Kaye Validator AVS User manual

Validation
Kaye Validator ® AVS
User’s Manual
M5100-EN Rev. D
October 2016
Amphenol
Advanced Sensors

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Kaye Validator ® AVS
Thermal Process Validation System
User’s Manual
M5100-EN Rev. D
October 2016
Copyright © 2016 Amphenol Thermometrics, Inc.
967 Windfall Road
St. Marys, PA 15857-3333, USA
Web: www.amphenol-sensors.com.
Amphenol
Advanced Sensors

[No content intended for this page]

Contents
Kaye Validator AVS User’s Manual i
Chapter 1. The Kaye Validator AVS.............................................................. 1
1.1 Introduction....................................................................................................1
1.2 Validator AVS Benefits.................................................................................3
1.3 About this Manual.........................................................................................5
1.4 The Kaye Validator AVS System................................................................6
1.4.1 The Validator AVS Hardware..............................................................6
1.4.2 Sensor Input Modules (SIMs)..............................................................7
1.4.3 Plug-In Hardware Connections...........................................................8
1.5 The Validator AVS Software........................................................................9
1.5.1 User Access...........................................................................................9
1.5.2 User Identification.................................................................................9
1.5.3 Electronic Data Requirements..........................................................10
1.5.4 The Study Setup..................................................................................10
1.5.5 Sensor Calibration ..............................................................................11
1.5.6 The Qualification Study......................................................................12
1.6 Using the Validator AVS System..............................................................13
Chapter 2. The Validator AVS Hardware.................................................... 15
2.1 Introduction..................................................................................................15
2.2 The Validator AVS Instrument ..................................................................16
2.2.1 Connection Ports.................................................................................16

Contents
Kaye Validator AVS User’s Manual ii
2.2.2 Symbol Identification ..........................................................................17
2.2.3 Side Port for Data Transfer................................................................18
2.2.4 The Console.........................................................................................19
2.2.5 Internal Memory ..................................................................................20
2.2.6 Backup Battery....................................................................................21
2.3 Sensor Input Modules ................................................................................22
2.3.1 Wiring SIMs............................................................................................23
2.4 Kaye IRTD....................................................................................................31
2.5 Temperature Reference.............................................................................32
2.5.1 Sensor and IRTD Installation............................................................33
2.6 Connecting the System..............................................................................35
2.7 Setting the Validator AVS Time and Date...............................................36
2.8 Preventive Maintenance...........................................................................36
2.8.1 Fuse Replacement..............................................................................36
2.8.2 Calibration............................................................................................36
2.9 Transporting and Shipping ........................................................................37
Chapter 3. Creating User Accounts............................................................ 38
3.2.1 Creating New System Administrator Accounts...............................41
3.3 Creating New User Accounts....................................................................43
3.4 Setting Preferences....................................................................................46
3.5 Setting Policies............................................................................................48
3.6 Updating the Kaye Validator AVS Firmware...........................................49

Contents
Kaye Validator AVS User’s Manual iii
3.7 Handling Data Files ....................................................................................50
3.8 Online Help..................................................................................................53
Chapter 4. Defining Equipment................................................................... 54
4.1 Adding New Equipment..............................................................................55
4.2 Checking Details for Existing Equipment................................................56
4.3 The Calibration reminder...........................................................................57
Chapter 5. Defining Assets.......................................................................... 58
5.1 The Asset Details Screen..........................................................................59
5.2 The New Asset Screen ..............................................................................61
Chapter 6. Defining Study Setups .............................................................. 63
6.1 Create a Setup File.....................................................................................64
6.2 Modify an Existing Setup...........................................................................64
6.3 The Define Setup Screen ..........................................................................65
6.4 The Sensors Configuration Screen..........................................................66
6.5 Understanding Groups...............................................................................69
6.6 Assigning Sensors to Groups....................................................................70
6.7 Specifying Group Calculations..................................................................72
6.8 Specifying Calibration Parameters...........................................................73
6.9 Specifying Qualification Study Conditions .............................................75
6.10 Reviewing and Changing the Setup........................................................76
Chapter 7. Calibrating and Verifying Sensors........................................... 77
7.1 Introduction..................................................................................................77

Contents
Kaye Validator AVS User’s Manual iv
7.2 Loading a Setup into the Validator AVS..................................................79
7.3 Selecting Sensors.......................................................................................80
7.4 Calibrating or Verifying Sensors................................................................81
7.4.1 Automatic, Semi-Automaticor Manual Mode..................................82
7.4.2 Calculate Stability................................................................................82
7.4.3 Calculate Deviation of UncalibratedSensors..................................83
7.4.4 Calculate Deviation of Calibrated Sensors......................................83
7.4.5 Data Logging Complete at Setpoint..................................................83
7.4.6 The Graph View...................................................................................84
7.5 Current Calibration and Hardware Connections.....................................84
7.5.1 Reasons for CalibrationFailure.........................................................85
Chapter 8. Viewing Live Data....................................................................... 86
8.1 Select Validator AVS..................................................................................86
8.2 Monitoring Live Data...................................................................................88
8.3 Check CommunicationsConnections ......................................................93
8.4 Select a TemperatureStandard.................................................................93
Chapter 9. The QualificationStudy............................................................. 94
9.1 Introduction..................................................................................................94
9.2 Load a Setup................................................................................................96
9.2.1 Select a Setup File..............................................................................96
9.3 Viewing the Active Qualification Study.....................................................98
9.4 Graph Real-Time Sensor Readings and Calculations.........................100

