OMRON COMP A-I-R Compressor Nebulizer

Model NE-C28P

Introduction

Thank you for purchasing the OMRON COMP AIR. This product was developed in conjunction with respiratory therapists for the successful treatment of asthma, chronic bronchitis, allergies and other respiratory disorders. The compressor forces air to the nebulizer kit. When the air enters the nebulizer kit, it converts the prescribed medication into an aerosol of microscopic droplets that can easily be inhaled.

This is a medical device. Operate the device only as instructed by your doctor and/or respiratory therapist.

Intended use

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

Intended User:

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

Environment: This product is intended for use in a medical facility, such as a hospital, clinic, doctor's office, and in a room of a general household.

Durable period: Durable periods are as follows, provided the product is used to nebulize saline 3 times a day for 10 minutes each time at room temperature (23°C). Durable period may vary depending on usage environment.

Precautions for use: Warnings and cautions described in the instruction manual should be observed.

Important safety instructions

Read all the information in the instruction manual and any other literature included in the box before using the device. When using an electrical product, especially when children are present, basic safety precautions should always be followed including the following:

⚠️ Warning:

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

(Usage)

(Risk of electrical shock)

Read and follow the "Important information regarding Electro Magnetic Compatibility (EMC)" (page 26).

⚠️ Caution:

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

(Usage)

To avoid injury to the nose mucosa, do not squeeze the nosepiece into the back of the nose.

(Risk of electrical shock)

General Safety Precautions:

Read and follow the "Correct Disposal of This Product" (page 26) when disposing of the device and any used accessories or optional parts.

Save these instructions for future reference.

1. Know your unit

A. Compressor (Main Unit)

B. Air Tube (PVC, 200cm)

C. Nebulizing Parts

D. Inhalation Attachments

E. Nebulizer Kit

Diagram Description: A diagram shows the OMRON COMP A-I-R compressor unit (labeled A), with its power switch (A1), air tube connector (A2), air filter cover (A3), nebulizer kit holder (A4), ventilation slots (A5), power cord (A6), and power plug (A7). The air tube (B) is shown with its plugs (B1, B2). Nebulizing parts (C) are indicated. Inhalation attachments (D) include a mouthpiece (D1), adult mask (PVC) (D2), child mask (PVC) (D3), and nosepiece (D4). The nebulizer kit (E) is shown disassembled, with its cap (E1), inhalation air inlet (E2), inhalation top (E3), vaporiser head (E4), medication tank (E5), nozzle (E6), and air tube connector (E7). A rear view of the compressor shows the power cord (A6) and ventilation slots (A5).

Accessories

F. Spare Air Filters x 5

G. Carrying Bag

H. Instruction Manual

I. Warranty Card

2. Guide to using the COMP AIR

Preparing the Nebulizer for Use - Section 3 (page 10-13)

⚠️ Warning:

Clean and disinfect the nebulizer kit, mouthpiece, and nosepiece or masks before using them for the first time after purchase, if the device has not been used for a long period of time, or if more than one person uses the same device.

Taking Medication - Section 4 (page 14-16)

⚠️ Caution:

Cleaning Parts After Use - Section 5 (page 17-20)

Note: Failure to clean the nebulizing parts after use may lead to infection.

How the nebulizer kit works

The medication that is pumped up through the medication channel is mixed with compressed air which is generated by a compressor pump. The compressed air mixed with medication is tuned into fine particles and sprayed by being impacted to the baffle.

Diagram Description: A diagram illustrates how the nebulizer kit works. Compressed air from the compressor pump enters the medication channel, mixes with medication, and is converted into fine aerosol particles. These particles are sprayed via the nozzle against a baffle. The diagram shows "Compressed Air" entering from the bottom, mixing with "Medication" in the "Medication Channel", forming "Aerosol" which is then sprayed from the "Nozzle" against a "Baffle".

3. Preparing the nebulizer for use

⚠️ Warning:

Clean and disinfect the nebulizer kit, mouthpiece, and nosepiece or masks before using them for the first time after purchase, if the device has not been used for a long period of time, or if more than one person uses the same device.

