Table of Contents
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Table of Contents
Troubleshooting
Related Manuals for Given Imaging Bravo
Summary of Contents for Given Imaging Bravo
- Page 1 Bravo pH Monitoring System ® User Guide DOC-2033-07 March 2016...
- Page 2 Copyright & Trademarks Copyright © 2001–2016 Given Imaging Ltd. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
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Page 3: Table Of Contents
Choosing Study Settings ..............11 Calibrating Capsules ..................13 Existing Data ..................13 Starting Calibration ................13 Performing a Bravo pH Study ................19 Setting up the Vacuum ................. 19 Starting Recording ................20 Placing the Capsule ................21 Stopping a pH Study ................25 Reviewing Instructions with Patients ........... - Page 4 Battery ....................36 FCC Compliance Statement ..............36 Declaration of Conformity ..............36 Essential Performance of Bravo Recorder ........... 36 Electromagnetic Compatibility Declaration (EN / IEC 60601-1-2) ..37 Bravo pH Capsule Specifications ............41 Bravo pH Delivery Device Specifications ........... 41 Appendix B: Symbols on Package Labeling ............
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Page 5: Introduction
The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux: First, a Bravo pH capsule is calibrated and the Bravo pH recorder (an ambulatory, • programmable data recorder) is prepared. Using the delivery device, the capsule is positioned and attached in the patient’s •... -
Page 6: Warnings And Precautions
• 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 •... -
Page 7: Storage
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. -
Page 8: Patient Information (Benefits And Risks)
Risks The Bravo pH test is not for everyone. If you have bleeding diathesis, strictures, severe esophagitis, varices, obstructions, a pacemaker, or an implantable cardiac defibrillator, you should not undergo a Bravo pH test. Additionally, because the capsule contains a small magnet, you should not have an MRI study within 30 days of undergoing the Bravo pH test. -
Page 9: System Components
AccuView or Reflux software, delivered separately either on media or pre-installed on a bundled PC workstation (referred to as PC in this user guide) Bravo pH capsule with delivery device (referred to as capsule in this user guide) vacuum pump pH 1.07 and pH 7.01 calibration buffer solutions... -
Page 10: System Workflow
You must also become familiar with the basic workings of the recorder, including normal maintenance functions such as recharging and cleaning. See Bravo pH Recorder on page 7 and Recorder Maintenance on page 29. -
Page 11: Bravo Ph Recorder
Bravo pH Recorder Description The Bravo pH recorder is lightweight and compact. It on/off button fits into a case that comes with a strap and a belt clip. case Patients wear the recorder (over the shoulder or attached to a belt) LCD screen throughout the study period. -
Page 12: Clinician Buttons And Menus
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. Bravo pH Monitoring System User Guide... -
Page 13: Status Led
When working with the recorder: All values in (for example, study duration, number of capsules) and • Settings (for example, date and time format and interface language) stay in Preferences effect for all studies until you change them. Bravo pH Monitoring System User Guide... -
Page 14: Charging The Recorder
(default 30 seconds; see Choosing Study Settings on page 11). Press any key to turn it back on. If you are not sure if the recorder is turned on, press the on/off button once. Bravo pH Monitoring System User Guide... -
Page 15: Setting The Date And Time
Enter b. Use to select the study duration (24, 48, or 96 hours). Note ֠ The 96-hour option is only available if you are using AccuView or Reflux software as your PC software application. Bravo pH Monitoring System User Guide... - Page 16 To return one level up in the menu tree, press Note Once you have set preferences, you will not need to reset them ֠ unless: • you want to change something, or • the recorder battery is fully discharged. Bravo pH Monitoring System User Guide...
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Page 17: Calibrating Capsules
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). Bravo pH Monitoring System User Guide... - Page 18 Check the expiration date on the capsule (next to on the label). 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 4).
- Page 19 Open the plastic cover. Remove magnetic clip. Remove soaker bulb. Figure 5. Remove Bravo pH capsule shipping components. 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.
- Page 20 (Figure 7). calibration tube delivery device handle Figure 7. Delivery device in calibration stand. Carefully place the capsule into the pH 7.01 buffer solution calibration tube as indicated on the recorder screen. Bravo pH Monitoring System User Guide...
- Page 21 Rinse the capsule in sterile water. Press . This message appears: Next Place capsule #1 in pH 1.07 and press Start to calibrate. Place the capsule in the pH 1.07 solution and press Start Bravo pH Monitoring System User Guide...
- Page 22 After the first capsule is calibrated, it can remain outside the buffer solutions for up to 60 minutes before use. Proceed to Performing a Bravo pH Study on page 19. Note ֠...
