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3M MDS100 User Manual

EN
Molecular Detection System User Manual
MDS100
EN
(English)
3
Issue Date: 2011-11
Molecular Detection System User Manual MDS100

Table of Contents

Table of Contents ..................................................................1
Using this Manual .................................................................3
Intended Use ................................................................3
User Responsibility ....................................................... 4
Safety Information ................................................................4
Important Informational Reading .................................. 4
Instrument Specifications .....................................................6
Electrical Specifications ...............................................6
Environmental Operating Conditions ............................. 6
Instrument Specifications .............................................6
Regulatory Information .........................................................7
Safety Standards ......................................................... 7
EMC Standards ............................................................ 7
European Directives ..................................................... 7
Agency Approval Marks .............................................. 7
FCC Information ........................................................... 7
Setting up the 3M Molecular Detection System ....................7
Package Contents ........................................................ 7
Minimum Computer Requirements ...............................8
Unpacking and setting up the Instrument ..................... 8
Operating the 3M Molecular Detection Software .................18
Logging in .................................................................. 18
Using the Start Page .................................................. 19
Using the Collapsing Sidebar ...................................... 19
Using the Menu Bar ................................................... 20
Setting up the Administrative Information ...........................24
Users ......................................................................... 24
Adding users .............................................................. 24
Deleting users ............................................................ 25
Hiding users ............................................................... 25
Changing passwords ..........................................................25
Viewing users ............................................................25
Instruments ...............................................................26
Adding instruments .................................................... 26
Naming instruments................................................... 27
Hiding instruments ..................................................... 27
Changing the order of instruments ............................. 27
Deleting instruments .................................................. 27
Viewing instruments ..................................................28
Configuring Fields ...................................................... 28
Samples ....................................................................30
Adding samples ......................................................... 31
Modifying samples .....................................................31
Deleting samples ....................................................... 31
Hiding samples .......................................................... 31
Importing samples ..................................................... 32
Exporting samples ..................................................... 34
Assay Kits .................................................................. 34
Adding Assay Kits ...................................................... 34
Deleting Assay Kits .................................................... 35
Hiding Assay Kits ...................................................... 35
Using the Status Bar .................................................. 21
Shutting down the software ....................................... 21
Logging out ............................................................... 21
Monitoring the instrument status ............................... 21
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Performing Runs ................................................................36
Setting up a new run ................................................. 36
Starting a run ............................................................ 40
Importing a new run .................................................. 40
Exporting a run definition ........................................... 41
Displaying a run by assay type .................................. 41
Saving a run as a template ........................................ 42
Setting up a new run from a template ....................... 42
Viewing run results .................................................... 44
Exporting run results.................................................. 47
Generating run reports ............................................... 48
Run Layout Report ..................................................... 48
Run Report ................................................................ 48
Instrument Temperature Log ...................................... 48
Opening a saved run .................................................. 48
Deleting a run ............................................................ 49
Generating Management Reports ....................................... 51
Generating a Search Results report ........................... 51
Generating a Samples report ..................................... 52
Generating an Assay Kits report ................................. 53
Generating a Completed Runs report ......................... 54
Generating an Audit Log report .................................. 55
Generating User Reports ............................................ 56
Generating an Instrument Self-Check Results report . 56
Generating an Instrument Temperature Log report ....57
Terms and Definitions .........................................................58
Cleaning and Decontaminating the Instrument ...................76
Cleaning the External surfaces .................................. 76
Decontaminating the interior ..................................... 76
Packing the instrument for shipment to 3M for service ......78
Troubleshooting ..................................................................80
Troubleshooting the 3M Molecular
Detection Instrument ................................................. 80
Troubleshooting 3M Molecular
Detection Software Installation .................................. 81
Troubleshooting 3M Molecular
Detection Software Operation .................................... 83
Contacting 3M for product and service information ............ 84
3M Technical Support ................................................ 84
Trademarks ........................................................................84
Appendix ............................................................................84
Example Reports ................................................................85
Search Results .......................................................... 85
Samples Report ......................................................... 86
Assay Kits Report ....................................................... 87
Completed Runs Report ............................................. 88
Users Report .............................................................. 89
Instrument Self-Check Report ................................... 90
Instrument Temperature Log ...................................... 91
Audit Log .................................................................. 92
Run Layout ................................................................ 93
Run Report (with graphs enabled).............................. 94
Administrator Tasks ............................................................59
Backing up the Database ........................................... 59
Restoring the Database from a Backup ..................... 63
Uninstalling the Software ........................................... 66
All Programs Menu .................................................... 66
Uninstall.exe .............................................................. 66
Control Panel ............................................................. 66
Running a 3M Molecular Detection
Instrument Self-Check ............................................... 67
Before you begin ....................................................... 67
Starting a Self-Check ................................................. 68
Viewing the Error Log File .......................................... 68
Upgrading the Firmware in Windows XP .................... 68
Upgrading the Firmware in Windows 7/Vista .............71
Example Import/Export Files ...............................................96
Sample Comma Separated Values (.CSV) File ............ 96
Run Setup Comma Separated Values (.CSV) File ........ 96
Run Results Comma Separated Values (.CSV) File ..... 97
License agreement .............................................................98
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Using this Manual

