4KLARITY User Manual Jan 2016

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USER MANUAL

Model: 4Klarity™

U5021-01, 2.0 2016-01-03

MEDXCHANGE.COM

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USER MANUAL

Model: 4Klarity™

U5021-01, 2.0 2016-01-03

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INTRODUCTION

ABOUT THE 4KLARITY

FEATURES

The 4 Klarit y is a complete medical recording and

do cumentation system that c an c apture 4 K UHD

video/images (3840x2160), 1080p 3D video and 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.

It is a Class I medical device intended to be used as an

accessory to various surgical cameras to record video

and capture images during surgical procedures and

operations. It is not intended for use with radiological

imaging or diagnostic systems or in any function other

than what is outlined in this manual.

The system has no patent applied parts and has not

been investigated for patent connection.

BACK UP VIDEOS AND IMAGES TO EXTERNAL

STORAGE PERIODICALLY; THIS SYSTEM IS NOT A

LONG TERM STORAGE OR ARCHIVING DEVICE.

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4K UHD & 1080p simultaneous display and capture

from 2 independent video sources

5x 1080p simultaneous video capture (recorded

fps may vary)

1080p 3D video capture

iOS/Android wireless application for live still images,

recording 4K video (via USB), Surgical Reports and

media review

Full touch screen monitor compatibility

DICOM Modality/Local Patient Work List

DICOM Storage and network case archive

Single 3G HD -SDI for additional 1080p camera

source

SuperSpeed USB 3.0 (up to 5gbps) connections for

fast file transfers

Integrated 802.11ac WiFi

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QUICK INSTALL

CONTENTS

Upon receiving the 4Klarity, the following contents

should be in the box:

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1 - 4Klarity Video Recording System

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1 - 6’ DisplayPort to DVI cable

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1 - User Manual Download Card

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2 - 3.5mm Stereo cables

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1 - USB Keyboard with built-in touch pad

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4 - 6’ 3G HD-SDI 75 OHM cables

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1 - 10’ Medical Grade Power cable

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2 - Dual-Band WiFi Dipole Antennas

4KLARITY FRONT

Hard Drive Activity Light

USB 3.0

Power & Power Activity Light

4KLARITY BACK

Potential Equalization Terminal

Serial

HD In

HD Out

N/A

USB 2.0

AC Source

GPIO

4K In/3D In/4SDI

USB 3.0

Main Output

Secondary Output

Microphone Input

Main Audio 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 Study 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 Study Information and begin a case, or

to enter as much Patient Study 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 Study 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 Study 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 Study Date

for the present day.

Start Case Button - begins the case that is presently

entered into the Patient Study Information or selected

in the Work List.

Save Button - saves the case that is presently entered

into the Patient Study Information to the Local Work List.

New Button - clears all information entered into the

Patient Study Information, restores all preset default

values to the Patient Study 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 S tudy

Information Fields to enable the user to see all of the

cases and data in the Work List and in the Patient Study

Information sections of the Work List Page.

Scroll Bar Arrow Buttons - move the Scroll Bars in small

increments.

On Screen Keyboard (OSK ) - enters Patient S tudy

Information.

Patient S tudy Information Tex t Boxes - create a

collection of patient demographics that are associated

with a case to be created.

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WORK LIST (CONTINUED)

PATIENT STUDY INFORMATION

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).

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 demographic information is entered here to

create a case (Figure 1-1). Patient Study Fields may be

resorted, 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).

FIGURE 1-1

FIGURE 1-2

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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).

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 Study Date field with the

present date and time each time a new patient entry

is started. The Study Date can be edited and changed

to a future date if desired. If the Study 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

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WORK LIST (CONTINUED)

STARTING 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).

1.

2.

3.

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 Study 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 Study Information or add media to a

case that was previously created with the software, the

Review Page offers this function (Review Page). Patient

Study Information in cases that were started from MWL

may be edited but it is not recommended.

DELETING A CASE FROM THE WORK LIST PAGE

IN LOCAL WORK LIST CONFIGURATION

When in Local Work List mode, the user has the ability

to delete cases from the Work List. Deleting a case from

the Work List Page is only possible in Local Work List

Mode (Figure 4).

1.

2.

