Medtronic FGS-0634 Instructions for Use

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Bravo

Reflux Testing System

User Guide

DOC-4009-04

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

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

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



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 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

Performing a Bravo pH Study without pH Calibration



The actions of performing the study (testing the vacuum, placing the capsule, and instructing the patient) should be performed in one continuous sequence as follows.

Note

There are two types of Bravo pH capsules.

• If you are using a capsule–pH calibration not required, follow this procedure.

• If you are using a capsule–pH calibration required, follow the procedure Performing a Bravo pH Study with pH Calibration on page 26.

Warning

If performing a two-capsule procedure, both capsules must be the same type (requiring pH calibration or not requiring pH calibration).

Preparing the Delivery Device

1. Check the expiration date on the capsule (next to on the label).

2. Without bending or kinking the delivery device, carefully remove the Bravo delivery device with pH capsule from the external shipping box and then from the inner pouch (Figure 4).

Caution

Avoid bending or kinking the delivery device. Sharp bending or kinking can damage the delivery device, which will require the device to be discarded before use.

Figure 4. Remove Bravo pH capsule with delivery device from pouch.

Bravo Reflux Testing System 16 User Guide

3. Remove the capsule’s plastic cover and the magnetic clip (Figure 5). The capsule



Open the plastic cover.

Remove magnetic clip.

automatically turns on when the magnetic clip is removed. Set the magnetic clip aside.

Note

Keep the magnetic clip at least 2 meters away from the delivery device so that it will not interfere with the capsule. If a procedure is delayed, you can replace the magnetic clip on the capsule to return it to an inactive state until needed. Do not discard the magnetic clip until after the procedure has been performed.

Figure 5. Remove Bravo pH capsule shipping components.

Note

This capsule type does not have a soaker bulb in the delivery device.

Bravo Reflux Testing System 17 User Guide

4. After opening the capsule package, make sure that the capsule trocar needle has not

trocar needle

suction chamber

Place finger over suction chamber.

Remove finger.Connect vacuum

hose.

abc

vacuum

hose

vacuum port

advanced (Figure 6).

Figure 6. Make sure that the trocar needle has not advanced too far into the

chamber.

Setting up the Vacuum

1. Make sure that the vacuum flow knob is turned to maximum.

2. Connect the vacuum hose (supplied with the vacuum pump) to the vacuum port on the delivery device handle (Figure 7a).

Figure 7. Verify the vacuum function.

3. With your gloved finger covering the suction chamber (Figure 7b), verify that the vacuum gauge reading is at least 550 mmHg. Make a note of the gauge reading.

Bravo Reflux Testing System 18 User Guide



Note

At higher altitudes, the pressure readings may be lower. For different altitudes, use this table for the minimum recommended vacuum pressure. Contact Medtronic customer support for additional information.

Altitude

feet meters

0 0 550

2000 610 530

4000 1220 510

6000 1830 490

Minimum Pressure

mmHg

4. Remove your finger from the suction chamber. Verify that the vacuum gauge reading drops (Figure 7c) by at least 50 mmHg (500 mmHg or lower).

Caution

If the vacuum readings fail these minimum levels, remove the delivery device and perform the same action on the vacuum tube alone:

• Cover the tube with your finger. The vacuum gauge should read at least 575 mmHg. Remove your finger. The vacuum gauge should drop drastically (to zero or close to zero). If so, the vacuum unit is functioning properly. Perform the procedure with a different delivery device.

• If the vacuum fails to reach 575 mmHg or fails to drop to close to zero, the vacuum unit may require service. Contact Medtronic customer support.

5. Turn off the vacuum and detach the tubing from the delivery device.

6. Proceed to Starting Recording.

Starting Recording

1. If the recorder is turned off or in sleep mode, turn it on. 3

2. From the main menu, select Start Study and press Enter.

If the recorder detects that existing data from a previous study and has not yet been uploaded, this message appears:

Cancel and connect to PC.

• To stop and upload the existing data, press Cancel. Follow the directions (see Uploading

pH Data on page 41). When the data is uploaded, start the new study again by selecting

Start Study from the main menu.

• To continue (overwrite the existing data without uploading it), press Next and then press Yes to confirm that you want to overwrite the last study data.

Bravo Reflux Testing System 19 User Guide

Last study data not uploaded! To upload, press

3. The recorder starts searching for the capsule’s signal. This message appears:



Clearing data... and then Waiting for pH capsule 1.

4. When the recorder identifies the capsule, this message appears: Does this pH

capsule ID number match the delivery device number?

• The capsule ID is printed on the packaging label. Capsules–pH calibration not

required

ID. If the ID matches, press

have a 5-digit ID; capsules–pH calibration required have a 4-digit

Yes. If not, press No and the search begins again.

• If the recorder still does not recognize the capsule or displays a capsule mismatch error message, repeat the procedure. If the problem persists after three attempts, see Recorder Troubleshooting on page 45.

• For two-capsule studies, the process is repeated.

When capsule/recorder pairing is complete, the recorder automatically starts recording and the screen displays the symptom buttons (Figure 8).

Figure 8. Recorder screen displaying symptom buttons in Record mode.

5. Verify that the recorder is recording pH values and that the capsule status LED on the recorder is blinking.

Note

There are 30 minutes to attach the capsule to the patient’s esophagus before actual pH data starts to record for the configured study time duration.

6. Proceed to Placing the Capsule.

Placing the Capsule

1. Oral placement of the Bravo capsule can be performed either using: a. endoscopic measurement: using an endoscope, determine the desired location

for the capsule in the esophagus. Typically, the capsule is placed 6 cm above the squamo-columnar junction. Measure and record the distance traveled by the endoscope to the desired location.

b. manometric measurement: using a transnasal manometry catheter, determine

the desired location for the capsule in the esophagus. Typically, the capsule is placed 5 cm above the proximal aspect of the landmarks (LES). Use a correction factor of approximately 4 cm to account for the longer pathway that the manometry catheter has to travel through the nasopharynx.

2. Remove the endoscope or manometry catheter from the patient.

3. With the vacuum off, complete the following steps:

Bravo Reflux Testing System 20 User Guide

a. Mark the distance determined in step 1 on the delivery device. The depth

pH sensor

pH capsule

suction chamber

depth markings

vacuum

hose

markings on the delivery device are indexed from the capsule’s pH sensor (Figure 9).

b. Carefully advance the delivery device through the mouth (with the capsule

facing the patient’s tongue) to the desired location in the esophagus.

