FLUXERGY 5506-CE User manual

5506-CE
For In Vitro Diagnostic Use
For Professional Use Only
IVD
Instruction Manual (PN: 5780D00)
Version Date: November 15, 2021
Fluxergy
30 Fairbanks, Suite 110
Irvine, CA 92618 – USA
[phone]
customersupp[email protected]
www.fluxergy.com
INSTRUCTION MANUAL FOR
THE FLUXERGY ANALYZER SYSTEM
REF

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Instruction Manual (PN: 5780D00)
Version Date: November 15, 2021
DISCLAIMER
* Refer to your respective Instructions for Use (IFU) for product-specific instructions.

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Instruction Manual (PN: 5780D00)
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MAINTAINING A SAFE WORKSPACE........................................................................................................................3
Use of Personal Protective Equipment (PPE) ................................................................................................................................ 3
Disinfection of Laboratory Workspace .......................................................................................................................................... 3
Biohazard Waste Disposal ............................................................................................................................................................. 3
Safety Precautions ........................................................................................................................................................................ 4
SYSTEM OVERVIEW ..................................................................................................................................................5
Fluxergy Analyzer ......................................................................................................................................................................... 5
Fluxergy Card ................................................................................................................................................................................ 6
Fluxergy Analyzer Power Cable ..................................................................................................................................................... 6
Ethernet Cable .............................................................................................................................................................................. 6
Operating Conditions .................................................................................................................................................................... 7
Computer: Recommended Requirements ....................................................................................................................................... 7
Computer: IT Recommendations .................................................................................................................................................... 7
Quick Specs ................................................................................................................................................................................... 7
INSTALLATION AND TROUBLESHOOTING ..............................................................................................................8
Setting up Fluxergy Works Software ............................................................................................................................................. 8
Setup Guidelines ........................................................................................................................................................................... 8
Device Setup: Connecting with a Standalone Network ................................................................................................................... 9
Device Setup: Connecting with Your Local Network ...................................................................................................................... 9
Troubleshooting .......................................................................................................................................................................... 10
Error Codes and Their Meanings ................................................................................................................................................. 10
Restarting a Fluxergy Analyzer ....................................................................................................... Error! Bookmark not defined.
ADDING A DEVICE TO FLUXERGY WORKS............................................................................................................11
MANAGING DEVICES...............................................................................................................................................13
Turning on your Device ............................................................................................................................................................... 13
Checking your Device Availability ............................................................................................................................................... 13
Turning Off or Restarting your Device ........................................................................................................................................ 13
UPDATING FIRMWARE ............................................................................................................................................14
ADDING USERS & USER PERMISSIONS.................................................................................................................16
RUNNING A TEST ON FLUXERGY WORKS.............................................................................................................17
ACCESSING YOUR RESULTS..................................................................................................................................19
BACKUP TEST HISTORY .........................................................................................................................................20
RESTORE TEST HISTORY .......................................................................................................................................21
LABELS AND MARKING ..........................................................................................................................................22
Symbols on Packaging and Analyzer ........................................................................................................................................... 22
CONTACT AND LEGAL INFORMATION ...................................................................................................................23
Fluxergy Headquarters Location ................................................................................................................................................. 23
Customer and Technical Support ................................................................................................................................................ 23
Authorized Representative .......................................................................................................................................................... 23
TABLE OF CONTENTS

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Instruction Manual (PN: 5780D00)
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Use of Personal Protective Equipment (PPE)
Follow your lab’s PPE guidelines. The use of gloves, eye protection, and proper attire are recommended with use of
Fluxergy Analyzer and products.
Disinfection of Laboratory Workspace
The regular disinfection of your laboratory workspace is recommended to reduce risk of contamination. The exterior of
the Fluxergy Analyzer can be gently wiped down with 70% isopropyl alcohol.
Biohazard Waste Disposal
When testing biological samples, it is important to consider the proper disposal of samples. You are responsible for
following the proper biosecurity protocols in your jurisdiction. Use appropriate biohazard refuse containers to dispose
all used test components.
MAINTAINING A SAFE WORKSPACE

