Reflux Software 6.1 UG...The landmarks can be manually adjusted based on the patient’s anatomy. Optionally, landmark information can be extracted from a previous manometry study

Reflux Software

&

Reflux Reader

Version 6.1

User Guide

EnglishDOC-2869-04March 2017

COPYRIGHT & TRADEMARKSCopyright ©2001–2017 Given Imaging Ltd. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. TM* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

The Reflux Software and Reflux Reader is part of the Digitrapper pH-Z and Bravo Reflux Testing System. The Digitrapper pH-Z and Bravo Reflux Testing System user guides should be referred to before using the system for data acquisition or diagnosis.

Bravo pH Monitoring System:This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Given Imaging 15 Hampshire StreetMansfield, MA [email protected]

Medtronic B.V.Earl Bakkenstraat 106422 PJ HeerlenThe Netherlands

Rx only

Reflux Software and Reflux Reader v6.1 i User Guide

Table of Contents

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

Welcome to Reflux Software ................................................. 1

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

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

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

Abbreviations Used................................................................ 2

Chapter 2: Getting Started ................................................ 3

System Requirements ........................................................... 3

Installing Reflux Software / Reflux Reader ............................ 3

Starting Reflux Software / Reflux Reader .............................. 3

Quick Start Using the Guide Wizard ...................................... 4

Uploading a Study .......................................................... 5

Entering Diary Information .............................................. 5

Viewing the Study ........................................................... 6

Creating the Report ........................................................ 7

Saving the Study ............................................................. 7

Chapter 3: Completing Setup ........................................... 8

Customizing the Settings ....................................................... 8

Setup Menu .................................................................... 8Setup Report & Analysis .................................................. 9

Event List ........................................................................ 10

Display Appearance ....................................................... 11

Protocol .......................................................................... 12

Setup Analysis ................................................................ 13

Reflux Software and Reflux Reader v6.1 ii User Guide

Chapter 4: Using Main Windows and Controls ............. 15

Study Manager .................................................................... 15Advanced Options (Filtered Searches) .......................... 16

Display Modes .............................................................. 18Contour Mode ................................................................. 18

Line Trace Mode ............................................................ 19

The Profile Display ........................................................ 20

Main Display Toolbar .................................................... 22

Setting the Data Range ................................................ 22

The Analysis Screen Menus ......................................... 23File Menu ........................................................................ 23

Setup Menu .................................................................... 24

Tools Menu ..................................................................... 24

Display Mode Options ................................................... 25

Navigation Bar ..................................................................... 25Miscellaneous Controls .................................................. 26

Chapter 5: Reviewing a Study ........................................ 27

Features Helpful for Reviewing Studies............................... 27Navigation ...................................................................... 27

Local Auto-range ............................................................ 28

Keyboard Shortcuts ........................................................ 29

Understanding and Editing Impedance Analysis Markers

29Impedance Episode Visualization .................................. 29

Impedance Episode Editing ............................................ 30

Gas Event Visualization and Editing .............................. 32

Reviewing the pH Data ................................................. 32

Reviewing the Impedance Data .................................... 33

Chapter 6: Reports........................................................... 36

Overview.............................................................................. 36

Modifying Reports................................................................ 37

Commonly-used Information................................................ 39

Reflux Software and Reflux Reader v6.1 iii User Guide

Creating Reports.................................................................. 39

Chapter 7: Advanced Features ....................................... 42Custom Report Template .............................................. 42

Choosing Study and Report Naming ............................ 43

Ability to Edit Analysis Protocol .................................... 43

Display and Report Customization ............................... 43

Guide Customization .................................................... 44Enable Dual-day Analysis for 96-hour Bravo Studies .... 44

Customizing Normal Values ........................................... 44

Automatic Deletion of Repeated Button Presses .......... 44

Increase Font Size of Main Display .............................. 44

Remove User Folder Names from HTML Report ......... 44

Chapter 8: Reflux Detection Algorithm.......................... 45Liquid Reflux/Swallow Detection ................................... 45

Gas Reflux Detection .................................................... 48

Chapter 9: Analysis Parameter Explanations ............... 49

Appendix: HIS (Hospital Information System) .............. 53

Reflux Software and Reflux Reader v6.1 1 User Guide

Chapter 1Introduction

Welcome to Reflux SoftwareReflux Software v6.1 and Reflux Reader v6.1 provide tools to efficiently analyze information obtained from the ambulatory reflux monitoring recorders (BravoTM and DigitrapperTM). This user guide describes the features and use of:

• Reflux Software: for upload and analysis of pH and pH-Z studies • Reflux Reader: for review of pH and pH-Z studies (does not include upload from

recorder or automated detection)

Product Intent

AudienceThis user guide is intended for the trained medical personnel. All users should have basic familiarity with Microsoft Windows.

Indications for Use• With Digitrapper pH-Z System: The Digitrapper pH-Z System is intended to

record, store, view, and analyze esophageal and gastric pH data (and, optionally, impedance levels) to diagnose reflux disorders.

• With Bravo pH Monitoring System: The Bravo Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo capsule can be attached following either endoscopy or manometry. The Reflux/Accuview software application is intended to record, store, view, and analyze gastroesophageal pH data.

NoteAny pH studies recorded with capsule–pH calibration not required can only be uploaded and reviewed with this version (v6.1) of Reflux Software.


Abbreviations Used

This user guide uses the following abbreviations:

Abbreviation Meaning

*.ava, *.avb file extension for Reflux Software Analysis data

cm centimeters

HIS Hospital Information System

LESd Lower Esophageal Sphincter Distal

LESp Lower Esophageal Sphincter Proximal

pH potential of hydrogen (measure of acidity)

PIP Pressure Inverse Point

s seconds

SAP Symptom Association Probability

SI Symptom Index

SSI Symptom Sensitivity Index

UES Upper Esophageal Sphincter

Z impedance (Ohms)


Chapter 2

Getting Started

This section describes installing and starting Reflux Software and Reflux Reader and

understanding its menus and controls.

System Requirements

Reflux Software can be installed on any PC that meets the minimum system requirements

as listed on the provided software media. These minimum system requirements and

installation instructions also apply to Reflux Reader.

Installing Reflux Software / Reflux Reader

To start the installation, follow the installation instructions on the software media.

During the installation process, you can select the interface language. The available

languages are listed the software media (default is English). You can also change the

interface language after installation from Setup > Language from the Reflux Software

main display.

Follow the on-screen prompts to complete the installation.

Starting Reflux Software / Reflux Reader

To start Reflux Software or Reflux Reader:

• double-click its icon on the Windows desktop, or

• select Reflux Software or Reflux Reader from the Windows program menu.


The main display appears without any patient study for the Reflux Software. If it is the

Reflux Reader, the Study Manager opens to allow study selection.

