Download Print this page
Hide thumbs Also See for Validator AVS:

Advertisement

Quick Links

Kaye Validator
User Manual
®
AVS
M5100-EN Rev. L
May 2023
Validation

Advertisement

loading
Need help?

Need help?

Do you have a question about the Validator AVS and is the answer not in the manual?

Questions and answers

Summary of Contents for Kaye Validator AVS

  • Page 1 Validation ® Kaye Validator User Manual M5100-EN Rev. L May 2023...
  • Page 2 [No content intended for this page]...
  • Page 3 ® Kaye Validator Thermal Process Validation System User Manual M5100-EN Rev. L May 2023 Copyright © 2023 Amphenol Thermometrics, Inc. 967 Windfall Road St. Marys, PA 15857-3333, USA Web: www.kayeinstruments.com...
  • Page 4 [No content intended for this page]...
  • Page 5: Table Of Contents

    About this Manual ..................3 1.4. The Validator AVS System ................4 1.4.1. Validator AVS Hardware ................. 4 1.5. The Validator AVS Console / Software ............5 1.5.1. Study Setup .................... 6 1.5.2. Sensor Calibration .................. 7 1.5.3. Qualification Study ................. 8 1.5.4.
  • Page 6 Connecting the AVS Console to the AVS Hardware ........31 2.4.1. Connecting the AVS Hardware to Wi-Fi ..........34 2.4.2. Connecting via Wi-Fi: ................36 Joining the Kaye Console to a Company’s Domain ......37 2.4.3. 2.4.4. Fuse Replacement ................39 2.4.5.
  • Page 7 Contents 3.4. Setting Policies .................... 60 3.5. Updating the Validator AVS Firmware ............62 3.6. Handling Data Files ..................63 3.7. Online Help ....................68 Chapter 4. Equipment ................... 69 4.1. Adding New Equipment ................70 4.2. Checking Details / Studies for Existing Equipment ........71 4.3.
  • Page 8 Contents Chapter 7. Calibrating and Verifying Sensors ............ 93 7.1. Introduction ....................93 7.2. Loading a Setup into the Validator AVS ............95 7.3. Selecting Sensors ..................96 7.4. Calibrating or Verifying Sensors ..............97 7.4.1. Automatic, Semi-Automatic or Manual Mode ........98 7.4.2.
  • Page 9 Contents Chapter 9. Monitor Mode ..................115 9.1. Select Validator AVS ................. 115 9.2. Monitoring Live Data .................. 117 9.3. Check Communications Connections ............118 9.4. Sensor Offsets ................... 120 9.5. Access Study Files ..................121 Chapter 10. AVS Reports ..................122 10.1.
  • Page 10 The Risks and Your Role in Reducing Them ........180 C.2.3. System Specifications ................. 181 FCC Part 15 Details................... 182 Appendix D. Safety and Precautions ..............183 Appendix E. Service Information ................184 Appendix F. Warranty and Disclaimer: ..............184 Validator AVS User Manual...
  • Page 12: Chapter 1. Kaye Validator Avs

    1.1. Introduction Figure 1: 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 and manual sensor calibration / verification, qualification studies and reporting.
  • Page 13: 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 used as the operator interface to the Validator AVS. Selectable input capacity (1 to 4 SIMs) up to 48 total inputs.
  • Page 14: About This Manual

    Chapter 1. The Kaye Validator AVS 1.3. About this Manual The first section of this manual provides an overview of the Validator AVS hardware, instructions for creating user accounts, entering asset and equipment information, and an overview on using the Validator AVS software. The second section of this manual covers using the Validator AVS, calibrating sensors, running qualification studies, and verifying sensor calibrations.
  • Page 15: The Validator Avs System

    Validator AVS Console. 1.4.1. Validator AVS Hardware The Validator AVS is the heart of the Validator AVS system, and it can run as a standalone unit. All connectivity to sensors, calibration equipment, as well as the AVS console is done through the AVS.
  • Page 16: The Validator Avs Console / Software

    1.5. The Validator AVS Console / Software Figure 3: Validator AVS Console The Validator AVS system includes a portable, hardened dedicated validation Console running on Windows 10 LTSC. The AVS Console is pre-loaded with a customized Kaye core-load designed to meet data integrity requirements and limit applications to only those necessary for validation needs.
  • Page 17: Study Setup

    Define the output relays. After you have created and saved your setup, you run the study by loading the setup via connection from your Console to the Validator AVS. See also the Validator AVS online help for instructions on setting up a study.
  • Page 18: Sensor Calibration

    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 the reference. For sensor calibration instructions, see Chapter 7. Calibrating and Verifying Sensors.
  • Page 19: Qualification 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: ...
  • Page 20: Chapter 2. The Validator Avs Hardware

    Chapter 2. 2.1. Introduction The Validator AVS comes equipped with a universal power supply, a power cord for 115 VAC or 230 VAC, 32 GB of internal storage memory, and an USB flash drive interface. This chapter describes the Validator hardware and provides instructions for connecting the system.
  • Page 21: Connection Ports

    Chapter 2. The Validator AVS Hardware 2.1.1. Connection Ports The Validator AVS has connectors on the back of the unit for easy plug-in of SIMs, temperature standards, and temperature references. It also provides connection ports for USB and Ethernet for the Console and the AVS Validator. Another separate USB port is utilized for the yearly device calibration USB with ICAL software.
  • Page 22 There are three 4-pin DIN connectors, two for the IRTD and one for the 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 Ports There are two NO/NC relay outputs, labeled with a contact switch icon, to provide a dry contact to an external device.
  • Page 23: Led Panel

    When the AVS is running in Standalone mode without the AVS Console connected, the AVS LED panel can provide key status indications for the user. The front panel of the Validator AVS displays the machine status with four LEDs. These LEDs display red, green, or both colors, steady or blinking.
  • Page 24: Side Port For Data Transfer

    Chapter 2. The Validator AVS Hardware 2.1.3. Side Port for Data Transfer On its left side, the Validator AVS offers a side port with a USB port (to accommodate an emergency backup USB flash drive) and a data transfer button, as displayed in Figure 7 below.
  • Page 25: Avs Docking Mechanism

