Qiagen QIAcuity 911000 User manual

Sample to Insight__
June 2022
QIAcuity®
User Manual
911000, 911020, 911040, 911050
QIAGEN GmbH
QIAGEN Strasse 1, 40724 Hilden
, GERMANY

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Contents
Introduction .......................................................................................................................7
About this user manual .............................................................................................7
Intended use of the QIAcuity......................................................................................8
Requirements for QIAcuity users...............................................................................10
Safety Information ............................................................................................................11
Proper use.............................................................................................................11
Electrical safety......................................................................................................13
Environment...........................................................................................................14
Biological safety ....................................................................................................14
Chemicals .............................................................................................................15
Maintenance safety ................................................................................................16
Radiation safety .....................................................................................................16
Symbols on the QIAcuity.........................................................................................17
General Description..........................................................................................................18
QIAcuity principle ..................................................................................................18
External features of QIAcuity ...................................................................................20
Thermal cycler .......................................................................................................23
Optical system.......................................................................................................24
Installation Procedure........................................................................................................25
Installation of AC power cord ..................................................................................27
Unpacking the QIAcuity..........................................................................................28
Packing the QIAcuity ..............................................................................................28
Installing the QIAcuity.............................................................................................29
Upgrading QIAcuity Software Suite to new version ....................................................38
Uninstalling the QIAcuity Software Suite ...................................................................46
Updating the instrument software .............................................................................49
Establishing a connection between the QIAcuity instrument and the QIAcuity Software
Suite.....................................................................................................................51
Getting started with the QIAcuity .............................................................................65

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Operating the QIAcuity Instrument......................................................................................71
Operating the QIAcuity Software Suite ...............................................................................93
Getting started.......................................................................................................93
Concepts of the QIAcuity Software Suite...................................................................95
Audit trail............................................................................................................134
Setting up an experiment ......................................................................................145
Defining General Data..........................................................................................148
Setting up templates .............................................................................................168
Analysis..............................................................................................................172
Reports ...............................................................................................................244
Sign report ..........................................................................................................248
Archive ...............................................................................................................251
Re-analysis of plates after QIAcuity Software Suite version upgrade ...........................254
Volume Precision Factor (VPF)................................................................................255
Operating Plates ............................................................................................................258
QIAcuity Nanoplate 26K 24-well...........................................................................259
QIAcuity Nanoplate 26K 8-well.............................................................................259
QIAcuity Nanoplate 8.5K 24-well..........................................................................259
QIAcuity Nanoplate 8.5K 96-well..........................................................................260
Maintenance Procedures .................................................................................................263
Cleaning agents...................................................................................................263
Servicing.............................................................................................................266
Regular maintenance procedure of QIAcuity ...........................................................267
Periodic maintenance ...........................................................................................267
Decontaminating the QIAcuity ...............................................................................269
Regular maintenance procedure for QIAcuity Instrument Software..............................269
Regular maintenance procedure for QIAcuity Software Suite .....................................271
Troubleshooting..............................................................................................................272
General information .............................................................................................272
Contacting QIAGEN Technical Services..................................................................272
Performing a self-check on the QIAcuity instrument...................................................272

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Creating a support package with the QIAcuity instrument software ............................273
Creating a support package with the QIAcuity Software Suite ...................................277
Troubleshooting the instrument and software............................................................279
Accessing the system status and clearing errors .......................................................282
Glossary........................................................................................................................284
Appendix A – Technical Data ..........................................................................................285
Operating conditions............................................................................................285
Transport conditions .............................................................................................286
Storage conditions ...............................................................................................286
Mechanical data and hardware features.................................................................286
Declaration of conformity ......................................................................................289
Waste Electrical and Electronic Equipment (WEEE) ..................................................289
California Proposition 65......................................................................................290
Liability Clause ....................................................................................................290
Declaration list of China RoHS (SJT 11364-2014)....................................................290
Appendix B – QIAcuity Accessories..................................................................................292
Ordering information............................................................................................292
Appendix C – Informations de sécurité..............................................................................295
Utilisation appropriée ...........................................................................................295
Sécurité électrique................................................................................................297
Environnement .....................................................................................................298
Sécurité biologique ..............................................................................................298
Produits chimiques................................................................................................300
Sécurité de maintenance.......................................................................................300
Sécurité contre les rayonnements............................................................................301
Symboles sur le QIAcuity ......................................................................................301
Appendix D – Sicherheitshinweise....................................................................................302
Sachgemäße Handhabung....................................................................................302
Schutz vor Stromschlag.........................................................................................304
Umgebung ..........................................................................................................305
Biologische Sicherheit...........................................................................................306

