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User Manual

DICOM Camera

V

EU DECLARATION OF CONFORMITY

For medical products according to regulation (EU) 2017/745

Manufacturer:

meso international GmbH

Markt 21 – 23

09648 Mittweida

Deutschland

Single Registration Number (SRN): (TBA)

Product Description:

Product group:

DICOM Camera

Basic-UDI-DI:

426033676-DC-Y4

Models:

DC-CPB – DICOM Camera Pro

DC-CC – DICOM Camera Compact

DC-CC2 – DICOM Camera Compact 2

Intended purpose:

Recording, temporary storage and transfer of
photographic medical images and video

GMDN:

58857 - Multi-purpose digital medical camera

Classification:

Class I device according to Annex VIII, rule 10 and rule 13 of MDR (EU) 2017/745

Statement:

meso international GmbH assumes sole responsibility for issuing this EU Declaration of
Conformity.

The conformity assessment was carried out in accordance with Annex IV of MDR (EU)
2017/745.

Applied Specifications:

EN ISO 13485:2016

Medical devices

—

Quality management systems

EN ISO 14971

Application of risk management to medical devices

EN 62304

Medical device software

—

Software life cycle processes

EN 60601-1

Medical Electrical Equipment

EN 60601-1-4

Programmable electrical medical systems

EN 60950-1:2006+A11:2009+A1:2010+A12:2011, EN 50332-2:3003, EN 300 328 V1.7.1, EN 300 440-1
V1.6.1, EN 300 440-2 V1.4.1, EN 301 893 V1.6.1, EN61000-3-2:2006+A1:2009+A2:2009, EN61000-3-
3:2008, EN 301 489-1 V1.9.2, EN 301 489-1 V2.2.1, EN 301 489-3 V1.6.1, EN 302 291-1 V1.1.1, EN 302 291-
2 V1.1.1, EN62311:2008, EN 55024:2010, EN 55022:2010/AC:2011

Mittweida, 2020-04-01

Place, Datum

Dipl.-Math. Christian Schwerin

Managing Director / Responsible person according to MDR, Art. 15

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Содержание DC-CC

Страница 1: ...DICOM CAMERA DICOM Camera User Manual Version 2 4 0 1995 2020 meso international GmbH All rights reserved ...

Страница 2: ... pertain to features that are optional and can only be used if the respective software options were previously purchased The presence of the corresponding descriptions in this manual does not establish any rights of the software user whatsoever to be provided with these options unless they are lawfully purchased DICOM Camera as well as all other MESO and DICOM Camera logos are registered trademark...

Страница 3: ...ns of acts that could lead to serious problems to the complete system failure or to misdiagnoses and thus in patients to mistreatment and worst of all to death ATTENTION Actions that can t be undone Manufacturer SN serial number Indicates the computer keyboard keys for example Ctrl Indicates buttons on the user interface e g OK for Italic Formatting for controls in the interface e g menu items or ...

Страница 4: ...DICOM Camera IV DC EN 240F DICOM CAMERA MODELS The following codes and names are used for the individual camera models DC CC DICOM Camera Compact DC CC2 DICOM Camera Compact 2 DC CPB DICOM Camera Pro ...

Страница 5: ...for issuing this EU Declaration of Conformity The conformity assessment was carried out in accordance with Annex IV of MDR EU 2017 745 Applied Specifications EN ISO 13485 2016 Medical devices Quality management systems EN ISO 14971 Application of risk management to medical devices EN 62304 Medical device software Software life cycle processes EN 60601 1 Medical Electrical Equipment EN 60601 1 4 Pr...

Страница 6: ...Select operator and performing physician 6 2 3 1 Select operator 6 2 3 2 Enter operator PIN 7 2 3 3 Change operator 7 2 3 4 Logout operator 8 2 3 5 Select performing physician 8 2 4 Worklist 9 2 4 1 Pinned exams 10 2 4 2 Add exam manually 11 2 4 3 Sent history 13 2 5 Scan admission ID and supplement with patient data via HL7 14 2 6 Capture images and videos Capture mode 16 2 6 1 Display of patient...

