Page 1 July 2020 QIAcuity User Manual 911000, 911020, 911040, 911050 QIAGEN GmbH, QIAGEN Strasse 1, D-40724 Hilden 1121818EN Sample to Insight__...
Page 2 QIAcuity User Manual 07/2020...
Page 3: Table Of Contents
Contents Introduction ........................6 About this user manual ..................... 6 Intended use of the QIAcuity ..................8 Requirements for QIAcuity users ................. 9 Safety Information ......................10 Proper use ......................10 Electrical safety ......................12 Environment......................13 Biological safety ....................13 Chemicals ......................14 Maintenance safety ....................15 Radiation safety .....................15 Symbols on the QIAcuity ..................16 General Description ......................17...
Page 4 Regular maintenance procedure for QIAcuity Software Suite ........195 Troubleshooting ......................196 General information .....................196 Contacting QIAGEN Technical Services ..............196 Performing a self-check on the QIAcuity instrument ...........196 Creating a support package with the QIAcuity instrument software ......197 Creating a support package with the QIAcuity Software Suite ........200 Troubleshooting the instrument and software ............202...
Page 5 Storage conditions ....................210 Mechanical data and hardware features..............210 Declaration of conformity ..................213 Waste Electrical and Electronic Equipment (WEEE) ..........213 California Proposition 65 ..................214 Liability Clause ....................214 Appendix B – QIAcuity Accessories ..................215 Ordering information ....................215 Appendix C – Informations de sécurité ................218 Utilisation appropriée ...................218 Sécurité...
Page 6: Introduction
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.
Page 7 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.
Page 8: Intended Use Of The Qiacuity
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.
Page 9: Requirements For Qiacuity Users
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 Trained and authorized by QIAGEN technicians of an authorized agent Servicing QIAGEN service personnel or service...
Page 10: Safety Information
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.
Page 11 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...
Page 12: Electrical Safety
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.
Page 13: Environment
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. ...
Page 14: Chemicals
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. 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.
Page 15: Maintenance Safety
Maintenance safety WARNING/ Risk of personal injury and material damage [W14] CAUTION Only perform maintenance that is specifically described in this user manual. Risk of fire [W15] WARNING Do not allow cleaning fluid or decontamination agents to come into contact with the electrical parts of the QIAcuity.
Page 16: Symbols On The Qiacuity
Symbols on the QIAcuity Symbol Location Description Type plate on the back of the CE mark for European Conformity instrument Type plate at the back of the CSA listing mark for Canada and the instrument Type plate on the back of the RCM mark for Australia and New instrument Zealand...
Page 17: General Description
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.
Page 18 Scheme of filling and partitioning of a well. Principle of priming and rolling to allow partitioning of the wells. Thermocycling: The second step and module is a high accuracy plate thermocycler that performs the polymerase chain reaction. The cycling profile can be set in the QIAcuity Software Suite or the instrument software.
Page 19: External Features Of Qiacuity
Scheme of positive (green) and negative (blue) partitions after imaging. External features of QIAcuity Touchscreen The QIAcuity is controlled using a swivel-mounted touchscreen. To adjust the angle of the touchscreen, pull gently at the bottom edge. The touchscreen enables the user to see an overview of all plate slots and the corresponding process steps and remaining times.
Page 20 USB stick. The USB ports can also be used to plug in an external bar code reader or a mouse/keyboard. Important: We recommend using QIAGEN USB sticks only to ensure full compatibility. Important: Do not remove the USB stick while downloading or transferring data or software to or from the instrument.
Page 21 WARNING Electrical hazard [W17] 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.
Page 22: Thermal Cycler
Back view of the QIAcuity. External hand scanner The QIAcuity Four and Eight instrument is equipped with a barcode scanner, which enables the user to scan the plate ID before loading. For QIAcuity One, a barcode scanner is available as accessory.
Page 23: Optical System
Optical system The optical system of the QIAcuity is a camera based fluorescence microscopy system. The excitation source for the fluorescence dyes is a high-power white LED. This source in combination with a specific excitation filter is used to illuminate a whole well at a time. The fluorophores in the single partitions absorb that light and emit light that is being filtered by a detection filter, collected and imaged through an objective lens on a CMOS-camera chip (see image below for a detailed overview of the components).
Page 24: Installation Procedure
This section provides instructions on unpacking, packing, and installing the QIAcuity. 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.
Page 25 CAUTION Risk of overheating [C9] 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. Risk of personal injury and material damage WARNING [W2] The QIAcuity is too heavy to be lifted by one person.
Page 26 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 Electrical hazard [W8]...
Page 27: Installation Of Ac Power Cord
Note: Before unpacking the QIAcuity, move the package to the site of installation and check that the arrows on the package point upward. In addition, check whether the package is damaged. In case of damage, stop here and contact QIAGEN Technical Services. 1. Cut the straps securing the packaging to the shipping pallet.
Page 28: Packing The Qiacuity
QIAGEN Technical Services. 7. Check that the QIAcuity is not damaged and that there are no loose parts. If anything is damaged, contact QIAGEN Technical Services. Make sure that the QIAcuity has equilibrated to ambient temperature before operating it. 8. Retain the package in case you need to transport the QIAcuity in the future. Refer to Packing the QIAcuity for more details.
Page 29: Installing The Qiacuity
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. 5. Place the accessories into the black foam lid. Important: The power cord must be packed in an air cushion bags.
Page 30 Back of QIAcuity Connecting the power cord to the back of the QIAcuity 1. Remove the power cord from the foam packing material on top of the QIAcuity. Note: Only use the power cord that is supplied with the QIAcuity. 2.
Page 31: Installing The Qiacuity Software Suite
3. If there is an initialization error, retry the initialization process by turning the instrument off and on again. If the problem persists, see Troubleshooting the instrument and software or contact QIAGEN Technical Services. Note: The instrument must be turned off at least once a week.
Page 32 The QIAcuitySuite.msi package needed for the installation of the QIAcuity Software Suite is provided on the USB drive that comes with the QIAcuity. Alternatively, you can download the QIAcuitySuite.msi package from www.qiagen.com. To install the QIAcuity Software Suite on the notebook, follow the steps below.
Page 33 3. Check the I accept the terms in the License Agreement box in the End-User License Agreement window and click Next. QIAcuity User Manual 07/2020...
Page 34 4. Click Next in Destination Folder window. QIAcuity User Manual 07/2020...
Page 35 5. Click Install to start the installation. 6. In the prompt window asking you if you allow changes to your device, click Yes. QIAcuity User Manual 07/2020...
Page 36 Note: During installation, some command line windows may appear in the foreground. Do not close any of them. 7. When the installation is completed, click Finish. QIAcuity User Manual 07/2020...
Page 37 8. In the local host site that says the site is not secure, click Details. 9. Click Go on to the webpage. You are directed to the QIAcuity Software Suite login screen. QIAcuity User Manual 07/2020...
Page 38: Uninstalling The Qiacuity Software Suite
Uninstalling the QIAcuity Software Suite To uninstall the QIAcuity Software Suite from your system, follow the steps below. 1. Go to the Control Panel app. QIAcuity User Manual 07/2020...
Page 39 2. Select Uninstall a program from the Programs menu: 3. Select QIAcuity Software Suite from the list, and click Uninstall. 4. Click Yes to confirm. 5. In the prompt window that says a reboot is required to complete the setup, click OK. QIAcuity User Manual 07/2020...
Page 40 6. In the prompt window asking you if you allow changes to your device, click Yes. QIAcuity Software Suite uninstallation process starts. 7. After the uninstallation, click Yes in the window asking to restart the device. QIAcuity User Manual 07/2020...