Caution If lubricants are used to ease placement insertion, do not cover the suction chamber with lubricant. This could interfere with the

attachment of the capsule.

Figure 9. Capsule depth markings are indexed from pH sensor.

c. Holding the delivery device as straight as possible in a relaxed horizontal

position, stabilize it by the patient’s mouth to make sure that it does not move.

Warning

Do not advance the delivery device into the trachea or lungs. Advancing the delivery device into the trachea or lungs can cause possible injury to the patient.

4. Endoscopically check the esophageal inlet to verify the desired placement of the delivery device in the esophagus. Carefully remove the delivery device immediately if it has entered the trachea.

5. After proper positioning of the delivery device: a. Attach the vacuum hose to the handle (Figure 7).

Bravo Reflux Testing System 21 User Guide

b. Turn on the vacuum source and verify that the gauge reading is the same as



you noted during vacuum setup.

Caution

If the minimum vacuum level (550 mmHg) is not obtained, reposition the Bravo delivery device to achieve proper vacuum.

Do not allow the delivery device to move during vacuum level acquisition. Failure to immobilize the delivery device can result in less than optimal attachment or non-attachment that will require the vacuum level acquisition process to be repeated.

6. After the vacuum level of at least 550 mmHg has been reached and the vacuum stabilizes, allow 30 seconds for the tissue to fill the suction chamber.

Caution

Do not proceed without waiting a full 30 seconds. Failure to wait a full 30 seconds may result in insufficient or no tissue filling the suction chamber. This can result in the capsule not being securely attached or not attached to the patient’s esophagus.

7. Remove the safety tab.

8. Swiftly press the plunger on top of the handle all the way down until it stops at its locking position. This advances the trocar needle into the suction chamber (Figure 10).

Warning

Press down on the plunger with a swift and smooth motion to actuate the delivery device mechanism. Pressing down on the plunger too slowly may result in the capsule not properly attaching to the patient’s esophagus or not detaching from the delivery device.

Do not rotate the plunger while depressing it!

Note

• Your hand may feel the delivery mechanism actuate, and you may hear a click when this occurs.

• Remove your thumb after the plunger locks and before you begin rotating it 1/8 of a turn.

Bravo Reflux Testing System 22 User Guide

Press the plunger down to the locking position and release it.

Rotate the plunger clockwise until the white line on the plunger lines up with the white upward arrow.

Figure 10. Attach the capsule to the patient’s esophagus.

9. Using your thumb, rotate the plunger from the side one-eighth (1/8) of a turn clockwise to release the capsule from the delivery device (Figure 11). The plunger springs up so that a white line is visible on the sixth rib of the plunger (Figure 12).

Figure 11. Release the capsule from the delivery device.

Bravo Reflux Testing System 23 User Guide

If the plunger does not automatically spring up, push it up gently with your thumb.



Do not cover the hole at the bottom of the handle with your hand.

The plunger should spring back up automatically. Verify that the plunger springs back to the white line marking the plunger’s sixth rib.

If the plunger does not automatically spring up, use your thumb to lightly push it up.

These steps release the capsule from the delivery device.

Figure 12. Release the capsule from the delivery device, cont.

Warning

Do not rotate or otherwise force the plunger beyond the white line on the barrel. Rotating or forcing the plunger beyond this may result in possible damage to the delivery device. This may also interfere with the detachment of the capsule from the delivery device, and cause possible injury to the patient.

Note

Following correct rotation of the plunger, the white marking should now be visible on the sixth rib of the plunger. If not, use your thumb to raise the plunger until the white marking is visible.

Warning

If problems occur with capsule detachment, see Delivery Device Disassembly Procedure on page 43.

10. Turn off the vacuum source. Remove the delivery device and discard it according to local waste management regulations.

Bravo Reflux Testing System 24 User Guide

Warning

Do not remove the delivery device from the patient with the vacuum source on. Removing the device with the vacuum source on can result in dislodgement of the capsule or possible injury to the patient’s esophagus.

11. Endoscopically confirm the capsule’s attachment.



Caution

Avoid contacting the capsule with the endoscope. Contact between the endoscope and capsule may result in the dislodgement of the capsule.

12. Confirm that the recorder is recording pH values and that the capsule status LED on the recorder is blinking in blue.

Note

The recorder's backlight display turns off after 30 seconds (default) to conserve battery life. Press any key to activate the recorder's screen during a study.

13. Proceed to Reviewing Instructions with Patients on page 39.

Stopping a pH Study

The study completes automatically when the recorder no longer collects pH data and the recorder screen turns off. The study data is stored in the recorder until it is cleared.

To stop a study manually (before its intended completion):

1. Press the on/off button for several seconds until this message is displayed:

sure you want to stop the pH study?

2. Select your action:

• If you do nothing or select

• If you select

upload, connect recorder to PC.

Remember: if you stop the study, you must upload this data before the recorder can be used for the next study.

Yes, this message is displayed: Last study data not uploaded! To

No, the study continues uninterrupted.

Are you

Bravo Reflux Testing System 25 User Guide

Performing a Bravo pH Study with pH Calibration



The actions of performing the study (calibrating the capsule, testing the vacuum, placing the capsule, and instructing the patient) should be performed in one continuous sequence as follows.

Calibrating Capsules

Calibration is the process of making sure that the capsule is reading pH levels properly. You must go through calibration for each capsule.

Note

There are two types of Bravo pH capsules.

• If you are using a capsule–pH calibration not required, follow the procedure Performing a Bravo pH Study without pH Calibration on page 16.

• If you are using a capsule–pH calibration required, follow this procedure.

Warning

If performing a two-capsule procedure, both capsules must be the same type (requiring pH calibration or not requiring pH calibration).

Note

If you need to change the number of capsules or the study duration, select Settings from the main menu and make the necessary changes.

Existing Data

If data exists from a previous study and has not yet been uploaded, you must first do so before you can start calibration. The record screen shows the message:

not uploaded! To upload, connect to PC.

•

To stop calibration and upload the existing data, press Cancel. Follow the directions

Last study data

in Reflux software (see Uploading pH Data on page 41.) When the data is uploaded, start the new study again by selecting

• To continue (overwrite the existing data without uploading it), press Next and then

Calibrate from the main menu.

press Yes to confirm that you want to overwrite the last study data. The message

Clearing data... appears, and then the recorder continues with the calibration

process.

Starting Calibration

If the message about existing data does not appear, begin calibration as follows:

1. Select

Start Study from the main menu.

Bravo Reflux Testing System 26 User Guide

The message This capsule requires calibration. Calibrate? appears on the screen,



along with current settings (Date/Time, # of Capsules, and Study Duration). Press

Yes to start calibration or No to return to the main screen.

