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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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
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© 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

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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).

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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).
The Audio screen permits the user to adjust the tone volume at the completion of each cartridge that is run
(see Figure 8).
System Settings
Back
Database
Date & Time
Event Log
Network
Printer
Reports
About
Audio
Display
Update
OK
VERSIONS
NETWORK
Atmel 10.3 B 99999 +e299c4
About
Logic 4.16
RF
Ethernet IP Address 192.168.0.3
Wi-Fi IP Address 192.168.1.56
Up Time
Measurement
Cartridges4.14
6,004 hours
88 hours
620
Serial Number 2006X022
TOTALS
Figure 7
System Settings
Back
About
Audio
Display
Database
Date & Time
Event Log
Network
Printer
Reports
Update
System Sett
i
ng
s
Back
Ab
out
A
ud
i
o
Disp
l
ay
Data
b
as
e
Date & Time
Date & Time
E
vent Lo
g
Networ
k
P
r
i
nt
er
Reports
Up
d
at
e
Audio
OK
Mute
OK
Figure 8

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The backlight of the display can be adjusted through the Display option (see Figure 9).
The Event Log screen (Figure 10) permits the user to view and download internal information about instrument
operation. This may be useful for customer support cases.
System Settings
Back
About
Audio
Display
Database
Date & Time
Event Log
Network
Printer
Reports
Update
System Sett
i
ng
s
Back
Ab
out
A
ud
i
o
Disp
l
ay
Data
b
as
e
Date & Time
Date & Time
E
vent Lo
g
Networ
k
P
r
i
nt
er
Reports
Up
d
at
e
Display
Backlight
OK
Figure 9
Back
Back
Event Log
OK
Download
Jul 20 14:22:28 RDXI local1.notice veyron: 40 EventLog
Jul 20 14:22:27 RDXI local1.notice veyron: 40 SetupMenu
Jul 20 14:22:11 RDXI local1.notice veyron: 40 Diagnostics
Jul 20 14:22:00 RDXI local1.notice veyron: 40 SetupMenu
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
Last 50 entries in Event Log
Figure 10

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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.
The user can print a test page after setting up the printer (Figure 12).
System Settings
18:30Monday 4/13/2020
System Settings
Back
Back
Database
Date & Time
Event Log
Network
Printer
Reports
About
Audio
Display
Database
Date & Time
Event Log
Network
Printer
Reports
Update
Printer Setup
Auto-Print Results
On Off
Print Test Page
OK
Figure 11
Back
IgG Result:
Positive 1.1 AU/mL
Printing Test Page
Printing...
Cancel
Figure 12

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The Cartridge screen (Figure 13) allows the user to insert a cartridge and read its test type, lot code, and status. In
this way, the user may determine if a cartridge has already been used, without going through the process of setting
up a new test.
Settings screens for users with administrator privileges
Several other items in the Settings screen permit an operator with administrator credentials to perform certain
restricted functions.
The Database screen (Figure 14) enables test results to be automatically uploaded to the database immediately
after the test finishes. Check the “Auto-Send After Measurement” to enable this feature.
Back
Cartridge Data
Lot Code
Serial Number Status Unused1
10008 Test Name SARS-CoV-2 Ag
OKPrintEject
Figure 13
Back
SendDiags to USBResults to USB
OK
Auto-Send After Measurement
DATA FORWARDING
None
Figure 14

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The Date and Time screen allows the user to set the current date and time (see Figure 15).
The Reports button brings up the Configure Report screen that enables the user to select the items to be included in
the printed report (see Figure 16).
System Settings
System Settings
Back
Back
About
Audio
Display
Update
Database
Date & Time
Event Log
Network
Printer
Reports
Date & Time
Jul 20 2021 14 22
PM
Cancel
24-Hour
Time Zone
America/Chicago
OK
:
AM Auto
Figure 15
System Settings
System Settings
Back
Back
Database
Date & Time
Event Log
Network
Printer
Reports
About
Audio
Display
Database
Date & Time
Event Log
Network
Printer
Reports
Update
Patient Name
Date of Birth
Identifier
Clinician
Sample Source
Select items to include. Configuration will persist.
Result
Date and Time
Instrument S/N
Cartridge Lot#
Gender OK
Figure 16

