NE-C28P (NE-C28P-E) : Instruction Manual
NE-C28P (NE-C28P-E) : Instruction Manual
NE-C28P (NE-C28P-E) : Instruction Manual
Thank you for purchasing the OMRON COMP AIR. Important safety instructions Otherwise it may also result in a fire.
This product was developed in conjunction with respiratory therapists Read all the information in the instruction manual and any other literature included in General Safety Precautions:
for the successful treatment of asthma, chronic bronchitis, allergies the box before using the device. Inspect the device and parts before using them each time, and check that there are
no problems. In particular, be sure to check the following:
and other respiratory disorders. Warning:
Indicates a potentially hazardous situation which, if not avoided, could result in
- That the nozzle or air tube are not damaged.
serious injury.
This is a medical device. Operate the device only as instructed by - That the nozzle is not blocked.
(Usage)
your doctor and/or respiratory therapist. For type, dose, and regime of medication follow the instructions of your doctor or - That the compressor operates normally.
Baffle respiratory therapist. When using this device, there will be some noise and vibration caused by the pump in
If you experience any allergic reactions or other difficulties during use, stop using the the compressor. There will also be some noise caused by the emission of compressed
How the nebulizer kit works Aerosol Aerosol
device immediately and consult your doctor. air from the nebulizer kit. This is normal and does not indicate a malfunction.
Operate the device only as intended. Do not use the device for any other purpose.
The medication that is pumped up Do not use only water in the nebulizer for inhaling purposes.
Do not use the device at temperatures greater than +40°C.
TM
Medication Keep the device out of reach of unsupervised infants and children. The device may
through the medication channel is Nozzle Channel contain small pieces that can be swallowed. Make sure that the air tube is securely attached to the compressor and nebulizer kit,
mixed with compressed air which is Do not store the air tube while there is moisture or medication remaining inside. and does not come loose. Twist the air tube plug slightly when inserting it into the air
Medication Medication tube connectors to avoid the air tube disconnecting during use.
generated by a compressor pump. Do not use or store the device where it may be exposed to noxious fumes or volatile
substances. To completely isolate the device from the power source unplug the plug from the
The compressed air mixed with Do not use the device where it may be exposed to flammable gas. power source.
medication is turned into fine particles Do not cover the compressor with a blanket, towel, or any other type of cover during Keep these instructions for future reference.
use. The compressor could get hot and there is a possible risk of a burn if touched.
and sprayed when in contact with the Always dispose of any remaining medication after use, and use fresh medication each
baffle. time.
Compressed Air Do not use in anaesthetic or ventilator breathing circuits.
Do not block the ventilation slots. Never place the device where the ventilation slots
Manufacturer OMRON HEALTHCARE Co., Ltd. may be obstructed during operation. The compressor could get hot and there is a
53, Kunotsubo, Terado-cho, Muko, KYOTO, possible risk of a burn if touched.
EN 617-0002 JAPAN Store the parts in a clean location to avoid infection.
(Risk of electrical shock) Important information regarding Electro Magnetic Compatibility (EMC)
Never plug or unplug the device with wet hands. With the increased number of electronic devices such as PC’s and mobile (cellular)
EU-representative OMRON HEALTHCARE EUROPE B.V.
The compressor and power cord are not waterproof. Do not spill water or other liquids telephones, medical devices in use may be susceptible to electromagnetic interference
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS
on these parts. If liquid does spill on these parts, immediately unplug the power cord from other devices. Electromagnetic interference may result in incorrect operation of the
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Compressor Nebulizer and wipe off the liquid with gauze or other absorbent material.
Do not immerse the compressor in water or other liquid.
medical device and create a potentially unsafe situation.
Medical devices should also not interfere with other devices.
NE-C28P (NE-C28P-E) Production facility OMRON DALIAN Co., Ltd.
No. 3, Song Jiang Road,
Do not use or store the device in humid locations.
Do not operate the device with a damaged power cord or plug. In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with
Keep the power cord away from heated surfaces. the aim to prevent unsafe product situations, the EN60601-1-2:2007 standard has
Economic and Technical Development Zone, been implemented. This standard defines the levels of immunity to electromagnetic
Dalian 116600, China (Cleaning and disinfecting)
interferences as well as maximum levels of electromagnetic emissions for medical
Observe the rules below when cleaning or disinfecting parts. Failure to observe these
Instruction Manual Subsidiaries OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK
rules may result in damage, inefficient nebulization or infection. For the instructions,
devices.