    The AVS hardware also contains a patented docking mechanism to connect the AVS Console to the AVS hardware. Figure 8 below displays the procedure for docking the AVS Console to a Validator AVS via its docking station. Figure 8: Docking and Releasing Console Note: The AVS Console can be docked to the AVS hardware with or without power applied to the AVS hardware or AVS Console.
  • Page 26: Internal Memory

    (approximately three hours) to complete your study or address the power failure. 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 displays the current battery state.
  • Page 27: Sensor Input Modules (Sims)

    2.1.7. Sensor Input Modules (SIMs) The Validator AVS accepts up to 48 inputs in any combination of thermocouple, voltage, current inputs, or 24 RTD inputs. The AVS uses Sensor Input Modules to provide secure connections for sensors to the Validator AVS, while also protecting the electronics from draft, dust, humidity, electrical noise, and mechanical shock.
  • Page 28: Wiring Sims

    IMPORTANT: SIMs are recognized by the system when you power up the Validator AVS. Ensure that all SIMs are connected prior to powering up the Validator AVS, or you should 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.
  • Page 29 Chapter 2. The Validator AVS Hardware To connect sensors to SIM locations: Loosen the two screws in the top of the module to open a SIM. Figure 11 below displays the inside of a thermocouple SIM. Figure 11: SIM Wiring Components: ...
  • Page 30 3 = Drain hole Tighten the two screws at the top of the module to close the SIM. 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 Z2612, “4 to 20 mA Sensor Input Module”.
  • Page 31: Connecting A Thermocouple

    (shown in Figure 14 below) on the outer insulation close to the SIM module to reduce the possibility of drawing moisture into the SIM. Note: The design of Kaye AUTOBOND wires eliminates any moisture seeping, making a drip cut unnecessary. Contact customer care for more information regarding Kaye AUTOBOND wire.
  • Page 32 Chapter 2. The Validator AVS Hardware Also, it is recommended to shave open approximately 1/4 inch from each of the inner wire jackets at opposite ends of the outer insulation drip cut. This permits condensation drainage from within the individual wires, as shown in Figure 15 below. If Autobond thermocouples are used, this is not necessary.
  • Page 33 Chapter 2. The Validator AVS Hardware 2.3.1b Connecting a Contact You can connect dry contact inputs directly to the TC-SIM, as shown in Figure 16 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.
  • Page 34 Chapter 2. The Validator AVS Hardware 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. 4-20 SIM to RH sensor wiring instructions: 1. Connect wire from + terminal of power supply to + terminal of the power connection on SIM.
  • Page 35 Chapter 2. The Validator AVS Hardware The 4-20 mA SIM can be configured in two ways based on the power connections. You can switch between external or local power, based on the placement of the jumper blocks as displayed in Figure 19 and Figure 20. Please refer to instructions on the SIM for current jumper placement and orientation.
  • Page 36 Chapter 2. The Validator AVS Hardware External Local External Local Figure 20: Configuration for Sensor with Less than 4 mA Power (Loop Powered Remotely) The red LED on the SIM is powered from the AVS and lights when the AVS is on and a SIM is plugged in.
  • Page 37: Kaye Irtd

    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.
  • Page 38: 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. Utilizing the supplied AVS to Temp Reference cable, attach it to the Temperature Reference icon located on the back of the AVS hardware.
  • Page 39 CTR -25 (setpoint range -25°C to 140°C) Liquid bath recommended for calibration of sensors used in freezers, cold rooms, incubators, and steam autoclaves. It is especially designed to hold up to 10 Kaye ValProbe logger but can also be used with up to 36 thermocouples.
  • Page 40: Sensor And Irtd Installation

    Chapter 2. The Validator AVS Hardware 2.3.1. Sensor and IRTD Installation The Kaye LTR-150, 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 results in reduced accuracy during calibration.
  • Page 41 Chapter 2. The Validator AVS Hardware CTR -80/-40/-25 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.
  • Page 42: Connecting The Avs Console To The Avs Hardware

    Validator AVS. Connecting the AVS Hardware to Ethernet Two Ethernet ports are located on the back of the Validator AVS. The icons alongside the ports indicate the device the port is connecting to. Simply connect the Validator AVS to a LAN network with an Ethernet cable.
  • Page 43 In the Startup screen, swipe from the right side or press the Pin button (see the arrows in Figure 21 below) to open the Windows Action Center. Inside the Windows Action Center choose Network. It is not necessary to log in as “Kaye Admin”. Figure 21: Startup Screen with Windows Action Center and Network...
  • Page 44 Chapter 2. The Validator AVS Hardware Inside Network a list of available network connections display. Ensure that the Wi-Fi tile is blue and switched on, otherwise press the Wi-Fi tile. In the example below, multiple networks are available: Figure 22: Startup Screen and Network Connections After choosing a network, connect by pressing Connect.
  • Page 45: Connecting The Avs Hardware To Wi-Fi

    Note: The SSIDs in the drop-down are copied from the console’s discovered Wi-Fi list. If you connect remotely to the Validator AVS via Ethernet, these networks may not be available in the remote location. Kaye Validator AVS User Manual...
  • Page 46 The Validator AVS is limited to 2.4GHz networks and the channels 1 to 11. 5Ghz networks and channels 12 to 16 are not supported.
  • Page 47: Connecting Via Wi-Fi

    It is now possible to undock the console from the AVS and still receive live data from the Validator AVS via Wi-Fi. Figure 25: Live Data Provided via Wi-Fi Connection Note: In Validator AVS machines without Wi-Fi modules any attempt to configure Wi- Fi results in the message “Wi-Fi configuration failed!”. Kaye Validator AVS User Manual...
  • Page 48: Joining The Kaye Console To A Company's Domain

    Chapter 2. The Validator AVS Hardware If the discovered Validator AVS has valid IP addresses for Ethernet and Wi-Fi, an option appears when pressing Connect. If only one IP address is available, the connection is established to this address only.
  • Page 49  Access permissions for the Kaye software should not be changed. Note: If a domain user logs into the console with his domain credentials, the Kaye Software Icons will not appear automatically in the Start Menu but must be picked from the Programs menu.
  • Page 50: Fuse Replacement

