FAQ - Aeroneb Pro

  1. How often do I need to clean the nebulizer?
  2. How do I clean the Aeroneb Pro?
  3. What washing cycles can I use?
  4. What brands or models of ventilators can use the Aeroneb Pro?
  5. How long does it take to deliver a unit dose?
  6. How much medication is left at the end of a treatment?
  7. What medications can the Aeroneb Pro deliver?
  8. How much medication can be given at one time?
  9. Can I use Mucomyst?
  10. Can the Aeroneb Pro be used off the ventilator?
  11. How quiet is the Aeroneb Pro?
  12. How long will the Aeroneb Pro last?
  13. What is the lung delivery with the Aeroneb Pro?
  14. What should I do if the unit stops working?
  15. How do I get replacement parts?

 

1. How often do I need to clean the nebulizer?

The nebulizer should be rinsed with sterile water and air dried after each treatment. Between patients, the Aeroneb Pro should be washed with mild liquid detergent and warm water, air dried and then sterilized or disinfected in accordance with your hospital's policy. Refer to the cleaning and sterilizing section in the instruction manual for complete details.

 

2. How do I clean the Aeroneb Pro?

This section describes how to clean, disinfect, sterilize and inspect Aeroneb® Pro system components. It is important that Aeroneb® Pro device components are cleaned and sterilized/disinfected prior to first patient use. The components are:

  • Nebulizer unit (including filler cap)
  • T-piece (including T-piece plug) for adult and pediatric adapters.
  • Control module†,
  • control module cable†, and
  • AC/DC adapter†
  • Mounting bracket†

† Components not to be autoclaved.

CAUTION: Always clean, sterilize and disinfect in accordance with current hospital protocols.

To avoid damage to the nebulizer:

Autoclave according to specified directions and temperature given in the "Cleaning, disinfection and sterilization" section of this Instruction Manual only. Any deviation from directions given in this Instruction Manual may cause damage to the nebulizer unit and render it inoperable.Do not apply undue pressure to the domed aperture plate in the center of the nebulizer.Do not push out the OnQTM Aerosol Generator

Cleaning nebulizer unit, T-pieces and pediatric adapters
  1. Remove nebulizer unit from T-piece. Remove filler cap from nebulizer unit.
  2. Clean all parts with warm water and mild liquid detergent.
  3. Rinse parts with sterile water.
  4. Shake excess water from parts and allow parts to air dry.
Disinfection of nebulizer unit, T-adapters and pediatric adapters

Follow steps 1 through 3 above. Completely immerse parts in appropriate disinfecting agent.

NOTE: Aerogen approves the following disinfection solutions for use with its Aeroneb® Pro Nebulization System regarding material compatibility. With respect to microbiological effectiveness, please ask the manufacturer. Refer to the product labeling for specific instructions regarding activation, safe use and disposal of these solutions.

Ethylene alcohol (70%) CIDEX® NU-CIDEX® CIDEX® OPAHexanios G+R

Sterilization of nebulizer unit, T-pieces and pediatric adapters

Disconnect the nebulizer unit from the control module, and then remove the nebulizer unit and adapters from the ventilator circuit, mask or mouthpiece. Disassemble the nebulizer unit and adapters into individual components. Remove the filler cap from the nebulizer unitClean all parts with warm water and mild liquid detergent. Rinse thoroughly and air dry.Check for cracks or damage and replace if any defects are visible. Place the disassembled components into appropriate sterilization wrapping.

CAUTION: Do not reassemble parts prior to autoclaving.

Sterilize components:

Steam sterilization can be performed using the following three methods:

  • Autoclave wrapped parts using steam sterilization pre-vacuum cycle, a minimum of 134°C (270°F - 275°F) for 3.5 minutes with drying cycle (134°C wrapped cycle). 
  • Autoclave wrapped parts using steam sterilization pre-vacuum cycle, a minimum of 121°C (250°F) for 20 minutes with drying cycle (121°C wrapped cycle).
  • Autoclave wrapped parts using steam sterilization pre-vacuum cycle, a minimum of 134°C (270°F - 275°F) for 20 minutes with drying cycle (sometimes referred to as a "Prion cycle").

NOTE: Sterilization using the long autoclave cycle may cause some areas of the nebulizer to become discolored. This is not indicative of the performance of the nebulizer unit.

To sterilize with hydrogen peroxide gas plasma, place wrapped parts in a STERRAD® System, and use the long cycle.
CAUTION: Users should refer to the product labeling for the STERRAD® 100S Sterilization System for specific instructions regarding its proper operation.

Prior to next use:

Check for cracks or damage and replace if any defects are visible. Perform a functional test as described in this manual.

Cleaning of mounting brackets

Wipe clean with a damp cloth and mild liquid detergent. Do not use abrasive or sharp tools.

