GeminiBio Orflo Moxi V User Manual
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GeminiBio Orflo Moxi V User Manual

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  • Page 1 a subsidiary of USER GUIDE For Research Use Only. Not For Use In Diagnostic or Therapeutic Procedures.
  • Page 2 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 2 of 108 Title: Moxi V – User Guide This document is provided to customers who have purchased Orflo Technologies, LLC (“Orflo”, a subsidiary of Gemini BioProducts, LLC) equipment, software, reagents and consumables to use in the operation of such Orflo equipment, software, reagents, and consumables.

  • Page 3: Table Of Contents

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 3 of 108 Title: Moxi V – User Guide Contents INTRODUCTION ..............................1 ABOUT THE USER GUIDE ............................1 CONVENTIONS USED IN THE USER GUIDE ......................2 SAFETY PRECAUTIONS ............................2 ................................
  • Page 4 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 4 of 108 Title: Moxi V – User Guide ................................25 ESULTS Recorded Channels ............................. 25 Data Display Formats – General Output Types ....................26 Fluorescence vs Size Scatter Plot ............................27 Histograms ..................................
  • Page 5 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 5 of 108 Title: Moxi V – User Guide Password Expiration ............................67 Secure Mode ............................... 67 ................................67 YSTEM OGIN ..............................68 DMINISTRATION Adding a User ..............................68 User Roles ................................70 Modifying Users ..............................

  • Page 6: Introduction

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 1 of 108 Title: Moxi V – User Guide Introduction The Moxi V™ from Orflo Technologies (a subsidiary of Gemini BioProducts, LLC) is a benchtop instrument that utilizes a disposable thin-film cassette and a combination of a 532 nm laser, one PIN diode (with a 561nm/LP filter), Coulter Principle-based cell measurements, and on-board software to provide easy-to-run applications and data analysis.

  • Page 7: Conventions Used In The User Guide

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 2 of 108 Title: Moxi V – User Guide To update the Moxi V firmware to the latest version, please visit http://www.orflo.com, and register your instrument by entering a valid email address and serial number. The registration key provided after registering will allow users access future firmware updates.

  • Page 8: Laser Safety

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 3 of 108 Title: Moxi V – User Guide parts. All service must be performed by ORFLO, or an approved ORFLO vendor. Laser Safety WARNING The Moxi V is a Class 1 laser product in accordance with IEC 60825-1:2007. The system contains a Class IIIb laser that operates at 532 nm with a maximum output power of 50 mW.
  • Page 9 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 4 of 108 Title: Moxi V – User Guide Page 4 ™ Moxi V User Guide...

  • Page 10: Moxi V™ System Overview

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 5 of 108 Title: Moxi V – User Guide Moxi V™ System Overview ™ The Moxi V Kit includes the Moxi V system, USB Cable (mini USB B to USB A 2.0), USB Power Adapter, one pack of 25 Type S+ (MXC030) Cassettes, a spare cassette tray insert, and a Quick Start Reference Guide.
  • Page 11 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 6 of 108 Title: Moxi V – User Guide Power/Reset Button USB Cable Port (on back surface) TouchScreen Display Cassette Tray Door Disposable Cassette Page 6 ™ Moxi V User Guide...

  • Page 12: Moxi Vtm Accessories

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 7 of 108 Title: Moxi V – User Guide Component Function Touch Screen Display Allows user to interface with the instrument by pressing icons and targets. Displays all information needed for operation and analysis of results.

  • Page 13: Getting Started

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 8 of 108 Title: Moxi V – User Guide USB Cable Connects instrument to Personal computer (PC or Mac) or power adapter Extra tray insert can be user-installed in Cassette Tray Insert cassette tray when adhesive build-up interferes with insertion/removal of cassettes.

  • Page 14: Additional Materials Required

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 9 of 108 Title: Moxi V – User Guide Cells should be suspended in 0.9% salt solution (e.g. PBS or equivalent) to ensure proper conductivity for unit operation and to ensure proper particle sizing. Water, hypotonic, or hypertonic solutions are not acceptable diluents.

