311-7001200-035

Version 4.0 2017/11

1. Mouthpiece and mask are intended for use by one user. DO NOT SHARE.2. Accessories are consumable parts, e.g. mesh cap. Clean the accessories after each use and replace with new accessories when they become dirty and obstructed.3. Mask and AC Adapter may be provided separately, please contact your local dealer for purchase, or contact our customer service line for more information.

NOTE

Do not wet the connector and connector socket (refer to Description of Part 3 & Part 4).Use the equipment only for its intended use as described in the operating instructions. Do not use

attachments not recommended by the manufacturer. Use the AC Adapter (Input: AC, 100-240V & Output: DC, 6V) provided by ForaCare, Inc.Do not use the device under conditions of inter-hospital transport. This device is not intended for

transport use.

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.

Prior to using 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 be a choking hazard if inhaled or swallowed.

To prevent any dangers or hazards, please do not try to modify the device in any way.

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.

Avoid dropping, smashing, hitting, or tapping the nebulizer unit or the mesh cap.

Please clean the nebulizer accessories after every use, or after storing for a period of time.

Do not expose the nebulizer to direct sunlight, high temperatures or humidity.

Performance information provided by the manufacturer in accordance with the standard EN

13544-1:2007 may not apply to drugs supplied in suspension or high viscosity form. Please consult

the drug supplier for such information.

IMPORTANT INFORMATION ABOUT INHALATION THERAPY

SAFETY PRECAUTIONS

The device is ideally suitable for inhalation at home or when traveling. Carry out inhalation in a quiet and relaxed state, and inhale slowly and deeply, so that the medication can penetrate to the fine, deep bronchial tubes. Exhale normally.

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 indicator light will turn green when the device is working normally.

The device automatically turns off when idle for 15 minutes.

2. Attach the mesh cap and screw it tightly in clockwise direction.

1. Press and release the ON/OFF button. The unit turns on and delivers prescribed medication continuously for up to 15 minutes.

4. Attach the mask or the mouthpiece to the adapter.

5. Connect the AC adapter or go to step 6 if the batteries are already installed.6. Press the ON/OFF button to begin treatment according to the physician’s instructions. See "Delivery Mode" for details on automatic and manual deliveries.7. To end the treatment, press the ON/OFF button to turn off.

OPERATING INSTRUCTIONSImportant information before use. These operating instructions provide important information to help you use the device properly.

Unit Assembly and Usage

DELIVERY MODE

CLEANING AND MAINTENANCE

This system provides you with two delivery modes: automatic or manual.

Cleaning of Nebulizer Accessories

Please clean your device accessories after each use.Prior to cleaning, make sure you have some distilled water on hand and ensure that the device has completed the last medicine delivery cycle and is completely turned off.

* AUTOMATIC AEROSOL DELIVERY

FEATURES

CONTENTS INCLUDED & DESCRIPTIONS

INTENDED USE

Delivers aerosol automatically or manuallyBattery powered or AC adapter connection (optional) Small nebulization particle size – approx. 5 micronsConvenient design – compact and lightweight. Ideal for traveling.Short treatment time – with high nebulization rate

Dear SootheNeb NBL100 Owner:Thank you for purchasing the SootheNeb NBL100, before using this product, please read the following contents thoroughly and carefully.

If you have other questions regarding this product, please contact the place of purchase or call our customer service line at 888.307.8188.

SootheNeb NBL100 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize physician-prescribed solution for inhalation by the patient, except for Pentamidine. The SootheNeb NBL100 is intended for use by patients in a home care environment.

Cautions: Federal law restricts this device to only be sold by or on the order of a physician.

Before you start to use your SootheNeb NBL100, please check that the following contents are included in the package and not broken. The use of other contents not listed may constitute a hazard.

Mesh Nebulizer Operating Instructions

NBL100

1. Unit Lid

Mesh Cap

Connector

Connector Socket

Indicator

2.

3.

5.

4.

6.

Mask or Mouthpiece Adapter

7.

8.

ON/OFF Button10.

Medication Cup9.

Battery Cover11.

13. 2 “AA” Alkaline Batteries

14.

15.

Mouthpiece

AC Adapter

MaskOPTIONAL PARTS**

INCLUDED PARTS

12.

2.

1.

4.

3.

5.

6.

7.

8.

10.

9.

11.

15.14.

13.

12.

Nebulizer Unit

AC Adapter Jack

1. Pour the prescribed medication slowly into the medication cup. The maximum capacity is 5 ml.

3. Attach the mask or mouthpiece adapter.

2. Press the ON/OFF

button to switch off

the device and

terminate the

treatment.

1. Press and hold the

ON/OFF button for 2

seconds or longer to

begin medication

delivery.

1. Remove the Mask or Mouthpiece and remove the Mask/Mouthpiece adapter from the Main Unit. Rinse thoroughly and set aside to dry. Then remove the Mesh Cap counterclockwise from the Medication Cup and keep the medication cup attached.

To deliver medication manually, press the ON/OFF button intermittently to accompany your breathingrate.

* MANUAL AEROSOL DELIVERY

Repeat step 1 and 2 for additional medication deliveries.

2. Release the ON/OFF

button to stop

medication delivery.

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 USAProducts 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 Storage1. 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 ReplacementReplace the batteries when the light indicator is red.

DisposalDispose 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 SolutionThe indicator turns red.

The device does not work when the ON/OFF button is pressed.

The indicator is green butthe device does not producemists or produces smallamounts 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 arenot 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 – 438.94µgVentolin – 889.56µgCromolyn 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 – 86.21µgVentolin – 224.3µgCromolyn 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 sodiumVentolin

MMAD (micron)

GSD(geometric standard deviation)

Respirable fraction (% mass 0.5- 5µm)

Features

SPECIFICATIONSModel no.: SootheNeb NBL100Dimension & Weight: 53(D)mm x 103(H)mm, 83gPower Source: 2 x AA alkaline batteriesInput: 100~240V, ACOutput: 6V, 1A, DCOperating conditions: 41°F to 104°F (5°C to 40°C), 15% to 93% relative humidityStorage conditions: -13°F to 158°F (-25°C to 70°C), 10% to 95% relative humidity

Power consumption: 1.2WNebulization rate: 0.25 ml/minMedication capacity: 5 mlMMAD: 5 microns

Features Mean C.V. (%)≦5%.MMAD (µm)

Geometric Std. Dev. (GSD)

Respirable Fraction (%, 0.5-5 µm)

Ipratropium bromide – 1.89µmVentolin – 2.87µmCromolyn sodium – 2.7µm

I.B. – 1.61V. – 1.25

C.S. – 1.49

I.B. – 2.69V. – 2.05

C.S. – 1.52

I.B. – 0.43V. – 0.72

C.S. – 0.41

Ipratropium bromide – 85.6%Ventolin – 74.6%Cromolyn sodium – 74.7%

Ipratropium bromide – 2.05Ventolin– 2.4Cromolyn 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

WARNINGDo not wet the medication cup connector and the connector socket.