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1 2 | User Manual | Users Manual | 1.07 MiB | April 10 2019 / May 10 2019 |
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.com Table of contents 1 Welcome!................................................................................................................................................................................................................5 Use specification..................................................................................................................................................................................6 1.1 1.2 About the Demetra solution............................................................................................................................................................7 1.3 Whats in the box..................................................................................................................................................................................7 Demetra Scope.....................................................................................................................................................................................8 1.4 1.5 Demetra Web Application ...............................................................................................................................................................9 2.2 2.1 2 Installation and configuration............................................................................................................................................................... 11 Setup of Demetra Web Application.........................................................................................................................................12 2.1.1 Minimum system requirements..............................................................................................................................12 Activation............................................................................................................................................................................12 2.1.2 Configuration (admin)..................................................................................................................................................13 2.1.3 2.1.4 Configuration (user)......................................................................................................................................................15 2.1.5 Settings................................................................................................................................................................................15 Installation of Demetra Scope....................................................................................................................................................16 Installation of the grip / battery pack....................................................................................................................16 2.2.1 Removal of the grip / battery pack........................................................................................................................17 2.2.2 2.2.3 Installation of the non-contact cone.....................................................................................................................18 2.2.4 Charging the Demetra Scope .................................................................................................................................18 Setup of Demetra Scope ..............................................................................................................................................................19 2.3.1 Configuration....................................................................................................................................................................19 Status bar...........................................................................................................................................................................19 2.3.2 2.4 When the Demetra subscription is terminated .................................................................................................................20 2.3 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 Diagnose................................................................................................................................................................................................25 3.1 3.2 3.3 3.4 3.5 3.6 4 Operation with the Demetra Web Application............................................................................................................................27 4.1 Open the Demetra Web Application.......................................................................................................................................28 4.2 Main menu............................................................................................................................................................................................28 Patient detail screen........................................................................................................................................................................29 4.3 4.4 Consultations screen......................................................................................................................................................................30 Image detail screen .........................................................................................................................................................................30 4.5 Diagnose................................................................................................................................................................................................33 4.6 4.7 Reports ...................................................................................................................................................................................................33 K5902200 /02AC Barco Demetra 3 5 Troubleshooting..............................................................................................................................................................................................35 Troubleshooting instructions ......................................................................................................................................................36 5.1 6 Repacking instructions..............................................................................................................................................................................37 Repacking overview........................................................................................................................................................................38 6.1 7 Cleaning and disinfection........................................................................................................................................................................41 