3.

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 Study 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 default Patient Study

Information Field, by date range, and by cases scheduled

for the present date (default). Click the Today’s Work

List Button at any time to revert back to viewing only

the cases scheduled for the present date (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, S tudy Date, and Modality.

Search results can also be filtered by any native patient

field (Figure 6-1). Additionally, Administrators may apply

an AE Title filter on the Work List Setup page (Figure 6-2).

FIGURE 6-1

FIGURE 6-2

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RECORD

CREATING A CASE ON THE RECORD PAGE

Users may begin a case on the Record Page at any time

(Record Page can be the first page by choosing “None”

under the Work List Setting on the Setup Page). Patient

Study 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 Study 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 moves

the curser down to the next Patient 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 Study 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).

The System populates the Study Date field with the

present date and time each time a new patient entry

is started. The Study Date can be edited and changed

to a future date if desired. If the Study 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).

FIGURE 7-1

FIGURE 7-2

FIGURE 7-3

To begin a case without Patient Study Information:

1. Use GUI controls, scope commands, Endoscope

triggers or foot pedal commands to capture media.

2. Use the Information Tab ‘Edit’ Button to add or edit

Patient Study Information any time while a case is

in progress (Figure 7-3).

3. Clicking the Close Case button will save all entered

data and captured media items on the Review Page

(Figure 7-3).

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RECORD (CONTINUED)

RECORD PAGE CONTROLS

CAPTURING VIDEO

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.

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 maximum Segment Length by default.

FIGURE 8

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

Archive Succeeded

Information Tab - displays the Patient Study Information

for the case in progress. Click the Edit Button to alter

the Patient Study 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.

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 Dual Capture is

enabled, a still image from both connected sources will

be captured (Media Sub Tab).

Record/Pause But ton - initiates and ends a video

segment. A red dot appears to indicate capture is in

progress.

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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

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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.

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 S tudy

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.

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.

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 Study Information of the corresponding

surgical case.

Append Button - gives user the option to reopen the

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.

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.

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REVIEW (CONTINUED)

DICOM Button - sends a selected case the preset 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 the media item.

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.

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.

Select Annotated Button - selects all annotated case

media for copy, burn, or delete.

.25x Button - slows video playback to 25% of full speed.

Select None Button - deselects all selected media items.

.50x Button - slows video playback to 50% of full speed.

Print Button - print still images or save images to a PDF.

Normal Button - returns video playback to full speed.

Copy Button - navigates to the Copy Page to duplicate

case media to external media or network folders.

Capture Button - captures a still image from the video

displayed.

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.

Loop Button - when activated the selected video repeats

playback until stopped. Looped playback is activated

by default.

DICOM Button - sends a selected media item to the

preset DICOM Storage server when clicked.

Seek Bar - click and drag the dot on the Seek Bar to

navigate to a desired place in the video displayed.

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REVIEW (CONTINUED)

FILTER BY PATIENT STUDY FIELD CRITERIA

PRINT PAGE CONTROLS

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).

Print Preview Navigation Buttons - used to display each

page of a multiple page print job.

FIGURE 10

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 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.

PRINT PAGE

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 a list of printers 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 a number of Patient

Study 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

Include Annotations Checkbox - when activated the

print job will include annotations under the images.

Header Text Box - add text here to add a header or a

title for all of the pages in the present print job.

Logo Checkbox - when activated the print job will include

a preselected logo at the top of the pages.

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 Study

Fields to be added to the present print job.

Footer 1-6 - used to set the specified Patient Study 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 ha n c e me nt s E na b le d - when activated, the

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

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 preset image color, brightness, contrast,

and sharpen adjustments.

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.

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 size

of the media to be transferred, and the percentage

of completion of the present copy job. The user can

optionally copy the case into a password protected zip

file (Figure 12). 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

Copies - adjusts the number of copies for the present

print job.

Print Button - sends the print job to the specified printer

with all of the preset printing options.

Save as PDF Button - saves the print job to a PDF file

all of the preset printing options.

Exit Button - closes the Print Page without sending the

present print job.

COPY PAGE CONTROLS

Include Patient Data Checkbox - when activated the

Patient Study Information will be included in a text file

for each case that is copied to external media or network

location.

