Qorvo OMNIA User manual

OPERATOR MANUAL
BIOTECHNOLOGIES
OMNIA SYSTEM OPERATOR MANUAL
BIOTECHNOLOGIES

© 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.

BIOTECHNOLOGIES
OPERATOR MANUALOPERATOR MANUAL
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Qorvo Biotechnologies OmniaTM
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; use by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements to
perform moderate or high complexity tests.
This product has been authorized only for the detection of proteins from SARS-CoV-2 and not for any other viruses or
pathogens; and, in the USA, the emergency use of this product is only authorized for the duration of the declaration
that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or
diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1), unless the
declaration is terminated or the authorization is revoked sooner.

OPERATOR MANUAL
BIOTECHNOLOGIES
© 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
OVERVIEW OF QORVO OMNIA SYSTEM...............................................................................................................................................3
COMPONENTS IN THE BOX...................................................................................................................................................................3
WARNINGS..............................................................................................................................................................................................3
SYMBOLS AND LABELS........................................................................................................................................................................4
INSTRUMENT LABELS..........................................................................................................................................................................4
SPECIMEN PRECAUTIONS....................................................................................................................................................................5
EXTERNAL QUALITY CONTROL............................................................................................................................................................5
INSTRUMENT INSTALLATION..............................................................................................................................................................5
PRINTER INSTALLATION......................................................................................................................................................................5
BARCODE SCANNER.............................................................................................................................................................................5
USING THE TOUCH SCREEN................................................................................................................................................................5
GRAPHIC USER INTERFACE.................................................................................................................................................................6
STARTING A NEW TEST.......................................................................................................................................................................19
RUNNING A TEST.................................................................................................................................................................................20
PERIODIC MAINTENANCE AND SERVICE.........................................................................................................................................27
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

BIOTECHNOLOGIES
OPERATOR MANUAL
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.
The test cartridge (Figure 2) consists of two preassembled parts: a main cartridge body and a reagent carousel. All
the liquid reagents required for the test are contained in the reagent carousel. The liquid reagents on the carousel
are automatically moved in interface between the cartridge and instrument. During a test, the sample is added
to the cartridge sample port up to the fill line and the user inserts the cartridge into the instrument following the
indicator arrow on the cartridge. When inserted, the instrument recognizes the test type and other relevant cartridge
information by reading a Radio Frequency Identification (RFID) tag permanently axed to the cartridge. The user
follows the prompts on the screen to initialize the test.
For detailed instructions on running a diagnostic test, refer to the Instructions for Use for each diagnostic assay.
COMPONENTS IN THE BOX
• Instrument (1)
• Power Supply (1)
• Operator Manual (1)
• Quick Start Guide (1)
• Replacement Air Filters (5)
WARNINGS
Read these instructions completely before using the product.
1. For in vitro diagnostic and Laboratory Professional use.
2. The Omnia System is FOR EMERGENCY USE AUTHORIZATION ONLY
3. Read all instructions completely and carefully follow all instructions. Failure to follow all instructions may
result in inaccurate test results.
Figure 1 Figure 2
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OPERATOR MANUAL
BIOTECHNOLOGIES
© 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
SYMBOLS AND LABELS
The following symbols are found on the Qorvo Omnia system and cartridges:
INSTRUMENT 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.
Symbol Explanation
Protect instrument from moisture
User to consult the instructions for use
Indicates the temperature range for use/storage
Indicates serial number so that the device can be identified
Indicates the manufacturer’s catalogue number so the device can be identified
Indicates the date after which the cartridge is not to be used (expiration date)
Indicates that the cartridge is intended for single use
Indicates possible biological risk
In vitro Diagnostic Medical Device
Underwriter Labs Approved
For prescription use only
REF
SN
IVD

