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Validation
Kaye ValProbe® RT
User Manual
M5630-EN Rev. D
October 2022
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®
Kaye ValProbe
Process Monitoring and Validation System
User Manual
M5630-EN Rev. D
RT
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
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
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Contents
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
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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
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Contents
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
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Generating Qualification Reports ............................................................................. 138
12.8.
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
ValProbe RT User Manual v
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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 6 provides instructions for entering Kaye equipment into the system.
• Chapter 7 provides instructions for entering assets into the system.
• Chapter 8 provides 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.
ValProbe RT User Manual 1
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Chapter 1. Kaye ValProbe® RT System
1.1. Introduction
Figure 1: The Kaye ValProbe RT
Chapter 1: Kaye ValProbe® RT System
®
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.
ValProbe RT User Manual 2
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Chapter 1: Kaye ValProbe® RT System
Figure 3:Handheld Magnet
Figure 4: Magnet Inside Base Station
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.
ValProbe RT User Manual 3
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Chapter 1: Kaye ValProbe® RT System
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
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:
ValProbe RT User Manual 4
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Chapter 1: Kaye ValProbe® RT System
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
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
(required)
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 surchauffage et une explosion.
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Chapter 2: Kaye ValProbe RT Hardware
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.
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Chapter 2: Kaye ValProbe RT Hardware
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.
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Chapter 2: Kaye ValProbe RT Hardware
Temperature
Accuracy
-85°C to 140°C
±0.1°C
Bendable Loggers Only:
140°C to 400°C
S. No
Model name - PMN (Product
Marketing Name)
Model Number
Comments
1
Kaye ValProbe RT Rigid Temperature
Logger
XCVP-L-R-RT
2
Kaye ValProbe RT Single Bendable
Temperature Logger
XCBVP-L-G-RT
3
Kaye ValProbe RT Dual Bendable
Temperature Logger
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
8
Kaye ValProbe RT Std Rigid Temperature
Logger
L= Sensor length
sensor
9
Kaye ValProbe RT Std Single Bendable
Temperature Logger
10
Temperature Logger
RT
11
Kaye ValProbe RT Std Single Flexible
Temperature Logger
C= Sensor length
dual sensor
12
13
Kaye ValProbe RT G Single Bendable
Temperature Logger
XGBVP-L-RT
L= Sensor length
in inches
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
85°C to 140°C
±0.1°C
±0.25°C
For Temperature Logger part numbers see below:
Kaye ValProbe RT Std Dual Bendable
XCDBVP-La-Lb-G-
L= Sensor length
in inches, D= dual
sensor
X2534-RT
XSVP-L-T-RT
XSBVP-L-T-RT
XSDBVP-La-Lb-T-
in inches
T= Tip
configuration
pointed as(P),
round as R & Flat
as (G) D= dual
Kaye ValProbe RT Std Dual Flexible
Temperature Logger
ValProbe RT User Manual 8
XSFVP-C-L-T-RT
XSDFVP-Ca-LaTa-Cb-Lb-Tb-RT
in inches, L = Tip
length in inches
T= Tip
configuration
pointed as (P) and
round as R
& Flat as (G) D=
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Chapter 2: Kaye ValProbe RT Hardware
14
Temperature Logger
T= Tip
dual sensor
15
Kaye ValProbe RT CR Rigid Temperature
Logger
Single Type Loggers
Bendable
Multi Type Loggers
Bendable
configuration
XGDBVP-La-Lb-RT
Kaye ValProbe RT G Dual Bendable
X2535-RT
pointed as (P) and
round as R
& Flat as (G) D=
The Temperature Loggers are available in different probe configurations (see Figures below).
Figure 6: Rigid
Figure 7: Flexible
Figure 8:
Figure 9: Surface
Figure 10: Dual Flexible
Figure 11: Dual
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.
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Chapter 2: Kaye ValProbe RT Hardware
Figure 14: Single Bendable
Figure 15: Dual Bendable
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.
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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 tip 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. These sensors are optimized to be used for Shelf mapping for Freeze Dryers.
The flat surface diameter of the sensor is 32mm.
Figure 17: Surface Temperature RT Logger
ValProbe RT User Manual 11
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Chapter 2: Kaye ValProbe RT Hardware
Pressure/Temperature Loggers
The ValProbe RT Pressure/Temperature Logger (X2532-RT) 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.
ATTENTION! N'insérez pas d'objets dans le haut de l'enregistreur de pression. Cela
pourrait endommager le diaphragme de l'enregistreur et invalider les
relevés de pression.
Note: Clean the Pressure Logger with an alcohol rinse and then airdry.
ValProbe RT User Manual 12
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Chapter 2: Kaye ValProbe RT Hardware
Humidity Loggers
The Kaye ValProbe T/H Logger (model X2520) utilizes a field replaceable digital sensor to
accurately measure Temperature and Humidity from 0C° to 70C° and 15% to 95% relative
humidity. The accuracy is ±0.15C° for temperature and up to ±2% accuracy. The Humidity
logger includes a removable filter cap and a one-meter extension cable for verifying the
temperature sensor inside a dry block.
Note: When performing user verification, first complete the temperature
calibration/verification and then the humidity verification. Ensure the Logger is allowed
time to dry following the temperature verification. The verification procedures are
described in the online help included with the Kaye ValProbe software.
Figure 19: Humidity Loggers
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Chapter 2: Kaye ValProbe RT Hardware
Insulating Canister for High Temperatures
The Kaye ValProbe RT Insulating Canister (Part Number X2545) enables operation of
bendable Temperature Loggers from up to 400°C, by ensuring that the Logger base does not
exceed 140°C.
Figure 20: 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.
ATTENTION ! N'utilisez le boîtier isolant que dans des endroits non dangereux.
Inserting a Logger into an Insulating Canister
For dual and single bendable Loggers only, unscrew the protective housing cap from the
Logger.
Remove the cap by pressing down on the cap and turning it counterclockwise until the clips are
free from the tabs.
Place the PEEK cylinder over the bendable Temperature Logger probe and slide it to the
base of the Logger.
Place the Logger and PEEK cylinder into the canister.
Insert the probe through the Insulating Canister cap center hole and slide the cap to the
cylinder base. Line up the clips with the tabs on the cylinder base. Press down on the cap
and turn clockwise so that the clips are secured onto the tabs.
Figure 21: Inserting a Logger into an Insulating Canister
ValProbe RT User Manual 14
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Chapter 2: Kaye ValProbe RT Hardware
Temperature
Maximum Time
360°C
40 minutes
300°C
60 minutes
250°C
90 minutes
200°C
120 minutes
175°C
180 minutes
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.
CAUTION! If the Logger and Insulating Canister remain at a high temperature longer
than the maximum time indicated in the table, the Logger base may be
subjected to temperatures greater than 140°C, which can damage the
Lithium Thionyl Chloride battery. This may result in a leakage of electrolyte.
Si la Logger et la boîte isolante restent à une température élevée plus
longtemps que le temps maximal indiqué dans la table, la base de Logger
peut être soumise à des températures supérieures à 140°C, ce qui peut
endommager la batterie de chlorure de thionyl au lithium. Cela peut
entraîner une fuite d’électrolyte.
WARNING! In the event the Logger base has been subjected to temperatures above
140°C, safety glasses and protective gloves should be worn before
attempting to service the Logger to avoid electrolyte contact with eyes and
skin.
If skin contact occurs, flush with cold water for at least 15 minutes. If
symptoms persist, seek medical attention.
If eye contact occurs, flush with cold water for at least 15 minutes and seek
medical attention.
Dans le cas où la base Logger a été soumise à des températures supérieures
à 140 oC, des lunettes de sécurité et des gants de protection doivent être
portés avant de tenter de servir le Logger pour éviter tout contact électrolyse
avec les yeux et la peau.
Si un contact cutané se produit, rincer à l’eau froide pendant au moins 15
minutes. Si les symptômes persistent, consultez un médecin.
Si un contact visuel se produit, rincer à l’eau froide pendant au moins 15
minutes et consulter un médecin.
After a high-temperature study is complete, allow the canister to cool to room temperature.
Remove the cap and the PEEK cylinder and if required, wakeup the Logger with a magnet to
establish communication between the Logger and Base Station.
ValProbe RT User Manual 15
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Chapter 2: Kaye ValProbe RT Hardware
Measurement Range
Accuracy
Temperature Loggers
-85°C to 140°C
±0.10°C
Bendable Temperature Loggers with Insulating Canister
140°C to 400°C
±0.25°C
Pressure Loggers
0°C to 120°C
±25 mb
Humidity Logger
15% to 95% RH (non-condensing)
Options
Qual Start
Qual Stop
2
Manual
Cycle Time
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
120°C to 135°C
135°C to 140°C
0°C to 70°C
±10 mb
±25 mb
±
2% RH at 25°C to 40°C
±
0.15°C
2.2. Data Collection
Each Kaye ValProbe RT Logger collects and stores up to 100,000 data samples per sensor in
onboard Logger memory at a User-specified sample rate. If the Loggers reaches 100,000
samples, then the Logger stops collecting any further data. Data stored in the Logger is stored
in non–volatile memory and is retained until a new Qualification or Verification is loaded.
Loggers may be programmed to start data collection manually when the Qualification is
started and programmed to stop collection manually or based on cycle time.
Table 4: Qualification Start / Stop Conditions and Related Delays:
1 Manual Manual
3 Time of Day Manual
4 Time of Day Cycle Time
• Time of Day cannot be programmed for more than 72 hours after the Loggers are
programmed. After 72 hours, if a study is not started, Loggers are returned to sleep /
shelf mode.
• Cycle Time does not have a duration limit, cycle time duration depends on the sampling
rate and number of samples. The maximum number of samples collected are 100,000
per sensor.
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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 non-hazardous.
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 (See
Section 2.1.4).
Use only the factory-specified battery (part number M3205) in the Kaye
ValProbe RT Logger. The use of non-specified batteries will void the
warranty and may damage the Logger and/or cause burns to the operator.
Replacement battery kits are available from Kaye.
Batteries must be disposed of in accordance with local, state, and federal
regulations.
ATTENTION ! Pour éviter tout allumage dans une atmosphère dangereuse, la batterie
doit être changée uniquement dans une zone connue pour être non
dangereuse.
Ne pas chauffer la pile à plus de 140ºC. Pour mesurer des températures
supérieures à 140ºC, une sonde spéciale et un conteneur isolant sont
nécessaires pour maintenir la température du Logger en dessous de
140ºC pendant toute la durée de l'étude. (Voir Section 2.1.4).
