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Kaye Validator: Sensing & Inspection Technologies

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0% found this document useful (0 votes)
241 views16 pages

Kaye Validator: Sensing & Inspection Technologies

a
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

GE

Sensing & Inspection Technologies

Kaye Validator

Guide to thermal validation


and temperature calibration

g 1
The Kaye Validator is a stand-alone thermal validation
system that simplifies the entire validation process by
reducing set-up time, minimizing sensor handling, and
presenting critical study data in easily customized report
formats. The Validator software now incorporates the
latest technology for faster data collection, improved data
management and more flexible reporting and analysis to
save you significant time.

This advanced system is specifically designed to conform


with 21 CFR Part 11 and meet international and European
norms for validation of pharmaceutical, biotechnology and
medical device manufacturing plants.

The Validator also provides precise temperature and


pressure measurement capabilities for saturated steam
environments.

Kaye Validator
Benchmark thermal validation system

Soft keys and


menus provide
IDs and passwords versatile operation.
are required to start
Displays online data
and stop a process,
and calculations, View data, calculations
check configuration
set-up parameters and messages with
or calibrate sensors.
and sensor offsets. scroll keys.

Connects to your PC

Three connections (RJ11) for a Kaye


Temperature Reference and up to two traceable
Temperature Standards

Connection for a parallel printer for


online printout of raw data

USB drive allows data storage and setup transfer

Contact output for signalling a PLC or other device

USB com port

Universal power (90-240 VAC, 50/60Hz)

2
Regulatory Compliance Electronic Records, Secure Audit Trail,
and Electronic Signature
The Kaye Validator is specifically designed to enable
compliance with FDA 21 CFR Part 11. All recorded data,
including calibration offsets, set-up parameters, and
administrative tasks are saved in secure, encrypted,
tamper-proof electronic records in a format accessible only
through the system software.

In addition to passwords now being centrally managed in a


network-installed version, users can explicitly set
permissions for each user.
With the network capability, audit trails have been
improved to allow centralized management, searching and
printing of department-wide audit trails from any
connected PC. The sort and find utilities allow system
administrators to perform thorough audits of their validator
users; for example, a list of all failed login attempts within a
specified time period across all networked computers.
There is notification to the user and logged entries in the
audit trail if files are tampered with or deleted from within
Windows Explorer.

User Account Creation

Three levels of authorization protect access to the


system assigning users, making changes to tests, or
running tests.

Login Window

Each person has a unique signature, as defined by a user


ID and password. This signature is required for any action
that can affect dataat the Validator or PCwhether you
are in Set-up, calibration or qualification mode.

3
A secure path for wiring sensors is provided for strain relief
Real-Time Process Monitoring and organization of your probes. The wired SIM shows 10
thermocouples and one pressure sensor (a shunt resistor is
Monitor and Control Qualification Studies with used by the Kaye Validator for converting current to
the Instrument or the PC voltage). You can order SIMs pre-wired with thermocouple
The Kaye Validator can show you the entire qualification probes, labeled numerically.
process in real timewhether you run a study using only
the Validator or in conjunction with a PC.

As a stand-alone instrument, the Validator provides


operator flexibility with a menu-driven display and soft
keys. Scrolling through data, calculations, and messages,
you can view real time or historical data. File settings such
as sensor information, calculation definitions, instrument
and SIM status, and summary header information are
The wired SIM is ready to use for either a new calibration or,
available as well.
if calibrated, for use in a qualification run. Plug-in SIMs let
Define Conditions for Automatic Start and Stop you handle up to 12 sensors at one time. A shock-resistant
Now you have more control over starting and stopping enclosure provides a uniform environment for your
your test. You can start qualification and exposure thermocouple junctions. Labels on top and sides let you
automatically based on any calculation, input, or time of write information such as calibration date or serial number
day. You can stop the process using the same criteria plus of the Kaye Validator. Built-in memory retains calibration
elapsed time. Start and stop can also be controlled offsets. A 4/20 mA specific SIM is available for use with
manually. current loop transducers such as pressure, moisture,
humidity, or CO2.
Faster Data Storage Rate and More Choices
You can collect data as fast as one input per second, or at
intervals of 2, 3, 5, 10, 20, 30, and 60 seconds or minutes, or Network Support
1, 3, 6, or 12 hours. You can also set the rate for online
printing with a printer connected to the Kaye Validator. The software provides features to satisfy the needs of
growing Validation departments in managing their Kaye
PlugIn Modules Protect validation systems.
All critical data to a validation, including passwords, audit
Thermocouples and Simplify trails, qualification, and calibration records can be
automatically stored at a network location defined at
Study Set-Up software installation time by a system administrator.

