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NOTE:
● Use only the parts listed above that are distributed by
ForaCare; use of other parts may constitute a hazard.
● The item to , are regarded as consumable accesso-
ries. Replace them with new ones if they are still dirty or
obstructed after cleaning.
● The nebulizer kit is for a course of treatment only.
● Expected service life of the main unit is 1 year.
Adults / Children Masks (optional)
Cap
Spray Nozzle
Medicine Cup
Mouthpiece
Nebulizer Kit (assembly of items
to )
Main Unit
Air Hose
Cleaning Steps
1. Pull out the mouthpiece or
mask ( ), and detach the
nebulizer kit from the main
unit ( ).
4. Attach the mouthpiece (or mask) to
the cap ( ). You can directly
connect the nebulizer kit to the
main unit ( ), or connect the air
hose to the nebulizer kit ( ) and
the main unit ( ) if needed.
5. Close your lips around the
mouthpiece and press the power
button to activate the nebulizer.
Hold the main unit vertically
during your treatment. Never lie
down while using the nebulizer.
6. Inhale slowly and deeply, and breathe out naturally. Inhalation
should be stopped when the medicine has been fully used.
7. After treatment, press the power button to turn off the device
and clean as directed in “CLEANING AND MAINTENANCE”.
311-7015700-003
Version 2.0
2022/12
NBL300 Series
Compressor Nebulizer
Operation Instructions
Read instruction before use.
Distributed by ForaCare, Inc.
893 Patriot Drive Suite D
Moorpark, CA 93021 USA
Products made in Taiwan
Toll Free: 1-888-307-8188
(8:30 am-5:00 pm PST, Mon.-Fri.)
For assistance outside of these hours,
please contact your healthcare
professional.
www.foracare.com
DEAR SootheNeb NBL300g OWNER:
Thank you for purchasing the SootheNeb NBL300g Compressor
Nebulizer. This instruction provides important information to help
you use the system properly. Before using this product, please
read the following contents thoroughly and carefully.
The nebulizer accessories and power plug (adapter) can be
purchased separately. If you have other questions regarding this
product, please contact the place of purchase or call the
Customer Service Line at 1-888-307-8188 (8:30 am-5:00 pm
PST, Mon.-Fri.). For assistance outside of these hours, please
contact your healthcare professional.
INTENDED USE
SootheNeb NBL300g Compressor Nebulizer is designed to
provide a compressed air source to aerosolize physician-pre-
scribed liquid medication when used in combination with the
packaged nebulizer accessories, except for Pentamidine. For
reasons of hygiene, the packaged nebulizer accessories are
intended for single use by single patient. SootheNeb NBL300g
Compressor Nebulizer is intended for use with children and adult
patients in the homecare settings.
Caution: Federal law restricts this device to sale by or on the
order of a physician.
IMPORTANT INFORMATION ABOUT INHALATION THERAPY
The device is ideally suitable for inhalation at home or when
travelling. It guarantees highly effective, fast-acting inhalation
treatment for children and adult patients.
Carry out inhalation in a quiet and relaxed state, and inhale
slowly and deeply, so that the medication can penetrate into the
fine, deep bronchial tubes. Exhale normally.
ITEMS SUPPLIED AND DESCRIPTIONS OF PARTS
Before you start to use the SootheNeb NBL300g Compressor
Nebulizer, please check if the following items are included in the
package.
SPECIFICATIONS
Model No.: SootheNeb NBL300g
Dimension & Weight: 99.1 mm x 81.4 mm x 246.4 mm, 305g
Charger output power: 5V (volts) / 2A (amps), USB Type C
Battery: Li-Polymer, non-removable
IP classification: IP22
Mode of operation: 30 mins on/ 30 mins off
Nebulization Rate: ≥ 0.25 ml/min
Medication Capacity: 10ml
MMAD: 3 microns
Power consumption: 7W
Noise level: 60 dBA
Compressor Pressure Range: 13 to 20 Psi
Operating Pressure Range: 5 to 10 Psi
Maximum Flow Rate: ≥3 LPM (I/min)
Aerosol Output: 1.17 ± 0.13 (ml)*
Aerosol Output Rate: 0.35 ± 0.04 (ml/min)**
Operating conditions: 41°F to 104°F (5°C to 40°C), 15% to 93%
relative humidity, 700 hPa to1060 hPa
Storage conditions: -13°F to 158°F (-25°C to 70°C), 10% to 95%
relative humidity
*：Continue the treatment until the medicine cup is empty or the
mist stops.
