OMRON C28P Compressor Inhaler (NE-C105-E) - User Manual

Intended Use

Medical Purpose: This product is intended for inhaling medications for respiratory conditions. The compressor is designed for repeated use by multiple patients, while the inhalation set and its accessories are intended for single-patient repeated use.

Intended User: Healthcare professionals (doctors, nurses, therapists with certification), healthcare personnel, or patients under the supervision of qualified healthcare professionals. The user must be able to understand the general principles of the C28P nebulizer and the contents of this manual.

Target Patients: Individuals of any age who have respiratory diseases and require inhalation therapy.

Environment: This product is intended for use in healthcare facilities such as hospitals, clinics, and doctor's offices, as well as for general home use.

Lifespan: When used for inhalation 3 times daily for 10 minutes each at room temperature (23°C), the lifespan is as follows. Lifespan may vary depending on the environment of use.

• Compressor (main unit): 7.5 years
• Power supply cord: 7.5 years
• Nebulizer set/Mouthpiece/Mask for children/Mask for adults/Air tubing/Adapter: 1 year
• Air filter: 60 days

Frequent use may shorten the lifespan.

Principle of Operation

The medication, fed through a channel, mixes with compressed air generated by the compressor pump. The compressed air mixed with medication turns into fine particles that are sprayed when they come into contact with the nebulizer on the vaporizing head.

[Diagram description: A diagram shows compressed air entering from the bottom, mixing with liquid medication in a chamber, and being sprayed as aerosol upwards through a nozzle.]

Nebulizer Set with Advanced Valve Technology (AVT)

The C28P nebulizer is equipped with a breath-enhanced valve system that allows patients to inhale the maximum amount of medication. It optimizes medication flow during inhalation and reduces medication loss during exhalation. Synchronizing aerosol flow with breathing optimizes the therapeutic effect of inhaled medications.

Note: Only the mouthpiece allows for synchronized AVT function.

Inhalation Phase: During inhalation, the inhalation valve (A) opens, and air enters the nebulizer. Air mixes with the generated aerosol (B) and is inhaled by the patient through the mouthpiece (C). The exhalation valve (D) remains closed during this phase, preventing aerosol loss.

[Diagram description: Diagram showing inhalation phase. Inhalation valve (A) open, exhalation valve (D) closed. Air flows in, mixes with aerosol (B), and is inhaled through mouthpiece (C).]

Exhalation Phase: During exhalation through the mouthpiece, the inhalation valve (A) of the nebulizer closes, preventing aerosol from escaping the nebulizer. The generated aerosol remains in the nebulizer, becoming available for the next inhalation phase. Exhaled air exits the mouthpiece through the exhalation valve (D).

[Diagram description: Diagram showing exhalation phase. Inhalation valve (A) closed, exhalation valve (D) open. Exhaled air exits through valve (D).]

Getting to Know the Device

Compressor (Main Unit)

• Air tubing connection port
• Nebulizer set holder
• Air filter cover with air filter
• Power switch + indicator light
• Power supply cord
• Plug

Rear View

• Ventilation openings

Nebulizer Set

• Top cover
• Vaporizing head
• Medication cup
• Air tubing connection port

Accessories

• Mouthpiece set (includes mouthpiece, cap, exhalation valve, inhalation valve)
• Adult mask (PP+TPE) with elastic strap
• Child mask support adapter (PP)
• Child mask (PP+TPE) with elastic strap

Included Items

• User Manual
• Carrying Bag
• 5 Spare Air Filters

Air Tubing (PVC, 150 cm)

Important Safety Instructions

[Icon: 'i'] Read the manual carefully before use.

