Qiagen Rotor-Gene Q MDx User manual

October 2018
Sample & Assay Technologies
Rotor-Gene®Q MDx
Installation Guide (US)
For use with Rotor-Gene Q Software version 2.3.4 or higher
QIAGEN GmbH, QIAGEN Strasse 1, 40724 Hilden, GERMANY

QIAGEN Sample and Assay Technologies
QIAGEN is the leading provider of innovative sample and assay technologies,
enabling the isolation and detection of contents of any biological sample. Our
advanced, high-quality products and services ensure success from sample to
result.
QIAGEN sets standards in:
Purification of DNA, RNA, and proteins
Nucleic acid and protein assays
microRNA research and RNAi
Automation of sample and assay technologies
Our mission is to enable you to achieve outstanding success and
breakthroughs. For more information, visit www.qiagen.com.

Rotor-Gene Q MDx Installation Guide (US) 10/2018 3
Contents
Product Warranty and Satisfaction Guarantee 4
Technical Assistance 4
Introduction 5
About this installation guide 5
Unpacking the Rotor-Gene Q MDx 6
Hardware Installation 7
Installing Rotor-Gene Q Software 7
Connecting the Laptop/Computer to the Rotor-Gene Q MDx 9
USB connection for Rotor-Gene Q software and Rotor-Gene AssayManager 9
RS-232 connection for Rotor-Gene Q software 11
Launching Rotor-Gene Q Software 12
Rotor-Gene Q Software Assay Packages 12
Launching Rotor-Gene AssayManager 12
Rotor-Gene AssayManager Assay Profiles and Plug-ins 13
Configuration for Windows 7 security 13
Additional Software on Computers Connected to Rotor-Gene Q MDx
Instruments 14
Antivirus software 15
System tools 19
Operating system updates 19
Updating Rotor-Gene Q Software and Rotor-Gene AssayManager
Software 22

4Rotor-Gene Q MDx Installation Guide (US) 10/2018
Product Warranty and Satisfaction Guarantee
QIAGEN guarantees the performance of all products in the manner described
in our product literature. The purchaser must determine the suitability of the
product for its particular use. Should any product fail to perform satisfactorily
due to any reason other than misuse, QIAGEN will replace it free of charge or
refund the purchase price. We reserve the right to change, alter, or modify any
product to enhance its performance and design. If a QIAGEN product does not
meet your expectations, simply call your local Technical Service department or
distributor. We will credit your account or exchange the product — as you wish.
Separate conditions apply to QIAGEN scientific instruments, service products,
and to products shipped on dry ice. Please inquire for more information.
A copy of QIAGEN terms and conditions can be obtained on request, and is
also provided on the back of our invoices. If you have questions about product
specifications or performance, please call QIAGEN Technical Services (see back
cover or visit www.qiagen.com) or your local distributor.
Technical Assistance
At QIAGEN, we pride ourselves on the quality and availability of our technical
support. Our Technical Service departments are staffed by experienced scientists
with extensive practical and theoretical expertise in sample and assay
technologies and the use of QIAGEN products. If you have any questions or
experience any difficulties regarding Rotor-Gene Q MDx instruments or
QIAGEN products in general, please do not hesitate to contact us.
QIAGEN customers are a major source of information regarding advanced or
specialized uses of our products. This information is helpful to other scientists as
well as to the researchers at QIAGEN. We therefore encourage you to contact
us if you have any suggestions about product performance or new applications
and techniques.
For technical assistance and more information, please see our Technical
Support Center at www.qiagen.com/Support or call one of the QIAGEN
Technical Service departments or local distributors (see back cover or visit
www.qiagen.com).

