MadgeTech AVS140-1 Specification sheet

AVS140-1
Autoclave Validation Data Logging System
Product User Guide
To view the full MadgeTech product line, visit our website at www.madgetech.com.

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Autoclave Validation Data Logging System ..........3
Hardware ............................................................ 4-5
Software .............................................................. 6-7
IQ/OQ/PQ Validation Protocol ............................. 8
System Installation ................................................ 9
Maintenance ....................................................10-11
Table of Contents
Autoclave Validation System
Data Logger Interface & USB Cable Certificate of Calibration
IQ/OQ/PQ
Validation Protocol
Software
USB Cable Calibration CertificatesIFC400
HiTemp140 MadgeTech 4 Secure Software
Data Logger
IQ/OQ/PQ Validation
Protocol Workbook
The AVS140-1 is a complete system used to perform autoclave validations. The AVS140-1 consists of a
high temperature data logger, an IFC400 Interface and the MadgeTech 4 Secure Software providing tools
to users to assist with FDA 21 CFR Part 11 compliance.

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BATTERY WARNING: FIRE, EXPLOSION, AND SEVERE BURN HAZARD. DO NOT SHORT CIRCUIT, CHARGE, FORCE OVER DISCHARGE,
CRUSH, PENETRATE, OR INCINERATE. BATTERY MAY LEAK OR EXPLODE IF HEATED ABOVE 150 °C (302 °F).
The HiTemp140 data logger is MadgeTech’s solution for high precision, rugged
temperature monitoring. It can withstand temperatures from -40 °C to 140 °C and has
an accuracy of ±0.1 °C.
The HiTemp140 can store up to 32,700 readings, and features a rigid external probe
capable of measuring extended temperatures, up to 260 °C (500 °F). Custom probe
lengths up to 7 inches are available. Also available, is the HiTemp140-PT that features a
24 inch flexible stainless steel probe for measuring extended temperatures up to 350 °C
(662 °F). The probe is durable and can be spiraled, bent or angled in any direction,
making it easy to log temperatures within bottles, vials or other hard to reach places.
HiTemp140 Product Overview
HiTemp140 Specifications
Hardware
Temperature Sensor: 100 Ω Platinum RTD
Probe Measurement
Range:
HiTemp140:
-200 °C to +260 °C (-328 °F to +500 °F)
HiTemp140-PT:
-200 °C to +350 °C (-328 °F to + 662 °F)
Temperature Resolution: 0.01 °C (0.02 °F)
Calibrated Accuracy:
±0.1 °C/±0.18 °F
(20 °C to +140 °C/68 °F to +284 °F)
±0.3 °C/±0.54 °F
(-20 °C to +19.99 °C/-4 °F to +67.98 °F)
±0.4 °C/±0.72 °F
(-40 °C to -20.01 °C/-40 °F to -4.02 °F)
Reading Rate: 1 second up to once every 24 hours
Memory: 32,700 readings
Battery Life: 1 year typical
(1 minute reading rate at 25 °C/77 °F)
Time Accuracy: ±1 minute/month at 20 °C to 30 °C
(68 °F to 86 °F) (Stand alone mode)
Operating Environment: -40 °C to +140 °C (-40 °F to +284 °F),
0 %RH to 100 %RH
Dimensions (Body): 1.6 in x 0.970 in dia. (40 mm x 24.6 mm dia.)
Submersible: Yes (IP68)
Weight: 4.2 oz (120 g)
Material: 316 Stainless Steel
Approvals: CE
High Temperature Data Logger
HiTemp140-1 HiTemp140-2 HiTemp140-5.25 HiTemp140-7 HiTemp140-PT-1

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The IFC400 is an Interface Cable Package for the HiTemp140 Data Logger. Included with the
package is a USB Connection Cable and Docking Station Cradle. The IFC400 Data Logger Interface
allows for a device to be connected to a PC.
IFC400 Product Overview
IFC400 Specifications
Hardware
Operating Environment: -20 °C to +50 °C (-4 °F to +122 °F)
0 %RH to 95 %RH non-condensing
Connection Type: USB (to PC)
Weight: 0.3 lb (140 g)
Material: Acetal Copolymer
Dimensions: 1.95 in x 2.39 in x 1.5 in (49.3 mm x 60.7 mm x 38.1 mm)
Approval: CE
Battery: This device does not use a battery
Interface Cable Package

