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Mimosa Pro Operator's Manual

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MIMOSA Pro
Operator's Manual
MIMOSA Diagnostics Inc.
366 Adelaide St East, Unit 434
Toronto, Ontario, CANADA
M5A 3X9
mimosadiagnostics.com
Operator's Manual Version 1.4

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  • Page 1 MIMOSA Pro Operator’s Manual MIMOSA Diagnostics Inc. 366 Adelaide St East, Unit 434 Toronto, Ontario, CANADA M5A 3X9 mimosadiagnostics.com Operator’s Manual Version 1.4...

  • Page 2: Table Of Contents

    The information in this manual has been carefully checked and is believed to be accurate. In the interest of continued product development, MIMOSA Diagnostics Inc. reserves the right to make changes and improvements to this manual and the products it describes at any time, without notice or obligation.

  • Page 3: Table Of Contents

    Table Of Contents Table Of Contents Abbreviations Introduction Overview Device Description Figure 1: Major Components of the MIMOSA Pro device Figure 2: Device connection ports Indications/Intended Use Contact Safety Contraindications Essential Performance Warnings and Foreseeable Misuse Precautions Preparation Charging the Device...
  • Page 4 Other Troubleshooting Figure 20: Refresh Camera View Figure 21: LED Failure Error Screen MIMOSA Pro Device Specifications Table 2: MIMOSA Pro Device Characteristics Table 3: Device Battery Characteristics Table 4: Processing Unit Characteristics Table 5: LED Characteristics Figure 22a: Oximetry Colour Scale...
  • Page 5 MIMOSA Pro Web Portal Navigation (Health Care Practitioner - HCP) Accessing the Web Portal Login Page Figure 23: Login Page Patients List Page Figure 24: Patient List Page Chart Page Figure 25: Patient Chart Page Full Screen Analysis Page Figure 26: Full Screen Image Page...

  • Page 6: Abbreviations

    ● App -- Software application ● CCD -- Charge-coupled device ● Check In -- Consists of images and textual data input ● Device -- The MIMOSA Pro Device ● HCP -- Health Care Practitioner ● LED -- Light emitting diode ●...

  • Page 7: Introduction

    The Pro includes an interface that is designed for convenient and rapid image capture. This manual will provide the reader with further details on the MIMOSA Pro hardware and software specifications, the intended use of the device, safety and warning notifications, system setup, operations and maintenance,...
  • Page 8 MIMOSA web portal for remote viewing. Each MIMOSA Pro is delivered as part of a MIMOSA Pro kit, this kit is packaged in a rugged hard case, and includes the following;...
  • Page 9 Figure 1: Major Components of the MIMOSA Pro device Figure 2: Device connection ports...

  • Page 10: Indications/Intended Use

    The MIMOSA Pro is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The MIMOSA Pro is intended as an adjunctive decision aid and should not be used to replace good clinical diagnostic practices. Contact...
  • Page 11 ● Portable RF communications equipment, such as antennas/antenna cables, should be used no closer than 30 cm (12 inches) from any part of the MIMOSA Pro. Failure to do so may result in a degraded performance of the device. ● The emissions characteristics of the MIMOSA Pro device make it suitable for use in industrial areas, hospitals and other CISPR 11 class A environments.

  • Page 12: Precautions

    ● Device is used to image hairy or tattooed regions - If the MIMOSA Pro device is used to image particularly hairy or tattooed regions of the body, the StO2 value calculated may be inaccurate.

  • Page 13: Preparation

    Preparation Charging the Device 1. The device should be charged daily or as required. 2. Plug the included charger into the wall outlet. Connect one end of the USB C cable to the port on the charger and other end to the charging port on the device - refer to Figure 2 for the location of the charging...

  • Page 14: Status Led

    2) will indicate ‘Green’. Ignoring any of these steps may cause the device to generate inaccurate readings. If you are experiencing issues after following all steps in this section, please contact the MIMOSA Diagnostics support team. support@mimosadiagnostics.com Status LED On the underside of the device (See...

