Bravo pH Monitoring System 1 User Guide
chapter.fm 3/21/16 4:05 pm
5.5 x 7.75 inches (140 mm x 197 mm)
Introduction
Description
The Bravo
®
pH Monitoring System is intended to be used for gastroesophageal
pH measurement and monitoring of gastric reflux:
•
First, a Bravo pH capsule is calibrated and the Bravo pH recorder (an ambulatory,
programmable data recorder) is prepared.
•
Using the delivery device, the capsule is positioned and attached in the patient’s
esophagus, following either endoscopy or manometry.
•
The data is collected by the capsule and transmitted to the recorder for the duration
of the study.
•
The data is then uploaded from the recorder to the software application on the PC or
workstation. The software application is used to record, store, view, and analyze
gastroesophageal pH data, enabling physicians to interpret study results.
Indications for Use
The Bravo pH Monitoring System is intended to be used for gastroesophageal pH
measurement and monitoring of gastric reflux in adults and children from 4 years of age.
The Bravo pH capsule can be attached following either endoscopy or manometry. The
AccuView and Reflux software applications are intended to record, store, view, and
analyze gastroesophageal pH data.
Contraindications
Patients with bleeding diathesis, strictures, severe esophagitis, varices, obstructions,
pacemakers or implantable cardiac defibrillators are contraindicated.
Warning
Patients are restricted from undergoing an MRI study for 30 days from
the start of a pH study. The Bravo pH Monitoring System is not
compatible for use in an MRI magnetic field. Use of the Bravo pH
Monitoring System in an MRI magnetic field will result in damage to the
system and possible patient injury.
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