  • Page 15: Using The Moxi V

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 10 of 108 Title: Moxi V – User Guide Using the Moxi V Press the Power Button to turn on the instrument. The Home Screen will become available. The image below identifies the key items on the Home Screen. Page 10 ™...

  • Page 16: Home (Start) Screen

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 11 of 108 Title: Moxi V – User Guide Home (Start) Screen Battery/ Charging Indicator Date/ Time Indicator Assays /Applications Help Instructions User Saved USB Disk Administration Data/Tests (secure mode) (data System System Applications...

  • Page 17: Settings

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 12 of 108 Title: Moxi V – User Guide NOTE: The home page appearance may change as additional applications are launched and new GUIs (graphical user interface buttons) are added to the Moxi V software program. Settings Fluorescence Gain The “Fluorescence Gain”...

  • Page 18: Auto Noise-Find

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 13 of 108 Title: Moxi V – User Guide Auto Noise-Find This field sets the behavior of the system with respect to identifying system noise during tests. There are two possible settings: Yes or No. If set to Yes, the system applies an algorithm to each test, after acquisition, to try to identify the noise (and small-particle “debris”) in the sample.
  • Page 19 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 14 of 108 Title: Moxi V – User Guide conductive media. The target solution conductivity would be 0.9% salt solution (e.g. PBS or equivalent). Deviations of +/- ~50% conductivity can be tolerated by the system. Most medias that are isotonic to PBS will work.

  • Page 20: Running A Test

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 15 of 108 Title: Moxi V – User Guide be applied but users should be aware that those approaches have limited efficiency and can still leave a significant number of intact RBC’s behind. Running a Test Instructions – Cell Count (Size + Viability), PBMC Check, CAR T Expansion Tests •...

  • Page 21: Loading A Sample

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 16 of 108 Title: Moxi V – User Guide a. System status messages are displayed in the black bar at the top of the screen. b. For the first test-run on the unit, following power up, an initial laser “cam align”...
  • Page 22 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 17 of 108 Title: Moxi V – User Guide Notes: • To load the sample, place the pipette tip directly in the loading oval (touching the cassette with the tip is perfectly fine and recommended). •...

  • Page 23: "Cell Qc" Test

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 18 of 108 Title: Moxi V – User Guide • Dispense the fluid in one, smooth motion as you would normally during pipetting. The system does apply a slight vacuum to pull the fluid in, but it is not recommended to try to “time the load”...

  • Page 24: Cell Qc - Single Run

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 19 of 108 Title: Moxi V – User Guide providing for rapid acquisition of data, provides the same simplified output for each test, along with a final summary .csv (e.g. Excel) output file with the summary data for all tests. Touching the “Cell QC”...

  • Page 25: Cell Qc - Start Batch

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 20 of 108 Title: Moxi V – User Guide drop-down list with the options of entering “1:1” (no dilution), “1:2” (2x dilution), “1:5” (5x dilution), and “1:10” (10x dilution). Note: the value selected here will automatically be applied to the test count output to adjust the measured counts for the dilution level, providing the true (dilution adjusted) initial starting concentration.

  • Page 26: Cell Qc - Initial Test Output (Both Single Run And Batch)

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 21 of 108 Title: Moxi V – User Guide can be used as general text description of the sample/test being run. This field can be changed by touching in the box and using the keyboard below to type a description. The Sample ID field can be changed for each/any test in the batch.
  • Page 27 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 22 of 108 Title: Moxi V – User Guide displayed. This initial screen is designed to provide a simple representation of all the cell/sample data based on the system auto-gating of the fluorescence (Propidium Iodide, Viability) vs Size scatter plot (more detail below) to identify the core cell population (by size) and determine the viability (by PI fluorescence).

