QFX Fluorometer
User Guide

Version: 9-MAY-2024
1

Table of Contents
1.

Introduction --------------------------------------------------------------------------------------------------- 4

Product Technology............................................................................................... 4
Upgrade Options ................................................................................................... 4
2.

Set up and Safety -------------------------------------------------------------------------------------------- 5
Cautions ................................................................................................................ 5
Instrument Rear Panel........................................................................................... 5
VCCI (Class B) compliance statement for users in Japan..................................... 6

3.

Instrument Diagram ---------------------------------------------------------------------------------------- 7

4.

Software Quick Guides ------------------------------------------------------------------------------------ 8
EasyApps

Software Icons .................................................................................. 8

Software Buttons ................................................................................................... 9
Software Navigation .............................................................................................. 9
Top Bar Overflow Functions ................................................................................ 10
5.

Tech Team Tips -------------------------------------------------------------------------------------------- 11
Connectivity and Results Data ............................................................................ 11

Software Updates ................................................................................................ 11
Technical Support................................................................................................ 11
6.

Fluorescence: Basic Operation ----------------------------------------------------------------------- 12
Fluorescence Measurements .............................................................................. 12Best Practices...................................................................................................... 12

7.

Fluorescence: Standard Curve Method Apps --------------------------------------------------- 14
Quick Protocol ..................................................................................................... 14
Run Screen- Assay and Curve Selections .......................................................... 16
Run Screen- Standard Curve View ..................................................................... 17

8.

Basic Fluorometer App ---------------------------------------------------------------------------------- 20
Quick Protocol ..................................................................................................... 20
Excitation Selection and Emission Results.......................................................... 20

9.

Data Export and Print Options ------------------------------------------------------------------------ 22
Export Options ..................................................................................................... 22

Export Via Email .................................................................................................. 22
Export to a Network Folder .................................................................................. 23
USB ..................................................................................................................... 23
Print Options ........................................................................................................ 23
10.

Utility Apps and Functions ---------------------------------------------------------------------------- 24
User Accounts App .............................................................................................. 24
Data App.............................................................................................................. 26
Exporting and Deleting Data................................................................................ 26
Settings App ........................................................................................................ 27

Updater App ........................................................................................................ 30
211. 21 CFR App 31
Compliance Ready Software ............................................................................... 31
Activation Wizard Overview ................................................................................. 32
Activation Wizard 1/7 - Administrator Account .................................................... 32

Activation Wizard 2/7 – Enter Activation Code .................................................... 32
Activation Wizard 3/7 - Roles .............................................................................. 32
Activation Wizard 4/7 – Signature Meaning......................................................... 33
Activation Wizard 5/7 – Role-Signature Meaning Linking.................................... 33
Activation Wizard 6/7 – Password Rules ............................................................. 34

Activation Wizard 7/7 – Existing Users ................................................................ 34
Measurements and Electronic Signed Records .................................................. 35
Audit Trail ............................................................................................................ 36
Archiving .............................................................................................................. 37
12.

21 CFR Mode - Utility Apps and Functions ------------------------------------------------------ 38
User Accounts App .............................................................................................. 38
Data App.............................................................................................................. 40
Settings App ........................................................................................................ 41
Updater App ........................................................................................................ 41

13. Lab Tool Apps ---------------------------------------------------------------------------------------------- 42
Calculator App ..................................................................................................... 42
Timer App ............................................................................................................ 43
ScreenLocker ...................................................................................................... 43
14. Maintenance------------------------------------------------------------------------------------------------- 44

Guidelines............................................................................................................ 44
Fluorescence Mode Holder Cleaning .................................................................. 44
15. Diagnostics -------------------------------------------------------------------------------------------------- 45
FX Diagnostics .................................................................................................... 45
16. Troubleshooting ------------------------------------------------------------------------------------------- 46
Fluorescence Mode ............................................................................................. 46
Software Errors.................................................................................................... 46
Printer and Barcode Scanner .............................................................................. 46
17. Customer Support ---------------------------------------------------------------------------------------- 47

Warranty .............................................................................................................. 47
Disclaimer ............................................................................................................ 47
Instructions for Disposal of Packaging and Waste Equipment ............................ 47
Research Use Only ............................................................................................. 47

3

1. Introduction
Product Technology
DeNovix QFX Fluorometers are compact, stand-alone instruments with a high-resolution
touchscreen. EasyApps software utilizes application specific icons along with a custom
operating system to provide an intuitive, easy-to-use instrument for fluorescencemeasurements.

Key Features• Stand-Alone Design, no-PC Required• Hi-Definition 7-inch Touchscreen Interface• Simple, Intuitive EasyApps Software• Four LED Excitation Options• Wi-Fi, Ethernet and USB connectivity

Upgrade Options•

Activate 21 CFR Part 11 Compliance Ready Software.

42. Set up and Safety
1. Remove all packing materials.

2. Plug the unit into a 100-240 VAC, 50-60/Hz receptacle using the grounded power
supply (Globtek part number TR9CE3000C95CP-NR6B / RoHS Compliant) included witheach unit. Input Rating: 100-240V~, 50-60 Hz, IEC 60320/C14 , Output Rating: 36W,
12V@3A
3. Turn on the power switch located in the back of the instrument. The operating system
will boot up in less than a minute.
4. Turn off the power switch to shut down the instrument.

Cautions
DO NOT REMOVE COVER
No operator serviceable components inside. Refer servicing to qualified
personnel.
The DS-11 Series is designed for indoor use under the following conditions:Temperature: 15˚ to 35˚ C
Humidity:
35 to 65 %Elevation:
2000m or less
Pollution:
Pollution degree 2
Use only the power supply provided with the instrument. Use of the
instrument in any manner not specified by the manufacturer may impair theprotection provided by the supplied power cord and power supply.