Page 41 8. After restarting, navigate to Control Panel > Programs > Uninstall a program. Select PostgreSQL 11, then click Uninstall/Change. 9. In the prompt window asking you if you allow changes to your device, click Yes. QIAcuity User Manual 07/2020...
Page 42 10. Click Yes in the error message window to uninstall PostgreSQL 11. 11. Go to C:\Program Files (x86). Right-click QIAcuity Software Suite and click Delete. This removes the installation folder from the Program Files directory. QIAcuity User Manual 07/2020...
Page 43: Establishing A Connection Between The Qiacuity Instrument And The Qiacuity Software Suite
Establishing a connection between the QIAcuity instrument and the QIAcuity Software Suite The QIAcuity instrument needs to be connected to the QIAcuity Software Suite to enable the exchange of data. This also enables the QIAcuity Software Suite to set up plates, analyze results, and monitor the status of runs in real time.
Page 44 2. Click Network and Internet (if not available proceed to the next step). 3. Click Network and Sharing Center. 4. On the left pane, click Change adapter settings. 5. Right-click the ethernet network adapter and select Properties. 6. Select Internet Protocol Version 4 (TCP/IPv4) and click Properties. QIAcuity User Manual 07/2020...
Page 45 7. Select Obtain an IP address automatically. If your organization does not provide DNS details, select Obtain DNS server address automatically as well. Click OK, then Close. Optional: You can check if the addresses have been assigned properly by following the steps below.
Page 46 Follow the steps below to configure the QIAcuity instrument. 1. On the toolbar, tap Configuration. 2. Select the Ethernet tab. 3. Check the DHCP enabled box. If you check this box, the IP address and MAC address fields are disabled. The assigned IP and MAC addresses of device are displayed in the IP address and MAC address fields.
Page 47 Configuring a direct cable connection between the QIAcuity instrument and the QIAcuity Software Suite Note: Before you start, ensure that the QIAcuity instrument and the notebook are connected with an Ethernet cable. Follow the steps below to configure the notebook running the QIAcuity Software Suite. 1.
Page 48 4. On the left pane, click Change adapter settings. 5. Right-click the ethernet network adapter and select the Properties option. 6. Select Internet Protocol Version 4 (TCP/IPv4) and click Properties: QIAcuity User Manual 07/2020...
Page 49 7. Select Use the following IP address. Enter the following information: IP address: Enter 192.168.1.1.  Subnet mask: Enter 255.255.255.0.  Default gateway: Enter 192.168.1.254.  Preferred DNS server: Enter the DNS server address.  Alternative DNS server: Enter the alternative DNS server address. ...
Page 50 Follow the steps below to configure the QIAcuity instrument. 1. On the toolbar, tap Configuration. 2. Select the Ethernet tab. 3. Ensure that the DHCP enabled box is not checked. Enter the following information: IP address: Enter 192.168.1.2.  Subnet mask: Enter 255.255.255.0. ...
Page 51 The QIAcuity is already prepared to connect the instrument via Wi-Fi to a network and to the QIAGEN Q-Base once available. Connecting via Wi-Fi requires a QIAcuity Connectivity Package which will be available separately at a later time. See www.qiagen.com for more information. 1. On the Home screen, tap Configuration.
Page 52 3. Select your preferred access point from the Available networks list. Details of the selected network are shown on the right side of the list. 4. If the network requires a password, enter the password in the Password field using the on- screen keyboard.
Page 53 3. Enter the URL in the Software Suite URL field. The Suite URL has the following format: https://<IP address of Suite Server>:8687/instrument/v0/ Note: To get the IP address of the Suite Server, the instrument must be connected to the Suite Server.
Page 54 4. If you want to configure the proxy settings in your network configuration, clear the Bypass proxy box and enter the following information: Proxy Server: Enter the proxy server address.  Proxy Port: Enter the port address.  User Name: Enter the username. ...
Page 55: Getting Started With The Qiacuity
Getting started with the QIAcuity Configuration of the QIAcuity If you are using QIAcuity for the first time, we recommend that you define the required settings. Other settings can be changed later, when needed. For more information about using the touchscreen and software, refer to Operating the QIAcuity instrument .
Page 56 Note: To return to the Home screen from another screen, tap Running Status. Setting basic system data This section describes how to set your preferred name for the instrument and how to adjust the date and time settings. To set your preferred QIAcuity name: 1.
Page 57 Managing users The QIAcuity requires users to log in before accessing instrument functionalities. Each user must have a user account with an appropriate role assigned to it. The QIAcuity supports two user roles – Administrator and Operator. Each role has different access rights to QIAcuity functions. Table 4.
Page 58 Adding a new user account Note: Only administrators can create new user accounts. 1. On your Home screen, tap Configuration. 2. Tap Users. The Users tab shows all existing user accounts. 3. Tap New. The Create new user dialog appears. QIAcuity User Manual 07/2020...
Page 59 4. Tap the corresponding field to enter the following information using the on-screen keyboard: Login: Enter a username for the new user. The username is used to log into the  instrument. You can enter up to 30 characters in this field. Name: Enter the first name of the user.
Page 60 4. Tap the Name field to change the first name of the user. 5. Tap the Surname field to change the last name of the user. 6. To change the role or roles of the user tap the checkbox next to the role. 7.
Page 61 Removing a user account Note: Only administrators can remove user accounts. An Admin user cannot delete his own user account. This ensures that at any time at least one user with admin rights is configured. 1. On your Home screen, tap Configuration. 2.
Page 62 Changing your own password To change your own password, follow the steps below. 1. On your Home screen, tap Configuration. 2. Tap Users. If you are an administrator, the Users tab shows all existing user accounts. If you are an operator, the Users tab only shows your own account. 3.
Page 63 6. To save your new password, tap Save. To discard all changes, tap Cancel. Updating the software Visit www.qiagen.com and go to Software section of the QIAcuity product page to check if an updated software version is available for download.
Page 64 Note: If the USB drive is empty, no information is displayed in the Device Info (USB) pane. 4. Tap Update software to proceed. The Update Flash Controller Software and Firmware window is shown. Tap Start to begin the software update or tap Cancel to return to the previous window. QIAcuity User Manual 07/2020...
Page 65 Tap Cancel to stop the process. Remove the USB drive and tap Reboot to restart the instrument. If the QIAcuity does not function after an unsuccessful software update, contact QIAGEN Technical Services. 5. After the software update files are copied, tap Reboot to restart the instrument.
Page 66 Synchronizing labware with the QIAcuity Software Suite Information about the labware used by the QIAcuity can be downloaded from the Software Suite. The labware data is synchronized automatically when the instrument is turned on. You can also synchronize it manually by clicking Tools and selecting Labware Sync. The labware is then downloaded and updated.
Page 67 3. Tap Labware sync. The Labware synchronization dialog box appears. The progress of the download is shown in the dialog box. Once the synchronization is complete, tap OK to finish the process. QIAcuity User Manual 07/2020...
Page 68: Operating The Qiacuity Instrument
Operating the QIAcuity instrument The QIAcuity is operated through a touchscreen. Elements of the QIAcuity user interface are shown in the following table. Table 5. QIAcuity interface elements Button/Icon Function Starts the run Stops the run Starts runs on all loaded plates Stops all runs Closes an open tray Ejects selected tray...
Page 69 Entering text and numbers To enter text or numbers, tap the corresponding field. An on-screen keyboard is displayed on the touchscreen. In some cases, the value required in a text field must meet a specific criterion. If required, the criteria are specified in the corresponding input window.
