Summary of Contents for InDevR Vaxarray
- Page 1 Imaging and Analysis System Operation Manual © Copyright 2014-2018, InDevR, Inc. All rights reserved 2100 Central Ave, Suite 106, Boulder, CO 80301 www.indevr.com | 303.402.9100 | indevr@indevr.com...
- Page 2 Revised : June 2018 InDevR continuously optimizes products as new technologies are developed. For this reason, the right to make technical changes is reserved. Defects caused by unauthorized alterations to the product by the user voids the warranty. InDevR shall not be held liable for damages caused by unauthorized modifications.
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Page 3: Table Of Contents
............................22 ENERATING A EPORT OPENING PREVIOUSLY RUN EXPERIMENTS ....................24 ACCESSING VAXARRAY IMAGING AND ANALYSIS SYSTEM SETTINGS & INFORMATION ........26 MANAGING USER ACCOUNTS ........................28 Adding a new User ............................28 Removing a User .............................. 28 Adding a User to a Specific User Group ......................28 Changing Administrator Privileges ........................ - Page 4 ............................31 AILURE TO IND AN RRAY ................................31 LEANING .................................. 31 ERVICE ................................32 HIPPING ........................32 ROPER ISPOSAL OF THE NSTRUMENT TRADEMARKS .............................. 33 SPECIFICATIONS ............................33 Page 4 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004...
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Page 5: General
General This manual provides all information for the setup and use of the InDevR VaxArray Imaging and Analysis System. Document Conventions This symbol is used to indicate safety instructions and similar important information. Follow these instructions to avoid personal injury or damage to the instrument. -
Page 6: Conformity To Standards, Norms And Regulations
21 CFR Part 11 and Annex 11 The VaxArray Imaging and Analysis System is designed to operate within FDA 21 CFR Part 11 and Annex 11 compliant facilities. Please reference VaxArray Enabling Compliance with 21 CFR Part 11 and Annex 11 for further details. -
Page 7: Package Contents
FDA 21 CFR Part 11 or Annex 11 guidance. The VaxArray Imaging and Analysis System has been validated for use with the Windows 7 operating system. Use with other operating systems has not been validated and may effect system performance. -
Page 8: Installation
Installation This section provides a description of the instrument (Figure 1) and instructions for installation. For a detailed explanation of instrument maintenance and service, please refer to Page 8 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004... -
Page 9: Nstallation
Troubleshooting, Cleaning, and Service. Installation A. The VaxArray Imaging and Analysis System is shipped with two transportation locks to avoid damage during shipment. The two lock screws fix the position of the imaging tray during transport. One is placed on the right side and one on the rear of the system. Remove the two transportation lock screws and place them in the threads on the rear panel (Figure 2). -
Page 10: Imaging Door
The power switch on the rear panel must be switched on first. Imaging Door The self-opening and closing door provides access to the imaging tray for insertion and removal of VaxArray slides. The opening and closing of the imaging door is initiated within the software interface. -
Page 11: Hardware And Peripheral Connectors
“Mount 1” position with the A1 well of the slide located in the top left (Figure 3). Note that if you are performing a standard VaxArray analysis that provides a quantitative (μg/mL) result, the leftmost slide in Mount 1 should contain the standards comprising the calibration curve in slide wells A1 through H1. -
Page 12: Vaxarray Imaging And Analysis Software
VaxArray icon from the desktop. This software has been developed to allow a user to image and analyze VaxArray slides. Settings for the imaging operation, such as focus position and exposure time, are managed through the software interface. The user can enter and store reagent concentrations, lot numbers, and other assay information for each analysis. -
Page 13: Imaging And Analyzing A Vaxarray Experiment
Imaging and Analyzing a VaxArray Experiment Notes: The VaxArray Imaging and Analysis System is compatible with all commercially-available VaxArray assays. This manual will use the VaxArray Influenza Seasonal Hemagglutinin Potency Assay v1.2 to illustrate the use of the system. Standard Workflow... -
Page 14: Start New Experiment
Figure 5: VaxArray Software Home Screen. Select New Experiment on the home screen. A pop-up will appear that allows the user to select the VaxArray assay to be analyzed (Figure 6). Additionally, the user may select to analyze the assay in Raw Analysis Mode, which provides results as RFU (relative fluorescent unit) values instead of determining protein concentrations. -
Page 15: Setup Experiment
Edits to these variables are restricted to users with sufficient permissions. a. Analysis Methodology: Analysis with the VaxArray Imaging and Analysis Software can be performed using either a sequence of four point linear fits or a sequence of five point linear fits. - Page 16 (Figure 9). The slide(s) must be clicked on and the Green Check selected in order to proceed to further operations. Figure 9: Sample, Reagent & Slide Information. Page 16 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004...
