AEROECLIPSE* XL BAN* Nebulizer

A nebulizer is a medical device designed to work with a compressed air source to convert liquid medication into a fine mist so it can be inhaled directly into the lungs. You may need nebulizer treatments if you have lung disease such as cystic fibrosis, bronchiectasis or COPD (chronic obstructive pulmonary disease). If you have questions about the prescribed medication inside the nebulizer, please talk to your healthcare provider. 

A nebulizer compressor (also called a nebulizer machine) is a medical device intended to deliver compressed air to a jet or pneumatic nebulizer. Compressors can be electrically, or battery powered. 

Your physician may order your inhaled medication to be given with a nebulizer instead of by an inhaler (puffer). Elderly or those unable to operate or coordinate the use of an inhaler may find a nebulizer easier to use. Please talk to your healthcare provider about which drug delivery type is right for you. 

With breath actuated delivery, aerosol is only produced when you breathe in. This means medication is not wasted between breaths or if you need to take a break (for example if you need to cough or have a conversation). This puts you in control of your aerosol treatment. Other nebulizers continuously produce aerosol regardless of whether you are inhaling, exhaling or resting, resulting in medication being lost to the air instead of delivered to your lungs. 

Learn more about the difference breath actuated delivery can make!

The AEROECLIPSE* XL BAN* Nebulizer only produces aerosol when you inhale, so treatment time is dependent on your breathing pattern and breaks you might take during your treatment. The dose (or amount of medication) and the gas source you use (for example, compressor) are other factors that affect treatment time.

Nebulizer design and the dose or amount of medication it’s delivering affect treatment time. To keep treatment time consistent, it’s important to properly care for your nebulizer according to the device’s instructions for use.

The frequency of your nebulizer treatments depends on the type and severity of your condition. Please speak with your health care provider to understand what’s right for you.

Nebulizers are often selected for patients such as infants and small children. Please speak with your health care provider to understand what’s right for your child.

Nebulizers convert medication into an aerosol or mist that can be inhaled into your lungs. Nebulizers are used in the treatment of cystic fibrosis (CF), bronchiectasis, chronic obstructive pulmonary disease (COPD), asthma and other respiratory conditions.

The number of nebulizer treatments depends on the type and severity of your condition. Treatments may be recommended once or twice to several times daily. Please speak with your health care provider to understand what’s right for you.

The AEROECLIPSE* XL BAN* Nebulizer is an innovative device that produces aerosol only when you breathe in. Most other nebulizers continuously produce aerosol regardless of whether you are inhaling, exhaling or resting. As a result, a large portion of the prescribed medication in a continuous nebulizer is released to the environment and is not inhaled. Care providers and others in your immediate surroundings have the risk of inhaling potentially harmful aerosolized emissions.

Learn more about the difference breath actuated delivery can make!

The green feedback button on the top of the AEROECLIPSE* XL BAN* Nebulizer lowers when you inhale indicating that aerosol is being produced. When you stop inhaling, the button returns back to its original position indicating aerosol production has stopped. This movement can help encourage you to take long, slow breaths.

Down Position: Lowers upon inhalation.

Up Position: Rises back to the original ‘up’ position at the end of inhalation or between breaths.

Yes, the mouthpiece on the AEROECLIPSE* XL BAN* Nebulizer can be removed and replaced with a COMFORTSEAL* Mask. The silicon mask contours gently to your face, providing a secure and comfortable fit, The COMFORTSEAL* Mask is available in small, medium and large sizes.

1. Ensure the exhalation valve on the mouthpiece faces down.
   • Warning: It is important to prevent exhaled breath from blowing near the eyes. Refer to the drug product monograph for more information.
   • Note: For patients unable to use the mouthpiece, the nebulizer can be used with a COMFORTSEAL* Mask.
      
