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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 RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.

The Bravo pH Monitoring System™ and Accessories is an ambulatory esophageal pH testing device. The Bravo system is a simple, minimally invasive outpatient procedure that involves the placement of a pH telemetry Capsule against the mucosal wall of the esophagus that simultaneously measures pH and transmits the data to a receiver attached to the patient's waist. The Bravo pH Monitoring System™ and Accessories consists of four main components: Bravo pH Capsule with Delivery System, Bravo pH Receiver, RAPID pH and PolygramNet software, and Bravo pH Delivery System Accessories.

Used to measure intragastric and intraesophageal pH (hydrogen ion concentration) in pediatric patients

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The pH Analysis Module is a software program that has been designed to analyze intragastroesophageal pH data recorded from the gastrointestinal tract in pediatric and adult populations. The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.

The Polygram Software for Windows (K946322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters include min and max values, length of selection. By adding the pH Analysis Module to the Polygram Software for Windows, the user can also have all the intragastroesophageal pH data analyzed (data recorded from the gastrointestinal tract in pediatric and adult population). The analysis report includes sections such as patient demographics; intepretation and comment (for user to insert); procedure summary; pH tracing; period table including number such as duration of recording, number of periods of interest, time where pH was below certain threshold value, symptom correlation, scoring; physician signature section. The analysis report can then serve as a part of the physician's diagnosis and post treatment evaluation.