Page 1 May 2022 Connect MDx ® User Manual The EZ2 Connect MDx is intended for in vitro diagnostic use. 9003230 QIAGEN GmbH QIAGEN Strasse 1, 40724 Hilden, GERMANY 1124548 Sample to Insight__...
Page 2: Table Of Contents
About this user manual ..................6 General information ..................7 1.2.1 Technical assistance ................7 1.2.2 Policy statement ..................7 Intended use of the EZ2 Connect MDx ..............8 Requirements for EZ2 users ................8 Materials required ..................8 Materials required but not provided ..............9 Glossary ......................9 Accessories ....................9 Safety Information ....................10...
Page 3 Installation of Wi-Fi adapter (optional) ............52 4.3.5 Initial configuration of the EZ2 ...............52 4.3.6 Performing camera exposure calibration ..........54 Packaging and Transportation of the EZ2 Connect MDx ........56 Operating Procedures .....................57 General information ..................60 5.1.1 Entering text and numbers ..............62 Starting the EZ2 ...................65...
Page 4 5.10.1 Loading and unloading the cartridge rack ..........130 5.10.2 Loading and unloading the tip rack ............. 131 5.11 Using the bar code scanner ..............132 5.12 Data menu .................... 133 Run reports ....................134 Support package ................... 137 EZ2 Connect MDx User Manual 05/2022...
Page 5 Waste Electrical and Electronic Equipment (WEEE) ..........168 California Proposition 65 Warning ............... 169 Liability Clause ....................169 Appendix B – EZ2 Connect MDx Accessories ..............170 Ordering Information ................... 170 Document Revision History ....................171 EZ2 Connect MDx User Manual 05/2022...
Page 6: Introduction
Introduction Thank you for choosing the EZ2 Connect MDx. We are confident it will become an integral part of your laboratory. This user manual describes the EZ2 Connect MDx. Before using the EZ2 Connect MDx, it is essential that you read this user manual carefully and pay attention to the safety information.
Page 7: General Information
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 Ez2 Connect Mdx
The EZ2 Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the EZ2 Connect MDx instrument for the applications described in the kit handbooks. The EZ2 Connect MDx system is intended for use by professional operators, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ2 Connect MDx system.
Page 9: Materials Required But Not Provided
For a glossary of terms used in this user manual, refer to the Glossary section (page 163) of this user manual. Accessories For information about EZ2 accessories, refer to the Appendix B – EZ2 Connect MDx Accessories section (page 170) of this user manual. EZ2 Connect MDx User Manual 05/2022...
Page 10: Safety Information
Member State (only applicable for CE-marked devices with an authorized representative established in the EU) and the regulatory authority in which the user and/or the patient is established. EZ2 Connect MDx User Manual 05/2022...
Page 11: Proper Use
Perform the maintenance as described in the Maintenance Procedures section (see page 141). QIAGEN charges for repairs that are required due to incorrect maintenance. In case of emergency, power OFF the EZ2 at the power switch located in front of the instrument and unplug the power cord from the power outlet.
Page 12 Risk of fire or explosion The EZ2 is intended for use with reagents and substances supplied with QIAGEN kits as 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 EZ2, the user is responsible for carrying out appropriate decontamination.
Page 13: Electrical Safety
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 on the type plate of the instrument. EZ2 Connect MDx User Manual 05/2022...
Page 14 If liquid has spilled inside the instrument, switch off the instrument, and if the spill has not been  completely contained in the tray, disconnect it from the power outlet, and contact QIAGEN Technical Services for advice before attempting any troubleshooting.
Page 15: Operating Conditions
Slits and openings that ensure the ventilation of the instrument must not be covered. WARNING Risk of explosion The EZ2 is intended for use with reagents and substances supplied with QIAGEN kits. Use of other reagents and substances may lead to fire or explosion. EZ2 Connect MDx User Manual 05/2022...
Page 16: Biological Safety
Microbiological and Biomedical Laboratories, HHS (https://www.cdc.gov/labs/pdf/CDC- BiosafetymicrobiologicalBiomedicalLaboratories-2009-P.pdf). 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. EZ2 Connect MDx User Manual 05/2022...
Page 17 * 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) EZ2 Connect MDx User Manual 05/2022...
Page 18: Chemicals
Do not use bleach to disinfect used labware. Bleach in contact with salts from the buffers can produce toxic fumes. Note: If you work with volatile solvents, toxic substances, etc., you must provide an efficient laboratory ventilation system to remove vapors that may be produced. EZ2 Connect MDx User Manual 05/2022...
Page 19: Waste Disposal
The hood is locked during operation for safety reasons and a sensor detects the hood position. If the hood sensor or lock is not functioning correctly, contact QIAGEN Technical Services. EZ2 Connect MDx User Manual 05/2022...
Page 20: Heat Hazard
275 to 285 nm. This wavelength corresponds to ultraviolet light Type C, which can be used to support decontamination procedures. A mechanical lock ensures that the hood is closed for operation of the UV LED. If the hood sensor or lock is not functioning correctly, contact QIAGEN Technical Services.
Page 21: 2.10 Maintenance Safety
The EZ2 must only be operated by suitably qualified personnel. Servicing of the EZ2 instrument must only be performed by QIAGEN Field Service Specialists. Operate the EZ2 instrument only as described in the Operating Procedures section (see page 57).
Page 22 Pieces of paper towel remaining on the worktable could lead to a worktable collision. WARNING/ Risk of personal electric shock CAUTION Do not open any panels on the EZ2 instrument. Only perform maintenance as described in this user manual. EZ2 Connect MDx User Manual 05/2022...
