Qiagen QIAreach eHub User manual

Sample to Insight__
October 2020
QIAreachTM eHub
User Manual
9002969
QIAGEN GmbH, QIAGEN Strasse 1, D
-40724 Hilden
R
2
1118891EN

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Contents
1Introduction .............................................................................................................5
1.1 About this user manual....................................................................................5
1.2 General Information........................................................................................6
1.3 Intended use of the QIAreach eHub..................................................................6
1.4 Symbols on the QIAreach eHub .......................................................................8
2Safety Information ..................................................................................................10
2.1 Proper use ...................................................................................................11
2.2 Electrical safety ............................................................................................11
2.3 Chemical safety............................................................................................11
2.4 Biological safety...........................................................................................12
2.5 Waste disposal ............................................................................................12
3General Description ...............................................................................................13
3.1 System description........................................................................................13
3.2 QIAreach eHub description ...........................................................................13
4Installation Procedures ............................................................................................15
4.1 Site requirements..........................................................................................15
4.2 QIAreach eHub delivery and components .......................................................16
4.3 Unpacking and installing the QIAreach eHub ..................................................18
5Operating the QIAreach eHub ................................................................................19
5.1 Setting up the QIAreach eHub for use.............................................................19
5.2 Running a test on the QIAreach eHub .............................................................21
5.3 Shutting down the QIAreach eHub .................................................................22
5.4 Software updates .........................................................................................22
6QIAreach eHub Functions .......................................................................................23
6.1 Display screen icons .....................................................................................23
6.2 Battery LED indicator.....................................................................................24
7Maintenance .........................................................................................................25
7.1 Cleaning the QIAreach eHub after use............................................................25
8Troubleshooting .....................................................................................................26

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8.1 General information......................................................................................26
8.2 Contacting QIAGEN Technical Services ..........................................................26
8.3 QIAreach eHub error codes...........................................................................26
9Technical Specifications ..........................................................................................32
10 Appendix A – Technical Data..................................................................................34
10.1 FCC Compliance: Supplier’s Declaration of Conformity ................................34
10.2 Waste Electrical and Electronic Equipment (WEEE).......................................36
10.3 Disclaimer of warranties............................................................................36
11 Ordering Information..............................................................................................37
12 Document Revision History ......................................................................................38

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1Introduction
This manual describes how to operate the QIAreach eHub. Before using the QIAreach eHub, it is
essential that you read this user manual carefully and pay particular 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 QIAreach eHub in the following sections:
Introduction
Safety Information
General Description
Installation Procedures
Operation
System Functions
Maintenance
Troubleshooting
Technical Specifications
The Appendix section contains the following information:
Declaration of Conformity
Waste Electrical and Electronic Equipment (WEEE)
Disclaimer of warranties

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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 QIAreach eHub or QIAGEN products in
general, do not hesitate to contact us.
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).
When contacting QIAGEN Technical Services about errors, please have the following information
ready:
QIAreach eHub serial number
Test type and test kit lot number
Error code (if applicable)
Timestamp when the error occurred for the first time
Frequency of error occurrence (i.e., intermittent or persistent error)
Photo of error, if possible
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.
In an effort to produce useful and appropriate documentation, we appreciate your comments on
this user manual. Please contact QIAGEN Technical Services.
1.3 Intended use of the QIAreach eHub
The QIAreach eHub is intended for use in conjunction with QIAreach in vitro diagnostic tests.
QIAreach technology on the digital detection eStick provides diagnostic results that are displayed
to the user on the QIAreach eHub visual display.

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The QIAreach eHub and QIAreach test systems are intended for professional use only and not
intended for self-testing.
1.3.1 Limitations of use
The QIAreach eHub can only be used with QIAreach eSticks according to the instructions
contained in this user manual and in the applicable QIAreach test Instructions for Use.
When powering the QIAreach eHub or connecting to a computer, use only the USB cable
supplied with this product.
When charging the QIAreach eHub, use only the USB charger and USB cable supplied with
this product.
The QIAreach eHub should only be operated on a flat, horizontal surface with no angles or
tilts.
Do not re-run a QIAreach assay eStick if it has already been used successfully or if it has been
associated with an error or an incomplete run.
Ensure that the QIAreach eHub is positioned away from any air conditioning outlets, heaters,
or sources of intense light.
Do not move the QIAreach eHub while a test is running.
Do not remove a QIAreach test eStick from the eHub before the run has completed.