Note

The backlight stays on during calibration, except during the 10-minute pre-soak stage.

This message appears: Place pH Capsule #1 in pH 7.01 and press Start to

calibrate.

2. Position the calibration stand on a level surface and place a clean calibration tube into each of the four holders. Place the recorder on the calibration stand (Figure 16).

3. Check the expiration date on the buffer fluid bottles (next to on the label).

4. Fill each of the four tubes in the calibration stand halfway (enough to be able to cover the capsule when it is inserted) as follows. The buffer solutions should be at room temperature (20–25 °C, 68–77 °F).

• tube 1: pH 7.01 buffer solution

• tube 2: sterile water

• tube 3: pH 1.07 buffer solution

• tube 4: sterile water

5. Check the expiration date on the capsule (next to on the label).

6. Without bending or kinking the delivery device, carefully remove the Bravo delivery device with pH capsule from the external shipping box and then from the inner pouch (Figure 13).

Caution

Avoid bending or kinking the delivery device. Sharp bending or kinking can damage the delivery device, which will require the device to be discarded before use.

Bravo Reflux Testing System 27 User Guide



Open the plastic cover.

Remove magnetic clip.

Remove soaker bulb.

Figure 13. Remove Bravo pH capsule with delivery device from pouch.

7. Remove the capsule’s plastic cover, the reference sensor cover (soaker bulb cover), and the magnetic clip (Figure 14). Set the magnetic clip aside.

Note

Figure 14. Remove Bravo pH capsule shipping components.

Bravo Reflux Testing System 28 User Guide



trocar needle

suction chamber

Note

The capsule automatically turns on when the magnetic clip is removed. In addition, if the recorder is turned on, you can see the capsule status LED blinking on the recorder.

8. Check the soaker bulb for fluid and set aside.

Note

Even if the soaker bulb doesn’t show the presence of liquid, the capsule can calibrate as usual. Perform the capsule calibration as per instructions. If the capsule fails to calibrate, contact your customer support representative.

9. After opening the capsule package, make sure that the capsule trocar needle has not advanced (Figure 15).

Figure 15. Make sure that the trocar needle has not advanced too far into the

chamber.

Bravo Reflux Testing System 29 User Guide

10. Without bending or kinking the delivery device, place the delivery device handle

calibration tube

delivery device handle

into the calibration stand (Figure 16).

Figure 16. Delivery device in calibration stand.

11. Carefully place the capsule into the pH 7.01 buffer solution calibration tube as indicated on the recorder screen.

Caution

When placing the capsule into the calibration tube, do not allow either part of the pH sensor (the short silver-colored antimony and long clear reference sensor) to catch on the edge of the calibration tube, as this can damage the pH sensor. Avoid the tube edge while carefully lowering the capsule into the solution. Any damage to the pH sensor

will require the delivery device to be discarded before use.

12. Make sure that the capsule is completely covered with the buffer solution. Gently agitate the capsule to remove any air bubbles.

Caution

After agitating to remove air bubbles, do not move the capsule again or move the calibration stand during the calibration process.

13. On the recorder, press This message appears: Waiting for pH capsule 1.

14. When the recorder identifies the capsule, this message appears: Does this pH

capsule ID number match the delivery device number?

• The capsule ID is printed on the packaging label. If the ID matches, press

not, press No and the search begins again.

• If the recorder still does not recognize the capsule or displays an error message,

repeat the procedure. If the problem persists after three attempts, see Recorder Troubleshooting on page 45.

Bravo Reflux Testing System 30 User Guide

Start. The recorder starts searching for the capsule’s signal.

Yes . If

15. Press Yes. This message appears: Initiating 10 minute pre-soaking.



Note

If you press Skip, the recorder goes directly to the next step, and the action (skipping pre-soak) is written to the recorder log.

If you did not skip (that is, if you pressed Yes), the backlight goes out. It automatically turns back on at the end of the 10 minute pre-soak period.

When the pre-soak period ends (or is canceled by pressing appears: pH 7.01 calibrating.

At the end of this calibration period, the recorder beeps and this message appears:

Rinse the pH capsule in sterile water and press Next.

16. Rinse the capsule in sterile water. Press Next. This message appears: Place capsule

#1 in pH 1.07 and press Start to calibrate.

17. Place the capsule in the pH 1.07 solution and press Start.

At the end of this calibration period, the recorder beeps and this message appears:

pH capsule ID xxxx calibrated. (where xxxx is the capsule ID).

Caution

If either part of the calibration process (pH 7.01 or 1.07) fails, see Recorder Troubleshooting on page 45.

Skip), this message

18. Press

19. Proceed to Setting up the Vacuum on page 32.

Bravo Reflux Testing System 31 User Guide

OK. The calibration data is saved and the recorder main menu appears with the

cursor ready at Start study.

Note

If you are performing a two-capsule procedure, the recorder guides you through the same calibration process for the second capsule.

After the first capsule is calibrated, it can remain outside the buffer solutions for up to 60 minutes before use.

Note

If you are not going to place the capsule in the patient immediately, return the capsule to the pH 7.01 buffer solution. It may remain there for up to 8 hours. Rinse the capsule in sterile water before use.

Setting up the Vacuum



Place finger over suction chamber.

Remove finger.Connect vacuum

hose.

abc

vacuum

hose

vacuum port

1. Make sure that the vacuum flow knob is turned to maximum.

2. Connect the vacuum hose (supplied with the vacuum pump) to the vacuum port on the delivery device handle (Figure 7a).

Figure 17. Verify the vacuum function.

3. With your gloved finger covering the suction chamber (Figure 7b), verify that the vacuum gauge reading is at least 550 mmHg. Make a note of the gauge reading.

Note

Altitude

feet meters

0 0 550

2000 610 530

4000 1220 510

6000 1830 490

Minimum Pressure

mmHg

4. Remove your finger from the suction chamber. Verify that the vacuum gauge reading drops (Figure 7c) by at least 50 mmHg (500 mmHg or lower).

Bravo Reflux Testing System 32 User Guide

Caution



If the vacuum readings fail these required minimum levels, remove the delivery device and perform the same action on the vacuum tube alone:

• If the vacuum fails to reach 575 mmHg or fails to drop to close to zero, the vacuum unit may require service. Contact Medtronic customer support.

