Kaye ValProbe RT User manual

Validation
Kaye ValProbe®RT
User Manual
M5630-EN Rev. D
October 2022

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Kaye ValProbe®RT
Process Monitoring and Validation System
User Manual
M5630-EN Rev. D
October 2022
Copyright © 2022 Amphenol Thermometrics, Inc.
967 Windfall Road
St. Marys, PA 15857-3333, USA
Web: www.kayeinstruments.com

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Contents
ValProbe RT User Manual i
Chapter 1. Kaye ValProbe®RT System ................................................................................... 2
1.1. Introduction....................................................................................................................... 2
1.2. Operational Description.................................................................................................... 3
1.3. Unpacking......................................................................................................................... 4
1.4. Safety Information ............................................................................................................ 5
Chapter 2. Kaye ValProbe RT Hardware ................................................................................. 6
2.1. Kaye ValProbe RT Loggers ............................................................................................. 6
Temperature RT Loggers ......................................................................................... 8
Pressure/Temperature Loggers.............................................................................. 12
Humidity Loggers.................................................................................................... 13
Insulating Canister for High Temperatures ............................................................ 14
Inserting a Logger into an Insulating Canister........................................................ 14
Measurement Range and Accuracy ....................................................................... 16
2.2. Data Collection............................................................................................................... 16
2.3. Logger Battery................................................................................................................ 17
Battery Estimator .................................................................................................... 18
Battery Replacement .............................................................................................. 19
2.4. Kaye ValProbe RT Base Station.................................................................................... 23
Base Station Overview ........................................................................................... 23
Base Station IRTD / Bath Connections .................................................................. 24
Base Station Battery Backup.................................................................................. 24
Base Station LED Indications ................................................................................. 25
Base Station Wakeup Magnet................................................................................ 28
Wakeup Device....................................................................................................... 28
Kayetenna - Extended Antenna Cable................................................................... 30
2.5. ValProbe RT Console / Docking Station........................................................................ 30
Chapter 3. ValProbe RT System Connections ..................................................................... 32
3.1. Direct Ethernet Connection – Static IP .......................................................................... 32

Contents
ValProbe RT User Manual ii
3.2. Network Ethernet Connection – DHCP.......................................................................... 35
3.3. Resetting a Base Station................................................................................................ 37
Initiating a Factory Reset........................................................................................ 37
Chapter 4. Initial ValProbe RT Software Setup .................................................................... 38
4.1. Introduction..................................................................................................................... 38
4.2. Initial Log in as a Default System Administrator............................................................ 39
Setting Up Initial Administrator using Local Security and Policies......................... 40
Setting Up Initial Administrator using Active Director Security and Policies.......... 42
Adding / Managing User Accounts – Local Security.............................................. 45
Deleting and Disabling Local Security User Accounts........................................... 47
Local Security - One Time Emergency Access...................................................... 48
Adding / Managing User Accounts – Active Directory™* ...................................... 48
4.3. Setting Preferences........................................................................................................ 50
4.4. Hardware Maintenance.................................................................................................. 51
4.5. Online Help..................................................................................................................... 54
Chapter 5. File Management................................................................................................... 55
5.1. Overview......................................................................................................................... 55
Sync Out ................................................................................................................. 56
Sync In .................................................................................................................... 57
Archive .................................................................................................................... 57
ValProbe RT Convert.............................................................................................. 58
5.2. Using Mapped Drives for Sync Functions ..................................................................... 58
Chapter 6. Equipment.............................................................................................................. 60
6.1. Equipment Assets .......................................................................................................... 60
Manually Adding Equipment Assets....................................................................... 61
Equipment Contents ............................................................................................... 61
6.2. Calibration Reminder ..................................................................................................... 62
Chapter 7. Defining Assets..................................................................................................... 63

