Bravo User Guide

Copyright This manual is the property of Given Imaging Limited and may not be transferred or reproduced in any form without the written permission of Given Imaging Limited. Copyright © 2011 Given Imaging Ltd.

Trademarks GIVEN, GIVEN & Design, PILLCAM, PILLCAM & Logo, PILLCAM IMAGING CAPSULE & Design, AGILE, RAPID, RAPID ACCESS, ORDERWIN, ORDER WHEN I NEED, FINGERS HOLDING A CAPSULE & Logo, FINGERS HOLDING PILLCAM CAPSULE & Logo, ICCE, ICCE Logos, and INTERNATIONAL CONFERENCE ON CAPSULE ENDOSCSOPY, VUESPAN, BRAVO PH SYSTEM, BRAVO, and ENDONETICS are Trademarks and/or Registered Trademarks of Given Imaging Ltd. its subsidiaries and/or affiliates in the United States and/or other countries. All other company or product names are the trademarks or registered trademarks of their respective holders. All rights not expressly granted are reserved.

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.

Table of Contents Introduction ... 2 Description ...2 Indications for Use ...2 Contraindications ...2 Warnings and Precautions ...2 Storage ...3 Electromagnetic Compatibility ...3 System Components ...4

Bravo pH Receiver ... 5 Description ...5 Patient Interface ...6 Clinician Interface ...6 General Guidelines ...8 Turning the Receiver On and Off ...8 Setting the Time and Date ...9 Setting Parameters for a pH Study ...10

Calibrating Capsules ... 13 Performing a Bravo pH Study ... 19 Vacuum Setup ...19 Receiver Setup ...20 Capsule Placement ...21 Confirm Monitoring ...26

Special Actions During a Study ... 26 Viewing the Status Parameters ...26 Stopping a pH Study ...27

Reviewing Instructions with Patients ... 27 Uploading pH Data ... 30 Receiver Maintenance ... 31 Safety and Technical Checks ...31 Cleaning the Receiver ...31 Cleaning the Carrying Case ...31 Replacing the Main Battery ...31

Troubleshooting ... 33 Delivery Device Disassembly Procedure ...33 Receiver Troubleshooting ...36

Technical Data ... 38 Bravo pH Receiver ...38 Datalink ...38 Service ...39 FCC Compliance Statement ...39 Declaration of Conformity ...39 Electromagnetic Compatibility Declaration (EN IEC 60601-122) ...39

Appendix: Bravo Capsule with Delivery Device Specifications ... 43 Capsule ...43 Delivery Device ...43

Explanation of symbols on package labeling Refer to the device to see which symbols apply to this product. Conformité Européenne (European Conformity). This symbol means that the device fully complies with MDD 93/42/EEC and R&TTE Directive 1999/5/EC. For USA audiences only Caution, consult accompanying documents Lot number Serial number Manufacturer address Fragile

Keep dry

Temperature limits

CSA mark

Expiration date Do not re-use FCC IEC 60601-1/EN60601-1, Type BF Equipment Product number Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations.

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Introduction

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 receiver (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 Bravo pH receiver for the duration of the study.

•

The data is then uploaded from the receiver to the software workstation. The software is intended to record, store, view, and analyze gastroesophageal pH data, enabling physicians to interpret study results.

Refer to the Bravo pH Capsule with Delivery Device insert sheet for indications, contraindications, warnings, and precautions. 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.

Indications for Use The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux. The Bravo pH capsule can be attached following either endoscopy or manometry.

Contraindications Patients with bleeding diathesis, strictures, severe esophagitis, varices, obstructions, pacemakers or implantable cardiac defibrillators are contraindicated.

Warnings and Precautions •

Bravo pH capsule with delivery device: Potential complications include, but are not limited to: • tears in the mucosal and submucosal layers of the esophagus causing bleeding and requiring possible medical intervention • perforation

•

gastrointestinal endoscopy: Potential complications include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, hypertension, respiratory arrest, cardiac arrhythmia or arrest

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Introduction • 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.