WARNING:

1. Use this device only as an inhaler for therapeutic purposes. Any other use is improper and may be dangerous. The manufacturer is not responsible for misuse.
2. Do not use the device with anesthetics or ventilators.
3. Always unplug the power cord before use and cleaning.
4. Do not cover the ventilator openings during use. The compressor may become hot, posing a burn risk upon contact.
5. The compressor and power cord plug are not waterproof. Do not spill water or other liquids on these parts. If a spill occurs, immediately unplug the power cord and wipe up the liquid.
6. Do not attempt to repair the device. Refer to the "Troubleshooting" section.
7. Store the device out of reach of unsupervised children. The device contains small parts that could be swallowed.
8. Use this device with increased caution for children and individuals with disabilities.
9. Follow your doctor's or respiratory specialist's instructions regarding medication type, dosage, and regimen.
10. This product must not be used by unconscious patients or patients without spontaneous breathing.
11. After treatment, remember to disconnect the air tubing from the nebulizer set and the compressor.
12. Due to their length, the electrical cord and air tubing may pose a strangulation hazard.
13. Ensure the compressor is used in a location where the power cord plug is easily accessible during treatment.
14. If any allergic reactions or other discomforts occur during use, stop using the device immediately and consult your doctor.
15. When using this device, ensure no mobile phones or other electrical devices generating electromagnetic fields are within 30 cm of the unit. This could lead to performance degradation.
16. Do not use oils, decoctions, or herbal tinctures for inhalation in the compressor inhaler.
17. The nebulizer set and its accessories are intended for single-patient use. Do not use with multiple patients. Use separate accessories for each patient.
18. Clean parts after each use and disinfect them once a week with regular use.

Procedure

1. Ensure the power switch is in the OFF position (power indicator light is off) and the power cord plug is disconnected from the electrical outlet.
2. Remove the top cover of the nebulizer from the medication cup.
   1. Twist the nebulizer top cover counter-clockwise.
   2. Remove the nebulizer top cover from the medication cup.
3. Add the correct amount of prescribed medication to the medication cup. Be sure to follow instructions regarding the minimum and maximum fill volume (refer to Technical Specifications). If the nebulizer set contains too little or too much medication, nebulization, and therefore treatment, will be significantly affected.
4. Verify that the nebulizer top cover is securely attached to the nebulizer top cover.
5. Reattach the nebulizer top cover to the medication cup.
   1. Place the nebulizer top cover onto the medication cup.
   2. Twist the nebulizer top cover clockwise.

Using the Mouthpiece

1. Check the correct seating of the valves. Refer to the illustration.
2. Attach the mouthpiece to the nebulizer set and secure the cap onto the nebulizer top cover.
3. Hold the mouthpiece in your mouth during both inhalation and exhalation to best utilize the valve system.

Note: Children or patients with special needs should use a mask instead of a mouthpiece. If using a mask, ensure the cap is removed from the nebulizer top cover.

[Icon: Warning symbol] Attention: To remove the mouthpiece from the nebulizer set, it is important to first detach the cap from the nebulizer top cover and then pull it off. Do not reverse this order! Follow this order!

Using the Adult Mask

1. Attach the adult mask to the nebulizer set.

Using the Child Mask and Adapter

1. Attach the child mask to the support adapter and then attach them to the nebulizer set.

7. Connect the air tubing. Gently twist the end of the air tubing to securely attach it to the air tubing connection port.
8. Hold the nebulizer assembly as shown in the illustration on the right. Follow your doctor's or respiratory specialist's instructions.

[Icon: Warning symbol] Attention: Do not tilt the inhalation set in any direction at an angle greater than 30 degrees. Medication could spill into the mouth, or it may lead to ineffective inhalation.

9. Insert the power cord into the compressor socket and plug the power supply cord into the electrical outlet.

Note: Do not place the device in locations where the power cord is difficult to unplug.

10. Turn on the compressor by pressing the power switch. The blue power indicator light will illuminate. When the compressor starts, nebulization begins, and aerosol is generated. Inhale and exhale gently through the mouthpiece.
11. When treatment is complete, press the power switch again to turn off the device. Then, unplug the compressor from the wall outlet.

Cleaning and Disinfection

Follow the instructions below for cleaning and disinfecting parts. Failure to do so may result in damage, ineffective inhalation, or infection.

Wash your hands thoroughly before cleaning and disinfecting the inhaler parts.

Before use, clean and disinfect the nebulizer set and accessories (masks, mouthpiece, and adapter) as follows:

• For the first time after purchase (cleaning and disinfection).
• If the device has not been used for a long time (cleaning and disinfection).
• After each use (cleaning).

