Barco Demetra User manual

ENABLING BRIGHT OUTCOMES
BDEM-01
User Guide
Barco Demetra

Registered office: Barco NV
President Kennedypark 35, 8500 Kortrijk, Belgium
www.barco.com/en/support
www.barco.com
Barco NV
Beneluxpark 21, 8500 Kortrijk, Belgium
www.barco.com/en/support
www.barco.com

3K5902200 /07 Barco Demetra
1 Welcome!.......................................................................................................................................................................................................... 5
1.1 Use specification ................................................................................................................................................................................6
1.2 About the Demetra solution..........................................................................................................................................................7
1.3 What’s in the box................................................................................................................................................................................7
1.4 Demetra Scope ...................................................................................................................................................................................8
1.5 Demetra Web Application .............................................................................................................................................................9
1.6 Analytics Toolkit ..................................................................................................................................................................................9
2 Installation and configuration..................................................................................................................................................... 11
2.1 Minimum system requirements...............................................................................................................................................12
2.2 Setup of Demetra Web Application.......................................................................................................................................12
2.2.1 Activation .........................................................................................................................................................................12
2.2.2 Configuration (admin)...............................................................................................................................................13
2.2.3 Configuration (user)...................................................................................................................................................14
2.2.4 Configuration (guest user) .....................................................................................................................................14
2.2.5 Settings (admin)...........................................................................................................................................................15
2.2.6 Settings (user) ..............................................................................................................................................................16
2.2.7 About Demetra .............................................................................................................................................................17
2.3 Installation of Demetra Scope..................................................................................................................................................17
2.3.1 Installation of the grip / battery pack.................................................................................................................17
2.3.2 Removal of the grip / battery pack.....................................................................................................................18
2.3.3 Installation of the non-contact cone..................................................................................................................19
2.3.4 Charging the Demetra Scope...............................................................................................................................20
2.4 Setup of Demetra Scope ............................................................................................................................................................20
2.4.1 Configuration .................................................................................................................................................................20
2.4.2 Status bar ........................................................................................................................................................................21
2.5 When the Demetra subscription is terminated ...............................................................................................................22
3 Operation with the Demetra Scope......................................................................................................................................23
3.1 Start the Demetra Scope ............................................................................................................................................................24
3.2 Basic workflow..................................................................................................................................................................................24
3.3 Live video preview..........................................................................................................................................................................25
3.4 Image detail screen .......................................................................................................................................................................26
3.5 Localize (on clinical overview).................................................................................................................................................27
3.6 User entry of diagnosis and management strategy .....................................................................................................27
Table of contents

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4 Operation with the Demetra Web Application............................................................................................................29
4.1 Open the Demetra Web Application.....................................................................................................................................30
4.2 Main menu .......................................................................................................................................................................................... 30
4.3 Patient detail screen......................................................................................................................................................................31
4.4 Consultations screen ....................................................................................................................................................................33
4.5 Image detail screen .......................................................................................................................................................................33
4.6 User entry of diagnosis and management strategy .....................................................................................................36
4.7 Reports .................................................................................................................................................................................................36
4.8 Sharing patient data (Collaboration) ....................................................................................................................................37
5 Troubleshooting ......................................................................................................................................................................................39
5.1 Troubleshooting instructions.....................................................................................................................................................40
6 Repacking instructions.....................................................................................................................................................................43
6.1 Repacking overview ......................................................................................................................................................................44
7 Cleaning and disinfection ..............................................................................................................................................................47
7.1 Instructions .........................................................................................................................................................................................48
8 Important information.........................................................................................................................................................................49
8.1 Safety information...........................................................................................................................................................................50
8.2 Environmental information.........................................................................................................................................................52
8.3 Regulatory compliance information......................................................................................................................................52
8.3.1 EU statement.................................................................................................................................................................52
8.3.2 FCC statement .............................................................................................................................................................53
8.3.3 Industry Canada statement - Avis d'industrie Canada...........................................................................53
8.3.4 General information ...................................................................................................................................................54
8.4 Integration of Demetra in IT networks .................................................................................................................................54
8.5 EMC notice ......................................................................................................................................................................................... 56
8.6 Explanation of symbols................................................................................................................................................................58
8.7 Explanation of icons ......................................................................................................................................................................61
8.8 Legal disclaimer...............................................................................................................................................................................64
8.9 Technical specifications...............................................................................................................................................................64