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TheMadgeTech4SecureSowareaids customersin compliancewith21 CFR Part 11 requirements.
The soware ensures standards in which electronic files are considered equivalent to paper
records, saving time and eort. MadgeTech 4 Secure Soware contains criteria such as electronic
signatures, access codes, secure data files, and an audit trail which meet the requirements of 21
CFR Part 11 and help provide data integrity.
MadgeTech provides on-site IQ/OQ/PQ services to help the user validate the data logging system.
Our trained sta are extremely knowledgeable with the standard IQ/OQ/PQ protocols of the
MadgeTech data logging system. This service is a cost-eective means to save time and ensure
proper implementation of IQ/OQ/PQ of the MadgeTech data logging system with a minimal
disruption to sta and operations. Get more information on our IQ/OQ/PQ On-Site Service.
MadgeTech 4 Secure Software
Software
Cooling Flags Copy to ExcelAutomatic Statistics
Calculation
Tabular Data ViewCustomizable Graphs
P

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Workflows
Configure routine data logging tasks to run
while you are free to do other things. The
Workflows feature enables the automation of
tasks such as creating reports, downloading
data, starting and stopping devices or even
sending email notifications!
Time Markers
Easily mark a desired point in time on any
report using Time Markers. Time Markers
appear as a vertical line in a graph or a colored
row in a data table, Time Markers can help
to organize dierent stages or cycles within
your process or any reference points critical to
interpreting your data as desired.
Advanced Statistics
MadgeTech 4 Secure Soware has expanded
to oer more options and statistics available
for data analysis.
• Time until threshold statistics
• Sterilization Data (F0 and A0)
• Default statistic settings
Great New Features
The MadgeTech 4 Secure Soware is a powerful, intuitive tool containing features that are designed to save on both time
and headaches. Both management and users will find MadgeTech’s new soware exciting: users will love the familiar
interface and numerous shortcuts, while management will appreciate the increased data security and time-saving
elements. Some of the most highly-anticipated new features include:
Administrator & User Settings
Users can be given two levels of access,
either administrator or user. Administrators
have access to all the security settings, while
users only have access to communicate with
the data loggers and analyze data.
Login
Login attempts and lockout duration can
be assigned within the Login tab. There are
numerous password and account settings
for the administrator to set such as the
complexity of the password and status of
each user account. The user management
tab is only available to administrative users.
Groups
Users and Administrators can be assigned to
Groups and can be easily maintained using a
variety of permissions.
Audit Trail
An Audit Trail is kept automatically with
information such as who has logged in and
out, what files were downloaded, save, printed
etc. Each record is date and time stamped and
includes the user information.
Electronic Signature
By clicking the Electronic Signature button,
users and administrators can add electronic
signatures. The electronic signature contains
the printed name of the signer, date and
time of the signing and the meaning of the
signing.

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IQ/OQ/PQ
Installation Qualification (IQ)
• A description of the MadgeTech system
• Verification that all MadgeTech system equipment, soware and accessories are
received in good condition
• A check for complete documentation
• Verification that the installation of MadgeTech equipment is completed properly
• Verification that MadgeTech 4 Secure Soware is installed properly on the target
workstation
• Verification of basic communication between MadgeTech data logger(s) and the
target workstation(s)
Operational Qualification (OQ)
• Functional verification of MadgeTech data loggers
• Handling and maintenance information for the use of MadgeTech equipment
• MadgeTech operating procedures for primary functions
• Verification of proper communication between the MadgeTech data logger(s) and
the workstation(s)
• Verification that the data logger hardware is operational
Performance Qualification (PQ) Recommendation
• Additional handling precautions for maintaining the accuracy of MadgeTech equipment
• Periodic maintenance information for the use of MadgeTech equipment
• Periodic calibration verification in the field
• Comparison of the reported values to a known good standard
• Verification of acceptable performance in the target system
Meeting compliance with regulations for the FDAs Good Manufacturing Practices, or those set forth in Quality Plans, has become increasingly
complex. MadgeTech has simplified this process by including IQ/OQ/PQ protocols with its MadgeTech 4 Secure Soware package.
This enormous time and money saving feature eliminates the need to develop in-house soware validation procedures. The MadgeTech IQ/OQ/
PQ protocol is in support of FDA and cGMP guidelines. In addition, MadgeTech oers a Soware Validation Workbook to help the user verify the
functionality of the soware.
IQ/OQ/PQ Validation Protocol

