Br
avo pH Monitoring System 2 User Guide
chapter.fm 3/21/16 4:05 pm
5.5 x 7.75 inches (140 mm x 197 mm)
Warnings and Precautions
•
Bravo pH capsule with delivery device: Potential complications include, but are
not limited to:
• aspiration of the capsule if inadvertently pulled back up into the upper
esophagus by the delivery device. There is a possibility that this may occur in a
procedure in which the capsule did not attach to the esophageal mucosa.
• tears or perforations in the mucosal and submucosal layers of the esophagus
causing bleeding and requiring possible medical intervention.
• gastrointestinal endoscopy: Potential complications include, but are not
limited to: perforation, hemorrhage, aspiration, fever, infection, hypertension,
respiratory arrest, and cardiac arrhythmia or arrest.
• nasal intubation: Potential complications include, but are not limited to: sore
throat, discomfort, and nasopharyngeal damage resulting in bleeding and soft
tissue damage.
•
Bravo pH capsule: Potential complications include, but are not limited to:
• discomfort associated with the capsule, or failure to detach from the esophagus
within several days after placement, either of which may necessitate endoscopic
removal.
• premature detachment of the capsule.
•
The safety and efficacy of the Bravo pH capsule with delivery device has not been
established for pediatric use on patients below the age of 4.
•
The Bravo pH capsule with delivery device is a single-use, disposable device. Reuse
or any other misuse of a Bravo pH capsule with delivery device (such as sharp
bending or kinking) results in an increased potential for damage to the delivery
device and capsule, and possible patient injury.
•
Prior to use, all equipment for the pH study should be examined carefully to verify
proper function.
•
Unauthorized maintenance by inadequately trained personnel would result in an
unacceptable risk (e.g., excessive temperatures, fire, or explosion).
•
A thorough understanding of the technical principles, clinical applications and risks
associated with the Bravo recorder is necessary before using this product. Read the
entire manual before using the system for the first time.
•
No modification of this equipment is allowed.
•
Patients are restricted from undergoing an MRI study within 30 days of the pH
study.
•
The Bravo capsule contains a trocar needle that is made of stainless steel. Use
caution in patients with known sensitivities or allergies to the metals that are
contained including chromium, nickel, copper, cobalt, and iron. The Bravo pH test
lasts from 48 to 96 hours.
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