Rotor-Gene Q MDx Installation Guide (US) 10/2018 5
Introduction
About this installation guide
This guide provides an overview for installing Rotor-Gene Q MDx instruments.
Note: Please consult the
Rotor-Gene Q MDx User Manual (US) for additional
details regarding installation, such as site and AC power requirements. Pay
particular attention to the safety information.
Information about Rotor-Gene Q MDx instruments is provided in the following
sections:
Unpacking the Rotor-Gene Q MDx
Hardware Installation
Installing Rotor-Gene Q Software
Connecting the Laptop/Computer to the Rotor-Gene Q MDx
Launching Rotor-Gene Q Software
Rotor-Gene Q Software Assay Packages
Launching Rotor-Gene AssayManager®
Rotor-Gene AssayManager Assay Profiles and Plug-ins
Additional Software on Computers Connected to Rotor-Gene Q MDx
Instruments
Updating Rotor-Gene Q Software and Rotor-Gene AssayManager Software

6Rotor-Gene Q MDx Installation Guide (US) 10/2018
Unpacking the Rotor-Gene Q MDx
The Rotor-Gene Q MDx is delivered with all necessary accessories for
instrument setup and for performing a run. A list of accessories is provided in
the Rotor-Gene Q MDx box.
Note: Check the items on this list to ensure that all accessories are present.
Note: Check that the instrument and delivered accessories are free from
transport damage before installation.
The accessories box is on top of the foam packing. The accessories box
contains:
 Rotor-Gene Q MDx Installation Guide (US)
CD (Rotor-Gene Q software)
CD ( Rotor-Gene Q MDx User Manual [US] )
CD ( Rotor-Gene Q User Manual )
Loading Block 96 x 0.2 ml Tubes*
* Not intended for use with FDA cleared or approved nucleic acid tests
Loading Block 72 x 0.1 ml Tubes
Rotor Holder (dismantled for safe transport)
36-Well Rotor (this rotor is red in color)*
* Not intended for use with FDA cleared or approved nucleic acid tests
36-Well Rotor Locking Ring*
* Not intended for use with FDA cleared or approved nucleic acid tests
The following items are packed on each side of the foam packing:
USB and RS-232 serial cable
International power cable set
PCR Tubes, 0.2 ml (1000)*
* Not intended for use with FDA cleared or approved nucleic acid tests
Strip Tubes and Caps, 0.1 ml (1000)
Once all these components have been removed from the box, remove the foam
packing on top of the Rotor-Gene Q MDx. Carefully remove the Rotor-Gene Q
MDx from the box and unwrap the plastic cover. Open the lid by sliding it
towards the back to access the reaction chamber.
The following items are already installed inside the Rotor-Gene Q MDx:
72-Well Rotor (this rotor is blue in color)
72-Well Rotor Locking Ring

Rotor-Gene Q MDx Installation Guide (US) 10/2018 7
A laptop computer is included with your Rotor-Gene Q MDx instrument.
Rotor-Gene AssayManager software is supplied on a separate installation DVD
upon ordering.
Once you have unpacked the Rotor-Gene Q MDx, proceed with instrument
hardware installation as described below.
Hardware Installation
Note: When the Rotor-Gene Q MDx is started immediately after delivery in cold
climates, mechanical parts can stall. Allow the instrument to acclimatize to room
temperature for at least one hour before turning the instrument on.
1. Place the Rotor-Gene Q MDx on a level surface that is vibration free.
Note: Ensure that there is sufficient space behind the instrument for the lid
to open fully.
Note: Ensure that the power switch at the back of the instrument can be
easily reached.
Note: Do not obstruct the back of the instrument. Ensure that the power
cord can be easily detached if required, to disconnect power to the
instrument.
2. Install Rotor-Gene Q software and Rotor-Gene AssayManager, if
applicable.
Install the Rotor-Gene Q software and connect the computer/laptop and
instrument as described below.
Install Rotor-Gene AssayManager and plug-ins as described in the
“Rotor-Gene AssayManager Core Application User Manual (US) IVD” in
Part II of Volume 2 of the
QIAsymphony RGQ MDx (US) User Manual .
Installing Rotor-Gene Q Software
The Rotor-Gene Q MDx can be connected to a computer either via a USB
interface (recommended) or via an RS-232 serial interface. Rotor-Gene Q
software should be installed as described below before connecting the laptop
computer to the Rotor-Gene Q MDx.
The Rotor-Gene Q software can be downloaded from the QIAGEN website and
transferred to a virus-free removable storage (USB storage) and then
transferred to the computer connected to the Rotor-Gene Q.
1. Insert the Installation CD or removable storage into the computer.
The software should launch automatically if using the CD-ROM. If it
does not, browse to the CD-ROM in Windows®Explorer and double-
click “autorun.hta”. If using another form of removable storage,
navigate to the device using Windows explorer and double-click the
Rotor-Gene Q “.exe” file.