NE PAS OUVRIR L’APPAREIL.
Aucun composant réparable par un utilisateur est inclus. Confiez l'entretien à dupersonnel qualifié .
Le DS- 11 est conçu pour une utilisation en intérieur dans les conditions suivantes :Température : 15° à 35˚C
Humidité: ........35 à 65%
Utilisez uniquement le bloc d'alimentation inclus avec l'instrument. Utiliser l’appareil dansdes conditions non spécifiées par le fabricant peut compromettre la protection offerte
par le cable d’alimentation et le bloc d'alimentation fournis avec l’appareil.

Instrument Rear Panel
The QFX comes equipped with Wi-Fi, Ethernet and three USB ports. The USB ports areused to facilitate data transfer to a FAT32 formatted USB storage device and connect tothe accessory FX Module. In addition, the USB ports support the use of select label
printers* and an Opticon OPI 3601 USB barcode reader. USB mouse and keyboard devices
may also be used with the QFX Fluorometer.
*

Please refer to our website for a list of supported label printers.
5

VCCI (Class B) compliance statement for users in Japan
This is a Class B product based on the standard of the Voluntary Control Council forInterference (VCCI) from Information Technology Equipment. If this is used near a radioor television receiver in a domestic environment, it may cause radio interference. Installand use the equipment according to the instruction manual.
This equipment has been tested for radio frequency emissions and has been verified tomeet CISPR 22.2 Class B.

6

3. Instrument Diagram7

4. Software Quick Guides
EasyApps Software Icons

Home

Add

Select All

Overflow
Menu

Edit

ExportClear
Selected

Copy

DeleteInformation

Progress bars or busy indicators are used to indicate the instrument
is in the process of making a measurement. Please wait until theicon has disappeared before performing additional actions.

The Quick Print icon is only displayed on Report or Graph screens
when a label printer is connected to the instrument.
Auto Export status icons are displayed at the top right of a Run
screen. Ensure Wi-Fi is connected prior to making a measurement.

8

Software Buttons
Software Navigation

The fluorescence apps Standards Measure button is used tomeasure standards when building a standard curve.
The Samples Measure button is used to quantitate samples.
The fluorescence apps Replicates On/Off button is used to define if
the standards curve enables one or up to three replicates.
The fluorescence apps Basic Measure button is used to make single
measurements not being read from a standard curve.
Fields with Drop-Down Menus are indicated by black or white
triangles located on the center bottom.
Fields with black underlines are editable by the user. Tapping on thefield will enable a keyboard, a numeric keypad or a dialog box.
Application specific editor options can be accessed using the List
Add/Edit button found to the right of some drop-down menus.

Options buttons are used for such purposes as change
units or trend line analysis parameters in the
fluorescence apps.
An accept and return to previous screen button is found in the lower
right of some screens. All changes made to a selection are
immediate.

Apps are launched using Home screen icons. Swipe the Home pageto the left for additional icons.
The app Run, Report and Graph screens are accessed either by thetabs on the top bar or by swiping the screens left or right.

Use the Account Tab drop-down menu on the top action bar in theRun, Report and Graph screens to select a specific account within
an app. Use the Accounts app to create and manage accounts.

9

Top Bar Overflow Functions

ScreenCaptureA .png may be exported as described in the chapter entitled"Screen Capture and Export" using this option.

ChangeUnits

Concentration units may be changed in some apps using thisoption.

Clear
SamplesThis function saves and then clears all current sample records
from the Report and Graph screens.

User Guide

The User Guide may be accessed either from the Overflow icon
within any app or by launching the User Guide app.

About

The About feature brings up an information box displaying thecurrent app version number.

Lamp Reset

The Diagnostics app Lamp Reset is used as a means to reoptimize a lamp when necessary.

Tech Support

The Diagnostics app Tech Support feature is used to send
instrument related diagnostics files to DeNovix customer
support.

Exit

Use the Exit function to close an application.

10

5. Tech Team Tips
Connectivity and Results Data
• Use the Settings App to configure Wi-Fi or connect an ethernet cable to the rear
ethernet port on the instrument.
• Within Settings configure email, network printers and network folders.
• Compatible label printer models enable immediate printing of results.
• Use the share icon

to export results to USB or one of the connected methods above.

• All results are saved on the device until deleted. Export during a measurement session
or use the Data App to search for and export results later.
• For ease-of-use, an open access default General account is active when apps are
opened. Use the User Accounts app to set up other accounts, password protect them if
desired and configure app specific launch defaults as desired.
• Although there is no harm in doing so, there is no need to shut down the instrument
each day. The backlight for the screen will automatically turn off to protect the screen
and will switch on when touched.

Software Updates• Connect to the Internet and open the Updater App. Check for updates and download
directly to the device. Alternatively, visit our website to download the update package
to a FAT32 formatted USB drive. Insert the USB drive and then launch Updater.

Technical Support
Visit our website for instructional videos, Technical Notes and for troubleshooting tips.
Contact your DeNovix Distributor or email info@denovix.com for help.

11

6. Fluorescence: Basic Operation
DeNovix Fluorometer software includes fluorescence EasyApps software. The
fluorescence app icons will appear on the Home screen.
Activation of 21 CFR Part 11 Compliance Ready Software affects some aspects of theuser interface. Where applicable additional instructions for 21 CFR Mode operation areprovided. Contact DeNovix or your local Distributor to purchase an activation code.
The table below lists the four LEDs included in the QFX. Users must select theappropriate LED for the assay that they choose for quantification.

LEDs

Excitation Filter Range

Emission Filter Range

UV361 - 389 nm

435 - 485 nm

Blue

442 - 497 nm

514 - 567 nm

Green490 - 558 nm

565 - 650 nm

Red

613 - 662 nm

664 - 740 nm

Fluorescence Measurements•

Insert a PCR tube pre-filled with the fluorescent solution. Close the cover and tap
Measure.
Notes:•

Use clear thin-walled 0.5 mL plastic PCR tubes only•

Measure 200 µL volume samples.

