Important Safety Information

Bravo pH Monitoring System

Indications for Use
Bravo pH Monitoring System 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.

Contraindications
Patients with a history of bleeding diathesis, strictures, severe esophagitis, varices, obstructions, pacemakers or implantable cardiac defibrillators

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 discomfort and nasopharyngeal damage resulting in bleeding and soft tissue damage. Potential complications associated with the Bravo System include perforations or tears in the mucosal or submucosal layers of the esophagus causing bleeding and requiring possible medical intervention, 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 safety and efficacy of the Bravo pH capsule with delivery system has not been established for pediatric use. 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 and possible patient injury.

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.

The pH Testing System is intended to record, store, view, and analyze gastro esophageal and pH data.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

NOTE: For a complete listing of indications, contraindications, warnings, and precautions, please refer to pH Testing Application User Guide or the Bravo pH Capsule with Deliver Device Instructions for Use.

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