STAT-Dx DiagCORE User manual

DiagCORE®Analyzer
User manual
Software version 1.0
PL-009-05/2018-EN
110002 OM
110001 AM

2DiagCORE Analyzer User Manual
This document is to be used solely for the purpose of operating the DiagCORE Analyzer. No part of
this document may be reproduced or transmitted by any means, whether electronic or
mechanical, or for any purpose, without the express written permission of STAT-Dx Life, S.L.
Always maintain the DiagCORE Analyzer in good working order. Using the DiagCORE Analyzer in a
manner not specified by STAT-Dx Life, S.L. may impair protection provided by the equipment.
A printed version of this manual is available upon request.
STAT-Dx Life, S.L.
Baldiri Reixac 4
08028 Barcelona, Spain
Customer and technical support
If assistance is required, contact Technical Support using the contact information below.
Website: http.support.qiagen.com
When calling Technical Support about errors, please have the following information ready:
DiagCORE Analyzer serial number, type and version
Error code (if applicable)
Time point when the error occurred for the first time
Frequency of error occurrence (i.e., intermittent or persistent error)
Photo of error, if possible
Copy support package
110001 Analytical Module
110002 Operational Module

DiagCORE Analyzer User Manual 3
Contents
Customer and technical support............................................................................. 2
Contents ...................................................................................................................... 3
Table of symbols ......................................................................................................... 6
1 Information about this user manual ............................................................ 7
1.1 Revision ................................................................................................................ 7
1.2 Intended use of the DiagCORE Analyzer ....................................................... 7
1.3 Limitations of use ................................................................................................ 7
1.4 Sections of the user manual ............................................................................. 8
2 Safety information ......................................................................................... 9
2.1 General safety precautions .............................................................................. 9
2.2 DiagCORE Analyzer transport precautions .................................................. 10
2.3 Electrical safety................................................................................................. 10
2.4 Chemical safety ............................................................................................... 10
2.5 Biological safety ............................................................................................... 11
2.6 Waste disposal .................................................................................................. 12
3 General background.................................................................................. 13
3.1 System description ........................................................................................... 13
3.2 DiagCORE Analyzer description..................................................................... 13
3.3 DiagCORE cartridge description ................................................................... 14
4 Installing the DiagCORE Analyzer.............................................................. 16
4.1 Site requirements .............................................................................................. 16
4.2 What is included with the DiagCORE Analyzer............................................ 17
4.3 Unpacking and installing the DiagCORE Analyzer...................................... 18
4.4 Repackaging and shipping the DiagCORE Analyzer ................................. 22
5 Running a test and viewing results ............................................................ 23
5.1 Starting the DiagCORE Analyzer .................................................................... 23
5.2 Preparing the cartridge................................................................................... 23
5.3 Procedure to run a test.................................................................................... 23
5.3.1 Instructions to abort a test................................................................... 28
5.4 Viewing results................................................................................................... 28
5.4.1 Viewing amplification curves ............................................................. 30

4DiagCORE Analyzer User Manual
5.4.2 Viewing melting curves........................................................................ 31
5.4.3 Viewing test details .............................................................................. 32
5.4.4 Browse results from previous tests....................................................... 33
5.4.5 Exporting results to a USB storage device ......................................... 34
5.4.6 Printing results ........................................................................................ 34
6 System reference ........................................................................................ 35
6.1 Main screen....................................................................................................... 35
6.1.1 General status bar................................................................................ 35
6.1.2 Module status bar................................................................................. 36
6.1.3 Main Menu bar ..................................................................................... 37
6.1.4 Content area ........................................................................................ 38
6.2 Login screen...................................................................................................... 38
6.3 Logging out....................................................................................................... 40
6.4 Screensaver....................................................................................................... 40
6.5 Options menu ................................................................................................... 40
6.6 User management ........................................................................................... 41
6.6.1 Accessing and managing the list of users ........................................ 42
6.6.2 Adding users.......................................................................................... 44
6.7 Assay management ........................................................................................ 45
6.7.1 Managing available assays ................................................................ 45
6.7.2 Importing new assays........................................................................... 46
6.8 Configuring the DiagCORE Analyzer system................................................ 47
6.8.1 Regional settings................................................................................... 47
6.8.2 General settings.................................................................................... 49
6.8.3 Printer settings ....................................................................................... 51
6.8.4 Network settings.................................................................................... 51
6.8.5 HIS/LIS settings ....................................................................................... 53
6.8.6 System log.............................................................................................. 53
6.8.7 Technical log......................................................................................... 54
6.8.8 Version information .............................................................................. 54
6.8.9 System update...................................................................................... 54
6.8.10 System backup ..................................................................................... 55
6.9 Change passwords .......................................................................................... 56
6.10 DiagCORE Analyzer status .............................................................................. 56
6.11 Shutting down the instrument......................................................................... 57

