Validation Kaye ValProbe® RT User Manual MXXX-EN Rev. 1.
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Kaye ValProbe® RT Process Monitoring and Validation System User Manual M5XXX-EN Rev. 1.0 May 2020 Copyright © 2020 Amphenol Thermometrics, Inc. 967 Windfall Road St. Marys, PA 15857-3333, USA Web: www.kayeinstruments.
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Contents Kaye ValProbe RT System .........................................................1 1.1. Introduction ......................................................................................... 1 1.2. Operational Description ...................................................................... 2 1.3. Unpacking ........................................................................................... 3 1.4. Safety Information ...................................................................
Contents Creating User Accounts ..........................................................35 4.1. Introduction ....................................................................................... 35 4.2. Logging in as a Default System Administrator .................................. 36 4.3. Creating New System Administrator Accounts ................................. 38 4.4. Creating New User Accounts ........................................................... 39 4.4.1.
Contents 7.8. Specifying Qualification Study Conditions ........................................ 69 7.9. Reviewing and Changing a Setup .................................................... 70 Viewing Live Data .....................................................................71 8.1. Selecting a ValProbe RT .................................................................. 71 8.2. Monitoring Live Data ......................................................................... 72 8.3.
Contents 11.2. Qualification Detailed Report ...................................................... 102 11.3. Qualification Summary Report .................................................... 103 11.4. Graph Reports ............................................................................ 104 11.5. Audit Trail Report ........................................................................ 108 11.6. Spreadsheet Report .................................................................... 110 11.
Contents A.1.13 A.2 Optional Extendable Base Station Antenna ............................ 135 Kaye ValProbe RT Base Station .................................................... 136 A.2.1 Input Power and Adaptor Ratings ........................................... 136 A.2.2 Installation Category ................................................................ 136 A.2.3 Overvoltage Category and Electrical Safety Protection Class 136 A.2.4 Input DC Power On/Off Switch ................................
Contents A.3.12 Battery ..................................................................................... 138 A.3.13 Shelf Life ................................................................................. 138 A.3.14 Battery Life .............................................................................. 138 A.4.1 Measurement Accuracy ........................................................... 138 A.4.2 Body Environmental Ratings: ..................................................
Contents B.8 EU Compliance Statement: ............................................................ 144 B.9 ............................................................................................................. 144 Product Certification Labels ...................................................................... 145 B.9.1 Kaye ValProbe RT Base Station Label ................................... 145 B.9.2 Kaye ValProbe RT Logger Label ............................................. 145 Appendix C.
About this Manual The first section of this manual provides an overview of the ValProbe RT hardware, instructions for creating user accounts, entering asset and equipment information, and an overview on using the ValProbe RT software. The second section of this manual covers, using the ValProbe RT, including verifying sensors, running qualification studies, and generating reports..
Chapter 1: Kaye ValProbe RT System Kaye ValProbe RT System 1.1. Introduction Figure 1: The Kaye ValProbe RT The Kaye ValProbe RT is a wireless real-time process validation system designed around the measurement and reporting requirements of the Life Sciences and Food industry. The wireless and real-time aspect of the system make it ideal for harsh applications where the use of wires can be difficult to access and install.
Chapter 1: Kaye ValProbe RT System 1.2. Operational Description Figure 2: The Kaye ValProbe RT System The ValProbe RT system has three main components the Base Station, the Loggers, and the Console/ Docking Station. The Base Station is the main communication link/ hub between the Loggers and the Console. The Base Station and the Loggers communicate with each other via a star or point to point network using 2.4GHz frequency and a proprietary protocol which is compliant with IEEE802.15.4 protocol.
Chapter 1: Kaye ValProbe RT System The Base Station collects and stores the data from all loggers and provides communications to the Console. The default communication between the Base Station and the Console/Docking Station is via direct Ethernet connection utilizing a pre-configured Static IP address. An additional option is to connect the Base Station and Console / Docking Station to a network utilizing dynamic DHCP address which are software configurable.
Chapter 1: Kaye ValProbe RT System S.No Optional Accessories Qty 1 Kaye Validation Console with docking station and power adapter As per order 2 Logger transport/storage tray As per order 3 Kayetenna 2.5 / 5 meters (extendable autoclave antenna) As per order 4 Insulating Canister As per order 5 Logger AA Battery Extension Kit As per order Use ONLY Kaye #200-166 3.7 V lithium secondary (rechargeable) batteries inside the Base Station.
Chapter 2: Kaye ValProbe RT Hardware Kaye ValProbe RT Hardware 2.1. Kaye ValProbe RT Loggers There are eight Kaye ValProbe RT Loggers types: • Temperature - Measures temperature from –85°C to 140°C. The bendable Temperature Logger may be used in conjunction with an Insulating Canister to measure temperature up to 400°C. • Pressure and Temperature - Measures pressure from 0 to 5bar absolute and temperature from 0°C to 140°C.
Chapter 2: Kaye ValProbe RT Hardware IMPORTANT: To maintain the seal, the Logger contains a cup O-ring. The cup O-ring should be replaced whenever the Logger is opened. Temperature RT Loggers The Kaye ValProbe RT Temperature Logger accurately measures temperature from -85°C to 140°C using a precision Platinum RTD element. The RTD element is housed in the probe tip and ensures the following accuracy: Table 1: Temperature Logger Accuracy Temperature Accuracy -85°C to 140°C ±0.
Chapter 2: Kaye ValProbe RT Hardware 13 Kaye ValProbe RT G Single Bendable Temperature Logger XGBVP-L-RT XGDBVP-La-Lb-RT 14 15 16 Kaye ValProbe RT G Dual Bendable Temperature Logger Kaye ValProbe RT CR Rigid Temperature Logger Kaye ValProbe RT Pressure Temperature Logger L= Sensor length in inches T= Tip configuration pointed as (P) and round as R & Flat as (G) D= dual sensor X2535-RT X2532-RT The Temperature Loggers are available in different probe configurations (see Figures below).
Chapter 2: Kaye ValProbe RT Hardware Rigid Temperature RT Loggers The Rigid Temperature RT Loggers have a temperature range from -85°C to 140°C. They are a single sensor only, with a sensor length of 1.5”, 3”, 6”, or 9”, and have a diameter of 3mm / 0.118”.
Chapter 2: Kaye ValProbe RT Hardware Bendable Temperature RT Loggers Bendable Loggers are available in two versions, single and dual. They feature a temperature range of -85 °C to 140°C. If used with an Insulating Canister the range can be extended to 360°C. Sensors can be provided in 12”, 18”, 24”, 36” and 48”. The sensor tip diameter is 2.4mm, 0,98”.
