appendix C. Safety and Precautions ........................................................... 148 Appendix D. Service information ................................................................. 150
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 1 Chapter 1. The Kaye Validator AVS 1.1 Introduction Figure 1: The Kaye Validator AVS The Kaye Validator® AVS system is a validation system designed for thermal process validation in the pharmaceutical and biotechnology industries. It features automated sensor calibration and qualification reporting. A complete Kaye validation package, which lets you perform a fully automated sensor calibration, includes:  One or more Kaye Validator AVS  One or more Kaye Validation Consoles for programming and control
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 2  Up to four Kaye Sensor Input Modules (SIMs) per Validator (each SIM supplies up to 12 thermocouple sensors)  A Kaye high temperature reference (HTR 400), a Kaye low temperature reference (LTR –90, LTR –25/140 or LTR –40/140), or a Kaye cold temperature reference (CTR –40 or CTR –80) for sensor calibration and verification  A Kaye Intelligent RTD probe (IRTD)  Premium grade thermocouples  Additional temperature and non-temperature sensors for qualification studies (optional) Users can select, and log in to, any Kaye Validation Console to communicate with any Validator AVS, monitoring current studies and calibrations. Using the synchronization all Assets, Studies, and Qualification data are visible across all Consoles. While a Console can log in to one Validator at a time, multiple Consoles can log in to the same Validator AVS. Users can disconnect a Console after initiating a study or qualification; also, any user with any Console can stop a calibration or study currently running on any Validator AVS. Both Consoles and Validator AVS’ can be on a user's local network, and users can obtain software upgrades for the Consoles.
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 3 1.2 Validator AVS Benefits A Kaye Validator AVS system consists of the Validator AVS and the Validation Console. The console can be docked directly to the Validator AVS and is used as the operator interface to the Validator AVS. Selectable input capacity (1 to 4 SIMs) up to 48 total inputs. Robust Design • Robust industrial design with two handles • IPL55 rating, chemical resistant ABS housing • Dedicated Validation Console for improved user interface • On-board docking station for Kaye Validation Console • Battery backup with field replaceable battery pack (max 3 hours) Data Security via Smart Redundancy Concept • Standalone operation of Validator AVS – console connection not needed • Validator AVS Internal Memory • Second independent mirrored memory card for data redundancy • Data download to validation console • Forced download of study and audit data to USB • Backup and restore – synchronization of console data with server and other consoles. Hardware Connectivity The Kaye Validator AVS comes complete with improved robust connections for IRTD and Calibration Baths. The Validator AVS is backward compatible with all existing IRTD and Kaye Baths for Automatic Calibration. Two relay outputs are also available to be activated via Qualification events.
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 4 Sensor Inputs • Up to 4 SIMS: 48 channel capacity • Scan speed of 36 channels per second / 48 channels 2 seconds • SIMs for TCs, 4-20mA, 0-10V and RTDs • Improved Sensor Connectivity (quick-fix & lock connectors) • Accepts a wide range of thermocouple types (T, T premium, J, K, E, B, R, N, S)
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 5 1.3 About this Manual The first part of this manual provides an overview of the Validator AVS hardware, instructions for creating user accounts and entering asset and equipment information, and an overview on using the Validator AVS software. The second part of this manual covers using the Validator AVS, including calibrating sensors, running qualification studies, and verifying sensor calibration. The following is a brief description of each section of this user's guide:  Chapter 1 provides an overview of the Validator AVS system.  Chapter 2 explains the Validator AVS hardware and provides instructions for connecting the system.  Chapter 3 provides instructions for creating user accounts.  Chapter 4 provides instructions for entering Kaye equipment into the system.  Chapter 5 provides instructions for entering assets into the system.  Chapter 6 provides instructions for creating setups.  Chapter 7 provides instructions for performing calibration or verification.  Chapter 8 provides instructions for displaying live data on the Console.  Chapter 9 provides instructions for performing a qualification study.  Chapter 10 provides instructions for creating reports.
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 6 1.4 The Kaye Validator AVS System The Kaye Validator AVS 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 AVS Hardware The Validator AVS is a self-contained instrument, incorporating high-accuracy sensor measurement hardware with secure data recording capability. It accepts programming and control from one or more Kaye Validation Consoles. The Validator AVS provides standalone functionality when calibrating sensors and running qualification studies. Figure 2: The Validator AVS System The Validator AVS accepts up to 48 inputs in any combination of thermocouple, voltage or current inputs or 24 RTD inputs. The instrument is equipped with an universal power supply (100-240 VAC) and connections for two Kaye temperature references (although only one standard can be used at any given time), one Kaye temperature standard, and two contact output for signaling a PLC or other devices.
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 7 1.4.2 Sensor Input Modules (SIMs) The Validator AVS uses Sensor Input Modules to provide secure connection of sensors to the Validator AVS 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 3: Sensor Input Module The Validator AVS can be configured for up to 4 SIMs. Each SIM has: • Sensor inputs: TC-SIMs have 12 sensor input connections, RTD SIMs can connect 6 RTD sensors, 4-20mA SIMs can connect 12 sensors and one connection for an external power supply • A memory chip to store calibration offsets, SIM serial number, slot location, and the serial number of the Validator AVS measurement board where calibration was performed • A cold junction reference RTD to maintain measurement accuracy in different environmental conditions Using 4 SIMs, you can attach up to 48 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.
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 8 1.4.3 Plug-In Hardware Connections The Validator AVS has connectors on the back of the unit for easy plug-in of SIMs, temperature standards, temperature references. It also provides connection ports for USB and Ethernet for the Console and the Validator. Another separate USB port is utilized for the year device calibration USB with the ICAL software. The USB memory card port on the left side of the instrument can be used to dump the saved studies from the AVS directly to a thumb drive. An icon indicating the type of device identifies each connector. Figure 4: Validator AVS Connections For a more complete description of the hardware, see Chapter 2, The Validator AVS Hardware.
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 9 1.5 The Validator AVS Software The Validator AVS software provides everything you need to perform validation testing. Using the Validator AVS software, you: • Create user accounts and assign user IDs, passwords and permission levels. • Create validation study setups that run on the Validator. When calibrating sensors and running qualification studies with the Console connected, the Validator AVS 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 to generate reports containing only the results you need to document your study. 1.5.1 User Access You can set user access to the Validator AVS to match the way your company works. The Validator AVS software is designed user level has specific permissions that define system access. Permissions can also be customized for each user. 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 AVS user. Each user ID is associated with a unique user name to provide traceability during the validation process. The Validator AVS requires users to enter their user ID and password whenever they: • Create, modify, or move a setup • Change the setup stored in the Validator AVS • Calibrate sensors or verify sensor calibration • Manually start or stop a qualification study • 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 audit file along with a description of the action.
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 10 1.5.3 Electronic Data Requirements The Validator AVS is designed to help you meet the guidelines for electronic signatures as specified in FDA Regulation 21 CFR part 11, Electronic Records; Electronic Signatures. • Two levels of identification - user ID and password • 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 • Electronic signature identifies the user, and includes the date and time of the action • Data files are encrypted and can only accessed through the AVS software. If the data is tampered with, the entire data file becomes inaccessible • Password expiration feature allows you to set a password expiration • System Administrators can set a minimum-password length requirement • 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 AVS program and the Validator AVS 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. 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  Assign sensors to groups and specify group calculations  Define group events to be monitored during the qualification study
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 11  Specify calibration setpoints, temperature stability, and deviation criteria for sensor calibration and verification  Specify start and stop conditions for the qualification cycle and the exposure cycle  Specify how often to scan sensors  Define the output relays After you have created and saved your setup, you run the study by loading the setup into the Validator AVS via connection from your Console to the Validator AVS. See the Validator AVS online Help for instructions on setting up a study. 1.5.5 Sensor Calibration The Validator AVS 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 two-point calibration, or a two-point calibration with an additional check-point. Sensors that do not meet the pre-qualification calibration test criteria are marked as failed and are not calibrated. Sensors that fail calibration are marked red in the live data screens and 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 required criteria. You can perform a one-point, two-point or three-point post-qualification verification or even change the criteria before running the 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. 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. For instructions on sensor calibration, see Chapter 7, Calibrating and Verifying Sensors.
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 12 1.5.6 The Qualification Study During a qualification study, the Validator AVS performs calculations and compiles data for your reports. For details how to run the qualification study using the Validator AVS software, see Chapter 9, The Qualification Study and the Validator AVS online Help. 1.5.6a 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 Validator AVS 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 AVS software. You can create four different report types: • Setup Report • Calibration Report • Qualification Report • Calibration Verification Report Each report is traceable to the original study data. 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 AVS online Help.
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 13 1.6 Using the Validator AVS System The Validator AVS system allows you the flexibility to design your qualification procedures to fit your workplace requirements. To perform a typical qualification study, it is recommended to follow the following steps in order: 1. Use the Validator AVS software to define an Asset An asset is the equipment that is validated in its specifications. This could be an autoclave, a freezer, an incubator or any other device that validated. It is entered into the AVS software with all relevant data including serial number, validation frequency, manufacturer and even pictures and wiring diagrams. 2. Use the Validator AVS software to create a setup. A setup defines the type of sensors and the validation parameters specific to your asset. If you have pre-wired SIMs, assign your sensor locations according to the SIM configuration. 3. Generate the Setup Report. Use the Setup Report to verify your validation parameters and as a reference for connecting your sensors. 4. If you do not have pre-wired sensors, wire your thermocouples and auxiliary sensors to the SIMs as based on the Setup Report. 5. Connect the hardware and confirm connections. Once the hardware is connected, use the Validator AVS software to display a graphical representation of your validation equipment to verify hardware and communications connections. 6. Load the setup into the Validator AVS to calibrate sensors and run your study. IMPORTANT: During sensor calibration and the qualification study, you can use the Console to view data and track your progress. 7. With your hardware configured for the validation study: • Calibrate sensors against the temperature standard • Run the qualification study • Run post-qualification calibration verification
Chapter 1. The Kaye Validator AVS Kaye Validator AVS User’s Manual 14 1.6 Using the Validator AVS System (cont.) The Validator AVS collects all study data and stores it in a secure data file internally. When the study is finished the data is downloaded into your Console’s memory. 8. With the secure data file loaded on your Console, use the Validator AVS software to design and generate reports to document the specifics of your study. • Reporting Tool, a reporting utility that enables you to create setup, calibration, calibration verification and qualification reports, and to export qualification data to a CSV file. With Reporting Tool, you can edit the groups and sensors that appear in a qualification report, select cycles and add comments. For qualification reports, enhanced graphing capabilities allow selecting and removing sensors, constants and calculations. • You can access and print out the Audit Trail
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 15 Chapter 2. The Validator AVS Hardware 2.1 Introduction The Kaye Validator AVS comes equipped with a universal power supply, a power cord for 115 VAC (or 230 VAC as necessary), over 4 GB of internal memory, and a USB flash drive interface. This chapter describes the Validator hardware and provides instructions for connecting the system. Included are sections describing: • The back of the Validator AVS instrument has connection ports for all system devices and a USB flash drive interface on the left side. • Internal memory • Backup battery • Sensor Input Modules (SIMs), which are used to connect sensors to the Validator AVS • The Kaye temperature reference, which provides the stable temperature required for sensor calibration • The Kaye IRTD, a self-contained temperature standard • Connecting the system • Setting the Validator AVS time and date • Viewing calibration information • Preventive maintenance • Transporting and shipping
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 16 2.2 The Validator AVS Instrument The Validator AVS instrument is equipped with over 4 GB of internal memory, and a backup battery in case the system loses AC power. 2.2.1 Connection Ports The back of the Validator AVS (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. Below the ports are the ON/OFF switch and the AC power input. Figure 5: Connection Ports
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 17 2.2.1 Connection Ports (cont.) Table 1: Connection Port Explanations Icon Connection Port 4 Pin Din Connector There are three 4-pin Din connectors, labeled with a temperature reference icon, for connecting IRTDs and one Kaye temperature reference. (Note: The Validator AVS can accept data from only one IRTD at any given time. For calibrations only the upper port is active!) Output Relay There are two NO/NC relay outputs, labeled with a contact switch icon, for signaling a PLC or other device. Relay Rating: 110 VAC ½ amp resistive load 24 VDC 2 amps resistive load 110 VAC ¼ amp inductive load 24 VDC 1 amp inductive load USB Connector One USB connector, labeled with a USB icon, is available for connecting an ICAL device. ICAL port is used for Service only USB/ Ethernet Connector There are two USB/Ethernet communications ports for connecting the Validator AVS and the Console. Ethernet cable to be less than 3 meters long 2.2.2 Symbol Identification Protective Earth Terminal Caution (Refer to accompanying documentation.)