OPERATOR MANUAL
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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).
From the Settings/Network panel, you may press “Wi-Fi” to bring up the Wi-Fi configuration panel (Figure 17a). From
this panel you may turn the Wi-Fi on or o. When the Wi-Fi is turned on, you will see a list of available networks and
you may select a network for connection. Touch one of the displayed networks and enter the login password for that
network (Figure 17b). The Omnia system permits connections only to WPA2-PSK (Personal) networks.
Back
Network
Network Status: Internet Access
Ethernet IP: 192.168.0.3 Wi-Fi IP: 192.168.1.56
Network Settings
Wi-Fi IP Settings OK
Figure 17
Figure 17a
Update
Database
Date & Time
Event Log
Network
Printer
Reports
Up
d
at
e
Data
b
as
e
Date & Time
Date & Time
E
vent
L
o
g
Networ
k
P
r
i
nte
r
R
eports
Wi-Fi
OKRefresh
WPA2 NETWORKS
TOP NOTCH WiFi
TOP NOTCH-Guest
ATT-WiFi-ejpE
DIRECT-2730E6B6
Selected Network: ATT-WIFI-ejpE
Wi-Fi
On Off

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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. Automatic mode is recommended and is set by default. You may change the
mode to manual by pressing the “O” button labeled “Automatic IP”. Once in manual mode, you may enter the IP
configuration settings in the “Static IP Configuration” control fields on the left side of the panel.
Figure 18
Back
IP Settings
Automatic IP
On Off
OK
Static IP Configuration
IP Address
Subnet Mask
Default Gateway
Figure 17b
Update
Database
Date & Time
Event Log
Network
Printer
Reports
Wi-Fi
Selected Network: ATT-WIFI-ejpE
Password*

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The Admin button will bring up the Admin screen (Figure 20), permitting an operator with administrator credentials
to add or remove users.
Back
Back
Update
About
Audio
Display
Database
Date & Time
Event Log
Network
Printer
Reports
Back
Back
Back
Back
Admin
OK
User ID
admi
n
d
emo
User Type
A
dministrator
L
ab Tec
h
User Name
I
nitial Admin Account
D
emo
U
ser
Add E
d
it
Dele
t
e
Figure 20
Back
B
ac
k
Software Update
Insert a Software Update USB Flash Drive into a USB Port
Cancel
Figure 19
The Update button brings up the Software Update screen (Figure 19) that enables updates of the system software by
those with administrator privileges.

BIOTECHNOLOGIES
OPERATOR MANUAL
Update
About
Audio
Display
Database
Date & Time
Event Log
Network
Printer
Reports
Add/Edit User
O
KCancel
User ID
ID
User Type
Password
Use
r
’s
P
ass
w
o
r
d
User Name
F
i
rst Name
,
Last Name
C
hoose User Type
Figure 21
The following image (Figure 22) shows an example after entering the user information.
Update
About
Audio
Display
Database
Date & Time
Event Log
Network
Printer
Reports
Add/Edit User
O
KCancel
User ID
JD
o
e
User Type
Password
Q
WERTY
User Name
Joh
n D
oe
L
ab
T
ech
Figure 22
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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.

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Back
Back
Update
About
Audio
Display
Database
Date & Time
Event Log
Network
Printer
Reports
Back
Back
BackBack
Admin
OK
User ID
admi
n
d
emo
JDoe
User Type
A
dministrator
L
ab Tec
h
Lab
T
ec
h
User Name
I
nitial Admin Account
D
emo
U
ser
Jo
hn D
oe
Add E
d
it
Dele
t
e
Figure 23
After the user information is entered, press the OK button. The interface will return to the Admin screen (Figure 23)
and the new user and user type will appear.
This concludes the description of items selectable from the Settings screen.