  • Page 28: Cell Qc - Test Output - Continuing Batch Testing

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 23 of 108 Title: Moxi V – User Guide Cell QC – Test Output – Continuing Batch Testing Touching the “Save” button for a Batch Run will save the latest data/test (.FCS format) and result in a user prompt as to whether the user wants to continue running tests in the batch. As long as the user touches “Yes”...

  • Page 29: Cell Qc - Batch Run - Saved Data And .Csv Summary File

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 24 of 108 Title: Moxi V – User Guide Cell QC – Batch Run – Saved Data and .CSV Summary File The batch information is all contained in a sub-folder (under the “Test-Files” main folder) of the Moxi V µSD data disk. Within that folder, all the test FCS (.fcs) files are saved, any generated screenshot files, and the batch summary file “Batch_summary.csv”...

  • Page 30: Cell Qc - "Add To Existing Batch

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 25 of 108 Title: Moxi V – User Guide Cell QC – “Add to Existing Batch” To append data to existing batch, the user can simply select the “Add to Existing Batch” icon (see above/left) at the first “Cell QC” configuration screen. The system will provide the standard warning (yellow pop-up, see above/left) that batch mode is meant for samples of the same type.

  • Page 31: Data Display Formats - General Output Types

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 26 of 108 Title: Moxi V – User Guide Data Display Formats – General Output Types Certain tests (PBMC Check, CAR T Expansion, and Cell QC) provide simplified data outputs, presenting just the essential test information based on auto-gating algorithms implemented by the system.

  • Page 32: Fluorescence Vs Size Scatter Plot

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 27 of 108 Title: Moxi V – User Guide Fluorescence vs Size Scatter Plot Test name Population % Test type Toggle between Total size-gated gates: Size (blue), (between blue gates) fluorescence (red), counts and noise (yellow) Left size marker Right size marker adjust (drag to move)
  • Page 33 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 28 of 108 Title: Moxi V – User Guide Page 28 ™ Moxi V User Guide...

  • Page 34: Histograms

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 29 of 108 Title: Moxi V – User Guide Histograms Page 29 ™ Moxi V User Guide...
  • Page 35 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 30 of 108 Title: Moxi V – User Guide Test type Test name Viability % (touch to change) (defined by red and blue gates) Swipe up/down in Histogram area to change y-axis scale Histogram bin counts Lower (negative/low...

  • Page 36: Reading Raw Data Output (Conc., Size, Mfi, And %)

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 31 of 108 Title: Moxi V – User Guide Reading Raw Data Output (Conc., Size, MFI, and %) The Moxi V™ provides particle concentration and precise sizing information for each gated region, total counts information, fluorescent percentages, and median fluorescent intensities (all where applicable based on the channels selected) for each test.

  • Page 37: Single Channel Histogram Plot

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 32 of 108 Title: Moxi V – User Guide percentage of events that fall above/below the fluorescence (red) gate is displayed in the yellow box above the scatter plot (e.g. 39.4% in this example). Single Channel Histogram Plot Image above/right: An example of the on-unit histogram display for the PIN diode (561nm/LP fluorescence) Only the points within the size-gated region for the fluorescence channel vs.

  • Page 38: "Pbmc Check" Output

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 33 of 108 Title: Moxi V – User Guide All data outputs are discussed in detail below first for test-specific and simplified outputs followed by general gating instructions (for the three main data formats) in the “Manual Gating” section.
  • Page 39 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 34 of 108 Title: Moxi V – User Guide The data scatter plots/histograms and associated system-set gates can be viewed and adjusted by the user. It is recommended, particularly for the first test in a sequence of experiments, that these gates be checked by the user.

  • Page 40: "Car-T Expansion" Output

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 35 of 108 Title: Moxi V – User Guide “CAR-T Expansion" Output The initial, simplified output of the CAR-T test is shown below. This output is based on the system’s auto-gating of the Pin DIode (Propidium Iodide, Viability) vs Size scatter plot (more detail below) to identify the core CAR-T population (by size) and determine the viability (by PI fluorescence).

