Aerogen Ultra AG-AS7000-EUR Instruction Manual Download Page 4

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Aerogen®

The Aerogen

Ultra is an accessory specific to the Aerogen Solo nebuliser. It facilitates intermittent and continuous

nebulisation, with optional supply of supplemental oxygen to paediatric and adult patients via mouthpiece. The device

can alternatively be used with a face mask, as supplied.
It is a single patient use device which is qualified for 20 intermittent use treatments (at a rate of four 3 ml doses per day

over 5 days) or 3 hours of continuous use.
For continuous use, the Aerogen Ultra can be used in conjunction with the Aerogen Solo Continuous Nebulization Tube

Set. See Aerogen Solo System Instruction Manual.
Optimal aerosol delivery is achieved with valved mouthpiece or valved aerosol face mask with low/no oxygen flow.
The Aerogen Ultra is for use in spontaneous and conscious breathing patients only.
The Aerogen Ultra, Mouthpiece, Aerogen Solo nebuliser, oxygen tubing and I-Guard

Aerosol Mask are non-sterile.

The filter is not supplied by Aerogen. The image of the filter has been included for demonstration purposes. It is the

responsibility of the clinician to determine if a filter is required and the type of filter selected for use (Viral/Bacterial) in

conjunction with the Aerogen Ultra. When selecting a filter for attachment to the Aerogen Ultra mouthpiece, Aerogen

recommend using a filter with a minimum efficiency rating of 99.9% (Bacterial) or 99.8% (Viral).
If using the Aerogen Ultra in conjunction with a filter, refer to the filter manufacturer’s Instructions for Use for information

including filter disposal.
For disposal of the Aerogen Ultra, Mouthpiece, Aerogen Solo nebuliser and oxygen tubing, refer to hospital or

institutional protocol, for disposal of the I-Guard

Aerosol Mask refer to manufacturer’s instructions.

The following devices are governed

under CE0050

The following devices are not

governed under CE0050

•  The Aerogen Ultra & oxygen tubing
•  The Aerogen Ultra Mouthpiece
•  The Aerogen Solo Nebuliser

• The I-Guard

™

Aerosol Mask

• The Filter

Aerogen Ultra Kits

AG-AS7500-EUR:

Aerogen Ultra Starter Kit (10 pack): Aerogen Solo, Aerogen Ultra, oxygen tubing

AG-AS7000-EUR:

Aerogen Ultra (10 pack): Aerogen Ultra, oxygen tubing

AG-AS7501-EUR:

Aerogen Ultra Starter Kit (10 pack): Aerogen Solo, Aerogen Ultra, oxygen tubing, I-Guard

Aerosol

Mask (Adult)

AG-AS7502-EUR:

Aerogen Ultra Starter Kit (10 pack): Aerogen Solo, Aerogen Ultra, oxygen tubing, I-Guard

Aerosol

Mask (Paediatric)

AG-AS7001-EUR:

Aerogen Ultra, oxygen tubing, I-Guard

Aerosol Mask (Adult)

AG-AS7002-EUR:

Aerogen Ultra (10 pack): Aerogen Ultra, oxygen tubing, I-Guard

Aerosol Mask (Paediatric)

Instructions for Use - Refer to Figures 1 - 9

Inspect for device integrity and correct valve placement prior to use.
1. Insert the Aerogen Solo nebuliser firmly into Aerogen Ultra in orientation shown.

2. If supplemental oxygen is required, firmly attach oxygen tubing to Aerogen Ultra.

Note:

Oxygen flow rate should be set between 1-6 LPM.

3. If a face mask is required, remove mouthpiece and attach face mask to Aerogen Ultra.

Note:

When using an open face mask, a minimum oxygen flow of 1 LPM is required.

4. If use of a filter is required, the Aerogen Ultra Mouthpiece has a 22mm(F) ISO 5356-1 connection port to facilitate

the attachment of a ISO 5356-1 compliant filter port.

5. Add prescribed medication to the Aerogen Solo nebuliser as instructed in Aerogen Solo System Instruction Manual.

6. Connect cable to Aerogen Solo.

Note:

Refer to Aerogen Solo System Instruction Manual for intermittent and continuous nebulisation set-up and