DiagCORE Analyzer User Manual 5
7 Maintenance ............................................................................................... 58
7.1 Maintenance tasks........................................................................................... 58
7.2 Cleaning the DiagCORE Analyzer surface................................................... 58
7.3 Decontaminating the DiagCORE Analyzer surface.................................... 59
7.4 Replacing the air filter...................................................................................... 60
7.5 DiagCORE Analyzer repair.............................................................................. 60
8 Troubleshooting........................................................................................... 61
8.1 Errors and warning messages ......................................................................... 63
9 Appendices ................................................................................................. 67
9.1 Technical specifications.................................................................................. 67
9.2 Disposal information......................................................................................... 67
9.3 Declaration of Conformity .............................................................................. 68
9.4 Glossary.............................................................................................................. 68
9.5 Trademarks and copyright.............................................................................. 68
9.6 Copyright, disclaimer and warranty.............................................................. 68
9.7 Patent statement ............................................................................................. 69
9.8 Software License Agreement ......................................................................... 69
10 Index .......................................................................................................... 71

6DiagCORE Analyzer User Manual
Table of symbols
The table below describes various symbols used throughout this user manual and on the DiagCORE
Analyzer instrument and assay cartridges.
Location
Description
Type plate on the back of the
instrument
CE marking for European Conformity
Type plate on the back of the
instrument
TÜV mark of the TÜV SÜD Product
Service for testing.
Type plate on the back of the
instrument
Legal manufacturer
Type plate on the back of the
instrument
Caution
HAZARD: Risk of personal injury and
material damage
Type plate on the back of the
instrument
WEEE mark for Europe
Type plate on the back of the
instrument
FCC mark of the United States Federal
Communications Commission
Type plate on the back of the
instrument
In vitro diagnostic medical device
Type plate on the back of the
instrument
Catalog number
Type plate on the back of the
instrument
Serial number

DiagCORE Analyzer User Manual 7
1Information about this user manual
Read this user manual carefully and pay particular attention to the safety information before
operating the DiagCORE Analyzer. The instructions and safety information in this user manual must
be followed to ensure safe operation of the instrument and to maintain the instrument in a safe
condition.
1.1 Revision
This is the DiagCORE Analyzer User Manual, version 1.0. This manual is for use with the DiagCORE
Analyzer 1.0 and DiagCORE Application Software version 1.0.
1.2 Intended use of the DiagCORE Analyzer
The DiagCORE Analyzer is intended for in vitro diagnostic use and provides diagnostic results. All
analytical steps are fully automated using molecular diagnostic DiagCORE application cartridges
and real-time PCR detection.
The DiagCORE Analyzer system is intended for professional use only and is not intended for self-
testing.
1.3 Limitations of use
The DiagCORE Analyzer can only be used with DiagCORE cartridges according to the
instructions contained in this user manual and in the DiagCORE cartridge instructions for use.
When connecting the DiagCORE Analyzer, use only the cables supplied with the system.
Any service or repairs should only be performed by personnel authorized by STAT-Dx Life, S.L.
The DiagCORE Analyzer should only be operated if it is on a flat, horizontal surface with no
angles or tilts.
Do not re-run a DiagCORE assay cartridge if it has already been used successfully, or if it has
been associated with an error or an incomplete run.
Allow at least 10 cm clearance on each side of the DiagCORE Analyzer to ensure adequate
ventilation.
Make sure that the DiagCORE Analyzer is positioned away from any air conditioning outlets or
heat exchangers.
Do not move the instrument while a test is running.
Do not change the system configuration during a run.
Do not use the touchscreen to lift or move the DiagCORE Analyzer.