Figure 1. Reflux Software main display on opening

Quick Start Using the Guide Wizard

The Guide wizard is the easiest way to get started with the software. The Guide is a series

of screens that tell you what to do in the correct sequence. The Guide can be started by

clicking on Guide button on the toolbar. This section walks you through a typical work

flow followed through Guide. These steps can be executed independent of the Guide as

well by using appropriate controls on the software.

Figure 2. Using the Guide Wizard


Uploading a StudyA study stored in the recorder is first uploaded to the software. Connect the Digitrapper or

Bravo recorder to the computer via the provided USB cable. Initiate upload through the

Guide or by clicking the Upload button. The Upload progress bar appears.

Entering Diary Information

When the study data has been uploaded, the Edit Information & Diary screen

appears.

Figure 3. Edit Information and Diary screen

1. Make sure that the patient information is complete and correct. Data may have been

partially filled from your HIS (see HIS (Hospital Information System) on page 53).

2. Complete the study information (date, physician names, etc.).

Note

You cannot upload data with the Reflux Reader.


3. Select the protocol corresponding to the probe being used. Click Setup to navigate

to Setup Analysis screen to view the analysis setting being used. To use different

analysis settings, create a new protocol corresponding to the probe type.

4. If necessary, add or edit Symptoms and Events, or add comments to a Symptom or

Event.

5. Verify that all information is correct and click OK to save.

Viewing the StudyThe main display shows the uploaded data in a time plot of pH or pH/impedance. The

region above the main screen shows the events and symptoms on the same time scale as

the pH waveform, and the navigational bar below shows a compressed timescale with

each event and symptom identified by its designated color. The Event and Symptom

Markers on the Main Display can be dragged to modify the time of the events and

symptoms; the changes are automatically updated in the Diary. On the right side, the

profile display shows a depiction of the anatomy along with approximate sensor locations.

The landmarks can be manually adjusted based on the patient’s anatomy. Optionally,

landmark information can be extracted from a previous manometry study performed on

the same patient, using the menu below the anatomy.

For details about all the controls on the Main Display, see Completing Setup on page 8 and

Using Main Windows and Controls on page 15.

Figure 4. Study displayed in Main Display


Creating the ReportA report is printed results of a study. It includes details about the study, selected images,

any notes or comments inserted by the user, and the analysis results. To create the report,

click Report. The Report screen opens. You can review the analysis results and

information to be included in the report. The included information may be customized via

Report Parameters in the Setup menu (see Setup Report & Analysis on page 9). When

you have reviewed the report settings and made any necessary changes, click OK. The

report is then generated in the specified format (Microsoft Word, PDF, or HTML).

Figure 5. Report screen

Saving the StudyTo save patient analysis data at any time during the analysis process, select File > Save.

The study is saved in the folder specified through Folders > Study Repository under the

Setup menu.


Chapter 3

Completing Setup

This section describes the interface (menus and screens) of the Reflux Software and the

Reflux Reader, as well as how to configure them to meet your specific needs.

Customizing the Settings

Reflux Software has many settings that can be customized to better meet your pH and pH-

Z analysis and Reflux Reader needs. You can access these settings through the Setup

menu.

We recommend that you configure the applications before starting to use them. However,

you can always change settings later.

Setup MenuUse the Setup menu to customize Reflux Software settings, including analysis and report

preferences.

Option Function

Report Parameters Opens the Setup Report & Analysis screen to select the analysis parameters to be included in the report. For details, see Setup Report & Analysis on page 9.

Load Settings Whenever the application is opened, the settings named as Default are used. You can select other previously-saved settings in the Load Settings screen. The loaded settings are only applied to the current session. To make it the default to be applied every time the application is opened, select it as Default in the Save Settings screen.

Save Settings Saves currently selected settings (preferences), such as impedance & pH ranges, view configuration, and report settings. Settings can be saved as Default or any user-defined name.

Site Info Opens the Setup Site Information screen to input information about the clinical site (to be included in the report).

Units Opens the Units screen to change formats (date and time) and units of measurement (height and weight).

Event List Opens the Event List screen to customize symptoms and events available for selection in the diary. For details, see Event List on page 10.


Setup Report & AnalysisUse this setup screen to select the parameters that be displayed in report. These selections

apply to the current analysis, and saved as default settings.

Figure 6. Setup Report & Analysis screen

Display Appearance Opens the Display Appearance screen to set the default display mode and data range values. For details, see Display Appearance on page 11.

Protocol Opens the Protocol screen to create and configure study protocols, including probe type selection, probe channel placement specifics, and analysis settings. For details, see Protocol on page 12.

Language Allows selection of the user interface language

Folders Opens the Folders screen to set the location of the Study Repository, Report, HIS Import, and HIS Export folders. Study Repository is the folder where studies are saved.

Option Function


Event List Use this setup screen to identify which symptoms or patient position is to be included in

the report or main display. Only those symptoms selected (maximum six) will be used for

analysis.

To create custom symptoms, enter text in the blank field below the symptom list, then

press to add it to the list.

Medication events may be displayed as either Drug or Med. (In this guide, medication

events are displayed as Med.)

An option is included for Prone position to be included in the analysis and report for

infant or pediatric studies when the Boix-Ochoa score is reported. Except for Boix-Ochoa

score, the rest of analysis calculations in the Report will continue to not separate Prone

and Supine analysis.

Use the Bravo Button Association menu to set default events for buttons on the Bravo

recorder.

The button deletes any selected symptom from the list.


To apply the changes to the current study and save them as the future default, click Set As

Default.

Figure 7. Setup Event List

Display AppearanceUse this setup screen to set the display mode and channel ranges to be used as default

when the program starts.

Main Display includes adjustment of the range limits of both pH and Impedance. The

Impedance View Mode selects between Contour and Trace Mode.


Profile Display includes adjustment of the range limits of both pH and Impedance range in

the profile display. The Impedance View Mode selects between Contour and Trace Mode.

Figure 8. Setup Display Appearance

ProtocolThe term protocol or analysis protocol has been used in the software to designate the

probe placement and analysis settings. These settings are accessible through the Protocol

screen. One protocol, specific to each probe configuration type, is shipped along with the

software. You can create a new protocol if you intend to alter the probe placement or the

analysis settings. An existing protocol cannot be edited.

Perform the following steps to create a new protocol.

1. Type the name of the new protocol in the Protocol field. Try to use a short but

descriptive name that will help you identify the protocol easily in the future.

2. Verify the probe selection is correct. If incorrect, select the correct probe from the

Probe list.

3. Verify the placement is correct. Use placement controls to change each field as

needed.

4. To change analysis parameters, click Next. The Setup Analysis screen appears.

Note

Changing catheter placement from 5 cm to any other location removes

the standard scores (such as DeMeester Score) from the final report.


5. Click OK to complete creating a new protocol. Click OK to close the Setup

Analysis screen.