Chapter 2: Kaye ValProbe RT Hardware Flexible Temperature RT Loggers Flexible Temperature RT Loggers are available as single, dual, or 5-sensor versions. They feature a temperature range of -85 ° to 140°C. The length of the sensor is 40” with a sensor tip diameter of 2.4mm, and tip length of 25mm; 0,98”. Figure 16: Flexible Temperature RT Loggers Surface Temperature RT Loggers Surface Temperature RT Loggers are ultra-flat surface sensors with a temperature range of -85 ° to 140°C.
Chapter 2: Kaye ValProbe RT Hardware Pressure/Temperature Loggers The ValProbe RT Pressure/Temperature Logger (X2532) can measure pressure from 0 to 5 Bar absolute using a strain gage pressure sensor, and temperature from 0°C to 140°C using a precision Platinum RTD element. Figure 18: Pressure/Temperature Logger CAUTION! Do not insert objects into the top of the Pressure Logger. This can damage the diaphragm in the Logger, invalidating the pressure readings.
Chapter 2: Kaye ValProbe RT Hardware Insulating Canister for High Temperatures The Kaye ValProbe RT Insulating Canister (Part Number X2545) enables you to operate bendable Temperature Loggers from up to 360°C by ensuring that the Logger base does not exceed 140°C. Figure 19: Insulating Canister (X2545) IMPORTANT: Use the Insulating Canister in air applications only; do not submerge the canister in liquid. CAUTION! Use the Insulating Canister in non-hazardous locations only.
Chapter 2: Kaye ValProbe RT Hardware Table 2 displays the length of time a Logger can remain in a chamber with the internal Insulating Canister temperature remaining below 140°C. Table 2: Logger Time Inside Canister Note: The table below assumes the Logger and Insulating Canister (including the cylinder) were initially at room temperature before being placed in the chamber and that the oven is stable.
Chapter 2: Kaye ValProbe RT Hardware Measurement Range and Accuracy The Kaye ValProbe RT Loggers are factory calibrated to the following accuracy specifications for one year: Table 3: Logger Calibration Accuracy Specifications Measurement Range Accuracy Temperature Loggers 0°C to 140°C ±0.1°C Bendable Temperature Loggers with Insulating Canister –80°C to –40°C ±0.1°C 140°C to 400°C ±0.25°C Pressure Loggers ±25 mb ±10 mb ±25 mb 0°C to 120°C 120°C to 135°C 135°C to 140°C 2.2.
Chapter 2: Kaye ValProbe RT Hardware 2.3. Logger Battery The Kaye ValProbe RT Logger contains a field-replaceable 3.6 VDC, Lithium Thionyl Chloride ½ AA battery. WARNING! To prevent ignition in a hazardous atmosphere, the battery must be changed only in an area known to be nonhazardous. Do not heat the battery above 140ºC. For measuring temperatures above 140ºC, a special probe and insulating canister are required to keep the temperature of the Logger below 140ºC for the duration of the study.
Chapter 2: Kaye ValProbe RT Hardware • If the battery is fully drained during a study, the study is terminated at the point the battery failed. Study data to the point of termination is stored in the Logger and can be read once a new battery is installed. • If a battery is fully drained after a study is complete, all study data can be read once a new battery is installed. • If you change the battery before a study is started, you need to re-program the Logger.
Chapter 2: Kaye ValProbe RT Hardware Figure 22: Remove the Old Battery and O-ring Install the Replacement O-ring and Battery Whenever you open a Logger, you need to replace the cup O-ring to ensure that the Logger maintains its seal. The ValProbe RT battery replacement kit contains two types of O-rings. • For temperature ranges from –85 to 140ºC, use the orange (silicone material) O-ring.
Chapter 2: Kaye ValProbe RT Hardware Important: If the LED does not blink, remove battery and wait (1-2 minutes) until all the residual power is released. Then use a magnet over the Logger without the battery. Reinstall the battery and wait for the LED to blink three times. If LED keeps blinking, remove the battery again and then reinstall the battery. If the Logger blinks more than three times, the Logger may have an issue with its hardware.
Chapter 2: Kaye ValProbe RT Hardware • Once the Loggers Status window displays, select the Loggers to reset from the lower left dropdown in the Logger Reset screen, and press Battery Reset. Figure 27: Logger Battery Reset • Select OK when prompted to continue the battery reset and then enter your user credentials. Figure 28: Logger Battery Reset Prompt • When all Logger battery resets are complete, ensure that their status displays Success in the Status column.
Chapter 2: Kaye ValProbe RT Hardware 2.4. Kaye RF ValProbe RT Base Station Base Station Overview The ValProbe RT Base Station acts as the central hub and communications link between the wireless Loggers and the ValProbe RT Console /software. The Base Station is responsible for establishing and maintaining wireless communications with the Loggers utilizing a 2.4GHz Star network with a proprietary and encrypted (AES128) protocol compliant to IEEE 802.15.4 standards.
Chapter 2: Kaye ValProbe RT Hardware Base Station IRTD / Bath Connections At the rear of the Base Station there are connections for the IRTD and Kaye References which can be used for Sensor Verification. Using the supplied cables connect the IRTD and bath to the appropriately marked connectors. The provides cables and connections are backward compatible to all Kaye baths, dry block and IRTD’s.
Chapter 2: Kaye ValProbe RT Hardware Base Station LED Indications The Base Station LED panel provides multi-colored status indications of item such as: Figure 33: Base Station Status Panel Figure 34: Base Station LED Indication Chart Kaye ValProbe RT User Manual 22
Chapter 2: Kaye ValProbe RT Hardware POWER LED: • GREEN indicates that power input is operational. • RED indicates an input power fail. BATTERY CHARGE LED: • GREEN indicates that battery has full capacity. • GREEN blinking indicates the battery is charging. • No indication that a battery is present or a battery issue. • RED blinking indicates that battery is at low capacity or a battery issue. STUDY STATUS LED: • GREEN indicates that a study is in progress.
Chapter 2: Kaye ValProbe RT Hardware Base Station Wakeup Magnet A powerful neodymium magnet is located behind the LED panel to the Kaye logo. The magnet can be used to wake up Loggers from sleep mode prior to connection and execution of a Qualification or Verification. Simply swipe the base of the Logger slowly over the Kaye logo. The Base Station LED’s flash along with a buzzer sound to state the Logger has been woken. The magnet is only used to awaken a Logger and cannot stop a Logger.
Chapter 2: Kaye ValProbe RT Hardware Pacemaker warning: Magnets inside the Base Station and Wakeup device may cause interference to near-by medical devices such as pacemakers, implanted heart defibrillators, etc. Do not carry or use the Base Station or Wakeup device near any medical devices and warn others who wear medical devices from getting close to the magnets. Kayetenna - Extended Antenna Cable The Base Station and Loggers are designed with a feature called Antenna diversity.
