Reflux testing systems

Bravo™ calibration-free reflux testing system

<p>With up to a 96-hour monitoring period, the Bravo™ reflux testing system increases the likelihood of detecting reflux events with improved symptom association determination.<sup>1</sup></p>

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Indications, Safety, and WarningsThe material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).Please note that the intended use of a product may vary depending on geographical approvals.See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.Medtronic products placed on European markets comply with EU and UK legislation (if applicable) on medical devices. For any further information, contact your local Medtronic representative.Medtronic medical devices marketed in Spain are in compliance with the Spanish legislation in force.

Features

Discover the Bravo™ calibration-free reflux testing system.

Bravo™ calibration-free reflux capsule

The Bravo™ calibration-free reflux capsule is ready for placement at the time of a negative endoscopy without disrupting your workflow. Simply activate, pair with the recorder, place in patient, and start assessing acid reflux.

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.

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 Digitrapper™ reflux recorder and the Bravo™ reflux recorder. The reflux software also allows for extended recording times up to 96 hours via the Bravo™ 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.

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
FGS-0656	Reflux software v6.1 kit	1

Resources

European Esophageal Product Family brochure,EMEA-SE-2100161 - 21-weu-esophageal-product-family-brochure-5632155, EMEA‑SE‑2100161-esophageal-product-family-brochure-en-we-8899883

Esophageal product family brochure (open in new window)

View a sales tool brochure for healthcare professionals presenting the esophageal and gastric portfolio with new messages regarding transforming esophageal care and endoscopy.

PRODUCT PDF 2 MB

Bravo™ calibration-free reflux testing system

Features

Discover the Bravo™ calibration-free reflux testing system.

Bravo™ calibration-free reflux capsule

Bravo™ reflux recorder

Reflux software v6.1

Ordering information

Resources

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