Omron NE-C101 Instruction Manual

EN

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
NE-C101 and the content of 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
saline 3 times a day for 10 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) 1 year
Air Filter 60 days
Mask (PVC) 1 year

Precautions for use

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

NE-C101-AP_C_M03_180222.pdf

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. The compressor could get hot and there is a possible risk of a burn if touched.

• Always dispose of any remaining medication after use, and use fresh medication each time.

•Do not use in anaesthetic or ventilator breathing circuits.

•Do not block the ventilation slots. Never place the device where the ventilation slots

may be obstructed during operation. The compressor could get hot and there is a
possible risk of a burn if touched.

•Store the 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. Do not spill water or other liquids

on these parts. If liquid does spill on these parts, immediately unplug the

power cord

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.

(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 the parts.

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 being 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 30 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 12 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 distort the vaporizer head, or 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 power cord.

•Do not leave the device in extreme hot or cold temperature, 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.

•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 block the slit between the cap and the inhalation air inlet.

•Make sure that the vaporizer head is correctly installed before use.

•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 device 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.

•Do not wind the power cord around the compressor.

•Changes or modifications not approved by OMRON HEALTHCARE will void the user

warranty.

•Do not pull the power cord strongly.

(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.

Thank you for purchasing the 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 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 compressed air mixed with
medication is turned into fine particles
and sprayed when in contact with the
baffle.

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 HEALTHCARE MANUFACTURING VIETNAM CO., LTD.

Binh Duong Province, VIETNAM

Asia Pacific HQ OMRON HEALTHCARE SINGAPORE PTE LTD.

438A Alexandra Road, #05-05/08
Alexandra Technopark, Singapore 119967
www.omronhealthcare-ap.com

Made in Vietnam

•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.

•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 and parts before using them each time, and check that there are
no problems. In particular, be sure to check the following:

- That the 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. Twist the air tube plug slightly when inserting it into the air
tube connectors to avoid the air tube disconnecting during use.

•To completely isolate the device from the power source unplug the plug from the
power source.

•Using the device longer than the standard operating time for which it was designed
may result in accidents such as fire or injury due to deterioration over time.

Keep these instructions for future reference.

Technical data

Product Category: Nebulizers
Product Description: Compressor Nebulizer
Model: NE-C101
Rating: 230V

50Hz
Power Consumption: 150VA
Current Fuse: T1.6AL250V
Operating Mode: Continuous Use
Operating Temperature/
Humidity/Air Pressure:

+5°C to +40°C / 15% to 85%RH (non-condensing)

700 to 1060hPa
Storage and Transport
Temperature/Humidity:

-20°C to +60°C / 5% to 95%RH (non-condensing)

Weight: Approx. 1.05kg (compressor only)
Dimensions: Approx. 145 (W) × 124 (H) ×182 (D) mm

(compressor only)
Contents:

Compressor, Nebulizer Kit, Air Tube (PVC,

100cm), Mouthpiece, Nosepiece, Adult Mask

(PVC), Child Mask (PVC), 2 pcs Spare Air Filters,

Instruction Manual, Quick Start Guide.

Classification: Class ll (Protection against electric shock),

Type BF (Applied part); Mouthpiece, Nosepiece,

Mask

IP21 (Ingress Protection)

Technical data for the NE-C101 Compressor:
Particle Size: **MMAD Approx. 3.90µm

MMAD = Mass Median Aerodynamic Diameter
Medication Tank Capacity: 12ml maximum
Appropriate Medication
Quantities:

2ml minimum - 12ml maximum

Noise level
(at 1m distance):

*Less than 63dB

Nebulization Rate: *Approx. 0.3ml/min (by weight loss)
Aerosol Output: 0.259ml (2ml, 1%NaF)
Aerosol Output Rate: 0.05ml/min (2ml, 1%NaF)

Result of cascade impactor measurements for particle size**

Cumulative % particle mass of sodium fluoride under size

Particle Size Dp (µm)

Cumulative Undersize %

0

10

20

30

40

50

60

70

80

90

100

0.1110 100

Individual tests

Mean

MMAD:3.9μm

* Measured by OMRON HEALTHCARE Co., Ltd.
** Measured values reflect internal data obtained by NEXT GENERATION IMPACTOR

(NGI), according to EN13544-1:2007 + A1:2009 and ISO27427:2013.

Notes:

•Subject to technical modification without prior notice.

•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.

•Ensure that this device has acclimated to room temperature before nebulizing the
medication. Nebulizing the medication after an extreme temperature change could
lead to less nebulization. OMRON recommends waiting for approximately 2 hours
for the device to warm up or cool down when the device is used at an environment
within the temperature specified as operating conditions after it is stored either at
the maximum or at the minimum storage temperature. For additional information of
operating and storage/transport temperature, refer to Technical data.

