Medtronic FGS-0656 Instructions for Use
Reflux Software
&
Reflux Reader
Version 6.1
User Guide
DOC-2869-05
COPYRIGHT & TRADEMARKS
Copyright ©2001–2021 Given Imaging Ltd. All rights reserved. Medtronic, Medtronic logo and Further,
Together are trademarks of Medtronic.
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.
TM*
Third party brands are trademarks of their respective owners.
Rx Only
Given Imaging Inc.
15 Hampshire Street,
Mansfield, MA 02048 USA
supportUS@givenimaging.com
Medtronic B.V.
Earl Bakkenstraat 10,
6422 PJ Heerlen, The Netherlands
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 .................................................................... 8
Setup Report & Analysis .................................................. 9
Event List ........................................................................ 10
Display Appearance ....................................................... 11
Protocol .......................................................................... 12
Setup Analysis ................................................................ 13
Reflux Software and Reflux Reader v6.1 i User Guide
Chapter 4: Using Main Windows and Controls ............. 15
Study Manager .................................................................... 15
Advanced Options (Filtered Searches) .......................... 16
Display Modes .............................................................. 18
Contour Mode ................................................................. 18
Line Trace Mode ............................................................ 19
The Profile Display ........................................................ 20
Main Display Toolbar .................................................... 22
Setting the Data Range ................................................ 22
The Analysis Screen Menus ......................................... 23
File Menu ........................................................................ 23
Setup Menu .................................................................... 24
Tools Menu ..................................................................... 24
Display Mode Options ................................................... 25
Navigation Bar ..................................................................... 25
Miscellaneous Controls .................................................. 26
Chapter 5: Reviewing a Study ........................................ 27
Features Helpful for Reviewing Studies............................... 27
Navigation ...................................................................... 27
Local Auto-range ............................................................ 28
Keyboard Shortcuts ........................................................ 29
Understanding and Editing Impedance Analysis Markers
29
Impedance 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 ii User Guide
Creating Reports.................................................................. 39
Chapter 7: Advanced Features ....................................... 42
Custom Report Template .............................................. 42
Choosing Study and Report Naming ............................ 43
Ability to Edit Analysis Protocol .................................... 43
Display and Report Customization ............................... 43
Guide Customization .................................................... 44
Enable 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.......................... 45
Liquid 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 iii User Guide
Chapter 1
Introduction
Welcome to Reflux Software
Reflux Software v6.1 and Reflux Reader v6.1 provide tools to efficiently analyze
information obtained from the ambulatory reflux monitoring recorders (BravoTM and
Digitrapper
• 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
Product Intent
Audience
This user guide is intended for the trained medical personnel. All users should have basic
familiarity with Microsoft Windows.
TM
). This user guide describes the features and use of:
recorder or automated detection)
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.
Note
Any pH studies recorded with capsule–pH calibration not required
can only be uploaded and reviewed with this version (v6.1) of Reflux
Software.
Reflux Software and Reflux Reader v6.1 1 User Guide
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)
Reflux Software and Reflux Reader v6.1 2 User Guide
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
main display.
Setup > Language
from the Reflux Software
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
Reflux Software and Reflux Reader v6.1 3 User Guide
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
Reflux Software and Reflux Reader v6.1 4 User Guide
Uploading a Study
֠
A 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.
Note
You cannot upload data with the Reflux Reader.
Entering Diary Information
When the study data has been uploaded, the
appears.
Edit Information & Diary
screen
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
2. Complete the study information (date, physician names, etc.).
Reflux Software and Reflux Reader v6.1 5 User Guide
HIS (Hospital Information System)
on page 53).
3. Select the protocol corresponding to the probe being used. Click
to
Setup Analysis
screen to view the analysis setting being used. To use different
Setup
to navigate
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 Study
The 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
Using Main Windows and Controls
on page 15.
Completing Setup
on page 8 and
Figure 4. Study displayed in Main Display
Reflux Software and Reflux Reader v6.1 6 User Guide
Creating the Report
A 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
you have reviewed the report settings and made any necessary changes, click
report is then generated in the specified format (Microsoft Word, PDF, or HTML).
in the
Setup
menu (see
Setup Report & Analysis
on page 9). When
OK
. The
Figure 5. Report screen
Saving the Study
To save patient analysis data at any time during the analysis process, select
The study is saved in the folder specified through
Setup
menu.
Folders > Study Repository
Reflux Software and Reflux Reader v6.1 7 User Guide
File > Save
under the
.
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 pHZ analysis and Reflux Reader needs. You can access these settings through the
menu.
We recommend that you configure the applications before starting to use them. However,
you can always change settings later.
Setup Menu
Use the Setup menu to customize Reflux Software settings, including analysis and report
preferences.
Option Function
Report Parameters Opens the
Load Settings Whenever the application is opened, the settings named as
Save Settings Saves currently selected settings (preferences), such as
Site Info Opens the
Units Opens the
Event List Opens the
analysis parameters to be included in the report. For details,
see
Default are used. You can select other previously-saved
settings in the
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
impedance & pH ranges, view configuration, and report
settings. Settings can be saved as Default or any user-defined
name.
information about the clinical site (to be included in the report).
units of measurement (height and weight).
events available for selection in the diary. For details, see
Event List
Setup Report & Analysis
Setup Report & Analysis
Load Settings
Save Settings
Setup Site Information
Units
Event List
on page 10.
screen.
screen to change formats (date and time) and
screen to customize symptoms and
screen to select the
on page 9.
screen. The loaded settings are
screen to input
Setup
Reflux Software and Reflux Reader v6.1 8 User Guide
Option Function
Display Appearance Opens the
display mode and data range values. For details, see
Appearance
Protocol Opens the
protocols, including probe type selection, probe channel
placement specifics, and analysis settings. For details, see
Protocol
Language Allows selection of the user interface language
Folders Opens the
Repository, Report, HIS Import, and HIS Export folders. Study
Repository is the folder where studies are saved.
Display Appearance
on page 11.
Protocol
on page 12.
Folders
screen to create and configure study
screen to set the location of the Study
screen to set the default
Display
Setup Report & Analysis
Use 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
Reflux Software and Reflux Reader v6.1 9 User Guide
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.
Drug
or
Med
Medication events may be displayed as either
events are displayed as
An option is included for
Med
Prone
.)
position to be included in the analysis and report for
. (In this guide, medication
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.
Reflux Software and Reflux Reader v6.1 10 User Guide
To apply the changes to the current study and save them as the future default, click
Default
.
Figure 7. Setup Event List
Set As
Display Appearance
Use 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.
Reflux Software and Reflux Reader v6.1 11 User Guide
֠
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
Protocol
The 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.
Note
Changing catheter placement from 5 cm to any other location removes
the standard scores (such as DeMeester Score) from the final report.
4. To change analysis parameters, click
Next
. The
Setup Analysis
screen appears.
Reflux Software and Reflux Reader v6.1 12 User Guide
5. Click OK to complete creating a new protocol. Click OK to close the
Analysis
screen.
Setup
Figure 9. Setup Protocol
Setup Analysis
Use 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
Acid threshold pH boundary for acid reflux (typically pH 4.0).
Minimum pH episode
duration
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
Analyze pH episodes as
reflux in impedance
symptom (acid reflux)
analysis
impedance refluxes.
The minimum pH duration in seconds that defines an acid
reflux.
within which a symptom will be associated with the episode.
Enable or use of pH episodes in the impedance symptom
analysis. If enabled, these episodes are classified as being
acidic.
Reflux Software and Reflux Reader v6.1 13 User Guide
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