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 18 2.2.3 Side Port for Data Transfer On its left side, the Validator AVS offers a side port with a USB port (to accommodate a USB flash drive) and a button for data transfer, as shown in Figure below. The Validator AVS writes the study data into the internal memory. If there is an unread study available on the Validator AVS there is a message when connecting the console and the study data is transferred to the console directly. Alternatively the study data can be dumped to the USB side port. After connecting an USB flash drive and pressing the button the last 10 studies are written to the Flash drive and can be reimported into the console through the AVS software. To provide data security, data is stored in secure data files that can only be read by the Validator AVS software. Files that have been tampered with are no longer readable by the software. This port is used only for data dump and not for connecting console. Use the AVS convert function (see chapter 3.7) to import the files into the Validation console. Figure 6: Side Port for Data Transfer
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 19 2.2.4 The Console For programming and control, each Validator AVS includes a Microsoft Industrial Embedded OS based Console Figure below shows the procedure for docking a Console to a Validator AVS via its docking station. Figure 7: Docking and Releasing Console
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 20 2.2.5 Internal Memory The Validator AVS is designed to write data to internal memory during sensor calibration and qualification studies. Qualification data resides in internal memory until it is read out to a console. Up to 10 studies are stored in the internal drive. The Validator AVS provides over 4 GB of internal memory to maintain qualification data during a study. The final study data is stored in the internal 32GB solid state memory. The 32GB solid state memory is mirrored to a 32GB SD-card memory that can get extracted by a Kaye technician for emergency recovery. The Validator AVS allows you to scan data at 12 inputs per second per SIM slot during the qualification study. If SIM slot 4 is used the storage rate is reduced to 2 seconds allowing the maximum of 36 inputs per second or 48 inputs every 2 seconds. Compared to the Kaye Validator 2000 there is no fast scan or slow scan available anymore.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 21 2.2.6 Backup Battery The Validator AVS is equipped with a lithium ion backup battery to provide short-term power in case of AC power loss. The intent of the battery is to provide sufficient time (approximately 3 hours) so that you can perform an orderly shutdown of the system. When the Validator AVS detects that the AC power has failed and the system is running from battery, the power icon on the front panel changes from green to red while the battery LED show the current battery state. Valid battery states are: - Solid Green = more than 75%, - Solid Yellow = less than 75%, - Blinking red = battery capacity is near end and device will shut down within the next 15 Minutes, - Solid red = battery defect). - Blinking green = AC Power is connected and battery is charging While running on battery power the AVS beeps every 10 Minutes. IMPORTANT: In the event of power glitches or short-term drops in supply voltage (“brownouts”), there is a remote chance that the Validator AVS will fail to fall back to its backup battery. In this case the Validator AVS will reset and potentially lose any study data stored in internal memory. To prevent this from occurring, it is recommended that you connect the Validator AVS 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. Remove battery from the battery pack before servicing the instrument. The Validator AVS monitors its own battery voltage. When the battery has approximately six minutes of power remaining, the Validator AVS stops collecting data and closes its data files. The unit is equipped with rechargeable, field replaceable, battery pack. A replacement battery pack is available (Type RRC2040-2, Kaye Art. Nr 200-163). CAUTION! Batteries must be disposed of in accordance with local, state and federal regulations.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 22 2.3 Sensor Input Modules The Validator AVS plug-in Sensor Input Modules (SIMs) help reduce the time it takes to perform validation studies. Each SIM has: • 12 sensor input connections, 6 for RTD SIMs • A memory chip to store calibration offsets, SIM serial number, slot location, and the serial number of the Validator AVS measurement board where calibration was performed • A cold junction reference RTD to help maintain measurement accuracy through changing environmental conditions Each TC SIM accepts T, J, B, S, R, N and K type thermocouples as well as inputs up to 10 VDC. Using 4 SIMs, you can attach up to 48 inputs in any combination of thermocouples, contact or voltage inputs. For 4 to 10mA current inputs a separate SIM is available. SIMs are designed 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, it is recommended that you use the supplied erasable labels to record: • SIM serial number • SIM slot number • Serial number of the Validator AVS 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 AVS. Make sure all SIMs are connected prior to powering up the Validator AVS, or you will have to power down, insert your SIMs, and power up again. If a SIM is disconnected after power up, calibrated offsets or SIM data might not be read correctly. To rectify this, power down, reconnect the SIM, and power back up.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 23 1 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. It is recommended 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 8 below shows the inside of a SIM. Figure 8: SIM Wiring Components: • Tie wrap mounts • Connector (locations 1 - 6) • Sensing RTD • Connector (locations 7 - 12) • Sensor location number. There are 12 connection locations, labeled 1 - 12, with a positive and negative connector for each input. 2. Press the two press-keys to open connectors where the sensor is to be inserted.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 24 3. Connect your inputs. Valid inputs are: • Thermocouples T, J, B, S, R, N and K (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. Release the two keys. 5. Repeat Steps 2 through 4 for remaining sensors. 6. 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 9 below to maintain the thermal accuracy of the module. Figure 9: SIM Wiring Legend: 1 = Tie wraps (provided) 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 AVS 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.”
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 25 2.3.1a Connecting a Thermocouple Connect types J, K and T thermocouples to the connectors as shown in Figure 10 below. Cut through the outer insulation to separate the red and blue wires, and then strip back each wire approximately ½ inch in order to make the connection with the connector. + – + – + – + – + – + – 1 2 3 4 5 6 Figure 10: 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 11 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 11 below). Figure 11: Drip Cut
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 27 2.3.1a Connecting a Thermocouple (cont.) Also, it is recommended to shave 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 12 below. Figure 12: 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.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 28 2.3.1b Connecting a Contact You can connect dry contact inputs directly to the TC-SIM, as shown in Figure 13 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. + – + – + – + – + – + – 1 2 3 4 5 6 Figure 13: 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 14 below. Always connect the positive (+) lead to the positive (+) connector and the negative (-) lead to the negative (-) connector. + – + – + – + – + – + – 1 2 3 4 5 6 Voltage + Transducer – Figure 14: Voltage Input Connection
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 29 2.3.1d Connecting a Current Transmitter A dedicated 4-20 mA SIM 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 TC-SIM. Connect a precision shunt resistor to the connectors to convert the current to a measurable voltage, as shown in Figure 15 below. A 250  resistor converts a 4-20 mA signal to a Voltage signal. The 62.5  resistor converts a 4-20 mA signal to 0.25-1.25V. These voltages can be defined in the TC setup as voltages accordingly. For easier handling we recommend using the dedicated 4-10mA SIMs in the first place. Figure 15: Current Transmitter Connection The 4-20 mA SIM can be configured in two ways based on the power connections. The user can switch between externally powered or locally powered, based on the placement of the jumper blocks as shown in the figures. Please refer to the wording on the SIM itself to show current jumper placement and orientation. Sensors using 4-20 mA outputs can be attached in several different ways: If the sensor requires less than 4mA to operate, • Connect the positive lead to the positive input channel and the negative lead to the negative input channel, as shown in Figure 1 below. • Configure the jumper block for Local Power and attach 24V supply to J4. Figure 16: Configuration for Sensor with less than 4mA Power External Local
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 30 If the sensor requires More Than 4mA, it will normally have a second set of terminals to supply power. • Connect the transmitter output to the input channel (+ to + and - to -), as shown in Figure 2. • Configure the jumper block for External Power. Figure 17: Configuration for Sensor with More than 4 mA Power If the sensor requires less than 4mA to operate and is loop powered remotely, see option 1 or 2 below for connection. Configure jumper block for same channel as External Power. Figure 18: Configuration for Sensor with Less than 4 mA Power (Loop Powered Remotely) The Red LED (on the SIM is powered from the AVS and will be on when the AVS is on and the SIM is plugged in. The Green LED is on if the sensor is powered via the external power source connector. External Local External Local
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 31 2.4 Kaye IRTD The Kaye IRTD temperature measurement standard is a self-contained measurement system providing temperature data directly to the Validator AVS software. The measurement accuracy is traceable to the national standard to 0.025ºC, with a range of -196ºC to 420ºC. The IRTD provides a traceable standard that is used to correct the temperature readings of your thermocouples. During the calibration process, the Validator AVS 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 AVS 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 AVS also reports a communications error if an IRTD is disconnected from the unit during sensor calibration or a qualification study.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 32 2.5 Temperature Reference Temperature references provide the stable temperature required for sensor calibration. Six temperature reference models are available. They are designed to provide different temperature ranges and are compatible with the Validator AVS. LTR-90 (setpoint range -95°C to 140°C at 23°C ambient) Recommended for calibration of sensors used in freeze dryers, freezers, cryogenic units, incubators and steam autoclaves. The LTR-90 accepts up to 12 thermocouples 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 30°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.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 33 2.5.1 Sensor and IRTD Installation The Kaye LTR-90, 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 has three thermocouple wells and two 12-inch nylon spacers to allow you to properly position your thermocouples and Kaye IRTDs. LTR-90, LTR -25/140, LTR -40/140, and HTR 400 To insert thermocouple sensors into the LTR-90, LTR -25/140, LTR -40/140, and HTR 400: • For LTR-90, insert the thermocouple sensors through the rubber insulator first. IMPORTANT: The LTR-90 comes with a rubber insulator. This rubber insulator must be used at all times. If it is not used, specifications are not guaranteed. Also, at cold temperatures, there will be significant ice buildup, that will affect accuracy and uniformity. • 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-90, LTR -25/140, LTR -40/140, and HTR 400: • For LTR-90, insert the IRTD through the rubber insulator first. • Insert the IRTD very slowly into one of the two reference wells (the two small wells) in the LTR-90, 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.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 34 2.5.1 Sensor and IRTD Installation (cont.) CTR -80 To insert thermocouple sensors into the CTR -80: • 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 device 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.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 35 2.6 Connecting the System All system connections are on the back of the Validator AVS. Make sure the unit is powered off before connecting the IRTD, temperature reference (LTR-90, LTR -25/140, LTR -40/140, HTR 400, CTR -80, or CTR -40), and SIMs To connect your Validator AVS, complete the following steps: 1. Connect the IRTD to one of the 4 pin Din sockets, using the cable supplied for IRTD. 2. Connect the temperature reference to one of the 4 pin Din sockets, using the cable supplied for temperature reference. 3. Insert the wired SIMs into their associated slot positions. 4. Insert the thermocouple sensors into the temperature reference. See the previous section, Sensor and IRTD Installation, for installation instructions. 5. Connect your Console to the Validator AVS. 6. Connect the temperature reference power cable and the Validator AVS power cable to a grounded power source. 7. Turn the temperature reference power switch to the ON position. 8. Turn the Validator AVS power switch to the ON position. IMPORTANT: SIMs are only recognized by the system properly when you power up the Validator AVS. If a SIM is disconnected after power up and reconnected, offsets and internal SIM data are might not recognized correctly. To rectify this, power down and power back up.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 36 2.7 Setting the Validator AVS Time and Date When the Console starts any kind of study, the current time and date are automatically transferred to the attached Validator AVS. No action on your part is required. Refer to the Windows documentation for instructions for changing the date and time. 2.8 Preventive Maintenance 2.8.1 Fuse Replacement The Validator AVS is equipped with a 250V T 4A 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 4A replacement fuse. 2.8.2 Calibration Each Validator AVS is fully calibrated before shipment. The equipment normally requires no further adjustment or calibration during installation. Under normal operating conditions, it is recommended you calibrate the Validator AVS once a year to maintain peak system accuracy. If you use a Validator AVS for high accuracy measurements, or if circuit boards are replaced or added, you may need to certify the calibration more often.
Chapter 2. The Validator AVS Hardware Kaye Validator AVS User’s Manual 37 2.9 Transporting and Shipping The Validator AVS is designed to be easily transportable from one place to another within a plant. The unit weighs approximately 26.5 pounds (lb) or 12 kg, including the Validation console (without SIMs) and comes with two robust handles for carrying. For shipping the Validator AVS, you need a safe and durable container. A rugged, foam-fitted hard case equipped with wheels and a collapsible handle is delivered together with your Validator AVS. It includes secure space for the Validator AVS, the Console and accessories such as SIMs and cables. We encourage you to use this hard case for transport, storage and shipping of the Validator AVS. If you use another type of container, make sure the Validator AVS is padded on all sides with four inches of cushioning filler. If you need to return the Validator AVS for service, contact the Customer Service Department for a Return Materials Authorization Number before you ship. Include the number with the instrument.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 38 Chapter 3. Creating User Accounts 3.1 Introduction The Kaye Validator AVS software Password Maintenance utility allows a user with System Administrator permission to create and maintain user accounts, set site options, backup and restore user information, and view, print, and maintain the audit trail. All system administration tasks are accomplished through the Password Maintenance utility program and logged in the audit trail. The Kaye Validator AVS software includes a Kaye Default System Administrator account that allows you, first to set site options, and then to log in to the Password Maintenance utility, following initial program installation, in order to create your own System Administrator account. The Kaye default System Administrator account is automatically deleted when you exit the Password Maintenance utility. You can then use your own account to perform all your system administration tasks. In this chapter you: • Start the program and log in to the Password Maintenance utility using the default System Administrator account • Set policies and preferences • Create your System Administrator account • Create other user accounts • Upgrade the AVS Firmware • Access the Validator AVS online Help