Page 70 Note: For all text fields, a handheld scanner plugged into one of the USB-ports can be used to scan 1D barcodes. Buttons and icons related to the on-screen keyboards are shown in the following table. Table 6. On-screen keypad buttons and icons Button/Icon Function Removes one character to the left...
Page 71 3. Tap Login. The Home screen displays. Note: If the username does not match the password or if the username does not exist, an error message is displayed on the screen. Re-enter the correct credentials in the Username and Password fields. Setting up a run Before starting a run, at least one plate must be created, and its name, plate type and dPCR parameters must be defined.
Page 72 Note: Loading and unloading plates during a run is supported by QIAcuity Eight and QIAcuity Four. To learn more about continuous loading and unloading, refer to Continuous loading and unloading of plates. To load a tray and to start a run, follow these steps: 1.
Page 73 3. Tap Close Tray or press the physical button on the instrument to close the tray. The instrument scans the barcodes on the plates. The instrument detects the availability of the plate and the label of the corresponding pane changes to Plate is detected. If the barcode matches to an existing experiment in the Software Suite, the loaded plate pane displays the defined run setup and can be started.
Page 74 Configuring a plate and starting a run You can configure a plate before or after it has been loaded to the instrument. Note: A plate can only be configured before a run starts. Changes to the configuration cannot be made after the start of a run. To start the configuration of a plate that has been loaded into the instrument, follow these steps: 1.
Page 75 To start the configuration of a plate that has not been loaded into the instrument, follow these steps: 1. On the Home (Running status) screen, tap New Plate. 2. To input the barcode manually, tap the Barcode field. To scan the barcode using the external USB scanner, tap Scan.
Page 76 In the Duration field, enter the cycling duration for the plate. Tap Add temperature step. 5. If you want to modify the temperature steps, refer to these steps: To edit or delete a temperature step, tap the More icon, then tap Edit or Delete. ...
Page 77 In the Imaging tab, select the applicable channel, then enter the exposure duration and gain in the Exposure duration and Gain fields. To include more steps in the run, tap the Add icon, then select the applicable step. Provide the required information for the step. Repeat this step if more steps are needed for the run.
Page 78 To link the barcode to a defined plate in the Software Suite, that has no barcode defined, follow these steps: 1. Tap the Link icon. 2. In the Select Plate dialog box, select the plate that you want to link to the barcode of the loaded plate.
Page 79 Tracking the run status Once the run has started, you can track the status of the run. The plate that the QIAcuity is currently working with is distinguishable through the following elements: The Running status is displayed in the pane. ...
Page 80 To view information about the individual steps of the run, tap dPCR Parameter, then tap the step which details you want to view. The instrument shows the status of each step of the run, and the remaining time of the current step. You can also view the parameters defined for each step. Table 7 shows the meaning of each status icon that are shown in the dPCR parameter step.
Page 81 Table 8. dPCR step status icon Icon Status The step is successfully finished. The step is being executed. The step is pending, and its execution will start after the current step is done. The step failed. When the run is finished, the status of the run changes to Done and the Eject button becomes available.
Page 82 Note: If the slot where the new plate is placed is also used by a plate that is in a different module, an error message is shown on the screen, and the new plate must be moved to a free slot. The drawer opens automatically, which can take up to two minutes.
Page 83 steps in Plate configuration. If you want to use the Software Suite, refer to Operating the QIAcuity Software Suite Note: To modify a plate that was already used, you must remove it from the instrument and load it again. This ensures that the plate is unlocked and ready for modifications. Editing the run schedule Note: Editing the run schedule is only possible on QIAcuity Eight and QIAcuity Four.
Page 84 2. Tap the row corresponding to the plate that you want to move. 3. Perform one of the following actions: Tap Move up to move the plate run to an earlier position.  Tap Move down to move the plate run to a later position. ...
Page 85 Logging out Note: If a run is processing, you can still access its status, even if you log out of the instrument. For more information, refer to Accessing the run status when you are logged out. To log out of the instrument, follow these steps: 1.
Page 86 Accessing the run status when you are logged out After you log out, the Login screen is displayed on the QIAcuity display. To view the run status of an ongoing run, tap Running status. The Running status screen is displayed in view-only mode. All functions are disabled.
Page 87: Operating The Qiacuity Software Suite
Operating the QIAcuity Software Suite Getting started This section describes the workspace within the QIAcuity Software Suite, its basic concepts, and the general software use. Software workspace Main toolbar The main toolbar shows navigation items. Clicking on the icon navigates to the overview of the selected area.
Page 88 If you want to perform an experiment multiple times, you can create templates to enable a faster set up of plates. See section Setting up an experiment and section Managing your templates to get more information. To operate the QIAcuity Software Suite, a free disk space is needed. See Regular maintenance procedure of the QIAcuity for more information.
Page 89 Information bar The information bar located at the bottom of the screen displays the software version. Concepts of the QIAcuity Software Suite User management The QIAcuity Software Suite requires users to log in before accessing instrument functionalities. Each user must have a user account with an appropriate role assigned to it. The QIAcuity Software Suite supports two user roles –...
Page 90 Table 10. Access rights for Software Suite user roles Function Administrator role Operator role Plates environment Templates environment Disk monitor environment User management environment Configuration environment Change password Edit profile Adding a new user Note: Only administrators can add new users. To add a new user, follow the steps below.
Page 91 3. Enter a username for the new user in the Login field. This username is used to log into the Software Suite. Note: There are a set of login names that are reserved for special users. It cannot be selected by the Administrator when the new user is created.
Page 92 Removing a user account Note: Only administrators can remove user accounts. An administrator cannot remove his own user account. This ensures that at any time, at least one user with admin rights is configured. To remove a user account, follow the steps below. 1.
Page 93 4. Enter your password in the Admin password field. This action is needed to confirm your right to change the password of another user. 5. Enter the new password in the User new password and Repeat user new password fields. Log-in screen The main toolbar shows which user is currently logged-in.
Page 94 2. Enter the current password in the Current password field and the new password in the New password field. In the Confirm password field, enter the same password you specified in the New password field. Click Save to change the password. 3.
Page 95 Displaying errors, warnings, and additional information The QIAcuity Software Suite displays errors, warnings, and additional information messages throughout the experiment to prompt you to perform the user to perform a required action. Table 12. Messages displayed in QIAcuity Software Suite Priority level Type Color...
Page 96 Information message At certain fields in the experiment, you can view additional information regarding the required data to be entered on a field. Fields with information messages are marked with icon. Clicking this icon displays a text box that provides additional information about the data needed in the field. No user interaction is required to proceed with this step.
Page 97: Setting Up An Experiment
Setting up an experiment This section provides information about the steps required to set up a new experiment: Creating a new plate 1. Click Plates in the main toolbar to enter the plates environment. 2. Click New Plate. 3. Refer to Table 13 to provide the following required information in each tab: QIAcuity User Manual 07/2020...
Page 98 Table 13. Required steps in creating a plate Steps General data Enter the basic information about the plate:  Plate name  Plate type  Description  Labels  Barcode dPCR parameters Specify the following information:  Priming profile  Cycling ...
Page 99: Defining General Data
Table continued from previous page Table 13 (cont). Required steps in creating a plate Steps Plate layout Provide the following information:  Add reaction mix  Mark as blank  Add sample  Add control  Add NTC Defining General Data In the General Data tab, you can specify the basic information about the plate.
Page 100 Table 14. General data tab Field Field Help Plate name Specify the name of the plate. Plate type Select the plate type from the list. You can select Nanoplate 26K 24-well, Nanoplate 8.5K 24-well, or Nanoplate 8.5K 96-well. Description Enter a descriptive information about your experiment. Labels Add labels to your plate to help you categorize your experiments.