  • Page 41: Cell Qc" - Output (Both Single Run And Batch)

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 36 of 108 Title: Moxi V – User Guide moved by touching and dragging the markers (blue for size gates, red for fluorescence gate, yellow for noise gate). The gate mode (size, fluorescence, noise) can be toggled by touching the red icon at the top/right of the plot.
  • Page 42 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 37 of 108 Title: Moxi V – User Guide An example of the Initial Cell QC “Results Summary” is shown in the image above/left. This initial screen is designed to provide a simple representation of all the cell/sample data based on the system auto-gating of the Pin Diode (Propidium Iodide, Viability) vs Size scatter plot (more detail below) to identify the core cell population (by size) and determine the viability (by PI fluorescence).

  • Page 43: Analyzing/Gating The Data

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 38 of 108 Title: Moxi V – User Guide Analyzing/Gating the Data For tests other than the PBMC, CAR-T, and Cell QC tests, the test results are presented to the user immediately following a test in the form of a scatter (dot) plot (below/left) for fluorescent tests or as a size-only histogram (below/right, “Size Histogram”...

  • Page 44: (General) Recommended Post-Test Workflow

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 39 of 108 Title: Moxi V – User Guide (General) Recommended Post-Test Workflow Adjust the Define Define the +/- Define the Read results size (x) population by & perform file axis to analysis adjusting the population operations optimize...

  • Page 45: Gating The Data

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 40 of 108 Title: Moxi V – User Guide Rescaling the axis results in reprocessing of the raw data to ensure that resolution is not lost during the rescale process (1000 histogram bins). This allows (and is recommended for) users to achieve finer resolution of smaller particle populations and potentially increased separation between particle sub-populations.
  • Page 46 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 41 of 108 Title: Moxi V – User Guide corresponding sections below. Please note that using “histogram overlays” of the scatter plot can greatly facilitate the placement of the gates (refer to section on “Histogram Overlays on Fluroescence vs.

  • Page 47: Size Gating Of Scatter (Dot) Plots

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 42 of 108 Title: Moxi V – User Guide Size Gating of Scatter (Dot) Plots The results of all fluorescent tests (all tests except for the “Size Histogram” test) are initially displayed as scatter plots with the size (blue) gates enabled (see image above, left). Gates can be adjusted by touching and dragging the blue markers around the edges of the scatter plot (above).

  • Page 48: Fluorescent Gating Of Scatter (Dot) Plots

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 43 of 108 Title: Moxi V – User Guide be placed in the valley between the populations (use histogram overlays to help identify precise location). Fluorescent Gating of Scatter (Dot) Plots Touching the red gate toggle marker when the size (blue) markers are currently enabled correspondingly disables the (blue) size gate markers and enables the (red) fluorescent gate markers.

  • Page 49: Noise Gating Of Scatter (Dot) Plots

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 44 of 108 Title: Moxi V – User Guide Noise Gating of Scatter (Dot) Plots Touching the red gate toggle marker when the fluorescent (red) markers are currently enabled correspondingly disables the (red) fluorescence gate markers and enables the (yellow) noise gate markers.

  • Page 50: Store And Recall Of Gate Settings

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 45 of 108 Title: Moxi V – User Guide Store and Recall of Gate Settings Moved Gates If the system auto-gating is not enabled for a particular test, the Moxi V™ gates are then “sticky” by default. “Sticky” means that each new test defaults to the gate settings (size and fluorescence) of the prior test.

