SootheNeb NBL300 Series Compressor Nebulizer Instruction Manual

NBL300 Series
Compressor Nebulizer
Operation Instructions

NBL300 Series Compressor Nebulizer

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-prescribed 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.

1. Adults / Children Masks (optional)
2. Cap
3. Spray Nozzle
4. Medicine Cup
5. Mouthpiece
6. Nebulizer Kit (assembly of items 2 to 4 )
7. Main Unit
8. Air Hose
9. USB Type C Cable
10. Air Opening
11. Air Inlet
12. Power Button
13. 4G Connection Indicator
14. Power Button Indicator
15. Battery Compartment
16. USB Type C Port (for recharge)

NOTE:

• Use only the parts listed above that are distributed by ForaCare; use of other parts may constitute a hazard.
• The item 1 to 5 , 8 are regarded as consumable accessories. 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.

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 temperatures 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 nebulization 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 operation, 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.
   • Align and insert the assembled cap on the medicine cup.

• Turn clockwise, and the junction of the nebulizer kit will become one full circle.

4. Attach the mouthpiece (or mask) to the cap ( 1 ). You can directly connect the nebulizer kit to the main unit ( 2 ), or connect the air hose to the nebulizer kit ( 3 ) and the main unit ( 4 ) 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”.

CLEANING AND MAINTENANCE

Cleaning Steps
Please clean your device after each use according to the instructions below.
Before Cleaning
Make sure that the nebulizer is turned off before disassembly.

1. Pull out the mouthpiece or mask ( 1 ), and detach the nebulizer kit from the main unit ( 2 ).

2. Turn couterclockwise, and depart the cap with spray nozzle from the medicine cup.

3. Take the spray nozzle and cap apart.

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.

Notice what can be immersed (left) and cannot be immersed (right) in the water.

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 environmental 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.

LED INDICATORS

4G        Power

| Ready for use / Standby mode| The nebulizer is on standby, ready to start at any time.
| First time activate the nebulizer.| Pull out the mylar. Both 4G and Power indicators will light up simultaneously and change color in sequence as shown.

| Nebulization mode.| Press the power button to activate the nebulizer.

| Low battery| The nebulizer is functional, but it is time to recharge.

| The battery is too low. Plug in the power plug to recharge.
| Recharge the battery| Battery recharge is in progress.

| The battery is fully recharged.
| Initiate the 4G connection| Press and hold the power button for 5 seconds in standby mode.
| Press the power button during nebulization.
| Data upload failed| Flashing yellow and turning off automatically in 10 seconds.
| 4G connection succeeded| The indicator change from flashing blue to solid blue.
| Forced shutdown 4G connection| Press the power button during 4G connection. Flashing blue turns quicker and fades away in 8 seconds, then the nebulizer turns off.
| Data upload completed.| Solid blue and turning off automatically.

TROUBLESHOOTING

The device does not work or the device is on but nebulizes weakly.

| The battery is getting too low.| Plug in the power plug to recharge the main unit. The nebulizer will not activate while charging.
Compressor switch is off.| Turn the switch on.
Air hose is bent.| Remove any bend or kink in the air hose.
The spray nozzle does not place in its position.| Place the spray nozzle in its correct position.
No medicine is left.| Add the appropriate amount of medicine prescribed by your physician to the medicine cup.
The device is on but does not nebulize.| The nebulizer kit does not assemble well.| Re-assemble the nebulizer kit.

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. Plot of cumulative size distribution of results for particle size

NOTE:
Please contact your dealer or Customer Service Line for assistance with any other difficulties.
The device has been certified to meet the electrical and safety requirements of: IEC 60601-1, IEC 60601-1-2.

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 SootheNeb 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%.
Table 1 Results of the repeatability test for SootheNeb NBL300g Compressor Nebulizer.

C.S. – 2.92
Respirable Fraction (%, 0.5-5 μm)| Ipratropium bromide – 83.2 Ventolin – 71.5 Cromolyn sodium – 62.4| I.B. – 1.09 V. – 0.49
C.S. – 1.2

• 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 information, 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.

Cromolyn sodium – 1514.1
Respirable Mass (μg, 0.5-5 μm)| Ipratropium bromide – 106.8 Ventolin – 194.5
Cromolyn sodium – 246.5
Coarse particle Fraction (%) (> 4.7 μm)| Ipratropium bromide – 19.22 Ventolin – 31.19
Cromolyn sodium – 40.84
Fine particle Fraction (%) (< 4.7 μm)| Ipratropium bromide – 80.78 Ventolin – 68.81
Cromolyn sodium – 59.16
Ultra-fine particle Fraction (%) (< 1 μm)| 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 specifications 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.

