Bravo
TM
Reflux Testing System
User Guide
DOC-4009-04
Table of Contents
Table of Contents
Introduction......................................................................................................... 1
Description ............................................................................................. 1
Two Capsule Types ................................................................................ 1
Indications for Use ................................................................................. 1
Contraindications ................................................................................... 2
Warnings and Precautions ...................................................................... 2
Intended Use Environment ..................................................................... 3
Storage ................................................................................................... 3
Electromagnetic Compatibility .............................................................. 3
Patient Information (Benefits and Risks) ............................................... 4
System Components for Capsule–pH Calibration Not Required ........... 5
System Components for Capsule–pH Calibration Required .................. 6
System Workflow .................................................................................. 8
Bravo pH Recorder ............................................................................................. 9
Description ............................................................................................ 9
Backlight ................................................................................................ 9
Patient Buttons ..................................................................................... 10
Clinician Buttons and Menus ............................................................... 11
Status LED ........................................................................................... 12
General Guidelines ............................................................................... 12
Charging the Recorder ......................................................................... 12
Turning the Recorder On and Off ........................................................ 13
Setting the Date and Time .................................................................... 13
Choosing Study Settings ...................................................................... 14
Performing a Bravo pH Study without pH Calibration .................................... 16
Preparing the Delivery Device ............................................................. 16
Setting up the Vacuum ......................................................................... 18
Starting Recording ............................................................................... 19
Placing the Capsule .............................................................................. 20
Stopping a pH Study ............................................................................ 25
Performing a Bravo pH Study with pH Calibration ......................................... 26
Calibrating Capsules ............................................................................ 26
Setting up the Vacuum ......................................................................... 32
Starting Recording ............................................................................... 33
Placing the Capsule .............................................................................. 34
Stopping a pH Study ............................................................................ 38
Reviewing Instructions with Patients ............................................................... 39
Bravo Reflux Testing System i User Guide
Table of Contents
Uploading pH Data ........................................................................................... 41
Recorder Maintenance ...................................................................................... 42
Safety and Technical Checks ............................................................... 42
Cleaning the Recorder .......................................................................... 42
Cleaning the Case and Strap ................................................................ 42
Servicing the Battery ............................................................................ 42
Troubleshooting ................................................................................................ 43
Delivery Device Disassembly Procedure ............................................. 43
Recorder Troubleshooting .................................................................... 45
Appendix A: Technical Data ............................................................................ 48
Bravo Recorder .................................................................................... 48
Recorder Servicing ............................................................................... 49
USB Cable ........................................................................................... 49
Charger ................................................................................................ 49
Battery ................................................................................................. 49
Essential Performance of Bravo Recorder ........................................... 49
Electromagnetic Compatibility Declaration (EN / IEC 60601-1-2) .... 50
Bravo Capsule Specifications .............................................................. 54
Bravo Delivery Device Specifications ................................................. 54
Appendix B: Symbols on Package Labeling .................................................... 55
Bravo Reflux Testing System ii User Guide
Introduction
Description
The BravoTM Reflux Testing System is intended to be used for gastroesophageal
pH measurement and monitoring of gastric reflux:
• First, the Bravo recorder (an ambulatory, programmable data recorder) and the
delivery device containing the Bravo capsule are prepared.
• Following either endoscopy or manometry, a Bravo capsule is positioned and
attached in the patient’s esophagus using the delivery device.
• The data is collected by the capsule and transmitted to the recorder for the duration
of the study.
• The data is then uploaded from the recorder to the software application on the PC or
workstation. The software application is used to record, store, view, and analyze
gastroesophageal pH data, enabling physicians to interpret study results.
Two Capsule Types
There are two types of Bravo capsules that can be used with the Bravo Reflux Testing
System:
• capsule–pH calibration not required: this capsule does not require any pH
calibration. This capsule does not have a soaker bulb. It works only with the colored
recorder (not the white recorder or the black receiver). The data it collects can only
be viewed and analyzed with Reflux software version 6.1 or later.
• capsule–pH calibration required: this capsule requires pH calibration. This capsule
has an attached soaker bulb that needs to be removed before pH calibration. The
capsule works with all versions of the recorder. The data it collects can be viewed
and analyzed with AccuView 5.2 or Reflux software version 6.0 or higher.