•

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) will result 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.

•

Patients are restricted from undergoing an MRI study within 30 days of the pH study.

•

Prior to the pH study, the patient should not eat or drink for a minimum of 6 hours.

Storage Store in a controlled room temperature environment at 15–45 °C (59–113 °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, refer to Electromagnetic Compatibility Declaration (EN IEC 60601-1-22) on page 39.

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Introduction

System Components The Bravo pH Monitoring System consists of the following items: •

Bravo pH receiver

•

receiver accessories: • cloth carrying case and shoulder strap • receiver Datalink (communication cradle) and adapter • serial-to-USB converter cable

•

RAPID pH and PolygramNet software (delivered either on media or preinstalled on a bundled PC workstation)

•

Bravo pH capsule with delivery device

•

calibration stand

•

vacuum pump

•

pH 1.07 and pH 7.01 calibration buffer solutions

•

sterile water (to be supplied by the user)

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Bravo pH Receiver

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2

10

3

1

4

8

pH 1.07

5

pH 7.01

7 6

Figure 1. System components

1

calibration stand

6

2

Bravo pH receiver

7

one AA/FR6 lithium battery buffer solutions

3

Bravo pH capsule with delivery device

8

software

4

capsule

9

receiver adapter

5

Datalink

10 carrying case

Bravo pH Receiver Description The Bravo pH receiver is lightweight and compact. It fits into a carrying case that comes with a strap and a belt clip allowing patients to carry it over the shoulder, attach it to a belt, or carry it in a pocket (without the carrying case). This flexibility allows the patient to carry the receiver throughout the study period.

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Bravo pH Receiver The receiver is designed with two separate interfaces: one for the patient and one for clinicians.

Patient Interface The patient interface is used by the patient to record symptoms during a pH study. 1 2

3

4

5

Figure 2. Patient interface.

1

Patient Display: Displays current time and optional pH readings.

2

Indicator Light: Illuminates for 3 seconds when symptom button is pressed.

3

Heartburn Button: Patient presses when experiencing heartburna.

4

Regurgitation Button: Patient presses when experiencing regurgitationa.

5

Chest Pain Button: Patient presses when experiencing chest paina.

a

This button can be programmed by the clinician for any symptom.

Clinician Interface The clinician interface is used by medical personnel to program the receiver for a pH study. This interface is hidden from patients by the front cover, which cannot be casually opened. This prevents patients from interfering with receiver settings during a study. To open the front cover: 1. Use a pen or paperclip to press the release (Figure 3). 2. Open the cover to access the receiver controls and display (Figure 4).

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Bravo pH Receiver

Front cover release Figure 3. Unlatching the receiver cover

Figure 4. Opening the receiver.

You can now access the clinician interface (Figure 5).

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Bravo pH Receiver

1

2 3

6

4 7

5

Figure 5. Clinician interface

1

Clinician Display: Provides the menu for programming receiver.

2

escape Button: Returns to previous screen.

3

Arrow Buttons: Moves through the menus to make selections when prompted.

4

enter Button: Confirm menu selections.

5

Button (power): Turns receiver On and Off when pressed for 2–3 seconds. While the receiver is on, the clinician display will shut down after several minutes to conserve power. Briefly pressing the power button restores the display.

6

Infrared Window: Enables communication between the receiver and computer, via Datalink.

7

Front Cover Release: Opens the front cover latch.

General Guidelines Follow these guidelines when working with the receiver: •

Always replace the battery at the start of a pH study. This reduces the risk of lost data during the study (refer to Replacing the Main Battery on page 31).

•

Always clean the receiver after each study (refer to Cleaning the Receiver on page 31).

•

Always turn off the receiver if it is not in use.

•

Each time the receiver is turned on, you must reset the time and date.

•

Set study parameters at the start of each study.

Turning the Receiver On and Off 1. Open the front cover (refer to Figure 3).