Page 23: 2.11 Symbols On The Ez2 Connect Mdx Instrument
2.11 Symbols on the EZ2 Connect MDx instrument The following symbols appear on the EZ2 Connect MDx instrument. Symbol Location Description Heating system — Heat hazard — the temperature of the heating system can reach up to inside instrument 95ºC.
Page 24 Type plate on the back Consult instructions for use. of the instrument Type plate on the back See warnings and precautions. of the instrument Type plate on the back Date of manufacture. of the instrument EZ2 Connect MDx User Manual 05/2022...
Page 25: General Description
(in the IVD mode of the software), processing of non-DSP kits is also supported (in the Research mode of the software). The EZ2 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 26: External Features Of The Ez2 Connect Mdx
24-channel pipettor head and magnet module. If required by the protocol, the temperature of the liquids is controlled by the heating system. The EZ2 Connect MDx incorporates the following features: An internal camera, which is used for load checks and reagent cartridge bar code reading ...
Page 27 Note: Two additional USB ports are located on the rear of the touchscreen (not shown). Figure 2. The back of the EZ2 instrument. RJ-45 Ethernet port Power cord socket — including instrument main fuse Ventilation openings Instrument type plate EZ2 Connect MDx User Manual 05/2022...
Page 28: Touchscreen
Graphical User Interface (GUI) is displayed on the touchscreen, allowing the user to operate the instrument, set up and start runs, perform maintenance procedures, monitor the instrument status, change settings, and download reports. Figure 3. EZ2 touchscreen display with GUI. EZ2 Connect MDx User Manual 05/2022...
Page 29: Hood
To avoid contact with moving parts during the operation of the EZ2, the instrument must be operated with the hood closed. If the hood sensor or lock is not functioning properly, contact QIAGEN Technical Services. Figure 4. The EZ2 with the hood closed.
Page 30: Power Button
USB drive. For more information on uploading protocols, refer to the Installing new protocols section (5.3.6). For more information on software updates, refer to the Updating software section (see page 82). EZ2 Connect MDx User Manual 05/2022...
Page 31 The Wi-Fi adapter, if used, is connected to the EZ2 using any one of the 3 available USB ports, those on the rear of the touchscreen might be most convenient. Important: Use only the USB flash drive provided by QIAGEN. Do not connect other USB flash drive devices to USB ports Important: Do not remove the USB drive or interrupt power while downloading or transferring data or software to or from the instrument.
Page 32: Rj-45 Ethernet Port
The RJ-45 Ethernet port is located on the back of the instrument (highlighted white in image below). The port is used to connect the EZ2 to a local area network. Figure 6. Location of RJ-45 port. EZ2 Connect MDx User Manual 05/2022...
Page 33: Power Cord Socket
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. EZ2 Connect MDx User Manual 05/2022...
Page 34: Ventilation Openings
3 USB ports. The scanner is used for reading the barcode on the kit Q-Card (supplied with sample preparation kits) and sample bar codes. For more information on how to use the bar code scanner, refer to the Using the bar code scanner section (see page 132). EZ2 Connect MDx User Manual 05/2022...
Page 35: Internal Features Of The Ez2
The worktable itself moves in the Y-direction (meaning front to back) so that the pipettor head is above the appropriate position in the cartridge or tip rack during each action that is performed by the instrument. EZ2 Connect MDx User Manual 05/2022...
Page 36 Figure 9. EZ2 pipettor head. EZ2 Connect MDx User Manual 05/2022...
Page 37: Worktable
Moving parts To avoid contact with moving parts during the operation of the EZ2, the instrument must be operated with the hood closed. If the hood sensor or lock is not functioning correctly, contact QIAGEN Technical Services. WARNING Moving parts Avoid contact with moving parts during operation of the EZ2.
Page 38 Each cartridge consists of 10 sealed reagent wells and 2 empty heating positions. One heating position is a well and the other is a slot that can hold a tube. Figure 12. An EZ1/2 cartridge. EZ2 Connect MDx User Manual 05/2022...
Page 39 24 sample tubes.  — Important: Only use QIAGEN recommended tubes (see respective EZ1 DSP or EZ1&2 kit handbooks for more information). Row B may contain a tube with manually filled components, such as carrier RNA or Ethanol ...
Page 40 Usually holds empty elution tubes, this is also the row closest to the front of the  — instrument, holds up to 24 elution tubes. The tubes recommended by QIAGEN are provided with EZ1 DSP or EZ1&2 kits. Important: Only use QIAGEN recommended tubes for elution.
Page 41: Magnet Module
Figure 17. The EZ2 tray. 3.3.3 Magnet module The EZ2 magnet module consists of magnets that are used to capture magnetic particles that are present in the liquid aspirated into the filter-tips. Figure 18. The EZ2 magnet module. EZ2 Connect MDx User Manual 05/2022...
Page 42: Camera
Camera Figure 19. Camera module. The EZ2 Connect MDx has a built-in camera that is used for load checks and reading bar codes from cartridges. Load checks are done before a protocol run starts. The camera checks if labware has been loaded in the correct positions.
Page 43: Internal Light
Moving parts To avoid contact with moving parts during the operation of the EZ2, the instrument must be operated with the hood closed. If the hood sensor or lock is not functioning correctly, contact QIAGEN Technical Services. 3.3.6 Internal light The EZ2 has a built-in LED light.
Page 44: Installation Procedures
Note: It is recommended to plug the instrument directly into its own power outlet and to not share the power outlet with another lab equipment. WARNING Explosive atmosphere The EZ2 instrument is not designed for use in an explosive atmosphere. EZ2 Connect MDx User Manual 05/2022...
Page 45: Power Requirements
Power requirements The EZ2 operates at: 100–240 V AC +/– 10%, 50/60 Hz, 1000 VA Make sure the voltage rating of the EZ2 is compatible with the AC voltage available at the installation site. EZ2 Connect MDx User Manual 05/2022...