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Installing the Software
System Installation
1. Inserting the MadgeTech 4 Secure Soware CD into the CD drive on the Windows PC.
An autorun window should appear. If the autorun does not appear, locate the drive on the
computer by selecting the Start menu and choosing Computer or My Computer. Browse to the
CD drive and select the autorun.exe file. For Windows 7 and Windows 8 users, a dialog box may
appear with a list of options. Select Open Folder to View Files and select the autorun.exe file.
2. The MadgeTech 4 Secure Soware Setup Screen will display with options as shown to the le.
3. Installing the Windows Driver
To install the drivers for the IFC406, click on the Install USB Interface Drivers link on the MadgeTech
Installer Options window panel. A window will appear prompting for a directory and to start the
installation. The default directory is C:\Program Files\MTI-USB\Datalogger Interface. If you choose
to change the location of the install directory, select the Change Install Location button. Once you
have the install location set click the Install button to start the installation.
4. Installing the .NET 4.0 Framework
If the Windows PC doesn’t already have .NET 4.0 Framework, installation may be required. If you are running Windows 8, these components are
already installed. To see if the .NET 4.0 Framework is already installed on the Windows PC, go to the Windows Control Panel and select Programs.
“Microso .NET Framework 4.0” would be listed as a Windows program. If the Windows PC doesn’t already have .NET 4.0 Framework, click on
MadgeTech Secure Soware and then select Install .Net 4.0 Framework to install.
5. Installing the MadgeTech 4 Secure Soware
Click on MadgeTech Secure Soware and then select Install MadgeTech Secure Soware. Follow the MadgeTech 4 Secure Setup Wizard on-screen
prompts to complete the installation. The installation of MadgeTech 4 Secure Soware is complete!
Connecting the Data Logger Interface
Test the Data Logger Interface Operation
1. Remove the Warning Label on the IFC406 to expose the USB connector.
2. Connect one end of the USB cable to the USB port of the IFC400.
3. Connect the other end to a USB port on your PC. When the IFC400 is plugged in, a New Hardware Found message will appear in the lower right
corner of your screen. The new drivers will automatically configure themselves for use with the interface cable. A message will then appear that
the new hardware is installed and ready to use.
4. The installation of the USB data logger interface is complete!
To verify that the USB Interface drivers are installed properly, check to ensure the Data Logger Soware can recognize a device.
1. When the interface cable is connected to the PC the blue LED power indicator light should be on.
If the indicator light is not on, unplug the interface cable, wait 5 seconds and plug it back into the PC.
2. Start the MadgeTech 4 Secure Soware.
3. Your device(s) should be listed in the Connected Devices Panel.
A
B
C

