Aerogen Ultra Instruction Manual

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• The Aerogen Ultra is an accessory specific to the Aerogen
®
• 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.
Solo nebulizer.
®
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