Figure 9. Setup Protocol

Setup AnalysisUse this setup screen to configure settings that affect data analysis and scoring in the

report. See the table following the figure for details.

Figure 10. Setup Analysis

pH Analysis

Analysis channel Selection of channel used for generic score, and for classifying impedance refluxes.

Acid threshold pH boundary for acid reflux (typically pH 4.0).

Minimum pH episode duration

The minimum pH duration in seconds that defines an acid reflux.

Long episode definition Long reflux episode setting duration in minutes.

Symptom Association

Include symptoms within The period, in seconds, after the end of an acid reflux episode within which a symptom will be associated with the episode.

Analyze pH episodes as reflux in impedance symptom (acid reflux) analysis

Enable or use of pH episodes in the impedance symptom analysis. If enabled, these episodes are classified as being acidic.


To return to factory defaults, click Restore Defaults.

Meals and Post Prandial

Meal periods Inclusion or exclusion of meal periods from analysis.

Post-prandial duration The duration used for post-prandial period analysis.

Impedance / Reflux Analysis

Bolus Calculation Channel. Channel used for calculation of Bolus exposure parameters like Bolus Exposure Time.

Acid limit (at or below) The pH level limit (at or below) for acid reflux.

Weakly acid/alkaline boundary

The pH level limit for distinction between weakly and non-acidic reflux.

Impedance / Reflux Detection

Impedance downward threshold

Percent of drop in impedance for identifying a start of an impedance episode.

Impedance return threshold Percent of return in impedance for identifying an end of an impedance episode.

No. distal channels for detection

The number of distal impedance channels included in reflux detection.

No. of proximal channels The number of proximal channels analyzed for the calculation of proximal reflux parameters. In typical cases, the lowest of the proximal channels is used for proximal calculation. However, in scenario where there is no drop detected on lowest proximal channel, the next proximal channel will be used.


Chapter 4

Using Main Windows and

Controls

Study Manager

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 > Folders > 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 (Browse button), the corresponding folder is also

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

are not scanned every time the software is opened.

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

are:

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 16.

Delete Deletes a study file from Study Manager table. The file is not shown in the Study Manager; however, to prevent data loss, 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 11. Study Manager

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.

The Main Display

The main display shows the data of an opened study as a time plot of pH or pH-Z. The

main display shows the study in two display modes, Contour (for pH-Z studies only) or

Line Trace mode. Contour mode provides a continuous space and time image of

impedance, while trace mode provides the impedance channel as a line trace.

The region above the main display shows the events and symptoms on the same time scale

as the pH waveform, and the navigational bar below shows the entire study time with each

event and symptom identified by its designated color.


The area on the right is the Profile Display, in which the approximate location for each

pressure and impedance channel is shown

Figure 12. Key Elements of the display screen (Main Display in Line Trace mode)


Figure 13. Main elements of the display (Main Display shown in Contour mode)

Display Modes

Contour ModeThe contour plot displays impedance encoded in color with sensor channel location along

the vertical axis and time along the horizontal axis. A color key on the left indicates the

corresponding impedance values in Ohms at each end of the color scale. The pH channel

waveform data is located at the bottom of the main display. The pH cutoff is displayed as a

horizontal blue line in the contour and pH waveform data display. The impedance reflux

classification markers are displayed towards the top of the main display to indicate acid

reflux (red triangle ), weakly-acidic reflux (yellow square ), and non-acidic reflux

(green triangle ).


To set minimum and maximum displayed impedance values, click the range/baseline

control located close to the color bar.

Figure 14. Contour Mode

Line Trace ModeThe line trace mode displays impedance or pH as a colored trace and accommodates up to

six horizontal traces for impedance and up to two traces for pH traces.

The vertical space allocated for each trace is adjusted automatically. The trace has a

legend/control area at the left showing the pH value at the time bar location and the

display range/baseline.


Figure 15. Line Trace

The Profile Display

The Impedance & pH Profile Display (right pane) shows the spatial distribution of the

measurements at the time bar. It also includes markers that are used to set anatomical

landmarks.


Figure 16. Examples of graphical variations of the configurations that may displayed using the Mode and Anatomy controls

The buttons at the bottom of the Profile window enables the following:

Button Function

Mode Toggles the Impedance display between line trace and color contour.

Anatomy Toggles on and off an anatomical depiction of the upper gastrointestinal tract.

Range Activates the screen for pH and impedance limit controls (see Setting the Data Range on page 22).

Line trace impedance & pH display with esophageal anatomy

Color contour impedance & pH display with esophageal anatomy

Line trace display without anatomy


Main Display ToolbarThe toolbar on the main display provides quick access to various controls for opening

files, uploading data, and accessing the study diary.

Figure 17. Toolbar on main display

Setting the Data Range

You can adjust the range for traces (either individually or for all traces at once when All

Channels is selected) using the Set Data Range sliders. This lets you set the minimum and

maximum impedance and pH levels. This feature is available in both Line Trace and

Contour mode. The Impedance value defaults to Auto-Range unless the main display

Button/Icon Function

Diary Opens the Diary screen to access patient and study information and to edit the protocol, symptoms, and events.

Open Opens the Study Manager.

Upload Uploads study data from recorder to PC. Recorder must be connected to the PC via a USB cable. See Starting Reflux Software / Reflux Reader on page 3.

Zoom In / Zoom Out Zoom adjustment of the main display.

When zooming in or out, the data position on the time bar remains unchanged.

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

Zoom to Default Display Duration

Sets the display duration to default. Note that the default needs to be set from the Tools > Set Default Display Duration to be able to use this button.

Add Exclusion Period Inserts a 30-minute exclusion period centered on the time bar. The exclusion duration may be extended or reduced further by dragging the edge of the exclusion border.

Delete Exclusion Period Deletes a previously-inserted exclusion period. Does not remove meal-associated exclusions, which are set and removed from the Setup Analysis screen.

Capture Captures (screen shot) of current view for inclusion in the report.

Report Opens the Report screen to create the study report.

Guide Opens the Guide Wizard


ranges are set in the Setup Display Appearance screen (see Completing Setup on page 8).

If Auto-Range is selected, the sliders are disabled.

Figure 18. Set Range sliders (top: pH-Z; bottom: pH)

To adjust the minimum and full-scale pH and impedance ranges, click the legend.

The Analysis Screen MenusMenus and their options vary depending on the application. This section describes the

menus in the Analysis screen.

File MenuThe File menu supports file opening, saving, and managing study data.

Option Function

Upload Data Uploads recorded data from the recorder. (This functionality is not available for the Reflux Reader.)

Open Opens the Study Manager.

Save Saves the data and analysis changes as a new study.

Save without Patient Info Save the study without the patient information

Diary Opens the Edit Information & Diary screen for entering or modifying patient information, study information, protocol selection or configuration, symptoms, and events. See Display Mode Options on page 25.

