Qiagen QIAcuity 911000 User manual

Sample to Insight__
April 2021
QIAcuity Safety
Information and
Installation Guide
911000, 911020, 911040, 911050
QIAGEN GmbH, QIAGEN Strasse 1, D
-40724 Hilden
1122040

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QIAcuity Safety and Installation Guide 04/2021
Contents
Introduction................................................................................................................5
About this guide............................................................................................... 6
Intended use of the QIAcuity.............................................................................. 7
Requirements for QIAcuity users ......................................................................... 8
Safety Information to Prevent Misuse and Personal and Material Damage ......................... 9
Proper use ..................................................................................................... 10
Electrical safety .............................................................................................. 12
Environment................................................................................................... 13
Biological safety............................................................................................. 14
Chemicals ..................................................................................................... 15
Maintenance safety ........................................................................................ 16
Radiation safety ............................................................................................. 16
Symbols on the QIAcuity ................................................................................. 17
General Description .................................................................................................. 18
QIAcuity Installation.................................................................................................. 20
Installation environment................................................................................... 20
Installation of AC power cord .......................................................................... 23
Installing the QIAcuity..................................................................................... 24
QIAcuity Software Suite Installation............................................................................. 27
Installing the QIAcuity Software Suite................................................................ 28
Establish a connection between the QIAcuity instrument and the QIAcuity Software
Suite ............................................................................................................. 35

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Maintenance Procedures ........................................................................................... 53
Cleaning agents............................................................................................. 54
Servicing ....................................................................................................... 58
Regular maintenance procedure of QIAcuity...................................................... 58
Periodic maintenance...................................................................................... 58
Decontaminating the QIAcuity.......................................................................... 61
Regular maintenance procedure for QIAcuity Instrument Software ........................ 61
Regular maintenance procedure for QIAcuity Software Suite ............................... 63
Troubleshooting ........................................................................................................ 65
General information........................................................................................ 65
Contacting QIAGEN Technical Services............................................................ 65
Performing a self-check on the QIAcuity instrument ............................................. 66
Creating a support package with the QIAcuity instrument software....................... 67
Creating a support package with the QIAcuity Software Suite ............................. 72
Troubleshooting the instrument and software...................................................... 74
Accessing the system status and clearing errors.................................................. 80
Appendix A – Technical Data..................................................................................... 83
Operating conditions ...................................................................................... 83
Transport conditions........................................................................................ 85
Storage conditions.......................................................................................... 85
Mechanical data and hardware features........................................................... 86
Declaration of conformity ................................................................................ 89
Waste Electrical and Electronic Equipment (WEEE)............................................. 89
California Proposition 65 ................................................................................ 90

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QIAcuity Safety and Installation Guide 04/2021
Liability Clause............................................................................................... 90
Declaration list of China RoHS (SJT 11364-2014) .............................................. 91
Document Revision History......................................................................................... 94

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Introduction
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.
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
guide. Please contact QIAGEN Technical Services.

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QIAcuity Safety and Installation Guide 04/2021
About this guide
This safety and installation guide provides information about QIAcuity in the following sections:
Intended use
Safety Information
General description
QIAcuity Installation
QIAcuity Software Suite Installation
Connecting the QIAcuity Software Suite to the QIAcuity instrument
Maintenance Procedures
Troubleshooting

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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.
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 the 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.

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QIAcuity Safety and Installation Guide 04/2021
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.
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. Competence level and training required 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 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

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Safety Information to Prevent Misuse and
Personal and Material Damage
Before using the 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.
Note: Translations of the Safety Information in French and German are available in in
Appendix C – Informations de sécurité and Appendix D – Sicherheitshinweise.
The following types of safety information appear in this manual.
WARNING
The term WARNING is used to inform you about situations that could
result in personal injury to you or other persons.
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 instrument or other equipment.
Details about these circumstances are given in a box like this one.
The advice given in this manual is intended to supplement, not supersede, the normal safety
requirements prevailing in the user’s country.

