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Validation
Kaye Validator
®
AVS
User Manual
M5100-EN Rev. K
September 2020
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Kaye Validator ® AVS
Thermal Process Validation System
User Manual
M5100-EN Rev. K
September 2020
Copyright © 2020 Amphenol Thermometrics, Inc.
967 Windfall Road
St. Marys, PA 15857-3333, USA
Web: www.kayeinstruments.com
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Contents
Validator AVS User Manual i
Chapter 1. Kaye Validator AVS ................................................................... 1
1.1. Introduction ................................................................................................... 1
1.2. Validator AVS Benefits .................................................................................. 2
1.2.1. Validator AVS Hardware ......................................................................... 2
1.2.2. Validator AVS Console / Software .......................................................... 2
1.3. About this Manual .......................................................................................... 3
1.4. The Validator AVS System ............................................................................ 4
1.4.1. Validator AVS Hardware ......................................................................... 4
1.5. The Validator AVS Console / Software ................................ .......................... 5
1.5.1. Study Setup ............................................................................................ 6
1.5.2. Sensor Calibration .................................................................................. 7
1.5.3. Qualification Study ................................................................................. 8
1.5.4. Report Generation .................................................................................. 8
Chapter 2. The Validator AVS Hardware .................................................... 9
2.1. Introduction ................................................................................................... 9
2.1.1. Connection Ports .................................................................................. 10
2.1.2. LED Panel ............................................................................................ 12
2.1.3. Side Port for Data Transfer ................................................................... 13
2.1.4. AVS Docking Mechanism ..................................................................... 14
2.1.5. Internal Memory ................................................................................... 15
2.1.6. Backup Battery ..................................................................................... 15
2.1.7. Sensor Input Modules (SIMs) ............................................................... 17
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Validator AVS User Manual ii
2.1.8. Wiring SIMs .......................................................................................... 18
2.2. Kaye IRTD ................................................................................................... 25
2.3. Temperature Reference .............................................................................. 26
2.3.1. Sensor and IRTD Installation ................................................................ 28
2.4. Connecting the AVS Console to the AVS Hardware .................................... 30
2.5. Preventive Maintenance .............................................................................. 37
2.5.1. Fuse Replacement ............................................................................... 37
2.5.2. Calibration ............................................................................................ 37
2.6. Transporting and Shipping........................................................................... 38
Chapter 3. Initial AVS Console/Software Setup ....................................... 39
3.1. Introduction ................................................................................................. 39
3.2. Logging in as a Default System Administrator ............................................. 40
3.2.1. Creating New System Administrator Accounts...................................... 43
3.3. Creating New User Accounts ....................................................................... 45
3.3.1. Deleting and Disabling User Accounts .................................................. 46
3.3.2. One Time Emergency Access .............................................................. 47
3.4. Setting Preferences ..................................................................................... 48
3.5. Setting Policies ............................................................................................ 50
3.6. Updating the Validator AVS Firmware ......................................................... 52
3.7. Handling Data Files ..................................................................................... 53
3.8. Online Help ................................................................................................. 58
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Validator AVS User Manual iii
Chapter 4. Equipment ................................................................................ 59
4.1. Adding New Equipment ................................ ............................................... 60
4.2. Checking Details / Studies for Existing Equipment ...................................... 61
4.3. Equipment - Calibration Reminder ............................................................... 62
Chapter 5. Defining Assets ....................................................................... 63
5.1. New Asset Screen ....................................................................................... 64
5.1. Asset Details Screen ................................................................................... 66
Chapter 6. Defining Study Setups ............................................................ 69
6.1. Create a Setup File ..................................................................................... 70
6.2. Modify an Existing Setup ............................................................................. 70
6.3. Define Setup Screen ................................................................................... 71
6.4. Sensors Configuration Screen ..................................................................... 72
6.5. Understanding Groups ................................................................................ 75
6.6. Assigning Sensors to Groups ...................................................................... 76
6.7. Specifying Calculations ............................................................................... 78
6.8. Specifying Calibration Parameters ............................................................... 79
6.9. Specifying Qualification Study Conditions .................................................... 81
6.10. Reviewing and Changing the Setup ......................................................... 82
Chapter 7. Calibrating and Verifying Sensors ......................................... 83
7.1. Introduction ................................................................................................. 83
7.2. Loading a Setup into the Validator AVS ....................................................... 85
7.3. Selecting Sensors ....................................................................................... 86
7.4. Calibrating or Verifying Sensors ................................................................... 87
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7.4.1. Automatic, Semi-Automatic or Manual Mode ........................................ 88
7.4.2. Calculate Stability ................................................................................. 88
7.4.3. Calculate Deviation of Uncalibrated Sensors ........................................ 89
7.4.4. Calculate Deviation of Calibrated Sensors ............................................ 89
7.4.5. Data Logging Complete at Setpoint....................................................... 89
7.4.6. Graph View ........................................................................................... 90
7.5. Current Calibration and Hardware Connections ........................................... 90
7.5.1. Calibration / Verification Study File ....................................................... 91
Chapter 8. Qualification Study .................................................................. 92
8.1. Introduction ................................................................................................. 92
8.2. Loading a Qualification Setup ...................................................................... 93
8.3. Qualification Start / Stop Conditions ............................................................... 95
8.4. Qualification Real-Time Displays ................................................................. 96
Chapter 9. Monitor Mode .......................................................................... 102
9.1. Select Validator AVS ................................................................................. 102
9.2. Monitoring Live Data .................................................................................. 104
9.3. Check Communications Connections ......................................................... 106
9.4. Sensor Offsets ........................................................................................... 107
9.5. Access Study Files .................................................................................... 108
Chapter 10. AVS Reports ........................................................................... 109
10.1. Setup Report .......................................................................................... 110
10.1.1. Generating the Setup Report .......................................................... 111
10.2. Sensor Calibration Report ................................................................ ...... 111
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10.2.1. Generating Sensor Calibration Report ............................................ 112
10.3. Sensor Verification Report ..................................................................... 112
10.3.1. Generating Sensor Verification Report ............................................ 113
10.4. Qualification Reports .............................................................................. 113
10.4.1.
Qualification Detailed Re
port .............................................................. 114
10.4.2.
Qualification Summary Report
........................................................... 115
10.4.3.
Qualification Interval Calculations Report
.......................................... 116
10.4.4. Graph Reports .................................................................................... 117
10.4.5. Pass / Fail Criteria Report ............................................................... 127
10.4.6.
Qualification CEI 60068 Report
......................................................... 138
10.4.7. CSV-Export Report ......................................................................... 138
10.5.
Generating Qualification Reports ........................................................... 139
10.5.1. Selecting a Qualification File ........................................................... 139
10.5.2. Mark Cycles Screen ........................................................................ 140
10.5.3. Edit Groups and Calculations .......................................................... 144
10.6. Select Report Type and Options ............................................................ 147
10.7. Audit Trial .............................................................................................. 152
Appendix A. AVS Calculations Lethality, Saturation, and MKT Calculations 155
Appendix B. Understanding Audit Trail Events ........................................ 161
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Appendix C. Environmental Compliance ................................................... 166
C.2 Battery Disposal ........................................................................................ 167
C.2.1 What do the Markings Mean? ............................................................. 167
C.2.2 The Risks and Your Role in Reducing Them ...................................... 168
C.2.3. System Specifications ......................................................................... 169
C.3 FCC Part 15 Details................................................................................... 170
Appendix D. Safety and Precautions ......................................................... 171
Appendix E. Service Information ............................................................... 172
Appendix F. Warranty and Disclaimer: ..................................................... 172
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Chapter 1. The Kaye Validator AVS
Kaye Validator AVS User Manual 1
Chapter 1. Kaye Validator AVS
1.1. Introduction
Figure 1: Kaye Validator AVS
The Kaye Validator® AVS system is a validation system designed for thermal
process validation in the pharmaceutical and biotechnology industries. It features
automated and manual sensor calibration / verification, qualification studies and
reporting.
A complete Kaye validation package includes:
A Kaye Validator AVS.
A Kaye Validation Console for programming and control.
Up to four Kaye Sensor Input Modules (SIMs) per Validator.
A Kaye Temperature Reference; (Low Temperature LTR-90, LTR-
40/140, LTR150, CTR-40, CTR-80) or (High Temperature HTR400,
HTR 420).
A Kaye IRTD Traceable Intelligent Temperature Standard.
Premium grade thermocouples. Additional temperature and non-
temperature sensors for qualification studies (optional).
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1.2. Validator AVS Benefits
A Kaye Validator AVS system consists of the Validator AVS and the Validation
Console. The console can be docked directly to the Validator AVS and used as the
operator interface to the Validator AVS. Selectable input capacity (1 to 4 SIMs) up to
48 total inputs.
1.2.1. Validator AVS Hardware
Standalone operation for running Qualification, and Calibration/
Verification studies
Expanded Sensor Capacity: 48 inputs T/C, RTD, Volts, and Current
inputs
Improved SIM design and sensor connectivity
Improved scan time 36 channels / sec (DAQ 1), 48 channels / sec
(DAQ 2)
Ethernet/ Wi-Fi/ Docking Station connectivity with AVS Console
Battery Backup with field replaceable battery pack (three hours)
Internal memory for data storage of last ten studies
Improved connectivity with Kaye IRTD and Kaye Temperature
References
Backward compatible with Kaye IRTD, Kaye Dry Wells, and Baths
IP55 rated, chemical resistant ABS housing with carry handles
1.2.2. Validator AVS Console / Software
Hardened, rugged Console (Windows 10 LTSC) dedicated to
validation tasks pre-loaded with all Kaye AVS software
Easy-to-operate / state-of-the art intuitive user interface
Ethernet/ Wi-Fi/ Docking Station connections to AVS hardware
Asset centric concept for process equipment and Kaye hardware
Improved Reporting Tool –including Pass / Fail Report
Core Load and Software designed to address Data Integrity and 21
CFR Part 11 requirements
Sync functionality for data back and storage
Reduces Validation effort and provides enhanced reliability
Console includes hot swappable battery and onboard camera
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Kaye Validator AVS User Manual 3
1.3. About this Manual
The first section of this manual provides an overview of the Validator AVS hardware,
instructions for creating user accounts, entering asset and equipment information,
and an overview on using the Validator AVS software. The second section of this
manual covers, using the Validator AVS, including calibrating sensors, running
qualification studies, and verifying sensor calibrations.
The following is a brief description of each Chapter of this user's guide:
Chapter 1 provides an overview of the Validator AVS system.
Chapter 2 explains the Validator AVS hardware and provides
instructions to connect the system.
Chapter 3 provides instructions for creating user accounts and
privileges.
Chapter 4 provides instructions for entering Kaye equipment into the
system.
Chapter 5 provides instructions for entering assets into the system.
Chapter 6 provides instructions for creating setups.
Chapter 7 provides instructions for performing calibration or
verification.
Chapter 8 provides instructions for performing a qualification study.
Chapter 9 provides instructions for displaying live data on the Console.
Chapter 10 provides instructions for creating reports.
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Chapter 1. The Kaye Validator AVS
Kaye Validator AVS User Manual 4
1.4. The Validator AVS System
The Validator AVS system integrates hardware and software and provides
unparalleled accuracy and flexibility to configure studies, calibrate and verify
sensors, run qualification studies, and generate reports to evaluate the performance
of your processes.
The Validator AVS system has two main components the Validator AVS hardware
and the Validator AVS Console.