At software installation, the system administrators can


A Better Way to Handle Sensors choose to enable network install and can predefine
Three Sensor Input Modules (SIMs), accommodating up to 12 settings for all their users, such as password database
sensors each, including 4/20 mA inputs, can plug into the location, data file locations, and other site options. The user
Kaye Validator. Each SIM accepts any combination of will then install the software from the network and it will be
thermocouple, voltage or current inputs such as humidity automatically configured as per the system administrators
and pressure transducers. There are no fixed sensor selections.
locationswire any sensor to any terminal. SIMs have
built-in memory that store calibration offsets. This means Synchronization is also supported. The user can run the
you can store calibrated sensors that are ready to use when validation system disconnected from the network and at
you need them. the next opportunity the software will automatically update
the network files and database with any changes from the
disconnected session.
The SIM contains connections for wiring sensors and a
precision reference RTD to measure thermocouple junctions.
During sensor calibration, a memory circuit stores the
correction value for each sensor. This feature can save you
time preparing for the next study. It also ensures that
instrument accuracy is maintained.

System Administration Site Options

Security policies and site options can now be selected and


forced on global network basis.

4
Test Set-Up
Study Set-Up is Intuitive and Versatile
The Kaye Validator was designed to help you get the
data you want from a validation study quickly and easily.
It starts with the Validator software that allows you to
set up and customize sensor calibration, qualification, and
report generation.

The software lets you separate inputs by group with unique


calculations and reports. The use of groups lets you organize
how information is displayed and reported. For example, you
can generate separate reports for distribution and
penetration sensors or qualify multiple chambers at the
same time.
1
Another view lets you easily define group test parameters 2
including sensor assignments, calculations, comments and 3
the event to be monitored.

1 2 3

Statistical Calculations screen Lethality Calculations screen Interval Calculation screen

Clicking on Statistical Calculations Set up or modify lethality calculations Within each group, the Kaye Validator
allows you to select only those you by defining base temperature, Z, and can report intervals for each sensor
want to view during the study. Add D values. Select conditions when you and the group. You establish the
more calculations when youre ready want to calculate lethality. conditions upon which the group
to generate the final report. intervals start and end.

You can customize reports right down to header


information and user comments for each group. In
Humidity

Humidity

Humidity
Inctmp 01
Inctmp 02
Inctmp 03
Inctmp 04
Inctmp 05

Inctmp 06
Inctmp 07
Inctmp 08
Inctmp 09
Inctmp 10

Inctmp 11
Inctmp 12
Inctmp 13
Inctmp 14
Inctmp 15

addition, you can enter summary comments that relate to


SIM 1

SIM 2

the entire study. 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6

The Kaye Validator software provides flexibility in other


CALCULATIONS CALCULATIONS CALCULATIONS
ways. You can define sensors individuallycreating your FOR INCUBATOR 1 FOR INCUBATOR 2 FOR INCUBATOR 3

own labels and detailed descriptions, or applying an group max group max group max
group min group min group min
individual sensor definition to a range of sensors. interval max interval max interval max
interval min interval min interval min
humidity humidity humidity
Featuring interval calculations and monitored events, the
Kaye Validator provides more information about your
REPORT REPORT REPORT
study. You can calculate maximum, minimum and average FOR INCUBATOR 1 FOR INCUBATOR 2 FOR INCUBATOR 3

for each sensor during the interval.

