Given Imaging Bravo User Manual
Bravo
®
pH Monitoring System
User Guide
DOC-2033-07
March 2016
Copyright & Trademarks
Rx Only
Copyright © 2001–2016 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.
FCC Compliance Statement
This device complies with Part 15 of the FCC. Operation is subject to the following two
conditions:
1 This device may not cause harmful interference.
2 This device must accept any interference received, including interference that
may cause undesired operation.
Given Imaging
15 Hampshire Street,
Mansfield, MA 02048 USA
supportUS@givenimaging.com
Medtronic B.V.
Earl Bakkenstraat 10,
6422 PJ Heerlen, The Netherlands
Table of Contents
Table of Contents
Introduction......................................................................................................... 1
Description ............................................................................................. 1
Indications for Use ................................................................................. 1
Contraindications ................................................................................... 1
Warnings and Precautions ...................................................................... 2
Storage ................................................................................................... 3
Electromagnetic Compatibility .............................................................. 3
Patient Information (Benefits and Risks) ............................................... 4
System Components ............................................................................... 5
System Workflow .................................................................................. 6
Bravo pH Recorder ............................................................................................. 7
Description ............................................................................................ 7
Backlight ................................................................................................ 7
Patient Buttons ....................................................................................... 7
Clinician Buttons and Menus ................................................................. 8
Status LED ............................................................................................. 9
General Guidelines ................................................................................. 9
Charging the Recorder ......................................................................... 10
Turning the Recorder On and Off ........................................................ 10
Setting the Date and Time .................................................................... 11
Choosing Study Settings ...................................................................... 11
Calibrating Capsules ......................................................................................... 13
Existing Data ........................................................................................ 13
Starting Calibration .............................................................................. 13
Performing a Bravo pH Study .......................................................................... 19
Setting up the Vacuum ......................................................................... 19
Starting Recording ............................................................................... 20
Placing the Capsule .............................................................................. 21
Stopping a pH Study ............................................................................ 25
Reviewing Instructions with Patients ................................................... 26
Uploading pH Data ........................................................................................... 28
Recorder Maintenance ...................................................................................... 29
Safety and Technical Checks ............................................................... 29
Cleaning the Recorder .......................................................................... 29
Cleaning the Case and Strap ................................................................ 29
Servicing the Battery ............................................................................ 29
Bravo pH Monitoring System i User Guide
Table of Contents
Troubleshooting ................................................................................................ 30
Delivery Device Disassembly Procedure ............................................. 30
Recorder Troubleshooting .................................................................... 32
Appendix A: Technical Data ............................................................................ 35
Bravo pH Recorder .............................................................................. 35
Recorder Servicing ............................................................................... 35
USB Cable ........................................................................................... 36
Charger ................................................................................................ 36
Battery ................................................................................................. 36
FCC Compliance Statement ................................................................. 36
Declaration of Conformity ................................................................... 36
Essential Performance of Bravo Recorder ........................................... 36
Electromagnetic Compatibility Declaration (EN / IEC 60601-1-2) .... 37
Bravo pH Capsule Specifications ........................................................ 41
Bravo pH Delivery Device Specifications ........................................... 41
Appendix B: Symbols on Package Labeling .................................................... 42
Bravo pH Monitoring System ii User Guide
Introduction
!
Description
The Bravo® pH Monitoring System is intended to be used for gastroesophageal
pH measurement and monitoring of gastric reflux:
•
First, a Bravo pH capsule is calibrated and the Bravo pH recorder (an ambulatory,
programmable data recorder) is prepared.
•
Using the delivery device, the capsule is positioned and attached in the patient’s
esophagus, following either endoscopy or manometry.
•
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.
Indications for Use
The Bravo pH 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 pH capsule can be attached following either endoscopy or manometry. The
AccuView and Reflux software applications are intended to record, store, view, and
analyze gastroesophageal pH data.
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 pH Monitoring System is not
compatible for use in an MRI magnetic field. Use of the Bravo pH
Monitoring System in an MRI magnetic field will result in damage to the
system and possible patient injury.
Bravo pH Monitoring System 1 User Guide
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:
• discomfort associated with the capsule, or failure to detach from the esophagus
within several days after placement, either of which may necessitate endoscopic
removal.
• 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).
•
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. The Bravo pH test
lasts from 48 to 96 hours.
Br
avo pH Monitoring System 2 User Guide
•
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.
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 37.