5. Turn off the vacuum and detach the tubing from the delivery device.

6. Proceed to Starting Recording.

Starting Recording

1. If the recorder is turned off or in sleep mode, turn it on.

2. From the main menu, select Start Study and press Enter.

If the recorder detects a conflict with the capsule ID, this message appears:

ID mismatch. Use pH capsule ID: xxxx.

See Recorder Troubleshooting on page 45.

Capsule

3. Verify that the recorder is recording pH values.

Note

The recorder's backlight display turns off after 30 seconds (default) to conserve battery life. Press any key to activate the recorder's screen during a study.

4. Proceed to Placing the Capsule on page 34.

Bravo Reflux Testing System 33 User Guide

Placing the Capsule

pH sensor

pH capsule

suction chamber

depth markings

vacuum

hose

1. Oral placement of the Bravo capsule can be performed either using: a. endoscopic measurement: using an endoscope, determine the desired location

for the capsule in the esophagus. Typically, the capsule is placed 6 cm above the squamo-columnar junction. Measure and record the distance traveled by the endoscope to the desired location.

b. manometric measurement: using a transnasal manometry catheter, determine

2. Remove the endoscope or manometry catheter from the patient.

3. With the vacuum off, complete the following steps: a. Remove the capsule from the buffer solution and rinse it in sterile water.

b. Mark the distance determined in step 1 on the delivery device. The depth

markings on the delivery device are indexed from the capsule’s pH sensor (Figure 18).

c. Carefully advance the delivery device through the mouth (with the capsule

facing the patient’s tongue) to the desired location in the esophagus.

Caution If lubricants are used to ease placement insertion, do not cover the suction chamber with lubricant. This could interfere with the

attachment of the capsule.

Figure 18. Capsule depth markings are indexed from pH sensor.

Bravo Reflux Testing System 34 User Guide

d. Holding the delivery device as straight as possible in a relaxed horizontal

position, stabilize it by the patient’s mouth to make sure that it does not move.

Warning

Do not advance the delivery device into the trachea or lungs. Advancing the delivery device into the trachea or lungs can cause possible injury to the patient.

4. Endoscopically check the esophageal inlet to verify the desired placement of the delivery device in the esophagus. Carefully remove the delivery device immediately if it has entered the trachea.

5. After proper positioning of the delivery device: a. Attach the vacuum hose to the handle (Figure 17).

b. Turn on the vacuum source and verify that the gauge reading is the same as

you noted during vacuum setup.

Caution

If the minimum vacuum level (550 mmHg) is not obtained, reposition the Bravo delivery device to achieve proper vacuum.

6. After the vacuum level of at least 550 mmHg has been reached and the vacuum stabilizes, allow 30 seconds for the tissue to fill the suction chamber.

Caution

7. Remove the safety tab:

Bravo Reflux Testing System 35 User Guide

8. Swiftly press the plunger on top of the handle all the way down until it stops at its



Press the plunger down to the locking position and release it.

Rotate the plunger clockwise until the white line on the plunger lines up with the white upward arrow.

locking position. This advances the trocar needle into the suction chamber (Figure 19).

Warning

Do not rotate the plunger while depressing it!

Note

• Your hand may feel the delivery mechanism actuate, and you may hear a click when this occurs.

• Remove your thumb after the plunger locks and before you begin rotating it 1/8 of a turn.

Figure 19. Attach the capsule to the patient’s esophagus.

9. Using your thumb, rotate the plunger from the side one-eighth (1/8) of a turn clockwise to release the capsule from the delivery device (Figure 20). The plunger springs up so that a white line is visible on the sixth rib of the plunger (Figure 21).

Figure 20. Release the capsule from the delivery device.

Bravo Reflux Testing System 36 User Guide

If the plunger does not automatically spring up, push it up gently with your thumb.



Do not cover the hole at the bottom of the handle with your hand.

The plunger should spring back up automatically. Verify that the plunger springs back to the white line marking the plunger’s sixth rib.

If the plunger does not automatically spring up, use your thumb to lightly push it up.

These steps release the capsule from the delivery device.

Figure 21. Release the capsule from the delivery device, cont.

Warning

Note

Following correct rotation of the plunger, the white marking should now be visible on the sixth rib of the plunger. If not, use your thumb to raise the plunger until the white marking is visible.

Warning

If problems occur with capsule detachment, see Delivery Device Disassembly Procedure on page 43.

10. Turn off the vacuum source. Remove the delivery device and discard it according to local waste management regulations.

Bravo Reflux Testing System 37 User Guide

Warning

11. Endoscopically confirm the capsule’s attachment.



Caution

Avoid contacting the capsule with the endoscope. Contact between the endoscope and capsule may result in the dislodgement of the capsule.

12. Confirm that the recorder is recording pH values and that the capsule status LED on the recorder is blinking in blue.

Note

The recorder's backlight display turns off after 30 seconds (default) to conserve battery life. Press any key to activate the recorder's screen during a study.

13. Proceed to Reviewing Instructions with Patients on page 39.

Stopping a pH Study

The study completes automatically at the end of the study duration (defined in Settings). The recorder stops collecting pH data and the recorder screen turns off. The study data is stored in the recorder until it is cleared.

To stop a study manually (before its intended completion):

1. Press the on/off button for several seconds until this message is displayed:

sure you want to stop the pH study?

2. Select your action:

• If you do nothing or select No, the study continues uninterrupted.

• If you select

upload, connect recorder to PC.

Remember: if you stop the study, you must upload the data to unlock the recorder before you can continue.

Yes, this message is displayed: Last study data not uploaded! To

Are you

Bravo Reflux Testing System 38 User Guide

Reviewing Instructions with Patients



meal

supine

regurgitation

capsule LED

chest pain

heartburn

When this button is pressed...

This icon appears on the screen

After capsule placement the patient may stay at the clinic/hospital, or return home. Review the following information with the patient.

1. Familiarize the patient with the recorder. Instruct the patient to press the appropriate button at the first sensation of the symptom (chest pain, regurgitation, or heartburn).

Note

The default meaning of recorder symptom buttons can be changed from the Reflux software (refer to the user guide for details). If you are using the buttons for other symptoms, make sure to explain the function of each symptom button to the patient.

Figure 22. Default values of symptom buttons.

2. Explain that the patient must first press any button to turn on the backlight, and then press the appropriate symptom or event button.

3. Show the patient that the indicator light on the symptom button (Figure 22) illuminates for 3 seconds confirming that a symptom button was pressed.

4. Explain the beep sound (if the recorder was programmed to beep when a symptom button is pressed).

5. Explain the use of the Patient Diary. Patients need to write down eating, lying down (supine), and other user-defined periods, using the time on the recorder’s screen for the start and end times.

