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.
Welcome! 1

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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.
1
2
3
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.
8
10
9
12
11
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!

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2.1 Minimum system requirements ......................................................................................................12
2.2 Setup of Demetra Web Application.................................................................................................12
2.3 Installation of Demetra Scope........................................................................................................17
2.4 Setup of Demetra Scope ...............................................................................................................20
2.5 When the Demetra subscription is terminated .................................................................................22
Installation and
configuration 2

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2.1 Minimum system requirements
Upload/download speed requirements
The Demetra Scope may be used offline after the initial setup, but a WiFi connection is required for data to be
synchronized to the Cloud. For an optimal user experience, we recommend the following bandwidth:
•Download speed: 30 Mb/s
•Upload speed: 15 Mb/s
The same requirements apply for using the Demetra Web Application.
Data will still be synchronized at lower upload and download speed, but the user experience will be
suboptimal.
A network connectivity test can be performed on the device via the Network settings menu (see “Setup of
Demetra Scope”, page 20).
Web browser
Demetra Web Application should be connected to the internet at all times. The following web browsers are
supported:
•Google Chrome (version 63 or higher)
•Mozilla Firefox (version 57 or higher)
•Microsoft Edge
Please make sure to have the latest updates of your web browser installed and to have an up-to-
date virus scanner running at all times.
Display resolution
For an adequate viewing experience, we recommend to use a display with a minimum resolution of 1920 x
1080 pixels. The displays from Barco’s clinical range are an excellent match when using Demetra Web
Application.
2.2 Setup of Demetra Web Application
2.2.1 Activation
User authentication
When you purchased a Demetra subscription, you will receive an onboarding email with temporary password.
Click the link in this email to register as admin.
As admin it is possible to add new users (see “Settings (admin)”, page 15). When a new user has been added,
he will also receive an onboarding email with temporary password. Click the link in this email to register as
user.
When you share a collaboration request with an email address not linked to a Demetra account (see “Sharing
patient data (Collaboration)”, page 37), a guest account will need to be registered with that email address in
order to access the request.
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Image 2–1
The web browser will open and a sign-in window will be shown. Fill in your email address as username and
the temporary password you received in the registration email. Click Sign in.
Image 2–2
A new window opens to set your password. Click Send to confirm.
You are then guided to the Demetra welcome screen. As an admin user, refer to “Configuration (admin)”, page
13 to start the configuration. As a regular user, refer to “Configuration (user)”, page 14.
2.2.2 Configuration (admin)
Admin
After user authentication as admin (see “Activation”, page 12), select the desired account language and click
Start configuration on the Demetra welcome screen.
1. Decide whether patient records will be shared among users in your organization or whether they will be
uniquely assigned to a specific user. Note that it is not possible to change this selection once configuration
is completed. Click Next and then confirm your choice.
2. Provide the address where the Demetra Scope(s) will be installed. Click Next to confirm.
3. Complete your personal information.
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4. Choose your personal device settings and authentication:
- Select your personal language and keyboard region. Those combined settings determine the layout of
the device keyboard.
- Set your personal device authentication (pin code or no authentication).
5. Carefully read the safety warnings and recommendations related to the usage of the Demetra Scope and
Demetra Web Application. Tick the checkbox I have read and understand the safety warnings and
recommendations and click Next to confirm.
6. An overview of the selected settings is shown. Tick the checkbox I have read the Barco product privacy
statement and the End User License Agreement. Indicate whether you agree to linking your product
feedback to your user identity. Click Submit to confirm.
Click Barco product privacy statement to open and read the Barco product privacy statement. It is
available at www.barco.com/about-barco/legal/privacy-policy/product-privacy-statement.
Click End User License Agreement to open and read the Demetra End User License Agreement.
The settings determined in steps 3-4 are personal user settings. To change any individual user's
settings, see Users under “Settings (admin)”, page 15 or “Settings (user)”, page 16. To change
general account settings (such as allowed device authentication methods, color scheme, account
language, etc.), see Account settings under “Settings (admin)”, page 15.
2.2.3 Configuration (user)
User
After user authentication (see “Activation”, page 12), select the desired language and click Start configuration
on the Demetra welcome screen.
1. In the personal information screen, fill in your first name, last name and telephone number and click Next to
confirm.
2. Adapt the settings as desired and click Next to confirm. The following settings can be adapted:
- Device authentication: Select your desired device authentication method (pin code or no
authentication), depending on the account settings (see “Settings (admin)”, page 15).
- Select your language and keyboard setting. Those combined settings determine the layout of the
device keyboard.