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 39 3.2 Logging in as a Default System Administrator The Kaye validation console boots automatically into the Kaye Operator windows account on startup. In the start menu, you can start the Kaye Validator AVS software or use Kaye legacy software (Administrator password required!). Figure 19: Login Screen Once you have started the Validator AVS software, login screen appears as shown in Figure 16 below. Figure 20: Login Screen 1. Enter “Kaye” in the User ID text box. “Kaye” is the default System Administrator user ID. The User ID text box is case sensitive. Please make sure you enter the default user ID exactly as it appears here. 2. Enter “411” in the Password text box, as one time default System Administrator password. 3. Press Login.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 40 After the initial Login you start directly with the creation of a new system administrator in the user management screen. Figure 21: New User Screen - Create initial system administrator 1. Press the blue “New User” button and create a system administrator. The fields with red asterisks are mandatory: User IDs are unique and the password is following the default rules for passwords (minimum of six characters). 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 cannot be used by more than one active account. 2. 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. 3. Enter your password again in the Confirm password field and press OK. At this point you should record your user ID and password for future reference. You need both to log in to the Validator AVS. If you do not enter the correct user ID/password combination, you will be denied access. For the initial system administrator the User Type and User privileges are preset. You can enter a title, phone and email and even associate a picture by using the build in camera. After creating the new system administrator, by pressing “Save” the software automatically logs out. From now on the initial Kaye/411 user is not available anymore. The next time you log in to the Kaye Validator AVS Software, you will need to enter your own System Administrator user ID and password. The system is able to identify you by name using your unique user ID and password combination. The Main screen appears (see below). You are now ready to create other accounts and set the preferences and policies as required.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 41 3.2 Logging in as a Default System Administrator (cont.) Figure 22: The Main Screen 3.2.1 Creating New System Administrator Accounts Once you are logged in with the new system administrator account, you can add users to the system and set site options. Note: A good practice is to establish more than one individual with Administrative functions. This way the Administrative functions can still be accessed even if one of the System Administrators is unavailable. To create a new System Administrator account: 1. Press the Admin pane on the main screen. The Admin Settings window opens at the Preferences tab. 2. From the Admin Settings window, press User Management. 3. On the User Management screen, press New User, and enter your name in the Name text box.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 42 3.2.1 Creating Your System Administrator Account (cont.) Figure 23: User Management Tab The name you enter here displays later in the active user list on the left side of the screen. In contrast to the User ID, the User names are not unique. Once you have added your name to the active user list, you can enter the same name again. Your name is associated with the user ID/password combination that you entered. You use this user ID/password combination to log in to the Validator AVS. 4. 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. 5. 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. 6. Enter your password again in the Confirm password field and press OK. At this point you should record your user ID and password for future reference. You need both to log in to the Validator AVS. If you do not enter the correct user ID/password combination, you will be denied access.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 43 3.2.1 Creating Your System Administrator Account (cont.) 7. Enter your designation and your contact names. As a system administrator, you should give yourself all User Privileges listed below. Press Save to save your information. The User Management screen displays the list of active users. The System Administrator accounts you just created is the only name on the list (the default System Administrator account Kaye has been deleted). Now you are ready to add users to the system. 3.3 Creating New User Accounts When you create a new user account, the user name is added to the active user list. You assign a unique user ID for each user and a temporary password. The user have to change the password on the first login. To create a user account: 1. From the Admin menu, press User Management and then press New User. The New User screen gets active. 2. Enter the new user name in the Name text box. A user’s name is associated with the user ID that you enter in step 3. The name you enter here appears in the active user list. Note: User IDs must be unique. Once a User ID name has been used, it cannot be used again. 3. Enter the new account’s user identification in the User ID text box. The user ID can be any combination of numbers and characters. The user ID and password are case sensitive. A user ID may not be used by more than one active account. 4. Enter a temporary password for the user in the Password text box. The temporary password can be any combination of numbers and characters. The user will change this password when they first log in to the program.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 44 3.3 Creating User Accounts (Cont.) 5. Enter the temporary password again in the Confirm password text box. At this point you should record the new account’s user ID and temporary password. You will need to supply this information to the new user. A user ID and password is required any time a user: • Changes system preferences • Creates or modifies a setup • Changes the setup stored in the Kaye Validator AVS • Calibrates sensors or verifies sensor calibration • Manually stops sensor calibration or calibration verification • Manually starts or stops a qualification study or exposure cycle • Deletes or moves calibration or qualification data files • Accesses report utilities Note: A user account is not active until the user changes the temporary password when he or she logs in to the Console for the first time. 6. Set the default Designation by pressing the entry on the drop-down list. 7. Enter contacts in the Primary Contact and Secondary Contact text boxes. 8. Press on any specific permissions you wish to give a particular user. These permissions can include: • Create setup • Stop study • View or edit reports 9. Press Save. The User Management screen displays with the newly added user name in the user list
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 45 3.3.1 Deleting and Disabling User Accounts Beside the active users (marked with green color in the user management screen) there are two possible states for a user: Disabled user A user can be disabled by an Administrator or can get automatically disabled after three consecutive login failures if this option is enabled in the Policies (see Chapter 3.5 Setting Policies for details). A disabled user account is marked with red color in the user list but will stay in the alphabetic sort order of users. The disabled state is set with the checkbox “Disabled User Account” in the User Information. By unchecking an Administrator can re-enable the user account. Deleted User If a user account is not required anymore an Administrator can delete the account using the delete button at the bottom of the screen. In order to prevent discrepancies in the audit trail the user ID of the deleted user is block for further usage. The delete is marked in yellow and moved to the bottom of the user list automatically. The user information remains visible but is not editable and cannot be activated again. 3.3.1 One Time Emergency Access It is good practice to establish more than one active Administrator account. In case one system administrator is not available anymore the system can still be maintained. In case there is no known Administrator access anymore to the system possible Kaye can provide a one-time Emergency access with the sole purpose to add a new Administrator account. For this procedure the direct support of Kaye service is required. In the login screen without any user enter “Ctrl e” into the password field to start the emergency login. Please contact the Kaye support directly to receive the required information. The emergency access is logged in the audit trail.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 46 3.4 Setting Preferences Figure 24: Preferences Tab in the Admin Menu The Kaye Validator AVS software installs with default system settings. You can change any or all of the settings on the Preferences screen. The new settings become effective independently. 1. Use the keyboard to enter your company name. 2. Use the drop-down list to set the temperature units to Celsius or Fahrenheit. All calculations are performed in the temperature units specified here. The IRTD and the temperature reference (LTR –90, LTR –25/140, LTR –40/140, HTR 400, CTR –40, or CTR –80) are also programmed to operate in these units. IMPORTANT: If you create a setup using one temperature unit and then change units on the Preferences screen, you’ll be prompted to change to the new settings the next time you save that setup. However, only the label will be changed, not the temperature value. You need to make sure that all temperature values you entered are still appropriate for the new temperature units. For example, if you created a setup using °C, you may have entered 100.0°C as a calibration setpoint. If you change the temperature units to °F, the software will change the calibration setpoint to 100.0°F, not 212.0°F, changing the label from C to F but not the numeric value. If you want the setpoint to be 212.0°F, go to the Calibration screen and change the temperature value.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 47 3. Select the absolute pressure units for saturated steam calculations from the Pressure Units list box. If you selected “Other”, enter the value of 1 Atmosphere in the absolute pressure units you are using. 4. Press the 60 Hertz or 50 Hertz radio button to set the line frequency. Choose the setting that matches your environment. IMPORTANT: The aye Validator AVS filters noise induced by the AC Power in order to achieve its high accuracy performance. If the line frequency is not set correctly, the filter is not working correctly resulting in a higher signal noise level. 5. Press Yes or No to indicate if you want to enable a user to change lethality calculations parameters. 6. Enter the lower limit for IRTD stability (From 250 to 400°C or 482 to 750°F). The IRTD stability is fixed to 0.012°C but for high temperatures which threshold limit is set with this value, or temperatures below 0°C, the IRTD stability value becomes editable in the setup. 7. If necessary, you can enter an alternate machine identification number. The machine ID appears in the audit trail for identification of the console. 8. Logo: Import of a custom logo that can be any kind bitmap. 9. Display rate: Defines the rate the live data is updated in the monitoring view. It is not affecting the data storage rate as defined in the setup. 10. The path and folder that holds the Data Directory is displayed.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 48 3.5 Setting Policies Figure 25: The Policies Tab The Kaye Validator AVS software allows you to set policies that give users more flexibility how to handle the password system, lethality D-Value and the calibration warning. As the System Administrator you can adjust policies that: • Require minimum length passwords for all user accounts. • Set passwords to expire after a number of days. The user will be prompted to change their password once their current password has expired. By default, passwords are set to expire after 180 days. The software will display the password expiration date to the user at login when there are five days or less until their password expires. Expired passwords will not be accepted. • Disable user accounts after 3 unsuccessful login attempts. This option will disable a user account if there are three consecutive login failures at the PC for the same user ID. If a user account is disabled, only a System Administrator can enable the account again and assign a new temporary password.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 49 • Disable User IDs during entry masks the User ID entry similar to the password entry with dots in the login screen. • Disable the password system. User IDs and passwords will not be required to use the software. • Allow editing the D value in the lethality calculation. When this option is enabled, the D value field on the Lethality Calculations screen is editable in the setup. If this option is not enabled, the D value field does display but is not editable when creating a new setup. 3.6 Updating the Kaye Validator AVS Firmware Figure 26: The Firmware Upgrade Tab A new firmware release upgrade release for the Kaye Validator AVS can be applied using the AVS Firmware Upgrade tool from the Admin functions. For upgrading the Firmware please follow the steps exactly as outlined in the software: 1. Dock the console to the Kaye Validator AVS that is supposed to get upgraded Note: A remote upgrade using Ethernet or Wi-Fi is not supported! Press the “Get AVS SN” number to establish a connection to the Kaye Validator AVS. This assures the connectivity and retrieves the serial number for the audit trail entry.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 50 2. Insert a USB thumb drive with the firmware provided by Kaye into the USB port of the Kaye console on the backside of the Validator AVS. You can easily identify the correct USB port by referring to the displayed picture. 3. Now everything is ready to upgrade the firmware. Please make sure the Validator AVS is properly powered and not switched off during the upgrade process. Otherwise the system can be damaged and need to get restored in a Kaye Service Center. Press “Upgrade Firmware” and wait until a message tells you to restart the Kaye Validator AVS. 3.7 Handling Data Files The Kaye Validation console software allows to synchronize data across several consoles. The functionality is also used to backup, restore and archive files. The synchronization requires a location for the commonly used data. This can be any folder the Operating system can access for read/write operations, like a shared folder in the network but also an external drive or USB thump drive or a folder on the Kaye console itself. Please contact your system administrator for setting up a file location. The sync functions can be used for a simple backup but also to merge the data of several Validation console data sets following some rules for merging: - Preferences and Policies are not synchronized - If two items with the same name exists the item is updated with the latest version (depending on the modified date) in case for users and assets. - In case two items have the same name but different dates (reports, study files) both will be retained - The sync operations are started from the App command bar, accessible with a swipe from the button up or from the top down. When starting a sync operation the software firstly asks for the location.  Sync Out The Sync out function is used to copy the data content of the console to another file location. If the content of one console is copied to a dedicated folder it serves as a backup function. In case the data of two or more consoles synchronizes to the same folder the data is merged together which enables to build up a pool of shared data for a work group. It is selectable which data is actually copied. If an asset is selected the asset with all the information (setups, study files, reports, documents) is copied. It is also possible to select only one or a few assets to transfer these from one console to another but also possible to make a complete transfer with user, audit, equipment and asset data, depending on the setup.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 51 Figure 27: Sync Out selection box  Sync In The sync in functions copies data from a file location to the console. It can be used to restore data of a backup generated with the Sync out or Archive function. Like in the sync out function the user can select which data and which assets are copied to the console. In addition to the Data selection there’s a date filter to prevent old data to be copied to the console. The date filter specifies a time frame with simple dropdown selection. The copied data is merged with the existing console data. Figure 28: Sync In - Date Filter
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 52  Archive The Archive function works similar to the Sync out function except it will not copy but move files to a file location for archiving purpose, removing the files from the console. Therefore in addition to the Sync out function there is an archive date. All files that are older than the specified date are moved. Like in Sync out the assets can be selected individually. Figure 29: Archive Date Filter  AVS Convert The AVS Convert function imports single study files into the Asset system of the console. Single study files can be copied to disk out of the Asset details for importing them into another console or send them by email. Also the study files copied through the USB side port copies the files in a single file format that needs to be imported into the AVS software. Simply select a single data file in the browser, it is possible to add a comment for easier identification. If the corresponding asset is not existing already in the system, the software will now create a new asset and setup file from the information stored in the study file. Figure 30: AVS Convert – Import comments Note: Imported Validator 2000 files are not available under an Asset but in the report tool under the tile “Others”.
Chapter 3. Creating User Accounts Kaye Validator AVS User’s Manual 53 3.8 Online Help For online help, you need to swipe from the bottom or top edge for the app commands. There are two icons with a question mark, labeled as “Windows Help” and “Help”. While “Windows Help” shows the help screen of the operating system, the “Help” button displays context-specific help for that AVS application specific screen.
Chapter 4. Defining Equipment Kaye Validator AVS User’s Manual 54 Chapter 4. Defining Equipment Figure 31: Equipment Hub The Kaye Validator AVS software supports organizing the Kaye Validation Equipment. Accessed from the Main Menu, the Equipment hub displays Kaye equipment like Validator AVS, IRTD etc. as single tiles. Following functionality is provided: - Database of all used Kaye Equipment identified by serial number with calibration information and optional picture. - Calibration reminder based on the calibration reminder setting in the preferences and the calibration due date. - Search study files where a particular Kaye equipment was used. The search bases on the entered serial ID of the Kaye equipment and the automatically retrieved serial numbers saved within the study files. For temperature bath no serial is retrieved. Note: In the current software version IRTD serial search is not supported, yet.
Chapter 4. Defining Equipment Kaye Validator AVS User’s Manual 55 4.1 Adding New Equipment To add a new piece of Kaye equipment to your Kaye Validator AVS system, press the plus (+) icon on Equipment Hub screen. The New Equipment screen opens. Figure 32: New Equipment Screen You enter details separately for each new piece of equipment. Use the text boxes and drop-down menus to enter:  The Equipment Serial number as unique identifier  Last Calibrated Date  The model number  The Equipment Type  The Calibration Due Date You can also upload a bmp or jpeg image of the Equipment or access the camera to take a picture directly. When you have finished, press Save to save the entry and return to the Equipment Hub, or Cancel to reset entries on the screen.
Chapter 4. Defining Equipment Kaye Validator AVS User’s Manual 56 4.2 Checking Details for Existing Equipment To review the details for a particular piece of Kaye equipment press the tile for that particular item on the Equipment Hub screen. The Equipment Details screen opens. Figure 33: The Equipment Details Screen On the left side of the screen the details as follows are listed: • Serial Number • Date of last calibration • Due date for calibration • Model number • Equipment Type Press the Edit button to change any of these parameters. On the left side of the screen shows the study files associated to this equipment. In the funnel view, accessible from the equipment screen, it is also possible to filter a list of available studies by simply selecting the tile of the equipment. Note: In the current software version IRTD serial search is not supported, yet.
Chapter 4. Defining Equipment Kaye Validator AVS User’s Manual 57 4.3 The Calibration reminder The calibration build in calibration reminder supports the operator not to miss the calibration due dates. In the first step, it is necessary to activate and set the calibration reminder timeframe in the policies as described in 3.5 in this manual. As soon as the equipment calibration due date, as entered in the equipment details, is within the calibration warning message timeframe, the software will remind the operator: - In the Equipment tile in the Main screen the Equipment tile will display a number corresponding to the number of equipment due for calibration. - When opening the Equipment the tiles for equipment due for calibration will be displayed enlarged in light blue and showing the calibration due date directly within the tile. When the equipment is recalibrated the user needs to update the calibration data and the calibration due date manually.