Chapter 2: Kaye ValProbe RT Hardware 2.5. ValProbe RT Console / Docking Station Figure 39: ValProbe RT Console The ValProbe RT system includes a portable, hardened dedicated validation Console running Windows 10 LTSC. The ValProbe RT Console is pre-loaded with a customized Kaye core-load designed to meet data integrity and 21 CFR Part regulatory requirements, while limiting applications to those only necessary for validation needs.
Chapter 2: Kaye ValProbe RT Hardware The ValProbe RT Console / Software provides an interface for the ValProbe RT system to configure and control the ValProbe RT Base Station and Loggers during the validation process. It also provides real-time display, data storage, and a powerful reporting tool for post analysis of Qualification data.
Chapter 3: ValProbe RT System Connections ValProbe RT System Connections The ValProbe RT system provides two options for connection from a Base Station to a Console /Docking Station; direct Ethernet connection via Static IP, or network Ethernet connection via DHCP. 3.1. Direct Ethernet Connection – Static IP Figure 40: Direct Connection The ValProbe RT Console and Base Station are factory configured for Direct Connection mode. The Base Station is programmed with a Static IP address of 192.168.99.50.
Chapter 3: ValProbe RT System Connections From the Select Base Station screen, press Discover BS in the upper right of the screen. Figure 42: Select Base Station Screen 7 If the Base Station was found and communication have been established, a blue tile signifying the Base Station appears with an IP Address 192.168.88.50. Note: If the Base Station’s blue tile does not appear with the IP 192.168.99.50 proceed to Section 3.3 for instructions to reset the Base Station and then return and repeat Steps 5 - 7.
Chapter 3: ValProbe RT System Connections 9 The BaseStation Setup screen details the settings stored in the Base Station. Settings include the Type of IP Address, related IP addresses, RF Channel settings, and Base Station settings. These settings are typically set once based on desired connectivity mode. Any changes to these fields are sent to the Base Station and stored in memory. a. Do not change the Type of IP Address or the IP Addresses if intending to use in Direct Connect mode. b.
Chapter 3: ValProbe RT System Connections 3.2. Network Ethernet Connection – DHCP Figure 44: Network Connection The ValProbe RT can also be configured to communicate using your company or private networks via DHCP. The ValProbe RT system is factory configure to utilize Direct Connection using a Static IP address of 192.168.99.55 for the Console and 192.168.99.50 for the Base Station.
Chapter 3: ValProbe RT System Connections 3. From the Base Station Setup window change the Type of IP Address from Static to DHCP and press Apply Changes. Figure 45: Change to DHCP 4. The changes are stored in the Base Station and the software tries, unsuccessfully, to rediscover the Base Station. The Base Station is not found because the Console IP settings need to be changed and an Ethernet cable needs to be connected from the Base Station to the network connected Console. 5.
Chapter 3: ValProbe RT System Connections e. Select Obtain an IP address automatically, then select OK and Close. Figure 48: Ethernet Properties f. Ensure that the Base Station and Console are connected to the Network via Ethernet cables. 6. Return to the ValProbe RT software’s Select Base Station screen. Figure 49: Select Base Station Select the Discover BS button. If the Network connection and setup were successful, the Base Station blue tile appears with the network assigned IP address.
Chapter 3: ValProbe RT System Connections 3.3. Resetting a Base Station Initiating a Factory Reset Press the Reset button displayed in Figure 41 for five seconds, note after one second there is an audible beep to indicate that Reset is pressed. When the Reset button is pressed for five seconds, two audible beeps sound indicating that a reset has occurred. Release the Reset button.
Chapter 4: Creating User Accounts Creating User Accounts 4.1. Introduction The Kaye ValProbe RT software includes a Kaye Default System Administrator account that allows you to log in to the Password Maintenance utility, following initial program installation, 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 system administration tasks.
Chapter 4: Creating User Accounts 4.2. Logging in as a Default System Administrator Before using the software, the computer automatically boots into the Kaye Operator windows account on startup. Inside the start menu, start the ValProbe RT software. Once you have started the ValProbe RT software, the Login screen appears as displayed below: Figure 50: Login Screen Enter “Kaye” in the User ID textbox. Note: “Kaye” is the default System Administrator user ID, and the User ID textbox is case sensitive.
Chapter 4: Creating User Accounts 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 built-in camera. After completing the system administrator user setup, the system logs you out. To proceed, open the software, and log back in with your new account information.
Chapter 4: Creating User Accounts 4.3. 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: It is recommended to create more than one System Administrator account if access to one is lost. To create a new System Administrator account: On the Main screen, press the Admin panel to open the Admin Settings window on the Preferences tab. From the Admin Settings window, press User Management.
Chapter 4: Creating User Accounts Enter a new System Administrator password in the Password textbox. The 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. Re-enter the password in the Confirm Password textbox and press OK. Note: Please record the user ID and password for future reference. Enter your designation and your Phone number and Email ID as contact details.
Chapter 4: Creating User Accounts Note: A user account is not active until the user changes the temporary password when logging in for the first time. Set the default Designation by pressing the entry on the drop-down list. Select any permissions to give to the user. Some examples of permissions include: • Creating setups • Running studies • Viewing or editing reports Press Save, and the username appears in the user list.
Chapter 4: Creating User Accounts Deleting and Disabling User Accounts Including active users, there are two additional states for a user: Disabled User A user can be disabled by an Administrator or automatically disabled after a certain amount of consecutive login failures (3-10) if enabled in Policies (see Setting Policies for details). A disabled user’s account is marked in red in the user list. The disabled state is set with the checkbox Disabled User Account in User Information.
Chapter 4: Creating User Accounts One Time Emergency Access Establishing more than one active Administrator account is good practice, if a system administrator is unavailable the system can still be maintained. If administrator access is no longer 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.
Chapter 4: Creating User Accounts 4.5. Setting Preferences Figure 53: Preferences Tab in the Admin Menu Once the initial ValProbe RT software installs with default system settings, you can change the settings inside the Preferences screen. The new settings become effective independently. • Company Name: Enter a company name to display in report headers. • Temperature: Use the drop-down to set the temperature units to Celsius or Fahrenheit.
Chapter 4: Creating User Accounts 4.6. Setting Policies Figure 54: Polices Tab Inside the Policies screen you can set policies that give users more flexibility on handling the password system, lethality, the D-Value, and calibration warning. The System Administrator can adjust: • Require minimum length password: Use the dropdown list to select how many characters are required for password length at a minimum.
Chapter 4: Creating User Accounts 4.7. Handling Data Files The ValProbe RT software permits synchronizing data across several consoles. The functionality is also used to backup, restore, and archive files. The synchronization requires a location for commonly used data. This can be any folder in the operating system that can be accessed for read/write operations, like a shared folder in the network, an external USB device, or a folder on the Kaye console itself.
Chapter 4: Creating User Accounts • Sync In The sync in function 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 drop-down selection.
Chapter 4: Creating User Accounts • Archive The Archive function works like 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 is moved. Like in Sync out the assets can be selected individually.