3. Carefully read the safety warnings and recommendations related to the usage of the Demetra Scope and
Demetra Web Application. Tick the checkbox I have read and understand the safety warnings and
recommendations and click Next to confirm.
4. An overview of the selected settings is shown. Tick the checkbox I have read the Barco product privacy
statement and the End User License Agreement. Indicate whether you agree to linking your product
feedback to your user identity. Click Submit to confirm. You are now all set as a user and are able to
operate the Demetra Scope.
Click Barco product privacy statement to open and read the Barco product privacy statement. It is
available at www.barco.com/about-barco/legal/privacy-policy/product-privacy-statement.
Click End User License Agreement to open and read the Demetra End User License Agreement.
These settings can be changed later on, see “Settings (user)”, page 16.
2.2.4 Configuration (guest user)
Guest user
After guest user authentication (see “Activation”, page 12), select the desired language and click Start
configuration on the Demetra welcome screen.
1. In the personal information screen, fill in your first name and last name and click Next to confirm.
2. Carefully read the recommendations related to the usage of the Demetra Web Application. Tick the
checkbox I have read and understand the recommendations and click Next to confirm.
3. An overview of the selected settings and completed information is shown. Tick the checkbox I have read
the Barco product privacy statement and the End User License Agreement. Indicate whether you consent
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to the use of your personal data for Demetra marketing purposes. Click Submit to confirm. You are now all
set as a guest user and have access to all collaboration requests shared with you.
2.2.5 Settings (admin)
Admin
When logged in as admin, click your name at the top of the screen in the Demetra Web Application and select
Admin settings. The following tabs are available under the Admin settings:
•Users
•Devices
•Account settings
Users
The first tab under the Admin settings is the Users screen:
Image 2–3
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This screen allows the admin to:
•Add users/admin. Enter their email address in a free user slot. Regular users (with access to patient
records) should be added in the Clinical Users category. Admin only users should be added in the Other
Users category. The new users will then receive an onboarding email with temporary password.
•Reassign users. Drag users from the Other Users category to the Clinical Users category to give them
access to patient records, or the other way around to remove their access to patient records. Click Move
user to confirm.
•Delete users. Click the Delete button next to the user's name and confirm.
•View and/or change the settings per individual user. Click the eye icon next to the user's name and change
the settings as desired, including enabling or disabling administration rights.
Devices
This second tab under the Admin settings shows the different Demetra Scopes that are linked to the customer
account (organization). Click on the specific Demetra Scope to view and edit the device information and time
zone.
Through this screen it is possible to perform device management tasks like (un) linking a specific Demetra
Scope to this customer account or managing WiFi certificates.
To add (link) a Demetra Scope
1. Select the tab Devices.
2. Perform the configuration of the Demetra Scope (see “Configuration”, page 20) to link a device to the
customer account.
To add WiFi certificates to a linked device
1. Select the tab Devices.
2. Open the device settings for a linked device.
3. Click Add a network certificate to upload individual x.509 certificates (client or CA certificate with .crt
extension) or an entire PKCS#12 certificate chain (.p12 or .pfx extension).
4. Set up the network connection on your onboarded Demetra Scope using the uploaded WiFi certificates
(see “Configuration”, page 20).
Account settings
The Account settings tab under the Admin settings allows the admin to:
1. Change the device authentication methods (pin code or no authentication) allowed to log in on the
Demetra Scope. Depending on the allowed authentication method(s), each user can set his personal
authentication method (see “Configuration (user)”, page 14).
2. Change the color scheme, language and keyboard region of the account. The combined language and
keyboard region settings determine the layout of the device keyboard.
3. Consult the permission model. This setting can no longer be changed after initial configuration is
completed (see “Configuration (admin)”, page 13, for more information).
4. Change the account privacy settings (in case the permission model is set such that all users have access
to all patient records).
2.2.6 Settings (user)
User
When logged in as a regular and/or admin user, click your name at the top of the screen in the Demetra Web
Application and select User settings. Here you can:
•Edit your personal information
•Edit your user interface settings (language, date and time format, number format, etc.), device
authentication method (including changing your pin code) and privacy settings
•Consult your account information, i.e., your subscription license and add-ons (for non-admin users only; for
admin users, this information is available in the admin settings (see “Settings (admin)”, page 15).
Data export
Click your name at the top of the screen in the Demetra Web Application and select User settings.
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On the Data export screen, you can export all user data and all patient data you have access to. You can
export all data in your account, or select a period or start date for which you want to export the data.
The output of any type of data export is one or more zip files including a folder structure with all exported
images, all metadata, and a browser based standalone application for viewing the exported images and data.