2. Inhale and exhale through the nebulizer mouthpiece to verify the movement of the green feedback button on the top of the nebulizer. The button should move up and down freely.
3. Unscrew and remove the top of the nebulizer. Place prescribed drug into the nebulizer cup. Reattach the top and gently hand tighten. Note: Keep the nebulizer in an upright position so the drug does not spill.
4.    
   • Use With Compressor. Attach one end of the tubing to the fitting in the bottom of the nebulizer and the other end to the compressor. Ensure both ends are securely attached. Turn on the compressor. Note: The nebulizer may be used with an Ombra* Compressor or an air source capable of delivering 103 to 170 kPa (15 to 25 psi) and 4 L/min when connected to the nebulizer.
   • Hospital Use With Wall Air. Attach one end of the tubing to the fitting in the bottom of the nebulizer and the other end to the flowmeter or compressed air source. Ensure both ends are securely attached. Set the flowmeter to 7 to 8 L/min with a compressed air source capable of delivering 345 kPa (50 psi).
5. Place the mouthpiece in mouth, and inhale slowly and deeply. As you inhale, the green feedback button will move into the down position. This indicates the nebulizer is producing aerosol. Exhale normally. As you exhale, the green feedback button will move into the up position. This indicates the nebulizer is not producing aerosol. Note: Do not place the lips over the exhalation valve on the bottom of the mouthpiece. Doing so will prevent the valve from functioning properly. Note: Ensure the nebulizer remains upright for proper nebulization.
6. Continue to inhale from the nebulizer until it starts to sputter, or as instructed by your health care provider.
7. Turn off the compressed air source. Note: Disconnect the tubing from the compressed air supply after use.

Refer to the instructions for use for additional information.

Quick Start Guide

To use the AEROECLIPSE* XL BAN* Nebulizer in breath actuated mode, move the mode selector on the top of the nebulizer to the breath actuated position (*). If there is a time when you would rather have a continuous mist, simply move the mode selector clockwise to the continuous mode position (**). 

*Breath actuated position:

**Continuous mode position:

Yes, simply use the device in the continuous mode position. Simply move the mode selector clockwise to the continuous mode position (**).

** Continuous mode position:

The AEROECLIPSE* XL BAN* Nebulizer should be replaced after 6 months of use.

We recommend cleaning the nebulizer (excluding tubing) after each treatment.

The nebulizer (excluding tubing) can be cleaned after each use.

1. The mode selector should be in the breath actuated position (*).
2. Remove the EZ TWIST Tubing from the bottom of the nebulizer.
3. Unscrew and remove the nebulizer top.
4. Shake out excess drug.
5. Use any of the following methods to clean the nebulizer.
   1. Hand Washing: Soak the three parts in a mild solution of liquid dish detergent and lukewarm clean water for about 5 minutes. Agitate gently. Rinse thoroughly with clean water. Shake out excess water.
   2. Dishwasher: Secure the three parts in a basket on the top rack. Run the dishwasher on a normal cycle. Do not heat dry. Shake out excess water.
6. Briefly connect the tubing to the bottom of the nebulizer cup and the compressed air supply to clear the air pathway.
7. Allow the nebulizer parts to air dry before reassembly.
8. Reattach the nebulizer top, making sure to line up the white cylinder with the stem of the nebulizer cup. Gently hand tighten until a stop is detected.
9. Reattach the mouthpiece to the nebulizer with the exhalation valve facing down.
10. After the nebulizer is fully dry and assembled, store in a clean plastic bag or container.

Refer to the instructions for use for additional information.

*Breath actuated position:

The nebulizer (excluding tubing) can be disinfected each day. First, follow the cleaning instructions. Do not dry or reassemble the nebulizer. Use any of the following methods to disinfect the nebulizer.

1. Boiling: Place the three parts in a pot with boiling water and boil for 15 minutes. Remove from the water without touching the water. Allow the parts to air dry thoroughly before reassembling. Note: Place a small rack on the bottom of the pot to prevent parts from coming in contact with the hot bottom.
2. Isopropyl Alcohol: Wipe the outside surfaces of the three parts with a tissue dipped in 70% isopropyl alcohol then submerge the three parts in a soak of 70% isopropyl alcohol for 1 minute before shaking to remove excess alcohol. Rinse the parts thoroughly with sterile water. Allow the parts to air dry thoroughly before reassembling.
3. Bleach: Soak the three parts in a 1:50 bleach to water solution (1 tablespoon (15 mL) bleach in 3¼ cups (800 mL) water) for 3 minutes. Rinse the parts thoroughly with sterile water. Allow the parts to air dry thoroughly before reassembling. Note: You may substitute a respiratory equipment disinfectant (such as Milton^†, Dodie^†, Control III^† or Cidex^†) for the bleach solution. Follow the disinfectant instructions for use.
4. Electronic Steam Disinfector: Place the three parts in an electronic steam disinfector. Follow the manufacturer’s instructions for use. Remove the parts from the unit. Allow the parts to air dry thoroughly before reassembling.
5. Microwave Steam Bag: Place the three parts in a microwave steam bag (such as Quick Clean^† Micro-Steam^† bag). Follow the manufacturer’s instructions for use. Remove from the bag. Allow the parts to air dry thoroughly before reassembling.
6. Vinegar: Soak the three parts in a 1:3 vinegar to water solution (1 cup (250 mL) vinegar in 3 cups (750 mL) water) for 1 hour. Rinse the parts thoroughly with sterile water. Allow the parts to air dry thoroughly before reassembling.
7. After the nebulizer is fully dry and assembled, store in a clean plastic bag or container.