Страница 7: ... Fi and network 33 3 1 1 Configure SSID and security 34 3 1 2 Configure static IP address 35 3 2 Configure DICOM Camera Server 37 3 3 Install certificate 38 3 4 Power Fast Start up Auto power off 40 3 5 Display 41 3 5 1 Sleep Standby 42 4 WEBVIEWER 43 4 1 1 Open Webviewer 43 4 1 2 Find patients 43 4 1 3 View images 44 4 1 4 Change Webviewer password 45 5 CAMERA MAINTENANCE 46 5 1 Battery 46 5 1 1 ...

Страница 8: ......

Страница 9: ...to charge the camera during use an AC adapter certified according to EN 60601 1 is required Such a power supply can be ordered separately ATTENTION The DICOM Camera corresponds to the basic requirements of Annex I of the Medical Device Directive 93 42 EEC Therefore all functions of the camera which go beyond photography have been blocked While trying to execute a blocked function a corresponding m...

Страница 10: ...d hold power button until the display turns on ATTENTION Wait until the camera has fully booted It is ready for operation after the operator selection or work list has been displayed Previously created recordings are deleted because they cannot be assigned to a patient Turning on a camera can take up to a minute Power off Press and hold power button until a menu is shown Select Power off Confirm t...

Страница 11: ... bar The status bar provides information on the current state of the camera Tap and hold the bottom area of a status icon to learn more Fig 3 Typical icons of the status bar 2 2 1 Operators A separate icon is displayed for each operator of the camera Its individual appearance depends on the user alias DICOM entered in the DICOM Camera Server In addition to the symbol the operator s initial letter ...

Страница 12: ...details and to modify server s IP address 2 2 3 Wi Fi The DICOM Camera receives and transmits data via Wi Fi A stable Wi Fi connection is a requirement to successfully work with the DICOM Camera Connected best reception Connected low reception no Wi Fi connection Tap long on the bottom area of the symbol to get more details and to modify Wi Fi settings 2 2 4 Storage usage Image and video recording...

Страница 13: ... to display more details and to change time and date ATTENTION Always ensure that the time is set correctly Incorrect date and time settings may cause serious problems including loss of recordings If possible configure your network so that the cameras except DC CC can retrieve the current time from the NTP time server 2 android pool ntp org and leave the setting Obtain time automatically except DC...

Страница 14: ...e performing physician is the responsible person for the examination or image documentation That person appears in the DICOM tag PerformingPhysicianName 0008 1050 of each capture A user can simultaneously be a physician and operator Which category a user belongs to is specified in the DICOM Camera Server NOTE The user profiles are managed in the DICOM Camera Server see the user manual of the DICOM...

Страница 15: ...red in DICOM Camera Server to control the access to the camera If no PIN has been configured you will be taken directly to the worklist after selection Fig 6 Enter PIN 2 3 3 Change operator Tap long on the bottom area of the symbol to display the current operator s name and to change the operator see also section 2 3 1 ...

Страница 16: ...ff in standby immediately or some minutes afterwards This means that the camera can also be put into standby during an examination without requiring a new login See user manual of DICOM Camera Server chapter Manage users 2 3 5 Select performing physician The selection of the performing physician is displayed for the following events An examination without specified physician has begun Physician is...

Страница 17: ...reen A refresh can be triggered manually by pulling down the list or via Refresh The worklist can be displayed horizontally or vertically depending on the orientation of the camera Below the date the patient s location is displayed if supplied by your HIS or entered manually Each worklist entry starts with an icon symbolizing the patient s sex Female Male Other Not specified Tap the desired examin...

Страница 18: ... time based on the same order Pinned exams display a pin symbol and an orange bar on the right edge Whether or not an exam is pinned is controlled by its study description See manual of DICOM Camera Server section Enter study descriptions A pinned examination is only completed when you mark the examination as finished To do this tap the orange bar or swipe left Fig 10 Unpin long term examination A...

