Qiagen QIAcube Connect MDx User Manual
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Qiagen QIAcube Connect MDx User Manual

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QIAcube
MDx User Manual
The QIAcube Connect MDx is intended for in vitro diagnostic use.
9003070
QIAGEN GmbH, QIAGEN Strasse 1, D-40724 Hilden
R1
1121932
Sample to
Insight__
Connect
®
December 2020

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  • Page 1 December 2020 QIAcube Connect ® MDx User Manual The QIAcube Connect MDx is intended for in vitro diagnostic use. 9003070 QIAGEN GmbH, QIAGEN Strasse 1, D-40724 Hilden 1121932 Sample to Insight__...

  • Page 2: Table Of Contents

    About this user manual ................6 1.1.1 Technical assistance ................6 1.1.2 Policy statement ..................7 Intended use of the QIAcube Connect MDx ............ 7 Requirements for QIAcube Connect MDx users ..........7 Glossary ....................8 Accessories ....................8 Safety Information ....................9 Proper use ....................
  • Page 3 Grounding requirements ................40 Unpacking the QIAcube Connect MDx ............40 Installing the QIAcube Connect MDx ............41 4.3.1 Removal of the QIAcube Connect MDx accessories and shipping material ..41 4.3.2 Installation of AC power cord ..............42 4.3.3 Installation of external barcode scanner ..........43 4.3.4...
  • Page 4 Operating the centrifuge after cleaning ..........120 Optional Maintenance ................121 6.7.1 UV run ....................121 6.7.2 Tightness test ..................123 Decontaminating the QIAcube Connect MDx ..........124 Servicing ....................124 Troubleshooting ....................125 Contacting QIAGEN Technical Services ............125 Creating a support package ..............125 Operation ....................126 QIAcube Connect MDx User Manual 12/2020...
  • Page 5 Mechanical data and hardware features ...........143 Declaration of Conformity ................144 Waste Electrical and Electronic Equipment (WEEE) ........144 EMC Declaration ..................145 Liability Clause ..................146 Appendix B – QIAcube Connect MDx Accessories .............148 Version history .....................151 Index 152 QIAcube Connect MDx User Manual 12/2020...

  • Page 6: Introduction

    Thank you for choosing the QIAcube Connect MDx. We are confident it will become an integral part of your laboratory. Before using the QIAcube Connect MDx, 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.

  • Page 7: Policy Statement

    QIAcube Connect MDx system. The QIAcube Connect MDx is intended to be used only in combination with QIAGEN and PAXgene kits indicated for use with the QIAcube Connect MDx for the applications that will be described in the kit handbooks.

  • Page 8: Glossary

    1.4 Glossary For a glossary of terms used in this User Manual, refer to Section 8. 1.5 Accessories For information about QIAcube Connect MDx accessories, refer to Appendix B of this User Manual. QIAcube Connect MDx User Manual 12/2020...

  • Page 9: Safety Information

    2 Safety Information Before using the QIAcube Connect MDx, 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.
  • Page 10 Avoid spilling water or chemicals onto the QIAcube Connect MDx. Damage caused by water or chemical spillage will void your warranty. In case of emergency, power OFF the QIAcube Connect MDx at the power switch located in front of the instrument and unplug the power cord from the power outlet.

  • Page 11: Electrical Safety

    QIAGEN kits or other than outlined in respective Information for use. Use of other reagents and substances may lead to fire or explosion. If hazardous material is spilled on or inside the QIAcube Connect MDx, the user is responsible for carrying out appropriate decontamination.

  • Page 12: Environment

    Only perform maintenance that is specifically described in this user manual. To ensure satisfactory and safe operation of the QIAcube Connect MDx, follow these guidelines: The line power cord must be connected to a line power outlet that has a protective conductor ...

  • Page 13: Biological Safety

    Operating conditions WARNING Explosive atmosphere [W11] The QIAcube Connect MDx 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 QIAcube Connect MDx must be located out of direct sunlight.

  • Page 14: Chemicals

    WARNING Toxic fumes [W14] Do not use bleach to clean or disinfect the QIAcube Connect MDx. Bleach in contact with salts from the buffers can produce toxic fumes. OSHA : Occupational Safety and Health Administration (United States of America). ACGIH : American Conference of Government Industrial Hygienists (United States of America).

  • Page 15: Waste Disposal

    These hazardous wastes must be collected and disposed of properly according to local safety regulations. For more information about how to dispose of the QIAcube Connect MDx, see section 9.6, Waste Electrical and Electronic Equipment (WEEE). WARNING...

  • Page 16: Centrifuge

    Make sure that the rotor and buckets are installed correctly. All buckets must be mounted before starting a protocol run, regardless of the number of samples to be processed. If the rotor or buckets show signs of mechanical damage or corrosion, do not use the QIAcube Connect MDx; contact QIAGEN Technical Services.

  • Page 17: Heat Hazard

    Damage to the instrument [C8] After a power failure, do not move the z-module (robotic arm) manually in front of the instrument. Damage may occur if the QIAcube Connect MDx hood is closed and collides with the z-module. WARNING Risk of personal injury and material damage [W20] Raise the centrifuge lid carefully.
  • Page 18 Risk of explosion [W23] WARNING When cleaning the QIAcube Connect MDx with alcohol-based disinfectant, leave the QIAcube Connect MDx hood open to allow flammable vapors to disperse. Only clean the QIAcube Connect MDx when worktable components have cooled down. Risk of fire...