Secure Zip Checkbox - when activated the software will

copy the case to the specified location in a ZIP file that

can optionally be password protected. The password

can be set on the Setup Page > My Settings Tab > Media

Sub Tab (Media Sub Tab).

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, network.

Eject Button - used to safely eject a USB device after a

copy job has completed.

Abort - used to cancel a copy job in progress.

Exit - closes the Copy Page.

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REVIEW (CONTINUED)

LOCATION PAGE

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

LOCATION PAGE CONTROLS

An arrow will appear to the left of the dropdown when

a copy location becomes available.

Removable Drives 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

protocol. Authentication with network location must be

specified using the ‘Connect to UNC Button’ first.

C o n n e c t t o U N C B u t t o n - e nte r a n e t wo r 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.

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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.

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, 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 trash bin, customize

settings such as enabling or disabling procedures and

annotations, 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 set tings and User Manual. The

General Tab is displayed by first when the user navigates

to the Setup Page (Figure 14).

FIGURE 14

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.

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.

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 permanently, bypassing the trash bin.

Mute System Audio Checkbox - deactivates the audible

feedback when a still image is captured and when a

video is started or stopped.

Enable OSK Checkbox - enable or disable the automatic

popup of the On Screen Keyboard. This control is

activated by default. With this setting enabled, users

may still activate the On Screen Keyboard with the icon

on the application status bar.

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SETUP (CONTINUED)

CAMERA SUB TAB

Enable Application Status Bar - (disabled 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.

FIGURE 15

The Camera Sub Tab contains controls for the camera

inputs. Inputs may be disabled, renamed, or set as the

default (Figure 16).

Channel Configuration - a drop down menu to change

the t ype of configuration for the 4 K capture card.

Choose between 4K, 4SDI or 3D. Changing the channel

configuration requires a reboot to take effect.

4K - choose this option when using a 4K camera source.

4 S DI - choose this option to conver t the four 4 K

connections to independent HD 1080P inputs.

3 D - c h o o s e t h i s o pt i o n to u s e t h e f i r s t t wo 4 K

connections to a Side by Side 1080P 3D input.

Video Input Source Label Text Boxes - add a custom

label to each Video Input Source Button on the Record

Page. There is a 13 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 or Dual Channel Recording.

FIGURE 16

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SETUP (CONTINUED)

NETWORK SUB TAB

CONFIGURE HOTSPOT BUTTON

The Network Sub Tab contains settings that allow the

user to view and admins adjust Internet Protocol version

4 (IPv4) settings. IPv6 is not supported (Figure 17).

SSID - configure the name of the dedicated wireless

HotSpot.

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.

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 4Klarity. Use this

feature in conjunction with the MedXStream mobile app

when there is no wireless or wired network available.

If a wired or wireless network is available, this feature

should be disabled.

FIGURE 17

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Key - configure the passcode to join the wireless

HotSpot.

REGIONAL SUB TAB

The Regional Sub Tab contains settings that allow the

user to adjust the system time and date, time zone,

language and time/date format (Figure 18).

Date/Time Text Box - used to adjust the system time

and date. Enter a date and time then click the ‘Save’

button to adjust the time and date.

Time Zone Dropdown - sets the time zone. (UTC -5:00)

Eastern Time (US & Canada) is the default setting.

Changing the time zone will automatically adjust the

current time.

Language Dropdown - sets the display and keyboard

language. Available languages are Arabic, Chinese

(Traditional), German, English, Spanish, French, Italian,

Japanese, Korean, Portuguese, Russian, Swedish, and

Turkish.

Culture Dropdown - sets user interface to use the date

and time format common to the specified region.

FIGURE 18

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SETUP (CONTINUED)

MANUAL SUB TAB

WORK LIST TAB

The Manual Sub Tab displays the User Manual (Figure

19).

The Work List Tab contains options for configuring

4Klarity workflow. Local, MWL and None options are

available (Figure 20).

Zoom Dropdown - adjust the size of the User Manual

pages.

Export Manual Button - This allows the user manual to

be copied to an external location in PDF format.

Page Down Button - navigates to the next page.

Page Up Button - navigates to the previous page.

Search Button - search the manual for keywords.