1. The 3M™ Molecular Detection System User Manual is provided in electronic format only. To access the user manual, click [Help] on the menu bar, and then select User Manual.
2. Click any item in the Table of Contents to immediately bring you to that section, or scroll or page through the User Manual to the desired section.
3. 3M Molecular Detection Software updates will include updates to this User Manual, which will automatically be installed along with the software updates.
4. This User Manual describes the operation and behavior of the 3M Molecular Detection System Software, and it is structured to provide step-by-step instructions for the operational tasks that users carry out. It is organized with the assumption that users prefer to search the Table of Contents for a specific task they want to carry out and follow step-by-step instructions for that task.
5. In the step-by-step instructions for using the software, the following style guidelines were used: a. Italic type is the name of a window
b. Bold type is the exact text of something that appears on a window c. [Bold type with brackets] is the name of a button that you can click on a window

Intended Use

The 3M™ Molecular Detection Instrument is designed for use with 3M™ Molecular Detection Assays for the rapid detection of pathogens in enriched food and food process environmental samples, through the use of isothermal amplification and bioluminescence. Contact your official 3M Food Safety representative for a current listing of 3M Molecular Detection Assays documented for use with the Molecular Detection Instrument. 3M has not designed nor documented the 3M Molecular Detection Instrument for use with other manufacturer’s molecular assays. The unit has been designed and tested to only be used with the Power Supply module designated and supplied by 3M Company. 3M anticipates that the 3M Molecular Detection Instrument will be utilized by technicians that have been properly trained in the use of the 3M Molecular Detection Instrument and 3M Molecular Detection Assays. The 3M Molecular Detection Instrument is intended for use with samples that have undergone heat treatment during the assay lysis step, which is designed to destroy organisms present in the sample. Samples that have not been properly heat treated during the assay lysis step may be considered a potential
biohazard and should NOT be inserted into the 3M Molecular Detection Instrument.
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User Responsibility

USER RESPONSIBILITY Users are responsible for familiarizing themselves with product instructions and information. Visit our website at www.3M.com/foodsafety, or contact your local 3M representative or distributor for more information.
When selecting a test method, it is important to recognize that external factors such as sampling methods, testing protocols, sample preparation, handling, and laboratory technique may influence results.
It is the user’s responsibility in selecting any test method or product to evaluate a sufficient number of samples with the appropriate matrices and microbial challenges to satisfy the user that the chosen test method meets the user’s criteria.
It is also the user’s responsibility to determine that any test methods and results meet its customers’ and suppliers’ requirements.
As with any test method, results obtained from use of any 3M Food Safety product do not constitute a guarantee of the quality of the matrices or processes tested.

Safety Information

Important Informational Reading

Please read, understand, and follow all safety information contained in this User Manual prior to and during the use of the 3M Molecular Detection System. Retain these instructions for future reference.
Explanation of Signal Word Consequences
Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
WARNING:
Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.
CAUTION:
NOTICE:
Indicates a situation which, if not avoided, could result in property damage only.
Summary of instrument labels containing safety information
Hazardous Voltage
Read Accompanying Documentation
Hot Surface
This system is subject to the European WEEE Directive 2002/96/EC. This product contains electrical and electronic components and must not be disposed of using standard refuse collection. Please consult local directives for disposal of electrical and electronic equipment.
CAUTION: Recycle to avoid environmental contamination This product contains recyclable parts. For information on recycling - please contact your nearest 3M Service Center for advice.
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WARNING
• To reduce the risks associated with hazardous voltage and fire:
- keep power supply visible and accessible at all times. Use the plug at the wall socket to disconnect the device from the main power supply.
- use only the power cord specified for this product and certified for the country of use.
- do not allow the power supply to get wet.
- do not modify, or service this instrument. Use only 3M authorized service personnel.
- do not use the power supply if the enclosure is broken.
- do not use this instrument if power cord is damaged. Use only 3M authorized service personnel. Use only 3M specified replacement parts.
• To reduce the risks associated with exposure to chemicals and biohazards:
- always follow standard lab safety practices, including wearing appropriate protective apparel and eye protection while using this instrument.
- always perform the decontamination procedure prior to returning the instrument for service and prior to disposal.
• To reduce the risks associated with false-negative results leading to the release of contaminated product:
- install instrument on a solid, dry, level surface, allowing approximately 30cm of clearance above the unit for opening the door.
- do not use the instrument when it appears the instrument or any component is damaged.
• To reduce the risks associated with amplicon contamination and false-positive results:
- do not open reagent tubes after a run is completed.
- decontaminate the 3M Molecular Detection Instrument regularly with a 1-5% (v:v in water) household bleach solution (refer to Cleaning section).
CAUTION
• To reduce the risks associated with exposure to chemicals:
- read, understand and follow the safety information on the isopropanol and bleach containers and their associated MSDS’.
• To reduce the risks associated with environmental contamination:
- follow applicable regulations when disposing of this device or any of its electronic components.
• To reduce the risks associated with hot surfaces:
- avoid direct contact with the aluminum heating block insert when hot.
NOTICE
• To avoid instrument damage:
- do not use solvents such as acetone or thinner to clean the instrument; avoid abrasive cleaners.
- clean instrument exterior with soft cloth using plain water or a mild, all-purpose or nonabrasive cleaner.
- Only use the recommended cleaning and disinfection agents specified in these instructions. Contact the manufacturer if there is any doubt about the compatibility of these agents with any part of the equipment.
- If the equipment is used in a manner not specified in this manual, the protection provided by the equipment may be impaired.
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Instrument Specifications
Electrical Specifications
Model MDS100 Specification Units
Voltage 24 V VDC
Current 2.5 A Amps
Power Supply Specification Units
Input Voltage 100-240 V VAC
Frequency 50/60 Hz Hertz
Maximum Input Current 1.5 A Amps
Output Voltage 24 V VDC
Output Current 2.5 A Amps