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Instruction Manual (PN: 5780D00)
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Safety Precautions
• The Fluxergy Analyzer contains no user-serviceable components. DO NOT disassemble.
• Never attempt to repair or adjust the Analyzer yourself. Unauthorized disassembly and repair could
result in electrical hazards. Only a qualified Fluxergy technician can service the Analyzer. Contact
Fluxergy Customer Support if the Analyzer fails to operate properly.
• Contact Fluxergy Customer Support for any service issues.
• DO NOT stack other equipment or containers on top of the analyzer.
• Keep analyzer away from sources of excessive heat or flames.
• PROTECT your equipment from damp conditions or wet weather.
• DO NOT spill water or other fluids on the analyzer.
• DO NOT use any of the following liquids, abrasives, or aerosol sprays on or near the analyzer, as
they may damage the outer case and may influence test results:
• Organic solvents
• Ammonia-based cleaners
• Sprays containing volatile liquids
• Insecticides
• Disinfectants (Outer case of device can be gently wiped down with 70% isopropyl alcohol if
contaminated)
• Air fresheners
• The Power input supply for the Fluxergy Analyzer is 12VDC, 7A. Be sure to plug all equipment into
properly grounded electrical outlets.
• Use only the power supply provided. Failure to do so may cause damage to the device and/or bodily
harm.
• Disconnect the power cable from the AC power outlet:
• If the power cable becomes frayed, split or otherwise damaged.
• If anything is spilled onto the equipment.
• If your equipment is exposed to excessive moisture.
• If your equipment is dropped or the case has been damaged.
• If you suspect that your analyzer needs service or repair.
• Whenever you clean the case.
• DO NOT use Fluxergy equipment in a manner not approved by Fluxergy.
• Clean the exterior of Analyzer before and after each use to prevent contamination and ensure
trouble-free operation. Use a soft lint-free cloth and 70% isopropyl alcohol solution.

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Instruction Manual (PN: 5780D00)
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Fluxergy Analyzer
SYSTEM OVERVIEW

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Instruction Manual (PN: 5780D00)
Version Date: November 15, 2021
Fluxergy Card
Fluxergy Analyzer Power Cable
Ethernet Cable

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Instruction Manual (PN: 5780D00)
Version Date: November 15, 2021
Operating Conditions
Operating
Storage
Temperature
15°C - 30°C
15°C - 30°C
Relative Humidity
10% – 85%
10% – 85%
Computer: Recommended Requirements
• Operating System
• OS must be 64-bit
• Windows 10 v1151
• Processor: Intel Core i5 2.5GHz or equivalent
• RAM: 8GB DDR4
• HDD: 250GB
• Screen: 1080p
• USB: 2x2.0 port (for scanner and mouse)
• Networking: Ethernet port
Computer: IT Recommendations
Fluxergy recommends regular backups of the PC in which Fluxergy Works is installed. In the case of a PC hardware or
operating system failure, backups will allow restoration of the test history up to the last backup. Without backups, all test
history on the PC will be lost if the PC suffers a non-recoverable hardware or operating system error.
Quick Specs
Fluxergy Analyzer
Fluxergy Card
Length
26.19 cm
1.3 cm
Width
13.13 cm
4.1 cm
Height
25.8 cm
10.8 cm
Weight
6.8 kg
16.8 g (including cap)

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Setting up Fluxergy Works Software
1. Download and install the Fluxergy Works installer.
2. Enter the Registration Key provided to you by Fluxergy.
a.
Note: There is a one-time activation process which requires an internet connection. Work with
your IT department to ensure ports 80 (http) and 443 (https) are open. After activation internet access
is no longer necessary.
3. After installing software, create an administrator account.
a. Note: The administrator account created at this step is the master administrator and cannot be edited
by other administrator accounts.
b. Note: If the master administrative account password is lost, it cannot be reset. To mitigate the risk of
losing all administrative access, Fluxergy recommends creating a secondary administrator account
immediately after install.
4. Information regarding how to run the software can be found in the following sections.
Setup Guidelines
Set up your analyzer on a level surface in a cool dry space. Make sure that the fan in the back of the analyzer will not
be obstructed and that there is enough room for ventilation (at least 6 inches of space around the device).
Next, we will show you two methods of setup: creating an intranet between your device, router, and computer, and
connecting your analyzer to your network.
INSTALLATION AND TROUBLESHOOTING

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Device Setup: Connecting with a Standalone Network
1. Plug in your Analyzer’s power supply to a standard AC outlet. Plug the other end into the DC port found on the
back of the Fluxergy Analyzer.
2. Connect an ethernet cable to the ethernet port found on the back of your Fluxergy Analyzer. Connect the other end
of the ethernet cable to your router via the ethernet port. Do not plug into Internet/WAN port on your router.
3. Connect one ethernet cable to your computer. Plug the other end into one of the ethernet / LAN ports. Do not plug
into Internet/WAN port on your router.
Device Setup: Connecting with Your Local Network
To whitelist each device within your organization’s network, please work with your IT department.
1. Plug in your Analyzer’s power supply to a standard AC outlet. Plug the other end into the DC port found on
the back of the Fluxergy Analyzer. Turn the Analyzer ON using the front power button.
2. Connect an ethernet cable to the
ethernet port found on the back of your Fluxergy Analyzer. Connect the other
end of the ethernet cable to your
local network.
3. Connect your computer to the same subnet as the Fluxergy Analyzer.

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Troubleshooting
Issue
Steps to Take
Fluxergy Analyzer does not power up
a) Check that the power cable to the power supply is connected to an AC
outlet.
b) Check the power cable is plugged into the power supply.
c) Check the DC cable from the power supply is plugged into the
Analyzer.
d) Please contact Fluxergy Customer Support.
Fluxergy Works does not respond or is
frozen.
First change tabs on the sidebar and see if that fixes the issue. If not, exit
out of Fluxergy Works and reopen the program.
Please contact Fluxergy Customer Support for any other software issues.
Any other Issues
Please contact Fluxergy Customer Support.
Error Codes and Their Meanings
Refer to your specific Instructions for Use for test outputs, interpretations, and actions.