User-defined periods allow the patient to record a period of time when they are engaged in an activity that the physician determined may affect pH readings, such as smoking, exercising, or wheezing.

Bravo Reflux Testing System 39 User Guide

6. Instruct the patient to make sure that the recorder is always monitoring the capsule:

• The patient must stay within 2 meters of the recorder during the study except, as

necessary, for bathing. The recorder is not water resistant and should not be worn in the shower or in other wet environments.

• When resting or lying down, place the recorder on a night stand near the bed, the

buttons turned toward the patient both for convenience of reaching it for possible symptom recording as well as for optimal reception.

• If a night stand is not near the bed, the patient should clip the recorder to the

pillow, making sure the buttons face the patient.

• If the recorder is too far from the capsule, it beeps for up to 30 seconds and the

capsule number icon disappears from the screen (

for single-capsule

procedures, for two-capsule procedures). This indicates that the transmission from the capsule to the recorder has been interrupted. The patient

should hold the recorder on the chest until

or appears.

• This beep can also occur if there are other electronic or electrical devices

operating at the same frequencies as the recorder. Instruct the patient to move away from these other devices; if the capsule number icon appears, the problem may have been caused by interference from another device.

• Instruct the patient to contact the doctor if or

disappears from the

recorder screen or if there are any problems or questions during the study.

7. Place the recorder in the case and show the patient how to adjust the shoulder strap.

Warning

The recorder must be worn over clothing.

If wearing the recorder with the shoulder strap, the patient must stay clear of moving equipment or machines that are potentially hazardous. If the strap becomes entangled with a moving part, it could cause the patient to be pulled into a dangerous position. This could result in possible patient injury.

Do not allow children to wear or play with the recorder shoulder strap either with or without the case. It is intended only for the prescribed use by an adult. Use of the shoulder strap by a child could result in possible injury. Instead, it is recommended to use the belt clip for children.

8. Instruct the patient about what to expect when the capsule detaches.

9. Instruct the patient to return the recorder at the completion of the study.

Bravo Reflux Testing System 40 User Guide

Uploading pH Data



Note

To perform multiple uploads from the same recorder, disconnect the recorder from the USB and reconnect it again between uploads.

Note

The analysis software that can be used to view and analyze data from a pH study depends on which capsule type was used:

• capsule–pH calibration not required: Reflux software version 6.1 or higher

• capsule–pH calibration required: AccuView 5.2 or Reflux software version 6.0 or higher

1. Connect the Bravo recorder to your PC using the supplied USB cable.

2. Open the Reflux software by double-clicking the icon on your desktop.

3. Click Upload. A progress bar appears. Once the upload is complete, the

Edit Information & Diary

screen appears.

The capsule ID automatically appears in

ID field. You can use

the this ID or replace it with the patient ID.

If you are using Reflux software v6.1, the software detects the number of capsules and the capsules pH calibration type. It applies the appropriate protocol in the field.

4. Complete the Information and Diary fields and click OK.

Bravo Reflux Testing System 41 User Guide

Protocol

Recorder Maintenance

Safety and Technical Checks

There are no required safety or technical checks, and no periodic maintenance for the recorder.

The recorder contains no serviceable components apart from the battery. If the recorder requires repair or is nonfunctional, contact customer support.

Cleaning the Recorder

Clean the recorder after each study.

1. Turn off the recorder.

2. Wipe the exterior surface of the recorder with 70–90% isopropyl alcohol.

3. Allow any alcohol to dry thoroughly before using the recorder.

Caution

Do not allow liquid to get into the recorder body or inside the front cover. The recorder is not fluid resistant. Allowing any fluid (alcohol, water, etc.) inside of the recorder can damage the recorder and cause it to malfunction.

Cleaning the Case and Strap

Wipe the case and strap with any commonly-used disinfectant.

Servicing the Battery

The recorder operates on one internal rechargeable lithium battery. When the battery has been recharged 275 times, a message appears on the screen reminding you to replace the battery.

Contact customer support to have the battery replaced.

Bravo Reflux Testing System 42 User Guide

Troubleshooting



Delivery Device Disassembly Procedure

If the capsule is attached to the patient’s esophageal tissue, but will not release from the delivery device, we recommend this procedure.

Caution

When performing the following steps to remove the capsule, it is extremely important to minimize movement of the capsule and the patient. Any movement could cause tissue injury at the site of the capsule attachment.

1. If available, insert an endoscope and confirm tissue has been pinned and the capsule has not been released from the delivery device. Use care when inserting the endoscope, and avoid force upon the capsule and the delivery device. Remove endoscope. If an endoscope is not available, proceed to step 2.

2. See Figure 23. Secure delivery device near biteblock or near nasal passage using a hemostat clamp. An assistant should continue to firmly hold the shaft of the delivery device with a hemostat until the release procedure (described below) is completed.

Note

For the following steps, moderate force may be needed to disassemble the Bravo delivery device handle.

Warning

During the disassembly of the handle, position the handle away from the patient’s face while protecting the patient’s mouth and nose, and away from the eyes of the patient and nearby staff. Plastic parts may break off during handle disassembly, resulting in possible injury to the patient and clinical staff.

Figure 23. Delivery device secured at mouth (or nose, if applicable) using a

hemostat with hand. Keep a firm grip on the hemostat throughout the release procedure.

Bravo Reflux Testing System 43 User Guide

3. With gloved hands, place one hand onto the handle portion and one hand on the



suction port part as shown. Firm force may be needed to induce separation of these two parts. When the two parts have separated, go to step 4.

Note

Be careful not to transfer force or motion to the capsule portion of the delivery device.

Figure 24. Break handle as indicated.

4. See Figure 25. Withdraw the handle a minimum of 4 cm. When performing this action, the wire that secures the capsule is also withdrawn and will automatically release the capsule.

Note

If it is difficult to withdraw the handle and you feel resistance, release the hemostat to allow the handle to be retracted. Make sure not to pull on the shaft to avoid transferring force to the capsule.

Figure 25. Withdraw the handle 4 cm minimum. THIS ACTION WILL RELEASE

THE CAPSULE. If the wires are difficult to withdraw, remove the hemostat. This will release the capsule at distal end.

5. When the capsule releases from the delivery device, remove the delivery device from the patient.

6. If possible, use an endoscope to confirm that the capsule remained attached to the esophageal tissue.

Bravo Reflux Testing System 44 User Guide

Recorder Troubleshooting

Following is a list of problems you may encounter while operating the recorder. If you cannot resolve the problem with the solution provided, or you do not see the problem listed, contact your product customer support.