Instructions...........................................................................................................................................................................................42 7.1 8.1 8.2 8.3 8 Important information.................................................................................................................................................................................43 Safety information.............................................................................................................................................................................44 Environmental information...........................................................................................................................................................46 Regulatory compliance information........................................................................................................................................46 8.3.1 EU statement....................................................................................................................................................................46 FCC statement ................................................................................................................................................................46 8.3.2 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 8.4 8.5 8.6 8.7 8.8 4 K5902200 /02AC Barco Demetra 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. A number of considerations should be taken into account:
The touch display of the device can be operated wearing gloves. The following types of gloves were tested It should be avoided to operate the device with wet hands, in order to prevent dropping the device. 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. 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, including, but not limited to, melanoma and non-melanoma skin cancers or lesions suspicious for skin cancer, inflammatory skin conditions, skin infections, etc. Medical conditions to be diagnosed, treated and/or monitored Skin conditions, including, but not limited to, melanoma and non-melanoma skin cancers or lesions suspicious for skin cancer, inflammatory skin conditions, skin infections, etc. 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. In case of small breached or compromised lesions, it is recommended to install the non-contact cone on the Demetra Scope to perform non-contact dermoscopy. In case of large breached or compromised lesions, the non-contact cone should not be used. Contra-Indications The device is not a Computer Aided Diagnosis (CAD) device. The additional information that the device provides is intended as an aid for the trained medical practitioner when reviewing, analyzing and diagnosing skin images. 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. The hardware device is a portable, battery powered medical device for acquiring, processing 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. 6 K5902200 /02AC Barco Demetra 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. 1.2 About the Demetra solution General The Demetra solution is a platform for skin examination and analysis. 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 image processing and storage in the cloud. 3. Secure Demetra Web Application for complete patient record and image library management and workflow tools. 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 or 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 Whats in the box Overview Demetra Scope head Rechargeable grip / battery pack Battery charging station Non-contact cone Adapter and plugs Quick Start Guide K5902200 /02AC Barco Demetra 7 123 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 easy-
clean design and smart mechanics. 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 battery (>20%) Steady orange: Battery low (20%) Slow blinking green: Battery charging (when placed in battery charging station) Steady green: Battery fully charged (when placed in battery charging station) 8. On/Off button 9. Head with primary camera for dermoscopic imaging and clinical close-up photographs (up to 510 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. 8 K5902200 /02AC Barco Demetra 81091211 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). K5902200 /02AC Barco Demetra 9 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. The following web browsers are supported:
Google Chrome (version 63 or higher) Mozilla Firefox (version 57 or higher) Microsoft Edge Microsoft Internet Explorer (version 11 or higher) 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 adequate viewing experience, we recommend to use a display with a minimum resolution of 1920 x 1080 pixels. The displays from Barcos clinical range are an excellent match when using Demetra Web Application. 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. Click this link to register as user. Image 2-1 12 K5902200 /02AC Barco Demetra 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. Installation and configuration 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. 2.1.3 Configuration (admin) Language and color scheme 1. After user authentication as admin (see Activation, page 12), click Start configuration on the Demetra welcome screen. 2. Select the desired Language and Color scheme and click Next to confirm. Permission model and security policies 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 afterwards. Click Next to confirm. 2. Select the desired security setting:
Device authentication: Determine which authentication methods (PIN or no authentication) are 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 15). 3. Click Next to confirm. 4. An overview of the selected settings is shown. Tick the checkbox I have read the Barco privacy policy and click Accept to confirm. Click Barco privacy policy to open and read the Barco privacy policy. These settings are now general for each user. To change the settings per user, see 'Users and licenses under Configuration (admin), page 13. Users and licenses There are two types of users: admin users and regular users. By default, admin users have administration privileges only, without access to patient records. By default, regular users have access to patient records, without administration privileges. Both roles can also be combined (see below). K5902200 /02AC Barco Demetra 13 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. Click Delete next to the user name. Click Change the settings per individual user. Select the specific user and change the settings as desired. Click Save changes to confirm. Save changes to confirm. Admin users are by default shown in the group Other Users. In order for an admin user to get access to patient records, he needs to be moved to a free user slot under a certain subscription level. A regular user can be assigned administration privileges by clicking on the user name, ticking the checkbox Admin privileges enabled and clicking Save changes. These settings can 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 Users and licenses. Device overview 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 1. Select the tab Device overview. 2. Perform the configuration of the Demetra Scope (see Configuration, page 19) to link a device to the customer account. These settings can 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 Device overview. 14 K5902200 /02AC Barco Demetra 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. Select the tab Account policies. 2. Select the desired security settings and click Save changes to confirm. The following security setting can be changed:
Device authentication: Determine which authentication methods (PIN or no authentication) are 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 15). 2.1.4 Configuration (user) Settings Adapt the settings according to your personal preferences in order to have optimal working conditions with the Demetra solution. 1. After user authentication (see Activation, page 12) click Start configuration on the Demetra welcome screen. In the personal information screen, fill in your first name, last name and telephone number and click Next to confirm. 2. 3. Adapt the settings as desired and click Next to confirm. The following setting can be adapted:
Device authentication: Click Change device authentication to configure your device authentication. Depending on the security policies set by the admin (see Configuration (admin), page 13), it is possible to either set your PIN code or choose for no authentication needed to log in on the Demetra Scope. Click Next to confirm. 4. Carefully read the safety warnings and recommendations related to the usage of the Demetra Scope. Tick the checkbox I have read and understand the safety warnings and recommendations and click Next to confirm. 5. An overview of the selected settings is shown. Tick the checkbox I have read the Barco privacy policy and click Accept to confirm. You are now all set as a user and are able to operate the Demetra Scope. Click Barco privacy policy to open and read the Barco privacy policy. These settings can be changed later on, see the chapter User under Settings, page 15. 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 and Account policies under Configuration (admin), page 13 for more details. User When logged in as user, click your name at the top of the screen in the Demetra Web Application and select Settings. Edit the settings as desired and click Save changes to confirm. K5902200 /02AC Barco Demetra 15 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. Whilst holding the grip, turn the locking ring of the grip to the right (direction of the locking symbol) until it clicks into the locked position. 16 K5902200 /02AC Barco Demetra Caution: Only turn the locking ring of the grip, not the entire grip itself. Installation and configuration 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. K5902200 /02AC Barco Demetra 17 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). 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. 2.2.4 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 is slowly blinking green during charging. As soon as the LED is steady green, charging is complete. Complete charging time (from empty battery to fully charged battery) 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. 18 K5902200 /02AC Barco Demetra 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. 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. When the QR code was scanned successfully, the Demetra Scope needs to be connected to a Wifi network. 6. 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:
Access the Settings menu (including legal information) View the remaining battery level Access the network settings View the cloud synchronization status View patient information and/or select a(nother) patient Log out the current user Image 2-11 K5902200 /02AC Barco Demetra 19 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. When returning the Demetra Scope to Barco, a factory reset will be performed, erasing all data from the device. 20 K5902200 /02AC Barco Demetra 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. 3.2 Basic workflow Overview Image 3-1 1. Press the On/Off button on top of the Demetra Scope head. The live video preview screen will be shown. 2. Tap the image mode icon on the display screen and select the desired image mode.The following image modes are available:
Dermoscopic mode Close-up mode Overview mode 3. Zoom in/out on the displayed area as desired by scrolling the left touchpad upwards/downwards. Manually adjust the focus of the primary camera by scrolling the right touchpad on the grip of the Demetra Scope. Return to autofocus by tapping the AF icon that appears on the right hand side of the display as soon as the right touchpad on the grip is touched. Manual focus adjustment is only available when dermoscopic mode is selected. 4. Capture an image by pressing the main button on the grip of the Demetra Scope. 5. When an image is captured, the image review screen will be shown. In this screen, the user can perform several actions. 6. Tap the Save icon in the image review screen to save the captured image to the image gallery. 7. When the captured image is saved, the image detail screen will be shown. See Image detail screen, page 24) for an overview of the available functionalities. 8. Tap the Localize icon in the image detail screen to link the captured image taken in dermoscopic mode or close-up mode to a location marked on an overview photograph or on a dummy mannequin. 9. Tap the mannequin icon to localize the captured image on a dummy mannequin. 22 K5902200 /02AC Barco Demetra 1234567891011[...]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. 3.3 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 1. Battery status indicator 2. Wifi connection indicator 3. Cloud connection indicator 4. Patient name 5. Switch patient: Tap to switch patient 6. Image gallery of the selected patient Image mode: Tap the icon to select the desired image mode 7. When close-up mode is selected, tap the switch camera icon on the display screen to either use the primary camera (up to 510 cm from the skin) or secondary camera (more than 10 cm from the skin). Depending on the selected image mode, additional illumination is turned on or off automatically. This additional illumination is turned on when the device is operating in dermoscopic mode or in close-up mode with the primary camera. In the other image modes, this additional illumination is turned off. 8. Polarized/non-polarized illumination 9. Add/remove digital scale K5902200 /02AC Barco Demetra 23 123467985 Operation with the Demetra Scope 3.4 Image detail screen Overview 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. Analyze: Future functionality 6. Diagnose: Add diagnosis and/or management strategy 7. Add follow-up image of the same lesion (in the same image mode) 24 K5902200 /02AC Barco Demetra 1234567 3.5 Localize (on clinical overview) Overview Operation with the Demetra Scope 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 Image 3-5 1. On the Demetra Scope it is possible to select a tentative diagnosis from the predefined list. 2. 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. 3. Also a management strategy can be selected from the predefined list. Each management strategy is represented by a specific color:
No follow-up or treatment: Grey Follow-up: Yellow Treatment: Orange K5902200 /02AC Barco Demetra 25 21123 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. 26 K5902200 /02AC Barco Demetra 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. When logging in for the first time, the configuration start screen will be shown which will guide you through the configuration procedure, see Configuration (admin), page 13 when logged in as admin or Configuration (user), page 15 when logged in as user. Image 4-1 When you forgot your password or want to change it, click Forgot your password?, enter your e-mail address and click Reset password. You will receive a reset link by e-mail, click this link to set a new password. 4.2 Main menu Overview The Main menu bar on top of the first screen after login contains the Main menu functionalities:
Image 4-2 1. Patients tab: Click this tab to add a new patient or select the desired patient and start a new consultation. 28 K5902200 /02AC Barco Demetra 1234 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 pathology-
proven 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. 3. Notifications: Click the down icon to see important notifications. 4. 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:
Click Settings to edit the physician (user) information and settings (see Settings, page 15). Click Sign out to sign out from the Demetra Web Application. By default, the Patients tab is selected. 4.3 Patient detail screen Overview The patient detail screen is shown when a new consultation is started for an existing patient or when a new patient has been created and saved from the Patients tab in the main menu. By default, the Consultations tab of the patient detail screen is selected. Image 4-3 1. Consultations tab: Click this tab to show the Consultations screen of the selected patient (see Consultations screen, page 30). 2. Gallery tab: Click this tab to view all captured images of the selected patient. The images can be shown in three different views:
Mannequin view Hierarchical view Chronological view K5902200 /02AC Barco Demetra 29 12345 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 pathology-
proven 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. From these image gallery views, clicking on any image thumbnail opens the image detail screen of this image (see Image detail screen, page 30). 3. Reports tab: Click this tab to view the Reports of the selected patient or generate a new report. 4. Patient name: Shows the selected patient. 5. Patient information: Click this button to consult and/or edit the information of the selected patient. 4.4 Consultations screen Overview Image 4-4 1. Dummy mannequin: Shows the location of the captured images, provided they were localized on the dummy mannequin, from all consultations (previous and current). Click on a lesion marker or highlighted body part to view the images/photographs that are linked to that respective marker (for dermoscopic images or close-up photographs) or body part (for overview photographs). 2. Consultation history: Shows the previous consultations of the selected patient in chronological order. For each previous consultation it is possible to:
Edit the consultation summary View the images captured during the consultation View the saved report(s) (if any) Generate a new report: A standard report of the consultation can be created (see Reports, page 33). 3. Current consultation: Allows the user to add a summary of the current consultation of the selected patient. A report can be generated (see Reports, page 33). Images/photographs captured during the current consultation are shown below the dummy mannequin. 4.5 Image detail screen 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 30 K5902200 /02AC Barco Demetra 1232 Operation with the Demetra Web Application image gallery modes and the images of different mannequin in the Consultations screen)). Image information The following information is shown in the image detail screen:
the current consultation (shown below the dummy Image 4-5 1. Lesion number: Links the image to a location on a clinical overview image or dummy mannequin 2. Automatically assigned image number 3. Date when the image was captured 4. Time when the image was captured 5. Image mode in which the image was captured:
Dermoscopic mode Close-up mode Overview mode Image captured with or without the non-contact cone installed 6. Image detail screen functionalities The following functionalities are available through the image detail screen:
K5902200 /02AC Barco Demetra 31 53 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. Compare the selected image to any other image (previous image of the same lesion and of the same image type by default, if available) 9. Localize: When a dermoscopic or close-up image is selected, this function allows the user to localize this image on a clinical overview photograph or on a dummy mannequin 10.Analyze: Future functionality 11. Diagnose (seeDiagnose, page 33 for more information) 12.Delete the selected image 13.Add a new lesion description or edit an existing lesion description. A lesion description is always linked to a lesion and never to an individual image. By consequence the lesion description will be the same for all images of the same lesion. 32 K5902200 /02AC Barco Demetra Operation with the Demetra Web Application 4.6 Diagnose Overview 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. It is also possible to select a pathology-proven diagnosis in the same way as a tentative diagnosis. A pathology report can be added. 2. 3. Also a management strategy can be selected from the predefined list. Each management strategy is represented by a specific color:
No follow-up or treatment: Grey Follow-up: Yellow Treatment: Orange 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. 4.7 Reports Generate a report The Reports tab in the patient menu allows to generate a standard report for a selected consultation date. This report includes the following information:
Report information (physician, consultation date, report creation date, imaging device used) Consultation summary Patient information (to the extent this information is completed in the Patient information tab) Dummy mannequin with lesion markers All images of the selected consultation with related information (localization, description, diagnosis, management strategy) K5902200 /02AC Barco Demetra 33 1232 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. 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. Normal operation of this LED indicator includes the following:
Off: Default behavior/charged battery (>20%) Steady orange: Battery low (20%) Slow blinking green: Battery charging (when placed in battery charging station) Steady green: Battery fully charged (when placed in battery charging station) The device doesnt charge Check the power cable connection Has the adapter cable been plugged in correctly into the battery charging station?
Has the country adapter plug been attached properly?
Use only the power supply included in the Demetra box, or a spare part provided by Barco, for charging your device. Service procedures First line support should be obtained from a Barco Authorized Reseller, if applicable. Second line support under DemetraCare is made available by Barco during regional business hours as specified on www.barco.com/support. Refer to www.barco.com/support/knowledge-base/KB5034 for more details on how to create a myBarco account and service ticket. Customers are encouraged to contact the helpdesk via the e-portal and to use available on-call services for critical and time sensitive issues only. Logging service tickets through the e-portal is recommended good practice to ensure that support requests are properly routed and escalated. Customers requests shall be made by a dedicated professional who may be an employee or a service provider of Customer; who should be knowledgeable about the Application and the operating environment;
who shall not be replaced without written notice to Barco (the Customer Contact). A service ticket:
- Can be opened by the Customer Contact only
- Should include at least the following information:
information on the nature, causes, and impact of the issue, in as much detail as possible log files, configuration files, screen images, and other information required for issue troubleshooting and analysis remote login or VPN access to Customers systems, where required (and where permitted by Customer security policies), or, as an alternative, direct access to Customers systems while in contact with Barco any other information reasonably requested by Barco to timely respond to questions and requests
- The Customer Contact shall confirm to Barco whether Barcos support has resolved Customers issue
- Barco may close a service ticket on written notice to Customer in the absence of Customers confirmation or when the issue, in Barcos reasonable opinion is resolved. 36 K5902200 /02AC Barco Demetra Repacking instructions 6 K5902200 /02AC Barco Demetra 37 Repacking instructions 6.1 Repacking overview Overview Image 6-1 1. Box 2. Bottom buffer 3. Middle buffer 4. Top buffer 5. Demetra Scope head 6. User documentation 7. Non-contact cone 8. Rechargeable grip / battery pack 9. Battery charging station 38 K5902200 /02AC Barco Demetra 1235467891110 10.Adapter 11. Plugs Repacking instructions K5902200 /02AC Barco Demetra 39 Repacking instructions 40 K5902200 /02AC Barco Demetra Cleaning and disinfection 7 K5902200 /02AC Barco Demetra 41 Cleaning and disinfection label Isopropyl alcohol <70%
for disinfection. Read and follow all 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 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. Do not use abrasive material on any part of the equipment or immerse the device in liquid. Do not autoclave. The following products can be used for disinfection:
Disinfection products:
Clinell wipes Cleaning agent: Neodisher MediClean Disinfection products based on following substances:
Ethanol based < 90%
To clean the contact glass of the Demetra Scope The contact glass should be treated as high quality photographic equipment and should be cleaned with standard cleaning equipment and protected from harmful chemicals. To clean the display of the Demetra Scope Clean the display using a sponge, cleaning cloth or soft tissue, lightly moistened with a recognized cleaning product for medical equipment. Read and follow all label instructions on the cleaning product. In case of doubt about a certain cleaning product, use plain water. Do not use following products:
Alcohol/solvents at higher concentration > 5%
Strong alkalis (lye), strong solvents Highly acidic detergents Detergents with fluoride Detergents with ammonia Detergents with abrasives Steel wool Sponge with abrasives Steel blades Cloth with steel thread CAUTION: Take care not to damage or scratch the display. Be careful with rings or other jewelry and do not apply excessive pressure on the display. CAUTION: Do not apply or spray liquid directly to the display as excess liquid may cause damage to internal electronics. Instead, apply the liquid to a cleaning cloth. 42 K5902200 /02AC Barco Demetra Important information 8 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. K5902200 /02AC Barco Demetra 43 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. 60601-1: 14 (Label UL Mark) To prevent electric shock or fire hazard, do not remove cover. No serviceable parts inside. Refer servicing to qualified personnel. Do not expose this apparatus to rain or moisture. Make sure the electrical contacts of the grip / battery pack and battery charging station are dry and clean to avoid short circuit. Keep the On/Off button on top of the head pressed to safely shut down the Demetra Scope. Modifications to the unit Do not modify this equipment without authorization of the manufacturer. Inspection and maintenance Inspect the display and contact glass of the Demetra Scope for damage or scratches at regular intervals. Propely clean and disinfect the Demetra Scope. See Cleaning and disinfection, page 41 for more details. Type of protection (electrical):
The Demetra Scope has an insulation protection class II power supply adapter. Power connection Power requirements: The equipment must be powered using the delivered adapter and appropriate plug
(for your country). The adapter must be powered by the AC mains voltage. The power supply is specified as a part of the ME equipment or combination is specified as a ME system. The equipment should be installed near an easily accessible outlet. The equipment is intended for continuous operation. Disconnecting the adapter from the building mains outlet is the proper means of isolation from the mains supply. 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. Transient over-voltage If the device is not used for a long time, remove it from the battery charger to avoid damage by transient over-
voltage. To fully disengage the power to the device, please remove it from the battery charger. 44 K5902200 /02AC Barco Demetra 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. Never use the device near water - e.g. near a bathtub, washbasin, swimming pool, kitchen sink, laundry tub or in a wet basement. 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. The Demetra Scope is not intended to be used for lesions in the eyes. Do not stare at operating lamp. May be harmful to the eyes. Product tested against IEC62471. Glass temperature The temperature of the contact glass can reach 46.5 C. Please verify the temperature of the contact glass and the condition of the patient before using contact mode. Limit the contact duration to less than 1 minute, or use non-contact mode instead. Breached or compromised surface Avoid contact between the Demetra Scope and breached or compromised surfaces, even when the non-