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Bravo pH Receiver 2. Press and hold the power button (2–3 seconds) until the receiver display appears. The receiver automatically performs an internal diagnostic check, which includes checking the batteries. • If the main and backup batteries are sufficiently charged, the receiver displays the time (refer to Setting the Time and Date on page 9). • If the main battery is low, this message appears on the receiver display: REPLACE MAIN BATTERY 3. To turn off the receiver, press and hold the power button until the receiver display disappears.

for 2–3 seconds

Setting the Time and Date After turning on the receiver, you are prompted to set the time and date. 1. Verify that the time is correct: 09:30:00 Correct? Yes No If the time is correct, press enter. and proceed to step 2. Otherwise, use the arrow buttons to move the cursor, select No, then press enter, and adjust the time. • Move the cursor to the hour, then use the up/down arrows to set the correct hour. • Repeat for minutes and seconds. • If the receiver is set for 12-hour time format, move the cursor to the AM/ PM display and set as needed. For information on selecting the time format (12-hr/24-hr) refer to Setting the Time Format on page 12. • When you are done, press enter. 2. Verify that the date is correct: Dec 1, 2009 Correct? Yes No

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Bravo pH Receiver If the date is correct, press enter. You are finished setting the time and date. The main menu appears. You can proceed to Setting Parameters for a pH Study on page 10. Setup pH Study

Cal Send

Main Menu

Otherwise, select No, press enter, and adjust the date. • Move the cursor to the month, then use the up/down arrows to set the correct month. • Repeat for day and year. • When you are done, press enter and proceed to Setting Parameters for a pH Study.

Setting Parameters for a pH Study You must set the study parameters before each study. This includes: •

Clearing old data from the receiver

•

Selecting the number of capsules to be used during a study (one or two)

•

Selecting the recording time

•

Setting the pH display to Off or On

•

Setting the symptom beep to Off or On

•

Choosing the time format on the display

•

Selecting the language of the interface

These are explained in detail below. Clearing Old Data from Receiver Before setting the study parameters for a new pH study, you are prompted to clear the data from the previous pH study. 1. If the receiver contains study data, a message appears asking if you want to clear the old data. Clear old data? Yes No (If this is the first study, or if the old data has already been cleared, this screen does not appear. Proceed to step 2.) • Note: If you are unsure of whether the data from the previous pH study was uploaded to the computer, move the cursor to No and press enter to return to the main menu. Upload the data to the computer (refer to Instruct the patient about what to expect when the Capsule detaches. on page 30), then proceed with clearing the data from the receiver. Bravo pH Monitoring System User Guide

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Bravo pH Receiver • If you are sure, select Yes then press enter to clear the old data. To confirm, move the cursor to Yes and press enter. Are you sure? Yes No This message is displayed as the receiver clears the data. Clearing data…

2. Move the cursor to select Setup from the main menu and press enter. Setup pH Study

Cal Send

Selecting the Number of Capsules After the data has been cleared, you are prompted to select the number of pH capsules for the study. 1. Move the cursor to select 1 for a one-capsule study and press enter. No. of Capsules 1 2 Note: Instructions regarding two-capsule studies are not included in this document. Contact Given Imaging if you require additional information. Selecting the Recording Time After selecting the number of capsules, you are prompted to set the recording duration. 1. Move the cursor to select the duration of the study and press enter. Recording Time 24hr 48hr Setting the pH Display After selecting the recording time, you are prompted to select whether the pH value appears on the patient display during the study. This does not affect the rest of the display (even if pH Display is set to Off, the time is still displayed on the patient display): 1. Move the cursor to select Off or On and press enter. pH Display Off On

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Bravo pH Receiver Setting the Symptom Beep After setting the pH display, you are prompted to determine whether the receiver emits a beep when the patient presses a symptom button. 1. Move the cursor to select Off or On and press enter. Button Beep Off On Setting the Time Format You are then prompted to choose between 12-hour (AM/PM) or 24-hour (military) time format. 1. Move the cursor to select 12hr or 24hr and press enter. Time Format 12hr 24hr Note: Whether you select the 12-hour or 24-hour option for the patient display, the software always uses 24-hour (military) time. Selecting the Language You are then prompted to select the language used in the clinician interface. 1. Move the cursor to select the desired language and press enter. Language English Note: The following languages are available: • English • Danish (Dansk) • Dutch (Nederlands) • Finnish (Suomi) • French (Français) • German (Deutsch) • Italian (Italiano) • Portuguese (Português) • Spanish (Español) • Swedish (Svenska) 2. Setup is complete. You are now ready to calibrate the capsule; proceed to Calibrating Capsules on page 13.