Users can add unlimited cycles, separating qualification


data into separate process phases, and up to 25 groups,
with their own calculations and graphs during reporting,
often eliminating the need for post-processing in Excel.
5
Post Qualification Reporting
Validator users can for the first time gain access to the
flexible and user-friendly Kaye ValProbe reporting system.
In addition to preserving the existing Validator group and
event structure, users can now add unlimited cycles and up
to 25 groups during the reporting phase.

The set-up screen shows all defined sensors in the set-up.


Clicking the Groups tab lets you select the sensors you want
to include in a particular group.

Cycles are like eventsthe qualification data is separated


into distinct phases and summary reports can be
generated for each cycle.

You can define each sensor individually, including a


detailed description, or a range of sensors at the same
time.

Reports
The Kaye reporting Software includes an intuitive, yet
powerful reporting utility for generating Set-Up, Calibration,
Qualification and Calibration Verification reports to
document validation study results. Reports are generated
from secure data files that can only be read by the system Cycle Headers
software. Upon study completion, process cycles to be
analyzed are defined using the intuitive system graphic The user can generate regulatory-accepted reports
feature. including detailed and summary reports by group and cycle
(interval data). Graph reports have been improved, allowing
Features: more inputs and better access to graph properties such as
colors and data limit lines.
Load set-ups, store study data and upgrade firmware via
USB or Floppy
Report templates are automatically created, allowing the
Common reporting software for Validator, ValProbe
user to reprint an exact copy of the report at a later date,
and RF ValProbe gives added flexibility and convenience
or save to a template for use in subsequent validation
in merging data files from multible Kaye devices.
studiesa significant time savings for system operators.
Powerful graphing tool during reporting with report
wizard shows all sensors and samples through a
complete study.
Report wizard allows to selsct lethality calculation also
during reporting. Lethality parameters can be changed.

6
Merged Reporting
Users have the ability to combine or merge reports from
several Validators or ValProbes, providing the validations
were run concurrently. A typical example would be during a
freeze dryer validation where two Validators are needed, or
if a ValProbe pressure logger is used alongside Validator
temperatures.

For qualification reporting, the software provides more Print Options


capability to analyze your study. Using various
selectionscalculations, intervals, events, conditions,
elapsed time, specific groupsyou can answer questions
about your study that could only be done previously in an
exported spreadsheet application.

If you need to perform additional analysis, simply open your


validation file in another application. The original data is
not modified.

Footer Options and User Comments

SOPs require a sign off on validation reports. But SOPs vary


on the number of signatures and the pages. The Kaye
Validator lets you make these selections, as well as where
you want user-entered notes. With the report generator
you can print the information and data from an entire
study, or a smaller report from one of your defined groups.

Validator - Qualification Summary Report Printed on 11-Jul-2008 14:51:56 by GE Supervisor


Study Name: Let calcs Min>120C 2sec storage SOP/Protocol #:
Letalit tA

Temperature Data(C)
Logger S/N Heating Up Exposure Cooling Down Totals
Cycle Cycle Cycle Total
Min Max Avg ALeth Min Max Avg ALeth Min Max Avg ALeth ALeth
101A-T01 (C) 51,13 119,95 91,66 0,03 120,11 123,44 122,91 8,91 68,27 120,83 96,92 0,06 9,00
102A-T02 (C) 51,06 120,03 91,78 0,05 120,18 123,41 122,89 8,86 67,79 120,75 96,56 0,06 8,97
103A-T03 (C) 51,70 120,35 92,43 0,11 120,50 123,47 122,97 9,00 66,85 120,38 95,70 0,03 9,14
104A-T04 (C) 51,28 120,01 91,91 0,05 120,16 123,29 122,78 8,63 67,60 120,49 96,27 0,03 8,71
105A-T05 (C) 50,95 119,99 91,54 0,03 120,15 123,50 122,98 9,04 68,52 120,98 97,13 0,09 9,16
106A-T06 (C) 51,46 120,40 92,40 0,11 120,55 123,53 123,03 9,14 66,97 120,51 95,78 0,03 9,28
107A-T07 (C) 51,26 120,10 91,94 0,05 120,25 123,42 122,91 8,90 67,72 120,63 96,41 0,06 9,01
108A-T08 (C) 51,71 120,55 92,64 0,14 120,63 123,58 123,08 9,25 66,77 120,34 95,52 0,02 9,41
109A-T09 (C) 51,10 120,09 91,76 0,05 120,25 123,52 123,00 9,10 68,15 120,87 96,82 0,08 9,23
110A-T10 (C) 51,76 120,53 92,63 0,14 120,65 123,58 123,08 9,23 66,65 120,35 95,51 0,03 9,40
111A-T11 (C) 51,66 120,37 92,35 0,11 120,51 123,49 122,98 9,03 67,25 120,33 95,88 0,03 9,17
112A-T12 (C) 52,04 120,70 92,96 0,17 120,26 123,54 123,03 9,11 66,06 119,95 94,85 0,00 9,28
201A-T13 (C) 51,18 119,95 91,72 0,03 120,10 123,31 122,80 8,67 67,99 120,55 96,53 0,03 8,73
202A-T14 (C) 51,87 120,62 93,05 0,17 120,46 123,48 122,97 9,00 65,60 120,15 94,72 0,00 9,17
203A-T15 (C) 51,94 120,41 92,71 0,11 120,32 123,38 122,88 8,83 66,34 120,01 95,09 0,00 8,94
204A-T16 (C) 51,33 120,13 92,09 0,05 120,28 123,34 122,84 8,75 67,29 120,49 96,03 0,03 8,83

