Omron NE-C101 Instruction Manual

Compressor Nebulizer
NE-C101
Model
Instruction Manual
4616584-0C
Issue Date: 2022-03-15
All for Healthcare
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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.
Baffle

How the nebulizer kit works

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medication is turned into fine particles I
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Compressed Air
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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
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EC IREPI
www.omron-healthcare.com
Importer in EU
Production facility OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.
Binh Duong Province, VIETNAM
Asia Pacific HQ OMRON HEALTHCARE SINGAPORE PTE LTD.
www.omronhealthcare-ap.com
Made in Vietnam

Intended use

Medical Purpose

This product is intended to be used for inhaling medication for respiratory
disorders.
The compressor is intended to be multiple patient multiple use. The
nebulizer kit and its attachments are single patient multiple use.

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 Kil 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.

Know your unit

Compressor (Main Unit)* Rear View
Air Tube
Power Switch
Connector Power Cord
Air Filter Cover
Including air filter
Ventilation Slots
n Ventilation Slots
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Nebulizer Kit* x 1 Mouthpiece* x 1 Nosepiece* x 1
Inhalation Top
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iR-m
Vaporizer Head
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Nozzle
Adult Mask (PVC)* x 1 Child Mask (PVC)* x 1
5
g-
Medication Tank
Air Tube Connector
Air Tube* Spare Air Filters x 2 Instruction Manual
(PVC, 100cm) x 1
Quick Start Guide
Warranty Card
• These parts comply with EN ISO 27427:2019

Important safety instructions

Read all the information in the instruction manual and any other literature included in
the box before using the device.
Indicate a p tentia y hazard u ituati n which, if not av ided, could re ult in
serious injury.
.A.
Warning: s o ll o s s o o s
(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.
min r or m derate injury, r phy ical damage.
Indicates a potentially hazardous situation which if not avoided, may result in
&Caution:
(Usage) o o o s
• 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.
• The nebulizer kit and its attachments are intended for use by a single patient. Do not
use by multiple patients; Use separate accessories for each patient.
(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.
• 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~60Hz
Power Consumption: 150VA
Current Fuse: T1.6AL250V
Operating Mode: Continuous Use
° °
Operating Temperature/ +5 C to +40 C / 15% to 85%RH (non-condensing)
Humidity/Air Pressure: 700 to 1060hPa
° °
Storage and Transport -20 C to +60 C 5% to 95%RH (non-condensing)
Temperature/Humidity: I
Weight: Approx. 1.05kg (compressor only)
Dimensions: Approx. 145 (W) x 124 (H) x182 (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 II (Protection against electric shock),
Type BF (Applied part); Mouthpiece, Nosepiece,
Mask, Warranty Card
IP21 (Ingress Protection)
Type of Medication Liquid: Solution, Suspension
Particle Size: **MMAD Approx. 3.90µm (2.5%NaF)
Medication Tank Capacity: 12ml maximum
Appropriate Medication 2ml minimum - 12ml maximum
Quantities:
Residual Volume: Approx. 0.7ml
Noise level *Less than 63dB
(at 1 m distance):
Nebulization Rate: *From 0.3ml/min (by weight loss)
Aerosol Output: 0.259ml (2ml, 1 %NaF)
Aerosol Output Rate: 0.05ml/min (2ml, 1 %NaF)
Percentage of Fill Volume 2.5%
Emitted Per Minute:
Result of cascade impactor measurements for particle size**
Cumulative % particle mass of sodium fluoride under size
100
I 1-:r
,'
35% 90
Particle size distribution
-
2µm � % � 5µm 47%
% >Sµm , I J
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% <2µm 18% 70
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Diameter (MMAD) : 3.9µm
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Ge metric Standard Deviati n
I (GSD): 1.9
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10
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0.1
0
10 100
Partic e Size Dp (µm)
* Measured by OMRON HEALTHCARE Co., Ltd. l
** Measured values reflect internal data obtained by NEXT GENERATION IMPACTOR
(NGI), according to EN13544-1 :2007 + A 1 :2009 and ISO27427:2013.
• Subject to technical modification without prior notice.
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.
• 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 European Standard EN 13544-1 :2007 +A 1 :2009,
Respiratory therapy equipment - Part1: Nebulizing systems and their componentsand
EN ISO 27427:2019 Anaesthetic and respiratory equipment - Nebulizing systems and
components.
• Performance may vary with medication such as suspensions or high viscosity. See
medication supplier's data sheet for further details.
• The particle size distribution and aerosol output may vary by combination of product,
medication and ambient conditions such as temperature, humidity and atmospheric
pressure.
• The disclosures for nebulizer performance are based upon testing that utilizes adult
ventilatory patterns and are likely to be different from those stated for paediatric or
infant populations.
• 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.
• 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.
CE 0197
Symbols description
Need for the user to follow this
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e, instruction manual thoroughly Temperature limitation
for your safety.
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Need for the user to consult
Humidity limitation
the instructions for use
O]
Applied part - Type BF
Atmospheric pressure
Degree of protection against
B
[!] limitation
electric shock (leakage current)
Class II
Protection against electric Power OFF
0
shock
Ingress protection degree
Power ON
provided by IEC 60529
I
IPXX
CE Marking Alternating current
CE:
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Serial number Date of manufacture
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Medical Device
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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 ii 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.
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