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Calibrating Capsules

Calibrating Capsules Calibration is necessary to ensure that the capsule is reading pH levels properly. To prepare for calibration: 1. Set up the calibration stand on a level surface and placing a clean calibration tube into each of the four holders. 2. Check the expiration date on the buffer fluid bottles (next to

on the label)

3. Fill the 4 tubes in the calibration stand half full. The fluid should be barely visible above the calibration stand tube holder. • Tube 1: pH 7.01 buffer • Tube 2: Sterile water • Tube 3: pH 1.07 buffer solution • Tube 4: Sterile water Use buffer solutions at room temperature (20–25 °C, 68–77 °F) for each calibration procedure. 4. Check the expiration date on the capsule (next to

on the label).

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

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

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Calibrating Capsules

To open the plastic cover To remove magnetic clip To remove soaker bulb

Figure 7. Remove Bravo pH capsule shipping components.

Note: When the magnetic clip is removed, the capsule automatically turns on. 7. Check soaker bulb for fluid and set aside. If bulb is dry, contact Given Imaging Customer Support. 8. After opening the capsule package, ensure that the capsule trocar needle has not advanced (Figure 8). •

Trocar needle

Suction chamber

Figure 8. Ensure that the trocar needle has not advanced

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Calibrating Capsules 9. Without bending or kinking the delivery device, place the delivery device handle into the calibration stand (Figure 9).

Calibration tube

delivery device

Calibration stand capsule fill level

ID number tag

delivery device handle receiver

Figure 9. delivery device and receiver in calibration stand.

10. Carefully place the capsule into the pH 7.01 buffer solution calibration tube. Caution: When placing the capsule into the calibration tube, do not allow either part of the pH sensor (i.e., short, silver-colored antimony and long, clear reference sensor) to catch on the edge of the calibration tube. Stay clear of the tube edge, and carefully lower the capsule into the solution. Damage to the antimony or reference sensor can occur if it catches on the tube edge. Any damage to the pH sensor will require the delivery device to be discarded before use. 11. Ensure that the capsule is completely covered in with the buffer solution. Gently agitate the capsule to remove any air bubbles. 12. Allow the capsule to remain submerged for at least 10 minutes prior to calibration. 13. Unlatch and open the receiver cover. Turn the receiver on and place it on the calibration stand (Figure 9): • For a receiver with the attached belt clip, set the receiver into the molded recess in the calibration stand base.

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Calibrating Capsules • For a receiver without the belt clip, first place the receiver adapter into the molded recess in the calibration stand base, then place the receiver into the adapter. 14. Move the cursor to select Cal from the main menu, then press enter. This message appears: Cal Capsule 1 Yes No

15. Select Yes, then press enter. This message appears: Listening for Capsule 1:

Notes: • Ensure that the capsule is completely covered with pH 7.01 buffer solution. • Do not move the calibration stand during this process. • Do not move the capsule while it is in the buffer solution after you have initially agitated it to remove any air bubbles. The receiver identifies the pH capsule and displays the ID number for the capsule. Note: If the receiver does not identify the capsule, refer to Troubleshooting on page 33. 16. Confirm that the capsule ID number (for example, 2144) on the receiver display is the same as the number printed on the delivery capsule ID tag (Figure 10). receiver display

delivery capsule ID tag number

Figure 10. Match the ID number with the Bravo pH receiver display.

• If the ID numbers match, move the cursor to Yes and press enter.

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