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Chemikalien ........................................................................................................307
Wartungssicherheit...............................................................................................307
Strahlensicherheit.................................................................................................308
Symbole auf dem QIAcuity....................................................................................308
Appendix E – User management permissions.....................................................................309
Document Revision History...............................................................................................312

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Introduction
Thank you for choosing QIAcuity. We are confident it will become an integral part of your
laboratory. Before using QIAcuity, 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.
About this user manual
This user manual provides information about QIAcuity in the following sections:
1. Introduction
2. Safety Information
3. General Description
4. Installation Procedures
5. Operating Procedures
6. Maintenance Procedures
7. Troubleshooting
8. Glossary
9. Appendix A – Technical Data
10. Appendix B – QIAcuity Accessories
11. Appendix C – Consignes de sécurité (Safety Information in French)
12. Appendix D – Sicherheitshinwiese (Safety Information in German)
13. Appendix E – User management permissions
14. Document Revision History
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 QIAcuity or QIAGEN products in general, do
not hesitate to contact us.

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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
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).
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 about this user
manual. Please contact QIAGEN Technical Services.
Intended use of the QIAcuity
QIAcuity systems are designed to determine absolute amounts of target DNA in a sample by using
a digital PCR (dPCR) approach.
Digital PCR uses the procedure of end-point PCR, but splits the PCR reaction in many single partitions
in which the template is randomly distributed across all available partitions. After PCR, the target
molecule is detected by measuring the fluorescence – either of sequence specific DNA probes or of
intercalating dyes – in all positive partitions. As the template is distributed randomly, Poisson
statistics can be used to calculate the amount of target DNA per positive partition. The total amount
of target DNA in all partitions of a well is then calculated by multiplying the amount of target DNA
per partition with the number of positive partitions. Calculation of target concentration is determined
by referring back to the volume in all analyzable partitions, i.e., partitions which were filled with
reactions mix. The total number of filled partitions is identified by a fluorescent dye, present in the
reaction mix itself. Absolute quantification by dPCR eliminates the need of standard curves to
determine amounts of target DNA in a given sample.
Aside from absolute quantification, the QIAcuity software provides analysis modules for mutation
detection, genome editing analysis, copy number variation (CNV), and gene expression analysis.

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QIAcuity systems are intended to be used only in combination with QIAGEN kits indicated for use
with the QIAcuity systems such as QIAcuity Nanoplates and QIAcuity PCR Reagents for the
applications described in the kit handbooks.
If QIAcuity is used with products other than QIAGEN kits or QIAGEN assays designed for dPCR, it
is the user’s responsibility to validate the performance of such product combination for any
particular application.
The QIAcuity system is intended for use by professional users trained in molecular biological
techniques and the operation of the QIAcuity system.
The QIAcuity system is intended for molecular biology applications. This product is not intended for
the diagnosis, prevention, or treatment of a disease.

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Requirements for QIAcuity users
This table covers the general level of competence and training necessary for transportation,
installation, use, maintenance, and servicing of the QIAcuity systems.
Table 1. Requirements for QIAcuity users
Task Personnel Training and experience
Delivery No special requirements No special requirements
Installation Laboratory technicians or equivalent Appropriately trained or experienced
personnel familiar with use of
computers and automation in general
Routine use (running protocols) Laboratory technicians or equivalent Appropriately trained or experienced
personnel familiar with use of
computers and automation in general
Assay design and validation Scientist or equivalent Appropriately trained or experienced
personnel familiar with molecular
biological techniques
Dust filter replacement Laboratory technicians or equivalent Appropriately trained or experienced
personnel familiar with use of
computers and automation in general
Preventive maintenance QIAGEN service personnel or service
technicians of an authorized agent
Trained and authorized by QIAGEN
Servicing QIAGEN service personnel or service
technicians of an authorized agent
Trained and authorized by QIAGEN