Rossmax NE100 Compressor Nebulizer

Introduction

Thank you for purchasing the Rossmax NE100 Compressor Nebulizer. With proper care and use, your nebulizer will provide you with many years of reliable treatments. This unit operates on standard AC power. Treatments are delivered quickly, safely, and conveniently, making this unit ideal for all ages in healthcare settings like hospitals and home care. We encourage you to thoroughly read this guidebook to learn about the features of your nebulizer. Your compressor nebulizer should be used under the supervision of a licensed physician and/or a respiratory therapist. Together with your physician and/or respiratory therapist, you can feel comfortable and confident knowing that you are obtaining the most effective inhalation treatments for your respiratory condition.

NOTE: Your nebulizer is intended for use in the treatment of asthma, COPD, and other respiratory ailments in which an aerosolized medication is required during therapy. Please consult with your physician and/or pharmacist to determine if your prescription medication is approved for use with this nebulizer. For type, dose, and regime of medication, follow the instructions of your doctor or respiratory therapist.

This device fulfills the provisions of the EC directive 93/42/EEC (Medical Device Directive) and the European Standard EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components.

Please read this manual carefully before use and be sure to keep this manual.

Product Cautions

READ THE FOLLOWING BEFORE USING:

• To avoid electrical shock: keep unit away from water.
• Do not handle the unit or power cord with wet hands.
• Do not immerse the unit in liquid.
• Do not use while bathing.
• Do not reach for a unit that has fallen into water; immediately unplug the unit.
• Do not use the unit if it has any damaged parts (including plug), if it has been submersed in water or dropped. Promptly send the unit for examination and repair.
• The unit should not be used where flammable gas, oxygen, or aerosol spray products are being used.
• Keep the air vents open. Do not place the unit on a soft surface where the openings can be blocked.
• If the medication cup is empty, do not attempt to operate the unit.
• If any abnormality occurs, discontinue use until the unit has been examined and repaired.
• The unit should not be left unattended while plugged in.
• Do not tilt or shake the unit when in operation.
• Disconnect the unit from the electrical outlet before cleaning, filling, and after each use.
• Do not use attachments unless recommended by the manufacturer.
• Do not disassemble or attempt to repair the unit.
• Do not use the device in anesthetic or ventilator breathing circuits.

Operating Cautions

• Close adult supervision is highly recommended when the unit is used by children or invalids.
• Keep your eyes away from the output of medication mist.
• The maximum capacity of the medication cup is 5 ml and should not be overfilled.
• Do not use this unit while operating a vehicle.
• If any discomfort or abnormality occurs, stop using the unit immediately.
• Do not use the device if the air tube is bent.
• Pentamidine is not an approved medication for use with this device.
• Do not use the tubing and/or AC adaptor/power cord for any other purpose than those specified, as they can cause risk of strangulation.
• Do not service or maintain the device while in use.

Storage Cautions

• Do not store the unit in direct sunlight, high temperature, or humidity.
• Keep the unit out of reach of small children.
• Always keep the unit unplugged while not in use.

Cleaning Cautions

• Check air filter, nebulizer, mouthpiece, and any other optional component before each use. Dirty or worn parts should be replaced.
• Do not immerse the unit in water. It may damage the unit.
• Disconnect the unit from the electrical outlet before cleaning.
• Clean all necessary parts after each use as instructed in this guidebook.
• Always dispose of any remaining medication in the medication cup after each use. Use fresh medication each time you use the device.
• Do not store the air tube with moisture or medication remaining in the air tube. This could result in infection as a result of bacteria.

Medical Disclaimer

This manual and product are not meant to be a substitute for advice provided by your doctor or other medical professionals. Don't use the information contained herein or this product for diagnosing or treating a health problem or prescribing any medication. If you have or suspect that you have a medical problem, promptly consult your doctor.

Durable Periods

Durable periods are as follows, provided the product is used to nebulize 2ml of medication 2 times a day for 8 minutes each time at room temperature (25°C). Durable period may vary depending on usage environment.

• Main unit: 5 years
• Nebulizer Kit: 1 year
• Air Tube, Mouthpiece: 1 year
• Air Filter: 60 days
• Adult and child masks: 1 year

Product Specifications

* Subject to technical modification without prior notice.

* Performance may vary with drugs such as suspensions or high viscosity. See drug supplier's data sheet for further details.

A. Product Identification

1. Nebulizer Kit
2. Nozzle
3. Angled Mouthpiece
4. Air Filter
5. Child Mask
6. Adult Mask
7. Air Tube
8. Air Output
9. Air Filter Slot
10. Air Intake
11. Power Cord
12. Power Switch

B. Assembling Your Nebulizer Kit

Follow the cleaning instructions in this guidebook under "Cleaning technique" prior to using your nebulizer for the first time or after it has been stored for an extended period of time.