Contents
ValProbe RT User Manual iii
7.1. Overview......................................................................................................................... 63
7.2. Asset Details Screen...................................................................................................... 64
7.3. Creating A New Asset.................................................................................................... 69
Chapter 8. Defining Study Setups ......................................................................................... 70
8.1. Initiating a New Setup .................................................................................................... 70
8.2. Define Setup Screen...................................................................................................... 71
8.3. Sensors Configuration Screen....................................................................................... 72
8.4. Understanding Groups................................................................................................... 74
8.5. Assigning Sensors to Groups ........................................................................................ 75
8.6. Specifying Calculations.................................................................................................. 77
8.7. Specifying Qualification Parameters.............................................................................. 79
8.8. Reviewing and Saving a Setup...................................................................................... 80
8.9. Modify an Existing Setup................................................................................................ 81
Chapter 9. Qualification Study............................................................................................... 82
9.1. Overview......................................................................................................................... 82
9.2. Initiating a Qualification Study........................................................................................ 83
Select a Setup File.................................................................................................. 83
Connecting to Base Station.................................................................................... 84
Selecting and Connecting to Loggers .................................................................... 84
Re-reading Loggers ................................................................................................ 86
Battery Estimate...................................................................................................... 86
Mapping Sensors.................................................................................................... 87
9.1. Auto Mapping Sensors................................................................................................... 88
9.1. Real Time Off Study....................................................................................................... 89
9.2. Program Loggers............................................................................................................ 92
9.3. Qualification Study Start / Stop Conditions.................................................................... 93
9.4. Viewing Qualification Real-Time Displays..................................................................... 94
List View.................................................................................................................. 95

Contents
ValProbe RT User Manual iv
Graph View ............................................................................................................. 95
Layout View............................................................................................................. 96
History View ............................................................................................................ 97
Chapter 10. Live Monitoring Mode............................................................................................. 98
10.1. Initiating Monitor Mode ............................................................................................... 98
10.2. Live Monitoring Displays ............................................................................................ 99
Hardware Communications Connections ......................................................... 100
Chapter 11. Sensor Verification ............................................................................................. 102
11.1. Introduction and Overview........................................................................................ 102
Defining Verification Strategy and Criteria........................................................ 103
Selecting the Proper Calibration Bath – Uncertainty (Temperature) ............... 103
11.2. Creating a Verification Setup.................................................................................... 105
Temperature Verification................................................................................... 106
Humidity Verification ......................................................................................... 107
11.3. Loading a Temperature Verification Setup .............................................................. 108
11.4. Loading a Humidity Verification Setup..................................................................... 110
11.5. Selecting Sensors..................................................................................................... 111
11.6. Running a Sensor Verification.................................................................................. 113
11.7. Reasons for Verification Failure ............................................................................... 118
11.8. Verification Report .................................................................................................... 118
Chapter 12. Qualification Reports.......................................................................................... 119
12.1. Reports Overview ..................................................................................................... 119
12.2.Qualification Detailed Report.................................................................................... 121
12.3. Qualification Summary Report ................................................................................. 122
12.4. Graph Reports .......................................................................................................... 123
12.5. Audit Trail Report...................................................................................................... 127
12.6. Spreadsheet Report ................................................................................................. 129
12.7. Pass/Fail Report....................................................................................................... 130

Contents
ValProbe RT User Manual v
12.8. Generating Qualification Reports............................................................................. 138
Selecting a Qualification File............................................................................. 138
Mark Cycles....................................................................................................... 138
Edit Parameters................................................................................................. 141
Report Selection................................................................................................ 144
Appendix A. Specifications ..................................................................................................... 148
A.1 Kaye ValProbe RT System .......................................................................................... 148
A.2 Kaye ValProbe RT Base Station.................................................................................. 149
A.3 Kaye ValProbe RT Logger........................................................................................... 150
Appendix B. Regulatory Compliance and Agency Approvals ............................................ 154
B.1 Electrical Safety Approvals: ......................................................................................... 154
B.2 Radio and EMC Certification Approvals: ..................................................................... 155
B.3 Ingress Protection for Kaye ValProbe RT Logger ....................................................... 157
B.4 United States FDA 21 CFR Part 11 Complaint Software Application......................... 157
B.5 Transportation Regulations.......................................................................................... 158
B.6 FCC Compliance Statement ........................................................................................ 158
B.7 ISED Canada Compliance Statement ......................................................................... 159
B.8 EU Compliance Statement:.......................................................................................... 159
B.9 Product Certification Labels......................................................................................... 160
B.10 China Compliance Statement................................................................................... 161
B.11 Australia Compliance Statement.............................................................................. 162
Appendix C. Environnemental Compliance........................................................................... 163
C.1 Waste Electrical and Electronic Equipment (WEEE) Directive........................................ 163
C.2 Battery Disposal ............................................................................................................... 163
Appendix D. Warranty and Returns:....................................................................................... 165
Appendix E. Service Information ............................................................................................ 166
Appendix F. Warranty and Disclaimer: .................................................................................. 166