Best Practices• Ensure all sample concentrations in the thin-walled assay tubes fall within the limits of
the assay or reagent kit for accurate results.
• Use 200 μL volumes in a clear thin-walled PCR tube.
• Lower the cover before tapping the measure button.
• Avoid introducing air bubbles into the sample solution when mixing samples.
• Follow assay reagent manufacturers' recommendations regarding temperature,incubation time, and protection from ambient light.
• Follow assay reagent manufacturers' recommendations regarding suggested standard
curve concentrations and data analysis.
12• Ensure all samples and standards are treated identically in terms of incubation times
and temperature.
• Minimize assay tube and solution temperature fluctuations as these may impact theaccuracy of the assay. Samples at higher temperatures will generally have lower
fluorescence.
• Do not label the side of an assay tube as this could interfere with the sample
measurement.

13

7. Fluorescence: Standard Curve Method Apps
The EasyApps listed below are designed using the same basic architecture. Each app
includes a choice of four excitation LEDs (UV, Blue, Red, Green) and a variety of assays.
The end user is responsible for selecting the proper choice based on the analyte that will
be used for quantification.

FluorodsDNA•DeNovix dsDNA Broad Range•DeNovix dsDNA High Sensitivity•DeNovix dsDNA Ultra High Sensitivity•Quant-iT

PicoGreen
dsDNA HS
•Quant-iT dsDNA BR•Quant-iT•DeNovix RNA Assay

FluoroRNA

FluorossDNA

FluoroProtein•Quant-iT

RiboGreen•Quant-iT RNA HS•Quant-iT RNA BR•Qubit RNA HS•QubitdsDNA BR
dsDNA HS
•Quantifluor dsDNA•Quantifluor One dsDNA•Qubit 1X dsDNA HS•Qubit 1X dsDNA BR•Qubit•QubitRNA BR•Quantifluor RNA•Quant-iT•QubitmicroRNA
microRNA•Quant-iT

OliGreen
ssDNA•Quantifluor ssDNA•Qubit•Quant-iT

ProteinProtein•Qubit Protein BR•QubitFluoro•All entries to be defined by the user
Std Assays

Quick Protocol
1. Launch the app from the Home screen.
2. Select an excitation LED using the drop-down menu on the Run screen.

3. Generate a new curve:•

Insert the standard (200 μL total assay volume in a thin-walled PCR tube) into thesample holder and lower the cover. Measure at least one replicate for a minimumof 2 standard concentrations.
14

•

Alternatively, import a saved curve or list of sample concentrations

4. Tap the Samples radio button.
• Optional: Enter a sample name and a dilution factor to be applied to the reported
concentration.
5. Quantitate a sample using the Measure button.

Refer to the manufacturer of the assay reagent for assay specific instructions.

Note:
•

DeNovix and Qubit

assays will have predefined standard concentrations and specified units.

15

Run Screen- Assay and Curve Selections

Excitation Source (LED) and Assay Selection• Select the LED from the drop-down menu in the left panel. The user must choose theappropriate LED for the analyte in use.
• New assays may be entered using the List Add/Edit button.
• User defined assays may be used by all accounts but may be modified or deleted onlyby the account owner.

Curve Options
Generate New Curve• Choosing this option will pop-up a dialog window used to enter the concentration
values for the standards.
• Verify the concentrations of the standards for the LED / Assay chosen. The standard
concentrations for all other assays are determined by the user at the time of the assay• Trend line analysis options and concentration units used may be changed using theadvanced options button.
• Blank: If selected, the first row in the standards table is used to measure a Blank.
The average RFU value of the blank measurements will be subtracted from all
standard and sample measurements. If the Blank is not selected, the initialconcentration for preconfigured assays will be set to 0.00. This standard istypically the reagent/fluorophore solution without any nucleic acid or protein.

• Trend Line: If selected, the trend line will be forced through the lowest standard
concentration. When a Blank is used, the trend line will be forced through the graphorigin (0,0).

16

Use Previous Curve or Std Values• Choosing this option will pop-up a dialog window with a radio button selector for saved
standard curves and saved standard curve concentration lists.
• All modifications to a curve or list are effective immediately. It is important to save theselection with a new name prior to making any changes if you do not want to modify
the original curve or standards list. Changes to a curve do not affect previously
measured samples.
• Although all saved lists and saved curves are available for use by all accounts, only theaccount holder may modify the selection.

Run Screen- Standard Curve View

• The Stds button will pop-up the Edit Concentrations for Standard Curve window.
• The Delete and Undo icons are used to manage the RFU values within the table.
• The Save button will pop-up the Save Values window. Either concentration values orconcentration values with the associated RFU values may be saved.

• The New Curve button is used to generate a new curve or load a previously saved
curve. All sample data generated using the Samples radio button will be automaticallysaved and accessible using the Data app.
• The Replicates arrow button enables the use of up to three replicate measurements
per standard concentration. The average of the replicates will be used to generate thetrend line.

17

Run Screen- Sample Results View

• Use the Samples radio button to display the measurement results view.
• The samples Measure button will be disabled until one replicate of at least two
standards are measured using the standard curve view.
• The Concentration from Curve results are calculated directly from the standard curve
trend line. Results are reported in terms of the units used to derive the trend line.
• The Optional Dilution Factor (or the µL Added value for Qubit assays) will be applied
as a multiplier to the Concentration from Curve value and the result reported in the
Sample Stock Concentration field.

• The Sample Stock Concentration results are reported in terms of the units selected by
the user. The value saved in Report will be displayed in terms of the units in use at thetime of the measurement.

New Standard Curve Assays/Methods
Each new method requires a unique name. In addition, the following parameters must be
defined:Excitation Source• Use LED Radio buttons to select the excitation source.
• The LED Wizard may be used to determine a compatible excitation source if not
known. The software will make a measurement using each of the four excitation
sources and will report the associated RFU in the color-coded boxes.
• Some fluorophores do not exhibit significant fluorescence unless bound to aprotein or nucleic acid. It may be necessary to set up an assay reaction to best use
the LED Wizard.
• The standard curve assay methods use one excitation source to determine theconcentration of a sample based upon the RFU measured using the corresponding
emission filter set.
18

Advanced Options• Use the Advanced Option buttons to set both the Trend Line/Blank selections aswell as the standard curve units.