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QIAcuity Safety and Installation Guide 04/2021
Proper use
WARNING
Risk of personal injury and material damage [W1]
Improper use of the QIAcuity may cause personal injuries or damage to
the instrument. The QIAcuity must only be operated by qualified personnel
who have been appropriately trained.
Servicing of the QIAcuity must only be performed by a QIAGEN Field
Service specialist.
Perform the maintenance as described in the Maintenance Procedures section. QIAGEN
charges for repairs that are required due to incorrect maintenance.
WARNING
Risk of personal injury and material damage
[
W2]
The QIAcuity is too heavy to be lifted by one person. To avoid personal
injury or damage to the instrument, do not lift the instrument alone. The
bottom plane shall be used for lifting. Do not lift at the touchscreen.
WARNING
Risk of personal injury and material damage [W3]
Do not attempt to move the QIAcuity during operation.
CAUTION
Damage to the instrument [C1]
Avoid spilling water or chemicals onto the QIAcuity. Damage caused by
water or chemical spillage will void your warranty.
In case of emergency, power OFF the QIAcuity at the power switch located in the back of the
instrument and unplug the power cord from the power outlet.

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CAUTION Damage to the instrument [C2]
Only use QIAcuity-specific consumables with the QIAcuity. Do not use the
plates without applied top-
seals. Damage caused by use of other
consumables will void your warranty.
CAUTION
Damage to the instrument [C3]
Do not drop objects into the instrument when the plate tray is ejected.
WARNING
Risk of explosion [W7]
The QIAcuity is intended for use with reagents and substances supplied with
QIAGEN kits or other than outlined in respective Information for Use. Use of
other reagents and substances may lead to fire or explosion.
CAUTION
Damage to the instrument [C4]
Do not stack instruments and do not place items on top of the QIAcuity.
CAUTION
Damage to the instrument [C5]
Do not lean against the touchscreen when it is pulled out.

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Electrical safety
Note: Disconnect the line power cord from the power outlet before servicing.
WARNING
Electrical hazard [W8]
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 [W9]
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 in the type plate of the instrument.
WARNING
Risk of electric shock [W10]
Do not open any panels on the QIAcuity.
Risk of personal injury and material damage
Only perform maintenance that is specifically described in this user
manual.
To ensure satisfactory and safe operation of the QIAcuity, follow these guidelines:
The line power cord must be connected to a line power outlet that has a protective
conductor (earth/ground).
Do not adjust or replace internal parts of the instrument.

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Do not operate the instrument with any covers or parts removed.
If liquid has spilled inside the instrument, power OFF the instrument, disconnect it from
the power outlet, and contact QIAGEN Technical Services.
If the instrument becomes electrically unsafe, prevent other personnel from operating it, and
contact QIAGEN Technical Services.
The instrument may be electrically unsafe when:
It or the line power cord appears to be damaged.
It has been stored under unfavorable conditions for a prolonged period.
It has been subjected to severe transport stresses.
Liquids come in contact directly with electrical components of the QIAcuity.
Environment
Operating conditions
WARNING
Explosive atmosphere [W11]
The QIAcuity is not designed for use in an explosive atmosphere.
CAUTION
Damage to the instrument [C6]
Direct sunlight may bleach parts of the instrument and cause damage to
plastic parts.
The QIAcuity must be located out of direct sunlight.

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QIAcuity Safety and Installation Guide 04/2021
CAUTION
Risk of overheating [C7]
To ensure proper ventilation, maintain a minimum clearance of 10 cm at
the sides and rear of the QIAcuity.
Slits and openings that ensure the ventilation of the QIAcuity must not
be covered.
Biological safety
Specimens 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 (www.cdc.gov/labs/BMBL.html).
Samples
Samples may contain infectious agents. 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 [W12]
Some samples used with this 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, 2 pairs of gloves, and a lab coat.
The responsible body (e.g., 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 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.
Chemicals
WARNING Hazardous chemicals [W13]
Some chemicals used with this instrument may be hazardous or may
become hazardous after completion of the protocol run.
Always wear safety glasses, gloves, and a lab coat.
The responsible body (e.g., 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 Safety
Data Sheets (SDSs) or 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).

