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ManoViewTM CLT

Analysis Software

Version 3.0

User Guide

DOC-2615-03May 2016

COPYRIGHT & TRADEMARKS

© 2001-2016 Given Imaging Ltd. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

Given Imaging15 Hampshire Street, Mansfield, MA 02048 [email protected]

Medtronic B.V.Earl Bakkenstraat 10,6422 PJ Heerlen, The Netherlands

Rx Only

ManoView CLT i User Guide

Table of Contents

Chapter 1: Introduction............................................................ 1

Welcome to ManoView ...................................................................................... 1

Product Intent...................................................................................................... 1

Audience ................................................................................................ 1

Indications for Use ................................................................................. 1

Contraindications of Use ........................................................................ 2

Intended Use .......................................................................................... 2

Warnings and Cautions .......................................................................... 2

Chapter 2: Menu Options and Controls ................................. 3

File Menu............................................................................................................ 3

Study Manager .................................................................................................... 4

Advanced Options (Filtered Searches) .................................................. 6

View Menu ......................................................................................................... 6

Setup Menu ......................................................................................................... 7

Report and Analysis Screen ................................................................... 7

Saving and Loading User Preferences ................................................... 9

Tools Menu ......................................................................................................... 9

Smart Mouse ........................................................................................ 10

Save Selected Data ............................................................................... 11

Chapter 3: Analysis Screen................................................... 12

Main Display..................................................................................................... 12

Analysis Screen Controls.................................................................................. 13

Pressure Profile ................................................................................................. 14

Data Display Panel............................................................................................ 15

Chapter 4: Frame Editing and Navigation............................ 16

Guidelines for Using Measurement Frames ..................................................... 16

Inserting, Removing, and Editing Frames ........................................................ 17

ManoView CLT ii User Guide

Inserting and Removing a Frame ......................................................... 17

On/Off Frame ....................................................................................... 17

Moving and Resizing a Frame ............................................................. 18

Navigation Bar and Time Controls ................................................................... 18

The Guide Wizard............................................................................................. 19

Chapter 5: Analysis Workflow............................................... 20

General Workflow Guidelines .......................................................................... 20

Specific Workflows .......................................................................................... 21

Anorectal Manometry .......................................................................... 21

Esophageal Manometry ........................................................................ 23

Sphincter of Oddi Manometry ............................................................. 24

Antroduodenal Manometry .................................................................. 26

Colonic Manometry ............................................................................. 26

Chapter 6: Report Screen...................................................... 27

Report Screen and Controls .............................................................................. 27

Report Screen Organization ................................................................. 27

Customized Drop-down Lists .............................................................. 28

Create Report ....................................................................................... 29

Normal Values .................................................................................................. 30

Chapter 7: Analytical Parameter Notes ................................ 31

Anorectal Manometry ....................................................................................... 31

General Notes ....................................................................................... 31

Analysis Parameter Description ........................................................... 32

Algorithms ........................................................................................... 33

Contraction Identification ........................................................... 33

Relaxation Identification ............................................................ 33

Esophageal Manometry .................................................................................... 34

General Notes ....................................................................................... 34

Analysis Parameter Description ........................................................... 34

Antroduodenal and Colonic Manometry .......................................................... 36

Sphincter of Oddi Manometry ......................................................................... 36

Chapter 8: HIS (Hospital Information System) .................... 37

ManoView CLT 1 User Guide

Chapter 1

Introduction

Welcome to ManoView

The ManoViewTM CLT analysis program is a graphical tool for analyzing the conventional

line trace pressure studies acquired through ManoScan® acquisition software. ManoScan

software is part of the ManoScan system, which includes catheters and devices for

performing manometry measurement.

This user guide describes ManoView CLT Analysis Program and its use.

Product Intent

AudienceThis user guide is intended for the trained medical personnel using ManoView CLT. All

users should have basic familiarity with Microsoft Windows.

Indications for UseThe ManoScan system provides mapping of pressures and, optionally, impedance within

organs of the human gastrointestinal tract. These include the pharynx, upper esophageal

sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, sphincter of

Oddi, small bowel, colon, duodenum, and anorectal organs. It is used in a medical clinical

setting to acquire pressures and then store the corresponding data for visualization and

analysis. The real-time data as well as the analysis information can be viewed by

medically-trained personnel for diagnostic and analytic purposes. The ManoScan HRM

modules provide high-resolution and/or 3D (three dimensional) display of the pressure

and impedance data. The ManoScan CLT module provides conventional line trace

mapping of the pressure data and can be used as a stand-alone system or as a module of the

ManoScan High-Resolution manometry system.


Contraindications of UseThe use of the ManoScan system for pharyngeal/esophageal motility study and proximal

gut (gastric/duodenal) manometry is contraindicated for the following:

• patients with an inability to tolerate nasal intubation.

• patients with significant bleeding disorders for whom nasal intubation is

contraindicated.

• patients with a known esophageal obstruction preventing passage of the instrument.

The use of the ManoScan system for anorectal manometry is contraindicated for patients

with known anal stricture/obstruction preventing insertion of the instrument.

Intended Use The ManoView CLT software program is a component of the ManoScan system. It is a

tool for analyzing the pressure and video data acquired during ManoScan procedures.

ManoView CLT allows medical personnel to analyze quantitative results and reference

images, and to generate reports.

ManoView CLT supports analysis of manometry studies that use conventional air-charged,

water-perfused, or solid-state catheters. It supports the following manometry procedures:

esophageal, anorectal, Sphincter of Oddi, antroduodenal, and colonic.