Clean parts after each use and disinfect them once a week with regular use.

Cleaning the Nebulizer Set, Masks, Mouthpiece, and Adapter:

Completely disassemble the nebulizer set. Wash parts with warm water and a mild neutral detergent. Rinse them thoroughly in clean hot tap water, gently tap to remove excess water, and let them air dry in a clean place.

Cleaning the Compressor:

Ensure the electrical plug is disconnected from the electrical outlet. Wipe with a soft cloth dampened with water or a mild neutral detergent.

Removing Moisture from the Air Tubing:

If moisture remains in the air tubing, follow the procedure below. Ensure the air tubing is connected to the compressor. Disconnect the air tubing from the nebulizer set. Turn on the compressor and dry the air tubing by allowing air to pass through it.

Disinfection of Nebulizer Set, Masks, Mouthpiece, and Adapter:

Disinfect parts once a week. Parts are expected to withstand approximately 50 disinfection cycles. Replace parts if they become heavily soiled. The nebulizer set, masks, mouthpiece, and adapter can be disinfected using chemical disinfectants, such as ethanol or sodium hypochlorite (Milton), according to product instructions, and then rinsed with clean hot water. Allow to air dry.

Note: Never clean the device with benzene, thinner, or any flammable liquids. (Latex) elastic straps cannot be disinfected. Remove masks for disinfection.

Boiling:

The nebulizer set, mouthpiece, masks, and adapter can also be disinfected by boiling in a large amount of water for at least 5 minutes. After boiling, carefully remove each part, shake off excess water, and let it air dry in a clean environment.

Note: Do not boil the air tubing.

Replacing the Air Filter:

Replace the air filter if its color changes or if it has been used for more than 60 days. For purchasing filters, refer to the "Optional Accessories or Spare Parts" section.

Remove the air filter cover. Pull the air filter cover by the groove, as shown in the illustration. Remove the old filter and insert the new filter as shown in the illustration. Replace the air filter cover.

Note: Do not wash or clean the air filter. If the air filter becomes wet, replace it. A wet air filter can cause leakage.

Technical Specifications

MMAD = Mean Mass Aerodynamic Diameter

GSD = Geometric Standard Deviation

*3 ml, 0.1% Salbutamol in 0.9% NaCl solution.

[Graph description: A line graph titled "Particle Size Measurement Results using Cascade Impactor" showing cumulative percentage of sub-micron particles vs. particle diameter (Dp) in µm. Two lines are shown: "Average Value" and "Individual".]

Symbol Descriptions

• [Icon: 'i'] Consult the manual.
• [Icon: Document with arrow] User must consult the manual.
• [Icon: Person with arrow] Applied part – Type BF, protection against electric shock (leakage current).
• [Icon: Square with line] Class II Protection against electric shock.
• [Icon: IP XX] Degree of protection against ingress according to IEC 60529 standard.
• [Icon: CE mark] CE Marking.
• [Icon: LOT] Lot Number.
• [Icon: SN] Serial Number.
• [Icon: Percentage] Humidity limitation.
• [Icon: Barometer] Atmospheric pressure limitation.
• [Icon: Thermometer] Temperature limitation.
• [Icon: Power button] ON/OFF (press-press).
• [Icon: Wavy line] Alternating current.
• [Icon: Medical cross] Medical Device.
• [Icon: Calendar] Date of Manufacture.
• [Icon: UDI] Unique Device Identifier.

General Notes:

• IP classification indicates the degree of protection provided by the enclosure according to IEC 60529. The compressor is protected against the ingress of solid foreign objects 12 mm in diameter or larger (e.g., a finger), as well as against vertically falling water drops that may cause problems during normal operation.
• Technical changes reserved without prior notice.
• This device may not function if the temperature or power supply differs from the nominal values specified in the technical parameters.
• This device (compressor, nebulizer set, air tubing, mouthpiece set, child mask support adapter, adult mask, and child mask) complies with the requirements of European standard EN ISO 27427:2019 Anaesthetic and respiratory equipment – Nebulizing systems and components.

Troubleshooting

Nebulizer efficiency varies for different types of suspensions or highly viscous solutions. Refer to medication leaflets for more information.

