ConMed CMS9000 User Manual Aug 2018

INTRODUCTION

NOTES/WARNINGS Warning: Disconnect power supply before servicing. The CMS9000 and its internal components meet the requirements for applicable ETL, FCC, CE, CB, CIB and other required certifications. B ac k u p vide os a n d images to ex te r nal s to rage periodically; this system is not a long term storage or archiving device. Warning: Restoring a backup will erase any settings and surgical cases that are presently stored on the machine that is receiving the restore. Backup surgical cases prior to a restore to prevent loss. Prior to sending the CMS9000 in for service; please backup video and still images to external storage. Med X Change, Inc. and ConMed corporation are not liable for data loss on the CMS9000. Med X Change, Inc. strongly recommends the client copy all videos immediately to a USB drive or use the archiving feature in accordance to the User Manual. Med X Change, Inc. strongly recommends you purchase and hook up a battery back up system as well as a surge protector (ex. 1100 VA surge protector), in accordance to the User Manual. Med X Change, Inc. will not be held responsible for any personal/internet use. The system is to be used for Digital Recording only. The warranty will be null and void, in response to any repairs that may be needed, if personal/internet use is apparent. Warning: In case of an Emergency, Do not position device in way that makes it difficult to disconnect the device’s power mains.

Warning: Do not touch the CMS 9 0 0 0 and patient simultaneously. The CMS9000 is not to be used within 1½ meters of patient’s chair or table in the patient environment. Connection to other equipment could result in previously unidentified risks to patients, operators or third parties. The responsible organization should identify, analyze, evaluate and control these risks. Changes to the network (such as changes in the network configuration, connection/disconnecting of items to the network, update/upgrade of equipment connected to the network) can introduce new risks that require additional analysis. Keep combustible materials away from System while in use. The plastic material used for the front of the CMS9000 PC enclosure has a UL94 flammability classification of 94H-2. A warm damp cloth can be used to wipe the outside of the unit. Warning: Do not connect items that have not been specified as part of the System or specified as being compatible with the CMS9000. Warning: GPIO and Remote connections must be IEC60950 approved. Warning: There are no known electromagnetic or other interference between the system and other devices. If the system does cause harmful interference, the user is encouraged to correct the interference by one of the following methods: 1.

Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

2. 3.

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Relocate the system or the device that is receiving the interference. Increase the separation between the system and the device that is receiving the interference. Connect the system to an outlet on a circuit different from that to which the device is connected.

INTRODUCTION (CONTINUED)

There are preventative measures that can be taken to ensure proper functionality of the system. The system should be shut down and restarted periodically (at least every other day). A proper shutdown sequence would be to press the power button on the front of the system one time and release. Holding the power button down until power is off should only be done when directed by Med X Change Technical Support. Warning: No modification of this equipment is allowed. Failure to comply could result in electric shock or death. T h e re are n o re p air ab l e c o m p o n e nt p ar ts in t h e CMS9000. Any system that needs repair should be returned to the manufacturer for such repair. This equipment is not suitable for use in the presence of flammable anesthetic mixture or with nitrous oxide. Med X Change, Inc. cannot be held responsible for any data loss in accordance to the System. *Note for California: Perchlorate Material - special handling may apply, See: www.dtsc.ca.gov/hazadouswaste/perchlorate

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INTRODUCTION (CONTINUED)

ABOUT THE CMS9000

FEATURES

The CMS9000 is a complete medical recording and documentation system that can capture High Definition video and images from multiple sources and store the captured media with patient information. It can duplicate captured videos and images to portable media, network storage, iOS and Android devices, and PACS (Picture Archiving and Communication Systems) for documentation, storage, and presentation.

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The software is built upon H.264 technology; utilizing the best compression and the highest quality video capture available. Videos are stored as H.264 .MP4 files. Images are stored as JPEG, BMP, or PNG files. To keep pace with the rapid advancements in medical and media technology, the software is easily updateable as new features and advancements become available. The system has no patent applied parts and has not been investigated for patent connection.