    Chapter 2. The Validator AVS Hardware 2.4.4. Fuse Replacement The Validator AVS is equipped with a 250V T 4A fuse. The fuse is in the line filter along with the power cord. To replace the fuse: Turn the power off.
  • Page 51: Chapter 3. Initial Avs Console/Software Setup

    In this chapter the following administrative functions are covered:  Start the program and log in to the Validator AVS software using the default System Administrator account.  Select security and Log-in authentication mode; Local security and Users or Active Directory™* (LDAP protocol).
  • Page 52: Logging In As A Default System Administrator

    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 Startup menu, start the Validator AVS software by double pressing the AVS icon. Figure 26: Desktop Screen...
  • Page 53 At this point, you should record your user ID and password for future reference. For the initial system administrator, the User Type and User privileges are preset. You can enter a title, phone number, and email and even associate a picture by using the built in camera. Kaye Validator AVS User Manual...
  • Page 54 From now on the initial Kaye/411 user is no longer available. The next time you log in to the Validator AVS Software, you will need to enter your own System Administrator user ID and password. The system can identify you by name using your unique user ID and password combination.
  • Page 55: Creating New System Administrator Account Local Security And Policies

    Your name is associated with the user ID/password combination that you entered. You use this user ID/password combination to log into the Validator AVS. Kaye Validator AVS User Manual...
  • Page 56: Setting Up Initial Administrator Using Active Director Security And Policies

    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.
  • Page 57 Note: To set up Active Directory™*, you must be an administrator with read rights to read your company’s Active Directory™*. Note: The Validator AVS software is only able to connect to one company’s Active Directory™* at a time. At the initial Login Screen, enter “Kaye” in the User ID textbox.
  • Page 58 Chapter 3. Initial AVS Console/Software Setup Figure 30: Policies Screen To enable the utilization of Active Directory™*, ensure the Validator AVS console is connected to the domain and select the ActiveDirectory User box. A window appears to define User Credential and Domain connectivity parameters.
  • Page 59 Once the Active Directory™* parameters have been defined and connection has been established, select Save to save settings. Use Kaye and 411 to verify the action or a local administrator account if you switch to Active Director™ later.
  • Page 60 Figure 33: Sync In Active Directory* Users and Policies The Active Directory* setup window has a feature that allows locally saved policies, parameters, and User Management definition to be Synced-In to other Validator AVS Consoles to avoid having to reconfigure them individually. From the Console with the configured Policies and User Management, open the Main screen>File...
  • Page 61: Adding / Managing User Accounts - Local Security

    Chapter 3. Initial AVS Console/Software Setup Important: For the Validator AVS system to operate there must always be an Administrator defined group. Upon first time startup of the system, the Administrator must define and set permissions for an Administrator Group.
  • Page 62 Select Save to save the information. The User Management screen displays a list of active Administrators accounts. The default Administrator Kaye account is deleted. Only Administrator accounts can enter the admin tile and create new Operator accounts.
  • Page 63 Enter a temporary password for the User in the Password textbox. The temporary password is any combination of numbers and characters. The User must change this password on their first Validator AVS software login. Enter the temporary password again into the Confirm Password textbox.
  • Page 64: Deleting And Disabling Local Security User Accounts

    The Users List generates a .pdf report that lists all active, disabled, and deleted User information. User Search A search field that filters for Username. As an example, if “B” is entered all usernames starting with “B” are listed. Note: All Users are listed in alphabetic order. Kaye Validator AVS User Manual...
  • Page 65: Local Security - One Time Emergency Access

    It is good practice to establish more than one active Administrator account, if a system administrator is unavailable the system is still maintained. If administrator access is not possible, Kaye can provide one-time Emergency access with the sole purpose of modifying an Administrator account. For this procedure, direct support from Kaye service is required.
  • Page 66: Adding / Managing User Accounts - Active Directory

    1. Define within your Active Directory™* company domain the desired Users and Groups for the Validator AVS system. 2. From the User Management screen, select the dropdown list under User List to display all groups in your company’s Active Directory™*. In case your group is not listed it is possible to switch from select to search mode.
  • Page 67 User is in both group A and group B as an operator user type, and someone makes a change for that user in group B, for example, to make them a System Administrator, they become a System Administrator in both groups. Kaye Validator AVS User Manual...
  • Page 68: Setting Preferences

    3.3. Setting Preferences Figure 40: Preferences Tab in the Admin Menu The Validator AVS software is installed with default system settings. You can change the settings on the Preferences screen. Changing system Preferences is an Administrator task and requires an Administrator account to edit the above defaults.
  • Page 69 Line Frequency: Use the dropdown to select a line frequency, 60 Hertz or 50 Hertz depending on your environment. IMPORTANT: The Validator AVS filters noise induced by the AC Power 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.
  • Page 70 Setup and Sensor Verification reports. Note, this is set directly in the reporting tool for qualification reports such as Detailed, Summary, and Pass / Fail.  Data Directory: Displays the path and folder of the Data Directory. Kaye Validator AVS User Manual...
  • Page 71: Setting Policies

    3.4. Setting Policies Figure 41: Policies Tab The Validator AVS software allows you to set security policies to comply with company policies and/or 21 CFR Part 11 regulations. Allowing users more flexibility on how to handle the password system, lethality D-Value and the calibration warning.
  • Page 72 Require Special Characters will enforce a password with increased strength by requesting at least one capital letter, a special character, and a numeric character in the password. This feature is only available if the minimum number of characters criteria is set as well. Kaye Validator AVS User Manual...
  • Page 73: Updating The Validator Avs Firmware

    This assures connectivity and retrieves the serial number for the audit trail entry. 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.
  • Page 74: Handling Data Files

    You can select data to be copied. If an asset is selected, the asset with all information (setups, study files, reports, documents) is copied. It is possible to select only one or a few assets to transfer these from one console to another, Kaye Validator AVS User Manual...
  • Page 75 The date filter specifies a time frame with simple drop-down selection. The copied data is merged with the existing console data. Figure 44: Sync In - Date Filter Kaye Validator AVS User Manual...
  • Page 76 Study files copied using the USB side port, copy the files in a single file format that requires importing into the AVS software. The AVS Convert function is primarily used by Kaye Technical Support. It allows customers to copy and send raw encrypted study files via e-mail to Kaye for analysis or review.
  • Page 77 The system requires the service MappedDriveHost running in the background for sync operations. Figure 47: Windows – Mapping a Drive When syncing from the software to a mapped location from the Validator AVS software: Browse to the mapped drive. It may be required to open the drive through the file explorer and the entering windows credentials for access.
  • Page 78: Auto Sync Function