8DiagCORE Analyzer User Manual
1.4 Sections of the user manual
This user manual provides information about the DiagCORE Analyzer in the following sections:
1. Information about this user manual
2. Safety information
3. General background
4. Installing the DiagCORE Analyzer
5. Running a test and viewing results
6. System reference
7. Maintenance
8. Troubleshooting
9. Appendices
The appendices include the following:
Technical specifications
Disposal information
Declaration of Conformity
Glossary
Trademarks and copyright
Copyright, disclaimer and warranty
Patent statement
Software License Agreement

DiagCORE Analyzer User Manual 9
2Safety information
Before using the DiagCORE Analyzer, it is essential to 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.
The following types of safety information appear throughout this manual.
WARNING
The term WARNING is used when referring to situations that could result in
personal injury to the operator or others.
Details about the circumstances are provided in a message like this one.
CAUTION
The term CAUTION is used when referring to situations that could result in
material damage to the DiagCORE Analyzer or other equipment.
Details about the circumstances are provided in a message 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 advice provided in this user manual is intended to supplement, not supersede, the normal
safety requirements prevailing in the user’s country.
2.1 General safety precautions
Use the DiagCORE Analyzer according to this manual. It is highly recommended to carefully read
and become acquainted with the instructions for use before using the DiagCORE Analyzer.
Follow all safety instructions printed on, or attached to, the DiagCORE Analyzer.
Improper use of the DiagCORE Analyzer or failure to comply with its proper installation and
maintenance may cause personal injuries or damage to the DiagCORE Analyzer.
The DiagCORE Analyzer must only be operated by qualified and appropriately trained
healthcare personnel.
Servicing of the DiagCORE Analyzer must only be performed by Field Service Specialists
authorized by STAT-Dx Life, S.L.
Do not use the DiagCORE Analyzer in hazardous environments for which it has not been
designed.

10 DiagCORE Analyzer User Manual
WARNING
CAUTION
Risk of personal injury and material damage
Do not open the housing of the DiagCORE Analyzer. The housing of the
DiagCORE Analyzer is designed to protect the operator and to ensure
proper operation of the DiagCORE Analyzer. Using the DiagCORE Analyzer
without the housing leads to electrical hazards and DiagCORE Analyzer
malfunction.
WARNING
CAUTION
Risk of personal injury and material damage
Use caution when the lid of the cartridge entrance port closes to avoid
personal injury, such as pinched fingers.
2.2 DiagCORE Analyzer transport precautions
WARNING
CAUTION
Risk of personal injury and material damage
The DiagCORE Analyzer is a heavy instrument. To avoid personal injury or
damage to the DiagCORE Analyzer, take care when lifting it and use
appropriate lifting methods.
2.3 Electrical safety
Observe all general safety precautions that apply to electrical instruments.
Disconnect the line power cord from the power outlet before servicing.
WARNING
Electrical hazard
Lethal voltages inside the DiagCORE Analyzer. Do not open the housing
of the DiagCORE Analyzer.
The line power cord must be connected to a line power outlet that has
a protective conductor (earth/ground).
Do not touch any switches or power cords with wet hands.
Do not use the instrument outside of the specified power conditions.
2.4 Chemical safety
Material safety data sheets for the cartridge materials are available and can be requested from
STAT-Dx Life, S.L.
Used cartridges must be disposed of in accordance with all national, state and local health and
safety regulations and laws.