8Rotor-Gene Q MDx Installation Guide (US) 10/2018
2. Install the Rotor-Gene Q software by clicking “Install Operating
Software” in the window that appears.
3. Click “Next”, then select “I accept the agreement” in the license
agreement step, and click “Next” again.
4. In the “Region” window, select the region that will be used by the
software to direct support requests to the right location.
5. Select the destination location where the Rotor-Gene Q software
should be installed. For convenience, simply accept the suggested
destination folder by clicking “Next”.
6. In the “Select Components” window you can select “Standard
Installation” or “Force authentication through Windows domain
(advanced users only)” via a drop-down list. Select “Force
authentication through Windows domain (advanced users only)” if
you want to use the advanced security features (see section on
“Access Protection” in the
Rotor-Gene Q MDx User Manual (US) for

Rotor-Gene Q MDx Installation Guide (US) 10/2018 9
more details). With this selection, the checkbox “Security & User
Management” is automatically activated. Then click “Next”.
7. The setup wizard will now install the Rotor-Gene Q software. If the
following message appears, click “Continue Anyway”.
8. After installation is completed, close the setup wizard by clicking
“Finish”.
Connecting the Laptop/Computer to the
Rotor-Gene Q MDx
USB connection for Rotor-Gene Q software and
Rotor-Gene AssayManager
We recommend connecting the laptop computer, which was delivered with your
Rotor-Gene Q MDx, via the USB port.

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1. Connect one end of the provided USB cable to a USB port at the back
of the computer. Connect the other end of the USB cable to the back
of the Rotor-Gene Q MDx. Then connect the Rotor-Gene Q MDx to
the power supply.
2. Switch on the Rotor-Gene Q MDx.
3. The following window appears. Select “No, not this time” and then
click “Next”.
4. Select “Install the software automatically (Recommended)” and then
click “Next”.

Rotor-Gene Q MDx Installation Guide (US) 10/2018 11
5. Click “Continue Anyway”.
6. Click “Finish”.
7. Click “Yes” to restart the computer.
8. After the computer has restarted, log in again and launch the Rotor-
Gene Q software as described below.
RS-232 connection for Rotor-Gene Q software
1. Connect one end of the provided RS-232 serial cable to the serial
port of your computer. Connect the other end of the RS-232 serial
cable to the back of the Rotor-Gene Q MDx. Then connect the Rotor-
Gene Q MDx to the power supply.
2. Switch on the Rotor-Gene Q MDx.
3. Start the Rotor-Gene Q software and launch the Rotor-Gene Q
software as described below.