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Page 23: Performing A Bravo Ph Study
Performing a Bravo pH Study 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. Setting up the Vacuum Make sure that the vacuum flow knob is turned to maximum. -
Page 24: Starting Recording
Note ֠ The recorder screen shuts off after 60 seconds to conserve battery power. To turn on the recorder screen during a study, press any button. Proceed to Placing the Capsule on page 21. Bravo pH Monitoring System User Guide... -
Page 25: Placing The Capsule
Placing the Capsule Oral placement of the Bravo capsule can be performed either using: a. endoscopy: using an endoscope, determine the desired location for the capsule in the esophagus. Typically, the capsule is placed 6 cm (2.4 inches) above the squamo-columnar junction. - Page 26 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.
- Page 27 (Figure 12). Rotate the plunger clockwise until the white line on the plunger lines up with the white upward arrow. Figure 11. Release the capsule from the delivery device. Bravo pH Monitoring System User Guide...
- Page 28 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. Bravo pH Monitoring System User Guide...
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Page 29: Stopping A Ph Study
, this message is displayed: Last study data not uploaded! To upload, connect recorder to PC. Remember: if you stop the study, you must upload the data to unlock the recorder before you can continue. Bravo pH Monitoring System User Guide... -
Page 30: Reviewing Instructions With Patients
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. Instruct the patient to make sure that the recorder is always monitoring the capsule: Bravo pH Monitoring System User Guide... - Page 31 Instead, it is recommended to use the belt clip for children. Instruct the patient about what to expect when the capsule detaches. Instruct the patient to return the recorder at the completion of the study. Bravo pH Monitoring System User Guide...
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Page 32: Uploading Ph Data
USB and reconnect it again between uploads. The Bravo recorder supports both AccuView and Reflux software. Connect the Bravo recorder to your PC using the supplied USB cable. Open AccuView or Reflux software by double-clicking the AccuView or Reflux software icon on your desktop. -
Page 33: Recorder Maintenance
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 pH Monitoring System User Guide... -
Page 34: Troubleshooting
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. - Page 35 This will release the capsule at distal end. When the capsule releases from the delivery device, remove the delivery device from the patient. If possible, use an endoscope to confirm that the capsule remained attached to the esophageal tissue. Bravo pH Monitoring System User Guide...
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Page 36: Recorder Troubleshooting
Difference in mV between If error persists, contact signals read by capsule during customer support. calibration is greater than expected. Error 4: Signal unstable Recorder cannot detect stable signal from capsule within 60 seconds during calibration. Bravo pH Monitoring System User Guide... - Page 37 USB cable until this icon is no longer displayed, indicating that data transfer has finished). Data upload fails. Communication error. Disconnect the recorder from the USB cable and then reconnect it. Bravo pH Monitoring System User Guide...
- Page 38 Patient display shows Hi (H) pH level momentarily out-of- Continue with study (no action range (too high). required). Patient display shows Lo (L) pH level momentarily out-of- Continue with study (no action range (too low). required). Bravo pH Monitoring System User Guide...
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Page 39: Appendix A: Technical Data
Water Ingress Protection: Ordinary Capsule Transmission Duty Cycle: Every 12 seconds 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. Bravo pH Monitoring System User Guide... -
Page 40: Usb Cable
• cause undesired operation. Declaration of Conformity Given Imaging declares that this product is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 93/42/EEC as amended by 2007/47/EC on Medical Devices. For additional information, contact Given Imaging. -
Page 41: Electromagnetic Compatibility Declaration (En / Iec 60601-1-2)
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. - Page 42 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 Compliance Electromagnetic environment –...
- Page 43 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 Compliance Electromagnetic environment –...
- Page 44 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.
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Page 45: Bravo Ph Capsule Specifications
Storage & Operation Operation temp. 20–45°C (68–113 °F) Storage humidity Up to 85% Operation humidity Storage & operation 508–635 mmHg pressure Bravo pH Delivery Device Specifications Proboscis & Boot Aliphatic, polyether-based TPU Materials Nest Acrylonitrile Butadiene Styrene Foam Polyethelyne (PE) Tube... -
Page 46: Appendix B: Symbols On Package Labeling
Direct current Product number Do not dispose of this product Non-ionizing radiation (from in the unsorted municipal wireless transmission) waste stream. Dispose of this product according to local regulations. Bravo pH capsules are MR unsafe Bravo pH Monitoring System User Guide...
Need help?
Do you have a question about the Bravo and is the answer not in the manual?
Questions and answers
Will the recorder give an initial PH if it is not attached to the esophagus or let's say connected to the wrong capsule number
No, the Given Imaging Bravo recorder will not provide an initial pH reading if the capsule is not in contact with a solution or if the recorder is connected to the wrong capsule number. The recorder may display errors such as "Capsule out-of-range" or "Capsule ID mismatch," requiring corrective actions like moving the recorder closer or recalibrating the capsule.
This answer is automatically generated
How do I take the unit through the airport screening process? Can it go through the xray machine?
My 96 hrs is up but recorder is still on, should I shut it off manually?