OMRON Compressor Nebulizer NE-C803

Intended Use

Medical Purpose: This product is intended for inhaling medication for respiratory disorders.

Intended User: Legally certified medical experts (doctors, nurses, therapists) or caregivers/patients under the guidance of qualified medical experts for home treatment. The user must be capable of understanding the general operation and the content of this instruction manual.

Intended Patients: This product should not be used on patients who are unconscious or not breathing spontaneously.

Environment: Intended for use in medical facilities (hospitals, clinics, doctor's offices) and general household rooms.

Durable Period: Provided the product is used to nebulize 2 ml of medication twice a day for 7.5 minutes each time at room temperature (23°C), durable periods are as follows. Frequent use may shorten these periods.

• Compressor (Main unit): 5 years
• Nebulizer Kit: 1 year
• Mouthpiece: 1 year
• Nosepiece (optional): 1 year
• Air Tube (PVC, 100cm): 1 year
• Air Filter: 60 days
• Mask (PVC): 1 year

Introduction

Thank you for purchasing the OMRON Compressor Nebulizer NE-C803. This product was developed in conjunction with respiratory therapists for the successful treatment of asthma, chronic bronchitis, allergies, and other respiratory disorders. This is a medical device; operate it only as instructed by your doctor and/or respiratory therapist.

How the Nebulizer Kit Works

The nebulizer kit works by pumping medication up through a medication channel. This medication is mixed with compressed air generated by a compressor pump. The medication is turned into fine particles and sprayed when it contacts the compressed air, forming an aerosol.

Diagram Description: Illustrates medication being drawn up a channel, mixing with compressed air from a nozzle, and forming an aerosol.

Know Your Unit

Compressor (Main Unit)

Diagram Description: Shows the rear view of the compressor unit, indicating the Air Tube Connector, Nebulizer Kit Holder, Power Switch, Power Connector, and Air Filter Cover (with air filter inside).

Included Components

• Compressor (Main Unit) x 1
• Nebulizer Kit x 1 (includes Inhalation Top, Vaporizer Head, Medication Tank, Nozzle)
• Adult Mask (PVC) x 1
• Child Mask (PVC) x 1
• Mouthpiece x 1
• Air Tube (PVC, 100cm) x 1
• Spare Air Filters x 5
• AC Adapter x 1
• Storage Bag x 1
• Instruction Manual

Important Safety Instructions

Warnings

Usage

• Follow your doctor's or respiratory therapist's instructions for medication type, dose, and regimen.
• If you feel anything unusual during use, stop the device immediately and consult your doctor.
• Do not use only water in the nebulizer for inhaling purposes.
• Keep the device out of reach of unsupervised infants and children, as it may contain small pieces that can be swallowed.
• Do not store the air tube while there is moisture or medication remaining inside.
• Do not use or store the device where it may be exposed to noxious fumes or volatile substances.
• Do not use the device where it may be exposed to flammable gas.
• Do not cover the compressor with a blanket, towel, or any other cover during use.
• Always dispose of any remaining medication after use and use fresh medication each time.
• Do not use in anesthetic or ventilator breathing circuits.
• Store parts in a clean location to avoid infection.

Risk of Electrical Shock

• Never plug or unplug the AC adapter with wet hands.
• The compressor and AC adapter are not waterproof; do not spill water or other liquids on them. If liquid spills, immediately unplug the AC adapter and wipe off the liquid.
• Do not immerse the compressor in water or other liquid.
• Do not use or store the device in humid locations.
• Do not operate the device with a damaged power cord or plug.
• Keep the power cord away from heated surfaces.
• Use only the original OMRON AC adapter.

Cleaning and Disinfecting

• Observe the rules to avoid damage, inefficient nebulization, or infection. Refer to the "Cleaning and Disinfecting" section for instructions.
• Clean and disinfect the nebulizer kit, mask, mouthpiece, or optional nosepiece: for the first time after purchase, if the device has not been used for a long period, or if more than one person uses the same device.
• Wash or wipe parts after use, ensuring they are thoroughly disinfected, dried, and stored in a clean location.
• Do not leave cleaning solution in the parts.