Page 46: Grounding Requirements
AC power cord that, when connected to an appropriate AC power outlet, grounds (earths) the instrument. To preserve this protection feature, do not operate the instrument from an AC power outlet that has no ground (earth) connection. EZ2 Connect MDx User Manual 05/2022...
Page 47: Unpacking The Ez2
Quick start guide and safety instructions  Left and right cartridge racks  Left and right sample/tip racks  Power cord set  USB drive  Silicone grease  Hand-held bar code scanner  Connectivity package (supplied separately)  EZ2 Connect MDx User Manual 05/2022...
Page 48 1. Before unpacking the EZ2, 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, contact QIAGEN Technical Services. 2. Open the top of the transportation box and remove the top layer (PE foam).
Page 49: Installing The Ez2 Connect Mdx
16. Retain the package in case you need to transport the EZ2 in the future. Refer to the Packaging and Transportation of the EZ2 Connect MDx section (page 56) for more details. Using the original package minimizes the possibility of damage during transportation of the EZ2.
Page 50: Removal Of The Ez2 Accessories And Shipping Materials
For details, please contact QIAGEN Technical Services. Note: To ensure that your EZ2 Connect MDx has the latest Software and Protocol versions installed, please visit the EZ2 Connect MDx webpage at https://www.qiagen.com/de/products/ez2-connect-mdx/.
Page 51: Installation Of External Barcode Scanner
1. Remove the barcode scanner from the box. 2. Before powering on the instrument, connect the barcode scanner to any one of the 3 USB ports located either on the front of the instrument or on the rear of the touchscreen. EZ2 Connect MDx User Manual 05/2022...
Page 52: Installation Of Wi-Fi Adapter (Optional)
Note: Make sure that the EZ2 has equilibrated to ambient temperature before powering on. 1. To power on the EZ2 Connect MDx instrument, first ensure the hood is closed. After you press the power button, the power button lights up, the startup screen appears on the touchscreen, a sound plays, and the instrument initializes.
Page 53 Firmware version. For further details, see the Setting basic system data section (see page 67). Figure 24. The System configuration tab. 4. You may adjust settings of the EZ2 Connect MDx according to your preferences through the Instrument settings tab under the Configuration menu. For further details see the Changing Instrument settings section (see page 68).
Page 54: Performing Camera Exposure Calibration
To avoid contact with moving parts during the operation of the EZ2, the instrument must be operated with the hood closed. If the hood sensor or lock is not functioning correctly, contact QIAGEN Technical Services. 1. Before first use in the final installation site, the camera exposure calibration must be performed.
Page 55 Figure 26. Camera exposure calibration screen. 4. During the calibration routine, the following message will be displayed. Figure 27. Camera exposure calibration message. Note: For support or technical advice regarding this, please contact QIAGEN Technical Services or see our Technical Support Centre at http://www.qiagen.com/service-and-support/technical- support.
Page 56: Packaging And Transportation Of The Ez2 Connect Mdx
The EZ2 is too heavy to be lifted by one person. To avoid personal injury or damage to the instrument, do not lift the instrument alone. Before transporting the EZ2 Connect MDx, the instrument must first be decontaminated. Refer to Disinfecting the EZ2 and Removing contamination for more details. Then prepare the instrument as follows.
Page 57: Operating Procedures
External features of the EZ2 and Internal features of the EZ2 sections (see pages 26 and 35, respectively). The EZ2 is intended to be used only in combination with QIAGEN kits indicated for use with the EZ2 instrument for the applications described in the kit handbooks.
Page 58 Risk of explosion The EZ2 is intended for use with reagents and substances supplied with QIAGEN kits as outlined in respective Information for use. Use of other reagents and substances may lead to fire or explosion. EZ2 Connect MDx User Manual 05/2022...
Page 59 * 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) ‡ EZ2 Connect MDx User Manual 05/2022...
Page 60: General Information
Guided maintenance procedures  Generate, save and download run reports, support files and audit trails  Change instrument settings to customize your EZ2  Note: The instrument’s touchscreen does not support swiping and multi gestures. EZ2 Connect MDx User Manual 05/2022...
Page 61 LAN and Wi-Fi, and to log out of the application. The toolbar contains the same buttons throughout the whole application, but some buttons are disabled during protocol setup, protocol runs, and maintenance procedures. EZ2 Connect MDx User Manual 05/2022...
Page 62: Entering Text And Numbers
Entering text and numbers An on-screen keyboard is used for entering text in editable fields of the EZ2 instrument software. To access the keyboard, tap the field that you want to edit. The keyboard appears. EZ2 Connect MDx User Manual 05/2022...
Page 63 Caps Lock . Tap Caps Lock again to turn off the uppercase input mode. To see special characters, tap Special Characters . To go back to the alphabetic characters, tap ABC EZ2 Connect MDx User Manual 05/2022...
Page 64 Some fields have requirements or restrictions that have to be followed. If the entered text does not match the requirements of the field, an error message appears, and the input is not accepted. To proceed, modify the text, so that it follows the requirements. EZ2 Connect MDx User Manual 05/2022...
Page 65: Starting The Ez2
2. Press the power button. If sounds are enabled on the instrument, a sound is played as the instrument is switched on. The startup screen appears, and the instrument is initialized. After the initialization is done, the Login screen appears. EZ2 Connect MDx User Manual 05/2022...
Page 66 3 attempts by default), your account is locked. To activate your account, contact your administrator. If you are the only user with an administrator role and your account is locked, contact QIAGEN Technical Support. EZ2 Connect MDx User Manual 05/2022...
