Charging the Demetra Scope ..........................18 Setup of Demetra Scope ................................19 2.3.1 Configuration..................................19 2.3.2 Status bar ...................................19 When the Demetra subscription is terminated .........................20 3 Operation with the Demetra Scope..............................21 Start the Demetra Scope ................................22 Basic workflow....................................22 Live video preview....................................23 Image detail screen ..................................24 Localize (on clinical overview)..............................25...
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Regulatory compliance information ............................46 8.3.1 EU statement..................................46 8.3.2 FCC statement ................................46 8.3.3 Industry Canada statement - Avis d'industrie Canada................47 8.3.4 General information..............................48 EMC notice ......................................48 Explanation of symbols..................................50 Explanation of icons ..................................53 Legal disclaimer....................................56 Technical specifications.................................56 K5902200 /02AC Barco Demetra...
The final clinical decision is with the trained medical practitioner. 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.
1.2 About the Demetra solution General The Demetra solution is a platform for skin examination and analysis. It consists of the following main parts: Demetra Scope for capturing images and optimizing the imaging and documentation workflow. Wireless and secure transfer of images and metadata from the device memory to the cloud, via wifi, for image processing and storage in the cloud.
Secondary camera for clinical overview photographs and clinical close-up photographs (more than 10 cm from the skin) Non-contact cone Locking ring The power supply is specified as a part of the Demetra Scope. Use only the delivered power supply for charging your device. K5902200 /02AC Barco Demetra...
1.5 Demetra Web Application Overview The Demetra Web Application is an on-line application which allows the user to view, manage and analyze 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 27 for more information).
2.1.2 Activation User authentication When you purchased a Demetra subscription, you will receive a registration link by e-mail. Click this link to register as admin. As admin it is possible to create / assign new users (see “Configuration (admin)”, page 13). When a new user has been added, he will also receive a registration link by e-mail.
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 15.
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This screen shows the different Demetra Scopes that are linked to the customer account (organization). Click on the specific Demetra Scope to view the device information. Through this screen it is also possible to add (link) a specific Demetra Scope to this customer account. To add (link) a Demetra Scope Select the tab Device overview.
2.1.5 Settings Admin When logged in as admin, click your name at the top of the screen in the Demetra Web Application and select Admin settings. Select the appropriate tab and edit the settings as desired. See the chapters ‘Users and licenses’, ‘Device overview’...
2.2.1 Installation of the grip / battery pack Procedure Place the Demetra Scope head on a flat, stable surface. Image 2-4 Ensure that the locking ring of the grip is in open position (i.e. the locking ring should be turned to the left).
2.2.2 Removal of the grip / battery pack Procedure Place the complete Demetra Scope on a flat, stable surface. Image 2-8 Whilst holding the grip, turn the locking ring to the left (direction of the unlocking symbol) until the grip unlocks.
When capturing dermoscopic images with the Demetra Scope in non-contact mode, the non-contact cone can be installed on the Demetra Scope head. This protects the contact glass in the head of the Demetra Scope from any contamination due to possible skin infections (lesion).
Once the Wifi connection is established, the Demetra Scope is linked to the customer account and the device is ready for use. 2.3.2 Status bar Overview The status bar at the top right corner of the Demetra Scope display can be swiped down to: • Log out the current user •...
(see “Repacking instructions”, page 37). There is a possibility to download your patient data from the Demetra solution after terminating your subscription. If you wish to do so, contact the Barco Helpdesk within 60 days after the end date of your subscription.
[...] Image 3-1 Press the On/Off button on top of the Demetra Scope head. The live video preview screen will be shown. Tap the image mode icon on the display screen and select the desired image mode.The following image modes are available: •...
Off button pressed to open a menu which allows you to safely restart or shut down the Demetra Scope. 3.3 Live video preview Overview Press the main button on the grip of the Demetra Scope to return to the live video preview from any other screen. Image 3-2 Battery status indicator...
Operation with the Demetra Scope 3.4 Image detail screen Overview Image 3-3 Automatically assigned image number Lesion number: Links the image to a location on an overview photograph or on a dummy mannequin Localize: Allows to localize a dermoscopic or close-up image on an overview photograph or on a dummy...
Overview Image 3-5 On the Demetra Scope it is possible to select a tentative diagnosis from the predefined list. It is not possible to select a pathology-proven diagnosis. This function is only available through the Demetra Web Application). Once selected via the Demetra Web Application, the pathology-proven diagnosis will be shown on the Demetra Scope as well.
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Operation with the Demetra Scope • Excision or biopsy: Red • Treatment, excision, biopsy finished: Blue Once a management strategy is selected for a specific lesion, the marker of this lesion on the dummy mannequin or on a clinical overview photograph is displayed in the color of the management strategy.
Operation with the Demetra Web Application 4.1 Open the Demetra Web Application Log in Open the web browser on your workstation. Browse to https://demetra.barco.com The Login screen will be shown. Fill in your e-mail address and password (set through user authentication, see “Activation”, page 12) and click Sign in.
Image type: This filter allows to show all images of the selected image type. Notifications: Click the “down” icon to see important notifications. Physician (user) information: Shows the physician (user) who is logged in on the Demetra Web Application. Click the “down” icon to choose Settings or Sign out: •...