  • Page 19: Radiation Safety

    Damage to the instrument [C11] Do not use spray bottles containing alcohol or disinfectant to clean surfaces of the QIAcube Connect MDx. Spray bottles should be used only to clean items that have been removed from the worktables. 2.10 Radiation safety...

  • Page 20: Symbols On The Qiacube Connect Mdx

    2.11 Symbols on the QIAcube Connect MDx Symbol Location Description Next to the Shaker Heat hazard – the temperature of the shaker can reach up to 70ºC (158ºF). Near the centrifuge; near the robotic arm Mechanical hazard — avoid contact with moving parts.

  • Page 21: General Description

    UV LED and robotic gripper. The QIAcube Connect MDx gives the option to start a protocol either in the IVD mode of the software (for validated IVD applications only) or in the Research mode of the software (for Molecular Biology Applications (MBA) only).

  • Page 22: Qiacube Connect Mdx Principle

    2. Each lysate is transferred to a spin column in a rotor adapter. If the lysate needs to be homogenized or cleared, it is first transferred to the middle position of the rotor adapter. 3. Nucleic acids or proteins bind to the silica membrane or purification resin of the QIAGEN spin column and are washed to remove contaminants.
  • Page 23 QIAamp DNA DSP procedure flowchart QIAcube Connect MDx User Manual 12/2020...

  • Page 24: External Features Of The Qiacube Connect Mdx

    3.2 External features of the QIAcube Connect MDx Front view of the QIAcube Connect MDx Pulled-out touchscreen Rear view of QIAcube Connect MDx Rear view of QIAcube Connect MDx Touchscreen 2 USB ports on the left side of the touchscreen; 2 USB ports...
  • Page 25 If the hood sensor or lock is not functioning correctly, contact QIAGEN Technical Services. Power switch The power switch is located at the front right of the QIAcube Connect MDx and is used to power ON and OFF the instrument. RJ-45 Ethernet port The RJ-45 Ethernet port located at the back of the instrument beside the power cord socket, is only used to connect the QIAcube Connect MDx to local area network via cable.
  • Page 26 USB ports The QIAcube Connect MDx has four USB ports. Two are located on the left of the touchscreen and two are located behind the touchscreen. The USB ports located on the left of the touchscreen allow connection of the QIAcube Connect MDx to a USB flash drive.
  • Page 27 Power cord socket The power cord socket is located at the rear right of the QIAcube Connect MDx and allows connection of the QIAcube Connect MDx to a power outlet via the supplied power cord.
  • Page 28 Only perform maintenance that is specifically described in this user manual. Cooling air outlet Cooling air outlets are located at the rear left side of the QIAcube Connect MDx and allow cooling of the internal components of the QIAcube Connect MDx.

  • Page 29: Internal Features Of The Qiacube Connect Mdx

    External barcode scanner The QIAcube Connect MDx is equipped with a 2D handheld barcode scanner to allow kit bar code and sample bar code scanning. WARNING Risk of personal injury [W30] Hazard Level 2 laser light: Do not stare into the light beam when using handheld bar code scanner.
  • Page 30 This ensures that microcentrifuge tubes cannot be displaced during sample processing and allows shaker loading to be checked. The shaker can also be operated individually via the touchscreen (see section 5.1, QIAcube Connect MDx software). QIAcube Connect MDx User Manual 12/2020...
  • Page 31 The reagent bottle rack holds up to six 30 ml QIAcube Connect MDx specific reagent bottles and, for ease of use and high process safety, fits onto the QIAcube Connect MDx worktable only in the correct orientation. Liquid is aspirated from the bottles by the pipetting system. A labeling strip should be attached to the reagent bottle rack.
  • Page 32 Risk of explosion [W7] The QIAcube Connect MDx 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.
  • Page 33 K or another enzyme is required for the purification protocol. Tip rack slots Three tip racks can be placed on the QIAcube Connect MDx worktable. Tips can be purchased in prefilled tip racks holding 200 µl filter-tips or 1000 µl filter-tips, regular or wide-bore.
  • Page 34 Robotic gripper automates spin-column processing Pipetting system The QIAcube Connect MDx is equipped with a single-channel pipetting system that moves in the X, Y and Z directions. The dilutor, fitted with a tip adapter, is connected to a precision syringe pump, which enables accurate transfer of liquids.
  • Page 35 Aborted run  Interior LED The QIAcube Connect MDx is equipped with an interior LED which illuminates the worktable for ease of use. The LED can also indicate the instrument status (e.g. error) by blinking. QIAcube Connect MDx User Manual 12/2020...

  • Page 36: Disposables

    UV LED The QIAcube Connect MDx is equipped with a UV LED light for decontamination. During the maintenance decontamination procedure, the UV LED is moved over the worktable. The hood and the waste drawer must be closed before starting the procedure and must not be opened during the procedure.
  • Page 37 Risk of personal injury and material damage [W5] To prevent plastic crash, load the tubes properly. After a plastic crash, sharp plastic particles could be inside the centrifuge. Be careful when handling items inside the centrifuge. QIAcube Connect MDx User Manual 12/2020...

  • Page 38: Installation Procedures

    (earthed) AC power outlet. The power line to the instrument should be voltage regulated and surge protected. Ensure that the QIAcube Connect MDx is positioned so that it is easy to access the power connector at the back of the instrument and the power switch on the front at all times, and that it is easy to power the instrument OFF and disconnect it.