Page 67: Configuring The Ez2
2. Tap System configuration. Figure 35. System configuration tab. 3. To set the instrument name, tap the Instrument name field, and enter a name using the on- screen keyboard. To save the name, tap Accept. EZ2 Connect MDx User Manual 05/2022...
Page 68: Changing Instrument Settings
You can adjust the settings of the EZ2 according to your preferences. Note: Only Administrators can change Instrument settings. To modify Instrument settings, follow the steps below: 1. Tap Configuration on the toolbar. Figure 37. Configuration button on the toolbar. EZ2 Connect MDx User Manual 05/2022...
Page 69: Managing Users
EZ2 user management allows you to create and edit user accounts with two different roles: administrator and operator. When you use the EZ2 for the first time, a default user (Admin) is pre- installed and configured. Note: User management is only available to users with the administrator role. EZ2 Connect MDx User Manual 05/2022...
Page 70 Note: Only administrators can add new users. 1. Tap Configuration on the toolbar. Figure 39. Configuration button on the toolbar. 2. Tap User management. Existing users are shown in the table. Figure 40. The User Management tab. EZ2 Connect MDx User Manual 05/2022...
Page 71 Retype password field. The password must meet the criteria displayed in the dialog. To modify the password policy, refer to the Managing user security section (see page 77). Figure 42. Set user password dialog. EZ2 Connect MDx User Manual 05/2022...
Page 72 Note: Only administrators can edit user accounts. 1. Tap Configuration on the toolbar. Figure 43. Configuration button on the toolbar. 2. Tap User management. Existing users are shown in the table. Figure 44. The User Management tab. EZ2 Connect MDx User Manual 05/2022...
Page 73 5. To change the User role or User status, tap the respective drop-down lists and select an option. 6. To change the password of the user, tap Change password. The Change user password dialog appears. Figure 46. Change user password screen. EZ2 Connect MDx User Manual 05/2022...
Page 74 1. Tap Configuration on the toolbar. Figure 47. Configuration button on the toolbar. 2. Tap User management. Existing users are shown in the table. Figure 48. The User Management tab. EZ2 Connect MDx User Manual 05/2022...
Page 75: Changing Password
Editing an existing user account section (see page 72). Note: For cybersecurity reasons, an operator must change the password provided by the administrator upon first login. Note: Although not explicitly prohibited by the software operators should not re-use previous passwords. EZ2 Connect MDx User Manual 05/2022...
Page 76 1. Tap Configuration on the toolbar. Figure 49. The Configuration button on the toolbar. 2. Tap Edit. Figure 50. User Management tab (visible only for administrator roles). 3. Tap Change password. Figure 51. Change Password screen. EZ2 Connect MDx User Manual 05/2022...
Page 77: Managing User Security
Administrators only can change the password policy for all user roles, as well as change the settings for password expiration and limit incorrect login attempts. To modify settings related to user security, follow the steps below: 1. Tap Configuration on the toolbar. Figure 53. The Configuration button on the toolbar. EZ2 Connect MDx User Manual 05/2022...
Page 78: Installing New Protocols
Note: To ensure that your EZ2 has the latest protocol versions installed, please visit the EZ2 Connect MDx webpage at https://www.qiagen.com/de/products/ez2-connect-mdx/. Protocol versions can be found during the set-up wizard, step 2 of 7. EZ2 Connect MDx User Manual 05/2022...
Page 79 Important: Download software upgrades, protocol files, language packs, and other EZ2 related files only from www.qiagen.com. Important: Use only the USB flash drive provided by QIAGEN. Do not connect other USB flash drive devices to USB ports Important: Do not remove the USB drive while downloading or transferring data or software to or from the instrument.
Page 80: Language Settings
Important: Download software upgrades, protocol files, language packs, and other EZ2-related files only from www.qiagen.com. Important: Use only the USB flash drive provided by QIAGEN. Do not connect other USB flash drive devices to USB ports. Important: Do not remove the USB drive while downloading or transferring data or software to or from the instrument.
Page 81 Figure 59. Language Tab. 5. Tap Upload in Upload language packages window. 6. If language upload packages have been detected on the USB stick, a pop-up window appears. Figure 60. Language package pop-up window. EZ2 Connect MDx User Manual 05/2022...
Page 82: Updating Software
MDx webpage at https://www.qiagen.com/de/products/ez2-connect-mdx/. Currently installed software version can be found from the Configuration menu, under the System configuration tab. Important: Use only the USB flash drive provided by QIAGEN. Do not connect other USB flash drive devices to USB ports.
Page 83 4. Tap Check for updates to check the attached USB drive. 5. If a software update package has been detected on the USB stick, a pop-up window appears. Figure 63. Update package pop-up window. EZ2 Connect MDx User Manual 05/2022...
Page 84: Configuring Network And Qiasphere Base Connections
1. Tap Configuration on the toolbar. Figure 64. Configuration button on the toolbar. 2. Tap LAN. Figure 65. The LAN tab. 3. Enter the appropriate network setting, as obtained from your IT department. 4. Tap Accept. EZ2 Connect MDx User Manual 05/2022...
Page 85 The EZ2 can be connected to a Wi-Fi network using the Wi-Fi adapter inserted into one of the USB ports. The Wi-Fi adapter supports the 802.11b, 802.11g, and 802.11n Wi-Fi standards, and WEP, WPA-PSK, and WPA2-PSK encryption. EZ2 Connect MDx User Manual 05/2022...
Page 86 The SSID of the network must be visible. It is not possible to connect to a network with a hidden SSID. To configure the Wi-Fi connection, follow the steps below: 1. Tap Configuration on the toolbar. Figure 67. The Configuration button on the toolbar. 2. Tap Wi-Fi. Figure 68. The Wi-Fi tab. EZ2 Connect MDx User Manual 05/2022...