Warnings and CautionsManoView CLT is a component of the ManoScan system and is intended to be used by

trained medical personnel only. ManoView CLT assists in the diagnostic process by

providing visualization and quantitative estimates of physiological parameters, but clinical

conclusions should not be made without proper medical training in the applicable fields.


Chapter 2

Menu Options and Controls

When you start ManoView, the Analysis screen appears. It contains these four main menu

selections at the top-left of the screen:

• File: file handling

• View: viewing data table

• Setup: analysis setup

• Tools: analysis tools

Each menu is listed below with its options and their functionality.

File Menu

The File menu supports file opening and saving in various formats.

Option Function

Open Opens the Study Manager from which a study or analysis file can be opened. See Study Manager on page 4.

Save Analysis Saves the current state of the analysis including original pressure, current parameter values, and report information (when applicable). A new analysis file is created as result of this operation.

Save w/o Pat. Info Saves the study without the patient name.

Create Report Opens the Report screen to generate a report.

Save Data Log Saves logged data in text format (selected via the Log Data control above the Current display field near the bottom of the screen). The log file includes all entries from each time Log Data was selected since the last log was saved or ManoView was started.

Exit Closes ManoView after prompting to save or delete unsaved files.


Study Manager

Studies are created and saved in ManoScan (the data acquisition application) and reviewed

in ManoView.

The Study Manager is the most efficient way to browse all existing studies. The Study

Manager scans the Study Repository folder (where the studies are saved, as defined in

Setup > Folder > Study Repository) and displays a table of available studies. The scan is

performed every time the Study Manager is opened, so that the table is current. If a file

stored in a different location is browsed (Open File button), the corresponding folder is

also scanned and all of its studies are added to the Study Manager table; however, such

folders are not scanned regularly.

To open the Study Manager, select File > Open. The controls on the Study Manager screen

are:

Note

While a study can be reviewed in ManoScan (through the Study

Manager), it cannot be modified. This protects the authenticity of the

original data saved during acquisition.

Option Function

Browse Opens the Open File screen to select a file not located in the Study Repository. Once opened, all files at the location are also added to Study Manager table.

Advanced Displays additional controls for searching and filtering studies in the list. Also allows customization of Study Manager fields (see Advanced Options (Filtered Searches) on page 6).

Delete Deletes a study file from Study Manager table. The file is not deleted from the PC.

Refresh Refreshes the Study Manager to remove studies from the table that are no longer available in their original locations.

Open Opens the selected study.

Cancel Closes the Study Manager.


Figure 1. Study Manager main screen


Advanced Options (Filtered Searches)You may specify criteria for up to three fields to filter the Study Manager table. This lets

you see only the files appropriate to your search. For example, specifying Gender:

Female as the filter displays only studies with female patients.

Figure 2. Filtered list

View Menu

The View Menu provides access to the Report screen and the All Data Table.

Option Function

All Data Table Opens the All Data Table screen.

Video Window Displays recorded video input during study. Requires the corresponding video file (.mvd) to be found.


Setup Menu

The Setup menu allows you to customize ManoView’s analysis preferences and settings to

be used during analysis and reports.

Report and Analysis ScreenSetup Report & Analysis screen (see Figure 3) lets you select which parameters are

displayed on the report and in the All Data Table. (Certain parameters are default and may

not be deselected.) To save the selected parameters in the settings, select Save as Default.

You can select one or more of these table layouts:

• Tabular Summary: this table is presented in the Report screen, and in the report

document when Basic Report is selected in the Create Report screen. The table

provides a summary of information taken from all measurement events and all

channels.

• Location View (anorectal manometry study only): this table displays the analysis

parameters in the report that are calculated at the same anatomical location. This is

useful for pull-through studies.

• Data Table: this table is presented in the Data Table screen and in the report

document when you select Detailed Parameter Table in the Create Report screen.

The table provides detailed calculations for each parameter for all channel events

and event frames.

Option Function

Report and Analysis Opens the Setup Report & Analysis screen to select which parameters to view during analysis and to include in the report (see Report and Analysis Screen on page 7).

Load and Save Settings See Saving and Loading User Preferences on page 9.

Site Info Opens the Set Site Information screen to save site information. The Site Information can be included in the report (upper left-hand corner).

File Naming Opens Setup File Naming screen to define the name format of study files.

Units Opens Setup Units screen to define the unit types for different parameters.

Languages Displays a list of languages for the user interface. When you change the language, the change takes effect the next time ManoView is launched.

Folders Opens a menu to select the default folder location for:

• Study Repository: folder to which the study file is saved. The Study Manager scans this folder to populate the study list.

• Report: folder to which the report file is saved.

• HIS Export: folder to which the patient report is saved for HIS (see HIS (Hospital Information System) on page 37).


Depending on the selection in the Setup Report & Analysis screen, a parameter is shown

in one of the above tables.

Figure 3. Setup Table screen


Saving and Loading User PreferencesYou can save the settings of the current display. These settings can later be reset.

ManoView always displays the data in the current configuration.

To change default setting or to create a custom configuration (for example, settings

appropriate for pharyngeal research):

1. Set the value of each of the controls in ManoView as desired (for example, set the

values of main display pressure range).

2. Select Setup > Save Settings.

3. Select a group of settings (for example, Main and Profile Display Options or Main

and Profile Display Range). You can select any combination of these.