Environmental Operating Conditions

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(English)
Environmental Condition Operating Condition Units
Altitude Max 2000 m meters
Operating Temperature 15°C – 40°C °C
Storage Temperature -10°C – 60°C °C
Relative Humidity 30–80% non-condensing %
Pollution Degree 2
Installation (Overvoltage) Category II
Indoor use only
Instrument Specifications
Length 292 (11.5) mm (in)
Width 213 (8.4) mm (in)
Height 96 (3.8) mm (in)
Weight 4.3 (9.5) Kg (lbs)
Specification Units
External Connectors USB 2.0 type B connector
Male 2.1 mm ID 5.5 mm OD Jack
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Regulatory Information

EN
(English)

Safety Standards

IEC/EN 61010-1, 2nd Edition
UL 61010-1
CAN/CSA C22.2 No. 61010-1
EIC 61010-2-081

European Directives

Low Voltage Directive
EMC Directive
RoHS
WEEE
REACH

EMC Standards

USA: FCC part 15 subpart B
Canada: ICES-003
EEA: EN 61326
Australia: AS/NZF 2064.1/2

Agency Approval Marks

UL (USA)
C-UL
CE
FCC / IC
C-tick (3M code is N1108)
CB Scheme
CCC

FCC Information

This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide a reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the Installation and Use Guide, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case, the user will be required to correct the interference at his/her own expense.

Setting up the 3M Molecular Detection System

Package Contents

3M™ Molecular Detection Instrument MDS 100 External Power Supply External Power Supply Cord(s) USB Cable (1) 3M™ Molecular Detection Software Disc (1) 3M™ Molecular Detection Speed Loader Tray (1) 3M™ Molecular Detection Chill Block Insert (1) 3M™ Molecular Detection Chill Block Tray (1) 3M™ Molecular Detection Cap/Decap Tool – Lysis (1) 3M™ Molecular Detection Cap/Decap Tool – Reagent (1) Lysis Tube Rack (1) Reagent Tube Rack (1)
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Minimum Computer Requirements

• Microsoft® Windows® XP with Service Pack 3 (SP3), or Microsoft® Windows® Vista with Service Pack 2 (SP2), or Microsoft® Windows® 7 (32- or 64-bit)
• 2.0 GHz Intel Pentium 4 or similar processor
• 2 GB RAM (3 GB RAM recommended)
• 20 GB of free disk space
• CD/DVD Drive
• USB 2.0
The 3M Molecular Detection System is based on the Microsoft.NET Framework 4 platform and utilizes a local Microsoft SQL Server 2008 R2 Express database for data storage. These components are included in the 3M Molecular Detection Software package and can be installed during software installation if not already present on the computer. If you are using a Windows XP computer, you must install additional Microsoft components before installing the 3M Molecular Detection Software. These components are available for free download from the Microsoft website. Refer to the Installing the Software section in this manual for more information.
Although Microsoft SQL 2008 R2 Express is free, it has a database size limitation. Over time, this size limitation may impact the performance of the 3M Molecular Detection Software. Please consult Microsoft’s web site for more information.
The 3M Molecular Detection Software is a Microsoft Windows computer software application that communicates with up to four (4) 3M Molecular Detection Instruments for the purpose of testing for pathogens in food. The 3M Molecular Detection Software is a stand-alone software application in that it does not require network connectivity to function.