Bravo pH Monitoring System 3 User Guide
Patient Information (Benefits and Risks)
֠
Benefits
Bravo pH monitoring 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. Additionally, because the
capsule contains a small magnet, you should not have an MRI study within 30 days
of undergoing the 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 pH Monitoring System 4 User Guide
System Components
2
1
3
4
5
6
7
8
9
The Bravo pH Monitoring 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
AccuView or 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
8
pH 1.07 and pH 7.01 calibration buffer solutions
9
calibration stand
10
sterile water (to be supplied by the user)
Bravo pH Monitoring System 5 User Guide
System Workflow
֠
When using the Bravo pH Monitoring System, you follow this general workflow:
1
2
3
4
5
6
Charging the battery: you can charge the recorder by connecting the supplied
charger to an electrical outlet or by connecting the supplied USB cable to your PC.
Recorder setup: this includes 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 11.
Calibration: this includes making sure that the capsule is correctly reading the pH
levels. You do this for every study. See Calibrating Capsules on page 13.
Capsule placement: this includes performing the procedure of positioning and
attaching the capsule in the patient. See Placing the Capsule on page 21.
Patient instructions: this includes reviewing information about the study with the
patient, such as instructions on using the recorder and filling out the patient diary.
See Reviewing Instructions with Patients on page 26.
Study duration: this includes the patient wearing the recorder for the study
duration.
7
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 7
and Recorder Maintenance on page 29.
Data upload: this includes transferring the study data from the recorder to the PC
for analysis in the application software. See Uploading pH Data on page 28.
Note
The recorder always defaults to the expected action in the workflow. For
example, if the calibration process has been completed successfully, the
recorder menu cursor automatically points to Start Study. This simplifies the
process and reduces the risk of errors. However, you can manually select
another menu option at any time.
Bravo pH Monitoring System 6 User Guide
Bravo pH Recorder
on/off button
LCD screen
symptom
buttons
recorder
status LED
Figure 1. Bravo recorder, front
case
3
meal
supine
heartburn*
regurgitation*
chest pain*
* The default values of these buttons can be
set in the software application.
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.
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
any of the recorder functions be used (for example, menu access for recorder setup, or
symptom buttons for patient use).
). Pressing any key turns on the backlight. Only when the backlight is on can
Patient Buttons
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.
Bravo pH Monitoring System 7 User Guide
During a study, the patient pushes
֠
regurgitation icon
Figure 3. Regurgitation symptom icon as it
appears on the recorder screen
before and after pressing the
button.
after pressing button
Calibrate
Start Study
Settings
►
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.
When the recorder’s PC Software preference is set to RAPID pH,
the Meal and Supine features are not supported. These buttons are
located on the left and the right of the symptom buttons and are
used only to navigate while setting up a study. Once a study
recording has begun, the Meal and Supine buttons are disabled for
patient use.
For details about selecting the software application, see Choosing
Study Settings on page 11.
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
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.
Yes, No, Skip, Cancel
, etc. The recorder screen
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
Bravo pH Monitoring System 8 User Guide
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.
Note
Instructions are provided using the name of the function (such as Yes).
Button positions change, so always refer to the recorder screen to see
which buttons are used.
Once a recording has started during a study, the menu is no longer
accessible.
Status LED
There is a small LED below the symptom buttons. The LED
indicates the status of recorder by the color and duration or
frequency of the flash.
LED Status Meaning
off (no light)
blinking blue
blinking or steady red
steady green
blinking 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.
Study completed but data has not yet been
uploaded to the software application.
Data is being uploaded.
User has pressed OK after
completed
message appeared on the screen.
calibration is
General Guidelines
When working with the recorder:
•
All values in
Preferences
Settings
(for example, date and time format and interface language) stay in
effect for all studies until you change them.
Bravo pH Monitoring System 9 User Guide
(for example, study duration, number of capsules) and
•
֠
֠
Fully recharge the battery before each study (see Charging the Recorder on
page 10).
•
Clean the recorder after each study (see Cleaning the Recorder on page 29).
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.
Turning the Recorder On and Off
1. Press and hold the on/off button (see Description on page 7) 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 battery is sufficiently charged and the time and date are available, the main
menu is displayed.
• If the date or time is not available, the recorder automatically displays the screen
to set the date and time.
• If the main battery is low, the recorder displays:
Note
The cursor’s default position shows the next logical step in your
workflow. For example, if you have completed calibration, the cursor
appears at Start Study. (You can move the cursor to select something
else.)
Charge battery!
2. To turn off the recorder, press and hold the on/off button for 2–3 seconds until
OFF the Recorder?
Note
The backlight remains on during Settings and Calibration processes.
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 11). 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.
appears on the recorder screen.
Turn
Bravo pH Monitoring System 10 User Guide
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