For directions on cleaning and disinfecting, refer to Section 5 (page 17-20).

Note: Make sure that the air filter is changed regularly. Refer to Section 7 "Changing the air filter" (page 22).

  1. Make sure that the power switch is turned off. Check that the power switch is in the ⚪ position.
  2. Plug the power plug into a power outlet.
  3. Remove the mouthpiece and cap from the nebulizer kit.
  4. 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.
  5. Add the correct amount of prescribed medication to the medication tank.

    ⚠️ Caution:

    The capacity of the medication tank is 2 to 7 ml. Scales on the nebulizer kit are for reference only. The scale on the outside of the tank is with no vaporiser head in place. Please use the scale on your syringe or vial for accurate measurement of medication.

  6. Make sure that the vaporiser head is securely attached to the inhalation top.
  7. Put the inhalation top back inside the medication tank.
    1. Align the protrusion on the inhalation top with the indent on the medication tank, as shown.
    2. Rotate the inhalation top clockwise and align with the medication tank until they click in place.
  8. Attach the desired inhalation attachment, as described below.

    Attaching the mouthpiece

    1. Attach the cap to the inhalation air inlet.
    2. Attach the mouthpiece to the inhalation top.

    Attaching the adult mask (PVC)

    Attach the mask to the inhalation top. Note: If the amount of aerosol is too great, attach the cap.

    Attaching the child mask (PVC)

    1. Attach the cap to the inhalation air inlet.
    2. Attach the child mask to the inhalation top. Note: If the amount of aerosol is too small, it is not necessary to place the cap.

    Attaching the nosepiece

    1. Attach the cap to the inhalation air inlet.
    2. Attach the nosepiece to the inhalation top.
  9. Attach the air tube.

    Twist the air tube plugs slightly and push them firmly into the air tube connectors.

    Notes:

    • Make sure that the air tube is securely attached to the compressor (main unit) and nebulizer kit, and does not come loose. Twist the air tube plug slightly when inserting it into the air tube connectors to avoid the tube disconnecting during use.
    • Take care not to spill the medication when attaching the air tube. Keep the nebulizer kit upright.
    • Use the nebulizer kit holder as a temporary holder for the nebulizer kit.

4. Taking medication

  1. Hold the nebulizer kit as indicated on the right.

    ⚠️ Caution:

    Do not tilt the nebulizer kit at an angle of greater than 45° in all directions. Medication may flow into the mouth.

    Diagram Description: Illustrations show correct (right angle) and incorrect (45°) angles for holding the nebulizer kit, with a person using the device.

  2. Press the power switch to the ❘ (on) position. The compressor starts and nebulization starts.

    Note: Observe whether aerosol is generated.

    To stop nebulization: Press the power switch to the ⚪ (off) position.

⚠️ Warning:

Do not block the ventilation slots on the compressor. This could result in the compressor overheating or malfunctioning.

⚠️ Caution:

Note: Do not leave the compressor on for a long period of time. This could result in the compressor overheating or malfunctioning.

Inhale medication according to your doctor's and/or health care adviser's instructions.

Using the mouthpiece

Insert the mouthpiece into your mouth and inhale the medication breathing normally. Exhale as normal through the mouthpiece.

Diagram Description: An illustration shows a person using the mouthpiece correctly.

Using the nosepiece

Inhale the medication through the nosepiece, as shown, and exhale through the mouth.

Diagram Description: An illustration shows a person using the nosepiece correctly.

Using the adult mask (PVC)

Attach the mask so that it covers your nose and mouth and inhale the medication. Exhale through the mask. Note: If the amount of aerosol is too great, attach the cap.

Diagram Description: An illustration shows a person wearing the adult mask correctly.

Using the child mask (PVC)

Attach the mask so that it covers your nose and mouth and inhale the medication. Exhale through the mask.

Diagram Description: An illustration shows a child wearing the child mask correctly.

