Kaye Validator 2000 User guide

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A
Kaye Validator
User’s Manual
Validation
mphenol
Advanced Sensors
M4350E Rev. K
July 2014
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Page 3
A
Kaye Validator
Thermal Process Validation System
User’s Manual
M4350E Rev. K July 2014
mphenol
Advanced Sensors
Copyright © 2014 Amphenol Thermometrics, Inc.
967 Windfall Road
St. Marys, PA 15857-3333, USA
Web: www.amphenol-sensors.com.
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Contents
Chapter 1. The Kaye Validator
1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.2 Validator Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.3 About this Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
1.4 The Kaye Validator System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1.4.1 The Validator Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1.4.2 Sensor Input Modules (SIMs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.4.3 Plug-In Hardware Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
1.5 The Validator Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
1.5.1 User Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
1.5.2 User Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
1.5.3 Electronic Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
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 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Chapter 2. The Validator Hardware
2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
2.2 The Validator Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
2.2.1 Display Screen and Control Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
2.2.2 Connection Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
2.2.3 Symbol Identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
2.2.4 Internal Memory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
2.2.5 Backup Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
2.3 Sensor Input Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
2.3.1 Wiring SIMs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
2.4 Kaye IRTD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
2.5 Temperature Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
2.5.1 Sensor and IRTD Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
2.6 Connecting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
2.7 Setting the Validator Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
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2.8 Setting the Display Screen Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2.9 Viewing Calibration Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
2.9.1 Return to the Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
2.10 Preventive Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
2.10.1 Fuse Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
2.10.2 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
2.10.3 Display Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
2.11 Transporting and Shipping. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Chapter 3. Installing the Software and Creating User Accounts
3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
3.2 PC Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
3.3 Installing Kaye Validator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
3.3.1 Installation for a Network Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
3.3.2 Installation for a Local Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
3.4 Starting Kaye Validator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
3.4.1 Creating Your System Administrator Account . . . . . . . . . . . . . . . . . . . . . . . . . 59
3.5 Creating User Accounts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
3.5.1 Printing the User List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
3.6 Standalone Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
3.7 Selecting a Communications Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
3.8 Getting Help. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
3.9 Uninstalling the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Chapter 4. Calibrating Sensors
4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
4.1.1 Preliminary Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
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4.2 Performing a Standalone Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
4.2.1 Selecting the Disk Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
4.2.2 Loading a Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
4.2.3 Selecting Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
4.2.4 Calibrating Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
4.2.5 Rewrite Report to Disk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
4.2.6 Viewing Calibration Offsets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
Chapter 5. The Qualification Study
5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
5.2 Performing a Standalone Qualification Study. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
5.2.1 Loading a Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
5.2.2 Starting the Qualification Study. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
5.2.3 Viewing Real-Time Sensor Readings, Calculations, and Events. . . . . . . . . . .107
5.2.4 Viewing Historical Sensor Readings, Calculations, and Events . . . . . . . . . . .118
5.2.5 Reviewing Setup Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119
5.2.6 Starting and Stopping the Exposure Cycle. . . . . . . . . . . . . . . . . . . . . . . . . . . .122
5.2.7 Ending the Qualification Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
5.2.8 Rewrite Report to Disk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
5.2.9 Pausing Data Recording During the Qualification Study . . . . . . . . . . . . . . . .131
Chapter 6. Calibration Verification
6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135
6.2 Performing a Standalone Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . .137
6.2.1 Loading a Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .137
6.2.2 Selecting Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142
6.2.3 Verifying Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .145
6.2.4 Rewrite Report to Disk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149
Chapter 7. Specifications
7.1 Total System Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .153
7.2 Analog Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .154
7.3 Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .154
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7.4 Thermocouples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
7.5 Voltage Temp Coefficient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
7.6 Scanning Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
7.7 Input Impedance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
7.8 Compensator Temperature Coefficient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
7.9 Common Mode Rejection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
7.10 Input Terminal Temperature Non-Uniformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
7.11 Input Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
7.12 Max. Common Mode Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
7.13 Environmental Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
7.14 Relative Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
7.15 Normal Mode Rejection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
7.16 Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
7.16.1 Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
7.16.2 Fuse Rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
7.16.3 Voltage Input Resolution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
7.16.4 Size (H x W x D) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
7.16.5 Voltage Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
7.16.6 Weight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
7.16.7 Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
7.16.8 Real Time Clock Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Appendix A. Environmental Compliance
A.1 Waste Electrical and Electronic Equipment (WEEE) Directive . . . . . . . . . . . . . . . . 157
A.2 Battery Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
A.2.1 What do the Markings Mean?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
A.2.2 The Risks and Your Role in Reducing Them . . . . . . . . . . . . . . . . . . . . . . . . . 159
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Chapter 1. The Kaye Validator

Chapter 1. The Kaye Validator

1.1 Introduction

The Kaye Validator® is the latest generation in thermal validation systems. The Validator is a standalone thermal validation system designed to meet new regulations worldwide for validation processes. Combining Kaye’s precision thermal measurement hardware and data storage capability with proprietary Windows-based software, the Validator satisfies your calibration, qualification, and reporting requirements. When performing sensor calibration and qualification studies, you can operate the Validator in standalone mode or with a PC attached.
A complete Kaye Validator validation system includes:
The Validator instrument
The Validator software for Windows
®
7 and XP
A notebook or desktop PC (minimum Pentium 300 MHz with at least 256 MB RAM and
Microsoft Office 2007, 2010 (32-bit only) or 2013, and a printer that supports both portrait and landscape page orientation
Up to three Kaye Sensor Input Modules (SIMs)
A Kaye high temperature reference (HTR 400), a Kaye low temperature reference
(L TR-90, LTR -25/140 or L TR -45/140), or a Kaye cold temperature reference (CTR-80 or CTR-40)
A Kaye Intelligent RTD probe (IRTD)
Premium grade thermocouples
Additional temperature and non-temperature sensors for qualification studies (optional)
An Epson
calibration and the qualification study.
®
LX-300 printer (optional) attached to the Validator for printing during sensor
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Chapter 1. The Kaye Validator

1.2 Validator Benefits

The Kaye Validator brings important benefits to the validation process:
Designed to help meet FDA guidelines for protecting electronic data (21 CFR Part 11)
Fully validated software, hardware, and firmware
Measures and adjusts internal voltage continuously
Flexibility to operate as standalone or with a PC during testing
Built-in floppy disk drive (only in units built before July 2011) for loading setups,
collecting data, and upgrading firmware
Built-in USB flash drive interface for loading setups, collecting data, and upgrading
firmware
Over 2 MB internal memory to protect data in case floppy disk or flash disk fills up
Battery backup for up to 30 minutes if system loses power
Plug-in Sensor Input Modules minimize sensor handling and save calibration time
More flexibility to set up your test—assign sensors to groups to perform independent
calculations, perform distribution and penetration tests at the same time, or qualify multiple chambers
Test results are stored in secure data files that can only be accessed through the Validator
software
Generate easy-to-read, spreadsheet formatted reports from a single, protected file: raw data
is never modified
Export qualification data to an Excel spreadsheet file
Greater portability over other validation systems—weighs 20 pounds and includes a
carrying case
Network capabilities allow multiple PCs to store data files to the same location and use one
centralized database for user ID/password maintenance.
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Chapter 1. The Kaye Validator

1.3 About this Manual

This manual is intended to provide overview information on the Validator, instructions on getting started with the software, and step-by-step instructions on using the Validator in standalone mode.
The first part of this manual provides an overview of the Validator hardware, instructions for installing the software and creating user accounts, and an overview on using the Validator software.The second part of this manual covers using the Validator in standalone mode, including calibrating sensors, running qualification studies, and verifying sensor calibration.
For complete instructions on PC-controlled operation of the Validator, and instructions on creating setups and generating reports, see the Validator online Help.
The following is a brief description of each section of this user's guide:
Chapter 1 provides an overview of the Validator system.
Chapter 2 explains the Validator hardware and provides instructions for connecting the
system.
Chapter 3 provides instructions for installing the software and creating user accounts.
Chapter 4 provides instructions for calibrating sensors in standalone mode.
Chapter 5 provides instructions for performing a qualification study in standalone mode.
Chapter 6 provides instructions for performing calibration verification in standalone mode.
Chapter 7 contains the Validator specifications.
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Chapter 1. The Kaye Validator

1.4 The Kaye Validator System

The Kaye Validator 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 Hardware

The Validator is a self-contained instrument, incorporating high-accuracy sensor measurement hardware with secure data recording capability. The Validator provides standalone functionality when calibrating sensors and running qualification studies.
Figure 1: The Validator Unit
The Validator accepts up to 36 inputs in any combination of thermocouple, voltage or current inputs. The instrument is equipped with a universal power supply (100-240 VAC) and connections for two Kaye temperature standards (although only one standard can be used at any given time), one Kaye temperature reference, a PC, a USB to 9Pin Serial Port Adapter, a parallel printer for printing raw data during sensor calibration and the qualification study, and a contact output for signaling a PLC or other device.
The Validator includes a built-in USB flash drive interface and a floppy disk drive for loading setups, collecting data during the study, and upgrading firmware, a 12 line VGA display for viewing data during a study , over 2 MB of internal memory to protect data during a study, and a backup battery that protects data for approximately 30 minutes in case the system loses power.
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Chapter 1. The Kaye Validator

1.4.2 Sensor Input Modules (SIMs)

The Validator uses Sensor Input Modules (SIMs, shown in Figure 2 ) to provide secure connection of sensors to the Validator 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 2: Sensor Input Module
The Validator can be configured for up to 3 SIMs. Each SIM has:
12 sensor input connections
A memory chip to store calibration offsets, SIM serial number, slot location, and the serial
number of the Validator measurement board where calibration was performed
A cold junction reference RTD to maintain measurement accuracy in different
environmental conditions
Using 3 SIMs, you can attach up to 36 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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Chapter 1. The Kaye Validator

1.4.3 Plug-In Hardware Connections

The Validator has connectors on the back of the unit for easy plug-in of SIMs, temperature standards, temperature references, a printer, a memory card, and a USB to 9Pin Serial Port Adapter, for PC communication. An icon indicating the type of device identifies each connector.
Figure 3: Validator Connections
For a more complete description of the hardware, see Chapter 2, The Validator Hardware.
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Chapter 1. The Kaye Validator

1.5 The Validator Software

The Validator software provides everything you need to perform validation testing. Using the Validator software, you:
Create user accounts and assign user IDs, passwords and permission levels.
Create validation study setups that can be run standalone on the Validator or from a PC.
When calibrating sensors and running qualification studies from the PC, the Validator 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. You can also export qualification data to an Excel spreadsheet file for further analysis.