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1080p simultaneous display and capture from 2 independent video sources iOS/Android wireless application for live still images, Surgical Repor ts, media review and copying HD video (via USB) Full touch screen monitor compatibility DICOM Modality and Local Patient Work List DICOM Storage and network case archive SuperSpeed USB 3.0 (up to 5gbps) connections for fast file transfers Integrated 802.11ac WiFi

CONTENTS

CONTENTS Upon receiving the CMS9000, the following contents should be in the box: •

1 - CMS9000 Video Recording System

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1 - 6’ Ethernet cable

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1 - User Manual download card

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1 - DisplayPort to DVI video adapter

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1 - 10’ Medical Grade power cable

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1 - 6’ DVI-D Single Link cable

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1 - USB Keyboard with built-in touch pad

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2 - 6’ 3.5mm remote cable

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1 - 6’ USB 3.0 A to B cable

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1 - 12’ GPIO cable

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1 - 6’ DVI to HDMI cable

CMS9000 FRONT

Hard Drive Activity Light Power Activity Light Power Button

CMS9000 BACK USB 2.0

Secondary Output (optional)

USB 3.0

Primary Input Secondary Input

USB 3.0 Main Display Microphone Input Main Audio Output

Potential Equalization Terminal AC Source

Capture: 3.5mm/2.5mm Record: 3.5mm/2.5mm Remote: Record/Capture General Purpose Input/Output

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WORK LIST

WORK LIST PAGE

WORK LIST PAGE CONTROLS

The Work List Page is the starting point (by default) to which a user will go to begin a surgical case. The user may enter Patient Information to create and begin a case, schedule future cases, organize the Work List using various filter buttons, or receive and display pending cases from a Work List server.

Clear Filters Button – removes all filters that have been applied to the Work List on the Work List Page.

Work List Modes can be chosen on the Setup Page > Work List Tab (Work List Tab). A user may choose to enter no Patient Information and begin a case, or to enter as much Patient Information as desired.

Delete From Work List Button – delete the case that is presently selected in the local Work List.

Local Work List (Default) – All cases are created and maintained on the system locally. There is no required Patient Information to create and begin or to schedule a future case. DICOM Modality Work List (MWL) – The remote Work List server delivers cases to the system, allowing users to add multiple cases to the local Work List or start a case right away. Unscheduled cases can also be created and completed locally. None – Navigation to the Work List Page is not available and the software displays the Record Page upon launch. Required Fields – Patient Data Fields can optionally be set as Required (Patient Fields Tab) and will appear in red in the Patient Information section indicating that this field must have an entry before a case can begin.

Today’s Work List Button (default) – displays only cases on the Work List that are scheduled by the Case Date for the present day.

Search Work List Button – search for scheduled patients to be added to the local Work List from the configured DICOM Modality Work List. Cases may also be started from the Search Work List screen. Start Case Button – begins the case that is presently entered into the Patient Information or selected in the Work List. Save Button – saves the case that is presently entered into the Patient Information to the Local Work List. New Button – clears all information entered into the Patient Information, restores all preset default values to the Patient Information. Filter Box – enter text and numbers to filter the Work List by a keyword. Patient Field Button – sorts the Work List by the filter text entered. Deactivate Filter Button – removes the filter from the Work List. Scroll Bars – adjusts the view of the Patient Information Fields to enable the user to see all of the cases and data in the Work List and in the Patient Information sections of the Work List Page. Scroll Bar Arrow Buttons – move the Scroll Bars in small increments. On Screen Keyboard (OSK) – enters Patient Information.

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WORK LIST (CONTINUED)

Patient Information Text Boxes – create a collection of patient demographics that are associated with a case to be created. Archiving Indicator – displays the present status of media to be automatically copied to external storage (only visible when Application Status Bar is enabled in Setup Page > General > System Tab).

Note: The list of procedures in the drop-down can be narrowed down by typing the characters contained in the Procedure Description.

FIGURE 1-1

Printing Indicator – displays when a print job is being sent to the printer (only visible when Application Status Bar is enabled in Setup Page > General > System Tab). On Screen Keyboard Button – displays the on screen keyboard when clicked.

