Omron COMP A-I-R C21 basic User manual

EN
9701707-1D_NE-C803-RU_IM_M02_191220.pdf
Compressor Nebulizer
C21 basic (NE-C803-RU)
Instruction Manual
IM-NE-C803-RU-05-11-2019
9701707-1D
Issue Date: 2020-03-02
20A0047
RU

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Introduction
Thank you for purchasing the OMRON C21 basic.
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 the device only as instructed by your doctor and/or
respiratory therapist.
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 medication is turned into fine particles and
sprayed when in contact with the compressed air.
Aerosol
Nozzle
Compressed Air
Medication Channel
Medication
Before using the device
Contents
Before using the device
Introduction................................................................................................................. 2
Intended use............................................................................................................... 3
Important safety instructions....................................................................................... 4
Know your unit............................................................................................................ 7
Optional Medical Accessories..................................................................................... 8
Other Optional/Replacement Parts............................................................................. 8
Operating instructions
How to use.................................................................................................................. 9
Care and maintenance
Cleaning and disinfecting.......................................................................................... 13
Removing condensation from the air tube................................................................ 15
Changing the air filter................................................................................................ 15
Troubleshooting ........................................................................................................ 16
Technical data........................................................................................................... 17

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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 doctor, nurse and therapist.
• Caregiver or patient under the guidance of qualified medical experts for home
treatment.
• The user should also be capable of understanding general operation of C21 basic 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, such as Hospital, clinic and doctor’s
office, and in a room of general household.
Durable period
Durable periods are as follows, 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 period may vary depending on usage environment.
Frequent use of the product may shorten the durable period.
Compressor (Main unit) 5 years
Nebulizer Kit 1 year
Mouthpiece 1 year
Nosepiece 1 year
Air Tube (PVC, 100cm) 1 year
Air Filter 60 days
Mask (PVC) (SEBS) 1 year
Precautions for use
Warnings and cautions described in the instruction manual should be observed.

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Important safety instructions
Read all the information in the instruction manual and any other literature included in the box before
using the device.
Warning: Indicates a potentially hazardous situation which, if not avoided, could result in serious injury.
(Usage)
• For type, dose, and regime of medication follow the instructions of your doctor or respiratory therapist.
• If you experience any allergic reactions or other difficulties during use, stop using 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. The device 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 type of cover during use.
• Always dispose of any remaining medication after use, and use fresh medication each time.
• Do not use in anaesthetic or ventilator breathing circuits.
• Store the 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 the AC adapter are not waterproof. Do not spill water or other liquids on these parts.
If liquid does spill on these parts, immediately unplug the AC adapter and wipe off the liquid with gauze or
other absorbent material.
• 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 original OMRON AC adapter. Use of unsupported AC adapter may damage the device.
(Cleaning and disinfecting)
Observe the rules below when cleaning or disinfecting parts. Failure to observe these rules may result
in damage, inefficient nebulization or infection. For the instructions, refer to “ Cleaning and disinfecting ”
section.
• Clean and disinfect the nebulizer kit, mask, mouthpiece or nosepiece before using them when as
follows:
- the first time after purchase.
- if the device has not been used for a long period of time
- if more than one person uses the same device
• Be sure to wash or wipe the parts after use, and ensure that they are thoroughly disinfected and dried,
and stored in a clean location.
• Do not leave the cleaning solution to dry on parts.

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Caution: Indicates a potentially hazardous situation which if not avoided, may result in minor or
moderate injury, or physical damage.
(Usage)
• 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 used by, on, or near children or invalids.
• Make sure that the parts are attached correctly.
• Make sure that the air filter is correctly attached.
• 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.
• Do not tilt the nebulizer kit at an angle of greater than 45 degrees in all directions or shake it while in use.
• Do not use or store the device while the air tube is creased.
• Use only original 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 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 temperature, 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 for other than necessary operation such as turning off the power while
nebulizing.
• To avoid the medication residue on the face, be sure to wipe the face after removing the mask.
• To avoid injury to the nose mucosa, do not squeeze the nosepiece into the back of the nose.
• Do not use a damaged nebulizer kit, mouthpiece or nosepiece.
• While using this device, make sure that no mobile phone or any other electrical devices that emit
electromagnetic fields is within 30cm. This may result in degradation of performance of the device.
(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 the power cord of AC adapter.
• Do not wind the power cord around the compressor or AC adapter.
• Do not pull the power cord of AC adapter strongly.
• 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)
Observe the rules below when cleaning or disinfecting parts. Failure to observe these rules may result in
damage, inefficient nebulization or infection. For the instructions, refer to “Cleaning and disinfecting” section.
• Do not use a microwave oven, dish dryer or hair dryer to dry the device or the parts.