When treatment is complete, turn the power off. Check that there is no condensation or moisture in the air tube and unplug the device from the power outlet.

⚠️ Warning:

Condensation may occur in the air tube. Do not store the air tube while it contains condensation or moisture. This could result in infection via bacteria.

If there is moisture or liquid remaining in the air tube, be sure to follow the procedure below to remove any moisture from within the air tube:

  1. Make sure that the air tube is still connected to the air connector on the compressor.
  2. Unplug the air tube from the nebulizer kit.
  3. Turn on the compressor and pump air through the air tube to expel the moisture.

5. Cleaning and daily disinfecting

5.1 Cleaning

Following the cleaning instructions after each use will prevent any remaining medication in the tank from drying, resulting in the device not nebulizing effectively and also for preventing infections.

⚠️ Warning:

Thoroughly rinse the nebulizer kit and the mask, nosepiece, or mouthpiece with clean hot tap water after each use, and disinfect the parts of the nebulizer kit and applicable inhalation attachments after the last treatment of the day.

Note: Do not start operation before the cleaned parts are completely dried.

  1. Make sure that the power switch is in the ⚪ (off) position.
  2. Unplug the power cord from the electrical outlet.
  3. Remove the nebulizer kit from the air tube and disassemble the nebulizer kit. Refer to Section 3 (page 10-13).
  4. Discard any remaining medication in the medication tank.
  5. Wash all the nebulizing parts in warm water and mild detergent and rinse in clean hot tap water. For instructions on how to disinfect the parts, see the following section.
  6. After cleaning and disinfecting the parts, rinse them thoroughly with clean water and allow the parts to air dry in a clean environment.

If the compressor is dirty, wipe it clean with a soft cloth moistened with water or mild detergent.

⚠️ Caution:

The compressor is not waterproof.

If the outside of the air tube is dirty, wipe it clean with a soft cloth moistened with water or mild detergent.

Reassemble the nebulizer kit. Put the parts in a dry, sealed bag and place in the storage pocket of the carrying bag.

Note: Nebulizer kit should be replaced after using for one year.

5.2 Disinfecting the nebulizing parts

Always clean before disinfection. Always disinfect the medication tank, mouthpiece, and other nebulizing parts after the last treatment of the day. For appropriate method of disinfecting each part, refer to page 20.

A. Use a commercially available disinfectant. Follow the instructions provided by the disinfectant manufacturer.

  1. Submerge the parts in the cleansing solution for the specified period.
  2. Remove the parts and discard the solution.
  3. Rinse the parts with clean hot tap water, shake off excess water, and allow to air dry in a clean environment.

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

Note: Do not boil Air tube, Adult mask (PVC), Child mask (PVC), Air filter, and Air filter cover.

⚠️ Caution:

Do not use an autoclave, EOG gas disinfection, or low-temperature plasma sterilizer to disinfect the device.

Handling the Vaporiser Head

The vaporiser head is an important part that is used to vaporise medication. Be sure to observe the following precautions when handling it.

⚠️ Caution:

Diagram Description: A diagram shows the vaporiser head with its baffle.

Disinfection Methods Table

Use the table below as a guideline to select a method for disinfecting.