Indications for Use
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.
Bravo Reflux Testing System 1 User Guide
Contraindications
!
Patients with bleeding diathesis, strictures, severe esophagitis, varices, obstructions,
pacemakers or implantable cardiac defibrillators are contraindicated.
Warning
Patients are restricted from undergoing an MRI study for 30 days from
the start of a pH study. The Bravo Reflux Testing System is not
compatible for use in an MRI magnetic field. Use of the Bravo Reflux
Testing System in an MRI magnetic field will result in damage to the
system and possible patient injury.
Warnings and Precautions
• Bravo pH capsule with delivery device: Potential complications include, but are
not limited to:
• aspiration of the capsule if inadvertently pulled back up into the upper
esophagus by the delivery device. There is a possibility that this may occur in a
procedure in which the capsule did not attach to the esophageal mucosa.
• tears or perforations in the mucosal and submucosal layers of the esophagus
causing bleeding and requiring possible medical intervention.
• gastrointestinal endoscopy: Potential complications include, but are not
limited to: perforation, hemorrhage, aspiration, fever, infection, hypertension,
respiratory arrest, and cardiac arrhythmia or arrest.
• nasal intubation: Potential complications include, but are not limited to: sore
throat, discomfort, and nasopharyngeal damage resulting in bleeding and soft
tissue damage.
• Bravo pH capsule: Potential complications include, but are not limited to:
• pain or discomfort (including chest pain) associated with the capsule, failure of
the capsule to detach from the esophagus, or failure to attach the capsule to the
esophagus, which may necessitate intervention with upper endoscopy.
• premature detachment of the capsule.
• The safety and efficacy of the Bravo pH capsule with delivery device has not been
established for pediatric use on patients below the age of 4.
• The Bravo pH capsule with delivery device is a single-use, disposable device. Reuse
or any other misuse of a Bravo pH capsule with delivery device (such as sharp
bending or kinking) results in an increased potential for damage to the delivery
device and capsule, and possible patient injury.
• Prior to use, all equipment for the pH study should be examined carefully to verify
proper function.
• Unauthorized maintenance by inadequately trained personnel would result in an
unacceptable risk (e.g., excessive temperatures, fire, or explosion).
Bravo Reflux Testing System 2 User Guide
• A thorough understanding of the technical principles, clinical applications and risks
associated with the Bravo recorder is necessary before using this product. Read the
entire manual before using the system for the first time.
• No modification of this equipment is allowed.
• Patients are restricted from undergoing an MRI study within 30 days of the pH
study.
• The Bravo capsule contains a trocar needle that is made of stainless steel. Use
caution in patients with known sensitivities or allergies to the metals that are
contained including chromium, nickel, copper, cobalt, and iron. Tests last from 48 to
96 hours.
• Prior to the pH study, the patient should not eat or drink for a minimum of 6 hours.
• If excretion of the Bravo pH capsule from the patient has not been positively
verified, and the patient develops unexplained postprocedure abdominal pain,
vomiting, or other symptoms of obstruction, the patient should contact the physician
for evaluation and possible abdominal X-ray.
• Undergoing an MRI while the Bravo pH capsule is inside the patient’s body may
result in serious damage to the patient’s intestinal tract or abdominal cavity. If the
patient did not positively verify the excretion of any Bravo pH capsule, the patient
should contact the physician for evaluation and possible abdominal X-ray before
undergoing an MRI examination.
Intended Use Environment
Hospital, clinic, gastroenterology center and home environment.
Storage
Store all components in a controlled room temperature environment:
• capsules at 15–45 °C (59–113 °F)
• recorder at 0–40 °C (32–104 °F)
Electromagnetic Compatibility
Electrical equipment for medical use requires special electromagnetic compatibility
(EMC) precautions and should be installed and serviced according to the documentation
of device. Portable and mobile communication equipment can affect electrical equipment
for medical use. For additional information on electromagnetic compatibility, see
Electromagnetic Compatibility Declaration (EN / IEC 60601-1-2) on page 50.
Bravo Reflux Testing System 3 User Guide
Patient Information (Benefits and Risks)
Benefits
Bravo Reflux Testing System provides a more tolerable and convenient way to
evaluate your reflux symptoms when compared to catheter-based pH monitoring
systems.