Page 87 5. To connect to the selected network, tap Connect. 6. Enter the network password using the on-screen keyboard and tap Connect. The instrument connects to the network, and the connection status is updated on the screen. Figure 70. On-screen keyboard. EZ2 Connect MDx User Manual 05/2022...
Page 88 To go back to the Wi-Fi tab, tap Back. To change the password, tap Change password. To disconnect from the network, tap Disconnect. Note: Configure the network in a way that makes the EZ2 instrument not visible outside the network of your organization. Figure 72. Network settings dialog. EZ2 Connect MDx User Manual 05/2022...
Page 89 For more details on the QIAsphere Base network configuration and how to connect to the EZ2, refer to the QIAsphere Base user manual which is available at www.qiagen.com. Only users assigned the role Administrator can change the network configuration. It is recommended to consult your network administrator when configuring the network.
Page 90 Important: Do not remove the USB drive while downloading or transferring data or software to or from the instrument. The EZ2 Connect MDx can be connected with a LIMS system, the connection can be configured from the Configuration menu under the LIMS tab and by completing the following steps: Upload the LIMS Connector certificate ...
Page 91 In some rare cases, you might need to re-upload the QIAGEN LIMS Connector certificate. This certificate was originally generated by the QIAGEN Service Team during the LIMS Connector set up and was saved on a USB drive. The certificate is designed locally and cannot be provided remotely.
Page 92 4. Tap Upload new. Figure 77. Select certificate screen. 5. Select the certificate and tap Update. Figure 78. Successful certificate update. 6. Tap OK and restart the EZ2. EZ2 Connect MDx User Manual 05/2022...
Page 93 8. Tap OK. 9. Install the generated certificate from the USB stick on the QIAGEN LIMS Connector. 10. Tap the QIAGEN LIMS Connector URL box to enter the URL using the on-screen keyboard. Figure 80. Enter LIMS Connector URL. EZ2 Connect MDx User Manual 05/2022...
Page 94 If the instrument is registered, and only LIMS Connector address was changed, you can enter a new URL and tap Skip. 13. If you want to select a new configuration, you can also tap Register in the LIMS configuration tab. Figure 82. LIMS registration. EZ2 Connect MDx User Manual 05/2022...
Page 95 14. Select configuration from the drop-down list and tap Register. Figure 83. LIMS registration successful. 15. Tap OK, then tap Test connection. Figure 84. LIMS connection test. EZ2 Connect MDx User Manual 05/2022...
Page 96 LIMS after the run. This setting does not change after the instrument restart. Note: If the user disables the Send results to LIMS box the following warning is displayed. Figure 86. Disable sending results warning. EZ2 Connect MDx User Manual 05/2022...
Page 97 18. Status icon: The results sending status table is empty when all results have been successfully sent and nothing is queued to be sent. The user sees the LIMS results status icon with a checkmark. EZ2 Connect MDx User Manual 05/2022...
Page 98 Results with the Sending status are currently being sent to the LIMS system. Results with Pending status are queued and waiting to be sent. The user also sees the LIMS results status icon with the cached symbol. EZ2 Connect MDx User Manual 05/2022...
Page 99 If the results cannot be sent, sending status table informs the user about the unsent status and occurred error. The Unsent status is displayed with an error ID and detailed description. The user also sees the LIMS results status icon with the warning symbol. EZ2 Connect MDx User Manual 05/2022...
Page 100: Setting Up A Protocol Run
To setup a protocol run, press the Setup tab on the Home screen. All available QIAGEN protocols are pre-installed on the EZ2 upon delivery. You can download all available QIAGEN protocols from the QIAGEN website. For MDx applications, choose the IVD mode when logging in.
Page 101 LIMS button on the Set-Up tab. The LIMS button only is available if LIMS was configured before. Important: Before starting a protocol run, read the relevant QIAGEN kit handbook and follow the instructions (e.g., on sample storage, handling, and preparation) provided in the handbook.
Page 102: Scanning Q-Card Bar Code
Figure 92. Setup screen. Tap into the field showing up in the next screen and scan the 1D Barcode on the Q-Card provided with the kit. Figure 93. Scan the Q-Card barcode screen. EZ2 Connect MDx User Manual 05/2022...
Page 103 By scanning the 1D Barcode on the Q-Card provided with the kit, the application type is selected and information on script options is given. See the Using the bar code scanner section (see page 132). Figure 95. Select protocol screen. EZ2 Connect MDx User Manual 05/2022...
Page 104: Defining Parameters
Note: The description on the GUI is supportive only. Please ensure you to read the respective information in the kit handbook. To proceed to the Select sample positions step, tap Next. To return to the previous screen, tap Back. EZ2 Connect MDx User Manual 05/2022...
Page 105: Selecting Sample Positions
The selected positions are highlighted. To select or deselect all positions, tap the Select all toggle. Figure 97. Select sample positions screen. Figure 98. Select sample positions step. EZ2 Connect MDx User Manual 05/2022...
Page 106: Entering Sample Ids
Note: When using the handheld barcode scanner to input the sample IDs, the operator must ensure that the barcode used is of appropriate type and quality to be read by the scanner. Figure 99. Enter sample IDs step (two IDs auto generated). EZ2 Connect MDx User Manual 05/2022...
Page 107 There is an 80-character limit for the Sample ID field. Tap Accept to save the changes, or tap Cancel to go back to the Enter sample IDs screen. Note: Samples IDs must be unique. The NEXT button is not active until unique sample IDs have been entered for all samples. EZ2 Connect MDx User Manual 05/2022...
Page 108 Cancel to go back to the Enter sample IDs screen. To proceed to the Load the cartridge rack step, tap Next. To return to the previous screen, tap Back. To cancel the protocol, tap Cancel. EZ2 Connect MDx User Manual 05/2022...
