Descriptive sheet Otovent
Description
Nasal balloon device for autoinflation of the Eustachian tube, in order to compensate for negative pressure in the middle ear.
It consists of two parts, a latex balloon and a polypropylene nasal cannula, which must be connected before use.
It can be used by adults and children aged 3 years and older. Children should always be treated under adult supervision.
Non-sterile and reusable device.
Intended for use by one person only.
How to use
For otitis media with effusion (serous). During the first week of treatment, it should be used at least 3 times a day (morning, noon, and evening), inflating each nostril on each occasion. After one week, Otovent should be used at least twice a day (morning and evening). Treatment may continue for more than a month, and the maximum clinical effect may take several months. Consult your doctor after 2-3 weeks to decide whether treatment should be continued.
For symptom relief after a flight, diving, or hyperbaric chamber treatment. For in-flight use, Otovent should be used 3-4 times as soon as the descent begins. If symptoms persist, treatment can be continued after landing. Otovent can be used several times before/after a dive or during/after hyperbaric chamber treatment to relieve symptoms.
Warnings
Balloons contain latex. If you are allergic to latex or products containing latex, consult your doctor before using this product.
If allergic symptoms appear, such as skin rash, itching, difficulty breathing, or swelling, stop treatment and consult your doctor.
Choking Hazard: Product contains small parts. Keep out of reach of children.
Treatment of children should always take place under the supervision of an adult.
Never use toy balloons for Otovent treatment. Only replacement Otovent Balloons should be used with the CE-marked Otovent autoinflation medical device.
If you suffer from frequent, minor nosebleeds, any manipulation of the nose (for example, picking, blowing, or inflating a balloon) can cause a hemorrhage. This condition is uncomfortable but generally harmless.
If you have had sinus surgery, consult your doctor before using Otovent. Using Otovente after sinus surgery may increase the risk of pneumocephalus.
If you experience perforation of the eardrum, severe headache or dizziness, sensitivity to light, and/or nausea while using Otovent, stop treatment and consult your doctor.
Some patients may experience ear discomfort during inflation. This initial sensation will subside with subsequent inflation and is an indication that the procedure is working properly.
Conservation
Shelf life in intact packaging: 36 months.
Format
Pack of 5 balloons + 1 cannula