•The device fulfils the provisions of the EC directive 93/42/EEC (Medical Device
Directive) and the European Standard EN13544-1:2007+A1:2009, Respiratory
therapy equipment - Part1: Nebulizing systems and their components.

•Performance may vary with medication such as suspensions or high viscosity. See
medication supplier’s data sheet for further details.

•IP classification is degrees of protection provided by enclosures in accordance with
IEC 60529. The device is protected against solid foreign objects of 12.5mm diameter
and greater such as finger and against vertically falling water drops which may cause
issues during a 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 ll
Protection against electric shock

IPXX

Ingress protection degree provided by IEC 60529

CE Marking

Serial number

Temperature limitation

Humidity limitation

Atmospheric pressure limitation

Power OFF

Power ON

Alternating current

Product production date is integrated in the Serial number, which placed on the
product and/or sales package: the first 4 digits mean year of production, the next
2 digits mean month of production.

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 waste for disposal.

Know your unit

Optional Medical Accessories

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

Product description Model

Nebulizer Kit NEB-NK-11AP

Nebulizer Kit & Adult Mask & Air Tube Set NEB-NSET4-11AP

Nebulizer Kit & Child Mask & Air Tube Set NEB-NSET5-11AP

Adult Mask (PVC) NEB-MSLP-AP

Child Mask (PVC) NEB-MSMP-AP

Mouthpiece NEB-MP-AP

Nosepiece NEB-NP-AP

Air Tube (PVC, 100cm) NEB-TP-L10AP

Other Optional/Replacement Parts

Product description Model

Air Filters x 5 NEB-AFR-30AP

Compressor Nebulizer

Model

NE-C101

Instruction Manual

Baffle

Aerosol

Medication
Channel

Medication

Aerosol

Nozzle

Medication

Compressed Air

2829198-6C

12M3148

Nebulizer Kit x 1 Nosepiece x 1Mouthpiece x 1

Adult Mask (PVC) x 1

Child Mask (PVC) x 1

Air Tube
(PVC, 100cm) x 1

Instruction Manual

Quick Start Guide

Spare Air Filters x 2

Compressor (Main Unit)

Power Switch

Air Tube
Connector

Air Filter Cover
Including air filter

Nebulizer Kit
Holder

Ventilation Slots

Rear View

Power Cord

Ventilation Slots

Power Plug

Air Tube Connector

Inhalation Top

Vaporizer Head

Medication Tank

Nozzle

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. Remove the air filter cover using a flat screwdriver
as shown on the right.

2. Change the air filter.
Remove the old air filter and insert the new 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 a filter.

•Do not wash or clean the 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.

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 turned on.

Is the power plug plugged into
a power outlet?

Check that the plug is inserted
in a power 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?

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
30 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 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 covered?

Do not cover the compressor with
any type of cover during use.

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

- the device are not user serviceable. Please contact an authorized OMRON
representative for assistance.

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, Mask (PVC), 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 (PVC)

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 below.

o

: applicable X: not applicable

Disinfecting

method

Parts

Mouthpiece

Nosepiece

Nebulizer Kit

Adult Mask (PVC)

Child Mask (PVC)

Air Tube

(PVC, 100cm)

Air Filter

Materials

PPPPPP

Mask: PVC

(Phthalate free)

Band: Rubber***

PVC

(Phthalate free)

Polyester

A

Alcohol

o o o o

**

X X

Disinfecting

ethanol

Sodium

hypochlorite

o o o o

**

X X

Milton*

(0.1%, 15min.)

Quaternary
ammonium

o o o o

**

X X

Osvan*

(0.1%, 10min.)

Chlorhexidine

o o o o

**

X X

Hibitane*

(0.5%, 30min.)

Amphoteric

Surfactant

o o o o

**

X X

Tego 51*

(0.2%, 15min.)

B

Boiling

o o o

X X X

* 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 not made with natural rubber-latex.

A. Use a commercially available disinfectant. Follow the instructions

provided by the disinfectant manufacturer.

Note: Never clean with benzene, thinner or a flammable

chemical.

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.

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.

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.

1

2

4.

Add the correct amount of prescribed medication to the

medication tank.

5.

Make sure that the vaporizer head is placed in the

medication tank.

6.

Put the inhalation top back onto the medication tank.

1) Lower the inhalation top on the medication tank.

2) Rotate the inhalation top clockwise.

1

2

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 below.

Follow the instructions of your doctor or respiratory therapist.

Caution:

Do not tilt the nebulizer kit at an angle of greater than 30 degrees in all
directions. Medication may flow into the mouth or it may result in not
nebulizing effectively.

Right angle

10.

Turn 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 and

unplug the compressor from the power outlet.

Important information regarding Electro Magnetic Compatibility (EMC)

NE-C101 manufactured by OMRON HEALTHCARE Co., Ltd. conforms to
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 web site.