Your Reflux Band; Indication For Use; Contraindication For Use; Important Information - Somna Therapeutics Reflux Band Manual De Instrucciones

1.

YOUR REFLUX BAND

Introduction
™
The Reflux Band is designed to reduce symptoms of acid reflux into your throat or lungs, also known as
Throatburn or Laryngopharyngeal Reflux (LPR). Typically worn while sleeping, the Reflux Band applies slight
external pressure to a ring of muscle at the top of your esophagus called the Upper Esophageal Sphincter (UES).
This pressure helps prevent he flow of stomach contents past the esophagus into the throat and lungs.
Benefits
When used as indicated, the Reflux Band has been proven to reduce reflux symptoms. Clinical studies have
shown that people using the Reflux Band saw symptom improvement within the first two weeks of use, with
continued symptom improvement for three months.
What are the symptoms of LPR?
Typical LPR symptoms include hoarseness, persistent cough or throat clearing, postnasal drip, sore throat,
difficulty swallowing, sensation of a lump in the throat and sleep disruption. Sometimes reflux can make other
conditions worse such as pneumonia, bronchitis, asthma, sinusitis and COPD.
2.

INDICATION FOR USE

The Reflux Band is indicated for people 18 years and older to reduce the symptoms of laryngopharyngeal reflux
(LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal
sphincter. The device is worn by users when sleeping.
3.

CONTRAINDICATION FOR USE

DO NOT use the Reflux Band if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic
or electronic devices. Such use could cause programming of these devices to be altered or shut off, electric
shock, burns, electrical interference, or death.
4.

IMPORTANT INFORMATION

Warnings
•
Consult your doctor prior to using any OTC treatment for LPR if you are a current or former smoker, are
spitting up blood or are losing weight as these may be symptoms of an upper aero-digestive system
malignancy.
•
The safety and effectiveness has not been shown for the following conditions. Talk to your doctor before using
the Reflux Band if you have any of these conditions.
 High ocular pressure (glaucoma).
 Malignancy of the neck, including neck surgery.
 An altered mental status due to the use of s edative drugs or narcotics.
 Carotid artery disease, thyroid disease, a history of cerebrovascular disease or any disorder of connective
tissues (e.g., Marfan's Syndrome or Ehlhers-Danlos Syndrome).
 Under the age of 18 years old.
•
Modification of this equipment may be unsafe and is strictly prohibited.
•
The use of accessories, detachable parts and materials not described in the instructions for use may be
unsafe and is strictly prohibited.
•
Please report to www.refluxband.com if any unexpected operations or events occur.
•
The Reflux Band is designed and packaged for use by one person only. The user is the intended operator of
the Reflux Band and can measure and maintain the device and its accessories under normal circumstances
according to the instructions in this User Manual.
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