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Maintenance safety
WARNING/
CAUTION
Risk of personal injury and material damage [W14]
Only perform maintenance that is specifically described in this user
manual.
WARNING
Risk of fire [W15]
Do not allow cleaning fluid or decontamination agents to come into
contact with the electrical parts of the QIAcuity.
CAUTION Damage to the instrument [C8]
Do not use bleach, solvents, or reagents containing acids, alkalis, or
abrasives to clean the QIAcuity.
CAUTION
Damage to the instrument [C9]
Do not use spray bottles containing alcohol or disinfectant to clean
surfaces of the QIAcuity.
Radiation safety
WARNING
Risk of personal injury [W16]
Hazard Level 2 laser light: Do not stare into the light beam when using
handheld bar code scanner.

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Symbols on the QIAcuity
Symbol
Location
Description
Type plate on the back of the
instrument
CE mark for European Conformity
Type plate at the back of the
instrument
CSA listing mark for Canada and
the USA
Type plate on the back of the
instrument
RCM mark for Australia and New
Zealand
Type plate on the back of the
instrument
RoHS mark for China (the restriction
of the use of certain hazardous
substances in electrical and
electronic equipment)
Type plate on the back of the
instrument
Waste Electrical and Electronic
Equipment (WEEE) mark for Europe
Type plate on the back of the
instrument
Legal manufacturer
Type plate on the back of the
instrument
Consult instructions for use
Type plate on the back of the
instrument
See chapter Safety Information for
risks
Type plate on the back of the
instrument
Date of manufacture
On the drawer Biological hazard – some samples
used with this instrument may
contain infectious agents and must
be handled with gloves.

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QIAcuity Safety and Installation Guide 04/2021
General Description
The QIAcuity performs a fully automated processing of the QIAcuity Nanoplates, including all
necessary steps of plate priming, sealing of partitions, thermocycling, and image analysis.
Depending on the plate type, up to 24 or 96 samples per plate can be analyzed. For high
sensitivity applications, the QIAcuity Nanoplate 26K 24-well is available. The number of in
parallel processable plates depends on the instrument configuration. The QIAcuity controls all
integrated modules, including a robotic gripper for plate handling, a partitioning module, a
PCR thermocycler, and a fluorescence imaging module. For more information refer to the
QIAcuity user manual on www.qiagen.com.
Figure 1. QIAcuity Four.

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QIAGEN offers different instrument configurations. QIAcuity One as 2-plex and 5-plex version.
QIAcuity Four and QIAcuity Eight always offer 5-plex analysis. This table shows the available
channels provided in each instrument.
Table 2. QIAcuity instrument configurations
Instrument Available channels
QIAcuity One, 2-plex Green
Yellow
QIAcuity One, 5-plex Green
Yellow
Orange
Red
Crimson
QIAcuity Four Green
Yellow
Orange
Red
Crimson
QIAcuity Eight Green
Yellow
Orange
Red
Crimson

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QIAcuity Safety and Installation Guide 04/2021
QIAcuity Installation
The installation procedure of the product is recommended to be carried out by a certified
QIAGEN Field Service Specialist. A person who is familiar with the laboratory and computer
equipment should be present during the installation.
Installation environment
Site requirements
The QIAcuity must be located away of direct sunlight, away from heat sources, and away
from sources of vibration and excessive electrical interference. A vibration amplitude of the
lab bench of 6mm/s² shall not be exceeded. Placing a QIAgility or an orbital shaker next to
the instrument does not exceed this value. Refer to Appendix A – Technical Data for the
operating conditions (temperature and humidity). The site of installation should be free of
excessive drafts, excessive moisture, and excessive dust and should not be subject to large
temperature fluctuations.
Use a level workbench that is large enough and strong enough to accommodate the QIAcuity.
Refer to Appendix A – Technical Data for the weight and dimensions of the QIAcuity. Allow
at least 15 cm (5.9 in.) of free space behind and to the sides of the instrument for cooling and
cabling.
Ensure that the workbench is dry, clean, and vibration-proof and has additional space for
accessories.
The QIAcuity must be placed within approximately 1.5 m of a properly grounded (earthed)
AC power outlet. The power line to the instrument should be voltage-regulated and surge-
protected. Ensure that the QIAcuity is positioned where it is easy to access the power connector
and the power switch at the back of the instrument at all times, and that it is easy to power the
instrument OFF and disconnect it.