Страница 19: ...ADT or created manually in the camera First name Last name Birthdate Sex Patient ID Accession number Admission ID Reason for requested procedure Study description Location In the worklist tap on to open the form to create a new exam Scroll through the form with wipe Fig 11 Form to add exam Scan an admission ID with ...

Страница 20: ...button to start the exam is only enabled after correct input Fig 13 Button to start exam with and without textual description Tap on the line you want to change A virtual keyboard opens in the horizontal view In the vertical view the keyboard is displayed in fullscreen Fig 14 Appearance of virtual keyboard based on screen rotation Jump to next field with Next or Close the keyboard with or Tap Star...

Страница 21: ...Sent history You can track which captures were successfully sent by the camera in the last 8 days even if the respective entries are no longer in the worklist Only information relevant for troubleshooting is displayed In the work list tap or Tap Sent history A list of all successfully sent recordings of the last 8 days appears Fig 17 Sent history ...

Страница 22: ...f scanning See manual of DICOM Camera Server section Configure HL7 Start an exam by scanning the barcode containing the patient s admission ID Direct the camera towards the barcode Click only now or press the camera s shutter button Fig 18 Scan icon A window opens to scan the barcode The barcode should be within the green frame Fig 19 Scan admission ID Keep the barcode in focus for a moment The ca...

Страница 23: ...ent data is retrieved via HL7 New exam is created and started Doesn t contain exams with the scanned admission ID and HL7 did not return patient data Also occurs if camera is offline while HL7 Offline mode is disabled a Form containing the scanned admission ID appears to create exam manually see section 2 4 2 b Last name is _emergency_DC current time e g _emergency_DC_15 13 30 c Patient ID is YYYY...

Страница 24: ...on otherwise the recording will be lost Fig 20 Successful image capture confirmed by green frame 2 6 1 Display of patient data in capture mode The DICOM Camera ensures that the current patient is always displayed in the recording mode to support the correct assignment of patient and recordings Patient name birthdate and study description are always displayed Tap to display extended data like patie...

Страница 25: ...o move the minimized patient data display around After each recording the minimized display automatically switches to the full display 2 6 2 Change operator and performing physician You can change the operator or performing physician in capture mode by tapping their icon in the lower right corner of the screen Fig 24 Icons for operator and performing physician in capture mode Current operator and ...

Страница 26: ...re a two ways to capture a still image Press the shutter of the camera Tap on the touch screen 2 6 4 Capture videos NOTE Videos can only be recorded when the corresponding license has been purchased If the license has not been purchased you will get a corresponding notice NOTE Recording video requires a lot of space on the camera The length should therefore be limited in the DICOM Camera Server Ob...

Страница 27: ...e or stop the recording Fig 27 Pause continue stop The camera confirms start and stop with click sounds Stop takes you back to still image capture 2 6 4 2 Model DICOM Camera Pro DC DPB Operation via the touch screen is similar to the DICOM Camera Compact DC CC In addition this model has a physical video recording button on the top of the case Fig 28 DICOM Camera Pro DC DPB from above ...

Страница 28: ...les you to stop recording This model has no physical recording button 2 6 4 4 Maximum recording size The maximum file size for a video can be determined in the DICOM Camera Server During the video recording you can see the current recording size in relation to the maximum permitted video size at the top of the screen As soon as 70 of the allowed size is exceeded the color of the display changes an...

Страница 29: ...tion for the current study description the laterality and the comment function must be configured in the DICOM Camera Server for this study description NOTE If the Image gallery option is activated for the camera laterality and comment can also be specified later see section 2 7 4 Each capture of the DICOM camera can be provided with information about the laterality and the image content The entri...

Страница 30: ...laterality and comment in capture mode Tap again to change the setting Select Laterality not specified or Comment not specified or delete your free text comment if you do not want to add laterality or comment to future recordings 2 6 6 Return to worklist Each recording of the DICOM camera can be provided with information about the laterality and the image content The entries affect the following D...