Export Selected as Text Exports the data visible on the main display as text.

Exit Closes all Reflux Software files and exits the application.


Setup MenuUse the Setup menu to customize application settings, including analysis and report

preferences. See Completing Setup on page 8.

Tools MenuThe Tools menu provides access to the application’s analytical tools. It also allows

configuration of on-screen guidelines and markers. The options available are different in

pH and pH-Z studies.

Option Function

Display Mode Options Provides various options to allow customization of the main display. See Display Mode Options on page 25 for details.

Goto Provides various options to navigate in the study.

Delete All Impedance Episodes

Deletes all impedance episode.

Re-detect Impedance Episodes

Re-detects the impedance episode.

Add/Delete Impedance Episode

Add/delete impedance episode at the instance where the time bar is placed.

Add Episode Top Channel Expands an impedance episode to the proximal impedance channel.

Delete Episode Top Channel Deletes the inclusion of the most proximal channel in an impedance episode.

Undo Impedance Episode When an impedance episode is modified (boundaries changed, channel added/deleted or episode deleted), Undo action restores all the channels of the episode to the state they were in before the episode was modified.

Undo only restores changes pertaining to the last modified episode.

Exclude pH Episode • Exclude pH episode at the instant where the time bar is placed. When excluded, the episode is not counted and the red fill is removed.

• For dual pH studies, allows to exclude episode for each channel independently.

Restore pH Episode • Restores an excluded pH episode.

• For dual pH studies, allows to restore episode for each channel independently.

Add/Delete Exclusion Period Add/delete exclusion period of 30 minutes duration centered at the time bar.

Add/Delete Nocturnal Baseline Period

Performs calculation of Mean Nocturnal Baseline Impedance (MNBI) output in report. Only the baseline periods inserted during Supine duration are used for calculation of MNBI. The boundaries of inserted baseline period can be edited by dragging its borders.


Display Mode Options

Navigation Bar

Use the navigation bar to move anywhere within the data record. It includes a slider that

shows the width of the current main display and location in the study. Each color and

shape identifies the event or symptoms along the entire study:

• Horizontal rectangular bars in different colors identify the meal periods and the

supine position periods.

• Grey diamonds identify various symptoms.

Set Default Display Duration Sets the current display duration as default. When the screen is navigated using the arrow keys, the display is reset to this default duration. This feature is useful during study review when user zooms in/out frequently, but wants to resume to a default magnification.

Option Function

Show pH Episode Numbers Shows/hides the pH reflux episode numbers in the main display.

Enable pH Trace on Contour Shows the pH trace corresponding to pH analysis channel on the impedance contour display. The lower limit of the pH range is depicted by a horizontal guideline.

Show pH Calculations Shows time duration, nadir value, and area under reflux for each pH reflux when zoomed in.

Hide Impedance Toggles the display of impedance data on the main display. When hidden, the pH data fills the entire main display.

Show Impedance Guidelines

Shows/hides the guidelines for all impedance channels in Contour mode.

Show Impedance Episode Numbers

Shows/hides the impedance episode numbers in the main display.

Show Reflux Shading Displays opaque color shading below the trace during impedance reflux episode.

Enable Full Trace Shading Displays transparent color shading extending full height of the channel during impedance reflux episode. This check box is to be selected in combination with the Show Reflux Shading check box.

Show Impedance Reflux Baseline

Displays the baseline for the impedance reflux.

Show Impedance Reflux Baseline Value

Displays the value of the impedance baseline for each reflux.

Show Traces Background Shows/hides the background color for both pH and impedance traces. When not selected, the background is set to white.

Option Function


• Purple diamonds mark when medications were taken.

• Shaded areas spanning the navigation bar height indicate analysis exclusion periods.

Their left and right edges define the time span within the study.

• The time range adjusts the width (time duration) of data currently displayed, similar

to the zoom tools.

• To move the time bracket, click-and-drag with the mouse.

Figure 19. Navigation bar

Miscellaneous Controls

Control Action

Display Mode Toggles between Contour and Trace mode (pH-Z only)

Play Plays the study simulating it like a video. Playback speed can be selected using the drop down menu.


Chapter 5

Reviewing a Study

Features Helpful for Reviewing Studies

This section discusses and highlights those features that are especially useful for pH or

pH-Z study review.

Navigation

You may navigate from one screen to next screen by dragging the Main Display with the

left click of the mouse. This can also be accomplished by means of left and right arrow

keys on the keyboard.

Hovering the mouse toward the left or right borders of the Main Display makes additional

navigation controls visible (see Figure 20 on page 28). You may navigate between

Symptom (Sx), Proximal impedance reflux (Prox), Distal impedance reflux (Dist), or pH

reflux (pH1) by using the corresponding controls.

All the above navigation functions can also be performed with keyboard shortcuts (see

Keyboard Shortcuts on page 29).

While reviewing impedance data, you may want to zooms in/out frequently, but will like

to resume to a default magnification. The feature Tools> Set Default Display Duration is

especially useful for this purpose. Zoom to the desired magnification (for example, 3

minutes) and press Set Default Display Duration. When the screen is navigated using the

arrow keys, the display will always get reset to this default duration. The default

magnification set can also be applied manually by pressing corresponding icon on the

Zoom toolbar.


Figure 20. Additional navigation controls (hover mouse near main display borders)

Local Auto-rangeImpedance data on the current display can be auto-ranged such that the traces for each

channel fit within the channel. This can be activated by pressing the Auto range labeled

control on the top of the Left Panel in Line Trace mode (see Figure 20 above). Keyboard

shortcut is also provided for this functionality..

Note

This is different from the auto-range option available through the

Range panel, which auto-ranges to optimize for the whole study, rather

than only the current display.


Keyboard ShortcutsThe table below list the keyboard shortcuts available for navigation and impedance data

review.

Understanding and Editing Impedance Analysis Markers

Impedance Episode VisualizationThe application automatically detects the drops in impedance baseline as per analysis

protocol and combines these drops into episodes. These episodes are internally classified

as liquid Reflux, Swallow, and Unknowns based on the overall direction of movement.

Reflux are labeled with a count. Swallow are not displayed to user at all. Unknowns are

not labeled (or counted), but are displayed so that user can move boundaries, if need be,

Keys Action

Right Arrow Go to next page.

Left Arrow Go to previous page.

Ctrl + W Local Auto-range.

Ctrl + Q Toggle between trace and contour displays.

Ctrl + mouse scroll forward Zoom in.

Ctrl + mouse scroll backward

Zoom out.

Ctrl + A Add an impedance episode.

Delete Delete an impedance episode.

+ Add top impedance episode channel.

- Remove top impedance episode channel.

Ctrl + Z Undo last edits to impedance episode.

Ctrl + 1 Go to next pH episode in channel 1.

Ctrl + Shift+1 Go to previous pH episode in channel 1.