Chapter 5. Defining Assets Kaye Validator AVS User’s Manual 58 Chapter 5. Defining Assets The Kaye Validator AVS includes an intuitive Asset Centric Data Management concept (patent pending) which allows you to store and access your data faster and more efficiently. Each individual process that you validate whether an autoclave or freezer etc. can be setup and defined as an asset. All files and data related to this asset, like setups, calibrations, or study files, are organized and accessed in one single screen around the basic asset data. It is even possible to upload additional documents like standard operation procedures or certificates and associate it with the asset. Assets can be sorted and searched by type, location, manufacturer etc. for easy access. To open the Assets Hub, press the Assets tile on Main Menu. The Assets Hub appears similar to Figure below. Figure 34: The Assets Hub The Asset Hub screen lists the various assets validated by your Kaye Validator AVS system. On the top text line, you can click on the category to display the assets by: • Type (sterilizer, dry heat oven, controlled temperature, etc.) up to 20 user-designated types • Model number • Size (in units of cubic feet, cubic meters, or cubic inches) • Manufacturer • Location
Chapter 5. Defining Assets Kaye Validator AVS User’s Manual 59 The asset tiles display each asset with type and model number. If the number of assets exceeds the screen size, scrolling and zooming enables viewing the other assets. To search for a particular asset, press on the Search (magnifying glass) icon, and a text box enables entering search data. For further details about a particular asset, press the tile for that asset to open its corresponding Asset Details window. To add one or more assets to the list, press the Plus icon (+) to open the New Asset creation window. Press the Back icon (the left arrow) to return to the main screen. 5.1 The Asset Details Screen To learn more about a particular asset, press on the tile for that asset on the Assets screen. The Asset Details screen (shown below) opens. Figure 35: Asset Details In the upper left, the title will be the type and name of the asset. The pane on the left displays up to three user-loaded photos (swipe to change to the next picture) of the asset, and lists the asset information as entered by the user with following data:
Chapter 5. Defining Assets Kaye Validator AVS User’s Manual 60 • Equipment ID of the asset: This is the internal asset number or serial number for unique identification of this asset. • Model: A model name or subtype can be specified • Manufacturer: Asset manufacturer name • Type: Categorization of the asset • Last validated: Date of the last validation as manually entered in the edit asset screen. • Validation frequency: At the upper right, tiles list the following categories associated with this asset: • Setups • Calibrations • Qualifications • Verifications • Reports • Documents The number on the tile represents the number of available files under this specific tile. Press on a given tile, and the lower right window displays the list of related data. For setups, the panel displays the latest setup files. If more setup files are in the database, the option, “Other Setups” shows the number of additional associated setups. Press a downward arrow to launch the Setup List page. On the list page, users can apply predefined Filter options (Status, Activity, Setup Name, Date, Comments, and Actions) to sort the files. You also start create a new setup by pressing the Create New Setup button. A setup for the Asset holds all information necessary to define the sensors, groups wiring diagram, calculations, calibration, verification and qualification parameters required for a validation study. The “(+) New” buttons creates a new setup from the scratch but it is also possible to copy existing setups from other assets as templates. Pressing the copy button beside the “New” button opens a list of all available setups on the machine. Depending on the number of assets and setups the population of this list might take some minutes. In this list the Assets are listed with names and setups listed with the setup name, number of sensors, comments and last modification date. The last column let you select the setups you want to copy to the asset. With the “Copy to drive” button it is possible to copy the selected setup file to a chosen folder. With the new Kaye Validator AVS system it is not necessary anymore to transfer setups via an USB thumb drive anymore. The functionally is purely for possible support analysis by the Kaye support that might request a setup file from the operator for analysis of issues with a study run. Every existing setup can be individually edited (by pressing the pencil button) or deleted (by pressing the trash bin button).
Chapter 5. Defining Assets Kaye Validator AVS User’s Manual 61 Calibrations, Qualifications and verifications are started from the setups page of the asset. Firstly select a setup to activate the initiate buttons. Pressing one of these buttons starts a calibration, qualification or verification. The “Hardware Discovery” screen will appear and the setup transferred to the selected Kaye Validator AVS. The Calibration tile provides a list of all available calibration study files with the setup name, the date, run number and comments. After selecting a study file, it is possible to seamlessly open the report tool and create the report from here. Similar to the setup files can be also displayed in a list, deleted or copied to a drive. Copied study files can be reimported to other Kaye Validation Consoles using the “AVS convert” import function of the command center. Under the Qualification and Verification tile, the similar functionality, starting the report tool, copy or delete files, is provided for qualification or Verification study files, too. For reports, the tile displays all already generated and available setup, calibration, qualification and verification reports. The documents are sorted under the tabs and can be directly displayed in the seamlessly integrated pdf-reader for review or printing. For documents, the pane provide option to upload any pdf documents related to the Asset like e.g. wiring diagrams, SOPs or calibration certificates.. 5.2 The New Asset Screen To enter a new asset into the Validator AVS system, go to the Asset Hub screen and press the plus (+) icon. The New Asset screen opens. Figure 36: New Asset Screen
Chapter 5. Defining Assets Kaye Validator AVS User’s Manual 62 You enter details separately for each new asset. Use the text boxes and drop-down menus to enter: • The asset name. Asset names have to be unique. Before synchronizing several asset data sets it is recommended to make sure that there are no duplicate names. • The Equipment ID: Equipment IDs have to be unique. • The type of asset: Any new type definition will be available in the dropdown in the future. Please be careful as also test types or wrong spelled types will be available in the dropdown. • The model number: Specifies the • The size in cubic units: In the dropdown it is possible to select the appropriate units or enter custom units. For the sort function only the number is used, therefore it is recommended to use a unified unit. • The manufacturer: Specify the manufacturers name • The Validation frequency: Specify the required validation frequency.  Location: Specify the location of the asset At the right, you can enter an optional Description of the asset. You can also upload up to three images of the unit to appear on the Asset Details screen, as well as a wiring overlay images that provides users of sensor placement on the asset. When you have finished, press Save to save the entry and return to the Asset Hub, or Cancel to leave the screen without changes.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 63 Chapter 6. Defining Study Setups Before you can run a qualification study, you must use the Kaye Validator AVS software to create or modify a setup. A setup defines everything required to calibrate sensors and run a qualification study. Note: To create or modify a setup, you must have permissions established by your System Administrator in the Admin menu (User Management tab). You access setups from the Asset Details screen, through the Setup pane. When you create a setup, you: • Define the sensors you are going to use in the study • Assign sensors to groups and generate a wiring diagram • Specify calculations and define group events to be monitored during the qualification study • Specify calibration and verification setpoints • Specify temperature stability and deviation criteria for sensor calibration and verification • Specify start and stop conditions for qualification and exposure cycle • Define the output relays After you have created and saved your setup, you can calibrate sensors and run a qualification study.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 64 6.1 Create a Setup File A setup defines everything required to calibrate sensors and run a qualification study for a specific asset. You create setup files from the Setup screens, from Setup pane in Asset Details. You must have permissions assigned by your System Administrator to create setups. Figure 37: The Setup Hub Screen To create a setup file: • From the Asset Details screen for a particular asset, press Setups. In the Setup pane Hub, press New Setup to enter the Study Details screen.  Now you can define sensors, assign sensors to calculation groups, set calibration parameters and criteria, specify the qualification cycle and save your setup. 6.2 Modify an Existing Setup The setup files for a specific asset are listed on the Setup screen. To modify an existing setup file: • From the Setup Hub screen for your asset, select the setup file that you want to modify You must have user permissions to modify a setup.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 65 6.3 The Define Setup Screen After you have pressed the New Setup button in the Setup Hub pane of Asset Details screens, the Define Setup screen opens. Figure 38: The Define Setup Screen Here you define the setup for a study. Use the text boxes or drop-down lists to enter: • The Setup Name • The Number of Sensors • The EQ ID • The SOP (Standard Operating Procedure) Protocol Number • The Load Description • Any Comments you wish to add. Note: The Setup name, Study type, and Number of sensors fields are mandatory. The Setup Name and Comment fields can accept alphanumeric characters and blanks, while the EQ ID, Load Description and SOP fields can also accept special characters (hyphen, underscore, forward and backward slash.) When you have completed entering asset data, press the Sensors Configuration button at the upper right to continue.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 66 6.4 The Sensors Configuration Screen From the Study Details screen, press Sensors Configuration to open the Sensors Configuration screen. Below the current study title, asset and ID number, the header row shows that you have reached the Sensors Configuration screen, in the setup creation process. Figure 39: The Sensors Configuration Screen The Sensors Configuration screen graphically represents the four Sensor Input Modules labeled SIM 1, SIM 2, SIM 3 and SIM 4. The numbers on the icons correspond to the numbers on the input connectors (up to 12) mounted inside the SIM. For an initial setup, all the input connector tiles are blue, to indicate that they have not been selected. Press an individual connector tile to select it, and the tile turns to dark blue, with a selection icon in the upper right corner. You can also select a series of sensors in the Select Sensors series of drop-down boxes at the right. Select a range of sensors from one SIM to another SIM, press Select, and those sensors all appear as selected on the left pane. To deselect a sensor, press on the individual sensor, or select a range of previously selected sensors on the Select Sensors pane, and press Select.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 67 Now that you have selected the sensors, you must configure them for the appropriate input type. Figure 40: Configuring Sensors IMPORTANT: If one sensor type is selected for a SIM, then all sensors in that SIM should be of the same type. Mixed sensor types are not allowed within a SIM. Open the Configure Sensors drop-down list, and assign the sensors in each selected SIM to one of the following color-coded types: • Thermocouple (Sub Types) J, K, T, E, B, R, S, N • Voltage • Current • Pressure (V or mA) • Contacts (Open/close, On/Off, 1/0). • RTD (PT100, 4-Wire)
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 68 For voltage, you can enter up to 3 decimal values in the input and output fields. The default values are: Input Min = 0.00 V, Input Max = 10.00 V, Output Min = 0.00 Output Max = 10.00. The input voltage range can be -1 to 12 V. For current, you can enter up to 3 decimal values in the input and output fields. The default values are: Input Min = 4.00 mA, Input Max = 20.00 mA, Output Min = 0.00, Output Max = 10.00. The range of input current is from 1 up to 25 mA. For pressure: You can enter up to 3 decimal values in the voltage input and output fields. The default values are: Input Min = 0.00 V, Input Max = 10.00 V, Output Min = 0.00 Output Max = 10.00. The input voltage range can be -1 to 12 V. You can enter up to 3 decimal values in the current input and output fields. The default values are: Input Min = 4.00 mA, Input Max = 20.00 mA, Output Min = 0.00, Output Max = 10.00. The range of input current is from 1 up to 25 mA. In the last step the sensor input is marked with a Description sensor label number, and to enable/disable auto numbering. Auto numbering is enabled only if more than one sensor is selected. After the sensor configuration pressing the Group Sensors tab to the right advances to the next screen.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 69 6.5 Understanding Groups Grouping is a key concept of the Kaye Validator AVS software. After your qualification study is complete, grouping allows you to customize your reports. Use the following guidelines when defining groups: • There must be at least one group defined in a setup. Each group must have a unique name. • Groups should be homogeneous (similar sensor types) since calculations are performed on all the sensors. • Sensors do not have to be in consecutive locations. You can assign any sensor from any SIM to a group. • You can assign a sensor to more than one group to relate the sensor’s output to different conditions. For example, you might have the same sensors in more than one group to look at data over different intervals. You could specify the maximum sensor reading during exposure for one group, and specify the maximum sensor reading during the entire qualification cycle for another group. • You must assign a sensor to a group to record data from that sensor. Any sensor not assigned to a group is considered unused and no data is recorded for that sensor.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 70 6.6 Assigning Sensors to Groups Figure 41: The Group Sensors Screen On the Group Sensors screen, sensors from any SIM are assigned to groups. The same sensor can be assigned to multiple groups. After the configuration of the sensors, the next step is to group them by pressing the Group Sensors button. The Group Sensors screen displays a scrollable listing of existing groups, as well as the New Group button. As long there is no group defined the “Default Group” button will automatically generate groups for sensors with the same measured variable, like Temperature, Voltage, Current etc. To assign sensors to groups: 1. Press on individual sensors to select them for the group. These sensors now appear as a deep blue with an orange checkbox. 2. Press the New Group button. A Group Name text box appears on the screen. The Group name text box should allow characters that can be upper and lower case, numerics, special character like hyphen, underscore, slash (forward and backward) and blank. Enter the name, and toggle the save button to save the group.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 71 The screen also offers the following options: • Delete - permits deletion of a group of sensor • Move Sensors - permits moving sensors to another sensor group (specified in drop-down list) • Add Sensors - allows users to add further sensors to a group • Wiring overlay – accessible via the book icon - enables displaying the wiring overlay graphic: Figure 42: Wiring Overlay Diagram In the wiring overlay one of the pictures predefined in the asset details can be chosen as a background while the sensors per group can be dragged into the picture to reflect the position during the study. The sensor positions are stored in the setup. The printer button enables the export of the wiring overly to a pdf file that can be uploaded to the asset with the upload document function in the asset details. When you have finished and saved your changes, press Calculations to proceed to the Group Calculations screen.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 72 6.7 Specifying Group Calculations Figure 43: Calculations Once you have defined sensors and assigned them to one or more groups, the next step is to specify the calculations to be performed on the group of sensors during the qualification study. Calculations include statistical, lethality, saturation pressure of steam and saturation temperature of steam calculations. The Statistical Calculations are all fixed preselected by default and will be all calculated. Note: Lethality calculations needs to be defined in the setup! It is also possible to define events to monitor during the study. These events are listed in the reports and can be imported into the define cycles screen of the reporting tool. When finished, press Calibration Parameters to enter the qualification parameters.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 73 6.8 Specifying Calibration Parameters Figure 44: Calibration Parameters Screen The Kaye Validator AVS provides both sensor calibration and calibration verification. Before performing a qualification study, calibrate the temperature sensors to correct raw temperature readings to a NIST-traceable temperature standard. During calibration the Kaye Validator AVS automatically corrects raw temperature sensor readings to a NIST-traceable temperature standard to compensate for any errors inherent in sensor materials, and stores these offsets in the associated SIMs. You can specify a two-point calibration, or a two-point calibration with one check point. Sensors that do not meet the calibration test criteria for uncalibrated sensors are marked as failed and are not calibrated. A Calibration signature will be matched before running a Qualification, Calibration or Verification process. Calibration and Verification Temperatures, chosen Set points, Stability criteria and Deviation criteria together constitute Calibration Signature.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 74 After the qualification study, it is recommended to perform a calibration verification to verify that the sensor readings are still within the process criteria. You can specify a one-point, two-point or three-point verification independently to the calibration criteria. If a sensor fails verification, the sensor is noted as failed but the readings are still reported. Calibration offsets are not changed during calibration verification. Set the calibration parameters by specifying:  Temperature setpoints for calibration. You have to specify a low setpoint and a high setpoint and optionally a check setpoint. If you specify low setpoint and high setpoint, the high setpoint must be at least 2° higher than the low setpoint.  Temperature setpoints for calibration verification to verify that each sensor is still within your process criteria. You must select at least one check point for calibration verification.  Sensor and IRTD stability in terms of temperature variation over a fixed time period. Stability is the amount of change that is acceptable over the fixed time period.  Deviation criteria for uncalibrated temperature sensors, and deviation criteria for calibrated temperature sensors over a fixed time period. Deviation is the difference in temperature between the sensor values and the temperature standard.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 75 6.9 Specifying Qualification Study Conditions • Specify the conditions that control your qualification study on the Qualification Parameters screen. From this screen you specify: • Qualification start/stop conditions - used to start and stop the qualification cycle manually or automatically • Exposure start/stop conditions - used to start and stop the exposure cycle manually or automatically • Data storage options - the rates at which data is written to disk during a qualification run • Output relay - the events that activate the two independent output relay When you have finished, press Review to check your entries and save the setup.