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SPECIMEN PRECAUTIONS
1. Specimens may be infectious. Use universal precautions when performing any testing on the Qorvo
Omnia System.
2. Use routine laboratory precautions. Do not eat, drink, or smoke in the area where samples are being handled
and testing is being conducted. Avoid any contact between hands, eyes or mouth during sample collection
and testing.
3. Wear personal protective equipment (PPE) in accordance with laboratory and institutional policies, such as
laboratory coats, disposable gloves, and eye protection when handling patient samples.
4. Wash hands thoroughly after handling specimens and used cartridge.
EXTERNAL QUALITY CONTROL
External quality control solutions are used to demonstrate that the test cartridge and the Qorvo Omnia System are
operating properly. The use of external quality controls after installation are recommended where appropriate.
Refer to the Quality Control section of each test cartridge’s Instructions for Use for specific guidance.
INSTRUMENT INSTALLATION
1. The instrument should be placed in a clean, well-ventilated area. The instrument has a small footprint
(10”x9”x5”) with minimal space required.
2. At least a 5 cm (2 inches) circumference surrounding the instrument should be maintained to allow for
enough ventilation.
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.
5. Plug the grounded AC power cable into the provided DC power supply and then into a grounded
electrical outlet.
6. To power up the instrument, press the power button on the top of the instrument. It takes approximately five
minutes to reach required internal temperature (37°C/99°F). Once operating temperature is reached, the start-
up screen will be visible. It is recommended to leave the instrument on for the period of the working day. To
power down the instrument, press the power button again (for a minimum of three seconds).
PRINTER INSTALLATION
The Qorvo Omnia system is compatible with the DYMO® LabelWriter® 450 printer. The printer is connected to the
Qorvo Omnia system via the USB port.
Label type: DYMO LabelWriter Address Printer Labels, 1 1/8” x 3 1/2”
DYMO label part number: 30252
BARCODE SCANNER
A USB barcode scanner may be used to enter text.
Recommended Scanner: Motorola/Zebra DS4308-HD7U2100AZW
USING THE TOUCH SCREEN
1. Do not rest your hand on the touch screen.
2. Tap screen gently.
3. Never touch the screen with a sharp or abrasive object.

OPERATOR MANUAL
BIOTECHNOLOGIES
© 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
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.
Logging in and Main Menu
After initialization, the Log In screen will appear (Figure 4). At the Log In screen, enter your user credentials. If you
are setting up the instrument for the first time, the username “admin” and user password “admin” (both lower case)
credentials will be needed to log in. After logging in with the admin/admin credentials, the system will require you
to create a new password for the admin user name. After you enter the new password, the system will return you to
the Main Menu. From the Main Menu, press “Settings” and then “Admin” to bring up the administrator panel where
you may create new user names and passwords. Be sure to create user credentials for each expected operator of
the system and record those credentials. The initial admin/admin login credentials do not permit the operator to run
tests. New user credentials may be created by pressing “Settings” at the Main Menu, and then “Admin”. After creating
the user logins, log out and log back in as one of the newly created users.
Figure 3

BIOTECHNOLOGIES
OPERATOR MANUAL
Login
Enter
Username
Password
Figure 4
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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.”
The instrument is now installed, powered up and the user is logged in. Operation of the instrument is described in
sections below.
1. Settings – this section describes how to set up the instrument’s System Settings such as Display, Data & Time,
Event Log, Printer, Reports and more.
2. Starting a New test – this section walks the user through cartridge preparation, performing a test and
printing the results.
3. Log out.
Start New Test
Current User: admin
Settings
Logout
Figure 5

OPERATOR MANUAL
BIOTECHNOLOGIES
© 08-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
If the operator is a user without administration credentials, the following screen is visible (see Figure 6b).
System Settings
Back
System Settings
Back
Update
Admin
Cartridge
About
Audio
Display
Database
Date & Time
Event Log
Network
Printer
Reports
Figure 6a
System Settings
Back
System Settings
Back
Up
d
at
e
Ad
min
Cartridge
About
Audio
Display
Da
t
abase
Da
t
e
&
T
i
m
e
Event Log
Ne
tw
o
r
k
Printer
R
eport
s
Figure 6b
Settings
By selecting the Settings button, the operator will be presented with one of two settings screens,
depending on whether the operator is an administrator or a user.
If the operator is an administrator, the following screen will appear (Figure 6a).