**：The treatment time for aerosol output rate is 1 min.
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4
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2
2
4
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4
5
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15
16
USB Type C Cable
Air Opening
Air Inlet
Power Button
4G Connection Indicator
Power Button Indicator
Battery Compartment
USB Type C Port (for recharge)
NOTE:
Please contact your dealer or Customer Service Line for
assistance with any other difficulties.
Notice what can be immersed (left) and cannot be
immersed (right) in the water.
IMPORTANT SAFETY PRECAUTIONS
● Use the equipment only for its intended use as described in
this instruction. Do not use attachments not recommended by
the manufacturer.
● Use the equipment with medications only under the instruction
of your physician.
● Do not use the equipment if it has any damaged parts, or it
has fallen into water.
● To use the equipment for the first time, or after storing it for an
extended period, be sure to clean all necessary parts as
described in the cleaning instructions.
● Do not use while bathing.
● The unit should not be left unattended while plugged in or
turned on.
● Keep the unit out of reach of small unsupervised children. The
small parts detached from the device may result children
choking from inhaling or swallowing.
● The accessible materials used in the device will not cause the
potential allergic reactions to skin.
● Do not try to modify the device to prevent any danger.
● Do not place the device in liquid, nor put it where it could fall
into liquid. If the device becomes wet, unplug the device
before touching it.
● Do not use the device if it is not working properly, or if it has
suffered any damage.
● Do not subject the nebulizer to any impact and do not drop it.
● After a period of no use, and after every use, please clean the
main unit.
● Do not expose the nebulizer to direct sunlight, high tempera-
tures or humidity.
START YOUR TREATMENT
Before Use
● Ensure that all parts are clean and dry.
● Before starting treatment, talk to your physician about the
duration, dosage and frequency of use of the nebulizer.
● The device is designed for an intermittent use: 30 minutes ON
/ 30 minutes OFF.
● Do not remove the nebulizer kit from the main unit during
nebulization.
● Pour the distilled water (2 - 5 ml) into the medicine cup. Press
the power button to turn on the device, check if the nebuliza-
tion is taking place properly. Then, press the power button to
turn off and discard any remaining water.
● The prescribed volume of the drug should be adhere to.
● The device does not heat up the medicine cup during opera-
tion, so there is no loss of solution due to evaporation.
How to Use
● Before first use, pull out the insulation
mylar embedded in the battery
compartment and recharge the main
unit for 5 hours. Suggestion for
using 5V / 2A power plug for
recharge.
● Once the nebulizer is plugged into the
power plug at any time, it will go into
recharge mode and stop nebulization.
1. Align the tab of the spray
nozzle with the notch of the
cap and assemble.
2. Add the appropriate amount
of medication to the medicine
cup, as directed by your
physician. Do not exceed
the line marked “MAX”.
3. Assemble the nebulizer kit.
● Turn clockwise, and the
junction of the nebulizer kit
will become one full circle.
● Align and insert the
assembled cap on the
medicine cup.
CLEANING AND MAINTENANCE
Please clean your device after each use according to the instruc-
tions below.
Before Cleaning
Make sure that the nebulizer is turned off before disassembly.
TROUBLESHOOTING
Maintenance for Storage
1. Always handle your nebulizer with care.
2. Keep your nebulizer out of children’s reach. The device may
contain small parts that can be swallowed.
3. If you store your nebulizer, do not bend the air hose.
4. If you store your nebulizer, keep it in the following environmen-
tal range:
a) Temperature: -13°F to 158°F (-25°C to 70°C),
b) Relative humidity: 10% to 95%
5. If possible, store your nebulizer in a well-ventilated room.
Disposal
Dispose of the device, components and optional accessories
according to your local regulations.