The capsule is temporarily attached to the wall of your esophagus. The capsule
transmits pH information wirelessly to a small recorder that you wear. Data can be
transmitted approximately 2 meters (6 feet), which means that you can take the
recorder off to shower and sleep without interrupting the test.
You can engage in your usual activities during the test, which can provide your
doctor with a more accurate picture of your acid exposure compared to data collected
using catheter-based systems.
Risks
The Bravo pH test is not for everyone. If you have bleeding diathesis, strictures,
severe esophagitis, varices, obstructions, a pacemaker, or an implantable cardiac
defibrillator, you should not undergo a Bravo pH test.
Potential complications include, but are not limited to, the following events:
• perforation
• premature detachment of the pH capsule
• failure of the pH capsule to detach from the esophagus within several days after
placement or discomfort associated with the pH capsule, requiring endoscopic
removal
• tears in the mucosal and submucosal layers of the esophagus, causing bleeding
and requiring possible medical intervention
Potential complications associated with gastrointestinal endoscopy include:
• perforation or hemorrhage
• aspiration
• fever or infection
• hypertension
• respiratory arrest
• cardiac arrhythmia or arrest
Note
All pH testing procedures carry some risks. This information should not
be used as a substitute for talking with your doctor about diagnosis and
treatment.
Bravo Reflux Testing System 4 User Guide
System Components for Capsule–pH Calibration Not Required
2
1
3
4
5
6
7
The Bravo Reflux Testing System consists of the following items:
1 Bravo pH recorder (referred to as recorder in this user guide)
2 case and shoulder strap
3 USB cable
4 charger
5 Reflux software (version 6.1 or higher), delivered separately either on media or
pre-installed on a bundled PC workstation (referred to as PC in this user guide)
6 Bravo pH capsule with delivery device (referred to as capsule in this user guide)
7 vacuum pump (the legal manufacturer of this item is: Medela AG, Baar,
Switzerland)
Bravo Reflux Testing System 5 User Guide
System Components for Capsule–pH Calibration Required
The Bravo Reflux Testing System consists of the following items:
1 Bravo pH recorder (referred to as recorder in this user guide)
2 case and shoulder strap
3 USB cable
4 charger
5 Reflux software, delivered separately either on media or pre-installed on a
bundled PC workstation (referred to as PC in this user guide)
6 Bravo pH capsule with delivery device (referred to as capsule in this user guide)
7 vacuum pump (the legal manufacturer of this item is: Medela AG, Baar,
Switzerland)
8 pH 1.07 and pH 7.01 calibration buffer solutions
9 calibration stand
10 sterile water (to be supplied by the user)
Bravo Reflux Testing System 6 User Guide
2
1
3
4
5
6
7
8
9
Bravo Reflux Testing System 7 User Guide
System Workflow
When using the Bravo Reflux Testing System, you follow this general workflow:
1 Setting up the recorder: this includes charging the battery, setting the date and
time, and defining the default settings for studies. You only need to do it once
(though values can be changed later as needed). See Setting the Date and Time on
page 13.
2 Performing a procedure: this includes preparing the delivery device and placing
the capsule in the patient. If you are using the
see Performing a Bravo pH Study without pH Calibration on page 16. If you are
using the capsule–pH calibration required, see Performing a Bravo pH Study with
pH Calibration on page 26.
capsule–pH calibration not required,
3 Instructing the patient: this includes reviewing information about the study with
the patient, such as instructions on using the recorder and filling out the patient
diary. See Performing a Bravo pH Study with pH Calibration on page 26.
4 Data upload: this includes transferring the study data from the recorder to the PC
for analysis in the application software at the end of the study duration. See
Uploading pH Data on page 41.
You must also become familiar with the basic workings of the recorder, including normal
maintenance functions such as recharging and cleaning. See Bravo pH Recorder on page 9
and Recorder Maintenance on page 42.
Bravo Reflux Testing System 8 User Guide
Bravo pH Recorder
on/off button
LCD screen
symptom
buttons
recorder
status LED
Figure 1. Bravo recorder, front
view.
case
Description
The Bravo pH recorder is
lightweight and compact. It
fits into a case that comes
with a strap and a belt clip.