Refer to the instructions for use for additional information.

† trade-marks of the respective companies

You may notice condensation on the inside of the EZ TWIST Tubing. This is normal. To remove the condensation, simply connect one end of the tubing to the compressed air supply, and allow the air to run without the nebulizer attached. This will force air through the tubing, drying the inside. To clean the exterior, wipe with a damp cloth. Allow to air dry thoroughly.

Refer to the instructions for use for additional information.

The AEROECLIPSE* XL BAN* Nebulizer can be used in the hospital with wall air or with a compressor.

Clean, disinfect and sterilize the nebulizer before using it with a different patient. This will prevent cross infection.

The nebulizer (excluding the tubing) can be cleaned, disinfected and sterilized up to 150 times. The tubing must be replaced between patients.

Cleaning and Disinfection

1. The mode selector should be in the breath actuated position (*).
2. Remove the tubing from the bottom of the nebulizer.
3. Unscrew and remove the nebulizer top.
4. Shake out excess drug.
5. Soak the three parts in a 0.5 % solution of neodisher^† MediClean forte (or similar) cleaning agent for 5 minutes, agitating gently.
6. Load the parts into a washer-disinfector compliant to ISO 15883-1. Ensure the parts are oriented upright.
7. Run the cleaning and disinfection cycle. 
   Note: Use cleaning agent neodisher^† Mediclean. The use of a rinse agent is optional.
8. Following disinfection, remove the parts from the washer-disinfector. Shake out excess water. Allow the parts to air dry thoroughly.

Sterilization

1. After cleaning, disinfection, and air dry, pack and seal the nebulizer parts in a sterilization pouch compliant to ISO 11607-1 & 2 or EN 868-5.
   Note: The pouch should be no smaller than 70 mm x 120 mm. The white cylinder portion of the nebulizer top should be positioned in the pouch so it is not bent or pressed into corners where it can become bent (Figure 1).
2. Load the pouch in the sterilizer.
3. Sterilize according to ISO 17665-1 Moist Heat with any of the following parameter sets: 
   1. 3 pre-vacuum phases; 134 °C sterilization temperature; 3 minutes hold time; 1 minute dry time
   2. 3 pre-vacuum phases; 121 °C sterilization temperature; 20 minutes hold time; 1 minute dry time
   3. Note: Do not exceed a temperature of 137 °C.
4. Reassemble the nebulizer prior to next use.
5. Store in a clean plastic bag or container.
    

* Breath actuated position:

Figure 1:

Image

† trade-marks of the respective companies

The AEROECLIPSE* XL BAN* Nebulizer can be connected directly to the AEROBIKA* OPEP device for nebulizer therapy during inhalation with secretion mobilization during exhalation. To use, first remove the mouthpiece from your AEROECLIPSE* XL BAN Nebulizer. Then, attach the device to the nebulizer port of the AEROBIKA* OPEP device. No adaptor is required. Your healthcare provider will advise you which medication to use for your combined treatments.

Download the AEROBIKA* OPEP device instructions for information on how to use the device with the AEROECLIPSE* XL BAN* Nebulizer.

Yes, a filter kit is available for use with AEROECLIPSE* BAN* Nebulizers. The filter kit filters fugitive emissions (aerosolized medication)1, viruses2 and bacteria2 from the patient's exhaled breath. It reduces exposure of healthcare providers to potentially harmful emissions. The filter kit is a single patient, single use accessory (use only once).