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ValProbe RT User Manual 1
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.
The following is a brief description of each Chapter of this User's guide:
•Chapter 1 provides an overview of the ValProbe RT system.
•Chapter 2 explains the ValProbe RT hardware and provides instructions to connect the
system.
•Chapter 3 provides instructions for system connections
•Chapter 4 provides instructions for initial software setup.
•Chapter 5 provides instructions for managing system files.
•Chapter 6provides instructions for entering Kaye equipment into the system.
•Chapter 7 provides instructions for entering assets into the system.
•Chapter 8provides instructions for creating setups.
•Chapter 9 provides instructions for performing a qualification study.
•Chapter 10 provides instructions for displaying live data on the Console.
•Chapter 11 provides instructions on verifying sensors.
•Chapter 12 provides instructions for qualification reports.
*Active Directory™is a registered trademark of the Microsoft Cooperation.

Chapter 1:Kaye ValProbe® RT System
ValProbe RT User Manual 2
Chapter 1. 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 is difficult to access and install. These applications include steam sterilizers, dry heat,
ovens, incubators, stability and temperature chambers, freezers and freeze dryers, and
warehouses.
A complete Kaye ValProbe RT package, includes:
•Base Station
•Kaye Validation Console and installed software
•Docking Station
•Kaye ValProbe RT Loggers
•Wakeup Device
Note: The ValProbe RT product was developed to operate on dedicated networks and should
always be used on networks without Internet access. Furthermore, the ValProbe RT
product does not require an Internet connection to run its functionalities, as it can
function independent of the Internet in either Ethernet or USB mode while in standalone
operation. The product should be connected to non-Internet based LAN networks to
avoid any cyber security issues.

Chapter 1:Kaye ValProbe® RT System
ValProbe RT User Manual 3
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. The communications range between any Logger and the Base Station
is 450 ft. (150 meters). Both the Loggers and Base Station utilize antenna diversity to provide
optimum RF signal strength and reliability.
The Loggers are battery powered using a 3.6V ½ AA Lithium Thionyl Chloride battery. Up to
25 Loggers and 50 sensors can be connected to a Base Station. The Loggers store the data in
their internal memory based on a User defined sampling rate and have a capacity of up to
100,000 samples per sensor. The Loggers also transmit, based on a User defined
transmission rate, the data to the Base Station.
The Loggers have a magnetic-based sensor element in their base, which is activated by using
the Wakeup device or the magnet inside the Base Station display to wake the Logger from
Shelf mode before running a Qualification or Verification.
Figure 3:Handheld Magnet
Figure 4: Magnet Inside Base Station

Chapter 1: Kaye ValProbe® RT System
ValProbe RT User Manual 4
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. As an additional option, connect the Base Station and Console / Docking Station to a
network utilizing dynamic DHCP address, DHCP addresses are software configurable.
The Validation Console is pre-loaded with the ValProbe RT software and is the primary
interface for the operator. The User utilizes the software to configure Setups, Start/ Stop
Qualifications, perform Sensor Verifications, create reports, store Validation studies, and
provide a real-time display. All commands and action generated at the Console are
transmitted to the Base Station and broadcast, via RF, from the Base Station to the Loggers.
1.3. Unpacking
Unpack the Kaye ValProbe RT Loggers, Base Stations, Kaye Validation Console, and
accessories carefully and inspect them for any damage that may have occurred during
shipment. If there is shipping damage, notify the carrier immediately. Verify that the following
are present:
S.No
Base Station Package
Qty
1
ValProbe RT Base Station
1
2
Power adapter for Base Station
1
3
Power cable for adapter
1
4
Kaye #200-166 3.7 V lithium secondary (rechargeable) batteries
2
5
Shielded Ethernet cable 2 meters
1
6
IRTD cable
1
7
Bath cable
1
8
User manual
1
9
Logger opener
1
10
Logger wakeup device
1