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1.1 Use specification ............................................................................................................................6
1.2 About the Demetra solution .............................................................................................................7
1.3 What’s in the box ............................................................................................................................7
1.4 Demetra Scope ..............................................................................................................................8
1.5 Demetra Web Application................................................................................................................9
1.6 Analytics Toolkit..............................................................................................................................9
Refer to www.barco.com/support/demetra/docs for the latest version and translations of this User
Guide.
Contact the Barco helpdesk via www.barco.com/support/demetra.
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1.1 Use specification
Indications for Use
The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquires multispectral and
white light dermoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed
and reviewed by trained medical practitioners.
Intended usage environment
The device is intended to be used in a normal working environment of medical practitioners examining skin
conditions. A number of considerations should be taken into account:
•It should be avoided to operate the device with wet hands, in order to prevent dropping the device.
•The touch display of the device can be operated wearing gloves. The following types of gloves were tested
to work with the touch display and scroll touchpad:
- Hartmann Peha-Soft Nitrile Powderfree
- Hartmann Peha-Soft Vinyl Powderfree
- Hartmann Peha-Soft Latex Powderfree
•The Demetra solution requires a WiFi connection.
Caution (USA): Federal law (United States of America) restricts this device to sale by or on the order of a
licensed healthcare practitioner (Details & exemptions are in the Code of Federal Regulations Title 21, 801
Part D).
Intended patient population
The device is intended to be used on all patients who consult with a physician or other healthcare professional
regarding a certain skin condition.
Intended part of the body or type of tissue applied to or interacted with
The device can be used on the following body parts:
•Skin
•Nails
•Hair
The device should not be used:
•For lesions in the eyes. The device should not be pointed towards the eyes. It is recommended that
patients close their eyes during examination near their eyes.
•In contact with breached or compromised skin surfaces.
Expected clinical benefits
Demetra BDEM-01 allows an easy, fast and accurate skin lesion follow-up.
Contra-Indications
Not for lesions in the eyes.
Intended users
The intended users for the Demetra solution are trained medical practitioners, whether they are active in a
private practice, hospital or clinic.
Operating principle
The Demetra solution consists of a hardware device and a stand-alone software application.
The hardware device is a portable, battery powered medical device for acquiring and visualizing images of the
skin. The device acquires multispectral optical dermoscopic images in a contact mode (device in contact with
the skin). In addition the device can also acquire a clinical close-up image, when it is held at up to 10 to 15 cm
from the skin, and a clinical overview image when it is held at approximately 35 to 55 cm from the skin.
The device uploads all images to cloud storage.
The stand-alone software application is cloud software with a related web application. This cloud software can
visualize images and related data and can generate consultation reports.
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1.2 About the Demetra solution
General
The Demetra solution is a platform for skin imaging. It consists of the following main parts:
1. Demetra Scope for capturing images and optimizing the imaging and documentation workflow.
2. Wireless and secure transfer of images and metadata from the device memory to the cloud, via WiFi, for
storage in the cloud.
3. Secure Demetra Web Application for patient record and image library management and workflow tools.
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Image 1–1
Features
•Battery capacity of 3 –6 hours continuous operation
•Rechargeable and replaceable grip / battery pack
•Demetra Web Application for viewing captured images and photographs
•Primary camera for multispectral dermoscopic images and clinical close-up photographs
•Secondary camera for clinical overview and close-up photographs
•Polarized and non-polarized illumination
•Touch screen with full HD resolution
•Autofocus
1.3 What’s in the box
Contents
•Demetra Scope head
•Rechargeable grip / battery pack
•Battery charging station
•Non-contact cone
•Adapter and plugs
•Quick Start Guide
•User Guide
Keep your original packaging. It is the ideal protection during transport of the Demetra Scope and is
required to be used in case of service/return.
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1.4 Demetra Scope
Components
The Demetra Scope is a handheld, wireless medical device, purpose-built for dermoscopic and clinical
imaging. The Demetra Scope offers the most detailed images, an easy-clean design and smart mechanics.
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Image 1–2
1. Touch display
2. Left scroll touchpad
3. Main button
4. Right scroll touchpad
5. Rechargeable grip / battery pack
6. Battery charging station
7. LED indicator
- Off: Default behavior/charged batteries (>20%)
- Steady orange: Batteries low (≤20%)
- Slow blinking green: Batteries charging (when the device is placed in the battery charging station)
- Steady green: Batteries fully charged (when the device is placed in the battery charging station)
8. On/Off button
9. Head with primary camera for dermoscopic imaging and clinical close-up photographs (up to 5–10 cm from
the skin)
10.Secondary camera for clinical overview photographs and clinical close-up photographs (more than 10 cm
from the skin)
11. Non-contact cone
12.Locking ring
The power supply is specified as a part of the Demetra Scope. Use only the delivered power supply
for charging your device.
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1.5 Demetra Web Application
Overview
The Demetra Web Application is an on-line application which allows the user to view and manage all patient
information and images/photographs captured with the Demetra Scope. The Demetra Web Application offers
a lot of functionalities (see “Operation with the Demetra Web Application”, page 29, for more information).
About Demetra
The Demetra Web Application includes an About Demetra page (see “About Demetra”, page 17, for more
information), which shows medical device information for BDEM-01 and related medical devices, such as
Analytics Toolkit (see “Analytics Toolkit”, page 9, for more information).
1.6 Analytics Toolkit
Add-on tools
The Analytics Toolkit is a separate medical device, that can only be used in combination with BDEM-01. It is a
software application that consists of tools for analyzing white light and/or multispectral dermoscopic images
captured with the Demetra Scope. Those tools allow to clearly visualize specific skin structures, such as
primarily pigment distribution and blood vessels, or generate other characteristics of skin lesions. Each of
those tools can be used to aid a medically trained practitioner in taking a clinical decision. The outputs of the
Analytics Toolkit can be consulted in the Demetra Web Application or on the Demetra Scope.
Analytics tools are included in selected Demetra main subscriptions and/or available as add-on subscriptions.
They cannot be purchased or used as standalone subscriptions. More details on the available subscriptions
can be found on www.barco.com/demetra.
Check the Analytics Toolkit User Guide on www.barco.com/support/demetra/docs for more details
on how to consult the outputs of the Analytics Toolkit in the Demetra Web Application.
The Analytics Toolkit is subject to medical device clearance. Not all tools are currently available in
all markets.
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Welcome!