Page 101 Cycling tab You can define the temperature profile of your experiment in the Cycling tab. To do this, follow these steps: 1. In the Temperature field, specify the temperature of the step, then specify the duration of the temperature step in the Duration field. 2.
Page 102 The Imaging tab enables you to set the respective exposure duration and gain value for each channel. The channel options depend on the connected instrument. QIAGEN offers QIAcuity One in 2-plex and 5-plex version. QIAcuity Four and QIAcuity Eight offer 5-plex analysis. The following table shows the available channels provided in each instrument.
Page 103 The following actions can be performed when your run is finished: To reimage the plate with different settings, click +, then select Imaging.  To rerun the plate with additional cycles, click +, then select Cycling + Imaging  Important: After a run is finished, remove the plate from the instrument before adding a new imaging or cycling + imaging step.
Page 104 To create a new reaction mix: 1. Click New Reaction Mix. The New Reaction Mix window appears. 2. Enter the name of the reaction mix in the Reaction mix name field. The name must be unique and must not contain any special characters. You can enter up to 100 characters in this field. 3.
Page 105 5. Select the channel from the channel list where your target is detected. Optional: Select the dye of the target from the dye list. Selecting a dye automatically sets the associated channel in the Channel list. 6. If the target is an internal control, check the Internal control box. Note: Clicking the trash icon deletes all entries in the corresponding row.
Page 106 Amount: Enter the number of samples that shall have the same sample name. They will  automatically be numbered behind the sample name with 01, 02, 03 etc. Description: Specify a description for your sample.  3. Click Create. The sample(s) is / are added to your database and can be used for your experiments. QIAcuity User Manual 07/2020...
Page 107 Adding Controls and Non Template Controls You can add positive or negative controls to your experiments. To add controls: 1. Click the Controls tab. 2. Enter the name of your control in the Control Name field. 3. Click Add Control. The control is added to your database and can be used for your experiment.
Page 108 Defining plate layouts To define the plate layout, you must add reaction mix, samples, and controls to your plate. Adding a reaction mix to the plate 1. Left-click the well you want to mark. 2. Left-click the + icon, then select Add reaction mix or Mark as blank. The Add reaction mix window appears.
Page 109 Note: To edit or remove the reaction mix from the well, right-click the well and select Edit reaction mix or Remove reaction mix. You can also remove the reaction mix from the well by clicking the icon and select Remove reaction mix. Adding samples to the plate 1.
Page 110 Adding controls to the plate 1. On a marked well, click the icon or right-click the well. Note: You can also mark more than one well if you want to assign a control to multiple wells. 2. Click Add control. The Add Control window appears.
Page 111 Adding NTCs to the plate 1. On a marked well, left-click the icon or right-click the well. Note: You can also mark more than one well if you want to assign a Non-Template Control to multiple wells. 2. Click Add NTC. The Add Non-Template Control window appears.
Page 112 and select Remove NTC. To remove the NTC and the reaction mix from the well, select Clear well. List view The list view in the Plate Layout tab displays a detailed overview about your plate setup. You can modify this view by sorting and filtering: Sort by rows or columns ...
Page 113 The data needs to be entered and saved in the right format, therefore a CSV template is provided for download which helps you to enter your data in the correct format. Click CSV import/ export then click Download CSV template. Note: CSV import requires a comma-separated csv file.
Page 114 2. On a specific plate, click the three-dotted button. The context menu provides an option to edit, delete or analyze the plate. It also points you to the existing reports and enables you to export the plate. When the selected plate is currently running, you can see the run status and the respective plate details.
Page 115 Filtering Click the calendar symbol beside Time Frame to limit the overview results to plates modified within a specific period. A window appears to enable you to select or enter a specific time frame depending on the results you want to see in the overview. Click Apply to filter the results. Export and Import plate data To archive your data and free-up disk space, you can export a plate as zip file.
Page 116 If you want to import a plate again, click Import Plate in the plate overview. A new window appears where you can import plate data by uploading the zip file. Click Import and the plate is added to the plate overview. Note: An already existing plate cannot be imported again.
Page 117: Setting Up Templates
Setting up templates You can create templates to set up your experiments. You can create a new template or use an existing plate and save it as template. Creating a new template 1. In the Main Toolbar, click Templates, then click New template. The Create New Template window appears.
Page 118 Note: Click Already existing Plate Templates to display an overview of the existing plate templates. Using a template to create a new plate 1. In the Main toolbar, click Plates, then click New Plate. 2. Click Plate templates, then click Import template. The Import Plate Template window appears with all existing templates.
Page 119 3. Select an existing template, then click Import. All information in the selected template is automatically transferred to the new plate setup. Managing your templates To enter the Templates environment, click Templates from the Main toolbar. The overview screen lists all existing templates. On a specific template, click the three-dotted button to open a context menu that provides an option to edit, delete or use the template in a new plate.
Page 120: Analysis
Analysis The QIAcuity Software Suite enables you to analyze plates that have been processed by the instrument. The following analysis options are available in the software: Absolute Quantification  Mutation Detection  Genome Editing  Copy Number Variation  Gene Expression ...
Page 121 Note: Errors affecting single wells are indicated by a symbol in the affected well. Try reimaging the plate with different exposure and/or gain settings. If the error persists, create a support package and contact QIAGEN Technical Services. QIAcuity User Manual 07/2020...
Page 122 Image quality control The fluorescence signal in the reference channel is measured to determine the number of valid partitions in a well. Differences in the signal intensities between partitions are normalized and the fluorescence signals in the target channels are corrected accordingly. If the fluorescence signal is saturated in too many partitions of a well in a target channel, a warning message will be shown to the customer.
Page 123 Invalidation of images In rare cases it can happen, that the image quality is too low and the image cannot be used for further analysis. A message is shown to the customer that some wells have been invalidated. Those wells are greyed out in the plate layout and cannot be used for the result analysis. In case more than one imaging step has been done, the imaging step where the low signal quality occurred is marked in red and the message is shown when moving the mouse over the camera icon.
Page 124 Reasons for the invalidation of an image are: Too less fluorescence signal, e.g. when the Nanoplate was re-imaged after a long storage  period (see Operating plates for information about the storage of plates) Vibration during the imaging process can lead to blurry images. If the image of the reference ...
Page 125 Dust and other particles Dust and other particles like hairs or strands are detected by the QIAcuity Software Suite and are removed from the images. This figure shows an example of a well before and after dust / other particles correction. Raw image of a well showing dust particles (marked with red circles) QIAcuity User Manual 07/2020...
Page 126 Signal map of the dust-corrected image In case the images still show dust particles or other particles after the correction, the recommendation is to unload the plate, wipe the plate with a lint-free tissue and to re-image the plate. Low amplification areas In case of low amplification areas, the fluorescence signal in the target channels is less pronounced or not detectable in certain areas of the well.
Page 127 Signal map of an image with blacked-out low amplification areas Areas of bad filling Incorrect pipetting or sealing can lead to areas of the well which are not filled with reaction mix. Those areas affect the reference channel as well as the target channels and reduce the number of valid partitions.
Page 128 Signal map of an image showing areas of bad filling Crosstalk Correction algorithm Depending on the optical configuration of your QIAcuity instrument, you can detect up to two or five fluorescent channels. To compensate the spectral overlap between the fluorescent dyes, a crosstalk correction algorithm is implemented in the QIAcuity Software Suite.
Page 129 General analysis options Selecting wells for analysis To select multiple wells at the same time, click the individual wells or click one well then drag  your mouse until all wells are selected. To select all wells, click Select all. ...