PATIENT INFORMATION

FIGURE 1-2

Patient demographic infor mation is entered here to create a case (Figure 1-1). Patient Fields may be re-sorted, set as required to start a case, or disabled and hidden depending on user preference and the present Work List Mode (Patient Fields Tab). For consistency, certain Patient Information Fields can optionally be set as ‘Required’ to begin and store a case. Required Fields will be highlighted in red and users will not be able to star t the case until all required fields are populated (Figure 1-2). The Per forming Physician f ield can be populated with freehand text and contains a drop-down menu in which performing physicians will be stored. This field is automatically populated with the username of the user who is logged in unless a default value is configured in the Patient Fields Setup (Patient Fields Setup). Performing Physicians are added to the dropdown menu when a surgical case is added to the local work list or started. When surgical cases originate on a Modality Work list, the performing physician is added to the list when the case is started. Stored physicians will be listed in alphabetical order. This list will be narrowed down when typed characters match physicians in the list. Unwanted physicians can be removed from the list by using the ‘X’ next to the name.

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WORK LIST (CONTINUED)

CREATING A CASE ON THE WORK LIST PAGE The user may create a case on the Work List Page at any time. A scheduled or unscheduled case may be created and begun in any of the Work List modes. To create a case: 1. Click the ‘New’ Button on the upper left side of the page (Figure 2-1). 2. Enter data into the appropriate Patient Information Fields. Pressing the ‘Enter ’ key on the keyboard m o v e s t h e c u r s o r d o w n to t h e n e x t P a t i e n t Information Field (Figure 2-2). 3. After entering all desired patient information, click the ‘Start Case’ Button on the upper left side of the page to begin the case or optionally in Work List mode; click the ‘Save’ Button to add the case to the Work List for future use (Figure 2-2). 4. When the case is star ted, the Record Page will display and the System will be ready to capture videos and images for the case created (Figure 2-3). Note: There is no limit to how many cases can be created and saved to the local Work List; this allows cases to be created and scheduled in advance. The software populates the Case Date field with the present date and time each time a new patient entry is started. The Case Date can be edited and changed to a future date if desired. If the Case Date or time are incorrect, they can be adjusted on the Setup Page > General Tab > Regional Sub Tab > Date/Time text box (Regional Sub Tab).

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FIGURE 2-1

FIGURE 2-2

FIGURE 2-3

WORK LIST (CONTINUED)

STARTING A CASE FROM THE WORK LIST PAGE

DELETING A CASE FROM THE WORK LIST PAGE

Selecting and starting a case from the Work List Page is the same process in each of the Work List Modes (Figure 3).

The user has the ability to delete scheduled cases from the Work List in the event of a cancelation. Deleting a case from the Work List Page only removes it from the local system. MWL cases which have been removed from the local Work List will still exist on the server (Figure 4).

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Browse the cases listed in the middle of the Work List Page and click on the desired case to select. The case will highlight to show that it has been selected. The Patient Information section will populate with the information from the selected case. Click the ‘Start Case’ Button to begin the case.

When a case is selected and started, the case will be removed from the Local Work List Page. After a case has been started and/or completed, it will appear on the Review Page. From the Review Page, the user has the ability to review, copy, and print media. If the user wishes to alter the Patient Information or add media to a case that was previously created with the software, the Review Page offers this function (Review Page). Patient Information in cases that were started from MWL may be edited but it is not recommended.

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Browse the cases listed in the middle of the Work List Page and click on the desired case to select. The case will highlight to show that it has been selected. The Patient Information section will populate with the information from the selected case. Click the ‘Delete From Work List’ Button to delete the selected case from the local Work List.

FIGURE 4

FIGURE 3

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WORK LIST (CONTINUED)

FILTER WORK LIST The Work List Page provides the user the ability to sort the cases in the Work List by any native Patient Information Field, by date range, and by cases scheduled for the present date (default). After applying filters, click the Today’s Work List Button to revert back to viewing only the cases scheduled for the present date or click the Clear Filters button to remove all filters (Figure 5).

