MadgeTech HiTemp140-M12 User Manual
Medical and Pharmaceutical
Data Logging Solutions
Sterilization & Facilities Monitoring
Simplifying How the World Measures & Records Data
MadgeTech, Inc. is a global company, based in New England
and founded on old-fashioned principles, customer
service, quality, and trust. MadgeTech’s President, Norman
Carlson, started the company in 1996 and charted the
growth of the product lines and services while maintaining
those solid core principles.
Our Can Do team of engineers and technical sta
consistently incorporate new and innovative ideas into
our data loggers. In short, we push the envelope, raising
the bar in innovation and quality. Our competitors have
praised us by adopting many of our ideas as their own.
Over time, MadgeTech has become the industry standard
in the data logger market.
MadgeTech continuously develops new, cutting-edge
products, creating solutions for our customers around
the world in industries across the board. Our growing
network of distributors has expanded our presence to
Norman E. Carlson,
markets far beyond our home-headquarters in New
Hampshire, our products are now sold in over 100
countries around the world.
Our employees are committed to quality and customer
satisfaction. Behind the full range of MadgeTech’s products
and services is the cumulative expertise of experienced
engineers, manufacturing and electronic professionals
and technicians. Our knowledgeable sales team can oer
technical advice to assist in selecting the right product for
each application, as well as providing aer-sales support.
MadgeTech is dedicated to providing customers with
reliable, aordable products, hassle-free ordering, and
excellent service, saving customers time and money.
It is our goal to earn your trust in meeting your needs
and providing innovative solutions. The products and
services that bear the MadgeTech name come with quality
assurance and the best support in the industry today.
Founder & President
Data Logging Solutions
Steam Sterilization
Lyophilization
Dry Heat Sterilization &
Depyrogenation
Vaccine Temperature Monitoring
Ethylene Oxide Sterilization
Dry Ice Shipping
Cold Chain
Real Time Continuous
Environmental Monitoring
Service & Calibration
Steam Sterilization
MadgeTech has designed a series of data loggers specifically for validating temperature and pressure within
autoclaves. These rugged, stand-alone, fully-submersible devices can be placed directly inside the autoclave with
the product(s), providing an overall temperature and pressure profile to validate the entire sterilization cycle.
HiTemp140
Data Logger for High Temperatures
The HiTemp140 and HiTemp140-PT series data loggers are MadgeTech’s solution for precise high temperature monitoring. These data
loggers can indefinitely withstand temperatures of up to 140 °C (284 °F) and have an accuracy of ±0.1 °C. The HiTemp140 features a rigid
external RTD probe capable of measuring extended temperatures, up to 260 °C (500 °F). Varied probe lengths are available up to 7 inches.
The HiTemp140-PT features a 24 inch flexible steel RTD probe capable of measuring extended temperatures, up to 350 °C (662 °F).
The HiTemp140X2 series of dual probe high temperature data loggers oer extreme flexibility for high temperature monitoring
applications. This product is ideal for applications such as autoclave validation, sterilization processes and much more.
The HiTemp140-FR is a high temperature data logger with an ultra-fast response time, to record temperature during rapidly changing
thermal processes. This high temperature data logger is capable of recording as fast as 4 Hz.
The HiTemp140-FP probe design is narrow and lightweight making it ideal for placement within small vials, test tubes and other small
diameter or delicate applications. The flexible lightweight probe minimizes the risks of breakage (both vial and probe) and makes
placement of the probe is easy to manipulate.
The HiTemp140-M12 is a high temperature data logger designed with a built in M12 probe connecter. This logger is compatible with
dozens of M12 RTD probes and capable of measuring up to 850 °C (probe dependent).
Applications
• Steam sterilization cycle validation
• Autoclave chamber mapping
• Blood plasma sample monitoring
• Refrigerator/freezer monitoring &
mapping
• Continuous oven monitoring
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HiTemp140X2
HiTemp140-PT-1
HiTemp140-1
HiTemp140-M12
HiTemp140-FR
HiTemp140-FP
PRTemp140
High Temperature and Pressure Data Logger
The PRTemp140 is a data logger designed to validate if appropriate temperature and
pressure levels have been achieved during the steam sterilization cycle. It is built with
a precision stainless steel pressure gauge. The data logger has an accuracy of ±0.1
°C and ±0.03 Bar (±0.435 PSI), which can be achieved over a wide temperature range,
from +20 °C to +140 °C (+68 °F to +284 °F). The PRTemp140 is available in either a Flush
Top or NPT Pressure Port Top design, with an optional female luer fitting accessory.
NPT Pressure Port Top Luer FittingFlush Top
AVS
Autoclave Validation Data Logging System
MadgeTech oers the AVS Autoclave Validation System to satisfy demanding autoclave needs. This system comes with five HiTemp140,
High Temperature Data Loggers and one PRTemp140 Temperature and Pressure Data Logger, all loggers with NIST certified calibration.
The IFC406 Multiplexer Interface and one MadgeTech Secure Soware License with IQ/OQ/PQ validation workbook are also included
with this system. The AVS comes with all components securely packaged in a sleek and protective aluminum briefcase, ideal for storage
or transporting the system to multiple facilities or locations.
The AVS kit can be custom configured with any combination of HiTemp140 data loggers oering a wide variety of probe lengths to
choose from.