FIGURE 19

Local Work List Sub Tab (default) - allows users to enter

and save patient information to begin cases quickly in

the future.

Modality Work List Sub Tab (MWL) - configure the

4Klarity to search for and add patient information from

a remote DICOM Modality Work List server. Unscheduled

cases can still be created, saved and completed locally.

MWL Sub Tab Controls:

Filter By AE Title - allows only cases assigned to the

specified Application Entity Title to be displayed in the

MWL search. Leave the filter empty to see the complete

Work List items with any Application Entity Title.

Server 1-4 Sub Tabs - used to configure connection

settings and select from one of four servers to be the

default DICOM Work List Server.

Diagnosing Checkbox - (disabled default) enables

verbose logging of DICOM communication to

troubleshoot DICOM failures. This option should remain

unchecked during normal operation.

View Log Button - opens a window to view DICOM

activity log. One log is created for both MWL and DICOM

Storage.

Server Sub Tab Controls:

Host IP Address - enter the IP address of the Work

List server.

Port - enter the port number used to communicate with

the Work List server.

Calling AE Title - enter the Application Entity Title

selected.

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SETUP (CONTINUED)

DICOM STORAGE TAB

Called AE Title - enter the Application Entity Title of

the Work List server.

Test Connection Button - used to perform a verification

with the Modality Work List server using the selected

settings, also known as a ‘DICOM Ping.’

FIGURE 20

The DICOM Storage Tab contains all of the controls and

settings used to enable copy and storage of surgical

cases to a DICOM Storage Server (Figure 21).

Single Frame Compression Mode Dropdown (Implicit

VR Little Endian default) - selects the compression

mode for images to be sent to DICOM storage.

Multiframe Mode - choose between MP4 and MPEG2

formats for DICOM video transfer. Consult the PACS

Conformance Statement to know what is supported.

Choosing MPEG2 requires time to convert the video file

from MP4 prior to transfer to PACS.

Store Video Checkbox - activates DICOM video file

storage in addition to image storage.

Enable Auto Store - activates sending cases to DICOM

Storage at case close without user intervention.

Enable Notification - displays a notification of media

items sent upon auto store.

Diagnosing Checkbox - (disabled default) enables

verbose logging of DICOM communication to

troubleshoot DICOM failures. This option should remain

unchecked during normal operation.

View Log Button - opens a window to view DICOM

activity log. One log is created for both MWL and DICOM

Storage.

Host IP Address Text Box - enter the IP address of the

Work List server.

Port - enter the port number used to communicate with

the Work List server.

Calling AE Title - enter the Application Entity Title of

the 4Klarity.

Called AE Title - enter the Application Entity Title of

the Storage server.

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SETUP (CONTINUED)

DICOM STORAGE COMMITMENT

Test Connection Button - used to perform a verification

with the DICOM S torage Ser ver using the selected

settings, also known as a ‘DICOM Ping.’

FIGURE 21

DICOM Storage Commitment is a service that lets the

modality verify if files that were sent to the PACS have

indeed been stored (Figure 22). Images, videos and/

or entire cases will be moved to the user’s trash bin on

the next boot after a successful commitment. Checking

the box will Consult with the PACS administrator to

determine whether to use a separate association or not.

Enable Storage Commitment - enables or disabled

the commitment feature.

Separate Association - perform the commitment

DICOM STORAGE

A Storage Server can be set up by an admin to upload

media items created on the 4Klarity, to a PACS or VNA

via DICOM protocol. While Storage Ser ver and auto

store is enabled, the system can automatically transmit

media items to the Selected Server upon close of the

active case. Conversely, users may choose to manually

upload case media to the Selected Server on the Review

Page after the case has been completed. Notification of

media items sent is always displayed when performing a

manual send. The 4Klarity keeps track of stored media

items and prevents users from storing duplicate cases on

the Storage Server. The Clear DICOM History Button may

be used in the event media items must be transmitted

again (General Tab).

Note: Before implementing DICOM Storage, the Med X

Change , Inc. DICOM Conformance Statement should

be reviewed to determine basic interoperability with

the storage server.

services on an association separate from the request of

DICOM store. When using separate association, specify

the IP address of the 4Klarity and port number 105 in

the AE title on the commitment SCP server.

