OMRON NE-C101 Compressor Nebulizer

Intended Use

Medical Purpose

This product is intended to be used for inhaling medication for respiratory disorders.

Intended User

• Legally certified medical experts, such as doctors, nurses, and therapists.
• Caregivers or patients under the guidance of qualified medical experts for home treatment.
• Users capable of understanding the general operation of the NE-C101 and the content of this instruction manual.

Intended Patients

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

Environment

This product is intended for use in a medical facility (e.g., hospital, clinic, doctor's office) and in a general household environment.

Durable Period

Durable periods are provided below, assuming the product is used to nebulize saline 3 times a day for 10 minutes each time at room temperature (23°C). Actual durable periods may vary depending on the usage environment. Frequent use may shorten the durable period.

Precautions for Use

Warnings and cautions described in this instruction manual should be observed.

Product Overview

Thank you for purchasing the OMRON NE-C101. 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

Medication is pumped up through a medication channel and mixed with compressed air generated by a compressor pump. The compressed air mixed with medication is turned into fine particles when it contacts a baffle and is then sprayed as aerosol.

Know Your Unit

The OMRON NE-C101 Compressor Nebulizer consists of a main compressor unit and various accessories.

Compressor Unit Components

• Power Switch: Turns the device on/off (▶️/⏹️).
• Power Cord: Connects the device to the power outlet.
• Air Filter Cover: Houses the air filter.
• Ventilation Slots: Allow for air circulation to prevent overheating.
• Air Tube Connector: Connects the air tube to the compressor.

Nebulizer Kit Components

• Nebulizer Kit Holder: For resting the nebulizer kit.
• Medication Tank: Holds the prescribed medication.
• Vaporizer Head: Part of the nebulizer kit that aerosolizes medication.
• Nozzle: Directs the aerosolized medication.
• Inhalation Top: Covers the medication tank.

Included Accessories

• Nebulizer Kit (x1)
• Mouthpiece (x1)
• Nosepiece (x1)
• Adult Mask (PVC) (x1)
• Child Mask (PVC) (x1)
• Air Tube (PVC, 100cm) (x1)
• Spare Air Filters (x2)
• Instruction Manual
• Quick Start Guide

Important Safety Instructions

Read all information in this manual and any other included literature before using the device.

⚠️ Warning:

Indicates a potentially hazardous situation which, if not avoided, could result in serious injury.

Usage

• Follow your doctor's or respiratory therapist's instructions for medication type, dose, and regimen.
• Stop use and consult a doctor immediately if you experience allergic reactions or other difficulties.
• 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 parts that can be swallowed.
• Do not store the air tube with moisture or medication 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 blankets or towels during use, as it could overheat and cause burns.
• Always dispose of remaining medication after use and use fresh medication each time.
• Do not use in anesthetic or ventilator breathing circuits.
• Do not block ventilation slots. Obstructing slots can cause overheating and potential burns.
• Store parts in a clean location to avoid infection.

⚡ Risk of Electrical Shock

• Never plug or unplug the device with wet hands.
• The compressor and power cord are not waterproof. Avoid spilling water or other liquids on them. If liquid spills, immediately unplug the power cord and wipe dry.
• Do not immerse the compressor in water or other liquids.
• 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.

Cleaning and Disinfecting

Observe the following rules to prevent damage, inefficient nebulization, or infection. Refer to the "Cleaning and Disinfecting" section for detailed instructions.

• Clean and disinfect the nebulizer kit, mask, mouthpiece, or nosepiece before first use, after long periods of non-use, or if used by multiple people.
• Wash or wipe parts after each use, ensure they are thoroughly disinfected, dried, and stored cleanly.
• Do not let cleaning solution dry on the parts.

? Caution:

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury, or physical damage.