DiagCORE Analyzer User Manual 11
WARNING
Hazardous chemicals
Chemicals may leak from the cartridge in the event that the cartridge
housing is damaged. Some chemicals used in DiagCORE cartridges may
be hazardous or may become hazardous. Always wear eye protection,
gloves and a lab coat.
CAUTION
Risk of damage to the DiagCORE Analyzer
Avoid spilling chemicals or other liquids into or out of the DiagCORE
Analyzer. Damage caused by liquid spillage will void the warranty.
2.5 Biological safety
The DiagCORE Analyzer and cartridges do not themselves contain biohazardous materials,
however, samples and reagents containing materials from biological sources should generally be
handled and disposed of as potentially biohazardous. Use safe laboratory procedures as outlined
in publications such as Biosafety in Microbiological and Biomedical Laboratories, from the Centers
for Disease Control and Prevention and the National Institutes of Health
(www.cdc.gov/od/ohs/biosfty/biosfty.htm).
Samples tested on the DiagCORE Analyzer 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 and disposable
powder-free gloves when handling reagents or samples, and wash hands thoroughly thereafter.
Always observe safety precautions as outlined in relevant guidelines, such as the Clinical and
Laboratory Standards Institute (CLSI) Protection of Laboratory Workers from Occupationally
Acquired Infections, Approved Guidelines M29, or other appropriate documents provided by:
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)
Avoid contamination of the DiagCORE Analyzer and workspace by handling samples and
DiagCORE cartridges with care. In the event of contamination (e.g., a leak from a cartridge), clean
and decontaminate the affected area and the DiagCORE Analyzer.
WARNING
Biological hazard
Use caution when loading or removing cartridges containing infectious
samples into or from the DiagCORE Analyzer. A break in the cartridge
could contaminate the DiagCORE Analyzer and the surrounding area.
All cartridges should be handled as if they contain potentially infectious
agents.

12 DiagCORE Analyzer User Manual
CAUTION
Risk of contamination
Contain and clean contamination from a broken or visibly damaged
cartridge immediately. Contents, though not infectious, can be spread
by normal activity and may contaminate further analytical results,
leading to false positives.
For instructions on cleaning and decontaminating the DiagCORE Analyzer, refer to sections 7.2
Cleaning the DiagCORE Analyzer surface and 7.3 Decontaminating the DiagCORE Analyzer
surface.
2.6 Waste disposal
Used cartridges and plasticware may contain hazardous chemicals or infectious agents. Such
waste must be collected and disposed of properly in accordance with all national, state and local
health and safety regulations and laws.

DiagCORE Analyzer User Manual 13
3General background
3.1 System description
The DiagCORE Analyzer, in combination with DiagCORE assay cartridges, uses real-time PCR to
detect pathogen nucleic acids in human biological samples. The DiagCORE Analyzer and
cartridges are designed as a closed system that enables hands-off sample preparation followed
by detection and identification of pathogen nucleic acids. Samples are inserted into a DiagCORE
cartridge, which carries on board all reagents necessary to isolate and amplify nucleic acids from
the sample. Detected real-time amplification signals are interpreted by the integrated software
and are reported via an intuitive user interface.
3.2 DiagCORE Analyzer description
The DiagCORE Analyzer consists of an Operational Module and an Analytical Module. The
Operational Module includes elements that provide connectivity to the Analytical Module and
enable user interaction with the DiagCORE Analyzer. The Analytical Module contains the hardware
and software for sample testing and analysis.
The DiagCORE Analyzer includes the following elements:
Touchscreen for user interaction with the DiagCORE Analyzer
Barcode reader for sample, patient and cartridge identification
USB ports for assay and system upgrades, document export and printer connectivity (one in
front, three in back)
Cartridge entrance port for inserting DiagCORE cartridges into the DiagCORE Analyzer
Ethernet connector for network connectivity

14 DiagCORE Analyzer User Manual
The following images show the locations of various DiagCORE Analyzer features.
Front view of the DiagCORE Analyzer. The Operational Module is on the left, and the Analytical
Module is on the right.
Rear view of the DiagCORE Analyzer. The Operational Module is on the right, and the
Analytical Module is on the left.
3.3 DiagCORE cartridge description
The DiagCORE qPCR cartridge is a disposable plastic device that allows performance of fully
automated molecular assays. Main features of the DiagCORE qPCR cartridge include compatibility
with various sample types (e.g., fluids, swabs), hermetical containment of all pre-loaded reagents
necessary for testing, and true walk-away operation. All sample preparation and assay testing
steps are performed within the cartridge.
All reagents required for the complete execution of a test run are pre-loaded and self-contained
in the DiagCORE cartridge. The user does not need to come in contact with and/or manipulate
any reagents. During the test, reagents are handled in the Analytical Module by pneumatically
operated microfluidics and make no direct contact with the DiagCORE Analyzer actuators. The