     Auto Sync Function The Validator AVS software can automatically data sync to a remote network folder in a defined time interval. The setup for the sync location follows the same rules as described in manual sync out.
  • Page 79: Online Help

    Chapter 3. Initial AVS Console/Software Setup The Validator AVS software can sync data automatically to a remote network folder in a defined time interval. The setup for the sync location follows the same rules described for manual sync out and using a mapped network drive detailed on previous pages.
  • Page 80: Chapter 4. Equipment

    Calibration reminders are based on the calibration reminder setting in preferences and the calibration due date. Search study files where certain Kaye equipment were used. The search is based off the entered Kaye equipment serial ID and automatically retrieved serial numbers saved within the study files.
  • Page 81: Adding New Equipment

    Chapter 4. Equipment 4.1. Adding New Equipment To add a new piece of Kaye equipment to your Equipment assets, press the Plus (+) icon on Equipment screen. The New Equipment screen opens. Figure 51: New Equipment Screen Use the textboxes and drop-down menus to enter the following: ...
  • Page 82: Checking Details / Studies For Existing Equipment

    Chapter 4. Equipment 4.2. Checking Details / Studies for Existing Equipment To review the details and studies for a piece of Kaye equipment press the tile for that item on the Equipment screen. The Equipment Details screen opens (it may take several minutes to populate fully).
  • Page 83: Equipment - Calibration Reminder

    4.3. Equipment - Calibration Reminder The Equipment functionality provides a calibration reminder and visual alert to assist users with the maintenance of their Kaye equipment. When adding a new Equipment asset, the Calibration Due Date is manually defined. Inside User Preferences the Administrator can define the number of months from the due date to alert the Users.
  • Page 84: Chapter 5. Defining Assets

    To open the Assets Hub, press Assets on the Main Menu. The Assets Hub displays, as in Figure 53 below: Figure 53: Assets Hub The Asset Hub lists the various assets validated by your Validator AVS system. On the top text line, you can press the category to display the assets by: ...
  • Page 85: New Asset Screen

    Press the Back icon (the left arrow) to return to the Main screen. 5.1. 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.
  • Page 86 When you have finished, press Save to save the entry and return to the Asset Hub or Cancel to leave the screen without changes. Kaye Validator AVS User Manual...
  • Page 87: Asset Details Screen

    Last validated: Date of the last validation as manually entered in the Edit Asset screen.  Validation frequency. In the right pane, tiles list the following categories associated with this asset:   Setups Verifications   Calibrations Reports   Qualifications Documents Kaye Validator AVS User Manual...
  • Page 88 Simply select the Setup file and then the desired action to initiate. The Calibration / Verification tiles lists all raw encrypted calibration / verification study files. The file names include the setup name, date, run number, and comments. After Kaye Validator AVS User Manual...
  • Page 89 Copy Asset screen. It is required to enter a new name and ID for the asset. Select certain available setups to be automatically copied to the new asset. Figure 56: Copy Asset Screen Kaye Validator AVS User Manual...
  • Page 90: Chapter 6. Defining Study Setups

    Chapter 6. Defining Study Setups Defining Study Setups Chapter 6. Before you can run a qualification study, you must use the Validator AVS software to create or modify a setup. A setup defines everything required to calibrate sensors and run a qualification study.
  • Page 91: Create A Setup File

    Setup files for a specific asset are listed on the Setup screen. To modify an existing setup file: Select the setup file you wish to edit and press the Pen icon. Note: You must have user permissions to modify a setup. Kaye Validator AVS User Manual...
  • Page 92: Define Setup Screen

    The Setup Name and Comment fields can accept alphanumeric characters and blanks; the EQ ID, Load Description, and SOP fields can also accept special characters (hyphen, underscore, forward and backward slashes.) When all asset data is entered, press Sensors Configuration to continue. Kaye Validator AVS User Manual...
  • Page 93: Sensors Configuration Screen

    To configure, for example 24 thermocouples from SIM 1 and Sim 2, they must first be selected. If the sensors are not in consecutive channels, you can select each channel tile individually. As you do this the channels are marked with a checkmark indicating they are selected. Kaye Validator AVS User Manual...
  • Page 94 For most validation processes in the Pharmaceutical industry, Type T thermocouples provide the best accuracy within the range of -200C to 350C. It is recommended to utilize Type T (0.01C) resolution to maximize accuracy during calibration and qualification. Kaye Validator AVS User Manual...
  • Page 95 The acceptable input range is from 1 to 25ma. A 4-20ma SIM is required for current inputs.  Pressure - the AVS system can accept inputs from a Kaye or other pressure transducers. Select Voltage or Current, then select pressure for pressure sensors and the units of pressure assigned in the Preferences are utilized.
  • Page 96: Understanding Groups

     Utilize groups to perform validation of four separate freezers at the same time, each containing 12 sensors. These are but a few ways groups can enhance analysis and save time. Kaye Validator AVS User Manual...
  • Page 97: Assigning Sensors To Groups

    The Group Name textbox accepts characters that can be upper and lower case, numeric, special characters like hyphen, underscore, slashes (forward and backward), and blanks.  Enter a name and toggle the Save button to save the group. Kaye Validator AVS User Manual...
  • Page 98 The picture can be taken by double tapping the screen. Sensor tags can be moved via drag and drop to the position reflecting the desired or actual position on the asset. Wiring diagrams can be exported to a pdf using the Printer button. Kaye Validator AVS User Manual...
  • Page 99: Specifying Calculations

    Calculations for Statistical Lethality and Saturation are performed for all groups, interval calculations can be specific for each group. Note: If lethality is selected in the setup, the report tool requires the definition of an exposure cycle as mandatory. Kaye Validator AVS User Manual...
  • Page 100: Specifying Calibration Parameters