Ctrl + 2 Go to next pH episode in channel 2.

Ctrl + Shift+2 Go to previous pH episode in channel 2.

Ctrl + D Go to next distal impedance episode.

Ctrl + Shift+ D Go to previous distal impedance episode.

Tab Go to next proximal impedance episode.

Shift + Tab Go to previous proximal impedance episode.

Ctrl + S Go to next symptom episode.

Ctrl + Shift+ S Go to previous symptom episode.

Ctrl + G Go to next Gas episode.

Ctrl + Shift + G Go to previous Gas episode.


and convert it into reflux with minimal efforts. See Figure 21 for a depiction of impedance

episodes on the main display trace mode.

Figure 21. Types of episodes (Impedance Reflux on left, Unknown episode on right)

Impedance Episode EditingFollowing operations are typically performed for editing impedance episodes:

• Boundary adjustment: by moving the left and right boundaries of episode in each

channel. Note that bolus exposure (distal) and proximal reflux parameters are

calculated only at the channels specified through analysis protocol (typically, Z5 and

Z2 respectively). Hence, as long as episode is correctly identified as reflux, user

may choose to skip adjusting boundaries for other channels (see Figure 22).

• Adding or deleting channel: if a reflux is to be extended to a proximal channel,

place the red time bar over the reflux, right-click and select Add Impedance

Episode Top Channel, or use the corresponding shortcut key. Similarly, Delete

Impedance Episode Top Channel deletes the topmost channel of the reflux located

beneath the time bar (see Figure 23). Adding or deleting channels can be done only

sequentially, one channel at a time.


Figure 22. Boundary Adjustment

In the above figure, only Z5 and Z2 participate in analysis calculations pertaining to bolus

or proximal reflux calculations. Hence, boundary adjustment can be skipped for other

channels. For the same reason, inserting an episode at Z4 can be skipped.

Figure 23. Adding/Deleting Channel

The above figure demonstrates placing the red time bar over the reflux on the left in order

to delete the top channel. The black filled dots (highlighted) indicate which channels are

associated with that reflux on the left. These dots are displayed when any of the episode

boundary is moved.

• Undo Impedance Episode changes: When an impedance episode is modified

(boundaries changed, channel added/deleted or episode deleted), Undo action

restores all the channels of the episode to the state they were in before the episode

was modified. Undo only restores changes pertaining to the last modified episode.


Gas Event Visualization and Editing Gas events detected by impedance data are depicted as yellow vertical line (see

Figure 24). If a gas event occurs during or immediately before liquid reflux, it is counted

as Mixed Reflux in the Reflux Composition table in the report. Gas events can be moved

by dragging the line on the main display. They can also be added or deleted by keyboard

shortcuts or from the Tools menu.

Figure 24. Gas event shown as yellow vertical line. Since, the gas event occurs during liquid reflux, this reflux will be counted as mixed reflux in analysis.

Reviewing the pH Data

1. Select Tools > Hide Impedance to hide impedance data for pH-Z study.

2. Zoom in the display to a comfortable magnification for reviewing the pH trace.

3. Review the pH trace(s) to determine if physiologically accurate and reflective of the

patient's history; navigate from screen to screen and ensure that:

• The pH baseline is not consistently at or below pH 4 for significant duration (possibly indicating catheter migration towards the stomach or capsule detachment). See Figure 25 below.

• The pH baseline is not consistently high to exclude non-physiological data from being analyzed. Place an exclusion zone by pressing the exclude icon on the toolbar. Data above pH 9 and below pH 0 will be automatically excluded.

Note

Hiding the impedance tracing is optional, but may provide a better

picture of the overall pH tracing.


Figure 25. Example of a pH probe placed too low in the esophagus

4. If a pH reflux is due to an artifact and is to be excluded, use Tools > Exclude pH

Episode option. This can also be accomplished by placing an exclusion zone.

5. If the probe was removed before the end of the study recording, make sure that the

data from the beginning of catheter removal to the end of the study has been

excluded. See Figure 26.

Figure 26. pH probe removed before end of study. This data must be excluded

Reviewing the Impedance Data

1. Select Tools > Display Mode > Hide Impedance, if the impedance data is hidden.

Impedance data can be viewed in Trace mode or Contour mode, depending on

preference. Typically, Contour mode allows easier identification of reflux, while

Trace mode allows better placement of reflux boundaries. You may toggle between

the two modes by pressing the Display Mode button, or by keyboard shortcut.

Note

Lower impedance baselines may be seen in some patient conditions,

such as Barrett’s esophagus.


Figure 27. Lower impedance reading in distal two-thirds of esophagus

2. Determine a comfortable viewing scale to view the data by using the zoom tools on

the toolbar on the top of the screen. Use the Time control box to the left of the

navigation bar to adjust the time scale. A time scale between 2–5 minutes is usually

optimal for viewing impedance data.

3. To add or delete an impedance episode, right-click and select Add Impedance

Episode or Delete Impedance Episode at any instance. Impedance-detected reflux

episodes can also be added or deleted from the Tools menu or through the keyboard

shortcuts.

4. To adjust the width of an episode at any channel location, click-and-drag the

boundary markers. The orientation of the left side markers to each other determines

whether an episode is considered anterograde or retrograde. See Figure 28. If half or

more pairs of channels have retrograde movement, the episode is identified as

reflux.

Figure 28. Contour mode showing anterograde (swallow) and retrograde (reflux) bolus movement


5. Use the mouse or keyboard shortcuts to navigate to each time segment of the study

to:

• Add/Remove impedance episodes as necessary

• Adjust impedance episode boundaries

• Add/Remove proximal episodes as needed

6. Observe symptom events as you review the study to get qualitative understanding of

the symptom-reflux association. Default analysis protocol setting is such that a

symptom that occurs within the 2 minutes after a reflux is considered associated

with the reflux.

7. Proceed to report creation when you are done reviewing the whole study.

Note

All bolus exposure and Proximal exposure calculations are performed

only at the channels set through Bolus calculation channel and no.

of proximal channels setting in the Setup Analysis screen. Thus,

fine tuning reflux boundaries of other channels does not impact the

analysis results.


Chapter 6

Reports

Overview

A report is the document containing selected analysis results and other information.

Choices made in the Setup Report & Analysis screen (see Setup Report & Analysis on

page 9) are the defaults of what will appear in a report, such as:

• summary plot

• procedure description

• interpretations/findings

• field for the clinician to sign

However, each report can be modified individually, selecting what information to include

or exclude.

After reviewing and completing the on-screen report form, a report document is generated

that may be printed, saved in a separate file, or exported (for example, by email). Once

you save a report, its data becomes part of the study and is stored when the analysis file is

saved.


Modifying Reports

The Report window consists of six information areas that can be included or excluded

from the report.

Figure 29. Report Form example

The areas are:

• Setup Site Information: provides site or medical facility information. This

information is specified in the Setup Site Information screen and may include

information from the original study file if different than the current settings.