1.5.1 User Access

You can set user access to the Validator to match the way your company works. The Validator software is designed for three levels of users. Each user level has specific permissions that define system access. Permissions can also be customized for each user.
System Administrator - Responsible for the security of the program. The System
Administrator creates and maintains user accounts, sets site options, and backs up and restores
user information.
Supervisor - Creates and modifies setups, calibrates sensors, runs qualification studies, and generates reports. Supervisors can also change system preferences if the System Administrator has enabled the Allow Supervisors to change Preferences site option.
Operator - Uses prepared setups to calibrate sensors, run qualification studies and generate reports. Operators cannot change setups or system preferences.
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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 user. Each user ID is associated with a unique user name to provide traceability during the validation process.
The Validator requires users to enter their user ID and password whenever they:
Create, modify, or move a setup
Change the setup stored in the Validator
Calibrate sensors or verify sensor calibration
Manually start or stop a qualification study or exposure cycle
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 file along with a description of the action.
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1.5.3 Electronic Data Requirements

The Validator is designed to help you meet the guidelines for electronic signatures as specified in FDA Regulation 21 CFR part 11, Electronic Records; Electronic Signatures.
Two levels of identification - user ID and password
Uniqueness of each user ID
Users create their own passwords
User ID and password required whenever an action affects the security or integrity of the
data
Electronic signature identifies the user, and includes the date and time of the action
If the data is tampered with, the entire data file becomes inaccessible
Password expiration feature allows you to set a password expiration from 1 to 366 days
System Administrators can set a minimum-password length requirement
Option to disable a user account if there are three consecutive login failures for the
user ID
Secure audit trail files provide a complete listing of events that affect the integrity of the
Validator PC program and the Validator instrument. Audit trail files contain all events and identify the type of action performed, the date and time the action occurred, the name of the responsible operator, and any additional information required to understand the action taken.
The Validator software detects when files have been added or removed outside of the
program. When a discrepancy is detected, the software informs the user at startup and asks them to take responsibility for the added or missing file(s). If responsibility is denied, the software will continue to inform the user of the discrepancy when the software is launched. If responsibility is accepted, the software will request a user ID and password. Acceptance and denial of responsibility is logged in the audit trail.
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1.5.4 The Study Setup

The study setup defines everything required to calibrate sensors and run a qualification study. When you create a setup, you:
Define the sensors you are going to use in the study
Assign sensors to groups and specify group calculations
Define group events to be monitored during the qualification study
Enter group comments to be used in report headers
Specify calibration setpoints, temperature stability, and deviation criteria for sensor
calibration
Specify start and stop conditions for the qualification cycle and the exposure cycle
Specify how often to scan sensors
Specify how often to save and/or print qualification data
Define the output relay
After you have created and saved your setup, you run the study by loading the setup into the Validator via USB flash or floppy disk or by direct connection from your PC to the Validator. See the Validator online Help for instructions on setting up a study.
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1.5.5 Sensor Calibration

The Validator provides both pre-qualification sensor calibration and post-qualification 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 one-point calibration, a two-point calibration, or a two-point calibration and a one-point check. Sensors that do not meet the pre-qualification calibration test criteria are marked as failed and are not calibrated. Sensors that fail calibration 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 calibration criteria. You can perform a one-point, two-point or three-point post-qualification 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.
You can calibrate temperature sensors in standalone mode or from the PC using the Validator software. 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 your reference. If you do not have a Kaye IRTD, you can manually enter the reading of your temperature standard.
IMPORTANT: Standalone calibration requires a Kaye temperature reference and a
Kaye IRTD.
For instructions on standalone sensor calibration, see Chapter 4, Calibrating Sensors. For standalone calibration verification, see Chapter 6, Calibration Verification. For PC-controlled calibration and calibration verification instructions see the Validator online Help.
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1.5.6 The Qualification Study

During a qualification study, the Validator performs calculations and compiles data for your reports. You can run the qualification study in standalone mode or from the PC using the Validator software.
For instructions on running a standalone qualification study, see Chapter 5, The Qualification Study. For PC-controlled qualification studies, see the Validator online Help.
1.5.6a Report Generation
The purpose of qualifying equipment is to document its performance, either to satisfy regulatory requirements or to perform studies of your production processes. The Validator 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 software. You can create four different report types:
Setup Report
Calibration Report
Qualification Report
Calibration Verification Report
Each report is traceable to the original study data. You can export qualification data to an Excel spreadsheet file for further analysis.
Reports are not saved; you create reports each time from the secure data files. If a secure data file is tampered with, it is no longer readable by the software and you will not be able to generate reports.
For a more complete description of report generation, see the Validator online Help.
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1.6 Using the Validator System

The Validator system allows you the flexibility to design your qualification procedures to fit your workplace requirements. To perform a typical qualification study, Kaye recommends the following steps in order:
1. Use the Validator software to create a setup.
A setup defines the type of sensors and the validation parameters specific to your production
process. If you have pre-wired SIMs, assign your sensor locations according to the SIM configuration.
2. Print the Setup Report. Use the Setup Report to verify your validation parameters and as a reference for connecting
your sensors.
3. If you do not have pre-wired sensors, wire your thermocouples and auxiliary sensors to the
SIMs as based on the Setup Report.
4. Connect the hardware and confirm connections. Once the hardware is connected, use the Validator software to display a graphical
representation of your validation equipment to verify hardware and communications connections.
5. Load the setup into the Validator to calibrate sensors and run your study standalone, or you
can calibrate sensors and run your study directly from your PC.
IMPORTANT: The Validator is designed to run either as a standalone instrument or
PC-controlled. When calibrating sensors and running qualification studies, all major actions should be consistent. If the PC is connected, you should control sensor calibration and your qualification study from your PC. During sensor calibration and the qualification study, you can use the PC and/or the Validator to view data and track your progress.
6. With your hardware configured for the validation study:
Calibrate sensors against the temperature standard
Run the qualification study
Run post-qualification calibration verification
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1.6 Using the Validator System (cont.)
The Validator collects all study data and stores it in a secure data file internally, on USB flash or floppy disk, and in your PC's memory.
7. With the secure data file loaded on your PC, use the Validator software to design and
generate reports to document the specifics of your study. You can choose from two report utilities:
Kaye Validator now offers Report Wizard, a reporting utility that enables you to create
setup, calibration, calibration verification and qualification reports, and to export qualification data to an Excel spreadsheet file. With Report Wizard, you can edit the groups and sensors that appear in a qualification report, select cycles, change the layout of columns in the report, and add comments.
As an alternative, you can apply the basic reporting utility to generate the setup,
calibration, calibration verification and qualification reports. For qualification reports, enhanced graphing capabilities allow selecting and removing sensors, constants and calculations. You can also control graph colors, line styles and gridlines, and insert relevant text and illustrations.
In both utilities, you can access and print out the Audit Trail; you can apply filters based
on users, dates, Validators or serial numbers, and specific events.
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Chapter 2. The Validator Hardware

Chapter 2. The Validator Hardware

2.1 Introduction

The Kaye Validator comes equipped with a universal power supply, a power cord for 115 VAC (or 230 VAC as necessary), over 2 MB of internal memory, a 1.44 MB 3.5-inch floppy disk drive (only for units built before July 2011), a USB flash drive interface, a backup battery, and a soft carrying case. This chapter describes the Validator hardware and provides instructions for connecting the system. Included are sections describing:
The front of the Validator instrument, which has a display screen, controls for standalone
operation, and a floppy disk drive
The back of the Validator instrument, which has a USB flash drive interface and
connection ports for all system devices
Internal memory
Backup battery
Sensor Input Modules (SIMs), which are used to connect sensors to the Validator
The Kaye temperature reference, which provides the stable temperature required for
sensor calibration
The Kaye IRTD, a self-contained temperature standard
Connecting the system
Setting the Validator time and date
Setting the display screen contrast
Viewing calibration information
Preventive maintenance
Transporting and shipping
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2.2 The Validator Instrument

The Validator instrument is equipped with a display screen, control keys for standalone operation, a USB flash drive interface and a floppy disk drive, connection ports for all system devices, over 2 MB of internal memory, and a backup battery in case the system loses AC power.