Chapter 4: Creating User Accounts • ValProbe RT Convert The ValProbe RT 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 ValProbe RT software.
Chapter 4: Creating User Accounts Figure 59: Windows – Mapping a Drive When syncing from the software to a mapped location using the ValProbe RT software: Browse to the mapped drive. It is may be required to open the drive through the file explorer and then entering windows credentials for access. If credentials are required to login to the mapped drive, they are automatically requested. Enter your credentials for accessing the drive.
Chapter 4: Creating User Accounts 4.8. Hardware Maintenance Figure 61: Hardware Maintenance BS Firmware Upgrade: Select this option to upgrade the Base Station firmware and press OK. Logger Firmware Upgrade: Select this option to upgrade the Logger firmware and press OK. Logger Battery Reset: Select this option to reset he Logger batter and press OK. 4.9. Online Help For online help, you need to swipe from the bottom or top edge for the app commands.
Chapter 5: Defining Equipment Defining Equipment Figure 62: Equipment Screen ValProbe RT software supports the organization of Kaye Validation Equipment. When accessed through the Main Menu, the Equipment hub displays Kaye equipment i.e. Base Stations, Loggers, IRTD as tiles. The following functionality is offered: An all used Kaye Equipment database, that is identified by serial number, manufacturing calibration information, and an optional picture.
Chapter 5: Defining Equipment 5.1. Adding New Equipment To add new Kaye equipment to the ValProbe RT system, press the Plus (+) icon on Equipment Hub screen. The New Equipment screen automatically opens (displayed below). Figure 63: New Equipment Screen Enter details for each new piece of equipment separately. Use the textboxes and drop-down menus to enter the following: • Serial No.
Chapter 5: Defining Equipment 5.2. The Equipment Hub To review what equipment has been added by type, select the tile on the Equipment Screen to open the Equipment Hub screen. The Equipment Hub screen lists all added equipment for that particular type. The following information is displayed in each equipment tile, • Serial No. • Type.
Chapter 5: Defining Equipment 5.3. Checking Details for Existing Equipment To review the details for equipment added into the software, from the Equipment Hub screen select the equipment tile to open the Equipment Details screen. Figure 64: Equipment Details Screen On the left side of the screen, the following equipment details are listed. • An Image • Serial No.
Chapter 5: Defining Equipment 5.4. Calibration Reminder The calibration date listed in the calibration reminder ensures that the operator does not miss calibration due dates. To use the calibration reminder, you must activate and set the calibration reminder timeframe in the Policies, see page 44.
Chapter 6: Defining Assets Defining Assets The ValProbe RT includes an intuitive Asset Centric Data Management concept (patent pending) which allows you to store and access data faster and more efficiently. Each individual process that you validate whether a heat bath or sterilizer etc., can be set up 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.
Chapter 6: Defining Assets 6.1. Asset Details Screen To learn more about an asset, select that tile asset’s tile on the Assets screen, the Asset Details screen (shown below) opens: Figure 66: Asset Details In the upper left, the asset type and name is listed as the Title.
Chapter 6: Defining Assets The New (+) button creates a new setup, and it is also possible to copy existing setups from other assets as templates. Pressing Copy opens a list of all available setups on the console. The population of this list may take some time, dependent on the number of assets and setups. Assets are listed by their names and setup names, number of sensors, comments, and last modification date. Using the last column, you can select setups to copy to the asset.
Chapter 6: Defining Assets The existing asset can also serve as a template for a new asset. Use the blue C button to open the 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 67: Copy Asset Screen 6.2. New Asset Screen To enter a new asset into the ValProbe RT system, go to the Asset Hub screen and press the Plus (+) icon. The New Asset screen opens.
Chapter 6: Defining Assets • The type of asset: Any new type definition will be available in the drop-down in the future. Please be careful as also test types or wrong spelled types will be available in the drop-down. This field is mandatory and required for sorting. • Manufacturer: Specify the manufacturers name of the asset. This field is mandatory and required for sorting. • Location: Specify the location of the asset. This field is mandatory and required for sorting.
Chapter 7: Defining Study Setups Defining Study Setups Before you can run a qualification study, you must use the ValProbe RT software to create or modify a setup. A setup defines everything required to 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). The setup is accessed from the Asset Details screen, through the Setup pane.
Chapter 7: Defining Study Setups 7.1. Create a Setup File A setup defines everything required to calibrate sensors and run a qualification study for a specific asset. Setup files are created in the Setup screens. To create setups, permissions must be assigned by your System Administrator. Figure 69: The Setup Hub Screen To create a setup file: From the Asset Details screen, press Setups. In the Setup Pane Hub, press New to enter the Study Details screen.
Chapter 7: Defining Study Setups 7.3. Define Setup Screen On the Asset Details Screen Setup Hub, press New to open Define Setup. Figure 70: Define Setup Screen On this screen, you define the setup for a study. Use the textboxes or drop-down lists to enter: • Setup Name • No (number) of Max Sensors • Asset ID # • SOP (Standard Operating Procedure) Protocol Number • Load Description • Comments Note: The Setup name and number of sensors fields are mandatory.
Chapter 7: Defining Study Setups 7.4. Sensors Configuration Screen From the Asset Details screen, press Sensors Configuration to open the Sensors Configuration screen. Figure 71: Sensors Configuration Screen The Sensors Configuration screen graphically represents all connected sensors. The sensors are labeled based on their type. Once you add sensors, they appear as blue tiles, to indicate that they have not been selected.
Chapter 7: Defining Study Setups Figure 73: Sensor Description Click the Description button to open the Sensors Description screen. On this screen all sensors are listed in a table with the information entered in the configuring sensors section. If desired, click a sensor and enter a description in the Description textbox and click OK to save the description or Close to cancel. To return to the Sensors Configuration screen click the red X in the upper left corner.
Chapter 7: Defining Study Setups 7.6. Assigning Sensors to Groups Figure 74: Group Sensors Screen On the Group Sensors screen, Loggers 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 Group Sensors. The Group Sensors screen displays a scrollable listing of existing groups, as well as the New Group button.
Chapter 7: Defining Study Setups Figure 75: Wiring Overlay Diagram Using the wiring diagram, you can define up to five pictures as background for placing the sensor positions. After selecting a picture frame on the right side, a picture can be loaded from a disk or taken with the built-in camera. The Trash icon can be used to delete pictures. Note: If opening the camera, ensure that the software can access the camera. The picture can be taken by pressing the camera icon through the device camera.
Chapter 7: Defining Study Setups 7.7. Specifying Group Calculations Figure 76: Calculations Once you have defined sensors and assigned them to one or more groups, the next step is to specify calculations to be performed on the group of sensors during the qualification study. Calculations include, lethality, saturation pressure of steam, and saturation temperature of steam calculations. The Statistical Calculations are all preselected by default and are calculated.