contact cone is installed. In case of large breached or compromised lesions, do not use the non-contact cone. Make sure to keep appropriate distance between the Demetra Scope head and the lesion. Risk patients As the Demetra Scope contains several magnets (for the attachment of the non-contact cone and for the installation in the battery charging station), pay attention when examining specific risk patients (e.g. patients with a pacemaker, ...). Malfunctions Contact the Barco helpdesk under the following conditions:
If the power cord or plug is damaged or frayed. If liquid has been spilled into the equipment. If the equipment has been exposed to rain or water. If the equipment does not operate normally when the operating instructions are followed. Adjust only those controls that are covered by the operating instructions since improper adjustment of other controls may result in damage and will often require extensive work by a qualified technician to restore the equipment to normal operation. If the equipment has been dropped or has been damaged. If the equipment exhibits a distinct change in performance, indicating a need for service. Technical data For detailed information, see Technical specifications, page 56. K5902200 /02AC Barco Demetra 45 Important information National Scandinavian Deviations for CL. 1.7.2 Finland: "Laite on liitettv suojamaadoituskoskettimilla varustettuun pistorasiaan"
Norway: "Apparatet m tilkoples jordet stikkontakt"
Sweden: "Apparaten skall anslutas till jordat uttag"
8.2 Environmental information Disposal Information Waste Electrical and Electronic Equipment This symbol on the product indicates that, under the European Directive 2012/19/EU governing waste from electrical and electronic equipment, this product must not be disposed of with other municipal waste. Please dispose of your waste equipment by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate these items from other types of waste and recycle them responsibly to promote the sustainable reuse of material resources. For more information about recycling of this product, please contact your local city office or your municipal waste disposal service. For details, please visit the Barco website at: http://www.barco.com/AboutBarco/weee 8.3 Regulatory compliance information Regulatory e-labeling information can be found on the Demetra Scope (Mains screen > click Wifi logo > 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 AT EE IT PT BE FI LV RO BG FR LT SK HR DE LU SI CY EL MT ES CZ HU NL SE DK IE PL UK 2.4 GHz band: 20 dBm 5 GHz band: 20 dBm The device is restricted to indoor use only when operating in the 5150 to 5350 MHz frequency range. WiFi maximum EIRP power:
8.3.2 FCC statement FCC ID This device is registered under FCC ID SXE-BDEM01. 46 K5902200 /02AC Barco Demetra Important information Increase the separation between the device and receiver. 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to radio or television reception, which can be determined by turning the device off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Connect the device into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. 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 Radiation exposure statement The product complies with the FCC portable RF exposure limit set forth for an uncontrolled environment and are safe for intended operation as described in this manual. The further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such function is available. These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue. The highest SAR value reported under this standard during product certification for use when properly worn on the body is 0.820 W/
kg. 8.3.3 Industry Canada statement - Avis d'industrie Canada IC This device is registered under IC 9393B-BDEM01. Cet appareil est enregistr sous IC 9393B-BDEM01. ICES - NMB This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numrique de la classe B est conforme la norme NMB-003 du Canada. ISED This device complies with ISED license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR d' ISED applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et
(2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. Permitted frequency ranges - Gamme de frquences autorise Operations in the 5.25-5.35 GHz band are restricted to indoor usage only. Les oprations dans la bande de 5.25-5.35 GHz sont limits un usage intrieur seulement. Operation in the band 5150-5250 MHz is only for indoor use to reduce the potential for harmful interference to co-channel mobile satellite systems. K5902200 /02AC Barco Demetra 47 Important information La bande 5 150-5 250 MHz est rservs uniquement pour une utilisation l'intrieur afin de rduire les risques de brouillage prjudiciable aux systmes de satellites mobiles utilisant les mmes canaux. For the frequency 5600-5650 MHz, no operation is permitted. Pour la frquence 5600-5650 MHz, aucune opration est autorise. Radiation exposure statement These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue. The highest SAR value reported under this standard during product certification for use when properly worn on the body is 1.148 W/
kg. Ces exigences tablissent une limite SAR de 1,6 W/kg en moyenne sur un gramme de tissu. La valeur SAR la plus leve dclare selon cette norme lors de la certification du produit utiliser lorsqu'il est correctement port sur le corps est de 1.148 W/kg. 8.3.4 General information Manufacturing country The manufacturing country of the product is indicated on the product label (Made in ). Importers contact information To find your local importer, contact one of Barcos regional offices via the contact information provided on our website (www.barco.com). 8.4 EMC notice 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. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 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. Electromagnetic emissions 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. Emissions test RF emissions CISPR 11 Compliance Group 1 Electromagnetic environment Guidance The Demetra solution uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Demetra solution is suitable for use in all establishments, including RF emissions CISPR 11 Class B 48 K5902200 /02AC Barco Demetra Important information Complies Compliance Class A Electromagnetic environment Guidance domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic purposes. Emissions test Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 This Demetra solution complies with appropriate medical EMC standards on emissions to, and interference from surrounding equipment. 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. Interference can be determined by turning the equipment off and on. If this equipment does cause harmful interference of, surrounding equipment, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna or equipment. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 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. Immunity test Electrostatic discharge