Utilisez uniquement la batterie spécifiée en usine (référence M3205)
dans l'enregistreur Kaye ValProbe RT. L'utilisation de batteries non
spécifiées annulera la garantie et peut endommager le Logger et/ou
caUser des brûlures à l'opérateur. Des kits de batteries de
remplacement sont disponibles auprès de Kaye.
Les batteries doivent être mises au rebut conformément aux
réglementations locales, nationales et fédérales.
Before starting a Qualification in the Select Logger screen, a Battery Estimate button displays,
that if selected, navigates to a screen to enter the min and max temperature of the process
and the duration of time. Once entered the estimator displays the battery life remaining as well
as the estimated usage during the Qualification. This provides assurances that you have
ample battery life remaining for the study.
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Battery Estimator
Figure 22: Battery Estimation Screen
The Kaye ValProbe RT software tracks each Logger's battery life to within 10% of a potential
low-voltage occurrence to help prevent interrupted or incomplete studies. When determining
the battery life remaining, the software bases its calculations on the assumption that the
battery can supply a predictable amount of energy (mAh) over the temperature range.
When the batteries are used in environments at room temperature or above, and the battery
life runs down to a fixed percentage, that remaining percentage is generally not available in
environments below room temperature due to battery chemistry. The battery life calculation is
accurate when a Logger is used exclusively for studies at or above room temperature, or
exclusively for studies below room temperature.
Kaye recommends replacing the battery when there is 10% battery life remaining. If the
battery life falls below 10%, the study may stop early.
• If the battery is fully drained or is removed, the study setup and data, as well as the
calibration information, are maintained in non-volatile memory inside the Logger.
• 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 read
once a new battery is installed.
• If a battery is fully drained after a study is complete, all study data is readable once a
new battery is installed.
• If changing the battery before a study is started, re-program the Logger. Although the
setup is maintained in non-volatile memory, the Logger needs to be programmed in
order to reset its clock.
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Battery Replacement
Kaye recommends replacing the battery when there is 10% battery life remaining. The battery
percentage indicator (text color) is based on the battery percentage value, between
0%-19% in Red, 20% to 49% in Orange, and 50% to 100% in Green.
Battery replacement is a three-step process involving:
• Removing the Existing O-ring and Battery
• Installing the Replacement O-ring and Battery
• Resetting the Battery Odometer
Open the Logger and Remove the Existing O-ring and Battery
WARNING! To ensure that the Logger maintains its waterproof and pressure-tight seal,
a thin coat of grease was applied to the O-ring. The grease material is
KRYTOX GL-203, and safe handling and storage practices should be
followed. KRYTOX is a registered trademark of DuPont Chemicals. Material
Safety Data information is available from DuPont Chemicals.
ATTENTION ! Pour garantir que le Logger conserve son étanchéité à l'eau et à la
pression, une fine couche de graisse a été appliquée sur le joint torique.
La graisse est du KRYTOX GL-203, et des pratiques de manipulation et de
stockage sûres doivent être suivies. KRYTOX est une marque déposée de
DuPont Chemicals. Les informations sur les données de sécurité sont
disponibles auprès de DuPont Chemicals.
• Slide the Logger opener over the probe tip and onto the top of the Logger. Unscrew the
bottom cup while holding the opener firmly against the probe base.
Figure 23: Open Logger
• Remove the battery cap by pressing down on it and turning counterclockwise.
• With the cap removed, pull the battery out of the enclosure.
• To remove the O-ring, lift it from the groove and slide off in the direction of the probe
tip.
Figure 24: Remove the Old Battery and O-ring
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Install the Replacement O-ring and Battery:
Whenever opening a Logger, 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.
• Before installing a new O-ring, apply a thin coat of grease to the O-ring (see warning
above regarding KRYTOX grease). Carefully apply the grease to all surfaces of the Oring, ensuring not to cut or scratch the O-ring.
Figure 25: Apply Grease and Replace O-ring
• Slide the O-ring over the tip end of the probe and into the O-ring groove. Do not stretch
or deform the O-ring and avoid contact with the threads to prevent nicking and/or
cutting the O-ring.
• With the new O-ring in place, insert the pre-conditioned battery into the battery holder
and place the battery cap on top and turn the cap down and clockwise to lock it into
place.
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• Once the battery is installed, a small red LED on the top edge of the board blinks three
times to confirm that the Logger is powered on. If the LED light does not blink, follow
the important note below to troubleshoot.
Figure 26: Insert New Battery / Verify LED
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.
• Reinsert the Logger cover and hand tighten until the cup O-ring is no longer visible.
Clean the exterior of the Logger with a soft cloth to remove any excess lubricant.
Reset the Battery Odometer
When changing the battery in a Logger, also reset the battery odometer to 100% for the
program to calculate the life of the new battery.
Reset Battery Life:
• Start the ValProbe RT software.
• Navigate to the Hardware Discover tile, select a Base Station and then select the
Connect button.
Figure 27: Connect Button
• Wake up all Loggers that have had battery replacements using the Wakeup device or
the Base Station magnet.
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• From the Logger Configuration screen, select the Loggers and then Battery Reset.
Figure 28: Select Loggers
• Once the Loggers Status window displays, select the Loggers to reset from the lower
left dropdown in the Logger Reset screen, and select Battery Reset.
• Select OK when prompted to continue the battery reset and then enter User
credentials.
Figure 30: Logger Battery Reset Prompt
• When all Logger battery resets are complete, ensure that their status displays Success
in the Status column.
Figure 29: Logger Battery Reset
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2.4. Kaye 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. The wireless range from the Base Station to any Logger is 450 ft. (~150 meters).
Figure 31: ValProbe RT Base Station
CAUTION! Use only the Kaye power supply (Kaye #201-3006) provided with your
ValProbe RT. The use of non-factory power supplies may damage the
equipment and will void your warranty.
ATTENTION !Utilisez uniquement l’alimentation Kaye (Kaye #201-3006) fournie avec
votre ValProbe RT. L’utilisation d’alimentation non-usine peut
endommager l’équipement et annuler votre garantie.
Base Station Power / Communications Connection
The Base Station also provides an Ethernet connection at the base of the unit for
communications from the Base Station directly to the Console / Docking Station (Static IP) or
by using an ethernet network connection via DHCP. (See Chapter 3 for details on connection
options and configuration.)
The base of the unit also includes the connection for the supplied Power Supply as well as a
Reset button for service emergencies (See Chapter 3).
Figure 32: Base Station Connections
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Base Station IRTD / Bath Connections
Located at the rear of the Base Station, IRTD and Kaye References connections are used for
Sensor Verification. Using the supplied cables, connect the IRTD and bath to the appropriately
marked connectors. Cables and connections are backward compatible to all Kaye baths, dry
blocks, and IRTDs. The ValProbe RT software provides fully automated sensor verification of
ValProbe RT Loggers (See Chapter 11 for details on Sensor Verification).
Figure 33: IRTD / Kaye Bath Connections
Base Station Battery Backup
Kaye ValProbe RT Base Station has battery backup for up to 60 minutes. The Base Station is
powered by two 3.7V AA size rechargeable Lithium batteries. The Base Station has a built-in
charger, so batteries are charged automatically when there is a main supply available to the
Base Station. To replace batteries, first shut off the Base Station using ON-OFF switch. Then,
open the sliding panel on the back of the Base Station and replace the batteries in the
compartment displayed in the figure below. Do not power on the Base Station until the
compartment cover is properly secured.
Figure 34: ValProbe RT Base Station Battery Compartment
CAUTION! ONLY Use Kaye #200-166 3.7 V lithium secondary (rechargeable) batteries.
Using any other batteries renders the stated performance void as Kaye #200166 3.7V batteries are the only brand tested and accepted.
ATTENTION ! Utilisez UNIQUEMENT les piles secondaires (rechargeables) au lithium
3,7 V de Kaye #200-166. L'utilisation de toute autre pile annule les
performances indiquées, car les piles Kaye #200-166 3,7 V sont les seules
à avoir été testées et acceptées.
Insertion of a non-rechargeable battery may cause over-heating and
explosion.
L'insertion d'une batterie non rechargeable peut provoquer une surchauffe et une
explosion.
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Base Station LED Indications
The Base Station LED panel provides multi-colored status indications of items such as:
Figure 35: Base Station Status Panel
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Figure 36: Base Station LED Indication Chart
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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.
• GREEN blinking indicates that a data transfer is in progress to USB storage.
• RED blinking indicates a data transfer error to the USB storage.
• BLUE indicates that a firmware upgrade is in progress or the study stopped.
• BLUE blinking indicates that RF data retrieval is in progress.
COMMUNICATION LED:
• GREEN indicates that the console is connected with the Base Station.
Other Scenarios:
• All colors (RED, GREEN, and BLUE) blink once after power on,
• All four lights blink RED, indicates that a Logger joined with the Base Station.
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Base Station Wakeup Magnet
A powerful neodymium magnet is located behind the LED panel to the Kaye logo. The magnet
is used to wake up Loggers from sleep mode prior to connection and execution of a
Qualification or Verification. 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. Stopping a Logger during
Qualification or Verification is controlled by the completion or cancellation of a study by a User.
Loggers return to a sleep mode if during Idle mode, there is inactivation of communication for
15 min. Keep any magnetic sensitive devices away from the Base Station. In addition to the
Wakeup device the Base Station can also be used to wake up loggers.
Figure 37: Wakeup Magnet
Wakeup Device
Figure 38: Wakeup Device for Logger
The Wakeup device is a plastic enclosure with a permanent magnet inside. It helps to wake
Loggers from Sleep mode. The powerful neodymium magnet is located behind the Kaye logo.
Keep the Wakeup device away from magnetic sensitive parts. To wake a Logger from sleep
mode swipe near the Kaye logo on the Wakeup Device.
CAUTION! The Base Station and Wakeup device contain magnets and may affect
devices.
Attention ! La station de base et le dispositif de réveil contiennent des aimants et
peuvent affecter les appareils.
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Magnet warning: Avoid placing any media that contains magnets or is sensitive to
magnetism near this product. Magnet sensitive devices such as laptops, credit cards,
or magnetic memory devices can be damaged if they are placed close to this product,
so take extra care to prevent loss.