  • Page 39: Power Requirements

    4.1.2 Power requirements The QIAcube Connect MDx operates at: 100–240 V AC, 50/60 Hz, 650 VA. It can be connected to an uninterruptible power supply (UPS). Ensure that the voltage rating of the QIAcube Connect MDx is compatible with the AC voltage available at the installation site.

  • Page 40: Grounding Requirements

    1. Before unpacking the QIAcube Connect MDx, 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.

  • Page 41: Installing The Qiacube Connect Mdx

    6. Read the packing list to check that you have received all items. If anything is missing, contact QIAGEN Technical Services. 7. Check that the QIAcube Connect MDx is not damaged and that there are no loose parts. If anything is damaged, contact QIAGEN Technical Services. Make sure that the QIAcube Connect MDx has equilibrated to ambient temperature before operating it.

  • Page 42: Installation Of Ac Power Cord

    2. Ensure that the power switch is set to OFF: outer position is OFF and inner position is ON. 3. Check that the voltage rating on the label at the back of the QIAcube Connect MDx matches the voltage available at the installation site.

  • Page 43: Installation Of External Barcode Scanner

    3. Install the rotor nut on top of the rotor and tighten securely using the rotor key supplied with the QIAcube Connect MDx. Make sure that the rotor is securely seated. If the rotor nut is not tightened properly, it can become loose during operation of the centrifuge and can cause serious damage to the instrument.

  • Page 44: Installing The Shaker Adapter

    CAUTION Damage to the instrument [C7] The QIAcube Connect MDx must not be used if the centrifuge lid is broken, or if the lid lock is damaged. Make sure that no loose material is inside the centrifuge during operation. Make sure that the rotor is installed correctly and that all buckets are properly mounted, regardless of the number of samples to be processed.

  • Page 45: Configuration Of The Qiacube Connect Mdx

    4.4 Configuration of the QIAcube Connect MDx When using the QIAcube Connect MDx for the first time, it is recommended to define the required settings. Other settings can be made later when needed. For details on using the touchscreen and software, refer to section 5.1, QIAcube Connect MDx software.

  • Page 46: System Configurations

    For details on software modes, please refer to section 5.1, QIAcube Connect MDx software. After the first login, the system will ask you to change the password for User Admin. 7. Press Log in. The Setup screen appears. Setup screen 8.
  • Page 47 2. Press the System tab. This tab is only available for users assigned the Administrator role. System configuration screen 3. Optionally, enter a name for the QIAcube Connect MDx. The device name serves as the network/host name when connecting the instrument to the network.

  • Page 48: Settings Configuration

    The upload of a new language package is a two-step process. First, the translated Graphical User Interface is uploaded via the Load button. Next, the translated protocols need to be uploaded by following the instructions in section 5.11.1 (Installing new protocols). For more details, contact QIAGEN Technical Services. 4.4.2 Settings configuration...

  • Page 49: Network Configuration

    QIAsphere Base, the outbound TCP port 443 (https) is used; ping is supported. Configuring a wired network connection 1. Connect the QIAcube Connect MDx to a local area network (LAN) by using an Ethernet cable and the RJ45 Ethernet Port on the rear side of the QIAcube Connect MDx.
  • Page 50 Entering the DNS server is optional. These settings will not be validated by the QIAcube Connect MDx. Device network settings screen with manual network configuration entries 6. Press Apply to confirm and save the settings made. QIAcube Connect MDx User Manual 12/2020...
  • Page 51 USB ports behind the touchscreen. Important: Always turn off the QIAcube Connect MDx before you plug in or unplug the Wi-Fi USB device. Plug-and-play of the Wi-Fi USB device while the instrument is turned on is not supported.
  • Page 52 Available networks screen with established wireless network connection Note: If a network is previously configured and a connection is established successfully at least once, the instrument will connect to that network automatically. 6. To disconnect from Wi-Fi press Disconnect. QIAcube Connect MDx User Manual 12/2020...

  • Page 53: Packaging And Transporting Of The Qiacube Connect Mdx

    10. In the Run Modules menu, press the Centrifuge tab and then press Close Centrifuge Lid. 11. When the centrifuge lid is closed, power OFF the QIAcube Connect MDx and open the hood. 12. Insert the foam protector into the front of the instrument.
  • Page 54  17. Place the handheld scanner into dedicated handheld scanner box. 18. Place the QIAcube Connect MDx onto the pallet and put the black foam lid over the top of the instrument. Place the box onto the instrument. Important: When lifting the QIAcube Connect MDx, slide your fingers under both sides of the instrument and keep your back straight.

  • Page 55: Operating Procedures

    This section describes how to operate the QIAcube Connect MDx. Before proceeding, we recommend that you familiarize yourself with the features of the instrument by referring to section 3.2, External features of the QIAcube Connect MDx, and section 3.3, Internal features of the QIAcube Connect MDx.
  • Page 56 Risk of explosion [W7] The QIAcube Connect MDx 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.
  • Page 57 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). ‡ QIAcube Connect MDx User Manual 12/2020...