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Launching Rotor-Gene Q Software
1. Double-click the “Rotor-Gene Q Series software” desktop icon to
launch the software. A message may appear with information. Click
“Yes” to view a list of the latest changes or “No” to continue with the
Rotor-Gene Q installation.
2. A “Welcome” window appears the first time the software is
launched, but it does not appear for subsequent software upgrades.
3. Enter the serial number using numerical digits only (e.g., 0110123).
You can find the serial number on the type plate located at the back
of the instrument.
4. Click “Auto-Detect”. The corresponding USB or serial port will be
detected and shown in the “Port” drop-down list.
5. Click “Begin” to work with the software.
6. Exit the Rotor-Gene Q software to install and work with Rotor-Gene
assay packages.
Rotor-Gene Q Software Assay Packages
Rotor-Gene Q software assay packages contain the required files to run and
analyze individual types of assays. A separate software installation is required
for each assay package. The installation copies the required files to the system
and creates one or more shortcuts on the desktop. The installation and use of
each specific assay package is described in detail in the corresponding
Instructions for Use (Handbook) for the assay you are using.
Launching Rotor-Gene AssayManager
To launch Rotor-Gene AssayManager, see the “Rotor-Gene AssayManager
Core Application User Manual (US) IVD”
in Part II of Volume 2 of the
QIAsymphony RGQ MDx (US) User Manual .

Rotor-Gene Q MDx Installation Guide (US) 10/2018 13
Rotor-Gene AssayManager Assay Profiles and
Plug-ins
For more information on Rotor-Gene AssayManager assay profiles and
plug-ins, see the “Rotor-Gene AssayManager Core Application User Manual
(US) IVD”
in Part II of Volume 2 of the QIAsymphony RGQ MDx (US) User
Manual
.
Configuration for Windows 7 security
The laptop computers that are provided by QIAGEN for use with your Rotor-
Gene Q MDx instrument have Microsoft®Windows 7 preinstalled and are
configured with a standard (nonadministrative) Windows user account and with
an administrator account. In routine usage of the system, the standard account
shall be used, since Rotor-Gene Q software and the Rotor-Gene AssayManager
version 1.0 or 2.1 are designed to run without administrator rights. The
administrator account – the one with the red desktop background – shall only
be used to install the Rotor-Gene Q or the Rotor-Gene AssayManager version
1.0 or 2.1 software and an antivirus software (please see section on “Antivirus
software”). Using the administrator account is indicated by a red desktop
background. Please make sure, that you always log in as standard user for
routine use.
Q1a#g3n!A6 is the default password of the administrator account. Please
change the administrator password after first login. Please make sure that the
password is secure and does not get lost. There is no password for the operator
account.
If the laptop Administrator password is lost, then we would advise you to contact
Microsoft for support.
If your configuration is different and no nonadministrative account is contained,
system administrators shall set up an additional standard Windows user account
to prevent access to critical system areas such as Program Files, Windows
directory (e.g., access to installation or uninstallation functionality, including
applications, operating system components, date/time settings, Windows
updates, firewall, user rights and roles, antivirus activation), or performance-
relevant settings like power saving.
To create a standard user account in Windows 7, please follow these steps
described in section “Creating a new user account”.

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Open the Windows control panel via the Start menu and select “User
Accounts” and then “Manage Accounts”.
1. Choose “Create a new account”.
2. Name the account and select “Standard User” as the account type.
3. Click “Create Account”.
Additional Software on Computers Connected to
Rotor-Gene Q MDx Instruments
Rotor-Gene Q software manages time-critical processes during the PCR run and
the data acquisition process. For this reason, it is important to ensure that no
other processes use significant system resources and thus slow down the
Rotor-Gene Q software. It is particularly important to pay attention to the points
listed below.
System administrators are advised to consider any impact that a modification to
the system may have on the resources before implementing it.