1.4.1. Validator AVS Hardware
The Validator AVS is the heart of the Validator AVS system and it can run as a
standalone unit.
All connectivity to sensors, calibration equipment, as well as the AVS console is
done through the AVS. The AVS performs all sensor measurement, calculations,
and generation of raw encrypted data files. Once a configuration / setup is
downloaded from the console, the AVS hardware controls the complete Qualification
as well as Calibration / Verification process. The AVS then creates and stores
encrypted data files to its internal storage and sends those files to the Console for
reporting and analysis.
Figure 2: Validator AVS Hardware
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Kaye Validator AVS User Manual 5
1.5. The Validator AVS Console / Software
Figure 3: Validator AVS Console
The Validator AVS system includes a portable, hardened dedicated validation
Console running on Windows 10 LTSC. There are two different designs of the
console, but each have the same functionality. The AVS Console is pre-loaded with
a customized Kaye core-load designed to meet data integrity requirements and limit
applications to only those necessary for validation needs.
The AVS Console can be docked directly into the AVS hardware or connected via a
WIFI or LAN connection. The AVS Console / Software provides an interface for the
AVS to configure and control the AVS hardware during validation processes. It also
provides real-time display, data storage, and a powerful reporting tool for post
analysis of Qualification data.
AVS software contains features to do the following:
Create Assets
Create Setups
Perform Sensor Calibration
Run Qualification Studies
Perform Sensor Verification
Create Qualification Reports
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Kaye Validator AVS User Manual 6
1.5.1. Study Setup
The study setup defines everything required to calibrate sensors and run a
qualification study. When you create a setup, you:
Define the number and type of sensors to be used in a Qualification
Study
Assign sensors to groups (Distribution / Penetration) for reporting and
calculations purposes
Define group events to be monitored during the qualification study
Specify calibration setpoints, temperature stability, and deviation
criteria for sensor calibration and verification
Specify start and stop conditions for the qualification cycle and the
exposure cycle
Specify data storage rate. All calculations are based on storage rate
Define the output relays
After you have created and saved your setup, you run the study by loading the setup
via connection from your Console to the Validator AVS. See also the Validator AVS
online help for instructions on setting up a study.
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1.5.2. Sensor Calibration
The Validator AVS provides both pre-qualification sensor calibration and postqualification calibration verification.
Before you perform a qualification study, you should calibrate the temperature
sensors to correct raw temperature readings to a traceable temperature standard.
You can perform a two-point calibration, or a two-point calibration with an additional
checkpoint. Sensors which pass the calibration process will have their offsets loaded
into the SIM memory and can be utilized during the Qualification study. Sensors that
do not meet the pre-qualification calibration test criteria are marked as failed and are
not calibrated. Sensors that fail calibration are marked red in the live data screens
and cannot be used in a qualification study.
After the qualification study, you can perform a post-qualification verification to verify
that the sensor readings are still within the required criteria. You can perform a onepoint, two-point or three-point post-qualification verification or even change the
criteria before running the verification. If a sensor fails post-qualification verification,
the sensor is noted as failed, but the readings are still reported. Calibration offsets
are not changed during post-qualification verification.
If your validation system includes a Kaye temperature reference and a Kaye IRTD,
you can perform fully automatic pre-qualification and post-qualification calibrations. If
you do not have a Kaye temperature reference you can manually set the reference.
For sensor calibration instructions, see Chapter 7. Calibrating and Verifying
Sensors.
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Kaye Validator AVS User Manual 8
1.5.3. Qualification Study
During a qualification study, the Validator AVS performs calculations and compiles
data for your reports. For details on how to run the qualification study using the
Validator AVS software, see Chapter 9, Qualification Study and the Validator AVS
online Help.
1.5.4. Report Generation
The Validator AVS software includes a comprehensive reporting utility that allows
you to access original study data to generate easy-to-read reports to document the
specifics of your validation study. All reports are generated from secure data files
that can only be read by the Validator AVS software. You can create four different
report types:
Setup Report
Calibration Report
Qualification Report
o Detailed Report
o Summary Report
o Interval Report
o Pass / Fail Criteria Report
o CSV Export
Calibration Verification Report
Audit Trail Report
Once reports have been created, they are automatically generated as .pdf files and
stored with the appropriate Asset under "Reports".
For a more complete description of report generation, see the Validator AVS online
help.
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Kaye Validator AVS User Manual 9
Chapter 2. The Validator AVS Hardware
2.1. Introduction
The Validator AVS comes equipped with a universal power supply, a power cord for
115 VAC or 230 VAC, 32 GB of internal storage memory, and an USB flash drive
interface. This chapter describes the Validator hardware and provides instructions for
connecting the system. Included are sections describing:
The back of the Validator AVS hardware has connection ports for all
system devices and an emergency backup USB flash drive interface on
the left side.
AVS docking mechanism
AVS LED Panel
Internal memory
Backup battery
Sensor Input Modules (SIMs), used to connect sensors to the Validator
AVS
The Kaye temperature reference, which provides the stable temperature
required for sensor calibration
The Kaye IRTD, a self-contained temperature standard
Connecting the AVS hardware to the AVS Console
Preventive maintenance
Transporting and shipping
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2.1.1. Connection Ports
The Validator AVS has connectors on the back of the unit for easy plug-in of SIMs,
temperature standards, and temperature references. It also provides connection ports
for USB and Ethernet for the Console and the AVS Validator. Another separate USB
port is utilized for the yearly device calibration USB with ICAL software. The USB
memory card port on the left side of the instrument can be used to move raw encrypted
saved studies from the AVS directly to a thumb drive. An icon indicating the type of
device identifies each connector.
Figure 4: Validator AVS Connections
SIM Slots
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Kaye Validator AVS User Manual 11
2.2.1 Connection Ports (cont.)
Table 1: Connection Port Explanation
Icon
Connection Port
4 Pin Din Connector
There are three 4-pin DIN connectors, two for the IRTD and one
for the Temperature Reference.
(Note: The Validator AVS can accept data from only one IRTD at
any given time. For calibrations, only the upper port is active!)
Output Relay Ports
There are two NO/NC relay outputs, labeled with a contact switch
icon, to provide a dry contact to an external device. The contact
can be programmed in the Setup as to what action trigger the
contact.
Relay port 1 is second from the icon at the housing’s edge
Relay port 2 is near the icon.
Relay Rating:
110 VAC ½ amp resistive load
24 VDC 2 amp resistive load
USB Connector
One USB connector, labeled with a USB icon, is available to
connect an ICAL device. The ICAL port is for service use only.
USB/ Ethernet Connector
The AVS and Console icon offer both USB and Ethernet
connections.
The AVS USB can be used as extension of the Console for USB
data transfer or USB hub for keyboard etc. The Ethernet can
connect the Console to the network.
The AVS Ethernet, can set up a connection to the network.
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2.1.2. LED Panel
When the AVS is running in Standalone mode without the AVS Console connected, the
AVS LED panel can provide key status indications for the user. The front panel of the
Validator AVS displays the machine status with four LEDs. These LEDs display red,
green, or both colors, steady or blinking.
Figure 5: Validator AVS Front Panel
The LEDs indicate whether a console is connected to the Validator, if a study is
running and the status of the battery, and AC power status. Details are described
within Figure 6 below:
Figure 6: Validator AVS LED Status Messages
COMMUNI
CATION
LED
STATUS
LED
BATTERY
CHARGE
LED
POWER
LED
System boot up - Ini tial
System booting up
All LEDs are lit RED/Green once
System shutting down
System error
Depends on machine state
Study in progress
Consol e connected to Val ida tor AVS OFF
Battery capaci ty > 75%
Battery capaci ty < 75% Steady
Faul ty/Not-respondi ng Battery
Low Battery < 25%
Charging i n progress
Charging complete
Faul ty/Not-respondi ng Battery Bli nking
Battery not detected
OFF
LEDs
PWR
Switch
POWER
CONDITION
ON
AC or
BATT
BATT
AC
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Chapter 2. The Validator AVS Hardware
Kaye Validator AVS User Manual 13
2.1.3. Side Port for Data Transfer
On its left side, the Validator AVS offers a side port with a USB port (to accommodate
an emergency backup USB flash drive) and a data transfer button, as displayed in
Figure 7 below.
The Validator AVS writes the study data into the internal memory. If there is an unread
study available on the Validator AVS there is a message when connecting the console
and the study data is transferred to the console directly. Alternatively, the study data
can be dumped to the USB side port. After connecting an USB flash drive and pressing
the button, the last ten studies are written to the flash drive. The files can then be
reimported into the console through the AVS software. To provide data security, data is
stored in encrypted secure data files that can only be read by the Validator AVS
software. Files that have been tampered with are no longer readable by the software.
This port is only used for emergency backup, not for normal use during the
Qualification studies.
The AVS software also has a software utility in the Hardware section of Live monitoring
which allows you to view the last 10 studies stored in the AVS. From this screen you
can also transfer the files to the console. Use the AVS convert function (see 3.7
Handling Data Files) to import the files into the Validation console.
Figure 7: Data Transfers Side Port
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2.1.4. AVS Docking Mechanism
The AVS hardware also contains a patented docking mechanism to connect the AVS
Console to the AVS hardware.
Figure 8 below displays the procedure for docking the AVS Console to a Validator AVS
via its docking station.
Figure 8: Docking and Releasing Console
Note: The AVS Console can be docked to the AVS hardware with or without power
applied to the AVS hardware or AVS Console. The AVS Console can be
undocked from the AVS hardware with power off.
If Power is applied to Console and to AVS hardware, ensure that you first
navigate to Main screen in the AVS software and press "Disconnect" (upper
right side of the screen). Failure to do so could cause connection problems for
the next connection.
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Kaye Validator AVS User Manual 15
2.1.5. Internal Memory
The AVS hardware contains 4 GB of internal solid-state memory for storage of
Qualification and Calibration / Verification raw data files. At the completion of a study,
data files are automatically stored to the internal memory as well as transferred to the
AVS Console.
The internal memory always contains the last ten studies as a backup. These files can
be downloaded to a USB via the AVS side port or transferred via the AVS software from
the Live screen using the Hardware button.
2.1.6. Backup Battery
The Validator AVS is equipped with a rechargeable lithium ion backup battery to
provide short-term power in case of AC power loss. The intent of the battery is to
provide sufficient time (approximately three hours) to complete your study or address
the power failure. When the Validator AVS detects that the AC power has failed and
the system is running from battery, the power icon on the front panel changes from
green to red while the battery LED show the current battery state. Valid battery states
are:
Solid green = more than 75%
Solid yellow = less than 75%
Blinking red = less than 25%. Battery capacity is near depletion and
device shut down within the next 15 minutes.
Solid red = a battery defect
Blinking green = AC Power connected, and battery is charging
If AVS switches to battery backup or back to AC power during the study event,
messages appear on the live screen and are posted in the Audit Trail.
CAUTION! Power is still supplied to the unit via the backup battery after
the AC power cord is unplugged. Remove battery from the
battery pack before servicing the instrument. Use the Power
Switch located at the rear of the unit, do not cut the AC power
only.
When servicing the unit, first ensure that the backup battery is removed. To access the
battery, remove the two screws from the battery compartment on the bottom of the
AVS hardware.
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Kaye Validator AVS User Manual 16
The Validator AVS monitors its own battery voltage. When
the battery has approximately six minutes of power
remaining, the Validator AVS stops collecting data and
closes its data files. The unit is equipped with rechargeable,
field replaceable, battery pack. A replacement battery pack
is available (Type RRC2040-2, Kaye Art. Nr. 200-163).
