Qorvo OMNIA Operator's Manual
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Qorvo OMNIA Operator's Manual

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OPERATOR MANUAL
BIOTECHNOLOGIES
OMNIA SYSTEM OPERATOR MANUAL

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Summary of Contents for Qorvo OMNIA

  • Page 1 OPERATOR MANUAL BIOTECHNOLOGIES OMNIA SYSTEM OPERATOR MANUAL...
  • Page 2 © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
  • Page 3 OPERATOR MANUAL OPERATOR MANUAL BIOTECHNOLOGIES BIOTECHNOLOGIES Qorvo Biotechnologies Omnia System Operator Manual FOR EMERGENCY USE AUTHORIZATION ONLY In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories;...

  • Page 4: Table Of Contents

    RETURNING THE INSTRUMENT FOR SERVICE..........................27 INSTRUMENT DISPOSAL..................................28 INSTRUMENT DIMENSIONS................................28 POWER SUPPLY....................................28 INPUT/OUTPUT CONNECTIONS................................28 OPERATING CONDITIONS...................................28 SHIPPING/STORAGE CONDITIONS ..............................28 CONNECTIVITY.....................................28 PROBLEM SOLVING.....................................29 TECHNICAL SUPPORT..................................32 DOCUMENT VERSION..................................32 © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.

  • Page 5: Overview Of Qorvo Omnia System

    BIOTECHNOLOGIES OVERVIEW OF OMNIA SYSTEM The Qorvo Biotechnologies Omnia system is a device for measuring biomarker concentrations from a human sample. The Qorvo Omnia system consists of an instrument, on-board software, and single-use test cartridges. The instrument (Figure 1) contains all hardware, software, and mechanical components necessary for full automation of biomarker detection.

  • Page 6: Symbols And Labels

    The instrument has a label on the bottom. The label contains information specific to each instrument (serial number), part number and information related to instrument storage and use environments. © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.

  • Page 7: Specimen Precautions

    3. Remove the instrument from its box and place on a level surface. 4. Attach the DC power cable to the back of the instrument. Use only the Omnia system power supply – any other power supply may damage the instrument and void the warranty.

  • Page 8: Graphic User Interface

    BIOTECHNOLOGIES GRAPHIC USER INTERFACE The graphic interface on the Qorvo Omnia system guides the user through the process of entering the required information for each cartridge, preparing the cartridge and running the test. After the instrument is powered up, it takes about five minutes for the required internal temperature to be reached. The start-up screen (Figure 3) will be present until the operating temperature is reached.
  • Page 9 OPERATOR MANUAL BIOTECHNOLOGIES Login Username Password Enter Figure 4 After Log In, the Main Menu will appear (Figure 5). From the Main Menu, the operator may select “Start New Test” to begin a new diagnostic test; “Settings” to manage instrument and network settings; or “Logout.” Current User: admin Start New Test Settings...
  • Page 10 If the operator is a user without administration credentials, the following screen is visible (see Figure 6b). System Settings System Settings About Database Network Update Audio Date & Time Printer Admin Display Event Log Reports Cartridge Back Back Figure 6b © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
  • Page 11 OPERATOR MANUAL BIOTECHNOLOGIES Settings screens for users without administrator privileges First, the Settings screen for non-administrator users will be described. The About screen provides information on the instrument and associated software. The total time the system has been on and number of cartridges run by the instrument are also captured (See Figure 7). System Settings About About...
  • Page 12 Jul 20 14:22:54 RDXI local1.notice veyron: 40 DateTime Jul 20 14:22:54 RDXI local1.notice veyron: 40 SetuoMenu Jul 20 14:22:51 RDXI local1.notice veyron: 40 Diagnostics Download Back Back Figure 10 © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
  • Page 13 OPERATOR MANUAL BIOTECHNOLOGIES The Printer screen permits the user to configure print results automatically (See Figure 11). If “Auto-Print Results” is turned On, test results will be printed automatically following the test completion, provided a printer is connected. Monday 4/13/2020 18:30 System Settings System Settings...
  • Page 14 Check the “Auto-Send After Measurement” to enable this feature. Auto-Send After Measurement DATA FORWARDING None Results to USB Diags to USB Send Back Figure 14 © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
  • Page 15 OPERATOR MANUAL BIOTECHNOLOGIES The Date and Time screen allows the user to set the current date and time (see Figure 15). System Settings System Settings Date & Time Database Network About Update Auto 2021 Audio Date & Time Printer 24-Hour Display Event Log Reports...
  • Page 16 OPERATOR MANUAL BIOTECHNOLOGIES The Qorvo Omnia system may be connected to the internet via Ethernet or Wi-Fi. The Qorvo Omnia system is Wi-Fi enabled. To configure Wi-Fi access, use the Network screen. Changing the network settings requires administrator credentials (see Figure 17).
  • Page 17 OPERATOR MANUAL BIOTECHNOLOGIES Wi-Fi Update Database Network Selected Network: ATT-WIFI-ejpE Password* Date & Time Printer Event Log Reports Figure 17b Press IP Settings button to bring up the IP Settings pop-up panel (Figure 18). Here, you may configure the IP settings for either automatic or manual mode.
  • Page 18 Audio Date & Time Printer demo Lab Tech Demo User Display Event Log Reports Edit Delete Back Back Back Back Back Back Figure 20 © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
  • Page 19 OPERATOR MANUAL BIOTECHNOLOGIES Pressing the “Add” button will bring up the Add/Edit User screen (Figure 21). The controls in this screen may be used to add a new user or remove a user. The User Type may be a user with administrator rights or a normal user. Add/Edit User About Database...
  • Page 20 Event Log Reports Edit Delete Back Back Back Back Back Back Figure 23 This concludes the description of items selectable from the Settings screen. © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.