    Before running a qualification study, regulations require performing sensor calibration to maximize accuracy and ensure that the system meets required uncertainty criteria. During sensor calibration, the Validator AVS automatically compares each sensor to the IRTD (NIST-traceable temperature standard). The variation for each sensor at the low and high calibration point is stored in the SIM as an offset.
  • Page 101  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. Kaye Validator AVS User Manual...
  • Page 102: Specifying Qualification Study Conditions

    NTP server connection for automatic time setup. To utilize this feature, users must be assigned this privilege by an Administrator. Output relay - the events that activate the two independent output relays. When you have finished, press Review to check your entries and save the setup. Kaye Validator AVS User Manual...
  • Page 103: Reviewing And Changing The Setup

     Asset Details  Sensor Details  Calculation  Groups  Report Header  Calibration Parameters  Qualification Parameters Press Save to save the setup or use Back to exit the Setup menu without changes. Kaye Validator AVS User Manual...
  • Page 104: Chapter 7. Calibrating And Verifying Sensors

    With the Validator AVS, you calibrate sensors at a low setpoint and a high setpoint. When you start calibration, the 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.
  • Page 105 Before you begin the calibration or calibration verification process, you must load your setup into the Validator AVS. If a Kaye IRTD is used, connect the Kaye IRTD to the upper port of the Validator AVS. IMPORTANT: Connecting the Kaye IRTD to the lower connection port can result in distorted data in the calibration reports.
  • Page 106: Loading A Setup Into The Validator Avs

    After pressing Discover, available devices are displayed. Select the Validator AVS to be used for your Qualification study. Docking mode is preselected (highlighted in orange), but it is possible to select any Kaye Validators AVS that is currently available through a network connection.
  • Page 107: Selecting Sensors

    Initiate Verification to perform a verification (press Cancel to discard all sensor selections. Press Return in the upper left to exit.). Note: Once you begin a new calibration, any offsets from previous calibrations are lost. Kaye Validator AVS User Manual...
  • Page 108: Calibrating Or Verifying Sensors

    IRTD before starting a study. Figure 68: Calibration Study Screen When starting a calibration run the Validator AVS deletes all existing calibration offsets stored in the SIMs for the selected sensors. Next, the AVS establishes communication between the temperature reference and IRTD. The Calibration screen during the...
  • Page 109: Automatic, Semi-Automatic Or Manual Mode

    SIMs, and the calibration report file is deleted. 7.4.1. Automatic, Semi-Automatic or Manual Mode When you start a calibration, the Validator AVS software detects whether a Kaye temperature reference and an IRTD are connected. The Kaye IRTD is required for automatic or manual calibration.
  • Page 110: Calculate Deviation Of Uncalibrated Sensors

    To terminate the calibration process, press Cancel. 7.4.3. Calculate Deviation of Uncalibrated Sensors When the IRTD and all sensors reach stability, the 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.
  • Page 111: Graph View

    On the Summary tab, outliers of all SIMs are displayed, along with the SIM number, sensor label, temperature point, and a value indicating how much the sensor is off. The graph view is an efficient way to identify sensors that are not fully down the Temp Reference wells. Kaye Validator AVS User Manual...
  • Page 112: Current Calibration And Hardware Connections

     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. Kaye Validator AVS User Manual...
  • Page 113: Calibration / Verification Study File

    The Save Study button on the bottom right of the screen can be pressed and the raw encrypted Calibration / Verification file is copied from the AVS hardware to the AVS console and automatically placed in the Asset under the Calibration or Verification tile. Figure 70: Calibration Study Screen Kaye Validator AVS User Manual...
  • Page 114: Chapter 8. Qualification Study

    Console. Qualification data is always written to the Validator AVS internal memory. The 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) to allow you to complete the study.
  • Page 115: Loading A Qualification Setup

    A window opens prompting you to change the SOP Protocol Number and display the run number if desired. The run number is counted automatically but it is editable if required. Pres Ok to open the Select AVS screen. Kaye Validator AVS User Manual...
  • Page 116 Press Discover to display all the Validator AVS’. By default, this screen highlights the Validator AVS that was last used with the Console. Select the Validator AVS to run the Qualification study and then press Connect to start the setup transfer for the qualification study.
  • Page 117: Qualification Start / Stop Conditions

    Even a small discrepancy between clocks can cause potential confusion. Therefore, changing the time on a specific console to match other hardware can be a useful and important task. The AVS Console can have its time changed by doing the following: Kaye Validator AVS User Manual...
  • Page 118 Select Modify in the Set AVS System Clock and Console Time. Figure 75: Set AVS System Clock and Console Time Window Use the dropdowns to select the hour, minutes, and seconds of the new time. Figure 76: Time Dropdowns Kaye Validator AVS User Manual...
  • Page 119 The user is prompted to save the study. The Qualification file contains all data up to the time the study was aborted. Kaye Validator AVS User Manual...
  • Page 120: Qualification Real-Time Displays

    Chapter 8. Qualification Study 8.4. Qualification Real-Time Displays During the Qualification Study the Validator AVS software offers numerous real-time and historical displays to enable the User to easily evaluate and analyze the performance of the Qualification study. The displays include List, Graph, Overlay, and Interval Calculations.
  • Page 121 Y-axis by selecting the corresponding checkbox. The Y-axis can be scaled manually by entering min and max-values and then reset anytime to automatic scaling again. For better visualization of the process specification two limit lines can be set. Kaye Validator AVS User Manual...
  • Page 122 Historical Data View Figure 81: Historical Data in Graph View The Validator AVS stores the data of the current study in its internal memory. In addition to the real-time data view, it is possible to review this historical data at any time during a study.
  • Page 123 The Double Arrow on the left navigates directly to the first data chunk.  The Double Arrow on the right navigates to the live data screen and the headline of the graph displays real-time data. Pressing List View switches back to a sensor reading table view. Kaye Validator AVS User Manual...
  • Page 124 The layout view is only available if a wiring diagram is defined in the setup. When activating Sensor Value in Table, a table of live reading values are displayed in parallel with sensor labels and descriptions. Kaye Validator AVS User Manual...
  • Page 125 Note: Live screen interval calculations and the interval calculations report may show discrepancies if the storage rate is different from the display rate. To avoid such discrepancies, it is required to set the storage rate to the display rate. Kaye Validator AVS User Manual...
  • Page 126: Chapter 9. Monitor Mode