Temperature Summary Data(C)


Heating Up Exposure Cooling Down Totals
Study Start
Cycle Start 10-Jul-2008 15:36:22 10-Jul-2008 15:43:48 10-Jul-2008 15:49:36 10-Jul-2008 15:36:22
Cycle Duration 0:07:26 0:05:48 0:03:24 Study End
Min of Min 50,95 S/N 105A-T05 120,10 S/N 201A-T13 65,60 S/N 202A-T14 10-Jul-2008 15:53:00
Time 10-Jul-2008 15:36:22 10-Jul-2008 15:43:48 10-Jul-2008 15:53:00 Duration 0:16:38
Max of Max 120,70 S/N 112A-T12 123,58 S/N 108A-T08 120,98 S/N 105A-T05 Min ALeth 8,71
Time 10-Jul-2008 15:43:46 10-Jul-2008 15:45:26 10-Jul-2008 15:49:36 S/N 104A-T04
Max Range 69,75 3,48 55,38 Max ALeth 9,41
Max Spread/Time 2,40 Time 15:37:38 0,98 Time 15:49:34 3,11 Time 15:52:06 S/N 108A-T08
Min ALeth 0,03 S/N 101A-T01 8,63 S/N 104A-T04 0,00 S/N 112A-T12 Study Min 50,95
Max ALeth 0,17 S/N 112A-T12 9,25 S/N 108A-T08 0,09 S/N 105A-T05 S/N 105A-T05
Avg of Avg 92,22 122,95 95,98 Study Max 123,58
Performed by:_____________________________________________ Date: ____________ S/N 108A-T08

Reviewed by:_____________________________________________ Date: ____________

Summary report
7
Graphing
A powerful graphing utility within the system software
greatly simplifies process analysis and reporting. Sliding
vertical axes enable the operator to flag and define
process transition points, eliminating unnecessary
reporting and streamlining the review process. The graph
utility features increased flexibility for graph customization,
including specifying X and Y axis ranges, background
colors, line styles and labeled limit lines.

Set the criteria for a sensor calibrationlow, high and check


point for the actual calibration and the points to verify
calibration after a study.

Kaye Validator powerful graphing utility

Sensor Calibration The PC shows the entire calibration process on one screen.
Data fields change color to show the progress of stability and
You save time and eliminate manual methods, of sensor deviation for each sensor. A status screen (above, right) lists
calibration, which results in better accuracy. By automating each step and indicates where the system is in the process.
sensor calibration, the system reduces training require-
ments for your department, and makes the operation
available to the non-metrologist.

Select only the sensors you want to calibrate. Defining a


calibration set lets you calibrate any number of sensors
among all those wired to the system.

