Aeroneb Solo User manual
Instruction Manual
Aeroneb® Solo System
Instruction Manual
Part Number: AG-AS3050-EN
Rev. H
© 2010 Aerogen
Table of contents
Introduction 1
System description 2
Warnings 5
Electromagnetic susceptibility 7
Symbols 8
Controls and indicators 10
Warranty 12
Life of Product 12
Assembly and Installation 13
Recharging the Battery 19
Installation for use with a ventilator 19
Installation for use with a mask........................................23
Installation for use with a mouthpiece..............................24
Adding medication 25
Nebulization 26
Functional test 28
Cleaning of Pro-X Control Module 29
Troubleshooting 30
Order numbers 33
Specications 35
Physical 35
Environmental 35
Performance 36
Power 36
Aeroneb® Solo System Instruction Manual iii
List of Figures
Figure 1: Aeroneb® Solo System 2
Figure 2: Aeroneb® Pro -X 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 Aeroneb® Pro-X AC/DC adapter 14
Figure 6: Connecting tubing to the Aeroneb® Solo for
continuous nebulization 17
Figure 7: Connecting to an adult breathing circuit 20
Figure 8: Connecting to a pediatric breathing circuit 20
Figure 9: Connecting to a neonate breathing circuit 21
Figure 10: Alternative neonatal breathing circuit using
neonate T-piece 21
Figure 11: Control module and universal mounting bracket
(Vertical) 22
Figure 12: Control module and universal mounting bracket
(Horizontal) 22
Figure 13: Equipment mount adapter 22
Figure 14: Connecting to a mask...........................................23
Figure 15: Connecting to a mouthpiece.................................24
Figure 16: Filling the nebulizer unit with a pre-lled ampoule 25
Figure 17: Starting and stopping nebulization 27
List of Tables
Table 1: Aeroneb® Pro-X symbols 8
Table 2: Aeroneb® Pro-X controls and indicators 11
Table 3: Aeroneb® Pro-X troubleshooting 30
Table 4: Aeroneb® Solo Parts List 33
iv Aeroneb® Solo System Instruction Manual
Introduction
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The Aeroneb® Solo System is an iteration of the Aeroneb®
Professional Nebulizer System. The indications for use of the
Aeroneb® Professional Nebulizer System are given below. The
Aeroneb® Solo System, which consists of the Aeroneb® Solo
nebulizer and the Aeroneb® Pro-X controller, is a nebulizer
system designed for use with mechanically ventilated patients
to aerosolize physician-prescribed medications for inhalation
which are approved for use with a general purpose nebulizer.
The Aeroneb® Solo nebulizer is for single patient use only and
the Aeroneb® Pro-X controller is for re-use.
The Aeroneb® Solo System is suitable for use with neonate,
pediatric and adult patients as described in this manual. It is a
latex-free system for intermittent and continuous nebulization
that incorporates Aerogen’s OnQ™ Aerosol Generator.
The Aeroneb® Solo nebulizer is designed to operate in-line
with standard ventilator circuits and mechanical ventilators.
It operates without changing patient ventilator parameters and
can be relled without interrupting ventilation.
The Aeroneb® Pro-X control module operates from the AC/DC
adapter and can be operated on its internal rechargeable
battery for up to 45 minutes. 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 nenoate
patients as described in the Instruction Manual.
Aeroneb® Solo System Instruction Manual 1
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System description
The Aeroneb® Solo System (Figure 1) includes the following
components: nebulizer unit (Aerosol Generator and plug),
T-adapter (adult)* Aeroneb® Pro-X control module, control
cable, AC/DC adapter and mounting brackets. (Pedatric &
neonate T-adapters and continuous nebulization tube set are
Sold separately).
1. Nebulizer unit with plug 2. T-piece (Adult)*
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Tim
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3
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.
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3. Control module 4. Control Module Cable
5. AC/DC adapter
Tube Set
7. Universal mounting bracket 8. Equipment mount adapter
Figure 1: Aeroneb® Solo System
6. Continuous Nebulization
2 Aeroneb® Solo System Instruction Manual
Aeroneb® Solo System Instruction Manual 3
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1. The nebulizer unit holds up to 6mL of liquid
medication. The nebulizer unit is clear to allow visual
monitoring of medication levels and aerosolization.
When the nebulizer unit is connected into the
ventilator circuit, the silicone plug can be opened
and closed in between doses without causing loss of
circuit pressure.
Within the nebulizer unit is an OnQ™ 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. The T-piece connections
are standard male and female 22mm conical ports
and connect to standard patient breathing circuits.
Aerogen recommend that the Aeroneb® Solo nebulizer
be used in conjunction with a relevant disposable
T-piece supplied by Aerogen.
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 (30 minutes
or continuous), battery charge status and fault
conditions.