Cautions

Usage

• Provide close supervision when this device is used by, on, or near children or invalids.
• Ensure that the parts are attached correctly.
• Ensure the air filter is correctly attached and clean. Replace it with a new one if it has been used for more than 60 days.
• Do not tilt the nebulizer kit at an angle greater than 45 degrees in any direction or shake it while in use.
• Do not use or store the device while the air tube is creased.
• Use only original OMRON nebulizing parts, air tube, air filter, and air filter cover.
• Do not add more than 10 ml of medication to the medication tank.
• Do not carry or leave the nebulizer kit while the medication tank contains medication.
• Do not leave the device unattended with infants or persons who cannot express their consent.
• Do not subject the device to any strong shocks, such as dropping it on the floor.
• Do not jab the nozzle of the medication tank with a pin or any sharp object.
• Do not insert fingers or objects inside the compressor.
• Do not disassemble or attempt to repair the compressor or AC adapter.
• Do not leave the device in extreme hot or cold temperatures, or under direct sunlight.
• Do not use the device while sleeping or if drowsy.
• Approved for human use only.
• The compressor may become hot during operation. Do not touch the compressor unnecessarily while nebulizing, except to turn off the power.
• To avoid medication residue on the face, wipe the face after removing the mask.
• To avoid injury to the nose mucosa, do not squeeze the optional nosepiece into the back of the nose.
• Do not use a damaged nebulizer kit, mouthpiece, or optional nosepiece.

Risk of Electrical Shock

• Always unplug the AC adapter from the power outlet after use and before cleaning.
• Plug the device into the appropriate voltage outlet. Do not overload power outlets or use extension cords.
• Do not misuse or pull the power cord of the AC adapter.
• Do not wind the power cord around the compressor or AC adapter.
• Changes or modifications not approved by OMRON HEALTHCARE will void the user warranty.
• Always remove the AC adapter from the device after use and before cleaning.

Cleaning and Disinfecting

• Do not use a microwave oven, dish dryer, or hair dryer to dry the device or parts.
• Do not use an autoclave, EOG gas sterilizer, or low-temperature plasma sterilizer.
• When disinfecting parts by boiling, ensure the container does not boil dry, as this may cause a fire.

General Safety Precautions

• Inspect the device and parts before each use, checking for any problems. Specifically, check that the nozzle or air tube are not damaged, the nozzle is not blocked, and the compressor operates normally.
• Some noise and vibration from the pump and compressed air emission are normal and do not indicate a malfunction.
• Operate the device only as intended. Do not use it for any other purpose.
• Do not use the device at temperatures greater than +40°C.
• Make sure the air tube is securely attached to the compressor and nebulizer kit and does not come loose.
• To completely isolate the device from the power source, unplug the plug from the power source.
• Keep these instructions for future reference.

Important Information Regarding Electromagnetic Compatibility (EMC)

With the increased number of electronic devices, medical devices may be susceptible to electromagnetic interference (EMI) from other devices, potentially leading to incorrect operation or unsafe situations. This medical device manufactured by OMRON HEALTHCARE conforms to the EN60601-1-2:2007 standard for both immunity and emissions.

Precautions: Do not use mobile phones or other devices that generate strong electrical or electromagnetic fields near the medical device. This may result in incorrect operation and create a potentially unsafe situation. A minimum distance of 7 meters is recommended. Verify correct operation if the distance is shorter.

Further documentation in accordance with EN60601-1-2:2007 is available from OMRON HEALTHCARE EUROPE or at www.omron-healthcare.com.

Correct Disposal of This Product

This marking on the product or its literature indicates it should not be disposed of with household waste at the end of its working life. To prevent harm to the environment or human health from uncontrolled waste disposal, please separate this product from other wastes and recycle it responsibly to promote the sustainable reuse of material resources. Household users should contact their retailer or local government office for recycling details. Business users should contact their supplier and check purchase contract terms.

Accessories (Sold Separately)

Technical Data

Diagram Description (Particle Size Graph): A graph illustrating particle size distribution, showing cumulative undersize percentage against particle size (Dp in µm). The Mass Median Aerodynamic Diameter (MMAD) is approximately 3µm, measured with saline at 23°C and 40% humidity, and independently verified.