Usage

• Provide close supervision when this device is used by, on, or near children or invalids to prevent strangulation by the power cord or air tube, or injuries from mishandling.
• Ensure all parts are attached correctly.
• Ensure the air filter is correctly attached and clean. Replace if used for more than 60 days.
• Do not tilt the nebulizer kit at an angle greater than 30 degrees in any direction or shake it during use.
• Do not use or store the device with a creased air tube.
• Use only original OMRON nebulizing parts, air tube, air filter, and air filter cover.
• Do not add more than 12 ml of medication to the medication tank.
• Do not carry or leave the nebulizer kit unattended while the medication tank contains medication.
• Do not leave the device unattended with infants or persons unable to express consent.
• Do not subject the device to strong shocks, such as dropping it.
• Do not distort the vaporizer head or jab the nozzle with a sharp object.
• Do not insert fingers or objects into the compressor.
• Do not disassemble or attempt to repair the compressor or power cord.
• Do not leave the device in extreme hot or cold temperatures, or under direct sunlight.
• Do not block the air filter cover.
• Do not use the device while sleeping or if drowsy.
• Approved for human use only.
• The compressor may become hot during operation; avoid touching it unnecessarily.
• To avoid medication residue on the face, wipe the face after removing the mask.
• To avoid injury to the nose mucosa, do not insert the nosepiece too deeply into the nose.
• Do not block the slit between the cap and the inhalation air inlet.
• Ensure the vaporizer head is correctly installed before use.
• Do not use a damaged nebulizer kit, mouthpiece, or nosepiece.
• Keep mobile phones or other devices emitting electromagnetic fields at least 30cm away from the device during use to avoid performance degradation.

Risk of Electrical Shock

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

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 to prevent fire hazards.

General Safety Precautions

• Inspect the device and parts before each use. Check for damage, blockages (nozzle, air tube), and normal compressor operation.
• Normal noise and vibration from the compressor and air emission are not malfunctions.
• Operate the device only for its intended purpose.
• Do not use the device at temperatures greater than +40°C.
• Ensure the air tube is securely attached to both the compressor and nebulizer kit. Twist the air tube plug slightly when inserting to prevent disconnection.
• To completely isolate the device from the power source, unplug it.
• Using the device longer than its standard operating time may lead to deterioration and accidents.
• Keep these instructions for future reference.

How to Use

Warning: Clean and disinfect the nebulizer kit, mask, mouthpiece, or nosepiece before using them for the first time, after a long period of non-use, or if used by multiple people. Refer to the "Cleaning and Disinfecting" section for instructions.

1. Make sure the power switch is in the off (⏹️) position.
2. Plug the power plug into a power outlet. Note: Do not place the device in a location where it is difficult to disconnect the power cord.
3. Remove the inhalation top from the medication tank:
   1) Rotate the inhalation top anti-clockwise.
   2) Lift the inhalation top out of the medication tank.
4. Add the correct amount of prescribed medication to the medication tank.
5. Ensure the vaporizer head is correctly placed in the medication tank.
6. Replace the inhalation top onto the medication tank:
   1) Lower the inhalation top onto the medication tank.
   2) Rotate the inhalation top clockwise.
7. Attach the mask, mouthpiece, or nosepiece to the nebulizer kit tightly.
8. Attach the air tube. Twist the air tube plug slightly and push it firmly into the air tube connector.
9. Hold the nebulizer kit as indicated. Caution: Do not tilt the nebulizer kit at an angle greater than 30 degrees in all directions, as medication may flow into the mouth or nebulization may be ineffective.
10. Turn the power switch to the on (▶️) position. Nebulization begins, and aerosol is generated. Inhale the medication.
11. When treatment is complete, turn the power off (⏹️) and unplug the compressor from the power outlet.

Cleaning and Disinfecting

? Caution: Handling the Vaporizer Head

• Always wash the vaporizer head after each use.
• Do not use a brush or pin to clean the vaporizer head.
• When disinfecting parts by boiling, ensure they are submerged in plenty of water.
• Do not boil the vaporizer head with objects other than applicable nebulizer accessories.

Cleaning

Clean parts after each use to remove residual medication, preventing inefficient nebulization or infection.

Washable Parts

• Nebulizer Kit, Mask (PVC), Mouthpiece, Nosepiece: Wash in warm water with mild detergent (neutral detergent). Rinse thoroughly with clean hot tap water and air dry in a clean place.
• Vaporizer Head: Wash under running water.

Non-Washable Parts

• Compressor, Air Tube (PVC): Ensure the power plug is unplugged. Wipe clean with a soft cloth moistened with water or mild detergent.
• Air Filter: Do not wash or clean the air filter. If it becomes wet, replace it, as damp filters can cause blockages.