  • Page 58: Qiacube Connect Mdx Software

    Only perform maintenance that is specifically described in this user manual. 5.1 QIAcube Connect MDx software The QIAcube Connect MDx gives the option to start a protocol either in the IVD mode of the software (validated IVD applications only) or in the Research mode of the software (Molecular Biology Applications (MBA) and customized protocols only).
  • Page 59 Press to show important information that must be followed during run setup for respective item. Navigation back to the Setup screen Tools/Maintenance functions Configuration Log out from the instrument Touchscreen buttons and icons overview for general use QIAcube Connect MDx User Manual 12/2020...
  • Page 60 It is not possible to proceed to the next screen in this case. Press the field again and correct the value according to the range displayed next to the field. QIAcube Connect MDx User Manual 12/2020...

  • Page 61: Switching The Qiacube Connect Mdx On And Off

    1. Switch off the instrument by pressing the power switch to the inner position. Note: After powering OFF the QIAcube Connect MDx, you must wait for a few seconds before you power ON the instrument again. The system might fail to start if you do not allow the QIAcube Connect to rest for a few seconds before powering ON.

  • Page 62: Logging In And Logging Out

    4. Select software mode (IVD or Research). Note: The selected software mode is shown at the bottom of the screen as long as you are logged in. 5. Press Log in. 6. The Setup screen appears. QIAcube Connect MDx User Manual 12/2020...

  • Page 63: Setting Up A Protocol Run

    Commonly used QIAGEN standard protocols (Life Science and DSP protocols) are installed on the QIAcube Connect MDx upon delivery. Available QIAGEN IVD-protocols can be downloaded from the Product Resources tab of the QIAcube Connect MDx product page: https://www.qiagen.com/products/qiacube-connect-mdx. QIAcube Connect MDx User Manual 12/2020...
  • Page 64 2. To start the run setup in the IVD mode, scan the 2-D bar code of the QIAGEN kit. Press Scan Kit and then use the handheld scanner. It is also possible to just scan the bar code without pressing Scan kit.
  • Page 65 Material number (REF), either contains a catalog number or a material number, see label. Kit barcode structure The sample barcode label below means that for this label, the barcode string would be 010405322800290117181231101151234567]24061704: Example of kit barcode label QIAcube Connect MDx User Manual 12/2020...
  • Page 66 Important: Do not use the Next button while the robotic arm is still moving. Many screens have Up ( ) and Down ( ) arrow icons to scroll. Make sure to scroll all texts down to the end and follow the instructions completely. QIAcube Connect MDx User Manual 12/2020...

  • Page 67: Material Selection

    Material selection Select material screen 1. Select the sample material by touching the corresponding row. Only one sample material type can be selected per run. 2. Press Next to proceed to defining the protocol. QIAcube Connect MDx User Manual 12/2020...

  • Page 68: Protocol Selection

    Important: Ensure to read all essential and critical information in the right pane (scroll down if necessary) before proceeding to the next step. 2. Press Next to proceed to defining the run parameters. QIAcube Connect MDx User Manual 12/2020...

  • Page 69: Parameter Definition

    Refer to section 5.11.1, Installing new protocols, for details about the on-screen keyboard. 2. Press Next to proceed to defining the sample number. The software automatically proceeds to the next screen. Follow the instructions in the corresponding section below. QIAcube Connect MDx User Manual 12/2020...

  • Page 70: Sample Number Definition

    1. To select the number of samples for the run, press the corresponding number on the screen. Sample numbers (1 and 11) that would lead to a misbalance during centrifugation cannot be chosen. 2. Press Next to proceed to loading the reagents. 5.4.5 Loading buffer bottles Load buffer bottles screen QIAcube Connect MDx User Manual 12/2020...
  • Page 71 Load buffer bottle screen circles the position on the buffer bottle rack for selected buffer in the list. Before proceeding to the next step, ensure that you read all essential and critical information indicated in the Information icon ( ) marked in red. Press the icon to open the information. QIAcube Connect MDx User Manual 12/2020...
  • Page 72 We recommend to reuse the buffer bottles only until one kit is used up. As soon as a new QIAGEN kit is opened, new buffer bottles should be used. 3. Place each opened buffer bottle in the correct position of the reagent bottle rack as shown on the screen.

  • Page 73: Loading Tips And Enzymes

    Risk of fire or explosion [W6] WARNING When using ethanol or ethanol-based liquids on the QIAcube Connect MDx, handle such liquids carefully and in accordance with the required safety regulations. If liquid has been spilled, wipe it off and leave the QIAcube Connect MDx hood open to allow flammable vapors to disperse.
  • Page 74 There are 3 different kinds of tip racks that can be used on the QIAcube Connect MDx, depending on the protocol selected. A blue rack for 200 µl filter-tips, a light grey rack for 1000 µl filter-tips and a dark grey rack for 1000 µl wide-bore filter-tips.