2.2.1 Display Screen and Control Keys

The front of the Validator (shown in Figure 4 below) has a display screen, control keys (security, menu, and navigational) for standalone operation, and a floppy disk drive. Each of these is discussed below.
Display Screen
Menu Keys
Navigation Keys
Security Key
Figure 4: The Kaye Validator
2.2.1a Display Screen
The 12 line, monochrome VGA displays data in text only mode. If there is more data than can be displayed on the screen, you will see an up and/or down arrow at the bottom of the screen. Use the up and down navigational keys on the Validator keypad to scroll through the next or previous page of data.
You can increase or decrease the contrast of the display screen as necessary. See Adjusting the Display Screen Contrast later in this chapter for more information.
IMPORTANT: To clean the display screen, Kaye recommends that you use only a soft, dry
cloth. Do not spray liquid cleaner on the screen.
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2.2.1b Security Key
The security key (the key with the lock icon) prevents unauthorized access to the system. You must press this key whenever you are going to take an action that affects the Validator, such as:
Loading a setup
Calibrating sensors
Starting and stopping qualification
Starting and stopping exposure
When you press the security key , you are prompted for your user identification and password. Once you have identified yourself to the Validator, you can perform the desired action. All user logins are recorded in the audit trail and extracted to the PC program when the program establishes communication with the Validator.
2.2.1c Menu Keys
There are six menu keys (the blue keys). The functionality of each menu key is determined by the active display screen. Press a menu key to perform the action indicated by the label corresponding to that key.
2.2.1d Navigation Keys
There are four navigation keys (the arrow keys). These keys correspond to up, down, left and right. Use the up and down arrow keys to navigate within a screen when there is more data than fits on the display. Use the left and right arrow keys to move from screen to screen.
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2.2.1e USB Flash Drive Interface
The Validator is equipped with a standard USB flash drive interface and a standard 1.44 MB
3.5-inch floppy disk drive for loading setups, collecting data, and upgrading firmware. You can collect data over multiple flash or floppy disks during a qualification run, allowing you unlimited data storage capability . The flash drive or floppy disk drive is monitored at all times for faults and status.
The Validator is designed to write data to the USB flash drive interface or floppy disk drive. To provide data security, data is stored in secure data files that can only be read by the Validator software. Files that have been tampered with are no longer readable by the software.
IMPORTANT: Data will not be written to a disk drive for PC-controlled studies if the System
Administrator has selected the Disable Validator disk recording site option. See Setting Site Options in Chapter 3.

2.2.2 Connection Ports

The back of the Validator (shown in Figure 5 below) has ports for electrical and communication connections. Each connection port is labeled with an icon representing its function. The connection ports are defined on page 18.
RJ11 for IRTD
PC Serial Comm.
RJ11 for IRTD
RJ11 for Temp. Ref.
Parallel Printer
USB Flash Drive Interface
Relay NC/NO
USB Port (some versions)
Figure 5: Connection Ports
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2.2.2 Connection Ports (cont.)
Table 1: Connection Port Explanations
Icon Connection Port
RJ11 Connector
There are three 6-pin RJ11 connectors, labeled with a temperature reference icon, for connecting IRTDs and one Kaye temperature reference. ( any given time.)
USB Flash Drive Interface
For USB flash disk insertion.
Output Relay
There is one NO/NC relay output, labeled with a contact switch icon, for signaling a PLC or other device.
Relay Rating:
110 VAC ½ amp resistive load 24 VDC 2 amps resistive load 110 VAC ¼ amp inductive load 24 VDC 1 amp inductive load
Note: The Validator can accept data from only one IRTD at
Chapter 2. The Validator Hardware
PC Connector
There is one 9 pin D shell subminiature serial communications cable connector, labeled with a PC icon, for connecting a PC or notebook.
USB PC Port (some versions)
One USB PC connector, labeled with a USB icon, is available for connecting a PC.
Parallel Printer Connector
There is one 25 pin sub D connector, labeled with a printer icon, for connecting an Epson® LX-300 printer to the Validator for printing during sensor calibration and the qualification study. Use a standard Centronics printer cable to connect the printer to the Validator.
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2.2.3 Symbol Identification

Protective Earth Terminal
Caution (Refer to accompanying documentation.)
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2.2.4 Internal Memory

The Validator is designed to write data to internal memory, USB flash disk, floppy disk, and your PC hard drive (if connected) during sensor calibration and qualification studies. Qualification data resides in internal memory until you power down the system or load a new setup.
The Validator provides over 2 MB of internal memory to maintain qualification data during a study. When running a qualification study, internal memory can fill up quickly depending on the length of your study and your file rate (the rate at which data is written to internal memory , USB flash or floppy disk and the PC hard drive during a qualification run). File rates are limited to valid rates for the number of assigned sensors and the scan rate.
The Validator allows you to scan data at one of two rates during the qualification study: 8 inputs per second or 12 inputs per second. Each rate has a maximum file rate that is automatically determined based on the number of sensors being sampled, as shown below. (For further information, refer to the Validator Online Help topic, “Data Storage Rate.”)
The maximum file rate for an 8 inputs/second scan rate is determined as follows:
Number of Sensors Maximum File Rate
1 - 8 1.0 seconds
9 - 16 2.0 seconds
17 - 36 5.0 seconds
The maximum file rate for a 12 inputs/second scan rate is determined as follows:
Number of Sensors Maximum File Rate
1 - 12 1.0 seconds 13 - 24 2.0 seconds 25 - 36 3.0 seconds
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2.2.4 Internal Memory (cont.)
IMPORTANT: If 8 inputs/second is selected, the file rate for 17 - 36 sensors is 5 seconds due to
overhead processing.
When you create a setup, you select the file rate from a list of valid rates. If you choose to write data to internal memory at the maximum file rate, the internal memory can fill up quickly.
When data is deleted from internal memory, data already stored to disk or printed is not affected, however the amount of data that can be downloaded to disk at the PC after a standalone qualification study has ended may be affected.

2.2.5 Backup Battery

The Validator is equipped with a NiCad backup battery to provide short-term power in case of AC power loss. The intent of the battery is to provide sufficient time (approximately 30 minutes) so that you can perform an orderly shutdown of the system. When the Validator detects that the AC power has failed and the system is running from battery, it issues a message and then disables the Validator display backlight. You can momentarily re-enable the backlight by pressing any key on the unit.
IMPORTANT: In the event of power glitches or short-term drops in supply voltage
(“brownouts”), there is a remote chance that the Validator will fail to fall back to its backup battery. In this case the Validator will reset and potentially lose any study data stored in internal memory. To prevent this from occurring, Kaye recommends connecting the Validator to an Uninterruptible Power Supply (UPS) in areas likely to experience brownouts.
CAUTION! Power is still supplied to the unit via the backup battery after the AC
power cord is unplugged. Disconnect the W2005 cable from the battery pack before servicing the instrument.
The Validator monitors its own battery voltage. When the battery has approximately one minute of power remaining, the Validator stops collecting data and closes its data files. To ensure long service life and minimize the “memory” effect inherent in NiCad batteries, it is a good practice to completely discharge and recharge the NiCad battery on a periodic basis.
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2.2.5 Backup Battery (cont.)
To discharge the battery:
1. Turn the power switch on.
2. Disconnect the AC power cord.
3. Let the unit operate on battery power until the battery is completely discharged (the fan
will shut off when the battery is completely discharged).
4. Turn the power switch off.
To recharge the battery:
1. Connect the AC power cord.
2. Turn the power switch on.
3. Let the unit run for 3 hours to fully charge the battery.
A replacement battery pack, part number W2005, is available from Kaye.
CAUTION! Batteries must be disposed of in accordance with local, state
and federal regulations.
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2.3 Sensor Input Modules

The Validator plug-in Sensor Input Modules (SIMs) help reduce the time it takes to perform validation studies. Each SIM has:
12 sensor input connections
A memory chip to store calibration offsets, SIM serial number, slot location, and the serial
number of the Validator measurement board where calibration was performed
A cold junction reference RTD to help maintain measurement accuracy through changing
environmental conditions
Each SIM accepts T, J, and K type thermocouples as well as current and voltage inputs up to 10 VDC. Using 3 SIMs, you can attach up to 36 inputs in any combination of thermocouples, voltage, or current inputs.
SIMs are designed to be wired once and used repeatedly. You can wire SIMs yourself, or buy pre-wired SIMs to further reduce preparation time. Once the SIMs are wired, you can calibrate multiple harnesses at the same time and store them for later use, saving you valuable preparation time. Since calibration of thermocouples requires compensation for errors measured in fractions of microvolts, making these offsets specific to this instrument and SIM location, Kaye recommends that you use the supplied erasable labels to record:
SIM serial number
SIM slot number
Serial number of the Validator where the sensors were calibrated and the date they were
calibrated
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 will alert you during the qualification run that the SIM is plugged into the wrong instrument or the wrong 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. Make sure
all SIMs are connected prior to powering up the Validator, or you will have to power down, insert your SIMs, and power up again. If a SIM is disconnected after power up, that SIM's sensors will be read as Open and no data will be recorded for that SIM. To rectify this, power down, reconnect the SIM, and power back up.
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2.3.1 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. Kaye recommends that you wear an anti-static ground strap when connecting sensors and routing wires.
To connect sensors to SIM locations:
1. Loosen the two screws in the top of the module to open a SIM. Figure 6 below shows the
inside of a SIM.
1 1
2
3
4 5
Figure 6: SIM Wiring
Legend:
1 = Tie wrap mounts 2 = Connector (locations 1 - 6) 3 = Sensing RTD 4 = Connector (locations 7 - 12) 5 = Sensor location number. There are 12 connection locations, labeled 1 - 12, with a
positive and negative connector for each input.
2. Loosen the two retaining screws where the sensor is to be inserted.
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2.3.1 Wiring SIMs (cont.)
3. Connect your inputs. Valid inputs are:
Thermocouples J, K, T and premium T (see Connecting a Thermocouple later in this
chapter)
Contacts (see Connecting a Contact later in this chapter)
Voltage (see Connecting a Voltage Input later in this chapter)
Current (see Connecting a Current Transmitter With a Precision Shunt Resistor later in
this chapter)
4. Tighten the retaining screws.
5. Repeat Steps 2 through 4 for remaining sensors.
6. 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 7 below to maintain the thermal accuracy of the module.
1 1
2 2
2 3
Figure 7: SIM Wiring
Legend:
1 = Tie wraps provided by Kaye 2 = Tie wraps (optional - user-supplied) 3 = Drain hole
7. Tighten the two screws in the top of the module to close the SIM.
8. Label the SIM with SIM slot number, SIM serial number , the Validator serial number, and
the calibration date.
Note: To wire the dedicated 4-20 mA SIM, see document Z2036, “4 to 20 mA Sensor Input
Module.”
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2.3.1a Connecting a Thermocouple
Connect types J, K and T thermocouples to the connectors as shown in Figure 8 below. Cut through the outer insulation to separate the red and blue wires, and then strip back each wire approximately ½ inch in order to make the connection with the connector.
Figure 8: Thermocouple Connections
Always connect the positive (+) lead to the positive (+) connector and the negative (-) lead to
the negative (-) connector. The negative thermocouple lead is normally red, in conformance with ANSI standards.
Moist Heat Environments
When validating moist heat processes, a sealed PTFE tip thermocouple should be used with a drip cut (shown in Figure 9 below) on the outer insulation close to the SIM module to reduce the possibility of drawing moisture into the SIM. 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 (see Figure 9 below).
Figure 9: Drip Cut
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2.3.1a Connecting a Thermocouple (cont.)
Also, Kaye recommends shaving open about 1/4 inch from each of the red and blue inner wire jackets at opposite ends of the outer insulation drip cut to allow condensate drainage from within the individual wires, as shown in Figure 10 below.
Figure 10: Shaving from Inner Wire Jackets
If moisture does collect in the SIM, remove the SIM from the instrument, open, and allow to air dry before storage.
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2.3.1b Connecting a Contact
You can connect dry contact inputs directly to the SIM, as shown in Figure 11 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.
+
+
1
23456
+
+
+
+
Figure 11: 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 12 below.
Always connect the positive (+) lead to the positive (+) connector and the negative (-) lead to
the negative (-) connector.
+
1
+
+
23456
+
+
+
Voltage
Transducer
+ –
Figure 12: Voltage Input Connection
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2.3.1d Connecting a Current Transmitter With a Precision Shunt Resistor
A dedicated 4-20 mA SIM (discussed on the next page) 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 SIM. Connect a precision shunt resistor to the connectors to convert the current to a measurable voltage, as shown in Figure 13 below. Make sure the resistor you are connecting here and the value of the shunt resistor in your setup file agree. Kaye offers two resistors, 250 and 62.5 . The 250 resistor converts a 4-20 mA signal to 1-5V. The 62.5 resistor converts a 4-20 mA signal to 0.25-1.25V . Kaye recommends the 250 resistor.
Current
Transmitter
– +
Power
Supply
+
+
1
+
+
+
2345 6
+
+
Figure 13: Current Transmitter Connection