Avertissement concernant les stimulateurs cardiaques : Les aimants à
l'intérieur de la station de base et de l'appareil de réveil peuvent caUser des
interférences avec les appareils médicaux situés à proximité, tels que les
stimulateurs cardiaques, les défibrillateurs cardiaques implantés, etc. Ne
transportez pas et n'utilisez pas la station de base ou l'appareil de réveil à
proximité d'appareils médicaux et avertissez les autres personnes qui
portent des appareils médicaux de ne pas s'approcher des aimants.
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.
Avertissement concernant les aimants : Évitez de placer tout
support contenant des aimants ou sensible au magnétisme à
proximité de ce produit. Les appareils sensibles aux aimants,
tels que les ordinateurs portables, les cartes de crédit ou les
dispositifs de mémoire magnétique, peuvent être
endommagés s'ils sont placés à proximité de ce produit, alors
prenez des précautions supplémentaires pour éviter toute
perte.
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Figure 39: Kayetenna
Figure 40: Base Station with Kayetenna
Kayetenna - Extended Antenna Cable
The Base Station and Loggers are designed with a feature called Antenna diversity. Antenna
diversity utilizes two separate antennas that look for the best signal strength across two planes
to maximize distance, signal strength, and reliability. For some extremely difficult applications
such as large autoclaves, with thick walls where communications could be difficult, Kaye offers
an optional two-meter antenna cable (Kayetenna) to fed into the chamber via a feedthrough to
improve communications reliability. To install the Kayetenna to the Base Station, replace the
diversity antenna on the Base Station.
2.5. ValProbe RT Console / Docking Station
z
Figure 41: 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. The Console also includes all
related ValProbe RT software and documents such as the User Manual and SOP. Additional
features include:
• IP54 rated (water, dust, and splash resistant)
• Durable Gorilla Glass
• Rubberized for shock dampening
• Hot swappable battery (six hours)
• On-board camera for generation of sensor layout pictures
The ValProbe RT System also includes a portable docking station for easy access and
viewing. The docking mechanism is adjustable for optimum viewing and includes additional
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USB and Ethernet ports for connection to the Base Station or network and optional equipment
such as a wireless keyboard / mouse etc. The Docking Station includes a power supply (100 –
240 VAC) for charging the Console during use.
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.
The ValProbe RT software contains features to perform the following validation tasks:
• Create Assets
• Create Setups
• Run Qualification Studies
• Perform Sensor Verification
• Create Qualification Reports and Graphs
• Storage of Validation files
• Sync In, Sync Out and Archive of Data
• User Permission management
• Audit Trail review and analysis
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Chapter 3. 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 42: 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. The
Console Ethernet adapter setting is set for a Static IP address of 192.168.99.55.
To connect via direct connection and verify system connectivity do the following:
Attach the supplied cross-linked Ethernet cable to the Ethernet connector located at the
base of the Base Station to the Ethernet connector located on the Docking Station.
Figure 43: Base Station Connection
Plug in the Docking Station to a power source.
Ensure the Console is in the Docking Station and press the Power button on the Console.
Power the Base Station and wait until the Power Led is solid green.
Log in and proceed to ValProbe RT software.
From the Main Menu of the ValProbe RT software select the Discover tile.
(If the Base Station is properly connected the Base Station blue tile appears and the Ethernet
IP address of 192.168.99.50).
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Select the Base Station and then Connect. The Base Station should connect and move to
the Select Loggers screen.
Figure 44: Select Base Station Screen
If the Base Station was found and communication have been established, a blue tile
signifying the Base Station appears with an IP Address 192.168.99.50.
Select the Base Station tile and then select Setup BS connection to open the Base
station Setup screen.
Figure 45: Select Base Station Screen
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Figure 46: Setup Base Station Connection
Note: If the problem persists, contact technical support.
Once the Base Station is discovered and selected the BS Settings offers additional
customization of your Base Station. 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.
Figure 47: Setup BS Connection
Note: To ensure changes are implemented, select Apply Changes to save any
changes.
When completed, select the X to return to the Select Base Station screen.
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3.2. Network Ethernet Connection – DHCP
Figure 48: Network Connection
The ValProbe RT can also be configured to communicate using a company or private network
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. To
change this for Network connection using DHCP the system must be first connected via Direct
Connection to communicate the changes to the Base Station.
To convert the system from Direct Ethernet connection via Static IP to a network connection
via DHCP, perform the following steps:
Connect the system via Direct Connection following Steps1-9 in Section 3.1.
From the Main Menu select Discover to go to the Select Base Station Screen. Select the
Base Station connected via direct connect with an IP address of 192.168.99.50 then press
Setup BS Connection.
Select Set Base Station IP.
Figure 49: Set Base Station IP
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From the Setting Base Station Connection window change the Type of IP Address from
Static to DHCP. Connect the supplied Ethernet cable from the Base Station to the network
ethernet port and define network IP Address, Subnet Mask, and Default Gateway and then
select Apply Changes.
Figure 50: Change to DHCP
The changes are stored in the Base Station and the software attempts to communicate
with the Base Station. Follow the prompts until Base Station connection is found.
Note: If you ever want to return to Direct / Static IP connection simply select Static and select
Default IP.
• Return to the ValProbe RT software’s Select Base Station screen.
Figure 51: 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.
Note: The discovery function can only detect Base Stations in the same IP segment and
the same subnet as the computer. If the Base Station is not in the same sub
segment or configured to another subnet mask, manually add the IP using the Add
button. If Base Station discovery was unsuccessful, contact Kaye support or your
company IT department.
WARNING! If a Base Station is configured to a static IP address, it is the only way to
communicate with it. If the IP is changed and the “Apply” command is sent,
the previous setup is not active for any further connection. If the IP address
is not reachable or forgotten, the Base Station may need to be reset.
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DEFAULT FACTORY SETTINGS
Base Station
Mode
IDLE
Ethernet
Mode
STATIC
IP ADDRESS
192.168.99.50
PANID
3072
RF CHANNEL
23
REGION
US
System Name
VPRT Base Station
Location
Anywhere
ATTENTION ! Si une station de base est configurée avec une adresse IP statique, c'est
le seul moyen de communiquer avec elle. Si l'adresse IP est modifiée et
que la commande "Appliquer" est envoyée, la configuration précédente
n'est pas active pour toute autre connexion. Si l'adresse IP n'est pas
joignable ou si elle est oubliée, la station de base peut avoir besoin d'être
réinitialisée.
3.3. Resetting a Base Station
Initiating a Factory Reset
Press the Reset button 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.
Note: During Factory reset, the Base Station restarts after a few seconds (10 seconds max),
throughout this time the LED sequence is the same as initial power ON (all LED RED,
GREEN, BLUE) and the Power LED blinks.
When the Power LED is no longer blinking, but consistently lit, reconnect to the Base
Station using the software.
At the completion of the Base Station reset, the following settings below are set, and any
connected Loggers are set to idle.
CAUTION! Pressing RESET restores the Base Station to factory settings. The Base
Station mode changes to IDLE, the IP address changes to the STATIC default
of 192.168.99.50, the name and location are reverted to defaults, and all
Loggers are forgotten.
ATTENTION ! En appuyant sur RESET, la station de base revient aux réglages
d'usine. Le mode de la station de base passe à IDLE, l'adresse IP
passe à la valeur par défaut STATIC de 192.168.99.50, le nom et
l'emplacement sont rétablis aux valeurs par défaut et tous les
enregistreurs sont oubliés.
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Chapter 4: Initial ValProbe RT Software Setup
Chapter 4. Initial ValProbe RT Software Setup
4.1. Introduction
Before utilizing the ValProbe RT software to run Qualification studies, it is necessary to initially
sign in using the Default Kaye ValProbe RT account and then create a System Administrator
account. The Kaye Default System Administrator account is automatically deleted when the
Password Maintenance utility is exited. From then on, use your own administrator account to
perform Admin tasks.
When a new System Administrator account is setup, the Administrator can select the
Administrator tile to define system preferences, policies, User management, and as needed,
perform Hardware Maintenance, such as Base Station and Logger firmware upgrades.
In this Chapter:
• Start the program and log in to the ValProbe RT software using the default System
Administrator account.
• Select security and Log-in authentication mode; Local security and Users or Active
Directory
™* (LDAP).
• Set System Policies
• Create System Administrator account (local / Active Directory
• Utilize User Management to create other User accounts. (local / Active Directory
• Set Preferences
• Utilize Hardware Maintenance to upgrade Logger and Base Station firmware for future
upgrades.
• Access ValProbe RT online help
™*)
™*)
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4.2. Initial Log in as a Default System Administrator
When the Console is initially powered on, it automatically boots into the Kaye Operator
Windows account. Inside the Start Menu, navigate to, and start the ValProbe RT software, the
Login screen appears as displayed below:
Figure 52: Login Screen
Enter the one time default User ID“Kaye” in the User ID textbox.
Note: “Kaye” is the default System Administrator User ID, and the User ID textbox is case
sensitive. Please ensure that the default User ID is entered exactly as it appears above.
Enter the one-time default System Administrator password “411” in the Password textbox.
IMPORTANT: The default User ID and password are as follows, “Kaye” and “411”
respectively.
Select Login.
Once logged in, the Policies screen opens.
The Policies screen is used to define if the Security and sign in for the ValProbe RT software
utilizes Active Directory
™* for sign in or the local security and policies of the ValProbe RT
software.
If utilizing Local Security and Policies proceed to Section 4.2.1. If planning to utilize Active
Directory™* proceed to Section 4.2.2.
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Setting Up Initial Administrator using Local Security and
Policies
When the Initial default User ID and Password are entered, the system automatically
opens the Policy screen and defaults to Local security and policies.
Ensure that Active Directory* Connected displays NO. If not, select ActiveDirectory
User button to toggle Off Active Directory*.
Figure 53: Login Screen
In the policies window define the local security and 21 CFR Part 11 options to meet your
security needs. The options include:
• Set passwords to expire after a defined number of days: Use the dropdown list to select
how long to passwords take to expire. The password expiration date set here is
displayed at login when there are five days or less before password expiration. Expired
passwords can no longer be used as new passwords.
• Disable user accounts after a certain amount of unsuccessful login attempts: Check the
checkbox to enable and set the amount of consecutive unsuccessful login attempts to
disable a user account with the dropdown. Only System Administrators can re-enable
Users
• Disable user id during entry: Check the checkbox to enable masking of the user ID
during login.
• Disable the password system: Check the checkbox to disable the password system,
meaning user ID’s and passwords are not required to use the software. Only allow by
Admin and documented in the Audit Trail
• Require Special Characters:
Additional options as part of Policies include:
• Syncin User before Auto Sync Out: If enabled Users will be automatically Synced
In from backup prior to automatic Sync Out. This can automate control of ensuring
all Console have same Users
Once the Local Policies have been defined select “Save” and then proceed to the User
Management screen to define a Local Administrator.