Страница 31: ...shots are automatically deleted as soon as the examination no longer appears in the worklist The recording of an examination marked as unfinished is not deleted by the camera see section 2 7 4 and section 2 7 6 If the option image gallery is deactivated during operation cached recordings are still displayed until the exam has been deleted 2 7 1 Open gallery Fig 34 Capture mode If image gallery is ...

Страница 32: ... to return to capture mode So you can add more images or videos to the gallery Tap or to open the recording in fullscreen mode o Zoom Pinch two fingers not supported by videos o Move Use one finger to move a zoomed still image around o Next or previous capture Swipe left or right to navigate through the gallery in fullscreen mode Tap or to leave fullscreen ...

Страница 33: ...ng the Camera 25 Fig 37 Zoomed image Fig 38 Video player You can also send pictures which have not yet been sent or subsequently taken Already sent captures are indicated by a white check mark on gray background ...

Страница 34: ...y tapping Next to the icon the number of selected captures is shown Fig 40 Icons in the image gallery NOTE If you are attempting to send videos bigger than your administrator has allowed in DICOM Camera Server you ll first guided through the trim process Such video are marked with a ...

Страница 35: ...film you want to keep As long as the video hasn t been sent yet you can change that range any time Open the desired video e g by tapping in the gallery Tap skip this step on video larger than allowed Fig 41 Trim video Define the range you want to keep by moving Tap Trim to complete the process ...

Страница 36: ...ality and comment of a capture in fullscreen mode As long as the capture has not been sent yet you can add or change laterality information or comment In the gallery tap or to open the capture in fullscreen mode In the fullscreen mode tap Select the desired laterality and comment Tap Save NOTE This section describes how to view set or change laterality and comment after capture To set the laterali...

Страница 37: ...t sending captures This study stays permanently in the worklist Tap Delete study to delete the exam including all of its captures Fig 44 Delete study 2 7 6 Appearance of the worklist with enabled image gallery In the worklist you can see at the first glance whether a patient already has captures or not Fig 45 Worklist with enabled image gallery ...

Страница 38: ...res that were sent Patient data is normal 2 8 View and delete captures Viewing captures is supported with enabled image gallery see section 2 7 Otherwise images are deleted right after sending to DICOM Camera Server Sent captures stay for a configured period of time in the cache of DICOM Camera Server see chapter Queue in manual of DICOM Camera Server These cached items can be viewed using the Web...

Страница 39: ...ess font size and battery life Tap in the worklist or to open the menu Fig 46 Menu in worklist Tap Settings The settings are password protected This is to prevent settings from being changed by accident Fig 47 Password to enter settings Tap the line to open the virtual keyboard and enter dca as password Memoranda DICOM Camera Administrator Confirm with OPEN SETTINGS ...

Страница 40: ...ICOM Camera 32 DC EN 220F Fig 48 Settings In some cases a button appears to return to worklist Tap the DICOM Camera icon to get back to worklist Use the hand icon to move the button around Fig 49 Return to worklist ...

Страница 41: ...50 Detected networks left DC CC DC CPB right DC CC2 You will be shown all detected networks If no networks are found there is no reception at your location or the Wi Fi has been disabled Fig 51 Wi Fi disabled and enabled top model DC CC DC CPB bottom model DC CC2 Sometimes hides the button to enable Wi Fi Grab the hand icon and move it to another place You can refresh the list of Wi Fi networks ma...

Страница 42: ...el DC CC2 Hidden networks must be added manually Fig 54 Scroll to the bottom to add a new network model DC CC und DC CPB Fig 55 Add network model DC CC2 Tap long on an existing network to modify it 3 1 1 Configure SSID and security Create new network or modify existing one Enter SSID ...

Страница 43: ...n help you with that Tap Security Fig 57 Enter type of protection and password 3 1 2 Configure static IP address As per default the camera uses DHCP to retrieve its IP address However you can enter a static IP address as well Activate check mark Advanced options Select for IP settings Static ...