About the image detail screen The image detail screen is shown when a captured image is selected (by clicking on the thumbnail of the captured image). This is possible from different locations in the Demetra Web Application (such as the K5902200 /02AC...
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Operation with the Demetra Web Application different image gallery modes and the images of the current consultation (shown below the dummy mannequin in the Consultations screen)). Image information The following information is shown in the image detail screen: Image 4-5...
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Operation with the Demetra Web Application Image 4-6 Zoom in/out Pan the image by keeping the left mouse button pressed and move the mouse pointer in the desired direction Rotate image Show image on full screen Show polarized/non-polarized image Add/remove digital scale View all images linked to the selected image e.g.
Overview Image 4-7 On the Demetra Web Application it is possible to select a tentative diagnosis from the predefined list or add your own diagnosis by selecting Other and specifying your diagnosis in the available text field. It is also possible to select a pathology-proven diagnosis in the same way as a tentative diagnosis. A pathology report can be added.
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Operation with the Demetra Web Application K5902200 /02AC Barco Demetra...
Fully recharge the battery and check again. If the condition persists, your Demetra Scope may require servicing. LED fails The LEDs used in your Demetra Scope are designed to last over 100,000 hours. If any of the LEDs fail, your Demetra Scope requires servicing. LED indicator error codes In case the LED indicator in the grip of the device shows other behavior than during normal operation, please contact the Barco helpdesk.
To disinfect the contact glass and biocompatible plastic of the Demetra Scope The exterior and contact glass of your Demetra Scope may be cleaned and disinfected by wiping it with a recognized product for disinfection. Read and follow all label instructions on the disinfection product.
With the installation of the device, use only the delivered external cables and power supply or a spare part provided by the legal manufacturer. Using another can result in a decrease of the immunity level of the device. K5902200 /02AC Barco Demetra...
Battery and charging Your Demetra Scope uses a special lithium battery, which can only be purchased from Barco or from an authorized Barco dealer. Do not under any circumstances use another battery other than the one designed for this unit. Doing so could result in damage to the unit.
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Eye safety Hold your Demetra Scope so that the LEDs are aimed in the direction of the lesion to be examined. Do not look directly into the bright LED light. It is recommended that patients close their eyes during examinations.
> click Settings). 8.3.1 EU statement RF information Hereby, Barco NV declares that this device is in compliance with the Directive 2014/53/EU. The full text of the EU declaration of conformity is available at: https://www.barco.com/support/Demetra/docs The device is restricted to indoor use only when operating in the 5150 to 5350 MHz frequency range.
Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. FCC responsible: Barco Inc., 3059 Premiere Parkway Suite 400, 30097 Duluth GA, United States, Tel: +1 678 475 8000...
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Demetra solution, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Consult the dealer or an experienced technician for help. Electromagnetic immunity The Demetra solution is intended for use in the electromagnetic environment specified below. The customer or the user of the Demetra solution should assure that it is used in such an environment.
5240 5100 – 5800 W LAN Pulse 802.11 a/n modulation 5500 217 Hz 5785 8.5 Explanation of symbols Symbols on the device On the device or power supply, you may find the following symbols (nonrestrictive list): K5902200 /02AC Barco Demetra...
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Caution: Federal law (United Stated of America) restricts this device to sale by or on the order of a licensed healthcare practitioner. Indicates the USB connectors on the device Indicates the DisplayPort connectors on the device Type BF applied part Class II equipment K5902200 /02AC Barco Demetra...
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Stand-by Equipotentiality Protective earth (ground) Symbols on the box On the box of the device, you may find the following symbols (nonrestrictive list): Values for xx and yy can be found in the technical specifications paragraph. K5902200 /02AC Barco Demetra...
106 kPa the medical device can be safely exposed when being stored. 50 kPa 8.6 Explanation of icons Overview Settings Add/remove digital scale Device Delete image Battery status: full Save image Battery status: empty Compare images K5902200 /02AC Barco Demetra...
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Important information Battery issue (contact Barco helpdesk) Analyze Wifi error: offline Diagnose Wifi status: full strength Add follow-up image Wifi status: no Wifi Image set Protected Wifi network Take new image Wifi warning: no internet connection No localization Cloud connection indicator:...
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Image swap (select image) • Overview mode (to capture an Lock rotation image) • Localize on clinical overview Switch camera (in close-up mode) Lock pan Overlay Lock zoom Polarized/non-polarized image Show legal information Brightness low Autofocus Brightness full K5902200 /02AC Barco Demetra...
Barco software products are the property of Barco. They are distributed under copyright by Barco NV or Barco Inc., for use only under the specific terms of a software license agreement between Barco NV or Barco Inc. and the licensee. No other use, duplication, or disclosure of a Barco software product, in any form, is authorized.
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CE, ANSI/AAMI ES 60601-1 (2005) + AMD (2012) and CAN/CSA-C22.2 No. 60601-1 (2014) EMI: EN 60601-1-2 : 2015, IEC 60601-1-2 ed 4.0, EN55011 : 2009+A :2010, CISPR 11 ed 5.1, IEC 60601-2-57, FCC Part 15, ICES-003/NMB-003 Radio Equipment Directive 2014/53/EU K5902200 /02AC Barco Demetra...
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