6. The Aeroneb® Solo can be operated continuously
by attaching the continuous nebulization tube set
accessory. The continuous nebulization tube set is
designed for use with a syringe pump for continuous
drug dosing.
............................
7. A universal mounting bracket clamps the control
module to standard IV poles and medical rail systems.
8. An equipment mount adapter mounts the control
module on standard equipment mounts.
4 Aeroneb® Solo System Instruction Manual
Aeroneb® Solo System Instruction Manual 5
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Warnings
Read and study all instructions before using the
Aeroneb® Solo system. Only medical personnel should
operate the device.
Perform functional test prior to use to ensure correct operation
(see page 28).
This is a single patient use device not to be used on more
than one patient to prevent cross infection.
Do not use beyond dened life (see page 12).
During use observe for correct functioning of the nebulizer.
The nebulizer unit and T-piece, as packaged, are not sterile.
Do not autoclave the Aeroneb® Solo nebulizer.
The continuous mode can only be operated from the mains
supply and cannot be operated by battery power.
To ensure correct and safe connection between the nebulizer
and the medication reservoir, trace the medication tube from
the nebulizer back to the medication reservoir to make sure
the medication tube is connected to the correct source.
Do not use a lter or heat-moisture exchanger (HME) between
the nebulizer and patient airway.
Do not wrap the nebulizer cable tightly around any of the
system components.
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 lter in the expiratory limb of a breathing circuit.
Only use physician prescribed solutions that are approved for
use with a general purpose nebulizer.
To ensure optimum drug administration, consult the
drug manufacturer’s instructions regarding suitability for
nebulization.
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Warnings Continued
Do not use in the presence of a ammable 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 re, do not use in the presence of
ammable substances.
To avoid damage to the nebulizer:
• Donotapplyunduepressuretothedomedaperture
plate in the center of the nebulizer.
• DonotpushouttheOnQTM Aerosol Generator.
• Donotuseasyringewithaneedletoadd
medication.
• Donotuseabrasiveorsharptoolstocleanthe
nebulizer unit.
Do not use the Aeroneb® Solo nebulizer with the reusable
connectors available with the Aeroneb® Pro nebulizer.
Aerogen recommend use of the relevant disposable T-pieces
and adapters provided by Aerogen with the Aeroneb® Solo
nebulizer.
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 Aerogen product sales
representative.
Do not immerse or autoclave the control module or AC/DC
adapter.
Use only with components specied by Aerogen.
Do not use or store outside of specied environmental
conditions.
To avoid mechanical or electrical damage, do not drop the
nebulizer unit or the control module.
6 Aeroneb® Solo System Instruction Manual
Aeroneb® Solo System Instruction Manual 7
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Warnings Continued
Do not use in the presence of devices generating high
electromagnetic elds such as magnetic resonance imaging
(MRI) equipment.
The Aeroneb® Pro -X 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.
Follow local laws and recycling plans regarding disposal or
recycling of components, batteries and packaging.
The Aeroneb® Solo nebulizer is designed for use in continuous
mode only when used with the Aeroneb® Pro –X controller.
Do not use the Aeroneb® Pro Nebulizer in continuous mode.
Caution: Federal law restricts this device to sale by or on the
order of a physician
Electromagnetic susceptibility
This device meets the requirements of the Electromagnetic
Compatibility (EMC), pursuant to the Collateral Standard,
EN 60601-1-2 (second edition), which addresses EMC in
North America, Europe and other global communities. This
includes immunity to radio frequency electric elds 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 classied as Class II Type BF medical
electrical equipment and the device complies with specied
safety levels for electrical isolation and leakage current. The
Aeroneb® Solo AC/DC adapter (AG-AP1040-XX) has no
connection to earth ground because the necessary level of
protection is achieved through the use of double insulation.
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Symbols
The following symbols apply to Aeroneb® Pro-X controller
and appear on the back of the control module and on the
packaging:
Table 1: Aeroneb® Pro-X 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 60601-1.
Type BF equipment per IEC 60601-1.This
label applies to the Aeroneb® Solo Nebulizer
only.
On/off power button (standby).
30 (mins.)
8 Aeroneb® Solo System Instruction Manual
30 minute operating mode
Continuous operating mode (International)
8
Control Module Input – DC voltage.
Control Module Output – AC voltage.
Components are latex free
Aeroneb® Solo System Instruction Manual 9
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NON
STERILE
Table 1: Aeroneb® Pro-X symbols
Symbol Meaning
Output
Battery status indicator.
Fragile, handle with care.
Keep dry.
Rx Only
Federal (US) law restricts this device to sale
by or on the order of a physician.
Classied by TUV with respect to electric
shock, re and mechanical hazards.
US
This device complies with the requirements
of the Medical Devices Directive
(93/42/EEC).
Non-Sterile
Consult Instructions for Use
Use by (YYYY-MM)
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