Aerogen Pro User guide

System Instruction Manual
www.aerogen.com

Aerogen®Pro System Instruction Manual 1
Contents
Introduction 2
Indications for Use 2
System Warnings 5
Assembly & Installation 9
Installation For Use With A Ventilator 12
Nebulization 16
Installation For Use Off-Ventilator 17
Functional Test 19
Cleaning, Disinfection and Sterilization 20
Troubleshooting 26
Warranty 28
Life Of Product 28
Specifications 29
Performance 30
Symbols 31
Appendix 1 32
Appendix 1: EMC Tables 34

2Aerogen®
Introduction
The Aerogen®Pro System is a portable medical device for multiple patient
use that is intended to aerosolize physician-prescribed medications for
inhalation that are approved for use with a general purpose nebulizer. This
device can be used by patients on and off mechanical ventilation or other
positive pressure breathing assistance.
Aerogen®Pro is intended for hospital use only. It is suitable for use by
pediatric and adult patients as described in this manual. It incorporates
the Aerogen Vibronic®aerosol generator.
Aerogen®Pro is designed to operate in-line with standard ventilator
circuits and mechanical ventilators. It operates without changing patient
ventilator parameters and can be refilled without interrupting ventilation.
The controller operates from the AC/DC adapter and can be operated on
its internal rechargeable battery for up to 45 minutes when fully charged.
The product operates without compressed gas, making it suitable for
portable applications.
Indications for Use
The Aerogen®Pro System is a portable medical device for multiple
patient use that is intended to aerosolize 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
and pediatric patients.

Aerogen®Pro System Instruction Manual 3
Aerogen Pro System
The Aerogen Pro System includes the following components:
Figure 1. Aerogen Pro System
1. Nebulizer with Filler Cap
2. T-Piece (Adult) with Plug
3. Aerogen Pro Controller
4. Controller Cable
5. AC/DC Adapter
6. Universal Mounting Bracket & Equipment Mount Adapter
Note: Visit www.aerogen.com for full parts list.
1 2 3 4
5 6

4Aerogen®
1. The nebulizer holds up to 10 mL of liquid medication. The nebulizer
is translucent to allow visual monitoring of medication levels and
aerosolization. When the nebulizer is connected into the breathing
circuit, the filler cap can be opened or removed from the nebulizer
without causing loss of circuit pressure.
Within the nebulizer is the Aerogen Vibronic®aerosol generator, which
consists of a domed aperture plate with precision-formed holes that
control the size of the aerosol droplets and a vibrational element that
creates micro-pumping action to aerosolize medication. Gravity brings
the medication in contact with the aerosol generator; the liquid is then
drawn through the aperture plate and converted into an aerosol.
2. The T-piece securely connects the nebulizer into the breathing circuit
and can be easily removed for cleaning. The T-piece connections are
standard male and female 22 mm ISO conical ports and connect to
standard patient breathing circuits.
3, 4, 5.
The controller can operate from the AC/DC Adapter or the internal
rechargeable battery. The controller includes an On/Off power button
and sockets for the controller cable and the AC/DC Adapter. The
controller also includes indicators for nebulization cycle selection (15
or 30 minutes), battery charge status and fault conditions.
6. A Universal Mounting Bracket clamps the controller to standard IV
poles and medical rail systems.
7. An Equipment Mount Adapter mounts the controller on Standard
Equipment Mounts.
Note: Pediatric T-piece, Mask Adapter Kits, Elbow Connectors and
Mouthpiece are sold separately.

Aerogen®Pro System Instruction Manual 5
System Warnings
Read and study all instructions before using the Aerogen Pro System
and accessories. Only trained medical personnel should operate the
device.
During use observe for correct functioning of the nebulizer by regularly
verifying aerosol is visible and no flashing indicator lights.
Do not use a filter or heat-moisture exchanger (HME) between the nebulizer
and patient airway.
Do not attach a continuous supply of medication to the nebulizer; the
device operates in 15 or 30 minute cycles.
Clean, sterilize, assemble and perform a functional test (page 19) according
to the instructions in this manual before first use and between patients.
Do not place the controller in an incubator during use.
To avoid exhaled medication affecting the ventilator, follow ventilator
manufacturer’s recommendations for use of a bacterial filter in the
expiratory limb of a breathing circuit.
To ensure optimum drug administration, consult the drug manufacturer’s
instructions regarding suitability for nebulization.
Do not use in the presence of flammable substances or a flammable
anesthetic mixture combined with air or with oxygen or nitrous oxide.
To avoid the risk of fire do not use to aerosolize alcohol-based medications,
which can ignite in oxygen-enriched air and under high pressure.
Do not modify this equipment without the authorization of the manufacturer.
Disconnect the nebulizer from controller before cleaning.