This medical device manufactured by OMRON HEALTHCARE conforms to this
refer to “Cleaning and disinfecting” section.
www.omron-healthcare.com EN60601-1-2:2007 standard for both immunity and emissions.
Clean and disinfect the nebulizer kit, mask, mouthpiece or nosepiece before using
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH them when as follows: Nevertheless, special precautions need to be observed:
Gottlieb-Daimler-Strasse 10, 68165 Mannheim, GERMANY - the first time after purchase Do not use mobile (cellular) telephones and other devices, which generate strong
www.omron-healthcare.com - if the device has not been used for a long period of time electrical or electromagnetic fields, near the medical device. This may result in
- if more than one person uses the same device incorrect operation of the unit and create a potentially unsafe situation.
OMRON SANTÉ FRANCE SAS
Be sure to wash or wipe the parts after use, and ensure that they are thoroughly Recommendation is to keep a minimum distance of 7 m. Verify correct operation of
14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE
IM-NE-C28P-E-EN-03-10/2015 disinfected and dried, and stored in a clean location. the device in case the distance is shorter.
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1675597-9C Do not leave the cleaning solution to dry on the parts. Further documentation in accordance with EN60601-1-2:2007 is available at OMRON
Made in China HEALTHCARE EUROPE at the address mentioned in this instruction manual.
Indicates a potentially hazardous situation which if not avoided, may result in
Caution: minor or moderate injury, or physical damage. Documentation is also available at www.omron-healthcare.com.
(Usage)
Intended use Know your unit In order to prevent strangulation by the power cord or air tube, or injuries caused by
mishandling, please provide close supervision when this device is being used by, on
or near children or invalids.
Medical Purpose Compressor (Main Unit) x 1 Rear View Correct Disposal of This Product
Make sure that the parts are attached correctly.
This product is intended to be used for inhaling medication for respiratory Make sure that the air filter is correctly attached. (Waste Electrical & Electronic Equipment)
disorders. Nebulizer Kit Holder Make sure that the air filter is clean. If the air filter has been used for more than
60 days, replace it with a new one.
Intended User Do not tilt the nebulizer kit at an angle of greater than 45 degrees in all directions or This marking shown on the product or its literature, indicates that it should not be
shake it while in use. disposed of, with other household wastes at the end of its working life. To prevent
Legally certified medical experts, such as doctor, nurse and therapist. Do not use or store the device while the air tube is creased. possible harm to the environment or human health from uncontrolled waste disposal,
Caregiver or patient under the guidance of qualified medical experts for Use only original nebulizing parts, air tube, air filter and air filter cover. please separate this product from other types of wastes and recycle it responsibly to
Ventilation Slots
home treatment. Do not add more than 7 ml of medication to the medication tank. promote the sustainable reuse of material resources.
The user should also be capable of understanding general operation of Power Cord Do not carry or leave the nebulizer kit while the medication tank contains medication. Household users should contact either the retailer where they purchased this product,
Power Plug
NE-C28P and the content of instruction manual. Do not leave the device unattended with infants or persons who cannot express their or their local government office, for details of where and how they can return this item
consent. for environmentally safe recycling.
Ventilation Slots Do not subject the device to any strong shocks such as dropping on the floor. Business users should contact their supplier and check the terms and conditions of the
Intended Patients Air Filter Cover purchase contract. This product should not be mixed with other commercial wastes for
Do not distort the vaporiser head, or jab the nozzle of the medication tank with a pin
This product should not be used on patients, who are unconscious or are Air Tube Connector disposal.
or any sharp object.
not breathing spontaneously. Power Switch Do not insert fingers or objects inside the compressor.
Do not disassemble or attempt to repair the compressor or power cord.
Environment Do not leave the device in extreme hot or cold temperature, or under direct sunlight.
Nebulizer Kit x 1 Mouthpiece x 1 Nosepiece x 1 Do not block the air filter cover.
