Qiagen EZ2 Connect User manual

Sample to Insight__
May 2022
EZ2®Connect MDx
User Manual
The EZ2 Connect MDx is intended for in vitro diagnostic use.
9003230
QIAGEN GmbH
QIAGEN Strasse 1, 40724 Hilden
, GERMANY
1124548

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Contents
1Introduction .............................................................................................................6
1.1 About this user manual....................................................................................6
1.2 General information........................................................................................7
1.2.1 Technical assistance................................................................................7
1.2.2 Policy statement......................................................................................7
1.3 Intended use of the EZ2 Connect MDx ..............................................................8
1.4 Requirements for EZ2 users..............................................................................8
1.5 Materials required ..........................................................................................8
1.6 Materials required but not provided..................................................................9
1.7 Glossary........................................................................................................9
1.8 Accessories....................................................................................................9
2Safety Information ..................................................................................................10
2.1 Proper use ...................................................................................................11
2.2 Electrical safety ............................................................................................13
2.3 Operating conditions ....................................................................................15
2.4 Biological safety...........................................................................................16
2.5 Chemicals....................................................................................................18
2.6 Waste disposal ............................................................................................19
2.7 Mechanical hazards .....................................................................................19
2.8 Heat hazard ................................................................................................20
2.9 Radiation.....................................................................................................20
2.10 Maintenance safety ..................................................................................21
2.11 Symbols on the EZ2 Connect MDx instrument ..............................................23
3General Description ...............................................................................................25
3.1 Principle ......................................................................................................25
3.2 External features of the EZ2 Connect MDx.......................................................26
3.2.1 Touchscreen.........................................................................................28
3.2.2 Hood ..................................................................................................29
3.2.3 Power button........................................................................................30

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3.2.4 USB ports ............................................................................................30
3.2.5 RJ-45 Ethernet port................................................................................32
3.2.6 Power cord socket ................................................................................33
3.2.7 Ventilation openings .............................................................................34
3.2.8 Bar code scanner .................................................................................34
3.3 Internal features of the EZ2 ............................................................................35
3.3.1 Pipettor head .......................................................................................35
3.3.2 Worktable ...........................................................................................37
3.3.3 Magnet module....................................................................................41
3.3.4 Camera...............................................................................................42
3.3.5 UV LED lamp........................................................................................42
3.3.6 Internal light.........................................................................................43
4Installation Procedures ............................................................................................44
4.1 Installation environment.................................................................................44
4.1.1 Site requirements..................................................................................44
4.1.2 Power requirements ..............................................................................45
4.1.3 Grounding requirements........................................................................46
4.2 Unpacking the EZ2.......................................................................................47
4.3 Installing the EZ2 Connect MDx .....................................................................49
4.3.1 Removal of the EZ2 accessories and shipping materials ............................50
4.3.2 Installation of the AC power cord ...........................................................50
4.3.3 Installation of external barcode scanner ..................................................51
4.3.4 Installation of Wi-Fi adapter (optional) ....................................................52
4.3.5 Initial configuration of the EZ2 ...............................................................52
4.3.6 Performing camera exposure calibration .................................................54
4.4 Packaging and Transportation of the EZ2 Connect MDx....................................56
5Operating Procedures.............................................................................................57
5.1 General information......................................................................................60
5.1.1Entering text and numbers .....................................................................62
5.2 Starting the EZ2 ...........................................................................................65
5.3 Configuring the EZ2 .....................................................................................67