REMEMBER: Always unplug the compressor and make sure the power switch is turned to the "OFF" position before cleaning, assembling, and before or after each use.

1. Place the compressor on a flat, stable surface within reach.
2. Gently twist and pull straight up on the lid of the nebulizer kit to separate into two parts (medication cup and cover).
3. The stem inside the medication cup inserts into the tube of the nozzle.
4. Add the prescribed amount of medication to the medication cup.
5. Reassemble the nebulizer kit by carefully twisting the medication cup and cover together. Make sure that the two parts fit securely.

WARNING: The symbol on this product means that it's an electronic product and following the European directive 2012/19/EU, the electronic products have to be disposed of at your local recycling centre for safe treatment.

C. Operating Your Nebulizer

The nebulizer kit is operable at up to a 45° angle. If the angle is greater than 45°, no aerosol will be generated.

1. Attach one end of the air tube connector to the air output.
2. Carefully attach the opposite end of the air tubing connector to the stem at the base of the nebulizer kit.
3. Attach the angled mouthpiece or mask to the top of the nebulizer kit.
4. The capacity of the medication cup is 2~5 ml.

NOTE: A 30-minute interval is recommended after each use. The compressor will automatically shut off if it becomes overheated. If/when this happens, immediately:

1. Press the power switch to the "OFF" position.
2. Unplug the power cord from the outlet.
3. Allow the motor to cool for 30 minutes.

Before restarting the unit, make sure that the air vents are not obstructed.

Operating Your Nebulizer After Every Use:

1. Unplug the unit from the power source.
2. Allow the unit to completely cool.
3. Carefully detach the air tubing from the nebulizer and pour out any remaining medication.
4. Follow the cleaning procedures provided in this guidebook.

D. Cleaning Procedures

Rinsing Technique (performed after each treatment or before first use):

1. Make sure that the power switch has been turned to the "OFF" position and the unit has been disconnected from the power source.
2. Disconnect the air tube from the nebulizer device.
3. Gently twist and pull up the cover of the nebulizer kit to open and separate.
4. Rinse the nebulizer kit and components with hot tap water.
5. Dry with clean towels or completely air dry.
6. Reassemble the nebulizer kit.

NOTE: For the first time cleaning or after the unit has been stored for an extended period of time, thoroughly clean all components, except the air tube. The nebulizer kit is dishwasher safe.

Cleaning the Compressor:

Wipe the compressor daily using a soft cloth.

NOTE: Any other form of cleaning or cleaning agents may damage the finish of the unit.

E. Changing the Air Filter

It is important to change the air filter approximately when the air filter turns gray. It is recommended to change the air filter every 2 months.

1. Remove the air filter cover by gently pulling forward.
2. Discard the gray filter.
3. Replace with a new, clean air filter.
4. Securely re-attach the air filter cover to the unit.

NOTE: Air filters cannot be cleaned or washed. Only NE100 air filters can be used. Do not substitute alternate material such as cotton. Do not operate without an air filter.

Troubleshooting

If any abnormality occurs during use, please check and correct the following:

1. Unit does not operate when power switch is pressed: Check the AC connection to the outlet.
2. No misting or low rate of misting:
   • Check that there is medication in the nebulizer cup.
   • Check the main unit for any physical damage.
   • Check the position of the nozzle inside the nebulizer.
   • Make sure that the air tube and other components are properly attached.
   • Check the air filter and replace if necessary.

Safety Information

• Protection against electric shock: Class II equipment.
• Type BF applied parts: Mouthpiece and mask.
• Protection against harmful ingress of water and particulate matter: IP21.
• Degree of safety in the presence of flammable anesthetics or oxygen: No AP/APG (not suitable for use in the presence of flammable anesthetics or oxygen).

Electromagnetic Compatibility Information

1. This device needs to be installed and put into service in accordance with the information provided in the user manual.

2. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the NE100, including cables specified by the manufacturer. Otherwise, degradation of the performance of this device could result.

If higher IMMUNITY TEST LEVELS than those specified in Table 9 are used, the minimum separation distance may be lowered. Lower minimum separation distances shall be calculated using the equation specified in 8.10.

Manufacturer's declaration-electromagnetic immunity

The NE100 is intended for use in the electromagnetic environment specified below. The customer or the user of the NE100 should assure that it is used in such an environment.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

More information on EMC compliance of the device can be obtained from the Rossmax website: www.rossmax.com.

Accessories (Optional)

* Please follow the disinfecting methods to boil and wash the accessories.

Warranty Card

This instrument is covered by a 3-year guarantee from the purchase date. The guarantee is valid only on presentation of the guarantee card completed by the dealer confirming the purchase date or the receipt. Nebulizer Components are not included. Opening or altering the instrument invalidates the guarantee. The guarantee does not cover damage, accidents, or noncompliance with the instruction manual. Please contact your local seller/dealer or www.rossmax.com.

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Product Information

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