Chapter 7: Defining Study Setups 7.8. Specifying Qualification Study Conditions Figure 77: Qualification Parameters 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. Data storage options - the rates at which data is written to the memory of the Logger during a qualification run.
Chapter 7: Defining Study Setups 7.9. Reviewing and Changing a Setup Figure 78: Setup Review Screen After pressing Review, the Review screen opens, listing all the pertinent details about the setup you have just created. The Review screen provides following actions: • Copy as New Setup —copy the current setup as a new setup and save it under a different name. • Create Setup Report — creates a setup report as pdf file for saving and printing.
Chapter 8: Viewing Live Data Viewing Live Data Once you have entered a setup into your ValProbe RT, you can monitor live data or qualification study progress on the Console. 8.1. Selecting a ValProbe RT From the Main Menu, press the Discover tile, located under “Hardware”, to open the Select Base Station window. Figure 79: Main Menu with Hardware Discover Tile Pressing Discover BS searches the connected Networks (LAN or Wi-Fi) for available Base Stations.
Chapter 8: Viewing Live Data Note: If a Base Station is not in the same IP segment the discover function will not be unable to find it. Nonetheless, if the TCPIP address of the Base Station is known and the connection is not blocked, a connection can be established by entering the IP address and adding the Base Station to the available devices manually. Select the tile for the Base Station you need to use, and then press Connect to establish the connection between the Console and the Base Station.
Chapter 8: Viewing Live Data 8.3. Live Data During Qualification In the Live Monitoring mode, no study is running and the data collection structure (sensor and groups definition) are following the last transferred setup (to transfer a setup you need to start a study). If the ValProbe RT is in monitoring status, you can switch between List and Graph View to see live data.
Chapter 8: Viewing Live Data The header always displays the name of the active setup and the serial number of the connected ValProbe RT. For detailed information about the system (IP, software, and firmware versions), swipe up to display the command charms, and press About. For Windows 10, swipe down from the top right-side of the screen to open commands on the lower left-side of the screen and press About.
Chapter 8: Viewing Live Data List View The List view displays the live readings of sensor values of a group in a table. The first column displays the sensor number. The second column displays the label as assigned in the setup, followed by the sensor value in the third column. The forth column displays the battery level of the sensor as a percentage. RF link status is listed in the fifth column.
Chapter 8: Viewing Live Data Graph View Pressing Graph View switches to real-time graphing of senor readings. The sensors are organized in groups defined in the setup. The different groups can be selected by pressing the buttons above the graph. The Graph View is controlled with the buttons below the Graph. Zoom into the data via the touch screen control. For easier operation, it is possible to zoom only X- or Y-axis by selection.
Chapter 8: Viewing Live Data Historical Data View The ValProbe RT 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 anytime during a study. When connecting to a ValProbe RT that runs a qualification study, when switching to the Graph View, a progress indicator represents the download of the data to the console.
Chapter 8: Viewing Live Data Figure 86: Historical Data in Graph View Pressing List view switches back to a table view of sensor readings.
Chapter 8: Viewing Live Data Layout View The Layout View can be used to see an intuitive distribution of live readings data. The background picture and the sensor positions are defined in the Group configuration in the setup. You can take pictures using the built-in camera or add an existing picture and position the sensor tags via drag & drop. The real-time values are displayed inside the tags.
Chapter 8: Viewing Live Data 8.4. Live Data During Verification If the ValProbe RT is in Verification, the Verification List/Graph View screen displays a table or graph for the active verification setpoint sorted by the sensor input. On the right side of the screen, the set points are marked, when a set point is reached the set point is green. Below the set points the following is displayed: Setpoint: The setpoint Celsius temperature to reach.
Chapter 8: Viewing Live Data Figure 89: Calibration in Graph View Screen Figure 90: Verification Parameter Screen By pressing Initiate Verification, the Verification parameters as defined in the setup can be reviewed, it is possible to edit the parameters before the start of the verification.
Chapter 8: Viewing Live Data 8.5. 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 91: Hardware Screen A Device Not Found status (gray line) indicates that the hardware is not communicating and may not be connected properly.
Chapter 8: Viewing Live Data 8.6. Select a Temperature Standard If you have two IRTDs connected to the Kaye ValProbe RT, IRTD on the upper port is used as temperature standard. The IRTD port displays in the hardware screen or used to power a pressure transducer with a special cable. Note: For verification studies, only the upper port is recognized. 8.7.
Chapter 9: Qualification Study Qualification Study 9.1. Introduction Once the setup is defined and loaded into the Kaye ValProbe RT and the sensors, if necessary, have gone through a Verification, everything is ready to run a qualification study. The Kaye ValProbe RT uses the qualification parameters defined in the setup to perform the qualification study.
Chapter 9: Qualification Study 9.2. Load a Setup Before the start of the qualification process, ensure that the defined setup for this asset is loaded from the Console into the Kaye ValProbe RT: Select the predefined setup file for this asset. Load the setup into the Kaye ValProbe RT. Select a Setup File If the setup is not yet created, please see Chapter 7 for instructions on how to create a setup.
Chapter 9: Qualification Study 9.3. Viewing the Active Qualification Study To start a study, press Start Qual or use the automatic start condition defined in the setup (if Start Qual is not available) and enter User Credentials. Figure 93: List View - Real-Time Readings During the qualification study, real-time sensor readings and calculations for each group defined in the setup are displayed.
Chapter 9: Qualification Study 9.4. Graph Real-Time Sensor Readings and Calculations Figure 94: Graphing Sensor Readings During qualification, data samples are displayed per the display rate. To graph real-time sensor readings and calculations: • Press Graph View, to display the Graphs screen. • All the available Groups in that setup are displayed, when pressing the button for each group, the corresponding graph is displayed.
Chapter 10: Sensor Verification Sensor Verification 10.1. Introduction and Overview With the ValProbe RT system, you can verify sensors at up to six different temperature setpoints for Pressure/Temperature Loggers, each sensor type must be verified independently. The ValProbe RT uses the parameters defined in your Verification setup to perform sensor verification.
Chapter 10: Sensor Verification Defining Verification Strategy and Criteria The Kaye ValProbe RT software allows you to verify Logger accuracy at up to six set points. Verifications can be used for multiple purposes. Kaye recommends a quarterly verification to ensure the Loggers are still within their specification of 0.
Chapter 10: Sensor Verification Table 6: Recommended Temperature Baths Model Bath Uncertainty IRTD Uncertainty Maximum Total Uncertainty CTR-25 (-25°C to 140°C) – Liquid 0.020°C 0.025°C 0.045°C CTR-40 (-40°C to 150°C) – Liquid 0.010°C 0.025°C 0.035°C CTR-80 (-80°C to 30°C) – Liquid 0.012°C 0.025°C 0.037°C LTR-150 (-30°C to 150°C) – Liquid/Dry 0.10°C 0.025°C 0.125°C Note: Dry Blocks cannot be utilized for Verification to manufacturers specifications (0.