8
Fully Automated Sensor Calibration
Sensor calibration is one of the most difficult and time
consuming tasks associated with validation. The SOPs
in most companies require sensor calibration before the
validation study and a check afterwards to ensure the
integrity and accuracy of collected data.

One Set-Up Screen to Automate Sensor Calibration


You define the set-point criteria of each sensor for
calibration. Calibration can be a three-point procedure,
including a two-point sensor correction and a third
checkpoint.

One screen lets you specify the required calibration points


(low, high, and checkpoint); select the stability criteria that View real time readings, their location and stability during
thermocouples need to meet before they are calibrated; stand-alone calibration. The display then changes the
and specify the deviation criteria to ensure that stability column to deviation and shows the user when
out-of-range sensors are not used. each sensor meets criteria.

You can control and monitor a calibration from the


Validator or the PC. For example, if an uncalibrated
thermocouple fails if the difference between the traceable
standard and the thermocouple is greater than 1.0C. A
tighter criteria of 0.5C is used for calculating the deviation
of calibrated sensors.

Checkpoint Calibration
Verifying sensor calibration, typically at the point of use,
ensures all temperature measurements are within the
deviation criteria.

Post Calibration Verification


After any number of qualification runs, the Kaye Validator
can verify that sensor readings have not changed from Use the display to view the results of a sensor calibration
their original calibration. You can define verification to including offsets stored in SIMs and read by the Kaye Validator.
be any combination of the three points used in calibration. Calibration verification using additional points can be
A software check that all sensors are reading within the automatically triggered from the PC software without
calibration criteria ensures that sensors have not been changing or downloading a new setup. The calibration
damaged during qualification and data is consistent. verification report will then combine the multiple
verifications into a single report.

9
High Accuracy Referencing Fast/Accurate References
One temperature reference covers the temperature range
for the high and low calibration point used for a typical
GEs temperature calibration equipment is designed validation study. Choose the model that best fits your need
specifically to maximize overall system accuracy. from the chart below.
Calibration equipment includes temperature references Temperature dry wells employ unique inserts that
with superior uniformity for sensors, traceable intelligent minimize cooling of the thermocouple tips due to stem
RTD standards, and validation software to communicate conduction. Without proper inserts, transfer uncertainty in
with the hardware. excess of 0.5C can occur with 22 gage, type T
thermocouples. GE units provide an uncertainty of 0.1C.
Intelligent RTD Standard
The IRTD Temperature Standard (IRTD-400) is a Calibrating over a more limited range will also increase
NIST-traceable instrument that is calibrated over the range accuracy. Since regulations require calibration for the
of -195 to 420C. It is accurate to 0.025C over the entire temperature range of a process, an autoclave, for example,
operating range. can be calibrated from 90 to 125C. This method reduces
the error from thermocouple characteristics to less than
The IRTD-400 is a completely self-contained measurement 0.05Ca two-fold improvement over a calibration at 0C
system, containing the electronics for calibration and and 125C.
temperature conversion.
The temperature bath, CTR-80, provides very fast
Communicating directly with the Validator software, the response (90 minutes from ambient to -80C) and quiet
IRTD-400 eliminates the potential for human error, assuring operation. Rugged casters allow this unit to be moved with
accurate and traceable measurements. little effort. A specially designed cover supports two IRTD
standards and all thermocouples from the Kaye Validator.

2 wells for Temperature Standards,


6.7 mm (0.265 in) 2 wells for Temperature Standards

Calibration Wells,
9 mm (0.354 in)
without inserts

CTR-80 temperature bath with 3 wells for 12


HTR-400 temperature LTR -25/140 thermocouples from each SIM. Adjustable slides
block with 10 wells temperature block cover the unused holes and clamp wires in place.
with 8 wells

Temperature Reference Selection


HTR 400 Dry Well LTR-140 Dry Well CTR-80 Bath
Range 50 to 400C -40 to 140C and -25 to 140C -80 to 100C and -40 to 150C
Uniformity 0.05C 0.05C 0.03C
Application Autoclaves, dry heat ovens, Freezers, cold rooms, Freezers, cold rooms,
sterilization tunnels incubators, autoclaves incubators, autoclave

10
Kaye Validator
Pressure Transducer
In order to meet the stringent requirements of EN554 and
ISO-17665, it is a requirement that saturated conditions
are also validated along with temperature.

