Aerogen Ultra AG-AS7500-US, Инструкция по эксплуатации

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Aerogen ® Ultra Instruction Manual
• 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 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.
• 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 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.
• 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. 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 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.
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.