  • Page 15: Mimosa Pro App

    Figure 3: Login screen of the App Provisioning a Device 1. In addition to logging into the MIMOSA Pro device with an individual username, it is possible to provision a device for an organization if this has been enabled by your IT admin.

  • Page 16: Creating A New Patient

    2. This provides a means of using the device without requiring individual users to login. 3. To provision a new device to your organization : a. Login to the device with an admin user. b. Swipe right from the patients screen to show the navigation pane and select ‘Settings’.

  • Page 17: Creating A New Visit

    Figure 4: Patient List Screen Figure 5: Patient Creation Screen Creating a New Visit 1. From the patient selection screen (Figure 4), select the desired patient. 2. Select the "No Visits Found" button. Refer to Figure...
  • Page 18 Note: Figure 6a will only appear if this is your first visit. If this is not your first visit, you will see Figure 3. Select an existing template for the patient or create a new one (See Image Tags, Labels, and Study Templates).
  • Page 19 Figure 6b: Visit Selection Page Figure 7: Study Template Selection...

  • Page 20: Image Tags, Labels, And Study Templates

    Creating Study Templates Ad-Hoc 1. New study templates can either be created on the MIMOSA Pro device or via the MIMOSA Pro web portal (see Template Manager).
  • Page 21 a. When a new patient is created, the user will be prompted by the device to select an existing study template or create a new one (See Figure b. Select ‘Create Your Own’. c. Tap on the ‘+’ symbol to add the first image label for the new template.

  • Page 22: Standard Image Capture

    Figure 9 - New Image Label Creation Standard Image Capture 1. Ensure that you have followed the instructions in Preparing the Tissue Site before starting the image capture. 2. Ensure the image target is not resting on a surface as this can affect the image quality.
  • Page 23 pencil icon underneath the image to be re-labelled (See Figure 8). The image label editing dialog will be displayed (See Figure Note: Care should be taken when renaming images to avoid mis-identifying the subject of a capture. 8. To recapture a previously captured image, tap on the image in the study template, and then tap the purple camera icon in the bottom right of the display.

  • Page 24: Loading Camera Screen

    ● Use a pointed object (such a sim removal tool) to press the reset switch located on the underside of the device. ● Power the device off and back on. If this error persists, even through a device reboot, please contact MIMOSA support. Figure 11: Initial Image Capture Screen...
  • Page 25 Figure 12: Image Capture Ready State Figure 13: Too Close State...
  • Page 26 Figure 14: Too Far State...

  • Page 27: Firmware Update

    Image Quality Assessment A MIMOSA image capture consists of 9 images that are all captured in a few hundred milliseconds. To ensure that all of these images are successfully acquired, the resulting image set is run through an image quality pipeline.

  • Page 28: Image Capture Troubleshooting

    Image Capture Troubleshooting Case 1: Too Close. See Figure 13 ● Simply move the Device farther away from the tissue you are trying to image. ● As you move away, the indicator should move into the green ‘Good’ region on the distance finder, See Figure Case 2: Too Far.
  • Page 29 Figure 15: Full Screen Image View...

  • Page 30: Additional App Information Settings

    Check Pressing this will check the server for any Software Updates Updates Contact This will display MIMOSA Diagnostic’s support email Information address. Screen If your IT team hasn’t set a screen timeout, this will allow Timeout you to set one yourself.
  • Page 31 Figure 16: More Menu Button Figure 17: Main Settings Page...

  • Page 32: Change A Patient's Name

    3. Enter a new name for the patient (Note: The patient name cannot contain special characters). 4. Press ‘SAVE’ to confirm the change to the patient name. MIMOSA Pro Battery Information 1. The device’s battery level can be seen by dragging down the tool bar from the top of the screen.

  • Page 33: Powering Down

    Powering Down 1. To turn off the device, simultaneously press and hold the ‘Power’ and ‘Volume up’ buttons on the side of the device. (See Figure 19). 2. A menu will pop-up, select “Power off” from that menu. Figure 19 - Powering off the device...

