EvolutionHD U501-01 User Manual Ver 3.4 May 2015

TABLE OF CONTENTS (CONTINUED)

Case storage folder name 54 Still preview layout 55 Image file type 55 Bitrate 56 Advanced Media Settings 56 File type 57 Video input 57 DVI Color Shift 58 Mute mic 58 Mute system audio 59 Encryption password 59 Segment length 60 Force patient info 60 Media Save 61 Procedures61 To Add a Procedure 61 To Edit an Existing Procedure 62 To Delete an Existing Procedure 62 Patient Fields 63 To change the available Patient Fields 63 Security63 To enable Security 63 To disable Security 64 To Add users 64 To Edit a user 64 To Delete a user 65 System65 To Update the Software 65 To Reset system settings 66 To Purge Data 66 To Auto Delete Cases 67 To Delete Cases 67 Enable Elo Touchscreen Support 68 Touchscreen Calibration 68 Software Versions 69 USB Drive Formatting 69

LOCATION SELECTOR

USB Location Selector Network Location Selector MedXStream (iOS) Location Selector

SAFETY / ELECTRICAL / MAINTENANCE

79

SYSTEM COMPLIANCE STATEMENTS

81

MED X CHANGE CONTACT INFORMATION

85

EvolutionHD™ Computer 79 Connecting Computer to Power 79 Classifications79 Notes80 Warranty80 System Compliance Statements & Tables

70 70 71 72

DICOM73 Enable Worklist Enable Storage Server Diagnose DICOM Automatically Upload Upload Videos

73 74 75 75 76

SOFTWARE RECOVERY

77

Software Recovery

77

TECHNICAL78 EvolutionHD™ Product Specifications Glossary of International Symbols

78 78

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INTRODUCTION

ABOUT THE EVOLUTION HD™ SYSTEM

The Med X Change EvolutionHD™ System is a digital recording device (documentation system) that can record Standard Definition (SD) & High Definition (HD) video from multiple sources, take digital stills without interrupting video capture, and can duplicate the captured data to portable media for storage, documentation, and presentation. The EvolutionHD™ video capture software is built on H.264 technology, utilizing the best compression and highest quality video capture available. Videos can be stored as HD H.264 .mp4, or .mov files Because of rapid advancements in technology, the system’s software is easily upgradeable via USB Flash Drive, providing you with updates that will keep your system “State of the Art”. This is a dynamic system that can grow and be adapted as technologies change.

VIDEO AND STILL IMAGE FORMATS AND QUALITY

Video: The Med X Change EvolutionHD™ System utilizes the latest in H.264 encoding and compression. Videos are stored as AVCHD H.264 .mp4, or .mov files Main @ L4.1. H.264 encoded.mp4/.mov files are OSX and Windows compatible. Still Images: Still images can be stored as uncompressed bitmap files (.bmp), compressed JPG and PNG files, and .dcm (DICOM) files. All formats are OSX and Windows compatible formats. HD still images are captured in 1280 x 720p, or 1920 x 1080p format. The SD still images are captured as 640 x 480 (~ 1/3 of a mega pixel).

STORAGE

The EvolutionHD™ System is configured with a generous 750 GB hard drive available for video storage.

The EvolutionHD™ is a Class I medical device intended to be used as an accessory to various surgical cameras to record video and static images during surgical procedures and operations. The EvolutionHD™ is not intended for use with radiological imaging or diagnostic systems or in any function other than what is outlined in this manual. The EvolutionHD™ system has no patient applied parts and has not been investigated for patient connection.

BACKUP YOUR VIDEOS AND STILL IMAGES PERIDOCIALLY TO EXTERNAL STORAGE. THE EVOLUTION HD™ IS NOT INTENDED FOR LONG TERM STORAGE/ARCHIVING.

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QUICK INSTALL

CONTENTS

Upon receiving the EvolutionHD™, the following contents should be in the box: • • • •

1 - EvolutionHD™ 1 - User Manual 1 - Keyboard 1 - Remote

• • • •

1 - Power Supply 1 - DVI to DVI cable 1 - DVI to HDMI cable 1 - Medical Grade Power Cable

ACCESSORY CONNECTIONS FRONT

Figure 1 and Figure 2 detail the EvolutionHD™ accessory connections.

Note: Pressing and holding the Toolbar/Back button acts as a back button taking the user to the previous screen.

FIGURE 1

Note: Spinning USB hard disk drives that utilize the USB port for power (they have no power cable plugged into a wall outlet) should ONLY be connected to the FRONT USB port.

EvolutionHD™ Front

Capture

Screen

Enter

Left

Right

Capture

EvolutionHD™

Record

Up

Record

Enter

Toolbar

Toolbar/Back

Home

Down

Home

USB

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Power

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QUICK INSTALL (CONTINUED)

ACCESSORY CONNECTIONS BACK

Figure 2 shows the correct locations for connecting EvolutionHD™ accessories.