  • Page 75: Loading The Centrifuge

    Spin columns with partially removed lids may not be gripped properly by the robotic gripper, and may cause the protocol run to crash. QIAcube Connect MDx User Manual 12/2020...
  • Page 76 Depletion Spin Columns), remove the screw cap from the spin column, and screw on a spin column adapter ring (not supplied with the QIAcube Connect MDx; see section 10, Appendix B - QIAcube Connect MDx Accessories) onto the column. The spin column adapter ring enables the robotic gripper to transfer the column during the purification procedure.
  • Page 77 Rotor adapter is incorrectly loaded with a 1.5 ml microcentrifuge tube. The lid of the tube is positioned in the wrong slot of the rotor adapter. During column transfer, the lid of the spin column could crash onto the lid of the 1.5 ml microcentrifuge tube, causing the protocol run to crash. QIAcube Connect MDx User Manual 12/2020...
  • Page 78 This section describes a workflow that includes the shaker unit (e.g., for lysis). Tubes with samples need to be loaded onto the shaker unit (refer to section 5.4.8, Loading the shaker), and the centrifuge must be prepared according the following description. QIAcube Connect MDx User Manual 12/2020...
  • Page 79 5. If required and described in the table, cut off the lid, or screw on a spin-column adapter ring and break off the bottom of the spin column. 6. Repeat steps 1–5 until all rotor adapters have been prepared. QIAcube Connect MDx User Manual 12/2020...
  • Page 80 The table shows how to load each rotor adapter. The Pos. column indicates the position in the rotor adapter, and the Lid position column indicates where to place the lid of a particular tube. QIAcube Connect MDx User Manual 12/2020...
  • Page 81 The sample ID is initially created using the YYYYMMDD-HHMM-no. format. Be sure that the same ID can be found on the respective elution tube on a sticky label, which is safely attached. View sample details screen QIAcube Connect MDx User Manual 12/2020...

  • Page 82: Loading The Shaker

    2. If required, change the default Sample IDs in the respective fields using the on-screen keyboard. You can enter the value manually or scan the sample bar code using a barcode scanner. The sample ID is initially created using the YYYYMMDD-HHMM-no. format. QIAcube Connect MDx User Manual 12/2020...
  • Page 83 Information icon ( ). Make sure that the lid/shaker rack plug is securely seated in the slot. Do not place a lid or shaker rack plug next to an empty shaker rack position. QIAcube Connect MDx User Manual 12/2020...
  • Page 84 Important: Do not use 1.5 ml microcentrifuge tubes on the shaker. These microcentrifuge tubes can cause filter-tips to stick during sample transfer. Using this tube on the shaker can damage the pipetting system and can cause a centrifuge crash. QIAcube Connect MDx User Manual 12/2020...

  • Page 85: Starting A Protocol Run

    If the tip adapter has picked up a tip, it must be removed manually. Note: For the very first run, the estimated run duration is not available. Run status screen during a protocol run QIAcube Connect MDx User Manual 12/2020...
  • Page 86 4. Press Done to create the report file. The run report is a PDF file and contains the following information: the protocol information (name and the version of the completed application process file)  the serial number of the instrument  QIAcube Connect MDx User Manual 12/2020...

  • Page 87: Stopping A Protocol Run

    In case of emergency, a run can be stopped by pressing the Stop Run button on the run status screen (see section 5.5, Starting a protocol run). To confirm the run stopped, click Yes in the Stop Run dialog. Stop run screen QIAcube Connect MDx User Manual 12/2020...

  • Page 88: Saving Run Reports To The Usb Flash Drive

    Warning on critical remaining disk space On a regular basis, you can also check the free disk space by clicking on the Configuration icon located on the right side of the System tab screen. Free disk space information QIAcube Connect MDx User Manual 12/2020...
  • Page 89 USB flash drive will appear. The USB flash drive can be removed from the instrument. Important: Do not remove the USB flash drive while the files are downloading. Wait until the download is completed QIAcube Connect MDx User Manual 12/2020...

  • Page 90: Low Space On Flash Memory

    Full disk space system alert 5.9 Independent heater/shaker operation The heater/shaker can be operated individually if the QIAcube Connect MDx is not running a protocol. The heating and shaking functions are not interlinked and can be used independently or in combination.
  • Page 91 6. Close the hood to start run. The remaining time and current temperature and status of the heater are displayed on the screen. Wait until the operation is completed. To stop the run progress, press Stop. Heater Shaker operation screen QIAcube Connect MDx User Manual 12/2020...

  • Page 92: Independent Centrifuge Operation

    5.10 Independent centrifuge operation The centrifuge can be operated individually if the QIAcube Connect MDx is not running a protocol. Do not attempt to move the QIAcube Connect MDx during operation. CAUTION Damage to the instrument [C7] The QIAcube Connect MDx must not be used if the centrifuge lid is broken, or if the lid lock is damaged.
  • Page 93 5. If the centrifuge lid is not open, press Open Centrifuge Lid. 6. If required, load opened 1.5 ml microcentrifuge elution tubes and/or QIAGEN spin columns into the rotor adapters and place the lids into the appropriate slots in the rotor adapter.
  • Page 94 It is only required in case you need to prepare the QIAcube Connect MDx for shipment. Loading scheme: No. of samples Centrifuge loading scheme No. of samples Centrifuge loading scheme Load all positions Centrifuge loading scheme QIAcube Connect MDx User Manual 12/2020...

  • Page 95: Managing Protocols

    Note: Do not rename or modify the protocol files. Otherwise, they cannot be used. 2. Connect the USB flash drive to the QIAcube Connect MDx using one of the USB ports at the left of the touchscreen.

  • Page 96: Deleting All Protocols

    7. Wait until the transfer is complete. A message is displayed when the transfer is complete. 8. Remove the USB flash drive and power OFF the QIAcube Connect MDx. 9. Wait a few seconds and then power ON the QIAcube Connect MDx. To use the new protocols, log in again.