Page 109: Loading The Cartridge Rack
Figure 102. Load the cartridge rack step. To proceed to the Load the tip rack step, tap Next. To return to the previous screen, tap Back. To cancel the protocol, tap Cancel. EZ2 Connect MDx User Manual 05/2022...
Page 110: Loading The Tip Rack
Note: In some applications, not all positions of the labware holder are to be used. This is indicated by the lack of this position on the left-hand side and a white circle on the right-hand side. EZ2 Connect MDx User Manual 05/2022...
Page 111 The system checks available disk space when the protocol run is started. If the available space is lower than that required for 5 runs, a warning message is displayed. Figure 105. Low disk space. Previous run reports should be downloaded and deleted to free up disk space. EZ2 Connect MDx User Manual 05/2022...
Page 112: Lims Workflow
This application layer contains all specific parameters of the respective protocol. During the LIMS connection set-up service, ensure that you cover with the QIAGEN service person all protocols you intend to use, to get the needed application layers created during this setup.
Page 113 Figure 108. Scan or enter sample ID. 4. After scanning the first sample the check parameters and load the holder screen is displayed. Figure 109. Check parameters and load the holder screen. EZ2 Connect MDx User Manual 05/2022...
Page 114 (optional). Also, samples which have not been found in LIMS can be processed. Note: If the Sample ID fields contain scanned sample IDs found in LIMS, these fields are not editable. Figure 111. Review collected samples. EZ2 Connect MDx User Manual 05/2022...
Page 115 To highlight the well on the diagram and the corresponding row in the table, tap the well or the table row. Important: Read the instructions carefully before loading the rack, and make sure to follow all directions including those in the respective kit handbook. Figure 113. Load the cartridge rack. EZ2 Connect MDx User Manual 05/2022...
Page 116 Important: Read the instructions carefully before loading the rack, and make sure to follow all directions including those in the respective kit handbook. Figure 114. Load the holder. 9. Tap Next to proceed to the run overview screen. Figure 115. Run set-up overview. EZ2 Connect MDx User Manual 05/2022...
Page 117 12. The system checks available disk space when the protocol run is started. If the available space is lower than that required for 5 runs, a warning message is displayed. Figure 117. Low disk space. Previous run reports should be downloaded and deleted to free up disk space. EZ2 Connect MDx User Manual 05/2022...
Page 118: Canceling The Protocol Run Setup
After successfully completing all the steps of the protocol run setup, you can start the run. During the protocol run, you can monitor its progress. Ongoing steps, an estimated run time, and the elapsed run time are displayed on the screen. EZ2 Connect MDx User Manual 05/2022...
Page 119 Note: The Estimated run time does not include the time to complete the Load Check, which is approximately 6 minutes. 3. If the hood of the instrument is open, close it and the run will start. Figure 120. Close the hood dialog. EZ2 Connect MDx User Manual 05/2022...
Page 120 If the instrument is left unattended for an extended time period, stability of samples and reagents may be impaired. Figure 121. Load check in progress screen. EZ2 Connect MDx User Manual 05/2022...
Page 121: Load Check
5.6.1 Load check The EZ2 Connect MDx comes with a built-in camera, which is designed as an aid to ensure the operator has loaded all of the cartridges and labware into the correct positions on the worktable. However, the contents of the labware (e.g., liquid levels) in the tip rack are not checked, so the operators must make sure that they have carefully followed the instructions related to the protocol being run.
Page 122 Distinguish between empty tip holder and elution/reagent/sample tube  Distinguish between capped tube and tip holder with tip  Distinguish between tip holder (without tip) and tube  Distinguish between tip holder (without tip) and tip holder with tip  EZ2 Connect MDx User Manual 05/2022...
Page 123 Note: In case of repeated load check failure, please recalibrate the camera (refer to Section 6.6). Contact QIAGEN Technical Support for additional support. During this time samples should be removed from the worktable and held at appropriate storage conditions.
Page 124 Load check failed screen (Figure 123) is still open. If you press Back, the information about the failed positions will not be visible again. Once correct loading is confirmed, tap Next to proceed to the Run setup selection overview screen where the Skip load check button will now be available. EZ2 Connect MDx User Manual 05/2022...
Page 125 Figure 125. Skip load check option. Figure 126. Confirm skip load check screen. EZ2 Connect MDx User Manual 05/2022...
Page 126: End Of The Protocol Run
Home screen. After a run is finished, a run report is generated. For more information on how to save and download a run report, refer to the Saving a run report section (page 128). Figure 127. Protocol run completed screen. EZ2 Connect MDx User Manual 05/2022...
Page 127: Aborting A Protocol Run
4. Tap Finish to end the run and go back to the Home screen. A run report is generated. For more information on how to save a run report, refer to the Saving a run report section (see page 128). EZ2 Connect MDx User Manual 05/2022...
Page 128: Saving A Run Report
An EZ2 run report is created by the software application after a run is completed, aborted or if it fails, after the user taps the Finish button on the screen that is shown after a run ends. EZ2 Connect MDx User Manual 05/2022...
Page 129: 5.10 Setting Up The Worktable
These actions are described in the Loading the cartridge rack and Loading the tip rack screens of the protocol run setup process, and in the kit handbooks. EZ2 Connect MDx User Manual 05/2022...
Page 130: 5.10.1 Loading And Unloading The Cartridge Rack
Hazardous materials and infectious agents The waste contains samples and reagents. This waste may contain toxic or infectious material and must be disposed of properly. Refer to your local safety regulations for proper disposal procedures. EZ2 Connect MDx User Manual 05/2022...
