Aerogen Ultra User manual
Instruction Manual
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+1 (866) 423-7643US.
© 2022 Aerogen Ltd.
P/N 30-715 Rev G
Manufacturer
Aerogen Ltd.
Galway Business Park,
Dangan, Galway,
Ireland.
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• The Aerogen®Ultra is an accessory specific to the Aerogen®Solo nebulizer.
• It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen
to pediatric (29 days or older) and adult patients in hospital use environments via mouthpiece or
aerosol face mask. If supplemental oxygen is used, for pediatric patients under 18 years of age, a
maximum flow rate of 2 LPM should be used.
Note: The mouthpiece should not be used for children under 5 years of age.
• The Aerogen Ultra is for spontaneous and conscious breathing patients only.
• The Aerogen Ultra, Mouthpiece, Aerogen Solo nebuliser, oxygen tubing, I-Guard™ Aerosol Mask
and filter (if supplied by Aerogen) are non-sterile.
• The filter is supplied by Aerogen within Kits AG-AS7509-US and AG-AS7009-US. It is the
responsibility of the clinician to determine if a filter is required.
• The filter supplied by Aerogen as part of the Aerogen Ultra kit, has a minimum efficiency rating of
99.99% (Bacterial) or 99.99% (Viral).
• If selecting a filter that is not supplied by Aerogen for the attachment of the Aerogen Ultra
mouthpiece, Aerogen recommend using a filter with a minimum efficiency rating of 99.9%
(Bacterial) or 99.8% (Viral).
• For disposal of the Aerogen Ultra, Mouthpiece, Aerogen Solo nebuliser, filter, and oxygen tubing,
refer to hospital or institutional protocol. For disposal of the I-Guard™ Aerosol Mask refer to
manufacturer’s instructions.
• If using the Aerogen Ultra in conjunction with the Aerogen supplied filter, refer to the Warnings
section.
• If using the Aerogen Ultra in conjunction with a non-Aerogen supplied filter, refer to the filter
manufacturer’s Instructions for Use for information including filter disposal.
• The Aerogen Ultra is a single patient use device with a validated defined life of:
• In intermittent use for a maximum of 20 treatments; which is based upon a typical usage profile
of four 3 ml doses per day over 5 days, with an average treatment time of 9 minutes.
or
• In continuous use, for a maximum of 3 hours.
• Each Aerogen supplied filter is intended for single patient use up to 24 hours and is not intended
for reuse.
• Change the Aerogen supplied filter every 24 hours or more frequently if it becomes obstructed.
When using a non-Aerogen supplied filter, refer to manufacturer’s instructions.
• Ensure correct operation of the Aerogen Ultra when a filter is in use, ensuring that the filter is
secure and free from leaks.
• 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 face mask (as supplied)
with low/no oxygen flow.
Instructions for Use - Refer to Figures on Page 1
Inspect for device integrity and correct valve placement prior to use.
1. Insert Aerogen Solo nebulizer 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 for adult and a maximum of 2 LPM for
pediatric patients less than 18 years of age.
3. If an aerosol face mask is required, remove mouthpiece and attach the aerosol face mask to
Aerogen Ultra.
Note: When using an aerosol face mask, a minimum oxygen flow of 1 LPM is required.
4. 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. Kits AG-AS7509-US and AG-AS7009-US are supplied with a
filter.
5. Add prescribed medication to nebulizer 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
nebulization set-up and operation instructions.
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7. Power on and observe Aerogen Ultra to confirm aerosol is visible.
8. Introduce Aerogen Ultra to patient and observe aerosol flow to ensure correct operation.
9. Remove excess rainout from the Aerogen Ultra periodically (hourly with continuous nebulization).
To ensure optimum performance of the Aerogen Ultra, remove any residue by rinsing through
with sterile water, shake off excess and allow to air dry.
Warnings
Performance
Do not use with a closed face mask or a standard oxygen mask.
When using with an aerosol face mask, always use supplemental oxygen flow of 1-6 LPM for adult
and a maximum of 2 LPM for pediatric patients less than 18 years of age.
Performance of the Aerogen Ultra may vary depending upon the type of drug and Aerogen Ultra
configuration used.
Do not exceed recommended oxygen flow for system.
Visually check Aerogen Ultra post-rinsing to ensure that valves have not become dislodged.
When connecting a 22mm(M) breathing system filter to the Aerogen Ultra Mouthpiece, ensure that
the filter does not occlude the exhalation valve of the mouthpiece.
If using a non-Aerogen supplied filter, change filter as per manufacturer instructions or more
frequently if it becomes obstructed.
The Aerogen Ultra, when used in combination with the Mouthpiece, Aerogen Solo nebulizer and a
filter (with a recommended minimum efficiency rating of 99.9% (Bacterial) or 99.8% (Viral)) has the
ability to reduce but not eliminate the risk of transmission or acquisition of an infectious agent by
healthcare workers or others.
The Aerogen supplied filter must be dry and free of secretions. Wet filter material may result in low
filtration efficiency.
Do not attempt to sterilize, autoclave or clean the Aerogen supplied filter.
General
To be used by trained personnel only.
Use only with recommended components.
Ensure tubing is safely orientated to prevent strangulation hazard.
Ensure oxygen connection port or tubing is not occluded.
Do not use the Aerogen Ultra without a mouthpiece or face mask.
Do not autoclave any component of the kit.
Do not cover Aerogen Ultra valves during use.
Aerogen Ultra Kits
AG-AS7500-US:
AG-AS7000-US:
AG-AS7501-US:
AG-AS7502-US:
AG-AS7001-US:
AG-AS7002-US:
AG-AS7509-US:
AG-AS7009-US:
AerogenUltra Starter Kit (10 pack): AerogenSolo, AerogenUltra, oxygen tubing
AerogenUltra (10 pack): AerogenUltra, oxygen tubing
Aerogen Ultra Starter Kit - Mask (10 pack): Aerogen Solo, Aerogen Ultra, oxygen
tubing, I-Guard™Aerosol Mask (Adult)
Aerogen Ultra Starter Kit - Mask (10 pack): Aerogen Solo, Aerogen Ultra, oxygen
tubing, I-Guard™Aerosol Mask (Pediatric)
Aerogen Ultra - Mask (10 pack): Aerogen Ultra, oxygen tubing, I-Guard™Aerosol
Mask (Adult)
Aerogen Ultra - Mask (10 pack): Aerogen Ultra, oxygen tubing, I-Guard™Aerosol
Mask (Pediatric)
Aerogen Ultra Starter Kit with filter (10 pack): Aerogen Solo, Aerogen Ultra, oxygen
tubing, filter
Aerogen Ultra with filter (10 pack): Aerogen Ultra, oxygen tubing, filter
Aerogen Supplied Disposable Bacterial/Viral Filter:
22mm ID x 15mm ID/22mm OD
Indications for Use
The disposable Bacterial/Viral filter is intended for use within respiratory devices where filtration of
particulate matter is desired. Each Aerogen supplied filter is intended for single patient use up to 24
hours, and is not intended for reuse.
Hydrophobic BFE: > 99.99%
Resistance to Flow: < 2cm H2O @60LPM
Hydrophobic VFE: > 99.99%
Resistance to Flow: 1cm H2O @30LPM
Symbols related to the Aerogen Supplied Filter
Symbol Meaning Symbol Meaning
Single patient use only Not made with
natural rubber latex
Keep dry Rx Only
Caution: Federal law restricts
this device to sale by or on
the order of a physician
Caution
Attention: Consult
accompanying documents
for important cautionary
information
This product is supplied non-
sterile
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