Although all accounts may use any saved method, only the method account holder or an
administrator may modify or delete the new method.

19

8. Basic Fluorometer App
Basic Fluorometer

This app enables DeNovix systems to be used as a versatile fluorometer for applications
such as dye QC checks and assay development. The app is especially useful for
fluorophores with significant Stoke shifts as it allows the user to excite a sample with
one LED and obtain RFU results from multiple emission channels.

Quick Protocol
1. Launch the app from the Home screen.
2. Select an excitation LED using the radio buttons.
3. Optional: Create and Save a used defined method (LED selection and user defined
assay name).
4. Optional: Enter a sample name.

5. Tap the Measure button.

Excitation Selection and Emission Results• Select an excitation source (LED) or LED plus fluorophore combination.
• The selected LED is the only excitation source used during a measurement. However,
the emission RFU will be collected for each longer wavelength emission filter set.
• For example, if the blue LED is selected, the emission results for the blue, green
and red channels will be reported. If the green LED is selected, only the green andred channel results will be reported.
20• User defined fluorophores may be entered using the List Add/Edit button.
• The Add button will pop-up a window that includes a LED Wizard. Tapping the
Wizard button will result in the sample being excited by each LED and the RFU
measured by the corresponding detector. The user can select the LED mostcompatible with the method.

21

9. Data Export and Print Options
Export Options
From the Report screen, sample data may be exported via email, to network printers,
network folders or saved to a FAT32 formatted USB flash drive. Export options varydepending on the destination. For instance, the full contents of a csv file cannot be sent
to a network printer.

Export Formats
CSV file• The default .csv file format for each absorbance measurement app includes all
absorbance vs wavelength data for the app specific measurement wavelength range
as well as the calculated data displayed on the app Report screen. The csv file can besaved to USB, saved to a network folder or emailed.
• To open an exported .csv file on a computer, the DeNovix instrument and the computer
must both be set to use either period or comma number formats. The instrument’s
number format is determined by the language selected in the Settings app.
PDF Report• A pdf report file can be generated for each measurement app. The pdf can be saved toUSB, emailed, printed to a network printer or saved to a network folder.

Screenshots• Use the overflow menu to capture the active screen. This is a convenient way to export
graphs from the Graphs page. The png file may be exported by email, saved to a
network folder, saved to a USB drive or printed to a network printer.

Export Via Email• Screen captures, .csv files and pdf summary reports may be exported via email.
• Use the User Accounts app Address Book to save frequently used email addresses.
• It is recommended that a new, dedicated POP3 Gmail or Outlook account be used forall outgoing email from the QFX. This type of account works very well with the
instrument's operating system and prevents personal incoming email from being
stored on the unit.

22

Export to a Network Folder
The instrument can export to SMB network folders connected to the same network as the
instrument. For best results connect to the network through an ethernet connection,
especially if exporting pdfs and images. See Settings App section for more information.

USB• Screen captures, pdf reports and data .csv files may be saved to a FAT32 formatted
USB flash drive.

• There are two USB ports on the back of the instrument and one on the side although
only one storage device is recognized at a time. The two additional ports may be used
for the FX Module accessory, label printers, keyboards, mouse and barcode readers.
• DO NOT USE INSTRUMENT USB PORTS TO CHARGE OTHER DEVICES.
• DO NOT CONNECT MOBILE PHONES TO USB PORTS.

Print Options• The QFX can print to networked printers or to select label printers. Label print-outs arein black and white. See our website for a list of supported label printers and supported
label sizes.

Network Printers• Screenshots and pdf summary reports may be printed to network printers.
• Use the Settings app to search for and add printers. Printers that are configured as
driverless CUPS printing are supported.
• Please contact DeNovix or your local distributor for a list of recommended printers if
your current printer is not recognized on the network.

2310. Utility Apps and Functions

User
Accounts

Data

Settings

UpdaterStandard Mode Instructions
This section describes functionality for instruments that are not running in 21 CFR Mode.
Please see the 21 CFR Utility Apps and Functions section for details about how the apps
are configured in that mode.

User Accounts App
The User Accounts app allows users to create and manage individual accounts. Users
can adjust their default settings. Accounts are also used as a means of segregating datawhen performing searches in the Data app.

App Structure
Accounts are listed in the left pane of the screen. A menu of app function options ispresented in the action bar, where the selected option is highlighted with a blue
background.
Select a user account from the dropdown list in the top grey bar and select an option to
edit: Profile, Report Emails, File Share, and Defaults.

App Functions
The basic functions controlled using the Account app are as follows:•

Adding and deleting accounts•

Managing passwords for accounts•

Managing email addresses associated with an account•

Setting account specific app protocol preferences

Default System Accounts
There are two preconfigured system accounts built into the software - the General
Account and the Primary Administrator Account. These accounts may not be deleted.

Primary Administrator•

This account is used to manage instrument settings. It is not used within themeasurement applications.

•

The primary administrator account is not initially password protected. A password
may be applied at any time.
24General Account•This account is used as the default selection for all apps each time an app is opened.
This account may not be password protected or deleted.

User Account Types
There are two types of accounts that may be added, edited or deleted.
User Added Standard Accounts
Any user may add a standard level account. It is not necessary to select an accountbefore adding a new standard account.
Standard accounts may only modify or delete protocols or emails created from within
their account.

User Added Administrator Accounts•

An administrator level account may only be created by another administrator. The
primary administrator or another existing administrator account must be highlighted
in order to enable the adding of a new administrator.

•

Administrator accounts may modify or delete user entries of any sort created fromwithin any account. A drop-down menu is used to select the desired account.

•

Administrators may change the password for any account as well as delete any
account.

Account Passwords•

Passwords are optional for all added administrator or standard user accounts.

•

Contact the holder of an administrator account if a standard user account password
is forgotten.