H o s t I P Ad d re s s - e nte r th e IP address of th e

Commitment server.

Port - enter the port number used to communicate with

the Commitment server.

Calling AE Title - enter the Application Entity Title of

the 4Klarity.

Called AE Title - enter the Application Entity Title of

the Commitment server.

Te s t C o n n e c t i o n B u t to n - us e d to p e r fo r m a

verification with the DICOM Storage server using the

selected settings, also known as a ‘DICOM Ping.’

Test Commitment - used to perform a verification

with the DICOM Commitment server using the selected

settings.

FIGURE 22

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Page 24

SETUP (CONTINUED)

PATIENT FIELDS TAB

PROCEDURES TAB

The Patient Fields Tab controls what Patient Information

Fields are visible on the Work List Page, set to be

required to start a surgical case, and the default values

for Patient Information Fields (Figure 23). The default

Patient Information Fields are displayed on the Tab with

checkboxes that tell the user if the Patient Information

Field is required or not required, and visible or not visible.

An Administrator can click the Manage Button on any

of the Patient Information Fields to Update the Patient

Field the Display Name, Data Type, Default Value and

to set the Patient Information Field as required or not

required, and visible or not visible.

The Procedures Tab contains the list of Procedure

Descriptions, their associated Procedure ID, specialty

and sub -specialty (Figure 24). Admins may make a

custom list of Procedure IDs and associated Procedure

Descriptions commonly used in their practice. When

entering Patient Study Information, stored Procedures

may be selected from the Procedure Description and the

Procedure ID Dropdowns in the Patient Study Information

on the Work List Page.

Add Proce dure But ton - used to create a new

Procedure Description and associated Procedure ID.

Specialty and sub-specialty must be specified.

Patient Fields Tab Controls:

Arrow Up and Down Buttons - used to reorder the

Import Procedures - allows the import of a procedures

Patient Information Fields on the Work List and Review

Pages. Select a field and then click the Arrow Buttons to

move the field up or down the list. The list order from top

to bottom on the Patient Fields Tab will order from left to

right side of the page on the Work List and Review Page.

list from an external drive.

Required and Enabled Checkboxes - display the

Required and Enabled status of the corresponding

Patient Information Field. These settings can be altered

by clicking the Manage Button.

FIGURE 23

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PG024

E x p o r t P ro c e d u re s - all ows th e e x p o r t of th e

procedures list to backup, or import into another 4Klarity.

Edit Button - used to alter the Specialty, Subspecialty,

Procedure Description and associated Procedure ID.

Delete Button - erases the procedure.

FIGURE 24

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SETUP (CONTINUED)

ANNOTATIONS TAB

CASE CHECKLIST TAB

The Annotations Tab allows the user to manage text

annotations to be used for image annotations and the

Voice to Text Annotation feature (Figure 25).

Add Annotation Button - use the Add Annotation

The Case Checklist Tab allows the Admin to enable the

feature of the Case Checklist Screen. The checklist

requires certain questions to be answered/acknowledged

before the user can start a case. The Admin can add,

import, export, enable, edit and delete questions; this

is often called ‘Time- Out’ (Figure 26).

Button to create a new Annotation.

FIGURE 26

Annotation Tab Controls:

I m p o r t A n n ot at io n s - allows the imp or t of an

annotation list from an external drive.

E xpor t A n notations - allows the expor t of the

annotation list for backup, or import into another 4Klarity.

Edit Button - use to edit the Annotation and Shared

status.

Delete Button - deletes the Annotation.

FIGURE 25

ACTIVITY LOG TAB

The Activit y Log Tab is an auditing feature of the

software. It allows Admins to review, search, filter and

print the activity of the software based on the user that

was logged in (Figure 27). The Admin can see activity

logs for all users; a user can only see their activity. The

following triggers are used to populate the log:

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

Files imported into a case

Camera display name changed

Camera disabled

Camera enabled

Secondary input changed

Record full screen video layout changed

PIP layout changed

Default input changed

HotSpot enabled

HotSpot disabled

Case remotely edited

Auto login as Admin enabled

Auto login as Admin disabled

Case media items remotely deleted

Case remotely deleted

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