4. Enter a name for the configuration and click Save.

To reload the settings, click Load Settings. ManoView immediately applies the settings

and displays the main display accordingly. If the current configuration is saved as default,

(Default.cft), ManoView starts in this state the next time it is launched. This allows you to

customize the start-up viewing configuration and have other viewing configurations for

specific needs.

Tools Menu

The Tools menu provides access to ManoView CLT’s analytical tools and allows

configuration of on-screen guidelines and markers.

Option Function

Clear Analysis Clears all analysis performed for the analysis file. This includes setting of position of anatomical landmark and analysis controls.

Smart Mouse Opens the Smart Mouse submenu with diagnostic tools available using the cursor (see Smart Mouse on page 10).

Display Mode Options Allows one or more of these display options to be selected:

• Show Catheter in Profile

• Show Measurement Frames On/Off: enables On and Off button left of navigation bar

• Show Peak and Valleys

Save Selected Data Allows saving of the pressure data visible on the main display. The data can be saved as a text file (.txt) or as ManoScan study format (.tls) (see Save Selected Data on page 11).

Insert Frame Inserts a specified measurement frame at that location of the time bar.

Remove Frame Removes any measurement event at that location of the time bar.


Smart MouseThe Smart Mouse tool provides analytical information by left-clicking the mouse. The

analytical data is redisplayed next to the cursor. The parameters are calculated within the

Region of Interest (ROI) defined by Begin Point (BP) and End Point (EP). Turn on the

Smart Mouse by clicking Smart Mouse button on the top panel.

When the Smart Mouse is activated, it supports "drag on line trace" actions. Click-and-

drag across any two points on same channel or different channel to draw the ROI for

which the analysis information is provided. If the two points are on different channels,

only the difference information is calculated and displayed (see Figure 4).

You can draw multiple SmartMouse regions on the screen by pinning existing regions of

interest by clicking the pin icon that appears when the cursor is on the top right corner of

the ROI or holding the Ctrl key down while drawing the ROI (click-and-drag).

Figure 4. ROI in trace mode

Goto Provides options to go to:

• previous frame (Tab)

• next frame (Shift + Tab)

• previous screen (Left)

• next screen (Right)

Option Function


Smart Mouse options are:

Save Selected DataA selected portion may be saved for subsequent review or to be imported into other

applications, such as Microsoft Excel or Matlab. Select the time duration for the desired

data by zooming into the data on the main display. You may then select Tools > Save

Selected and select a data file format:

• Text file: The range of data is saved as a tab-delimited text table where the rows are

the data records for each sample time. The first column contains the sample times,

and the subsequent columns contain the pressure values (mmHg) for each sensor in

the range selected from distal to proximal. The files are saved with a .txt extension.

• Patient examination file: The saved data can be reviewed in ManoView CLT

software. The files are saved with a .tls extension.

Group Parameter Explanation

Difference Info Distance

Velocity

Data Difference

Distance between EP and BP

Distance / duration

Data value difference between EP and BP

Min/Mean/Max Duration

Max

Mean

Min

Time difference between EP and BP

Maximum data value in ROI

Mean data value in ROI

Minimum data value in ROI

Amplitude/Basal Amplitude

Basal

Average of difference of local maxima (peaks) and local minima (valleys) in ROI

Average of local minima (valleys) in ROI

Frequency Frequency Number of local maxima per minute in ROI


Chapter 3

Analysis Screen

The Analysis screen provides several ways to access setup options and tools. Functions

are accessible through the menu system or on-screen control buttons; the more commonly-

used functions can be accessed either way.

Main Display

The main display shows pressure as a colored trace (up to 16 horizontal traces, depending

on the number of sensors in the catheter).

Figure 5. Analysis screen: main display

The vertical space for each trace is adjusted automatically to accommodate all displayed

traces. Each trace has a legend/control area at the left showing the current trace value (at

that location of the time bar), trace position, and the maximum/minimum scale selected for


the trace. To adjust the minimum and full-scale pressure ranges, click in the legend/control

area.

Analysis Screen Controls

The Analysis screen provides these control buttons:

Figure 6. Range screen

Control Button Function

Open Opens the Study Manager.

Capture Takes a picture (screen capture) of the current main display. This picture can be printed or saved in the report.

Report Activates the ManoView CLT Report screen (see Report Screen and Controls on page 27).

Data Table Opens the All Data Table screen showing detailed study data.

Play Scrolls the data horizontally.

SM (Smart Mouse) Toggles Smart Mouse functionality on and off.

On / Off Shows or hides the event frame on the main display for the purpose of analysis. A frame toggled Off is not removed from the study, but it is not analyzed, so that it does not affect report parameters. To delete frames permanently, select Tools > Remove Frame. The On / Off control is available only when enabled from Tools > Display Mode Options.

Video Opens a window that displays recorded video input during the study. This control button is available only for files with video data.

Range Provides the ability to adjust the range and baseline values for the individual traces or all traces. To open, click the channel control at the left in Line Trace mode. If the All Channels checkbox is selected, all traces are adjusted simultaneously. This control is also used to set the range for the Pressure Profile (see Figure 6).


Pressure Profile

The Pressure Profile Display (right pane) displays the spatial distribution of pressure

relative to the time bar. It also includes the spatial markers used in localizing anatomical

landmarks. Figure 7 displays examples of graphical variations of the configurations that

may be displayed using the Anatomy controls for an anorectal study.

Figure 7. Pressure profile panel

The Pressure Profile contains these control buttons:

Control Button Function

Position Reference Toggles the position shown on the display from one reference to another. The references available for each modality are:

• Esophageal: From Nares, From LES, Sensor Channel

• Antroduodenal: From Nares, Sensor Channel

• Anorectal: From Orifice, Sensor Channel

Range Provides a slider control for setting the pressure limits when the display is in Line Trace mode.