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01
Before you connect your device to Fluxergy
Works, please ensure that a network
connection has been established between
the device and your PC. See the installation
and troubleshooting section for more
information.
02
In Fluxergy Works, Click the “Admin” tab on
the left side of the screen.
03
Select the “Device” tab.
04
Choose from the dropdown menu under
“Network Adapter” on the right side of your
screen. Choose the correct network adapter
to scan for available devices. The software
will scan the network for available devices.
ADDING A DEVICE TO FLUXERGY WORKS

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05
Select a device by clicking “Add”. If you wish,
you may alter a device’s name in this window.
Select register.
Note: For better identification of multiple
devices, it is recommended to create a label
with the device name and attach it to the
corresponding device.
06
Your device will now show on the left side of
your screen.
Repeat Steps 5-6 for all analyzers that will be
added to Fluxergy Works.

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Turning on your Device
Turn on the Fluxergy Analyzer by connecting
the power cord to the AC/DC port found on
the back of the analyzer. Press the power
button on the device. The Analyzer can
remain ON when not in use. The Analyzer
must be on to be found by Fluxergy Works.
Checking your Device Availability
Ensure your device is available for testing by
selecting the “Device” tab on the left side of
your screen. The status will show as
“available” when ready to test.
Turning Off or Restarting your Device
Caution: Always power off or restart the
Fluxergy Analyzer from Fluxergy Works.
1. In Fluxergy Works, navigate to the
“Device” tab.
2. Select the Power Button icon for the
Fluxergy Analyzer device.
3. Wait 30 seconds. The front power
indication LED on the device should
power off.
MANAGING DEVICES

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The following instructions are for updating the firmware of your Fluxergy Analyzer via Fluxergy Works. You will be
notified by Fluxergy when an updated Firmware is available for download.
01
In Fluxergy Works, Click the “Admin”
tab on the left side of the screen.
02
Select the “ Firmware” tab.
03
Select the Firmware Source dropdown,
and pick “LOCAL”.
Select the “Check for Updates” button.
UPDATING FIRMWARE

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04
Navigate to the patch file and select it.
05
Select the update icon:
A dialogue window will pop-up briefly and
then firmware installation will
automatically begin. If an error message
appears, please restart Fluxergy Works
and try again.
06
Wait approximately 5 minutes. Device will show as “unavailable” during this time.
Once device is “available” again, then you can use the system.
If you receive an error message immediately, or if the device is still “unavailable” after 10 minutes, contact
Fluxergy Customer Support.

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01
In Fluxergy Works, Click the “Admin” tab on
the left side of the screen. In the “User” tab,
select “Add New User”.
02
Add your new user’s name, email, user ID,
and password. Choose the level of
functionality you want for the new user.
Administrator users have the following
capabilities: adding devices, removing
devices, adding users, removing users,
viewing device statuses, editing user
information, running tests, and viewing test
results.
User privileges are dependent on user type.
Administrator users can assign user types
that have restricted functionality within
Fluxergy Works.
03
Select “Add”. Your new user will display and can log in using their user ID and password.
ADDING USERS & USER PERMISSIONS

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Instruction Manual (PN: 5780D00)
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01
Open Fluxergy Works and log in using
your user ID and password.
02
Click the “Run Test” tab on the sidebar on
the left side of your screen.
03
Scan the barcode on the Individual Fluxergy
Card Package.
Note: For best results, ensure that the
scanning surface is flat, and entire barcode
can be captured.
04
If the barcode cannot be scanned a prompt will
appear, “Scanner or barcode invalid, please
enter card serial number manually.” Click OK
and enter card serial number or scan again.
RUNNING A TEST ON FLUXERGY WORKS

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05
Add a test name and sample ID. Every test
name must be unique.
06
Click run test in the bottom right corner.
Select your connected analyzer and click run
test. Insert the Fluxergy Test Card into the
device.
Once inserted, press “OK”. The analyzer will
begin the assay once test card has been
inserted.
Caution: Refer to Instructions for Use for
specific instructions in setting up and
running test!

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Access Tests in Dashboard
Once you select “OK” to run the test, you will be
redirected to the dashboard. Here, you can find tests
in progress as well as a list of your most recent tests.
Access Tests in History
To see all tests, select the “History” tab.
On the right-hand side of the page, you can choose
to delete, export,
print, or view results for each test.
Manage Tests
Selecting the trash icon will delete test data permanently.
Selecting the file icon will display test summary.
Selecting the printer icon will enable you to print test
summaries.
Select the far-right option, the magnification glass and
graph icon, to view your results. From this screen, you
may export test data.
Navigating to Qualitative Results
Select Summary D to see a simplified
summary and qualitative result.
ACCESSING YOUR RESULTS