Problem Cause Solution

Initial Startup

Recorder displays message:

ERROR

Recorder displays message:

REPLACE BATTERY

Recorder is locked (no buttons work) and displays message:

Last study data not uploaded! To upload, connect recorder to PC.

Calibration (for capsules–pH calibration required only)

Recorder displays message:

Calibration done. To use, press Cancel. To start new, press Yes.

Recorder displays message:

Charge battery.

Recorder displays message:

Capsule 1 Calibration Error

Error 1: Unexpected pH value

Error 2: Slope too low Difference in mV between

Error 3: Slope too high Difference in mV between

Error 4: Signal unstable Recorder cannot detect stable

General recorder problem. Contact customer support to

Battery voltage low. Contact customer support to

A study is done but the data has not yet been uploaded from the recorder.

Calibration has already been performed but the calibration data has not yet been used in a study.

Recorder battery is below 30% capacity.

(various) Press Help to display error

Capsule sends what appears to be a pH value, but it is outside expected range (pH

7.01 to 1.07).

signals read by capsule during calibration (that is, difference between pH 7.01 and pH 1.07 solutions) is lower than expected.

signals read by capsule during calibration is greater than expected.

signal from capsule within 60 seconds during calibration.

arrange servicing for recorder.

arrange battery replacement for recorder.

Connect the recorder to the PC and follow the instructions on the recorder screen.

Perform the study with this calibration data or redo calibration.

Connect recorder to charger. Allow to fully recharge (may take several hours).

message.

For each of these calibration messages, try:

1. Replace buffer solution.

2. Try calibrating a new pH capsule.

If error persists, contact customer support.

Bravo Reflux Testing System 45 User Guide

Problem Cause Solution

Recorder displays message: Listening for caps... and does not progress further.

Start Study

Recorder displays message:

Charge battery.

Recorder displays message:

Settings for two capsules but only capsule xxxx found. Start recording?

Recorder displays message:

Capsule ID mismatch. Use capsule ID: xxxx.

Recorder displays message:

Capsule ID mismatch. Use capsule ID: 0000.

No pH display on recorder screen Capsule out-of-range. Move recorder closer to

Data Transfer

Recorder displays the

disconnect icon

Data upload fails. Communication error. Disconnect the recorder from

do not

Capsule out-of-range. Try each of these:

1. Move recorder closer to capsule.

2. Replace buffer solution.

3. Try calibrating a new pH capsule.

If error persists, contact customer support.

Recorder battery is below 90% capacity.

Recorder was configured for two-capsule study, but is now only detecting signal of one capsule.

This can also happen if the two capsules are not the same type (one requires calibration and one doesn’t).

Capsule was not calibrated using this recorder, or there may be interference with another capsule in the area.

Capsules–pH calibration required have a four-digit ID. Capsules–pH calibration not required have a five-digit ID.

Calibration data is missing or invalid.

Capsule not in contact with fluid.

Recorder is connected to PC software application and data is being transferred.

Connect recorder to charger. Allow it to fully recharge (may take up to 7 hours).

If you continue recording, you will only collect data for the capsule identified in this error message.

Otherwise, press ESC, perform calibration with another capsule, and continue.

Try each of these:

1. Select the recorder that was calibrated to the capsule being used

2. Move recorder closer to capsule (place recorder on patient’s chest).

3. Remove patient from the area (100 meters) and try again.

Recalibrate the capsule. Make sure that you get the message

pH capsule #1 calibrated.

capsule.

Place capsule in buffer solution.

This is normal. Do nothing (do not disconnect recorder from USB cable until this icon is no longer displayed, indicating that data transfer has finished).

the USB cable and then reconnect it.

Bravo Reflux Testing System 46 User Guide

Problem Cause Solution

Patient Interface

Long beep and patient display flashes battery symbol

Long beep (up to 30 seconds)

and the capsule indicator or

disappears from the

display

Indicator light does not blink when a symptom button is pressed

Indicator light blinks but recorder does not beep when a symptom button is pressed

Patient display does not show time

Patient display shows time, but not pH reading

Patient display shows Hi (H) pH level momentarily out-of-

Patient display shows Lo (L) pH level momentarily out-of-

Recorder overheats On rare occasions, the

Battery low. Recharge.

Signal from capsule lost. Move recorder closer to

Interference from 433 MHz electromagnetic sources.

Indicator light or button not functioning.

Recorder was programmed not to beep when symptom button is pressed.

Battery is depleted. Contact customer support to

Recorder was programmed not to display pH reading.

range (too high).

range (too low).

recorder may become too warm for patient comfort.

capsule until capsule indicator reappears.

Move recorder away from all possible sources of radio waves.

Manually record symptoms. Contact customer support to arrange servicing for recorder.

Program recorder to beep when symptom button is pressed. See Choosing Study Settings on page 14.

arrange battery service.

Reprogram recorder to display pH reading. See Choosing Study Settings on page 14.

Continue with study (no action required).

Stop the recorder. Repeat the study with a different recorder.

Bravo Reflux Testing System 47 User Guide

Appendix A: Technical Data

Bravo Recorder

Power Supply: One lithium polymer battery (3.7 volt)

Size: Height: 90 mm (3.5 in.)

Weight: 150 g (5.3 oz)

Operating, Transporting, and Storage Temperature:

Operating and Storage Pressure: 70kPa-106kPa

Operating, Transporting, and Storage Humidity:

Number of Channels: 1 or 2 capsules

Symptom Buttons: Chest pain

Memory: Code: 128 Kilobytes, 16 K Sram

Recording Time (study duration): 24, 48, or 96 hours (selectable)

Capsule Sampling Interval: 6 seconds, transmits every 12 seconds

Measuring Range: pH level

pH accuracy:

Transmission of Data: USB

Communication Frequency: 433.9 MHz

Bandwidth of the Receiving Section: Maximum 600 KHz

Protection from Electric Shock: Internally powered BF equipment

Mode of Operation: Continuous

Water Ingress Protection: Ordinary

Capsule Transmission Duty Cycle: Every 12 seconds

Width: 100 mm (3.9 in.)

Depth: 30 mm (1.2 in.)

0–40 °C (32–104 °F)

0 - 85% relative humidity (noncondensing)

Regurgitation

Heartburn

Data: 8 Mbytes

1.0–8.0 for capsules–pH calibration required;

2.0–8.0 for capsules–pH calibration not required

pH accuracy capsules–pH calibration required +/- 0.5 pH @ pH4, +/-1.0 pH @ pH1-pH8 pH accuracy capsules–pH calibration not required +/- 0.5 pH @ pH4, +/-1.0 pH @ pH2-pH8

Bravo Reflux Testing System 48 User Guide

Recorder Servicing

The recorder does not require routine servicing of internal components, unless the recorder becomes damaged. For service, contact the appropriate customer support representative.

