Aerogen Solo User guide

System Instruction Manual
www.aerogen.com

Aerogen®Solo System Instruction Manual
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Contents
Introduction 2
Indications for Use 2
System Warnings 4
Assembly & Installation 6
Installation For Use With A Ventilator 11
Optimum Use 13
Installation For Use Off-Ventilator 14
Nebulisation Modes 17
Functional Test 21
Aerogen Solo Aerosol Flow Rate Calculation 22
Troubleshooting 23
Warranty 25
Life Of Product 25
Specifications 26
Performance 27
Symbols 28
Appendix 1 29
Appendix 1: EMC Tables 31

Aerogen®
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Introduction
The Aerogen®Solo System is an iteration of the Aerogen®Pro System.
The indications for use of the Aerogen®Pro System are given below. The
Aerogen®Solo System consists of the Aerogen®Solo nebuliser and the
Aerogen®Pro-X Controller. It is intended for hospital use only to nebulise
physician-prescribed medications for inhalation which are approved for
use with a general purpose nebuliser. The Aerogen®Solo nebuliser is for
single patient use only and the Aerogen®Pro-X Controller is for re-use.
The Aerogen Solo System is suitable for intermittent and continuous
nebulisation of neonate, paediatric and adult patients as described in this
manual.
Indications for Use
The Aerogen Pro System is a portable medical device for multiple patient
use that is intended to aerosolise physician-prescribed solutions for
inhalation to patients on and off ventilation or other positive pressure
breathing assistance. The Aerogen Pro System is suitable for use in adult,
paediatric and neonate patients as described in the Instruction Manual.

Aerogen®Solo System Instruction Manual
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Aerogen Solo System
The Aerogen Solo System includes the following components:
Figure 1. Aerogen Solo System
1. Aerogen Solo With Plug
2. T-Piece (Adult)*
3. Aerogen Pro-X Controller
4. Controller Cable
5. AC/DC Adapter
6. Universal Mounting Bracket & Equipment Mount Adapter
7. Continuous Nebulization Tube Set*
8. Aerogen®Ultra* and I-Guard™Aerosol Mask
* Neonate and paediatric adapters, Continuous Nebulization Tube Set and
Aerogen Ultra are sold separately. Visit www.aerogen.com for full parts list.
1 2 3 4
5 6 7 8

Aerogen®
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System Warnings
Read and study all instructions before using the Aerogen Solo
System and accessories. Only trained medical personnel should
operate the device.
This is a single patient use device not to be used on more than one patient
to prevent cross infection.
The components and accessories of the Aerogen Solo System, as
packaged, are not sterile.
The components and accessories of the Aerogen Solo System are not
made with natural rubber latex.
Inspect all parts before use, and do not use if any parts are missing,
cracked or damaged. In case of missing parts, malfunction or damage,
contact your sales representative.
Only use physician-prescribed solutions that are approved for use with
a general purpose nebuliser. Consult drug manufacturer’s instructions
regarding suitability for nebulisation.
Use only with Aerogen Solo components, connectors and any accessories,
which are specified by Aerogen in this instruction manual.
Do not use beyond defined life (see page 25).
Do not use in the presence of flammable substances or flammable
anaesthetic mixtures combined with air, oxygen or nitrous oxide.
To avoid the risk of fire, do not use to aerosolise alcohol-based medications,
which can ignite in oxygen-enriched air under high pressure.
Do not autoclave any component or accessory of the Aerogen Solo
System.

Aerogen®Solo System Instruction Manual
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Do not modify this equipment without the authorisation of the manufacturer.
Do not use or store outside of specified environmental conditions.
To avoid damage to the nebuliser:
•Do not apply undue pressure to the domed aperture plate in the centre
of the nebuliser.
•Do not push out the Aerogen Vibronic®aerosol generator.
•Do not use a syringe with a needle to add medication.
•Do not attempt to clean the nebuliser.
Use of the Aerogen Solo and T-piece during the administration of volatile
anaesthetics may result in adverse effects on the constituent plastics. Do
not use with volatile anaesthetics unless known to be compatible. Aerogen
have determined that, using anaesthetic ventilators, the following volatile
anaesthetic agents are compatible under the stated conditions below:
Anaesthetic Agent Proprietary Name
Maximum
Percentage of
Anaesthetic
Maximum Duration
of Exposure
Isoflurane FORANE®3.5 % 12 hours
Sevoflurane SEVOFLURANE®8 % 12 hours
Desflurane SUPRANE®10 % 12 hours

Aerogen®
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Assembly & Installation
Aerogen Solo System Set-Up
Perform a functional test of the Aerogen Solo before use as described in
the Functional Test section of this manual (See page 21).
Figure 2. Assembly of Aerogen Solo System
1. Connect the Aerogen Solo to the T-piece by pushing the nebuliser
firmly onto the T-piece.
2. Insert the Aerogen Solo and the T-piece into the breathing circuit.
Note: For use with other accessories, refer to Figure 9, Figure 10 and
Figure 11.
3. Connect the Aerogen Pro-X Controller to the Aerogen Solo using the
nebuliser cable.
4. To operate on AC power (the primary mode of operation), connect the
Aerogen Pro-X AC/DC adapter to the Aerogen Pro-X Controller.
5. Plug the adapter into an AC power source.

Aerogen®Solo System Instruction Manual
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6. The Aerogen Pro-X Controller can be battery-operated for portable
applications. The rechargeable battery can power the System for up
to 45 minutes when fully charged. In the case of AC power failure the
controller will automatically switch to battery operation.
7. Use the universal mounting bracket to attach the controller to an IV
pole or bed rail in either a vertical or horizontal orientation (Figure 3).
8. Where a standard equipment mount is available, use the equipment
mount adapter to support the controller (Figure 3).
Figure 3. Aerogen Pro-X Controller and universal mounting bracket
configurations
Warnings
•To ensure uninterrupted operation of the Aerogen Solo, secure both the
AC/DC adapter cable and the controller cable so they cannot become
disconnected during treatment. If clips are available on patient circuits,
run the cables through the eyes of the clips. If clips are not available,
ensure that all cables are routed safely.
•The AC/DC adapter is the means of isolating the Aerogen Solo System
from the mains power supply.
•The continuous mode can only be operated from AC power supply.
•Do not over-tighten knob on the universal mounting bracket.
Vertical
Universal Mounting Bracket
Horizontal
Universal Mounting Bracket
Equipment
Mount Adapter
Standard
Equipment Mount

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Aerogen Pro-X Controller
Controller
Cable Input
Error Indicator
30 Minute Mode
Indicator light
Continuous Mode
Indicator light
On/Off Power
• 30 Min. - Press & Release
• Continuous Mode - 3 Sec. hold from off
Battery Status
Indicator
9V DC Input
Figure 4. Aerogen Pro-X Controls & Indicators

Aerogen®Solo System Instruction Manual
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Control / Indicator Function
30 Min. Indicator
• Green (steadily lit) = 30 Minute
nebulisation cycle on
• Green (flashing) = Low battery
power
• Nebuliser automatically powers off after
30 minutes have elapsed
Continuous Indicator
• Green (steadily lit) = Continuous
nebulisation cycle on
• Nebuliser does not power off
automatically
Error Indicator
• Amber (steadily lit) = Aerogen Solo
nebuliser disconnected from Aerogen
Pro-X Controller
• Amber (flashing) = Aerogen Pro-X drive
voltage error
On/Off Power Button
• To operate in 30 Minute Mode, press the
On/Off button once
• To operate in Continuous Mode, press
and hold the On/Off button for greater
than 3 seconds from off
• Pressing during nebulisation turns off
power to the nebuliser
Battery Status Indicator
• Green = Battery fully charged
• Amber = Battery charging
• No light = Battery in operation
Recharging the Battery
To recharge the battery, connect the AC/DC adapter to the controller and
connect to AC power source. The battery status indicator is amber while
charging and green when fully charged.
If the controller is placed in long-term storage, it is recommended that the
battery be recharged every 3 months.
Allow a minimum of four hours for the internal battery to fully recharge.
Table 1. Aerogen Pro-X Controls & Indicators

Aerogen®
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Cleaning the Aerogen Pro-X Controller
Cleaning of controller and controller cable, AC/DC adapter and mounting
brackets:
1. Wipe clean with an alcohol based disinfectant wipe or a quaternary
ammonium compound based disinfectant wipe.
2. Check for exposed wiring, damaged connectors, or other defects and
replace controller if any are visible.
3. Visually inspect for damage and replace the controller if any damage
is observed.
Warnings
•Do not immerse or autoclave the Aerogen Pro-X Controller, cable or
AC/DC adapter.
•Do not place the Aerogen Pro-X Controller in an incubator during use.
•Do not use abrasive or sharp tools.
•Do not spray liquid directly onto the controller.
•Do not wrap the nebuliser cable tightly around any of the system
components.
•Do not use in the presence of devices generating high electromagnetic
fields such as magnetic resonance imaging (MRI) equipment.
•The Aerogen Pro-X Controller contains a nickel metal hydride (NiMH)
rechargeable battery, which should be disposed of in accordance with
local governing regulations at the end of its useful life.
•Follow local laws and recycling plans regarding disposal or recycling of
components, batteries and packaging.

Aerogen®Solo System Instruction Manual
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Installation for use with a Ventilator
T-Pieces - Connection to a Breathing Circuit
1. For 22mm adult breathing circuits connect the nebuliser with adult
T-piece into the inspiratory limb of the breathing circuit before the
patient Y (Figure 5).
Figure 5. Connecting the Aerogen Solo to a breathing circuit
Note: Figure 5 shows adult configuration only
For 15mm paediatric breathing circuits connect the nebuliser with
the paediatric T-piece into the inspiratory limb of the breathing circuit
before the patient Y.
The Aerogen Solo can connect to 10mm neonate breathing circuits
with the 15mm paediatric T-piece and the neonate adapters. This can
be positioned approximately 30cm (12 in.) back from the patient Y
(Figure 6).
Figure 6. Connecting to a neonate breathing circuit

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2. The Aerogen Solo can be placed on the dry side of the humidifier as
shown in Figure 7. The Aerogen Solo can be used with a nasal interface
in this configuration.
Figure 7. Aerogen Solo on dry side of humidifier
3. Follow ventilator manufacturer instructions for performing a leak test
after inserting or removing the nebuliser.
Warnings
•Condensate can collect and occlude ventilator circuits. Always position
ventilator circuits so that fluid condensate drains away from the patient.
•Always connect a bacteria filter to the expiratory inlet of the ventilator.
Otherwise the function of the expiratory channel may be degraded.
•Do not use a filter or heat-moisture exchanger (HME) between the
nebuliser and patient airway.

Aerogen®Solo System Instruction Manual
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Optimum Use
For optimum use of the Aerogen Solo, ensure it is correctly orientated as
shown in Figure 8. This applies to both 30 Minute and Continuous modes.
Figure 8. Optimum Use of the Aerogen Solo

Aerogen®
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Installation for use Off-Ventilator
Use with a Face Mask
Mask kits, which include a vented elbow and mask elbow, are available
separately (visit www.aerogen.com for full parts list).
1. When using a mask, connect the vented elbow, mask elbow and mask
to the nebuliser by firmly pushing the parts together.
2. Rotate the vented elbow to suit the position of the patient (Figure 9).
Figure 9. Connecting to a mask
Use with a Mouthpiece
The Aerogen Solo is compatible with any standard ISO 22mm nebuliser
mouthpiece inserted into the adult T-piece.
When using a mouthpiece, connect the nebuliser to the T-piece and
then connect the T-piece to the mouthpiece by pushing the parts firmly
together as shown in Figure 10.
Figure 10. Connecting to a mouthpiece
Patient Upright
Patient Reclined
Face Mask
Elbow
Vented
Elbow
Patient Upright
Patient Reclined
Face Mask
Elbow
Vented
Elbow

Aerogen®Solo System Instruction Manual
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Warning: To ensure correct nebulisation, maintain the nebuliser in a
vertical orientation (Figure 9 & Figure 10).
Use with a Nasal Interface
The Aerogen Solo can be used on/off ventilator with a nasal interface
when configured with a humidifier (Figure 7).
Aerogen Ultra
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.
Optimal aerosol delivery is achieved with a valved mouthpiece or valved
aerosol face mask with low/no oxygen flow.
Inspect for device integrity and correct valve placement prior to use.
Oxygen Tubing
Face Mask
Aerogen Solo
Mouthpiece
Aerogen Ultra
Figure 11. Assembly of Aerogen Ultra

Aerogen®
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1. Insert Aerogen Solo nebuliser firmly into Aerogen Ultra in orientation
shown in Figure 11.
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. Add medication to nebuliser.
5. Connect cable to Aerogen Solo and power on controller.
6. Introduce Aerogen Ultra to patient and observe aerosol flow to ensure
correct operation.
7. Remove excess rainout from the Aerogen Ultra periodically (hourly with
continuous nebulisation).
8. 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
•Do not use with a closed face mask.
•When using with an open face mask, always use supplemental oxygen
flow of 1-6 LPM.
•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.
•Ensure oxygen connection port or tubing is not occluded.
•Do not use Aerogen Ultra without a mouthpiece or face mask.
•Visually check Aerogen Ultra post-rinsing to ensure that valves have
not become dislodged.
•Do not cover Aerogen Ultra valves during use.
•Do not use Aerogen Ultra in conjunction with the Aerogen Pro.
•Do not autoclave any component of the kit.
•Ensure tubing is safely orientated to prevent strangulation hazard.

Aerogen®Solo System Instruction Manual
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Nebulisation Modes
30 Minute Mode (Intermittent)
Warnings
•To avoid damage to the Aerogen Solo, do not use a syringe with a
needle.
•During use observe for correct functioning of the nebuliser.
•The maximum capacity of the nebuliser is 6 mL.
For intermittent doses less than or equal to 6 mL:
1. Open the plug on the nebuliser.
2. Use a pre-filled ampoule or syringe to add medication into the filler port
of the nebuliser (Figure 12).
3. Close the plug.
Figure 12. Filling the nebuliser with a pre-filled ampoule
4. To start a 30 Minute nebulisation cycle, press and release the blue
On/Off power button (Figure 4). The green 30 Minute indicator light
illuminates to indicate that the 30 Minute nebulisation cycle is in
progress.
5. To stop the nebuliser at any time, press the On/Off power button. The
indicator turns off to indicate that nebulisation has stopped.
Note: Medication can be added to the Aerogen Solo during nebulisation.
This does not interrupt nebulisation or ventilation.

Aerogen®
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Continuous Mode
Continuous Nebulization Tube Set
The Aerogen Continuous Nebulization Tube Set is an accessory specific
to the Aerogen Solo nebuliser which enables safe continuous infusion of
liquid medication for aerosolisation.
Note: Place the syringe cap on the syringe after it is filled with medication.
Figure 13. Continuous Nebulization Tube Set
1. Ensure the Aerogen Solo nebuliser is firmly fitted into the Aerogen Solo
T-piece in the breathing circuit.
2. Remove the syringe cap from the medication-filled syringe.
3. Attach the syringe end of the tubing onto the syringe.
4. Prime the tubing until the medication reaches end of tubing (Point A).
Note: The tubing priming volume is maximum 3.65 mL.
5. Unplug the tethered silicone plug from the Aerogen Solo nebuliser, but
do not remove it from the nebuliser.
6. Screw the nebuliser end of the tubing onto the top of the nebuliser.
ASyringe Cap
Syringe
Tubing
(Syringe End)
Tubing
Tethered Silicone Plug
Tubing
(Nebuliser End)