Chapter 6. Defining Study Setups Kaye Validator AVS User’s Manual 76 6.10 Reviewing and Changing the Setup Figure 45: The Setup Review Screen After you have finished entering qualification parameters, press the Review button. The Review screen opens, listing all the pertinent details about the setup you have just created. Review screen provide following actions you can take: • Copy as New Setup — allows copying the current setup as a new setup and saving it under a different name. • Create Setup Report — creates a setup report as pdf file for saving and printing. The screen also shows the following sections, each with an Edit icon to permit rapid changes: • Asset Details • Sensor Details • Calculation • Groups • Report Header • Calibration Parameters • Qualification Parameters Press Save to save the setup, or use the back button to exit the Setup menu without changes
Chapter 7. Calibrating and Verifying Sensors Kaye Validator AVS User’s Manual 77 Chapter 7. Calibrating and Verifying Sensors 7.1 Introduction Before you perform a qualification study, you should calibrate your temperature sensors to correct raw temperature readings to a traceable temperature measurement standard. You may also need to perform verification of the calibration to confirm the accuracy of a qualification study. You can perform automatic calibration only if your validation system includes a Kaye temperature reference (Kaye temperature bath) and a Kaye temperature standard (IRTD). The IRTD, a self-contained precision measurement standard that provides data directly to the Kaye Validator AVS, accurately measures the temperature of the standard. The IRTD provides a traceable standard that is used to correct the temperature readings of your thermocouples. The Validator AVS 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 chapter you: • Load a setup into the Validator AVS • Select sensors to calibrate • Run calibration The Kaye Validator AVS 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. With the Kaye Validator AVS, you calibrate sensors at a low setpoint and a high setpoint. When you start calibration, the Kaye Validator AVS 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 Kaye Validator AVS logs the stability readings to the calibration report file. The Kaye Validator AVS then computes and logs deviation on the uncalibrated sensors, and calibrates all sensors that passed the deviation criteria. Finally, the Kaye Validator AVS computes and logs deviation on the calibrated sensors for a specified time period.
Chapter 7. Calibrating and Verifying Sensors Kaye Validator AVS User’s Manual 78 The Kaye Validator AVS repeats this process for both setpoints. You can also specify a check point in your setup. During check point, the Kaye Validator AVS calculates and logs deviation on the calibrated sensors. When calibration is complete, the Kaye Validator AVS writes the calibration offsets, the serial number of the Kaye Validator AVS 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. Before you begin the calibration process: • Place the Kaye Validator AVS 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 may cause temporary temperature measurement errors. • To provide maximum accuracy during the calibration process, power up the Kaye Validator AVS and let it run for approximately 30 minutes in the operating environment where calibration is to be performed in order for the Kaye Validator AVS 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.
Chapter 7. Calibrating and Verifying Sensors Kaye Validator AVS User’s Manual 79 7.2 Loading a Setup into the Validator AVS Before you begin the calibration or calibration verification process, you have to load your setup into the Kaye Validator AVS. If a Kaye IRTD is used then connect Kaye IRTD to top port of the Validator AVS. 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 Kaye Validator AVS to stabilize (approximately 2 - 3 minutes) before calibrating sensors or verifying sensor calibration or you may see invalid sensor data displayed. You can also turn the Kaye Validator AVS off and then back on, and then calibrate your sensors or verify sensor calibration. To load a setup: • From the Main Menu go to the Asset details and then select a setup from list of available setups. Now the buttons for initiating a study are active, and pressing “Initiate Calibration” or “Initiate Verification” starts the corresponding process. Select the Kaye Validator AVS to use. The docking mode is already preselected but it is possible to select any AVS from the list populated after pressing the discovery button, of Kaye Validators AVS that are currently available through a network connection and idle. Select the desired Kaye Validator AVS and press the “Connect” button (see also Chapter 8 for details of selecting a Kaye Validator AVS). The Kaye Validator AVS loads the setup and reads sensor information. This process may take a few seconds to complete. The Console then proceeds to the Sensor Selection screen. Figure 46: Initiate a Calibration from Asset Setups
Chapter 7. Calibrating and Verifying Sensors Kaye Validator AVS User’s Manual 80 7.3 Selecting Sensors You select the sensors to be calibrated or verified on the Select Sensors screen. This screen (Figure below) lists all thermocouple sensors defined in the setup. Sensors that are not selected appear as plain blue, while selected sensors appear in their SIM row in deep blue with an orange triangle. For each SIM, you can select sensors individually or select all sensors in one step. Figure 47: Sensor Selection Screen • To select sensors individually, press the individual sensor tile. The icon color changes to deep blue and the check box is enabled. After you have selected and confirmed your sensors, press Initiate Calibration to start a new calibration, or Initiate Verification to perform a verification. (Press Cancel to discard the sensor selections and return to a fresh screen. Press the return button in the upper left to exit the option.) Note: Once you begin a new calibration, any offsets from previous calibrations will be lost.
Chapter 7. Calibrating and Verifying Sensors Kaye Validator AVS User’s Manual 81 7.4 Calibrating or Verifying Sensors The Calibration study can be started in the calibration study screen by pressing the start button. The Kaye Validator AVS automatically calibrates (or verifies) sensors at the setpoints defined in your setup. In case of a verification it is possible to change the checkpoint setting via the Criteria button before starting the run to allow to adapt to changed requirements. The hardware connections and the criteria as defined in the setup can be reviewed any time by pressing the corresponding buttons. Note: It is recommended to make sure live data is actually displayed from connected sensors and IRTD before starting the study. Figure 48: Calibration Study Screen The Kaye Validator AVS clears calibration offsets stored in the SIMs for the selected sensors, and establishes communications with the temperature reference and the IRTD. The Calibration screen displays the temperature readings and stability readings for each sensor being
Chapter 7. Calibrating and Verifying Sensors Kaye Validator AVS User’s Manual 82 calibrated, the temperature and stability readings of the IRTD, and the required setpoint. The header includes the study name, temperature point (high, low or checkpoint), and the Graph and List View icons. Under the header, three blocks correspond to the low, high and check points, with the temperature set points displayed at the top of each block along with °C or °F. Each block also has an interior header with the heads Temperature, Stability and Deviation. (On the first block, the additional header Label lists the relevant data for a particular label -- IRTD set point, SIM number, Sensor Label -- for each row. If the list exceeds the screen size, you can scroll vertically through the remaining data. The Stop Calibration button enables you to stop calibration. If the stability point for any particular sensor is reached, that point is replaced with a green tick mark. However, if the deviation of any sensor is not within the specified limit, the deviation appears in red. Note: All calibration offsets will be deleted from the SIMs if the calibration parameters or temperature units of the new setup are different than the calibration parameters or temperature units of the setup currently in memory. 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. 7.4.1 Automatic, Semi-Automatic or Manual Mode When you start calibration, the Kaye Validator AVS software detects whether or not a Kaye temperature reference and an IRTD are connected. Both are required for fully automatic operation. If either the Kaye temperature reference or the IRTD is not found calibration verification switches to semi-automatic mode. If neither can be found, calibration verification switches to manual mode. 7.4.2 Calculate 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), it is possible to change the IRTD stability value manually in your setup.
Chapter 7. Calibrating and Verifying Sensors Kaye Validator AVS User’s Manual 83 The stability calculation begins once the temperature reference is within 5 degrees of the setpoint. Sensor and IRTD readings are displayed on the Data screen with a red background until they reach stability. To achieve stability, the IRTD and all sensors must meet the stability criteria defined in the setup. When stable, the sensor and IRTD readings change to a green background. If any sensors fail to reach stability, the calibration process remains there. To terminate the calibration process, press Cancel. 7.4.3 Calculate Deviation of Uncalibrated Sensors When the IRTD and all sensors reach stability, the Kaye Validator AVS calculates deviation by comparing each uncalibrated sensor to the IRTD, and then logs the stability and uncalibrated deviation data to the calibration report file. The Kaye Validator AVS marks any sensor outside the deviation criteria as failed. When uncalibrated deviation is complete, the Kaye Validator AVS calibrates all sensors that passed uncalibrated deviation at the low setpoint. 7.4.4 Calculate Deviation of Calibrated Sensors The Kaye Validator AVS then calculates calibrated deviation. The corrected results for each sensor are compared to the IRTD, and logged and displayed on the Data screen every 5 or 10 seconds as per display rate for the time period specified in the setup. Sensors that fail the calibrated deviation evaluation are displayed with a red background, and marked as failed in the calibration report file. 7.4.5 Data Logging Complete at Setpoint When the Kaye Validator AVS finishes logging the corrected results, 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 Kaye Validator AVS automatically sets the Kaye temperature reference to the check setpoint. The only difference between the low and high setpoint calibration and the check setpoint is that calibration offsets are not changed during check setpoint.
Chapter 7. Calibrating and Verifying Sensors Kaye Validator AVS User’s Manual 84 7.4.6 The Graph View In the calibration study Graph View, the header consists of icons representing four SIMs, along with a summary. A drop-down list below these icons displays the setpoint Figure 49: Calibration Study -- Graph View On the graph, the temperature appears on the Y axis, while the highlighted X axis shows the stabilized IRTD temperature. All the sample points that lie within the deviation specified are displayed in green dots along with the label and the temperature point of the sensor. All the samples that deviated from the specification are displayed in red dots along with the label of the sensor, the temperature point of the sensor and the value that indicates how much the sensor is off. On the summary tab, the outliers of all the SIM are displayed, along with the SIM number, sensor label, the temperature point of the sensor and the value of how much the sensor is off. 7.5 Current Calibration and Hardware Connections Both List and Graph views display essential data:  Bath serial number  Hardware Connection status
Chapter 7. Calibrating and Verifying Sensors Kaye Validator AVS User’s Manual 85  Preview stability criteria  Calibration Checklist -- A calibration checklist allows users to keep track of their particular step in the calibration:  Temperature Reference Set  Sensors Stabilized  IRTD Temperature standard stabilized  Deviation calculated on uncalibrated sensors  Sensors Calibrated  Deviation calculated on calibrated sensors  Saving Calibrated Temperature to files  Calibration point complete A green check mark appears next to each step in the process when it is completed. 7.5.1 Reasons for Calibration Failure Calibration or verification might fail for one of four reasons: • Failed calibrated deviation • Failed uncalibrated deviation • Failed calibration due to Unstable IRTD and loggers • Failed calibration due to not enough data Data for a live calibration or verification refreshes every 5 or 10 seconds as per display rate.
Chapter 8. Viewing Live Data Kaye Validator AVS User’s Manual 86 Chapter 8. Viewing Live Data Once you have entered a setup into your Validator AVS, you can monitor live data or calibration or qualification study progress on the Console. 8.1 Select Validator AVS From the Main Menu the hardware area in the center displays a tile, Discover. Press this tile to open select Validator AVS window. Figure 50: Main Menu with Hardware Discover Tile The easiest way to connect to a Validator AVS is to dock the Validation console into the docking port of the Validator AVS. The Docking Connection is represented by the preselected orange “USB/Docking” Tile. Simply press “Connect” to connect to the Validator AVS. Pressing “Discover” will search the connected Networks (LAN or Wi-Fi) for available Validators. They are listed with blue tiles showing serial number and IP address. The tile for the currently selected Validator AVS has an orange triangle in the upper right corner. When connecting to a Validator in the network, on pressing “Connect” it is necessary to select a connection via Ethernet or Wi-Fi.
Chapter 8. Viewing Live Data Kaye Validator AVS User’s Manual 87 8.1 Select Validator AVS (cont.) Figure 51: Select Validator AVS Screen Note: In case a Validator AVS is not in the same IP segment the discover function will not find it. Nonetheless if the TCPIP address of the Validator is known and the connection not blocked the connection can be established by entering the IP address and adding the Validator AVS to the available devices manually. Press the tile for the Validator AVS you need to use, and then press Connect to establish the connection between the Console and the Validator AVS. For configuring the Wi-Fi connection select a Validator and press “Configure WiFi”. The connection needs to be established by docking (recommended) or Ethernet. Enter all the necessary information and after pressing “ok” the information is transferred to the Validator. The Validator will now use this information to connect to the specified Wi-Fi network and will be available with the “”Discover”-Button.
Chapter 8. Viewing Live Data Kaye Validator AVS User’s Manual 88 8.2 Monitoring Live Data The Monitoring screen displays live data. Pressing the Back (←) button returns to the Main Menu, which now shows the connected status along with a Disconnect option. Figure 52: Main Menu with Events Tile Figure 53: Current Events Screen In the Events connection specific events like SIM or Power-disconnects are listed.
Chapter 8. Viewing Live Data Kaye Validator AVS User’s Manual 89 8.2 Monitoring Live Data (cont.) In the Monitoring of Live data mode no study is running and the data collection structure (sensor & groups definition) is following the last transferred setup (To transfer a setup you need to start a study). If the Validator AVS is in monitoring status, you can switch between List and Graph view to see live data from the Validator AVS on the screen. Figure 54: Monitoring in List View Figure 55: Monitoring in Graph View
Chapter 8. Viewing Live Data Kaye Validator AVS User’s Manual 90 8.2 Monitoring Live Data (cont.) If the Validator AVS is in Qualification status, the live screen displays groups as defined in the study. Figure 56: Qualification Study in List View Figure 57: Qualification Study in Graph View
Chapter 8. Viewing Live Data Kaye Validator AVS User’s Manual 91 8.2 Monitoring Live Data (cont.) If the Validator AVS is in Calibration or Verification status, the live screen displays groups as defined in the study Figure 58: Calibration List View Screen
Chapter 8. Viewing Live Data Kaye Validator AVS User’s Manual 92 8.2 Monitoring Live Data (cont.) Figure 59: Calibration in Graph ViewScreen Figure 60: Calibration Parameter screen User can start the Qualification or Calibration from the Asset detail screen. Based on the user rights, user can stop Qualification or Calibration activity.