6Aerogen®
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.
Do not immerse or autoclave the controller or AC/DC adapter.
Disassemble all parts before autoclaving.
Use only with components specified by Aerogen.
Do not use or store outside of specified environmental conditions.
To avoid mechanical or electrical damage, do not drop the nebulizer or
the controller.
Do not use in the presence of devices generating high electromagnetic
fields such as magnetic resonance imaging (MRI) equipment.
The Aerogen Pro controller contains a nickel metal hydride (NiMH)
rechargeable battery, which should be disposed of in accordance with
local governing restrictions at the end of its useful life.
To avoid damage to the nebulizer:
•Prior to use, autoclave according to specified directions and
temperature given in the Cleaning, Disinfection and Sterilization
section of this Instruction Manual only. Any deviation from directions
given in this Instruction Manual may cause damage to the nebulizer
and render it inoperable.
•Do not apply undue pressure to the domed aperture plate in the center
of the nebulizer.
•Do not push out the Aerogen Vibronic®aerosol generator.
•Do not use a syringe with a needle to add medication.
•Do not use abrasive or sharp tools to clean the nebulizer.

Aerogen®Pro System Instruction Manual 7
Aerogen Pro Controller
Controller
Cable Input
Error Indicator
30 Minute Mode
Indicator light
15 Minute Mode
Indicator light
On/Off Power
• 15 Min. - Press & Release
• 30 Min. - Press & hold for 3 Sec.
Battery Status
Indicator
9V DC Input
Figure 2. Aerogen Pro Controls & Indicators

8Aerogen®
Control / Indicator Function
15 Min. Indicator
• Green (steadily lit) = 15 Minute
nebulization cycle on
• Green (flashing) = Low battery power
• Nebulizer automatically powers off after
15 minutes have elapsed
30 Min. Indicator
• Green (steadily lit) = 30 Minute
nebulization cycle on
• Green (flashing) = Low battery power
• Nebulizer automatically powers off after
30 minutes have elapsed
Error Indicator • Amber = Faulty electrical connection
On/Off Power Button
• To operate in 15 Minute Mode, press and
immediately release the On/Off button
• To operate in 30 Minute Mode, press
and hold the On/Off button for at least 3
seconds from off
• Pressing during nebulization turns off
power to the nebulizer
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 Controls & Indicators

Aerogen®Pro System Instruction Manual 9
Assembly & Installation
Aerogen Pro System Set-Up
Clean and sterilize the nebulizer and T-piece(s) as described in the
Cleaning, Disinfection and Sterilization section of this manual.
Note: The nebulizer and T-piece, as packaged, are not sterile.
Perform a functional test of Aerogen Pro before use and between
patients as described in the Functional Test section of this manual
(see page 19).
Insert the filler cap into the opening on the nebulizer.
Connect the nebulizer to the T-piece by pushing the nebulizer firmly
onto the T-piece (Figure 3).
Figure 3. Connecting nebulizer to T-piece
1
2
3

10 Aerogen®
Connect the Aerogen Pro controller and the nebulizer together using
the controller cable (Figure 4).
Figure 4. Connecting controller and nebulizer
To operate on AC power (the primary mode of operation), connect
the Aerogen Pro AC/DC adapter to the Aerogen Pro controller
and plug the adapter into an AC power source (Figure 5).
Figure 5. Connecting the AC/DC Adapter
5
4

Aerogen®Pro System Instruction Manual 11
The Aerogen Pro 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.
Note: Allow a minimum of four hours for the internal battery to fully
recharge.
Note: To ensure uninterrupted operation of the Aerogen Pro, 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.
6

12 Aerogen®
Installation for use with a Ventilator
Connection to a Breathing Circuit
1. For adult breathing circuits, connect the nebulizer with adult T-piece
into the inspiratory limb of the breathing circuit before the patient Y
(Figure 6).
Figure 6. Connecting the Aerogen Pro to an adult breathing circuit
Note: Figure 6 shows adult configuration only
For pediatric breathing circuits, connect the nebulizer with the
pediatric T-piece into the inspiratory limb of the breathing circuit
before the patient Y (Figure 7).
Figure 7. Connecting to a 12 mm I.D. pediatric breathing circuit

Aerogen®Pro System Instruction Manual 13
Figure 8. Alternative pediatric breathing circuit using 12 mm Male/12 mm
Female T-piece
Alternatively connect the nebulizer with the pediatric T-piece and the
adapters approximately 30 cm (12 in.) back from the patient Y (Figure
7). Alternatively connect the nebulizer with the 22F/10F/10M T-piece 30
cm (12 in.) back from the patient Y (Figure 8).
2. Always perform a leak test of the breathing circuit after inserting or
removing the nebulizer. Follow ventilator manufacturer instructions for
performing a leak test.
3. Use the universal mounting bracket to attach the controller to an IV
pole or bed rail in either a vertical or horizontal orientation (Figure 9). Do
not over-tighten knob.
Where a standard equipment mount is available, use the equipment
mount adapter to support the controller (Figure 9).

14 Aerogen®
Controller and Vertical
Universal Mounting Bracket
Controller and Horizontal
Universal Mounting Bracket
Equipment
Mount Adapter
Standard
Equipment Mount
Figure 9. Aerogen Pro controller and universal mounting bracket
configurations
Warnings
• Always maintain the nebulizer in a vertical orientation (with the filler cap
uppermost) while in the patient circuit (Figures 6, 7, & 8). This orientation
prevents condensate from blocking the nebulizer and ensures proper
nebulization. Always visually inspect the nebulizer prior to placing
in the ventilator circuit to assure that no secretions are blocking the
Aerogen Vibronic®aerosol generator.
• When removing the nebulizer from the patient circuit always replace
the T-piece plug to maintain circuit pressure.
• 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
nebulizer and patient airway.

Aerogen®Pro System Instruction Manual 15
Adding Medication
•Open the filler cap tab on the nebulizer.
•Use a pre-filled ampoule or syringe to add medication into the filler port
of the nebulizer (Figure 10).
•Close the filler cap tab.
Warning: To avoid damage to the nebulizer, do not use a syringe with a
needle.
The maximum capacity of the nebulizer is 10 mL. Do not fill the nebulizer
beyond the maximum fill indication point (Figure 10). The underside of the
filler cap represents maximum fill indication point.
Figure 10. Filling the nebulizer with a pre-filled ampoule
Note: Medication can be added in this manner during nebulization. This
does not interrupt nebulization or ventilation.
Max. fill
indication
point

16 Aerogen®
Nebulization
For doses less than or equal to 3 mL.
1. To start a 15 Minute nebulization cycle, add the medication and press
and release the blue On/Off power button (Figure 2). The green 15 Min.
indicator lights to indicate that the 15 Minute nebulization cycle is in
progress.
For doses greater than 3 mL.
2. To start a 30 Minute nebulization cycle, add the medication and press
and hold the blue On/Off power button for at least three seconds. The
green 30 Min. indicator lights to indicate that the 30 Minute nebulization
cycle is in progress.
3. To stop the nebulizer at any time, press the On/Off power button. The
indicator turns off to indicate that nebulization has stopped.
Note: When delivering a dose greater than 3 mL, select the 30 Minute
cycle.

Aerogen®Pro System Instruction Manual 17
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). Contact your sales
representative for ordering information.
1. When using a mask, connect the vented elbow, mask elbow and mask
to the nebulizer by firmly pushing the parts together.
2. Rotate the vented elbow to suit the position of the patient (Figure 11).
Figure 11. Connecting to a mask
Warning: To ensure correct nebulization, maintain the nebulizer in a
vertical orientation (Figure 11).
Use with a Mouthpiece
The Aerogen Pro works with any standard ISO 22 mm nebulizer mouthpiece
inserted into the adult T-piece.
Figure 12. Connecting to a mouthpiece
Patient Upright
Patient Reclined
Face Mask
Elbow
Vented
Elbow
Patient Upright
Patient Reclined
Face Mask
Elbow
Vented
Elbow

18 Aerogen®
When using a mouthpiece, connect the nebulizer to the T-piece as shown
in Figure 3 and then connect the T-piece to the mouthpiece by pushing the
parts firmly together (Figure 12).
Warning: To ensure correct nebulization, maintain the nebulizer in a
vertical orientation (Figure 12).