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5.3.1Setting basic system data ......................................................................67
5.3.2 Changing Instrument settings..................................................................68
5.3.3 Managing users ...................................................................................69
5.3.4 Changing password .............................................................................75
5.3.5Managing user security.........................................................................77
5.3.6 Installing new protocols.........................................................................78
5.3.7 Language Settings ................................................................................80
5.3.8Updating software ................................................................................82
5.3.9 Configuring network and QIAsphere Base connections .............................84
5.4 Setting up a protocol run ............................................................................ 100
5.4.1 Scanning Q-Card bar code ................................................................ 102
5.4.2 Defining parameters .......................................................................... 104
5.4.3 Selecting sample positions.................................................................. 105
5.4.4 Entering sample IDs ........................................................................... 106
5.4.5 Loading the cartridge rack.................................................................. 109
5.4.6 Loading the tip rack ........................................................................... 110
5.4.7 LIMS Workflow ................................................................................. 112
5.5 Canceling the protocol run setup ................................................................. 118
5.6 Starting the protocol run and monitoring its progress ..................................... 118
5.6.1 Load check ....................................................................................... 121
5.7 End of the protocol run............................................................................... 126
5.8 Aborting a protocol run.............................................................................. 127
5.9 Saving a run report.................................................................................... 128
5.9.1Run report contents ............................................................................ 128
5.10 Setting up the worktable......................................................................... 129
5.10.1 Loading and unloading the cartridge rack ............................................ 130
5.10.2 Loading and unloading the tip rack ..................................................... 131
5.11 Using the bar code scanner .................................................................... 132
5.12 Data menu............................................................................................ 133
Run reports.................................................................................................... 134
Support package ........................................................................................... 137

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Audit trail...................................................................................................... 137
5.13 Logging out and switching the instrument off............................................. 138
5.14 Research mode ..................................................................................... 139
6Maintenance Procedures...................................................................................... 141
6.1Cleaning agents........................................................................................ 142
6.1.1 Disinfecting the EZ2........................................................................... 144
6.1.2 Removing contamination .................................................................... 144
6.2 After run maintenance................................................................................ 145
6.3 Daily maintenance..................................................................................... 148
6.4 Weekly maintenance ................................................................................. 152
6.5 UV decontamination .................................................................................. 155
6.6 Camera calibration.................................................................................... 157
6.7 Servicing .................................................................................................. 158
7Troubleshooting .................................................................................................. 159
7.1 Contacting QIAGEN Technical Services....................................................... 159
7.1.1 Creating a support package ............................................................... 159
7.2 Operation................................................................................................. 162
8Glossary ............................................................................................................ 163
9Technical Specifications....................................................................................... 164
9.1 Operating conditions ................................................................................. 164
9.2 Transport conditions................................................................................... 164
9.3 Storage conditions..................................................................................... 164
9.4 Mechanical data and hardware features...................................................... 165
Appendix A .................................................................................................................. 167
Declaration of Conformity .................................................................................... 167
Waste Electrical and Electronic Equipment (WEEE) ................................................. 168
California Proposition 65 Warning ....................................................................... 169
Liability Clause ................................................................................................... 169
Appendix B – EZ2 Connect MDx Accessories ................................................................... 170
Ordering Information........................................................................................... 170
Document Revision History.............................................................................................. 171

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1Introduction
Thank you for choosing the EZ2 Connect MDx. We are confident it will become an integral part of
your laboratory.
This user manual describes the EZ2 Connect MDx.
Before using the EZ2 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 EZ2 Connect MDx (hereafter also referred to as
EZ2) in the following sections:
Introduction — contains the intended use and requirements for users
General information — contains information regarding the intended use and requirements of
the EZ2
Safety Information — includes important information on any hazards related to the EZ2 and
how to properly use the instrument
General Description — an overview of the features of the EZ2
Installation Procedures — instructions on how to set up the instrument before its first use
Operating Procedures — includes instructions related to protocol runs
Maintenance Procedures — contains information about cleaning and maintenance
Troubleshooting — instructions on what to do in case of any problems with the EZ2
Glossary — an alphabetical list of terms or words used in this user manual with explanations
Technical Specification — Technical data
The appendices contain the following information:
Appendix A — Legal requirements for the EZ2
Appendix B – EZ2 Connect MDx Accessories — an overview of the accessories available for
the EZ2 with required ordering information
Ordering Information — Ordering information
Document Revision History — the changes made to the user manual