  • Page 51: Histogram Overlays On Fluorescence Vs Size Scatter Plots

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 46 of 108 Title: Moxi V – User Guide Histogram Overlays on Fluorescence vs Size Scatter Plots Fluorescent and Size histograms overlays on the scatter/dot plot can be toggled on and off by pressing the blue histogram button at the bottom right of the scatter plot (see images below). With histogram overlays turned on, the fluorescent histogram appears as a blue histogram with a base on the left (fluorescent) axis (blue dashed lines point to the histograms in the images below).
  • Page 52 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 47 of 108 Title: Moxi V – User Guide fit automatically. The system uses the mean of the Gaussian to determine (and report) the singlet cell size/volume (black box in the bottom right). For smaller particle populations, improved size resolution can be achieved by rescaling the x- axis (as discussing in the above “Rescaling the X-axis”...
  • Page 53 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 48 of 108 Title: Moxi V – User Guide Page 48 ™ Moxi V User Guide...

  • Page 54: Changing Display Axis For Tests (Fluorescence Vs Size, Histogram Only Views)

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 49 of 108 Title: Moxi V – User Guide Changing Display Axis for Tests (Fluorescence vs Size, Histogram Only Views) Y-axis Select X-axis Select FLUO FLUO Page 49 ™ Moxi V User Guide...
  • Page 55 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 50 of 108 Title: Moxi V – User Guide The test output can be modified to display any recorded channel vs another channel or, individually, with a histogram-only view. The change the display axis, the X/Y button (image below, frame at the top/right) can be selected.

  • Page 56: File/Test Operations

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 51 of 108 Title: Moxi V – User Guide File/Test Operations Test Naming and Renaming Tests By default, tests are named with an automated prefix based on the test type (“Via” for Cell Counts (Size + Viability), “PBMC” for PBMC Check, “CAR” for CAR-T Expansion, “QC” for Cell QC, and “Size”...

  • Page 57: Exporting Data Screenshots

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 52 of 108 Title: Moxi V – User Guide button will appear as Done instead), Print (see below), or Delete a test. Selecting Save results in the data being written out to the user disk in FCS 3.1 format for retrieval on a Mac/PC or for later retrieval from the Saved Data area (button off of the Home screen).

  • Page 58: Editing Saved Tests

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 53 of 108 Title: Moxi V – User Guide Editing Saved Tests All saved tests can be accessed by touching the Saved Tests icon from the Home screen. Doing so provides a list of all files stored on the Moxi V™. File types are color coded (image below) as follows: •...
  • Page 59 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 54 of 108 Title: Moxi V – User Guide Tests can be sorted by either Name, Date, or Type (FCS, BMP, etc.) by touching the corresponding icon in the “Sort by” field at the bottom left of the screen. Touching the same icon (e.g.

  • Page 60: Compare/Overlay Saved Tests

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 55 of 108 Title: Moxi V – User Guide Test files and screenshot files can be opened by simply touching the green (or dark gray row). An example is shown in the image above (frames from top/middle to bottom/left on touching the “QC-001”...
  • Page 61 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 56 of 108 Title: Moxi V – User Guide overlays. Once that size region is properly defined, touching Next will display the histogram overlay (image below bottom/right) of the two data sets for the PIN Diode (561nm/LP). The fluorescence histogram for the designated “control”...
  • Page 62 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 57 of 108 Title: Moxi V – User Guide Page 57 ™ Moxi V User Guide...

  • Page 63: Exporting Data - Connecting Via Usb (Usb On-The-Go)

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 58 of 108 Title: Moxi V – User Guide Exporting Data – Connecting Via USB (USB on-the-go) Each saved Moxi V™ test is saved in the Flow Cytometry Standard (FCS) v3.1 format (International society for Advancement of Cytometry, http://isac-net.org) and can correspondingly be opened by any commercially available FCS v3.1 compatible software package (e.g.

  • Page 64: Put The Moxi V Tm In Usb Connect Mode

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 59 of 108 Title: Moxi V – User Guide Put the Moxi V in USB Connect mode Page 59 ™ Moxi V User Guide...
  • Page 65 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 60 of 108 Title: Moxi V – User Guide Touch the “USB Disk” icon (image above/left) Touch the “Connect Disk” icon (image above/middle) iii. Wait for the “Connected” icon to light up (image above/right). Notes: •...