Disinfecting

Disinfect parts once a week. Replace parts if heavily stained. Refer to the table below for disinfection methods.

Key: O = Applicable, X = Not Applicable

* An example of commercially available disinfectant. Concentrations and residence times are based on tested service life conditions. Please refer to disinfectant manufacturer's instructions. ** Remove the rubber band from the mask before disinfecting. *** The band is not made with natural rubber-latex.

Method A: Using Commercial Disinfectant

Follow the instructions provided by the disinfectant manufacturer. Note: Never clean with benzene, thinner, or flammable chemicals.

Method B: Boiling

Parts may be boiled for 15 to 20 minutes. After boiling, carefully remove parts, shake off excess water, and allow to air dry in a clean environment.

Removing Condensation from the Air Tube

If moisture or liquid remains in the air tube, follow these steps:

1. Ensure the air tube is connected to the compressor's air connector.
2. Remove the air tube from the nebulizer kit.
3. Turn on the compressor and pump air through the air tube to expel moisture.

Changing the Air Filter

Replace the air filter if it has been used for more than 60 days.

1. Remove the air filter cover using a flat screwdriver.
2. Change the air filter: Remove the old filter and insert the new one.
3. Reattach the air filter cover, ensuring it is properly secured.

Notes:

• Use only OMRON air filters designed for this device. Do not operate without a filter.
• Do not wash or clean the air filter. Replace if wet, as damp filters can cause blockages.
• Air filters have no specific front or back orientation.
• Check that air filters are clean and free of dust before inserting.

Troubleshooting

If problems occur, first check that no other electrical devices are within 30cm. If the problem persists, refer to the table below.

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

Technical Data

Technical Data for the NE-C101 Compressor

Result of Cascade Impactor Measurements for Particle Size

The graph shows the cumulative percentage of particle mass of sodium fluoride under a given size. The X-axis represents Particle Size Dp (µm) from 0.1 to 100, and the Y-axis represents Cumulative Undersize % from 0 to 100. The mean Mass Median Aerodynamic Diameter (MMAD) is measured at 3.9µm.

Notes:

• Subject to technical modification without prior notice.
• This OMRON product is manufactured under the strict quality system of OMRON HEALTHCARE Co., Ltd., Japan.
• The device may not function correctly if temperature or voltage conditions differ from specifications.
• Ensure the device acclimates to room temperature before nebulizing medication. OMRON recommends waiting approximately 2 hours for the device to warm up or cool down after storage in extreme temperatures before use. Refer to Technical Data for operating and storage/transport temperatures.
• The device complies with EC directive 93/42/EEC (Medical Device Directive) and European Standard EN13544-1:2007+A1:2009.
• Performance may vary with medication viscosity or suspension. Consult the medication supplier's data sheet for details.
• IP classification indicates degrees of protection against ingress according to IEC 60529. The device is protected against solid foreign objects ≥12.5mm and against vertically falling water drops during normal operation.

Symbols Description

• ? Need for the user to consult the instructions for use
• Applied part - Type BF
• Degree of protection against electric shock (leakage current)
• Class II: Protection against electric shock
• IPXX: Ingress protection degree provided by IEC 60529
• CE Marking
• SN: Serial number
• Temperature limitation
• Humidity limitation
• Atmospheric pressure limitation
• Power OFF (⏹️)
• Power ON (▶️)
• Alternating current

Product production date is integrated into the Serial number: the first 4 digits indicate the year of production, and the next 2 digits indicate the month of production.

Correct Disposal of This Product (Waste Electrical & Electronic Equipment)

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 waste and recycle it responsibly to promote 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. This product should not be mixed with other commercial waste for disposal.

Optional Medical Accessories

(Within the scope of EC Medical Device Directive 93/42/EEC)

Other Optional/Replacement Parts

Important Information Regarding Electro Magnetic Compatibility (EMC)

The OMRON NE-C101, manufactured by OMRON HEALTHCARE Co., Ltd., conforms to the EN60601-1-2:2015 Electro Magnetic Compatibility (EMC) standard. Further documentation in accordance with this EMC standard is available at http://www.omronhealthcare-ap.com/emc-information. Refer to the EMC information for NE-C101 on the website.