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1.4 Symbols on the QIAreach eHub
The following symbols may appear on the packaging or labelling.
Symbol Location Description
Type plate and outer box label of the eHub CE mark
Type plate on the bottom of the eHub FCC Mark
Type plate and outer box label of the eHub WEEE Mark for Europe
Type plate and outer box label of the eHub Legal Manufacturer
Type plate and outer box label of the eHub Catalog Number
Type plate and outer box label of the eHub Serial Number
Type plate and outer box label of the eHub Global Trade Item Number
Outer box label of the eHub Fragile
Type plate and outer box label of the eHub Electrical Safety Regulatory
Compliance Mark (Australia
and New Zealand)
Type plate and outer box label of the eHub Consult Instructions for Use
Type plate and outer box label of the eHub Attention
Type plate and outer box label of the eHub RoHS mark for China (the
restriction of the use of
certain hazardous
substances in electrical and
electronic equipment)

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Type plate and outer box label of the eHub UL mark that indicates the
instrument complies with the
applicable standards for
electrical safety
Front of the eHub Biohazard

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2Safety Information
Before using the QIAreach eHub, it is essential that you read this user manual carefully and pay
particular attention to the safety information. The instructions and safety information in the user
manual must be followed to ensure safe operation of the eHub and to maintain a safe working
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.
If the QIAreach eHub 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 throughout the QIAreach eHub 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 the QIAreach eHub
or to other equipment.
Details about these circumstances are given in a box like this one.
Important The term Important is used to highlight information that is critical for the
completion of a task or optimal performance of the system.
Note The term Note is used for information that explains or clarifies a specific case
or task.
The guidance provided in this manual is intended to supplement, not supersede, the normal safety
requirements prevailing in the user’s country.

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2.1 Proper use
Use the QIAreach eHub according to this user manual. We highly recommend to carefully
read and become acquainted with the Instructions for Use before running a QIAreach test.
Improper use of the QIAreach eHub may cause personal injuries or damage to the eHub.
The QIAreach eHub must only be operated by qualified and appropriately trained QIAGEN
personnel.
Do not use the QIAreach eHub in hazardous environments for which it has not been
designed.
2.2 Electrical safety
Observe all general safety precautions that apply to electrical instruments. This device has been
tested for compliance with electrical safety requirements as per IEC 61010-1: Safety requirements
for electrical equipment for measurement, control, and laboratory use - Part 1: General
requirements.
WARNING/
CAUTION
Do not open the QIAreach eHub. No user-serviceable parts inside.
Opening of the eHub device could lead to user injury or damage of
the device.
(W1)
2.3 Chemical safety
Safety Data Sheets (SDSs) for QIAreach test kit materials are available and can be requested from
QIAGEN. Used QIAreach assay eSticks should be disposed of in accordance with all national,
state, and local health and safety regulations and laws.

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2.4 Biological safety
WARNING
Spilling or leakage
of test samples has the potential to introduce
biohazardous material onto the exterior surfaces of the QIAreach
eHub. Refer to the Maintenance section of this user man
ual for
instructions on cleaning the QIAreach eHub. Use suitable disinfectants.
The QIAreach eHub itself does not contain any biohazardous material.
(W2)
Samples tested on the QIAreach eHub may contain infectious agents. Users 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. Wear personal protective equipment when handling
reagents or samples, and wash hands thoroughly thereafter.
Always observe safety precautions as outlined in relevant guidelines. Avoid contamination of the
QIAreach eHub and workspace by handling samples and QIAreach test eSticks with care. In the
event of contamination, clean and decontaminate the affected area of the QIAreach eHub.
For instructions on cleaning and decontaminating the QIAreach eHub, see Maintenance.
2.5 Waste disposal
For disposal of waste electrical and electronic equipment (WEEE), see Waste Electrical and
Electronic Equipment (WEEE).

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3General Description
3.1 System description
The QIAreach eHub, in combination with QIAreach assay eSticks, provides a simplified workflow
for multiple in vitro diagnostic tests, using state-of-the-art nanoparticle fluorescence detection
technology. QIAreach assay eSticks are single-use tests that include a lateral flow strip and
optoelectronics that perform test measurements and interpret results. The QIAreach eHub provides
power to the QIAreach test eStick to run the test when the test eStick is connected to any one of the
eHub eStick ports. The QIAreach eHub visually communicates test progress and results to the user
via a display screen specific to each eHub port.
Optional PC software is provided with the QIAreach eHub. The QIAreach eHub will transmit test
information and results when connected to a computer running QIAreach software.
3.2 QIAreach eHub description
The QIAreach eHub is a connection hub that provides power to perform multiple QIAreach tests
simultaneously. The eHub is connected to a power source using the provided connection cable and
features a rechargeable lithium battery to allow QIAreach tests to be performed when a continuous
power supply is not available. QIAreach test results are interpreted on the QIAreach test eStick
firmware, and results are transmitted to the eHub which then communicates to the user by means of
a visual display.
The QIAreach eHub USB charger and USB cable allow the eHub to be powered from either an
electrical outlet or from a computer equipped with USB ports. Use of the optional QIAreach
software requires the QIAreach eHub to be connected to a computer. For instructions on how to
use the software, refer to QIAreach Software User Guide.
The QIAreach eHub includes the following elements:
QIAreach eStick connection ports for up to eight (8) separate tests
Visual display screen centered above each individual eStick connection port
QIAreach test processing tube holder slot positioned directly behind each visual display
screen
QIAreach test sample tube holder slot positioned directly behind each processing tube holder
slot, to be used for applicable QIAreach tests
USB-C port for connection to a USB charger (supplied) or computer