Page 130 Multiple imaging steps If the plate was configured with multiple imaging steps, you can select the one used for analysis. To select the imaging step, click one of the available boxes indicated by this icon: . The channels that were activated in the selected imaging step are shown below the imaging step buttons, along with the duration and gain.
Page 131 Diagram options There are several tools related to the diagrams and charts that enable you to adjust the view and download the chart you want to view. To access the tools, point to a diagram. Table 16 shows the toolbar buttons and their corresponding functions. Table 16.
Page 132 Example of a range slider below a chart. The highlighted area of the slider shows the portion of the chart that is currently displayed. The gray part of the slider is a preview of the rest of the chart. To view another part of a diagram, click the highlighted area of the slider and drag to the part that you want to view.
Page 133 2. To select the analysis type, click Target or Channel. If there are no reaction mixes available on the plate, the Target button is disabled. 3. To analyze the plate by targets, select the targets from the Select Targets list. You can select one or more targets from the list.
Page 134 List tab for absolute quantification The List tab contains a table with an overview of the analyzed wells. The following columns are available in the table: Well identifier like A1, B2  Reaction mix – This column contains the icon and the name of the reaction mix. ...
Page 135 Note: When creating a report for this plate, the complete result list is included in the report if user selects it in the report configurator. For more information on reports see section Reports. Replicates of a sample are identified by having the same reaction mix and the same sample name. Replicates are detected automatically when the user assigns a sample to a well.
Page 136 On the right side above the table there is a checkbox which allows the user to show mean values for replicates in addition. By default, the button is unchecked, and results are displayed without mean values. When the button is checked the list still shows independent rows for each selected well, but replicates are grouped together.
Page 137 The title of a signal map shows the channel name and in case that more than one well is selected also the number of selected wells. When the user hovers with the mouse over a well, a tooltip is shown informing about the label of the given well and, if defined, about the associated target.
Page 138 Zoom window for a well image of the reference channel. Heatmap tab for absolute quantification The Heatmap tab shows the concentration of the selected targets or channels in each well. The values of all selected wells are also displayed in this tab. Values for disabled wells are not displayed.
Page 139 Showing the mean concentration values for replicates in the concentration view click Show mean values for replicates. Mean values are not supported in the partition view. Therefore, the related check box is greyed out in the partition view and a meaningful information message is shown to the user.
Page 140 The partitions heatmap of a selected target. To add any of the heatmaps to the report, click Add to report next to the relevant diagram. For more information on reports, see section . Histogram tab for absolute quantification The Histogram tab displays graphs that visualize the fluorescence values of selected wells for the selected target or channel.
Page 141 The y-axis scale can be modified using the buttons located below each graph. The buttons are visible when you hold the pointer over a graph. To view the values on a linear scale, click lin. To view the values on a logarithmic scale, click log10. Furthermore, the user can change the range of the x-axis by modifying the upper value of the fluorescence intensity on the x-axis.
Page 142 The Histogram tab. To add any of the histograms to the report, click Add to report next to the relevant diagram. For more information on reports, see section .Reference Channel The Software Suite also provides a histogram for the reference channel, which is hidden by default. To view the histogram for the reference channel in addition, click Show reference channel.
Page 143 Lasso mode for partition assignment Alternative of changing threshold values the user can assign partitions using a free hand selection in the 2D Scatterplot view (Lasso mode). When the user marked points by lasso for two channels or targets all thresholds on histogram for them disappear and can’t be modified before switching back to threshold mode using the auto threshold button.
Page 144 A 1D Scatterplot view has two axes. The x-axis represents the analyzed partitions, while the y-axis represents the relative fluorescence intensity of each partition. A 1D Scatterplot view concentrates the diagrams for each selected well in a horizontal way separated by a vertical line (column indicator). For each well diagram a header is shown indicating the well coordination on the plate.
Page 145 4. Click Recalculate to trigger the re-analysis of data and to close the window. Click Cancel to close the window without any changes. Note: To add a single well diagram to the report, click Add to report. For more information on reports, see Reports.
Page 146 The 1D Scatterplot view with Common threshold. To add any of the 1D Scatterplot views to the report, click Add to report next to the relevant view. For more information on reports, see . Reference channel The Software Suite also provides a 1D Scatterplot view for the reference channel, which is hidden by default.
Page 147 1D Scatterplot for the reference channel. Lasso mode for partition assignment Alternative of changing threshold values the user can assign partitions using a free hand selection in the 2D Scatterplot view (Lasso mode). When the user marked points by lasso for two channels or targets all thresholds on 1D Scatterplot for them disappear and can’t be modified before switching back to threshold mode using the auto threshold button.
Page 148 with the maximal values presented from 0 to maximal fluorescence intensity of selected channel measured. The user can change the range of the x- and the y-axis by modifying the upper value of the fluorescence intensity on the x- and y-axis. For this the user clicks on top of the y-axis / on the right of the x-axis, which opens a text box each.
Page 149 2D Scatterplot view with 2 Common thresholds. Assigning partitions to a group using free hand (Lasso mode) The user can select partition measurement dots with a free hand mode, so that he can use a more precise assign partitions group they should belong...
Page 150 2D Scatterplot – Lasso mode – Group selection before free-hand assignment. Use the Auto-threshold button for each axis to re-set the threshold to the values, which is calculated by the analysis algorithm for each well. Click the Recalculate button to trigger the re-analysis of data.
Page 151 bars. After a concentration diagram loads, the first 32 wells are shown in the diagram. To view other wells, use the slider located below the diagram. To view the mean values for replicates on the diagram, click Show mean values for replicates. In this case one bar is shown for a replicate group showing the mean concentration value and the mean CI value of the replicate group.
Page 152 Setting up a mutation detection analysis 1. Click the relevant wells in the Select wells pane. For more information, see Selecting wells for analysis. 2. Select the applicable wild type target from the Wild type target list. 3. Select the applicable mutant target from the Mutant target list. 4.
Page 153 CI (95%) – This column shows the value of the confidence interval at a 95% confidence level.  Mutation fraction – This column shows the Mutant fraction value in %  CI (95%) – This column shows the value of the confidence interval for mutant fraction at a 95% ...
Page 154 The replicate results are shown in one row per replicate group. Individual replicate results are not available. The checkbox which allows the user to show mean values for replicates is checked and disabled. To export the list view information as .csv file, click Export CSV. Note: Creating a report for this plate, the result list is automatically included in this report as soon as at least one dedicated diagram for mutation detection (heatmap, point diagram, Concentration diagram) is selected to be included.
Page 155 To add the heatmap diagram to the report, click Add to report. For more information on reports, see section Reports. Point diagram tab for mutation detection The Point diagram tab shows a diagram that displays the percentage of mutant fractions in each analyzed well.
Page 156 mean mutant fraction value of the replicates. When there are no replicates within selected wells for mutant target the points don't change. The corresponding well IDs of the replicates are shown on the x axis. This is also applied in same way by default to the view where targets are in different reaction mixes.
Page 157 Each combination of wild type target and mutant target in one sample throughout the selected wells is represented in the diagram with one bar showing the concentration value together with the confidence interval. To view detailed information, hold the mouse pointer over its corresponding bar.
Page 158 Genome editing The Genome editing tab contains views which provide insight into the number of edited genomes in analyzed wells. The analysis results are put into list views, heatmaps, point diagrams, and concentration diagrams Note: Saving genome editing tests is not yet provided Setting up a genome editing analysis 1.
Page 159 Concentration (copies/ul) – This column shows the concentration assigned to each target or  channel. CI (95%) – This column shows the value of the confidence interval at a 95% confidence level.  Edited fraction – This column shows the edited fraction for the edited target as percentage. ...