  • Page 66: Safely Disconnect Moxi V

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 61 of 108 Title: Moxi V – User Guide Safely disconnect Moxi V from the Computer Safe-eject the Moxi V drive from the computer. • Windows: Click on the “Safely Remove Hardware” icon in the system tray (bottom right of Windows taskbar).

  • Page 67: Moxi Vtm Apps

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 62 of 108 Title: Moxi V – User Guide 2. Press the Next icon to view the next visual instruction that demonstrates how to pipette a sample into the cassette. 3. Press the Next icon to proceed to the next instruction screen or press the Previous icon to return to the previous screen.
  • Page 68 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 63 of 108 Title: Moxi V – User Guide • Clock • Timer (with sound notification) • Loader – Puts unit is Firmware/OS loader mode • Restart – Reboots the unit •...

  • Page 69: Cfr Part 11 Operation ("Secure Mode")

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 64 of 108 Title: Moxi V – User Guide 21 CFR Part 11 Operation (“Secure Mode”) Overview With v2.12 of the Moxi V firmware, the system can be set to operate in a 21 CFR, Part 11 compliant manner.
  • Page 70 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 65 of 108 Title: Moxi V – User Guide Password: reset Gembio-provided activation code Page 65 ™ Moxi V User Guide...

  • Page 71: Secure Mode - Key Settings

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 66 of 108 Title: Moxi V – User Guide (see Roles section below). The system will walk this new admin user through the process of entering their full name and password, as shown in the images below. The process of doing, as indicated by the final acceptance screen, is the process of setting up the electronic signature for that user.

  • Page 72: Idle Shutdown Timer

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 67 of 108 Title: Moxi V – User Guide Descriptions of those key settings are described below. Idle Shutdown Timer Time period for system to automatically go to sleep (and log out the user if Secure Mode is On). Tap field to toggle values.

  • Page 73: User Administration

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 68 of 108 Title: Moxi V – User Guide that only the initial “admin” user can login by touching the “Admin” button. That user can also login through the “User” section. With Secure Mode activated, a new Users button shows, allowing for administration of all system operators.
  • Page 74 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 69 of 108 Title: Moxi V – User Guide When setting up each and every user, it is important to emphasize to that user that every entry of the User ID and Password combination, during system operation, constitutes a “signature” event.

  • Page 75: User Roles

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 70 of 108 Title: Moxi V – User Guide User Roles The Moxi V firmware classifies users into three separate roles: Normal Users (“Users”), Reviewers, and Administrators (“Admins”). Details on the privileges associated with each role are outlined below.

  • Page 76: Modifying Users

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 71 of 108 Title: Moxi V – User Guide § Auto Gate Setting § Idle Shutdown Timer § Password Expiration period § Secure mode On/Off Toggle o Delete saved data o Format the data disk o Mount/connect system as an external disk to a computer via USB, allowing access to: §...

  • Page 77: Deleting Users

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 72 of 108 Title: Moxi V – User Guide Deleting Users Only users with “Administrator” privileges can delete other user accounts. The Administrator would access the Remove a User” area (image below/left) by touching Users off of the Home screen.

  • Page 78: Running Tests - Secure Mode

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 73 of 108 Title: Moxi V – User Guide Running Tests – Secure Mode This section describes the specific features associated with running tests in Secure Mode. For more detailed test instructions, please refer to the appropriate test (“Running a Test” and “Analyzing/Gating the Data”) instructions above.
  • Page 79 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 74 of 108 Title: Moxi V – User Guide FCS 3.1 Data File w/Signature Log Page 74 ™ Moxi V User Guide...

  • Page 80: File Save Formats

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 75 of 108 Title: Moxi V – User Guide File Save Formats When in Secure Mode, the data is automatically saved in two formats: FCS (data) and BMP (image) for every save event. FCS data First, a flow cytometry standard (FCS 3.1) file is generated that contains the test information, binary data, and log events for the data set.