FIGURE 5

ADDING CASES FROM A DICOM MODALITY WORK LIST In MWL mode, the ‘Search Work List’ button allows cases to be added to the local Work List or begin cases right away. Users can filter the modality Work List search criteria using Patient ID, Case Date, and Modality at the network level. Search results can be further filtered locally by any native patient field (Figure 6-1). Additionally, administrators may apply an AE Title filter on the Work List Setup page to only search for the cases assigned to the desired AE Title (Figure 6-2). To add patients to the Local Work List, place a check into the box to the left of the desired patient(s), then click the ‘Add To Work List’ Button. A case may be started right away if only 1 patient is checked and the user presses Start Case. Press the ‘Exit’ button to leave the Search Work List screen.

FIGURE 6-1

FIGURE 6-2

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RECORD

CREATING A CASE ON THE RECORD PAGE If desired, the Work List page can be disabled and Record Page can be the first page by choosing ‘None’ under the Work List Setting on the Setup Page. Users may begin a case on the Record Page at any time. Patient Information can be entered prior to the start of a case or at any time before the case is closed. To create a case with Patient Information: 1. Click the ‘New Case’ Button on the lower left side of the page and the Edit window will appear (Figure 7-1). 2. Enter data into the appropriate Patient Information Fields. Pressing the ‘Enter ’ key on the keyboard m o v e s t h e c u r s e r d o w n to t h e n e x t P a t i e n t Information Field (Figure 7-1). 3. After entering all desired patient information, click the ‘Save’ Button on the lower left side of the Edit Window to begin the case (Figure 7-1). 4. Use the Information Tab ‘Edit’ Button to add or edit Patient Information any time while a case is in progress (Figure 7-2). 5. Clicking the ‘Close Case’ button will save all entered data on the Review Page (Figure 7-2).

FIGURE 7-1

FIGURE 7-2

The system populates the Case Date field with the present date and time each time a new patient entry is started. The Case Date can be changed to a future date if desired. If the Case Date or time are incorrect, they can be adjusted on the Setup Page > General Tab > Regional Sub Tab > Date/Time Text Box (Regional Sub Tab). To begin a case without Patient Information: 1. Use touchscreen controls, Endoscope triggers or foot pedal commands to capture media. 2. Use the Information Tab ‘Edit’ Button to add or edit Patient Information any time while a case is in progress (Figure 7-2). 3. Clicking the ‘Close Case’ button will save all entered data on the Review Page (Figure 7-2).

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RECORD (CONTINUED)

RECORD PAGE CONTROLS Status Tab – displays the current segment time and overall recording time of each video capture source while video capture is in progress, the storage space that has been filled, and the total number of video segments that have been captured in the present surgical case. Recorded videos less than 3 seconds long are not saved. Archiving Tab – displays status of media items to be sent to the Archiving Location(s) set on the Setup Page > My Settings Tab > Media Sub Tab (Media Sub Tab). Archive status indicators and their meanings:

Archive Pending Archive in Progress

Archive Failed

Record/Pause Button – initiates and ends a video segment. A red dot appears to indicate video capture is in progress.

CAPTURING VIDEO The Record Page captures HD video from the Primary Camera and optionally from the Primary and Secondary Cameras simultaneously (Figure 8). Videos are limited to 5 minute Segment Length by default.

FIGURE 8

Archive Succeeded

Images Tab – view thumbnails of previously captured images and their timestamps without having to leave the Record Page. Information Tab – displays the Patient Information for the case in progress. Click the ‘Edit’ Button to alter the Patient Information for the case in progress. Annotation Button – used to assign an annotation to the last still image captured. The user may type, select from a list, or use an attached microphone to input an annotation from the list. When selecting annotations from the list, users can search the list to find annotations faster. Delete Button – delete the captured image shown on the upper right of the Record Page. Users must provide confirmation to delete the image. New/Close Case Button – signal the start (Work List set to NONE) and completion of a surgical case and concludes of all automated background functions like automatic printing (Printing Sub Tab), and automatic send to DICOM (DICOM Storage Tab). Capture Button – capture a still image from the Primary Camera. A counter displays the total number of still images captured in the current case. If Multi Capture is enabled, a still image from all connected sources will be captured (Media Sub Tab).