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• Do not use an autoclave, EOG gas sterilizer or low temperature plasma sterilizer.
• When disinfecting parts by boiling, make sure that the container does not boil dry. Otherwise it may also
result in a fire.
General Safety Precautions:
• Inspect the device before using them each time, and check that there are no problems. In particular, be
sure to check the following:
- That the vaporizer head, nozzle or air tube are not damaged.
- That the nozzle is not blocked.
- That the compressor operates normally.
• When using this device, there will be some noise and vibration caused by the pump in the compressor.
There will also be some noise caused by the emission of compressed 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.
• Do not use the device at temperatures greater than +40°C.
• Make sure that 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.

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Know your unit
AC Adapter
(HHP-CM01) x 1
Storage Bag x 1
Instruction Manual
Warranty Card
Rear View
Power Connector
Air Filter Cover
*Air filter inside
Compressor (Main Unit) x 1
Nebulizer Kit Holder Air Tube Connector
Power Switch
Spare Air Filters x 5Air Tube
(PVC, 100cm) x 1
Mouthpiece x 1
Child Mask (PVC) x 1
Adult Mask (PVC) x 1
Nebulizer Kit x 1
Air Tube Connector
Inhalation Top
Vaporizer Head
Nozzle
Medication Tank
Nosepiece x 1

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Optional Medical Accessories
Product description Model
Nebulizer Kit & Mouthpiece Set NEB-NSET3-83E
Adult Mask (PVC) NEB-MSLP-E
Child Mask (PVC) NEB-MSMP-E
Adult Mask (SEBS) NEB-MSLS-E
Child Mask (SEBS) & Mask Adapter set NEB-MSSS-E
Mouthpiece NEB-MP-E
Nosepiece NEB-NP-E
Air Tube (PVC, 100cm) NEB-TP-82E
AC Adapter HHP-CM01
Other Optional/Replacement Parts
Product description Model
Air Filters x 5 NEB-AFR-30E
Operating instructions

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Operating instructions
How to use
Warning:
Clean and disinfect the nebulizer kit, mask, mouthpiece or nosepiece before using them
when as follows:
- the first time after purchase.
- if the device has not been used for a long period of time
- if more than one person uses the same device
For the instructions, refer to “Cleaning and disinfecting” section.
1. Make sure that the power switch is in the off ( ) position.
2. Connect the AC adapter to the compressor
and 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 together with
vaporizer head from the medication tank.
Note:
If the vaporizer head came off the inhalation top and fell into the medication tank,
remove it out of the tank.
4. Add the correct amount of prescribed
medication to the medication tank.

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5. Make sure that the vaporizer head is
securely attached to the inhalation top.
Note:
The sizes of the left- and right-hand
attached parts of the vaporizer head are
not the same. If the vaporizer head is not
attached in the correct orientation, it will not
nebulize correctly.
6. 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
until the arrow mark on it and the
alignment mark on the medication
tank are aligned, and they click in
place.
Arrow mark
Alignment
mark
Small Large

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7. Attach the mask, mouthpiece or
nosepiece to the nebulizer kit tightly.
Note:
Make sure that these attachments are
fitted in such a way that the handle is
positioned away from the patient.
Otherwise, medication may be sprayed
on patient’s skin or clothes.
8. Attach the air tube.
Push the air tube plugs firmly into the air tube
connectors.
Handle Handle
The nebulizer kit can be fixed on the compressor.

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Care and maintenance
9. Hold the nebulizer kit as indicated on the right.
Follow the instructions of your doctor or respiratory
therapist. Exhale as normal through mouthpiece,
mask or through the nose.
Caution:
Do not tilt the nebulizer kit at an angle of greater than 45
degrees in all directions. Medication may flow into the
mouth or it may result in not nebulizing effectively.
10.
Press the power switch to the on ( ) position. As the compressor starts,
nebulization begins and aerosol is generated.
Inhale the medication.
11. When treatment is complete, turn the 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.
Caution:
Do not pull the power cord.
Damage may be caused.
Right angle
45°45°
Compressor
Power plug