  • Page 97: Saving Protocols

    Protocols can be downloaded from the instrument to USB flash drive to transfer them to another instrument or to save them before a software update. Use the USB flash drive provided by QIAGEN. 1. Connect the USB flash drive that was shipped together with the instrument to the QIAcube Connect MDx using one of the USB ports at the left of the touchscreen.

  • Page 98: Updating Software

    System configuration screen 4. On a computer running Microsoft Windows, download and transfer the software ZIP file to the main folder of the USB flash drive provided with the QIAcube Connect MDx and extract the ZIP file there. Note: After extraction, make sure that all files from the ZIP file are extracted to the main folder of the USB flash drive.
  • Page 99 6. Press Update Software to start the software update. Follow the instructions on the screen. System configuration screen 7. The software update tool is displayed. Press Start update to start the software update. Software update tool screen QIAcube Connect MDx User Manual 12/2020...

  • Page 100: User Management

    When you use the QIAcube Connect MDx for the first time, a default user named Admin is already pre-installed and configured with both roles assigned. The user management feature is only available for users assigned the Administrator role.

  • Page 101: Setting Up A New User

    Note: With the administrator role, it is required to create at least one other user. 3. Press New to add a new user. 4. Enter the respective data for the new user. Keep the Activate User box checked. Add User screen QIAcube Connect MDx User Manual 12/2020...
  • Page 102 Selection of user role in Add User screen The E-mail address field is optional. The system does not confirm whether the e-mail address entered is valid. 5. Press OK to save the new user. QIAcube Connect MDx User Manual 12/2020...

  • Page 103: Changing Data For An Existing User

    List of configured users in the user management 3. In the user profile row, press the Edit ( ) icon. 4. A screen will appear showing the current information of the user. Edit the information as necessary. Edit User screen QIAcube Connect MDx User Manual 12/2020...

  • Page 104: Deleting Or Temporarily Deactivating A User

    ) in the user profile row. Check the Activate user box. Note: If a user tries to login with the wrong password, the user profile will be automatically deactivated after the set number of failed login attempts. QIAcube Connect MDx User Manual 12/2020...

  • Page 105: Changing Password

    User with Operator role can change its own password. Follow the instructions below: 1. Press the Configuration icon ( ) on the menu bar. 2. For users with the role Operator, the Password tab is automatically active QIAcube Connect MDx User Manual 12/2020...
  • Page 106 Note: The new password must be different from the last three used passwords. 5. Press OK to save the new password. Press Cancel to discard any changes and to keep the old password. 6. To return to the setup screen, press the Setup icon ( QIAcube Connect MDx User Manual 12/2020...

  • Page 107: Cleaning And Maintenance

    The software provides step-by-step guidance under Tools/Maintenance for the maintenance procedures listed above, except for the regular maintenance. Following these procedures ensures that the QIAcube Connect MDx is free from dust and liquid spills. Select the cleaning agent according to the objective of the cleaning procedure, the sample material used and the downstream assay.

  • Page 108: Cleaning Agents

    Connect MDx workstation. Spray bottles should be used only for items that have been removed from the workstation. If solvents or saline, acidic, or alkaline solutions are spilt on the QIAcube Connect MDx or if  QIAGEN buffers splash the instrument hood, wipe the spilt liquid away immediately.
  • Page 109 Damage to the instrument [C11] Do not use spray bottles containing alcohol or disinfectant to clean surfaces of the QIAcube Connect MDx. Spray bottles should be used only to clean items that have been removed from the worktables. Risk of fire...
  • Page 110 Connect MDx hood open to allow flammable vapors to disperse. WARNING Toxic fumes [W14] Do not use bleach to clean or disinfect the QIAcube Connect MDx. Bleach in contact with salts from the buffers can produce toxic fumes. WARNING Toxic fumes [W15] Do not use bleach to disinfect used labware.

  • Page 111: Regular Maintenance

    3. Replace the lids of the reagent bottles and close tightly. Store the bottles according to the instructions in the relevant kit handbook. You can now run another protocol or switch off the QIAcube Connect MDx. 6.4 Daily maintenance After running the last protocol of the day, perform the daily maintenance procedure. The software...
  • Page 112 We recommend to reuse the buffer bottles only until the kit is used up. As soon as a new QIAGEN kit is opened, new buffer bottles should be used. 6. Press Done to confirm that the steps have been completed.

  • Page 113: Monthly Maintenance

    Depending on the disinfectant, wipe the screen with distilled water. Wipe dry with a paper towel. 6. Clean the outer hood with a soft lint-free cloth moistened with water or mild detergent. QIAcube Connect MDx User Manual 12/2020...

  • Page 114: Periodic Maintenance

    8. Press Done only when the steps listed above have been successfully completed. The date of the last performed monthly maintenance is updated automatically. Important: Inspect the waste drawer during maintenance. Contact QIAGEN Technical Services if any broken parts are observed.