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CAPTURING STILL IMAGES The Record Page captures still images from the Primary Camera (Figure 9). Images are captured in JPEG format by default, and can optionally be changed to capture BMP or PNG image files (Media Sub Tab).

FIGURE 9

REVIEW

REVIEW PAGE

REVIEW PAGE CONTROLS

A user is able to use the Review Page to review and expedite media workflow for cases that have been captured on the Record Page. Recorded cases can be viewed, annotated, deleted, copied to external media or network folders, burned to optical disc using an external disc burner (not included), printed, and sent to a DICOM Storage server while a surgical case is in progress or after a surgical case is completed. Users may only review cases captured with the current logged-in user, Administrators can view cases captured by all users.

List View Controls: Clear Filters Button – removes all filters that have been applied to the case list on the Review Page.

The Review Page has two views that will display based upon the presence of an open surgical case or no surgical case in progress. When a case is open, the Review Page will only show media for the case in progress. When a case is not in progress, the Review Page will default to List View and display all of the user’s cases stored on the system.

REVIEW PAGE VIEWS List View – displays all of the closed surgical cases for the user. To select a case, click the Checkbox on the left side of the page next to the desired case. Case View – displays a list of Thumbnails for each still image and video captured. To select an image or video click in the middle of the Thumbnail and a check icon will appear over the Thumbnail. Playback View – displays a large screen view of the media item. To select an image or video click the Media Item Checkbox on the upper right of the page.

Filter Box – enter text and numbers to filter the Work List by a keyword. Activate Filter Button – sorts the Work List by the filter text entered. Deactivate Filter Button – removes the filter from the case list sorting. Scroll Bars – adjusts the view of the Patient Information Fields to enable the user to see all of the cases and data in the case list. Scroll Bar Arrow Buttons – move the Scroll Bars in small increments. Sessions – displays the start time, stop time and length of the corresponding case session. The sessions screen also allows for review and printing of the case checklist. Appending to a closed case creates additional sessions. Top Checkbox – selects and deselects all cases. Checkbox – selects and deselects the individual case or multiple cases to copy, burn, or delete. View Button – changes the page to Case View and for the corresponding surgical case. Edit Button – opens pop-up window that allows the user to edit Patient Information of the corresponding surgical case. A p p e n d B u t t o n – all ows t h e us e r to re o p e n t h e corresponding surgical case to add additional media. When clicked, a warning dialog pop- up window will appear to confirm that the user wishes to navigate to the Record Page with the corresponding surgical case loaded to append media to the case. If Case checklist is enabled, the user will be required to complete the checklist before appending to the case.

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REVIEW (CONTINUED)

Copy Button – navigates to the Copy Page to duplicate case media to external media or network folders or MedXStream app (iOS connected by sync cable).

Select all Images – selects only images in the case for copy, print, burn or delete. Print Button – print still images or save images to a PDF.

Delete Button – allows a user to delete a selected case. A warning dialog pop-up window will appear to confirm that the user wishes to delete. DICOM Button – initiates a transfer of the selected cases to the configured DICOM Storage server when clicked. This button is only visible when DICOM storage is enabled on the Setup Page > DICOM Storage Tab (DICOM Storage Tab). Case View Controls: Back Button – navigates to List View. This button is not available when a surgical case is in progress. Thumbnails – small images that represent videos and still captures for the selected surgical case. Click in the center of the Thumbnail to select the media item for print, copy, burn, or delete. Annotate Button – allows a user to add an annotation to still images. Playback View Button – navigates to Playback View and displays the media item. Videos will begin playback immediately. Delete Item Button – allows a user to delete the media item. A warning dialog pop-up window will appear to confirm that the user wishes to delete. Select All Button – selects all case media for copy, burn, or delete. Select Annotated Button – selects all annotated case media for copy, burn, or delete. Select None Button – deselects all selected media items. Select All Videos – selects only video segments in the case for copy burn or delete.