Unpacking and setting up the Instrument

1. The 3M Molecular Detection Instrument arrives in a disposable shipping container. The 3M Speed Loader Tray and pluggable heater components arrive in a separate box within the shipping container.
2. Open the shipping container to expose the 3M Molecular Detection System and its accessories.
3. Examine the 3M Molecular Detection System and its accessories for damage. If any shipping damage is found when unpacking the 3M Molecular Detection System, immediately file a damage claim with the transportation company and notify your 3M sales or service representative.
4. Install the 3M Molecular Detection Software on your computer before connecting the 3M Molecular Detection Instrument to your computer. Open the software after installation is complete. Refer to the section in this manual on installing the software.
5. Lift the instrument from the shipping container and place the instrument in its permanent location on a level surface.
6. Remove the pluggable heater and the 3M Speed Loader Tray from the shipping container and place them next to the instrument.
3M Speed Loader Tray
Pluggable Heater
3M Molecular Detection System Instrument
7. Using a small flat-head/slotted screwdriver, remove the silver screw covering the emergency lid release button located on the bottom of the instrument. After removing the screw, insert a thin object into the hole (e.g., a small screwdriver or unfolded paper clip) to engage the button and release the lid.
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8. Use a disposable towel lightly dampened with DI water (distilled or deionized water) to gently wipe any dust or debris from the inner surfaces of the instrument.
9. Use a dry disposable towel to wipe the interior surfaces of the instrument.
10. Allow the interior surfaces of the instrument to air dry for at least 1 hour. Do not reconnect the power cable and the USB cable until you have allowed the instrument to air dry for at least 1 hour.
11. Insert the pluggable heater into the instrument and align the three screws with the holes. If the pluggable heater is level with the instrument, it was inserted correctly. If the pluggable heater is tilted 45 degrees, it was inserted backwards and it must be reinserted so it is level with the instrument.
3M Speed Loader Tray
3M Molecular Detection System Instrument
12. Use a screwdriver to turn the three Phillips-head screws on the pluggable heater a quarter turn clockwise to fasten the pluggable heater into the instrument.
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13. A minimum of 40.6 cm (16 in) of space above the bench top is required to allow for opening the instrument lid to insert or remove the 3M Speed Loader Tray.
14. Select the appropriate external power supply cord for your region, and connect the cord to the 3M provided external power supply.
15. Connect the power supply cord to the 3M Molecular Detection Instrument’s power port on the back panel of the instrument, and connect the outlet plug on the power supply cord to a grounded AC power (100-240VAC +/- 10%) outlet. The power supply and/or the power supply plug must be easily accessible for quick disconnect.
16. Insert the USB cable into the 3M Molecular Detection Instrument’s USB 2.0 port on the back panel of the instrument, and connect the other end of the cable to your computer’s USB 2.0 port.
17. Turn the 3M Molecular Detection Instrument on using the on/off switch located on the back panel of the instrument.
18. Windows detects the presence of a new device and automatically installs the device driver software for the new device.
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Installing the Software