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Page 17: Preview & Image
E. Enter Standard Concentrations: The table at the bottom of the Setup Experiment view records the concentrations of the protein standards (μg/mL) used for the calibration curve. During the VaxArray assay procedure, these standards are processed in Column 1 of the slide. The user must enter concentrations that match their specific experiment. - Page 18 Enhanced Image Figure 11: Preview. C. Image and Analyze VaxArray Experiment: On the Preview & Imaging view, click the Play button (right arrowhead within double circle) to initiate imaging. As the individual wells are imaged, they will appear in the composite to the right. Imaging progress is also indicated by the expanding arc around the imaging circle.
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Page 19: Review Calibration Curves
The Calibration Curves view generates a graph for each detection antibody to assess the general reactivity of the antibody with the proteins contained within the standard (Figure 13). This screen will not be generated in Raw Analysis Mode. Page 19 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004... -
Page 20: Review Results Summary
The Results Summary view provides a table of results for each sample and array antibody (Figure 14). Standard analysis will provide results in μg/mL units while Raw Analysis Mode will provide RFU (relative fluorescence unit) values. Page 20 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004... - Page 21 Similarly, poor regression among the points in the calibration curve reduces confidence in the curve. An R Page 21 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004...
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Page 22: Results Worksheet
To generate a formatted report of the experiment, click on the Report icon (highlighted in Figure 16) on the bottom bar. This will automatically open the report as a pdf file. Page 22 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004... - Page 23 Figure 16: Generate a Report. Page 23 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004...
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Page 24: Opening Previously Run Experiments
E. Delete Images: A user with sufficient permissions can delete the raw images associated with an individual experiment. This is intended to help manage hard drive space. Once the Images for a Page 24 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004... - Page 25 This record shows times and data as well as user names for specific events corresponding to that experiment. In addition, this log will contain any annotations recorded by users of the system. Page 25 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004...
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Page 26: Accessing Vaxarray Imaging And Analysis System Settings & Information
B. Adjust Focus: Instrument focus must be checked upon receiving an instrument and after moving the instrument. The focus position of the VaxArray Imaging and Analysis System is stable during routine use, but periodic focus checks should be included as part of standard laboratory operations. - Page 27 If the final optimized settings are different by 0.3 (mm) or larger, contact InDevR. xiv. When all three arrays have been focused, select the Green Check to complete the adjustment.
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Page 28: Managing User Accounts
6. Type the user name you wish to add in the field labeled ‘Enter the object names to select’ 7. Select Check Names 8. Verify the user name is underlined 9. Select OK Page 28 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004... -
Page 29: Changing Administrator Privileges
VaxArray permissions easier, you can alternatively create your own groups that batch several types of VaxArray groups together. For instance, you could create a group called VaxArrayUsers, and add to it the groups VaxArrayOperators, VaxArraySetupExperiment and VaxArrayRunExperiment. Then any users added to VaxArrayUsers would be allowed to run the software, create experiments and run them. -
Page 30: Recommended Groups
This user will have access to all of the above functions but will also have permission to mark the results of an experiment as Reviewed. Add these users to the following groups: VaxArrayOperators, VaxArraySetupExperiment, VaxArrayRunExperiment, VaxArrayModifyExperiment, VaxArrayAnnotateRecords, VaxArrayDeleteRecords, VaxArrayAdjustFocus, VaxArrayReviewers, VaxArrayChangeAnalysisVariables, VaxArrayReprocess Page 30 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004... -
Page 31: Troubleshooting, Cleaning, And Service
Troubleshooting, Cleaning, and Service Failure to Find an Array The VaxArray Imaging and Analysis Software automatically finds the antibody spots in the arrays and uses the spot locations to determine signal intensities. Occasionally, the antibody spots are not automatically located within an array. -
Page 32: S Hipping
G. Repack the instrument into the original packaging in the same way it was delivered. H. If returning the instrument to InDevR, fill out the RMA (contact InDevR for this form). Proper Disposal of the Instrument You must dispose of the VaxArray Imaging and Analysis System properly according to local laws and regulations. -
Page 33: Trademarks
Trademarks Windows and Windows 7 are registered trademarks of Microsoft Corporation in the United States and other countries. VaxArray is a registered trademark of InDevR. Specifications Imaging System: Resolution on the sample 6.7 μm/Pixel Camera pixel resolution 1.3 Mpixel /Emission... - Page 34 2 x 2 GByte DDR3 Hard Disk 250 GByte or larger Interfaces 4x USB2 (4 internal) VGA Monitor output, PS/2 for keyboard and mouse RS-232 Serial 1000 Base-T Ethernet Page 34 VaxArray® Imaging and Analysis System Operation Manual CF-0159 R004...