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Copy Button – navigates to the Copy Page to duplicate case media to external media or network folders. Delete Button – allows a user to delete a selected case. A warning dialog pop-up window will appear to confirm that the user wishes to delete. DICOM Button – initiates a transfer of the selected cases to the configured DICOM Storage server when clicked. The DICOM icon will be displayed on any image thumbnail which has received a successful storage status from the DICOM services. Playback View Controls: Back Button – navigates to Case View. Media Item Checkbox – selects the displayed media item for copy, burn, or delete when the user navigates back to Case View. Annotate Button – allows a user to add an annotation to the media item. Delete Button – allows a user to delete the displayed media item. A warning dialog pop-up window will appear to confirm that the user wishes to delete. Case View Button – navigates to Case View. Controls specific to video playback: Mute Button – activates and deactivates audio playback of the video displayed. Speaker Button – allows a user to mute or unmute playback of the video. Volume Slider – adjusts volume of the audio playback of the video displayed. Play/Pause Button – starts and pauses playback of the video displayed.

REVIEW (CONTINUED)

PRINT PAGE .25x Button – slows video playback to 25% of full speed. .50x Button – slows video playback to 50% of full speed. Normal Button – returns video playback to full speed. Capture Button – captures a still image from the video displayed. Loop Button – when activated the selected video repeats playback until stopped. Looped playback is activated by default. Seek Bar – click and drag the dot on the Seek Bar to navigate to a desired place in the video displayed.

FILTER BY PATIENT FIELD CRITERIA

The Print Page is accessed from the Review Page and offers full featured printing options (Figure 11). The user can send the print job to an available printer in the list or create a PDF file to print later, select a page layout, crop HD images to a 4:3 ratio to save black ink with scope images, add a personalized heading and logo to the top of the printed page, make adjustments to the images prior to printing, and include dates, annotations, and add up to 6 Patient Fields to the printed page. Any adjustments made to the print layout on the Print Page will not be saved after the page is closed, it is recommended that the user set the preferred default print settings on the Setup Page > My Settings Tab > Printing Sub Tab (Printing Sub Tab) during the initial setup.

FIGURE 11

When in List View, the Review Page can be filtered in the same manner as the filters on the Work List Page (Work List Page) and persist over reboots of the system (Figure 10).

FIGURE 10

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REVIEW (CONTINUED)

PRINT PAGE CONTROLS Print Preview Navigation Buttons – used to display each page of a multiple page print job. Print Preview Window – displays the print job with all of the set options as it will look when printed. Selected Printer – used to select an installed printer to send the present print job. Page Layout Dropdown – used to select 1, 2, 4, 6, 8, or 15 images per printed page. 4:3 Crop Checkbox – activate this checkbox to crop a 16:9 image to a 4:3 image. This is useful with scope images.

Enhancements Dropdown – used to access digital Gamma, Brightness, Saturation, Sharpen, and Contrast adjustments for the images in the present print job. Enhancements Checkboxes – when activated the Enhancement Sliders will become available and a print job will include adjustments to image color, brightness, contrast, and sharpen adjustments. This does not alter the original image. Enhancement Sliders – used to adjust the selected Enhancement. The result of the adjustment will be seen in the Print Preview Window as it is made. Copies – adjusts the number of copies for the present print job.

Include Annotations Checkbox – when activated the print job will include assigned annotations under each image.

Print Button – sends the print job to the specified printer with all of the preset printing options.

Header Text Box – add text here to add a header or a title for all of the pages in the present print job.

Save as PDF Button – saves the print job to a PDF file all of the preset printing options.

Logo Checkbox – when activated the print job will include a preselected logo at the top of the pages.

Exit Button – closes the Print Page without sending the present print job.

Logo Dropdown – used to select a custom logo JPEG file. This file will be saved into the software and able to be reused at any time. Footer Fields Dropdown – used to select Patient Fields to be added to the present print job. Footer 1-6 – used to set the specified Patient Field to respective position of the numbered footer. Include Image Date Checkbox – when activated the print job will include the date of image capture under the images. E n h a n c e m e n t s E n a b l e d – w h e n a c t i v a te d , t h e Enhancements Dropdown will become available. It is recommended to configure color correction settings in the printer before using these enhancements.