Contents
Kaye Validator AVS User’s Manual v
Chapter 10. GeneratingReports................................................................... 102
10.1 Reports Overview......................................................................................102
10.2 Report Types..............................................................................................103
10.2.1 Setup Report......................................................................................103
10.2.2 Calibration Report .............................................................................104
10.2.3 QualificationReports.........................................................................104
10.2.4 Calibration Verification Report ............................................................106
10.2.5 Audit Trail............................................................................................107
10.3 The Reports Hub.......................................................................................111
10.4 The Report Analysis Screen....................................................................112
10.5 The Reports Details Screen.....................................................................113
10.6 The PerformanceAnalysis Screen .........................................................116
10.7 The Standard Reporting Screen .............................................................119
10.8 The Report Template Screen..................................................................119
10.9 The Add Cycles Screen............................................................................120
10.10 The ReportScreen................................................................................124
10.11 The GraphReportScreen...................................................................125
10.12 The Customize Calculations Screen.................................................128
10.13 The CustomizeGroupsScreen............................................................129
10.14 ReportOptionsScreen..........................................................................130
Appendix A. UnderstandingAudit Trail Events......................................... 132
Appendix B. EnvironmentalCompliance..................................................... 142

Contents
Kaye Validator AVS User’s Manual vi
B.2 Battery Disposal ........................................................................................144
B.2.1 What do the Markings Mean?..........................................................144
B.2.2 The Risks and Your Role in Reducing Them................................145
B.2.3. System Specifications ................................................................................146
B.3 FCC Part 15 details ..................................................................................147
Appendix C. Safety and Precautions........................................................... 148
Appendix D. Service information................................................................. 150

Chapter 1. The Kaye Validator AVS
Kaye Validator AVS User’s Manual 1
Chapter 1. The Kaye Validator AVS
1.1 Introduction
Figure 1: The 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 sensor
calibration and qualification reporting.
A complete Kaye validation package, which lets you perform a fully automated sensor
calibration, includes:
One or more Kaye Validator AVS
One or more Kaye Validation Consoles for programming and control

Chapter 1. The Kaye Validator AVS
Kaye Validator AVS User’s Manual 2
Up to four Kaye Sensor Input Modules (SIMs) per Validator (each SIM supplies up
to 12 thermocouple sensors)
A Kaye high temperature reference (HTR 400), a Kaye low temperature reference
(LTR –90, LTR –25/140 or LTR –40/140), or a Kaye cold temperature reference
(CTR –40 or CTR –80) for sensor calibration and verification
A Kaye Intelligent RTD probe (IRTD)
Premium grade thermocouples
Additional temperature and non-temperature sensors for qualification studies
(optional)
Users can select, and log in to, any Kaye Validation Console to communicate with any
Validator AVS, monitoring current studies and calibrations. Using the synchronization all
Assets, Studies, and Qualification data are visible across all Consoles. While a Console can
log in to one Validator at a time, multiple Consoles can log in to the same Validator AVS.
Users can disconnect a Console after initiating a study or qualification; also, any user with
any Console can stop a calibration or study currently running on any Validator AVS. Both
Consoles and Validator AVS’ can be on a user's local network, and users can obtain
software upgrades for the Consoles.

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Kaye Validator AVS User’s Manual 3
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 is used as the
operator interface to the Validator AVS.
Selectable input capacity (1 to 4 SIMs) up to 48 total inputs.
Robust Design
• Robust industrial design with two handles
• IPL55 rating, chemical resistant ABS housing
• Dedicated Validation Console for improved user interface
• On-board docking station for Kaye Validation Console
• Battery backup with field replaceable battery pack (max 3 hours)
Data Security via Smart Redundancy Concept
• Standalone operation of Validator AVS – console connection not needed
• Validator AVS Internal Memory
• Second independent mirrored memory card for data redundancy
• Data download to validation console
• Forced download of study and audit data to USB
• Backup and restore – synchronization of console data with server and other consoles.
Hardware Connectivity
The Kaye Validator AVS comes complete with improved robust connections for IRTD
and Calibration Baths. The Validator AVS is backward compatible with all existing
IRTD and Kaye Baths for Automatic Calibration. Two relay outputs are also available
to be activated via Qualification events.