Page 160 The replicate results are shown in one row per replicate group. Individual replicate results are not available. The checkbox which allows the user to show mean values for replicates is checked and disabled. To export the list view information as .cv file, click Exports CSV. Note: Creating a report for this plate, the result list is automatically included in this report as soon as at least one dedicated diagram for genome editing (heatmap, point diagram, Concentration diagram) is selected to be included.
Page 161 Point diagram tab for genome editing The Point diagram tab shows a diagram that displays the percentage of edited fractions in each analyzed well. A point diagram has two axes. The x-axis shows the analyzed wells and samples, and the y-axis represents the edited fraction, shown as a percentage. To view an additional toolbar that enables actions related to the diagram, such as downloading the plot, hold the pointer over the diagram.
Page 162 To add the point diagram to the report, click Add to report. For more information on reports, see section Reports. Concentration diagram tab for genome editing The Concentration diagram tab shows a diagram that displays the distribution of concentration values in the wells together with their confidence intervals A concentration diagram has two axes. The x-axis shows the analyzed wells and samples, and the y-axis represents the concentration values.
Page 163 bars of individual replicates disappear and only one bar is shown at the sample label that represents the mean edited fraction value of the replicates. When there are no replicates within selected wells for edited target the bars don't change. The corresponding well IDs of the replicates are shown on the x axis.
Page 164 2. Select the applicable reference sample from the Reference sample list. 3. Enter the number of copies per genome in the Copies/genome field. The value should be between 1 and 99. 4. Select the applicable target that you want to investigate from the Target of interest list. 5.
Page 165 CI (95%) – This column shows the value of the confidence interval for the target of interest at a  95% confidence level. Replicates are treated different for multiplex and simplex test setup: Multiplex test (configured target of interest and reference targets are part of the same reaction ...
Page 166 Note: If the selected analysis source contains replicates of the reference sample, your results can be calculated only by using mean results for replicates. In this case the “Show mean values for replicates” check box is marked and can’t be changed. In this case there is a warning message above the table and when the user hover on the checkbox, a tooltip appears to inform the user that selected analysis source contains replicates of the reference sample and result is calculated only by using mean results for replicates.
Page 167 To add the heatmap to the report, click Add to report For more information on reports, see section Reports. Point diagram tab for copy number variation The Point diagram tab shows the diagram that displays the number of copies per genome of the configured copy number variation test and the confidence intervals related to every value.
Page 168 In case that targets are in different reaction mixes each combination of target of interest and reference targets in one sample throughout the selected wells is shown in the diagram with a point for the result. To view detailed information, hold the mouse pointer over its corresponding point. A tooltip with detailed information opens.
Page 169 Concentration diagram tab for copy number variation The concentration diagram tab shows the diagram that displays the concentration values of the configured copy number variation test and the confidence intervals related to every value. A concentration diagram has two axes. x-axis represents labels of wells and samples that it belongs to ...
Page 170 To view the mean values for replicates on the diagram, click Show mean values for replicates. When this checkbox is checked, the concentration diagram shows bars that represents mean concentration value for replicates within the well selection. The label below the bar shows well positions that are included in the replicates value of mean concentration.
Page 171 Gene expression The Software Suite analyzes the gene expression of the samples. The analysis results are put into list views, heatmaps, point diagrams, and concentration diagrams Note: Saving gene expression tests is not yet provided. Setting up a gene expression analysis 1.
Page 172 Replicates are treated different for multiplex and simplex test setup: Multiplex test (configured target of interest and reference targets are part of the same reaction  mix): On the right side above the table there is checkbox which allows the user to show mean values for replicates in addition.
Page 173 Note: If the selected analysis source contains replicates of the reference sample, your results can be calculated only by using mean results for replicates. In this case the “Show mean values for replicates” check box is marked and can’t be changed. In this case there is a warning message above the table and when the user hover on the checkbox, a tooltip appears to inform the user that selected analysis source contains replicates of the reference sample and result is calculated only by using mean results for replicates.
Page 174 To add the heatmap to the report, click Add to report. For more information on reports, see Reports. Point diagram for gene expression The Point diagram tab shows a point diagram view that displays the fold change values of configured gene expression test and the confidence intervals related to every value. A point diagram has two axes.
Page 175 In case that targets are in different reaction mixes each combination of target of interest and reference targets in one sample throughout the selected wells is shown in the diagram with a point for the result. To view detailed information, hold the mouse pointer over its corresponding point. A tooltip with detailed information opens.
Page 176 Concentration diagram for gene expression The concentration diagram tab shows the diagram that displays the concentration values of the configured gene expression test and the confidence intervals related to every value. A concentration diagram has two axes. x-axis represents labels of wells and samples that it belongs to ...
Page 177 To view the mean values for replicates on the diagram, click Show mean values for replicates. When this checkbox is checked, the concentration diagram shows bars that represents mean concentration value for replicates within the well selection. The label below the bar shows well positions that are included in the replicates value of mean concentration.
Page 178: Reports
Reports In the QIAcuity Software Suite, you can create reports about your analysis results of a plate. All created reports remain accessible in the Software Suite and can be downloaded or deleted at any time. Creating a new report for a plate from the analysis environment To create a new report from your analysis results, follow these steps: 1.
Page 179 Pre-view window of selected diagrams to be added in the report. 4. Use the icon to delete a diagram from the list of your diagrams to be included in the report. Use the icon in the preview window or icon in the footer to close the preview window.
Page 180 Create Report view for a plate Use this table as a guide in selecting which information to include in the report. Table 17. Report elements Element Description Report name Every Report needs a specific name, without special characters ~ ‘ “ ! @ ^( ) = [ ] { } : ; , < > | \ . Run details Autor, Start and end time, Run steps, Run status, Software and Instrument version...
Page 181 Managing reports of a plate in the report environment The report environment of a plate provides an overview of all created reports for this plate. You can use this environment to manage your created reports. To enter the report environment of a plate, go to the plate tile in the plate overview.
Page 182 Use this table as a guide in managing your created reports for a specific plate. Table 18. Action button in report environment Action Description Downloads the report in PDF format Delete the report Back to Analysis view of this plate Back to plate overview screen QIAcuity User Manual 07/2020...
Page 183: Operating Plates
In the QIAcuity plate-based system, one reaction mix per well is partitioned into a large number of individual partitions prior to the amplification step, resulting in one or very few templates being present in each partition. QIAGEN offers three different plate types according to specific user needs.
Page 184: Qiacuity Nanoplate 8.5K 24-Well
For better handling of the plate, you can place the plate into the Nanoplate tray that can be ordered as accessory, see Appendix B – QIAcuity Accessories or the QIAcuity webpage on www.qiagen.com. To set up a plate, follow these steps:...
Page 185 RT for 10 minutes. Longer incubation doesn’t lead to unspecific restriction and therefore has no impact on the result. Refer to the Application guide on www.qiagen.com for the recommended restriction enzymes.
Page 186 5. Afterwards, the upper protective foil is removed on the bottom left corner. We recommend that one finger holds the rubber foil on the plate corner in place while the upper transparent foil is pulled off. If the upper foil would be pulled off in another way, the plate seal might get loose.
Page 187: Maintenance Procedures
Maintenance Procedures WARNING/ Risk of personal injury and material damage [W1] CAUTION Only perform maintenance that is specifically described in this user manual. The following maintenance procedures must be carried out to ensure reliable operation of the QIAcuity: Regular maintenance ...
Page 188 General cleaning of the QIAcuity: Mild Detergents (e.g., Mikrozid® AF sensitive)  25% ethanol  Disinfection Ethanol-based disinfectants can be used for disinfection of surfaces: e.g., 25 g ethanol and 35 g 1-propanol per 100 g liquid or Mikrozid Liquid (Schülke & Mayr GmbH, cat. no. 109160). Disinfectants based on glyoxal and quaternary ammonium salt can be used for e.g.