Chapter 10: Sensor Verification 10.2. Creating a Verification Setup Before you can run a verification process, you must create a Verification Setup. To create the Verification Setup, navigate to the Main screen and then select Equipment. and enter your ID and Password. Figure 96: Select the Equipment Tile Verifications are configured and initiated via the Equipment tile. Select Initiate Verification to navigate to the Verification setup screen.
Chapter 10: Sensor Verification Choose the Temperature verification type on the Select Verification Type window.
Chapter 10: Sensor Verification 10.3. Loading a Verification Setup Before you begin the Verification process, you must load your setup into the ValProbe RT loggers. A Kaye IRTD must be used to execute a Verification study. Please connect it and the Temperature bath / Drywell to the Base Station connectors on the rear of of the Base Station. Each connector is marked with the appropriate icon. Utilize the supplied cables for the connection. Power up the connected bath.
Chapter 10: Sensor Verification If no Base Stations are displayed check your connections and settings: • If using direct connection using Fixed IP ensure the supplied ethernet cable is connected directly from the Base Station to the Console docking • If the System is going to be on the network (DHCP) ensure the Console and Base Station and connected via ethernet cables to the network ethernet connections. Select the desired Base Station tile, then press Connect. Figure 103: Select Base Station 10.4.
Chapter 10: Sensor Verification For additional information on a Logger, select it and then press the Logger Details button. To proceed with the Verification study, click Sensor Information. Figure 105: Loggers Listed The Sensor Information screen will allow you to do a last review of the loggers about to be programmed. Ensure all Loggers selected are listed and then press Program Loggers.
Chapter 10: Sensor Verification Figure 108: Verification Study Screens Note: It is important to ensure live data is displayed from the Logger sensors and IRTD before starting a Verification. This guarantees a good RF connection between Loggers and base station and so you can be sure that each logger receives the Start Verification command. If using a Dry Block reference, place the logger sensors into the Dry Block and then proceed to next step to Start.
Chapter 10: Sensor Verification During the verification process, live data can be displayed in two ways, in a Graph view and a List view. If the list exceeds the screen size, you can scroll vertically through the remaining data. On the graph, temperature appears on the Y-axis, while the highlighted X-axis displays the stabilized IRTD temperature. All sample points that lie within the deviation specified are displayed as dots along with the label and the temperature point of the sensor.
Chapter 10: Sensor Verification Figure 111: Temperature Verification List View / Green Read Button Figure 112 below, displays the readout process of the loggers. Figure 112: Read Loggers Screen On the Verification Results screen perform the following • Press Save Study to save the Study to the Console • Press Update Loggers to update the last Verification date stored in the Logger firmware.
Chapter 10: Sensor Verification The Verification Results screen will display the Pass / Fail analysis results of the Verification for each sensor. You can select the setpoints to view the results for each setpoint. Additional Verification report options: • Check detailed sensor readings and IRTD readings using the Sensor Readings button.
Chapter 11: Qualification Reports Qualification Reports 11.1. Reports Overview The Kaye ValProbe RT 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. 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.
Chapter 11: Qualification Reports Setup Report The Setup Report documents all details and configuration of a Setup.
Chapter 11: Qualification Reports 11.2. Qualification Detailed Report Detailed Reports are created from the raw encrypted Qualification files and provide the complete details of all sensor measurements and calculations (Statistical, Lethality, Steam Saturation) during a Qualification study. The content of the Qualification file is based on the parameters defined in the Setup.
Chapter 11: Qualification Reports 11.3. Qualification Summary Report Summary Reports are created from raw encrypted Qualification files and as titled, for each Group provide a summary by cycle of all sensor measurements during the Qualification study. All calculations performed by the Summary report are set by the Storage rate as defined in the Setup. The main report header provides the same traceability information for the study as defined in the Detailed report.
Chapter 11: Qualification Reports 11.4. Graph Reports Graphs reports offer a flexible tool to analyze the data from the raw encrypted Qualification file and create numerous graph reports. The Graphs reports and the calculations and Groups they utilize are based on the Sample rate and other parameters defined in the Setup. Figure 118: Graph Report Screen The Graph report defaults to displaying All Temp Sensors for the duration of the Qualification study.
Chapter 11: Qualification Reports Lethality The Accumulated Lethality graph displays lethality totals for each included sensors at each timestamp programmed or defined to calculate lethality. Alternatively, the lethality accumulation can be displayed as a bar graph. Sat P The Saturation Pressure calculation is only available if the study includes at least one temperature sensor and pressure sensors. The Saturation Pressure vs.
Chapter 11: Qualification Reports The first vertical red line indicates the time the first Temperature sensor reached the lethality base temperature (Tb). The lethality base temperature is marked by the horizontal red line. The second vertical line is either 15 or 30 seconds after the first Temperature sensor reached the base temperature, depending on the time period you select.
Chapter 11: Qualification Reports Edit Sensors Press Edit Sensors to choose the sensors to include in each Graph Report. Selections made on the Graph Report screen are unique to the Graph Report and do not affect the contents of the Setup, Qualification Detailed, or Qualification Summary Reports. Options for choosing sensor colors and line thickness are available. Important: Excluded sensors from any of the graph reports are not included in the calculation graphs.
Chapter 11: Qualification Reports 11.5. Audit Trail Report To meet 21 CFR Part 11 and Data Integrity requirements, the ValProbe RT 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. The purpose of the Audit Trail is to give users the ability to review and print the history of actions affecting Gxp files and events.
Chapter 11: Qualification Reports There are two ways to generate Audit Trail Reports, first, the user can select the Audit Trail and the date range of the Qualification study to provide a quick method of generating an Audit Trail tied to a Qualification Study. Figure 120: Audit Trail For a more detailed review and report capability the user can go to Audit from the Main Menu. There the user can do a more detailed search over the complete history using the filters in each column.
Chapter 11: Qualification Reports 11.6. Spreadsheet Report The Spreadsheet Report generates a CSV file which can then be used for those wishing to import their data into Excel for further analysis or graphing. The file is automatically divided into numerous tabs which provide detail Qualification data.
Chapter 11: Qualification Reports 11.7. Pass/Fail Report Pass / Fail Report Overview The Pass / Fail Criteria report eliminates hours of manual or spreadsheet based analysis, by providing an automated report, which analyzes Qualification raw data and provides a report detailing whether the Qualification data successfully passed or failed to meet user defined criteria.
Chapter 11: Qualification Reports Figure 122: Pass/ Fail Criteria – Template Definition Screen In the configuration of the Pass/Fail Report the User can select which Cycle from the Qual File to utilize for the analysis. Once the Cycle is defined, the user can delay the Cycle Pass/ Fail evaluation by a defined number of samples. The number of samples times the sampling rate defines the delay time. This delay allows the cycle to stabilize or equilibrate prior to evaluation.
