Qiagen QIAcube Connect MDx User manual

Sample to Insight__
December 2020
QIAcube® Connect
MDx User Manual
The QIAcube Connect MDx is intended for in vitro diagnostic use.
9003070
QIAGEN GmbH, QIAGEN Strasse 1, D
-40724 Hilden
R1
11
21932

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Contents
1Introduction .............................................................................................................6
1.1 About this user manual ...............................................................................6
1.1.1 Technical assistance ................................................................................6
1.1.2 Policy statement .....................................................................................7
1.2 Intended use of the QIAcube Connect MDx ....................................................7
1.3 Requirements for QIAcube Connect MDx users ...............................................7
1.4 Glossary....................................................................................................8
1.5 Accessories ................................................................................................8
2Safety Information....................................................................................................9
2.1 Proper use .................................................................................................9
2.2 Electrical safety ........................................................................................11
2.3 Environment.............................................................................................12
2.4 Biological safety .......................................................................................13
2.5 Chemicals ................................................................................................14
2.6 Waste disposal.........................................................................................15
2.7 Mechanical hazards..................................................................................15
2.7.1 Centrifuge............................................................................................16
2.8 Heat hazard ............................................................................................17
2.9 Maintenance safety...................................................................................17
2.10 Radiation safety .......................................................................................19
2.11 Symbols on the QIAcube Connect MDx........................................................20
3General Description................................................................................................21
3.1 QIAcube Connect MDx principle .................................................................22
3.2 External features of the QIAcube Connect MDx.............................................24
3.3 Internal features of the QIAcube Connect MDx .............................................29
3.4 Disposables .............................................................................................36
4Installation Procedures ............................................................................................38
4.1 Installation environment ............................................................................38
4.1.1Site requirements..................................................................................38

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4.1.2 Power requirements ..............................................................................39
4.1.3 Grounding requirements........................................................................40
4.2 Unpacking the QIAcube Connect MDx .........................................................40
4.3 Installing the QIAcube Connect MDx ...........................................................41
4.3.1 Removal of the QIAcube Connect MDx accessories and shipping material....41
4.3.2 Installation of AC power cord.................................................................42
4.3.3 Installation of external barcode scanner ..................................................43
4.3.4 Installing the centrifuge rotor and buckets................................................43
4.3.5 Installing the shaker adapter..................................................................44
4.4 Configuration of the QIAcube Connect MDx .................................................45
4.4.1 System configurations ...........................................................................46
4.4.2 Settings configuration............................................................................48
4.4.3 Network configuration ..........................................................................49
4.5 Packaging and transporting of the QIAcube Connect MDx .............................53
5Operating Procedures .............................................................................................55
5.1 QIAcube Connect MDx software .................................................................58
5.2 Switching the QIAcube Connect MDx on and off...........................................61
5.3 Logging in and Logging out .......................................................................62
5.4 Setting up a protocol run ...........................................................................63
5.4.1 Material selection .................................................................................67
5.4.2 Protocol selection..................................................................................68
5.4.3 Parameter definition .............................................................................69
5.4.4 Sample number definition......................................................................70
5.4.5 Loading buffer bottles ...........................................................................70
5.4.6 Loading tips and enzymes .....................................................................73
5.4.7 Loading the centrifuge...........................................................................75
5.4.8 Loading the shaker ...............................................................................82
5.5 Starting a protocol run ..............................................................................85
5.6 Stopping a protocol run.............................................................................87
5.7 Saving run reports to the USB flash drive.....................................................88
5.8 Low space on flash memory.......................................................................90