Anatomy Toggles the Anatomy view on and off.

Line trace pressure display with anorectal anatomy

Line trace pressure display without anatomy


Data Display Panel

The Data Panel displays the data for the current activities on screen, including:

• the time, position, and pressure of the channels displayed in the main display, at that

location of the time bar.

• the current measurement data if a measurement frame is open, or the Smart Mouse

data if the Smart Mouse is in use.

To save the data from this panel, click the Log Data button. The saved data log includes an

entry for each time the log data was selected since the last time the log file was saved or

ManoView opened.

Figure 8. Analysis window, Data Panel

To show or hide the data panels, click the Hide Data button in the upper right of this area.


Chapter 4

Frame Editing and Navigation

Using the Frame Editing tools, you can move the boundaries of measurement frames, add

new frames, or delete existing frames.

Guidelines for Using Measurement Frames

Measurement frames identify areas in the data record. These are usually special areas

needed to calculate diagnostic parameters. Some types of measurement frames can be

inserted in ManoScan during acquisition and then retrieved in ManoView when the study

file is reviewed. There are also event frames that mark when a specific event occurred

during the study. These event frames can be inserted in ManoView CLT:

Modality Available Analysis Frames Frame Insertion in ManoScan

Frame Insertion in ManoView

Esophageal • LES ID

• LES Relaxation

• Swallow

• UES Resting

• UES Relaxation

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

Anorectal • Rectal Baseline

• Resting Pressure

• Squeeze

• Balloon Fill

• Push

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

Sphincter of Oddi • Duodenal Baseline

• CBD Analysis

• PD Analysis

yes

no

no

yes

yes

yes

Antroduodenal • Phase III

• Fed Response

no

no

yes

yes


• To open a frame, click its title or use the open icon in the frame’s upper right

corner.

• You can also open a frame by double-clicking its symbol in the navigation bar (see

Navigation Bar and Time Controls on page 18). When open, a frame displays the

analysis markers that can be adjusted in that frame.

• To close a frame, click its title or use the close icon in their upper right corner.

• Only one frame may be open at a time.

• To move to the next frame, click the first right-arrow to the right of the

navigation bar or press Tab. If a frame is currently open, it closes and the next one is

automatically opened.

See Analysis Workflow on page 20 for a description of editing diagnostic parameter values

using the on-screen tools in the measurement frames.

Inserting, Removing, and Editing Frames

Inserting and Removing a FrameFrames can be inserted by moving the time bar to the desired location in the data record or

by selecting Tools > Insert Frame > [type of frame]. A frame can be removed by moving

the time bar over an existing frame and selecting Tools > Remove Frame.

On/Off FrameA frame can be toggled on or off by toggling the On/Off button on the bottom left of the

frame. Alternatively, the On/Off button near the navigation bar can be used to enable or

disable all frames on the display. Switching a frame off disables the event frame (that is,

Colonic • High Amplitude Propagating Complex

• Low Amplitude Propagating Complex

• Rectal Motor Complex

no

no

no

yes

yes

yes

Note

Make sure that the analysis markers are properly set relative to the

data in order for the program to report proper diagnostic parameter

values.

Modality Available Analysis Frames Frame Insertion in ManoScan

Frame Insertion in ManoView


excludes it from all analysis calculations). This can be used as alternative to Tools >

Remove Frame feature, which removes the frame permanently.

Moving and Resizing a FrameThe right and left sides of a measurement frame can be moved by left-clicking and

dragging the measurement to the desired location. This allows resizing or moving frames.

Resizing an event frame repositions the analysis markers within that frame to the

appropriate new positions auto-calculated by the software, even if the positions of the

analysis markers within the frame are already modified and set by the user.

Navigation Bar and Time Controls

The navigation bar lets you quickly move anywhere within the data record. As shown in

Figure 9, the navigation bar includes a slider that shows the width of the current main

display and its location in the record. Color-coded rectangular areas (frame symbols) show

the location of measurement frames. A dot marker in the center of each rectangle is red if

that frame has not been opened, yellow if it is currently open, and green if it has been

opened and closed. Use the arrow controls to navigate backward and forward through the

frames. You can also navigate by clicking (moves center of slider to click point) and

double-clicking (opens associated measurement frame). Use the time control to adjust the

width (duration) of data currently displayed.

Figure 9. Navigation Bar

Note

This feature is only available when enabled from Tools > Display

Mode Options > Show Measurement Frames On/Off.

time control

zoom in/out

go to the beginning

go to end

frame on/off previous frame

slider status or dot marker

next frame


The zoom bar allows you to increase and decrease the amount of information displayed on

the main display panel.

Figure 10. Zoom toolbar

Here are the zoom toolbar controls:

The Guide Wizard

The Guide wizard provides step-by-step instructions for performing a study. You can write

your own instructions to appear when a particular frame type is opened. The Guide wizard

can be used for training purpose. For more information about enabling this feature, contact

Given Imaging Customer Support.

Toolbar Control Function

Zoom In Zooms in the display width to half size (in seconds).

Zoom Out Zooms out the display width, doubling the size (in seconds).

Zoom Out Fully Zooms out the display to show all the data in a single view.

zoom in

zoom out

zoom out fully


Chapter 5

Analysis Workflow

General Workflow Guidelines

These are the steps for analyzing a study. This workflow is similar for all types of studies.