Chapter 11: Qualification Reports For Time at/below Process Temperature per Sensor, the system accumulates time for each sample interval A1/A2, A2/A3...A5/B1) only if both, the data points at the beginning and end of the sample interval are beyond (above/at/below) the defined condition. 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.
Chapter 11: Qualification Reports Figure 124: Template to Group Screen Users can return to and select different templates for different groups (i.e. Distribution, Penetration or different chambers in one study. Pass / Fail Criteria Calculations A User can select up to 16 commonly utilized and regulatory driven criteria to customize their reports based on their specific needs.
Chapter 11: Qualification Reports Temperature at / Below Process Temp per Sensor: The Time at/below Process Temperature per Sensor calculates for each sensor the total time for each sensor at or below the process temperature during the cycle. The criteria fields allow the definition of the maximum time, the minimum time or both. To meet the minimum criteria all sensor calculated times must be equal to or above the minimum criteria.
Chapter 11: Qualification Reports Note: This is the only criterion that is not using the cycle defined in the criteria template, but the definition of the lethality calculation set in the Edit Calculations screen. Only lethality per cycle or per Edit Calculations can be calculated within the same report. The selection of one automatically deselects the other one.
Chapter 11: Qualification Reports Equilibrium Duration: The Equilibrium Duration calculates the time in seconds from when the defined Reference Sensor in the Group reaches the Process Temperature until the last sensor in the Group reaches the Process Temperature. The dropdown menu allows selection of the reference sensor. The Equilibrium Duration field is only definable if the study has a one second sampling rate. The criterion value is the Maximum time in seconds allowed.
Chapter 11: Qualification Reports Pass / Fail Criteria Report Once the Pass/ Fail Criteria template has been selected or defined, the User can then define which groups from the Qualification file they wish included in the Pass / Fail Report. The Pass/Fail Criteria Report contains two sections: Criteria Evaluation and Sensor Detail. 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”.
Chapter 11: Qualification Reports Figure 126: 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. Amphenol is not liable for any damages resulting from reliance on the pass/fail criteria included in the software in making product release decisions.
Chapter 11: Qualification Reports 11.8. Generating Qualification Reports Before selecting a report type, the ValProbe RT software permits the user one last opportunity to verify or edit parameters such as: • Start / Stop conditions (Marking Cycles) • Sensor groupings • Sensor calculations Using these parameters, any errors or omissions can be corrected before generation of the report. These changes do not affect the raw sensor data, or storage rate of the Qualification file.
Chapter 11: Qualification Reports The existing Qual and Exposure times and duration are listed in the table above the graph. To edit any of the times press the pen icon for the selected time to change. A pop-up box will allow selection for Time Marker or Events to change the selected cycle time. Figure 128: Mark Cycles Screen Selecting Time /Marker displays a line marker.
Chapter 11: Qualification Reports Figure 130: Mark Cycles Using Events If creating a new event, the user can specify a message which appears in the Detailed 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 > 100.0 C). When all details are entered press the Checkmark and the selected time will be marked When completed with any edits to the Qual / Exposure times press Define Additional Cycles.
Chapter 11: Qualification Reports Figure 132: Define Additional Cycles Screen To add additional cycles, press the button on the Cycles screen. A pop-up appears with a prompt on how to mark the additional cycle by Time / Marker or Event. The functionality for performing these tasks are the same as for the Qual / Exposure screen. When all additional cycles are added, press the Report Parameters ribbon at the top of the screen to move to the next step of the reporting process.
Chapter 11: Qualification Reports Figure 134: Edit Groups screen The Edit Groups screen includes the following options: • Add New Group – press New Group and enter a name, select sensors, and a title. • Move Sensors between Groups –press • Delete Groups – select a Group Name and press Delete to delete individual sensors from a group. • Edit Groups Header – select the Group name and press the Edit Group Header arrow.
Chapter 11: Qualification Reports • If the MKT calculation is desired the value of Heat activation can be set. Note: Changes to lethality calculations are permitted only if given permission inside preferences. Changes to D-Value can be permitted inside policies. Lethality and Time of Sterilization New European regulation have placed and emphasis on ensuring you have proper steam quality when calculating lethality.
Chapter 11: Qualification Reports Report Selection On the Report Selection screen, you can select between Standard text reports or Graph reports. Figure 137: Report Selection Screen Graph Reports: The Graph Reports allows the user to report the Qualification data in graphical format. See section (10.5 Graph Reports) for a detailed explanation of the options and tools available for graphing. Standard Reports: The Standard Reports screen allows the user to select which reports to generate.
Chapter 11: Qualification Reports Prior to generating the selected reports ensure the Report Content for each selected report as well as the Header/Footer and Print Rate are defined. Report Content: The Report Content for each report defines which groups and or calculation are to be included in the reports. Setup – Allows selection if overlay diagram is included in report Figure 139: Setup Report Content Screen Summary – Allows selection of groups included and Lethality or MKT calculation.
Chapter 11: Qualification Reports Header / Footer: The Header Footer allows customization that apply to all selected reports. • User Comments can be added to the first and/or last page of the report. • Header Footer Titles can be customized to be specific company needs. • Footer signature lines can be selected to appear of first, last or all pages. • System Messages can be selected or deselected to appear in reports.
Chapter 11: Qualification Reports 11.9. Edit Parameters Screen Figure 146: Edit Parameters Screen Inside the Edit Parameters screen the User can make any necessary changes to Groups and or Calculations prior to reporting. Any changes to Groups or Calculations are listed in the report. If groups and calculations are configured correctly in the study setup, there is no need to make changes. Press the Next arrow to continue to the Report Selection screen.
Chapter 11: Qualification Reports 11.10. Report Selection On the Report Selection screen, you can select the type of Qualification report to generate. Figure 147: Report Selection Screen Standard Reports: The Detailed and Summary report interface screens are used for generation of table format reports from qualification studies to pdf files.
Chapter 11: Qualification Reports 11.11. Grouping Sensors Figure 148: Group Sensors Screen To assign sensors to groups: Select individual sensors to select them for a group. These sensors appear blue with an orange checkbox. Press New Group, a group name textbox appears above the selected screens and enter a name and press Save to save the group.
Chapter 11: Qualification Reports Figure 149: Report Options Screen Press Generate Report to generate the respective report type or customize report options. Content for the selected report can be customized via the Report Content button. A table opens, listing all available groups and valid calculations for the sensors type of the group. Lethality and MKT calculations cannot be selected for one single report.