2. Turn couterclockwise, and
depart the cap with spray
nozzle from the medicine
cup.
4. Rinse the mouthpiece, medicine cup,
spray nozzle and cap thoroughly with
running water.
*Use clean cloth only to wipe the
masks.
*Do not use brushes and thin, sharp
objects (i.e., pins, needles, etc.) to
clean out the clog in the gap.
*Once the mouthpiece and nebulizer
kit are dirty or clogged after
rinsing, immerse them in water.
5. Shake off excess water,
and left them air dry.
6. Use clean cloth to wipe the
outer casing of the main unit
and air hose, then let them air
dry.
3. Take the spray nozzle and
cap apart.
1
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3
Press and hold the power button
for 5 seconds in standby mode.
Press the power button during
nebulization.
Flashing yellow and turning off
automatically in 10 seconds.
Initiate the 4G
connection
Data upload failed
The indicator change from flashing
blue to solid blue.
Press the power button during 4G
connection. Flashing blue turns
quicker and fades away in 8
seconds, then the nebulizer turns off.
4G connection
succeeded
Forced shutdown 4G
connection
Solid blue and turning off automatically.
Data upload
completed.
Message Probable Cause Solution
LED INDICATORS
LED Indicator
4G Power Nebulizer Status
Ready for use /
Standby mode
Nebulization mode.
Low battery
Recharge the battery
First time activate the
nebulizer.
The nebulizer is on standby,
ready to start at any time.
Press the power button to activate
the nebulizer.
Battery recharge is in progress.
The battery is fully recharged.
The nebulizer is functional, but it is
time to recharge.
The battery is too low. Plug in the
power plug to recharge.
Pull out the mylar. Both 4G and
Power indicators will light up
simultaneously and change
color in sequence as shown.
Description
The device does not
work or the device is
on but nebulizes
weakly.
The device is on but
does not nebulize.
The nebulizer kit does not
assemble well.
Re-assemble the nebulizer
kit.
Plug in the power plug to
recharge the main unit. The
nebulizer will not activate
while charging.
Remove any bend or kink in
the air hose.
Place the spray nozzle in its
correct position.
The battery is getting too
low.
The spray nozzle does
not place in its position.
Add the appropriate amount
of medicine prescribed by
your physician to the
medicine cup.
No medicine is left.
Compressor switch is off.
Air hose is bent.
Turn the switch on.
Plot of cumulative size distribution of results for particle size
Cumulative Fraction (%)
Mean Mass Fraction (%)
AeroDynamic Diameter (µm)
0
0.1 110 100
20
40
60
80
100
0
10
30
20
40
50
individual tests
mean
The device has been certified to meet the electrical and safety
requirements of: IEC 60601-1, IEC 60601-1-2.
>10s
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1
2
3
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5
6
7
8
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11
12
14
13
15
16
9
2
1
Electromagnetic environment-guidance Emission test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations / flicker emissions IEC
61000-3-3
Group 1
Class B
Class A
Compliance
Compliance
Manufacturer’s declaration-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
The device is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
used for domestic purposes.
Electromagnetic environment-guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Compliance
level
IEC 60601 test levelImmunity test
Manufacturer’s declaration-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that of a typical home and
professional healthcare environment.
Mains power quality should be that of a typical home and
professional healthcare environment.
The device power frequency magnetic fields should be at
levels characteristic of a typical location in a typical home
and professional healthcare environment.
Mains power quality should be that of a typical home and
professional healthcare environment. If the user of the
device requires continued operation during power mains
interruptions, it is recommended that the device be
powered from an uninterruptible power supply or a battery.