The 3M Molecular Detection Software comes packaged with Microsoft.NET Framework 4 and Microsoft SQL Server 2008 R2 Express. To install the 3M Molecular Detection Software, you must be logged onto Windows as an administrator or
belong to the Administrators group.
If you are using a Windows XP or Vista computer, you must install the following Microsoft components before installing the 3M Molecular Detection Software. These components are available for free download from the Microsoft website. These components are available in multiple languages and either 32- or 64-bit, so download the version appropriate for your computer.
Before using the 3M Molecular Detection Software, disable Windows power management features such as Sleep or Hibernate to prevent accidental termination of the software and any active runs.
Windows XP with SP3 Windows Vista with SP2
Windows PowerShell 1.0 Windows PowerShell 2.0
Windows Installer 4.5 .NET Framework 3.5 SP1
.NET Framework 3.5 SP1
Do not log out of Windows or switch Windows user accounts while a run is active, as this will cause the run to be terminated.
1. Insert the 3M Molecular Detection Software Disc into your computer’s CD/DVD drive.
2. Use Windows Explorer to navigate to the drive and double-click 3M.Mds.exe to start the installation wizard. Note: For Windows Vista and 7, you must right-click 3M.Mds.exe and select Run as administrator to start the installation wizard.
3. The installation wizard displays the 3M Molecular Detection Software Setup window. It may take a few minutes for this window to appear. Click [Next] to continue.
4. Read the 3M End User License Agreement, and then click the [I Agree] button to accept the 3M End User License Agreement and to continue with the installation wizard.
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5. The installation wizard checks your computer’s configuration for the software components required for the 3M Molecular Detection System. The first check is for Microsoft.NET Framework 4. If it is not present, the installation wizard starts the .NET 4 installation process. This document does not describe the entire .NET installation process. For more information on the purpose, content and installation process for the Microsoft.NET 4 component, visit http://www.microsoft.com and search for .NET Framework 4 Standalone Installer.
6. The .NET installer starts with the Microsoft.NET Framework 4 Setup window.
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7. Read the the Microsoft license terms, and then click the I have read and accept the license terms check box to accept the Microsoft license terms and click the [Install] button.
8. After installation is complete, a computer restart may be required. In this case, close the installation wizard, restart the computer, and then repeat steps 2-4.
9. In the SQL Server setup screen, select Install Microsoft SQL Server 2008 R2 Express for a new SQL Server installation. For more information on Microsoft SQL Server products and their limitations, please consult Microsoft’s web site at http://www.microsoft.com/sqlserver.
Note: If a SQLMDS server is already present on the computer (e.g., if reinstalling or upgrading the software), select Use existing SQL Server and skip to step
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10. When the SQL Server Installation Center opens, select [New installation or add features to an existing installation and click [Next].
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11. Read and accept the SQL Server license agreement.
12. In the Feature Selection screen, click [Next] to accept the default Instance Features, Shared Features, and directory location. Do not uncheck any features.
13. In the Instance Configuration screen, click [Next] to accept the SQLMDS Named instance and default root directory.
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14. In the Server Configuration screen, select NT AUTHORITY\SYSTEM for the Account Name field for the SQL Server Database Engine. No Password is required. Click [Next] to continue.
15. Click [Next] to accept the default Windows authentication mode. Click [Add] to specify additional users, if necessary. Click [Next] on the following screen to start the installation. An installation progress screen is shown.
16. Following successful installation, the installation wizard displays a completion message. Click the [Close] button.
17. After installation is complete, a computer restart may be required. In this case, close the installation wizard, restart the computer, and then repeat steps 2-4.
18. In the SQL Server setup screen, select Use existing SQL Server and click [Next].
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19. In the Database Connection Settings screen, the Server Name will be automatically populated. This screen may be blank for a few seconds. Click Next to accept the default settings unless you have a specific reason to edit them.
20. Click the [Test Connection] button to verify that the Server Name is correct. If the test fails, enter the <Computer_ Name>\SQLMLDS as the Server Name. You can find the value for <Computer_Name> by following these steps:
a. Click Start on the Windows Desktop b. Select My Computer c. Select View Computer Information d. Select the Computer Name tab
Note: If a 3M Molecular Detection Software database is present on the computer (e.g., if you are re-installing or upgrading the software) Use existing database is selected by default to connect to the existing database and preserve the data. If this option is not selected and you want to use an existing database, be sure to select Use existing database checkbox and select the Mds database from the drop-down list. If a 3M Molecular Detection Software database is present, but you would like to create a new database, uncheck this setting. This will erase all data in the existing database, so be sure you have backed up the database prior to this step.
21. The installation wizard asks for your name and address. This information is required.
22. Setup an initial Administrator user. This is required. Enter all the information listed below, and then click the [Next] button. All fields are required.
a. Enter a full name for the administrator user in the Full Name field. Any text string is allowed. b. Enter the user name to be used at login in the User Name field. Any text string is allowed. The user name is not
case sensitive. c. Enter the password in the Password field. Any text string is allowed. The Password is case sensitive. d. Enter the Password again to confirm it in the Confirm Password field. The Password and Confirm Password that
you enter must be identical.
Note: After installation, the password cannot be recovered if forgotten. If you forget the password, you must re-install the Molecular Detection Software and create a new database.
The 3M Molecular Detection Software does not enforce any restrictions on the structure of login names or passwords. If security is important, you are urged to follow secure name and password best practices. Both IBM and Microsoft provide free security best practice guidelines. See http://www.ibm.com/developerworks or http://technet.microsoft.com for more information.
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23. Click [Next] to continue with the installation wizard.
24. Select a format for the default Run ID. The available formats of the default Run ID all include the current date followed by the creation sequence number. The date format is a two digit month, two digit day and either a two or four digit year. The sequence number is created by the system and can be a one, two or three digit number enclosed by parenthesis, hyphens or underscores.
25. Click [Next] to continue with the installation wizard.
26. The software provides optional, customizable fields used to describe samples. The default values for these fields are listed in this table. You can accept these default values by clicking [Next] on the Custom Fields Configuration window, or you can customize these fields by using the options available. Note: You will not be able to customize these fields, except for the Show option, after the installation process is complete.
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Sample Fields Field Name Field Type Field Values Show
Raw
Field 1 Sample Type List
Processed
Show
Environmental
Field 2 Description Text Show
Field 3 Product Text Show
Field 4 Brand Text Show
Field 5 Lot Number Text Show
Field 6 Line Text Show
Field 7 Customer Text Show
27. To modify any of the default fields, perform the following actions.
a. Use the Field dropdown menu to select the field you want to change. There are seven fields total. b. Enter the new Field name into the Field Name field. c. Use the Field type dropdown menu to select the Field type.
i. Text – You can enter any free-format text into a text field.
ii. List – You must select a field value from a predefined list for a list field.
d. If you selected List in the previous step, enter the items for the pre-defined list into the Field values field. You
can add field values to the Field values list after you click [Next] in this Custom Fields Definition window and complete the installation. However, you cannot remove field values from the Field values list after you click Next in this Custom Fields Definition window (step 29 below) and complete the installation.
e. Click the icon to add a field value. This opens a textbox (shown to the right) where
you enter the new field value.
f. Accept the new field value you entered by clicking the icon. g. Select the Show checkbox to show the selected field, or clear the Show checkbox to hide the selected field. If a
field is hidden, it is not used in sample definition or report generation. This can also be changed after installation.
28. Repeat the above steps for each of the fields you want to change.
29. Click the [Next] button when you finish customizing these fields.
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30. In the Import/Export Options screen, you can select the default locations for import and export files. This can also be changed after installation, in the Administration>Import and Export Options menu.
31. In the next three screens, the installation wizard asks for the Destination Folder, the locations for Application Shortcuts and the Start Menu Folder. You can modify the defaults for these fields if necessary. If you don’t have a specific reason to modify these fields, the default values are recommended. Click [Next] to proceed through each screen.
a. Destination Folder – This is the root installation directory for the 3M Molecular Detection Software. b. MDS Application Shortcuts – These are the locations where the installation wizard will place the 3M Molecular
Detection Software shortcuts.
c. Start Menu Folder – This is the location within the Start menu where the installation wizard will place the 3M
Molecular Detection Software shortcut.
32. Click [Install] on the Choose Start Menu Folder window to begin the installation. A progress bar is shown.
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33. Click [Finish] when the installation wizard displays the Completing the 3M Molecular Detection Software Setup Wizard window.