Parts Model Materials Boiling Alcohol Disinfecting ethanol Sodium hypochlorite (0.1%) Quaternary ammonium Osvan* (0.1%) Chlorhexidine Hibitane* (0.5%) Amphoteric surfactant Tego* (0.2%)
Mouthpiece C28-3P-E PP ✔️ ✔️ ✔️ ✔️ ✔️ ✔️
Nebulizer Kit Set C801S-NSET3-E Cap: PP
Inhalation Top: PP
Vaporiser Head: PC
Medication Tank: PP
✔️ ✔️ ✔️ ✔️ ✔️ ✔️
Nosepiece C28-7-E PP ✔️ ✔️ ✔️ ✔️ ✔️ ✔️
Air Filter C28-2-E Polyester
Air Filter Cover C28-5-E ABS ✔️ ✔️ ✔️ ✔️ ✔️
Adult Mask (PVC) C28-8-E Mask: PVC
Band: Rubber (non-latex)
✔️ ✔️ ✔️ ✔️ ✔️
Child Mask (PVC) C28-9-E Mask: PVC
Band: Rubber (non-latex)
✔️ ✔️ ✔️ ✔️ ✔️
Adult Mask (SEBS) (optional) U10-1P-E Mask: SEBS
Band: Rubber (non-latex)
✔️ ✔️ ✔️ ✔️ ✔️ ✔️
Child Mask (SEBS) Set (optional) U10-2P-E Adapter: PP ✔️ ✔️ ✔️ ✔️ ✔️ ✔️
Air Tube (PVC, 200cm) NEB-TP-L20E PVC (Phthalate free)
Air Tube (Silicone, 100cm) (optional) C28-6-E Tube: Silicone
Connector: PP
✔️ ✔️ ✔️ ✔️ ✔️ ✔️

* an example of commercially available disinfectant.

6. Maintenance and storage

To keep your device in the best condition and protect the device from damage, follow these directions:

⚠️ Caution:

Notes:

Always transport the device in its carrying bag, and store the device in the bag if it will not be used for a long period.

Diagram Description: Illustrations show bottles labeled "Thinner" and "Benzene" with a cross mark, indicating they should not be used for cleaning. An illustration of the OMRON carrying bag is shown.

7. Changing the air filter

If the air filter has changed colour, or has been used on average for more than 60 days, replace it with a new one.

  1. Pull the air filter cover off the compressor.
  2. Change the air filter.

    Remove the old air filter with a sharp object, such as a toothpick, and insert the new air filter.

  3. Put the air filter cover back in place.

Notes:

8. Troubleshooting

Check the following if your unit should fail during operation. You can also refer to the pages of this manual for complete instructions.

Symptom Cause Remedy
Nothing happens when the power switch is pressed. Is the power plug plugged into an electrical outlet? Check that the plug is inserted in an electrical outlet. Unplug then reinsert the plug if necessary.
No nebulization or low nebulization rate, when the power is on. Is there medication in the medication tank? Add the correct amount of medication to the medication tank.
Is there too much/little medication in the medication tank? Add the correct amount of medication to the medication tank.
Is the vaporiser head missing and not assembled correctly? Attach the vaporiser head correctly.
Is the nebulizer kit assembled correctly? Assemble the nebulizer kit correctly.
Is the nozzle blocked? Make sure that the nozzle is free of blockages.
Is the nebulizer kit tilted at a sharp angle? Make sure that the nebulizer kit is not tilted at an angle of more than 45 degrees.
Is the air tube connected correctly? Make sure that the air tube is correctly connected to the compressor and nebulizer kit.
Is the air tube folded or damaged? Make sure that the air tube does not contain kinks.
Is the air tube blocked? Make sure that the air tube is free of blockages.
Is the air filter dirty? Replace the air filter with a new one.
The device is abnormally loud. Is the air filter cover attached correctly? Attach the air filter cover correctly.
The device is very hot. Are the ventilation slots blocked? Do not block the ventilation slots.

Note: If the suggested remedy does not solve the problem, do not try to repair the device - no parts of the unit are user serviceable. Return the unit to an authorized OMRON retail outlet or distributor.

9. Technical data

Product Description: Compressor Nebulizer

Model: NE-C28P (NE-C28P-E)

Electrical: 220 - 240V, 50/60 Hz

Power Consumption: 192VA

Operating Temperature/ Humidity: +10°C to +40°C 30% to 85% RH

Storage Temperature/ Humidity/Air Pressure: -20°C to +60°C 10% to 95% RH 700 - 1060 hPa

Weight: Approx. 1.9kg (compressor only)

Dimensions: Approx. 170 (W) × 103 (H) × 182 (D) mm

Contents: Compressor, Nebulizer Kit, Air Tube (PVC, 200cm), 5 pcs Spare Air Filters, Mouthpiece, Adult Mask (PVC), Child Mask (PVC), Nosepiece, Carrying Bag, Instruction Manual, Warranty Card.

