Barco BDEM-01 Скачать руководство пользователя страница 60

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K5902200 /07

Barco Demetra

Indicates the legal manufacturer

Indicates the manufacturing date

Indicates the temperature limitations

for the device to safely operate within specs

Indicates this is a Medical Device.

Indicates the device serial number.

REF

Indicates the device part number or catalogue number.

UDI

Indicates the Unique Device Identifier.

REV

Revision of the part number or catalogue number

Warning

: dangerous voltage

Caution

Consult the Instructions For Use.

eIFU indicator

Consult the Instruction For Use on website address that is provided as eIFU indicator.

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

Important information

Values for xx and yy can be found in the technical specifications paragraph.

Содержание BDEM-01

Страница 1: ...ENABLING BRIGHT OUTCOMES BDEM 01 User Guide Barco Demetra...

Страница 2: ...Registered office Barco NV President Kennedypark 35 8500 Kortrijk Belgium www barco com en support www barco com Barco NV Beneluxpark 21 8500 Kortrijk Belgium www barco com en support www barco com...

Страница 3: ...n 15 2 2 6 Settings user 16 2 2 7 About Demetra 17 2 3 Installation of Demetra Scope 17 2 3 1 Installation of the grip battery pack 17 2 3 2 Removal of the grip battery pack 18 2 3 3 Installation of t...

Страница 4: ...oting instructions 40 6 Repacking instructions 43 6 1 Repacking overview 44 7 Cleaning and disinfection 47 7 1 Instructions 48 8 Important information 49 8 1 Safety information 50 8 2 Environmental in...

Страница 5: ...tion 7 1 3 What s in the box 7 1 4 Demetra Scope 8 1 5 Demetra Web Application 9 1 6 Analytics Toolkit 9 Refer to www barco com support demetra docs for the latest version and translations of this Use...

Страница 6: ...arding a certain skin condition Intended part of the body or type of tissue applied to or interacted with The device can be used on the following body parts Skin Nails Hair The device should not be us...

Страница 7: ...y of 3 6 hours continuous operation Rechargeable and replaceable grip battery pack Demetra Web Application for viewing captured images and photographs Primary camera for multispectral dermoscopic imag...

Страница 8: ...arged batteries 20 Steady orange Batteries low 20 Slow blinking green Batteries charging when the device is placed in the battery charging station Steady green Batteries fully charged when the device...

Страница 9: ...s for analyzing white light and or multispectral dermoscopic images captured with the Demetra Scope Those tools allow to clearly visualize specific skin structures such as primarily pigment distributi...

Страница 10: ...K5902200 07 Barco Demetra 10 Welcome...

Страница 11: ...a 2 1 Minimum system requirements 12 2 2 Setup of Demetra Web Application 12 2 3 Installation of Demetra Scope 17 2 4 Setup of Demetra Scope 20 2 5 When the Demetra subscription is terminated 22 Insta...

Страница 12: ...ake sure to have the latest updates of your web browser installed and to have an up to date virus scanner running at all times Display resolution For an adequate viewing experience we recommend to use...

Страница 13: ...er to Configuration user page 14 2 2 2 Configuration admin Admin After user authentication as admin see Activation page 12 select the desired account language and click Start configuration on the Deme...

Страница 14: ...m The following settings can be adapted Device authentication Select your desired device authentication method pin code or no authentication depending on the account settings see Settings admin page 1...

Страница 15: ...laboration requests shared with you 2 2 5 Settings admin Admin When logged in as admin click your name at the top of the screen in the Demetra Web Application and select Admin settings The following t...

Страница 16: ...dual x 509 certificates client or CA certificate with crt extension or an entire PKCS 12 certificate chain p12 or pfx extension 4 Set up the network connection on your onboarded Demetra Scope using th...

Страница 17: ...ur name at the top of the screen in the Demetra Web Application and select About Demetra This page shows medical device information for BDEM 01 e g model name part number and software versions and the...

Страница 18: ...g ring of the grip to the right direction of the locking symbol until it softly clicks into the locked position Caution Only turn the locking ring of the grip not the entire grip itself Image 2 7 2 3...

Страница 19: ...the entire grip itself Image 2 9 3 Remove the grip from the Demetra Scope head Image 2 10 It may be needed to firmly pull the grip to separate it from the Demetra Scope head 2 3 3 Installation of the...

Страница 20: ...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 accessibl...

Страница 21: ...nces screen tap Install from storage 9 The WiFi certificates that were uploaded in the Demetra Web Application should be visible in the Choose a certificate screen 10 Install the certificates and navi...

Страница 22: ...ss to all data available in the Demetra Web Application beyond the 60 day period after termination of the regular Demetra Customer subscription you can subscribe to the Demetra Extended License 5 If y...

Страница 23: ...1 Start the Demetra Scope 24 3 2 Basic workflow 24 3 3 Live video preview 25 3 4 Image detail screen 26 3 5 Localize on clinical overview 27 3 6 User entry of diagnosis and management strategy 27 Oper...

Страница 24: ...ither with the default secondary camera more than 10 cm from the skin or with the primary camera up to 5 10 cm from the skin see Live video preview page 25 Overview mode to capture a clinical overview...

Страница 25: ...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 With the Demetra Scope dermoscopic ima...

Страница 26: ...nalytics Toolkit user guide tool not available in all markets 4 Localize Allows to localize a dermoscopic or close up image on an overview photograph or on a dummy mannequin 5 Compare the selected ima...