Particle size distribution and aerosol output may vary depending on the product combination, medication, and environmental conditions such as temperature, humidity, and atmospheric pressure.

Nebulizer performance data is based on testing using adult breathing patterns and may differ from data provided for pediatric or infant populations.

[Icon: Warning symbol] If any of the following problems occur during use, first check if any other electrical devices are within 30 cm of the unit. If the problem persists, refer to the table below.

Device does not turn on:

• Check that the power plug is correctly connected to the power outlet and that the power cord is connected to the compressor socket.
• Ensure the power switch is in the ON position.

Device turns on but does not nebulize:

• Ensure the vaporizing head is attached to the nebulizer set's top cover.
• Ensure the air tubing is not pinched or bent.
• Check if the air filter is blocked or dirty. Replace as needed.
• Ensure sufficient medication has been placed in the nebulizer set.

Device suddenly stops during operation:

• The thermal fuse has tripped due to one of the following reasons:
  • The device operated in an environment with temperatures higher than 40°C.
  • The ventilator openings were covered.

Do not attempt to repair the device. Do not open or tamper with the device. The device contains no user-serviceable parts. Take the device to an authorized OMRON dealer or distributor.

In case of a serious incident when using this device, contact its manufacturer and the relevant competent authority of your member state.

Warranty

Thank you for purchasing an OMRON product. It is manufactured with great care and high-quality materials. The product is designed to provide you with the highest level of comfort, provided the instructions in the user manual are followed.

OMRON provides a 3-year warranty on this product from the date of purchase. OMRON guarantees its proper manufacturing, processing, and materials. During this warranty period, OMRON will repair or replace the defective product or defective parts free of charge for labor or parts. The warranty does not cover:

• a. Costs of transportation and transportation risks.
• b. Costs of repairs and/or damages resulting from repairs performed by unauthorized persons.
• c. Regular inspection and maintenance.
• d. Failure or wear of optional components or other accessories, such as the device itself, if not expressly covered by the warranty mentioned above.
• e. Costs due to non-recognition of a claim (will be charged).
• f. Damages of any type involving personal injury caused by accident or misuse.

If you require warranty service, contact the dealer where you purchased the product or an authorized OMRON distributor. The address can be found on the product packaging/documentation. You can also contact a specialized dealer.

Warranty repair or replacement does not extend or renew the warranty period.

The warranty can only be claimed if the complete product is returned along with the original invoice/proof of purchase issued by the seller to the customer. OMRON reserves the right to refuse warranty service if unclear information is provided.

Optional Accessories and Spare Parts

Optional Medical Accessories:

Other Optional or Spare Parts:

Important Information Regarding Electromagnetic Compatibility (EMC):

This device, manufactured by 3A HEALTH CARE S.r.l., complies with EN60601-1-2:2015 regarding electromagnetic compatibility (EMC). Further documentation in accordance with the provisions of this EMC standard is available from OMRON HEALTHCARE EUROPE at the address indicated in this user manual or at the internet address www.omron-healthcare.com.

DISPOSAL PROCEDURE (Directive 2012/19/EU – WEEE):

This product must not be treated as ordinary municipal waste but must be taken to a collection point for recycling electrical and electronic equipment. For further information, contact your local authority, the waste disposal department of your local authority, or the retailer where you purchased the product.

Manufacturer and Distributor Information

Manufacturer: 3A HEALTH CARE S.r.l., Via Marziale Cerutti, 90F/G, 25017 Lonato del Garda (BS), Italy.

Distributor: OMRON HEALTHCARE EUROPE B.V., Scorpius 33, 2132 LR Hoofddorp, NETHERLANDS. www.omron-healthcare.com.

Subsidiaries: OMRON HEALTHCARE UK LTD., Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK. www.omron-healthcare.com/distributors. OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH / OMRON SANTÉ FRANCE SAS. www.omron-healthcare.com/distributors.

Distribution and Service for SR (Slovak Republic): CELIMED s.r.o., Pri majeri 22, 831 06 Bratislava, SLOVAK REPUBLIC. www.celimed.sk.

Manufactured in Italy.