  • Page 34: Device Reset Procedure

    Figure 2) illuminates green. Disposal If you are looking to dispose of the MIMOSA Pro Device, please contact MIMOSA Diagnostics support team, support@mimosadiagnostics.com, to determine what can work best for you. If you need to return your device for repairs or any other reason, contact MIMOSA directly at: support@mimosadiagnostics.com...

  • Page 35: Other Troubleshooting

    If this is your first time logging into this device, ensure it is connected to the internet (via Wi-Fi or mobile data). If the problem persists, contact MIMOSA for support. Image Capture Image preview Check the device battery is not screen is black or low.
  • Page 36 *Where X is a value 1 to 6, e.g. Figure “Device End of Life Contact MIMOSA Diagnostics at Notice - The device support@mimosadiagnostics.com and arrange a replacement or has reached its end recalibration of your device.
  • Page 37 Figure 20: Refresh Camera View Figure 21: LED Failure Error Screen...

  • Page 38: Mimosa Pro Device Specifications

    Temperature: 0°C to 40°C Conditions Humidity: 30 to 60% RH Atmospheric Pressure: 700hPa to 1060hPa Factory The device shall be sent back to MIMOSA Maintenance Diagnostics every year from the date of first use for Interval inspection of device performance including pulse...
  • Page 39 < 400 * 2000 1200 < 1790 * 5000 1200 < 700 * 3000 1200 The entries denoted with * are listed by the manufacturer as the output at the maximum rated pulsed current. This is greater than the operational current of our LEDs (column 4).
  • Page 40 Table 3: Device Battery Characteristics Type Rechargeable Li-polymer Manufacturer GlobTek Inc. Ratings 3.7 V, 1200 mAh, 4.44 Wh Charge Temperature 0 - 40 ºC Standards Compliance IEC 62133, UN 38.3 Charger Specifications Charges via internal USB connection 5VDC 0.5A Table 4: Processing Unit Characteristics Battery Type Non-removable Li-Po 4410 mAh battery...
  • Page 41 Table 5: LED Characteristics LED Pair # Peak Wavelength (nm) Full Width Half Max (nm) 620.1 ± 0.7 13.6 ± 0.2 629.9 ± 0.1 12.8 ± 2.9 703.5 ± 0.7 16.2 ± 1.2 810.0 ± 1.6 19.2 ± 0.7 879.4 ± 0.2 11.1 ±...
  • Page 42 Table 6: Label Symbols Description Symbol Warning Description Read the manual before use Fragile, handle with care Batteries present inside May cause fire if damaged Light emission hazard. Use appropriate shielding or eye protection...

  • Page 43: Mimosa Pro Web Portal Navigation (Health Care Practitioner - Hcp)

    To access the web portal, use a Google Chrome browser to navigate to https://access.mimosadiagnostics.com. Login Page Upon entering the above, you will be greeted with the login page. Enter the same credentials used for the MIMOSA app and then click ‘Sign In’ to login to the web portal. Figure 23: Login Page...

  • Page 44: Patients List Page

    Patients List Page Figure 24: Patient List Page Upon logging in, you will be greeted with a list of all of your patients. The page is divided into two sections outlined below. 1. Sidebar Mainly used for navigation and system level actions like exporting and logging out, this persists through all pages on the web portal.
  • Page 45 This search bar allows you to filter the list of displayed patients. Simply enter the name of the patient you are looking for to filter on that name. c. New Patient button This button allows for creation of a new patient; enter a new patient name, select the patient’s Healthcare Provider (HCP) from the dropdown, and click ‘Save’...

  • Page 46: Chart Page

    Chart Page Figure 25: Patient Chart Page Upon clicking a patient in the ‘Patients List’, you will be presented with the selected patient’s ‘Chart Page’. The Chart Page consists of the following sections. 1. Sidebar The sidebar has the same high level navigation and system level actions as the ‘Patients List’...
  • Page 47 This shows the oximetry image for each capture taken in the currently selected study. The images can be clicked to view the ‘Full Analysis Page’ for that capture. c. Patient Information This displays the current patient name, as well as a summary of the risk associated with any completed patient surveys.