    Monitor Mode Chapter 9. The Validator AVS software has a Monitor mode which allows you to connect to a selected AVS hardware and view live data from an existing Setup on the AVS. Unlike Qualification or Calibration / Verification, no data is being collected/ stored, only displayed in real time.
  • Page 127 Figure 85: Select AVS Screen: Selecting a Validator Please see Section 2.4 (Connecting the AVS Console to the AVS Hardware) for detailed information on how to connect the Kaye Validation console to the Validator AVS. Kaye Validator AVS User Manual...
  • Page 128: Monitoring Live Data

    (sensor and groups definition) follows 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.
  • Page 129: Check Communications Connections

    On any of the live data monitoring screens, you can check your communications connections by pressing Hardware. On the Hardware screen, each hardware item (Kaye equipment) is displayed with a communications link. Figure 89: Hardware Screen A Device Not Found status indicates that the hardware is not communicating and may not be connected properly.
  • Page 130 Note: During Calibration / Verification the IRTD lower port is not used. Only the IRTD attached to the upper port is utilized. If the link to the Validator AVS is not responding, all links are marked with a gray image of device.
  • Page 131: Sensor Offsets

    SIM is not in the same slot as during the calibration. When reviewing the offsets, ensure that the system is calibrated correctly and ready for use in a study. Kaye Validator AVS User Manual...
  • Page 132: Access Study Files

    Chapter 9. Monitor Mode 9.5. Access Study Files The Validator AVS hardware automatically stores the last ten executed studies in backup memory. If the study file was not saved at the completion of the study from the AVS console, it is possible to use the Access Study Files to view and or retrieve these to the console.
  • Page 133: Chapter 10. Avs Reports

    Chapter 10. Reports Overview The Validator AVS software includes a comprehensive reporting tool which allows the documentation of all aspects of your Validation efforts. These reports give the flexibility to perform a thorough analysis of process performance, while meeting regulatory guidelines for 21 CFR Part 11 and Data Integrity guidelines.
  • Page 134: Setup Report

    Created date / time (with time zone)  Asset name  Asset ID  SOP #  User comments  AVS software and firmware versions The signature fields in the footer can be configured in the Admin / Preference screen. Kaye Validator AVS User Manual...
  • Page 135: Generating The Setup Report

    Created date / time / time User comments zone  AVS reporting software  Calibrated start date / time/  AVS Firmware version time zone The signature fields in the footer can be configured in the Admin / Preference screen. Kaye Validator AVS User Manual...
  • Page 136: Generating Sensor Calibration Report

    Standard Reports page. Select Standard Reporting, then the Calibration Report icon. After the Calibration report is generated, the software automatically loads the .pdf file into the Reports tile of the Asset for future retrieval and printing. Kaye Validator AVS User Manual...
  • Page 137: Sensor Verification Report

    Started by name  Asset name  Asset ID  AVS serial number  User comments.  AVS reporting software  AVS Firmware version Signature fields in the footer are configured in the Admin / Preference screen. Kaye Validator AVS User Manual...
  • Page 138: Generating Sensor Verification Report

    Standard Reports page. Select Standard Reporting, then the Verification Report icon. After the Verification report is generated, the software automatically loads the .pdf file into the Reports tile of the Asset for future retrieval and printing. Kaye Validator AVS User Manual...
  • Page 139: Chapter 11. Qualification Reports

    Qualification Reports Chapter 11. 11.1. Reports Overview The Kaye Validator AVS software includes a comprehensive reporting utility to generate Setup, Calibration, Qualification, and Calibration Verification reports to document the specifics of each validation study. These reports give the flexibility to perform a thorough analysis of process performance, while meeting regulatory guidelines for 21 CFR Part 11 and Data Integrity guidelines.
  • Page 140 Setup name  Created by  Created date / time  Asset name  Asset ID  SOP #  User comments Signature fields in the footer are configurable in the Admin / Preference screen. Kaye Validator AVS User Manual...
  • Page 141 Chapter 11: Qualification Reports Figure 91: Setup Report Kaye Validator AVS User Manual...
  • Page 142: Qualification Detailed Report

    The remaining sections of the cover page include, the groups included in the report, any sensors excluded from group calculations, the sensors used in the study by serial number, and any user comments added during post-qualification reporting. Kaye Validator AVS User Manual...
  • Page 143: Qualification Summary Report

    Max, Avg, Lethality, and Max-Min values for each cycle defined in the study (i.e., Heat up, Exposure, Cooldown). Included at the bottom of the Temperature Summary is a data summary for each cycle for all sensors in the group. Table calculations include: Kaye Validator AVS User Manual...
  • Page 144 Once groups are documented, the last pages of the report list System and Event messages and a footer. Before printing the Summary report, use the Report Content options to add Setup information or a graph of the complete study to the Summary report. Figure 93: Summary Report Kaye Validator AVS User Manual...
  • Page 145: Graph Reports

    Use the > or < to the right of the graph to maximized to full screen or minimized the graph. From the right pane, select data based on different calculations such as Statistical calculations, Lethality, Saturation Pressure and Temperature or Equilibrium to graph. Kaye Validator AVS User Manual...
  • Page 146 Each measured temperature and the calculated saturation temperature do not fluctuate more than 1 K.  All measured temperatures and the calculated saturation temperature do not differ from each other by more than 2 K. Kaye Validator AVS User Manual...
  • Page 147 Select OK to display the Equilibration Time graph. Important:  Excluded sensors from any graph reports are not included in the calculation graphs.  Groups with only one sensor have no statistical calculations available and the checkboxes are grayed out. Kaye Validator AVS User Manual...
  • Page 148 Important: Excluded sensors from any of the graph reports are not included in the calculation graphs. To include sensors in calculation graphs excluded previously for another graph view, select it again before switching to the next calculation graph. Kaye Validator AVS User Manual...
  • Page 149 Select Generate Report to create a .pdf report of the graph. Enter a custom label and select Apply. Use the option in the Summary Report to automatically include a completed study graph in the Summary report. Kaye Validator AVS User Manual...
  • Page 150: Audit Trail Report