  • Page 21: Starting A New Test

    OPERATOR MANUAL BIOTECHNOLOGIES STARTING A NEW TEST From the Main Menu press “Start New Test”. The Patient Information screen appears, and the following patient information associated with the sample must be entered (Figure 24a): 1. Patient Name 2. Patient ID 3.

  • Page 22: Running A Test

    4. Place cartridge on flat surface. 5. Press “Next” when ready to proceed. The screen in Figure 26 will appear. © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
  • Page 23 Next Figure 26 6. Refer to the test cartridge Instructions For Use to dispense sample into the sample port. Each Qorvo Omnia test kit provides the necessary ancillary equipment to safely and accurately load the specimen. 7. Ensure all sample has been absorbed into the sample port and the sample has reached the “minimum sample fill”...
  • Page 24 The RFID tag informs the instrument which assay to run and informs the user which sample types are compatible with the selected cartridge (Figure 29). Note: The assay information in Figure 29 is an example only. Refer to Qorvo Omnia test cartridge Instructions for Use for assay-specific information.
  • Page 25 OPERATOR MANUAL BIOTECHNOLOGIES 10. Once the cartridge is read and identified, the user may be required to select the sample type as shown in Figure 30. Press “Select Source” or the down arrow to select the sample type from the pull-down display for the assay.
  • Page 26 Dispose of the used cartridge as biological waste. John Doe D.O.B: 05/19/2020 ID: 0000 Gender: Male Clinician: Dr. Smith Operator ID: JDoe Testing Sample 18% Complete Cancel Figure 32 © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
  • Page 27 OPERATOR MANUAL BIOTECHNOLOGIES Test results will be displayed immediately after cartridge is ejected. Figure 33 is an example only. See the Qorvo Omnia test cartridge instructions for Use for information on interpretation of results. John Doe D.O.B: 05/19/2020 ID: 0000...
  • Page 28 To Power Off, press and hold the Power button for 5 seconds (Figure 36) Are you sure you want to power off? Cancel Power Off Figure 36 © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.

  • Page 29: Periodic Maintenance And Service

    Plug in the DC power cable into the receptacle at the rear of the instrument. RETURNING THE INSTRUMENT FOR SERVICE For technical support questions or if the instrument needs to be returned for service, please contact Qorvo Biotechnologies Technical Support: Toll-Free: 1.833.384.1522...

  • Page 30: Instrument Disposal

    2. Storage temperature: 0-45°C (32-113°F) CONNECTIVITY Network connectivity for the Qorvo Omnia instrument may be established in two ways: (1) Ethernet and (2) Wi-Fi. Regardless of the method chosen, it is not necessary to log in to an enterprise network to establish connectivity.

  • Page 31: Problem Solving

    BIOTECHNOLOGIES Wi-Fi The Omnia instrument supports WPA2-PSK (Personal) Wi-Fi network protocol. Enterprise networking via Wi-Fi is not supported at present. To connect to Wi-Fi, make sure that there is a WPA2-PSK network in the area where you wish to connect. If there is no existing Wi-Fi network, you may establish a network using a smart phone and the hot-spot feature of the phone.
  • Page 32 Does the local network require a proxy server for Internet access? If yes, contact your local IT support team and ask for a workaround, as the Qorvo Omnia instrument does not support use of a proxy service, otherwise continue to step 2(d).
  • Page 33 0050 Instrument is The instrument cannot be tilted during measurement. Ensure the instrument is Tilted within 30 degrees of level. Repeat the test with a new cartridge. Contact Qorvo Technical Support if the error persists. 0060 Instrument The instrument is too hot to perform a measurement. Check that the fan filter is Temperature clean and not blocked.

  • Page 34: Technical Support

    OmniaCOVID19Test@qorvo.com DOCUMENT VERSION Document Number: QPR9002-PK191 Revision: F Date: August 2021 SAP Number: QPR9002OM.02 Dymo® and LabelWriter® are registered trademarks of Newell Brands, Inc. © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
  • Page 35 OPERATOR MANUAL BIOTECHNOLOGIES 33 of 33...
  • Page 36 BIOTECHNOLOGIES WWW.QORVOBIOTECH.COM © 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.

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