USB Cable

Length: 1 meter

Charger

Input: 100 to 240 V (0.45-0.2 Amp, 50/60 Hz)

Output: 5 V 5 V (3 Amp, 15 W max)

Type: GEM 1 8 I 0 5

Manufacturer: MEAN WELL

Battery

Weight +

Rated capacity 1070 mAh to 110 mAh

Nominal voltage 3.7 V

Max. operating voltage range 2.75 V to 4.2 V

Expected cycle life 500 cycles

Temperature range charge 0°C to 45°C

Humidity 65 +

25 g

discharge -20°C to 60°C

20% RH

Essential Performance of Bravo Recorder

The Bravo System records and provides pH data of the distal esophagus with defined accuracy per system specification. It allows a trained operator to identify any significant defects in the provision of these data.

Bravo Reflux Testing System 49 User Guide

Electromagnetic Compatibility Declaration (EN / IEC 60601-1-2)

This equipment has been tested and found to comply with EN / IEC 60601-1-2. Compliance with EN / IEC 60601-1-2 shows the equipment is reasonably protected against harmful interference in a typical medical installation. Tables 1, 2, and 3 apply to Given Imaging in-line powered and battery-powered external devices.

Caution

Bravo recorder needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents.

Portable and mobile RF communications equipment can affect Bravo recorder.

The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the Bravo recorder as replacement parts for internal components, may result in increased emissions or decreased immunity of the Bravo recorder.

The Bravo recorder should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Bravo recorder should be observed to verify normal operation in the configuration in which it will be used.

Use of accessories, transducers, and cables with the Bravo recorder other than those specified may result in increased emissions or decreased immunity of the Bravo recorder.

The Bravo recorder may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements.

Table 1. Electromagnetic emissions

Bravo recorder is intended for use in the electromagnetic environment specified below. The customer or the user of Bravo recorder should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

Non-ionizing electromagnetic emissions CISPR 11

Harmonic emissions EN 61000-3-2

Voltage fluctuations/flicker emissions EN 61000-3-3

Group 1 (Bravo pH recorder)

Class B (Bravo pH recorder)

Not Applicable (Battery-powered devices)

The Bravo recorder uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The Bravo recorder is suitable for use in all establishments, including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Bravo Reflux Testing System 50 User Guide

Table 2. Electromagnetic immunity

Bravo recorder is intended for use in the electromagnetic environment specified below. The customer or the user of Bravo recorder should assure that it is used in such an environment.

Immunity test EN 60601 test

Electrostatic discharge (ESD): EN 61000-4-2]

Electrical fast transient/ burst: EN 61000-4-4

Surge: EN 61000-4-5 N/A

Voltage dips, short interruptions and voltage variations on power supply input lines: EN 61000-4-11

Power frequency (50/ 60 Hz) magnetic field: EN 61000-4-8

[All devices]

±8 kV contact ±15 kV air

N/A

N/A <5% U

N/A 40% U

N/A 70% U

N/A <5% U

level

30 A/m 30 A/m

Compliance

level

±8 kV contact ±15 kV air

±2 kV for power supply lines ±1 kV for input/ output lines

±1 kV differential mode ±2 kV common mode

(>95% dip in UT) for 0.5 cycle

(60% dip in UT) for 5 cycles

(30% dip in UT) for 25 cycles

(>95% dip in UT) for 5 sec

Electromagnetic environment – guidance

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Not Applicable. Battery-powered device with signal line not longer than 1 meter.

Not Applicable. Battery-powered device.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Bravo Reflux Testing System 51 User Guide

Table 2. Electromagnetic immunity (continued)

Bravo recorder is intended for use in the electromagnetic environment specified below. The customer or the user of Bravo recorder should assure that it is used in such an environment.

Immunity test EN 60601 test

level

Compliance

level

Electromagnetic environment – guidance

Recommended separation distance

Portable and mobile communication equipment should be used no closer to any part of the Bravo System, including cables, than the recommended separation distance (d) calculated from the equation applicable to the frequency of the transmitter.

6 V

Conducted RF IEC 61000-4-6

Radiated RF

IEC 61000-4-3

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

rms

150 kHz to 80

MHz

10 V/m

80 MHz to 2.7

GHz

NOTE 1: At 80 and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Bravo System.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.

3 V

/ 6 V

rms

150 kHz to 80

rms

MHz

10 V/m

d = 1.2 P

412.224 - 455.616 MHz range is exclusion band for the Bravo recorder in Rx mode. The Bravo recorder in Rx mode has no immunity against electromagnetic energy in this band in order to perform its intended function. The nearby electronic equipment may affect the system. Recommended separation distance:

d = 1.2 P, 80–800 MHz range

d = 2.3 P, 800–2700 MHz range

Bravo Reflux Testing System 52 User Guide

Table 3. Recommended separation distances between portable and mobile electromagnetic communication

Bravo recorder is intended for use in an electromagnetic environment in which radiated electromagnetic disturbances are controlled. The customer or the user of the Bravo recorder can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile communication equipment (transmitters) and the Bravo recorder as recommended below, according to the maximum output power of the communication equipment.

Rated maximum output power of Transmitter W

80 to 412.224

equipment and Bravo recorder

MHz

412.224 to

455.616 MHz

455.616 to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 P d = 1.2 P d = 1.2 P d = 2.3 P

0,01

0,1

100

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

NOTE 3: In the band 412.224 to 455.616 MHz, Bravo recorder in Rx mode has no immunity against electromagnetic energy in order to perform its intended function. Nearby electronic equipment may affect the system. Immunity within this band is provided in upload mode of operation only.