  • Page 115: Cleaning The Centrifuge

    Cleaning of the centrifuge arm must be performed periodically or could be performed if required. For example, the centrifuge must be cleaned in case of plastic crash or spillage of liquids due to crash. QIAcube Connect MDx User Manual 12/2020...
  • Page 116 5. When cleaning is completed, turn on the instrument and log in. Press the Tools icon and then the Maintenance tab. Select the Centrifuge subtab. 6. Press Start again then press Done to confirm cleaning. The date of the last performed cleaning of centrifuge is updated automatically. QIAcube Connect MDx User Manual 12/2020...
  • Page 117 Cleaning the rotor and buckets Note: Ensure that the instrument is switched off during cleaning. 1. Make sure the QIAcube Connect MDx is switched off. 2. Remove all disposable rotor adapters, including tubes and spin columns, from the buckets. 3. Remove the buckets from the rotor. Undo the rotor nut on top of the rotor using the rotor key, and carefully lift the rotor off the rotor shaft.
  • Page 118 After cleaning the rotor thread, apply a few drops of mineral oil (Anti-Corrosion Oil (rotor), cat. no. 9018543) on a lint-free cloth, and wipe the thread. A thin, invisible oil film should cover the rotor thread but no droplets or smear should appear. QIAcube Connect MDx User Manual 12/2020...
  • Page 119 3. Install the rotor nut on top of the rotor and tighten securely using the rotor key supplied with the QIAcube Connect MDx. Make sure that the rotor is securely seated. Rotor key.

  • Page 120: Operating The Centrifuge After Cleaning

    The centrifuge tab is open by default. Run Modules screen 3. In the Set speed and Set duration fields, set the speed to 10,000 g and the duration to 1 min (1:0 m:s), respectively. QIAcube Connect MDx User Manual 12/2020...

  • Page 121: Optional Maintenance

    The UV run is recommended to be performed daily for decontamination purposes. It helps to reduce possible pathogen or nucleic acid contamination of the QIAcube Connect MDx worktables. The efficiency of inactivation is to be determined for each specific organism and depends, for example, on layer thickness and sample type.
  • Page 122 5. Press Done once the UV run is completed. The date of the last performed UV-run is updated automatically. WARNING Risk of personal injury [W29] Do not expose your skin to UV-C light from the UV LED lamp. QIAcube Connect MDx User Manual 12/2020...

  • Page 123: Tightness Test

    After the load check, the robotic arm will pick up a tip, aspirate ethanol and move to the tube. The tip will remain in place above the tube for 2 minutes. The tip will be discarded into the waste afterwards. QIAcube Connect MDx User Manual 12/2020...

  • Page 124: Decontaminating The Qiacube Connect Mdx

    6.8 Decontaminating the QIAcube Connect MDx If the QIAcube Connect MDx is contaminated with infectious material, it should be decontaminated. If hazardous material is spilt on or inside the QIAcube Connect MDx, the user has responsibility for carrying out appropriate decontamination.

  • Page 125: Troubleshooting

    In some cases, updates may be available for addressing specific problems. 7.2 Creating a support package The support package is a zip file that can be sent to QIAGEN Technical Services for diagnosis and trouble shooting. 1. On the menu bar, press the Tools icon ( 2.

  • Page 126: Operation

    Remove the rotor and check the centrifuge chamber for loose plasticware. Power OFF the QIAcube Connect MDx, wait for a few minutes, and power it ON again. If the error persists, contact QIAGEN Technical Services.
  • Page 127 Robotic arm does not return to set Ensure that the instrument is placed on a stable, flat and position level surface as described in section 4.1.1, Site requirements. In other cases, contact QIAGEN Technical Services. Instrument loading In case of incorrect instrument loading, thoroughly read the error message.
  • Page 128 Contact QIAGEN Technical Services for repair. Error when copying files to USB Power OFF the QIAcube Connect MDx, wait for a few minutes, and power it ON again. Save the file(s) to the USB flash drive again. Check the USB flash drive on a PC to ensure it is functional.

  • Page 129: Protocol Interruption

    If an error occurs during a protocol run, it is possible to continue sample preparation manually. Important: It is not recommended for QIAGEN DSP/IVD protocols to finish the run manually, the run will be invalid and the sample result from the manual continuation of the protocol must not be used for diagnostic purposes.
  • Page 130 1. Power OFF the QIAcube Connect MDx. 2. Unplug the power cord from the power outlet. Wait 10 minutes for the rotor to stop. 3. Open the instrument hood. 4. Carefully move the robotic arm to the right side of the worktable, furthest away from the centrifuge lid.

  • Page 131: Reagent Volume Detection And Ultrasonic Pipe

    Contact QIAGEN Technical Services for instructions on how to reset the lid. Liquid spills in the centrifuge The rotor adapter is designed for use with QIAGEN automated protocols. Do not fill the rotor adapters with liquid. Liquid spills may occur if QIAGEN spin columns become blocked due to sample overloading. Do not exceed the maximum amount of starting material.

  • Page 132: Touchscreen

    It is recommended to use a touch pen or an unused tip for optimal calibration results. In case you use a tip, discard the tip after calibration. To re-calibrate the touchscreen: 1. Turn OFF the QIAcube Connect MDx. 2. Wait a few minutes and then turn ON the instrument again. QIAcube Connect MDx User Manual 12/2020...
  • Page 133 3. In the second screen press the QIAGEN logo. Note: If you do not press the logo, the instrument will continue initialization. Press the QIAGEN logo 4. Press Calibrate touchscreen. Calibrate Touch Screen Button 5. An information message is displayed. The message will close automatically after 10 seconds.