• Include Patient Info: provides patient, examination, and physician information.

These can be edited from the Edit Information & Diary screen.

By de-selecting Patient Information, the patient’s name and identification number is

excluded from the created report (useful for safeguarding patient information in

exported reports).

• Analysis Tables and display options: tables corresponding to various analysis

parameters are presented in this section. The analysis parameters to be shown here is

set from Setup > Report Parameters screen. The first three tables, as labeled, are


the Summary tables; these summarizing important analysis parameters from rest of

the report. For multiple day study, day calculation for single day can be seen by

selecting appropriate day selection control (see Figure 31 below). Alternatively,

Combine Day Tables check box can be selected to see calculations for each day

combined together in single table. Note that these selections only control the result

presentation on the Report Form. The result presentation in the Report document is

customized from the Create Report screen.

Figure 30. Day selection and Combine Day tables selection allow customization of result tables display for multiple day studies

Figure 31. Calculation for each day displayed in single table when Combine Day Tables check box is selected; applicable only for multiple day studies

• Tabs: there are four tabs on the bottom half of the screen:

• Procedure Description, Indications, and Interpretations: these three tabs all allow for free text information input or selection from previously saved list. For details, see Commonly-used Information on page 39.

• Signatory Physician: includes signature line and input name, title, and affiliation of the responsible clinician (or can be selected from the list).


Commonly-used Information

The following lists can be customized to contain your own commonly-used text or ICD

codes: Procedure Description, Indications, Interpretations/Findings, Signatory Physician.

Adding, accessing, and removing data is similar for each list.

Figure 32. Procedure Description list

To save a procedural description, type the desired name (for example, 24hr pH

Ambulatory Study) in the list name field (next to Add from List). Then type the

description in the blank text field (below Add from List) and click Save.

To use an existing description, select it from the list and click 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 (cursor location).

To delete a saved description, choose it from the list and click Delete.

To add an ICD code, type in the code and descriptive title (for example, ICD: 530.1

[Erosive Esophagitis]) that you want to 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 (for

example, E. Esophagitis) in the list name field for the ICD code and click Save. Deleting

an ICD code is identical to deleting text.

Creating Reports

After entering the appropriate information in the Report Form, click Create. The Create

Report screen opens.

Note

When you select Save, all text in the text field will be saved under the

current list name. If the text field is blank, no text will be saved under

the name in the list name.


Figure 33. Create Report screen

1. In the upper right of the screen, set the document format type (Word, PDF, or

HTML).

2. Select the report template to choose the formatting and layout of the created report.

By default, more than one template is provided for Bravo studies to allow for table

layout options for multiple-day studies. However, user can create their own

templates. See Advanced Features on page 42.

3. Select the information to be included in the Report document:

• Summary Traces: includes a trace plot that visually summarizes the study.

• Summary Contour: includes a contour plot that visually summarizes the study.

• Diary: includes the Diary information entered in corresponding screen.

• Protocol: includes the probe placement and analysis setting of the protocol used in the study.


• Episodes: includes information about all pH episodes which are longer than certain duration (all, only those longer than 2 minutes, or only those longer than 5 minutes).

• Day-by-day: when selected, the analysis tables are calculated and included for each day separately (applicable only for studies longer than 24 hour).

• Parameter Explanations: includes definitions of parameters used in study.

• Contour Plot by Time, hours: displays the contour plot for the number of hours selected.

• Trace Plot by Time, hours: displays the trace plot for the number of hours selected.

• Print Selected Screen Images: includes snapshots chosen using Capture button when the study was reviewed.

4. To export the patient information and study report to the specified location, click

Send to HIS. For details, see HIS (Hospital Information System) on page 53.


Chapter 7

Advanced Features

This section describes certain advanced features of the software. Enabling these

functionalities require knowledge of internal functioning of the software, and can only be

accessed with the help of company’s Technical Support.

Custom Report TemplateReport templates allows specifying the layout and the format in which the report

document will be created. Reflux software provides the ability to choose the report

template to be used to create report documents (see Creating Reports on page 39). In

addition to using factory provided templates, you may create your own report templates to

be able to generate report in any customized layout.

Here is an example in which a user uses the functionality of creating custom template.

Figure 34 shows user interface for selecting report template. Figure 35 shows an example

of a custom report.

Figure 34. Selecting Report Template

Note

Contact Technical Support personnel if you are interested in using any

of the features described below!


Figure 35. Custom report example

Choosing Study and Report NamingSetup File Naming option allows specifying the information to be included in the name of

the study file (saved in Study Repository) or report document.

Figure 36. File Naming setup

Ability to Edit Analysis ProtocolIf enabled by Technical Support, you may edit an existing analysis protocols. The

functionality is not available otherwise.

Display and Report Customization The following attributes of Main Display and Report can be customized:

• pH and Impedance trace color and background color

• Impedance Contour Color map

• Report font size


Guide CustomizationInstructions shown on Guide and step sequences can be modified.

Enable Dual-day Analysis for 96-hour Bravo Studies The as-shipped version of the software presents day-by-day analysis for multiple day

studies. If requested, this functionality can be extended to present analysis for Day1+Day2

and Day3+Day4 periods as well.

Customizing Normal ValuesNormal values for all analysis parameters in the report are derived from specific

publications referenced in Analysis Parameter Explanations on page 49. The software

provides the ability to customize normal values to be used in the report. You may wish to

use different normal values for different study/patient scenario (for example, On and Off

medication). The software allows specifying a different set of normal values depending on

one or more of the following attributes:

• Medication status {On, Off, N/A}

• pH Sensor type {Bravo, Non-Bravo}

• Gender

• Age

Automatic Deletion of Repeated Button PressesThe patient may press a symptom button on the Recorder several times to record one

instance of a symptom. These repetitive symptom markers are typically manually

removed from the Diary form.

The software provides the ability to automatically remove multiple symptoms of the same

type if they are close to each other. This option is prompted when closing the Diary form.

Contact Technical Support to enable this feature.

Increase Font Size of Main DisplayFont size of the text visible on Main Display can be increased. This includes the text

corresponding to event names, time, pH/Z values, etc. The corresponding plots in the

report will also reflect the font size changes.

Remove User Folder Names from HTML ReportWhen the report is printed is HTML format, the HTML browser (for example, Internet

Explorer or Google Chrome) appends the name and path of the user’s report folder as the

footer. This information may need to be removed before the report is circulated outside the

hospital facility. Technical Support can help configure HTML browser setting so that this

information is not displayed in report printouts.


Chapter 8

Reflux Detection Algorithm

Reflux identified by impedance can be either pure liquid or a mixture of liquid and gas.

This section describes the impedance reflux detection algorithm.