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Define a System Administrator to replace the Default Kaye account. For the replacement
Administrator, the New User window opens automatically.
Figure 54: User Management Screen
Note: Red asterisks fields are mandatory: User IDs are unique, and the passwords must
follow the default rules for passwords (minimum of six characters).
Enter a User ID in the User ID textbox.
Note: A User ID can use any combination of numbers and characters, up to a maximum of 75
and a User ID cannot be used by more than one account.
Enter a password in the Password textbox, a password must be at least a combination of
six characters or numbers, up to a maximum of 16. It is recommended for security to use
more than six.
In the Confirm Password field, enter the password and select OK.
Record the new Administrator User ID and password for future reference. If an incorrect User
ID/password combination is entered, access is denied. After the initial administrator account is
created, the default “Kaye” “411” login credentials are automatically deleted.
For the initial system administrator, the User Type and User privileges are preset. Enter a title,
phone, email, and associate a picture by using the built-in camera. After completing the
system administrator User setup, the system logs out. To proceed, open the software, and log
in with the new Administrator account information.
To return to the User Management screen to add additional Administrators or Users, select the
Admin tile.
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Setting Up Initial Administrator using Active Director
Security and Policies
Kaye ValProbe RT has built in Active Directory™* system support. You can connect your
company’s users in your Active Directory™* with the ValProbe Rt system, allowing more
freedom to handle user management. To set up initial Active Directory™* security and
policies, follow the instructions below:
Note: To set up Active Directory™*, you must be an administrator with read rights to read
your company’s Active Directory™*.
Note: The ValProbe RT software is only able to connect to one company’s Active
Directory™* at a time.
At the initial Login Screen, enter “Kaye” in the User ID textbox.
Note: “Kaye” is the default System Administrator User ID, and the User ID textbox is case
sensitive. Please ensure that the default User ID is entered exactly as it appears above.
Enter the one-time default System Administrator password “411” in the Password textbox,
the Policies screen opens.
Figure 55: Policies Screen
To enable the utilization of Active Directory™*, ensure the ValProbe RT console is
connected to the domain and select the ActiveDirectory User box. A window appears to
define User Credential and Domain connectivity parameters.
Figure 56: Active Directory* Credentials
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(LDAP - “Lightweight Directory Access Protocol”, is a software protocol that stores and
arranges data to make it easily searchable. Microsoft uses this for their Active Directory™*
system.)
Enter your Administrator User ID and Password provided by your company in the
designated boxes.
Enter your company’s Domain Name, contact your IT department if you require
assistance getting the correct domain name.
Using the dropdown select the Authentication Type, contact your IT department if you
require assistance getting the correct authentication type.
Enter the Port number to connect to your Active Directory*, contact your IT department if
you require assistance getting the correct port number.
When completed press Connect. If communication with the domain was successful,
ActiveDirectory Connected displays Yes. If connection failed, contact your IT department,
and retry.
Figure 57: Active Directory* Connected
If desired, select Allow Guest Login to allow any Active Directory™* users that are not
members of configured groups to login with the selected privileges
Once the Active Directory™* parameters have been defined and connection has been
established, select Save to save settings.
Note: With Active Directory™* enabled, all local security policies are greyed out as all
security policies follow company domain policies.
Proceed to the User Management screen to define Administrator Active Directory™*
Groups and permissions.
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Figure 58: Sync In Active Directory* Users and Policies
The Active Directory* setup window has a feature that allows locally saved policies,
parameters, and User Management definition to be Synced-In to other ValProbe RT Consoles
to avoid having to reconfigure them individually. From the Console with the configured Policies
and User Management, open the Main screen>File Management>SyncOut. Define the path
(USB, Folder on Domain) and then select Users>Audit>SyncOut. On the other ValProbe RT
Console, open the Admin>Policies screen and enter the path where the Users and Audit were
stored and select SyncIn.
Figure 59: Active Directory User Management Screen
If the Active Directory™* configuration and connection were successfully established in the
Policies screen, when entering the User Management screen, a complete list of all active
Groups within the defined domain is displayed.
Important: Prior to defining the User Management screen, it is necessary for the Validation
Manager to work with their IT department to define and configure on the defined
domain, the various Groups and people within each group who need access to the
ValProbe RT system. Each Group can be assigned a User Type which defines
what permissions are granted for each member of the group.
Important: For the ValProbe RT system to operate their must always be an Administrator
defined group. Upon first time startup of the system, the Administrator must define
and set permissions for an Administrator Group. Once completed the Default User
ID and Password are deleted and the system reboots.
To map the predefined Administrator Group:
Select the domain group to assign as Administrators. In the Title box use the dropdown to
define the User title. If the desired title is not listed, press Select and type in the desired
title, the title appears in the active group users listed below the Username.
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In the User Type box, use the dropdown to select System Administrator. The Default
Users Privileges appear.
Select Save once completed the Default User ID and Password is deleted and the
complete Policies and User Management configuration is saved locally to the console to
allows Users to still utilize Active Directory™* login even when not connected to the
domain the system then reboots.
Log in using the Administrator password and proceed to User Management to map other
User groups.
Adding / Managing User Accounts – Local Security
When logged in with a new system administrator account, additional Users may be added to
the system. The software supports up to 500 Users.
Note: It is recommended to create more than one System Administrator account if access to
one is lost.
To create a new or additional System Administrator account:
On the Main screen, select the Admin tile to open the Admin Settings window.
From the Admin Settings window, select User Management.
On the User Management screen, select New User, and enter the User’s name in the
Name textbox. This Username appears in the active User list.
Figure 60: User Management Screen
Use the dropdown to select your desired Authentication Type, if you do not know it,
contact your IT department.
Note: User IDs must be unique. Once a User ID has been used, it cannot be used again or
used by more than one active account.
Enter a new System Administrator/User password in the Password textbox. Passwords
are 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.
Reenter the password in the Confirm Password textbox and select OK.
Note: Please record the User ID and password for future reference.
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Optionally, you may enter a designated Phone number and Email ID as contact details
that are for contact information only. Select Save to save the information.
The User Management screen displays a list of active Administrators accounts. The default
Administrator Kaye account is deleted.
Only Administrator accounts can enter the admin tile and create new Operator accounts.
Unlike Administrator level accounts, an Operator account is added by the Administrator it is
assigned a temporary password which will be required to be changed by the Operator when
they first login. When creating a new Operator account, the Username is added to the active
User list. To create an Operator account:
Enter a new Username in the Name textbox.
Note: User IDs must be unique. Once a User ID has been used, it cannot be used again.
There is a limit of 500 Users, creation of a 501
st
User causes a warning message to
appear and does not allow any further User creation.
Enter the new account’s User identification in the User ID textbox.
User IDs are any combination of numbers and characters. The User ID and password
are case sensitive. A User ID may not be used by more than one account.
Enter a temporary password for the User in the Password textbox.
The temporary password is any combination of numbers and characters. The User must
change this password on their first ValProbe RT software login.
Enter the temporary password again into the Confirm Password textbox.
Note: Please record the new User ID and temporary password.
Note: A User account is not active until the User changes their temporary password after
logging in for the first time.
Define the Title.
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Select the User Type dropdown to select from previously created user types or create a
new User Type by typing in a new name over the previously created one in the dropdown.
Select which privileges to add or remove for the new User type by selecting or deselecting
the checkboxes and select Save. To return to the User management screen and not save
your changes, select the black X or Cancel.
Figure 61: Default User Privileges Window
Once saved, the new User Type is displayed in the User Type dropdown on the User
Management screen.
Deleting and Disabling Local Security User Accounts
There are two additional states for a User:
Disabled User
A User may be disabled by an Administrator or automatically disabled after a certain amount
of consecutive login failures (3-10) if enabled in Policies (see Section 4.2 for details). A
disabled User account is marked in red in the User list. The disabled state is set with the
checkbox Disabled User Account in User Information. An Administrator can re-enable the User
account by unchecking Disabled User Account checkbox.
Deleted User
If a user account needs to be removed, an Administrator can delete it by selecting Delete at
the bottom of the screen. To prevent discrepancies in the audit trail, the deleted User ID is
blocked for further usage. The deleted User is removed from the User list, but the User’s
information remains accessible via the User list printout.
Users List
The Users List generates a .pdf report that lists all active, disabled, and deleted User
information.
User Search
A search field that filters for Username. As an example, if “B” is entered all usernames starting
with “B” are listed.
Note: All Users are listed in alphabetic order.
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Local Security - One Time Emergency Access
It is good practice to establish more than one active Administrator account, if a system
administrator is unavailable the system is still maintained. If administrator access is not
possible, Kaye can provide a one-time Emergency access with the sole purpose of modifying
an Administrator account. For this procedure, direct support from Kaye service is required.
To start the emergency login, open the Login screen and enter “Ctrl+e” into the password field.
Please contact Kaye Support directly to receive required information. All emergency access is
logged in the audit trail.
Figure 62: Authentication Types
Adding / Managing User Accounts – Active Directory™*
To add / modify additional groups and privileges in your company’s Active Directory™* do the
following:
Define within your Active Directory™* company domain the desired Users and Groups for
the ValProbe RT system.
From the User Management screen, select the dropdown list under User List to display all
groups in your company’s Active Directory™*.
Figure 63: Active Directory* Groups
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Select the desired group from your defined company domain.
Select or type the Title for the group.
Select the User Type dropdown.
Figure 64: Default User Privileges Window
Use the User Type dropdown to select from previously created user types or create a new
User Type by typing in a new name over the previously created one in the dropdown.
Select which privileges to add or remove for the new User type by selecting or deselecting
the checkboxes and select Save. To return to the User management screen and not save
your changes, select X or Cancel.
Once saved, the new User Type is displayed in the User Type dropdown on the User
Management screen.
Note: If a user is in multiple Active Directory™* groups and there are changes to their user
type in multiple groups, the last group updated is saved. For example, if a User is in
both group A and group B as an operator user type, and someone makes a change for
that user in group B, for example, to make them a System Administrator, they become
a System Administrator in both groups.
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4.3. Setting Preferences
Figure 65: Preferences Tab in Administrator Menu
Changing system Preferences is an Administrator task and requires an Administrator account
to edit the above defaults. Any edited settings become effective immediately after selecting the
Save button. The following preferences are available to be set:
• Company Name: Enter a company name to display in report headers.