  • Page 48: Full Screen Analysis Page

    Full Screen Analysis Page Figure 26: Full Screen Image Page Upon clicking an image in the Chart Page you will be presented with that image’s full screen analysis page. This page includes three images (Digital, Thermal, Oximetry) as well as two trend graphs for Thermal and Oximetry trends.
  • Page 49 b. Longitudinal Trending Information (Oximetry) After clicking on the Oximetry Image, the graph will load the longitudinal Oximetry data for the selected point for all of the patient’s visits. Hovering over data points on the graph will give you some more information about that date’s information. c.

  • Page 50: Comparison Page

    Comparison Page Figure 27: Visit Comparison Page Upon selecting a visit to compare you will be greeted with the Comparison Page. This page contains images from the two visits you’re comparing, as well as a summary of question changes, and comparison graphs for Thermal and Oximetry data.
  • Page 51 Image Set Two works identically as Image Set One, the only difference is that Image Set Two contains the images for the visit you selected to compare. 3. Summary of Changed Questions Displays the questions that have changed between the two visits you’re comparing.

  • Page 52: Report Generator Page

    Report Generator Page The ‘Report Generator’ page provides you with the ability to generate a report from any captured study: 1. Complete any desired fields; the report generator allows for specification of the patient’s Chief Complaint, previous illness, and details about the location, size, and type of wound. 2.

  • Page 53: Web Portal Admin Controls

    Web Portal Admin Controls 1. Users with admin accounts gain access to an additional ‘admin portal’ in the MIMOSA Pro web portal. 2. The admin portal is accessible through a new button on the sidebar, only accessible by admin users -- Figure 3.

  • Page 54: Create A New User

    Figure 30 - Admin Portal Admin Portal Controls 1. Add User button. 2. Users a. User lock status indicator. b. Lock/Unlock button. c. Password reset button. d. Delete user button. Create a New User 1. To create a new user for your site access the admin portal and select ‘Add User’...

  • Page 55: Delete An Existing User

    Figure 31 - User Creation Dialog Delete an Existing User 1. To delete an existing user, find the user in the user list on the admin portal and click the ‘trash’ icon in the same row as the user to be deleted.

  • Page 56: Lock/Unlock A User Account

    Lock/Unlock a User Account 1. User accounts can be locked by admins. Locking an account will prevent the owner of that account from logging into the MIMOSA Pro application and web portal. 2. If a user account is locked, the lock symbol to the left of the username in the admin portal will be ‘closed’...

  • Page 57: Device Provisioning (Web Portal)

    Figure 33 - Reset Password Dialog Device Provisioning (Web Portal) 1. In addition to logging into the MIMOSA Pro device with an individual username, it is possible to provision a device for an organization. 2. This provides a means of using the device without requiring individual users to login.

  • Page 58: Web Portal Tag Manager

    Figure 34 - Device Provisioning Controls Web Portal Tag Manager In addition to the admin controls menu, admin users gain access to the tag manager page. The tag manager allows admin users to create custom tags for image orientations which will be captured frequently by the site users. A ‘tag’...

  • Page 59: Tag Manager

    Figure 35 - Tag Manager Tag Manager 1. To generate a new tag, first navigate to the Tag Manager page by clicking the ‘Tag Manager’ button in the navigation bar. 2. The Tag Manager page is displayed see Figure 3. Simply enter the text for the tag to be created and click ‘Add Tag’. 4.
  • Page 60 4. Click on the name of the new template to add new image labels to the template (see Figure 5. Click the ‘New Label’ button in the top right of the screen. A new dialog is displayed (see Figure 38). 6.
  • Page 61 Figure 37 - Template Editor Figure 38 - Adding new labels to a template...

  • Page 62: Additional Mimosa Pro Web Portal Information

    Additional MIMOSA Pro Web Portal Information 1. The MIMOSA Pro Web Portal was designed and developed to be used with the latest released version of Google Chrome. Using a browser other than the one listed above is not supported and could cause issues.

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