Liquid Reflux/Swallow DetectionA liquid impedance reflux is detected automatically by the software using a three-tier

approach:

1. Detection of drop on each channel for the whole study.

2. Combination of these drops resulting in an episode.

3. Classification of episodes into Reflux, Swallow, or Unknown.

1. Detection of Drop

These steps are followed to detect an impedance signal drop on each channel (see

Figure 37).

• Impedance data (Z) is scanned from left to right. At each instance, baseline value Zbaseline is calculated by taking backward average of 10 second of non-gaseous data. Non-gaseous data is defined as those time instances for which Z <7000ohm. Exclusion of high impedance instances is done to make baseline calculation robust to gaseous artifacts.

• The effective Z value (Zeffective) at the instance is defined as 0.5 sec forward average of data. Zeffective (and not instantaneous value) is used for all further calculations so as to reduce the impact of noise. Further, only the non-gaseous data is used for the calculation of Zeffective.

• When the value is such that Zeffective / Zbaseline < Impedance Downward Threshold, it is marked as Tentry.

• Once a Tentry is found, the data is scanned further until Zeffective / Zbaseline > Impedance Return Threshold. This instance is marked as Texit_tentative.

• In some scenarios, an artifact may cause the drop to end prematurely (see Figure 39). End point detection is made robust by evaluating the stability of exit impedance value. Once Texit_tentative is identified, the software evaluates 5 sec of subsequent data. If the majority of the data points in this duration satisfies the criterion for exit, then Texit_tentative is marked as Texit. Additionally, if Texit_tentative is rejected, data is scanned further to identify actual Texit (see Figure 38). In the figure, note that the exit point is marked only after the impedance value satisfies the stability criterion.


• In the case when Texit is not found within 5 minutes of Tentry, the Tentry is rejected; no drop is marked for this scenario. Such scenario may occur when there is steep drift in impedance baseline.

• If the distal channel drops are smaller than 1.0 sec, then they are filtered out, and are not included in subsequent steps of reflux detection.

Figure 37. Impedance threshold controls

Figure 38. Detection of start and end of reflux


2. Combination of drops into Episodes

The next step is to analyze drops in all channels and combine them into individual

episodes.

• For each drop on the distal most channel (Z6), software evaluates rest of the channels to identify all neighboring drops. Neighboring drops are combined to form episodes (see Figure 39). All drops in other channels which are in the neighborhood time frame of a drop in Z6 channel are combined to form episodes.

Figure 39. Episodes

• The No. of distal channel for detection defines the minimum no. of distal channel drops that must be present in episode (default set to 2). If an episode does not have drop in all these channels, the episode is filtered out; it is not displayed to the user.

There are other filtering criterion applied in specific scenarios to improve the

results. This is beyond the scope of this discussion.

3. Classification of Episode into Reflux, Swallow, and Unknown

• If half or more pair of drops in an episode are retrograde in direction, then it is classified as Reflux. The direction is determined based on the entry time markers of the drops.

• If majority of pair of drops in episode are antegrade in direction, it is classified as Swallows. The drops corresponding to swallows are hidden from the user to reduce unimportant data markings on the display.


• The rest of the episodes are classified as Unknown. Unknowns are not labeled (or counted) on Main Display, but are displayed so that user can adjust boundaries and convert it into Reflux (if necessary) with minimal efforts.

Figure 40 provides examples of episodes.

Figure 40. Types of Episodes: Impedance Reflux (left image) and Unknown Episodes (right image)

Gas Reflux DetectionGas reflux is defined as a simultaneous increase in impedance in two consecutive sites

having an absolute value >7,000 ohms. There are several filtering criterion applied further

to improve accuracy of detection:

• Impedance signal rises that are smaller than certain time duration are rejected.

• Impedance rises in the proximity of swallows are rejected.

• If multiple impedance rises are close together, they are combined and treated as one

gas reflux. The marker indicating gas reflux is placed at the center of the combined

gas events.


Chapter 9

Analysis Parameter

Explanations

pH Based Parameters Definition

Period Durations Consists of the following information:

• Total Time: Total duration of study.

• Valid Time: Total Time minus period consisting of artifact, absent data and exclusion zone. Represents the duration of valid data in the study.

• Analysis Time: Total Time minus period consisting of artifact, absent data, exclusion zone and Meal period (if excluded from Protocol settings). Represents the duration for which the study is analyzed. If Analysis Time is less than 24 hours, certain analysis parameters are normalized and presented for 24 hour.

• Ignored Time: Duration of study that has not been accounted for analysis.

Valid Time and Ignored Time are displayed only when Extended Time Duration check box is selected in Setup Report & Analysis screen.

pH Analysis Thresholds This is user specified setting from Analysis Protocol. Episodes below this pH limit are potential refluxes.

Acid Reflux Analysis Provides various measures of acid reflux measured using pH sensor(s). A pH episode below Acid Threshold lasting for a period of Minimum Episode Duration is identified as reflux. Refluxes longer than Long Episode Criterion are identified as long refluxes. Factory default values set in Analysis Protocol is as follows: Acid Threshold= pH 4.0, Minimum Episode Duration = 2sec, Long Episode = greater than 5 min. This can be changed from the Analysis Protocol.

pH Normal Values for Bravo capsule studies taken from Shanin Ayazi et al., Normal Values, Concordance, Optimal Diagnostic Thresholds and Accuracy. Clinical Gastroenterology and Hepatology. 2009; 7:60-67

pH Normal values for catheter studies taken from Demeester et al., Twenty-four hour pH Monitoring of Distal Esophagus. American Journal of Gastroenterology 1974; 62 (4) 325-332


DeMeester Score Score to quantify acid exposure in Adults based on DeMeester TR. Ambulatory 24-H Esophageal pH Monitoring: Normal Values, Optimal Thresholds, Specificity, Sensitivity, and Reproducibility. Am J Gastroenterol.1992;87(9). Software does not use Analysis Protocol setting for this score. Following default settings are used: Acid Threshold= pH 4.0, Minimum Episode Duration = 2sec, Long Episode = greater than 5 min, Meal Period = Excluded, Analysis channel = channel located at 5cm above LES.

DeMeester Scoring Components

DeMeester score is based on the components provided in this table. For each component a score is calculated with regard to its normal mean value and standard deviation. The sum of these score results in DeMeester score.

DeMeester- Johnson Score Score to quantify acid exposure in adults based on Johnson LF, DeMeester TR. Twenty-four hour pH monitoring of the distal esophagus: A quantitative measure of gastroesophageal reflux. Am J Gastroentrol. 1974;62(4):325-332. Software does not use Analysis Protocol setting for this score. Default settings identified for DeMeester score above are used.

DeMeester- Johnson Scoring Components

Calculated similar to DeMeester Scoring Components. See explanation above.