Chapter 1:Kaye ValProbe® RT System
ValProbe RT User Manual 5
S.No
Logger Package
Qty
1
ValProbe RT Loggers
As per order
2
Logger batteries
As per order
S.No
Accessories
Qty
1
Kaye Validation Console with docking station and power adapter
(required)
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. Insertion of a non-rechargeable battery may cause
over-heating and explosion.
Utilisez UNIQUEMENT les piles secondaires (rechargeables) au lithium 3,7 V
Kaye #200-166 à l'intérieur de la station de base. L'insertion d'une batterie
non rechargeable peut provoquer une surchauffe et une explosion.
1.4. Safety Information
Use this instrument as specified in this Manual.
•Protection provided by the equipment may be impaired if the equipment is used in a
manner not specified by Kaye.
•Do not use this equipment in environments other than those listed in the Manual.
CAUTION! ONLY Use Kaye #200-166 3.7 V lithium secondary (rechargeable) batteries.
Using any other batteries renders the stated performance void as Kaye
#200-166 3.7V batteries are the only brand tested and accepted.
ATTENTION ! Utilisez cet instrument comme indiqué dans le présent manuel. La
protection fournie par l'équipement peut être compromise si l'équipement
est utilisé d'une manière non spécifiée par Kaye.
Insertion of non-rechargeable battery may cause over-heating and
explosion.
L’insertion d’une batterie non rechargeable peut provoquer un sur-
chauffage et une explosion.

Chapter 2:Kaye ValProbe RT Hardware
ValProbe RT User Manual 6
Chapter 2. Kaye ValProbe RT Hardware
2.1. Kaye ValProbe RT Loggers
The ValProbe RT loggers measure three critical measurands and in eight different hardware
configurations:
•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.
Figure 5: Kaye ValProbe RT Loggers
The Kaye ValProbe RT Loggers are made from pharmaceutical grade polyether ether ketone
(PEEK), 316 stainless steel, and designed for in-situ use. For example, Loggers immersed in
cleaning fluid or detergents, or used in harsh environments. Loggers store study setups and
up to 100,000 pressure samples and 100,000 temperature samples with variable stop / start
conditions in non-volatile memory.
WARNING! Substitution of components may damage the Logger.
Do not heat the Temperature Logger above 140°C.
Do not heat the Pressure/Temperature Logger above 140°C.
Do not submerge the Logger in oil, cleansing liquid or detergents for more
than two hours at temperatures below –20°C. After two hours the O-ring
seal may degrade and should be replaced.
Do not heat the Humidity/Temperature Logger with RH sensor above 70°C.
ATTENTION ! La substitution de composants peut endommager l'enregistreur.
Ne chauffez pas l'enregistreur de température à plus de 140°C.
Ne pas chauffer l'enregistreur de pression/température à plus de 140°C.

Chapter 2:Kaye ValProbe RT Hardware
ValProbe RT User Manual 7
N'immergez pas l'enregistreur dans de l'huile, un liquide de nettoyage ou
des détergents pendant plus de deux heures à des températures
inférieures à -20°C. Après deux heures, le joint torique peut se dégrader
et doit être remplacé.
CAUTION! Any Logger dropped from 3 ft or higher is susceptible to inaccurate temperature
readings; a dropped Logger that inaccurately reads surface temperature is not
considered a manufacturer defect and is not covered under warranty.
ATTENTION ! Tout Logger tombé d'un mètre ou plus est susceptible de donner des
lectures de température inexactes ; un Logger tombé qui donne une
lecture inexacte de la température de surface n'est pas considéré comme
un défaut de fabrication et n'est pas couvert par la garantie.
IMPORTANT: To maintain the seal, the Logger contains a cup O-ring. The cup O-ring should
be replaced whenever the Logger is opened.

