Kaye ValProbe RT User manual

Validation
Kaye ValProbe®RT
User Manual
MXXX-EN Rev. 1.0
May 2020

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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.com

[No content intended for this page]

Contents
Kaye ValProbe RT User Manual i
Kaye ValProbe RT System.........................................................1
1.1. Introduction......................................................................................... 1
1.2. Operational Description...................................................................... 2
1.3. Unpacking........................................................................................... 3
1.4. Safety Information .............................................................................. 4
Kaye ValProbe RT Hardware.....................................................5
2.1. Kaye ValProbe RT Loggers................................................................ 5
2.1.1. Temperature RT Loggers............................................................ 6
2.1.2. Insulating Canister for High Temperatures................................ 12
2.1.3. Inserting a Logger into an Insulating Canister........................... 12
2.1.4. Measurement Range and Accuracy.......................................... 14
2.2. Data Collection................................................................................. 14
2.3. Logger Battery.................................................................................. 15
2.3.1. Battery Replacement................................................................. 16
2.4. Kaye RF ValProbe RT Base Station................................................. 20
2.4.1. Base Station Overview.............................................................. 20
2.4.2. Base Station IRTD / Bath Connections..................................... 21
2.4.3. Base Station Battery Backup..................................................... 21
2.4.4. Base Station LED Indications.................................................... 22
2.4.5. Base Station Wakeup Magnet................................................... 24
2.4.6. Wakeup Device......................................................................... 24
2.4.7. Kayetenna - Extended Antenna Cable...................................... 25
2.5. ValProbe RT Console / Docking Station........................................... 26
ValProbe RT System Connections .........................................28
3.1. Direct Ethernet Connection – Static IP............................................. 28
3.2. Network Ethernet Connection – DHCP ............................................ 31
3.3. Resetting a Base Station.................................................................. 34
3.3.1. Initiating a Factory Reset........................................................... 34

Contents
Kaye ValProbe RT User Manual ii
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. Deleting and Disabling User Accounts...................................... 41
4.4.2. One Time Emergency Access................................................... 42
4.5. Setting Preferences.......................................................................... 43
4.6. Setting Policies................................................................................. 44
4.7. Handling Data Files.......................................................................... 45
4.8. Hardware Maintenance .................................................................... 50
4.9. Online Help....................................................................................... 50
Defining Equipment .................................................................51
5.1. Adding New Equipment.................................................................... 52
5.2. The Equipment Hub.......................................................................... 53
5.3. Checking Details for Existing Equipment.......................................... 54
5.4. Calibration Reminder........................................................................ 55
Defining Assets ........................................................................56
6.1. Asset Details Screen........................................................................ 57
6.2. New Asset Screen............................................................................ 59
Defining Study Setups.............................................................61
7.1. Create a Setup File........................................................................... 62
7.2. Modify an Existing Setup.................................................................. 62
7.3. Define Setup Screen ........................................................................ 63
7.4. Sensors Configuration Screen.......................................................... 64
7.5. Understanding Groups ..................................................................... 65
7.6. Assigning Sensors to Groups........................................................... 66
7.7. Specifying Group Calculations ......................................................... 68

Contents
Kaye ValProbe RT User Manual iii
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. Live Data During Qualification.......................................................... 73
8.4. Live Data During Verification............................................................ 80
8.5. Check CommunicationsConnections............................................... 82
8.6. Select a TemperatureStandard ........................................................ 83
8.7. Access Study Files........................................................................... 83
Qualification Study...................................................................84
9.1. Introduction....................................................................................... 84
9.2. Load a Setup .................................................................................... 85
9.2.1. Select a Setup File .................................................................... 85
9.3. Viewing the Active QualificationStudy.............................................. 86
9.4. Graph Real-Time Sensor Readings and Calculations....................... 87
Sensor Verification...................................................................88
10.1. Introduction and Overview ............................................................ 88
10.1.1. Defining Verification Strategy and Criteria............................. 89
10.1.2. Selecting the Proper Calibration Bath - Uncertainty .............. 89
10.2. Creating a Verification Setup........................................................ 91
10.3. Loading a Verification Setup......................................................... 93
10.4. Selecting Sensors......................................................................... 94
10.5. Running a Sensor Verification.............................................................. 95
10.6. Reasons for Verification Failure .................................................... 99
10.7. Verification Report......................................................................... 99
QualificationReports..............................................................100
11.1. Reports Overview........................................................................ 100