• Temperature: Temperature units are set to Celsius only. All calculations are performed in the
temperature unit specified here.
• Max Groups: Use the dropdown to select a maximum number of groups for a setup.
• Line Frequency: Use the dropdown to select a line frequency, 60 Hertz or 50 Hertz depending
on your environment.
• Pressure: Use the dropdown to select the absolute pressure units for saturated steam
calculations.
• Alternative Machine ID: If required, enter an alternate machine identification number, which
appears in the audit trail as additional identification.
• Instrument calibration warning: Sends a user a warning after a set amount of time, using the
dropdown, when calibration is required.
• Allow editing of D value in lethality equation: Allows the user to edit the D value in the
lethality equation.
• Allow Users to change Lethality: Use the dropdown to decide if the User should be able to
change lethality, Yes or No.
• IRTD Stability Threshold Lower Limit: Enter the lower limit for IRTD stability (from 250 to
400°C or 482 to 750°F). The IRTD stability is fixed to 0.012°C, but for high temperatures which
threshold limit is set with this value, or temperatures below 0°C, the IRTD stability value
becomes editable in the setup.
• Mandatory User Comments in Audit Trail: When enabled/checked, user comments are
mandated when user credentials are validated to log the audit entries.
• Logo: Select Change to browse to a location to add a logo to display in report headers. Use any
bitmap for the graphic, with a preferable size of 90 x 30 pixels. Other formats are downsized.
• Logger Battery Warning Threshold: Set at what battery percentage a warning displays, default
is 10% and can be set between10%-40%.
• Report Footer: Set if signature fields are applied on the first/last/every page for Setup and
Sensor Verification reports. Note, this is set directly in the reporting tool for qualification reports
such as Detailed, Summary, and Pass / Fail.
• Data Directory: Displays the path and folder of the Data Directory.
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4.4. Hardware Maintenance
The Hardware Maintenance screen allows the Administrator the ability to upgrade the Base
Station and Logger Firmware whenever desired upgrades are released from Kaye. This
eliminates the need to have to return the Loggers and Base Station to the factory when
desired upgrades become available.
All upgrades are posted on the Kaye website for download to a USB drive or computer. Use a
USB inserted into a Console Docking Station to install the upgrade, or if downloading to a PC,
use tools such as Remote Access to connect to the Validation Console and copy the files from
a PC to the Console.
Note: Refer to release notes and instructions provided with the appropriate upgrade
download.
Note: Firmware upgrades usually include both the Base Station firmware and associated
Logger firmware. It is recommended to perform the Base Station firmware upgrade prior
to upgrading the Logger firmware.
Figure 66: Hardware Maintenance
BS Firmware Upgrade:
From the Admin / Hardware Maintenance screen, select BS Firmware Upgrade and
select OK.
Ensure that the Base Station is properly connected and powered on.
From the Select Base Station screen select the desired Base Station to upgrade and
select Connect.
Logger Firmware Upgrade:
From the Admin / Hardware Maintenance screen, select Logger Firmware Upgrade and
select OK.
Ensure that the Base Station is properly connected and powered on.
From the Select Base Station screen, select the desired Base Station and select Connect.
Wake up and select Loggers to be upgraded.
Logger Battery Reset: Select this option to reset the Logger batter and select OK.
Contact Kaye technical support for additional assistance or instructions.
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RH Sensor Information Screen
The ValProbe RT Temp / Humidity Logger has a digital T/H sensor with its own serial number.
The Logger and sensor work as unit and are excluded from qualification studies if the sensor
serial doesn’t match the serial number stored in the Logger memory. The Logger and sensor
serial numbers can be verified in the RH Sensors Screen to correct mismatches that could
happen e.g., after use of extension cables were loggers and sensors were accidentally
changed.
Figure 67: RH Sensor Information
Opening a Logger and Connecting an Extension Cable
Unscrew the PTFE filter cap (rotate counterclockwise).
Figure 68: Unscrewing the Filter Cap
Remove the sensor module, rotate counterclockwise as per the figure below.
Figure 69: Removing the Sensor Module
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Note the serial number which is listed below the black material.
Figure 70: Sensor Serial Number
Plug the extension cable into the Logger where the sensor module was removed.
Connect the sensor module to the other end of the extension cable. Before proceeding,
verify the serial number of the sensor is the same as Step 3.
Figure 71: Extension Cable Connected
When finished with the extension cable, remove the cable, and then secure the PTFE filter
cap, rotate clockwise to tighten.
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Show Compatible Versions List
From the Admin / Hardware Maintenance screen, select Show Compatible Versions List
and select OK.
A window opens displaying the firmware versions of the software, Base Station, and
Loggers.
Figure 72: Show Compatible Versions List
Select X to close the window.
4.5. Online Help
To display online help, swipe from the bottom or top edge for the app commands. There are
two icons with a question mark, labeled as Windows Help and Help. Windows Help displays
the help screen of the operating system; Help displays context-specific help for the open
ValProbe RT application screen.
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Chapter 5: File Management
Chapter 5. File Management
5.1. Overview
As a dedicated validation system, the ValProbe RT system is responsible for the collection,
reporting and storage of GxP files related to Thermal Validation studies. Data which is
collected by the ValProbe RT system is stored locally as raw encrypted data files along with
.pdf files of the reports used for analysis.
To meet Data Integrity, and 21 CFR Part 11 requirements, Kaye has designed the ValProbe
RT Console / software with the following features to protect data stored in the Console /
software:
• Dedicated Console and core load with only programs necessary to perform validation
activities (no internet access, e-mails, Microsoft office).
• Restricted access to modify or delete files/ date-time using Windows 10 LTSC OS and
permission rights for Operators.
• Ability for IT to download Virus protection programs and perform manual patches of OS.
• File Management tools which include the ability to Sync Out / Sync In and Archive all
data to defined paths such as share folder and mapped drives on the Domain.
The sync functions are used for a backup but also to merge the data of several console’s data
sets following some rules for merging:
• Preferences and policies are not synchronized.
• If two items with the same name exist, the item is updated with the latest version
(depending on the modified date) for Users and assets. If two items have the same
name but different dates (reports, study files), both are retained.
Sync operations are manually generated and started from the File Management tile on the
Main screen. Access to the File Management feature is controlled by User privileges defined
in User Management.
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Sync Out
The Sync out function is used to copy the data content of the console to another User defined
file location. If the content of one console is copied to a dedicated folder, it serves as a backup
function.
If the data of two or more consoles synchronizes to the same folder, the data is merged
together to build up a pool of shared data for a work group. Data that is sync’d out to the
master folder is appended to existing data. Only files which are not already present on the
current master folder are copied.
Figure 73: Sync Out
To perform the Sync Out function, select Sync Out. In the pop-up box enter the path to Sync
to. To simplify selection, select the Browse button to view all drives and folders. When
completed select OK.
Figure 74: Sync Out Data Selection
The Data selection screen displays and specifies the data to Sync Out. Data selections include:
• Current Users and privileges from User Management
• Audit Trail
• Equipment including Logger Sensor Verification files
• Pass-Fail Criteria Templates
• Desired Assets (includes Setups, Qualifications, Reports, and Documents)
Select OK when all selections have been completed. Unless there are existing folders,
separate folders are automatically created for the different choices of data. As required, Sync
Out additional folders.
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Sync In
The Sync In function copies data from a file location to the console. Sync In is used to restore
data from a backup generated with the Sync Out or Archive function. Like 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 is a date filter to specify a data range to allow more
selectivity on the data copied to the console. The date filter specifies a timeframe with a
dropdown selection.
Figure 75: Sync In
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 may be selected
individually.
If selecting a folder with existing sync data as target, the copied data is merged with the
existing console data.
Note: It is recommended to use a separate folder for archived data, otherwise the data syncs
back to the system.
Figure 76: Archive
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ValProbe RT Convert
The ValProbe RT Convert function imports single study files into the Asset system of the
console. Single study files may be copied to a disk from Asset details to import into another
console or sent 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.
Select a single data file in the browser, add a comment for easier identification if needed. If the
corresponding asset is not in the system, the software creates a new asset and setup file from
the information stored in the study file.
Note: If a Study file from an existing asset is selected, it merges the study file with the existing
files into the asset without duplicates.
Figure 77: ValProbe RT Convert
5.2. Using Mapped Drives for Sync Functions
The synchronization function is used to share data via a mapped drive to a server. Ensure that
the mapped drive is correctly mapped in the Windows console. Note the following to ensure
synchronization performs properly:
It is recommended to enter the server address as a plain IP address; a server name may not
work.
It is possible to use subfolders inside the mapped drive.
The system requires the service MappedDriveHost running in the background for sync
operations.
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Figure 78: Windows – Mapping a Drive
When syncing from the software to a mapped location using the ValProbe RT software:
Browse to the mapped drive. It 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 proper credentials for accessing the drive. When using a domain for security, add the
domain information after the Username with an @ extension as displayed in the figure below
(alternatively, the domain\User format is accepted).
Figure 79: Mapped Drive Login Credentials
The security setup to access a shared folder is dependent on each network environment.
There are several scenarios:
If the folder is accessible without restrictions, enter a random User and password, as empty
fields are not accepted. The random User and password are not used and discarded.
If the folder has User restrictions, enter proper User credentials to access the folder.
If the folder has a domain security policy. Enter the domain after the Username with an @
separating the Username and password. Some domains do not accept this type of
authentication and may require joining the console to the domain which copies all domain
security policies and Users to the console. Please contact your IT department for further
support.
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Chapter 6: Equipment
Chapter 6. Equipment
The ValProbe RT includes a unique feature called "Equipment". Equipment is accessed from
the Main Menu, by selecting the Equipment tile. Equipment provides the User with a tool that
assists in tracking their Kaye calibration and verification data associated with their ValProbe
RT Loggers, IRTD’s and Temperature References. The Equipment tile is the take off point for
performing Sensor Verifications for all ValProbe RT Loggers and sensors.
Figure 80: Equipment Tile
6.1. Equipment Assets
Select the Equipment tile on the Main screen, to open the Equipment Assets screen. The
Equipment Assets screen displays all equipment connected or manually created (i.e., five
VPRT Loggers, one Calibration Bath, and two IRTD’s) to the system.
Note: The ValProbe Logger tile has an option to Initiate Verification to perform periodic pre
and post Sensor Verifications of Loggers. A detailed explanation on Sensor Verification
capabilities and processes is highlighted in Chapter 11.
Figure 81: Equipment Asset display
• Kaye equipment Assets are automatically created the first time the equipment is
connected to the ValProbe RT system.