Electrical fast
transient / burst IEC
61000-4-4
Surge IEC
61000-4-5
Power frequency
(50, 60 Hz)
magnetic field IEC
61000-4-8
Voltage Dips, short
interruptions and
voltage variations on
power supply input
lines IEC 1000-4-11
Contact: ±8 kV
Air±2 kV, ±4 kV, ±8
kV, ±15 kV
±2kV for power
supply lines
Not applicable
±0.5kV,±1kV line(s)
to line(s)
Not applicable
30 A/m
50, 60 Hz
Voltage dips:
0% UT; 0,5 cycle
0% UT; 1 cycle
70% UT; 25, 30
cycles
Voltage
interruptions:
0% UT; 250, 300
cycle
Contact: ±8 kV
Air±2 kV, ±4 kV, ±8 kV, ±15
kV
±2kV for power supply lines
±1kV for input/output lines
±0.5kV, ±1kV line(s) to line(s)
±0.5kV, ±1kV, ±2kV line(s) to
earth
30 A/m
50, 60 Hz
Voltage dips:
0% UT; 0,5 cycle
0% UT; 1 cycle
70% UT; 25/30 cycles
Voltage interruptions:
0% UT; 250/300 cycle
NOTE UT is the a.c. mains voltage prior to application of the test level.
Separation distance according to frequency of transmitter
m
0,01
0,1
1
10
100
0,12
0,38
1,2
3,8
12
0,12
0,38
1,2
3,8
12
0,23
0,73
2,3
7,3
23
Rated maximum output power
of transmitter
W150 kHz to 80 MHz
d =1,2√p
80 MHz to 800 MHz
d =1,2√p
800 MHz to 2,7 GHz
d =2,3√p
Recommended separation distance between
portable and mobile RF communications equipment and the device
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the
user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the
communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
385 380 – 390 TETRA 400
Pulse
modulation b)
18 Hz
1,8 0,3 27 27
710
745
780
704 – 787 LTE Band 13,
17
Pulse
modulation b)
217 Hz
0,2 0,3 9 9
5240
5500
5785
5100 – 5800 WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2 0,3 9 9
810
870
930
800 – 960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
2 0,3 28 28
2450 2400 – 2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz 2 0,3 28 28
1720
1845
1970
1700 – 1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation b)
217 Hz
2 0,3 28 28
450 430 – 470 GMRS 460,
FRS 460
FM c)
±5 kHz deviation
1 kHz sine
2 0,3 28 28
Test
frequency
(MHz)
Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Compliance LEVEL
(V/m)
Band a)
(MHz)
Service a) Modulation b)
Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or
ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual
modulation, it would be worst case.
Electromagnetic environment-guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Compliance
level
IEC 60601 test levelImmunity test
Manufacturer’s declaration-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Portable and mobile RF communications equipment
should be used no closer to any part of the device
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
d = 1,2 √p
d = 1,2 √p 80MHz to 800 MHz
d = 2,3 √p 800MHz to 2,7 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Interference may occur in the vicinity of equipment
marked with the following symbol:
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM and amateur
radio bands between 0,15
MHz and 80 MHz
80 % AM at 1 kHz
10 V/m:
80 MHz – 2,7 GHz
80% AM at 1 kHz
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM and amateur
radio bands between 0,15
MHz and 80 MHz
80% AM at 1 kHz
10 V/m:
80 MHz – 2,7 GHz
80% AM at 1 kHz
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
FEDERAL COMMUNICATIONS COMMISSION (FCC) STATE-
MENT 15.21
You are cautioned that changes or modifications not expressly
approved by the part responsible for compliance could void the
user’s authority to operate the equipment.
15.105(b)
Federal Communications Commission (FCC) Statement
This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to part 15 of the FCC
rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communi-
cations. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can
be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of
the following measures:
● Reorient or relocate the receiving antenna.
● Increase the separation between the equipment and receiver.
● Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
● Consult the dealer or an experienced radio/TV technician for
help.
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions:
1. This device may not cause harmful interference and
2. This device must accept any interference received, including
interference that may cause undesired operation of the device.
FCC RF Radiation Exposure Statement:
1. This transmitter must not be co-located or operating in
conjunction with any other antenna or transmitter.
2. This equipment complies with FCC RF radiation exposure
limits set forth for an uncontrolled environment. This equip-
ment should be installed and operated with a minimum
distance of 20 centimeters between the radiator radiation
source and your body.