1. Navigate through each measurement frame of the study, starting from the beginning

of the study. Use the Tab key or the navigation bar to navigate between frames.

Insert, remove, or adjust frames as desired (see Frame Editing and Navigation on

page 16).

2. Open the first measurement frame for analysis by clicking open icon in the top

right of the frame. If applicable, adjust the position of anatomical landmarks from

the profile panel.

3. Add or remove analysis channels to be used for calculation. Use the plus and minus

controls associated with each event frame (see Figure 11).

4. Adjust the analysis controls associated with the frame. When a frame is opened,

software auto-sets the analysis controls within the frame. However, you must review

the controls and adjust them if needed. These controls affect the calculation of report

analysis parameters.

5. Repeat the steps 2 to 4 for each measurement frame. When all measurement frames

are analyzed, click the Report button to generate a report.

Figure 11. Adding and removing channels


Specific Workflows

This section discusses specific analysis workflow details related to each type of study. For

a description of analysis parameters and their calculations, see Analytical Parameter Notes

on page 31.

Anorectal Manometry

1. Navigate through each measurement frame. Insert, remove, or adjust frames as

desired.

2. Open a Rectal Baseline frame. If needed, adjust the rectal pressure value for each

channel by moving the triangle control up and down.

Figure 12. Rectal Baseline frame

The rectal pressure value derived from a Rectal Baseline frame is used to calculate

certain parameters (such as Resting Pressure - Rectal Reference), which depend on

rectal pressure value.

3. Open the first Resting Pressure frame.

a. If applicable, set the positions of Proximal, Distal sphincter boundary, and/or

Peak pressure marker in the profile panel. For instance, if pressure traces

indicate that Channel 1 is at proximal sphincter location, move the Prox marker

in the profile panel and place it at Channel 1.

b. If needed, adjust the resting pressure value for each channel by moving the

triangle analysis control up and down.

c. Use the plus and minus controls to include or exclude channels for resting

pressure analysis.

d. Repeat the above steps for other Resting Pressure frames when they appear in

the study.

4. Repeat the above steps for Squeeze event frames as well. There are many analysis

controls applicable to Squeeze (see Figure 13). If a contraction is not identified in a

move to adjust rectal pressure value


channel, the channel is excluded for analysis and no analysis control is shown. Use

the plus and minus controls to include or exclude channels for analysis.

Figure 13. Squeeze Frame values

5. Repeat the above steps for Balloon Fill event frames. The values indicated by

analysis controls are shown here:

Figure 14. Balloon Fill event frame

6. Repeat the above steps for Push event frames.

7. Once all event frames have been analyzed, proceed to report generation.

resting pressure

duration

mean

max

duration

resting pressure

residual


Esophageal Manometry

1. Navigate through each measurement frame. Insert, remove, or adjust frames as

desired.

2. An LES ID frame was inserted (as per the Guide's instruction) after each catheter

pull in ManoScan software as the catheter transversed from gastric region to the

esophagus. Thus, these frames carry the information be used to position the Gastric

pressure baseline, to position the LES and PIP anatomical landmarks, and to

calculate the LES resting pressure.

Open the LES ID frames one by one, and follow these steps in parallel:

a. Adjust the position of LLB, HPZ, PIP, and LUB markers by moving anatomical

markers in the profile panel (see Figure 15). For example, if pressure traces

indicate that Channel 4 is at LUB, move the corresponding marker in the profile

panel and place it at Channel 4.

Figure 15. Adjust markers

b. Adjust the value of minimum pressure (Channelmin) for each gastric channel by

moving the triangle control up and down. The Channelmin value does not

directly impact any calculation. Rather, minimum of Channelmin from all

frames is taken as Gastric Baseline pressure (shown as the red dashed line in

Figure 16), which in turn is used to calculate LES parameters (see Analysis

Parameter Description on page 32 for detail).

Figure 16. Adjust minimum pressure

c. LES Resting pressure is calculated at the HPZ location. If needed, adjust the

analysis controls displayed to alter the resting pressure value.

Note

The software auto-positions the LES Upper Border (LUB), LES Lower

Border (LLB), and High pressure zone (HPZ) markers by auto-

detection algorithms.

LUB

LLB

minimum pressure control

Gastric Baseline for study


3. LES Relaxation frame: if the Extended Guide feature was used in ManoScan

software, LES relaxation frames may be available in the study. If needed, adjust the

position of LES anatomical landmark in the profile panel. The software calculates

the LES relaxation pressure at the channel placed at HPZ.

4. Swallow frame analysis:

a. Open the analysis frame. The LES anatomical position set in LES ID frames are

inherited in these frames, assuming the catheter was not moved. If needed,

adjust the position of the anatomical markers in the profile panel to indicate the

updated sphincter position.

b. The channel located at HPZ is used for LES relaxation analysis.

c. The channels located above LUB are used for Esophageal wave propagation

analysis. Analysis controls can be modified to alter the wave characteristics (for

example, peristaltic or failed) as well as calculate wave propagation parameters.

5. UES Resting and Relaxation frame analysis: Open the frames one by one, and

position the UES marker to indicate where the UES resting and relaxation analysis is

to be performed. If needed, adjust values by moving analysis controls.


Sphincter of Oddi Manometry

1. Zoom the main display to the desired magnification. Use the left and right arrow

keys to navigate through the whole study. Adjust the Duodenal baseline frame or

insert CBD or PD event frames (depending on whether the Sphincter of Oddi

measurement was taken while pulling the catheter through common bile duct or

pancreatic duct).