0.12 0.12 0.12 0.23

0.38 0.38 0.38 0.74

1.2 1.2 1.2 2.3

3.8 3.8 3.8 7.4

12 12 12 23

Table 4. Transmitter requirements

Description Specification

Operating frequency

Transmission type

Effective radiated power

433.9 MHz

Amplitude shift key (ASK)

29.7 µW

Bravo Reflux Testing System 53 User Guide

Bravo Capsule Specifications

Materials

Cap Makrolon®

Shell Makrolon®

Reference sensor polyethylene terephthalate

Filler material 2 component epoxy

Dimensions

Output & Transmission

Storage & Operation

Length 28 mm

Width 6.5 mm

Height 6.0 mm

Format Amplitude-shift keying

Frequency 433.92 MHz

Rate 60 ms every 12 seconds

Storage temperature 15–45°C (59–113 °F)

Operation temp. 20–40°C (68–104°F)

Storage humidity 0 - 85% RH

Operation humidity 0-100 RH

Storage & operation pressure 70kPa-106kPa

Bravo Delivery Device Specifications

Materials

Proboscis & Boot Aliphatic, polyether-based TPU

Nest Acrylonitrile Butadiene Styrene

Foam Polyethelyne (PE)

Tube Polyamide (PA)

Cable gauge 2.4 mm (7 Fr)

Bravo Reflux Testing System 54 User Guide

Appendix B: Symbols on Package Labeling

Refer to the device to see which symbols apply to this product.

Symbol Symbol

number

MDD 93/42/ EEC, Annex

XII

ISO 15223-1

Clause 5.1.2

ISO 15223-1

Clause 5.3.1

ISO 15223-1

Clause 5.4.4

ISO 15223-1

Clause 5.4.3

www.medtronic.com/manuals

ISO 15223-1

Clause 5.1.5

Symbol title Description

CE marking To indicate conformity with the

provisions of MDD 93/42/EEC Directive.

Authorized representative in

Indicates the authorized representative

in the European Community. the European Community

Fragile, handle with care

Indicates a medical device that can be

broken or damaged if not

handled carefully.

Caution Indicates the need for the user to

consult the instructions for use for

important cautionary information such

as warnings and precautions that

cannot, for a variety of reasons, be

presented on the medical device itself.

Consult instructions for use

Indicates the need for the user to

consult the instructions for use.

Batch code Indicates the manufacturer's batch

code so that the batch or lot can be

identified.

ISO 15223-1 Clause 5.1.7

Serial number Indicates the manufacturer's serial

number so that a specific medical

device can be identified.

ISO 15223-1 Clause 5.1.6

Catalogue number Indicates the manufacturer’s catalogue

number so that the medical device can

be identified.

Bravo Reflux Testing System 55 User Guide

ISO 15223-12, Clause 5.1.1

IEC 60601-1 Table D.1, Symbol 4

Directive 2012/19/EU, Annex IX

ASTM F2503

ISO 15223-1 Clause 5.3.4

ISO 15223-1 Clause 5.3.7

CAN/CSAC22.2 No.

60601-1

Manufacturer Indicates the medical device

manufacturer, as defined in EU

Directives 90/385/EEC, 93/42/EEC and

98/79/EC.

Direct current To indicate on the rating plate that the

equipment is suitable for direct current

only.

Separate collection for

Do not throw in trash. Dispose

according to local regulations. electrical and electronic equipment

Magnetic Resonance (MR)

Keep away from magnetic resonance

imaging (MRI) equipment. unsafe

Keep dry Indicates a medical device that needs

to be protected from

moisture.

Temperature limit Indicates the temperature limits to

which the medical device can be safely

exposed.

CSA certification Mark

Products bearing this mark have been

tested and certified in accordance with

applicable U.S. and Canadian electrical

safety

standards.

ISO 15223-1 Clause 5.1.4

ISO 15223-1 Clause 5.4.2

Use by date Indicates the date after which the

medical device is not to be used.

Do not re-use Indicates a medical device that is

intended for one use, or for use on a

single patient during a single

procedure.

IEC 60601-1 Table D.1,

Type BF applied

part

To identify a type BF applied part

complying with IEC 60601-1.

Symbol 19

Bravo Reflux Testing System 56 User Guide

IEC 60601-

1-2

Non-ionizing electromagnetic radiation

To indicate generally elevated,

potentially hazardous, levels of non-

ionizing radiation, or to

indicate equipment or systems e.g. in

the medical electrical area that include

RF transmitters or that intentionally

apply RF electromagnetic energy for

diagnosis or treatment.

IEC 60601-1 Table D2

ISO 15223-1 Sec 5

Refer to instruction manual or booklet

Humidity limitation Indicates the range of humidity to which

the medical device can be safely

exposed.

EN60529

Protection against fluid ingress: Dripproof

Indicates the IP rating of a device. The

values show the protection level against

environmental particulate and liquid

ingress respectively.

ISO 15223-1

Sec 5

Atmospheric pressure limitation

Indicates the range of atmospheric

pressure to which the medical device

can be safely exposed.

93/42/EEC, Medical Device Directive.

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling

and information to be supplied.

IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic

safety and essential performance.

Directive 2012/19/EU, Waste electrical and electronic equipment (WEEE).

ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety

in the Magnetic Resonance Environment.

CAN/CSA-C22.2 No. 60601-1 Medical Electrical Equipment - Part 1: General Require-

ments for basic safety and essential performance.

IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests.

EN 60529, Degrees of protection provided by enclosures (IP Code)

Bravo Reflux Testing System 57 User Guide

Medtronic FGS-0634 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual

Introduction

Description

Two Capsule Types

Indications for Use

Contraindications

Warnings and Precautions

Intended Use Environment

Storage

Electromagnetic Compatibility

Patient Information (Benefits and Risks)

System Components for Capsule–pH Calibration Not Required

System Components for Capsule–pH Calibration Required

System Workflow

Bravo pH Recorder

Description

Backlight

Patient Buttons

Clinician Buttons and Menus

Status LED

General Guidelines

Charging the Recorder

Turning the Recorder On and Off

Setting the Date and Time

Choosing Study Settings

Performing a Bravo pH Study without pH Calibration

Preparing the Delivery Device

Setting up the Vacuum

Starting Recording

Placing the Capsule

Stopping a pH Study

Performing a Bravo pH Study with pH Calibration

Calibrating Capsules

Existing Data

Starting Calibration

Setting up the Vacuum

Starting Recording

Placing the Capsule

Stopping a pH Study

Reviewing Instructions with Patients

Uploading pH Data

Recorder Maintenance

Safety and Technical Checks

Cleaning the Recorder

Cleaning the Case and Strap

Servicing the Battery

Troubleshooting

Delivery Device Disassembly Procedure

Recorder Troubleshooting

Appendix A: Technical Data

Bravo Recorder

Recorder Servicing

USB Cable

Charger

Battery

Essential Performance of Bravo Recorder

Electromagnetic Compatibility Declaration (EN / IEC 60601-1-2)

Bravo Capsule Specifications

Bravo Delivery Device Specifications

Appendix B: Symbols on Package Labeling