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1.2 General information
1.2.1 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 EZ2 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.
For technical assistance and more information, please see our Technical Support Center at
support.qiagen.com or call one of the QIAGEN Technical Service Departments or local distributors.
When contacting QIAGEN Technical Services about errors, please have the following information
ready:
EZ2 serial number and software version
Error code (if applicable)
Description of instrument status after error (worktable, consumables, etc.)
Timepoint when the error occurred for the first time
Frequency of error occurrence (i.e., intermittent or persistent error)
EZ2 Support Package (see section 7.1.1)
1.2.2 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.

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1.3 Intended use of the EZ2 Connect MDx
The EZ2 Connect MDx system is designed to perform automated isolation and purification of nucleic
acids in molecular diagnostic and/or molecular biology applications. The EZ2 Connect MDx is
intended to be used only in combination with QIAGEN kits indicated for use with the EZ2 Connect
MDx instrument for the applications described in the kit handbooks. The EZ2 Connect MDx system
is intended for use by professional operators, such as technicians and physicians trained in
molecular biological techniques and the operation of the EZ2 Connect MDx system.
1.4 Requirements for EZ2 users
The table below covers the general level of competence and training necessary for transportation,
installation, use, maintenance, and servicing of the EZ2.
Task Personnel Training and experience
Delivery No special requirements No special requirements
Installation Laboratory technicians or equivalent Appropriately trained and experienced
personnel familiar with the use of
computers and automation in general
Routine use (running protocols) Laboratory technicians or equivalent Professional users, such as technicians
or physicians, trained in molecular
biology techniques
Routine maintenance Laboratory technicians or equivalent Professional users, such as technicians
or physicians, trained in molecular
biology techniques
Servicing and annual maintenance QIAGEN Field Service specialists
only
Specialists trained, certified, and
authorized by QIAGEN
1.5 Materials required
One of the following QIAGEN kits is required to perform automated isolation and purification of
nucleic acids on the EZ2 Connect MDx in the IVD mode of the software:
EZ1 DSP DNA Blood Kit (Catalog Number 62124)
EZ1 DSP Virus Kit (Catalog Number 62724)
The research mode of the software supports the usage of other EZ1&2 or EZ2 kits for life science
applications.
Note: The required sample types and instructions for sample collection, handling and storage are
specified within the kit handbooks.

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Other required materials:
Filter-tips and holders, EZ1 (50) (Catalog number 994900)
Cartridge rack (Catalog number 9027012)
Tip and sample rack (Catalog number 9027009)
USB stick (Catalog number 9026881)
Silicone grease (Catalog number 9027102)
Barcode Reader (Catalog number 9027101)
Note: Only use accessories supplied by QIAGEN.
1.6 Materials required but not provided
Safety glasses
Gloves
Lab coat
1.7 Glossary
For a glossary of terms used in this user manual, refer to the Glossary section (page 163) of this
user manual.
1.8 Accessories
For information about EZ2 accessories, refer to the Appendix B – EZ2 Connect MDx Accessories
section (page 170) of this user manual.

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2Safety Information
Before using the EZ2, 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 user manual.
Always use the EZ2 as specified in this user manual. If the equipment is used in a manner not
specified by the manufacturer, the protection provided by the equipment may be impaired.
The following types of safety information appear in this user manual.
WARNING The term WARNING is used to inform you about situations that could result
in personal injury to you or others.
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 an instrument or other equipment.
Details about these circumstances are given in a box like this one.
The guidance provided in this manual is intended to supplement, not supersede, the normal safety
requirements prevailing in the user’s country.
Please be aware that you may be required to consult your local regulations for reporting serious
incidents that have occurred in relation to the device, to the manufacturer and/or the competent
authority of the Member State (only applicable for CE-marked devices with an authorized
representative established in the EU) and the regulatory authority in which the user and/or the
patient is established.