Rossmax NC200 - Mesh Nebulizer Manual

Introduction

With proper care and use, your nebulizer will provide you with many years of reliable treatments. Treatments are delivered quickly, safely and conveniently making this unit ideal for all ages. We encourage you to thoroughly read this guidebook to learn about the features of your nebulizer. Your mesh 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 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 fulfils the provision 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.

Cautions

Please use general safety precautions when operating your nebulizer. This unit should be used only for its intended purpose as described in this guidebook and with medications only under the supervision and instruction of your physician. Do not use the device in anesthetic or ventilator breathing circuits.

Product cautions

READ THE FOLLOWING BEFORE USING

• To avoid electrical shock: keep unit away from water.
• 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.
• If the medication cup is empty, do not attempt to operate the unit.
• If any abnormality occurs, discontinue using until the unit has been examined and re-paired.
• 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 plug or unplug the AC adapter into the electrical outlet with wet hands.
• Unplug the AC adapter from the electrical outlet after using the device.
• Do not disassemble or attempt to repair the unit.
• Do not use the device in anesthetic or ventilator breathing circuits.
• Use only original Rossmax accessories/parts as included in the product.

Operating cautions

• Microbial contamination: personal use of all parts is recommended in order to prevent any risks of contagious infection.
• Before each use, inspect the device and all parts. If damaged or deteriorated, replace it at once.
• 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 8 ml/c.c. 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.
• Pentamidine is not an approved medication for use with this device.
• Do not service or maintain device while in use.
• Do not use AC Adapter for any other purpose than those specified, as they can cause risk of strangulation.
• The correct functioning of the device may be affected by electromagnetic interference caused by malfunctioning television sets, radios, etc. If this occurs, move the source of interference away from the device or plug it into a different power socket.

Storage cautions

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

Cleaning cautions

• Check 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 use gravity autoclave, EOG gas disinfection or low temperature plasma sterilizer to disinfect the unit and parts.
• Carry out the cleaning procedures after every application for maximum hygiene to avoid cross infection and extend the life of the unit.
• Do not use any hard object to clean and/or detach the unit in order to avoid any damage.
• Do not use a microwave oven, dish dryer or hair dryer to dry the device or the parts.

Medical Disclaimer

This manual and product are not meant to be a substitute for advice provided by your doctor or other medical professionals.

Do not 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 are as follows, provided the product is used to nebulize 2ml of medication 2 times a day for 7 minutes each time at room temperature (25°C).

Durable period may vary depending on usage environment.

• Main unit 3 years
• Mouthpiece 1 year
• Medication Cup 1 year
• Child mask 1 year

Mesh Technology

Rossmax Mesh nebulizer is built with state of the art technology. The Mesh nebulizer uses electricity to vibrate a piezo that moves liquid formulations through a mini aperture plate to generate very fine aerosol medication for respiratory treatment. The battery operation, the portable design and the very quiet performance make Rossmax Mesh nebulizers very convenient and effective.

Product identification

1. Lid
2. Air port
3. Operation LED
4. On/Off button
5. Medication cup
6. Release button
7. Main unit
8. Mesh
9. Micro USB port
10. Battery cover
11. Mouthpiece
12. 2 "AA" size 1.5V batteries (Alkaline)
13. Child mask
14. USB cable

Installing Batteries

1. Follow the direction of the arrow to open the battery cover and install or replace 2 "AA" sized batteries in the battery compartment according to the indications inside the compartment, then fold the battery cover to cover it.
2. Replace the batteries in pairs. Remove batteries when unit is not in use for extended periods of time.

You need to replace the batteries when

1. Low battery indicator (green) flashes on LED.
2. The ON/OFF button is pressed and nothing appears on LED.

1. Batteries are hazardous waste. Do not dispose them together with the household garbage.
2. There are no user serviceable parts inside. Batteries or damage from old batteries are not covered by warranty.
3. Use only alkaline batteries or nickel-metal-hydride rechargeable batteries. Always replace with new batteries together. Use batteries of the same brand and same type.

Using the USB cable with authorized AC Adapter (Optional)

1. Connect the USB cable with AC adapter, insert the USB cable into Micro USB port in the back of the unit.
2. Plug the AC adapter into the socket.