The AVS kit includes (Standard Package):
• (5) HiTemp140 High Temperature Data
Loggers with 1 inch probe, all with NIST
Calibration Certificates
• (1) PRTemp140 High Temperature and
Pressure Data Logger with an NPT port,
with NIST Calibration Certificate
• IFC406 Multiplexer interface
• MadgeTech Secure Data Logger Soware,
with IQ/OQ/PQ validation protocols and
workbook
• Aluminum Storage Briefcase
Order today at www.madgetech.com
|
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Dry Heat Sterilization, Depyrogenation
& Extreme Temperature Validation
For applications that require extended exposure to high heat, MadgeTech has developed a line of thermal enclosures for use with the
HiTemp140 series data loggers. These thermal shields and barriers expand the capabilities of the HiTemp140 series, making an ideal
solution for monitoring the extreme temperatures and exposure time required for eective Depyrogenation or Dry Heat Sterilization.
ThermoVault140-DHS
Dry Heat Sterilization Data Logging System
The ThermoVault140-DHS is a Dry Heat Sterilization Data Logging System, designed to be used in environments up to 400 °C for dry heat
applications. This system is specifically designed for use in the extreme temperatures required to adequately diminish pyrogens for the
eective sterilization of goods. The ThermoVault140-DHS features the HiTemp140-M12 data logger, equipped with a high temperature
detachable RTD probe and the ThermoVault140 stainless steel thermal barrier.
The ThermoVault140-DHS System includes:
• HiTemp140-M12 High Temperature Data Logger
• 36 inch Glass Braided RTD probe
with a ceramic tip
• ThermoVault140 Thermal Barrier
Time vs Temperature Chart
Expos ure Time in Air (minutes)Temperature
Ambient
-40 °C to +140 °C
150 °C
200 °C
250 °C
300 °C
350 °C
400 °C
*Please consult the measurement range of your data logger for
temperatures over 250 °C. (The thermal barrier extends the operating temperature of the data logger up to, but not exceeding the
measurement range)
ThermoVault140-DHS
Indefinitely
525
285
205
165*
140*
50*
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HiTemp140-M12
High Temperature Data Logger with an M12 Probe Connector
The HiTemp140-M12 is a high temperature data logger featuring and M12 probe connector.
Compatible with a wide variety of M12 RTD probe styles, this logger is capable of measuring up to
850 °C. (probe dependant)
All MadgeTech HiTemp140 series of data loggers are designed out of food grade stainless steel
and can be placed in environments as high as 140 °C (284 ° F).
The device records and stores up to 43,690 time stamped readings and is equipped with non-
volatile solid state memory which retains data even if the battery becomes discharged.
Time vs Temperature Chart
Expo sure Time in Air (minutes)Temperature
Ambient
-40 °C to +140 °C
150 °C
200 °C
250 °C
300 °C
350 °C
*Please consult the measurement range of your data logger
for temperatures over 250 °C. (The thermal barrier extends
the operating temperature of the data logger up to, but not
exceeding the measurement range)
Thermal Shield
Indefinitely
88
45
32
n/a
n/a
Thermal Shield
For Extended High Temperature Monitoring
For applications above 140 °C, a thermal shield is available for most models of the HiTemp140 and HiTemp140-PT series data loggers.
The thermal shield extends the operating temperature of the data logger, allowing it to be exposed to higher temperatures for a longer
amount of time. Flush and vented models are available to help provide probe protection.
Thermal Shields shown with HiTemp140 series data loggers.
Order today at www.madgetech.com
|
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Ethylene Oxide Sterilization (EtO/EO)
In accordance with ANSI/AAMI/ISO 11135, it is required for temperature and humidity levels be monitored during
an EtO/EO sterilization process. MadgeTech data loggers can be used to validate these parameters to ensure an
environment in which suicient sterility levels are achieved.
MadgeTech has developed data loggers designed specifically to validate temperature and humidity requirements for EtO sterilization
cycles. The Temp1000IS data logger measures temperature and the RHTemp1000IS measures both temperature and humidity.
Both devices are designed to withstand harsh environments and record data at user selected time intervals, providing a complete
temperature and humidity profile of each EtO cycle. The stand alone operation and compact size of these data loggers allows them to
fit easily into the sterilization chamber with the product load.
As federal regulations mandate that facilities produce records for each EtO sterilization cycle, all recorded readings are automatically
saved upon download and can then be included with validation documents and reports to verify a successful sterilization cycle. The
MadgeTech 1000IS Series has become the data logger of choice for the EtO sterilization industry.
The Temp1000IS and RHTemp1000IS are designed to be placed direc tly inside the sterilization chamber and meet the required regulation
equipment standards. These devices have been certified by FM Approvals as intrinsically safe for Class I, Division 1, groups A, B, C, D, and
non-incendive for Class I, Division 2, groups A, B, C, D, hazardous environments.
RHTemp1000IS
Intrinsically Safe Humidity & Temperature Data Logger
The new RHTemp1000IS is MadgeTech’s most robust temperature and humidity data logging solution.
FM Approved to be Intrinsically Safe for Class 1, Division 1, groups A, B, C, and D and non-incendive
for Class 1, Division 2, groups A, B, C, and D, the RHTemp1000IS is certified as safe for use in many
hazardous locations where explosive gas atmospheres are present.
The RHTemp1000IS features a cutting-edge thermoset-polymer capacitive sensor, that provides
the longest operating life in an ethylene oxide-based (EtO) sterilization process. With the ability to
maintain resistance against various chemical liquids and vapors like isopropyl, benzene, toluene,
formaldehydes, oils and common cleaning agents, this sensor is ideal for EtO processes, as well as
continuous, long term use.
The RHTemp1000IS enclosure is made of 316 Stainless Steel. It’s small size and sleek design allows it
to be placed precisely in critical locations for temperature and humidity mapping.
Its ultra-fast communication speed allows for programming and data download in just seconds. Using
the IFC400 docking station, communications are established automatically through metal contacts
and up to 18 units can be programmed simultaneously using the IFC406 multiplexer.
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