• Additional Kaye equipment or non-Kaye equipment can be manually added to the
Equipment Asset list.
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Chapter 6: Equipment
Manually Adding Equipment Assets
To add a new piece of equipment inside Equipment assets, select the Plus (+) icon on
Equipment screen. The New Equipment screen opens.
Figure 82: New Equipment Screen
Use textboxes and dropdown menus to enter the following:
• The equipment serial number as a unique identifier
• Last calibrated date
• Model number
• Equipment type
• Calibration due date
To upload an image of the equipment, browse for a bmp or jpeg or access the camera to take
a picture directly.
When finished, select Save to save the entry and return to the Equipment screen or Cancel to
reset entries on the screen.
Equipment Contents
To view the Equipment tile contents for a specific piece of equipment (i.e Logger), from the
Equipment Asset screen select the VRT Logger tile.
Figure 83: Equipment Assets
The software then displays five VPRT Loggers, each tile contains the serial number of the
Logger, the Logger type, the manufacturing Calibration date, and the Manufacturing Cal Due
date. Select the desired Logger.
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Figure 84: VRT Loggers
The Logger tile lists all available Sensor Verification study files including, the setup name,
date, run number, and comments. After selecting a study file, Generate Report or select the
blue Reports tile and a previously generated Verification .pdf report.
Figure 85: Logger Contents
Select the blue Documents tile to upload documents such as Logger manufacturing
Calibration certificate for storage and easy access.
6.2. Calibration Reminder
The Equipment tile includes a Calibration reminder and alert for all equipment.
To use the calibration reminder, activate and set the calibration reminder timeframe in the
Admin / Policies. The reminder timeframe specifies the number of months ahead of the
Calibration due date a User is alerted. When the equipment calibration due date is within the
calibration warning timeframe, the software alerts the User by:
• Inside the Equipment tile on the Main screen: a number corresponding to the number of
equipment due for calibration displays.
• Opening Equipment: the tiles for any equipment due for calibration are enlarged in light
blue and display the calibration due date directly within the tile.
• When equipment is recalibrated: the User is required to manually update the calibration
data and due date.
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Chapter 7: Defining Assets
Chapter 7. Defining Assets
7.1. Overview
The ValProbe RT includes an intuitive Asset Centric Data Management concept (patent
pending) to store and access data faster and more efficiently.
Each individual validation process, whether a sterilizer, freeze dryer, cold room etc. may be
set and defined as an asset. All files and data related to the asset, like setups, calibrations, or
study files, are organized and accessed in one single screen around the basic asset data. It is
possible to upload additional documents like standard operation procedures or certificates and
associate them with an asset. Assets are sortable and searchable by type, location,
manufacturer, etc. for easy access. A maximum of 200 assets may be defined.
To open the Assets hub, select the Assets tile on the Main Menu. The Assets Hub appears as
below.
Figure 86: Assets Hub
The Asset Hub lists the various assets validated by the ValProbe RT system. On the top text
line, select each category to display the assets by:
• Type (sterilizer, dry heat oven, controlled temperature, etc.) up to 20 User-designated
types
• Manufacturer
• Location
The asset tiles display each asset with its Asset type, Asset ID, and Asset name. If the number
of assets exceeds the screen size, scrolling and zooming enables viewing additional assets.
To search for an asset, select the Search (magnifying glass) icon, and enter search criteria /
data.
For further details regarding a particular asset, select the tile for that asset to open its Asset
Details window.
To add one or more assets to the list, select the Plus icon (+) to open the New Asset creation
window. Select the Back icon (the left arrow) to return to the Main screen.
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7.2. Asset Details Screen
To learn more about an asset, select its asset tile to open the Asset Details screen (displayed
below).
Figure 87: Asset Details
In the upper left, the asset type and name is listed as the Title. The pane on the left displays
up to three User-loaded photos (swipe to change to the next picture) of the asset, and lists the
asset information as entered with the following data:
• Asset ID: The internal asset number or serial number for unique identification.
• Manufacturer: Manufacturer name of the asset
• Type: Categorization of the asset
• Model: A model name or subtype can be specified
• Last validated: Date of the last validation as manually entered in the Edit Asset screen.
The action buttons in the upper right corner allow editing of the asset details (pencil) and the
ability to delete the asset from the system (trash bin). In that case all associated files needs to
be deleted manually before the system allows deleting the asset.
Note: All available actions within each tile are controlled by the privileges assigned to the
logged in User account. All actions are logged into the Audit Trail
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. This is useful if there are
multiple chambers of the same type.
Figure 88: Copy Asset
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The Asset screen also contains separate blue tiles for Setups, Qualifications, Reports, and
Documents.
The number on each tile represents the number of available files under this specific tile. Select
a tile, and the lower right window displays the list of related data as well as the actions
available to perform from this tile.
Note: All available actions within each tile are controlled by the privileges assigned to the
logged in User account. All actions are logged into the Audit Trail
Setup
Selecting the Setup tile displays a listing of all available Setups for the Asset. A scroll bar to
the right will be displayed to allow access to all Setups.
Figure 89: Setup Tile
The Setup file contains all the configuration information to define sensors, groups, wiring
diagram, calculations, and qualification parameters which define the requirements for the
validation study.
For every Setup listed the following buttons are available:
• Pencil: Permits editing an existing setup and saving under the same or new name.
• Wiring Map: Permits reviewing of the sensors wiring diagram and exporting them to a
.pdf. Wiring diagrams are created inside the setup when defining the groups.
• Print: Permits exporting a setup report including the wire diagram to a .pdf file.
• Delete: Permits deletion of a setup (privileges required).
The New (+) button creates a new setup, and it is also possible to copy existing setups from
other assets as templates.
The Copy button opens a list of all available setups on the console. Assets are listed by their
names and setup names, number of sensors, comments, and last modification date. Select
setups to copy to the Asset and select Copy.
Use Copy to Drive to copy the selected setup file to a chosen drive. This is primarily used for
service as requested Setup files are copied to a USB and then sent to Technical Support for
review.
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The Initiate Qualification button is used to initiate the Qualification process. Firstly, select the
desired Setup file and then select the Initiate Qualification button. Selecting this button starts
a qualification process. The Hardware Discovery screen displays, and the setup is transferred
to the selected ValProbe RT.
Qualification
Selecting the Qualification tile displays a listing of all available Qualification files that have
been saved. A scroll bar displays for access to all Qualifications.
Figure 90: Qualification Tile
The Qualification files contain all the collected raw encrypted data gathered during the
Qualification study. The Qualification file names are the names of the Setup used along with
the date they were performed.
If the Logged in User has the proper permission rights a Delete button is available to delete
the Qualification file.
Use Copy to Drive to copy the selected Qualification file to a chosen drive. This is primarily
used for service as requested Qualification files are copied and then sent to Technical Support
for review.
The Generate Reports button is used to initiate the selection and generation of reports for the
Qualification file. Firstly, select the desired Qualification file and then select the Initiate
Qualification button.
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Reports
Any reports which have been generated from a Qualification file are automatically stored as
.pdf files under the Report tile for easy access and viewing. The reports are sorted and listed
by report types; Setup, Qualification, and Pass / Fail. Selecting one of the report types
provides a listing of all the available .pdf reports. A scroll bar to the right may be used to
access additional reports of the selected type.
Figure 91: Report Tile
The blue circle to the right of the Qualification file names, represent whether the report is a
Detailed or Summary report.
For every report listed the following buttons are available:
• Pdf icon: Permits viewing or printing of the .pdf report.
• Delete: Permits deletion of a .pdf report (privileges required).
Use Copy to Drive to copy the selected .pdf report to a chosen drive.
For documents, the Document pane provides options to upload any .pdf files related to the
asset, e.g., wiring diagrams, SOPs, or calibration certificates.
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Documents
The Documents tile provides the ability to upload external documents, pictures, word, or .pdf
documents, to store as part of an Asset. These can include Manuals, SOP’s, Protocols,
Diagrams, etc.
Selecting the Documents tile provides a list of all uploaded documents. Use the scroll bar to
the right to scroll through any additional documents.
Figure 92: Documents Tile
For every document listed the following buttons are available:
• Pdf icon: Permits viewing or printing of the selected document.
• Delete: Permits deletion of a .pdf report (privileges required).
Use Copy to Drive to copy the selected document to a chosen drive.
Use the Upload Documents button to browse to the source of the desired document.
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7.3. Creating A New Asset
To enter a new asset into the ValProbe RT system, go to the Asset Hub screen and select the
Plus (+) icon. The New Asset screen opens.
Figure 93: New Asset Screen
Enter each new asset details separately, use the textboxes and dropdowns to enter:
Note: All fields highlighted with an asterisk are required fields to allow sorting of Assets.
• Name: Asset names must be unique. Before synchronizing several asset data sets, it is
recommended to ensure there are no duplicate asset names utilized.
• Asset ID: This field is used to specify a company asset number or ID.
• Type: Select an existing asset type or enter a new type. Any new type definition will be
available in the dropdown in the future.
• Manufacturer: Specify the manufacturers name of the asset.
• Location: Specify the location of the asset. This could represent the building or
department.
• Model: Specifies the model number of the asset. This field is optional.
• Size: Specifies the volume of the asset in cubic units. In the dropdown, it is possible to
select the appropriate units or enter custom units. This field is optional.
• Last Validated: Specifies the date of the last validation of the asset. This field is
optional.
• Validation frequency: Specify the required validation frequency. This field is optional.
Enter an optional Description of the asset located on the right. Up to three images may be
uploaded to appear on the Asset Details screen, as well as a wiring layout image(s) to provide
Users with sensor placement details. Alternatively, utilize the camera to take pictures.
Select Save to save the entry and return to the Asset Hub.
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Chapter 8. Defining Study Setups
Before running a qualification study, 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, permissions must be established and given by the System
Administrator in the Admin menu (User Management tab).
Setups are accessed from the Asset Details screen, through the Setup pane. When creating a
setup:
• Define the number and type of sensors to use in the study
• Assign sensors to groups and generate a wiring diagram
• Specify calculations to be monitored during qualification study
• Specify start and stop conditions for qualification
• Specify Logger Sample Rate, Transmission Rate, and RF Transit Threshold
When the setup is created and saved, a qualification study is ready to run.
8.1. Initiating a New Setup
Figure 94: Setup Hub Screen
From the Asset Details screen, select Setups to open the Setup Pane Hub. Select New to
open the Study Details screen.