Note: IMPORTANT do not use a USB powered hard drive with the back USB ports

FIGURE 2

EvolutionHD™ Back Foot Pedal

DC In

HDMI Out (mirrors the integrated display)

DVI In

(3G) HD-SDI or Composite

S-Video

LAN

VGA

Microphone

USB (2)

GPIO

Accessories should only be connected as shown and/or described below: •

The EvolutionHD™ suppor ts specific Television resolutions via the HDMI Output connection. When the Graphical User Interface (GUI) is active, the EvolutionHD™ HDMI Output displays 1280 x 720p 60hz on the HDMI Output connected Television. The Television that is to be connected to the HDMI Output Connection must support the appropriate resolutions to properly display both the GUI (1280 x 720 p 6 0 hz) and live vide o from the chosen camera. When the Live Video is displayed, the HDMI Output connection displays the resolution of the source camera (see the chart on the right).

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Camera Resolution

HDMI Connected Television Must Support

1080p 50/59.94/60hz

1920 x 1080p 50/60hz

1080i 50/59.94/60hz

1920 x 1080i 50/60hz

720p 50/59.94/60hz

1280 x 720p 50/60hz

480i 50/59.94/60hz

720 x 480p 50/60hz

576i 50/59.94/60hz

720 x 576p 50/60hz

QUICK INSTALL (CONTINUED)

•

To connect a monitor, attach a HDMI Cable from the EvolutionHD™ HDMI Out to the Monitor In.

•

If a microphone is to be used, it should be connected to the microphone jack.

•

Any video device that is to be used for capturing video, should be connected to one of the 3 video capture inputs: DVI, HD-SDI, S-Video or Composite.

•

Only the power supply that is shipped with the E v o l u t i o n H D™ s h o u l d b e u s e d to p o w e r t h e EvolutionHD™. The power supply is a GlobTek Medical Power Supply: GTM21097-3005. Unplugging this power supply will completely isolate the EvolutionHD™ from the electrical energy source. Do not position the EvolutionHD™ in such a way to make it difficult to unplug the power supply.

•

A n a p p r o p r i a te U P S b a t te r y b a c k - u p /s u r g e protector is recommended if the system is placed in an environment where electrical dropout, spike, or brownout can occur.

VGA

The VGA output is used for previewing previously taken still captures. The VGA output will normally output the user interface at all times. When in live video mode, the VGA output will display all previously taken still captures. The previously taken still captures will be formatted into either a 1x1, 2x2, or 3x3 grid as configured in the settings. In addition to previewing stills, it will also indicate buffered stills as well as provide a progress bar indicating the current size of the buffer and the total number of stills needed to flush the buffer. When returning from live video mode, the VGA will output the user interface. Common setups for the live video (HDMI) combined with the previously taken still preview (VGA) are as follows: 1. Connect both HDMI and VGA outputs into one monitor, and configure the HDMI output to display with the VGA output configured as PIP (Picture-In-Picture). This will allow users to view the live video, with the previously taken still captures displayed in the PIP box. Note: It is common for monitors to only support S-Video for PIP, so a VGA to S-Video converter may be required. 2. Connect the live video (HDMI) into a primary monitor designated for live preview. Connect the still preview (VGA) to a secondary monitor.

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NEW CASE

Clicking the New Case button brings up the New Case and Work List screen. From here, it is possible to add cases to the Work List or create a New Case.

1. From the Home screen, click New Case (Figure 3).

TO CREATE A NEW CASE

3. On the next screen, fill out the appropriate Fields.

The quickest way to start a new case is to simply press the Record button. This will automatically start a new case (if a current case isn’t already open) and will auto name the case. Additionally, the “Live” icon on the homescreen can be selected and then press the record button. To manually begin a new case will all of the data filled out, follow the steps to the right:

4. Clicking Archive will open an option to store to a remote location (see “Location Selector” on page for more information). 5. Clicking Save will save the case and add it to the Work List for later use. 6. Or, click Save and Start to start using the new case immediately as the Current Case.

FIGURE 3

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2. On the Work List screen, click New Case.

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NEW CASE (CONTINUED)

ADDITIONAL OPTIONS WHEN CREATING A NEW CASE

1. The procedure selector is a dropdown list used to populate the “Procedure id” and “Procedure Description” f ields (se e Patient Fields on page) for the stored procedures on the system (Figure 4). Once a procedure has been chosen and the values have been populated, they may be changed from the default.

2. The auto print / archive / archive location values are populated from either system level settings (if no physician is selected) or physician level settings (if a physician is selected). These values can be changed from the default values per case.

