Barco Demetra User Guide BDEM-01 ENABLING BRIGHT OUTCOMES
Barco NV Beneluxpark 21, 8500 Kortrijk, Belgium www.barco.com/en/support www.barco.com Registered office: Barco NV President Kennedypark 35, 8500 Kortrijk, Belgium www.barco.com/en/support www.barco.
Table of contents 1 Welcome! ................................................................................................................................................................................................................5 1.1 Use specification ..................................................................................................................................................................................6 1.2 About the Demetra solution.........................................
5 Troubleshooting..............................................................................................................................................................................................35 5.1 Troubleshooting instructions ......................................................................................................................................................36 6 Repacking instructions............................................................................................
Welcome! 1 K5902200 /02AC Barco Demetra 5
Welcome! 1.1 Use specification Indications for Use The Barco Digital Dermatoscope is a non-invasive skin analysis 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.
Welcome! The device embedded software can perform image processing, image analysis and image visualization. The device also uploads images to cloud storage. The stand-alone software application is cloud software with a related web application. This cloud software can also perform image processing, image analysis and image visualization. The cloud software can also generate one or more reports and feedback certain outputs of the image analysis back to the device. 1.
Welcome! • 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. 1.4 Demetra Scope Overview The Demetra Scope is a handheld, wireless medical device. Purpose-built for dermoscopic and clinical imaging as well as dermoscopic image analysis, the Demetra Scope offers the most detailed images, an easyclean design and smart mechanics. 8 10 11 9 12 Image 1-2 1. 2. 3. 4. 5. 6. 7.
Welcome! 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).
Welcome! 10 K5902200 /02AC Barco Demetra
Installation and configuration 2 K5902200 /02AC Barco Demetra 11
Installation and configuration 2.1 Setup of Demetra Web Application 2.1.1 Minimum system requirements Operating system Demetra Web Application is supported on the following operating systems: • • • • Microsoft Windows 7 Microsoft Windows 8 Microsoft Windows 8.1 Microsoft Windows 10 For compatibility and security reasons, please make sure to have the latest updates of your operating system installed at all times. Web browser Demetra Web Application should be connected to the internet at all times.
Installation and configuration 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 15. 2.1.
Installation and configuration Image 2-3 This screen allows the admin to: • • • • Add users/admin. Enter their email address in a free user slot. The new users will then receive a registration link by email. (Re)assign users to licenses. Select Edit users at the top of the page. Drag users to other subscription levels, as long as there is a free user slot available, or to the Other Users group. Click Save changes to confirm. Delete users/admin. Select Edit users at the top of the page.
Installation and configuration Account policies Those were already set during the previous steps of the configuration (permission model and security policies). Through this screen it is possible to change these settings (except the permission model). These settings (except the permission model) can also be changed later on (only when logged in as admin) by clicking on the name of the admin (in the Demetra Web Application) and selecting Admin settings. Then select the tab Account policies. 1.
Installation and configuration 2.2 Installation of Demetra Scope 2.2.1 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). Image 2-5 3. Install the grip on the Demetra Scope head. Image 2-6 4.
Installation and configuration Caution: Only turn the locking ring of the grip, not the entire grip itself. Image 2-7 2.2.2 Removal of the grip / battery pack Procedure 1. Place the complete Demetra Scope on a flat, stable surface. 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.
Installation and configuration Image 2-10 It may be needed to firmly pull the grip to separate it from the Demetra Scope head. 2.2.3 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. This protects the contact glass in the head of the Demetra Scope from any contamination due to possible skin infections (lesion).
Installation and configuration 2.3 Setup of Demetra Scope 2.3.1 Configuration Procedure A good Wifi connection is required for sufficient performance of your Demetra Scope. The Demetra Scope battery 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.
Installation and configuration 2.4 When the Demetra subscription is terminated Instructions 1. When your subscription is terminated, the Demetra Scope must be returned to Barco using your original packaging (see “Repacking instructions”, page 37). 2. 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. 3.
Operation with the Demetra Scope 3 K5902200 /02AC Barco Demetra 21
Operation with the Demetra Scope 3.1 Start the Demetra Scope Log in When logging in as user, first perform the configuration (user) procedure (see “Configuration (user)”, page 15). 1. Press the On/Off button to turn on the Demetra Scope. 2. Select the desired user. Depending on the authentication method (PIN code or no authentication) set in the user configuration (see “Configuration (user)”, page 15), enter the set PIN code (if needed) to log in on the Demetra Scope. 3.
