Trudell Medical International AeroEclipse II Mode D'emploi

BAN * Nebulizer
Trudell Medical International
725 Baransway Drive, London, Ontario, Canada N5V 5G4
+1-519-455-4862
info@trudellmed.com www.trudellmed.com
105827-001 C. 2024-06-12. *trade-marks and registered trade-marks of Trudell Medical International (TMI).
†
trade marks and registered trade marks of their respective companies. © TMI 2022, 2024. All rights reserved.
C
G
I
H
F
Part number Quantity Unique device identifier
Single patient – multiple use
For optimum performance
replace after 7 days
Scan or contact Trudell Medical International to obtain
a glossary of the symbols used on packaging and
instructions for use.
105501
A
D
B
J
E
Nebulizer
Nebulizer
Designed and developed in Canada
Australian Sponsor
INTENDED USE
The nebulizer is intended to be used to deliver aerosol
drug to the patient's lungs. It is to be used by infant, child
and adult patients. The patient is to be awake and can
breathe unassisted. The environments of use include
hospitals and clinics. The nebulizer is single patient,
reusable.
Breath actuation only produces aerosol when the patient
inhales. Aerosol is not produced when the patient
exhales or takes a break in treatment. The clinical benefit
is more drug is available to the lungs. Less drug is lost to
the environment.
Caution: Breath actuation delivers drug on
inspiration only. This may result in an increase of the
dosage to the lungs. Health care providers should take
this into consideration with regards to dosage.
If you have concerns regarding the use of the nebulizer,
please speak with your health care provider.
Notes
• The nebulizer must only be used by a person who
understands the instructions for use and can use the
device safely. The treatment must be carried out by a
responsible person if the patient is not able to use the
nebulizer on their own. Infants, children, and persons
with limited capabilities must be supervised.
• The nebulizer is designed to aerosolize solutions and
suspensions.
• Only use with drugs prescribed by a health care
provider.
• Do not use in an anaesthetic or a ventilator breathing
system.
BEFORE EACH USE
Ensure these instructions have been read and are kept
available at all times. Carefully examine the device. If
there is any visible dust or other debris inside, then clean
it. Check inside the EZ Twist* Tubing (F) end for fraying
or debris, clean it out if needed. Replace the nebulizer
and the tubing (F) immediately if they are damaged or
have missing parts.
Warning: Do not leave the nebulizer unattended
with children. Contains small parts that can cause
choking and tubing that can cause strangulation.
INSTRUCTIONS FOR USE
1
Ensure the exhalation valve (B) on the mouthpiece
(A) faces down.
Warning: It is important to prevent exhaled breath
from blowing near the eyes. Refer to the drug product
monograph for more information.
Note: For patients unable to use the mouthpiece,
the nebulizer can be used with a ComfortSeal* Mask.
2
Inhale and exhale through the nebulizer mouthpiece
(A) to verify the movement of the green feedback button
(C) on the top of the nebulizer. The button should move
up and down freely.
Notes:
• To operate the nebulizer in continuous mode
(I), rotate the mode selector (G) clockwise to the
continuous mode position .
• To return the nebulizer to breath actuated mode (H),
rotate the mode selector (G) counterclockwise to
the breath actuated position .
3
Unscrew and remove the top of the nebulizer. Place
prescribed drug into the nebulizer cup (E). Reattach the
top and gently hand tighten.
Note: Keep the nebulizer in an upright position so
the drug does not spill.
4
Attach one end of the tubing (F) to the fitting in
the bottom of the nebulizer and the other end to the
flowmeter or compressed air source. Ensure both ends
are securely attached.
5
Turn on the compressed air source. Set the flowmeter
to 7 to 8 L/min with a compressed air source capable of
delivering 345 kPa (50 psi).
6
Place the mouthpiece (A) in mouth, and inhale slowly
and deeply. As you inhale, the green feedback button
(C) will move into the down position. This indicates the
nebulizer is producing aerosol. Exhale normally. As you
exhale, the green feedback button (C) will move into the
up position. This indicates the nebulizer is not producing
aerosol.
Notes:
• Do not place the lips over the exhalation valve (B)
on the bottom of the mouthpiece (A). Doing so will
prevent the valve from functioning properly.
• Do not cover the inhalation ports (J) on the
nebulizer. Doing so will reduce volume of inhaled air.
• Ensure the nebulizer remains upright for proper
nebulization.
7
Continue to inhale from the nebulizer until it starts
to sputter, or as instructed by your health care provider.