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REVIEW (CONTINUED)

COPY PAGE

LOCATION PAGE

The Copy Page is accessed from the Review Page and is used to copy surgical cases to external devices and network folders. The Copy Page displays the file size of the media to be transferred and the percentage of completion of the present copy job. To copy a case to an external device or network folder, select the desired media then click the ‘Copy’ Button on the Review Page to display the Copy Page (Figure 12).

This feature is accessed from the Copy Page when the ‘Copy Location’ Button is clicked and is used to select a location to copy surgical cases (Figure 13).

FIGURE 13

FIGURE 12

LOCATION PAGE CONTROLS An arrow will appear to the left of the dropdown when a copy location becomes available. Click the folder name to select the Copy Location.

COPY PAGE CONTROLS Include Patient Data Checkbox – when activated, Patient Information will be included in a patient text file contained in a secure zip file which uses encryption to prevent unauthorized viewing of PHI. Viewing the patient data text file requires the login password of the user which created the file to be entered. If deactivated the case will be stored without patient information. If required, the secure zip can be eliminated and the text file will be copied unencrypted. See Setup > General > System Allow Export of unencrypted PI. Copy Location Button – choose a location to copy selected items. The copy location defaults to the first available USB device. Media items can be copied to external USB drives, shared network folders and iOS devices with the MedXStream app installed. Eject Button – used to safely eject a removable USB device after a copy job has completed.

Removable Drive Dropdown – Copy to external USB drives. MedXStream (iOS) Dropdown – copy to the MedXStream app on iOS devices connected via USB cable. Remote Dropdown – copy to a network share using SMB v3.0 protocol. Authentication with network location must be specified using the ‘Connect to UNC Button’ first. SMB v3.0 allows the connection between the recorder and network share to be encrypted. The network share governs whether it is encrypted or not. C o n n e c t to U N C B u t to n – enter a net wor k path , username and password to access a shared network location. Leave the username and password blank if they are not required. After a UNC path is entered, it must be selected on the Remote Dropdown to be the chosen Archive Path.

Abort – used to cancel a copy job in progress. Any items already copied will not be removed. Exit – closes the Copy Page.

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SETUP

SETUP PAGE

SYSTEM SUB TAB

The Setup Page is divided into Tabs on the left side of the page and Sub Tabs near the top of the page. Each Tab and Sub Tab contains a number of controls that relate to its title. The Setup Page allows for configuration of system wide settings and individualized settings for the user.

(Figure 15) Version Numbers – displays the sof tware GUI and Firmware version numbers. Please have this information available when troubleshooting with Med X Change support.

Admins can configure system wide security settings, manage usernames and passwords, camera settings network settings, Work List modes, configure Work List and DICOM server settings, manage patient fields, checklist questions, manage the trash bin and user activity for all users, procedures and annotations lists as well as their own personalized annotation, patient field, procedure, media, and printing preferences and view the user manual. The Setup page also allows logged in users without admin privileges to manage their own trash bin, customize settings such as enabling or disabling procedures, annotations and patient fields as well as setting printing and media preferences. A non-admin user may also view software version information, network settings, the user manual and their own user activity.

GENERAL TAB The General Tab contains Sub Tabs for System, Camera, Network, Regional settings. The General Tab is displayed by first when the user navigates to the Setup Page (Figure 14).

FIGURE 14

MedXStream Display Name – allows users to choose a custom display name for the CMS9000 which is useful when scanning for recorders in the MedXStream mobile app. The recorders serial number is used by default. If the Display name is erased and saved, it will revert back to the serial number or hostname configured in Windows. Reset System Settings Button – resets system settings to factory default. This button does not erase Work List entries, cases, regional or security/user management Settings. Software Update Button – used in conjunction with a USB flash drive to update the software. Instructions for update will be provided by Med X Change, Inc.. Delete Cases – move cases for all users to the trash bin. Choose all cases or cases older than 7, 14, 30, 60, 90 or 120 days. Work List items are considered cases and will be moved to the trash bin with this feature. Auto Delete Cases – set the system to automatically delete cases older than 7, 14, 30, 60, 90, or 120 days starting when the control is set and continuing until the control is deactivated. Auto delete will remove cases and media items from the system permanently, bypassing the trash bin. Purge Local Work list – removes all cases in the local work list without removing completed cases. Delete Storage History – deletes the DICOM store status of all media items stored on the system. This control can be used when a case has been successfully sent to DICOM storage and the user wishes to send the case a second time or to other servers. Mute System Audio Checkbox – deactivates the audible feedback when a still image is captured and when a video is started or stopped.