An easy to use, accurate and reliable pressure transducer


is available for the Kaye Validator System.

Features
Designed for the harsh environment applications such as
steam sterilizers and SIP systems
High performance pressure transducer, specified at full
temperature range of autoclave
Can be directly connected to 1.5 in triclover flange
Full ISO-17025 traceable calibration over pressure and
temperature range
East of Use wires directly to Kaye Validator with no
additional wiring or power supplies required.

Specifications

Type
Absolute Pressure Transducer

Range
0 bar to 4 bar (59 psia) Absolute

Sensitivity
1V to 5V

Non-linearity & hysteresis


0.2% combined
Stainless Steel Feedthru
Temp. compensated range
110C 140C
Fitting
Feedthru Fitting allows up to 18 thermocouples of any
Accuracy
diameter to be introduced into pressure vessels such as
10mbar (0.147 psi) at 110C 140C
steam or gas sterilizers, dry heat ovens and lyophilizers.
Made of stainless steel with silicon rubber sealing gaskets,
Calibration these TV certified Feedthru is designed with no wire-
Pressure calibration performed at 23C and 121C damaging threads or sharp edges and is easily installed
using standard 1.5 in (38.1mm) tri-clamp and gasket
Software Support fittings
The Kaye Validator Report Wizard provides EN554,
HTM2010 and IS-17665 complaint reports.
The user can create:

Saturated Pressure and Temperature Graph Reports


utilizing temperature and pressure actual data along
side calculate saturated readings
Automatic equilibration pass/fail determination
Automatic Tb, Tb+3 limit determination based on
temperature versus saturate temperature, or pressure
versus saturated pressure

11
System Documentation The IQ/OQ Protocol includes the following:
Installation Qualification document
Quality Control Documents Operational Qualification document
GEs quality policy, the ISO 9001 implementation and Standard Operating Procedures document
certificate, and document control standard operating Set-up programs
procedures (SOPs)
Validation Reference
Development Procedures The Kaye Validator system is supported with
Design control and project management SOPs, and documentation that verifies a fully validated system,
functional specifications including software, hardware and firmware. The Validation
Reference Binder provides a comprehensive overview of
Quality Assurance Procedures the GE Quality Policy, description of ISO 9001
Test plan and test case procedures implementation and support procedures, and standards for
the development, testing, and maintenance of hardware
Release Documents and software. Quality Control documents, Development
Quality assurance certification and product release notices procedures, Quality Assurance procedures, Release
documents, and Quality Assurance test documentation are
Quality Assurance Test Documentation all included.
Quality assurance test plan and test cases The Validation Reference is a serialized document,
ensuring that registered users automatically receive
IQ/OQ Protocol notification and updates to keep documentation current.
The Installation Qualification/Operational Qualification The result is a summary of information you would obtain
Protocol defines a set of procedures to ensure that the by conducting an audit at GEs facilitycomplete, well
Kaye Validator system is properly installed and operated organized, neatly packaged, and immediately accessible.
according to GE recommendations, and is adequately
documented and controlled according to cGMP
requirements. The documents are provided in hard copy
and on CD, allowing users to modify the documentation to
suit specific organizational requirements.

12
System Specifications Voltage Input Accuracy 30 days: (0.003% of reading + 2 counts + 4
microvolts)
1 year: (0.006% of reading + 2 counts + 4
Total System Specifications microvolts)
When you use specifications to compare equipment, be Sensitivity 0.5 microvolts/count on most sensitive range
sure to establish an error budget that accounts for all Voltage Temp. Coef. (0.1 microvolts + 0.001% reading)/C
possible measurement uncertainty. Sensor calibration is an
Compensator Temp. Coef. 0.01C per C
integral part of validation, and total system accuracy
Input Terminal Temperature 0.1C
should include potential error from the recorder, as well as
Non-uniformity
the temperature reference and traceable standard.
Input Ranges -6 to 30mV, -60 to 300mV, -2 to 10V
Since all component errors are additive to the total system, Environmental Temperature: 0 to 50C (32 to 122F)
every potential error is significant. A summary of the error Relative humidity: 95% non-condensing
budget for a GE validation system after sensor calibration Power 90 to 250 VAC, 50/60 Hz
with type T thermocouples, used at steam and dry heat, is Fuse Rating 2A Slo Blo
listed below. These specifications are guaranteed under
Size 191 H x 343 W x 343 mm D (404 mm with SIM)
worst case conditions. Under typical operating conditions, 7.5 in H x 13.5 in W x 13.5 in D (15.9 in with SIM)
you can expect significantly better accuracy.
Weight 9 kg (20 lbs)