DiagCORE Analyzer User Manual 15
DiagCORE Analyzer houses air filters for both incoming and outgoing air, further safeguarding the
environment. After testing, the cartridge stays hermetically closed at all times, greatly enhancing
its safe disposal.
Within the cartridge, multiple steps are automatically performed in sequence using pneumatic
pressure to transfer samples and fluids via the transfer chamber to their intended destinations. After
the cartridge is introduced into the DiagCORE Analyzer, the following assay steps occur
automatically:
Resuspension of internal control
Cell lysis using mechanical and/or chemical means
Membrane-based nucleic acid purification
Mixing of the purified nucleic acid with lyophilized master mix reagents
Transfer of defined aliquots of eluate/master mix to different reaction chambers
Performance of real-time, multiplex PCR testing within each reaction chamber. An increase in
fluorescence, indicating presence of the target analyte, is detected directly within each
reaction chamber.
The general layout of the cartridge and its features are illustrated below.
DiagCORE cartridge.

16 DiagCORE Analyzer User Manual
4Installing the DiagCORE Analyzer
4.1 Site requirements
Select a flat, dry and clean workbench space for the DiagCORE Analyzer. Ensure that the space is
free of excessive drafts, moisture and dust, as well as protected from direct sunlight, large
temperature fluctuations, heat sources, vibration and electrical interference. Refer to section 9.1
Technical specifications of the appendix for the weight and dimensions of the DiagCORE Analyzer
and the correct operating conditions (temperature and humidity). The DiagCORE Analyzer should
have sufficient clearance on all sides to enable proper ventilation, and to allow unimpeded access
to the cartridge entrance port, the back of the DiagCORE Analyzer, the ON/OFF button, the
barcode reader and the touchscreen.
CAUTION
Impeded ventilation
To ensure proper ventilation, maintain a minimum clearance of 10 cm at
the rear of the DiagCORE Analyzer and do not block airflow under the
unit.
Slits and openings that ensure instrument ventilation must not be
covered.
CAUTION
Electromagnetic interference
Do not place or use the DiagCORE Analyzer in close proximity of sources
of strong electromagnetic radiation (e.g., unshielded intentional RF
sources), as these can interfere with proper operation.
NOTE
Before installing and using the DiagCORE Analyzer, refer to section 9.1
Technical specifications of the appendix to become familiar with the
DiagCORE Analyzer operating conditions.

DiagCORE Analyzer User Manual 17
4.2 What is included with the DiagCORE Analyzer
The DiagCORE Analyzer is delivered in two separate boxes and includes all the necessary
components for setting up and operating the system. The contents of the boxes are described
below.
Box 1 contents:
1x Analytical Module
1x USB storage device containing the user manual and quick-
start guide in multiple languages
1x Power cord
1x Analytical/Analytical Module bridge
1x Termination bridge
1x Analytical-Operational Module assembly tool
1x Screen suede

18 DiagCORE Analyzer User Manual
1x Protective cover removal tool
Box 2 contents:
1x Operational Module
1x Analytical/Operational Module bridge
4.3 Unpacking and installing the DiagCORE Analyzer
Carefully unpack the DiagCORE Analyzer according to the following steps:
1. Remove the Analytical Module from its box and place it on a level surface. Remove the foam
pieces attached to the Analytical Module.
WARNING
CAUTION
Risk of personal injury and material damage
The DiagCORE Analyzer is a heavy instrument. To avoid personal injury
or damage to the DiagCORE Analyzer, take care when lifting and use
appropriate lifting methods.
The analyzer must be lifted and handled by taking it from the base with two hands, as shown in the
figure below.

DiagCORE Analyzer User Manual 19
2. Remove the protective covers from the side of the Analytical Module using the protective cover
removal tool delivered with the DiagCORE Analyzer.
3. Remove the Operational Module from its box and attach it to the left side of the Analytical
Module. Tighten the screws using the Analytical-Operational Module assembly tool delivered
with the DiagCORE Analyzer.
CAUTION
Risk of mechanical damage
Do not leave the Operational Module without support or resting on the
screen, as this may damage the touchscreen.

20 DiagCORE Analyzer User Manual
4. Reattach the protective covers on the side of the Analytical Module.
5. Connect the Analytical/Operational Module bridge at the back of the DiagCORE Analyzer to
link the Operational and Analytical Modules together.
6. Connect the termination bridge at the back of the Analytical Module.