2.4 Kaye IRTD

The Kaye IRTD temperature measurement standard is a self-contained measurement system providing temperature data directly to the Validator software. The measurement accuracy is NIST-traceable to 0.025ºC, with a range of 183ºC 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 automatically reads and monitors the value of the temperature reference and the IRTD probe.
The IR TD probe is shipped from the factory with its baud rate set to 9600 and its address set to
01. The Validator communicates with IRTD probes with addresses 01 or 02. However, if both IRTD probes are set to 01, the system displays a communications error. The Validator also reports a communications error if an IRTD is disconnected from the unit during sensor calibration or a qualification study.
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2.5 Temperature Reference

Temperature references provide the stable temperature required for sensor calibration. Kaye has six temperature reference models available. They are designed to provide different temperature ranges and are compatible with the Validator.
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.
HTR 400 (setpoint range 25°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.
CTR -80 (setpoint range -80°C to 30°C) Recommended for calibration of sensors used in freeze dryers, freezers, and cryogenic units. The CTR -80 accepts up to 36 thermocouples.
CTR -40 (setpoint range -40°C to 150°C) 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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2.5.1 Sensor and IRTD Installation

The Kaye 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 will result in reduced accuracy during calibration.
The Kaye CTR -80 temperature reference has three thermocouple wells and two 12-inch nylon spacers to allow you to properly position your thermocouples and Kaye IRTDs.
LTR-90, LTR -25/140, LTR -40/140, and HTR 400 To insert thermocouple sensors into the LTR-90, LTR -25/140, LTR -40/140, and HTR
400:
For LTR-90, insert the thermocouple sensors through the rubber insulator first.
IMPORTANT: The LTR-90 comes with a rubber insulator. This rubber insulator must be used
at all times. If it is not used, Kaye does not guarantee specifications. Also, at cold temperatures, there will be significant ice buildup, that will 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-90, LTR -25/140, LTR -40/140, and HTR 400:
For LTR-90, insert the IRTD through the rubber insulator first.
Insert the IRTD very slowly 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 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 access cover, which is 7.5 inches wide, can be used as a measuring device in
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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2.6 Connecting the System

All system connections are on the back of the Validator. Make sure the unit is powered off before connecting the IRTD, temperature reference (LTR-90, LTR -25/140, LTR -40/140, HTR 400, CTR -80, or CTR -40), and SIMs
To connect your Validator, complete the following steps:
1. Connect the IRTD to one of the RJ11 sockets, using the M2810 cable supplied with the
IRTD.
2. Connect the temperature reference to one of the RJ11 sockets, using the W1885-1 cable
supplied with the temperature reference.
3. Insert the wired SIMs into their associated slot positions.
4. Insert the thermocouple sensors into the temperature reference. See the previous section,
Sensor and IRTD Installation, for installation instructions.
5. Connect your PC to the 9Pin Serial Port with the USB to 9Pin Serial Adapter provided.
6. (Optional) Connect a parallel printer to the 25-pin port. The Validator supports the
®
Epson the Validator.
LX-300 printer. Use a standard Centronics printer cable to connect the printer to
7. Connect the temperature reference power cable and the Validator power cable to a
grounded power source.
8. Turn the temperature reference power switch to the ON position.
9. Turn the Validator power switch to the ON position.
IMPORTANT: SIMs are only recognized by the system when you power up the Validator. If a
SIM is disconnected after power up, that SIM's sensors will be read as Open and no data will be recorded for that SIM. To rectify this, power down and power back up.
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2.7 Setting the Validator Time and Date

When the PC first establishes communication with the Validator, the current time and date are automatically transferred to the attached Validator. No action on your part is required. Refer to your Windows documentation for instructions for changing the date and time.
Note: If you change the time of day of the PC via the control panel on a Windows NT
operating system, restart the Validator PC program to update the time in the Validator.

2.8 Setting the Display Screen Contrast

Once your system is connected and powered on, you may have to adjust the contrast of the Validator display screen.
IMPORTANT: When the Validator is powered up, the last display screen contrast settings are
in effect. If the contrast settings make the display screen unreadable, press the left and right arrow keys simultaneously to restore the default settings.
The first screen that displays when you power on the instrument is the Validator screen, shown in Figure 14 below.
Validator Setup: Default Setup Date: 28-Jan-2005
G1: Distribution G2: Penetration G3: Pressure G4: Contact
Copyright© 1998-2006
Kaye
Main Menu

Figure 14: Validator Screen

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2.8 Setting the Display Screen Contrast (cont.)
To adjust the screen contrast:
1. Press Main Menu from the Validator screen. The Main Menu displays, as shown in
Figure 15 below
Main Menu
Real-time Data
Historical Data
Setup Review
Hardware Controls
Home

Figure 15: Validator Main Menu

2. Press
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Hardware Controls. The screen in Figure 16 on the next page displays.
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2.8 Setting the Display Screen Contrast (cont.)
Hardware Controls
Increase Contrast
Decrease Contrast
Pause Disk
Pause Printer
Engineering Log

Figure 16: Hardware Controls Screen

Home
3. Press Increase Contrast/Decrease Contrast as necessary to adjust the screen display.
4. Press Main Menu. The Main Menu screen redisplays.
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2.9 Viewing Calibration Information

Once your validation system is connected and powered on, you can view calibration information for your Validator and your SIMs. If you are using a Kaye IRTD and temperature reference, you can also view calibration information for your IR TD and temperature reference.
To view calibration information:
1. From the
below) displays.
Main Menu, press Setup Review. The Setup Review screen (shown in Figure 17
Setup Review
Sensor Definitions
Calculations and Events
Calibration Information
Summary
Main Menu

Figure 17: Setup Review Screen

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2.9 Viewing Calibration Information (cont.)
2. Press Calibration Information. The Calibration Information screen (shown in Figure 18
below) displays.
Calibration Information
System Calibration
Sensor Calibration
IRTD/Temp Ref
Review Menu

Figure 18: Calibration Information Screen

3. Press
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System Calibration. The screen in Figure 19 on the next page displays.
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2.9 Viewing Calibration Information (cont.)
System Calibration S/N: 00010007 MB S/N: 0499029 Calibrated: 07-Oct-2002 FW Version: 3.10 Setup: Default Setup Sensor Input Modules:
S/N Calibrated #1 12345678 01-Jan-05 #2 98765432 02-Jan-05 #3 34567876 03-Jan-05

Figure 19: System Calibration Screen

Chapter 2. The Validator Hardware
Cal Menu
The System Calibration screen identifies the Validator serial number, the measurement board serial number, the date this unit was calibrated, the installed firmware version, the name of the setup that currently resides in the Validator, and the serial numbers and calibration dates of the attached SIMs.
4. Press
Kaye Validator User’s Manual 41
Cal Menu. The Calibration Information screen (Figure 20 on the next page) displays.
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2.9 Viewing Calibration Information (cont.)
Calibration Information
System Calibration
Sensor Calibration
IRTD/Temp Ref
Review Menu

Figure 20: Calibration Information Screen

5. Press IRTD/Temp Ref. The IRTD/Temp Ref screen (Figure 21 below) displays.
IRTD/Temp Ref Time: Mon 11:06:08 Real-time Reading IRTD 1 IRTD 1: 90.0C IRTD 2: OFFLINE IRTD 2 Temp Ref: 90.3C
Temp Ref
Cal Menu

Figure 21: IRTD/Temp Ref Screen

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2.9 Viewing Calibration Information (cont.)
The IRTD/Temp Ref screen displays the current time and the real-time temperature readings for up to two IRTDs and your temperature reference. You can display more information about your IRTDs and your temperature reference from this screen.)
6. Press IRTD 1 or 2 to display more information about your IRTD. The IRTD Parameters
screen (Figure 22 below) displays.
IRTD Parameters
IRTD - 1
Address: 1 Probe ID: X2001V4.B Label: KL25/60-70125 Calibrated: 19-Oct-2006 User Label: (Displays User Label) Temp Scale: IPTS-68
IRTD/Temp Ref Menu

Figure 22: IRTD Parameters Screen

IRTD Parameters screen identifies the IRTD number (1 or 2) and the IRTD address (1 or
The
2), the probe ID and firmware version (Probe ID), the model number and serial number (Label), the date the IR TD was calibrated, and the temperature scale. User-defined information entered through the IRTD probe software displays in the User Label field.
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2.9 Viewing Calibration Information (cont.)
7. Press IRTD/Temp Ref Menu. The IRTD/Temp Ref screen (Figure 23 below) displays.
IRTD/Temp Ref Time: Tues 09:00:06 Real-time Reading IRTD 1 IRTD 1: 90.30C IRTD 2: OFFLINE IRTD 2 Temp Ref: 90.30C
Temp Ref
Cal Menu

Figure 23: IRTD Temp/Ref Screen

8. Press Temp Ref. The screen shown in Figure 24 below displays.
Temperature Reference Parameters Temp Ref - 1 Address: 1 Version: 3.51 Model: HTR-400 Cutot Temp.: 208 Setpoint: 90.00
IRTD/Temp Ref Menu

Figure 24: Temperature Reference Parameters Screen

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2.9 Viewing Calibration Information (cont.)
The Temperature Reference Parameters screen identifies the address of the temperature reference, the firmware version number, the temperature reference model number, the cutout temperature (the upper temperature limit the reference can reach), and the current setpoint.