Kaye Validator (resolution and short term stability) 0.017C k=1


Temperature Measurement Standard (IRTD)
IRTD Temperature Standard 0.01C k=1 Specifications
IRTD-400
Temperature Reference 0.051C k=1
Temperature Range -195 to 420C
Total System Uncertainty 0.078C k=1
Accuracy Over Range 0.025C
1

Resolution 0.001C
Sensor Element 100 platinum sensor
Sheath Material Inconel 600
Immersion Depth 102 mm (4 in)
Calibration2 Traceable to NIST; recommended calibration period
is one year.
Power to Probe Unregulated DC, 10 to 25V; first probe: 850 mW at
15V; each additional probe: 550 mW
Power Supply3 Adapter: 110 VAC US-style, or 220 VAC
VDE-approved
Measurement Rate 30 readings per second
Software IRTDWin software for offline use to compare IRTD
probes
Environmental Ambient temperature range: 0 to 60C (32 to 140F);
humidity 0 to 95% non-condensing
Kaye Validator Specifications
Dimensions Overall length: 603 mm (23.75 in); grip: 89 mm x 32 mm
Analog Input Up to 36
(3.5 in x 1.25 in) sensor sheath: 457 mm x 6.35 mm
Thermocouples Type T, J, K: 0.1C or F resolution; T limited (18 in x 0.25 in)
range 0.01C resolution
Scanning Speed 8 or 12 inputs/sec at 50/60 Hz Notes: 1. Accurate for one year, from 0 to 60C ambient. Includes calibration
certificate with traceability to NIST.
Internal Memory 2 Mb for data collection
2. GE provides a recertification service for calibrating the Temperature
Internal Battery NiCad; 30 minutes of battery backup Standard.
Input Impedance 10K. Source greater than 10K produces 3. Power supply is not required for use with the Kaye Validator
system.
open circuit indication
Common Mode 160 db (8 inputs/sec) @ line frequency
Rejection 145 db (12 inputs/sec) @ line frequency
140 db @ DC
Max. Common 100V pk ch-to-ch
Mode Voltage 350V pk ch-to ch to frame ground
Normal Mode 82 db @ 60 Hz (8 inputs/sec)
Rejection 69 db @ 60 Hz (12 inputs/sec)
Voltage Input 0 to 10 VDC
Resolution 1:72,000