Type
Breath Actuation Operation
Driving Gas
Driving Gas Flow (at nominal 345 kPa (50 psi) pressure
when connected to the nebulizer)
Maximum Pressure for Tubing at 22 °C ± 2 °C Ambient
Conditions
Maximum Fill Volume
Maximum A-Weighted Sound Pressure Level
Mass of Nebulizer (without tubing)
Operating Temperature Limits
Operating Relative Humidity Range
Storage Temperature Range
Storage Relative Humidity Range
Recommended Replacement Period
ISO 27427 PERFORMANCE DATA
Aerosol Output 1
Aerosol Output Rate 1
Percentage of Fill Volume Emitted Per Minute 1
Residual Volume 1
Mass Median Aerodynamic Diameter (MMAD) 2
2
Geometric Standard Deviation (GSD)
2
Particle size % > 5 µm
Particle size % 2 µm to 5 µm 2
Particle size % < 2 µm 2
Respirable Fraction 2 (5 µm and smaller)
1 2 mL fill volume of sodium fluoride 2.5% (M/V) solution. TMI data on file.
2
3 mL fill volume of sodium fluoride 2.5% (M/V) solution. TMI data on file.
Notes
• A suspension and/or high viscosity solution can alter the particle size distribution curve, the mass median
aerodynamic diameter (MMAD), aerosol output and/or aerosol output rate which then can be different from those
disclosed in these instructions.
• Disclosures for nebulizer performance are based upon testing that utilizes adult ventilatory patterns and are likely
to be different from those stated for paediatric or infant populations.
8
Turn off the compressed air source.
Note: Disconnect the tubing (F) from the
compressed air supply after use.
CLEANING
Caution: Follow the cleaning instructions. Failure
to do so may affect drug delivery.
Nebulizer
The nebulizer (excluding the tubing (F)) can be cleaned
after each use.
1
The mode selector (G) should be in the breath
actuated position .
2
Remove the tubing (F) from the bottom of the
nebulizer.
3
Unscrew and remove the nebulizer top (D).
4
Shake out excess drug.
5
Use any of the following methods to clean the
nebulizer.
A Hand Washing
i. Soak the three parts in a mild solution of liquid
dish detergent and lukewarm clean water for about 5
minutes. Agitate gently.
ii. Rinse thoroughly with clean water.
iii. Shake out excess water.
B Sterile Water
i. Thoroughly rinse the three parts in sterile water.
ii. Shake out excess water.
6
Briefly connect the tubing (F) to the bottom of the
nebulizer cup (E) and the compressed air supply to clear
the air pathway.
7
Allow the parts to air dry thoroughly before
reassembling.
8
Reattach the nebulizer top (D), making sure to line up
the white cylinder with the stem of the nebulizer cup (E).
Gently hand tighten until a stop is detected.
9
Reattach the mouthpiece (A) to the nebulizer with
the exhalation valve (B) facing down.
10
After the nebulizer is fully dry and assembled, store
in a clean plastic bag or container.
EZ Twist* Tubing
To remove condensation on the inside of the tubing (F),
connect one end of the tubing (F) to the compressed
air supply. Allow the air to run without the nebulizer
attached. This will force air through the tubing, drying
the inside. To clean the exterior, wipe with a damp cloth.
Allow to air dry thoroughly.
DISINFECTION
The nebulizer (excluding the tubing (F)) can be
disinfected each day.
Follow the cleaning instructions. Do not dry or
reassemble the nebulizer.
1
Use any of the following methods to disinfect the
nebulizer.
A Isopropyl Alcohol
i. Soak the three parts in 70 % isopropyl alcohol for 5
minutes.
ii. Rinse the parts thoroughly with sterile water.
iii. Allow the parts to air dry thoroughly before
reassembling.
B Cidex
†
i. Follow the disinfectant instructions for use.
ii. Allow the parts to air dry thoroughly before
reassembling.
2
After the nebulizer is fully dry and assembled, store in
a clean plastic bag or container.
Notes
• The nebulizer (excluding tubing) can be cleaned and
disinfected up to 28 times.
• No modifications of the nebulizer are permitted.
• The nebulizer parts comply with the relevant
requirements of ISO 27427.
• The materials used for the components may not be
compatible with emulsions. In such cases, information
should be sought from the drug supplier.
• Not made or manufactured with bisphenol A (BPA),
di(2-ethylhexyl) phthalate (DEHP), latex or lead.
• This nebulizer can be disposed of with domestic waste
unless this is prohibited by the disposal regulations
prevailing in the respective member countries.
• Any serious incident that has occurred in relation to
the device should be reported to the manufacturer
and the competent authority of the Member State,
the MHRA or the Saudi Food and Drug Authority, as
appropriate.
Pneumatically powered jet nebulizer
Triggered mechanically (by the patient on inhalation)
by an inhalation flow over 15 L/min
Air
Maximum/Nominal: 8 L/min
Minimum: 7 L/min
345 kPa (50 psi)
6 mL
63 dBA
0.03 kg (0.07 lb)
+15 °C (59 °F) to +40 °C (104 °F)
15 % to 95 % RH
-40 °C (-40 °F) to +60 °C (140 °F)
Ambient to 95 % RH
7 days
At 7 L/min At 8 L/min
14.8 mg 16.1 mg
3.4 mg/min 3.9 mg/min
6.9 % 7.8 %
1 mL 1 mL
3.4 μm
2.3
33 %
40 %
27 %
67 %