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.

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2.1 Proper use
WARNING/
CAUTION
Risk of personal injury and material damage
Improper use of the EZ2 may cause personal injuries or damage to the
instrument. The EZ2 must only be operated by qualified personnel who have
been appropriately trained. Servicing of the EZ2 instrument must only be
performed by a QIAGEN Field Service Specialist.
WARNING/
CAUTION
Risk of personal injury
The EZ2 is too heavy to be lifted by one person. To avoid personal injury or
damage to the instrument, do not lift the instrument alone Use the handle
attached to the box to lift the EZ2. After the EZ2 has been unpacked, two
people must lift the instrument. Lift the instrument by placing your hands
underneath the bottom of the instrument.
WARNING Risk of personal injury and material damage
Do not attempt to move the EZ2 during operation.
Perform the maintenance as described in the Maintenance Procedures section (see page 141).
QIAGEN charges for repairs that are required due to incorrect maintenance.
In case of emergency, power OFF the EZ2 at the power switch located in front of the instrument
and unplug the power cord from the power outlet.
CAUTION
Damage to the instrument
Avoid spilling water or chemicals onto the EZ2. Instrument damage caused
by water or chemical spillage will void your warranty.

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WARNING Risk of fire or explosion
When using ethanol or ethanol-based liquids on the EZ2, handle such liquids
carefully and in accordance with the required safety regulations. If liquid has
been spilled, wipe it off and leave the EZ2 hood open to allow flammable
vapors to disperse.
WARNING Risk of fire or explosion
The EZ2 is intended for use with reagents and substances supplied with
QIAGEN kits as outlined in respective Information for use. Use of other
reagents and substances may lead to fire or explosion.
If hazardous material is spilled on or inside the EZ2, the user is responsible for carrying out
appropriate decontamination.
Note: Do not place items on top of the EZ2.
CAUTION
Damage to the instrument
Ensure that the EZ2 is switched off (power OFF) and mains plug removed
from power outlet before you manually move the mechanical components of
the instrument.
CAUTION
Damage to the instrument
Do not lean against the instrument or touchscreen.

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2.2 Electrical safety
Note: If operation of the instrument is interrupted in any way (for example, due to interruption of
the power supply or a mechanical error), first switch off the EZ2 instrument, then disconnect the
electrical cord from the power supply before attempting troubleshooting.
WARNING Electrical hazard
Any interruption of the protective conductor (earth/ground lead) inside or
outside the instrument or disconnection of the protective conductor terminal is
likely to make the instrument dangerous.
Intentional interruption is prohibited.
Lethal voltages inside the instrument
When the instrument is connected to line power, terminals may be live and
opening covers or removing parts is likely to expose live parts.
WARNING Damage to electronics
Before powering ON the instrument, make sure that the correct supply voltage
is used.
Use of incorrect supply voltage may damage the electronics.
To check the recommended supply voltage, refer to the specifications
indicated on the type plate of the instrument.

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WARNING Risk of electric shock
Do not open any panels on the EZ2.
Risk of personal injury and material damage
Only perform maintenance that is specifically described in this user manual.
Any other maintenance or repair may only be carried out by authorized field
service.
To ensure satisfactory and safe operation of the EZ2, follow the advice below:
The line power cord must be connected to a line power outlet that has a protective conductor
(earth/ground).
Place instrument in a location so that the power cord is accessible and can be readily
connected/disconnected.
Use only the power cord delivered by QIAGEN.
Do not adjust or replace internal parts of the instrument.
Do not operate the instrument with any covers or parts removed.
If liquid has spilled inside the instrument, switch off the instrument, and if the spill has not been
completely contained in the tray, disconnect it from the power outlet, and contact QIAGEN
Technical Services for advice before attempting any troubleshooting.
If the instrument becomes electrically unsafe, prevent other personnel from operating it and contact
QIAGEN Technical Services.
The instrument may be electrically unsafe when:
The EZ2 or the line power cord appear to be damaged.
The EZ2 has been stored in unfavorable conditions for a prolonged period.
The EZ2 has been subjected to severe transport stresses.
Liquids have come into direct contact with electrical components of the EZ2.
The power cord has been exchanged with a non-official power cord.
WARNING Electric hazard
Do not touch the EZ2 with wet hands.

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WARNING Electric hazard
Never install a fuse different from that specified in the user manual.
2.3 Operating conditions
Parameters such as temperature range and humidity range are described in the Technical
Specification section (see page 164).
WARNING Explosive atmosphere
The EZ2 instrument is not designed for use in an explosive atmosphere.
WARNING Risk of overheating
To ensure proper ventilation, maintain a minimum clearance of 10 cm at the
sides and rear of the EZ2.
Slits and openings that ensure the ventilation of the instrument must not be
covered.
WARNING Risk of explosion
The EZ2 is intended for use with reagents and substances supplied with
QIAGEN kits. Use of other reagents and substances may lead to fire or
explosion.