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Battery LED indicator
Figures 1 and 2 show the location of various QIAreach eHub features.
Figure 1. Front view of QIAreach eHub.
Figure 2. Side view of QIAreach eHub.

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4Installation Procedures
4.1 Site requirements
Select a flat, dry, and clean workbench space for the QIAreach eHub. Make sure that the space is
free of excessive moisture and dust, protected from direct sunlight, large temperature fluctuations,
heat sources, vibration and electrical interference. Refer to Section 9 for the weight and dimensions
of the QIAreach eHub and the correct operating conditions (temperature and humidity). There
should be sufficient clearance on the workbench to allow unimpeded access to the eStick connection
ports, USB port, and ON/OFF button.
Note: Before installing and using the QIAreach eHub, see Operating the QIAreach eHub to become
familiar with the QIAreach eHub operating conditions.
CAUTION
Do not place the QIAreach eHub in close proximity to sources of strong
electromagnetic radiation (e.g., unshielded intentional RF sources), as
these can interfere with proper operation. For more information, see
FCC Compliance: Supplier’s Declaration of Conformity.
(C2)

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4.2 QIAreach eHub delivery and components
The QIAreach eHub is delivered in a single box and includes all the necessary components for
setting up and connecting the eHub. The contents of the box are described below:
Note: QIAreach tests kits (sold separately) are required to perform QIAreach testing.
Components Description
1x QIAreach eHub
1x Dust cover
1x USB drive containing QIAreach PC
software
1x USB-C – USB-A Cable, 1.5m length
1x USB Charger Power adapter with region
specific plugs

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The following components are required for testing but are provided in separate test kits. These
components can be purchased separately.
Components Description
QIAreach eStick – product specific
Processing Tube – product specific
Buffer – product specific

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4.3 Unpacking and installing the QIAreach eHub
The QIAreach eHub is delivered ready for use and does not require any hands-on assembly
procedures.
Remove the QIAreach eHub from its delivery box and place on a flat, level surface.
The QIAreach eHub should be charged prior to use. To charge the eHub, connect the USB cable
from the QIAreach eHub USB port to either the supplied power adapter or to a computer. While
charging, the Battery LED indicator flashes a green light. When fully charged, then light changes
to a solid green if the unit is on.
Figure 3. Connecting the USB cable to the QIAreach eHub USB port.
Note:The QIAreach eHub will charge more quickly when charged through the supplied USB
charging adapter, compared to when it is charged through a computer USB port.
The QIAreach eHub comes with a dust cover to protect the internal ports from dust buildup and
contamination. The cover should always be placed over the front panel of the eHub when not in
use. When ready to operate the eHub, the dust cover can be removed from the front panel and
set aside.

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5Operating the QIAreach eHub
5.1 Setting up the QIAreach eHub for use
1. Remove the dust cover from the front panel of the QIAreach eHub and set aside.
Figure 4. Removing the dust cover from the front of QIAreach eHub prior to use.
2. Ensure that the provided USB cable is connected to the QIAreach eHub and an adequate
power source (power outlet or computer).
Note: We recommend to fully charge the QIAreach eHub in a switched off state overnight
(when not in use). We also recommend that you connect the eHub to a USB power source
(either a USB adapter or computer) during operation. If testing is performed without the use of
associated QIAreach software, then we recommend to connect the QIAreach eHub to a
power outlet (if available) through the provided USB power adapter and USB cable.
3. To turn on the QIAreach eHub, press ON/OFF on the side of the unit until the visual display
screen lights up.
Figure 5. Press the ON/OFF switch to turn on the QIAreach eHub.
4. Check battery LED indicator to ensure that the eHub has sufficient charge for the test
operation. For different battery LED indicator states, see Battery LED indicator.

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Once the QIAreach eHub is ready for use, the visual display screen above each available QIAreach
eStick connection port will display the “Insert eStick” icon shown below.
Figure 6. Insert eStick icon. This signifies that a QIAreach eHub port is available for use.