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5.9 Independent heater/shaker operation .........................................................90
5.10 Independent centrifuge operation ...............................................................92
5.11 Managing protocols..................................................................................95
5.11.1 Installing new protocols.........................................................................95
5.11.2 Deleting all protocols.............................................................................96
5.11.3 Saving protocols...................................................................................97
5.12 Updating software....................................................................................98
5.13 User Management ..................................................................................100
5.13.1 Setting up a new user .........................................................................101
5.13.2 Changing data for an existing user .......................................................103
5.13.3 Deleting or temporarily deactivating a user............................................104
5.13.4 Changing password............................................................................105
6Cleaning and Maintenance....................................................................................107
6.1 Cleaning agents .....................................................................................108
6.2 Disinfection ............................................................................................108
6.3 Regular maintenance ..............................................................................111
6.4 Daily maintenance..................................................................................111
6.5 Monthly maintenance..............................................................................113
6.6 Periodic maintenance ..............................................................................114
6.6.1 Cleaning the robotic arm modules.........................................................114
6.6.2 Cleaning the centrifuge........................................................................115
6.6.3 Operating the centrifuge after cleaning .................................................120
6.7 Optional Maintenance.............................................................................121
6.7.1 UV run ..............................................................................................121
6.7.2 Tightness test......................................................................................123
6.8 Decontaminating the QIAcube Connect MDx ..............................................124
6.9 Servicing ...............................................................................................124
7Troubleshooting ...................................................................................................125
7.1 Contacting QIAGEN Technical Services ......................................................125
7.2 Creating a support package.....................................................................125
7.3 Operation..............................................................................................126

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7.3.1 Protocol interruption ...........................................................................129
7.3.2Centrifuge..........................................................................................129
7.3.3 Reagent volume detection and ultrasonic pipe ........................................131
7.3.4 Touchscreen .......................................................................................132
7.3.5 O-Ring exchange................................................................................134
8Glossary .............................................................................................................140
9Appendix A – Technical data .................................................................................142
9.1 Operating conditions...............................................................................142
9.2 Transport conditions................................................................................142
9.3 Storage conditions ..................................................................................142
9.4 Mechanical data and hardware features ...................................................143
9.5 Declaration of Conformity........................................................................144
9.6 Waste Electrical and Electronic Equipment (WEEE) .......................................144
9.7 EMC Declaration.....................................................................................145
9.8 Liability Clause .......................................................................................146
10 Appendix B – QIAcube Connect MDx Accessories.....................................................148
11 Version history.....................................................................................................151
Index 152

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1Introduction
Thank you for choosing the QIAcube Connect MDx. We are confident it will become an integral
part of your laboratory. Before using the QIAcube Connect MDx, it is essential that you read this
user manual carefully and pay attention to the safety information. The instructions and safety
information in the user manual must be followed to ensure safe operation of the instrument and to
maintain the instrument in a safe condition.
1.1 About this user manual
This user manual provides information about the QIAcube Connect MDx in the following sections:
1. Introduction
2. Safety Information
3. General Description
4. Installation Procedures
5. Operating Procedures
6. Cleaning and Maintenance
7. Troubleshooting
8. Glossary
9. Appendix A – Technical data
10.Appendix B – QIAcube Connect MDx Accessories
11.Version history
1.1.1 Technical assistance
At QIAGEN®, we pride ourselves on the quality and availability of our technical support. Our
Technical Services Departments are staffed by experienced scientists with extensive practical and
theoretical expertise in molecular biology and the use of QIAGEN products. If you have any
questions or experience any difficulties regarding the QIAcube Connect MDx or QIAGEN products
in general, 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.

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For technical assistance and more information, please see our Technical Support Center at
www.qiagen.com/support/technical-support or call one of the QIAGEN Technical Service
Departments or local distributors (see back cover or visit www.qiagen.com).
For up-to-date information about QIAcube Connect MDx instrument, visit
https://www.qiagen.com/products/qiacube-connect-mdx.
1.1.2 Policy statement
It is the policy of QIAGEN to improve products as new techniques and components become
available. QIAGEN reserves the right to change specifications at any time.
To produce useful and appropriate documentation, we appreciate your comments on this user
manual. Please contact QIAGEN Technical Services.
1.2 Intended use of the QIAcube Connect MDx
QIAcube Connect MDx is designed to perform automated isolation and purification of nucleic acids
in molecular diagnostic and/or molecular biology applications. The system is intended for use by
professional users, such as technicians and physicians trained in molecular biological techniques
and the operation of the QIAcube Connect MDx system.
The QIAcube Connect MDx is intended to be used only in combination with QIAGEN and PAXgene
kits indicated for use with the QIAcube Connect MDx for the applications that will be described in
the kit handbooks.
1.3 Requirements for QIAcube Connect MDx users
The table below covers the general level of competence and training necessary for transportation,
installation, use, maintenance, and servicing of the QIAcube Connect MDx.
Task Personnel Training and experience
Delivery No special requirements No special requirements
Installation, routine use and
maintenance
Laboratory technicians or equivalent Appropriately trained and
experienced personnel familiar
with use of computers and
automation in general
Servicing and annual maintenance QIAGEN Field Service Specialists only Trained and authorized by
QIAGEN