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Battery Replacement
Materials needed: ER1425S-HT Lithium Battery
Battery Replacement Procedure:
1. Unscrew the end cap of the data logger to expose the battery.
2. Remove the battery.
3. Place the new battery into the data logger. Note the polarity of the battery.
4. Tightly screw the data logger back together until the O-Rings are no longer visible.
BATTERY WARNING: DISCARD USED BATTERY PROMPTLY. KEEP OUT OF REACH OF CHILDREN. DO NOT DISPOSE OF IN FIRE, RECHARGE, PUT IN
BACKWARDS, DISASSEMBLE, OR MIX WITH OTHER BATTERY TYPES. MAY EXPLODE, FLAME, OR LEAK AND CAUSE PERSONAL INJURY.
Data Logger Maintenance
Recalibration
Recalibration is recommended annually for all MadgeTech data loggers. The Properties window in the MadgeTech 4 Secure Soware displays the
date of the last calibration and the date that the device is next due for calibration. The MadgeTech 4 Secure Soware can also be configured to
send an on screen notification prior to the calibration due date for each device. By default this is set to seven days prior to calibration due date
and can be changed by the user by going to the File tab in the MadgeTech 4 Secure Soware and clicking on Options. Select Device and check
“Display popup notification when a device nears its next calibration date”. The user can then select the number of days before calibration due
date to notify.
HiTemp140 Standard Calibrations Points: 2 points at 30 °C and 140 °C.
Use the MadgeTech RMA System to submit the device for recalibration.
RMA Instructions
To send a device back in to MadgeTech, follow the instructions below to create an RMA (Return Merchandise Authorization) on the MadgeTech website:
1. Visit www.madgetech.com, click on the Services tab, and select RMA Process.
2. When the web page opens, please sign in. If this is the first time, select Create an Account and create one. Once signed in, click on the Make New
RMA button.
3. Complete the applicable fields on the form including customer Billing and Shipping information, even if they are the same. Please see the field
explanation below for a more detailed description about questions asked in the Device Information section.
4. When all of the fields are complete, click Generate RMA.
5. Print out the confirmation page that follows containing the RMA number and MadgeTech’s address for shipping. A Return Merchandise
Authorization must be accompanied by a copy of the RMA paperwork and shipping is prepaid by the customer. The RMA number should be
clearly marked on the outside of the package.
6. Please ship the package via UPS, FedEx, TNT, or DHL to the address listed on the confirmation page. USPS will not ship MadgeTech data loggers.
7. A notification email will be automatically sent when MadgeTech has received the RMA.
Prices and specifications subject to change. See MadgeTech’s terms and conditions at www.madgetech.com.
To send the devices back, visit www.madgetech.com, select Services then RMA Process.

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O-Rings
O-Ring maintenance is a key factor when properly caring for the HiTemp140 and PR140. The O-Rings ensure a tight seal and prevent liquid from
entering the inside of the device.
Materials needed for the HiTemp140: HiTemp140-O-Ring
O-Ring Replacement Procedure:
1. Unscrew the end cap from the data logger to expose the O-Ring.
2. Use a small pointed tool (knife or pick) to pry the old O-Ring out of its groove.
3. Make sure that the O-Ring groove is free of any dirt or debris.
4. Partially screw the mating parts back together leaving the O-Ring groove exposed.
5. Apply a thin coat of silicone based lubricant to the O-Ring.
6. Stretch the O-Ring over the cap and into its groove. WARNING: Avoid stretching the O-Ring over the threads! Sharp threads can cut the new O-Ring.
7. Tightly screw the data logger back together until the O-Rings are no longer visible.
Maintenance:
MadgeTech data loggers come directly from the factory with high quality O-Rings that have been properly installed. As a user, there are only a
few things that need to be remembered to maintain a functional O-Ring seal.
DO:
• Clean them frequently (use compressed air or a so brush to avoid abrasion).
• Lubricate regularly (if it doesn’t feel slippery, it needs to be lubricated). We recommend Parker® Super-O-Lube, but any silicone based O-Ring
lubricant will work. This is most important on the seals that are frequently opened and closed for communication with the logger.
• Inspect the O-Ring regularly for signs of failure.
DON’T:
• Poke, jab, pry at the O-Ring with sharp or pointed objects.
• Expose the O-Rings to harsh chemicals.
• Expose the seals to high pressure (the HiTemp140 and PR140 data loggers are rated to 60 PSIG).
• Expose the seal to high temperatures (see specification for operating temperature range).
Data Logger Maintenance
Support
For more assistance with our products, please contant us using the information below
Phone & Fax
Sales & General Inquiries: [phone]
Fax: [phone]
E-mail
General Information: [e-mail]
Sales: [e-mail]
Customer Support: [e-mail]
Mailing Address
MadgeTech, Inc
6 Warner Road
Warner, NH 03278
Hours of Operation
Monday - Friday,
8:00am - 5:00pm EST
Website
Visit our Online Knowledge Base
at www.madgetech.com/kbase

DOC-1293-036-00 Rev2 2014.10.30
MadgeTech, Inc. . 6 Warner Road . Warner, NH 03278
Tel: [phone] . Fax: [phone] . [email protected] . www.madgetech.com