Chapter 1. The Kaye Validator AVS
Kaye Validator AVS User’s Manual 4
Sensor Inputs
• Up to 4 SIMS: 48 channel capacity
• Scan speed of 36 channels per second / 48 channels 2 seconds
• SIMs for TCs, 4-20mA, 0-10V and RTDs
• Improved Sensor Connectivity (quick-fix & lock connectors)
• Accepts a wide range of thermocouple types (T, T premium, J, K, E, B, R, N, S)

Chapter 1. The Kaye Validator AVS
Kaye Validator AVS User’s Manual 5
1.3 About this Manual
The first part of this manual provides an overview of the Validator AVS hardware,
instructions for creating user accounts and entering asset and equipment information, and
an overview on using the Validator AVS software. The second part of this manual covers
using the Validator AVS, including calibrating sensors, running qualification studies, and
verifying sensor calibration.
The following is a brief description of each section 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 for
connecting the system.
Chapter 3 provides instructions for creating user accounts.
Chapter 4 provides instructions for entering Kaye equipment into the system.
Chapter 5 provides instructions for entering assets into the system.
Chapter 6 provides instructions for creating setups.
Chapter 7 provides instructions for performing calibration or verification.
Chapter 8 provides instructions for displaying live data on the Console.
Chapter 9 provides instructions for performing a qualification study.
Chapter 10 provides instructions for creating reports.

Chapter 1. The Kaye Validator AVS
Kaye Validator AVS User’s Manual 6
1.4 The Kaye Validator AVS System
The Kaye Validator AVS system integrates hardware and software, and gives you the
flexibility to design and run studies in the way you find most productive. This section
provides an overview of the system and its use.
1.4.1 The Validator AVS Hardware
The Validator AVS is a self-contained instrument, incorporating high-accuracy sensor
measurement hardware with secure data recording capability. It accepts programming and
control from one or more Kaye Validation Consoles. The Validator AVS provides standalone
functionality when calibrating sensors and running qualification studies.
Figure 2: The Validator AVS System
The Validator AVS accepts up to 48 inputs in any combination of thermocouple, voltage or
current inputs or 24 RTD inputs. The instrument is equipped with an universal power supply
(100-240 VAC) and connections for two Kaye temperature references (although only one
standard can be used at any given time), one Kaye temperature standard, and two contact
output for signaling a PLC or other devices.

Chapter 1. The Kaye Validator AVS
Kaye Validator AVS User’s Manual 7
1.4.2 Sensor Input Modules (SIMs)
The Validator AVS uses Sensor Input Modules to provide secure connection of sensors to
the Validator AVS while protecting the electronics from draft, dust, humidity, electrical
noise and mechanical shock. SIMs are designed to be wired once and used repeatedly.
You can wire SIMs yourself, or buy pre-wired SIMs to reduce preparation time. Once the
SIMs are wired, you can calibrate multiple harnesses at the same time and store them for
later use.
Figure 3: Sensor Input Module
The Validator AVS can be configured for up to 4 SIMs. Each SIM has:
•Sensor inputs: TC-SIMs have 12 sensor input connections, RTD SIMs can connect 6
RTD sensors, 4-20mA SIMs can connect 12 sensors and one connection for an
external power supply
•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
Using 4 SIMs, you can attach up to 48 inputs in any combination of thermocouples,
voltage, or current inputs. A dedicated 4-20 mA SIM is also available with 12 4-20 mA
inputs and one connection for an external power supply.

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Kaye Validator AVS User’s Manual 8
1.4.3 Plug-In Hardware Connections
The Validator AVS has connectors on the back of the unit for easy plug-in of SIMs,
temperature standards, temperature references. It also provides connection ports for
USB and Ethernet for the Console and the Validator. Another separate USB port is
utilized for the year device calibration USB with the ICAL software. The USB
memory card port on the left side of the instrument can be used to dump the 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
For a more complete description of the hardware, see Chapter 2, The Validator AVS
Hardware.

Chapter 1. The Kaye Validator AVS
Kaye Validator AVS User’s Manual 9
1.5 The Validator AVS Software
The Validator AVS software provides everything you need to perform validation
testing. Using the Validator AVS software, you:
•Create user accounts and assign user IDs, passwords and permission levels.
•Create validation study setups that run on the Validator. When calibrating sensors
and running qualification studies with the Console connected, the Validator AVS
software features expanded tools for graphing study data.
•Generate reports from secure data files that contain original calibration and
qualification data recorded during the study. Use the reporting utility to generate
reports containing only the results you need to document your study.
1.5.1 User Access
You can set user access to the Validator AVS to match the way your company works.
The Validator AVS software is designed user level has specific permissions that
define system access. Permissions can also be customized for each user.
1.5.2 User Identification
Each user is assigned two distinct levels of identification, user ID and password,
which are used to uniquely identify an authorized Validator AVS user. Each user ID is
associated with a unique user name to provide traceability during the validation
process.
The Validator AVS requires users to enter their user ID and password whenever they:
•Create, modify, or move a setup
•Change the setup stored in the Validator AVS
•Calibrate sensors or verify sensor calibration
•Manually start or stop a qualification study
•Change preferences
Whenever an action occurs that requires a user ID and password, the user name
associated with that user ID and a time stamp are written to the audit file along with a
description of the action.