CAUTION! Batteries must be disposed of in
accordance with local, state and federal
regulations.
Figure 9: Battery
Replacement
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Chapter 2. The Validator AVS Hardware
Kaye Validator AVS User Manual 17
2.1.7. Sensor Input Modules (SIMs)
The Validator AVS accepts up to 48 inputs in any combination of thermocouple,
voltage, current inputs, or 24 RTD inputs. The AVS uses Sensor Input Modules to
provide secure connections for sensors to the Validator AVS, while also protecting the
electronics from draft, dust, humidity, electrical noise, and mechanical shock. SIMs are
designed to be wired once and used repeatedly. Once the SIMs are wired, you can
calibrate multiple harnesses at the same time and store them for later use.
Figure 10: Sensor Input Module
The Validator AVS can accommodate up to four SIMs. Each SIM has:
Sensor inputs: TC-SIMs have 12 sensor input connections, RTD SIMs
can connect six RTD sensors, 4-20mA SIMs can connect 12 sensors,
and one connection for using an external power supply if needed or local
power. Refer to Z2612 for reference.
A memory chip to store calibration offsets, SIM serial number, slot
location, and the serial number of the Validator AVS measurement board
where calibration was performed.
A cold junction reference RTD to maintain measurement accuracy in
different environmental conditions.
Since calibration of thermocouples requires compensation for errors measured in
fractions of microvolts, making these offsets specific to this instrument and SIM
location, it is recommended that you use the supplied erasable labels to record:
SIM serial number
SIM slot number
Serial number of the Validator AVS where the sensors were calibrated
and the date they were calibrated
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Chapter 2. The Validator AVS Hardware
Kaye Validator AVS User Manual 18
When you want to use these SIMs, just pull them off the shelf and plug them in. The
calibration offsets are stored in the SIM's internal memory. To prevent you from using
the wrong instrument or SIM slot, the system alerts you during the qualification run that
the SIM is plugged into the wrong instrument or SIM slot. The SIMs are made of high
impact materials that will withstand 5000 insertions and are designed with a tilt and a
drain hole to minimize the effects of condensation.
IMPORTANT: SIMs are recognized by the system when you power up the Validator
AVS. Ensure that all SIMs are connected prior to powering up the
Validator AVS, or you should power down, insert your SIMs, and power
up again. If a SIM is disconnected after power up, calibrated offsets or
SIM data might not be read correctly. To rectify this, power down,
reconnect the SIM, and power back up.
2.1.8. Wiring SIMs
There are two methods for wiring SIMs. You can assign sensor locations in your setup
file, and then wire the sensors according to the Setup Report, or you can buy pre-wired
SIMs or wire the SIMs yourself and then create a setup that reflects the sensor
locations. This section shows you how to wire SIMs yourself.
IMPORTANT: The SIM contains a static sensitive component that stores calibration
information. Use caution when connecting sensors. It is recommended
that you wear an anti-static ground strap when connecting sensors and
routing wires.
To connect sensors to SIM locations:
Loosen the two screws in the top of the module to open a SIM. Figure 11 below
displays the inside of a thermocouple SIM.
Figure 11: SIM Wiring
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Chapter 2. The Validator AVS Hardware
Kaye Validator AVS User Manual 19
Components:
Tie wrap mounts
Connector (locations 1 - 6)
Sensing RTD
Connector (locations 7 - 12)
Sensor location number. There are 12 connection locations, labeled 1 - 12, with a
positive and negative connector for each input.
Press the two press-keys to open connectors where the sensor is to be inserted.
Connect your inputs. Valid inputs are the following:
Thermocouples T, J, B, S, R, N and K
(see Connecting a Thermocouple in this chapter)
Contacts (see Connecting a Contact in this chapter)
Voltage (see Connecting a Voltage Input in this chapter)
Current (see Connecting a Current Transmitter in this chapter)
Release the two keys.
Repeat Steps 2 through 4 for all remaining sensors.
Once all sensors are connected, route the wire harness around the connectors and
out the drain hole. Secure the harness with the tie wraps provided. Follow Figure
12 below to maintain peak module thermal accuracy.
Figure 12: SIM Wiring
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Legend:
1 = Tie wraps (provided)
2 = Tie wraps (optional - user-supplied)
3 = Drain hole
Tighten the two screws at the top of the module to close the SIM.
Label the SIM with SIM slot number, SIM serial number, the Validator AVS serial
number, and the calibration date.
Note: To wire the dedicated 4-20 mA SIM, see document Z2612, “4 to 20 mA Sensor
Input Module”.
2.3.1a Connecting a Thermocouple
Connect thermocouples to the connectors as shown in Figure 13 below. Cut through
the outer insulation to separate the wires, and then strip back each wire approximately
½ inch to make the connection with the connector.
Figure 13: Thermocouple Connections
Always connect the positive (+) lead to the positive (+) connector and the negative (-)
lead to the negative (-) connector. In conformance with ANSI standards The negative
thermocouple lead is normally red.
Moist Heat Environments
When validating moist heat processes, a sealed PTFE tip thermocouple should be
used with a drip cut (shown in Figure 14 below) on the outer insulation close to the SIM
module to reduce the possibility of drawing moisture into the SIM.
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Note: The design of Kaye AUTOBOND wires eliminates any moisture seeping, making
a drip cut unnecessary. Contact customer care for more information regarding
Kaye AUTOBOND wire.
To add a drip cut, remove 4 inches (10 cm) of the outer insulation from each
thermocouple at a point where natural drainage can take place without water reaching
the terminal screws.
Figure 14: Drip Cut
Also, it is recommended to shave open approximately 1/4 inch from each of the inner
wire jackets at opposite ends of the outer insulation drip cut. This permits condensation
drainage from within the individual wires, as shown in Figure 15 below. If Autobond
thermocouples are used, this is not necessary.
Figure 15: Shaving from the Inner Wire
If moisture does collect in the SIM, remove the SIM from the instrument, open it, and
let it air dry before storage.
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2.3.1b Connecting a Contact
You can connect dry contact inputs directly to the TC-SIM, as shown in Figure 16
below. Dry contact inputs can be used to make a time notation in the data file (to mark
start exposure, stop exposure, start of qualification, end of qualification) and to mark
any events that occur during the qualification study. You can also wire a dry contact to
your vessel's PLC to detect status output and use it to automatically mark the start and
end of the exposure cycle during the qualification study.
Figure 16: Connecting Dry Contact Inputs
2.3.1c Connecting a Voltage Input
Connect a voltage input (up to 10 VDC) to the connectors, as shown in Figure 17
below. Always connect the positive (+) lead to the positive (+) connector and the
negative (-) lead to the negative (-) connector.
Figure 17: Voltage Input Connection
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2.3.1d Connecting a Current Transmitter
A dedicated 4-20 mA SIM is available that provides 12 current inputs and a connection
for an external power supply.
However, a current transmitter can also be connected to the standard TC-SIM.
Connect a precision shunt resistor to the connectors to convert the current to a
measurable voltage, as displayed in Figure 18 below. A 250 resistor converts a 4-20
mA signal to a Voltage signal. The 62.5 resistor converts a 4-20 mA signal to 0.25-
1.25 V. These voltages can be defined in the TC setup as voltages accordingly. For
easier handling, we recommend using the dedicated 4-20 mA SIMs in the first place.
Figure 18: Current Transmitter Connection
The 4-20 mA SIM can be configured in two ways based on the power connections. You
can switch between external or local power, based on the placement of the jumper
blocks as displayed in Figure 19 and Figure 20. Please refer to instructions on the SIM
for current jumper placement and orientation.
Sensors using 4-20 mA outputs can be attached in several different ways.
If the sensor requires less than 4 mA to operate:
Connect the positive lead to the positive input channel and the negative
lead to the negative input channel, as displayed in Figure 19 below.
Configure the jumper block for local power and attach 24V supply to J4.
Figure 19: Configuration for Sensor with < 4 mA Power
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If the sensor requires more than 4 mA, it normally has a second set of terminals to
supply power:
Connect the transmitter output to the input channel (+ to + and - to -), as
displayed in Figure 20.
Configure the jumper block for external power.
Figure 20: Configuration for Sensor with More than 4 mA Power
If a sensor requires less than 4 mA to operate and is loop powered remotely, see
options 1 or 2 below for connection. Configure jumper block for same channel as
External Power.
Figure 21: Configuration for Sensor with Less than 4 mA Power (Loop Powered
Remotely)
The red LED on the SIM is powered from the AVS and lights when the AVS is on and a
SIM is plugged in. The green LED is lit if the sensor is powered via the external power
source connector.
External Local
External Local
External Local
2
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2.2. Kaye IRTD
The Kaye IRTD temperature measurement standard is a traceable highly accurate
standard used by the AVS system to calibrate and or verify an AVS system accuracy
before a Qualification study. The measurement accuracy is traceable to the national
standard to 0.025ºC, with a range of -196ºC to 420ºC.
The IRTD provides a traceable standard that is used to correct the temperature
readings of your thermocouples. During the calibration process, the Validator AVS
automatically reads and monitors the value of the temperature reference and the IRTD
probe.
For Calibration or Verification, only one IRTD can be connected at a time to the AVS
hardware. Always connect the supplied IRTD cable to the upper IRTD icon DIN
connector.
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2.3. Temperature Reference
Temperature references provide the stable temperature required for sensor calibration.
Six temperature reference models are available. They are designed to provide different
temperature ranges and are compatible with the Validator AVS. Utilizing the supplied
AVS to Temp Reference cable, attach it to the Temperature Reference icon located on
the back of the AVS hardware.
LTR-90 (setpoint range -95°C to 140°C at 23°C ambient)
Recommended for calibration of sensors used in freeze dryers, freezers, cryogenic
units, incubators, and steam autoclaves. The LTR-90 accepts up to 12 thermocouples.
LTR -25/140 (setpoint range -25°C to 140°C at 25°C ambient)
Recommended for calibration of sensors used in freezers, cold rooms, incubators, and
steam autoclaves. The LTR -25/140 accepts up to 18 thermocouples.
LTR -40/140 (setpoint range -40°C to 140°C at 25°C ambient)
Recommended for calibration of sensors used in freezers, cold rooms, incubators, and
steam autoclaves. The LTR -40/140 accepts up to 18 thermocouples.
LTR-150 (setpoint range -30°C to 150°C at 25°C ambient)
The Kaye LTR-150 is a multi-purpose calibrator specifically designed to calibrate 48
thermocouples at once and function as a Dry Block, Liquid Bath, or Surface calibrator.
HTR 400 (setpoint range 50°C above ambient to 400°C)
Recommended for calibration of sensors used in steam autoclaves, dry heat ovens
and tunnel sterilizers. The HTR 400 accepts up to 24 thermocouples.
HTR 420 (setpoint range 30°C above ambient to 420°C)
Recommended for calibration of sensors used in steam autoclaves, dry heat ovens,
and tunnel sterilizers. The HTR 420 accepts up to 48 thermocouples.
CTR -80 (setpoint range -80°C to 30°C)
Liquid bath recommended for calibration of sensors used in freeze dryers, freezers,
and cryogenic units. The CTR -80 accepts up to 36 thermocouples.