Cleaning of control module, control module cable and AC/DC adapter

Wipe clean with a damp cloth. Do not autoclave. Check for exposed wiring, damaged connectors, or other defects and replace if any are visible.

Note: The Aeroneb Pro nebulizer unit contains active electronic components. Aerogen has validated the methods of cleaning, disinfection and sterilization above. The use of any other means of cleaning, disinfection or sterilization has not been validated and is likely to reduce the life of your nebulizer and will invalidate your warranty.

 

3. What washing cycles can I use?

The Aeroneb Pro Nebulizer System has been successfully validated with the following automated washing cycles. Each of these cycles was repeated 50 times. The nebulizers were characterized before and after the validations were carried out and were within acceptance criteria.

Cycle One:

Equipment: Miele G 7835 CD Washer/Disinfector

Detergent: neodisher® MediClean forte, Dr Weigert

Method:

1. Pre-rinse the test items with cold tap water for 3 minutes

2. Clean the test items with neodisher® MediClean forte (10mL/L) at 55°C for 10 minutes

3. Follow on with an immediate rinse with cold tap water for 1 minute

4. Rinse with tap water using thermal disinfection cycle at 93°C for 10 minutes

Cycle Two:

Equipment: Getinge Decomat 4556 Washer/Disinfector.

Detergent: The following cycle was validated without the use of a detergent

Method:

1. Wash test items for 10 minutes at 91°C

2. Drain the machine for 40 sec

3. Rinse with hot water at 90°C for 1 minute

4. Drain the machine for 40 seconds

5. Rinse with hot water at 90°C for 1 minute

6. Drain the machine for 40 seconds

7. Dry at 90°C for 15 minutes

 

4. What brands or models of ventilators can use the Aeroneb Pro?

The Aeroneb Pro can be used with any brand or model of ventilator.

 

5. How long does it take to deliver a unit dose?

3.0mL of albuterol is delivered 7-10 minutes. Results may vary depending on type of medication.

 

6. How much medication is left at the end of a treatment?

Residual volume is less than 0.1mL on a 3mL dose.

 

7. What medications can the Aeroneb Pro deliver?

The Aeroneb Pro is cleared for use with any drugs that are approved for use with a general purpose nebulizer. Refer to medication labeling for instructions regarding nebulizer use.

 

8. How much medication can be given at one time?

The medication cup can hold up to 10mL of medication.

 

9. Can I use Mucomyst® with the Aeroneb Pro?

Yes. Mucomyst is effectively nebulized using the Aeroneb Pro nebulizer system. Correct cleaning of your Aeroneb Pro nebulizer after nebulizing Mucomyst, as outlined in the current Instructions for Use manual, is very important.

Inadequate cleaning or not cleaning your Aeroneb Pro nebulizer after administration of Mucomyst can result in a residue of the drug remaining on the aerosol generator and the surrounding washer in the center of your nebulizer. If this residue is not washed off properly before the nebulizer is autoclaved, the area around the aerosol generator may become discolored. Mucomyst should not be allowed to dry onto the aerosol generator of your Aeroneb Pro nebulizer, particularly in situations where a patient is being treated with more than one nebulized therapy.

Such practice could potentially result in a sticky build-up on the aperture holes of the aerosol generator and reduce the nebulizer's ability to aerosolize medication. It is important to note that Aerogen's metallic aerosol generator is made from a highly corrosive resistant material and as such, is not directly affected by the use of Mucomyst®.

General Recommendation

As always, we recommend that cleaning, disinfection and sterilization of the Aeroneb Pro Nebulizer are carried out in accordance with your current hospital procedures. However, when using Mucomyst, we further recommend that you introduce 1mL of sterile water into the nebulizer after dosing with Mucomyst and before the nebulizer dries out in order to rinse off any remaining Mucomyst.

 

10. Can the Aeroneb Pro be used off the ventilator?

Yes. It can be used off vent with a mouthpiece or standard aerosol mask off the ventilator. Refer to the instruction manual for details.

 

11. How quiet is the Aeroneb Pro?

The Aeroneb Pro generates a sound intensity level of 35dB, just above a whisper (30dB). The average ambient noise level in an ICU is about 50 to 60dB.

 

12. How long will the Aeroneb Pro last?

The Aeroneb Pro system is designed to be reusable and the autoclavable nebulizer is expected to last for approximately 1 year of average use. Refer to your local distributor regarding warranty details.

 

13. What is the lung delivery with the Aeroneb Pro?

Deposition depends on medication dosage and volume, type of patient, ventilator settings, humidification and placement in the circuit.

In vitro and animal studies have shown deposition rates to be:

Animal Data:

Adult 13-14% of nominal dose

InVitro with HFOV:

Adult 10% of nominal dose.

 

14. What should I do if the unit stops working?

Refer to the trouble shooting guide on the left hand side.

 

15. How do I get replacement parts?

Contact your local Aeroneb Pro Distributor