Contents
Kaye ValProbe RT User Manual iv
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
11.7. Pass/Fail Report ......................................................................... 111
11.8. Generating Qualification Reports................................................ 120
11.8.1. Selecting a Qualification File ............................................... 120
11.8.2. Mark Cycles......................................................................... 120
11.8.3. Edit Parameters................................................................... 123
11.8.4. Report Selection.................................................................. 126
11.9. Edit Parameters Screen.............................................................. 129
11.10. Report Selection ......................................................................... 130
11.11. Grouping Sensors....................................................................... 131
Appendix A. Specifications.........................................................................135
A.1 Kaye ValProbe RT System............................................................. 135
A.1.1List of Certified Countries........................................................ 135
A.1.2 Regulatory Compliance........................................................... 135
A.1.3 RF System Operating Frequency and Modulation .................. 135
A.1.4 RF Channels ........................................................................... 135
A.1.5 RF Network Topology and PAN ID (Network ID)..................... 135
A.1.6 Antenna Diversity.................................................................... 135
A.1.7 Data Rate and Data Encryption............................................... 135
A.1.8 RF Range (Line of Sight and Outdoor).................................... 135
A.1.9 Number of Loggers and Sensors Supported........................... 135
A.1.10 Sensor Sampling Rate ............................................................ 135
A.1.11 Data Transmission Rate.......................................................... 135
A.1.12 Sensor Samples Data Storage Capacity................................. 135

Contents
Kaye ValProbe RT User Manual v
A.1.13 Optional Extendable Base Station Antenna............................ 135
A.2 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................................................ 136
A.2.5 Front Panel LED Indications and Buzzer ................................ 136
A.2.6 Bath and IRTD Interface Ports................................................ 136
A.2.7 USB Port ................................................................................. 136
A.2.8 Ethernet Communication Port................................................. 136
A.2.9 Reset Switch to Reload Default Factory Settings.................... 136
A.2.10 Wakeup Magnet...................................................................... 136
A.2.11 Batteries.................................................................................. 136
A.2.12 Unit Dimensions...................................................................... 136
A.2.13 Enclosure Material................................................................... 137
A.2.14 Environmental Ratings............................................................ 137
A.3 Kaye ValProbe RT Logger.............................................................. 137
A.3.1 Installation Category................................................................ 137
A.3.2 Overvoltage Category and Electrical Safety Protection Class 137
A.3.3 Magnetic Switch...................................................................... 137
A.3.4 LED Indications....................................................................... 137
A.3.5 Calibration............................................................................... 137
A.3.6 Real Time Clock Accuracy...................................................... 137
A.3.7 Sensing Elements ................................................................... 137
A.3.8 Housing Material ..................................................................... 138
A.3.9 Logger Base Dimensions........................................................ 138
A.3.10 Ingress Protection ................................................................... 138
A.3.11 Insulating Canister X2545....................................................... 138

Contents
Kaye ValProbe RT User Manual vi
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:.................................................. 138
A.4.3 Number of Input Channels ...................................................... 138
A.4.4 Sensor Types and Measurement Range................................. 138
A.4.5 Sensor Lengths....................................................................... 139
A.5.1 Measurement Accuracy........................................................... 139
A.5.2 Body Environmental ratings: ................................................... 139
A.5.3 Number of Input Channels ...................................................... 139
A.5.4 Sensor Types and Measurement Range................................. 139
A.5.5 Sensor Lengths....................................................................... 139
A.6.1 Measurement Accuracy........................................................... 139
Appendix B. Regulatory Compliance and Agency Approvals.................140
B.1 Electrical Safety Approvals:............................................................ 140
B.1.1 European Safety Certification.................................................. 140
B.1.2 UL USA Safety Certification.................................................... 140
B.1.3 Canada Safety Certification..................................................... 140
B.1.4 IEC and CB Scheme Certification........................................... 141
B.2 Radio and EMC Certification Approvals:........................................ 141
B.2.1 USA FCC and Canada ISED................................................... 141
B.2.2 European Radio and EMC Certification Approvals:................. 142
B.3 Ingress Protection for Kaye ValProbe RT Logger .......................... 142
B.4 United States FDA 21 CFR Part 11 Complaint Software Application
142
B.5 Transportation Regulations ............................................................ 143
B.6 FCC Compliance Statement........................................................... 143
B.7 ISED Canada Compliance Statement............................................ 143