Страница 27: ...entative diagnosis from the predefined list Note that the device does not automatically suggest this tentative diagnosis 2 It is not possible to select a user defined pathology proven diagnosis on the...

Страница 28: ...llow up Yellow Treatment Orange Excision or biopsy Red Excision or biopsy finished Blue Lesion markers on the dummy mannequin or on a clinical overview photograph are displayed in the color of the use...

Страница 29: ...on 30 4 2 Main menu 30 4 3 Patient detail screen 31 4 4 Consultations screen 33 4 5 Image detail screen 33 4 6 User entry of diagnosis and management strategy 36 4 7 Reports 36 4 8 Sharing patient dat...

Страница 30: ...you through the configuration procedure When logged in as admin see Configuration admin page 13 When logged in as regular user see Configuration user page 14 When logged in as guest user see Configura...

Страница 31: ...n requests shared with you by other Demetra users or that you have shared with other medical professionals including non Demetra users See Sharing patient data Collaboration page 37 for more details o...

Страница 32: ...rwise the tentative diagnosis is used Management This filter allows to show all images with one of the selected management strategies as assigned by the user Image type This filter allows to show all...

Страница 33: ...consultation can be created see Reports page 36 Generate a new collaboration request A collaboration request of the consultation can be created see Sharing patient data Collaboration page 37 3 Current...

Страница 34: ...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 6 Image captured with or without the non c...

Страница 35: ...ph 7 Analyze When available in your country please refer to the Analytics Toolkit User Guide 8 Diagnose see User entry of diagnosis and management strategy page 36 for more information 9 Pan the image...

Страница 36: ...ndefined Grey No follow up or treatment Green Follow up Yellow Treatment Orange Excision or biopsy Red Excision or biopsy finished Blue Lesion markers on the dummy mannequin or on a clinical overview...

Страница 37: ...request Image 4 8 After having selected a patient the Consultations tab is opened Under the appropriate consultation date click Collaboration request in the dropdown menu under Generate report Image 4...

Страница 38: ...t information in the Demetra Web Application after completing a limited guest user onboarding procedure for first time users see Configuration guest user page 14 or after login for existing users The...

Страница 39: ...07 Barco Demetra 5 1 Troubleshooting instructions 40 Contact the Barco helpdesk via www barco com support demetra Log a service ticket or find the email address and phone number for your country Troub...

Страница 40: ...tation 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 Data synchronization error U...

Страница 41: ...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 The Cus...

Страница 42: ...K5902200 07 Barco Demetra 42 Troubleshooting...

Страница 43: ...43 K5902200 07 Barco Demetra 6 1 Repacking overview 44 Repacking instructions 6...

Страница 44: ...w Overview 1 2 3 5 4 6 7 8 9 11 10 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...

Страница 45: ...45 K5902200 07 Barco Demetra 11 Plugs Repacking instructions...

Страница 46: ...K5902200 07 Barco Demetra 46 Repacking instructions...

Страница 47: ...47 K5902200 07 Barco Demetra 7 1 Instructions 48 Cleaning and disinfection 7...

Страница 48: ...aphic 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...

Страница 49: ...nmental information 52 8 3 Regulatory compliance information 52 8 4 Integration of Demetra in IT networks 54 8 5 EMC notice 56 8 6 Explanation of symbols 58 8 7 Explanation of icons 61 8 8 Legal discl...

Страница 50: ...uipment 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 Properly clean and...

Страница 51: ...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 t...

Страница 52: ...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 sustainab...

Страница 53: ...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 responsib...

Страница 54: ...tiliser lorsqu il est correctement port sur le corps est de 1 148 W kg 8 3 4 General information Notice to the user and or patient Any serious incident that has occurred in relation to the device shou...

Страница 55: ...This workstation should be equipped with a high speed preferably wired ethernet connection with the same bandwidth and connection options specified for the Demetra Scope A strong password policy and...

Страница 56: ...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 equi...

Страница 57: ...ne 0 5 kV 1 kV Line to ground 0 5 kV 1 kV 2 kV Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power suppl...

Страница 58: ...modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 2 0 3 28 5240 5100 5800 W LAN 802 11 a n Pulse modulation 217 Hz 0 2 0 3 9...

Страница 59: ...ing 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 accordi...

Страница 60: ...tifier REV Revision of the part number or catalogue number Warning dangerous voltage Caution Consult the Instructions For Use eIFU indicator Consult the Instruction For Use on website address that is...

Страница 61: ...y status full Close Battery status empty Compare images Battery issue contact Barco helpdesk Analyze WiFi error offline Generate Lesion Analytics WiFi status full strength Toggle visualization of Lesi...

Страница 62: ...r Take new image Offline No localization Patient Edit mode for lesion markers add edit remove Physician user Add new marker Admin user Edit Physician admin user Undo Reset Retry Delete physician user...

Страница 63: ...itch image Maximize Dermoscopic mode Minimize Close up mode Report Overview mode to capture an image Localize on clinical overview Generate report Switch camera in close up mode View report Overlay Do...

Страница 64: ...ny 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 perm...

Страница 65: ...ged D x W x H 347 x 260 x 150 x mm Net weight scope head grip mounted Without non contact cone 540 g With non contact cone 564 g Net weight packaged box with all parts included 2 2 kg Operating temper...

Страница 66: ...K5902200 07 Barco Demetra 66 Important information...

Страница 67: ......

Страница 68: ...www barco com K5902200 07 2021 11 04 Barco NV President Kennedypark 35 8500 Kortrijk Belgium K5902200 07...

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