Chapter 8. Viewing Live Data Kaye Validator AVS User’s Manual 93 8.3 Check Communications Connections On any of the live data monitoring screens, you can check your communications connections by pressing the Hardware button. On the Hardware screen each hardware item (Kaye equipment) is shown with a communications link. Figure 61: Hardware Screen A Device Not Found status indicates that the hardware is not communicating and may not be connected properly. If the link to the Kaye Validator AVS is not responding, all links will be marked with a grey image of device. 8.4 Select a Temperature Standard If you have two IRTDs connected to the Kaye Validator AVS, IRTD on the upper port will be used as temperature standard. The lower IRTD port will display in the hardware screen or can be used to power a pressure transducer with a special cable. For calibration and verification studies only the upper port is recognized.
Chapter 9. The Qualification Study Kaye Validator AVS User’s Manual 94 Chapter 9. The Qualification Study 9.1 Introduction Once the setup is defined and loaded into the Kaye Validator AVS and the sensors are calibrated everything is ready to run a qualification study. The Kaye Validator AVS uses the qualification parameters defined in the setup to perform the qualification study. Depending on the start and stop qualification conditions and the start and stop exposure conditions defined the study performs a fully automatic qualification, a fully manual qualification, or a mixture of automatic and manual. For example, in the setup could be specified 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 Kaye Validator AVS performs calculations and compiles data for the qualification reports. Qualification data is always written to the Kaye Validator AVS internal memory. The Kaye Validator AVS provides 32GB of internal memory to maintain qualification data during a study. Once study is complete and stop qualification is executed the study data is saved into Validator AVS memory. Qualification data resides in the internal memory until it is transferred to the console. The Kaye Validator AVS is also equipped with a lithium ion backup battery to provide short-term power in case of AC power loss during the run. The intent of the battery is to provide sufficient time (approximately 180 minutes) so that you can perform an orderly shutdown of the system. When the Kaye Validator AVS detects that the AC power has failed and the system is running from battery, it display indication on front panel LED. When the battery has approximately six minutes of power remaining, the Kaye Validator AVS stops collecting data and closes its data files.
Chapter 9. The Qualification Study Kaye Validator AVS User’s Manual 95 9.1 Introduction (cont.) Note: In the event of power glitches or short-term drops in supply voltage (“brownouts”), there is a remote chance that the Kaye Validator AVS will fail to fall back to its backup battery. In this case, the Validator could reset and potentially lose any study data stored in internal memory. To prevent this from occurring, Kaye recommends connecting the Validator AVS to an Uninterruptible Power Supply (UPS) in areas likely to experience brownouts. When the qualification study is complete, reports can be generated to document the specifics of the study using the Kaye Validator AVS report generator. (See Chapter 10.) Before beginning the qualification study: • Place the Kaye Validator AVS in a location with stable and even temperature, not exposed to any local heat sources (i.e., close directly 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 AVS and let it run for approximately 30 minutes in the operating environment where qualification is to be performed in order for the Validator AVS to acclimate to the ambient temperature. • Position the sensors in the vessel or chamber (the asset) being tested.
Chapter 9. The Qualification Study Kaye Validator AVS User’s Manual 96 9.2 Load a Setup Before the start of the qualification process, make sure to load the defined setup for this asset from the Console into the Kaye Validator AVS.: • Select the predefined setup file for this asset • Load the setup into the Kaye Validator AVS IMPORTANT: When loading 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 loading a setup with a different line frequency than the setup currently in memory, the Kaye Validator AVS must stabilize for approximately 2 - 3 minutes before running a qualification study or invalid data is displayed. 9.2.1 Select a Setup File If the setup is not yet created please see chapter 6 for instruction how to create a setup. If a setup for the asset is available, go to the Asset Details page and, from the Setup pane select the desired set up and press Initiate Qualification. The pop window gives the opportunity to change the SOP Protocol Number and display the run number. The run number is counting up automatically but is changeable if required. Pressing Ok opens the “Select AVS” screen.
Chapter 9. The Qualification Study Kaye Validator AVS User’s Manual 97 9.2.1 Select a Setup File (cont.) Figure 62: Select AVS Select now the Validator AVS to run the study. After pressing the “Discover” button the screen displays all the Validator AVS’ that are available. By default, the screen highlights the Validator AVS that was last used with this particular Console. It is possible to connect the Validator AVS in either of three ways: • Through the docking station • Through Ethernet - the screen displays a list of Validator AVS with same IP address or that are in range of the network. • Through Wireless connection - the screen displays a list of Validator AVS with same IP address or that are in range of the network. Press Connect to start the transfer of the setup for qualification study and proceed to the next screen, or press Cancel to return.
Chapter 9. The Qualification Study Kaye Validator AVS User’s Manual 98 9.3 Viewing the Active Qualification Study Figure 63: Real-Time Readings The Study is started by pressing the Start Qual or by the automatic start condition defined in the setup (in that case the start button is not available). During the qualification study, real-time sensor readings and calculations for each group defined in the setup are displayed. Also view real-time events that apply to the whole study (start/stop qualification, start/stop exposure), as well as all group-specific events are displayed in the message window. Graph option enables to view the data graphically. When viewing sensor readings and calculations, the following guidelines apply: • Calculations are computed, events are monitored and displayed on the Console screen. • The resolution of sensor readings and calculation results is dependent on the lowest resolution in the group.
Chapter 9. The Qualification Study Kaye Validator AVS User’s Manual 99 9.3 Viewing the Active Qualification Study (cont.) • Open, under-range, over-range or failed sensors are not allowed to participate in calculations or events. • Each box lists the SIM number, group name, sensor label and associated measurand (temperature, humidity, pressure, etc.) If there are more sensors or calculations than fit on the screen, use the scroll bar to display the remaining data. • A button to stop qualification is available at the bottom of the screen. Data is refreshed as per display rate 5 or 10 seconds selected on preferences screen the rates shown below: Note: After disconnecting the console the Validator AVS continues the study. Live monitoring data are discarded after disconnecting and will resume on reconnecting the console. Depending on the setup the exposure can be started and stopped manually or will start automatically depending on the setup definition (in that case that “Start exposure” Button is not available). To stop the study, press the Stop Qual button. After stopping the study the Save Study button becomes available. Please save the study to your console. If a console is connected to a Kaye Validator AVS with an unread study it will insist on reading the study before starting any new study.
Chapter 9. The Qualification Study Kaye Validator AVS User’s Manual 100 9.4 Graph Real-Time Sensor Readings and Calculations Figure 64: Graphing Sensor Readings During the qualification data samples are displayed as per display rate. To graph real-time sensor readings and calculations: 1. Press the Graph View option. The Graphs screen displays. All the available Groups in that particular setup are displayed, when pressing the button for each group, the corresponding graph is displayed.
Chapter 9. The Qualification Study Kaye Validator AVS User’s Manual 101 9.4 Graph Real-Time Sensor Readings and Calculations(cont.) Figure 65: Qualification Parameters The criteria button displays the Qualification Parameters for reviewing the start and stop conditions for Qualification and Exposure. Figure 66: Hardware Screen On the hardware screen all available hardware connected to the AVS is available including serial numbers and calibration dates. In addition the Sensor Offsets can be reviewed.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 102 Chapter 10. Generating Reports 10.1 Reports Overview The Kaye Validator AVS software includes a comprehensive reporting utility that allows you to generate Setup, Calibration, Qualification, and Calibration Verification reports to document the specifics of your validation study. All reports are generated from secure data files that can only be read by the Kaye Validator AVS software. 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. Since reports are created each time from a secure data file, you can specify which groups to include in your Qualification Report. For qualification reporting, in addition to reporting the data that was available during the study, the software allows you to perform post-qualification analysis. You can add statistical calculations, events, and time intervals to your report based on the stored data. The secure data file remains unchanged; you can always access the secure data file to recreate reports using the Kaye Validator AVS software. Note: You can create Portable Document Format (PDF) files from the study data and then electronically sign the reports.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 103 10.2 Report Types 10.2.1 Setup Report The Setup Report documents sensor labels and definitions for each SIM, wiring locations, and the parameters for sensor calibration, qualification and system preferences. Individual group information includes the sensors assigned to that group, statistical, lethality, and saturated steam calculations, the event defined for that group, and group-specific information such as vessel ID, SOP/protocol number, load description, asset details (if associated with a report) and comments. Sensor calibration parameters can include high, low and check set point, Stability and Deviation criteria defined while creating the setup. Qualification parameters include Start stop conditions, scan rate and data storage. For current, voltage and pressure sensors, the report lists scaling information such as min and max of input and output. System preferences such as temperature units, pressure units, and line frequency also appear. The report header lists the date and time the report was printed, the setup name, your company name, the firmware and software version numbers, the date this setup was saved, and identifies the person who saved this setup. The Setup Report can be generated directly from the setup review page or using the reporting tool. • When you generate this report independent of the full study, you can use the Setup Report to check your setup configuration and/or as a guide for wiring SIMs.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 104 10.2.2 Calibration Report The Calibration Report documents the SIMs used in calibration by slot number and serial number, the calibration setpoints, stability and deviation criteria, and the evaluation of stability, deviation, and the results for each temperature setpoint. Note: If a sensor fails calibration, it is marked with a double asterisk (**) to the right of the value in the temperature column, and from then on it is marked as Failed. The report header lists the date and time the report was printed, and identifies the name of the setup used to calibrate the sensors, your company name, the Kaye Validator AVS serial number, and the firmware and software version numbers. 10.2.3 Qualification Reports There are two different reports that document the qualification study: the Qualification Detailed Report, and the Qualification Summary Report. 10.2.3a Qualification Detailed Report The Qualification Detailed Report organizes information for each group by sensor data and type of calculation (lethality, statistical, saturated steam). You can customize the Qualification Report by specifying the groups to be reported, add events based on the stored data, and add explanatory notes and comments to the beginning or end of the report. The report header lists the date and time the report was printed, the name of the setup the qualification study is based on, the name of the person who performed the study, your company name, the Kaye Validator AVS serial number, the qualification study run number, and the firmware and software version numbers. The overview section documents the groups included in the report, any sensors excluded from group calculations, the SIMs used in the study by slot number and serial number, and user comments added during post-qualification reporting.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 105 10.2.3 Qualification Reports (cont.) The following sections of the Qualification Report are documented on a group basis. Data is reported at the data storage rate specified in the setup or the print sampling rate defined in post-qualification reporting. When an event occurs, whether it is Start Qualification, Start Exposure, Stop Exposure, Stop Qualification, or one of the group events, the message appears in each section of the report with a snapshot of the data at that time. If this was a manual event, the name of the person who manually started or stopped the event is also printed. Data is displayed in columns with shaded areas to help you locate data associated with a specific time period. Sensors that are excluded from post-qualification calculations are marked with an asterisk (*). • The Sensor Inputs section documents the raw data collected during the study. • If you are conducting penetration studies, the Lethality Calculations section documents accumulated lethality for each sensor, and the minimum accumulated lethality value and its location. • The Statistical Calculations section documents the calculations specified in the setup and/or the calculations specified during post-qualification reporting. This section also documents exposure time, cycle time, and temperature standard readings. • The Saturated Steam Calculations section documents the saturation temperature of steam calculation and the saturation pressure of steam calculation. • The last section of the report, System Messages, consists of two parts. The first part describes events that occurred during the qualification study. These are the events that are common to all groups: • Start/Stop Qualification • Start/Stop Exposure The second part of this section documents event timer intervals added during post-qualification reporting.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 106 10.2.3b Qualification Summary Report The Qualification Summary Report summarizes your study. You can apply a number of calculations, and generate a variety of calculation graphs. The report header lists the date and time the report was printed, the setup name, your company name, the name of the person who performed the qualification study, the run number, the Kaye Validator AVS serial number, and the firmware and software version numbers. The overview section lists the groups included in the report, the date and time the study started and ended, the duration of the qualification study, the duration of the exposure cycle, the SIMs used in the study by slot number and serial number, and user comments entered during post-qualification reporting. For each group, the Summary Report documents interval calculations, lethality calculations, any sensors that have been deleted from group calculations, event messages generated during the qualification study, and group events that were added during post-qualification reporting. • For lethality calculations, the Summary Report documents the lethality calculation parameters, the lethality calculation condition, the lethality calculation start/stop times, and the minimum lethality for that group by sensor label, value, and location. • If you enabled the Lethality option on the Print Options screen, the total accumulated lethality for each sensor is reported. 10.2.4 Calibration Verification Report The Calibration Verification Report documents the SIMs used in calibration verification by slot number and serial number, the calibration setpoints, stability and calibrated deviation criteria, and the evaluation of stability, deviation, and the results for each temperature setpoint. Note: If a sensor fails calibration verification, it is marked with a double asterisk (**) to the right of the value in the temperature column, and from then on it is marked as Failed. The report header lists the date and time the report was printed, and identifies the name of the setup used to verify sensor calibration, your company name, the Kaye Validator AVS serial number, and the firmware and software version numbers.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 107 Validator AVS Audit Trail The Kaye Validator AVS audit trail provides a complete listing of events that affect the integrity of the Kaye Validator AVS PC program and the Kaye Validator AVS instrument. Audit trail events are stored in secure data files to help you meet 21 CFR Part 11 requirements. 10.2.5 Audit Trail The Kaye Validator AVS software maintains the audit trail, which contains all events and identifies the type of action performed, the date and time the action occurred, the user ID of the responsible operator, and any additional information required to understand the action taken. A new audit trail file is automatically created each month and placed in the Kaye Validator AVS application folder. When running the Kaye Validator AVS in standalone mode, each Kaye Validator AVS maintains its own audit trail events which identifies the type of action performed, the date and time the action occurred, and any additional information required to understand the action taken. The program extracts the Kaye Validator AVS audit trail events when the program establishes communication with the Kaye Validator AVS. Each event is appended with the name of the responsible operator and added to the audit trail of the Console. Audit trail data is available to authorized personnel through the Audit trail tile. The System Administrator can: • View and print the audit trail Table 3 below includes a list of system and user-defined audit trail events.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 108 Table 3: Audit Trail Events User defined Events 0 - Undefined 1 to 96 - Sensor ID 97 - EventCond_MaxMinusAvg 98 - EventCond_MinMinusAvg 99 - EventCond_MaxValue 100 - EventCond_MinValue Audit Events EVENT_PROGRAM_START, EVENT_PROGRAM_CLOSE, EVENT_HMI_CONNECT, EVENT_HMI_DISCONNECT, EVENT_SIM_CONNECT, EVENT_SIM_DISCONNECT, EVENT_IRTD_CONNECT, EVENT_IRTD_DISCONNECT, EVENT_BATH_CONNECT, EVENT_BATH_DISCONNECT, EVENT_THUMBDRIVE_CONNECT, EVENT_THUMBDRIVE_DISCONNECT, EVENT_AC_POWER_FAILURE, EVENT_AC_POWER_RESTORATION, EVENT_POWER_FROM_BATTERY EVENT_BATTERY_AT_THRESHOLD, EVENT_BATTERY_LOW,
