BRAVO pH MONITORING SYSTEM

Indications for Use
Bravo pH Monitoring System (Medtronic, Inc.) with accessories is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux. The pH probe (capsule) can be delivered and placed endoscopically or with standard manometric procedures. The pH Software Analysis Program is intended to record, store, view and analyze gastroesophageal pH data.

Warnings and Precautions
Potential complications associated with gastrointestinal endoscopy include but are not limited to: perforation, hemorrhage, aspiration, fever, infection, hypertension, respiratory arrest, cardiac arrhythmia or arrest. Potential complications associated with nasal intubation include but are not limited to: sore throat, trauma to nasopharynx or bloody nose. Complications associated with the Bravo System include premature detachment of the capsule, failure of the capsule to slough off in a timely period, or discomfort associated with the capsule requiring endoscopic removal.

The Bravo pH Capsule with Delivery System is a single use, disposable device. Reuse or any other misuse of a Bravo pH Capsule with Delivery System will result in an increased potential for damage to the device and ancillary equipment.

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

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

Prior to the Bravo procedure, the patient should be NPO (not eating or drinking) for a minimum of 6 hours.

[MR healthcare professionals are advised to contact the respective manufacturer to ensure that the latest safety information is obtained and carefully followed in order to ensure patient safety relative to the use of an MR procedure.]

REFERENCE
http://www.medtronic.com/physician/gastro/disclosure.html