Page 189 Ensure that no liquid runs down the touchscreen. Liquid may be drawn through the dust  protection sealing by capillary forces and cause malfunction of the display. To clean the touchscreen, moisten a soft lint-free cloth with water, ethanol, or a mild detergent and carefully wipe the display.
Page 190: Servicing
Do not use bleach to clean or disinfect the QIAcuity. WARNING Toxic fumes [W23] Do not use bleach to disinfect used labware. Servicing Contact QIAGEN Technical Services or your local distributor for more information about flexible Service Support Agreements from QIAGEN. QIAcuity User Manual 07/2020...
Page 191: Regular Maintenance Procedure Of Qiacuity
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. Regular maintenance procedure of QIAcuity Clean the instrument on a regular basis, especially if fluids have been spilled on the instrument.
Page 192 3. Remove the filter from the swing-out filter compartment. 4. Replace with a new filter and push the compartment to the top to close. QIAcuity User Manual 07/2020...
Page 193: Decontaminating The Qiacuity
If damaged plates were used and the inside of the instrument is contaminated, please contact QIAGEN Technical Services. The QIAcuity should also be decontaminated before shipping (e.g., back to QIAGEN). In this case, a decontamination certificate must be completed to confirm that the decontamination procedure has been carried out.
Page 194 1. Tap the Tools icon. 2. Tap Data Management. 3. To set up an automatic data removal at regular time intervals, select Monthly, Weekly, or Daily from the Clear Temporary Data list. 4. To clear the temporary data manually, tap Clear now. Click OK in the confirmation dialog box to delete the data.
Page 195: Regular Maintenance Procedure For Qiacuity Software Suite
Regular maintenance procedure for QIAcuity Software Suite To monitor the space of your disk, click Disk monitor in the main toolbar. This shows an overview about the state of the disk, disk name, and disk path. It also shows the remaining free space and total space of your disk.
Page 196: Troubleshooting
 Serial number of the instrument  This information will help you and your QIAGEN Technical Service Specialist to deal most efficiently with your issue. Note: Information about the latest software and protocol versions can be found at www.qiagen.com/MyQIAcuity. In some cases, updates may be available for addressing specific problems.
Page 197: Creating A Support Package With The Qiacuity Instrument Software
The instrument starts the test. The ongoing actions and their statuses are shown in the Log File Preview pane. The log from the test can be downloaded as part of a support package. For more information about support package, see Creating a support package. Creating a support package with the QIAcuity instrument software You can create a support package in case of an error.
Page 198 3. In the Support package pane, select Upload to Software Suite. 4. To set the timeframe of the support package, tap Set timeframe . The default timeframe is the last two weeks. 5. Tap the applicable option for your preferred timeframe. Tap Today to create a support package for the current day.
Page 199 To create a support package and save it on a USB drive, follow the steps below. 1. On the toolbar, tap Tools 2. Tap Data Management. 3. Connect a USB drive to the instrument. Wait for the device to detect the USB drive. A notification is displayed once the drive is connected.
Page 200: Creating A Support Package With The Qiacuity Software Suite
To set a custom timeframe, tap From and select a start date from the calendar. Then, tap  To and select an end date from the calendar. 7. Tap Apply to save the changes. 8. Tap Create download. A progress bar is shown. To cancel the download, tap the progress bar. Once the download is complete, a notification is displayed, and the USB drive can be removed from the instrument.
Page 201 Note: The standard package includes the log files and a combined image view of all wells. The extended package includes the log files and the raw images of each single well. By clicking on the calendar symbol, you can define the time frame from which the support package shall be generated.
Page 202: Troubleshooting The Instrument And Software
Plate Seal is loaded into the instrument. A run cannot be started if a plate seal is not detected by the instrument. Only use QIAGEN products for closing the plates. Drawer blocking If the drawer is retrieved and blocked, please ensure that the plate is correctly loaded into the drawer and parallel to the base surface of the drawer.
Page 203 Power OFF the QIAcuity, wait for a few minutes, and power it ON again. Save the file(s) to the USB stick again. Check the USB stick on a PC to ensure it is functional. If the error persists, contact QIAGEN Technical Services.
Page 204 Check if the reaction was set up correctly. Check the cycling and imaging conditions. Check the starting quality and quantity of the template. We recommend that you use QIAGEN kits for sample preparation. No clear separation between Check if the correct protocols and reagents have been used.
Page 205 This error occurs when the data received from the instrument does QIAcuity instrument and software not conform to the expected pattern. Further investigations are required by a QIAGEN Field Service Specialist to diagnose the problem with the instrument. Please contact your distributor or QIAGEN Technical Service.
Page 206: Accessing The System Status And Clearing Errors
Accessing the system status and clearing errors Note: Only administrators can access the instrument status. The QIAcuity allows you to see the status of each of its modules. This is especially useful when a hardware error occurs. Details about errors that occurred on the instrument are shown in the System Status section.
Page 207 6. Restart the instrument. The instrument initializes and all modules are returned to their home positions. Note: If the affected module is not working after you cleared the error and restarted the instrument, contact QIAGEN Technical Services. QIAcuity User Manual 07/2020...
Page 208: Glossary
Separation of the single partitions filled with the reaction volume Support Package Information wrapped up in a *.zip file to be sent via an email program to QIAGEN Technical Services to inform QIAGEN what went wrong at the customer's site and how to...
Page 209: Appendix A - Technical Data
Appendix A – Technical Data QIAGEN reserves the right to change specifications at any time. Operating conditions Power 100–240 V AC, 50/60 Hz, Mains supply voltage fluctuations are not to exceed 10% of nominal supply voltages. Maximum power consumption: QIAcuity One, 2plex: 1000VA...
Page 210: Transport Conditions
Transport conditions Air temperature –25ºC to 60ºC (–13ºF to 140ºF) in manufacturer’s package Relative 5% to 85% (non-condensing) humidity Environmental 2K11 & 2M4 (IEC 60721-3-2) class Ambient 700hPa to 1060hPa pressure Storage conditions Air temperature 5ºC to 40ºC (41ºF to 104ºF) in manufacturer’s package Relative humidity 5% to 85% (non-condensing) Environmental...
Page 211 Process temperature: 35°C to 99°C Thermal Accuracy: ±1°C Ramp rate: approx. 3.0°C/s specifications Homogeneity (over plate surface): ±1°C The QIAcuity Eight features two Thermocyclers that are operated in parallel The 2-plex version features the channels Green and Yellow and the 5-plex Optical version all following channels: specifications...
Page 212 Resolution: 1D Linear: 0.102 mm / 4 mils; PDF417: 0.127 mm / 5 mils; Data Matrix: 0.195 mm / 7.5 mils QIAcuity User Manual 07/2020...
Page 213: Declaration Of Conformity
Recycling can be provided by QIAGEN upon request at additional cost. In the European Union, in accordance with the specific WEEE recycling requirements and where a replacement product is being supplied by QIAGEN, free recycling of its WEEE-marked electronic equipment is provided.
Page 214: California Proposition 65
Representations and warranties made by any person, including representatives of QIAGEN, which are inconsistent or in conflict with the conditions in this warranty shall not be binding upon the Company unless produced in writing and approved by an officer of QIAGEN.
Page 215: Appendix B - Qiacuity Accessories
Appendix B – QIAcuity Accessories For more information and an up-to-date list of available protocols, visit www.qiagen.com. Ordering information Product Contents Cat. no. QIAcuity One, 2plex Device One-plate digital PCR instrument for 911001 detecting up to 2 fluorescent dyes, Nanoplate Roller, USB flash memory and QIAcuity Software Suite: includes 1 preventive maintenance visit.