These zip files will be protected by a password, which you will receive via email.
Admin only users do not have access to patient data. They cannot perform a data export.
2.2.7 About Demetra
Medical device information
When logged in as admin or as regular user, click your name at the top of the screen in the Demetra Web
Application and select About Demetra. This page shows medical device information for BDEM-01 (e.g., model
name, part number and software versions) and the complete electronic label for the Analytics Toolkit medical
device, if applicable for your country (including model name, part number, version, legal manufacturer info and
approved countries). Also a link to the User Guides is included for both medical devices, a link to the terms
and conditions, and a link to the Barco product privacy statement at
www.barco.com/about-barco/legal/privacy-policy/product-privacy-statement.
2.3 Installation of Demetra Scope
2.3.1 Installation of the grip / battery pack
Procedure
1. Place the Demetra Scope head on a flat, stable surface.
Image 2–4
2. Ensure that the locking ring of the grip is in open position (i.e. the locking ring should be turned to the left).
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Image 2–5
3. Install the grip on the Demetra Scope head.
Image 2–6
4. Whilst holding the grip, turn the locking ring of the grip to the right (direction of the locking symbol) until it
softly clicks into the locked position.
Caution: Only turn the locking ring of the grip, not the entire grip itself.
Image 2–7
2.3.2 Removal of the grip / battery pack
Procedure
1. Place the complete Demetra Scope on a flat, stable surface.
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19K5902200 /07 Barco Demetra
Image 2–8
2. Whilst holding the grip, turn the locking ring to the left (direction of the unlocking symbol) until the grip
unlocks.
Caution: Only turn the locking ring of the grip, not the entire grip itself.
Image 2–9
3. Remove the grip from the Demetra Scope head.
Image 2–10
It may be needed to firmly pull the grip to separate it from the Demetra Scope head.
2.3.3 Installation of the non-contact cone
Non-contact cone
When capturing dermoscopic images with the Demetra Scope in non-contact mode, the non-contact cone can
be installed on the Demetra Scope head.
Installation and configuration

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Install the non-contact cone on the head of the Demetra Scope. The notch in the non-contact cone must be
fitted on the secondary camera. The non-contact cone is held in place safely through a magnetic attachment.
2.3.4 Charging the Demetra Scope
Procedure
1. Connect the adapter to the battery charging station. Route the adapter cable through the notch at the
bottom of the battery charging station to put the charging station in a stable position.
2. Place the adapter plug for your country (USA, EU or UK) into the adapter such that the plug fits into the
foreseen slots. Slide the plug downwards until it clicks.
3. Plug the adapter into the socket.
4. Place the complete Demetra Scope (with grip installed) or the separate grip in the battery charging station.
Make sure that the notches at the bottom of the grip are properly installed on the protrusions of the battery
charging station. The complete Demetra Scope (with grip installed) or the separate grip is held in place
safely in the battery charging station through a magnetic attachment.
5. The LED on the grip slowly blinks green during charging. As soon as the LED is steady green, charging is
complete.
Complete charging time (from empty batteries to fully charged batteries) is approximately 3 hours.
For use only with the delivered adapter: model ATM012T-W051V, Adapter Technology Co., Ltd.
The Demetra Scope head also includes a battery. To charge the full battery capacity, install the
complete Demetra Scope (with grip installed) in the battery charging station.
Install the battery charging station on a flat, stable surface near an easily accessible socket. Make
sure the adapter cable is routed towards the socket in a safe way to avoid damage to the cable and/
or charging station.
2.4 Setup of Demetra Scope
2.4.1 Configuration
Procedure
For the initial setup of your Demetra Scope (and also for fluent synchronization of data from the
Scope to the cloud), a good WiFi connection is required (see “Minimum system requirements”, page
12 for more information).
The Demetra Scope batteries must be fully charged before initial setup. Charge for a minimum of 2
hours before initial use.
First perform the configuration (as admin) procedure of the Demetra Web Application (see
“Configuration (admin)”, page 13).
1. Press the On/Off button to turn on the Demetra Scope. The welcome screen will be shown.
2. Check to make sure that the grip is attached to the head of the device and the locking ring is fully closed,
then proceed to the next step.
3. Follow the instructions on the display screen to link your device to your customer account (organization).
4. Scan the QR code shown in the Demetra Web Application with the Demetra Scope.
5. Once the QR code is scanned successfully, the Demetra Scope needs to be connected to a WiFi network.
6. When the WiFi connection is established, the device automatically performs a network connectivity check.
7. The device checks for software updates, and if available, downloads and installs those updates. This may
take a few moments.
Installation and configuration