13
Cryo Temperature Bath Specifications
CTR -40 CTR -80
Temperature Range -40 to 150C Temperature Range -80 to 100C
Temperature Stability 0.005C to -40C (ethanol) Temperature Stability 0.03C
0.005C to 25C (eau) Temperature Uniformity 0.03C
0.007C to 150C (huile 5012)
Bath Volume 1 US gallon ethanol or Halocarbon 0.8 oil
Temperature Uniformity 0.01C (-90 to 70C) (order ethanol locally,
Bath Volume 9 liters order oil from GE)
Immersion Depth 234 mm (9.25 in) Immersion Depth 203 mm (8 in) max.
Access Area 94 mm x 172 mm (3.7 in x 6.8 in) Access Area 108 mm2 (18 sq in), cover removed
Depth 234 mm (9.25 in) Depth 457 mm (18 in)
Heater Power 700 watts Heater Power 500 watts
Cooling Rate 25 to -40C 110 minutes, typical with ethanol Cooling Rate 25 to -80C 90 minutes, typical with ethanol
Resolution 0.01C Resolution 0.01C
Setting Repeatability 0.01C Setting Repeatability 0.01C
Temperature Controller 24-bit digital Temperature Controller 24-bit digital
Display LED w/0.01 (C or F) display resolution Display LED w/0.01 (C or F) display resolution
Communications RS-232 Ramp Rate Control 0.1C per minute to capacity of bath
Safety Over temperature limits, user settable; Communications RS-232 (for use with thermal validation)
low voltage cutout; automatic Safety Over temperature limits, user settable;
refrigeration turn-off at 55C low voltage cutout; automatic
Refrigeration R-507 single stage refrigeration turn-off at 30C
Drain Yes Refrigeration Cascade using two-1/4 HP compressors;
refrigerant first stage: R507;
Controls Power switch; setpoint and function buttons
second stage: R508B
Power 115VAC 60Hz, 16A or 230VAC 50Hz,
Drain Yes
8A 1700 watts
Controls Power switch; setpoint and function buttons
Dimensions Off Cart: 584 mm H x 305 mm W x 622 mm D
(23 in x 12 in x 24.5 in) Power 115 VAC 60Hz, 16 A; or 230 VAC 50Hz, 8 A
On Cart: 819 mm H x 305 mm W x 622 mm D Dimensions 762 mm H x 305 mm W x 610 mm D
(32.25 in x 12 in x 24.5 in) (30 in x 12 in x 24 in)
Weight 32 kg (78 lbs) Weight 57 kg (125 lbs) on casters
Certificate Conformance certificate provided with unit. Certificate Conformance certificate provided with unit

14
HTR 400 LTR 25/140 LTR 40/140
Temperature Range 25C above ambient to 400C 25C to 140C 40C to 140C
Ambient Operating Range 5C to 50C 5C to 50C 5C to 50C
Set-Point Accuracy 0.2C to 300C 0.2C 0.2C
0.3C to 400C
Temperature Stability 0.02C to 300C 0.02C 0.02C
0.05C to 400C
Transfer Calibration Accuracy* 50C to 150C: 0.1C 25C to 80C: 0.1C 40C to 25C: 0.15C
IRTD Standard to Thermocouples 50C to 250C: 0.2C 80C to 130C: 0.15C 25C to 80C: 0.1C
250C to 350C: 0.3C 130C to 140C: 0.18C 80C to 130C: 0.15C
350C to 400C: 0.4C 130C to 140C: 0.18C
Typical Heat-Up Time Ambient to 90C: 5 minutes Ambient to 80C: 6 minutes Ambient to 80C: 6 minutes
90C to 125C: 3 minutes Ambient to 140C: 14 minutes Ambient to 140C: 14 minutes
350C: 25 minutes
Well Configuration Reference wells (2): 6.7 mm diameter x Reference wells (2): 6.7 mm diameter x Reference wells (2): 6.7 mm diameter x
x 127 mm deep 155 mm deep 155 mm deep
Calibration wells (8): 9 mm diameter x Calibration wells (6): 9 mm diameter x Calibration wells (6): 9 mm diameter x
155 mm) deep 155 mm) deep 155 mm) deep
Display LED w/0.01C resolution LED w/0.01C resolution LED w/0.01C resolution
Computer Interface RS232 RS232 RS232
Dimensions 343 mm x 198 mmx 317.5 mm 343 mm x 198 mmx 317.5 mm 343 mm x 198 mmx 317.5 mm
Weight 8.2 kg 13.6 kg 13.6 kg
Power 115 VAC 60 Hz, 6 A or 230 VAC 115 VAC 60 Hz, 3 A or 230 VAC 115 VAC 60 Hz, 3 Aor 230 VAC
50 Hz, 3 A 700 watts 50 Hz, 1.5 A 350 watts 50 Hz, 1.5 A 350 watts
Fault Protection Sensor burnout protection, over Sensor burnout protection, over Sensor burnout protection, over
temperature thermal cutout, temperature thermal cutout temperature thermal cutout
electrical fuse electrical fuse electrical fuse
* Transfer calibration accuracy is the difference between the thermocouple tip and the sensor of the IRTD temperature standard. This accuracy includes well to well
uniformity.

15
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BR-146A

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