    Chapter 11: Qualification Reports 11.5. Audit Trail Report To meet 21 CFR Part 11 and Data Integrity requirements, the Validator AVS system includes a robust and comprehensive Audit Trail. The Audited Trail automatically captures all system and Operator actions which affect the creation, modification, deletion, or storage of GXP data and reports.
  • Page 151  Validator AVS hardware serial number of units affected.  Validator AVS Console Machine ID to identify from which Console action was initiated. Use the drop downs above the header to find date specific data over a range and select the Get Data button. Select Reset to remove the date filter from the data.
  • Page 152 Qualification data. The tabs consist of: General Information Sensor Definitions Temperature Data Temperature Statistical Temperature Lethality Pressure Data Saturation P-T Messages and Comments Figure 97: Spreadsheet Report Kaye Validator AVS User Manual...
  • Page 153: Pass/Fail Report

    Qualification time stamps and associated data are captured:  At the time Events occur (i.e., Qualification Start / Stop, Exposure Start / Stop, or defined process events)  At User defined intervals based on configuration of the Sample/Storage rate. Kaye Validator AVS User Manual...
  • Page 154 A cycle is a defined period during the Qualification study. The Validator AVS software allows the User in the Setup report to define cycles (i.e., Qual Start to Qual End). Cycles can also be added or modified in the Reporting Tool prior to generation of reports.
  • Page 155 If for example, a data point (A1) has reached the given criterion threshold, the system checks if the next data point (A2) has reached the given criterion threshold as well. In that case, the interval between the data points are counted toward the accumulated value. Kaye Validator AVS User Manual...
  • Page 156 Once the template has been selected or defined the User can select which Groups to include in the report and used for the analysis. Each Group of sensors has their own analysis and report pages. Kaye Validator AVS User Manual...
  • Page 157 Temperature Fluctuation (Max-Min) per Sensor: The Temperature Fluctuation (Max- Min) per Sensor field defines the max fluctuation allowed for each sensor during the cycle. The criterion “Passes” if all sensors (Max – Min) readings are equal to or less than the defined criteria. Kaye Validator AVS User Manual...
  • Page 158 The criterion “Passes” if all the Group Avg-Min temperature timestamps are equal to or less than the defined criteria. Kaye Validator AVS User Manual...
  • Page 159 Min and Max allowable deviation from the measured temperature to the calculated Saturation temperature. The criterion “Passes” if all values are equal to or within the defined range. Kaye Validator AVS User Manual...
  • Page 160 “Passes” if the calculated time is equal to or below the defined criteria. If both Min and Max fields are defined the criterion “Passes” if the calculated time is equal to or within the defined range. Kaye Validator AVS User Manual...
  • Page 161 For each Group selected, the Criteria Evaluation page evaluates the performance of the calculated values against the defined criteria and indicates a “Pass” or “Fail”. If there is a “Fail”, additional information such as the failed Sensor ID and the timestamp of the occurrence is listed. Kaye Validator AVS User Manual...
  • Page 162 Failed sensors are marked with a red next to the failed criteria, providing valuable information as to which sensor or sensors caused the main criteria to “Fail”. Kaye Validator AVS User Manual...
  • Page 163 Account Manager. Figure 102: Failed Sensors Note: Users of the Kaye Report Tool acknowledge that the pass / fail criteria included in the software is not a substitute for calculation and analysis of pass / fail criteria by a skilled technician. The automated functionality for pass / fail is intended to be used as a guide only.
  • Page 164: Qualification Cei 60068 Report

    EMT/MET: Set the tolerances applied on the setpoint for the chamber to qualify. Uncertainty of the Sensors (Ucs): Set the uncertainty that you have calculated for your Validation equipment (Validator AVS, ValProbe RT, etc.). Average of the display: If you want to have a pass/failed status based on the display of the chamber to qualify, enter the average of the display during the study.
  • Page 165: Generating Qualification Reports

    Chapter 11: Qualification Reports 11.8. Generating Qualification Reports Before selecting a report type, the Validator AVS software permits the User a final opportunity to verify or edit parameters such as:  Start / Stop conditions (marking cycles)  Sensor groupings ...
  • Page 166: Mark Cycles

    Checkmark. Options such as the Zoom icons, adding Limit Lines or Selecting the Marker Position, improve the ability to accurately edit times. The process can then be repeated for any necessary edits to Qual / Exposure times. Kaye Validator AVS User Manual...
  • Page 167 Report and in the graph. The User can also specify "When" which defines when the event occurs, as well as a “Label” and the condition for the event (e.g., min temp > 100˚C). When all details are entered, select the Checkmark and the selected time is marked Kaye Validator AVS User Manual...
  • Page 168 In the Cycles window all created cycles are displayed with the defined Start and End times. The Cycles window also allows modifications of cycles names. UnMark Cycle is used to delete a cycle. Figure 108: Define Additional Cycles Screen Kaye Validator AVS User Manual...
  • Page 169: Edit Parameters

    Inside the Edit Parameters screen, you can make any necessary changes to Groups and or Calculations prior to reporting. Any changes to Groups or Calculations are listed in the reports. If no changes are needed, select the Next arrow at the top of the screen to proceed. Kaye Validator AVS User Manual...
  • Page 170: Edit Groups Screen

    Edit Group Sensors – select the pen icon in the appropriate group and then select or de-select appropriate sensors. Any changes to groups or removal of sensors are listed inside the report. Select Back to return to the previous screen. Kaye Validator AVS User Manual...
  • Page 171: Customize Calculations Screen

    Lethality and Time of Sterilization New European regulations have placed an emphasis on ensuring proper steam quality when calculating lethality. For this reason, Kaye has added additional options which if checked, only calculate the Instantaneous lethality for the timestamp if the Saturation Pressure and Temperature are within defined limits set in the Time of Sterilization calculation.
  • Page 172 Temperature (T-Sat) is within the specified range. Figure 112: Time of Sterilization – Definition of Limits Select Back to return to the Edit Parameters screen. If Edits are completed or no edits were required, select the Next arrow to proceed. Kaye Validator AVS User Manual...
  • Page 173: Report Selection