  • Page 134: O-Ring Exchange

    Dripping on the worktable  In any case, it is recommended to consult QIAGEN technical service. The replacement procedure requires the O-Ring change tool and an O-Ring. See section 10, Appendix B - QIAcube Connect MDx Accessories, for ordering details.
  • Page 135 O-Ring subtab. The screen shows the last O-Ring replacement date. O-Ring maintenance screen 2. Close the hood and press Start to begin the O-Ring replacement procedure. Follow the instructions on the screen. Details are provided in the next steps below. QIAcube Connect MDx User Manual 12/2020...
  • Page 136 Press the peg down using the back end of the tweezer Open the grey lever and insert the peg with small end first into hole as shown. QIAcube Connect MDx User Manual 12/2020...
  • Page 137 5. Load the O-Ring tool by opening the grey lever into tip rack position 1 (nearest to user). Load the O-ring tool 6. Close the hood and press Next to begin cutting of the O-Ring. 7. To cut and remove the O-Ring, perform the following steps: QIAcube Connect MDx User Manual 12/2020...
  • Page 138 Open the grey lever and remove the O-Ring (by using the tweezers) from pipetting channel. Note: If required, repeat cutting process until O-Ring is cut completely and can be removed. Open the grey lever and remove the O-Ring using the tweezers QIAcube Connect MDx User Manual 12/2020...
  • Page 139 Risk of personal injury and material damage [W1] Improper use of the QIAcube Connect MDx may cause personal injuries or damage to the instrument. The QIAcube Connect MDx must only be operated by qualified personnel who have been appropriately trained.

  • Page 140: Glossary

    Power switch A button located at the front of the QIAcube Connect MDx in the bottom-right corner. It allows the user to switch the QIAcube Connect MDx on and off; inner position is ON and outer position is OFF.
  • Page 141 A metal probe installed on the pipettor head. During operation of the QIAcube Connect MDx, the tip adapter picks up filter-tips from the worktable. Tip disposal slots Slots in the QIAcube Connect MDx worktable through which used filter-tips are discarded into the waste drawer.

  • Page 142: Appendix A - Technical Data

    9 Appendix A – Technical data QIAGEN reserves the right to change specifications at any time. 9.1 Operating conditions Power 100–240 V AC, 50/60 Hz, 650 VA Mains supply voltage fluctuations are not to exceed 10% of nominal supply voltages.

  • Page 143: Mechanical Data And Hardware Features

    Dimensions Width: 65 cm (25.6 in.) (hood open) Height: 86 cm (34 in.) Depth: 62 cm (24.4 in.) Mass QIAcube Connect MDx: 71.5 kg (157.6 lb.) Accessories: 3 kg (6.6 lb.) Centrifuge 10,640 rpm maximum 12,000 maximum Swing-out rotor, maximum 45°...

  • Page 144: Declaration Of Conformity

    Symbol Contrast: 20% minimum reflectance difference Decode Capability: Reads standard 1D, PDF, 2D, Postal and OCR symbologies Software QIAGEN protocols are preinstalled on the QIAcube Connect MDx or can be downloaded at https://www.qiagen.com/products/qiacube-connect-mdx, see the Product Resources tab. 9.5 Declaration of Conformity...

  • Page 145: Emc Declaration

    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 146: Liability Clause

    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 147 QIAGEN assumes no liability for computer viruses, worms, trojans, malware, hacks, or any other type of cybersecurity breaches. QIAcube Connect MDx User Manual 12/2020...

  • Page 148: Appendix B - Qiacube Connect Mdx Accessories

    10 Appendix B – QIAcube Connect MDx Accessories For more information and an up-to-date list of available protocols, visit https://www.qiagen.com/products/qiacube-connect-mdx and go to the Product Resources tab. Ordering Information Product Contents Cat. no. QIAcube Connect MDx Instrument and 1-year warranty on parts and labor...
  • Page 149 For 240 preps: 240 Disposable Rotor Adapters and 240 990394 microcentrifuge tubes (1.5 ml); for use with the QIAcube Connect Rotor Adapter Holder Holder for 12 disposable rotor adapters; for use with the QIAcube 990392 Connect MDx QIAcube Connect MDx User Manual 12/2020...
  • Page 150 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.

  • Page 151: Version History

    11 Version history Document Date Description HB-2794-001 December 2020 Initial Release of QIAcube Connect MDx User Manual QIAcube Connect MDx User Manual 12/2020...

  • Page 152: Index

    Chemicals, 14 Instrument administration, 38 Electrical safety, 11 Instrument configuration, 45 Heat hazard, 17 Instrument operation, 55 Maintenance, 17 Intended use, 7 Mechanical hazards, 15 Internal features of QIAcube Connect, 29 Operating conditions, 13 QIAcube Connect MDx User Manual 12/2020...
  • Page 153 Declaration of Conformity, 144 Warnings, 9 FCC Declaration, 145 Waste drawer, 26 Hardware features, 143 Waste Electrical and Electronic Equipment Liability Clause, 146 (WEEE), 144 Mechanical data, 143 Wi-Fi configuration, 51 Operating conditions, 142 QIAcube Connect MDx User Manual 12/2020...
  • Page 154 (Veltek Associates, Inc.). Registered names, trademarks, etc. used in this document, even when not specifically marked as such, are not to be considered unprotected by law. HB-2794-001 12/2020 1121932 © 2020 QIAGEN, all rights reserved. QIAcube Connect MDx User Manual 12/2020...
  • Page 155 Technical Support www.support.qiagen.com QIAcube Connect MDx User Manual 12/2020 1121932 12/2020 HB-2794-001...

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