Page 131: 5.10.2 Loading And Unloading The Tip Rack
Important: Make sure to timely remove eluates from the instrument after the run has finished and store as indicated in the corresponding kit handbook. The eluates are exposed to ambient temperature in the EZ2 instrument and extended time before removal may cause nucleic acid degradation. EZ2 Connect MDx User Manual 05/2022...
Page 132: 5.11 Using The Bar Code Scanner
Direct the handheld scanner at the required Q-Card/Barcode or sample bar code to scan the information into the Instrument when prompted by the User Interface. Note: Barcode information may also be entered manually. EZ2 Connect MDx User Manual 05/2022...
Page 133: 5.12 Data Menu
5.12 Data menu Important: Use only the USB flash drive provided by QIAGEN. Do not connect other USB flash drive devices to USB ports. Important: Do not remove the USB drive while downloading or transferring data or software to or from the instrument.
Page 134: Run Reports
If there is currently no run report on the instrument, the Download, and the Download and delete buttons are disabled. Tap either one of the available options below: All run reports  Recent reports, for this option you should also specify the number of reports  EZ2 Connect MDx User Manual 05/2022...
Page 135 Figure 134. Download reports in progress. Figure 135. Report download successful. If Download and delete is selected, the following screen is displayed prior to start of the delete process. Figure 136. Confirm delete run reports. EZ2 Connect MDx User Manual 05/2022...
Page 136 Figure 137. Run reports deleted confirmation. Tap OK to complete process. If no USB drive is inserted, the following screen is displayed: Figure 138. USB drive not inserted. Insert a USB drive and attempt the process again. EZ2 Connect MDx User Manual 05/2022...
Page 137: Support Package
Note: Download of Audit trail file is only available to Admin users. Tap Download, alongside the Audit trail section of the Data screen. The following screen is displayed: Figure 139. Download audit trail in progress. Figure 140. Audit trail download successful. EZ2 Connect MDx User Manual 05/2022...
Page 138: 5.13 Logging Out And Switching The Instrument Off
Important: It is not recommended to switch the instrument off when a protocol run, maintenance procedure, or file transfer are in progress. This could result in damage to the instrument and samples and/or data may be lost. Figure 142. Location of the Log out button. EZ2 Connect MDx User Manual 05/2022...
Page 139: 5.14 Research Mode
To start the EZ2 Connect MDx in Research mode, select Research Mode at the log-in screen  If this is the first time use of the EZ2 Connect MDx, use Admin as User ID and Password, Tap  Log in to launch the software Figure 143.
Page 140 (see page 100) for further details. Note: Using the EZ2 Connect MDx in Research mode gives the option to skip the initial Load Check. When skipping the load check, the instrument will not check the worktable setup but immediately start the protocol run.
Page 141: Maintenance Procedures
Instrument Service Specialists only information contact QIAGEN Technical Services. Optionally, a UV decontamination procedure may be performed as required to reduce pathogen and nucleic acid contamination. See section UV decontamination (page 155) for further details. EZ2 Connect MDx User Manual 05/2022...
Page 142: Cleaning Agents
Mikrozid AF sensitive (www.schuelke.com), or 70% ® ethanol. 70% ethanol can be used on the worktable. The hood and touchscreen should ONLY be cleaned with lint free tissue moistened with water. EZ2 Connect MDx User Manual 05/2022...
Page 143 When using ethanol or ethanol-based liquids to clean the EZ2, handle such liquids carefully and in accordance with the required safety regulations. If any liquid spills, wipe it off and leave the EZ2 hood open to allow flammable vapors to disperse. EZ2 Connect MDx User Manual 05/2022...
Page 144: Disinfecting The Ez2
® cat. no AM9780) can be used for cleaning surfaces and submerging worktable items. RNaseZap can also be used to perform decontamination by spraying worktable items, if they have been removed from the instrument. EZ2 Connect MDx User Manual 05/2022...
Page 145: After Run Maintenance
After run maintenance is required after each run of the EZ2. The EZ2 must only be operated by qualified personnel who have been appropriately trained. Servicing of the EZ2 must only be performed by QIAGEN Field Service specialists. WARNING Moving parts To avoid contact with moving parts during the operation of the EZ2, the instrument must be operated with the hood closed.
Page 146 Note: Make sure that the eluates have been retrieved and stored according to the respective kit handbook before performing after run maintenance. 1. Remove all sample preparation waste and discard it according to your local safety regulations. 2. Close the hood. EZ2 Connect MDx User Manual 05/2022...
Page 147 6. Carefully wipe the piercing unit using a lint-free tissue moistened with 70% ethanol. Enclose individual piercing spike with the tissue, apply firm pressure and twist several times. Repeat for all piercing spikes. Figure 147. Cleaning the EZ2 piercing unit. EZ2 Connect MDx User Manual 05/2022...
Page 148: Daily Maintenance
Moving parts To avoid contact with moving parts during the operation of the EZ2, the instrument must be operated with the hood closed. If the hood sensor or lock is not functioning correctly, contact QIAGEN Technical Services WARNING Moving parts Avoid contact with moving parts during operation of the EZ2.
Page 149 1. On the touchscreen, tap Maintenance. 2. Tap Daily. The date of the last finished procedure is shown on the screen. Figure 148. Daily maintenance screen. EZ2 Connect MDx User Manual 05/2022...
Page 150 8. To allow tray removal, tap Move to back. 9. Clean the tray with 70% ethanol, and then with distilled water. Note: After removal of the tray for cleaning purposes, ensure it is correctly reinstalled. Figure 149-A Right side tray installed. EZ2 Connect MDx User Manual 05/2022...