Classification: Class II equipment, Type B applied part

Diagram Description: Symbols are shown for "= Class II equipment", "= Type B applied part", "= Power off ⚪", and "= Power on ❘". The CE0197 mark is also present.

Notes:

Technical data for the OMRON NE-C28P Compressor with the OMRON V.V.T. (Virtual Valve Technology) Nebulizer kit N-01:

Particle Size: *MMAD **approximately 3µm

Medication Tank Capacity: 7 ml maximum

Appropriate Medication Quantities: 2 ml minimum - 7 ml maximum

Sound: Noise level (at 1 m distance) 60 dB

Nebulization Rate: 0.5 ml/min (by weight loss)

Aerosol Output: **0.4 ml (2ml, 1%NaF)

Aerosol Output Rate: **0.09 ml/min (2ml, 1%NaF)

Graph Description: A line graph titled "Result of cascade impactor measurements for particle size**". The X-axis represents "Particle Size Dp (µm)" ranging from 0.1 to 100. The Y-axis represents "Cumulative Undersize %" ranging from 0 to 100. Two lines are plotted: "Individual tests" and "Mean". A label indicates "MMAD: 3µm".

*MMAD = Mass Median Aerodynamic Diameter

**Independently measured by Prof. Dr. Hiroshi Takano, Department of Chemical Engineering and Materials Science, Faculty of Science and Engineering, Doshisha University, Kyoto, Japan, according to EN13544-1:2007+A1:2009

Notes:

Important information regarding Electro Magnetic Compatibility (EMC)

With the increased number of electronic devices such as PC's and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation.

Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the EN60601-1-2:2007 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices.

This medical device manufactured by OMRON HEALTHCARE conforms to this EN60601-1-2:2007 standard for both immunity and emissions.

Nevertheless, special precautions need to be observed:

Further documentation in accordance with EN60601-1-2:2007 is available at OMRON HEALTHCARE EUROPE at the address mentioned in this instruction manual. Documentation is also available at www.omron-healthcare.com.

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

Diagram Description: A symbol showing a crossed-out wheeled bin indicates "Correct Disposal of This Product (Waste Electrical & Electronic Equipment)".

This marking shown on the product or its literature indicates that it should not be disposed of with other household wastes at the end of its working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this product from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources.

Household users should contact either the retailer where they purchased this product, or their local government office, for details of where and how they can return this item for environmentally safe recycling.

Business users should contact their supplier and check the terms and conditions of the purchase contract. This product should not be mixed with other commercial wastes for disposal.

10. Accessories

Omron V.V.T. Nebulizer Kit N-01 Set

Model: C801S-NSET3-E
Order No.: 9515573-6

Air Tube (PVC, 200cm)

Model: NEB-TP-L20E
Order No.: 9520606-3

Mouthpiece

Model: C28-3P-E
Order No.: 9956273-5

Air Tube (Silicone, 100cm)

Model: C28-6-E
Order No.: 9956269-7

Nosepiece

Model: C28-7-E
Order No.: 9956274-3

Adult Mask (PVC)

Model: C28-8-E
Order No.: 9956275-1

Child Mask (PVC)

Model: C28-9-E
Order No.: 9956276-0

Adult Mask (SEBS)

Model: U10-1P-E
Order No.: 9956312-0

Child Mask (SEBS) Set

Model: U10-2P-E
Order No.: 9956281-6

Air Filters (x 5)

Model: C28-2-E
Order No.:9956271-9

Manufacturer Information

Manufacturer: OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN

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

Production facility: OMRON (DALIAN) Co., Ltd.
Dalian, CHINA

Subsidiary: OMRON HEALTHCARE UK LTD.
Opal Drive
Fox Milne, Milton Keynes, MK15 0DG, U.K.

OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
John-Deere-Str. 81a
68163 Mannheim, GERMANY
www.omron-medizintechnik.de

OMRON SANTÉ FRANCE SAS
14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE

Made in China

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