FEDERAL COMMUNICATIONS COMMISSION (FCC) STATEMENT 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 communications. 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 equipment should be installed and operated with a minimum distance of 20 centimeters between the radiator radiation source and your body.

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.

Emission test| Compliance| Electromagnetic environment-guidance
RF emissions CISPR 11| Group 1| 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.
RF emissions CISPR 11| Class B| 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.
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations / flicker emissions IEC 61000-3-3| Compliance
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.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance
Electrostatic discharge (ESD) IEC 61000-4-2| Contact: ±8 kV Air±2 kV, ±4 kV, ±8 kV, ±15 kV| Contact: ±8 kVAir±2 kV, ±4 kV, ±8 kV, ±15 kV| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient / burst IEC 61000-4-4| ±2kV for power supply lines ±1kV for input/output lines| ±2kV for power supply lines Not applicable| Mains power quality should be that of a typical home and professional healthcare environment.
Surge IEC 61000-4-5| ±0.5kV, ±1kV line(s) to line(s) ±0.5kV, ±1kV, ±2kV line(s) to earth| ±0.5kV,±1kV line(s) to line(s)

Not applicable

| Mains power quality should be that of a typical home and professional healthcare environment.
Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 1000-4-11| Voltage dips:
0% UT; 0,5 cycle
0% UT; 1 cycle
70% UT; 25/30 cycles
Voltage interruptions: 0% UT; 250/300 cycle| Voltage  dips: 0% UT; 0,5 cycle
0% UT; 1 cycle
70% UT; 25, 30
cycles Voltage interruptions: 0% UT; 250, 300 cycle| 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.
Power frequency (50, 60 Hz) magnetic field IEC 61000-4-8| 30 A/m 50, 60 Hz| 30 A/m 50, 60 Hz| The device power frequency magnetic fields should be at levels characteristic of a typical location in a typical home and professional healthcare environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
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.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance
Conducted RF IEC 61000-4-6| 3 Vrms: 0,15 MHz – 80 MHz

6 Vrms: in ISM and amateur radio bands between 0,15 MHz and 80 MHz

| 3 Vrms: 0,15 MHz – 80 MHz

6 Vrms: in ISM and amateur radio bands between 0,15 MHz and 80 MHz

| 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.
| 80% AM at 1 kHz| 80 % AM at 1 kHz|
Radiated RF IEC 61000-4-3| 10 V/m: 80 MHz – 2,7 GHz 80% AM at 1 kHz| 10 V/m: 80 MHz – 2,7 GHz 80% AM at 1 kHz| 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:
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.
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.
Rated maximum output power of transmitter W| Separation distance according to frequency of transmitter m
150 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
0,01| 0,12| 0,12| 0,23
0,1| 0,38| 0,38| 0,73
1| 1,2| 1,2| 2,3
10| 3,8| 3,8| 7,3
100| 12| 12| 23
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.
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.

Test frequency (MHz)| Band a)

(MHz)

| Service a)| Modulation b)| Maximum power (W)| Distance (m)| IMMUNITY TEST LEVEL

(V/m)

| Compliance LEVEL (V/m)
385| 380 – 390| TETRA 400| Pulse modulation b) 18 Hz| 1,8| 0,3| 27| 27

450

|

430 – 470

| GMRS 460, FRS 460| FM c) ±5 kHz deviation 1 kHz sine| 2| 0,3| 28| 28
710| 704 – 787| LTE Band 13,  17| Pulse modulation b) 217 Hz| 0,2| 0,3| 9| 9
745
780
810| 800 – 960| GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5| Pulse modulation b) 18 Hz| 2| 0,3| 28| 28
870
930
1720| 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
1845
1970
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
5240| 5100 – 5800| WLAN 802.11 a/n| Pulse modulation b) 217 Hz| 0,2| 0,3| 9| 9
5500
5785
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.

311-7015700-003
Version 2.0
2022/12

Documents / Resources

| SootheNeb NBL300 Series Compressor Nebulizer [pdf] Instruction Manual
NBL300 Series, Compressor Nebulizer, NBL300 Series Compressor Nebulizer, Nebulizer
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| SootheNeb NBL300 Series Compressor Nebulizer [pdf] Instruction Manual
NBL300g, 7015G, NBL300 Series, NBL300 Series Compressor Nebulizer, Compressor Nebulizer, Nebulizer

References

• ForaCare – The New Leader in Medical Device Technology

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