Rotor-Gene Q MDx Installation Guide (US) 10/2018 15
Antivirus software
QIAGEN is aware of the threat that computer viruses pose to any computer that
exchanges data with other computers. Rotor-Gene AssayManager version 1.0
or 2.1 software is expected to be primarily installed in environments where local
policies are in place to minimize this threat. However, QIAGEN recommends
the use of antivirus software in any case. The selection and installation of an
appropriate antivirus software is in the customer’s responsibility. However,
QIAGEN has validated the Rotor-Gene Q software and Rotor-Gene
AssayManager versions 1.0 and 2.1 with the QIAGEN laptop in combination
with the following two antivirus software to show compatibility:
Symantec®Endpoint Protection V12.1.6
Microsoft Security Essentials V4.10.2091
Please refer to the product page on QIAGEN.com for the latest versions of
antivirus software that have been validated in combination with the Rotor-Gene
Q software and Rotor-Gene AssayManager version 1.0 or 2.1.
If an antivirus software is selected, make sure that it can be configured in a way
that the database folder path can be excluded from the scan. Otherwise, there
is the risk of database connection errors. Since Rotor-Gene AssayManager
versions 1.0 and 2.1 create new database archives dynamically, it is required to
exclude the
folder path to the files and not the single files. We do not
recommend the use of antivirus software where only single files can be
excluded, e.g. McAfee Antivirus Plus V16.0.5. If the computer is used in an
environment without network access, please also make sure that the antivirus
software supports offline updates.
To get consistent results after installation of an antivirus software, a system
administrator should ensure the following:
As explained above, the database folder path of the Rotor-Gene
AssayManager 1.0 and 2.1 (C:\Program Files\Microsoft SQL
Server\MSSQL10_50.RGAMINSTANCE\MSSQL\DATA) needs to be
excluded from file scans.
Updates to the virus database are not performed when the Rotor-Gene
AssayManager 1.0 or 2.1 is in use.
All full or partial scans of the hard drive are disabled during real-time PCR
data acquisition. Otherwise, there is a risk of adverse impact on the
performance of the instrument.
Please read the manual of your selected antivirus software for configuration
details.
1Note: After installation of “Microsoft Security Essentials”, you shall check that Windows
updates are deactivated since the installation might activate this setting (please read chapter
“Operating system updates”).

16 Rotor-Gene Q MDx Installation Guide (US) 10/2018
Firewall and networks
The Rotor-Gene Q software can run either on computers without network access
or in a network environment if a remote database server is used. For networked
operation, the firewall on the laptop computer provided by QIAGEN is
configured in a way that inbound traffic is blocked for all ports except those
required to establish a network connection.
Please note that blocking incoming connections does not affect responses to
requests triggered by the user. Outgoing connections are allowed because they
may be required for retrieving updates.
If your configuration is different, QIAGEN recommends to configure the firewall
in the same way as described above. To this end, a system administrator must
log in and perform the following steps:
1. Open the Control Panel and select “Windows Firewall”.
2. Select “Use recommended settings”.

Rotor-Gene Q MDx Installation Guide (US) 10/2018 17
3. Check that the following settings are active:
For security and reliability reasons, cable-based network access instead of Wi-Fi
shall be used. The laptop computers that are provided by QIAGEN have a
disabled Wi-Fi adapter. If your configuration is different, a system administrator
must disable the Wi-Fi adapter manually. This can be done through the
following steps:
1. Open the Control Panel and select “Network and Sharing Center”.

18 Rotor-Gene Q MDx Installation Guide (US) 10/2018
2. Select “Change adapter settings”.
3. Hover over “Wireless Network Connection”, press the right mouse
button, and select “Disable” from the context menu.

Rotor-Gene Q MDx Installation Guide (US) 10/2018 19
4. Check that “Wireless Network Connection” is disabled.
System tools
Many system tools may use significant system resources even without any user
interaction. Typical examples of such tools are:
File indexing, which is performed as a background task by many
contemporary office applications
Disk defragmentation, which often also employs a background task
Any software that checks for updates on the internet
Remote monitoring and management tools
Note: Due to the dynamic nature of information technology products and
systems, this list may be incomplete. Tools may be released that are not known
at the time of writing. It is important that system administrators take care that
such tools are not active on the Rotor-Gene Q MDx during a PCR run.
Operating system updates
The laptop computers provided by QIAGEN are configured such that automatic
updates of the operating system are disabled. If your configuration is different,
a system administrator must disable any automatic update process of the
operating system. This can be done through the following steps:

20 Rotor-Gene Q MDx Installation Guide (US) 10/2018
1. Open the Control Panel and select “Windows Update”.
2. Select “Change settings”.