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CTR -40 (setpoint range -40°C to 150°C)
Liquid bath recommended for calibration of sensors used in freezers, cold rooms,
incubators, and steam autoclaves. The CTR -40 accepts up to 36 thermocouples.
CTR -25 (setpoint range -25°C to 140°C)
Liquid bath recommended for calibration of sensors used in freezers, cold rooms,
incubators, and steam autoclaves. The CTR -40 accepts up to 36 thermocouples.
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2.3.1. Sensor and IRTD Installation
The Kaye LTR-150, LTR-90, LTR -25/140, LTR -40/140, and the HTR 400 temperature
references have inserts for thermocouples and two Kaye IRTDs. Failure to use these
inserts to achieve proper thermocouple placement in the temperature reference results
in reduced accuracy during calibration.
The Kaye CTR -80 temperature reference has three thermocouple wells and two 12inch nylon spacers to allow you to properly position your thermocouples and Kaye
IRTDs.
LTR-150, LTR-90, LTR -25/140, LTR -40/140, HTR 400, and HTR 420
To insert thermocouple sensors into the LTR-150 LTR-90, LTR -25/140, LTR -40/140,
HTR 400, and HTR 420:
For the LTR-90, insert the thermocouple sensors through the rubber
insulator first.
IMPORTANT: The LTR-90 comes with a rubber insulator. This rubber insulator must
always be used. If it is not used, specifications are not guaranteed.
Also, at cold temperatures, there is significant ice buildup, which can
affect accuracy and uniformity.
Insert the thermocouple sensors into the inserts and push all the way down into the
well.
For 22-gauge wire, three Type T PTFE or Kapton thermocouples fit into each well.
For 28-gauge wire, six Type T PTFE thermocouples fit into each well.
To install the IRTD into the LTR-150 LTR-90, LTR -25/140, LTR -40/140, and HTR
400:
For the LTR-90, insert the IRTD through the rubber insulator first.
Slowly insert the IRTD into one of the two reference wells (the two small
wells) in the LTR-90, LTR -25/140, LTR -40/140, or HTR 400. Do not
drop it from the top of the well. To prevent mechanical shock to the IRTD
when immersing it in a new temperature environment, ensure that the
immersion process takes place over a 30-second interval. The IRTD
should fit snugly, but still be easily removed.
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CTR -80/-40/-25
To insert thermocouple sensors into the CTR -80:
Loosen the sliding clamp mechanism on a thermocouple well, insert the
thermocouple sensors 7.5 inches into the well, slide the clamp into place,
and tighten the clamp to hold the sensors in place. When properly
installed, the sensors will protrude approximately 0.5 inches beyond the
end of the thermocouple wells. For 22-gauge wire, 12 PTFE
thermocouples fit into each well.
Note: The 7.5 inches wide access cover can be used as a measuring device when
positioning the sensors.
To install the IRTD into the CTR -80:
Insert the IRTD into one of the two 12-inch nylon spacers. An IRTD with
the standard 18-inch stem fits properly. If you have an older model IRTD
with a 15-inch stem, shorten the length of the nylon spacers accordingly.
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2.4. Connecting the AVS Console to the AVS Hardware
The communication between the AVS Console and the AVS Hardware is based on
TCPIP protocol. The Validator AVS and the Kaye Validation Console typically connect
through the integrated docking station, but both components can utilize any kind of
TCPIP based network to interconnect using a wired Ethernet or a wireless Wi-Fi
connection.
To connect through TCPIP, an infrastructure (company network, router, or even
smartphone hotspot) providing a DHCP-server is required.
There are different ways to establish a connection between the console and hardware:
Docking port of the Validator AVS
Wired connection via Ethernet infrastructure (LAN)
Wireless connection via an access point (Guest WiFi, Mobile Hot Spot etc.)
Docking Port
Using the docking port is the simplest way to establish a connection between the
console and hardware. As illustrated in Figure 8 on page 13, insert the console into the
docking port of the AVS. The TCPIP based connection has the fixed IP address of
192.168.1.2 for the Validator AVS.
Note: The IP address 192.168.1.2 is fixed in the system and cannot be changed. To
avoid IP address conflicts please ensure this IP is not used in any connected
hardware (e.g. local networks).
For connection through the docking port simply select
USB/Docking and press Connect. The Console
begins connecting with the Validator AVS.
Connecting the AVS Hardware to Ethernet
Two Ethernet ports are located on the back of the Validator AVS. The icons alongside
the ports indicate the device the port is connecting to. Simply connect the Validator
AVS to a LAN network with an Ethernet cable. An IP address provided by a DHCP
server is required.
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Any console connected to the same network (either wired or connected via Wi-Fi) can
discover the AVS in the hardware screen and connect remotely. For
a wired connection, the Ethernet port for the console can be used
while docked. For office use, there is a separate docking station
available.
Connecting the AVS Console to Wi-Fi
Establishing a Wi-Fi connection of the console is very simple:
In the Startup screen, swipe from the right side or press the Pin button (see the arrows
in Figure 22 below) to open the Windows Action Center. Inside the Windows Action
Center choose Network. It is not necessary to log in as “Kaye Admin”.
Figure 22: Startup Screen with Windows Action Center and Network
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Inside Network a list of available network connections display. Ensure that the Wi-Fi
tile is blue and switched on, otherwise press the Wi-Fi tile. In the example below,
multiple networks are available:
Figure 23: Startup Screen and Network Connections
After choosing a network, connect by pressing Connect. If Connect
Automatically is checked, the console automatically connects to this
network if it is in range.
To establish a connection, a Wi-Fi password may be required. You
can get any required information from your Wi-Fi administrator. When
using the hotspot function for a mobile phone, the password is listed
in the configuration of the hotspot.
For first initial network connection, Windows prompts if you would like
to identify and connect to any other devices on the network. It is
recommended to choose Yes for unrestricted access inside the
network (please contact your IT administration for details).
Once connected to the network, the console is listed as connected to
the Wi-Fi.
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Connecting the AVS Hardware to Wi-Fi
The AVS hardware contains an onboard Wi-Fi card which must also be configured and
pointed to the same Wi-Fi network as the AVS Console.
After docking the console, choose Hardware/Discover on the
Homepage of the Kaye AVS software.
In the Select AVS window, choose the AVS you want to configure
for Wi-Fi. As mentioned, it is necessary to have an established
connection. It is recommended to dock the console with the AVS
and choose USB/Docking.
Figure 24: Select AVS Screen
After selecting the required AVS, press Configure Wi-Fi. A new dialog
box opens.
Enter the Network name (or SSID) of the network
manually or use the Network button to prepopulate the
available SSIDs automatically into a drop-down menu
for selection.
Note: The SSIDs in the drop-down are copied from the
console’s discovered Wi-Fi list. If you connect
remotely to the Validator AVS via Ethernet, these
networks may not be available in the remote
location.
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Set the security and encryption type for the network. If
you do not know these values use automatic and the
Wi-Fi card will try to ask these parameters from the
Wi-Fi network. If that information is not retrievable,
please ask your Wi-Fi administrator.
Note: Most modern Wi-Fi networks use WPA2-PSK and
AES as listed in the example. Use that option for
the best chance for a successful connection.
Enter the Wi-Fi password: In the example above the
password is generated by the mobile hotspot of the smartphone. Please ask your
Wi-Fi administrator if you do not know the password.
Note: The Validator AVS requires an encrypted Wi-Fi network. Open
networks without password are not supported.
Press Ok to transfer the new Wi-Fi setup to the Validator AVS.
After a short time, the message “Wi-Fi configured successfully”
displays.
Note: If an error message (Wi-Fi Configuration failed) appears, please ensure that the
Validator AVS and Wi-Fi network are available, and all information was entered
correctly.
If “Automatic” was selected to configure the network security and encryption, it
is possible the network did not provide the required information and it is
necessary to choose the correct values from the drop-down menus. The
Validator AVS is limited to 2.4GHz networks and the channels 1 to 11. 5Ghz
networks and channels 12 to 16 are not supported.
Press Discover, to ensure that the Wi-Fi IP address of the
Validator AVS is displayed.
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Connecting via Wi-Fi:
Select the AVS and press Connect. In the small popup choose Wi-Fi as the
connection type.
Figure 25: Select AVS Screen with Discovered AVS
It is now possible to undock the console from the AVS and still receive live data from
the Validator AVS via Wi-Fi.
Figure 26: Live Data Provided via Wi-Fi Connection
Note: In Validator AVS machines without Wi-Fi modules any attempt to configure Wi-
Fi results in the message “Wi-Fi configuration failed!”.
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If the discovered Validator AVS has valid IP
addresses for Ethernet and Wi-Fi, an option
appears when pressing Connect.
If only one IP address is available, the connection
is established to this address only.
Note: Occasionally, invalid IP addresses (starting
with 169.x.x.x) are displayed but not
functionable.
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2.5. Preventive Maintenance
2.5.1. Fuse Replacement
The Validator AVS is equipped with a 250V T 4A fuse. The fuse is in the line filter
along with the power cord. To replace the fuse:
Turn the power off.
Disconnect the power cord from the line filter.
Using a small, slotted screwdriver (provided with the SIMs), pry open the fuse
holder from the bottom tab.
Slide the fuse holder out and replace the fuse with a 250V T 4A replacement fuse.
2.5.2. Calibration
Each Validator AVS is fully calibrated before shipment. The equipment normally
requires no further adjustment or calibration during installation. Under normal operating
conditions, it is recommended you calibrate the Validator AVS once a year to maintain
peak system accuracy. If you use a Validator AVS for high accuracy measurements, or
circuit boards are replaced or added, you may need to recertify calibration.
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2.6. Transporting and Shipping
The Validator AVS is designed to be easily transportable from one place to another
within a plant. The unit weighs approximately 26.5 pounds (lbs.) or 12 kg, including the
Validation console (without SIMs) and comes with two robust handles for carrying.
For shipping the Validator AVS, you need a safe and durable container. A rugged,
foam-fitted hard case equipped with wheels and a collapsible handle is delivered
together with your Validator AVS. It includes secure space for the Validator AVS, the
Console, and accessories (SIMs, cables, etc.).
We encourage you to use this hard case for transport, storage, and shipping. If you
use another type of container, ensure that the Validator AVS is padded with four inches
of cushioning filler on all sides.
If you need to return the Validator AVS for service, contact the Customer Service
Department for a Return Materials Authorization Number before you ship. Include the
number with the instrument.
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Chapter 3. Initial AVS Console/Software Setup
3.1. Introduction
Before using the Validator AVS software to run Qualification studies, various initial
administrative settings need to be defined.
In this chapter the following Administrative functions are covered:
Start the AVS program and log in to the User Management utility using
the default System Administrator account.
Create your System Administrator account.
Set policies and preferences.
Create other user accounts.
Upgrade the AVS firmware.
Handling of files through file management
Access the Validator AVS online help.
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3.2. Logging in as a Default System Administrator
The Kaye validation console boots automatically into the Kaye Operator windows
account on startup. In the Startup menu, start the Validator AVS software by
double pressing the AVS icon.
Figure 27: Desktop Screen
Once you have started the Validator AVS software, the Login screen appears as
displayed below:
Figure 28: Login Screen
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Enter “Kaye” in the User ID textbox.
“Kaye” is the default System Administrator user ID. The User ID textbox is case
sensitive. Ensure that you enter the default user ID exactly as it appears here.
Enter “411” in the Password textbox, as the one-time default System Administrator
password.
Press Login.
After the initial Login, you start directly with the creation of a new system administrator
in the user management screen.