This product is intended for use in a medical facility, such as Hospital, clinic
Do not use the device while sleeping or if drowsy. Optional Medical Accessories
and doctor’s office, and in a room of general household.
Approved for human use only.
Cap (within the scope of EC Medical Device Directive 93/42/EEC)
The compressor may become hot during operation.
Durable period Do not touch the compressor for other than necessary operation such as turning off
Inhalation Air Inlet Product description Model
Durable periods are as follows, provided the product is used to nebulize the power while nebulizing.
saline 3 times a day for 10 minutes each time at room temperature (23°C). Inhalation Top To avoid the medication residue on the face, be sure to wipe the face after removing Nebulizer Kit & Mouthpiece Set NEB-NSET3-81E
Durable period may vary depending on usage environment. the mask.
Adult Mask (PVC) x 1 Child Mask (PVC) x 1 To avoid injury to the nose mucosa, do not squeeze the nosepiece into the back of
Frequent use of the product may shorten the durable period. Adult Mask (PVC) NEB-MSLP-E
the nose.
Compressor (Main unit) 5 years Vaporiser Head Do not block the slit between the cap and the inhalation air inlet. Child Mask (PVC) NEB-MSMP-E
Nebulizer Kit 1 year Make sure that the vaporiser head is correctly installed before use.
Do not use a damaged nebulizer kit, mouthpiece or nosepiece. Adult Mask (SEBS) NEB-MSLS-E
Mouthpiece 1 year Nozzle
(Risk of electrical shock) Child Mask (SEBS) Set NEB-MSSS-E
Nosepiece 1 year Medication Tank Always unplug the device from the power outlet after use and before cleaning.
Air Tube (PVC)/(Silicone) 1 year Plug the device into the appropriate voltage outlet. Do not overload power outlets or Mouthpiece NEB-MP-E
use extension cords.
Air Filter 60 days Do not misuse the power cord. Nosepiece NEB-NP-E
Air Tube Connector
Masks (PVC)/(SEBS) 1 year Do not wind the power cord around the compressor.
Changes or modifications not approved by OMRON HEALTHCARE will void the user Air Tube (PVC, 200cm) NEB-TP-L20E
Precautions for use Air Tube Spare Air Filters x 5 Carrying Bag x 1 warranty. Air Tube (Silicone, 100cm) NEB-TSC-L10E
(PVC, 200cm) x 1 Instruction Manual Do not pull the power cord strongly.
Warnings and cautions described in the instruction manual should be
observed. (Cleaning and disinfecting)
Warranty card Observe the rules below when cleaning or disinfecting parts. Failure to observe these Other Optional/Replacement Parts
rules may result in damage, inefficient nebulization or infection. For the instructions,
refer to “Cleaning and disinfecting” section. Product description Model
Do not use a microwave oven, dish dryer or hair dryer to dry the device or the parts.
Do not use an autoclave, EOG gas sterilizer or low temperature plasma sterilizer. Air Filters x 5 NEB-AFR-28E
How to use Cleaning and daily disinfecting Removing condensation from the air tube Technical data
Warning: Caution: Handling the Vaporiser Head If there is moisture or liquid remaining in the air tube, be sure to follow the Product Category: Nebulizers
Clean and disinfect the nebulizer kit, mask, mouthpiece or nosepiece before using Always wash the vaporiser head after each use. procedure below to remove any moisture from within the air tube. Product Description: Compressor Nebulizer
them in the following circumstances: Do not use a brush or pin to clean the vaporiser head. 1) Make sure that the air tube is connected to the air connector on the Model (code): NE-C28P (NE-C28P-E)
- the first time after purchase When disinfecting the parts by boiling, be sure to boil them in plenty of water.
- if the device has not been used for a long period of time compressor.
Do not boil vaporiser head together with objects other than applicable nebulizer accessories. Rating: 220 - 230V ~ 50Hz
- if more than one person uses the same device 2) Remove the air tube from the nebulizer kit.
