FGS-0684

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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.

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Customer Care Team