Figure 29: New User Screen - Create Initial System Administrator
Press New User and create a system administrator. The fields with red asterisks
are mandatory: User IDs are unique, and the password is following the default
rules for passwords (minimum of six characters).
Enter your new System Administrator identification into the User ID textbox. Your
user ID can be any combination of numbers and characters, up to a maximum of
16. A user ID cannot be used by more than one active account.
Enter your new System Administrator password in the Password textbox. Your
password can be any combination of numbers and characters, up to a maximum of
16. For security reasons, it is preferable to use more than six characters or
numbers.
Enter your password again in the Confirm Password Field and press OK.
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At this point, you should record your user ID and password for future reference. You
need both to log in to the Validator AVS. If you do not enter the correct user
ID/password combination, you will be denied access.
For the initial system administrator, the User Type and User privileges are preset. You
can enter a title, phone and email and even associate a picture by using the build in
camera.
After creating the new system administrator, by pressing Save the software
automatically logs out. From now on the initial Kaye/411 user is not available anymore.
The next time you log in to the Validator AVS Software, you will need to enter your own
System Administrator user ID and password. The system can identify you by name
using your unique user ID and password combination.
The Main screen appears (see below). You are now ready to create other admin and
user accounts and set the preferences and policies as required.
Figure 30: Main Screen
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3.2.1. Creating New System Administrator Accounts
Once you are logged in with the new system administrator account, you can add admin
and user accounts to the system and set site options.
Note: A good practice is to establish more than one individual with Administrative
functions. This way the Administrative functions can still be accessed even if
one of the System Administrators is unavailable.
To create a new System Administrator account:
Press the Admin tile on the Main screen. The Admin Settings window opens at the
Preferences tab.
From the Admin Settings window, press User Management.
On the User Management screen, press New User, and enter your name in the
Name textbox.
Figure 31: User Management Tab
The name you enter here displays later in the active user list on the left side of
the screen. In contrast to User IDs, usernames are not unique. Once you have
added your name to the active user list, you can enter the same name again.
Your name is associated with the user ID/password combination that you
entered. You use this user ID/password combination to log into the Validator
AVS.
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Enter your new System Administrator identification in the User ID textbox. Your
user ID can be any combination of numbers and characters, up to a maximum of
16. A user ID may not be used by more than one active account.
Enter your new System Administrator password in the Password textbox. Your
password can be any combination of numbers and characters, up to a maximum of
16. For security reasons, it is preferable to use more than six characters or
numbers.
Enter your password again in the Confirm password field and press OK.
At this point, you should record your user ID and password for future reference.
You need both to log in to the Validator AVS. If you do not enter the correct user
ID/password combination, you will be denied access.
Enter your designation and your contact names. Press Save to save your
information.
The User Management screen displays the list of active users. The System
Administrator accounts you just created is the only name on the list (the default System
Administrator account Kaye has been deleted). Now you are ready to add new users to
the system.
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3.3. Creating New User Accounts
When you create a new user account, the username is added to the active user list.
You assign a unique user ID for each user and a temporary password. The user has to
change the password on their first login. To create a user account:
From the Admin menu, press User Management and then press New User. The
New User screen becomes active.
Enter the new username in the Name textbox.
A user’s name is associated with the user ID that you enter in Step 3. The name
you enter here appears in the active user list.
Note: User IDs must be unique. Once a User ID name has been used, it cannot be
used again.
Enter the new account’s user identification in the User ID textbox.
The user ID can be 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
active account.
Enter a temporary password for the user in the Password textbox.
The temporary password can be any combination of numbers and characters.
The user is required to change this password when they first log in to the
program.
Enter the temporary password again in the Confirm Password textbox.
Note: A user account is not active until the user changes the temporary password
when logging into the Console for the first time.
Select the desired Title from the dropdown list.
Select the User Type from the drop-down, default User privileges are set based on
the User Type selected.
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Select any specific permissions you wish to give to a user. These permissions can
include for example:
Create setup
Stop study
View or edit reports
Press Save.
The User Management screen displays with the newly added username in the
user list.
3.3.1. Deleting and Disabling User Accounts
Other than active users (marked with green color in the user management screen),
there are two possible states for a user:
Disabled User
A user can be disabled by an Administrator or automatically disabled after three
consecutive login failures if enabled in the Policies (see 3.5 Setting Policies for details).
A disabled user’s account is marked in red in the user list. Users are listed in
alphabetic order. 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. Note, all actions are logged to the Audit Trail.
Deleted User
If a user’s account is no longer required an Administrator can delete the account by
pressing Delete at the bottom of the screen. To prevent discrepancies in the audit trail,
the deleted user’s ID is blocked for further usage. A deleted User does not appear in
the Users list however, the User’s ID and password are retained in memory so that
combination can never be reused. Note, all actions are logged to the Audit Trail.
Users List
Users List generates a pdf report that lists all active, disabled, and deleted user
information, along with their privileges, along with their assigned privileges.
User Search
For quick access, there is a search field that automatically filters for username. Please
not the field filters for the complete username as one expression. As an example, if you
enter “B” all usernames starting with a “B” are listed. If you would like to search for
“Bob Smith”, entering just “Smith” does not work.
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3.3.2. One Time Emergency Access
It is good practice to establish more than one active Administrator account. In case one
system administrator is not available anymore the system can still be maintained. If
Administrator access is no longer possible Kaye can provide one-time Emergency
access with the sole purpose of modifying an Administrator account. For this
procedure, direct support from Kaye service is required.
At the login screen, enter “Ctrl+e” into the password field to start the emergency login.
Please contact Kaye Support directly to receive required information. Emergency
access is logged in the audit trail.
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3.4. Setting Preferences
Figure 32: Preferences Tab in the Admin Menu
The Validator AVS software installs with default system settings. You can change the
settings on the Preferences screen.
The company name as entered, is displayed in all report headers.
Use the drop-down list to set the temperature units to Celsius or Fahrenheit. All
calculations are performed in the temperature units specified here. The IRTD and
the temperature reference (Kaye LTR, HTR or CTR product line) are also
programmed to operate in these units.
IMPORTANT: If a setup was created before changing units on the Preferences
screen, the software will prompt to change to the new settings the next
time the setup is saved. However, only the label will be changed, not
the temperature value. It is required to convert the temperature units
manually to the new temperature units. For example, if you created a
setup using °C, you may have entered 100.0°C as a calibration
setpoint. If you change the temperature units to °F, the software will
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change the calibration setpoint to 100.0°F, not 212.0°F, changing the
label from C to F but not the numeric value. If you want the setpoint to
be 212.0°F, go to the Calibration screen and change the temperature
value accordingly.
Select the absolute pressure units for saturated steam calculations from the
Pressure Units list box. If you selected “Other”, enter the value of 1 Atmosphere in
the absolute pressure units you are using.
Select 60 Hertz or 50 Hertz from the drop-down menu to set the line frequency.
Choose the setting that matches your environment.
IMPORTANT: The Validator AVS filters noise induced by the AC Power to achieve its
high accuracy performance. If the line frequency is not set correctly,
the filter is not working correctly, resulting in a higher signal noise level.
If necessary, you can enter an alternate machine identification number. The
machine ID appears in the audit trail for identification of the console.
Press Yes or No to indicate if you want to enable a user to change lethality
calculations parameters.
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, from 0.012 C to a maximum of 0.10 C.
Logo: Import of a custom logo that will be displayed in the report headers. It can be
any kind of bitmap and the preferable size is 90 x 30 pixel. Other formats will be
downsized.
Report Footer: Configuration if signature fields should be applied on first/last/every
page for setup, calibration and verification reports. For detailed and summary
reports, this is set in the report tool directly.
The path and folder holding the Data Directory is displayed.
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3.5. Setting Policies
Figure 33: Policies Tab
The Validator AVS software allows you to set security policies in order to comply with
company policies and/or 21 CFR Part 11 regulations. Allowing users more flexibility on
how to handle the password system, lethality D-Value and the calibration warning.
As the System Administrator, you can adjust policies that:
Require minimum length passwords for all user accounts.
Set passwords to expire after a defined number of days. The user will be
prompted to change their password once their current password has
expired. By default, passwords are set to expire after 180 days. The
software will display the password expiration date to the user at login
when there are five days or less until their password expires. Expired
passwords will not be accepted as new password again.
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Disable user accounts after three unsuccessful login attempts. This
option will disable a user account if there are three consecutive login
failures at the PC for the same user ID. If a user account is disabled, only
a System Administrator can enable the account again and assign a new
temporary password.
Disable User IDs during entry masks the User ID entry like the password
entry with dots in the login screen.
Disable the password system. User IDs and passwords will not be
required to use the software. If disabled, all Users in Audit Trail are
marked as "Unknown".
Require Special Characters will enforce a password with increased
strength by requesting at least one capital letter, a special character, and
a numeric character in the password. This feature is only available if
minimum number of characters criteria is set as well.
Allow editing the D value in the lethality calculation. When this option is
enabled, the D value field on the Lethality Calculations screen is editable
in the setup. If this option is not enabled, the D value field does display to
the default value of “1”, but is not editable when creating a new setup.
The instrument calibration warning sets a pre-warning interval for Kaye
Equipment populated under the Equipment tile (see Chapter 4 Defining
Equipment).
The Audit Sync In Users Before Sync Out feature, if enabled, it allows
automatic Sync-In for users prior to executing a manual or automatic
Sync-Out. Ensuring to Administrators that all Users on all AVS Consoles
are consistent and maintained.
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3.6. Updating the Validator AVS Firmware
Figure 34: Firmware Upgrade Tab
A new firmware release upgrade release for the Validator AVS can be applied using
the AVS Firmware Upgrade tool from the Admin functions. For upgrading the Firmware
please follow the steps exactly as outlined in the software:
Dock the console to the Validator AVS that is supposed to get upgraded.
Note: A remote upgrade using Ethernet or Wi-Fi is not supported!
Press the Get AVS SN number to establish a connection to the Validator AVS.
This assures the connectivity and retrieves the serial number for the audit trail
entry.
Insert a USB thumb drive with the firmware provided by Kaye into the USB port of
the Kaye console on the backside of the Validator AVS. You can easily identify the
correct USB port by referring to the displayed picture.
The firmware is ready to be upgraded, ensure that the Validator AVS is properly
powered and not powered off during the upgrade process. Failure to do so can
cause system damage and then restoration at a Kaye Service Center.
Press Upgrade Firmware and wait until a message displays to restart the
Validator AVS.
Note: Upgrading the AVS Operating system can take up to 15 minutes depending on
the amount of copied data. Please be patient and do not switch the Validator
AVS off before the corresponding message is displayed.
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3.7. Handling Data Files
High quality Document Management policies and Data Integrity guidelines require that
companies have the proper controls and procedures to backup and protect critical GxP
data.
The AVS system, under the File Management tile on the Main screen, has several
critical features that allow manual and automatic backup of critical Qualification data
files, reports, audit trail, and users. These features allow the backup, restoration, and
archiving of critical data to user define paths such as Mapped drives on the Network,
etc. Using these features creates the flexibility to define what data gets stored, where
it’s stored, and the frequency.
If you have multiple AVS Consoles or systems, utilizing these features you can setup a
common location where all Validation data from multiple Consoles can be merged.
The following rules apply to the Sync function when merging data:
Preferences and Policies are not synchronized
If two items with the same name exists, the item is updated with the latest version
(depending on the modified date) in case for users and assets.