Page 151 10. Wipe the cartridge and tip racks with 70% ethanol, and then with distilled water. 11. Wipe the surface of the instrument using a lint-free tissue moistened with 70% ethanol. Note: The hood and touchscreen should ONLY be cleaned with lint free tissue moistened with water. EZ2 Connect MDx User Manual 05/2022...
Page 152: Weekly Maintenance
1. On the touchscreen, tap Maintenance. 2. Tap Weekly maintenance. The date of the last procedure, and the date of the next due date of the weekly maintenance are shown on the screen. EZ2 Connect MDx User Manual 05/2022...
Page 153 6. Apply a small amount of silicon grease (see Appendix B – EZ2 Connect MDx Accessories, Ordering Information, page 170) onto the inner wall of the large end of a fresh filter-tip by using the fine end of a second fresh tip.
Page 154 Excess or insufficient grease can affect the performance of the EZ2. Note: The opening in the nub of the pipettor should be checked after greasing to ensure no grease is present within the opening. Figure 152. Placing a filter-tip onto the pipettor head. EZ2 Connect MDx User Manual 05/2022...
Page 155: Uv Decontamination
Avoid looking directly into UV light. Do not expose your skin to UV light. Important: Before starting the UV decontamination, complete the Daily maintenance (see page 145). 1. Close the hood. 2. On the touchscreen, tap Maintenance. EZ2 Connect MDx User Manual 05/2022...
Page 156 1 or 2 min. 7. A message (see the figure hereafter) is displayed after execution of the UV Run. Tap Finish to complete the UV Run. Figure 154. UV run finished screen. EZ2 Connect MDx User Manual 05/2022...
Page 157: Camera Calibration
Camera calibration The EZ2 Connect MDx provides an internal camera which allows an inventory scan prior to run execution. Note: The camera calibration should be performed as part of installation procedure, after moving the instrument, as well as in case of load check issues.
Page 158: Servicing
Contact your local QIAGEN Technical Services or your local distributor for more information about flexible Service Support Agreements from QIAGEN. Note: Before service of the EZ2 Connect MDx can be performed, the instrument must first be decontaminated. Refer to Disinfecting the EZ2 and Removing contamination sections (pages 144 and 144, respectively).
Page 159: Troubleshooting
Support package  This information will help you and QIAGEN Technical Services deal most efficiently with your issue. Note: Information about the latest software and protocol versions can be found at www.qiagen.com. In some cases, updates may be available for addressing specific problems.
Page 160 5. The support package is now saved on the USB flash drive. The download successful screen is displayed. Tap OK to close. Note: The support package contains information about the last performed runs and hence can contain sensitive information. Figure 158. Download successful status. EZ2 Connect MDx User Manual 05/2022...
Page 161 6. If creation of the support package is not possible, the screen below is displayed and the creation should be attempted again. Figure 159. Support package creation failure status. Note: The support package contains information about the last performed runs and hence can contain sensitive information. EZ2 Connect MDx User Manual 05/2022...
Page 162: Operation
Start UV decontamination. Make sure samples and cartridge rack were handled properly. Software/protocol update Restart the device and try to start the update again. Make sure you use the QIAGEN USB fails flash drive. USB flash drive should stay plugged in during the whole update procedure.
Page 163: Glossary
Error code A number that represents an error of the EZ2. EZ2 kits Kits supplied by QIAGEN containing reagents, reagent cartridges and plasticware for use with EZ2 instruments. Filter-tip Labware that is picked up by a tip adapter during operation of the EZ2. Liquid is aspirated into and dispensed from a filter-tip.
Page 164: Technical Specifications
Technical Specifications QIAGEN reserves the right to change specifications at any time. Operating conditions Power 100−240 V AC, 50/60 Hz, 1000 VA Mains supply voltage fluctuations are not to exceed 10% of nominal supply voltages. Fuse AC Inlet: T4A H 250 V...
Page 165: Mechanical Data And Hardware Features
Capacity of 50–1000 μl. Capacity of 50–1000 μl. The EZ2 accommodates up to 48 tip holders in 2 rows, each containing a filter-tip, in the tip rack on the worktable. EZ2 Connect MDx User Manual 05/2022...
Page 166 Height: 34 mm (1.34 in.) Depth: 39 mm (1.54 in.) Network Wi-Fi: Designed for usage with Wi-Fi adapter provided by QIAGEN. The Wi-Fi adapter supports the 802.11b, 802.11g, and 802.11n Wi-Fi standards, and WEP, WPA- PSK, and WPA2-PSK encryption. Supports LAN...
Page 167: Declaration Of Conformity
Appendix A Declaration of Conformity Name and address of the legal manufacturer QIAGEN GmbH QIAGEN Strasse 1 40724 Hilden Germany An up-to-date declaration of conformity can be requested from QIAGEN Technical Services. EZ2 Connect MDx User Manual 05/2022...
Page 168: Waste Electrical And Electronic Equipment (Weee)
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 169: California Proposition 65 Warning
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 170: Appendix B - Ez2 Connect Mdx Accessories
9027102 For up-to-date licensing 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. EZ2 Connect MDx User Manual 05/2022...
Page 171: Document Revision History
Document Revision History Date Changes 04/2022 Initial version of the EZ2 Connect MDx User Manual EZ2 Connect MDx User Manual 05/2022...
Page 172 (Schülke & Mayr GmbH). Registered names, trademarks, etc. used in this document, even when not specifically marked as such, are not to be considered unprotected by law. HB-2907-001 05/2022 © 2022 QIAGEN, all rights reserved. EZ2 Connect MDx User Manual 05/2022...
Page 173 Ordering www.qiagen.com/contact | Technical Support support.qiagen.com | Website www.qiagen.com EZ2 Connect MDx User Manual 05/2022 1124548 05/2022 HB-2907-001...

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