(ESD) IEC 61000-4-2 Compliance level 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air IEC 60601 test levels 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Increase the separation between the equipment and receiver. interference to, or suffer from harmful Electrical fast transient/
burst IEC 61000-4-4 Surge IEC61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 2 kV for power supply lines 1 kV for input/ output lines 100 kHz repetition frequency Line to line: 0.5 kV, 1 kV Line to ground: 0.5 kV, 1 kV, 2 kV 0% residual voltage for 0.5 period at 0, 45, 90, 135, 180, 225, 270 and 315 0% residual voltage for 1 period at 0 70% residual voltage for 25 periods at 0 Voltage interruptions: 0%
residual voltage for 250 periods at 0 2 kV for power supply lines 1 kV for input/ output lines 100 kHz repetition frequency Line to line: 0.5 kV, 1 kV Line to ground: 0.5 kV, 1 kV, 2 kV 0% residual voltage for 0.5 period at 0, 45, 90, 135, 180, 225, 270 and 315 0% residual voltage for 1 period at 0 70% residual voltage for 25 periods at 0 Voltage interruptions: 0%
residual voltage for 250 periods at 0 Power frequency (50/60 Hz) magnetic field 30 A/m Not applicable 1 1: Demetra solution doesnt contain susceptible components to magnetic fields Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment. If the user of the Demetra solution requires continued operation during power mains interruptions, it is recommended that the Demetra solution be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be K5902200 /02AC Barco Demetra 49 Important information Immunity test IEC 61000-4-8 Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 test levels Compliance level 3 Vrms (6 Vrms in ISM bands) 150 kHz to 80 MHz 3 V/m 80 MHz to 2.7 GHz 3 Vrms (6 Vrms in ISM bands) 3 V/m Electromagnetic environment guidance at levels characteristic of a typical location in a typical commercial or hospital environment
-
Immunity to RF wireless communications equipment Band (MHz) Service Modulation Maximum power (W) Distance
(m) Test frequency
(MHz) 385 450 710 745 780 810 870 930 1720 1845 1970 380 390 TETRA 400 430 470 GMRS 460, FRS 460 704 787 LTE Band 13, 17 800 960 1700 1990 GSM 800/
900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800, CDMA 1900, GSM 1900, DECT, LTE Band 1/3/4/
25, UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 W LAN 802.11 a/n Pulse modulation 18 Hz FM 5 kHz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz 1.8 2 0.2 2 2 2 0.2 0.3 0.3 0.3 0.3 0.3 0.3 0.3 2450 2400 2570 5100 5800 5240 5500 5785 Immunity test level (V/
m) 27 28 9 28 28 28 9 8.5 Explanation of symbols Symbols on the device On the device or power supply, you may find the following symbols (nonrestrictive list):
50 K5902200 /02AC Barco Demetra 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. 6060-1 (2014) Indicates the device is approved according to the UL regulations for Canada and US Indicates the device is approved according to the UL regulations for Canada and US Indicates the device is approved according to the UL Demko regulations Indicates the device is approved according to the CCC regulations Indicates the device is approved according to the VCCI regulations Indicates the device is approved according to the KC regulations Indicates the device is approved according to the BSMI regulations Indicates the device is approved according to the PSE regulations Indicates the device is approved according to the EAC regulations 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 51 E352529S&E Important information Indicates the legal manufacturer Indicates the manufacturing date Indicates the temperature limitations2 for the device to safely operate within specs 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 (Waste Electrical and Electronic Equipment) directive Indicates Direct Current (DC) Indicates Alternating Current (AC) Stand-by Equipotentiality Protective earth (ground) or Symbols on the box On the box of the device, you may find the following symbols (nonrestrictive list):
2:
Values for xx and yy can be found in the technical specifications paragraph. 52 K5902200 /02AC Barco Demetra yyxxSNREFREV 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. Indicates that the box should be carried with two persons. Indicates that the box should not be cut with a knife, a cutter or any other sharp object. Indicates the temperature limits to which the medical device can be safely exposed when being stored. Indicates the range of humidity to which the medical device can be safely exposed when being stored. Indicates the range of atmospheric pressure to which the medical device can be safely exposed when being stored. 8.6 Explanation of icons Overview Settings Device Add/remove digital scale Delete image Battery status: full Save image Battery status: empty Compare images K5902200 /02AC Barco Demetra 53 15nxx-yy Kg-20 C+60 Cxxyy85 %5 %xyy106 kPa50 kPaxxyyy 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:
synchronizing Edit mode for lesion markers (add/edit/
remove) Cloud connection indicator:
synchronizing error Add new marker Patient Physician (user) Edit Undo Admin user Rotate clockwise Physician-admin user Rotate counterclockwise Delete physician (user) Report 54 K5902200 /02AC Barco Demetra Switch patient Generate report Important information Image gallery Mannequin view of image gallery Localize on mannequin View report Zoom in Hierarchical view of image gallery Zoom out Chronological view of image gallery Pan Switch image mode Dermoscopic mode Notification Warning Close-up mode Image swap (select image) Overview mode (to capture an image) Localize on clinical overview Lock rotation Switch camera (in close-up mode) Lock pan Overlay Lock zoom Polarized/non-polarized image Show legal information Brightness low Brightness full Autofocus K5902200 /02AC Barco Demetra 55 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., 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. The specifications of Barco products are subject to change without notice. Trademarks All trademarks and registered trademarks are property of their respective owners. Copyright notice This document is copyrighted. All rights are reserved. Neither this document, nor any part of it, may be reproduced or copied in any form or by any means - graphical, electronic, or mechanical including photocopying, taping or information storage and retrieval systems - without written permission of Barco. 2019 Barco NV all rights reserved. Patent protection Please refer to www.barco.com/about-barco/legal/patents 8.8 Technical specifications Overview Internal camera Secondary camera Multispectral LEDs for dermoscopic images 3840 (H) x 2160 (V), aspect ration 16:9 3264 (H) x 1836 (V), aspect ration 16:9 Amber Deep Red Green Cyan Blue Royal Blue Far Red Red-Orange 6500K AMOLED, 1920 (H) x 1080 (V), aspect ration 16:9, capacitive touchscreen Wi-Fi 802.11 a/b/g/n/ac 5V 3A Lithium-Cylindrical Battery of capacity 5000mAh