Boix Ochoa Score Score to quantify acid exposure in infants/pediatrics based on Boix-Ochoa, DeMeester TR, Skinner DB. Pediatric Aspects of 24-hour pH Monitoring in Esophageal Disorders: Pathophysiology and Therapy. Ed. New York, NY: Raven Press; 1985. Software does not use Analysis Protocol setting for this score. Default settings identified for DeMeester score above are used. The analysis channel in Protocol can be located 1 to 5cm above LES.

Boix Ochoa Scoring Components

Calculated similar to DeMeester Scoring Components. See explanation above.

Vandenplas Infant Score Acid exposure parameters with Normal value from 509 healthy infants. Normal values derived from Y Vandenplas. Esophageal pH monitoring for Gastro-esophageal reflux in infants and children. Wiley; 1992. 109p.

Generic Score and Components

Generic score provides user with an option to calculate a score using user-defined Analysis Protocol settings (Analysis Channel, pH threshold, etc). The mean and standard deviation used are taken from DeMeester score publication.

Symptom Analysis Symptom analysis quantifies association of symptoms with esophageal acid exposure measured using pH sensor.

Symptom Index (SI) The ratio of number of symptoms related to pH acid reflux to the total number of symptoms, expressed as percentage.

Symptom Sensitivity Index (SSI)

The ratio of pH refluxes associated with symptoms to the total number of pH refluxes, expressed as percentage.



Symptom Associated Probability (SAP)

Probability that symptom and pH refluxes are not associated solely by chance. Calculation is performed as per Smout, et al. Symptom association analysis in ambulatory gastro-oesophageal reflux monitoring. Gut. 2005;54(12): 1810-1817. In a special scenario when the SAP score calculated may be due to random chance, the software sets SAP value to be 0. This is done as per the restriction formula defined in SAP publication.

SAP Table The table providing values for components used for calculation of SAP score. One combined table is provided for all the symptoms present in the study.

pH-Impedance Based Parameters

Definition

General Notes • Impedance refluxes are classified based on pH value at the location of impedance reflux. The refluxes are classified as Acidic (pH <4), Weakly Acidic (pH>4, pH<7) and Non-Acidic (pH>7). These thresholds can be changed from Analysis Protocol. For dual pH sensor study, the pH analysis channel is used for classification.

• Normal values for all the impedance based parameters, unless specified otherwise, are derived from Zerbib et al. Normal Values of Pharyngeal and Esophageal 24-Hour pH Impedance in Individuals on and off Therapy and Interobserver Reproducibility. Clinical Gastrology and Hepatology. 2013;11(4): 366-372.

Normalized Reflux Episode Activity

Count of reflux identified using impedance sensors. This only includes liquid and mixed refluxes. The values are normalized for 24-hour Analysis Time. Note that all studies with meal times excluded will have Analysis Time less than 24 hours; so for such studies reflux count shown in this table will be more than reflux count on software Main Display.

Reflux Episode Activity Count of actual number (raw data) of reflux identified using impedance sensors. This only includes liquid and mixed refluxes. The values are not normalized to 24 hours.

Refluxes Composition Count of actual number (raw data) of impedance refluxes classified into liquid, mixed and gas. Normal values derived from Zerbib F, et al. Normal values and day-to-day variability of 24-h ambulatory oesophageal impedance-pH monitoring in a Belgian-French cohort of healthy subjects. Alimentary pharmacology & therapeutics 2005;22(10):1011-1021.

Bolus Exposure Time (min) The time spent in impedance reflux measured at user-specified impedance channel, expressed in minutes. The 5th impedance channel (located 5cm above LES) is set as factory default for this measurement. This can be changed from the Analysis Protocol.

Bolus Exposure Time (%) The Bolus Exposure Time expressed as percentage. The percentage is calculated over the study Analysis Time.



Bolus Exposure Longest reflux (HH:MM)

The duration of reflux having longest Bolus Exposure Time.

Symptom Correlation to Reflux

This table quantifies association of symptoms with esophageal reflux exposure measured using impedance sensor.

Reflux Symptom Index The ratio of number of symptoms related to impedance reflux to the total number of symptoms, expressed as percentage.

Reflux Symptom Association Probability

Calculated similar to the pH based Symptom Association Probability parameter described above, except that the impedance refluxes are used.

Proximal Reflux Count Impedance reflux episodes that reach at least up to the proximal calculation channel are identified as proximal refluxes. The 2nd impedance channel is set as factory default for this measurement. This can be changed from the Analysis Protocol.

Proximal Reflux (%) Number of proximal refluxes, expressed as percentage of the total refluxes that occurred during the corresponding period (Upright, Supine, etc.).

Proximal Reflux Duration Duration of proximal refluxes.

Proximal Reflux Duration (%)

Duration of proximal reflux expressed as percentage of the study analysis duration of the corresponding period (Upright, Supine, etc.).

Reflux Extent Count Number of impedance refluxes of various classifications (acid, weakly, non-acid) that reach each of the impedance channels. Since, all of refluxes must reach both 5th and 6th impedance channel, the count is displayed only for rest of the channels.

Reflux Extent (%) Reflux Extent Count expressed as percentage. The percentage is calculated with total reflux of the corresponding acid classification.

Mean Nocturnal Baseline Impedance (MNBI)

Parameter calculated as average of impedance baseline in the distal most channel during the baseline periods in the study. User may insert Baseline period from using options under Tools menu. Only the baseline periods inserted during Supine durations are accounted for taking average.

If no baseline period is inserted, the whole Supine duration (excluding the periods of pH and Z refluxes) is used as baseline period. Thus, average impedance baseline during Supine durations is reported as MNBI.

pH-Impedance Based Parameters

Definition


Appendix

HIS (Hospital Information

System)

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

the HIS. Reflux Software supports interfacing with an HIS. This allows the import of

patient information from the HIS into Reflux Software and the export of the study report

from Reflux Software to the HIS.

Reflux Software accepts the patient information from an import file (.imp). It scans the

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

scheduled for procedure to the Patient Manager (accessible from the Diary > HIS Import

button).

Reflux Software exports the patient information when Send to HIS check box is selected

in the Create Report screen. The exported information consists of patient information

(.exp) and study report (.pdf), and is placed in the folder specified by Folders > HIS

Export. The figure below shows the data flow between the HIS and the Reflux Software.

Figure 41. Data workflow between the Reflux Software and the HIS


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

<his>

<patient>

<age>30</age>

<dob>1984-11-03</dob> //yyyy-mm-dd

<name>

<first>Krishna</first>

<last>Kumar</last>

<middle>Narayana</middle>

</name>

<gender>1</gender>

<id>21113A</id>

<height>1800</height> //units: mm

<weight>63502</weight> //units: gms

</patient>

<procedure>

<indications>Heartburn</indications>

</procedure>

</his>

Documents

Reflux Software 6.1 UG...The landmarks can be manually adjusted based on the patient’s anatomy. Optionally, landmark information can be extracted from a previous manometry study