Patients wear the recorder
(over the shoulder or
attached to a belt)
throughout the study period.
There are two different
models of the recorder. The
white recorder supports
capsules that require
calibration. The colored
recorder supports capsules
that do not require
calibration. Both recorder
models have similar settings and the same patient user interface.
Backlight
The recorder has a backlit LCD screen and a row of symptom buttons. The backlight turns
off automatically (select the backlight duration in Preferences). Pressing any key turns on
the backlight. Only when the backlight is on can any of the recorder functions be used (for
example, menu access for recorder setup, or symptom buttons for patient use).
Bravo Reflux Testing System 9 User Guide
Patient Buttons
3
meal
supine
heartburn*
regurgitation*
chest pain*
* The default values of these buttons can be
set in the software application.
regurgitation icon
Figure 3. Regurgitation symptom icon as it
appears on the recorder screen
before and after pressing the
button.
after pressing button
When the recorder is placed in the case and is in record mode (that is, during a study), the
on/off button and USB port are covered. The patient can use the three symptom buttons
(Chest Pain, Regurgitation, and Heartburn) and the two event buttons (Meals and Supine)
to record events during a study (see Figure 2).
Figure 2. Symptom and event buttons.
During a study, the patient pushes
any button to turn on the backlight.
Once the backlight is on, pressing
a symptom button causes a beep to
occur, the button’s LED to light up
briefly, and its icon is inverted
briefly on the screen (see
Figure 3). If the button is one of
the event buttons, a beep occurs
and the button’s LED starts
blinking, indicating the event’s
start time. The blinking continues until the patient presses the button again when the event
ends. (That is, the patient presses any button to first turn on the backlight, and then presses
the event button to signal the end of the event.)
Note
Meal and Supine buttons can be used for patient input during the
study.
Bravo Reflux Testing System 10 User Guide
Clinician Buttons and Menus
You, the clinicians, have access to the menu to program the recorder for a study. The main
menu appears after the welcome screen when the recorder is turned on.
While in the menu, you use the symptom buttons to navigate. The buttons have different
meanings depending on the screen. For example, you may be prompted to press
Skip, Cancel, etc. The recorder screen shows an arrow pointing to the appropriate button:
Escape/back. Goes back (returns to previous level in the menu).
For the purpose of this document, ESC is used to indicate either escape/back
button.
Escape/back: same functionality as the above.
In addition, it is also used to set the date and time.
For the purpose of this document, ESC is used to indicate either escape/back
button.
Scroll. Moves to the next option for a setting.
Enter/next. Saves the settings on that screen and returns to the previous location
in the menu.
For the purpose of this document, Enter is used to indicate either Enter/next
button.
Enter/next: same functionality as the above.
For the purpose of this document, Enter is used to indicate either Enter/next
button.
Yes, No,
Note
Instructions are provided using the name of the function (such as Yes).
The corresponding physical button for the action varies, so always refer
to the recorder screen to see which buttons are used.
The Settings menu is not accessible once recording has started.
Bravo Reflux Testing System 11 User Guide
Status LED
There is a small LED below the symptom buttons. The LED
indicates the capsule transmission status and the state of the
recorder by the color and duration or frequency of the flash.
LED Status Meaning
off (no light)
blinking blue
blinking red
steady red
steady green
steady green
steady orange
Not recording any capsule transmissions. Data
from previous study has been uploaded.
Receiving transmission from the paired capsule
(recording).
A transmission error has occurred.
Recorder is upgrading or has not turned on
correctly.
Study completed but data has not yet been
uploaded to the software application.
Data is being uploaded.
(Applicable to capsule–pH calibration
required, only) User pressed OK after
Calibration completed message was
displayed.
General Guidelines
When working with the recorder:
• All values in Settings (for example, study duration, number of capsules) and
Preferences (for example, date and time format and interface language) stay in
effect for all studies until you change them.
• Fully recharge the battery before each study (see Charging the Recorder on
page 12).
• Clean the recorder after each study (see Cleaning the Recorder on page 42).
Charging the Recorder
The recorder is delivered with the battery fully discharged. It must be recharged before
using. A fully discharged recorder battery may take up to 7 hours to charge.
• Connect the recorder to the charger and plug it into an electrical outlet, or
• Connect the recorder to a USB cable and connect it to your PC. Do not use this
method for charging more than one recorder simultaneously.