    Multiple reports may be selected at one time to improve efficiency. All generated reports are formatted in .pdf. All .pdf reports are automatically saved into the Asset where the Qualification file was stored and placed in the Report tile. Kaye Validator AVS User Manual...
  • Page 174 Setup – permits selection if a layout diagram is included in report. Figure 115: Setup Report Content Screen Summary – permits selection of groups included and Lethality or MKT calculations. Figure 116: Summary Report Content Screen Kaye Validator AVS User Manual...
  • Page 175 User Comments if added to the first and/or last page of the report.  Header Footer Titles customizable based on specific company needs.  Footer signature if added on first, last, or all pages.  System Messages to appear in reports. Kaye Validator AVS User Manual...
  • Page 176 This can minimize the pages printed while still providing granularity for calculations and graphs. Select Generate Report to generate the respective report types. Figure 121: Print Rate Kaye Validator AVS User Manual...
  • Page 177 [No content intended for this page] Kaye Validator AVS User’s Manual...
  • Page 178: Appendix A. Avs Calculations Lethality, Saturation, And Mkt Calculations

    Ileth and previous Ileth values. The data storage rate for a Qualification study should be as small as possible so that the Lethality calculation can account for any change in temperature. Accumulated Lethality = Kaye Validator AVS User’s Manual...
  • Page 179          -7.69123456  -2.60802370E+1  -1.68170655E+2  6.42328550E+1  -1.18964623E+2  4.16711732  2.09750676E+1 The second intermediate term is calculated:  term    1.0E+9  Kaye Validator AVS User’s Manual...
  • Page 180 P by the following formula:        The absolute temperature (in degrees K) is calculated by means of the following polynomial function:      3.7315985E+2  2.8009302E+1  2.3847554 Kaye Validator AVS User’s Manual...
  • Page 181  27315 , for temperature in degrees C (revised April 1987).  The absolute temperature is then converted to reduced temperature (alias Tr) by means of the following formula:    647 3 . Kaye Validator AVS User’s Manual...
  • Page 182 Thus, MKT may be considered as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variation. It is not a simple arithmetic mean. Kaye Validator AVS User’s Manual...
  • Page 183 AVG = (T ) / n Difference = (MKT-AVG) All calculation may be performed manually with a scientific calculator if a copy of Excel is not available. References Required:  USP24/NF19, <1151>Pharmaceutical dosage forms, stability Kaye Validator AVS User’s Manual...
  • Page 184: Appendix B. Understanding Audit Trail Events

    Name & ID of user Password of event password change change Date/time User Name & ID of user Name & ID of Account of event account system disabled disabled administrator Table 4: Audit Trail Events (Continued) Kaye Validator AVS User’s Manual...
  • Page 185 Name of the setup Name & ID of Setup of event Creation user Setup Name of the setup Modification Modified in tab Name & ID of user Setup Name of the setup Name & ID of Deletion user Kaye Validator AVS User’s Manual...
  • Page 186 Date/time Calibration Event timestamp of event Completed Name of the AVS Serial Number setup Date/time Calibration Event timestamp Calibration of event File Saved Name of the AVS Serial Number Name & ID of setup user Kaye Validator AVS User’s Manual...
  • Page 187 Date/time Verification Event timestamp of event Completed Verification Name of the AVS Serial Number setup Date/time Verification Event timestamp of event file saved Name of the AVS Serial Number Name & ID of setup user Kaye Validator AVS User’s Manual...
  • Page 188 Name of the Equipment Name & ID of Equipment of event creation user Equipment Name of the setup Modification Modified field Name & ID of user Equipment Name of the Equipment Name & ID of Deletion user Kaye Validator AVS User’s Manual...
  • Page 189: Appendix C. Environmental Compliance

    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. Kaye Validator AVS User’s Manual...
  • Page 190: Battery Disposal

    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% Kaye Validator AVS User’s Manual...
  • Page 191: The Risks And Your Role In Reducing Them

    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. Kaye Validator AVS User’s Manual...
  • Page 192: System Specifications

    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.
  • Page 193: Fcc Part 15 Details

    To maintain compliance with the FCC’s RF exposure CAUTION: guidelines, place the product at least 20 cm from nearby persons. Kaye Validator AVS User’s Manual...
  • Page 194: Appendix D. Safety And Precautions

    This unit must be opened by Amphenol authorized service technicians only, tampering 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. Kaye Validator AVS User’s Manual...
  • Page 195: Appendix E. Service Information

    Liability is therefore excluded to that extent permitted by law. Any proprietary rights of third parties as well as existing laws and regulations must be observed by the recipient of the product on his own responsibility. Kaye Validator AVS User’s Manual...
  • Page 196 Swiping in from the left reveals thumbnails of your open apps so you can switch to them quickly. Swipe in from the top to view a full-screened app's title bar. Swipe in from the bottom to view the task bar in full-screened apps. Kaye Validator AVS User’s Manual...
  • Page 197 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. Kaye Validator AVS User’s Manual...
  • Page 198 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. Kaye Validator AVS User’s Manual...
  • Page 199 Calculations ..........................161 Groups ............................160 Default System Administrator ......................42 Define Setup ............................ 80, 82 Defining Equipment ........................70 Deviation Calibrated Sensors ........................100 Uncalibrated Sensors ....................... 100 Equipment Connect ............................ 119 Specification ..........................182 Kaye Validator AVS User’s Manual...
  • Page 200 Assigning Sensors ........................87 Creating ............................87 Understanding ..........................86 IRTD ............................... 26 Installation ..........................29 Specification ..........................182 Kaye Validator AVS .......................... 1 Hardware ............................4 Memory ............................9 Shipping ............................. 40 Live Data, Viewing ........................116 Maintenance ........................... 38 Manual Calibration ..........................
  • Page 201 Stop Qualification ......................... 104 Summary Report ..........................154 System Administrator Logging ............................43 Temperature Reference ......................... 27 CTR ............................27 HTR ............................27 Installation ..........................29 LTR ............................. 27 User Accounts Disable ............................62 Voltage Connecting ..........................22 Kaye Validator AVS User’s Manual...
  • Page 202 Index Waste ............................179 Batteries ........................... 180 WEEE Directive ..........................179 Kaye Validator AVS User’s Manual...
  • Page 203 [No content intended for this page]...
  • Page 204 [No content intended for this page]...
  • Page 205 www.kayeinstruments.com © 2023 Amphenol Thermometrics, Inc. All rights reserved. Technical content subject to change without notice. M5100 Rev. L May 2023...