•

Contact DeNovix customer support or your local distributor if the Primary
Administrator password is forgotten. Please have the serial number of the
instrument available when requesting help for the Primary Administrator password
reset.

Deleting an Account•When an account is deleted, all protocols and custom report formats created by that
account are reassigned to the General Account.

•

The account specific saved data will also be permanently removed from the
instrument at the time the account is deleted.

Tab - Email Addresses
Multiple “to” email addresses for exporting results may be set up for each account. The
nickname is used in the drop-down list presented on an export destination dialog box.
25

Tab - Defaults
Some application specific default settings may be defined on a per account basis.
Launch the Accounts app from the Home screen and then use the drop-down menus toselect the account, the app and the setting of interest.
Note: The default selections for the General Account may not be modified.

Data App
This app allows the user to search for past data by user account, date or application.
Data can then be added to the Report and Graph screens for review and export. Previous
results can be deleted from within the Data app.

Search Options• Data is automatically filtered based upon the Account selected using the tab on the top
action bar.
• Once the filter criteria have been selected, tap the Search button at the bottom of thescreen. Tap any column header to sort the results list.
• Highlight the sample(s) of interest and tap the Add to Report button to include thesamples on the Report screen.
• Data from the same app type for the samples to be added to the Report or Graph
screens. Clear the previous selects to find data from a different application.

Exporting and Deleting Data
• All data is automatically saved to the QFX on-board database at the time of
measurement.
• The Export Selected Samples function available from the Report screen are the same
options available in the Report screens discussed in the previous Data Export and Print
options section.
• When the export function is used, the data is not deleted from the database andcan be accessed using the Data app.
• The Delete function available from the Report and Graph screens.
• When the Delete function is used, the data is permanently deleted from the instrument
database and cannot be restored to the instrument.
• The storage capability of the QFX is sufficient for several years of data for a lab withaverage use.

26

Settings App
This app allows access to system information and settings. General accounts may see
basic system information. Administrator accounts can access the Permissions tab toadjust access to system settings. The Settings app provides access to the following
functions and information:

System Info

View software and firmware versions, IP addresses, current language and hostname.
Date/Time
Select manual or automatic date and time options.

Language
Select the language of operation for the device. Not all languages are fully translated.
Setting the language also determines whether a period or a comma is used for thedecimal place.

Network Information
The Wi-Fi and Ethernet MAC addresses and IP addresses can be found under this setting.
Permissions
Administrator level accounts can use Permissions to set access to the Settings app tabs
for general level accounts.

21 CFR Mode: Administrators can disable the “Discard” button from this screen if
desired.
Sound
Play a test sound.

27

Storage
Displays current storage statistics.
Wi-Fi

Turn Wi-Fi on or off and connect/disconnect from a network.
Connect the instrument to a 2.4 GHz or 5 GHz network.
Select the country where the unit is installed in order to ensure the Wi-Fi radio uses thecorrect frequency bands.
DeNovix instruments are compatible with eduroam using login credentials provided byyour institution. See Technical Note 225 on denovix.com for a step-by-step guide toconnect.
Ethernet
Ensure that the Ethernet cable is connected.

Tap the Edit button to configure Ethernet connection.
Contact your local IT department if additional help setting up Wi-Fi or Ethernet is needed.

Display

Includes controls for screen brightness and when the screen sleeps.

Network Folder
The instrument can export to SMB network folders connected to the same network as the
instrument. For best results connect to the network through an ethernet connection,
especially if exporting pdfs and images.

Enter the following information. See DeNovix Tech Note 122 or your IT Department for
additional help.
28•Name - Create a name for your network connection.

•

Server - The IP address of computer or server where the shared folder is located. The
IP can be found in Windows Network Status under “Properties” or byentering ipconfig at the Windows command prompt.

•

Domain name - The domain name when the shared folder resides. From a windows
command prompt enter echo %userdomain%. Do not include slashes orbackslashes.

•

Share path - The share name of the shared folder. In Windows, find this by rightclicking on the shared folder and viewing the properties. The share name should be asingle word. No slashes or backslashes.

The example below shows a correctly shared folder.

•

Mount point (optional) -The path to a subfolder within the main shared folder.
Example input sub1/sub2 is sub1 is a folder inside the main shared folder and sub2
is within folder sub1.

•

User name - The username accessing the share. No slashes or backslashes.

•

Password - Password of the User name account.

Press Connect to connect to the network folder. Press Send Test File to transfer a timestamped text file denovix.txt to the network folder.

Network Printing
Search and add compatible network printers for easy export of hard copy reports.

Email
Email Set-Up•

Ensure that the instrument is connected to Wi-Fi or Ethernet.

•

Launch the Settings app and navigate to the Email section on the left scroll menu.

•

Enable the POP3 option on your Email configuration. Do not use an IMAP account as
messages from IMAP accounts could occupy a significant amount of the
instrument's memory.

See Technical Note 205 on denovix.com for a step by step walkthrough of email setup.
Refer to your IT support group and DS-11 Series Technical Notes on denovix.com if
additional assistance is required.
29

Updater App
Updater is used to update system software and firmware to the most current available
versions. Updates may be downloaded using the Updater app when connected to
Ethernet or Wi-Fi. An Ethernet connection is recommended for software updates.
Updates may also be downloaded to a FAT32 formatted USB drive from our website.
Download the update file to the root directly of the USB drive. Do not change the file
name. Insert the USB drive in the device and then launch the Updater app. Follow the
onscreen instructions to update.

Note: The update process may require one or more automatic system reboots.

30

11. 21 CFR App
Compliance Ready Software
DeNovix 21 CFR Part 11 Compliance Ready Software is available for activation on DS-11
Series, QFX and DS-C instruments. An activation code is required and can be purchasedfrom DeNovix or a DeNovix distributor. Once activated, 21 CFR Mode provides a suite ofseamless, integrated controls for electronically signing records, managing user accounts,
configuring the organization and accessing the audit trail. The software enables thefollowing:•

A convenient configuration wizard for easy set up and customization during
activation.

•

User login with unique User ID and password for each user.