Operating the 3M Molecular Detection Software

Before using the 3M Molecular Detection Software, disable Windows power management features such as Sleep or Hibernate to prevent accidental termination of the software and any active runs.
Do not log out of Windows or switch Windows user accounts while a run is active, as this will cause the run to be terminated.

Logging in

1. To start the 3M Molecular Detection Software, go to the Windows Start Menu, select Programs then select 3M
Molecular Detection System, or double click the icon located on the Microsoft Windows desktop.
2. Enter your user name in the User Name field and enter your Password.
3. To select a language for the user interface other than the default language (English), use the Language dropdown menu to select the language for the user interface.
Login Screen
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Using the Start Page

1. The 3M Molecular Detection Software displays the Start Page window after you login successfully. You can select and perform the following operations from the Start Page by clicking the text beside the icons.
• Setup New Run – Create a new Run definition
• Start Configured Runs – Start a Run that was previously defined
• View Run Results – View the results from a previously executed Run
• Generate Reports – Create various standard reports or search results in the database
• Administration – Administer and configure 3M Molecular Detection System software
• User Manual – Open the 3M Molecular Detection System User Manual (this document).
2. If you want to close the Start Page, click the close icon on the Start Page tab.
3. You can open the Start Page at any time.
a. Select [View] on the menu bar. b. Select Start Page. The Start Page with the collapsing Sidebar, Main Menu and Status Bar is shown below.
Start Page

Using the Collapsing Sidebar

1. Select [View] on the menu bar.
2. Select Sidebar Menu to make the Sidebar button appear on all panes regardless of the active tab. The Sidebar Menu is a toggle feature, which means you can turn it on by selecting it and turn if off by selecting it again. If a check mark appears next to the Sidebar Menu option in the View menu, the feature is on. If a check mark does not appear next to the Sidebar Menu option in the View menu, the feature is off.
3. Hover the cursor over the Sidebar button to open the Collapsing Sidebar.
4. You can click the Autohide button next to the exit button on the sidebar to toggle the Autohide function.
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5. From the Collapsing Sidebar, you can select and perform the following operations by clicking the text beside the icons.
• Setup New Run – Create a new Run definition
• Start Configured Runs – Start a Run that was previously defined
• View Run Results – View results from a previously executed Run
• Generate Reports – Create various reports for Samples, Assay Kits, Runs and Instruments
• Manage Samples – Create and modify Sample definitions
• Manage Assay Kits – Create and modify Assay Kit definitions

Using the Menu Bar

The Menu Bar is available at all times. You can use the Menu Bar to perform most tasks in the 3M Molecular Detection System application software. The menu items in italic are restricted to Administrator users.
1. Click the item on the menu bar you want to use.
2. Click the item you want to use on the cascading menu that appears.
Menu Bar Item Description
File
New Run Create a new Run definition Open Runs… Search for previously defined Runs Load Run Template… Create a Run from a saved Template Save Run Save the Run definition Save Run as Template… Save the Run definition as a Template Print… Print the Run definition Logout… Logout of the software, display Login screen Exit Exit the software
Manage
Samples… Create and manage Sample definitions Assay Kits… Create and manage Assay Kit definitions
Reports
Search Results… Report of test results across multiple Runs Samples… Report of all Samples defined in the system Assay Kits… Report of all Assay Kits defined in the system Completed Runs… Report of all successfully completed Runs Users… Report of all Users defined in the system Instrument Self-Check Results… Report of Instrument diagnostics Instrument Temperature Log… Report of Run temperature readings
Administration
Users… Create and manage Users Instruments… Manage the known instruments Configure Fields… Change the user-defined Sample and Assay Kit fields
Import and Export Options… Set options for importing and exporting data Audit Log… Report of user activity Change Password… Change the active user’s password Options… Additional administrator options
View
Start Page Display the Start Page Sidebar Show/Hide the Sidebar
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Help
User Manual Display the User Manual About 3M Molecular Detection System Display the About screen

Using the Status Bar

1. The 3M Molecular Detection Software displays a status bar at the bottom of the software’s main window. This status bar contains three components. From left to right, these components are:
1. Current user – User Name of the user who is currently logged-in.
2. Instrument status – Status of the 3M Molecular Detection Instruments currently connected to the system. Refer to the section in this manual on monitoring the instrument status for more information.
3. Status message – System informational messages.

Shutting down the software

1. You can use either of two ways to shut down the software. a. Select [File] on the menu bar, and then select Exit
b. Click the close button
2. Shutting down the software logs out the current user, terminates any active test runs (confirmation required), places all
connected devices in Standby mode, and terminates the software.

Logging out

1. Select [File] on the menu bar, and then select Logout…
2. The 3M Molecular Detection Software displays the Login window. Refer to the section in this manual on logging in for
more information.
3. Logging out of the software logs out the current user, terminates any active test runs (confirmation required), places all
connected devices in Standby mode, and returns to the login screen.