1. Please unload the batteries when operating with the AC mode for a longer period of time.
2. AC adapter is not supplied by Rossmax, use only the authorized USB Adapter (5V) that complies with the relevant safety standards for medical devices including EN 60601-1: 2006+A1:2013 and related collateral standards as EN 60601-1-2: 2015.
3. AC adapter cannot be used for charging batteries.
4. USB cable can only be connected with Rossmax nebulizer and AC adapter. It cannot be used for any other purpose.

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.

NOTE: Always unplug the nebulizer and turn off the power-switch before cleaning, assembling and before or after each use.

1. Remove the medication cup from the main unit by pressing release buttons on both sides.
   NOTE: Do not touch the Mesh.
2. Open the lid of the medication cup by lifting the clip.
3. Add the prescribed amount of medication to the medication cup.
   NOTE: If high-viscosity medicine is used, nebulization rate may be reduced.
4. Put the lid of the medication cup back and press the clip in place.
5. Place the medication cup onto the main unit until you hear it click into place on the left and right sides.

NOTE:

• Make sure that the connectors between main unit and medication cup are clean and the two parts are properly attached.
• Before placing the medication cup with main unit, ensure that the batteries or the Adapt-er are inserted.

Operating your nebulizer

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

1. Attach the mask or mouthpiece to the top of the nebulizer.
2. The recommended filling amount is between 2~6 ml in medication cup.
3. Power on the On/Off button to start the nebulization. When device is ready, the LED stays on green.
4. Once the medicine has been fully sprayed out, the device switches off automatically.

NOTE: For technical reasons, it will take longer to power off the device, and/or a small amount may still remain in the medication cup.

1. Do not touch the air port on the top of medication cup when nebulization.
2. To ensure that the device functions completely, make sure that the medicines come into contact with the mesh while in use.
3. If the therapy requires various different medicines be inhaled one after another, ensure the nebulizer is cleaned after every nebulization.
4. Essential oils, cough medicines, solutions designed for gargling, and drops for application to the skin or for use in steam baths are wholly unsuitable for inhalation using a nebulizer. These substances are often highly viscous and can impair the function of the device and hence affect the effectiveness of its application.
5. Do not attempt to operate the nebulizer if the medication cup is empty.
6. To prevent damage to the mesh, the nebulizer will power off automatically after operating for 15 minutes.

Operating your nebulizer

After every use:

1. Power off the device, unplug the device from the power source.
2. Carefully detach the accessories and medication cup from the nebulizer and pour out any remaining liquid.
3. Follow the cleaning procedures provided in this guidebook.

Cleaning procedures

1. After each treatment, before storing, please discard the residue medicine, then fill with 1~2ml of cold boiled water and nebulize it till the cup is entire empty for completely cleaning the Mesh.
2. Make sure to "Power OFF" the nebulizer, then disconnect the power source.
3. Detach the mouthpiece or mask from the nebulizer and pour out any remaining liquid by placing the medication cup horizontally and tilt it a bit to pour off any residue liquid.
4. Remove the medication cup from the main unit by pressing the release buttons on both sides.
5. Except for the main unit, rinse all the disassembled components and accessories with the clean tap water lower than 40ºC.
6. Dry with clean towels or completely air dry.
   NOTE: Do not touch the mesh with any towel or other material.
7. Ensure the electrodes on medication cup fully dry and the medication cup is completely cleaned as based on the above cleaning process.
8. Make sure well following the above cleaning process; or the lifetime of the medication cup and main unit will be shortened.

NOTE:

1. For the first time cleaning or after the unit has been stored for a long period of time, thoroughly clean all components before using.
2. The mesh must not be rinsed under running water.
3. Do not clean the nebulizer or accessories in a dish-washer.
4. The nebulizer must be operated only when it is completely dry.
5. Ensure that no water penetrates inside the main unit. Any liquid that penetrates into the main unit can damage the electrical parts or other nebulizer components and impair the function of the device.

Cleaning the main unit

Wipe the main unit daily using a damp lint free cloth and use a dry lint free cloth to wipe the main unit dry.

NOTE: Never clean with benzene or thinner. Any other form of cleaning or cleaning agents may damage the finish of the unit.

Troubleshooting

Product specifications

Protection against electric shock:

• Class II equipment.

Type BF applied parts:

• Mouthpiece and mask.

Protection against harmful ingress of water and particulate matter:

• IP22

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).