If two items have the same name but different dates (reports, study files), both are
retained.
The sync operations are started from the File Management tile on the Main screen.
When starting a sync operation, the software firstly asks for the sync folder location.
Sync Out
The Sync out function is used to copy the data content of the console to another
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.
You can select data to be copied. If an asset is selected, the asset with all the
information (setups, study files, reports, documents) is copied. It is possible to
select only one or a few assets to transfer these from one console to another,
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but also possible to make a complete transfer with user, audit, equipment,
templates, and asset data, depending on the setup.
Figure 35: Sync Out Selection Box
Sync In
The sync in function copies data from a file location to the console. It can be
used to restore data of a backup generated with the Sync out or Archive
function. Like in the sync out function the user can select which data and which
assets are copied to the console. In addition to the Data selection there’s a date
filter to prevent old data to be copied to the console. The date filter specifies a
time frame with simple drop-down selection.
The copied data is merged with the existing console data.
Figure 36: Sync In - Date Filter
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Archive
The Archive function works like the Sync out function except it will not copy but
move files to a file location for archiving purpose, removing the files from the
console.
Therefore, in addition to the Sync out function there is an archive date. All files
that are older than the specified date is moved. Like in Sync out the assets can
be selected individually.
Figure 37: Archive Date Filter
AVS Convert
The AVS Convert function imports single study files into the Asset system of the
console. Single raw encrypted study files can be copied out of Asset Details for
importing into another console or sent by email. Study files copied using the
USB side port, copy the files in a single file format that requires importing into
the AVS software. The AVS Convert function is primarily used by Kaye
Technical Support. It allows customers to copy and send raw encrypted study
files via e-mail to Kaye for analysis or review.
To import a copied study file, select a single data file in the browser (if desired,
add a comment for easier identification). If the corresponding asset is not
currently in the system, the software creates a new asset and setup file from the
information stored in the study file.
Figure 38: AVS Convert – Import Comments
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Using Mapped Drives for Synchronization
The synchronization function can be used to share data via a mapped drive to a
server. Ensure that the mapped drive is correctly mapped in the Windows console.
Please note the following to ensure that synchronization performs properly:
It is recommended to enter the server address as 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.
Figure 39: Windows – Mapping a Drive
When syncing from the software to a mapped location from the Validator AVS
software:
Browse to the mapped drive. It is may be required to open the drive through the file
explorer and the entering windows credentials for access.
If credentials are required to login to the mapped drive, they are automatically
requested.
Enter your credentials for accessing the drive. If you are using a domain for security,
you can add the domain information after the username with an @ extension as
displayed in Figure 40 (alternatively the domain\user format is accepted as well).
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Figure 40: Mapped Drive Login Credentials
The security setup to access a shared folder is dependent on your network
environment. There are several scenarios:
The folder can be accessed without any restriction. If so, 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 your 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.
Auto Sync Function
The Validator AVS software can automatically data sync to a remote network folder in
a defined time interval. The setup for the sync location follows the same rules as
described in manual sync out.
The setup for Auto Sync is located under the Admin tile in “Auto Sync”.
Figure 41: Auto Sync Details
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The Validator AVS software can sync data automatically to a remote network folder in
a defined time interval. The setup for the sync location follows the same rules
described for manual sync out and using a mapped network drive detailed on previous
pages. Please note, Auto Sync expects a mapped drive on the network as the remote
folder. Local drives or USB drives cannot be used for automatic synchronization.
N/W Path: Browse to the mapped drive and folder to sync to. It may be required to
open through the file explorer and then enter your windows credentials for access.
User ID / Password: Enter your credentials to access the drive. If you are in a domain
security, you can add the domain information after the username with an @ extension
as shown below. Please use Test Connection to check if the user/password
combination works with the path.
Interval: That the interval and time the automatic sync out is set to start.
Auto Sync ON/OFF: Enable or disable the Auto Sync Function.
Test Connection: Pressing this button, the software checks if the entered path and
user credentials permit access, displaying a message accordingly.
Apply/Save: Once settings changes are complete, you can apply and test the
connection. For permanent use of the setup press Save. If you exit without saving the
old credentials are valid and any new credentials are lost.
The results of the Auto Sync function are logged in the audit trail. If the automatic sync
fails, a message with required user verification appears to ensure that operators are
notified.
Note: For the daily sync, it is only possible to save a sync time later than the current
time on the same day. As example if you want to auto sync at 6:00h in the
morning, you need to set it before 6:00h.
3.8. Online Help
For online help, utilize the AVS Console Pen and right click inside any screen or swipe
down from the upper right corner of the display. 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 AVS
application screen.
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Chapter 4. Equipment
Figure 42: Equipment Hub
The AVS software includes a unique feature called "Equipment" which allows users to
create an asset for each piece of Kaye equipment in their validation fleet.
Once entered, the AVS software alerts users with upcoming or overdue calibrations, as
well as automatically providing the name of each study where that piece of equipment
was used for a Qualification, Calibration or Verification.
Note: This feature can be valuable when experiencing “As Found” failures on any
yearly calibrations, as you no longer need to search through large amounts of
data to find where each piece of equipment was used.
Functional details:
A database of all used Kaye Equipment identified by serial number, calibration
information, and an optional picture.
Calibration reminders are based on the calibration reminder setting in preferences and
the calibration due date.
Search study files where certain Kaye equipment were used. The search is based off
the entered Kaye equipment serial ID and automatically retrieved serial numbers saved
within the study files. For temperature baths, no serial number is retrieved.
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4.1. Adding New Equipment
To add a new piece of Kaye equipment to your Equipment assets, press the Plus (+)
icon on Equipment screen. The New Equipment screen opens.
Figure 43: New Equipment Screen
Use the textboxes and drop-down menus to enter the following:
The equipment serial number as a unique identifier
Last calibrated date
Model number
Equipment type
Calibration due date
You can also upload an image of the equipment as a bmp or jpeg or access the
camera to take a picture directly.
When you have finished, press Save to save the entry and return to the Equipment
screen or Cancel to reset entries on the screen.
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4.2. Checking Details / Studies for Existing Equipment
To review the details and studies for a piece of Kaye equipment press the tile for that
item on the Equipment screen. The Equipment Details screen opens (it may take
several minutes to populate fully).
Figure 44: Equipment Details Screen
On the left side of the screen the listed details are as follows:
Serial number
Date of last calibration
Due date for calibration
Model number
Equipment type
Press the Pen icon to change any of these parameters. The left side of the screen
displays study files associated to this equipment.
On the left side of the screen, a list of where the equipment was used for
Qualifications, Calibrations, or Verifications is displayed. The list can be sorted by
study name or date and printed.
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Note: When a study is run, the AVS software obtains the serial numbers of the
equipment used and posts them to the Equipment Assets. Studies run before
the Equipment asset is created cannot be listed. Thus, it is important to list your
Equipment assets as soon as any new equipment is acquired.
In the funnel view, accessible from the equipment screen, it is possible to filter a list of
available studies by simply selecting the tile of the equipment.
4.3. Equipment - Calibration Reminder
The Equipment functionality provides a calibration reminder and visual alert to assist
users with the maintenance of their Kaye equipment.
When adding a new Equipment asset, the Calibration Due Date is manually defined.
Inside User Preferences the Administrator can define the number of months from the
due date to alert the Users. The number of equipment due for calibration is displayed
inside the Equipment tile on the Main screen.
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 5. Defining Assets
The Validator AVS includes an intuitive Asset Centric Data Management concept
(patent pending) where you can store and access your data faster and more efficiently.
Each individual process that you validate, whether an autoclave or freezer etc. can be
setup and defined as an asset. All files and data related to this asset, like setups,
calibrations, or study files are organized and accessed in one single screen around the
basic asset data. It is possible to upload additional documents like standard operation
procedures or certificates and associate it with the asset. Assets can be sorted and
searched by type, location, or manufacturer for easier access.
To open the Assets Hub, press Assets on the Main Menu. The Assets Hub displays,
as in Figure 45 below:
Figure 45: Assets Hub
The Asset Hub lists the various assets validated by your Validator AVS system. On the
top text line, you can press the category to display the assets by:
Type (sterilizer, dry heat oven, controlled temperature, etc.) up to 20
user-designated types
Manufacturer
Location
The asset tiles display each asset with type and model number. If the number of assets
exceeds the screen size, scrolling and zooming enables viewing additional assets.
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To search for an asset, press the Search (magnifying glass) icon, and enter the search
criteria / data.
For further details about a particular asset, press the tile for that asset to open its
corresponding Asset Details window.
To add one or more assets to the list, press the Plus icon (+) to open the New Asset
creation window. Press the Back icon (the left arrow) to return to the Main screen.
5.1. New Asset Screen
To enter a new asset into the Validator AVS system, go to the Asset Hub screen and
press the Plus (+) icon. The New Asset screen opens.
Figure 46: New Asset Screen
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Enter each new asset details separately, use the textboxes and drop-down menus to
enter:
The Asset Name: Asset names must be unique. Before synchronizing
several asset data sets, it is recommended to ensure there are no
duplicate asset names utilized. This field is mandatory and required for
unique identification.
The Equipment ID: Equipment IDs must be unique. This field is
mandatory and required for unique identification.
The type of asset: Any new type definition will be available in the drop-
down in the future. Please be careful as also test types or wrong spelled
types will be available in the drop-down. This field is mandatory and
required for sorting.
Manufacturer: Specify the manufacturers name of the asset. This field is
mandatory and required for sorting.
Location: Specify the location of the asset. This field is mandatory and
required for sorting.
Model: Specifies the model number of the asset. This field is optional.
Size: Specifies the volume of the asset in cubic units. In the drop-down, 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.
At the right, you can enter an optional Description of the asset. You can also upload up
to three images of the unit to appear on the Asset Details screen, as well as a wiring
overlay images that provides users of sensor placement on the asset.
When you have finished, press Save to save the entry and return to the Asset Hub or
Cancel to leave the screen without changes.
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5.1. Asset Details Screen
To learn more about a particular asset, select the tile for that asset on the Assets
screen. The Asset Details screen (shown below) opens:
Figure 47: Asset Details
In the upper left, the title is the asset type and name. The pane on the left displays a
picture and asset information defined during asset creation, details include:
Asset ID: The internal asset number or serial number for unique
identification of this asset.
Manufacturer: Asset manufacturer name
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.
Validation frequency.
In the right pane, tiles list the following categories associated with this asset:
Setups
Calibrations
Qualifications
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Verifications
Reports
Documents
A number on each tile represents the number of available files under this specific tile.
Selecting a tile highlights that tile and displays any associated files.
If more setup files are available, “Other" displays the number of additional setups.
Pressing the downward arrow opens the Setup List. On the list page, users can apply
predefined filter options (Status, Activity, Setup Name, Date, Comments, and Actions)
to sort the files.
The Setup tile displays the latest setup files. If more setup files are in the database, the
option, “Other Setups” displays the number of additional associated setups. Press the
downward arrow to open Setup List. On the list page, users can apply predefined filter
options (Status, Activity, Setup Name, Date, Comments, and Actions) to sort the files.
The New (+) button creates a new setup.
The Copy button permits the selected Setup to be copied to another Asset.
Pressing Copy opens a list of all available setups on the machine. Depending on the
number of assets and setups, the population of this list may take some time.
Assets are listed with names and with the setup name, number of sensors, comments,
and last modification date. Using the last column, you can select setups to copy to the
asset.