2. Open the Duodenal baseline frame for analysis. If needed, adjust the duodenal

pressure value for each channel by moving the triangle control up and down. The

pressure value derived from the Duodenal baseline frame is used to calculate the

Basal Sphincter of Oddi pressure parameter, which is reported with respect to

duodenal pressure (see Figure 17).

Note

The LES relaxation analysis parameters are also calculated in Swallow

frames. The combined LES relaxation values from the two frame types

are presented in the Report Summary table.

Note

For a CBD or PD frame, the Duodenal baseline frame located before

the CBD/PD frame defines duodenal pressure to be used for

calculation.


Figure 17. Duodenal baseline frame

3. Open the CBD or PD frame. The 40 mmHg region above the Duodenal baseline

(derived from latest baseline frame) is shaded for visual purposes (see Figure 18).

Figure 18. CBD analysis frame

4. Open the frames one by one for analysis. If needed, adjust the analysis controls to

change value for analysis parameters. Use the plus and minus controls to include

and exclude channels for analysis.


Duodenal baseline

40 mmHg zone from Duodenal baseline derived from previous baseline frame


Antroduodenal Manometry

1. Zoom the main display to desired magnification. Use the left and right arrow keys to

navigate through the whole study. Insert the event frames Phase III MMC or Fed

Response while navigating.

2. Open the first Phase III MMC frame:

a. If applicable, set the position of Pylorus sphincter and/or Jejunum pointer in the

profile panel. For instance, if pressure traces indicate that Channel 3 is at

Pylorus, move the corresponding marker in the profile panel and place it at

Channel 3. Corresponding annotation is placed in the event frame that indicates

that marker position has been set. These locations define which channel is in

which part of the anatomy. The summary output in the report uses this

information to report parameter calculated for the Antrum and Duodenal

regions separately.

b. If needed, adjust the analysis controls to change value for wave amplitude and

duration parameters.

c. Use the plus and minus controls to include and exclude channels for analysis.

3. Repeat the above steps for all event frames. Once all event frames have been

analyzed, proceed to report generation.

Colonic Manometry

1. Zoom the main display to the desired magnification. Use the left and right arrow

keys to navigate through the study. Insert the event frames HAPC, LAPC, or RMC

while navigating.

2. Open the frames one by one for analysis. If needed, adjust the analysis controls to

change the value for wave amplitude and duration parameters. Use the plus and

minus controls to include or exclude channels for analysis.



Chapter 6

Report Screen

The ManoView CLT Analysis Report screen lets you customize and generate reports. You

can control which categories of information are included. Convenient drop-down lists let

you save and re-insert commonly used textual information and ICD codes. The particular

analysis parameters that are available in the report screen may be custom-specified with

the Setup Report & Analysis feature (see Setup Menu on page 7). After you review and

complete the on-screen report screen, ManoView generates a report document that can be

printed or saved in a separate file. The report data becomes part of the analysis file (.tla)

and is stored when the analysis file is saved.

Report Screen and Controls

Report Screen OrganizationThe Report screen consists of six information areas. Each may be included or excluded

from the report. Figure 19 identifies the areas in the Report screen.

• Site Info: provides site or medical facility information. This information is carried

over from the acquisition study file (saved from ManoScan) or may be specified in

the ManoScan CLT software from the Setup menu.

• Exam Info: provides patient, examination, and physician information. This

information comes from the study file (created in the ManoScan acquisition

software); the information may be edited here if needed.

• Analysis Tables: provides analysis parameters depending on the type of manometry

procedures being conducted.

• Procedure Description, Indications, Interpretations, Impressions: allows input

of the indicated information or a selection from a previously saved drop-down list.

• Signatory Physician: allows input of name, title, and affiliation of the signing

physician or a selection from a previously saved drop-down list.


Figure 19. Report Screen organization

Customized Drop-down ListsThe Report screen provides customizable drop-down lists to eliminate the need for re-

typing commonly used information. These lists are available in the Procedure

Description, Indications, Interpretations, Impressions, and Signatory Physician tabs.

Adding, accessing, and removing data is similar for each list. Below is an example of a

Procedure Description window with the drop-down list.

Figure 20. Procedure Description drop-down list

• Adding To Drop-down List: to create a Procedure Description, enter the desired

name (for example, Small Bowel Manometry) in the List Name field. Then type the

description in the Text Field and select Save.

Note

Selecting Save causes all text in the Text field to be saved under the

current list name.

exam information

site information

study data

procedure description

scroll bar


• Using An Existing Drop-down list: to use a previously saved description, select it

from the drop-down list and select Add from list. This adds the corresponding

information to the end of any text already in the Text field. If an additional selection

is made from the list, it is added at the current insertion point (where text would be

added if typed).

• Removing Drop-down List Elements: to delete a saved description, select it from

the list and select Delete.

• ICD Codes: ICD codes can be added or removed in the same way as described

above. To add a code, type in the code and descriptive title (for example, ICD:

564.02 [Constipation, outlet dysfunction]). This is the title that will appear on the

report in the corresponding text field. No other text should exist in the text field at

this time. Type the desired title to be listed by this code (for example, Constipation)

in the List Name field for the ICD code and select Save. To delete an ICD code,

select it from the list and select Delete.

Create ReportAfter entering the appropriate information in the report, select Create to generate the

report document. This activates the screen shown in Figure 21. Select the information to

be included in the report document. The Basic Report is the information selected in the

previous Report screen. The Detailed Parameter Table is the list of parameters derived

from every event frame (for example, Swallow). You can adjust the parameters included in

the report with the Setup Report & Analysis feature (see Setup Menu on page 7).