Monitoring the instrument status

You can check the status of an instrument in the following ways:
• Check the color of the instrument’s status light.
• Hover the cursor over an instrument icon in the software status bar to display the detailed status information
about that instrument. An example of this is shown below.
• Double-click an instrument icon in the software status bar, or you can right-click an instrument icon and
then select Show instrument status tab. This opens a new tab with detailed status information about the instrument. An example of this is shown below
Instrument Status Tooltip
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Instrument Status Tab
Field Name Description
Instrument Name The instrument name you defined when you added the instrument
Instrument Status The instrument’s current operational status. Refer to the table of operational
statuses below.
Lid State The instrument’s lid status (open or closed)
Lock State The instrument’s lid lock status (locked or unlocked)
Heater State The instrument’s heater status (on or off)
Core Temperature The temperature of the instrument’s pluggable heater in degrees Celsius
Lid Temperature The temperature of the instrument’s lid heater in degrees Celsius
Last Self-Check Result The results of the last previous diagnostic test done on the instrument
Serial Number The instrument’s serial number
Firmware Version The instrument’s firmware version number
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Status Light Icon Instrument Status
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Off
Off
Orange
Orange
Green
Green
(White)
(White)
(Orange)
(Orange)
(Green)
(Green)
The instrument is in Standby state while it waits to start the heaters to perform a test run, and the lid is closed.
OR
The instrument is in Diagnose state while it runs a Self-Check, and the lid is closed.
The instrument is in Standby state while it waits to start the heaters to perform a test run, and the lid is open.
OR
The instrument is in Diagnose state while it runs a Self-Check, and the lid is open.
The instrument is in Heat state with the temperature increasing to the required level, and the lid is closed. The instrument is not yet ready to perform a run.
The instrument is in Heat state with the temperature increasing to the required level, and the lid is open. The instrument is not yet ready to perform a run.
The instrument is in Ready state with the temperature at the required level, and the lid is closed. The instrument is ready to perform a run.
The instrument is in Ready state with the temperature at the required level, and the lid is open. The instrument is ready to perform a run.
Blue
Red
Flashing
Red
The instrument is in Test state while it performs a run, and the lid is closed.
(Blue)
The instrument is in Test Complete state after it completes a run, and the lid is closed.
(Red)
The instrument is in Failed state after it fails a Self-Check.
(Flashing Red)
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Setting up the Administrative Information

Users

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Users Window

Adding users

Only administrator level users can add users.
1. Click [Administration] on the menu bar, and then select Users….
2. The Setup window displays a current list of users on the Users tab in the sequence in which they were added.
3. Click the [Add] button to add a new user.
4. Enter the new user’s full name in the User Full Name field. This is the name that appears on reports and on windows in the 3M Molecular Detection Software. This is typically the user’s first name and last name. This field is required.
5. Enter the new user’s user name in the User Name field. This is the name that the user enters in the User Name field in the Login window. The user name is case sensitive. This field is required.
6. Use the Role drop-down menu to select a role for the new user. This field is required.
• A User (standard user) can define and manage Assay Kits, Samples and Runs, execute Runs, create reports and perform limited instrument management.
• An Administrator can perform all activities of a user plus user management, full instrument management control, and other options.
7. Enter the new user’s password in the Password field. The password is case sensitive. The password is displayed as ***** as you enter it. This field is required.
8. Enter the new user’s password again in the Confirm password field. This field is required.
9. Click the [Apply] button to apply the addition, or click the [OK] button to apply the addition and return to the Start Page
window.
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Deleting users

Only administrator level users can delete users.
1. Click Administration on the menu bar, and then select Users….
2. The Setup window displays a list of active users on the Users tab in the sequence in which they were added.
3. Click the user you want to delete from the list. You cannot delete a user that has defined any system component (Assay Kit, Sample, Run). Users cannot delete themselves.
4. Click the [Delete] button.
5. Click the [Apply] button to apply the deletion, or click the [OK] button to apply the deletion and return to the Start Page window.

Hiding users

Only administrator level users can hide users. You should hide users who are no longer using the 3M Molecular Detection Software, but who have defined any system component (Assay Kit, Sample, Run) in the past. Hiding a user removes the user name from the user name list while leaving the user in the database. This allows management of active users while maintaining the integrity of historical data.
1. Click Administration on the menu bar, and then select Users….
2. The Setup window displays a list of active users on the Users tab in the sequence in which they were added. Click the user you want to hide.
3. Click the [Hide] button.
4. Click the [Apply] button to apply the deletion, or click the [OK] button to apply the deletion and return to the Start Page window.

Changing passwords

1. Click [Administration] on the menu bar, and then select Change Password….
2. The Change Password window displays the current user
3. Enter the user’s current password in the Current Password field.
4. Enter the user’s new password in the New Password field.
5. Enter the user’s new password again in the Confirm Password field.
6. The password you enter into the New Password field and the password you enter into the Confirm Password must match exactly. If they do not match exactly, an error message will appear. The password is case sensitive. The password is displayed as ***** as you enter it.
7. Click the [OK] button to apply the change.