FIGURE 4

USING THE WORK LIST

When a New Case is saved, but not started immediately, it is added to the Work list for later use. Cases in the Work list can choose from the following options (Figure 5):

1. Save and Start – start the case as the Current Case. 2. Edit – edit the information originally entered into the Fields when the case was created. 3. Delete – delete the case.

FIGURE 5

4. Save – return back to the Work list.

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NEW CASE (CONTINUED)

ADDING A CASE FROM MWL

MWL requires DICOM Modality Work list to be enabled from the settings on the EvolutionHD™. Using Modality Work list the EvolutionHD™ can use a centrally managed Work list. To add a case from MWL (Figure 6): 1. Navigate the Work list page and select the Add from MWL button. Press the Enter button on the front of the EvolutionHD™. Note: Cases from today’s list will be displayed by default.

Note: Cases may be filtered through the Filter settings (Modality, Study Date: All, Today, This Week, This Month) at the top of the page. Select Clear Filters to show all MWL cases. 3. The case information will pre populate the page. Press the Save button. 4. The desired case has now been added to the Work list on the EvolutionHD™.

FIGURE 6

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2. Navigate down to the desired MWL case, highlight the case and press the Enter button.

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NEW CASE (CONTINUED)

CURRENT CASE

When a Case is selected from the Work List, it becomes the Current Case (Figure 7). The Current Case is used to store new video recordings and new still image captures. The Home screen will display information about the Current Case such as the Patient Name, the Physician, the Procedure, the Number of Stills captured, and the Number of Videos recorded. When a Current Case is active, if the New Case button is pressed, it will close the Current Case before starting the New Case.

FIGURE 7

CLOSE

The Close button is only accessible when a Current Case is active (Figure 8). The Close button will close the Current Case and move its files to the Review screen. It will also print remaining still images if Auto Print is enabled. To Close the Current Case, press Toolbar, highlight Close and press the Enter button.

FIGURE 8

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LIVE

Clicking the Live button brings up the current live input signal. From here it is possible to take still captures or to record video.

TO TAKE A STILL CAPTURE

Click the top left button labeled Capture. An image will be created with the contents of the screen at the time the button is pressed. If the Capture button is pressed while the user is on the home screen; the software will go to the Live view of default Camera Input and then capture a still.

TO RECORD VIDEO

Click the top right button labeled Record. A video will be recorded, capturing what is on-screen at the time. The indicator light next to the Record button will light up red when the system is recording. Clicking the Record button again will stop the recording. Clicking the Record button further will create additional video recordings. Additional video recordings will be saved as separate files within the same case.

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TO CHANGE THE VIDEO INPUT SIGNAL

Press the Left or Right arrows to cycle through the available vide o inputs (DV I, DV I -A nalog , S -V ide o, Composite, & SDI). Additionally, the DVI and SDI inputs can change the color spacing by pressing either the Up or Down arrows.

REVIEW

Clicking the Review button brings up past cases for review. From here, it is possible to copy cases to an external drive, delete cases, append a case, or review a case’s media items.

COPY CASES (POST CASE)

To Copy Cases to an external drive (Figure 9): 1. Connect the external drive where the copied files will be located.

7. Check the DCIM Format option if using the iPad Camera Connection Kit to transfer files to the iPad. When using DCIM, Secure Zip and Include Patient Data are disabled.

2. Highlight a case and double press the Enter button.

8. Select a location to copy cases to (see Location Selector on page).

3. Repeat Step 2 for all cases to be copied.

9. Highlight the Copy button and press the Enter button.

4. Press the Toolbar button.

10. The copy progress displays two bars. The top bar is individual file progress. The bottom bar is overall progress.

5. Highlight Copy and press the Enter button. 6. The Copy screen has optional features to Include Patient Data or copy to a Secure Zip file. Click the checkbox next to either desired feature.

FIGURE 9

11. After copy, a list of all files successfully copied are shown. 12. Highlight the Ok and press the Enter button to close the Copy screen.

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REVIEW (CONTINUED)

TO DELETE CASES

1. Highlight a case and double press the Enter button (Figure 10). 2. Repeat Step 1 for all cases to be deleted. 3. Additionally, use the on-screen All button to select all cases or the None button to deselect all cases if needed. 4. Highlight Delete and press the Enter button. 5. A warning will pop up requesting confirmation to delete the case(s). Select Delete and press the Enter button to permanently delete the case(s) and their media. Select Cancel to cancel the delete operation.

FIGURE 10

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REVIEW (CONTINUED)

APPEND CASES

To Append a Case (Figure 11):

4. Edit any fields for the case with their new information.

1. Highlight the case to be appended and press the Enter button.

5. Save will save the changes and load the case into the Work List for future use.

2. Additionally, use the on-screen All button to select all cases or the None button to deselect all cases if needed.

6. Save and Start will save the changes and load the case as the Current Case. This allows the user to add additional video recordings and still images to the previously created case.