  • Page 81: Reviewing Data - Secure Mode

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 76 of 108 Title: Moxi V – User Guide • MM is the minute • SS is the second. The BMP file provides a human-readable, unalterable snapshot of the data/results at that point in time for record-keeping purposes.
  • Page 82 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 77 of 108 Title: Moxi V – User Guide Saved Bitmap Reviews can be initiated by Normal Users. The Normal User can enter the Saved Data section, Open a file, adjust a gate, and save the data. However, in order to save the data, they would need a Reviewer or Admin to approve the change.
  • Page 83 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 78 of 108 Title: Moxi V – User Guide sequence above. The general editing is the same as without Secure Mode. However, once the image is saved, the system walks the user through (bottom row of images) getting a Reviewer- level user’s approval.

  • Page 84: System Event Logging - Secure Mode

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 79 of 108 Title: Moxi V – User Guide Following the save, the system will fully log changes in both the FCS data file as well as with a bitmap image with a snapshot of the data, the signature of the user that modified the data, and the Reviewer’s signature event.

  • Page 85: Log File Naming

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 80 of 108 Title: Moxi V – User Guide Log File Naming Log files are generated on a weekly basis with the following naming format “SysLog- YYYYMMDD-HHMMSS.csv” where the following parameters correspond to the creating date/time of the log file: •...

  • Page 86: Backing Up / Transferring Data - Secure Mode

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 81 of 108 Title: Moxi V – User Guide • System Power-on • System Power-down. Backing up / Transferring Data – Secure Mode Only users with Administrator privileges can access data on the Moxi V once Secure Mode has been enabled.

  • Page 87: Instrument Firmware And Software Upgrades

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 82 of 108 Title: Moxi V – User Guide Instrument Firmware and Software Upgrades This User Guide describes OS version 2.12 of the Moxi V™ firmware. The firmware may be updated periodically. For information on the most up-to-date firmware, visit the ORFLO website at www.orflo.com.

  • Page 88: Data (Μsd) Disk Format (Strongly Recommended)

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 83 of 108 Title: Moxi V – User Guide DATA (µSD) DISK FORMAT (STRONGLY RECOMMENDED) For optimal performance (i.e. file/image save speed), it is strongly recommended that you format the Moxi V Data (µSD) Disk following the firmware installation. Formatting the disk requires connecting the system to Windows laptop.
  • Page 89 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 84 of 108 Title: Moxi V – User Guide 7. BACKUP/COPY all the data on the disk to the computer. THIS IS CRITICAL AS THE NEXT STEPS WILL REMOVE ALL DATA FROM THE DEVICE 8.
  • Page 90 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 85 of 108 Title: Moxi V – User Guide 10. Make sure “Quick Format” is checked and type a volume name (e.g. “MoxiV”) 11. Select “Start”. The format should take less than a minute. 12.

  • Page 91: Moxi V - Tray Insert Replacement Procedure

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 86 of 108 Title: Moxi V – User Guide Moxi V – Tray insert replacement procedure Background The Moxi V has a tray design that allows users to address the occasional need to clean the system cassette tray of adhesive build-up.

  • Page 92: Installing An Insert

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 87 of 108 Title: Moxi V – User Guide 2. Gently lift up on the center tab (red arrow in images below) of the tray insert while pulling out to slide the insert out. Pull insert all the way out. (Refer to images below) Installing an insert IMPORTANT: Make sure to unplug Moxi V USB/Power cable from system before starting this procedure.
  • Page 93 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 88 of 108 Title: Moxi V – User Guide Tray Guides Insert Rails 3. Push the cassette insert into the system. Page 88 ™ Moxi V User Guide...

