4KLARITY User Manual Jan 2016.pdf
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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
Page 3
TABLE OF CONTENTS
INTRODUCTION4
About the 4Klarity4
Features4
QUICK INSTALL
5
WORK LIST
6
Contents5
Work List Page6
Work List Page Controls6
Patient Study Information7
Creating a Case on the Work List Page8
Starting a Case from the Work List Page9
Deleting a Case from the Work List Page in Local
Work List configuration9
Filter Work List10
Adding Cases from a DICOM Modality Work List10
RECORD11
Creating a Case on the Record Page11
Record Page Controls12
Capturing Video12
Capturing Still Images12
REVIEW13
Review Page13
Review Page Views13
Review Page Controls13
Filter by Patient Study Field Criteria15
Print Page15
Print Page Controls15
Copy Page16
Copy Page Controls16
Location Page17
Location Page Controls17
SETUP18
Setup Page18
General Tab18
System Sub Tab
18
Camera Sub Tab
19
Network Sub Tab
20
Configure HotSpot Button
20
Regional Sub Tab
20
Manual Sub Tab
21
Work List Tab
21
DICOM Storage Tab
22
DICOM Storage
23
DICOM Storage Commitment
23
Patient Fields Tab
24
Procedures Tab
24
Annotations Tab25
Case Checklist Tab25
Activity Log Tab25
Users Tab27
My Settings Tab27
Annotations Sub Tab27
Procedures Sub Tab28
Printing Sub Tab28
Media Sub Tab29
Location Information30
Patient Fields Sub Tab31
Software Recovery31
Backup Settings and Data31
TECHNICAL32
4Klarity Product Specifications32
Symbol Glossary33
SAFETY/ELECTRICAL/MAINTENANCE34
Technical34
System34
Connecting System to Power34
Classifications34
Notes35
Warranty35
SYSTEM COMPLIANCE STATEMENTS
36
CONTACT INFORMATION
40
System Compliance Statements & Tables36
IEC 60601-1-2:2007 Table 1 Requirements36
IEC 60601-1-2:2007 Table 2 Requirements37
IEC 60601-1-2:2007 Table 6 Requirements38
Additional39
Manufacturer Contact Information USA40
Authorized Representative Europe40
Authorized Representative Australia40
Notes40
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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.
•
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:
•
1 - 4Klarity Video Recording System
•
1 - 6’ DisplayPort to DVI cable
•
1 - User Manual Download Card
•
2 - 3.5mm Stereo cables
•
1 - USB Keyboard with built-in touch pad
•
4 - 6’ 3G HD-SDI 75 OHM cables
•
1 - 10’ Medical Grade Power cable
•
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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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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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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