Page 216 * For all systems, Installation and Training is included but are additionally available as separate service offerings. For specific catalog numbers and additional information, visit www.qiagen.com or contact your local sales representative. † Additional instrument and Service bundles are available.
Page 217 250113 For up-to-date licensing information and product-specific disclaimers, see the respective QIAGEN kit handbook or user manual. QIAGEN kit handbooks and user manuals are available at www.qiagen.com or can be requested from QIAGEN Technical Services or your local distributor. QIAcuity User Manual 07/2020...
Page 218: Appendix C - Informations De Sécurité
L’entretien du QIAcuity ne doit être effectué que par un spécialiste de l’entretien sur site QIAGEN. Procéder à la maintenance comme décrit dans la section Procédures de maintenance. QIAGEN facture les réparations dues à une maintenance incorrecte. QIAcuity User Manual 07/2020...
Page 219 [W7] Le QIAcuity est conçu pour être utilisé avec les réactifs et les substances fournis avec les kits QIAGEN ou autrement que de la façon décrite dans le mode d’emploi correspondant. L’utilisation d’autres réactifs et d’autres substances peut provoquer un incendie ou une explosion.
Page 220: Sécurité Électrique
Si un liquide s’est répandu à l’intérieur de l’appareil, l’éteindre, le déconnecter de la prise  secteusr et prendre contact avec les services techniques de QIAGEN. Si l’appareil présente un danger électrique, empêcher le reste du personnel de s’en servir et contacter les services techniques de QIAGEN.
Page 221: Environnement
L’appareil peut présenter un danger électrique dans les cas suivants : L’appareil ou le câble d’alimentation semble être détérioré.  Il a été stocké dans des conditions défavorables pendant une longue période.  Il a subi des chocs sévères durant le transport. ...
Page 222 Échantillons Les échantillons peuvent contenir des agents infectieux. Vous devez connaître le risque pour la santé que ces agents représentent et vous devez utiliser, stocker et mettre au rebut ce genre d’échantillons conformément aux règles de sécurité nécessaires. AVERTISSEMENT Échantillons contenant des agents infectieux [W12] Certains échantillons utilisés avec cet appareil peuvent contenir des agents infectieux.
Page 223: Produits Chimiques
Produits chimiques AVERTISSEMENT Produits chimiques dangereux [W13] Certains produits chimiques utilisés avec cet appareil peuvent être dangereux ou le devenir après l’exécution du cycle du protocole. Toujours porter des lunettes de protection, des gants et une blouse de laboratoire. La personne responsable (par exemple, le directeur de laboratoire) doit prendre les précautions nécessaires afin de garantir que le lieu de travail environnant est sûr et que les opérateurs de l’appareil ne sont pas exposés à...
Page 224: Sécurité Contre Les Rayonnements
Sécurité contre les rayonnements Risque de dommages corporels [W16] AVERTISSEMENT Lumière laser avec niveau de danger 2 : Ne pas regarder fixement le faisceau lumineux lors de l’utilisation du lecteur de code-barres portable. Symboles sur le QIAcuity Symbole Emplacement Description Plaque signalétique à...
Page 225: Appendix D - Sicherheitshinweise
Die Instandhaltung des QIAcuity darf nur durch einen Service-Spezialisten des QIAGEN Außendienstes durchgeführt werden. Führen Sie alle Wartungsarbeiten gemäß den Anweisungen im Abschnitt Wartungsarbeiten dieses Handbuchs durch. QIAGEN stellt Reparaturen, die auf nicht fachgerecht durchgeführte Wartungsmaßnahmen zurückzuführen sind, in Rechnung. QIAcuity User Manual 07/2020...
Page 226 WARNUNG Explosionsgefahr [W7] Der QIAcuity darf ausschließlich mit Reagenzien und Substanzen aus den QIAGEN Kits bzw. gemäß den Angaben in der entsprechenden Gebrauchsanweisung verwendet werden. Die Verwendung anderer Reagenzien und Substanzen kann zu einem Brand oder zu einer Explosion führen.
Page 227: Schutz Vor Stromschlag
VORSICHT Beschädigung des Geräts [C5] Lehnen Sie sich nicht an den Touchscreen, wenn er herausgezogen ist. Schutz vor Stromschlag Hinweis: Ziehen Sie das Netzanschlusskabel aus der Steckdose, bevor Sie Instandhaltungs- /Wartungsarbeiten an einem Gerät vornehmen. WARNUNG Stromschlaggefahr [W8] Jede Unterbrechung des Schutzleiters (Erdungs- bzw. Masseleiter) im Gerät oder außerhalb des Geräts und jede Abtrennung des Schutzleiters am Anschluss der Netzleitung erhöht die Gefahr eines Stromschlags.
Page 228: Umgebung
Falls Flüssigkeit auf dem Gerät verschüttet wird und hineinläuft, schalten Sie es sofort AUS,  ziehen Sie den Netzstecker und setzen Sie sich mit dem Technischen Service von QIAGEN in Verbindung. Falls die elektrische Sicherheit bei der Bedienung des Geräts nicht mehr gewährleistet werden kann, muss das Gerät gegen Benutzung durch darüber nicht informiertes Personal gesichert werden.
Page 229: Biologische Sicherheit
Biologische Sicherheit Bei Substanzen und Reagenzien, die humanes Untersuchungsmaterial enthalten, sollte immer von einer möglichen Infektionsgefahr ausgegangen werden. Wenden Sie nur sichere Laborverfahren an, wie sie z. B. in Veröffentlichungen wie Biosafety in Microbiological and Biomedical Laboratories HHS, (www.cdc.gov/labs/BMBL.html) beschrieben sind. Proben Proben können infektiöse Erreger enthalten.
Page 230: Chemikalien
Chemikalien WARNUNG Gefährliche Chemikalien [W13] Einige Chemikalien, die mit diesem Gerät verwendet werden, können gefährlich sein oder nach Beendigung eines Protokolllaufs gefährlich werden. Tragen Sie immer eine Schutzbrille, Laborhandschuhe und einen Laborkittel. Die verantwortliche Person (z. B. der Laborleiter) muss alle erforderlichen Vorsichtsmaßnahmen treffen, um sicherzustellen, dass die unmittelbare Umgebung des Arbeitsplatzes sicher ist.
Page 231: Strahlensicherheit
Strahlensicherheit Gefahr von Personenschäden [W16] WARNUNG Laserlicht der Gefahrenklasse 2: Schauen Sie bei Verwendung des Barcode- Handscanners nicht in den Laserstrahl. Symbole auf dem QIAcuity Symbol Beschreibung Typenschild an der CE-Markierung der EU-Konformität Geräterückseite Typenschild an der Symbol der CSA-Zertifizierung in Kanada Geräterückseite und den USA Typenschild an der...
Page 232: Document Revision History
Document Revision History Date Changes July 2020 Initial release QIAcuity User Manual 07/2020...
Page 233 QIAGEN specifically disclaims any other licenses, exTaped or implied other than those exTaply stated. The purchaser and user of the kit agree not to take or permit anyone else to take any steps that could lead to or facilitate any acts prohibited above. QIAGEN may enforce the prohibitions of this Limited License Agreement in any Court, and shall recover all its investigative and Court costs, including attorney fees, in any action to enforce this Limited License Agreement or any of its intellectual property rights relating to the kit and/or its components.
Page 234 Ordering www.qiagen.com/shop | Technical Support support.qiagen.com | Website www.qiagen.com QIAcuity User Manual 07/2020...

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