For the instructions, refer to “Cleaning and disinfecting” section. 3) Turn on the compressor and pump air through the air tube to expel the Power Consumption: 192VA
Cleaning moisture. Operating Mode: Continuous Use
1. Make sure that the power switch is in the off ( ) position. Clean the parts after each use to remove residual medication. This will avoid Operating Temperature/ +10°C to +40°C / 30% to 85%RH /
inefficient nebulization or infection. Humidity/Air Pressure: 700 - 1060hPa
2. Plug the power plug into a power outlet. Changing the air filter
2 ■ Washable parts Storage and Transport -20°C to +60°C / 10% to 95%RH /
Note:
If the air filter has been used for more than 60 days, replace it with a new Temperature/Humidity/ 700 - 1060hPa
Do not place the device in a location where it is Nebulizer Kit, Masks (PVC)/(SEBS), Mouthpiece, Nosepiece,
difficult to disconnect the power cord. one. Air Pressure:
Air Tube (Silicone)
1 Wash them in warm water and mild detergent (neutral detergent). Rinse them 1. Pull the air filter cover off the compressor. Weight: Approx. 1.9kg (compressor only)
3. Remove the cap and the inhalation top from
the medication tank. thoroughly with clean hot tap water and allow to air dry in a clean place. Dimensions: Approx. 170 (W) × 103 (H) ×182 (D) mm
Vaporiser Head (compressor only)
4. Add the correct amount of prescribed Wash it with running water. Contents: Compressor, Nebulizer Kit, Air Tube (PVC,
medication to the medication tank. 200cm), Mouthpiece, Nosepiece, Adult Mask
■ Non-washable parts
(PVC), Child Mask (PVC), 5 pcs Spare Air
Compressor, Air Tube (PVC) Filters, Carring Bag, Instruction Manual,
Firstly, make sure that the power plug is unplugged from the power outlet. Wipe 2. Change the air filter. Warranty Card.
clean with a soft cloth moistened with water or mild detergent (neutral detergent). Remove the old air filter with a sharp object Classification: Class ll (Protection against electric shock),
and insert the new air filter. Type BF (Applied part)
Air Filter
Do not wash or clean the air filter. If the air filter becomes wet, replace it. IP21 (Ingress Protection)
5. Make sure that the vaporiser head is securely
Damp air filters can cause blockages. 3. Put the air filter cover back in place.
attached to the inhalation top. = Class ll Read the instruction
Make sure it is attached properly. = Type BF
equipment applied part manual carefully
Disinfecting Notes:
Always disinfect the parts after the last treatment of the day. If the parts are Use only OMRON air filters designed for this device. Do not operate without a filter. = Power off = Power on
heavily stained, replace them with new ones. Do not wash or clean the filter. If the air filter becomes wet, replace it. Damp air filters
6. Put the inhalation top back inside the can cause blockages. = Alternating = Serial
medication tank. To select a method for disinfection, refer to the table below. There is no front or back orientation for the air filters. current number
o: applicable X: not applicable Check that air filters are clean and free of dust before inserting them.
Technical data for the OMRON NE-C28P Compressor with the V.V.T.
Nebulizer Kit N-01:
(PVC, 200cm)
MMAD = Mass Median Aerodynamic Diameter
Nebulizer Kit
Mouthpiece
Nosepiece
Parts
(optional)
(optional)
(optional)
Medication Tank Capacity: 7ml maximum
Air Tube
Air Tube
Air Filter
Troubleshooting Appropriate Medication 2ml minimum - 7ml maximum
7. Attach the cap and mask, mouthpiece Disinfecting Quantities:
2 method Check the following if the device should fail during operation.
or nosepiece to the nebulizer kit tightly.
(Phthalate free)
(Phthalate free)
Connector: PP
2
Tube: Silicone
Band: Rubber
Band: Rubber
Problem Cause Remedy
Mask: SEBS
Adapter: PP
Mask: PVC
(non-latex)
(non-latex)
Note: Nebulization Rate: *Approx. 0.5ml/min (by weight loss)
Polyester
It is not necessary to attach the cap when
PVC
1 Nothing happens when the Is the power plug plugged into Check that the plug is inserted
PP
PP
PP
No nebulization or low Is there medication in the Add the correct amount of Result of cascade impactor measurements for particle size**
Alcohol nebulization rate, when the medication tank? medication to the medication tank.
