The Filtered Mouthpiece Kit helps ensure safe and effective respiratory treatments and is the ideal companion for the AEROECLIPSE® BAN™ Nebulizer.
The filter kit with the AEROECLIPSE® BAN™ Nebulizer – where safety and efficiency meet seamlessly.
BEFORE EACH USE
Replace immediately if your filter has become damaged or has missing parts.
These are shortened user instructions. Always review the complete instructions that came with your device.
On Inhalation
On Exhalation
510(k) clearance validates that a device (or combination of two devices) is safe and effective for its intended use. This is required to ensure that performance of the nebulizer is not impacted with the addition of the filtered mouthpiece kit – for both aerosol delivery and exhalation resistance.
No, this is for mouthpiece delivery only. Aerosol masks have openings that would allow emissions to escape into the room even with a filter inline (negating the benefit of adding in a filter).
The Filter Kit is a single patient, disposable device – the mouthpiece is approved for 7 days with single use replacement filters.
It is important to note that this filter can be used for many purposes other than aerosol delivery and thus the above wording is necessary. Following the hospital/organizational guidelines for filter replacement when used with nebulizer therapy is acceptable. Filters that are damaged or saturated should be changed out as soon as possible to avoid potential problems.
The filter has been tested to filter viral particles to 99.997% and bacterial particles to 99.9997%.
The bacterial and viral filtration efficiency performance of the filtration media has been tested by the material’s manufacturer. Report available upon request.
It is important to note that filters have different ratings for efficiency and the particle sizes that they can filter. Not every filter will function the same even if they look similar. (see the following question/answer: Can any filter be used on the mouthpiece kit?).
No, the filter assembly is a single use device and is a sealed unit-not intended to be taken apart.
Replacements filters can be ordered separately.
The filtered mouthpiece is 510(k) cleared for use with the AEROECLIPSE® BAN™ Nebulizer, but also has standard ISO fittings in which a variety of filters could be used. It is important that a replacement filter have the same specifications as the current Monaghan filter at filtering out the viral and bacterial particles to insure similar functionality. Many filters are on the market and may have different efficiency percentages/ratings (or how much particle and the size they can filter).
Saturated filters should be changed out immediately or as soon as possible to insure the same high percentage of viral and bacterial filtering. Not only could this have the potential to increase the resistance in the system, the filtering capacity is greatly reduced when the filter media becomes wet or has condensate depositing on the surface. Humidity is OK, but if droplets or pools of moisture are forming on either side of the filter media it should be changed out as soon as possible.
Yes, but you may increase the resistance in the system making it more difficult for the patient to exhale through the nebulizer and filter system. The patient should be monitored closely if using the two filters together for increasing work of breathing and fatigue.
Due to the design of this mouthpiece filter kit, it may be difficult to adapt to other nebulizers.
Yes. Please review the Clinical Evidence section below. Should you have any questions about the data, please contact your Territory Manager.
If you have a question that was not answered here, please contact us.
References
“There’s funny little ways that it’s made a difference. I was coughing so hard and there was so much pressure in my lungs that I had to sleep sitting up. It was hard to go out walking my dog for example because I was so breathless. So I really find the device helps to clear my lungs, I’ve been able to lie down at night so that just in itself it is a very good thing because it’s better rest.”
“It means better health, it means I feel better. It also helps to just clear my airways in everyday situations if I want to go out to a show which can be hard to do when you’re a cougher. I use this a lot before I go to clear my airways so I don’t have to run into that problem when I’m out.”
“The Aerobika* OPEP device has proven to be more easy [sic] to use and monitor. We struggle to get my daughter to perform her chest therapy using the traditional [competitive] device. This has proven to be more effective.”
“I have had chronic cough for 5 years now. After just two uses I slept through the night without coughing several times during the night. I normally had severe long cough spells at least once a week…”
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