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Care and maintenance
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 the parts by boiling, be sure to boil them in plenty of water.
• Do not boil vaporizer head together with objects other than applicable nebulizer
accessories.
Cleaning
Clean the parts after each use to remove residual medication. This will avoid inefficient
nebulization or infection.
■Washable parts
• Nebulizer Kit (Inhalation top, Medication tank), Mask (PVC)/(SEBS), Mouthpiece,
Nosepiece
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.
■Non-washable parts
• Compressor, Air Tube
Firstly, make sure that the power plug is unplugged from the power outlet. Wipe clean
with a soft cloth moistened with water or mild detergent (neutral detergent).
• Air Filter
Do not wash or clean the air filter. If the air filter becomes wet, replace it. Damp air
filters can cause blockages.
Disinfecting
Disinfect the parts once a week. If the parts are heavily stained, replace them with new
ones.
To select a method for disinfection, refer to the table on page 14.
9. Hold the nebulizer kit as indicated on the right.
Follow the instructions of your doctor or respiratory
therapist. Exhale as normal through mouthpiece,
mask or through the nose.
Caution:
Do not tilt the nebulizer kit at an angle of greater than 45
degrees in all directions. Medication may flow into the
mouth or it may result in not nebulizing effectively.
10.
Press the power switch to the on ( ) position. As the compressor starts,
nebulization begins and aerosol is generated.
Inhale the medication.
11. When treatment is complete, turn the 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.
Caution:
Do not pull the power cord.
Damage may be caused.
Right angle
45°45°
Compressor
Power plug

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o: applicable X: not applicable
Disinfecting
method
Parts
Mouthpiece
Nosepiece
Nebulizer Kit
Adult Mask (SEBS)
(optional)
Child Mask (SEBS)
(optional)
Adult Mask (PVC) Child Mask (PVC)
Air Tube
(PVC, 100cm)
Air Filter
Materials
PP PP PP
(Vaporizer Head: PC)
Mask: SEBS
Band: Rubber***
Adapter: PP
Mask: PVC
(Phthalate free)
Band: Rubber***
PVC
(Phthalate free)
Polyester
A
Alcohol o o o o** o** X X
Disinfecting ethanol
Sodium hypochlorite
o o o o** o** X X
Milton*
(0.1%, 15min.)
BBoiling o o o o** X X X
A. Use a commercially available disinfectant. Follow the
instructions provided by the disinfectant manufacturer.
Note: Never clean with benzene or thinner.
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.
* An example of commercially available disinfectant. (The concentration and residence time specified in the table
are under the conditions where the service life of the parts is tested with each disinfectant used as described in its
instruction manual. Please note that the testing was not performed for the purpose of ensuring the effectiveness
of the disinfectants. There is no intention of suggesting that such disinfectants be used. Conditions of use and
ingredients of disinfectant vary for manufacturers. Please read the instruction manuals carefully before use and
apply disinfectant to each part in an appropriate way. Please notice that service life of the parts may be shorter
depending on conditions, environments and frequency of use.)
** Remove the rubber band from mask before disinfecting.
***The band is not made with natural rubber latex.

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Removing condensation from the air tube
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 connected to the air connector on the compressor.
2) Remove the air tube from the nebulizer kit.
3) Turn on the compressor and pump air through the air tube to expel the moisture.
Changing the air filter
If the air filter has been used 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.
3. Put the air filter cover back in place.
Make sure it is attached properly.
Notes:
• Use only OMRON air filters designed for this device. Do not operate without air filter.
• Do not wash or clean the air filter. If the air filter becomes wet, replace it. Damp air filters
can cause blockages.
• There is no front or back orientation for the air filters.
• Check that air filters are clean and free of dust before inserting them.

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Troubleshooting
In case of any of the below problems occur during use, first check that no other electrical
device is within 30cm. If the problem persists, please refer to the table below.
Problem Cause Remedy
Nothing happens
when the power switch
is pressed.
Is the AC adapter connected
correctly to a power outlet and
the compressor?
Check that the AC adapter is connected
to a power outlet and the compressor.
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?
Is the vaporizer head missing
or not assembled correctly? Attach the vaporizer 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? Make sure that the air tube is not twisted
or bended.
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 compressor is
abnormally loud.
Is the air filter cover attached
correctly? Attach the air filter cover correctly.
The compressor is
very hot.
Is the compressor being
covered?
Do not cover the compressor during
operation.
Note: If the suggested remedy does not solve the problem, do not try to repair the
device - the device are not user serviceable. Return the device to an authorized
OMRON retail outlet or distributor.