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1.4 Glossary
For a glossary of terms used in this User Manual, refer to Section 8.
1.5 Accessories
For information about QIAcube Connect MDx accessories, refer to Appendix B of this User Manual.

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2Safety Information
Before using the QIAcube Connect MDx, it is essential that you read this user manual carefully and
pay attention to the safety information. The instructions and safety information in the user manual
must be followed to ensure safe operation of the instrument and to maintain the instrument in a safe
condition.
Possible hazards that could harm the user or result in damage to the instrument are clearly stated
at the appropriate places throughout this consolidated operating guide.
If the equipment is used in a manner not specified by the manufacturer, the protection provided by
the equipment may be impaired.
The following safety conventions appear throughout this manual:
WARNING
The term WARNING is used to inform you about situations that could result
in personal injury to you or other persons.
Details about these circumstances are given in a box like this one.
CAUTION
The term CAUTION is used to inform you about situations that could result in
damage to the instrument or other equipment.
Details about these circumstances are given in a box like this one.
The advice given in this manual is intended to supplement, not supersede, the normal safety
requirements prevailing in the user’s country.
2.1 Proper use
WARNING
Risk of personal injury and material damage [W1]
Improper use of the QIAcube Connect MDx may cause personal injuries or
damage to the instrument. The QIAcube Connect MDx must only be
operated by qualified personnel who have been appropriately trained.
Servicing of the QIAcube Connect MDx must only be performed by a
QIAGEN Field Service specialist.
Perform the maintenance as described in section 6, Maintenance Procedures. QIAGEN charges for
repairs that are required due to incorrect maintenance.

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WARNING Risk of personal injury and material damage [W2]
The QIAcube Connect MDx is too heavy to be lifted by one person. To
avoid personal injury or damage to the instrument, do not lift the instrument
alone.
WARNING Risk of personal injury and material damage [W3]
Do not attempt to move the QIAcube Connect MDx during operation.
CAUTION
Damage to the instrument [C1]
Avoid spilling water or chemicals onto the QIAcube Connect MDx. Damage
caused by water or chemical spillage will void your warranty.
In case of emergency, power OFF the QIAcube Connect MDx at the power switch located in front
of the instrument and unplug the power cord from the power outlet.
CAUTION Damage to the instrument [C2]
Only use QIAGEN spin columns and QIAcube Connect MDx specific
consumables with the QIAcube Connect MDx. Damage caused by use of
other types of spin columns or chemistries will void your warranty.
WARNING
Risk of personal injury and material damage [W4]
Do not use damaged rotor adapters. The rotor adapters can only be used
once. High g forces exerted in the centrifuge can cause damage to re-used
rotor adapters.
CAUTION
Damage to the instrument [C3]
Empty the tip disposal container prior to use to prevent a tip jam in the waste
drawer. Failure to empty the waste container may block the robotic arm that
could cause run failure or instrument damage.
WARNING
Risk of personal injury and material damage [W5]
To prevent plastic crash, load the tubes properly. After a plastic crash, sharp
plastic particles could be inside the centrifuge. Be careful when handling
items inside the centrifuge.
CAUTION
Damage to the instrument [C4]
Only use the correct volume of liquids.
Exceeding the recommended volume of liquids may damage the centrifuge
rotor or instrument.