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Instruction Manual (PN: 5780D00)
Version Date: November 15, 2021

Fluxergy Headquarters Location

FLUXERGY
30 Fairbanks, Suite 110
Irvine, CA 92618, USA

Customer and Technical Support

Attn: Fluxergy Customer Support
30 Fairbanks, Suite 110
Irvine, CA 92618, USA

+1 (949) 305-4201 US & International

Authorized Representative

CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo N° 18, CP 29006
Málaga, Spain

EC REP

CONTACT AND LEGAL INFORMATION

Содержание 5506-CE

Страница 1: ...sional 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 INSTRUCTI...

Страница 2: ...1 Instruction Manual PN 5780D00 Version Date November 15 2021 DISCLAIMER Refer to your respective Instructions for Use IFU for product specific instructions...

Страница 3: ...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...

Страница 4: ...r 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 Disp...

Страница 5: ...nfluence 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 c...

Страница 6: ...5 Instruction Manual PN 5780D00 Version Date November 15 2021 Fluxergy Analyzer SYSTEM OVERVIEW...

Страница 7: ...6 Instruction Manual PN 5780D00 Version Date November 15 2021 Fluxergy Card Fluxergy Analyzer Power Cable Ethernet Cable...

Страница 8: ...ner 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 f...

Страница 9: ...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 cre...

Страница 10: ...ernet 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 d...

Страница 11: ...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 no...

Страница 12: ...e 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 un...

Страница 13: ...evice 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 You...

Страница 14: ...y 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 T...

Страница 15: ...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 Sele...

Страница 16: ...re 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 d...

Страница 17: ...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...

Страница 18: ...e 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...

Страница 19: ...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 o...

Страница 20: ...ide 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 su...

Страница 21: ...will be asked to create a password upon creation of a bak package 01 Navigate to Admin and then History Tab to locate the Backup and Restore buttons Select the Backup button 02 A pop up will appear a...

Страница 22: ...data stored within Fluxergy Works 01 Navigate to Admin and then History Tab to locate the Backup and Restore buttons Select the Restore button 02 A pop up will appear and request you to open the Backu...

Страница 23: ...YYY represents the 4 digit year MM is the two digit month and DD is the two digit day Indicates the unique device identification data Indicates methods to contact customer support Indicates that separ...

Страница 24: ...r 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...