Chapter 11: Qualification Reports Note: For a new group added in “Edit Groups” to be included in the Detailed/Summary Report, it is required to select the corresponding groups and its calculations in Report Contents. To customize the header and footer report structure, select Header/Footer. Use the Comments textboxes to enter any free text to display on the first and last page of the report. The textboxes below “Header Footer Text” can be used to customize the header and footer of the report.
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Appendix A. Specifications Appendix A. Specifications A.1 Kaye ValProbe RT System A.1.1 List of Certified Countries USA, Canada, European Union, and Puerto Rico. A.1.2 Regulatory Compliance CE, FCC and safety listed by Eurofins MET Labs, USA. A.1.3 RF System Operating Frequency and Modulation 2.4 GHz unlicensed ISM band with modulation O-QPSK (IEEE 802.15.4 complaint). A.1.4 RF Channels 15 RF channels (11th to 25th channels) - 2405 to 2475 MHz. A.1.
Appendix A. Specifications A.2 Kaye ValProbe RT Base Station A.2.1 Input Power and Adaptor Ratings AC-DC adaptor input 100 to 240Vac 50/60Hz and output 12Vdc, 4A. A.2.2 Installation Category Pollution Degree 2, indoor use and maximum working altitude up to 2,000 meters. A.2.3 Class Overvoltage Category and Electrical Safety Protection Overvoltage category II and Electrical safety protection Class II. A.2.4 Input DC Power On/Off Switch Switch to turn on/off DC input power to Base Station. A.2.
Appendix A. Specifications A.2.13 Enclosure Material Premium ABS plastic with FDA grade and conforming to safety UL 94-HB flammability rating. A.2.14 Environmental Ratings Operating temperature: 0 to 50°C. Relative Humidity RH%: 0 to 90% RH, non-condensing. Storage temperature: -40 to 60°C. A.3 Kaye ValProbe RT Logger A.3.1 Installation Category Pollution Degree 2, indoor, and outdoor use, maximum working altitude up to 2,000 meters. A.3.
Appendix A. Specifications A.3.8 Housing Material Pharma grade PEEK (Polyetheretherketone) material housing and conforming to safety UL 94-V-0 flammability rating. A.3.9 Logger Base Dimensions Height 48mm (1.9”) / Diameter 36 mm (1.4”). A.3.10 Ingress Protection IP68 compliant. A.3.11 Insulating Canister X2545 Size 149mm (5.87”) x 45mm (1.75”) (Length x diameter), weight 330grams (0.73 lb). A.3.12 Battery Field replaceable 3.6VDC ½ AA Lithium Thionyl Chloride primary battery. A.3.
Appendix A. Specifications Bendable Loggers: till 400°C (on request – please contact factory). A.4.5 Sensor Lengths Rigid 1.5, 3, 6 and 9” inches. Bendable 12, 24 and 36” inches. Flexible 40” inches. Please contact factory for special lengths. A.5 Kaye ValProbe RT Std Temperature Logger A.5.1 Measurement Accuracy ±0.1°C from -40 to 140°C ±0.25°C from 140 to 400°C for bendable models A.5.2 Body Environmental ratings: Temperature: -40 to 140°C. Temperature: -40 to 360°C with canister model.
Appendix B. Regulatory Compliance and Agency Approvals Appendix B. Regulatory Compliance and Agency Approvals Regulatory model numbers: Kaye ValProbe RT Base Station Regulatory model number - RF3060 Kaye ValProbe RT Loggers Regulatory model number - RF3050 B.1 Electrical Safety Approvals: Kaye ValProbe RT Product Electrical safety is certified by MET Laboratories, Inc. USA and product is complaint to IECEE CB-scheme for access into international market. B.1.
Appendix B. Regulatory Compliance and Agency Approvals B.1.4 IEC and CB Scheme Certification IEC 61010-1: Third Edition Safety requirements for electrical equipment for measurement, control and laboratory use; Part 1: general requirements. IEC 61010-2-030: 2010, First Edition, Safety requirements for electrical equipment for measurement, control and laboratory use; Part 2-30: Particular requirements for equipment having testing or measurement circuits. B.2 Radio and EMC Certification Approvals: B.2.
Appendix B. Regulatory Compliance and Agency Approvals B.2.2 European Radio and EMC Certification Approvals: Kaye ValProbe RT is certified to Europe Radio and EMC standards listed below: ETSI EN 300 328 V2.1.1:2016-11 Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques - RED (2014/53/EU). ETSI EN 301 489-1 V2.2.
Appendix B. Regulatory Compliance and Agency Approvals B.5 Transportation Regulations Batteries: Base Station shipping package has Lithium ion rechargeable batteries and Logger shipping package has Lithium primary battery. Both shipping packages are classified as nonrestricted (can be shipped by common carrier without special requirements). Batteries should be separated from each other during shipment to prevent shorting.
Appendix B. Regulatory Compliance and Agency Approvals L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation, Sciences et Développement économique Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes : 1.L’appareil ne doit pas produire de brouillage; 2.L’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement.
Appendix B. Regulatory Compliance and Agency Approvals Product Certification Labels B.9.1 Kaye ValProbe RT Base Station Label B.9.
Appendix C. Environnemental Compliance Appendix C. Environnemental Compliance This appendix contains information on the following topics: • WEEE Directive (see Section C.1 on page 146) • Battery Disposal (see Section C.2 on page 146) C.1 Waste Electrical and Electronic Equipment (WEEE) Directive Amphenol Thermometrics, Inc. is a participant in Europe’s Waste Electrical and Electronic Equipment (WEEE) take-back initiative, directive 2012/19/EU.
Appendix C. Environnemental Compliance C.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% C.2.
Appendix D. Warranty and Returns: Appendix D. Warranty and Returns: Each instrument manufactured by Amphenol Advanced Sensors. is warranted to be free from defects in material and workmanship. Liability under this warranty is limited to restoring the instrument to normal operation or replacing the instrument, at the sole discretion of Amphenol Advanced Sensors. Fuses and batteries are specifically excluded from any liability. This warranty is effective from the date of delivery to the original purchaser.
Appendix E. Service Information Appendix E. Service Information We operate a global network of service centers and a field service organization to provide customer support for repair, returns, calibrations, technical support, evaluation and spare parts. Americas Europe China Amphenol Advanced Sensors Amphenol Advanced Sensors Germany Amphenol (Changzhou) Connector Systems 967 Windfall Rd GmbH Co., Ltd. St. Mary's PA 15857 Sinsheimerstr.
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Index A Active Qualification Study ............................................................................................................................ 86 Assets Detail ....................................................................................................................................................... 56 Hub .......................................................................................................................................................... 56 New .............
Index R Real-Time Graph ...................................................................................................................................................... 87 S Setup Create ..................................................................................................................................................... 62 Stability Calculate .................................................................................................................................................
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www.kayeinstruments.com © 2020 Amphenol Thermometrics, Inc. All rights reserved. Technical content subject to change without notice. MXXX Rev. 1.