Viewing users

1. Click Administration on the menu bar, and then select Users…
2. The Setup window displays a list of active users on the Users tab in the sequence in which they were added. Show all hidden users in addition to active users by clicking the Show hidden checkbox.
3. Click the user you want to view.
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Instruments

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Instruments Window

Adding instruments

The 3M Molecular Detection Software automatically detects instruments that are powered on and are connected to the computer by a USB cable when the software starts. The software also automatically detects instruments when you power on instruments and connect instruments to the computer by a USB cable.
1. Click Administration on the menu bar, and then select Instruments…. The Instrument tab on the Administration window displays all instruments that have been automatically detected.
2. The 3M Molecular Detection Software detects and manages a maximum of four instruments. A USB hub may be needed to support the maximum number of instruments.
3. When the 3M Molecular Detection Software detects an instrument, it retrieves the instrument’s serial number from the instrument and stores the serial number in the serial number field. You cannot change the instrument serial number.
4. The 3M Molecular Detection Software also uses the serial number as the default device name. You can change the device name along with the device description (initially blank). The device name and description can be any free-format text.
5. The 3M Molecular Detection Software automatically initializes an instrument when it detects the instrument. The sequence of detection is determined by the underlying Microsoft Windows operating system. It may not have any relationship to specific USB ports. Initialization consists of these steps:
• Establishes USB communication with the instrument
• Unlocks the instrument
• Performs basic diagnostic tests on the instrument
• Terminates any active test runs
• Turns on the instrument’s heaters
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6. The instrument status bar displays only the first four instruments in the Instruments list. These first four instruments that are displayed may or may not be the four instruments that are currently communicating with the 3M Molecular Detection Software.

Naming instruments

Only administrator level users can edit instruments.
1. Click Administration on the menu bar, and then select Instruments….
2. The Instrument tab on the Administration window displays all instruments that have been automatically detected
3. Click the instrument you want to rename.
4. Enter a name into the Name field. The instrument name can be any free-format text. You cannot change the instrument serial number.
5. Click the [Apply] button to apply the name, or click the [OK] button to apply the name and return to the Start Page window.

Hiding instruments

Only administrator level users can hide instruments. You should hide instruments that are no longer used by the 3M Molecular Detection Software, but that have been used for at least one run in the past. Hiding an instrument removes the instrument name from the instrument name list while leaving the instrument in the database. This allows management of active instruments while maintaining the integrity of historical data.
1. Click Administration on the menu bar, and then select Instruments….
2. The Instrument tab on the Administration window displays all instruments that have been automatically detected.
3. Click the instrument you want to hide.
4. Click the [Hide] button to hide the instrument.
5. Click the [Apply] button to apply the change, or click the [OK] button to apply the change and return to the Start Page window.

Changing the order of instruments

Only administrator level users can change the sequence of instruments.
1. Click Administration on the menu bar, and then select Instruments….
2. The Instrument tab on the Administration window displays all instruments that have been automatically detected.
3. Click the instrument you want to move to a different position in the list.
4. Click the [Up] button to move the selected instrument one position closer to the top of the list, or click the [Down] button to move the selected instrument one position closer to the bottom of the list.
5. Click the [Apply] button to apply the change, or click the [OK] button to apply the change and return to the Start Page window.
6. The instrument status bar displays only the first four connected instruments in the instruments tab.

Deleting instruments

Only administrator level users can delete instruments.
1. Click Administration on the menu bar, and then select Instruments….
2. The Instrument tab on the Administration window displays all instruments that have been automatically detected.
3. Click the instrument you want to delete from the list. You cannot delete an instrument that is active, or an instrument that has been used for at least one run in the past.
4. Click the [Delete] button.
5. Click the [Apply] button to apply the deletion, or click the [OK] button to apply the deletion and return to the Start Page window.
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Viewing instruments

Any level user can view users.
1. Click Administration on the menu bar, and then select Instruments….
2. The Instrument tab on the Administration window displays all instruments that have been automatically detected. Show all hidden instruments by clicking the Show hidden checkbox. The instrument status bar displays only the first four connected instruments in the instruments tab.
Configuring Fields
Only administrator level users can configure fields.
1. The 3M Molecular Detection Software provides seven user-definable sample fields. You define the seven sample fields (column headers) during the installation of the software.
• You cannot change the Field Names or the Field Types after you define them during the installation.
• You can change the Field Type List values and the Enable checkboxes after installation.
2. Click Administration on the menu bar, and then select Configure Fields….
3. The Configure Fields tab displays the current Field Names, Field Types and a checkbox for enabling the field.
4. You can add a new value to a List Field Type:
a. Click the symbol next to the drop down selector. b. Enter the new value for the list as shown in Figure 21. The new value can be any free-format text.
c. Press the [Enter] key r click the symbol. d. Click the [Apply] button to apply the addition, or click the [OK] button to apply the addition and return to the Start
Page window.
5. You cannot delete a value from a List Field Type.
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6. You can enable a Field Name to make it appear on the Sample tab in the Setup window or you can disable a Field Name to prevent if from appearing on the Sample tab in the Setup window.
a. To enable or disable a Field Name, simply click the check box in the Enabled column. ( ) b. Click the [Apply] button to apply the change, or click the [OK] button to apply the change and return to the Start
Page window.
7. An example of configuring a field is shown below. In this example, the value “Another Sample Type” is added to the Sample Type dropdown list. Notice that the fields that are not enabled in are hidden in the Samples wndow in.
Adding a New Value to a List
New Sample Type and Disabled Fields
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