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INSTRUCTION MANUAL FOR
THE FLUXERGY ANALYZER SYSTEM
5506-CE
REF
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
(949) 305-4201
customersupport@fluxergy.com
www.fluxergy.com
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Table of Contents
Troubleshooting
Summary of Contents for FLUXERGY 5506-CE
- Page 1 INSTRUCTION MANUAL FOR THE FLUXERGY ANALYZER SYSTEM 5506-CE For In Vitro Diagnostic Use For Professional Use Only Fluxergy 30 Fairbanks, Suite 110 Irvine, CA 92618 – USA (949) 305-4201 Instruction Manual (PN: 5780D00) customersupport@fluxergy.com Version Date: November 15, 2021 www.fluxergy.com...
- Page 2 DISCLAIMER * Refer to your respective Instructions for Use (IFU) for product-specific instructions. Instruction Manual (PN: 5780D00) Version Date: November 15, 2021...
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Page 3: Table Of Contents
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 ................................ -
Page 4: Maintaining A Safe Workspace
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. -
Page 5: Safety Precautions
• 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. -
Page 6: System Overview
SYSTEM OVERVIEW Fluxergy Analyzer Instruction Manual (PN: 5780D00) Version Date: November 15, 2021... -
Page 7: Fluxergy Card
Fluxergy Card Fluxergy Analyzer Power Cable Ethernet Cable Instruction Manual (PN: 5780D00) Version Date: November 15, 2021... -
Page 8: Operating Conditions
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. -
Page 9: Installation And Troubleshooting
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. Information regarding how to run the software can be found in the following sections. -
Page 10: Device Setup: Connecting With A Standalone Network
Fluxergy Analyzer. 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. -
Page 11: Troubleshooting
First change tabs on the sidebar and see if that fixes the issue. If not, exit frozen. 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. -
Page 12: Adding A Device To Fluxergy Works
PC. See the installation and troubleshooting section for more information. In Fluxergy Works, Click the “Admin” tab on the left side of the screen. Select the “Device” tab. Choose from the dropdown menu under “Network Adapter”... - Page 13 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. Instruction Manual (PN: 5780D00) Version Date: November 15, 2021...
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Page 14: Managing Devices
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”... -
Page 15: Updating Firmware
UPDATING FIRMWARE 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. In Fluxergy Works, Click the “Admin” tab on the left side of the screen. - Page 16 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. Wait approximately 5 minutes. Device will show as “unavailable” during this time. Once device is “available” again, then you can use the system.
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Page 17: Adding Users & User Permissions
ADDING USERS & USER PERMISSIONS In Fluxergy Works, Click the “Admin” tab on the left side of the screen. In the “User” tab, select “Add New User”. Add your new user’s name, email, user ID, and password. Choose the level of functionality you want for the new user. -
Page 18: Running A Test On Fluxergy Works
RUNNING A TEST ON FLUXERGY WORKS Open Fluxergy Works and log in using your user ID and password. Click the “Run Test” tab on the sidebar on the left side of your screen. Scan the barcode on the Individual Fluxergy Card Package. - Page 19 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.
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Page 20: Accessing Your Results
ACCESSING YOUR RESULTS 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”... -
Page 21: Backup Test History
A pop-up will appear and request you to select where to save your backup (.bak) package file. Chose a folder on your computer to save the .bak package. Fluxergy Works will prompt you to create a password for the backup (.bak) package. Note: Passwords cannot be retrieved if lost. -
Page 22: Restore Test History
“Imported” tab within the “History” page. Warning: Restoring of test history by loading a .bak file erases and replaces all current test data stored within Fluxergy Works. Navigate to “Admin” and then “History” Tab to locate the Backup and Restore buttons. -
Page 23: Labels And Marking
(WEEE) is required. Indicates the Fluxergy catalogue number so that the medical device can be identified. Indicates the Fluxergy serial number so that a specific medical device can be identified. Indicates the medical device manufacturer, as defined in EU Directive 98/79/EC. -
Page 24: Contact And Legal Information
Fluxergy Headquarters Location FLUXERGY 30 Fairbanks, Suite 110 Irvine, CA 92618, USA Customer and Technical Support Contact us by Mail Attn: Fluxergy Customer Support 30 Fairbanks, Suite 110 Irvine, CA 92618, USA Contact us by Email customersupport@fluxergy.com Contact us by Phone +1 (949) 305-4201 US &...