Operation with the Demetra Scope 10. Tap the overview icon to localize the captured image on an overview photograph. 11. Select the desired overview photograph on which you want to localize the captured image. This can be an existing overview photograph, or a new overview photograph can be captured. Shortly press the On/Off button on top of the head to put the device in standby mode. Keep the On/ Off button pressed to open a menu which allows you to safely restart or shut down the Demetra Scope. 3.
Operation with the Demetra Scope 3.4 Image detail screen Overview 2 1 3 4 5 6 7 Image 3-3 1. Automatically assigned image number 2. Lesion number: Links the image to a location on an overview photograph or on a dummy mannequin 3. Localize: Allows to localize a dermoscopic or close-up image on an overview photograph or on a dummy mannequin 4. Compare the selected image to any other image (previous image of the same lesion and of the same image type by default (if available) 5.
Operation with the Demetra Scope 3.5 Localize (on clinical overview) Overview 1 2 Image 3-4 1. Automatically assigned image number 2. Add a new lesion marker and/or edit existing lesion marker(s) on the clinical overview photograph (and attach a dermoscopic or close-up image to those markers in the next steps) 3.6 Diagnose Overview 1 2 3 Image 3-5 1. On the Demetra Scope it is possible to select a tentative diagnosis from the predefined list. 2.
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. When no management strategy is selected, lesion markers are displayed in grey.
Operation with the Demetra Web Application 4 K5902200 /02AC Barco Demetra 27
Operation with the Demetra Web Application 4.1 Open the Demetra Web Application Log in 1. Open the web browser on your workstation. 2. Browse to https://demetra.barco.com 3. 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.
Operation with the Demetra Web Application 2. Gallery tab: Click this tab to view all saved images or photographs (of all patients). The following filters are available in this gallery: • Diagnosis: This filter allows to show all images with a selected diagnosis. If available, the pathologyproven diagnosis is used in this filter. Otherwise the tentative diagnosis is used. • Management: This filter allows to show all images with a selected management strategy assigned to them.
Operation with the Demetra Web Application The following filters are available: • Diagnosis: This filter allows to show all images with a selected diagnosis. If available, the pathologyproven diagnosis is used in this filter. Otherwise the tentative diagnosis is used. • Management: This filter allows to show all images with a selected management strategy assigned to them. • Image type: This filter allows to show all images of the selected image type.
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: 3 5 Image 4-5 1. 2. 3. 4. 5.
Operation with the Demetra Web Application Image 4-6 1. Zoom in/out 2. Pan the image by keeping the left mouse button pressed and move the mouse pointer in the desired direction 3. Rotate image 4. Show image on full screen 5. Show polarized/non-polarized image 6. Add/remove digital scale 7. View all images linked to the selected image e.g. previous images of the same lesion or body part, or linked images of the other image types 8.
Operation with the Demetra Web Application 4.6 Diagnose Overview 1 2 2 3 Image 4-7 1. 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. 2. It is also possible to select a pathology-proven diagnosis in the same way as a tentative diagnosis. A pathology report can be added. 3. Also a management strategy can be selected from the predefined list.
Operation with the Demetra Web Application 34 K5902200 /02AC Barco Demetra
Troubleshooting 5 K5902200 /02AC Barco Demetra 35
Troubleshooting 5.1 Troubleshooting instructions Please check the Demetra knowledge base on www.barco.com/support for the most recent troubleshooting information. No live video preview 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.
Repacking instructions 6 K5902200 /02AC Barco Demetra 37
Repacking instructions 6.1 Repacking overview Overview 6 4 5 7 8 3 9 11 2 10 1 Image 6-1 1. 2. 3. 4. 5. 6. 7. 8. 9.
Repacking instructions 10. Adapter 11.
Repacking instructions 40 K5902200 /02AC Barco Demetra
Cleaning and disinfection 7 K5902200 /02AC Barco Demetra 41
Cleaning and disinfection 7.1 Instructions 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. Disinfection is required at least before every new patient examination, and after touching breached or compromised skin surfaces with the device.
8 Important information General information This device is for use in professional healthcare facility environments only. 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.