Disinfecting o o o o o ** o ** X X power is on.
ethanol Is there too much/little
medication in the medication Cumulative % particle mass of sodium fluoride undersize
8. Attach the air tube. Twist the air tube plug slightly and push it firmly into Sodium tank? 100
the air tube connector. hypochlorite 90
o o o o o** o** X X Is the vaporiser head missing Attach the vaporiser head
Milton* 80
Cumulative Undersize%
or not assembled correctly? correctly.
(0.1%, 15min.) 70
Quaternary 60
ammonium Is the nebulizer kit assembled Assemble the nebulizer kit
A o o o o o** o** X X correctly? correctly. 50
Osvan* 40
(0.1%, 10min.)
Is the nozzle blocked? Make sure that the nozzle is free Individual tests 30
Chlorhexidine of blockages. Mean
20
Hibitane* o o o o o** o** X X Is the nebulizer kit tilted at a Make sure that the nebulizer kit is 10
00$'ȝP
(0.5%, 30min.) sharp angle? not tilted at an angle of more than
45 degrees. 0
Amphoteric 0.1 1 10 100
9. Hold the nebulizer kit as Surfactant Is the air tube connected Make sure that the air tube 3DUWLFOH6L]H'SȝP
o o o o o** o** X X
indicated on the right. Tego 51* correctly? is correctly connected to the
(0.2%, 15min.) compressor and nebulizer kit. * Measured by OMRON HEALTHCARE Co., Ltd.
Follow the instructions of your
doctor or respiratory therapist. Is the air tube folded or Make sure that the air tube does ** Independently measured by Prof. Dr. Hiroshi Takano, Department of Chemical
B Boiling o o o o o** X X X Engineering and Materials Science, Faculty of Science and Engineering, Doshisha
damaged? not contain kinks.
* an example of commercially available disinfectant. (The concentration and residence University, Kyoto, Japan, according to EN 13544-1:2007+A1:2009.
time specified in the table are under the conditions where the service life of the parts Is the air tube blocked? Make sure that the air tube is free
is tested with each disinfectant used as described in its instruction manual. Please of blockages. Notes:
Right angle note that the testing was not performed for the purpose of ensuring the effectiveness Subject to technical modification without prior notice.
Caution: of the disinfectants. There is no intention of suggesting that such disinfectants be Is the air filter dirty? Replace the air filter with a new
used. Conditions of use and ingredients of disinfectant vary for manufacturers. one.
This OMRON product is produced under the strict quality system of OMRON
Do not tilt the nebulizer kit at an Please read the instruction manuals carefully before use and apply disinfectant to HEALTHCARE Co., Ltd., Japan.
angle of greater than 45 degrees each part in an appropriate way. Please notice that service life of the parts may be The compressor is Is the air filter cover attached Attach the air filter cover correctly. The device may not work if the temperature and voltage conditions are different to
shorter depending on conditions, environments and frequency of use.)
in all directions. Medication may ** Remove the rubber band from mask before disinfecting.
abnormally loud. correctly? those defined in the specifications.
flow into the mouth or it may result The device fulfils the provisions of the EC directive 93/42/EEC (Medical Device
The compressor is very hot. Is the compressor covered? Do not cover the compressor with
in not nebulizing effectively. A. Use a commercially available disinfectant. Follow the instructions Directive) and the European Standard EN13544-1:2007+A1:2009, Respiratory
any type of cover during use.
provided by the disinfectant manufacturer. therapy equipment - Part1: Nebulizing systems and their components.
10.Press the power switch to the on ( ) position. As the compressor Are the ventilation slots Do not block the ventilation slots. Performance may vary with medication such as suspensions or high viscosity. See
Note: Never clean with benzene, thinner or a flammable
starts, nebulization begins and aerosol is generated. blocked? medication supplier’s data sheet for further details.
chemical.
Inhale the medication.
B. Parts may be boiled between 15 to 20 minutes. Note: If the suggested remedy does not solve the problem, do not try to repair the device
11. When treatment is complete, turn the power off and unplug the - the device is not user serviceable. Return the device to an authorized OMRON
compressor from the power outlet. After boiling, carefully remove the parts, shake off excess retail outlet or distributor.
water and allow to air dry in a clean environment.