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8.2. Define Setup Screen
Use the Define Setup screen to define descriptive information detailing a Setup. The screen
header lists the name of the new setup and six separate boxes signifying the steps or screens
to complete the Setup.
Figure 95: Define Setup Screen
Use the textboxes or dropdowns 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.
The Setup Name and Comment fields accept alphanumeric characters and spaces; the Load
Description and SOP fields can also include special characters (spaces,-,_,.,?,/,and \).
When all asset data is entered, select Sensors Configuration to continue.
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8.3. Sensors Configuration Screen
From the Asset Details screen, select Sensors Configuration to open the Sensors
Configuration screen.
Figure 96: Sensors Configuration Screen
The Sensors Configuration screen permits the User to define the number and type of sensors
to be used, as well as labels and descriptions for each defined sensor
The Sensor Configuration process is two steps:
• Add Sensors
• Configure Sensors
Note: Sensor Configuration defines the number and type of sensors intended to be used for
the study. The serial numbers of the actual Loggers and sensors are not defined in the
Setup but rather defined just prior to starting a Qualification.
Select the Down Arrow to open the Add Sensors window. For each type of sensor, define the
intended number of sensors for use. Select Add to add sensors, they newly added sensors
appear as blue tiles for each type of sensor defined (Temp, Pressure).
Select the Down Arrow to open the Configure Sensors window. For example, to select a
series of humidity sensors:
• Select Humidity from the Sensor Type dropdown.
• Defined the consecutive range of sensors to configure.
• If desired, modify the Sensor Label and define the sensor number to begin with when
Auto numbering.
• Select Assign and all selected sensors will be assigned and have the defined labels.
Repeat the procedure for Pressure or Temperature if defined.
To individually select sensors, select each sensor tile, then select the type of sensor, label,
and number. Select Assign to complete configuration of sensor.
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Figure 97: Configure Sensors
Select the Description button to open the Sensors Description screen. On this screen all
sensors are listed in a table, along with information entered during sensor configuration.
Figure 98: Sensor Description
To define descriptions, select the sensor type to display that type of sensor. Select a single
sensor or multiple sensors from the table. Enter descriptions in the Description textbox and
select OK to save the description or Close to cancel. Use the Clear button to clear all. Use the
Auto Numbering checkbox to enable autonumbering to the sensor description. To return to
the Sensors Configuration screen select the red X in the upper right corner.
Select the Group Sensors tab to advance to the next screen.
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8.4. Understanding Groups
Grouping sensors is a powerful analysis tool to utilize for validation studies.
The following rules apply when assigning groups:
There must be at least one group defined in a setup. Each group must have a unique
name.
Groups should be homogeneous (similar sensor types) since calculations are
performed on all the sensors.
Assign a sensor to more than one group.
Sensors do not have to be in consecutive locations. Assign any sensor from any Logger
to a group.
As long there is no group defined, the Default Group button automatically generates
groups for sensors with the same measured variable, like temperature and pressure.
To record data from a sensor, it must be assigned to a group. Any sensor not assigned
to a group is considered unused and no data is recorded for that sensor.
• Each group can have unique header information.
• Each group can have a separate sensor layout image.
• Assigned calculations are applied for each group of sensors
• Qualification reports include unique pages for each group.
Grouping Examples:
• Using separate Distribution and Penetration sensor groups to analyze a sterilizer study.
• Using separate groups for each shelf of a freeze dryer to determine temperature
variance and having all sensors from all shelfs in a separate group for analysis.
• Utilize groups to perform validation of four separate freezers at the same time each
containing 12 sensors.
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8.5. Assigning Sensors to Groups
Figure 99: Group Sensors Screen
When the sensors are configured, the next step is to group the sensors by selecting Group
Sensors. The Group Sensors screen displays a scrollable listing of existing groups and the
New Group button.
To assign sensors to groups:
• Select the New Group button, to open the Group Name textbox. The Group Name textbox
accepts upper- and lower-case characters, numeric characters, special characters like
hyphens, underscores, slashes (forward and backward), and spaces.
• Enter a name for the group and select Enter
• Select individual sensors to add them to the group. These sensors appear deep blue with an
orange checkbox on screen.
• If desired, customize the header for each group: The group specific header fields are prepopulated with the information from the asset. Use the Save button before switching to
another group to save changes.
The screen has the following options:
• Delete: delete a group of sensors.
• Customized Header: the group specific header fields Asset ID prepopulates from the
Asset and the SOP number prepopulates from the Define setup screen. The header is
customizable for each group. Select Save before switching to another group to save any
changes to the header.
• Edit Group: select the Pen icon inside the Group name to edit the group.
• Add Sensors: add additional sensors to a group.
• Wiring Layout: accessible via the Book icon, enables wiring layout configuration.
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Figure 100: Wiring Layout Diagram
Using the wiring layout diagram, define up to five pictures as a background when positioning
sensors. Select a picture frame on the right side of the screen and load a picture from a file
using the Pen icon or Camera icon to take a picture with the built-in camera. Use the Trash
icon to delete pictures.
Note: Take pictures by selecting the Camera icon through the device camera. Ensure that
the software can access the camera. The picture can be taken by pressing the camera
icon through the device camera.
Sensor tags are movable, via drag and drop, to a position reflecting their position on the asset.
Use the Printer button to export the Wiring diagram into a .pdf.
For every group, select a picture and a sensor position, then save it along with the setup. The
wiring diagram is printed from the Wiring Layout screen or as a part of the Setup report directly
from the Asset Details screen. The wiring diagram is used in Layout View during Qualification
to provide live data.
To clear a sensor, select the sensor label and then select Clear Sensor.
When finished, select Calculations to proceed to the Calculations screen.
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8.6. Specifying Calculations
Figure 101: Calculations
With sensors defined and assigned to one or more groups, calculations must be specified for
all sensor groups during the qualification study. Calculations include, Statistical, Lethality,
Saturation pressure of steam, and Saturation temperature of steam calculations.
Statistical
The Statistical Calculations are automatically generated and include Min, Max, Max and Min
Sensor Label, Max-Min, Avg and Standard Deviation, Max–Avg, Avg-Min, and Cycle Time.
Lethality
Figure 102: Lethality Calculation
Lethality calculation is typically used for most types of sterilization and Depyrogenation ovens
etc. It calculates the number of equivalent minutes spent at the Base Temperature for each
sensor.
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To specify the Lethality calculation, enter the following parameters:
• Base Temperature
• Z value
• D value if enabled in preferences (default one minute)
• Calculate Lethality (dropdown includes “During Entire Cycle” and “During Exposure
Cycle”).
Note: Defining of an Exposure Cycle is only required if lethality is defined “During Exposure”.
Saturation Temp / Pressure of Steam
Figure 103: Saturation P/T of Steam
The Saturation Pressure of Steam is calculated based on a selected temperature sensor. It
calculates what the ideal temperature should be for a saturated steam condition. The
calculation is then compared to an actual pressure sensor.
The Saturation Temperature of Steam is calculated based on a selected live Pressure Logger.
It calculates what the ideal pressure should be to for a saturated steam condition. The
calculation is then compared to an actual temperature sensor.
Note: If a Temp / Pressure Logger is not specified in the Sensor Configuration screen, then
the Saturation Temperature of Steam cannot be defined.
When all calculation definitions are completed, select Qualification Parameters to enter the
Qualification parameters screen.
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Options
Qual Start
Qual Stop
1
Manual
Manual
2
Manual
Cycle Time
4
Time of Day
Cycle Time
8.7. Specifying Qualification Parameters
Figure 104: Qualification Parameters
Specify the conditions that control the qualification study on the Qualification Parameters
screen. From this screen, 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. There are three options, Sampling Rate, RF Transmission
Rate, and RF Threshold.
Start / Stop Conditions
Loggers may be programmed to start data collection Manually when the Qualification is
started or based on the Date / Time of Day. Loggers may be programmed to stop collection
Manually or based on Cycle time. If the Users selects start Qual on time, they can enter a date
and time up to three days from the current time. When the Setup is saved, the software
prompts the User if they would like to edit the time before starting the Qual. If yes is selected,
then the User can edit the time just prior to programming the Loggers.
Qualification Start / Stop Conditions and Related Delays:
3 Time of Day Manual
• Time of Day cannot be programmed for more than 72 hours after Loggers are
programmed. After 72 hours, the Loggers are set to shelf mode if a study is not started.
Note: When programming the start on time of the day, program one sample before the
required first sample timestamp. E.g., If the first sample is required at 14:30:00 and the
sample rate is 30 seconds, program the study start for 14:29:30.
• Cycle Time does not have any duration limit, cycle time duration is dependent on
sampling rate and the number of samples. The maximum number of collected samples
is 100,000 per sensor.
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Data Storage / Transmission
The Sample Rate is how often the Loggers store the data to their internal memory. The
memory capacity of each sensor is 100,000 samples. When the Loggers reach 100,000
samples the Loggers automatically stop collecting any new data. The sample rate dropdown
has several choices ranging from every one second to ten minutes.
The Transmission rate is how often the Logger transmits samples to a Base Station. It also
dictates how often the live and historical data updates on the Console. Transmission rate
impacts battery life.
Note: When a User manually stops a study the Base Station waits until the next transmission
rate to notify the Loggers, therefore if a ten-minute transmission rate is selected, it
could take up to ten minutes after Qual Stop is pressed for the Loggers to stop
collecting data. When Qualification Parameters definitions are complete, select Review
to check the entries and save the Setup.
RF Transmit Threshold
Battery Life is considerably affected by cold temperatures, if you are operating at cold
temperatures and do not necessarily need to see live data, then set the RF Transmit
Threshold to automatically turn-off RF transmission when inactive temperature is reached. The
internal data storage rate to the Logger is not affected and continues uninterrupted, only the
transmission of data is affected. When a Logger’s body temperature, note, not the sensors
temperature, climb above the Active temperature the RF transmission is activated, and the
Loggers begin to retransmit all old and current data to the Base Station and Console.
8.8. Reviewing and Saving a Setup
Figure 105: Setup Review Screen
After pressing Review, the Review screen opens, listing all the pertinent details about the
setup that was created.
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This screen also displays the following sections, each with an Edit icon to permit rapid
changes:
• Asset Details
• Sensor Details
• Calculation
• Groups
• Report Header
• Qualification Parameters
Select Save to save the setup or use Back to exit the Setup menu without changes.
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 a .pdf file for saving and printing.
8.9. Modify an Existing Setup
Setup files for a specific asset are listed on the Setup screen. To modify an existing setup file:
From the Setup Hub screen, select the setup file to modify.