(typical) Lithium battery of capacity 2670mAh (typical) Renol-White White LEDs for live video preview Screen technology Wireless communication Input rating Battery in grip Battery in head Housing color 56 K5902200 /02AC Barco Demetra Dimensions scope (head + grip mounted) (H x W x D) Dimensions packaged (D x W x H) Net weight scope (head + grip mounted) Net weight packaged (box with all parts included) Operating temperature range Storage temperature Operating humidity Storage humidity Operating pressure Storage pressure Certifications Important information 231 x 143 x 78 mm 347 x 260 x 150 x mm Without noncontact cone: 528 g With noncontact cone: 552 g 2.2 kg 0C to 35C
-20 C to 60 C Maximum 85% non-condensing Maximum 95% non-condensing 70 kPa minimum 60 to 106 kPa CE (MDD 93/42/EEC; A1:2007/47/EC class I device) Safety:
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
@@@
RF:
Radio Equipment Directive 2014/53/EU K5902200 /02AC Barco Demetra 57 K5902200 /02AC | 2019-09-09 Barco NV | Beneluxpark 21, 8500 Kortrijk, Belgium Registered office: Barco NV | President Kennedypark 35, 8500 Kortrijk, Belgium www.barco.com Barco NVPresident Kennedypark 358500 KortrijkBelgium K5902200-02
1 2 | External Photos | External Photos | 927.32 KiB | April 10 2019 / May 10 2019 |
Test report No. Page Issued date
: 4788637943-EP
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: Sep. 18, 2019 Product Photos External Photos Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
:+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. Page Issued date
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: Sep. 18, 2019 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
:+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. Page Issued date
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: Sep. 18, 2019 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
:+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. Page Issued date
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: Sep. 18, 2019 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
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: Sep. 18, 2019 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
:+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. Page Issued date
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: Sep. 18, 2019 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
:+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948
1 2 | Internal Photos | Internal Photos | 2.99 MiB | April 10 2019 / May 10 2019 |
Test report No. Page Issued date
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: Sep. 18, 2019 Internal Photos Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
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: Sep. 18, 2019 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
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: Sep. 18, 2019 Antenna Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
:+886-2-7737-3000 Facsimile (FAX ) :+886-3-583-7948 Test report No. Page Issued date
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: Sep. 18, 2019 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
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: Sep. 18, 2019 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
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: Sep. 18, 2019 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
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: Sep. 18, 2019 Underwriters Laboratories Taiwan Co., Ltd. Building B and Building E, No. 372-7, Sec. 4, Zhongxing Rd., Zhudong Township, Hsinchu County, Taiwan Telephone
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frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-10-05 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
2 | 5745 ~ 5825 | NII - Unlicensed National Information Infrastructure TX |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2019-10-05
|
||||
1 2 | Applicant's complete, legal business name |
Barco N.V.
|
||||
1 2 | FCC Registration Number (FRN) |
0027154087
|
||||
1 2 | Physical Address |
President Kennedypark 35, Kortrijk 8500, Belgium
|
||||
1 2 |
Kortrijk, N/A
|
|||||
1 2 |
Belgium
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
L******@ul.com
|
||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
SXE
|
||||
1 2 | Equipment Product Code |
BDEM01
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
E******** C****
|
||||
1 2 | Title |
RD Manager Hardware
|
||||
1 2 | Telephone Number |
+32-5********
|
||||
1 2 | Fax Number |
+32-5********
|
||||
1 2 |
e******@barco.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | NII - Unlicensed National Information Infrastructure TX | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Skin scanner-Lumos | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Listed output power is peak conducted. This device supports 802.11n with a 20 MHz and 40 MHz bandwidth. This device also supports 802.11b and 802.11g with a 20MHz bandwidth. SAR compliance for body-worn operating configurations is limited to the specific configurations tested for this filing. Body-worn operations are restricted to belt-clips, holsters or similar accessories that have no metallic component in the assembly. End-users must be informed of the body-worn operating requirements for satisfying RF exposure compliance. The highest reported SAR values for body-worn accessory is 0.06W/kg. | ||||
1 2 | Output power listed is maximum conducted. This device supports 802.11n with a 20 MHz and 40 MHz bandwidth mode and 802.11ac with a 20MHz, 40MHz and 80MHz bandwidth mode. This device also supports 802.11a with a 20 MHz bandwidth. SAR compliance for body-worn operating configurations is limited to the specific configurations tested for this filing. Body-worn operations are restricted to belt-clips, holsters or similar accessories that have no metallic component in the assembly. End-users must be informed of the body-worn operating requirements for satisfying RF exposure compliance. The highest reported SAR for body-worn accessory is 0.82W/kg. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
Underwriters Laboratories Taiwan Co., Ltd.
|
||||
1 2 | Name |
R**** C****
|
||||
1 2 | Telephone Number |
886-2********
|
||||
1 2 | Fax Number |
+886-********
|
||||
1 2 |
R******@ul.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.0843000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15E | 5180 | 5240 | 0.0431 | ||||||||||||||||||||||||||||||||||||
2 | 2 | 15E | 5260 | 5320 | 0.0426 | ||||||||||||||||||||||||||||||||||||
2 | 3 | 15E | 5500 | 5700 | 0.0486 | ||||||||||||||||||||||||||||||||||||
2 | 4 | 15E | 5745 | 5825 | 0.05 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC