Aerogen Aeroneb Pro User manual

Instruction Manual

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Aeroneb®Professional
Nebulizer System
Instruction Manual

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This page has been intentionally left blank

Aeroneb®Professional Nebulizer System Instruction Manual i
Table of contents
Introduction..............................................................................1
System description.............................................................2
Warnings............................................................................4
Warnings............................................................................5
Electromagnetic susceptibility............................................6
Warnings............................................................................7
Symbols .............................................................................8
Warranty...........................................................................12
Life of Product..................................................................12
Assembly and Installation .....................................................13
Recharging the Battery....................................................15
Installation for use with a ventilator..................................16
Installation for use with a mask........................................20
Installation for use with a mouthpiece..............................22
Adding medication ...........................................................23
Nebulization ..........................................................................25
Functional test.......................................................................27
Cleaning, disinfection and sterilization..................................28
Troubleshooting ....................................................................34
Order numbers......................................................................37
Specifications........................................................................39
Physical............................................................................39
Environmental..................................................................39
Performance ....................................................................40
Appendix 1 EMC Tables .......................................................43

ii Aeroneb®Professional Nebulizer System Instruction Manual
List of Figures
Figure 1: Aeroneb Pro.............................................................2
Figure 2: Aeroneb Pro controls and indicators......................10
Figure 3: Connecting nebulizer unit to T-piece.....................13
Figure 4: Connecting control module and nebulizer unit ......14
Figure 5: Connecting the AC/DC adapter.............................15
Figure 6: Connecting to an adult breathing circuit ................17
Figure 7: Connecting to a pediatric breathing circuit ............17
Figure 8: Connecting to a neonatal breathing circuit ............17
Figure 9: Alternative neonatal breathing circuit
using neonate T-piece...........................................18
Figure 10: Control module and universal mounting bracket
(vertical)................................................................19
Figure 11: Control module and universal mounting bracket
(horizontal) ...........................................................19
Figure 12: Equipment mount adapter ...................................19
Figure 13: Connecting to a mask..........................................21
Figure 14: Connecting to a mouthpiece................................22
Figure 15: Filling the nebulizer unit with
a pre-filled ampoule..............................................23
Figure 16: Maximum fill indication point................................24
Figure 17: Starting and stopping nebulization.......................26
List of Tables
Table 1: Aeroneb Pro symbols................................................8
Table 2: Aeroneb Pro controls and indicators.......................11
Table 3: Aeroneb Pro troubleshooting ..................................34
Table 4: Aeroneb Pro parts list .............................................37

Aeroneb®Professional Nebulizer System Instruction Manual 1
Introduction
The Aeroneb®Professional Nebulizer 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.
Aeroneb®Pro is suitable for use by neonate, pediatric to adult
patients as described in this manual. It incorporates the
Aerogen Vibronic®Aerosol Generator.
Aeroneb®Pro is intended for hospital use only. It 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 control module 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 Aeroneb®Professional Nebulizer 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 Aeroneb®Professional Nebulizer
System is suitable for use in adult, pediatric and neonate
patients.

2 Aeroneb®Professional Nebulizer System Instruction Manual
System description
The Aeroneb Professional Nebulizer System (Figure 1)
includes the following components: nebulizer unit (Aerosol
Generator and filler cap), T-piece (adult) with plug, control
module, control module cable, AC/DC adapter, and mounting
brackets.
Figure 1: Aeroneb Pro
Filler Cap
1. Nebulizer unit with filler cap
2. T-piece (adult) with plug
3. Control module
5. AC/DC adapter
7. Equipment mount adapter
6. Universal mounting bracket
4. Control Module Cable
T-piece plug

Aeroneb®Professional Nebulizer System Instruction Manual 3
1. The nebulizer unit holds up to 10 mL of liquid
medication. The nebulizer unit is translucent to allow
visual monitoring of medication levels and
aerosolization. When the nebulizer unit is connected
into the breathing circuit, the filler cap can be opened
or removed from the nebulizer unit without causing
loss of circuit pressure.
Within the nebulizer unit is an 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 unit 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 control module can operate from the AC/DC
adapter or the internal rechargeable battery. The
control module includes an On/Off power button and
sockets for the control module cable and the AC/DC
adapter. The control module also includes indicators
for nebulization cycle selection (15 or 30 minutes),
battery charge status and fault conditions.
6. A universal mounting bracket clamps the control
module to standard IV poles and medical rail systems.
7. An equipment mount adapter mounts the control
module on standard equipment mounts.
Pediatric T-piece, neonate adapters, mask adapter kits, elbow
connectors and mouthpiece are sold separately.

4 Aeroneb®Professional Nebulizer System Instruction Manual
Warnings
Read and study all instructions before using Aeroneb Pro.
Only 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 27) according to the instructions in this manual before
first use and between patients.
Do not place the control module 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 a flammable anesthetic mixture
combined with air or with oxygen or nitrous oxide.
Do not use to aerosolize alcohol-based medications, which
can ignite in oxygen-enriched air under high pressure.
To avoid the risk of fire, do not use in the presence of
flammable substances.
Do not modify this equipment without the authorization of the
manufacturer.

Aeroneb®Professional Nebulizer System Instruction Manual 5
Warnings
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 unit 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 unit.
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 Aeroneb Pro nebulizer
system sales representative.
Disconnect nebulizer unit from control module before cleaning.
Do not immerse or autoclave the control module 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.

6 Aeroneb®Professional Nebulizer System Instruction Manual
To avoid mechanical or electrical damage, do not drop the
nebulizer unit or the control module.
Do not use in the presence of devices generating high
electromagnetic fields such as magnetic resonance imaging
(MRI) equipment.
The Aeroneb Pro control module 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.
Electromagnetic susceptibility
This device meets the requirements of the Electromagnetic
Compatibility (EMC), pursuant to the Collateral Standard,
IEC/EN 60601-1-2 which addresses EMC in North America,
Europe and other global communities. This includes immunity
to radio frequency electric fields and electrostatic discharge, in
addition to the other applicable requirements of the standard.
Compliance with EMC standards does not mean a device has
total immunity; certain devices (cellular phones, pagers, etc.)
can interrupt operation if they are used near medical
equipment. Follow institutional protocol regarding the use and
location of devices that could interfere with medical equipment
operation.
Note: This device is classified as Class II Type BF medical
electrical equipment and the device complies with specified
safety levels for electrical isolation and leakage current. The
AeronebPro AC/DC adapter has no connection to earth
ground because the necessary level of protection is achieved
through the use of double insulation.

Aeroneb®Professional Nebulizer System Instruction Manual 7
Warnings
Only use the Aeroneb Pro nebulizer with components
specified in the Instructions for Use. Use of the
Aeroneb Pro nebulizer with components other than
those specified in the Instructions for Use may result in
increased emissions or decreased immunity of the
Aeroneb Pro nebulizer system.
Do not use the Aeroneb Pro adjacent to or stacked
with other equipment. If adjacent or stacked use is
necessary, the device should be observed to verify
normal operation in this configuration.
The Aeroneb Pro needs special precautions regarding
electromagnetic compatibility (“EMC”) and must be
installed and put into service according to the EMC
information provided in the Instructions for Use.
Portable and mobile radio frequency (“RF”)
communication devices can disrupt medical electrical
equipment.
Refer to appendix 1 for EMC tables as per IEC / EN 60601-1-2

8 Aeroneb®Professional Nebulizer System Instruction Manual
Symbols
The following symbols apply to Aeroneb Pro and appear on
the back of the control module and on the packaging:
Table 1: Aeroneb Pro symbols
Symbol
Meaning
AP-YYXXXX
Serial number, where YY is the year of
manufacture and XXXX is the serial number.
Attention, consult accompanying documents.
Degree of protection against dripping water.
Class II equipment per IEC/EN 60601-1.
Type BF equipment per IEC/EN 60601-1.
On/Off power button (standby).
Timer selection (to select the 15 minute or
30 minute nebulization cycles).
Control Module Input –DC voltage.
~
Control Module Output –AC voltage.
Output.

Aeroneb®Professional Nebulizer System Instruction Manual 9
Table 1: Aeroneb Pro symbols
Symbol
Meaning
Does not contain natural rubber latex.
Battery status indicator.
Fragile, handle with care.
Transient storage temperature limitations
–20 C to +60 C.
Keep dry.
This device complies with the requirements
of the Medical Devices Directive
(93/42/EEC).
Consult Instructions for Use.
Manufacturer.
Refer to instruction manual/booklet.
Classified by TUV with respect to electric
shock, fire and mechanical hazards.
Quantity (Number of units contained in
package).
+60C
-20C

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Controls and indicators
Figure 2: Aeroneb Pro controls and indicators
Fault Indicator
On/Off Power
Timer Selection
Battery Status
Indicator
9V D.C. Input
Control Module
Cable Input
15 Min. Indicator
30 Min. Indicator

Aeroneb®Professional Nebulizer System Instruction Manual 11
Table 2: Aeroneb Pro controls and indicators
Control/indicator
Function
15 Min. indicator
Green (steadily lit) = 15 minute
nebulization cycle on
Green (flashing) = Low battery power
Nebulizer unit 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 unit automatically powers
off after 30 minutes have elapsed
Fault indicator
Amber = Faulty electrical connection
On/Off power
button
Pressing and immediately releasing
selects the 15 minute nebulization
cycle
Pressing and holding for at least three
seconds selects the 30 minute
nebulization cycle
Pressing during nebulization turns off
power to the nebulizer
Battery status
indicator
Green = Battery fully charged
Amber = Battery charging
No light = Battery in operation

12 Aeroneb®Professional Nebulizer System Instruction Manual
Warranty
The Aeroneb Pro nebulizer unit is warranted for one year from
date of purchase against defects in manufacturing. The
Aeroneb Pro Control Module and AC/DC Adapter are
warranted for a period of two years from the date of purchase
against defects in manufacturing. All warranties are based on
typical usage.
Life of Product
As with all active electronic components, the Aeroneb Pro
nebulizer unit has a defined life. In the case of the Aeroneb
Pro Controller, the life of the controller unit has been validated
for use for 1460 doses. This is based on a typical product
usage profile over a two year period, including four treatments
per day, 50% of the time.
The life of the Aeroneb Pro nebulizer and components have
been validated for use for 730 doses and 26 autoclave
treatments based on a typical one year usage profile of four
treatments per day and one sterilization per week, where the
device is assumed to be in service for 50% of the time.
The user should note that any use in excess of this may
result in reduced life of the product.

Aeroneb®Professional Nebulizer System Instruction Manual 13
Assembly and Installation
1. Clean and sterilize the nebulizer unit and T-piece(s) as
described in the Cleaning, disinfection and sterilization
section of this manual.
Note: The nebulizer unit and T-piece, as packaged, are not
sterile.
2. Perform a functional test of Aeroneb Pro before use and
between patients as described in the functional test
section of this manual.
3. Insert the filler cap into the opening on the nebulizer unit.
4. Connect the nebulizer unit to the T-piece by pushing the
nebulizer unit firmly onto the T-piece (Figure 3).
Figure 3: Connecting nebulizer unit to T-piece

14 Aeroneb®Professional Nebulizer System Instruction Manual
5. Connect the control module and the nebulizer unit
together using the control module cable (Figure 4).
Figure 4: Connecting control module and nebulizer unit
6. To operate on AC power (the primary mode of operation),
insert the AC/DC adapter connector into the control
module and plug the adapter into an AC power source
(Figure 5).
7. Aeroneb 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 control module 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 Aeroneb Pro,
secure both the AC/DC adapter cable and the control module
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.
Fig 3