ADDITIONAL INFORMATION
Particle Size Delivery Test according to EN13544:2007
The mass median aerodynamic diameter (MMAD), geometric
standard deviation (GSD), respirable fraction (%, 0.5-5 μm), and
particle size distribution of the particles generated from SootheN-
eb NBL300g Compressor Nebulizer are determined by laboratory
testing conducted with a cascade impactor method according to
the European Standard for nebulizers (EN 13544-1:2007).
Three different drugs were used in the testing to represent three
different drug classes: Ipratropium bromide (anti-cholinergic
bronchodilator), Ventolin (as known as albuterol, a beta-agonist
bronchodilator) and Cromolyn sodium (anti-inflammatory). The
dose of each drug that used at the beginning of the cascade
impactor testing was:
● Ipratropium: 500 ug / 2 mL
● Ventolin: 5000 ug / 2.5 mL
● Cromolyn: 8000 ug / 2 mL
The test had involved three runs each of three separate device
samples tested with three classes of drugs. The durations of
each sample collecting by cascade impactor is about 1 - 3 mins
to allow for maximum deposit on each stage without overloading.
The result summary of the test is shown in Table 1, CV (%) of
repeatability was less than 5%.
Features
Features
Total output mass (μg)
Respirable Mass (μg, 0.5-5 μm)
Coarse particle Fraction (%)
(> 4.7 μm)
Fine particle Fraction (%)
(< 4.7 μm)
Ultra-fine particle Fraction (%)
(< 1 μm)
Device sample I.
MMAD (μm)
Mean C.V. (%) ≤5%
Table 1 Results of the repeatability test for SootheNeb NBL300g
Compressor Nebulizer.
● I.B. = Ipratropium bromide
● V. = Ventolin
● C.S. = Cromolyn sodium
● MMAD (μm) = mass-median aerosol diameter, the diameter
above and below which lies 50% of the mass of the particles.
● GSD= Geometric standard deviation
● Respirable fraction (%, 0.5-5 μm) = Respirable mass (μg)/
Particle mass collected by the cascade impactor (μg) x 100%
The test result of device sample I with three classes of drugs
each in three runs is provided in Table 2 shown more informa-
tion, including the total dose delivered, respirable mass (0.5-5 μ
m), course particles fraction (>4.7 microns) (%), fine particles
fraction (<4.7 microns) (%), and extra-fine particles fraction (<1
micron) (%).
Table 2 Summary of the test results for device sample I.
Ipratropium bromide – 2.22
Ventolin – 2.98
Cromolyn sodium – 3.81
I.B. – 4.05
V. – 1.02
C.S. – 0.52
I.B. – 2.96
V. – 2.47
C.S. – 2.92
I.B. – 1.09
V. – 0.49
C.S. – 1.2
Ipratropium bromide – 2.47
Ventolin – 2.63
Cromolyn sodium – 2.42
Geometric Std.
Dev. (GSD)
Respirable Fraction
(%, 0.5-5 μm)
Ipratropium bromide – 83.2
Ventolin – 71.5
Cromolyn sodium – 62.4
Ipratropium bromide – 326.5
Ventolin – 1040.4
Cromolyn sodium – 1514.1
Ipratropium bromide – 106.8
Ventolin – 194.5
Cromolyn sodium – 246.5
Ipratropium bromide – 19.22
Ventolin – 31.19
Cromolyn sodium – 40.84
Ipratropium bromide – 80.78
Ventolin – 68.81
Cromolyn sodium – 59.16
Ipratropium bromide – 17.92
Ventolin – 11.71
Cromolyn sodium – 4.47
The ANOVA statistical analysis of the data from the performance
test has been applied in the data analysis. Results show that
there is no significant difference (p > 0.05) between the mass
size distributions of the medicine particles generated by the
proposed device and a legally marketed device (predicate
device).
In conclusion, the performance test results support the specifica-
tions of SootheNeb NBL300g Compressor Nebulizer, which has
mass-median aerosol diameter (MMAD) less than 5 μm and
respirable fraction range from 60% to 80% depends on the drug
type.
/