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SETUP (CONTINUED)

Enable OSK Checkbox – enable or disable the automatic popup of the On Screen Keyboard. This control is enabled by default. With this setting disabled, users may still activate the On Screen Keyboard with the icon on the application status bar. Popup on screen keyboards contain an ‘X’ to dismiss the keyboard and a keyboard language selector to quickly change languages if necessary. Enable Application Status Bar – (disabled by default) displays or hides the top bar on the software window that displays the time and date, Printing Indicator, Archiving Indicator OSK button and window management buttons. Disable USB Mass Storage – prevent the use of USB storage devices. This option is only available to software admin users and must be logged into Windows with administrative privileges. Non admin users will be able to see the status of this feature, but will not be able to alter it. Session Timeout – enabled and set to 30 minutes by default. Blurs out the user interface when the specified period of inactivity is reached to prevent unauthorized viewing of ePHI. The password for the user currently logged in is required unlock the user interface after a session timeout. Capturing still images and video recording by an attached foot pedal or endoscopic camera head is possible during a session timeout. The video preview is viewable during a session timeout. Allow Export of Unencrypted PI – (disabled by default) In order to protect Patient Health Information, case storage folders copied to USB are named using a date and timestamp out of box. With this feature, software administrators can choose to allow Patient Name or Patient ID within the case storage folder name. This control also allow the patient.t x t file to be stored unencrypted.

FIGURE 15

CAMERA SUB TAB The Camera Sub Tab contains controls for the camera inputs. Inputs may be disabled, renamed, or set as the default (Figure 16). Video Input Source Label Text Boxes – add a custom label to each Video Input Source Button on the Record Page. There is a 9 character limit for the custom label. Video Input Source Enabled Checkboxes – enables or disables the corresponding Video Input Source Button on the Record Page. PIP Location Radio Buttons – selects the location of the PIP window on the Record Page video preview. Primary and Secondary Camera dropdowns – chooses the priority of the video inputs. The primary channel is also the default input when the software opens. The secondary channel is the optional camera source when displaying PIP, Side by Side.

FIGURE 16

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NETWORK SUB TAB The Network Sub Tab contains settings that allow the user to view and admins to adjust Internet Protocol version 4 (IP v4) set tings (F igure 17 ). IP v 6 is not supported. Each networking adapter in the system has its own sub tab. Admins must be logged into Windows with administrative privileges to change these settings.

Key – configure the passcode to join the wireless hotspot. The passcode should be between 8 and 63 characters. Enable Checkbox – enable or disable the hotspot feature.

FIGURE 17 DHCP/Manual Dropdown – Select DHCP to allow the facility’s network infrastructure to assign network values to the system automatically. Select Manual to specify network values that do not change. IP Address – displays the present IP address. Subnet – displays the present IP subnet mask. Gateway – displays the present default gateway. DNS’s – displays the present DNS. Refresh – view the current status of the selected connection. Connect to WiFi – Connect to an existing infrastructure based WiFi network. HotSpot status – Indicates whether the wireless hotspot feature is enabled or disabled. Configure HotSpot Button – allows admins to set up a dedicated WPA2 secure hotspot for CMS9000. Use this feature in conjunction with the MedXStream mobile app or live streaming for a dedicated wireless network. The hotspot feature can be used at the same time as wired network, but not when connecting to a facility’s wireless network. Configure HotSpot Page: SSID – configure the name of the dedicated wireless hotspot. There is a 32 character limit for the SSID.

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