  • Page 94: Troubleshooting

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 89 of 108 Title: Moxi V – User Guide 4. Once the insert is all the way in, try closing the cassette door. If insert is properly installed, door should close all the way. If the door doesn’t close, try to push the insert further in.
  • Page 95 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 90 of 108 Title: Moxi V – User Guide If the above steps don’t resolve the issue, it is Pump error possible there is an error with the instrument pump. Contact ORFLO Technical Support. Reset instrument by pressing and holding the Internal firmware issue due to power button for at 10 seconds.
  • Page 96 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 91 of 108 Title: Moxi V – User Guide Ensure the cells are in a single-cell suspension. Break clumps by pipetting up and down with a Cell clumping standard pipette. Protease treatment can also be used to dissociate clusters.
  • Page 97 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 92 of 108 Title: Moxi V – User Guide Make certain that the particle type is within the Cells/beads too large specified size range of the cassettes being used Highly/strongly aggregated cells Try breaking apart cells using pipette trituration clogging filter and blocking flow and/or protease treatment.
  • Page 98 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 93 of 108 Title: Moxi V – User Guide Test Error: Fluid was not Sample not loaded or volume too Make sure sample is loaded and volume is at Detected small least 60 µL.

  • Page 99: Maintenance And Storage

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 94 of 108 Title: Moxi V – User Guide Maintenance and Storage Storage Store the Moxi V and Cassettes at room temperature in a dry environment. For best results, cassettes should be used within one year of purchase. Avoid prolonged exposure to ultraviolet light as it may degrade the touch screen display or discolor the external surfaces of the instrument.
  • Page 100 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 95 of 108 Title: Moxi V – User Guide The Moxi V contains a 3.7 V, 7500mAh lithium ion battery. The battery is incorporated in the system only to buffer the power surges that occur during the activation of the laser and to ensure that a temporary unplugging of the system does not result in a power-off.
  • Page 101 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 96 of 108 Title: Moxi V – User Guide CAUTION: When sanitizing, make certain that no liquid enters any internal cavities of the instrument. This could result in damage to the instrument. Maintenance There is no routine maintenance required for the Moxi V .

  • Page 102: Specifications For The Moxi V

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 97 of 108 Title: Moxi V – User Guide ™ Specifications for the Moxi V and Cassettes System Performance Detection Parameters 3 (561nm/LP fluorescence, cell count and cell size) Excitation Laser Wavelength 532 nm Fluorescence Detection 561nm/LP filtered PIN diode...
  • Page 103 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 98 of 108 Title: Moxi V – User Guide updates are offered both to fix bugs as well as to enable new functionality. Offline analysis requires FCS v3.1 compatible software package for viewing files (e.g., FlowJo X or FCSExpress Physical Attributes Benchtop Dimensions (HxWxD)

  • Page 104: Ordering Information

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 99 of 108 Title: Moxi V – User Guide Ordering Information This section lists catalog numbers for the Moxi V and related products. You can purchase ORFLO products through a regional distributor or on-line at www.orflo.com. See the Technical Assistance section for information about contacting ORFLO.

  • Page 105: Warranty

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 100 of 108 Title: Moxi V – User Guide Warranty What is Covered By Your Warranty ORFLO Technologies warrants its products will meet their applicable specifications when used in accordance with their published instructions* The ORFLO product warranty is a “bumper to bumper”...

  • Page 106: Applicable Patents

    Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 101 of 108 Title: Moxi V – User Guide If your issue remains unresolved after consulting with one of our technicians, ORFLO will provide a Returned Material Authorization (RMA) number and you will be asked to ship your product back to our repair facility.
  • Page 107 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 102 of 108 Title: Moxi V – User Guide Document # Revision # Reason MXV.SYS.004 2.12 21 CFR, Part 11 Release Functionality Page 102 ™ Moxi V User Guide...
  • Page 108 Document # MXV.SYS.004 Effective: 30JUL2021 Revision # 2.12 Page 103 of 108 Title: Moxi V – User Guide A subsidiary of Page 103 ™ Moxi V User Guide...

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