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CAUTION Damage to the instrument
Direct sunlight may bleach parts of the instrument, cause damage to plastic
parts or interfere with the correct function of the load check. The EZ2 must be
located out of direct sunlight.
CAUTION Damage to the instrument
Do not use the EZ2 in the vicinity of sources of strong electromagnetic
radiation (for example unshielded, deliberately operated high-frequency
sources or mobile radio devices), because these can interfere with the proper
operation.
2.4 Biological safety
Samples and reagents containing materials from humans should be treated as potentially
infectious. Use safe laboratory procedures as outlined in publications such as Biosafety in
Microbiological and Biomedical Laboratories, HHS (https://www.cdc.gov/labs/pdf/CDC-
BiosafetymicrobiologicalBiomedicalLaboratories-2009-P.pdf). You should be aware of the health
hazard presented by such agents and should use, store, and dispose of such samples according
to the required safety regulations.

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WARNING Samples containing infectious agents
Samples used with the EZ2 instrument may contain infectious agents. Handle
such samples with the greatest of care and in accordance with the required
safety regulations.
Always wear safety glasses, gloves, and a lab coat.
The responsible body (for example, a laboratory manager) must take the
necessary precautions to ensure that the surrounding workplace is safe, and
that the instrument operators are suitably trained and not exposed to
hazardous levels of infectious agents as defined in the applicable Material
Safety Data Sheets (MSDSs) or the OSHA1,* ACGIH,†or COSHH‡
documents.
Venting for fumes and disposal of wastes must be in accordance with all
national, state, and local health and safety regulations and laws.
* OSHA — Occupational Safety and Health Administration (United States of America)
†ACGIH – American Conference of Government Industrial Hygienists (United States of America)
‡COSHH – Control of Substances Hazardous to Health (United Kingdom)

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2.5 Chemicals
WARNING Hazardous chemicals
Some chemicals used with the EZ2 instrument may be hazardous or may
become hazardous after completion of a purification run.
Always wear safety glasses, gloves, and a lab coat.
The responsible body (for example, a laboratory manager) must take the
necessary precautions to ensure that the surrounding workplace is safe, and
that the instrument operators are not exposed to hazardous levels of toxic
substances (chemical or biological) as defined in the applicable Material
Safety Data Sheets (MSDSs) or the OSHA,* ACGIH,†or COSHH‡documents.
Venting for fumes and disposal of wastes must be in accordance with all
national, state, and local health and safety regulations and laws.
* OSHA: Occupational Safety and Health Administration (United States of America).
†ACGIH: American Conference of Government Industrial Hygienists (United States of America).
‡COSHH: Control of Substances Hazardous to Health (United Kingdom).
Toxic Fumes
WARNING Toxic fumes
Do not use bleach to clean or disinfect the EZ2 instrument. Bleach in contact
with salts from the buffers can produce toxic fumes.
WARNING Toxic fumes
Do not use bleach to disinfect used labware. Bleach in contact with salts from
the buffers can produce toxic fumes.
Note: If you work with volatile solvents, toxic substances, etc., you must provide an efficient
laboratory ventilation system to remove vapors that may be produced.

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2.6 Waste disposal
Used consumables, such as reagent cartridges and disposable filter-tips, may contain hazardous
chemicals or infectious agents from the purification process. Such waste must be collected and
disposed of properly, according to local safety regulations.
For information about how to dispose of the EZ2 instrument, see Appendix A: Waste Electrical and
Electronic Equipment (WEEE).
CAUTION
Hazardous chemicals and infectious agents
Waste may contain toxic or infectious material and must be disposed of
properly. Refer to
your local safety regulations for proper disposal
procedures.
2.7 Mechanical hazards
The hood of the EZ2 must remain closed during operation of the instrument. Only open the hood
when instructed to do so by the instruction for use or when prompted by the GUI.
The worktable of the EZ2 instrument moves during operation of the instrument. While loading the
worktable, always stand clear of the instrument. Do not lean on the worktable when the pipetting
unit of the instrument is moving to reach loading position with its lid open. Wait until the pipetting
unit completes its movements before you start to load or unload.
WARNING
Moving parts
To avoid contact with moving parts during the operation of the EZ2, the
instrument must be operated with the hood closed.
The hood is locked during operation for safety reasons and a sensor detects
the hood position. If the hood sensor or lock is not functioning correctly,
contact QIAGEN Technical Services.

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WARNING Moving parts
Avoid contact with moving parts during operation of the EZ2. Under no
circumstances should hands be placed under the pipetting unit during
movement. Do not attempt to remove any plasticware from the worktable
whilst the instrument is operating.
2.8 Heat hazard
The EZ2 worktable contains a heating system.
WARNING Hot surface
The heating system can reach temperatures of up to 95°C (203°F). Avoid
touching it when it is hot, in particular shortly after a run has been carried
out.
2.9 Radiation
The EZ2 instrument has a UV LED lamp. The wavelength of the UV light produced by the UV LED
lamp is 275 to 285 nm. This wavelength corresponds to ultraviolet light Type C, which can be used
to support decontamination procedures. A mechanical lock ensures that the hood is closed for
operation of the UV LED. If the hood sensor or lock is not functioning correctly, contact QIAGEN
Technical Services.
WARNING UV radiation
Avoid looking directly into UV light. Do not expose your skin to UV light.
The EZ2 instrument has a 2D handheld barcode scanner to allow kit bar code and sample barcode
scanning.
WARNING Risk of personal injury
Hazard Level 2 laser light: Do not stare into the light beam when using
handheld barcode scanner.