•

Operation as a closed system with a single, continuous period of controlled systemaccess.

•Users review results and electronically sign records while logged in. Records can beelectronically signed with a Signature Meaning that is associated with the user’s
assigned Role.

•

Prompt export (and back up) of electronically signed records to a second location
when completing a measurement session.

•

Export of human readable pdf reports and optional raw data such as csv files. The
pdf report includes details of each electronic signature associated with a record.

•

A user interface for viewing stored information but no ability to directly access andalter electronically stored data.

•

Administrator tools to customize and manage the organization’s Roles, Signature
Levels and Signature Meanings.

•

Administrator tools for User Account management including Role assignment,
activation, deactivation, name changes and password resets.

•

An Audit Trail function to automatically log system events and user activities in a
database. If audited, System Administrators can easily search the Audit Trail andexport a human readable .csv report.

31

Activation Wizard Overview
The activation wizard is a step-by-step procedure for setting up an instrument to comply
with your organization’s needs. Default valves are included but are fully configurable
during activation. 21 CFR Mode:•

Each user is assigned to Role•

Each Role has a Signature Level which establishes a rank in the organization•

A set of Signature Meanings must be defined (tested, rejected, approved, etc.)•

Roles are linked to one or more Signature Meanings, meaning that any User who isassigned to a Role can electronically sign a record with one of the available
signature meanings.

•

Once the organization rules are configured, each user is assigned to a Role. Thisestablishes the signature privileges of each user.

Activation Wizard 1/7 - Administrator AccountTo begin, open the 21 CFR app and select an Administrator level account from the
Account selector at the top of the screen. If a user created Administrator account isn’t
selected or none exists, the user is prompted to create a new Administrator account.
When 21 CFR Mode is activated, the open access accounts “General” and “Primary
Admin” are deactivated.

Activation Wizard 2/7 – Enter Activation CodeEnter the twenty-digit activation code and press Apply Code.

Activation Wizard 3/7 - Roles
Users will be assigned to a Role in the final step of activation. In this step set up theRoles for the organization. Each Role includes a value for Signature level. The Signature
Level value establishes a hierarchy in the organization. Users can view data for users attheir Signature Level and below. But they cannot view data for Roles with higher
Signature Level number.

32

Activation Wizard 4/7 – Signature Meaning
Each User, through their assigned Role, will be able to electronically sign records with the
Signature Meanings as defined in this table. Configure the Signature Meanings as
required for the organization but using the add, edit and delete icons. At least one
Signature Meaning must exist.

Activation Wizard 5/7 – Role-Signature Meaning Linking
In this step, set the Signature Meanings for each Role. Select a Role from the table andthen check Include to allow that Role to electronically sign records with that particularSignature Meaning. In the example shown, the Sr. Technician Role can e-Sign records
with Tested, Reviewed and Edit sample name/description Signature Meanings. Any Role
must be linked to at least one Signature Meaning.

33

Activation Wizard 6/7 – Password Rules
Set password rules as desired for the organization. Some requirements are optional.
Minimum password length and account locking after failed attempts to login are
requirements of 21 CFR Part 11 compliant software.

Activation Wizard 7/7 – Existing Users
The final step of the Activation Wizard is to complete the user records for any existinguser accounts that are on the system. Each user must have a User ID, First Name, LastName, Role and a temporary password set in order to complete the wizard. Edit user
accounts by selecting them from the list and then using the edit icon.
Note: This is last opportunity to delete existing user accounts. After 21 CFR activation iscompleted, user accounts may be deactivated, but they may not be deleted.

34

Measurements and Electronic Signed Records
DeNovix 21 CFR compliance ready software enables users to electronically sign results
according to their signature level and permissions established by a system administrator.
Organizations are responsible for establishing standard operating procedures to ensure
users and the organization comply with all facets of the 21 CFR regulations.
Blanks and Sample Measurements must be electronically signed.
Follow app specific instructions for creating methods or generating standard curves if
applicable.

After each measurement, the user must choose to Sign or Discard a result.
•Discard: The result is not saved. SOPs should be established related to the use of
discard to avoid ‘testing into compliance’ scenarios. The Discard button may bedisabled by an Administrator account using the Permissions tab in the Settingsapp.

•

Sign: With the first measurement of each session, the user must verify the user
ID and enter a correct password. Subsequent measurements are signed with theuser ID only.

Measure additional samples until ready to end the session.
DeNovix recommends that the users immediately export signed records and reports
when ending a session. As a reminder, at the end of each measurement session the user
will be asked if they would like to generate a 21 CFR Report for the session.
The 21 CFR Report is a non-editable, human-readable pdf report summarizing data fromall measurements within a session (or selected results within a session or the Data app).
The report includes result information, electronic signature details for each result and theMD5 (hash) value of a csv file of all data included in the report.

21 CFR Reports and csv should be backed up to a secondary location (USB drive, network
folder, hard copy to printer, etc.). The system administrator is responsible for ensuringsystems are properly backed up.
Standard curve replicates do not need to be signed. The values of all replicates used togenerate a standard curve are saved with each result. The user signs the measurement
which binds the sample result to the curve used to generate it.
35

Audit Trail
DeNovix 21 CFR software continually creates an Audit Trail which is a time-stamped log
of events and changes that take place in the system throughout the life of the instrument.
Administrators can search the audit trail to filter the results by date, Event Type, User ID
and Signature Meaning.

Event types tracked include Signature, System, User Account, Record Management andApplication/Machine errors. Some examples of logged events are the electronic
signature of a result, deactivating a user, a failed login attempt, exporting a result andarchiving a record. This list is only representative and is not a complete list of all actions
logged.
Set the filters as desired and press Search to update the result list. Select records andpress “Add to Report”. Move to the Report Tab to see additional information about each
audit trail entry. To export a copy of the Audit Trail as a .csv file, select records, press theexport icon and select the destination.

