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Safety Information
Indication 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.
Bravo is available by prescription only. The Bravo procedure is
not for everyone. Talk to your doctor to see if Bravo is right
for you.
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