3. On the next screen, highlight Append and press the Enter button.

FIGURE 11

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REVIEW (CONTINUED)

VIEW MEDIA ITEMS

To Access the View Screen (Figure 12): 1. Highlight the case to be reviewed and press the Enter button. The View screen allows for Media Items to be Reviewed, Copied or Deleted, Annotations to be added, and Still Images to be Printed.

FIGURE 12

TO REVIEW A MEDIA ITEM

1. Highlight the thumbnail to be reviewed and press the Enter button (Figure 13). 2. Still Images will be displayed in the large Preview Panel upon review.

FIGURE 13

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3. Videos will start playing upon review. The playback feature can be paused with the Play/Pause button and can restart at the beginning with the Start Over button. 4. Press the Fullscreen button for a fullscreen view of either still images or videos.

REVIEW (CONTINUED)

TO SELECT ITEMS

1. Media Items can be selected individually on their respective Review screens (Figure 14).

3. To Select all Media Items, press the Toolbar button to access the on-screen toolbar.

2. Media Items can also be selected from the review screen by highlighting an item and double pressing the Enter button.

4. Select All and press the Enter button.

FIGURE 14

TO DESELECT ITEMS

1. Media Items can be deselected individually on their respective Review screens by pressing the Deselect button. Media Items can also be deselected from the review screen by highlighting and double pressing the Enter button. 2. Or, if all selected Media Items are to be deselected, press the Toolbar button. 3. Highlight None and press the Enter button.

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REVIEW (CONTINUED)

TO COPY MEDIA ITEMS

1. Highlight a Media Item and press the Enter button (Figure 15). 2. On the next screen, highlight Select, and press the Enter button. 3. Highlight Done and press the Enter button. 4. Repeat Steps 1-3 for all Media Items to be copied. 5. Selected items now have a blue checkbox over their thumbnails. 6. Connect the external drive where the copied files will be located.

FIGURE 15

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7. Press the Toolbar button. 8. Highlight Copy and press the Enter button. 9. The Copy screen has optional features to Include Patient Data or copy to a Secure Zip file. Click the checkbox next to either desired feature. 10. Check the DCIM Format option if using the iPad Camera Connection Kit to transfer files to the iPad. 11. Select a location to copy cases to (see Location Selector on page). 12. Highlight the Copy button and press the Enter button.

REVIEW (CONTINUED)

TO DELETE MEDIA ITEMS

1. Highlight a Media Item and press the Enter button (Figure 16).

5. Selected items now have a blue checkbox over their thumbnails.

2. On the next screen, highlight Select, and press the Enter button.

6. Press the Toolbar button.

3. Highlight Done and press the Enter button. 4. Repeat Steps 1-3 for all Media Items to be deleted.

FIGURE 16

7. Highlight Delete and press the Enter button. 8. A warning will pop up requesting confirmation to delete the file(s). Select Delete and press the Enter button to permanently delete the file(s). Select Cancel to cancel the delete operation.

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REVIEW (CONTINUED)

TO ANNOTATE MEDIA ITEMS

A keyboard is necessary to annotate media items. If needed, connect a keyboard to the EvolutionHD™ prior to completing the following steps. 1. Highlight a video or still capture and press the Enter button (Figure 17). 2. Highlight the Annotation field at the very bottom of the screen. A previously stored annotation will auto populate if present.

FIGURE 17

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3. Enter the annotation text with the keyboard. 4. If a case is assigned to a physician, the user can check the checkbox to save the annotation for future use. 5. Highlight Done by pressing the Down button, then press the Enter button. The Annotation is now saved to the media. 6. Annotated media thumbnails will now display a purple icon badge on the View Screen.

REVIEW (CONTINUED)

TO PRINT STILL IMAGES

1. Highlight a Still Image and press the Enter button (Figure 18). (Optionally, the user can double press the Enter Button to remain on the View Screen and select multiple images). 2. On the next screen, Select is highlighted by default. Press the enter button. 3. Press the Down button until Done is highlighted, then press the Enter button.

6. Press the Toolbar button to move to on screen toolbar. 7. Highlight Print and press the Enter button. 8. Press the Enter button to change the layout option. Use the Up/Down button to highlight an option and then press the Enter button. 9. Enter the Number of Copies to print using the keyboard.

4. Repeat Steps 1-3 for all Still Images to be printed.

10. Select the printer for the print job using the Enter button.

5. Selected items now have a blue checkbox over their thumbnails.

11. Highlight Print and press the Enter button or Cancel to cancel the print job.

FIGURE 18

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