Contents
Kaye ValProbe RT User Manual vii
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. Environnemental Compliance ..............................................146
C.1 Waste Electrical and Electronic Equipment (WEEE) Directive........... 146
C.2 Battery Disposal.................................................................................. 146
C.2.1 What do the Markings Mean?...................................................... 147
C.2.2 The Risks and Your Role in Reducing Them............................... 147
Appendix D. Warranty and Returns: ..........................................................148
Appendix E. Service Information................................................................149

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 creating user accounts.
•Chapter 4 provides instructions for entering Kaye equipment into the system.
•Chapter 5 provides instructions for entering assets into the system.
•Chapter 6 provides instructions for creating setups.
•Chapter 7 provides instructions for performing calibration or verification.
•Chapter 8 provides instructions for displaying live data on the Console.
•Chapter 9 provides instructions for performing a qualification study.
•Chapter 10 provides instructions for creating reports.

Chapter 1:Kaye ValProbe RT System
Kaye ValProbe RT User Manual 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 can be difficult to
access and install. These applications include steam, dry heat, ovens,
incubators, stability and temperature chambers, freezers and freeze dryers,
and warehouses. A complete Kaye ValProbe package, includes:
•Base Station
•Kaye Validation Console and installed software
•Docking Station
•Kaye ValProbe RT Loggers
•Wakeup Device

Chapter 1:Kaye ValProbe RT System
Kaye ValProbe RT User Manual 2
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. Dependent on model type the loggers can collect
temperature and pressure data from (-85C to 140 C). 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 the logger which
gets activated by using the Wake- up Tool or the magnet inside the Base
Station display to Wake up the logger from Shelf mode prior to running a
Qualification or Verification.
Figure 3:Handheld Magnet
Figure 4: Magnet Inside Base
Station

Chapter 1:Kaye ValProbe RT System
Kaye ValProbe RT User Manual 3
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.
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 real-time display. All
commands and action generated at the Console are transmitted to the Base
Station and then 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
S.No
Logger Package
Qty
1
ValProbe RT Loggers
As per order
2
Logger batteries
As per order

Chapter 1:Kaye ValProbe RT System
Kaye ValProbe RT User Manual 4
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. Insertion of
a non-rechargeable battery may cause over-heating and
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! Use ONLY 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.
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.

Chapter 2:Kaye ValProbe RT Hardware
Kaye ValProbe RT User Manual 5
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.
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, they can be immersed in cleaning fluid or detergents, or
used in harsh environments. They can store the study setup 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.
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.

Chapter 2:Kaye ValProbe RT Hardware
Kaye ValProbe RT User Manual 6
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
±0.1°C
Bendable Loggers Only:
-
85°C to 140°C
140°C to 400°C
±0.1°C
±0.25°C
For 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

Chapter 2:Kaye ValProbe RT Hardware
Kaye ValProbe RT User Manual 7
13
Kaye ValProbe RT G Single Bendable
Temperature Logger
XGBVP-L-RT
L= Sensor length
in inches
T= Tip
configuration
pointed as (P) and
round as R
& Flat as (G) D=
dual sensor
14
Kaye ValProbe RT G Dual Bendable
Temperature Logger
XGDBVP-La-Lb-RT
15
Kaye ValProbe RT CR Rigid Temperature
Logger
X2535-RT
16
Kaye ValProbe RT Pressure Temperature
Logger
X2532-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
Two and Multiples Type Loggers
Figure 10: Dual
Flexible
Figure 11: Dual
Bendable
Figure 12: Five
Flexible
The ValProbe RT Logger is a temperature logger that provides 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.