Mimosa Pro Manuel utilisateur

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

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.

Caution

Use of controls or adjustments or performance of procedures other than

those speciﬁed herein may result in hazardous radiation exposure.

Covered by one or more of the following US patents and foreign equivalents:

●WO 2018/035612 A1

Contact

MIMOSA Diagnostics Inc.

2 Toronto Street, Unit 340

Toronto, Ontario, CANADA

M5B 2C5

mimosadiagnostics.com

Table Of Contents

Table Of Contents 3

Abbreviations 6

Introduction 7

Overview 7

Device Description 7

Figure 1: Major Components of the MIMOSA Pro device 9

Figure 2: Device connection ports 9

Indications/Intended Use 10

Contact 10

Safety 10

Contraindications 10

Essential Performance 10

Warnings and Foreseeable Misuse 10

Precautions 12

Preparation 14

Charging the Device 14

Preparing the Tissue Site 14

Cleaning the Device 14

Setting up the Device 14

Status LED 15

MIMOSA Pro App 16

Setup Wi-Fi / Login Screen 16

Figure 3: Login screen of the App 16

Provisioning a Device 16

Creating a New Patient 17

Figure 4: Patient List Screen 18

Figure 5: Patient Creation Screen 18

Creating a New Visit 18

Figure 6a: Visit Selection Page 19

Figure 6b: Visit Selection Page 20

Figure 7: Study Template Selection 20

Figure 8: Study Capture Screen 21

Image Tags, Labels, and Study Templates 21

Creating Study Templates Ad-Hoc 21

Figure 9 - New Image Label Creation 23

Standard Image Capture 23

Figure 10: ‘Loading Camera’ Screen 24

Loading Camera Screen 25

Figure 11: Initial Image Capture Screen 25

Figure 12: Image Capture Ready State 26

Figure 13: Too Close State 26

Figure 14: Too Far State 27

Firmware Update 28

Image Quality Assessment 28

Image Capture Troubleshooting 29

Viewing previous visits 29

Figure 15: Full Screen Image View 30

Additional App Information 31

Settings 31

Figure 16: More Menu Button 32

Figure 17: Main Settings Page 32

Figure 18: About Settings Page 33

Change a Patient’s Name 33

MIMOSA Pro Battery Information 33

Powering Down 34

Figure 19 - Powering off the device 34

Device Reset Procedure 35

Disposal 35

RMA 35

Other Troubleshooting 36

Figure 20: Refresh Camera View 38

Figure 21: LED Failure Error Screen 38

MIMOSA Pro Device Speciﬁcations 39

Table 2: MIMOSA Pro Device Characteristics 39

Table 3: Device Battery Characteristics 41

Table 4: Processing Unit Characteristics 41

Table 5: LED Characteristics 42

Figure 22a: Oximetry Colour Scale 42

Figure 22b: Thermal Colour Scale 42

Table 6: Label Symbols Description 43

MIMOSA Pro Web Portal Navigation (Health Care Practitioner - HCP) 44

Accessing the Web Portal 44

Figure 23: Login Page 44

Patients List Page 45

Figure 24: Patient List Page 45

Chart Page 47

Figure 25: Patient Chart Page 47

Full Screen Analysis Page 49

Figure 26: Full Screen Image Page 49

Comparison Page 51

Figure 27: Visit Comparison Page 51

Report Generator Page 53

Figure 28 - Report Generator Page 53

Web Portal Admin Controls 54

Figure 29 - Admin Patients Sidebar 54

Figure 30 - Admin Portal 55

Create a New User 55

Figure 31 - User Creation Dialog 56

Delete an Existing User 56

Figure 32 - Delete User Dialog 57

Lock/Unlock a User Account 57

Reset User Password 57

Figure 33 - Reset Password Dialog 58

Device Provisioning (Web Portal) 58

Figure 34 - Device Provisioning Controls 59

Web Portal Tag Manager 59

Figure 35 - Tag Manager 60

Tag Manager 60

Template Manager 60

Figure 36 - Template Manager 61

Figure 37 - Template Editor 62

Figure 38 - Adding new labels to a template 62

Additional MIMOSA Pro Web Portal Information 63

Electro-Mechanical Testing and Compliance 63

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

●MIMOSA -- Multispectral Mobile Tissue Assessment

●MR -- Magnetic Resonance

●StO2 --Skeletal Muscle oxygen saturation

●UVC -- Universal Serial Bus Video Class (connection port/cable)

●vis-NIR -- Visible to near infrared section of the electromagnetic

spectrum

Introduction

Overview

The MIMOSA Pro is a non-contact tissue monitoring device which

non-invasively illuminates and captures images of a target volume of

superﬁcial tissue to allow for standardized image capture and estimation of

temperature and tissue oxygen saturation. 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,

troubleshooting tips, as well as details on how to use the accompanying

MIMOSA Web Portal.

Device Description

The MIMOSA Pro device is an all-in one portable, battery-powered,

non-contact medical device.

The device uses an array of sensors to capture tissue data without patient

contact. The module comprises:

●A processing, interface, and display unit

●A ring consisting of six LED-pairs, where each pair illuminates at distinct

vis-NIR wavelengths

●A CMOS camera unit, located at the center of the LED ring

●A Time-of-Flight distance-ﬁnding sensor

●A diffusing element covering the LED/CCD system for protection and

homogeneous illumination

●Firmware, circuitry and a battery pack that is encapsulated within the

device hardcover

●Integrated Thermal Camera

The device is restricted to running custom MIMOSA Diagnostics software (The

MIMOSA Pro App). Major interface functions include:

●Real-time image stream

●User-triggered image capture

●Thermal heat map display, including the display of the temperature

values via touch-interface

●Oximetry colour map display, including the display of StO2 values via

touch-interface

●Storage and display of both image and form data

The MIMOSA App provides preview-guided, user-triggered capture of a

region of tissue and displays the calculated thermal distribution and tissue

oxygen saturation of the imaged area. The distributions are displayed on the

device screen as “heatmaps”. The user can select a speciﬁc point on the heat

maps to view the estimated temperature or StO2 value for the selected point.

Once the user has completed a capture, the captured data is stored in a

secure database, and if an internet connection is available, uploaded to the

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;

●The MIMOSA Pro device.

●Device charging cable.

●Device wall charger.

●A QR code card which links to the Operator’s Manual.

●A Quick start user reference guide

Figures 1&2display the major components of the MIMOSA Pro device as well

as location of the charging port.

Figure 1: Major Components of the MIMOSA Pro device

Figure 2: Device connection ports

Indications/Intended Use

The MIMOSA Pro is intended to non-invasively estimate the spatial

distribution of percent oxygen saturation (StO2) in a volume of tissue. This is

performed in medical environments including physician ofﬁces, hospitals,

ambulatory care and Emergency Medical Services.

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

Upon reading the manual, if there are any issues or concerns during the

operation of the device, please email the MIMOSA Diagnostics support team

at:

[email protected]

Safety

Contraindications

There are no known contraindications for the use of the MIMOSA Pro device.

Essential Performance

The MIMOSA Pro device has no essential performance.

Warnings and Foreseeable Misuse

Warnings alert the operator towards potentially serious outcomes to either

the person being monitored or the device operator.

●The MIMOSA Pro device should be protected from unauthorized use.

●Routinely inspect the LED ring (Fig. 1), charging port (Fig. 2), and cable

for visible damage before each use. Ensure that the device is off when

inspecting.

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