[information symbol] Read the instruction manual carefully

[type BF applied part] Type BF applied part

[power-on] I = Power on

[power-off] = No operation

[CE0197] CE0197

How to Use

Step-by-step Guide

Preparation

• Step 1: Ensure the power switch is in the off [power-off] position.
• Step 2: Connect the AC adapter to the compressor and plug the power plug into a power outlet.
• Step 3: Remove the inhalation top together with the vaporizer head from the medication tank.
• Step 4: Add the correct amount of prescribed medication to the medication tank.
• Step 5: Ensure the vaporizer head is securely attached to the inhalation top. Note: The left and right parts of the vaporizer head are not the same size. Correct orientation is crucial for proper nebulization.

Operation

• Step 6: Put the inhalation top back inside the medication tank. Align the protrusion on the inhalation top with the indent on the medication tank, then rotate the inhalation top clockwise until the arrow mark aligns with the alignment mark, and it clicks into place.
• Step 7: Attach the mask, mouthpiece, or optional nosepiece to the nebulizer kit tightly. Note: Ensure these attachments are fitted so the handle is positioned away from the patient to prevent medication spray on skin or clothes.
• Step 8: Attach the air tube by pushing the air tube plugs firmly into the air tube connectors on the compressor and the nebulizer kit.
• Step 9: Hold the nebulizer kit as indicated. Caution: Do not tilt the nebulizer kit at an angle of greater than 45 degrees in any direction, as medication may flow into the mouth or nebulization may be ineffective.
• Step 10: Press the power switch to the on [power-on] position. As the compressor starts, nebulization begins and aerosol is generated. Inhale the medication.
• Step 11: When treatment is complete, turn the power off [power-off]. Unplug the AC adapter from the power outlet and disconnect it from the compressor. Note: Securely hold and press the power plug down to disconnect the AC adapter. Do not pull the power cord, as damage may be caused.

Removing Condensation from the Air Tube

• Ensure the air tube is connected to the air connector on the compressor.
• Remove the air tube from the nebulizer kit.
• Turn on the compressor and pump air through the air tube to expel any moisture.

Changing the Air Filter

Replace the air filter if it has been used for more than 60 days or if it becomes wet. Damp air filters can cause blockages.

• Step 1: Pull the air filter cover off the compressor.
• Step 2: Change the air filter.
• Step 3: Put the air filter cover back in place, ensuring it is attached properly.

Notes: Use only OMRON air filters designed for this device. Do not operate without an air filter. Do not wash or clean the air filter. There is no specific front or back orientation for the air filters. Check that air filters are clean and free of dust before inserting them.

Cleaning and Disinfecting

Cleaning

Clean the parts after each use to remove residual medication, which prevents inefficient nebulization or infection.

Washable Parts

Nebulizer Kit (Inhalation top, Medication tank), Mask (PVC), Mouthpiece, Nosepiece (optional). Wash them in warm water and mild detergent (neutral detergent). Rinse them thoroughly with clean hot tap water and allow to air dry in a clean place.

Vaporizer Head

Wash it with running water. Do not use a brush or pin to clean the vaporizer head. Do not boil the vaporizer head together with objects other than applicable nebulizer accessories.

Non-washable Parts

Compressor, Air Tube. Ensure the power plug is unplugged. Wipe clean with a soft cloth moistened with water or mild detergent. Allow to air dry.

Air Filter

Do not wash or clean the air filter. If the air filter becomes wet, replace it.

Disinfecting

Disinfect the parts once a week. If the parts are heavily stained, replace them with new ones. Refer to the table below for disinfection methods.

*An example of commercially available disinfectant. Follow the instructions provided by the disinfectant manufacturer. The concentration and residence time specified are based on tested conditions. Please note that testing was not performed to ensure disinfectant effectiveness, and conditions may vary by manufacturer. Always read disinfectant instructions carefully. Service life of parts may be shorter depending on conditions and frequency of use. Never clean with benzene, thinner, or flammable chemicals. After boiling, carefully remove parts, shake off excess water, and allow to air dry in a clean environment.

Troubleshooting

Note: If the suggested remedy does not solve the problem, do not attempt to repair the device, as it is not user-serviceable. Please contact an authorized OMRON representative for assistance.