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 109 Table 3: Audit Trail Events (Continued) EVENT_VALIDATOR_SHUTDOWN_DUE_TO_LOW_BATTERY, EVENT_BATTERY_CHARGING_STARTED, EVENT_BATTERY_CHARGING_STOPPED, EVENT_FAN_FAULT,//2 fans EVENT_SETUP_UPDATED, EVENT_AUTO_QUAL_STARTED, EVENT_AUTO_QUAL_STOPPED, EVENT_MANUAL_QUAL_STARTED, EVENT_MANUAL_QUAL_STOPPED EVENT_AUTO_EXPOSURE_STARTED, EVENT_AUTO_EXPOSURE_STOPPED, EVENT_MANUAL_EXPOSURE_STARTED, EVENT_MANUAL_EXPOSURE_STOPPED, EVENT_AUTO_SENSOR_CAL_STARTED, EVENT_AUTO_SENSOR_CAL_DONE, EVENT_MANUAL_SENSOR_CAL_STARTED, EVENT_MANUAL_SENSOR_CAL_DONE, EVENT_MANUAL_SENSOR_CAL_TERMINATED, EVENT_SENSOR_CAL_VERIFICATION_STARTED, EVENT_SENSOR_CAL_VERIFICATION_SUCCESS, EVENT_SENSOR_CAL_VERIFICATION_FAILURE, EVENT_INST_CAL_STARTED, EVENT_INST_CAL_DONE, EVENT_INST_CAL_TERMINATED, EVENT_INST_CAL_VERIFICATION_STARTED, EVENT_INST_CAL_VERIFICATION_SUCCESS, EVENT_INST_CAL_VERIFICATION_FAILURE, EVENT_CALIBRATION_OVERDUE, EVENT_STUDY_COPIED_TO_THUMBDRIVE,
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 110 Table 3: Audit Trail Events (Continued) EVENT_STUDY_COPIED_TO_HMI, EVENT_OUTPUT_RELAY_ACTIVATED, EVENT_OUTPUT_RELAY_DEACTIVATED, EVENT_SBC_FW_UPGRADE, EVENT_DAQ_FW_UPGRADE, EVENT_POWERBOARD_FW_UPGRADE, EVENT_FILE_CREATION_FAILURE, EVENT_HMI_SUBSCRIPTION_FAILURE, EVENT_AUDIT_LOG_AT_THRESHOLD, EVENT_AUDIT_LOG_FULL, EVENT_AUDIT_LOG_CLEARED, EVENT_AUDIT_LOG_COPIED_TO_HMI, EVENT_TIME_SYNC, EVENT_CONDITION_OCCURED For a further explanation of audit trail events, refer to Appendix A.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 111 Figure 61: The Reports Hub 10.3 The Reports Hub Figure 67: The Report Hub Screen The Reports Hub enables users to access any report on the Console. To access the Reports Hub, press the Reports icon from the Start page. To study the content of a particular report, press the button for that report. The Report Analysis Screen opens
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 112 10.4 The Report Analysis Screen Figure 68: The Report Analysis Screen The header of the Report Analysis screen displays the type of the asset (e.g., Sterilizers or Autoclaves or Heat Chambers), ID, the activity and the date on which the run was performed. You can choose from different types of analyses for a qualification study: • Standard Reporting – summarizes the entire study. • Advanced Analytics – provides a more detailed analysis of the study. Press either Standard Reporting or Advanced Analysis to proceed to the Report Detail Screen.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 113 10.5 The Reports Details Screen Figure 69: The Reports Details Screen To access the Reports Details screen (which has data for any particular report selected through the Reports Hub), press the button for a specific asset on the Reports Hub. The header lists the particular asset for which you are looking up reports. A row below includes information such as Equipment ID, Water Spray, VRX-Fq1, Capacity and Manufacturer name. You can sort the reports by clicking on four subheads: • Activity – indicates if the report is based on setup, calibration, qualification or calibration verification. • Setup – lists reports by the setup name of the studies. • Date – lists reports by date.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 114 10.5 The Reports Details Screen (cont.) Use the up and down arrows to arrange the reports in ascending or descending order. A Comments column allows users to review the comments entered for a particular setup. The Actions column shows icons: • Graph - navigates to Summary/Advanced Analysis page and ask for Option to Select for unit  Temperature  Humidity  Pressure  Contact  Voltage  Current • Delete – Delete the selected file Figure 70: Report Detail Screen When Standard Reporting is selected
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 115 Figure 71: Report Analysis Screen when Advanced Analytics is selected
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 116 10.6 The Performance Analysis Screen Figure 72: The Data Sources Screen If user selects Advanced Analytics Option in Report Analysis Screen then from there it will be navigated to Report Detail Screen. In Report Detail Screen after selecting particular file data sources screen appears. If you highlight a study file and touch the forward (right) arrow, the file moves to the right panel, which displays the setup files selected for the report. (To remove the file from the report, touch the backward (left) arrow.) The selected files are highlighted in a mix of dark blue and orange on the left, while the unselected files appear in light blue. You can add up to three qualification study files. (A warning appears if you try to add a fourth study.) When you select two or three studies, the Synchronize button appears at the bottom of the right panel. If you press Synchronize, the data of the merged files appears in graph form in a sequence. When you press Data Sources, the screen displays two panels. The left panel, Add Source, with a More button that displays all other study files.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 117 10.6 The Performance Analysis Screen (cont.) Figure 73: The Performance Analysis Screen
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 118 10.6 The Performance Analysis Screen (cont.) Figure 74: Merged File Data At the right of each graph, a Sync Point text box allows you to enter the starting point of synchronization time in hh:mm:ss format. Three buttons appear at the bottom right: • Synchronize — Redraws the graphs with a user-defined starting point and the conclusion of the study as the end point. • Superimpose — Superimposes one file on another for comparative analysis. Press the Chart Properties button to edit Graph properties. Press back arrow to return to previous screen
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 119 10.7 The Standard Reporting Screen If user selects Summary Analysis Option in Report Analysis Screen then from there it will be navigated to Report Detail Screen. After Selecting Study file in the Report Detail Screen we will be moved to Template Selection Screen. 10.8 The Report Template Screen Figure 75: Report Template Screen If you have selected Summary Analysis at the Reports Analysis screen, once you have selected a particular file in Report Detail Screen after selecting particular file Template Screen Appears If you have not yet created any report templates, the drop-down list on the Template Analysis screen is initially empty. Once you have created templates, this list displays all the templates Note: If all the groups listed are empty, you cannot launch the Next screen until you have assigned sensors to at least one group in the Group pane.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 120 10.9 The Add Cycles Screen Figure 76: The Add Cycles Screen Define the start and end of the qualification cycle using either 1. Cycle selection box option (default) or 2. Time selection box.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 121 10.9 The Add Cycles Screen (cont.) Figure 77: Window with Cycle Names 1. Cycle selection box:  Move the slider in the center of the graph to mark either Start and End or Start or End of the study by clicking the OK button in Cycle selection box.  The left check box corresponds to the Qualification Start with the timestamp displaying at the bottom left side of the box.  The right check box corresponds to the Qualification End with the timestamp displaying at the bottom left side of the box.  The center of the cycle selection box displays the interval period corresponding to Start and End of cycle.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 122 10.9 The Add Cycles Screen (cont.) Figure 78: Cycle Name Box Define the data cycles  Move the cycle selection box slider to mark the Start & End of the cycle and click OK. The data is petitioned into either three or two cycles based on the left/right check box selection, with assigning the cycle names into the respective fields.  The timestamp for the start/end of the cycle in focus is displayed at the bottom of left right corners of the cycle selection box.  Maximum of 15 cycles can be defined.  All the cycles created above are now displayed under the Show Cycles dropdown list box at top Click Unmark Cycle/Unmark Cycles button in Show cycles window to remove the last cycle defined or all cycles at one shot respectively
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 123 10.9 The Add Cycles Screen (cont.) Time selection box: One can also define cycles by clicking the Mark Cycle by > Time Selection option. Enter the required time stamp(s) in the time selection window in DATE and HH:MM:SS format for defining Qualification Start and End. Figure 79: Added Cycle Screen By clicking Show Cycles down arrow, list of cycles will be displayed. UnMark Cycle button can be used to delete a cycle. This option deletes from the last cycle to first, end of study and then Start of study. UnMark All will unmark all the cycles, including study start and end.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 124 10.10 The Report Screen Figure 80: Report Screen This Screen Displays 1. Text Report: Which describes the Report after selecting cycle displays Report Options Screen and pdf file of qualification can be generated. 2. Customize Groups: we can edit already defined groups and save it for generating graph report and qualification Report. 3. Customize Calculations and modifications in Calculations can be customized and edited. 4. Graph Report: we can generate Graph for defined group and selected Cycle accordingly
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 125 10.11 The Graph Report Screen Figure 81: Graph Report Screen Depending on the sensor group and graph type selected, you can apply the following calculations: • Max Value • Min Value • Avg and Std Dev • Max-Min • Max-Avg
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 126 • Avg-Min • Lethality • Sat P • Sat T • MKT calculations Text boxes enable you to select the minimum and maximum values of the Y axis for the selected calculation graph. (These boxes accept only numerics, along with the minus sign, decimal point and comma.) Above the Groups/Sensors pane, three tabs allow you to select the Lethality, Saturation Pressure and Saturation Temperature calculations. • The Lethality calculation is available only if temperature sensors are present in the study. The left pane has the lethality graph for the entire study, while the right pane enables you to change the D, Z and Base temperature values. • The Saturation Pressure calculation is available only if the study includes at least one temperature sensor along with pressure sensors. • The Saturation Temperature calculation is available only if the study includes at least one pressure sensor along with temperature sensors. • No calculations are available for a contact sensor group. Based on the group selection, the following calculation graphs are generated: • Temperature Sensors • Temperature Sensors Calculations • RH (Humidity) Sensors • RH Sensors Calculations • Pressure Sensors
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 127 • Pressure Sensors Calculations • Current Sensors • Current Sensors calculations • Voltage Sensors • Voltage Sensors calculations • Contact Sensors • Lethality Sensor trends • Saturation Temperature • Saturation Pressure Note: For all types of graphs, Open, Under Range, Over Range or NO SIM sensor values are not displayed; for such failure values. Users can zoom in and out of any graph, or apply the print option to send graphs to a default printer. By default, the graph reports are saved with a unique name, along with the date and timestamp. Header and footer details remain the same as in all other reports.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 128 10.12 The Customize Calculations Screen Figure 82: Customize Calculations Once you have defined sensors and assigned them to one or more groups, the next step is to specify the calculations to be performed on the group of sensors during the qualification study. Calculations include statistical, lethality, interval, saturation pressure of steam and saturation temperature of steam calculations. To specify a calculation. If calculations have already been specified for statistical, lethality or interval calculations a Customize button displays to the left of the calculation label. Press the Customize button to change calculations. When user modifies lethality, interval, saturations calculations values they are applied to generate Report.
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 129 10.13 The Customize Groups Screen Figure 83: Customize Groups To assign sensors to groups: Press on individual sensors to select them for the group. These sensors now appear as a deep blue with an orange checkbox. Press the New Group button. A Group Name text box appears above the selected screens. Enter the name, and toggle the button to save the group. The screen also offers different options: • Delete - permits deletion of a sensor group • Move Sensors - permits moving sensors to another sensor group
Chapter 10. Generating Reports Kaye Validator AVS User’s Manual 130 10.14 Report Options Screen Figure 84: Report Options Screen When user selects Text Report Tile in the Report Screen it is redirected to Report Options Screen. The final step in setting up the report for printing is the selection of the report options. The first row header, “First Page”, display information as entered during study creation. At left side the Groups list, two editable text boxes, “Performed By” and “Reviewed By”, allow you to enter the names of users who conduct or review the study. Three check boxes enable you to indicate whether these names will be displayed on the First Page, Last Page or All Pages. Note: If you select All Pages, the other selection boxes are not available. Report structure can be customized
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Appendix A.. Understanding Audit Trail Events DRAFT Appendix A. Understanding Audit Trail Events All events include the following mandatory data: date and time, user name, user ID, Console ID, Validator ID and Console- Validator ID combination. Table 4: Audit Trail Events Tabulation 1 Users Create a user Date/time of event Create user Name of system administrator Name of new user Success or Failure Permission level Modify a user Date/time of event Modify user Name of system administrator Name of modified user Success or Failure Permission level Delete a user Date/time of event Delete user Name of system administrator Name of deleted user Failed login Date/time of event Login Failure Unknown user User ID entered Permission violation Date/time of event Permission violation Name of user Attempted action Password change Date/time of event User password change Name of user Success or Failure Back up passwords Date/time of event Passwords backed up Name of system administrator Restore passwords Date/time of event Passwords restored Name of system administrator Date/time of password file
Appendix A.. Understanding Audit Trail Events DRAFT Table 4: Audit Trail Events (Continued) Account disabled Date/time of event User account disabled Name of system administrator User name User ID Account disabled after 3 consecutive login failures Date/time of event User account disabled Automatic Event User name User ID Site Options Date/time of event Site options modified Name of system administrator Modification Preferences Date/time of event Preferences modified Name of user Modification Serial Numbers Validator Date/time of event Voltage calibration performed Name of system administrator Validator serial number, MAC SIM Date/time of event SIM calibration performed Name of system administrator SIM 1 serial number SIM 2 serial number SIM 3 serial number CONSOLE Date/time of event serial number Mac ID
Appendix A.. Understanding Audit Trail Events DRAFT Table 4: Audit Trail Events (Continued) Instrument Calibration Digitizer Date/time of event manufacturing Reference Voltage Date/time of event manufacturing SIM Date/time of event manufacturing Report Files Copy Calibration Date/time of event Calibration file copied Name of user who copied file Setup name User who ran calibration Date calibration started Source directory Destination directory Delete calibration Date/time of event Delete calibration file Name of user who deleted file Setup name User who ran calibration Date calibration started Source directory Destination directory Copy qualification Date/time of event Qualification file copied Name of user who copied file Setup name User who ran qualification Date qualification started Source directory Destination directory
Appendix A.. Understanding Audit Trail Events DRAFT
Appendix A.. Understanding Audit Trail Events DRAFT Table 4: Audit Trail Events (Continued) Delete qualification Date/time of event Delete qualification file Name of user who deleted file Setup name User who ran calibration Date calibration started Source directory Destination directory Copy calibration verify Date/time of event Calibration verification file copied Name of user who copied file Setup name User who ran cal verification Date cal verification started Source directory Destination directory Delete calibration verification Date/time of event Delete calibration verification file Name of user who deleted file Setup name User who ran calibration Date calibration started Source directory Destination directory
Appendix A.. Understanding Audit Trail Events DRAFT
Appendix A.. Understanding Audit Trail Events DRAFT Table 4: Audit Trail Events (Continued) Setup Files Create Date/time of event New setup created Name of user who created setup Setup name User who created Setup Date created Modify Date/time of event Setup modified Name of user who modified setup Setup name User who modified Setup Date created Delete Date/time of event Setup deleted Name of user who deleted setup Setup name User who created Setup Date created Miscellaneous PC program started Date/time of event Program launch Windows User ID of currently logged-in user PC program exited Date/time of event Program termination Automatic Event PC program exited due to 3 unsuccessful logins Date/time of event Login failure termination Automatic Event New audit trail Date/time of event Start audit trail Automatic Event
Appendix A.. Understanding Audit Trail Events DRAFT
Appendix A.. Understanding Audit Trail Events DRAFT Table 4: Audit Trail Events (Continued) Directory Restart due to tampering Date/time of event Tampering –restart audit trail Automatic Event Directory Back up audit trail Date/time of event backup Name of system administrator Directory Software upgraded Date/time of event Software version change Name of user who upgraded software Old version to new version Tabulation 2 SIM Connect and Disconnect Temperature bath Connect and Disconnect IRTD Connect and Disconnect Power Loss Under /Over Voltage
Appendix A.. Understanding Audit Trail Events DRAFT
Appendix B. Environmental Compliance DRAFT Appendix B. Environmental Compliance This appendix contains information on the following topics: • WEEE Directive (see Section B.1) • Battery disposal (see Section B.2) • FCC Part 15 details (see Section B.3) B.1 Waste Electrical and Electronic Equipment (WEEE) Directive 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 encourage 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.