Important information 8.1 Safety information General recommendations Read the safety and operating instructions before operating the device. Retain safety and operating instructions for future reference. Adhere to all warnings on the device and in the operating instructions manual. Follow all instructions for operation and use. Electrical Shock, Fire Hazard and Mechanical Hazard Only in accordance with ANSI/AAMI ES 60601-1 (2005) + AMD (2012) and CAN/CSA-C22.2 No.
Important information Image review To have sufficient image quality, a suitable display should be used to review images in the Demetra Web Application (see the part ‘Requirements’ in the chapter “Activation”, page 12 for more details). High magnetic environment • • The device shall not be used in the high magnetic environment of an MRI scanner. The installer shall assess the magnetic environment before installation or use of the device. Water and moisture Never expose the device to rain or moisture.
Important information National Scandinavian Deviations for CL. 1.7.2 Finland: "Laite on liitettävä suojamaadoituskoskettimilla varustettuun pistorasiaan" Norway: "Apparatet må tilkoples jordet stikkontakt" Sweden: "Apparaten skall anslutas till jordat uttag" 8.
Important information FCC class B This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
Important information La bande 5 150-5 250 MHz est réservés uniquement pour une utilisation à l'intérieur afin de réduire les risques de brouillage préjudiciable aux systèmes de satellites mobiles utilisant les mêmes canaux. For the frequency 5600-5650 MHz, no operation is permitted. Pour la fréquence 5600-5650 MHz, aucune opération est autorisée. Radiation exposure statement These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue.
Important information Emissions test Compliance Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 Class A Electromagnetic environment – Guidance domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes. Complies This Demetra solution complies with appropriate medical EMC standards on emissions to, and interference from surrounding equipment.
Important information Immunity test IEC 60601 test levels Compliance level 3 Vrms (6 Vrms in ISM bands) 150 kHz to 80 MHz 3 V/m 80 MHz to 2.
Important information Indicates compliance with Part 15 of the FCC rules Indicates the device is approved according to the UL regulations MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1 (2005) + AMD (2012) and CAN/CSA-C22.2 No.
Important information Indicates the legal manufacturer Indicates the manufacturing date yy Indicates the temperature limitations2 for the device to safely operate within specs xx SN REF REV Indicates the device serial number Indicates the device part number or catalogue number Revision of the part number or catalogue number Warning: dangerous voltage Caution Consult the operating instructions Indicates this device must not be thrown in the trash but must be recycled, according to the European WEEE
Important information Indicates a medical device that can be broken or damaged if not handled carefully when being stored. Indicates a medical device that needs to be protected from moisture when being stored. Indicates the storage direction of the box. The box must be transported, handled and stored in such a way that the arrows always point upwards. Indicates the maximum number of boxes to be stacked on each other. 15 n Indicates that the box should be carried with two persons.
Important information 54 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: synchronizing Edit mode for lesion markers (add/edit/ remove) Cloud connection indicator: synchronizing error Add new marker Patient Edit Physician (user) Undo Admin user Rotate clockwise Ph
Important information Switch patient Generate report Image gallery View report • • Zoom in Mannequin view of image gallery Localize on mannequin Hierarchical view of image gallery Zoom out Chronological view of image gallery Pan Switch image mode Notification Dermoscopic mode Warning Close-up mode Image swap (select image) • Lock rotation • Overview mode (to capture an image) Localize on clinical overview Switch camera (in close-up mode) Lock pan Overlay Lock zoom Polarized/non-pol
Important information 8.7 Legal disclaimer Disclaimer notice Although every attempt has been made to achieve technical accuracy in this document, we assume no responsibility for errors that may be found. Our goal is to provide you with the most accurate and usable documentation possible; if you discover errors, please let us know. Barco software products are the property of Barco. They are distributed under copyright by Barco NV or Barco Inc.
Important information Dimensions scope (head + grip mounted) (H x W x D) 231 x 143 x 78 mm Dimensions packaged (D x W x H) 347 x 260 x 150 x mm Net weight scope (head + grip mounted) • • Net weight packaged (box with all parts included) 2.
Barco NV President Kennedypark 35 8500 Kortrijk Belgium K5902200 /02AC | 2019-09-09 Barco NV | Beneluxpark 21, 8500 Kortrijk, Belgium Registered office: Barco NV | President Kennedypark 35, 8500 Kortrijk, Belgium www.barco.