You can select plot images to be included in the report. These plot images contain both the

measurement frames and the screenshots taken using the Capture function of the main

display.


Figure 21. Create Report

You can select the layout of the report (for example, 1 Column or 2 Column) from the list.

You can also select how the report is generated (for example, as a Word .docx file or a

PDF .pdf file).

Select OK to generate the report. Once generated, you can print the report or save it in any

common document format.

Normal Values

You may specify your own normal values to be used for the analysis parameters. Different

normal values may be specified based on probe type and gender. The normal values are

displayed in the Report Form screen and the printed report document. For more

information about normal values, and assistance in implementing them, contact Given

Imaging Customer Support.


Chapter 7

Analytical Parameter Notes

Anorectal Manometry

General NotesRectal Baseline pressure: the minimum pressure within a Rectal Baseline frame for a

channel is calculated as the Rectal Baseline pressure for the channel. If multiple Rectal

Baseline frames are present, the minimum is used as a channel’s Rectal Baseline pressure

for the whole study.

Frame Resting Pressure: the Frame Resting Pressure for a channel is the 5-second

average before the beginning of the frame. The pressure increase for Squeeze and Push

frames are calculated with respect to Frame Resting Pressure (and not with respect to

resting pressure calculated from the Resting frame).

Note

The actual rectal pressure during Squeeze and Push maneuvers may

be significantly different from the pressure measured in the Rectal

Baseline frame. Therefore, use judgment if using the analysis

parameters for Squeeze or Push frames that are calculated based on

Rectal Baseline pressure (see Analysis Parameter Description on

page 32).


Analysis Parameter Description

Parameter Name Description

Anatomy Location

Length HPZ (cm) Distance between proximal and distal boundaries of anal sphincter

Verge to Center (cm) Distance from distal sphincter boundary to Peak pressure location

Resting

Resting Pressure (atmosph. Ref.)

Mean pressure within the Resting frame

Resting Pressure (baseline Ref.)

Resting Pressure (atmosph. Ref. – Rectal Baseline pressure)

Squeeze

Pressure Amplitude (atmosph. Ref.)

Maximum Pressure within the contraction duration

Pressure Amplitude (baseline Ref.)

Pressure Amplitude (atmosph. Ref. – Rectal Baseline pressure)

Pressure Increase (mmHg)

Pressure Amplitude (atmosph. Ref. – Frame Resting Pressure)

Contraction Power (mmHg)

Mean Pressure within the contraction duration

Contraction Duration (sec)

Duration of contraction calculated using the Contraction Identification Algorithm described in Algorithms on page 33

Push

Pressure Amplitude (Atmosph. Ref.)

Maximum Pressure within the contraction duration

Pressure Amplitude (Baseline Ref.)

Pressure Amplitude (atmosph. Ref. – Rectal Baseline pressure)

Pressure Increase (mmHg)

Pressure Amplitude (atmosph. Ref. – Frame Resting Pressure)

Contraction Power (mmHg)

Mean Pressure within the contraction duration

Contraction Duration (sec)

Duration of contraction calculated using Contraction Identification Algorithm described in Algorithms on page 33

Balloon Fill

Sensation (cc) The value of last balloon volume annotation entered by user before first sensation, first urge, or first discomfort annotation, respectivelyUrge (cc)

Discomfort (cc)

RAIR Presence Presence or absence of rectoanal inhibitory reflex as manually indicated by user for the RAIR flag

Reported in summary results as Present if it is present in any of the Balloon Fill frames


Algorithms

Contraction IdentificationContraction within Squeeze and Push frames is identified as follows:

1. When the pressure value with respect to Frame Resting Pressure exceeds the

threshold, it marks the start of a possible contraction.

2. When the pressure value with respect to Frame Resting Pressure falls below the

threshold, it marks the end of the possible contraction.

3. If the maximum pressure increase value (within this possible contraction period)

exceeds the minimum increase threshold, and the time between the start and end of

the possible contraction exceeds the minimum duration threshold, it is identified as a

contraction.

4. If multiple contractions are found, the one with the maximum time duration is saved

as contraction.

Relaxation IdentificationRAIR Relaxation within Balloon Fill frame is identified as follows

1. When the pressure value falls below the threshold, it marks the start of a possible

relaxation.

2. When the pressure value falls above the threshold or the end of the analysis marker

is met, it marks the end of the possible relaxation.

3. If the minimum pressure value (within this possible relaxation period) is lower than

the minimum decrease threshold, and the time between the start and end of the

possible relaxation exceeds the minimum duration threshold, it is identified as a

relaxation.

Percent Relaxation (1 - (Residual Pressure / Frame Resting Pressure)) * 100

Resting Pressure (mmHg)

See Resting Pressure, above

Residual Pressure (mmHg)

Minimum pressure within the Relaxation duration

Relaxation Duration (sec)

Duration of relaxation calculated using Relaxation Identification Algorithm described in Algorithms on page 33

Balloon Volume (cc) Taken from the Balloon Volume annotation previous to the frame



Esophageal Manometry

General NotesGastric baseline pressure: if Channelmin represents the minimum pressure for a channel

within an LES ID frame, the Gastric baseline at a channel is calculated as the minimum of

Channelmin calculated from all LES ID frames. Thus, no matter how many LES ID frames

there are in the study, there is only one Gastric baseline pressure associated with each

channel.