Chapter 2:Kaye ValProbe RT Hardware
ValProbe RT User Manual 8
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
±0.1°C
Bendable Loggers Only:
-
85°C to 140°C
140°C to 400°C
±0.1°C
±0.25°C
For Temperature Logger part numbers see below:
S. No
Model name - PMN (Product
Marketing Name)
Model Number
Comments
1
Kaye ValProbe RT Rigid Temperature
Logger
XCVP-L-R-RT
L= Sensor length
in inches, D= dual
sensor
2
Kaye ValProbe RT Single Bendable
Temperature Logger
XCBVP-L-G-RT
3
Kaye ValProbe RT Dual Bendable
Temperature Logger
XCDBVP-La-Lb-G-
RT
4
Kaye ValProbe RT Single Flexible
Temperature Logger
XCFVP-L-RT
5
Kaye ValProbe RT Dual Flexible
Temperature Logger
XCDFVP-L-RT
6
Kaye ValProbe RT Five Channel Flexible
Temperature Logger
XC5FVP-L-RT
7
Kaye ValProbe RT Surface Temperature
Logger
X2534-RT
8
Kaye ValProbe RT Std Rigid Temperature
Logger
XSVP-L-T-RT
L= Sensor length
in inches
T= Tip
configuration
pointed as(P),
round as R & Flat
as (G) D= dual
sensor
9
Kaye ValProbe RT Std Single Bendable
Temperature Logger
XSBVP-L-T-RT
10
Kaye ValProbe RT Std Dual Bendable
Temperature Logger
XSDBVP-La-Lb-T-
RT
11
Kaye ValProbe RT Std Single Flexible
Temperature Logger
XSFVP-C-L-T-RT
C= Sensor length
in inches, L = Tip
length in inches
T= Tip
configuration
pointed as (P) and
round as R
& Flat as (G) D=
dual sensor
12
Kaye ValProbe RT Std Dual Flexible
Temperature Logger
XSDFVP-Ca-La-
Ta-Cb-Lb-Tb-RT
13
Kaye ValProbe RT G Single Bendable
Temperature Logger
XGBVP-L-RT
L= Sensor length
in inches

Chapter 2:Kaye ValProbe RT Hardware
ValProbe RT User Manual 9
14
Kaye ValProbe RT G Dual Bendable
Temperature Logger
XGDBVP-La-Lb-RT
T= Tip
configuration
pointed as (P) and
round as R
& Flat as (G) D=
dual sensor
15
Kaye ValProbe RT CR Rigid Temperature
Logger
X2535-RT
The Temperature Loggers are available in different probe configurations (see Figures below).
Single Type Loggers
Figure 6: Rigid
Figure 7: Flexible
Figure 8:
Bendable
Figure 9: Surface
Multi Type Loggers
Figure 10: Dual Flexible
Figure 11: Dual
Bendable
Figure 12: Five Flexible
The ValProbe RT temperature Loggers provide a single solution for a variety of applications,
such as steam, dry heat, ovens, incubators, stability and temperature chambers, warehouses,
cryogenic chambers, lyophilizes, ultralow freezers, and other ultra-low temperature
applications. Users can perform periodically verifications during the year using the IRTD and
any Kaye calibration bath.

Chapter 2:Kaye ValProbe RT Hardware
ValProbe RT User Manual 10
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 tip length of 1.5”, 3”, 6”, or 9”, and have a diameter of 3mm
/ 0.118”.
Figure 13: Rigid Temperature RT Loggers
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, a range of 360°C is achievable.
Sensor tips are provided in 12”, 18”, 24”, 36” and 48”. Sensor tip diameter is 2.4mm, 0,98”.
To prevent breaking and/or stress on the inner conductors of the bendable Temperature
Logger probe, the following guidelines should be followed:
•Do not bend past the minimum bending radius which is 2x the diameter of the probe.
To ensure that the limit is not exceeded, Kaye recommends bending the probe around
a cylinder with a diameter of the Logger diameter.
•Avoid repeated bending of the probe at the same point.
•The probe should not be bent within one inch of the Logger body or one inch from
where the tip is welded to the probe.
Figure 14: Single Bendable
Figure 15: Dual Bendable