Страница 44: ...DICOM Camera 36 DC EN 220F Fig 58 Enter static IP address Tap on a line to modify the content In some cases the virtual keyboard opens in fullscreen mode Fig 59 Modify data Tap or Next to go to the next input field ...

Страница 45: ...era must know his IP address Open Settings screen see chapter 3 Settings Tap DICOM Camera Server Fig 60 Configure DICOM Camera Server s IP address Tap the line of the text input field The virtual keyboard opens in some cases in fullscreen mode Confirm with or Finish Fig 61 Enter IP address ...

Страница 46: ...rned on also from standby Specifying a screen lock method is part of the certificate installation if not specified yet Fig 62 Screen lock method swipe pattern NOTE If you want to change or remove the lock method contact the MESO service The certificate files must exist in the root directory on a microSD card Fig 63 microSD card Insert the prepared microSD card Open the settings see chapter 3 Setti...

Страница 47: ...ttings 39 Fig 64 Select certificate Fig 65 No valid certificate on microSD card Name the certificate to be installed Fig 66 Name certificate If no screen lock method is set yet you are guided to specify one ...

Страница 48: ...for 1 to 4 hours of inactivity Fast Start up only DC CC2 do not enable on DC CC and DC CPB The camera remains in a sleep mode for 24 hours after power off Turning on the camera is much faster in this mode You save about 10 of battery life compared to regular standby Change the settings as follows Open settings see chapter 3 Settings Tap Power Select the desired setting in the list Fig 67 Power set...

Страница 49: ... model DC CC2 Starting the camera must be disabled 3 5 Display Some display settings can be configured on the camera Open settings see chapter 3 Settings Tap DISPLAY Tap on the desired option e g Brightness Fig 69 Brightness settings on DC CC and DC DPB NOTE Model DC CC has no setting Automatic brightness ...

Страница 50: ...NTION High brightness level shortens battery life 3 5 1 Sleep Standby Specify the time of inactivity when the camera is put into standby see also chapter 2 1 Power on off and standby Open settings see chapter 3 Settings Tap DISPLAY DC CC and DC CPB Tap Screen timeout DC CC2 Tap Sleep ...

Страница 51: ...Webviewer is a pure viewer and not intended to change or delete captures 4 1 1 Open Webviewer Enter the address of the Webviewer in the address bar of your browser The address always starts with http followed by the name or IP address of the machine the DICOM Camera Server is running on Consult your administrator for further assistance The log in page is shown after browsing to the Webviewers addr...

Страница 52: ...lar form Click on a line to view the recordings Fig 72 Studies search 4 1 3 View images The preview shows all images of the study Fig 73 Captures of a study Click a photo to open it in fullscreen A slide show appears allowing you to easily navigate through all images of the study ...

Страница 53: ...4 Webviewer 45 Fig 74 Image in fullscreen mode 4 1 4 Change Webviewer password After successful login you can change your password using Settings Fig 75 Webviewer settings ...

Страница 54: ...ghtening Battery is charging 5 1 2 Battery tips The display shortens battery life the most Put the camera in standby when it s not needed see chapter 2 1 Battery health is kept best when the battery level is always between 30 and 90 Avoid deep discharge of the battery If you do not use the camera for an extended period of time turn it off completely see chapter 2 1 5 2 Cleaning Turn camera off bef...

Страница 55: ...expense of the material due to unavoidable chemical interactions Improper cleaning and penetration of fluids into the interior of the device can lead to damage and impair the safety of the user 5 3 Storage Keep the camera in a dry and protected area IMPORTANT If the camera still contains patient data and captures the rules for the privacy of your institution apply to the camera ...

Страница 56: ...installed Confirm the update by clicking INSTALL just once It s not necessary to tap NEW or ALL In some cases several software modules receive an update Therefore the update screen is shown several times Confirm each update by tapping INSTALL once Software update You cannot resume your work until you have completed the update It takes only a few seconds You will then receive information about the ...

Страница 57: ...information Tap or and then Info in worklist or operator selection to open the device information screen Sometimes the support team asks you about specific readings on that screen Menu to open device information screen Device information ...

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