2.9.1 Return to the Main Menu

Now that you have reviewed the calibration information, you can return to the Main Menu.
To return to the Main Menu:
1. Press IRTD/Temp Ref Menu.
2. From the IRTD/Temp Ref screen, press Cal Menu.
3. From the Calibration Information screen, press Review Menu.
4. From the Setup Review screen, press Main Menu.
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2.10 Preventive Maintenance

2.10.1 Fuse Replacement

The Validator is equipped with a 250V T 2A fuse. The fuse is located in the line filter along with the power cord.To replace the fuse:
1. Turn the power off.
2. Disconnect the power cord from the line filter.
3. Using a small, slotted screwdriver (provided with the SIMs), pry open the fuse holder
from the bottom tab.
4. Slide the fuse holder out and replace the fuse with a 250V T 2A replacement fuse.

2.10.2 Calibration

Kaye fully calibrates each Validator before shipment. The equipment normally requires no further adjustment or calibration during installation.
Under normal operating conditions, Kaye recommends you calibrate the Validator once a year to maintain peak system accuracy. If you use a Validator for high accuracy measurements, or if you replace or add circuit boards, you may need to certify the calibration more often.

2.10.3 Display Cleaning

To clean the Validator display screen, Kaye recommends that you use only a soft, dry cloth. Do not spray liquid cleaner on the screen.
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2.11 Transporting and Shipping

The Validator is designed to be easily transportable from one place to another within a plant. The unit weighs approximately 20 pounds, and comes with a soft case with a padded handle and shoulder strap. A zippered compartment accommodates small items such as a manual or power cord. You can order additional cases to carry your wire harnesses and accessories.
For shipping the Validator, you'll need a safe and durable container . Kaye can supply a rugged, foam-fitted case equipped with wheels and a collapsible handle to transport your Validator. Two compartments include a secure space for the instrument and accessories such as SIMs and cables. Contact the Sales Department at Kaye for pricing.
If you use another type of container, make sure the Validator is padded on all sides with four inches of cushioning filler.
If you need to return the Validator to Kaye 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. Installing the Software and Creating User Accounts

Chapter 3. Installing the Software and Creating
User Accounts

3.1 Introduction

Before using the Validator system, you have to install the Validator software on your PC and perform some basic system administration tasks.
The Validator software includes a Password Maintenance utility that allows a user with System Administrator permission to create and maintain user accounts and set site options.
A default System Administrator account is included with the software. You use this account to
initially log in to the Password Maintenance utility and create your own System Administrator account. The default account is deleted once your own System Administrator account is created. You can then use your own account to perform all your system administration tasks.
In this chapter you:
Install the Validator software configured for network or local applications
Start the program and log in to the Password Maintenance utility using the default System
Administrator account
Set site options
Create your System Administrator account
Create Supervisor and Operator accounts
Print the active user list
Select the Communications Port
Access the Validator online Help
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3.2 PC Requirements

To run the Validator Windows-based software, your PC should meet the following minimum requirements:
Pentium microprocessor with 300 MHz processor speed and at least 256 MB RAM
Microsoft® Windows 7 Professional (32 bit and 64 bit), or XP
Microsoft Office Professional 2007, 2010 (32-bit only) or 2013
One unused serial port or USB port for communicating with the Validator hardware (do not
configure any other programs, e.g., PDAs, to use the same serial communications port you have selected to communicate with the Validator)
Windows printer with graphical printer capability
Color monitor with a minimum of 256 colors and resolution at least 800 x 600

3.3 Installing Kaye Validator

Kaye Validator offers the option of configuring the software for network capabilities. The Validator data files can thus be saved to and reported on from a central network location, rather than stored on each individual PC's hard drive. In addition, by enabling network capabilities, the Validator software will utilize one central password database for managing user names and passwords. You can then manage passwords for all your users in one place, rather than having a different password database on each PC running the Kaye Validator software.
Follow these steps to install the Kaye Validator software. Before installing the software, you should close any applications that may be running.
If you are installing Kaye Validator to a network drive (from which you will install it to
individual PCs), proceed to “Installation for a Network Application” on the next page.
If you are installing Kaye Validator to an individual PC, proceed to “Installation for a
Local Application” on page 57.
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3.3.1 Installation for a Network Application

1. Be sure the network drive is mapped on your PC. On the drive, identify or create a network
location (folder) to hold the Validator installation and data files. This location will also provide a central database for managing user names and passwords. The folder should be protected against data deletion.
2. Insert the Validator CD into your CD-ROM drive.
3. If the installation does not automatically begin, complete the following steps:
Click Start on the Windows task bar, and then click Run.
Click Browse. From the Browse dialog box, select your CD-ROM drive, click Setup.exe,
and then click
4. Follow the on-screen instructions to perform the installation.
5. Click on the appropriate installation path to install Kaye Validator to the network drive.
6. Once installation has completed, the Kaye Validator Initialization program will run
automatically. The Kaye Validator splash screen will appear, followed by the System Administrator Site Options screen, as shown in Figure 3-1 on the next page.
Open.
When you start up the program for the first time, you will first set up the System Administrator Site Options. Afterwards, you will log in using the default System Administrator account and then create your own System Administrator account.
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3.3.1 Installation for a Network Application (cont.)
Figure 25: System Administrator Site Options
3.3.1a Setting up Site Options
The Site Options screen lists nine options that give users more flexibility while running the Validator software. These options are not mutually exclusive. You can enable any combination that your site supports. As the System Administrator, you can enable options that will:
Set a login timer for user identification. The login timer allows users, after initial
identification, to enter only their password if user identification is within the preset time limit. When this option is enabled, the login timer can be set from 1 to 15 minutes.
Require minimum-length passwords for all user accounts, from 6 to 16 characters.
Set passwords to expire after a number of days, up to 366. The user will be prompted to
change their password once their current password has expired. By default, passwords are set to expire after 90 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.
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3.3.1a Setting up Site Options (cont.)
Disable user accounts after 3 unsuccessful login attempts. This option will disable a user
account if there are three consecutive PC login failures for the same user ID. If a user's account is disabled, the System Administrator must enable the account and assign a new temporary password. This option does not affect logins from the Validator instrument panel.
Display a warning to calibrate the Kaye Validator (in months).
Allow users to specify the D value for lethality equations.
Disable Validator disk recording. When this option is enabled, the Validator will not write
data to a USB flash disk or floppy disk for PC-controlled studies. This option does not affect the loading of setups to the Validator via the disk drive.
This option applies to PC-controlled studies only. A disk is always required for studies
run in standalone mode.
When the option to disable disk recording is selected, any setups loaded to the Validator
or saved to disk from the PC program will be set to not record to disk. This means that any setups currently saved on a disk will need to be moved to the PC program and loaded to the Validator or re-saved to disk in order for the disable Validator disk recording option to take effect.
Disabling disk recording also disables the “rewrite report to disk” function.
When a loaded setup is set to not record to disk, the disk recording disabled icon
displays on the Validator instrument's display screen.
Disable the password system. User IDs and passwords will not be required to use the
software.
Note: If you select this option, the Kaye Validator system will not enable compliance with
21CFR Part 11 requirements for electronic records.To restor e this option, return to the Windows Start menu and click on Programs>Kaye Validator>Site Defaults.
Display User ID during entry. By default the user ID is shown to the user when logging in.
Clearing this option will replace the user ID characters with asterisks (*****).
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3.3.1a Setting up Site Options (cont.)
7. Click the check box next to any option that you want to enable. An X appears in the check
box when the option is enabled. Click the check box again if you want to disable it. The check box will be blank.
If you enabled the Allow timer for User ID entry option, the Time Interval readout
displays to the right of that option, and the timer is initially set to 5 minutes. You can set the timer from 1 to 15 minutes using the spin buttons.
If you select the Require minimum-length password option, use the spin buttons to set
the requirement from 6 to 16 characters.
The password expiration requirement can be set from 1 to 366 days with the spin
buttons. Click the spin buttons once to move in 1-day increments, or click and hold to move in 10-day increments.
8. Once your site options have been set, click on the
appears, as shown in Figure 26 below.
Figure 26: The Preferences Tab in the Site Options
Preferences tab.The Preferences screen
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3.3.1b Establishing Site Preferences
The Preferences tab has the following settings that can be initially set for all users who install Kaye Validator software from the network:
Select temperature units (Celsius or Fahrenheit) for all temperature calculations
Select the line frequency (60 Hertz or 50 Hertz)
Select the absolute pressure units for saturated steam calculations. If you selected Other,
enter the value of 1 Standard Atmosphere in the absolute pressure units you are using.
Allow users to specify the lethality criteria for calculation in reports
Select the COM port from the COM Port list box
Enter the Company Name
Specify the data directory, which will be the default location for storing and retrieving data
files and storing the password database. Navigate to the location on the network you identified to store the data files. This folder should be protected against file deletion.
9. Select the desired options, and click
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3.3.1c Completing Installation
10. Click Finish to complete the initialization program.
11. Return to the Windows task bar. Click Programs, then Kaye Validator, and then Client
Setup, shown in Figure 27 below.
Figure 27: Client Setup Program
in Kaye Validator Menu
12. Follow the on-screen instructions to complete the installation to the first PC.
Note: Once you have installed Kaye Validator to the first PC, and set up user accounts as
shown on page 61, you can return to the network initialization folder. Y ou can then run Client Setup to install Kaye Validator from the network to other PCs.
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3.3.2 Installation for a Local Application

1. Insert the Validator CD into your CD-ROM drive.
2. If the installation does not automatically begin, complete the following steps:
Click Start on the Windows task bar, and then click Run.
Click Browse. From the Browse dialog box, select your CD-ROM drive, click Setup.exe,
and then click
3. Click on the appropriate installation path to install Kaye Validator to your PC.
4. Follow the on-screen instructions to perform the installation.
5. Once installation has completed, the Kaye Validator Initialization program will run
automatically. The Kaye Validator splash screen will appear, followed by the System Administrator Site Options screen, as shown in Figure 25 on page 52.
6. Select the desired System Administrator Site Options and Preferences as described on
page 52, and click OK.
7. Click Finish to complete the initialization program.
Open.
8. Return to the Windows task bar. Click Programs>Kaye Validator> Client Setup.
9. Follow the on-screen instructions to complete the installation.
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3.4 Starting Kaye Validator

1. To open Kaye Validator for the first time, click Start >Programs>Kaye Validator>Kaye
Validator.
A control box opens similar to Figure 28 below.

Figure 28: Default Kaye Account Box

2. Click
Yes. The Identification Required dialog box (shown in Figure 29 below) appears.

Figure 29: Identification Required Box

3. Enter Kaye in the User ID text box. Kaye is the default System Administrator user ID. The User ID text box is case sensitive, so
make sure you enter the default user ID exactly as it appears here.
4. Enter 411 in the Current Password text box. 411 is the default System Administrator
password.
5. Click OK.
The Password Maintenance user screen appears (shown in Figure 30 on the next page). You can now create your own System Administrator account.
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3.4.1 Creating Your System Administrator Account

Figure 30: Password Maintenance User Screen
Once your System Administrator account is created, the default account you used to log on to the system (Kaye/411) will be deleted. You will then be logged in under the user name you create.
Note: At this point, the only options available are those for a System Administrator;
therefore, the user option buttons in the lower left are grayed out.
1. Enter your name in the
Name text box.
The name you enter here displays in the active user list. User names must be unique. Once you have added your name to the active user list, you can never use the same name again. Your name is associated with the user ID that you enter in step 2. You use your user ID and your password to log in to the Password Maintenance utility.
2. Enter your new System Administrator identification in the
User ID text box. 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.
3. Enter your new System Administrator password in the
Password text box. 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.
4. Enter your password again in the
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Confirm password field.
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3.4.1 Creating Your System Administrator Account (cont.)
At this point you should maintain a copy of your user ID and password in a manner acceptable to your local security procedures. You need both to log in to the Password Maintenance utility, to access reporting and to move or delete files. If you do not enter the correct user ID and password, you will be denied access.
5. Click OK. The Main Menu appears, as shown in Figure 31 below.
Figure 31: Validator Main Menu
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3.5 Creating User Accounts

The Validator is designed for three levels of users:
System Administrator - Responsible for the security of the program. The System
Administrator creates and maintains user accounts, sets site options, and backs up and restores
user information.
Supervisor - Creates and modifies setups, calibrates sensors, runs qualification studies, and generates reports. Supervisors can also change system preferences if the System Administrator has enabled the Allow Supervisors to change Preferences site option.
Operator - Uses prepared setups to calibrate sensors, run qualification studies and generate reports. Operators cannot change setups or system preferences.
In the previous section you created a System Administrator account. In this section you create Supervisor and Operator accounts.
IMPORTANT: A good practice is to establish more than one individual as a System
Administrator. This way the Password Maintenance utility functions can still be accessed even if one of the System Administrators is unavailable.
When you create user accounts, each user's name is added to the active user list. You assign a unique user ID for each user and a temporary password. The user will change the password when they first log in.
To create user accounts:
1. From the Main Menu screen, click Password Maintenance, and log in as a System
Administrator. The Password Maintenance screen appears similar to Figure 32 below. Note that the System Administrator account is the only user listed.

Figure 32: Password Maintenance Screen

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3.5 Creating User Accounts (cont.)
2. From the Password Maintenance menu, select Users>New User. The Password Maintenance dialog box, shown in Figure 33 below, displays.

Figure 33: Password Maintenance User Screen

3. Enter the new user name in the
Name text box.
The user name is associated with the user ID that you enter in step 3. The user ID is used to identify the user to the Validator software. The name you enter here appears in the active user list.
IMPORTANT: User IDs must be unique. Once an ID has been used, it cannot be used again.
4. Enter the new user identification in the User ID text box. The user ID can be any
combination of numbers and characters, up to a maximum of 16. The user ID and password are case sensitive. A user ID may not be used by more than one active account.
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3.5 Creating User Accounts (cont.)
5. Enter a temporary password for the user in the Password text box. The password can be any
combination of numbers and characters, up to a maximum of 16. The user will change this password when they first log in to the program.
6. Enter the temporary password again in the Confirm password text box.
IMPORTANT: If this user plans to use the Validator hardware in standalone mode, use the
numbers 1-5 only for the user ID, and inform the user to enter numbers from 1-5 when they create their permanent password. Standalone mode accepts the numbers 1-5 only.
At this point you should record the new user ID and temporary password. You will need to
supply this information to all new users. A user ID and password is required any time a user:
Changes preferences (if the System Administrator has enabled the user to modify
preferences, then other users can change preferences, otherwise the System Administrator is responsible for changing preferences)
Creates or modifies a setup
Changes the setup stored in the Validator
Calibrates sensors or verifies sensor calibration
Manually stops sensor calibration or calibration verification
Manually starts or stops a qualification study or exposure cycle
IMPORTANT: A user account is not active until users change their temporary password when
they log in to the PC program for the first time. Users will be unable to run the Validator in standalone mode if they have not changed their temporary password.
7. Set default user permission for this new account to Supervisor or Operator by clicking the
associated button.
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3.5 Creating User Accounts (cont.)
8. The Disable User Account option allows you to deny access to the system for this user . For
example, if you are creating an account for a user who will not need access to the system for several months, you may want to select this option to deny access to the user. You can de-select this feature once the user is ready to use the system (see the Validator online Help for instructions on editing user accounts).
9. Click any specific Permissions you wish to grant the user. While Operators or Supervisors
have certain standard permissions, you can modify a specific account so that the user can:
Create setups
Execute qualifications
Execute or verify sensor calibration
Create reports
Move or delete studies
View and print the Audit Trail
Modify preferences
Calibrate the Validator
Modify site options
Maintain passwords
10. Click
The Password Maintenance screen now appears similar to Figure 34 on the next page, with the new account listed.
Note: Use the scroll bar at the bottom of the screen to view additional information for user
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3.5 Creating User Accounts (cont.)

Figure 34: Updated Password Maintenance Screen

11. Repeat steps 1-10 to add more users to the system.

3.5.1 Printing the User List

When displayed on your PC monitor, the user list displays the active user accounts. The printed user list contains active and deleted user accounts, disabled user accounts, user accounts waiting for initial login, the name of the System Administrator that printed the list, the date and time the list was printed, the timestamp of the user list, and the machine ID.
Note: You can view deleted user accounts on your PC monitor by deselecting the Hide
deleted entries option from the File menu.
To print the user list:
From the Password Maintenance screen, select File>Print Users. The user list prints to your
default printer. It includes a date and time stamp, machine ID, the user table, permissions, disabled and deleted users.
To change your default printer:
From the Password Maintenance screen, select File>Print Setup. Select a new printer from
the list and click
The Password Maintenance screen displays. Select File>Exit to exit the Password Maintenance utility.
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3.6 Standalone Passwords

Once user accounts are created by the System Administrator with the Validator software, users running the Validator instrument in standalone mode can enter their user ID and password at the Validator instrument panel to run qualification studies, verify sensor calibration, and calibrate sensors, (provided that the user ID and password consist of numbers from 1-5, and the user has activated their account by creating a password through the PC program).
If users are running the Validator in standalone mode with the password expiration site option enabled, steps should be taken to ensure that users have the ability to change their passwords before they expire. The Validator firmware will reject expired passwords— users will need access to the Validator software in order to update them. A setup will need to be copied again to USB flash or floppy disk and transferred to the Validator instrument, or re-loaded directly to the Validator from the PC in order for the firmware to read the new user table with the updated password information.
Kaye recommends informing standalone users when their passwords are nearing the expiration date, allowing them time to use the software to change their password. For users who routinely access the Validator software, they will receive a prompt at login when there are five days or less until their password is set to expire.
It is possible that a user running a study in standalone mode could login with their user ID and password to start a qualification study, but be unable to stop the study because by that time their password has expired. In this circumstance, follow the steps below to safely stop the study without losing data:
1. On the Sensor Inputs - Real Time screen at the Validator instrument, press the Main Menu
soft key.
2. On the Main Menu, press Hardware Controls. Press Pause Disk on the Hardware Controls
screen.
3. Once the USB flash or floppy drive indicator light goes out, disk recording is paused. Eject
the flash or floppy disk from the drive. Insert a new disk in your PC's flash or floppy drive and start the Validator software.
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3.6 Standalone Passwords (cont.)
4. From the Main Menu, click the Preferences tab. At the Identification Required login screen,
enter the expired user ID and password and click OK. Change the password when prompted and return to the Main Menu.
5. Use the Validator software to copy a setup (it does not matter which one — the purpose is
to save a new user table only) to the disk.
6. Transfer the new disk to the Validator instrument's USB flash or floppy drive. The
Validator should be displaying a message confirming disk recording has been paused. Press Continue.
7. On the Hardware Controls screen, press Resume Disk.
8. Press the blue security key. The System Login screen appears.
9. Enter the updated user ID and password. At the Password Operations screen, press Stop
Qualification. Your qualification study data is now saved on two flash or floppy disks.
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3.7 Selecting a Communications Port

Note: If you have installed Kaye Validator from a network, the communications port may
have been already selected. You must have appropriate permissions to modify preferences.
You must select a communications port in order for the Validator to communicate with your PC. To select a communications port:
1. Click Start >Programs>Kaye Validator>Kaye Validator.
2. Click the Preferences tab at the top of the screen.
The Identification Required dialog box displays, shown in Figure 35 below.

Figure 35: Identification Required Dialog Box

3. Enter your user ID and the password supplied by your System Administrator and click OK.
If you are entering the program for the first time, you will need to change the password before you can exit the password entry box.
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3.7 Selecting a Communications Port (cont.)
The Preferences screen displays, as shown in Figure 36 below.

Figure 36: The Preferences Screen

Click the down arrow in the
COM Port list box to display the available communications ports
and select a port from the list.
IMPORTANT: Do not configure any other programs, e.g., PDAs, to use the same
communications port you have selected to communicate with the Validator.
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3.7 Selecting a Communications Port (cont.)
The selected COM port displays on the Preferences screen, as shown in Figure 37 below.

Figure 37: Preferences Screen with Selected Port

You can also select on the Preferences tab:
Temperature units (Celsius or Fahrenheit) for all temperature calculations
The line frequency (60 Hertz or 50 Hertz)
The absolute pressure units for saturated steam calculations. If you selected Other, enter the
value of 1 Standard Atmosphere in the absolute pressure units you are using.
The Company Name
The IRTD Stability Threshold
Whether you will use Report Wizard to generate qualification reports, and whether you can
merge ValProbe studies. Report Wizard is a reporting utility that enables you to create setup, calibration, calibration verification and qualification reports, and to export qualification data to an Excel spreadsheet file. With Report Wizard, you can edit the groups and sensors that appear in a qualification report, select cycles, change the layout of columns in the report, and add comments. (Please note that if you do not select Report Wizard, you will not be able to merge ValProbe studies.)
Select the desired options, and click
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3.8 Getting Help

There are four ways to get help while using the Validator software:
Help Screen—Click the Help tab to access the Help screen. From the Help screen you can access the online help Contents and Index.
Help Button—Click the help button on any screen to display online help for the currently active screen.
F1 Function Key—Position the cursor on the field or control that you want help on, or tab to that field or control, and press the F1 function key to display context sensitive help for that field or control. If that field or control does not have its own help topic, the help topic for the active screen displays.
Status Messages—When you move your cursor over a control or item on the screen, a brief status message appears at the bottom of the screen.

3.9 Uninstalling the Software

If for any reason you need to uninstall the Validator software, access the Validator uninstall program through Windows.
To uninstall the software:
1. Click Start>Settings>Control Panel.
2. Double-click Add/Remove Programs.
3. Select Kaye Validator from the list of programs, and click Change/Remove.
4. Follow the on-screen instructions to uninstall the software.
5. Select Kaye Validator Initialization from the list of programs, and click
Change/Remove.
6. Follow the on-screen instructions to uninstall the software.
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Chapter 4. Calibrating Sensors

Chapter 4. Calibrating Sensors

4.1 Introduction

Before you perform a qualification study, you should calibrate your temperature sensors to correct raw temperature readings to a traceable temperature measurement standard.
The Kaye Validator can perform standalone or PC-controlled calibration:
You can perform standalone calibration only if your validation system includes a Kaye
temperature reference and IRTD.
You can perform PC-controlled calibration automatically if your validation system includes
a Kaye temperature reference and IRTD, or manually if your validation system does not include a Kaye temperature reference and/or IRTD.
IMPORTANT: The Validator is designed to run either as a standalone instrument or
PC-controlled. When calibrating sensors, all major actions should be consistent. If the PC is connected, you should control sensor calibration from your PC. During sensor calibration you can use the PC and/or the Validator to view data and track your progress.
The Validator 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. See Specifying Calibration Parameters in the Validator online Help.
The Validator allows you to calibrate sensors at a low setpoint, a high setpoint, or both. When you start calibration, the Validator 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 logs the stability readings to the calibration report file. The Validator then computes and logs deviation on the uncalibrated sensors, and calibrates all sensors that passed the deviation criteria. Finally, the Validator computes and logs deviation on the calibrated sensors for a specified time period. If you are performing a two-point calibration (low and high setpoints), the Validator repeats this process.
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4.1 Introduction (cont.)
You can also specify a check setpoint in your setup. During check setpoint, the Validator calculates and logs deviation on the calibrated sensors. Calibration offsets are not altered unless a sensor fails at the check setpoint.
During the calibration process, the Validator writes calibration data to the USB flash or floppy disk drive, the PC hard drive (if calibration is PC-controlled), and to the Validator printer (if attached).
Note: Data will not be written to the disk drive for PC-controlled calibrations if the System
Administrator has enabled the Disable Validator disk recording site option. See Setting Site Options in Chapter 3.
When calibration is complete, the Validator writes the calibration offsets, the serial number of the Validator measurement board where calibration was performed, 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.

4.1.1 Preliminary Steps

Before you begin the calibration process:
Place the Validator in a location with stable and even temperature, 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 and
let it run for approximately 30 minutes in the operating environment where calibration is to be performed in order for the Validator to acclimate to the ambient temperature.
Place the temperature sensors and the IRTD into the temperature reference. The
temperature reference provides the stable temperature required for sensor calibration. The IRTD, a self-contained precision measurement standard that provides data directly to the Validator, accurately measures the temperature of the reference. The IRTD provides a traceable standard that is used to correct the temperature readings of your thermocouples.
This chapter provides instructions on performing a standalone sensor calibration. For instructions on performing a PC-controlled sensor calibration, see the Validator online Help.
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4.2 Performing a Standalone Calibration

You can perform standalone calibration only if your validation system includes a Kaye temperature reference and IRTD. The Validator 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 section you:
Load a setup into the Validator
Select sensors to calibrate
Run calibration
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4.2.1 Selecting the Disk Storage

To set the type of disk on which you will store data (either floppy (for units built before July
2011) or USB):
1. Press the Security Key. The System Login screen, shown in Figure 38 below, displays.
System Login
User ID: 1 > Password: 2
3
4
5
ENTER
Figure 38: System Login Screen
2. Key in your user ID and press
ENTER.
3. Key in your password and press ENTER.
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4.2.1 Selecting the Disk Storage (cont.)
The Password Operations screen, shown in Figure 39 and Figure 40 below , displays. To select the type of storage you need (floppy or USB Disk), press the Select (Floppy or USB) Disk
Storage entry to alternate to the desired storage medium.
Password Operations
Load Setup
Calibrate Sensors
Start Qualification
Select Floppy Disk Storage
Main Menu
Figure 39: Password Operations Screen
(for Selecting Floppy Disk Storage)
Password Operations
Load Setup
Calibrate Sensors
Start Qualification
Select USB Disk Storage
Main Menu
Figure 40: Password Operations Screen
(for Selecting USB Disk Storage)
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4.2.2 Loading a Setup

The first screen you see after the unit has been powered up is the Validator screen. This screen lists the setup currently loaded in the Validator. If the Validator screen is not the current screen, press Main Menu. From the Main Menu, press Setup Review, and then press Summary. The currently loaded setup displays on the Validator screen, shown in Figure 41 below.
Kaye Validator Setup: Default Setup Date: 28-Jan-05
G1: Distribution G2: Penetration G3: Pressure G4: Contact
Copyright© 1998-2006
Kaye
Main Menu
Figure 41: Summary Screen
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4.2.2 Loading a Setup (cont.)
If the setup loaded in the Validator is the one you are going to use for calibration, go to the next section, Selecting Sensors.
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 will be 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 are marked as calibrated. When you load a setup with a different line fr equency than the setup curr ently in memory, you must wait for the Validator to stabilize (approximately 2 - 3 minutes) before calibrating sensors or you may see invalid sensor data displayed. You can also turn the Validator off and then back on, and then calibrate your sensors.
To load a setup:
1. Insert the USB flash or floppy disk that contains your setup into the Validator USB flash
drive interface or floppy disk drive.
In addition to setup data, the disk contains the user list and the machine ID of the PC that saved the file to floppy or flash.
2. Press the Security Key.
When you press the Security Key, the Validator reads the machine ID of the PC from the disk.
If the machine ID on disk is the same as the machine ID in internal memory, the
Validator compares the date of the user list on the disk to the date of the user list in
internal memory. If the user list on the disk is more recent than the one in internal memory, the Validator replaces the user list in internal memory with the one from the disk.
If the machine ID on disk does not match the machine ID in internal memory, the user
list on the disk replaces the user list in internal memory.
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4.2.2 Loading a Setup (cont.)
When the Validator finishes comparing the machine IDs and user lists, the System Login screen, shown in Figure 42 below, displays.
System Login
User ID: 1 > Password: 2
3
4
5
ENTER
Figure 42: System Login Screen
3. Key in your user ID and press
ENTER.
4. Key in your password and press ENTER.
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4.2.2 Loading a Setup (cont.)
The Password Operations screen displays, as shown in Figure 43 below.
Password Operations
Load Setup
Calibrate Sensors
Start Qualification
Select Floppy Disk Storage
Rewrite Report to USB Disk
Main Menu
Figure 43: Password Operations Screen
5. Press
Load Setup.
The Validator displays the setup files that reside on the disk and, for each setup, displays the setup name, the name of the Supervisor who last saved the setup, and the date and time the setup was saved, on the Setup List screen, shown in Figure 44 on the next page. The setup names appear in reverse video.
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4.2.2 Loading a Setup (cont.)
>Steam Sterilizer Prev John Doe 03-Apr-2005 Mon 10:34:55 Next Penetration Study John Doe Load 31-Apr-2005 Fri 14:32:44 Distribution Study John Doe 31-Apr-2005 Fri 14:02:25
Main Menu
Figure 44: Setup List Screen
Setup List
6. If there are multiple setups on the disk, use the up and down arrow keys on the Validator
keypad, or the Next and Prev buttons on the Setup List screen, to select your setup. The pointer (>) appears to the left of the selected setup.
7. Press Load. It takes a few seconds for the Validator to load the setup. When complete, the Sensor
Inputs-Real Time screen displays.
The next step is to select the sensors to be calibrated.
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4.2.3 Selecting Sensors