IMPORTANT NOTE FOR SYSTEM ADMINISTRATORS!
The Audit Trail should be backed up on a regular basis by a System Administrator.
DeNovix recommends that organizations establish procedures to regularly export the full
Audit Trail log via .csv to a backup file location.
36

Archiving
Results that have been previously exported from the instrument may be permanently
deleted through use of the Archiving function in the 21 CFR app. This is the only
mechanism for removing data from the instrument. Prior to removal, the Administrator
should confirm records that will be removed have been properly backed up to anotherlocation. Use the Data app to export additional copies of the electronically signed results
prior to archiving. Archiving immediately and permanently deletes all data associatedwith the signed record. Do not archive a record before confirming a secure copy of therecord exists in a secondary location or has been properly managed according to theorganization’s records retention policies. All Archiving events are captured in the Audit
Trail database.

Filter the results by date, App, User ID and Signature Type as desired. Touch Search to
update the search results. Select desired results and then Add to Report.

The Report tab view shows if a result has been previously exported from the system. Only
results that have been exported can be selected for archiving. Touch the delete icon toinitiate archiving. The system Administrator must enter their password to complete
archiving. The archived records are immediately deleted. Since the record has beenpreviously exported, an additional backup copy is not created at the time of archiving.

37

12. 21 CFR Mode - Utility Apps and Functions
21 CFR Mode Instructions

User
Accounts

Data

Settings

UpdaterThis section describes functionality for instruments that are running in 21 CFR Mode.
Please see the Utility Apps and Functions section for details about how the apps are
configured in Standard mode.

User Accounts App
System Administrators use the User Accounts app to create and manage user accounts
on the device. The app is also used for selecting roles, deactivating users, setting
temporary passwords and changing account information. Each user is required to have aunique User ID and password that meets the organization’s password rules set in the 21
CFR App. All User Account changes are captured in the 21 CFR Audit Trail data.
IMPORTANT: Organizations are responsible for following the strict security
requirements of 21 CFR Part 11 regulations. DeNovix software enables a method ofcompliance, but organizations are responsible for establishing and following
procedures to ensure compliance.

App Structure
User accounts are listed in the left pane of the screen. Within a user’s own account, tabs
in the right pane allow access to User Profile, Emails, Network Folders and Default
settings.

Administrators can access the Profile tab of other users by selecting that user from thelist in the left pane.
38

App Functions
Administrators have the following functions within the User Accounts app.
• Add accounts• Set Account Type• Assign Role
• Change first name or last name• Set Temporary Passwords• Deactivate / Reactivate accounts

Adding Accounts
Choose the + symbol from the left column to add a new user. Assign a User ID and theuser’s information. Create a temporary password for the new user. All users must have aunique User ID.

Account Type•

User – This account type has full access to count apps and permitted utility
apps. User account types do not have any access to Administrator level systemsettings. A user may change first name, last name or password of his/her own
account, but the user cannot change anything related to other user accounts.

•

Administrator – This user type has full access and control over all systemsettings. At least one Administrator account must always be active in 21 CFR
Mode. All Administrator accounts have the same administrative controls on thedevice.

Role
39

Each user must be assigned to an available Role as defined in the 21 CFR App. See 21
CFR App section for configuration details.

Account Passwords•

Passwords are required for all Users.

•

Password must follow the organization rules set in the 21 CFR App (special
characters, length, etc.)•

A user may not reuse a password they have previously used.

•

If a user is unsuccessful logging in over a set number of times (set in 21 CFRapp), the account is locked. An administrator can set a temporary password to
unlock the account.

•

Organizations are responsible for establishing password security procedures toensure compliance with 21 CFR Part 11requirements.

•

Contact DeNovix customer support or your local distributor if the sole
Administrator password is forgotten. Please have the serial number of the
instrument available when requesting help for the reset.

Deactivate / Reactivate an AccountUser accounts may be deactivated by an Administrator. Per 21 CFR Part 11 guidelines, auser account may not be deleted. User activation/deactivation is tracked in the Audit
Trail.

Tab - Email Addresses
Multiple “to” email addresses for exporting results may be set up for each account. The
nickname is used in the drop-down list presented on an export destination dialog box.

Tab - Defaults
Some application specific default settings may be defined on a per account basis.
Launch the Accounts app from the Home screen and then use the drop-down menus toselect the account, the app and the setting of interest.
Note: The default selections for the General Account may not be modified.

Data App
This app allows the user to search for past data by user, date or application. Data canthen be added to the Report and Graph screens for review and export.

Data may be filtered in the following ways from within the 21 CFR software:•App, Export status, User ID, Signature Type, date•Once the filter criteria have been selected, tap the Search button at the bottomof the screen. Tap any column header to sort the results list.

•

Highlight the sample(s) of interest and tap the Add to Report button to include
the samples on Results tab pages.
40•All data must be from the same app type for the samples to be added to theReport tab.

•Features and functions previously described for the Result screens apply to thecorresponding Data App Report screens.

ExportAll data is automatically saved to the onboard memory at the time of measurement andmay be exported as described in the previous section.
When the export function is used data is not deleted.
DeleteThe Delete function is not active for instruments in 21 CFR Mode. Data can only bearchived from the system by an Administrator through the 21 CFR app.

Settings App
See Settings App section in Utility Apps and Functions.

Updater App
This app can be opened by Administrator level user accounts when in 21 CFR Mode.
Updater is used to update system software and firmware to the most current available
versions. Updates may be downloaded using the Updater app when connected to
Ethernet or Wi-Fi. An Ethernet connection is recommended for software updates.

Updates may also be downloaded to a FAT32 formatted USB drive from denovix.com.
Download the update file to the root directly of the USB drive. Do not change the file
name. Insert the USB drive in the device and then launch the Updater app. Follow the
onscreen instructions to update.
Note: The update process may require one or more automatic system reboots.

41

13. Lab Tool Apps

Calculators

Timer

ScreenLocker

Calculator App
Three calculators are included within the app. Use the tabs in the top action bar tonavigate between the options.