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Technical data
Product Description OMRON Compressor Nebulizer
Model (code) C21 basic (NE-C803-RU)
Rating (AC adapter) 100 - 240V 50/60Hz 0.12 - 0.065A
Rating (Compressor Nebulizer) 6V 0.7A
Operating
temperature/
humidity/
air pressure
10 to 40°C
30 to 85%RH (non-condensing)
700 to 1060hPa
Storage and transport
temperature/
humidity/
air pressure
-20 to 60°C
10 to 95%RH (non-condensing)
700 to 1060hPa
Weight Not more than 180g (compressor only)
Not more than 602g (complete package)
Dimensions Not more than 85 (W) × 43 (H) ×115 (D) mm (compressor only)
Classifications Class II equipment (Protection against electric shock),
Type BF (Applied part); Mouthpiece, Mask, Nosepiece,
IP21 (Ingress Protection)
Package Contents Compressor, Nebulizer Kit, air tube (PVC 100cm),
Mouthpiece, Nosepiece, Adult Mask (PVC), Child Mask (PVC),
AC Adapter (HHP-CM01), 5 pcs Spare Air Filters, Storage
Bag, Instruction Manual, Warranty Card
Notes:
• This OMRON product is produced under the strict quality system of OMRON
HEALTHCARE Co., Ltd., Japan.
• The device may not work if the temperature and voltage conditions are different to
those defined in the specifications.
• If the device is stored at the maximum or minimum storage and transport temperature
and is moved to an environment with a temperature of 20°C, we recommend waiting
for approx. 30 minutes before using the device.
• The device fulfils the provisions of the European Standard EN13544-1:2007+A1:2009,
Respiratory therapy equipment - Part1: Nebulizing systems and their components.

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• IP classification is degrees of protection provided by enclosures in accordance with
IEC 60529. The compressor and the AC adapter are protected against solid foreign
objects of 12.5 mm diameter and greater such as a finger, and against vertically falling
water drops which may cause issues during a normal operation.
• See website of OMRON HEALTHCARE EUROPE to update technical information.
URL: www.omron-healthcare.com
• This device can be used for continuous operation.
• Please report to the manufacturer and the competent authority of the Member State in
which you are established about any serious incident that has occurred in relation to
this device.
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 ll
Protection against electric shock
IP XX
Ingress protection degree provided by IEC 60529
CE Marking
GOST-R symbol
Symbol of Eurasian Conformity
Serial number
Medical Device
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
or Power OFF or Stand-by
Power ON
Indication of connector polarity
For indoor use only
Fuse
Alternating current
Direct current
Date of manufacture YYYY-MM-DD
EN 60601-1;
IEC 60601-1
Certified by TÜV
Efficiency Level of power supply
Trademark of OMRON compressor nebulizers (COMP A-I-R,
COMP A-I-R basic, COMP A-I-R Elite, COMP A-I-R Pro)
Technology OMRON Healthcare Japan

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Indication of connector polarity
For indoor use only
Fuse
Alternating current
Direct current
Date of manufacture YYYY-MM-DD
EN 60601-1;
IEC 60601-1
Certified by TÜV
Efficiency Level of power supply
Trademark of OMRON compressor nebulizers (COMP A-I-R,
COMP A-I-R basic, COMP A-I-R Elite, COMP A-I-R Pro)
Technology OMRON Healthcare Japan

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Technical data for the OMRON C21 basic Compressor with the Nebulizer kit:
Particle Size: **MMAD 2.5μm - 4.5μm
MMAD = Mass Median Aerodynamic Diameter
Aerosol %< 5μm: 63% ± 10%
Medication Tank Capacity: 10ml maximum
Appropriate Medication Quantities: 2ml minimum - 10ml maximum
Residual volume of medication: 0.5 - 1.0ml
Sound: *Noise level (at 1 m distance) less than 45 dB
Nebulization Rate: *0.20 - 0.50ml/min
Aerosol Output: **0.37ml (2ml, 1%NaF)
Aerosol Output Rate: **0.05ml/min (2ml, 1%NaF)
Maximum permissible pressure inside the air tube: 400kPa
Result of cascade impactor measurements for particle size**
0
10
20
30
40
50
60
70
80
90
100
0.11 10 100
Cumulative % particle mass of sodium fluoride under size
Particle Size Dp (µm)
Cumulative Undersize %
Mean
Individual
* Measured by OMRON HEALTHCARE Co., Ltd. Measured with saline at ambient
temperature of 23°C and humidity of 40%. It may vary with the type of medication.
** Independently measured by Prof. Dr. Hiroshi Takano, Therapeutic Systems Research
Center, Doshisha University, Kyoto, Japan, according to EN13544-1:2007+A1:2009.
Note:
Performance may vary with medication such as suspensions or high viscosity. See
medication supplier’s data sheet for further details.