Appendix B. Environmental Compliance DRAFT
Appendix B. Environmental Compliance DRAFT 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: • Cadmium (Cd) over 0.002% • Lead (Pb) over 0.004% • Mercury (Hg) over 0.0005%
Appendix B. Environmental Compliance DRAFT B.2.2 The Risks and Your Role 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.
Appendix B. Environmental Compliance DRAFT B.2.3. System Specifications Total System Specifications When you use specifications to compare equipment, be sure to establish an error budget that accounts for all possible measurement uncertainty. Sensor calibration is an integral part of validation, and 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, every potential error is significant. A summary of the error budget for a validation system after sensor calibration with type T thermocouples, used at steam and dry heat with a Kaye HTR-400 as temperature reference and a Kaye IRTD-400, is listed below. Kaye Validator AVS (resolution and short term stability) 0.017°C k=1 IRTD Temperature Standard (IRTD-400) 0.013°C k=1 Temperature Reference (HTR-400 @121°C) 0.051°C k=1 Accumulated Uncertainty (Route Sum Square) 0.055 °C k=1 Total System Uncertainty 0.11°C k=2 Kaye Validator AVS Specifications Analog Input Up to 48 Voltage Input Accuracy 30 days: ±(0.003% of reading + 2 counts + 4 microvolts) 1 year: ±(0.006% of reading + 2 counts + 4 microvolts) System accuracy with thermocouple (specified from 20 to 30°C for 30days) ±(0.003% of reading + 0.25°C) System accuracy with thermocouple (specified from 0 to 50°C for 30days) ±(0.028% of reading + 0.56°C) Sensitivity 0.5 microvolts/count on most sensitive range Voltage Temp. Coef. ±(0.1 microvolts + 0.001% reading)/°C Compensator Temp. Coef. ±0.01°C per °C Input Terminal Temperature Non-uniformity ±0.1°C from calibrated terminal Input Ranges -6 to 30mV, -12 to 60mV, -60 to 300mV, -2 to 10V Environmental Temperature: 0 to 50°C (32 to 122°F) Relative humidity: 95% non-condensing Power 90 to 250 VAC, 50/60 Hz Fuse Rating 4A Slow Blow Size 190H X 411W X 381 mm D (457 mm with SIM) 7.5 in H x 16.2 in W x 15 in D (18 in with SIM) Weight 10.60 kg (23.4 lbs) Battery Lithium ion with minimum 60 minutes of battery backup
Appendix B. Environmental Compliance DRAFT Console Specifications On Off (Storage) Temperature 5°C -40°C -20°C -60°C Humidity 8%-90% RH 5%-95% RH Air Pressure 697-1060 hPa 187-1060 hPa Power Supply (ITE) Delta Electronic, SADP-65NB Rev. BB Input : 1.5A, 100-240VAC, 47-63Hz Output:19V DC, 3.42 A The power supply is compliant with UL-60950-1, CAN/CSA C22.2 No.60950-1, and IEC/EN 60950-1 B.3 FCC Part 15 details This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. The manufacturer of this devise, as an intentional and / or unintentional radiator, cautions the user that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 15.105(a) “Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.” “Caution: To maintain compliance with the FCC’s RF exposure guidelines, place the product at least 20 cm from nearby person”
Appendix C. Safety and Precautions DRAFT Appendix C. Safety and Precautions Fallowing safety precautions should be taken for proper operation of the unit and to avoid any manual injury To ensure proper air flow, Fans should not be blocked The unit should be serviced by authorized service personnel only. This unit must be opened by Amphenol authorized service technicians only, tempering by unauthorized representatives could void the warranty This unit must be operated under specified environmental conditions only, usage of unit beyond these conditions could damage the unit and voids the warranty
Appendix C. Safety and Precautions DRAFT
Appendix D. Service Information DRAFT Appendix D. Service information We operate a global network of service centres and a field service organization to provide customer support for repair, returns, calibrations, technical support, evaluation and spare parts. Americas Amphenol Advanced Sensors 967 Windfall Rd St. Mary's PA 15857 USA Phone: 814-834-9140 Fax: 814-781-7969 Europe Amphenol Advanced Sensors Germany GmbH Sinsheimerstr. 6 75179 Pforzheim Germany Tel.: +49(0) 7231 14335 0 Fax: +49(0) 7231 14335 29 China Amphenol (Changzhou) Connector Systems Co., Ltd. Building 10, Jinton Industrial Park, No. 8 Xihu Road, Wujin High-Tech Development Zone, Changzhou, Jiangsu - 213164, China Tel.: +86-519-88311899 India Amphenol Interconnect India Pvt Ltd., Plot no.6, Survey No.64, Software Units layout, MAHAVEER TECHNO PARK, Hitech City, Madhapur, Hyderabad, Telangana – 500081, India Tel.: +91 40 33147100
DRAFT The language of touch With specific gestures on a touch enabled device, you can quickly perform key activities like Search and Share; there’s a corresponding command for using a mouse or keyboard, so you can interact in whatever way you prefer. Swipe from the right edge for system commands Swiping from the right side of the screen reveals the charms with system commands. Swiping from the left brings up previously used apps. Mouse equivalent Place the mouse pointer in the lower or upper-right corner of the screen Swipe in from the left to switch apps Swiping in from the left reveals thumbnails of your open apps so you can switch to them quickly. Mouse equivalent Place the mouse pointer in the upperleft corner, and click to cycle through apps, or in the lower-left corner to see the Start screen.
DRAFT Swipe in and out on the left to bring up previously used apps Swiping in and back out on the left brings up the most recently used apps and you can select an app from that list. Mouse equivalent Place the mouse pointer in the upper left and slide down the left side of the screen to see the most recently used apps Swipe from the bottom or top edge for app commands App commands are revealed by swiping from the bottom or top edge. You can swipe from the top to the bottom of the screen to dock or close the current app. Mouse equivalent Right-click the app to see the apps commands
DRAFT Press and hold to learn You can see details when you press and hold. In some cases, pressing and holding opens a menu with more options. Mouse equivalent Point to an item to see more options. Tap to perform an action Tapping something causes an action, such as launching an app or following a link. Mouse equivalent Click an item to perform an action Slide to drag This is mostly used to pan or scroll through lists and pages, but you can use it for other interactions, too, such as moving an object or for drawing and writing. Mouse equivalent Click, hold, and drag to pan or scroll. Also, when you use a mouse and keyboard, a scroll bar appears at the bottom of the screen so you can scroll horizontally.
DRAFT Swipe to select Within an app, swipe down or across an item to select it. A quick, short movement works best. On Start, press and hold to select a tile. Mouse equivalent Simply right-click to select within the app. Pinch or stretch to zoom Zooming provides a way to jump to the beginning, end, or a specific location within a list. You can start zooming by pinching or stretching two fingers on the screen. Mouse equivalent Hold down the control key on the keyboard while using the mouse wheel to expand or shrink an item or tiles on the screen. Rotate to turn Rotating two or more fingers turns an object. You can turn the whole screen 90 degrees when you rotate your device. Mouse equivalent Support for rotating an object depends on whether the specific app supports it.
DRAFT A Active Qualification Study ............................................................................................................. 98 Add Cycles ................................................................................................................................. 120 Assets Define ..................................................................................................................................................... 58 Detail ...................................................................................................................................................... 59 Hub ......................................................................................................................................................... 58 New ........................................................................................................................................................ 59 Audit trail Events ................................................................................................................................................... 107 Audit Trail ................................................................................................................................... 107 B Battery ........................................................................................................................................ 138 backup .................................................................................................................................................. 141 Disposal ................................................................................................................................................ 138 Replacement........................................................................................................................................... 21 C Calculation ........................................................................................................................... 72, 101 Graph ............................................................................................................................................ 100, 124 Reports ................................................................................................................................................. 124 Stability ................................................................................................................................................... 83 Calibration ................................................................................................................................... 36 Introduction ............................................................................................................................................ 77 Parameters ............................................................................................................................................. 73 Setup ................................................................................................................................................. See a Contact Connecting.............................................................................................................................................. 28 Current Connecting.............................................................................................................................................. 29
Index DRAFT Customize Calculations .......................................................................................................................................... 128 Groups .................................................................................................................................................. 129 Cycles ........................................................................................................................................ 120 D Data Requirement ....................................................................................................................... 10 Default System Administrator ................................................................................................... 38, 39 Define Setup ................................................................................................................................................ 63, 65 Defining Equipment ..................................................................................................................... 54 Detailed Report ............................................................................................................................ 104 Deviation Calibrated Sensors .................................................................................................................................. 83 Calibration Report ................................................................................................................................ 104 Calibration Verification Report ............................................................................................................. 106 Uncalibrated Sensors .............................................................................................................................. 83 E equipment Connect .................................................................................................................................................. 93 Specification ......................................................................................................................................... 141 Equipment Hub .......................................................................................................................... 54 Events Audit Trail ............................................................................................................................................. 107 Understanding Audit Trail .................................................................................................................... 132 Events Tile .................................................................................................................................. 88 F FDA Regulation ............................................................................................................................. 10 Fuse Replacement ...................................................................................................................... 36 G Group Assigning Sensors ................................................................................................................................... 70 Calculations ............................................................................................................................................ 72 Creating .................................................................................................................................................. 70 Live Data Graph ...................................................................................................................................... 90
Index DRAFT Understanding ........................................................................................................................................ 69 I IRTD ............................................................................................................................................ 31 Installation .............................................................................................................................................. 33 Specification ......................................................................................................................................... 141 K Kaye Validator AVS ....................................................................................................................... 1 Hardware .................................................................................................................................................. 6 Introduction ............................................................................................................................................ 15 Memory .................................................................................................................................................. 15 Shipping .................................................................................................................................................. 37 Time and Date ........................................................................................................................................ 36 L Live Data, Viewing ....................................................................................................................... 86 M Maintenance ................................................................................................................................ 36 Password ................................................................................................................................................ 38 Manual Calibration .............................................................................................................................................. 82 Explanation ............................................................................................................................................. 94 MANUAL Events ................................................................................................................................................... 109 N New Asset ................................................................................................................................... 61 O Operator ........................................................................................................................................ 10 Output Relay ................................................................................................................................ 17
Index DRAFT P Performance Analysis Screen .................................................................................................... 116 Policies ........................................................................................................................................ 48 Preferences ................................................................................................................................. 46 Q Qualification .................................................................................................................................. 12 Reports ......................................................................................................................................... 102, 104 Start ........................................................................................................................................................ 96 Study ....................................................................................................................................................... 94 Viewing ................................................................................................................................................... 99 R Real-Time Graph .................................................................................................................................................... 100 Sensor Readings ..................................................................................................................................... 98 Relay Rating................................................................................................................................. 17 Report Analysis Screen .............................................................................................................. 112 S Semi-Automatic ........................................................................................................................... 82 Sensor Input Modules (SIMs) .................................................................................................. 7, 22 Wiring ..................................................................................................................................................... 23 Setup Create ..................................................................................................................................................... 64 Defining .................................................................................................................................................. 63 Study ....................................................................................................................................................... 10 Understanding ........................................................................................................................................ 13 Stability Calculate ................................................................................................................................................. 82 Introduction ............................................................................................................................................ 77 Specification ......................................................................................................................................... 141 stop qualification ...................................................................................................................... 94, 99 Summary Report ......................................................................................................................... 106 System Connecting.............................................................................................................................................. 35 System Administrator Creating User Accounts .......................................................................................................................... 38
Index DRAFT Default .................................................................................................................................................... 39 Logging ................................................................................................................................................... 40 T Temperature Reference ............................................................................................................... 32 CTR ......................................................................................................................................................... 32 HTR ......................................................................................................................................................... 32 Installation .............................................................................................................................................. 33 LTR .......................................................................................................................................................... 32 U User Access .................................................................................................................................. 9 User accounts Disable .................................................................................................................................................... 48 User Accounts Creating .................................................................................................................................................. 43 V Voltage Connecting.............................................................................................................................................. 28 W Waste ........................................................................................................................................ 138 Batteries ............................................................................................................................................... 139 WEEE Directive .......................................................................................................................... 138
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