The sensors you select for calibration will have any previous calibration offsets deleted from the SIMs when you start calibration.
To select sensors for calibration:
1. If you have not entered the Password Operations screen, press the Security Key to enter the
System Login screen, shown in Figure 38 on page 76.
2. Key in your user ID and press ENTER, and then key in your password and press ENTER.
3. Press Calibrate Sensors.
The Sensor Selection screen displays. This screen, shown in Figure 45 below, lists all the temperature sensors defined in your setup. The SIM numbers and sensor locations of uncalibrated sensors display in reverse video.
Sensor Selection
>All Sensors Criterion
I-01 Temp 01 I-02 Temp 02 Select I-03 Temp 03 I-04 Temp 04 Deselect I-05 Temp 05 I-06 Temp 06 Continue I-07 Temp 07 I-08 Temp 08
Main Menu
Figure 45: Sensor Selection
4. Select the sensors you are going to calibrate. You can select sensors individually or select
all sensors in one step.
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4.2.3 Selecting Sensors (cont.)
To select sensors individually, use the up and down arrow keys on the Validator keypad
to position the pointer on the individual sensor and press to the right of the selected sensor, indicating this sensor is to be calibrated.
Select. An asterisk (*) appears
To select all sensors in one step, use the up and down arrow keys on the Validator
keypad to position the pointer on the right of each sensor, indicating all sensors are to be calibrated.
Note: You can deselect sensors individually or deselect all sensors in one step using the
Deselect button.
In the example shown in Figure 46 below, sensors 1-01 through 1-04 have been selected.
>All Sensors Criteria
I-01 Temp 01* I-02 Temp 02* Select I-03 Temp 03* I-04 Temp 04* Deselect I-05 Temp 05 I-06 Temp 06 Continue I-07 Temp 07 I-08 Temp 08
All Sensors and press Select. An asterisk (*) appears to
Sensor Selection
Main Menu
Figure 46: Sensor Selection Screen
5. After you have selected the sensors to calibrate, press
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4.2.3 Selecting Sensors (cont.)
The Sensor Confirmation screen (shown in Figure 47 below) displays. This screen lists all the sensors selected on the Sensor Selection screen.
Sensor Confirmation
Reselect
I-01 Temp 01 I-02 Temp 02 Cancel I-03 Temp 03 I-04 Temp 04 Run Calibration
Run Verification
Main Menu
Figure 47: Sensor Confirmation Screen
6. If the sensors you selected are not the ones you want to calibrate, press
Reselect, and repeat
steps 5 and 6.
Now you are ready to calibrate the sensors.
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4.2.4 Calibrating Sensors

The Validator automatically calibrates sensors at the setpoints defined in your setup. Before starting calibration, make sure you have a USB flash or floppy disk in the disk drive. If you are printing calibration data to an attached printer, make sure the printer is connected to the Validator and powered on.
In the following example, you perform a two-point calibration (low setpoint and high setpoint) and a one-point check (check setpoint).
To calibrate sensors:
1. From the Sensor Confirmation screen (shown in Figure 48 below), press Run Calibration.
Sensor Confirmation
Reselect
I-01 Temp 01 I-02 Temp 02 Cancel I-03 Temp 03 I-04 Temp 04 Run Calibration
Run Verification
Main Menu
Figure 48: Sensor Confirmation Screen
The Validator clears calibration offsets stored in the SIMs for the selected sensors, and establishes communications with the temperature reference and the IRTD. When this is accomplished, the
Sensor Calibration screen (Figure 4-11 on the next page) displays. The
sensor locations and IRTD title display in reverse video until they reach stability.
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4.2.4 Calibrating Sensors (cont.)
IMPORTANT: All calibration offsets will be 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.
Sensor Calibration
Automatic
Stabilizing Low Setpoint
IRTD 89.861C ------------
Setpt 90.00C Elapsed Time: 0000:00:00 LOC TEMP STABILITY
I-01 89.98C ------------ I-02 89.97C ------------ I-03 89.98C ------------ I-04 89.96C ------------ Criteria
STOP
Figure 49: Sensor Calibration Screen
Note: Calibration offsets for sensors at each setpoint are written to the SIM when the
calibration process is complete. If you stop calibration, calibration offsets already calculated are not written to the SIMs, and the calibration report file is deleted.
For example, if you have completed low setpoint calibration, and then stop the calibration process during high setpoint calibration, the sensors ar e marked UNCAL'D in the SIMs and the calibration report file is deleted.
Calculating Stability
The first step in the calibration process is to verify that the sensors and IRTD are stable. 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), you can enter the IR TD stability value manually in your setup.
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4.2.4 Calibrating Sensors (cont.)
The stability calculation begins once the temperature reference is within 5 degrees of the low setpoint. Stability is computed at the scan rate.
To achieve stability, the IRTD and all sensors must meet the stability criteria defined in the setup. The IRTD and sensors display in normal video when they reach stability. If any sensors fail to reach stability, the calibration process remains here. To end the calibration process, press STOP.
Note: You can display the temperature setpoints and the stability and deviation criteria
defined for this setup at any time by pressing Criteria on the Sensor Calibration screen, as shown in Figure 50 below. Press Sensor Cal to redisplay the sensor readings.
Sensor Calibration
Automatic
Stabilizing Low Setpoint
IRTD 89.861C ------------
Setpt 90.00C Elapsed Time: 0000:00:30 LOC TEMP STABILITY
I-01 89.94C 0.02C I-02 89.99C 0.03C I-03 89.93C 0.03C I-04 89.92C 0.01C Criteria
STOP
Figure 50: Sensor Calibration Screen
Calculating Deviation of Uncalibrated Sensors
When the IRTD and all sensors reach stability, the Validator calculates uncalibrated deviation by comparing each sensor to the IRTD, and then logs the stability and uncalibrated deviation data to the calibration report file. The Validator marks any sensor outside the deviation criteria as failed. When uncalibrated deviation is complete, the Validator calibrates the sensors at the low setpoint.
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4.2.4 Calibrating Sensors (cont.)
Calculating Deviation of Calibrated Sensors
The Validator then calculates calibrated deviation. The corrected results for each sensor are compared to the IRTD, and logged and displayed every 30 seconds for the time period specified in the setup. Sensors that fail the calibrated deviation evaluation are displayed in reverse video and marked as failed in the calibration report file.
Data Logging Complete at Setpoint
When the Validator finishes logging the corrected results at the low setpoint, it automatically sets the Kaye temperature reference to the high setpoint and repeats the calibration process.
When the calibration process is complete for the high setpoint, the Validator automatically sets the Kaye temperature reference to the check setpoint. The only difference between low and high setpoint calibration and the check setpoint is that calibration offsets are not changed during check setpoint.
Calibration Complete
When calibration is complete, the System Message screen in Figure 51 below displays.
System Message MESSAGE TIME: 13-Apr-2005 Tues 10:49:51 MESSAGE LEVEL: Warning Continue MESSAGE DESCRIPTION: Floppy Disk Recording Complete
Figure 51: System Message Screen
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Calibration Complete (cont.)
IMPORTANT: Do not remove the disk until you acknowledge that the disk write is complete by
pressing Continue. If you remove the disk before the disk drive light goes out, you may lose data.
2. Press Continue and then remove the disk from the drive. The USB flash or floppy disk contains the calibration report file. Now that calibration is
complete, you can take the disk to your PC to generate a Calibration Report. See the Validator
online Help for information on generating a Calibration Report.

4.2.5 Rewrite Report to Disk

You can write an additional copy of the calibration report file to a USB flash or floppy disk using the Rewrite report to disk option.To rewrite the calibration report file to a disk:
1. Insert a USB flash or floppy disk into the appropriate Validator drive.
2. Press the blue security key. Enter your user ID and password on the System Login screen.
The Password Operations screen, shown in Figure 52 below and Figure 53 on the next page, displays.
Password Operations
Load Setup
Calibrate Sensors
Start Qualification
Select USB Disk Storage
Rewrite Report to Floppy
Main Menu
Figure 52: Password Operations
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4.2.5 Rewrite Report to Disk (cont.)
Password Operations
Figure 53: Password Operations
3. Press Rewrite Report to Disk
Chapter 4. Calibrating Sensors
Load Setup
Calibrate Sensors
Start Qualification
Select Floppy Disk Storage
Rewrite Report to USB Disk
Main Menu
The Validator copies the calibration report file to the disk. While the file is being saved, the green indicator light on the drive is lit. After the calibration report file is saved, the System
Message screen displays with a verification message, as shown in Figure 54 on the next page.
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4.2.5 Rewrite Report to Disk (cont.)
System Message
MESSAGE TIME: 13-Apr-2005 Tues 10:49:51
Floppy Disk Recording Complete
Verification Status: PASSED
Figure 54: Message Screen with Verification Status
Continue
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