Reflux testing systems

Bravo™ calibration-free reflux testing system

<p>The Bravo™ calibration-free reflux testing system is a capsule-based testing system used to determine if acid reflux is causing the patient's symptoms.</p>

Ordering information

Contact a representative

Indications, Safety, and WarningsIndications for useThe Bravo™ monitoring system is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from four 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.ContraindicationsPatients with bleeding diathesis, strictures, severe esophagitis, varices, obstructions, pacemakers, or implantable cardiac defibrillators are contraindicated.Warnings and precautionsPatients 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.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 four.

The Bravo™ pH capsule with delivery device is a single-use, disposable device. Reuse or any other misuse of a Bravo™ pH capsule with delivery device (such as sharp bending or kinking) results in an increased potential for damage to the delivery device and capsule, and possible patient injury.

Prior to use, all equipment for the pH study should be examined carefully to verify proper function.

Unauthorized maintenance by inadequately trained personnel would result in an unacceptable risk (e.g., excessive temperatures, fire, or explosion).

A thorough understanding of the technical principles, clinical applications and risks associated with the Bravo™ recorder is necessary before using this product. Read the entire manual before using the system for the first time.

No modification of this equipment is allowed.

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

The Bravo™ capsule contains a trocar needle that is made of stainless steel. Use caution in patients with known sensitivities or allergies to the metals that are contained, including chromium, nickel, copper, cobalt, and iron. Tests last from 48 to 96 hours.

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

If excretion of the Bravo™ pH capsule from the patient has not been positively verified, and the patient develops unexplained post-procedure 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.

Features

Discover the Bravo™ calibration-free reflux testing system.

Bravo™ calibration-free reflux capsule

Use the Bravo™ calibration-free reflux testing system for gastroesophageal pH measurement and monitoring of gastric reflux. The capsule can be attached following either endoscopy or manometry and doesn't require pH calibration.

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:

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 four.

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).

No modification of this equipment is allowed.

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 six hours.

Bravo™ reflux recorder

The patient wears the recorder, for up to 96 hours while the capsule is detecting reflux events, to record reflux data and patient activity.

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:

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 four.

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).

No modification of this equipment is allowed.

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 six hours.

Reflux software v6.1

Our reflux software supports the upload and analysis of pH and pH-impedance data collected from the Bravo™ reflux recorder and the Digitrapper™ reflux recorder. The reflux software also allows for extended recording times up to 96 hours⁵ via the Bravo™ calibration-free reflux testing system.

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:

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 four.

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).

No modification of this equipment is allowed.

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 six hours.

Download software

1 in 3 patients referred with ongoing symptoms while using PPIs doesn't have GERD.⁵

There are many recent advances in the diagnosis and management of GERD. Prolonged wireless pH monitoring has value on clinical reflux monitoring to enable the assessment of predominant exposure patterns and aid in the diagnosis of GERD.¹

Learn more about the benefits of 96-hour reflux monitoring. View clinical summary.
See the current GERD diagnosis and management guidelines from the American College of Gastroenterology and the American Gastroenterology Association.

Smiling African American woman stretching on beach brandcentralphotos September22

Among patients with heartburn, endoscopy with ambulatory reflux monitoring (off PPI) optimizes cost-effective management.⁶

The most cost-effective diagnostic approach to managing patients with typical GERD symptoms of heartburn that lack alarm symptoms and fail an empiric PPI is to offer endoscopy with ambulatory reflux monitoring followed by a trial of PPI discontinuation for patients without erosive findings.⁶

See the current GERD diagnosis and management guidelines from the American College of Gastroenterology and the American Gastroenterology Association.

Bravo™ calibration-free is the capsule-based pH reflux testing system that can be used to determine if acid reflux is causing the patient's symptoms.

Featured education

GERD and esophageal motility disorders

Advance your understanding of GERD and esophageal motility disorders including diagnostic workup and subsequent treatment considerations.

See webinar (open in new window)

Bravo™ reflux testing: a clinical story

Get a high-level overview of esophageal reflux testing modalities.

Watch presentation (open in new window)

Reflux software v6.1

Download the latest Bravo™ reflux reader software.

Download software

Ordering information

Item number	Description	Units per box
FGS-0635	Bravo™ calibration-free reflux capsule with delivery system	5
FGS-0634	Bravo™ reflux recorder (includes carry case, charger, carry strap, USB cable, document mini CD)	1
409990126	Reflux software v6.1 kit	1

Resources

Diagnostic Testing for GERD and Motility Disorders with Endoflip™ and Bravo™ Systems Brochure (open in new window)

View this brochure to learn about two simple tests using the Endoflip™ impedance planimetry system and the Bravo™ calibration-free reflux testing system that can provide therapeutic direction for diagnosing GERD and motility disorders.

PRODUCT PDF 702 KB

Esophageal Portfolio Product Cleaning Guide (open in new window)

View a quick reference guide for cleaning esophageal portfolio products, including Barrx™ flex RFA energy generator, Bravo™ reflux recorder, Digitrapper™ reflux recorder, Endoflip™ impedance planimetry system, Manoscan™ ESO HRM catheter, and SmartPill™ motility recorder and cradle.

PRODUCT PDF 1 MB