Oligo Calculator
This calculator analyzes a user input ssDNA or RNA sequence of interest.
• Outputs include:• Length• Molecular Weight (g/mol)• GC Content• Mass Extinction Coefficient (µg/OD @260 nm): This result may be copied andpasted into the Factor Input field used for nucleic acid concentration calculations inboth the ssDNA and the Microarray apps.

• Melting Temp: For sequences up to 13 nucleotides, the equation used is Tm=(wA+xT) * 2 + (yG+zC) * 4 where w,x,y,z are the number of the bases A,T,G,C in thesequence. For sequences longer than 13 nucleotides, the equation used is Tm= 64.9
+41*(yG+zC-16.4)/(wA+xT+yG+zC). Both equations assume that the annealing
occurs under the standard conditions of 50 nM primer, 50 mM Na+, and pH 7.0.

Scientific Calculator
Use this calculator for standard mathematical and scientific functions.

Dilution Calculator
This calculator is a useful tool to calculate how much of a stock solution should be
added to a buffer solution to result in a final specified solution concentration.
• Both molar and mass units are available. However, conversions between the two typesof units are not enabled.

42

Timer App
This app is a lab tool that allows a user to set two independent timers.
• At the end of a specified period, an alarm will sound.
• Push the Off button to silence the alarm.
• The Timer will work in the background while other measurement apps are in use as
well as when the screen is in the dark screen saver mode.

ScreenLocker
Launch the ScreenLocker app from the Home screen prior to cleaning the touch screen.
This will disable swiping motions from activating other software activities. Tap the homebutton to exit.

4314. Maintenance
Guidelines• Use only a dry, soft, lint-free cloth to clean the front screen.
• Do not use a spray bottle to apply water or any other solutions onto any surface of the
instrument as the liquid may damage internal components.
• Hint: Launch the ScreenLocker app prior to cleaning the touch screen to prevent
swiping motions from activating other software activities.

Fluorescence Mode Holder Cleaning
The sample tube holder may be cleaned of excess dust using a damp (not wet) lint freecotton swab.
• Do not allow any liquid to drip into the holders as it may damage the internal
components of the instrument.

4415. Diagnostics
FX Diagnostics

FX Diagnostics
The FX diagnostics feature is available in all QFX units.

Procedure
1. Ensure FX sample measurement tube holder is empty and the lid is closed

2. Launch the FX Diagnostics app and push the Start button.
• Follow the on-screen instructions regarding tube insertion and orientation.
• The software tests that each LED is firing and each detector is functioning properly.
Results will be reported as Pass/Fail.

45

16. Troubleshooting
Fluorescence Mode
• Use 200 μL volumes in a clear thin-walled PCR tube
• Avoid introducing air bubbles into the sample solution when mixing samples.
• Ensure all sample concentrations in the thin-walled assay tubes fall within the limits of
the assay or reagent kit for accurate results.
• Follow assay reagent manufacturers' recommendations regarding temperature,incubation time, and protection from ambient light.
• Follow assay reagent manufacturers' recommendations regarding suggested standard
curve concentrations and data analysis.

• Confirm that the correct LED excitation source was used.
• Confirm that standard concentrations and dilutions were prepared correctly.
• Confirm that the correct concentration units for the standard curve and the unknown
samples were used to calculate the stock concentrations.

• Ensure that the correct optional dilution factor (or μL added in the case of Qubit and
DeNovix assays) is entered into the appropriate Run screen field before ameasurement is made.
• Ensure all samples and standards are treated identically in terms of incubation times
and temperature.

• Minimize assay tube and solution temperature fluctuations as these may impact theaccuracy of the measurement.
• Do not label the side of an assay tube as this could interfere with the sample
measurement.
Additional troubleshooting resources (technical notes and FAQ's) are available at our
website.

Software Errors
Pop-up messages will provide guidance for software-based errors or invalid user actions.
In most cases, simply relaunching the app or restarting the instrument will allow the user
to continue to make measurements. Update the software using the Updater app if
experiencing a reoccurring software error.

Printer and Barcode Scanner
The QFX is compatible with selected label printers* and Opticon OPI 3601 USB barcode
scanners. For accessory product troubleshooting and warranty information, pleasecontact the manufacturer of the product. DeNovix support is limited to the specific use of
the product with a QFX instrument.
*

Please refer to our website for a list of supported label printers.

46

17. Customer Support
DeNovix Inc.
3411 Silverside Road, Hanby Building
Wilmington, DE USA 19810
302-442-6911
info@denovix.com
Please include the serial number of your instrument when contacting Customer Support
by email. If sending Customer Support a Screen Capture or a report .csv file using the
QFX email feature, include your name, institute/company, phone number and return email
address. Please note responses will not be sent directly to the email account used by
the instrument.
From the Diagnostics App use the overflow menu to access the TechSupport filepackage. Include those files, when possible, with a request for support.
Outside of the US, please contact your local distributor for assistance.

Warranty
All product(s) and accessories sold by DeNovix Inc. are under warranty against
manufacturing defects in parts.

Disclaimer
All information in this document is for reference purposes only. DeNovix Inc. makes noclaims that this document is complete or error-free and assumes no responsibility andwill not be liable for any errors, omissions, damage or loss that might result from any useof this document. The information in this document is updated frequently and may be
updated at any time. Visit denovix.com to obtain the latest version.

Instructions for Disposal of Packaging and Waste Equipment
DeNovix encourages customers to locally recycle shipping and packaging materials.
Corrugated cardboard and paper can be recycled wherever it is accepted locally (e.g.,curbside bins, recycling facilities, etc.). For foam and plastics, please contact your local
recycling office for information on how to recycle.
When an instrument has reached its end of life, DeNovix recommends that customers
responsibly dispose of the equipment by following in line with local regulations. Material
construction is available upon request. Visit denovix.com/sustainability for more
information.

Research Use Only
DeNovix Inc. products are for research use only.
Qubit, Quant-iT, PicoGreen and OliGreen are trademarks of Thermo Fisher Scientific and its subsidiaries. QuantiFluor is atrademark of Promega Corporation.

47