Bravo Reflux Testing System 12 User Guide
Turning the Recorder On and Off
Set Date/Time
DD-MM-YY
hh:mm AM/PM
►
1. Press and hold the on/off button (see Description on page 9) for 5 seconds until the
recorder screen turns on.
The recorder automatically performs an internal diagnostic check, which includes
checking the batteries and verifying the time and date.
• The recorder screen displays a brief welcome message showing the software and
hardware versions.
• If the date or time is not available, the recorder automatically displays the screen
to set the date and time.
• If the battery has reached the end of its life, the recorder displays: Recorder
battery needs replacement. Contact customer support.
• If the main battery is low, the recorder displays: Charge battery.
• If date, time, and battery condition is good, the main menu is displayed!
Note
The cursor’s default position shows the next logical step in your
workflow.
2. To turn off the recorder, press and hold the on/off button for 2–3 seconds until Turn
OFF the Recorder?
appears on the recorder screen.
Note
The backlight remains on during the Settings process (and Calibration
process, if applicable).
When recording or the main screen is displayed, the backlight turns off
after the predefined time (default 30 seconds; see Choosing Study
Settings on page 14). Press any key to turn it back on. If you are not
sure if the recorder is turned on, press the on/off button once.
Setting the Date and Time
You must set the date and time the first time you turn on the recorder or if the battery has
fully discharged. Once the date and time are set (and as long as the battery does not fully
discharge), the recorder maintains the correct date and time, even when it is turned off.
However, if the battery was fully discharged before turning the recorder on, the screen will
automatically display the
To set the date and time:
1. The first part of the date (for example, the day field) is
highlighted. Use below the icon displayed on
the screen and ( on the screen) to change it to
the correct date. Press ( on the screen) to move to the next field.
Bravo Reflux Testing System 13 User Guide
Set Date/Time screen.
2. Repeat this process for the rest of the date (for example, month and year).
pH Capsules #1
Study Duration: 48hr
Preferences:
►
3. Repeat this process to set the time. When you are done, press
returned to the main menu.
If time and date are correct, press
ESC and return to the main menu.
Choosing Study Settings
1. From the main screen, select Settings. This screen
appears:
2. Set the number of capsules as follows:
a. With the cursor on pH Capsules #1, press
Enter.
b. Use to select the number of capsules.
c. Press
3 Set the study duration as follows:
a. With the cursor on Study Duration, press Enter.
b. Use to select the study duration (24, 48, or 96 hours).
c. Press
Enter. You move on to the next setting: Study Duration.
Enter. You move on to the first screen of the next setting: Show pH
Value
.
Note
At any time you may select Settings from the Main screen and
access Preferences to review and set the parameters.
Enter . You are
4. The
Bravo Reflux Testing System 14 User Guide
Preferences screen allows you to define setting that affect all studies.
• Show pH Value: If Yes, the current pH value appears on the recorder screen
during studies. If No, pH values are only displayed for the first 30 minutes of a
study. The factory default is
• Button Beep: If
Yes, the recorder beeps when the patient presses a symptom
No.
button. The factory default is Yes.
• Capsule LED Blink: If
Yes, the recorder capsule LED blinks when the capsule
signals are received. The factory default is Yes.
• Set Date/Time: Once set, the recorder maintains the correct date and time. You
should only have to change this again if there is a time change (for example,
going on or off of Daylight Savings), or if the recorder battery is allowed to fully
discharge.
• Date Format: You can set the date format to MM-DD-YY or DD-MM-YY (factory
default).
• Time Format: You can set the time format to
(military)
(factory default).
12-hour (AM/PM) or 24-hour
• Language: Select the language for the recorder interface. The choices are
English (factory default), Danish, Dutch, Finnish, French, German, Italian,
Norwegian, Portuguese, Spanish, and Swedish.
• Backlight Duration: Set the time that the recorder screen backlight stays on
after a button is pressed. The choices are 15, 30 (factory default), 45, or 60
seconds.
5. To return one level up in the menu tree, press
Note
Once you have set preferences, you do not need to reset them
unless:
• you want to change something, or
• the recorder battery is fully discharged.
ESC.
Bravo Reflux Testing System 15 User Guide
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