1. The above-named accessories are consumable items. Please replace with new
accessories when they become dirty and obstructed. Do not share the accessories with others.
2. Use only the accessories and parts from ForaCare , Inc.
NOTE
Note: If vapor is slow, remove mesh cap and
shake off the residual water inside the mesh cap.
Be careful
NOT
to touch the mesh itself.
NOTE
Distributed by ForaCare, Inc.
893 Patriot Dr., Suite D
Moorpark, CA 93021 USA
Products made in Taiwan
Toll Free: 1-888-307-8188
(8:30am-5:00pm PST, Monday-Friday)
For assistance outside of these hours, please contact your healthcare professional.
Read instructions before use.
Maintenance for Storage
1. Cover the mesh cap with unit lid (refer to Description of Part #1) to prevent the accumulation of dust.
2. Always handle your nebulizer with care.
3. Disconnect the power plug from the wall outlet when not in use.
4. Keep your nebulizer out of children’s reach.
5. If you store your nebulizer, try to keep it in the following environmental ranges:
a) Temperature: -13°F to 158°F (-25°C to 70°C)
b) Relative humidity: 10% to 95%
6. If possible, store your nebulizer in a well-ventilated room.
7. Remove the batteries when the nebulizer is not in use for an extended period of time.
1.
Use the AC Adapter (Input: AC, 100-240V & Output: DC, 6V) provided by ForaCare, Inc. DO
NOT use any other AC Adapters.
2. Discard the used batteries according to your local regulations.
NOTE
To replace the battery, make sure that the nebulizer is turned off.
1. Press the buckle on the battery cover and lift up to remove the cover.
2. Remove the used batteries. Insert the new ones. Correctly align the polarities (+ and -) with battery
indication marks on the device.
3. Close the battery cover by pressing down firmly until a click is heard.
Battery Replacement
Replace the batteries when the light indicator is red.
Disposal
Dispose of the device, components and optional accessories according to your local regulations.
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 the SootheNeb
NBL100 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 bronchodila-
tor) and Cromolyn sodium (anti-inflammatory). The dose of each drug that used at the beginning of the
cascade impactor testing was:
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 1-3mins 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%.
ADDITIONAL INFORMATION
2. Pour out any remaining medication.
Ipratropium: 500ug/2mL Ventolin: 5000ug/2.5mL Cromolyn: 8000ug/2mL
The test result of device sample I with three classes of drugs each in three runs is provided in Table 2
shown more information, including the total dose delivered, respirable mass (0.5-5 µm), course
particles fraction (>4.7 microns) (%), fine particles fraction (<4.7 microns) (%), and extra-fine particles
fraction (<1 micron) (%).
* 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%
Table 2 Summary of the test results for
device sample I.
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 specifications of SootheNeb NBL100, which
has mass-median aerosol diameter (MMAD) less than 5µm and respirable fraction range from 60% to
80% depends on the drug type.
Symptom
Probable Cause
Solution
The indicator turns red.
The device does not work
when the ON/OFF button is
pressed.
The indicator is green but
the device does not produce
mists or produces small
amounts of mists.
The batteries do not have enough
power to perform.
The mesh cap is covered with dust.
Clean the mesh cap.
If the situation happens again, please
replace with a new mesh cap.
No power.
Check the batteries.
The mesh cap and medication cup are
not assembled properly.
The texture of medicine may be thick.
Check connection between the AC
adapter and the nebulizer.
Re-assemble the mesh cap and
medication cup and twist them well.
Gently shake the medicine well.
No medicine is left.
Add the appropriate amount of
medicine prescribed by your physician
to the medication cup.
Mesh is clogged or dirty.
Repeat the cleaning procedures step 1
to 7.
Replace the batteries immediately.
Features
Device sample I.
Total output
mass (µg)
Respirable
Mass
(µg, 0.5-5 µm)
Coarse particle
Fraction
(%)(> 4.7 µm)
Ipratropium bromide – 438.94µg
Ventolin – 889.56µg
Cromolyn sodium – 911.49µg
Ipratropium bromide – 11.01%
Ventolin – 28.41%
Cromolyn sodium – 27.93%
Fine particle
Fraction (%)
(< 4.7 µm)
Ipratropium bromide – 88.99%
Ventolin – 71.59%
Cromolyn sodium – 72.07%
Ultra-fine
particle Fraction
(%)(< 1 µm)
Ipratropium bromide – 18.58%
Ventolin – 12.58%
Cromolyn sodium – 17.95%
Ipratropium bromide – 86.21µg
Ventolin – 224.3µg
Cromolyn sodium – 160.51µg
TROUBLESHOOTING
The device has been certified to meet the electrical and safety requirements of: IEC 60601-1, IEC 60601-1-2.
Cascade Impactor Testing*:
*The test method and results are shown in “Additional Information”.
Please contact your dealer for assistance with any other difficulties.
NOTE
Drug Name
Ipratropium bromide
1.89µm
2.05
85.6%
2.87µm
2.4
74.6%
2.7µm
2.72
74.7%
Cromolyn sodium
Ventolin
MMAD (micron)
GSD(geometric standard deviation)
Respirable fraction (% mass 0.5- 5µm)
Features
SPECIFICATIONS
Model no.: SootheNeb NBL100
Dimension & Weight: 53(D)mm x 103(H)mm, 83g
Power Source: 2 x AA alkaline batteries
Input: 100~240V, AC
Output: 6V, 1A, DC
Operating conditions: 41°F to 104°F (5°C to 40°C), 15% to 93% relative humidity
Storage conditions: -13°F to 158°F (-25°C to 70°C), 10% to 95% relative humidity
Power consumption: 1.2W
Nebulization rate: 0.25 ml/min
Medication capacity: 5 ml
MMAD: 5 microns
Features
Mean
C.V. (%)
≦
5%.
MMAD (µm)
Geometric
Std. Dev.
(GSD)
Respirable
Fraction
(%, 0.5-5 µm)
Ipratropium bromide – 1.89µm
Ventolin – 2.87µm
Cromolyn sodium – 2.7µm
I.B. – 1.61
V. – 1.25
C.S. – 1.49
I.B. – 2.69
V. – 2.05
C.S. – 1.52
I.B. – 0.43
V. – 0.72
C.S. – 0.41
Ipratropium bromide – 85.6%
Ventolin – 74.6%
Cromolyn sodium – 74.7%
Ipratropium bromide – 2.05
Ventolin– 2.4
Cromolyn sodium – 2.72
Table 1 Results of the repeatability test for
SootheNeb NBL100.
1. Use cotton cloth or paper towel to wipe clean the nebulizer unit (refer to Description of part 6)
2. Let it air dry on a clean paper towel.
Cleaning of Nebulizer Unit
3. Submerge
ONLY
the
Mesh Cap (NOT the medication cup)
in
distilled water
for about 30 seconds.
Then, carefully dry with a clean paper towel.
4. Add a small amount (approximately 1 ml) of
distilled water
into the Medication Cup.
5. Twist the mesh cap back on to the medication cup then
press the on button to nebulize the distilled water for
1 to 2 minutes to remove residual medication.
6. Turn off the device after it's done then remove the medication cap to air DRY on a clean paper towel.
7. Once all components are DRY, assemble device and store in a clean environment.
Distilled
Water
Residual Water
WARNING
Do not wet the medication cup connector and
the connector socket.