Use the Copy to Drive icon to copy a Setup to a USB to E-mail for service analysis.
For every setup the following action buttons are available:
Pencil: Permits editing an existing setup and saving under the same or
new name (the created date is different).
Wiring Map: Allows 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: Allows deletion of a setup (requires proper privilege assignment).
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The Setup tile is used to initiate Calibrations, Qualifications, and Verifications studies.
Simply select the Setup file and then the desired action to initiate.
The Calibration / Verification tiles lists all raw encrypted calibration / verification study
files. The file names include, the setup name, date, run number, and comments. After
selecting a Calibration / Verification study file, you can select Generate Reports to
open the report tool and create a report. Similar to the Setup files, the Calibration /
Verification raw encrypted data files can be deleted or copied to a drive provided
proper privileges.
The Qualification tiles lists all raw encrypted Qualification study files. The Qualification
tile has the same functionality options as the Calibration / Verification tiles.
The Reports tile lists all .pdf copies of the Setup, Calibration / Verification,
Qualification, and Pass/Fail reports generated in the reporting tool. The AVS software
automatically stores the reports in the Asset /Reports tile. Available reports can be
sorted by type for ease evaluation of year to year reports.
The Documents tile provides options to upload any pdf documents related to the
asset, e.g. wiring diagrams, SOPs, or calibration certificates.
The action buttons in the right corner allow editing the asset details (pencil) and 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.
The existing asset can also serve as a template for a new asset. Use the blue C button
to open the Copy Asset screen. It is required to enter a new name and ID for the asset.
Select certain available setups to be automatically copied to the new asset.
Figure 48: Copy Asset Screen
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Chapter 6. Defining Study Setups
Before you can run a qualification study, you must use the Validator AVS software to
create or modify a setup. A setup defines everything required to calibrate sensors and
run a qualification study.
Note: To create or modify a setup, you must have permissions established by your
System Administrator in the Admin menu (User Management tab).
The setup is accessed from the Asset Details screen, through the Setup pane. When
creating a setup:
Define the number and type of sensors to be used in the Qualification
study
Assign sensors to groups and generate a wiring diagram
Specify calculations and define group events to be monitored during the
qualification study
Specify calibration and verification setpoints
Specify temperature stability and deviation criteria for sensor calibration
and verification
Specify start and stop conditions for qualification and exposure cycle
Define output relays
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6.1. Create a Setup File
A setup defines everything required to calibrate sensors and run a qualification study
for a specific asset. Setup files are created in the Setup screens. To create setups,
permissions must be assigned by your System Administrator.
Figure 49: The Setup Hub Screen
To create a setup file:
From the Asset Details screen, press Setups. In the Setup Pane Hub, press New
Setup to enter the Study Details screen.
You can now define sensors, assign sensors to calculation groups, set calibration
parameters and criteria, specify the qualification cycle, and save your setup.
6.2. Modify an Existing Setup
Setup files for a specific asset are listed on the Setup screen. To modify an existing
setup file:
Select the setup file you wish to edit and press the Pen icon.
Note: You must have user permissions to modify a setup.
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6.3. Define Setup Screen
On the Asset Details Screen Setup Hub, select the Setup tile and then press New
Setup (+).
Figure 50: Define Setup Screen
On this screen, you define descriptive information to detail a Setup. Use the textboxes
or drop-down lists to enter:
The Setup Name
The Number of Sensors to be used in the Qualification study
The EQ ID
The SOP (Standard Operating Procedure) Protocol Number
The Load Description
Any Comments you wish to add.
Note: The Setup name, Study type, and Number of sensors fields are mandatory.
The Setup Name and Comment fields can accept alphanumeric characters and blanks;
the EQ ID, Load Description, and SOP fields can also accept special characters
(hyphen, underscore, forward and backward slashes.)
When all asset data is entered, press Sensors Configuration to continue.
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6.4. Sensors Configuration Screen
From the Study Details screen, press Sensors Configuration to open the Sensors
Configuration screen. Below the current Setup name, are rectangular boxes displaying
the seven Setup process steps. The box highlighted in orange displays the current
position in the process.
The Sensor Configuration process is broken down into two steps:
Select Sensors
Configure Sensors
Note: Sensor Configuration must match the actual wiring of the sensors to the SIMS.
The Sensor selection and configuration process must be repeated for each
type of sensor (T/C, RTD, Current, etc.).
Figure 51: Sensors Configuration Screen
The Sensors Configuration screen graphically represents the four Sensor Input
Modules labeled SIM 1, SIM 2, SIM 3, and SIM 4.
To configure, for example 24 thermocouples from SIM 1 and Sim 2, they must first be
selected. If the sensors are not in consecutive channels, you can select each channel
tile individually. As you do this the channels are marked with a checkmark indicating
they are selected.
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If the 24 sensors are in consecutive channels, an easier method is to define the range
of channels using the Select Sensors drop down. Simply, select the channel of the first
sensor and the channel of the last sensor and press Select. All channel in the range
are selected.
Now that you have selected the sensors, you must configure them for the appropriate
input type.
Figure 52: Configuring Sensors
Open the Configure Sensors drop-down list, and assign the selected sensors to one of
the following color-coded sensor types:
Thermocouples (T,J,K,E,B,R,S,N)
For most validation processes in the Pharmaceutical industry, Type T thermocouples
provide the best accuracy within the range of -200C to 350C.
It is recommended to utilize Type T (0.01C) resolution to maximize accuracy during
calibration and qualification.
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Voltage - the AVS system can accept inputs from other linear voltage
transducers (i.e. humidity, CO2, etc.). Refer to the calibration cert.
provided with the transducer and enter the input and output scaling
range. The acceptable input range is from -1V to 12V.
Current - the AVS system can accept inputs from other linear current
transducers (i.e. humidity, CO2, etc.) Refer to the calibration cert.
provided with the transducer and enter the input and output scaling
range. The acceptable input range is from 1 to 25ma. A 4-20ma SIM is
required for current inputs.
Pressure - the AVS system can accept inputs from a Kaye or other
pressure transducers. Select Voltage or Current, then select pressure for
pressure sensors and the units of pressure assigned in the Preferences
are utilized.
Contacts - the AVS system accept can dry contact inputs (no voltage
applied) inputs (switches, PLC's etc.). Calculations such as Lethality and
Start/ Stop Cycles such as Qualification and Exposure can be triggered
by Contacts inputs.
RTD - The AVS system accepts three and four wire 100-ohm platinum
RTD's utilizing the RTD SIM.
For pressure:
Once the sensor type has been selected, you can assign up to an 8-character label to
define the sensors and automatically numbered.
When that is completed press Assign to lock the sensor type. The SIM channels
update with the configuration and the channel tiles display the sensor type color.
Once the sensor type has been configured, you can press Description and enter up to
32 characters to provide a more detailed description. These can be used to define
sensor placement (i.e. top shelf, back left).
After sensor configuration, for each type of sensor type configured in your Setup, press
the Group Sensors tab to advance to the next screen.
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6.5. Understanding Groups
Grouping sensors is a powerful analysis and time saving tool that can be utilized for
your 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.
Sensors do not have to be in consecutive locations. You can assign any sensor from
any SIM to a group.
You must assign a sensor to a group to record data from that sensor. 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 overlay 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
temp variance and then having all sensors from all shelfs in separate
group for analysis.
Utilize groups to perform validation of four separate freezers at the same
time each containing 12 sensors.
These are but a few ways groups can enhance analysis and save time.
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6.6. Assigning Sensors to Groups
Figure 53: Group Sensors Screen
After the configuration of the sensors, the next step is to group them by pressing
Group Sensors. The Group Sensors screen displays a scrollable listing of existing
groups, as well as the New Group button.
As long there is no group defined, the Default Group button automatically generates
groups for sensors with the same measured variable, like temperature, voltage, and
Current etc.
To assign sensors to groups:
Select individual sensors to select them for the group. These sensors
now appear deep blue with an orange checkbox.
Press the New Group button, and the Group Name textbox appears on
the screen. The Group Name textbox accepts characters that can be
upper and lower case, numeric, special characters like hyphen,
underscore, slashes (forward and backward) and, blanks.
Enter a name and toggle the Save button to save the group.
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This screen also offers the following options:
Delete - permits deletion of a group of sensors
Move Sensors - permits moving sensors to another sensor group
(specified in drop-down list)
Customized Header for each group: The group specific header fields are
pre-populated with the information from the asset. The header can be
customized for each group. Any new information needs to be saved
using the Save button before switching to another group.
Add Sensors - add further sensors to a group
A Wiring Overlay – accessible via the Book icon - enables wiring overlay
configuration.
Figure 54: Wiring Overlay Diagram
Using the wiring diagram, you can define up to five pictures as background for placing
the sensor positions. After selecting a picture frame on the left side, a picture can be
loaded from a disk or taken with the built-in camera.
Note: When opening the camera, ensure that the software can access the camera.
The picture can be taken by double tapping the screen.
Sensor tags can be moved via drag and drop to the position reflecting the desired or
actual position on the asset. Wiring diagrams can be exported to a pdf using the
Printer button.
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For every group, it is possible to select a picture and a sensor position, then save it
together with the setup. The wiring diagram can be printed from the Wiring Overlay
screen or as a part of the setup report directly from the Asset Details screen. The
wiring diagram is used as the basis for the live mode layout view.
When you have finished, and saved your changes, press Calculations to proceed to
the Calculations screen.
6.7. Specifying Calculations
Figure 55: Calculations
Once you have defined sensors and assigned them to one or more groups, the next
step is to specify calculations to be performed during the qualification study.
Calculations include statistical, lethality, interval, saturation pressure of steam, and
saturation temperature of steam calculations.
Calculations for Statistical Lethality and Saturation are performed for all groups,
interval calculations can be specific for each group.
Note: If lethality is selected in the setup, the report tool requires the definition of an
exposure cycle as mandatory.
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It is also possible during report generation, to define events to monitor during the
study. These events are listed in the reports and can be used to define reporting tool
cycles.
When finished, press Calibration Parameters to enter the qualification parameters.
6.8. Specifying Calibration Parameters
Figure 56: Calibration Parameters Screen
The Validator AVS provides both sensor calibration and verification.
Before running a qualification study, regulations require performing sensor calibration
to maximize accuracy and ensure that the system meets required uncertainty criteria.
During sensor calibration, the Validator AVS automatically compares each sensor to
the IRTD (NIST-traceable temperature standard). The variation for each sensor at the
low and high calibration point is stored in the SIM as an offset. Offsets are then applied
to each sensor reading during the Qualification study. You can specify a two-point
calibration, or a two-point calibration with one check point.
Sensors that do not meet the User defined uncalibrated sensor criteria are marked as
failed and are not calibrated. Calibration and verification temperatures, chosen set
points, stability criteria, and deviation criteria all constitute a calibration signature.
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After the qualification study, it is recommended to perform a calibration verification to
verify that the sensor readings are still within the process criteria. You can specify a
one-point, two-point, or three-point verification independently from the calibration
criteria.
If a sensor fails verification, the sensor is noted as failed, but the readings are still
reported. Calibration offsets are not changed during calibration verification.
Set calibration parameters by specifying:
Temperature setpoints for calibration. You must specify a low setpoint
and a high setpoint and optionally, a check setpoint. If you specify low
setpoint and high setpoint, the high setpoint must be at least 2° higher
than the low setpoint.