The Gastric baseline is displayed in software as a dashed red line running through the LES

ID frames. The Gastric baseline value impacts the LES resting and relaxation calculations

in LES ID, LES relaxation, and Swallow analysis frames.

Analysis Parameter Description


Anatomy Location

LES Lower Border LLB Marker location calculated from LES ID frame

LES Upper Border LUB Marker location calculated from LES ID frame

LES Total Length = LES Lower Border – LES Upper Border

Abdominal Length = LES Lower Border – PIP location (if negative, then zero)

Hernia Sac Length = PIP location – LES Lower Border (if negative, then zero)

UES Mid-point Location UES Marker location calculated from UES Resting and UES Relaxation frame

Esophageal Location = LES Upper Border – UES marker location

LES ID Frame

LES Resting Pressure (Respiratory Mean)

Mean for the channel within the frame, expressed with regards to Gastric baseline pressure

LES Resting Pressure - End Expiratory

Mean of local minima (valleys) for the channel within the frame, expressed with regards to Gastric baseline pressure

LES Relaxation Frame

LES Resting Pressure 5 sec mean taken at the LES channel before the beginning of the frame, expressed with regards to Gastric baseline pressure

LES Residual Pressure Minimum pressure taken at LES channel, expressed with regards to Gastric baseline pressure

LES Percent Relaxation (1 – (Residual Pressure / Resting Pressure)) * 100



Swallow Frame

Swallow Classification If Contraction identified in all channels:

• If Vel < 0.5: Failed (where Vel = positive value of peristaltic velocity between first and last esophageal channel)

• If Vel > 20: Simultaneous

• If Vel < 0: Retrograde

• Otherwise:

• Amplitude in at least one channel < 20 mmHg: Hypotensive

• Amplitude in at least one channel > 180 mmHg: Hypertensive

• Otherwise: Normal

If Contractions missing in at least 1 channel between proximal and distal, then Ineffective Esophageal Motility (IEM)

LES Resting Pressure

See description for LES Relaxation Frame, above.LES Residual Pressure

LES Percent Relaxation

Wave Amplitude Peak pressure for the channel – esophageal baseline pressure, where esophageal baseline pressure for the channel is calculated as 5 sec mean before the beginning of the frame

Wave Duration Duration of wave propagation

Onset Velocity Velocity calculated using time of onset of peristaltic wave on two neighboring channels

Time Propagation Time taken for wave to move from one channel to the next

UES Resting Analysis

UES Resting Pressure Mean pressure within the frame

UES Relaxation Analysis

UES Resting Pressure 5 sec mean taken at the UES channel before the beginning of the frame

UES Residual Pressure Minimum pressure taken at UES channel

UES Percentage Relaxation

(1 – (Residual Pressure / Resting Pressure)) * 100


Antroduodenal and Colonic Manometry

Most of the analysis parameters for Antroduodenal and Colonic manometry are common

to both types of procedures. These parameters are defined below.

Sphincter of Oddi Manometry

Note

Peak and Valley refer to local pressure maxima and minima,

respectively, detected within a frame.


Distance of propagation Distance between first and last channel where the contraction is identified

Propagation velocity Velocity of propagation

Number of peaks Number of pressure peaks during contraction duration

Contraction duration Duration of contraction

Contraction frequency Number of Peaks / Contraction Duration

Average Amplitude (mmHg) (Mean of peak pressure – Mean of valley pressure) within contraction duration

Motility Index Natural log of positive integral of the area within pressure curve during contraction duration, divided by time (in minutes)

MMC cycle time Parameter applicable to Antroduodenal manometry only. Defined as the time between end of a Phase III MMC frame and beginning of another Phase III MMC frame.

Note

Peak and Valley refer to local pressure maxima and minima,

respectively, detected within a frame.


Propagation Direction Flag (manually set by user)

1. Undefined

2. Peristaltic Hypertensive

3. Peristaltic Normal

4. Simultaneous

5. Retrograde

Duodenal Pressure Baseline pressure calculated from the closest previous Duodenal Baseline frame.

Basal SO Pressure Mean of Valley - Duodenal Pressure

Phasic Wave Amplitude Mean of Peak - Mean of Valley

Phasic Wave Frequency (peaks / min)

Number of Peaks / Total contraction duration in minutes


Chapter 8

HIS (Hospital Information

System)

This information is intended to be used by the IT professional responsible for maintaining

the HIS. ManoScan supports interfacing with an HIS. This allows the import of patient

information into ManoScan and the export of the study report from ManoView.

Figure 22. Data workflow between the ManoScan system and the HIS

ManoScan software accepts the patient information from an import file (.imp). ManoScan

looks in the folder specified in Folders > HIS Import every time it starts, and adds the

patients scheduled for procedure to the Patient Manager (accessible from the Patient

Information screen). Patient information is exported by ManoView to the HIS as an export

file (.exp), and the study report is exported as a PDF file (.pdf).

HIS

ManoScan

software

ManoView

software

patient information via .imp (import) file

ManoScan file (data + patient info)

patient info via .exp (export) file and .pdf (report) file


Here is the file structure for both the import and export file:

<study>

<patient>

<dob>1954-11-23</dob> //yyyy-mm-dd

<name>

<first>Ralph</first>

<last>Jefferson</last>

<middle>H</middle>

</name>

<gender>1</gender> //1 = Male, 0 = female

<height>1701</height> //in mm

<id>C98349A2</id>

<weight>70306</weight> // in gms

</patient>

<procedure>

<indications>Swallowing Problems</indications>

<procedure>Esophageal Manometry</procedure>

</procedure>

</study>

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