Select the Edit (pencil) button.
Note: User permissions must be given to modify a setup.
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Chapter 9. Qualification Study
9.1. Overview
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 selected setup to
perform the qualification study. Depending on the start and stop qualification conditions
defined, the study performs a fully automatic qualification, a fully manual qualification, or a
mixture of automatic and manual.
The ValProbe RT Loggers utilizes internal memory to maintain qualification data during a
study. During the study, data from the Loggers is stored in internal memory based on the
defined Sample Rate and transmitted via the transit rate to the Base Station for storage. The
Base Station also transmits the data to the Console for display and viewing. When
Qualification is complete, the Base Station searches for any missing samples and connects to
the affected Loggers to collects missing samples. The User can then save the file and the
study file is transferred to the Console. Qualification data resides in the internal memory of the
Base Station until it is transferred to the console.
The Base Station is also equipped with a Lithium battery to provide short-term power, 60
minutes, in case of AC power loss during the run. The intent of the battery is to provide
enough time (approximately 60 minutes) to perform an orderly shutdown of the system. When
the Kaye ValProbe RT detects that the AC power has failed and the system is running from
battery, it displays an indication on the front panel LED.
When the qualification study is complete, and the Study file has been transferred to the
software it is automatically stored to the Asset under Qualifications. From there reports are
generated via the software to document the specifics and results of the study (See Chapter
12).
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9.2. Initiating a Qualification Study
Before the initiation of the qualification process, ensure the following.
• Base Station is located as close as possible to Asset being validated to maximize signal
strength (Max distance from Base Station to all Loggers 450 ft (~150 meters) line of
sight).
• Base Station is connected to Console / Docking Station via Direct Ethernet connection
via Static IP or to Network via Ethernet DHCP. (See Chapter 3). After physical
connections are made and then Power Up the Console and then the Base Station.
• Ensure all Loggers to be utilized for the study are available, and near the Base Station.
Note: Kaye recommends that the User first connect, program, and Start the Qualification
before placing the Loggers in the Asset. This ensure all Loggers are properly started.
The additional data collected prior to starting the process can be disregarded when
marking cycles.
Select a Setup File
The Qualification Study is based on the parameters defined in the Setup file. Prior to the
Qualification the Setup file that will be used needs to be selected. To select and load the
Setup file perform the following steps:
• From the Main menu select Assets
• From the Setup tile select the desire Setup to be run and select Initiate Qualification
The pop window gives the opportunity to change the SOP Protocol Number and display the
run number. The run number counts automatically, but it is editable if required. Pressing OK
opens the Select Base Station screen.
Figure 106: Selecting Setup File
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Connecting to Base Station
From the Select Base Station screen select Discover to search for all available connected
Base Stations.
Note: If connected via Static IP only one Base Station should appear. If connected via
Network DHCP all Base Stations which can be seen on the Network will appear. Only
one Base Station can be connected during the Qualification study.
Figure 107: Select Base Station
Select the Base Station to be used for the Qualification study and select Connect. The
software will connect to the Base Station, load the selected Setup, and move to the move to
the Select Loggers screen
Note: If the Base Station fails to connect, select the Base Station, and select Configure and
then select Set Base Station to Idle. This resets Base Station and Loggers to Idle
mode. Select Connect to connect to the Base Station.
Each Base Station firmware version is compatible with a specific Logger firmware
version. The software checks for Base Station and Logger firmware compatibility and
warns or blocks user action if they are incompatible with a message window.
Selecting and Connecting to Loggers
If the Loggers are not running a Verification or Qualification they are placed in Idle mode and
then, after 15 min of no communications, in Sleep mode to preserve battery. To connect to the
Loggers, they need to be awakened. The Loggers internally contain a magnetic switch which
is only used to awaken the Loggers.
Note: To wake Loggers, swipe the supplied Wakeup Device over the base of each Logger, or
swipe the base of each Logger over the Kaye Logo on the Base Station LED panel.
Figure 108 Wakeup Device & Base Station
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As each Logger is awakened, a long beep is audible from the Base Station and the Logger tile
appears with the serial #, Logger type, battery indication, mode, and a green dot specifying the
number of sensors in the Logger. The bottom right of the screen displays the number of
sensors that are configured in the Setup for the study.
Note: If any Loggers fail to awake and cannot be detected, place the Logger on the Wakeup
device for 30 second. The Logger initiates a reset and moves to Idle mode and try to
awake the Logger again. If the Logger still does not awaken the battery may need to be
changed.
Once all Logger have been awakened, select which Loggers to use in the study by selecting
them individually or by pressing Select All Loggers.
Note: When using more than 25 Loggers, ensure that the transmission rate is equal or
greater than the sampling rate. If not, a message displays a warning that you cannot
move forward. Modify the setup and the transmission/sampling rates before proceeding
with 25 or more Loggers.
Figure 109: Select Loggers
Select the Logger Details button to display detailed information about each Logger.
Information includes Type, Serial #, Battery %, Battery Reset Date, RF Link, Study Stop
Reason, FW Version, the last manufacturing Cal date, and the last User Verification date.
Select Live Loggers to return to the previous screen.
Note: The Loggers Detail screen provides an easy way to check that each Logger has the
appropriate amount of battery life for the upcoming Qualification study. If a Logger
needs to be replaced prior to the study, see Chapter 2 to manually replace the battery.
From the Select Loggers screen select the involved Logger and select Battery Reset to
reset battery odometer.
Select the Sorted button to sort Loggers by Serial#, Battery %, and Signal Strength. Select
the Filtered button to filter by Logger type to provide an easier analysis of selected Loggers.
The “Logger Awake For” and the dropdown below it, display the amount of time Loggers will
remain awake before starting the Qualification then go back to Sleep. The awake time
dropdown includes times up to an hour.
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Re-reading Loggers
Loggers maintain data from the previous study until they are programmed with a new Setup.
Loggers may be re-read prior to being programmed and cleared. Use the Re-Read button to
re-read Loggers. Select the Loggers that need re-reading and then select Re-Read. A window
opens, select the Study by checking the checkmark and then OK. Use the Save Study button
to save the study once any Loggers are re-read.
Note: A Merge checkbox is enabled if a study file already exists (StudyID). To merge, check
the Merge checkbox, then OK. The prompt below displays, to merge the studies, select
Create a new file using an existing file, to create a separate file select, Create a new
file independently.
Figure 110: Merging Prompt
Battery Estimate
Figure 111: Battery Estimate Screen
Select the Battery Estimate button to open the Logger Battery Estimation screen. Here you
can ensure that the selected Loggers have enough battery life for the length of the study. Fill
in the information under Study Details, dependent on the particular study and select Calculate
to begin displaying battery levels in the table on the right. If a Logger’s battery is sufficient for
the study, a green checkmark and “Proceed” displays in the far-right columns otherwise, a red
checkmark and “Warning” displays. Select the X in the top-right corner when ready to leave
the screen, if you have any Loggers that have a warning, the prompt below displays, either
select Yes to unselect the Loggers listed or select Continue Anyway to return to the Select
Loggers screen.
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Figure 112: Insufficient Battery Prompt
When all Loggers have been selected select Mapping Sensors.
Mapping Sensors
In the Setup, the number, type (Temp, Press), label, and description of each Logger is
defined, however the configuration is not tied to a specific Logger serial number or sensor.
Before starting a qualification, select Loggers and then map or link the specific Logger and
sensor to the Logger types defined in the Setup.
On the Mapping Sensors screen, the blue tile above the overlay diagram represents the
different groups assigned in the Setup. If defined in the Setup, each selected group displays a
layout diagram.
The sensors pane on the right displays sensors from the Loggers that have been previously
selected. To map the serial number of the Logger sensor to the configured sensors, drag the
serial number over the sensor label location. The Logger label is then tied to the serial number
of the Logger sensor. Continue until all sensors have been assigned or mapped. As each
sensor serial number is mapped, the color of the sensor serial number changes from white to
black. Above the group tile, “Unassigned Sensors” displays the number of sensors yet to be
assigned or mapped.
Figure 113: Mapping Loggers - Overlay
To move sensor layout positions, drag each label to the new position. If no Overlay picture
was created in the Setup, select the icon below the sensor pane and import a new picture or
use the camera to take a picture.
Use the Clear Map button to clear all group mapping and restart the process. Double select
any sensor to open a Clear button, select Clear to remove the mapping for the selected
sensor.
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Selecting the Print icon opens a selection box to create a .pdf file of the current displayed
group overlay or all group overlays. These .pdf files can later be downloaded into the
Documents section of the Asset screen for future reference.
For an alternate method to map sensors, select the icon to the right of the Printer icon to
assign sensors from a tabular format, define or edit sensor descriptions, by selecting the
description field. Select the same icon to return to the Overlay view.
Figure 114: Mapping Loggers - List
9.1. Auto Mapping Sensors
Additionally, the ValProbe RT System can automatically select Loggers and then map or link
the specific Loggers and sensors to the Logger types defined in the Setup. To do this, select
the Auto Mapping button and then check either Select All or each individual group of sensors
and select OK. A combination of both manual and auto mapping is possible.
Use the Clear Map button to clear all group mapping and restart the process. Double select
any sensor to open a Clear button
Figure 115: Auto Mapping Sensors
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Figure 116: Real Time Study Switch
9.1. Real Time Off Study
On the Mapping Sensors screen there is the option to turn Real Time Data off. Use this option
if you would like to run a study without the need to see data as it is recorded in real time. Move
the Real Time Study switch to Off by selecting the switch. When real time data is off, the
switch is red and begins to blink.
Select Program Loggers, a window opens prompting you with an acknowledgement that real
time data is off, select Yes to proceed.
Figure 117:Mapping Sensors - Real Time Data Off Prompt
The process is the same for real time Off and ON. Once all Loggers are programmed, select
Qualification to open the Qualification Screen. The upper right corner displays “Study Type:
Real Time Data Off” when real time data is shut off. However, the sensors display real time
data up until you select Start Qual.
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Figure 118: Real Time Off Qualification Screen
Start the Qualification by selecting Start Qual. A prompt displays to ensure that you are aware
that real time data is off, select Ok to start and return to the Main screen.
Figure 119: Start Qual - Real Time Data Off Prompt
The study continues to run and can be accessed by moving the sensors close to the Base
Station running the study and then using the software to connect to the Base Station. Once
connected to the Base Station select Show Real Time Off, any Real Time Off studies using
the connected Base Station display in the window below:
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