Temperature setpoints for calibration verification to verify that each
sensor is still within your process criteria. You must select at least one
verification point during verification. Additional check points may be
defined during the actual Verification process.
Sensor and IRTD stability in terms of temperature variation over a fixed
time period. Stability is the amount of change that is acceptable over the
fixed time period.
Deviation criteria for uncalibrated temperature sensors, and deviation
criteria for calibrated temperature sensors over a fixed time period.
Deviation is the difference in temperature between the sensor values and
the temperature standard.
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6.9. Specifying Qualification Study Conditions
Specify the conditions that control your qualification study on the Qualification
Parameters screen. From this screen, you specify:
Qualification start/stop conditions - used to start and stop the qualification cycle
manually or automatically.
Exposure start/stop conditions - used to start and stop the exposure cycle manually or
automatically. Only applicable if Lethality calculation is defined.
Data storage options - the rates at which data is written to the disk during a
qualification run. Data is stored in the AVS hardware as a raw encrypted data file. All
calculations are based on the Storage rate. It is possible to have a faster storage rate
to enhance calculations and graphing and then also have a separate print rate when
you define the report.
Clock adjustment on qualification start – This feature aids in synchronizing the study
time with another device (i.e. PLC or controller of sterilizer). It allows a change of +/- 15
console time minutes to adapt e.g. to the time of an autoclave for parallel protocols in
sync. Please note, after the study start you should reset the time manually or use an
NTP server connection for automatic time setup. To utilize this feature, users must be
assigned this privilege by an Administrator.
Output relay - the events that activate the two independent output relays.
When you have finished, press Review to check your entries and save the setup.
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6.10. Reviewing and Changing the Setup
Figure 57: Setup Review Screen
After pressing Review, the Review screen opens, listing all the pertinent details about
the setup you have just created. The Review screen provides following actions:
Copy as New Setup —copy the current setup as a new setup and save it
under a different name.
Create Setup Report — creates a setup report as pdf file for saving and
printing.
This screen also displays the following sections, each with an Edit icon to permit rapid
changes:
Asset Details
Sensor Details
Calculation
Groups
Report Header
Calibration Parameters
Qualification Parameters
Press Save to save the setup or use Back to exit the Setup menu without changes.
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Chapter 7. Calibrating and Verifying Sensors
7.1. Introduction
Before you perform a qualification study, you should calibrate your temperature
sensors to correct raw temperature readings to a traceable temperature measurement
standard. You may also need to perform verification of the calibration to confirm the
accuracy of a qualification study.
You can perform automatic calibration only if your validation system includes a Kaye
temperature reference (Kaye temperature bath) and a Kaye temperature standard
(IRTD). The IRTD, a self-contained precision measurement standard that provides
data directly to the Validator AVS, accurately measures the temperature of the
standard. The IRTD provides a traceable standard that is used to correct the
temperature readings of your thermocouples. The Validator AVS automatically sets the
temperature reference to the specified setpoint (low, high, check), and automatically
reads the value of the IRTD at that setpoint.
In this chapter, you will be able to:
Load a setup into the Validator AVS
Select sensors to calibrate
Run calibration
The Validator AVS uses the calibration parameters defined in your setup to perform
sensor calibration. Calibration parameters specify the temperature reference setpoints
at which calibration is performed, and the stability and deviation criteria for the
temperature sensors and the temperature standard.
With the Validator AVS, you calibrate sensors at a low setpoint and a high setpoint.
When you start calibration, the Validator AVS computes the stability of the temperature
sensors and the temperature standard at the specified setpoint, according to the
parameters defined in your setup. When the temperature standard and all sensors
pass the stability criteria, the Validator AVS logs the stability readings to the calibration
report file. The Validator AVS then computes and logs deviation on the uncalibrated
sensors and calibrates all sensors that passed the deviation criteria. Finally, the
Validator AVS computes and logs deviation on the calibrated sensors for a specified
time.
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The Validator AVS repeats this process for both setpoints. You can also specify a
check point in your setup. During the check point, the Validator AVS calculates and
logs deviation on the calibrated sensors.
When calibration is complete, the Validator AVS writes the calibration offsets, the serial
number of the Validator AVS used for calibration, and the SIM slot number to the SIMs.
If a sensor fails at the low, high, or check setpoint, it is marked as failed in the SIM and
in the calibration report file.
Before you begin the calibration process:
Place the Validator AVS in a location with a stable and even temperature
and not exposed to any local heat sources (i.e. close to a sterilizer, an
open door causing a draft, etc.). Temperature variations and/or exposure
to external heat sources during calibration may cause temporary
temperature measurement errors.
To provide maximum accuracy during the calibration process, power up
the Validator AVS and let it run for approximately 30 minutes in the
operating calibration environment for the Validator AVS to acclimate to
the ambient temperature.
Using the IRTD cable, connect the IRTD to the AVS using the top slot of
the IRTD icon, located on the back of the AVS. To utilize the Temp
Reference, use the Temperature Reference cable to connect the Temp
Reference to the back of the AVS slot marked with a Temp Reference
icon.
Before you begin the calibration or calibration verification process, you must load your
setup into the Validator AVS. If a Kaye IRTD is used, connect the Kaye IRTD to the
upper port of the Validator AVS.
IMPORTANT: Connecting the Kaye IRTD to the lower connection port can result in
distorted data in the calibration reports. Ensure that you always use the
upper connection port!
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7.2. Loading a Setup into the Validator AVS
IMPORTANT: When you load a setup with a different calibration signature (calibration
parameters and/or temperature units) than the setup currently in
memory, any sensors already calibrated are marked as uncalibrated. If
you reload the original setup, and you have not calibrated sensors
using the new setup, the offsets are restored, and the sensors marked
as calibrated.
To load a setup:
From the Main Menu go to Asset Details and then select a setup to be used for
your Qualification study, from the list of available setups. Buttons for initiating a
study are active and pressing Initiate Calibration or Initiate Verification starts
the corresponding process.
Figure 58: Initiate a Calibration from Asset Setups
After pressing Discover, available devices are displayed. Select the Validator AVS to
be used for your Qualification study. Docking mode is preselected (highlighted in
orange), but it is possible to select any Kaye Validators AVS that is currently available
through a network connection.
Select the desired Validator AVS and press Connect. The Validator AVS then loads
the setup and reads sensor information. This process may take a few seconds to
complete. When completed, the Start Calibration screen displays.
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7.3. Selecting Sensors
You can select sensors to be calibrated or verified on the Select Sensors screen. This
screen (Figure 59 below) lists all thermocouple sensors defined in the setup. Sensors
that are not selected appear as plain blue, while selected sensors appear in their SIM
row in deep blue with an orange triangle. For each SIM, you can select sensors
individually or select all sensors in one step.
Figure 59: Sensor Selection Screen
To select sensors individually, press the individual sensor tile. The icon color
changes to deep blue and the checkbox is enabled.
After you have selected and confirmed your sensors, press Initiate Calibration
to start a new calibration, or Initiate Verification to perform a verification (press
Cancel to discard all sensor selections. Press Return in the upper left to exit.).
Note: Once you begin a new calibration, any offsets from previous calibrations are
lost.
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7.4. Calibrating or Verifying Sensors
Press Start on the Sensor Calibration screen to start a calibration study. The Validator
AVS automatically calibrates (or verifies) sensors at the setpoints defined in your setup.
In case of a verification, it is possible to change the checkpoint settings via the Criteria
button before starting a run to accommodate for any changes in requirements.
Hardware connections and criteria, as defined in the setup, can be reviewed any time
by pressing the corresponding buttons.
Note: It is recommended to ensure live data is displayed from connected sensors and
IRTD before starting a study.
Figure 60: Calibration Study Screen
When starting a calibration run the Validator AVS deletes all existing calibration offsets
stored in the SIMs for the selected sensors. Next, the AVS establishes communication
between the temperature reference and IRTD. The Calibration screen during the
calibration process displays temperature readings and stability readings for each
sensor being calibrated, IRTD temperature and stability readings, and the required
setpoint.
The header includes the study name, temperature point (high, low, or checkpoint), and
the Graph and List View icons. Under the header, three blocks correspond to the low,
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high, and check points, with temperature set points displayed at the top of the blocks.
Each block has an interior header, temperature, stability, and deviation. On the first
block, an additional header label lists the relevant data for
a particular
label (IRTD set
point, SIM number, sensor label) for each row. If the list exceeds the screen size, you
can scroll vertically through the remaining data. Use the Stop Calibration button to
stop calibration.
If the stability point for any sensor is reached, that point is replaced with a green
checkmark. However, if the deviation of any sensor is not within the specified limit, the
deviation appears in red.
Note: All calibration offsets are deleted from the SIMs if the calibration parameters or
temperature units of the new setup are different than the calibration parameters
or temperature units of the setup currently in memory.
Calibration offsets for sensors at each setpoint are written to the SIM when the
calibration process is complete. If you stop a calibration, calibration offsets already
calculated are not written to the SIMs, and the calibration report file is deleted.
7.4.1. Automatic, Semi-Automatic or Manual Mode
When you start a calibration, the Validator AVS software detects whether a Kaye
temperature reference and an IRTD are connected. The Kaye IRTD is required for
automatic or manual calibration. If the Temp reference is not detected, automatic
calibration is not possible, and the system automatically switches to semi-automatic
mode.
7.4.2. Calculate Stability
The first step in the calibration process is to ensure that the IRTD and sensors are
stable before we calibrate the sensors. Stability is the maximum allowable change in
temperature for each sensor and the temperature standard over a specified time
interval. The maximum allowable change in temperature for the IRTD is fixed at 0.012°C
(0.022°F) if all temperature setpoints are equal to or greater than 0.0°C (32.0°F). If any
temperature setpoint is less than 0.0°C (32.0°F), it is possible to change the IRTD
stability value manually in your setup, the allowable range is from 0.012 to 0.10° C .
The stability calculation begins once the temperature reference is within five degrees of
the setpoint. Sensor and IRTD readings are displayed on the Data screen with a red
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background until they reach stability. To achieve stability, the IRTD and all sensors must
meet the stability criteria defined in the setup.
All sensors and the IRTD must be stable (green) before the calibration process will
continue.
To terminate the calibration process, press Cancel.
7.4.3. Calculate Deviation of Uncalibrated Sensors
When the IRTD and all sensors reach stability, the Validator AVS calculates deviation
by comparing each uncalibrated sensor to the IRTD, and then logs the stability and
uncalibrated deviation data to the calibration report file. The Validator AVS marks any
sensor outside the deviation criteria as failed and those sensors should not be utilized
for the Qualification study. On the Qualification live screen this sensor label appears in
red. When uncalibrated deviation is complete, the Validator AVS calibrates all sensors
that passed uncalibrated deviation at the low setpoint.
7.4.4. Calculate Deviation of Calibrated Sensors
The Validator AVS then calculates calibrated deviation. Corrected results for each
sensor are compared to the IRTD, then logged, and displayed on the Data screen.
Sensors that fail the calibrated deviation evaluation display with a red background and
marked failed in the calibration report file.
7.4.5. Data Logging Complete at Setpoint
When the Validator AVS finishes logging the corrected results, it automatically sets the
Kaye temperature reference to the high setpoint and repeats the calibration process.
When the high setpoint calibration process is complete, the Validator AVS automatically
sets the Kaye temperature reference to the check setpoint. The only difference between
the low and high setpoint calibration and check setpoint is during check setpoint
calibration, offsets are not changed.
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